ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00843193
Conditions: Asthma
Keywords: Asthma Asthma control questionnaire
Sponsor: GlaxoSmithKline
Start date: 2008-12-09; Completion date: 2010-07-25
Enrollment: 198 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Treatment, Randomised, Double Blind, Parallel Assignment, Safety/efficacy Study

Detailed description:
A Multi-Centre, Multi-country, Randomized, Double-Blind (Subject, Investigator), Placebo-Controlled, Repeat-Dose study to evaluate the Efficacy and Safety of Intravenous GSK679586 in Patients with Severe Asthma

Arms: arm 1: Subjects will receive three, once monthly intravenous administration of 10 mg/kg of GSK679586, according to randomization arm 2: Subjects will receive three, once monthly intravenous administration of saline, according to randomization
Interventions: intervention 1: INTRAVENOUS GSK679586 intervention 2: INTRAVENOUS PLACEBO intervention 3: FLUTICASONE PROPIONATE
Intervention descriptions: intervention 1: GSK679586 will be provided as a clear or colorless to pale yellow liquid with the unit dose strength of 10mg/kg and will be infused over an hour. The infusion will be delivered by a programmable infusion pump intervention 2: Clear or colorless 0.9% sodium chloride saline solution will be infused over an hour. The infusion will be delivered by a programmable infusion pump intervention 3: Subjects will be supplied fluticasone propionate at Screening, Run-in and when needed during the study. Subjects will be up-titrated to 1000 μg/day and those who were already taking greater than equal to 1000 μg/day fluticasone propionate or equivalent prior to the study will remain on their pre-study dose.

Protocol documents:
Clinical trial NCT00481767
Conditions: Human Papillomavirus (HPV) Infection
Keywords: Safety Immunogenicity Human Papillomavirus (HPV) vaccine
Sponsor: GlaxoSmithKline
Start date: 2007-10-01; Completion date: 2010-07-26
Enrollment: 676 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cervical cancer is the second most common cancer among women worldwide. Approximately 500 000 new cases are reported each year worldwide, from which 83% occur in developing countries. The incidence of cervical cancer varies depending on the region of the world. Africa has some of the highest age-standardized incidence and mortality rates in the world (Eastern Africa 42.7 and 34.6 per 100 000; Southern Africa 38.2 and 22.6 per 100 000; Western Africa 29.3 and 23.8 per 100 000; Middle Africa 28.0 and 23.0 per 100 000).

As in the majority of developing countries, organization of cervical cancer screening programs in Africa is difficult to manage, especially in rural areas. HPV prophylactic vaccination could therefore clearly and efficiently decrease the incidence of cervical cancer. The current study is designed to assess the immunogenicity and safety of GSK Biologicals' HPV-16/18 L1 AS04 vaccine in female subjects enrolled from multiple countries in Africa.

Ideally, HPV vaccination should be performed before onset of sexual activity, since studies have shown that acquisition of high-risk HPV occurs soon after sexual debut. This study will therefore be performed in subjects aged 10 to 25 years of age.

Detailed description:

Arms: arm 1: Healthy female subjects who received 3 doses of Cervarix at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group. arm 2: Healthy female subjects who received 3 doses of placebo at Months 0, 1 and 6, administered intramuscularly into the deltoid region of the non-dominant arm. For some analyses the group was stratified by age into a 10-14 years of age group and a 15-25 years of age group.
Interventions: intervention 1: Cervarix intervention 2: Placebo Al(OH)3
Intervention descriptions: intervention 1: The vaccine was administered according to a 0, 1, and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm. intervention 2: Placebo was administered according to a 0, 1 and 6-month schedule, intramuscularly into the deltoid region of the non-dominant arm.

Protocol documents:
Clinical trial NCT00724048
Conditions: Huntington Disease
Keywords: Huntington Disease
Sponsor: Teva Branded Pharmaceutical Products R&D, Inc.
Start date: 2008-10-24; Completion date: 2010-07-26
Enrollment: 227 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if ACR16 is effective and safe in the symptomatic treatment of Huntington's Disease.

Detailed description:

Arms: arm 1: Participants will receive a placebo capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), placebo capsule will be taken twice daily (BID) as 2 separate doses. arm 2: Participants will receive ACR16 10 milligrams (mg) capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 10 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 20 mg). arm 3: Participants will receive ACR16 22.5 mg capsule orally once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 22.5 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 45 mg). arm 4: Participants will receive ACR16 45 mg capsule once daily for the first 4 weeks. After 4 weeks (Weeks 5 to 12), ACR16 45 mg capsule will be taken twice daily (BID) as 2 separate doses (total dose: 90 mg).
Interventions: intervention 1: ACR16 intervention 2: Placebo
Intervention descriptions: intervention 1: ACR16 will be administered per dose and schedule specified in the arm description. intervention 2: Placebo matching to ACR16 will be administered per schedule specified in the arm description.

Protocol documents:
Clinical trial NCT01013701
Conditions: Patients With Nasal Polyps
Keywords: nasal polyps nasal steroid fluticasone furoate
Sponsor: Johns Hopkins University
Start date: 2009-11-01; Completion date: 2010-07-29
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Fluticasone furoate is being studied to determine whether treatment with a topical nasal steroid, in patients with existing nasal polyps , can not only improve symptoms but also suppress the recurrence of clinically significant nasal polyp obstruction and prevent surgical intervention.

Detailed description:

Arms: arm 1: nasal steroid arm 2: nasal spray vehicle without drug
Interventions: intervention 1: fluticasone furoate intervention 2: placebo
Intervention descriptions: intervention 1: nasal steroid spray intervention 2: nasal steroid vehicle without drug

Protocol documents:
Clinical trial NCT01015677
Conditions: Moderate to Severe Vasomotor Symptoms in Postmenopausal Women
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-12-17; Completion date: 2010-07-30
Enrollment: 99 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety, tolerability, and efficacy of MK-6913 for the treatment of moderate-to-very-severe vasomotor symptoms (hot flashes or hot flushes) in postmenopausal women. The primary study hypothesis is that one or more doses of MK-6913 will result in a significantly greater reduction from baseline, compared to placebo, in the number of moderate to very severe hot flashes after 4 weeks of treatment.

Detailed description:

Arms: arm 1: MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and Stage 2) arm 2: 17β-estradiol 1 mg tablet and matching placebo for MK-6913 75 mg capsule once daily for 4 weeks (Stage 1 and Stage 2) arm 3: Matching placebo for MK-6913 75 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 1 and State 2) arm 4: MK-6913 25 mg capsule and matching placebo for 17β-estradiol 1 mg tablet once daily for 4 weeks (Stage 2)
Interventions: intervention 1: MK-6913 intervention 2: 17-β estradiol intervention 3: Placebo to MK-6913 intervention 4: Placebo to 17-β estradiol intervention 5: MK-6913 25 mg
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None intervention 5: None

Protocol documents:
Clinical trial NCT01134549
Conditions: Hyperparathyroidism, Secondary
Sponsor: KAI Pharmaceuticals
Start date: 2010-06-09; Completion date: 2010-07-31
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to characterize the safety and tolerability of etelcalcetide in healthy young males.

Detailed description:

Arms: arm 1: Participants received a single dose of placebo intravenous injection. arm 2: Participants received a single dose of etelcalcetide intravenous injection; the starting dose was 0.5 mg.
Interventions: intervention 1: Etelcalcetide intervention 2: Placebo
Intervention descriptions: intervention 1: Administered as a single intravenous (IV) injection intervention 2: Administered as a single intravenous (IV) injection

Protocol documents:
Clinical trial NCT00414466
Conditions: Chronic Intractable Pain
Sponsor: MedtronicNeuro
Start date: 2006-12-01; Completion date: 2010-08-01
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and minimum effective dose of intraspinal gabapentin when delivered through an implanted drug infusion system.

Detailed description:

Arms: arm 1: Intraspinal Placebo delivered continuously for 29 days via an implantable infusion system arm 2: Intraspinal Gabapentin Low delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose arm 3: Intraspinal Gabapentin Medium delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose arm 4: Intraspinal Gabapentin High delivered continuously for 22 days via an implantable infusion system followed by 7 days infusion at half dose
Interventions: intervention 1: Intraspinal Gabapentin
Intervention descriptions: intervention 1: Surgical implantation of a drug infusion system with intrathecal (spinal) delivery of active drug (1 of 3 possible dose levels) or placebo (saline) for 22 days followed by 7 days of infusion at half dose level. Subjects may then continue in open-label treatment with study drug. Dosage in open-label may be adjusted to meet subject needs.

Protocol documents:
Clinical trial NCT00474045
Conditions: Diabetes Diabetes Mellitus, Type 1
Sponsor: Novo Nordisk A/S
Start date: 2007-05-01; Completion date: 2010-08-01
Enrollment: 470 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This trial is conducted in Africa, Europe, North and South America and Oceania. The aim of this trial is to compare the effect and safety on blood glucose control in pregnant women with type 1 diabetes of a modern insulin analogue (insulin detemir) and human insulin (NPH insulin) given as long-acting insulin in combination with a short-acting insulin (insulin aspart).

Detailed description:

Arms: arm 1: Individually adjusted insulin detemir injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn arm 2: Individually adjusted NPH insulin injected subcutaneously as basal insulin + individually adjusted insulin aspart injected subcutaneously as bolus insulin from randomisation (gestational week 8-12) and continued until 6 weeks after delivery. If a subject was not pregnant at randomisation, treatment was given up to a maximum of 52 weeks. For subjects who became pregnant, randomised treatment was continued until 6 weeks after delivery. Subjects who were not pregnant at 52 weeks after randomisation were withdrawn
Interventions: intervention 1: insulin detemir intervention 2: NPH insulin intervention 3: insulin aspart
Intervention descriptions: intervention 1: Treat-to-target, dose titration, s.c. (under the skin) injection intervention 2: Treat-to-target, dose titration, s.c. (under the skin) injection intervention 3: Treat-to-target, dose titration, s.c. (under the skin) injection

Protocol documents:
Clinical trial NCT00531934
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2007-10-01; Completion date: 2010-08-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This 2 arm study will evaluate the management of Tarceva-induced skin rash in patients with non-small cell lung cancer who have failed first-line chemotherapy for advanced disease. Eligible patients will be randomized to receive a)doxycycline 100mg po daily or b)no preventative treatment; all patients will receive Tarceva 150mg/kg po daily. The anticipated time on study treatment is until disease progression or intolerable toxicity, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Doxycline intervention 2: erlotinib [Tarceva]
Intervention descriptions: intervention 1: 100mg po daily intervention 2: 150mg po daily

Protocol documents:
Clinical trial NCT00058019
Conditions: Anaplastic Large Cell Lymphoma Recurrent Adult Burkitt Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Diffuse Mixed Cell Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2003-02-01; Completion date: 2010-08-01
Enrollment: 51 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well ixabepilone works in treating patients with relapsed or refractory aggressive non-Hodgkin's lymphoma. Drugs used in chemotherapy, such as ixabepilone, work in different ways to stop cancer cells from dividing so they stop growing or die.

Detailed description:
OBJECTIVES:

I. Determine the objective overall response rate of patients with relapsed or refractory aggressive non-Hodgkin's lymphoma treated with BMS-247550 (ixabepilone).

II. Determine the safety and toxicity of this drug in these patients. III. Determine the duration of response, overall survival, and time to progression in patients treated with this drug.

OUTLINE: This is a multi-center study.

Patients receive ixabepilone intravenously (IV) over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.

Patients are followed every 8 weeks until disease progression.

Arms: arm 1: Patients receive ixabepilone IV over 1 hour on days 1, 8, and 15. Courses repeat every 28 days in the absence of disease progression, unacceptable toxicity, or if the patient becomes a candidate for stem cell transplantation.
Interventions: intervention 1: ixabepilone
Intervention descriptions: intervention 1: Given IV

Protocol documents:
Clinical trial NCT00110084
Conditions: Breast Cancer
Keywords: recurrent breast cancer stage IV breast cancer
Sponsor: Mayo Clinic
Start date: 2005-08-01; Completion date: 2010-08-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as ABI-007(Nab-Paclitaxel((Nanoparticle Albumin Bound)-Paclitaxel)) and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving ABI-007 together with gemcitabine works in treating women with metastatic breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the antitumor activity of ABI-007 and gemcitabine, in terms of response rate in women with metastatic breast cancer.
* Determine the toxicity profile of this regimen, in terms of incidence and severity of observed toxic effects, in these patients.

Secondary

\* Determine the time to disease progression and survival of patients treated with this regimen.

OUTLINE: This is a multicenter study. Patients receive ABI-007 IV over 30 minutes and gemcitabine IV over 30 minutes on days 1 and 8. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for up to 5 years.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study within 20 months.

Arms: arm 1: None
Interventions: intervention 1: Gemcitabine intervention 2: Paclitaxel protein-bound particles for injectable suspension (albumin-bound)
Intervention descriptions: intervention 1: 1000 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle intervention 2: 125 mg/m2 (IV over 30 min) (days 1 and 8) on 21 day cycle

Protocol documents:
Clinical trial NCT00115778
Conditions: Hypogammaglobulinemia Lung Transplantation
Keywords: Hypogammaglobulinemia Lung Transplantation
Sponsor: Columbia University
Start date: 2005-06-01; Completion date: 2010-08-01
Enrollment: 11 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine if intravenous immunoglobulin (IVIG) can prevent bacterial infections in lung transplant patients with low serum levels of immunoglobulin.

Detailed description:
An increased risk of infection despite intensive antimicrobial prophylaxis is a well-recognized complication of lung transplantation. Recent evidence suggests that immunosuppressive therapy after solid organ transplantation may lead to humoral immunodeficiency due to hypogammaglobulinemia (HGG). In lung transplant recipients with HGG, IVIG therapy offers the potential to significantly decrease the incidence and severity of infections, thereby reducing morbidity and potentially mortality.

Comparison: The investigators are conducting a randomized clinical trial of IVIG versus placebo for lung transplant patients with severe HGG to see if IVIG decreases the number of bacterial infections in these patients.

Arms: arm 1: Study participants will receive three doses of IVIG given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of placebo over 12 weeks. arm 2: Study participants will receive three doses of 0.1% albumin solution (placebo) given four weeks apart over 12 weeks followed by a twelve-week washout and then three doses of IVIG over 12 weeks.
Interventions: intervention 1: IVIG intervention 2: Placebo
Intervention descriptions: intervention 1: 10% Caprylate/Chromatography Purified Intravenous Immunoglobulin 400 mg/kg IV every 4 weeks intervention 2: 0.1% Albumin in an equal volume to the investigational product

Protocol documents:
Clinical trial NCT00125372
Conditions: Carcinoma, Non-small-cell Lung
Keywords: tarceva targretin non-small cell lung cancer carcinoma, non-small cell lung cancer nsclc
Sponsor: Dartmouth-Hitchcock Medical Center
Start date: 2005-12-01; Completion date: 2010-08-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn the effects on lung cancer of 2 new drugs, Tarceva and Targretin, given in combination before surgical removal of the tumor. Tarceva is approved by the Food and Drug Administration (FDA) for lung cancer. Targretin is approved for the treatment of cutaneous T-cell lymphoma. This combination of drugs is experimental.

Detailed description:
Erlotinib 150mg and bexarotene 400mg/m2 will be administered orally for 7-9 days prior to thoracotomy. Plasma samples will be collected on the day before surgery and along with tissue samples on the day of the thoracotomy. Analyses will be done on the resected specimen and it will be compared to the pre-study diagnostic specimen.

Arms: arm 1: Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy.
Interventions: intervention 1: erlotinib (Tarceva) and bexarotene (Targretin)
Intervention descriptions: intervention 1: Erlotinib 150 mg and bexarotene 400 mg/m2/day will be administered orally for 7 to 9 days prior to thoracotomy

Protocol documents:
Clinical trial NCT00141778
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation cardiac surgery
Sponsor: Vanderbilt University
Start date: 2005-04-01; Completion date: 2010-08-01
Enrollment: 455 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Atrial fibrillation (AF) is the most prevalent, sustained type of irregular heartbeat and affects over 2 million Americans. Post-operative AF, which leads to significant morbidity and a prolonged hospital stay, complicates 20% to 40% of cardiopulmonary bypass (CPB) surgical procedures. While recent studies indicate that interruption of the renin-angiotensin-aldosterone system by either angiotensin-converting enzyme (ACE) inhibition or AT1 receptor antagonism decreases the incidence of AF following a heart attack or cardioversion (electric shock to the heart), its effect on the incidence of post-operative AF has not been throughly studied. Studies in both animals and humans suggest that inflammation-induced atrial remodeling plays an important role in the cause of AF. Recent studies also provide evidence that activation of the renin-angiotensin-aldosterone system induces inflammation, myocyte injury, proarrhythmic electrical remodeling, and fibrosis through aldosterone.

Detailed description:
AF is the most prevalent, sustained type of irregular heartbeat and affects over 2 million Americans. Post-operative atrial fibrillation(AF), which leads to significant morbidity and a prolonged hospital stay, complicates 20% to 40% of CPB surgical procedures. While recent studies indicate that interruption of the renin-angiotensin-aldosterone system by either angiotensin-converting enzyme(ACE) inhibition or angiotensin II subtype 1 (AT1) receptor antagonism decreases the incidence of AF following a heart attack or cardioversion (electric shock to the heart), its effect on the incidence of post-operative AF has not been throughly studied. Studies in both animals and humans suggest that inflammation-induced atrial remodeling plays an important role in the cause of AF. Recent studies also provide evidence that activation of the renin-angiotensin-aldosterone system induces inflammation, myocyte injury, proarrhythmic electrical remodeling, and fibrosis through aldosterone.

This study will evaluate the effectiveness of ACE inhibition and aldosterone receptor antagonism at decreasing inflammation and AF following cardiopulmonary bypass (CPB) surgery.

Arms: arm 1: matched placebo pills daily beginning 4-7 days before surgery and continuing through discharge arm 2: Ramipril daily (2.5mg, increased to 5mg) beginning 4 to 7 days before surgery and continuing through discharge arm 3: Spironolactone 25mg daily beginning 4 to 7 days before surgery and continuing through discharge
Interventions: intervention 1: Placebo intervention 2: Ramipril intervention 3: Spironolactone
Intervention descriptions: intervention 1: Matching placebo taken once a day intervention 2: Taken orally, once a day intervention 3: Taken orally, once a day

Protocol documents: