louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04651530: Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma
Official title: Endoscopic Cyclophotocoagulation in Normal Tension Glaucoma
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Normal Tension Glaucoma
Cataract
Keywords: endoscopic cyclophotocoagulation
ECP
Surgery
Lead sponsor: Helsinki University Central Hospital
Sponsor class: OTHER
First posted: 2020-12-03
Enrollment: 100
Sex: ALL
Minimum age (years): 55
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess whether endoscopic cyclophotocoagulation added to cataract surgery lowers intraocular pressure more than cataract surgery alone in patients with normal tension glaucoma.

Detailed description: Subjects with normal tension glaucoma that is stable with current medication needing cataract surgery are recruited in the study. All patients meeting the inclusion criteria and giving informed consent will be randomized to whether having endoscopic cyclophotocoagulation performed in the same session with cataract surgery, or cataract surgery alone.

Eligibility criteria: Inclusion Criteria:

* Signed Informed Consent
* Normal Tension Glaucoma with typical nerve fiber layer defects in red-free photographs and/or optical coherence tomography (OCT) and possible equivalent visual field defects, IOP never more than 21 mmHg, and open anterior chamber angle
* Glaucoma stable with current medication assessed by a glaucoma specialist
* Clinically significant cataract

Exclusion Criteria:

* Secondary Glaucoma e.g. due to previous injury or uveitis
* Exfoliation syndrome
* Pigment dispersion syndrome
* Previous transscleral or endoscopic cyclophotocoagulation
* Previous other glaucoma surgery
* Cataract due to eye injury or congenital cataract
* Zonular weakness due to Marfan syndrome or other
* Previous retinal detachment
* Previous intraocular surgery like vitrectomy and other retinal surgery
* Wet age-related macular degeneration
* Diabetic retonopathy
* Previous corneal transplant or previous refractive surgery
* Fuchs' dystrophy and other abnormalities compromising corneal clarity like scars
* The patient does not want to participate in the study
* The glaucoma progresses on current IOP
* The patient does not speak Finnish, Swedish or English
* Dementia
* Only eye with vision worse than 20/200 or loss of central visual field

Primary outcomes:
measure: Succes rate
timeFrame: One year postoperatively
Secondary outcomes:
measure: Additional surgery
timeFrame: Five years postoperatively
Other outcomes:
Locations:
city: Helsinki
country: Finland
facility: Helsinki University Hospital
Study officials:
affiliation: Helsinki University Central Hospital
name: Mika Harju, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT07011030: Diagnosis of Sarcopenia in Older Adults
Official title: Comparison of the Use of a Bioimpedance Meter With Integretaed Electrodes and Osteodensitometry for the Diagnosis os Sarcopenia in the Elderly
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Sarcopenia
Keywords: sarcopenia
elderly
bioimpedance analysis
osteodensitometry
Lead sponsor: Centre Hospitalier Universitaire de Nice
Sponsor class: OTHER
First posted: 2025-06-08
Enrollment: 72
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief summary: Sarcopenia is defined as the loss of muscle strength and mass associated with aging and is one of the main causes of frailty in older people, and therefore of their ability to age gracefully. Given the aging of the French population, the diagnosis and management of this condition is a major public health issue and, in this context, it is therefore necessary to be able to quickly assess people's skeletal muscle mass.

In its recommendations, French National Authority for Health recommends the use osteodensitometry and bioimpedance analysis (BIA) to assess skeletal muscle mass in the limbs for the purpose of diagnosing sarcopenia. Traditionally, BIA assessment is performed while lying down using adhesive electrodes placed on the hands and feet. The Biody XpertZM3 is a BIA device that allows seated measurement using integrated electrodes, enabling skeletal muscle mass to be assessed by bioimpedance analysis without the use of adhesive electrodes. However, the measurement position could alter the impedances measured and therefore the results obtained compared to other devices on the market as well as osteodensitometer


Eligibility criteria: Inclusion Criteria:

* Men or women aged 60 or over already receiving care at the Day Hospital of the Rehabilitation, Independence and Aging Center or the Frailty Platform of the Rehabilitation, Independence and Aging Center.
* Patients affiliated with or covered by a social security system.
* Patients who have signed an informed consent form in advance.

Exclusion Criteria:

* Vulnerable persons as defined in Articles L1121-5 to -8
* People with pacemakers, implantable defibrillators, or other electronic medical devices
* Musculoskeletal disorders that prevent bioimpedance measurement in a seated position
* Any condition of fluid retention or dehydration
* Absence of a measurement site (muscle resection or amputation)

Primary outcomes:
measure: Appendicular skeletal muscle mass
timeFrame: day 0
Secondary outcomes:
Other outcomes:
Locations:
city: Nice
country: France
facility: CHU de Nice
state: Alpes-Maritimes
Study officials:
affiliation: Centre Hospitalier Universitaire de Nice
name: Frédéric CHORIN, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00869830: The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease
Official title: The Effectiveness of Biofeedback Treatment in Constipated Patients With Idiopathic Parkinson's Disease
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Idiopathic Parkinson's Disease
Constipation
Keywords: Biofeedback
constipation
Parkinson's disease
Lead sponsor: Asan Medical Center
Sponsor class: OTHER
First posted: 2009-03-26
Enrollment: 30
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: The aims of the investigators' study are to characterize the nature of constipation in idiopathic Parkinson's disease (IPD) and to evaluate the usefulness of biofeedback therapy in constipated IPD patients.

Detailed description: The medical treatment of idiopathic Parkinson's disease (IPD) alleviates constipation symptoms due to the restoration of autonomic dysfunction. However, additional laxatives are usually needed in these patients. Other suppository treatments included stool softeners, dopamine-receptor agonists, botulinum toxins, and prokinetic medications such as tegaserod. Biofeedback therapy (BFT) has been the gold standard for functional constipation with dyssynergic defecation or rectal hyposensitivity. However, researchers have not tried to evaluate its usefulness in constipated IPD patients up to now. The aims of our study are to characterize the nature of constipation in IPD and to evaluate the usefulness of BFT in constipated IPD patients.

Eligibility criteria: Inclusion Criteria:

* Idiopathic Parkinson's disease

Exclusion Criteria:

* Secondary Parkinson's disease

Primary outcomes:
measure: To evaluate the effectiveness of biofeedback therapy in Parkinson's disease
timeFrame: usually six sessions per one biofeedback for 3 months
Secondary outcomes:
measure: to evaluate the constipation type in Parkinson's disease
timeFrame: 3-6 months
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Seung-Jae, Myung
Study officials:
affiliation: Asan Digestive Disease Research Institute, Department of Internal Medicine, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea
name: Kee Wook Jung, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT00412230: Insulin Resistance and Hypertensive Disorders in Pregnancy
Official title: The Role of Insulin Resistance in Gestational Hypertension and in Preeclampsia.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Hypertension in Pregnancy
Diabetes Mellitus in Pregnancy
Keywords: Pre-eclampsia
Gestational diabetes
Insulin resistance
hypertension in pregnancy
Lead sponsor: University of Messina
Sponsor class: OTHER
First posted: 2006-12-18
Enrollment: 100
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: pregnant outpatients

Brief summary: The purpose of this study is to determine whether insulin resistance might affect the pathogenesis of hypertensive disorders in pregnancy since midtrimester. Furthermore, markers of vascular and placental injuries, of oxidative stress and inflammation will be evaluated.


Eligibility criteria: Inclusion Criteria:

* PCOS, BMI\>/=30
* previous pregnancy affected by hypertension or gestational diabetes
* thrombophilia
* Type I or II diabetes mellitus
* autoimmune diseases
* twin pregnancy
* renal diseases
* previous pre-eclampsia in relatives

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Messina
country: Italy
facility: University Hospital
Study officials:
affiliation: University of Messina
name: Rosario D'Anna, Associate Professor
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT01679730: Changes of Microbiota in Irritable Bowel Syndrome Patients
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Mucosa Associated Bacteria in Small Intestine
Lead sponsor: Far Eastern Memorial Hospital
Sponsor class: OTHER
First posted: 2012-09-06
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Irritable bowel syndrome patients

Brief summary: To investigate the changes of gastrointestinal microbiota in irritable bowel syndrome patients by hydrogen breath test and molecular-based analysis of microbiota in gastrointestinal tract


Eligibility criteria: Inclusion Criteria:

* Case group: 20 to 80 years old irritable bowel syndrome patients
* Control group: 20 to 80 years old healthy subjects

Exclusion Criteria:

* without writtent informed consent
* contraindications for enteroscopy

Primary outcomes:
measure: difference in component of microbiota between cases and controls
Secondary outcomes:
Other outcomes:
Locations:
city: New Taipei City
country: Taiwan
facility: Far Eastern Memorial Hospital
Study officials:
References:
citation: Chung CS, Chang PF, Liao CH, Lee TH, Chen Y, Lee YC, Wu MS, Wang HP, Ni YH. Differences of microbiota in small bowel and faeces between irritable bowel syndrome patients and healthy subjects. Scand J Gastroenterol. 2016;51(4):410-9. doi: 10.3109/00365521.2015.1116107. Epub 2015 Nov 23.
Clinical trial NCT00969930: Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE
Official title: Genetic Association Study Between Single Nucleotide Polymorphisms (SNPs) and Cognitive Performance in Young Bipolar Type I Patients: LICAVALGENE
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bipolar
Keywords: COMT
ApoE
BDNF
executive function
bipolar
cognition
Cognitive deficits and Bipolar disease type I
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2009-09-02
Enrollment: 80
Sex: ALL
Minimum age (years): 18
Maximum age (years): 35
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Young bipolar disease patients in mania, depression, hypomania or mixed states without medication use over the past 15 days.

Brief summary: This is a genetic association study of cognitive impairment in young bipolar disease type I patients without medications in mania, depression, hypomania or mixed states.

Detailed description: Introduction:

Cognitive impairment in bipolar disease (BD) patients is common and recent data suggests that it may be an endophenotype of the disease as it differs individually, persists during periods of euthymia and co segregates in families of BD patients. Cognition is a complex trait and is therefore likely to be underpinned by many genes, each with a relatively small effect. Performance in each domain of the neuropsychological assessment can be statistically linked to the functional activity of particular protein and by extension to the genetic variants accounting for theses functional differences.

Methods:

80 patients with BD type I (SCID DSM-IV), age from 18 to 35 years old, currently on mania, depression, hypomania or mixed state after medication wash out will be submitted to complete neuropsychological evaluation and genotyped for COMT (val158met, rs165599, -287, rs737865), ApoE (epsilon 4) and BDNF (val66met)and 80 healthy controls.

Eligibility criteria: Inclusion Criteria:

* BD type 1
* non euthymia
* 18-35 y.o.

Exclusion Criteria:

* pregnancy
* organic disease
* use of drugs
* schizophrenia
* mental retardation
* illiterate

Primary outcomes:
measure: Cognitive deficits in BD patients are associated with COMT, ApoE and BDNF polymorphisms
timeFrame: 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Sao Paulo
country: Brazil
facility: Institute of Psychiatry, School of Medicine University of Sao Paulo
Study officials:
References:
citation: Soeira-de-Souza MG, Bio DS, Dias VV, Martins do Prado C, Campos RN, Costa LF, Moreno DH, Ojopi EB, Gattaz WF, Moreno RA. SHORT COMMUNICATION: Apolipoprotein E genotype and cognition in bipolar disorder. CNS Neurosci Ther. 2010 Oct;16(5):316-21. doi: 10.1111/j.1755-5949.2010.00153.x.
Clinical trial NCT05405530: Nasal Mask Kit in Gastrointestinal Endoscopy
Official title: Nasal Mask Oxygen Reduces the Incidence of Hypoxia Undergoing Gastrointestinal Endoscopy Under Propofol Sedation: a Multicenter Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Hypoxia
Gastric Cancer
Gastric Polyp
Colon Polyp
Colon Cancer
Esophageal Cancer
Keywords: nasal mask
Hypoxia
Gastrointestinal endoscopy
Propofol
Capnographic Monitoring
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
Collaborators: name: Henan Provincial People's Hospital
name: First Affiliated Hospital of Kunming Medical University
First posted: 2022-06-06
Enrollment: 1204
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Hypoxia is the most common adverse event in gastrointestinal endoscopes sedated with propofol. The nasal mask oxygen kit has good sealing to ensure an adequate oxygen supply and is convenient and economical.The aim of this randomized study was to determine whether the nasal mask oxygen kit reduces the incidence of hypoxia in gastrointestinal endoscopes procedures.


Eligibility criteria: Inclusion Criteria:

* 18≤ Age ≤60
* patients undergoing combined gastroendoscopy and colonoscopy procedure
* patients signed informed consent form
* ASA classification I-II
* Estimated procedure time \<=45min

Exclusion Criteria:

* Coagulation disorders or a tendency of nose bleeding
* Diagnosed heart disease (heart failure, angina, myocardial infarction, arrhythmia, etc.)
* Diagnosed chronic obstructive pulmonary disease or current other acute or chronic lung disease requiring supplemental chronic or intermittent oxygen therapy)
* hypoxia (SpO2\< 90 % )
* Upper respiratory tract infection
* increased intracranial pressure
* Fever (core body temperature \>37.5 ℃)
* Pregnancy, breastfeeding, or positive pregnancy test
* Emergency procedure or surgery
* Multiple trauma
* Allergy to propofol or tape and adhesives
* BMI\<18.5 or BMI\>30

Primary outcomes:
measure: The incidence of hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Secondary outcomes:
measure: The incidence of sub-clinical respiratory depression
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
measure: The incidence of severe hypoxia
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours
measure: The incidence of other adverse events
timeFrame: Patients will be followed for the duration of hospital stay, an expected average about 2 hours]
Other outcomes:
Locations:
city: Zhengzhou
country: China
facility: Henan Provincial People's Hospital
state: Henan
city: Shanghai
country: China
facility: Renji Hospital
state: Shanghai
city: Kunming
country: China
facility: First Affiliated Hospital of Kunming Medical University
state: Yunnan
Study officials:
References:
Clinical trial NCT00855530: Long Term Safety and Tolerability of SR58611 in Patients With Major Depressive Disorder
Official title: A Fifty-Two-Week Multicenter, Open-Label, Study Evaluating the Long-Term Safety and Tolerability of SR58611A 350 mg q12 in Patients With Major Depressive Disorder.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Major Depressive Disorders
Keywords: Depression
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2009-03-04
Enrollment: 527
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Primary objective:

- To evaluate the long-term safety and tolerability of SR58611A (amibegron) patients with major depressive disorder (MDD).

Secondary objective:

- To determine plasma concentrations of SR58878 (the active metabolite of SR58611A), for pharmacokinetic population analyses, to evaluate the quality of life (QoL) in patients with MDD, and to evaluate the efficacy of amibegron in patients with MDD.


Eligibility criteria: Inclusion Criteria:

* patients as defined by Diagnosis and Statistical Manual of Mental Disorders, recurrent episode for at least 1 month prior to entry into the study, and with a total score of \> 18 on the Hamilton Depression Rating Scale (HAM-D) 17-items.

Primary outcomes:
measure: Clinical monitoring of adverse events (AEs), laboratory parameters, vital signs, physical examinations, and physician withdrawal checklists
timeFrame: 54 weeks
Secondary outcomes:
measure: 17-item Hamilton Depression rating Scale, Clinical Global Impression, Sheehan Disability Scale, Qol Enjoyment and satisfaction Questionnaire - Short Form,Medical Outcomes Study Short Form, Endicott Work Productivity Scale.
timeFrame: 54 weeks
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Sanofi-Aventis Administrative Office
city: Santiago
country: Chile
facility: Sanofi-Aventis Administrative Office
city: Athens
country: Greece
facility: Sanofi-Aventis Administrative Office
city: Causeway Bay
country: Hong Kong
facility: Sanofi-Aventis Administrative Office
city: Casablanca
country: Morocco
facility: Sanofi-Aventis Administrative Office
city: Moscow
country: Russian Federation
facility: Sanofi-Aventis Administrative Office
city: Singapore
country: Singapore
facility: Sanofi-Aventis Administrative Office
city: Midrand
country: South Africa
facility: Sanofi-Aventis Administrative Office
city: Barcelona
country: Spain
facility: Sanofi-Aventis Administrative Office
city: Taipei
country: Taiwan
facility: Sanofi-Aventis Administrative Office
city: Megrine
country: Tunisia
facility: Sanofi-Aventis Administrative Office
Study officials:
affiliation: Sanofi
name: ICD CSD
role: STUDY_DIRECTOR
References:
Clinical trial NCT01302548: The Effect Of Wound Irrigation With Irrisept™ Delivery System On Abscess Healing In Patients Presenting To The Emergency Department
Official title: THE EFFECT OF WOUND IRRIGATION WITH IRRISEPT™ Delivery System ON ABSCESS HEALING IN PATIENTS PRESENTING TO THE EMERGENCY DEPARTMENT
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Abscess
Keywords: Abscess
Wound Irrigation
Wound Debridement
Wound Healing
Incision and drainage
Chlorhexidine
Lead sponsor: University of Florida
Sponsor class: OTHER
Collaborators: name: Irrimax Corporation
First posted: 2011-02-24
Enrollment: 33
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to determine if wound cleansing and irrigation using the IRRISEPT Chlorhexidine Gluconate(CHG)solution, applying a given volume with a pressurized stream, will improve the outcome for infected abscesses in patients that present in the emergency department.


Eligibility criteria: Inclusion Criteria:

* Immunocompetent individuals 12 years of age or older with an uncomplicated abscess
* Patient must be able to answer questions and be medically stable as defined by the Emergency Department physician
* Patient must voluntarily participate in the study

Exclusion Criteria:Patients with any of the following are excluded:

* Currently receiving antibiotics or received antibiotics within last 72 hours
* Evidence of systemic infection (fever, aches, chills, nausea)
* Requires admission to the hospital for infection or for any other reason(s)
* Abscess caused by a human or animal bite
* Prior history of hypersensitivity or allergy to Chlorhexidine Gluconate (CHG)
* Immunodeficiency (Examples: HIV Positive, Crohns Disease, Systemic Lupus Erythematosus, Addison's disease, psoriasis, splenectomy, leukemia, cancer on chemotherapy)
* Currently on any immune-modifying medication (Examples: prednisone, antivirals)
* History of chronic skin infection (3 or more in the past year)
* Chronic medical problem, for example end-stage heart, liver, kidney, or lung disease, diabetes mellitus, peripheral vascular disease, history of organ transplant
* Mental illness including but not limited to substance abuse, dementia, schizophrenia or mentally handicapped or challenged
* Incarcerated
* Patient is pregnant or thinks she may be pregnant

Primary outcomes:
measure: Abscess Healing Based on Abscess Measurement Scale
timeFrame: 48 hours
Secondary outcomes:
measure: Number of Patients Prescribed Oral Antibiotics
timeFrame: 48 hours
measure: Abscess Measurement Using a Abscess Measurement Scale in Methicillin-resistant Staphylococcus Aureus (MRSA) Positive Patients.
timeFrame: 48 hours
Other outcomes:
Locations:
city: Gainesville
country: United States
facility: Shands Hospital at the University of Florida
state: Florida
Study officials:
affiliation: University of Florida
name: Richard F Petrik, MD
role: PRINCIPAL_INVESTIGATOR
References: