ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00352690
Conditions: Carcinoma, Non-Small-Cell Lung
Sponsor: Washington University School of Medicine
Start date: 2006-04-01; Completion date: 2008-06-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is intended to evaluate the role of paclitaxel poliglumex and carboplatin in the treatment of unresectable Stage III non-small cell lung cancer along with radiation therapy in a multi-institutional trial. Consolidation chemotherapy with paclitaxel poliglumex and carboplatin will follow the completion of chemoradiation.

Detailed description:

Arms: arm 1: Paclitaxel poliglumex 135 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.

Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.

Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.

Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles. arm 2: Paclitaxel poliglumex 175 mg/m2 IV on day 1 of each 21 day cycle for a total of 2 cycles.

Carboplatin AUC=5 IV over 30 minutes on day 1 of each 21 day cycle for a total of 2 cycles.

Thoracic radiation therapy starting day 1 consisting of 66 Gy delivered in 2 Gy daily fractions.

Paclitaxel poliglumex 175 mg/m2 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.

Carboplatin AUC=6 IV beginning 3-5 weeks after completion of radiation therapy on day 1 every 21 days for a total of 2 cycles.
Interventions: intervention 1: Paclitaxel poliglumex intervention 2: Carboplatin intervention 3: External beam radiation therapy
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00360269
Conditions: Marijuana Abuse Attention Deficit Disorder With Hyperactivity
Sponsor: Medical University of South Carolina
Start date: 2005-11-01; Completion date: 2008-06-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to determine if atomoxetine treatment combined with motivational enhancement therapy is effective in reducing marijuana use in adult individuals with attention-deficit hyperactivity disorder and marijuana dependence.

Detailed description:
The purpose of this study is to determine whether the medication atomoxetine, or Strattera, plus 3 sessions of counseling can help people to reduce the symptoms of ADHD and to help cut back on their marijuana use. Participation in the study is approximately 12 weeks of medication treatment and doctor's visits once a week. The first 2 visits consist of evaluations to determine if you qualify to participate. These visits are approximately 2-3 hours long and will include questions about your past and present substance use, psychiatric history, a routine physical exam, bloodwork, and paper and pencil questionnaires about your marijuana use. Once you are enrolled in the study, visits are typically 30 minutes long, once a week. The one-on-one counseling sessions regarding marijuana use are 1 hour long and you will have 3 sessions throughout the study. If you qualify for this study, you will receive either atomoxetine, or a placebo (sugar pill). Study participants will have a 50% chance of receiving atomoxetine. Atomoxetine is a non-stimulant, commonly used to treat ADHD.

Arms: arm 1: Atomoxetine plus Motivational Enhancement Therapy arm 2: Placebo plus Motivational Enhancement Therapy
Interventions: intervention 1: Atomoxetine intervention 2: Motivational enhancement therapy intervention 3: Placebo
Intervention descriptions: intervention 1: 25 to 100 mg daily intervention 2: Three sessions intervention 3: 25 to 100 mg daily

Protocol documents:
Clinical trial NCT00360490
Conditions: Menorrhagia
Keywords: Idiopathic Menorrhagia
Sponsor: Bayer
Start date: 2006-07-01; Completion date: 2008-06-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the levonorgestrel-releasing intrauterine system is effective in decreasing menstrual blood loss.

Detailed description:
Acronyms in the Adverse Event Section:

* IUCD Intrauterine Contraceptive Device
* MedDRA Medical Dictionary for Regulatory Activities

This study has previously been posted by Berlex, Inc. and Schering AG, Germany. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc., Schering AG Germany has been renamed to Bayer HealthCare AG, Germany.

Arms: arm 1: Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. arm 2: Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.
Interventions: intervention 1: Levonorgestrel IUS (Mirena, BAY86-5028) intervention 2: Medroxyprogesterone acetate
Intervention descriptions: intervention 1: Initial release rate of 20µg Levonorgestrel IUS (Mirena, BAY86-5028) per day for 6 cycles. intervention 2: Medroxyprogesterone acetate (MPA, Provera), oral, 10mg per tablet on 10 consecutive days of each cycle for 6 cycles.

Protocol documents:
Clinical trial NCT00362466
Conditions: Leukemia
Keywords: Leukemia (chronic myeloid leukemia - chronic phase)
Sponsor: Bristol-Myers Squibb
Start date: 2007-04-01; Completion date: 2008-06-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this clinical research study is to compare the rate of complete cytogenetic response of dasatinib to imatinib therapy at 6 months after randomization in chronic phase CML patients. The safety of this treatment will also be studied.

Detailed description:

Arms: arm 1: 50-180 mg once daily (QD) arm 2: 200-800 mg QD
Interventions: intervention 1: Dasatinib intervention 2: Imatinib
Intervention descriptions: intervention 1: Tablets, Oral, Once daily, 5-7 years intervention 2: Tablets, Oral, Once daily, 5-7 years

Protocol documents:
Clinical trial NCT00372385
Conditions: Chronic Hepatitis C
Sponsor: Vertex Pharmaceuticals Incorporated
Start date: 2006-08-01; Completion date: 2008-06-01
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Compare the effectiveness of telaprevir (VX-950) in combination with Pegylated Interferon Alfa 2a (Peg-IFN-alfa-2a) with and without Ribavirin (RBV) in reducing plasma hepatitis C virus (HCV) ribonucleic acid (RNA) levels

Detailed description:

Arms: arm 1: Placebo (PBO) matched to telaprevir tablet orally thrice daily for 12 weeks in combination with pegylated interferon alfa 2a (Peg-IFN-alfa-2a) 180 microgram per week (mcg/week) subcutaneous injection and ribavirin (RBV) orally twice daily at a dose of 1000 milligram per day (mg/day) for subjects weighing less than (\<) 75 kilogram (kg) and 1200 mg/day for subjects weighing greater than or equal to (\>=) 75 kg, for 48 weeks. arm 2: Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet orally thrice daily for 12 weeks in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 24 weeks. arm 3: Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection and RBV tablet orally twice daily at a dose of 1000 mg/day for subjects weighing \<75 kg and 1200 mg/day for subjects weighing \>=75 kg, for 12 weeks. arm 4: Single loading dose of telaprevir 1250 mg tablet orally on Day 1 followed by 750 mg telaprevir tablet thrice daily in combination with Peg-IFN-alfa-2a 180 mcg/week subcutaneous injection, for 12 weeks.
Interventions: intervention 1: Ribavirin intervention 2: Pegylated Interferon Alfa 2a intervention 3: Placebo intervention 4: Telaprevir
Intervention descriptions: intervention 1: tablet intervention 2: Solution for injection intervention 3: tablet intervention 4: tablet

Protocol documents:
Clinical trial NCT00378378
Conditions: Nasal Polyps
Sponsor: Organon and Co
Start date: 2006-07-01; Completion date: 2008-06-01
Enrollment: 127 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study.

Detailed description:

Arms: arm 1: Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
Interventions: intervention 1: Mometasone Furoate Nasal Spray (MFNS) intervention 2: Placebo nasal spray
Intervention descriptions: intervention 1: 100 mcg nasal spray intervention 2: One spray of placebo nasal spray in each nostril once daily for 4 months.

Protocol documents:
Clinical trial NCT00391898
Conditions: Parkinson's Disease
Keywords: Parkinson's disease, adults, levodopa/carbidopa/entacapone, wearing-off, activities of daily living
Sponsor: Novartis
Start date: 2006-10-01; Completion date: 2008-06-01
Enrollment: 95 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluated the efficacy of levodopa/carbidopa/entacapone vs levodopa/carbidopa in patients with Parkinson's disease and early wearing-off with levodopa

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Levodopa/carbidopa/entacapone intervention 2: Levodopa/carbidopa
Intervention descriptions: intervention 1: Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa/entacapone was available in 2 oral dosage forms: 100/25/200 or 150/37.5/200 mg encapsulated tablets. intervention 2: Patients were instructed to take the study medication at the same hours and the same levodopa dose they were taking prior to enrollment in this study. Levodopa/carbidopa was available in 2 oral dosage forms: One or one and one-half 100/25 mg encapsulated tablets.

Protocol documents:
Clinical trial NCT00395486
Conditions: Metabolic Syndrome X
Keywords: rosuvastatin lipoprotein metabolic syndrome
Sponsor: AstraZeneca
Start date: 2006-09-01; Completion date: 2008-06-01
Enrollment: 258 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to compare the effect of rosuvastatin 10mg with atorvastatin 10mg after 6 weeks of treatment in the ratio of ApoB/ApoA1 in subjects with metabolic syndrome.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rosuvastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: 10mg intervention 2: 10mg

Protocol documents:
Clinical trial NCT00395876
Conditions: Dysfunctional Central Venous Access Catheters
Keywords: TNKase CVA CVAD Central venous access catheter CVA catheter
Sponsor: Genentech, Inc.
Start date: 2006-11-01; Completion date: 2008-06-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase III, randomized, double-blind, placebo-controlled study that was conducted at 24 centers in the United States and Canada. 100 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were randomly assigned in a 1:1 ratio to receive an initial dose of either placebo (Arm A) or tenecteplase (Arm B).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: placebo intervention 2: tenecteplase
Intervention descriptions: intervention 1: 2 mL of placebo instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of placebo). Patients weighing \< 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg). intervention 2: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC. Patients weighing ≥ 30 kg received 2-mL instillations of study drug (i.e., 2 mg of tenecteplase). Patients weighing \< 30 kg received instillations of study drug equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).

Protocol documents:
Clinical trial NCT00396318
Conditions: Dysfunctional Central Venous Access Catheters
Keywords: TNKase CVA CVAD Central venous access catheter
Sponsor: Genentech, Inc.
Start date: 2006-12-01; Completion date: 2008-06-01
Enrollment: 251 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This was a Phase III, open-label, single-arm study that was conducted at 43 centers in the United States and Canada. 251 adult and pediatric patients with dysfunctional central venous catheters (CVCs) were enrolled in the study and treated with one or two doses of tenecteplase.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: tenecteplase
Intervention descriptions: intervention 1: 2 mL of reconstituted lyophilized tenecteplase instilled into lumen of dysfunctional CVC.

Patients weighing ≥ 30 kg received 2-mL instillations of tenecteplase (i.e., 2 mg of tenecteplase). Patients weighing \< 30 kg received instillations of tenecteplase equal to 110% of the internal lumen volume of the dysfunctional CVC. This dose was rounded to the nearest 0.1 mL and should not have exceeded 2 mL (2 mg).

Protocol documents:
Clinical trial NCT00400400
Conditions: Renal Transplantation
Keywords: RenalTransplantation KidneyTransplantation MPA EC-MPS
Sponsor: Novartis Pharmaceuticals
Start date: 2006-10-01; Completion date: 2008-06-01
Enrollment: 400 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Treatment with the immunosuppressive drug mycophenolate mofetil (MMF) may result in gastrointestinal (GI) complications in some patients. This study will investigate the safety and tolerability of converting kidney transplant recipients with gastrointestinal symptoms from their current treatment of mycophenolate mofetil (MMF) to treatment with enteric-coated mycophenolate sodium (EC-MPS).

Detailed description:

Arms: arm 1: Enteric-coated mycophenolate sodium tablets taken orally twice a day (in the morning and in the evening) at a dose equimolar to the dose of mycophenolate mofetil the participant was taking prior to start of the study + Placebo to mycophenolate mofetil capsules taken orally twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study. arm 2: Mycophenolate mofetil capsules taken orally twice a day (in the morning and in the evening) at the dose the participant was taking prior to study start + Placebo to mycophenolate sodium tablets taken twice a day for 30 days. Participants remained on their standard immunosuppressive regimen of calcineurin inhibitors (CNI) (Cyclosporin A or Tacrolimus) administered with or without corticosteroids throughout the study.
Interventions: intervention 1: Enteric-coated mycophenolate sodium (EC-MPS) intervention 2: Mycophenolate mofetil intervention 3: Placebo to mycophenolate sodium intervention 4: Placebo to mycophenolate mofetil
Intervention descriptions: intervention 1: Enteric-coated mycophenolate sodium supplied as 180 mg tablets. intervention 2: Mycophenolate mofetil supplied as 250 mg capsules. intervention 3: Placebo to mycophenolate sodium matching tablets. intervention 4: Placebo to mycophenolate mofetil matching capsules.

Protocol documents:
Clinical trial NCT00400517
Conditions: Prostate Cancer
Keywords: stage III prostate cancer stage II prostate cancer adenocarcinoma of the prostate stage I prostate cancer stage IV prostate cancer
Sponsor: The Cleveland Clinic
Start date: 2003-03-01; Completion date: 2008-06-01
Enrollment: 28 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. Thalidomide may stop the growth of prostate cancer by blocking blood flow to the tumor. Giving GM-CSF and thalidomide before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.

PURPOSE: This phase II trial is studying how well giving GM-CSF together with thalidomide works in treating patients undergoing surgery for high-risk prostate cancer.

Detailed description:
OBJECTIVES:

* Evaluate the impact of neoadjuvant sargramostim (GM-CSF) and thalidomide on pathologic response (histologic P0, margin positivity, capsular penetration), prostate-specific antigen (PSA) response, and other investigational endpoints in patients with high-risk prostate cancer undergoing prostatectomy.
* Determine the safety and feasibility of GM-CSF and thalidomide.

OUTLINE: This is an open-label study.

Patients receive sargramostim (GM-CSF) subcutaneously on days 1, 3, and 5 and oral thalidomide on days 1-5 or 1-7 in weeks 1-4. Treatment repeats every 4 weeks for 2 courses in the absence of unacceptable toxicity.

Patients undergo radical prostatectomy with bilateral pelvic lymphadenectomy at week 8 or 9.

PROJECTED ACCRUAL: A total of 29 patients will be accrued for this study.

Arms: arm 1: taught to administer an injection of GM-CSF under your skin (subcutaneous injection) and will administer this medicine to yourself every Monday, Wednesday and Friday for 4 weeks at time. Thalidomide will be taken orally (by mouth) every evening at bed time. You will continue these injections 3 times a week and the daily oral medicine for up to 2 months if the therapy appears to be helping your disease.
Interventions: intervention 1: sargramostim intervention 2: thalidomide intervention 3: conventional surgery intervention 4: neoadjuvant therapy
Intervention descriptions: intervention 1: administered subcutaneously, generally well tolerated doses range from 50-500 ug/m2/day intervention 2: doses up to 400 mg/day intervention 3: SOC care surgery intervention 4: post radical prostatectomy

Protocol documents:
Clinical trial NCT00402727
Conditions: Abscess Wound Infection Diabetic Foot Ulcer
Sponsor: Bayer
Start date: 2006-09-01; Completion date: 2008-06-01
Enrollment: 813 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Patients, who are considered suitable by their physicians to take part in this research, will have a physical examination (including an Electrocardiogram (ECG)), blood and urine samples taken, as well as a sample of the secretions or tissue around their infection site. In addition, the site of the infection will be photographed. The patients will be randomly assigned one of the treatments: intravenous (IV)/per oral (PO) moxifloxacin (drug under evaluation) or IV piperacillin/tazobactam followed by PO amoxicillin/clavulanic acid (i.e., one of the reference treatments for this kind of infection). The maximum treatment duration will be 21 days, and the minimum will be 7 days. During the hospitalization, the patients will have a physical examination every day. On Day 3-5 during therapy as well as at the end of treatment, the patients will have repeated examinations. These tests and evaluations will be repeated 14 to 28 days after the end of treatment. During this visit, blood and urine samples will be taken only if judged necessary by the physicians.

Detailed description:

Arms: arm 1: Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory. arm 2: Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.
Interventions: intervention 1: Moxifloxacin (Avelox, BAY12-8039) intervention 2: Piperacillin/Tazobactam & Amoxicillin/Clavulanic acid
Intervention descriptions: intervention 1: Moxifloxacin (Avelox, BAY 12-8039) 400 mg intravenous (IV) once daily followed by Moxifloxacin 400 mg oral tablets once daily for a minimum of 7 days and a maximum of 21 days. Oral phase was not always mandatory. intervention 2: Piperacillin/Tacobactam 4.0/0.5 g (PIP/TAZ) administered intravenous three times daily followed by Amoxicillin/Clavulanic acid (AMC) oral tablets 875/125 mg twice daily for a minimum of 7 days and a maximum of 21 days. Oral phase not always mandatory.

Protocol documents:
Clinical trial NCT00412867
Conditions: Stroke
Keywords: Cerebral Infarction acute ischemic stroke Brain ischemia
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2006-12-01; Completion date: 2008-06-01
Enrollment: 58 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to confirm the efficacy and safety of intravenously administered alteplase in patients with acute ischemic stroke based on the rate of recanalization assessed by magnetic resonance angiography (MRA), the rate of patients with a modified Rankin Scale (mRS) score of 0-1, and the incidence of symptomatic intracranial hemorrhage (sICH), in comparison with the data reported in the current literature.

Detailed description:

Arms: arm 1: 0.6mg/kg intravenous alteplase with 10% being administered as a bolus followed by continuous infusion of the remainder over 1 hour
Interventions: intervention 1: Alteplase
Intervention descriptions: intervention 1: 0.6 mg/kg of Alteplase is intravenously administered

Protocol documents:
Clinical trial NCT00419757
Conditions: Asthma
Keywords: Moderate asthma Severe asthma
Sponsor: AstraZeneca
Start date: 2007-01-01; Completion date: 2008-06-01
Enrollment: 558 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness and safety of SYMBICORT® pMDI (a medication approved by the Food and Drug Administration(FDA)) in the Hispanic population.

Detailed description:

Arms: arm 1: SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily arm 2: budesonide HFA pMDI 160 μg x 2 actuations twice daily
Interventions: intervention 1: Budesonide/formoterol (SYMBICORT) pMDI intervention 2: Budesonide HFA pMDI
Intervention descriptions: intervention 1: SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily intervention 2: Budesonide Hydrofluoroalkane (HFA) pressurised metered dose inhaler (pMDI) 160 μg x 2 actuations twice daily

Protocol documents: