cyrilzakka/clinical-trials huggingface dataset:
GF-NOURISH (Gluten Free Nutrition Optimization Through Ultra-processed Food Reduction and Improved Strategies for Health)

The investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits

Celiac Disease (CeD) is a gluten driven enteropathy that affects up to 3% of the population and typically develops in childhood. Lifelong adherence to a gluten-free diet (GFD) is the primary treatment. Rice, the most common gluten-free substitute grain, naturally bioaccumulates inorganic arsenic. Chronic arsenic exposure may affect neurodevelopment, increase risk of cardiovascular disease and cause kidney damage. In a prior prospective cohort study, the investigators demonstrated that urine arsenic levels increased 2-3 times in newly diagnosed children 6 months after adoption of a GFD. This likely is a consequence of both impaired absorption of vitamin B12 and folate in the small intestine (both nutrients are part of the pathway to excrete arsenic from the body) and increased ingestion of rice products on a gluten-free diet. In particular, gluten-free ultra-processed free foods tend to be specialty products that are made predominantly from rice products, easy for families to identify as safe when avoiding gluten, and rarely fortified with vitamins. Ultra-processed food(UPF) consumption has also been associated with lower perceived quality of life in patients with CeD.

Given the risks associated with gluten-free ultra-processed food, the investigators propose the Gluten Free Nutrition Optimization through Ultra-processed food Reduction and Improved Strategies for Health (GF-NOURISH) study to demonstrate the feasibility and success of a nutritional education program focused on naturally occurring gluten-free foods and minimizing ultra-processed gluten-free foods. The investigators hypothesize that nutritional educational (GF-NOURISH) intervention will have multiple health benefits

The investigators propose to randomize (1:1) 120 children at celiac disease diagnosis to either a novel nutritional education (GF-NOURISH) focused on minimizing ultra-processed gluten free foods or to a conventional GFD nutritional education. Urine/Hair/Toenail arsenic, changes in percent fat free mass, household budgets, diet quality measurements will be evaluated after 6 months on the GFD.

Eligibility Criteria:
Inclusion Criteria:

* Age 2-18 years of age with recent celiac disease diagnosis

Exclusion Criteria:

* Allergic to \<3 of the top 8 food allergens
* Co-morbid conditions treated with dietary modifications or that influence nail arsenic values
The Effect of the Mediterranean Diet on Obstructive Sleep Apnoea-Hypopnoea Syndrome: A Randomised Trial

This study aims to investigate the role of the Mediterranean diet in obese patients with Obstructive sleep apnoea-hypopnoea syndrome.

Obstructive sleep apnoea-hypopnoea syndrome (OSAHS) is considered to be one of the most prevalent sleep-related breathing disorders, with an enormous effect on public health. Approximately 2-4% of the general adult population experiences some degree of this syndrome. This percentage increases even more with obesity, up to 20-40%, especially in individuals with an excessive body mass index (BMI) \> 30 kg/m2. OSAHS is associated with significant systemic consequences, including cardiovascular morbidity and mortality, and the risk increases with the severity of the syndrome. The pathophysiology underlying the link between OSAHS and the cardiovascular system is attributed largely to systemic inflammation and oxidative stress, which are both contributors to endothelial dysfunction. The treatment modalities of OSAHS include continuous positive airway pressure (CPAP), weight loss, upper airway surgery, and medication. CPAP is the first line therapy, as a means of maintaining upper airway patency, and it is well known that this intervention reduces morbidity and mortality. In severe cases of OSAHS the weight loss strategy is essential and must accompany CPAP treatment. A growing body of evidence in OSAHS supports the beneficial role of weight reduction, induced by diet alone or in combination with exercise, leading to a reduction in apnoeas and hypopnoeas.We aim to evaluate the effect of the Mediterranean diet compared with that of a prudent diet on obese OSAHS patients who were treated with CPAP while receiving counselling to increase their physical activity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with apnoea-hypopnoea index \>15/h and Epworth Sleepiness Scale \> 10

Exclusion Criteria:

* Diseases such as ischaemic heart disease, diabetes mellitus, thyroid disorders, and malignancies
* Upper airway surgery
* Gestation
* Alcoholism
* Diet for weight reduction during the last 6 months
* Eating habits close to the Mediterranean diet at the entry phase
* Intake of antioxidant supplements
* Medications affecting weight
* Smoking (in the case of TBARS)
* Therapy with sleeping pills
* Use of anti-depressive medication
* BMI \< 30.0 Kg/m2
Physical Activity and Leisure-time Study (PALS)

Physical inactivity is a major public health problem and a primary contributing factor to the obesity epidemic. While most Americans do not meet the physical activity (PA) guidelines (30 min/day, 5 day/wk), they do report watching several hours of TV each day, and frequently site "lack of time" as a barrier for engaging in PA. The Physical Activity and Leisure-time Study examines an approach convert sedentary TV watching into active TV watching time by having adults step in place during commercials (TV commercial stepping).

This randomized controlled trial will examine the effects of a PA prescription of TV commercial stepping for at least 90 min/day of TV programming, with that of walking at least 30 min/day (30 min walk) on daily step counts, TV viewing, and diet during a 24 week PA intervention. Sedentary, overweight or obese, adults will be randomly assigned to either the TV commercial stepping, or 30 min walk group during a 24-week behavioral PA intervention. Both groups will attend 8 sessions, but receive different PA goals. PA, TV watching time, diet, and anthropometric data will be collected at 0, 12, and 24 weeks. It is hypothesized that the TV commercial stepping condition will, show an equal increase in PA at 12 and 24 weeks as compared to the 30-min walk condition. Neither group is hypothesized to demonstrate changes in TV viewing time, dietary intake, or weight.

Eligibility Criteria:
Inclusion Criteria:

* 25 to 65 years of age
* BMI between 25 and 45 kg/m2
* watch ≥14 hours per week of TV
* ability to follow instructions and record data
* ability to walk 1/4 mile without stopping

Exclusion Criteria:

* history of myocardial infraction, angina, stroke, heart failure, or uncontrolled cardiac arrhythmias
* a resting blood pressure greater than 180 mm Hg systolic and/or 100 mm Hg diastolic
* other physical or medical limitations for engaging in physical activity
* no television in the home
* baseline physical activity level exceeding 7,499 steps per day as determined by the Omron pedometer
* currently participating in a program to increase PA
* intended to move outside the East Tennessee area within the time frame of the intervention
* were pregnant, lactating, less than 6 months post-partum, or planned to become pregnant during the time frame of the intervention
* unwilling to attend group intervention meetings, assessments or to complete an activity diary for the duration of the study.
PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder

This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent will be enrolled into this study and will complete web surveys and telephone interviews conducted by one central site at the following time intervals: months 2, 3, 4, 5 and 6 (± 7 days for each assessment) and months 8, 10, 12, 14, 16, 18, 20, 22 and 24 (± 14 days for each assessment).


Eligibility Criteria:
Inclusion Criteria:

* Enrollment and intervention with the investigational drug in Study PSIL201

Exclusion Criteria:

* Inability or unwillingness to complete study procedures, including regular completion of web surveys and telephone interviews with study personnel
Use of Prophylactic Steroids in the Prevention of Post-thyroidectomy Hypocalcaemia and Voice Dysfunction

Total thyroidectomy for benign surgical pathologies is associated with risks related to temporary hypocalcaemia and vocal quality dysfunction. Dexamethasone, as an anti-inflammatory steroid, has been proposed to have a physiological effect on hypocalcaemia and voice quality. Investigators conducted a double-blinded controlled trial to assess the effect of preoperative dexamethasone on the vocal dysfunction and hypocalcaemia following thyroidectomy


Eligibility Criteria:
Inclusion Criteria:

* Benign thyroid condition.
* Patients without any preoperative corrected hypocalcaemia and voice or vocal quality dysfunction.

Exclusion Criteria:

* Previous thyroid or neck surgery
* Known vocal cord dysfunction on laryngoscopy
* Hearing or voice problems
* History of gastroesophageal reflux and stomach ulcer disease
* Contraindications of steroids
Exploration of Gait Biomechanics and Muscle Pain of the Lower Extremity

This interventional study aims to test gait biomechanics in healthy individuals with and without experimental muscle pain in the lower extremities. The study aims to:

A) Examine how experimental muscle pain in different types of muscles (ankle plantar-flexion, knee extension, and flexion muscles) affects kinematics, kinetics, and muscle activation

Participants will receive six muscle injections: a) Hypertonic saline (painful condition) and b) Isotonic saline (control condition) in 1) m. gastrocnemius, 2) m. semitendinosus, and 3) m. biceps femoris.

The proposed study will be a randomized, crossover design in which experimental pain will be induced in healthy subjects using hypertonic saline injections to three muscles of the lower extremities: The gastrocnemius muscle, the vastus medialis muscle, and the semitendinosus muscle. Participants will be block-randomized to receive an injection in each of the three muscles and will receive either the painful or control condition first for each muscle. The participant will always be blinded to the type of injection received.

Following the injection, there will typically be a 15-minute window of pain (45). Within this timeframe, motion capture will be carried out for both the control and painful conditions. During motion capture, the participants will perform multiple walking trials of approximately 10 meters. The participants will be equipped with electromyography (EMG) sensors on key muscles of the lower extremities. The participants will be asked for NRS ratings every 30 seconds throughout the 15 minutes with expected pain. There will be a 15-minute washout between the muscle injections.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men and women aged 18-45 years

Exclusion Criteria:

* Pregnancy
* Drug addiction, defined as the use of cannabis, opioids, or other drugs
* Previous or current neurologic or musculoskeletal illnesses
* Current pain
* Lack of ability to cooperate
Effects of Resveratrol on Inflammation in Type 2 Diabetic Patients

This research will investigate the effect of resveratrol on inflammatory mediators in type 2 diabetic patients in vivo.

The investigators will also investigate the hypothesis that resveratrol has an antioxidant activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover.

Despite a large body of evidence demonstrating promising effects of resveratrol in rodents, human studies are still lacking and both preventive and therapeutic value of resveratrol in humans remains to be elucidated. The published evidence is not sufficiently strong to recommend for the administration of resveratrol to humans, beyond dietary sources. On the other hand, animal data are promising in prevention of various cancer types, coronary heart diseases and diabetes which strongly indicate the need for human clinical trials.

Furthermore, data are lacking either about safety during long-term administration, or on the efficacy of resveratrol administration in patients with chronic illnesses, such as diabetes mellitus.

The main objective of this study is to investigate the effect of resveratrol on inflammatory mediators in type 2 diabetic patients in vivo.

This research will investigate the hypothesis that resveratrol, when given orally to type 2 diabetic subjects for 24 weeks induces a decrease in values of high-sensitivity CRP (C-reactive protein) (primary outcome measure), IL-6 (Interleukin-6), PTX3 (pentraxin 3).

The investigators will also investigate the hypothesis that resveratrol has an antioxidant activity, improves insulin sensitivity and lipid pattern, down-regulates bone-turnover. Secondary outcomes are therefore variations in the following variables: TAS (total antioxidant status), glycemia, glycated hemoglobin (HbA1c), Homeostasis model assessment of insulin resistance (HOMA-IR), total and HDL-cholesterol, triglycerides, adiponectin, body composition (evaluated by Dual-emission X-ray absorptiometry DXA-), bone mineral density (DXA).

Finally, the investigators are interested in evaluating efficacy, safety and tolerability of two different dosages of resveratrol: 500 mg/day and 40 mg/day.

Eligibility Criteria:
Inclusion Criteria:

1. 35 years of age and older
2. Type 2 diabetes with body mass index (BMI)\<35 kg/m2
3. Subjects on hypoglycemic agents other than insulin
4. Willing to give written informed consent and able to understand, to participate in and to comply with the study requirements.

Exclusion Criteria:

1. Subjects on any antioxidant medication
2. Patient on non-steroidal anti-inflammatory drug, steroids or insulin
3. On any agent with significant antioxidant properties
4. History of drug or alcohol abuse
5. Liver or kidney diseases
6. Any life threatening diseases
7. Allergy to peanuts, grapes, wine, mulberries
8. Pregnant women
9. Coronary event or procedure (myocardial infarction, unstable angina, coronary artery bypass surgery or coronary angioplasty) in the previous four Weeks
10. Subjects on anticoagulants
Influence of Intragastric Fatty Acid Infusion on Behavioral Responses to Positive Emotion Induction in Healthy Subjects

The purpose of this study is to test whether intragastrically infused fatty acid will interact with positive emotion induction and if this effect is mediated by gut hormones.

This study aims at the possible effect of subliminal intragastric administration of fatty acids on responses to positive emotion induction, based on our earlier findings that subjective administration of fatty acid decreases neural responses to negative mood induction (Van Oudenhove et al, J Clin Invest 2011). After screening for exclusion criteria and the participants sign the informed consent form, an intravenous catheter is placed in the forearm, and a naso-gastric tube inserted through the nose. Then the test subject is connected to the equipment in order to record the activity of the autonomic nervous system, via three electrocardiogram electrodes. By using the nasogastric tube we serve a fatty acid solution (Dodecanoic acid, "fatty acid" condition) or a physiological saline solution ( "control" condition) intragastrically. The intragastric administration of low doses of this food ingredient has already been used in several previous studies by our research group and has proven perfectly safe. A positive or neutral emotional state will be induced by the combination of looking at emotional facial expressions and listening to classical music pieces that were previously validated for this purpose; This combination of incentives has already been used in previous studies of our research group. Responses will be measured by means of validated self-report scales and measurements of the vagal tone. We also take blood samples on a regular basis by the intravenous catheter for determination of gastrointestinal hormones, given our hypothesis that this may explain the effect on emotions. After removal of the nasogastric tube, the influence of subliminal administration of fatty acids and emotional state on food intake measured by means of a validated and previously drink test used in which participants "ad libitum" to drink a chocolate milkshake while the emotion-induction by means of classical music pieces continue. Finally, the intravenous catheter is removed.

Eligibility Criteria:
Inclusion Criteria:

* healthy women
* age \> 18 and \< 60.
* Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5% of body weight in the past three months).

Exclusion Criteria:

* chronic medical illness affecting the gastrointestinal, endocrine, cardiovascular or nervous system (risk of) pregnancy history of upper gastrointestinal surgery history of behavioral, therapeutic or surgical treatment aiming at or leading to weight loss/gain psychiatric disorders, including (history of) depression or eating disorders alcohol abuse or dependence regular use of medication, except for oral contraception use of any drugs, including cannabis, during the past 6 months
Feasibility of Expressive Writing for Body Image Distress and Anxiety Among Adolescent and Young Adult Cancer Survivors

Each year, about 89,500 adolescents and young adults (AYAs; 15-39 years old) are diagnosed with cancer and up to 60% experience body image (BI) distress. BI is largely developed in adolescence and young adulthood and has implications for self-identity and quality of life. Cancer itself and its associated treatments precipitate changes to appearance as well as body sensation and function, all of which can alter BI and lead to increased anxiety. An in-home BI-focused expressive writing (EW) program offers a promising outlet for addressing BI distress and anxiety in a way that eliminates constraints of clinical time and specialist availability.

There are no recommended interventions to help AYA cancer survivors cope with BI distress. To address this knowledge gap, the objective of this this pilot randomized-controlled trial is to determine the feasibility of a four-week BI-focused EW intervention to decrease BI distress and anxiety among AYA cancer survivors with the hypothesis that this intervention will reduce BI distress and anxiety.

Protocol was updated to make the previous secondary outcome measures now exploratory

Eligibility Criteria:
Inclusion Criteria:

* Age 15-39 years
* History of one or more cancer diagnoses with all treatment (surgery, chemotherapy, radiation) completed ≥ 3 months before enrollment)
* BIS ≥10 at time of screening
* Ability to provide consent or assent and parental consent if applicable.

Exclusion Criteria:

* Plan to receive surgery, radiation, chemotherapy (including biologic agents, immunotherapy, and other targeted agents) for cancer treatment during the study period (from baseline assessment through post-four-week assessments and interview). Participants may continue with surveillance (such as imaging or biopsies) during the study period.
* Initiation of new treatments for body image distress or anxiety (e.g., pharmacologic, psychotherapy) ≤8 weeks prior to study enrollment. Although, participants may continue psychosocial or pharmacological treatments for anxiety or body image distress if the treatment were initiated at least eight weeks prior to study enrollment, the dose has not changed, and they report clinically relevant body image distress.
* History of limb-altering surgery or amputation (surgical exclusions are based on the premise that significant appearance-altering surgeries may impact body image distress differently than other cancer therapies)
* Currently receiving end-of-life care
Evaluation of Tranexamic Acid for Angiotensin-converting Enzyme Inhibitor-induced Angioedema in the Emergency Department

Angiotensin-converting enzyme inhibitor ACEi induced angioedema ACEi-AE is defined as physical swelling of the deep skin layers or mucous membranes due to increased vascular permeability and leakage of fluid into the interstitial space caused while taking an ACEi

Angiotensin-converting enzyme inhibitor ACEi induced angioedema ACEi-AE most commonly affects the lips, mouth, face, upper airway, and less commonly the gastrointestinal tract. This condition may lead to life-threatening airway compromise which would require emergent intubation. Currently, strong evidence is lacking to help guide management of ACEi-AE in the emergency department (ED).

Eligibility Criteria:
Inclusion Criteria:

•Patients must be ≥ 18 years old, be diagnosed with suspected ACEi-AE (with ACEi use). ACEi use is defined as patient-reported use or evidence indicating use listed in the chart.

Exclusion Criteria:

•Patients will be excluded if they have an allergy to TXA or any components of the formulation, present with an urticaria, have a personal or family history of hereditary angioedema, or received TXA administration in another department besides the ED.
Evaluation of Age-related Skin Changes Using Clinical Probe Measurements and Imaging Modalities in Chinese Subjects

Evaluation of age-related skin changes using clinical probe measurements and imaging modalities in Chinese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Chinese subjects
* Subject agreeing to complete all study required procedures.
* Subject having given freely and expressly his/her informed consent.

Exclusion Criteria:

* Pregnant or nursing woman or planning a pregnancy during the study.
* Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
* Subject in a social or sanitary establishment.
* Subject participating to another research on human beings or being in an exclusion period for a previous study.
* Intensive exposure to sunlight or UV-rays within the previous month and foreseen during the study.
* Subject who underwent tissue augmentation with dermal fillers including HA, calcium hydroxylapatite, autologous fat, mesotherapy, or other cosmetic procedures (eg, face-lift, laser, photomodulation, intense pulsed light, radiofrequency, dermabrasion, chemical peel, or other ablative procedures) in the face within 12 months before study entry or was planning to undergo any such treatment during the study.
* Subject who underwent treatment with botulinum toxins in the face or neck within 6 months of study entry or was planning to undergo such treatment during the study.
* Subject who ever received semi-permanent fillers or permanent facial implants (eg, poly-L-lactic acid, polymethylmethacrylate, silicone, expanded polytetrafluoroethylene) anywhere in the face or was planning to be implanted with any of these products at any time during the study.
* Subject with current cutaneous inflammatory or infectious processes (eg, acne, herpes), abscess, an unhealed wound, or a cancerous or precancerous lesion on the face that could interfere with measurements.
* Subject having changed, started or stopped any hormonal treatment or any treatment likely to have an impact on skin condition (over-the-counter or prescription, oral or topical, anti-wrinkle products on the face), within 30 days prior to enrollment or is planning to begin using such products during the study.