ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00395291
Conditions: Chronic Kidney Disease End Stage Renal Disease
Keywords: Chronic kidney disease End stage renal disease
Sponsor: University of Virginia
Start date: 2006-08-01; Completion date: 2010-05-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study is to determine MK-0677 increases IGF-1 in patients with end stage renal disease (ESRD) on hemodialysis.

Detailed description:
With development and progression of chronic kidney disease (CKD) to end stage renal disease (ESRD), malnutrition becomes an increasingly severe problem. This is thought to occur from two mechanisms: decreased appetite secondary to uremia and development of a catabolic inflammatory milieu. Patients experience decreased muscle mass and functional activity associated with increased morbidity and mortality. Many therapies to improve poor nutritional state have been used with little success. Growth hormone (GH) and insulin like growth hormone (IGF-1) improve muscle mass, quality of life, nutritional parameters, immune and physical functions but must be given parenterally and are limited by expense and patient compliance. Recently, the endogenous GH receptor secretagogue (GHRS) ghrelin has been shown to raise endogenous GH and improve food intake but must be given parenterally and is not available. The experimental drug MK-0677, a synthetic GHRS, ghrelin mimetic, which is given orally, has recently been shown to increase IGF-1 and muscle mass in the elderly. Its effects in CKD and ESRD are unknown. We will study the effects of MK-0677 on renal patients. Specifically, we hope to show that the drug increases IGF-1 in renal patients, and has similar effects to exogenous GH and IGF-1. Subjects will be ESRD hemodialysis patients. This protocol is an investigator-initiated, randomized, double-blind crossover, placebo-controlled pilot study. The study's primary outcome is IGF-1 levels for subjects. Secondary outcomes will be levels of cytokines, esterase, leptin, insulin, ghrelin, TNF-alpha, CRPs, IL-1, IL-6, IL-10, and adiponectin.

Arms: arm 1: MK-0677 and Placebo - All subjects were given MK-0677 for a 30 +/- 7 days and then they were given a placebo for 30 +/- 7 days. arm 2: MK-0677 and Placebo - All subjects were given Placebo for a 30 +/- 7 days and then they were given MK-0677 for 30 +/- 7 days.
Interventions: intervention 1: MK-0677 intervention 2: Placebo
Intervention descriptions: intervention 1: The dosage of the drug is 25mg, subjects will take one pill a day for about 30 days. intervention 2: Placebo

Protocol documents:
Clinical trial NCT00400764
Conditions: Non-Hodgkin's Lymphoma
Keywords: NHL Follicular NHL Rituxan Apo2L/TRAIL
Sponsor: Genentech, Inc.
Start date: 2006-06-01; Completion date: 2010-05-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This Phase Ib/II, open-label, multicenter trial is designed to evaluate the safety, pharmacokinetics, and efficacy of dulanermin when combined with rituximab in subjects with follicular, CD20+, B-cell Non-Hodgkin's Lymphoma (NHL) that has progressed following a response of ≥ 6 months duration to a prior rituximab-containing therapy. The multicenter, international, randomized Phase II part of this study will commence only after the safety and available pharmacokinetic data from the Phase Ib part of the study have been evaluated by the Sponsor and have been provided to participating investigators and the FDA.

Detailed description:

Arms: arm 1: Participants received 4.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses. arm 2: Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses. arm 3: Participants received rituximab administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses. arm 4: Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles. Participants also received rituximab administered by IV infusion at 375 mg/m\^2 weekly for up to eight doses. arm 5: Participants received 8.0 mg/kg/day dose of dulanermin, administered by intravenous (IV) infusion for 5 consecutive days at the start of each 21-day treatment cycle for up to four cycles.
Interventions: intervention 1: Dulanermin intervention 2: Rituximab
Intervention descriptions: intervention 1: Dulanermin was administered by intravenous (IV) infusion over 1 hour on days 1-5 of each 21-day cycle. intervention 2: Rituximab was administered by intravenous (IV) infusion at 375 mg/m\^2 weekly for up to eight doses.

Protocol documents:
Clinical trial NCT00400803
Conditions: Carcinoma, Non-Small-Cell Lung
Keywords: Carcinoma, Non-Small-Cell Lung Gemcitabine Carboplatin Bevacizumab Biological therapy Drug therapy
Sponsor: Masonic Cancer Center, University of Minnesota
Start date: 2007-03-01; Completion date: 2010-05-01
Enrollment: 38 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether treatment with carboplatin and gemcitabine combined with bevacizumab every two weeks will provide increased survival.

Detailed description:
Treatment with Carboplatin and gemcitabine is one of the most active combination therapies used for first-line therapy of NSCLC. The optimum schedule for administration of carboplatin and gemcitabine is currently unknown.

The addition of bevacizumab to another comparable platinum combination showed an overall survival advantage and a significantly greater response rate and progression-free survival.

Arms: arm 1: Patients treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.
Interventions: intervention 1: Gemcitabine, Carboplatin, Bevacizumab
Intervention descriptions: intervention 1: Patients will be treated with Gemcitabine 2000mg/m\^2 intravenously (IV) over 30 minutes, followed by Carboplatin AUC= 3 IV over 30 minutes and Bevacizumab 10 mg/kg IV over 90 minutes 1st infusion, 60 minutes 2nd infusion and 30 minutes for the following infusions. Cycles will be repeated every 2 weeks for a maximum of 6 cycles of therapy. Bevacizumab will continue to be given until disease progression.

Protocol documents:
Clinical trial NCT00409006
Conditions: Non-small Cell Lung Cancer
Sponsor: Eli Lilly and Company
Start date: 2007-02-01; Completion date: 2010-05-01
Enrollment: 70 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy and safety of chemotherapy followed sequentially by gefitinib versus chemotherapy alone in the first line treatment of non-small cell lung cancer (NSCLC). This study will be conducted in Asian patients who are classified as 'never smoker' since it is suggested that these patients are more likely to respond favorably to treatment with gefitinib.

Detailed description:

Arms: arm 1: Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by gefitinib 250 mg administered orally, once daily, until disease progression or unacceptable toxicity. arm 2: Pemetrexed 500 milligrams per meters squared (mg/m2) plus cisplatin 75 mg/m2 administered by intravenous (IV) infusion once every 3 weeks for 4 cycles without progression followed by pemetrexed 500 mg/m2 administered by IV infusion (with optional cisplatin 75 mg/m2 for up to 2 additional cycles) until disease progression or unacceptable toxicity.
Interventions: intervention 1: Pemetrexed intervention 2: Cisplatin intervention 3: Gefitinib
Intervention descriptions: intervention 1: 500 milligrams per meter squared (mg/m2), administered by intravenous (IV) infusion every 21 days for 4 cycles (1-4) or 500 mg/m2, IV, every 21 days until disease progression or unacceptable toxicity. intervention 2: 75 mg/m2, IV, every 21 days for 4 cycles (1-4) or 75 mg/m2, IV, every 21 days for 4 cycles with optional continuation for 2 additional cycles until disease progression or unacceptable toxicity intervention 3: 250 mg, administered orally once daily beginning at Cycle 5 until disease progression or unacceptable toxicity

Protocol documents:
Clinical trial NCT00411788
Conditions: Breast Cancer
Keywords: HER-2 positive breast cancer HER-2 positive breast cancer
Sponsor: Yale University
Start date: 2006-12-01; Completion date: 2010-05-01
Enrollment: 11 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Rapamune (generic name: Sirolimus®) is a drug that has been approved by the Food and Drug Administration (government) for use in patients receiving a kidney transplant to prevent the patient's body from rejecting the transplanted kidney. It has shown antitumor effects in the laboratory, but has not been approved at this time for the treatment of cancer. Herceptin is a new form of chemotherapy that has been approved by the Food and Drug Administration for the treatment of breast cancer.

This study is designed to evaluate the effect and safety of combining Rapamune and Herceptin on breast cancer. Rapamune and Herceptin are being combined because results from our laboratory studies suggest that the combination of the two drugs is superior to either drug used alone. Results from laboratory studies performed at other institutions suggest that adding Rapamune to Herceptin may also reverse the resistance to Herceptin. Although there has been extensive experience using Herceptin alone and Rapamune alone in human subjects, the combination of Herceptin and Rapamune has not been previously evaluated. In addition, we hope to better understand how these treatments work against an individual woman's tumor by analyzing tissue samples before, and during treatment.

Detailed description:

Arms: arm 1: Patients received oral sirolimus 6 mg daily in combination with weekly trastuzumab administered intravenously with a loading dose of 4 mg/kg followed by 2 mg/kg weekly in a 28-day cycle. A subsequent amendment allowed trastuzumab to be administered every 3 weeks for patient convenience, with a loading dose of 8 mg/kg followed by a 6 mg/kg in a 21-day cycle. Sirolimus was administered at a 6 mg oral daily dose. Cycles were repeated on an every 21 or 28-day schedule until disease progression, unacceptable toxicity, or the development of any of the criteria for study removal. Doses were reduced or discontinued based on tolerability.
Interventions: intervention 1: Rapamycin intervention 2: Trastuzumab
Intervention descriptions: intervention 1: oral rapamycin 6 mg daily intervention 2: Trastuzumab 4 mg/kg will be administered (intravenous) on day 1, and this will be followed by weekly dose of 2 mg/kg starting day 8.

Protocol documents:
Clinical trial NCT00416715
Conditions: Arthralgia Musculoskeletal Complications Pain Recurrent Breast Cancer Stage I Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer Stage IIIB Breast Cancer Stage IIIC Breast Cancer
Sponsor: University of Washington
Start date: 2006-10-01; Completion date: 2010-05-01
Enrollment: 100 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial is studying vitamin D deficiency, muscle pain, joint pain, and joint stiffness in postmenopausal women receiving letrozole for stage I-III breast cancer. Learning about vitamin D deficiency and muscle pain, joint pain, and joint stiffness in patients receiving letrozole for breast cancer may help doctors plan treatment and may help patients live more comfortably

Detailed description:
PRIMARY OBJECTIVES:

I. To assess the rate of vitamin D deficiency in breast cancer patients who experience myalgias, arthralgias and/or joint stiffness following initiation of adjuvant letrozole treatment.

SECONDARY OBJECTIVES:

I. To determine if there is a correlation between letrozole serum levels and the development of myalgias, arthralgias and/or joint stiffness.

II. To assess if vitamin D supplementation may alleviate myalgias, arthralgias and/or joint stiffness associated with letrozole in those subjects with vitamin D deficiency.

OUTLINE:

Patients receive letrozole orally (PO) once daily (QD). Patients, who experience muscle pain, joint pain, or joint stiffness that requires an intervention and who are found to be vitamin D deficient, also receive calcium PO and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.

Arms: arm 1: Patients receive letrozole PO QD. Patients, who experience muscle pain, joint pain, or joint stiffness that requires an intervention and who are found to be vitamin D deficient, also receive calcium and vitamin D3 PO. Treatment continues for up to 28 weeks in the absence of disease progression or unacceptable toxicity.
Interventions: intervention 1: letrozole intervention 2: calcium carbonate intervention 3: laboratory biomarker analysis intervention 4: calcium citrate intervention 5: calcium glucarate intervention 6: calcium gluconate intervention 7: cholecalciferol intervention 8: assessment of therapy complications intervention 9: musculoskeletal complications management/prevention
Intervention descriptions: intervention 1: Given PO intervention 2: Given PO intervention 3: Optional correlative studies intervention 4: Given PO intervention 5: Given PO intervention 6: Given PO intervention 7: Given PO intervention 8: Ancillary studies intervention 9: Correlative studies

Protocol documents:
Clinical trial NCT00420290
Conditions: End Stage Renal Disease
Keywords: inflammation end stage renal disease
Sponsor: Vanderbilt University
Start date: 2008-01-01; Completion date: 2010-05-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Chronic hemodialysis (CHD) patients display multiple metabolic abnormalities related to advanced uremia. Despite vigorous attempts to prevent these abnormalities and their consequences, most CHD patients suffer from a unique form of nutritional derangement, which can be termed as "uremic wasting". Several studies have demonstrated that the presence of uremic wasting, especially the degree of loss of muscle mass, sharply increases mortality and hospitalization rate in CHD patients.

Several factors have been thought to be associated with uremic wasting, including hormonal derangement, anorexia, physical inactivity, and concurrent illnesses. Chronic inflammation, also highly prevalent in these patients, causes muscle catabolism in animal models and certain clinical conditions. Epidemiological studies show an association between chronic inflammation and uremic wasting in hemodialysis patients indicating a possible causal relationship.

The cause for the activated inflammatory state in CHD patients is believed to be multi-factorial. Nevertheless, it is certainly important for the host to limit its biological activity by eliciting a stronger anti-inflammatory response, for example through the production of naturally occurring receptor antagonist. Interleukin 1 beta, one of the major pro-inflammatory cytokines has been shown to be associated with protein catabolism in several chronic disease states, including advanced uremia. A balance between interleukin 1 beta (agonist) and its naturally occurring receptor antagonist IL-1ra may play a pivotal role in controlling the inflammatory response and its consequences in this population.

The overall goal of this particular grant application is to examine the short-term effects of the administration of the recombinant form of IL-1ra on 1) chronic inflammatory state and 2) protein homeostasis in chronically inflamed CHD patients.

We have updated our protocol to perform an interim analysis. The interim analysis will be performed after half of the planned study sample has been enrolled (14 subjects; 7 in each arm). The interim analysis has been approved by the Data Safety Monitoring Board.

Detailed description:

Arms: arm 1: Interleukin-1 receptor antagonist arm 2: None
Interventions: intervention 1: kineret intervention 2: placebo
Intervention descriptions: intervention 1: 100 mg administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks intervention 2: 100 mg administered subcutaneously every other day (3 days a week during hemodialysis) for 4 weeks

Protocol documents:
Clinical trial NCT00421603
Conditions: Cocaine Dependence
Keywords: Cocaine Adderall Topiramate ADHD
Sponsor: New York State Psychiatric Institute
Start date: 2007-02-01; Completion date: 2010-05-01
Enrollment: 81 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The proposed protocol is a double-blind, placebo-controlled outpatient study of the safety and efficacy of Adderall-XR (ER-MAS) and topiramate in the treatment of cocaine dependence. Since both of these medications have independently shown promise in helping with cocaine abuse we are proposing that together they may be even more successful in the treatment of cocaine abuse. We plan to enroll 120 subjects in a 14-week trial. The primary objective of the study is to determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients. This study includes free treatment for cocaine dependence that includes medication.

Detailed description:
Specific Aim 1: To determine the efficacy of ER-MAS and topiramate in promoting cocaine abstinence among cocaine-dependent patients.

Primary Hypothesis: The proportion of participants achieving sustained cocaine abstinence (via urine toxicology) for three consecutive weeks during the study will be significantly greater for the combined pharmacotherapies group compared to the placebo group.

Hypothesis 2: The proportion of urine samples negative for cocaine metabolites will be greater in the combined pharmacotherapies group compared to the placebo group.

Hypothesis 3: The pattern of cocaine use (amount of cocaine used per day in dollars and the number of using days per week), as measured by the time-line follow-back method, will show a greater reduction in use for the combined pharmacotherapies group compared to the placebo group.

Specific Aim 2: To determine the effect of ER-MAS and topiramate on cocaine craving among cocaine-dependent patients.

Hypothesis 4: Cocaine craving symptoms will be reduced to a greater degree in the combined pharmacotherapies group compared to the placebo group.

Specific Aim 3: To explore a set of related secondary outcomes (treatment retention, global functioning, HIV risk behavior) as well as moderators and mediators potentially reflective of mechanism of action.

Arms: arm 1: Adderall-XR (60 mg/day) and Topiramate (300mg/day) arm 2: Placebo
Interventions: intervention 1: Adderall-XR and Topiramate intervention 2: Placebo
Intervention descriptions: intervention 1: Adderall-XR 60mg/day and Topiramate 300mg/day intervention 2: Placebo

Protocol documents:
Clinical trial NCT00427648
Conditions: Overactive Bladder
Keywords: Administration, Intravesical Anesthetics, Local
Sponsor: Frank Tu
Start date: 2006-03-01; Completion date: 2010-05-01
Enrollment: 22 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether alkalized lidocaine instilled into the bladder is effective in the treatment of overactive bladder (OAB).

Detailed description:
Existing first-line treatments for overactive bladder are limited by requirements for chronic dosing and associated systemic side effects. Small case series suggest that bladder instillation of lidocaine may be effective in downregulating the afferent neuronal activity of a sensitized bladder, leading to elevation of the urge sensory threshold and decreasing detrusor activity. However, neither the effectiveness over placebo nor the durability of the response has been previously investigated.

Comparison(s): We propose a randomized, prospective double-blinded controlled trial to determine if a three-week trial of intravesical alkalized lidocaine instillation decreases symptoms of overactive bladder more than instillation of normal saline using a validated outcome instrument, the OAB-q.

Arms: arm 1: xylocaine arm 2: normal saline
Interventions: intervention 1: alkalinized xylocaine intervention 2: placebo
Intervention descriptions: intervention 1: 30 cc of 1% xylocaine and 10 cc of 0.9% sodium bicarbonate, dosed twice a week for three weeks intervention 2: normal saline

Protocol documents:
Clinical trial NCT00436163
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2007-03-01; Completion date: 2010-05-01
Enrollment: 39 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm study will evaluate the efficacy and safety of peginterferon alfa-2a in treatment-naive Baltic participants with Hepatitis B envelope antigen (HBeAg)-positive chronic Hepatitis B virus (HBV). All participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneously once weekly. Following 48 weeks of treatment, there will be a 24 week period of treatment-free follow-up. The anticipated time on study treatment is 3-12 months, and the target sample size is less than 100 participants.

Detailed description:

Arms: arm 1: Participants received peginterferon alfa-2a (Pegasys) 180 mcg subcutaneously once per week for 48 weeks.
Interventions: intervention 1: Peginterferon alfa-2a
Intervention descriptions: intervention 1: 180 mcg subcutaneously once per week for 48 weeks.

Protocol documents: