ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01702519
Conditions: Smoking
Sponsor: GlaxoSmithKline
Start date: 2012-03-01; Completion date: 2012-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Bioequivalence study to confirm that a NTS with a polyisobutylene (PIB) adhesive from an alternative supplier delivers the same nicotine blood profile as that of the currently approved NTS with a polyisobutylene adhesive from the current supplier.

Detailed description:

Arms: arm 1: nicotine transdermal patch with the existing polyisobutylene adhesive arm 2: nicotine transdermal patch with the alternate polyisobutylene adhesive
Interventions: intervention 1: nicotine
Intervention descriptions: intervention 1: nicotine transdermal patch

Protocol documents:
Clinical trial NCT01790490
Conditions: Cocaine Dependence
Sponsor: New York State Psychiatric Institute
Start date: 2011-02-01; Completion date: 2012-03-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Cocaine dependence involves problematic neuroadaptations, such as heightened reactivity to cocaine cues, that may be responsive to pharmacological modulation of glutamatergic circuits. Despite promising preclinical findings with n-methyl-d-aspartate receptor (NMDAr) modulators, studies with human subjects have been unsuccessful to date. The purpose of this investigation is to examine the effects of the NMDAr antagonist ketamine, recently found to have potent therapeutic effects in humans, on cue-induced craving and impaired motivation for quitting cocaine in cocaine dependent participants, 24-hours post-infusion.

Detailed description:
In this study, volunteers will undergo a 9 day inpatient trial during which they will receive three counter-balanced infusions (two doses of ketamine and a dose of lorazepam) on three separate days in a within-subject, double-blind, controlled design. Of the various glutamate antagonists available for human use, ketamine will be utilized because its safety profile, pharmacokinetics, and range of tolerable sub-anesthetic dosings have been very well studied. Also, ketamine has shown promise in managing opiate and alcohol use disorders in certain studies, and may therefore be the most likely glutamate antagonist to dampen cue reactivity and increase motivation in cocaine users. If ketamine significantly improves these deficits, this would suggest that the drug should be investigated further for potential utility as a treatment for cocaine dependence.

Arms: arm 1: Ketamine 0.41 mg/kg infused over 52 min (K1) arm 2: Ketamine 0.71 mg/kg infused over 52 min (K2) arm 3: Lorazepam 2 mg infused over 52 minutes (LZP)
Interventions: intervention 1: Ketamine 0.41 mg/kg intervention 2: Ketamine 0.71 mg/kg intervention 3: Lorazepam 2 mg
Intervention descriptions: intervention 1: 52 minute iv infusion of ketamine 0.41 mg/kg intervention 2: 52 minute iv infusion of ketamine 0.71 mg/kg. This dose follows K1 in all 3 orderings. intervention 3: 52 minute infusion of lorazepam 2 mg. This serves as an active control.

Protocol documents:
Clinical trial NCT02185729
Conditions: Diseases, Metabolic Insulin Sensitivity
Keywords: Intravenous Feeding Lipid Emulsions, Intravenous
Sponsor: Emory University
Start date: 2008-06-01; Completion date: 2012-03-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Many patients in the hospital who are malnourished or not eating received intravenous feeding or total parenteral nutrition (TPN). Despite improving nutrition, TPN may increase the risk of infections and hospital complications. We do not know why TPN increases hospital complications, but it may be caused by the high sugar or fat content in TPN solutions. The investigators believe that the high sugar and high fat content can limit the ability to fight infections and produce stiffness of blood vessels. This study will compare the effect of high sugar, high fat content or both on blood sugars, blood vessel function, on blood vessel function. The investigators will also compare the effect of different fats (olive oil and soybean) in the TPN solution on the risk of infection and blood vessel function on a total of 12 healthy subjects.

Detailed description:

Arms: arm 1: Subjects receive 24 hours of infusion of 0.9% normal saline, dextrose (sugar) without fat, ClinOleic (olive oil-based), and Intralipid (soybean-derived fat)
Interventions: intervention 1: Intralipid intervention 2: ClinOleic intervention 3: Dextrose intervention 4: Saline (control)
Intervention descriptions: intervention 1: Infusion of Intralipid (soybean-derived fat) intervention 2: Infusion of ClinOleic (olive oil-based) intervention 3: Infusion of dextrose (sugar) without fat intervention 4: Infusion of 0.9% normal saline

Protocol documents:
Clinical trial NCT01375777
Conditions: Hyperlipidemia
Keywords: High cholesterol Proprotein convertase subtilisin/kexin type 9 (PCSK9) Treatment for high cholesterol Lowering cholesterol Lowering high cholesterol Hypercholesterolemia
Sponsor: Amgen
Start date: 2011-07-06; Completion date: 2012-03-02
Enrollment: 411 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective was to evaluate the effect of 12 weeks of subcutaneous evolocumab (AMG 145) every 2 weeks (Q2W) or every 4 weeks (Q4W), compared with placebo, on the percent change from baseline in LDL-C when used as monotherapy in adults with hypercholesterolemia.

Detailed description:

Arms: arm 1: Participants received placebo subcutaneous injection once every 2 weeks (Q2W) for 12 weeks. arm 2: Participants received placebo subcutaneous injection once every 4 weeks (Q4W) for 12 weeks. arm 3: Participants received 10 mg ezetimibe orally once a day for 12 weeks. arm 4: Participants received 70 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. arm 5: Participants received 105 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. arm 6: Participants received 140 mg evolocumab by subcutaneous injection once every 2 weeks for 12 weeks. arm 7: Participants received 280 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. arm 8: Participants received 350 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks. arm 9: Participants received 420 mg evolocumab by subcutaneous injection once every 4 weeks for 12 weeks.
Interventions: intervention 1: Evolocumab intervention 2: Ezetimibe intervention 3: Placebo to Evolocumab
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Administered orally once a day intervention 3: Administered by subcutaneous injection

Protocol documents:
Clinical trial NCT01446003
Conditions: Hypertension
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-10-25; Completion date: 2012-03-03
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate the effect of treatment with multiple doses of MK-8457 on systolic blood pressure in participants with mild to moderate hypertension in addition to safety and tolerability. The study hypothesis is that MK-8457 does not increase systolic blood pressure to a clinically significant extent, as measured by 24-hour mean ambulatory systolic blood pressure change from baseline after 10 days of dosing.

Detailed description:

Arms: arm 1: Participants received MK-8457 100 mg twice daily (BID) for 10 days followed by Placebo for 10 days. Each treatment was separated by a 10-day washout. arm 2: Participants received Placebo for 10 days followed by MK-8457 100 mg BID for 10 days. Each treatment was separated by a 10-day washout.
Interventions: intervention 1: MK-8457 intervention 2: Placebo for MK-8457
Intervention descriptions: intervention 1: 10 x 10-mg capsule BID for 10 days intervention 2: 10 x 10-mg capsule BID for 10 days

Protocol documents:
Clinical trial NCT00545740
Conditions: Diverticulitis
Sponsor: Shire
Start date: 2007-11-28; Completion date: 2012-03-05
Enrollment: 590 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether SPD476 is effective in reducing recurrence of diverticulitis.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: SPD476 (1.2g) intervention 2: SPD476 (2.4 g) intervention 3: SPD476 (4.8 g) intervention 4: Placebo
Intervention descriptions: intervention 1: 1.2g SPD476 once daily (QD) orally intervention 2: 2.4g SPD476 QD orally intervention 3: 4.8g SPD476 QD orally intervention 4: QD orally

Protocol documents:
Clinical trial NCT00919711
Conditions: Osteoporosis
Keywords: Menopausal Osteoporosis
Sponsor: Amgen
Start date: 2009-09-01; Completion date: 2012-03-05
Enrollment: 870 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, open label study to assess the safety and effectiveness of Denosumab, administered every 6 months and Actonel ® (Risedronate), administered monthly in post menopausal women transitioned from weekly or daily Alendronate therapy.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Actonel® intervention 2: Denosumab
Intervention descriptions: intervention 1: Oral Actonel® (Risedronate) in total a 150mg per month (one 75mg tablet to be taken on each of 2 consecutive days per month). intervention 2: Denosumab 60 mg, once every 6 months, Subcutaneous

Protocol documents:
Clinical trial NCT01275170
Conditions: Infectious Disease
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-01-28; Completion date: 2012-03-05
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2-part study of the pharmacokinetics (PK) of MK-7655. In Part I, the PK of a single 125 mg dose of MK-7655 given in combination with 250 mg of PRIMAXIN® (imipenem + cilastatin) will be determined in participants with impaired renal function and matched control participants. In Part II, the potential for renal insufficiency to affect non-renal clearance mechanisms will be investigated.

Detailed description:

Arms: arm 1: Participants with an eGFR of \>50 to \<80 mL/min/1.73 m\^2 receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. arm 2: A subset of healthy control participants were matched specifically to participants in Panel A and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. arm 3: Participants with an eGFR of 30 to 50 mL/min/1.73 m\^2 receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. arm 4: A subset of healthy control participants were matched specifically to participants in Panel C and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. arm 5: Participants with an eGFR \<30 mL/min/1.73 m\^2 receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg. arm 6: A subset of healthy control participants were matched specifically to participants in Panel E and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg. arm 7: Participants with ESRD/HD receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV postdialysis (Part 1, Period 1) and predialysis (Part 1, Period 2). In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg predialysis (Part 2, Period 1) and postdialysis (Part 2, Period 2). arm 8: A subset of healthy control participants were matched specifically to participants in Panel G and receive a single dose of MK-7655 125 mg + PRIMAXIN® 250 mg IV in Part 1. In Part 2, participants receive an oral cocktail containing caffeine 200 mg, midazolam 2 mg, and omeprazole 40 mg.
Interventions: intervention 1: MK-7655 intervention 2: Imipenem + Cilastatin intervention 3: Caffeine intervention 4: Midazolam intervention 5: Omeprazole
Intervention descriptions: intervention 1: 125 mg intravenous (IV) over 30 minutes as a single dose intervention 2: 250 mg IV over 30 minutes as a single dose intervention 3: Caffeine caplet, single 200 mg dose, orally intervention 4: Midazolam hcl syrup single 2.0 mg dose by mouth. intervention 5: Omeprazole tablets, single 40 mg dose (as two 20 mg tablets), orally

Protocol documents:
Clinical trial NCT01381562
Conditions: Infections, Intestinal
Keywords: intra-abdominal infection belly Gram-negative pathogen abscess peritonitis
Sponsor: GlaxoSmithKline
Start date: 2011-10-03; Completion date: 2012-03-05
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the safety, efficacy and pharmacokinetics/pharmacodynamics of GSK2251052 in subjects with complicated intra abdominal infections. GSK2251052 will be compared to meropenem, an IV therapy that is approved for use in the treatment of subjects with cIAI. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cIAI.

Detailed description:

Arms: arm 1: q12h administered via IV infusion, plus saline placebo arm 2: q12h administered via IV infusion, plus saline placebo arm 3: q8h administered via IV infusion, plus saline placebo
Interventions: intervention 1: Drug: GSK2251052 intervention 2: Meropenem intervention 3: Placebo
Intervention descriptions: intervention 1: Reconstituted, added to 250mL 0.9% NaCl solution and administered via IV infusion intervention 2: Reconstituted, added to 100mL 0.9% NaCl solution and administered via IV infusion intervention 3: saline placebo

Protocol documents:
Clinical trial NCT00910962
Conditions: Acute Coronary Syndrome
Keywords: NSTEMI, acute coronary syndrome, p38 MAPK inhibitor, GW856553, percutaneous coronary intervention
Sponsor: GlaxoSmithKline
Start date: 2009-10-08; Completion date: 2012-03-06
Enrollment: 526 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, double-blind, placebo-controlled, parallel group, multi-center study to evaluate initial safety and efficacy of GW856553 in subjects with NSTEMI. Up to approximately 525 subjects will be randomized to meet the MRI recruitment target (90 subjects in substudy.) All subjects will continue to receive the local standard of care for the duration of the study.

Detailed description:

Arms: arm 1: 7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks arm 2: 15 mg GW856553 starting dose, followed 12 hours later by 7.5mg twice daily for 12 weeks arm 3: Placebo twice daily for 12 weeks
Interventions: intervention 1: GW856553 intervention 2: GW856553 intervention 3: Placebo
Intervention descriptions: intervention 1: 7.5 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID intervention 2: 15 mg GW856553 starting dose, followed 12 hours later by 7.5mg BID intervention 3: Placebo

Protocol documents:
Clinical trial NCT01381549
Conditions: Infections, Urinary Tract
Keywords: Gram-negative uropathogens complicated lower urinary tract infection pyelonephritis
Sponsor: GlaxoSmithKline
Start date: 2011-06-28; Completion date: 2012-03-06
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to evaluate the safety, efficacy (clinical and microbiological), pharmacokinetics/pharmacodynamics of GSK2251052 and to assess whether it would be a suitable antibiotic for the treatment for febrile lower cUTI and pyelonephritis(complicated and uncomplicated). GSK2251052 will be compared to imipenem-cilastatin, which is an antibiotic commonly used to treat serious cUTI infections. GSK2251052 has a spectrum of microbiological activity that includes pathogens responsible for cUTI.

Detailed description:

Arms: arm 1: q12h administered via IV infusion, plus saline placebo arm 2: q12h administered via IV infusion, plus saline placebo arm 3: 500 mg imipenem monohydrate and 500 mg cilastatin sodium; q6h administered via IV infusion, plus saline placebo
Interventions: intervention 1: GSK2251052 intervention 2: imipenem-cilastatin intervention 3: Placebo
Intervention descriptions: intervention 1: Reconstituted, added to 250mL 0.9% NaCl solution and administered via IV infusion intervention 2: Prepare as per prescribing information instructions in 100 mL bag of 0.9% NaCl and administered via IV infusion intervention 3: saline placebo

Protocol documents:
Clinical trial NCT01253564
Conditions: Malignant Melanoma
Sponsor: Hoffmann-La Roche
Start date: 2010-11-22; Completion date: 2012-03-14
Enrollment: 24 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This open-label study will assess the safety and efficacy of RO5185426 in previously treated metastatic melanoma patients with brain metastases. Patients will receive RO5185426 at a dose of 960 mg twice daily orally until disease progression or unacceptable toxicity occurs.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: RO5185426
Intervention descriptions: intervention 1: 960 mg b.i.d. orally

Protocol documents:
Clinical trial NCT01069705
Conditions: Pulmonary Infections Pseudomonas Aeruginosa
Keywords: Tobramycin Inhalation Powder Cystic fibrosis Lung diseases Anti-Bacterial Agents Treatment of pulmonary infections with P. aeruginosa in cystic fibrosis participants
Sponsor: Novartis Pharmaceuticals
Start date: 2010-02-12; Completion date: 2012-03-19
Enrollment: 49 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.

Detailed description:

Arms: arm 1: Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.
Interventions: intervention 1: Tobramycin inhalation powder
Intervention descriptions: intervention 1: Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.

Protocol documents:
Clinical trial NCT01116440
Conditions: Pelvic Pain Associated With Refractory Endometriosis
Keywords: Menstrual pain Refractory endometriosis Pelvic pain
Sponsor: Mereo BioPharma
Start date: 2010-04-15; Completion date: 2012-03-21
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine efficacy, safety, tolerability and pharmacokinetics of multiple doses of BGS649 with concurrent daily administration of combined oral contraception in patients with refractory endometriosis

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: BGS649 intervention 2: Placebo
Intervention descriptions: intervention 1: 0.1 mg capsules for oral administration. A total dose of 3 capsules of BGS649 0.1mg will be administered at randomization, week 4, and week 8 at the study site. intervention 2: Placebo matching BGS649 will be provided by Novartis as capsules for oral administration. Three capsules of placebo will be administered at randomization, week 4, and week 8 at the study site.

Protocol documents:
Clinical trial NCT01000506
Conditions: Asthma
Keywords: Dose-ranging Safety Pharmacodynamics eosinophils SB-240563 Efficacy Severe refractory asthma mepolizumab Placebo
Sponsor: GlaxoSmithKline
Start date: 2009-11-01; Completion date: 2012-03-23
Enrollment: 621 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to show whether mepolizumab given every 4 weeks intravenously (i.v.) can reduce the frequency of asthma exacerbations in subjects with severe asthma despite receiving high doses of standard asthma medications. The study will look at different doses of mepolizumab in comparison to a placebo.

Detailed description:
A double-blind, placebo-controlled study to evaluate the efficacy, safety and pharmacodynamics of three doses (75 mg, 250 mg and 750 mg) of mepolizumab intravenous (i.v.) administered every 4 weeks compared with placebo over a 52-week treatment period in subjects with severe uncontrolled refractory asthma. Efficacy will be measured by the frequency of asthma exacerbations. In addition lung function, rescue medication usage, daily symptoms, asthma control score, asthma quality of life score and withdrawals due to asthma exacerbations will be assessed. Safety will be assessed by adverse events, clinical laboratory evaluations, ECGs, immunogenicity and vital signs. Pharmacodynamics will be assessed by eosinophil levels in blood, serum IL-5 and eosinophil levels in induced sputum.

Arms: arm 1: Mepolizumab 750mcg i.v. every 4 weeks arm 2: Mepolizumab 250mcg i.v. every 4 weeks arm 3: Mepolizumab 75mcg i.v. every 4 weeks arm 4: Placebo saline every 4 weeks i.v.
Interventions: intervention 1: Mepolizumab 750 intervention 2: Mepolizumab 250 intervention 3: Mepolizumab 75 intervention 4: Placebo saline
Intervention descriptions: intervention 1: Mepolizumab 750mg every four weeks by i.v. intervention 2: Mepolizumab 250mg every four weeks by i.v. intervention 3: Mepolizumab 75mg every four weeks by i.v. intervention 4: Placebo saline every four weeks by i.v.

Protocol documents:
Clinical trial NCT01407276
Conditions: Chronic Renal Insufficiency Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2011-08-08; Completion date: 2012-03-23
Enrollment: 49 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 2-part study in participants with renal impairment and matched healthy participants to investigate the effect of impaired renal function on the plasma and urine levels of omarigliptin (MK-3102) after taking a single 3 mg dose by mouth.

Detailed description:
In Part I, three panels of 6 participants each will be enrolled with varying degrees of renal disease (mild, moderate, or severe renal impairment) based on their estimated glomerular filtration rate (eGFR). Each of these panels will be matched with a corresponding panel of equal number of healthy, age-, race-, BMI- and gender-matched control participants. All panels will receive a single oral dose of 3-mg omarigliptin, followed by plasma sampling and urine collection. In Part II, 6 participants with end stage renal disease (ESRD) requiring hemodialysis will receive a single 3-mg oral dose of omarigliptin immediately following hemodialysis (HD) (Period 1) and 2 hours prior to HD (Period 2).There will be approximately 1 month between Period 1 and Period 2. A corresponding panel of equal number, healthy matched control subjects (age, race, BMI, gender) will also receive a single 3 mg dose by mouth. Omarigliptin dose administration will be followed by plasma sampling for both panels.

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None arm 6: None arm 7: None arm 8: None
Interventions: intervention 1: Omarigliptin
Intervention descriptions: intervention 1: Single oral dose of 3 mg (3 x 1-mg capsules)

Protocol documents: