ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01826487
Conditions: Muscular Dystrophy, Duchenne Muscular Dystrophies Muscular Disorders, Atrophic Muscular Diseases Musculoskeletal Diseases Neuromuscular Diseases Nervous System Diseases Genetic Diseases, X-Linked Genetic Diseases, Inborn
Keywords: Duchenne muscular dystrophy Dystrophinopathy Nonsense mutation Premature stop codon Becker muscular dystrophy DMD/BMD PTC124 Ataluren
Sponsor: PTC Therapeutics
Start date: 2013-03-26; Completion date: 2015-08-20
Enrollment: 230 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Dystrophinopathy is a disease continuum that includes Duchenne muscular dystrophy, which develops in boys. It is caused by a mutation in the gene for dystrophin, a protein that is important for maintaining normal muscle structure and function. Loss of dystrophin causes muscle fragility that leads to weakness and loss of walking ability. A specific type of mutation, called a nonsense (premature stop codon) mutation is the cause of dystrophinopathy in approximately 10-15 percent (%) of boys with the disease. Ataluren is an orally delivered, investigational drug that has the potential to overcome the effects of the nonsense mutation. The main goal of this Phase 3 study is to evaluate the effect of ataluren on walking ability. The effect of ataluren on physical function, quality of life, and activities of daily living will be evaluated. This study will also provide additional information on the long-term safety of ataluren.

Detailed description:
This is a Phase 3, multicenter, randomized, double-blind, placebo-controlled study to determine the efficacy and safety of ataluren in participants with nmDMD.

Arms: arm 1: Participants will receive placebo matching to ataluren orally 3 times a day (TID) at morning, midday, and evening for 48 weeks. arm 2: Participants will receive ataluren suspension orally TID, 10 milligrams/kilogram (mg/kg) at morning, 10 mg/kg at midday, and 20 mg/kg at evening (total daily dose 40 mg/kg) for 48 weeks.
Interventions: intervention 1: Ataluren intervention 2: Placebo
Intervention descriptions: intervention 1: Ataluren will be administered as per the dose and schedule specified in the arm. intervention 2: Placebo will be administered as per the schedule specified in the arm.

Protocol documents:
Clinical trial NCT02168270
Conditions: Anaplastic Astrocytoma Anaplastic Oligodendroglioma Anaplastic Oligoastrocytoma Glioblastoma Gliosarcoma
Sponsor: University of Nebraska
Start date: 2014-06-16; Completion date: 2015-08-20
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I trial studies the side effects and best dose of ascorbic acid when given together with temozolomide in treating patients with high-grade glioma that has come back. Drugs used in chemotherapy, such as temozolomide, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Ascorbic acid contains ingredients that may prevent or slow the growth of high-grade gliomas. Giving temozolomide with ascorbic acid may kill more tumor cells.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the toxicities and determine the recommended dose of intravenous ascorbic acid given three times weekly in combination with temozolomide in patients with recurrent high grade glioma.

SECONDARY OBJECTIVES:

I. To evaluate changes in the levels of serum ascorbic acid using high-performance liquid chromatography (HPLC) with coulometric electrochemical detection) during therapy with ascorbic acid and temozolomide.

II. Radiographic assessment of disease status after 2 cycles of therapy with ascorbic acid and temozolomide.

III. To evaluate progression-free and overall survival of patients with recurrent high grade glioma treated with therapy with ascorbic acid and temozolomide.

IV. To descriptively examine quality of life (QOL) using European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaires (QLQ)-C30 during treatment.

OUTLINE: This is a dose-escalation study of ascorbic acid.

Patients receive ascorbic acid intravenously (IV) over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up at 30 days, every 2 months for 1 year and then periodically thereafter.

Arms: arm 1: Patients receive ascorbic acid IV over 90-120 minutes three times per week and temozolomide orally days 1-28. Treatment repeats every 4 weeks for up to 12 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: ascorbic acid intervention 2: temozolomide intervention 3: quality-of-life assessment intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given IV intervention 2: Given PO intervention 3: Ancillary studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT02209324
Conditions: Herpes Simplex
Sponsor: Maruho Co., Ltd.
Start date: 2013-11-01; Completion date: 2015-08-20
Enrollment: 275 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A multicenter, open-label study is conducted to evaluate the efficacy and safety of ASP2151 in patients with herpes simplex (recurrent labial/facial herpes and recurrent genital herpes and Kaposi varicelliform).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: ASP2151
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01978938
Conditions: cUTI
Sponsor: Tetraphase Pharmaceuticals, Inc
Start date: 2014-10-06; Completion date: 2015-08-21
Enrollment: 908 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase 3, randomized, double-blind, double-dummy, multicenter, prospective study to assess the efficacy and safety of eravacycline compared with levofloxacin in participants with complicated urinary tract infections (cUTI).

Detailed description:
This study began with a 3-arm Lead-in portion to determine the oral (PO) dosing (200 or 250 milligrams \[mg\]) of eravacycline to be used with intravenously (IV) administered eravacycline for the Pivotal portion (2 arms). A PO dose of 200 mg was selected based on the unblinded Lead-in analysis.

Arms: arm 1: Eravacycline was administered IV at a dose of 1.5 mg per kilogram (kg) of body weight every 24 hours (q24h). At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 200 mg PO twice a day for a total therapy of 7 dosing cycles. arm 2: Levofloxacin (750 mg) was administered IV q24h. At minimum, the first 3 doses were administered IV. After an IV-to-PO transition, provided adequate clinical improvement, participants were administered 750 mg PO once a day for a total therapy of 7 dosing cycles.
Interventions: intervention 1: Eravacycline intervention 2: Levofloxacin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02477709
Conditions: Idiopathic Pulmonary Fibrosis
Sponsor: Afferent Pharmaceuticals, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2015-07-20; Completion date: 2015-08-21
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study assesses the tolerability of a single dose of gefapixant (AF-219) in participants with idiopathic pulmonary fibrosis (IPF). Six eligible participants will receive a single 150 mg dose of gefapixant and undergo tolerability and PK assessments.

Detailed description:
This study assesses the tolerability of a single dose of gefapixant in participants with idiopathic pulmonary fibrosis (IPF).

This will be the first experience of administering gefapixant in patients with IPF. P2X3 receptors are found on the chemosensory afferents of the carotid body and can influence sympathetic autonomic discharge, especially in sensitized subjects; accordingly, by blocking these P2X3 receptors, gefapixant may have an effect of reducing sympathetic activity. Therefore in order to determine whether P2X3 antagonism would have an effect on the hemodynamic measures such as blood pressure in patients with IPF, study AF219-019 is being performed. These patients will be closely monitored in order to determine any such effect.

Arms: arm 1: Gefapixant oral tablets (150 mg) administered as a single dose
Interventions: intervention 1: Gefapixant
Intervention descriptions: intervention 1: Gefapixant oral tablet (150 mg administered as three 50 mg tablets) - single dose only

Protocol documents:
Clinical trial NCT01919801
Conditions: Angiotensin Converting Enzyme Inhibitor Induced Angioedema
Keywords: icatibant Firazyr ACE-I
Sponsor: Shire
Start date: 2013-12-02; Completion date: 2015-08-22
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the safety and efficacy of icatibant with placebo in the treatment for Angiotensin-Converting Enzyme Inhibitor (ACE-I)-Induced Angioedema in Adults.

Detailed description:
Angiotensin-converting enzyme inhibitors (ACE-Is) are the class of medications prescribed most frequently for the treatment of hypertension. They are also used post myocardial infarction as well as in patients with heart failure, diabetes mellitus, and chronic kidney disease. Approximately 35 to 40 million patients are on ACE-Is worldwide.

Study HGT-FIR-096 is a multicenter, Phase III, randomized, double-blind, two-armed, placebo-controlled trial. The study population will consist of 118 adult patients, 18 years of age or older, who present with an acute ACE-I-induced angioedema attack. The primary aim of the study is to demonstrate that icatibant is significantly more effective than placebo in resolving attacks of angioedema caused by ACE-I based on the Time to Meeting Discharge Criteria (TMDC). Safety and tolerability, as well as the pharmacokinetics (PK), of icatibant will also be evaluated. Eligible patients will be randomized at a 1:1 ratio to receive a single sub-cutaneous injection of either 30 mg icatibant or placebo.

Arms: arm 1: Icatibant at a dose of 30 mg will be administered as a single subcutaneous injection arm 2: Placebo will be administered as a single subcutaneous injection
Interventions: intervention 1: Icatibant intervention 2: Placebo
Intervention descriptions: intervention 1: Single dose of 30 mg icatibant administered within 12 hours of the onset of an acute attack of ACE-I-induced angioedema intervention 2: None

Protocol documents:
Clinical trial NCT02210000
Conditions: Gastroparesis
Keywords: repeat dose phase II GCSI-DD pharmacodynamics gastroparesis type 1 and type 2 diabetes mellitus camicinal GSK962040 symptoms gut motility
Sponsor: GlaxoSmithKline
Start date: 2014-08-27; Completion date: 2015-08-24
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized, double-blind, placebo controlled trial designed to confirm the symptomatic effects of camicinal treatment vs. placebo, on gastroparesis symptoms in type 1 and 2 diabetic subjects with gastroparesis. The primary purpose of this study is to determine if a low-dose of camicinal (25 milligram\[mg\]) for 12 weeks of repeat administration improves gastroparesis symptoms as measured by the Gastrointestinal Cardinal Symptom Index - Daily Diary (GCSI-DD) in approximately 120 subjects with type 1 or 2 diabetes mellitus (DM) who have documented abnormally slow gastric emptying and have symptoms consistent with gastroparesis.

Subjects will be randomized in a 1:1 ratio to receive either camicinal or placebo. The study will consist of a screening/baseline period of up to 35 days, a 12 week treatment period, a 2-week post-treatment assessment of symptoms and a 14 day (+/- 2 days) post treatment safety follow-up visit.

Detailed description:

Arms: arm 1: Subjects will receive camicinal matching placebo orally once daily (QD) from Day 1 to Day 84 arm 2: Subjects will receive camicinal 25 mg orally QD from Day 1 to Day 84
Interventions: intervention 1: Placebo intervention 2: Camicinal
Intervention descriptions: intervention 1: Camicinal matching placebo is available as tablet to be taken orally with 100mL of water in the morning intervention 2: Camicinal is available as 25 mg tablet to be taken orally with 100mL of water in the morning

Protocol documents:
Clinical trial NCT01598311
Conditions: Clostridium Difficile Infection
Keywords: CDAD Clostridium difficile Associated Diarrhea CDI Clostridium difficile Infection Diarrhea
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2012-05-16; Completion date: 2015-08-25
Enrollment: 608 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A total of 608 participants with Clostridium Difficile Associated Diarrhea (CDAD) will participate in this study; participants will receive either oral vancomycin or CB-183,315 in a blinded fashion. Treatment will last for 10 days and participants will be followed up for at least 40 days and a maximum of 100 days. The purpose of this study is to evaluate how well CB-183,315 treats CDAD as compared to vancomycin.

Detailed description:

Arms: arm 1: Participants took CB-183,315 250 mg twice daily (b.i.d.) and placebo capsules b.i.d. by mouth for 10 days. arm 2: Participants took vancomycin 125 mg four times daily (q.i.d.) by mouth for 10 days.
Interventions: intervention 1: CB-183,315 intervention 2: Vancomycin intervention 3: Placebo
Intervention descriptions: intervention 1: CB-183,315 250 mg white coated tablet over-encapsulated in a size 00 opaque hard gelatin capsule. intervention 2: Vancomycin hydrochloride 125 mg capsule over-encapsulated in size 00 opaque hard gelatin capsule. intervention 3: Placebo size 00 opaque hard gelatin capsules.

Protocol documents:
Clinical trial NCT02503085
Conditions: Healthy Volunteer Study
Keywords: Ibuprofen
Sponsor: Reckitt Benckiser Healthcare (UK) Limited
Start date: 2015-06-02; Completion date: 2015-08-25
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to determine the rate and extent of absorption of Ibuprofen suspension formulations.

Detailed description:

Arms: arm 1: Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fasted condition arm 2: Nurofen for Children® suspension 400 mg/20 mL single-oral dose under fed condition arm 3: Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fasted condition arm 4: Algifor Dolo Junior® suspension 400 mg/20 mL single-oral dose under fed condition
Interventions: intervention 1: Nurofen for Children® intervention 2: Algifor Dolo Junior®
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01348269
Conditions: Bone Marrow Edema
Keywords: bone marrow edema Aclasta
Sponsor: Wuerzburg University Hospital
Start date: 2011-05-01; Completion date: 2015-08-26
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim is to test the reduction of bone marrow edema syndrome after a singular intravenous treatment with Zoledronic Acid within 6 weeks compared to placebo. The volume of the edema is defined as biometric data measured by the use of MRT before and six weeks after treatment. The hypothesis has to be checked whether Zoledronic Acid is efficient in the treatment of painful bone marrow edema. A statistically significant reduction of the edema in the MRT is considered as evidence for efficacy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aclasta intervention 2: Placebo
Intervention descriptions: intervention 1: 1 x intravenous non-current drip (infusion) intervention 2: NaCl Solution

Protocol documents:
Clinical trial NCT02103439
Conditions: Hepatitis Hepatitis C Hepatitis C/ Human Immunodeficiency Virus Coinfection
Keywords: Hepatitis C Cepeginterferon alfa Peginterferon Treatment
Sponsor: Biocad
Start date: 2013-06-06; Completion date: 2015-08-26
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to demonstrate the noninferiority of Algeron in combination with ribavirin compared to PegIntron in combination with ribavirin in treatment of chronic hepatitis C in Human Immunodeficiency Virus-1 infected patients

Detailed description:
The course of treatment in both groups shall be 12 weeks, and efficacy analysis, i.e. rate of rapid (after the 4th week) and early (after the 12th week) virologic response will be based on polymerase chain reaction data. For patients with treatment failure after the 12th week the antiviral therapy shall be discontinued. All patients who require further anti-viral treatment will receive a combination treatment with Algeron / PegIntron and ribavirin for another 36 weeks. Sustained virologic response will be assessed 24 weeks after last dose of study treatment.

Arms: arm 1: Algeron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight \<65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight \> 105 kg) arm 2: PegIntron at a dose of 1.5 µg/kg of body weight subcutaneously, once a week, and Rebetol, orally, at a daily dose of 800 mg (for body weight \<65 kg), 1,000 mg (for body weight 65 - 85 kg), 1,200 mg (for body weight 86 - 105 kg) or 1,400 mg (for body weight \> 105 kg).
Interventions: intervention 1: Algeron intervention 2: PegIntron
Intervention descriptions: intervention 1: 1.5 µg/kg of body weight subcutaneously, once a week intervention 2: 1.5 µg/kg of body weight subcutaneously, once a week

Protocol documents:
Clinical trial NCT01866930
Conditions: Chronic Hepatitis C Infection
Sponsor: Bristol-Myers Squibb
Start date: 2013-07-11; Completion date: 2015-08-27
Enrollment: 453 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate Sustained Virologic Response at post treatment Week 12 (SVR12)following treatment with Lambda/RBV/DCV in chronic HCV GT-1, -2, -3 or -4 subjects co-infected with HIV-1

Detailed description:
Study Classification: Safety/Efficacy and Pharmacokinetics/dynamics

GT=genotype

Arms: arm 1: Pegylated Interferon Lambda 180 µg solution, injection subcutaneously once weekly for 24 weeks

Ribasphere 200 mg tablets (800 mg per day: two 200 mg tablets in the morning and two 200 mg tablets in the evening) by mouth twice daily for 24 weeks

Daclatasvir 30 mg, 60 mg, or 90 mg tablets (depending on concomitant HIV regimen) once daily for 12 weeks arm 2: Pegylated Interferon Lambda 180 µg solution, injection subcutaneously once weekly for 24 or 48 weeks

Ribasphere 200 mg tablets, (1000 mg per day: two 200 mg tablets in the morning and three 200 mg tablets in the evening for subjects weighing \<75 kg and 1200 mg per day: three 200 mg tablets in morning and three 200 mg tablets in evening for subjects weighing ≥75 kg) by mouth twice daily for 24 or 48 weeks

Daclatasvir 30 mg, 60 mg, or 90 mg tablets (depending on concomitant HIV regimen) once daily for 12 weeks
Interventions: intervention 1: Pegylated Interferon Lambda-1a intervention 2: Daclatasvir (DCV) intervention 3: Ribasphere (RBV)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01532908
Conditions: Hepatitis C Infection
Keywords: Liver Transplantation
Sponsor: MassBiologics
Start date: 2012-11-21; Completion date: 2015-08-27
Enrollment: 11 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to assess efficacy of a human monoclonal antibody against Hepatitis C (MBL-HCV1) combined with telaprevir \[part 1: an HCV protease inhibitor\] or sofosbuvir \[part 2: an Hepatitis C virus NS5B polymerase inhibitor\] in a 56 day treatment duration in patients undergoing liver transplantation due to chronic HCV infection. There is an option for extended study treatment through 84 days if viral load is undetectable at day 56.

Detailed description:
Administration of Intravenous infusions of MBL-HCV1 (50mg/kg) human monoclonal antibody during the first 14 days post-transplantation: three infusions on day 0 (1-4 hours prior to the anhepatic phase, during the anhepatic phase, and 4-12 hours post-reperfusion). Daily infusions on days 1 through 7, weekly infusions on day 14 ± 2, day 21 ± 3, and day 28 ± 3, followed by biweekly infusions on day 42 ± 3 and on day 56 ± 3 if criteria for the stopping rule are not met. For those subjects electing extended treatment, the administration of additional infusions on day 70 ± 3 and day 84 ± 3 will be performed. Subjects receive an oral direct-acting antiviral (telaprevir in Part 1 and sofosbuvir in Part 2) starting no earlier than day 3 post-transplant and no later than day 7; dosing continuing through day 56 unless criteria for the stopping rule are met. Subjects who elect to receive extended study treatment for a total of 12 weeks continue telaprevir in Part 1 or sofosbuvir in Part 2 through day 84 ± 3.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MBL-HCV1 intervention 2: Telaprevir (Part 1) intervention 3: Sofosbuvir (Part 2)
Intervention descriptions: intervention 1: 50 mg/kg MBL-HCV1, intravenous, up to 15 infusions over 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 intervention 2: Two 375 mg tablets, 3 times a day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56 intervention 3: One 400 mg tablet, 1 time per day up to 56 days; option for extended treatment through 84 days if viral load undetectable at day 56

Protocol documents:
Clinical trial NCT01771627
Conditions: Tobacco Use Disorder
Sponsor: Roswell Park Cancer Institute
Start date: 2012-10-22; Completion date: 2015-08-28
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This pilot clinical trial studies varenicline or nicotine patch in promoting smoking cessation among current smokers. Varenicline or nicotine patch may help people stop smoking

Detailed description:
PRIMARY OBJECTIVES:

I. To determine if mail delivery of 12 weeks of varenicline results in improved smoking cessation outcomes relative to nicotine replacement therapy (NRT) in 300 smokers.

II. To determine if delivery of varenicline is cost-effective as compared to nicotine patch.

OUTLINE: Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients undergo general smoking cessation counseling and receive varenicline orally (PO) twice daily (QD) on days 1-28. Courses repeat every 28 days for up to 12 weeks.

ARM II: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.

After completion of study treatment, patients are followed up at 4 months.

Arms: arm 1: Patients undergo general smoking cessation counseling and receive varenicline PO QD on days 1-28. Courses repeat every 28 days for up to 12 weeks. arm 2: Patients undergo general smoking cessation counseling and receive nicotine patch continuously for 12 weeks.
Interventions: intervention 1: varenicline intervention 2: nicotine patch
Intervention descriptions: intervention 1: Given PO intervention 2: None

Protocol documents: