ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01606735
Conditions: Inflammation Associated With Cataract Surgery
Keywords: cataract surgery ocular inflammation
Sponsor: ICON Bioscience Inc
Start date: 2012-04-01; Completion date: 2013-03-01
Enrollment: 172 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will test the efficacy and safety of IBI-10090 in the treatment of ocular inflammation after ocular surgery.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None
Interventions: intervention 1: IBI-10090
Intervention descriptions: intervention 1: dexamethasone

Protocol documents:
Clinical trial NCT01607320
Conditions: Polycystic Ovarian Syndrome
Keywords: PCOS Infertility Anovulation
Sponsor: Bruce Lessey
Start date: 2012-06-01; Completion date: 2013-03-01
Enrollment: 3 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study examines Raloxifene versus Clomiphene to induce ovulation in women with polycystic ovarian syndrome (PCOS).

Detailed description:
Clomiphene citrate (CC) is the major pharmaceutical treatment of anovulation in polycystic ovary syndrome, used for over 40 years. Despite the vast experience using this drug, the pregnancy rates associated with its use are low and recent large studies from Australia regarding birth defects suggest that CC may be associated with birth defects. Alternatives to CC are limited. Another selective estrogen receptor modulator, Raloxifene (RAL) does not have the long half life exhibited by CC, and has recently been shown to be equivalent to CC in terms of ability to induce ovulation in PCOS women. In addition, prior studies have demonstrated potential benefits on markers of uterine receptivity in a cell line model by blocking estrogen activity. Beyond this, there are no studies to examine whether Raloxifene is an effective oral agent for the treatment of women desiring pregnancy, but the investigators' hypothesis is that Raloxifene will work as well as CC but be better at establishment and maintenance of pregnancy than CC

Arms: arm 1: 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 arm 2: 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7
Interventions: intervention 1: Raloxifene intervention 2: Clomiphene
Intervention descriptions: intervention 1: Thirty PCOS patients treated with 3 cycles of 120mg/day of Evista (raloxifene) on days 3 to 7 following an initial provera withdrawal intervention 2: Thirty PCOS patients treated with 3 cycles of 100mg/day of Clomid (clomiphene citrate) on days 3 to 7 following an initial provera withdrawal

Protocol documents:
Clinical trial NCT01607554
Conditions: Non-small Cell Lung Cancer
Keywords: Lung non small cell NSCLC Irinotecan
Sponsor: New Mexico Cancer Research Alliance
Start date: 2012-04-01; Completion date: 2013-03-01
Enrollment: 2 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Certain genetic factors can affect a patient's potential sensitivity to therapeutic drugs and other agents. There is a factor called ISG15 which might help doctors better identify patients with advanced non-small cell lung cancer (NSCLC) whose tumors may be more sensitive to the drug called Irinotecan. This factor is elevated in roughly 30% of NSCLC cases. Irinotecan is an agent that inhibits the enzyme called topoisomerase I that is involved in cell growth, and it has been FDA approved for 17 years for another type of cancer.

Detailed description:
The goal of this trial is to demonstrate the potential clinical benefit of targeted irinotecan chemotherapy in NSCLC patients whose tumors display a specific phenotype that is associated with increased sensitivity to this drug, ISG15H.

Arms: arm 1: The starting dose of irinotecan for the study is 180 mg/m2, given intravenously every 14 days. Each 14 day period will constitute one cycle of treatment.
Interventions: intervention 1: Irinotecan
Intervention descriptions: intervention 1: 180 mg/m2 Irinotecan intravenously over 60 minutes on day 1 of each cycle

Pre-medication for irinotecan: palonosetron 0.25 mg and dexamethasone 8 - 16 mg, both administered intravenously. Atropine 0.25 - 0.5 mg subcutaneously or IV is at the discretion of the treating physician

Protocol documents:
Clinical trial NCT01626391
Conditions: Alzheimer's Disease
Keywords: Alzheimer's Disease TRx0237 Safety Study AD
Sponsor: TauRx Therapeutics Ltd
Start date: 2012-09-01; Completion date: 2013-03-01
Enrollment: 9 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary purpose of this study is to assess the safety and tolerability of TRx0237 when taken at the same time as acetylcholinesterase inhibitors (i.e., donepezil, galantamine, or rivastigmine) and / or memantine to treat patients with mild to moderate Alzheimer's Disease.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: TRx0237 intervention 2: Placebo
Intervention descriptions: intervention 1: TRx0237 tablets 250 mg/day (given as 125 mg bid) for 4 weeks intervention 2: Placebo tablets will be administered twice daily (b.i.d.) for 4 weeks. The placebo tablets include 4 mg of TRx0237 as a urinary and faecal colourant to maintain blinding; hence, the placebo group will receive a total of 8 mg/day of TRx0237.

Protocol documents:
Clinical trial NCT01644734
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2011-11-01; Completion date: 2013-03-01
Enrollment: 1328 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To evaluate the early (3-month) impact of the long-acting anticholinergic Spiriva HH maintenance treatment on the COPD symptoms using the novel COPD Assessment test (CAT) in the real life setting of COPD patients, previously treated with short-acting bronchodilator on regular or as-needed basis.

Detailed description:

Interventions: intervention 1: Spiriva HandiHaler
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01671085
Conditions: Healthy Volunteers Hypercholesterolemia
Sponsor: Eli Lilly and Company
Start date: 2012-08-01; Completion date: 2013-03-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a study in healthy participants with high levels of "bad" cholesterol who are already taking a popular type of cholesterol-lowering medication called statins. Following multiple doses of LY3015014, investigators will study the safety and tolerability of the drug, how the body handles the drug, and the drug's effect on the body. Participants will remain in the study for about 3 months, not including screening. Screening is required within 28 days before the study starts.

Detailed description:

Arms: arm 1: 1.0 mg/kg of LY3015014 given subcutaneously (SQ) on 2 dosing occasions occurring 4 weeks apart (Q4W) (Days 1 and 29). arm 2: 0.9% sodium chloride injection given SQ (to match LY3015014) on 2 dosing occasions Q4W (Days 1 and 29).
Interventions: intervention 1: LY3015014 intervention 2: Placebo
Intervention descriptions: intervention 1: Administered SQ intervention 2: Administered SQ

Protocol documents:
Clinical trial NCT01700985
Conditions: Psoriasis Plaque Psoriasis
Keywords: psoriasis plaque psoriasis 122-0551 steroid
Sponsor: Therapeutics, Inc.
Start date: 2012-05-01; Completion date: 2013-03-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Corticosteroids are one of the mainstays of treatment for subjects with corticosteroid-responsive dermatoses such as psoriasis. This study has been designed to determine and compare the efficacy and safety of a formulation of 122-0551 versus the corresponding Vehicle in subjects with stable plaque psoriasis after twice daily dosing for 14 consecutive days.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: 122-0551 intervention 2: Vehicle
Intervention descriptions: intervention 1: Applied twice daily for two weeks intervention 2: Applied twice daily for two weeks

Protocol documents:
Clinical trial NCT01703845
Conditions: Pulmonary Disease, Chronic Obstructive
Sponsor: Boehringer Ingelheim
Start date: 2012-10-01; Completion date: 2013-03-01
Enrollment: 32 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The primary objective of this study is to assess pharmacokinetics of tiotropium + olodaterol fixed-dose combination (2.5 µg/ 5 µg, 5 µg/ 5 µg) delivered by the RESPIMAT inhaler after 3 weeks once daily treatment in Japanese patients with COPD.

Detailed description:

Arms: arm 1: Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT arm 2: Tiotropium and Olodaterol fixed dose combination (FDC) solution for inhalation - RESPIMAT
Interventions: intervention 1: Tiotropium (high dose) + Olodaterol intervention 2: Tiotropium (low dose) + Olodaterol
Intervention descriptions: intervention 1: Tiotropium + Olodaterol solution for inhalation intervention 2: Tiotropium + Olodaterol solution for inhalation

Protocol documents:
Clinical trial NCT01711177
Conditions: Primary Open Angle Glaucoma
Keywords: primary open angle glaucoma retinal oximetry
Sponsor: Université de Montréal
Start date: 2012-10-01; Completion date: 2013-03-01
Enrollment: 14 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Glaucoma is the second leading cause of blindness among seniors in Canada. It is often associated with an elevated intraocular pressure (IOP), but its exact mechanism is still largely unknown. Some studies have shown a link between glaucoma and changes in the amount of oxygen in the veins of the eye. The study aims to compare the amount of oxygen in ocular veins among three different groups using a spectrophotometer. This instrument is linked to a camera and can measure the quantity of oxygen in the veins using different characteristics of the blood inside.

The groups of the study are: patients without glaucoma, patients suspected of glaucoma and patients newly diagnosed with glaucoma. The drug the investigators are using, Travoprost 0.004%, will only be administered to the groups suspected or diagnosed with glaucoma. Travoprost 0.004% is already approved for use in Quebec and is part of standard care. Ten patients will be recruited into each group for a total of 30 patients in this study. All patients for the suspected or diagnosed groups will be recruited from the Jewish General Hospital. Subsequently all testing will be done at the École d'optométrie, Université de Montréal

Detailed description:

Arms: arm 1: Normal patient placebo arm 2: Patients with elevated Intraocular pressure higher than 18 mmHg (placebo) arm 3: Treated with Travoprost (0.04%)
Interventions: intervention 1: placebo intervention 2: travoprost
Intervention descriptions: intervention 1: Placebo intervention 2: Travatan Z is administered to newly diagnosed glaucoma patient

Protocol documents:
Clinical trial NCT01711866
Conditions: Advanced Idiopathic Parkinson's Disease
Keywords: Rotigotine Neupro Switch Dopamine agonists
Sponsor: UCB BIOSCIENCES GmbH
Start date: 2012-09-01; Completion date: 2013-03-01
Enrollment: 87 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the safety and feasibility of switching subjects with advanced Parkinson's Disease (PD) from Pramipexole or Ropinirole to Rotigotine and to assess the effects of Rotigotine on motor and non-motor symptoms of Parkinson's Disease in subjects switched from previous treatment with either Pramipexole or Ropinirole.

Detailed description:

Arms: arm 1: First application of Rotigotine patch for 24 hours on Day 1, followed by application of a new patch each day of the Treatment Period.

* Subjects on lower doses switch from Pramipexole or Ropinirole to equivalence doses of Rotigotine on Day 1 of the 28 days Treatment Period. On Day 8 (Visit 3) the dose will be evaluated and potentially adjusted up to a maximum dose of 8 mg / 24 hours.
* Subjects on higher doses switch from the equivalent dose to 8 mg / 24 hours Rotigotine of Pramipexole or Ropinirole to 8 mg / 24 hours Rotigotine on Day 1 and the remainder of the dose of Pramipexole or Ropinirole is to be switched on Day 8 of the 28 days Treatment Period. On Day 15 (Visit 4) the dose will be evaluated and potentially adjusted up to a maximum dose of 16 mg / 24 hours.
Interventions: intervention 1: Rotigotine
Intervention descriptions: intervention 1: Rotigotine up to 16 mg / 24 hours, 4 weeks.

Protocol documents:
Clinical trial NCT01712711
Conditions: Non-alcoholic Fatty Liver Disease
Keywords: Steatohepatitis, Helicobacter pylori, Insulin resistance, Alanine aminotransferase, Aspartate aminotransferase,
Sponsor: Tehran University of Medical Sciences
Start date: 2012-09-01; Completion date: 2013-03-01
Enrollment: 40 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of study was to evaluate the effect of helicobacter pylori eradication on liver fat content, liver function tests, lipid profile, homeostasis model assessment-IR (HOMA-IR) index, and anthropometric measurements (body mass index and waist circumference)in diabetic subjects with non-alcoholic fatty liver disease.

Detailed description:
Helicobacter pylori (HP) antigens have been found in the liver of individuals with benign and malignant liver diseases. The role of HP in the pathogenesis of non-alcoholic fatty liver disease (NAFLD) is controversial.

This randomized double blind clinical trial was performed in diabetic dyspeptic patients with positive antibody to HP and the evidence of fatty liver in ultrasonography. After excluding other causes, participants with persistent elevated serum aminotransferase levels were presumed to have NAFLD. Those with NAFLD liver fat score greater than (-0.64) and positive urea breath test (UBT) were enrolled. They were randomly assigned to lifestyle modification alone or lifestyle modification plus HP eradication groups. Quadruple therapy (omeprazole, amoxicillin, bismuth subcitrate, and clarithromycin) for HP eradication was performed in two weeks. HP eradication was documented by UBT. Liver fat content, fasting serum glucose, alanine aminotransferase, aspartate aminotransferase, alkaline phosphatase, triglyceride, cholesterol, high and low-density lipoprotein, HOMA-IR, and anthropometric measurements (body mass index and waist circumference) were checked at baseline and six weeks post-treatment.

Arms: arm 1: Obtaining ideal body weight by calorie restriction diet and programmed physical activity arm 2: H.pylori eradication by quadruple antibiotic therapy for two weeks plus obtaining ideal body weight by calorie restriction diet and programmed physical activity
Interventions: intervention 1: H.pylori eradication
Intervention descriptions: intervention 1: The regimen consists of Omeprazole (20 mg/BD)+ Amoxicillin (1 g/day)+ Bismuth subcitrate (240 mg/BD)+ Azithromycin (500 mg/BD)for two weeks

Protocol documents:
Clinical trial NCT01714544
Conditions: Psoriasis
Sponsor: Promius Pharma, LLC
Start date: 2012-10-01; Completion date: 2013-03-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to determine whether Cloderm Cream is effective for topical treatment of moderate psoriasis over 28 days.

Detailed description:
The objective of this study is to estimate the efficacy of Cloderm Cream for topical treatment of moderate plaque psoriasis over 28 days using current standards for evaluation.

Arms: arm 1: Cloderm (clocortolone pivalate) Cream 0.1%, twice daily for 28 days
Interventions: intervention 1: Cloderm Cream
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT01716221
Conditions: Friedreich Ataxia
Sponsor: University of Colorado, Denver
Start date: 2012-10-01; Completion date: 2013-03-01
Enrollment: 1 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to document the clinical effects of bupropion and citalopram in a single subject with Friedreich Ataxia.

Detailed description:
This is a double blind study with a single subject to objectively document the clinical effects of bupropion and citalopram in a single patient with Friedreich Ataxia (FA), whose disorder symptoms have improved with the use of these medications.

Arms: arm 1: 100mg Bupropion \& 20mg Citalopram taken orally one time per day or 100mg Bupropion \& 10mg Citalopram taken orally one time per day or 50mg Bupropion \& 20mg Citalopram taken orally one time per day 0r 50mg Bupropion \& 10mg Citalopram taken orally one time per day arm 2: 100mg Bupropion \& Placebo taken orally one time per day or 50mg Bupropion \& Placebo taken orally one time per day arm 3: Placebo \& 20mg Citalopram taken orally one time per day or Placebo \& 10mg Citalopram taken orally one time per day arm 4: Placebo \& Placebo taken orally one time per day
Interventions: intervention 1: bupropion & Citalopram intervention 2: Bupropion & Placebo intervention 3: Placebo & Citalopram intervention 4: Placebo & Placebo
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None intervention 4: None

Protocol documents:
Clinical trial NCT01726270
Conditions: Lower Urinary Tract Symptoms
Sponsor: Boehringer Ingelheim
Start date: 2012-11-01; Completion date: 2013-03-01
Enrollment: 689 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Multicenter trial conducted in Pharmacy retail centers

Detailed description:

Arms: arm 1: patients will take drug for 8 weeks in this exploratory study
Interventions: intervention 1: tamsulosin
Intervention descriptions: intervention 1: 0.4 mg

Protocol documents:
Clinical trial NCT01734889
Conditions: Hereditary Tyrosinemia, Type I
Keywords: nitisinone Orfadin suspension taste acceptability
Sponsor: Swedish Orphan Biovitrum
Start date: 2012-10-01; Completion date: 2013-03-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to verify that pediatric patients, especially those who are not old enough to swallow capsules, accept the taste and palatability of a new suspension.

Detailed description:
This is an open, non-randomized, non-controlled, multiple-dose study in 18 pediatric patients. The treatment period is three days, and during the study the subjects will rate the taste and palatability of the suspension or (for younger children) their parents will rate the child´s acceptance of the suspension.

The study consists of a screening period, a 3 day treatment period and a 1 week follow-up period.

Arms: arm 1: Drug: nitisinone, oral suspension
Interventions: intervention 1: Nitisinone
Intervention descriptions: intervention 1: Oral suspension

Protocol documents:
Clinical trial NCT01737996
Conditions: Healthy
Sponsor: Boehringer Ingelheim
Start date: 2012-11-01; Completion date: 2013-03-01
Enrollment: 32 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The objective of the current trial is to evaluate safety, tolerability and pharmacokinetics of different multiple doses of BI 207127 BID and multiple doses of BI 207127 combined with faldaprevir in healthy male and female subjects.

Detailed description:

Arms: arm 1: For the first 9 days patients receive BI 207127 low dose or high dose, then BI 207127 high dose with faldaprevir
Interventions: intervention 1: BI 207127 + faldaprevir
Intervention descriptions: intervention 1: fixed dose combination

Protocol documents:
Clinical trial NCT01746017
Conditions: Diabetes Mellitus, Type 2
Sponsor: Eli Lilly and Company
Start date: 2012-12-01; Completion date: 2013-03-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of this trial is to evaluate the safety of the study drug in healthy participant and participant with diabetes. It will investigate how much of the study drug gets into the blood stream and how long it takes the body to get rid of it. Information about any side effects that may occur will also be collected.

The study consists of two parts. Part A will study healthy participants in up to 4 dosing periods over approximately 6 weeks. Part B will study participants with diabetes in up to 3 dosing periods over approximately 5 weeks.

Detailed description:

Arms: arm 1: Single oral dose of placebo administered to healthy participants in up to 1 of 4 study periods in Part A arm 2: Single ascending dose of LY2922470 \[starting at 1 milligram (mg)\] administered orally to healthy participants in up to 3 of 4 study periods in Part A arm 3: Single oral dose of placebo administered to participants with type 2 diabetes mellitus (T2DM) in up to 1 of 3 study periods in Part B arm 4: Single ascending dose of LY2922470 administered orally to participants with T2DM in up to 2 of 3 study periods in Part B. Dose determined by Part A
Interventions: intervention 1: Placebo intervention 2: LY2922470
Intervention descriptions: intervention 1: Administered orally as capsules intervention 2: Administered orally as capsules

Protocol documents:
Clinical trial NCT01746745
Conditions: Healthy Volunteers
Sponsor: Eli Lilly and Company
Start date: 2013-01-01; Completion date: 2013-03-01
Enrollment: 6 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is a single dose study of radiolabelled LY2940680 taken by mouth in healthy participants to study how the body absorbs and removes LY2940680 from the blood. This study is for research purposes only and is not intended to treat any medical condition.

Detailed description:

Arms: arm 1: Single 100 milligram (mg) dose of LY2940680 containing 100 microCuries of carbon-14-labeled LY2940680 (\[\^14C\]-LY2940680)
Interventions: intervention 1: [^14C]-LY2940680
Intervention descriptions: intervention 1: Administered as solution by mouth

Protocol documents:
Clinical trial NCT01751178
Conditions: Gingivitis
Sponsor: GlaxoSmithKline
Start date: 2012-10-01; Completion date: 2013-03-01
Enrollment: 324 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The aim of this study is to compare subject gingival health after 6 weeks of twice daily use of a non-alcohol or alcohol containing mouthrinse and brushing compared to brushing only.

Detailed description:

Arms: arm 1: rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash with alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute. arm 2: rinse with 10ml 0.2% w/v Chlorhexidine Digluconate Mouthwash without alcohol for 1 timed minute twice daily for 6 weeks following brushing with a full brush head of standard toothpaste for 1 timed minute.
Interventions: intervention 1: Chlorhexidine Digluconate Mouthwash with Alcohol intervention 2: Chlorhexidine Digluconate Mouthwash without Alcohol
Intervention descriptions: intervention 1: 0.2% w/v Chlorhexidine Digluconate, alcohol containing - UK Marketed Mouthwash intervention 2: 0.2% w/v Chlorhexidine Digluconate, without alcohol - UK Marketed Mouthwash

Protocol documents: