ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00702325
Conditions: Asthma
Keywords: Asthma
Sponsor: AstraZeneca
Start date: 2008-06-01; Completion date: 2009-09-01
Enrollment: 311 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To compare the efficacy of SYMBICORT® pMDI 160/4.5 μg x 2 actuations twice daily (bid) to that of budesonide inhalation powder DPI 180 μg x 2 inhalations bid, in African American(self-reported) subjects with inhaled corticosteroid (ICS) dependent asthma.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Budesonide / formoterol fumarate (SYMBICORT) intervention 2: Budesonide
Intervention descriptions: intervention 1: 160/4.5 μg x 2 actuations twice daily (bid) intervention 2: inhalation powder 180 μg x 2 inhalations bid (PULMICORT)

Protocol documents:
Clinical trial NCT00704496
Conditions: Rhinitis Sleep
Keywords: Sleep, Pseudoephedrine
Sponsor: Milton S. Hershey Medical Center
Start date: 2007-06-01; Completion date: 2009-09-01
Enrollment: 34 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue.

Detailed description:
The hypothesis is that pseudoephedrine, a sympathomimetic amine commonly used as a decongestant, will decrease nasal congestion leading to increased patency of the nose and a decrease in nighttime sleep fragmentation in individuals with year round perennial allergic rhinitis (PAR). This decrease in sleep fragmentation will reduce daytime somnolence and fatigue. We studied patients treated with placebo compared to FDA approved dose of pseudoephedrine and assessed sleep, QOL and daytime sleepiness.

Arms: arm 1: Placebo arm 2: Pseudoephedrine is a 240 mg PO per day
Interventions: intervention 1: Pseudoephedrine
Intervention descriptions: intervention 1: Pseudoephedrine is a 240 mg PO per day

Protocol documents:
Clinical trial NCT00712543
Conditions: Constipation
Keywords: constipation laxative lactulose Kristalose®
Sponsor: Cumberland Pharmaceuticals
Start date: 2009-06-01; Completion date: 2009-09-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Detailed description:
This study will evaluate whether patients have an overall preference for Kristalose® or liquid lactulose based on taste, consistency, and portability.

Arms: arm 1: Kristalose®, as prescribed, for 7 days. arm 2: Liquid lactulose, as prescribed, for 7 days.
Interventions: intervention 1: lactulose (Kristalose®) intervention 2: liquid lactulose
Intervention descriptions: intervention 1: Crystals to be dissolved in water and taken as prescribed. intervention 2: Liquid to be taken as prescribed.

Protocol documents:
Clinical trial NCT00715403
Conditions: Neoplasms
Sponsor: Boehringer Ingelheim
Start date: 2004-10-01; Completion date: 2009-09-01
Enrollment: 41 participants; Allocation: ; Intervention model: 

Brief summary:
The primary objective of this trial is to evaluate the long-term safety of BIBF 1120 in terms of incidence and intensity of Adverse Events and changes in safety laboratory parameters.

Secondary objectives are the collection of further safety data (vital signs), efficacy data and the determination of pharmacokinetic characteristics during long-term therapy with BIBF 1120.

Detailed description:

Interventions: intervention 1: BIBF 1120
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00719329
Conditions: Infection
Keywords: chlorhexidine umbilical cord
Sponsor: Johns Hopkins Bloomberg School of Public Health
Start date: 2008-08-01; Completion date: 2009-09-01
Enrollment: 1931 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Background: In developing countries, many babies are born at home and the umbilical cord commonly becomes infected during the first week after birth, and can be deadly. Cleansing of the cord with a low-cost antiseptic like chlorhexidine may reduce the risk of these infections. Little is known, however, about the frequency of chlorhexidine cleansing needed to impact upon the overall presence of bacteria on the stump, or regarding the changes in bacteria during the first week of life when most cord infections occur.

Objectives: We will describe the profile of bacteria colonizing the umbilical cord stump of infants in rural Bangladesh and examine the role of topical chlorhexidine in altering colonization and progress of infection. We will compare the overall and bacteria-specific rate of colonization of the cord stump between infants receiving chlorhexidine cleansing of their cord through the first day or first week of life. We will also quantify the relationship between colonization of the cord stump with specific pathogens and the presence and severity of signs of umbilical cord infection (pus, redness, swelling) among these newborns.

Potential Impact: More information is needed on the impact of single versus repeated applications of chlorhexidine to the cord stump, as the number of cleansing may substantially influence the feasibility of widespread scale-up in many populations. The data generated from this proposed study will guide the most appropriate design of this simple intervention and will help inform specific treatment protocols for effective management of infants with signs of umbilical cord infections.

Detailed description:

Arms: arm 1: Chlorhexidine cleansing of the cord for seven days arm 2: Chlorhexidine cleansing of the cord for 1 day arm 3: Dry cord care, as recommended by WHO
Interventions: intervention 1: Chlorhexidine 4.0% intervention 2: Dry Cord Care
Intervention descriptions: intervention 1: Solution (4.0%, 7.1% CHX-D) intervention 2: Educational messages regarding clean cord care

Protocol documents:
Clinical trial NCT00724126
Conditions: Non-Constipation Irritable Bowel Syndrome
Keywords: Diarrhea Rifaximin IBS Abdominal pain Bloating
Sponsor: Bausch Health Americas, Inc.
Start date: 2008-07-01; Completion date: 2009-09-01
Enrollment: 637 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.

Detailed description:

Arms: arm 1: Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. arm 2: Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Interventions: intervention 1: Rifaximin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00731679
Conditions: Non-Constipation Irritable Bowel Syndrome
Keywords: IBS Abdominal pain Bloating Diarrhea Rifaximin
Sponsor: Bausch Health Americas, Inc.
Start date: 2008-07-01; Completion date: 2009-09-01
Enrollment: 623 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate the efficacy of a 14-day course of rifaximin given 3 times a day vs. placebo in providing adequate relief of IBS symptoms.

Detailed description:

Arms: arm 1: Subjects received placebo tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period. arm 2: Subjects received rifaximin 550 mg tablets 3 times daily for 2 weeks and were followed for 10 weeks after completion of the treatment period.
Interventions: intervention 1: Rifaximin intervention 2: Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00734604
Conditions: Erectile Dysfunction
Sponsor: Eli Lilly and Company
Start date: 2008-08-01; Completion date: 2009-09-01
Enrollment: 378 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary purpose of the study is to help answer whether tadalafil taken once a day can help improve the psychological outcomes (such as sexual self confidence, spontaneity and time concerns) compared to sildenafil taken as needed in patients with erectile dysfunction (ED).

Detailed description:

Arms: arm 1: Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks arm 2: Tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks arm 3: Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks arm 4: Sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks arm 5: Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks arm 6: Tadalafil 20 mg as needed \[T(PRN)\] for 8 weeks, 1 week washout, sildenafil citrate 100 mg as needed \[S(PRN)\] for 8 weeks, 1 week washout, tadalafil 5 mg once a day \[T(OaD)\] for 8 weeks
Interventions: intervention 1: tadalafil once a day [T(OaD)] intervention 2: sildenafil citrate as needed [S(PRN)] intervention 3: tadalafil as needed [T(PRN)]
Intervention descriptions: intervention 1: 5 mg tablet taken once a day (OaD) by mouth for 8 weeks intervention 2: 100 mg tablet taken as needed (PRN) by mouth for 8 weeks intervention 3: 20 mg tablet taken as needed (PRN) by mouth for 8 weeks

Protocol documents:
Clinical trial NCT00743145
Conditions: Marijuana Smoking
Keywords: naltrexone smoked marijuana marijuana use
Sponsor: New York State Psychiatric Institute
Start date: 2008-05-01; Completion date: 2009-09-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
In heavy marijuana smokers, opioid receptor blockade increases the subjective and cardiovascular effects of marijuana. The current study was designed to clarify opioid-cannabinoid interactions by assessing how naltrexone shifts the dose-response function for marijuana-elicited effects in heavy marijuana smokers. For this within-subject, double-blind study, a marijuana smoking procedure was designed to characterize a dose-response relationship for marijuana's subjective and cardiovascular effects under blinded conditions.

Detailed description:

Arms: arm 1: Placebo naltrexone capsules (0mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order. arm 2: Placebo naltrexone capsules (0mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. arm 3: Placebo naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order. arm 4: Naltrexone capsules (12mg), active marijuana (5.5% THC). Each study participant underwent 8 conditions in a randomized order. arm 5: Naltrexone capsules (0mg), active marijuana (6.2% THC). Each study participant underwent 8 conditions in a randomized order. arm 6: Naltrexone capsules (12mg), inactive marijuana (0% THC). Each study participant underwent 8 conditions in a randomized order.
Interventions: intervention 1: Inactive Marijuana (0% THC) intervention 2: Active Marijuana (5.5% THC) intervention 3: Active Marijuana (6.2% THC) intervention 4: Naltrexone intervention 5: Placebo naltrexone
Intervention descriptions: intervention 1: Marijuana cigarette containing 0% THC intervention 2: Marijuana cigarette containing 5.5% THC intervention 3: Marijuana cigarette containing 6.2% THC intervention 4: Naltrexone (12mg/70kg) intervention 5: Naltrexone (0mg)

Protocol documents:
Clinical trial NCT00746096
Conditions: Dysmenorrhea
Sponsor: Nobelpharma
Start date: 2008-09-01; Completion date: 2009-09-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether combination oral contraceptive pill of norethindrone and ethinyl estradiol is effective in the treatment of primary dysmenorrhea.

Detailed description:

Arms: arm 1: ethinyl estradiol 0.035mg and norethisterone 1mg arm 2: Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg
Interventions: intervention 1: IKH-01 intervention 2: Placebo
Intervention descriptions: intervention 1: ethinyl estradiol 0.035mg and norethisterone 1mg intervention 2: Placebo for ethinyl estradiol 0.035mg and norethisterone 1mg

Protocol documents:
Clinical trial NCT00761319
Conditions: Open-angle Glaucoma Ocular Hypertension
Keywords: Open-angle glaucoma ocular hypertension
Sponsor: Alcon Research
Start date: 2008-10-01; Completion date: 2009-09-01
Enrollment: 705 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to compare two ophthalmic solutions in patients with open-angle glaucoma or ocular hypertension.

Detailed description:

Arms: arm 1: One drop self-administered in the study eye(s) once daily for 90 days arm 2: One drop self-administered in the study eye(s) once daily for 90 days
Interventions: intervention 1: Travoprost ophthalmic solution 0.004% with SofZia® preservative system (TRAVATAN Z®) intervention 2: Latanoprost ophthalmic solution 0.005% (XALATAN®)
Intervention descriptions: intervention 1: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as travoprost. intervention 2: Ophthalmic solution for the treatment of open-angle glaucoma or ocular hypertension, one drop a day, dosed topically for 90 days. Referred to as latanoprost.

Protocol documents:
Clinical trial NCT00776919
Conditions: Acne Vulgaris
Keywords: Acne Vulgaris Acne
Sponsor: Stiefel, a GSK Company
Start date: 2008-10-01; Completion date: 2009-09-01
Enrollment: 1315 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a Randomized, Double-Blind, Controlled Study to evaluate the Safety and Efficacy of a clindamycin / benzoyl peroxide gel in Subjects with Acne Vulgaris

Detailed description:
A multicenter, randomized, double-blind, comparator and vehicle-controlled study in subjects with acne vulgaris. Approximately 1320 subjects will be enrolled. Subjects will be randomized to 1 of 4 parallel study groups in a 1:1:1:1 ratio (clindamycin / benzoyl peroxide gel:clindamycin gel:BPO gel:vehicle gel).

Arms: arm 1: clindamycin / benzoyl peroxide gel arm 2: Clindamycin gel arm 3: BPO gel arm 4: vehicle gel
Interventions: intervention 1: clindamycin / benzoyl peroxide gel intervention 2: clindamycin gel intervention 3: BPO gel intervention 4: vehicle gel
Intervention descriptions: intervention 1: Once a day application to the face intervention 2: Once a day application to the face intervention 3: Once a day application to the face intervention 4: Once a day application to the face

Protocol documents:
Clinical trial NCT00780455
Conditions: Multiple Sclerosis, Relapsing-Remitting
Keywords: KineSEP Rehabilitation Betaferon
Sponsor: Bayer
Start date: 2008-10-01; Completion date: 2009-09-01
Enrollment: 4 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Studying the effectiveness of a functional rehabilitation protocol (FRP) in early Relapsing Remitting Multiple Sclerosis (RRMS) patients treated with Betaferon by comparing the physical ability of patients with and without FRP.

Detailed description:

Arms: arm 1: Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) within 15 days after randomization arm 2: Interferon beta-1b (Betaseron, BAY86-5046) 250 microgram (8 MUI), sub-cutaneous, administration every other day, Participants starting the 6 weeks functional rehabilitation protocol (FRP) about 6 weeks after randomization
Interventions: intervention 1: Interferon beta-1b, FRP within 15 days after randomization intervention 2: Interferon beta-1b, FRP about 6 weeks after randomization
Intervention descriptions: intervention 1: Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program starting within 6 weeks after randomization intervention 2: Treatment by Interferon beta-1b (Betaseron, BAY86-5046) for 3 month and beginning of the Functional Rehabilitation Program about 6 weeks after randomization.

Protocol documents:
Clinical trial NCT00782639
Conditions: Chronic Renal Impairment Diabetes Mellitus
Sponsor: Bracco Diagnostics, Inc
Start date: 2009-03-01; Completion date: 2009-09-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with moderate-to-severe chronic kidney disease and diabetes mellitus undergoing cardiac angiography.

Detailed description:
This was a Phase IV, multicenter, randomized, double-blind, parallel-group comparison of iopamidol-370 and iodixanol-320 in patients at high risk for CIN, i.e., patients with:

* Stage 3 or 4 CKD (SCr level of ≥ 1.5 mg/dL for men and ≥1.3 mg/dL for women or eGFR between 15 and 50 mL/min, and
* Diabetes mellitus who would undergo clinically indicated cardiac angiography procedures. Approximately 10 investigative centers were to participate in this study. This study was to enroll approximately 220 patients to ensure that 200 evaluable patients were able to complete the study according to this protocol.

Patients were to be randomized to receive either iopamidol-370 or iodixanol-320. Each patient was to be evaluated for the occurrence of CIN within 48 to 72 hours postdose.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Iopamidol injection 76% intervention 2: iodixanol
Intervention descriptions: intervention 1: Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution intervention 2: Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution

Protocol documents:
Clinical trial NCT00790556
Conditions: Type 2 Diabetes
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-10-01; Completion date: 2009-09-01
Enrollment: 14 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A 2-period crossover study to assess the safety, tolerability and glucose-lowering effects of MK8245.

Detailed description:
Hypothesis: Multiple doses of MK-8245 are sufficiently safe and well tolerated in patients with Type 2 diabetes based on an assessment of clinical and laboratory adverse experiences (AEs), to permit continued clinical investigation.

Arms: arm 1: MK8245 arm 2: Placebo Comparator
Interventions: intervention 1: MK8245 intervention 2: Comparator: Placebo
Intervention descriptions: intervention 1: MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken. intervention 2: MK8245 placebo capsules twice daily for 13 days. On Day 14, only the morning dose of study medication will be taken. There will be a 14 day washout period. Patients will then crossover to MK8245 50 mg capsules twice daily for 13 days. On Day 14, only the morning dose of study drug will be taken.

Protocol documents:
Clinical trial NCT00791258
Conditions: Hypertension
Sponsor: Daiichi Sankyo
Start date: 2008-11-01; Completion date: 2009-09-01
Enrollment: 999 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The initial 12 week portion of this 20 week study will examine the ability of a combination of olmesartan medoxomil and amlodipine to lower the blood pressure of patients with high blood pressure who have not had sufficient blood pressure reduction using one anti-hypertension drug (monotherapy). The final 8 weeks of this 20 week study will examine the ability of a combination of olmesartan medoxomil, amlodipine and hydrochlorothiazide to lower blood pressure in the same patient population. All three medications being tested have been approved by the FDA for the treatment of high blood pressure, but only amlodipine and olmesartan are currently approved for use in combination form.

Detailed description:

Arms: arm 1: Azor tablets and hydrochlorothiazide tablets (if necessary) will be administered for up to 20 weeks
Interventions: intervention 1: amlodipine and olmesartan medoxomil tablets intervention 2: hydrochlorothiazide tablets
Intervention descriptions: intervention 1: amlodipine and olmesartan medoxomil tablets administered orally, once daily for up to 20 weeks intervention 2: hydrochlorothiazide tablets may be administered orally, if necessary once daily, for up to 8 weeks

Protocol documents:
Clinical trial NCT00812110
Conditions: Influenza
Keywords: Influenza prevention
Sponsor: Akron Children's Hospital
Start date: 2008-12-01; Completion date: 2009-09-01
Enrollment: 336 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
We hypothesize that when offered influenza vaccine at little or no cost, in a setting where the value of the vaccine is connected to one's high risk child, vaccination rates for parents will approach 90-95%, similar to rates obtained in the Neonatal Intensive Care Unit environment.

Detailed description:

Interventions: intervention 1: Influenzae vaccine
Intervention descriptions: intervention 1: 0.5 mL Deltoid Intramuscular Injection X 1

Protocol documents:
Clinical trial NCT00818454
Conditions: Asthma
Sponsor: Boehringer Ingelheim
Start date: 2008-12-01; Completion date: 2009-09-01
Enrollment: 226 participants; Allocation: ; Intervention model: CROSSOVER

Brief summary:
The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI with albuterol HFA MDI, the current standard reliever medication in asthma. In the first cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC MDI will be used. In the second, parallel group part of the trial (Treatment Phase 3) COMBIVENT RESPIMAT will be tested for acute bronchodilator efficacy in a blinded manner at the clinic visits. During the third 4-week treatment phase open label COMBIVENT RESPIMAT will be used for symptom relief as needed.

Detailed description:

Interventions: intervention 1: Combivent CFC MDI intervention 2: Albuterol HFA MDI intervention 3: Respimat Combivent
Intervention descriptions: intervention 1: None intervention 2: None intervention 3: None

Protocol documents: