ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01686646
Conditions: Common Cold
Keywords: alertness
Sponsor: GlaxoSmithKline
Start date: 2011-11-01; Completion date: 2012-11-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate any improvement in alertness and performance based on cognitive function and mood assessment in subjects suffering the common cold, when taking a novel paracetamol and caffeine combination verses paracetamol alone.

Detailed description:

Arms: arm 1: highest dose of Paracetamol and caffeine arm 2: lowest dose of Paracetamol and caffeine arm 3: highest dose paracetamol arm 4: lowest dose paracetamol
Interventions: intervention 1: paracetamol + caffeine intervention 2: paracetamol
Intervention descriptions: intervention 1: paracetamol with caffeine intervention 2: paracetamol

Protocol documents:
Clinical trial NCT01691560
Conditions: Dentine Hypersensitivity
Sponsor: GlaxoSmithKline
Start date: 2012-08-01; Completion date: 2012-11-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this exploratory study is to compare the treatment effect on dentinal hypersensitivity of a tubule occluding dentifrice as measured by Schiff and Tactile sensitivity. This proof of concept study will compare the test dentifrice with three other treatment groups.

Detailed description:
This will be a single center, eight week, randomized, controlled, examiner blind, four treatment arm, parallel design, stratified (by maximum baseline Schiff Sensitivity Score of the two selected test teeth), exploratory study in participants with at least two sensitive teeth that meet all the criteria at the Screening and Baseline visit. Participants will be assessed at Baseline, four and eight weeks to monitor clinical efficacy and safety.

Arms: arm 1: Dentifrice containing 5.0% w/w calcium sodium phosphosilicate with sodium monofluorophosphate containing 1500 parts per million fluoride (ppmF). arm 2: Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate arm 3: Dentifrice containing 1000 ppmF as sodium monofluorophosphate arm 4: Dentifrice containing 1100 ppmF as sodium fluoride
Interventions: intervention 1: 5% calcium sodium phosphosilicate/ sodium monofluorophosphate dentifrice intervention 2: 0% calcium sodium phosphosilicate/sodium monofluorophosphate dentifrice intervention 3: Sodium monofluorophosphate dentifrice intervention 4: Sodium fluoride dentifrice
Intervention descriptions: intervention 1: Dentifrice containing 5.0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate intervention 2: Dentifrice containing 0% w/w calcium sodium phosphosilicate and 1500ppmF as sodium monofluorophosphate intervention 3: Dentifrice containing 1000 ppmF as sodium monofluorophosphate intervention 4: Dentifrice containing 1100 ppmF as sodium fluoride

Protocol documents:
Clinical trial NCT01709422
Conditions: Disorders of Gallbladder, Biliary Tract and Pancrease
Keywords: Propofol Midazolam Meperidine
Sponsor: Prince of Songkla University
Start date: 2010-06-01; Completion date: 2012-11-01
Enrollment: 140 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare efficacy and safety of combination of propofol and midazolam with meperidine versus midazolam and meperidine for ambulatory ERCP

Detailed description:
ERCP is commonly done under sedation with midazolam and meperidine, however some studies showed varying outcomes of this conventional sedation for maintained sedation. Propofol is increasing used for sedation in gastrointestinal procedure owing to its rapid recovery profiles but the complications associated with propofol are not negligible.The investigators prospectively compare the efficacy, induction time, recovery time, patient satisfaction and side effect between propofol based and conventional sedations in patients undergoing ERCP.

Arms: arm 1: both midazolam (1mg if aged \<= 70 years or 0.5mg in age \>70 years) and meperidine 20 mg were given intravenously at the initiation of sedation, Thereafter, an initial bolus of propofol 20 mg intravenously. Sedation was maintained with repeated dose of 5 to 10 mg propofol. arm 2: both midazolam 2 to 5 mg and meperidine 25 to 50 mg were given intravenously at the initiation of sedation. Sedation was maintained with repeated doses of 0.5 to 1.0 mg midazolam and 5 to 10 mg meperidine.
Interventions: intervention 1: Propofol intervention 2: Midazolam intervention 3: Meperidine
Intervention descriptions: intervention 1: Propofol is the sedative drug used as an additional sedation to one of the study arm. intervention 2: Midazolam is one of the two conventional sedative drugs included in both arms. intervention 3: Meperidine is one of the two conventional sedative drugs included in both arms.

Protocol documents:
Clinical trial NCT01710007
Conditions: Hypercholesterolemia
Keywords: HMG-CoA reductase inhibitors
Sponsor: Orient Pharma Co., Ltd.
Start date: 2011-11-01; Completion date: 2012-11-01
Enrollment: 202 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
1PC002 is a newly developed synthetic and highly potent HMG-CoA reductase inhibitor. Its active compound, pitavastatin has recently been approved by US FDA for indications of primary hypercholesterolemia and combined dyslipidaemia. It exhibits unique pharmacokinetic properties. Unlike atorvastatin which is metabolized by CYP3A4, metabolism of 1PC002 does not depend on CYP3A4. This multi-center study is conducted to confirm the efficacy and safety of 1PC002 administered for 12 weeks is non-inferior to atorvastatin.

Detailed description:
This is a prospective, active-controlled, double-blind, randomized, parallel, and multi-center study. To target 150 evaluable subjects, approximately 200 Taiwanese patients with primary hypercholesterolemia or combined dyslipidemia will be enrolled in this study.

After providing the written inform consent, patients will undergo a complete physical examination, vital sign (brachial BP / HR), medical history, and lab assessment, including fasting serum LDL-C, TC, HDL-C, TG, and non-HDL. They should not take any hypolipidemic drugs for at least 4 weeks prior to initiation of study treatment. All eligible subjects will be randomized into 2 groups in a 1:1 ratio to receive either 2 mg 1PC002 or 10 mg atorvastatin once daily for 12 weeks.

* Study Group: 1PC002 1 cap. q.d. p.o.
* Control Group: Atorvastatin 1 cap. q.d. p.o.

After entering the baseline visit, lipid profiles (including fasting serum LDL-C, TC, HDL-C, TG, non-HDL, Apo A1, Apo B and Apo B / Apo A1 ratio), hs-CRP, eGFR, spot urinary albumin / creatinine ratio (ACR) and central BP values will be obtained at baseline, Week 4 and Week 12 for evaluating the effectiveness of study drugs and for any possible changes in laboratory data. Non-HDL value will be calculated by subtracting HDL-C from TC. Moreover, serum Cystatin C, another biomarker of renal function, will also be assessed at baseline and Week 12.

For monitoring the safety, biochemical and hematological assessment will be performed at baseline, Week 4 and 12. Additional liver function and CK test will be conducted at Week 8. The occurring AE(s) and SAE will be followed until resolution or the event is considered stable.

Arms: arm 1: 2 mg 1PC002 once daily for 12 weeks. arm 2: 10 mg atorvastatin once daily for 12 weeks.
Interventions: intervention 1: 1PC002 intervention 2: Lipitor
Intervention descriptions: intervention 1: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended. intervention 2: Subjects should be instructed to take 1 capsule of study drug (1PC002 or atorvastatin) orally once a day, with or without food. Administration before bedtime or at regular time-interval is recommended.

Protocol documents:
Clinical trial NCT01737931
Conditions: Healthy
Keywords: SPM 962 rotigotine application site reaction
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2012-08-01; Completion date: 2012-11-01
Enrollment: 120 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To investigate the efficacy of symptomatic therapy with topical steroids and antihistamines for application site reaction (ASR) after administration of SPM 962 in healthy subjects

Detailed description:

Arms: arm 1: Topical medication of steroid (Dexamethasone) to the application sites after the patch removal arm 2: Topical medication of antihistamine(Diphenhydramine) to the application sites after the patch removal arm 3: No treatment to the application sites after the patch removal
Interventions: intervention 1: Topical steroid (Dexamethasone) intervention 2: Topical antihistamine (Diphenhydramine)
Intervention descriptions: intervention 1: for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for steroid: twice daily administration of Dexamethasone (1 mg/g cream) to the application sites after the patch removal intervention 2: for SPM 962: 1 mg/24h patch for 48 hours as Acceleration period, then 2 mg/24h patch to the other site for 24 hours as Dose-escalation period, for antihistamine: twice daily administration of Diphenhydramine (10 mg/g cream) to the application sites after the patch removal

Protocol documents:
Clinical trial NCT01755026
Conditions: Cesarean Delivery Wound Infection Obesity
Keywords: Cesarean Delivery Wound infection Obesity Prophylactic antibiotics
Sponsor: Michael Stitely
Start date: 2010-11-01; Completion date: 2012-11-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients undergoing Cesarean delivery (C-Section) with a body mass index of 35 or greater (this BMI number is in the obese range) will be given either 2 grams or 4 grams of an antibiotic before surgery. The antibiotic is intended to prevent infection from the surgery.It is unknown what the best dose for large women is for the usual medicine used for this purpose (an antibiotic medicine called cefazolin).Samples of the tissue just under the skin will be biopsied at the time the incision is made and at the time the cut is stitched or stapled closed. A sample of the muscle of the womb will be taken as the womb is stitched closed after the delivery. Blood tests will be done at the start and end of surgery to test the antibiotic level. A blood sample will be taken from the umbilical cord after the baby has been delivered and the umbilical cord has been cut. The umbilical cord blood sample will be tested for the antibiotic level.These tests will be used to find out if the usual dose of medicine is enough or if more medicine is needed to prevent infection in large women undergoing c-sections.

Detailed description:

Arms: arm 1: 2 gram dose of pre-operative cefazolin arm 2: 4 gram dose of pre-operative prophylaxis
Interventions: intervention 1: cefazolin intervention 2: cefazolin
Intervention descriptions: intervention 1: 2 gram dose for pre-operative prophylaxis intervention 2: 4 gram dose for pre-operative prophylaxis

Protocol documents:
Clinical trial NCT01755455
Conditions: Cystic Fibrosis Anemia, Iron-Deficiency
Keywords: Cystic fibrosis Iron Hepcidin Anemia Erythropoiesis
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2011-06-01; Completion date: 2012-11-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study questions whether low-dose ferrous sulfate taken by mouth daily for 6 weeks increases hemoglobin concentration in adult subjects with cystic fibrosis and hypoferremic anemia.

Detailed description:

Arms: arm 1: Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks arm 2: Identical-appearing tablet taken by mouth daily for 6 weeks
Interventions: intervention 1: Ferrous sulfate 325mg intervention 2: Placebo
Intervention descriptions: intervention 1: Ferrous sulfate 325mg tablet taken by mouth daily for 6 weeks intervention 2: Matching placebo capsule

Protocol documents:
Clinical trial NCT01931527
Conditions: Obesity Metabolic Syndrome Hyperuricemia
Keywords: Obesity Metabolic syndrome Hyperuricemia
Sponsor: Washington University School of Medicine
Start date: 2006-07-01; Completion date: 2012-11-01
Enrollment: 31 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn more about what is the effect of uric acid on oxidative stress and on the way the body metabolizes sugar in obese people. Understanding this may lead to better diseases such as diabetes.

Detailed description:
It has been hypothesized that oxidative stress is involved in the pathogenesis of insulin resistance associated with obesity. Circulating uric acid (UA) is the body's major endogenous plasma antioxidant. Therefore, the investigators evaluated whether alterations in serum UA concentration affect: 1) systemic and skeletal muscle oxidative stress, 2) total antioxidant capacity, and 4) skeletal muscle insulin sensitivity during a hyperinsulinemic-euglycemic clamp.

Arms: arm 1: Subjects with a body mass index = or \> 30 kg/m² with normal uric acid (= or \< 5 mg/dL) arm 2: Subjects with a body mass index = or \> 30 kg/m² with high uric acid (\>6 mg/dL)

Intervention: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min
Interventions: intervention 1: Rasburicase
Intervention descriptions: intervention 1: one single infusion of rasburicase (0.19 mg/kg FFM) infused over 30 min

Protocol documents:
Clinical trial NCT02287402
Conditions: Impaired Glucose Tolerance (IGT)
Sponsor: Takeda
Start date: 2010-03-01; Completion date: 2012-11-01
Enrollment: 197 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of open-label study is to evaluate the efficacy and safety of AO-128 (Voglibose) 0.6 mg/day in patients with impaired glucose tolerance (IGT) who had been non-responsive to diet therapy and exercise therapy, and follow up the progress after the end of treatment in patients who was assessed as normoglycemic.

Detailed description:
The α-glucosidase inhibitor voglibose was developed by Takeda Pharmaceutical Co. Ltd and is one of the most commonly used oral antidiabetic agents in Japan. Voglibose is used as first-line treatment for improvement of postprandial hyperglycemia in diabetic patients with inadequate response to diet and exercise therapy and as add-on treatment to other oral antidiabetic drugs and insulin. In 2009, voglibose was approved in Japan for the management of prediabetes (IGT).

This study was a single-group, multi-center, open-label study. The study period consisted of a screening period of 1 week or less, a treatment period of 96 weeks or more, and a follow-up period of 48 weeks. However, if a patient was assessed as having type 2 diabetes mellitus or normoglycemia, the treatment period was to be ended, and only those assessed as normoglycemic were to proceed to follow-up. Follow-up was also to be terminated if patients were assessed as having IGT or type 2 diabetes mellitus during follow-up.

Arms: arm 1: One AO-128 0.2 mg tablet was taken orally 3 times a day before meals.
Interventions: intervention 1: AO-128
Intervention descriptions: intervention 1: AO-128 tablet

Protocol documents:
Clinical trial NCT01218113
Conditions: AIDS
Keywords: Human Immunodeficiency Virus (HIV)-1 safety vaccine immunogenicity reactogenicity HIV infection
Sponsor: GlaxoSmithKline
Start date: 2010-11-08; Completion date: 2012-11-05
Enrollment: 191 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to determine whether administration of the GSK Biologicals HIV vaccine 732462 can lead to a reduction in viral load, and impact on the course of human immunodeficiency virus type 1 (HIV-1) infection. In HIV-1 infected persons who have not yet started antiretroviral therapy (ART), such a vaccine would potentially lead to a delay in the initiation of treatment.

Detailed description:

Arms: arm 1: HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of the HIV Vaccine 732462 at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm. arm 2: HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 2 doses of the HIV Vaccine 732462 at Weeks 0 and 4 and one dose of placebo (saline solution) at Week 28, administered intramuscularly in the deltoid of the non-dominant arm. arm 3: HIV-1 infected male and female subjects, between and including 18 to 55 years of age at the time of first vaccination, who received 3 doses of placebo (saline solution) at Weeks 0, 4 and 28, administered intramuscularly in the deltoid of the non-dominant arm.
Interventions: intervention 1: GSK Biologicals HIV Vaccine 732462 intervention 2: Placebo
Intervention descriptions: intervention 1: 2 or 3 doses according to protocol schedule intervention 2: 1 or 3 doses according to protocol schedule

Protocol documents:
Clinical trial NCT01479764
Conditions: Surgical Procedures, Elective
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-12-02; Completion date: 2012-11-05
Enrollment: 154 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the incidence of residual neuromuscular blockade in participants who undergo reversal of neuromuscular blockade with sugammadex compared to those who undergo reversal of neuromuscular blockade with usual care (neostigmine/glycopyrrolate).

Detailed description:

Arms: arm 1: Participants receive sugammadex, 2 or 4 mg/kg, depending on level of neuromuscular recovery arm 2: Participants receive neostigmine/glycopyrrolate per usual practice
Interventions: intervention 1: Sugammadex intervention 2: Neostigmine intervention 3: Glycopyrrolate
Intervention descriptions: intervention 1: sugammadex, intravenous (IV) bolus, 2 or 4 mg/kg depending on level of neuromuscular recovery intervention 2: neostigmine, per usual practice intervention 3: glycopyrrolate per usual practice

Protocol documents:
Clinical trial NCT00998985
Conditions: Hepatitis C
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-02-23; Completion date: 2012-11-08
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This multiple dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of grazoprevir (MK-5172) in Genotype (GT) 1 and GT3 Hepatitis C virus (HCV)- infected participants. The primary hypothesis is that administration of grazoprevir for 7 days is sufficiently safe and well tolerated in HCV-infected males.

Detailed description:

Arms: arm 1: GT1 HCV-infected Participants: 400 mg Grazoprevir or Placebo arm 2: GT1 HCV-infected Participants: 600 mg Grazoprevir or Placebo arm 3: GT1 HCV-infected Participants: 800 mg Grazoprevir or Placebo arm 4: GT3 HCV-infected Participants: 400 mg Grazoprevir or Placebo arm 5: GT3 HCV-infected Participants: 600 mg Grazoprevir or Placebo arm 6: GT3 HCV-infected Participants: 800 mg Grazoprevir or Placebo arm 7: GT1 HCV-infected Participants: 200 mg Grazoprevir or Placebo arm 8: GT1 HCV-infected Participants: 100 mg Grazoprevir or Placebo arm 9: GT1 HCV-infected Participants: 50 mg Grazoprevir or Placebo arm 10: GT3 HCV-infected Participants: 200 mg Grazoprevir or Placebo arm 11: GT3 HCV-infected Participants: 100 mg Grazoprevir or Placebo arm 12: GT3 HCV-infected Participants: 50 mg Grazoprevir or Placebo arm 13: GT1 HCV-infected Participants: 30 mg Grazoprevir or Placebo arm 14: GT1 HCV-infected Participants: 10 mg Grazoprevir or Placebo
Interventions: intervention 1: Grazoprevir intervention 2: Placebo
Intervention descriptions: intervention 1: 10, 30, 50, 100, 200, 400, 600 or 800 mg Grazoprevir tablets, orally, once a day for 7 days intervention 2: Placebo tablet, orally, once a day for 7 days

Protocol documents:
Clinical trial NCT01085084
Conditions: Lupus Arthritis
Keywords: Systemic Lupus Erythematosus (SLE) Lupus Arthritis Laquinimod
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2010-10-04; Completion date: 2012-11-12
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study aims to evaluate the safety and clinical effect of daily oral treatment with laquinimod capsules (0.5 milligrams \[mg\] and 1 mg) in participants with active lupus arthritis. Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

Detailed description:

Arms: arm 1: Participants will receive 2 capsules of placebo matched to laquinimod orally once daily for 12 weeks. arm 2: Participants will receive 1 capsule of laquinimod 0.5 mg and 1 capsule of placebo matched to laquinimod orally once daily for 12 weeks. arm 3: Participants will receive 2 capsules of laquinimod 0.5 mg orally once daily for 12 weeks.
Interventions: intervention 1: Laquinimod intervention 2: Placebo
Intervention descriptions: intervention 1: Laquinimod will be administered per dose and schedule specified in the arm description. intervention 2: Placebo matching to laquinimod will be administered per schedule specified in the arm description.

Protocol documents:
Clinical trial NCT01220726
Conditions: Overactive Bladder
Keywords: OAB
Sponsor: Weill Medical College of Cornell University
Start date: 2009-06-01; Completion date: 2012-11-13
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective, randomized, double-blind study comparing intravesical injection of BOTOX to placebo. Study subjects will be randomized (1:1 ratio) to one of the following treatment groups:

Detailed description:
Group 1 n=20 BOTOX® 200U Group 2 n=20 Placebo BOTOX® (saline) At Visit 2 (Treatment, Day 0), subjects will receive one injection cycle of BOTOX (200U) or placebo (saline). The study duration is approximately 284 days and consists of a Screening Visit (Day -7 to -14), a Treatment/Randomization Visit (Visit 2, Day 0), and Follow-up Visits at 7, 30, 90, 180, and 270 Days. Telephone Follow-ups will be made 3 days following the injection cycle.

Subjects demonstrating an insufficient response to treatment may receive an open-label injection cycle of BOTOX (200U) at Day 90. Subjects receiving this injection will re-commence Follow-up Visits and be followed for an additional 270 days.

Arms: arm 1: 200U onabotulinumtoxinA (botox) arm 2: 200U Saline
Interventions: intervention 1: Botox intervention 2: Placebo
Intervention descriptions: intervention 1: Botox injection intervention 2: Placebo injection

Protocol documents: