ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01025830
Conditions: HIV/AIDS
Keywords: HIV;Bioequivalence;Triomune
Sponsor: Makerere University
Start date: 2006-02-01; Completion date: 2008-03-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The null hypothesis is that there is a difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans and the alternative hypothesis is that there is no difference in the the relative rate and extent of absorption into the systemic circulation of Triomune and brand-name Stavudine/Lamivudine/Nevirapine in HIV-infected Africans. This is a non-inferiority study.

Detailed description:
Generic antiretroviral therapy is the mainstay of HIV treatment in resource-limited settings, yet there is little evidence confirming the bioequivalence of generic and brand name formulations. We compared the steady-state pharmacokinetics of Lamivudine, Stavudine and Nevirapine in HIV-infected subjects who were receiving a generic formulation (Triomune®) or the corresponding brand formulations (Epivir®, Zerit®, and Viramune®). An open-label, randomized, crossover study was carried out in 18 HIV-infected Ugandan subjects stabilized on Triomune-40. Subjects received Lamivudine (150 mg), Stavudine (40 mg), and Nevirapine (200 mg) in either the generic or brand formulation twice a day for 30 days, before switching to the other formulation. At the end of each treatment period, blood samples were collected over 12 h for pharmacokinetic analysis. The main outcome measures were the mean AUC0-12h and Cmax. Bioequivalence was defined as a geometric mean ratio between the generic and brand-name within the 90% confidence interval of 0.8-1.25.

Arms: arm 1: generic fixed dose combination of Stavudine, Lamivudine and Nevirapine (Triomune) arm 2: 3 separate single pills of Zerit (Stavudine)Epivir (Lamivudine) Viramune (Nevirapine)
Interventions: intervention 1: Triomune intervention 2: Zerit/Epivir/Viramune
Intervention descriptions: intervention 1: Stavudine (40mg) Lamivudine (150mg) Nevirapine (200mg)All twice a day intervention 2: Stavudine (40mg) Lamivudine (150mg) and Nevirapine (200mg) All taken twice daily.

Protocol documents:
Clinical trial NCT01121926
Conditions: Healthy Subjects Bioavailability Pharmacokinetics
Keywords: Healthy subjects Bioavailability Pharmacokinetics Trazodone Steady-state
Sponsor: Labopharm Inc.
Start date: 2008-01-01; Completion date: 2008-03-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study was to compare the pharmacokinetic profiles at steady state of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered once daily, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp.), when administered three times daily, for one week. For this purpose, the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of multiple doses of up to 300 mg of each of the two formulations was compared.

Detailed description:

Arms: arm 1: OAD: Once A Day arm 2: None
Interventions: intervention 1: Trazodone HCl intervention 2: Trazodone HCl
Intervention descriptions: intervention 1: Dosage form:

Extended-release caplets containing 300 mg trazodone HCl and extended-release caplets containing 150 mg trazodone HCl (the 150 mg dosage form was only used for the up and down titration, and was not evaluated in the study).

Dose regimen:

75 mg trazodone HCl (½ x 150 mg extended-release caplet) on Days 1 and 11, 150 mg trazodone HCl (one extended-release caplet) on Days 2 and 10, 300 mg trazodone HCl (one extended-release caplet) on Days 3 to 9, each at 23:30 after a fast of at least 4 hours. intervention 2: Dosage form:

Immediate-release tablet containing 100 mg trazodone HCl

Dose regimen:

100 mg trazodone HCl (one immediate-release tablet) once (at 23:30) on Days 1 and 11, 100 mg trazodone HCl (one immediate-release tablet) twice (at 23:30 and 11:30) on Days 2 and 10, 100 mg trazodone HCl (one immediate-release tablet) three times daily (at 23:30, 07:30 and 15:30) on Days 3 to 9. Evening doses were administered after a fast of at least 4 hours.

Protocol documents:
Clinical trial NCT01365611
Conditions: Healthy Subjects
Sponsor: Egalet Ltd
Start date: 2007-02-01; Completion date: 2008-03-01
Enrollment: 36 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a non-randomized, open label study in healthy male and female volunteers. A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6; in addition, subjects received a daily intranasal dose of 200 µg fluticasone propionate on Days 2-6. Subjects remained resident in the Clinical Unit from the evening of Day 1 until the morning of Day 2 and from the evening of Day 5 until the morning of Day 7, and made ambulatory visits to the Clinical Unit on the morning of Days 3-5. A post study medical was performed within 7 days of study completion.

The objective of this study was to assess the effects of chronic administration of fluticasone propionate on the pharmacokinetics of intranasal ketorolac in healthy male and female subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ketorolac tromethamine intervention 2: Fluticasone Propionate
Intervention descriptions: intervention 1: A single intranasal dose of 30 mg ketorolac tromethamine was administered to all subjects on Days 1 and 6. intervention 2: Daily intranasal dose of 200 ug fluticasone propionate on Days 2-6

Protocol documents:
Clinical trial NCT01601821
Conditions: Inflammation
Sponsor: Pfizer
Start date: 2006-04-01; Completion date: 2008-03-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the safety and efficacy of cyclosporine (CsA) + mycophenolate mofetil (MMF) + corticosteroids © to CsA + Rapamune + Cs with CsA elimination in the Rapamune arm with the introduction of MMF in de novo renal allograft recipients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: CsA+Rapamune+CS intervention 2: CsA+MMF+CS
Intervention descriptions: intervention 1: Part 1: Rapamune will be given as a loading dose of 6 mg once followed by maintenance dose of 2 mg to achieve a target trough level of 8-15 ng/ml. Part 2: Rapamune dose will be adjusted to achieve a target trough level of 10-15ng/ml through 6 months intervention 2: The control arm is the standard local practice (official protocol) in Iran:

Cyclosporine + MMF + Corticosteroid. The time period is from pre-study screening / baseline evaluation up to 12 months for patients who are maintained on CsA + MMF + CS.

Protocol documents:
Clinical trial NCT01726335
Conditions: Schizophrenia
Keywords: Schizophrenia Risperidone Risperdal consta
Sponsor: Janssen-Cilag Ltd.
Start date: 2006-01-01; Completion date: 2008-03-01
Enrollment: 53 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate efficacy, safety and tolerance of long-acting risperidone when switching from oral antipsychotics in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions and hallucinations, and withdrawal into the self).

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-centric (conducted in more than one center) and non-comparative study of long-acting risperidone in participants with schizophrenia who have a previous history (in the last 12 months) of bad adherence to the oral antipsychotic treatment of first or second generation. The duration of this study will be 24 weeks and will include following visits: Screening, Baseline, Week 2, 4, 8, 12, 16, 20, 24, 38 and 50 (End visit or early withdrawal). All the eligible participants (after risperidone intolerance test during screening) will receive a dose of 25 milligram risperidone every two weeks by intramuscular injection (injection of a substance into a muscle). Efficacy and safety of the participants will primarily be evaluated by Positive and Negative Syndromes Scale and Extrapyramidal Symptom Rating Scale, respectively. Participants' safety will be monitored throughout the study.

Arms: arm 1: Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.
Interventions: intervention 1: Risperidone prolonged release
Intervention descriptions: intervention 1: Risperidone will be administered as intramuscular injection as 25 milligram (mg) every two weeks, from Week 1 to 50, wherein after Week 3, dose may be adjusted up to 50 mg at physician criterion. For first two weeks, previous oral antipsychotic drug will be maintained and the dose will be gradually decreased and will cease at Week 3.

Protocol documents:
Clinical trial NCT02013830
Conditions: Liver Cancer
Sponsor: Hoffmann-La Roche
Start date: 2005-05-01; Completion date: 2008-03-01
Enrollment: 45 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of oral Xeloda (capecitabine) plus intravenous Avastin (bevacizumab) in patients with advanced or metastatic liver cancer. The anticipated time on study treatment is 3-12 months.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: capecitabine [Xeloda]
Intervention descriptions: intervention 1: 7.5mg/kg iv on day 1 of each 3 week cycle. intervention 2: 1600mg/m2/day po in 2 divided doses, on days 1 to 14 of each 3 week cycle.

Protocol documents:
Clinical trial NCT02115581
Conditions: Dilated Cardiomyopathy
Keywords: Coenzyme O10 Children Idiopathic Dilated Cardiomyopathy
Sponsor: University of Tehran
Start date: 2006-09-01; Completion date: 2008-03-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy.

Detailed description:
This study aims to determine the effect of Coenzyme Q10 supplementation on conventional therapy of children with heart failure due to idiopathic dilated cardiomyopathy. In a prospective, randomized, double-blinded, placebo-controlled trial, patients younger than 18 years with idiopathic dilated cardiomyopathy randomizes to receive either Coenzyme Q10 or placebo. Echocardiographic systolic and diastolic function parameters are determined for every patient at baseline, after three,six and nine months of supplementation.

Arms: arm 1: Known cases of idiopathic dilated cardiomyopathy who received supplementation of coenzyme Q10 as a part of their medical regimen.

Dosage administered: 2 milligram/kilogram/day in 2 or 3 divided doses, these being increased to the maximum dose of 10 milligram/kilogram/day according to tolerance or the appearance of sideeffects. arm 2: known cases of idiopathic dilated cardiomyopathy who received placebo
Interventions: intervention 1: Coenzyme Q10 intervention 2: Placebo
Intervention descriptions: intervention 1: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance intervention 2: dose of 2 mg/kg/day in 2 or 3 divided doses and increased to the maximum dose of 10 mg/kg/day according to the patient's tolerance

Protocol documents:
Clinical trial NCT00686699
Conditions: Akathisia, Drug-Induced Dyskinesia, Drug-Induced Parkinsonian Disorders
Keywords: Anti-Dyskinesia Agents Antipsychotic Agents
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-07-10; Completion date: 2008-03-06
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study was designed to determine if preladenant (SCH 420814, MK-3814) can reduce drug-induced involuntary movements in participants with schizophrenia or schizoaffective disorder. Participants were to be evaluated for two 14-day treatment periods with a 3-week washout period between treatment periods. The primary outcome measure, Extrapyramidal Symptom Rating Score (ESRS), was to be evaluated frequently during the treatment periods.

Detailed description:

Arms: arm 1: Participants received one preladenant 25 mg capsule twice daily (BID) for 14 days during the first treatment period and received one matching placebo capsule BID during the second treatment period. The 2 treatment periods were separated by a 3-week washout period. arm 2: Participants received one matching placebo capsule BID for 14 days during the first treatment period and received one preladenant 25 mg capsule during the second treatment period. The 2 treatment periods were separated by a 3-week washout period.
Interventions: intervention 1: Preladenant intervention 2: Placebo
Intervention descriptions: intervention 1: capsules intervention 2: capsules

Protocol documents:
Clinical trial NCT00283933
Conditions: Fabry Disease
Keywords: Amicus Therapeutics AT1001 Galafold Migalastat Substrate
Sponsor: Amicus Therapeutics
Start date: 2006-05-09; Completion date: 2008-03-12
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Study to evaluate the safety, tolerability, and pharmacodynamics of migalastat hydrochloride (HCl) (migalastat) in participants with Fabry disease.

Detailed description:
This was a Phase 2, open-label study in male participants with Fabry disease. The study consisted of a 4-week screening period, during which participants' galactosidase (GLA) genotype was assessed for α-galactosidase A (α-Gal A) activity in response to migalastat. Participants were required to have α-Gal A activity responsive to migalastat. The study consisted of a 24-week treatment period, followed by an optional 24-week extension period. Participants received migalastat once every other day (QOD) for 24 weeks during the treatment period and the optional 24-week extension for a total treatment duration of up to 48 weeks.

Arms: arm 1: Migalastat 150 milligrams (mg) was administered orally QOD during the 24-week treatment period and then during the optional 24-week extension period.
Interventions: intervention 1: migalastat HCl
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00244751
Conditions: Cirrhosis, Liver
Keywords: Hepatitis C liver fibrosis
Sponsor: GlaxoSmithKline
Start date: 2005-11-02; Completion date: 2008-03-13
Enrollment: 265 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to examine the safety and effectiveness of GI262570 compared to placebo (a pill that looks exactly like GI262570 but contains no active medicine) in improving specific tests that indicate the degree of liver fibrosis (scarring). Subjects who are enrolled in the study must have had prior treatment with interferon (either pegylated or standard interferon) plus ribavirin for at least 12 weeks to treat their hepatitis C, but either failed to clear the virus or didn't tolerate the treatment.

Detailed description:

Arms: arm 1: Participants received GI262570 0.5 milligrams (mg) tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52. arm 2: Participants received GI262570 1.0 mg tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52. arm 3: Participants received matching placebo tablet once daily approximately 30 minutes prior to breakfast for 52 weeks. Participant received their morning dose at the site on Weeks 2, 16, 28, 40, and 52.
Interventions: intervention 1: GI262570 0.5 mg intervention 2: GI262570 1.0 mg intervention 3: Placebo
Intervention descriptions: intervention 1: GI262570 0.5 mg intervention 2: GI262570 1.0 mg intervention 3: Placebo

Protocol documents:
Clinical trial NCT00219557
Conditions: Pancreatic Neoplasms
Keywords: Randomized Phase 2 Study of AG-013736 in Combination with Gemcitabine versus Gemcitabine Alone in Advanced Pancreatic Cancer
Sponsor: Pfizer
Start date: 2005-07-05; Completion date: 2008-03-14
Enrollment: 111 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Phase 2 study being conducted at multiple centers in the United States, Europe and Canada. Patients having pancreatic cancer that is locally advanced or that has spread to other parts of the body (i.e., metastatic) are eligible to participate. Patients must have not had any prior systemic treatment for advanced disease. The purpose of the study is to test whether the angiogenesis inhibitor Axitinib \[AG-013736\] in combination with gemcitabine is an effective treatment for advanced pancreatic cancer vs. gemcitabine alone by overall survival.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Gemcitabine intervention 2: AG-013736 intervention 3: Gemcitabine
Intervention descriptions: intervention 1: Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks intervention 2: Axitinib (AG-013736) 5 mg tablet orally BID starting from Day 1 of Cycle 1, in cycles of 4 weeks. intervention 3: Gemcitabine 1000 mg/m\^2 30 minutes IV infusion on Day 1, 8 and 15 of each cycle, in cycles of 4 weeks.

Protocol documents:
Clinical trial NCT00102531
Conditions: Osteosarcoma Metastatic
Keywords: Osteosarcoma relapsed progressive metastatic lung
Sponsor: Insmed Incorporated
Start date: 2005-01-12; Completion date: 2008-03-17
Enrollment: 19 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Phase Ib/IIa open label safety and efficacy study designed to determine the maximum tolerated dose of inhaled cisplatin liposomal (SLIT cisplatin) administered every 14 days to patients with relapsed/progressive osteosarcoma metastatic to the lung.

Detailed description:

Arms: arm 1: Inhaled liposomal cisplatin was administered over 1 day in a 14-day treatment cycle by inhalation for a maximum of 6 cycles. arm 2: The study allowed for a dose escalation of liposomal cisplatin to 36 mg/m2 if no adverse events of Grade 3 or higher occurred after at least 3 cycles of drug administration at 24 mg/m2
Interventions: intervention 1: Cisplatin liposomal
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00110266
Conditions: Myelodysplastic Syndrome Iron Overload
Keywords: ICL670 Deferasirox Iron chelation Chelator Desferal
Sponsor: Novartis Pharmaceuticals
Start date: 2005-07-25; Completion date: 2008-03-28
Enrollment: 176 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this trial is to examine the safety and efficacy of deferasirox in patients with Myelodysplastic Syndrome (MDS) and chronic iron overload from blood transfusions.

Detailed description:
Study entry requires a diagnosis of low or intermediate (INT-1) risk MDS per International Prognostic Scoring System (IPSS) criteria and serum ferritin ≥ 1000 ng/mL. Patients must have had at least 30 prior red blood cell transfusions. Deferasirox will be administered at an initial dose of 20 mg/kg orally once per day. Patient transfusion history and at least three complete blood count (CBC) values must be available for the 12 weeks prior to study registration for patients with MDS and chronic iron overload from blood transfusions.

Arms: arm 1: Evaluate the safety and tolerability of deferasirox 20 mg/kg/day over one year in patients with MDS
Interventions: intervention 1: Deferasirox
Intervention descriptions: intervention 1: 20 mg/kg/day over one year in patients with MDS

Protocol documents:
Clinical trial NCT00110591
Conditions: HIV Infections
Sponsor: CytoDyn, Inc.
Start date: 2004-04-16; Completion date: 2008-03-31
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the safety and tolerability of PRO 140, an investigational anti-HIV drug, administered via intravenous infusion.

Study hypothesis: Single intravenous doses of PRO 140 can be safely administered to humans and will result in measurable concentrations of the product in serum.

Detailed description:
PRO 140 is a man-made monoclonal antibody to the chemokine receptor CCR5, which serves as a co-receptor for HIV. In numerous preclinical models of HIV infection, PRO 140 broadly and potently blocks CCR5-mediated HIV entry without blocking the natural activity of CCR5. PRO 140 is being developed for therapy of HIV infected individuals. The purpose of this study is to evaluate the safety and tolerability of PRO 140 in HIV uninfected male volunteers. The pharmacokinetics and pharmacodynamics of PRO 140 will also be assessed in this study.

Participants in this study will be randomly assigned to receive a single dose of one of several possible doses of PRO 140 or placebo. Participants will remain in the clinic for observation and evaluation for 24 hours after the single-dose administration. Follow-up visits will occur at 2, 3, 5, 7, 10, 14, 28, 42, and 60 days post-treatment. Physical exams, electrocardiograms (ECGs), vital signs measurement, adverse event reporting, and blood and urine collection will occur at most visits.

Arms: arm 1: Intravenous placebo for PRO 140 arm 2: 0.1 mg/kg PRO 140 by intravenous infusion arm 3: 0.5 mg/kg PRO 140 by intravenous infusion arm 4: 2.0 mg/kg PRO 140 by intravenous infusion arm 5: 5.0 mg/kg PRO 140 by intravenous infusion
Interventions: intervention 1: PRO 140
Intervention descriptions: intervention 1: Monoclonal antibody to CCR5

Protocol documents: