ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01060150
Conditions: Attention Deficit Disorder With Hyperactivity
Keywords: Attention Deficit Hyperactivity Disorder Methylphenidate hydrochloride Methylphenidate CONCERTA
Sponsor: Janssen Korea, Ltd., Korea
Start date: 2008-07-01; Completion date: 2010-04-01
Enrollment: 115 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy, tolerability and effects of Osmotic Release Oral System (OROS) methylphenidate hydrochloride (HCl) on learning skill changes in Korean participants with Attention-Deficit Hyperactivity Disorder (ADHD).

Detailed description:
This is 12 week, open label (all people involved know the identity of the intervention), prospective (study following participants forward in time), single arm, multicenter study (when more than one hospital or medical school team work on a medical research study) of OROS methylphenidate HCl. The study will consist of 6 visits at Screening, Baseline, Week 1, 3, 6 and 12. The participants already on other ADHD medications in addition to methylphenidate will be required to undergo a washout period (period when receiving no treatment) of at least 1 week. The participants will be on once daily study medication starting at 18 milligram per day (mg/day) in participants with less than 30 kilogram (kg) of body weight or at 27 mg/day in participants with more than 30 kg. The dose will be increased by 9 mg or 18 mg every week for up to Week 6 based on the treatment efficacy and tolerability, followed by a maximum maintenance dose of 72 mg orally once daily up to Week 12, during which the dose can be decreased by 9 mg depending on tolerability. Efficacy will primarily be assessed using Clinical Global Impression of Severity of Illness (CGI-S) scale, Clinical Global Impression of Improvement of Illness (CGI-I) scale, Korean version of ADHD-IV Rating Scale (K-ARS) and Learning Skill Test (LST) score. Participants' safety will be monitored.

Arms: arm 1: None
Interventions: intervention 1: OROS Methylphenidate HCl
Intervention descriptions: intervention 1: Osmotic Release Oral System (OROS) Methylphenidate HCl tablet will be given orally once daily at a starting dose of 18 milligram (mg) for those less than 30 kilogram (kg) of body weight and 27 mg for those more than or equal to 30 kg; the dose can be increased by 9 mg or 18 mg per week up to Week 6 depending on a participant's treatment effect and tolerability; then a maximum maintenance dose of 72 mg will be given orally once daily up to Week 12.

Protocol documents:
Clinical trial NCT01062269
Conditions: Healthy
Keywords: Bile acid sequestrant Resin Cholesterol Diabetes mellitus Lipids Glucose Bile Acid Sequestrant Acceptability Scale (BASA)validation study
Sponsor: Louisville Metabolic and Atherosclerosis Research Center
Start date: 2010-01-01; Completion date: 2010-04-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of the research study is (1) to rate the taste, texture, appearance, and mixability of 2 different doses of orange flavored cholestyramine compared to orange flavored Tang, (2) rank the importance of the taste, texture, appearance, and mixability when rating cholestyramine and Tang to determine the accuracy and usefulness of a taste test questionnaire.

Detailed description:
The primary objective of this study is to evaluate patient acceptability of 2 doses of orange-flavored generic Questran (cholestyramine) versus orange-flavored Tang Drink Mix (a commercial powdered orange drink without cholestyramine) via 2 BASA scales. A second objective is to assess the 2 different versions of the BASA scale. One version will be unweighted with the score based upon the aggregate score of each acceptability component. A second version will be weighted based upon subjectively-reported importance of the acceptability components. The one main study objective or focus is to determine which version of a BASA scale best differentiates patient acceptability of a bile acid sequestrant (cholestyramine) versus a placebo control powder (containing no bile acid sequestrant) thereby determining which BASA scale is the best validated instrument for future studies in assessing and comparing patient acceptability of bile acid sequestrants.

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Cholestyramine intervention 2: Cholestyramine intervention 3: Tang
Intervention descriptions: intervention 1: Cholestyramine 4 grams one time dose intervention 2: Cholestyramine 12 grams one dose, one day intervention 3: Tang one dose one day

Protocol documents:
Clinical trial NCT01068730
Conditions: Type 2 Diabetes Mellitus
Sponsor: AstraZeneca
Start date: 2010-02-01; Completion date: 2010-04-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To demonstrate the bioequivalence of 500 mg and 1000 mg Glucophage tablets manufactured by BMS relative to the respective strengths of 500 mg and 1000 mg Diabex tablets marketed in Australia by Alphapharm in the fed state

Detailed description:

Arms: arm 1: 500 mg metformin (Diabex): Single oral dose of 500 mg metformin (Diabex) tablet administered in the fed condition arm 2: 500 mg metformin (Glucophage™): Single oral dose of 500 mg metformin (Glucophage™) tablet administered in the fed condition arm 3: 1000 mg metformin (Diabex): Single oral dose of 1000 mg metformin (Diabex) tablet administered in the fed condition arm 4: 1000 mg metformin (Glucophage™): A Single oral dose of 1000 mg metformin (Glucophage™) tablet administered in the fed condition
Interventions: intervention 1: metformin (Diabex) intervention 2: metformin (Glucophage™) intervention 3: metformin (Glucophage™) intervention 4: metformin (Diabex)
Intervention descriptions: intervention 1: Tablets, Oral, 500 mg, Once daily, single dose intervention 2: Tablets, Oral, 500 mg, Once Daily, single dose intervention 3: Tablets, Oral, 1000 mg, Once daily, single dose intervention 4: Tablets, Oral, 1000 mg, Once daily, single dose

Protocol documents:
Clinical trial NCT01082380
Conditions: Healthy Volunteer
Keywords: radiolabeled healthy volunteers
Sponsor: Pfizer
Start date: 2010-03-01; Completion date: 2010-04-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The rationale for this study is to investigate the absorption, metabolism and excretion of \[14C\]PF 02341066 and characterize plasma, fecal and urinary radioactivity, and identify any metabolites, if possible, of \[14C\]PF 02341066 in humans.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PF-02341066
Intervention descriptions: intervention 1: oral suspension, single 250 mg dose of PF 02341066 containing approximately 100 µCi of \[14C\]PF 02341066

Protocol documents:
Clinical trial NCT01096017
Conditions: Asthma
Keywords: Terbutaline Turbuhaler Efficacy Asthma Japanese salbutamol Bricanyl
Sponsor: AstraZeneca
Start date: 2010-03-01; Completion date: 2010-04-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a single blind, single dose, crossover study to investigate the relative efficacy of terbutaline Turbuhaler® 0.4 mg in relation to salbutamol pressurized Metered Dose Inhaler (pMDI) 200 μg in Japanese adult asthmatic patients.The secondary objective of this study is to investigate safety of terbutaline Turbuhaler® 0.4 mg in Japanese adult asthma patients by means of adverse events (AEs) and vital signs (blood pressure, pulse rate). The subject population includes Japanese patients (16 years of age or older) with asthma who need treatment with inhaled Glucocorticosteroids (ICS).

Detailed description:

Arms: arm 1: Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI ⇒salbutamol pMDI 200 μg +placebo Turbuhaler® arm 2: salbutamol pMDI 200 μg +placebo Turbuhaler® ⇒Terbutaline Turbuhaler® 0.4mg + pMDI placebo pMDI
Interventions: intervention 1: Terbutaline Turbuhaler® intervention 2: Salbutamol pMDI intervention 3: pMDI placebo pMDI intervention 4: Placebo Turbuhaler®
Intervention descriptions: intervention 1: 0.4 mg, inhalation, single dose intervention 2: 200 μg, inhalation, single dose intervention 3: Placebo pMDI 2 inhalations intervention 4: Placebo Turbuhaler 1 inhalation

Protocol documents:
Clinical trial NCT01135069
Conditions: Acne
Sponsor: Spear Pharmaceuticals
Start date: 2009-10-01; Completion date: 2010-04-01
Enrollment: 480 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective will be to assess clinical bioequivalence of 0.1% Retin-A Micro® Gel and Spear Pharmaceutical's generic 0.1% Tretinoin Microsphere Gel with a placebo arm.

Detailed description:
Not required

Arms: arm 1: treatment of acne for 12 weeks arm 2: Treatment of acne for 12 weeks arm 3: Treatment if acne for 12 weeks as placebo
Interventions: intervention 1: Tretinoin microsphere 0.1% intervention 2: Brand Retin-A Micro tretinoin microsphere gel 0.1% intervention 3: placebo microsphere gel
Intervention descriptions: intervention 1: Treatment of acne vulgaris intervention 2: Treatment of acne vulgaris intervention 3: treatment of acne vulgaris

Protocol documents:
Clinical trial NCT01135498
Conditions: Colorectal Cancer
Sponsor: Hoffmann-La Roche
Start date: 2006-11-01; Completion date: 2010-04-01
Enrollment: 90 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of a first-line regimen of Avastin and Xelox (Xeloda + Eloxatin) followed by Avastin and Tarceva, in patients with metastatic colorectal cancer. Patients will receive 6 x 21 day cycles of treatment with Avastin (7.5mg/kg iv on day 1), Xeloda (1000mg/m2 po twice daily on days 1 to 14) and Eloxatin (130mg/m2 iv on day 1). Patients free of disease progression will then continue with Avastin (7.5mg/kg iv once every 3 weeks) and Tarceva (150mg po daily). The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: eloxatin intervention 3: capecitabine [Xeloda] intervention 4: erlotinib [Tarceva]
Intervention descriptions: intervention 1: Intravenous repeating dose intervention 2: Intravenous repeating dose intervention 3: Oral repeating dose intervention 4: Oral repeating dose

Protocol documents:
Clinical trial NCT01146860
Conditions: Acute Rhinosinusitis
Keywords: BNO 1016, acute rhinosinusitis
Sponsor: Bionorica SE
Start date: 2010-01-01; Completion date: 2010-04-01
Enrollment: 386 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the dry extract BNO 1016 is effective and safe in the treatment of acute rhinosinusitis in adults.

Detailed description:
The aim of this clinical study is to investigate the efficacy of a 15-days treatment with the herbal medicinal product BNO 1016 for therapy of acute rhinosinusitis in adult patients. Due to the considerable morbidity and the diminished quality of life experienced by people afflicted with acute rhinosinusitis an important aim of the treatment is to reduce the severity of rhinosinusitis symptoms and the duration of the disease. By grading the severity of the disease on the basis of the 5 main rhinosinusitis symptoms the investigator will assess the efficacy of the treatment.

Arms: arm 1: sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days arm 2: sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration: 15 days
Interventions: intervention 1: BNO 1016 intervention 2: Placebo
Intervention descriptions: intervention 1: sugar coated tablets with dry extract (80 mg) of 5 herbal drugs; dosage: 480 mg per day (2 tablets t.i.d.) duration: 15 days intervention 2: sugar coated tablets with identical appearance to active treatment; frequency: 2 tablets t.i.d. duration 15 days

Protocol documents:
Clinical trial NCT01150981
Conditions: Metabolic Syndrome Insulin Resistance
Sponsor: University of Massachusetts, Worcester
Start date: 2006-11-01; Completion date: 2010-04-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Insulin resistance is a common condition that can lead to type 2 diabetes. One of the commonly prescribed diabetes medications, called rosiglitazone, works by decreasing insulin resistance. Rosiglitazone appears to work on fat cells. Animal studies suggest that rosiglitazone may work by increasing blood vessel growth in fat cells. The purpose of this research is to see if rosiglitazone also increases blood vessel growth in human fat cells. The investigators will compare results from before and after being on rosiglitazone for 6 weeks.

Detailed description:
Adipocytes play a crucial role in the control of metabolic homeostasis, by sequestering excess calories in the form of triglycerides, and secreting cytokines that control systemic fuel utilization. Sustained excess calorie consumption results in adipocyte hypertrophy and hyperplasia, and like any expanding tissue, requires increased capillary expansion to nourish the enlarged adipose tissue mass. Recent reports indicate that decreased capillary density in adipose tissue of obese individuals correlates with insulin resistance, suggesting that an imbalance of angiogenesis and adipogenesis may underlie this condition. To determine whether improvement in insulin sensitivity is related to changes in adipose tissue capillary development, we conducted a randomized, double-blind, placebo-controlled trial to determine capillary density, angiogenic growth potential, and metabolic parameters in healthy human volunteers before and after treatment with rosiglitazone, a potent insulin sensitizer.

Arms: arm 1: One 8mg capsule daily for 6 weeks. arm 2: One capsule daily for 6 weeks.
Interventions: intervention 1: Rosiglitazone intervention 2: Placebo
Intervention descriptions: intervention 1: One 8mg capsule daily for 6 weeks. intervention 2: One capsule daily for 6 weeks.

Protocol documents:
Clinical trial NCT01170949
Conditions: Chronic Urticaria
Keywords: urticaria
Sponsor: Marcus Maurer
Start date: 2008-09-01; Completion date: 2010-04-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomised, double-blind, placebo-controlled study evaluating the effects of miltefosine on skin lesions in patients with treatment resistant chronic urticaria. Treatment resistance is defined by insufficient treatment response after a minimum of 1 week therapy with the maximum labelled dose of a non-sedating antihistamine. Eligible subjects will be enrolled at baseline 8 (+/- 1) days after screening. 75 Patients will be randomised in a 2:1 ratio to one of the following treatment groups as add-on to the ongoing therapy with a non-sedating antihistamine for treatment period of 4 weeks: 25 placebo and 50 active drug Efficacy and safety evaluations are done at baseline day 7, 14, 21 safety, only) and 28 (or end of treatment) and at day 56 (28 days after end of treatment).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Miltefosine intervention 2: Placebo
Intervention descriptions: intervention 1: 50 or 100 or 150mg per day intervention 2: Placebo

Protocol documents:
Clinical trial NCT01199965
Conditions: Healthy Subjects
Sponsor: Allergan
Start date: 2010-01-01; Completion date: 2010-04-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Compare the pharmacokinetics of Dihydroergotamine Mesylate (DHE) delivered by oral inhalation (MAP0004) or Intravenous (IV) DHE in smokers versus non-smokers.

Identify whether there are clinically significant differences in the tolerability of MAP0004 between smokers and non-smokers.

Detailed description:

Arms: arm 1: Smokers and non-smokers received Intravenous Dihydroergotamine Mesylate (IV DHE) at Visit 2 followed by MAP0004 7-11 days later at Visit 3. arm 2: Smokers and non-smokers received MAP0004 at Visit 2 followed by Intravenous Dihydroergotamine Mesylate (IV DHE) 7-11 days later at Visit 3.
Interventions: intervention 1: MAP0004 intervention 2: IV DHE
Intervention descriptions: intervention 1: 1.0mg MAP0004 via inhalation at Visit 2 or 3 as per protocol intervention 2: IV DHE administered at Visit 2 or 3 as per protocol

Protocol documents:
Clinical trial NCT01212302
Conditions: Coronary Artery Disease
Keywords: Clopidogrel ASA Low Response Resistance
Sponsor: Ruhr University of Bochum
Start date: 2008-10-01; Completion date: 2010-04-01
Enrollment: 500 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Dual antiplatelet therapy with acetylsalicylic acid (ASA, aspirin) and clopidogrel is of great importance for treatment following coronary stenting. Unfortunately the variable platelet inhibitory effectiveness compromises the antithrombotic benefit of dual antiplatelet therapy. The aim of this prospective single centre study was to reduce the low response incidence of dual antiplatelet therapy with ASA and clopidogrel based on a standardized therapy algorithm.

Detailed description:
Platelet function testing using whole blood aggregometry was performed 48 hours following coronary stenting (either acute coronary syndromes or stable coronary artery disease). The antiplatelet therapy included a loading dose of 600 mg clopidogrel and 500 mg ASA, followed by 75 mg clopidogrel and 100 mg ASA once daily. Clopidogrel low-response (CLR) and/or ASA (ASA low response) were treated according to a structured therapy plan.

Arms: arm 1: If the treatment with aspirin and/or clopidogrel is insufficient (platelet function testing) the dose was increased or the drug was changed (clopidogrel to ticlopidine or prasugrel)
Interventions: intervention 1: Optimizing ASA and clopidogrel treatment
Intervention descriptions: intervention 1: ASA 100 mg, ASA 300 mg, ASA 500 mg

Clopidogrel 75 mg, Clopidogrel 150 mg, Ticlopidine 2x 250 mg, Prasugrel 10 mg. Intervention List:

In the case of clopidogrel low-response, the maintenance dose was doubled (repeated loading dose followed by 150 mg daily), and when still ineffective ticlopidine or prasugrel, if available and not contraindicated, were used. ASA low-responders were treated by increasing the dose to 300 mg in a first step or to 500 mg ASA when the first modification was not sufficient.

Protocol documents:
Clinical trial NCT02716779
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2007-04-01; Completion date: 2010-04-01
Enrollment: 68 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examined the influence of ribavirin on the initial virological response in treatment-naïve participants with chronic hepatitis C, genotype 1. Participants were randomized to 1 of 3 treatment groups to receive placebo, ribavirin monotherapy 1000 milligrams (mg) to 1200 mg orally daily depending on body weight or pegylated interferon (PEG-IFN) alfa-2a (Pegasys®) 180 micrograms (mcg) subcutaneously (SC) weekly, for 6 weeks. Following the initial 6 weeks, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin (Copegus®) for 12 weeks. If there was an initial virological response after 12 weeks of combination therapy, treatment could be continued for a further 36 weeks outside of the study.

Detailed description:

Arms: arm 1: Participants with chronic hepatitis C, genotype 1, received pegylated interferon (PEG-IFN) alfa-2a monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks. arm 2: Participants with chronic hepatitis C, genotype 1, received ribavirin matching placebo for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks. arm 3: Participants with chronic hepatitis C, genotype 1, received ribavirin monotherapy for 6 weeks. Thereafter, all participants received combination therapy with PEG-IFN alfa-2a plus ribavirin for 12 weeks.
Interventions: intervention 1: Pegylated Interferon (PEG-IFN) alfa-2a intervention 2: Placebo intervention 3: Ribavirin
Intervention descriptions: intervention 1: Pegylated interferon (PEG-IFN) alfa-2a (40 kilodalton \[KD\]) 180 microgram (mcg) subcutaneously (SC) weekly, for 6 weeks during monotherapy and/or 12 weeks during combination therapy. intervention 2: Ribavirin matching placebo orally (PO) twice daily for 6 weeks. intervention 3: Ribavirin, 1000 mg orally (PO) (400 mg in the morning \[=2 tablets\] and 600 mg in the evening \[=3 tablets\]) in participants with a body weight less than 75 kilogram (kg) or 1200 mg PO (600 mg at each time =3 tablets, in the morning and evening, respectively) in participants with a body weight greater than or equal to 75 kg, PO daily for 6 weeks during monotherapy and/or 12 weeks during combination therapy.

Protocol documents:
Clinical trial NCT00762073
Conditions: Eosinophilic Esophagitis (EoE)
Keywords: eosinophilic esophagitis
Sponsor: Shire
Start date: 2009-01-08; Completion date: 2010-04-02
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, placebo-controlled, parallel-arm, dose-ranging study in subjects with eosinophilic esophagitis, 2-18 years of age. Eligible subjects will be randomized into one of four treatment groups. The Treatment Period will be 12 weeks during which subjects will visit the clinic at study weeks 0 (Baseline Visit), 2, 4, 8 and 12 (Final Treatment Evaluation) for clinical symptom assessment and safety evaluation (including adverse events and vital signs). All study treatments (active drug and placebo) will be administered orally twice daily during the Treatment Period, once in the morning after breakfast and once in the evening at bedtime.

Detailed description:

Arms: arm 1: None arm 2: Low Dose Group arm 3: Medium Dose Group arm 4: High Dose Group
Interventions: intervention 1: budesonide intervention 2: placebo
Intervention descriptions: intervention 1: oral suspension intervention 2: oral suspension matching budesonide

Protocol documents:
Clinical trial NCT00784693
Conditions: Endometriosis
Keywords: Endometriosis pain tanezumab nerve growth factor questionnaires
Sponsor: Pfizer
Start date: 2008-12-18; Completion date: 2010-04-05
Enrollment: 48 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether tanezumab is effective and safe in the treatment of pain associated with endometriosis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tanezumab intervention 2: Placebo
Intervention descriptions: intervention 1: 15 mg IV single dose intervention 2: Placebo IV single dose

Protocol documents: