ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00740116
Conditions: Ovarian Cancer
Keywords: Tumor of ovary Surgical blood loss Postoperative blood loss Preventive therapy Thromboembolism
Sponsor: Preben Kjolhede, MD, professor
Start date: 2008-03-01; Completion date: 2012-06-01
Enrollment: 100 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to determine if a standardized single dose tranexamic acid given intravenously immediately preoperatively reduces the perioperative bleeding volume and reduces the need of blood transfusion in women undergoing surgery for advanced ovarian cancer.

Detailed description:

Arms: arm 1: The group of women receiving Tranexamic acid intravenously immediately before the surgery arm 2: The group of women receiving saline solution (0.9% NaCl) intravenously immediately before the surgery
Interventions: intervention 1: Tranexamic acid intervention 2: 0.9% NaCl solution
Intervention descriptions: intervention 1: Tranexamic acid, 100 mg/ml; 15 mg/kg body weight added to 100 ml 0.9% NaCl solution given as a single dose intravenously immediately prior to skin incision at surgery intervention 2: 0.9% NaCl solution; 0.15 ml/kg body weight added to 100 ml 0.9% NaCl solution. The volume is given intravenously immediate before skin incision at surgery.

Protocol documents:
Clinical trial NCT00774306
Conditions: Subarachnoid Hemorrhage
Keywords: vascular risk lipid fractions lipoprotein(a) C-reactive protein subarachnoid hemorrhage antiepileptic drug randomized seizure cholesterol
Sponsor: Thomas Jefferson University
Start date: 2009-04-01; Completion date: 2012-06-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine if certain seizure medications raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes.

Detailed description:
There is some evidence that certain seizure medicines may raise levels of cholesterol and other blood components which could increase the risk of heart attacks and strokes, however, more research is needed. Individuals with acute subarachnoid hemorrhage traditionally are treated with seizure medicines, but it is not clear which one is best, or if any such medication is necessary at all.

This study is intended to find out if certain seizure medications raise levels of cholesterol and other blood components which could lead to an increased risk of heart attacks and strokes.

In this study, 200 people with acute subarachnoid hemorrhage will be randomized to treatment with one of three different seizure medicines-phenytoin, valproate, or levetiracetam-or to receive no seizure medication at all. In each participant, cholesterol and other blood markers that relate to heart attack and stroke risk will be measured shortly after hospital admission and again 8 weeks later. At the 8-week point most participants will have their seizure medication discontinued, and the same blood tests will be repeated.

Information from this study could lead to changes in how seizure medications are prescribed both in the subarachnoid hemorrhage population and in other people who are prone to seizures.

Arms: arm 1: Participants randomized to Group 1 will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. arm 2: Participants randomized to Group 2 will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses or in a once-daily extended release formulation. arm 3: Participants randomized to Group 3 will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses. arm 4: Participants randomized to Group 4 will receive no drug intervention.
Interventions: intervention 1: phenytoin intervention 2: valproate intervention 3: levetiracetam
Intervention descriptions: intervention 1: Phenytoin is a anti-seizure medication. Participants will receive phenytoin (PHT) at 5 mg/kg/day in 2 divided doses. intervention 2: Valproate is an anti-seizure medication. Participants will receive valproate (VPA) at 15 mg/kg/day in 3 divided doses. intervention 3: Levetiracetam is an anti-seizure medication. Participants will receive levetiracetam (LEV) 1000-1500 mg/day in 2 divided doses.

Protocol documents:
Clinical trial NCT00801827
Conditions: Obesity, Morbid
Keywords: Obesity Addiction PET imaging
Sponsor: Vanderbilt University Medical Center
Start date: 2007-01-01; Completion date: 2012-06-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors' (DRD2/3) and other studies have shown that obese people have less of these. We propose that low DRD2/3 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.

Detailed description:
The purpose of this study is to look at certain areas of the brain that are related to addictive behaviors, such as overeating. These areas are called 'dopamine type 2 receptors' (DRD2/3) and other studies have shown that obese people have less of these. We propose that low DRD2/3 availability seen in morbidly obese subjects will change with weight loss associated with bariatric surgery.

Arms: arm 1: Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET) scans of their brains using F-18 (fallypride), a dopamine type 2/3 (DA D2/3) receptor radioligand whose binding is sensitive to competition with endogenous dopamine, before and after the operation.
Interventions: intervention 1: F-18 (fallypride)
Intervention descriptions: intervention 1: Subjects undergoing bariatric surgery will have Positron Emission Tomography (PET)scans of their brains using the radioligand fallypride before and after the operation.

Protocol documents:
Clinical trial NCT00805740
Conditions: Candidiasis Fungemia
Keywords: Candidiasis; Invasive Candidiasis; Deep Tissue Candidiasis; Candida; Candidemia; Fungal Infection
Sponsor: Pfizer
Start date: 2009-04-01; Completion date: 2012-06-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to gather information on the use of anidulafungin for the treatment of serious Candida infection. It is expected that anidulafungin will be at least as safe and as effective as the comparator drug, caspofungin.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Active anidulafungin intervention 2: Active Caspofungin
Intervention descriptions: intervention 1: Subjects in this arm will receive active anidulafungin and placebo caspofungin intervention 2: Subjects in this arm will receive active caspofungin and placebo anidulafungin

Protocol documents:
Clinical trial NCT00837031
Conditions: Metastatic Pancreatic Cancer
Keywords: Pancreatic Pancreatic Cancer Lenalidomide Revlimid Gemcitabine
Sponsor: SCRI Development Innovations, LLC
Start date: 2009-02-01; Completion date: 2012-06-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the 6-month overall survival, safety, and tolerability of lenalidomide in combination with standard gemcitabine as first-line treatment for patients with metastatic pancreatic cancer.

Detailed description:
Because the activity of lenalidomide addresses numerous mechanisms of carcinoma growth inhibition - including, but not limited to anti-angiogenesis - lenalidomide is being evaluated as part of induction chemotherapy regimens for solid tumors. This phase II study in previously untreated metastatic pancreatic cancer is designed to establish and test the appropriate lenalidomide dose and regimen in combination with gemcitabine.

Arms: arm 1: The study began with a lead-in portion to confirm the tolerability of lenalidomide (25mg PO days 1-21) in combination with gemcitabine (1000mg/m2 IV days 1, 8, and 15).

After completion of the lead-in phase, all subsequent patients received lenalidomide 25mg PO on days 1-21 and gemcitabine 1000mg/m2 IV days 1, 8, and 15 of 28-day treatment cycles. Patients were instructed to take lenalidomide at approximately the same time each morning. Patients were permitted to continue treatment until disease progression or intolerable toxicity occurred.
Interventions: intervention 1: Lenalidomide intervention 2: Gemcitabine
Intervention descriptions: intervention 1: The starting dose of lenalidomide for the lead-in portion will be 25 mg orally daily on Days 1-21, followed by a 7-day rest period (28-day cycle). If the 25-mg dose of lenalidomide is found to be intolerable or unsafe (i.e., if more than one of the 6 patients experience a DLT), then the dose will be reduced to 20 mg orally daily, and 6 additional patients will be treated. All patients will receive lenalidomide at the confirmed tolerable dose (either 25 mg or 20 mg given orally daily on Days 1-21 of a 28-day cycle) until disease progression. If the 20-mg daily dose is found to be intolerable or unsafe, enrollment will be put on hold. intervention 2: Gemcitabine 1000 mg/m2 IV will be administered on Days 1, 8, and 15 for a 28-day cycle.

Protocol documents:
Clinical trial NCT00848016
Conditions: Recurrent Adrenocortical Carcinoma Stage III Adrenocortical Carcinoma Stage IV Adrenocortical Carcinoma
Sponsor: National Cancer Institute (NCI)
Start date: 2009-02-01; Completion date: 2012-06-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying how well gossypol acetic acid works in treating patients with recurrent, metastatic, or primary adrenocortical cancer that cannot be removed by surgery. Drugs used in chemotherapy such as gossypol acetic acid, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

Detailed description:
PRIMARY OBJECTIVE:

I. To determine the proportion of patients with recurrent, metastatic, or primary unresectable adrenocortical carcinoma who achieve an objective response to R-(-)-gossypol acetic acid.

SECONDARY OBJECTIVES::

I. To evaluate the safety of this drug in these patients. II. To determine the progression-free and overall survival of these patients.

OUTLINE: This is a multicenter study.

Patients receive oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

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

Arms: arm 1: Patients receive 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: R-(-)-gossypol acetic acid
Intervention descriptions: intervention 1: Participants take 20mg oral R-(-)-gossypol acetic acid once daily on days 1-21. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Protocol documents:
Clinical trial NCT00858780
Conditions: Rheumatoid Arthritis
Sponsor: Pfizer
Start date: 2009-01-01; Completion date: 2012-06-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study involves Rheumatoid Arthritis patients in regular clinical setting who are already on etanercept treatment and are in remission or in a low disease activity (LDA) state, and is intended to identify parameters that can serve as guidance in clinical settings. This study will consider the clinical and radiographic course in subjects when etanercept treatment is tapered or discontinued, and analyze the subjects' experience of disease worsening and the predictive values of clinical parameters, serum biomarkers and imaging on the clinical and radiographic course in different treatment groups. The effect of re-treatment with etanercept at treatment failure will also be studied.

Detailed description:

Arms: arm 1: 50mg once weekly + methotrexate arm 2: 25mg once weekly + methotrexate arm 3: once weekly + methotrexate
Interventions: intervention 1: Etanercept intervention 2: Etanercept intervention 3: Placebo
Intervention descriptions: intervention 1: 50 mg etanercept once weekly + methotrexate intervention 2: 25mg etanercept once weekly + methotrexate intervention 3: Placebo comparator once weekly + methotrexate

Protocol documents:
Clinical trial NCT00866723
Conditions: Ovarian Cancer Primary Peritoneal Serous Cancer Fallopian Tube Cancer
Keywords: Avastin bevacizumab
Sponsor: Beth Israel Deaconess Medical Center
Start date: 2009-03-01; Completion date: 2012-06-01
Enrollment: 5 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate how the participant's disease (ovarian, primary peritoneal serous, fallopian tube, or papillary serous endometrial cancer) responds to additional treatment with Avastin (bevacizumab). Participants have already received Avastin as part of maintenance therapy for their cancer. Maintenance therapy is a medical therapy that is given to people to prevent a relapse. However, cancer may return after maintenance therapy. This research study hopes to determine whether additional treatment with Avastin will be effective in treating the participant's cancer.

Detailed description:
OBJECTIVES:

Primary:

To determine the activity of bevacizumab in patients with epithelial ovarian, primary peritoneal serous, papillary serous endometrial or fallopian tube cancer who relapse after achieving an initial complete response to first-line therapy that included at least 6 month bevacizumab maintenance as defined by: 1) clinical response rate OR 2) clinical benefit response

Secondary:

* To assess duration of progression free survival (PFS)
* To assess the safety
* To correlate response with the Avastin-free interval

STATISTICAL DESIGN:

This study used a two-stage design to evaluate efficacy of bevacizumab based on a patient achieving either clinical response or clinical benefit response. The null and alternative response rates were 10% and 30%. If two or more patients enrolled in the stage one cohort (n=10 patients) achieved response than accrual would proceed to stage two (n=19 patients). If response was achieved by at least 6 patients in the final set of 29 evaluable patients then bevacizumab would be deemed worthy for further study. This design had 80% power given one-sided 0.05 significance level.

Arms: arm 1: Bevacizumab was administered at 15 mg/kg intravenously every 3 weeks. Treatment continued until disease progression or unacceptable toxicity.
Interventions: intervention 1: bevacizumab
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00873041
Conditions: Non-transfusion Dependent Thalassemia
Keywords: Thalassemia thalassemia intermedia alpha-thalassemia beta-thalassemia deferasirox iron overload non-transfusion dependent
Sponsor: Novartis Pharmaceuticals
Start date: 2008-11-01; Completion date: 2012-06-01
Enrollment: 166 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
CICL670A2209: This study will evaluate the safety and efficacy of deferasirox in non-transfusion dependent thalassemia patients with iron overload. Patients will be treated either with active treatment (deferasirox) or placebo for 12 months (core study phase). Patients who complete the core study phase will be offered to continue their study with the active treatment (deferasirox) in a 12 months extension phase. During the core and extension, the effects of treatment on iron overload in the liver will be evaluated using magnetic resonance imaging (MRI) assessments.

CICL670A2209E1: A one-year open-label extension to a randomized, double-blind, placebo-controlled, phase II study to evaluate efficacy and safety of deferasirox in non-transfusion dependent thalassemia patients with iron overload (Thalassa).

Detailed description:

Arms: arm 1: Participants received a starting dose of 5 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. arm 2: Participants received a starting dose of 10 mg/kg/day deferasirox tablets orally each day in the morning for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. arm 3: Placebo tablet matching 5 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks. arm 4: Placebo tablet matching 10 mg/kg/day orally in the morning each day for 52 weeks. After 24 weeks of treatment Liver Iron Concentration (LIC) was assessed. Based on the LIC and change from baseline in LIC participants were eligible for dose escalation. In the Extension Study participants received deferasirox once daily (dose based on LIC) for 52 weeks.
Interventions: intervention 1: deferasirox intervention 2: placebo
Intervention descriptions: intervention 1: Supplied as 125 mg, 250 mg and 500 mg tablets. intervention 2: Supplied as matching 125 mg, 250 mg and 500 mg tablets.

Protocol documents:
Clinical trial NCT00875615
Conditions: Liver Cancer
Keywords: adult primary hepatocellular carcinoma localized unresectable adult primary liver cancer advanced adult primary liver cancer
Sponsor: University of Miami
Start date: 2008-12-01; Completion date: 2012-06-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as cisplatin and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Sorafenib 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. Infusing chemotherapy directly into the liver and giving it together with sorafenib may kill more tumor cells.

PURPOSE: This phase II trial is studying the side effects of infusing cisplatin or carboplatin directly into the liver and giving it together with sorafenib in treating patients with liver cancer that cannot be removed by surgery.

Detailed description:
OBJECTIVES:

Primary

* To assess the safety of intrahepatic arterial infusion of cisplatin or carboplatin in combination with sorafenib tosylate in patients with unresectable hepatocellular carcinoma.

Secondary

* To assess the time to tumor progression in patients treated with this regimen.
* To assess the overall and progression-free survival of patients treated with this regimen.

OUTLINE: Patients receive intrahepatic arterial infusion of cisplatin or carboplatin over 30-45 minutes on day 1 and oral sorafenib tosylate twice daily on days 8-35. Treatment repeats every 42 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically.

Arms: arm 1: None
Interventions: intervention 1: Carboplatin intervention 2: Cisplatin intervention 3: Sorafenib
Intervention descriptions: intervention 1: Carboplatin AUC =6 at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. intervention 2: Cisplatin 60 m/m² via percutaneous intrahepatic (IA) artery infusion at the investigator's discretion. Treatment is given every 6 weeks for up to 12 Cycles. intervention 3: Sorafenib 400 mg po bid daily starting on Day 1 (± up to 3 days) continuously.

Protocol documents:
Clinical trial NCT00876928
Conditions: Pre-diabetes
Keywords: pre-diabetes minorities oral glucose tolerance test disposition index insulin secretion insulin sensitivity diabetes
Sponsor: Charles Drew University of Medicine and Science
Start date: 2009-03-01; Completion date: 2012-06-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Vitamin D supplementation in minority subjects with both pre-diabetes and low vitamin D levels will delay the development of diabetes.

Detailed description:
Low vitamin D levels 1) are associated with abnormalities in insulin secretion and insulin action, 2) predict the development of diabetes in those without diabetes, and 3) are more common in people with diabetes. Minority populations (African-Americans and Latinos) are more likely to have both low levels of vitamin D and diabetes. This study will identify minority individuals who are at increased risk for diabetes (those with central obesity, family history of diabetes in first degree relatives and either with hypertension or being treated for hypertension), and determine if they have both pre-diabetes, ie, impaired fasting glucose and/or impaired glucose tolerance, and low levels of vitamin D. Those that have both will be randomized to either high doses of vitamin D or placebo and insulin secretion and action as well as changes in the oral glucose tolerance test (reversion to normal, maintenance of pre-diabetes or development of diabetes) will be monitored at 3 month intervals for one year. This study will test the hypothesis that the increased amount of diabetes in minority populations may be due in part to low levels of vitamin D and whether supplementing this vitamin may delay the development of diabetes.

Arms: arm 1: Subjects with low vitamin D levels and pre-diabetes arm 2: Subjects with low vitamin D levels and pre-diabetes
Interventions: intervention 1: vitamin D intervention 2: placebo
Intervention descriptions: intervention 1: liquid vitamin D3 dissolved in medium chain triglyceride once a week intervention 2: medium chain triglyceride given once per week

Protocol documents:
Clinical trial NCT00880685
Conditions: Kleptomania
Keywords: Compulsive Stealing Compulsive Shoplifting
Sponsor: University of Chicago
Start date: 2009-03-01; Completion date: 2012-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of the proposed study is to evaluate the efficacy and safety of memantine in kleptomania.

Detailed description:
The proposed study will consist of 8 weeks of treatment with memantine in 10 subjects with kleptomania. The hypothesis to be tested is that memantine will be effective in reducing the urges to steal in patients with kleptomania. The proposed study will provide needed data on the treatment of a disabling disorder that currently lacks a clearly effective treatment.

Arms: arm 1: Memantine 10-30mg
Interventions: intervention 1: Memantine
Intervention descriptions: intervention 1: 10-30mg, daily for 8 weeks

Protocol documents: