ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00922480
Conditions: Hypertension
Keywords: Hypertension Losartan
Sponsor: Boryung Pharmaceutical Co., Ltd
Start date: 2008-12-01; Completion date: 2009-09-01
Enrollment: 506 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the antihypertensive efficacy and safety of Fimasartan (BR-A-657•K) 60 mg\~120 mg in patients with mild to moderate essential hypertension.

Detailed description:
Fimasartan (BR-A-657-K), a selective blocker of AT1 receptor subtype, showed the rapid and potent antihypertensive effect in many hypertensive models. Phase I study, Fimasartan (BR-A-657-K) 20mg \~ 480mg single dosing with healthy subjects, demonstrated that the Fimasartan(BR-A-657-K) was very safe and well tolerated. Another phase I study, Fimasartan (BR-A-657-K) 120mg and 360mg dosing for 7 days, also showed that Fimasartan (BR-A-657-K) was safe and tolerable though one temporal adverse event was observed in high dose.

A Randomized, Double-blind, Losartan-controlled, Parallel Group Comparison Dose Titration Clinical Study to Evaluate the Antihypertensive Efficacy and Safety of Fimasartan (BR-A-657•K) 60mg\~120mg in Patients with Mild to Moderate Essential Hypertension.

Approximately 480 patients will be enrolled over 12 months in 24 centers nationwide.

After 2 weeks of placebo run-in period, all subjects will be randomized into one of the following 2 groups. Subjects will take test/control drug for 12 weeks of treatment period. And Extensin study have 12 weeks in treatment period.

If subjects take any antihypertensive medications before screening, the subjects will have 1 week of wash-out period.

If the hypertension is not controlled well, there is a possibility of dose titration.

Group I : Fimasartan group. Group II : Losartan group

Arms: arm 1: Losartan group arm 2: Fimasartan 60mg, 120mg
Interventions: intervention 1: Fimasartan intervention 2: Losartan (Control)
Intervention descriptions: intervention 1: Fimasartan 60 \~ 120mg/po take one tablets once a day intervention 2: Losartan 50 mg \~ 100 mg/po, take one tablets once a day

Protocol documents:
Clinical trial NCT00932477
Conditions: Dry Eye Syndrome
Sponsor: Allergan
Start date: 2009-08-01; Completion date: 2009-09-01
Enrollment: 47 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The safety and tolerability of two new artificial tears will be compared to a currently-available artificial tear in subjects with dry eye. Each subject will receive all three products in a randomly assigned order. The subject will use one product at a time for a duration of one week before switching to the next assigned product.

Detailed description:

Arms: arm 1: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear arm 2: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear arm 3: Glycerin and Polysorbate 80 based artificial tear
Interventions: intervention 1: Formulation 1: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear intervention 2: Formulation 2: Carboxymethylcellulose Sodium, Glycerin and Polysorbate 80, based artificial tear intervention 3: Glycerin and Polysorbate 80 based artificial tear
Intervention descriptions: intervention 1: 1 to 2 drops into each eye three times per day intervention 2: 1 to 2 drops into each eye three times per day intervention 3: 1 to 2 drops into each eye three times per day

Protocol documents:
Clinical trial NCT00951561
Conditions: Dysmenorrhea
Keywords: Dysmenorrhea
Sponsor: Another Way Products
Start date: 2006-11-01; Completion date: 2009-09-01
Enrollment: 115 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the Vipon tampon with ibuprofen in relieving pain in women with dysmenorrhea. Subjects completed a total of 4 treatment intervals; each subject was randomized to use the VIPON as their treatment for two intervals and Ibuprofen as their treatment for two intervals.

Detailed description:
Pain caused by dysmenorrhea can range from mild to severe. At least 50% of all menstruating women experience appreciable pain at some time during their menstruation. An estimated 600 million work hours are lost annually to this affliction with an average loss of time of two or more workdays per year per female employee. Treatment of dysmenorrhea may include either non-pharmacological or pharmacological measures. Pharmacological treatments include oral contraceptives to treat hormonal imbalances, over-the-counter analgesics or non-steroidal anti-inflammatory drugs. The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation. This study aims to provide information on the safety and efficacy of the Vipon in a randomized controlled clinical trial.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Vipon intervention 2: Ibuprofen
Intervention descriptions: intervention 1: The Vipon is a tampon with a small motor unit within, which produces vibratory stimulation, used during menstruation to provide pain relief for women with dysmenorrhea. intervention 2: 400 mg daily

Protocol documents:
Clinical trial NCT00955110
Conditions: Healthy
Keywords: Opioid Recreational Oxymorphone Oxycodone Extended Release Healthy NonDependent Recreational Opioid Users
Sponsor: Endo Pharmaceuticals
Start date: 2009-06-01; Completion date: 2009-09-01
Enrollment: 78 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to compare the subjective and objective effects of Oxymorphone ER (Opana ER) versus Oxycodone CR (Oxycontin).

Detailed description:

Arms: arm 1: 15mg arm 2: 30mg arm 3: None arm 4: 30mg arm 5: 60mg
Interventions: intervention 1: Oxymorphone ER intervention 2: Oxycodone CR intervention 3: Placebo intervention 4: Hydromorphone
Intervention descriptions: intervention 1: 15mg or 30mg intervention 2: 30mg or 60mg intervention 3: The placebo was a sugar pill. intervention 4: 8 mg

Protocol documents:
Clinical trial NCT01000376
Conditions: Cancer
Keywords: Cancer solid tumors
Sponsor: Eisai Limited
Start date: 2009-02-01; Completion date: 2009-09-01
Enrollment: 12 participants; Allocation: NON_RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The purpose of this study is to investigate whether ketoconazole, taken orally, influences the level of eribulin in the blood when the two drugs are given at the same time. The study will enroll patients with solid tumors whose cancer became worse even after standard treatment, or for whom there is no standard treatment available. The study will also investigate whether eribulin given together with ketoconazole is safe (has few side-effects) and is effective against cancer.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Eribulin alone intervention 2: Eribulin plus Ketoconazole
Intervention descriptions: intervention 1: Group 1 Cycle 1 (28 days): Eribulin IV 1.4 mg/m\^2 alone on Day 1, then eribulin IV 0.7 mg/m\^2 plus oral ketoconazole 200 mg on Day 15 and oral ketoconazole 200 mg alone on Day 16. Subsequently, subjects were able to receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days. intervention 2: Group 2 Cycle 1 (28 days): Eribulin IV 0.7 mg/m\^2 plus oral ketoconazole 200 mg on Day 1, then oral ketoconazole 200 mg alone on Day 2 and eribulin IV 1.4 mg/m\^2 alone on Day 15. Subsequently, subjects were able to receive eribulin 1.4 mg/m\^2 on Days 1 and 8 every 21 days.

Protocol documents:
Clinical trial NCT01015638
Conditions: Acne Vulgaris
Keywords: Healthy volunteers
Sponsor: Stiefel, a GSK Company
Start date: 2009-08-01; Completion date: 2009-09-01
Enrollment: 36 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a single-blind (blinded expert grader) study that will enroll 25-30 healthy volunteers without facial acne. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5% or clindamycin phosphate and benzoyl peroxide 2.5% and the other side of the face will remain non-treated to serve as a control.

Detailed description:
This is a single-blind (blinded expert grader), parallel group, randomized, half-face study being conducted at one clinical site. On 1 side of the face, the subject will apply 1 of the 2 test products, clindamycin and benzoyl peroxide 5%) or clindamycin and benzoyl peroxide 2.5%) and the other side of the face will remain non-treated to serve as a control. Approximately 25-30 male and female healthy subjects without facial acne, aged 18 to 45, will be randomly assigned to each product.

The eligible subjects (screened 3 days prior to randomization) who qualify will be entered into a 2-week treatment phase. The once-daily applications for the clindamycin and benzoyl peroxide 5%and clindamycin phosphate and benzoyl peroxide 2.5%) will be supervised at the site, Monday through Friday of each week. Subjects will apply the study product at home on Saturdays and Sundays and record the times of application on a diary card.

A blinded expert grader will rate comparative product tolerance in terms of erythema and dryness on each week day (excluding Saturdays and Sundays) during the study before study product is applied.

Instruments will be used to measure transepidermal water loss (TEWL) to assess skin moisture in order to evaluate product mildness. Instrumentation measurements of skin surface conductance will be utilized to evaluate product performance in terms of level of skin hydration.

Subjects will complete questionnaires and all adverse events will be recorded.

Arms: arm 1: Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel. arm 2: Once Daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel.
Interventions: intervention 1: Clindamycin and BPO 5% gel intervention 2: Clindamycin phosphate and benzoyl peroxide 2.5% gel.
Intervention descriptions: intervention 1: Once-daily applications, to the randomized side of the face either left or right, of clindamycin and benzoyl peroxide (BPO) 5% gel. intervention 2: Once daily application of clindamycin phosphate and benzoyl peroxide (BPO) 2.5% gel

Protocol documents:
Clinical trial NCT01092702
Conditions: Tobacco Abstinence
Keywords: Tobacco Dependence Smoking Tobacco Cessation
Sponsor: Mayo Clinic
Start date: 2008-04-01; Completion date: 2009-09-01
Enrollment: 32 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The goal of this proposal is to explore the potential effectiveness of varenicline to treat tobacco dependence among recovering alcoholic smokers who, as a group, are at high risk for tobacco-caused morbidity and mortality. In this open-label phase II clinical trial, we are proposing to enroll 32 recovering alcoholic smokers who are motivated to stop smoking. After the initial up titration of varenicline in week 1, all 32 subjects will receive a total of 2 mg/day of varenicline for 12 weeks. In addition to receiving varenicline, all subjects will receive brief behavioral counseling and our standard intervention at each visit during participation in the study.

Detailed description:
This is an open-label, phase II clinical trial. All subjects will be screened for study eligibility after providing informed consent. During the clinic screen visit the subjects are informed of the study, the study informed consent is signed by the subject and staff member, a series of screening tests are conducted and screening criteria are reviewed. Once enrolled in study, the subject will return for a face to face clinic visit weekly for the first 4 weeks (visits 3-6) and then biweekly for the last 8 weeks(visits 7-10). Target quit day is the day after visit 3 (week 1 visit).

During the first week varenicline will be started at a dose of 0.5 mg once daily for days 1-3; then 0.5 mg twice daily for days 4-7. Target quit date is set at day 8. Varenicline is then continued for weeks 2-12 at a dose of 1 mg twice daily.

Subjects will return weekly for 4 weeks then bi-weekly for the remaining 8 weeks. The study end-date will be Week 12, which is also the end-of-treatment date.

Arms: arm 1: Everyone on study will receive Varenicline daily for 12 weeks
Interventions: intervention 1: Varenicline
Intervention descriptions: intervention 1: During the first week varenicline will be started at a dose of 0.5 mg once daily for days 1-3; then 0.5 mg twice daily for days 4-7. Target quit date is set at day 8. Varenicline is then continued for weeks 2-12 at a dose of 1 mg twice daily.

Protocol documents:
Clinical trial NCT01098071
Conditions: Adenoids
Sponsor: Organon and Co
Start date: 2008-08-01; Completion date: 2009-09-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To document the short term \& long term effect of treatment with Nasonex (mometasone furoate nasal spray) in moderate to severe adenoids hypertrophy (which cause \> 50% obstruction of the posterior choanae).

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: mometasone furoate nasal spray
Intervention descriptions: intervention 1: One spray (50 mcg per spray) in each nostril once daily (100 mcg daily) for 3 months

Protocol documents:
Clinical trial NCT01117766
Conditions: Neuropathic Pain
Keywords: Methodology Quantitative Sensory Testing Neuropathies Pain Pregabalin
Sponsor: Pfizer
Start date: 2006-12-01; Completion date: 2009-09-01
Enrollment: 31 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Conventional pain efficacy measures such as Visual Analogue Scores (VAS) are often unable to detect treatment efficacy in small-scale clinical trials. Combining conventional pain efficacy measures with quantitative sensory testing (QST) may provide more sensitive and informative outcome measures in clinical trials.

Detailed description:
Methodology to assess reproducibility and sensitivity of quantitative sensory testing

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: Placebo
Intervention descriptions: intervention 1: Dose titration according to following regimen: 75mg BID for 3 days; 150mg for 4 days; 225mg BID for 4 days; 300mg BID for 17 days. Dose reduced for renally impaired patients intervention 2: BID dosing for 28 days

Protocol documents:
Clinical trial NCT01186939
Conditions: Myelodysplastic Syndromes
Keywords: Myelodysplastic Syndromes MDS
Sponsor: Celgene
Start date: 2007-04-01; Completion date: 2009-09-01
Enrollment: 40 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional efficacy data.

Detailed description:
At the conclusion of study AZA PH GL 2003 CL 001 (NCT00071799), eligible participants could be enrolled in an optional extension phase in order to continue treatment with azacitidine until it became commercially available; the continued treatment was for ethical and safety reasons only and not to provide additional efficacy data.

During the extension phase, participants were treated based on 28-day cycles and monitored for hematologic, nonhematologic, and renal toxicities. Recommended monitoring procedures included complete blood count with differential and platelets at least once each cycle prior to dosing and as needed, bone marrow biopsy and aspirate as clinically indicated, and additional tests or more frequent monitoring at the investigator's discretion based on the patient's clinical status. The azacitidine dose could be modified for toxicities. Laboratory data were not collected during the extension phase.

Arms: arm 1: Azacitidine (study drug) plus best supportive care.
Interventions: intervention 1: Azacitidine
Intervention descriptions: intervention 1: Azacitidine was injected subcutaneously (SC) for 7 days. The 7-day dosing was repeated every 28 days with dose adjustments allowed. The initial dose during the primary study was 75mg/m\^2/day.

Protocol documents:
Clinical trial NCT01229449
Conditions: Post-operative Pain
Keywords: Dental pain Ibuprofen Acetaminophen Nurofen Plus® Panadeine® Extra Paracetamol
Sponsor: Reckitt Benckiser LLC
Start date: 2009-01-01; Completion date: 2009-09-01
Enrollment: 678 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The objective is to assess the efficacy and tolerability of a combination of 400 mg ibuprofen plus 1000 mg acetaminophen, 200 mg ibuprofen plus 500 mg acetaminophen compared with Nurofen Plus® and Panadeine® Extra.

Detailed description:
RB has developed a fixed-dose combination of ibuprofen and acetaminophen (paracetamol). Since the pharmacological actions of ibuprofen and acetaminophen (paracetamol) differ in their site and mode of action, the combination would be expected to be more effective than either active alone, given that pain is multi-factorial with different mediators.

The purpose of this study was to compare the efficacy and tolerability of ibuprofen/acetaminophen (paracetamol) combination with leading market analgesics.

The efficacy and tolerability was assessed in terms of total analgesic effect, peak analgesic effect, onset and duration of action and the subject's overall assessment of the study medication.

Arms: arm 1: One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet arm 2: Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg arm 3: Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®) arm 4: Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra) arm 5: Two placebo tablets
Interventions: intervention 1: Ibuprofen/acetaminophen intervention 2: Ibuprofen/acetaminophen (higher dose) intervention 3: Nurofen Plus® intervention 4: Panadeine® Extra intervention 5: Placebo
Intervention descriptions: intervention 1: One tablet of ibuprofen 200 mg plus acetaminophen 500 mg and one placebo tablet, single dose taken orally with 300 ml water intervention 2: Two tablets of ibuprofen 200 mg plus acetaminophen 500 mg, single dose taken orally with 300 ml water intervention 3: Two tablets ibuprofen 200mg plus codeine 12.8mg (Nurofen Plus®), single dose taken orally with 300 ml water intervention 4: Two tablets acetaminophen 500 mg plus codeine 15 mg (Panadeine® Extra), single dose taken orally with 300 ml water intervention 5: Two placebo tablets, single dose taken orally with 300 ml water

Protocol documents:
Clinical trial NCT01436526
Conditions: Therapeutic Equivalency
Keywords: Bioequivalence
Sponsor: Bayer
Start date: 2009-08-01; Completion date: 2009-09-01
Enrollment: 28 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The drug investigated in this study is Rivaroxaban, a novel, once-daily, oral anticoagulant for the prevention (prophylaxis) of deep vein thrombosis (DVT) which may lead to a pulmonary embolism (PE) in people undergoing knee or hip replacement surgery.

The purpose of this study is to establish bioequivalence of 2 immediate-release tablet treatments with Rivaroxaban: 2\*5 mg tablets and 1\*10 mg tablet will be given to healthy volunteers under fasting conditions; they will be administered as single oral doses in 2 periods. Both periods will be separated by a 7-day washout phase. Thus, the bioequivalence represents the primary study objective. As a secondary objective, this treatment will be assessed in terms of safety and tolerability.

Bioequivalence will be evaluated and verified on the basis of pharmacokinetic data. Blood samples of the volunteers will be taken at specific points in time; these samples will be analyzed using various statistical methods to establish pharmacokinetic characteristics required to compare the 2 treatments. The planned treatments with Rivaroxaban will be considered bioequivalent if specific criteria defined in the study protocol are met.

The study will be conducted in one center in Germany. 28 subjects meeting the inclusion criteria will participate. They will be treated according to a single-dose, randomized, 2-way cross-over, non-placebo-controlled design.

Detailed description:

Arms: arm 1: Single oral dose of rivaroxaban administered under fasting conditions 2\*5 mg tablet in first intervention period and 1\*10 mg tablet in second intervention period (after washout period) arm 2: Single oral dose of rivaroxaban administered under fasting conditions 1\*10 mg tablet in first intervention period and 2\*5 mg tablet in second intervention period (after washout period)
Interventions: intervention 1: Rivaroxaban (Xarelto, BAY59-7939) intervention 2: Rivaroxaban (Xarelto, BAY59-7939)
Intervention descriptions: intervention 1: Single oral dose of rivaroxaban administered under fasting conditions 2\*5 mg tablet in first intervention period and 1\*10 mg tablet in second intervention period (after washout period) intervention 2: Single oral dose of rivaroxaban administered under fasting conditions 1\*10 mg tablet in first intervention period and 2\*5 mg tablet in second intervention period (after washout period)

Protocol documents:
Clinical trial NCT01541371
Conditions: Schizophrenia
Keywords: Schizophrenia Paliperidone extended-release tablets
Sponsor: Xian-Janssen Pharmaceutical Ltd.
Start date: 2008-07-01; Completion date: 2009-09-01
Enrollment: 405 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the effectiveness of paliperidone extended-release (ER; designed to slowly release a drug in the body over an extended period of time) tablets in participants with schizophrenia (psychiatric disorder with symptoms of emotional instability, detachment from reality, often with delusions \[a false belief held in the face of strong differing evidence, especially as a symptom of psychiatric disorder\] and hallucinations \[imagining things\], and withdrawal into the self) who were not satisfied with other prior antipsychotics (agents that control agitated psychotic behavior, alleviate acute psychotic states, reduce psychotic symptoms, and exert a quieting effect; olanzapine, quetiapine and risperidone) they had been taking. The safety and tolerability of paliperidone ER tablets will also be assessed.

Detailed description:
This is an open label (all people know the identity of the intervention), prospective (study following participants forward in time), non-randomized (the study drug is not assigned by chance, participants may choose which group they want to be in, or they may be assigned to the groups by the researchers), single-arm (getting one dose of medicine) and multi-center (when more than one hospital or medical school team work on a medical research study) study designed to determine the efficacy, tolerability and safety of flexible dosage of paliperidone ER tablets in treatment of participants with schizophrenia not satisfied with other prior antipsychotics. The duration of the study will be 12 weeks. All participants will be given paliperidone ER 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks; initial dose for paliperidone ER will be 6 mg/day. The primary objective will be to evaluate the efficacy of treatment with paliperidone ER using Positive and Negative Symptom Scale (PANSS) total scores. Participants safety and tolerability will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Paliperidone ER
Intervention descriptions: intervention 1: Paliperidone Extended Release (ER) 3 milligram (mg) or 6 mg or 9 mg or 12 mg oral (by mouth) tablets depending on Investigator's discretion once daily for 12 weeks.

Protocol documents: