nct_id stringlengths 11 11 | endpoint_role stringclasses 2
values | endpoint_index int64 0 213 | endpoint_raw stringlengths 2 255 | endpoint_domain stringclasses 12
values | endpoint_measure_type stringclasses 10
values | endpoint_canonical stringclasses 38
values | endpoint_direction stringclasses 4
values | endpoint_domain_inferred bool 2
classes | endpoint_measure_inferred bool 2
classes | normalization_confidence float64 0 1 | timeframe_raw stringlengths 2 255 | horizon_days float64 0 61.3k β | timepoint_count float64 1 46 β | is_longitudinal bool 2
classes | baseline_anchored bool 2
classes | timeframe_confidence float64 0 0.9 | phase stringclasses 7
values | study_type stringclasses 2
values | overall_status stringclasses 6
values | has_results bool 1
class | enrollment_count int64 1 19.9M | enrollment_type stringclasses 2
values | condition_primary stringlengths 3 159 | conditions_all stringlengths 3 3.76k | intervention_types stringclasses 688
values | intervention_names stringlengths 3 977 β | lead_sponsor stringlengths 4 120 | sponsor_class stringclasses 8
values | start_date stringlengths 7 10 | completion_date stringlengths 7 10 | results_first_posted stringdate 2020-05-05 00:00:00 2026-09-08 00:00:00 | allocation stringclasses 2
values | masking stringclasses 5
values | primary_purpose stringclasses 9
values |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
NCT04761055 | primary | 0 | Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations (CBE)by Estimating the Sensitivity of the Device Using Imaging Results | diagnostic_accuracy | diagnostic_accuracy | null | unspecified | false | false | 0.72 | approximately one month after imaging scan | null | null | null | false | 0 | null | INTERVENTIONAL | COMPLETED | true | 300 | ACTUAL | Breast Screening | Breast Screening | OTHER; DEVICE; DIAGNOSTIC_TEST | Clinical Breast exam (CBE); iBreastExam device; mammogram | Memorial Sloan Kettering Cancer Center | OTHER | 2021-01-29 | 2025-08-19 | 2026-07-30 | null | NONE | DIAGNOSTIC |
NCT04761055 | primary | 1 | Compare the Outcomes of the iBE Examinations to Clinical Breast Examinations by Estimating the Specificity of the Device Using Imaging Results | diagnostic_accuracy | diagnostic_accuracy | null | unspecified | false | false | 0.72 | approximately one month after imaging scan | null | null | null | false | 0 | null | INTERVENTIONAL | COMPLETED | true | 300 | ACTUAL | Breast Screening | Breast Screening | OTHER; DEVICE; DIAGNOSTIC_TEST | Clinical Breast exam (CBE); iBreastExam device; mammogram | Memorial Sloan Kettering Cancer Center | OTHER | 2021-01-29 | 2025-08-19 | 2026-07-30 | null | NONE | DIAGNOSTIC |
NCT05823948 | primary | 0 | Change in Glycosylated Haemoglobin (HbA1c) | biomarker_laboratory | change_from_baseline | hba1c_change | lower_is_better | true | false | 1 | Baseline (week 0), week 26 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 51 | ACTUAL | Diabetes Mellitus, Type 2 | Diabetes Mellitus, Type 2 | DRUG | Insulin Icodec | Novo Nordisk A/S | INDUSTRY | 2023-04-11 | 2024-04-11 | 2026-04-30 | null | NONE | TREATMENT |
NCT05381948 | primary | 0 | Average Change in Best Corrected Visual Acuity (BCVA) From Baseline Averaged Over Weeks 28 and 32 | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline (Day 1) and Weeks 28 and 32 | null | null | null | true | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 0 | Change From Baseline in Best Corrected Visual Acuity up to Week 56 | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline (Day 1) and Weeks 32 and 56 | null | null | null | true | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 1 | Percentage of Subjects With >=5, >=10, and >=15 BCVA Letter Change From Baseline up to Week 56 | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline (Day 1) and Weeks 32 and 56 | null | null | null | true | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 2 | Percentage of Subjects Not Receiving Supplemental Injection of Aflibercept up to Week 56 | unclassified | proportion | null | unspecified | false | false | 0.34 | Weeks 32 and 56 | null | null | null | false | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 3 | Median Time to First Supplemental Aflibercept Injection in the Study Eye Following the EYP-1901 Dose at Week 8 | unclassified | time_to_event | null | unspecified | false | false | 0.368 | From Week 8 to Week 56 | null | null | null | false | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 4 | Number of Aflibercept Intravitreal Injections up to Week 56 (Including Loading Dose) | unclassified | count | null | unspecified | false | false | 0.32 | Weeks 32 and 56 | null | null | null | false | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 5 | Mean Change From Baseline in Central Subfield Thickness (CST) by Spectral-Domain - Optical Coherence Tomography (SD-OCT) up to Week 56 | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline (Day 1) and Weeks 32 and 56 | null | null | null | true | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 6 | Change From Baseline in Height of Subretinal Fluid by Spectral-Domain - Optical Coherence Tomography up to Week 56 | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline (Day 1) and Weeks 32 and 56 | null | null | null | true | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 7 | Percentage of Subjects With No Detectable Intraretinal Fluid/Cysts in the Central Subfield up to Week 56 | unclassified | proportion | null | unspecified | false | false | 0.34 | Weeks 32 and 56 | null | null | null | false | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 8 | Change From Baseline in Total Lesion Area by Fluorescein Angiography (FA) up to Week 56 | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline (Day 1) and Weeks 32 and 56 | null | null | null | true | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 9 | Change From Baseline in Total Choroidal Neovascularization Area by Fluorescein Angiography up to Week 56 | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline (Day 1) and Weeks 32 and 56 | null | null | null | true | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 10 | Systemic Exposure to EYP-1901 Measured Through Plasma Levels up to Week 56 | biomarker_laboratory | concentration | null | unspecified | false | false | 0.6 | Up to Week 56 | null | null | null | false | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 11 | Ocular Exposure to EYP-1901 Measured Through Aqueous Humor (AH) Levels up to Week 32 | unclassified | concentration | null | unspecified | false | false | 0.28 | Up to Week 32 | null | null | null | false | 0 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT05381948 | secondary | 12 | Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Treatment-Emergent Adverse Events up to Week 56 | safety | count | adverse_event_incidence | lower_is_better | true | false | 0.96 | From the study drug administration (Day 1) up to end of the study, approximately 56 weeks. | 392 | 1 | false | false | 0.9 | PHASE2 | INTERVENTIONAL | COMPLETED | true | 161 | ACTUAL | Wet Age-related Macular Degeneration | Wet Age-related Macular Degeneration | DRUG; DRUG | EYP-1901; Aflibercept 2mg/0.05mL Inj,Oph | EyePoint Pharmaceuticals, Inc. | INDUSTRY | 2022-06-30 | 2024-04-24 | 2025-10-02 | RANDOMIZED | TRIPLE | TREATMENT |
NCT04050540 | primary | 0 | Incidence of N. Gonorrhoeae, C. Trachomatis, or Early Syphilis Infection by Laboratory-based Diagnosis | immunogenicity | proportion | null | lower_is_better | false | false | 0.7 | 12 months post enrolment | 365.28 | 1 | false | false | 0.9 | PHASE4 | INTERVENTIONAL | COMPLETED | true | 449 | ACTUAL | HIV Infections | HIV Infections; HIV/AIDS; Neisseria Gonorrheae Infection; Chlamydia Trachomatis Infection; Syphilis Infection | DRUG | Doxycycline | University of Washington | OTHER | 2020-02-05 | 2022-10-30 | 2024-07-10 | RANDOMIZED | NONE | PREVENTION |
NCT04810091 | primary | 0 | Percent Change in NTproBNP at 6 Months Visit From Baseline | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline and at 6 months | 182.64 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 0 | Change in 6MWT at 3 Month Visit | behavioral_functional | change_from_baseline | null | unspecified | false | false | 0.672 | Baseline and 3 month follow-up | 91.32 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 1 | Change in 6MWT at 6 Month Visit | behavioral_functional | change_from_baseline | null | unspecified | false | false | 0.672 | Baseline and 6 month follow-up | 182.64 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 2 | Change in CVHD % Score From Baseline to 3 Month Visit | efficacy | change_from_baseline | null | ambiguous | false | false | 0.66 | Baseline and 3 month follow-up | 91.32 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 3 | Change in CVHD Score From Baseline to 6 Month Visit | efficacy | change_from_baseline | null | ambiguous | false | false | 0.66 | Baseline and 6 month follow-up | 182.64 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 4 | Percentage of Participants With Significant Change in Strain-RV From Baseline at 3 Months | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline and 3 month follow-up | 91.32 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 5 | Percentage of Participants With Significant Change in Strain-RV From Baseline at 6 Months | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline and 6 month follow-up | 182.64 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 6 | Percentage of Participants With Significant Change in Strain-LV From Baseline at 3 Months | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline and 3 month follow-up | 91.32 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 7 | Percentage of Participants With Significant Change in Strain-LV From Baseline at 6 Months | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline and 6 month follow-up | 182.64 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 8 | Percentage of Participants With Normal TAPSE at 3 Months | clinical_assessment | proportion | blood_pressure | unspecified | true | false | 0.98 | 3 month follow-up | 91.32 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 9 | Percentage of Participants With Normal TAPSE at 6 Months | clinical_assessment | proportion | blood_pressure | unspecified | true | false | 0.98 | 6 month follow-up | 182.64 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 10 | Change in 5HIAA From Baseline to 3 Months | biomarker_laboratory | change_from_baseline | null | unspecified | false | false | 0.68 | Baseline and 3 month follow-up | 91.32 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 11 | Change in 5HIAA From Baseline to 6 Months | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline and 6 month follow-up | 182.64 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 12 | Change in Troponin From Baseline to 3 Months | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline and 3 months follow-up | 91.32 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 13 | Change in Troponin From Baseline to 6 Months | unclassified | change_from_baseline | null | unspecified | false | false | 0.36 | Baseline and 6 months follow-up | 182.64 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 14 | Change in MDASI Mean Core Symptom Score From Baseline to 3 Months | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline and 3 months follow-up | 91.32 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 15 | Change in Core Symptom Score From Baseline to 6 Months | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline and 6 months follow-up | 182.64 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 16 | Change in MDASI Mean Total Symptom Score From Baseline to 3 Months | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline and 3 months follow-up | 91.32 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 17 | Change in MDASI Mean Total Symptom Score From Baseline to 6 Months | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline and 6 months follow-up | 182.64 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 18 | Change in MDASI Mean Interference Score From Baseline to 3 Months | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline and 3 months follow-up | 91.32 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 19 | Change in Interference Score From Baseline to 6 Months | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline and 6 months follow-up | 182.64 | 1 | false | true | 0.9 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04810091 | secondary | 20 | Compliance>=70% While the Patients Were in the Study | healthcare_utilization | proportion | null | unspecified | false | false | 0.66 | Baseline, 3 months follow-up, 6 months follow-up | 182.64 | 2 | true | true | 0.65 | PHASE3 | INTERVENTIONAL | ACTIVE_NOT_RECRUITING | true | 79 | ACTUAL | Locally Advanced Neuroendocrine Neoplasm | Locally Advanced Neuroendocrine Neoplasm; Metastatic Neuroendocrine Neoplasm | DRUG; OTHER; DRUG | Placebo Administration; Questionnaire Administration; Telotristat Ethyl | M.D. Anderson Cancer Center | OTHER | 2021-05-18 | 2026-08-03 | 2026-02-05 | RANDOMIZED | NONE | TREATMENT |
NCT04280562 | primary | 0 | Change in Neuropathic Pain Symptom Inventory (NPSI) | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | primary | 1 | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 1: Burning Pain | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | primary | 2 | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 2: Pressing Pain | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | primary | 3 | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 3: Paroxysmal Pain | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | primary | 4 | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 4: Evoked Pain | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | primary | 5 | Change in Neuropathic Pain Symptom Inventory (NPSI) Subscale 5: Paresthesia or Dysesthesia | unclassified | change_from_baseline | null | lower_is_better | false | false | 0.36 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | secondary | 0 | Change in Patient Health Questionnaire Type 9 for Depression (PHQ-9) | patient_reported | change_from_baseline | depression_score | lower_is_better | true | false | 1 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | secondary | 1 | Change in Pittsburgh Sleep Quality Index (PSQI) | behavioral_functional | change_from_baseline | null | unspecified | false | false | 0.672 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | secondary | 2 | Change in Beck Depression Inventory (BDI) | patient_reported | change_from_baseline | depression_score | lower_is_better | true | false | 1 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | secondary | 3 | Change in General Anxiety Disorder 7-item Questionnaire (GAD-7) | patient_reported | change_from_baseline | anxiety_score | lower_is_better | true | false | 1 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | secondary | 4 | Change in World Health Organization Quality of Life Pain (WHOQOL-pain) - Pain Facet | patient_reported | change_from_baseline | quality_of_life | ambiguous | true | false | 1 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | secondary | 5 | Change in World Health Organization Quality of Life Bref (WHOQOL-BREF) | patient_reported | change_from_baseline | quality_of_life | higher_is_better | true | false | 1 | Baseline 1(Week0); Baseline 2 (Week 2); Post-assessment (Week 10); Follow up (Week 14) | null | null | null | true | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | secondary | 6 | Change in Patient's Global Impression of Change (PGIC) | patient_reported | change_from_baseline | pain_score | ambiguous | true | false | 1 | Post-assessment (Week 10); Follow up (Week 14) | null | null | null | false | 0 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | secondary | 7 | Visual Analogue Scale (VAS)-Pain | patient_reported | score_scale | pain_score | lower_is_better | true | false | 0.96 | before and after each time device used up to 14 weeks | 98 | 1 | false | false | 0.9 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT04280562 | secondary | 8 | Visual Analogue Scale (VAS)-Sleep | patient_reported | change_from_baseline | null | unspecified | false | false | 0.7 | first 3 days and 14 weeks | 98 | 2 | true | false | 0.65 | null | INTERVENTIONAL | COMPLETED | true | 75 | ACTUAL | Neuropathic Pain | Neuropathic Pain; Chronic Pain; Pain | DEVICE; DEVICE | Sana Pain Reliever; Sham SPR | Icahn School of Medicine at Mount Sinai | OTHER | 2020-01-31 | 2023-02-21 | 2025-07-09 | RANDOMIZED | DOUBLE | TREATMENT |
NCT05004662 | primary | 0 | Self-Reported 7-Day Point-Prevalence Smoking Abstinence | behavioral_functional | unclassified | null | unspecified | false | false | 0.312 | 12 Month Follow-Up | 365.28 | 1 | false | false | 0.9 | null | INTERVENTIONAL | COMPLETED | true | 502 | ACTUAL | Smoking Cessation | Smoking Cessation | BEHAVIORAL; DRUG; BEHAVIORAL; DRUG | Smartphone-delivered automated treatment; Nicotine patch; Counseling; Nicotine lozenge | H. Lee Moffitt Cancer Center and Research Institute | OTHER | 2021-12-01 | 2025-08-19 | 2026-08-04 | RANDOMIZED | NONE | PREVENTION |
NCT05004662 | secondary | 0 | Biochemical Verification Via Salivary Cotinine | behavioral_functional | unclassified | null | unspecified | false | false | 0.312 | 12 Month Follow-Up | 365.28 | 1 | false | false | 0.9 | null | INTERVENTIONAL | COMPLETED | true | 502 | ACTUAL | Smoking Cessation | Smoking Cessation | BEHAVIORAL; DRUG; BEHAVIORAL; DRUG | Smartphone-delivered automated treatment; Nicotine patch; Counseling; Nicotine lozenge | H. Lee Moffitt Cancer Center and Research Institute | OTHER | 2021-12-01 | 2025-08-19 | 2026-08-04 | RANDOMIZED | NONE | PREVENTION |
NCT05004662 | secondary | 1 | Self-Reported 24-Hour Point-Prevalence Smoking Abstinence | behavioral_functional | count | null | unspecified | false | false | 0.632 | 12 Month Follow-Up | 365.28 | 1 | false | false | 0.9 | null | INTERVENTIONAL | COMPLETED | true | 502 | ACTUAL | Smoking Cessation | Smoking Cessation | BEHAVIORAL; DRUG; BEHAVIORAL; DRUG | Smartphone-delivered automated treatment; Nicotine patch; Counseling; Nicotine lozenge | H. Lee Moffitt Cancer Center and Research Institute | OTHER | 2021-12-01 | 2025-08-19 | 2026-08-04 | RANDOMIZED | NONE | PREVENTION |
NCT05004662 | secondary | 2 | Self-Reported 30-Day Point-Prevalence Smoking Abstinence | behavioral_functional | count | null | unspecified | false | false | 0.632 | 12 Month Follow-Up | 365.28 | 1 | false | false | 0.9 | null | INTERVENTIONAL | COMPLETED | true | 502 | ACTUAL | Smoking Cessation | Smoking Cessation | BEHAVIORAL; DRUG; BEHAVIORAL; DRUG | Smartphone-delivered automated treatment; Nicotine patch; Counseling; Nicotine lozenge | H. Lee Moffitt Cancer Center and Research Institute | OTHER | 2021-12-01 | 2025-08-19 | 2026-08-04 | RANDOMIZED | NONE | PREVENTION |
NCT04181762 | primary | 0 | Percentage of Participants Achieving Complete Renal Response (CRR) at Week 52 | biomarker_laboratory | proportion | null | unspecified | false | false | 0.66 | Baseline, Week 52 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 0 | Change From Baseline in 24-hour Urine Protein-to Creatinine Ratio (UPCR) | biomarker_laboratory | change_from_baseline | null | unspecified | false | false | 0.68 | Baseline, Week 52 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 1 | Percentage of Participants Achieving Partial Renal Response (PRR) at Week 52 | efficacy | proportion | null | unspecified | false | false | 0.64 | Baseline, Week 52 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 2 | Average Daily Dose of Oral Corticosteroids | efficacy | unclassified | null | higher_is_better | false | false | 0.3 | Week 16 to Week 52 | null | null | null | false | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 3 | Percentage of Participants Achieving Partial Renal Response (PRR) at Week 24 | efficacy | proportion | null | unspecified | false | false | 0.64 | Baseline, Week 24 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 4 | Incidence Rate of Participants Achieving Complete Renal Response (CRR) up to Week 52 | unclassified | time_to_event | null | unspecified | false | false | 0.368 | Baseline to Week 52 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 5 | Incidence Rate of Participants Achieving Partial Renal Response (PRR) up to Week 52 | unclassified | time_to_event | null | unspecified | false | false | 0.368 | Baseline to Week 52 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 6 | Time to Achieve First Morning Void Urine Protein-to-Creatinine Ratio (UPCR) <= 0.5 mg/mg up to Week 52 | biomarker_laboratory | time_to_event | null | unspecified | false | false | 0.688 | Baseline to Week 52 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 7 | Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-Fatigue) Mean Change From Baseline up to Week 52 | patient_reported | change_from_baseline | null | unspecified | false | false | 0.7 | Baseline, Week 12, Week 24, Week 36, Week 52 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 8 | Short Form Health Survey (SF-36) Version 2 (Acute Form) Mean Change From Baseline in Physical Component Score (PCS) up to Week 52 | patient_reported | change_from_baseline | quality_of_life | ambiguous | true | false | 1 | Baseline, Week 12, Week 24, Week 36, Week 52 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 9 | Lupus Quality of Life (LupusQoL) Physical Health Score Mean Change From Baseline up to Week 52 | patient_reported | change_from_baseline | quality_of_life | ambiguous | true | false | 1 | Baseline, Week 12, Week 24, Week 36, Week 52 | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 10 | Incidence of Adverse Events (AEs), Serious Adverse Events (SAEs) | safety | proportion | adverse_event_incidence | lower_is_better | true | false | 0.98 | From first dose of study treatment up to approximately 2 years | 730.5 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 11 | Percentage of Participants With Complete Renal Response (CRR) at Week 104 Within Those Who Had Achieved CRR at Week 52 in the Secukinumab Group | unclassified | proportion | null | unspecified | false | false | 0.34 | Week 52 to Week 104 | null | null | null | false | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT04181762 | secondary | 12 | Percentage of Participants With Improved or Maintained Response (PRR or CRR) at Week 104 in Those Who Had Achieved at Least PRR at Week 52 in the Secukinumab Group | unclassified | proportion | null | unspecified | false | false | 0.34 | Week 52 to Week 104 | null | null | null | false | 0 | PHASE3 | INTERVENTIONAL | TERMINATED | true | 275 | ACTUAL | Lupus Nephritis | Lupus Nephritis | DRUG; DRUG | secukinumab; Placebo | Novartis Pharmaceuticals | INDUSTRY | 2020-07-07 | 2023-09-13 | 2024-10-10 | RANDOMIZED | QUADRUPLE | TREATMENT |
NCT06911242 | primary | 0 | AUC0-t | pharmacokinetics | pk_parameter | pk_exposure | unspecified | true | false | 1 | From time zero (dose) to time of last quantifiable concentration. Period 1: 0 to 144 hours; Period 2: 0 to 168 hours. | 7 | 2 | true | false | 0.65 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT06911242 | primary | 1 | AUC0-24 | pharmacokinetics | pk_parameter | pk_exposure | unspecified | true | false | 1 | From time zero (dose) to 24 hours post-dose. | 1 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT06911242 | primary | 2 | AUC0-β | pharmacokinetics | pk_parameter | pk_exposure | unspecified | true | false | 1 | From time zero (dose) extrapolated to infinity. Time frame is from 0 to Tlast + extrapolation from C last to infinity time, where concentration is equal to 0. | null | null | null | false | 0 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT06911242 | primary | 3 | Cmax | pharmacokinetics | pk_parameter | pk_exposure | unspecified | true | false | 1 | From time 0 (dose) through 168 hours post-dose. | 7 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT06911242 | primary | 4 | Tmax | pharmacokinetics | time_to_event | pk_exposure | unspecified | true | false | 1 | From time 0 (dose) through 168 hours post-dose. | 7 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT06911242 | primary | 5 | t1/2 | pharmacokinetics | pk_parameter | pk_exposure | unspecified | true | false | 1 | From time 0 (dose) through 168 hours post-dose (terminal elimination phase). | 7 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT06911242 | primary | 6 | CL/F | pharmacokinetics | pk_parameter | null | unspecified | false | false | 0.748 | From time 0 (dose) through 168 hours post-dose (derived from the concentration-time profile). | 7 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT06911242 | primary | 7 | Vz/F | unclassified | pk_parameter | null | unspecified | false | false | 0.368 | From time 0 (dose) through 168 hours post-dose (derived from the concentration-time profile). | 7 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT06911242 | secondary | 0 | Participants With β₯1 TEAE | safety | count | adverse_event_incidence | lower_is_better | true | false | 0.96 | From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs). | 7 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT06911242 | secondary | 1 | Participants With β₯1 TESAE | safety | count | serious_adverse_events | lower_is_better | true | false | 0.96 | From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs). | 7 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT06911242 | secondary | 2 | Participants With Study Drug-related TEAEs of Grade >1 | safety | count | adverse_event_incidence | unspecified | true | false | 0.96 | From first dose through approximately 7 days after the last dose (includes washout); with Day 36 follow-up phone call to assess for any adverse events (AEs). | 7 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | COMPLETED | true | 16 | ACTUAL | Healthy Volunteer | Healthy Volunteer; Pharmacokinetics After Oral Intake | DRUG | ARN-75039 | Arisan Therapeutics, Inc. | INDUSTRY | 2025-02-27 | 2025-04-21 | 2026-05-01 | RANDOMIZED | NONE | BASIC_SCIENCE |
NCT04435808 | primary | 0 | SARS-CoV-2 Infection | unclassified | count | null | unspecified | false | false | 0.32 | 3 months | 91.32 | 1 | false | false | 0.9 | PHASE1; PHASE2 | INTERVENTIONAL | TERMINATED | true | 1 | ACTUAL | COVID-19 | COVID-19 | DRUG | Hydroxychloroquine | University of New Mexico | OTHER | 2020-04-14 | 2020-07-15 | 2020-11-16 | NON_RANDOMIZED | NONE | PREVENTION |
NCT05831189 | primary | 0 | Number of Participants With RBX2660-related Treatment-emergent Adverse Events (TEAEs) After RBX2660 Treatment Delivered by Colonoscopy Through 8 Weeks, or Treatment Failure | safety | count | adverse_event_incidence | lower_is_better | true | false | 0.96 | 8 weeks after RBX2660 treatment delivered by colonoscopy | 56 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 41 | ACTUAL | Clostridium Difficile Infection Recurrence | Clostridium Difficile Infection Recurrence | DRUG | RBX2660 | Ferring Pharmaceuticals | INDUSTRY | 2023-04-21 | 2025-01-17 | 2026-04-24 | null | NONE | TREATMENT |
NCT05831189 | secondary | 0 | Number of Participants With Recurrence of Clostridioides Difficile Infection (CDI) Within 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy. | efficacy | count | null | lower_is_better | false | false | 0.62 | Within 8 weeks after RBX2660 treatment delivered by colonoscopy | 56 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 41 | ACTUAL | Clostridium Difficile Infection Recurrence | Clostridium Difficile Infection Recurrence | DRUG | RBX2660 | Ferring Pharmaceuticals | INDUSTRY | 2023-04-21 | 2025-01-17 | 2026-04-24 | null | NONE | TREATMENT |
NCT05831189 | secondary | 1 | Time to CDI Recurrence From Baseline Through 8 Weeks After RBX2660 Treatment Delivered by Colonoscopy | efficacy | time_to_event | null | lower_is_better | false | false | 0.668 | 8 weeks after RBX2660 treatment delivered by colonoscopy | 56 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 41 | ACTUAL | Clostridium Difficile Infection Recurrence | Clostridium Difficile Infection Recurrence | DRUG | RBX2660 | Ferring Pharmaceuticals | INDUSTRY | 2023-04-21 | 2025-01-17 | 2026-04-24 | null | NONE | TREATMENT |
NCT05831189 | secondary | 2 | Physician-experience, as Determined by Questionnaire, Documenting Subjective Experience of Investigators on Usability of RBX2660 in Clinical Practice When Delivered by Colonoscopy | patient_reported | score_scale | null | unspecified | false | false | 0.66 | At Day 1 (baseline visit) | null | null | null | true | 0 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 41 | ACTUAL | Clostridium Difficile Infection Recurrence | Clostridium Difficile Infection Recurrence | DRUG | RBX2660 | Ferring Pharmaceuticals | INDUSTRY | 2023-04-21 | 2025-01-17 | 2026-04-24 | null | NONE | TREATMENT |
NCT05831189 | secondary | 3 | Physician Perception of Patient Benefit, as Determined by Number of Participants With Clinician Global Impression of Improvement (CGI-I) at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy | efficacy | count | null | ambiguous | false | false | 0.62 | 8 weeks after RBX2660 treatment delivered by colonoscopy | 56 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 41 | ACTUAL | Clostridium Difficile Infection Recurrence | Clostridium Difficile Infection Recurrence | DRUG | RBX2660 | Ferring Pharmaceuticals | INDUSTRY | 2023-04-21 | 2025-01-17 | 2026-04-24 | null | NONE | TREATMENT |
NCT05831189 | secondary | 4 | Patient-experience Interview at 8 Weeks, or at Treatment Failure, After RBX2660 Treatment Delivered by Colonoscopy | efficacy | unclassified | null | lower_is_better | false | false | 0.3 | 8 weeks after RBX2660 treatment delivered by colonoscopy | 56 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 41 | ACTUAL | Clostridium Difficile Infection Recurrence | Clostridium Difficile Infection Recurrence | DRUG | RBX2660 | Ferring Pharmaceuticals | INDUSTRY | 2023-04-21 | 2025-01-17 | 2026-04-24 | null | NONE | TREATMENT |
NCT05831189 | secondary | 5 | Number of Participants With Treatment-emergent Adverse Events up to 8 Weeks or Treatment Failure After RBX2660 Treatment | safety | count | adverse_event_incidence | lower_is_better | true | false | 0.96 | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy | 56 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 41 | ACTUAL | Clostridium Difficile Infection Recurrence | Clostridium Difficile Infection Recurrence | DRUG | RBX2660 | Ferring Pharmaceuticals | INDUSTRY | 2023-04-21 | 2025-01-17 | 2026-04-24 | null | NONE | TREATMENT |
NCT05831189 | secondary | 6 | Number of Participants With Serious Adverse Events (SAEs) | safety | count | serious_adverse_events | lower_is_better | true | false | 0.96 | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy | 56 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 41 | ACTUAL | Clostridium Difficile Infection Recurrence | Clostridium Difficile Infection Recurrence | DRUG | RBX2660 | Ferring Pharmaceuticals | INDUSTRY | 2023-04-21 | 2025-01-17 | 2026-04-24 | null | NONE | TREATMENT |
NCT05831189 | secondary | 7 | Number of Participants With Any Adverse Events of Special Interest (AESIs) | safety | count | adverse_event_incidence | lower_is_better | true | false | 0.96 | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy | 56 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 41 | ACTUAL | Clostridium Difficile Infection Recurrence | Clostridium Difficile Infection Recurrence | DRUG | RBX2660 | Ferring Pharmaceuticals | INDUSTRY | 2023-04-21 | 2025-01-17 | 2026-04-24 | null | NONE | TREATMENT |
NCT05831189 | secondary | 8 | Number of Participants With Adverse Events Leading to Death or Intensive Care Unit (ICU) Admission | safety | count | adverse_event_incidence | lower_is_better | true | false | 0.96 | Up to 8 weeks after RBX2660 treatment delivered by colonoscopy | 56 | 1 | false | false | 0.9 | PHASE3 | INTERVENTIONAL | COMPLETED | true | 41 | ACTUAL | Clostridium Difficile Infection Recurrence | Clostridium Difficile Infection Recurrence | DRUG | RBX2660 | Ferring Pharmaceuticals | INDUSTRY | 2023-04-21 | 2025-01-17 | 2026-04-24 | null | NONE | TREATMENT |
NCT05135650 | primary | 0 | Half-life of Sotrovimab (VIR-7831) Post-transplant | pharmacokinetics | pk_parameter | pk_exposure | unspecified | true | false | 1 | Up to 24 weeks | 168 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | TERMINATED | true | 20 | ACTUAL | COVID-19 Infection | COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm | OTHER; BIOLOGICAL; PROCEDURE | Questionnaire Administration; Sotrovimab; Biospecimen Collection | Fred Hutchinson Cancer Center | OTHER | 2022-01-25 | 2023-01-10 | 2025-02-13 | null | NONE | PREVENTION |
NCT05135650 | primary | 1 | Neutralizing Antibody Titers | immunogenicity | change_from_baseline | null | unspecified | false | false | 0.72 | Up to 24 weeks | 168 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | TERMINATED | true | 20 | ACTUAL | COVID-19 Infection | COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm | OTHER; BIOLOGICAL; PROCEDURE | Questionnaire Administration; Sotrovimab; Biospecimen Collection | Fred Hutchinson Cancer Center | OTHER | 2022-01-25 | 2023-01-10 | 2025-02-13 | null | NONE | PREVENTION |
NCT05135650 | secondary | 0 | Half-life of VIR-7831 in Matched vs Mismatched Donors | pharmacokinetics | pk_parameter | pk_exposure | unspecified | true | false | 1 | Up to 24 weeks | 168 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | TERMINATED | true | 20 | ACTUAL | COVID-19 Infection | COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm | OTHER; BIOLOGICAL; PROCEDURE | Questionnaire Administration; Sotrovimab; Biospecimen Collection | Fred Hutchinson Cancer Center | OTHER | 2022-01-25 | 2023-01-10 | 2025-02-13 | null | NONE | PREVENTION |
NCT05135650 | secondary | 1 | Half-life of VIR-7831 in Autologous vs Allogeneic HCT | pharmacokinetics | pk_parameter | pk_exposure | unspecified | true | false | 1 | Up to 24 weeks | 168 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | TERMINATED | true | 20 | ACTUAL | COVID-19 Infection | COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm | OTHER; BIOLOGICAL; PROCEDURE | Questionnaire Administration; Sotrovimab; Biospecimen Collection | Fred Hutchinson Cancer Center | OTHER | 2022-01-25 | 2023-01-10 | 2025-02-13 | null | NONE | PREVENTION |
NCT05135650 | secondary | 2 | VIR-7831 Exposure in Patients With Diarrhea vs no Diarrhea | pharmacokinetics | pk_parameter | pk_exposure | unspecified | true | false | 1 | Up to 24 weeks | 168 | 1 | false | false | 0.9 | PHASE1 | INTERVENTIONAL | TERMINATED | true | 20 | ACTUAL | COVID-19 Infection | COVID-19 Infection; Hematopoietic and Lymphoid Cell Neoplasm; Malignant Solid Neoplasm | OTHER; BIOLOGICAL; PROCEDURE | Questionnaire Administration; Sotrovimab; Biospecimen Collection | Fred Hutchinson Cancer Center | OTHER | 2022-01-25 | 2023-01-10 | 2025-02-13 | null | NONE | PREVENTION |
Clinical Trial Outcomes (2020+) with Normalized Endpoints
124,790 normalized endpoints across 14,170 clinical studies that started on or after 2020-01-01 and have posted results on ClinicalTrials.gov.
Snapshot: 2026-09-08. Source: ClinicalTrials.gov API v2 (U.S. National Library of Medicine).
Built with ctgov β the same normalizer, released as an
MIT-licensed package with zero dependencies. So this snapshot is not a dead artifact: you can
re-run it against the live registry, or normalize endpoints it does not cover.
The problem this solves
ClinicalTrials.gov stores trial endpoints as free prose. Straight from the API, you get this:
| raw endpoint text | raw timeframe |
|---|---|
Primary Safety: Freedom From Index Procedure Related Major Complications |
30 days |
Serum Markers (HbA1c) to Follow the Evolution of Liver Damage |
6 months |
Cmax of midazolam |
0, 0.5, 1, 1.5, 2, 3, 4, 6, 8, 12 hours post-dose |
Anxiety Rating |
Baseline |
You cannot group, filter, or compare across trials with that. Every cross-trial analysis starts by rebuilding the same normalization layer from scratch.
This dataset ships that layer:
| endpoint_domain | endpoint_measure_type | endpoint_canonical | horizon_days | direction |
|---|---|---|---|---|
| safety | proportion | β | 30.0 | higher_is_better |
| biomarker_laboratory | change_from_baseline | hba1c_change | 182.64 | lower_is_better |
| pharmacokinetics | pk_parameter | pk_exposure | 0.5 | unspecified |
| patient_reported | score_scale | anxiety_score | 0.0 | lower_is_better |
The raw text is preserved on every row, so any normalization can be audited rather than trusted.
Quick start
from datasets import load_dataset
ds = load_dataset("GooseWithStories/clinical-trial-outcomes-2020plus", "endpoints", split="train")
# High-precision Phase 3 survival endpoints in industry trials
rows = ds.filter(lambda r:
r["endpoint_canonical"] == "overall_survival"
and "PHASE3" in (r["phase"] or "")
and r["sponsor_class"] == "INDUSTRY"
and r["normalization_confidence"] >= 0.7
)
What's inside
| config | rows | description |
|---|---|---|
endpoints (default) |
124,790 | One row per (study, endpoint), study attributes denormalized on. |
studies |
14,170 | One row per study, with endpoint counts. |
Normalized fields
endpoint_domainβsafety,efficacy,patient_reported,pharmacokinetics,biomarker_laboratory,clinical_assessment,behavioral_functional,healthcare_utilization,immunogenicity,feasibility_implementation,diagnostic_accuracy,unclassifiedendpoint_measure_typeβchange_from_baseline,proportion,count,score_scale,time_to_event,pk_parameter,concentration,continuous_value,diagnostic_accuracy,unclassifiedendpoint_canonicalβ one of 38 standard concepts where they apply:overall_survival,progression_free_survival,invasive_disease_free_survival,objective_response_rate,pathologic_complete_response,dose_limiting_toxicity,adverse_event_incidence,serious_adverse_events,hba1c_change,cgm_time_in_range,clinical_status_ordinal_scale,quality_of_life,seroconversion,pk_exposure, and moreendpoint_directionβhigher_is_better/lower_is_better/ambiguous/unspecifiedhorizon_daysβ free-text timeframe parsed to a number (hours Γ· 24, weeks Γ 7, months Γ 30.44, years Γ 365.25, cycles Γ 21)normalization_confidenceβ 0β1 per row. Recommended filter:>= 0.7
Plus full study context on every row: phase, study_type, overall_status, enrollment_count,
condition_primary, conditions_all, intervention_types, intervention_names, lead_sponsor,
sponsor_class, allocation, masking, primary_purpose, and dates.
Coverage β stated honestly
Unclassified rates are published as prominently as success rates. An accurate coverage number is more useful than a confident label on every row.
| metric | value |
|---|---|
| Endpoints with an assigned clinical domain | 71.9% |
| Endpoints with an assigned measure type | 90.2% |
| Endpoints with a parsed numeric time horizon | 61.3% |
| Endpoints mapped to a canonical concept | 35.0% |
| domain | n | domain | n | |
|---|---|---|---|---|
| unclassified | 35,026 | clinical_assessment | 9,199 | |
| patient_reported | 16,146 | biomarker_laboratory | 8,973 | |
| safety | 14,764 | healthcare_utilization | 5,435 | |
| efficacy | 13,715 | behavioral_functional | 4,985 | |
| pharmacokinetics | 10,439 | immunogenicity | 3,688 | |
| feasibility_implementation | 2,084 | |||
| diagnostic_accuracy | 336 |
On the 28.1% unclassified: a genuine long tail of disease-specific measures ("Swollen Joint
Count", "Bowel Filling Properties: Distension/Distal Ileum"). Rather than force these into an
ill-fitting bucket, they are labelled unclassified with raw text retained.
endpoint_domain_inferred = true marks rows whose domain was set by a recognised canonical
concept. The concept outranks loose keywords, so this is the stronger signal β do not filter
these rows out. endpoint_measure_inferred = true marks rows whose measure type was taken from
the concept because the text named none.
Method
- Fetch β ClinicalTrials.gov API v2, filtered to
AREA[StartDate]RANGE[2020-01-01,MAX]andAREA[HasResults]true, rate-limited well under NLM's 20 req/s ceiling. - Normalize β a deterministic, ordered rule cascade (specific β general, first match wins)
assigns domain, measure type, canonical concept and direction; a unit-aware parser converts
free-text timeframes to
horizon_days. - Emit β CSV + JSONL with a machine-readable coverage report.
No model inference in the pipeline. The normalizer is fully deterministic, so it is reproducible, auditable, and free to re-run against the live registry.
The taxonomy was built empirically: an initial version left 50.1% of endpoints without a domain, so
categories were derived by inspecting actual failures rather than assumed up front. That surfaced
whole missing classes (laboratory/biomarker, healthcare utilization, feasibility/implementation) and
two outright bugs β death\b never matched "Deaths", and number of (participants) missed
"Number of Episodes". First release: 32.6% unclassified; 28.1% after the ctgov 0.1.1 fixes (see
Corrections).
Rebuild or extend it yourself
The normalizer is on PyPI and its source is in src/ in this repo, so nothing here is a black box.
pip install ctgov
from ctgov import endpoints
# Same columns as this dataset, for any query - including trials with no posted results,
# which this snapshot excludes.
rows = endpoints("AREA[Condition]melanoma", max_studies=500)
ctgov also pages past the API's 1,000-study response cap, which is how this dataset's 14,170
studies were pulled. Source and changelog: github.com/GooseWithTheStories/ctgov.
Corrections
v1.2 (2026-09-10) β normalizer ctgov 0.1.1.
Every change was checked row by row against v1.1, rebuilt from the committed pipeline (it reproduces v1.1's published coverage exactly). 9,309 rows (7.5%) changed domain and 12,082 (9.7%) changed concept. Coverage: domain 67.4% β 71.9%, measure type 86.6% β 90.2%, concept 27.6% β 35.0%.
- A definition no longer overrides the endpoint's name. Concepts are read from the endpoint
name first and from the description only as a fallback. 275 rows v1.1 filed as
hospitalizationare adverse-event endpoints whose definitions mention hospitalization; 421 EQ-5D and EORTC QLQ-C30 rows move from depression / cognitive / pain toquality_of_life; serious-AE endpoints areserious_adverse_eventsunless they also count any AE. - Dose-limiting toxicity, the standard Phase 1 primary endpoint, is now recognised
(
dose_limiting_toxicity, domainsafety): 541 rows, 28 of which had carriedhospitalizationbecause DLT definitions say "requiring hospitalization". - Ordinal clinical-status scales (WHO / NIAID, mostly COVID-19 trials): 662 rows are now
clinical_status_ordinal_scale. Their category lists ("Hospitalized, on oxygen ... Not hospitalized") had made them look like hospitalization endpoints. - Word stems that could never match (toxicity, feasibility, plurals) now do: unclassified domain 40,659 β 35,026; feasibility 1,056 β 2,084; pharmacokinetics 8,891 β 10,439.
- Precision:
diagnostic_accuracyneeds diagnostic context, so insulin sensitivity, contrast sensitivity and high-sensitivity CRP no longer count; "hospitalized" counts only when it names the outcome ("participants who were hospitalized"), not the population ("in hospitalized adults"). - Terse rows no longer fall below the confidence bar. A bare "HbA1c" or "Overall Response
Rate" scored 0.64 because the text named no measure; the measure type is now taken from the
concept and flagged in the new
endpoint_measure_inferredcolumn (3,118 rows). Recovered above 0.7: objective response rate 192, complete response 113, pCR 33, HbA1c 100, blood pressure 350, PFS 64. - New concepts:
duration_of_response828,clinical_status_ordinal_scale662,cgm_glycemic_metric592,dose_limiting_toxicity541,disease_control_rate341,fasting_glucose195,cgm_time_in_range143,clinical_benefit_rate114,pathologic_complete_response90 (distinct from clinicalcomplete_response; case-sensitive, so COVID-19 "PCR" does not match),time_to_next_treatment72,urine_albumin_creatinine_ratio71,recurrence_free_survival54,ki67_response44, and the adjuvant breast-cancer family (distant RFS 18, locoregional recurrence 5, iDFS 4, IBCFS 1). endpoint_domain_inferredmarks the stronger signal; earlier documentation said the opposite and advised filtering those rows out. Do not.
v1.1 (2026-09-09) β survival endpoint reclassification. An earlier build of this dataset
misclassified survival endpoints. Because Overall Survival is defined as "time from
randomization until death", the word "death" caused the classifier to assign safety rather
than efficacy. Affected:
overall_survival: 827 of 1,116 rows (74%) weresafety; now all 1,116 areefficacyprogression_free_survival: 1,046 of 1,418 rows (74%) weresafety; now all 1,418 areefficacy
Fixed by making a recognised canonical concept outrank a loose keyword match. Two further fixes
landed in the same build: "Glycosylated Haemoglobin" now maps to hba1c_change (only the
glycated spelling was matched before), and shared-unit sampling schedules such as
"0, 0.5, 1 ... 12 hours post-dose" are now counted as ten timepoints rather than one β
18,820 endpoints (24.6% of parsed schedules) are now correctly flagged is_longitudinal.
In total roughly 5,200 rows (4.2%) changed domain. If you pulled an earlier copy, re-download.
Limitations
- Only studies with posted results are included. This biases toward completed, larger and industry-sponsored trials; it is not a representative sample of all registered trials.
horizon_daysis the maximum timepoint mentioned, not a schedule. Dense PK sampling strings gettimepoint_count > 1andtimeframe_confidence = 0.65to signal this.- Direction is inferred from wording;
ambiguous/unspecifiedwhere wording doesn't settle it. - Endpoint results (measured values from the registry's results section) are not in this release β this covers endpoint definitions and study metadata.
Licence and attribution
Source data is in the public domain (U.S. Government work). This derived dataset adds only a normalization layer and is released CC0-1.0.
This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product.
The NLM name and logo are not used to endorse this dataset.
Citation
@misc{clinical_trial_outcomes_2020plus,
title = {Clinical Trial Outcomes (2020+) with Normalized Endpoints},
year = {2026},
note = {Derived from ClinicalTrials.gov API v2, U.S. National Library of Medicine.
Snapshot 2026-09-08.},
url = {https://huggingface.co/datasets/GooseWithStories/clinical-trial-outcomes-2020plus}
}
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