ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02358044
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2015-02-27; Completion date: 2016-02-16
Enrollment: 257 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study comparing grazoprevir (MK-5172) plus elbasvir (MK-8742) treatment with sofosbuvir (SOF) plus Pegylated Interferon plus Ribavirin (RBV) \[PR\] treatment in treatment-naïve and prior PR treatment failure participants with chronic Hepatitis C Virus (HCV) genotype (GT)1, GT4, or GT6 infection. The primary objectives are to compare efficacy (assessed by the percentage of participants achieving sustained virologic response 12 weeks after ending study treatment \[SVR12\]) and safety between the grazoprevir plus elbasvir treatment arm and the SOF plus PR treatment arm. The primary hypothesis is that the percentage of participants achieving SVR12 in the grazoprevir plus elbasvir treatment arm is non-inferior to that in the SOF plus PR treatment arm.

Detailed description:

Arms: arm 1: Participants receive a fixed-dose combination (FDC) tablet of 100 mg grazoprevir and 50 mg elbasvir for 12 weeks, followed by 24 weeks of follow-up. arm 2: Participants receive SOF (400 mg) combined with PegIntron (1.5 mcg/kg) plus RBV (1000-1200 mg weight-based dose) for 12 weeks, followed by 24 weeks of follow-up.
Interventions: intervention 1: Sofosbuvir intervention 2: PegIntron intervention 3: Ribavirin intervention 4: Grazoprevir/Elbasvir (100 mg/50 mg) FDC
Intervention descriptions: intervention 1: 400 mg tablets, taken orally (PO) every day (QD) for 12 weeks. intervention 2: PegIntron administered subcutaneously every week (QW) at 1.5 mcg/kg for 12 weeks. intervention 3: Capsule and/or tablet administered PO twice daily (BID) based on weight (1000 - 1200 mg) for 12 weeks. intervention 4: Grazoprevir/Elbasvir (100 mg/50 mg) FDC, taken PO QD for 12 weeks.

Protocol documents:
Clinical trial NCT02466425
Conditions: Attention Deficit Hyperactivity Disorder (ADHD)
Sponsor: Shire
Start date: 2015-06-18; Completion date: 2016-02-16
Enrollment: 264 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is designed to evaluate the efficacy and safety of SHP465 in the treatment of ADHD in children and adolescents (aged 6-17 years). The primary objective of this study is to evaluate the efficacy of SHP465 administered as a daily morning dose compared to placebo in the treatment of children and adolescents (6-17 years of age inclusive) diagnosed with ADHD.

Detailed description:

Arms: arm 1: Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours) arm 2: Subjects will receive SHP465 (12.5mg and 25mg capsules) or matching placebo. Subjects will take 1 capsule daily throughout the study at approximately 7:00am (+/- 2 hours)
Interventions: intervention 1: SHP465 intervention 2: Placebo
Intervention descriptions: intervention 1: 12.5mg and 25mg capsules (one capsule daily) intervention 2: Matching placebo capsule that appear identical in size, weight, shape, color

Protocol documents:
Clinical trial NCT02246998
Conditions: HIV-1 Infection
Sponsor: Gilead Sciences
Start date: 2014-12-15; Completion date: 2016-02-17
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess glomerular function before and during administration of stribild (STB; elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate (E/C/F/TDF)) or a regimen containing TDF without cobicistat (COBI) as ritonavir (RTV)-boosted atazanavir (ATV/r) plus truvada (TVD; FTC/TDF) or atripla (ATR; efavirenz/emtricitabine/tenofovir disoproxil fumarate (EFV/FTC/TDF)) compared to a regimen containing neither TDF nor COBI as ATV/r plus abacavir/lamivudine (ABC/3TC) via determination of actual glomerular filtration rate (aGFR) using iohexol (a probe GFR marker) plasma clearance and estimated (calculated) glomerular filtration rate (eGFR).

Detailed description:

Arms: arm 1: Participants will receive STB+iohexol for 24 weeks. arm 2: Participants will receive RTV+ATV+TVD+iohexol for 24 weeks. arm 3: Participants will receive ATR+iohexol for 24 weeks. arm 4: Participants will receive RTV+ATV+ABC/3TC+iohexol for 24 weeks.
Interventions: intervention 1: STB intervention 2: TVD intervention 3: ATR intervention 4: RTV intervention 5: ATV intervention 6: ABC/3TC intervention 7: Iohexol
Intervention descriptions: intervention 1: 150/150/200/300 mg fixed dose combination (FDC) tablet administered orally once daily with food intervention 2: 200/300 mg FDC tablet administered orally once daily with food intervention 3: 600/200/300 mg FDC tablet administered orally once daily on an empty stomach at bedtime intervention 4: 100 mg tablet administered orally once daily with food intervention 5: 300 mg capsule administered orally once daily with food intervention 6: 600/300 mg FDC tablet administered orally once daily with food intervention 7: 1500 mg solution administered intravenously at baseline, and at Weeks 4, 8, 16, and 24

Protocol documents:
Clinical trial NCT00210353
Conditions: Lymphoma, Mucosa-Associated Lymphoid Tissue
Sponsor: International Extranodal Lymphoma Study Group (IELSG)
Start date: 2003-01-01; Completion date: 2016-02-17
Enrollment: 454 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Assess the therapeutic activity and safety of the combination of Chlorambucil and Rituximab in MALT lymphomas and determine whether the addition of Rituximab to Chlorambucil will improve the outcome of MALT lymphoma in comparison to treatment with Chlorambucil alone.

In April 2006, a third arm of treatment was added to compare the antitumor activity and safety of rituximab alone vs chlorambucil alone

Detailed description:

Arms: arm 1: chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment; two weeks rest; chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles) arm 2: rituximab 375 mg/m2 iv, d1, d8, d15, d22 chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment two weeks rest chlorambucil 6 mg/m2 os daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle arm 3: rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140
Interventions: intervention 1: chlorambucil (drug) intervention 2: rituximab+chlorambucil intervention 3: rituximab
Intervention descriptions: intervention 1: chlorambucil 6 mg/m2 daily during the first 6 weeks of treatment, two weeks rest, chlorambucil 6 mg/m2 daily during the first two of a four weeks cycles (total of 4 cycles) intervention 2: rituximab 375 mg/m2 iv, d1, 8, 15, 22, chlorambucil 6 mg/m2 os, daily during the first 6 weeks of treatment, ; two weeks rest; chlorambucil 6 mg/m2 os, daily during the first two of a four weeks cycles (total of 4 cycles) rituximab 375 mg/m2 iv at day 1 of each cycle intervention 3: rituximab 375 mg/m2 iv on days 1, 8, 15, 22, 56, 84, 112, 140

Protocol documents:
Clinical trial NCT02029274
Conditions: Active Dermatomyositis
Keywords: Dermatomyositis
Sponsor: Novartis Pharmaceuticals
Start date: 2013-08-25; Completion date: 2016-02-17
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study investigated the dose response relationship for the efficacy and safety of BAF312 compared to placebo in active DM patients over a treatment period of 6+6 months and to determine the minimum dose required for a maximal clinical effect. The study was composed of 2 periods: a double-blind period 1 with BAF312 administered at different daily doses (0.5, 2, 10 mg and placebo) and a fixed-dose Period 2 in which BAF312 was administered at the dose of 2 mg daily .

Detailed description:
The study was prematurely terminated based on the results of an interim analysis where BAF312 did not demonstrate superior efficacy over placebo and a dose-response relationship was not observed. There were no safety concerns. Approximately 56 participants were planned to be randomized. A total of 17 participants were enrolled and randomized by the time the study was terminated.

Arms: arm 1: During period 1, participants were uptitrated daily from BAF312 0.25 mg to 0.5 mg over a 10 day period. After, participants continued on 0.5 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. arm 2: During period 1, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. arm 3: During period 1, participants were uptitrated daily from BAF312 0.25 mg to 10.0 mg over a 10 day period. After, participants continued on 10.0 mg daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks. arm 4: During period 1, participants received matching placebo daily for up to 24 weeks. During period 2, participants were uptitrated daily from BAF312 0.25 mg to 2.0 mg over a 10 day period. After, participants continued on 2.0 mg daily for up to 24 weeks.
Interventions: intervention 1: BAF312 intervention 2: Placebo
Intervention descriptions: intervention 1: BAF312 was provided as film-coated tablets in strengths of 0.25, 0,5, 1 and 2 mg for oral administration. intervention 2: Matching placebo to BAF312 as tablets for oral administration.

Protocol documents:
Clinical trial NCT02557399
Conditions: Acne Vulgaris
Keywords: Clindamycin Gel Benzoyl Peroxide Acne Vulgaris
Sponsor: GlaxoSmithKline
Start date: 2015-10-07; Completion date: 2016-02-17
Enrollment: 350 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicentre, randomized, single-blind (investigator is blinded), active (the combination therapy of adapalene \[ADA\] and clindamycin \[CLDM\])-controlled and parallel-group study in Japanese subjects with facial acne vulgaris. The purpose of this study is to evaluate the efficacy, safety and tolerability of CLDM 1 percent (%)-benzoyl peroxide 3% (Duac®: trademark owned by GlaxoSmithKline) once daily fixed dose combination gel versus combination therapy of ADA 0.1% gel and CLDM 1% gel in the topical treatment of facial acne vulgaris for 12 weeks. A total of 400 subjects will be screened for enrolment. Subjects will use Duac® fixed dose combination gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) or combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks.

Detailed description:
Duac® is a registered trademark of Stiefel Laboratories, Inc., a GSK company. Duac® marketed in Japan is CLDM 1%-benzoyl peroxide 3% combination gel.

Arms: arm 1: Subjects will use Duac® fixed dose combination gel (clindamycin phosphate 1.2% and benzoyl peroxide 3%) with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) for 12 weeks. arm 2: Subjects will use combination therapy of ADA 0.1% gel with quantity sufficient to cover entire face (including the forehead, nose, cheeks and chin) once daily in the evening (at bedtime) and subjects will also apply CLDM 1% gel twice daily, once in the morning and once in the evening (at bedtime) for 12 weeks. The CLDM 1% gel should apply subsequent to the application of ADA 0.1% gel in the evening. The CLDM 1% gel should be applied to ILs only.
Interventions: intervention 1: Duac® fixed dose combination gel intervention 2: ADA 0.1% gel intervention 3: CLDM 1% gel
Intervention descriptions: intervention 1: Duac® fixed dose combination gel containing clindamycin phosphate 1.2% and benzoyl peroxide 3%. intervention 2: ADA 0.1% gel containing 0.1% of adapalene. intervention 3: CLDM 1% gel containing clindamycin phosphate 1.2% (1% as clindamycin).

Protocol documents:
Clinical trial NCT01759511
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis IPF
Sponsor: Gilead Sciences
Start date: 2012-10-18; Completion date: 2016-02-19
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with idiopathic pulmonary fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.

Detailed description:

Arms: arm 1: Participants will receive simtuzumab.
Interventions: intervention 1: Simtuzumab
Intervention descriptions: intervention 1: 200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)

Protocol documents:
Clinical trial NCT01846663
Conditions: Hepatic Encephalopathy
Keywords: Hepatic Encephalopathy Liver Failure Hepatic Insufficiency Liver Diseases Brain Diseases Rifaximin Cirrhosis
Sponsor: Bausch Health Americas, Inc.
Start date: 2013-04-03; Completion date: 2016-02-22
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety of Rifaximin or placebo in subjects with severe hepatic impairment and Hepatic Encephalopathy.

Detailed description:

Arms: arm 1: Rifaximin, oral, 550 mg BID, 6 months of treatment arm 2: Placebo, oral, 0 mg BID, 6 months of treatment
Interventions: intervention 1: Placebo intervention 2: Rifaximin
Intervention descriptions: intervention 1: Placebo, oral, 0 mg BID, 6 months of treatment intervention 2: Rifaximin, oral, 550 mg BID, 6 months treatment

Protocol documents:
Clinical trial NCT01931033
Conditions: Autism Spectrum Disorders Pervasive Developmental Disorders ASD PDD
Keywords: Autism Spectrum Disorders Pervasive Developmental Disorders ASD PDD Oxytocin Syntocinon treatment
Sponsor: Massachusetts General Hospital
Start date: 2013-10-01; Completion date: 2016-02-22
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is an 8-week open-label trial testing oxytocin nasal spray (Syntocinon) as a treatment for social impairment in adolescents with autism spectrum disorders (ASD). We hypothesize that oxytocin nasal spray will be safe, tolerable, and effective in improving the core symptoms of autism spectrum disorders in adolescents ages 11-17.

Detailed description:

Arms: arm 1: Intranasal Oxytocin (brand name Syntocinon) will be administered daily (for a total daily dose of 48 IU) for 8 weeks.
Interventions: intervention 1: Intranasal Oxytocin
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT02007278
Conditions: Type 2 Diabetes Hypoglycemia
Keywords: diabetes hypoglycemia glycemic variability vildagliptin glimepiride
Sponsor: Novartis Pharmaceuticals
Start date: 2014-01-03; Completion date: 2016-02-22
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to compare the effect of a fixed dose combination of vildagliptin plus metformin versus combination therapy of glimepiride plus metformin in glycemic variability in patients with type 2 diabetes who have not achieved adequate control of their disease prior to treatment with metformin monotherapy in optimal doses.

Detailed description:

Arms: arm 1: Based on basal dose of metformin, administration of vildagliptin/metformin 50 mg/850 mg twice daily (bid) or 50 mg/1000 mg bid for 12 weeks arm 2: Protocol specified dosage and frequency of glimepiride + metformin for 12 weeks based on basal dose of metformin
Interventions: intervention 1: vildagliptin and metformin (combination) intervention 2: glimepiride intervention 3: Metformin
Intervention descriptions: intervention 1: vildagliptin and metformin combination therapy as 50mg/850mg bid or 50mg/1000mg bid intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT03330457
Conditions: Bleeding
Sponsor: Portola Pharmaceuticals
Start date: 2015-08-06; Completion date: 2016-02-22
Enrollment: 18 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, single center study in healthy volunteers dosed to steady state with betrixaban, designed to (1) Determine an andexanet dosing regimen required to reverse anticoagulant activity of betrixaban in healthy subjects, (2) Assess the safety and tolerability of andexanet vs. placebo (3) Determine the PK properties of andexanet and betrixaban (4) Determine the PD properties of betrixaban before, during, and after receiving andexanet or placebo and (5) Investigate the immunogenicity of andexanet in the presence of betrixaban.

Detailed description:

Arms: arm 1: Andexanet 800 mg, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days arm 2: Placebo, administered as a slow IV bolus after having been dosed to steady-state with betrixaban 80 mg PO once daily (QD) for 7 days arm 3: andexanet 800 mg administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban arm 4: Placebo administered as a slow IV bolus at a target rate of approximately 30 mg/min followed by a continuous infusion of up to 8 mg/min for 120 min (960 mg) starting 4 h after the last dose of betrixaban
Interventions: intervention 1: Andexanet alfa (bolus) intervention 2: Betrixaban 80 mg PO QD intervention 3: Andexanet alfa (infusion IV)
Intervention descriptions: intervention 1: fXa inhibitor antidote intervention 2: fXa inhibitor intervention 3: fXa inhibitor antidote

Protocol documents:
Clinical trial NCT00594815
Conditions: Lymphoma
Keywords: Lymphoma Central Nervous System
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2002-08-28; Completion date: 2016-02-23
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. The investigators hope that the addition of rituximab will improve the control of the tumor.

Detailed description:
The purpose of this study is to find out if immunotherapy (rituximab) added to chemotherapy is a safe treatment for primary central nervous system lymphoma (PCNSL). PCNSL is a rare tumor. It is usually treated with chemotherapy and radiation. This combination prolongs survival, but about half of patients relapse. We hope that the addition of rituximab will improve the control of your tumor.

The second goal of this study is to assess a lower dose of brain radiation. Brain radiation may cause memory loss or dementia. For patients over the age of 60, the risk of significant memory loss is 80-90%. The risk for younger patients is smaller but less clear. In this, study patients whose tumors are in remission after chemotherapy will be treated with a lower dose of brain radiation. We hope that this lower dose will be less toxic. However, it is also possible that using a lower dose of radiation will be less effective in controlling your tumor.

Arms: arm 1: None
Interventions: intervention 1: Cytarabine, Leucovorin, Methotrexate, Procarbazine, Rituximab, Vincristine
Intervention descriptions: intervention 1: Immunochemotherapy

Protocol documents:
Clinical trial NCT01011894
Conditions: Chronic Lymphocytic Leukemia Leukemia
Keywords: Lenalidomide CLL 09-045
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2009-11-06; Completion date: 2016-02-23
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to:

Determine the likelihood that lenalidomide will adequately control the disease for at least one year.

Lenalidomide is a drug that alters the immune system and it may also interfere with the development of tiny blood vessels that help support tumor growth. Therefore, in theory, it may reduce or prevent the growth of cancer cells. Lenalidomide is approved by the Food and Drug Administration (FDA) for the treatment of specific types of myelodysplastic syndrome (MDS) and in combination with dexamethasone for patients with multiple myeloma (MM) who have received at least 1 prior therapy. MDS and MM are cancers of the blood. It is currently being tested in a variety of cancer conditions.

In this case it is considered experimental. The lenalidomide being administered in this study is not a commercially marketed product. Although it is expected to be very similar in safety and activity to the commercially marketed drug, it is possible that some differences may exist. Because this is not a commercially marketed drug, lenalidomide can only be administered to patients enrolled in this clinical trial and may only be administered under the direction of physicians who are investigators in this clinical trial.

Detailed description:

Arms: arm 1: Patients with intermediate or high-risk chronic lymphocytic leukemia (≥ 65 years old) will receive lenalidomide until disease progression at the 20mg dose level (recognizing that progression at this dose requires non-protocol alternate therapy) or unacceptable toxicity.
Interventions: intervention 1: lenalidomide
Intervention descriptions: intervention 1: Lenalidomide will be administered orally at a starting dose of 2.5mg once daily, days 1-28. Patients will be evaluated prior to treatment and at 4 weeks, 8 weeks, 12 weeks, 16 weeks and at a minimum of 4 weeks thereafter until removal from study. Patients with stable disease or better will continue at their current dose unless they experience toxicity requiring dose reduction. For those patients who have progressive disease on their current dose and have no dose-limiting toxicity, their dose will be increased from 2.5mg, to 5mg, to 10mg, to 15mg, to 20mg one dose level at a time not more frequently than once every 4 weeks. The maximum dose will be 20mg.

Protocol documents:
Clinical trial NCT01769196
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Idiopathic Pulmonary Fibrosis IPF
Sponsor: Gilead Sciences
Start date: 2013-01-31; Completion date: 2016-02-23
Enrollment: 544 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.

Detailed description:

Arms: arm 1: Participants will receive simtuzumab for up to 254 weeks. arm 2: Participants will receive simtuzumab placebo for up to 254 weeks.
Interventions: intervention 1: Simtuzumab intervention 2: Simtuzumab placebo
Intervention descriptions: intervention 1: 125 mg/mL single-dose vials administered subcutaneously once a week intervention 2: Simtuzumab placebo single-dose vials administered subcutaneously once a week

Protocol documents: