ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00371683
Conditions: Deep Vein Thrombosis Pulmonary Embolism
Keywords: Prevention of deep vein thrombosis and pulmonary embolism after total knee replacement surgery
Sponsor: Bristol-Myers Squibb
Start date: 2006-11-01; Completion date: 2008-05-01
Enrollment: 3608 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to learn if apixaban can prevent blood clots in the leg (deep vein Thrombosis \[DVT\]) and lung (pulmonary embolism \[PE\]) that sometimes occur after knee replacement surgery and to learn how apixaban compares to enoxaparin (Lovenox®) for preventing these clots. The safety of apixaban will also be studied.

Detailed description:

Arms: arm 1: \+ placebo arm 2: \+ placebo
Interventions: intervention 1: Enoxaparin + Placebo intervention 2: Apixaban + Placebo
Intervention descriptions: intervention 1: Syringes + tablets, Subcutaneous + Oral, 30mg, twice daily, 12 day treatment period intervention 2: Tablet + Syringes, Oral + subcutaneous, 2.5 mg, twice daily, 12 day treatment period

Protocol documents:
Clinical trial NCT00479466
Conditions: Diabetes Mellitus, Type 2
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-07-01; Completion date: 2008-05-01
Enrollment: 342 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study to compare MK0893 to metformin or placebo for patients with Type 2 diabetes (Diabetes Mellitus).

Detailed description:

Arms: arm 1: MK0893 tablets totaling 80 mg once daily. arm 2: MK0893 tablets totaling 60 mg once daily. arm 3: MK0893 40 mg tablet once daily. arm 4: MK0893 20 mg tablet once daily. arm 5: Metformin HCL 500 mg tablet twice daily BID titrating up to 1000 mg twice daily over 3 weeks. arm 6: PLA tablets. 12 week treatment period.
Interventions: intervention 1: MK0893 intervention 2: Metformin intervention 3: Placebo to MK0893 intervention 4: Placebo to Metformin
Intervention descriptions: intervention 1: MK0893 taken orally once daily; 20 mg and 40 mg tablets used in combination according to dose. intervention 2: Metformin HCL 500 mg tablet twice daily titrating up to 1000 mg twice daily over 3 weeks. intervention 3: Dose-matched placebo tablets to MK0893; taken orally once daily. intervention 4: Dose-matched placebo tablets to metformin (500 mg); taken orally twice daily.

Protocol documents:
Clinical trial NCT00003477
Conditions: Visual Pathway Glioma
Keywords: visual pathway glioma not amenable to standard therapy visual pathway glioma not responding to standard therapy
Sponsor: Burzynski Research Institute
Start date: 1996-06-01; Completion date: 2008-05-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Current therapies for children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, provide limited benefit to the patient. The anti-cancer properties of Antineoplaston therapy suggest that it may prove beneficial in the treatment of children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.

PURPOSE: This study is being performed to determine the effects (good and bad) that Antineoplaston therapy has on children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.

Detailed description:
OBJECTIVES:

* To determine the efficacy of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, as measured by an objective response to therapy (complete response, partial response or stable disease).
* To determine the safety and tolerance of Antineoplaston therapy in children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy.

OVERVIEW: This is a single arm, open-label study in which children with visual pathway gliomas, which are not amenable to or have not responded to standard therapy, receive gradually escalating doses of intravenous Antineoplaston therapy (Atengenal + Astugenal) until the maximum tolerated dose is reached. Treatment continues for at least 12 months in the absence of disease progression or unacceptable toxicity. After 12 months, patients with a complete or partial response or with stable disease may continue treatment.

To determine objective response, tumor size is measured utilizing MRI scans, which are performed every 8 weeks for the first two years, every 3 months for the third and fourth years, every 6 months for the 5th and sixth years, and annually thereafter.

PROJECTED ACCRUAL: Approximately 20-40 patients will be accrued to this study.

Arms: arm 1: Antineoplaston therapy (Atengenal + Astugenal) by IV infusion every four hours for at least 12 months. Study subjects receive increasing dosages of Atengenal and Astugenal until the maximum tolerated dose is reached.
Interventions: intervention 1: Antineoplaston therapy (Atengenal + Astugenal)
Intervention descriptions: intervention 1: Children with a visual pathway glioma, which is not amenable to standard therapy or has not responded to standard therapy, will receive Antineoplaston therapy (Atengenal + Astugenal).

Protocol documents:
Clinical trial NCT00003656
Conditions: Kidney Cancer
Keywords: stage IV renal cell cancer recurrent renal cell cancer
Sponsor: Weill Medical College of Cornell University
Start date: 1999-01-01; Completion date: 2008-05-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Tretinoin may help kidney cancer cells develop into normal cells. Interferon alfa may interfere with the growth of cancer cells.

PURPOSE: Phase II trial to study the effectiveness of liposomal tretinoin plus interferon alfa in treating patients who have metastatic kidney cancer.

Detailed description:
OBJECTIVES:

* Determine the response in patients with metastatic renal cell carcinoma treated with tretinoin liposome and interferon alfa-2b.
* Determine the toxicity of this regimen in these patients.
* Study retinoic acid receptor expression on tissue obtained from selected patients who have tumor biopsies.

OUTLINE: This is a dose-escalation study of tretinoin liposome with concurrent individual dose escalation of interferon alfa-2b. (Phase I closed to accrual as of 9/24/03.)

Patients receive tretinoin liposome IV over 30 minutes once weekly and interferon alfa-2b subcutaneously on five consecutive days (M-F) for 8 weeks. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Cohorts of 3-6 patients receive escalating doses of tretinoin liposome until the maximum tolerated dose (MTD) has been determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Once the MTD is determined additional patients are accrued and treated at that dose. (Phase I closed to accrual as of 9/24/03.)

During the first 3 weeks of the study, patients receive interferon alfa-2b at weekly dose escalations. After week 3, patients continue at the highest acceptable dose level of interferon alfa-2b for the remainder of the study. (Phase I closed to accrual as of 9/24/03.)

Patients are followed at 30 days after the last treatment.

PROJECTED ACCRUAL: A total of 3-18 patients will be accrued into the phase I portion of this study (Phase I closed to accrual as of 9/24/03). A total of 14-25 patients will be accrued into the phase II portion of this study.

Arms: arm 1: Weekly ATRA-IV with recombinant interferon alfa
Interventions: intervention 1: recombinant interferon alfa intervention 2: tretinoin liposome
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00003869
Conditions: Stage IIIA Non-small Cell Lung Cancer Stage IIIB Non-small Cell Lung Cancer Stage IV Non-small Cell Lung Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 1999-04-01; Completion date: 2008-05-01
Enrollment: 186 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized phase III trial to determine the effectiveness of carboxyamidotriazole in treating patients who have stage III or stage IV non-small cell lung cancer. Chemotherapeutic agents are modestly effective for the treatment of advanced lung cancer, with rapid tumor relapse and growth even after initial response to therapy. It is not yet known whether carboxyamidotriazole is more effective than no further treatment after standard chemotherapy for non-small cell lung cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To determine whether oral administration of the carboxyaminoimidazole (CAI) is more effective than placebo in prolonging the overall survival in patients with non-small cell lung cancer stage III or stage IV non-small cell lung cancer who have been stable or had tumor regression following chemotherapy.

SECONDARY OBJECTIVES:

I. To evaluate the safety and tolerability of oral CAI following chemotherapy. II. To determine whether CAI prolongs time-to-disease progression relative to a placebo.

III. To evaluate whether a substantive effect in quality of life (QOL) can be detected between the CAI and placebo groups using the FACT-L and the UNISCALE.

IV. To document the response rate to CAI in patients with measurable or evaluable disease.

TERTIARY OBJECTIVES:

I. To evaluate genotypes at GSH-related loci as predictors of overall survival.

OUTLINE: This is a randomized, double-blind, multicenter study. Patients are stratified according to timing of first-line therapy (prior to registration vs after registration), disease stage (IIIA vs IIIB vs IV), therapy components (chemotherapy and thoracic radiotherapy vs chemotherapy only), ECOG performance status (0 vs 1 vs 2) and participating center. Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral carboxyamidotriazole daily.

ARM II: Patients receive oral placebo daily.

Treatment continues in the absence of disease progression or unacceptable toxicity.

Quality of life is assessed at baseline and then monthly during study.

Patients are followed every 3 months for 5 years.

Arms: arm 1: Patients receive oral carboxyamidotriazole daily. arm 2: Patients receive oral placebo daily
Interventions: intervention 1: carboxyamidotriazole intervention 2: placebo intervention 3: quality-of-life assessment intervention 4: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Ancillary studies intervention 4: Correlative studies

Protocol documents:
Clinical trial NCT00045487
Conditions: Kidney Cancer
Keywords: recurrent renal cell cancer stage III renal cell cancer stage IV renal cell cancer
Sponsor: The University of Texas Health Science Center at San Antonio
Start date: 2002-06-01; Completion date: 2008-05-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Erlotinib may stop the growth of tumor cells by blocking the enzymes necessary for tumor cell growth.

PURPOSE: Phase II trial to study the effectiveness of erlotinib in treating patients who have advanced kidney cancer.

Detailed description:
OBJECTIVES:

* Determine the antitumor activity of erlotinib in patients with advanced renal cell carcinoma.
* Evaluate the safety and tolerability, in terms of the toxicity profile, of this drug in these patients.
* Determine the biologic activity of this drug, in terms of early disease progression, progression-free survival, 12-month survival rate, and overall survival, in these patients.
* Determine the pharmacodynamics of this drug in these patients.
* Analyze the postreceptor effects of epidermal growth factor receptor-tyrosinase kinase inhibition by this drug on cell cycle, apoptosis, and angiogenesis in tumor biopsies from these patients.
* Correlate changes in biological measurements with indices of outcome in patients treated with this drug.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral erlotinib once daily on days 1-28. Courses repeat every 4 weeks for 52 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 2 months.

PROJECTED ACCRUAL: A total of 19-40 patients will be accrued for this study within 8-10 months.

Arms: arm 1: None
Interventions: intervention 1: OSI-774
Intervention descriptions: intervention 1: OSI-774 is an orally active, potent, selective inhibitor of the epidermal growth factor receptor (EGFR) tyrosine kinase.

Protocol documents:
Clinical trial NCT00060944
Conditions: Liposarcoma Leiomyosarcoma
Keywords: Trabectedin Yondelis ET-743 Ecteinascidin Anthracycline Ifosfamide Dexamethasone Intravenous Cancer Malignant Metastatic
Sponsor: Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Start date: 2003-05-01; Completion date: 2008-05-01
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the safety and effectiveness of an investigational chemotherapy agent in patients with types of advanced cancer referred to as liposarcoma or leiomyosarcoma.

Detailed description:
This is an open-label (patients will know the names of the study drugs they receive), randomized (patients will be assigned by chance to receive 1 of 2 treatment schedules with trabectidin) study designed to examine the the survival, safety, and pharmacokinetics (blood levels) trabectedin when administered to patients with 2 types of cancer (Liposarcoma or Leiomyosarcoma) who have received treatment with other anti-cancer therapy (Anthracycline and/or Ifosfamide). Trabectedin (also referred to as Yondelis) is a drug being developed to treat patients with cancer. Yondelis will be administered intravenously (i.v.) via a central catheter (tube) into a central vein once a week (0.58 mg/m2 as a 3-hour infusion on Days 1, 8, and 15 of each 28-day treatment cycle) or once every 3 weeks (1.5 mg/m2 administered as a 24-hour infusion on Day 1 of every 21-day treatment cycle) until disease progression. Patients in each arm will be pretreated with 20 mg of dexamethasone i.v. 30 minutes prior to each infusion.

Arms: arm 1: Yondelis weekly schedule: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1 8 and 15 of each 28-day treatment cycle. Patients will be pretreated with 10 mg of dexamethasone i.v. 30 minutes prior to each infusion. arm 2: Yondelis once every 3 weeks schedule: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. Patients will be pretreated with 20 mg of dexamethasone i.v. on Day 1 of each treatment cycle 30 minutes prior to each infusion.
Interventions: intervention 1: Yondelis intervention 2: Yondelis intervention 3: Dexamethasone intervention 4: Dexamethasone
Intervention descriptions: intervention 1: 1.5 mg/m2 administered as a 24-hour i.v. infusion on Day 1 of every 21-day treatment cycle. intervention 2: 0.58 mg/m2 administered as a 3-hour i.v. infusion on Days 1, 8, and 15 of each 28-day treatment cycle. intervention 3: Pretreatment with 10 mg of dexamethasone i.v. 30 minutes prior to each Yondelis infusion on Days 1, 8, and 15 of each 28-day treatment cycle. intervention 4: Pretreatment with 20 mg of dexamethasone i.v. on Day 1 of each 21- day treatment cycle, 30 minutes prior to each Yondelis infusion.

Protocol documents:
Clinical trial NCT00074802
Conditions: Social Anxiety Disorder
Keywords: Social Phobia
Sponsor: Temple University
Start date: 2003-12-01; Completion date: 2008-05-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will examine whether the addition of cognitive behavioral therapy can improve the efficacy of the medication paroxetine (Paxil®) in treating individuals with social anxiety disorder. Patients with social anxiety disorder will undergo a 12-week open trial with paroxetine. Those who complete the open trial having achieved only partial response will be randomized to receive cognitive behavioral therapy (CBT) in addition to paroxetine or to continue on paroxetine alone for an additional 16 weeks.

Detailed description:
Social anxiety disorder is a prevalent and disabling condition for which effective long-term treatments need to be identified. Paroxetine is effective in treating the acute symptoms of social anxiety, but many patients achieve less than optimal response. CBT has also been effective in treating social anxiety disorder; thus,it may also be effective in augmenting paroxetine response. This study will examine the effects of paroxetine treatment alone and in combination with CBT among patients who achieve less than optimal response after an open trial with paroxetine.

Participants in this study will receive paroxetine for 12 weeks (Phase 1). After 12 weeks, participants who have completed this open trial but have achieved some but less than optimal response will move forward to Phase 2. To be eligible to move forward to Phase 2, patients must have achieved at least a 10% improvement in their open-trial Liebowitz Social Anxiety Scale Scores (LSAS) but still have an LSAS score of 30 or greater. Patients meeting these criteria will be randomly assigned to either add weekly sessions of CBT to their treatment or to continue taking paroxetine alone for another 16 weeks. Social anxiety symptoms, rates of response and remission, fear of negative evaluation, disability and quality of life will be assessed.

Arms: arm 1: Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine for 16 additional weeks. arm 2: Participants who showed only partial response to paroxetine in Phase 1 will receive continued treatment with paroxetine plus cognitive behavioral therapy (CBT) for 16 additional weeks.
Interventions: intervention 1: Paroxetine intervention 2: Cognitive behavioral therapy (CBT)
Intervention descriptions: intervention 1: Treatment with paroxetine will consist of an immediate release, flexible dosage of 20 to 50 mg per day. intervention 2: CBT will consist of 16 weekly treatment sessions.

Protocol documents:
Clinical trial NCT00090844
Conditions: Breast Cancer Hormone Changes Drug Toxicity
Keywords: drug/agent toxicity by tissue/organ hormone changes stage I breast cancer stage II breast cancer
Sponsor: University of South Florida
Start date: 2004-07-01; Completion date: 2008-05-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Drugs used in chemotherapy work in different ways to stop tumor cells from dividing so they stop growing or die. Chemoprotective drugs, such as triptorelin, may protect normal ovarian cells from the side effects of chemotherapy.

PURPOSE: This randomized phase II trial is studying how well triptorelin works in preserving ovarian function in premenopausal women who are receiving chemotherapy for early-stage breast cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the protective effect of chemical ovarian suppression using triptorelin on the preservation of ovarian function in premenopausal women with early-stage operable breast cancer undergoing adjuvant or neoadjuvant systemic chemotherapy.

Secondary

* Determine the rate of chemotherapy-related amenorrhea in patients treated with this drug.
* Determine the value of inhibin A and B as alternative markers of premature ovarian failure in patients treated with this drug.
* Determine quality of life of patients treated with this drug.
* Determine disease-free and overall survival of patients treated with this drug.

OUTLINE: This is a randomized, multicenter study. Patients are stratified according to age (\< 35 years vs 35 to 39 years vs \> 39 years); concurrent neoadjuvant or adjuvant systemic chemotherapy (fluorouracil, epirubicin, and cyclophosphamide \[6 courses\] OR fluorouracil, doxorubicin, and cyclophosphamide \[6 courses\] vs doxorubicin and cyclophosphamide \[AC\] \[4 courses\] vs doxorubicin and cyclophosphamide \[AC\] \[4 courses\] followed by a taxane \[4 courses\]); and hormone receptor status (estrogen receptor \[ER\]- AND progesterone receptor \[PR\]-negative vs ER- OR PR-positive).

* Arm I: Beginning within 1-4 weeks before the start of chemotherapy, patients receive triptorelin intramuscularly once monthly for 4-6 months during neoadjuvant or adjuvant systemic chemotherapy.
* Arm II: Patients receive neoadjuvant or adjuvant systemic chemotherapy only. Quality of life is assessed at baseline, monthly during treatment, every 6 months for 2 years, and then annually for 3 years.

Patients are followed every 6 months for 2 years and then annually for 3 years.

PROJECTED ACCRUAL: A total of 138 patients (69 per treatment arm) will be accrued for this study within 35 months.

Arms: arm 1: GnRH analogue (triptorelin) during chemotherapy arm 2: No GnRH analogue (triptorelin) during chemotherapy
Interventions: intervention 1: triptorelin
Intervention descriptions: intervention 1: 3.75 mg TRELSTAR DEPOT (triptorelin) administered monthly as single intramuscular injection

Protocol documents:
Clinical trial NCT00105066
Conditions: Obesity Hypertension Hypercholesterolemia Hyperglycemia
Keywords: Metabolic Syndrome triglycerides HDL LDL High Blood Pressure High Cholesterol High Blood Sugar
Sponsor: National Institute on Aging (NIA)
Start date: 2004-01-01; Completion date: 2008-05-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate whether the drug Metformin has beneficial effects on the blood vessels of individuals with the Metabolic Syndrome (MeS).

Detailed description:
Individuals with the Metabolic Syndrome (MeS) are at increased risk for developing cardiovascular diseases. This increased risk may, in part, be related to abnormalities in the blood vessels. MeS is defined as having 3 or more of the following 5 criteria:

* Abdominal obesity (waist measurement \>39.8 inches in men, \>34.4 inches in women)
* Elevated triglycerides (\>150 mg/dl)
* Low HDL or "good" cholesterol (\<40 mg/dl in men or \<50 mg/dl in women)
* Elevated blood pressure (\>130/85) or treatment for high blood pressure
* Elevated fasting blood sugar (\>100 mg/dl)

Metformin is a medication that is approved by the Food and Drug Administration (FDA) for the treatment of diabetes; however, it can also be safely administered to non-diabetic subjects. We are evaluating whether Metformin reduces the stiffness of blood vessels and improves endothelial function.

This study requires 4 visits to the NIA Clinical Research Center (located on the premises of Harbor Hospital) over a 5-month period. At the initial visit, patients will be given a physical examination with blood and urine tests, and an EKG. They will be randomized into one of two groups; one group will receive Metformin (1700 mg per day), while the other group will receive a placebo. Participants will take the medication for 4 months. Subsequent visits will include additional blood tests, ultrasound and echo exams.

Taking part in this study is entirely voluntary. All testing and medications will be provided at no cost to the participant or their family.

Arms: arm 1: placebo arm 2: Metformin 850 mg twice daily
Interventions: intervention 1: Metformin intervention 2: Placebo
Intervention descriptions: intervention 1: 850mg tablet once a day for one month, then twice a day for 3 months intervention 2: placebo tablet once a day for one month, then twice a day for 3 months

Protocol documents: