ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01374438
Conditions: Alzheimer's Disease
Keywords: Alzheimer's disease cognitive function brain glucose utilization FDG-PET
Sponsor: Metabolic Solutions Development Company
Start date: 2011-07-01; Completion date: 2013-05-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of 150 mg MSDC-0160 taken daily for 90 days compared to the effect of placebo on changes in brain glucose utilization using FDG-PET and cognition in older persons with mild Alzheimer's disease. Safety and tolerability of MSDC-0160 in this population will also be studied. These results will be used to design larger studies of MSDC-0160 in persons with mild Alzheimer's disease.

Detailed description:
The specific objective is to examine the feasibility of conducting future large scale studies on the efficacy of MSDC-0160 in persons with mild Alzheimer's disease. Efficacy and safety will be assessed as follows:

1. Estimate the effect size of 150 mg daily MSDC-0160 versus placebo on 3-month change in brain glucose utilization using FDG-PET pre-specified regions of interest analysis. The a priori regions of interest (ROI) will include five bilateral regions: posterior cingulate, parietal cortex (angular gyrus), lateral temporal cortex, medial temporal cortex, and anterior cingulate-medial frontal cortex.
2. Estimate the effect size of MSDC-0160 versus placebo on 3-month change in brain glucose utilization, using FDG-PET voxel-based analysis.
3. Estimate the effect size of MSDC-0160 treatment versus placebo on 3-month change in cognitive function as determined by global cognitive function on a neuropsychological battery of 19 tests.
4. Estimate the effect size of MSDC-0160 versus placebo on 3-month change in cognitive function as determined by the ADAS-Cog subscale.
5. Estimate the effect of 3-months of MSDC-0160 treatment versus placebo on a 9-item executive function scale.
6. Explore whether baseline levels of peripheral inflammatory biomarkers (HMW adiponectin, TNFα, IL-6, hsCRP, and FFA) or genotypes including, but not limited to, the apolipoprotein ε4 allele explain the heterogeneity in baseline level of brain glucose utilization and, in MSDC-0160 users, 3-month brain glucose utilization.
7. Explore whether changes in peripheral inflammatory biomarkers correlate with changes in 3-month brain glucose utilization in MSDC-0160 users.
8. Investigate the safety of MSDC-0160 versus placebo using reports of early study termination and adverse events.

Arms: arm 1: MSDC tablets contained in #00 capsules arm 2: Placebo tablets contained in #00 capsules
Interventions: intervention 1: MSDC-0160 intervention 2: Placebo
Intervention descriptions: intervention 1: MSDC-0160 150 mg capsules given once daily for 90 days intervention 2: Placebo capsules given once daily for 90 days

Protocol documents:
Clinical trial NCT01375049
Conditions: Cystic Fibrosis
Keywords: Cystic fibrosis CF PA Pseudomonas aeruginosa AZLI aztreonam
Sponsor: Gilead Sciences
Start date: 2011-08-01; Completion date: 2013-05-01
Enrollment: 105 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi-center study in pediatric patients age 3 months to less than 18 years with cystic fibrosis (CF) and newly detected Pseudomonas aeruginosa (PA) pulmonary colonization/infection. All eligible participants will be treated with a 28-day course of Aztreonam for Inhalation Solution (AZLI) 75 mg 3 times daily. After completion of study drug, subjects will be followed up through Day 196 for safety and recurrence of PA.

The primary objective is to evaluate the proportion of participants with PA-negative cultures at all time points during a 6-month monitoring period (through Day 196) after cessation of AZLI treatment. Microbiological cultures will be obtained at Baseline, Day 28 (end of AZLI treatment), Day 56 (1 month after completing AZLI treatment), Day 112 (3 months after completing AZLI treatment), and Day 196 (6 months after completing AZLI treatment).

Detailed description:

Arms: arm 1: Participants will receive one 28-day course of AZLI, then will be followed for a 24-week period (through Day 196).
Interventions: intervention 1: Aztreonam for Inhalation Solution (AZLI)
Intervention descriptions: intervention 1: AZLI 75 mg administered 3 times daily via the investigational eFlow® nebulizer

Protocol documents:
Clinical trial NCT01377441
Conditions: Inflammatory Response
Keywords: Ibuprofen Cytokines Recovery IV ibuprofen major surgery
Sponsor: NYU Langone Health
Start date: 2011-09-01; Completion date: 2013-05-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The administration of anti-inflammatory drugs such as ibuprofen before and after surgery has not been studied extensively. Subjects are being asked to participate in this study because they are scheduled for surgery and because the investigators want to study ways to improve recovery from surgery. Ibuprofen will be given several times before and after surgery. The investigators will ask questions to determine recovery and the investigators will draw blood to determine inflammatory response.

Detailed description:
Human and animal studies suggest cyclooxygenase-inhibitors (COX-inhibitors) decrease the production of inflammatory mediators. Studies also suggest that COX inhibitors attenuate increases in corticosterone and eicosanoid levels after endotoxin injection. COX inhibitors also appear to have anticancer effects, inhibiting angiogenesis, tumor growth, and metastatic burden. These results suggest a role for IV ibuprofen in preventing untoward inflammatory responses, shortening post-surgical convalescence, improving patient satisfaction, and reducing the rate of complications occurring during the recovery from surgery. However, there are no studies that have evaluated the relationship between administration of IV ibuprofen, ensuing immunomodulation, and long-term outcomes.

Study Objective. The aim of the proposed study is to examine the effect of intravenous(IV) ibuprofen on the inflammatory response in major surgery. More importantly, the investigators will correlate changes in the concentration of inflammatory mediators with meaningful clinical outcomes.

Arms: arm 1: Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo. arm 2: Eligible subjects will be randomized to one of the two treatment group in a 1:1 ratio to receive either IV ibuprofen or matching placebo
Interventions: intervention 1: Ibuprofen intervention 2: Placebo/Saline solution
Intervention descriptions: intervention 1: Patients will receive either 800mg IV ibuprofen or placebo pre-operatively. Post-operatively, patients will receive either 800mg IV ibuprofen or placebo 6 hours after the first dose. intervention 2: Patients will receive placebo pre-operatively. Post-operatively, patients will receive placebo at least 6 hours after the initial dose.

Protocol documents:
Clinical trial NCT01383993
Conditions: Aspergillosis, Aspergilloma
Keywords: Open-Label Pharmacokinetics Intravenous to oral switch Safety Voriconazole Immunocompromise Children High Risk For Systemic Fungal Infection
Sponsor: Pfizer
Start date: 2011-09-01; Completion date: 2013-05-01
Enrollment: 21 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
In this study we will measure the concentration of the drug called voriconazole which is used to fight infections caused by fungus in children who usually are cancer patients and have their immune system down. Since we know the dose in adults, and we think we know the matching doses in the young patients ages 2 to less than 15 years old, we will compare the amount of drug that goes into the system with what we know works in adults. We give the drug by a needle directly into the blood, then few days later we stop that and give the drug by mouth. Meanwhile, we draw a little bit of blood at certain times to measure the drug in it.

Detailed description:

Arms: arm 1: Immunocompromised children aged 2 to \<15 and 12 to \<15 years weighing \<50 kg who are at high risk for systemic fungal infection. arm 2: Immunocompromised children aged 12 to \<15 years weighing more than 50 kg who are at high risk for systemic fungal infection.
Interventions: intervention 1: Voriconazole intervention 2: Voriconazole
Intervention descriptions: intervention 1: Study Days 1: IV voriconazole 9 mg/kg q12h. Study Days 2 to 7: IV voriconazole 8 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 9 mg/kg q12h with a maximum of 350 mg q12 h.

Notes:

If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.

Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.

(IV = Intravenous; POS = Powder for oral suspension) intervention 2: Study Days 1: IV voriconazole 6 mg/kg q12h. Study Days 2 to 7: IV voriconazole 4 mg/kg q12h. Study Days 8 to 14: Oral voriconazole (POS) 200 mg q12h.

Notes:

If unable to switch to oral medication on Day 8, subjects can continue with IV treatment up to Day 20 before switching to oral dose.

Only morning oral dose will be given on Day 14 (or the seventh day of oral dosing if IV regimen is extended). However, if clinically indicated, voriconazole treatment may be continued up to Day 30.

(IV = Intravenous; POS = Powder for oral suspension)

Protocol documents:
Clinical trial NCT01388790
Conditions: Gastric Cancer
Keywords: Gastric Cancer Cetuximab EMD271786 TS-1 Cisplatin
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2011-06-01; Completion date: 2013-05-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, single-arm, multicenter, Phase 2 trial will treat at least 40 participants with advanced gastric adenocarcinoma including adenocarcinoma of the gastroesophageal junction (GEJ) who have not previously received systemic chemotherapy for this setting.

All eligible participants will receive the combination of cetuximab plus S-1 (a combination of tegafur, gimeracil, and oteracil) and cisplatin.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cetuximab intervention 2: Cisplatin intervention 3: S-1
Intervention descriptions: intervention 1: Single first dose of cetuximab 400 milligram per square meter (mg/m\^2) will be administered intravenously followed by once weekly subsequent intravenous infusion of cetuximab 250 mg/m\^2 in each 5-week treatment cycle until disease progression, unacceptable toxicity, or withdrawal of consent. intervention 2: Cisplatin 60 mg/m\^2 will administered as intravenous infusion on Day 8 of each 5-week cycle maximum up to 8 cycles until disease progression, unacceptable toxicity, or withdrawal of consent intervention 3: S-1, a combination of tegafur, gimeracil, and oteracil will be administered intravenously at a dose of 40 to 60 mg/m\^2 orally twice daily for first three consecutive weeks of 5-week cycle until disease progression, unacceptable toxicity, or withdrawal of consent.

Protocol documents:
Clinical trial NCT01406938
Conditions: Moderate to Severe Plaque-type Psoriasis
Keywords: Psoriasis plaque inflammatory skin disease scaly patches AIN457 secukinumab Moderate to Severe Plaque-type Psoriasis
Sponsor: Novartis Pharmaceuticals
Start date: 2011-08-01; Completion date: 2013-05-01
Enrollment: 967 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of two different doses and two different dose regimens of subcutaneous secukinumab in patients that have moderate to severe, chronic, plaque-type psoriasis.

Detailed description:

Arms: arm 1: secukinumab 150 mg (1 injection per dose) and placebo to secukinumab 150 mg (1 injection per dose). Induction period only (IPO) arm 2: secukinumab- 2 x 150mg injections per dose arm 3: 1 s.c. secukinumab 150 mg injection + 1 s.c. PBO (placebo) secukinumab injection arm 4: 2 s.c. secukinumab 150 mg injections arm 5: 1 s.c. secukinumab 150 mg injection + 1 s.c. PBO secukinumab injection arm 6: 2 s.c. secukinumab 150 mg injections
Interventions: intervention 1: AIN457 150mg intervention 2: AIN457 300mg
Intervention descriptions: intervention 1: (1 injection per dose) and placebo to secukinumab 150 mg intervention 2: secukinumab 150 mg (2 injections per dose)

Protocol documents:
Clinical trial NCT01422213
Conditions: Major Depressive Disorder
Keywords: MDD Cognitive dysfunction
Sponsor: H. Lundbeck A/S
Start date: 2011-12-01; Completion date: 2013-05-01
Enrollment: 598 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Major Depressive Disorder (MDD) is a severe and common psychiatric disorder. Although MDD primarily involves mood disturbances, patients also usually present alterations in cognitive function (attention, memory, executive functioning and psychomotor speed). Even though antidepressants are suggested in the literature to potentially improve cognitive dysfunction in patients with MDD to some degree, there is a lack of adequate and well-controlled studies to investigate this effect. This study will evaluate the efficacy, safety and tolerability of a new antidepressant Vortioxetine versus placebo on cognitive dysfunction in adult patients with MDD.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Placebo intervention 2: Vortioxetine (Lu AA21004) intervention 3: Vortioxetine (Lu AA21004)
Intervention descriptions: intervention 1: capsules; daily; orally intervention 2: encapsulated tablets; daily; orally intervention 3: encapsulated tablets; daily; orally

Protocol documents:
Clinical trial NCT01425853
Conditions: Knee Osteoarthritis
Sponsor: Bioiberica
Start date: 2011-09-01; Completion date: 2013-05-01
Enrollment: 606 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the combination of Chondroitin sulfate (CS) and Glucosamine Hydrochloride (GH) has similar efficacy to Celecoxib (CE) in the treatment of patients with moderate to severe knee osteoarthritis (OA).

Detailed description:
The primary objective of this study is to show that the combination treatment CS/GH has comparable efficacy to CE in pain reduction from baseline to 6 months of treatment measured with the Western Ontario and McMaster Universities Arthritis Index (WOMAC) pain subscale in knee OA patients with moderate to severe pain.

Arms: arm 1: Active ingredients: Chondroitin sulfate, 200 mg and Glucosamine hydrochloride 250 mg.

Pharmacotherapeutic group: Other specific antirheumatic agents. Anatomical Therapeutic Chemical Classification System (ATC) code: M01CX. arm 2: Active ingredient: Celecoxib, 200 mg. Pharmacotherapeutic group: Coxibs. ATC code: M01AH.
Interventions: intervention 1: Chondroitin/Glucosamine (Droglican) intervention 2: Celecoxib
Intervention descriptions: intervention 1: Experimental intervention 2: Active comparator

Protocol documents:
Clinical trial NCT01428661
Conditions: Major Depressive Disorder
Keywords: tasimelteon Major Depressive Disorder MDD depression
Sponsor: Vanda Pharmaceuticals
Start date: 2011-09-01; Completion date: 2013-05-01
Enrollment: 507 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of an 8-week double-masked treatment of tasimelteon or placebo in male and female subjects with Major Depressive Disorder.

Detailed description:
This is a randomized, parallel, double-masked, placebo-controlled, multicenter outpatient study comparing tasimelteon with placebo in the treatment of subjects with Major Depressive Disorder (MDD).

The study has three phases: the pre-randomization phase, the randomization phase, and an open-label extension phase. The pre-randomization phase comprises a screening visit where subject's initial eligibility will be evaluated. The randomization phase is comprised of an 8-week double-masked segment. Subjects meeting all entry criteria for the study will enter the randomization phase. During this phase, subjects will be asked to take either 20 mg tasimelteon or placebo for 8 weeks in a double-masked fashion. At the end of the 8-week double-masked phase, those subjects who completed the 8-week treatment phase will be offered to enroll into a 52-week open-label extension where each subject will receive daily doses of 20 mg tasimelteon.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: tasimelteon intervention 2: placebo
Intervention descriptions: intervention 1: 20 mg once daily intervention 2: once daily

Protocol documents:
Clinical trial NCT01433016
Conditions: Chronic Liver Disease Hepatocellular Carcinoma (HCC)
Keywords: HCC Hepatocellular carcinoma OBT Octanoate Breath Test
Sponsor: Meridian Bioscience, Inc.
Start date: 2011-11-01; Completion date: 2013-05-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The Exalenz clinical investigation is a multicenter, non-randomized, study of the ¹³C-Octanoate Breath Test (OBT). The present study is a feasibility trial, which aims to evaluate the capability of the OBT measurement to differentiate between presence and absence of HCC determined by Magnetic Resonance Imaging (MRI) in patients with chronic liver disease.

Detailed description:
The Octanoate Breath Test (OBT) developed by Exalenz is performed by the BreathID System consists of the BreathID device and a test kit containing a nasal cannula, a calibration gas container and a non-radioactive isotope ¹³C- Octanoate solution, and measures and computes the ratio between ¹³CO2 and 12CO2 in the patient's exhaled breath.

This study's aim is to provide data on this novel system to dynamically and accurately assess liver function at the bed side. It is hoped that the system will provide prognostic information faster than is achieved at present with traditional methods. It is hypothesized that in the future the OBT may have an impact on decision making and clinical practice in this group of HCC patients, allowing a greater chance for proper management and hence survival.

Arms: arm 1: A Octanoate breath test will be performed on this single arm population
Interventions: intervention 1: 13C Sodium Octanoate
Intervention descriptions: intervention 1: 13C labeled Sodium Octanoate Substrate is provided in powder form in doses of 100mg for single breath test, and is dissolved in 150cc of tap water before ingestion. Duration of the observation after the drug ingestion is one hour.

Protocol documents:
Clinical trial NCT01446250
Conditions: Hepatitis C
Keywords: Chronic hepatitis C Cyclophilin inhibitor
Sponsor: Debiopharm International SA
Start date: 2011-12-01; Completion date: 2013-05-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety and efficacy of alisporivir (ALV) and boceprevir (BOC), each in combination with Peginterferon alfa-2a (PEG) and Ribavirin (RBV), in African American participants who have never received treatment for their chronic hepatitis C (HCV) genotype 1 infection.

Detailed description:

Arms: arm 1: At the time of partial clinical hold, participants randomized to original treatment arms A and B (Alisporivir triple therapy arms with Peginterferon alfa-2a and Ribavirin) discontinued alisporivir treatment immediately while continuing their treatments with the other two therapies. These participants were combined into the same arm because they received the same dose of alisporivir 400 mg twice per day (BID) for the same duration. Amendment 1 offered them the opportunity to continue in the study receiving boceprevir triple therapy. arm 2: Participants randomized to boceprevir triple therapy with Peginterferon alfa-2a and Ribavirin (the original treatment arm C).
Interventions: intervention 1: Alisporivir intervention 2: Boceprevir intervention 3: Peginterferon alfa-2a intervention 4: Ribavirin
Intervention descriptions: intervention 1: ALV 200 mg soft gel capsules administered orally intervention 2: BOC 800 mg (4 x 200 mg soft gel capsules) administered orally intervention 3: PEG 180 μg administered via subcutaneous (s.c.) injection once weekly intervention 4: RBV 200 mg tablets (weight-based dose: \< 75 mg = 1000 mg/day; ≥ 75 kg = 1200 mg/day) administered orally in a divided daily dose

Protocol documents:
Clinical trial NCT01458535
Conditions: Hepatitis C Virus
Keywords: Genotype 1 Genotype 2 Genotype 3 Hepatitis C Virus ABT-450/r Ribavirin ABT-267 Ombitasvir Paritaprevir
Sponsor: AbbVie (prior sponsor, Abbott)
Start date: 2011-09-01; Completion date: 2013-05-01
Enrollment: 61 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to evaluate the efficacy, safety and pharmacokinetics of ABT-450/r when given together with ABT-267 and with and without RBV in treatment-naïve participants with genotype 1, 2 or 3 chronic HCV infection.

Detailed description:
This was a 2 sequential arm, combination treatment study where each arm contained 3 cohorts: one each for HCV genotype 1, 2, and 3. The study consisted of 2 phases, a treatment phase and a post-treatment phase. The treatment phase was designed to explore the antiviral activity, safety and pharmacokinetics of ABT-450/r dosed in combination with ABT-267 with and without RBV for up to 12 weeks. The post-treatment phase was designed to monitor and evaluate Sustained Virologic Response (SVR) 12, SVR 24, and the evolution and persistence of viral resistance to ABT-267 and ABT-450 in HCV genotype 1-, 2-, and 3-infected participants who have been exposed to ABT-267 and ABT-450/r. Arms 1 and 2 were enrolled sequentially.

Arms: arm 1: ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided twice daily (BID) in treatment-naïve participants with HCV genotype 1 infection. arm 2: ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 2 infection. arm 3: ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD plus weight-based ribavirin (RBV) divided BID in treatment-naïve participants with HCV genotype 3 infection. arm 4: ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 1 infection. arm 5: ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 2 infection. arm 6: ABT-450/r (200/100 mg) once daily (QD) and ABT-267 (25 mg) QD in treatment-naïve participants with HCV genotype 3 infection.
Interventions: intervention 1: ABT-450 intervention 2: ABT-267 intervention 3: ribavirin intervention 4: ritonavir
Intervention descriptions: intervention 1: tablets intervention 2: tablets intervention 3: tablets intervention 4: capsules

Protocol documents:
Clinical trial NCT01470989
Conditions: Acute Gouty Arthritis Flares
Keywords: gouty arthritis
Sponsor: Novartis Pharmaceuticals
Start date: 2011-11-01; Completion date: 2013-05-01
Enrollment: 136 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any new gouty arthritis flare on demand with one subcutaneous (s.c.) injection of canakinumab 150 mg.

Detailed description:

Arms: arm 1: canakinumab 150 mg s.c.
Interventions: intervention 1: ACZ885 intervention 2: Triamcinolone acetonide 40 mg
Intervention descriptions: intervention 1: canakinumab 150 mg s.c., given on demand upon new flares intervention 2: Participants received 40 mg intramuscular (IM)

Protocol documents: