ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01833065
Conditions: Chronic Idiopathic Constipation
Sponsor: Ferring Pharmaceuticals
Start date: 2013-04-01; Completion date: 2014-04-01
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
12 Week Efficacy and Safety Trial Followed by a 4 Week Withdrawal Period for Patients with Chronic Idiopathic Constipation.

Detailed description:
The present trial was designed to determine the efficacy and safety of elobixibat treatment (at both doses of 5 mg and 10 mg/day) compared to placebo treatment for 12-week Treatment Period followed by a 4-week Withdrawal Period in patients with chronic idiopathic constipation. During Withdrawal Period a sub-group of patients in elobixibat 5 mg and 10 mg treatment arms respectively received placebo treatment, while rest of the patients continued with 5 mg and 10 mg treatment in respective groups. In placebo groups, patients received elobixibat 10 mg treatment during Withdrawal Period. Patients were followed-up for 2 weeks after end of the Withdrawal Period.

The assessment of primary and key secondary end points was done for patients who completed the first 12 weeks of treatment period. Incidence of Adverse Events (AEs) were reported till 2 weeks after end of the Withdrawal Period.

The trial was early terminated due to a distribution issue with the trial medication.

Arms: arm 1: Elobixibat 10 mg/day arm 2: Elobixibat 5 mg/day arm 3: Placebo
Interventions: intervention 1: Elobixibat 10 mg/day intervention 2: Elobixibat 5 mg/day intervention 3: Placebo
Intervention descriptions: intervention 1: Elobixibat 10 mg/day intervention 2: Elobixibat 5 mg/day intervention 3: Placebo

Protocol documents:
Clinical trial NCT01835496
Conditions: Sickle Cell Disease
Keywords: sickle cell disease iron overload pharmacokinetics Ferriprox deferiprone
Sponsor: ApoPharma
Start date: 2013-05-01; Completion date: 2014-04-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The objective of this study is to evaluate the pharmacokinetics of deferiprone and its 3-O-glucuronide metabolite following administration of a single 1500 mg dose of Ferriprox in patients with sickle cell disease.

Detailed description:
This is a single-arm, single-dose study of Ferriprox in patients with sickle cell disease. Patients found to be eligible will visit the clinic the day before receiving the drug, in order to reconfirm eligibility and to undergo baseline assessments, and will receive a single dose of 1500 mg Ferriprox under fasting conditions. Blood and urine samples for pharmacokinetic assessment will be collected over a 10-hour period. Standard safety assessments will be performed throughout the study, and patients will return for a safety follow-up.

Arms: arm 1: single 1500 mg dose of Ferriprox
Interventions: intervention 1: single 1500 mg dose of Ferriprox
Intervention descriptions: intervention 1: A single dose of 1500mg of Ferriprox (three 500mg tablets) administered under fasting conditions

Protocol documents:
Clinical trial NCT01844700
Conditions: High Risk MC4R Genotype Low Risk MC4R Genotype One Week or Less Antipsychotic Lifetime Exposure
Keywords: MC4R genotype antipsychotic induced weight gain pediatric population
Sponsor: Northwell Health
Start date: 2013-07-01; Completion date: 2014-04-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We will conduct a 12-week, randomized open label study, comparing usual care (UC) antipsychotic treatment (aripiprazole, quetiapine, risperidone) with ziprasidone (ZIP) in children and adolescents aged 13-18 years old. Patients will have 10 days or less lifetime antipsychotic exposure and be in clinical need for antipsychotic treatment for a pediatric psychiatric disorder with FDA indication for antipsychotic use, i.e., bipolar mania, schizophrenia-spectrum disorders, and irritability associated with autistic disorder. In addition, we will also include youth fulfilling research diagnostic criteria for severe mood dysregulation (SMD). Randomization will be stratified by high vs. low genetic risk for antipsychotic-induced weight gain based on MC4R genotype and the primary outcome will be weight change from baseline to endpoint between ZIP and UC antipsychotic treatment in each of the two genotype groups. As detailed below, other metabolic and cardiac safety parameters will also be measured and compared across treatments in each of the genotype groups.

Detailed description:

Arms: arm 1: (20-160mg/d, bid) for 12 weeks arm 2: Aripiprazole (2-30mg/d), Quetiapine (25-800mg/d) or Risperidone (0.1-8mg/d) for 12 weeks
Interventions: intervention 1: Ziprasidone intervention 2: aripiprazole, quetiapine, or risperidone
Intervention descriptions: intervention 1: random assignment to ZIP (20-160mg/d, bid dosing) intervention 2: random assignement to Usual Care antipsychotic UC antipsychotic (aripiprazole 2-30mg/d, quetiapine 25-800mg/d or risperidone 0.1-8mg/d)

Protocol documents:
Clinical trial NCT01874340
Conditions: Multiple Sclerosis
Keywords: Multiple Sclerosis Relapsing Multiple Sclerosis AIN457 Secukinumab Magnetic Resonance Imaging Relapsing Remitting Multiple Sclerosis Autoimmune Diseases Nervous System Diseases Immune System Diseases Demyelinating Diseases
Sponsor: Novartis Pharmaceuticals
Start date: 2013-06-01; Completion date: 2014-04-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of AIN457 versus placebo in patients with relapsing multiple sclerosis.

Detailed description:

Arms: arm 1: AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 low dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis. arm 2: Matching placebo will be administered intravenously. Approximately 105 patients will be randomized to placebo (65 in Stage 1 and 40 in Stage 2). arm 3: AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 middle dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis arm 4: AIN457 will be administered intravenously. Approximately 65 patients will be randomized to AIN457 high dose in Stage 1. An additional 40 patients may be randomized to this group if it is one of the two selected dose groups to be expanded for Stage 2 following an Interim Analysis.
Interventions: intervention 1: Placebo intervention 2: AIN457
Intervention descriptions: intervention 1: Placebo will be administered at predefined visits over the 6-month treatment phase. intervention 2: AIN457 will be administered at predefined visits over the 6-month treatment phase.

Protocol documents:
Clinical trial NCT01880736
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2013-06-01; Completion date: 2014-04-01
Enrollment: 458 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia. The aim of the trial is to investigate the efficacy and safety of flexible versus fixed dosing and simple versus stepwise titration with OD insulin degludec in inadequately treated subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: insulin degludec intervention 2: insulin degludec intervention 3: insulin degludec
Intervention descriptions: intervention 1: Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD with the option to vary time of administration within a window of plus/minus 8 hours. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency. intervention 2: Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered under the skin OD at the same time each day. A maximum of 3 pre-trial OADs are allowed during the trial at an unchanged, stable dose level and dosing frequency. intervention 3: Individual dose adjusted once weekly. IDeg (100 U/mL, 3 mL FlexTouch® pen PDS290) to be administered subcutaneously (under the skin) OD at the same time each day. A maximum of 3 pre-trial oral anti-diabetic drugs (OADs) are allowed during the trial at an unchanged, stable dose level and dosing frequency.

Protocol documents:
Clinical trial NCT01899729
Conditions: Plaque Psoriasis
Keywords: plaque psoriasis autoimmune disease Toll like receptor
Sponsor: Idera Pharmaceuticals, Inc.
Start date: 2013-05-01; Completion date: 2014-04-01
Enrollment: 46 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
IMO 8400 is a second-generation oligonucleotide antagonist of endosomal Toll-like receptors (TLR) 7, TLR8 and TLR9. These TLR react to complexes of exogenous nucleic acids (as might be encountered during infection) and endogenous nucleic acids (as might be released during tissue damage during autoimmune disease). In vitro and in multiple animal models of autoimmune disease, IMO-8400 blocks immune activation mediated through TLR7, 8 and 9. In Phase 1 studies (Protocol 8400-001) IMO 8400 has been administered to healthy adults by SC injection at single-doses and multiple-doses (4 weeks) up to 0.6 mg/kg. All treatments were well-tolerated, with mild injection site reactions and no pattern of systemic reactions or laboratory changes.

The current study represents the first clinical trial of IMO-8400 in patients with active autoimmune disease. Moderate to severe plaque psoriasis was chosen for this 12-week proof of activity trial based on a prior 4-week study using a first generation TLR7 and 9 antagonist which demonstrated clinical improvement in this patient population.

Detailed description:
Eligible subjects will be enrolled and randomized to receive one of the four treatments (three dose levels of IMO-8400 or Saline Placebo). Treatments will be administered once weekly by subcutaneous injections. Subjects will received treatment for 12 weeks and then be followed for an additional 6 weeks to assess the durability of the response.

Arms: arm 1: IMO 8400 at 0.075 mg/kq q wk x 12 wks arm 2: IMO-8400 at 0.15 mg/kg q wk x 12 wks arm 3: IMO\_8400 at 0.3 mg/kg q wk x 12 wks arm 4: Saline (placebo) q wk x 12 wks arm 5: IMO\_8400 at 0.6 mg/kg q wk x 12 wks
Interventions: intervention 1: IMO-8400 Regimen 1 intervention 2: IMO-8400 Regimen 2 intervention 3: IMO-8400 Regimen 3 intervention 4: Saline Placebo intervention 5: IMO-8400 Regimen 4
Intervention descriptions: intervention 1: IMO-8400 0.075 mg/kg q wk x 12 wk by subcutaneous injection intervention 2: IMO-8400 0.15 mg/kg q wk x 12 wk by subcutaneous injection intervention 3: IMO-8400 0.3 mg/kg q wk x 12 wk by subcutaneous injection intervention 4: Saline q wk x 12 wk by subcutaneous injection intervention 5: IMO-8400 0.6 mg/kg q wk x 12 wk by subcutaneous injection

Protocol documents:
Clinical trial NCT01900847
Conditions: Acute Pain
Keywords: Ketamine Acute Pain
Sponsor: University of Arizona
Start date: 2013-06-01; Completion date: 2014-04-01
Enrollment: 17 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Our goal is to study whether giving people low dose ketamine along with morphine when they come to the Emergency Department will help their pain more than giving morphine by itself. There have been many studies showing that low dose ketamine is safe and effective for pain control. Ketamine is frequently used for pain control in ambulances and helicopters transporting injured patients to the hospital and has also been used for pain control in people who have just had surgery. The investigators would like to see if low dose ketamine would be safe and effective for patients with pain in the Emergency Department.

Patients are eligible for the study if they come to the Emergency Department and their treating physician decides to treat them with morphine (with certain exceptions such as pregnant patients and patients with eye injuries). They will be given information about participating in the study and if they agree, they will be given the study drug. The study drug will be either ketamine or salt water (saline). If patients continue to be in pain they will continue to receive doses of morphine just as they would if they were not in the study. If the treating physician feels that morphine alone is not enough, they will be free to choose another pain medication as they would normally.

Detailed description:

Arms: arm 1: Patient's will receive morphine during the usual course of their emergency department care and will receive a saline in a volume equivalent to the ketamine administered in the experimental arm of the stuy arm 2: Patient's will receive a 0.3mg/kg dose of ketamine in addition to morphine given in the usual course of emergency department care
Interventions: intervention 1: Ketamine intervention 2: Morphine intervention 3: placebo
Intervention descriptions: intervention 1: 0.3mg/kg ketamine intervention 2: Dosage of morphine determined by treating physician intervention 3: saline of same volume as appropriate weight based dose of ketamine

Protocol documents:
Clinical trial NCT01908842
Conditions: Opioid Dependence, on Agonist Therapy
Keywords: Opioid Dependence agonist buprenorphine naloxone BUP/NAL
Sponsor: Orexo AB
Start date: 2013-08-01; Completion date: 2014-04-01
Enrollment: 759 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess retention in treatment after induction with buprenorphine/naloxone (BNX) sublingual tablets compared with generic buprenorphine and after stabilization with BNX sublingual tablets compared with BNX film. Secondary objectives included assessment of treatment effects on opioid withdrawal symptoms, opioid cravings, and safety.

Detailed description:
This prospective, randomized, multicenter, parallel-group, non-inferiority study was conducted at 43 centers in the United States from August 2013 to April 2014. A non-inferior design was used because both products contain the same active components, and it was considered unethical to include a placebo arm. The study comprised an induction phase of 2 days and a stabilization phase of 20 days, with study visits scheduled on Days 1, 2, 3, 4, 8, 15, and 22. Eligible opioid-dependent patients were randomly assigned within 14 days of screening to induction with either the BNX sublingual tablets or generic buprenorphine tablets for 2 days. On Day 3, patients initially allocated to buprenorphine were switched to BNX film, whereas those allocated to BNX sublingual tablets continued on the same treatment. On Day 15, patients receiving BNX film were switched to BNX sublingual tablets, and those on BNX sublingual tablets were switched to BNX film. At the final study visit on Day 22, patients were offered the option of continuing in an open-label follow-up study of BNX sublingual tablets.

Arms: arm 1: Days 1-2: Generic buprenorphine sublingual tablets (blinded); Days 3 to 14: Buprenorphine/naloxone sublingual film (open-label); Days 15-21: BNX sublingual tablets (open-label); Day 22: Offered option in continuing in open-label follow-up study of BNX sublingual tablets arm 2: Days 1-2: BNX sublingual tablets (blinded); Days 3 to 14: BNX sublingual tablets (open-label); Days 15-21: Buprenorphine/naloxone sublingual film (open-label); Day 22: Offered option in continuing in open-label follow-up study of BNX sublingual tablets
Interventions: intervention 1: BNX sublingual tablets intervention 2: BNX sublingual film intervention 3: Buprenorphine
Intervention descriptions: intervention 1: Buprenorphine/naloxone sublingual tablets intervention 2: Buprenorphine/naloxone sublingual film intervention 3: Buprenorphine sublingual tablets

Protocol documents:
Clinical trial NCT01909336
Conditions: Hyponatremia
Sponsor: Instituto Tecnologico y de Estudios Superiores de Monterey
Start date: 2013-07-01; Completion date: 2014-04-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions.

Detailed description:
Multicenter, Randomized, Controlled clinical trial.

The purpose of this study is to determine if isotonic solutions reduce the risk of hospital acquired hyponatremia compared with hypotonic solutions

This study will include 150 patients in 2 groups according to these type of pathology: group 1: medical conditions which includes respiratory problems (pneumonia, bronchiolitis, acute asthma attack) and acute gastrointestinal problems (bacterial or viral gastroenteritis) and group 2: surgical conditions (pre, peri or postoperative patients will be included). Each group will be randomized to receive 3 types of interventions: 0.3% Saline (hypotonic solution), 0.45% Saline (hypotonic solution) or 0.9% Saline (isotonic solution). In non-dehydrated patients the daily total volume of liquid infused will be determined by the volumetric Holliday- Segar\* formula and the daily total volume will be calculated by adding the maintenance requirements (using the Holliday Segar formula) to the fluid deficit (according to percent of estimated weight\*\*) in dehydrated patients.

The glucose concentrations in the first group will be 3.3%, and in group 2 and 3 will be 5%. The potassium concentration will be 20mEq/L in all groups. Blood samples will be collected before, 8 hours and 24 hours after the start of intravenous fluid, for the analysis of sodium, potassium, glucose, urea and creatinine. The adverse clinical outcomes at 8 and 24 hours of the start of intravenous fluid will also be recorded. The sodium plasma level, the incidence of hyponatremia and the adverse clinical outcomes will be compared.

\*0-10 kilogram (kg): 100ml/kg per day; 10-20 kg: 1000 ml + 50 ml/kg/day over 10 kg; \>20 kg: 1500 ml + 20ml/ kg over 20kg

\*\* In patients under 10 kg correspond to a loss of 5% (50 mL/kg) in mild dehydration and 10% in moderate dehydration. In 10 kg or more: 3% (30 mL/kg) in mild dehydration and 6% (60 mL/kg) in moderate dehydration.

Arms: arm 1: Group 1: 0.3% Saline in 3.3% dextrose (intravenous) arm 2: Group 2: 0.45% Saline in 5% dextrose (intravenous) arm 3: Group 3: 0.9% Saline in 5% dextrose (intravenous)
Interventions: intervention 1: 0.3% Saline in 3.3% dextrose intervention 2: 0.45% Saline in 5% dextrose intervention 3: 0.9% Saline in 5% dextrose
Intervention descriptions: intervention 1: Hypotonic Solutions: 0.3% Saline in 3.3% dextrose intervention 2: Hypotonic Solutions: 0.45% Saline in 5% dextrose intervention 3: Isotonic Solutions 0.9% Saline in 5% dextrose

Protocol documents:
Clinical trial NCT01909466
Conditions: Schizophrenia Mental Disorder Nervous System Diseases
Keywords: OPC-14597 Aripiprazole Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2013-07-01; Completion date: 2014-04-01
Enrollment: 141 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia

Detailed description:
This is a trial designed to assess the safety and tolerability of multiple-dose administrations of aripiprazole intramuscular (IM) depot in the deltoid muscle in adult subjects with schizophrenia. The trial consists of a 113 day treatment period with a 28 day followup. The trial population will include male and female subjects between 18 and 64 years (inclusive), with a current diagnosis of schizophrenia as defined by DSM-IV-TR criteria and a prior history of tolerating aripiprazole per investigator's judgement.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Aripiprazole, OPC-14597
Intervention descriptions: intervention 1: 5 monthly applications of 400 mg of aripiprazole IM depot, where the first application is in the gluteal or deltoid muscle followed by 4 monthly administrations to the deltoid muscle

Protocol documents:
Clinical trial NCT01915173
Conditions: Gastroesophageal Reflux Disease (GERD) Heartburn Dyspepsia
Keywords: Gastroesophageal reflux disease (GERD) Heartburn Dyspepsia
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2013-06-01; Completion date: 2014-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to investigate the effects of a widely available over the counter supplement marketed for heartburn symptoms on symptoms and health-related quality of life in patients with gastroesophageal reflux disease (GERD). This study is designed as a pilot trial to assess safety and feasibility and to provide preliminary estimates of effect sizes.

Detailed description:

Arms: arm 1: Supplement, 2 tablets sublingually 3 times a day for 2 weeks. arm 2: Placebo, 2 tablets sublingually 3 times a day for 2 weeks. arm 3: Supplement, 2 tablets sublingually 3 times a day for 2 weeks. arm 4: Placebo, 2 tablets sublingually 3 times a day for 2 weeks.
Interventions: intervention 1: Supplement intervention 2: Placebo intervention 3: Expanded Interview intervention 4: Standard Interview
Intervention descriptions: intervention 1: Abies nigra 4C, Carbo vegetabilis 4C, Nux vomica 4C, and Robinia pseudoacacia 4C intervention 2: Lactose tablets intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01915732
Conditions: Acne Vulgaris
Sponsor: GlaxoSmithKline
Start date: 2013-04-01; Completion date: 2014-04-01
Enrollment: 1018 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicentre, randomized, assessor-blind, comparator-controlled evaluation of the efficacy, safety, and tolerability of Duac™Once Daily Gel and clindamycin phosphate gel in the topical treatment of mild to moderate facial acne vulgaris. A total of 1020 subjects will be enrolled, 510 per study arm. The subjects will be males and females between 12 and 45 years of age, inclusive, at the time of consent, who have mild to moderate facial acne vulgaris.

Subjects will use Duac™Once Daily Gel (once daily in the evening) or clindamycin phosphate gel twice daily (once in the morning and once in the evening) for 12 weeks. The subjects will be evaluated for change in lesion counts, investigator's static global assessment (ISGA), subject's global assessment (SGA), local tolerability and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit.

Detailed description:

Arms: arm 1: Subjects will use Duac™Once Daily Gel (once daily in the evening)for 12 weeks. The subjects will be evaluated for change in lesion counts, ISGA, SGA , local tolerability, and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit arm 2: Subjects will use 1% clinidamycin phosphate gel (twice daily in the morning and evening)for 12 weeks. The subjects will be evaluated for change in lesion counts, ISGA, SGA , local tolerability, and AEs/SAEs at Weeks0, 1, 2, 4, 8, and 12 (or at early withdrawal). In addition, quality of life measures will be performed at every study visit
Interventions: intervention 1: Duac™Once Daily Gel intervention 2: 1% clindamycin phosphate gel
Intervention descriptions: intervention 1: 1% clindamycin as clindamycin phosphate and 5% benzoyl peroxide intervention 2: 1% clindamycin as clindamycin phosphate

Protocol documents: