louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01953029: Mechanisms of Myocardial Infarction in Women With Non Obstructive Coronary Artery Disease
Official title: Mechanisms of Myocardial Infarction in Women With Non Obstructive Coronary Artery Disease
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Myocardial Infarction
Lead sponsor: Rambam Health Care Campus
Sponsor class: OTHER
First posted: 2013-09-30
Enrollment: 80
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women with myocardial infarction

Brief summary: The objective of our work to determine the mechanisms of myocardial infarction in women without obstructive coronary artery disease.

Detailed description: Cardiovascular disease is the leading cause of death for women. Acute coronary syndrome (ACS) is usually characterized by a sudden erosion of the endothelial wall or rupture of a plaque.However, women with ACS are less likely than men to have either classic symptoms or obstructive coronary artery disease but paradoxically have a worse prognosis. Different data from the literature indicate that there may be different pathophysiological mechanisms, afflicting men and women somewhat differently.Between 5% and 30% of patients with ACS undergoing coronary angiography are found to have non visible or non obstructive coronary disease (NOCD). This is 2-3 times more common in women than in men. Several pathogenetic mechanism of myocardial infarction (MI) in the absence of obstructive coronary artery disease (OCD) have been postulated, including among others atherosclerosis with plaque disruption that does not lead to luminal occlusion ,endothelial dysfunction, vasospasm , distal microembolization and microvascular dysfunction. However the data are extremely limited.

Eligibility criteria: Inclusion Criteria:

* Women ≥ 18 years old, not pregnant
* with acute non ST elevation myocardial infarction (admitted within 12 hours from beginning of symptoms)
* who are candidates for coronary arteriography during the hospitalization. -

Exclusion Criteria:

\*Women with troponin elevation caused by other causes -

Primary outcomes:
measure: MORTALITY
timeFrame: 1 YEAR
Secondary outcomes:
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Heath Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Miry Blich, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00248729: Effectiveness and Safety Study of Etomidate Versus Midazolam to Help Place a Breathing Tube Outside of the Hospital.
Official title: Etomidate Versus Midazolam for Pre-Hospital Intubation: A Prospective, Randomized Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Respiratory Failure
Lead sponsor: St. Luke's Hospital, Pennsylvania
Sponsor class: OTHER
First posted: 2005-11-04
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The objective of this study was to compare the utility of etomidate and midazolam in helping patients to relax when there was a need for the placement of a ventilation tube by medics who were transporting patients to a hospital in an ambulance.

Detailed description: Study Objective: The objective of this study was to compare the utility of etomidate and midazolam for sedative facilitated intubation (SFI), without paralytics, in pre-hospital adult patients.

Methods: This prospective, double-blind, randomized trial was conducted with two ground pre-hospital Advanced Life Support (ALS) units. All patients age 18 or over transported by the two participating systems requiring pre-hospital SFI were eligible for participation. The ambulances were stocked with blinded numbered syringes, each containing either 7mg of midazolam or 20mg of etomidate. Contact with the Medic Command physician was not required and no paralytics were used. If sedation was not achieved with the study drug, medics could request additional sedation from a Medical command physician; only midazolam or diazepam were available outside of the study.

Eligibility criteria: Inclusion Criteria:

Under the study protocol, all patients age 18 or over transported by the two participating ALS systems, requiring pre-hospital Sedation Facilitated Intubation, were eligible for participation.

Exclusion Criteria:

Exclusion criteria were pregnancy and age less than 18.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Bethlehem
country: United States
facility: St. Luke's Hospital
state: Pennsylvania
Study officials:
affiliation: St. Luke's Hospital
name: Jeanne L Jacoby, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT04456829: Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin Conditions and Inflammatory Related Factors
Official title: Investigation of the Efficacies of a Resveratrol Formula on Improvement of Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Conditions
Proinflammatory Cytokines
Lead sponsor: TCI Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2020-07-07
Enrollment: 60
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To assess a resveratrol formula on improvement of skin conditions and inflammatory cytokines in blood


Eligibility criteria: Inclusion Criteria:

* Healthy volunteers aged above 20 years old

Exclusion Criteria:

* Subject who is not willing to participate in this study.
* Patients with diseases of the skin, heart, liver, kidney, endocrine and other organs and patients with mental illness (according to medical history).
* Subjects who have known cosmetic, drug or food allergies, difficulty in digestive tract absorption or disorder.
* Female who is pregnant or nursing or planning to become pregnant during the course of the study.
* Received facial laser therapy, chemical peeling or UV overexposure in the past 4 weeks.
* Subjects who have large spots (area \>3 square centimeter) or abnormal acne.

Primary outcomes:
measure: The change of skin moisture
timeFrame: 0, 4, and 8 weeks
measure: The change of skin elasticity
timeFrame: 0, 4, and 8 weeks
measure: The change of skin wrinkles
timeFrame: 0, 4, and 8 weeks
measure: The change of skin collagen density
timeFrame: 0, 4, and 8 weeks
measure: The change of skin texture
timeFrame: 0, 4, and 8 weeks
measure: The change of skin pores
timeFrame: 0, 4, and 8 weeks
measure: The change of total antioxidant capacity of blood
timeFrame: 0 and 8 weeks
measure: The change of TNF-alpha of blood
timeFrame: 0 and 8 weeks
measure: The change of IL-6 of blood
timeFrame: 0 and 8 weeks
measure: The change of IL-17 of blood
timeFrame: 0 and 8 weeks
measure: The change of IL-1β of blood
timeFrame: 0 and 8 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Tainan City
country: Taiwan
facility: Chia Nan University of Pharmacy & Science
Study officials:
References:
Clinical trial NCT01550029: Targeted Intervention for Bipolar Smokers
Official title: Targeted Intervention for Bipolar Smokers
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Nicotine Dependence
Bipolar Disorder
Keywords: Smoking
Tobacco
Nicotine
Bipolar
Lead sponsor: University of Cincinnati
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2012-03-09
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this research is to develop and test a new type of smoking cessation counseling for individuals with bipolar disorder.

Detailed description: All participants will receive the nicotine patch, an FDA-approved smoking cessation medication, in an open-label fashion. In addition to the nicotine patch, participants will be randomized to receive one of the two types of counseling for smoking cessation. Participants will be in the research study for approximately 18 weeks. The total number of study visits is 15.

Eligibility criteria: Inclusion Criteria:

* Participants who are motivated to quit smoking
* Male or female
* 18 years of age or older
* Diagnosed with bipolar disorder according to DSM-IV criteria
* Stable on medication with no significant changes in the last 3 months before enrollment.
* Smoking 10 cigarettes/day for the past 90 days

Exclusion Criteria:

* Healthy volunteers
* Patients not meeting the criteria for the diagnosis of Bipolar Disorder according to DSM-IV criteria
* Not being and being treated with medication for the bipolar disorder

Primary outcomes:
measure: Prolonged Abstinence from Smoking
timeFrame: Last four weeks of treatment period
Secondary outcomes:
measure: Prevalence of Abstinence from Smoking
timeFrame: Last 7 days of treatment period
Other outcomes:
Locations:
city: Cincinnati
country: United States
facility: The University of Cincinnati
state: Ohio
Study officials:
affiliation: University of Cincinnati
name: Jaimee Heffner, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06417229: Study to Evaluate Safety, Drug Levels, Food and Relative Bioavailability of BMS-986365 in Healthy Adult Male Participants
Official title: A Phase 1, Two-part, Open-label Single Ascending Dose Study to Evaluate Safety, Tolerability, and Pharmacokinetics of BMS-986365, Food and Proton Pump Inhibitor Effects, and Relative Bioavailability of BMS-986365 Capsule Compared to Tablet Formulation in Healthy Adult Male Participants
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Participants
Keywords: BMS-986365
Pharmacokinetics
Relative Bioavailability
Healthy Male Volunteers
CC-94676
Food Effect
Proton Pump Inhibitor
Lead sponsor: Celgene
Sponsor class: INDUSTRY
First posted: 2024-05-16
Enrollment: 102
Sex: MALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, tolerability, drug levels, food effects and relative bioavailability of BMS-986365 in healthy male participants.


Eligibility criteria: Inclusion Criteria:

* Healthy adult male participants as determined by no clinically significant deviations from normal in medical history, physical examination, vital signs, ECGs, echocardiogram, or clinical laboratory assessments as determined by the investigator.
* Body mass index (BMI) of 18.0 to 32.0 kg/m\^2, inclusive.

Exclusion Criteria:

* Any significant acute or chronic illness.
* Prior history of heart failure, ischemic heart diseases, serious cardiac arrythmias, or prolonged QT interval.
* History of allergy/hypersensitivity to any component (including excipients) of BMS-986365 study interventions or related compounds.
* Other protocol-defined inclusion/exclusion criteria apply.

Primary outcomes:
measure: Maximum observed plasma concentration (Cmax)
timeFrame: Up to Day 75
measure: Area under the plasma concentration-time curve from time zero to time of the last quantifiable concentration [AUC(0-T)]
timeFrame: Up to Day 75
measure: Area under the plasma concentration-time curve from time zero extrapolated to infinite time [AUC(INF)]
timeFrame: Up to Day 75
Secondary outcomes:
measure: To assess the bioavailability of BMS-986365 experimental formulation relative to the reference formulation
timeFrame: Up to Day 75
measure: Incidence of adverse events (AE)
timeFrame: Up to Day 75
measure: Incidence of serious adverse events (SAE)
timeFrame: Up to Day 75
measure: Number of participants with physical examination abnormalities
timeFrame: Up to Day 75
measure: Number of participants with vital sign abnormalities
timeFrame: Up to Day 75
measure: Number of participants with clinical laboratory abnormalities
timeFrame: Up to Day 75
measure: Number of participants with electrocardiogram (ECG) abnormalities
timeFrame: Up to Day 75
Other outcomes:
Locations:
city: Lenexa
country: United States
facility: Local Institution - 0001
state: Kansas
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT04957329: Effect of Benzalkonium Chloride Preserved and Preservative-free Latanoprost Eye Drops on Conjunctival Goblet Cells
Official title: Department of Ophthalmology, Rigshospitalet-Glostrup Valdemar Hansens Vej 13, 2600 Glostrup, Denmark
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE4
Conditions: Glaucoma
Ocular Hypertension
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: Laboratoires Thea
First posted: 2021-07-12
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: each subject will be treated with a BAK-preserved eye drop in one eye and PF-eye drops in the other eye for 3 months.
Primary purpose: TREATMENT

Brief summary: a randomized, investigator-blind, interventinal study will compare the effect of benzalkonium-chloride (BAK) preserved and preservative-free (PF) eye drops on conjunctival goblet cells.

Detailed description: The investigators will conduct a randomized, investigator-blind, interventinal study on 28 subjects. Each subject will apply a benzalkonium-chloride (BAK) preserved eye drop (Xalatan) in one eye and a preservative-free (PF) eye drop (Monoprost) in the other for 3 months. Which eye gets which treatment is randomized. Before and after treatment a conjunctival print will be made and the effect of the eye drops on goblet cell density will be evaluated along with effect on the intraocular pressure.

Eligibility criteria: Inclusion Criteria:

1. Age \>18years
2. Danish speaking
3. Open angle glaucoma or ocular hypertension
4. Average intraocular pressure equal to or above 22 mmHg

Exclusion Criteria:

a. history of significant eye diseae (including okular trauma) other than open angle glaucoma and ocular hypertension d. treatment with steroids within the last 3 months from inclusion e. Significant untreated systemic disease such as hypertension, heart failure, diabetes mellitus, stroke, lung disease and autoimmune diseases. Diseases are not reason for exclusion if they are well treated or does not need treatment g. pregnant or breast feeding h. women using unsafe anticonception i. allergy towards trial medication j. patients who cannot cooperate in eye examination k. ocular surface defects l. need for polytherapy in glaucoma treatment

Primary outcomes:
measure: Goblet cell density
timeFrame: 3 months
Secondary outcomes:
measure: Intraocular pressure
timeFrame: 3 months
measure: Ocular surface
timeFrame: 3 months
measure: Mucin content in tear film
timeFrame: 3 months
measure: Cytokines in tear film
timeFrame: 3 months
measure: Ocular surface disease index evaluation
timeFrame: 3 months
Other outcomes:
Locations:
city: Glostrup
country: Denmark
facility: Department of ophthalmology, rigshospitalet.glostrup
state: Danmark
city: Copenhagen
country: Denmark
facility: Department of drug design and pharmacology, University of Copenhagen
Study officials:
affiliation: Department of ophthalmology, rigshospitalet-Glostrup
name: Miriam Kolko, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01624129: New Serological Markers for Eosinophilic Esophagitis
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Eosinophilic Esophagitis
Lead sponsor: Technical University of Munich
Sponsor class: OTHER
First posted: 2012-06-20
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: primary care clinic

Brief summary: The purpose of the study is to investigate if serological parameters such as "extracellular Serum-Tryptase (ST)" and "eosinophilic cationic protein (ECP)" are useful for the diagnosis and surveillance of the eosinophilic esophagitis (EE).

Detailed description: The eosinophilic esophagitis (EE) is chronic inflammatory and immunological disease. The diagnosis of EE is based upon large numbers of eosinophils in the esophagus on histopathologic examination (\> 20 eosinophils per high powered field in at least one specimen) despite acid suppression with a Proton-Pump-Inhibitor (PPI) for at least two weeks.

There are no diagnostic serological markers for EE so far, so that the purpose of the study is to investigate serological markers which are established in other allergic diseases.

Eligibility criteria: Inclusion Criteria:

* histopathological defined eosinophilic esophagitis
* Age: 18-80

Exclusion Criteria:

* missing consent form
* contraindications for performing esophagogastroscopy/taking biopsies of the esophagus

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Munich
country: Germany
facility: II. Medical Department, Technical University Munich
state: Bavaria
Study officials:
affiliation: Technical University of Munich, 2nd Medical Department
name: Monther Bajbouj, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Schlag C, Pfefferkorn S, Brockow K, Haller B, Slotta-Huspenia J, Schulz S, von Werder A, Ring J, Schmid RM, Bajbouj M. Serum eosinophil cationic protein is superior to mast cell tryptase as marker for response to topical corticosteroid therapy in eosinophilic esophagitis. J Clin Gastroenterol. 2014 Aug;48(7):600-6. doi: 10.1097/01.mcg.0000436439.67768.8d.
Clinical trial NCT00692029: Kinematics of Youth (Age 12-15) on Stationary All Terrain Vehicles
Official title: Kinematics of Youth (Age 12-15) on Stationary All Terrain Vehicles
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: Normal
Healthy Volunteers
Lead sponsor: University of Kentucky
Sponsor class: OTHER
First posted: 2008-06-06
Enrollment: 40
Sex: MALE
Minimum age (years): 12
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: PreTeen and Teenage children

Brief summary: To assess the relationship between pre-teen/teen height, age, weight, gender, and body proportions and shape and size of youth and comfort and safety when operating adult All Terrain Vehicles (ATV).


Eligibility criteria: Inclusion Criteria:

1. males
2. age 12-15
3. a minimum level of physical skill to mount and dismount the vehicle
4. ability to speak and understand English.

We have used this age group because it is the most often injured group and represents an entire age group for ATV size restriction (other age groups not studied here are 6-11, and 16 or greater).

Exclusion Criteria:

1. inability to participate in physical education without restrictions
2. visual acuity \< 20/40 corrected
3. females
4. emancipated minors.

We have excluded females to gain the most consistent body dimensions in this preliminary study.

Primary outcomes:
measure: Quantify relationship of youth size/shape to comfort and safety when operating adult ATV
timeFrame: 1 session
Secondary outcomes:
Other outcomes:
Locations:
city: Lexington
country: United States
facility: University of Kentucky
state: Kentucky
Study officials:
affiliation: University of Kentucky
name: Andrew C. Bernard, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06808529: Effect of Pilates Exercises and TENS Acupuncture in Primary Dysmenorrhea Among Female Students At KAU
Official title: A Study on the Effectiveness of Pilates and TENS Acupuncture in Treating Primary Dysmenorrhea in Female Students At King Aboulaziz University (KAU)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Dysmenorrhea Primary
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-02-05
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 24
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study was done to determine the effect of Pilates exercises and TENS acupuncture in primary dysmenorrhea among female students at King Abdulaziz University (KAU).


Eligibility criteria: Inclusion Criteria:

* Participants suffering from primary dysmenorrhea.
* Their age ranged between 18-24 years
* Their BMI less than 30 kg/m2.

Exclusion Criteria:

* Gynecological disorders (secondary dysmenorrhea)
* Married females,
* Low back pain due to any other pathology
* Chronic diseases (diabetes, high blood pressure)

Primary outcomes:
measure: Visual Analogue scale
timeFrame: 2 months
Secondary outcomes:
measure: Verbal multidimensional scoring system of dysmenorrhea
timeFrame: 2 months
Other outcomes:
Locations:
city: Jeddah
country: Saudi Arabia
facility: king Abdulaziz university
Study officials:
References:
Clinical trial NCT01755429: To Characterize the Safety and Tolerability of Eculizumab in Two Japanese aHUS Patients
Official title: A Research Study to Describe the Safety and Efficacy of Eculizumab in Japanese Patients With Atypical Hemolytic Uremic Syndrome (aHUS). An Assessment of Two Case Studies
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: ATYPICAL HEMOLYTIC UREMIC SYNDROME (AHUS)
Lead sponsor: Alexion Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2012-12-24
Enrollment: 2
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The two identified Japanese patients with aHUS for which eculizumab treatment was initiated in 2011

Brief summary: This protocol is intended to formally collect data on the treatment of aHUS with eculizumab in Japanese patients.


Eligibility criteria: Inclusion Criteria:

1. Patient and/or legal guardian must be willing and able to give written informed consent and id the patient is not an adult and able to read and write, the patient is willing to give written informed assent
2. Eculizumab treatment initiated as personal importation for aHUS in 201

Exclusion Criteria:

Not Applicable

Primary outcomes:
measure: Change in platelet count from baseline
timeFrame: 26 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Matsumoto
country: Japan
facility: Shinshu University School of Medicine
city: Tokyo
country: Japan
facility: Tokyo Medical and Dental University
Study officials:
References: