ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00225147
Conditions: Hereditary Angioedema Angioneurotic Edema
Sponsor: Pharming Technologies B.V.
Start date: 2005-07-01; Completion date: 2010-01-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Hereditary angioedema ("HAE") is a genetic disorder characterized by sudden recurrent attacks of local swelling (angioedema). These attacks are often painful and disabling, and, in some cases, life-threatening. "HAE" is caused by mutations in the "C1INH" gene that lead to a decrease in the blood level of functional "C1INH". This multi-center study was designed to assess the safety and tolerability, efficacy, and pharmacokinetics/pharmacodynamics of recombinant human C1 inhibitor ("rhC1INH") in the treatment of acute hereditary angioedema attacks.

Funding Source - FDA OOPD

Detailed description:
A prospectively planned interim analysis will be performed on the double-blind data.

Arms: arm 1: 100 IU/kg Recombinant human C1 inhibitor arm 2: 50 IU/kg Recombinant human C1 inhibitor arm 3: None
Interventions: intervention 1: Recombinant Human C1 Inhibitor intervention 2: placebo
Intervention descriptions: intervention 1: IV intervention 2: saline solution

Protocol documents:
Clinical trial NCT00231894
Conditions: Diabetes Schizophrenia Insulin Resistance Cognitive Impairment
Keywords: atypical antipsychotics hyperglycemia triglycerides HDL cholesterol insulin resistance schizophrenia verbal memory
Sponsor: Nathan Kline Institute for Psychiatric Research
Start date: 2005-05-01; Completion date: 2010-01-01
Enrollment: 56 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study with an approved drug for treating type 2 diabetes, for its effects on treating glucose and lipid abnormalities in patients being treated with first or second-generation antipsychotics, and comparison of effects of this drug with another treatment lifestyle modification. Patients who meet inclusion criteria will be treated with pioglitazone for 12 weeks. They will be evaluated for fasting glucose and lipids, glucose-tolerance tests, and neurocognitive battery and tests of verbal memory at baseline and during treatment with pioglitazone.

Detailed description:
The aim of this study is to investigate the effects of pioglitazone added to weight-lifestyle intervention vs. placebo plus lifestyle intervention on reversing or reducing impaired or abnormal triglycerides, HDL and glucose metabolism in schizophrenics treated with first or second-generation antipsychotics.. Another aim is to examine the effects of impaired glucose metabolism on verbal memory and other cognitive function in schizophrenic patients treated with these medications and the relationship to improvements in impaired glucose metabolism to impairments in cognitive function. Clozapine and olanzapine, and some other first or second-generation antipsychotics effective for treating schizophrenia and bipolar disorders, have been reported to be associated with increased incidence of diabetic type metabolic abnormalities, decreases in insulin sensitivity, and abnormal glucose tolerance tests. This can lead to the development of type 2 diabetes and also abnormal lipid metabolic levels which can lead to atherosclerotic changes and increased risk of cardiovascular disease and other diabetes related complications. Drug treatments which could reduce or correct these diabetic metabolic changes would permit many patients to continue to receive the benefits of these antipsychotic medications with reduced drug-induced comorbidity. Previous research using non-psychotic subjects has shown that diabetes and impaired glucose tolerance are associated with cognitive impairments, especially in verbal memory, and provides a rationale for testing whether corrections of impaired glucose metabolism are associated with cognitive improvements in schizophrenic patients.

Arms: arm 1: Pioglitazone (30-45 mg/daily) plus life-style diet group arm 2: Placebo capsules daily plus life-style diet group
Interventions: intervention 1: Pioglitazone intervention 2: Life style diet group intervention 3: Placebo
Intervention descriptions: intervention 1: pioglitazone 30-45 mg/day intervention 2: life style diet education group 1x/week intervention 3: placebo comparator capsules

Protocol documents:
Clinical trial NCT00290407
Conditions: Leukemia, Lymphocytic, Chronic Lymphoma, Small Lymphocytic
Keywords: chronic lymphocytic leukemia small lymphocytic lymphoma rituximab beta-glucan
Sponsor: University of Louisville
Start date: 2006-03-01; Completion date: 2010-01-01
Enrollment: 2 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine how well subjects respond to treatment with Rituximab plus Beta-Glucan.

Detailed description:
Chronic lymphocytic leukemia (CLL) is the most common form of leukemia in adults. CLL is a cancer of the B-lymphocytes, which make antibodies that help protect the body against harmful foreign substances, such as bacteria and viruses. Similar to CLL, small lymphocytic lymphoma (SLL) is a less-common cancer of the B-lymphocytes. In SLL, the abnormal lymphocytes mainly affect the lymph nodes; in CLL, the abnormal lymphocytes mainly affect the blood and bone marrow.

Current drug therapies for CLL/SLL are known to increase the severity of pre-existing low blood cell counts, which in turn increase the risk of infections in patients. Research to improve the safety and effectiveness of CLL/SLL therapy is currently ongoing. One such therapy being investigated is Rituximab.

Rituximab is a type of drug known as a therapeutic antibody. Therapeutic antibodies are laboratory-created substances that attach onto a protein on the surface of a cell. After binding to the cell, the therapeutic antibody can block the growth of the tumor and/or trigger the body's immune system to attack the target, and can also sensitize a cancer cell to chemotherapy. Rituximab is approved by the Food and Drug Administration (FDA) for the treatment of CLL/SLL.

Beta-Glucan (Imucell WGP) is an over-the-counter dietary supplement that enhances the body's immune system. ImucellTM WGP is extracted from food-grade baker's yeast, which is permitted for use in food by the FDA. Animal studies have shown that Imucell WGP helps trigger the white blood cells to destroy cancer cells. Other animal studies combining Rituximab with Imucell WGP have shown greater tumor regression and tumor-free survival.

Interventions: intervention 1: Rituximab intervention 2: Beta-Glucan
Intervention descriptions: intervention 1: 375 mg/m2, IV (in the vein), once a week for 4 weeks intervention 2: 250 mg, orally (tablet), three times a day for 9 weeks

Protocol documents:
Clinical trial NCT00299689
Conditions: Malignant Melanoma
Keywords: Melanoma Metastatic Stage IV Ontak
Sponsor: James Graham Brown Cancer Center
Start date: 2006-03-01; Completion date: 2010-01-01
Enrollment: 69 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether ONTAK is an effective treatment in patients with Stage IV Melanoma

Detailed description:
This is a Phase II clinical trial to determine whether administration of ONTAK will result in a significant response rate in patients with metastatic melanoma.

Although the development of effective immunotherapy and the characterization of multiagent chemotherapy regimens have substantially improved in the treatment of metastatic malignant melanoma, the overall results remain dismal with a 6% five year survival rate for stage IV disease. Of the common adult-onset cancers, melanoma is widely held to be the most amenable to immunological intervention.

The primary objective of this study is to determine the response rate and the overall survival of patients with metastatic malignant melanoma treated with two regimens of ONTAK.

Arms: arm 1: Single-arm: Ontak
Interventions: intervention 1: Denileukin diftitox
Intervention descriptions: intervention 1: 12 mcg/kg IV (in vein) over 30 minutes on days 1 through 4 of each 21 day cycle for 4 cycles.

Protocol documents:
Clinical trial NCT00305773
Conditions: Adult Acute Erythroid Leukemia (M6) 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 Myeloid Leukemia With 11q23 (MLL) Abnormalities Adult Acute Myeloid Leukemia With Inv(16)(p13;q22) Adult Acute Myeloid Leukemia With t(15;17)(q22;q12) Adult Acute Myeloid Leukemia With t(16;16)(p13;q22) Adult Acute Myeloid Leukemia With t(8;21)(q22;q22) Adult Acute Myelomonocytic Leukemia (M4) Adult Acute Promyelocytic Leukemia (M3) Recurrent Adult Acute Myeloid Leukemia Refractory Cytopenia With Multilineage Dysplasia Secondary Acute Myeloid Leukemia Untreated Adult Acute Myeloid Leukemia
Sponsor: National Cancer Institute (NCI)
Start date: 2006-01-01; Completion date: 2010-01-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Vorinostat may stop the growth of cancer cells by blocking some of the enzymes needed for their growth. Giving the drug in different ways may kill more cancer cells. This randomized phase II trial is studying two different schedules of vorinostat to see how well they work in treating patients with acute myeloid leukemia.

Detailed description:
PRIMARY OBJECTIVES:

I. Determine the toxicity and the proportion of complete remissions associated with two different treatment schedules of vorinostat (SAHA) in patients with acute myeloid leukemia.

SECONDARY OBJECTIVES:

I. Determine the toxic effects of SAHA in this study population. II. Examine for preliminary evidence of re-expression of silenced genes in leukemic blasts in response to SAHA.

OUTLINE: This is a multicenter, randomized study. Patients are stratified according to disease status (relapsed vs untreated). Patients are randomized to 1 of 2 treatment arms.

ARM I: Patients receive oral vorinostat (SAHA) once a day on days 1-21. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

ARM II: Patients receive oral SAHA three times a day on days 1-14. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed periodically for up to 2 years.

PROJECTED ACCRUAL: A total of 44 patients will be accrued for this study.

Arms: arm 1: Patients receive oral vorinostat (SAHA) once a day on days 1-21. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity. arm 2: Patients receive oral SAHA three times a day on days 1-14. In both arms, treatment repeats every 21 days for up to 17 courses in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: vorinostat intervention 2: vorinostat
Intervention descriptions: intervention 1: Given orally once daily intervention 2: Given orally three times daily

Protocol documents:
Clinical trial NCT00320190
Conditions: Leukemia, Myeloid, Chronic
Keywords: Chronic phase CML, with a suboptimal response after treatment with imatinib
Sponsor: Bristol-Myers Squibb
Start date: 2006-08-01; Completion date: 2010-01-01
Enrollment: 52 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of dasatinib with that of high-dose (800-mg) imatinib in participants with chronic phase chronic myeloid leukemia who achieved only a suboptimal response after at least 3 months of monotherapy with 400-mg imatinib. The safety of these treatments will also be evaluated.

Detailed description:
Participants were randomized 2:1 to dasatinib or high-dose imatinib, respectively. Randomization was stratified by a suboptimal response, defined as a hematologic response less than a complete hematologic response after at least 3 months of monotherapy with 400-mg imatinib; a cytogenic response (CgR) less than a partial CgR (PCgR) after at least 6 months of monotherapy with 400-mg; a PCgR after at least 12 months of monotherapy with 400-mg imatinib; or less than a major molecular response with a complete CgR after at least 18 months of monotherapy with 400-mg imatinib.

Participants received either dasatinib or imatinib for 12 months or until disease progression, unacceptable toxicity, consent withdrawal, or study discontinuation. After 12 months, who had a confirmed major molecular response and were still receiving dasatinib, 100 mg, or imatinib, 800 mg, were eligible to extend treatment for an additional 12 months. Participants permanently discontinuing treatment before 12 months were considered treatment failures and withdrawn from the study.

Arms: arm 1: Participants with chronic phase chronic myeloid leukemia (CML) who had only a suboptimal response after at least 3 months of therapy with imatinib, 400 mg. arm 2: Participants with chronic phase CML who had only a suboptimal response after at least 3 months of therapy with imatinib, 400 mg.
Interventions: intervention 1: Imatinib intervention 2: Dasatinib
Intervention descriptions: intervention 1: Imatinib tablets administered orally at a dose of 400 mg twice daily. Each 400- mg dose to be taken with a meal and a large glass of water. intervention 2: Dasatinib tablets administered orally at a dose of 100 mg once daily.

Protocol documents:
Clinical trial NCT00331409
Conditions: Kidney Cancer
Keywords: stage III renal cell cancer stage IV renal cell cancer clear cell renal cell carcinoma recurrent renal cell cancer
Sponsor: OHSU Knight Cancer Institute
Start date: 2006-01-01; Completion date: 2010-01-01
Enrollment: 23 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Everolimus and imatinib mesylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Everolimus may also block blood flow to the tumor. Giving everolimus together with imatinib mesylate may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving everolimus together with imatinib mesylate works in treating patients with metastatic or unresectable kidney cancer.

Detailed description:
OBJECTIVES:

Primary

* Estimate the proportion of patients with previously treated metastatic or unresectable clear cell carcinoma of the kidney who are progression free (complete response \[CR\], partial response \[PR\], or stable disease \[SD\]) at 3 months after treatment with everolimus and imatinib mesylate.

Secondary

* Estimate median time to progression in patients treated with this regimen.
* Determine the proportion of patients whose best overall response are CR, PR, SD, or progressive disease.
* Evaluate the mean and range of the maximum percent reduction in tumor size.
* Describe the toxicities of this regimen in these patients.

OUTLINE: This is an open-label, multicenter study.

Patients receive oral imatinib mesylate and oral everolimus once daily beginning on day 1 and continuing in the absence of disease progression.

PROJECTED ACCRUAL: A total of 43 patients will be accrued for this study.

Arms: arm 1: Everolimus: 2.5 mg daily by mouth Imatinib Mesylate: 600 mg daily by mouth
Interventions: intervention 1: Everolimus intervention 2: imatinib mesylate
Intervention descriptions: intervention 1: 2.5 mg by mouth daily intervention 2: 600 mg by mouth daily

Protocol documents:
Clinical trial NCT00332605
Conditions: Methamphetamine Dependence
Keywords: Methamphetamine Dependence
Sponsor: University of Chicago
Start date: 2006-06-01; Completion date: 2010-01-01
Enrollment: 45 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of the proposed study is to evaluate the efficacy and safety of N-Acetyl Cysteine (NAC) in combination with naltrexone in methamphetamine dependence.

Detailed description:
Forty subjects with DSM-IV methamphetamine dependence will receive 8 weeks of double-blind combination medication (NAC plus naltrexone) or placebo. The hypothesis to be tested is that NAC plus naltrexone will be effective and well tolerated in patients with methamphetamine dependence compared to placebo. The proposed study will provide needed data on the treatment of a public health crisis that currently lacks a clearly effective treatment.

Arms: arm 1: Naltrexone tablets

N-Acetyl Cysteine: 600mg tablets, daily arm 2: Inactive placebo ("sugar pill")
Interventions: intervention 1: Naltrexone plus N-Acetyl Cysteine intervention 2: Placebo
Intervention descriptions: intervention 1: daily intervention 2: daily

Protocol documents:
Clinical trial NCT00345384
Conditions: Post-operative Pain Respiratory Depression
Keywords: Dexmedetomidine Sedation Opioid Respiratory depression
Sponsor: Baylor Research Institute
Start date: 2008-05-01; Completion date: 2010-01-01
Enrollment: 38 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the safety, efficacy, hemodynamic and respiratory stability of a low-dose of dexmedetomidine infusion in post-operative surgical in-patients undergoing thoracic surgery after discharge from PACU or ICU.

Detailed description:
Dexmedetomidine has sedative and analgesic properties that may reduce the opioid requirement in post-operative patients, thereby decreasing the chance of post-operative respiratory depression that occurs with opioid administration. In addition, patients may be more alert with less opioid medication. Currently, dexmedetomidine is not approved for use longer than twenty-four hours and must only be administered in the Intensive Care Unit where patients can be continuously monitored.

This is a prospective, double-blinded, control group pilot study. One group (the control group) will receive a normal saline infusion and the second group (the treatment group) will receive low-dose Dexmedetomidine for up to 24 hours after they are admitted to an open nursing unit (not an Intensive Care Unit).

During the surgery, the anesthesiologist will administer dexmedetomidine during the surgical procedure after an optional loading dose. All patients will receive pain medication using a Patient Controlled Analgesia (PCA) pump as per standard practice. In addition, if the physician deems necessary, an On-Q Pain Pump will deliver local anesthetic surrounding the incision under direction of the surgeon.

Before discharge from the PACU or ICU, each subject will receive either low-dose dexmedetomidine or normal saline using a continuous infusion pump for up to 24 hours after the subject is discharged from either the PACU or the ICU to an open nursing unit. While on the open nursing unit patient vital signs, oxygen saturation, Ramsay score and pain score will recorded every two hours until the treatment drug is stopped.

Arms: arm 1: One group (placebo comparator) will receive a normal saline infusion, set at a rate as if it were the active drug. arm 2: The second group (the study group) will receive a continuous infusion of dexmedetomidine titrated from 0.1 - 0.5 mics/kg/h to control pain for up to 24 hours after they are admitted to an open nursing unit after discharge from the PACU or ICU
Interventions: intervention 1: Dexmedetomidine intervention 2: Placebo (Normal Saline)
Intervention descriptions: intervention 1: Dexmedetomidine titrated over 24 hours intervention 2: None

Protocol documents:
Clinical trial NCT00358579
Conditions: Cardiac Arrest
Keywords: Vasopressin Adrenaline Survival Return of spontaneous of circulation
Sponsor: Singapore General Hospital
Start date: 2006-03-01; Completion date: 2010-01-01
Enrollment: 727 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field.

Thus the purpose of this study is to compare vasopressin and adrenaline in the treatment of cardiac arrest to answer the question whether there is an improvement in survival between vasopressin and adrenaline.

Detailed description:
The effectiveness of medications in cardiac arrest has been greatly debated and questioned. Historically intravenous adrenaline has been the recommended drug of choice since 1906. There have been few formal evaluations to determine the value of adrenaline for cardiac arrest, and clinical trials have not been able to show any benefit with intravenous adrenaline (compared to placebo or no treatment) in the field.

More recently, vasopressin has been used in patients with cardiac arrest. In human studies on vasopressin, clinical trials have produced conflicting results.

The current study compared vasopressin and adrenaline in the treatment of cardiac arrest in patients presenting to the Emergency Department (ED). Specific outcomes included return of spontaneous circulation (ROSC) (as measured by the presence of a palpable pulse at any time during resuscitation), survival to hospital admission, survival to discharge from hospital, and functional status at discharge and at one year (as measured by the Glasgow-Pittsburgh outcome categories).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Adrenaline intervention 2: Vasopressin
Intervention descriptions: intervention 1: 1 mg intervention 2: 40 IU

Protocol documents: