ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01753570
Conditions: Chronic Hepatitis C(CHC)
Keywords: Feron
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2012-12-01; Completion date: 2015-10-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy and safety of MP-424 with IFN beta and RBV in patients with genotype 1/2 hepatitis C, who are treatment-naïve or have received its treatment before.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: MP-424 intervention 2: RBV(24 weeks) intervention 3: IFN beta(24 weeks) intervention 4: RBV(48 weeks) intervention 5: IFN beta(48 weeks)
Intervention descriptions: intervention 1: MP-424: 750mg every 8 hours (q8h) for 12 weeks intervention 2: RBV: 600 - 1000mg/day based on body weight for 24 weeks intervention 3: IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 24 weeks intervention 4: RBV: 600 - 1000mg/day based on body weight for 48 weeks intervention 5: IFN beta: 600 MIU/day,6 days/week for initial 4 weeks following to 3 days/week for 48 weeks

Protocol documents:
Clinical trial NCT01774253
Conditions: Pontine Glioma
Keywords: DIPG
Sponsor: Giselle Sholler
Start date: 2013-05-01; Completion date: 2015-10-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to evaluate an investigational drug (Vismodegib) for Pontine Glioma that is growing or has come back (reoccurred). This study will look at the tumors response to the study drug, Vismodegib, and will also look at the safety and tolerability of Vismodegib.

Vismodegib has been tested in multiple adult clinical trials and one pediatric trial. Laboratory testing in pontine gliomas suggests that this drug may be effective in treating this disease.

Detailed description:

Arms: arm 1: Vismodegib will be dosed at 150mg-300mg orally (max dose: 300mg) once a day on days 1 to 28 of a 28-day cycle. In the absence of unacceptable toxicity or disease progression, treatment may continue for as long as tolerated.
Interventions: intervention 1: Vismodegib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01780974
Conditions: Treated Hypertension
Keywords: Hypertension Vascular Risk Alzheimer's Risk fish oil Lipoic acid
Sponsor: Oregon Health and Science University
Start date: 2013-04-01; Completion date: 2015-10-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of the pilot study is to provide data that can be used to better determine sample size for the design of a larger clinical trial. The pilot will evaluate the effectiveness of Lipoic Acid (LA) plus Omega-3 fatty acids (Omega-3) on preventing Alzheimer's Disease (AD). The investigators will also collect data to evaluate recruitment rate, safety, and compliance over the 12 month study period.

Detailed description:
The primary aim is to collect data so that we can determine effect size between lipoic acid plus omega-3 fatty acids and placebo on the primary outcome measure Trails B (executive function). This is designed as a pilot randomized, double-blind, placebo-controlled study with a 12 month intervention period. Thirty participants diagnosed with hypertension that is treated (systolic blood pressure 90-160 mm Hg, diastolic blood pressure 60-90 mm Hg) that have low omega-3 fatty acid levels, and normal cognitive function will be randomized to receive study drug or placebo.

Arms: arm 1: Three placebo oil capsules per day (2 caps morning, 1 cap evening) + 2 placebo LA capsules per day. Capsules will be taken with food or a meal. arm 2: Three 1-gram fish oil concentrate capsules per day (2 caps morning, 1 cap evening) containing a daily dose of 675 mg docosahexaenoic acid (DHA) and 975 mg eicosapentaenoic acid (EPA) plus 2 LA capsules per day with a daily dose of 600 mg. Capsules will be taken with food or a meal.
Interventions: intervention 1: Lipoic Acid plus Omega-3 Fatty Acids intervention 2: Placebo
Intervention descriptions: intervention 1: alpha lipoic acid (racemic) and fish oil concentrate intervention 2: placebo capsules

Protocol documents:
Clinical trial NCT01783054
Conditions: Adenocarcinoma Pancreas
Keywords: NEOADJUVANT GEMCITABINE AND ABRAXANE CHEMOTHERAPY SURGERY RESECTABLE ADENOCARCINOMA OF THE PANCREAS
Sponsor: Medical University of South Carolina
Start date: 2012-07-01; Completion date: 2015-10-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is for adult patients with adenocarcinoma of the pancreas. The purpose of this research study is to evaluate the safety and effectiveness of the drugs Gemcitabine and Abraxane in the treatment of adenocarcinoma of the pancreas before surgery. Subjects will have screening tests to determine if he or she is eligible to participate in this study.

Detailed description:
If subjects are eligible and wish to enroll in the study, they will begin chemotherapy treatment with Gemcitabine and Abraxane. After subjects have received treatment with these drugs, they will have surgery. Subjects will also have post treatment and follow up evaluations. Subjects may have 2 cycles of treatment and each cycle is 28 days. All subjects will be followed every 3 months for 3 years after their initial registration.

Arms: arm 1: All patients enrolled on study will start study treatment on a chemotherapy treatment regimen of Gemcitabine and abraxane. Treatment will be given on days 1, 8 and 15 of each cycle for 2 cycles over the course of 12 weeks.

Patients will move on to surgery, 4-8 weeks after chemotherapy treatment. Patients must be recovered from any adverse effects of the chemotherapy before proceeding with surgery.

As part of this study, tissue samples will be collect from each patient at the time of surgery for gene expression testing
Interventions: intervention 1: Surgery intervention 2: Genetic Expression intervention 3: Chemotherapy
Intervention descriptions: intervention 1: Subjects will then receive surgery at MUSC within 4-8 weeks following completion of chemotherapy intervention 2: Subjects will have genetic expression testing done on their tissue samples. intervention 3: Patients will receive gemcitabine at 1000 mg/m2 and abraxane at 125 mg/m2 intravenously on days 1, 8 and 15 of a 28 day cycle for 2 cycles

Protocol documents:
Clinical trial NCT01823328
Conditions: Airway Control Anesthesia Intubation Complication
Keywords: Intubation Airway Emergent intubation Rapid sequence intubation Rapid sequence induction RSI Ketamine Etomidate Sepsis Sedative Sedation
Sponsor: Hennepin Healthcare Research Institute
Start date: 2013-09-01; Completion date: 2015-10-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the effectiveness and safety of ketamine and etomidate during rapid sequence intubation (RSI).

Detailed description:
This study is a randomized controlled trial of etomidate versus ketamine during rapid sequence intubation (RSI). RSI refers to the process by which patients who require emergency airway management undergo sedation and paralysis prior to insertion of an endotracheal tube(airway tube). Patients who require intubation will be randomized to have intubation performed with either ketamine or etomidate. All other care will be at the discretion of the treating physicians. The purpose of this study is to compare the efficacy and safety of ketamine and etomidate during rapid sequence intubation.

Arms: arm 1: Subjects in the ketamine arm will receive ketamine for sedation prior to rapid sequence intubation (RSI). arm 2: Subjects in the etomidate arm will receive etomidate for sedation prior to rapid sequence intubation (RSI).
Interventions: intervention 1: Ketamine intervention 2: Etomidate
Intervention descriptions: intervention 1: Subjects will receive ketamine for sedation prior to rapid sequence intubation. intervention 2: Subjects will receive etomidate for sedation prior to rapid sequence intubation.

Protocol documents:
Clinical trial NCT01825798
Conditions: Overweight Autism Spectrum Disorder
Keywords: Metformin Overweight Atypical Antipsychotic Medication Randomized Clinical Trial Children
Sponsor: Holland Bloorview Kids Rehabilitation Hospital
Start date: 2013-04-01; Completion date: 2015-10-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether metformin is safe and effective in the treatment of weight or weight gain in young people with Autism Spectrum Disorders (ASD) who are currently taking atypical antipsychotic medication.

Detailed description:
This is a double-blind, placebo-controlled, multi-site randomized trial to evaluate oral fixed dose metformin (Riomet®) in decreasing weight or weight gain in children ages 6-17 years, 4 months with ASD who are currently taking atypical antipsychotic medication. A 16-week, double-blind, placebo-controlled randomized trial of metformin with dose guided by age will be conducted. A secondary study aim will be to assess the long-term safety and efficacy of metformin by conducting a 16-week open label continuation.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: Metformin will be dispensed in a liquid suspension of 100 mg/mL. For children 6-9 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, metformin will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if metformin is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if metformin is well-tolerated, the dose will be increased to 850 mg twice daily. intervention 2: The placebo hydrochloride oral solution will be prepared to match the appearance, smell and taste of the metformin as closely as possible. For children from 6-9 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. For children from 10-17 years of age, placebo will be started at 250 mg at their evening meal for 1 week, followed by the addition of a 250 mg dose at breakfast for 1 week. At the Week 2 visit, if placebo is well-tolerated, the dose will be increased to 500 mg twice daily. At the Week 4 visit, if placebo is well-tolerated, the dose will be increased to 850 mg twice daily.

Protocol documents:
Clinical trial NCT01844778
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis, Pseudomonas aeruginosa, FEV1, tobramycin inhalation powder, TOBI, colistimethate Cystic Fibrosis, Pseudomonas aeruginosa, FEV1, tobramycin inhalation powder, TOBI, colistimethate
Sponsor: Novartis Pharmaceuticals
Start date: 2013-08-01; Completion date: 2015-10-01
Enrollment: 60 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this interventional Phase IV study was to explore the ease of use of TIP and prevalence of microbial contamination of the T-326 Inhaler compared with TIS and colistimethate administered via nebuliser for the treatment of Cystic Fibrosis (CF) patients chronically infected with P. aeruginosa.

It was anticipated that the data from this study would provide clinicians with further guidance on the relative differences between the speed and ease of use of these treatments as well as useful information on the prevalence of microbial contamination of the inhalation devices in "real world" use.

Detailed description:
Patients who were on colistimethate (COLI), Tobramycin Inhalation Powder (TIP) or Tobramycin Inhalation Solution (TIS) were recruited for the study. They went through one treatment cycle on their usual inhaled antibiotic treatment, and were all transferred to TIP for the second treatment cycle. The primary endpoint was the total administration time of TIP vs TIS vs colistimethate, defined as the total time taken to prepare the delivery device and drug, administer the drug, and clean and disinfect the delivery device.

Arms: arm 1: During the first cycle of treatment, participants received nebulized TIS, 300 mg twice per day for 28 days followed by 28 days off-treatment. During the second cycle, participants received 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment. arm 2: During the first cycle, participants received nebulized COLI, 1 million or 2 million units twice or thrice per day (or the participant's usual dose and regimen) for 56 days (no off-treatment period) or 28 days on-treatment followed by 28 days off-treatment (cycling regimen), depending on local treatment guidelines. During the second cycle, participants received TIP, 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment. arm 3: During the first and second cycles, participants received TIP, 112 mg (four 28 mg capsules) twice per day for 28 days followed by 28 days off-treatment.
Interventions: intervention 1: Tobramycin Inhalation Powder intervention 2: Tobramycin inhalation solution intervention 3: Colistimethate
Intervention descriptions: intervention 1: Tobramycin Inhalation Powder was administered via TOBI® Podhaler (T-326 inhaler). intervention 2: Tobramycin inhalation solution was administered via nebuliser intervention 3: Colistimethate was administered via nebuliser.

Protocol documents:
Clinical trial NCT01867307
Conditions: Diabetes Mellitus, Type 2 Healthy
Sponsor: Boehringer Ingelheim
Start date: 2013-06-01; Completion date: 2015-10-01
Enrollment: 39 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Single center, 14-day, open-label trial to examine the effect of 25 mg q.d. empagliflozin on kinetics of renal glucose reabsorption in patients diagnosed with type 2 diabetes mellitus and healthy controls

Detailed description:

Arms: arm 1: healthy controls arm 2: patients with type 2 diabetes mellitus
Interventions: intervention 1: Empagliflozin intervention 2: BI 10773
Intervention descriptions: intervention 1: None intervention 2: open label

Protocol documents:
Clinical trial NCT01895309
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis Etanercept Biosimilar
Sponsor: Samsung Bioepis Co., Ltd.
Start date: 2013-06-01; Completion date: 2015-10-01
Enrollment: 596 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, parallel group, multicentre clinical study to evaluate the efficacy, safety, pharmacokinetics and immunogenicity of SB4 compared to Enbrel in subjects with moderate to severe Rheumatoid Arthritis (RA) despite Methotrexate (MTX) therapy. In some countries, after 52 weeks of treatment with either SB4 or Enbrel, subjects will be enrolled into an open label extension period. Subjects will receive SB4 for an additional 48 weeks.

Detailed description:

Arms: arm 1: SB4 50 mg/week via subcutaneous injection arm 2: Enbrel 50 mg/week via subcutaneous injection
Interventions: intervention 1: Enbrel (etanercept) intervention 2: SB4 (proposed biosimilar to etanercept)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01896297
Conditions: Atrial Fibrillation
Sponsor: Boehringer Ingelheim
Start date: 2013-07-01; Completion date: 2015-10-01
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this study is to assess dabigatran pharmacokinetics in NVAF subjects with severe renal impairment defined as creatinine clearance between 15 and 30 mL/min calculated by Cockcroft-Gault formula.

The dabigatran etexilate dose of 75 mg BID was approved by the FDA for NVAF patients with severe renal impairment (CrCl 15-30 mL/min) , based on pharmacokinetic modeling and simulation.

Detailed description:

Arms: arm 1: 75mg BID by oral
Interventions: intervention 1: Pradaxa, dabigatran etexilate
Intervention descriptions: intervention 1: 75mg BID by oral

Protocol documents:
Clinical trial NCT01897233
Conditions: Cystic Fibrosis
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2013-07-01; Completion date: 2015-10-01
Enrollment: 62 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 3, 2-part (Part A and Part B), open-label, multicenter study to evaluate the pharmacokinetics, safety, and tolerability of lumacaftor in combination with ivacaftor in subjects with cystic fibrosis aged 6 to 11 years who have the F508del-mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene.

Detailed description:

Arms: arm 1: Part A Cohort 1: Participants aged 6 through 8 years will receive LUM 200 milligram (mg) in fixed-dose combination with IVA 250 mg orally every 12 hours (q12h) for 14 days.

Part A Cohort 2: Participants aged 9 through 11 years will receive LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 14 days.

Part B: Participants aged 6 through 11 years will receive LUM 200 mg in fixed-dose combination with IVA 250 mg orally q12h for 24 weeks.
Interventions: intervention 1: Lumacaftor intervention 2: Ivacaftor
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01928433
Conditions: Urinary Tract Infections Acute Pyelonephritis
Keywords: Urinary Tract Infection Pyelonephritis
Sponsor: MerLion Pharmaceuticals GmbH
Start date: 2012-12-01; Completion date: 2015-10-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to evaluate the microbiological and clinical outcome of treatment with finafloxacin for 5 days versus finafloxacin for 10 days versus ciprofloxacin for 10 days as a reference comparator.

Finafloxacin shows increased activity in an acidic environment which is associated with indications such as uUTI and cUTI. Given the acidic pH of urine and concentration of finafloxacin excreted via the urinary tract in humans it should be proven if the finafloxacin treatments offer significant advantages over the currently available treatments for UTI.

Detailed description:
Fluoroquinolones are frequently prescribed for complicated Urinary Tract Infections (cUTI) and pyelonephritis, due to their activity against cUTI pathogens and high levels of excretion in the urine following oral and i.v. administration. However, many currently prescribed fluoroquinolones exhibit reduced antibacterial activity at low pH, which suggests reduced activity in infected urinary tracts.

Arms: arm 1: Intervention:

Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 5 days. arm 2: Intervention:

Finafloxacin 800 mg i.v. once daily and Ciprofloxacin placebo i.v. twice daily. Finafloxacin 800 mg tablets once daily and Ciprofloxacin placebo oral twice daily Finafloxacin verum (i.v. and oral) for a total of 10 days. arm 3: Intervention:

Ciprofloxacin 400 mg i.v. twice daily and Finafloxacin placebo i.v. once daily Ciprofloxacin 500 mg oral twice daily and Finafloxacin placebo tablets once daily Ciprofloxacin (i.v. and oral) for a total of 10 days.
Interventions: intervention 1: Finafloxacin 800 mg i.v. once daily intervention 2: Finafloxacin placebo i.v. once daily intervention 3: Finafloxacin 800 mg tablets once daily intervention 4: Finafloxacin placebo tablets once daily intervention 5: Ciprofloxacin 400 mg i.v. twice daily intervention 6: Ciprofloxacin placebo i.v. twice daily intervention 7: Ciprofloxacin 500 mg oral twice daily intervention 8: Ciprofloxacin placebo oral twice daily
Intervention descriptions: intervention 1: Infused over 60 mins \[i.v. pump\]) for at least 3 days. intervention 2: Infused over 60 mins \[i.v. pump\]) for at least 3 days. intervention 3: Administered as four 200 mg tablets intervention 4: Administered as four tablets intervention 5: Infused over approximately 60 mins \[i.v. pump\]) for at least 3 days intervention 6: Infused over approximately 60 mins \[i.v. pump\]) for at least 3 days intervention 7: Administered as two 250 mg capsules. intervention 8: Administered as two capsules.

Protocol documents:
Clinical trial NCT01944319
Conditions: Lower Respiratory Tract Infection
Keywords: Infection; Meropenem; Pharmacokinetics; Pharmacodynamics
Sponsor: Qingtao Zhou
Start date: 2013-07-01; Completion date: 2015-10-01
Enrollment: 79 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the clinical and economical benefits of a meropenem dosage strategy based on a population pharmacokinetic(PPK)-pharmacodynamic(PD) model in lower respiratory tract infection patients.

Detailed description:
* Subjects:lower respiratory tract infection patients
* Study design:randomized control study.The patients in study group will accept meropenem therapy with the regimen decided by a software developed from a PPK-PD model. The patients in control group will accept meropenem therapy with the regimen decided by attending physician.
* Primary endpoint: clinical successful rate of meropenem therapy. The clinical efficiency of meropenem therapy will be evaluated one week later from stop of meropenem therapy.
* Second endpoint: amount of used antibiotics and bacteriological successful rate.

Arms: arm 1: The participants in control group will accept routine meropenem therapy arm 2: The participants in study group will accept meropenem therapy based on a PPK and PD model.
Interventions: intervention 1: Routine meropenem therapy intervention 2: Meropenem therapy based on a PPK and PD model
Intervention descriptions: intervention 1: Participants in control group will accept meropenem therapy with regimen routinely decided by attending physician intervention 2: Participants in study group will accept meropenem therapy based on a software developed from a PPK and PD model

Protocol documents:
Clinical trial NCT01966718
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid arthritis Joint pain Repository corticotropin injection
Sponsor: Arthritis Treatment Center, Maryland
Start date: 2013-10-01; Completion date: 2015-10-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
It is hypothesized that repository corticotropin injection in combination with other biologic agents will be able to provide relief of both rheumatoid arthritis and acute exacerbations of rheumatoid arthritis for patients with disease that had inadequately responded to biologics previously.

Detailed description:
Although there are many types of treatment for rheumatoid arthritis (RA) currently available, some patients have disease that is refractory to treatment and cannot achieve remission. The objective of this study is to assess the efficacy and safety of subcutaneous injections of repository corticotropin as an adjunct therapy in patients with active RA who have had an inadequate response to at least two biologic agents as well as a third agent they are currently receiving.

Arms: arm 1: Repository corticotropin injection, 80 United States Pharmacopeia (USP) Units per mL, dosed as 1 mL (80 Units) subcutaneous injection every 72 hours for 12 weeks
Interventions: intervention 1: Repository corticotropin injection
Intervention descriptions: intervention 1: An adrenocorticotropic hormone (ACTH) analogue that stimulates the adrenal cortex to secrete cortisol, corticosterone, aldosterone, and a number of weakly androgenic substances

Protocol documents: