ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00838110
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease Dimebon Safety Tolerability
Sponsor: Pfizer
Start date: 2009-02-01; Completion date: 2010-01-01
Enrollment: 742 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a multi-center, randomized, double-blind placebo-controlled safety study conducted in 2 study cohorts. In Cohort 1, subjects with Alzheimer's disease (n=250) will receive Dimebon 20 mg or placebo TID for 26 weeks. In Cohort 2 AD subjects (n=500) will be treated with Dimebon 20 mg or placebo TID for 12 weeks After completion of the randomized portion of the study, subjects in both Cohorts will have the opportunity to enroll in a Dimebon open label extension study.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Dimebon intervention 2: Placebo intervention 3: Dimebon intervention 4: Placebo
Intervention descriptions: intervention 1: 10 mg TID for week 1 followed by 20 mg TID through Week 26 intervention 2: 10 mg TID for week 1 followed by 20 mg TID through Week 26 intervention 3: 10 mg TID for week 1 followed by 20 mg TID through Week 12 intervention 4: 20 mg matched Placebo (Cohort 2) 10 mg TID for week 1 followed by 20 mg TID through Week 12

Protocol documents:
Clinical trial NCT00839306
Conditions: Gastroesophageal Reflux Disease (GERD)
Keywords: Gastroesophageal Reflux Disease GERD
Sponsor: Eisai Inc.
Start date: 2008-08-01; Completion date: 2010-01-01
Enrollment: 240 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the efficacy of rabeprazole extended release 50 mg (once daily) versus ranitidine 150 mg (twice daily) in the maintenance of complete healing in subjects with healed erosive gastroesophageal reflux disease (eGERD).

Detailed description:
This is a multicenter, randomized, double-blind, double-dummy, parallel-group study. Subjects who meet all eligibility criteria will be randomly assigned to 1 of 2 treatment groups, rabeprazole extended release 50 mg (once daily) or ranitidine 150 mg (twice daily).

Please note that this study is not a duplicate of E3810-G000-305; this is a separate study being conducted along with -305.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Rabeprazole ER intervention 2: Ranitidine
Intervention descriptions: intervention 1: 50 mg capsule, taken orally, once daily for 26 weeks. intervention 2: 150 mg capsule, taken orally, twice daily for 26 weeks.

Protocol documents:
Clinical trial NCT00848536
Conditions: Open Angle Glaucoma Ocular Hypertension
Keywords: OAG OHT
Sponsor: Alcon Research
Start date: 2009-03-01; Completion date: 2010-01-01
Enrollment: 371 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Multi-Center Double-masked Study of the Safety and Efficacy of Travoprost APS Compared to TRAVATAN in Patients with Open-angle Glaucoma or Ocular Hypertension

Detailed description:

Arms: arm 1: One drop once daily in the evening for 3 months arm 2: One drop once daily in the evening for 3 months
Interventions: intervention 1: Travoprost 0.004% (POLYQUAD-preserved) Eye Drops, Solution intervention 2: Travoprost 0.004% (BAK-preserved) Eye Drops, Solution
Intervention descriptions: intervention 1: One drop once daily in the evening for 3 months intervention 2: One drop once daily in the evening for 3 months

Protocol documents:
Clinical trial NCT00859573
Conditions: Methamphetamine Dependence
Sponsor: University of Arkansas
Start date: 2009-04-01; Completion date: 2010-01-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Fifty methamphetamine dependent treatment-seeking volunteers will be enrolled in this 10 week, double bind, placebo controlled, randomized clinical trial to receive either modafinil or placebo. Eligible subjects will reside at the Recovery Centers of Arkansas residential facility to achieve initial abstinence and be inducted onto study medication during wks 1-2. Then during wks 3-10, subjects participate on an outpatient basis, receiving weekly psychotherapy while continuing to receive study medications. Urine samples will be collected thrice weekly and self reports weekly to assess methamphetamine use. It is hoped that the results of this study will contribute to our understanding of which types of agents may be good candidates for further development as potential treatment agents for this disorder.

Detailed description:

Arms: arm 1: None arm 2: Placebo
Interventions: intervention 1: Modafinil intervention 2: Placebo
Intervention descriptions: intervention 1: 400 mg/day intervention 2: inactive substance

Protocol documents:
Clinical trial NCT00866788
Conditions: Chronic Idiopathic Urticaria
Keywords: Xolair CIU
Sponsor: Genentech, Inc.
Start date: 2009-03-01; Completion date: 2010-01-01
Enrollment: 90 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study is a Phase II, dose-ranging, multicenter, randomized, double-blind, placebo-controlled, parallel-group study of the efficacy and safety of a single subcutaneously administered omalizumab dose as add-on therapy for the treatment of adolescent and adult patients 12-75 years old who have been diagnosed with CIU and remain symptomatic despite treatment with therapeutic doses of an H1 antihistamine. The study will enroll approximately 76 patients at approximately 45 study centers in the United States and Germany.

Detailed description:

Arms: arm 1: Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.). arm 2: Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis. arm 3: Omalizumab (Xolair) was administered subcutaneously on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria (CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis. arm 4: Participants received a single subcutaneous placebo injection on Day 0 of the study. Participants remained on stable doses of their pre-allocation Chronic Idiopathic Urticaria CIU) H1 antihistamine treatment throughout the study, and were provided diphenhydramine as rescue medication for pruritus relief on an as-needed basis.
Interventions: intervention 1: omalizumab intervention 2: placebo intervention 3: H1 antihistamines intervention 4: Diphenhydramine
Intervention descriptions: intervention 1: Administered by subcutaneous injection intervention 2: Participants received a single subcutaneous placebo injection on Day 0 of the study. intervention 3: Patients received one of the following: Cetirizine 10 mg once per day (QD), Levocetirizine dihydrochloride 5 mg QD, Fexofenadine 60 mg twice per day or 180 mg QD, Loratadine 10 mg QD or Desloratadine 5 mg QD intervention 4: Diphenhydramine was provided and used on an as-needed basis (25 mg per dose)

Protocol documents:
Clinical trial NCT00867139
Conditions: Influenza
Keywords: Influenza Immunocompromised Antiviral
Sponsor: Fred Hutchinson Cancer Center
Start date: 2009-03-01; Completion date: 2010-01-01
Enrollment: 7 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the safety and tolerability of triple combination antiviral drug (TCAD) for use in immunocompromised patients with Influenza A infection, and to gain data on the effectiveness of TCAD

Detailed description:

Arms: arm 1: TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate) arm 2: Zanamivir or Oseltamivir arm 3: TCAD for subjects who cannot tolerate or are ineligible to receive zanamivir
Interventions: intervention 1: TCAD intervention 2: Zanamivir or Oseltamivir intervention 3: Open label treatment with TCAD
Intervention descriptions: intervention 1: TCAD (amantadine hydrocholoride, ribavirin and oseltamivir phosphate) intervention 2: Zanamivir or Oseltamivir intervention 3: TCAD(amantadine hydrocholoride, ribavirin and oseltamivir phosphate)

Protocol documents:
Clinical trial NCT00877890
Conditions: Type 2 Diabetes Mellitus
Keywords: diabetes exenatide once weekly Byetta Amylin Lilly Bydureon
Sponsor: AstraZeneca
Start date: 2009-03-01; Completion date: 2010-01-01
Enrollment: 254 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the effects of commercially manufactured exenatide once weekly and exenatide BID in subjects whose type 2 diabetes is managed with diet and exercise alone or with oral antidiabetic medications. The study will examine glycemic control (as measured by HbA1C), safety, and tolerability.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: exenatide once weekly intervention 2: exenatide twice daily
Intervention descriptions: intervention 1: subcutaneous injection, 2.0mg, once a week intervention 2: subcutaneous injection; 5mcg (4 weeks) and 10mcg (20 weeks); twice a day

Protocol documents:
Clinical trial NCT00884325
Conditions: Atopic Dermatitis Pruritus
Keywords: Itching Atopic Dermatitis
Sponsor: Derm Research, PLLC
Start date: 2009-02-01; Completion date: 2010-01-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
It is historically well known that the management of pruritus in atopic dermatitis is very difficult. Most of the patients are not controlled with traditional antihistamines such as Clarinex, Claritin, and Allegra. It will be a welcome addition to our treatment armamentarium if a drug such as Xyzal can control pruritus associated with atopic dermatitis.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Levocetirizine dihydrochloride (Xyzal) intervention 2: placebo
Intervention descriptions: intervention 1: One tablet 5 mg taken orally at night for 28 days intervention 2: One tablet taken orally at night for 28 days

Protocol documents:
Clinical trial NCT00888940
Conditions: Bloodloss Surgical Procedures, Operative
Sponsor: Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Start date: 2009-06-01; Completion date: 2010-01-01
Enrollment: 243 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A Phase 2 Randomized Double-Blind Active-Controlled Study in Subjects Exposed to Cardio-pulmonary Bypass During Cardiac Surgery at High Risk of Bleeding

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Ecallantide intervention 2: Cyklokapron(R)
Intervention descriptions: intervention 1: 2.25 mg/L pump prime, 0.13 mg/kg loading dose, 2.25 mg/L constant infusion intervention 2: 1000-mg loading dose followed by a continuous infusion of 400 mg/hr with an additional 500 mg added to the pump prime

Protocol documents:
Clinical trial NCT00889226
Conditions: Hypercholesterolemia With Type2DM
Keywords: pitavastatin PWV ESPRIT Pitavastatin and Atorvastatin Adiponectin fasting insulin hs-CRP baPWV
Sponsor: JW Pharmaceutical
Start date: 2008-04-01; Completion date: 2010-01-01
Enrollment: 161 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A randomized, open label, dose titration study to evaluate the efficacy and safety of Pitavastatin compared to atorvastatin in Type 2 Diabetes Mellitus with hypercholesterolemia

Detailed description:
To evaluate the effect of pitavastatin compared to atorvastatin on the change of Lipid profiles, ApoA1, ApoB, adiponectin and baPWV as a marker of atherosclerosis in Type 2DM .

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pitavastatin intervention 2: Atorvastatin
Intervention descriptions: intervention 1: Drug: Pitavastatin 2mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 2mg daily for second 8wks No → 4mg daily for second 8wks intervention 2: Drug: Atorvastatin 10mg daily for 8wks after initial visit. After assessment of LDL-C \<100mg/dL at 8wks → Dose adjustment Yes → 10mg daily for second 8wks No → 20mg daily for second 8wks

Protocol documents:
Clinical trial NCT00894790
Conditions: Pain
Keywords: Treatment of the acute pain due to cervical sprain Celecoxib NSAID Diclofenac
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2009-11-01; Completion date: 2010-01-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This Study Will Evaluate Celecoxib Efficacy And Safety Versus Standard Doses Of Diclofenac In Acute Pain Due To Cervical Injury (Due To A Sprain) Related To A Motor Vehicle Accident

Detailed description:
On 21Oct2010 study was prematurely terminated due to poor enrollment with subsequent low number of participants. No safety or efficacy issues were involved in the decision to terminate prematurely.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Celecoxib intervention 2: oral Diclofenac
Intervention descriptions: intervention 1: celecoxib 200 mg BID (twice a day) with a loading dose of 400 mg intervention 2: diclofenac 75 mg tablet BID (twice a day)

Protocol documents:
Clinical trial NCT00901394
Conditions: Cardiovascular Abnormalities
Keywords: Nitrous oxide cobalamin homocysteine vitamin B12 folate No specific diseases targeted
Sponsor: Washington University School of Medicine
Start date: 2009-03-01; Completion date: 2010-01-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The goal of this study is to find out if giving intravenous B-vitamins before general anesthesia with nitrous oxide prevents the increase in homocysteine, a metabolite that has been linked to cardiovascular complications.

Detailed description:
Patients will be randomized into the following arms:

* Arm A: patients will receive N2O (60% N2O/40% O2) in an open-label fashion during surgery and vitamin supplementation (vitamin B12, 1 mg, and folate, 5 mg) before surgery.
* Arm B: patients will receive N2O 60% N2O/40% O2) in an open-label fashion during surgery and placebo before and after surgery.
* Arm C: patients will not receive N2O, vitamin supplementation, or placebo during/before surgery. Patients in this arm will not be randomized.

Patients will have blood drawn (total of 1-2 teaspoons over 3 days). We will take these samples before their surgery, when their surgery is completed, and in the morning of post-operative day 1. We will be checking their troponin I and troponin T, homocysteine, Vitamin B12, and folate levels. We will also perform a 12-lead EKG. Before and after surgery for patients in Arm A or B, will receive either vitamin B12 (1 mg) and folic acid (5 mg) (or placebo) added to their IV infusion. We also plan to use a non-invasive test known as a nerve conduction study to measure the function of their nerve system. Briefly, 2 small electrodes are attached to their skin over a nerve and, like an EKG, faint electrical pulses are generated and recorded. A typical nerve conduction measurement lasts about 10 minutes.

After the patients surgery we will do genetic testing of MTHFR genotype.

All study samples have been collected.

Of note: there were no secondary outcomes.

Arms: arm 1: B12-Folic acid, nitrous oxide arm 2: Nitrous oxide (NO) and placebo arm 3: oxygen nitrogen
Interventions: intervention 1: B12-Folic Acid, nitrous oxide intervention 2: Nitrous oxide (NO) and placebo intervention 3: Placebo intervention 4: oxygen nitrogen
Intervention descriptions: intervention 1: IV vitamin B12 (cyanocobalamin) 1 mg, single administration over 30 min.

IV folic acid, 5 mg, single administration over 30 min.

Both diluted in 250 ml normal saline. intervention 2: 60% nitrous oxide anesthesia plus saline intervention 3: Saline intervention 4: 60% air and oxygen mix.

Protocol documents:
Clinical trial NCT00905268
Conditions: Friedreich's Ataxia
Keywords: FRDA idebenone FRDA disease
Sponsor: Santhera Pharmaceuticals
Start date: 2006-04-01; Completion date: 2010-01-01
Enrollment: 232 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this trial is to study the efficacy, safety and tolerability of idebenone in 12 months of treatment in children and adults with Friedreich's Ataxia. This is a randomised placebo-controlled double-blind trial conducted in Europe. Efficacy outcomes include measures of neurological impairment and function, and measures of the heart.

Detailed description:
Idebenone, a short-chain analogue of Co-enzyme Q10 (CoQ10), has the potential to moderate underlying causes of Friedreich's Ataxia through its antioxidant activity and its role as an electron carrier in the respiratory chain promoting mitochondrial ATP production.

The current 12-month placebo-controlled treatment study in 232 patients aims to confirm the positive effect of idebenone on neurological function, as for instance observed in the recent 48-patient, 6-month NICOSIA study in children, using the International Cooperative Ataxia Rating Scale (ICARS) and the newly developed Friedreich's Ataxia Rating Scale (FARS).

In addition, the study aims to confirm the positive effect on cardiomyopathy associated with FRDA observed in several small studies. Cardiac anatomy and function will be assessed using echocardiography, tissue Doppler imaging and cardiac MRI methods in patients with FRDA cardiomyopathy. In addition exercise capacity, measured as peak workload, will be assessed in patients able to comply with a modified exercise protocol.

Arms: arm 1: Patients under/equal 45 kg: idebenone 180 mg/day Patients over 45 kg: idebenone 360 mg/day arm 2: Patients under/equal 45 kg: idebenone 450 mg/day Patients over 45 kg: idebenone 900 mg/day arm 3: Patients under/equal 45 kg: idebenone 1350 mg/day Patients over 45 kg: idebenone 2250 mg/day arm 4: placebo
Interventions: intervention 1: idebenone intervention 2: Placebo
Intervention descriptions: intervention 1: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals. intervention 2: 12 months of 1 of 3 treatments arms of oral idebenone or placebo.Treatment taken 3 times daily with meals.

Protocol documents:
Clinical trial NCT00907803
Conditions: Orthopoxviral Disease
Keywords: Orthopoxvirus Smallpox This is a safety study only ST-246 is being studied for treatment of Orthopoxviruses
Sponsor: SIGA Technologies
Start date: 2009-06-01; Completion date: 2010-01-01
Enrollment: 107 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study was to assess the safety, tolerability, and pharmacokinetics of two clinical doses of the anti-orthopoxvirus drug, ST-246, administered as a single daily oral dose for 14 days to healthy, fed volunteers. The results of this trial determine which dose will be used in expanded pivotal safety trials.

Detailed description:
This study is a Phase II, double-blind, randomized, placebo-controlled, multi-center (3 sites) trial to assess the safety, tolerability, and pharmacokinetics of 400 mg and 600 mg Form I ST-246 when administered as a single daily oral dose for 14 days to 107 healthy, fed volunteers between 18 and 74 years of age. Safety parameters included adverse events, vital signs, physical examinations, laboratory tests (hematology, blood chemistry, and urinalysis) and electrocardiograms.

Arms: arm 1: ST-246 400mg (2 x 200 mg Capsules) Orally Once Daily for 14 days arm 2: ST-246 600 mg (3 x 200 mg Capsules) Orally Once Daily for 14 days arm 3: Matching Placebo capsules, Orally Once Daily for 14 days
Interventions: intervention 1: ST-246 400 mg intervention 2: ST-246 600 mg intervention 3: Placebo
Intervention descriptions: intervention 1: Capsules, 400 mg daily for 14 days intervention 2: Capsules, 600 mg daily for 14 days intervention 3: Capsules, once daily for 14 days

Protocol documents:
Clinical trial NCT00909324
Conditions: Dry Eye
Keywords: Post LASIK dry eye Pre LASIK dry eye Hypromellose
Sponsor: Novartis Pharmaceuticals
Start date: 2009-08-01; Completion date: 2010-01-01
Enrollment: 170 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to assess the tolerability and comfort of peri-operative 0.3% hypromellose eye drops in LASIK surgery patients and to assess whether pre-operative 0.3% hypromellose eye drops add to post-operative comfort in LASIK surgery patients compared to control (no pre-operative lubricant).

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pre-LASIK 0.3% hypromellose intervention 2: Post-LASIK 0.3% hypromellose
Intervention descriptions: intervention 1: Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting 5 days prior to LASIK surgery and continuing through 1 month after LASIK surgery. intervention 2: Patients self-administered GenTeal eye drops qid (quarter in die, 4 times a day) starting on the day of LASIK surgery and continuing through 1 month after surgery.

Protocol documents:
Clinical trial NCT00911586
Conditions: Male Hypogonadism Primary Hypogonadism Secondary Hypogonadism
Sponsor: Clarus Therapeutics, Inc.
Start date: 2009-07-01; Completion date: 2010-01-01
Enrollment: 15 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to confirm how long (i.e., how many days) it takes to reach steady-state when testosterone undecanoate is administered twice daily.

Detailed description:
Serum testosterone levels will be obtained in hypogonadal (serum testosterone \<300 ng/dL) males receiving testosterone undecanoate capsules administered twice daily. Serum samples will be obtained consecutively in the morning on several days during one month of open-label treatment to confirm the time at which steady-state is reached.

Arms: arm 1: Oral testosterone undecanoate, 200 mg testosterone (T) as TU, twice daily for 28 days.
Interventions: intervention 1: Testosterone undecanoate
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00928421
Conditions: Varicose Veins
Keywords: Varicose Veins
Sponsor: Boston Scientific Corporation
Start date: 2009-06-01; Completion date: 2010-01-01
Enrollment: 16 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the effect and safety of Varisolve® 0.125% \[0.2%\]

Detailed description:
In patients with SFJ incompetence due to reflux of the Great Saphenous Vein (GSV) or major accessory veins, with venous disease manifested by both symptoms and visible varicosities: using duplex ultrasonography, to evaluate the efficacy of Varisolve® 0.125% \[0.2%\] as assessed by the elimination of SFJ reflux and/or occlusion of the treated vein

Arms: arm 1: None
Interventions: intervention 1: Polidocanol Endovenous Microfoam 0.125%
Intervention descriptions: intervention 1: Polidocanol Endovenous Microfoam 0.125%, single dose

Protocol documents: