ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00140426
Conditions: Anorexia Nervosa
Keywords: Anorexia Nervosa Risperidone Atypical Neuroleptics Dopamine Leptin Body Image Adolescents
Sponsor: University of Colorado, Denver
Start date: 2004-08-01; Completion date: 2009-12-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this pilot study is to determine the safety and efficacy of risperidone for the treatment of anorexia nervosa.

Hypothesis 1: Subjects on risperidone will show a more significant decrease in body image distortion and Eating Disorder Inventory -2 scores than subjects on placebo.

Hypothesis 2: Subjects on risperidone will reach and maintain at or above 90% Ideal body weight sooner than controls.

Detailed description:
The lack of effective medications for the symptoms of anorexia nervosa (AN), combined with early promising findings in case reports (Risperidone and Olanzapine) and one open study of olanzapine have led to increased use of these medications for individuals with AN. This double-blind placebo controlled study of risperidone will attempt to determine if risperidone is effective in decreasing core symptoms of anorexia nervosa and decreasing the length of time required to reach and maintain at or about 90% Ideal body weight. The safety of risperidone in this population will also be examined through monitoring of Extrapyramidal Symptoms, Tardive Dyskinesia, Electrocardiograms's, Resting Energy Expenditure, liver enzymes and other blood chemistry. Other possible variables which may mediate the recovery process or be impacted by risperidone,such as leptin and anxiety symptoms are also being measured.

Arms: arm 1: double blind study of risperidone for anorexia nervosa. this is the subject group that receives placebo. arm 2: Study is double blind, placebo controlled. This is the subject group on active medication
Interventions: intervention 1: Risperidone intervention 2: Placebo
Intervention descriptions: intervention 1: risperidone titrated 0.5 to 4 mg over study enrollment. Mean Length of Phase 1 is currently 10 weeks. intervention 2: Comparison of risperidone versus placebo for the treatment of symptoms related to anorexia nervosa.

Protocol documents:
Clinical trial NCT00147966
Conditions: Rheumatoid Arthritis
Keywords: active disease despite concomitant methotrexate
Sponsor: University of California, San Diego
Start date: 2008-06-01; Completion date: 2009-12-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur as a result of treatment with rituximab.

Detailed description:
Using repeated arthroscopic biopsies of patients with rheumatoid arthritis, the researchers will assess changes in the immune response that occur after treatment with rituximab.

Arms: arm 1: all patients get treatment
Interventions: intervention 1: rituximab
Intervention descriptions: intervention 1: treatment with rituximab

Protocol documents:
Clinical trial NCT00185588
Conditions: Pancreatic Cancer
Sponsor: George Albert Fisher
Start date: 2004-10-01; Completion date: 2009-12-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine the optimal safe and tolerable dose of gemcitabine in combination with once daily or twice daily dose of PTK/ZK in patients with unresectable pancreatic cancer. The Phase II part of this study planned to determine the antitumor activity of this regimen and its effectiveness of preventing tumor growth and spread.

Detailed description:

Arms: arm 1: Gemcitabine 700 mg/m2 + vatalanib 1250 mg daily arm 2: Gemcitabine 850 mg/m2 + vatalanib 1250 mg arm 3: Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter arm 4: Gemcitabine 850 mg/m2 + vatalanib 250 mg Q12 hours x 1 week then 500 mg Q12 hours thereafter
Interventions: intervention 1: Vatalanib intervention 2: Gemcitabine
Intervention descriptions: intervention 1: Vatalanib 250 mg PO Q12 hours x 7 days, 8th day forward 500 mg PO Q12 hours intervention 2: 850 mg/m2

Protocol documents:
Clinical trial NCT00193453
Conditions: Lung Cancer
Keywords: Lung Cancer
Sponsor: SCRI Development Innovations, LLC
Start date: 2005-07-01; Completion date: 2009-12-01
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This purpose of this study is to evaluate the role of gemcitabine and docetaxel, a well tolerated chemotherapy regimen in the treatment of advanced non-small cell lung cancer (NSCLC), in combination with a novel agent cetuximab.

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

* Docetaxel + Gemcitabine + Cetuximab

Arms: arm 1: Newly-diagnosed unresectable stage III/IV NSCLC patients were treated with docetaxel-30mg/m2 IV; gemcitabine-1000mg/m2 IV days 1, 8; cetuximab-400mg/m2 IV day 1, then 250 mg/m2 IV weekly. Patients received up to 6 cycles (21-d).
Interventions: intervention 1: Gemcitabine intervention 2: Docetaxel intervention 3: Cetuximab
Intervention descriptions: intervention 1: 1000mg/m2 30min IV, Day 1 \& 8 intervention 2: 30mg/m2, 30min IV, day 1 \& 8 intervention 3: 100mg/m2 IV, Cycle 1 Day 1, 250mg/m2 IV day 8 \& 15, all subsequent cycles 250mg/m2 IV day 1, 8, \& 15

Protocol documents:
Clinical trial NCT00205179
Conditions: Alzheimer's Disease
Sponsor: University of Wisconsin, Madison
Start date: 2005-01-01; Completion date: 2009-12-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this pilot study is to evaluate the potential effects of soy isoflavone supplements on cognitive function for men and women with Alzheimer's Disease (AD). Preliminary studies evaluating the effects of soy supplements on memory in cognitively healthy older adults have yielded promising results that are now being evaluated in patients with AD. It is hypothesized that isoflavone supplements will ameliorate cognitive declines for older adults diagnosed with Alzheimer's disease, when compared to subjects on placebo.

Detailed description:

Arms: arm 1: 100mg/day soy isoflavones arm 2: 100mg/day matching placebo
Interventions: intervention 1: Novasoy intervention 2: Placebo
Intervention descriptions: intervention 1: 100mg/day soy isoflavones intervention 2: 100mg/day matching placebo

Protocol documents:
Clinical trial NCT00217971
Conditions: Marijuana Abuse
Keywords: cannabis dependence dronabinol treatment
Sponsor: New York State Psychiatric Institute
Start date: 2005-03-01; Completion date: 2009-12-01
Enrollment: 156 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if dronabinol decreases the symptoms of marijuana addiction and withdrawal.

Detailed description:
Marijuana addiction is associated with significant withdrawal symptoms, including anxiety, irritability, bodily discomfort, and insomnia. The purpose of this study is to determine the effectiveness of dronabinol in reducing withdrawal symptoms.

During this twelve-week, double-blind, placebo-controlled study, study visits will occur twice each week. During study visits, participants will receive either placebo or medication. Throughout the study, all participants will receive individualized psychotherapy sessions. At each study visit, vital signs, self-report ratings, and urine samples will be collected. Participants will have a follow-up evaluation at month 6.

Arms: arm 1: Dronabinol: 20mg bid for a daily maximum dose of 40mg. arm 2: placebo
Interventions: intervention 1: Dronabinol intervention 2: Placebo
Intervention descriptions: intervention 1: Dronabinol intervention 2: placebo

Protocol documents:
Clinical trial NCT00240981
Conditions: Sarcopenia Hypogonadism Muscular Diseases
Keywords: Andropause frailty hormone replacement therapy Aging
Sponsor: Boston Medical Center
Start date: 2005-01-01; Completion date: 2009-12-01
Enrollment: 209 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether testosterone replacement in older men with low testosterone levels will increase muscle strength, improve physical performance and overall sense of well being, and reduce fatigue.

Detailed description:
The primary objective of this study is to determine whether testosterone replacement in older men, who have low testosterone levels and mild to moderate physical impairment, will increase their maximal voluntary muscle strength of major upper and lower extremity muscle groups. The second objective is to determine whether testosterone replacement will improve the power of knee extension, physical performance tests, the level of physical activity (measured by 3D accelerometer), self-reported disability, exercise tolerance and mobility. The third objective is to determine whether testosterone supplementation improves fatigue, affect, and overall sense of well being in older men with low testosterone levels. A fourth objective is to define the Minimum Clinically Important Differences in physical measures perceived by the participants (MCID).

Participant involvement will require 15-17 clinic visits over 28 weeks. Five to 7 of these visits are for physical testing, including body composition, muscle performance, and physical function. Throughout the study, hormone measurements will be obtained.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Topical testosterone gel 1% (active formulation) intervention 2: Topical gel (placebo formulation)
Intervention descriptions: intervention 1: Starting dose 10 g/day; increased to 15 g/day or decreased to 5 g/day in order to attain morning total testosterone level between 500 - 1000 ng/dL. Blinding achieved by combining a total of 3 tubes of active or placebo gel, applied to upper arms and shoulders each day. intervention 2: Starting dose 15 g/day (3 tubes), applied to upper arms and shoulders each day.

Protocol documents:
Clinical trial NCT00258362
Conditions: Endometrial Cancer
Keywords: recurrent endometrial carcinoma stage III endometrial carcinoma stage IV endometrial carcinoma
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2005-07-01; Completion date: 2009-12-01
Enrollment: 41 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as carboplatin and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy together with radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin and docetaxel followed by radiation therapy works in treating patients with stage III, stage IV, or recurrent endometrial cancer.

Detailed description:
OBJECTIVES:

Primary

* Determine the time to progression in patients with stage III or IV or recurrent endometrial cancer treated with induction chemotherapy comprising carboplatin and docetaxel followed by radiotherapy and consolidation chemotherapy comprising carboplatin and docetaxel.

Secondary

* Determine the toxic effects of this regimen in these patients.
* Determine the overall survival of patients treated with this regimen.

OUTLINE: Patients receive docetaxel intravenous (IV) over 1 hour and carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 3 courses. After hematologic recovery from chemotherapy, patients receive radiotherapy 5 days a week for up to 7 weeks. Beginning 3-4 weeks later, patients receive another 3 courses of docetaxel and carboplatin.

After completion of study treatment, patients are followed periodically for 2 years.

Arms: arm 1: Patients with advanced or current endometrial cancer receiving treatment with induction docetaxel/carboplatin, radiation (Weekly, 5 days/week over 6-7 weeks, tailored 4500 cGy) and followed by 3 courses of consolidation docetaxel (75 mg/m\^2 on Day 1 of each course) /carboplatin (Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles).
Interventions: intervention 1: carboplatin intervention 2: docetaxel intervention 3: radiation therapy
Intervention descriptions: intervention 1: Dose = Area-under-the-curve 6 on Day 1 every 3 weeks for 3 cycles. intervention 2: 75 mg/m\^2 on Day 1 of each course intervention 3: Weekly, 5 days/week over 6-7 weeks (tailored 4500 cGy)

Protocol documents:
Clinical trial NCT00268892
Conditions: Prostate Cancer
Keywords: Prostate Cancer Androgen ablation therapy
Sponsor: Ferring Pharmaceuticals
Start date: 2006-01-01; Completion date: 2009-12-01
Enrollment: 278 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this extension study was to collect long-term safety and tolerability information to support a marketing authorisation application for a three-month dosage regimen of degarelix.

Detailed description:
The data include data from the participants who participated in both the main study FE200486 CS15 (NCT00113753) and the extension study FE200486 CS15A.

Arms: arm 1: Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (40 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (40 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). arm 2: Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 3, 6, and 9) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL). arm 3: Participants in this arm who completed the main study continued with the same dose (240 mg (40 mg/mL) starting dose and 240 mg (60 mg/mL) at months 1, 4, 7, 10) in the extension study (240 mg (60 mg/mL) every three months). A protocol amendment in June 2006 changed the dosage to 360 mg or 480 mg (60 mg/mL).
Interventions: intervention 1: Degarelix intervention 2: Degarelix intervention 3: Degarelix
Intervention descriptions: intervention 1: Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).

Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study. intervention 2: Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).

Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study. intervention 3: Participants who completed the main study initially continued with the same dose in the FE200486 CS15A extension study. A protocol amendment changed the dosage to 360 mg (60 mg/mL) or 480 mg (60 mg/mL).

Drug supplied as a powder to be dissolved in the solvent for solution for injection. Degarelix given by subcutaneous injection every 3 months until the end of the study.

Protocol documents:
Clinical trial NCT00285467
Conditions: Renal Osteodystrophy
Keywords: kidney, parathyroid hormone, vitamin d
Sponsor: Indiana University School of Medicine
Start date: 2006-01-01; Completion date: 2009-12-01
Enrollment: 55 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The majority of patients with moderate to severe chronic kidney disease (CKD) (stages 3 and 4) develop secondary hyperparathyroidism (2°HPT), but the optimal therapy to control hyperparathyroidism in this group is unknown. The National Kidney Foundation presented guidelines in 2003 recommending vitamin D supplementation for vitamin D insufficient patients and active vitamin D therapy in patients with sufficient levels. These guidelines are based on opinion since there are no significant trials to determine if vitamin D supplementation is effective in this population. The active vitamin D metabolites doxercalciferol, paricalcitol, and calcitriol have been shown to effectively suppress parathyroid hormone (PTH), but have not been compared with vitamin D supplementation with a calciferol (ergocalciferol or cholecalciferol). Beyond hyperparathyroidism, small studies suggest vitamin D replacement in vitamin D insufficient non-CKD subjects result in improved pain, feeling of well being, blood pressure and strength. In this proposed study we wish to directly compare the effectiveness of cholecalciferol versus doxercalciferol in suppressing elevated PTH levels in subjects with CKD not on dialysis who have vitamin D insufficiency in a three month study. Secondary endpoints will be change in blood pressure.

Detailed description:
Patients with CKD stage 3 were randomly allocated (by blinded group allocation) to either cholecalciferol (4000 U per day for one month then 2000 IU daily thereafter) or doxercalciferol (2.5 mcg po daily. Assessments for blood endpoints (primary end point PTH; secondary calcium, phosphorus) were done monthly. Other assessments (blood pressure) were done at baseline and at 3 months.

Arms: arm 1: doxercalciferol 1 mcg capsule orally daily for 3 months. This is a form of vitamin D that does not require activation by enzymes in the liver and kidney. arm 2: cholecalciferol 4000 IU capsule orally daily for one month, then 2000 IU capsule daily orally for 2 months. this form of vitamin D requires activation by cells of the body.
Interventions: intervention 1: doxercalciferol intervention 2: Cholecalciferol
Intervention descriptions: intervention 1: form of vitamin D that is already in active form. intervention 2: from of vitamin D that requires cells in the body to make active

Protocol documents:
Clinical trial NCT00296335
Conditions: Stomach Cancer
Keywords: Stomach cancer Adjuvant chemotherapy Mitomycin Cisplatin Doxifluridine
Sponsor: Asan Medical Center
Start date: 2002-02-01; Completion date: 2009-12-01
Enrollment: 855 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase III randomized study designed to evaluate the efficacy of mitomycin, doxifluridine, and cisplatin compared to mitomycin and doxifluridine.

Detailed description:
Stomach cancer is the most common cancer in Korea and one of the major health problems worldwide. The most effective treatment for gastric cancer is curative surgical resection of primary tumor. However, a substantial number of patients eventually die of recurrences after curative resection. A number of randomized trials investigating the role of adjuvant chemotherapy have been conducted. However, the efficacy of adjuvant chemotherapy is still controversial and varied between Western and Asian trials. Meta-analysis of Western trials didn't demonstrate the benefit of adjuvant chemotherapy after curative resection. Conversely, some Asian studies have demonstrated the efficacy of adjuvant chemotherapy after curative resection. In a previous study, mitomycin plus tegafur prolonged the survival in resected gastric cancer compared to no treatment.

This study is designed to evaluate the efficacy of mitomycin, cisplatin and prolonged treatment with doxifluridine compared to mitomycin plus doxifluridine.

Arms: arm 1: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84) arm 2: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168)
Interventions: intervention 1: Mitomycin, doxifluridine and cisplatin intervention 2: Mitomycin and doxifluridine
Intervention descriptions: intervention 1: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28- day 336), Cisplatin 60mg/m2 intravenously (day 28, day 56, day 84, day 112, day 140, and day 168) intervention 2: Mitomycin-C 20mg/m2 intravenously (day 1), Doxifluridine 460-600mg/m2/day per oral (day 28-day 84)

Protocol documents:
Clinical trial NCT00299221
Conditions: Immunosuppression
Keywords: immunosuppression steroid withdrawal rejection coronary disease cytomegalovirus infection
Sponsor: Newark Beth Israel Medical Center
Start date: 2004-04-01; Completion date: 2009-12-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This was a study to compare less intense immunosuppression with a more traditional approach. The hypothesis was that less immunosuppression will provide similar protection against rejection than typical 2-3 drug therapy.

Detailed description:
This was a prospective, randomized, controlled (open-label) trial of 2 different strategies of immunosuppression in de novo post-heart transplant patients. The hypothesis was that immunosuppression with tacrolimus and mycophenolate mofetil, coupled with rapid steroid weaning would provide similar anti-rejection efficacy as tacrolimus with only a 2 week course of mycophenolate mofetil but including the same rapid steroid wean.

The primary endpoint was the mean International Society for Heart and Lung Transplantation (ISHLT) biopsy score over the first 6 months post-transplant. Secondary endpoints included the incidence of adverse events over the first year post-transplant, as well as all-cause mortality, 12 month ISHLT biopsy score (mean), along with the incidence of proven cytomegalovirus disease. In addition, the incidence of allograft vasculopathy as assessed by angiography or intravascular ultrasound was compared between groups.

Arms: arm 1: Tacrolimus alone arm 2: tacrolimus with mycophenolate mofetil
Interventions: intervention 1: Tacrolimus intervention 2: combination therapy
Intervention descriptions: intervention 1: tacrolimus intervention 2: MMF

Protocol documents: