_id stringlengths 10 10 | nctid stringlengths 11 11 | prompt stringlengths 4.54k 15.9k | answer stringlengths 1 7 |
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trial_0003 | NCT02477826 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: An Investigational Immuno-therapy Trial of Nivolumab, or Nivolumab Plus Ipilimumab, or Nivolumab Plus Platinum-doublet Chemotherapy, Compared to Platinum Doublet Chemotherapy in... | A |
trial_0000 | NCT04208529 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Long-term Follow-up Study in Participants Who Received CTX001
Brief Summary: This is a multi-site, open- label rollover study to evaluate the long-term safety and efficacy of... | J |
trial_0006 | NCT02166463 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Brentuximab Vedotin and Combination Chemotherapy in Treating Children and Young Adults With Stage IIB, Stage IIIB, IVA, or IVB Hodgkin Lymphoma
Brief Summary: This phase III tr... | B |
trial_0013 | NCT03043872 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Durvalumab ± Tremelimumab in Combination With Platinum Based Chemotherapy in Untreated Extensive-Stage Small Cell Lung Cancer (CASPIAN)
Brief Summary: This is a phase III, rand... | I |
trial_0023 | NCT02362594 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Study of Pembrolizumab (MK-3475) Versus Placebo After Complete Resection of High-Risk Stage III Melanoma (MK-3475-054/1325-MG/KEYNOTE-054)
Brief Summary: This study will assess... | I |
trial_0028 | NCT02767804 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: eXalt3: Study Comparing X-396 (Ensartinib) to Crizotinib in ALK Positive Non-Small Cell Lung Cancer (NSCLC) Patients
Brief Summary: The primary purpose of this study is to eval... | H |
trial_0030 | NCT04102189 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Research Study on How Well Semaglutide Works in Adolescents With Overweight or Obesity
Brief Summary: This study will look at the change in teenagers' body weight from the st... | A |
trial_0031 | NCT03875235 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Durvalumab or Placebo in Combination With Gemcitabine/Cisplatin in Patients With 1st Line Advanced Biliary Tract Cancer (TOPAZ-1)
Brief Summary: Durvalumab or Placebo in Combin... | A |
trial_0046 | NCT03690388 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Study of Cabozantinib Compared With Placebo in Subjects With Radioiodine-refractory Differentiated Thyroid Cancer Who Have Progressed After Prior Vascular Endothelial Growth F... | B |
trial_0044 | NCT03568318 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Study to Evaluate Upadacitinib in Combination With Topical Corticosteroids in Adolescent and Adult Participants With Moderate to Severe Atopic Dermatitis
Brief Summary: The o... | H |
trial_0050 | NCT03615326 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Pembrolizumab/Placebo Plus Trastuzumab Plus Chemotherapy in Human Epidermal Growth Factor Receptor 2 Positive (HER2+) Advanced Gastric or Gastroesophageal Junction (GEJ) Adenoca... | J |
trial_0062 | NCT04209634 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Open-Label Efficacy and Safety Study of Pozelimab in Patients With CD55-Deficient Protein-Losing Enteropathy (CHAPLE Disease)
Brief Summary: The primary objective of the study ... | I |
trial_0067 | NCT04209855 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Study of Mirvetuximab Soravtansine vs. Investigator's Choice (IC) of Chemotherapy in Platinum-Resistant, Advanced High-Grade Epithelial Ovarian, Primary Peritoneal, or Fallopi... | J |
trial_0068 | NCT04656652 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Study of DS-1062a Versus Docetaxel in Previously Treated Advanced or Metastatic Non-small Cell Lung Cancer With or Without Actionable Genomic Alterations (TROPION-LUNG01)
Brief... | I |
trial_0076 | NCT03345823 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Maintenance and Long-Term Extension Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Crohn's Disease Who Completed the Studies M14-431 or M14-43... | I |
trial_0081 | NCT03995108 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Efficacy and Safety Study of Mavorixafor in Participants With Warts, Hypogammaglobulinemia, Infections, and Myelokathexis (WHIM) Syndrome
Brief Summary: This study has a double... | G |
trial_0084 | NCT05285644 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Study Evaluating the Safety and Efficacy of AR-15512
Brief Summary: This will be a Phase 3, multicenter, vehicle-controlled, double-masked, randomized study conducted at approx... | G |
trial_0095 | NCT02016924 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Study of Cobicistat-Boosted Atazanavir (ATV/co), Cobicistat-Boosted Darunavir (DRV/co) and Emtricitabine/Tenofovir Alafenamide (F/TAF) in Children With HIV
Brief Summary: The g... | A |
trial_0101 | NCT02107703 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Study of Abemaciclib (LY2835219) Combined With Fulvestrant in Women With Hormone Receptor Positive HER2 Negative Breast Cancer
Brief Summary: The main purpose of this study i... | B, G |
trial_0097 | NCT02231749 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Nivolumab Combined With Ipilimumab Versus Sunitinib in Previously Untreated Advanced or Metastatic Renal Cell Carcinoma (CheckMate 214)
Brief Summary: The purpose of this study... | I |
trial_0108 | NCT03164564 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Evaluating the Safety and Efficacy of Long-Acting Injectable Cabotegravir Compared to Daily Oral TDF/FTC for Pre-Exposure Prophylaxis in HIV-Uninfected Women
Brief Summary: Thi... | A |
trial_0113 | NCT03504397 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Study to Compare Zolbetuximab (IMAB362) and Chemotherapy With Placebo and Chemotherapy in Adults With Gastric Cancer.
Brief Summary: Zolbetuximab is being studied in people w... | A, F |
trial_0118 | NCT03896581 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Study to Evaluate the Efficacy and Safety of Bimekizumab in the Treatment of Subjects With Active Psoriatic Arthritis
Brief Summary: This is a study to demonstrate the clinic... | B |
trial_0122 | NCT02407236 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
Brief Summary... | F, H |
trial_0129 | NCT03131648 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Tralokinumab Monotherapy for Moderate to Severe Atopic Dermatitis - ECZTRA 1 (ECZema TRAlokinumab Trial no. 1)
Brief Summary: Primary objective:
To evaluate the efficacy of tr... | F, I |
trial_0132 | NCT01631214 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Study to Determine the Efficacy and Safety of Romosozumab in the Treatment of Postmenopausal Women With Osteoporosis
Brief Summary: The purpose of this study is to determine if... | F, J |
trial_0141 | NCT04949399 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Study To Assess the Safety and Effects of OnabotulinumtoxinA (BOTOX) Intramuscular Injection in Adult Participants With Moderate to Severe Platysma Prominence
Brief Summary: ... | D, E, G |
trial_0145 | NCT03901339 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Study of Sacituzumab Govitecan-hziy Versus Treatment of Physician's Choice in Participants With HR+/HER2- Metastatic Breast Cancer
Brief Summary: The primary objective of this ... | F, I |
trial_0153 | NCT03836287 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
Brief Summary: Hyperhidrosis is a disorder of abnormal excessive swea... | F, H, J |
trial_0158 | NCT00383240 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)
Brief Summary: This is a randomized, ... | D, G, I |
trial_0164 | NCT03410992 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Study With a Initial Treatment Period Followed by a Randomized-withdrawal Period to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe C... | B, E |
trial_0172 | NCT03443869 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Letermovir Versus Valganciclovir to Prevent Human Cytomegalovirus Disease in Kidney Transplant Recipients (MK-8228-002)
Brief Summary: The primary objective of this study is to... | H |
trial_0178 | NCT04372186 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: A Study to Evaluate the Efficacy and Safety of Tocilizumab in Hospitalized Participants With COVID-19 Pneumonia
Brief Summary: This study (EMPACTA) will a) evaluate the efficac... | B |
trial_0183 | NCT01763827 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Monoclonal Antibody Against PCSK9 to Reduce Elevated LDL-C in Subjects Currently Not Receiving Drug Therapy for Easing Lipid Levels-2
Brief Summary: The primary objective was t... | B, G |
trial_0188 | NCT04380142 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Study Comparing Continuous Subcutaneous Infusion Of ABBV-951 With Oral Carbidopa/Levodopa Tablets For Treatment Of Motor Fluctuations In Adult Participants With Advanced Parkins... | E |
trial_0194 | NCT03417687 | Based on the following clinical trial information, identify all significant design deficiencies that could affect regulatory approval:
Title: Hyperpolarized Xenon MRI for Assessment of Pulmonary Function in Lung Resection
Brief Summary: This study compares the equivalence of hyperpolarized 129Xe MRI as compared to 13... | E, I |
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