cyrilzakka/clinical-trials huggingface dataset:
Study on Adherence to a Mediterranean Diet in a Population of Patients With Type 2 Diabetes

In randomized clinical studies, the mediterranean diet has demonstrated beneficial effects on glucose and lipids levels, on body composition, on waist to hip ratio, especially in patients with type 2 diabetes. Consequently, the meditteranean diet is now recommended by experts in cardiology, nutrition and diabetology. However, many of these publications have been generated in populations living around the Mediterranean Basin. Thus, it is not sure that this diet can be used by people living outside this geographic area. We aimed to study the capacity of consecutive patients admitted in diabetology to follow the mediterranean diet recommandations during 12 months. The adherence will be studied in the real life in order to identify all limitations to follow this diet. Therefore, this study may help to find solutions to reinforce adherence to this diet.

Patients older than 18 years of age and consequently admitted in the Dpt of Diabetology in the Pitié-Salpêtrière and the Georges Pompidou Euopean Hospitals will be enroled in this study. After a survey of eating habits, the 14 items of the mediterranean diet (accordingly to Schröder H et al., J Nutr 2011) will be explained. Adherence to the diet is defined by the achievement of more than 9 items from the original list of 14 items. Adhesion to the diet will be studied à 3 and 12 months by questionnaires and the analysis of olive oil consumption (urine levels of hydroxytyrosol and alpha linoleic acid levels in bloood). Consequences of adhesion to the diet on body weight, body composition, glucose and lipids levels, HbA1c and liver enzymes in blood will be collected at 3 and 12 months. At the end of the study, patients will complete a semi-quantitative questionnaire with a sociologist in order to identify main limitations to achieve items of the diet.

Eligibility Criteria:
Inclusion Criteria:

* Patient over 18 years old.
* Patient with type 2 diabetes regardless of the hypoglycaemic treatments used and their HbA1c level.
* Patient referred to the Diabetology day hospital of the CHU Pitié-Salpêtrière and Nutrition of the HEGP for assessment of diabetes and/or for obesity assessment and dietary education as part of routine care.
* Patient accepting the constraints of the protocol after explanation of it and not opposing to participate in it.
* Patient benefiting from or entitled to health insurance coverage outside of the AME.

Exclusion Criteria:

* Patient with current or recent infections (\<10 days).
* Patient with unstable neoplastic (with the exception of carcinoma in situ of the cervix or cutaneous epithelioma), hematological, psychiatric (with the exception of eating disorders (ED)).
* Pregnant or breastfeeding patient.
* Person under legal protection.
Impact of Treatment Induced Premature Menopause on Quality of Life

To understand the impact of treatment induced menopause on quality of life and sexuality following blood and marrow transplantation.


Eligibility Criteria:
Inclusion Criteria:

* premenopausal
* sexually active women
* able to read and write English

Exclusion Criteria:

- postmenopausal females
Paradoxical Lucidity in Severe End-Stage Dementia

Cognitive decline in dementia is considered irreversible, however episodes of paradoxical lucidity (PL) in severe dementia suggest other mechanisms may be in play. Beyond anecdotal reports of transient PL events occurring in patients predominantly in late-stage dementia and typically lasting anywhere from a few minutes to several hours, little is known about PL. The study team proposes to develop and conduct a mixed methods prospective study of PL during end stage advanced dementia, creating a definition and measurement scale for PL in advanced dementia, and identifying the potential electro cortical biomarkers of PL in advanced dementia. This study will be divided in two phases: Phase I and Phase II. During Phase I, the study team will collect sufficient and necessary data through an online survey and focus groups as well as assess the safety and feasibility of using symptom diaries (also known as daily trackers or journals) and real-time video EEG monitoring (vEEG). After preliminary review of the study procedures, the PI will decide whether to move onto the Phase II. The second phase will aim to expand the study population and refine study methods as well as create a definition and measurement scale for PL in advances dementia.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Advanced (severe) dementia diagnosed using the Global Deterioration Scale (GDS) with a score of 7 or the Palliative Performance Scale (PPS) with a score of less than 30%
* Accepted for hospice care based on the Medicare eligibility guidelines
* No longer being provided with nutrition or fluids
* Anuria (dry diaper) or less than 200cc urine (almost dry diaper) in any 24-hour period

Exclusion Criteria:

* Cognitive or functional impairment due to a diagnosis other than dementia
* Dementia with a GDS score \<7 (mild, moderate, moderately severe dementia). Please refer to rationale outlined for inclusion criteria 2.
Early Detection of Atherosclerosis: a Randomized Trial in the Primary Prevention of Cardiovascular Diseases.

The incidence of cardiovascular diseases is still high and further efforts should be done in primary prevention. The main objective is to quantify the burden of subclinical atherosclerosis using non-invasive techniques,and to study the impact of this assessment and consequent treatment in the progression of atherosclerosis and in the incidence of cardiovascular diseases.

We will perform non-invasive techniques (carotid Intima-Media Thickness, CAC score and ankle-brachial index) to individuals at intermediate cardiovascular risk.With these results, we will classify participants in: no atherosclerosis, mild, moderate and severe atherosclerosis, and therapeutic targets will be set according to pre-defined algorithms. The end-point will be the course of atherosclerosis measured by cIMT/CAC score (2 years) and the incidence of CVD at 5 years of follow-up.

Eligibility Criteria:
Inclusion Criteria

One or more of the following:

* Familiar History of early-onset cardiovascular disease (male \< 55 or female \< 65).
* Type 2 Diabetes mellitus or type 1 with microalbuminuria.
* Essential High Blood Pressure.
* Chronic Kidney Disease.
* Primary hyperlipidemia.

The presence of two or more of the following:

* Current smoker.
* Physical inactivity.
* High blood pressure (recently diagnosed).
* Abdominal perimeter: \> 102 cm. males; \> 88 cm. females.
* Total cholesterol \> 240 mg/dL.
* HDL cholesterol ≤ 40 mg/dL males, ≤ 50 mg/dL females.

Exclusion Criteria:

* Age \< 40 or \> 74 years old.
* Previous Cardiovascular Event.
TRE: Microbiome, Metabolic Health and Bone

In the Time-Restricted Eating: Microbiome and Bone (TREMBO) study, the primary goal is to determine the effect of time-restricted eating with caloric restriction compared to caloric restriction alone on body weight, the gut microbiota, and bone health in older women who are overweight or obese.

Time-restricted eating (TRE) has gained increased attention due to the possibility to induce weight loss and improve cardiometabolic health as a result of the purported alignment of circadian rhythm. However, since TRE is often reported to cause a spontaneous reduction of calories, it is not well understood if these health benefits are due to weight loss, circadian rhythm alignment, or a combination of the two. Furthermore, while weight loss can improve cardiometabolic health, it can also induce bone loss, which is problematic in older women who are at a higher risk of fracture. Interestingly, both bone turnover and the gut microbiota are responsive to diurnal variations, such as meal timing, and alterations in the gut microbiota have been associated with differences in bone health. In rodent models, caloric restriction can alter the gut microbiota composition with further alterations shown due to time-restricted eating. This suggests that time-restricted eating could affect bone health, which may be partially mediated by changes in the gut microbiota. Also, lifestyle patterns affects both the microbiota and bone. This randomized controlled trial will use behavior modification to examine TRE plus caloric restriction (CR) to achieve an evening energy deficit compared to CR alone on body weight, the gut microbiota, and bone health in older women who are overweight or obese.

Eligibility Criteria:
Inclusion Criteria:

* Postmenopausal women (\>2 years since last menses)
* Body mass index (25-45 kg/m2)
* Agree to be randomly assigned to consume food for ≤ 9 hours/day or ≥12 hours/day
* Must attend on-site visits (about 10) in New Brunswick, NJ, USA (transportation/reimbursement for travel not included)

Exclusion Criteria:

* Participants with \>5% weight loss in the past 6 months or extreme dietary/physical activity habits
* An inability to follow the experimental intervention or to perform the required specimen collections
* Antibiotic use in the past 2 months
* Current diagnosis, or history of cancer in past 3 years
* History of surgical procedure for weight loss in the past 3 years
* Current diagnosis or history of bone diseases, type I or II diabetes, gastrointestinal disease, hyperparathyroidism, untreated thyroid disease, significant immune, hepatic, cardiac, or renal disease
* Uncontrolled hypertension or hyperlipidemia in abnormal ranges
* Regular use of medications that affect bone metabolism, including bisphosphonates or hormone replacement.
* A colonoscopy within the past 2 months
* Alcohol or illicit drug abuse
* Current smoker or having quit smoking in the past 3 months
* Shift work
* Participation in another clinical research trial which may interfere with the results of this study.
Relationship Between Electrical Pain Tolerance Threshold of Alveolar Ridge and Individual Attributes

This study was conducted with an aim to know how individual attributes associated to intraoral Pain Tolerance Threshold. The hypotheses were that the Pain Tolerance Threshold associated to age, sex, prosthodontic oral condition evaluated by the Eichner Index, and psychological state evaluated by the Profile of Mood States.


Eligibility Criteria:
Inclusion Criteria:

* not pacemaker wearers

Exclusion Criteria:

* general health problems that could affect the measurement of nerve activity a lack of understanding of written or spoken Japanese
Hydronephrosis ARFI Study

Pediatric upper urinary tract dilatation (hydronephrosis) is relatively common and may be either obstructive or nonobstructive. While the upper urinary tract is commonly evaluated by ultrasound, this imaging technique often fails to distinguish obstructed from nonobstructed systems. ARFI SVI is a new ultrasound technology that can be used to determine stiffness by measuring a tissue's shear wave velocity, may show alterations in parenchymal shear wave velocity in kidneys that show obstruction on DRS (Diuretic renal scintigraphy)which serves as the reference standard.


Eligibility Criteria:
Inclusion Criteria:

1. 18 years of age or younger
2. You are scheduled for diuretic scintigraphy (DRS)testing -

Exclusion Criteria:

None

-
Complications After Lumpectomy, Sentinel Node and Radiotherapy in Breast Cancer Patients and Physiotherapy Care

To make an inventory of the physiotherapeutic care and the post-operative complications of patients who have undergone lumpectomy, sentinel node and radiotherapy treatment.

The investigators expect to see a lack of consultation of physiotherapists by patients despite a significant number of complications, impacting the quality of life.

This study is observational and descriptive. For this purpose, patients meeting the inclusion and non-inclusion criteria can answer, if they wish, to an online questionnaire after having read the information and non-opposition letter.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer Patients
* Patients with a good command of French in order to understand the letter of information and the questionnaire.
* Patients treated at the "Couple Enfant Hospital" in Grenoble. We have chosen to take patients who have been operated on at least 3 months ago (average time of end of radiotherapy).

Exclusion Criteria:

* Patient having undergone a mastectomy or chemotherapy
* Patient with difficulties understanding, expressing or reading the French language
* Vulnerable patient or patient with impaired cognitive capacities (dementia, confusion)
* Patient subject to a legal protection measure or out of state to express her opposition (guardianship, curatorship)
TA-65 and Aging Associated Microvascular Dysfunction

The goal of this clinical trial is to test whether activation of telomerase with a dietary supplement (TA-65) improves microvascular function.

The purpose of this clinical trial is to examine whether activation of autophagy with TA-65 which activates telomerase, improves microvascular function and blood pressure in an older population

Eligibility Criteria:
Inclusion Criteria:

* Healthy Adults 18 - 35 and 65+ years of age
* Subjects with clinical diagnosis of CAD

Exclusion criteria will include:

* 36-64 years of age without clinical diagnosis of CAD
* Self-reported habitual vigorous exercise (\>20 min, 3 times per week, 1 yr)
* Major Adverse Cardiovascular Event (MACE) in the last year (heart attack, stroke)
* Heart Failure
* Renal Impairment
* \>3 Pre-existing Cardiovascular Risk Factors (healthy groups only)
* Type 1 or type 2 diabetes
* Uncontrolled hypertension
* Current tobacco use or within last 6 months
* BMI \> 35
* Hyperlipidemia
* Hypercholesterolemia
* Use of anti-coagulant drugs
* Use of anti-platelet drugs
* Erectile dysfunction medication in the past 6 months
* Use of topical/non-topical steroids in last 6 months
* Hormone replacement therapy (Post-Menopause or Gender Reassignment)
* History of retinopathy
* Documented neuromuscular disorders
* Porphyria Cutanea Tarda (blistering of skin to sun; photosensitivity)
* Pregnancy (young female subjects)
* Allergy to lidocaine
* Current diagnosis of cancer with or without active anti-cancer treatment (pharmaceuticals) or treatment within last 12 months
* Active COVID-19 or within the past 3 months
Neuroimaging Study on the Effect of Transdermal Buprenorphine in Complex Regional Pain Syndrome Patients

In the present study, we aim to investigate the effect of buprenorphine on neuroinflammation in patients with complex regional pain syndrome, using \[11C\]-(R)-PK11195 PET.


Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with complex regional pain syndrome Type I (Budapest Criteria) and persistent back pain (VAS ≥ 4).
2. Patients who can stop benzodiazepine treatment 2 weeks before study
3. Patients who initially decided to use buprenorphine according to clinical judgment
4. Patients who are able to understand the purpose and procedure of the study

Exclusion Criteria:

1. Patients with an impaired cognitive function such as psychosis, dementia, or mental retardation
2. Patients with neurologic disease, cerebrovascular disease, history of brain tumor, history of severe head trauma, history of convulsive disease
3. Patients with cardiovascular disease, liver, respiratory or renal dysfunction
4. Patients with biliary disease
5. Patients who could not undergo the PET/magnetic resonance imaging (MRI) process.
6. Patients who have a risk of suicide or show aggressive behavior
7. Patients who have drug dependence (DSM-IV criteria) or history (past 6 months or older)
8. Employees of researchers or clinical research institutes
9. Patients with hypersensitivity or contraindication to buprenorphine
Effectiveness of Virtual Reality on Functional Mobility During Treadmill Training in Children With Cerebral Palsy

Cerebral palsy (CP), which occurs as a consequence of brain damage, has multiple deficits such as a global reduction of motor cortical activity during movement execution and inadequate processing of corticospinal and somatosensory circuits. Global registers estimate that it occurs in two to three of 1.000 live births, and spasticity is the most common disorder, occurring in 80% of children with CP. Spasticity might affect both upper and lower limbs, resulting in other deficits in joint mobility, postural reactions, selective motor control, balance, and gait. This set of impairments and deficits may lead to limitations in functional ability and autonomy in the performance of daily living activities, physical fitness, quality of life, and/or ability to participate in games and sports activities compared to neurotypical peers of the same age.

Walking is considered one of the most important activities in daily life, as it is essential for activities of daily living and social participation. Children with Gross Motor Function Classification System (GMFCS) levels I, II, and III show potential for walking, and around 75% of CP children are ambulatory. However, abnormalities in neural control and muscle weakness contribute to several gait characteristics such as slow velocity, decreased stride length, increased stance phase percentage, and increased peak ankle dorsiflexion and knee flexion, and peak hip extension moments. Consequently, this gait pattern contributes to postural instability and increased fall risk in children with CP, among others.

The main objective of the present study is to evaluate the effectiveness of treadmill gait training and virtual reality comparing to treadmill gait training on functional mobility in infants with spastic cerebral palsy.

The study design is a two-arm randomized clinical trial, single-center and single-blind (evaluators). The sample will be recruited at the Hospital General de Vic, and the study will be conducted at the Universitat de Vic - Universitat Central de Catalunya (UVic-UCC).

Eligibility Criteria:
Inclusion Criteria:

* Medical diagnosis of spastic cerebral palsy
* Motor function levels I to III according to the Gross Motor Function Classification System
* Independent walking was acquired for more than 12 months.
* Able to ambulate for at least 10 meters with or without aids.

Exclusion Criteria:

* Orthopaedic surgery on the lower limbs in the past 12 months.
* Scheduled surgery during the period of the study.
* Orthopaedic deformities with surgery indication.
* Uncontrolled seizure disorder.
* Metallic implant in the skull.
* Hearing aid.
* Have received toxic botulin injections in the past 6 months.
* Significant cognitive or visual impairment.
Therapeutic Strategy Associated With bDMARDs or tsDMARDs in Rheumatoid Arthritis and Psoriatic Arthritis

This is a longitudinal, observational, prospective, multicentre study conducted in France, among a representative sample of rheumatology doctors.

The aim of this study is to describe in real life the therapeutic strategy when faced with a patient with rheumatoid arthritis (RA) or psoriatic arthritis (PsA) who requires initiation of treatment with biotherapy or targeted therapy. The evolution of the disease and the possible therapeutic adaptations will then be followed for 2 years.


Eligibility Criteria:
Inclusion Criteria:

* Major patient (age ≥ 18 years)
* Patient with RA according to American College of Rheumatology (ACR) / European Congress of Rheumatology (EULAR) 2010 or ACR 1987 or patient with PsA according to ClASsification criteria for Psoriatic ARthritis (CASPAR) criteria
* Patient undergoing treatment with methotrexate (MTX) (oral or injectable) initiated for at least 3 months.
* Naïve patient of biotherapy or tsDMARD and requiring the introduction of a first bDMARD or tsDMARD due to the activity of the disease.
* Patient informed and accepting the computer processing of his/her medical data and informed of his/her rights of access and rectification.

Exclusion Criteria:

* Patient participating in an interventional study in rheumatology
* Patient with axial spondyloarthritis (for patients with PsA)
Response of Metabolic Syndrome and Sexual Dysfunction to Lifestyle Changes in Men With Psoriasis

complaint of sexual dysfunction and metabolic syndrome are highly reported in men with psoriasis

erectile dysfunction (ED) psoriatic men with metabolic syndrome (number of the patients will be 60) will assigned to study group (group = 30 patients) that will receive lifestyle changes (12 weeks of low calorie diet and moderate-intensity walking on treadmill, the walking duration will be 40 minutes, the walking will be three times per week) or control group (group=30 patients) that will receive no lifestyle changes/modifications.

Eligibility Criteria:
Inclusion Criteria:

* psoriatic married men with metabolic syndrome and erectile dysfunction

Exclusion Criteria:

* patients with heart, respiratory, other autoimmune problems
Celiac Disease in Childhood-Adulthood Transition

Aims of this study are to evaluate adolescents with celiac disease during their transition from pediatrics to adult care, and to develop better healthcare follow-up practices.

Celiac disease is one of the most common chronic gastrointestinal diseases affecting 1-3% of population worldwide. It is treated with life-long and strict gluten-free diet. When dietary treatment is successful, prognosis of pediatric patients seems to be excellent whereas ongoing predisposition to gluten may increase the risk even to permanent complications. However, gluten-free diet may cause burden and restrictions in everyday life impairing quality of life. Regular follow-up is recommended to support the treatment and to detect early possible comorbidities and complications, but, in practice, patients are often lost to follow-up. Studies about the significance of follow-up and its optimal implementation are scarce. Pediatric patients form a special group here as they may not even remember the reason for the diagnosis if it was set in early childhood, and the education about the disease and its treatment are often given primarily to the caregivers. Responsibility of the treatment shifts to patients themselves in adolescence at the same time with other significant changes in life and they have more often challenges with gluten-free diet than other patients. Despite this, studies about the transition from pediatrics to adult-care are very few.

This study evaluates 13-19 years old patients diagnosed with celiac disease in childhood (\<16 years of age) and compares them to adolescents without celiac disease in selected variables. Study focuses on healthcare follow-up practices and pilot a CeliCAT transition form in a randomized, controlled study design. The main hypothesis is that structured follow-up and transition of pediatric patients to adult care predicts better health, quality of life and adherence to the dietary treatment later in life. Data is collected with physical examination, questionnaires and with blood and urine samples. Follow-up is arranged at one and three years from the first visit.

Eligibility Criteria:
Inclusion Criteria:

* verified celiac disease diagnosis in childhood (\<16 years of age)
* age 13-19 years at recruitment
* Finnish-speaking

Exclusion Criteria:

* disease or condition preventing the completing of the study questionnaire

Inclusion criteria for controls

* no celiac disease diagnosis
* age 13-19 years at recruitment
* Finnish-speaking
Montelukast as a Controller of Atopic Syndrome

The purpose of the study is to find out if montelukast can be used to treat the various symptoms of allergic syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Wheal diameter at least 4 mm in skin-prick test for both birch and timothy
* Allergic symptoms in both upper airways (allergic rhinitis) and lower airways (asthma-like symptoms or diagnosed asthma) and at least one of the following:

  * Allergic conjunctivitis
  * Atopic eczema
  * Oral symptoms from vegetables or fruits by cross reactivity to birch
  * Urticaria in allergen exposure

Exclusion Criteria:

* Need for regular treatment with glucocorticoids
* Current smoking
* Other major disease or need for regular drug treatment
* Pregnancy