ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00750152
Conditions: Tinea Cruris Jock Itch
Keywords: tinea cruris jock itch
Sponsor: Merz North America, Inc.
Start date: 2008-09-01; Completion date: 2010-02-01
Enrollment: 334 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A research study to compare the safety and effectiveness of an investigational medication called NAFT-500 to placebo (no active treatment), when used in subjects with tinea cruris, also known as jock itch.

Detailed description:
To evaluate the efficacy and safety of NAFT-500, applied once daily for 2 weeks, compared to placebo in the treatment of subjects with potassium hydroxide (KOH) and culture positive symptomatic tinea cruris.

Arms: arm 1: placebo arm 2: NAFT-500
Interventions: intervention 1: NAFT-500 intervention 2: Placebo
Intervention descriptions: intervention 1: topical cream application up to 4 weeks intervention 2: placebo cream applied for up to 4 weeks

Protocol documents:
Clinical trial NCT00762528
Conditions: Gingivitis
Sponsor: Colgate Palmolive
Start date: 2009-02-01; Completion date: 2010-02-01
Enrollment: 49 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Plaque induced gingivitis

Detailed description:

Arms: arm 1: Triclosan/Copolymer/fluoride toothpaste arm 2: sodium monofluorophosphate toothpaste
Interventions: intervention 1: Triclosan/Copolymer/fluoride toothpaste intervention 2: Sodium monofluorophosphate toothpaste
Intervention descriptions: intervention 1: Twice daily usage intervention 2: Twice daily usage

Protocol documents:
Clinical trial NCT00770341
Conditions: Staphylococcal Infection
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-09-01; Completion date: 2010-02-01
Enrollment: 122 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study investigates the efficacy and safety of MK-3009 in participants with skin infections, septicemia and right-sided infective endocarditis (RIE) caused by methicillin-resistant Staphylococcus aureus (MRSA).

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: Daptomycin 4 mg/kg intervention 2: Comparator: vancomycin intervention 3: Daptomycin 6 mg/kg
Intervention descriptions: intervention 1: MK3009 (daptomycin) once daily by intravenous (IV) drip, 4 mg/kg for 7-14 days for skin and soft tissue infections (SSTI) intervention 2: vancomycin 1g, twice daily (b.i.d.) by IV drip, for 7-14 days intervention 3: MK-3009 (daptomycin) once daily by intravenous drip, 6 mg/kg for 14-42 days for septicemia or right-sided infective endocarditis

Protocol documents:
Clinical trial NCT00773383
Conditions: Non-Small Cell Lung Cancer
Sponsor: Hoffmann-La Roche
Start date: 2008-11-01; Completion date: 2010-02-01
Enrollment: 35 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This single arm study in patients with advanced Stage IIIb/IV NSCLC who have progressive disease after deriving clinical benefit (defined as response or stable disease after 12 weeks) from second or third line Tarceva monotherapy will determine the proportion of patients with progression-free survival at 12 weeks following combination therapy with R1507 and Tarceva. Patients will receive R1507 (9mg/kg iv) weekly in combination with Tarceva (150mg oral daily) for up to a maximum of 24 months. Other disease-related endpoints including overall survival, objective response rate, time to response, time to progressive disease and duration of response will also be evaluated. The anticipated time on study treatment is 1-2 years, and the target sample size is \<100 individuals.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: RG1507 intervention 2: erlotinib [Tarceva]
Intervention descriptions: intervention 1: iv 9mg/kg weekly intervention 2: 150mg oral daily

Protocol documents:
Clinical trial NCT00791557
Conditions: Pyoderma Gangrenosum Crohn's Disease Ulcerative Colitis Inflammatory Bowel Disease
Sponsor: University Hospitals Cleveland Medical Center
Start date: 2008-10-01; Completion date: 2010-02-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum.

This is a 6 month open label study of an intravenous (IV) medication. Visits occur every 2 weeks initially, then every 1-2 months later in the study.

Detailed description:

Arms: arm 1: Single arm open label IV Infliximab given at weeks 1,2,14,22
Interventions: intervention 1: Infliximab
Intervention descriptions: intervention 1: IV drug given at weeks 1,2,14,22

Protocol documents:
Clinical trial NCT00792805
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD indacaterol long-acting β2-agonist adults
Sponsor: Novartis Pharmaceuticals
Start date: 2008-11-01; Completion date: 2010-02-01
Enrollment: 563 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study evaluated the efficacy and safety of two doses of indacaterol in adults aged 40 or over with chronic obstructive pulmonary disease (COPD) in China and in two other countries.

Detailed description:

Arms: arm 1: Patients inhaled indacaterol 150 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 2: Patients inhaled indacaterol 300 μg via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study. arm 3: Patients inhaled placebo to indacaterol via a single-dose dry-powder inhaler (SDDPI) once daily (od) in the morning (between 8:00 and 11:00 AM) for 26 weeks. Daily inhaled corticosteroid treatment (if applicable) was to remain stable throughout the study. The short-acting β2-agonist salbutamol/albuterol was available for rescue use throughout the study.
Interventions: intervention 1: Indacaterol 150 µg intervention 2: Indacaterol 300 μg intervention 3: Placebo to indacaterol
Intervention descriptions: intervention 1: Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 2: Indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI). intervention 3: Placebo to indacaterol was supplied in powder-filled capsules with a single-dose dry-powder inhaler (SDDPI).

Protocol documents:
Clinical trial NCT00792935
Conditions: Type 2 Diabetes Mellitus
Sponsor: Merck Sharp & Dohme LLC
Start date: 2009-01-01; Completion date: 2010-02-01
Enrollment: 143 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to test the effect of MK-0941 as add-on therapy for participants taking metformin for type 2 diabetes.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: MK-0941 intervention 2: Glimepiride intervention 3: Metformin
Intervention descriptions: intervention 1: MK-0941 will be taken three times a day (TID), within 15 minutes before each meal. MK-0941 will be titrated to a maximally effective dose. The treatment period will be 6 weeks. intervention 2: Glimepiride will be taken once a day (QD) in the morning, within 15 minutes before the breakfast meal. Glimepiride will be titrated to a maximally effective dose. The treatment period is 6 weeks. intervention 3: The study will include an up to 4-week metformin dose titration/dose stabilization period. Once a participant has reached the maximum tolerated dose of metformin \[(i.e., ≥1500 mg/day and ≤2550 mg/day (or ≤3000 mg/day, where the maximum dose of metformin per the local label is 3000 mg/day)\], the participant should remain on the same metformin dose throughout the study.

Protocol documents:
Clinical trial NCT00804570
Conditions: Alcohol Dependence
Sponsor: Eli Lilly and Company
Start date: 2008-11-01; Completion date: 2010-02-01
Enrollment: 375 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The Primary objective of this study is to test whether LY2196044 can reduce the number of heavy drinking days per month in people with alcohol dependence. Each subject will undergo a screening and assessment period (including medication washout) prior to randomization into a 16 week double blind treatment period.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: LY2196044 intervention 2: placebo
Intervention descriptions: intervention 1: 250 milligram (mg) (titrate via 1 week at 50 mg and 1 week at 125 mg), once daily, orally, 16 weeks intervention 2: once daily, orally, 16 weeks

Protocol documents:
Clinical trial NCT00805870
Conditions: Muscle Damage Muscle Inflammation
Sponsor: Western Michigan University
Start date: 2009-03-01; Completion date: 2010-02-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the effects of fish oil supplementation (Lovaza, GlaxoSmithKline) on muscle strength, muscle soreness and inflammation following exercise.

Detailed description:
When a person exercises at a high intensity or starts a new exercise program, muscle soreness will develop. Muscle soreness that peaks between 24-72 hours after exercise and diminishes in 5-7 days is characterized as delayed onset muscle soreness (DOMS). DOMS is associated with the eccentric phase of exercise, where the muscle is actively creating force while lengthening. The onset of muscle soreness is part of an inflammatory response due to the muscular damage caused by the exercise.

Research has shown that fish oils have anti-inflammatory properties. Direct intake of various polyunsaturated fatty acids (PUFA) alters the cell membrane fatty acid composition, which, in turn modulates cell/tissue response to infection, injury and inflammatory events. These properties may be beneficial to relieve muscle soreness.

Therefore, the purpose of this study is to determine the effects of fish oil supplementation (Lovaza, GlaxoSmithKline, 3 grams per day for 65 days) on muscle strength, muscle soreness and inflammation following exercise.

Participants will be randomly assigned to one of two groups: Lovaza (3 grams/day) or placebo. Participants will consume either the Lovaza or the placebo for 65 consecutive days. On Day 60, participants will have baseline measurements of muscle strength, muscle soreness, creatine kinase activity, and muscle inflammatory marker assessed. Participants will then perform eccentric exercise on an isokinetic dynamometer using the quadriceps muscles in order to induce muscle soreness. On each of Days 61-65, muscle strength, muscle soreness, creatine kinase activity, and muscle inflammatory markers will again be assessed.

Arms: arm 1: Lovaza, 3 grams/day for 65 days arm 2: Wheat Germ Oil, 3 grams/day for 65 days
Interventions: intervention 1: Lovaza (omega-3-acid ethyl esters) intervention 2: Wheat Germ Oil
Intervention descriptions: intervention 1: Lovaza, 3 grams per day for 65 days intervention 2: Wheat germ oil, 3 grams/day for 65 days

Protocol documents:
Clinical trial NCT00809471
Conditions: Erectile Dysfunction
Keywords: ED Erectile Dysfunction Dysfunction Diabetic Erectile
Sponsor: VIVUS LLC
Start date: 2008-12-01; Completion date: 2010-02-01
Enrollment: 390 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is being conducted to compare the safety and efficacy of 2 doses of avanafil to placebo in diabetic men with mild to severe erectile dysfunction.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: placebo intervention 2: avanafil intervention 3: avanafil
Intervention descriptions: intervention 1: 30 minutes orally prior to initiation of sexual activity intervention 2: 30 minutes orally prior to initiation of sexual activity intervention 3: 30 minutes orally prior to initiation of sexual activity

Protocol documents:
Clinical trial NCT00825227
Conditions: Fatigue Chemotherapy Side Effects
Keywords: Cancer Fatigue Taxanes
Sponsor: Cephalon
Start date: 2008-12-01; Completion date: 2010-02-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the Safety and Efficacy of Armodafinil Treatment for Patients With Fatigue Associated With Taxane Chemotherapy Alone or in Combination With Other Agents

Detailed description:
The primary objective of study was to determine whether armodafinil treatment at a dose of 150 mg/day is more effective than placebo treatment in reducing fatigue in patients receiving taxane chemotherapy alone or in combination with other agents by comparing the change from Screening cycle to treatment cycle (cycle 2) in the patient's average daily rating of their worst fatigue severity during the past 24 hours. In addition, the change in the percentage of days with severe fatigue and the mean Brief Fatigue Inventory scores were to be recorded.

Arms: arm 1: * 150 mg/day armodafinil
* taxane chemotherapy treatment alone or in combination with other agents arm 2: * placebo
* taxane chemotherapy treatment alone or in combination with other agents
Interventions: intervention 1: Armodafinil 150 mg/day intervention 2: Placebo,
Intervention descriptions: intervention 1: * 150 mg/day armodafinil
* concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
* patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents intervention 2: * placebo
* concurrent with one cycle of taxane chemotherapy alone or in combination with other agents
* patients may then continue receiving armodafinil treatment after the double-blind treatment period by entering a 24-week open-label extension period, with continuing taxane chemotherapy alone, or in combination with other agents

Protocol documents:
Clinical trial NCT00845702
Conditions: Renal Artery Stenosis
Keywords: Renal artery stenosis Contrast agent MRA
Sponsor: Guerbet
Start date: 2009-04-01; Completion date: 2010-02-01
Enrollment: 33 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Detailed description:
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Arms: arm 1: Each subject will receive one injection of Dotarem 0.2 ml/kg. arm 2: Each subject undergo a TOF MRA
Interventions: intervention 1: Gadoterate meglumine (Dotarem) intervention 2: Time of Flight Magnetic Resonance Angiography
Intervention descriptions: intervention 1: Each subject will receive one injection of Dotarem 0.2 ml/kg intervention 2: Each subject will undergo a TOF MRA

Protocol documents:
Clinical trial NCT00846651
Conditions: Hypotension
Keywords: spinal anesthesia cesarean section
Sponsor: Milton S. Hershey Medical Center
Start date: 2009-02-01; Completion date: 2010-02-01
Enrollment: 82 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections.

Detailed description:
Many women experience low blood pressure after spinal anesthesia for Cesarean section. This low blood pressure may result in nausea, vomiting dizziness and impairment of uterine blood flow.The purpose of this study is to compare two methods for preventing low blood pressure associated with spinal anesthesia during Cesarean sections. In both methods, we will attempt to prevent low blood pressure using phenylephrine infusion that has been shown to be effective in recent research. In addition to receiving phenylephrine one group of patients will receive standard salt solution (Ringer's lactate solution), while the other group will receive a different, intravenous fluid called hydroxyethylstarch.

Arms: arm 1: colloid administration; with 0.5 L Hydroxyethylstarch solution at a rate of 17 ml/min and completed over 30 min. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision. arm 2: crystalloid administration; The patients received 1.5 L Ringer's lactate infusion at a rate of 50 ml/min and completed over 30 min prior to spinal anesthesia for cesarean section. A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.
Interventions: intervention 1: Colloid administration intervention 2: Crystalloid administration intervention 3: phenylephrine infusion
Intervention descriptions: intervention 1: The patients received 0.5 L colloid solution (hydroxyethylstarch 6%) or 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section. intervention 2: The patients received 1.5 L Ringer lactate prior to spinal anesthesia for cesarean section. intervention 3: A phenylephrine infusion will be started immediately after performing the spinal anesthesia and continued until time of uterine incision.

Protocol documents:
Clinical trial NCT00852696
Conditions: Overactive Bladder
Keywords: Overactive Bladder Incontinence Solifenacin Women Postoperative
Sponsor: Cleveland Clinic Florida
Start date: 2008-02-01; Completion date: 2010-02-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether treatment with anti-muscarinic medications following sub-urethral sling procedures improves overall subjective and objective outcomes in women with mixed incontinence with primary stress symptoms.

Detailed description:
Women with mixed incontinence with primary stress symptoms undergoing Sub-Urethral Sling Procedures will be randomized to peri-operative placebo or solifenacin. Subjects in the placebo group will take orally once daily for 9 weeks. Subjects in the Solifenacin group will take orally once daily for 9 weeks.

Arms: arm 1: Placebo Orally 9 weeks once daily. arm 2: Solifenacin Orally 9 weeks once daily.
Interventions: intervention 1: Solifenacin intervention 2: Placebo
Intervention descriptions: intervention 1: Solifenacin is used to treat overactive bladder. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination. Take orally once daily for 9 weeks. intervention 2: Take orally once daily for 9 weeks.

Protocol documents:
Clinical trial NCT00855920
Conditions: Acute Gout Flare
Keywords: Metabolism, Inborn Errors Allopurinol Metabolic Diseases Genetic Diseases, Inborn Musculoskeletal Diseases Joint Diseases Arthritis Rheumatic Diseases Metabolic disorder Purine-Pyrimidine Metabolism, Inborn Errors Gout Flare
Sponsor: Regeneron Pharmaceuticals
Start date: 2009-03-01; Completion date: 2010-02-01
Enrollment: 225 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This purpose of this clinical research was to determine the efficacy and safety of an experimental drug called Rilonacept in participants with an acute gout attack. Participants participated in this study for 30 days. Rilonacept alone was being compared with Indomethacin alone and the combination of Rilonacept plus Indomethacin in treating acute gout flares.

Detailed description:

Arms: arm 1: Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 with Indomethacin orally thrice a day (TID) for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). arm 2: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). arm 3: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 with Placebo (for Indomethacin) orally TID for 12 days.
Interventions: intervention 1: Rilonacept intervention 2: Indomethacin intervention 3: Placebo (for Indomethacin) intervention 4: Placebo (for Rilonacept)
Intervention descriptions: intervention 1: Two subcutaneous injections of Rilonacept 160 mg (for a total of 320 mg) on Day 1 (Baseline). intervention 2: Indomethacin orally TID for 12 days (Indomethacin 50 mg for first 3 days and then, Indomethacin 25 mg for next 9 days). intervention 3: Placebo (for Indomethacin) orally TID for 12 days. intervention 4: Two subcutaneous injections of Placebo (for Rilonacept) on Day 1 (Baseline).

Protocol documents:
Clinical trial NCT00862654
Conditions: Scalp Seborrheic Dermatitis
Sponsor: Galderma R&D
Start date: 2009-03-01; Completion date: 2010-02-01
Enrollment: 326 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in the treatment of scalp Seborrheic Dermatitis.

Detailed description:
The objective is to assess different treatment regimens with Clobetasol propionate shampoo 0.05% in association with an antifungal shampoo (Ketoconazole 2%) in the treatment of moderate to severe scalp Seborrheic Dermatitis compared to the antifungal shampoo alone.

Arms: arm 1: Clobetasol propionate shampoo 0.05% (4/week) + Ketoconazole shampoo 2% (2/week) arm 2: Clobetasol propionate shampoo 0.05% (2/week) + Ketoconazole shampoo 2% (2/week) arm 3: Clobetasol propionate shampoo 0.05% (2/week) arm 4: Ketoconazole shampoo 2% (2/week)
Interventions: intervention 1: clobetasol propionate shampoo (4/week) - ketoconazole shampoo (2/week) intervention 2: clobetasol propionate shampoo (2/week) - ketoconazole shampoo (2/week) intervention 3: clobetasol propionate shampoo (2/week) intervention 4: ketoconazole shampoo (2/week)
Intervention descriptions: intervention 1: Association: clobetasol propionate shampoo \& ketoconazole shampoo intervention 2: Association: clobetasol propionate shampoo \& ketoconazole shampoo intervention 3: Monotherapy with clobetasol propionate shampoo intervention 4: Monotherpay ketoconazole shampoo (2/week)

Protocol documents: