ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00622700
Conditions: Multiple Sclerosis
Keywords: MS Clinically Isolated Syndrome CIS CDMS relapses
Sponsor: Sanofi
Start date: 2008-02-01; Completion date: 2016-02-01
Enrollment: 618 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to demonstrate the effect of teriflunomide (HMR1726) (14 milligram per day \[mg/day\] and 7 mg/day), in comparison to placebo, for reducing conversion of participants presenting with their first clinical episode consistent with multiple sclerosis (MS) to clinically definite multiple sclerosis (CDMS).

The secondary objectives were:

* To demonstrate the effect of teriflunomide, in comparison to placebo, on:

  * Reducing conversion to definite multiple sclerosis (DMS)
  * Reducing annualized relapse rate (ARR)
  * Reducing disease activity/progression as measured by Magnetic Resonance Imaging (MRI)
  * Reducing accumulation of disability for at least 12 weeks as measured by the Expanded Disability Status Scale (EDSS)
  * Proportion of disability-free participants as assessed by the EDSS
  * Reducing participant-reported fatigue
* To evaluate the safety and tolerability of teriflunomide
* To evaluate the pharmacokinetics (PK) of teriflunomide
* Optional pharmacogenomic testing aimed at assessing the association between the main enzyme systems of teriflunomide metabolism and hepatic safety, and other potential associations between gene variations and clinical outcomes

Detailed description:
The study consisted of 4 periods:

* Screening period: up to 4 weeks,
* Placebo-controlled treatment period: up to 108 weeks (at least 24 weeks for participants who experienced conversion to CDMS),
* Extension treatment period (without placebo-control): the extension period continued until teriflunomide was commercially available in participant's country of residence.
* Post-treatment washout period: 4 weeks after last treatment intake.

The maximal duration of the study period per participant was expected to be 116 weeks if he/she did not continue in the extension treatment period.

Arms: arm 1: Core treatment period: Placebo matched to teriflunomide tablet once daily orally.

Extension treatment period: Re-randomized in 1:1 ratio to either teriflunomide 7 mg or 14 mg once daily orally. arm 2: Core treatment period: Teriflunomide 7 mg tablet once daily orally.

Extension treatment period: Teriflunomide 7 mg tablet once daily orally. arm 3: Core treatment period: Teriflunomide 14 mg tablet once daily orally.

Extension treatment period: Teriflunomide 14 mg tablet once daily orally.
Interventions: intervention 1: Teriflunomide intervention 2: Placebo
Intervention descriptions: intervention 1: Film-coated tablet Oral administration intervention 2: Film-coated tablet Oral administration

Protocol documents:
Clinical trial NCT01408576
Conditions: Systemic Lupus Erythematosus
Keywords: Lupus Monoclonal antibody B-Cell immunotherapy Epratuzumab
Sponsor: UCB Pharma
Start date: 2011-07-01; Completion date: 2016-02-01
Enrollment: 1250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is assess the safety and tolerability of long-term epratuzumab treatment in subjects with Systemic Lupus Erythematosus (SLE)

Detailed description:
Treatment period was extended by 2 years to a total of 4 years and an amendment was prepared accordingly.

Arms: arm 1: 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over sixteen 12-week treatment cycles arm 2: 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over sixteen 12 week treatment cycles
Interventions: intervention 1: Epratuzumab intervention 2: Epratuzumab
Intervention descriptions: intervention 1: 600 mg infusions delivered weekly for a total of 4 consecutive weeks (cumulative dose 2400 mg) over eight 12-week treatment cycles intervention 2: 1200 mg infusions delivered every other week for a total of 4 weeks (cumulative dose 2400 mg) over eight 12 week treatment cycles

Protocol documents:
Clinical trial NCT02133131
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2014-06-13; Completion date: 2016-02-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study of grazoprevir (MK-5172) + elbasvir (MK-8742) and sofosbuvir (SOF) in treatment-naive participants with chronic hepatitis C (HCV) genotype (GT) 1 or GT3. The objective is to determine the proportion of participants achieving sustained virologic response 12 weeks after ending study treatment (SVR12).

Detailed description:
The study is an open-label, single-center, multiple-arm investigation of a fixed-dose combination \[FDC\] of grazoprevir 100mg + elbasvir 50mg, and SOF 400mg, in treatment-naive participants with chronic HCV GT1 or GT3. The impact of study treatment regimens of varying duration on SVR12 (undetectable HCV ribonucleic acid \[RNA\] 12 weeks after ending study treatment) in cirrhotic (C) participants and non-cirrhotic (NC) participants will be determined (Part A). Any HCV GT1 participant from study Arms 1-4 in Part A who experienced virologic relapse will be offered retreatment consisting of 12 additional weeks of treatment with MK-5172/MK-8742 + SOF + ribavirin and 24 weeks of follow-up in Part B.

Arms: arm 1: Participants took grazoprevir/elbasvir (100mg/50mg) FDC with SOF 400mg once daily (q.d.) by mouth for 4 weeks (n=30 planned). arm 2: Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=30 planned). arm 3: Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 6 weeks (n=20 planned). arm 4: Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=20 planned). arm 5: Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 8 weeks (n=15 planned). arm 6: Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=15 planned). arm 7: Participants took grazoprevir/elbasvir (100mg/50mg) FDC + SOF 400mg q.d. by mouth for 12 weeks (n=10 planned).
Interventions: intervention 1: Grazoprevir/Elbasvir FDC intervention 2: Sofosbuvir
Intervention descriptions: intervention 1: FDC tablet containing grazoprevir 100 mg + elbasvir 50 mg taken q.d. by mouth. intervention 2: Sofosbuvir 400mg tablet taken q.d. by mouth.

Protocol documents:
Clinical trial NCT02276222
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: Chronic Obstructive Pulmonary Disease COPD
Sponsor: Sunovion Respiratory Development Inc.
Start date: 2014-10-01; Completion date: 2016-02-01
Enrollment: 1087 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a long-term safety trial of 48 weeks. Eligible subjects will enter the 48-week, open-label treatment period to receive one of two treatments (SUN-101 given as 50 mcg twice a day or Spiriva® \[tiotropium\] given as 18 mcg once a day).

Detailed description:
This is a Phase 3, randomized, open-label, active-controlled, parallel-group, multicenter, long-term safety trial of 48 weeks of treatment with nebulized SUN-101 using an Investigational eFlow® Closed System (CS) nebulizer or Spiriva in approximately 1050 subjects with chronic obstructive pulmonary disease (COPD) according to the Global Initiative for Chronic Obstructive Lung Disease (GOLD 2014) guidelines.

Eligible subjects will enter the 48-week, open-label treatment period following randomization to receive one of two treatments (SUN-101 given as 50 mcg BID or Spiriva® \[tiotropium\] given as 18 mcg QD).

The hypothesis for this study is that the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subjects randomized to SUN-101 is numerically similar to the incidence of treatment-emergent adverse events reported over the course of 48 weeks of treatment by subject randomized to Spiriva (tiotropium).

Arms: arm 1: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer arm 2: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler
Interventions: intervention 1: SUN-101 50 mcg BID eFlow (CS) nebulizer intervention 2: Spiriva® 18 mcg QD Handihaler
Intervention descriptions: intervention 1: SUN-101 (Glycopyrrolate) 50 mcg twice daily (BID) via eFlow Closed System (CS) nebulizer intervention 2: Spiriva (tiotropium) 18 mcg once daily (QD) via Handihaler

Protocol documents:
Clinical trial NCT00405587
Conditions: Malignant Melanoma Colorectal Carcinoma
Sponsor: Plexxikon
Start date: 2006-11-01; Completion date: 2016-02-01
Enrollment: 109 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this FIH study is to assess the safety and pharmacokinetics of PLX4032 in patients with solid tumors. The secondary objective is to assess the pharmacodynamic activity in paired biopsy specimens obtained from patients with malignant melanoma who have the V600E BRAF oncogenic mutation.

Detailed description:
Activating mutations of the BRAF gene have been observed in a variety of cancers, including 55-68% of malignant melanomas. In general, oncogenic mutations of BRAF correlate with a poor outcome. PLX4032 is a compound that selectively inhibits oncogenic B-Raf kinase.

Two extension cohorts of patients with confirmed V600E mutations will be recruited, consisting of advanced melanoma and metastatic colorectal carcinoma.

Arms: arm 1: Open-label, sequential dose escalation
Interventions: intervention 1: PLX4032
Intervention descriptions: intervention 1: Oral capsules administered BID

Protocol documents:
Clinical trial NCT00662038
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: idiopathic pulmonary fibrosis
Sponsor: Genentech, Inc.
Start date: 2008-08-01; Completion date: 2016-02-01
Enrollment: 1058 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. The purpose of this study is to obtain additional safety data for pirfenidone 2403 mg/day in patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone.

Detailed description:
This is an open-label, multi-center, extension study for patients with IPF who complete a qualifying InterMune clinical trial of pirfenidone. Eligible patients must complete the final visit for their qualifying study, have not permanently discontinued study drug in their qualifying study, and meet all of the eligibility criteria noted in this protocol.

Since data from the qualifying study may remain blinded during patient enrollment in PIPF-012, all patients will be treated as if they were taking placebo in their qualifying study. At the start of PIPF-012 participation, each patient will escalate the dose of pirfenidone.

The duration of treatment for each patient will vary and will continue until pirfenidone is commercially or otherwise available in his/her geographic region or the study is terminated by the sponsor for reasons outlined in the protocol.

Arms: arm 1: pirfenidone
Interventions: intervention 1: pirfenidone
Intervention descriptions: intervention 1: Pirfenidone, 2403 mg/d, administered as 801-mg doses, three times daily.

Protocol documents:
Clinical trial NCT00882583
Conditions: Head and Neck Cancer
Keywords: HNSCC Dasatinib Cetuximab Cisplatin
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2009-07-01; Completion date: 2016-02-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective for Phase I

1. To determine the maximally tolerated dose (MTD) of daily Oral dasatinib in combination with cetuximab/RT in Cohort A.
2. To determine the MTD of daily oral dasatinib in combination with cisplatin/cetuximab/RT in Cohort B

Detailed description:
Primary Objective for Phase I

1. To determine the maximally tolerated dose (MTD) of daily Oral dasatinib in combination with cetuximab/RT in Cohort A, in patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx.
2. To determine the MTD of daily oral dasatinib in combination with cisplatin/cetuximab/RT in Cohort B, in patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of oral cavity, oropharynx, hypopharynx, and larynx.

Arms: arm 1: In Cohort A , there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib at specific dose level from day 8-14.

Cohort A will consist of patients with AJCC stage II (T2N0) and III (T1-2N1) SCCHN of oral cavity, oropharynx, T2N0 hypopharynx, T2N0-1 supraglottic larynx. Treatment will be dasatinib at specific dose level in combination with cetuximab 250mg/m2 IV and radiation therapy (RT) 70Gy at 2Gy/fn. arm 2: In Cohort B, there will be an initial "run-in period" of single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 and oral dasatinib at specific dose level from day 8-14.

Cohort B will include patients with AJCC stage III (T3N0-1) and IV (T1-4N2-3M0, T4N0-1M0) squamous cell carcinoma of Oral Cavity, Oropharynx, Hypopharynx, and Larynx. Treatment will be daily dasatinib at specific dose level, in combination with q 3 week cisplatin 75mg/m2, weekly cetuximab 250mg/m2 IV and RT 70Gy ( 2gy per fraction).
Interventions: intervention 1: Cetuximab intervention 2: Dasatinib intervention 3: Cisplatin intervention 4: Radiation Therapy
Intervention descriptions: intervention 1: single agent cetuximab loading dose of 400mg/m2 on day1, cetuximab maintenance dose 250mg/m2 on day 8 intervention 2: Oral Dasatinib Days 8 through 64. intervention 3: Q 3 weeks (Days 15, 36 and 57): +/- 3 Days intervention 4: Standard Radiation Therapy.

Protocol documents:
Clinical trial NCT01003990
Conditions: HIV
Keywords: Treatment experienced
Sponsor: Bristol-Myers Squibb
Start date: 2002-10-01; Completion date: 2016-02-01
Enrollment: 710 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to provide atazanavir or tenofovir-emtricitabine to HIV-infected subjects who have completed atazanavir or tenofovir-emtricitabine therapy on a previous BMS sponsored clinical trial and to collect long-term safety information on the treated population.

Detailed description:
Provide study drug for patients rolling off BMS ATV clinical trials in countries where these medications are not commercially available.

Arms: arm 1: None arm 2: None arm 3: Ritonavir-boosted Lopinavir (LPV/RTV 400/100 mg) administered twice a day (BID) with Tenofovir/ Emtricitabine (TDF/FTC).
Interventions: intervention 1: Atazanavir intervention 2: Atazanavir/Ritonavir intervention 3: Tenofovir/Emtricitabine intervention 4: Lopinavir/ritonavir
Intervention descriptions: intervention 1: Tablets, Oral, 400 mg, once daily, indefinitely intervention 2: Tablets, Oral, 300/100 mg, once daily, indefinitely intervention 3: Tablets, Oral, 300/200 mg, once daily, indefinitely intervention 4: Tablets, Oral, 400/100 mg, twice daily, indefinitely

Protocol documents:
Clinical trial NCT01004991
Conditions: Diffuse Large B Cell Lymphoma
Sponsor: Weill Medical College of Cornell University
Start date: 2010-01-01; Completion date: 2016-02-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase I/II open label, multi-center study of azacytidine in combination with standard RCHOP therapy in patients with DLBCL. Patients will be treated with azacytidine at escalating doses on days 1-5, followed by standard dose rituximab plus CHOP chemotherapy on day 8, every 21 days. Patients will be treated for a total 6 cycles. The phase II portion will then evaluate efficacy of the combination at the established MTD.

Detailed description:

Arms: arm 1: subjects will receive azacytidine dose dependent on dose-escalation schedule at time of enrollment - all will receive standard dose RCHOP
Interventions: intervention 1: rituximab intervention 2: cyclophosphamide intervention 3: vincristine intervention 4: doxorubicin intervention 5: prednisone intervention 6: azacytidine
Intervention descriptions: intervention 1: 375 mg/m2 on Day 8 of each of 6 cycles intervention 2: 750 mg/m2 on Day 8 of each of 6 cycles intervention 3: 1.4 mg/m2 on Day 8 of each of 6 cycles intervention 4: 50 mg/m2 on Day 8 of each of 6 cycles intervention 5: 100 mg PO days 8-12 of each of 6 cycles intervention 6: Dose level 1: azacytidine 25 mg/m2 days 1-5 Dose level 2: azacytidine 50 mg/m2 days 1-5 Dose level 3: azacytidine 75 mg/m2 days 1-5

Protocol documents:
Clinical trial NCT01013597
Conditions: Thyroid Carcinoma
Keywords: thyroid medullary differentiated radioiodine-resistant LBH589 panobinostat
Sponsor: University of Wisconsin, Madison
Start date: 2010-01-01; Completion date: 2016-02-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the tumor response rate in patients with metastatic medullary thyroid cancer (MTC) or radioiodine resistant differentiated thyroid cancer (DTC) after receiving treatment with LBH589 20 mg by mouth, three times weekly. Time to progression, overall survival, toxicity, tolerability, and Notch1 protein expression patterns will also be evaluated.

Detailed description:
Medullary thyroid cancer (MTC) is a neuroendocrine tumor and accounts for 3-5% of cases of thyroid cancer. The majority of patients with MTC do not present with early stage disease. Differentiated thyroid cancer (DTC) accounts for \>90% of all thyroid cancers. In a sub-set of patients, thyroid cells become resistant to I-131 radioiodine therapy and subsequently develop distant metastases. In both MTC and DTC, systemic chemotherapy for metastatic disease is largely ineffective.

LBH589 is a histone deacetylase (HDAC) with recently demonstrated activity to inhibit the Notch1 signaling pathway in MTC cancer cells and suppress tumor cell proliferation in DTC cancer cells. This clinical trial will evaluate the tumor response rate of LBH589 in patients with metastatic MTC or radioactive iodine resistant DTC.

Arms: arm 1: None
Interventions: intervention 1: LBH589
Intervention descriptions: intervention 1: LBH589 20mg by mouth three times weekly (Monday/Wednesday/Friday) for 28-day cycles.

Protocol documents:
Clinical trial NCT01083732
Conditions: Venous Thromboembolism
Sponsor: Boehringer Ingelheim
Start date: 2010-03-01; Completion date: 2016-02-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the safety and tolerability of dabigatran etexilate solution in children and to obtain preliminary pharmacokinetic/pharmacodynamic data

Detailed description:
Purpose:

Arms: arm 1: treatment with dabigatran oral solution as a single dose
Interventions: intervention 1: dabigatran etexilate
Intervention descriptions: intervention 1: Experimental dose chosen based on age and weight

Protocol documents:
Clinical trial NCT01121211
Conditions: Anorexia Nervosa Eating Disorder Anxiety Depression
Keywords: Testosterone Hormones Mental Health
Sponsor: Massachusetts General Hospital
Start date: 2010-04-01; Completion date: 2016-02-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators are investigating whether a hormone that is naturally produced by the human body, called testosterone, can help improve weight, disordered eating, depression, and anxiety. The investigators hypothesize that testosterone will be a novel and effective endocrine-targeted therapy for patients with anorexia nervosa.

Detailed description:

Arms: arm 1: Testosterone x 24 weeks arm 2: Placebo x 24 weeks
Interventions: intervention 1: Testosterone intervention 2: Placebo
Intervention descriptions: intervention 1: Testosterone 300mcg transdermal patch x 24 weeks. intervention 2: Placebo transdermal patch x 24 weeks

Protocol documents:
Clinical trial NCT01166945
Conditions: Sinusitis
Keywords: Child Child, preschool Sinusitis Antimicrobial agents
Sponsor: University of Wisconsin, Madison
Start date: 2010-11-01; Completion date: 2016-02-01
Enrollment: 98 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators objective is to compare short course (5 days) to long course (14 days)antibiotics for the treatment of acute bacterial sinusitis in children. The investigators hypothesize that short course therapy will lead to more frequent relapses of sinusitis and will not reduce resistant organisms.

Detailed description:
This was a prospective, randomized, double-blind study comparing short course (5 days) to long course (14 days) antimicrobial therapy for children between 1 and 10 years of age with acute bacterial sinusitis. The major outcome measure is the proportion of children with a clinical relapse on day 10 in the short course therapy group compared to day 20 in the long course therapy group. In addition, the proportion of respiratory flora that are resistant to antibiotics on day 30 will be compared to baseline in each group.

Arms: arm 1: Short course (5 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination and placebo for next 9 days. arm 2: Long course (14 days) of antimicrobial therapy Amoxicillin-Potassium Clavulanate Combination given orally for 14 days.
Interventions: intervention 1: Amoxicillin-Potassium Clavulanate Combination intervention 2: Placebo
Intervention descriptions: intervention 1: All subjects will be started on treatment with 5 days of high dose amoxicillin (90mg/kg) with potassium clavulanate (6.4 mg/kg) twice daily in bottle A. The allocation to group B1 or B2 will be concealed until after the family and subject has signed the assent and consent, respectively. The maximum dose will be 2 gms twice daily. After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days. intervention 2: After 5 days the subjects will be randomized to either continue to receive the same dose of amoxicillin clavulanate or a look-a-like and taste-a-like placebo for the next 9 days.

Protocol documents:
Clinical trial NCT01259375
Conditions: Soft Tissue Sarcoma
Sponsor: University of Utah
Start date: 2011-09-01; Completion date: 2016-02-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objectives

1. To evaluate the Response Rate (RR) for amrubicin in patients with metastatic or advanced sarcoma as first line therapy.
2. To evaluate Progression Free Survival (PFS).

Secondary Objectives

1. To assess the safety and tolerability of amrubicin in this patient population.
2. To evaluate whether certain histologic subtypes of sarcoma demonstrate a differential response to amrubicin.
3. To investigate quality of response with radiographic evaluation using both Response Evaluation Criteria In Solid Tumors (RECIST) and Choi criteria.
4. To evaluate overall survival (OS).

Detailed description:

Arms: arm 1: All participants who received Amrubicin.
Interventions: intervention 1: Amrubicin
Intervention descriptions: intervention 1: Synthetic 9-aminoanthracycline Patients will receive 40mg/m2/day intravenously

Protocol documents: