ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02202135
Conditions: Complicated Skin and Soft Tissue Infection
Keywords: complicated skin and soft tissue infections (cSSTI) skin infection ceftaroline wound infection cellulitis burn infection bacterial infection vancomycin
Sponsor: Pfizer
Start date: 2014-06-01; Completion date: 2015-01-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effects of Ceftaroline Fosamil versus Vancomycin plus Aztreonam in treatment of patients with complicated bacterial skin and soft tissue infections.

Detailed description:
A Phase III, Multicentre, Randomised, Double-Blind Comparative Study to Evaluate the Efficacy and Safety of Ceftaroline Fosamil (600 mg every 8 hours) Versus Vancomycin Plus Aztreonam in the Treatment of Patients with Complicated Bacterial Skin and Soft Tissue Infections With Evidence of Systemic Inflammatory Response or Underlying Comorbidities

Arms: arm 1: Patients will receive 600 mg of ceftaroline fosamil administered as a 120-minute intravenous infusion very 8 hours. Each dose will be infused in a volume of 250 mL over 120-minutes followed by aztreonam placebo in a volume of 100 mL infused over 30 minutes every 8 hours. In addition vancomycin placebo will be given in a volume of 250 mL infused over 120 minutes every 12 hours. Doses will be adjusted according to the patient's renal function. arm 2: Patients will receive combination of vancomycin plus aztreonam. Dose of vancomycin will be based on the patient's actual weight and will receive intravenous vancomycin every 12 hours with each dose infused over 120-minutes. Aztreonam dose will be 1 gram intravenously in a volume of 100 mL infused over 30 minutes every 8 hours. In addition, ceftaroline fosamil placebo will be given in a volume of 250 mL infused over 120 minutes every 8 hours. Doses adjusted according to patients renal function
Interventions: intervention 1: Ceftaroline fosamil intervention 2: Vancomycin intervention 3: Aztreonam
Intervention descriptions: intervention 1: IV ceftaroline 600mg every 8 hours intervention 2: IV vancomycin 15mg/kg every 12 hours intervention 3: IV aztreonam 1 g every 8 hours

Protocol documents:
Clinical trial NCT02205476
Conditions: Hypertrophic Scars Resulting From Prior Breast Scar Revision Surgery
Keywords: Phase 2 open-label safety hypertrophic scar revision surgery
Sponsor: Pfizer
Start date: 2014-12-01; Completion date: 2015-01-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Study is a multicenter, two-part, open-label phase II study in adults, evaluating the safety and long-term efficacy of PF-06473871 one year after surgical revision and treatment with PF-06473871.

Detailed description:

Arms: arm 1: The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 1 = 4 doses). arm 2: The number of doses each subject receives will be consistent with number received in protocol B5301001 (Group 2 = 3 doses).
Interventions: intervention 1: PF-06473871 intervention 2: PF-06473871
Intervention descriptions: intervention 1: Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 4 administration of PF-06473871. intervention 2: Subjects who previously were randomized in B5301001 study will go under a second revision surgery followed by 3 administration of PF-06473871.

Protocol documents:
Clinical trial NCT02205814
Conditions: Knee Osteoarthritis
Keywords: Osteoarthritis, Knee Arthritis WOMAC Injections, intra-articular Fasitibant MEN 16132
Sponsor: Menarini Group
Start date: 2014-04-01; Completion date: 2015-01-01
Enrollment: 436 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed as a double-blind, randomised, placebo-controlled, four parallel arm, dose-finding study, to be conducted in approximately 26 sites, to evaluate the efficacy, safety, tolerability, and pharmacokinetics of single intra-articular (IA) injections of fasitibant in patients with symptomatic osteoarthritis (OA) of the knee.

Approximately 400 male and female patients 40-80 years old, with BMI \< 30 kg/m² and with a clinical diagnosis of symptomatic primary osteoarthritis of the knee will be randomised to a total of 4 treatment arms. Each arm includes a single intra-articular injection of one of three dosages of fasitibant (low, intermediate and high dose) OR placebo. The randomisation ratio will be 1:1:1:1.

The primary efficacy variable will be the change of the Western Ontario and McMaster Universities Visual Analogue Scale 3.1 A (WOMAC VA 3.1 A) (total pain) subscore from baseline up to 2 weeks after randomisation. Safety will be assessed by monitoring adverse events and clinical laboratory tests; local tolerability at the injection site will also be assessed. In addition, the population pharmacokinetics and the exposure-response relationship will be evaluated.

The individual experimental clinical phase will last up to maximal 15 weeks encompassing 7 planned visits at site, including screening, randomisation, 4 follow-up visits and the End of study visit.

Detailed description:

Arms: arm 1: Drug: solution for intra-articular injection arm 2: Drug: solution for intra-articular injection arm 3: Drug: solution for intra-articular injection arm 4: Drug: solution for intra-articular injection
Interventions: intervention 1: Fasitibant- low dose intervention 2: Fasitibant- intermediate dose intervention 3: Fasitibant- high dose intervention 4: Placebo comparator
Intervention descriptions: intervention 1: Single intra-articular injection of low dose of fasitibant intervention 2: Single intra-articular injection of intermediate dose of fasitibant intervention 3: Single intra-articular injection of high dose of fasitibant intervention 4: Single intra-articular injection of placebo

Protocol documents:
Clinical trial NCT02206607
Conditions: Type 2 Diabetes Mellitus
Keywords: Phase 1 bioavailability type 2 diabetes mellitus PF-04937319
Sponsor: Pfizer
Start date: 2014-09-01; Completion date: 2015-01-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Study B1621015 will characterize bioavailability, tolerability and pharmacodynamics of three modified release formulations of PF-04937319 compared with the immediate release material-sparing-tablet (IR MST) formulation in adults with type 2 diabetes.

Detailed description:

Arms: arm 1: Reference formulation arm 2: Test MR #1 arm 3: Test MR #2 arm 4: Test MR #3
Interventions: intervention 1: PF-04937319 IR MST intervention 2: PF-04937319 MR 1 intervention 3: PF-04937319 MR 2 intervention 4: PF-04937319 MR 3
Intervention descriptions: intervention 1: Immediate release material sparing tablet (IR MST) administered as 150 mg with morning meal and 100 mg with lunch intervention 2: Modified release formulation #1 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST intervention 3: Modified release formulation #2 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST intervention 4: Modified release formulation #3 administered with the morning meal at a dose predicted to yield exposure (AUC24) equivalent to 300 mg IR MST

Protocol documents:
Clinical trial NCT02224053
Conditions: Healthy Volunteer
Keywords: oncology, cancer, non small cell lung cancer, anticancer druge, omeprazole, healthy volunteer
Sponsor: AstraZeneca
Start date: 2014-09-01; Completion date: 2015-01-01
Enrollment: 136 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase 1, open-label, 2-period fixed sequence design to evaluate the interaction of AZD9291 with omeprazole in approximately 50 healthy, adult male volunteers. Volunteers will receive Treatment A (AZD9291 and omeprazole) in Period 1 and Treatment B (AZD9291 only) in Period 2. The dose of AZD9291 in Period 1 and the dose of AZD9291 in Period 2 will be separated by a washout of at least 21 days (the washout will not be more than 5 weeks). The study will be performed at up to 2 sites in the USA and will assess the effect of omeprazole (proton pump inhibitor) on AZD9291 exposure

Detailed description:

Arms: arm 1: Sequential treatments of AZD9291 + omeprazole followed by AZD9291 alone, with a washout period in between.
Interventions: intervention 1: Pharmacokinetic sampling - AZD9291 intervention 2: AZD9291 tablet dosing intervention 3: Omeprazole tablet dosing intervention 4: Pharmacokinetic sampling - AZ5140 and AZ7550
Intervention descriptions: intervention 1: Blood sampling to measure AZD9291 intervention 2: AZD9291 80mg tablet taken on Day 5 in Period 1 and Day 1 in Period 2. intervention 3: Omeprzole taken from Days 1 to 5 in Period 1. intervention 4: Blood samples to measure levels of AZ5140 and AZ7550

Protocol documents:
Clinical trial NCT02252445
Conditions: Catheter Site Discomfort Complications Anesthesia Urinary Bladder Neoplasms
Sponsor: Seoul National University Hospital
Start date: 2014-11-01; Completion date: 2015-01-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

Detailed description:
The mechanism of catheter-related bladder discomfort is thought to be related to the muscarinic receptor. Propofol and desflurane are most widely used as an anesthetic agent. Propofol and desflurane are known to block the muscarinic receptor in different ways.

The investigators want to evaluate the efficacy of the propofol and sevoflurane for the prevention of catheter-related bladder discomfort.

Arms: arm 1: Propofol will be administered as the anesthetic maintenance agent. arm 2: Sevoflurane will be administered as the anesthetic maintenance agent.
Interventions: intervention 1: Propofol intervention 2: Sevoflurane
Intervention descriptions: intervention 1: Propofol will be administered. intervention 2: Sevoflurane will be administered.

Protocol documents:
Clinical trial NCT02253160
Conditions: Healthy Apheresis Donors Mononuclear (MNC) Cell Donors
Keywords: MNCs Mononuclear Cells Apheresis Spectra Optia
Sponsor: Terumo BCT
Start date: 2014-09-01; Completion date: 2015-01-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this prospective, randomized, cross-over, multi-center study is to evaluate the performance of the Spectra Optia Apheresis System's CMNC Collection Procedure, compared to the COBE Spectra Apheresis System's MNC Procedure in mobilized healthy donors. Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the last collection.

Detailed description:
This is a prospective, randomized, cross-over, multi-center study to evaluate the performance of the Spectra Optia system's CMNC Collection Procedure, compared to the COBE Spectra system's MNC Procedure in mobilized healthy donors.

Up to 60 subject may be consented to meet the the enrollment target of 20 complete subjects. Eligible subjects will be randomized to receive either the Spectra Optia CMNC or the COBE Spectra MNC collection procedure first, followed by the opposite on the following day.

Study participation will be up to 14 days: a 7-day screening period, four days for mobilization, one day for the first MNC collection with additional dose of mobilization, one day for the second MNC collection, and safety follow-up the following day.

Subject safety will be evaluated beginning with mobilization, throughout the collection procedure and for the day following the second collection.

Arms: arm 1: Spectra Optia CMNC collection procedure followed by COBE Spectra MNC collection procedure. arm 2: COBE Spectra MNC collection procedure followed by Spectra Optia CMNC collection procedure.
Interventions: intervention 1: Spectra Optia CMNC intervention 2: COBE Spectra MNC intervention 3: Granulocyte-colony stimulating factor (G-CSF)
Intervention descriptions: intervention 1: The Spectra Optia® Apheresis System is an automated centrifugal system that separates whole blood into its cellular and plasma components. The device is comprised of three major sub-systems, 1) the apheresis machine itself (centrifuge, centrifuge filler, pumps, valves, computerized safety and control systems, etc.), 2) a sterile, single-use, disposable blood tubing set, and 3) embedded software. The Spectra Optia system's investigational CMNC procedure will be used to collect MNC from the peripheral blood. intervention 2: It is also a centrifugal system that separates whole blood into its cellular and plasma components. The COBE Spectra MNC collection procedure is chosen as the comparator device because it is the reference after which design of the Spectra Optia CMNC collection procedure was modeled. intervention 3: Each subject received an injection of the G-CSF approximately equivalent to 10 ug/kg body weight subcutaneous per day for 5 days prior to the MNC collection procedure.

Protocol documents:
Clinical trial NCT02280421
Conditions: Healthy
Keywords: HSV Herpes volunteers drug-drug interaction transplant
Sponsor: Maruho Europe Limited
Start date: 2014-10-01; Completion date: 2015-01-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
ASP2151 is an experimental treatment for herpes. Patients undergoing organ and tissue transplantation may be prescribed ciclosporin to suppress their immune system to give the transplant an increased chance of not being rejected. A patient with a compromised immune system is more susceptible to infections such as herpes, which will require treatment.

Detailed description:

Arms: arm 1: ASP2151 400mg + 100mg ciclosporin arm 2: ASP2151 1200mg + 100mg ciclosporin
Interventions: intervention 1: ASP2151 400mg + 100mg ciclosporin intervention 2: ASP2151 1200mg + 100mg ciclosporin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02300025
Conditions: Healthy Volunteer
Sponsor: Genentech, Inc.
Start date: 2014-08-01; Completion date: 2015-01-01
Enrollment: 28 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is an open-label, multi-center, single-dose, parallel group study to determine the pharmacokinetics, safety, and tolerability of cobimetinib administered at 10 mg to fasted male and female adult subjects with varying degrees of hepatic function. The study will be conducted based on the Child-Pugh classification of hepatic impairment. The anticipated duration of the study is 7.5 weeks. The target sample sizes are: 18 volunteers with varying degrees of hepatic function and up to 12 healthy control volunteers.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: cobimetinib
Intervention descriptions: intervention 1: single oral 10-mg dose of cobimetinib

Protocol documents:
Clinical trial NCT02313155
Conditions: Influenza Infection
Keywords: Prevention
Sponsor: Takeda
Start date: 2014-12-01; Completion date: 2015-01-01
Enrollment: 110 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and immunogenicity of a single subcutaneous injection of TAK-850 as compared to intramuscular injection of TAK-850 in healthy Japanese adults

Detailed description:
The drug being tested in this study is called TAK-850. This drug is being tested to evaluate the safety and immunogenicity of a single subcutaneous injection as compared to a single, intramuscular injection.

A total of 110 healthy participants (55 per group) will take part in this study.

Each participant will be randomly (like flipping a coin) assigned to receive one of the following :

* A single injection of TAK-850, subcutaneously , or
* A single injection of TAK-850, intramuscularly.

Participants will make up to 3 visits to the study site. Total duration of this study is 22 days.

Arms: arm 1: Single subcutaneous injection of TAK-850 arm 2: Single intramuscular injection of TAK-850
Interventions: intervention 1: Subcutaneous injection of TAK-850 intervention 2: Intramuscular injection of TAK-850
Intervention descriptions: intervention 1: TAK-850 0.5 mL, Subcutaneous injection intervention 2: TAK-850 0.5 mL, Intramuscular injection

Protocol documents:
Clinical trial NCT02327117
Conditions: Knee Arthroplasty, Total
Sponsor: Isfahan University of Medical Sciences
Start date: 2013-01-01; Completion date: 2015-01-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Total Knee Arthroplasty (TKA) is a common orthopedic surgery usually leads to Bleeding. The null hypothesis of this study was that TA has no effect on post surgical bleeding in patients undergoes TKA.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tranexamic Acid intervention 2: Normal saline
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02347605
Conditions: Tobacco Use Disorder
Sponsor: University of Minnesota
Start date: 2013-09-01; Completion date: 2015-01-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if changing the timeframe (relative to cue presentation) at which the nicotine lozenge is given can attenuate the increase in symptoms of tobacco craving and withdrawal that occur when smokers are presented with smoking cues. In this cross-over study, all subjects attend three laboratory sessions at which either nicotine lozenge or placebo is given prior to presentation of smoking cues or after presentation of smoking cues. The order in which the three conditions will be presented are randomized.

Detailed description:

Arms: arm 1: Nicotine lozenge is used 15 minutes prior to smoking cue exposure arm 2: Placebo lozenge is used 15 minutes prior to smoking cue exposure arm 3: Lozenge is used immediately after smoking cue exposure
Interventions: intervention 1: Nicotine lozenge 4 mg intervention 2: Placebo lozenge
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02370121
Conditions: Metabolic Syndrome
Keywords: Gymnema Sylvestre Insulin Secretion Insulin Sensitivity Central Obesity
Sponsor: University of Guadalajara
Start date: 2013-02-01; Completion date: 2015-01-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Gymnema sylvestre has demonstrated promising effects in the treatment of obesity, dyslipidemia, hypertension, insulin secretion, among others. The above mentioned findings show that Gymnema sylvestre has an excellent potential for the prevention and treatment of metabolic syndrome.

Detailed description:
A randomized, double-blind, placebo-controlled clinical trial was carried out in 24 patients with a diagnosis of metabolic syndrome in accordance with the modify International Diabetes Federation criteria. The patients received 300 mg capsules of Gymnema sylvestre or placebo, two times daily before breakfast and dinner for 90 days. Before and after intervention the investigators evaluated: The components of metabolic syndrome (waist circumference, triglycerides, high-density lipoprotein, fasting glucose and blood pressure), body weight, body mass index, total cholesterol, low-density lipoprotein, very-low-density lipoprotein, creatinine, aspartate transaminase and alanine transaminase.

Were calculated: Areas under the curve of glucose and insulin were calculated with de Trapezoidal formula. Total insulin secretion was evaluated with the Insulinogenic index and the insulin sensitivity was estimated using the Matsuda index.

Arms: arm 1: 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days. arm 2: 600 mg dose per day. Two capsules of 300 mg, one in the morning with the first meal and the other at dinner during 90 days.
Interventions: intervention 1: Placebo intervention 2: Gymnema Sylvestre
Intervention descriptions: intervention 1: Capsules of 300 mg two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days. intervention 2: Capsules of 300 mg of calcined magnesium two times per day before breakfast and dinner a total dose of 600 mg per day. During 90 days.

Protocol documents:
Clinical trial NCT02434523
Conditions: Laryngeal Diseases Chronic Laryngeal Neuropathy
Keywords: laryngeal sensory neuropathy
Sponsor: Boston Medical Center
Start date: 2013-09-01; Completion date: 2015-01-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis.

Detailed description:
The study will compare the effectiveness of amitriptyline versus placebo (inactive medication) in treating chronic laryngitis. At the baseline visit, subjects will be assigned at random to amitriptyline or placebo which they will take for 8 weeks. Subjects will be seen in the clinic at baseline and at 8 weeks. Improvement will be measured using standardized symptom scales, and a self-reported subjective improvement percentage.

Arms: arm 1: Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler) arm 2: Subjects in this arm will receive pills composed only of Avicel (cellulose filler)
Interventions: intervention 1: Amitriptyline intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects in this arm will receive pills composed of amitryptline and Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks intervention 2: Subjects in this arm will receive pills composed of only Avicel (cellulose filler), starting at 12.5mg nightly, and allowed to increase daily dose by 12.5mg with each subsequent week after enrollment if symptoms not resolved and no adverse effect noted at prior dose, up to maximum dose of 50mg nightly. Treatment duration is 8 weeks

Protocol documents: