ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01122160
Conditions: Anthocyanin Metabolism
Keywords: anthocyanin omeprazole Prilosec gastric pH proton pump inhibitor PPI nutrition
Sponsor: USDA Beltsville Human Nutrition Research Center
Start date: 2010-05-01; Completion date: 2010-12-01
Enrollment: 13 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Anthocyanins are phytonutrients that provide blue, purple and red colors to fruits and vegetables. The purpose of the study is to determine whether absorption of anthocyanins occurs in the acid pH of the stomach and to determine whether altering stomach pH by use of an over-the-counter medicine, Prilosec TM, alters absorption of anthocyanins from strawberries and blackberries.

Detailed description:

Arms: arm 1: Placebo with berries (blackberries + strawberries) arm 2: Prilosec (omeprazole) 20.6 mg tablet with berries (blackberries + strawberries)
Interventions: intervention 1: omeprazole intervention 2: placebo
Intervention descriptions: intervention 1: omeprazole 20.6 mg tablet with berries (blackberries + strawberries) intervention 2: Placebo with berries (blackberries + strawberries)

Protocol documents:
Clinical trial NCT01124604
Conditions: Pain Low Back Pain Back Pain Osteoarthritis, Knee
Keywords: Pain Low Back Pain Back Pain Osteoarthritis, Knee Tapentadol Tapentadol Hydrochloride Extended Release
Sponsor: Janssen Pharmaceutical K.K.
Start date: 2010-04-01; Completion date: 2010-12-01
Enrollment: 91 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and to explore the pharmacokinetics (how drugs are absorbed in the body, how they are distributed within the body and how they are removed from the body over time) of tapentadol hydrochloride extended release (ER) tablets in Japanese participants with moderate to severe chronic pain due to osteoarthritis (disorder in which the joints become painful and stiff) of knee or low back pain.

Detailed description:
This is a randomized (study drug assigned by chance), multi-center (when more than one hospital or medical school team works on a medical research study), double-blind (neither physician nor participant knows the name of the assigned drug), placebo-control (participants are randomly assigned to a test treatment or to an identical-appearing treatment that does not contain the test drug), parallel-group (each group of participants will be treated at the same time) comparison study in participants with chronic pain due to osteoarthritis of knee or low back pain. The study duration will be of 14 weeks, which consists of a screening period of 1 week during which the participants will be evaluated for study eligibility, a treatment period of 12 weeks and a follow-up period of 1 week. The treatment period will consist of titration period (from the initiation of the study treatment to determination of the individual's maintenance dose) and maintenance period (from completion of the titration period to the completion of the treatment period). An optimal dose (maintenance dose) will be determined for each participant during the titration period and the treatment will be continued at the maintenance dose to assess the efficacy and safety. Tapentadol hydrochloride ER tablets 25 to 250 milligram or placebo will be administered orally twice daily. Efficacy and safety of the participants will primarily be evaluated by change from baseline in average pain intensity score based on 11-point Numerical Rating Scale (NRS) and Clinical Opiate Withdrawal Scale (COWS), respectively. Participants' safety will be monitored throughout the study.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tapentadol Hydrochloride intervention 2: Placebo
Intervention descriptions: intervention 1: Tapentadol hydrochloride extended release (ER) tablets 25 to 250 milligram (mg) will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion. intervention 2: Placebo matched to tapentadol hydrochloride ER tablets 25 to 250 mg will be administered orally twice daily for 12 weeks. Dose will be adjusted as per Investigator's discretion.

Protocol documents:
Clinical trial NCT01126424
Conditions: Cognition
Keywords: Anti-muscarinics Anti-cholinergics Cognition Solifenacin
Sponsor: Astellas Pharma Inc
Start date: 2010-04-01; Completion date: 2010-12-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose is to compare solifenacin and oxybutynin with an inactive tablet and assess any potential effects on mental ability.

Detailed description:
All subjects will receive each intervention during the course of the study. Subjects will complete a 21-day washout period between treatment periods and following last treatment period.

Arms: arm 1: Participants received 21 days of treatment with 5 mg solifenacin, in tablet form once a day. arm 2: Participants received 21 days of treatment with 10 mg oxybutynin (1 x 5 mg twice daily) in capsule form. arm 3: Participants received 21 days of treatment with placebo.
Interventions: intervention 1: Solifenacin intervention 2: Oxybutynin intervention 3: Placebo
Intervention descriptions: intervention 1: tablet intervention 2: capsule intervention 3: tablet

Protocol documents:
Clinical trial NCT01129778
Conditions: Barrett Esophagus Gastroesophageal Reflux
Sponsor: Stanford University
Start date: 2009-11-01; Completion date: 2010-12-01
Enrollment: 27 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this research study is to assess how safe, effective (how well it works), and tolerable (to put up with) the drug Zegerid is in reducing reflux episodes in patients who have both gastroesophageal reflux disease (GERD) and Barrett's esophagus. Zegerid has been approved by the US Food and Drug Administration (FDA) for the treatment of GERD. The investigators hope to learn the effectiveness of Zegerid for reducing the amount of acid reflux patients are experiencing in the esophagus (swallowing pipe).

Detailed description:
The following procedures will be performed at the Screening Visit:

* Obtain informed consent.
* Obtain information about your age and gender.
* Evaluate whether you qualify for the study.
* Document prior negative testing for H. pylori infection (a bacterial infection in the stomach that can cause ulcers) including the date of testing.
* Make sure that you have not used any investigational medications or participated in a clinical trial in the 30 days prior to the Screening Visit.
* Obtain medical history.
* Record medication history (including concomitant medications).
* Obtain vital signs.
* Conduct a physical examination.
* If a Bravo pH study has not been done within 8 weeks, instruct the patient to discontinue their medication for GERD during the 7-10 day washout period.
* Instruct the patient to discontinue the use of all prohibited medications during the applicable time intervals and not to start any new concomitant medications during the trial.
* Distribute Gelusil tablets to be used as "rescue medication"; instruct the patient that no more than 6 Gelusil tablets per day or 21 tablets over any 7-day interval will be allowed.
* Schedule the patient to return for the Qualification Visit, or for pH monitoring and the Qualification Visit. Only patients with abnormal pH monitoring will be able to enter the treatment period.

Procedures that will occur during the Treatment Period:

* You will receive Zegerid 1 hour before breakfast and at bedtime for at least 14 days and no longer than 28 days
* At the end of the Zegerid treatment period, you will undergo 48-hour Bravo pH monitoring on Zegerid therapy for two days. You will complete a symptom survey and quality of life survey after the completion of the pH study.

Arms: arm 1: Administered Ome-NaBic 40 mg orally 1 h before breakfast and bedtime
Interventions: intervention 1: Zegerid (proton pump inhibitor) intervention 2: Bravo pH monitoring
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT01139190
Conditions: Gastroduodenal Ulcerations Erosion
Keywords: NSAID-induced gastroduodenal ulcerations or erosion
Sponsor: PLx Pharma
Start date: 2010-07-01; Completion date: 2010-12-01
Enrollment: 77 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the subchronic gastrointestinal (GI) safety of PL3100 versus Naproxen in normal healthy volunteers.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: PL3100 intervention 2: Naproxen
Intervention descriptions: intervention 1: Oral administration intervention 2: Oral administration

Protocol documents:
Clinical trial NCT01139580
Conditions: Psoriasis
Keywords: Plaque Psoriasis Psoriasis
Sponsor: Stiefel, a GSK Company
Start date: 2010-05-01; Completion date: 2010-12-01
Enrollment: 363 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine the safety and effectiveness in the treatment of psoriasis on the scalp and on the body.

Detailed description:
The study subjects must have moderate psoriasis of the body and scalp with an ISGA of 3 at baseline. In addition, the subjects must have an evaluable target lesion of at least 2 cm² on the body with a score of 2 or 3 for erythema, scaling and plaque. All subjects will apply Calcipotriene Foam, 0.005% or vehicle foam topically twice a day (am and pm) to all psoriatic lesions on the body and scalp. Study visits will occur at baseline (day 1) and at weeks 1, 2, 4, and 8.

Arms: arm 1: Calcipotriene Foam 0.005%, arm 2: Vehicle Foam
Interventions: intervention 1: Calcipotriene Foam intervention 2: Vehicle Foam
Intervention descriptions: intervention 1: Calcipotriene Foam 0.005%. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group intervention 2: Vehicle Foam. All treatments will be administered to the skin twice daily (am-pm) for 8 weeks for subjects in this group

Protocol documents:
Clinical trial NCT01148693
Conditions: Cholangitis
Keywords: Cholangitis; Cholangiopancreatography, Endoscopic Retrograde; stents; cholestasis
Sponsor: Tehran University of Medical Sciences
Start date: 2009-12-01; Completion date: 2010-12-01
Enrollment: 114 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Cholangitis is the most prevalent infectious complication of ERCP. Stenting of biliary strictures and stenosis is one of important risk factors for post-ERCP cholangitis. Adding antibiotics to contrast media has proposed in some studies for prevention of cholangitis but remains controversial. In this study we compare effect of adding gentamicin versus placebo in preventing cholangitis in patients who undergone endoscopic stenting for non-calculus strictures and stenosis.

Detailed description:

Arms: arm 1: adding 10mg gentamicin to every 10 ml of contrast media arm 2: Identical placebo
Interventions: intervention 1: gentamicin intervention 2: Placebo
Intervention descriptions: intervention 1: 10mg per 10ml of contrast media intervention 2: Distilled water

Protocol documents:
Clinical trial NCT01154764
Conditions: Healthy
Keywords: healthy male volunteers
Sponsor: CrystalGenomics, Inc.
Start date: 2009-10-01; Completion date: 2010-12-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a Phase I, open-labeled, randomization and 2x2 Cross trial to compare the pharmacokinetic effects between ketoconazole and CG100649 for healthy male volunteers.

Detailed description:
* Adverse Events The whole study discontinuation is determined based on the following criteria with Adverse Events classified using US NCI (National Cancer Institute) 'Common Terminology Criteria for Adverse Events (CTCAE)
* Pharmacokinetic assessment Real sampling times will be used to calculate pharmacokinetic parameters. Concentrations below the lower limit of quantification, samplings which are not applicable, or missing data will be substituted by "\<LLOQ", "NA", or "MD" respectively. Pharmacokinetic analyses will be performed on CG100649 only.

Arms: arm 1: Period 1: CG100649 will be administered alone on Day 1 -After washout period- Period 2: The combination of CG100649 and ketoconazole tabs together on Day 1 followed by ketoconzzole tabs arm 2: Period 1: The combination of CG100649 and ketoconazole tabs will be administered together on Day 1, followed by ketoconazole tabs for 4 days, for a total of 5 days.

-After washout period- Period 2: CG100649 alone
Interventions: intervention 1: CG100649 intervention 2: Ketoconazole
Intervention descriptions: intervention 1: I period: CG 100649 II period: Ketoconalzole + CG100649 at the same time intervention 2: I period: ketoconazole + CG100649 II period: CG 100649

Protocol documents:
Clinical trial NCT01156012
Conditions: Glaucoma
Sponsor: Laboratoires Thea
Start date: 2009-09-01; Completion date: 2010-12-01
Enrollment: 404 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to assess the efficacy and safety of T2345 versus active comparator.

Detailed description:

Arms: arm 1: One drop of T2345 arm 2: One drop
Interventions: intervention 1: T2345 intervention 2: Prostaglandin
Intervention descriptions: intervention 1: One drop of T2345 intervention 2: One drop

Protocol documents:
Clinical trial NCT01165424
Conditions: Rhinitis, Allergic, Perennial
Sponsor: Organon and Co
Start date: 2010-04-01; Completion date: 2010-12-01
Enrollment: 80 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric subjects (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Subjects (subject's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.

Detailed description:

Arms: arm 1: MFNS 50 μg spray device. The dose will be as follows:

* 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.
Interventions: intervention 1: mometasone furoate
Intervention descriptions: intervention 1: MFNS 50 μg spray device

* 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning.
* 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning.

Protocol documents:
Clinical trial NCT01167426
Conditions: Multiple Sclerosis
Keywords: Relapsing Remitting Multiple Sclerosis RRMS Clinically Isolated Syndrome CIS Copaxone glatiramer acetate Autoject 2
Sponsor: Teva Neuroscience, Inc.
Start date: 2010-07-01; Completion date: 2010-12-01
Enrollment: 148 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multicenter study conducted at approximately 20 sites. Each patient will inject GA daily for 6 weeks utilizing an autoject 2 device to determine overall injection satisfaction.

Detailed description:
The study will consist of a 2 week treatment period with participants injecting their current therapy of Copaxone 20 mg/1.0 mL glatiramer acetate utilizing an autoject 2. All participants will then roll over to the new formulation of 20 mg/0.5 mL glatiramer acetate with an autoject 2 device for a 4 week treatment period. Patient satisfaction will be evaluated using an Experience Questionnaire throughout the study.

Arms: arm 1: Participants received once daily subcutaneous administration of 20 mg glatiramer acetate as 20 mg/1.0 mL utilizing autoject 2 for glass syringe for two weeks (Period 1), followed by 20 mg/0.5 mL utilizing the autoject 2 device for four weeks (Period 2).
Interventions: intervention 1: Glatiramer Acetate 20 mg/0.5 mL intervention 2: Glatiramer acetate 20 mg/0.5 mL
Intervention descriptions: intervention 1: 20 mg/1.0 mL formulation of glatiramer acetate utilizing the autoject 2 for glass syringe. intervention 2: 20 mg/0.5 mL formulation of glatiramer acetate utilizing the autoject 2 20 mg/0.5 mL device.

Protocol documents:
Clinical trial NCT01174823
Conditions: Allergic Conjunctivitis
Sponsor: Bausch & Lomb Incorporated
Start date: 2010-06-01; Completion date: 2010-12-01
Enrollment: 245 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to study the safety and efficacy of bepotastine besilate ophthalmic solution in allergic conjunctivitis patients.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: bepotastine besilate ophthalmic solution intervention 2: placebo comparator ophthalmic solution
Intervention descriptions: intervention 1: sterile ophthalmic solution intervention 2: sterile ophthalmic solution

Protocol documents:
Clinical trial NCT01179919
Conditions: Obesity
Keywords: Oseltamivir Obesity Influenza Pharmacokinetics in Obesity
Sponsor: Manjunath Prakash Pai
Start date: 2010-07-01; Completion date: 2010-12-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
One in three Americans are obese. Obese subjects may or may not need higher doses of the anti-flu drug known as Tamiflu (oseltamivir). The current study is being done to see if the FDA approved dose of oseltamivir will achieve similar concentrations in obese healthy volunteers compared to that previously shown in non-obese volunteers.

Detailed description:
The incidence of obesity has increased dramatically over the past two decades in the United States (US). Twenty-five percent of adult Americans are now classified as obese. Obesity is associated with physiological alterations that can affect drug clearance and volume of distribution. Obese subjects are often excluded from phase 1 pharmacokinetic studies. As a result, drug dosing regimens developed for clinical use may not be appropriate for the obese population. Use of fixed dosing regimens may result in under dosing of obese patients. In contrast adjustment of drug dosing based on total body weight may lead to over dosing of obese patients. Oseltamivir phosphate (Tamiflu®) is an antiviral agent that is currently dosed as 75 mg once daily for chemoprophylaxis and twice daily for treatment of influenza in adults.

Oseltamivir is rapidly converted to its active metabolite, oseltamivir carboxylate by esterases. The clearance of oseltamivir carboxylate is dependent on tubular secretion and glomerular filtration. Given that these drug elimination pathways may be enhanced in obese individuals, oseltamivir carboxylate plasma exposures may be lower in obese subjects compared to normal weight subjects. Although a specific plasma exposure target for oseltamivir carboxylate has not been established, lower oseltamivir carboxylate exposures may predispose obese patients to treatment failure and increase the probability for emergence of oseltamivir-resistant influenza virus. The current study proposes to characterize the plasma oseltamivir carboxylate concentration-time profile after multiple doses of oral oseltamivir in a cohort of healthy morbidly obese subjects. The study will be performed using a phase 1, open-label,multiple dose, pharmacokinetic study design in twenty obese adult subjects. This pilot study will provide pharmacokinetic data that may be incorporated into existing oseltamivir carboxylate population pharmacokinetic models to define appropriate doses of oseltamivir in obese patients.

Arms: arm 1: Oseltamivir 75 mg by mouth every 12 hours for 9 doses
Interventions: intervention 1: Oseltamivir
Intervention descriptions: intervention 1: Capsule, 75 mg by mouth for 9 doses

Protocol documents:
Clinical trial NCT01181804
Conditions: Hepatitis C
Keywords: boceprevir hepatitis C bioequivalence SCH 503034
Sponsor: Merck Sharp & Dohme LLC
Start date: 2010-06-01; Completion date: 2010-12-01
Enrollment: 177 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is a single-dose, randomized, cross-sectional comparison study examining the relative safety and resulting blood level profiles after administration of a new boceprevir tablet formulation versus its current capsule formulation for treatment of chronic hepatitis C. In Part 1 of the study participants will receive boceprevir tablets and capsules under fed conditions. In Part 2 of the study a new group of participants will receive boceprevir tablets and capsules under fasted conditions.

Detailed description:

Arms: arm 1: Participants will start therapy with a single dose of boceprevir tablets, orally, in fed condition, and then 4 days later will take a single dose of boceprevir capsules, orally, in fed condition. arm 2: Participants will start therapy with a single dose of boceprevir capsules, orally, in fed condition, and then 4 days later will take a single dose of boceprevir tablets, orally, in fed condition. arm 3: Participants will start therapy with a single dose of boceprevir tablets, orally, following an overnight fast, and then 4 days later will take a single dose of boceprevir capsules, orally, following an overnight fast. arm 4: Participants on this study arm will start therapy with a single dose of boceprevir capsules, orally, following an overnight fast, and then 4 days later will take a single dose of boceprevir tablets, orally, following an overnight fast.
Interventions: intervention 1: boceprevir intervention 2: boceprevir intervention 3: boceprevir intervention 4: boceprevir
Intervention descriptions: intervention 1: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions. intervention 2: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions. intervention 3: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions. intervention 4: Boceprevir (tablet or capsule) at 800 mg administered under either fed or fasted conditions.

Protocol documents:
Clinical trial NCT01185548
Conditions: Lymphoma Advanced Cancer
Keywords: Advanced or Metastatic Solid Tumors or Lymphoma
Sponsor: Eli Lilly and Company
Start date: 2010-07-01; Completion date: 2010-12-01
Enrollment: 4 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to assess the effect of tasisulam as an inhibitor of CYP2C9, using tolbutamide as a probe substrate. This study was to have 3 treatment periods, and continued access in an extension period. Period 1 is 4 days in length. Periods 2 and 3 are each approximately 28 days in length. Due to the early termination of the trial, only 1 Period 3 participant enrolled in the extension period before study termination.

Detailed description:

Arms: arm 1: Three study periods and continued access to tasisulam every 28 days (except Period 1 which was tolbutamide only and lasted 4 days) until disease progression:

Period 1: 500 milligram (mg) tolbutamide administered on Day 1.

Period 2: 500 mg of tolbutamide and individualized tasisulam dose \[based on area under the curve albumin-corrected threshold (AUCalb)\]. The AUCalb is a surrogate marker for unbound tasisulam, and this dosing approach represents the maximum level of unbound tasisulam which may be achieved clinically, administered on Day 1.

Period 3: Individualized tasisulam dose (based on AUCalb) administered on Day 1 and 500 mg tolbutamide administered on Day 4.
Interventions: intervention 1: Tolbutamide intervention 2: Tasisulam
Intervention descriptions: intervention 1: Administered orally intervention 2: Administered intravenously

Protocol documents: