ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01123889
Conditions: Subacromial Impingement Syndrome Partial Thickness Rotator Cuff Tear
Keywords: subacromial impingement partial thickness rotator cuff PRP platelet rich plasma
Sponsor: Loma Linda University
Start date: 2010-05-01; Completion date: 2011-05-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this investigator initiated study is to clinically evaluate the efficacy of a new treatment for subacromial impingement syndrome and partial thickness rotator cuff tears. This treatment consists of a platelet rich plasma injection into and around the rotator cuff. It is thought that this treatment will dramatically improve outcomes for patients suffering from these two conditions.

Subjects will be randomized by choosing a slip of paper from an envelope. This process will randomize 25 patients to the experimental group, and 25 patients to the control. The experimental group will undergo a blood draw, allowing for an injection of platelet rich plasma around the rotator cuff. The control group will undergo a corticosteroid injection into the subacromial space surrounding the rotator cuff as sole treatment. Patients will be followed for three months for pain, and will fill out questionnaires at six weeks and three months post injection, which will give insight into functionality and pain changes that the rotator cuff is experiencing due to treatment.

Subjects will be outpatients. Subjects may include employees, students, minorities, and elderly, although no subsets of these will be formed.

Subjects will be between 18 and 89 years of age.

In total, subject participation will last approximately 3 months.

Detailed description:

Arms: arm 1: corticosteroid injection into subacromial space arm 2: patients will receive an injection of platelet rich plasma into the subacromial space
Interventions: intervention 1: platelet rich plasma injection intervention 2: corticosteroid injection
Intervention descriptions: intervention 1: 45 ml of a patient's own blood will be collected via blood draw, maintaining sterile technique. This will then be spun down using a Magellan Autologous Platelet Separator System, yielding platelet rich plasma (PRP). Under sterile conditions, patients will receive a 5 cc PRP injection (consisting of their own PRP) with 1 cc of 1% lidocaine and 1 cc of 0.5% ropivacaine into the subacromial space, administered by an orthopedic surgeon. This will be done using a posterior lateral approach. The patient will be monitored for 10 minutes in clinic for adverse reactions. intervention 2: Under sterile conditions, patients will receive a 5cc injection consisting of 2cc 1% lidocaine, 2cc 0.5% ropivacaine, and 1cc kenalog corticosteroid (40mg/cc) into the subacromial space utilizing a posterior lateral approach. Patients will be observed for 10 min in clinic for any adverse reactions.

Protocol documents:
Clinical trial NCT01127646
Conditions: Attention Deficit Hyperactivity Disorder
Sponsor: Eli Lilly and Company
Start date: 2010-06-01; Completion date: 2011-05-01
Enrollment: 23 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The main purpose of the study is to help to understand the effect on children and adolescents who are stable on treatment with atomoxetine or osmotic-release oral system (OROS) methylphenidate for attention-deficit/hyperactivity disorder (ADHD) of not taking the medication for a maximum of 6 days over a 28-day study treatment period.

Detailed description:
The present study is designed to assess the effect of missed doses of daily medication (off-days). On the off-days the patient will take a placebo (sugar pill). Over the 4 weeks of the actual study there will be 6 random off-days of study medicine and neither the caregiver, patient nor study doctor will know which days are the missing days.

To cover all aspects of the patients' lives and notably their school time, aside from investigator's assessments, evaluations will also be performed on a daily basis by those involved in their day-to-day life: parents, teachers (on school days) and the patients themselves, using an electronic diary.

Arms: arm 1: Participants received 25-80 milligrams (mg) of atomoxetine orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 25-80 mg of atomoxetine orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 25-80 mg of atomoxetine orally, once daily for 1-5 days. arm 2: Participants received 18-54 mg of osmotic-release oral system (OROS) methylphenidate orally, once daily during the run-in period for up to 7 days. The run-in period was followed by the 4-week on/off period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 4 weeks, except for the off-days, where participants received 1 or 2 oral once daily placebo doses per week, with 6 nonconsecutive, double-blinded placebo doses in total over the 4-week on/off period. The on/off period was followed by a run-out period in which participants received 18-54 mg of OROS methylphenidate orally, once daily for 1-5 days.
Interventions: intervention 1: Atomoxetine intervention 2: Osmotic-release oral system methylphenidate intervention 3: Placebo
Intervention descriptions: intervention 1: 25-80 milligrams (mg) administered orally, once daily. intervention 2: 18-54 mg administered orally, once daily. intervention 3: Administered orally, once daily for random nonconsecutive 6 days during 4-week treatment period.

Protocol documents:
Clinical trial NCT01128595
Conditions: Asthma
Keywords: allergen challenge early asthmatic response mild asthma late asthmatic response
Sponsor: GlaxoSmithKline
Start date: 2010-05-01; Completion date: 2011-05-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
We propose to use an inhaled allergen challenge model to explore the individual contributions of the components of a novel long-acting beta agonist/ inhaled corticosteroid combination product and its components on protection from allergic triggers in asthma

Detailed description:
Asthma is an increasingly common disease and is essentially caused by an allergic type of reaction of the immune system. Airways of the lungs become inflamed and narrow as a result of a reaction to triggers like chemicals (house-hold cleaning products, pollution) and allergens (house dust mite and cat or dog fur). The airways become blocked, causing shortness of breath and wheezing. The purpose of this study is to find out more information about how effective the study drugs are at protecting the lungs against allergic triggers of asthma. There are three study drugs being investigated in this study: fluticasone furoate on its own, GW642444M on its own and a combination of fluticasone furoate (FF) and GW642444M.

FF is a corticosteroid that is being developed by for the treatment of asthma. A nasal spray formulation of FF has been approved for marketing in the USA, Europe and Japan for the treatment of hayfever (rhinitis) but the dry powder formulation used in this study is not yet approved.

GW642444M is a long-acting beta2-agonist being developed by GSK for the treatment of chronic obstructive pulmonary disease (COPD). It works by acting on cells in the lungs, causing some of the muscles around the lungs to relax and open up better (bronchodilation), making breathing easier. The combination of FF/GW642444M is being developed as a once-daily treatment for both asthma and COPD.

Study treatment will be taken for 21 days in each period (4 treatment periods: FF alone, GW642444M alone, FF/GW64244M combination and placebo) and each subject will receive all treatments. On D21 subjects will undergo an allergen challenge, followed by a methacholine challenge on D22. The washout between treatment periods will be 21-35 days.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: FF/GW642444M intervention 2: GW642444M intervention 3: Fluticasone Furoate intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01134393
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2010-05-01; Completion date: 2011-05-01
Enrollment: 502 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The general aim of this trial to determine the efficacy as measured by the percentage of patients reaching blood pressure goal at the end of the treatment period at 12 weeks. In-clinic blood pressures, home blood pressures and safety will be carefully monitored.

Detailed description:
Study Design:

Arms: arm 1: start low dose and uptitrate to high dose on the basis of blood pressure goal
Interventions: intervention 1: telmisartan/amlodipine
Intervention descriptions: intervention 1: start low dose and uptitrate to high dose on the basis of BP goal

Protocol documents:
Clinical trial NCT01140295
Conditions: Colonoscopy Preparation
Keywords: Preparation Pediatric Colonoscopy
Sponsor: Children's Hospital of Philadelphia
Start date: 2010-09-01; Completion date: 2011-05-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine whether Miralax results in a more efficacious preparation as compared to senna for pediatric colonoscopy.

Detailed description:
Study subjects will be randomized in two groups: Group one will receive 1.5 g/kg of Miralax orally the day before procedure and one day of clear liquid diet, while subjects in Group 2 will receive two doses of senna the day before procedure with two days of liquid diet (one day full liquid and one day clear liquid diet). On the day of the procedure parents/subjects will complete a questionnaire regarding prep compliance and adverse events. Electrolytes will be obtained prior to colonoscopy to monitor for electrolyte imbalance. Endoscopists will assess preparation for colonoscopy using validated cleanliness scale (Aronchick scale).

Arms: arm 1: Miralax colonoscopy preparation arm 2: Senna colonoscopy preparation
Interventions: intervention 1: polyethylene glycol, senna
Intervention descriptions: intervention 1: Senna dosage: Age 6-12 years: 3 teaspoons or 3 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. Age \>12 years: 6 teaspoons or 6 tablets by mouth 2 nights before endoscopy and 1 night before endoscopy. A Fleet's rectal enema is administered on the morning of the procedure.

Miralax at a dose of 1.5 grams/kg divided twice a day for two days; maximum of 51 grams per dose. Dissolve each 17 grams (1 capful) PEG-P in 240 mL water or other beverage according to the manufacturer's direction and to give the appropriate amount of PEG solution twice a day for two days.

Protocol documents:
Clinical trial NCT01143077
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: Lurasidone Schizophrenia Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2010-06-01; Completion date: 2011-05-01
Enrollment: 244 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lurasidone (lurasidone HCl) is a novel psychotropic agent that is being developed as a potential new antipsychotic treatment for patients with schizophrenia. Switching between antipsychotic medications is common in the treatment of schizophrenia. The current study is designed to evaluate the effectiveness, safety, and tolerability of switching clinically stable, but symptomatic outpatients with schizophrenia or schizoaffective disorder from their preswitch antipsychotic medication to lurasidone, over a period of 6 weeks.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Lurasidone HCl
Intervention descriptions: intervention 1: Lurasidone tablets, 40 mg/daily, 80 mg/daily, 120 mg/daily for 6 weeks

Protocol documents:
Clinical trial NCT01191476
Conditions: Elective Laparoscopic Surgery
Keywords: Sevoflurane Propofol Economics Pharmaceutical Chinese
Sponsor: Abbott
Start date: 2010-11-01; Completion date: 2011-05-01
Enrollment: 336 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being performed to compare the cost of anesthetic techniques with sevoflurane (low fresh gas flow balanced anesthesia) versus propofol (target controlled infusion \[TCI\]) versus propofol induction and sevoflurane maintenance anesthesia in subjects undergoing elective laparoscopic surgery with predicted anesthesic use between 1 and 3 hour duration.

Detailed description:
Three hundred thirty-six subjects were enrolled in this study. Two subjects, one treated with propofol for induction and maintenance and one treated with propofol for induction and sevoflurane for maintenance are not included in the study participation since no information was available for these two subjects.

Arms: arm 1: Subjects received sevoflurane, a inhalational (volatile) anesthetic, which was administered for induction and maintenance of general anesthesia. Inhalational induction was induced via vital capacity induction at 8% and maintained at 0.8-1.5 minimum alveolar concentration (MAC). arm 2: Subjects received propofol, an intravenous (IV) anesthetic, which was administered for induction and maintenance of general anesthesia. arm 3: Subjects received a bolus dose of propofol of 1.5 mg/kg administered for IV induction followed by sevoflurane at 0.8-1.5 MAC for maintenance anesthesia.
Interventions: intervention 1: Sevoflurane Inhalational Induction and Maintenance intervention 2: Propofol Target Controlled Infusion for Induction and Maintenance intervention 3: Propofol Target Controlled Infusion for Induction and Sevoflurane Inhalation for Maintenance
Intervention descriptions: intervention 1: Sevoflurane was administered at a concentration of 8% via vital capacity induction and sevoflurane 0.8-1.5 minimum alveolar concentration (MAC) with a rate of 1 L/min fresh gas flow for maintenance. intervention 2: Propofol IV 4 ug/mL was administered with target controlled infusion (TCI) for induction and propofol 3 to 6 ug/mL was administered with TCI for maintenance. intervention 3: Propofol was administered as a bolus IV dose of 1.5 mg/kg for induction at a rate of 40 mg/10 seconds. During maintenance, a sevoflurane concentration of 0.8-1.5 minimal alveolar concentration (MAC) was administered at a rate of 1 L/min fresh gas flow.

Protocol documents:
Clinical trial NCT01193049
Conditions: Asthma
Keywords: Nasal Allergen Challenge, Inhaled Allergen Challenge, Asthma
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-08-01; Completion date: 2011-05-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the relationship between upper and lower airway allergen-induced cytokine responses in mild asthmatics by attempting to demonstrate the following: 1) a positive correlation between allergen-induced Type 2 T-helper cell (Th2) cytokines (interleukins 5 and 13) in sputum and nasal exudates; and 2) a positive correlation between effects of prednisone versus placebo on Th2 cytokines in sputum and nasal exudates.

Detailed description:

Arms: arm 1: Prednisone in the first crossover treatment period and placebo in the second crossover treatment period arm 2: Placebo in the first crossover treatment period and prednisone in the second crossover treatment period
Interventions: intervention 1: Prednisone intervention 2: Placebo
Intervention descriptions: intervention 1: Prednisone (25 mg) tablets as a single oral dose on Day 1 of each study period intervention 2: Matching placebo tablets as a single oral dose on Day 1 of each study period

Protocol documents:
Clinical trial NCT01199861
Conditions: Relapsing Multiple Sclerosis
Keywords: Relapsing multiple sclerosis MS Immune response
Sponsor: Novartis
Start date: 2010-08-01; Completion date: 2011-05-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effect of treatment with fingolimod on the immune response following seasonal influenza vaccination and tetanus booster injection in patients with relapsing MS.

Detailed description:

Arms: arm 1: Participants received Fingolimod 0.5 mg capsules orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination. arm 2: Participants received placebo tablets orally once daily for 12 weeks. At Week 6 of study treatment participants received a seasonal influenza vaccination and a tetanus booster vaccination.
Interventions: intervention 1: Fingolimod intervention 2: Placebo intervention 3: Seasonal influenza vaccine intervention 4: Tetanus toxoid vaccine
Intervention descriptions: intervention 1: Fingolimod 0.5 mg capsules for oral administration. intervention 2: Matching placebo capsules for oral administration. intervention 3: Commercially available injectable influenza vaccine for the 2010/11 influenza season. intervention 4: Commercially available tetanus toxoid vaccine booster injection.

Protocol documents:
Clinical trial NCT01201057
Conditions: Bacterial Vaginosis
Keywords: SPL7013 VivaGel bacterial vaginosis BV
Sponsor: Starpharma Pty Ltd
Start date: 2010-08-01; Completion date: 2011-05-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of SPL7013 Gel in the treatment of bacterial vaginosis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: 0.5% SPL7013 Gel intervention 2: 1.0% SPL7013 Gel intervention 3: 3.0% SPL7013 Gel intervention 4: Placebo Gel
Intervention descriptions: intervention 1: Vaginal gel intervention 2: Vaginal gel intervention 3: Vaginal gel intervention 4: Vaginal gel

Protocol documents:
Clinical trial NCT01227421
Conditions: Influenza
Keywords: influenza
Sponsor: Romark Laboratories L.C.
Start date: 2010-12-01; Completion date: 2011-05-01
Enrollment: 624 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized clinical trial designed to evaluate the safety/efficacy of two dosing regimens of oral nitazoxanide compared to placebo in the treatment of acute uncomplicated influenza in adults and adolescents. The investigators hypothesize that treatment with Nitazoxanide will reduce the duration of symptoms in patients with confirmed influenza infection. Secondarily, the investigators hypothesize that treatment with nitazoxanide will reduce the complications of influenza, severity of symptoms, time lost from work, time to return to normal daily activities.

Detailed description:
A Randomized, Double-Blind, Placebo Controlled Study of Nitazoxanide in Adults and Adolescents with Acute Uncomplicated Influenza. The primary objectives of this study are to demonstrate the efficacy of nitazoxanide administered 300 mg two times per day for 5 days or 600 mg two times per day for 5 days in reducing the time to resolution of all clinical symptoms of influenza.

The study will also evaluate pharmacokinetics of nitazoxanide in a subset of 24 patients and the safety of the nitazoxanide regimen compared to a placebo via analysis of adverse events and laboratory safety tests.

Blood samples will be collected for all patients at baseline, day 7 and day 28, and for a subset of 24 patients aged 18-65 years (pharmacokinetics subset) on day 2. Urine samples will be collected at baseline and day 7. Nasal swabs will be collected at baseline and day 7 for all patients and on days 2, 3, 4 and 5 for a subset of patients (approximately 20% of patients).

Arms: arm 1: 300 mg nitazoxanide tablet and 1 placebo tablet twice daily for 5 days arm 2: Two 300 mg nitazoxanide tablets(600mg) twice daily for 5 days arm 3: 2 placebo tablets twice daily for 5 days
Interventions: intervention 1: Nitazoxanide intervention 2: Nitazoxanide intervention 3: Placebo
Intervention descriptions: intervention 1: Tablets, 300 mg (one 300 mg tablet + 1 placebo tablet) with food twice daily for 5 days intervention 2: Tablets, 600 mg (two 300 mg tablets) with food twice daily for 5 days intervention 3: Tablets, (2 tablets) twice daily with food for 5 days

Protocol documents:
Clinical trial NCT01228071
Conditions: Male Hypogonadism
Keywords: testosterone deficiency hypogonadism
Sponsor: Endo Pharmaceuticals
Start date: 2010-11-01; Completion date: 2011-05-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a multicenter, open-label, single arm trial to evaluate the time to eugonadal testosterone range after initial testosterone gel 2% application, time to steady state after after initiation of testosterone gel 2%, and drying time after application of testosterone gel 2%.

Detailed description:
Assessment of Time to Eugonadal Testosterone Range After Initial Fortesta (Testosterone) Gel 2% Application, Time to Steady State After Initiation of Fortesta, And Gel Drying Time After Fortesta Application

Arms: arm 1: testosterone gel 2%
Interventions: intervention 1: testosterone gel 2%
Intervention descriptions: intervention 1: 40 mg testosterone gel 2%

Protocol documents:
Clinical trial NCT01235936
Conditions: Anemia Kidney Disease
Keywords: anemia chronic kidney disease CKD chronic renal insufficiency renal impairment erythropoietin safety efficacy tolerability pharmacokinetics
Sponsor: Akebia Therapeutics
Start date: 2010-10-21; Completion date: 2011-05-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the safety, pharmacodynamics and pharmacokinetics of repeat doses of orally administered AKB-6548 in pre-dialysis participants with anemia.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: AKB-6548
Intervention descriptions: intervention 1: Different dose levels

Protocol documents:
Clinical trial NCT01241539
Conditions: Cardiovascular Diseases Kidney Failure, Chronic
Sponsor: Boehringer Ingelheim
Start date: 2010-11-01; Completion date: 2011-05-01
Enrollment: 7 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The current study will allow the assessment of pharmacokinetics, pharmacodynamics, elimination rate and clearance of dabigatran etexilate during and following haemodialysis in ESRD patients.

Detailed description:

Arms: arm 1: Capsule, oral arm 2: Capsule, oral arm 3: Capsule, oral
Interventions: intervention 1: Dabigatran etexilate intervention 2: Dabigatran etexilate intervention 3: Dabigatran etexilate
Intervention descriptions: intervention 1: 150 mg capsule intervention 2: 75 mg capsule intervention 3: 110 mg capsule

Protocol documents: