ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01473381
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Depression
Sponsor: Forest Laboratories
Start date: 2011-12-01; Completion date: 2013-06-01
Enrollment: 1162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate the efficacy, safety, and tolerability of 2 fixed dose levels of vilazodone compared to placebo in patients with major depressive disorder.

Detailed description:

Arms: arm 1: Participants received 2 placebo to vilazodone tablets, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. arm 2: Participants received 1 vilazodone tablet, 1 placebo to vilazodone tablet, and 1 placebo to citalopram capsule orally once daily for the 11 weeks of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20 mg/day during Weeks 2 to 10, and vilazodone 10 mg/day during Week 11. arm 3: Participants received 1 placebo to vilazodone tablet, 1 vilazodone tablet, and 1 placebo to citalopram capsule orally once daily during Weeks 1 and 2 of the study. Participants received 2 vilazodone tablets and 1 placebo to citalopram capsule orally once daily during Weeks 3 -10 of the study. Participants received vilazodone 10 mg/day during Week 1, vilazodone 20/day mg during Week 2, and vilazodone 40 mg/day during Weeks 3 to 10. During Week 11, participants received vilazodone 20 mg/day for 4 days and 10 mg/day for 3 days. arm 4: Participants received 2 placebo vilazodone tablets, and 1 citalopram capsule once daily for the 11 weeks of the study. Participants received citalopram 20 mg/day during Weeks 1 and 2, citalopram 40 mg/day during Weeks 3 to 10, and citalopram 20 mg/day during Week 11.
Interventions: intervention 1: Vilazodone intervention 2: Placebo to citalopram intervention 3: Placebo to vilazodone intervention 4: Citalopram
Intervention descriptions: intervention 1: Vilazodone was supplied as film-coated tablets. intervention 2: Placebo to citalopram was supplied as a capsule. intervention 3: Placebo to vilazodone was supplied as film-coated tablets. intervention 4: Citalopram was supplied as encapsulated tablets.

Protocol documents:
Clinical trial NCT01571362
Conditions: Chronic Pain Low Back Pain Analgesia
Keywords: oxycodone naltrexone chronic pain low back pain
Sponsor: Pfizer
Start date: 2012-06-01; Completion date: 2013-06-01
Enrollment: 410 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine the analgesic efficacy and safety of ALO-02 extended-release capsules, when compared to placebo, in subjects with moderate to severe chronic low back pain.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ALO-02 intervention 2: Placebo
Intervention descriptions: intervention 1: 20 to 160mg total daily dose of oxycodone, divided into symmetric doses and administered twice daily intervention 2: oral placebo, divided into symmetric doses and administered twice daily

Protocol documents:
Clinical trial NCT01572792
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: COPD Chronic Obstructive Pulmonary Disease Chronic Bronchitis Emphysema Airflow Obstruction, Chronic Chronic Airflow Obstruction Chronic Obstructive Airway Disease Chronic Obstructive Lung Disease
Sponsor: AstraZeneca
Start date: 2012-04-01; Completion date: 2013-06-01
Enrollment: 921 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this Phase III study is to evaluate the long-term safety and tolerability of two fixed-dose combinations of inhaled aclidinium bromide/formoterol fumarate, aclidinium bromide, formoterol fumarate and placebo in patients with moderate to severe Chronic Obstructive Pulmonary Disease (COPD). Long-term efficacy, pharmacoeconomic and health-related quality of life assessments will also be evaluated. This extension study will include a 28 week treatment period, followed by a four week follow up visit. All patients will remain in the same treatment group as for the lead-in study and continue on one of the four treatment arms or placebo.

Detailed description:

Arms: arm 1: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose arm 2: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose arm 3: Aclidinium bromide 400 μg arm 4: Formoterol Fumarate 12 μg arm 5: Placebo
Interventions: intervention 1: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) intervention 2: Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) intervention 3: Aclidinium bromide intervention 4: Formoterol Fumarate intervention 5: Placebo
Intervention descriptions: intervention 1: Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) high dose, twice per day intervention 2: Inhaled Aclidinium bromide/formoterol Fixed-Dose Combination (FDC) low dose, twice per day intervention 3: Inhaled Aclidinium bromide 400 μg, twice per day intervention 4: Inhaled Formoterol Fumarate 12 μg, twice per day intervention 5: Inhaled dose-matched placebo, twice per day

Protocol documents:
Clinical trial NCT00103194
Conditions: Recurrent Prostate Cancer Stage I Prostate Cancer Stage IIA Prostate Cancer Stage IIB Prostate Cancer Stage III Prostate Cancer
Sponsor: National Cancer Institute (NCI)
Start date: 2005-09-01; Completion date: 2013-06-01
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well lapatinib ditosylate works in treating patients with a rising prostate-specific antigen (PSA), a protein made by the prostate gland, indicating that prostate cancer has come back after previous treatment. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and may delay or prevent the progression of prostate cancer.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the percentage of patients with hormone sensitive prostate cancer who experience \> 50% decline in serum PSA during treatment with GW572016 (lapatinib ditosylate).

SECONDARY OBJECTIVES:

I. To evaluate the duration of PSA decline. II. To characterize the change in PSA slope with GW572016. III. To characterize the safety and tolerability of GW572016 in this patient population.

IV. To estimate the time to progression (TTP) and progression-free survival at 2 years (from start of therapy).

V. To evaluate the correlation of epidermal growth factor receptor (EGFR) expression/signaling (from available prostate biopsy specimens or prostatectomy blocks) and its relationship to change in PSA in patients treated with GW572016.

OUTLINE:

Patients receive lapatinib ditosylate orally (PO) daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 3 months if patient is \< 2 years from study entry, every 6 months if patient is 2-5 years from study entry, or every year if patient is 5-10 years from study entry for 10 years.

Arms: arm 1: Patients receive lapatinib ditosylate PO daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: lapatinib ditosylate intervention 2: laboratory biomarker analysis
Intervention descriptions: intervention 1: Given PO intervention 2: Correlative studies

Protocol documents:
Clinical trial NCT00121225
Conditions: Ciliary Body and Choroid Melanoma, Medium/Large Size Extraocular Extension Melanoma Iris Melanoma Uveal Melanoma Recurrent Intraocular Melanoma Recurrent Melanoma Stage IV Melanoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-09-01; Completion date: 2013-06-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well vorinostat works in treating patients with metastatic or unresectable melanoma. Vorinostat may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVE:

I. Determine the objective response rate in patients with metastatic or unresectable melanoma treated with vorinostat.

SECONDARY OBJECTIVES:

I. Determine time to progression in patients treated with this drug. II. Determine the utility of HP1 and/or macro H2A nuclear foci as biomarkers of response in patients treated with this drug.

III. Correlate the presence of 72R or 72P variant p53 polymorphisms with response and time to progression in patients treated with this drug.

IV. Determine gene expression profiles that may predict response to this drug and gene expression changes that occur after treatment with this drug in these patients.

OUTLINE: This is a multicenter study.

Patients receive oral vorinostat once daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed for 4 weeks and then every 3 months thereafter.

Arms: arm 1: Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.
Interventions: intervention 1: vorinostat
Intervention descriptions: intervention 1: Patients will receive vorinostat by mouth once a day for 4 weeks. Treatment may repeat every 4 weeks for as long as benefit is shown. Patients will be evaluated for 4 weeks and every 3 months thereafter.

Protocol documents:
Clinical trial NCT00131378
Conditions: Obesity
Keywords: Visceral obesity Growth hormone Cardiovascular risk Insulin resistance
Sponsor: Massachusetts General Hospital
Start date: 2004-11-01; Completion date: 2013-06-01
Enrollment: 142 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare growth hormone levels and cardiovascular risk markers in normal weight and overweight women and men. In women and men with increased abdominal weight, growth hormone (GH) versus placebo will be administered and effects on cardiovascular risk, insulin resistance and body composition will be measured.

Detailed description:
The purpose of this study is to measure growth hormone levels in women and men who are normal weight, overweight, and obese. Growth hormone levels will be correlated with body weight, body composition, and markers of cardiovascular risk. In overweight or obese women and men with increased visceral adiposity and below average IGF-1 levels, growth hormone versus placebo will be given for 6 months. Effects of growth hormone treatment on weight, body composition, insulin resistance, lipids, and cardiovascular risk markers will then be assessed. Study subjects will be followed for an additional six months for these endpoints.

Arms: arm 1: Participants received growth hormone replacement therapy. The starting dose was 2 micrograms/kg per day and they were titrated within the normal range based on blood levels.

Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. arm 2: Participants received placebo.

Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months. arm 3: Participants received growth hormone replacement therapy. The starting dose was 4 micrograms/kg per day and they were titrated within the normal range based on blood levels.

Nutropin AQ growth hormone : Participants gave themselves injections of growth hormone every night for 6 months. arm 4: Participants received placebo.

Placebo Growth Hormone : Participants gave themselves injections of placebo every night for 6 months.
Interventions: intervention 1: Nutropin AQ growth hormone intervention 2: Placebo Growth Hormone
Intervention descriptions: intervention 1: Participants will give themselves injections of growth hormone every night for 6 months. intervention 2: Participants will give themselves injections of placebo growth hormone every night for 6 months.

Protocol documents:
Clinical trial NCT00186121
Conditions: Breast Cancer
Sponsor: Stanford University
Start date: 2000-10-01; Completion date: 2013-06-01
Enrollment: 35 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the antitumor activity, toxicity, and effectiveness of the combination of goserelin (Zoladex) and anastrozole (Arimidex) in the treatment of premenopausal women with hormone receptor positive metastatic carcinoma of the breast.

Detailed description:
Pre-menopausal women with estrogen and/or progesterone receptor positive, metastatic or recurrent breast cancer were enrolled and treated with goserelin (Zoladex) monthly and began anastrozole (Arimidex) daily for 21 days following the first injection of goserelin. Participants continued on treatment until disease progression or unacceptable toxicity.

Arms: arm 1: Participants received goserelin 3.6 mg subcutaneously monthly. Beginning on Day 22 after the first dose of goserelin, participants began taking anastrozole 1 mg orally daily. No dose attenuation or escalation was allowed for either goserelin or anastrozole.
Interventions: intervention 1: Anastrozole (Arimidex) intervention 2: Goserelin (Zoladex)
Intervention descriptions: intervention 1: Anastrozole is a prescription hormonal treatment that helps fight breast cancer by lowering the amount of estrogen in the body. It is a non-steroidal aromatase inhibitor, which significantly lowers serum estradiol (estrogen) concentrations, without interfering with the formation of adrenal corticosteroids or aldosterone intervention 2: Goserelin is a palliative treatment of advanced breast cancer in pre- and perimenopausal women

Protocol documents:
Clinical trial NCT00237185
Conditions: Unresectable or Metastatic Malignant Gastrointestinal Stromal Tumor (GIST)
Keywords: GIST c-kit imatinib mesylate
Sponsor: Novartis Pharmaceuticals
Start date: 2000-06-01; Completion date: 2013-06-01
Enrollment: 148 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In the core study, participants with unresectable or metastatic gastrointestinal stromal tumors expressing c-kit were treated with either 400 mg or 600 mg imatinib mesylate for 3 years. The 10 year extension study allowed participants, who successfully completed the core study, to continue study treatment with imatinib mesylate provided they still benefited from treatment and did not demonstrate safety concerns as per the investigator's opinion.

Detailed description:

Arms: arm 1: 400 mg once daily arm 2: 600 mg once daily
Interventions: intervention 1: Imatinib mesylate
Intervention descriptions: intervention 1: Participants were randomized 1:1 to receive imatinib mesylate 400 mg/day or 600 mg/day. Upon unsatisfactory treatment effect on the starting dose of 400 mg/day or 600 mg/day imatinib mesylate, in the opinion of the treating physician, a dose increase up to 600 mg/day or 800 mg/day, was allowed provided that the participant continued to benefit from the treatment and in the absence of safety concerns.

Protocol documents:
Clinical trial NCT00312897
Conditions: Adolescent Depression
Keywords: Adolescents Depression Fish Oil Omega-3 Fatty Acids Psychiatry
Sponsor: Icahn School of Medicine at Mount Sinai
Start date: 2005-12-01; Completion date: 2013-06-01
Enrollment: 57 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Aim. To provide preliminary data about the efficacy of omega-3FA in the treatment of adolescent MDD. To address this aim, a 10-week double blind, placebo-controlled study of omega-3FA, using a flexible dose titration is proposed. Primary outcome measures will be: (1) change in the total score of the Children's Depression Rating Scale-Revised (CDRS-R) at the end of treatment (2) response rate on the Clinical Global Improvement scale (CGI) at the end of 10-week treatment.

Hypothesis. Omega-3FA treatment in adolescents with MDD will result in a significant reduction of CDRS-R total scores, and a significantly higher improvement rate on the CGI at the end of treatment compared to placebo.

Detailed description:
Title: Omega-3 Fatty Acids in Adolescents with Depression

NOTE: No individual will be advised to terminate ongoing treatment. If adolescents have been in psychotherapy prior to their entry in the study, they will be allowed to continue with the treatment. However, psychotherapy cannot be initiated at the time of entry into the study.

Aim: To provide preliminary clinical data about the efficacy of omega-3FA (derived from fish oil) in the treatment of adolescent MDD. A NCCAM/NIH-funded study.

Summary: Informed consent will be obtained from parent/guardian and assent obtained from participant. Interested participants will have a free diagnostic evaluation by study psychiatrist to determine eligibility. Routine blood tests and a urine pregnancy test will be obtained. Eligible participants will be randomized to receive either omega-3FA or matching placebo (corn oil) for 10 weeks. Patients will be seen weekly throughout the trial. Dosage will be titrated based on clinical response and side effects. At end of double-blind phase, participants will be referred to a clinician who will be informed of subjects' treatment. Depending on treatment received during double-blind phase, post-study treatment options will include treatment with omega-3 fatty acids or an SSRI.

Arms: arm 1: as stated arm 2: as stated
Interventions: intervention 1: Omega-3 Fatty Acids intervention 2: corn oil
Intervention descriptions: intervention 1: 10 wk treatment period intervention 2: placebo comparator

Protocol documents:
Clinical trial NCT00388726
Conditions: Breast Cancer
Keywords: Locally recurrent breast cancer metastatic breast cancer
Sponsor: Eisai Inc.
Start date: 2006-11-01; Completion date: 2013-06-01
Enrollment: 762 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare Overall Survival (OS), Progression Free Survival (PFS), objective tumor response rate, duration of response, and safety in patients treated with E7389 versus the Treatment of Physician's Choice (TPC) in patients with locally recurrent or metastatic breast cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: E7389 intervention 2: Physician's Choice
Intervention descriptions: intervention 1: 1.4 mg/m\^2 intravenous (IV) infusion given over 2-5 minutes on Days 1 and 8 every 21 days. intervention 2: Treatment of the Physician's Choice defined as any single agent chemotherapy, hormonal treatment or biological therapy approved for the treatment of cancer; or palliative treatment or radiotherapy, administered according to local practice, if applicable.

Protocol documents:
Clinical trial NCT00412061
Conditions: Carcinoid Tumor Malignant Carcinoid Syndrome
Keywords: Cancer Carcinoid Tumor Neuroendocrine Carcinoma Everolimus Octreotide
Sponsor: Novartis Pharmaceuticals
Start date: 2006-12-01; Completion date: 2013-06-01
Enrollment: 429 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to evaluate whether everolimus 10 mg / day added to treatment with depot octreotide prolongs progression free survival compared to treatment with octreotide alone in patients with advanced carcinoid tumor.

Detailed description:

Arms: arm 1: Everolimus was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity. Each treatment cycle lasted 28 days. Patients received their first dose of everolimus at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1, Day 1. arm 2: Matching placebo was administered in accordance with a 10-mg daily dosing regimen (two 5-mg tablets) in conjunction with octreotide 30 mg intramuscularly (i.m.) every 28 days. Patients were treated until progression or unacceptable toxicity; Each treatment cycle lasted 28 days. Patients received their first dose of matching placebo at Cycle 1, Day 1. Administration of octreotide was performed every 28 days (± 4 days) starting on Cycle 1 Day 1.
Interventions: intervention 1: Octreotide intervention 2: Placebo intervention 3: Everolimus
Intervention descriptions: intervention 1: Octreotide 30 mg intramuscularly (i.m.) every 28 days. intervention 2: A 10-mg oral daily dosing regimen (two 5-mg tablets) of matching placebo. intervention 3: A 10-mg oral daily dosing regimen (two 5-mg tablets) of everolimus.

Protocol documents:
Clinical trial NCT00490009
Conditions: Lymphoma
Sponsor: Susan Knox
Start date: 2004-09-01; Completion date: 2013-06-01
Enrollment: 9 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to obtain safety and efficacy data using Bexxar in patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL).

Detailed description:
There is a lack of efficacious treatment options for patients with relapsed/refractory diffuse large cell Non-Hodgkin's lymphoma (DLCL) who are not appropriate candidates for stem cell transplantation. DLCL is a relatively radiosensitive disease and patients with DLCL have been reported to respond to anti-CD20 monoclonal antibody (MAB) therapy. Therefore, radioimmunotherapy targeting CD20 is a rational and promising therapeutic approach for this patient population.

This study evaluated if Bexxar is safe and efficacious for diffuse large cell Non-Hodgkin's lymphoma.

Arms: arm 1: Bexxar will be administered with pre-medications acetaminophen, diphenhydramine, and potassium iodide (KI).
Interventions: intervention 1: Bexxar intervention 2: Acetaminophen intervention 3: Diphenhydramine intervention 4: Potassium Iodide (KI)
Intervention descriptions: intervention 1: Bexxar is a radioimmunotherapeutic drug, an antibody that specifically attaches to the CD20 antigen, which is present on the surfaces of B cells and B cell lymphoma cells. The radioactive isotope then gives off radiation, which kills the cells.

Bexxar will be administered to provide the following patient-specific radiotherapy:

* Platelet count of 150,000/mm³ = 75 cGy
* Platelet count ≥ 100,000/mm³ but \< 150,000/mm³ = 65 cGy intervention 2: As premedication 30 to 60 minutes before antibody infusion; 650 mg, oral. Used to as to relieve pain intervention 3: As premedication 30 to 60 minutes before antibody infusion; 50 mg, oral. Used to prevent inflammation or allergic reactions intervention 4: Administered to prevent thyroid blockage 130 mg orally 3 times a day,

Protocol documents:
Clinical trial NCT00547456
Conditions: Chronic Obstructive Pulmonary Disease
Sponsor: Northwell Health
Start date: 2005-10-01; Completion date: 2013-06-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We will determine whether oxygen therapy lowers the level of substances in the blood which cause inflammation, which is one of the adverse effects of COPD and whether oxygen improves overall well being and quality of life as well as sleep quality.

Detailed description:
Hypothesis: Isolated nocturnal hypoxemia contributes to chronic systemic inflammation in COPD by activating circulating neutrophils.

Arms: arm 1: Patients are their own controls and tested pre and post the addition of night time supplemental oxygen
Interventions: intervention 1: Oxygen
Intervention descriptions: intervention 1: Oxygen 2-3L Nasal cannula

Protocol documents: