ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02283827
Conditions: Epilepsy
Sponsor: Bial - Portela C S.A.
Start date: 2007-01-01; Completion date: 2007-03-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design

Detailed description:
Single centre, open-label, multiple doses, two parallel study groups each receiving two formulations in a one-sequence design:

Group A: Pre-treatment with ESL, treatment with ESL and ascending doses of phenytoin (PHT) in last phases;

Group B: Pre-treatment with PHT, treatment with PHT and ascending doses of ESL in last phases

Arms: arm 1: Day 1 to 2: Pre-treatment 1: 600 mg ESL Day 3 to 8: Treatment 1: 1200 mg ESL Day 9 to 10: Treatment 1 + Pre-treatment 2: 1200 mg ESL+ 100 mg PHT Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + 300 mg PHT arm 2: Day 1 to 2: Pre-treatment 2: 100 mg PHT Day 3 to 8: Treatment 2: 300 mg PHT Day 9 to 10: Treatment 2 + Pre-treatment 1: 300 mg PHT + 600 mg ESL Day 11 to 27: Treatment 1 + Treatment 2: 1200 mg ESL + 300 mg PHT
Interventions: intervention 1: BIA 2-093 intervention 2: Phenytoin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00559468
Conditions: Anesthesia, General
Sponsor: Merck Sharp & Dohme LLC
Start date: 2006-12-07; Completion date: 2007-03-02
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of the trial was to show equivalence in recovery from neuromuscular block after a single dose of 4.0 mg/kg sugammadex, administered at first twitch (T1) 3-10% after continuous infusion of rocuronium, between participants receiving maintenance anesthesia using propofol and participants receiving sevoflurane, to investigate the safety and to compare the plasma levels of rocuronium in participants after continuous infusion of rocuronium and before the administration of sugammadex, under either propofol or sevoflurane anesthesia.

Detailed description:

Arms: arm 1: After receiving sevoflurane and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered. arm 2: After receiving propofol and the last dose of rocuronium, at the reappearance of first twitch (T1; 3-10% starting amplitude), a dose of 4.0 mg/kg sugammadex was administered.
Interventions: intervention 1: Sugammadex intervention 2: Rocuronium intervention 3: Sevoflurane intervention 4: Propofol
Intervention descriptions: intervention 1: Single dose 4.0 mg/kg sugammadex, administered at T1 3-10% after continuous infusion of rocuronium intervention 2: Single bolus dose 0.6 mg/kg rocuronium and continuous infusion rocuronium intervention 3: Sevoflurane IV administered for induction and maintenance of anesthesia, based on randomization. intervention 4: Propofol IV administered for induction and maintenance of anesthesia, based on randomization.

Protocol documents:
Clinical trial NCT00254202
Conditions: Schizophrenia
Keywords: Schizophrenia Atypical antipsychotic Psychosis
Sponsor: Vanda Pharmaceuticals
Start date: 2005-11-18; Completion date: 2007-03-21
Enrollment: 593 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of iloperidone compared to placebo and an active comparator in the treatment of patients with schizophrenia in acute exacerbation.

Detailed description:
Schizophrenia is a severe mental illness affecting an estimated 1% of the world's population. Patients with schizophrenia suffer from productive symptoms (e.g., hallucinations and delusions), and deficit symptoms (e.g., a reduction or absence of normal behaviors or emotions). Other symptoms include a reduced ability to recall and learn new information.

Iloperidone is being development as a treatment for symptoms of schizophrenia. This trial will test the safety and efficacy of iloperidone in patients with an acute exacerbation of the disease.

Arms: arm 1: Oral iloperidone arm 2: Oral ziprasidone arm 3: Oral placebo
Interventions: intervention 1: Iloperidone intervention 2: Ziprasidone intervention 3: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00145470
Conditions: Bipolar Disorder
Sponsor: Organon and Co
Start date: 2005-06-02; Completion date: 2007-03-22
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 12-week study that will test the safety and efficacy of asenapine when used in addition to lithium or valproate for subjects with acute manic or mixed episodes of Bipolar I Disorder.

Detailed description:

Arms: arm 1: Participants received asenapine as a fast-dissolving sublingual (SL) tablet, given twice daily (BID). On Day 1, participants received asenapine 5 mg, BID. On Days 2 to 84, asenapine was dosed flexibly: BID at either 5 or 10 mg. Asenapine doses were up- or down-titrated based on efficacy, safety, and tolerability. arm 2: Participants received placebo on Days 1-84 as a fast-dissolving SL tablet, BID.
Interventions: intervention 1: Asenapine intervention 2: Placebo
Intervention descriptions: intervention 1: Asenapine fast dissolving SL tablets 5 and 10 mg; starting dose 5 mg BID on Day 1; 5-10 mg BID after Day 1. intervention 2: Placebo fast dissolving SL tablets, BID

Protocol documents:
Clinical trial NCT00432679
Conditions: Diabetes Mellitus, Type 2
Keywords: rosiglitazone Avandia type 2 diabetes mellitus diabetes
Sponsor: GlaxoSmithKline
Start date: 2006-05-24; Completion date: 2007-03-28
Enrollment: 149 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study was designed to compare the efficacy and safety of BRL49653C versus placebo with concomitant use of sulfonyl urea (SU).

Detailed description:

Arms: arm 1: study drug
Interventions: intervention 1: Rosiglitazone (BRL49653C)
Intervention descriptions: intervention 1: study drug

Protocol documents:
Clinical trial NCT02761642
Conditions: Anemia
Sponsor: Hoffmann-La Roche
Start date: 2004-02-29; Completion date: 2007-03-31
Enrollment: 200 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate the efficacy and safety of subcutaneous (SC) epoetin beta in anemic participants with breast cancer undergoing chemotherapy.

Detailed description:

Arms: arm 1: Anemic breast cancer participants will receive epoetin beta treatment for 12 weeks.
Interventions: intervention 1: Epoetin Beta
Intervention descriptions: intervention 1: All participants will receive epoetin beta at a dose of 30000 International Units (IU) as SC injection once every week for a total of 12 weeks. Adjustments in the dose will be implemented based on the participant's blood hemoglobin levels.

Protocol documents:
Clinical trial NCT00095498
Conditions: Rheumatoid Arthritis
Keywords: arthritis joint pain Methotrexate
Sponsor: Amgen
Start date: 2004-08-11; Completion date: 2007-04-01
Enrollment: 227 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the efficacy, safety, and tolerability of denosumab (AMG 162) in the treatment of Rheumatoid Arthritis (RA).

Detailed description:

Arms: arm 1: Participants received 180 mg denosumab by subcutaneous injection on Day 1 and at Month 6. arm 2: Participants received 60 mg denosumab by subcutaneous injection on Day 1 and at Month 6. arm 3: Participants received placebo subcutaneous injections on Day 1 and at Month 6.
Interventions: intervention 1: placebo intervention 2: denosumab
Intervention descriptions: intervention 1: placebo subcutaneous injection intervention 2: For subcutaneous injection

Protocol documents:
Clinical trial NCT00112359
Conditions: Cystic Fibrosis
Keywords: Cystic Fibrosis Pseudomonas aeruginosa Pulmonary Cystic Fibrosis
Sponsor: Gilead Sciences
Start date: 2005-05-01; Completion date: 2007-04-01
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the safety and efficacy of a 28-day course of aztreonam for inhalation solution (AZLI) in patients with cystic fibrosis (CF) and lung infection due to Pseudomonas aeruginosa (PA).

Detailed description:
CF patients often have lung infections that occur repeatedly or worsen over time. The lung infections are often caused by a bacteria called Pseudomonas aeruginosa (PA). Treatment with antibiotics can stop or slow down the growth of the bacteria. The antibiotics may be given by mouth, intravenously (IV), or by inhalation as a mist. The purpose of this study was to evaluate the safety and efficacy of AZLI, an investigational formulation of the antibiotic aztreonam and administered TID using the PARI eFlow® electronic nebulizer, in CF patients with PA.

In this study, participant eligibility was assessed at a screening visit 7 to 14 days prior to the baseline visit (Day 0). Those participants who continued to meet eligibility criteria at Day 0 were randomized and began a 28-day course of blinded study treatment (AZLI TID or placebo TID). Participants returned for clinic visits at Day 14, an end of treatment visit at Day 28, and a follow-up visit 14 days after the last dose of study drug (Day 42).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: AZLI 75 mg three times a day (TID) intervention 2: Placebo three times a day (TID)
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00159783
Conditions: Bipolar Disorder
Sponsor: Organon and Co
Start date: 2005-07-01; Completion date: 2007-04-01
Enrollment: 218 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Bipolar disorder is characterized by mood swings that range from from high (manic) to low (depressed) states. Sometimes, symptoms of both depression and mania are present (mixed episodes). Asenapine is an investigational medication for the treatment of manic or mixed episodes of bipolar disorder. Patients who completed study A7501006 (a 9 week extension study) could continue with the same treatment that they had been receiving: asenapine or olanzapine (a medication that is already approved for the treatment of bipolar mania) in a 40 -week continuation study.

Detailed description:

Arms: arm 1: Asenapine 5-10 mg twice daily for 40 weeks arm 2: Olanzapine 5-20 mg once daily for 40 weeks
Interventions: intervention 1: asenapine intervention 2: Olanzapine
Intervention descriptions: intervention 1: Asenapine, 40 weeks intervention 2: Olanzapine, 40 weeks

Protocol documents:
Clinical trial NCT00189306
Conditions: Superficial Basal Cell Carcinoma
Keywords: Superficial Basal Cell Carcinoma Aldara
Sponsor: Graceway Pharmaceuticals, LLC
Start date: 2001-03-01; Completion date: 2007-04-01
Enrollment: 169 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An open-label study to evaluate the safety and the ability of Imiquimod 5% cream, applied topically, to clear superficial basal cell carcinoma and to keep it clear for 5 years of follow-up.

Detailed description:
Evaluate the long-term sustained clearance rate, defined as the proportion of those subjects clinically clear of basal cell carcinoma (BCC) at the treated superficial BCC (sBCC) target tumor site at the 12-week posttreatment visit who remain clear during a 5 year follow-up period.

Arms: arm 1: Aldara (imiquimod) cream 5% applied 7 times per week for 6 weeks
Interventions: intervention 1: Imiquimod 5% cream
Intervention descriptions: intervention 1: Aldara (imiquimod) 5% cream - 250 mg / packet - once daily 7 days per week for 6 weeks

Protocol documents:
Clinical trial NCT00224133
Conditions: Benign Prostatic Hyperplasia
Keywords: benign prostatic hyperplasia, alpha blocker
Sponsor: Watson Pharmaceuticals
Start date: 2005-09-01; Completion date: 2007-04-01
Enrollment: 661 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
A new drug for benign prostatic hyperplasia is used for 9 months to determine its long-term safety.

Detailed description:
This will be a multi-center, open-label 40 week investigation in up to 1,200 men with signs and symptoms of benign prostatic hyperplasia. The following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the International Prostate Symptom Score, maximum urine flow rate, adverse events, concomitant medications, and compliance.

All subjects had previously participated in a 12-week double-blind placebo controlled trial (NCT000224107 or NCT000224120)

Arms: arm 1: Silodosin 8 mg per day with food
Interventions: intervention 1: Silodosin
Intervention descriptions: intervention 1: 8 mg daily

Protocol documents:
Clinical trial NCT00277446
Conditions: Asthma
Keywords: Asthma Soy isoflavones Eosinophils Exhaled nitric oxide
Sponsor: Northwestern University
Start date: 2006-01-01; Completion date: 2007-04-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
An epidemiologic study of patients with asthma has shown that increased intake of soy isoflavones correlates with less severe asthma. In experimental animals, treatment with the soy isoflavone genistein reduces airways inflammation and hyper-responsiveness. In vitro studies performed by us have shows that genistein reduces release of inflammatory compounds by human blood eosinophils. The purpose of this pilot study is to determine whether dietary supplementation with soy isoflavones has effects in patients with asthma. 20 patients with asthma will supplement their diet with a soy isoflavone capsule for 4 weeks. Before and after the supplementation period, we will measure lung function, exhaled nitric oxide (a marker for airway inflammation), collect exhaled breath condensate to measure levels of inflammatory mediators in the airways, and isolate peripheral blood eosinophils to assess the impact of soy isoflavones on their function. We hypothesize that dietary supplementation with soy isoflavones will reduce exhaled nitric oxide level, reduce the inflammatory mediators in the exhaled breath condensate, and reduce the ability of eosinophils to release inflammatory molecules. Identifying if these hypothesized effects of soy isoflavones exist in asthma will provide a justification for further clinical studies.

Detailed description:
This is a prospective pilot study to be conducted in 20 subjects with asthma. The participant will undergo the following procedures:

1. Completion of a questionnaire that asks for information about asthma including symptoms, medications, and ability to participate in activities.
2. Measurement of exhaled nitric oxide (NO) in which subjects will breathe slowly into a tube. This test takes about 5 minutes.
3. Collection of the air exhaled from the lungs and condensing it into a liquid form. This is called an exhaled breath condensate. This procedure involves breathing slowing into a tube for a period of 15 minutes. The measurements determined by this method are exclusively for research purposes and not used in routine clinical settings.
4. Measurement of lung function with a spirometer. This involves breathing in and out forcefully through a mouthpiece.
5. Collection of 60 ml (4 tablespoons) of blood to measure genistein (the major component of the soy isoflavone) levels and eosinophil function. These measurements are also for research purposes and not routinely used clinically.

Each of the above measurements will be made before and after the 4 week period of dietary supplementation with soy isoflavones.

Interventions: intervention 1: Soy isoflavones
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00280917
Conditions: Rheumatoid Arthritis
Keywords: Rheumatoid Arthritis RA
Sponsor: Can-Fite BioPharma
Start date: 2006-06-01; Completion date: 2007-04-01
Enrollment: 254 participants; Allocation: NA; Intervention model: PARALLEL

Brief summary:
This trial will test the hypothesis that the addition of CF101, a novel anti-inflammatory agent, will improve the clinical condition of patients with rheumatoid arthritis who still have active joint inflammation despite taking methotrexate for at least 6 months.

Detailed description:
This will be a multi-center, randomized, double-blind, parallel-group, placebo-controlled, dose-finding study in which patients with active RA despite receiving methotrexate for at least 6 months (at unchanged doses for \>=2 months) will be randomized to the addition of either CF101 0.1 mg, CF101 1 mg, CF101 4 mg, or placebo given orally q12h for 12 weeks. Screening examinations will occur within 1 month prior to dosing. Washout of other disease-modifying antirheumatic drugs (DMARDs) (with the exception of hydroxychloroquine), including biological agents, will occur prior to dosing; if washout is necessary, patients must re-qualify for inclusion following the washout. Doses of nonsteroidal anti-inflammatory drugs (NSAIDS) and corticosteroids must be stable for \>=1 month prior to dosing and remain so during protocol participation. Disease activity will be assessed using swollen and tender joint counts, duration of morning stiffness, physician and patient global assessments (by visual analog scale, VAS), patient reported pain (by VAS), a Health Assessment Questionnaire (HAQ) Disability Index (DI), Westergren erythrocyte sedimentation rate (ESR, Screening, Weeks 0 and12), and C-reactive protein (CRP) levels. Assessments will take place at Screening, Baseline (Week 0), and at Weeks 2, 4, 8, 12, and 14.

Interventions: intervention 1: CF101
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00293033
Conditions: Pain Cancer
Keywords: Breakthrough Pain in Patients with Cancer
Sponsor: BioDelivery Sciences International
Start date: 2006-02-01; Completion date: 2007-04-01
Enrollment: 152 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to evaluate the efficacy of BEMA Fentanyl (Onsolis) at any dose in the management of breakthrough pain in cancer subjects on background opioid therapy. The standard of care for these breakthrough pain episodes is a rapid onset, short acting analgesic with minimal associated sleepiness. Oral morphine, oxycodone and hydromorphone are routinely used, but because of slow and variable oral absorption, the pain control is not the best with these products. Oral transmucosal fentanyl citrate (OTFC) has been used successfully in treating breakthrough pain episodes associated with cancer. OTFC is a lozenge of fentanyl on a stick and is administered by continuously swabbing the interior of the subject's mouth until the product is dissolved (approximately 15 to 30 minutes). The buccal route of administration avoids the delay and variability associated with oral absorption.

Detailed description:
This is a randomized, double-blind, placebo controlled, multiple cross-over study. Eligible subjects will be treated with open label BEMA fentanyl over a period of up to two weeks. Doses will be titrated upward, starting at 200 μg, until a dose is identified that produces satisfactory pain relief for at least 2 episodes. Those subjects who identify a dose of BEMA fentanyl that produces satisfactory relief of breakthrough pain episodes will enter the double-blind, placebo controlled period of the trial. They will receive 3 placebo doses and 6 BEMA fentanyl doses in a random sequence per randomization schedule.

Arms: arm 1: Placebo arm 2: BioErodible MucoAdhesive (BEMA) Fentanyl
Interventions: intervention 1: BEMA™ intervention 2: Placebo
Intervention descriptions: intervention 1: BioDelivery Sciences International, Inc. (BDSI) has developed BioErodible MucoAdhesive (BEMA) Fentanyl, an alternative product to OTFC that does not require the subject to continuously paint the inside of the mouth with the dosage form. The BDSI product is a small soluble film that is placed against the mucosal membrane inside the mouth. The mucoadhesive polymers in the film readily adhere to the mucosal membrane (within 5 seconds) when moistened. The components of the film are water soluble, so the entire dosage form dissolves within 30 minutes of application. intervention 2: None

Protocol documents:
Clinical trial NCT00315146
Conditions: Obesity Overweight With Indications for Weight Loss
Keywords: Body Composition Sarcopenia Weight loss trials Intervention studies Elderly
Sponsor: Wake Forest University Health Sciences
Start date: 2006-04-01; Completion date: 2007-04-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this pilot study is to compare two strategies intended to improve the health of overweight older adults by improving body composition. One strategy, resistance training, is designed to preserve skeletal muscle mass. The other strategy, the use of a PPAR-γ agonist, is designed to enhance the loss of fat from visceral and skeletal depots. These strategies will be used in conjunction with a hypocaloric diet and will be compared to a hypocaloric diet alone to determine if either of these strategies are superior in reducing visceral fat and preserving muscle mass.

Detailed description:
In this pilot we propose to recruit 88 older (65 - 79 yrs) men (n=48) and women (n=40) at risk for disability and with indications for weight loss according to NIH guidelines. All will be enrolled in a dietary intervention designed to generate a caloric deficit of 500 kcal/day for a 4 month period. All will receive supplemental vitamin D and calcium. These participants will be randomized into one of 4 groups:

Group 1 - Hypocaloric diet (and placebo) Group 2 - Hypocaloric diet and resistance training designed to maximize muscular power (and placebo) Group 3 - Hypocaloric diet and a PPAR- γ agonist (pioglitazone/Actos™) Group 4 - Hypocaloric diet and resistance training and pioglitazone/Actos™

The specific aims of the pilot are:

1. In both men and women, to determine whether randomization to resistance exercise is associated with an increased retention of appendicular non-bone lean mass compared to those not undergoing power training.
2. In both men and women, to determine whether randomization to the pioglitazone group is associated with an increased loss of visceral adiposity relative to randomization to the non-pioglitazone group.
3. Assess the feasibility of the recruitment, assessment and intervention strategies
4. To estimate adherence to the weight loss, exercise training, and drug interventions;
5. In this population, to determine measurement characteristics of the functional outcomes that will be considered as primary end-points of the larger study.
6. To obtain pilot data on a subset of participants to determine the feasibility, acceptability and measurement characteristics of muscle samples (biopsies) to quantify intramyocellular lipid in this study population.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Pioglitazone intervention 2: Resistance exercise training to maximize muscle power intervention 3: Hypocaloric diet intervention 4: Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents: