ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00440232
Conditions: Migraine
Sponsor: Thomas Jefferson University
Start date: 2007-07-01; Completion date: 2009-09-01
Enrollment: 74 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
We are testing the hypothesis that subjects in the treatment group will experience fewer fasting induced headaches as compared to those in the placebo group.In our clinical experience, we estimate that approximately 25% of our headache population experiences fasting-induced migraine or hunger-induced migraine. With a given migraine incidence of 28 million in the United States alone, we estimate that approximately 7 million will experience hunger as a migraine trigger. If an individual has a known migraine trigger, then there are a variety of ways to modify care in order to address that trigger. The simplest is to avoid that trigger or preemptively treat that trigger. Frovatriptan has good evidence for daily use for a short time to help prevent menstrually related migraines. A short course of treatment can often avoid the initiation of the migraine and improve quality of life. Knowing that a longer acting triptan, such as frovatriptan, has demonstrated capability at suppressing headache through a known trigger, suggests the need to study this with fasting induced migraines, as well.

Detailed description:

Arms: arm 1: 5.0 mg of Frovatriptan given as single dose arm 2: None
Interventions: intervention 1: Frovatriptan intervention 2: Placebo
Intervention descriptions: intervention 1: Frovatriptan 5.0 mg orally one time at the start of the 20 hour fast intervention 2: Inert tab identical in appearance to Frovatriptan

Protocol documents:
Clinical trial NCT00447226
Conditions: Cancer
Keywords: Ovarian Cancer Bladder Cancer ErbB2 positive Lapatinib Gastric/Esophageal Cancer Uterine Serous Papillary Cancer
Sponsor: GlaxoSmithKline
Start date: 2007-05-01; Completion date: 2009-09-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will examine the efficacy and safety of lapatinib in patients with ErbB2 positive ovarian, gastric/esophageal adenocarcinoma, uterine serous papillary, or bladder cancers.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Oral lapatinib tablets or placebo tablets
Intervention descriptions: intervention 1: Subjects administered open label lapatinib, 1500 mg to be taken orally once a day, for 12 weeks. After 12 weeks, subjects with a partial or complete response per Response Evaluation Criteria in Solid Tumors (RECIST) will continue to receive open label lapatinib (1500 mg/day orally) until disease progression. Subjects who maintain stable disease will be randomized in a 1:1 ratio to enter stage 2 of the study and receive double blind therapy of either lapatinib 1500 mg/day orally or placebo. Subjects who progress on placebo will have the option to receive lapatinib 1500 mg/day orally until further progression. Those who progress on lapatinib will be withdrawn from the study.

Protocol documents:
Clinical trial NCT00464711
Conditions: Major Depressive Disorder
Keywords: depression biology
Sponsor: Massachusetts General Hospital
Start date: 2006-09-01; Completion date: 2009-09-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will evaluate changes in brain gamma-aminobutyric acid (GABA) levels due to treatment with escitalopram in people with major depressive disorder.

Detailed description:
Major depressive disorder (MDD) is a severe form of depression. MDD can significantly interfere with an individual's thoughts, behavior, mood, and physical health. People who suffer from MDD often experience feelings of worthlessness; they may feel hopeless and may be unable to cope with problems in their life. In addition, they often experience sleep disruption, loss of appetite, and chronic pain.

The purpose of the study is to compare images taken of the brains of people who are depressed and the brains of healthy volunteers. Specifically, we want to see if symptoms of depression are related to a decrease in a brain chemical called GABA. We measure the concentration of GABA using a brain-scanning device called "magnetic resonance spectroscopy" (or "MRS"), which is a type of MRI.

The study lasts for 14 weeks and involves 8 visits to our MGH clinic in Boston. The first visit is the screening visit, which can last up to 3 hours. The rest of the visits are about a half hour long and take place every other week. In addition to these 8 visits, there are also 2 visits to McLean Hospital Brain Imaging Center for the MRS scans. The first scan takes place within a few days after the screening visit, and the second scan will be at the end of the 14 weeks. Each scan visit lasts between an hour and a half and two hours. Subjects are reimbursed $50 per MRS scan and $25 per visit to McLean to cover travel costs.

All subjects in this study will receive escitalopram (or Lexapro), which is an antidepressant medication approved by the Food and Drug Administration. Subjects start at 10 mg daily of the escitalopram, but may be increased up to 30 mg if the study doctor thinks it is appropriate.

Arms: arm 1: single arm
Interventions: intervention 1: Escitalopram
Intervention descriptions: intervention 1: Dose determined per clinical discretion. All participants begin on 10mg po qd of escitalopram, and can increase the dose to 30mg po qd over the 12 weeks of the study.

Protocol documents:
Clinical trial NCT00475878
Conditions: Opiate Dependence Depression
Keywords: opiate use depression buprenorphine escitalopram
Sponsor: Butler Hospital
Start date: 2006-12-01; Completion date: 2009-09-01
Enrollment: 147 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to test whether treatment of depressive symptoms using escitalopram improves adherence to Buprenorphine and reduces symptoms of depression for individuals receiving Buprenorphine through their medical provider.

Detailed description:
Participants interested in receiving Buprenorphine will be offered the opportunity to enroll in this study. Enrolled study participants will complete interviews at baseline and again every two weeks for a total of 8 interviews over 3 months. In this double-blind randomized controlled trial, participants will either receive a placebo or escitalopram (10mg). All participants will also be followed by their Buprenorphine clinic medical provider. Questions during the face-to-face interviews will assess mood, drug craving, pain, sleep, medication adherence and drug-related experiences. Comparison(s): Participants randomized into the medication component of the study as compared to participants randomized into the placebo component of the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: escitalopram intervention 2: placebo
Intervention descriptions: intervention 1: 10mg escitalopram/day for 3 months intervention 2: placebo capsule/day for 3 months

Protocol documents:
Clinical trial NCT00488345
Conditions: Bacterial Infections Intra-Abdominal Infection Pneumonia, Bacterial Skin Diseases, Bacterial Skin Diseases, Infectious
Keywords: cIAI cSSSI CAP Child
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2007-12-01; Completion date: 2009-09-01
Enrollment: 59 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the pharmacokinetic profile and to evaluate the safety and tolerability of ascending multiple doses of tigecycline in patients aged 8 to 11 years with selected serious infections; complicated intra-abdominal infections (cIAI), complicated skin and skin structure infections (cSSSI), or community-acquired pneumonia (CAP).

Detailed description:

Arms: arm 1: 0.75 mg/kg (up to a maximum dose of 50 mg for each dose) of tigecycline every 12 hours infused over approximately 30 minutes. Escalation to next dose cohort will occur only after safety and tolerability at preceding dose have been established by sponsor (after tigecycline LDOT data are received) and if at least 5 of 6 PK samples per patient have been received by central laboratory in acceptable condition for 10 to 12 patients in cohort. Treatment period of tigecycline will be a minimum of 3 days (unless patient is considered a treatment failure before this time) and a maximum of 14 days. On or after Day 4, based on investigator's decision, patients can switch to oral antibiotic therapy (to be chosen and provided by the investigator) and discharged after collection of planned PK samples. arm 2: 1 mg/kg (up to a maximum dose of 50 mg for each dose) of tigecycline every 12 hours infused over approximately 30 minutes. Escalation to next dose cohort will occur only after safety and tolerability at preceding dose have been established by sponsor (after tigecycline LDOT data are received) and if at least 5 of 6 PK samples per patient have been received by the central laboratory in acceptable condition for 10 to 12 patients in the cohort. Treatment period of tigecycline will be a minimum of 3 days (unless the patient is considered a treatment failure before this time) and a maximum of 14 days. On or after Day 4, based on investigator's decision, patients can switch to oral antibiotic therapy (to be chosen and provided by the investigator) and discharged after collection of planned PK samples. arm 3: 1.25 mg/kg (up to maximum dose of 50 mg for each dose) of tigecycline every 12 hours infused over approximately 30 minutes. Treatment period of tigecycline will be a minimum of 3 days (unless patient is considered a treatment failure before this time) and a maximum of 14 days. On or after Day 4, based on investigator's decision, patients can switch to oral antibiotic therapy (to be chosen and provided by the investigator) and discharged after collection of planned PK samples.
Interventions: intervention 1: Tygacil
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00506441
Conditions: Chronic Kidney Disease Dialysis Hyperphosphatemia
Keywords: Chronic Kidney Disease Dialysis Hyperphosphatemia Phosphate binder
Sponsor: Mitsubishi Tanabe Pharma Corporation
Start date: 2007-09-01; Completion date: 2009-09-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a phase III multi-centre study in three periods: the first period is a phosphate binder washout for 4 weeks, the second period is an open-label, flexible dose titration, the third period is a placebo-controlled withdrawal comparing MCI-196 with placebo for 4 weeks.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MCI-196 intervention 2: Placebo
Intervention descriptions: intervention 1: 3g to 15g/day (3 times a day), Tablet, 12 weeks of flexible dose (Open-label) and 4 weeks of double blind intervention 2: 3g to 15g/day (3 times a day), Tablet, 4 weeks of double blind

Protocol documents:
Clinical trial NCT00518284
Conditions: Vascular Disease, Peripheral
Keywords: Restenosis Superficial Femoral Artery Prevention of restenosis Revascularization of the superficial Femoral Artery
Sponsor: Celgene Corporation
Start date: 2008-01-01; Completion date: 2009-09-01
Enrollment: 6 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the prevention of Restenosis following Revascularization of the superficial Femoral Artery (SFA)

Detailed description:

Arms: arm 1: Following revascularization, participants did not receive any study drug treatment. arm 2: Participants received an initial intraarterial infusion (proximal to the lesion) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization, and a follow-up intravenous injection of 45 mg/m\^2 at 7 days. arm 3: Participants received an initial intraarterial infusion (during flow arrest) of 45 mg/m\^2 nanoparticle paclitaxel immediately following revascularization. arm 4: Participants received an initial intraarterial infusion (during flow arrest) of 45mg/m\^2 nanoparticle paclitaxel immediately following revascularization and a follow-up intravenous injection of 45 mg/m\^2 at 7 days.
Interventions: intervention 1: Nanoparticle Paclitaxel
Intervention descriptions: intervention 1: Nanoparticle albumin-bound paclitaxel, 45 mg/m\^2.

Protocol documents:
Clinical trial NCT00521885
Conditions: Venous Thrombosis
Keywords: Bleeding rates Prophylaxis for deep vein thrombosis
Sponsor: Lehigh Valley Hospital
Start date: 2007-09-01; Completion date: 2009-09-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A total of 50 patients \>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer will be enrolled. The patient and study team will be blinded to which drug they are receiving (either Arixtra or Lovenox). Subjects will be examined for any bleeding complications. Subjects will receive drug for a total of 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after discharge from the hospital.

Detailed description:
A total of 50 patients will be enrolled in this double-blinded, randomized, controlled trial. Inclusion criteria: subjects\>40 yrs of age with an expected hospital stay in the Medical Intensive Care or Regional Heart Unit at LVH Muhlenberg of 6 days or longer (4 days bedridden) will be enrolled. Total drug treatment will be 6-14 days while in the hospital. A follow up phone call will be performed by the study team approximately 30 days after hospital discharge. Primary endpoint: bleeding rate (minor vs major) between study days 1-14. Secondary endpoint: DVT study days 1-14 (confirmed with LE duplex ultrasonogram).

Arms: arm 1: Arixtra (Fondaparinox) 2.5 mg SC Daily arm 2: Lovenox 40mg SC Daily
Interventions: intervention 1: Arixtra (Fondaparinox) 2.5 mg SC Daily intervention 2: Lovenox 40mg SC Daily
Intervention descriptions: intervention 1: Patients will be randomized to receive Arixtra 2.5mg once a day if randomized to this arm intervention 2: Patients will be randomized to receive Lovenox 40mg SC Daily if randomized to this arm

Protocol documents:
Clinical trial NCT00529243
Conditions: HIV Infections
Keywords: Treatment Experience On enfuvirtide
Sponsor: Kaiser Permanente
Start date: 2007-09-01; Completion date: 2009-09-01
Enrollment: 52 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The primary objective of this study is:

To assess the virologic effect of changing enfuvirtide to MK-0518(raltegravir) in human immunodeficiency virus type 1(HIV-1) infected patients who have an undetectable level of serum human immunodeficiency virus(HIV) (\< 75 copies/ml by branch deoxyribonucleic acid (bDNA) assay, \< 50 copies/ml by Ultrasensitive Polymerase Chain Reaction(PCR) assay) on their current HIV medication regimen.

Hypothesis:

HIV-1 infected individuals well controlled on an enfuvirtide containing regimen with HIV RNA levels below limits of quantification can safely have the investigational integrase inhibitor, MK-0518 substituted for enfuvirtide without loss of virologic suppression.

Detailed description:
Human immunodeficiency virus type 1(HIV-1) infected patients who have had an undetectable viral load on an enfuvirtide containing regimen at the Kaiser Permanente Hayward, Los Angeles, San Francisco, and Santa Clara Medical Centers will be enrolled. Patients will receive open label MK-0518 (raltegravir) 400mg orally twice a day as substitution for enfuvirtide for 24 weeks.

Arms: arm 1: Open label, single arm. All patients to receive MK-0518 400mg orally twice a day for 24 weeks, as substitution for enfuvirtide.
Interventions: intervention 1: raltegravir
Intervention descriptions: intervention 1: This is a single-arm, open-label, non-randomized pilot study in human immunodeficiency virus type 1 (HIV-1) positive patients who have an undetectable viral load on their current enfuvirtide containing medication regimen. The treatment regimen will consist of replacing enfuvirtide with MK-0518 400 mg twice a day given as part of the patient's HIV medication regimen. The study regimen will be administered for 24 weeks, with patients given the option of continuing on the study medication past that time if they wish to. Patients serve as their own control as they have viral control (HIV ribonucleic acid (RNA) below limits of quantification) for at least 6 months with enfuvirtide prior to switch to raltegravir.

Protocol documents:
Clinical trial NCT00550680
Conditions: Chronic Renal Anemia
Sponsor: Hoffmann-La Roche
Start date: 2008-01-01; Completion date: 2009-09-01
Enrollment: 208 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This single-arm study will assess the efficacy and safety of intravenous (IV) Mircera when administered for the maintenance of hemoglobin (Hb) levels in participants with chronic renal anemia. Individuals currently receiving maintenance treatment with epoetin alfa or darbepoetin alfa will receive monthly injections of Mircera, with the starting dose (120, 200, or 360 micrograms \[mcg\] IV injection) derived from the dose of epoetin alfa or darbepoetin alfa they were receiving in the week preceding study start.

Detailed description:

Arms: arm 1: Participants with chronic renal anemia who have been previously treated with erythropoiesis-stimulating agent (ESA) therapy will receive IV Mircera every 4 weeks for a total of 24 weeks in this single-arm study. The first dose of 120, 200, or 360 mcg will be determined by the dose of ESA received prior to administration of study treatment. Subsequent doses will be adjusted to maintain Hb concentrations within target of 10.5 and 12.5 grams per deciliter (g/dL).
Interventions: intervention 1: Methoxy polyethylene glycol-epoetin beta
Intervention descriptions: intervention 1: Participants will receive a starting dose of 120, 200, or 360 mcg via IV injection. Thereafter, the once-monthly dose will be titrated to achieve target Hb concentrations.

Protocol documents:
Clinical trial NCT00551135
Conditions: Pain, Postoperative Hernia, Inguinal
Keywords: postoperative pain chronic pain
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2008-01-01; Completion date: 2009-09-01
Enrollment: 425 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test whether pregabalin added to the standard of care with dosing starting preoperatively and continuing for 1 week post surgery will decrease the intensity of acute post-operative pain following inguinal hernia repair.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Pregabalin intervention 2: placebo intervention 3: Pregabalin intervention 4: Pregabalin
Intervention descriptions: intervention 1: 150 mg BID intervention 2: Placebo intervention 3: 75 mg BID intervention 4: 25 mg BID

Protocol documents:
Clinical trial NCT00567008
Conditions: Cocaine Dependence
Keywords: cocaine crack cocaine cocaine-related disorders substance-related disorders alpha4beta2 nicotinic acetylcholine receptor
Sponsor: University of Pennsylvania
Start date: 2007-12-01; Completion date: 2009-09-01
Enrollment: 37 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether varenicline (Chantix), is effective for the treatment of cocaine dependence.

Detailed description:
The purpose of study is to determine if Varenicline (Chantix™) promotes cocaine abstinence in cocaine dependent individuals. Varenicline (Chantix™) (2.0 mg/day) or placebo will be administered in a 9-week double-blind trial to patients meeting diagnostic criteria for cocaine dependence.

Arms: arm 1: Varenicline (Chantix) arm 2: Placebo
Interventions: intervention 1: varenicline intervention 2: placebo
Intervention descriptions: intervention 1: 1.0 mg BID for 8 weeks intervention 2: placebo BID for 8 weeks

Protocol documents:
Clinical trial NCT00573313
Conditions: Liver Disease, Alcoholic
Keywords: Alcoholic Liver Disease (ALD) S-adenosylmethionine SAMe
Sponsor: University of California, Davis
Start date: 2005-09-01; Completion date: 2009-09-01
Enrollment: 94 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Prior studies in animal models have established that the pathogenesis of alcoholic liver disease (ALD) is regulated in part by the effects of chronic alcohol abuse on hepatic methionine metabolism. The hypothesis of the clinical study was that provision of the methionine metabolite S-adenosylmethionine (SAM) would correct abnormal hepatic methionine metabolism thereby effectively treating ALD. The two goals of the clinical research were a)to determine the clinical relationship of aberrant hepatic methionine metabolism to ALD by comparisons of patterns of serum methionine metabolites in groups of ALD patients, alcoholics without liver disease, and normal healthy subjects, and b) to determine the treatment effects of SAM on patterns of serum methionine metabolites and on the histopathology and biochemical features of liver injury in ALD patients.

Detailed description:
We assessed a total of 297 potential ALD candidates, from whom 40 were enrolled in the study. In addition, we enrolled 26 gender matched active alcohol drinkers without liver disease (AD) and 28 age and gender matched healthy control subjects (HS). Of the original 40 ALD subjects who provided initial enrollment data, 3 declined to proceed with the trial. Therefore, 37 ALD patients were randomized to receive SAM at a dose of 400 mg or placebo three times daily for 24 weeks. However 11 of these dropped out after initial evaluation, leaving 26 ALD patients, 13 in each arm, who completed the 24 week trial.

Arms: arm 1: Alcoholic liver disease patients receiving S-adenosylmethionine (SAMe)at 400 mg capsule three times daily for 24 weeks arm 2: ALD subjects receiving Placebo three times daily for 24 weeks.
Interventions: intervention 1: S-adenosylmethionine intervention 2: Placebo
Intervention descriptions: intervention 1: Alcoholic liver disease patients received drug at dose of 400 mg three times daily for 24 weeks. intervention 2: Alcoholic liver disease patients received identical size and shape sugar pill placebo three times daily for 24 weeks.

Protocol documents:
Clinical trial NCT00592488
Conditions: Septic Shock
Keywords: Septic shock Acetyl-L-carnitine
Sponsor: Vanderbilt University
Start date: 2006-08-01; Completion date: 2009-09-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This placebo-controlled study investigates acetyl-L-carnitine in the treatment of septic shock requiring vasopressors.

Detailed description:
This is a cross-over study which infuses ALC for 12 out of 18 hours (and placebo the other 6). Patients must have vasopressor-dependent septic shock and be free from renal failure, hepatic failure, and seizures to be eligible.

Arms: arm 1: Placebo for first 6 hours then Acetyl-L-Carnitine (ALC) for 12 hours arm 2: Acetyl-L-Carnitine (ALC) for first 12 hours then placebo for next 6 hours
Interventions: intervention 1: Acetyl-L-Carnitine
Intervention descriptions: intervention 1: Acetyl-L-Carnitine - 4 g IV over 30 minutes, then 8 g iv over the next 12 hours

Protocol documents: