ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00767624
Conditions: Sleep Initiation and Maintenance Disorders Depression
Sponsor: Stanford University
Start date: 2008-12-01; Completion date: 2015-06-01
Enrollment: 150 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.

Detailed description:
Participants with major depressive disorder and insomnia who meet all study criteria will receive state-of-the-art antidepressant medications and one of two insomnia therapies. The specific therapy for insomnia will be determined by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or desensitization psychotherapy for insomnia. The study physician will select an initial antidepressant medication from a list of three possible medications . If that medication is not helpful, another medication may be tried after 8 weeks or in the event of severe side effects.

Arms: arm 1: Combined antidepressant medication (determined by an algorithm) plus desensitization therapy arm 2: Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
Interventions: intervention 1: Antidepressant intervention 2: Desensitization Therapy for Insomnia intervention 3: Cognitive Behavioral Therapy for Insomnia
Intervention descriptions: intervention 1: Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00795236
Conditions: Sleep Disorder Blindness
Keywords: melatonin
Sponsor: Oregon Health and Science University
Start date: 2009-11-01; Completion date: 2015-06-01
Enrollment: 13 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to learn more about abnormal body rhythms in blind boys and girls that keep them from falling asleep at bed-time or cause them difficulty staying alert during the day. The investigators hope to learn if there are any differences between the body rhythms of girls and boys. The investigators also want to investigate whether age or puberty have an effect on body rhythms.

Detailed description:
Subjects will be asked to collect saliva samples in their home hourly throughout the daytime, approximately every 2 weeks. Subjects may be monitored for up to a year, after which they will be discontinued from the study. If subjects are found to be naturally entrained to the 24-hour day, they will be monitored longitudinally for changes. Subjects will be discontinued after their monitoring period is over or after an entrained status has been confirmed. While no specific time commitment is required, we hope most subjects will participant for 4 months - 2 years.

Arms: arm 1: Observe to determine free-running versus entrained status. arm 2: Subjects with free-running rhythms will take melatonin.
Interventions: intervention 1: Melatonin
Intervention descriptions: intervention 1: One 0.5 mg tablet of melatonin will be taken by subjects who are free-running and willing to enter the intervention phase of the study. These subjects will take melatonin until entrainment status is confirmed or throughout the duration of the study.

Protocol documents:
Clinical trial NCT00802412
Conditions: Nicotine Dependence Alcohol Dependence
Keywords: tobacco use disorders alcoholism
Sponsor: VA Office of Research and Development
Start date: 2009-01-01; Completion date: 2015-06-01
Enrollment: 132 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether topiramate is effective as an aid to smoking cessation for recovering alcohol dependent men.

Detailed description:
This study is a 12-week, double-blind, placebo-controlled trial to test the efficacy of topiramate versus placebo as an aid to smoking cessation for recovering alcohol dependent men. Another aim of the study is to explore whether or not topiramate reduces relapse to alcohol use in patients with comorbid alcohol and nicotine dependence. All participants will receive a standardized psychosocial intervention in combination with the medication (or placebo). Following completion of the treatment phase of the study, participants will enter a 24-week follow-up period during which the longer-term outcome of the intervention will be assessed.

Arms: arm 1: The subjects for the proposed study will be 180 currently smoking, treatment-seeking male veterans with alcohol and nicotine dependence. Ninety subjects will be randomized to the topiramate arm and 90 subjects will be randomized to the placebo group. arm 2: 90 participants, will receive matching placebo
Interventions: intervention 1: Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: Topiramate will be titrated over 5 weeks to a maximum dosage of 200 mg according to the following schedule: 25mg daily for days 1-7, 50mg daily for days 8-14, 75mg daily for days 15-21, 100mg daily for days 22-28, 150mg daily for days 29-35, 200mg daily for days 36-42. Maximum dosage will be maintained for 6 weeks, followed by a one-week taper-off period (100mg daily for 4 days and 50mg daily for 3 days). intervention 2: Placebo/study medication will be administered in opaque capsules in an identical fashion to maintain the double-blind study design.

Protocol documents:
Clinical trial NCT00811070
Conditions: Chronic Myelogenous Leukemia
Keywords: CML. Chronic myelocytic leukemia. Philadelphia Chromosome. Japanese. SKI-606. Bosutinib. Imatinib resistant. Imatinib intolerant
Sponsor: Pfizer
Start date: 2007-12-01; Completion date: 2015-06-01
Enrollment: 63 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a two-part safety and efficacy study of SKI-606 in subjects who have Philadelphia chromosome positive leukemias (CML). Part 1 will be a dose-escalation study, in which an escalating dose of SKI-606 (Bosutinib), up to 600 mg, will be studied in subjects with imatinib resistant/refractory or imatinib intolerant chronic phase CML. Part 2 will evaluate the safety and efficacy of the maximum tolerated dose (MTD) of SKI-606 (Bosutinib)identified in Part 1 of the study.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: SKI-606 (Bosutinib)
Intervention descriptions: intervention 1: Formulation: 100 mg Capsule for Part 1, 100 mg tablet for Part1 and Part 2.

SKI-606 (Bosutinib) will be taken by mouth with water and food as continuous once-daily dosing.

Protocol documents:
Clinical trial NCT00849251
Conditions: Refractory Multiple Myeloma Stage I Multiple Myeloma Stage II Multiple Myeloma Stage III Multiple Myeloma
Sponsor: University of Washington
Start date: 2008-11-01; Completion date: 2015-06-01
Enrollment: 31 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as pegylated liposomal doxorubicin hydrochloride and cyclophosphamide, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the cancer. Giving pegylated liposomal doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone may kill more cancer cells.

PURPOSE: This phase I/II trial is studying the side effects of giving pegylated liposomal doxorubicin hydrochloride together with bortezomib, cyclophosphamide, and dexamethasone and to see how well it works in treating patients with multiple myeloma

Detailed description:
PRIMARY OBJECTIVES:

I. To determine efficacy of this novel combination in newly diagnosed patients with multiple myeloma.

SECONDARY OBJECTIVES:

I. To determine the toxicity of this novel combination regimen in previously treated patients and newly diagnosed patients with multiple myeloma.

OUTLINE:

Patients receive cyclophosphamide intravenously (IV) or orally (PO) over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.

After completion of treatment, patients are followed up every 3 months for 2 years, then annually up to 5 years.

Arms: arm 1: Patients receive cyclophosphamide IV or PO over 1 hour, bortezomib IV over 3 minutes, and dexamethasone IV or PO on days 1, 8, and 15. Patients also receive pegylated liposomal doxorubicin hydrochloride IV over 1 hour on day 8. Treatment repeats every 28 days for up to 4 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: cyclophosphamide intervention 2: pegylated liposomal doxorubicin hydrochloride intervention 3: bortezomib intervention 4: dexamethasone
Intervention descriptions: intervention 1: Given IV or PO intervention 2: Given IV intervention 3: Given IV intervention 4: Given IV or PO

Protocol documents:
Clinical trial NCT00878995
Conditions: Cachexia Squamous Cell Carcinoma
Keywords: stage IIB cervical cancer stage III cervical cancer recurrent cervical cancer cachexia advanced head/neck carcinoma recurrent head/neck carcinoma
Sponsor: The University of Texas Medical Branch, Galveston
Start date: 2009-06-03; Completion date: 2015-06-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
RATIONALE: Testosterone may lessen weight loss and improve muscle size and strength in patients with cachexia caused by cancer.

PURPOSE: This randomized phase I trial is studying whether testosterone administered during standard of care chemotherapy and/or radiation works by helping patients with squamous cell carcinoma to maintain their body weight and muscle size and strength during treatment.

Detailed description:
OBJECTIVES:

* To determine the effect of testosterone therapy on lean body mass and muscle strength in patients with advanced or recurrent squamous cell carcinoma.
* To determine the testosterone therapy on inflammatory biomarkers in patients with advanced or recurrent squamous cell carcinoma.

OUTLINE: Patients are stratified according to age and disease stage. Patients are randomized to 1 of 2 treatment arms.

* Arm I: Patients receive standard of care chemotherapy and/or radiation and placebo testosterone intramuscularly (IM) weekly for 7 weeks.
* Arm II: Patients receive standard of care chemotherapy and/or radiation and testosterone IM weekly for 7 weeks.

Patients undergo dual energy x-ray absorptiometry, muscle strength tests, stable isotope metabolic studies, indirect calorimetry studies, and assessment of their physical activity level, and nutritional counseling. Patients also complete mood, fatigue, and quality-of-life questionnaires.

Blood, muscle tissue, and urine samples are collected periodically for laboratory studies. Samples are analyzed for serum inflammatory biomarkers and inflammatory cytokines by immunoassay.

After completion of study treatment, patients are followed periodically for 1 year.

Arms: arm 1: Patients receive standard of care chemotherapy and/or radiation plus placebo testosterone intramuscularly (IM) weekly for 7 weeks. arm 2: Patients receive standard of care chemotherapy and/or radiation plus testosterone (Testosterone Enanthate 100mg/ml) intramuscularly (IM) weekly for 7 weeks.
Interventions: intervention 1: Placebo Testosterone intervention 2: Testosterone Enanthate 100 MG/ML
Intervention descriptions: intervention 1: Placebo (Saline) Testosterone given IM once per week. intervention 2: Testosterone Enanthate 100mg/ml given once per week IM.

Protocol documents:
Clinical trial NCT00925054
Conditions: Phenylketonuria
Keywords: PKU PEG PAL BioMarin
Sponsor: BioMarin Pharmaceutical
Start date: 2009-09-01; Completion date: 2015-06-01
Enrollment: 40 participants; Allocation: NON_RANDOMIZED; Intervention model: SEQUENTIAL

Brief summary:
The purpose of this study is to evaluate whether weekly injections of phenylalanine ammonia lyase (rAvPAL-PEG) can reduce blood phenylalanine concentrations in PKU subjects and whether repeated administration is safe.

Detailed description:
This is a 2 part, Phase 2, open-label dose-finding study in approximately 35 subjects with PKU. Seven dose cohorts are planned, each consisting of 5 subjects. In Part 1, the planned starting dose levels are those tested in PAL 001 (0.001, 0.003, 0.01, 0.03, 0.1, 0.3, and 1.0 mg/kg), provided no dose limiting toxicity was observed in PAL 001. In Parts 1 and 2, study drug will be administered by clinic staff.

Subjects who completed participation in PAL 001 will receive priority to participate in PAL 002. rAvPAL PEG naïve subjects will be enrolled to fill any dose cohort vacancies resulting from subjects who did not complete PAL 001 or who chose not to continue into PAL 002. In addition, if the number of dose cohorts determined in PAL 001 is less than 7, additional naïve subjects may be added to the existing dose cohorts to provide a total of approximately 35 subjects entering Part 1 of PAL 002. Furthermore, if serial dosing of cohorts in Part 1 of PAL 002 is stopped, additional subjects (either naïve subjects or PAL 001 subjects) may be added to the existing cohorts so that total study enrollment is approximately 35 subjects. In any of these cases, additional subjects will be enrolled sequentially from lowest to highest dose cohort.

Diet will not be altered during the course of this study, except as necessary for safety.

Subjects will be evaluated for safety and for blood Phe concentrations throughout the study. Toxicity will be measured according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE), version 3.

A Data Monitoring Committee will monitor the study.

Arms: arm 1: Subjects will start on rAvPAL-PEG 0.001 mg/kg arm 2: Subjects will start on rAvPAL-PEG 0.003 mg/kg arm 3: Subjects will start on rAvPAL-PEG 0.01 mg/kg arm 4: Subjects will start on rAvPAL-PEG 0.03 mg/kg arm 5: Subjects will start on rAvPAL-PEG 0.1 mg/kg
Interventions: intervention 1: rAvPAL-PEG 0.001 mg/kg intervention 2: rAvPAL-PEG 0.003 mg/kg intervention 3: rAvPAL-PEG 0.01 mg/kg intervention 4: rAvPAL-PEG 0.03 mg/kg intervention 5: rAvPAL-PEG 0.1 mg/kg
Intervention descriptions: intervention 1: In Part 1, the planned starting dose levels is 0.001 mg/kg intervention 2: In Part 1, the planned starting dose levels is 0.003 mg/kg intervention 3: In Part 1, the planned starting dose levels is 0.01 mg/kg intervention 4: In Part 1, the planned starting dose levels is 0.03 mg/kg intervention 5: In Part 1, the planned starting dose levels is 0.1 mg/kg

Protocol documents:
Clinical trial NCT00926588
Conditions: Pain
Keywords: Pain Telecare Collaborative care
Sponsor: US Department of Veterans Affairs
Start date: 2009-10-01; Completion date: 2015-06-01
Enrollment: 250 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Pain is the most common physical symptom in primary care, accounting for an enormous burden in terms of patient suffering, quality of life, work and social disability, and health care and societal costs. Pain is particularly prevalent among veterans. Four major barriers to optimal care include underdetection of pain, inadequate initial treatment, failure to monitor adherence and symptom response, and failure to adjust treatment in patients not responding or intolerant of initial therapy. Therefore, we propose to conduct the Stepped Care to Optimize Pain care Effectiveness (SCOPE) study, a randomized clinical effectiveness trial in primary care.

Detailed description:
SCOPE will enroll 250 primary care veterans with persistent (3 months or longer) musculoskeletal pain of moderate severity, and randomize them to either the stepped care intervention or usual care control group. The intervention will be based upon the empirically-validated Three-Component Model which in SCOPE will involve collaboration between the primary care physician, a nurse pain care manager, and a supervising physician pain specialist. SCOPE will involve a telemedicine approach coupling automated home-based symptom monitoring with telephone-based nurse care management. The intervention will consist of optimized analgesic management using a stepped care approach to drug selection, symptom monitoring, dose adjustment, and switching or adding medications. All subjects will undergo comprehensive outcome assessment at baseline, 1, 3, 6 and 12 months by interviewers blinded to treatment group. Our principal aim is to test whether SCOPE is more effective than usual care in reducing pain as measured by the Brief Pain Inventory. Secondarily, we will test the impact on other pain outcomes (e.g., severity, self-efficacy, use of self-management strategies), emotional functioning, health-related quality of life, and treatment satisfaction.

Arms: arm 1: Patients received automated pain monitoring. A nurse care manager partnering with a physician pain specialist decide on treatment changes collaborating with primary care physicians. Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are used. arm 2: Patients receive usual care for pain from their primary care physician
Interventions: intervention 1: Stepped care
Intervention descriptions: intervention 1: Structured algorithms for stepped care analgesic management and explicit decision rules for adjusting treatment are new tools developed for this study.

Protocol documents:
Clinical trial NCT00958841
Conditions: Pancreatic Neoplasm Pituitary Neoplasm Nelson Syndrome Ectopic ACTH Syndrome
Keywords: Rare tumors of neuroendocrine origin NETs of the pancreatic Pituitary NETs EAS Tumors Nelson's Syndrome Pancreatic neoplasm pituitary neoplasm Nelson Syndrome ectopic ACTH syndrome pasireotide LAR PNETs PiNETS
Sponsor: Novartis Pharmaceuticals
Start date: 2009-09-01; Completion date: 2015-06-01
Enrollment: 118 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess the effectiveness and safety of pasireotide long-acting release in patients who have rare tumors of neuroendocrine origin.

Detailed description:

Arms: arm 1: Patients received pasireotide LAR at 60 mg approximately once every 28 days for 6 months during the core treatment period and additional treatment cycles up to a total of 48 months during the extension phase.
Interventions: intervention 1: pasireotide LAR
Intervention descriptions: intervention 1: Investigational drug pasireotide LAR was supplied in vials with 20 mg or 40 mg powder and 2 mL vehicle was supplied in ampoules for reconstitution.

Protocol documents:
Clinical trial NCT00960115
Conditions: Non-small Cell Lung Cancer
Keywords: NSCLC Stage III EMD531444 L-BLP25 Cyclophosphamide Immunotherapy Tecemotide
Sponsor: Merck KGaA, Darmstadt, Germany
Start date: 2008-12-01; Completion date: 2015-06-01
Enrollment: 178 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase I/II study in Japan to evaluate the safety of EMD531444 and its effects on survival time in patients with stage III unresectable non-small cell lung cancer.

Detailed description:
Phase I part is designed to evaluate the safety of EMD531444 930 microgram (mcg) dose to be used in phase II. Phase II part is designed to be conducted as randomized, double blind, placebo controlled study to compare overall survival time in all randomized subjects.

Arms: arm 1: Active arm 2: Control
Interventions: intervention 1: Tecemotide (L-BLP25) intervention 2: Single low dose cyclophosphamide intervention 3: Placebo intervention 4: Saline
Intervention descriptions: intervention 1: After receiving a single low-dose cyclophosphamide, participants will receive weekly subcutaneous vaccinations with tecemotide (L-BLP25) (930 microgram \[mcg\]) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with tecemotide (L-BLP25) (930 mcg) will be administered every 6 weeks until progressive disease (PD). intervention 2: A single intravenous (IV) infusion of 300 milligram per square meter (mg/m\^2) (to a maximum 600 mg/m\^2) of cyclophosphamide will be administered 3 days prior to tecemotide (L-BLP25), the first vaccine treatment. intervention 3: After receiving single dose of saline, participants will receive weekly subcutaneous vaccinations with placebo that matches with tecemotide (L-BLP25) for 8 weeks, followed by a maintenance treatment phase starting at Week 14, in which subcutaneous vaccinations with placebo will be administered every 6 weeks until PD. intervention 4: A single dose of saline (sodium chloride, 9 grams per liter \[g/L\]) will be administered intravenously, 3 days prior to the start of placebo.

Protocol documents:
Clinical trial NCT00977197
Conditions: Irritable Bowel Syndrome
Sponsor: Mayo Clinic
Start date: 2010-03-01; Completion date: 2015-06-01
Enrollment: 85 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being done to see if Lyrica helps people with irritable bowel syndrome.

Detailed description:
Lyrica is the trade name for pregabalin, which was first approved by the FDA in June 2005 and has been available through prescription since fall 2005, and is marketed by Pfizer. Lyrica is known to have clinical efficacy treating pain disorders including irritable bowel syndrome-related conditions such as fibromyalgia.

Arms: arm 1: Subjects randomized to this arm will receive the following dosage:

75 mg (one tablet) twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study. arm 2: Subjects randomized to this arm will receive placebo matching the study drug.
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: Dose: 75 mg twice a day for three days, increasing to 150 mg (2 tablets) twice a day for three days, escalating to 225 mg (three tablets) twice a day, through week 12, day 1. Days 2-4 of week 12, participants will begin tapering and will receive 150 mg (two tablets) two times a day and then days 5-7, participants will receive 75 mg two times a day for the duration of the study. intervention 2: A matching placebo will be administered twice a day

Protocol documents:
Clinical trial NCT00994123
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Non-Small Cell Lung Cancer NSCLC Advanced Non-Small Cell Lung Cancer Metastatic Non-Small Cell Lung Cancer Lung Cancer Erlotinib Tarceva MM-121 ErbB3 Her3 Epidermal Growth Factor Receptor anti-ErbB3 human monoclonal antibody ErbB3 antagonist
Sponsor: Merrimack Pharmaceuticals
Start date: 2010-02-01; Completion date: 2015-06-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 1-2 study of MM-121 in combination with standard therapy for non-small cell lung cancer (NSCLC).

Detailed description:
Phase 1: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to evaluate the safety, tolerability and recommended Phase 2 dose of MM-121 in combination with standard therapy.

Phase 2: Patients with Non-Small Cell Lung Cancer (NSCLC) may be enrolled to estimate the progression-free survival of the MM-121 + standard therapy.

Arms: arm 1: Escalating doses of MM-121 (QOW IV) and erlotinib (daily PO) arm 2: Erlotinib (daily) arm 3: MM-121 (QOW IV) and erlotinib (daily PO)
Interventions: intervention 1: MM-121 intervention 2: Erlotinib
Intervention descriptions: intervention 1: MM-121 (SAR256212) = intravenous solution intervention 2: erlotinib = daily oral tablet

Protocol documents: