ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00338598
Conditions: Alcoholism Schizophrenia
Keywords: glycine treatment alcohol dependence schizophrenia
Sponsor: Yale University
Start date: 2003-06-01; Completion date: 2015-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This placebo-controlled study is designed to evaluate the efficacy of glycine, an agonist of the glycine-B co-agonist site of the NMDA receptor, on alcohol consumption and craving as well as negative symptoms in schizophrenia.

Glycine will decrease the rewarding action of ethanol and reduce ethanol consumption. Also, glycine will improve negative symptoms and cognitive deficits in schizophrenia.

Detailed description:
OBJECTIVE: Schizophrenia affects about 1% of the general population and is a highly disabling disease. Additionally, the rate of alcohol dependency for patients with schizophrenia is very high. There are no established treatments for alcohol dependency and negative symptoms in schizophrenia. This study will examine whether the addition of glycine to neuroleptic medications will help patients with schizophrenia and alcoholism decrease their drinking as well as improve negative symptoms.

RESEARCH PLAN: An abnormality of the glutamate neurotransmitter system has been hypothesized for both alcoholism and schizophrenia. Studies suggest that the amino acid glycine may improve alcohol dependency and symptoms of schizophrenia by acting on the N methyl D aspartate (NMDA) glutamate receptor. Glycine causes reversal of the effects of ethanol in animal studies and improves mood, social withdrawal and other so called "negative symptoms" of schizophrenia. Consequently, the use of glycine by patients with schizophrenia and alcohol dependency may potentially decrease alcohol craving and alcohol consumption and also improve certain symptoms of schizophrenia. The potential of glycine to improve both alcohol dependency and negative symptoms could represent an important step in the improvement of the quality of life for patients with schizophrenia.

METHODOLOGY/FINDINGS/RESULTS: In order to test this hypothesis, we will use a double blind, placebo controlled study and measure the number of drinks, the degree of craving for alcohol and symptoms of schizophrenia among other parameters. Our principal approach to analyses of medication effectiveness will be the application of the linear mixed effect model. The linear mixed effect model permits a flexible approach for studying change in individuals through time as a random effect, and does not require all patients to have data at all measured points. Our principal model of analysis includes treatment (placebo or glycine), as between subject factor, and time, as within subject factor. Compliance will be also included as a time varying independent variable. This project continues to recruit subjects.

Arms: arm 1: Glycine, 0.8 gr per kg given in two daily doses arm 2: placebo will be administered.
Interventions: intervention 1: Glycine intervention 2: placebo
Intervention descriptions: intervention 1: Glycine, 0.8 gr per kg given in two daily doses intervention 2: None

Protocol documents:
Clinical trial NCT00476086
Conditions: Mixed Mullerian Tumors of the Uterus
Keywords: oxaliplatin gemcitabine MMMT
Sponsor: Dana-Farber Cancer Institute
Start date: 2006-08-01; Completion date: 2015-12-01
Enrollment: 20 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to determine the feasibility and safety of giving the combination of oxaliplatin and gemcitabine followed by radiation therapy and to learn whether or not this drug combined with radiation therapy works in treating women with Mullerian tumors of the uterus.

Detailed description:
OBJECTIVES:

Primary To determine the feasibility of dual modality therapy described as cytotoxic therapy followed by radiation therapy for the management of Malignant Mixed Mullerian Tumors (MMMTs).

Secondary

\* To describe the response rate by Response Evaluation Criteria in Solid Tumors

STATISTICAL DESIGN:

This study used a two-stage design to evaluate feasibility of oxaliplatin and gemcitabine prior to radiation therapy defined as completing 3 cycles of chemotherapy. The null and alternative therapy completion rates were 25% and 50%. If 3 or more participants enrolled in the stage one cohort (n=9 participants) complete therapy than accrual would proceed to stage two (n=15 participants). If therapy was completed by at least 10 participants in the final set of 24 evaluable participants then this regimen would be deemed worthy of further study. This design had 80% power given one-sided type I error of 5% with the probability of stopping early 0.60.

Arms: arm 1: Patients rcvd IV chemotherapy on days 1 and 15 of a 4-week cycle: gemcitabine 1000 mg/m2 and oxaliplatin 65 mg/m2 for up to 3 cycles. Two dose reductions per study drug were permitted. On study, chemotherapy was followed by radiation therapy (RT) within 4-6 weeks of last chemotherapy. RT regimen was tumor-volume directed.
Interventions: intervention 1: Gemcitabine intervention 2: Oxaliplatin intervention 3: Radiation
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT00517296
Conditions: Crohn Disease Rectal Fistula
Sponsor: Vanderbilt University Medical Center
Start date: 2008-01-01; Completion date: 2015-12-01
Enrollment: 21 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is to assess whether utilizing endoscopic ultrasound(EUS) to guide treatment can improve durable fistula healing in patients with Crohn's perianal fistulas and to get preliminary information regarding the effectiveness of Adalimumab for Crohn's perianal fistulas.

Detailed description:
Prospective randomized trial to assess the effectiveness of rectal EUS to guide perianal fistula treatment. Our hypothesis is that using imaging, in this case endoscopic ultrasound (EUS), to initially evaluate and then guide therapy with an anti-TNF agent (adalimumab) for fistulizing disease will lead to better short- and long-term outcomes.

Arms: arm 1: Patients will be randomized to adalimumab treatment with EUS guided therapy decisions. Colorectal surgeon will have access to EUS data prior to EUA with possible seton placement. arm 2: Patients will be randomized to adalimumab treatment. Colorectal surgeon will not have access to EUS data prior to EUA with possible seton placement.
Interventions: intervention 1: EUA with seton placement if necessary intervention 2: adalimumab intervention 3: EUS
Intervention descriptions: intervention 1: Patients randomized to the combination therapy group, the surgeon will have access to EUS findings. intervention 2: Patients began therapy with adalimumab using clinic standards for dosing. intervention 3: Patients in combination therapy group had an EUS done every 12 weeks to help guide therapy.

Protocol documents:
Clinical trial NCT00528398
Conditions: Leukemia
Keywords: adult acute megakaryoblastic leukemia (M7) adult acute minimally differentiated myeloid leukemia (M0) adult acute monoblastic leukemia (M5a) adult acute monocytic leukemia (M5b) adult acute myeloblastic leukemia with maturation (M2) adult acute myeloblastic leukemia without maturation (M1) adult acute myelomonocytic leukemia (M4) adult erythroleukemia (M6a) adult pure erythroid leukemia (M6b) adult acute myeloid leukemia with 11q23 (MLL) abnormalities adult acute myeloid leukemia with inv(16)(p13;q22) adult acute myeloid leukemia with t(16;16)(p13;q22) adult acute myeloid leukemia with t(8;21)(q22;q22) secondary acute myeloid leukemia untreated adult acute myeloid leukemia
Sponsor: City of Hope Medical Center
Start date: 1994-09-01; Completion date: 2015-12-01
Enrollment: 111 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as idarubicin and cytarabine, work in different ways to stop the growth of cancer cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more cancer cells.

PURPOSE: This phase II trial is studying how well giving idarubicin together with high-dose cytarabine works in treating patients with acute myeloid leukemia.

Detailed description:
OBJECTIVES:

* Determine the complete remission rate (CR).
* Determine the proportion of patients who are bone marrow-positive at day 7 post-induction chemotherapy.
* Further evaluate the toxicity of this regimen.

OUTLINE: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.

Arms: arm 1: Patients receive cytarabine IV over 3 hours every 12 hours on days 1-4 and idarubicin IV over 5-10 minutes on days 1-3. Patients undergo bone marrow aspirate and biopsy 7 days after completion of induction chemotherapy. Patients with \> 25% cellular biopsy or \> 10% abnormal cells on aspirate receive 4 more doses of cytarabine and 1 dose of idarubicin.
Interventions: intervention 1: cytarabine intervention 2: idarubicin
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00573378
Conditions: Chronic Myeloid Leukemia
Keywords: CML
Sponsor: University of Michigan Rogel Cancer Center
Start date: 2007-09-01; Completion date: 2015-12-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To investigate whether patients with chronic-phase chronic myeloid leukemia (CP-CML) who have achieved a complete cytogenetic response (CCyR) on imatinib (IM) or nilotinib (N) can then be treated with a combination of the tyrosine kinase inhibitor (TKI) and interferon-α2b (PEG-IFN-a2b, \[IFN\]) for 2 years, subsequently have their therapy discontinued, and then maintain a durable molecular response off all therapy. Relapse-free survival (RFS) rate 1 year after discontinuation of the TKI and IFN will be the measurement of this objective.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: PEG-IFN-a2b
Intervention descriptions: intervention 1: Patients will receive pegylated interferon α-2b (Pegintron®) (PEG-IFN-α2b) 150 µg subcutaneously, once a week. Patients and/or caregivers identified by the patient will be taught how to perform subcutaneous injections of the PEG-IFN-α2b by trained nurses in the chemotherapy infusion center at the University of Michigan Comprehensive Cancer Center. Those patients who do not feel comfortable receiving the injections outside of the cancer center, or are deemed unreliable in administering injections per the training nurse, will return to the cancer center infusion room on a weekly basis to receive subsequent injections.

Protocol documents:
Clinical trial NCT00668811
Conditions: Papillary Thyroid Cancer Follicular Thyroid Cancer Differentiated Thyroid Cancer
Keywords: thyroid cancer metastatic thyroid cancer differentiated thyroid cancer papillary thyroid cancer follicular thyroid cancer Histologically confirmed metastatic stage 2,stage 3, or stage 4 differentiated thyroid cancer
Sponsor: Medstar Health Research Institute
Start date: 2008-04-01; Completion date: 2015-12-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study is comparing a drug called Sutent with standard of care treatment for people with advanced thyroid cancer. Because advanced thyroid cancer is becoming increasingly common and effective treatment options are limited, new therapies are desperately needed.

This study is designed to see if Sutent following therapy with radioactive iodine will target cancer cells and delay disease progression better than standard therapy alone. Newly diagnosed patients, who are scheduled to receive radioactive iodine as part of their standard care are possible candidates. By entering into this study, participants agree to take oral Sutent for approximately two years after completing standard therapy. During this time, study participants will be followed closely by their doctor.

Detailed description:
This is a two-stage, phase II, single center, targeted therapy trial enrolling patients with stage 2 (for patients younger than 45 years of age), 3 or 4 differentiated thyroid cancer. The primary objective is to assess progression free survival in this population. Sutent will be given orally at 37.5mg daily for two (2) year, or 26 cycles. Each treatment cycle will consist of 28 days. Upon treatment discontinuation, patients will be followed for survival. The frequency and type of survival follow-up assessments performed will be at the discretion of the treating physician.

Arms: arm 1: Sutent 37.5 mg/day will be given orally.
Interventions: intervention 1: SU011248, Sutent
Intervention descriptions: intervention 1: Sutent 37.5 mg/day will be given orally after radioactive iodine therapy. Total time of Sutent drug administration will be 52 weeks, absent unacceptable toxicity or disease progression. Sutent is supplied as 12.5mg and 25 mg tablets. Patients are to swallow the tablets whole with approximately 250 ml (8 oz.) of water, fasting each morning. Patients will be given monthly calendars (patient diaries) to document the time when the Sutent pills are taken. At monthly visits, patients will bring back this record and the drug bottles.

Protocol documents:
Clinical trial NCT00705250
Conditions: Hodgkin's Disease Lymphoma
Keywords: Bendamustine HCL
Sponsor: Memorial Sloan Kettering Cancer Center
Start date: 2008-06-01; Completion date: 2015-12-01
Enrollment: 36 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The standard treatment for patients with HL that has not responded to treatment or has come back after treatment is stem cell transplant. When patients are not eligible for transplant or when HL comes back after transplant, there are no standard treatment options. These patients can receive chemotherapy or participate in clinical trials. Bendamustine HCl is a chemotherapy agent that is effective in treating patients with various diseases, including non-Hodgkin's lymphoma, multiple myeloma, and breast cancer. It was recently approved for the treatment of chronic lymphocytic leukemia. In addition, small studies from Eastern Europe have shown that bendamustine HCl is likely effective for treating HL. This study will find out the effect of bendamustine HCl for transplant-ineligible patients with HL that has not responded to or has come back after treatment.

Detailed description:

Arms: arm 1: bendamustine hcl 120mg/m\^2
Interventions: intervention 1: bendamustine hcl
Intervention descriptions: intervention 1: Patients will receive bendamustine 120mg/m\^2, administered as a 30-minute infusion, for two consecutive days. Cycles will be repeated every four weeks and a total of 6 cycles will be planned. Patients will receive pegfilgrastim with each cycle. Treatment will be delayed until the absolute neutrophil count is \> 1000/ul and the platelet count is \> 75,000/ul.

Protocol documents:
Clinical trial NCT00728728
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: pregnenolone schizophrenia cognitive positive symptom negative symptom placebo control
Sponsor: VA Office of Research and Development
Start date: 2009-12-01; Completion date: 2015-12-01
Enrollment: 88 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will investigate adjunctive pregnenolone for patients with schizophrenia and schizoaffective disorder.

Detailed description:

Arms: arm 1: Pregnenolone arm 2: Placebo
Interventions: intervention 1: Dietary Supplement: Pregnenolone intervention 2: Placebo
Intervention descriptions: intervention 1: Pregnenolone 50mg BID x 14 days, followed by Pregnenolone 150 x 14 days, followed by Pregnenolone 250 mg BID x thereafter for the remainder of the 8-week trial. intervention 2: Placebo

Protocol documents:
Clinical trial NCT00734162
Conditions: Hepatitis B Virus (HBV)
Keywords: tenofovir adolescents chronic hepatitis B
Sponsor: Gilead Sciences
Start date: 2008-12-01; Completion date: 2015-12-01
Enrollment: 106 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of the study is to evaluate the effectiveness, safety, and tolerability of tenofovir disoproxil fumarate (TDF) in adolescents (aged 12-17 years) with chronic hepatitis B virus (HBV) infection.

The optimal treatment for adolescents with chronic HBV infection is currently unknown. Treatment with interferon alfa, lamivudine, and adefovir dipivoxil in pediatric populations has been shown to be less than optimal. Further, the safety and efficacy of entecavir and telbivudine have not been established in patients \< 16 years of age. A study evaluating TDF in adolescents (ages 12-17) was needed to assess the safety and efficacy of this agent in the treatment of chronic hepatitis B in this patient population. In addition, the study will help to further elucidate the pharmacokinetic (PK) and resistance profiles of TDF. Through their participation, study participants will help generate critical new information to help guide the most optimal treatment of chronic HBV infection in adolescents.

This is a randomized, double-blind study to evaluate the antiviral efficacy, safety, and tolerability of TDF versus placebo in adolescents with chronic HBV infection. TDF treatment-naive participants were randomized in a 1:1 ratio to TDF or placebo. After 72 weeks of blinded treatment, participants were to switch to open-label TDF for an additional 2.5 years of treatment, provided that no safety concerns are identified by the Independent Data Monitoring Committee monitoring the study.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tenofovir disoproxil fumarate (TDF) intervention 2: Placebo
Intervention descriptions: intervention 1: TDF administered as a 300-mg tablet once daily intervention 2: TDF placebo tablet once daily

Protocol documents:
Clinical trial NCT00795665
Conditions: Glioma
Keywords: adult anaplastic astrocytoma adult glioblastoma adult gliosarcoma adult giant cell glioblastoma adult anaplastic oligodendroglioma adult mixed glioma recurrent adult brain tumor
Sponsor: University of California, Davis
Start date: 2008-06-01; Completion date: 2015-12-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy, such as carmustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with carmustine may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving bevacizumab together with carmustine works in treating patients with relapsed or progressive high-grade glioma.

Detailed description:
OBJECTIVES:

Primary

* To determine the 6-month progression-free survival of patients with relapsed or progressive high-grade gliomas treated with bevacizumab and carmustine.

Secondary

* To evaluate the radiographic response to this regimen as measured by MRI and PET scan with image fusion.
* To utilize novel brain imaging to differentiate between a radiographic response due to tumor shrinkage and a radiographic response due to decreased vasogenic edema.
* To evaluate the safety and toxicity of this regimen in these patients.
* To evaluate the overall survival of these patients.

OUTLINE: Patients receive bevacizumab IV on days -7, 8, 22, 36, and 50 of course 1 and on days 8, 22, 36, and 50 of all subsequent courses. Patients also receive carmustine IV over 4 hours on day 1. Treatment repeats every 56 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed every 3 months.

Arms: arm 1: None
Interventions: intervention 1: bevacizumab intervention 2: carmustine
Intervention descriptions: intervention 1: Bevacizumab (10 mg/kg) will be given intravenously every other week starting one week before the first dose of BCNU. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU. intervention 2: BCNU (200 mg/m2), will be given over 4 hours as a continuous intravenous infusion every 8 weeks. Treatment with both BCNU and bevacizumab for 6-months, after which the participant may continue to receive bevacizumab every 2 weeks for a maximum of one year and three additional cycles of BCNU.

Protocol documents:
Clinical trial NCT00811135
Conditions: Breast Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-12-01; Completion date: 2015-12-01
Enrollment: 88 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study will assess the efficacy and safety of Avastin in combination with Herceptin and Xeloda as first-line treatment of patients with HER2-positive locally recurrent or metastatic breast cancer. Patients will receive 3-weekly treatment cycles of Herceptin (8mg/kg iv on day 1 of first cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles), Xeloda (1000mg/m2 bid po on days 1-14 of each treatment cycle) and Avastin (15mg/kg on day 2 of first treatment cycle,and on day 1 of each subsequent cycle).The anticipated time on study treatment is until disease progression, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: bevacizumab [Avastin] intervention 2: capecitabine [Xeloda] intervention 3: trastuzumab [Herceptin]
Intervention descriptions: intervention 1: 15mg/kg iv on day 2 of first 3-week cycle,and on day 1 of subsequent cycles intervention 2: 1000mg/m2 bid po on days 1-14 of each 3-week cycle intervention 3: 8mg/kg iv loading dose on day 1 of first 3-week cycle, followed by 6mg/kg iv maintenance dose on day 1 of subsequent cycles

Protocol documents:
Clinical trial NCT00832871
Conditions: Cancer
Keywords: Mifepristone RU-486 Compassionate Use Antiprogesterone
Sponsor: New Mexico Cancer Research Alliance
Start date: 2008-11-01; Completion date: 2015-12-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to see if mifepristone prevents worsening of your cancer. Mifepristone is an antiprogesterone agent, a drug which blocks female hormones, that is commonly used for the termination of pregnancies. It has not been approved by the Food and Drug Administration for use in the treatment of cancer. It is unlicensed in the United States for your condition. However, previous work has indicated that mifepristone may be useful due to how it works. It is being made available for use in the United States for compassionate use through the Feminist Majority Foundation.

Detailed description:
This is a compassionate use of mifepristone treatment for patients with conditions that could respond to an antiprogesterone agent, including:

* Meningioma.
* Breast cancer
* Colon Cancer
* Endometrial Stromal Sarcoma
* Bilateral Chronic Central Serous Retinopathy
* Cushing's Syndrome
* Metastatic Adrenocortical Cancer
* Ovarian Cancer
* Other conditions as determined by the attending physicians

Arms: arm 1: 200 mg RU-486 (Mifepristone) daily
Interventions: intervention 1: Mifepristone
Intervention descriptions: intervention 1: Mifepristone 200 mg will be administered orally

Protocol documents: