ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00176644
Conditions: Prostate Cancer
Keywords: prostate cancer
Sponsor: University of Medicine and Dentistry of New Jersey
Start date: 2005-05-01; Completion date: 2008-12-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Multiple trials have shown the efficacy of estrogen therapy in metastatic prostate cancer, and most recently trials have supported the use of transdermal estrogens (patch) in the patient population with a decreased risk of cardiovascular disease as compared to the oral estrogens. We plan to study the use of transdermal estrogen at a dose of 0.4mg qd. We will evaluate the toxicities and measure quality of life. We will assess PSA response and measurable disease response. This will be a trial available to the Cancer Institute of New Jersey Oncology Group. We will enroll a total of 33 patients. We will plan to enroll 10 at CINJ.Patients will wear the patches (4) continuously. We will obtain blood work and clinic evaluations every three weeks. We will assess quality of life through a questionnaire given to patient every three weeks.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Transdermal Estradiol
Intervention descriptions: intervention 1: application of 4 transdermal estradiol patches, each patch releases a dose of 0.1 mg/day for a total dose of 0.4 mg/day. All four patches will be changed every 7 days. This continuous weekly schedule will be followed until the patient goes off-study.

The patch will be applied to a clean, dry, intact area of the lower abdomen or the upper quadrant of the buttock. The sites should be rotated weekly. If a patch falls off during the 7 days, a new patch will be applied for the remainder of the 7 day period. At the end of the 7 days all four patches will be changed.

Protocol documents:
Clinical trial NCT00177255
Conditions: Cancer
Keywords: gastric stomach esophagus esophageal
Sponsor: University of Pittsburgh
Start date: 2005-04-01; Completion date: 2008-12-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas.

Detailed description:
This is a phase II study that will investigate weekly dosing of docetaxel in combination with capecitabine in advanced gastric and gastro-esophageal adenocarcinomas. Docetaxel 30mg/m2 will be administered on days 1 and 8 of each cycle and capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14) of each cycle. Each cycle is 21 days. Subjects will receive unlimited cycles of docetaxel and capecitabine until there is evidence of disease progression or unacceptable side effects.

Arms: arm 1: Docetaxel 30mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days. Premedication with dexamethasone will be given to all patients receiving weekly docetaxel therapy to reduce the incidence and severity of fluid retention as well as the severity of hypersensitivity reactions. Cycle 2 will begin on day 22.

Capecitabine Capecitabine 825mg/m2 bid (total daily dose 1650mg/m2) will be administered orally for 14 days (days 1-14).

Each cycle will consist of 21 days. Cycle 2 will begin on day 22.
Interventions: intervention 1: Docetaxel intervention 2: Capecitabine
Intervention descriptions: intervention 1: Docetaxel 30 mg/m2 will be administered as a 30-minute infusion on days 1 and 8. Each cycle will consist of 21 days.

Cycle 2 will begin on day 22. intervention 2: Capecitabine 825 mg/m2 bid (total daily dose 1650 mg/m2) will be administered orally for 14 days (days 1-14).

Each cycle will consist of 21 days.

Cycle 2 will begin on day 22.

Protocol documents:
Clinical trial NCT00185380
Conditions: Contraception
Sponsor: Bayer
Start date: 2005-04-01; Completion date: 2008-12-01
Enrollment: 742 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate if drug doses lower than the one released from Mirena® would be as effective for contraception as Mirena®. Subjects participating in the study will be randomly assigned to be inserted with any of the three different intrauterine systems (IUSs). The IUSs are nearly alike except that the amount of hormone released from them is different.

Detailed description:
The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.

Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Although the title of the study describes "open", it was in fact single-blinded.

Issues on side effects are addressed in the Adverse Event section.

Arms: arm 1: Levonorgestrel intrauterine contraceptive system (LCS) releasing 12 microg/24h in vitro arm 2: Levonorgestrel intrauterine contraceptive system (LCS) releasing 16 microg/24h in vitro arm 3: Levonorgestrel intrauterine system (IUS) releasing 20 microg/24h in vitro
Interventions: intervention 1: Levonorgestrel IUS (BAY86-5028, G04209B) intervention 2: Levonorgestrel IUS (BAY86-5028, G04209C) intervention 3: Levonorgestrel IUS (Mirena, BAY86-5028)
Intervention descriptions: intervention 1: Levonorgestrel intrauterine contraception system (IUS) releasing 12 microg/24 h in vitro, to be used for three years intervention 2: Levonorgestrel intrauterine contraception system (IUS) releasing 16 microg/24 h in vitro, to be used for three years intervention 3: Levonorgestrel Intrauterine contraception system (IUS) releasing 20 microg/24 h to be used for three years

Protocol documents:
Clinical trial NCT00193427
Conditions: Lung Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2004-04-01; Completion date: 2008-12-01
Enrollment: 75 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This trial is designed to study the role of docetaxel/gemcitabine, an active and relatively non-toxic combination in advanced NSCLC. This study will help to better define optimal preoperative regimens for patients with resectable NSCLC. Since both of these drugs are potent radio-sensitizers, the concurrent use with radiation therapy at these weekly doses may produce not only radio-sensitization, but also considerable antitumor efficacy.

Detailed description:
Upon determination of eligibility, patients will receive:

Pre-operative

* Docetaxel
* Gemcitabine Post-operative
* Docetaxel
* Carboplatin
* Radiation Therapy

Patients with stage IB and II NSCLC who achieved clear margins will not receive any further therapy. Patients with incomplete resection, resection margins of a T3 tumor that are positive or close, stage IIIA AND IIIB NSCLC or disease judged unresectable after preoperative chemotherapy will receive postoperative treatment

Arms: arm 1: Patients with potentially resectable clinical stage IB, II, and selected III NSCLC received gemcitabine 1000 mg/m2 days 1, 8 and docetaxel 30 mg/m2 days 1, 8 every 21 days for 3 cycles. Patients were restaged after treatment and resected 3-6 weeks later. If patients were inoperable, had incomplete resections or N2 disease, docetaxel 20 mg/m2 and carboplatin AUC = 1.5 weekly x 7 and radiation to 63 Gy was administered
Interventions: intervention 1: Docetaxel intervention 2: Gemcitabine intervention 3: Carboplatin intervention 4: Radiation
Intervention descriptions: intervention 1: 30mg/m2 administered on days 1 and 8, 21-cycle days, 3 cycles intervention 2: 1000 mg/m2 administered by 30-minute IV infusion on day 1 and 8, 21-cycle days, 3 cycles intervention 3: AUC = 1.5 weekly x 7 intervention 4: To 63 Gy

Protocol documents:
Clinical trial NCT00216203
Conditions: Non-Small Cell Lung Cancer
Keywords: Non-Small Cell Lung Cancer
Sponsor: Nasser Hanna, M.D.
Start date: 2005-05-01; Completion date: 2008-12-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Both pemetrexed and cetuximab have single agent activity in NSCLC and non-overlapping toxicity profiles. While 2-drug combination therapy has proven superior to single agent therapy in the first-line setting of NSCLC, no such phase III trials have been reported in the second-line setting. Therefore, the purpose of this study is to determine the feasibility of combining these drugs, assessing the toxicity profile, determining the MTD and evaluating the activity of the combination in an expanded phase II setting. If the combination appears to have promising activity, further evaluation of this regimen may be warranted comparing it to single agent pemetrexed or cetuximab alone.

Detailed description:
OUTLINE: This is a multi-center study.

Week 1 (day 1):

* Cetuximab 400mg/m2

Week 2 (Cycle 1, Day 1):

* Cetuximab 250mg/m2 plus premetrexed at the assigned dose level.

Patients will be treated with cetuximab on day 1, 8, 15 of each 21 day cycle.

Patients will be treated with pemetrexed on day 1 of each 21 day cycle for a maximum of 6 cycles.

Acceptable toxicity and SD, PR or CR: treat up to 6 cycles then continue cetuximab weekly until PD or excess toxicity

Performance status: ECOG 0-2

Life expectancy: At least 12 weeks

Hematopoietic:

* ANC \> 1,500/mm3
* Platelets \> 100,000/mm3

Hepatic:

* Bilirubin less than or equal to the upper limit of normal (ULN)
* Aspartate aminotransferase (AST) \< 1.5 X ULN. AST may be \< 5 X ULN for patients with liver metastases
* Alkaline phosphatase \< 5 X ULN

Renal:

* Calculated creatinine clearance \> 45 mL/min (by Cockcroft-Gault)

Cardiovascular:

* No significant history of uncontrolled cardiac disease (i.e., uncontrolled hypertension, unstable angina, and congestive heart failure)

Pulmonary:

* Not specified

Arms: arm 1: Pemetrexed + cetuximab for patients with recurrent non-small cell lung cancer.
Interventions: intervention 1: Pemetrexed intervention 2: Cetuximab
Intervention descriptions: intervention 1: Pemetrexed at the assigned dose, day 1 of each 21 day cycle for a maximum of 6 cycles intervention 2: Cetuximab 400 mg/m2, week 1, day 1

Cetuximab 250 mg/m2, day 1, 8, 15 of each 21 day cycle

Protocol documents:
Clinical trial NCT00227370
Conditions: Cytomegalovirus Infections
Keywords: Acute rejection Non-CMV infections Resistance
Sponsor: Duke University
Start date: 2003-07-01; Completion date: 2008-12-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study evaluated the efficacy and safety of a prolonged, continuous course of Valganciclovir (Valgan) in the prevention of CMV by comparing 3 months of Vaglanciclovir, the standard of care upon initiation of the study, to 12 months of Valganciclovir.

Detailed description:
A multi-center two phase, double-blind, placebo controlled, randomized prospective study of 130 lung transplant recipients. Patients will be screened and consented prior to transplant. All consented patients will receive IV ganciclovir within 24 hours of transplant for not more than 14 days. Patients will enroll in Phase I of the study is an open label safety and efficacy analysis of three months of oral valganciclovir in adult transplant recipients who are at risk for CMV. After completion of 3 months of open label therapy, patients that meet the criteria for Phase II of the study will be randomized to 9 months of blinded therapy (Placebo/Valgan). Phase II of the study is designed to assess the efficacy of short course sequential IV ganciclovir followed by oral valganciclovir as compared to the extended period of oral valganciclovir prophylaxis in the prevention of CMV disease in at risk lung transplant recipients

Arms: arm 1: Valganciclovir 900 mg QD for 9 months post lung transplant. arm 2: placebo for 9 months post lung transplant
Interventions: intervention 1: valganciclovir intervention 2: Placebo
Intervention descriptions: intervention 1: valgan 900mg QD x 9 months post lung transplant intervention 2: None

Protocol documents:
Clinical trial NCT00233090
Conditions: Fatigue
Keywords: Fatigue TBI brain injury Modafinil traumatic brain injury
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2005-07-01; Completion date: 2008-12-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized clinical trial of modafinil vs. placebo for treatment of fatigue after TBI.

Detailed description:
Purpose: The purpose of this study is to examine the efficacy of the drug modafinil as a treatment for fatigue post TBI.

Background: After TBI, fatigue is one of the most common complaints, as documented in our work and that of many other researchers. People with TBI experience fatigue that seems to them out of proportion to whatever work they are doing or effort they are making. Fatigue after TBI is associated with decreased participation in normal activities in the community and has been linked to depression.

Need for Research: Research on use of drugs to treat post-TBI fatigue is inadequate. While studies of fatigue in people with other chronic conditions suggest that modafinil helps relieve fatigue and has fewer side effects than some other drugs used in treating fatigue, the use of modafinil has not yet been tested in people with TBI.

Current and Future Research Activity: More than 100 men and women volunteers who complain of post-TBI fatigue will be randomly assigned to a 4-week period of taking modafinil or a placebo. At the beginning and end of the study, the severity of their fatigue and associated symptoms (e.g., cognitive function, mood, pain, daytime sleepiness, sleep quality, health status) will be assessed, as well as their participation in activities and perceived quality of life. It is hypothesized that modafinil will reduce the symptoms of fatigue and will increase level of activity and perceived quality of life to a significantly greater extent than will the placebo.

Arms: arm 1: single dose of 200 mg. a day of modafinil for four weeks arm 2: None
Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: single dose of 200 mg. a day of modafinil for four weeks intervention 2: daily dose of placebo for four weeks.

Protocol documents:
Clinical trial NCT00234065
Conditions: Cerebral Infarction
Sponsor: Otsuka Pharmaceutical Co., Ltd.
Start date: 2003-12-01; Completion date: 2008-12-01
Enrollment: 2800 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the efficacy of cilostazol in preventing recurrence of cerebral infarction and the safety of long-term administration of the drug (100 mg, twice daily) in patients with cerebral infarction (excluding cardiogenic cerebral embolism) in a multi-center, double-blind, parallel-group comparison with aspirin (81 mg, once daily).

Detailed description:

Arms: arm 1: cilostazol arm 2: Aspirin
Interventions: intervention 1: Cilostazol intervention 2: Aspirin
Intervention descriptions: intervention 1: oral tablet, 100 mg twice a day and placebo of aspirin once a day, 1 to 5years intervention 2: oral tablet, placebo of cilostazol twice a day and 81 mg once a day, 1 to 5 years

Protocol documents:
Clinical trial NCT00240162
Conditions: Multiple Myeloma
Keywords: Myeloma PTK
Sponsor: Washington University School of Medicine
Start date: 2005-09-01; Completion date: 2008-12-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study it to evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are \< 5 g/dL following high dose chemotherapy (HDCT) and autologous stem cell transplantation (ASCT).

Detailed description:
To evaluate the efficacy of PTK787/ZK 222584, in inducing at least a 50% reduction in paraprotein in patients with multiple myeloma whose paraprotein levels are \< 5 g/dL following high dose chemotherapy (HDCT) and Autologous Stem Cell Transplantation (ASCT).

To assess the time to progression and disease free survival of patients treated with PTK787/ZK 222584.

To assess the safety and tolerability of PTK787/ZK 222584 in multiple myeloma patients following ASCT.

Arms: arm 1: Initially patients will receive a dose of 500mg (2, 250mg tablets) in the morning and 250mg (1, 250mg tablet) in the afternoon for 2 weeks (cycle 1, days 1-14), then 500mg (2, 250mg tablets) bid for 2 weeks (cycle 1, days 15-28) and finally 750mg (3, 250mg tablets) in the morning and 500mg (2, 250mg tablets) in the afternoon for the remainder of treatment duration (cycle 2, day 1 and onwards). Each 28 days of drug administration will constitute one cycle of therapy.
Interventions: intervention 1: PTK787/ZK 222584
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00246259
Conditions: Schizophrenia Schizoaffective Disorder Schizophreniform Disorder Psychotic Disorders
Keywords: Schizophrenia Schizoaffective disorder Schizophreniform disorder Risperidone Risperdal Consta
Sponsor: Janssen-Ortho Inc., Canada
Start date: 2004-10-01; Completion date: 2008-12-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effectiveness, safety and tolerability of risperidone long-acting injection (LAI) versus oral antipsychotics in participants with recent onset psychosis (abnormal thinking and/or hallucinations).

Detailed description:
This is an open-label (all people know identity of intervention), randomized (the study drug is assigned by chance), multicenter (conducted in more than 1 center), and exploratory study in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality) or schizoaffective disorder (mixed psychiatric disorder relating to complex psychotic state that has features of both schizophrenia and mood disorder). Duration of this study will be 24 months. Study assessment visits will be conducted at Screening, Baseline, Week 2, every 4 weeks till Week 22, at Week 28, every 12 weeks till Week 88 and at Week 104. All eligible participants will receive either risperidone long acting injection 25 milligram (mg) intramuscularly (into the muscle) along with their current oral medication (atypical antipsychotic - risperidone, quetiapine, olanzapine) or only their current oral medication. Efficacy will be evaluated primarily by Positive and Negative Syndromes Scale (PANSS), time to relapse and Social and Occupational Functioning Assessment Scale (SOFAS). Participants's safety will be evaluated throughout the study mainly by Abnormal Involuntary Movement Scale (AIMS), Barnes Akathisia Rating Scale (BARS), and Simpson Angus Scale (SAS).

Arms: arm 1: Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion. An oral atypical antipsychotic will also be administered in the first 3 weeks following initiation of Risperidone LAI, and for a maximum of 3 weeks following a dose increase. arm 2: Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg. Participants will be switched to another oral therapy as per Investigator's discretion.
Interventions: intervention 1: Risperidone long-acting injection (LAI) intervention 2: Oral Antipsychotic
Intervention descriptions: intervention 1: Risperidone LAI 25 mg, 37.5 mg or 50 mg intramuscular injection will be administered every 2 weeks as per Investigator's discretion. intervention 2: Oral antipsychotic (new or current treatment) will be administered in which daily dose range permitted will be risperidone 6 mg; olanzapine 20 mg; quetiapine 800 mg.

Protocol documents:
Clinical trial NCT00247624
Conditions: Sleep Initiation and Maintenance Disorders Depression
Keywords: Depression Hypnotics Sleep Quality of Life Insomnia Suicide
Sponsor: Wake Forest University Health Sciences
Start date: 2005-10-01; Completion date: 2008-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and effectiveness of treatment with both a sleeping pill and antidepressant medication in improving sleep and psychological functioning in people with depression and insomnia.

Detailed description:
Chronic insomnia is one of the most common symptoms that individuals experience during a major depressive episode. Insomnia may lead to increased risk for recurrence of major depression, as well as poor quality of life and increased risk of suicide. Studies have shown that treating insomnia during a major depressive episode may not only help reduce symptoms of major depression during the day, but also improve an individual's general quality of life. Thus, sleeping pills, also known as hypnotics, are commonly prescribed for people with psychiatric disorders. However, little is known about the safety and efficacy of combining sleeping pills with antidepressant medications. This study will evaluate the safety and effectiveness of treatment with both a sleeping pill and antidepressant medication in improving sleep and psychological functioning in people with depression and insomnia.

Participants in this double-blind study will first receive fluoxetine, an antidepressant medication, for 1 week. Participants whose symptoms of insomnia subside after this initial week will continue on fluoxetine for the duration of the study and will not receive sleeping pills. Those who do not experience an improvement in their symptoms of insomnia after 1 week will be randomly assigned to receive either placebo or eszopiclone, which is a sleeping pill, in addition to fluoxetine. All treatments will be given for 8 weeks. Participants will attend study visits at various points throughout the treatment phase. Follow up visits will occur periodically over the next 4 months. Assessments will include physiological measures during sleep, mood, suicidal thinking, quality of life and actigraphy, which measures the amount of movement during sleep.

Arms: arm 1: Participants will receive treatment with eszopiclone and fluoxetine arm 2: Participants will receive treatment with placebo and fluoxetine
Interventions: intervention 1: Eszopiclone intervention 2: Fluoxetine intervention 3: Placebo
Intervention descriptions: intervention 1: Eszopiclone 3 mg every night for 8 weeks intervention 2: Fluoxetine 20 mg every morning for 9 weeks intervention 3: Placebo every night for 8 weeks

Protocol documents:
Clinical trial NCT00260065
Conditions: Myelodysplastic Syndrome
Keywords: Myelodysplastic Syndrome Decitabine Dacogen MGI Pharma
Sponsor: Eisai Inc.
Start date: 2005-05-01; Completion date: 2008-12-01
Enrollment: 99 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the overall response rate in patients with myelodysplastic syndromes (MDS) given a daily dosing schedule of decitabine.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Decitabine
Intervention descriptions: intervention 1: 20mg/m\^2, IV on days 1-5 of each 28 day cycle; until progression, death or unacceptable toxicity develops.

Protocol documents: