louisbrulenaudet/clinical-trials huggingface dataset:
Clinical trial NCT04322461: Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population
Official title: Effect of Exercise, Endocannabinoids and Ketones on Cerebral Metabolism in a Cognitive Disorders Population : Pilot Project PARKA
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Parkinson Disease
Alzheimer Disease
Keywords: Alzheimer
Parkinson
Ketones
medium chain triglycerides
cognition
brain
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Société des Produits Nestlé (SPN)
First posted: 2020-03-26
Enrollment: 14
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: A two months intervention in which two groups of cognitive disorders, Parkinson and Alzheimer's disease, will receive 50g/day of a commercial MCT supplement combined with supervised aerobic exercise 3 times/week. Cognition and ketones will be assess before and after the intervention, along with endocannabinoids plasma concentrations.


Eligibility criteria: Inclusion Criteria:

* Alzheimer's or parkinson disease diagnostic
* Stable medication associated with the disease
* Able to consent
* Presence of an accompanying person for the first and last visit.
* Ability to read and talk in French

Exclusion Criteria:

* MMSE \< 20
* MCT or coconut oil supplementation
* Coconut allergy
* Cannabis, THC or CBD consumption
* Excessive alcohol consumption
* Physical activity 3x/week
* Presence of an metallic object in the body
* Impossibility to lay in dorsal decubitus for 40 minutes
* Cardiac disease
* Any uncontrolled disease that could interfer with the project.

Primary outcomes:
measure: Cognition
timeFrame: 2 months, evaluation before and after intervention
measure: Ketones
timeFrame: 2 months, evaluation before and after intervention
Secondary outcomes:
measure: Endocannabinoids
timeFrame: 2 months, evaluation before and after intervention
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Centre de recherche sur le vieillissement
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Stephen Cunnane, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT06909461: The Effect of Pain Neuroscience Education
Official title: The Effect of Pain Neuroscience Education on Physiotherapy Students' Knowledge, Attitudes and Behaviours Towards Pain: A Single-blinded Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Student Education
Lead sponsor: Celal Bayar University
Sponsor class: OTHER
First posted: 2025-04-03
Enrollment: 52
Sex: ALL
Minimum age (years): 18
Maximum age (years): 22
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A single-blinded randomized controlled trial
Primary purpose: OTHER

Brief summary: The aim of this study is to examine the effect of pain neuroscience education (PNE) on physiotherapy students' knowledge, attitudes and behaviors towards pain. A total of 52 physiotherapy students will be included in the study. Students will be randomly randomly assigned to either PNE group (n=26) or control group (CG) (n=26). The PNE group will be receive a 70-min PNE based on the explanations used in "Explain Pain". The CG group will be received an education about red-flags which are special screening questions for serious pathology. The red-flags education will be discussed tissue pathology and Waddell's triage for back pain classification.Neurophysiology and the biopsychosocial model will not be discussed. Before, immediately after, and 2-months after the education sessions all students will be completed four questionnaires, the Revised Neurophysiology Pain Questionnaire (RNP-Q), the Health Care Providers' Pain and Impairment Relationship Scale(HC-PAIRS), and the red-flags questionnaire.


Eligibility criteria: Inclusion Criteria:

* volunteer to participate in study
* to studying in physiotherapy
* be able to read and understand Turkish

Exclusion Criteria:

- having received pain neuroscience education

Primary outcomes:
measure: Pain neurophysiology knowledge
timeFrame: an hour
Secondary outcomes:
measure: Attitudes and behaviours
timeFrame: an hour
Other outcomes:
Locations:
city: Mani̇sa
country: Turkey
facility: Manisa Celal Bayar University
Study officials:
References:
Clinical trial NCT01910961: Impact of Limb Remote Ischemic Preconditioning on Mortality and Quality of Life During Abdominal Aortic Aneurysm Repair
Official title: Impact of Limb Remote Ischemic Preconditioning on Mortality, Hospitalization Costs and Quality of Life During Elective Abdominal Aortic Aneurysm Repair: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Abdominal Aortic Aneurysm
Lead sponsor: First Affiliated Hospital, Sun Yat-Sen University
Sponsor class: OTHER
Collaborators: name: Huazhong University of Science and Technology
name: West China Hospital
First posted: 2013-07-30
Enrollment: 360
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: To investigate the influence of limb remote ischemic preconditioning (LRIP) on mortality, hospitalization costs and quality of life in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.

Detailed description: Remote ischaemic preconditioning may confer the cytoprotection in critical organs. The investigators have revealed that limb remote ischemic preconditioning (RIPC) would reduce intestinal and pulmonary injury in patients undergoing open infrarenal abdominal aortic aneurysm (AAA) repair.Few groups have investigated the long term influence of limb remote ischemic preconditioning.Therefore, the investigators evaluated the impact of limb remote ischemic preconditioning on mortality, hospitalization costs and quality of life during elective abdominal aortic aneurysm repair in a prospective, randomized, controlled, single blind setting.

Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of abdominal aortic aneurysm
* Must be received open abdominal aortic aneurysm repair

Exclusion Criteria:

* age \>80 years old
* Acute coronary syndrome or myocardial infraction within 3 months
* Chronic obstructive pulmonary emphysema
* angina pain within 48 hours of repair procedure
* ejection fraction less than 40%
* poor pulmonary function (PaO2 \<60mmHg)

Primary outcomes:
measure: all cause mortality
timeFrame: one year
Secondary outcomes:
measure: hospitalization costs
timeFrame: 30 days after operation
Other outcomes:
Locations:
Study officials:
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Kexuan Liu, PhD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT05370261: Pharmacological Profile of Different Berberine Formulations, and Effects on Blood Sugar Levels
Official title: Comparing the Pharmacological Profile of Different Berberine Formulations, and Their Effects on Blood Sugar Levels
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pharmacokinetics
Keywords: Bioavailability
Berberine
LipoMicel
Pharmacokinetics
Lead sponsor: Factors Group of Nutritional Companies Inc.
Sponsor class: INDUSTRY
First posted: 2022-05-11
Enrollment: 12
Sex: ALL
Minimum age (years): 21
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: The primary objective of this study is to evaluate the gastrointestinal absorption of berberine (hydrochloride) in a novel formulation in healthy adult volunteers by comparing it with free berberine (hydrochloride) formulation. Several pharmacokinetic parameters are compared.

As secondary objective, the immediate or short-term effects of Berberine supplementation on blood sugar levels in healthy volunteers are evaluated via a glucose tolerance test (OGTT) using a portable glucometer.


Eligibility criteria: Inclusion Criteria:

* Age 21-65
* healthy, good physical condition

Exclusion Criteria:

* Pregnancy or breast-feeding
* Gastrointestinal conditions
* Acute or chronic liver disease
* Acute or chronic kidney disease
* Acute or chronic cardiovascular disease
* Hematological disease
* Diabetes
* Allergy or Intolerance to gluten
* Allergy or Intolerance to Berberine
* Use of any form of nicotine or tobacco
* Alcohol and substance abuse history
* Use of medications (e.g., blood sugar-lowering agents, or statins)
* Use of Berberine supplements
* Participation in another investigational study

Primary outcomes:
measure: AUC: the area under the concentration-time curve
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
measure: Cmax: maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
measure: Tmax: the time point of maximum plasma concentration
timeFrame: 0 (baseline; pre-dose), 0.5, 1, 2, 3, 4, 6, 8, 10, 12, 24 hours (post-dose)
Secondary outcomes:
measure: Effects on Blood sugar levels
timeFrame: 0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)
measure: Changes in Blood sugar concentrations
timeFrame: 0 (Baseline; pre-dose), 0.5, 1, 2, 3, and 4 hours (post-dose)
Other outcomes:
Locations:
city: Burnaby
country: Canada
facility: ISURA
state: British Columbia
Study officials:
References:
Clinical trial NCT05886361: Somatic Symptoms in Autism Spectrum Disorder: Data Integration
Official title: Somatic Symptoms in Autism Spectrum Disorder: Data Integration
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Autism Spectrum Disorder
Somatic Symptom Disorder
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2023-06-02
Enrollment: 1423
Sex: ALL
Minimum age (years): 15
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: as mentioned earlier, it is a retrospective study with existed data. Therefore, the 1423 participants are already collected in the past. We separate these existed data into three groups as mentioned in the eligibility criteria

Brief summary: Autistic patients have higher chances commorbid somatic symptoms. Therefore, it leads to more health-related concerns, such as autoimmune disease, gastrointestinal disease, cardiovascular disease, autonomic disorders. On average, autistic patient's life span is 16 years shorter than non-autistic patients. Furthermore, autistic patients are not able to convey or communicate their somatic symptoms in a clear and comprehensive manner. This leads to unable to receive proper health care in a timely manner.


Eligibility criteria: Inclusion Criteria:

* ASD group: diagnosed with DSM-5 autism spectrum disorder
* clinical group: anxiety, depression, somatic disorder who are non-psychotic and non-organic
* control group: healthy control without psychiatric disorder or chronic somatic symptoms
* age between 15 and 70

Exclusion Criteria:

* psychiatric disorders such as schezophrenia, mood disorder.
* major physical disorder which can be potentially lethal
* who cannot read or comprehend the survey and questionnaire

Primary outcomes:
measure: Patient health questionnaire-15, PHQ-15
timeFrame: 8 years
measure: Health assessment questionnairse, HAQ
timeFrame: 8 years
measure: Beck depression inventory, BDI
timeFrame: 8 years
measure: Beck anxiety inventory
timeFrame: 8 years
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT00171561: Valsartan/Hydrochlorothiazide Combination vs Amlodipine in Patients With Hypertension, Diabetes, and Albuminuria.
Official title: A 24-week Study to Evaluate the Effectiveness of Valsartan in Combination With Hydrochlorothiazide Versus Amlodipine on Arterial Compliance in Patients With Hypertension, Type 2 Diabetes and Albuminuria
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Hypertension
Keywords: hypertension
diabetes
albuminuria
valsartan
hydrochlorothiazide
amlodipine
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 144
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is assess if treatment with valsartan and a diuretic, hydrochlorothiazide, has beneficial effects in people with high blood pressure, diabetes, and albuminuria (protein in the urine) compared with amlodipine. In particular, the study will assess whether the treatment will decrease the stiffness of the blood vessels.


Eligibility criteria: Inclusion Criteria:

* type 2 diabetes
* elevated blood pressure and pulse pressure
* albuminuria

Exclusion Criteria:

* Severe hypertension
* History of stroke, myocardial infarction, heart failure, chest pain, abnormal heart rhythm
* Liver, kidney (not caused by diabetes), or pancreas disease
* Type 1 diabetes or uncontrolled type 2 diabetes
* Allergy to certain medications used to treat high blood pressure

Other protocol-defined inclusion/exclusion criteria may apply.

Primary outcomes:
measure: Blood measures of hypertension after 24 weeks
Secondary outcomes:
measure: Blood measures of hypertension in arterial system after 24 weeks
measure: Change in protein excretion rate after 24 weeks
measure: Change in serum markers of endothelial function and oxidative stress after 24 weeks
Other outcomes:
Locations:
city: Basel
country: Switzerland
facility: Novartis Pharmaceuticals
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Karalliedde J, Maltese G, Hill B, Viberti G, Gnudi L. Effect of renin-angiotensin system blockade on soluble Klotho in patients with type 2 diabetes, systolic hypertension, and albuminuria. Clin J Am Soc Nephrol. 2013 Nov;8(11):1899-905. doi: 10.2215/CJN.02700313. Epub 2013 Aug 8.
Clinical trial NCT03645161: Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts
Official title: Comparison Between Local and Imported Skin Prick Testing Result of Rat and Mouse Allergen Extracts in Respiratory Allergy Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Allergic Rhinitis Due to Animal Hair and Dander
Lead sponsor: Mahidol University
Sponsor class: OTHER
First posted: 2018-08-24
Enrollment: 230
Sex: ALL
Minimum age (years): 3
Maximum age (years): 60
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

Brief summary: In respiratory allergy patients, skin prick test results of local rat and mouse allergen extracts are not significant different from imported ones

Detailed description: Many researches proposed that rodent deteriorate symptoms in patients with respiratory allergy who sensitized. The test that can identify rodent sensitization will be very useful. The investigators found lots of problems from imported mouse and rat allergen extract, eg. expensive cost and hard to find importing agency in Thailand. Making own local allergen extract will be the good solution for the country. This study aim to compare the results of locally rat and mouse allergen to imported ones.

Eligibility criteria: Inclusion Criteria:

* Patients age 3 to 60 years old who diagnosed with asthma or allergic rhinitis
* Patient must not take these following medication at least 7 days before doing the skin prick test: antihistamine, oral corticosteroid (more than 20 mg/day of prednisolone), topical steroid that was apply on skin test area.

Exclusion Criteria:

* Pateints who have other chronic underlying disease e.g. obesity, heart disease and liver disease
* Patient with allergic asthma who is still uncontrollable.
* Patient with active severe atopic dermatitis
* Patient who are pregnant or in lactating period
* Patient or parent deny to join in the study

Primary outcomes:
measure: Comparison between local and imported skin prick testing result of rat and mouse allergen extracts in respiratory allergy patients
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Bangkok
country: Thailand
facility: Siriraj Hospital. Mahidol University
Study officials:
affiliation: Department of Pediatrics, Siriraj hospital, Mahidol University
name: Nualanong Visitsunthorn, MD
role: PRINCIPAL_INVESTIGATOR
References:
Clinical trial NCT03782961: Evaluation of Viscosity of a Vaginal Moisturizer
Official title: Evaluation of Perceived Effectiveness to Evaluate Viscosity of a Vaginal Moisturizer in Menopaused Women
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Vaginal Dryness
Menopausal Women
Lead sponsor: Farmoquimica S.A.
Sponsor class: INDUSTRY
First posted: 2018-12-20
Enrollment: 33
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: To evaluate the perception of viscosity of a vaginal moisturizer in postmenopausal women

Detailed description: A unicentric, blind, non-comparative clinical study to prove the perceived efficacy of the research product.

It will be necessary 33 female research participants, aged between 45 and 70 years menopause with complaint of vaginal dryness.

The participant will remain in the study for one day, making use of the research product in the Research Center.

Participants will be divided into 2 groups so that each group observes the viscosity (flow) of the test product in a different anatomical position (lying down and standing) immediately after application of the product, after 15 and 30 minutes.

Participants will respond to a subjective assessment using a standardized questionnaire to capture possible feelings of discomfort during the study.

A gynecologist will be available to monitor the participants throughout the study.

Eligibility criteria: Inclusion Criteria:

* Menopausal participants for at least 6 months;
* Participants with complaints of vaginal dryness;
* Skin integrity in the region of product analysis;
* Agreement to comply the procedures of the trial and attend the clinic on the days and times determined for applications and / or evaluations;
* Understanding, agreement and signing of the Informed Consent Term.

Exclusion Criteria:

* Use of anti-inflammatory / immunosuppressive / antihistamine drugs up to 3 weeks prior to selection;
* Pathologies and / or active skin lesions (local and / or disseminated) in the evaluation area;
* Immunosuppression by drugs or active diseases;
* Decompensated endocrinopathies;
* Relevant clinical history or current evidence of alcohol or other drug abuse;
* known history or suspected intolerance to products of the same category;
* Intense sun exposure up to 15 days before evaluation;
* Gynecological treatment up to 4 weeks before evaluation;
* Other conditions considered by the researcher to be reasonable for disqualification of study participation.

Primary outcomes:
measure: To evaluate subjectively the perceived viscosity change
timeFrame: Immediately after application, 15 and 30 minutes after application
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
Clinical trial NCT03521661: Efficacy of Kyphoplasty With a New Intervertebral Expander
Official title: Efficacy of Kyphoplasty With an Intravertebral Expander for Correction of Spine Deformity After Osteoporotic Vertebral Fracture
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Vertebral Body Compression
Keywords: Vertebral fracture
Kyphotic deformity
Kyphoplasty
Vertebroplasty
Lead sponsor: Johann Wolfgang Goethe University Hospital
Sponsor class: OTHER
First posted: 2018-05-11
Enrollment: 41
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 new osteoporotic vertebral body fractures who were eligible for kyphoplasty and were treated with kyphoplasty, were observed prospectively 12 months after the surgery. In the follow-up period the clinical and radiological data were collected

Brief summary: Balloon kyphoplasty is a well-established treatment option to achieve pain relief and to correct kyphotic deformity caused by osteoporotic vertebral compression fracture. However, it has been demonstrated that reduction is partly lost as balloon is deflated in the vertebral body. An intravertebral expander was developed for better reduction and maintenance of vertebral body height while cement is injected. This study evaluates the efficacy of kyphoplasty with a new intravertebral expander with regard to correction of kyphosis angel and to restoration of vertebral body height.


Eligibility criteria: Inclusion Criteria:

* Osteoporotic vertebral body fractures that were classified as A1 fractures according to Arbeitsgemeinschaft Osteosynthesis (AO) Classification

Exclusion Criteria:

* More than 2 vertebral body fractures
* Fractures of vertebral body based on malignancy
* Previous spinal operation
* Spinal infection
* Spinal deformity (scoliosis)

Primary outcomes:
measure: Radiological evaluation
timeFrame: 12 months
Secondary outcomes:
measure: Visual Analogue Scale
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
affiliation: Goethe University
name: Mohammad Arab Motlagh, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: