ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01764945
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-01-01; Completion date: 2013-03-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of the current study is to investigate the relative bioavailability of two different doses of BI 201335, administered as soft gelatine capsule in comparison to the equivalent doses of three different oral solution per dose of BI 201335.

Detailed description:

Arms: arm 1: low dose arm 2: high dose
Interventions: intervention 1: BI 201335 (Reference) intervention 2: BI 201335 (Test) intervention 3: BI 201335 (Test) intervention 4: BI 201335 (Test) intervention 5: BI 201335 (Reference) intervention 6: BI 201335 (Test) intervention 7: BI 201335 (Test) intervention 8: BI 201335 (Test)
Intervention descriptions: intervention 1: soft gelatine capsule, oral administration intervention 2: oral solution 3 intervention 3: oral solution 3 intervention 4: oral solution 2 intervention 5: soft gelatine capsule, oral administration intervention 6: oral solution 1 intervention 7: oral solution 1 intervention 8: oral solution 2

Protocol documents:
Clinical trial NCT01766310
Conditions: Hyperhomocysteinemia Obesity
Keywords: Folic acid Folate Homocysteine Obese Children
Sponsor: Queen Sirikit National Institute of Child Health
Start date: 2012-12-01; Completion date: 2013-03-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the present study was to determine whether folic acid supplementation could reduce plasma homocysteine in obese children and to determine the association between dietary folate, serum folate and homocysteine level through the randomized double blinded placebo controlled trial.

Detailed description:
Atherosclerosis is common \& remains a significant clinical problem because of leading to myocardial infarction, stroke and cardiovascular death. Many studies founded hyperhomocysteinemia is an independent risk factor for those cardiovascular diseases which take responsible for about 10% of total cardiovascular disease risk. Reduction of elevated plasma homocysteine may prevent up to 25% of cardiovascular events. One of modifiable cause of hyperhomocysteinemia is prevention of vitamin deficiency, especially folate deficiency.

Obese Thai children are probable risk for folate deficiency due to low dietary folate intake and low serum folate level from unbalanced diet (low vegetables intake \& high fat diet) and high prevalence of thalassemia. Moreover obese children are also at risk of atherosclerosis. However, no data have been reported about effect of folic acid supplementation on homocysteine level in these patients.

Arms: arm 1: placebo tablet in the same appearance and taste with folic acid orally once a day for 8 weeks of the study arm 2: Folic acid tablet 5mg per day orally (5mg/tablet) once a day for 8 weeks of the study
Interventions: intervention 1: Folic Acid intervention 2: placebo
Intervention descriptions: intervention 1: yellow tablet contained 5mg of folic acid, manufactured from the Government Pharmaceutical Organization, Ministry of Public Health, Thailand intervention 2: sugar tablet manufactured to mimic folic acid tablet

Protocol documents:
Clinical trial NCT01770392
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-01-01; Completion date: 2013-03-01
Enrollment: 26 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the effect of the P-gp inducer rifampicin on the pharmacokinetic parameters of nintedanib

Detailed description:

Arms: arm 1: multiple doses of Rifampicin + single dose of Nintedanib arm 2: single dose of Nintedanib
Interventions: intervention 1: Nintedanib intervention 2: Rifampicin intervention 3: Nintedanib
Intervention descriptions: intervention 1: single dose administration intervention 2: single dose once daily for 7 days intervention 3: single dose administration

Protocol documents:
Clinical trial NCT01770483
Conditions: Hepatitis C, Chronic DIABETES MELLITUS Type 2
Keywords: Nitazoxanide, Sustained viral response Type 2 DIABETICS
Sponsor: Services Institute of Medical Sciences, Pakistan
Start date: 2011-07-01; Completion date: 2013-03-01
Enrollment: 66 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate if nitazoxanide used in combination with interferon alfa and ribavirin is effective in treating Hepatitis c infected type 2 Diabetic patients by improving their sustained viral response by more than 80%.Considering that the study is being conducted in a third world country like Pakistan, the standard treatment of hepatitis C is not cost effective. The aim is to introduce a new treatment comparable in efficacy to peginterferon and also cost effective.

Detailed description:
After taking proper informed consent from patients, patients who fulfill the research criteria are randomized into 2 groups (control/study). Patients in both groups will be treated with conventional interferon alfa and Ribavirin.Those in study group will be given tab nitazoxanide 500mg twice daily in addition to conventional treatment. The patients will be followed up at regular intervals: 0,4,12,24,48 week.At each visit Hepatitis C Virus(PCR)RNA, Liver function tests, complete blood count will be done.

Arms: arm 1: Tablet Nitazoxanide 500mg twice daily will be added to the injection conventional interferon alfa 3 Million International Units alternate days and capsule Ribavirin 400mg-1200mg weekly for six months arm 2: Injection conventional interferon alfa 3 Million International Units alternate days and capsule ribavirin 400mg-1200mg weekly for six months
Interventions: intervention 1: nitazoxanide intervention 2: conventional interferon alfa intervention 3: Ribavirin
Intervention descriptions: intervention 1: nitazoxanide 500mg twice daily intervention 2: Inj interferon 3 Million International Units thrice weekly intervention 3: ribazole

Protocol documents:
Clinical trial NCT01785160
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-02-01; Completion date: 2013-03-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this trial is to investigate effect of faldaprevir on steady state pharmacokinetics of raltegravir.

The assessment of safety and tolerability will be an additional objective of this trial.

Detailed description:

Arms: arm 1: coated tablets, oral administration with 240 ml water arm 2: coated tablets and soft gelatine capsule, oral administration with 240 ml water
Interventions: intervention 1: Raltegravir intervention 2: Raltegravir intervention 3: Faldaprevir
Intervention descriptions: intervention 1: low dose oral administration intervention 2: low dose oral administration intervention 3: medium dose oral administration

Protocol documents:
Clinical trial NCT01786707
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 Diabetes Mellitus Hyperbaric oxygen therapy (HOT) Autologous Bone Marrow-Derived Buffy Coat Stem cells (SC)
Sponsor: Rodolfo Alejandro
Start date: 2009-07-01; Completion date: 2013-03-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A prospective, open labeled, randomized controlled clinical trial comparing the benefit of both hyperbaric oxygen therapy and intrapancreatic stem cell infusion to standard medical treatment alone for type 2 diabetes mellitus. Subjects will receive standard medical treatment (SMT) with insulin and metformin for 4 months (evaluation phase). Then they will be randomized into either the intervention group or the control group:

Detailed description:
This is a phase I/II, prospective, randomized case controlled study in patients with Type 2 Diabetes Mellitus (T2DM) that seeks to investigate whether the combination of intrapancreatic Autologous Stem Cell infusion (ASC) and Hyperbaric Oxygen treatment (HBO) can improve glycemic control and pancreatic function in T2DM patients compared to controls receiving standard medical treatment (SMT) with metformin and insulin alone.

New therapies that lead to stopping ß-cell damage and possible ß-cell regeneration may decrease the incidence and progression of T2DM chronic complications and together with achievable life style changes may improve general health and quality of life of T2DM patients. Preliminary data from a pilot study involving 25 subjects with T2DM that underwent a combined treatment using ASC+HBO showed a significant progressive and consistent reduction in plasma glucose and HbA1c with an increase in C-peptide in conjunction with a decrease in the number and dose of oral agents and/or insulin. These encouraging preliminary results require confirmation in a controlled, randomized prospective trial.

Arms: arm 1: Autologous stem cells and hyperbaric oxygen therapy arm 2: Patients in a control group will continue with standard medical treatment (Insulin and Metformin)
Interventions: intervention 1: Autologous stem cells intervention 2: Hyperbaric oxygen therapy intervention 3: Insulin intervention 4: Metformin
Intervention descriptions: intervention 1: Pancreatic artery infusion of Autologous Stem cells. intervention 2: None intervention 3: Insulin dose as per clinical management intervention 4: Metformin dose as tolerated

Protocol documents:
Clinical trial NCT01791413
Conditions: Endometriosis
Sponsor: Mahidol University
Start date: 2012-03-01; Completion date: 2013-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the ovarian reserve changes after preoperative depot medroxyprogesterone acetate (DMPA) in women with ovarian endometrioma undergoing laparoscopic cystectomy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: depot medroxyprogesterone acetate
Intervention descriptions: intervention 1: DMPA 150 mg intramuscular Before surgery 3 months (plus or minus 2 weeks)

Protocol documents:
Clinical trial NCT01795937
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-02-01; Completion date: 2013-03-01
Enrollment: 51 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
To investigate the effect of steady-state itraconazole on the pharmacokinetics of steady-state of faldaprevir and the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of atorvastatin as well as the effect of steady-state of faldaprevir on the single-dose pharmacokinetics of rosuvastatin

Detailed description:

Arms: arm 1: Interaction of Faldaprevir and Itraconazole arm 2: Interaction of Faldaprevir, Rosuvastatin and Atorvastatin
Interventions: intervention 1: Itraconazole intervention 2: Atorvastatin intervention 3: Faldaprevir intervention 4: Rosuvastatin intervention 5: Faldaprevir
Intervention descriptions: intervention 1: twice daily intervention 2: single dose intervention 3: once daily intervention 4: single dose intervention 5: once daily

Protocol documents:
Clinical trial NCT01807624
Conditions: Anesthesia
Keywords: Pharmacokinetic
Sponsor: St. Renatus, LLC
Start date: 2013-03-01; Completion date: 2013-03-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the pharmacokinetics/pharmacodynamics and safety of a nasal spray containing the anesthetic drug tetracaine in combination with oxymetazoline with blood draws over 24 hours.

Detailed description:
The purpose of this study is to determine the pharmacokinetics and safety of tetracaine, para- butylaminobenzoic acid (PBBA), and oxymetazoline after intranasal administration of the highest Phase 3 dose of Kovacaine Mist (Tetracaine Hydrochloride with Oxymetazoline Hydrochloride) to healthy volunteers.

This is an open-label, single-treatment, single-dose study in healthy volunteers in which all subjects will receive the highest Phase 3 dose of Kovacaine Mist on one occasion. No randomization is necessary for this single treatment, single dose study. A single study center will participate.

Each subject will receive a single dose of Kovacaine Mist (3% tetracaine HCl with 0.05% oxymetazoline HCl) consisting of 3 sprays (each 0.2 mL) in one nostril not taking longer than 8 minutes, for a total 0.6 mL dose containing 18 mg tetracaine HCl and 0.3 mg oxymetazoline HCl.

The total dosing period will be 8 minutes. Subjects will be required to fast 10 hours prior to dosing and for four (4) hours after dosing. Water will be allowed ad lib during the study except for one (1) hour prior through one (1) hour after dose administration. Subjects will be admitted to the study unit no later than 2100 hours of the evening prior to drug administration and will remain in the unit until the 24 hour blood sample is collected and discharge procedures are completed.

Arms: arm 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05% - 3 sprays will be administered at the start of the procedure
Interventions: intervention 1: Tetracaine HCl 3% and Oxymetazoline HCl 0.05%
Intervention descriptions: intervention 1: 1 spray is 0.2mL is volume and contains 6mg Tetracaine HCl 3% and 0.1mg Oxymetazoline HCl (para-butylaminobenzoic acid or PABA is active metabolite)

Protocol documents:
Clinical trial NCT01849419
Conditions: Drug Addiction
Sponsor: University of Chicago
Start date: 2010-07-01; Completion date: 2013-03-01
Enrollment: 65 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The main aim of the study is to investigate the effects of ±3,4-methylenedioxymethamphetamine (MDMA; ecstasy) on social and emotional processing in healthy humans. Ecstasy is a widely used recreational drug, with over 2 million Americans reporting use of the drug in 2006. With this number of users, and evidence that high doses of MDMA are neurotoxic in laboratory animals, the public health implications of ecstasy use may be substantial. Certain subjective effects of this drug distinguish it from other stimulants, and may contribute to its widespread use: That is, users report that ecstasy produces profound feelings of empathy and closeness to others. These so-called 'empathogenic' effects, which may reflect the distinctive neurochemical profile of action of the drug, have yet to be characterized in controlled laboratory studies. The investigators propose to characterize the effects of MDMA on measures of social and emotional processing that may contribute to this 'empathogenic' profile, including measures of emotion recognition, emotional responsiveness and sociability. The investigators will assess effects of MDMA (0, 0.75 and 1.5 mg/kg up to 125 mg) one active control drug (oxytocin: 20 IU) in 100 volunteers who report some prior ecstasy use. Oxytocin will be used because it appears to produce pro-social behavioral effects resembling those attributed to MDMA.

Detailed description:

Arms: arm 1: Healthy volunteers received all drug conditions (MDMA, oxytocin, and placebo) using a within-subjects design.
Interventions: intervention 1: Within-subjects (MDMA) intervention 2: Within-subjects (oxytocin) intervention 3: Within-subjects (placebo)
Intervention descriptions: intervention 1: This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received a single dose of MDMA (0.75, 1.5 mg/kg) on two session, oxytocin (20 IU) as an active control on one session (see second Intervention), and placebo one session (see third intervention). intervention 2: This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received oxytocin (20 IU) on one session, MDMA on two sessions (see first Intervention), and placebo on one session (see third Intervention). intervention 3: This was a within-subjects, double-blind, double-dummy, placebo-controlled experiment during which each participant received placebo on one session, MDMA on two sessions (see first Intervention), and oxytocin (20 IU) on one session (see second Intervention).

Protocol documents:
Clinical trial NCT01918332
Conditions: Hypertension, Hyperlipidemia
Sponsor: LG Life Sciences
Start date: 2012-04-01; Completion date: 2013-03-01
Enrollment: 168 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
This study aims to evaluate the efficacy and safety of the coadministration of valsartan (Diovan®) 160mg and rosuvastatin (Crestor®) 20mg in comparison to each component administered alone in patients with hypertension and hyperlipidemia.

Detailed description:

Arms: arm 1: Both Valsartan 160mg and Rosuvastatin 20mg are administered daily by mouth once a day for 8 weeks. arm 2: Intervention : Drug : Both Valsartan 160mg and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks. arm 3: Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg are administered daily by p.o. once a day for 8 weeks. arm 4: Intervention : Drug : Both Valsartan 160mg placebo and Rosuvastatin 20mg placebo are administered daily by p.o. once a day for 8 weeks.
Interventions: intervention 1: Valsartan 160mg intervention 2: Rosuvastatin 20mg intervention 3: Valsartan 160mg placebo intervention 4: Rosuvastatin 20mg placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01996748
Conditions: Otic Eczema
Sponsor: Salvat
Start date: 2012-02-01; Completion date: 2013-03-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of DF277 for the treatment of otic eczema.

Detailed description:

Arms: arm 1: Two administrations daily for 7 days arm 2: Two administrations daily for 7 days
Interventions: intervention 1: DF277 intervention 2: Placebo
Intervention descriptions: intervention 1: Two administrations daily for 7 days intervention 2: Two administrations daily for 7 days

Protocol documents:
Clinical trial NCT02453581
Conditions: Malaria
Sponsor: Medicines for Malaria Venture
Start date: 2012-09-01; Completion date: 2013-03-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A single centre, open, controlled study using Blood Stage Plasmodium falciparum challenge inoculum (BSPC) as a model to assess the effectiveness of three dose levels of the experimental anti-malarial product, OZ439.

Detailed description:
This was a single center study using blood stage Plasmodium falciparum challenge inoculum to characterize the effectiveness of OZ439 against early blood stage Plasmodium Falciparum infection.

The study was conducted in three cohorts (n=8) using different doses of OZ439. Dose escalation took place after review of the observed OZ439 safety and pharmacodynamic outcome for the previous cohort by the Safety Review Team.

Single doses of 100 mg, 200 mg and 500 mg were administered orally to participants in Cohort 1, Cohort 2 and Cohort 3 respectively.

Arms: arm 1: OZ439 100mg Powder for Oral Suspension arm 2: OZ439 200mg Powder for Oral Suspension arm 3: OZ439 500mg Powder for Oral Suspension
Interventions: intervention 1: OZ439
Intervention descriptions: intervention 1: OZ439 Powder for Oral Suspension

Protocol documents:
Clinical trial NCT02478281
Conditions: Methemoglobinemia Congenital Methemoglobinemia
Sponsor: American Regent, Inc.
Start date: 2012-10-01; Completion date: 2013-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Phase 1 trial to assess the single-dose safety, tolerability, and pharmacokinetic (PK) of Methylene Blue Injection, USP 1 mg/kg in healthy adult volunteers.

Detailed description:
This is an open-label, single-center, one-arm, safety, tolerability, and PK study in healthy male and female volunteers of Methylene Blue Injection, USP. Following an overnight fast, twelve healthy adult male and female volunteers will receive a single dose of study drug at a dose of 1 mg/kg solution per kg given intravenously over a period of 5 minutes followed by serial venous blood sampling at 0.042, 0.083, 0.167, 0.25, 0.5, 0.75, 1, 2, 3, 4, 6, 8, 10, 16, 36, 48, and 72 hours postdose.

Arms: arm 1: Single dose of Methylene Blue Injection, USP at a dose of 1 mg/kg solution per kg given intravenously over a period of approximately 5 minutes.
Interventions: intervention 1: Methylene Blue
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT06922643
Conditions: Chronic Hepatitis C
Sponsor: Nanogen Pharmaceutical Biotechnology Joint Stock Company
Start date: 2011-03-01; Completion date: 2013-03-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study presents a clinical study on the efficacy and safety of Pegnano combined with Barivir (Ribavirin) in treating treatment-naïve patients with Chronic Hepatitis C at Kien Giang General Hospital. The study aims to provide affordable treatment options while evaluating the virological response and side effects associated with the therapy

Detailed description:
This study evaluates the efficacy and safety of Pegnano (Peginterferon alfa-2a) combined with Barivir (Ribavirin) in treatment-naïve patients with chronic hepatitis C (HCV). Conducted at Kien Giang General Hospital from March 2011 to March 2013, this uncontrolled clinical trial enrolled 100 outpatients aged 18-65 with HCV RNA \>80 IU/mL and compensated liver disease. Patients received Pegnano (180 mcg, subcutaneous, weekly) and Barivir (15 mg/kg daily, oral) for 24 weeks (genotypes 2, 3) or 48 weeks (genotypes 1, 4, 5, 6), with possible extension to 72 weeks for genotype 1 with late virological response. The primary goal is to assess virological responses (rapid, early, end-of-treatment, and sustained at 24 weeks) by genotype and IL28B rs12979860 polymorphism, alongside safety through adverse event monitoring. Efficacy is measured via HCV RNA levels using real-time PCR, while safety is evaluated through clinical and paraclinical assessments every 4 weeks. The study aims to provide evidence for affordable HCV treatment options in Vietnam using locally produced drugs

Arms: arm 1: None
Interventions: intervention 1: Peginterferon Alfa-2A intervention 2: Ribavirin Oral Product
Intervention descriptions: intervention 1: 180 mcg, subcutaneous injection, once weekly intervention 2: 15 mg/kg daily, oral (1200 mg/day for body weight \>80 kg)

Protocol documents:
Clinical trial NCT01501513
Conditions: Colonoscopy Bowel Preparation Endoscopy
Keywords: colonoscopy bowel preparation endoscopy
Sponsor: Braintree Laboratories
Start date: 2011-12-01; Completion date: 2013-03-04
Enrollment: 541 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to compare the safety, tolerance and efficacy of BLI800 (approved and investigational regimens) to an approved control preparation as bowel preparations prior to colonoscopy in adult patients, particularly including the elderly and those with renal and/or hepatic impairment.

Detailed description:

Arms: arm 1: BLI800 approved preparation regimen arm 2: BLI800 investigational preparation regimen arm 3: PEG-3350 based bowel preparation
Interventions: intervention 1: PEG-3350 based bowel preparation intervention 2: BLI800 approved preparation regimen intervention 3: BLI800 investigational preparation regimen
Intervention descriptions: intervention 1: solution for oral administration prior to colonoscopy intervention 2: solution for oral administration prior to colonoscopy intervention 3: solution for oral administration prior to colonoscopy

Protocol documents: