ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01143272
Conditions: Antibiotic-associated Diarrhea Clostridium Difficile Diarrhea
Keywords: antibiotic associated diarrhoea saccharomyces boulardii Antibiotic-associated diarrhoea (AAD) Clostridium difficile-associated-diarrhoea (CDAD)
Sponsor: Bernhard Nocht Institute for Tropical Medicine
Start date: 2010-06-01; Completion date: 2012-10-01
Enrollment: 477 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
When patients in hospitals receive antibiotics they often develop diarrhoea. The consequences may be grave for the patient. Thus far, no preventive measure is available. The investigators hypothesize that the apathogenic yeast Saccharomyces boulardii, administered in addition to the antibiotic, may prevent episodes of diarrhoea or may lead to less pronounced diarrhoea. To test this hypothesis, the investigators are carrying out a clinical trial in 1520 adult patients in several hospitals.

Detailed description:
Antibiotic-associated diarrhoea (AAD) is a frequent condition in hospitalised patients receiving antibiotic treatment. The same is true for Clostridium difficile-associated diarrhoea (CDAD) with even more grave consequences of increased morbidity and mortality. The development and evaluation of preventive strategies is one key public health challenge. In the absence of clinically evaluated alternatives, probiotics have been suggested to be beneficial for the prevention of AAD and CDAD. However, data have so far been inconclusive and recently published meta-analyses strongly recommended large state-of-the-art clinical trials on probiotic substances for the prevention of AAD and CDAD. Since the efficacy, side-effects and modes of action of different probiotic bacteria and yeast are strain specific, benefits and risks cannot be generalised. The non-pathogenic yeast Saccharomyces cerevisiae var. boulardii (Sac. boulardii) is considered the most promising probiotic substance for the prevention of AAD and CDAD. We carry out a randomised, placebo controlled, double blind multicentre clinical trial to evaluate Sac. boulardii for the indication of prevention of AAD and CDAD in 1520 adult, hospitalised patients.

Arms: arm 1: Participants received Saccharomyces boulardii 250 mg capsules twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation arm 2: Participants received matching placebo twice per day within 24 hours of initiating antibiotic treatment and continued treatment for 7 days after antibiotic discontinuation
Interventions: intervention 1: Saccharomyces boulardii intervention 2: Placebo
Intervention descriptions: intervention 1: Units: 500 mg per day Route of administration : Oral Use Hard-Capsule intervention 2: Placebo

Protocol documents:
Clinical trial NCT01143714
Conditions: Diabetic Foot Ulcers
Sponsor: Healthpoint
Start date: 2010-06-01; Completion date: 2012-10-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the effect of four weeks of treatment with Santyl Ointment, compared to White Petrolatum, on the change from baseline in wound area of diabetic foot ulcers over four weeks, and on the proportion of subjects achieving complete wound closure within 12 weeks from initiation of treatment.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Santyl intervention 2: White Petrolatum
Intervention descriptions: intervention 1: Apply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks. intervention 2: Apply an amount sufficient (thickness of a nickel) to cover the wound area. It will be applied once daily during the treatment phase, up to four weeks.

Protocol documents:
Clinical trial NCT01143727
Conditions: Diabetic Foot Ulcers
Sponsor: Healthpoint
Start date: 2010-07-01; Completion date: 2012-10-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study compares two standard methods for cleaning the surface of wounds on the feet of patients with diabetes mellitus. The question being asked is whether inflammation of the wound affects the ability of one or both of the methods to work.

Detailed description:

Arms: arm 1: Santyl arm 2: Tegaderm Hydrogel
Interventions: intervention 1: Santyl intervention 2: Tegaderm Hydrogel
Intervention descriptions: intervention 1: Apply one 24-hr period sufficient to cover the wound. intervention 2: Apply once 24-hr period sufficient to cover the wound.

Protocol documents:
Clinical trial NCT01154036
Conditions: Hypercholesterolemia
Sponsor: Organon and Co
Start date: 2010-07-01; Completion date: 2012-10-01
Enrollment: 1547 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the lipid-altering efficacy and safety of switching to co-administration of ezetimibe and atorvastatin versus treatment with atorvastatin or rosuvastatin in high cardiovascular risk patients with hypercholesterolemia who have not achieved specified low-density lipoprotein cholesterol (LDL-C) levels. The primary hypothesis is that the co-administration of ezetimibe 10 mg and atorvastatin 10 mg will be superior to both atorvastatin 20 mg and rosuvastatin 10 mg with respect to the percentage reduction in low-density lipoprotein-cholesterol (LDL-C) after 6 weeks of treatment.

Detailed description:
This is a 18 week randomized, double-blind, active-controlled, multicenter study composed of a 6 week screening/run-in and 12 week double-blind treatment period (composed of 2 phases; each 6 weeks in duration). Only those participants who do not meet low density lipoprotein-cholesterol (LDL-C) goals at the end of Phase I (Week 6), were eligible to continue into Phase II (Week 12).

Arms: arm 1: Co-administration of EZ 10 mg tablet + Atorva 10 mg tablet; once daily for 6 weeks arm 2: Atorvastatin 20 mg tablet once daily for 6 weeks arm 3: Rosuvastatin 10 mg tablet once daily for 6 weeks arm 4: Participants who had previously received EZ 10 mg + Atorva 10 mg in Phase I and continued on EZ 10 mg + Atorva 10 mg once daily for 6 weeks during Phase II regardless of whether or not LDL-C goals were achieved in Phase I arm 5: Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched to EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II arm 6: Participants who had previously received Atorva 20 mg in Phase I and did not reach LDL-C goal and were switched Atorva 40 mg once daily for 6 weeks in Phase II arm 7: Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and received EZ 10 mg + Atorva 20 mg once daily for 6 weeks in Phase II arm 8: Participants who had previously received Rosuvastatin 10 mg in Phase I and did not reach LDL-C goal and were switched to Rosuvastatin 20 mg once daily for 6 weeks in Phase
Interventions: intervention 1: ezetimibe 10 mg intervention 2: atorvastatin intervention 3: Comparator: rosuvastatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01154985
Conditions: Steatohepatitis
Keywords: omega-3 fatty acids alanine transaminase triglycerides lipids EPA ethyl-EPA ethyl icosapentate Non Alcoholic steatohepatitis Non Alcoholic fatty liver disease fatty acids
Sponsor: Mochida Pharmaceutical Company, Ltd.
Start date: 2010-06-01; Completion date: 2012-10-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a controlled study to determine the effectiveness and safety of ethyl icosapentate (EPA-E) in the treatment of adult patients with non-alcoholic steatohepatitis (NASH).

Detailed description:
This is a phase II, double-blinded, placebo-controlled study to investigate the safety, efficacy, and pharmacokinetic profile of two doses of EPA-E in adult subjects with NASH. Subjects are required to have a liver biopsy with proven NASH in the 6 month period prior to screening. Up to 70 subjects will be enrolled into each treatment arm in a 1:1:1 ratio, for a total of 210 subjects. Subjects will be stratified at randomization by presence or absence of diabetes. Duration of treatment is 12 months.

Arms: arm 1: 3x placebo capsules TID arm 2: 2x EPA-E 300 mg capsules + 1placebo capsule TID arm 3: 3x EPA-E 300 mg capsules TID
Interventions: intervention 1: Placebo capsule intervention 2: EPA-E 300 mg capsule intervention 3: EPA-E 300 mg capsule
Intervention descriptions: intervention 1: 3x Placebo capsules three times a day (TID) for 365 days intervention 2: 2x 300 mg capsules + placebo capsule TID for 365 days intervention 3: 3x 300 mg capsules TID for 365 days

Protocol documents:
Clinical trial NCT01156116
Conditions: Diabetes Sleep Apnea
Keywords: CPAP diabetes sleep apnea
Sponsor: University of Chicago
Start date: 2009-10-01; Completion date: 2012-10-01
Enrollment: 39 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. The objective of this study is to determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA.

Detailed description:
Although obstructive sleep apnea (OSA) is associated with impaired glucose tolerance and diabetes, it remains unclear whether OSA treatment with continuous positive airway pressure (CPAP) has metabolic benefits. To determine the effect of 8-hour nightly CPAP treatment on glucose metabolism in individuals with prediabetes and OSA. In a randomized, controlled parallel group study, 39 participants were randomized (2:1) to receive either 8-hour nightly CPAP (n=26) or oral placebo (n=13). Sleep was polysomnographically recorded in the laboratory on each night. CPAP adherence was ensured by continuous supervision. Participants continued their daily daytime routine activities outside the laboratory. Glucose metabolism was assessed at baseline and after 2-weeks of assigned treatment using both the oral and intravenous glucose tolerance tests (OGTT and ivGTT, respectively). The primary outcome was the overall glucose response as quantified by the area under the curve for glucose during 2-hour oral glucose tolerance testing.

Arms: arm 1: 2 weeks of continuous positive airway pressure (CPAP) treatment which includes wearing the CPAP mask for 8 hours each night arm 2: 2 weeks of oral administration of a placebo tablet 30min before bedtime
Interventions: intervention 1: CPAP mask intervention 2: Placebo
Intervention descriptions: intervention 1: The subjects who are randomized to CPAP treatment will undergo an overnight CPAP titration in the laboratory, which will be performed manually by a registered technician according to American Academy of Sleep Medicine (AASM) guidelines .Subjects will be admitted in the early evening and will receive positive airway pressure education, hands on demonstration, careful mask fitting and acclimatization prior to titration. The goal during the titration will be to determine the optimal CPAP pressure setting that eliminates obstructive respiratory events, restore oxygen saturations and sleep continuity.

\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_ intervention 2: oral placebo tablet

Protocol documents:
Clinical trial NCT01176981
Conditions: Osteosarcoma
Keywords: pediatrics Osteosarcoma Methotrexate Outpatient
Sponsor: The Hospital for Sick Children
Start date: 2010-10-01; Completion date: 2012-10-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary purpose of this study is to determine the safety and feasibility of delivering HDMTX in an outpatient setting.

Detailed description:
High Dose Methotrexate (HDMTX) is an integral part of osteosarcoma therapy whose main toxicities include myelosuppression, mucositis, nephrotoxicity, and hepatitis. In order to deliver HDMTX therapy safely, patients require urinary alkalinization, hydration, monitoring of renal function, therapeutic drug monitoring, and leucovorin rescue. Due to the required supportive care needs, HDMTX has historically been given as an inpatient. In some centers however, HDMTX is being given safely as an outpatient in order to reduce health care costs, improve patient quality of life and to deliver timely therapy with limited inpatient chemotherapy beds available.

Arms: arm 1: This is a single arm study. All subjects enrolled in the study will be in this arm.
Interventions: intervention 1: High Dose Methotrexate
Intervention descriptions: intervention 1: Methotrexate will be given by IV at a dose of 12 gram/m2/dose.

The patient will receive 4-6 hours of hydration with alkalinization, and then HD MTX will be infused over 4 hours. Following this, the patient will be discharged home to receive continuous intravenous hydration through a portable pump. The patient will return to hospital daily for a comprehensive clinical assessment, IV hydration and antiemetics, MTX level and creatinine monitoring until MTX is cleared (3-4 days).

Protocol documents:
Clinical trial NCT01220869
Conditions: Prostate Cancer
Sponsor: Ferring Pharmaceuticals
Start date: 2010-12-01; Completion date: 2012-10-01
Enrollment: 110 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A phase III trial investigating the efficacy and safety of degarelix one-month depot in Taiwanese patients with prostate cancer.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Degarelix
Intervention descriptions: intervention 1: Degarelix was given as subcutaneous (s.c.) injections with a 240 mg starting dose followed one month later by a 80 mg maintenance dose. The maintenance dosing was repeated for an additional 5 months (total treatment period was 168 days).

Protocol documents:
Clinical trial NCT01229436
Conditions: Dupuytren's Contracture
Keywords: Dupuytren's treatment injection recovery health care resources
Sponsor: Pfizer
Start date: 2010-12-01; Completion date: 2012-10-01
Enrollment: 254 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the impact of Xiapex treatment on the range of motion (ROM) of the affected fingers and the patient and physician reported treatment satisfaction and disease severity and their relation to ROM. Recovery to normal activities, recovery time (How long overall, time to use hand, time to return to work or daily activities, amount of work or daily activity time missed or reduced and affects on productivity and daily activities) will be assessed via patient diary. Use of concomitant analgesic medications will be recorded and total healthcare resource utilization (HCRU).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Xiapex
Intervention descriptions: intervention 1: Xiapex 0.58 mg in diluent, 0.25 ml for MP joints and 0.20 ml for PIP joints, injection to cord over joint using either 26 or 27 gauge needle, maximum 3 injections with 30 days interval between injections to any single site, maximum 5 injections in this protocol

Protocol documents:
Clinical trial NCT01254721
Conditions: Acute Bipolar Mania
Keywords: Acute bipolar mania Seroquel XR Seroquel XR plus lithium Quetiapine fumarate
Sponsor: AstraZeneca
Start date: 2010-12-01; Completion date: 2012-10-01
Enrollment: 131 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the efficacy of Seroquel XR monotherapy compared with Seroquel XR plus lithium in the treatment of acute bipolar mania by evaluation of the changes from baseline in Young Mania Ratings Scale (YMRS) total score to Day 29 using the last observation carried forward method.

Detailed description:
A comparison of the effectiveness of Seroquel XR and Seroquel XR plus lithium in patients with acute bipolar mania: An open-label, randomized, parallel groups, rater-blinded, 4 week, multicenter, comparative, phase 4 study.

Arms: arm 1: Seroquel XR tablet arm 2: Seroquel XR + lithium
Interventions: intervention 1: Quetiapine fumarate intervention 2: lithium
Intervention descriptions: intervention 1: eXtended Release(XR) 50mg, 200mg, 300mg and/or 400mg tablet, oral, once daily in the evening, from assignment to the end of the study. intervention 2: 300mg tablet, oral

Protocol documents:
Clinical trial NCT01271686
Conditions: Intraocular Pressure Glaucoma Ocular Hypertension
Sponsor: University of California, San Diego
Start date: 2011-01-01; Completion date: 2012-10-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the 24-hour IOP-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension

Detailed description:
Objectives To investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (IOP) and ocular perfusion pressure (OPP).

Design Prospective, open-label experimental study.

Setting Single tertiary ophthalmic clinic.

Participants Sixteen patients with diagnosed primary open-angle glaucoma (POAG) or ocular hypertension (ages, 49-77 years).

Interventions Baseline data of 24 h IOP in untreated patients were collected in a sleep laboratory. Measurements of IOP were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. After baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h IOP data were collected under the same laboratory conditions.

Primary outcome measure of nocturnal IOP mean under bimatoprost 0.01% treatment was compared with baseline.

Arms: arm 1: bimatoprost 0.01% one time per day at bedtime for 4 weeks.
Interventions: intervention 1: 0.01% bimatoprost
Intervention descriptions: intervention 1: 0.01% bimatoprost once in the evening for 4 weeks

Protocol documents:
Clinical trial NCT01272583
Conditions: Type 1 Diabetes Hypoglycemia
Keywords: Type 1 diabetes DPP-4 inhibitor Glucagon
Sponsor: Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Start date: 2011-03-01; Completion date: 2012-10-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Hypoglycaemia is a well-known complication of insulin treated diabetes. The counterregulatory response to hypoglycaemia, with glucagon as the most important mediator, is initially diminished within a few years of onset of Type 1 diabetes and subsequently lost and thus increasing the risk of hypoglycaemia. Dipeptidyl Peptidase (DPP)-4 inhibitors augment the glucagon response to insulin-induced hypoglycaemia in type 2 diabetes. The investigators hypothesize that treatment with a DPP-4 inhibitor in patients with type 1 diabetes will recover the alpha cell response to hypoglycaemia.

Detailed description:
The 16 type 1 patients will be randomised to one of two treatment sequences: DPP-4 inhibitor followed by placebo or placebo followed by a DPP-4 inhibitor. Each treatment period lasts 6 weeks, so all patients will receive treatment for 12 weeks in total. Induction of hypoglycaemia will take place at 0 weeks, 6 weeks and 12 weeks to determine the glucagon response.

Arms: arm 1: Cross-over, both arms reveived the same intervention in different order. arm 2: Cross-over, both arms reveived the same intervention in different order.
Interventions: intervention 1: Sitagliptin intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg once daily for six weeks intervention 2: placebo, once daily for six weeks

Protocol documents:
Clinical trial NCT01287117
Conditions: Chronic Idiopathic Urticaria
Sponsor: Genentech, Inc.
Start date: 2011-02-01; Completion date: 2012-10-01
Enrollment: 319 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a global Phase III, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of omalizumab administered subcutaneously as an add-on therapy for the treatment of adolescent and adult patients aged 12-75 who have been diagnosed with refractory CIU and who remain symptomatic despite standard-dose H1 antihistamine treatment.

Detailed description:
Type I Error Rate Control Plan

Primary Outcome Measure

In order to maintain an overall type I error rate of 0.05 (2-sided) across the 3 omalizumab dose levels, the testing of the primary Outcome Measure was conducted in the following hierarchical order. A p-value \< 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage.

* Stage 1: Omalizumab 300-mg group vs. placebo
* Stage 2: Omalizumab 150-mg group vs. placebo
* Stage 3: Omalizumab 75-mg group vs. placebo

Secondary Outcome Measures

A hierarchical analysis of the following secondary Outcome Measures was performed for each dose found to be significant in the primary Outcome Measure. A p-value \< 0.05 is only considered statistically significant if statistical significance was claimed at the previous stage.

* Stage 1: Change from baseline to Week 12 in the urticaria activity score over 7 days (UAS7)
* Stage 2: Change from Baseline to Week 12 in the weekly number of hives score
* Stage 3: Time to minimally important difference (MID) response in the weekly itch severity score by Week 12
* Stage 4: Percentage of participants with a UAS7 score ≤ 6 at Week 12
* Stage 5: Percentage of weekly itch severity score MID responders at Week 12
* Stage 6: Change from Baseline to Week 12 in the weekly size of the largest hive score
* Stage 7: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12
* Stage 8: Change from Baseline in the overall dermatology life quality index (DLQI) score at Week 12
* Stage 9: Percentage of complete responders (UAS7 = 0) at Week 12

Arms: arm 1: Participants received placebo subcutaneously every 4 weeks during the 24 week treatment period. arm 2: Participants received omalizumab 75 mg subcutaneously every 4 weeks during the 24 week treatment period. arm 3: Participants received omalizumab 150 mg subcutaneously every 4 weeks during the 24 week treatment period. arm 4: Participants received omalizumab 300 mg subcutaneously every 4 weeks during the 24 week treatment period.
Interventions: intervention 1: Omalizumab intervention 2: Placebo
Intervention descriptions: intervention 1: Omalizumab was supplied as a lyophilized, sterile powder in a single-use vial. intervention 2: Placebo was supplied as a lyophilized, sterile powder in a single-use vial without study drug.

Protocol documents: