ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT00733005
Conditions: Allergic Rhinitis
Sponsor: Organon and Co
Start date: 2008-07-01; Completion date: 2008-10-01
Enrollment: 324 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study seeks to prospectively demonstrate that Nasonex is better than placebo in relieving nasal congestion in patients with seasonal allergic rhinitis.

Detailed description:

Arms: arm 1: Mometasone furoate nasal spray 200 mcg QD (once per day) arm 2: Matching placebo nasal spray
Interventions: intervention 1: Mometasone furoate nasal spray (MFNS) intervention 2: Matching placebo nasal spray
Intervention descriptions: intervention 1: MFNS 50 mcg/spray: two sprays in each nostril once daily (ie, 200 mcg QD) for 15 days intervention 2: Matching placebo nasal spray: 2 sprays in each nostril once daily for 15 days

Protocol documents:
Clinical trial NCT00733226
Conditions: Asthma
Keywords: wheezing asthma childhood OM-85 BV Broncho-Vaxom
Sponsor: Kecioren Education and Training Hospital
Start date: 2007-08-01; Completion date: 2008-10-01
Enrollment: 80 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study is to determine whether OM-85 BV (Broncho-Vaxom)has any effect on respiratory infections, infection related wheezing attacks, beta-2 agonist use, duration of attacks and effect on serum cytokine levels.

Detailed description:
Context: Respiratory infections are the major cause of wheezing attacks in children with recurrent wheezing or asthma in preschool age. OM-85 BV is an bacteria lysate which has been proven to prevent respiratory infections about 40 percent in children.

Objective: To determine if using OM-85 BV diminish the number and duration of the respiratory infections and respiratory infection related wheezing attacks,beta-2 agonist and steroid use, and number and duration of hospitalizations in children with recurrent wheezing and asthma. And also to determine if OM-85 BV has any effect on serum cytokine levels after 6 months.

Study Design/Setting/Participants: A double-blind, randomized, controlled trial of OM-85 BV versus placebo for children 6 months to 6 years of age who have respiratory tract infection related recurrent wheezing attacks.

Intervention: Participants will receive either active Broncho-Vaxom or placebo for 3 months.

Study Measures: They follow up for 1 year for number and duration of wheezing attacks, number, type and duration of respiratory infections, number and duration of beta-2 agonist use, number and duration of steroid use and number and duration of hospitalizations. Serum cytokine levels will measure to determine if Broncho-Vaxom has any effect on serum cytokine levels (at the beginning of the trial and sixth months of the trial).

Arms: arm 1: The children received one capsule per oral, OM-85 BV (3.5 mg) per day for the first 10 consecutive days of each month for 3 consecutive months. arm 2: The children received one capsule per oral, placebo per day for the first 10 consecutive days of each month for 3 consecutive months.
Interventions: intervention 1: OM-85 BV (Broncho-Vaxom) intervention 2: OM-85 BV (placebo)
Intervention descriptions: intervention 1: 3.5 mg capsule, 1 capsule per day for first 10 day of the month, for 3 months intervention 2: 3.5 mg oral placebo capsule, 1 placebo capsule per day for first 10 days of the months for 3 months

Protocol documents:
Clinical trial NCT00734097
Conditions: Gastroesophageal Reflux Disease
Keywords: heartburn reflux proton pump inhibitor
Sponsor: AstraZeneca
Start date: 2007-11-01; Completion date: 2008-10-01
Enrollment: 314 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Esomeprazole 40 mg intervention 2: Physical Exam intervention 3: Quality of Life Questionnaires intervention 4: pregnancy test, if applicable
Intervention descriptions: intervention 1: Once a day intervention 2: every visit intervention 3: every visit intervention 4: as needed

Protocol documents:
Clinical trial NCT00741468
Conditions: Drug Interactions
Keywords: Drug-drug interactions DDI
Sponsor: Repros Therapeutics Inc.
Start date: 2008-07-01; Completion date: 2008-10-01
Enrollment: 18 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This study will assess possible drug-drug interactions with specific isoenzymes over a total study duration of 6-8 weeks. Blood samples collected pre and post-dose, and urine samples collected post dose will be analyzed.

Detailed description:
This is an open-label, multiple-dose, non-randomized study to assess the drug-drug interactions of Proellex® with cytochrome P450 isoenzymes in healthy female subjects. On Day 1, following an overnight fast and morning void of the bladder, subjects will be administered CYP probe drugs orally. Serial blood samples will be collected at pre-dose and post-dose. Subjects will be administered two Proellex® 25 mg capsules (50 mg total dose) at approximately 0800 hours on Day 2 and 0700 hours on Days 3 through 8. One hour after administration of Proellex® on Day 8, the five CYP probe drugs will be administered and blood and urine samples collected as on Day 1. Blood samples for the determination of plasma concentrations of CDB-4124 and its metabolite CDB-4453 will be collected at pre-dose (trough) on Days 6, 7, and 8 to determine if steady-state conditions have been achieved. Samples will also be collected on Day 8 at 1, 2, 8 and 24 hour after administration of Proellex® to determine the plasma concentrations of CDB-4124 and CDB-4453.

Arms: arm 1: Proellex 50 mg CYP1A2 probe CYP2C9 probe CYP2C19 probe CYP2D6 probe CYP3A4 probe
Interventions: intervention 1: Proellex intervention 2: CYP1A2 probe intervention 3: CYP2C9 probe intervention 4: CYP2C19 probe intervention 5: CYP2D6 probe intervention 6: CYP3A4 probe
Intervention descriptions: intervention 1: 2, 25 mg Proellex capsules administered daily intervention 2: Caffeine (200 mg) intervention 3: Tolbutamide (250 mg) intervention 4: Omeprazole (20 mg) intervention 5: Dextromethorphan (30 mg) intervention 6: Midazolam (2mg)

Protocol documents:
Clinical trial NCT00745901
Conditions: Contraception
Keywords: contraception bleeding cycle control
Sponsor: Ortho-McNeil Janssen Scientific Affairs, LLC
Start date: 2008-05-01; Completion date: 2008-10-01
Enrollment: 355 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The purpose of this study in healthy sexually active females is to evaluate the cycle control with norgestimate/ethinyl estradiol versus drospirenone/ethinyl estradiol.

Detailed description:
This is a randomized, open-label, active-controlled, multicenter study in healthy sexually active females to evaluate cycle control with norgestimate/ethinyl estradiol versus drospireneone/ethinyl estradiol. The Open-Label Treatment Phase will last for three 28-day cycles. Approximately 300 patients will be randomized in a 1:1 fashion according to a predetermined randomization schedule. Patients will be seen for a baseline visit (Visit 1) up to 35 days prior to dosing to obtain informed consent, have a physical examination including a breast exam, height and weight, vital signs, a Chlamydia test and a urine pregnancy test performed, and to give their medical history. Patients will be instructed to report bleeding data using an interactive voice response system (IVRS) based diary on a daily basis. Patients will be instructed to continue taking 1 pill each day for 3 cycles, record this information daily in the IVRS and to contact the study site if they have any questions or adverse events they would like to discuss. The final study visit (Visit 2) will occur on Day 8 after completing 3 cycles of study medication. Patients will be weighed, have vital signs performed, report any adverse events and or changes in concomitant medications, and complete the satisfaction questionnaire at the final visit. Safety will be assessed by physical examinations, adverse events, body weight and vital signs. Patients randomized to drospireneone/ethinyl estradiol and taking any medication that could increase serum potassium levels (as outlined in the Package Insert) will also have their potassium level checked during their first cycle of treatment (Days 15 to 28 of treatment). Three 28-day cycles of either norgestimate/ethinyl estradiol or drospirenone/ethinyl estradiol.

Interventions: intervention 1: Norgestimate/ethinyl estradiol; Drospirenone/ethinyl estradiol
Intervention descriptions: intervention 1: None

Protocol documents:
Clinical trial NCT00754130
Conditions: Diabetes Mellitus, Non-Insulin-Dependent
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-09-01; Completion date: 2008-10-01
Enrollment: 16 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The multiple dose study to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of MK-0941 in Japanese patients with Type 2 Diabetes.

Detailed description:

Arms: arm 1: Participants received Placebo during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 2: Participants received MK-0941 5 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 3: Participants received MK-0941 5 mg during Period 1 and MK-0941 20 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 4: Participants received Placebo during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 5: Participants received MK-0941 10 mg during Period 1 and Placebo during Period 2. There was a washout period of at least 8 days between the two treatment periods. arm 6: Participants received MK-0941 10 mg during Period 1 and MK-0941 40 mg during Period 2. There was a washout period of at least 8 days between the two treatment periods.
Interventions: intervention 1: Placebo intervention 2: MK-0941
Intervention descriptions: intervention 1: Placebo tablets before every meal (q.a.c) Treatment period is 5 days. intervention 2: MK-0941 5 mg tablets q.a.c.; 10 mg tablets q.a.c.; 20 mg tablets q.a.c.; or 40 mg tablets q.a.c. Treatment period is 5 days.

Protocol documents:
Clinical trial NCT00754624
Conditions: Type 2 Diabetes Mellitus
Sponsor: Mannkind Corporation
Start date: 2004-05-01; Completion date: 2008-10-01
Enrollment: 229 participants; Allocation: NON_RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
Safety Follow-Up Trial to PDC-INS-0008 and MKC-TI-005

Detailed description:
This is an uncontrolled study without comparator. Subjects were followed up to 4 years on Technosphere Insulin. Of 229 subjects 199 were exposed for ≥12 mo, 175 for ≥ 24 mo, 60 for ≥ 36 mo, 31 for ≥ 42 mo, \& 2 for 48 mo.

Arms: arm 1: Technosphere® Insulin Inhalation Powder
Interventions: intervention 1: Technosphere® Insulin Inhalation Powder and MedTone™ Inhaler
Intervention descriptions: intervention 1: Inhalation starting at 15, 30, or 60U doses and can be titrated up or down by 15U to a minimum of 15U or a maximum of 90U

Protocol documents:
Clinical trial NCT00761306
Conditions: Major Depressive Disorder
Keywords: Major Depressive Disorder Long-term Safety Open-label
Sponsor: H. Lundbeck A/S
Start date: 2007-06-01; Completion date: 2008-10-01
Enrollment: 74 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of the study is to evaluate long-term safety and tolerability of Vortioxetine over a period of 52 weeks in patients with Major Depressive Disorder (MDD) having completed 6-week acute treatment in study NCT00839423 / 11492A.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Vortioxetine (Lu AA21004)
Intervention descriptions: intervention 1: 5 or 10 mg/day; tablets; orally

Protocol documents:
Clinical trial NCT00768599
Conditions: Tinea Pedis Athlete's Foot
Keywords: Econazole Foam Quinnova
Sponsor: AmDerma
Start date: 2008-03-01; Completion date: 2008-10-01
Enrollment: 135 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a 6-week clinical study (4 weeks of treatment, once per day, plus a 2-week follow-up period) of a topical foam to treat athlete's foot. The active ingredient in the foam -- econazole nitrate 1% -- is the same active pharmaceutical ingredient in a cream that your doctor can currently prescribe to treat athlete's foot. This study will help to understand if the foam works the same as the cream to treat athlete's foot.

Detailed description:
Treating athlete's foot with a cream can leave a greasy, wet feeling on the foot that is uncomfortable to the user and messy on clothing and foot wear. A foam formulation that spreads easily and rubs-in easily that is as effective as the (reference) cream formulation in treating athlete's foot would be a benefit to the user. This study is designed to substantiate a clinical bridge between econazole nitrate foam 1% and econazole nitrate cream 1% based on clinical outcome, safety, and pharmacokinetic data. The study is (foam) vehicle-controlled and is randomized 1 to 1 to 1 (foam:cream:vehicle).

Arms: arm 1: Econazole Nitrate Cream 1% arm 2: Econazole Nitrate Foam 1% arm 3: Vehicle Foam
Interventions: intervention 1: Econazole Nitrate Cream 1% intervention 2: Econazole Nitrate Foam 1% intervention 3: Vehicle Foam
Intervention descriptions: intervention 1: Topical cream, applied once daily for 4 weeks. intervention 2: Topical foam, applied once daily for 4 weeks. intervention 3: Topical foam, applied once daily for 4 weeks.

Protocol documents:
Clinical trial NCT00783835
Conditions: Attention Deficit Hyperactivity Disorder
Keywords: Attention Deficit Hyperactivity Disorder Methylphenidate Concerta CONQoL
Sponsor: Janssen-Cilag Farmaceutica Ltda.
Start date: 2008-02-01; Completion date: 2008-10-01
Enrollment: 60 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to evaluate the efficacy, safety and to assess the impact of the treatment on quality of life of long-acting methylphenidate in adult participants with Attention Deficit Hyperactivity Disorder (ADHD). ADHD is a clinical condition beginning in childhood and is characterized by inadequate levels of attention, hyperactivity and impulsiveness.

Detailed description:
This is an open-label (all people know the identity of the intervention), multi-center (when more than one hospital or medical school team work on a medical research study), single arm study of multiple doses of long-acting methylphenidate in participants with ADHD. The study will consist of 2 phases; a screening phase and a treatment phase. The duration of participation in the study for an individual participant will be up to 12 weeks. Participants will be given 18 milligram (mg) of long-acting methylphenidate daily in the morning and titrated up (slow increase in drug dosage guided by participant's responses) to 36 mg per day (mg/day) on Day 8. Depending on response, tolerability and clinician's judgment, the dose could be escalated to the next dose level of 54 mg/day on Day 28 to a maximum of 72 mg/day on Day 56, until each participant achieved optimal dose. Participant's safety will be monitored throughout the study.

Arms: arm 1: None
Interventions: intervention 1: Long-Acting Methylphenidate
Intervention descriptions: intervention 1: Long-Acting Methylphenidate within the range of 18, 36, 54 and 76 milligram will be orally administered once daily up to Day 56.

Protocol documents:
Clinical trial NCT00799708
Conditions: Postmenopause
Keywords: Biomarkers of estrogen receptor beta activation
Sponsor: Merck Sharp & Dohme LLC
Start date: 2008-05-01; Completion date: 2008-10-01
Enrollment: 27 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will develop a model for the assessment of successful activation/engagement of estrogen receptor beta using salivary biomarkers.

Detailed description:

Arms: arm 1: Placebo arm 2: Estrace 0.5 mg arm 3: Estrace 2 mg
Interventions: intervention 1: Comparator: placebo intervention 2: Comparator: Estrace
Intervention descriptions: intervention 1: placebo capsule once daily for 7 days. intervention 2: Estrace 0.5 mg or 2 mg tablets once daily for 7 days.

Protocol documents:
Clinical trial NCT00823095
Conditions: Chronic Ulcer of Lower Extremity
Keywords: chronic cutaneous ulcers Nitric Oxide topically applied Biofilm Colonized chronic non-healing ulcers
Sponsor: Loma Linda University
Start date: 2005-12-01; Completion date: 2008-10-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
To determine the effects of topically applied ViaNOx-H for 8 hours daily for 2 weeks on the reduction of the bio-burden in biofilms on chronic non-healing wounds as recorded by measurements of wound size and wound culture.

Detailed description:
The primary goal of this study is to determine the effects of topically applied gaseous nitric oxide on the bio-burden of chronic non-healing wounds of the lower extremities. Reports will include:

* Comparisons of the demographics and diagnoses of those patients treated with ViaNOx-H.
* Tabulation as to the organisms found and the bio-burden as measured by counts (0 to +4).
* Tabulation of the number and types of adverse events during ViaNOx-H treatment.
* Comparisons of the response of different organisms to ViaNOx-H treatment.

Arms: arm 1: Topically applied Nitric Oxide for 8 hours daily for 2 weeks.
Interventions: intervention 1: Nitric Oxide
Intervention descriptions: intervention 1: Topically applied gaseous nitric oxide at 8 to 10 parts per million, for 8 hours each night for 14 nights.

Protocol documents:
Clinical trial NCT00829049
Conditions: Acne Vulgaris
Sponsor: Allergan
Start date: 2007-10-01; Completion date: 2008-10-01
Enrollment: 165 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Comparison of the safety and efficacy of Tazarotene Cream 0.1% compared with Adapalene Gel 0.3% in treating moderate to severe facial acne vulgaris

Detailed description:

Arms: arm 1: 1 pea-size amount, QD x 16 weeks arm 2: 1 pea-size amount, QD x 16 weeks
Interventions: intervention 1: Tazarotene Cream 0.1% intervention 2: Adapalene
Intervention descriptions: intervention 1: 1 pea-size amount, QD x 16 weeks intervention 2: 1 pea-size amount, QD x 16 weeks

Protocol documents:
Clinical trial NCT00940017
Conditions: Aspergillosis Candidemia
Keywords: PK fungal infection
Sponsor: Pfizer
Start date: 2008-09-01; Completion date: 2008-10-01
Enrollment: 24 participants; Allocation: RANDOMIZED; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to provide anidulafungin and voriconazole to healthy subjects to determine the drug concentration in the lung.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: anidulafungin and voriconazole
Intervention descriptions: intervention 1: Subjects will be admitted to the clinical research unit on Day 0. Subjects will receive anidulafungin intravenously in a loading dose of 200 mg on Day 1, followed by maintenance doses of 100 mg Q24h on Day 2 and Day 3. Simultaneously, using a separate intravenous access, subjects will receive voriconazole in a loading dose of 6 mg/kg Q12h on Day 1, followed by a maintenance dose of 4 mg/kg Q12h on Day 2, and a 4 mg/kg morning dose on Day 3.

Protocol documents:
Clinical trial NCT00978341
Conditions: Spinal Cord Injuries
Keywords: Clinical Trial Methodology study Neuropathic pain in Spinal cord injury patients Pain endpoints Crossover design
Sponsor: Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Start date: 2007-02-01; Completion date: 2008-10-01
Enrollment: 15 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The study is designed to assess if spinal cord injury patients have reduced pain after taking either pregabalin or placebo in a cross over design. Patients had either pain at the level of their injury or below the level of their injury.

Detailed description:
This methodology study was terminated on October 13, 2008 based on interim results for an exploratory, novel endpoint. The results of the primary analysis at the interim for N=12 patients showed results that generally favored pregabalin but were not statistically significant compared to placebo. Based on the estimated conditional power, this result is unlikely to change with full recruitment of N=24 patients and therefore the data monitoring committee recommended termination of the trial. The decision to terminate the trial was not based on any safety concerns.

Arms: arm 1: None arm 2: None
Interventions: intervention 1: Pregabalin intervention 2: Placebo for pregabalin
Intervention descriptions: intervention 1: Pregabalin 150mg capsules BID for 7.5 days intervention 2: Placebo capsules BID for 7.5 days

Protocol documents:
Clinical trial NCT01119222
Conditions: Healthy
Keywords: Cold pain methodology Healthy male volunteers gabapentin Diphenhydramine morphine
Sponsor: Pfizer
Start date: 2008-07-01; Completion date: 2008-10-01
Enrollment: 19 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
Human experimental pain models are useful in understanding the mechanisms underlying clinical pain conditions and can be used to test the analgesic efficacy of drugs used in the management of pain. Once established these models can be used as mechanism biomarkers in early development clinical studies to establish proof of mechanism for novel compounds. The cold pain model is a mechanistic pain biomarker with potential application in proof of mechanism studies. In this study we aim to set up this cold pain model at a Clinical Research Unit and demonstrate we can effectively screen subjects for this model and examine the effect of morphine, diphenhydramine, and gabapentin in the cold pain model.

Detailed description:
Cold pain methodology development

Arms: arm 1: None arm 2: None arm 3: None arm 4: None
Interventions: intervention 1: Gabapentin intervention 2: Diphenhydramine intervention 3: Morphine intervention 4: Placebo
Intervention descriptions: intervention 1: Capsule, single 1200mg dose intervention 2: Tablet, single 50mg dose intervention 3: IV, single 10mg dose intervention 4: Placebo formulations (Capsule, tablet, IV to match the active treatments and to be administered in a double-dummy fashion).

Protocol documents: