louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT02409953: Effect of Immersion, Performed Under the Conditions of Obstetrical Dilatation Bath, on Diuresis and Hemodynamic Variables in Young Women
Official title: Effect of Immersion, Performed Under the Conditions of Obstetrical Dilatation Bath, on Diuresis and Hemodynamic Variables in Young Women
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: volunteers
Lead sponsor: University Hospital, Strasbourg, France
Sponsor class: OTHER
First posted: 2015-04-07
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Like in the full immersion, studied in the context of diving, immersion in water causes a cascade of events with hemodynamic and hormonal consequences.

First, immersion leads to a relative hypervolemia by venous redistribution and then 40-60 minutes later, hypovolemia by stimulating diuresis.

Dilatation bath is helpful in relieving moderate pain the first stage of obstetrical labor.

However, when the labor progresses, the dilatation bath is no longer sufficient and epidural analgesia remains the only effective method to control pain.

Used before the realization of an epidural analgesia, dilatation bath could affect blood volume and thus worsen the hemodynamic consequences of the sympathetic block that is linked to the installation of sensory block of the epidural analgesia in the parturient (severe prolonged maternal hypotension that can cause a decrease of the placental perfusion and fetal distress).

Before beginning a study in pregnant women, it seems essential to study the hemodynamic consequences of the dilatation bath in a comparable population of volunteers healthy young women and out of the obstetrical context.


Eligibility criteria: Inclusion Criteria:

Healthy female volunteers aged 18 to 45 years

Exclusion Criteria:

* pregnancy
* menopause (confirmed for at least 12 weeks)
* breastfeeding
* Proteinuria\> 2 cross on the dipstick
* Glycosuria \> 2 cross on the dipstick
* subject with no empty stomach for at least 8 hours
* Taking medication in the week before the test affecting diuresis, production of antidiuretic hormone or on the cardiovascular system: paracetamol, nonsteroidal anti-inflammatory Alcohol intake the day before the tes

Primary outcomes:
measure: diuresis (urine volume in milliliters)
timeFrame: 120 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Strasbourg
country: France
facility: Service d'Anesthésie - Réanimation Chirurgicale de Hautepierre
state: Alsace
Study officials:
References:
Clinical trial NCT06996353: Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser
Official title: Clinical Data Collection of Myopic Patients After PTK-PRK With CZM MEL 90 Excimer Laser for Verification of Predicted Refractive Outcome Using EpiMaster Software Considering Epithelial Remodelling
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Refractive Errors
Lead sponsor: London Vision Clinic
Sponsor class: OTHER
Collaborators: name: Optana GmbH
First posted: 2025-05-30
Enrollment: 150
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patient present with myopic or myopic and astigmatic error

Brief summary: The objective of the clinical investigation presented to is to verify predictions of post-operative PTK-PRK refractive outcome made by the EpiMaster application software by comparing these to post-operative clinical data after routine PTK-PRK treatments.

Detailed description: The objective of the clinical investigation presented to is to verify predictions of post-operative PTK-PRK refractive outcome made by the EpiMaster application software by comparing these to post-operative clinical data after routine PTK-PRK treatments.

The EpiMaster application software is not used in this clinical investigation, consequently, it is a merely observational investigation.

Eligibility criteria: Inclusion Criteria:

* Inclusion criteria are according to the user manual of CZM MEL 90 Excimer Laser for treatment of refractive errors
* Patient present with myopic or myopic and astigmatic error
* Patient will be able to understand the patient information and willing to sign an informed consent
* Patient will be willing to comply with all follow-up visits and the respective examinations

Exclusion Criteria:

* Exclusion criteria are according to the user manual of CZM MEL 90 Excimer Laser for treatment of refractive errors

Primary outcomes:
measure: Difference of SE(measured) and SE(predicted by EpiMaster)
timeFrame: 6 months
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: London Vision Clinic Ltd., London, United Kingdom
name: Dan Z Reinstein, MD
role: STUDY_DIRECTOR
affiliation: Pro Sight Eye Hospital, Chandigarh, India
name: Sheetal Brar, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Uma Eye Clinic, Chennai, India
name: Aadithreya Varman, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01059253: Pilot Study of AdvanStep in Improving Balance in at Risk Elderly
Official title: Feasibility and Pilot Study of AdvanStep in Improving Balance in Elderly at Risk for Falls
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE1
PHASE2
Conditions: Impaired Balance in Elderly
Keywords: Falls
Balance
Elderly
Aged
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2010-01-29
Enrollment: 0
Sex: ALL
Minimum age (years): 65
Maximum age (years): 80
Standard ages: OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Elderly individuals are often at increased risks for falls. The AdvanStep is an interactive training exercise and balance device. The use of the AdvanStep will bring about a measurable improvement in the individuals balance in standardized measures.

Detailed description: 1. Feasibility study, assessing usability of the system and receiving feedback from the volunteers.
2. Structured treatment sessions twice per week after an initial assessment of balance and mobility on standardized tests.
3. Reassessment of balance and mobility after completion of 15 treatment sessions.
4. Treatment sessions will be supervised by physical therapists.

Eligibility criteria: Inclusion Criteria:

* Age 65-80
* History of 2 falls in past 5 years, not requiring medical attention
* No acute orthopedic or neurological disorders
* No cognitive impairment affecting daily function.
* Adequate vision and hearing to see the computer screen and follow verbal commands.
* Unilateral stance test - inability to remain in unilateral stance for 25 seconds

Exclusion Criteria:

* Congestive heart failure or angina that limits physical activity
* Need for interventional medical treatment

Primary outcomes:
measure: Performance on 4 square step test, Balance Evaluation Systems Test, 25 second unilateral stand test
timeFrame: On completion of treatment
Secondary outcomes:
Other outcomes:
Locations:
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
Study officials:
affiliation: Sheba Medical Center
name: Harold Weingarden, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00612053: Italian Registry on Unprotected Left Main
Official title: Italian Registry on Treatment for Unprotected Left Main Disease (Registro Italiano Sul Trattamento Del Tronco coMune Non protettO)
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiovascular Disease
Coronary Artery Disease
Keywords: cardiovascular disease
coronary artery bypass grafting (CABG)
coronary artery disease (CAD)
percutaneous transluminal coronary angioplasty (PCI)
unprotected left main disease
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2008-02-11
Enrollment: 1200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Patients with suspected coronary artery disease undergoing diagnostic coronary angiography.

Brief summary: The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational study will appraise the prevalence, management strategy, and prognosis of unprotected left main coronary artery disease in Italy.

Detailed description: The RITMO (Registro Italiano sul trattamento del Tronco coMune non protettO) observational study will be a prospective, multicenter, observational study aiming to appraise the prevalence, management strategy, and prognosis (up to 5 years) of unprotected left main coronary artery disease in Italy. A total of 45 Italian secondary and tertiary care centers will participate, and enroll patients during a period of 12 to 18 months. Patients will be included provided that they complete a written informed consent form and significant unprotected left main coronary artery disease is established at diagnostic coronary angiography. The primary end-point will be the 12-month rate of major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization).

Eligibility criteria: Inclusion Criteria:

* angiographic evidence of significant unprotected left main disease
* lack of patent bypass grafts for the left coronary system
* willingness to complete written informed consent form
* willingness to comply with subsequent follow-up contacts

Exclusion Criteria:

* lack of written informed consent form
* inability to comply with subsequent follow-up contacts

Primary outcomes:
measure: major adverse cerebro-cardiovascular events (ie death, myocardial infarction, stroke, or coronary revascularization)
timeFrame: 12 months
Secondary outcomes:
measure: major adverse cerebro-cardiovascular events
timeFrame: 60 months
measure: Canadian Cardiac Society functional class
timeFrame: 60 months
measure: quality of life (EuroQoL)
timeFrame: 60 months
Other outcomes:
Locations:
city: Turin
country: Italy
facility: Division of Cardiology, University of Turin
state: To
Study officials:
affiliation: University of Turin, Italy
name: Giuseppe Biondi Zoccai, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01831453: Omega-3 and Quality of Life in Recurrent Aphthous Stomatitis Patients
Official title: Therapeutic Effect of Systemic Omega-3 Polyunsaturated Fatty Acids On Quality of Life in Patients Suffering From Recurrent Aphthous Stomatitis Unresponsive to Topical Therapy.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Recurrent Mouth Ulcers
Keywords: omega-3
recurrent aphthous stomatitis
quality of life
Lead sponsor: October 6 University
Sponsor class: OTHER
Collaborators: name: Tanta University
First posted: 2013-04-15
Enrollment: 50
Sex: ALL
Minimum age (years): 13
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The study aims at evaluating the effect of omega-3 on patients suffering recurrent oral aphthous ulcers

Detailed description: In this study, we tested the hypothesis that the administration of omega 3 improve the quality of life in patients suffering recurrent oral ulceration and improve associated symptoms of pain in addition to reduction of ulcers episode.

Eligibility criteria: Inclusion Criteria:

1. Male and female patients older than 13 years of age
2. Presenting with 1 to 3 aphthous ulcers (less than 48 hours' duration) with a size no greater than 5mm in diameter.
3. History of recurrent minor aphthous ulcer for at least one year with a frequency of at least one outbreak every one month.
4. Normal sense of pain, without anesthesia or paresthesia.
5. Willingness to participate and sign the informed consent.

Exclusion Criteria:

* 1- Concurrent clinical conditions that could pose a health risk to the subjects including serious heart, liver, or kidney dysfunctions.

  2- Pregnancy and lactation. 3- Ulcers as a manifestation of systemic disorders such as Ulcerative Colitis, Crohn's disease, Behçet's syndrome or serious anemia.

  4- Treatment with systemic steroids, immunomodulatory agents, antibiotics, non-steroidal anti-inflammatory drugs (except occasional use for headaches) one month prior to the study entry.

  5- Treatment of the current ulcer with any topical or systemic medication. 6- Attendance of any other clinical trials prior to 3 months of study entry.

Primary outcomes:
measure: quality of life
timeFrame: six months
Secondary outcomes:
measure: Pain associated with the ulcers
timeFrame: Six months
measure: Duration of ulcers episode
timeFrame: Six months
measure: The monthly number of ulcer outbreaks
timeFrame: Monthly for six months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: October 6 university
state: Governarate of 6 of October
Study officials:
affiliation: October 6 University
name: Amr M Elkhouli, ass prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hjorth E, Zhu M, Toro VC, Vedin I, Palmblad J, Cederholm T, Freund-Levi Y, Faxen-Irving G, Wahlund LO, Basun H, Eriksdotter M, Schultzberg M. Omega-3 fatty acids enhance phagocytosis of Alzheimer's disease-related amyloid-beta42 by human microglia and decrease inflammatory markers. J Alzheimers Dis. 2013;35(4):697-713. doi: 10.3233/JAD-130131.
Clinical trial NCT03999853: Butyrate Adjuvant Therapy for Type 1 Diabetes
Official title: Colonic Delivery of Butyrate to Improve Insulin Sensitivity and Lower Triglycerides in Type 1 Diabetes Subjects
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
PHASE2
Conditions: Type1diabetes
Keywords: Butyrate
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
Collaborators: name: BioKier Inc.
name: Juvenile Diabetes Research Foundation
First posted: 2019-06-27
Enrollment: 20
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: BKR-017: Delayed release butyrate which promotes endogenous incretin secretion to determine if this improves insulin action
Primary purpose: TREATMENT

Brief summary: The investigators are interested to evaluate the effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy on metabolic control in type 1 diabetes (TID) subjects.

Detailed description: This study will test effect of BKR-017 (colon-targeted 500 mg butyrate tablets) as adjuvant therapy in type 1 diabetes (TID) Subjects on metabolic control in this population. Insulin sensitivity, glucose control (variability) and triglycerides will be measured after 8 weeks of treatment and compared to baseline.

Eligibility criteria: Inclusion Criteria:

1. All type 1 diabetes with C-Peptide (CPR) less than 0.5 ng/mL subjects who are \> 20 and \<80 years of age recruited from the Mayo Clinic Endocrinology Clinic;
2. Will also meet HbA1c level of 6.4-8.9% and BMI of \< 30 kg/m2 at week -4.

Exclusion Criteria:

1. Except for the use of insulin, no other treatments for T1D will be permitted.
2. Pregnancy
3. Inability or unwillingness of individual or legal guardian/representative to give written informed consent.

Primary outcomes:
measure: Insulin sensitivity
timeFrame: (Day 0) to Day 28 and Day 56
Secondary outcomes:
measure: Glucose Variability and Triglycerides
timeFrame: (Day 0) to Day 28 and Day 56
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic
name: Adrian Vella, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT02257151: Study to Evaluate the Safety, Pharmacokinetics and Target Engagement of BMS-986142 in Healthy Subjects
Official title: Randomized, Double-Blind, Placebo-Controlled, Single and Multiple Ascending Dose Study to Evaluate the Safety, and Pharmacokinetics of BMS-986142 in Healthy Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Healthy Adult
Keywords: Volunteers
Lead sponsor: Bristol-Myers Squibb
Sponsor class: INDUSTRY
First posted: 2014-10-06
Enrollment: 118
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to evaluate the safety, pharmacokinetics, and target engagement of BMS-986142 in healthy subjects.

Detailed description: Allocation: Randomized Controlled Trial (SAD/MAD) Masking: Double-Blind (SAD/MAD)

Eligibility criteria: For more information regarding BMS clinical trial participation, please visit www.BMSStudyConnect.com

Inclusion Criteria:

1. Healthy male and female subjects as determined by no clinically significant deviation from normal in medical history, physical examination, ECGs, and clinical laboratory determinations
2. Body Mass Index (BMI) of 18 to 32 kg/m2, inclusive. BMI=weight (kg)/\[height(m)\]2

Exclusion Criteria:

1. Any significant acute or chronic medical illness
2. Current or recent (within 3 months of study drug administration) gastrointestinal disease
3. Any major surgery within 4 weeks of study drug administration
4. Any gastrointestinal surgery that could impact upon the absorption of study drug
5. Donation of blood to a blood bank or in a clinical study (except a screening visit) within 4 weeks of study drug administration (within 2 weeks for plasma only)

Primary outcomes:
measure: Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after single dose of BMS-986142
timeFrame: Single Ascending Dose(SAD) within 8 days
measure: Primary safety endpoint is based on the incidence, potential significance, and clinical importance of adverse events after multiple doses of BMS-986142
timeFrame: Multiple Ascending Dose (MAD) within 19 days
Secondary outcomes:
Other outcomes:
Locations:
city: Cypress
country: United States
facility: Wcct Global, Llc
state: California
Study officials:
affiliation: Bristol-Myers Squibb
name: Bristol-Myers Squibb
role: STUDY_DIRECTOR
References:
Clinical trial NCT01696851: Physiological and Psycho-social Variables of People With a Spinal Cord Injury Participating in Competitive Rugby in Wheelchairs
Official title: Physiological and Psycho-social Variables of People With a Spinal Cord Injury
Study type: OBSERVATIONAL
Overall status: WITHDRAWN
Conditions: Wheelchair Rugby Players With Tetraplegia
Lead sponsor: Sheba Medical Center
Sponsor class: OTHER_GOV
First posted: 2012-10-01
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Wheelchair rugby players with SCI with four limbs paralyzed playing and practicing regularly. Season lasts about six months.

Belonging to this group are training and playing regularly twice a week about 3 hours at a time, total of 6 hours per week under the supervision of two coaches who attend every practice and game.

Brief summary: People with Spinal cord injury with tetraplegia suffer from respiratory problem due to weakness of the muscles and because the autonomic system dysfunction.

Exercise is one way of preserving and improving physical fitness and directly and indirectly reduce risk factors such as insulin resistance, weight loss and low values of HDL. subjects with spinal cord injury with tetraplegia have limited options for exercise: table tennis, gym, pool and more. Because of the nature of the injury which includes the sympathetic failure, they can not easily get the desired pulse to improve physical fitness.

Wheelchair rugby in Canada was developed specifically for people with tetraplegia who could not participate in wheelchair basketball. The game combines short, quick races with different aerobic capabilities. Previous studies have shown that participants in wheelchair rugby Improve anaerobic power, oxygen consumption, physical fitness and daily functioning. Wheelchair rugby improves self-confidence and as a result it affects other areas of life. Another study examined sense of self-efficacy, saw improvement in this index for rugby players in a wheelchair at high levels.

In the present study the investigators aim to examine whether regular participation in wheelchair Rugby for a season has more impact than other routine exercise (table tennis, gym, swimming).


Eligibility criteria: Inclusion Criteria:

* subjects with tetraplegia who play wheelchair rugby

Exclusion Criteria:

* suffering from a medical condition that prevents from performing the tests required by the study protocol.

Primary outcomes:
measure: lung function during rest using a spirometer
timeFrame: one minute
measure: Functional testing
timeFrame: 5 minutes
measure: Depression
timeFrame: 5 minutes
measure: Self efficacy
timeFrame: 5 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Netanya
country: Israel
facility: College of Physical Education Wingate
Study officials:
affiliation: Sheba Medical Center
name: Gabi Zeilig, Dr.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06028451: ManagemEnt of Antifungal Drug in Invasive Aspergillosis：a Real-word Study
Official title: ManagemEnt of Antifungal Drug in Invasive Aspergillosis：a Real-word Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Invasive Aspergillosis
Keywords: invasive aspergillus infection
Lead sponsor: Southeast University, China
Sponsor class: OTHER
First posted: 2023-09-08
Enrollment: 550
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients diagosed as invasive aspergillosis

Brief summary: To assessed the current situation and outcome of critically ill patients with invasive aspergillus infection.

Detailed description: To assessed the current situation and outcome of critically ill patients with invasive aspergillus infection.

Eligibility criteria: Inclusion Criteria:

* Age\>18 year-old
* Diagosed as invasive aspergillus infection

Exclusion Criteria:

* Pregnant

Primary outcomes:
measure: mortality
timeFrame: 28 day
Secondary outcomes:
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Southeast University, Zhongda hospital
state: Jiangsu
Study officials:
affiliation: Southeast University
name: Jingyuan Xu, M.D.
role: PRINCIPAL_INVESTIGATOR
References: