ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01288443
Conditions: Hypercholesterolemia
Sponsor: Sanofi
Start date: 2011-01-01; Completion date: 2011-12-01
Enrollment: 183 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Primary Objective:

* To evaluate the effect of alirocumab (SAR236553/REGN727) on low-density lipoprotein cholesterol (LDL-C) levels after 12 weeks of treatment in comparison with placebo in participants with LDL-C ≥ 100 mg/dL (≥ 2.59 mmol/L) on ongoing stable atorvastatin therapy.

Secondary Objectives:

* To evaluate the effects of alirocumab on other lipid levels after 12 weeks of treatment in comparison with placebo
* To evaluate the safety and tolerability of alirocumab
* To evaluate the development of anti-alirocumab antibodies
* To evaluate the pharmacokinetics of alirocumab

Detailed description:
The duration of study participation depended on the status of the participant at screening:

* For participants receiving atorvastatin 10 mg, 20 mg, or 40 mg at a stable dose for at least 6 weeks prior to screening, the study participation was to be approximately 21 weeks including a screening period of 1 week, a double-blind treatment period of 12 weeks and a follow-up period of 8 weeks.
* For participants receiving a lipid-lowering treatment other than atorvastatin or not at stable dose of atorvastatin 10 mg, 20 mg, or 40 mg for at least 6 weeks prior to screening, or drug naive participants, the study participation was to be approximately 27 weeks including a screening period of 1 week, a run-in treatment period with atorvastatin 10 mg, 20 mg, or 40 mg at a stable dose of 6 weeks, a double-blind treatment period of 12 weeks, and a follow-up period of 8 weeks.

Arms: arm 1: Placebo (for alirocumab) every 2 weeks (Q2W) for 12-weeks in combination with atorvastatin stable dose. arm 2: Alirocumab 50 mg Q2W for 12-weeks in combination with atorvastatin stable dose. arm 3: Alirocumab 100 mg Q2W for 12-weeks in combination with atorvastatin stable dose. arm 4: Alirocumab 150 mg Q2W for 12-weeks in combination with atorvastatin stable dose. arm 5: Alirocumab 200 mg every 4 weeks (Q4W) and alternating placebo Q2W for 12-weeks in combination with atorvastatin stable dose. arm 6: Alirocumab 300 mg Q4W and alternating placebo Q2W for 12-weeks in combination with atorvastatin stable dose.
Interventions: intervention 1: Alirocumab intervention 2: Placebo (for alirocumab) intervention 3: Atorvastatin
Intervention descriptions: intervention 1: Two SC injections in the abdomen only. intervention 2: Two subcutaneous (SC) injections in the abdomen only. intervention 3: Orally once daily at a stable dose of 10 mg, 20 mg, or 40 mg as background therapy.

Protocol documents:
Clinical trial NCT01290341
Conditions: Tinea Pedis
Keywords: fungal infection athlete foot
Sponsor: Merz North America, Inc.
Start date: 2011-02-01; Completion date: 2011-12-01
Enrollment: 860 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 6-week, double-blind, randomized, placebo-controlled, multicenter, parallel group Phase 3 study of NAFT-600 applied once a day for 2 weeks compared to vehicle (placebo) in the treatment of tinea pedis.

Detailed description:
This study is open to males and non-pregnant females, 12 years of age and over, with clinical signs and symptoms of tinea pedis consisting of at least moderate erythema, moderate scaling, mild pruritus, a positive screening KOH, and a positive culture.Subjects will be evaluated at Day 1 (baseline), Week 2, Week 4, and Week 6 (follow-up). Adverse events, concomitant medications,and study drug compliance will be reviewed at each visit. Efficacy assessments will include KOH and culture evaluations, clinical signs/symptoms (erythema, scaling, pruritus), and Investigator's Global Assessment.

Arms: arm 1: Topical; applied once daily for two weeks arm 2: Topical; applied once daily for two weeks.
Interventions: intervention 1: NAFT-600 (naftin 2 % gel) intervention 2: Placebo
Intervention descriptions: intervention 1: Topical; applied once daily for two weeks intervention 2: Topical; applied once daily for two weeks.

Protocol documents:
Clinical trial NCT01302899
Conditions: Non-diabetic Nephropathy
Sponsor: Novartis Pharmaceuticals
Start date: 2011-01-01; Completion date: 2011-12-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is designed to primarily assess the effect of aliskiren on albuminuria in patients with non-diabetic nephropathy when treated with ramipril and volume intervention.

Detailed description:

Arms: arm 1: Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.

Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule HCTZ 25 mg o.d.

Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.

Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d. arm 2: Period 1(Day 1 to end of week 6): 1 tablet ramipril 10 mg once daily (o.d.) + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule Hydrochlorothiazide (HCTZ) 25 mg o.d.

Period 2 (Weeks 7 to 12): 1 tablet ramipril 10 mg o.d.+ 1 tablet aliskiren 150 mg in 1st week of period; thereafter, 2 tablets aliskiren 150mg o.d.+ 1 capsule placebo to HCTZ 25 mg o.d.

Period 3 (Weeks 13 to 18): 1 tablet ramipril 10 mg o.d. + 2 tablets aliskiren 150mg o.d. + 1 capsule HCTZ 25 mg o.d.

Period 4 (Weeks 19 to 26): 1 tablet ramipril 10 mg o.d. + 2 tablets placebo to aliskiren 150mg o.d. + 1 capsule placebo to HCTZ 25 mg o.d.
Interventions: intervention 1: Aliskiren intervention 2: Placebo to Aliskiren intervention 3: Hydrochlorothiazide (HCTZ) intervention 4: Placebo to Hydrochlorothiazide (HCTZ) intervention 5: Ramipril
Intervention descriptions: intervention 1: Aliskiren 150 mg (Tablet) intervention 2: Aliskiren 150 mg Matching Placebo (Tablet) intervention 3: HCTZ 25mg (Capsule) intervention 4: HCTZ 25mg (Capsule) Matching Placebo intervention 5: Ramipril 10mg (Tablet)

Protocol documents:
Clinical trial NCT01311661
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2011-03-01; Completion date: 2011-12-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will compare efficacy and safety of different regimens of olodaterol administration in asthma (once daily, twice daily) with placebo in a complete cross-over design each within one of the two daily dose groups (medium or high daily dose).

Detailed description:

Arms: arm 1: Olodaterol medium daily dose given either as once daily or split into two low doses daily or placebo only in randomised sequence of three cross-over treatment phases arm 2: Olodaterol high daily dose given either as once daily or split into two medium doses daily or placebo only in randomised sequence of three cross-over treatment phases
Interventions: intervention 1: Placebo twice daily intervention 2: Olodaterol low daily dose twice daily intervention 3: Olodaterol medium daily dose twice daily intervention 4: Placebo twice daily intervention 5: Olodaterol high daily dose once daily and placebo intervention 6: Olodaterol medium daily dose once daily and placebo
Intervention descriptions: intervention 1: Inhaled Placebo of Olodaterol twice daily intervention 2: Inhaled Olodaterol medium daily dose administered as low dose twice daily intervention 3: Inhaled Olodaterol high daily dose administered as medium dose twice daily intervention 4: Inhaled Placebo of Olodaterol twice daily intervention 5: Inhaled Olodaterol high daily dose administered as one full dose once daily and placebo once daily intervention 6: Inhaled Olodaterol medium daily dose administered as one full dose once daily and placebo once daily

Protocol documents:
Clinical trial NCT01316315
Conditions: Asthma
Sponsor: Nivalis Therapeutics, Inc.
Start date: 2011-03-01; Completion date: 2011-12-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to determine whether a single IV dose of N6022 will have a significant bronchoprotective effect, compared with placebo, during methacholine challenge.

Detailed description:
The number of patients with adverse events measured in both the treated and placebo groups from start of dosing until Day 28 post dose.

Arms: arm 1: N6022 - 5 mg arm 2: Placebo
Interventions: intervention 1: Active intervention 2: Placebo
Intervention descriptions: intervention 1: A 5 mg single dose given intravenously via syringe pump over 1 minute. intervention 2: Same as active

Protocol documents:
Clinical trial NCT01334710
Conditions: Liver Cancer
Keywords: Liver cancer
Sponsor: Emory University
Start date: 2011-03-01; Completion date: 2011-12-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effect of combining a new investigational drug (OSI-906) with a standard drug (sorafenib) on the control of liver cancer (hepatocellular cancer). Sorafenib (brand name Nexavar®) is a drug that is approved for the treatment of advanced liver cancer. It works by stopping the growth of new blood vessels around the tumor. OSI-906 is an investigational agent that works by inhibiting the effects of a growth hormone on the cancer. The safety and efficacy of combining OSI-906 and sorafenib in the treatment of liver cancer risk not known. The current study will confirm the safety of the combination in the first six patients and evaluate the activity of the combination in patients with advanced liver cancer.

In addition, the study will aim at collecting blood samples from patients to evaluate the level of OSI-906 in patients receiving the combination of the two drugs. The study also will collect samples of the tumor to evaluate for markers that can predict in which patient the combination is effective.

Detailed description:
The purpose of the trial is first to evaluate the safety of the combination of OSI-906 and sorafenib in patients with hepatocellular cancer (HCC). Patients will be treated in groups of three with full dose sorafenib and OSI-906. If we do not observe any significant side effects, then three additional patients will be treated at the same dose level. After confirming the safety of the combination (possibly after first six patients) the study will proceed with regular accrual. The patients will receive the treatments orally and will be evaluated by physical exam, blood work and imaging. If the cancer is well controlled and the therapy is well tolerated then patients will continue on the trial. If the side effects are significant or the tumor starts to grow or the patients wishes to stop therapy the patient at that time will be taken off trial.

The trial will collect blood samples to evaluate the level of the investigational agent in the blood. Also samples of the patients tumor will be analyzed to evaluate for markers that may predict who benefits from treatment.

Arms: arm 1: This is a single arm phase II trial designed to evaluate the effect of adding OSI-906 to sorafenib in patients with hepatocellular cancer. The study is designed to evaluate the safety of the regimen in the first six patients.
Interventions: intervention 1: Sorafenib and OSI-906
Intervention descriptions: intervention 1: Sorafenib - 400 mg twice daily OSI-906 - 150 mg twice daily

Protocol documents:
Clinical trial NCT01367249
Conditions: Pain Inflammation Cataract
Keywords: cataract surgery
Sponsor: Bausch & Lomb Incorporated
Start date: 2011-05-01; Completion date: 2011-12-01
Enrollment: 440 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an efficacy study of Bromfenac Ophthalmic Solution in cataract surgery.

Detailed description:

Arms: arm 1: Bromfenac ophthalmic solution 0.07% one drop into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days. arm 2: One drop of placebo into study eye, once daily (QD) starting the day before cataract surgery and continued for 14 days post surgery for a total of 16 days.
Interventions: intervention 1: Bromfenac Ophthalmic Solution intervention 2: Placebo
Intervention descriptions: intervention 1: Sterile ophthalmic solution intervention 2: Sterile ophthalmic solution

Protocol documents:
Clinical trial NCT01371643
Conditions: Pituitary Adenoma
Sponsor: NYU Langone Health
Start date: 2004-04-01; Completion date: 2011-12-01
Enrollment: 41 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a randomized, multicenter trial with stratification done by a single radiologist at the coordinating center (NYU), and patients with comparable disease will be randomized to Sandostatin LAR treatment administered 1 time per month by IM injection for 3 months before (Arm A) or, for non-cured patients, after (Arm B) surgery. All patients will undergo transsphenoidal hypophysectomy. The impact of surgical debulking on responsiveness to Sandostatin LAR will be evaluated.The primary objective of this trial will be to determine whether surgery (debulking of pituitary adenomas) improves the response of patients with acromegaly to treatment with Octreotide LAR, when compared to Octreotide LAR therapy alone.

Detailed description:
The current goal of treatment for people with acromegaly is normalization of both growth hormone (GH) and insulin-like-growth-factor-1 (IGF-1) levels. Normalization of GH and IGF-1 levels attenuates the morbidity (hypertension, cardiovascular disease, sleep apnea, increased cancer risk, arthritis) and increased mortality associated with persistent GH and IGF-1 elevation. The optimal approach to achieving these goals in patients with pituitary macroadenomas remains controversial. Available treatment modalities include transsphenoidal hypophysectomy, medical therapy (somatostatin analogues and/or dopaminergic agonists), radiotherapy, or a combination or these interventions. No randomized trials have been conducted to investigate whether surgical debulking of pituitary macroadenomas enhances the efficacy of medical therapy. This study is designed to rigorously investigate whether surgical debulking increases the efficacy of a long-acting depot somatostatin preparation, Sandostatin LAR, so that evidence-based optimal care may be offered to patients with acromegaly.

Arms: arm 1: Medical therapy with Octreotide LAR 30 mg/month for 3 months preceding surgery arm 2: Surgical debulking of pituitary tumor followed by Octreotide LAR if not surgically cured
Interventions: intervention 1: Octreotide LAR intervention 2: transsphenoidal surgery
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01373931
Conditions: Depressive Disorder, Major
Sponsor: Eli Lilly and Company
Start date: 2011-06-01; Completion date: 2011-12-01
Enrollment: 20 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study involves a single dose of 18 milligrams (mg) LY2216684 taken as 1 or 2 tablets by mouth. The study will evaluate effect of LY2216684 on the pharmacokinetics of an oral contraceptive Ortho Cyclen®. This study will run approximately 93 days.

Detailed description:

Arms: arm 1: 28-day lead-in period of Ortho Cyclen (OC; 28-day packet), followed by randomization to OC administered orally once daily for 28 days + 18 milligrams (mg) of LY2216684 administered concomitantly orally once daily for 21 days, followed by OC administered orally once daily for 28 days + placebo administered concomitantly orally once daily for 21 days. arm 2: 28-day lead-in period of OC (28-day packet), followed by randomization to OC administered orally once daily for 28 days + placebo administered concomitantly orally once daily for 21 days, followed by OC administered orally once daily for 28 days + 18 mg of LY2216684 administered concomitantly orally once daily for 21 days.
Interventions: intervention 1: LY2216684 intervention 2: Ortho Cyclen intervention 3: Placebo
Intervention descriptions: intervention 1: Administered orally intervention 2: 35 micrograms (mcg) ethinyl estradiol and 250 mcg norgestimate administered orally intervention 3: Administered orally

Protocol documents:
Clinical trial NCT01383109
Conditions: Malaria
Keywords: Mass Balance Accelerated Mass Spectrometry (AMS) microdose Focus of the study: ADME
Sponsor: Medicines for Malaria Venture
Start date: 2011-06-01; Completion date: 2011-12-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The combination of pyronaridine and artesunate is an antimalarial therapy in development. This mass balance study is intended to determine the rate and extent of excretion of total radioactivity in urine and feces following administration of a single oral micro-dose of 14C-pyronaridine in humans.

Detailed description:
This is a monocenter, open-label, non-placebo-controlled, single-group, single-dose study. Six male subjects will receive a single dose of Pyronaridine 720 mg orally administered together with 14C-Pyronaridine (approx. 100 µg, 800 nCi (29600 Bq)).

Safety measurements (12-lead ECG, vital signs, blood chemistry and haematology) and adverse events will be monitored throughout the study. Subjects will come to the clinic the evening before the dosing of Pyronaridine. After the drug intake at day 1, subjects will have regular in-house periods for specimen collection up to 87 days after the drug administration. Blood, feces and urine will be collected during the hospitalisation periods. Samples will be analyzed for radioactivity by Accelerator Mass Spectrometry (AMS).

Arms: arm 1: All subjects will receive a single dose of Pyronaridine
Interventions: intervention 1: 14C-labeled Pyronaridine
Intervention descriptions: intervention 1: Single dose of 720 mg Pyronaridine together with 14C-Pyronaridine (approx. 100 µg, 800 nCi).

Protocol documents:
Clinical trial NCT01383356
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2011-06-01; Completion date: 2011-12-01
Enrollment: 58 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The data from this study will be used to compare the kinetic profile of metformin 500mg in linagliptin/metformin fixed dose combination tablet versus Canadian metformin reference product administered concomitantly with linagliptin 2.5 mg tablet.

Detailed description:

Arms: arm 1: patient to receive a single medium dose combination tablet containing Linagliptin and Metformin once daily arm 2: patient to receive two individual tablets: Linagliptin and Metformin (medium dose)
Interventions: intervention 1: Metformin Single Tablet intervention 2: Linagliptin/Metformin Combo intervention 3: Linagliptin Single Tablet
Intervention descriptions: intervention 1: Metformin medium doseTablet intervention 2: Fixed dose combination intervention 3: Linagliptin Single medium dose Tablet

Protocol documents:
Clinical trial NCT01387347
Conditions: Dry Eye Syndrome Dry Eye
Keywords: Thymosin beta 4 Dry eye syndrome Dry eye
Sponsor: ReGenTree, LLC
Start date: 2011-08-01; Completion date: 2011-12-01
Enrollment: 72 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Thymosin Beta 4 (Tβ4) is a synthetic copy of the naturally-occurring 43-amino acid peptide that is found in a variety of tissues. Tβ4 promotes/accelerates wound repair in dermal, ocular, and cardiac animal models. Two recent pre-clinical evaluations have demonstrated that Tβ4 promotes corneal ocular surface defects healing in animal models of dry eye. RGN-259 (formulation of Tβ4 ophthalmic solution) mechanism of action offers potential to be a product that meets a major unmet medical need in patients with dry eye.

Detailed description:
Tβ4 promotes wound repair and regeneration in various tissues. In the eye, it promotes corneal epithelial cell migration, decreases inflammation and has anti-apoptotic activities. It up-regulates the gene expression of laminin-5, a major subepithelial adhesion protein, located in the basement membrane region of the cornea, conjunctiva, and important in wound healing. In compassionate-use cases, Tβ4 has demonstrated efficacy in repairing non-healing neurotrophic corneal ulcers and other corneal epithelial wounds. In twenty-four nonclinical toxicology and safety pharmacology studies, the safety of Tβ4 has been demonstrated for its current and planned uses in man. The results of the two recent dry eye murine mouse model studies show that Tβ4 reduced corneal staining more than positive controls and demonstrated statistically significant reduction in staining compared to vehicle control. The results of these studies, in addition to data from compassionate use studies in patients with non-healing corneal surface defects, suggests that Tβ4 has a significant potential to be an important new safe and effective therapeutic in the treatment of dry eye syndrome.

Arms: arm 1: RGN-259 is a preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 arm 2: The placebo solution is composed of the same excipients as RGN-259 but does not contain Tβ4. The Placebo is identical to the RGN-259 eye drops in color, consistency, and odor.
Interventions: intervention 1: Thymosin beta 4 intervention 2: Placebo
Intervention descriptions: intervention 1: A preservative-free, sterile eye drop solution containing 0.1% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days. intervention 2: A preservative-free, sterile eye drop solution containing 0.0% (w/w) Tβ4 for direct instillation into each eye, twice a day (BID) for 28 days.

Protocol documents:
Clinical trial NCT01388920
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD Muscle wasting
Sponsor: Theratechnologies
Start date: 2011-09-01; Completion date: 2011-12-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A significant proportion of COPD subjects experience muscle wasting, which has been associated with increased morbidity, impaired physical functioning, and a poor quality of life.

Muscle wasting is associated with reduced muscle strength in COPD subjects. In particular, weakness of peripheral muscles has been reported to play an important role in the reduced functional capacity and impaired exercise performance.

The primary objective of this study is to investigate the effect of tesamorelin, in conjunction with exercise training, on lean body mass measured by dual energy x-ray absorptiometry (DXA) scan.

Detailed description:

Arms: arm 1: Tesamorelin 2 mg/day arm 2: Tesamorelin 3 mg/day arm 3: Placebo
Interventions: intervention 1: Tesamorelin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents: