ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01452126
Conditions: Surgical Anesthesia
Sponsor: University of New Mexico
Start date: 2011-06-01; Completion date: 2011-09-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a dose finding study to identify the minimum effective anesthetic concentration (MEAC) of ropivacaine to produce insensate body parts sufficient for surgery in supraclavicular and infraclavicular approaches to the brachial plexus, parasacral and popliteal approaches to the sciatic nerve, femoral nerve and transversus abdominis plane (TAP) blocks in adults.

Detailed description:

Arms: arm 1: Sequential allocation of ropivacaine concentration depending on the success or failure of surgical anesthesia of the previous patient
Interventions: intervention 1: Ropivacaine concentration
Intervention descriptions: intervention 1: Single shot preoperative perineural injection of ropivacaine to achieve surgical anesthesia. The concentration of ropivacaine is lowered by 0.05% after every successful surgical anesthesia specific to that block and raised by 0.05% after every unsuccessful surgical anesthesia specific to that block

Protocol documents:
Clinical trial NCT01494649
Conditions: Dentinal Sensitivity Hypersensitivity
Keywords: dentinal hypersensitivity
Sponsor: GlaxoSmithKline
Start date: 2011-09-01; Completion date: 2011-09-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.

Detailed description:

Arms: arm 1: USA marketed toothpaste \[test\] arm 2: USA marketed toothpaste \[negative control\]
Interventions: intervention 1: Test Toothpaste intervention 2: Negative Control Toothpaste
Intervention descriptions: intervention 1: 0.454% stannous fluoride toothpaste intervention 2: 0.76% sodium monofluorophosphate toothpaste

Protocol documents:
Clinical trial NCT01550549
Conditions: Alzheimer Disease Mild Cognitive Impairment Neurodegenerative Diseases
Keywords: Amyloid imaging Positron Emission Tomography 18F-AV-45 florbetapir F 18 Diagnostic imaging
Sponsor: Avid Radiopharmaceuticals
Start date: 2011-08-01; Completion date: 2011-09-01
Enrollment: 151 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will investigate the performance of physician readers trained to read florbetapir-PET scans using electronic media training.

Detailed description:
Avid has previously developed a florbetapir-PET scan binary read methodology and training program, which was successfully applied in studies 18F-AV-45-A08(NCT01565369), 18F-AV-45-A09(NCT01565382) and 18F-AV-45-A16(NCT01447719). In these previous studies, training was conducted in-person. Study 18F-AV-45-PT01 will evaluate an automated version of this training program suitable for web-based distribution. Nuclear medicine physicians will complete the automated training program then read the florbetapir-PET images from 151 subjects with repeat readings of 33 randomly selected images. Readers will rate each case as either positive for significant tracer accumulation in cortical gray matter or negative for significant tracer accumulation in cortical gray matter. The inter-rater reliability, sensitivity and specificity of the readers will be evaluated.

The primary image set for determination of inter-reader agreement is comprised of images from 119 subjects from two previous clinical studies (A07\[NCT00857415\]/A16\[NCT01447719\] and A05\[NCT00702143\]). This included all 59 subjects who came to autopsy in Study A07(NCT00857415) and it's follow-up study, A16(NCT01447719), and a set of 60 cases randomly selected from Study A05(NCT00702143) subjects, including 20 cognitively-normal controls, 20 with mild cognitive impairment) MCI, 20 with AD.

Subsequently, the protocol was amended to include all remaining A05(NCT00702143) MCI patients that were not used in the training program (n=32); 13 of these 32 scans presented for repeat reading (to increase the number of A05 MCI cases with repeated reads to 20). This increased the number of unique cases in the validation dataset to 151 scans with 33 scans repeated yielding a total of 184 scans reviewed by the readers.

Interventions: intervention 1: florbetapir F 18
Intervention descriptions: intervention 1: No study drug will be administered in this study - scans previously acquired in in Study A05(NCT00702143) and A07(NCT00857415) will be read

Protocol documents:
Clinical trial NCT01604109
Conditions: Dental Caries
Keywords: Caries detection/diagnosis/prevention Preventive Dentistry Casien Phosphopeptide Remineralization Clinical trial
Sponsor: Thammasat University
Start date: 2010-07-01; Completion date: 2011-09-01
Enrollment: 296 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if adding daily application of CPP-ACP containing paste for one year is superior to regular fluoride tooth brushing in preventing dental caries in high caries risk Thai preschool children.

Detailed description:
The 6th National Oral Health Survey in Thailand 2006-2007 reported that 3-year-old children who resided in central part have the highest dental caries prevalence of 69.8 percent with dmft affecting 3.63 teeth on average. Fluoride is widely accepted as the most effective tool to caries prevention for initial caries lesions. Current best practice recommends twice-daily tooth brushing with fluoride toothpaste for dentate children.

CPP-ACP can bolster the effects of fluoridated toothpaste alone to prevent caries.Currently, almost all clinical trials have investigated the effectiveness of CPP-ACP containing products in dental caries prevention and enhancing remineralization of initial carious lesion in the permanent dentition of young adolescents. There are no clinical studies of the effect of a CPP-ACP containing product to prevent dental caries in the primary dentition of young children.

Arms: arm 1: 10% w/v Calcium Phosphopeptide Amorphous Calcium Phosphate paste arm 2: the paste without Calcium phosphopeptide - Amorphous Calcium Phosphate
Interventions: intervention 1: 10 % w/v CPP-ACP paste intervention 2: the paste without CPP-ACP
Intervention descriptions: intervention 1: Apply once a day at school by school teacher, following fluoride toothbrushing after lunch intervention 2: Apply once a day at school by school teacher, following fluoride toothbrushing after lunch.

Protocol documents:
Clinical trial NCT01649557
Conditions: Schizophrenia
Keywords: Schizophrenia
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
Start date: 2009-08-01; Completion date: 2011-09-01
Enrollment: 244 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This will be a multicenter, 52 week, open label study to assess the safety and tolerability of oral OPC-34712 (1 to 6 mg) as monotherapy in adult patients with schizophrenia. The study will be conducted on an outpatient basis. Enrollment into the study will be drawn from eligible subjects who have completed participation in Study 331-07- 203 and who, in the investigator's judgment, would benefit from continued treatment with oral OPC-34712.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: OPC-34712
Intervention descriptions: intervention 1: oral administered once daily

Protocol documents:
Clinical trial NCT01853254
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2003-09-01; Completion date: 2011-09-01
Enrollment: 272 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label, non-randomized, single arm study will provide treatment or re-treatment with Pegasys (peginterferon alfa-2a) as monotherapy or in combination with Copegus (ribavirin) to patients with chronic hepatitis C infection. Patients who have received prior Pegasys monotherapy or combination therapy or who were considered eligible for treatment with Pegasys in previous donor protocols will be eligible to participate in this study. Treatment will be on investigator's decision according to the approved label for up to 48 weeks, with a 24-week safety follow-up.

Detailed description:

Arms: arm 1: The treating investigator decided the most appropriate treatment. It was recommended that participants receive combination therapy.
Interventions: intervention 1: Peginterferon alfa-2a intervention 2: Ribavirin
Intervention descriptions: intervention 1: Both combination and monotherapy for both genotype 2/3 and genotype non-2/3: 180 μg subcutaneously once weekly. intervention 2: For genotype 2/3, 800 mg orally daily, in 2 split doses for 24 weeks. For genotype non-2/3, 1000 mg orally daily for participants weighing \< 75 kg or 1200 mg orally daily for participants weighing ≥ 75 kg, in 2 split doses, for 48 weeks.

Protocol documents:
Clinical trial NCT01976806
Conditions: Periodontitis Gingivitis Inflammation
Keywords: Docosahexaenoic acid DHA Periodontitis Gingivitis Omega-3 fatty acid Fish oil
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2009-06-01; Completion date: 2011-09-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether docosahexaenoic acid (DHA) is effective in the treatment of periodontitis in adults.

Detailed description:
1. The primary aim of this study is to investigate the effect of docosahexaenoic acid (DHA; 2 gm/day) plus low dose aspirin (ASA 81 mg/day)compared to ASA alone on periodontitis over three months. Our hypothesis is that DHA plus ASA will improve periodontitis as measured by objective periodontal exam, including decreased pocket depth (mm), gingival index (0-3), plaque index (0-3) and bleeding on probing (yes/no) compared to ASA alone.
2. Assess the effect of DHA and ASA exposure on markers of local inflammation, including gingival crevicular fluid (GCF) CRP, IL-1 beta and IL-6 three months after exposure to DHA plus ASA compared to ASA alone.
3. Evaluate potential mechanisms through changes in the periodontal microbial flora which may occur as a result of exposure to DHA and ASA compared to ASA alone. Our hypothesis is that there will be a substantial post therapy change in the microbial flora of dental plaques, favoring bacteria associated with a lower systemic inflammatory state.
4. Assess the effect of DHA and ASA exposure on markers of systemic inflammation, including serum C-Reactive Protein (CRP), interleukin-6 (IL-6) and vascular adhesion molecule (VCAM) compared to ASA. Our hypothesis is that there will be a decrease in serum CRP, IL-6 and VCAM three months after exposure to DHA plus ASA compared to ASA alone.
5. Assess the effect of DHA and ASA exposure on markers of systemic bone turnover, including urine N-terminal telopeptide (NTx) compared to ASA. Our hypothesis is that there will be a decrease in urine NTx three months after exposure to DHA plus ASA compared to ASA alone.

Arms: arm 1: Aspirin 81 mg 1 tablet by mouth daily and Docosahexanoic acid (DHA) 500 mg 4 capsules by mouth daily (total daily dose of 2 grams DHA) for 3 months arm 2: Aspirin 81 mg by mouth daily and placebo (50% corn oil/50% soybean oil) 4 capsules by mouth daily for 3 months
Interventions: intervention 1: Aspirin intervention 2: Docosahexaenoic acid intervention 3: Placebo (for Docosahexaenoic acid)
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: Placebo (corn/soybean oil) capsules manufactured to look identical to DHA capsules

Protocol documents:
Clinical trial NCT02353572
Conditions: Plasma Cell Myeloma Plasmacytosis Recurrent Plasma Cell Myeloma Smoldering Plasma Cell Myeloma
Sponsor: University of Colorado, Denver
Start date: 2009-11-01; Completion date: 2011-09-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase I/II trial studies the safety and best dose of melphalan and bortezomib when given prior to an autologous stem cell transplant and to see how well they work in treating patients with multiple myeloma. Drugs used in chemotherapy, such as melphalan, work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading. Bortezomib may help melphalan work better by making cancer cells more sensitive to the drug. Giving chemotherapy before an autologous hematopoietic stem cell transplant helps kill any cancer cells that are in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. After treatment, stem cells are collected from the patient's blood and stored. More chemotherapy is then given to prepare the bone marrow for the stem cell transplant. The stem cells are then returned to the patient to replace the blood-forming cells that were destroyed by the chemotherapy. Giving melphalan together with bortezomib prior to autologous hematopoietic stem cell transplant may be a better treatment for multiple myeloma.

Detailed description:
This is a phase I, dose-escalation study of melphalan and bortezomib followed by a phase II study.

Patients receive melphalan intravenously (IV) continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also receive dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients undergo autologous hematopoietic stem cell transplant. Eligible patients may undergo a second transplant 2-4 months after completion of the first transplant.

After completion of study treatment, patients are followed up monthly for at least 1 year and then every 3-6 months thereafter.

Arms: arm 1: Patients receive melphalan IV continuously on days -5 to -2 and bortezomib IV over 3-5 seconds on days -4 and -1. Patients also receive dexamethasone IV on day -1 prior to the second dose of bortezomib. Beginning two days after completion of melphalan infusion, patients undergo autologous hematopoietic stem cell transplant. Eligible patients may undergo a second transplant 2-4 months after completion of the first transplant.
Interventions: intervention 1: Melphalan intervention 2: Bortezomib intervention 3: Dexamethasone intervention 4: Autologous Transplant
Intervention descriptions: intervention 1: Given IV intervention 2: Given IV intervention 3: Given IV intervention 4: Undergo autologous hematopoietic stem cell transplant

Protocol documents:
Clinical trial NCT02389452
Conditions: Osteoarthritis
Sponsor: Genzyme, a Sanofi Company
Start date: 2010-02-01; Completion date: 2011-09-01
Enrollment: 394 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Primary Objective:

To evaluate the safety and efficacy of a single 6 mL intraarticular (IA) injection of Synvisc-One in participants in India with symptomatic osteoarthritis (OA) of the knee(s).

Secondary Objective:

To evaluate the safety and short-term efficacy of a repeat treatment with Synvisc-One.

Detailed description:
A period of approximately 19 months was anticipated from the time the first participants was enrolled in the study to the completion of the study (last participant out). Individual participant participation lasted from 7 to 13 months depending on the timing of repeat treatment.

Arms: arm 1: Single 6 mL IA injection of Synvisc-One (48 mg of cross-linked hylan polymer) at Day 0 (Initial Treatment). Participants received repeat injection based on physician's discretion of safety and efficacy (no major safety concerns and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) A1 subscore \[measurement of pain while walking on flat surface\] between 40-80 mm, measured on a 0-100 mm scale with 0 represents no pain and 100 represents worst possible pain) at Week 26, 39 or 52 (Repeat treatment).
Interventions: intervention 1: Synvisc-One
Intervention descriptions: intervention 1: intraarticular injection

Protocol documents:
Clinical trial NCT01186770
Conditions: Opioid-Induced Constipation
Keywords: Treatment of Opioid-Induced Constipation in Participants with Chronic, Non-Malignant Pain
Sponsor: Bausch Health Americas, Inc.
Start date: 2010-09-01; Completion date: 2011-09-08
Enrollment: 804 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
MNTX 3201 is a Phase 3, international, multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the safety and efficacy of oral MNTX for the treatment of opioid induced constipation in participants with chronic, non-malignant pain.

Detailed description:

Arms: arm 1: Participants will receive methylnaltrexone (MNTX) 150 milligrams (mg) (1 tablet of MNTX 150 mg and 2 matching placebo tablets) orally once daily (QD) for 28 days (4 weeks), then MNTX tablets at a dose as needed (PRN) for remaining 56 days (8 weeks). arm 2: Participants will receive MNTX 300 mg (2 tablets of MNTX 150 mg each and 1 matching placebo tablet) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks). arm 3: Participants will receive MNTX 450 mg (3 tablets of MNTX 150 mg each) orally QD for 28 days (4 weeks), then MNTX tablets at a dose PRN for remaining 56 days (8 weeks). arm 4: Participants will receive 3 tablets of placebo matched to MNTX orally QD for 84 days (12 weeks).
Interventions: intervention 1: Methylnaltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: Methylnaltrexone will be administered as per the dose and schedule specified in the respective arms. intervention 2: Placebo matching to methylnaltrexone will be administered as per the schedule specified in the respective arms.

Protocol documents:
Clinical trial NCT00986102
Conditions: Pneumonia Pneumonia, Ventilator-Associated Urinary Tract Infections
Keywords: Carbapenem Doripenem Doribax Nosocomial pneumonia, Intra-abdominal infections Urinary tract infection
Sponsor: Janssen Research & Development, LLC
Start date: 2009-07-17; Completion date: 2011-09-09
Enrollment: 216 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to understand the utilization patterns of doripenem in Asia Pacific, including the profile of the patients treated with carbapenems.

Detailed description:
This is a Phase 4, prospective, open-label, non-comparative, multicenter study to characterize the usage of doripenem in selected hospitals in the Asia Pacific region. Doripenem belongs to the carbapenem class which is a broad-spectrum antibiotic given to treat patients with serious infections, such as pneumonia and complicated intra-abdominal infections. Physicians in the selected hospital or hospital unit will refer potential patients to the study team. Patients will include men and women 18 years of age and older, hospitalized either in the Intensive Care Unit (ICU) or ward, with a diagnosis of pneumonia, complicated intra-abdominal infections and complicated urinary tract infections. The study has 3 phases: a pretreatment phase with a 1-day screening/baseline visit, a treatment phase of 5 to 14 days, and a post-treatment phase consisting of an end-of-treatment (EOT)/early withdrawal visit to be conducted within 24 hours after the last dose of antimicrobial therapy, a test of cure (TOC) visit 7 to 14 days after EOT, a Day 28 visit, and a post-discharge visit 28 days after discharge from the hospital. Usage of Doripenem in terms of approved indications, mode of usage, duration of antibiotic therapy, and patient characteristics will be assessed. Safety will be assessed through monitoring for adverse events, serial physical examinations, and the collection of conventional laboratory data (chemistry panel, complete blood count with differential). Being a prospective study, patient data will be gathered as the patients are enrolled, starting with their present condition and following them until duration of the study. The study will not compare Doripenem with other antibiotics for the primary endpoint. One vial (500mg) of doripenem intravenously (by injection) every 8 hours for 5 to 14 days

Arms: arm 1: doripenem 500mg vial by injection every 8 hours for 5 to 14 days
Interventions: intervention 1: doripenem
Intervention descriptions: intervention 1: 500mg vial by injection every 8 hours for 5 to 14 days

Protocol documents:
Clinical trial NCT01098240
Conditions: Major Depressive Disorder
Keywords: Antidepressant Augmentation
Sponsor: Pfizer
Start date: 2010-06-14; Completion date: 2011-09-12
Enrollment: 297 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objectives of this study are to: 1) Evaluate the efficacy of CP 601,927 compared to placebo in the augmentation of antidepressant therapy (ADT) in patients with Major Depressive Disorder (MDD) using the Montgomery Asberg Depression Rating Scale (MADRS). 2) Evaluate the safety and tolerability of CP 601,927 in patients with MDD on ADT.

Detailed description:
The study was stopped at interim analysis in August 2011, as stopping criteria for futility were met. There was no statistically significant change on the primary efficacy scale in favor of the drug. There was a very small chance that any additional data could change the study overall outcome. There were no concerns regarding subject safety.

Arms: arm 1: CP-601,927 arm 2: Placebo
Interventions: intervention 1: CP-601,927 intervention 2: Placebo
Intervention descriptions: intervention 1: CP-601,927 1-2 mg twice per day, oral 1 mg tablets, for 6 weeks. intervention 2: Matching placebo tablets, taken orally, twice per day, for 6 weeks.

Protocol documents:
Clinical trial NCT00885170
Conditions: Osteoporosis
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-04-13; Completion date: 2011-09-15
Enrollment: 246 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study will evaluate the both the efficacy of odanacatib on Bone Mineral Density (BMD) and the safety of odanacatib for postmenopausal osteoporosis in patients previously treated with alendronate. The primary hypothesis of the trial is that treatment with odanacatib 50 mg once weekly will increase bone mineral density at the femoral neck compared to placebo at the end of 24 months.

Detailed description:

Arms: arm 1: Odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg. arm 2: Placebo to odanacatib 50 mg tablets once weekly for 24 months. Vitamin D3 (dietary supplement), two 2800 IU tablets, taken once weekly for 24 months. Participants received calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.
Interventions: intervention 1: Odanacatib intervention 2: Placebo intervention 3: Vitamin D3 intervention 4: Calcium
Intervention descriptions: intervention 1: Odanacatib 50 mg tablets once weekly for 24 months intervention 2: Placebo to odanacatib 50 mg tablets once weekly for 24 months intervention 3: Vitamin D3, two 2800 IU tablets, taken once weekly for 24 months intervention 4: Participants will receive calcium carbonate supplements as needed to ensure a daily calcium intake of 1200 mg.

Protocol documents:
Clinical trial NCT01086384
Conditions: Asthma
Sponsor: GlaxoSmithKline
Start date: 2010-02-22; Completion date: 2011-09-15
Enrollment: 2020 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will establish the safety as well as demonstrate benefit of the addition of a LABA to an ICS by utilizing an endpoint (time to first severe asthma exacerbation) that informs on both safety and efficacy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Fluticasone Furoate/GW642444 intervention 2: Fluticasone furoate
Intervention descriptions: intervention 1: Combination inhaled corticosteroid and long-acting beta2-agonist intervention 2: Inhaled corticosteroid

Protocol documents: