ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00361257
Conditions: HIV Infections
Keywords: Treatment Experienced
Sponsor: Advancing Clinical Therapeutics Globally for HIV/AIDS and Other Infections
Start date: 2007-03-01; Completion date: 2010-01-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effectiveness of minocycline, an antibiotic, in lessening the decreased mental function sometimes caused by anti-HIV drugs.

Detailed description:
Cognitive impairment, including disabling cognitive, behavioral, and social dysfunction, continues to be a major problem faced by HIV-infected people taking antiretroviral therapy (ART). Research is needed to develop treatment that can be given alongside ART to prevent or lessen cognitive impairment caused by ART. Minocycline, an antibiotic commonly used for the treatment of acne and rheumatoid arthritis, has demonstrated anti-inflammatory and neuroprotective properties in previous studies. This study will evaluate the effectiveness of 24-week therapy with minocycline in lessening the cognitive impairment of HIV infected adults taking ART.

This study will last at least 24 weeks and has two steps. Patients will be stratified by HIV viral load and their neurocognitive state at study screening. In Step I, patients will be randomly assigned to one of two groups. Group 1 participants will receive twice-daily minocycline for 24 weeks; Group 2 participants will receive placebo. At the end of Phase I, study participants will be offered to enter Step II; all participants in Step II will receive twice-daily minocycline for an additional 24 weeks.

There will be a total of 8 study visits: 5 visits for Step I (including the entry visit) and 3 visits for Step II. Medical history will occur at all visits. Blood collection will occur at all visits. Participants who have positive nonreactive rapid plasma regain (RPR) values at screening will have mandatory lumbar punctures; for those with negative serum RPR results lumbar punctures are optional. Participants who test positive for syphilis will also have a lumbar puncture at their discretion to determine if syphilis has affected the brain. A neurological exam, other neuropsychological, dementia, and depression scale assessments, and urine collection will occur at most visits. Patients will be asked to complete a questionnaire on daily living at study entry and Weeks 12 and 24. Patients who have a lumbar puncture at Week 24 will receive a phone call 2 to 5 days after the procedure to report any adverse effects. Some participants may also have an electrocardiogram (ECG) during the study. For participants not on atazanavir some procedures and sample collections are optional.

Arms: arm 1: 100 mg orally every 12 hours arm 2: orally every 12 hours
Interventions: intervention 1: Minocycline intervention 2: Placebo (Tetracycline)
Intervention descriptions: intervention 1: Tetracycline antibiotic, 100 mg taken orally every 12 hours intervention 2: Tetracycline antibiotic placebo, orally every 12 hours

Protocol documents:
Clinical trial NCT00366626
Conditions: Alcohol Dependence
Keywords: Alcohol dependence Alcoholism Craving Genetic
Sponsor: Medical University of South Carolina
Start date: 2006-04-01; Completion date: 2010-01-01
Enrollment: 83 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether naltrexone (an opiate blocking agent approved for the treatment of alcohol dependence) is more effective in the reduction of alcohol craving and drinking compared to placebo in individuals with particular genetic predisposition.

Detailed description:
About 300 non-treatment seeking alcoholics will be recruited through advertisement and paid for their participation. They will be assessed, subtyped for mu-opiate receptor and catechol-O-methyltransferase (COMT) allelic variants and 88 individuals (44 with the more common AA gene and 44 with either an AG or GG gene) will be randomly assigned to take either naltrexone (50 mg/day) or a matching placebo for 7 days. Since the val and met alleles of the catechol-O-methyltransferase (COMT) gene are each present in about 50% of the population they will be equally distributed by urn randomization to all opiate allele and treatment groups. After 5 days of natural drinking and one day of abstinence, subjects will undergo an alcohol cue-induced brain activity scan using well-established fMRI techniques on Day 6 of study drug. The following day all subjects will receive a standard dose (gender and weight corrected) of alcohol and be evaluated for alcohol reactivity (stimulation, sedation, intoxication, craving) over 40 minutes. They then will be allowed to consume up to 8 mini-drinks over a 2-hour period. Afterwards all subjects will receive educational/motivational counseling regarding their alcohol use and its effects. Referral for treatment will be offered.

Arms: arm 1: Naltrexone one capsule a day arm 2: One capsule a day match to naltrexone
Interventions: intervention 1: Naltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: Naltrexone (25 mg/day for days 1-2 and 50 mg/day for days 3-7) intervention 2: Placebo for 7 days matched to Naltrexone

Protocol documents:
Clinical trial NCT00373672
Conditions: Schizophrenia Schizoaffective Disorder
Keywords: schizophrenia cognition
Sponsor: Northwestern University
Start date: 2006-08-01; Completion date: 2010-01-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a six week, double blind,placebo controlled study for patients with schizophrenia or schizoaffective disorder treated with an atypical antipsychotic for at least two months. Subjects will be randomized to take armodafinil (Nuvigil) or placebo along with their current antipsychotic and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.

Detailed description:

Arms: arm 1: First group will be randomized to take Armodafinil (Nuvigil) 150 mg, along with their current anti psychotic medication and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked. arm 2: Second group will be randomized to take placebo,identical in appearance to active comparator, along with their current anti psychotic medication and tested at baseline and week 6 for differences in memory, attention and problem-solving ability. Changes in weight during the six week study will also be tracked.
Interventions: intervention 1: armodafinil (Nuvigil) intervention 2: placebo
Intervention descriptions: intervention 1: armodafinil (Nuvigil)150 mg qd intervention 2: identical in appearance to active comparator

Protocol documents:
Clinical trial NCT00376805
Conditions: Breast Cancer
Keywords: stage IV breast cancer male breast cancer recurrent breast cancer
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2006-04-01; Completion date: 2010-01-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Giving chemotherapy before a donor natural killer (NK) cell infusion helps stop the growth of tumor cells. It also helps stop the patient's immune system from rejecting the donor's cells. Giving NK cells from a related donor may kill the tumor cells.

PURPOSE: This study furthers the research of previous studies (MT2003-01 and MT2004-25) which were to determine a specific preparatory regimen (cyclophosphamide and fludarabine) could create an environment in which infused NK cells can grow and effectively treat patients with relapsed AML. This study will test the previous regimen in patients with breast cancer.

Detailed description:
We believe that administration of related allogeneic (donor) natural killer cells along with IL-2, rather than autologous natural killer cells will provide the most effective anticancer therapy in this setting, and wish to test this approach. To do this, we will select a related donor who is partially HLA-matched with the study subject, to increase the likelihood that donor natural killer cells will kill the subject's cancer cells. We will also give chemotherapy drugs to increase the subject's tolerance for the donor natural killer cells. We will test the use of donor natural killer (NK) cell infusions. The immune system has a special way that it sees and identifies cancer cells or foreign agents (like viruses). The subject's own NK cells may not attack their cancer because NK cells see the tumor cells as "self" (a coating on the cell surface identifies a cell as "self" or "non-self"). We have reason to believe that NK cells may not kill cancer cells because NK cells have special receptors that "turn them off" when they encounter cancer cells (by seeing them as "self"). We may be able to get around this problem by using donor NK cells. Finally, subjects will receive a dose of subcutaneous IL-2 3 times a week (for 2 weeks) which has been proven safe in our previous studies to stimulate the natural killer cells.

Arms: arm 1: All patients with advanced metastatic breast cancer treated with natural killer cells after receiving fludarabine, cyclosphosphamide and total body irradiation.
Interventions: intervention 1: Fludarabine intervention 2: Cyclophosphamide intervention 3: Total body irradiation intervention 4: Natural killer cell infusion intervention 5: Interleukin-2
Intervention descriptions: intervention 1: administered intravenously 25 mg/m\^2 times 5 doses intervention 2: administered intravenously 60 mg/kg days times 2 doses. intervention 3: 200 cGy (gray) on day -1 intervention 4: Infused cell dose is within the range of 1.5-8.0 x 10\^7/kg. Cell counts are based on total cells infused after the activation culture and washing determined on the morning of infusion. intervention 5: administered subcutaneously (10 MU) 3 times per week for 6 doses

Protocol documents:
Clinical trial NCT00388414
Conditions: Low Back Pain
Sponsor: Stanford University
Start date: 2006-09-01; Completion date: 2010-01-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Duloxetine has recently been shown to be effective in reducing the pain in chronic pain patients. Duloxetine is known to exert a central mechanism, however the precise human brain structures responsible for mediating its pain-relieving properties are not known. We will use functional magnetic resonance imaging (FMRI) to investigate the neural and functional correlates of pain.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: duloxetine intervention 2: Placebo
Intervention descriptions: intervention 1: 30-60mg of duloxetine daily intervention 2: Placebo pill once daily

Protocol documents:
Clinical trial NCT00414700
Conditions: Articular Cartilage Lesion of the Femoral Condyle
Keywords: Cartilage Articular Femoral Knee
Sponsor: TiGenix n.v.
Start date: 2002-02-01; Completion date: 2010-01-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase III, multicenter, open-label, randomized controlled trial of ChondroCelect® in an Autologous Chondrocyte Implantation (ACI) procedure compared to the procedure of microfracture (MF) in the repair of symptomatic cartilage lesions of the knee. Eligible patients attended two screening visits and were booked for arthroscopy approximately 2 weeks later. At that time, patients were randomized to either ACI with ChondroCelect® or to MF, a procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar tissue. Patients randomized to MF had the procedure performed at the time of their arthroscopy; those randomized to ACI with ChondroCelect® had their cells harvested during the arthroscopy and then returned to the clinic approximately 4 weeks later for an open knee procedure, during which the ACI procedure using ChondroCelect® was performed. Patients subsequently followed the same rehabilitation program and had follow-up assessments up to 12 months post-surgery. The 12-month visit was the end-of-study visit for the TIG/ACT/01/2000 protocol. Subject to satisfying the eligibility criteria, patients who had participated in the initial 12 month trial could enter the extension trial. The 12-month visit for the initial study was the baseline visit for the extension study. During the extension study, patients have follow-up assessments up to 60 months post-surgery.

Detailed description:
see above

Arms: arm 1: None arm 2: None
Interventions: intervention 1: ChondroCelect implantation intervention 2: Microfracture
Intervention descriptions: intervention 1: 10.000 cells/µl cell suspension for implantation (Autologous Chondrocyte Implantation). ChondroCelect consists of characterised autologous cartilage-forming cells expressing a specific marker profile.

The dose depends on the size of the lesion. Recommended dose is 0.8 to 1.0 million cells/cm². intervention 2: A procedure in which the subchondral bone is perforated to allow a bloodcloth to form scar tissue.

Protocol documents:
Clinical trial NCT00438932
Conditions: Chronic Kidney Disease
Keywords: phosphate, phosphorus, FGF-23, PTH, 1,25D
Sponsor: Massachusetts General Hospital
Start date: 2007-01-01; Completion date: 2010-01-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to learn more about how the kidneys control the blood levels of phosphorus in patients with early chronic kidney disease. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.

Detailed description:
Phosphorus is a mineral found in dairy products, nuts, and meat that is essential for bone health and many other important functions inside the body's cells. The kidneys are responsible for keeping the blood levels of phosphorus normal. Healthy kidneys do this by spilling excess phosphorus into the urine. In patients with chronic kidney disease, the kidneys are unable to spill an adequate amount of phosphorus so that excess phosphorus can accumulate in the walls of blood vessels leading to heart disease, their leading cause of death. A recently discovered hormone called FGF-23 helps control the blood levels of phosphorus by "telling" the kidney how much phosphorus to spill in the urine. The purpose of this study is to learn more about how FGF-23 helps the kidneys control the blood levels of phosphorus. The ultimate goal is to use this information to design improved treatment strategies for phosphorus-related problems for the millions of patients with chronic kidney disease.

Arms: arm 1: 25% of subjects will receive binders plus a phosphate restricted diet. arm 2: 25% binders + unrestricted phosphate diet. arm 3: 25% placebo + phosphate restricted diet. arm 4: 25% placebo + unrestricted phosphate diet.
Interventions: intervention 1: Lanthanum Carbonate intervention 2: Low Phosphorus Diet intervention 3: Unrestricted Phosphorus Diet intervention 4: Placebo
Intervention descriptions: intervention 1: Lanthanum carbonate 1000mg 3x/day intervention 2: Low phosphorus diet will consist of 800 mg of phosphorus per day. intervention 3: Unrestricted diet will contain 1550 mg of phosphorus per day - 800 mg of which is dietary and 750mg of Neutraphos (3 packets/day); each packet is 250mg. intervention 4: Lanthanum Carbonate placebo given three times a day with meals.

Protocol documents:
Clinical trial NCT00446966
Conditions: Atrial Fibrillation
Keywords: atrial fibrillation coronary artery disease bypass graft surgery
Sponsor: Chirag Sandesara
Start date: 2007-02-01; Completion date: 2010-01-01
Enrollment: 260 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to determine if omega-3 polyunsaturated fatty acids reduce atrial fibrillation and other outcomes after cardiac surgery. In this placebo-controlled trial, patients undergoing elective coronary artery bypass graft surgery with or without valve repair will be treated with omega-3 polyunsaturated fatty acids perioperatively. The following hypotheses will be tested: 1. omega-3 polyunsaturated fatty acids reduces the incidence of atrial fibrillation (AF) after cardiac surgery, 2. omega-3 polyunsaturated fatty acids, administered in the perioperative period for cardiac surgery, decreases postoperative complication rates, and 3. omega-3 polyunsaturated fatty acids decrease intensive care unit and hospital length-of-stay.

Detailed description:
Atrial fibrillation is the most common complication after bypass surgery. It is a significant burden to the healthcare system because it is associated with increased hospital costs and a longer hospital length-of-stay. Atrial fibrillation occurring after bypass surgery is associated with increased morbidity and mortality. Atrial fibrillation is also associated with an increased risk for strokes, use of potentially harmful drugs, and the need for pacemaker therapy.

This study is for patients who are undergoing elective bypass surgery. Patients who meet study criteria and who consent to participate in the study will be randomized to treatment with omega-3 fatty acids or matching corn oil placebo, prior to surgery. After surgery, treatment will continue until the primary endpoint, atrial fibrillation, is reached, or 14 days, whichever is first.

Arms: arm 1: Highly purified pharmaceutical grade omega three polyunsaturated fatty acids arm 2: olive oil
Interventions: intervention 1: Omega Three Polyunsaturated fatty acids
Intervention descriptions: intervention 1: 2 grams orally twice daily pre-operatively and 2 grams orally daily after until primary endpoint or 14 days.

Protocol documents:
Clinical trial NCT00477087
Conditions: Prostatic Neoplasms
Sponsor: Stanford University
Start date: 2006-07-01; Completion date: 2010-01-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of the combination of mitoxantrone and granulocyte-macrophage colony stimulating factor (GM-CSF) on progression-free survival (PFS) and overall survival (OS), in patients with hormone-refractory prostate cancer.

Detailed description:
This trial evaluates if the addition of GM-CSF to standard-of-care therapy after 1st-line docetaxel improves tumor control and survival. Because the 2 drugs have completely different mechanisms of action as well as non-overlapping metabolism, clinically significant drug-drug interactions are not anticipated, and therefore both drugs will be given at standard (approved) doses.

Arms: arm 1: GM-CSF at 250 micrograms/ m² / day subcutaneously 3 x week for 3 weeks. Participants will also receive mitoxantrone 14 mg/m² on Day 1 of each cycle. Each cycle of therapy consists 21 days.
Interventions: intervention 1: Mitoxantrone intervention 2: GM-CSF
Intervention descriptions: intervention 1: Mitoxantrone is an anti-cancer chemotherapy drug that is classified as an antitumor antibiotic. intervention 2: GM-CSF is a biologic response modifier, classified as a colony stimulating factor.

Protocol documents:
Clinical trial NCT00483561
Conditions: Prostate Cancer
Keywords: adenocarcinoma of the prostate recurrent prostate cancer stage III prostate cancer stage IV prostate cancer
Sponsor: University of Nebraska
Start date: 2004-01-01; Completion date: 2010-01-01
Enrollment: 26 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Gefitinib 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. Drugs used in chemotherapy, such as etoposide, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving gefitinib together with etoposide may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving gefitinib together with etoposide works in treating patients with advanced prostate cancer that did not respond to hormone therapy.

Detailed description:
OBJECTIVES:

Primary

* Determine the activity of gefitinib and etoposide, in terms of overall response rate, in patients with hormone-refractory advanced prostate cancer previously treated with docetaxel-based therapy.

Secondary

* Determine the toxicity of this regimen in these patients.
* Determine whether related biomarkers can help predict response in patients treated with this regimen.

OUTLINE: This is a nonrandomized study.

Patients receive oral gefitinib once daily on days 1-28 and oral etoposide once daily on days 1-14. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Patients undergo blood sample collection at baseline and periodically during study for correlative studies. Blood samples are analyzed by enzyme-linked immunosorbent assays for biomarkers (e.g., VEGF, basic fibroblast growth factor, and anti-EGFR antibody titers) in order to determine whether one or more of these biomarkers can predict response.

After completion of study therapy, patients are followed periodically.

Arms: arm 1: Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial.

Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).
Interventions: intervention 1: Gefitinib plus etoposide
Intervention descriptions: intervention 1: Gefitinib 250 mg p.o. daily, starting on Day 1and taken on a continuous basis throughout the trial with Etoposide 50 mg/m2/day for Days 1-14 out of a 28-day cycle. (Etoposide capsules come in a 50-mg dose formulation, and the patient's dose will be rounded to the nearest 50-mg multiple).

Protocol documents:
Clinical trial NCT00494871
Conditions: Atrial Fibrillation
Keywords: BAY59-7939 Rivaroxaban Non-Valvular Atrial Fibrillation Japanese Patients Phase III 12620
Sponsor: Bayer
Start date: 2007-06-01; Completion date: 2010-01-01
Enrollment: 1280 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a clinical study evaluating the efficacy and safety of rivaroxaban for stroke prevention in patients with atrial fibrillation (originally described in Japanese).

Detailed description:
Within the US 'Johnson \& Johnson Pharmaceutical Research \& Development, L.L.C.' is sponsor.

Arms: arm 1: Participants received once daily (OD) a rivaroxaban 15 mg tablet and a warfarin placebo tablet during the double-blind treatment period arm 2: Participants received OD a warfarin potassium tablet and a rivaroxaban placebo tablet during the double-blind treatment period
Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Warfarin intervention 3: Rivaroxaban placebo intervention 4: Warfarin placebo
Intervention descriptions: intervention 1: Participants orally administered rivaroxaban 15 mg OD (CrCL \[creatinine clearance\] \>= 50 mL/min) or 10 mg OD (CrCL 30-49 mL/min) intervention 2: Participants orally administered a warfarin potassium tablet (INR \[international normalized ratio\] target was 1.6-2.6 for patients \>70 years and 2.0-3.0 for patients \<70 years) intervention 3: Participants orally administered a rivaroxaban placebo tablet intervention 4: Participants orally administered a warfarin placebo tablet (adjusted based upon sham INR values)

Protocol documents: