ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01483924
Conditions: Plaque Psoriasis
Keywords: Mild to Moderate Chronic Plaque Psoriasis
Sponsor: ApoPharma
Start date: 2011-11-01; Completion date: 2013-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics and efficacy of 12 weeks of treatment with Apo805K1 in subjects with moderate to severe chronic plaque psoriasis.

Detailed description:
A) To evaluate the safety and tolerability of 12 weeks of treatment with Apo805K1

B) To evaluate the pharmacokinetics of Apo805K1 following daily administration for 14 days

C) To evaluate the efficacy and pharmacodynamics of Apo805K1

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Apo805K1
Intervention descriptions: intervention 1: Sequential parallel dose escalation.

Protocol documents:
Clinical trial NCT01499303
Conditions: Diffuse Large B-Cell Lymphoma
Keywords: lymphoma DLBCL fostamatinib Diffuse Large B-Cell Lymphoma (DLBCL)
Sponsor: AstraZeneca
Start date: 2011-12-01; Completion date: 2013-10-01
Enrollment: 101 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the effectiveness of fostamatinib (200 mg twice a day) in patients with worsening or unmanageable lymphoma with a specific type of lymphoma called Diffuse Large B-Cell Lymphoma (abbreviated as DLBCL)

Detailed description:
Phase II Trial to Evaluate the Efficacy of Fostamatinib in Patients with Relapsed or Refractory Diffuse Large B-Cell Lymphoma (DLBCL)

Arms: arm 1: 200mg fostamatinib bid n=60
Interventions: intervention 1: Fostamatinib
Intervention descriptions: intervention 1: Phase II Trial to evaluate the efficacy of 200mg fostamatinib

Protocol documents:
Clinical trial NCT01519674
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-06-01; Completion date: 2013-10-01
Enrollment: 582 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe, Oceania and South America. The aim of this clinical trial is to generate data demonstrating how to intensify diabetes treatment using BIAsp 30 (biphasic insulin aspart 30) by adding or substituting BIAsp 30 to sitagliptin in various regimens for type 2 patients inadequately controlled on sitagliptin and metformin (with or without other oral anti-diabetic drugs (OADs)).

The trial is conducted as a phase 4 trial in the majority of the participating countries. However, in some countries the trial is conducted as phase 3b.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: biphasic insulin aspart 30 intervention 2: biphasic insulin aspart 30 intervention 3: sitagliptin intervention 4: metformin
Intervention descriptions: intervention 1: BIAsp 30 will be injected subcutaneously (under the skin) twice daily. Individually adjusted dose. intervention 2: BIAsp 30 will be injected subcutaneously (under the skin) once daily. Individually adjusted dose. intervention 3: Subjects will continue on their pre-trial sitagliptin treatment. intervention 4: Subjects will continue on their pre-trial metformin treatment.

Protocol documents:
Clinical trial NCT01534208
Conditions: Secondary Hypogonadism
Sponsor: Repros Therapeutics Inc.
Start date: 2012-05-01; Completion date: 2013-10-01
Enrollment: 499 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
ZA-300 is meant to determine the safety profile of Androxal (enclomiphene citrate) in men with secondary hypogonadism.

Detailed description:
This study is a phase III, open label safety study with a six month active dosing period. All subjects will be started at 12.5 mg Androxal and titrated to 25 mg if needed. Safety will be assessed by physical and visual acuity exams, slit lamp eye exams, clinical laboratory tests and adverse event reporting.

Arms: arm 1: Androxal 12.5 mg daily arm 2: Androxal 25 mg daily
Interventions: intervention 1: Androxal
Intervention descriptions: intervention 1: Androxal, oral, 12.5 mg capsule, taken once daily. Dose may be increased from 12.5 mg to 25 mg if indicated

Protocol documents:
Clinical trial NCT01536015
Conditions: Advanced Parkinson's Disease
Keywords: Rotigotine Neupro® Levodopa Gastrointestinal Dysfunction
Sponsor: UCB Pharma
Start date: 2012-01-01; Completion date: 2013-10-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose is to demonstrate superiority of Rotigotine over Placebo on motor symptoms when used in subjects with symptoms of Gastrointestinal Dysfunction. Hypothesis: Rotigotine will decrease OFF time compared to Placebo.

Detailed description:

Arms: arm 1: Rotigotine patch titrated from 4 mg/24 h - 8 mg/24 h or until effective or maximum dose is reached. arm 2: Placebo patch.
Interventions: intervention 1: Rotigotine intervention 2: Placebo
Intervention descriptions: intervention 1: Strength and Form: 4 - 8 mg patches, one patch applied every 24 hours

Dosage and Frequency: One patch every 24 hours

Duration: 10 weeks intervention 2: Frequency: One patch applied every 24 hours

Duration: 10 weeks

Protocol documents:
Clinical trial NCT01537042
Conditions: Restless Legs Syndrome End-Stage Renal Disease
Keywords: Rotigotine Neupro Restless Legs Syndrome RLS End-Stage Renal Disease
Sponsor: UCB BIOSCIENCES GmbH
Start date: 2012-04-01; Completion date: 2013-10-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a sleep laboratory study to evaluate the efficacy and safety of Rotigotine in subjects with Restless Legs Syndrome and End-Stage Renal Disease requiring hemodialysis.

The objectives are to demonstrate superiority of Rotigotine against Placebo as well as to investigate the effect of Rotigotine on quality of life and sleep.

Detailed description:

Arms: arm 1: Rotigotine Transdermal Patch

1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h. arm 2: Transdermal patch matched according to patch size and appearance.
Interventions: intervention 1: Rotigotine intervention 2: Placebo
Intervention descriptions: intervention 1: Transdermal patch; Dose: 1 mg/24 h, 2 mg/24 h or 3 mg/24 h once daily depending on optimal dose; maximal dose is 3 mg/24 h.

Subjects start with a Rotigotine dose of 1 mg/24 h for 1 week. The dose can be increased weekly during Up-Titration Period until either the optimal or the maximal dose of 3 mg/24 h has been reached. Subjects will maintain the optimal/maximal dose during the 2-week Maintenance Period. Following the Maintenance Period, subjects will be de-escalated from their optimal dose by decreasing the dose by 1 mg/24 h every other day during Taper Period until complete withdrawal. intervention 2: Transdermal patch; Patches matching to active treatment patches in size and appearance.

Up to 3 weeks of Titration,

2 weeks of Maintenance,

Up to 4 days of Taper Period.

Protocol documents:
Clinical trial NCT01548638
Conditions: Nicotine Addiction
Keywords: Tobacco Smoking Galantamine
Sponsor: University of Pennsylvania
Start date: 2012-02-01; Completion date: 2013-10-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a preliminary open-label study to determine whether a medication called galantamine (Brand Name: Razadyne) will help smokers quit and whether it reduces cognitive problems that smokers experience during a quit attempt.

Detailed description:
Galantamine, an FDA-approved treatment for Alzheimer's disease, is used to treat cognitive impairment by enhancing acetylcholine through inhibition of the enzyme, acetylcholinesterase. We propose an open-label pilot feasibility study of short-term (6 weeks) treatment with galantamine.

Sixteen chronic smokers will undergo a validated procedure for screening new medications. Following an initial 4-week drug run-up phase (8mg daily of galantamine-ER), medication dose will be increased to 16 mg daily of galantamine-ER during the fifth and sixth weeks of the study. At the beginning of Week 6, smokers will receive brief counseling and make a 7-day quit attempt.

Following completion of the study, participants will be offered standard smoking cessation treatment. Subjects will perform a working memory task (Visual/Spatial N-Back), a sustained attention task (Continuous Performance Task; CPT), a recall memory task (Word Recognition), a cognitive flexibility task (Wisconsin Card Sort Test), and a response inhibition task (Stop Signal Task). The primary outcome is the ability to remain abstinent during a 7-day quit attempt. Secondary outcomes include change in cognitive performance, adherence, and side effects.

This pilot study will provide information about the role of the cholinergic system during brief abstinence and whether enhancing acetylcholine reduces abstinence-induced cognitive symptoms that promote smoking relapse. Information obtained in this study may further establish cognitive performance measures as endophenotypes for nicotine dependence.

Arms: arm 1: The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease.
Interventions: intervention 1: Galantamine ER
Intervention descriptions: intervention 1: The study will be performed using the 8mg and 16mg doses of galantamine hydrobromide-ER, which is currently marketed for the treatment of Alzheimer's disease. The dosing regimen, which follows FDA-approved guidelines, will be an initial 4 weeks of drug run-up at the lowest 8mg daily dose, followed by an additional one week of drug run-up at the higher dose of 16mg daily.

Participants will continue to take the 16mg daily during the 7-day quit week, for a total of 6 weeks of treatment with galantamine-ER.

Protocol documents:
Clinical trial NCT01555164
Conditions: Type 2 Diabetes Mellitus
Sponsor: Gilead Sciences
Start date: 2012-06-01; Completion date: 2013-10-01
Enrollment: 442 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter study to determine the effect of ranolazine when added to metformin on glycemic control in adults with type 2 diabetes mellitus (T2DM) who are inadequately controlled despite current treatment with stable metformin therapy in addition to diet and exercise.

Detailed description:

Arms: arm 1: Qualifying Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening).

Treatment Period: Participants will receive ranolazine 500 mg + metformin 500 mg + placebo to match metformin twice daily on Days 1 through 7, followed by ranolazine 1000 mg + metformin 500 mg + placebo to match metformin twice daily from Day 8 through Week 24.

Participants are required to maintain their diet and exercise regimen. arm 2: Qualifying Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily for either 2 or 8 weeks (dependent on metformin dose and HbA1c level at Screening).

Treatment Period: Participants will receive metformin 1000 mg + placebo to match ranolazine twice daily through Week 24.

Participants are required to maintain their diet and exercise regimen.
Interventions: intervention 1: Ranolazine intervention 2: Placebo to match ranolazine intervention 3: Metformin intervention 4: Placebo to match metformin intervention 5: Diet intervention 6: Exercise
Intervention descriptions: intervention 1: Ranolazine tablet(s) administered orally intervention 2: Placebo to match ranolazine for the duration of the study intervention 3: Metformin tablet(s) administered orally once daily intervention 4: Placebo to match metformin for the duration of the study intervention 5: Participants are instructed to continue the diet regimen prescribed by their physician. intervention 6: Participants are instructed to continue the exercise regimen prescribed by their physician.

Protocol documents:
Clinical trial NCT01591655
Conditions: Cataract Inflammation Surgery
Sponsor: Bausch & Lomb Incorporated
Start date: 2012-07-01; Completion date: 2013-10-01
Enrollment: 360 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this clinical study is to compare the safety and efficacy of mapracorat ophthalmic suspension, 3% with its vehicle for the treatment of postoperative inflammation and pain following cataract surgery. Participants from the United States and Canada will be recruited for this study.

Detailed description:

Arms: arm 1: Mapracorat ophthalmic suspension, 3%, arm 2: The vehicle of the mapracorat ophthalmic suspension
Interventions: intervention 1: Mapracorat intervention 2: Vehicle
Intervention descriptions: intervention 1: 1 drop of study medication into the study eye four times daily (QID) for 14 days intervention 2: 1 drop of vehicle into the study eye QID for 14 days.

Protocol documents:
Clinical trial NCT01592747
Conditions: Autistic Disorder Autism Asperger's Disorder Asperger Syndrome Autism Spectrum Disorders Pervasive Developmental Disorder - Not Otherwise Specified (PDD-NOS)
Keywords: Asperger's Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS) Memantine Pediatric Disorder Randomized Controlled Trial
Sponsor: Forest Laboratories
Start date: 2012-09-01; Completion date: 2013-10-01
Enrollment: 479 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this randomized withdrawal study is to evaluate the safety, tolerability, and efficacy of memantine compared with placebo in pediatric patients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS).

Detailed description:
This clinical study was a 12-week, multicenter, double-blind, placebo-controlled, randomized withdrawal study in pediatric outpatients with autism, Asperger's Disorder, or Pervasive Developmental Disorder Not Otherwise Specified (PDD-NOS). Patients who completed at least 12 weeks of study drug exposure and met protocol specified responder criterion in lead in Study MEM-MD-91 (NCT01592786) at two consecutive visits separated by at least two weeks were eligible to transition to this study. The responder criterion was defined as having at least a 10 point improvement (reduction in score) in the Social Responsiveness Scale (SRS) total raw score relative to the Visit 1 total raw score in Study MEM-MD-91.

Weight based dose limits were selected in this study to ensure that exposure in terms of area under the curve (AUC) was less than the predefined limit of 2100 ng·h/mL which represents a 10-fold lower exposure than observed at the NOAEL(No observed adverse effect level) of 15 mg/kg/day in juvenile rats.

The weight-based dose limits in this study were as follows:

* Group A: ≥ 60 kg; maximum 15 mg/day
* Group B: 40-59 kg; maximum 9 mg/day
* Group C: 20-39 kg; maximum 6 mg/day
* Group D: \< 20 kg; maximum 3 mg/day

Arms: arm 1: Patients randomized to the full dose arm will continue taking memantine at the same tolerability and weight-based dose achieved in lead-in Study MEM-MD-91. Dosing will be once daily for up to 12 weeks. arm 2: Patients randomized to the reduced dose arm will take memantine at the tolerability and weight based dose that they received in lead in Study MEM-MD-91 reduced by at least 50%. Dosing will be once daily for up to 12 weeks. arm 3: Dosing will be once daily for up to 12 weeks.
Interventions: intervention 1: Memantine Hydrochloride (HCl) intervention 2: Memantine Hydrochloride (HCl) intervention 3: Placebo capsules
Intervention descriptions: intervention 1: Extended Release Dose ranging from 3-15mg/day; administered orally intervention 2: Extended Release Dose ranging from 3mg every other day to 6mg/day; administered orally. intervention 3: Once daily, oral administration.

Protocol documents:
Clinical trial NCT01613313
Conditions: Lipoma
Keywords: Lipoma Fatty Tumor
Sponsor: Zachary Gerut
Start date: 2012-05-01; Completion date: 2013-10-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research is to evaluate the safest and most effective dose of a Food and Drug Administration (FDA) approved drug (XIAFLEX) in the treatment of lipoma (fatty tumors of varying sizes that occur commonly in the adult population). The fat in the lipoma is like normal fat except that it is enclosed in a balloon-like structure which is made of collagen (fibrous tissue). Treatment of the lipoma with an injection of XIAFLEX (a protein that breaks down collagen fibers) may dissolve the collagen/fibrous strands thereby decreasing the size of the lipoma or removing it.

Detailed description:
Lipomas are common mesenchymal, benign, fatty tumors of varying sizes that occur in the general adult population. They usually present as painful or annoying lumps that are palpable and often visible in the subcutaneous tissue. Many subcutaneous lipomas are asymptomatic and are removed for non-medical reasons. However, they may cause the subject pain or discomfort or interfere with normal activity.

Spontaneous remission of lipomas has not been reported. A lipoma, once it presents itself, remains there for the lifetime of a person who carries it and may stay small or become larger. Alternative treatments of the lipoma are surgery or liposuction. If a large excision is performed there is the problem of having a very large scar and the accompanying issues of healing a large scar, or possible formation of a hematoma followed by consolidation of the hematoma and the remnants of a mass of scar tissue. This is often painful and more problematic than the original lipoma. liposuction also has the potential for hematoma formation followed by scar mass residual.

To avoid the complications listed above, a non-invasive method of treatment, such as enzyme mediated disassociation of adipose tissue, would be desirable. The primary aim of this study is to perform a step-wise approach in dosing to evaluate the safety and efficacy of clostridium histolyticum as a non-operative treatment for lipoma.

Arms: arm 1: single injection 0.058 mg Collagenase Clostridium Histolyticum arm 2: single injection 0.15 mg Collagenase Clostridium Histolyticum arm 3: single injection 0.29 mg Collagenase Clostridium Histolyticum arm 4: single injection 0.44 mg Collagenase Clostridium Histolyticum
Interventions: intervention 1: Collagenase Clostridium Histolyticum
Intervention descriptions: intervention 1: This is a dose escalation study in which subjects will sequentially receive single injections of 0.058 mg, 0.15 mg, 0.29 mg, 0.44 mg.

Protocol documents:
Clinical trial NCT01614457
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2012-07-01; Completion date: 2013-10-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have the R117H-CFTR mutation.

Detailed description:
Ivacaftor is the first CFTR modulator to show an improvement in CFTR function and clinical benefit in subjects with CF. Results from Phase 3 studies (VX08-770-102 \[Study 102\] \[NCT00909532\] and VX08-770-103 \[Study 103\] \[NCT00909727\]) showed that ivacaftor is effective in the treatment of subjects with CF who have the G551D-CFTR mutation, as evidenced by sustained improvements in CFTR channel function (measured by reduction in sweat chloride concentration) and corresponding substantial, durable improvements in lung function, pulmonary exacerbations, respiratory symptoms, and weight gain. Ivacaftor was also well tolerated, as evidenced by the rates and reasons for premature discontinuation and results of safety assessments.

Ivacaftor (Trade Name Kalydeco; 150 mg tablets) was initially approved in the United States for the treatment of CF in subjects 6 years of age and older who have a G551D mutation in the CFTR gene.

Arms: arm 1: Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks. arm 2: Placebo matched to Ivacaftor tablet orally twice daily for 24 weeks.
Interventions: intervention 1: Ivacaftor intervention 2: Placebo
Intervention descriptions: intervention 1: Ivacaftor 150 milligram (mg) tablet orally twice daily for 24 weeks. intervention 2: Placebo matched to Ivacaftor tablet orally twice daily for 24 weeks.

Protocol documents:
Clinical trial NCT01614470
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2012-07-01; Completion date: 2013-10-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of ivacaftor in subjects with cystic fibrosis (CF) who have a non-G551D cystic fibrosis transmembrane regulator (CFTR) gating mutation (any one of the following CFTR mutations: G178R, G551S, S549N, S549R, G970R, G1244E, S1251N, S1255P, or G1349D).

Detailed description:
Ivacaftor is the first CFTR modulator to show an improvement in CFTR function and clinical benefit in subjects with CF. Results from Phase 3 studies (VX08-770-102 \[Study 102\] \[NCT00909532\] and VX08-770-103 \[Study 103\] \[NCT00909727\]) showed that ivacaftor is effective in the treatment of subjects with CF who have the G551D-CFTR mutation, as evidenced by sustained improvements in CFTR channel function (measured by reduction in sweat chloride concentration) and corresponding substantial, durable improvements in lung function, pulmonary exacerbations, respiratory symptoms, and weight gain. Ivacaftor was also well tolerated, as evidenced by the rates and reasons for premature discontinuation and results of safety assessments.

Ivacaftor (Trade Name Kalydeco; 150 mg tablets) was initially approved in the United States for the treatment of CF in subjects 6 years of age and older who have a G551D mutation in the CFTR gene.

Arms: arm 1: Ivacaftor 150 milligram (mg) tablet orally twice daily for 8 weeks in treatment period 1 followed by placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period. arm 2: Placebo matched to ivacaftor tablet orally twice daily for 8 weeks in treatment period 1 followed by ivacaftor 150 mg tablet orally twice daily for 8 weeks in treatment period 2. Washout out period of 4 to 8 weeks was maintained between each treatment period. arm 3: Ivacaftor 150 mg tablet orally twice daily for 16 weeks.
Interventions: intervention 1: Ivacaftor intervention 2: Placebo
Intervention descriptions: intervention 1: 150 mg tablet, oral use, administered twice a day (q12h) intervention 2: oral use, administered twice a day (q12h)

Protocol documents:
Clinical trial NCT01617434
Conditions: Diabetes Diabetes Mellitus, Type 2
Sponsor: Novo Nordisk A/S
Start date: 2012-09-01; Completion date: 2013-10-01
Enrollment: 451 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Asia, Europe and North and South America. The aim of the trial is to investigate the effect of liraglutide versus placebo when added to basal insulin analogues with or without metformin in subjects with type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: liraglutide intervention 2: placebo
Intervention descriptions: intervention 1: Maximum 1.8 mg administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin. intervention 2: Placebo administered s.c. (subcutaneously, under the skin) once daily in addition to the subject's stable pre-trial basal insulin analogue regimen plus/minus metformin.

Protocol documents: