ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT03256799
Conditions: Cystic Fibrosis
Sponsor: University of Alabama at Birmingham
Start date: 2017-03-17; Completion date: 2018-02-16
Enrollment: 1 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to explore the combination of Ataluren and ivacaftor as a treatment for patients with a specific cystic fibrosis mutation

Detailed description:
In about 10% of patients with CF, the defect in the gene is known as a stop mutation. This mutation truncates the cystic fibrosis transductive regulator (CFTR) protein production by introducing a premature stop in the messenger RNA (mRNA), this type of mutation is known as a stop mutation. Ataluren is a novel, oral drug that promotes this gene to work effectively and readthrough that premature "stop sign". It is hypothesized that ivacaftor may increase the efficacy of Ataluren by activating a specific protein that may not be functioning properly.

Arms: arm 1: None
Interventions: intervention 1: Ivacaftor/Ataluren
Intervention descriptions: intervention 1: Both drugs were given in combination for 48 week study period

Protocol documents:
Prot_SAP_ICF_000.pdf:
Clinical trial NCT01986114
Conditions: Bipolar I Disorder
Sponsor: Sumitomo Pharma Co., Ltd.
Start date: 2014-01-29; Completion date: 2018-02-17
Enrollment: 495 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study evaluates the long-term efficacy and safety of SM-13496 in patients with bipolar I disorder.

Detailed description:
The study objective is to evaluate the long-term efficacy and safety of SM-13496 (20-120 mg/day) in patients with bipolar I disorder.

Arms: arm 1: once daily orally SM-13496 20-120 mg flexibly dosed
Interventions: intervention 1: SM-13496
Intervention descriptions: intervention 1: None

Protocol documents:
Prot_000.pdf: 































































































































































SAP_001.pdf:
Clinical trial NCT01874054
Conditions: Hodgkin Disease
Keywords: Antibody-Drug Conjugate Antibodies, Monoclonal Hodgkin Disease Hematologic Diseases Drug Therapy Immunotherapy Antigens, CD30 Lymphoma monomethylauristatin E
Sponsor: Seagen Inc.
Start date: 2013-06-01; Completion date: 2018-02-20
Enrollment: 55 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess safety and efficacy of brentuximab vedotin in combination with bendamustine in patients with relapsed or refractory Hodgkin lymphoma. It is an open-label, 2-stage study designed to determine the recommended dose level of bendamustine in combination with brentuximab vedotin. The study will assess the safety profile of the combination treatment and determine what proportion of patients achieve a complete remission.

Detailed description:

Arms: arm 1: Brentuximab vedotin 1.8 mg/kg every 3 weeks for up to 16 cycles by IV infusion and bendamustine 90 mg/m2 on Days 1 and 2 every 3 weeks by IV infusion for up to 6 cycles
Interventions: intervention 1: brentuximab vedotin intervention 2: bendamustine
Intervention descriptions: intervention 1: 1.8 mg/kg every 3 weeks by intravenous (IV) infusion intervention 2: 90 mg/m2 on Days 1 and 2 of 3-week cycles

Protocol documents:
Clinical trial NCT01565928
Conditions: Prostate Cancer
Keywords: Prostate cancer docetaxel MDV3100 enzalutamide Xtandi
Sponsor: Pfizer
Start date: 2012-01-24; Completion date: 2018-02-26
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the safety of MDV3100 given in combination with Docetaxel in men with advanced prostate cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: MDV3100
Intervention descriptions: intervention 1: 4 x 40 mg capsules, orally, once per day

Protocol documents:
Clinical trial NCT03402893
Conditions: Acne Vulgaris Post Inflammatory Hyperpigmentation
Sponsor: Derm Research, PLLC
Start date: 2017-07-28; Completion date: 2018-02-28
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-center, open label pilot study. The study is comprised of 5 study visits; Screening, Baseline, and Weeks 4, 8, and 16. All subjects will receive Onexton at Baseline and be instructed to apply the gel once daily to the face. The investigators will evaluate Investigator Global Assessment of acne (IGA), total lesion count, inflammatory lesion count, non-inflammatory lesion count, Investigator Global Assessment of Post-Inflammatory Hyperpigmentation and distribution of Post-Inflammatory Hyperpigmentation, adverse events and concomitant medications.

Detailed description:

Arms: arm 1: Onexton gel will be supplied to all subjects and applied once daily to the face
Interventions: intervention 1: ONEXTON Topical Gel
Intervention descriptions: intervention 1: Onexton gel applied once daily to face

Protocol documents:
Prot_SAP_001.pdf: 

































ICF_000.pdf:
Clinical trial NCT01215344
Conditions: Multiple Myeloma
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2010-11-01; Completion date: 2018-03-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to study the MRD status after VELCADE based induction therapy (VELCADE, lenalidomide, dexamethasone or VELCADE, liposomal doxorubicin, dexamethasone) in patients with previously untreated multiple myeloma and study the impact of HDC and ASCT on MRD status post-transplant. Our hypothesis is that MRD-status will continue to increase significantly at 3 months post-transplant and will validate that HDC and ASCT needs to be performed even when patients have achieved major response after induction therapy with novel agents.

Detailed description:

Arms: arm 1: VELCADE, Lenalidomide, Dexamethasone arm 2: VELCADE, liposomal doxorubicin, dexamethasone
Interventions: intervention 1: VELCADE intervention 2: Lenalidomide intervention 3: Dexamethasone intervention 4: DVT prophylaxis intervention 5: Bisphosphonates intervention 6: Liposomal doxorubicin intervention 7: Dexamethasone
Intervention descriptions: intervention 1: 1.3 mg/m2 by IV on days 1, 4, 8, 11 of each cycle intervention 2: 25 mg by mouth on days 1-4 of each cycle intervention 3: 20 mg the day before and the day after receiving VELCADE intervention 4: At least one asprin 81 mg per day. Other option per physician's choice intervention 5: Zoledronic acid by IB or pamidronate by IV can be used as per standard of care. intervention 6: 30 mg/m2 on day 4 of each cycle intervention 7: 40 mg by mouth on days 1-4, 8-11, and 15-18 of cycle 1 and days 1-4 on cycle 2-4

Protocol documents:
Clinical trial NCT02328547
Conditions: Irritable Bowel Syndrome
Keywords: fecal microbiota transplantation diarrhea-predominant
Sponsor: Montefiore Medical Center
Start date: 2015-05-01; Completion date: 2018-03-01
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objectives of this study are (1) to determine the efficacy of fecal microbiota transplantation (FMT), given as oral capsules, compared with placebo for the treatment of refractory diarrhea-predominant irritable bowel syndrome (IBS-D); (2) determine the impact of FMT on the intestinal microbiome of patients with IBS-D; and (3) assess the safety, feasibility, and tolerability of FMT for patients with IBS-D.

Detailed description:
This is a multicenter study including Montefiore Medical Center, Concorde Medical Group PLLC and the Medical Research Center of Connecticut/Yale-New Haven Hospital Langone Medical Center. Patients with IBS-D will be recruited from outpatient gastroenterology clinics at these institutions and referrals from the medical community.

FMT capsules and placebo capsules, provided by OpenBiome, Medford, MA, will be used for this study. Patients will be randomized to undergo FMT using fecal capsules (experimental group) or placebo capsules (control group) via a computer-generated program. All patients will cross-over into the alternate arm of the study at 12 weeks. Therefore, all patients enrolled will receive the experimental drug during the course of the study. Each patient will be enrolled in the study for a total of 6 months.

Intestinal microbiome analyses using DNA sequencing and non-cultivation-based approaches (16S DNA technology) will be performed in all patients in the experimental and control groups to assess stability of the microbiome over time.

Arms: arm 1: Intervention: Fecal microbiota transplantation capsules containing extensively screened donor stool, prepared by OpenBiome, Medford, MA. 25 FMT capsules will be take on three consecutive days. arm 2: Intervention: Placebo capsules that do not contain donor stool or any active drug, prepared by OpenBiome, Medford, MA. 25 placebo capsules will be taken on three consecutive days.
Interventions: intervention 1: Fecal microbiota transplantation capsules intervention 2: Placebo capsules
Intervention descriptions: intervention 1: Fecal microbiota transplantation capsules contain extensively screened donor stool and are prepared by OpenBiome, Medford, MA. intervention 2: Placebo capsules prepared by OpenBiome, Medford, MA

Protocol documents:
Prot_SAP_000.pdf: 
Official Study Title: 
NCT Number: 
Document Description: 
Document Date: 
+#3H@•#il§i IRB NUMBER: 2014-3941
-.!-:,':':,.-..- IRB APPROVAL DATE: 04/24/2015 
Montefiore Medical Center 
Multicenter, Randomized, Double-blinded, Placebo-controlled Trial 
of Fecal Microbiota Transplantation (FMT) for Diarrhea-
Predominant Irritable Bowel Svndrome (IBS-D) 
NCT02328547 
Final Study Protocol with Statistical Analysis Plan (SAP) 
24 April 2015
Clinical trial NCT00398567
Conditions: Advanced Breast Cancer
Keywords: HKI-272 neratinib trastuzumab breast cancer Nerlynx PB-272 HER2
Sponsor: Puma Biotechnology, Inc.
Start date: 2007-04-04; Completion date: 2018-03-02
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of HKI-272 (neratinib) in combination with trastuzumab in patients with advanced breast cancer.

Detailed description:
Open label phase 1/2 study of ascending multiple oral doses of HKI-272 in combination with IV trastuzumab in subjects with advanced human epidermal growth factor receptor 2 positive (HER2+) breast cancer. Three to six subjects will be enrolled in each dose group. Adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 21. When the maximum tolerated dose (MTD) of HKI-272 plus trastuzumab is determined, an additional 30 subjects will be enrolled at that dose level, and followed for progression free survival for approximately 1 year.

Arms: arm 1: All subjects receiving HKI-272 dose level 1 in combination with trastuzumab arm 2: All subjects receiving HKI-272 dose level 2 in combination with trastuzumab arm 3: All subjects receiving HKI-272 in combination with trastuzumab
Interventions: intervention 1: HKI-272 intervention 2: trastuzumab
Intervention descriptions: intervention 1: HKI-272 by mouth intervention 2: trastuzumab 4 mg/kg IV as a loading dose followed by trastuzumab 2 mg/kg weekly thereafter

Protocol documents:
Clinical trial NCT01685983
Conditions: Prostate Cancer
Keywords: Prostate Cancer Metastatic-castration resistant prostate cancer Prostate specific antigen Abiraterone acetate JNJ-212082 Abiraterone Prednisolone Androgen Deprivation Docetaxel-based chemotherapy
Sponsor: Janssen Research & Development, LLC
Start date: 2011-08-30; Completion date: 2018-03-06
Enrollment: 82 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and efficacy in Korea or Taiwan of oral abiraterone acetate and oral prednisolone in men with metastatic-castration resistant prostate cancer (mCRPC) and with disease progression following treatment with a docetaxel-containing chemotherapy.

Detailed description:
This is an open-label (all people know the identity of the intervention), multicenter, single arm (only one treatment group) study to evaluate the efficacy and safety of abiraterone acetate in patients with mCRPC. The study will be divided into screening phase (up to 28 days before enrollment), treatment phase including treatment cycles (each cycle of treatment will be 28 days), and follow-up phase. Approximately 80 patients will be enrolled into this study. Safety evaluations for adverse events, clinical laboratory tests, electrocardiogram and vital signs as well as pharmacokinetic (what the body does to drug) assessments will be conducted in this study. Patients will continue to receive abiraterone acetate plus prednisolone until disease progression or occurrence of unacceptable toxicity.

Arms: arm 1: None
Interventions: intervention 1: Abiraterone acetate intervention 2: Prednisolone
Intervention descriptions: intervention 1: Type=exact number, unit=mg, number=250, form=tablet, route=oral. Patients will receive 4 tablets of abiraterone acetate at least 1 hour before a meal or 2 hours after a meal any time up to 10 pm every day. intervention 2: Type=exact number, unit=mg, number=5, form=tablet, route=oral. Patients will receive 1 tablet of prednisolone twice daily.

Protocol documents:
Clinical trial NCT01642407
Conditions: Pulmonary Arterial Hypertension Hypertension, Pulmonary
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2012-08-24; Completion date: 2018-03-12
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Pulmonary arterial hypertension (PAH) is a rare, progressive, and life-threatening disease. In many patients, the course of PAH is a steady deterioration and reduced life expectancy.

Sildenafil was approved by the European Commission for the treatment of PAH in pediatric patients in May 2011, making it the first agent to be approved for the treatment of children with PAH. The approval was based on the largest placebo-controlled study to be conducted in this population. The recommended dose in pediatric patients aged 1 year to 17 years old is 10 mg TID in patients ≤ 20 kg and 20 mg TID for patients \> 20 kg. Higher doses are not recommended in pediatrics patients.

This study is an open-label, multi-center study to investigate safety, efficacy and pharmacokinetics of sildenafil citrate in Japanese pediatric patients with PAH.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sildenafil
Intervention descriptions: intervention 1: Body weight \> 20 kg: 20 mg TID (60 mg/day) Body weight ≤ 20 kg: 10 mg TID (30 mg/day) Treatment duration: 16 weeks in Part 1, until until sildenafil obtained marketing approval in Part 2

Protocol documents:
Clinical trial NCT01599325
Conditions: Myelodysplastic Syndrome (MDS)
Sponsor: Celgene
Start date: 2012-07-24; Completion date: 2018-03-13
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine whether azacitidine is safe and effective in the treatment of Chinese patients with higher risk Myelodysplastic Syndromes (MDS).

Detailed description:

Arms: arm 1: Azacitidine 75 mg/m\^2/day subcutaneously (SC) for 7 days every 28 days until disease progression (DP), adverse events (AE), withdrawal of consent from further treatment, withdrawal of consent, death, lost to follow-up, or protocol violation.
Interventions: intervention 1: Azacitidine
Intervention descriptions: intervention 1: Subcutaneous administration of azacitidine 75 mg/m\^2/day for 7 days every 28 days optimally for at least 6 cycles until disease progression, unacceptable toxicity, or treatment discontinuation for any other reason

Protocol documents:
Clinical trial NCT03148236
Conditions: Atrial Fibrillation Ablation
Sponsor: Virginia Commonwealth University
Start date: 2017-09-18; Completion date: 2018-03-13
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Single-center, double-blinded, randomized, controlled safety and feasibility pilot study of high dose IV ascorbic acid (200mg/kg) over 24 hours, divided into four doses and administered every six hours with a 30 minute IV infusion time per dose, compared to matched placebo infusion

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Vitamin C intervention 2: Placebo
Intervention descriptions: intervention 1: 200mg/kg/day split into 4 doses infused every six hours over 30 minutes in 50ml D5W intervention 2: 50mL infused over 30 minutes

Protocol documents:
Prot_000.pdf:
Clinical trial NCT00263588
Conditions: Neoplasms, Breast
Keywords: breast cancer brain metastases ErbB2 positive HER2 positive neoplasms cancer lapatinib LAP016A2202 LAP016A CLAP016A2202 GW572016
Sponsor: Novartis Pharmaceuticals
Start date: 2005-12-02; Completion date: 2018-03-15
Enrollment: 242 participants; Allocation: NON_RANDOMIZED; Intervention model: 

Brief summary:
Determine how safe and effective lapatinib is when used to treat patients with ErbB2 overexpressing breast cancer that has spread to the brain and is still progressing there even after radiation treatment using WBRT (whole brain radiotherapy) or SRS (stereotactic radiosurgery) to the brain. Lapatinib is an oral drug that will be taken every day. Tests for safety and efficacy will be performed every 4 weeks or 8 weeks (depending on the test) during the course of the study.

Detailed description:

Arms: arm 1: 750 mg lapatinib administered orally twice daily
Interventions: intervention 1: lapatinib
Intervention descriptions: intervention 1: tyrosine kinase inhibitor

Protocol documents:
Clinical trial NCT01605396
Conditions: Breast Neoplasms
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-07-04; Completion date: 2018-03-15
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy of the triplet of ridaforolimus, dalotuzumab and exemestane compared to the combination of ridaforolimus and exemestane in post-menopausal participants with breast cancer. The primary hypothesis of the study is that the triplet of ridaforolimus, dalotuzumab and exemestane will improve progression free survival (PFS) compared to ridaforolimus and exemestane.

Detailed description:

Arms: arm 1: Participants receive ridaforolimus 10 mg orally (PO) every 5 days (QD x 5) plus dalotuzumab 10 mg/kg intravenously (IV) every week (QW) plus exemestane 25 mg PO every day (QD) in 28-day cycles until documented disease progression or unacceptable toxicity. arm 2: Participants receive ridaforolimus 30 mg PO QD x 5 plus exemestane 25 mg PO QD treatment in 28-day cycles until documented disease progression or unacceptable toxicity.
Interventions: intervention 1: Ridaforolimus intervention 2: Dalotuzumab intervention 3: Exemestane
Intervention descriptions: intervention 1: Ridaforolimus 10 mg tablet, administered PO at a dose of 10 mg (triplet) or 30 mg (doublet) depending upon randomization, on Days 1-5, 8-12, 15-19, \& 22-26 of 28-day cycle. intervention 2: Dalotuzumab administered 10 mg/kg IV weekly on Days 1, 8, 15, and 22 of 28-day cycle. intervention 3: Exemestane 25 mg tablet administered PO QD.

Protocol documents:
Clinical trial NCT02187861
Conditions: Follicular Lymphoma
Sponsor: Hoffmann-La Roche
Start date: 2014-12-01; Completion date: 2018-03-16
Enrollment: 163 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This open-label, international, multicenter study will investigate the safety and efficacy of venetoclax (GDC-0199) in combination with bendamustine plus rituximab (venetoclax + BR) compared with BR alone in participants with relapsed and refractory fNHL, comparing two chemotherapy-containing regimens (Chemotherapy-Containing Cohort). In addition, an exploratory analysis of the safety and efficacy of venetoclax in combination with rituximab (venetoclax + rituximab), a chemotherapy-free regimen, will be performed (Chemotherapy-Free Cohort). Assignment to the Chemotherapy-Containing or Chemotherapy-Free Cohort will be decided at the discretion of the Investigator, unless one of the cohorts is not open to enrollment; in which case, participants may be enrolled only to the open cohort. The first 6 participants enrolled in the Chemotherapy-Containing Cohort (or more if required) will comprise the Safety Run-In group for Treatment Arm B, dosing venetoclax at 600 milligrams (mg) in combination with BR. Once a dose has been chosen from the Safety Run-In Period, randomization to the two treatment arms of the Chemotherapy-Containing Cohort (Arms B and C) will begin.

Detailed description:

Arms: arm 1: Participants will receive venetoclax no more than 600 milligrams (mg) orally once daily continuously along with rituximab 375 milligrams per square meter (mg/m\^2) intravenous (IV) infusion on Day 1 of 28-day cycle and bendamustine 90 mg/m\^2 IV infusion on Days 1 and 2 of the 28-day cycle. Safety run-in will continue until first 9 participants complete the safety observation window of 28 days. Participants will continue receiving the same treatment as decided for Arm B. arm 2: Participants will receive venetoclax 800 mg orally once daily for 1 year along with rituximab 375 mg/m\^2 IV infusion on Days 1, 8, 15, 22 of Cycle 1 and Day 1 of Cycles 4, 6, 8, 10, and 12. Each cycle will be of 28 days. arm 3: Participants will receive venetoclax at doses decided from safety run-in orally once daily continuously for 1 year along with rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles. arm 4: Participants will receive rituximab 375 mg/m\^2 IV infusion on Day 1 of each 28-day cycle and bendamustine 90 mg/m\^2 IV infusion on Days 1 and 2 of each 28-day cycle, for 6 cycles.
Interventions: intervention 1: Venetoclax intervention 2: Bendamustine intervention 3: Rituximab
Intervention descriptions: intervention 1: Venetoclax will be administered as per the schedule specified under arm description. intervention 2: Bendamustine will be administered as per the schedule specified under arm description. intervention 3: Rituximab will be administered as per the schedule specified under arm description.

Protocol documents: