ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00770562
Conditions: Idiopathic Thrombocytopenic Purpura
Sponsor: Hoffmann-La Roche
Start date: 2005-07-01; Completion date: 2008-07-01
Enrollment: 103 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will compare the efficacy, safety, and pharmacokinetics of standard treatment versus standard treatment plus MabThera in patients with ITP. The anticipated time on study treatment is \<3 months, and the target sample size is 100-500 individuals.

Detailed description:

Arms: arm 1: Participants received 40 milligrams (mg) dexamethasone, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4). Participants in this treatment arm who failed to achieve a sustained response and had a platelet count of less than or equal to (≤)20 x 10\^9 platelets per liter (L; from Day 30 up to end of 6 months) were treated with salvage treatment of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg per square meter (mg/m\^2), intravenously (IV), with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. arm 2: Participants received dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV, with premedication of oral acetaminophen 500 mg and chlorpheniramine 10 mg IV on Days 7, 14, 21, and 28. Nonresponsive participants with platelets less than (\<) 20 x10\^9/L or with active bleeding could have also received an additional treatment course of dexamethasone 40 mg, orally, once per day for 4 consecutive days (Days 1, 2, 3, and 4) and rituximab 375 mg/m\^2, IV on Days 7, 14, 21, and 28 administered with immunoglobulin (IgG) IV (at investigator discretion) and/or low/medium dose steroids (at investigator discretion) on Days 7, 14, 21, and 28.
Interventions: intervention 1: rituximab intervention 2: Dexamethasone
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT00773136
Conditions: Hypertrichosis
Keywords: Bimatoprost Eyelash lengthening Prostaglandin Analogs Cosmetics
Sponsor: University of Miami
Start date: 2008-02-01; Completion date: 2008-07-01
Enrollment: 21 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Objective: To determine if Lumigan (bimatoprost) causes increased lash length when used in gel suspension applied to the base of the eyelashes. Methods: Subjects recruited from the Bascom Palmer Eye Institute were screened and those who met inclusion criteria were enrolled. Each participant received two vials of gel suspension, which contained bimatoprost and normal saline, respectively, each mixed 1:1 with GonakTM gel and labeled "right eye" and "left eye" according to randomization. The suspension was applied to the eyelashes every evening on the designated eye for 6 weeks. Lash length was measured with a caliper at enrollment, at weekly intervals during the study and at 1 and 3 months after study completion. Visual acuity, ocular symptoms, intraocular pressure and photographs were documented at these same intervals. Results: The average eyelash growth in the Lumigan group was 2.01mm (vs. control average of 1.13mm) which was a statistically significant difference (p=0.009). The average intraocular pressure decreased equally in both groups (2.14 mmHg). No change in visual acuity or iris discoloration was noted in any of the subjects. Discussion: Our data showed an increase in eyelash length with use of Lumigan in gel suspension, suggesting that it may have eyelash lengthening properties.

Detailed description:
Study completed

Arms: arm 1: Intervention to be administered: Each subject was given two suspensions, one mixed with Bimatoprost and one mixed with normal saline. They were instructed to use each suspension to a pre-determined eyelash (prepared prior to study enrollment in double blind fashion and marked after randomization with right and left). The intervention was the one eye with the Bimatoprost.
Interventions: intervention 1: Bimatoprost Suspension
Intervention descriptions: intervention 1: see prior

Protocol documents:
Clinical trial NCT00780442
Conditions: Cocaine Use Disorders
Keywords: substance related disorders
Sponsor: Medical University of South Carolina
Start date: 2006-09-01; Completion date: 2008-07-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
In summary, this pilot study will explore the use of an innovative pharmacologic approach to the treatment of substance dependence through the facilitation of extinction of response to cocaine-conditioned cues in cocaine-dependent individuals. If DCS proves successful in this preliminary study, a controlled treatment trial will be planned. This novel approach could have implications for the treatment of multiple substance use disorders including methamphetamine, marijuana and opiate dependence.

Detailed description:
Cocaine dependence remains a serious problem in the US today and in spite of two decades of intense research, efficacious pharmacotherapeutic treatments have not been identified. Cocaine-associated environmental cues can elicit drug craving and exposure to cocaine-related cues is likely to be involved in relapse. Emerging data supports the role of glutamate in extinction of associative learning in animal models of rear-conditioning and clinical studies of exposure treatment for anxiety disorders. A recent study demonstrated DCS acceleration of cocaine-induced conditioned place preference in rats. Exploration of DCS in facilitating extinction of response to drug-related cues in humans is needed. The proposed study will extend these innovative and promising findings from the basic science arena and anxiety disorders field in a proof of concept investigation of DCS facilitation of extinction of response to cocaine-related cues in a human laboratory paradigm.

Arms: arm 1: D-Cycloserine 50 mg is a partial glutamate agonist. Participants received DCS prior to cocaine cue exposure sessions. arm 2: Saline comparator. Participants received placebo prior to cocaine cue exposure sessions.
Interventions: intervention 1: D-cycloserine intervention 2: Placebo
Intervention descriptions: intervention 1: 50 mg DCS intervention 2: Placebo

Protocol documents:
Clinical trial NCT00818805
Conditions: Allergic Conjunctivitis
Keywords: conjunctivitis
Sponsor: Alcon Research
Start date: 2008-07-01; Completion date: 2008-07-01
Enrollment: 50 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
To evaluate the efficacy of olopatadine 0.1% using the OHIO Chamber in patients with seasonal allergic conjunctivitis.

Detailed description:

Arms: arm 1: Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye arm 2: Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye arm 3: Patients received one drop Olopatadine 0.1% in one eye and 1 drop Olopatadine placebo in contralateral eye arm 4: Patients received one drop Tranilast ophthalmic solution 0.5% in one eye and 1 drop tranilast placebo in contralateral eye
Interventions: intervention 1: Olopatadine 0.1% intervention 2: Tranilast 0.5% intervention 3: Placebo (Olopatadine) intervention 4: Placebo (Tranilast)
Intervention descriptions: intervention 1: one drop in one eye intervention 2: one drop in one eye intervention 3: one drop in contralateral eye intervention 4: one drop in contralateral eye

Protocol documents:
Clinical trial NCT00875212
Conditions: Dental Caries
Keywords: Calcium glycerophosphate Fluoride Dentifrice Biofilm Dental caries
Sponsor: Federal University of Paraíba
Start date: 2006-01-01; Completion date: 2008-07-01
Enrollment: 12 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The aim of this study was to investigate the buffering effect of a calcium glycerophosphate-fluoride (CaGP-F) dentifrice on in vivo dental biofilm after a cariogenic challenge and evaluate its probable 12-hour protective effect. Twelve young adults took part in this randomized, double blind, 14-day 4-phase crossover study. Between each phase, the volunteers had a 1-week wash-out period. Coded dentifrices were randomly assigned to the volunteers: A) no F and no CaGP; B) CaGP-only (0.13%); C) F-only (1500 ppm (ppm= parts per million of fluoride which is equivalent to mg/kg)); D) CaGP-F (0.13%, 1500 ppm, respectively). The pH measurements were taken from a single-site using a microelectrode, with salt bridge established by a 1M KCl (one molar potassium chloride) solution with a reference electrode. pH measurements were taken at 0 (baseline), 1, 7, 14 and 21 min (minutes) after a cariogenic challenge (10% w/v sucrose solution, %w/v = percent weight per volume). Four sets of measurements were carried out: (D0BS) before test dentifrice usage; (D01min) 1-min after test dentifrice usage; and (D712h) 7 days and (D1412h) 14 days using the test dentifrice, 12 hours (h)after brushing. Stephen curves and mean AUC (area under the curve) were obtained.

Detailed description:
Although the mechanisms of action of fluoride are reasonably understood, the mechanism of calcium phosphate and calcium glycerophosphate (CaGP) are still a matter of debate. It has been suggested that CaGP increases the phosphorus content in the biofilm and, as a result, the buffering capacity of the biofilm is intensified. The pH levels of the biofilm are maintained above the 5.0-5.5 range. This is above the critical range for enamel demineralization.

Arms: arm 1: 4 types of dentifrices were used in 4 different periods in a crossover study design.
Interventions: intervention 1: calcium glycerophosphate intervention 2: no active ingredient intervention 3: fluoride intervention 4: CAGP + fluoride
Intervention descriptions: intervention 1: use of a dentifrice containing CaGP (0.13%) and no fluoride intervention 2: dentifrice without calcium glycerophosphate and no fluoride intervention 3: use of a dentifrice containing fluoride (1500ppm) only intervention 4: calcium glycerophosphate and fluoride dentifrice

Protocol documents:
Clinical trial NCT00905515
Conditions: Kidney Transplantation
Keywords: Kidney Transplantation Immunosuppressive Agents
Sponsor: East Carolina University
Start date: 2003-08-01; Completion date: 2008-07-01
Enrollment: 63 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study is designed to optimize calcineurin immunosuppressive regimens and evaluate immunological and non-immunological markers that may explain mechanistic differences in these agents and their effects.

Detailed description:
One of the major challenges in transplantation over the past two decades has been managing long-term renal function. Serum creatinine is the most commonly used serum marker of renal function. However serum creatinine is insensitive for detecting small decreases in glomerular filtration rate (GFR). Another marker for renal function is cystatin C. Dharnidharka et al concluded that cystatin C is superior to serum creatinine as a marker of kidney function since cystatin C was a more sensitive marker than serum creatinine for detecting decreases in GFR. Pirsch et al reported that tacrolimus-treated patients had a lower incidence of severe acute rejection and better lipid profiles than cyclosporine-treated patients.

Cardiovascular disease is the primary cause of premature death in renal and other transplant recipients. Current immunosuppressive protocols often elevate cardiovascular disease risk factors such as hypertension, hyperlipidemia, obesity and diabetes.

This study is designed to optimize calcineurin immunosuppressive regimens to ensure the best possible long-term outcomes after renal transplantation.

Arms: arm 1: Maintain on Cyclosporine (CsA) at target trough level of 50-250 ng/mL. arm 2: Convert to Prograf (TAC) at target trough levels of 3.0-5.9 ng/mL. arm 3: Convert to TAC at target trough levels of 6.0-8.9 ng/mL.
Interventions: intervention 1: cyclosporine intervention 2: Prograf (Tacrolimus)
Intervention descriptions: intervention 1: Maintain on cyclosporine at target trough level of 50-250 ng/mL. intervention 2: Convert to Prograf at target trough levels of 3.0-5.9 ng/mL (Arm 2) or target trough levels of 6.0-8.9 ng/mL (Arm 3).

Protocol documents:
Clinical trial NCT01121900
Conditions: Healthy
Keywords: Healthy subjects
Sponsor: Labopharm Inc.
Start date: 2008-06-01; Completion date: 2008-07-01
Enrollment: 26 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The objective of this study was to compare the pharmacokinetic profiles of the test product, 300 mg trazodone hydrochloride (HCl) extended-release caplets (containing Contramid®), when administered as a single dose, and the reference product, 100 mg trazodone HCl immediate-release tablets (Apotex Corp), when administered three times daily. For this purpose the rate and extent of absorption of trazodone and formation of m-chlorophenylpiperazine (mCPP) after administration of the two formulations, were compared under fasting conditions.

Detailed description:

Arms: arm 1: OAD: Once A Day arm 2: None
Interventions: intervention 1: Trazodone HCl intervention 2: Trazodone HCl
Intervention descriptions: intervention 1: Dosage form: Extended-release caplets containing 300 mg trazodone HCl

Dose: 300 mg trazodone HCl extended-release caplets (one caplet) at 23:30 on Day 1 of the test product treatment period following a fasting period of at least 4 hours. intervention 2: Dosage form: Immediate-release tablets containing 100 mg trazodone HCl

Dose: 100 mg trazodone HCl immediate-release tablets (one tablet per dosing time) at 23:30 on Day 1, at 07:30 and 15:30 on Day 2 of the reference product treatment period.

Protocol documents:
Clinical trial NCT01203072
Conditions: Venous Thromboembolism Deep Vein Thrombosis Total Knee Arthroplasty
Keywords: prevention venous thromboembolism edoxaban factor Xa
Sponsor: Daiichi Sankyo Co., Ltd.
Start date: 2006-07-01; Completion date: 2008-07-01
Enrollment: 523 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective of this study is to assess the efficacy, safety and dose-response relationship of DU-176b compared with placebo for the prevention of venous thromboembolism in patients after elective total knee arthroplasty.

Detailed description:

Arms: arm 1: None arm 2: None arm 3: None arm 4: None arm 5: None
Interventions: intervention 1: DU-176b intervention 2: DU-176b intervention 3: DU-176b intervention 4: DU-176b intervention 5: Placebo
Intervention descriptions: intervention 1: DU-176b 5mg tablets oral, once daily for 2 weeks intervention 2: DU-176b 15mg tablets, oral once daily for 2 weeks intervention 3: DU-176b 30 mg tablets, oral, once daily for 2 weeks intervention 4: DU-176b 60 mg tablets, oral, once daily for 2 weeks intervention 5: Matching placebo oral tablets, once daily for 2 weeks

Protocol documents:
Clinical trial NCT01258101
Conditions: Hepatitis C, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2003-05-01; Completion date: 2008-07-01
Enrollment: 395 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This randomized, parallel arm study will evaluate the efficacy and safety of Pegasys (peginterferon alfa-2a) in combination with 2 different doses of ribavirin in patients with chronic hepatitis C, genotype 2 or 3. Patients will be randomized to 4 treatment groups receiving Pegasys (180 mcg subcutaneously weekly) for either 16 or 24 weeks with one of two doses of ribavirin (400 mg or 800 mg orally daily). The anticipated time on study treatment is 16 or 24 weeks with a 24-week follow-up.

Detailed description:

Arms: arm 1: Participants received peginterferon alfa-2a (PEG-IFNα-2a) 180 mcg once weekly + Ribavirin 800 mg daily for 24 weeks (W). arm 2: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 24 W. arm 3: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 800 mg daily for 16 W. arm 4: Participants received PEG-IFNα-2a 180 mcg once weekly + Ribavirin 400 mg daily for 16 W.
Interventions: intervention 1: peginterferon alfa-2a [Pegasys] intervention 2: peginterferon alfa-2a [Pegasys] intervention 3: ribavirin intervention 4: ribavirin
Intervention descriptions: intervention 1: 180 mcg sc weekly, 24 weeks intervention 2: 180 mcg sc weekly, 16 weeks intervention 3: 800 mg orally daily intervention 4: 400 mg orally daily

Protocol documents:
Clinical trial NCT01278394
Conditions: Onychomycosis
Keywords: Onychomycosis Fungal Nail
Sponsor: Pfizer
Start date: 2007-03-01; Completion date: 2008-07-01
Enrollment: 29 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to determine the safety and efficacy of 5.0% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.

Detailed description:
In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical evaluation of the targeted great nail, marking whether or not they considered the nail to be clear of onychomycosis. This evaluation was the basis for determining whether or not study medication should be dispensed at the visit.

This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1\&2 and Cohort 3.

Arms: arm 1: AN2690 Solution, 5.0%
Interventions: intervention 1: AN2690 Solution, 5.0%
Intervention descriptions: intervention 1: Once daily application for 360 days

Protocol documents:
Clinical trial NCT01365624
Conditions: Healthy Subjects
Sponsor: American Regent, Inc.
Start date: 2008-02-01; Completion date: 2008-07-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study had an open-label, single-dose design. All subjects received a single dose of 30 mg of intranasal ketorolac. Blood samples for determination of ketorolac plasma levels were obtained pre-dose and at specified time points over 24 hours post-dose.

The primary objective of this trial was to compare the pharmacokinetics of intranasal ketorolac between elderly and nonelderly adult subjects. The secondary objective was to evaluate the safety profile of intranasal ketorolac in elderly subjects.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ketorolac tromethamine
Intervention descriptions: intervention 1: Single dose of 30 mg of intranasal Ketorolac tromethamine (100 uL of a 15% solution in each nostril)

Protocol documents:
Clinical trial NCT02780622
Conditions: Drug Therapy, Combination
Sponsor: Hoffmann-La Roche
Start date: 2008-02-01; Completion date: 2008-07-01
Enrollment: 20 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This is an open-label, randomized, 2-period crossover study, to evaluate the pharmacokinetics, pharmacodynamics, safety and tolerability of warfarin in combination with Tamiflu (oseltamivir) in participants stabilized on warfarin. Participants will be randomized to receive either their warfarin followed oseltamivir and warfarin, or by oseltamivir and warfarin followed by warfarin. The treatment periods will be separated by a washout period of at least 4 days. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study.

Detailed description:

Arms: arm 1: Participants will receive warfarin (on Days 1-5) in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants will then receive oseltamivir 75 milligram (mg) (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 2, and attend a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study. arm 2: Participants will receive oseltamivir 75 mg (orally twice daily on Days 1-4 and once on Day 5) and warfarin in Treatment Period 1, followed by a washout period of at least 4 days (maximum 8 days). Participants will then receive warfarin (on Days 1-5) in Treatment Period 2, and attend a follow-up visit 4-12 days after the last dose in Treatment Period 2. Participants will continue receiving warfarin once daily at a prescribed usual dose throughout the study.
Interventions: intervention 1: Oseltamivir intervention 2: Warfarin
Intervention descriptions: intervention 1: Oseltamivir 75 mg orally, twice daily for 4 days and once on Day 5. intervention 2: Warfarin once daily, at a dose determined through titration by participants' usual hematologist.

Protocol documents:
Clinical trial NCT02791269
Conditions: Hepatitis B, Chronic
Sponsor: Hoffmann-La Roche
Start date: 2006-01-01; Completion date: 2008-07-01
Enrollment: 24 participants; Allocation: NON_RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is an expanded access, multicenter, national, open-label, and non-randomized study to analyze the safety of peginterferon alfa-2a in participants with hepatitis B e antigen (HBeAg) positive and HBeAg negative chronic HBV infection. All participants will receive 48 weeks treatment of peginterferon alfa-2a monotherapy, followed by a 24 week treatment-free follow-up period.

Detailed description:

Arms: arm 1: HBeAg negative participants will receive peginterferon alfa-2a 180 micrograms (mcg) subcutaneous (SC) injection once weekly (QW) for 48 weeks followed by a 24 weeks treatment-free follow-up period. arm 2: HBeAg Positive participants will receive peginterferon alfa-2a 180 mcg SC injection QW for 48 weeks followed by a 24 weeks treatment-free follow-up period.
Interventions: intervention 1: Peginterferon alfa-2a
Intervention descriptions: intervention 1: 180 mcg SC injection QW for 48 weeks.

Protocol documents: