ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02328404
Conditions: Polycystic Ovary Syndrome Hypovitaminosis D
Keywords: Vitamin D deficiency hypovitaminosis D Biodal 25 hydroxy Vitamin D 25hydroxyvitamin D 25(OH)D PCOS insulin resistance BMI chromium levels vitamin D 3 cholecalciferol 50,000 IU
Sponsor: Hayat Pharmaceutical Co. PLC
Start date: 2014-02-01; Completion date: 2014-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a prospective double-blind, randomized, parallel-group, placebo-controlled trial designed to examine the effect of supplementation with 50,000 IU vitamin D3 for 3 months on Polycystic Ovary Syndrome (PCOS) prognosis, serum 25-Hydroxy Vitamin D (25(OH)D) level, serum chromium level, insulin resistance, and Body Mass Index (BMI), in 60 overweight Jordanian female patients diagnosed with PCOS and with hypovitaminosis D.

Detailed description:
This study is designed to assess the safety and efficacy of 50,000 IU vitamin D supplementation once weekly for 3 months on improvement in PCOS prognosis and improvement in serum 25(OH)D levels in 60 overweight Jordanian females (defined as having a BMI 25-30kg/m2), diagnosed with PCOS (based on Rotterdam criteria), and with hypovitaminosis D (defined as a serum 25(OH)D level \< 20 ng/mL), compared with placebo.

Evaluation of the safety and efficacy of the dosing regimen will be conducted over 6 study visits during which clinical and biochemical signs of PCOS as well as serum 25(OH)D level, serum chromium level, insulin resistance, and BMI will be evaluated.

The measurements will be collected as follows : day (-7) during screening , Day (0) base line measurements , Day (30) , Day(60), Day (90), day (104).

Arms: arm 1: 50,000 IU Vitamin D3 tablet given orally once weekly for 3 months arm 2: Placebo tablet given orally once weekly for 3 months
Interventions: intervention 1: 50,000 IU vitamin D3 intervention 2: Placebo
Intervention descriptions: intervention 1: Film-coated tablet Biodal 50,000 IU containing cholecalciferol 50,000 IU intervention 2: Placebo film-coated tablet of Biodal 50,000 IU

Protocol documents:
Clinical trial NCT02336958
Conditions: Carotid Stenosis
Keywords: cervical plexus regional anesthesia ultrasound carotid surgery
Sponsor: Helios Research Center
Start date: 2013-09-01; Completion date: 2014-12-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
For ultrasound guided intermediate cervical plexus block this randomized comparison is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

Detailed description:
The innervation of the neck is complex and involves the cervical and the brachial plexus as well as cranial nerves. So is the wall of the carotid arteries innervated by vagal and glossopharyngeal nerve as well as the sympathetic trunk. When carotid surgery was performed under regional anesthesia, so additional infiltration of local anesthetic by the surgeon was common, particularly during preparation of the carotid arteries.

Introduction of ultrasound guidance made it possible to guide the needle directly to the vascular wall. But this procedure is considered very demanding, because of guiding the needle in an anatomical region with artifacts (because of calcification), sudden movements (e.g. because of swallowing) and compromised coagulation (antithrombotic medication). On the other side there are no clinical data proving the benefit of an additional perivascular infiltration with local anesthetic. Therefore, this investigation is testing the hypothesis, that an additional perivascular infiltration is associated with increased block quality.

Arms: arm 1: Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml ropivacaine 0.75%. arm 2: Ultrasound guided intermediate cervical plexus block: 20ml ropivacaine 0.75%. Ultrasound guided perivascular/pericarotidal infiltration: 5ml saline 0.9%.
Interventions: intervention 1: intermediate cervical plexus block ropivacaine intervention 2: pericarotidal infiltration (active comparator) ropivacaine intervention 3: jugular infiltration prilocaine intervention 4: pericarotidal infiltration (placebo comparator) saline
Intervention descriptions: intervention 1: 20ml ultrasound guided intermediate cervical plexus block. intervention 2: 5ml ropivacaine 0.75% (active comparator): pericarotidal infiltration. intervention 3: 5ml prilocaine 1% jugular infiltration for wound drainage. intervention 4: 5ml saline 0.9% (placebo comparator): pericarotidal infiltration.

Protocol documents:
Clinical trial NCT02355977
Conditions: Chronic Periodontitis
Keywords: Chronic periodontitis Minocycline Surface and root planning Pocket depth Sulcus bleeding index Prevotella intermedia
Sponsor: Zhejiang University
Start date: 2013-06-01; Completion date: 2014-12-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the respective or combinatory efficacy of locally delivered 2% Minocycline (MO) and surface and root planning (SRP) by assessing both clinical parameters and the loads of four main periodontal pathogens in treating chronic periodontitis.

Detailed description:
In this randomized clinical trial, the investigators will evaluate the respective or combinatory efficacy of minocycline and scaling and root planning in the aspects of both clinical parameters \[Pocket depth (PD) and sulcus bleeding index (SBI)\] and the loads of four main periodontal pathogens \[Aggregatibacter actinomycetemcomitans (Aa), Fusobacterium nucleatum (Fn), Porphyromonas gingivalis (Pg) and Prevotella intermedia (Pi)\]. Real-time quantitative PCR (qRT-PCR) will be used as a powerful tool with high sensitivity and specificity to quantitatively assess target periodontal bacteria in a period of 7 days. The investigators will also try to correlate the reduction of either total or respective bacteria with the improvements of clinical parameters, with an aim to uncovering the potential microbiological mechanism accounting for the efficacy of a therapy.

Arms: arm 1: surface and root planning is performed in a single-visit, one-stage, full mouth pattern using periodontal ultrasonic scaler (Satelec, Mérignac, France) arm 2: Locally delivered minocycline is administered directly into the periodontal pocket up to the gingival margin of the selected teeth arm 3: surface and root planning+locally delivered minocycline is the combined administration of both surface and root planning and locally delivered minocycline.
Interventions: intervention 1: minocycline intervention 2: surface and root planning
Intervention descriptions: intervention 1: Periocline dental ointment intervention 2: surface and root planning

Protocol documents:
Clinical trial NCT02366689
Conditions: Dental Plaque Gingivitis
Sponsor: Colgate Palmolive
Start date: 2014-06-01; Completion date: 2014-12-01
Enrollment: 179 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this clinical research study is to assess the efficacy of a commercially available triclosan/copolymer toothpaste compared to a commercially available oral hygiene multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium chloride relative to a negative control regimen in reducing established dental plaque and gingivitis over three and six months of assigned product use.

Detailed description:

Arms: arm 1: Triclosan/fluoride toothpaste arm 2: stannous fluoride toothpaste + cetylpyridinium chloride Mouthwash arm 3: Fluoride only toothpaste + Fluoride only Mouthwash
Interventions: intervention 1: Triclosan/fluoride toothpaste intervention 2: stannous fluoride toothpaste intervention 3: fluoride only toothpaste intervention 4: Cetylpyridinium chloride mouthwash intervention 5: Fluoride only mouthwash
Intervention descriptions: intervention 1: Brush whole mouth with Total toothpaste (triclosan/fluoride) using Total 360 toothbrush for 1 minute, 2 times/day for 6 months (study duration). intervention 2: Brush whole mouth with Crest Pro-Health toothpaste using an Oral B Pro-Health toothbrush for 1 minute, 2 times/day for 6 months (study duration). intervention 3: Brush whole mouth with Crest Cavity Protection toothpaste using an Oral B Indicator toothbrush for 1 minute, 2 times/day for 6 months (study duration). Immediately after each brushing, rinse whole mouth with 20 ml of Crest fluoride Mouthwash for 30 seconds. intervention 4: Immediately after each brushing with Crest Pro-Health toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health Mouthwash for 30 seconds. intervention 5: Immediately after each brushing with Crest Cavity Protection toothpaste, rinse whole mouth with 20 ml of Crest Pro-Health For Me mouthwash for 30 seconds.

Protocol documents:
Clinical trial NCT02384070
Conditions: Coronary Artery Disease
Sponsor: Odessa Heart Institute
Start date: 2009-01-01; Completion date: 2014-12-01
Enrollment: 300 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Despite the routine use of procedural anti-coagulation and anti-platelet therapy for FFR calculation, no study has evaluated the optimal anti-thrombotic regimen in patients undergoing FFR. Therefore, the aim of the Evaluation of Simplified Anti-Thrombotic Therapy for Coronary Fractional Flow Reserve (SMART-FFR) study was to evaluate the safety of using a simplified anti-thrombotic regimen with only upstream dual anti-platelet therapy (DAT) with aspirin and clopidogrel, compared with anticoagulation plus single- or- DAT therapy in patients with intermediate coronary artery stenosis undergoing FFR calculation during elective coronary angiography.

Detailed description:

Arms: arm 1: Received upstream aspirin plus clopidogrel with no intra-procedural anticoagulation for the FFR calculation with a saline bolus and drip used for placebo anticoagulation during the procedure to blind the operator arm 2: Received upstream aspirin and clopidogrel plus intra-procedural anticoagulation with bivalirudin for FFR calculation arm 3: Received only upstream single anti-platelet therapy with aspirin plus intra-procedural anticoagulation for the FFR calculation with bivalirudin
Interventions: intervention 1: FFR intervention 2: Aspirin intervention 3: Clopidogrel intervention 4: Bivalirudin
Intervention descriptions: intervention 1: Fractional flow reserve tracings were calculated using a Volcano pressure wire intra-coronary system after ensuring proper calibration of the aortic pressure transducer and the guidewire, using 6 Fr-guide catheters. Before crossing the stenosis, baseline pressure was measured by the guide catheter and the pressure guidewire were equalized according to the manufacturer's specifications. After advancing the pressure sensor across the stenosis, coronary hyperemia was induced using intravenous adenosine (140μg/kg/min until a steady state was reached for at least 3 minutes). Fractional flow reserve was considered positive if it was less than 0.80. intervention 2: All patients received a chewable aspirin of 325 mg at least 6 hours before the procedure intervention 3: All patient receiving clopidogrel, were loaded with 600 mg at least 6 hours before the procedure intervention 4: Dosed based on the weight at 0.75 mg/kg I.V. bolus dose followed by a 1.75 mg/kg/hr I.V. infusion for the duration of the procedure

Protocol documents:
Clinical trial NCT02430389
Conditions: Surgery
Keywords: hemodynamic stability remifentanil
Sponsor: Northwestern University
Start date: 2012-07-01; Completion date: 2014-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To identify a better method using a combination of routine anesthetic drugs to improve hemodynamic stability during Mayfield head pinning for craniotomy surgery.

Detailed description:
A randomized, placebo-controlled, double-blinded comparative effectiveness study to test hypothesis that addition of remifentanil bolus to a standard anesthetic drug regimen will better attenuate the hemodynamic response to the noxious stimulus of Mayfield head pin insertion than the standard anesthetic drug regimen.

Arms: arm 1: Intravenous bolus of 10 mL of remifentanil (0.7 mcg/kg based on ideal body weight) will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg). arm 2: Intravenous bolus of 10 mL normal saline from study syringe will be given ninety seconds before head pinning as well as an intravenous bolus of propofol (0.7 mg/kg).
Interventions: intervention 1: Remifentanil intervention 2: Normal Saline
Intervention descriptions: intervention 1: Ninety seconds before pinning, an IV bolus of 10 mL of remifentanil (0.7 µg•kg-1 based on ideal body weight) will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered intervention 2: Ninety seconds before pinning, an IV bolus of 10 mL of normal saline will be administered from the study syringe and an IV bolus of propofol (0.7 mg•kg-1) will be administered

Protocol documents:
Clinical trial NCT02503865
Conditions: Metabolic Syndrome
Keywords: Metabolic syndrome Diabetes mellitus, Hypertension Overweight analimentary detoxication
Sponsor: Nazarbayev University
Start date: 2003-01-01; Completion date: 2014-12-01
Enrollment: 351 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Metabolic syndrome: aetiology, pathogenesis, diagnosis, clinical management and prognosis

Detailed description:
Purpose: To create the complex scientifically proved concept of Metabolic syndrome (МS) development based on elaboration of the new methods of clinical diagnostics of МS components and highly effective МS clinical management in comparative studying of clinical, laboratory and cost effectiveness.

Participants and methods: This clinical study included 351 adults (184 female) in the Scientific research institute of cardiology and internal diseases (Almaty, the Republic of Kazakhstan). Statistical analysis was performed using Microsoft Excel-2008 in updating Lapach, Chubenko et al (2000) and SPSS for Windows v.17.0.

Arms: arm 1: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin arm 2: Vegetables and salt diet arm 3: 64 healthy people
Interventions: intervention 1: Xenical, Pionorm, Diroton, Diltiazem, Atorvastatin intervention 2: "Analimentary detoxication"
Intervention descriptions: intervention 1: Xenical (Orlistat) - 120 mg/day in integration of Pionorm (Pioglitazone hydrochlorid) - 30 mg/day, Diroton (Lizinopril) - 20 mg/day, Diltiazem - 90 mg/day, Atorvastatin (Liprimar) - 40 mg/day intervention 2: Vegetable and salt diet

Protocol documents:
Clinical trial NCT02533401
Conditions: Lymphocytic Leukemia, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2006-02-01; Completion date: 2014-12-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of rituximab in combination with chemotherapy (fludarabine and cyclophosphamide) in participants with B-cell CLL.

Detailed description:

Arms: arm 1: Participants will receive rituximab (375 milligrams per meter-squared \[mg/m\^2\] intravenously \[IV\]) on Cycle 1 Day 1, followed by fludarabine (25 mg/m\^2 once daily IV) and cyclophosphamide (250 mg/m\^2 once daily IV) for Days 2 to 4 of Cycle 1. Then rituximab (500 mg/m\^2 IV) will be administered on Day 1 of Cycles 2 to 6, followed by IV fludarabine (25 mg/m\^2 once daily IV) and cyclophosphamide (250 mg/m\^2 once daily IV) on Days 1 to 3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length, and the overall duration of treatment will be approximately 6 months.
Interventions: intervention 1: Cyclophosphamide intervention 2: Fludarabine intervention 3: Rituximab
Intervention descriptions: intervention 1: Cyclophosphamide will be administered IV at 250 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length. intervention 2: Fludarabine will be administered IV at 25 mg/m\^2/day on Day 2-4 of Cycle 1 and then on Day 1-3 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length. intervention 3: Rituximab will be administered IV at 375 mg/m\^2 on Day 1 of Cycle 1 and then at 500 mg/m\^2 on Day 1 of Cycles 2 to 6. Each cycle will be 28 days or 4 weeks in length.

Protocol documents:
Clinical trial NCT02578186
Conditions: Occasional Sleeplessness
Sponsor: Procter and Gamble
Start date: 2013-11-01; Completion date: 2014-12-01
Enrollment: 33 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The present study was conducted to investigate the impact of diphenhydramine hydrochloride on the ability to initiate sleep.

Detailed description:
Diphenhydramine hydrochloride (herein referred to as diphenhydramine) is an antihistamine of the ethanolamine classes with known sleep-inducing properties and is approved by the Food \& Drug Administration to reduce the time to sleep onset in individuals having difficulty falling asleep. The goal of the study is to investigate diphenhydramine versus placebo with regard to several sleep parameters, including time to sleep onset, in healthy adult subjects suffering from occasional sleeplessness.

Arms: arm 1: Diphenhydramine (50 mg) elixir taken when subjects had trouble falling asleep arm 2: Placebo elixir taken when subjects had trouble falling asleep
Interventions: intervention 1: Diphenhydramine Hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: 30 mL at bedtime intervention 2: 30 mL at bedtime

Protocol documents:
Clinical trial NCT02714504
Conditions: Fusariosis Onychomycosis
Keywords: Prophylaxis
Sponsor: Universidade Federal do Rio de Janeiro
Start date: 2008-08-01; Completion date: 2014-12-01
Enrollment: 239 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened with dermatologic examination. In the presence of any skin lesion in the extremities, direct exam and fungal culture will be performed. If these exams indicate the presence of Fusarium species, patients will receive anti-mold azole prophylaxis

Detailed description:
Patients admitted for autologous or allogeneic hematopoietic cell transplantation, induction-remission chemotherapy for acute myeloid leukemia, myelodysplasia or acute lymphoid leukemia, or to receive immunosuppressive therapy for aplastic anemia will be screened on admission. Patients may be included more than once, provided that a new treatment is administered and \>30 days elapses from one to other admission (episode).

Screening will consist of a thorough physical examination in the extremities. In case of a skin lesion, direct exam and fungal culture will be performed. Nail samples will be obtained by scrapping the nails with a curette, and samples from interdigital areas will be obtained using swabs.

In a first phase no intervention will be performed. In a second phase, if direct exam and /or culture indicate the presence of Fusarium spp., primary antifungal therapy with an anti-mold azole (voriconazole (200 mg BID) or posaconazole (200 mg TID) will be started.

Patients will be followed until discharge. The primary endpoint is invasive fusariosis, comparing the observational period with the intervention period.

Arms: arm 1: No anti-mold prophylaxis given on the basis of results of baseline presence of skin lesions arm 2: Anti-mold prophylaxis with either voriconazole or posaconazole for patients with baseline skin lesions in the extremities positive for Fusarium spp.
Interventions: intervention 1: Voriconazole or posaconazole
Intervention descriptions: intervention 1: Azole with activity against molds

Protocol documents:
Clinical trial NCT02788357
Conditions: Atomoxetine Hydrochloride Placebos
Keywords: motor training motor recovery human neuroplasticity transcranial magnetic stimulation
Sponsor: Lumy Sawaki
Start date: 2006-11-01; Completion date: 2014-12-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This proposal evaluates the safety and effectiveness of a noradrenergic drug named atomoxetine combined with motor training to enhance cortical plasticity and improve hand function after stroke.

Detailed description:
Extensive studies in laboratory animals and humans over the last ten years indicate that some medications, especially amphetamine, given with specific physical therapy may improve motor learning (and therefore recovery from stroke) more than physical therapy alone. However, the number of patients in clinical trials who have received physical therapy and amphetamine is very small, for two reasons: because amphetamine may interact with many other medications that stroke patients are already taking, and because its potential for addiction precludes its use on a daily basis. The investigators now wish to evaluate the effectiveness of a more selective medication, atomoxetine, known to have many fewer side effects and no potential for drug addiction. The proposed mechanism by which amphetamine enhances recovery is by increasing central levels of norepinephrine. While the investigators already know that this drug is more selective than amphetamine, the investigators would like to evaluate its effects on hand motor learning and motor recovery in chronic stroke patients in a clinical setting.

Arms: arm 1: 40 mg atomoxetine paired with task-oriented therapy for 10 consecutive weekdays arm 2: Placebo capsules paired with task-oriented therapy for 10 consecutive weekdays
Interventions: intervention 1: Atomoxetine intervention 2: Placebo
Intervention descriptions: intervention 1: Subjects will receive a single daily oral dose of 40 mg of atomoxetine. We will administer 2 hours/daily of motor training sixty minutes after drug intake. intervention 2: Subjects will receive a single daily oral dose of placebo. We will administer 2 hours/daily of motor training sixty minutes after drug intake.

Protocol documents:
Clinical trial NCT01802775
Conditions: Peripheral Arterial Disease
Sponsor: Daiichi Sankyo
Start date: 2013-02-06; Completion date: 2014-12-03
Enrollment: 203 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is a randomized, open-label, blinded endpoint, parallel-group, active-control, multi-center, proof-of-concept study in subjects with Peripheral Arterial Disease (PAD), designed to assess the safety and potential efficacy of adding edoxaban to aspirin following femoropopliteal endovascular intervention, with or without stent placement, relative to current treatment practice with clopidogrel and aspirin.

Detailed description:

Arms: arm 1: Open label edoxaban will be provided. Subjects randomized to this treatment arm will receive edoxaban 60 mg once daily (QD) (two 30 mg tablets) for a total of approximately 3 months on a background of aspirin 100 mg QD. arm 2: Open label clopidogrel will be provided. Subjects randomized to this treatment arm will receive clopidogrel 75 mg QD (one 75 mg tablet) for a total of approximately 3 months on a background of aspirin 100 mg QD. A loading dose of clopidogrel 300 mg (four 75mg tablets) will be given to subjects as the first dose as early as possible after adequate hemostasis (i.e., within 4 hours of hemostasis).
Interventions: intervention 1: edoxaban intervention 2: Clopidogrel intervention 3: Aspirin
Intervention descriptions: intervention 1: None intervention 2: 75mg tablet intervention 3: None

Protocol documents: