ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00840086
Conditions: Congenital Bleeding Disorder Haemophilia A
Sponsor: Novo Nordisk A/S
Start date: 2009-04-01; Completion date: 2011-09-01
Enrollment: 150 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This trial is conducted in Asia, Europe, and North and South America. The trial consists of a main trial and a sub-trial. The main trial investigates safety and efficacy of turoctocog alfa (recombinant factor VIII, rFVIII (N8)) in haemophilia A subjects, while the sub-trial investigates safety and efficacy of turoctocog alfa in prevention and treatment of bleeding episodes during surgical procedures.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: turoctocog alfa
Intervention descriptions: intervention 1: Subjects will receive bleeding preventive treatment (home treatment with self-injection i.v.) with turoctocog alfa at a dose of 20-40 IU/kg body weight every second day or 20-50 IU/kg body weight three times per week at the investigator's discretion.

Protocol documents:
Clinical trial NCT00849693
Conditions: Major Depressive Disorder
Sponsor: Eli Lilly and Company
Start date: 2009-03-01; Completion date: 2011-09-01
Enrollment: 463 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess whether duloxetine is superior to placebo in the treatment of children and adolescents with major depressive disorder (MDD)

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Placebo intervention 2: fluoxetine intervention 3: duloxetine intervention 4: duloxetine
Intervention descriptions: intervention 1: Capsules identical in appearance, color, taste, and smell to study drug, orally, once daily for 10 weeks (acute treatment phase) intervention 2: 20 milligram (mg) orally, once daily for 10 weeks (acute treatment phase) and 20-40 mg orally, once daily for additional 6 months (extension phase) intervention 3: 60 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase) intervention 4: 30 mg orally, once daily for 10 weeks (acute treatment phase) and 60-120 mg orally, once daily for additional 6 months (extension phase)

Protocol documents:
Clinical trial NCT00996580
Conditions: Pregnancy Prevention
Keywords: Contraception Oral contraceptives
Sponsor: Teva Women's Health
Start date: 2009-10-01; Completion date: 2011-09-01
Enrollment: 3597 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, single-treatment study. All subjects will receive 12 months of oral contraceptive therapy with DR-103. Study participants will receive physical and gynecological exams, including Pap smear. During the study, all participants will be required to complete a diary.

Detailed description:

Arms: arm 1: Four 91-day cycles of the DR-103 regimen:

* 42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by;
* 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by;
* 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by;
* 7 days of 10 mcg EE.
Interventions: intervention 1: DR-103
Intervention descriptions: intervention 1: One tablet daily.

Four 91-day cycles of the DR-103 regimen:

42 days combination therapy of 20 mcg ethinyl estradiol (EE) /150 mcg levonorgestrel (LNG) followed by; 21 days combination therapy of 25 mcg EE/150 mcg LNG followed by; 21 days combination therapy of 30 mcg EE/150 mcg LNG followed by; 7 days of 10 mcg EE.

Protocol documents:
Clinical trial NCT01217814
Conditions: Rheumatoid Arthritis
Sponsor: Sanofi
Start date: 2010-11-01; Completion date: 2011-09-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

\- To demonstrate that sarilumab (SAR153191/REGN88) on top of methotrexate (MTX) was superior in efficacy to placebo for the relief of signs and symptoms of rheumatoid arthritis (RA), in participants with active RA who had failed up to 2 tumor necrosis factor-alpha (TNF-α) antagonists.

Secondary Objectives:

* To assess the safety of sarilumab;
* To document the pharmacokinetic profile of sarilumab.

Detailed description:
The duration of the study period for each participant was approximately 22 weeks; including up to 4 weeks screening period, 12-week double-blind treatment period and 6-week safety follow-up period.

Participants who completed the 12-week treatment period were offered enrollment in a separate long-term extension study (LTS11210/NCT01146652).

Arms: arm 1: Placebo 2 mL to match sarilumab once a week (qw) and 0.5 mL to match golimumab every 4 weeks (q4w) on top of MTX (15-25 mg) qw for 12 weeks. arm 2: Golimumab 50 mg q4w and placebo (matched to sarilumab) qw on top of MTX (15-25 mg) qw for 12 weeks. arm 3: Sarilumab 150 mg qw and placebo (matched to golimumab) q4w on top of MTX (15-25 mg) qw for 12 weeks.
Interventions: intervention 1: Sarilumab intervention 2: Placebo intervention 3: Golimumab intervention 4: methotrexate (MTX) intervention 5: Folic/folinic acid
Intervention descriptions: intervention 1: Pharmaceutical form: solution for injection

Route of administration: subcutaneous intervention 2: Pharmaceutical form: solution for injection

Route of administration: subcutaneous intervention 3: Pharmaceutical form: solution for injection

Route of administration: subcutaneous intervention 4: Pharmaceutical form: tablet or solution for injection

Route of administration: Oral (tablet) or subcutaneous, intramuscular (solution) intervention 5: Pharmaceutical form: tablet

Route of administration: oral Folic/folinic acid continued according to local standard.

Protocol documents:
Clinical trial NCT01288469
Conditions: Hypercholesterolemia
Keywords: 10020603
Sponsor: Sanofi
Start date: 2011-01-01; Completion date: 2011-09-01
Enrollment: 92 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels compared with placebo when co-administered with 80 mg of atorvastatin after 8 weeks of treatment in participants with LDL-C ≥ 100mg/dL (≥ 2.59 mmol/L) on atorvastatin 10 mg.

Secondary Objectives:

* To evaluate the effects of alirocumab on other lipid levels in comparison with placebo, when co-administered with 80 mg of atorvastatin after 8 weeks of treatment.
* To evaluate the efficacy of alirocumab when co-administered with a high dose of atorvastatin (80 mg) versus atorvastatin 10 mg.
* To evaluate the safety and tolerability of alirocumab when co-administered with 2 different doses of atorvastatin.
* To evaluate the development of anti-alirocumab antibodies.
* To evaluate the pharmacokinetics of alirocumab.

Detailed description:
The duration of study participation depended on the status of the patient at screening:

* For participants receiving atorvastatin 10 mg at stable dose for at least 6 weeks prior to screening, the study participation was to be approximately 17 weeks including a screening period of 1 week, a double-blind treatment period of 8 weeks and a follow-up period of 8 weeks.
* For participants receiving a lipid lowering treatment other than atorvastatin/ or not at stable dose of atorvastatin 10 mg for at least 6 weeks prior to screening, or drug naive participants, the study participation was to be approximately 23 weeks with a screening period of 1 week, a run-in treatment period with atorvastatin 10 mg of 6 weeks, a double-blind treatment period of 8 weeks and a follow-up period of 8 weeks.

Arms: arm 1: Placebo (for alirocumab) subcutaneous (SC) administration every 2 weeks (Q2W) in combination with atorvastatin 80 mg orally once daily for 8 weeks. arm 2: Alirocumab 150 mg SC administration Q2W in combination with atorvastatin 10 mg orally once daily for 8 weeks. arm 3: Alirocumab 150 mg SC administration Q2W in combination with atorvastatin 80 mg orally once daily for 8 weeks.
Interventions: intervention 1: Alirocumab intervention 2: Placebo (for alirocumab) intervention 3: Atorvastatin intervention 4: Placebo (for atorvastatin)
Intervention descriptions: intervention 1: One subcutaneous (SC) injection in the abdomen only. intervention 2: One SC injection in the abdomen only. intervention 3: Over-encapsulated tablet orally once daily in the evening with dinner. intervention 4: One over-encapsulated tablet of placebo for atorvastatin orally once daily in the evening with dinner.

Protocol documents:
Clinical trial NCT00126568
Conditions: Anaplastic Thyroid Cancer Recurrent Thyroid Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-06-01; Completion date: 2011-09-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well sorafenib works in treating patients with advanced anaplastic thyroid cancer. Sorafenib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
OBJECTIVES:

I. Determine whether the objective response rate is ≥ 20% in patients with advanced anaplastic thyroid cancer treated with sorafenib.

II. Determine the survival of patients treated with this drug. III. Determine the safety profile of this drug in these patients. IV. Determine the pharmacokinetic predictors of response to this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed for survival.

Arms: arm 1: Patients receive oral sorafenib twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sorafenib tosylate
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00174187
Conditions: Endocrine System Diseases
Sponsor: Pfizer
Start date: 2000-09-01; Completion date: 2011-09-01
Enrollment: 30 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
* To assess the effect of a long-term treatment by Genotonorm on linear growth in children with short stature receiving steroid therapy
* To assess the effect of a long term treatment with Genotonorm on bone mineralisation
* To assess the effect of a long term treatment with Genotonorm on body composition

Detailed description:
This trial terminated on 10-Jun-2011 due to prolonged issues with drug accountability and data collection discrepancies. The decision to terminate was not based on any safety concerns.

Arms: arm 1: None
Interventions: intervention 1: Somatropin
Intervention descriptions: intervention 1: liquid, daily, until final height Dosage: 0,46 mg/kg/week . The maximum dose should not exceed 50 µg/Kg/day

Protocol documents:
Clinical trial NCT00254163
Conditions: B-Cell Chronic Lymphocytic Leukemia
Sponsor: US Oncology Research
Start date: 2003-12-01; Completion date: 2011-09-01
Enrollment: 184 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this research study is to find out what effects (good and bad) the combination of Nipent+Cytoxan+Rituxan has on CLL cancer compared to Fludara+Cytoxan+Rituxan. While all of these drugs are approved by the Food and Drug Administration (FDA) for the treatment of other cancers, these combinations are experimental for the treatment of CLL.

Detailed description:

Arms: arm 1: Fludarabine, Cyclophosphamide, and Rituximab (dosage based on day in cycle) arm 2: Pentostatin, Cyclophosphamide, and Rituximab (dosage depends on day in cycle)
Interventions: intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Rituximab intervention 4: Pentostatin
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00264381
Conditions: Superficial Thrombophlebitis Upper Extremity Superficial Thrombophlebitis Lower Extremity Superficial Thrombophlebitis
Keywords: Superficial Thrombophlebitis STP Fragmin Ibuprofen Superficial Thrombus Superficial Phlebitis phlebitis
Sponsor: University of Oklahoma
Start date: 2002-10-01; Completion date: 2011-09-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the hypothesis that Fragmin (dalteparin sodium) subcutaneously once daily for 7 days is more effective than Ibuprofen given orally three times daily for 7 days for the treatment of superficial thrombophlebitis (STP).

Detailed description:
Superficial thrombophlebitis is a common problem and is thought to affect up to 20% of patients with varicose veins. In the absence of treatment, STP may cause its greatest morbidity with extension of thrombus into the deep venous system and resultant risk of pulmonary embolism.

Current standard therapy for STP consists of local heat, elevation of the extremity, and non-steroidal anti-inflammatory medication. However, no study to date has adequately evaluated the effectiveness of this therapy despite persistence and recurrence of symptoms of STP in many patients.

The purpose of this study is to document the outcome of patients with objectively documented STP who are treated with NSAID therapy (standard care) verses those treated with low-molecular weight heparin (dalteparin sodium) according to a pre-defined treatment regimen.

All patients with documented upper or lower STP will be screened. Each will have a complete baseline and risk factor assessment.

All patients will be randomized in one of two treatment groups:

(a) Experimental group who will receive Fragmin (dalteparin)fixed dose subcutaneously daily for 7 days or (b) Control group who will receive ibuprofen 800mg given orally three times daily for 7 days. All patients will receive study drug for a period of 1-2 weeks with reassessment of STP by ultrasound.

All patients will participate for a period of 3 months with follow up visits at 7-9, and 14-16 day, and 1,3 months.

Arms: arm 1: Ibuprofen 800mg tid X 7 days + additional 7 days determined by protocol
Interventions: intervention 1: Dalteparin sodium injection
Intervention descriptions: intervention 1: Experimental group: dalteparin sodium 200units/kg subcutaneous on day one, followed by 10,000 units subcutaneous daily for six days plus placebo tablets taken orally three times daily for seven days. Control group: Ibuprofen 800mg orally three times daily for seven days plus placebo injection subcutaneous daily for seven days.

Protocol documents:
Clinical trial NCT00275834
Conditions: Obesity
Keywords: obesity treatment weight loss antiobesity drugs zonisamide
Sponsor: Duke University
Start date: 2006-01-01; Completion date: 2011-09-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary aim of this study is to assess long-term weight loss efficacy of zonisamide relative to placebo in obese patients prescribed a dietary intervention.

Detailed description:
This RCT compares two doses of zonisamide and placebo for one year. A total of 225 subjects are randomly assigned to one of the three treatment interventions at Duke University Medical Centre. The primary outcome measure is change in body weight in kilograms. Secondary outcomes include changes in waist circumference, glycaemic and inflammatory markers, lipids, food craving, hunger and satiety, quality of life, blood pressure and heart rate.

Arms: arm 1: Zonisamide 400 mg arm 2: Zonisamide 200 mg arm 3: matching placebo
Interventions: intervention 1: Zonisamide
Intervention descriptions: intervention 1: zonisamide 400 mg, 200 mg, or placebo

Protocol documents:
Clinical trial NCT00345046
Conditions: Glaucoma Cataract
Keywords: Glaucoma Cataract
Sponsor: Indiana University School of Medicine
Start date: 2002-09-01; Completion date: 2011-09-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Generic prednisolone acetate 1% is less effective than Pred Forte 1% or Econopred Plus 1%.

Detailed description:
Overall Study Design:

Structure:

This is a randomized, double-masked prospective study. The study medications will be masked and randomized by the outpatient pharmacy at Indiana University Hospital.

Duration:

Treatment duration: The duration of each subject's participation will be for up to 2 months after surgery. One hundred and two subjects will be enrolled over a twelve-month time span.

Controls:

Examiner, staff, and subjects are masked. Parallel group comparison.

Dosage/Dose Regimen/Instructions:

Subjects scheduled for glaucoma and/or cataract surgery will be recruited. Subjects may not be currently on any steroid or ophthalmic non-steroidal anti-inflammatory (NSAID) therapy for a minimum of 6 weeks prior to surgery. Subjects will be randomized to receive a dose of Pred Forte 1% (Allergan), Econopred Plus 1% (Alcon) or prednisolone acetate 1% (Falcon) four times a day starting immediately after finishing the surgery for two weeks, then twice a day for two more weeks. After 1 month of therapy subjects will stop or continue steroid treatment based on clinical findings. No other subconjunctival steroid or ointment will be used intra-operatively or post-operatively. The eye drop will be instilled per labeling instructions.

Arms: arm 1: Pred Forte 1% dosed four times daily decreasing to once daily over four weeks. arm 2: EconoPred Plus 1% dosed four times daily decreasing to once daily over four weeks. arm 3: Prednisolone Acetate 1% dosed four times daily decreasing to once daily over four weeks.
Interventions: intervention 1: Pred Forte intervention 2: EconoPred Plus intervention 3: Prednisolone Acetate
Intervention descriptions: intervention 1: Four drops daily decreasing to once daily over four weeks. intervention 2: Prednisolone Acetate four times daily decreasing to once daily over four weeks. intervention 3: Dosed four times daily decreasing to once daily over four weeks.

Protocol documents:
Clinical trial NCT00349973
Conditions: Schizophrenia Schizoaffective Disorder Schizophreniform Disorder
Keywords: Schizophrenia Positive symptoms Negative symptoms Cognitive deficits
Sponsor: University of Maryland, Baltimore
Start date: 2001-05-01; Completion date: 2011-09-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 6-week, randomized, double blind, parallel groups designed, olanzapine-controlled trial of oral dipyridamole in symptomatic patients with a (DSM IV) diagnosis of schizophrenia, schizoaffective or schizophreniform disorder. This pilot study aims to provide preliminary estimates of whether the effect sizes of dipyridamole on positive symptoms, negative symptoms, and cognitive deficits differ between schizophrenia patients treated with dipyridamole, and schizophrenia patients treated with olanzapine. A total of 30 subjects will be recruited locally.

Detailed description:
Since the demonstrated success of chlorpromazine in treating psychosis in the1950's, the pharmacotherapy of schizophrenia has focused mainly on drugs with antidopaminergic actions. These drugs have robust effects on reality distortion and disorganization symptom complexes, but minimal effect on cognitive impairment, negative symptoms, and functional outcome and quality of life measures. Newer generation antipsychotic drugs have a similar profile of effects, with some advantages on the course of depression, hostility, suicide, hospital readmission rates and motor side effect measures. Side effects such as weight gain, increase in cardiovascular stress and diabetes risk are associated with some new generation drugs. A new class of drugs is needed to address the inadequate effectiveness and the side-effect disadvantages of the currently available pharmacological agents for the treatment of schizophrenia. Recently, new treatment strategies using nicotinergic drugs or agonists at the glycine modulatory site of the glutamatergic N-methyl-D-aspartate (NMDA) receptor have been employed in clinical trials with mixed results. Our proposal focuses on a clinically available adenosine agonist, dipyridamole, in a 6-week clinical trial. Published data suggest effectiveness of dipyridamole in treating psychosis when added to haloperidol treatment. The effectiveness of dipyridamole alone in treating schizophrenia symptoms, although indirectly suggested by several lines of evidence, has not been tested.

Arms: arm 1: Dipyridamole arm 2: Olanzapine
Interventions: intervention 1: Dipyridamole intervention 2: Olanzapine
Intervention descriptions: intervention 1: Week 1- 50 mg bid Week 2- 50 mg am and 100 mg pm Weeks 3-6 100 mg am and 100 mg pm intervention 2: Week 1- 5 mg BID Week 2- 5 mg am and 10 mg pm Weeks 3-6 10 mg am and 10 mg pm

Protocol documents:
Clinical trial NCT00365547
Conditions: Lung Cancer
Keywords: recurrent non-small cell lung cancer stage IIIB non-small cell lung cancer stage IV non-small cell lung cancer adenocarcinoma of the lung bronchoalveolar cell lung cancer large cell lung cancer
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2006-09-01; Completion date: 2011-09-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as topotecan, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as Avastin (bevacizumab), can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Giving topotecan together with bevacizumab may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving topotecan together with bevacizumab works in treating patients with stage IIIB or stage IV non-small cell lung cancer that did not respond to previous systemic chemotherapy.

Detailed description:
OBJECTIVES:

Primary

* Determine the progression-free survival of patients with stage IIIB or IV non-small cell lung cancer treated with topotecan hydrochloride and bevacizumab who have failed prior systemic chemotherapy.

Secondary

* Determine the objective response rates in patients treated with this regimen.
* Measure time-to-event efficacy variables, including time to objective tumor response (for responding patients), duration of response (for responding patients), time to treatment failure, and overall survival.
* Characterize the quantitative and qualitative toxicities of this regimen in these patients.

OUTLINE: Patients receive topotecan hydrochloride intravenously (IV) over 30 minutes on days 1, 8, and 15 and Avastin (bevacizumab) IV over 30-90 minutes on days 1 and 15. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed every 3 months for 6 months from registration.

Arms: arm 1: Weekly topotecan hydrochloride and bi-weekly Avastin (bevacizumab) in patients with non-small cell lung cancer (NSCLC) who have failed prior systemic chemotherapy.
Interventions: intervention 1: bevacizumab intervention 2: topotecan hydrochloride
Intervention descriptions: intervention 1: Will be given by intravenous (IV) infusion at the dose of 10 mg/kg on days 1 and 15 after topotecan administration until disease progression or for another reason. intervention 2: Topotecan 4 mg/m\^2 intravenously (IV) will be given as a 30-minute intravenous infusion on days 1, 8, and 15 with a rest on day 22. Treatment will be repeated every 28 days until disease progression or for another reason.

Protocol documents: