ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00325819
Conditions: Fever
Keywords: Acetaminophen Vaccination Immunization
Sponsor: Kaiser Permanente
Start date: 2006-05-01; Completion date: 2009-09-01
Enrollment: 374 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to see whether giving acetaminophen (the medicine in Tylenol) for routine infant vaccinations is helpful in preventing fever or other symptoms.

Detailed description:
Post-vaccination fever occurs in up to 40% of infants receiving routinely recommended childhood vaccinations. Although serious events are rare, post-vaccination fever causes discomfort for the child, can lead to medical utilization, can rarely result in febrile seizure, and can cause a working parent to miss time from their job to care for a febrile infant who cannot attend day care. The benefits of acetaminophen prophylaxis for infants receiving current vaccinations, in terms of reduction of discomfort for the child, improvement of quality-of-life indicators for the parent, or reduction of medical utilization, have not been measured. This randomized, blinded, placebo-controlled trial will assess the efficacy of prophylaxis with acetaminophen in prevention of fever following routine childhood immunizations.

Arms: arm 1: Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. arm 2: Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.
Interventions: intervention 1: Acetaminophen intervention 2: placebo
Intervention descriptions: intervention 1: Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations. intervention 2: Children were randomized 1:1 to receive up to five doses of acetaminophen (10-15mg per kg) or placebo following routine vaccinations.

Protocol documents:
Clinical trial NCT00347009
Conditions: Hepatitis B, Chronic Cirrhosis Fibrosis Chronic Hepatitis B
Keywords: Cirrhosis Advanced Fibrosis Chronic Hepatitis B Adefovir Dipivoxil
Sponsor: GlaxoSmithKline
Start date: 2005-05-01; Completion date: 2009-09-01
Enrollment: 155 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This 36-month open-label study of adefovir dipivoxil investigates the clinical benefits of the therapy in chronic hepatitis B patients with advanced fibrosis or cirrhosis confirmed with biopsy. Primary endpoint is histological improvement defined as a decrease of Ishak Fibrosis Score by one point or more from baseline at Month 36 of adefovir dipivoxil treatment. Approximately 150 patients will be recruited in study centres in the Asia Pacific area. The patients are offered 36 months of open label adefovir dipivoxil treatment, with assessments every three months, after which there is a 6-month post study treatment follow-up prior to study completion. After the 36 months of study treatment, it is likely that the patient will benefit from continued treatment with adefovir dipivoxil. If this is the case in the investigators clinical judgement, the investigator should ensure that a routine prescription is available in a timely manner, and that no unnecessary interruption in treatment occurs.

Detailed description:

Arms: arm 1: 10mg once daily in patients with CHB related advanced fibrosis/cirrhosis.
Interventions: intervention 1: adefovir dipivoxil
Intervention descriptions: intervention 1: 10mg once daily

Protocol documents:
Clinical trial NCT00386360
Conditions: Osteopenia
Sponsor: Warner Chilcott
Start date: 2006-04-01; Completion date: 2009-09-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the protocol is to evaluate the sensitivity of 3D-pQCT (3D-Peripheral Quantitative Computed Tomography) technology to detect minute changes in bone microarchitecture.

Detailed description:
The 3D-pQCT equipment allows the evaluation of changes occurring within the bone at "microarchitecture" level, without the need for invasive bone biopsies. The primary objective is to evaluate the sensitivity of the technology to detect a difference between those treated with risedronate 35mg OAW (once a week) or placebo. Early phase postmenopausal women with osteopenia have been chosen because they have a more rapid and higher level of bone loss during the first few years of the menopause.

Arms: arm 1: Placebo dose arm 2: 35 mg risedronate, orally, once weekly
Interventions: intervention 1: Placebo comparator intervention 2: risedronate
Intervention descriptions: intervention 1: oral weekly for one year intervention 2: 35 mg risedronate, once a week for one year

Protocol documents:
Clinical trial NCT00394095
Conditions: Bipolar Disorder Weight Gain
Keywords: Bipolar Disorder Weight Gain
Sponsor: University of Cincinnati
Start date: 2006-12-01; Completion date: 2009-09-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The primary objective of this study is to examine the efficacy of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder. The secondary objective is to examine the tolerability of topiramate in combination with olanzapine for the prevention of weight gain in youth with bipolar disorder.

Detailed description:
After consent and screening, patients will be initiated on 5mg or 10mg per day of olanzapine. Olanzapine doses will be titrated to 10-20 mg of olanzapine over one week, to a maximum of 20mg by day 21. Patients will also receive either topiramate (25mg bid titrated over 18 days to 150 mg bid. with flexibility to titrate to 200mg bid) or matched placebo. Topiramate will be initiated at a dose of 25 mg bid and will be increased by 25 mg bid every three days as tolerated. Patients will be evaluated by a blinded (to treatment status and adverse events) rater.

Arms: arm 1: Patients' initial dose of topiramate 25mg bid, which was titrated over 18 days to 150 mg bid (with flexibility to titrate to 200mg bid) as tolerated. arm 2: Sugar pill
Interventions: intervention 1: Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: Oral topiramate 300-400mg/day for 12 weeks intervention 2: Matched placebo to Experimental arm

Protocol documents:
Clinical trial NCT00400205
Conditions: Squamous Cell Carcinoma Oral Cancer
Keywords: Squamous Cell Carcinoma of the Oral Cavity
Sponsor: Emory University
Start date: 2006-08-01; Completion date: 2009-09-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum (cisplatin) and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.

Detailed description:
This is a Phase II study designed to test the efficacy of chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil in patients with squamous cell carcinoma of the oral cavity to determine what effects these agents may have on cancer cells.

Approximately 60 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute in Atlanta, Georgia.

Arms: arm 1: Participants with squamous cell carcinoma receiving chemotherapy with docetaxel, cisplatinum, and 5-fluorouracil.
Interventions: intervention 1: Docetaxel intervention 2: Cisplatin intervention 3: 5-fluorouracil
Intervention descriptions: intervention 1: Docetaxel 75 mg/m2, intravenous infusion over 1 hour, mixed with normal saline per institutional standard, day 1 and then every 3 weeks. intervention 2: Cisplatin 100 mg/m2, intravenous infusion over 30 minutes to 3 hours, day 1 and then every 3 weeks. intervention 3: 5-fluorouracil 1000 mg/m2/day, 24 hour continuous infusion over 4 days, every 3 weeks.

Protocol documents:
Clinical trial NCT00408928
Conditions: Graft-versus-Host Disease
Keywords: Graft-versus-Host Disease bortezomib
Sponsor: Sidney Kimmel Cancer Center at Thomas Jefferson University
Start date: 2005-11-01; Completion date: 2009-09-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to test the safety and effectiveness of VELCADE® in the treatment of acute graft-versus-host disease (GVHD) that has not responded to steroids or has worsened when the steroid dose was decreased. VELCADE® is a drug that inhibits certain immune reactions that happen when lymphocytes encounter foreign substances. We are doing this research to determine if VELCADE® may be useful in treating GVHD.

Detailed description:
Graft-versus-host disease (GVHD) is a serious complication after bone marrow transplantation from another donor. GVHD is caused by certain cells called lymphocytes. Normally these cells make immune reactions that help protect the body from foreign substances that cause infection. Here, these cells attack the normal tissues of the body as if they were foreign substances. This interferes with the normal function of vital organs and results in their damage. In GVHD these cells attack the skin, liver and bowel. GVHD also increases the chances of infection.

VELCADE® is a drug that inhibits certain immune reactions that happen when lymphocytes encounter foreign substances. We are doing this research to determine if VELCADE® may be useful in treating GVHD.

VELCADE® is approved by the Food and Drug Administration (FDA) for the treatment of multiple myeloma in patients who have received at least two prior therapies and have demonstrated disease progression on their last therapy. Its effectiveness is also being tested in other cancers. The dose of the drug being used in this research study is the same as what is used for the treatment of multiple myeloma. It has not been approved by the FDA for use in GVHD. Therefore, using VELCADE® for GVHD is experimental in this research study.

Arms: arm 1: To determine if bortezomib (VELCADE®) will successfully inhibit T-cell responses in clinically acute graft-versus-host disease (GVHD) after allogeneic hematopoietic stem cell transplantation (HSCT).
Interventions: intervention 1: Bortezomib
Intervention descriptions: intervention 1: Bortezomib at 1.3 mg/m2/dose given twice weekly for two weeks followed by a 10-day rest period. If patients have a complete response, they will receive additional cycles of bortezomib.

Protocol documents:
Clinical trial NCT00413400
Conditions: Metabolic Syndrome
Keywords: Inflammation Visceral adiposity TNF Adiponectin glucose tolerance endothelial function metabolic syndrome
Sponsor: Massachusetts General Hospital
Start date: 2006-12-01; Completion date: 2009-09-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate whether etanercept will result in improved inflammatory indices, glucose tolerance and endothelial function in patients with the metabolic syndrome.

Detailed description:
Metabolic syndrome is an increasingly prevalent disorder associated with elevated risks of type II DM (diabetes mellitus) and cardiovascular morbidity and mortality. A subclinical inflammatory state is thought to contribute to the pathophysiology of metabolic syndrome, insulin resistance, and coronary artery disease (CAD). Tumor Necrosis Factor (TNF) -alpha is an inflammatory cytokine that is increased in a spectrum of inflammatory diseases as well as in insulin resistance. TNF-alpha antagonists are clinically effective in the inflammation of arthritides, and have recently been shown by our group to decrease inflammatory cardiovascular risk markers in metabolic syndrome. Data suggests that adiponectin, a recently discovered adipocytokine that may protect against the development of insulin resistance and atherosclerosis, may be downregulated by TNF-alpha. In addition, population based studies have shown that those with the highest levels of TNF-alpha have an increased relative risk of cardiovascular morbidity while rheumatoid arthritis patients treated with TNF-alpha blockade appear protected from cardiovascular disease. We will perform a 6-month study in which we will administer etanercept, a TNF-alpha receptor fusion protein, to subjects with metabolic syndrome to investigate its effect on surrogate markers of cardiovascular disease, including inflammatory markers, adiponectin and glucose tolerance and endothelial function. The results of the proposed study will have broad implications regarding the physiological role of TNF-alpha on the inflammatory cascade, cardiovascular indices and endothelial function.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Etanercept intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg one syringe sc 2X per week for three months followed by 50 mg one syringe sc 1X per week for three months intervention 2: 50 mg one syringe sc 2x per week for three months followed by 50 mg one syringe sc 1X per week for three months

Protocol documents:
Clinical trial NCT00419094
Conditions: Epilepsy
Keywords: Keppra XR conversion to monotherapy partial seizures
Sponsor: UCB Pharma
Start date: 2007-08-01; Completion date: 2009-09-01
Enrollment: 228 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess the efficacy of two doses of Keppra XR compared with a historical control as the placebo, in the monotherapy treatment of partial onset seizures.

Detailed description:

Arms: arm 1: 1000 mg/day once daily for 18 weeks (administered as two levetiracetam XR tablets and two placebo tablets once daily) arm 2: 2000 mg/day once daily for 18 weeks (administered as four levetiracetam XR tablets once daily)
Interventions: intervention 1: Keppra XR intervention 2: Keppra XR
Intervention descriptions: intervention 1: Administered as two 500 mg tablets (1000 mg) and two placebo tablets once daily for 18 weeks intervention 2: Administered as four 500 mg tablets (2000 mg) once daily for 18 weeks

Protocol documents:
Clinical trial NCT00420511
Conditions: Type 2 Diabetes Mellitus
Keywords: Type 2 diabetes beta-cell function sitagliptin intensive insulin therapy
Sponsor: Samuel Lunenfeld Research Institute, Mount Sinai Hospital
Start date: 2007-01-01; Completion date: 2009-09-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Type 2 diabetes mellitus (T2DM) is a chronic metabolic disorder characterized by progressive deterioration in the function of the pancreatic beta-cells, which are the cells that produce and secrete insulin (the hormone primarily responsible for the handling of glucose in the body). The investigators propose a double-blind, randomized controlled pilot study comparing the effect of sitagliptin (a novel anti-diabetic drug with beta-cell protective potential) versus placebo, on the preservation of beta-cell function over one year in patients with T2DM on metformin, the first-line agent for the treatment of T2DM (ie. the study groups will be (i) sitagliptin and metformin versus (ii) placebo and metformin). This study may demonstrate an important beta-cell protective capacity of sitagliptin.

Hypothesis: In patients with T2DM on metformin, treatment with the DPP-IV inhibitor sitagliptin will preserve pancreatic beta-cell function.

Detailed description:
Medications currently used in the treatment of T2DM have not been shown to modify the progressive decline in beta-cell function that occurs over time. Recent evidence, however, suggests that a new class of anti-diabetic medications, called dipeptidyl peptidase-IV (DPP-IV) inhibitors, may be able to protect beta cells and hence alter the natural history of T2DM. We thus wish to study the effect of sitagliptin (a DPP-IV inhibitor) on the preservation of beta-cell function in patients with T2DM randomized to either (i) sitagliptin and metformin or (ii) placebo and metformin.

Arms: arm 1: Sitagliptin 100mg once a day (od) by mouth (po) arm 2: Placebo once a day (od) by mouth (po)
Interventions: intervention 1: Sitagliptin intervention 2: Placebo intervention 3: metformin
Intervention descriptions: intervention 1: sitagliptin 100 mg once a day intervention 2: placebo once a day intervention 3: metformin 1000 mg twice a day (bid) by mouth (po)

Protocol documents:
Clinical trial NCT00428974
Conditions: Plaque Psoriasis
Keywords: Psoriasis
Sponsor: Can-Fite BioPharma
Start date: 2007-06-01; Completion date: 2009-09-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the hypothesis that CF101, which is under development to treat other immune-mediated inflammatory diseases, will provide clinical benefits in the treatment of chronic plaque psoriasis. Patients with psoriasis who qualify for the study will be treated every 12 hours (q12h) with CF101 capsules, or placebo capsules, for 12 weeks. The safety of treatment will be carefully assessed through clinical and laboratory monitoring. The effect of treatment on psoriasis will be evaluated through standard techniques of examination and measurement of the severity of skin involvement.

Detailed description:
This is a Phase 2, multicenter, randomized, double-blind, dose-ranging, placebo-controlled, study in adult males and females, ages 18 to 70 years, inclusive, with a diagnosis of moderate-to-severe chronic plaque psoriasis. At the Screening Visit, patients who provide written informed consent will have screening procedures performed, including a complete medical history, medication history, physical examination, including height, weight, blood pressure, pulse rate and temperature, and clinical laboratory tests.

Eligible patients will be those who have not received systemic retinoids, corticosteroids, or immunosuppressants (e.g., methotrexate, cyclosporine) within 6 weeks prior to initiation of study; or high potency topical corticosteroids (Class I-III), keratolytics, or coal tar (other than on the scalp, palms, groin, and/or soles); and UV or Dead Sea therapy within 4 weeks prior to initiation of study treatment. Eligible patients will be sequentially assigned to 1 of 3 dosing cohorts:

Cohort 1: CF101 1 mg (15 patients) or Placebo (5 patients); Cohort 2: CF101 2 mg (15 patients) or Placebo (5 patients); Cohort 3: CF101 4 mg (15 patients) or Placebo (5 patients).

Medication will be taken orally q12h for 12 weeks. Disease activity will be assessed using the Psoriasis Area and Severity Index (PASI) and the Physician Global Assessment (PGA). Patients will return for assessments at Weeks 2, 4, 8, 12 and 14.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: CF101 1mg intervention 2: CF101 2mg intervention 3: CF101 4mg intervention 4: Placebo
Intervention descriptions: intervention 1: CF101 1 mg q12 hours for 12 weeks intervention 2: CF101 2 mg q12 hours for 12 weeks intervention 3: CF101 4 mg q12 hours for 12 weeks intervention 4: Placebo tablets q12 hours for 12 weeks

Protocol documents:
Clinical trial NCT00430495
Conditions: Rheumatoid Arthritis
Keywords: atacicept arthritis
Sponsor: EMD Serono
Start date: 2006-12-01; Completion date: 2009-09-01
Enrollment: 256 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a double-blind, placebo-controlled, parallel-arm, multicentre, prospective dose-finding trial of the safety and efficacy of atacicept in subjects with active rheumatoid arthritis who had failed a three month therapeutic trial with a tumor necrosis factor alpha (TNFa) antagonist due to lack of efficacy.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Atacicept intervention 2: Atacicept intervention 3: Atacicept intervention 4: Placebo matched to atacicept
Intervention descriptions: intervention 1: Atacicept was administered subcutaneously at a dose of 25 milligram (mg) twice a week for initial 4 weeks as loading dose, followed by 25 mg once a week for subsequent 21 weeks. intervention 2: Atacicept was administered subcutaneously at a dose of 75 mg twice a week for initial 4 weeks as loading dose, followed by 75 mg once a week for subsequent 21 weeks. intervention 3: Atacicept was administered subcutaneously at a dose of 150 mg twice a week for initial 4 weeks as loading dose, followed by 150 mg once a week for subsequent 21 weeks. intervention 4: Placebo matched to atacicept was administered subcutaneously twice a week for initial 4 weeks, followed by once a week for subsequent 21 weeks.

Protocol documents:
Clinical trial NCT00433160
Conditions: Osteoporosis
Sponsor: Eli Lilly and Company
Start date: 2007-01-01; Completion date: 2009-09-01
Enrollment: 207 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of teriparatide based on measurements of bone mineral density at lumbar spine

Detailed description:

Arms: arm 1: 20 micrograms for 104 weeks arm 2: Placebo for 52 weeks. After 52 weeks, all patients on placebo can receive 20 micrograms teriparatide for 52 weeks
Interventions: intervention 1: Teriparatide intervention 2: Placebo
Intervention descriptions: intervention 1: daily, subcutaneous intervention 2: daily, subcutaneous

Protocol documents:
Clinical trial NCT00439725
Conditions: Venous Thromboembolism
Sponsor: Bayer
Start date: 2007-02-01; Completion date: 2009-09-01
Enrollment: 1197 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multicenter, randomized, double-blind, placebo-controlled, event-driven, superiority study for efficacy. Patients with confirmed symptomatic DVT (deep vein thrombosis) or PE (pulmonary embolism) who completed 6 or 12 months of treatment with rivaroxaban or VKA (vitamin K antagonist) are eligible for this trial (Einstein-Extension study).

Detailed description:
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

The treatment period was followed by an observational period of 30 days starting the day after the last intake of study medication, regardless of the actual duration of study drug administration. Participants who did not complete the treatment period also entered the observational period. It was also possible that participants did not enter the observational period, e.g. due to withdrawal of consent or termination of study participation.

Arms: arm 1: Participants were to receive rivaroxaban 20 mg oral tablet once daily arm 2: Participants were to receive matching placebo oral tablet once daily
Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Placebo
Intervention descriptions: intervention 1: Patients randomized to rivaroxaban will receive rivaroxaban 20 mg once-daily. intervention 2: Patients allocated to placebo will receive a matching placebo tablet once daily.

Protocol documents: