ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00443209
Conditions: Migraine
Sponsor: Merck Sharp & Dohme LLC
Start date: 2007-02-21; Completion date: 2009-01-22
Enrollment: 1068 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to investigate the safety and tolerability of telcagepant (MK-0974) in the long-term treatment of acute migraine in adult participants. The primary hypothesis of this study is that telcagepant is well tolerated in the long-term treatment of acute migraine in adult participants.

Detailed description:

Arms: arm 1: Participants receive telcagepant 300 mg soft gel capsules or telcagepant 280 mg tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of telcagepant, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of telcagepant per month for up to 18 months. arm 2: Participants receive rizatriptan tablets, administered orally as a single dose at onset of migraine. If still experiencing a migraine 2 hours after the first dose of rizatriptan, participants may take an optional second dose of study drug or non-study rescue medication. Participants may take up to 16 doses (for treatment of up to 8 migraines) of rizatriptan per month for up to 18 months.
Interventions: intervention 1: Telcagepant 300 mg soft gel capsules intervention 2: Telcagepant 280 mg tablets intervention 3: Rizatriptan 10 mg tablets intervention 4: Placebo to telcagepant capsules intervention 5: Placebo to telcagepant tablets intervention 6: Placebo to rizatriptan tablets
Intervention descriptions: intervention 1: One capsule taken orally at onset of migraine intervention 2: One tablet taken orally at onset of migraine intervention 3: One tablet taken orally at onset of migraine intervention 4: One capsule taken orally at onset of migraine intervention 5: One tablet taken orally at onset of migraine intervention 6: One tablet taken orally at onset of migraine

Protocol documents:
Clinical trial NCT00348309
Conditions: Alzheimer's Disease
Keywords: apolipoprotein E Alzheimer's disease cognition rosiglitazone adjunctive therapy
Sponsor: GlaxoSmithKline
Start date: 2006-07-06; Completion date: 2009-01-28
Enrollment: 1496 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Rosiglitazone (RSG) has been tested in clinical studies and is approved by the FDA as a treatment for type II diabetes mellitus, a disease that occurs when the body is unable to effectively use glucose. RSG XR, the investigational drug used in this study, is an extended-release form of RSG.

This study tests whether RSG XR safely provides clinical benefit to people with mild to moderate Alzheimer's disease (AD) when combined with the currently approved AD medication, Aricept (donepezil). RSG XR is a new approach to AD therapy and this study tests a new way to treat AD by testing whether one's genetic makeup affects their response to the study drug. Clinical data suggesting that RSG may benefit AD patients was first seen in a small study performed at the University of Washington and then from a larger GSK study conducted in Europe and New Zealand. In the first study, subjects receiving RSG once daily for 6 months scored significantly better on 3 tests of memory and thought than those who did not receive RSG. In the GSK study, those that appeared to benefit most from treatment with RSG XR had a specific genetic pattern. They did not have the gene that caused them to produce the protein apolipoprotein E e4 (APOE e4). Subjects who have the APOE e4 gene may have two copies, one from each parent, or they may have only one APOE e4 gene meaning that they inherited either the APOE e2 or APOE e3 version of the gene, instead of APOE e4, from one of their parents. Subjects with one copy of the APOE e4 gene remained at their same level of thinking ability while those with two copies of the APOE e4 gene, continued to worsen during the 6-month treatment. The current study will more directly test the effectiveness or RSG XR on people who either have or lack the APOE e4 gene.

Detailed description:
A 54-week, double-blind, randomized, placebo-controlled, parallel-group study to investigate the effects of rosiglitazone (extended release tablets) as adjunctive therapy to donepezil on cognition and overall clinical response in APOE e4-stratified subjects with mild to moderate Alzheimer's disease (REFLECT-2)

Arms: arm 1: Rosiglitazone Extended Release 2mg OD arm 2: Rosiglitazone Extended Release 8mg OD arm 3: Placebo
Interventions: intervention 1: Rosiglitazone Extended Release 2mg intervention 2: Rosiglitazone Extended Release 8mg intervention 3: Placebo intervention 4: Donepezil
Intervention descriptions: intervention 1: Rosiglitazone Extended Release 2mg OD intervention 2: Rosiglitazone Extended Release 8mg OD intervention 3: Placebo intervention 4: Donepezil (At least 6 months of ongoing donepezil therapy for Alzheimer's disease, with stable dosing for at least the last 2 months (and with no intent to change for the duration of the study).

Protocol documents:
Clinical trial NCT00028002
Conditions: Gastrointestinal Stromal Tumor
Sponsor: National Cancer Institute (NCI)
Start date: 2002-03-31; Completion date: 2009-01-28
Enrollment: 63 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Phase II trial to study the effectiveness of neoadjuvant and adjuvant imatinib mesylate in treating patients who are undergoing surgery for primary or recurrent malignant gastrointestinal stromal tumor. Imatinib mesylate may stop the growth of tumor cells by blocking the enzymes necessary for their growth. Giving imatinib mesylate before and after surgery may shrink the tumor so it can be removed and may kill any tumor cells remaining after surgery.

Detailed description:
OBJECTIVES:

I. Determine the progression-free survival of patients with primary or recurrent potentially resectable malignant gastrointestinal stromal tumor treated with neoadjuvant and adjuvant imatinib mesylate.

II. Determine the objective response rate of patients treated with this drug. III. Determine the safety of this drug in these patients.

OUTLINE:

Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.

Patients are followed every 3 months for 2 years and then every 6 months for 3 years.

Arms: arm 1: Patients receive oral imatinib mesylate once daily. Treatment continues for 8 weeks in the absence of disease progression. Patients with disease progression are considered for immediate surgical resection. Otherwise, after 8 weeks, patients undergo surgical resection to debulk all gross tumor. Two to four weeks after surgery, patients receive oral imatinib mesylate once daily for 2 years.
Interventions: intervention 1: Conventional Surgery intervention 2: Imatinib Mesylate
Intervention descriptions: intervention 1: Undergo surgical resection intervention 2: Given orally

Protocol documents:
Clinical trial NCT00915343
Conditions: Adrenal Insufficiency
Keywords: Adrenal insufficiency Primary adrenal insufficiency Addison's disease Hydrocortisone Modified release
Sponsor: Shire
Start date: 2007-08-21; Completion date: 2009-01-28
Enrollment: 64 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a randomised, controlled, open, two-armed, two-period cross-over, multi-centre phase II/III study to assess the safety, tolerability and pharmacokinetics of once-daily oral modified-release hydrocortisone in comparison to conventional thrice-daily oral hydrocortisone tablets in patients with adrenal insufficiency

Detailed description:
Adrenal insufficiency is a disease with more than 80% 1-year mortality before the availability of synthetic glucocorticoids. Current replacement therapy has improved this dramatically, but recent data suggest that outcome is still compromised. Patient receiving replacement therapy with hydrocortisone or cortisone acetate have compromised quality of life, reduced bone mass, increased risk factors for cardiovascular disease and premature mortality that is more than twice the mortality rate in the background population.

Circulating cortisol levels follow a distinct diurnal pattern with high levels in the early morning and low trough values around midnight. Using available formulations for replacement therapy this circadian rhythm is had to mimic and also during the active time of the day high peaks and low troughs occur.

In this trial a newly developed novel dual-, controlled release formulation of hydrocortisone that has in healthy volunteers been able to mimic the circadian pattern of circulating cortisol was studied in patients with primary adrenal insufficiency (Addison's disease).

Arms: arm 1: Test drug: hydrocortisone (modified release), oral tablet, available as 20 mg and 5 mg.

The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state arm 2: Reference drug: hydrocortisone, oral tablet, 10 mg. The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM)in the same total daily dose as the experimental drug. The morning dose was administered in the fasting state.
Interventions: intervention 1: hydrocortisone (modified release), oral tablet 20 and 5 mg intervention 2: Hydrocortisone, oral tablet, 10 mg
Intervention descriptions: intervention 1: The modified release hydrocortisone tablet was administered orally o.d. at 8 AM in the fasting state. The dose was the same as patients have had before entering the trial intervention 2: The reference drug was administered orally thrice daily (at 8 AM, 12 AM and 4 PM). The morning dose was administered in the fasting state. The total daily dose was the same as in the experimental treatment arm.

Protocol documents:
Clinical trial NCT00626886
Conditions: Postoperative Pain Inguinal Hernia
Keywords: Herniorrhaphy Inguinal Hernia Repair Postoperative pain
Sponsor: Innocoll
Start date: 2008-03-11; Completion date: 2009-01-29
Enrollment: 53 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether the CollaRx Bupivacaine implant is safe and effective in reducing the amount of narcotic pain medication needed to control pain during the first 24 hours after herniorrhaphy.

Detailed description:
Inguinal herniorrhaphy is a common surgery; and common surgical methods used include laparoscopic and open placement of synthetic mesh. The use of synthetic mesh can greatly reduce the risk of hernia recurrence regardless of the method used for its placement. Managing postoperative pain and preventing morbidity after open mesh herniorrhaphy remain considerable medical challenges.

Bupivacaine is a local anesthetic (pain medicine) that has an established safety profile. Collagen is a protein that is found in all mammals. The CollaRx Bupivacaine implant is a thin flat sponge made out of collagen that comes from cow tendons and contains bupivacaine. When inserted into a surgical site, the collagen breaks down and bupivacaine is released at the site but very little is absorbed into the blood stream. The high levels of bupivacaine at the surgical site may result in less pain for several days after surgery.

This study will compare the amount of narcotic pain medication required after surgery in patients who receive either the CollaRx Bupivacaine implant or a plain collagen sponge.

Arms: arm 1: Two, 5x5cm bupivacaine collagen sponges implanted during surgery arm 2: Placebo collagen sponge implanted during surgery
Interventions: intervention 1: Bupivacaine Collagen Sponge intervention 2: placebo collagen sponge
Intervention descriptions: intervention 1: collagen; Bupivacaine hydrocholoride intervention 2: collagen

Protocol documents:
Clinical trial NCT00642993
Conditions: Obesity Overweight Body Weight
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-06-09; Completion date: 2009-01-30
Enrollment: 401 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the effect of SCH 497079 on weight in obese and overweight participants. The primary measure of effectiveness is the change in body weight during treatment. Additional measures include waist circumference and body mass index (BMI). In addition, the safety of SCH 497079 in obese and overweight participants will be evaluated. The primary hypothesis is that treatment with SCH 497079 will be more efficacious than that with placebo with respect to the primary efficacy variable.

Detailed description:
Following Screening, eligible participants will enroll in a Run-in Period. Participants who qualify for continuation in the study according to the entry criteria will be randomized to one of two treatment groups (SCH 497079 or placebo in a 2:1 ratio) with stratification according to gender.

Baseline measurements for the primary efficacy endpoint, as well as secondary endpoints will be evaluated at the Randomization Visit (Visit 3). Following randomization, participants will be treated for 12 weeks with double-blind study drug as adjunct to a 500 kcal deficit diet.

Participants will have scheduled visits after the Randomization Visit at 2 to 4 week intervals. Each participant will be encouraged to adhere to medication and dietary instructions.

Arms: arm 1: SCH 497079, administered orally, once daily arm 2: Placebo capsules, administered orally, once daily
Interventions: intervention 1: SCH 497079 intervention 2: Placebo
Intervention descriptions: intervention 1: 100 mg capsule administered orally intervention 2: Placebo capsules matching SCH 497079 administered orally

Protocol documents:
Clinical trial NCT00356187
Conditions: Trauma
Sponsor: Denver Health and Hospital Authority
Start date: 2006-02-15; Completion date: 2009-01-31
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Critically injured patients endure a period of hypermetabolism/catabolism after being resuscitated. The metabolic cost of this may be measured in loss of lean body mass, poor wound healing, susceptibility to infection and long hospital stays. While there have been some data to suggest that hypermetabolism can be ameliorated in burn patients by beta blockade, to our knowledge, a prospective trial in trauma patients has not yet been done. Our hypothesis is that nonselective beta blockade will reduce catabolism, improve glucose control, blunt loss of lean body mass, decrease infections and improve outcome in a cohort of critically injured patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Propranolol
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00395135
Conditions: Obesity
Keywords: Obesity Weight loss lorcaserin APD356 BLOOM Hypertension Dyslipidemia Sleep apnea glucose tolerance cardiovascular disease Arena
Sponsor: Eisai Inc.
Start date: 2006-11-01; Completion date: 2009-02-01
Enrollment: 3182 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the weight loss effect of lorcaserin at the end of the first year of treatment (Week 52) and to assess the ability of lorcaserin to maintain weight loss at the end of the second year of treatment (Week 104)

Detailed description:

Arms: arm 1: Lorcaserin 10 mg tablet each morning and evening arm 2: Matching placebo tablet each morning and evening
Interventions: intervention 1: Lorcaserin 10 mg BID intervention 2: Matching Placebo BID
Intervention descriptions: intervention 1: Lorcaserin 10 mg tablet each morning and evening for a duration of 52 or 104 weeks. intervention 2: Matching placebo tablet each morning and evening for a duration of 52 or 104 weeks.

Protocol documents:
Clinical trial NCT00445679
Conditions: Depressive Disorder, Major
Keywords: major depressive disorder MDD depression
Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer
Start date: 2007-07-01; Completion date: 2009-02-01
Enrollment: 807 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will assess the safety, tolerability and efficacy of desvenlafaxine succinate sustained release (DVS SR) in subjects with major depressive disorder.

Detailed description:
The primary objective of this study is to investigate the efficacy, safety and tolerability of desvenlafaxine succinate sustained release (DVS SR) in Chinese, Taiwanese, South Korean, and Indian subjects with major depressive disorder (MDD) receiving daily doses of 50 mg, 100 mg, or 200 mg. The secondary objective is to obtain additional information regarding the efficacy of DVS SR in subjects with MDD receiving daily doses of 50 mg, 100 mg, or 200 mg. Additional objectives include obtaining general and functional quality of life outcome data.

Arms: arm 1: DVS SR 50mg/day arm 2: DVS SR 100mg/day arm 3: DVS SR 200mg/day arm 4: Paroxetine 20mg/day
Interventions: intervention 1: DVS SR intervention 2: Paroxetine
Intervention descriptions: intervention 1: Arm 1: 50mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 2: 100mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper Arm 3: 200mg DVS SR tablet, QD, 8 weeks treatment with 2 week taper intervention 2: 20 mg Paroxetine capsule, QD, 8 weeks treatment with 2 week taper

Protocol documents:
Clinical trial NCT00620659
Conditions: Sleep Apnea, Obstructive Hypopnea Syndrome Excessive Daytime Sleepiness
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-02-01; Completion date: 2009-02-01
Enrollment: 125 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine the safety and efficacy of MK0249 in treating refractory excessive daytime sleepiness (EDS) in patients with Obstructive Sleep Apnea/Hypopnea Syndrome (OSA/HS) using nasal continuous positive airway pressure (nCPAP) therapy.

Detailed description:

Arms: arm 1: Arm 1: Treatment period 1: MK0249; Treatment period 2: Placebo; Treatment period 3: modafinil arm 2: Arm 2: Treatment period 1: Placebo; Treatment period 2: modafinil; Treatment period 3: MK0249 arm 3: Arm 3: Treatment period 1: modafinil; Treatment period 2: MK0249; Treatment period 3: Placebo arm 4: Arm 4: Treatment period 1: MK0249; Treatment period 2: modafinil; Treatment period 3: Placebo arm 5: Arm 5: Treatment period 1: Placebo; Treatment period 2: MK0249; Treatment period 3: modafinil arm 6: Arm 6: Treatment period 1: modafinil; Treatment period 2: Placebo; Treatment period 3: MK0249
Interventions: intervention 1: Comparator: MK0249 intervention 2: Comparator: placebo intervention 3: Comparator: modafinil
Intervention descriptions: intervention 1: Patients will be assigned to receive MK0249 film coated tablet (FCT). The doses of MK0249 that are included for possible investigation (depending upon an adaptive allocation process) are 3 mg, 5 mg, 8 mg, 10 mg, and 12 mg. Study medication will be taken for 14 days, during each of the 3 treatment periods, by mouth (po) once a day (qd). intervention 2: Placebo; Patients will be assigned to receive placebo, across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd. intervention 3: Patients will be assigned to receive modafinil 200mg oral compressed tablet (OCT), across 3 treatment periods. Study medication will be taken for 14 days, during each of the 3 treatment periods, po qd.

Protocol documents:
Clinical trial NCT00730691
Conditions: Generalized Anxiety Disorder
Keywords: Generalized Anxiety Disorder Mood Disorder Affective Disorder Anxiety Disorder Drug Therapy
Sponsor: Takeda
Start date: 2008-06-01; Completion date: 2009-02-01
Enrollment: 781 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and efficacy of vortioxetine, once daily (QD), in adults with generalized anxiety disorder.

Detailed description:
Participants in this study will be randomly assigned to receive either 2.5 mg, 5 mg or 10 mg of vortioxetine, once daily, 60 mg of duloxetine once daily, or a placebo once daily for eight weeks.

Participants will be seen weekly during the first 2 weeks of treatment, and then every 2 weeks up to the end of the 8-week treatment period. Participants who complete the 8-week treatment period will enter a 2-week discontinuation period in order to assess potential discontinuation symptoms. Total commitment time is up to 12 weeks.

Arms: arm 1: Placebo-matching capsules, orally, once daily for up to 9 weeks. arm 2: Vortioxetine 2.5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. arm 3: Vortioxetine 5 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. arm 4: Vortioxetine 10 mg encapsulated tablets, orally, once daily, for 8 weeks, followed by placebo-matching capsules, orally, once daily, for 1 week. arm 5: Duloxetine 60 mg capsules, orally, once daily, for 8 weeks, followed by duloxetine 30 mg capsules, orally, once daily, for 1 week.
Interventions: intervention 1: Placebo intervention 2: Vortioxetine intervention 3: Duloxetine
Intervention descriptions: intervention 1: Placebo-matching capsules intervention 2: Encapsulated vortioxetine immediate release tablets intervention 3: Overencapsulated duloxetine capsules

Protocol documents:
Clinical trial NCT01014013
Conditions: Urinary Tract Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-04-01; Completion date: 2009-02-01
Enrollment: 271 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the efficacy of ertapenem sodium (Invanz) in treatment of complicated urinary tract infections with respect to the proportion of patients with a favorable microbiological response at 5-9 days post therapy.

Detailed description:

Arms: arm 1: ertapenem sodium arm 2: ceftriaxone sodium
Interventions: intervention 1: ertapenem sodium (MK0826) intervention 2: Comparator: ceftriaxone sodium
Intervention descriptions: intervention 1: a single daily dose of ertapenem sodium 1.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy if needed) intervention 2: a single daily dose of ceftriaxone 2.0g IV infused over 30 minutes, for 7-14 days (patients may be switched to oral ciprofloxacin after 3 doses of IV therapy)

Protocol documents: