ds4dh/ct-dosing-errors huggingface dataset:
Clinical trial NCT02132117
Conditions: Erythema Rosacea
Sponsor: Allergan
Start date: 2014-06-01; Completion date: 2015-05-01
Enrollment: 445 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the safety and efficacy of oxymetazoline hydrochloride (HCl) cream 1.0% (AGN-199201) once daily compared to vehicle for the treatment of persistent moderate to severe facial erythema associated with rosacea.

Detailed description:

Arms: arm 1: Oxymetazoline HCL Cream 1.0% applied to the face once daily for 29 days. arm 2: Vehicle to Oxymetazoline HCL Cream applied to the face once daily for 29 days.
Interventions: intervention 1: Oxymetazoline HCL Cream 1.0% intervention 2: Vehicle to Oxymetazoline HCL Cream
Intervention descriptions: intervention 1: Oxymetazoline HCL Cream 1.0% (AGN-199201) applied to the face once daily for 29 days. intervention 2: Vehicle to Oxymetazoline HCL Cream (AGN-199201) applied to the face once daily for 29 days.

Protocol documents:
Clinical trial NCT02134717
Conditions: Sarcoidosis
Keywords: sarcoidosis CCR5 inhibition maraviroc
Sponsor: Kevin F. Gibson
Start date: 2014-01-01; Completion date: 2015-05-01
Enrollment: 3 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The study hypothesizes that inhibition of the receptor CCR5 by maraviroc will diminish inflammation in patients with sarcoidosis. Subjects with active sarcoidosis will first undergo bronchoscopy with bronchoalveolar lavage to recover lung immune cells for baseline analysis. They will then receive the drug maraviroc for 6 weeks duration. They will then undergo a repeat bronchoscopy with bronchoalveolar lavage to recover lung immune cells for analysis following maraviroc treatment.

Detailed description:
The investigators hypothesize that inhibition of CCR5 by maraviroc may have a beneficial immunomodulatory effect on the granulomatous inflammation of pulmonary sarcoidosis. The specific aim of this proposal is the investigate the effect of CCR5 inhibition on the trafficking of mononuclear cells to the lung, skin, peripheral blood in subjects with active sarcoidosis exposed to the CCR5 inhibitor, maraviroc. A second aim will be to isolate by cell sorting cluster of differentiation 4 (CD4)+CCR5+ T cells for amplified gene expression profiling before and after CCR5 inhibition, experiments the investigators believe will elucidate genes associated with downstream activation and inhibition of CCR5 receptor function.

Arms: arm 1: All subjects with active stage II sarcoidosis with or without skin disease will receive the drug maraviroc 300mg to be taken orally twice a day for 6 weeks duration.
Interventions: intervention 1: all subjects will receive maraviroc 300mg orally twice a day for 6 weeks intervention 2: Bronchoscopy with bronchoalveolar lavage intervention 3: venipunctures intervention 4: Skin biopsy
Intervention descriptions: intervention 1: None intervention 2: Bronchoscopy employs a flexible instrument that is inserted into the trachea and proximal airways after topical anesthesia. Bronchoalveolar lavage involves the instillation of saline solution through the bronchoscope into the airways followed by recovery under suction to collects lung fluid containing cells and proteins. intervention 3: Venipunctures will be performed at study entry, after two weeks, and at the end of the study to collect blood for research studies and safety laboratories. intervention 4: For subjects with sarcoidosis skin lesions, an optional skin biopsy specimen may be collected for research studies.

Protocol documents:
Clinical trial NCT02134756
Conditions: Performance Fatigue
Keywords: Supplement impact Performance Fatigue
Sponsor: University of South Florida
Start date: 2014-05-01; Completion date: 2015-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue.

The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and reduce subjective measures of fatigue.

Detailed description:
Compare an over-the-counter dietary supplement (NutraStem Active®) and placebo over a 30-day intervention on aerobic exercise performance and fatigue.

The hypothesis is that supplementation with NutraStem Active® improve aerobic performance and reduce subjective measures of fatigue.

The basic protocol includes baseline assessment of fitness and participation in a vigorous session of exercise immediately before and 30 days after consumption of the experimental supplement or placebo.

The exercise task is intended to be fatiguing and demanding but is not expected to create failure.

The supplement makes claims related to boosting exercise performance and reducing fatigue.

The study design will determine if these outcomes are in fact present in a group of healthy, young, and active adults.

The primary dependent measures are perceived exertion during exercise and levels of fatigue measured on multiple non-exercise days.

Arms: arm 1: Daily supplementation with NutraStem Active; 2 capsules per day for 28 days arm 2: Daily supplementation with placebo; 2 capsules per day for 28 days
Interventions: intervention 1: NutraStem Active intervention 2: NutraStem Placebo
Intervention descriptions: intervention 1: None intervention 2: None

Protocol documents:
Clinical trial NCT02161185
Conditions: Epilepsy
Keywords: Epilepsy seizure cluster acute repetitive seizures open-label intranasal Midazolam USL261 Upsher-Smith
Sponsor: UCB Biopharma S.P.R.L.
Start date: 2014-05-01; Completion date: 2015-05-01
Enrollment: 7 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: USL261
Intervention descriptions: intervention 1: 5 mg, intranasal dose for seizure cluster, may repeat as indicated by protocol

Protocol documents:
Clinical trial NCT02206776
Conditions: Obsessive-Compulsive Disorder
Keywords: OCD
Sponsor: New York State Psychiatric Institute
Start date: 2014-09-01; Completion date: 2015-05-01
Enrollment: 2 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Obsessive-compulsive disorder (OCD) is a common illness that causes significant distress and impairment. Currently, serotonin reuptake inhibitors (SRIs) are the only medications that are FDA-approved to treat OCD. Unfortunately, SRIs can take a long time to work (2-3 months), and even then they usually only partially reduce OCD symptoms. The present study, will test if intranasal ketamine is feasible to use and can reduce OCD symptoms significantly more than a comparison medication called midazolam. Therefore, you may or may not receive ketamine as part of this study. Results from this study will allow doctors and researchers to better understand if you and others with OCD may respond to this class of medications.

Detailed description:

Arms: arm 1: A single dose of intranasal midazolam up to 4 mg arm 2: A single dose of intranasal ketamine up to 50 mg
Interventions: intervention 1: Intranasal Ketamine intervention 2: Intranasal Midazolam
Intervention descriptions: intervention 1: A single dose of intranasal ketamine up to 50 mg intervention 2: A single dose of intranasal Midazolam up to 4 mg

Protocol documents:
Clinical trial NCT02219048
Conditions: Asthma
Keywords: Asthma Staged withdrawal of background therapy
Sponsor: Pfizer
Start date: 2014-11-01; Completion date: 2015-05-01
Enrollment: 51 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
The study proposes to evaluate the safety and efficacy of PF-03715455 in moderate to severe asthma when added to standard of care and during staged withdrawal of background therapy.

Detailed description:
Study terminated on 7th April 2015. The termination was due to business reasons. No safety or efficacy concerns contributed to the termination of the study

Arms: arm 1: Matched blinded placebo arm 2: PF-03715455
Interventions: intervention 1: Placebo intervention 2: PF-03715455
Intervention descriptions: intervention 1: 680 micrograms BID, Orally inhaled placebo for 12 weeks intervention 2: 680 micrograms BID, Orally inhaled PF-03715455 for 12 weeks

Protocol documents:
Clinical trial NCT02222896
Conditions: Surgery
Keywords: Preoperative surgical skin preparation
Sponsor: Medline Industries
Start date: 2014-08-01; Completion date: 2015-05-01
Enrollment: 347 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Evaluate the effects of Chlorhexidine Gluconate (CHG) cloth on the reduction of bacteria on the skin.

Detailed description:
Examine the antimicrobial cloth effects on normal flora bacteria of the abdomen and groin areas post CHG application.

Arms: arm 1: 2% CHG, single application arm 2: Excipients on cloth arm 3: Dynahex 2% CHG
Interventions: intervention 1: Chlorhexidine Gluconate intervention 2: Vehicle intervention 3: DynaHex-2
Intervention descriptions: intervention 1: 2% CHG solution on cloth intervention 2: Excipients of CHG product only intervention 3: 2% CHG solution

Protocol documents:
Clinical trial NCT02229461
Conditions: Hematology
Sponsor: Bayer
Start date: 2015-02-01; Completion date: 2015-05-01
Enrollment: 117 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To determine if administration of naproxen sodium 220 mg maintains the platelet inhibitory effect of a low dose Immediate Release Aspirin (IR ASA) regimen.

Detailed description:

Arms: arm 1: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg once daily (qd) in parallel with naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. arm 2: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. arm 3: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 8 hours after naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. arm 4: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd. A 3-day IR ASA 81 mg qd Run-Out period was followed. arm 5: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes before naproxen sodium (Aleve, BAY117031) 220 mg qd for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed. arm 6: Confirmed eligible participants were randomized to be administered immediate release acetylsalicylic acid (IR ASA, Aspirin, BAYE4465) 81 mg qd 30 minutes after first dose of naproxen sodium (Aleve, BAY117031) 220 mg, followed by second dose of naproxen sodium 220 mg 12 hours after first dose, for 10 consecutive days. A 3-day IR ASA 81 mg qd Run-Out period was followed.
Interventions: intervention 1: Naproxen Sodium (Aleve, BAY117031) intervention 2: Acetylsalicylic Acid (Aspirin, BAYE4465)
Intervention descriptions: intervention 1: Naproxen sodium 220 mg qd or bid intervention 2: ASA 81 mg qd

Protocol documents:
Clinical trial NCT02234427
Conditions: Atherosclerosis
Keywords: aspirin, atherosclerosis
Sponsor: Johns Hopkins University
Start date: 2014-06-01; Completion date: 2015-05-01
Enrollment: 34 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This clinical trial will examine with effect of 2-week aspirin therapy on platelet gene expression in persons at high-risk of developing heart attacks due to family history of early-onset coronary artery disease

Detailed description:
In this clinical trials we will select individuals from GeneSTAR cohort based o their platelet function. Equal number of individuals will be selected from each race and gender and from low or high platelet aggregation. We will have baseline platelet functions performed and baseline platelet gene expression examined. Participants will be given 2-week supply of aspirin(81 mg/daily) and will be examined at the end of 2-weeks with platelet aggregation studies and a repeat platelet gene-expression (using RNA-seq). The ultimate goal is to examine platelet gene expression differences due to aspirin and across different gender, race, platelet-aggregation groups.

Arms: arm 1: None
Interventions: intervention 1: Aspirin
Intervention descriptions: intervention 1: 2-week aspirin therapy (81mg/day)

Protocol documents:
Clinical trial NCT02242435
Conditions: Osteoarthritis of the Knee
Keywords: Osteoarthritis osteoarthritis of the knee
Sponsor: Ampio Pharmaceuticals. Inc.
Start date: 2014-09-01; Completion date: 2015-05-01
Enrollment: 342 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This study will evaluate the efficacy of three intra-articular injections, given 2 weeks apart, of Ampion™ in Adults with pain due to osteoarthritis of the knee.

Detailed description:
A randomized, placebo-controlled, double-blinded study to evaluate the efficacy and safety of repeated intra-articular injections of Ampion™ in adult subjects with advanced osteoarthritis of the knee.

The primary study objective was to evaluate the efficacy and safety from Baseline to Week 20 of 3 Ampion™ 4 mL intra-articular (IA) injections vs saline administered 2 weeks apart in improving knee pain in subjects suffering from osteoarthritis (OA) of the knee (OAK).

The secondary study objective was to analyze the effect of Ampion 4 mL vs saline on a change in Patient's Global Assessment (PGA) and knee function from Baseline to Week 20.

Arms: arm 1: 4 mL intra-articular injection of Ampion arm 2: 4 mL placebo intra-articular injection
Interventions: intervention 1: 4 mL injection of Ampion intervention 2: 4 mL Injection of Placebo
Intervention descriptions: intervention 1: 4 mL injection of Ampion intervention 2: None

Protocol documents:
Clinical trial NCT02243046
Conditions: Dental Plaque and Gingivitis
Sponsor: Colgate Palmolive
Start date: 2014-12-01; Completion date: 2015-05-01
Enrollment: 162 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This is a six (6) month, double-blind, parallel, controlled clinical trial utilizing one hundred and sixty (160) adults to evaluate the reduction of dental plaque and gingivitis.

Detailed description:

Arms: arm 1: 1450 ppm Fluoride toothpaste arm 2: 1450 ppm sodium fluoride toothpaste with a zinc base arm 3: 1450 ppm sodium fluoride/triclosan toothpaste
Interventions: intervention 1: Control toothpaste intervention 2: Experimental toothpaste intervention 3: Active Comparator
Intervention descriptions: intervention 1: 1450 ppm fluoride toothpaste control - Subjects will brush their whole mouth with the control toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study. intervention 2: 1450 ppm sodium fluoride/zinc base toothpaste - Subjects will brush their whole mouth with a fluoride/zinc toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study. intervention 3: 1450 ppm sodium fluoride/triclosan toothpaste - Subjects will brush their whole mouth with this toothpaste 2 times/day for 1 minute each time and rinse with water after brushing. This daily brushing routine will continue for the six (6) month study.

Protocol documents:
Clinical trial NCT02264353
Conditions: Obstructive Sleep Apnea
Keywords: Obstructive Sleep Apnea Arousal threshold Donepezil
Sponsor: University of California, San Diego
Start date: 2014-09-01; Completion date: 2015-05-01
Enrollment: 44 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
The investigators hypothesis is that obstructive sleep apnea (OSA) patients with a low arousal threshold may wake up too early during a respiratory event, before upper airway muscles can be activated to achieve stable ventilation. Thus, strategies to manipulate the respiratory arousal threshold could potentially improve the quality of sleep and sleep disordered breathing. Agents that raise arousal threshold are therefore likely to benefit some patients with OSA. The overall goal of this project is to determine the importance of the arousal threshold in OSA, determine which patients might benefit from a raised arousal threshold, and test this hypothesis by using pharmacological manipulation of the arousal threshold to achieve this goal.

Detailed description:
This study is a pilot study. The investigators will test whether donepezil has important effects on the arousal threshold and on the apnea hypopnea index.

Donepezil is a cholinesterase inhibitor approved by the U.S. Food and Drug Administration (FDA) for the treatment of symptoms of Alzheimer's disease.

Eligible participants will undergo overnight polysomonography as described below and will receive either donepezil (10 mg immediately prior to sleep) or placebo (in random order) followed roughly 14 days later with placebo or donepezil. This aim will allow us to test the impact of donepezil on the apnea hypopnea index. The study plans to enroll approximately 30 subjects.

The change in apnea hypopnea index as well as arousal thresholds/upper airway mechanics will be compared in the donepezil groups with the placebo group.

Arms: arm 1: Sleep data with Donepezil given arm 2: Sleep data with Placebo given
Interventions: intervention 1: Donepezil intervention 2: placebo
Intervention descriptions: intervention 1: Donepezil 10mg before sleep intervention 2: One piece of placebo before sleep

Protocol documents:
Clinical trial NCT02268396
Conditions: COPD
Sponsor: Pearl Therapeutics, Inc.
Start date: 2014-11-01; Completion date: 2015-05-01
Enrollment: 138 participants; Allocation: NA; Intervention model: SINGLE_GROUP

Brief summary:
This is an open-label, multi-center study to evaluate the accuracy, reliability and functionality of the Glycopyrronium and Formoterol Fumarate (GFF) Metered Dose Inhaler (MDI) dose indicator in adult subjects with moderate to very severe COPD over a 4-week Treatment Period.

Detailed description:

Arms: arm 1: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler (GFF MDI), PT003
Interventions: intervention 1: Glycopyrronium and Formoterol Fumarate Metered-dose Inhaler
Intervention descriptions: intervention 1: GFF MDI administered as 2 inhalations BID

Protocol documents:
Clinical trial NCT02282813
Conditions: Chronic Kidney Disease Hyperparathyroidism, Secondary Vitamin D Deficiency
Keywords: Parathyroid Diseases Renal Insufficiency Kidney Failure, Chronic Hyperparathyroidism, Secondary Vitamin D Hyperparathyroidism Kidney Diseases Kidney Failure Renal Insufficiency, Chronic
Sponsor: OPKO Health, Inc.
Start date: 2013-04-01; Completion date: 2015-05-01
Enrollment: 298 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
This extension study of subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 allows long term evaluation of the safety and efficacy of CTAP101 Capsules in reducing elevated intact parathyroid hormone (iPTH) and correcting vitamin D insufficiency in stage 3 or 4 chronic kidney disease patients.

Detailed description:
Only subjects previously enrolled in studies CTAP101-CL-3001 or CTAP101-CL-3002 are eligible to participate in this extension study. This is a phase 3, open-label study of CTAP101 Capsules, with and without add-on vitamin D hormone therapy.

Arms: arm 1: CTAP101 Capsules 30 or 60 mcg daily for up to 26 weeks arm 2: CTAP101 Capsules 60 mcg +calcitriol daily for 14 weeks arm 3: CTAP101 Capsules 60 mcg +doxercalciferol daily for 14 weeks arm 4: CTAP101 Capsules 60 mcg +paricalcitol daily for 14 weeks
Interventions: intervention 1: CTAP101 Capsules intervention 2: Calcitriol intervention 3: Doxercalciferol intervention 4: Paricalcitol
Intervention descriptions: intervention 1: At week 12, eligible subjects will continue to take 1-2 capsules (30 mcg each capsule) CTAP101 daily intervention 2: At week 12, eligible subjects will be randomized to also take calcitriol 0.25 mcg dose one capsule daily intervention 3: At week 12, eligible subjects will be randomized to also take doxercalciferol 0.5 mcg one capsule daily intervention 4: At week 12, eligible subjects will be randomized to also take paricalcitol 1 mcg one capsule daily

Protocol documents:
Clinical trial NCT02294019
Conditions: Patient Compliance
Keywords: ibuprofen 400 mg actual use compliance
Sponsor: Pfizer
Start date: 2014-11-01; Completion date: 2015-05-01
Enrollment: 738 participants; Allocation: ; Intervention model: 

Brief summary:
This is an open label, multicenter, 30 day study designed to mimic an OTC like environment in which subjects will use the product after making a purchase decision about ibuprofen 400 mg caplets based only on their reading of the Drug Facts Label (DFL) and other information on the package.

Detailed description:

Arms: arm 1: None
Interventions: intervention 1: Ibuprofen 400 mg caplet
Intervention descriptions: intervention 1: 400 milligram (mg) caplet according to Drug Facts label

Protocol documents:
Clinical trial NCT02300311
Conditions: Low Back Pain
Sponsor: Boehringer Ingelheim
Start date: 2015-01-01; Completion date: 2015-05-01
Enrollment: 138 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
To evaluate efficacy of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide) versus placebo in patients with acute low back pain. To investigate the safety and tolerability of repeated use of Finalgon® cream (1.08% Nicoboxil/ 0.17% Nonivamide).

Detailed description:

Arms: arm 1: 2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period arm 2: 2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period
Interventions: intervention 1: nonivamide + nicoboxil (Finalgon cream) intervention 2: placebo matching nonivamide + nicoboxil (Finalgon cream)
Intervention descriptions: intervention 1: 2 cm cream line for a skin area approximately 20 x 20 cm2 up to 3 times in a 24 hour period intervention 2: 2 cm cream line for a skin area of approximately 20 x 20 cm2 up to 3 times in a 24h period

Protocol documents:
Clinical trial NCT02367066
Conditions: Type 2 Diabetes Mellitus
Keywords: patients glycaemic control on metformin
Sponsor: AstraZeneca
Start date: 2015-03-01; Completion date: 2015-05-01
Enrollment: 30 participants; Allocation: RANDOMIZED; Intervention model: CROSSOVER

Brief summary:
A study to assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus

Detailed description:
A Single Centre, Double-blind, Randomised, Placebo-controlled, Cross-over Phase I Study to Assess the Pharmacodynamics of oral AR-C165395XX after Administration of Repeated Doses for 3 days in Subjects with Type 2 Diabetes Mellitus

Arms: arm 1: 1st period AR-C165395XX 2nd period placebo arm 2: 1st period Placebo for AR-C165395XX 2nd period AR-C165395XX
Interventions: intervention 1: AR-C165395XX intervention 2: Placebo
Intervention descriptions: intervention 1: Oral dose of AR-C165395XX (tablets) intervention 2: Oral dose of placebo for AR-C165395XX (tablets)

Protocol documents: