ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01216072
Conditions: Relapsing Forms of Multiple Sclerosis
Keywords: Relapsing Forms of Multiple Sclerosis Disease Modifying Therapy fingolimod Patient Reported Outcomes
Sponsor: Novartis Pharmaceuticals
Start date: 2010-08-01; Completion date: 2012-08-01
Enrollment: 1053 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.

Detailed description:

Arms: arm 1: Patients randomized in this arm received Fingolimod 0.5 mg/day oral capsule for 6 months core period . arm 2: Patients randomized in this arm received selected Standard MS DMT such as Interferon beta-1b or Interferon beta-1a or Glatiramer acetate for 6 months. An open-label extension of up to 3 months of treatment with fingolimod was to be available for patients in the DMT arm who successfully completed all study visits.
Interventions: intervention 1: Fingolimod intervention 2: Standard MS DMTs
Intervention descriptions: intervention 1: 0.5 mg/day oral capsule intervention 2: None

Protocol documents:
Clinical trial NCT01284517
Conditions: Bipolar Depression
Keywords: Bipolar I Depression Lurasidone Latuda
Sponsor: Sumitomo Pharma America, Inc.
Start date: 2010-11-01; Completion date: 2012-08-01
Enrollment: 356 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Lurasidone HCI is a compound that is a candidate for the treatment of bipolar I depression. This clinical study is designed to test the hypothesis that Lurasidone in combination with either Lithium or Divalproex is effective among patients with bipolar I depression.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Lurasidone intervention 2: Placebo
Intervention descriptions: intervention 1: Tablets 20-120 mg, PM dosing,daily for 6 weeks intervention 2: Equivalent to Lurasidone dosing

Protocol documents:
Clinical trial NCT01432457
Conditions: Major Depressive Disorder
Sponsor: Pfizer
Start date: 2011-10-01; Completion date: 2012-08-01
Enrollment: 924 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A multicenter, 8-week study to evaluate the efficacy of 2 doses (50 and 100 mg/day) of desvenlafaxine succinate sustained-release (DVS SR) versus placebo in adult outpatients with major depressive disorder.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: desvenlafaxine succinate sustained-release 50 mg/day intervention 2: desvenlafaxine succinate sustained-release 100 mg/day intervention 3: placebo
Intervention descriptions: intervention 1: 50 mg tablets of DVS SR taken orally once daily for 8 weeks; 1 week of placebo taper intervention 2: 100 mg tablets of DVS SR taken orally once daily for 8 weeks (which includes 1 week of titration at 50 mg/day); 1 week of taper at 50 mg/day intervention 3: 50 mg and 100 mg placebo matching tablets taken orally once daily for 8 weeks; 1 week of placebo taper

Protocol documents:
Clinical trial NCT00010257
Conditions: Thymoma Thymic Carcinoma
Keywords: thymoma thymic carcinoma
Sponsor: Eastern Cooperative Oncology Group
Start date: 2001-06-19; Completion date: 2012-08-01
Enrollment: 46 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one chemotherapy drug may kill more tumor cells.

PURPOSE: Phase II trial to study the effectiveness of carboplatin combined with paclitaxel in treating patients who have advanced thymoma.

Detailed description:
OBJECTIVES:

* Determine the objective response rate in patients with advanced thymoma or thymic carcinoma treated with carboplatin and paclitaxel.
* Determine the duration of response in these patients treated with this regimen.
* Determine the toxicity of this regimen in these patients.

OUTLINE: Patients receive paclitaxel by intravenous (IV) infusion over 3 hours followed by carboplatin IV over 30 minutes on day 1. Treatment repeats every 21 days for 2 courses in the absence of disease progression. Patients achieving complete or partial remission or stable disease receive 4 additional courses of therapy for a maximum of 6 courses. Further treatment may be given at the discretion of the treating physician.

Patients were followed every 3 months for 2 years, every 6 months for 3 years, and then annually thereafter.

PROJECTED ACCRUAL: A total of 35-68 patients were to be accrued for this study within 3.8-4.6 years.

Arms: arm 1: Paclitaxel 225 mg/m2 IV over 3 hours and Carboplatin AUC 6.0 IV over 30 minutes on day 1 of a 21-day cycle
Interventions: intervention 1: carboplatin intervention 2: paclitaxel
Intervention descriptions: intervention 1: Dosed to AUC of 6.0, given IV over 30 minutes day 1 of a 21-day cycle, for up to 6 cycles intervention 2: 225 mg/m2 given by intravenous (IV) infusion over 3 hours on day 1 of a 21-day cycle, for up to 6 cycles

Protocol documents:
Clinical trial NCT00044213
Conditions: Coronary Artery Disease
Sponsor: Mt. Sinai Medical Center, Miami
Start date: 2003-09-01; Completion date: 2012-08-01
Enrollment: 1708 participants; Allocation: RANDOMIZED; Intervention model: FACTORIAL

Brief summary:
The purpose of this study is to determine the safety and effectiveness of ethylene diamine tetra-acetic (EDTA) chelation therapy in individuals with coronary artery disease.

Detailed description:
EDTA chelation therapy involves repeated administrations of a synthetic amino acid to reduce atherosclerotic plaque and other mineral deposits throughout the cardiovascular system.

Participants will be randomly assigned to receive 40 infusions of either the standard chelation solution or placebo. The primary endpoint of this trial will be a composite of all cause mortality, myocardial infarction, stroke, coronary revascularization, and hospitalization for angina.

The results of TACT will provide either a significant positive result or an informative null result upon which rational clinical decision-making and health policy can be based.

Arms: arm 1: Participants will receive 40 infusions of active EDTA chelation and active high-dose oral vitamins. arm 2: Participants will receive 40 infusions of EDTA chelation and placebo high-dose oral vitamins. arm 3: Participants will receive 40 infusions of placebo EDTA chelation and active high-dose oral vitamins. arm 4: Participants will receive 40 infusions of placebo EDTA chelation and placebo high-dose oral vitamins.
Interventions: intervention 1: EDTA intervention 2: EDTA Placebo intervention 3: High Dose Vitamin intervention 4: High Dose Vitamin Placebo
Intervention descriptions: intervention 1: Participants will receive 40 infusions of standard chelation solution. intervention 2: Participants will receive 40 infusions of EDTA placebo. intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT00062010
Conditions: Lung Cancer
Keywords: recurrent small cell lung cancer
Sponsor: Eastern Cooperative Oncology Group
Start date: 2004-05-26; Completion date: 2012-08-01
Enrollment: 37 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as paclitaxel, work in different ways to stop tumor cells from dividing so they stop growing or die. Some tumors become resistant to chemotherapy drugs. Giving interferon alfa and isotretinoin together with paclitaxel may reduce resistance to the drug and allow the tumor cells to be killed.

PURPOSE: This phase II trial is studying how well giving interferon alfa and isotretinoin together with paclitaxel works in treating patients with recurrent small cell lung cancer.

Detailed description:
OBJECTIVES:

* Determine the frequency and duration of response in patients with recurrent small cell lung cancer treated with interferon alfa, isotretinoin, and paclitaxel.
* Determine the toxic effects of this regimen in these patients.
* Determine the duration of survival in patients treated with this regimen.
* Correlate the levels of bcl-2 in peripheral blood monocytes with response and survival in patients treated with this regimen.

OUTLINE: This is a multicenter study.

Patients receive interferon alfa subcutaneously and oral isotretinoin on days 1 and 2 and paclitaxel IV over 1 hour on day 2 of weeks 1-6. Courses repeat every 8 weeks in the absence of disease progression or unacceptable toxicity.

Patients are followed every 3 months for 2 years and then every 6 months for 1 year.

PROJECTED ACCRUAL: A total of 37-83 patients will be accrued for this study.

Arms: arm 1: Interferon alpha: 6 million U/m2 on days 1 and 2 of each week for 6 weeks of an 8-week cycle 13-cis-retinoic acid: 1 mg/kg on days 1 and 2 of each week for 6 weeks of an 8-week cycle Paclitaxel: 75 mg/m2 on day 2 of each week for 6 weeks of an 8-week cycle
Interventions: intervention 1: interferon alpha intervention 2: 13-cis-retinoic acid intervention 3: paclitaxel
Intervention descriptions: intervention 1: Interferon alpha given subcutaneously, 6 million units per square meter of body surface area on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity. intervention 2: 13-cis-retinoic acid given at 1 mg/kg of body weight by mouth on days 1 and 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity. intervention 3: paclitaxel administered intravenously with premedication at 75 mg/m2 of body surface area on day 2 of each week for 6 weeks, followed by 2 weeks of rest. Given until disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00091507
Conditions: Angina, Unstable Cardiovascular Diseases Heart Diseases Coronary Disease Myocardial Infarction Heart Failure, Congestive
Keywords: Acute Coronary Syndrome
Sponsor: Tufts Medical Center
Start date: 2006-11-01; Completion date: 2012-08-01
Enrollment: 911 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the impact of pharmacological myocardial metabolic support, in the form of intravenous (IV) glucose, insulin and potassium (GIK), for the treatment of patients with threatened or established acute myocardial infarction (AMI).

Detailed description:
BACKGROUND:

Basic and clinical research suggests intravenous GIK metabolic myocardial support reduces ischemia-induced arrhythmias, progression from unstable angina pectoris (UAP) to acute myocardial infarction (AMI), myocardial infarction (MI) size, and mortality. Also, for ST elevation MI (STEMI), GIK may prolong time of benefit of coronary reperfusion. These effects should reduce short- and long-term mortality from ACS, including AMI and UAP, and the propensity for heart failure (HF). These benefits are related to the earliness of ACS, when both risk and opportunity to save lives are highest.

DESIGN NARRATIVE:

This is a randomized, placebo-controlled, double-blinded, multicenter clinical trial of IMMEDIATE GIK as early as possible in ACS in the prehospital emergency medical service (EMS) setting. Distinct from prior and ongoing GIK trials, this will test GIK for all ACS rather than only for AMI or STEMI in prehospital EMS. The primary hypothesis is that early GIK will prevent or reduce the size of acute myocardial infarction. Major secondary hypotheses posit GIK will reduce mortality (30 days and 1 year), reduce pre- or in-hospital cardiac arrest and the propensity for heart failure. Other hypotheses address mechanisms of these effects.

Arms: arm 1: GIK = glucose-insulin-potassium; In one-liter: Dextrose 30% + 80 mEq Potassium Chloride + 50 units Regular Insulin; infused at 1.5 ml/kg/hour for a total of 12 hours. arm 2: Dextrose 5%, infused at 1.5 ml/kg/hour for total of 12 hours.
Interventions: intervention 1: GIK intervention 2: Placebo
Intervention descriptions: intervention 1: Intravenous solution, 1.5ml/kg/hour, continuous infusion for total of 12 hours. intervention 2: Intravenous solution of Dextrose 5 percent at 1.5 ml/kg/hour for a total of 12 hours.

Protocol documents:
Clinical trial NCT00108355
Conditions: Ascites Cirrhosis
Keywords: albumin ascites paracentesis
Sponsor: US Department of Veterans Affairs
Start date: 2003-12-01; Completion date: 2012-08-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This clinical trial compares a combination of two drugs that constrict blood vessels (Octreotide LAR and Midodrine) to albumin after large volume paracentesis. Subjects have cirrhosis and ascites.

Detailed description:
This prospective, placebo-controlled, randomized, clinical trial compares the effect of a combination of vasoconstrictors (octreotide plus midodrine) to albumin on the time to recurrence of ascites in patients with refractory ascites treated with large volume paracentesis. The treatment allocation ratio for the two treatment arms is 1:1 using a stratified random permuted block design. Subjects are patients 18-80 years old with cirrhosis and ascites who are stratified according to the presence or absence of renal dysfunction at the time of randomization. Measurements include blood pressure, weight, girth, abdominal ultrasound, forearm blood flow, plasma renin activity, angiotensin, and aldosterone, repeated during a 6 month period.

Arms: arm 1: After LVP, patients in this group received:

Intravenous albumin (25%) at 8 g/liter of ascitic fluid removed, one time dose; Intramuscular injection of 5 cc saline (Octreotide LAR placebo), every 30 days ; Oral tablet 3 times a day (Midodrine placebo) arm 2: After LVP, patients in this group received:

Octreotide LAR intramuscular injection 20 mg, every 30 days; Midodrine tablet, 10 mg three times a day; Intravenous saline infusion (Albumin placebo), one time dose
Interventions: intervention 1: Albumin intervention 2: Intravenous Saline Infusion (Albumin placebo) intervention 3: Midodrine intervention 4: Oral tablet (Midodrine placebo) intervention 5: Octreotide LAR intervention 6: Saline injection (Octreotide LAR placebo) intervention 7: Large Volume Paracentesis
Intervention descriptions: intervention 1: Intravenous Albumin at a dose of 8g/liter of ascitic fluid removed intervention 2: Intravenous saline Infusion (Albumin placebo) intervention 3: Midodrine oral tablet at 10 mg three times a day. intervention 4: Oral tablet (Midodrine placebo) three times a day intervention 5: Octreotide LAR 20 mg intramuscular injection every 30 days intervention 6: Saline intramuscular injection 5 cc every 30 days. intervention 7: Procedure to remove large amounts (more than 5 liter) of ascitic fluid via a catheter.

Protocol documents:
Clinical trial NCT00131937
Conditions: Anaplastic Large Cell Lymphoma Angioimmunoblastic T-cell Lymphoma Hepatosplenic T-cell Lymphoma Peripheral T-cell Lymphoma Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Adult Immunoblastic Large Cell Lymphoma Recurrent Adult T-cell Leukemia/Lymphoma Recurrent Cutaneous T-cell Non-Hodgkin Lymphoma
Sponsor: National Cancer Institute (NCI)
Start date: 2005-10-01; Completion date: 2012-08-01
Enrollment: 14 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well sorafenib works in treating patients with recurrent diffuse large B-cell non-Hodgkin's lymphoma. Sorafenib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

Detailed description:
PRIMARY OBJECTIVES:

I. To evaluate the response rate of treatment with sorafenib (BAY43-9006) in patients with recurrent aggressive non-Hodgkin's lymphomas.

SECONDARY OBJECTIVES:

I. To evaluate the duration of response and progression free survival of treatment with BAY43-9006 in patients with recurrent aggressive Non-Hodgkin's Lymphomas.

II. To characterize the toxicity of treatment with BAY43-9006 in patients with recurrent aggressive Non-Hodgkin's Lymphomas.

III. To further characterize the pharmacokinetics properties of BAY43-9006 and assess influence of monooxygenases polymorphisms and multi-drug resistance transporter (MDR) on pharmacokinetics.

OUTLINE: This is a multicenter study.

Patients receive oral sorafenib twice 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 every 3 months for 2 years and then every 6 months for 1 year.

PLANNED ACCRUAL: 41 ACTUAL ACCRUAL: 14

Arms: arm 1: Patients receive oral sorafenib 400 mg PO twice daily on days 1-28. Courses repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: sorafenib tosylate
Intervention descriptions: intervention 1: Given orally

Protocol documents:
Clinical trial NCT00140621
Conditions: Fabry Disease
Keywords: cardiac fabry disease
Sponsor: Genzyme, a Sanofi Company
Start date: 2005-07-01; Completion date: 2012-08-01
Enrollment: 6 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a multi-center, open label, phase IV study conducted to evaluate the efficacy and safety of agalsidase beta (Fabrazyme \[recombinant form\]) administered by intravenous drip infusion in participants with cardiac Fabry disease.

Participants participated for 4 weeks or less in the baseline period and 156 weeks for the treatment period.

Detailed description:

Arms: arm 1: Agalsidase beta 1 milligram per kilogram (mg/kg) intravenously once every 2 weeks up to 156 weeks.
Interventions: intervention 1: Agalsidase beta
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00231465
Conditions: Non-Small Cell Lung Cancer
Keywords: elderly malignant pleural effusion
Sponsor: H. Lee Moffitt Cancer Center and Research Institute
Start date: 2003-07-01; Completion date: 2012-08-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II, open-label trial of Taxotere® + ZD1839 in elderly patients with Stage III-b or IV NSCLC who have received no prior chemotherapy for metastatic disease. Patients with prior adjuvant chemotherapy were allowed to enroll on this trial.

Detailed description:
This trial is designed to test the efficacy and tolerability of a standard chemotherapy agent, Docetaxel, in combination with an oral agent, Iressa, in elderly patients with advanced stage lung cancer. Current practices utilize two chemotherapeutic medications that may result in increased toxicities and poor outcomes in the elderly population. Treatment consists of an infusion of docetaxel every 21 days for four doses while taking Iressa every day. A computed tomography (CT) scan will measure disease response after two cycles. Response determines continuation of treatment. Lab work will be collected before every treatment. Side effect information will also be collected at every visit. Once the infusion phase of the study is completed, a maintenance phase of taking just the Iressa begins and disease assessment occurs every two months. This period will last until disease progression is demonstrated.

Arms: arm 1: Patients will receive Taxotere at 75 mg/m2 given IV over 60 minutes on day 1 of a three week cycle.

ZD1839 will be administered orally at 250mg daily starting on day one, concurrently with the Taxotere.
Interventions: intervention 1: docetaxel (Taxotere®) intervention 2: ZD1839
Intervention descriptions: intervention 1: Taxotere® will be administered to patients a maximum of 2 cycles, after a maximal response is achieved, and then discontinued. intervention 2: ZD1839 will be continued until progression, or until trial closure, whichever comes first.

Protocol documents:
Clinical trial NCT00256282
Conditions: Metastatic Melanoma
Keywords: Metastatic Melanoma
Sponsor: John P. Fruehauf
Start date: 2003-04-01; Completion date: 2012-08-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a Phase II Evaluation of Docetaxel and Vinorelbine Plus Sargramostim in subjects who have metastatic melanoma which has advanced beyond the point at which local therapies such as surgery or radiation therapy would be helpful. Without effective treatment, metastatic melanoma is usually a severe and fatal disease. Chemotherapy agents or combinations of chemotherapy agents have produced tumor shrinkage in some patients, which has occasionally persisted. This research involves treatment with a combination of chemotherapy drugs known to be active against melanoma alone. The investigational purpose of this study is to determine if the combination of docetaxel, vinorelbine and sargramostim will produce a response (complete or partial) in metastasis melanoma. The researchers also wants to find out what side effects are associated with this combination of drugs.

Detailed description:
Annually in the U.S. there is an estimated 40,000 new cases of malignant melanoma and 7000 deaths. This disease is becoming more common with its incidence increasing at a more rapid rate in the past decade than that of any other cancer except lung cancer in women. Metastatic disease responds poorly to the usual treatments with only 2 out of 30 drugs tested, DTIC and nitrosoureas, showing response rates greater than 10%. Complete responses are rare.

Metastatic melanoma is a disease with few therapeutic options. Multi-agent chemotherapy with cisplatin (CDDP), Dacarbazine (DTIC), Carmustine (BCNU), with or without Tamoxifen, offers a 20% response rate but has failed to consistently demonstrate a significant improvement in overall survival (OS) or disease-free survival (DFS) when compared to a single agent DTIC.

Recently, investigators, in an effort to combine the activity of biologic response modifiers with chemotherapy, have developed combination biochemotherapy for metastatic melanoma. Legha et al reported an overall objective response rate of 64% with a 5-day biochemotherapy regimen. O'Day et al reported similar results (overall response rate of 57%) using a modified 5-day biochemotherapy regimen.

The above regimens all have significant toxicities and modest response rates. Clearly, more effective less toxic regimens are needed.

Vinorelbine tartrate (Navelbine) and Docetaxel (Taxotere) have both shown activity against melanoma. Additionally, the combination of both drugs has shown enhanced activity against melanoma.

Arms: arm 1: Docetaxel, Vinorelbine, and Sargramostim
Interventions: intervention 1: Vinorelbine intervention 2: Docetaxel intervention 3: Sargramostim
Intervention descriptions: intervention 1: 30 mg/m2 IV over 6-10 min every 14 days intervention 2: 40mg/m2 IV over 1 hour every 14 days intervention 3: 250 mcg/m2 subcutaneous (SQ) daily (QD) x 10 days

Protocol documents: