louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT01042834: Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects
Official title: Impact of Air Pollution on the Autonomic Nervous System Activity and the Presence of Sleep Apnea in Older Subjects: Longitudinal Multicentric Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Healthy
Keywords: air pollution
autonomic nervous system
sleep apnea
Heart rate variability
Healthy volunteers
Lead sponsor: Centre Hospitalier Universitaire de Saint Etienne
Sponsor class: OTHER
Collaborators: name: Ministry of Health, France
First posted: 2010-01-06
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The subjects will have to live in districts where important atmospheric pollution is established

Brief summary: Impact of air pollution on the autonomic nervous system activity and presence of sleep apnea in older subjects.

Detailed description: The relation between the air pollution and morbidity, cardiovascular mortality was increasing interest. Analyses show an increase of respiratory difficulty, but also cardiac deaths in the daytime when the atmospheric pollution was increased. It was demonstrated that health effects of ambient air pollution in subjects presenting cardiac or lung difficulty were important. Mechanisms show a possible relation to autonomic nervous system (ANS) deactivation and mortality. Particularly, the ageing and ANS reach would be more predictive of cardiovascular events. Thus, we suggest estimating in 60 healthy volunteers from 60 to 80 years old, the impact of the air pollution on the autonomic nervous system activity and sleep apnea consequences.

Eligibility criteria: Inclusion Criteria:

* reside in Lyon and Saint-Etienne cities
* security social affiliated or beneficiary
* information note signed

Exclusion Criteria:

* heart rate disorders
* pacemaker
* tabacco addiction or second-hand smoke
* morbid obesity (BMI \> 30)
* insulin-dependent diabetes
* chronic disease on treatment
* antiarrythmic treatments

Primary outcomes:
measure: Frequency analysis of heart rate variability
timeFrame: inclusion, 1 test night and 2 experimental nights
Secondary outcomes:
measure: Analysis of sleep, diurnal somnolence, sleep latency and PRS impact on the life quality.
timeFrame: 1 test night and 2 experimental nights
measure: Hour index quantification of night respiratory events.
timeFrame: 1 test night and 2 experimental nights
measure: Hour index quantification of autonomic awakening during the sleep.
timeFrame: 1 test night and 2 experimental nights
Other outcomes:
Locations:
city: Lyon
country: France
facility: Hospices Civiles de Lyon
city: Saint-Etienne
country: France
facility: CHU Saint-Etienne
Study officials:
affiliation: CHU de Saint-Etienne
name: Jean-Claude BARTHELEMY, MD-PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06719934: Ttt of Adenomyosis
Official title: Dienogest Versus Uterine Artery Embolization in Ttt of Adenomyosis -cohort Comparetive Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE1
Conditions: Adenomyosis
Lead sponsor: Al-Azhar University
Sponsor class: OTHER
First posted: 2024-12-06
Enrollment: 100
Sex: FEMALE
Minimum age (years): 30
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: to evaluate use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms

Detailed description: Type of the study: prospective cohort comparative study. Setting: It will be done at both Obstetrics \& Gynecology department and Radiology department, Al-Azhar University Hospital Assiut branch.

Time of the study: Starting from January 2025 till the end of the study Number of cases: 100 cases. According to sample size equation Where; in: n = number of patients, = 1.96 (standard normal deviate value that divides the central 95% of z distribution from 5% in the tails), P = the reported sensitivity (67%, i.e., 0.67), L= absolute precision desired on either side (half width of the confidence interval of the confidence interval) of sensitivity (10% i.e., 0.1).

Inclusion criteria:

* Age Group: 30-50 years
* Women with adenomyosis
* With or without small fibroids
* Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.

Exclusion criteria:

* Presence of a malignancy or pelvic infection.
* An on-going pregnancy or a desire to conceive in the future.
* Absolute contraindication for angiography (renal impairment).
* Chronic debilitating diseases.

Eligibility criteria: Inclusion Criteria:- Age Group: 30-50 years

* Women with adenomyosis
* With or without small fibroids
* Suffering from heavy menstrual bleeding, dysmenorrhea, and/or cycle- independent pain and bulk-related symptoms.

Exclusion Criteria:

* - Presence of a malignancy or pelvic infection.
* An on-going pregnancy or a desire to conceive in the future.
* Absolute contraindication for angiography (renal impairment).
* Chronic debilitating diseases.

Primary outcomes:
measure: evaluation use of Dienogest versus uterine arteries embolization in treatment of Adenomyosis-associated symptoms as dysmenorrhea, heavy menstrual bleeding and bulk-related symptoms by questionnaire
timeFrame: through study completion ,an average of 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Assuit
country: Egypt
facility: Al Azhar university
Study officials:
References:
Clinical trial NCT06192134: Continuous Passive Motion Device for Children With Arthrogryposis
Official title: Continuous Passive Motion Device for Children With Arthrogryposis
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Arthrogryposis
Lead sponsor: Nemours Children's Clinic
Sponsor class: OTHER
First posted: 2024-01-05
Enrollment: 5
Sex: ALL
Minimum age (years): 3
Maximum age (years): 7
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Pilot study of intervention compared to historic controls
Primary purpose: PREVENTION

Brief summary: The Investigators are investigating a continuous passive motion device to exercise the knee of young children with arthrogryposis after they have had knee surgery.

Detailed description: The investigators will measure the effect of continuous passive motion (CPM) of the knee joint post-surgery on young children with arthrogryposis. The investigators have developed a motorized brace that will move the joint through a prescribed range of motion and speed while the subject is seated. The objective of this pilot study is to develop the device from subject feedback and determine the right dose and speed of CPM to provide. CPM is routinely used for adults and older children after surgery to maintain range of motion. The machines used are too large for young children therefore the investigators have developed a prototype for small sized kids that will exercise their knee joint post-surgery.

Eligibility criteria: Inclusion Criteria:

* Children with arthrogryposis
* Children between 3 and 7 years of age
* Children who have had recent knee surgery

Exclusion Criteria:

* Children older than 7
* Children unable to cooperate with protocol steps

Primary outcomes:
measure: range of motion
timeFrame: 2 weeks
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03098134: The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia
Official title: The Efficacy of a VR Enhanced Video Exposure Therapy for Dental Phobia - a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: Dental Phobia
Lead sponsor: Ruhr University of Bochum
Sponsor class: OTHER
Collaborators: name: Ruhr University of Bochum (Dr. Andre Wannemüller)
name: Zahnklinik Bochum, Augusta Hospital (Prof. Dr. Peter Jöhren)
name: Ruhr University of Bochum (Prof. Dr. Jürgen Margraf)
First posted: 2017-03-31
Enrollment: 100
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: Evaluation of a one session VR - enhanced Video exposure therapy for dental phobia. Diagnosed dental phobics will be randomly assigned to one of two conditions: (1) Psychoeducation + VR exposure (2) Psychoeducation + Video Control treatment. Prior to getting the therapy, participants will be evaluated with a questionnaire battery, diagnosed with a structured clinical interview and will participate in a psychophysiological symptom assessment. Then, after a 2-week waiting period, participants again fill in questionnaires, and the Intervention will take place. Within 2-weeks after the second questionnaire assessment participants will be screened with the structured interview again and will fill in questionnaires.


Eligibility criteria: Inclusion Criteria:

- diagnosed Specific Dental Phobia

Exclusion Criteria:

* Schizophrenia or other Psychotic Illnesses
* Bipolar Disorder
* Chronic Headache
* other neurological disorders such as epilepsy
* Hearing problems

Primary outcomes:
measure: Change in Subjective Dental Anxiety
timeFrame: 4 month
measure: Change in Dysfunctional Dental Cognitions
timeFrame: 4 months
Secondary outcomes:
measure: Change in Psychophysiological defensive reactivity
timeFrame: 4 weeks
Other outcomes:
measure: Change in dental avoidance behavior
timeFrame: within three month after the therapy took place
Locations:
Study officials:
References:
Clinical trial NCT07004634: Comparison of Drainage Methods in Minimally Invasive Esophagectomy (DEMURE）
Official title: Comparison of the Application Effects of Different Drainage Modes in the Perioperative Period of Minimally Invasive Three-Field Radical Esophagectomy for Esophageal Cancer
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Esophageal Cancer
Drainage/Methods
Postoperative Pain
Keywords: Esophageal cancer
Mediastinal drainage tube
Postoperative pain
Lead sponsor: Ruijin Hospital
Sponsor class: OTHER
First posted: 2025-06-04
Enrollment: 75
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: This RCT compares three drainage approaches after minimally invasive esophagectomy (chest tube + thoracic mediastinal drainage tube, thoracic, and abdominal mediastinal drainage tube) to evaluate perioperative outcomes, addressing current evidence gaps in pain and complication profiles.


Eligibility criteria: Inclusion Criteria:

* Age ≥18 years
* Pathologically confirmed esophageal cancer requiring three-incision esophagectomy (cervical, thoracic, and abdominal incisions)
* ASA physical status class I-III

Exclusion Criteria:

* History of chronic pain or long-term use of analgesics prior to surgery
* Severe cardiopulmonary dysfunction (e.g., FEV1 \<50%)
* Coagulation disorders or patients undergoing reoperation
* Intraoperative findings of extensive pleural adhesions, combined resection of adjacent organs, or other conditions deemed by the investigator to warrant exclusion

Primary outcomes:
measure: Postoperative Pain Scores
timeFrame: Pain scores were recorded at different times during the postoperative period when the patients were quiet and active (at 7 AM, 11 AM, 3 PM, and 7 PM) from postoperative day 1 to postoperative day 4.
Secondary outcomes:
measure: Postoperative complications
timeFrame: Postoperative complications from posoperative day 1 to postoperative month 3
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Ruijin Hospital
name: Hecheng Li, PhD, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01586234: OCT-guided DSAEK Graft Shaping and Smoothing
Official title: Randomized Clinical Trial of OCT-guided DSAEK Graft Shaping and Smoothing
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Fuchs' Endothelial Dystrophy
Keywords: Fuchs' endothelial dystrophy
DSAEK
Descemet's stripping automated endothelial keratoplasty
Lead sponsor: Oregon Health and Science University
Sponsor class: OTHER
First posted: 2012-04-26
Enrollment: 6
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 primary goal of this study is to determine if excimer laser smoothing of the cornea before Descemet's stripping automated endothelial keratoplasty (DSAEK)improves postoperative Best Spectacle Corrected Visual Acuity (BSCVA).

Detailed description: Many surgeons are moving away from full thickness corneal transplantation (because of risks involving rejection, irregular astigmatism, and wound dehiscence) to partial thickness transplantations of either the anterior or posterior (endothelial) layers. However this technique is not without its drawbacks. DSAEK uses a mechanical microkeratome to cut the graft, but vision is limited by the roughness of the cut surface.

DSAEK can lead to significant refractive error due to the non-uniform shape of the microkeratome cut graft, and the roughness of the microkeratome cut surface limits vision to an average of 20/31. Optical coherence tomography (OCT)-guided laser shaping and smoothing may improve the refractive and visual outcome.

Eligibility criteria: Inclusion Criteria:

* Adults with visual complaint and objective evidence of decreased vision due to corneal edema related to Fuchs' corneal endothelial dystrophy

Exclusion Criteria:

* Inability to give informed consent
* Inability to maintain stable fixation for OCT imaging
* Inability to commit to required visits to complete the study
* Eyes with concurrent cataract, retinal diseases, glaucoma, or other eye conditions that may limit the visual outcome after surgery

Primary outcomes:
measure: Number of patients with better post-operative spectacle-corrected visual acuity when implant graft is smoothed with eximer laser versus no smoothing of the graft.
timeFrame: 24 months
Secondary outcomes:
Other outcomes:
Locations:
city: Portland
country: United States
facility: Devers Eye Insitute
state: Oregon
Study officials:
affiliation: Devers Eye Institute, Legacy Health
name: Mark Terry, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01189734: Comparison Between Laparoscopic Common Bile Duct Exploration and Intraoperative ERCP for Management of Common Bile Duct Stones
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Common Bile Duct Gallstones
Keywords: common bile duct stones
laparoscopic common bile duct exploration
intraoperative ercp
Preoperatively diagnosed common bile duct stones
Lead sponsor: Mansoura University
Sponsor class: OTHER
First posted: 2010-08-27
Enrollment: 248
Sex: ALL
Minimum age (years): 12
Maximum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Many options are available for management of common bile duct stones. the most recent development in this field is single-session approach by one of two methods; laparoscopic common bile duct exploration and intraoperative endoscopic sphincterotomy. In this study, the investigators prospectively compare these two methods for management of patients with preoperatively diagnosed common bile duct stones to settle the best option.


Eligibility criteria: Inclusion Criteria:

* preoperatively diagnosed common bile duct stones

Exclusion Criteria:

* liver cirrhosis pregnancy ASA III, IV Previous abdominal surgery postcholecystectomy

Primary outcomes:
measure: success/failure of common bile duct removal
Secondary outcomes:
measure: Surgical time
Other outcomes:
Locations:
city: Mansoura
country: Egypt
facility: Gastroenterology Surgical Center
state: Dakahlia
Study officials:
References:
Clinical trial NCT05101434: Gingivitis and Periodontitis as a Risk Factor for Stroke
Official title: Gingivitis and Periodontitis as a Risk Factor for Stroke
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gingivitis
Periodontitis
Stroke
Lead sponsor: Shaheed Zulfiqar Ali Bhutto Medical University
Sponsor class: OTHER
First posted: 2021-11-01
Enrollment: 120
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: All the patients with stroke (both ischemic and hemorrhagic)

Brief summary: Periodontitis and gingivitis are one of the most infectious diseases in humans. Several studies have been carried out on the dependence of periodontitis and stroke. The aim of this study was to investigate gingivitis and periodontitis as risk factors for stroke in the Pakistani population.

Detailed description: Epidemiologic studies have shown that cerebrovascular accident (CVA) is the 3rd cause of death in developed countries with 0.8 % prevalence in the whole population. Although, the prevalence rate of stroke is reduced yet is one of the most important health problems in the United State. Periodontitis and gingivitis are the two most infectious man diseases. Today, it is estimated that about 35% of people over 30-year-old in America and 50-55% of people in developing countries are involved with these diseases.

These diseases are due to the practice of chronic bacterial infection and the inflammatory response of the host. The relationship between periodontitis and CVA was first introduced by Mackenzi and Millard in 1963 but the importance of this issue was not understood. Periodontal infection can be a complex multiphase disease by associating this infection with organ systems such as cardiovascular, endocrine, reproductive, and respiratory systems. Nowadays, periodontitis is considered a risk factor for atherosclerosis and thromboembolic disease.

Eligibility criteria: Inclusion Criteria:

* Diagnosed stroke by using brain imaging from magnetic resonance imaging and/or computerized tomography.

Exclusion Criteria:

* Not willing to participate
* Neurological complications other than stroke

Primary outcomes:
measure: Gingivitis
timeFrame: baseline
measure: Periodonitis
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Islamabad
country: Pakistan
facility: Shaheed Zulfiqar Ali Bhutto Medical University
state: Capital
Study officials:
affiliation: Shaheed Zulfiqar Ali Bhutto Medical University
name: Muhammad Hassan, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06706934: Search for Phenotype-modifying Genes in Patients With Intellectual Disabilities.
Official title: Search for Phenotype-modifying Genes in Patients With Intellectual Disabilities GWAS-2DI.
Study type: OBSERVATIONAL
Overall status: NOT_YET_RECRUITING
Conditions: Intellectual Disability
Keywords: Intellectual Disability
epistatic interaction
Lead sponsor: University Hospital, Bordeaux
Sponsor class: OTHER
First posted: 2024-11-27
Enrollment: 1400
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with intellectual disabilities or related but not affected by them

Brief summary: Each form of intellectual disability under study is a rare disease in its own right, and it is therefore difficult to study the variability of its expression. It therefore appears necessary to study large series of patients with intellectual disabilities. The objective is to identify variants in phenotype-modifying genes in patients with intellectual disability.

Detailed description: Thanks to the contribution of NGS analyses (exome and genome analysis), the rate of etiological diagnosis in intellectual disability is currently approaching 42% in some meta-analyses. At Bordeaux University Hospital, since 2017, 700 patients have been sequenced for intellectual disability, with a diagnostic rate of 33%.

In genetics, epistasis refers to the interaction between two or more genes. As part of its previous work, BIONOMEEX has developed an algorithm called GWAS-2D (genome wide association study 2 dimension) which makes it possible to observe, from a large number of samples and for a given phenotype, the relationships existing between two loci on the genome.

The GWAS-2DI project involves the reanalysis of exome sequencing data from patients with intellectual disabilities at Bordeaux University Hospital, using a GWAS-2D algorithm developed by BIONOMEEX to search for phenotype-modifying genes.

Eligibility criteria: Inclusion Criteria:

* Patients with Intellectual Disability or related but not affected by them
* Major or minor with autorisation of legal representative
* Exome sequencing in Bordeaux University Hospital between 2018 and 2024

Exclusion Criteria:

* Refusal to participate in research protocols
* Refusal to participate expressed following receipt of information letter.

Primary outcomes:
measure: Variants in phenotype-modifying genes
timeFrame: Inclusion visit
Secondary outcomes:
measure: Phenotypic traits
timeFrame: Inclusion visit
Other outcomes:
Locations:
city: Bordeaux
country: France
facility: Chu de Bordeaux
Study officials:
affiliation: University Hospital, Bordeaux
name: Vincent MICHAUD, MD
role: PRINCIPAL_INVESTIGATOR
References: