ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00905489
Conditions: HIV Infections
Sponsor: Boehringer Ingelheim
Start date: 2009-06-01; Completion date: 2012-09-01
Enrollment: 85 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective is to establish the pharmacokinetic (PK) profile at steady state of nevirapine XR in HIV infected children from \>=3 to \<18 years of age. This phase I trial is an open-label, multiple dose, non-randomized and cross-over study. Patients who have completed the last visit of the PK trial (visit 7) can enter into an Optional Extension Phase (OEP) until the Investigational New Drug (IND) is withdrawn; until nevirapine XR becomes approved and is available by prescription in a given country; or, the patient enrolls in a compassionate use program. During this OEP, nevirapine XR safety and efficacy information will be collected.

Detailed description:

Arms: arm 1: In this pharmaco-kinetic (PK) cross-over design trial, all patients initially receive nevirapine immediate release and then all patients are switched to nevirapine extended release 200 mg, 300 mg or 400 mg QD. After completing the PK phase patients had the option of continuing treatment with nevirapine XR in the Optional Extension Phase (OEP).
Interventions: intervention 1: Nevirapine Immediate Release (IR) intervention 2: Nevirapine Extended Release (XR)
Intervention descriptions: intervention 1: 200 mg Tablet or 50 mg / 5 ml oral suspension intervention 2: 200 mg, 300 mg or 400 mg Tablet formulation

Protocol documents:
Clinical trial NCT00916617
Conditions: Alzheimer Disease
Keywords: open-label safety antibody
Sponsor: Pfizer
Start date: 2009-06-01; Completion date: 2012-09-01
Enrollment: 62 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and tolerability of bapineuzumab when administered by subcutaneous injection. The study is open only to subjects who participated in the preceding double-blind study (3133L1-2203 US). Subjects will receive weekly injections of bapineuzumab for 3 years (156 doses). One dosage level will be included: 5 mg/week. All subjects will receive active treatment (bapineuzumab) and no subjects will receive placebo.

Detailed description:

Arms: arm 1: 5 mg/week
Interventions: intervention 1: bapineuzumab
Intervention descriptions: intervention 1: 5 mg/week subcutaneous bapineuzumab

Protocol documents:
Clinical trial NCT00936741
Conditions: Cushing's Syndrome
Keywords: Cushing's Disease Cushing's Syndrome Cushings Pituitary ACTH Adrenocorticotropic hormone Ectopic Adrenal adenoma Adrenal carcinoma Adrenal autonomy Cortisol Hypercortisolemia Cushingoid Moon facies Dorsocervical fat Plethora Hirsutism Violaceous striae Hormone Contraceptive Endocrine Cushing Syndrome Ectopic ACTH Secretion
Sponsor: Corcept Therapeutics
Start date: 2009-07-01; Completion date: 2012-09-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Participants in study C-1073-400 (NCT00569582) will be invited to participate in this extension study to examine the long term safety of mifepristone in the treatment of the signs and symptoms of endogenous Cushing's syndrome. Total treatment duration may be up to 12 months or longer at the discretion of the Investigator.

Detailed description:
Up to 50 subjects will receive mifepristone daily. Subjects completing 24 weeks of mifepristone treatment under Corcept protocol C1073-400 (NCT00569582) will be eligible to continue treatment for an additional 1 year. Assessments of safety, as evaluated by physical examinations, vital signs, laboratory tests and adverse events, will be made. Persistence of improvement in response to mifepristone treatment will also be evaluated during this extension study by assessing the continued or sustained improvement in the signs and symptoms of Cushing's syndrome.

Arms: arm 1: Mifepristone 300mg to 1200mg once daily
Interventions: intervention 1: mifepristone
Intervention descriptions: intervention 1: Mifepristone 300 mg to 1200 mg once daily

Protocol documents:
Clinical trial NCT00949325
Conditions: Sarcoma
Keywords: osteosarcoma soft tissue sarcoma rhabdomyosarcoma leiomyosarcoma Ewing's sarcoma chondrosarcoma liposarcoma malignant fibrous histiocytoma malignant peripheral nerve sheath tumor pleiomorphic sarcoma spindle cell sarcoma synovial sarcoma cancer stem cell
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Start date: 2009-09-01; Completion date: 2012-09-01
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to identify a safe dosing regimen for the combination of Torisel and liposomal doxorubicin in patients with recurrent sarcoma. A secondary purpose of the study is to determine how effective this combination is for the treatment of recurrent sarcoma.

Detailed description:
The effectiveness of treatments for recurrent sarcomas is quite limited. One hypothesis to explain the refractory nature of recurrent sarcomas is the existence of chemotherapy-resistant sarcoma stem cells.

Arms: arm 1: Single arm study: Dose escalation of temsirolimus plus constant dose of liposomal doxorubicin.
Interventions: intervention 1: temsirolimus plus liposomal doxorubicin
Intervention descriptions: intervention 1: Patients were treated with temsirolimus (Torisel) weekly by IV and with liposomal doxorubicin (Doxil) (standard dose) by IV once every 28 days. Cohorts of patients receive sequentially increasing dose of temsirolimus until dose limiting toxicity (DLT) occurred and the maximally tolerated dose (MTD) was identified. The MTD dose was the standard dose of temsirolimus used for the remainder of the study. Dose modifications were based on protocol parameters for toxicities.

Protocol documents:
Clinical trial NCT00965055
Conditions: High Cholesterol Coronary Artery Disease
Sponsor: University of California, San Diego
Start date: 2009-09-01; Completion date: 2012-09-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Response to statin therapy for elevated low density lipoprotein is variable and may be influenced by cholesterol absorption. This study will evaluate whether combination therapy with atorvastatin/ezetimibe will be superior to atorvastatin alone in subjects who have less than 25% LDL reduction on starting dose statin (eg, atorvastatin 10 mg daily or simvastatin 20 mg daily).

Detailed description:
Specific Aim 1 To identify a patient population seen in the University of California, San Diego general internal medicine and cardiology subspecialty clinics as well as referrals from community physicians who are hyporesponsive to statin therapy (defined as an initial LDL reduction of \<25% in response to 10mg of atorvastatin or 20mg of simvastatin- expected mean reduction is 35% -37% for starting dose simvastatin and atorvastatin).

Specific Aim 2 To test the hypothesis, with a prospective study, that a hyporesponse to statin therapy may be related to increased cholesterol absorption, and that this hyporesponse may be overcome by the addition of ezetimibe, a specific cholesterol absorption inhibitor.

Specific Aim 3 To evaluate whether patients with less than 25% LDL reduction on 10 mg of atorvastatin (or 20 mg of simvastatin) would achieve significantly greater LDL reduction with combination therapy (atorvastatin/ezetimibe) than with statin dose titration (using atorvastatin).

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ezetimibe intervention 2: Atorvastatin
Intervention descriptions: intervention 1: 10 mg intervention 2: Visit 1: (atorvastatin open label challenge): Those who complete the initial screening and washout period will receive open label atorvastatin 10 mg daily for 6 weeks to verify compliance and confirm hyporesponse to statin therapy.

Visit 2: After 6 weeks of therapy repeat baseline fasting cholesterol. Those with LDL-c reduction of 25% or less will be able to proceed to next phase. Patients with greater than 25% LDL-C reduction will be excluded. We expect to randomize 80 patients

Visit 2a: Dispensing of first randomized drug allocation- all patients receive open label atorvastatin 10 mg with additional ezetimibe 10 mg or matching placebo. No blood test during this visit.

Visit 3, 4, 5: Dose titration to atorvastatin to 20 mg, 40 mg, 80 mg, respectively, after fasting blood test

Blood collected in visits 3, 4, and 5 will be stored for additional tests regarding cholesterol metabolism and inflammation.

Visit 6: Final cholesterol panel and conclusion of study period

Protocol documents:
Clinical trial NCT00966654
Conditions: CABG
Keywords: CABG Cardiac Surgical Patient
Sponsor: Johns Hopkins University
Start date: 2008-09-01; Completion date: 2012-09-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This research is being done to see if giving a hormone called GLP-1 can improve heart function and reduce length of stay in the Cardiac Surgical Intensive Care Unit (CSICU) in people who have non-emergent coronary artery bypass graft (CABG) surgery.

Detailed description:
After CABG surgery, a condition known as hyperglycemia or high blood sugar often occurs even in patients who have never been diagnosed with diabetes. This high blood sugar can lead to complications after surgery such as infections at the site of the incision. Additionally, if there is any cardiac muscle injury either prior to or during surgery, the injured cardiac muscle can not use glucose (the body's fuel and energy source) as well as it did prior to the injury. This reduced ability to use glucose slows the cardiac muscles ability to repair itself and provide the normal pumping force and function needed to circulate the blood throughout the body. This inability to repair itself and/or provide the normal pumping force and function can make it difficult for the patient as well as increase the length of stay required in the CSICU.

GLP-1 has the ability to lower blood sugar and help cells use glucose for fuel and energy but when the blood sugar becomes low its glucose lowering ability decreases. In this study, we want to see we want to see if GLP-1 may help keep the blood sugar within normal limits and reduce or eliminate the need for insulin. We will also see whether it will help the heart recover more quickly.

Arms: arm 1: Saline arm 2: GLP-1 (7-36) amide
Interventions: intervention 1: Placebo intervention 2: GLP-1 (7-36) amide
Intervention descriptions: intervention 1: 1.5 pmol/kg/min (5 ng/kg/min) saline infused continuously over 72 hours. intervention 2: 1.5 pmol/kg/min (5 ng/kg/min) GLP-1 infused continuously over 72 hours.

Protocol documents:
Clinical trial NCT00984542
Conditions: Lung Cancer
Keywords: recurrent small cell lung cancer
Sponsor: Vanderbilt-Ingram Cancer Center
Start date: 2009-09-01; Completion date: 2012-09-01
Enrollment: 50 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
RATIONALE: Drugs used in chemotherapy, such as bendamustine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing.

PURPOSE: This phase II trial is studying how well bendamustine works as second- or third-line therapy in treating patients with relapsed or refractory small cell lung cancer.

Detailed description:
OBJECTIVES:

Primary

* To determine the time to progression in patients with relapsed or refractory small cell lung cancer treated with second- or third-line bendamustine.

Secondary

* To determine the toxicity of this drug in these patients.
* To determine the response rate, progression-free survival, and overall survival of patients treated with this drug.

OUTLINE: This is a multicenter study.

Patients receive bendamustine IV over 1 hour on days 1 and 2. Treatment repeats every 21 days for up to 6 courses in the absence of disease progression or unacceptable toxicity.

After completion of study treatment, patients are followed up every 6-8 weeks.

Arms: arm 1: None
Interventions: intervention 1: bendamustine hydrochloride
Intervention descriptions: intervention 1: Bendamustine 120 mg/m2 IV on days 1 and 2 of a 21-day treatment cycle

Protocol documents:
Clinical trial NCT01023217
Conditions: Hepatitis B, Chronic
Keywords: Chronic hepatitis B lamivudine adefovir entecavir
Sponsor: Asan Medical Center
Start date: 2009-11-01; Completion date: 2012-09-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The presence of persistent inadequate or suboptimal virologic response is a strong risk factor for viral resistance and breakthrough and also for disease progression of chronic hepatitis B, and thus, a change in therapy is required. The combination of entecavir (ETV) and adefovir (ADV) is a promising treatment for patients with lamivudine (LAM)-resistance who show suboptimal response to the combination of LAM and ADV.

In this randomized, open labeled trial,the investigators will compare the efficacy of continuation of ADV plus LAM versus switch to ADV plus ETV in adults with LAM-resistant chronic hepatitis B who shows suboptimal response to the combination treatment of ADV and LAM.

Detailed description:
In this randomized, open label, two-arm, single center phase IV trial, the investigators will assess and compare the efficacy and safety of continuation of ADV plus LAM versus switching to ADV plus ETV up to 52-weeks in Korean adults with chronic hepatitis B who have resistant mutants to LAM and show suboptimal response to combination of ADV plus LAM.

All study subjects who complete the initial treatments of 52-weeks will be thereafter treated with the combination of ADV plus ETV for 52 more weeks.

Study period: Nov 2009 - October 2012 Patient enrollment period: November 2009 - December 2010

Study protocol

1. Group A (ADV+LAM group): Adefovir (10 mg/day) + Lamivudine (100 mg/day) for 52 weeks, and thereafter, Adefovir (10 mg/day) + Entecavir (1 mg/day) for 52 more weeks
2. Group B (ADV+ETV group): Adefovir (10 mg/day) + Entecavir (1 mg/day) for 104 weeks

Arms: arm 1: Adefovir + Entecavir for 104 weeks arm 2: Adefovir + Lamivudine for 52 weeks, and thereafter, Adefovir + Entecavir for 52 more weeks
Interventions: intervention 1: Adefovir intervention 2: Entecavir intervention 3: Lamivudine
Intervention descriptions: intervention 1: Adefovir dipivoxil (Hepsera) 10 mg/day orally for 104 weeks intervention 2: Entecavir 1 mg/day orally intervention 3: Lamivudine (Zeffix) 100 mg/day orally

Protocol documents:
Clinical trial NCT01050257
Conditions: Influenza
Sponsor: Hoffmann-La Roche
Start date: 2010-01-01; Completion date: 2012-09-01
Enrollment: 118 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This partially randomized, multi-center parallel-group study will evaluate the safety, pharmacokinetics and the effect on viral load and viral shedding of Tamiflu (Oseltamivir) in patients with influenza. Adult and adolescent patients will be randomized to receive either 100 mg or 200 mg of study drug intravenously every 12 hours. Investigators and patients are blinded to knowledge of the assigned dose of Tamiflu. There is an option to convert to oral Tamiflu after 6 intravenous infusions. The anticipated time on study treatment is 5 days, with an optional treatment extension of a further 5 days, if necessary. There will be a non-randomized, open-label treatment group for patients with moderate/severe renal impairment or renal failure. Intravenous dose levels and frequency will be adjusted appropriately to their renal situation.

Detailed description:

Arms: arm 1: Oseltamivir (TAMIFLU®) 100 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 75 mg oral oseltamivir twice daily to complete the 5 days of treatment. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days. arm 2: Oseltamivir (TAMIFLU®) 200 mg intravenous (IV) infused over 2 hours, two times a day (every 12 hours) for 5 days. At the discretion of the investigator after 3 days of treatment (6 doses), participants could either continue IV treatment or switch to 150 mg oral oseltamivir twice daily for 5 days. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug (IV or oral) for up to 5 days. arm 3: Moderate/Severe renal impaired participants received open label oseltamivir IV or oseltamivir capsules at reduced doses for 5 days as per protocol. If necessary, after completing the 5 days of treatment, participants could receive additional treatment with study drug as per protocol.
Interventions: intervention 1: Oseltamivir IV intervention 2: Oseltamivir Oral
Intervention descriptions: intervention 1: Oseltamivir IV infusions over 2 hours two times a day (every 12 hours) for 5 days for patients with moderate renal impairment. Patients with severe renal impairment received once daily dosing and patients on renal replacement therapy received dose/frequency according to protocol. intervention 2: Oseltamivir (TAMIFLU®) capsules taken orally for 5 days. Twice daily (every 12 hours) for patients with moderate renal impairment, once daily for patients with severe renal impairment and dose frequency according to protocol for patients on renal replacement therapy.

Protocol documents:
Clinical trial NCT01082588
Conditions: Schizophrenia Schizoaffective Disorders Schizophreniform Disorders
Keywords: schizophrenia pravastatin inflammation cognition antipsychotics cholesterol
Sponsor: Massachusetts General Hospital
Start date: 2010-06-01; Completion date: 2012-09-01
Enrollment: 60 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study involves people with schizophrenia or schizoaffective disorder, who are currently taking antipsychotic medications. Some antipsychotic medications may cause an increase in cholesterol levels, which may lead to inflammation in the body. Inflammation poses a risk in developing heart disease, diabetes and problems with brain function. The purpose of this study is to see if pravastatin can:

* Lower cholesterol
* Decrease inflammation
* Improve cognition in patients with schizophrenia

Detailed description:
This study is a 12-week randomized, double-blind, placebo-controlled pilot study of pravastatin 40mg a day, administered for 12 consecutive weeks to subjects with schizophrenia to examine pravastatin's effects on lowering cholesterol levels and inflammatory markers, and improving cognition. The study will be conducted at the Freedom Trail Clinic and will use the Massachusetts General Hospital Clinical Research Center. The innovative approach of using pravastatin to not only decrease cholesterol levels, but to decrease inflammation and improve cognition in patients with schizophrenia is promising and may lead to a different approach to treatment in this population.

Arms: arm 1: pravastatin 40mg, once a day, shortly after baseline for 12 consecutive weeks arm 2: placebo, once a day, shortly after baseline for 12 consecutive weeks
Interventions: intervention 1: Pravastatin intervention 2: Placebo
Intervention descriptions: intervention 1: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks intervention 2: pravastatin 40mg, or placebo, once a day, shortly after baseline for 12 consecutive weeks

Protocol documents:
Clinical trial NCT01096290
Conditions: Constipation
Keywords: constipation lubiprostone healthy volunteers
Sponsor: University of South Alabama
Start date: 2010-04-01; Completion date: 2012-09-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Constipation from medications is a serious and common condition. Lubiprostone has properties that make it a candidate drug. One hundred volunteers with constipation who are taking medications known to cause constipation will be randomized to take lubiprostone or placebo for 28 days. Therapeutic outcome will be evaluated by investigator and study subject assessment.

Detailed description:
Lubiprostone is a novel chloride channel activator that increases intestinal fluid secretion and motility. It is FDA approved and indicated for treatment of chronic idiopathic constipation and recently, constipation-predominant irritable bowel syndrome.

The Physicians Desk Reference lists over 90 Brand medications with reported incidence associated with constipation over 3%. Little data are available about treatment responses. A recent publication by our group reported treatment success for medication constipation using polyethylene glycol. Since ongoing studies are addressing the role of lubiprostone in opioid constipation, this work will be enrolling medication constipation study subjects not using opioids.

In this study, patients who meet diagnostic criteria for constipation will be randomized to receive 28 days of treatment with lubiprostone 24mcg twice a day. Data will be collected to evaluate therapeutic outcome.

Arms: arm 1: Active medication arm 2: Placebo, matched, blinded
Interventions: intervention 1: lubiprostone intervention 2: Matched placebo
Intervention descriptions: intervention 1: 24mcg BID, capsule, oral 30days intervention 2: Twice daily for 30days, oral

Protocol documents:
Clinical trial NCT01109524
Conditions: Lung Neoplasms Carcinoma Cancer of the Lung Non-Small-Cell Lung Carcinoma
Sponsor: Eli Lilly and Company
Start date: 2010-07-01; Completion date: 2012-09-01
Enrollment: 72 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine if U.S. manufactured Cetuximab can be safely used for the treatment of Non-Small Cell Lung Cancer in combination with Cisplatin and Vinorelbine.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Cetuximab intervention 2: Cisplatin intervention 3: Vinorelbine
Intervention descriptions: intervention 1: Vial, Intravenous, 400mg/m², week 1, then 250mg/m², Weekly, Until Progressive Disease (PD)/ Toxicity/Pt-PI Decision intervention 2: Vial, Intravenous, 80mg/m², Day 1 of each 21 day cycle, Maximum 6 cycles intervention 3: Vial, Intravenous, 25 mg/m², Day 1 and 8 of each 21 day cycle, Maximum 6 cycles

Protocol documents: