louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02850679: FINnish CardioVersion Study II
Official title: Finnish Elective Cardioversion for Persistent Atrial Fibrillation Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Atrial Fibrillation
Keywords: Atrial Fibrillation
Cardioversion
Lead sponsor: University of Turku
Sponsor class: OTHER
First posted: 2016-08-01
Enrollment: 1342
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 1342 patients with 1998 elective cardioversions

Brief summary: This is a retrospective multi-center patient cohort study investigating patients with persistent atrial fibrillation (AF) and elective cardioversion (ECV). The aim is to identify clinical predictors for ineffective ECV to improve management quality of persistent AF.

Detailed description: Data was gathered from patient registries of two finnish university hospitals and two regional hospitals in a time period of 2003-2015. A data search was conducted using the ICD-10 code for atrial fibrillation and NCSP code for cardioversion. All patients with AF and performed cardioversion were eligible for the study.

Initially, 2373 patients were captured after which all ECV cases were identified and included manually in the study using a structured electronic case report form. The study cohort comprised 1998 ECVs and 1342 patients. Follow-up data was gathered for 30 days after ECV and all strokes, transient ischemic attacks, arrhythmic complications, AF recurrences and failed cardioversions were recorded and subjected to careful exploration. IBM SPSS Statistics software version 22.0 was used to perform all analyses.

Eligibility criteria: Inclusion Criteria:

* All patients with persistent (\>48h) atrial fibrillation and elective electrical cardioversion

Exclusion Criteria:

* Cardioversions for patients with acute (\<48h) atrial fibrillation
* Pharmacological cardioversions

Primary outcomes:
measure: Fatal or Non-fatal Stroke/TIA
timeFrame: 30 days
Secondary outcomes:
measure: Arrhythmic Complications
timeFrame: 24 hours
measure: Failure of Cardioversion
timeFrame: 24 hours
measure: Recurrence of AF after ECV
timeFrame: 30 days
Other outcomes:
Locations:
city: Turku
country: Finland
facility: Turku University Hospital
Study officials:
affiliation: Turku University Hospital
name: Juhani Airaksinen, Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05454579: The South-East Asian Transgender Health Cohort
Official title: The South-East Asian Transgender Health Cohort
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: HIV
STIs
HCV
Keywords: HIV
Lead sponsor: Institute of HIV Research and Innovation Foundation, Thailand
Sponsor class: OTHER
Collaborators: name: amfAR, The Foundation for AIDS Research
First posted: 2022-07-12
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: * transgender woman or
* transgender man

Brief summary: This is a prospective observational cohort study that will enroll 300 HIV-negative transgender people and 150 transgender people living with HIV from 4 community health centers in Thailand, Vietnam, and the Philippines. Each participant will be followed-up until the completion of 24 months.

Detailed description: This prospective observational cohort study will longitudinally track physical (e.g. HIV/STI, sexual risk behavior, gender affirmation, clinical information, cardiovascular health, medical history) and mental health (e.g. stigma and discrimination, gender-based violence, anxiety, depression); identify biomedical, structural, and psychosocial factors impacting physical and mental health among transgender people; describe the structural barriers to healthcare experienced by transgender people as well as develop the guidance on holistic healthcare policies for transgender people.

Eligibility criteria: Inclusion Criteria:

* Thai/Vietnamese/Filipino nationality
* Aged ≥ 18 years old
* Self-identify as a transgender woman or transgender man
* Have signed consent form

Exclusion Criteria:

* None

Primary outcomes:
measure: New cases of HIV infection in transgender people
timeFrame: 24 months
measure: Mental health status in transgender people
timeFrame: 24 months
measure: Structural factors and psychosocial factors that impact the physiology and mental health of transgender people
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Pasay
country: Philippines
facility: Victoria by LoveYourself
state: Manila
city: Bangkok
country: Thailand
facility: Rainbow Sky Association of Thailand (RSAT)
state: Bangkapi
city: Pathum wan
country: Thailand
facility: Institute of HIV Research and Innovation
state: Bangkok
city: Pathum wan
country: Thailand
facility: Tangerine Clinic, Institute of HIV Research and Innovation
state: Bangkok
city: Ho Chi Minh
country: Vietnam
facility: Glink Clinics, Ho Chi Minh City (HCMC), Vietnam Glink Clinic HCMC1
state: Thuong Kiet Street
Study officials:
References:
Clinical trial NCT00596479: Filgrastim for the Promotion of Collateral Growth in Patients With CAD
Official title: Subcutaneous Delivery of Filgrastim (rG-CSF) for the Promotion of Collateral Growth in Patients With Coronary Artery Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Coronary Artery Disease
Keywords: CAD
G-CSF
Collaterals
CFI
perfusion
Lead sponsor: Insel Gruppe AG, University Hospital Bern
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
name: Swiss Heart Foundation
First posted: 2008-01-17
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.

Detailed description: The purpose of this study in humans with stable coronary artery disease (CAD) treatable by PCI (percutaneous coronary intervention) is to evaluate the safety and efficacy of subcutaneous delivery of recombinant granulocyte colony stimulating factor rG-CSF (Filgrastim, Neupogen®, Amgen Switzerland) with regard to the promotion of collateral growth.

Eligibility criteria: Inclusion Criteria:

* Age \> 18 years old
* 1- to 3-vessel coronary artery disease (CAD)
* Stable angina pectoris
* At least 1 stenotic lesion suitable for PCI
* No Q-wave myocardial infarction in the area undergoing CFI measurement
* Written informed consent to participate in the study

Exclusion Criteria:

* Patients admitted as emergencies
* Acute myocardial infarction
* Unstable CAD
* CAD treated best by CABG
* Patients with overt neoplastic disease
* Patients with diabetic retinopathy
* Liver or kidney disease
* Pre-menopausal women

Primary outcomes:
measure: Collateral flow index (CFI) at 2 weeks follow-up compared to baseline CFI
Secondary outcomes:
measure: Absolute myocardial perfusion during hyperemia by contrast echocardiography (MCE) at baseline, at 2 weeks and at 6 month follow-up
Other outcomes:
Locations:
city: Bern
country: Switzerland
facility: University Hospital Bern
Study officials:
affiliation: University of Bern
name: Steffen Gloekler, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Tobias Rutz, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Pascal Meier, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Bern
name: Christian Seiler, MD
role: STUDY_CHAIR
References:
citation: Meier P, Gloekler S, de Marchi SF, Indermuehle A, Rutz T, Traupe T, Steck H, Vogel R, Seiler C. Myocardial salvage through coronary collateral growth by granulocyte colony-stimulating factor in chronic coronary artery disease: a controlled randomized trial. Circulation. 2009 Oct 6;120(14):1355-63. doi: 10.1161/CIRCULATIONAHA.109.866269. Epub 2009 Sep 21.
Clinical trial NCT02924779: An Observational Study Investigating the Positioning of Epidural Catheters and Their Function During Labour Analgesia
Official title: An Observational Study Investigating the Influence of Physical Position of Epidural Catheters and Their Function During Labour Analgesia
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Labour Analgesia, Epidural Anaesthesia
Lead sponsor: Rotkreuzklinikum München gGmbH
Sponsor class: OTHER
First posted: 2016-10-05
Enrollment: 40
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All women who request epidural analgesia during birth are eligible

Brief summary: This is a small observational study investigating the physical changes that occur to epidural catheters after insertion for obstetric anaesthesia. Using the observed physical changes as a correlate for the position of the catheter in the patient we will investigate a connection between the position and e function during labour. This information may be useful in guiding the physicians responses to epidurals that do not provide adequate analgesia to aid in deciding on the most appropriate action


Eligibility criteria: Inclusion Criteria:

* any women in labour requesting epidural anaesthesia

Exclusion Criteria:

* none

Primary outcomes:
measure: Position of epidural catheter
timeFrame: directly after removal of the epidural
measure: Analgesia effectiveness
timeFrame: directly after removal of the epidural
Secondary outcomes:
measure: secondary caesarean section
timeFrame: directly after removal of the epidural
measure: Impact on motor function
timeFrame: directly after removal of the epidural
Other outcomes:
Locations:
city: München
country: Germany
facility: Frauenklinik Taxisstrasse
state: Bayern
Study officials:
affiliation: Anaesthetist Rotkreuzklinikum München
name: Ellis Muggleton, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00844779: Molecular Investigation of Non Alcoholic Fatty Liver Diseases in Obese Patients
Official title: Evaluation of Non Alcoholic Metabolic Liver Diseases in Patients Harboring Central Adiposity and Insulin Resistance by Biochemical and Functional Genomic Approaches
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Liver Disease
Keywords: Metabolic syndrome- hepatic steatosis- steatohepatitis - gene expression
Non alcoholic fatty liver disease (NFALD)
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2009-02-16
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Primary care clinic

Brief summary: Non alcoholic fatty liver diseases (NAFLD) are represented by two main pathological conditions, hepatic steatosis (HS) and non alcoholic steatohepatitis (NASH), which are characterized by the accumulation of fat in the liver. The diagnosis of these two entities is achieved by histology and neither imaging nor biochemical markers are accurate enough to discriminate them. At the contrary of HS, NASH features hepatocyte necrosis, inflammation and fibrosis of variable intensity that could progress and ultimately evolve to cirrhosis. Therefore, it is important to distinguish between HS and NASH in order to treat the patients accordingly. In this study, the investigators aim to understand the molecular mechanisms that govern the transition from benign steatosis to complicated NASH. The investigators will analyze by "Q-RT-PCR" and "DNA microarray" technologies in the liver of obese patients, the expression of genes that are susceptible to be involved in the pathogenesis of NAFLD and identify the potential signaling pathways responsible for the progression of the disease.


Eligibility criteria: Inclusion Criteria:

* Group T(n=30): patient without central adiposity, without insulin resistance, operated for cholecystectomy or a benign liver tumor
* Group A (n=30): patient with central adiposity, insulin resistance and hepatic steatosis (histology).
* Group B (n=30): patient with central adiposity, insulin resistance and steatohepatitis ± hepatic fibrosis (histology).

Exclusion Criteria:

* viral or autoimmune hepatitis
* hematochromatosis
* alcohol consumption (\> 20 g/24h women, \>30 g/24h men)
* type 1 diabetes
* inflammation or infection before procedure
* abnormal hemostasis or coagulation- pregnancy

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Hépato-Gastro-Entérologie - Nouvel Hôpital Civil
city: Strasbourg
country: France
facility: Service de Chirurgie Digestive et Endocrinienne - Nouvel Hôpital Civil
Study officials:
affiliation: Hôpitaux Universitaires de Strasbourg
name: Michel DOFFOEL, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02290379: Phase 1 Single Ascending Dose Safety Study of TNX-201 Capsules in Healthy Volunteers
Official title: A Single-Center, Randomized, Double-blind, Placebo-controlled, Phase 1, Single Ascending Dose Safety, Tolerability, and Pharmacokinetic Study of TNX-201 Capsules in Healthy Volunteers.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy
Lead sponsor: Tonix Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
First posted: 2014-11-14
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers.

Detailed description: Single-center, randomized, double-blind, placebo-controlled, single ascending dose, safety and tolerability study of TNX-201 capsules in healthy volunteers. Three successive cohorts are planned with doses of TNX-201 capsules, 35 mg, 70 mg, and 140 mg, respectively. Each cohort will consist of 15 subjects, and subjects will be randomly assigned to TNX-201, racemic isometheptene, or placebo capsules.

Eligibility criteria: Inclusion Criteria:

1. Male or female, ≥ 18 and ≤ 55 years of age on the day of randomization. NOTE: At least 6 female subjects need to be randomized in each cohort.
2. Body mass index (BMI) ≥18.5 and ≤33.0
3. Non-tobacco users (no use of tobacco- or nicotine- containing products within 3 months prior to study drug administration)

Exclusion Criteria:

1. Any clinically significant abnormality or clinically significant abnormal laboratory test results found at Screening or Day -1, or a positive test for HBsAg, HCAb, or HIV found at Screening
2. Positive urine drug screen (including alcohol, tetrahydrocannabinol (THC), cocaine, amphetamines, and opiates) or urine cotinine test at Screening or on Day -1
3. Known or suspected hypersensitivity to isometheptene mucate or any excipients used in the formulations.
4. Positive serum pregnancy test at Screening or Day -1
5. Any reason, in the opinion of the Principal Investigator (PI) or the sponsor's Medical Monitor, to prevent the subject from participating in the study
6. Clinically significant ECG abnormalities

Primary outcomes:
measure: Plasma levels of isometheptene or metabolites.
timeFrame: 60 minutes pre-dose and multiple timepoints up to 48 hours post-dose
measure: Number of Adverse events
timeFrame: 60 minutes pre-dose and multiple timepoints up to 48 hours post-dose
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT05085379: Optical Coherence Tomography of the Middle Ear Using Ossiview
Official title: Optical Coherence Tomography of the Middle Ear Using Ossiview
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Middle Ear Disease
Lead sponsor: University of Arkansas
Sponsor class: OTHER
First posted: 2021-10-20
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Target pathologies in the subject population are subjects with:

* Chronic ear disease
* Suspected mixed hearing loss or sensorineural hearing loss
* Otosclerosis
* Suspected or confirmed conductive hearing loss
* Cholesteatoma
* Otitis Media
* Ossicular erosion
* Perforated TM
* Ossicular fixation
* Functioning middle ear prosthesis
* Failed middle ear prosthesis
* Head/Ear trauma patients
* Cochlear implant patients
* Previous tympanoplasty
* Vascular defects
* Tympanosclerosis

Brief summary: The aim of this study is to understand the diagnostic applications for this imaging technology and identify particular disorders to target for future clinical investigations. Images obtained with the Ossiview device will be correlated to other standard of care (SoC) testing including microscopic otoscopy, CT scans, MRIs, audiologic testing results, and surgical and pathology reports.

Detailed description: Optical Coherence Tomography (OCT) is an optical imaging technique that uses a low-coherence interferometer to produce depth-resolved scans in tissue. This study will explore the utility of this technology in otology patients presenting with various pathologies as well as normal subjects.

Eligibility criteria: Inclusion Criteria

* Age ≥18 years
* Ability to understand the consent process with adequate language and cognitive communication ability
* Presence of one of the pathologies (either currently or in the past) above or healthy control

Exclusion Criteria

* Narrow or stenotic external meatus (ear canal)
* Movement disorder causing inability to keep head still during imaging

Primary outcomes:
measure: Diagnostic correlation with microscopic otoscopy
timeFrame: 6 months
measure: Diagnostic correlation with CT scans
timeFrame: 6 months
measure: Diagnostic correlation with Magnetic Resonance Imaging (MRI)s
timeFrame: 6 months
measure: Diagnostic correlation with audiologic testing results
timeFrame: 6 months
measure: Diagnostic correlation with surgical reports
timeFrame: 6 months
measure: Diagnostic correlation with pathology reports
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: Little Rock, AR
country: United States
facility: University of Arkansas for Medical Sciences
state: Arkansas
Study officials:
affiliation: University of Arkansas
name: Deanne King, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01243879: The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects
Official title: The Effect of Food Stimuli on the Calorie Restriction Response in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Calorie Restriction
Aging
Keywords: fasting
starvation
calorie restriction
fMRI
Lead sponsor: Leiden University Medical Center
Sponsor class: OTHER
Collaborators: name: Center for Medical Systems Biology
name: Roba Metals BV, IJsselstein
First posted: 2010-11-19
Enrollment: 12
Sex: MALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: OTHER

Brief summary: Calorie restriction extends life span and prevents aging-related diseases in several species. Odorants from live yeast restrain the beneficial effects of calorie restriction in Drosophila Melanogaster. The investigators hypothesize that visual and odorous food stimuli impact the neuroendocrine and metabolic response to starvation in healthy humans.

In this randomized cross-over intervention study 12 healthy, young men will fast twice for 60-hours in the presence or absence of food-related visual and odorous stimuli. At baseline and on the last morning of each intervention an oral glucose tolerance test (OGTT) will be performed. During the OGTT blood is sampled and hypothalamic neuronal activity is measured by functional MRI.


Eligibility criteria: Inclusion Criteria:

* Caucasian male volunteers
* Age \> 18 years and \< 70 years
* Body mass index (BMI) \> 20 kg/m2 and \< 25 kg/m2
* Fasting serum glucose (FSG) \< 6.1 mmol/L

Exclusion Criteria:

* Any significant chronic of hereditary disease (including renal, hepatic or endocrine disease)
* Any significant abnormal laboratory results found during the medical screening procedure
* Any use of medication (except for NSAID)
* Anosmia or any other (acquired) loss of olfaction (ea. rhinitis)
* Recent weight changes or attempts to loose weight (\> 3 kg weight gain or loss, within the last 3 months)
* Difficulties to insert an intravenous catheter
* Smoking
* MRI contraindications
* Recent blood donation (within the last 3 months)
* Recent participation in other research projects (within the last 3 months), participation in 2 or more projects in one year

Primary outcomes:
measure: Endocrine and metabolic outcomes
timeFrame: 4 weeks
Secondary outcomes:
measure: functional Magnetic Resonance Imaging
timeFrame: 4 weeks
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00173979: Tendon Mechanical Properties and Morphological Characteristics of Human Bicep and Tricep Muscles: An In Vivo Ultrasonographical Study
Official title: Tendon Mechanical Properties and Morphological Characteristics of Human Muscle
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Healthy
Keywords: muscle
tendon
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2005-09-15
Enrollment: 15
Sex: MALE
Minimum age (years): 19
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This current study tests whether the load-displacement and stress-strain characteristics of human bicep and tricep muscles and tendons change during graded maximal voluntary elbow extension and flexion exercises.


Eligibility criteria: Inclusion Criteria:

* Healthy male subjects
* Age range from 18-35 years

Exclusion Criteria:

* History of shoulder/elbow which needs medical treatment or surgery

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: School and Graduate Institute of Physical Therapy, NTU, Taiwan
Study officials:
affiliation: School and Graduate Institute of Physical Therapy, NTU
name: Hsing-Kuo Wang, PhD
role: STUDY_DIRECTOR
References: