cyrilzakka/clinical-trials huggingface dataset:
Effect of an Intervention Program of Adapted Physical Activity Combined With Compensatory Nutrition in Patients With Constitutional Thinness

Constitutional Thinness (CT) is a form of stable thinness without malnutrition but with resistance to weight gain, affecting approximately 1% of the general population. The clinical consequences are numerous and the pathophysiology remains poorly understood.

Currently, conventional management involves a high-calorie and frequent diet, combined with the avoidance of endurance physical activity, although there is no significant evidence of its effectiveness.

Our hypothesis is that an adapted physical activity program (APA) combined with compensatory nutrition (CN) could help these patients gain lean mass (muscle mass).


Eligibility Criteria:
Inclusion Criteria:

* Gender: Female
* BMI: ≤ 18.5 kg/m²
* Weight Stability: Stable weight for at least 3 months
* Age: 18 to 50 years old at the inclusion visit
* Diagnosed with Constitutional thinness

Exclusion Criteria:

* Pregnancy, Parturition, or Lactation
* Legal Restrictions: Individuals deprived of liberty, involuntarily hospitalized, or hospitalized for reasons other than research purposes, adults under legal protection (guardianship or curatorship) or unable to provide consent
* Eating Disorders: Individuals with eating disorders (DSM IV and 5 criteria)
* Excessive Alcohol Consumption: Consumption exceeding the equivalent of 10 glasses of wine per week
* Severe Progressive Conditions: Progressive severe conditions (e.g., diabetes)
* Intense Physical Activity: Individuals engaging in intense physical activity (\> 3 sessions per week)
* Heavy Smoking: Significant smoking (\>10 cigarettes per day)
* Psychiatric Conditions: Presence of depressive or psychiatric conditions requiring antidepressant or psychotropic treatment
* Medical or Surgical History: Medical or surgical history deemed incompatible with the study by the investigator
* MRI Contraindication: Individuals with contraindications to MRI will not undergo spectro-MRI analyses
Adaptive Goal-Directed Adherence Tracking and Enhancement

Talaria, Inc., has designed an adherence tracking and enhancement system, called AGATE, which uses the text messaging and internet capabilities of modern cellular phones to address the problem of medication adherence in clinical care and clinical trial contexts. This trial will evaluate whether AGATE improves medication adherence in the context of a pharmacotherapy trial of naltrexone to treat problem drinking. All participants will be treatment-seeking problem drinkers who will receive naltrexone and medication monitoring over 8 weeks.

The purpose of the naltrexone trial is to evaluate whether AGATE effectively measures and enhances medication adherence in the context of naltrexone treatment for problem drinking. Participants will be heavy/problem drinkers, recruited from the greater Albuquerque area, who are interested in either reducing or stopping their drinking and deemed to be candidates for naltrexone pharmacotherapy by the study psychiatrist, Dr. Arenella. All participants will be prescribed naltrexone, 50 mg, once daily, for eight weeks, and receive smartphones. Participants will be randomly assigned to receive either AGATE or SASED, a web-based alcohol and side-effects diary via smartphone. The primary outcome will be percent of scheduled doses that were taken during the eight week trial, as measured by the Medication Event Monitoring System (MEMS, Aardex Group, Union City, CA), pill counts, and using the timeline follow-back (TLFB) method.

Eligibility Criteria:
Inclusion Criteria:

* problem or heavy drinkers
* age 21-55 years old
* located in the greater Albuquerque NM area
* interested in either reducing or stopping their drinking
* candidates for naltrexone pharmacotherapy

Exclusion Criteria:

* participation in other naltrexone study
* unable to operate a smartphone
* significant psychiatric or physical illness
* current drug dependence
* current regular opioid use
* any recent nonmedical opioid use
* any lifetime opioid dependence
Ketogenic Diet Drink Study

An evaluation of the tolerance, compliance, acceptability and safety of a nutritionally complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years, adolescents and adults with intractable epilepsy or other disorders where the KD is indicated.

An evaluation of the tolerance, compliance, acceptability and safety of a nutritionally complete liquid feed for use as part of the ketogenic diet (KD) in children 8+ years, adolescents and adults with intractable epilepsy or other disorders where the KD is indicated.

Study is conducted over 59 days:

3 day baseline period - Patient continues on whatever dietary regimen they were on before joining the study (this may be a ketogenic diet for existing patients).

28 day control period - Patient begins ketogenic diet (if they are not already on one), and continues this for 28 days WITHOUT the study product. Patients already on a ketogenic diet continue this as normal.

28 day intervention period - A set amount of the study product is incorporated into the patient's ketogenic diet.

Data is captured by the HCP in the case report form at baseline, mid study and end of intervention, and by the patient daily throughout in a patient questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 8 years of age or older
* Diagnosed with intractable epilepsy or another disorder where the KD is indicated
* Motivated to follow the KD for at least the duration of the trial period
* Either currently on a KD, or referred to start a KD
* Likely to benefit from Ketocal 2.5:1
* Written informed consent from patient and/or parent/carer, or completed consultee declaration form
* Willing to take finger prick blood samples to measure ketone levels

Exclusion Criteria:

* Being pregnant or planning pregnancy
* Requiring parenteral nutrition
* Major hepatic or renal dysfunction
* Participation in other clinical intervention studies within 1 month prior to entry of this study
* Allergy to any of the study product ingredients
* Investigator concern around willingness/ability of patient or parent/carer to comply with protocol requirements
* Any contraindications for the use of the ketogenic diet
* Significantly underweight (Body Mass Index \<18.5)
Ankle - Brachial Index Measurement in Atrial Fibrillation

Consecutive patients with atrial fibrillation will be admitted to the hospital for electrical cardioversion. Ankle brachial index will be measured three times with oscillometric method and three times with doppler method. Two study sessions will be performed: the first before and the second after electrical cardioversion. The first session will be ended before anesthesia. The second session will be started before a conscious patient will be transported from intensive care unit to general ward.

All the measurements will be taken in the intensive care unit at an ambient temperature of 21° C, after patients will give their written informed consent to participate in the study. All patients will be awake, fasting and in the supine position. ABI will be measured according to the guidelines issued by AHA. Systolic blood pressure will be measured using a Doppler device (Echo Sounder ES-101EX, Hadeco, Japan) and a validated and calibrated aneroid sphygmomanometer (Minimus II, Rister, Germany). Measurement of ABI using oscillometric method will be performed using WatchBP Office ABI system (Microlife WatchBP AG, Widnau, Switzerland). The appropriate cuff size will be used with the width of the cuff being at least 40% of the limb circumference. The arm with higher systolic blood pressure will be used to calculate the ABI. Higher systolic blood pressure measured on the posterior tibial or dorsalis pedis artery will be used to calculate the ABI. During both study sessions ABI measurements will be repeated 3 times with each method in the reverse order of the preceding measurement e.g., in the case of the initial counterclockwise sequence: right arm, right popliteal, right dorsalis pedis, left popliteal, left dorsalis pedis, left arm, right arm, the clockwise sequence will be used, starting and ending with the left arm. The same sequence of limb pressure measurements will be used used during the study.

A sample size calculation was based on the preliminary observations made by the study team. It was calculated that the study sample size of 79 subjects would be needed to detect a difference of 0.1 in the ABI measured in sinus rhythm and during atrial fibrillation, with a two-tailed α of 0.05 and a (1-β) of 0.90. The investigators initial estimate of sample size of 115 patients incorporated an assumption of dropout due to non-effective electrical cardioversion, patient decision to quit study or failure to obtain adequate ABI.

The measurements will be repeated three times with each method and for the each method the mean will be used for the calculations. Investigator - study nurse, trained at the vascular department, will perform all ABI measurements.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing electrical cardioversion due to atrial fibrillation

Exclusion Criteria:

* Circulatory instability
* Use of vasoconstrictive agents
* Limb trauma
* Upper limb artery stenosis
Observational Study of Correlation Between Recurrent Basal Cell Carcinoma and Localisation

.During one year all the resected basal cell carcinomas (BCC) analyzed in Montpellier University Hospital Anatomopathology unit were included in this study. Localisation and histological characteristics were collected. All the recurrences of BCC were searched from the medical records (or histopathology request form).

From 804 BCC, 48 were recurrent BCC with or without complete first resection. Patients with recurrent BCC were contacted to obtain agreement and more informations about the first resection and some clinical informations like sun exposure and phototype.

The statistical analysis focused on the localisation of recurrent BCC (with a complete first resection) compared to localisations of primary BCC in this population. The goal was to identified localisations with an increased risk of recurrences.


Eligibility Criteria:
Cohort :

Inclusion criteria:

- Patients with resected BCC

Exclusion criteria:

* Biopsies of BCC,
* revised surgery of incomplete resection.

Cases :

Inclusion criteria:

-Recurrent BCC with complete first resection

Exclusion criteria:

- Recurrent BCC with incomplete first resection, Patients with Gorlin syndrome (a genetic disease that increase risk of BCC)
Effect of Smoking on Pain and Atherosclerosis in Patients With Rheumatoid Arthritis

Primary aim: examine a possible connection between cigarette smoking, disease activity and perceived pain in patients with rheumatoid arthritis.

Secondary aim: Evaluate cardiovascular risk in patients with rheumatoid arthritis.

The study will recruit patients with rheumatoid arthritis (age 20-60 years) at rheumatology clinics in Västra Götaland. All patients meeting the inclusion criteria will be informed of the study in a letter and later contacted by the study coordinator and if interested booked for a study visit at the rheumatology clinic. At the study visit the patients will meet with rheumatologist for clinical examination of their joints and tenderpoints. An algometer is used for objective quantification of the patients pain sensitivity. Questionnaire regarding medical treatment, other diseases, smoking habits, subjective pain, fatigue, anxiety and depression, ability to work and ability to perform everyday activities are filled out by the patient.

Height, weight, blood pressure, blood, urine and fat biopsy will be collected for analyse.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 20-60 years diagnosed with rheumatoid arthritis

Exclusion Criteria:

* Other serious physical or mental illness, lack of knowledge in Swedish language making answering the questionnaires impossible
Retinal Deep Phenotyping.TM

This study aims to collect a baseline dataset of MHRC retinal scans that will be used for the pre-training of deep learning models from the hyperspectral retinal image phenotypic features that may form the basis for multiple future classification applications.

As an exploratory study, there are no endpoints per se, however, the following sub-objective will be evaluated for determining the success of this study:

* Collection and characterization of MHRC retinal images from at least 250 participants that score at least 80 on the real-time Quality Index (included in the MHRC software).
* Development of at least one (1) DL model of the retina. Models may be used for the development of novel classifier tests and potential use in a clinical setting.

This is an exploratory, observational, cross-sectional, multi-site study designed to collect a baseline dataset of MHRC retinal image scans for use in Deep Learning models. Subjects will be recruited from eye clinics where patients will undergo mydriasis (pupil dilation) as part of their clinical visit. Eligible participants will be provided information about the study and delegated site personnel will assist with the Informed Consent process. If a participant provides their Informed Consent, they will be enrolled in the study and undergo a single retinal imaging session with the Optina MHRC device, on one or both eyes.

Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years and older who will undergo mydriasis (pupil dilation) as part of their eye clinic visit.

Exclusion Criteria:

* Contraindications for mydriatic fundus imaging.
* Pupil dilation contraindicated (due to a pathology, or presence of 3 quadrants with Van Herick grading of 0 or 1 without iridotomy).
* Inadequate pupil dilatation (\< 6mm diameter) preventing uniform illumination of the retina with the MHRC.
* Refractive error outside the range of -15 D to +15 D.
* Deficient visual fixation (inability to fixate for at least 2 s)
* Inability of obtaining at least 3 images of satisfactory quality with the MHRC per the Optina Diagnostics quality index software and /or per the eye specialists' evaluation.
Do Sustainability Labels Lead to More Sustainable and Healthier Food Choices?

This study tests the effect of two climate change menu labels, one indicating 'low climate impact' and the other indicating 'high climate impact' on ordering choices and perceptions of healthfulness of food ordered in an online randomized experiment.

The objective of this study is to examine how climate impact menu labels influence US adults' ordering and perceptions via an online randomized experiment. Participants were randomized to view one of 3 fast food menus online and then choose an item that they would like to order. One menu 'control' had QR code labels, the second had "low climate impact" labels on items with lower greenhouse gas emissions (vegetarian, chicken or fish items), the third had "high climate impact" labels on beef items. After the ordering task participants answered questions about what label they saw on the menu, how healthy they thought the item they ordered was, and how much the label discouraged them from eating high climate impact items.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* Member of the National Opinion Research Center (NORC) Amerispeak Panel

Exclusion Criteria:

* \<18 years of age
* completed the survey in \< 1/3 of the median duration
* skipped or refused more than 50% of the survey questions
Effect of Hand Holding on Pain and Anxiety

It was aimed to examine the effect of the hand holding method applied during intramuscular injection on pain and anxiety.

This study was designed as a pre-test-post-test regular parallel group, randomized controlled experimental design. The research will be carried out in the Adult Emergency Service of the Ministry of Health of the Republic of Turkey, Konya City Hospital. Patients will be randomly divided into two groups: handholding (52) and control group (52). For the Hand Holding Group: After the patient is positioned appropriately, the patient's hand will be held by the researcher. Once the intramuscular injection is completed, the patient's hand holding will be stopped. For the Control Group: No application will be made during intramuscular injection in the control group. The primary outcome of this study is to determine patients' pain scores during the intramuscular injection procedure. The secondary outcome is to determine the anxiety levels of patients.

Eligibility Criteria:
Inclusion Criteria:

* Having vitamin B 12 1000 mcg/ml (1 ml ampoule) intramuscular treatment,
* Being literate,
* Are between the ages of 18-65,
* No visual, hearing, sensory or motor loss or cognitive impairment,
* Not using centrally or peripherally acting analgesics or sedatives,
* There is no scar tissue, incision, lipodystrophy or signs of infection on the skin of the injection area,
* Having a body mass index between 18.5 and 29.5,
* Injected into the ventrogluteal area,
* Individuals who agree to participate in the research will be included.

Exclusion Criteria:

* Those with chronic pain,
* Having a psychiatric disorder,
* Foreign nationals,
* Patients with contact-communicable diseases will be excluded from the study.
A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana

"A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana" is intended to help mitigate stressors that may contribute to poor behavioral and mental health in rural Montana teachers. The immediate goals of this study is to promote student health by supporting teacher wellbeing through a remotely-delivered trauma-informed yoga intervention.

Project Summary: "A Trauma-Informed Intervention for Positive Youth Development and Teacher Wellness in Rural Montana" is intended to help mitigate stressors that may contribute to poor behavioral and mental health in rural Montana teachers. The immediate goal of this study is to promote student health by supporting teacher wellbeing through a remotely-delivered trauma-informed yoga intervention.

Specific Aim: Expansion of previous pilot study to teachers in the southwestern Montana school district.

Methods: To explore scalability to rural communities without access to yoga instructors, we will implement a limited feasibility study of online yoga delivery to classroom teachers. This study will enroll a minimum 30 Livingston teachers (taught trauma-informed yoga via Zoom), twice weekly for 45-minute trauma-informed yoga sessions during the 6-week intervention period. No participants were assigned to the "No Intervention" arm. To measure physical health outcomes, pre, mid-, and post-intervention cortisol testing will be utilized to evaluate any changes in teacher stress levels before and after the program. Heart rate variability will also be assessed for teachers pre, mid-, and post-intervention using the HeartMath Inner Balance PPG sensor and Em Wave Pro Plus software. To assess behavioral health, pre- and post-survey instruments will collect targeted wellness/mental health data from teachers. An Adverse Childhood Experience Self-Reporting Screener will also be given to participants to establish a baseline of exposure to childhood trauma, which is closely correlated with health outcomes. Teachers will also complete the Teachers' Sense of Self Efficacy Survey and the Professional Quality of Life Index, which are linked to teacher mental health, retention, and career satisfaction.

Eligibility Criteria:
Inclusion Criteria:

* Any teacher currently employed by the Livingston school district who wishes to participate in the intervention (up to 35 participants)

Exclusion Criteria:

* Only teachers will be considered for this study (i.e., no school staff, administrators, etc.)
Salt-FA to Increase Folate Levels

Question: How effective is folic acid-fortified iodized salt in increasing serum folate concentrations among non-pregnant and non-lactating women of reproductive age? Hypothesis: Folic acid-fortified iodized salt can increase serum folate levels and serve as a policy consideration in salt fortification with both iodine and folic acid to reduce serious and fatal birth defects.

Salt is an ideal vehicle for fortification because its universal consumption and often centrally processed with established distribution channels. Over 70% of households globally have access to iodized salt. Considering the success of salt iodization, it is logical to use the existing infrastructure to provide folic acid through this dietary mechanism.

AIM:To assess increase in blood folate concentrations among women of reproductive age after they consume folic acid-fortified iodized salt.

OBJECTIVES :

1. To examine the effect of consumption of salt fortified with folic acid on serum/plasma folate concentrations among women of reproductive age.
2. To estimate the raise in serum iron, B12 and folate levels after 3 months of study salt consumption.

Eligibility Criteria:
Inclusion Criteria: • Willing to voluntarily participate in the study

* Can comprehend and comply with study requirements
* Aged between 18 and 45 years.
* No documented issues with child bearing potential
* Resident of the area of study for duration of study.
* Consume only study salt during study

Exclusion Criteria:

* Taking multivitamins or FA during study
* Pregnant or lactating at recruitment or during study
* Co-morbidities such as Malabsorption disorders, severe anemia (Hgb \<8.0 g/dL), uncontrolled hypertension, (SBP ≥140 mm Hg or DBP ≥90 mm Hg), HIV, active TB or malaria infection
* History of prior SBA delivery
* Pre-existing medical conditions (i.e., cancer or need for regular medications)
Preloading to Prevent Hypotension During Cesarean Section

Whether the usage of non-invasive arterial blood pressure monitor to guide fluid therapy in caesarean section can effectively reduce the incidence of hypotension and fetal complications.

Spinal anesthesia in the cesarean section often causes significant peripheral vascular dilatation, decreases blood pressure and cardiac output reduction which leads to maternal nausea, vomiting, dizziness and uteroplacental hypoperfusion. Infusion therapy and the use of vasopressor can prevent and treat the incidence of hypotension. Appropriate fluid therapy can not only maintain maternal tissue perfusion, but also reduce uteroplacental hypoperfusion. In the present study, perioperative goal directed fluid therapy is used. The non-invasive continuous hemodynamic monitor is used in this study, and the parameters (blood pressure (BP), stroke volume(SV), stroke volume variation (SVV), cardiac output (CO)) are used to determine the parameters of the blood transfusion in cesarean section as infusion guidelines. The application of Clearsight system to the pre-infusion of target-guided crystalloid solution is compared with the infusion of quantitative crystalline solution in the hope of reducing the incidence of maternal hypotension, reducing the use of vasopressin, improving uteroplacental perfusion and reducing the incidence of fetal acidosis.

Eligibility Criteria:
Inclusion criteria:

1. 20-45 y/o parturient
2. Receive spinal anesthesia (SA) or combined spinal-epidural anesthesia (CSA) to undergo cesarean section

Exclusion criteria:

1. Emergent C/S
2. BMI\>35kg/m2
3. Height \<150cm or \>175 cm
4. Patients with major cardiovascular disease, preeclampsia or eclampsia.
5. Gestational age \< 36wks
6. Multiple pregnancy