ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01208402
Conditions: High-risk, Non-cardiovascular Surgeries
Sponsor: Duke University
Start date: 2010-09-01; Completion date: 2013-07-01
Enrollment: 76 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to find out if Esmolol is a safe and effective alternative treatment compared to standard treatment using a long acting beta blocker drug, in controlling abnormal heart rate before, during and immediately after surgery.

Detailed description:
The benefit versus risk of perioperative beta blockade therapy for adverse ischemic event risk reduction in high risk patients undergoing non-cardiac surgery has been recently challenged. In particular the PeriOperative Ischemia Study Evaluation (POISE trial) showed a cardio-protective effect only at the expense of a higher incidence of stroke and all-cause mortality . In that study death and stroke were significantly associated with an increase in hypotension and bradycardia. Long acting agents - aggressively administered to achieve heart rate (HR) control - appear to be associated with significant adverse outcomes (death, stroke) despite myocardial ischemia and infarction reduction.

It is estimated that 20 percent of high risk patients come to surgery with chronic beta blocker oral therapy. The American Heart Association recommends continuation of beta blockers in this situation as beta-blocker withdrawal is associated with increased rate of perioperative myocardial infarction . Protocols optimizing the perioperative administration of beta-blockers in high-risk patients are therefore needed.

Esmolol is a cardioselective beta-blocker with a short elimination half-life (t1/2 = 9.2 min) and no intrinsic sympathomimetic activity. Evidence has revealed that Esmolol, with its unique short half life can be quickly titrated to both achieve a target hemodynamic effect as well as reduce (or loose) its effect quickly in unstable situations thereby mitigates undesired hypotension and / or bradycardia.

This study proposes to assess the Safety and Efficacy of dosing to target endpoints with Esmolol - an ultra short acting beta blocker - the day of surgery compared to standard long acting oral Metoprolol the day of surgery.

Arms: arm 1: oral administration of long acting beta blocker as standard of care on the day of surgery arm 2: given 30 minutes prior to induction up to 12 hours post-op
Interventions: intervention 1: Esmolol
Intervention descriptions: intervention 1: Infusion will be started at 50 mcg/kg/min for 4 minutes and titrated in increments of 50 mcg/kg/min up to a maximum of 300mcg/kg/min (maintenance dose) to maintain a heart rate between 60 and 80 beats per minute (bpm) while maintaining a minimum systolic blood pressure (SBP) of 95 mmHg during the length of surgery and up to 12 hours post-operatively.

Protocol documents:
Clinical trial NCT01239992
Conditions: Hyperlipoproteinemia Metabolic Syndrome
Sponsor: Ludwig-Maximilians - University of Munich
Start date: 2011-06-01; Completion date: 2013-07-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study is designed to evaluate the effect of Niacin/Laropiprant on postprandial lipoprotein metabolism, postprandial glucose metabolism, postprandial monocyte function, and postprandial biomarkers of endothelial dysfunction and inflammation.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Niacin/ Laropiprant
Intervention descriptions: intervention 1: 1000/ 20 mg first 4 weeks, 2000/40 mg next 8 weeks; daily

Protocol documents:
Clinical trial NCT01244633
Conditions: Tourette's Syndrome
Keywords: Tourette's Ecopipam Dopamine receptors Efficacy Safety Adults
Sponsor: Psyadon Pharma
Start date: 2010-10-01; Completion date: 2013-07-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Tourette's Syndrome is a neurological disease characterized by verbal and motor tics. The currently available drug treatments are considered to be inadequate. This clinical trial is designed to test if ecopipam is effective for the treatment of Tourette's Syndrome in adults.

Detailed description:
Tourette's Syndrome is a neurological disease characterized by verbal and motor tics. Although its causes are unknown, many researchers believe that changes in brain chemicals (called neurotransmitters) are critically involved. One of these neurotransmitters is called dopamine, and it exerts its actions through its receptors (called D1-type or D2-type). It has been suggested that the symptoms of Tourette's Syndrome are due to an overactivity at the D1-type receptor. Ecopipam is a selective antagonist of the D1-type receptors. The present clinical trial is designed to test if ecopipam is able to relieve the symptoms of the disease in adults patients with Tourette's Syndrome. Eligible patients will be treated for eight weeks.

Arms: arm 1: Active treatment
Interventions: intervention 1: Ecopipam
Intervention descriptions: intervention 1: 50 or 100 mg tablets given once per day for eight weeks

Protocol documents:
Clinical trial NCT01248364
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2010-11-01; Completion date: 2013-07-01
Enrollment: 91 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
An open-label, phase II study to assess the acute and chronic effects of empagliflozin (BI 10773)on fasting and postprandial glucose homeostasis in patients with IGT and type 2 diabetes mellitus and assess the acute effects of empagliflozin in healthy subjects.

Detailed description:

Arms: arm 1: BI 10773 high dose once daily
Interventions: intervention 1: BI 10773
Intervention descriptions: intervention 1: BI 10773 tablets once daily high dose

Protocol documents:
Clinical trial NCT01249274
Conditions: Cocaine Abuse Cocaine Dependence
Keywords: cocaine abuse cocaine dependence postpartum period
Sponsor: Yale University
Start date: 2011-02-01; Completion date: 2013-07-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The investigators propose a placebo-controlled, randomized clinical trial that would enroll 50 postpartum women with a history of cocaine abuse or dependence to assess whether progesterone (100mgs twice daily) decreases postpartum cocaine use.

Detailed description:
Specific Aim 1: To evaluate whether postpartum women with a history of cocaine abuse or dependence use less cocaine if they are randomized to progesterone than placebo.

Hypothesis 1: Compared to women who are randomized to placebo, those assigned to progesterone will use less cocaine as measured by urine toxicology results and self-reported days of use.

Specific aim 2: To obtain information about the safety and tolerability of progesterone treatment in the postpartum period.

Hypothesis 2: Side effects for progesterone will be similar to those of placebo.

Arms: arm 1: Matched placebo pills to be taken twice daily arm 2: 100 mgs progesterone twice daily
Interventions: intervention 1: Progesterone intervention 2: Placebo
Intervention descriptions: intervention 1: 100mgs progesterone twice daily intervention 2: Matched placebo pills to be taken twice daily

Protocol documents:
Clinical trial NCT01275625
Conditions: HIV
Keywords: maraviroc naive hiv zidovudine lamivudine combivir Clade A
Sponsor: ViiV Healthcare
Start date: 2011-06-01; Completion date: 2013-07-01
Enrollment: 98 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
One hundred subjects in Russia will be treated with a combination of Combivir (zidovudine and lamivudine) and maraviroc as their first line HIV therapy. The aim is to assess the efficacy and safety of this combination in a Russian population of patients.

Detailed description:

Arms: arm 1: Single arm study of combivir and maraviroc for 48 weeks
Interventions: intervention 1: HIV therapy
Intervention descriptions: intervention 1: Combivir one tablet BD with maraviroc 300mg BD for 48 weeks

Protocol documents:
Clinical trial NCT01295814
Conditions: Interstitial Cystitis
Keywords: Interstitial cystitis Humira Adalimumab
Sponsor: ICStudy, LLC
Start date: 2011-03-01; Completion date: 2013-07-01
Enrollment: 43 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate an investigational treatment for interstitial cystitis. Interstitial cystitis is a chronic bladder disease that includes the following symptoms: Urinary frequency during the day,urinary frequency at night, urinary urgency and bladder discomfort relieved by voiding.

Presently, there is no cure for interstitial cystitis. The response to current treatments is poor. Patients with interstitial cystitis have a poorer quality of life. The cause of interstitial cystitis is unknown. This study is evaluating the drug Humira® (adalimumab) for improving the symptoms of patients with interstitial cystitis. Humira® is an injectable anti-inflammatory medication that has been available for use since December 31, 2002. Humira® has been FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases have similar characteristics to interstitial cystitis. This study will evaluate an investigational use of Humira® for the treatment of interstitial cystitis.

Detailed description:
Interstitial cystitis (IC) is a chronic disabling bladder syndrome characterized by urinary frequency, nocturia, urinary urgency, and pain with bladder filling-relieved by emptying. There is no cure for IC and the treatment options are suboptimal. Patients with IC report significant negative effects on their physical and mental quality of life. The etiology of IC is unknown. Certain aspects of IC suggest that autoimmunity may play a role in initiating or sustaining the chronic inflammatory response. Bladder biopsies of patients with IC demonstrate an increase number of mast cells. Mast cell activation with the release of tumor necrosis factor (TNF) may mediate this bladder inflammation. Humira® (adalimumab) is a medication that blocks the effect of TNF. Humira® (adalimumab) is FDA approved for the treatment of rheumatoid arthritis, psoriasis, ankylosing spondylitis, and Crohn's disease. These diseases are similar to IC. In this study, the hypothesis being tested is that Humira® (adalimumab) will show efficacy at reducing the symptoms of IC.

Arms: arm 1: Adalimumab 80mg subcutaneous loading dose followed by 40 mg subcutaneous every 2 weeks for 12 weeks arm 2: Placebo in identical syringe subcutaneous every 2 weeks for 12 weeks
Interventions: intervention 1: Adalimumab intervention 2: inactive drug
Intervention descriptions: intervention 1: 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period intervention 2: 80 mg loading dose given subcutaneously followed by 40 mg dose given subcutaneously every two weeks over a twelve week period

Protocol documents:
Clinical trial NCT01305408
Conditions: Depression
Keywords: Bipolar I Disorder
Sponsor: Cephalon
Start date: 2011-03-01; Completion date: 2013-07-01
Enrollment: 399 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of the study is to determine whether armodafinil treatment, at a dosage of 150 mg/day, is more effective than placebo treatment as adjunctive therapy to mood stabilizers for treatment of adults with major depression associated with bipolar I disorder.

Detailed description:

Arms: arm 1: Participants began taking placebo to match armodafinil and following the same titration procedure. Treatment was administered for a total of 8 weeks. arm 2: Participants began taking armodafinil at a dosage of 50 mg/day; the dosage was increased by 50 mg/day on days 2 and 4, up to a dosage of 150 mg/day. Treatment was administered for a total of 8 weeks.
Interventions: intervention 1: Armodafinil intervention 2: Placebo
Intervention descriptions: intervention 1: Armodafinil tablets, taken orally, once daily in the morning intervention 2: Matching placebo tablets, taken orally, once daily in the morning

Protocol documents:
Clinical trial NCT01314716
Conditions: Bronchiectasis
Sponsor: Gilead Sciences
Start date: 2011-04-01; Completion date: 2013-07-01
Enrollment: 274 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The AIR-BX2 study enrolled people with non-cystic fibrosis (non-CF) bronchiectasis and gram-negative airway infection. Participants received two 28-day courses of either Aztreonam for Inhalation Solution (AZLI) or placebo taken 3 times a day. Each course was followed by a 28-day off-drug period. Following the two blinded courses, all participants received a 28-day course of open-label AZLI then were followed for an additional 56 days.

Detailed description:

Arms: arm 1: Participants were randomized to receive blinded AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up. arm 2: Participants were randomized to receive blinded placebo to match AZLI for 2 cycles of 28 days on treatment with each cycle followed by 28 days off treatment, followed by open-label AZLI for 28 days plus 56 days of treatment-free follow-up.
Interventions: intervention 1: AZLI intervention 2: Placebo
Intervention descriptions: intervention 1: AZLI 75 mg reconstituted with diluent and administered via nebulizer three times daily intervention 2: Placebo to match AZLI administered via nebulizer three times daily

Protocol documents:
Clinical trial NCT01317641
Conditions: Prostate Cancer
Sponsor: Orion Corporation, Orion Pharma
Start date: 2011-03-01; Completion date: 2013-07-01
Enrollment: 136 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate safety, tolerability and pharmacokinetics of ODM-201 in patients with castrate resistant prostate cancer.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: ODM-201
Intervention descriptions: intervention 1: ODM-201 administered orally daily

Protocol documents:
Clinical trial NCT01349790
Conditions: Primary Thrombocytopenia
Keywords: ITP Primary immune thrombocytopenia
Sponsor: Octapharma
Start date: 2011-10-01; Completion date: 2013-07-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
NewGam is a newly developed human normal immunoglobulin solution for intravenous administration (IGIV). This study will evaluate the safety and efficacy of NewGam 10% in patients with primary immune thrombocytopenia.

Detailed description:
The primary objective of the study is to assess the efficacy of NewGam in correcting the platelet count. The secondary objective of the study is to evaluate the safety of NewGam. Safety will be assessed by monitoring vital signs, physical examination, evaluation of adverse events (AE) and laboratory parameters, and viral safety testing.

Arms: arm 1: Each participant received 1 g/kg NewGam intravenously on 2 consecutive days.
Interventions: intervention 1: NewGam
Intervention descriptions: intervention 1: NewGam is a solution of human normal immunoglobulin 10% treated with solvent/detergent and nanofiltered for intravenous administration.

Protocol documents:
Clinical trial NCT01355302
Conditions: Advanced or Metastatic Solid Tumors Previously Untreated Gastric Cancer
Keywords: Cancer Solid Tumors Gastric Phase I Phase II
Sponsor: Eisai Inc.
Start date: 2011-11-01; Completion date: 2013-07-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the following: 1. Find the maximum tolerated dose of E7050 when given in combination with cisplatin and capecitabine in patients with advance or metastatic solid tumors, and 2) Whether E7050 in combination with cisplatin and capecitabine is more effective in patients with previously untreated gastric cancer versus cisplatin and capecitabine alone.

Detailed description:
This open-label, multicenter, randomized study will consist of 2 phases:

Phase Ib: a safety run-in period with 3 ascending doses of E7050 in combination with fixed doses of Cisplatin and Capecitabine. This phase will enroll approximately 10 to 15 patients.

* Phase II: a randomized 2-arm design which will enroll 80 patients.

In the phase II portion, Patients will receive study treatment , E7050 in combination with Cisplatin and Capecitabine versus Cisplatin and Capecitabine Alone) for approximately six 21-day cycles (18 weeks). Beyond 18 weeks, patients who are experiencing clinical benefit may continue E7050, with or without Capecitabine (Arm 1), or may continue Capecitabine alone (Arm 2), depending on the original randomization treatment arm. Patients will continue treatment for as long as clinical benefit is sustained and the treatment is well tolerated, until the occurrence of progressive disease (PD), unacceptable toxicity, withdrawal of consent, or withdrawal by investigator, whichever occurs first. Patients will participate in either phase Ib or phase II.

Arms: arm 1: Phase Ib: Cohort 1; 200 mg E7050 + 80 mg/m2 cisplatin + 1000 mg/m2 capecitabine

Cohort 2; 300 mg E7050 + 80 mg/m2 cisplatin + 2000 mg/m2 capecitabine Cohort 3; 400 mg E7050 + 80 mg/m2 cisplatin + 2000 mg/m2 capecitabine arm 2: Phase II: Arm 1; MTD E7050 + 80 mg/m2 cisplatin + 2000 mg/m2 capecitabine
Interventions: intervention 1: E7050 intervention 2: cisplatin intervention 3: capecitabine
Intervention descriptions: intervention 1: E7050 given orally at either 200, 300, or 400 mg once daily. intervention 2: Cisplatin will be administered at 80 mg/m2 by intravenous infusion over 60 minutes on Day 1 of each 21-day treatment cycle. intervention 3: Capecitabine will be administered at 1000 mg/m2 orally, twice daily (2000 mg/m2 total daily dose) on Days 1 through 14 of each 21-day treatment cycle.

Protocol documents:
Clinical trial NCT01370356
Conditions: Smoking Cessation
Keywords: smoking reduction smoking cessation
Sponsor: Pfizer
Start date: 2011-07-01; Completion date: 2013-07-01
Enrollment: 1510 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will determine whether varenicline is safe and helps people to quit smoking through reduction when they are not willing/able to make an abrupt quit attempt.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Varenicline Tartrate intervention 2: Placebo
Intervention descriptions: intervention 1: Varenicline Tartrate oral tablets 2 (0.5mg) tablets twice a day for 24 weeks (first week titration) intervention 2: Matching placebo 2 oral tablets twice a day for 24 weeks (first week titration)

Protocol documents:
Clinical trial NCT01397591
Conditions: Recurrent Adult Diffuse Large Cell Lymphoma Recurrent Grade 1 Follicular Lymphoma Recurrent Grade 2 Follicular Lymphoma Recurrent Grade 3 Follicular Lymphoma Recurrent Mantle Cell Lymphoma
Sponsor: OHSU Knight Cancer Institute
Start date: 2011-10-01; Completion date: 2013-07-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This phase II trial studies how well giving ofatumumab together with bortezomib works in treating patients with relapsed diffuse large B cell lymphoma (DLBCL), follicular lymphoma (FL), or mantle cell lymphoma (MCL). Monoclonal antibodies, such as ofatumumab, can block cancer growth in different ways. Some block the ability of cancer cells to grow and spread. Others find cancer cells and help kill them or carry cancer-killing substances to them. Bortezomib may stop the growth of cancer cells by blocking some of the enzymes needed for cell growth. Giving ofatumumab together with bortezomib may help kill more cancer cells

Detailed description:
PRIMARY OBJECTIVES:

I. To determine the efficacy, as measured by overall response (complete response (CR) + partial response (PR)) of ofatumumab in combination with bortezomib in subjects with relapsed cluster of differentiation (CD)20+ DLBCL, FL or MCL.

SECONDARY OBJECTIVES:

I. To explore duration of efficacy of ofatumumab in combination with bortezomib in the same population as measured by progression free survival (PFS), overall survival (OS) and disease free survival (DFS).

II. To assess response as compared to prior treatment. III. To assess the safety and tolerability of ofatumumab in combination with bortezomib in the same patient population.

TERTIARY OBJECTIVES:

I. Correlation of trough ofatumumab blood levels to response. II. Correlation fragment crystallizable receptor (FcR) gamma 3 allotype and response.

OUTLINE:

Patients receive ofatumumab intravenously (IV) over 2.5 hours on days 1 and 8 of course 1, and day 1 of all subsequent courses. Patients also receive bortezomib IV over 3-5 seconds on days 1, 8, and 15. Treatment repeats every 28 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 3 months for 2 years.

Arms: arm 1: Ofatumumab was given intravenously on cycle 1 day 1 at a dose of 300mg, followed by a cycle 1 day 8 dose of 1000mg. During cycles 2 through cycle 6, Ofatumumab was given at a dose of 1000mg on day 1 of each cycle, with no dosing on any other day of the cycle. Bortezomib was given intravenously at a dose of 1.6mg/m2 on days 1, 8, and 15 of each cycle, following the Ofatumumab infusion, if given.
Interventions: intervention 1: Ofatumumab intervention 2: Bortezomib
Intervention descriptions: intervention 1: Given intravenously intervention 2: Given intravenously

Protocol documents:
Clinical trial NCT01401023
Conditions: Diarrhea Clostridium Difficile
Sponsor: Gary E. Stein, Pharm.D.
Start date: 2011-07-01; Completion date: 2013-07-01
Enrollment: 10 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a prospective, non-comparative, interventional, observational pilot study of the safety and pharmacokinetics of intravenous (IV) tigecycline in conjunction with standard oral therapy in patients with known mild to severe confirmed Clostridium difficile associated diarrhea (CDAD).

Detailed description:
The intervention is adding Tigecycline (standard doses) to standard oral therapy for CDAD. Patients will then be observed for clinical outcomes and relapse of CDAD.

Arms: arm 1: Open non-comparative trial
Interventions: intervention 1: Tigecycline
Intervention descriptions: intervention 1: : Standard treatment doses of oral antibiotics (vancomycin or metronidazole) for CDAD along with IV tigecycline (100 milligram loading dose followed by 50 milligrams every 12 hours) will be given to patients during their hospitalization (usually 7-14 days). Patients well enough to go home will receive only oral therapy.

Protocol documents: