ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00997113
Conditions: Sedation
Keywords: propofol alfentanil procedural sedation stress biomarkers Deep procedural sedation in the ED
Sponsor: Hennepin Healthcare Research Institute
Start date: 2009-10-01; Completion date: 2012-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized clinical trial of deep procedural sedation with propofol with and without supplemental alfentanil. Patients will be assessed for total and fractionated serum catecholamines before and after the procedure in addition to usual procedural sedation outcomes parameters to assess the adrenergic effect of propofol sedation without supplemental opioid.

Detailed description:

Arms: arm 1: propofol only for deep procedural sedation arm 2: Propofol with alfentanil for deep procedural sedation
Interventions: intervention 1: propofol intervention 2: alfentanil
Intervention descriptions: intervention 1: 1 mg/kg IV followed by 0.5 mg/kg iv prn sedation intervention 2: alfentanil 10 ug/kg immediately prior to propofol dose

Protocol documents:
Clinical trial NCT01002105
Conditions: Alcohol Dependence
Keywords: Baclofen Alcohol Baclofen as add-on to standard treatment of alcohol
Sponsor: Sha'ar Menashe Mental Health Center
Start date: 2010-01-01; Completion date: 2012-12-01
Enrollment: 75 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is a study of Baclofen as an add-on to standard treatment for alcohol-dependent patients.

Detailed description:
Double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. The percentages of heavy drinking days and abstinent days were the primary outcome measures, and craving; distress and depression levels; self-efficacy; social support from family, friends and significant others; and health-related quality of life (HRQL) were secondary outcomes. Tolerability was also examined.

Arms: arm 1: The study was a double-blind, placebo-controlled, randomized trial comparing 50 mg/day of baclofen to placebo over 12 weeks, in addition to a low-intensity psychosocial intervention program, with 26-week and 52-week follow-up observations. arm 2: Intervention of the addition of placebo to low-intensity psychosocial intervention program. This was the control group
Interventions: intervention 1: Baclofen intervention 2: Control group
Intervention descriptions: intervention 1: Baclofen 50mg per day for 12 weeks and psychosocial intervention intervention 2: psychosocial intervention and placebo for 12 weeks

Protocol documents:
Clinical trial NCT01002872
Conditions: Metabolic Bone Disease
Keywords: FGF23 CKD Fosrenol Hyperphosphatemia
Sponsor: Endeavor Health
Start date: 2009-10-01; Completion date: 2012-12-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of the study is to assess the effects of the drug lanthanum carbonate (a phosphorus binder drug) on c-terminal and on FGF23 levels in patients with Chronic Kidney Disease (CKD).

Targeting FGF23 measurement in CKD patients may impact both the progression of kidney disease and patient mortality.

Detailed description:
This is a double blind randomized placebo controlled pilot study. Subjects with Chronic Kidney Disease ( CKD) stages 3-5 who are not undergoing renal replacement therapy and have not been started on phosphate binders will be randomized to either lanthanum carbonate 1500 mg daily or placebo for a 60 day treatment period. Patient doses will be increased up to a maximum dose of 3000 mg if the serum phosphate is greater than 5.5 mg/dL.

Arms: arm 1: Subjects will receive the study drug Lanthanum Carbonate ( Fosrenol) arm 2: Subject will receive placebo
Interventions: intervention 1: Lanthanum Carbonate (Fosrenol) intervention 2: placebo
Intervention descriptions: intervention 1: Randomization To either Lanthanum Carbonate 1 pill TID/Placebo 1 pill three times a day (TID) Day 15 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID. If phosphorus \<3.5mg/dL Reduce to 1 pill twice a day (BID). If Phosphorus \>5.5mg/dL 1 pill with breakfast 1 pill with lunch 2 pills with dinner Day 30 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus is \<3.5mg/dL Reduce to 1 pill daily. If phosphorus \>5.5mg/dL 1 pill with breakfast 2 pills with lunch 2 pills with dinner Day 45 If phosphorus is 3.5mg/dL-5.5mg/dL Continue with 1 pill TID If phosphorus \<3.5mg/dL stop the drug If phosphorus is \>5.5mg/dL 2 pills with breakfast 2 pills with lunch 2 pills with dinner intervention 2: Initial dose of placebo will be 1 pill three times a day

Protocol documents:
Clinical trial NCT01003938
Conditions: Ovarian Cancer
Keywords: chemotherapy combination therapy targeted therapy second-line
Sponsor: NYU Langone Health
Start date: 2009-08-01; Completion date: 2012-12-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single arm phase II study with a combination of Hycamptin® (topotecan) and erlotinib for a minimum of 2 cycles in patients (18 yrs of age and older) with recurrent ovarian cancer previously treated with chemotherapy drug Hycamptin® (topotecan). Up to 30 patients will be enrolled in this study.

Detailed description:
On Day 1 of each treatment cycle, topotecan 0.4 mg/m\^2/day will be administered via continuous infusion for 9 days beginning on Day 1 of every 21 day cycle. Additionally, patients will receive erlotinib 150 mg daily Days 1-9 in a cycle of 21 days. Thereafter both drugs will be given as long as patient benefit continues. Treatment will be administered on an inpatient or outpatient basis, repeating administration on an every 3 week cycle.

A cycle will be one three-week course of the erlotinib-topotecan regimen (the cycle could be extended to 4 weeks if blood studies at 21 days result in treatment delay).

The dose of topotecan will be calculated as follows:

BSA (m\^2) X drug dose (mg/m\^2) = dose (mg)

Arms: arm 1: Topotecan 0.4 mg/m\^2/day administered via continuous infusion for 9 days beginning on Day 1, every 21 days cycle; erlotinib 150 mg daily for 9 days every 21 days cycle. Both drugs will be given for a minimum of 2 cycles.
Interventions: intervention 1: Topotecan intervention 2: Erlotinib
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01009203
Conditions: Squamous Cell Carcinoma
Keywords: squamous cell carcinoma head neck aerodigestive
Sponsor: New Mexico Cancer Research Alliance
Start date: 2009-12-01; Completion date: 2012-12-01
Enrollment: 13 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary hypothesis of this study is that the addition of mammalian target of rapamycin (mTOR) blockade to conventional epidermal growth factor receptor (EGFR) blockade will result in synergistic clinical activity in Squamous Cell Carcinoma of the Head and Neck (SCCHN), consistent with preclinical xenograft data. Patients will be treated with the combination of temsirolimus and erlotinib, at the previously established Maximal Tolerated Dose (MTD). The primary signal of efficacy will be progression free survival (PFS), anticipating that PFS will be prolonged compared to historical PFS in SCCHN patients treated with erlotinib or cetuximab monotherapy.

Detailed description:
This is a phase II, multicenter, single arm, open-label study. Thirty-seven patients with advanced, platinum-refractory or platinum-ineligible squamous cell carcinoma of the head and neck will be sequentially enrolled to a single treatment arm. Patients will be treated with continuous, 28-day cycles of 150 mg of erlotinib by mouth daily and 15 mg of temsirolimus intervenously weekly. In the absence of grade 3 or higher toxicity in the first cycle, a single, intra-patient dose increase to 20 mg temsirolimus will be permitted.

Arms: arm 1: Erlotinib (Tarceva) at 150 mg by mouth daily + Temsirolimus (Torisel) at 15 mg intravenously weekly. Each cycle is comprised of 28 days
Interventions: intervention 1: Erlotinib intervention 2: Temsirolimus
Intervention descriptions: intervention 1: Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent. intervention 2: In the absence of Grade 3 or higher toxicity, a single, intra-patient dose increase of temsirolims to 20 mg intravenously weekly is permitted after the first 28 day cycle. Treatment will continue until disease progression, unacceptable toxicity, or withdrawal of informed consent.

Protocol documents:
Clinical trial NCT01015560
Conditions: Metastatic Cancer Unspecified Adult Solid Tumor, Protocol Specific
Keywords: bone metastases unspecified adult solid tumor, protocol specific
Sponsor: SWOG Cancer Research Network
Start date: 2010-03-01; Completion date: 2012-12-01
Enrollment: 44 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Monoclonal antibodies, such MLN1202, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them.

PURPOSE: This phase II trial is studying how well MLN1202 works in treating patients with bone metastases.

Detailed description:
OBJECTIVES:

Primary

* To assess the urinary n-telopeptide (uNTX) response to anti-CCR2 monoclonal antibody MLN1202 in patients with bone metastases.

Secondary

* To assess the feasibility of performing cross-disease site trials within the Southwest Oncology Group.
* To explore the effect of anti-CCR2 monoclonal antibody MLN1202 on markers of tumor cell proliferation, monocytes/macrophage trafficking, and osteoclast maturation.
* To estimate allele frequencies of defined SNPs occurring in the CCL2 and CCR2 genes in these patients.

OUTLINE: This is a multicenter study.

Patients receive anti-CCR2 monoclonal antibody MLN1202 IV over 1 hour on days 1, 15, and 29 in the absence of disease progression or unacceptable toxicity.

Patients undergo urine and blood sample collection at baseline and on days 15, 29, and 43 for correlative biomarker and polymorphism studies.

After completion of study treatment, patients are followed up for ≥ 30 days.

Arms: arm 1: MLN1202 8mg/kg IV Days 1, 15, 29 given as 1 6 week cycle
Interventions: intervention 1: anti-CCR2 monoclonal antibody MLN1202 intervention 2: polymorphism analysis intervention 3: laboratory biomarker analysis
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents:
Clinical trial NCT01024335
Conditions: Opioid Dependence
Keywords: opioid dependence naltrexone vivitrol dronabinol marinol
Sponsor: New York State Psychiatric Institute
Start date: 2010-01-01; Completion date: 2012-12-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We hypothesize that administering dronabinol during detoxification and during the first few weeks of naltrexone treatment will lead to improved naltrexone tolerability, resulting in better naltrexone compliance and treatment retention, and ultimately a reduction in opioid use and relapse rates.

Detailed description:
The goal of this two-year study is to test the efficacy of dronabinol as an adjunct to maintenance treatment with naltrexone in opioid-dependent individuals. We are proposing a randomized, double-blind, placebo controlled, parallel-groups, 8 week study of relapse prevention in opioid-dependent individuals. Participants will be randomized into one of two conditions (1) Naltrexone and Placebo (N=20) and (2) Naltrexone and dronabinol 15 mg bid (N=40). Treatment will be delivered in an outpatient setting except for the initial phase of inpatient detoxification, lasting 8 days. A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections), while dronabinol or placebo will be taken daily. In addition, patients will receive a psychosocial intervention that will include elements of motivational interviewing and cognitive-behavioral relapse prevention therapy. The primary aim is to test the efficacy of dronabinol in improving tolerability of naltrexone induction and reducing attrition during detoxification and the first two months of naltrexone treatment. The primary outcome will be the severity of opiate withdrawal and craving. The secondary outcome will be will be retention in treatment at study's end.

Arms: arm 1: A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month while placebo will be taken daily for the first 5 weeks of treatment. arm 2: A long-acting, injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month (the total of two injections, once at the end of hospitalization, and once at end of first month of outpatient treatment), while dronabinol (15 mg bid) will be taken daily for the first 5 weeks of treatment.
Interventions: intervention 1: injectable naltrexone and dronabinol intervention 2: Naltrexone and placebo
Intervention descriptions: intervention 1: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus dronabinol 15 mg bid for the first 5 weeks of treatment. intervention 2: Injectable form of naltrexone 380 mg (Vivitrol) will be administered once per month plus placebo bid for 5 weeks.

Protocol documents:
Clinical trial NCT01031680
Conditions: Type 2 Diabetes Mellitus Cardiovascular Disease Hypertension Inadequate Glycaemic Control
Keywords: dapagliflozin diabetes cardiovascular disease hypertension
Sponsor: AstraZeneca
Start date: 2010-02-01; Completion date: 2012-12-01
Enrollment: 922 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is carried out to assess whether dapagliflozin lowers blood glucose, body weight and blood pressure, when added to patients existing medications and how it compares with their usual treatment without added dapagliflozin. Safety data will be collected and analysed to confirm that treatment with dapagliflozin is safe and well tolerated in patients who have diabetes, cardiovascular disease and hypertension.

Detailed description:

Arms: arm 1: Dapagliflozin 10 mg tablet arm 2: Matching placebo tablet
Interventions: intervention 1: Dapagliflozin intervention 2: Placebo
Intervention descriptions: intervention 1: 10 mg tablet, oral, once daily, 24- week treatment and 80-week extension period intervention 2: Matching placebo tablet, oral, once daily, 24- week treatment and 80-week extension period

Protocol documents:
Clinical trial NCT01033734
Conditions: Influenza
Sponsor: Hoffmann-La Roche
Start date: 2010-12-01; Completion date: 2012-12-01
Enrollment: 8 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study will assess the pharmacokinetics/pharmacodynamics and safety of intravenous (iv) Tamiflu (oseltamivir) in 3 cohorts of children, aged 6-12, 3-5 and 1-2 years, with influenza infection. Patients will receive iv Tamiflu therapy for 5 days (10 doses). For patients whose conditions no longer merit continued iv dosing, therapy may be switched to oral Tamiflu to complete their prescribed course of treatment. If medically necessary, iv or oral therapy with Tamiflu may be continued for up to 5 additional days. Anticipated time on study treatment is 5 to 10 days.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: oseltamivir [Tamiflu]
Intervention descriptions: intervention 1: 5-day course (10 doses), intravenous administration, may be switched to oral administration at the discretion of the investigator; up to 5 additional days of treatment possible.

Protocol documents:
Clinical trial NCT01034592
Conditions: Anemia Leukemia Acute Myeloid Leukemia (AML) Myelodysplastic Syndromes (MDS)
Sponsor: Jason Robert Gotlib
Start date: 2009-11-01; Completion date: 2012-12-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single-center, single arm, open-label study of oral lenalidomide monotherapy administered to red blood cell (RBC) transfusion dependent adult subjects with Diamond-Blackfan Anemia (DBA).

Primary Objective: To evaluate the erythroid response rate as measured by rate of red blood cell transfusion independence \[MDS International Working Group (IWG) 2000 Criteria will be applied\].

Secondary Objective: 1)To evaluate the tolerability and safety profile of lenalidomide in patients with DBA and other inherited marrow failure syndromes 2) To correlate response to lenalidomide with biologic surrogates of DBA including ribosomal protein mutation status, ex vivo erythroid colony growth, and microarray gene expression

Detailed description:
This pilot study will utilize an intra-patient dose escalation design. Cycles are 28 days in length. Subjects will receive lenalidomide 2.5 mg weekly during days 1 to 21 of cycle 1 (dose level 1). If patients do not experience any grade \> 3 hematologic or non-hematologic toxicity, the dose will be increased to 2.5 mg twice weekly on days 1 to 21 of cycle 2 (dose level 2). If patients do not experience any grade \> 3 hematologic or non-hematologic toxicity, the dose will be increased to 5 mg twice weekly on days 1 to 21 of cycle 3 (dose level 3). If patients do not experience any grade \>3 hematologic or non-hematologic toxicity, the dose will be increased to 5 mg thrice weekly on days 1 to 21 of cycle 4 (dose level 4). Patients who experience grade \>3 hematologic or non-hematologic toxicity at dose level 1 will be discontinued from study. Patients who experience grade \> 3 hematologic or non-hematologic toxicity at dose level 2, 3, or 4 will have the lenalidomide held and dose reduced according to protocol dose interruption/modification algorithms (section 5.5.3). If at least a minor erythroid response is not achieved at the end of 8 cycles of treatment, patients will be discontinued from study. If a minor or major erythroid response is achieved after completion of 8 cycles of treatment, patients can continue study drug on a maintenance phase until loss of erythroid response (return to baseline hemoglobin or transfusion requirement) or unacceptable toxicity.

Arms: arm 1: Subjects will initially receive lenalidomide 2.5 mg, and may escalate up to 2.5 mg/wk up to 5 mg 3x/wk, depending toxicity and response.
Interventions: intervention 1: Lenalidomide
Intervention descriptions: intervention 1: 2.5 mg/wk up to 5 mg 3x/wk

Protocol documents:
Clinical trial NCT01052701
Conditions: Hepatitis C HIV
Sponsor: Johns Hopkins University
Start date: 2009-12-01; Completion date: 2012-12-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to find out whether abacavir (Ziagen®) lowers the levels of ribavirin (Ribapak®) in the body of persons taking these two drugs.

Detailed description:
Abacavir is an anti-HIV drug that belongs to the class of nucleoside reverse transcriptase inhibitors. Ribavirin is a drug used to treat hepatitis C infection. Both abacavir and ribavirin are approved by the Food and Drug administration (FDA). The doses of abacavir and ribavirin used in this study are also FDA approved.Some individuals who have HIV infection also have hepatitis C. It is possible that they may need to take both abacavir to treat HIV and ribavirin to treat hepatitis C. Recent studies suggest that abacavir decreases the level of ribavirin in the body, in the blood and in cells named peripheral blood mononuclear cells (PBMC's). Thus, taking ribavirin and abacavir together could lead to treatment failure for hepatitis C. Therefore, it is important to understand whether ribavirin levels are affected when the two medications are taken together.

Arms: arm 1: Ribavirin plus Abacavir Administration intervention arm 2: Ribavirin alone administration
Interventions: intervention 1: Ribavirin intervention 2: Ribavirin plus Abacavir (ABC)
Intervention descriptions: intervention 1: Daily Ribavirin alone 400 mg in the morning (AM) and 600 mg in the afternoon (PM) orally with 12 hours between the doses (Body Weight ≤75 kg)

OR

Daily RBV alone 600 mg orally every 12 hours (Body Weight \>75 kg) intervention 2: Daily Ribavirin 400 mg in AM and 600 mg in PM orally with 12 hours between the doses (Body Weight ≤75 kg)

OR

Daily RBV 600 mg orally every 12 hours (Body Weight \>75 kg)

Plus

Daily Abacavir 300 mg orally every 12 hours

Protocol documents:
Clinical trial NCT01052831
Conditions: Impulse Control Disorder Parkinson Disease
Keywords: Compulsive Gambling Compulsive Buying Compulsive Shopping Compulsive Eating Hypersexuality Dopamine Agonists Mirapex Pramipexole Requip Ropinirole Impulse Control Disorders
Sponsor: University of Pennsylvania
Start date: 2009-11-01; Completion date: 2012-12-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the effectiveness of naltrexone in reducing ICD symptoms in Parkinson's disease patients taking a dopamine agonist.

Detailed description:
Impulse control disorders (ICDs), including compulsive gambling, sexual behavior, buying, and eating, are increasingly recognized as a significant clinical problem in Parkinson's disease (PD), occurring in up to 15% of patients. Dopamine agonist (DA) treatment is thought to be the primary risk factor for the development of ICDs in PD. ICDs often lead to significant impairments in psychosocial functioning, interpersonal relationships, and quality of life. The management of ICDs in the context of PD can be complex. Patients may be reluctant to discontinue DA treatment due to the motor benefits derived from treatment, so patients often have chronic symptoms. Thus, additional treatment approaches are needed.

A medication shown to be efficacious for the treatment of ICDs with minimal impact on parkinsonism would allow many ICD patients to continue on full-dose DA treatment. Naltrexone, a long-acting opioid receptor antagonist, helps in the treatment of alcohol and opioid dependence. In addition, placebo-controlled studies have demonstrated that it helps in the treatment of pathological gambling in the general population. Opioids regulate dopamine pathways in areas of the brain linked with impulse control disorders, and opioid antagonists block opioid receptors in these regions. In this study, 48 PD patients with an ICD will be treated either with naltrexone (50-100 mg/day) or placebo for a period of 8 weeks. The study will assess if naltrexone improves ICD symptoms in PD and is well tolerated. To our knowledge, the proposed study is the first controlled trial of an agent to treat ICDs in PD.

Arms: arm 1: For the first four weeks of the study, participants were administered naltrexone at 50mg per day. Participants not in response at week 4 were increased to 100mg per day for the remaining four weeks of the study. arm 2: Participants received the placebo treatment which looked identical to active study medication.
Interventions: intervention 1: Naltrexone intervention 2: Placebo
Intervention descriptions: intervention 1: 50-100 mg qd for 8 weeks intervention 2: 50-100 mg qd for 8 weeks

Protocol documents: