ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01715129
Conditions: Prostate Cancer
Sponsor: Ipsen
Start date: 2013-01-01; Completion date: 2013-10-01
Enrollment: 126 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Assess the efficacy and safety of Triptorelin pamoate 3M formulation (11.25mg) when administered by subcutaneous route.

Detailed description:

Arms: arm 1: 11.25mg, SC on Day 1 and Day 92
Interventions: intervention 1: Triptorelin Pamoate 11.25mg
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01717209
Conditions: Heart Failure
Keywords: heart failure hypertension, pulmonary heart failure, right-sided heart-assist devices Heart Transplantation
Sponsor: Stanford University
Start date: 2012-10-01; Completion date: 2013-10-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Research study evaluating the individual and combined effects of inhaled nitric oxide (iNO) and inhaled prostacyclin (iPGI2), on the function of the right heart after surgery for either heart transplant or for left ventricular assist device (LVAD) placement. The investigators hope to learn if these two medications, when given together after surgery, improve right heart function by lowering blood vessel pressures in the lungs. The investigators hope to learn if the combined effects of these two medications are better than either medication used alone. Participants were selected as a possible participant in this study because right heart problems are common during and after surgery for heart transplant and for LVAD placement. In addition, iNO is always given during and after these two types of surgeries at Stanford to help improve how the right heart functions.

Detailed description:
The study will begin once the participant arrives in the cardiothoracic intensive care unit (CTICU) after heart surgery for either heart transplant or LVAD placement. As is standard of care after these types of surgeries, the participant will arrive in the CTICU with a breathing tube already in place, receiving iNO, and connected to a breathing machine. The participant will be receiving relaxing medication in an intravenous line provided by the cardiac anesthesiologist and the CTICU physicians. The participant will be unaware of the study period while the participant is sedated. Data will be collected from the monitor screen connected to the participant's arterial and venous lines, and if placed, LVAD monitor. These data are:

Central venous pressure (CVP) Mean arterial pressure (MAP) Mean pulmonary artery pressure (MPAP) Cardiac Index (CI) Systemic vascular resistance (SVR) Pulmonary vascular resistance (PVR) Right ventricular stroke work index (RVSWI) LVAD Flow LVAD Pulsatility Index (PI)

These data will be collected at five different time periods during the first eight hours after surgery.

1. Time zero. Data will be collected after surgery upon your arrival to the CTICU while receiving iNO.
2. After two hours of iNO treatment data will be collected. iPGI2 will then be combined with the current iNO.
3. After two hours of combined iNO and iPGI2 treatment, data will be collected. iNO will then be stopped.
4. After two hours of iPGI2 treatment data will be collected. iNO will be restarted.
5. After two hours of combined iNO and iPGI2 treatment, data will be collected. The study ends after this data collection time.

Arms: arm 1: iNO (20 ppm continuously) and iPGI2 (0.05 micrograms/kg/min continuously)
Interventions: intervention 1: Nitric Oxide intervention 2: Prostacyclin
Intervention descriptions: intervention 1: inhaled nitric oxide intervention 2: inhaled prostacyclin

Protocol documents:
Clinical trial NCT01720069
Conditions: Asthma
Sponsor: Vectura Limited
Start date: 2012-10-01; Completion date: 2013-10-01
Enrollment: 197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the clinical efficacy, safety, tolerability and dose-response relationship, using oral corticosteroid (OCS) modulation, of 3 different doses of VR506 using a twice daily regimen from a new dry powder inhaler (nDPI) for 16 weeks in subjects with severe persistent asthma requiring OCS therapy, i.e. Step 5 treatment as defined by modified Global Initiative for Asthma (GINA) guidelines 2011.

Detailed description:

Arms: arm 1: VR506 inhalation powder delivered via a new dry powder inhaler device arm 2: VR506 inhalation powder delivered via a new dry powder inhaler device arm 3: VR506 inhalation powder delivered via a new dry powder inhaler device
Interventions: intervention 1: VR506
Intervention descriptions: intervention 1: VR506 inhalation powder delivered via a new dry powder inhaler device

Protocol documents:
Clinical trial NCT01724528
Conditions: Tumor Lysis Syndrome
Keywords: Febuxostat, Tumor lysis syndrome, leukemia, lymphoma
Sponsor: Menarini Group
Start date: 2012-10-01; Completion date: 2013-10-01
Enrollment: 346 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether febuxostat is superior to allopurinol in the prevention of tumor lysis syndrome (TLS) in patients with hematological malignancies at intermediate or high risk of TLS (according to Cairo-Bishop classification) who undergo chemotherapy

Detailed description:
This study is designed as a randomised, double-blind, active-controlled, parallel-group study to be conducted in approximately 80 sites.

Approximately 340 male or female patients aged 18 or older suffering from hematologic malignancies (de novo patients or relapsing patients) at intermediate to high risk of TLS and scheduled for receiving the first cycle of cytotoxic chemotherapy, regardless of the line of treatment, will be randomized in this study. Eligible patients (as per screening visit) will be randomly allocated in a 1:1 ratio to Febuxostat or Allopurinol. The double-blind treatment period starts two days prior to the planned beginning of chemotherapy and continues for 7 to 9 consecutive days, according to Investigator judgment and on the basis of the actual duration of chemotherapy regimen administered to the patient. Along the study treatment, uric acid levels, creatinine levels, Laboratory TLS/Clinical TLS and Adverse Events represent the major clinical findings to be monitored on a daily basis. Overall the study encompasses 10 to 11 planned visits at site, including screening, randomisation, on treatment and final follow up visits.

Arms: arm 1: Febuxostat for 7-9 days arm 2: Allopurinol for 7-9 days
Interventions: intervention 1: Febuxostat intervention 2: Allopurinol
Intervention descriptions: intervention 1: Standard dose PO (per os) from Day 1 to Day 7 (can be continued up to DAY 9 at investigator's discretion) intervention 2: Standard dose, low dose or high dose (as per investigator's judgement at the time of randomization) from DAY 1 to DAY 7 (can be continued up to DAY 9 at investigator's discretion)

Protocol documents:
Clinical trial NCT01732471
Conditions: Phenylketonuria
Keywords: EMR 700733_510, Genetic disorder, Phenylketonuria, phenylalanine, Kuvan, sapropterin dihydrochloride
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2012-11-01; Completion date: 2013-10-01
Enrollment: 90 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, non-comparative, Phase 3 study to evaluate the degree, frequency of response and safety of Kuvan® (sapropterin dihydrochloride) in subjects aged 4 to 18 years who have phenylketonuria and with elevated blood phenylalanine level of greater than or equal to 450 micromole per liter.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Kuvan®
Intervention descriptions: intervention 1: Kuvan® (sapropterin dihydrochloride) will be administered orally at a dose of 20 milligram per kilogram per day (mg/kg/day) once daily for 8 days. If there is 30 percent (%) decrease in blood phenylalanine levels from baseline at the end of Day 8, then treatment will be continued at the same dose for further 6 weeks.

Protocol documents:
Clinical trial NCT01743729
Conditions: Dry Eye Disease
Keywords: SAR 1118
Sponsor: Shire
Start date: 2012-12-07; Completion date: 2013-10-01
Enrollment: 720 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the safety and efficacy of lifitegrast ophthalmic solution compared to placebo in the treatment of dry eye.

Detailed description:

Arms: arm 1: Lifitegrast Ophthalmic Solution (5.0%) arm 2: None
Interventions: intervention 1: Lifitegrast intervention 2: Placebo
Intervention descriptions: intervention 1: Lifitegrast Ophthalmic Solution 5.0% intervention 2: Placebo for Lifitegrast Ophthalmic Solution 5.0%

Protocol documents:
Clinical trial NCT01764854
Conditions: End Stage Renal Disease Chronic Kidney Disease Stage 5 ESRD
Keywords: Hemodialysis
Sponsor: Ardelyx
Start date: 2013-01-01; Completion date: 2013-10-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing fluid overload/weight gain between dialysis sessions for patients with End Stage Renal Disease on Hemodialysis.

Detailed description:
This is a Phase 2, multi-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of the study drug in male and female patients with end-stage renal disease on hemodialysis. The study consists of a 2 week treatment-free run-in period where entry criteria are verified, a 4-week treatment period, of which the first week of treatment will be performed as an in-patient study in a clinical pharmacology unit (CPU) and the remaining three weeks of treatment will performed as an out-patient study, and a 2-week treatment-free follow-up period.

Safety assessments will be performed at regular intervals and will include clinical and vital signs, clinical laboratory evaluations, ECGs, and AE monitoring. Pharmacodynamic assessments will include, but are not limited to, interdialytic weight gain (IDWG), blood pressure, and stool sodium excretion. Pharmacokinetic assessments will include blood sampling for measurement of study drug plasma concentrations.

Arms: arm 1: Tenapanor administered in a clinical pharmacology unit arm 2: Placebo (size and color matched to experimental drug) administered in a clinical pharmacology unit arm 3: Tenapanor arm 4: Placebo
Interventions: intervention 1: AZD1722 (in-patient) intervention 2: Placebo (in-patient) intervention 3: AZD1722 (out-patient) intervention 4: Placebo
Intervention descriptions: intervention 1: doses between 5 and 60 mg BID may be administered based on tolerability in a CPU setting intervention 2: Placebo, size and color matched to experimental drug administered in a CPU intervention 3: doses between 5 and 45 mg BID intervention 4: Placebo, size and color matched to experimental drug

Protocol documents:
Clinical trial NCT01765192
Conditions: Asthma
Keywords: Drug therapy
Sponsor: AstraZeneca
Start date: 2013-02-01; Completion date: 2013-10-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the effect of roflumilast 500 μg once daily (QD) plus montelukast 10 mg QD versus 10 mg montelukast QD alone on predose (trough) prebronchodilator forced expiratory volume in the first second (FEV1).

Detailed description:
The drug being tested in this study is called roflumilast. Roflumilast is being tested to treat people who have asthma. This study will look at lung function and asthma symptoms of people who take roflumilast in combination with montelukast.

Arms: arm 1: Participants in sequence 1 received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received placebo plus montelukast 10 mg orally once daily for 4 weeks. arm 2: Participants in sequence 2 received placebo plus montelukast 10 mg orally once daily for 4 weeks followed by a 4-week washout period and then received roflumilast 500 μg plus montelukast 10 mg orally once daily for 4 weeks.
Interventions: intervention 1: Roflumilast intervention 2: Roflumilast placebo intervention 3: Montelukast
Intervention descriptions: intervention 1: Roflumilast was supplied in tablets. intervention 2: Roflumilast placebo was supplied in tablets. intervention 3: Montelukast was supplied in tablets.

Protocol documents:
Clinical trial NCT01769365
Conditions: Helicobacter Pylori Infection
Keywords: Helicobacter pylori infection
Sponsor: Kaohsiung Veterans General Hospital.
Start date: 2010-07-01; Completion date: 2013-10-01
Enrollment: 307 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To simultaneously compare the efficacies of 7-day triple, 10-day sequential and 7-day quadruple therapies for H. pylori infection in Taiwan. Consecutive H. pylori-infected patients were randomly assigned to a 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), a 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) or a 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days). The end point is to evaluate the effectiveness of Helicobacter pylori eradication rates between three groups.

Detailed description:
The purpose of this study is to compare the effectiveness of three H. pylori eradication regimens: 7-day standard triple therapy (pantoprazole, clarithromycin, and amoxicillin for 7 days), 10-day sequential therapy (pantoprazole and amoxicillin for 5 days, followed by pantoprazole, clarithromycin and metronidazole for a further 5 days) and 7-day quadruple therapy (pantoprazole, clarithromycin, amoxicillin and metronidazole for 7 days) in Taiwan.

A total of 306 subjects are enrolled into this study.

H. pylori-infected patients are randomized to a 7-day standard triple therapy, a 10-day sequential therapy, or a 7-day quadruple therapy. Eradication efficacy is assessed by a follow-up endoscopy with rapid urease test and histological examination eight weeks after the H. pylori therapy. The eradication rates of three groups will be compared.

Arms: arm 1: 1. pantoprazole 40 mg twice daily for 7 days,
2. clarithromycin 500 mg twice daily for 7 days,
3. amoxicillin 1 g twice daily for 7 days,
4. metronidazole 500 mg twice daily for 7 days arm 2: 1. pantoprazole 40 mg twice daily for 5 days and amoxicillin 1 g twice daily for 5 days, followed by
2. pantoprazole 40 mg twice daily for 5 days, clarithromycin 500 mg twice daily for 5 days, metronidazole 500 mg twice daily for 5 days. arm 3: 1. pantoprazole 40 mg twice daily for 7 days,
2. clarithromycin 500 mg twice daily for 7 days,
3. amoxicillin 1 g twice daily for 7 days.
Interventions: intervention 1: 7-day quadruple therapy intervention 2: 10-day sequential therapy intervention 3: 7-day standard triple therapy
Intervention descriptions: intervention 1: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily and metronidazole 500 mg twice daily for 7 days intervention 2: pantoprazole 40 mg twice daily and amoxicillin 1 g twice daily for 5 days, followed by pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily and metronidazole 500 mg twice daily for a further 5 days intervention 3: pantoprazole 40 mg twice daily, clarithromycin 500 mg twice daily, and amoxicillin 1 g twice daily for 7 days

Protocol documents:
Clinical trial NCT01783548
Conditions: Allergic Rhinitis
Keywords: allergic rhinitis pediatric subjects BDP nasal aerosol
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2013-01-01; Completion date: 2013-10-01
Enrollment: 547 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy and safety of Beclomethasone dipropionate (BDP) nasal aerosol in subjects with Perennial Allergic Rhinitis (PAR).

Detailed description:

Arms: arm 1: BDP nasal aerosol: 80 mcg dose once daily in the morning. Participants/parents administer 40 mcg BDP (one spray per nostril) during the 12-week Treatment Period. arm 2: Placebo nasal aerosol: Participants/parents administer placebo (no medication) (one spray per nostril) once daily in the morning during the 12-week Treatment Period.
Interventions: intervention 1: BDP Nasal Aerosol intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01787188
Conditions: Osteoarthritis
Sponsor: Iroko Pharmaceuticals, LLC
Start date: 2013-02-01; Completion date: 2013-10-01
Enrollment: 403 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether Meloxicam \[Test\] Capsules are safe and effective for the treatment of osteoarthritis pain of the knee or hip.

Detailed description:

Arms: arm 1: Meloxicam Test Capsules low dose QD arm 2: Meloxicam Test Capsules high dose QD arm 3: Placebo Capsule QD
Interventions: intervention 1: Meloxicam Test Capsules intervention 2: Meloxicam Test Capsules intervention 3: Placebo Capsules
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01789775
Conditions: Rosacea
Sponsor: Galderma R&D
Start date: 2012-12-01; Completion date: 2013-10-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with rosacea

Detailed description:

Arms: arm 1: Placebo arm 2: Intervention: Drug: CD07805/47 gel
Interventions: intervention 1: Drug: CD07805/47 gel intervention 2: CD07805/47 gel Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01819922
Conditions: Healthy
Keywords: Cardiopulmonary exercise testing metabolic parameters Diabetes Mellitus Type 2
Sponsor: Pfizer
Start date: 2013-04-01; Completion date: 2013-10-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study is designed to assess the effect of one single dose of PF-05175157 on metabolic and cardiopulmonary parameters before, during and after treadmill exercise in healthy volunteers.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PF-05175157 intervention 2: Placebo
Intervention descriptions: intervention 1: 600 mg as powder in capsule, one dose within 5 minutes prior to AM meal intervention 2: Placebo powder in capsule, one dose within 5 minutes prior to AM meal

Protocol documents:
Clinical trial NCT01825889
Conditions: Cardiovascular Disease
Sponsor: Eli Lilly and Company
Start date: 2013-04-01; Completion date: 2013-10-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to measure how much of the study drug, evacetrapib, enters the blood stream and how long it takes the body to dispose of the study drug when given to participants with severe renal (kidney) impairment compared to participants with normal renal (kidney) function. This study will last approximately 8 weeks.

Detailed description:

Arms: arm 1: Single oral dose of 130 milligrams (mg) evacetrapib on Day 1 to participants with severe renal impairment. arm 2: Single oral dose of 130 mg evacetrapib on Day 1 to participants with normal renal function.
Interventions: intervention 1: Evacetrapib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01836185
Conditions: Hepatic Insufficiency
Sponsor: Eli Lilly and Company
Start date: 2013-04-01; Completion date: 2013-10-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to measure how much of the drug gets into the bloodstream and how long it takes the body to remove it when given to participants with hepatic (liver) impairment compared to participants with normal hepatic function. Information about any side effects that may occur will also be collected. This study will last approximately 28 days, not including screening.

Detailed description:

Arms: arm 1: Group 1: 130 milligrams (mg) evacetrapib administered once, orally, to participants with normal hepatic function arm 2: Group 2: 130 mg evacetrapib administered once, orally, to participants with mild hepatic impairment arm 3: Group 3: 130 mg evacetrapib administered once, orally, to participants with moderate hepatic impairment arm 4: Group 4: 130 mg evacetrapib administered once, orally, to participants with severe hepatic impairment
Interventions: intervention 1: Evacetrapib
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01839331
Conditions: Osteoarthritis of the Knee
Keywords: osteoarthritis osteoarthritis of the knee
Sponsor: Ampio Pharmaceuticals. Inc.
Start date: 2013-03-29; Completion date: 2013-10-01
Enrollment: 329 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of two doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Detailed description:
A Randomized, Placebo-controlled, Double-Blind Study to Evaluate the Efficacy and Safety of two Doses of Intra-Articular Injection of Ampion™ in Adults with pain due to osteoarthritis of the knee.

The primary trial objective is to evaluate whether there is greater efficacy of 10 mL Ampion™ versus 10 mL placebo than 4 mL Ampion™ versus 4 mL placebo intra-articular (IA) injection in improving knee pain, when applied to patients suffering from OA of the knee.

The secondary trial objective include: the evaluation of the safety of an intra-articular injection of Ampion™ when applied to patients suffering from OA of the knee, evaluation of the efficacy of intra-articular injection of Ampion™ and placebo on stiffness and function when applied to patients suffering from OA of the knee and evaluation of responder status defined by the Outcome Measures in Rheumatology Clinical Trials and Osteoarthritis Research Society International (OMERACT-OARSI) Criteria.

Arms: arm 1: 4 mL Injection of Ampion arm 2: 4 mL Injection of Placebo arm 3: 10 mL Injection of Ampion arm 4: 10 mL Injection of Placebo
Interventions: intervention 1: 4 mL injection of Ampion intervention 2: 10 mL Injection of Ampion intervention 3: 4 mL Injection of Placebo intervention 4: 10 mL Injection of Placebo
Intervention descriptions: intervention 1: 4 mL Injection of Ampion intervention 2: 10 mL Injection of Ampion intervention 3: 4 mL Injection of Placebo intervention 4: 10 mL Injection of Placebo

Protocol documents: