ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT01222091
Conditions: Hyperalgesia
Sponsor: Stanford University
Start date: 2009-02-01; Completion date: 2011-06-01
Enrollment: 10 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
This research study explores whether a beta-blocker (propranolol) can prevent a person from becoming more sensitive to pain after administration of an opioid (remifentanil). Beta blockers inhibit the sympathetic (fight or flight) response and are often used to treat angina and high blood pressure. In a previous study in human volunteers, the investigators demonstrated an increased sensitivity to pain after a 60-minute infusion of the opioid remifentanil. The goal of this study is to identify a possible inhibitor of this phenomenon.

Detailed description:
Recent evidence suggests that opioid therapy may cause a biphasic response, i.e. initial pain relief followed paradoxically by a longer lasting hypersensitivity to pain. Recent genetic analysis in mice suggests that beta adrenergic receptor antagonists reduce opiate-induced hyperalgesia (OIH). The purpose of this study is to determine the analgesic and antihyperalgesic properties of the beta-blocker propranolol on remifentanil-induced hypersensitivity in humans.

The investigators want to determine the analgesic and antihyperalgesic properties of the beta-blocker propranolol on remifentanil-induced hypersensitivity in humans. The investigators hope to learn whether the administration of beta-blocker propranolol will significantly diminish the hyperalgesic response after administration of an opioid.

The primary outcome measure for this study is change in size (area) of secondary hyperalgesia after cessation of remifentanil infusion, a measure of OIH.

Arms: arm 1: Propranolol, a beta blocker, or placebo to match, will be given to test whether or not it could modulate the expression of remifentanil-induced postinfusion hyperalgesia (RPH) during two pain test including: mechanically evoked pain to map the size of the hyperalgesic skin region caused by electrical stimulation and heat pain. arm 2: Propranolol, a beta blocker, or placebo to match, will be given to test whether or not it could modulate the expression of remifentanil-induced postinfusion hyperalgesia (RPH) during two pain test including: mechanically evoked pain to map the size of the hyperalgesic skin region caused by electrical stimulation and heat pain.
Interventions: intervention 1: Propranolol intervention 2: Placebo to Match Propranolol intervention 3: Remifentanil
Intervention descriptions: intervention 1: Propranolol administered intravenously, initially set to target plasma concentration of 5 ng/mL, titrated upward in 5 ng/mL intervals until a final concentration of 15 ng/mL is achieved. intervention 2: None intervention 3: Remifentanil administered intravenously at a plasma concentration of 3 ng/mL.

Protocol documents:
Clinical trial NCT01222520
Conditions: Hypertension
Sponsor: Boehringer Ingelheim
Start date: 2010-10-01; Completion date: 2011-06-01
Enrollment: 174 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
If a patient cannot have his or her blood pressure controlled with telmisartan 80 mg, an antihypertensive drug from different class should be started concomitantly.

In the Japanese 3x3 factorial trial of telmisartan and hydrochlorothiazide in essential hypertension patients whose diastolic blood pressure (DBP) are equal or more than 95 mmHg, the DBP control rate (less than 90 mmHg) after 8 weeks treatment of the telmisartan 80 mg monotherapy group (66 patients) was 41.5%. There should be medical needs of the telmisartan 80 mg and amlodipine 5 mg fixed dose combination because some patients cannot have his or her blood pressure controlled with telmisartan 80 mg.

Thus, this clinical trial is being conducted to evaluate the antihypertensive effect and safety of a fixed-dose combination (FDC) drug of 2 antihypertensive agents with different pharmacological effects, telmisartan 80 mg and amlodipine 5 mg (T80/A5 mg), compared with telmisartan 80 mg (T80 mg) monotherapy in Japanese patients with essential hypertension who fail to respond adequately to treatment with the maximum dose of telmisartan 80 mg monotherapy. In this trial, a multi-centre, randomised, double-blind, double-dummy, active-controlled, parallel group comparison method is employed.

Detailed description:

Arms: arm 1: once a daily arm 2: once a daily
Interventions: intervention 1: Telmisartan and amlodipine intervention 2: Telmisartan
Intervention descriptions: intervention 1: Telmisartan 80 mg and amlodipine 5 mg once a daily intervention 2: 80 mg once a daily

Protocol documents:
Clinical trial NCT01231334
Conditions: Acne Vulgaris
Sponsor: Allergan
Start date: 2010-08-01; Completion date: 2011-06-01
Enrollment: 286 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
A study comparing the topical application of Aczone® plus Differin® versus Duac® plus Differin® in patients with severe facial acne (facial acne vulgaris).

Detailed description:

Arms: arm 1: Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks. arm 2: Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks.
Interventions: intervention 1: Dapsone plus Adapalene intervention 2: Clindamycin/benzoyl peroxide plus Adapalene
Intervention descriptions: intervention 1: Dapsone (Aczone® Gel 5%) applied to entire face in the morning. Adapalene (Differin® 0.3% Gel)followed by Dapsone (Aczone® Gel 5%) applied to entire face in the evening. Daily treatment for 12 weeks. intervention 2: Clindamycin/benzoyl peroxide (Duac® Topical Gel)applied to entire face in the morning. Adapalene (Differin® 0.3% Gel) applied to entire face in the evening. Daily treatment for 12 weeks

Protocol documents:
Clinical trial NCT01232127
Conditions: HIV
Sponsor: Bristol-Myers Squibb
Start date: 2011-02-01; Completion date: 2011-06-01
Enrollment: 25 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess the effects of famotidine, given twice daily, on atazanavir administered with ritonavir and tenofovir in HIV-infected participants.

Detailed description:
This protocol was designed to compare the pharmacokinetic parameters of atazanavir administered as atazanavir/ritonavir, 400/100 mg once daily (QD), plus famotidine, 20 mg and 40 mg twice daily, with the parameters found at the usual clinical dose of atazanavir/ritonavir, 300/100 mg QD, without famotidine in HIV-infected participants receiving tenofovir disoproxil fumarate and at least 1 other nucleoside reverse transcriptase inhibitor.

Arms: arm 1: The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs. arm 2: FAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs. arm 3: FAM=famotidine. The protocol required that participants enrolled in this study already be receiving atazanavir, ritonavir, TDF, and 1 or more NRTIs.
Interventions: intervention 1: Atazanavir intervention 2: Atazanavir intervention 3: Ritonavir intervention 4: Ritonavir intervention 5: Tenofovir (TDF) intervention 6: Tenofovir (TDF) intervention 7: Nucleoside Reverse Transcriptase Inhibitor (NRTI) intervention 8: Nucleoside Reverse Transcriptase Inhibitor (NRTI) intervention 9: Famotidine (FAM) intervention 10: Famotidine (FAM)
Intervention descriptions: intervention 1: Capsule, oral, 300 mg, once daily, 10 days intervention 2: Capsule, oral, 400 mg, once daily, 7 days intervention 3: Capsule, oral, 100 mg, once daily, 10 days intervention 4: Capsule, oral, 100 mg, once daily, 7 days intervention 5: Capsule, oral, 300 mg, once daily, 10 days intervention 6: Capsule, oral, 300 mg, once daily, 7 days intervention 7: Oral, 10 days intervention 8: Oral, 7 days intervention 9: Tablet, oral, 20 mg, twice daily, 7 days intervention 10: Tablet, oral, 40 mg, twice daily, 7 days

Protocol documents:
Clinical trial NCT01236768
Conditions: Contraception
Keywords: Contraceptive
Sponsor: Agile Therapeutics
Start date: 2010-10-01; Completion date: 2011-06-01
Enrollment: 407 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of the study is to evaluate the efficacy and safety of a low dose transdermal contraceptive delivery system containing ethinyl estradiol and levonorgestrel.

Detailed description:
Comparative evaluation of AG200-15 versus OC with regard to safety, contraceptive efficacy, hormone related adverse events, lipid profile, cycle control (bleeding pattern), subject compliance and serum concentrations of EE and LNG. To evaluate TCDS wearability (including adhesion).

Arms: arm 1: Thin transdermal contraceptive delivery system (TCDS) that gives systemic exposure of levonorgestrel (LNG) and ethinyl estradiol (EE) arm 2: oral contraceptive containing 150mcg of LNG and 30mcg of EE
Interventions: intervention 1: AG200-15 intervention 2: Levora
Intervention descriptions: intervention 1: Contraception; AG200-15 is applied and replaced every 7 days for 3 weeks, followed by a 1-week "patch free" period. intervention 2: One tablet of Levora will be taken each day for a 28 day cycle.

Protocol documents:
Clinical trial NCT01249651
Conditions: Heartburn
Keywords: Patients, Single
Sponsor: AstraZeneca
Start date: 2010-11-01; Completion date: 2011-06-01
Enrollment: 101 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Administration of esomeprazole 40 mg to subjects who still had heartburn after receiving rabeprazole 20 mg once daily for 4 to 8 weeks will result in statistically significant improvement of heartburn after 8-week treatment.

Detailed description:

Arms: arm 1: One arm: esomeprazole 40 mg
Interventions: intervention 1: esomeprazole 40 mg
Intervention descriptions: intervention 1: esomeprazole 40 mg once daily, 8 weeks

Protocol documents:
Clinical trial NCT01255423
Conditions: Ankle Sprain
Keywords: Ankle sprain, soft tissue injury
Sponsor: Novartis
Start date: 2010-11-01; Completion date: 2011-06-01
Enrollment: 206 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to evaluate the efficacy of Diclofenac Sodium Topical (DSG) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Diclofenac sodium topical gel 1% intervention 2: Placebo
Intervention descriptions: intervention 1: Diclofenac sodium topical gel 1%, 4 times daily intervention 2: Placebo, 4 times daily

Protocol documents:
Clinical trial NCT01256476
Conditions: Primary Dyslipidemia Mixed Dyslipidemia
Sponsor: Kowa Research Institute, Inc.
Start date: 2010-10-01; Completion date: 2011-06-01
Enrollment: 328 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Randomized, double-blind, double-dummy, 12-week, active-controlled study of pitavastatin 4 mg daily(QD) vs. pravastatin 40 mg daily(QD) in subjects with primary hyperlipidemia or mixed dyslipidemia.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: pitavastatin intervention 2: pravastatin
Intervention descriptions: intervention 1: pitavastatin 4 mg once daily (QD) intervention 2: Pravastatin 40 mg once daily (QD)

Protocol documents:
Clinical trial NCT01276288
Conditions: Diabetes Mellitus, Type 2
Sponsor: Boehringer Ingelheim
Start date: 2011-01-01; Completion date: 2011-06-01
Enrollment: 23 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of the study is to investigate the effect of BI 10773, hydrochlorothiazide and torasemide on changes in serum and urine electrolytes. Furthermore the pharmacodynamic and pharmacokinetic interactions between BI 10773 and diuretics should be assessed.

Detailed description:

Arms: arm 1: administration of BI 10773 once daily for 5 days (20 patients) arm 2: administration of hydrochlorothiazide (HTC) once daily for 4 days (10 patients) arm 3: administration of torasemide (TOR) once daily for 4 days (10 patients) arm 4: administration of BI 10773 + HTC once daily for 5 days (10 patients) arm 5: administration of BI 10773 + TOR once daily for 5 days (10 patients)
Interventions: intervention 1: BI 10773 intervention 2: hydrochlorothiazide intervention 3: torasemide intervention 4: BI 10773 intervention 5: torasemide intervention 6: BI 10773 intervention 7: hydrochlorothiazide
Intervention descriptions: intervention 1: multiple oral doses intervention 2: multiple oral doses intervention 3: multiple oral doses intervention 4: multiple oral doses intervention 5: multiple oral doses intervention 6: multiple oral doses intervention 7: multiple oral doses

Protocol documents:
Clinical trial NCT01280266
Conditions: Raynaud Phenomenon
Keywords: Pathological Conditions Signs and Symptoms Blood circulation
Sponsor: Seoul National University Hospital
Start date: 2011-01-01; Completion date: 2011-06-01
Enrollment: 29 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The prevalence of Raynaud phenomenon (RP), a reversible vaso-constriction with skin discoloration, is 5-10% in general population. Often conventional measures such as warming up or minimizing exposure to cold are not enough and many patients require treatment with a vasodilator therapy. A recent study showed a good efficacy and safety profile of sildenafil, a selective inhibitor of cGMP specific phosphodiesterase type 5 (PDE5) in RP.

Here, the investigators aim to examine the efficacy and safety of Udenafil, a newer PDE5 inhibitor, as compared to amlodipine, a well known calcium channel blocker, in the treatment of secondary RP in Korean patients.

Detailed description:

Arms: arm 1: Amlodipine 10mg PO QD for 4 weeks, washout period, then Udenafil 100mg PO QD for 4 weeks arm 2: Udenafil 100mg PO QD for 4 weeks, washout period, then Amlodipine 10mg PO QD for 4 weeks
Interventions: intervention 1: Udenafil or Amlodipine
Intervention descriptions: intervention 1: Amlodipine 10mg daily then Udenafil 100 mg daily OR Udenafil 100 mg daily then Amlodipine 10mg daily

Protocol documents:
Clinical trial NCT01283555
Conditions: Microbicide Applicator
Keywords: Microbicide, Applicator, Safety
Sponsor: PATH
Start date: 2011-01-01; Completion date: 2011-06-01
Enrollment: 25 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The primary objective of this study is to compare the effect of two vaginal applicators, delivering the candidate microbicide Tenofovir, on symptoms and signs of irritation of the external genitalia, cervix and vagina as seen on colposcopy after seven days of twice daily use.

The secondary objectives are to:

1. Evaluate and compare the dosing accuracy and precision of the user-filled applicator and pre-filled applicator with the candidate microbicide, Tenofovir.
2. Compare the acceptability of the user-filled applicator with the pre-filled applicator.

Detailed description:

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Tenofovir
Intervention descriptions: intervention 1: Delivered using prefilled and user-filled applicator

Protocol documents:
Clinical trial NCT01292642
Conditions: Cannabis Dependence Nicotine Dependence
Keywords: cognitive behavioral therapy nicotine dependence cannabis dependence smoking cessation nicotine replacement therapy
Sponsor: Mclean Hospital
Start date: 2009-08-01; Completion date: 2011-06-01
Enrollment: 12 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The investigators are conducting a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a Cognitive Behavioral Therapy (CBT) intervention. The investigators aim to develop a feasible 10-week integrated CBT intervention for the treatment of concurrent marijuana dependence and nicotine dependence. The investigators hypothesize that the CBT intervention, in conjunction with Nicotine Replacement Therapy (NRT) in the form of a transdermal nicotine patch, will reduce the use of marijuana and nicotine.

Detailed description:
The investigators will conduct a Stage 1 pilot feasibility study at McLean Hospital to develop and refine a Cognitive Behavioral Therapy (CBT) intervention. Twelve subjects (50% female, ages 18-65) who meet Diagnostic and Statistical Manual of Mental Disorders 4th edition (DSM-IV) criteria for both marijuana and nicotine dependence and seek treatment to stop using both marijuana and tobacco will receive individual CBT aimed at treating both disorders, as well as Nicotine Replacement Therapy (NRT) in the form of a transdermal nicotine patch. Subjects will start with a 21-mg nicotine patch for 6 weeks, followed by a taper to a 14-mg nicotine patch for 2 weeks and, finally, a 7-mg nicotine patch for 2 weeks. Others will start with a 14-mg patch for 8 weeks followed by a 7-mg patch for 2 weeks. All participants will receive 10 weeks of 1-hour weekly CBT with an experienced clinician. Follow-up visits, scheduled at 4, 6, 8, and 10 weeks, will evaluate of the durability of treatment effects on drug use and psychosocial outcomes.

Arms: arm 1: Cognitive behavioral therapy (CBT) plus transdermal patch nicotine replacement therapy (NRT) to treat co-occurring nicotine and cannabis dependence during a 10-week study.
Interventions: intervention 1: Cognitive Behavioral Therapy intervention 2: Nicotine Replacement Therapy
Intervention descriptions: intervention 1: individual CBT once weekly, 50 minutes, for 10 weeks intervention 2: 1. 21 mg patch for 6 weeks, 14 mg patch for 2 weeks, then 7 mg patch for 2 weeks
2. 14 m g patch for 8 weeks, then 7 mg patch for 2 weeks

Protocol documents:
Clinical trial NCT01294241
Conditions: Inherited Epidermolysis Bullosa
Keywords: Epidermolysis bullosa Wound healing Epithelialization
Sponsor: Birken AG
Start date: 2010-11-01; Completion date: 2011-06-01
Enrollment: 10 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study was to compare intra-individually the reepithelialization of skin lesion(s) in inherited Epidermolysis bullosa (either 1 wound ≥10 cm2 and ≤200 cm2 in size divided in 2 equal halves or 2 comparable wounds of ≥5 cm2 each) treated with Oleogel-S10 and non-adhesive wound dressing versus non-adhesive wound dressing only.

Detailed description:
This study was designed as an open-label, prospective, controlled, blindly evaluated, monocentric phase II case series documentation in patients with inherited Epidermolysis bullosa (EB). The investigator either identified 1 EB wound ≥10 cm2 and ≤200 cm2 in size and divided it into 2 halves or selected 2 comparable wounds of ≥5 cm2 each. One (half of the) EB wound was treated with Oleogel-S10 and non-adhesive wound dressing. The other wound (half) was covered with a non-adhesive wound dressing only (Mepilex®) as control. Wound dressings were changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'. This was an open-label study. The investigator, the participant, and the sponsor knew the identity of the treatment. Two independent experts were blind to treatment and assessed efficacy based on chronological series of cropped and coded photographs by wound (half) that were taken before start of treatment, during wound dressing changes and at the end of treatment on Day 14/Day 28.

Arms: arm 1: The eligible wound (half) was topically treated with Oleogel-S10 and covered with a non-adhesive wound dressing (Mepilex®) on Day 0. Wound dressings were changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'. arm 2: Mepilex® soft silicone faced polyurethane foam dressing was used as non-active comparator. The eligible wound (half) was covered with Mepilex® as control on Day 0. Wound dressings were changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.
Interventions: intervention 1: Oleogel-S10 intervention 2: Mepilex® soft silicone faced polyurethane foam dressing
Intervention descriptions: intervention 1: 1 cm or 125 µL or 115 mg Oleogel-S10 per cm2 wound area (corresponds to thickness of approximately 1 mm or 0.04 inch) every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'. intervention 2: Mepilex® soft silicone faced polyurethane foam dressing was changed about every 24 to 48 hours until discharge from hospital or until the end of treatment at Day 14 in 'recent wounds' or Day 28 in 'chronic wounds'.

Protocol documents:
Clinical trial NCT01295879
Conditions: Nephrolithiasis Urolithiasis Idiopathic Hypercalciuria Vitamin D Deficiency Disorder of Vitamin D
Keywords: Vitamin D insufficiency
Sponsor: New York Presbyterian Hospital
Start date: 2010-09-01; Completion date: 2011-06-01
Enrollment: 30 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
Vitamin D plays a critical role in maintaining bone health, as well as preventing cardiovascular disease, cancer, and various autoimmune diseases, such as diabetes. Vitamin D deficiency is very common in the United States and worldwide, and is now being increasingly recognized and treated. One group in which vitamin D deficiency may be particularly important is patients who have had kidney stones. These patients frequently have elevated levels of calcium in their urine, which is a common and important risk factor for calcium containing kidney stones. Because vitamin D increases absorption of calcium into the blood by the intestines, physicians may be reluctant to prescribe vitamin D therapy to patients with vitamin D deficiency if they also have kidney stones and high amounts of calcium in the urine. They are concerned about the possible risk of increasing the amount of calcium in the urine (and thereby increasing the risk of calcium stones occurring again). However, studies in patients without kidney stones, as well as studies in patients with high calcium levels in the urine, have demonstrated that giving vitamin D is effective and safe and does not increase calcium in the urine. Therefore, the investigators will study the effects of giving vitamin D on the amount of calcium in the urine in patients with a history of kidney stones and elevated calcium in the urine. The investigators will evaluate the safety of giving vitamin D to this particular group of patients.

Detailed description:
The investigators plan to conduct a clinic-based interventional study of 30 patients followed at outpatient urology clinics associated with New York Presbyterian Hospital (NYPH). The intervention is supplementation with oral ergocalciferol 50,000 IU per week for 8 weeks, and each participant will serve as his/her own control. The formulation, dose, and duration of vitamin D therapy is reflective of that which is given in routine clinical practice to patients with vitamin D deficiency. The outcome is the change in urinary calcium excretion.

Arms: arm 1: Subjects will take Ergocalciferol (vitamin D), 50,000 IU's orally per week for 8 weeks
Interventions: intervention 1: Ergocalciferol
Intervention descriptions: intervention 1: Ergocalciferol 50,000 IU's orally per week, for 8 weeks

Protocol documents: