ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00080938
Conditions: Lung Cancer Metastatic Cancer
Keywords: recurrent non-small cell lung cancer stage IV non-small cell lung cancer squamous cell lung cancer adenocarcinoma of the lung large cell lung cancer bronchoalveolar cell lung cancer adenosquamous cell lung cancer tumors metastatic to brain
Sponsor: Eastern Cooperative Oncology Group
Start date: 2005-12-20; Completion date: 2009-02-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Radiation therapy uses high-energy x-rays to damage tumor cells. Drugs such as temozolomide may make the tumor cells more sensitive to radiation therapy. Combining temozolomide with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving temozolomide together with whole-brain radiation therapy works in treating patients with brain metastasis secondary to non-small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the intracranial response rate in patients with brain metastasis secondary to non-small cell lung cancer treated with whole brain radiotherapy and temozolomide.

Secondary

* Determine the time to radiological progression in patients treated with this regimen.
* Determine the time to neurological progression (confirmed by magnetic resonance imaging (MRI)) in patients treated with this regimen.
* Determine the overall survival of patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: This is a multicenter study.

Patients undergo whole brain radiotherapy once daily, 5 days a week, for 2 weeks (10 fractions). Patients also receive concurrent oral temozolomide once daily on days 1-14.

Beginning 3 weeks after the completion of chemoradiotherapy, patients receive oral temozolomide once daily on days 1-5. Treatment repeats every 28 days for up to 6 courses in the absence of neurologic (Central Nervous System, CNS) progression or unacceptable toxicity.

Patients were followed every 3 months for 2 years.

ACCRUAL: A total of 26 patients were accrued for this study.

Arms: arm 1: Temozolomide:administered orally. Radiation: whole brain radiation therapy
Interventions: intervention 1: Temozolomide intervention 2: Radiation therapy
Intervention descriptions: intervention 1: Temozolomide (TMZ) to be given at a dose of 75 mg/m2/day for 14 days, starting on D1 of whole brain radiotherapy (WBRT). Three weeks after completion of WBRT, TMZ will be given at a dose of 200 mg/m2/day x 5 days (or 150 mg/m2/day if prior chemotherapy) every 28-days,for an additional two cycles. intervention 2: Standard whole brain radiation therapy 30 Gy in ten fractions.

Protocol documents:
Clinical trial NCT00093847
Conditions: Depression
Keywords: Selective Serotonin Reuptake Inhibitors S-adenosyl Methionine SSRI SAMe
Sponsor: Massachusetts General Hospital
Start date: 2004-05-01; Completion date: 2009-02-01
Enrollment: 73 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine the effectiveness of adding S-adenosyl methionine to antidepressant drug treatment in reducing depressive symptoms in depressed people who have not responded to antidepressants alone.

Detailed description:
Some people with depression do not respond well to antidepressant treatment. S-adenosyl methionine (SAMe) is a naturally occurring compound that may have antidepressant effects. SAMe may also enhance the effectiveness of other antidepressants, such as selective serotonin reuptake inhibitors (SSRIs). This study will determine the effectiveness of oral SAMe in enhancing the effects of SSRIs in patients currently not responding to SSRI treatment.

This study will last 6 weeks. No follow-up visits will occur. Participants will be randomly assigned to add either oral SAMe or placebo to their existing SSRI regimen for 6 weeks. Depression scales and self-report questionnaires regarding depressive symptoms will be used to assess participants at the end of the study.

Arms: arm 1: Participants receiving the oral SAMe tosylate arm 2: Participants receiving placebo
Interventions: intervention 1: S-adenosyl methione (SAMe) intervention 2: Placebo
Intervention descriptions: intervention 1: Oral SAMe tosylate, up to 1600 mg per day for 6 weeks intervention 2: Placebo to be taken daily for 6 weeks

Protocol documents:
Clinical trial NCT00095212
Conditions: HIV Infection
Keywords: HIV women androgen Treatment Experienced
Sponsor: Massachusetts General Hospital
Start date: 2004-09-01; Completion date: 2009-02-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Androgen deficiency in HIV-infected women is associated with sarcopenia and may cause critical reductions in physical functioning and reduced bone density. The effects of long-term androgen therapy on lean body mass, bone density and other clinical endpoints including quality of life, functional status and neurocognitive function in HIV-infected women are not known.

Detailed description:
We will perform an 18-month randomized, double-blinded, placebo-controlled study among relatively androgen deficient women with HIV, to determine the effects of testosterone administration on lean body mass. The administered dose will be 300 micrograms twice a week vs. identical placebo in the form of a transdermal preparation. Secondary endpoints include effects on bone density, quality of life, neurocognitive function and menstrual function. Open label administration at 300 micrograms twice a week will be initiated for 12 months in all subjects following the randomized portion of the study. Assuming a 15% dropout rate and 25 randomized patients, the probability is 80 percent that the study will detect a treatment difference at a two sided 5.000 percent significance level, if the true difference between the treatments is 2.7 kg. This is based on the assumption that the standard deviation of the response variable, lean body mass by DEXA, is 2.3 kg, as was shown by Choi et al1 over 12 weeks in HIV-infected women at the same dose of 300 ug 2x/week.

Arms: arm 1: 300 micrograms applied twice a week arm 2: placebo patch (0 micrograms of testosterone)applied twice a week
Interventions: intervention 1: 1 Transdermal Testosterone (Patch) intervention 2: 2 Placebo Patch
Intervention descriptions: intervention 1: 300 micrograms twice a week intervention 2: Placebo patch (0 micrograms of testosterone) applied twice a week

Protocol documents:
Clinical trial NCT00122382
Conditions: Rheumatoid Arthritis
Keywords: abatacept, methotrexate, erosive RA
Sponsor: Bristol-Myers Squibb
Start date: 2005-07-01; Completion date: 2009-02-01
Enrollment: 1052 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a world wide study to evaluate the remission and joint damage in subjects treated with abatacept in addition to methotrexate versus subjects who receive methotrexate along with a placebo.

Detailed description:

Arms: arm 1: abatacept 10 mg/kg intravenous (IV) + methotrexate arm 2: placebo IV + methotrexate
Interventions: intervention 1: Abatacept intervention 2: placebo intervention 3: methotrexate
Intervention descriptions: intervention 1: abatacept 10 mg/kg IV monthly, methotrexate weekly, for 24 months intervention 2: placebo IV, monthly, methotrexate weekly for 12 months followed by abatacept 10 mg/kg IV monthly, methotrexate weekly for 12 months intervention 3: Oral, titrated to at least 15 mg per week not to exceed 20 mg per week administered every 28 days from Month 12 to Month 24

Protocol documents:
Clinical trial NCT00141726
Conditions: Lung Injury, Acute Respiratory Distress Syndrome, Adult Bronchiolitis Obliterans
Keywords: Enbrel Stem Cell Transplantation Lung Injury
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2003-10-01; Completion date: 2009-02-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine the effectiveness of etanercept in the treatment of patients with sub-acute lung injury following a bone marrow transplant. This study will also examine the toxicity of treatment with etanercept as well as whether there is an improved quality of life in these patients.

Detailed description:
Lung or breathing problems can develop several months to years following a bone marrow transplant. In some cases, these breathing problems develop without any signs of germs or infection in the lungs. The name for this type of breathing problem is called "Sub-Acute Lung Injury". Sub-acute lung injury often develops many months, even years following a bone marrow transplant. It is often characterized by shortness of breath, cough, wheezing and fatigue.

Sub-acute lung injury can either lead to the formation of scar tissue in the lungs (making it difficult to take deep breaths), or it can cause the lungs to get weak (making people feel out of breath easily). Approximately 25 - 50% of patients with sub-acute lung injury may eventually die from the damage in their lungs. Typically, such patients die from infections that develop inside the damaged lungs.

In this study, treatment with an experimental drug called Etanercept will be used. (Enbrel). The physicians feel there is the possibility that Etanercept may help improve breathing. Breathing ability will be assessed prior to treatment as well as during and after treatment so that comparisons can be made.

Arms: arm 1: Etanercept for lung injury
Interventions: intervention 1: Etanercept
Intervention descriptions: intervention 1: Etanercept will be given on an open label, single arm basis to patients with non-infectious, sub-acute lung injury. 0.4 mg/kg/dose to a maximum of 25 mg, subcutaneously, twice weekly, for a total of 24 dosages.

Protocol documents:
Clinical trial NCT00158223
Conditions: Schizophrenia Psychotic Disorders
Keywords: Schizophrenia Clozapine Treatment Combination Unresponsive Schizoaffective Disorders
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2004-10-01; Completion date: 2009-02-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.

Detailed description:
A significant number of schizophrenics exhibit partial or no response to typical antipsychotic medications. Clozapine has been shown to be more effective in treating schizophrenia than typical antipsychotic drugs. However, only an estimated 30% to 60% of people who are unresponsive to treatment with typical antipsychotics will respond to treatment with clozapine. Taking clozapine with pimozide, an antipsychotic drug, can increase clozapine's effects. However, sufficient research on this approach has not yet been performed. This study will assess the effectiveness of pimozide in enhancing the effects of clozapine in the treatment of schizophrenia.

Participants in this double-blind study will receive a stable dose of clozapine for eight weeks prior to enrollment. For the first 4 weeks following enrollment, baseline measurements will be taken. Once a week, participants will report to the study site, where symptom severity, cognitive ability, and functional status, including reading level, will be assessed. In addition, participants will receive a standard medical examination, which will include blood tests and an EKG. Upon completion of this initial phase, participants will be randomly assigned to one of two treatment groups: clozapine combined with pimozide; or clozapine combined with placebo. This phase will last for 12 weeks. Study visits will continue to occur weekly, and will be used to re-assess the measurements obtained during baseline. In addition, participants will have an EKG at each study visit for the first 4 weeks of treatment. All baseline measurements will be repeated in Week 12.

Arms: arm 1: Participants will receive encapsulated placebo made to match active drug arm 2: Participants will receive pimozide flexible dosing
Interventions: intervention 1: Pimozide intervention 2: Placebo
Intervention descriptions: intervention 1: Each capsule of active treatment will contain 2 mg of pimozide. Dosing will be flexible and will range from a minimum of 2 mg per day to 8 mg per day. Dosing will begin at Week 1 with 1 capsule per day. This will be slowly titrated at a rate of 1 capsule per week to a maximum of 4 capsules depending upon clinical response and side effects. intervention 2: Active drug and placebo will be encapsulated in an identical fashion. The placebo capsule will be made to match in appearance and weight. There will be flexible dosing, allowing a minimum of 1 capsule per day to 4 capsules per day, in order to match the dosing range of the active treatment.

Protocol documents:
Clinical trial NCT00160199
Conditions: Secondary Amenorrhea
Keywords: To collect additional data on 300 and 400 mg doses of PROMETRIUM in women with secondary amenorrhea
Sponsor: Solvay Pharmaceuticals
Start date: 2004-11-01; Completion date: 2009-02-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy and safety of 300 mg and 400 mg doses of PROMETRIUM® capsules in women of reproductive age with secondary amenorrhea

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PROMETRIUM® 300 mg intervention 2: PROMETRIUM® 400 mg
Intervention descriptions: intervention 1: 300 mg (3x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles intervention 2: 400 mg (4x100mg capsules) by mouth once daily at bedtime for 10 days X 3 cycles

Protocol documents:
Clinical trial NCT00191139
Conditions: Non-small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2003-03-01; Completion date: 2009-02-01
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To assess the 2 year survival of patients with Stage III unresectable non-small cell lung cancer receiving consolidation gemcitabine or gemcitabine plus docetaxel following concurrent chemotherapy and radiation.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: gemcitabine intervention 2: docetaxel intervention 3: cisplatin intervention 4: etoposide intervention 5: radiation therapy
Intervention descriptions: intervention 1: After induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In both treatment arms, gemcitabine 1000 milligrams per meter squared (mg/m2), is administered intravenously (IV), on days 1 and 8 of every 21-day cycle for 3 cycles. intervention 2: Following cisplatin-etoposide induction chemotherapy, radiation therapy and 10 weeks with no disease progression, randomized consolidation treatment begins. In this treatment arm, docetaxel 75 mg/m2, is administered IV on day 1 of each 21-day cycle for 3 cycles. Docetaxel is given after gemcitabine. intervention 3: As part of induction chemotherapy, cisplatin is given 50 mg/m2, IV, day 1, 8, 29 and 36 (spans 2 cycles) intervention 4: As part of induction chemotherapy, etoposide is given 50 mg/m2, IV, days 1-5 and 29-33 (spans 2 cycles) intervention 5: In conjunction with induction chemotherapy, radiation therapy is administered at a dose of 200 centi Gray (cGy) per day, Monday through Friday for 6 weeks

Protocol documents:
Clinical trial NCT00209131
Conditions: Urolithiasis
Keywords: urolithiasis
Sponsor: Emory University
Start date: 2005-04-01; Completion date: 2009-02-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The majority of kidney stones are treated with shock wave lithotripsy (SWL). We are examining if the medication Flomax will result in improved stone passage rates following SWL.

Detailed description:
Placebo blinded study examining the effects of Flomax on stone passage rates following SWL.

Arms: arm 1: Patients on this arm will be given 0.4mg of Flomax to be taken for one month following their shock wave lithotripsy procedure. arm 2: Patients on this arm will be given a sugar pill to be taken for one month following their shock wave lithotripsy procedure.
Interventions: intervention 1: Flomax intervention 2: Sugar pill
Intervention descriptions: intervention 1: 0.4mg Flomax pills will be given to patients to take once daily for one month following shock wave lithotripsy to aid the stone passage. intervention 2: Comparable sugar pills will be given to the placebo group to take daily for one month following shock wave lithotripsy to aid stone passage.

Protocol documents:
Clinical trial NCT00226941
Conditions: Rectal Cancer Colo-rectal Cancer
Sponsor: George Albert Fisher
Start date: 2004-06-01; Completion date: 2009-02-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The objectives of this study are to:

1. To assess dose-limiting toxicities (DLTs) of capecitabine +/- oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
2. To determine the maximum-tolerated dose (MTD) when capecitabine

   * oxaliplatin in a combination regimen with capecitabine and radiotherapy (Phase 1)
3. To determine the pathologic response rate of cetuximab +/- oxaliplatin in combination with capecitabine and radiotherapy (Phase 2)

Detailed description:
Part of the treatment plan for this study is surgical removal of the tumor that is planned to occur 6 to 8 weeks after completion of radiotherapy (XRT). This study consists of 2 distinct phases (Phase 1 and Phase 2).

In Phase 1, the objectives are to

1. Assess dose-limiting toxicities (DLTs) and
2. Determine a maximum-tolerated dose (MTD)

The Phase 1 endpoints are assessed on an initial cohort of patients after the completion of the chemo-radiotherapy regimen at defined timepoints that precede surgery.

Phase 2 is the efficacy assessment portion of this study. In Phase 2, the objective is to accrue an expansion cohort. Efficacy assessments for phase 2 are to be assessed across all study participants at the time of, or after, surgery, as measured by the pathologic response rate; downstaging; and survival at 5 years from the start of treatment.

Arms: arm 1: * Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 100 mg/m², Days 2 and 23 arm 2: * Cetuximab 250 mg/m² / week
* Capecitabine 700 mg/m²
* Radiotherapy (XRT)
* Oxaliplatin 85 mg/m², Days 2 and 23 arm 3: * Cetuximab 250 mg/m² / week
* Capecitabine 800 mg/m²
* Radiotherapy (XRT) arm 4: * Cetuximab 250 mg/m² / week
* Capecitabine 1000 mg/m²
* Radiotherapy (XRT)
Interventions: intervention 1: Cetuximab intervention 2: Oxaliplatin intervention 3: Capecitabine intervention 4: Radiotherapy intervention 5: Diphenhydramine hydrochloride (HCl)
Intervention descriptions: intervention 1: Cetuximab is a chimeric anti-epidermal growth factor receptor (anti-EGFR) monoclonal antibody, administered via a intravenous (IV) infusion at 400 mg/m² (initial loading dose) or 250 mg/m² (weekly dose). Dosage is based on m² of body surface area (BSA) intervention 2: Oxaliplatin is a cancer medication used to treat colorectal cancer, and is administered on Days 2 and 23. intervention 3: Capecitabine is a cancer medication, and is administered based on m² of body surface area (BSA) delivered in equivalent morning and evening doses intervention 4: Radiotherapy is administered on weekdays in 180 centigray fractions ("doses"), for 28 total fractions delivering a total dose of 5040 centigray (cGy) intervention 5: Diphenhydramine HCl 50 mg (or equivalent) is administered as a per-medication for cetuximab

Protocol documents:
Clinical trial NCT00243412
Conditions: Rheumatoid Arthritis
Keywords: Rituxan RA
Sponsor: Genentech, Inc.
Start date: 2005-08-01; Completion date: 2009-02-01
Enrollment: 42 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a Phase II, randomized, double-blind, multicenter study designed to evaluate the safety and efficacy of rituximab, administered at two different regimens for 2 years, in patients with moderate to severe active rheumatoid arthritis (RA) receiving stable doses of methotrexate (MTX).

Detailed description:

Arms: arm 1: Rituximab: 1000 mg intravenous (IV) on Days 1 and 15 of the first cycle; 500 mg IV on Days 1 and 15 of each subsequent 6-month cycle (Months 6, 12, and 18).

Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion.

Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant).

Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk). arm 2: Rituximab: 1000 mg IV on Days 1 and 15 of each 12-month cycle (Rituximab cycles were administered at baseline and Month 12.) For the Month 6 and 18 cycles, rituximab or placebo was administered.

Corticosteroids: 100 mg IV methylprednisolone prior to each rituximab infusion For the Months 6 and 18 cycles, IV saline was administered prior to each rituximab or placebo infusion.

Methotrexate: 15-25 mg/wk oral or parenteral (10-14 mg/wk if intolerant).

Folate: Minimum of 1 mg/day (or folinic acid 5 mg/wk).
Interventions: intervention 1: folate intervention 2: methotrexate intervention 3: methylprednisolone intervention 4: Placebo intervention 5: Rituximab
Intervention descriptions: intervention 1: Minimum of 1 mg/day oral (or folinic acid 5 mg/week) intervention 2: 15-25 mg/week oral or parenteral (10-14 mg/week if intolerant) intervention 3: 100 mg intravenous (IV) prior to each rituximab infusion (For Arm B, for the Months 6 and 18 cycles, IV saline was administered prior to each placebo infusion) intervention 4: To maintain the blind, patients in Arm B (Rituximab 1000 mg) received placebo infusions at Months 6 and 18. intervention 5: 500 mg or 1000 mg IV\*2.

Protocol documents:
Clinical trial NCT00247676
Conditions: Liver Neoplasms Unresectable Hepatocellular Carcinoma
Keywords: Liver neoplasms, sunitinib, Phase 2
Sponsor: Pfizer
Start date: 2006-02-01; Completion date: 2009-02-01
Enrollment: 37 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study will consist of two parts. In Part 1 the study will start enrolling 38 patients and then further 25 patients up to a total of 63 eligible patients. If the study gives good results it can be expanded to a total of 160 patients. SU011248 will be administered orally daily for 4 weeks followed by a 2-week rest at a starting dose of 50 mg \[milligrams\] with provision for dose reduction based on tolerability. All patients will receive repeated cycles of SU011248 until disease progression, occurrence of unacceptable toxicity, or other withdrawal criteria are met. After discontinuation of treatment, patients will be followed up in order to collect information on further antineoplastic therapy and survival

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Sunitinib (SU011248)
Intervention descriptions: intervention 1: Sunitinib 50 mg by oral capsule, daily for 4 weeks in every 6 week cycle until progression or unacceptable toxicity.

Protocol documents: