cyrilzakka/clinical-trials huggingface dataset:
Effects of a Portfolio Diet on NAFLD in Type 2 Diabetic Patients

Patients with type 2 diabetes and non-alcoholic fatty liver disease will be enrolled.

According to a parallel design, the participants will be randomized to a Portfolio diet or a monounsaturated fatty acid (MUFA)-rich diet (used as control) for 8 weeks.

At the beginning and at the end of the trial, the participants will undergo a MRI spectroscopy to evaluate fatty liver content. Moreover, the participants will undergo a test meal resembling the nutritional composition of the assigned diet to evaluate fasting and postprandial metabolic response.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes
* non-alcoholic fatty liver disease (evaluated by US)
* HbA1c \<7.5%
* LDL cholesterol \<130 mg/dl

Exclusion Criteria:

* hypoglycemic therapy with sodium-glucose cotransporter (SGLT-2), pioglitazone and glucagon-like peptide (GLP-1) analogues
* severe liver and kidney failure
* recent cardiovascular events (prior 6 months)
* any other acute/chronic disease (anemia, cancer, BPCO)
Episodic Future Thinking, Loss Aversion and Cigarette Smoking

Controlled laboratory experiment to examine whether Episodic Future Thinking influences loss aversion and cigarette smoking among adult individuals who currently smoke cigarettes daily.

Specific Aim 1: Examine in a controlled laboratory study using a randomized parallel-group design whether an intervention that increases LA among 138 current adult daily cigarette smokers (≥21 years; 50% male/50% female) also (1) decreases cigarette smoking and (2) can improve with practice and (3) sustain effectiveness at a follow-up assessment. Potential influence of DD, other self-control, and potential sociodemographic confounders will be accounted for in all analyses.

Hypothesis 1.1: EFT will increase LA and reduce cigarette smoking (i.e., smoking rate). (Primary) Hypothesis 1.2: Changes in LA will mediate the effect of EFT on cigarette smoking independent of changes in DD, and relevant self-control related factors. (Primary) Hypothesis 1.3: EFT effects will be greater following Extended compared to Brief training. (Secondary) Hypothesis 1.4: Changes in LA and smoking rate sustained at follow up will be mediated by EFT habit learning indexed by the perceived automaticity of cue generation with extended EFT practice. (Exploratory)

Eligibility Criteria:
Inclusion/Exclusion Criteria

Inclusion criteria:

1. Adult ≥ age 21 years.
2. Able to provide informed, written consent.
3. Smoke an average of at least five (5) cigarettes per day for at least one year.
4. Breath CO levels \> 8 ppm. If breath CO is less than 8 ppm, we will administer a urine test (NicAlert Strip) and include if result is greater than 2.
5. Desire to quit smoking, but not actively trying to quit or currently taking medications to aid smoking cessation (e.g, varenicline, bupropion).
6. US citizen or a permanent resident alien with a green card
7. Comfortable reading and writing in English

Exclusion criteria:

1. Currently seeking treatment for smoking cessation.
2. Use of tobacco products other than traditional combusted cigarettes on more than 9 of the previous 30 days
3. Positive urine toxicological screen for illicit drug use (i.e., amphetamine, methamphetamine, cocaine, barbiturates, benzodiazepines, buprenorphine, opiates, methadone, oxycodone, phencyclidine).

a. A positive test for marijuana (THC) will not result in exclusion from the study.

d) Breath alcohol level (BAL) at \<.01 (Alco-Sensor IV, Intoximeter, Inc., St Louis, MO) at intake.

a. Participants failing the toxicological screen will be allowed to re-screened for the study. These participants will complete the informed consent process an additional time before being re-screened.

e) Recent or current psychiatric episode to be determined with DSM-V criteria. f) Non-correctable vision or hearing impairments. g) Inability to independently read and comprehend written materials (consent form, other study materials and measures).

h) Currently pregnant (to be determined with a pregnancy test) or trying to become pregnant.

i) Currently breastfeeding. j) Exclusive use of "roll your own" cigarettes.
Landmark Guided Intercostobrachial Nerve Block Versus Serratus Plane Block After Supraclavicular Plexus Block for Anesthesia in Creation of Arteriovenous Fistula in the Medial Side of the Arm

This study aims to compare the role of ultrasound-guided and landmark-guided intercostobrachial nerve block and serratus plane block after supraclavicular plexus block for anesthesia in the creation of an arteriovenous fistula in the medial side of the arm.

Brachial plexus block (BPB) is usually utilized for proximal arm arteriovenous access creation. It has been suggested that supraclavicular brachial plexus block (SCPB) could be an alternative and provide comparable effective anesthesia and postoperative analgesia for arm surgery, with a reduced incidence of adverse events, including hemidiaphragmatic paresis.

By performing SCPB, the inner part of the arm is not completely anesthetized because this part of the arm is innervated by the lateral cutaneous branch of the second intercostal nerve (intercostobrachial nerve (ICBN)) and the medial branch of the brachial cutaneous nerve.

Serratus plane block (SPB) was first defined in 2013 by Blanco et al. This block provides anesthesia and analgesia in the hemi-thorax, where it is applied to block the thoracic intercostal nerves, in addition to the axillary region and shoulder posteriorly.

Eligibility Criteria:
Inclusion Criteria:

* Age from 18 to 65 years.
* Both sexes.
* American Society of Anesthesiology (ASA) physical status I-II.
* Scheduled for creation of arteriovenous fistula in the medial side of the arm.

Exclusion Criteria:

* Allergy to local anesthetics.
* Drug addiction.
* Coagulation abnormalities.
* Body Mass Index (BMI)≥35 kg/m2.
* Upper extremity neuropathy.
* Vasculitis.
* Unstable hemodynamics.
* History of seizures or mental illness.
* Severe heart, kidney, and liver diseases.
* Pregnancy.
Eating Mindfully to Prevent Weight Regain

The overall objective of this study is to evaluate the efficacy of a mindfulness-based intervention to prevent weight regain in weight-reduced adults.

Specific Aim 1: Determine the effect of MORE on weight loss maintenance.

Hypothesis:

MORE will result in less weight regain compared to CON after the 8-week intervention, and benefits will be sustained after 6-month of follow-up.

Specific Aim 2:

Determine the effect of MORE on reward-related behavioral processes (e.g., food cravings) and ad libitum energy intake.

Hypothesis:

MORE group will demonstrate changes in eating behaviors and energy intake associated with preventing weight regain compared to CON immediately after MORE and after 6-months of follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65
* Bariatric Surgery patients: 12-18 months post-operation.
* Medical weight loss patients: patients of the bariatric weight loss clinic, weight loss of 7% body mass via intentional weight loss within past 6 months; BMI \>25 kg/m2 prior to intentional weight loss; stable for 3 months on medications.
* Lifestyle weight loss: weight loss of 7% body mass via intentional weight loss within past 6 months; BMI \>25 kg/m2 prior to intentional weight loss.

Exclusion Criteria:

* Uncontrolled cardiovascular, metabolic, renal, or pulmonary disease; cancer treatment in past 5 years; untreated thyroid disease or other medical condition affecting weight or energy metabolism; severe food allergies; women who are pregnant, lactating, or planning pregnancy during participation in the trial; active psychiatric issues
* Additional criteria specific to patients with history of bariatric surgery: \<12 months post-op; weight regain of \>5% of body mass postoperation; history of admittance to rehabilitation facility; history of post-op complications that require recent inpatient management; patients who were required to stay in the hospital \>1 week post-op; revision surgery patients; heart failure patients.
Erector Spinae Plane Block for Paediatric Upper Abdominal Surgery

Upper abdominal surgeries are associated with severe postoperative pain. Thus, maintaining effective postoperative analgesia in the paediatric age group is very crucial in terms of future pain perception and chronic pain development. Erector Spinae Plane Block (ESPB) is an interfascial plane block characterized by its ease of application and low complication rates with the introduction of ultrasonography. The aim of this study is to investigate the analgesic effects of ESPB in this particular age-group.


Eligibility Criteria:
Inclusion Criteria:

* ASA I - II.
* Elective open upper abdominal surgeries, e.g., open cholecystectomy, splenectomy, pyeloplasty, renal cysts excision, partial or total nephrectomy.

Exclusion Criteria:

* Patient's next of kin refusal.
* Allergy to local anaesthetics.
* Infection at the site of injection.
* Coagulopathy.
"Beverage Hydration Index" of Commercial Therapeutic Beverages

The "beverage hydration index" (BHI) assesses the hydration potential of any consumable fluid relative to water. The BHI is a relatively new metric. Our purpose was to assess the BHI of beverages never previously tested, including an amino acid-based oral rehydration solution (AA-ORS), a glucose-containing ORS (G-ORS) and a sports drink (SD) compared to water (control).

The "Beverage Hydration Index" (BHI) was created to assess the degree to which beverages "hydrate", by measuring fluid retention after ingesting a 1 liter bolus and comparing it to water. Drinks with carbohydrates and electrolytes would traditionally be expected to score higher on the BHI due to glucose-sodium cotransport at the gut and osmolality approaching isotonicity with blood. One recent study reported that an oral rehydration solution (ORS) scored better than water, but a "sports drink" did not. No "optimal" BHI beverage composition has been described, nor has an optimal osmolality. Recently, a hypotonic amino acid-based rehydration beverage was developed to take advantage of amino acid-sodium cotransport, thus obviating the need for carbohydrate. However, the BHI of this beverage has not yet been assessed. The purpose of this investigation was to assess the hydration potential of this novel beverage in comparison to a commercially available carbohydrate-containing sports drink and oral rehydration solution.

Eligibility Criteria:
Inclusion Criteria:

* Healthy male or female
* Aged 18-35
* BMI 18-27 kg/m2
* No known cardiovascular, renal or metabolic disease
* Moderately active
* Moderate alcohol use

Exclusion Criteria:

* Overweight or obese (BMI \>27 kg/m2)

  * Competitive athletes during competition season
  * Current or former cardiovascular, renal or metabolic disease
  * Habitual consumption of alcohol (\>21 units/week) or regular (\>1/week) high (10 units) intake\*
  * History of psychiatric illness
  * Actively seeking to gain or lose weight
  * Currently taking prescribed medication

    * Example, a 750 ml bottle of wine at 12% ABV contains 0.750 Liters \* 12 = 9 units
Sphenopalatine Ganglion Block to Prevent Shoulder Pain After Laparoscopic Bariatric Surgery

The purpose of this study is to determine the efficacy of sphenopalatine ganglion (SPG) block to prevent shoulder tip pain following primary laparoscopic gastric banding, band revision, band replacement, primary sleeve gastrectomy or revision of sleeve gastrectomy. Shoulder tip pain (STP) is a common problem after laparoscopic surgery, manifesting in the post-anesthesia care unit and for days or possibly weeks thereafter (Dixon 2005). Systemic analgesics including opioids and non-steroidal anti-inflammatory drugs (NSAIDs) do not reliably relieve STP. This study is designed to determine if the SPG block, a simple and low-risk procedure, effectively treats STP after laparoscopic bariatric surgery.

This is a randomized, placebo-controlled, parallel group prospective, double-blind study. The primary outcome variable will be change in STP from \> 4 before to after treatment in the PACU after primary laparoscopic gastric banding, band revision, band replacement, sleeve gastrectomy, or revision of sleeve gastrectomy. Investigators hope to achieve a decline in STP in 2 units after treatment.

Eligibility Criteria:
Inclusion Criteria:

* Elective primary laparoscopic gastric banding surgery.
* Laparoscopic band revision surgery
* Laparoscopic band replacement surgery.
* Sleeve gastrectomy.
* Revision of sleeve gastrectomy.
* American Society of Anesthesiologists Class 2 or 3.
* No allergy to study drugs.
* Facility with English language to allow compliance with study protocol.

Exclusion Criteria:

* American Society of Anesthesiologists Class 4 or 5.
* Allergy to lidocaine or to any local anesthetic
* Allergy to oxymetazoline (Afrin)
* Pregnancy
* Bleeding diathesis
* Known nasal pathology including active sinusitis
* Previous nasal surgery
* Preoperative anticoagulant use OTHER THAN aspirin 81 mg and/or heparin 5000 U SQ bid administered for DVT prophylaxis.
* Acute psychiatric disease
* History of chronic right or left shoulder pain
* Current opioid use
* Any patient that the study team feels will be unable to comply with all protocol related procedures
* Concurrent participation in another clinical trial
To Calculate the Pharmacokinetics (Concentration of Compound in and Rate of Excretion From the Blood) Following a Very Low Dose of Compound Which Will Not Have Any Pharmacological Activity

The purpose of this study is to calculate the pharmacokinetics (concentration of compound in and rate of excretion from the blood) following a very low dose of compound which will not have any pharmacological activity and to monitor for the safety and tolerability of each of the compounds in the study.


Eligibility Criteria:
Inclusion Criteria:

* healthy male subjects between the ages of 18 and 50 years inclusive. (healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination including blood pressure and pulse rate measurement, 12-lead ECG and clinical laboratory tests)
* Body Mass Index (BMI) of 17.5 to 30.5kg/m2l and a total body weight of between 50 and 100kg inclusive.
* Evidence of a personally signed and dated informed consent document indicating that the subject (or a legally acceptable representative) has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

* Evidence or history of clinically significant haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, genitourinary, psychiatric, neurologic or allergic disease (including drug allergies, but excluding untreated, symptomatic, seasonal allergies at time of dosing)
* History of febrile illness within 5 days prior to the first dose a positive urine drug screen
Cerebral Function Monitoring in Premature Infants

This observational study tests the feasibility of enrolling subjects and obtaining an amplitude-integrated electroencephalogram (aEEG) within the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks post-menstrual age. It will enroll 85-100 infants between 401-1,000 grams birth weight OR between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal Research Network sites.

Few techniques exist to permit early and accurate prognosis of brain injury in newborns. Cranial ultrasound and magnetic resonance imaging (MRI) have been used to detect structural abnormalities which may be useful in predicting neuromotor and neurocognitive deficits. However, up to 30% of extremely low birth weight infants with normal ultrasounds have adverse outcomes, and MRI is not feasible when an infant is critically ill. Amplitude-integrated electroencephalogram (aEEG) is a non-invasive, bedside instrument which allows real-time monitoring of brain function and may provide additional information for predicting outcomes in extremely premature infants.

This observational study will enroll 85-100 infants between 401-1,000 grams birth weight OR between 23 0/7 and 28 6/7 weeks gestational age born at the 7 participating NICHD Neonatal Research Network sites. Eligible infants will undergo an aEEG recording in the first 72 hours of life, a second aEEG recording between 72-168 hours of life, and weekly thereafter up to 36 weeks post-menstrual age.

The study tests the feasibility of enrolling subjects and obtaining the required aEEG recordings. The information gathered will provide a framework for the design of a potential prospective, observational, multi-center study for prediction of death or neurodevelopmental impairment by 18-22 months of age.

Eligibility Criteria:
Inclusion Criteria:

* Inborn infants
* Between 401 grams and 1,000 grams inclusive birth weight OR between 23 0/7 and 28 6/7 weeks inclusive gestational age
* Decision to provide full intensive care support
* Less than 72 hours of age

Exclusion Criteria:

* Non-intact skin at the central or parietal regions of scalp
* Presence of known or suspected congenital anomalies, including:
* Congenital central nervous system malformations
* Chromosomal anomalies or multiple congenital anomalies
* Complex congenital heart disease
* Inborn error of metabolism
* Acidosis (pH \< 6.8 for \> 2 hours)
* Persistent bradycardia \[HR \< 100 bpm\] associated with hypoxia for \> 2 hours
A Study of XSTEM-VLU in Patients With Difficult-to-heal Venous Leg Ulcers

The aim of the study is to assess safety, tolerability and preliminary efficacy of XSTEM-VLU when administered as a single topical dose to patients with difficult-to-heal venous leg ulcers. The study is randomised and the patients will receive either XSTEM-VLU or vehicle as add on to standard wound care.

The patients will be followed weekly for 10 weeks after treatment. At 4 months after treatment, the patients will return to the clinic for an end-of-study visit.


Eligibility Criteria:
Major Inclusion Criteria:

* Written informed consent for participation in the study
* Male or female patient aged ≥18 years
* BMI ≥18.5 and ≥40.0 kg/m2
* Lower leg wound due to venous insufficiency
* Target wound has failed to heal despite standard wound care for a minimum of 6 weeks
* A surface area of the target wound of ≥2 and ≤40 cm2

Major Exclusion Criteria:

* Signs or symptoms of clinically significant ongoing infection i the target wound requiring anti-microbial treatment
* History of autoimmune disease, such as but not limited to systemic lupus erythematosus, Addison's disease, Crohn's disease and type I diabetes mellitus
* B-HbA1C value ≥52 mmol/mol
* Plaque psoriasis or any other skin disease that could interfere with the outcome of the study
* Arterial insufficiency
* History of any malignancy within the past 5 years
* Target wound diagnosed as a malignant wound, neuropathic wound, pressure wound or osteomyelitis
* Patients who are immunocompromised due to disease or for other reasons such as the use of systemic immunosuppressants
Electromyographic Analysis of Scapular Muscles During Closed Kinetic Chain Exercises

In shoulder rehabilitation, the inclusion of kinetic chain exercises is advocated in order to provide the necessary energy transfer to produce optimal force with minimal energy consumption. Closed kinetic chain (CKC) exercises are defined as exercises in which the distal segment is stabilized by encountering significant resistance while the proximal segment moves. In contrast, open kinetic chain (OKC) exercises allow the distal segment to move freely without any resistance. Recently, the importance of closed kinetic chain (CKC) exercises has increased in enhancing shoulder joint neuromuscular control by improving dynamic shoulder stability and joint position sense.

The most current shoulder rehabilitation protocols include exercises for restoration of scapular muscle imbalances.There exist studies investigating the levels of scapular muscle activation during CKC exercises. Researchers have shown that most CKC exercises especially push-ups and plank variations with the shoulder in the 90° position, generally provide high SA activity and an optimal UT/SA ratio.In the literature, there is limited information on how the level of shoulder elevation affects scapular muscle activity and ratio during closed kinetic chain exercises in the prone position. To effectively prescribe CKC exercises commonly used in rehabilitation and athletic programs, a clear understanding of shoulder elevation changes muscle activity during these exercises is required.

Our hypothesis is that glenohumeral joint elevation status will alter scapular muscle activation and activation rates.

Twenty-two healthy male individuals to recruited in the study. Conducting a power analysis through G∗Power, considering a moderate effect size (f = 0.25), an alpha level of 0.05, and a power of 0.8. The outcome of this analysis indicated a required minimum sample size of 21 individuals. This study was used a randomized, repeated measures cross-over design. Muscle activation levels during maximum voluntary isometric contraction (MVIC) of each muscle (Upper trapezius, Middle trapezius, Lower trapezius, Serratus anterior) will be recorded to normalize muscle activation levels during closed kinetic chain exercises. Muscle activation levels will be evaluated with a surface electromyography device (Noraxon, Myomotion, USA).

Eligibility Criteria:
Inclusion Criteria:

* Physically active male individuals (self-reported participating in 150 minutes per week of moderate-vigorous aerobic activity)
* Being between 18-30 years old
* Having full range of motion of shoulder without pain
* Having a body mass index less than 30 kg\\m2.

Exclusion Criteria:

* Having pain in any kinetic chain of the body, had history of any musculoskeletal problems or orthopaedic surgery,
* Having symptoms in at least one of the screening tests (Hawkins-Kennedy, Neer, Resistant External Rotation, Jobe and Apprehension Test),
* Being diagnosed with a rheumatic, systemic or neurological disease.