louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT03747861: Measuring Accuracy of Wristband for Registration of ECG RR-Intervals for One Hand, SenceBand in Comparison to Holter
Official title: An Open Clinical Study of Measuring Accuracy of RR- Intervals and Determining the Heart Rate Variability With a Wristband for Registration of ECG RR Intervals for One Hand, SenceBand Compared to the Holter Monitor.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: HRV
Keywords: R-R intervals
Heart rate
HRV
Lead sponsor: Planexta, Inc
Sponsor class: INDUSTRY
Collaborators: name: Pharmaxi LLC
First posted: 2018-11-20
Enrollment: 59
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: The purpose of the study is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand icompared to the Holter monitor (LabTech Ltd).

Detailed description: Non-randomized, prospective, open clinical trial . The main purpose is to evaluate the measuring accuracy of the Wristband for registration of ECG RR intervals for one hand, SenceBand in real-world condition during 24-hours of routine duties in comparison to a predicate device (Holter monitor). For monitoring HRV each subject will put heart rate monitor SenceBand in the randomly assigned wrist and Holter monitor electrodes will be placed in standard configurations places. Data will be collected during routine duties. SenceBand will collect data from 5-minutes intervals each 30 minutes, Holter will collect data continuously over 24 hours.

Eligibility criteria: Inclusion Criteria:

1. Subject has given written informed consent;
2. Subject is male or female, aged 18-75;
3. Subject has understood and complied with the requirements of the study protocol and;
4. Subject is fluent in Ukrainian.

Exclusion Criteria:

1. Subject has cardiac pacemakers;
2. Subject is a pregnant woman;
3. Subject has an allergy on polyurethane;
4. Subject refers to vulnerable groups of the population;
5. In investigator's opinion subject is not able physically or intellectually to fulfill the requirements of protocol.

Primary outcomes:
measure: RR interval accuracy
timeFrame: 5-minute intervals every 30 minutes within 24 hours
Secondary outcomes:
measure: RR-intervals passing
timeFrame: 5-minute intervals every 30 minutes within 24 hours of use
measure: HRV accuracy for time-domain measures
timeFrame: 5-minute intervals every 30 minutes within 24 hours
measure: HRV accuracy for frequency-domain measures
timeFrame: 5-minute intervals every 30 minutes within 24 hours
measure: HRV accuracy for time-domain measures
timeFrame: 24 hours intervals
measure: HRV accuracy for frequency-domain measures
timeFrame: 24 hours intervals
Other outcomes:
Locations:
city: Kyiv
country: Ukraine
facility: Doctor Sam Medical Network
state: Kyiv Region
Study officials:
affiliation: Dr. Sam LLC
name: Yulia Kuznetsova-Arabuli, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05900661: The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders
Official title: The Effect of Myo-inositol, Somatropin, and DHEA on Poor Ovarian Responders Undergoing ICSI : an Open Label Randomized Clinical Trial.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
PHASE3
Conditions: Poor Responders
Keywords: Cetrorelix
DHEA
somatotropin
myo inositol
Lead sponsor: Beni-Suef University
Sponsor class: OTHER
First posted: 2023-06-12
Enrollment: 300
Sex: FEMALE
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaulate the role of Myo-inositol, somatropin, DHEA on ICSI outcome in poor ovarian responder

Detailed description: Each patient will be subjected to:

Full history taking. Systematic clinical examination to assess the general condition, body mass index (BMI) and local pelvic physical findings and AFC by trans-vaginal ultrasound on D2 to 3 of menstruation.

Routine labs as CBC, liver \& kidney functions to exclude general disease as a contraindication for induction or pregnancy.

Blood sample will be obtained for assessment of basal serum levels of FSH, LH, E2 on days 2- 3 of the cycle. PRL, AMH and TSH Ovarian Stimulation The patients will begin injections of recombinant FSH (rFSH, Gonal-F; Merck-Serono, Italy) from day 2-3 of menstruation, with daily dose of 150-300 IU adjusted according to individual conditions on the basis of the antral follicle count (AFC),hormonal profile, age, body mass index (BMI), and previous ovarian response, according to the standard operating procedures of the center. .

For pituitary suppression, the patients will receive GnRH antagonist Cetrorelix (CETROTIDE 0.25Mg/d, Merck Serono, Germany) 0.25 mg/day subcutaneously from day 6 of induction until trigger day.

The serum LH, estradiol levels as well as number and size of follicles will be monitored every two days, starting from stimulation day 6 until the day of hCG injection.

Eligibility criteria: Inclusion Criteria:

* 1-Infertile women who have one of the criteria of poor ovarian response as follows ;
* Antral follicle count less than 7
* Anti-Mullerian hormone level Less than 1.2 ng/ml 2- females with body mass index (BMI) from 19-25

Exclusion Criteria:

1. Any endocrine or metabolic disorder such as polycystic ovary syndrome,
2. Hyperprolactinemia, diabetes and thyroid dysfunction.
3. Any pelvic pathology such as hydrosalpinx, uterine anomaly.
4. any male factor infertility such as Oligo-Astheno-Teratozoospermia (OAT) or Azoospermia.

Primary outcomes:
measure: Number and maturity of oocytes retrieved
timeFrame: 1 month
Secondary outcomes:
measure: chemical pregnancy rate
timeFrame: 1 month
Other outcomes:
Locations:
city: Banī Suwayf
country: Egypt
facility: Beni-suef university Hospital
state: Beni Suef
Study officials:
affiliation: Faculty of Medicine Beni-Suef University
name: Beni-Suef University
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03270761: Zhongshan Iridocorneal Endothelial Syndrome Study (ICEs)
Official title: A Multi-center Study on Iridocorneal Endothelial (ICE) Syndrome in China
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Glaucoma
Lead sponsor: Sun Yat-sen University
Sponsor class: OTHER
Collaborators: name: ICE study group
First posted: 2017-09-01
Enrollment: 98
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ICE syndrome patients identified and enrolled from 50 study centers in China.

Brief summary: This is a multi-center study to report the demographic profile, clinical features, and management in patients with Iridocorneal endothelial (ICE) syndrome in China.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of ICE syndrome;
* Those willing to sign the informed consent.

Exclusion Criteria:

* Patients who don't sign the informed consent or abide by the study procedure.

Primary outcomes:
measure: Management in patients with Iridocorneal endothelial (ICE) syndrome
timeFrame: through study completion, an average of 1 year
Secondary outcomes:
measure: Demographic profile of patients
timeFrame: 1 day
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center
state: Guangdong
Study officials:
affiliation: Zhongshan Ophthalmic Center, Sun Yat-sen University
name: Xiulan Zhang, MD,PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06382961: Postoperative Dexmedetomidine in Prevention of Postoperative Delirium
Official title: Postoperative Infusion of Dexmedetomidine for Prevention of Postoperative Delirium in Elderly Patients Undergoing Lung Surgery: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Delirium in Old Age
Anesthesia; Adverse Effect
Lead sponsor: Boston Intelligent Medical Research Center, Shenzhen United Scheme Technology Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Shenzhen People's Hospital
name: Dongyuan People's Hospital
name: Kunming Children's Hospital
First posted: 2024-04-25
Enrollment: 287
Sex: ALL
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this clinical trial is to learn how postoperative infusion of dexmedetomidine would influence postoperative delirium in elderly patients undergoing lung surgery. The main questions it aims to answer are :

1. Does postoperative dexmedetomidine reduce the incidence of delirium after lung surgery?
2. Does postoperative dexmedetomidine introduce other medical problems? Researchers will compare dexmedetomidine and sufentanil to see if dexmedetomidine works to reduce delirium.

Participants will undergo routine postoperative care:

1. Patient-controlled self anesthesia with sufentanil only or combination of sufentanil and dexmedetomidine
2. Postoperative visit twice a day for at least seven days


Eligibility criteria: Inclusion Criteria:

* elective surgery for lobectomy or segmentectomy

Exclusion Criteria:

* local allergy to anesthetics;
* patients with a clear preoperative history of nervous system and mental system diseases or long-term use of sedatives or antidepressants;
* history of alcoholism, drug abuse or drug dependence;
* have a history of brain surgery or injury;
* epilepsy and associated mental and cognitive dysfunction, long-term stress stimulation, or psychological disorders;
* sick sinus syndrome, second-degree or greater atrioventricular block or other contraindications for use of α2 adrenergic agonist;
* liver and kidney insufficiency.

Primary outcomes:
measure: Incidence of postoperative delirium
timeFrame: Delirium is assessed at 8 am and 8 pm for 3 days after surgery
Secondary outcomes:
measure: Incidence of postoperative nausea and vomiting
timeFrame: Assessed twice a day for 7days after surgery
measure: incidence of postoperative complications
timeFrame: Assessed daily for 3 days after surgery
measure: Pain intensities
timeFrame: Assessed daily at 8 am for 3 days after surgery
Other outcomes:
Locations:
city: Kunming
country: China
facility: Kunming Children's Hospital
state: Yunnan
Study officials:
affiliation: Department of Anesthesiology, Kunming Children's Hospital
name: Rui Zhao
role: STUDY_DIRECTOR
References:
Clinical trial NCT04530461: Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
Official title: Serologic Profile of SARS CoV2 in COVID-19 Patients With Systemic Diseases
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: SARS-CoV Infection
Systemic Disease
Systemic Lupus Erythematosus
Sjogren's Syndrome
Sarcoidosis
Inflammatory Myopathy
Behçet Disease
Rheumatoid Arthritis
Spondyloarthritis
Lead sponsor: Military Hospital of Tunis
Sponsor class: OTHER
Collaborators: name: UR17DN02 : Autoimmune Diseases Research Unit
First posted: 2020-08-28
Enrollment: 200
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 with one of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.

Brief summary: An observational study aiming to assess the serological profile of SARS-Cov2 patients with systemic diseases such as systemic lupus erythematosus, Sjogren syndrome, sarcoidosis, inflammatory myopathies, Behçet's disease, Rheumatoid arthritis and Spondyloarthritis

Detailed description: The study is a prospective, observational, multicenter clinical trial to be conducted in the internal medicine, rheumatology and virology departments of Military Hospital of Tunis. After obtaining informed consent from the patient, the investigator will perform an inclusion visit made of a patient interview and performing blood sample to search for IgG and anti-SARS IgM CoV2.

Patients with IgM-like antibodies will have an RT-PCR test for active infection. If the study participants will be diagnosed with COVID-19 positive during the study period, the attending physician is entitled to decide on their management based on the severity of the clinical status.

Eligibility criteria: Inclusion Criteria:

* Age over 18 years old
* One of the following conditions: systemic lupus, Sjögren's syndrome, rheumatoid arthritis, inflammatory myopathies, spondyloarthritis, sarcoidosis and Behçet's disease.
* Informed consent obtained and signed

Exclusion Criteria:

* Refusal to repeat blood sampling if the first one was badly performed
* Informed consent not obained

Primary outcomes:
measure: Serological Profile
timeFrame: Inclusion
Secondary outcomes:
Other outcomes:
Locations:
city: Tunis
country: Tunisia
facility: Military Hospital of Tunis
Study officials:
affiliation: Military Hospital of Tunis
name: Faida Ajili, MD
role: STUDY_CHAIR
References:
Clinical trial NCT04616261: Beta2-adrenergic System and Training
Official title: Trainability of the beta2-adrenergic System With Respect to Performance
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Lead sponsor: University of Copenhagen
Sponsor class: OTHER
First posted: 2020-11-04
Enrollment: 30
Sex: MALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: BASIC_SCIENCE

Brief summary: This project aims to examine the trainability of the beta2-adrenergic system with respect to the individual performance response


Eligibility criteria: Inclusion Criteria:

* 18 to 45 years of age
* Trained individuals with a maximal oxygen uptake above 55 ml/min/kg
* Body mass index lower than 26

Exclusion Criteria:

* Allergy towards study drug
* Unacceptable side effects to the study drug
* Chronic disease deemed by the MD to interfere with the study
* Smoking
* Use of prescription medicine

Primary outcomes:
measure: Sprint performance
timeFrame: ½ hour after administration of formoterol or placebo
Secondary outcomes:
measure: Cycling endurance performance
timeFrame: ½ hour after administration of formoterol or placebo
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03786861: Corneal WFG Versus AF Trans PRK in Myopic Patients With High Corneal HOA
Official title: Corneal Wavefront Guided Versus Aberration Free Transepithelial Photorefractive Keratectomy in Myopic Patients With High Pre-existing Corneal Higher Order Aberrations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Myopia
Keywords: aberration free
corneal wavefront guided
higher order aberrations
photorefractive keratectomy.
Lead sponsor: Menoufia University
Sponsor class: OTHER
First posted: 2018-12-26
Enrollment: 33
Sex: ALL
Minimum age (years): 21
Maximum age (years): 52
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: compare the efficacy, safety and predictability of corneal wavefront guided (WFG) and aberration free ablation in single-step transepithelial photorefractive keratectomy (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).

Detailed description: Objectives:to compare the efficacy, safety and predictability of corneal wavefront guided (WFG) and aberration free ablation in single-step transepithelial photorefractive keratectomy (TransPRK) in myopic patients with high pre-existing corneal higher order aberrations (HOAs).

Background: Corneal WFG and aberration free treatments have been proposed as methods to achieve better visual, refractive, and optical outcomes.

Methods: prospective case series was conducted in El-Hekma Eye-LASIK center, Menoufia governorate, Egypt during the period from January 2017 to December 2017. TransPRK was performed to eligible myopic patients with or without astigmatism with corneal HOAs ≥ 0.35 µ utilizing either aberration free or corneal WFG patterns provided by ORKCAM software (SCHWIND eye-tech-solutions, Kleinostheim, Germany). Uncorrected distance visual acuity (UDVA), manifest and cycloplegic refractions, best spectacle corrected distance visual acuity (CDVA), thorough slit lamp examination and corneal topography were assessed and repeated six months postoperatively.

Eligibility criteria: Inclusion Criteria:

* Myopic patients with or without astigmatism

Exclusion Criteria:

* severe dry eye,
* blepharitis,
* corneal disease,
* contact lens warpage,
* cataract,
* uveitis
* posterior segment anomalies involving the macula or optic nerve
* systemic conditions; diabetes mellitus, connective tissue disease, pregnancy or nursing. Also, any patient who had previous ocular surgery including keratorefractive surgery was excluded

Primary outcomes:
measure: corneal wavefront customized treatments and aberration free aspheric treatments
timeFrame: 1year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00015561: Pesticides--Health Fertility and Reproductive Risk
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Birth Defects
Miscarriages
Cancer
Keywords: population studies
laboratory evaluation
hormone analysis
semen analysis
chromosome studies
Lead sponsor: National Institute of Environmental Health Sciences (NIEHS)
Sponsor class: NIH
First posted: 2001-04-23
Enrollment: 1803
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: DEFINED_POPULATION
Time perspective: OTHER

Brief summary: This project is designed to establish whether pesticides or other environmental agents have a role in the excess birth defects identified in the Red River Valley of Minnesota. In this human study, laboratory based health parameters will be used to key in health survey data. In vitro data will be developed to mechanistic information. Concordant results among these study features will provide a weight of evidence approach.


Eligibility criteria: Pesticide applicators and their spouses

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Minneapolis
country: United States
facility: University of Minnesota Medical School
state: Minnesota
Study officials:
affiliation: University of Minnesota
name: Vincent F Garry, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Lyubimov AV, Garry VF, Carlson RE, Barr DB, Baker SE. Simplified urinary immunoassay for 2,4-D: validation and exposure assessment. J Lab Clin Med. 2000 Aug;136(2):116-24. doi: 10.1067/mlc.2000.108150.
citation: Lin N, Garry VF. In vitro studies of cellular and molecular developmental toxicity of adjuvants, herbicides, and fungicides commonly used in Red River Valley, Minnesota. J Toxicol Environ Health A. 2000 Jul 28;60(6):423-39. doi: 10.1080/00984100050033494.
citation: Kirkhorn SR, Garry VF. Agricultural lung diseases. Environ Health Perspect. 2000 Aug;108 Suppl 4(Suppl 4):705-12. doi: 10.1289/ehp.00108s4705.
citation: Garry VF, Burroughs B, Tarone R, Kesner JS. Herbicides and adjuvants: an evolving view. Toxicol Ind Health. 1999 Jan-Mar;15(1-2):159-67. doi: 10.1191/074823399678846619.
citation: Schreinemachers DM, Creason JP, Garry VF. Cancer mortality in agricultural regions of Minnesota. Environ Health Perspect. 1999 Mar;107(3):205-11. doi: 10.1289/ehp.99107205.
Clinical trial NCT07004361: Ethical Issues of Using Gene Therapy in the Treatment of AMD
Official title: Ethical Issues of Using Gene Therapy in the Treatment of AMD (Age-related Macular Degeneration)
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Exudative Age-related Macular Degeneration
Keywords: ethical
Age-related Macular Degeneration
Lead sponsor: Nantes University Hospital
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: exsudative AMD patients in o\^pthalmology department in CHU Nantes

Brief summary: The objective of this study is to examine the legitimacy of gene therapy use in the treatment of exudative age-related macular degeneration (AMD). This involves questioning its beneficence/non-maleficence ratio given the limited experience with this innovative technology and its irreversible effects, requiring a surgical procedure for administration. Additionally, the study explores patient autonomy in decision-making concerning complex therapeutic approaches and how patients should be supported to best uphold this autonomy.

Detailed description: Qualitative research based on semi-structured interviews conducted with patients diagnosed with age-related macular degeneration (AMD), followed in the ophthalmology department of Nantes University Hospital and treated with intravitreal injections. These interviews are structured around three main themes in order to better understand:

The experience and perception of the current treatment by the patients

Their perceptions, expectations, and potential concerns regarding gene therapy

Their perception and understanding of decision-making autonomy in their health decisions

Eligibility criteria: Inclusion Criteria:

* Patients with exsudative AMD, male female \>18 years Patients for whom the doctor could consider gene therapy.

Exclusion Criteria:

Patients with atrophic AMD (Age-related Macular Degeneration) Patients with other degenerative retinal diseases than AMD, Patients with with associated cognitive disorders.

Primary outcomes:
measure: The experience and current treatment outcomes perceived by patients
timeFrame: 1 months
Secondary outcomes:
measure: Patients' perceptions, expectations, and potential concerns regarding gene therapy
timeFrame: 1 month
measure: Patients' perception and representation of decisional autonomy in their health decisions
timeFrame: 1 month
Other outcomes:
Locations:
Study officials:
References: