ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01206101
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2012-03-21; Completion date: 2013-06-03
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Europe and North America. The aim of this trial is to investigate if liraglutide treatment can increase the proportion of insulin-independent subjects one year after islet cell transplantation who required only one (single-donor) islet cell transplant.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: liraglutide intervention 2: placebo
Intervention descriptions: intervention 1: Dose escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide dose for 52 weeks. Injected subcutaneously(under the skin) once daily. intervention 2: Dose escalation escalation of liraglutide up to 1.2 to 1.8 mg before islet cell transplant until the planned number of transplanted subjects is complete or subject is transplanted. After islet cell transplant, subjects continue to receive the reached liraglutide placebo dose for 52 weeks. Injected subcutaneously (under the skin) once daily.

Protocol documents:
Clinical trial NCT01760187
Conditions: Healthy Volunteer
Sponsor: Aegerion Pharmaceuticals, Inc.
Start date: 2012-11-07; Completion date: 2013-06-03
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, single ascending dose (SAD) and multiple ascending dose (MAD) study of orally administered lomitapide in healthy male Japanese and Caucasian subjects with elevated LDL-C. The purpose for this study is to evaluate the PK and PD of lomitapide in Japanese subjects as compared to Caucasian subjects.

Detailed description:

Arms: arm 1: 12 Japanese and 12 Caucasian subjects. 10 out of 12 will receive 10 mg lomitapide and 2 will receive placebo. arm 2: 8 Japanese and 8 Caucasian subjects. 6 out of 8 subjects will receive 20 mg lomitapide and 2 will receive placebo. arm 3: 8 Japanese and 8 Caucasian subjects. 6 out of 8 subjects will receive 40 mg lomitapide and 2 will receive placebo. arm 4: 8 Japanese and 8 Caucasian subjects. 6 out of 8 subjects will receive 60 mg lomitapide and 2 will receive placebo.
Interventions: intervention 1: lomitapide
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01736579
Conditions: Alzheimer´s Disease
Sponsor: Baxalta now part of Shire
Start date: 2012-11-29; Completion date: 2013-06-04
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this long-term study is to provide additional evidence of safety and efficacy of IGIV, 10% treatment in participants with Alzheimer´s Disease who have completed the Phase 3 Baxter precursor study 160701. All participants will receive IGIV, 10% at either 0.2 g/kg or 0.4 g/kg body weight depending on their treatment assignment in Baxter study 160701. Participants and investigators will be blinded to dose unless otherwise notified by the sponsor.

Detailed description:

Arms: arm 1: IGIV, 10% at 0.2 g/kg body weight every 2 weeks for up to 3 years, 6 months. arm 2: IGIV, 10% at 0.4 g/kg body weight every 2 weeks for up to 3 years, 6 months
Interventions: intervention 1: Immune Globulin Intravenous (Human), 10% (IGIV, 10%)
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01462266
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2012-01-13; Completion date: 2013-06-07
Enrollment: 660 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the insulin-sparing effect of sitagliptin 100 mg once-daily compared with placebo over 24 weeks in participants with type 2 diabetes mellitus who have inadequate glycemic control on insulin alone or in combination with metformin. The primary hypothesis of this study is that after 24 weeks, sitagliptin reduces the dose of insulin relative to placebo.

Detailed description:

Arms: arm 1: Sitagliptin 100 mg once daily arm 2: Placebo to sitagliptin once daily
Interventions: intervention 1: Sitagliptin intervention 2: Comparator: Placebo intervention 3: Insulin Glargine intervention 4: Metformin
Intervention descriptions: intervention 1: Sitagliptin 100 mg tablet once daily for 24 weeks intervention 2: Placebo to sitagliptin once daily for 24 weeks intervention 3: Participants on insulin glargine or another insulin regimen for at least 10 weeks prior to screening will continue or switch to open-label insulin glargine once-daily in the evening for the duration of the study. intervention 4: Participants on metformin oral tablet(s) at a dose of at least 1500 mg/day for at least 10 weeks prior to screening will continue receiving metformin at their current dose for the duration of the study.

Protocol documents:
Clinical trial NCT00570661
Conditions: Active Systemic Onset Juvenile Idiopathic Arthritis
Sponsor: Italfarmaco
Start date: 2006-09-12; Completion date: 2013-06-10
Enrollment: 17 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study has the following objectives:

Primary objective:

\- To determine the safety and tolerability of oral ITF2357 in patients with active SOJIA with inadequate response or intolerance to standard therapy with oral steroids and methotrexate, with or without previously used biologic agents.

Secondary objectives:

* to evaluate the effect of ITF2357 on disease activity in patients with active SOJIA
* to investigate the possibility of steroid dose tapering in patients with active SOJIA during ITF2357 treatment
* to assess the effect of ITF2357 on levels of circulating cytokines
* to assess the pharmacokinetic properties of ITF2357

Detailed description:
The present study has been designed in order to evaluate safety and tolerability of ITF2357 in patients with active SOJIA with inadequate response or intolerance to standard therapy with oral steroids and methotrexate, with or without previously used biologic agents, and to have a preliminary evaluation of efficacy of ITF2357 in the treatment of SOJIA.

ITF2357 will be administered orally at the daily cumulative dose of 1.5 mg/kg: this dose in children/young adults is considered roughly equivalent to the dose of 1 mg/kg/day in adults, which so far has been proven to be free of any relevant safety concerns both in healthy volunteers and in patients.

Arms: arm 1: ITF2357 hard gelatine capsules were administered orally, in fed conditions, at the cumulative daily dose of 1.5 mg/kg achieved by administration of 0.75 mg/kg at 12-hour interval for 4 weeks initially. The doses of 1.5 mg/kg/day were achieved by administration of an appropriate number of capsules of definite strength (dose strengths of 7.5, 10, 12.5, 15, 20 mg and 50 mg).

Treatment was further prolonged up to 12 weeks in total if so suggested by the observed benefits and the lack of treatment-limiting toxicity
Interventions: intervention 1: ITF2357
Intervention descriptions: intervention 1: ITF2357 orally administered at the cumulative daily dose of 1.5 mg/kg, achieved by administration of different dose strengths identifiable by different colours.

Protocol documents:
Clinical trial NCT01429792
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2008-09-25; Completion date: 2013-06-10
Enrollment: 1013 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This multi-center study will evaluate the viral response in patients with chronic hepatitis C, genotype 1, 2, 3 \& 4 on standard anti-viral treatment with Pegasys (peginterferon alfa-2a) and Copegus (ribavirin). Patients will receive weekly subcutaneous Pegasys plus daily oral Copegus for 24 weeks (genotype 2 \& 3) or 48 weeks (genotype 1 \& 4). Patients identified as slow responders/non-rapid virological responders will be eligible for an additional 24 weeks of treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: ribavirin [Copegus]
Intervention descriptions: intervention 1: standard treatment, subcutaneously weekly intervention 2: standard treatment, orally daily

Protocol documents:
Clinical trial NCT01714947
Conditions: Advanced Solid Tumors Lymphoma
Keywords: Drug Therapy
Sponsor: Millennium Pharmaceuticals, Inc.
Start date: 2013-01-24; Completion date: 2013-06-14
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the mass balance (i.e. cumulative excretion of total radioactivity \[TRA\] in urine and feces) of alisertib and pharmacokinetic (PK) of alisertib in plasma and urine, and of TRA in plasma and whole blood.

Detailed description:
The drug being tested in this study is called alisertib (MLN8237). Alisertib is being tested to treat participants who have advanced solid tumors or lymphomas. This study looked at mass balance, pharmacokinetics (PK), metabolism, elimination and safety of alisertib.

The study enrolled 3 patients. The study consisted of 2 parts: Part A and Part B. Participants received:

* \[\^14C\]-alisertib 35 mg in Part A
* alisertib 50 mg in Part B

Participants were asked to take a single dose of \[\^14C\]-alisertib oral solution containing 80-100 μCi of total radioactivity (1.19-1.48 mCi/mmol) in Part A and alisertib 50 mg, orally, twice daily for 7 days in 21-day cycles until disease progression or unacceptable toxicity in Part B.

This single center trial was conducted in United States. The overall time to participate in this study was up to 117 days. Participants remained confined to clinic in Part A and made multiple visits to the clinic in Part B. Participants were contacted 30 days after last dose of alisertib in Part A (if not continuing in Part B), or were contacted by telephone or a final visit 30 days after receiving their last dose of alisertib in Part B for a follow-up assessment.

Arms: arm 1: Part A: \[\^14C\]-alisertib 35 mg, oral solution containing 80 - 100 microcuries (μCi) of total radioactivity (1.19 - 1.48 mCi/mmol), orally, single dose on Day 1.

Part B: Alisertib 50 mg, enteric coated tablets, orally, twice daily for 7 days, followed by 14-day washout period in 21-day cycles until disease progression or unacceptable treatment-related toxicity (Up to 3 Cycles).
Interventions: intervention 1: [^14C]-alisertib intervention 2: alisertib
Intervention descriptions: intervention 1: \[\^14C\]-alisertib oral solution intervention 2: Alisertib enteric coated tablets

Protocol documents:
Clinical trial NCT01737684
Conditions: Overactive Bladder
Sponsor: Merck Sharp & Dohme LLC
Start date: 2013-01-15; Completion date: 2013-06-14
Enrollment: 16 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate the pharmacokinetics of a single oral dose of vibegron (MK-4618) administered to participants with moderate hepatic insufficiency and healthy participants matched for age, gender, and body mass index (BMI). Participants may be enrolled with mild hepatic insufficiency.

Detailed description:
This study is planned to be conducted in two parts. Part 1 of the study will include participants with moderate hepatic insufficiency and healthy participants. If Part 2 is conducted, Part 2 of the study will include participants with mild hepatic insufficiency.

Arms: arm 1: Participants with moderate hepatic insufficiency will receive a single oral dose of vibegron 100 mg. arm 2: Participants who are healthy will receive a single oral dose of vibegron 100 mg. arm 3: Participants with mild hepatic insufficiency will receive a single oral dose of vibegron 100 mg.
Interventions: intervention 1: Vibegron
Intervention descriptions: intervention 1: 50 mg tablet, oral

Protocol documents:
Clinical trial NCT01557166
Conditions: Metabolism and Nutrition Disorder Obesity Obstructive Sleep Apnoea
Keywords: OSA
Sponsor: Novo Nordisk A/S
Start date: 2012-06-07; Completion date: 2013-06-17
Enrollment: 359 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in North America. The aim of the trial is to investigate the effect of liraglutide in obese subjects with sleep apnoea.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: liraglutide intervention 2: placebo
Intervention descriptions: intervention 1: 3.0 mg liraglutide administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise intervention 2: Placebo administered subcutaneously (s.c., under the skin) once daily for 32 weeks + diet and exercise

Protocol documents:
Clinical trial NCT01668654
Conditions: Epilepsy
Keywords: Epilepsy Partial Onset epilepsy Lennox-Gastaut Syndrome Open-label extension study
Sponsor: GlaxoSmithKline
Start date: 2012-09-04; Completion date: 2013-06-18
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the long-term safety and tolerability of retigabine/ezogabine as an adjunctive treatment in subjects with either partial onset seizures (12 to \< 18 years old) or Lennox-Gastaut Syndrome (12 to \<30 years old) who have participated in a previous ("parent") study.

Detailed description:
Epilepsy is among the most common serious neurologic disorders in childhood. Medicines with novel actions of mechanisms of action are needed to try to address the unmet clinical need for seizure control in patients with treatment-resistant epilepsy. The purpose of this study is to evaluate the long-term safety and tolerability of retigabine/ezogabine as an adjunctive treatment in subjects with either partial onset seizures (12 to \< 18 years old) or Lennox-Gastaut Syndrome (12 to \<30 years old) who have participated in a previous ("parent") study.

Arms: arm 1: retigabine/ezogabine will be administered three times a day (TID) as add-on therapy based on weight
Interventions: intervention 1: retigabine/ezogabine
Intervention descriptions: intervention 1: retigabine/ezogabine will be administered three times a day (TID) as add-on therapy based on weight

Protocol documents:
Clinical trial NCT00701896
Conditions: Smoking HIV Infections
Keywords: HIV Positive Smokers Varenicline
Sponsor: Philip Diaz
Start date: 2008-10-03; Completion date: 2013-06-20
Enrollment: 294 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
People that are infected with HIV appear to be especially susceptible to the adverse effects of cigarette smoking. The purpose of this study is to determine if quitting smoking by using a specialized smoking cessation treatment can prevent one from developing accelerated lung damage, particularly emphysema.

Detailed description:
HIV-infected smokers are at increased risk for life-threatening diseases, such as pneumonia. To date, very little is known about the tobacco consumption characteristics of this at-risk population of smokers, but it has been well documented that they are at high risk for smoking-related co-morbidities. In addition, few effective cessation strategies have been described in HIV-infected populations. A specialized smoking cessation that combines recommendations from an existing scientifically-valid clinical guideline with Motivational Interviewing a new pharmacotherapeutic agent, may be an effective mechanism to apply to this vulnerable population of smokers. This initial, efficacy investigation has the potential to guide future treatment and research pertaining to tobacco cessation, respiratory illness and HIV.

Arms: arm 1: Healthy Control arm with 51 subjects who are HIV negative and do not smoke arm 2: Healthy Control arm, includes 50 subjects who are HIV negative and are smokers. arm 3: Includes up to 365 subjects who are HIV positive and initiate smoking cessation arm 4: Includes up to 100 subjects who are HIV positive, do not wish to quit smoking but are willing to undergo one-on-one Motivational Intervention
Interventions: intervention 1: Varenicline tartrate intervention 2: Nicotine Replacement Therapy intervention 3: Biological Control intervention 4: Motivational Interview
Intervention descriptions: intervention 1: 1 mMg tablet form; daily during week 1 (pre-quit week) followed by 1 mg twice daily for weeks 2-12. intervention 2: Nicotine gum and nicotine patch intervention 3: No treatment intervention only information and procedures. intervention 4: 60 minute one-on-one Interview

Protocol documents:
Clinical trial NCT01518946
Conditions: Orthostatic Hypotension
Keywords: Symptomatic Orthostatic Hypotension
Sponsor: Shire
Start date: 2012-05-14; Completion date: 2013-06-22
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether midodrine works against the symptoms of orthostatic hypotension caused by being on a tilt table.

Detailed description:
The efficacy of midodrine will be assessed in those subjects who have severe symptoms of orthostatic hypotension when not taking midodrine and are controlled when taking midodrine. The study will involve approximately 4 overnight stays.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Midodrine HCl intervention 2: Placebo
Intervention descriptions: intervention 1: dose at the subject's current dose level intervention 2: single dose of matching placebo

Protocol documents:
Clinical trial NCT00462943
Conditions: Chronic Myeloid Leukemia
Keywords: CML HHT Homoharringtonine Omacetaxine
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2007-03-07; Completion date: 2013-06-27
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A Phase II open-label trial of subcutaneous HHT (omacetaxine mepesuccinate) in the treatment of patients who are resistant to or intolerant to Tyrosine Kinase Inhibitors.

Detailed description:
This will be an open label, multicenter study of subcutaneous HHT (omacetaxine mepesuccinate) therapy of patients with chronic myeloid leukemia (CML) in chronic, accelerated, or blast phase who have failed or are intolerant to tyrosine kinase inhibitor therapy. Patients will be treated with induction course cycles consisting of subcutaneous (SC) HHT 1.25 mg/m² twice daily for 14 consecutive days every 28 days. Patients will be evaluated every 7 days with complete blood and platelet counts while undergoing induction therapy; the number of consecutive doses of HHT or intervals between subsequent cycles may be adjusted, as clinically indicated, according to guidelines provided in the treatment plan.

Arms: arm 1: Omacetaxine mepesuccinate (OMA) Induction: 1.25mg/m\^2 subcutaneously twice daily for 14 consecutive days, every 28 days for up to six cycles.

Omacetaxine mepesuccinate (OMA) Maintenance: 1.25mg/m\^2 subcutaneously twice daily for 7 consecutive days, every 28 days for up to 24 months.
Interventions: intervention 1: Omacetaxine mepesuccinate
Intervention descriptions: intervention 1: Induction: 1.25mg/m\^2 subcutaneously twice daily for 14 consecutive days, every 28 days.

Maintenance: 1.25mg/m\^2 subcutaneously twice daily for 7 consecutive days, every 28 days.

Response targets during induction vary by chronic myeloid leukemia (CML) subclass (chronic, accelerated, or blast phase). Participants will complete at least one cycle (14 days treatment of a 28 day cycle) of induction therapy before changing to maintenance therapy. Participants not demonstrating evidence of clinical response after 6 induction cycles will be considered for removal from the study.

Protocol documents:
Clinical trial NCT00868608
Conditions: Lymphoma
Keywords: Refractory Indolent NHL lymphoma
Sponsor: Pfizer
Start date: 2009-07-30; Completion date: 2013-06-27
Enrollment: 81 participants; Allocation: ; Intervention model: 

Brief summary:
The purpose of this study is to evaluate the efficacy of inotuzumab ozogamicin (CMC-544) in subjects with indolent Non-Hodgkins lymphoma (NHL) that is refractory or has relapsed after multiple therapies including rituximab or radioimmunotherapy. The investigational drug will be given to subjects with indolent NHL by intravenous infusion at a dose of 1.8 mg/m2, every 4 weeks.

Detailed description:

Arms: arm 1: inotuzumab ozogamicin
Interventions: intervention 1: Inotuzumab Ozogamicin (CMC-544)
Intervention descriptions: intervention 1: Administered intravenously at 1.8 mg/m2 every 4 weeks for a planned 4 - 8 cycles

Protocol documents:
Clinical trial NCT01130844
Conditions: Ulcerative Colitis
Sponsor: Shire
Start date: 2010-10-08; Completion date: 2013-06-27
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and pharmacokinetics of MMX mesalamine following administration in children and adolescents with ulcerative colitis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MMX Mesalamine intervention 2: MMX Mesalamine intervention 3: MMX Mesalamine
Intervention descriptions: intervention 1: 30 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. intervention 2: 60 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days. intervention 3: 100 mg/kg/day of MMX Mesalamine tablets, dosed once daily for 7 days.

Protocol documents:
Clinical trial NCT01254019
Conditions: Muscular Dystrophies
Keywords: Duchenne Muscular Dystrophy DMD 968 GSK Duchenne
Sponsor: GlaxoSmithKline
Start date: 2010-12-02; Completion date: 2013-06-28
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether GSK2402968 is effective in the treatment of ambulant boys with Duchenne muscular dystrophy resulting from a mutation thought to be corrected by exon 51 skipping.

Detailed description:

Arms: arm 1: 6mg/kg arm 2: dose-matched
Interventions: intervention 1: GSK2402968 6mg/kg/week
Intervention descriptions: intervention 1: subcutaneous

Protocol documents:
Clinical trial NCT04531527
Conditions: Dermatitis, Phototoxic
Sponsor: Bayer
Start date: 2013-06-24; Completion date: 2013-06-28
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
In this study researchers want to gather information about the potential of Antifungal Cream V61-044 containing Trolamine to produce a phototoxic reaction on the skin. A phototoxic reaction is an irritant reaction of the skin to ultra violet light. In order to find this out the study drug will be applied to the skin of healthy human subjects. By using a solar simulator to generate a UV spectrum similar to that of sunlight the potential of the study drug to produce a superficial reddening of the skin will be measured.

Detailed description:

Arms: arm 1: Participants received approximately 60 μl of Butenafine HCl 1% on the treated irradiated test site followed by Ultraviolet Radiation (UV) irradiation and to the treated non-irradiated test site without UV irradiation. Participants also had two more test sites, the untreated irradiated control site without Butenafine HCl 1% followed by UV irradiation and the untreated non-irradiated control site without Butenafine HCl 1% or UV irradiation. All test sites were evaluated for erythema on the following day. Afterwards, participants received same procedure on all 4 test sites, and evaluation of the test sites occurred at 24 hours and 48 hours post-irradiation.
Interventions: intervention 1: Butenafine HCl 1% (BAY1896425)
Intervention descriptions: intervention 1: Approximately 60 μl of Butenafine HCl 1% applied twice to the treated irradiated site and to the treated non-irradiated site for a total application of 240 μl of Butenafine HCl 1%.

Protocol documents: