cyrilzakka/clinical-trials huggingface dataset:
Non-alcoholic Fatty Liver Disease in Low Birth Weight Individuals

The investigators will conduct a proof-of-principle deep phenotyping 4-weeks caloric restriction intervention study in low birth weight (LBW) subjects with NAFLD and normal birth weight (NBW) controls. Furthermore, the investigators will provide extended in-depth mechanistic insight into the role of impaired subcutaneous adipose tissue (SAT) expandability in ectopic fat deposition in LBW subjects in LBW individuals with and without NAFLD.

An adverse fetal environment characterized by low birth weight (LBW) plays a key role in the development of type 2 diabetes (T2D). The investigators recently demonstrated a 3-fold increase in liver fat in 26 early middle-aged LBW compared to 22 normal birth weight (NBW) men, and 20% of the LBW - but none of the normal birth weight (NBW) - men had previously unknown non-alcoholic fatty liver disease (NAFLD). The investigators hypothesize that ectopic fat deposition and NAFLD is among the earliest disease manifestations and on the critical path to the development of more severe cardiometabolic disease in LBW. The investigators furthermore hypothesize, that LBW individuals exhibit ectopic liver fat due to reduced capacity to store fat in the subcutaneous adipose tissue (SAT) depot, and that early detection and subsequent intensive caloric restriction, in middle-aged LBW individuals with overt NAFLD, may represent a targeted and highly efficient way forward to prevent more severe cardiometabolic disease manifestations in LBW subjects. To further explore the recent findings, the investigators aim to perform an extended nested case-control screening study for NAFLD in 250 early middle-aged non-obese LBW men and women, and subsequently to conduct a deep-phenotyping, proof-of-principle 4 week time-restricted eating (TRE) intervention study in 12 LBW subjects with NAFLD including measures of hepatic fat content, glucose, insulin and lipid metabolism, as well as 24h metabolic profiles using respiratory chambers. Finally, the investigators will provide extended in-depth mechanistic insight into transcriptional, epigenetic as well as functional SAT and preadipocyte perturbations underlying impaired SAT expandability in LBW individuals with and without NAFLD and NBW controls studied before and after different dietary interventions including TRE and high carbohydrate overfeeding.

Eligibility Criteria:
Inclusion Criteria:

* LBW subjects with NAFLD (liver fat content ≥5% liver fat content verified on MRS)
* Gender- and body mass index-matched NBW controls without NAFLD
* Born at term (weeks 39-41)

Exclusion Criteria:

* BMI\<18.5 and BMI\>30 kg/m2
* Family history of diabetes (siblings, parent, and grandparents)
* Disease/medication known to affect primary outcome
* Self-reported high physical activity level
* Alcohol intake above general recommendations.
* Metabolic/liver disease
* Weight gain/loss of \>3 kg within the past 6 months
Pemafibrate to Reduce Cardiovascular OutcoMes by Reducing Triglycerides IN patiENts With diabeTes (PROMINENT)

The primary objective of the study is to determine whether pemafibrate administered twice daily will delay the time to first occurrence of any component of the clinical composite endpoint of:

* nonfatal Myocardial Infarction (MI)
* nonfatal ischemic stroke
* coronary revascularization; or
* Cardio Vascular (CV) death.

A multi-regional clinical trial with participating sites in the following countries. India is being conducted under a previous protocol version due to regulatory requirements.

* Argentina
* Brazil
* Bulgaria
* Canada
* Colombia
* Czech Republic
* Denmark
* France
* Germany
* Hungary
* India
* Israel
* Japan
* Mexico
* Netherlands
* Poland
* Romania
* Russian Federation
* Slovakia
* South Africa
* Spain
* Ukraine
* United Kingdom
* United States

Eligibility Criteria:
Inclusion Criteria:

1. Fasting TG ≥ 200 mg/dL (2.26 mmol/L) and \< 500 mg/dL (5.65 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
2. HDL-C ≤ 40 mg/dL (1.03 mmol/L) at Visit 1 (Screening/Enrollment Visit) or Visit 1.1 (Retest)
3. Type 2 diabetes of longer than 12 weeks duration documented in medical records, for example: local laboratory evidence through medical record review of elevated HbA1c (≥ 6.5% \[48 mmol/mol\]), elevated plasma glucose (fasting ≥ 126 mg/dL \[7.0 mmol/L\], 2-hour ≥ 200 mg/dL \[11.1 mmol/L\] during oral glucose tolerance testing, or random value ≥ 200 mg/dL with classic symptoms, or currently taking medication for treatment of diabetes; AND either

   1. Age ≥ 50 years if male or ≥ 55 years if female (primary prevention cohort); OR
   2. Age ≥ 18 years and established systemic atherosclerosis (secondary prevention cohort), defined as any 1 of the following:

      * i. Prior MI or ischemic (non-hemorrhagic) stroke
      * ii. Coronary angiographic lesion of ≥ 60% stenosis in a major epicardial vessel or ≥ 50% left main stenosis
      * iii. Asymptomatic carotid disease with ≥ 70% carotid artery stenosis
      * iv. Symptomatic carotid disease with ≥ 50% carotid artery stenosis
      * v. Symptomatic lower extremity PAD (ie, intermittent claudication, rest pain, lower extremity ischemic ulceration, or major amputation with either ankle-brachial index ≤ 0.9 or other diagnostic testing \[eg, toe-brachial index, angiogram, or other imaging study\])
      * vi. Prior arterial revascularization procedure (including coronary, carotid, or peripheral angioplasty/stenting, bypass, or atherectomy/endarterectomy)

Exclusion Criteria:

1. Current or planned use of fibrates or agents with PPAR-α agonist activity (eg, saroglitazar) within 6 weeks (42 days) of Visit 1 (Screening/Enrollment Visit). Note: PPAR-γ agonists (eg, glizatones such as pioglitazone and rosiglitazone) are allowed
2. Known sensitivity to PPAR-α agonists or tablet excipients
3. Initiation of, or change in, current TG-lowering therapy within 12 weeks of Visit 1 (if applicable). Note: TG-lowering therapy is defined as niacin \> 100 mg/day or dietary supplements or prescription omega-3 fatty acids \> 1 g/day
4. Type 1 diabetes mellitus
High Flow Nasal Cannula Oxygen During Sedation for Video-assisted Thoracoscopic Surgery

High-flow nasal cannula (HFNC) is a device that delivers10 to 70 L min-1 of heated, humidified 100% oxygen via nasal route. It provides positive airway pressure, decreases dyspnea, decreases the work of breathing, and improves comfort

Beneficial effects of the HFNC system have been assessed based on 3 physiologic conditions: decreased dead space, a high concentration of inspiratory oxygen, and positive pressure in the oro-laryngeal cavity.Studies have shown that it improves oxygenation in various perioperative settings such as the apneic patients, patients with respiratory failure , and patients undergoing bronchoscopy

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status II and III,
* undergoing VATS

Exclusion Criteria:

* refusal of patients
* extrem of age
Half-normal Saline in Atrial Fibrillation Ablation

The study evaluates the use of half-normal saline as an irrigant for open-irrigated catheters during atrial fibrillation ablation. By increasing the efficacy of radiofrequency energy-mediated lesion formation, half-normal saline has the potential to reduce procedural times and improved acute and long-term outcomes.


Eligibility Criteria:
Inclusion criteria

* male or female between 18 and 75 years of age at the time of enrollment
* undergoing first-time radiofrequency ablation for atrial fibrillation
* written informed consent obtained from subject or subject's legal representative and ability for subject to comply with the requirements of the study

Exclusion criteria

* robotic-guided atrial fibrillation ablation
* baseline hyponatremia (serum sodium level \< 135 mEq/L)
* pregnant, breastfeeding, or unwilling to practice birth control during participation in the study
* presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data
Probiotics as Adjunct to Nonsurgical Periodontal Treatment

ProlacSan probiotic lozenges and gels contain L. plantarum and L. brevis strains with proven in vitro antimicrobial activity against P. gingivalis. In our study we aim to investigate proposed benefit of ProlacSan as adjunct to conventional initial periodontal treatment in a group (n = 40) of Grade III and IV periodontitis patients. Patients will be randomized in two groups receiving either probiotic (n = 20) or placebo (n = 20) after completion of nonsurgical treatment within 7 days. Before treatment and after three months, standard periodontal parameters will be measured by masked examiner and plaque samples harvested for cultivation of 9 most relevant periodontal pathogens. One lozenge per day of probiotic/placebo will be used during 3 months healing period. Primary outcome measures will be the number of persisting sites per patient that need additional surgical treatment defined as sites with probing depth \> 4 mm and bleeding on probing.


Eligibility Criteria:
Inclusion Criteria:

* periodontitis stage III or IV
* at least 20 teeth for evaluation
* besides solitary crowns, no other prosthodontic tooth replacements
* good systemic health
* smoking less than 10 cig/day

Exclusion Criteria:

* periodontal treatment lass than 1 year before inclusion
* antibiotic therapy in the last 6 months
* chronic systemic diseases with the impact on periodontium or healing process
* medication with the impact on periodontium or healing process
The Effect of Vibration Applied on Forearm Extensor Muscles Patients With Stroke

This study was planned to determine the effect of vibration applied to forearm extensor muscles on hand functions and muscle activation in stroke patients.

Patients will be included in our study, who will be hospitalized in Kirikkale University Faculty of Medicine Physical Therapy Hospital and will receive stroke rehabilitation. The number of patients will be determined to be approximately 24 according to the power analysis. Patients meeting the inclusion criteria and excluding the exclusion criteria will be randomized according to the order of arrival and divided into 2 groups as the training group and the control group. Patients will be randomized using block randomization. Routine conventional physical therapy will be applied to the patients in the vibration group in 4 weeks and 45 minutes sessions. In addition, 30 Hz, 3 days a week, immediately after the sessions, to the forearm extensor group muscles with ''Conformité Européene'' certified vibration device. frequency vibration will be applied. A vibration session will be as follows; 6 sets of vibrations will be applied, including 1 set of 1 minute vibration and 2 minutes of rest. Routine conventional physical therapy will be applied to the control group in 4 weeks and 45 minute sessions.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with stroke
* Cognitive and without communication problems
* Patients with active movement in the upper extremities

Exclusion Criteria:

* People who have undergone botulinum toxin application to the upper extremity
* Significant cognitive impairment that will interfere with functional evaluation
* Deformity and / or contracture in the upper extremity due to fractures, inflammatory arthropathy, etc.
* Infection, skin lesion or hematoma at the application site
Evaluation of the Use of the Renuvion APR System in the Labia

Labiaplasty is a procedure aimed at reducing lax or loose skin in the labia majora and/or minora due to childbirth, trauma, aging, genetics, or congenital disease.

While traditional surgical procedures have been associated with complications such as dehiscence, hematoma, flap necrosis, narrowed introitus, and pain and asymmetry, correction with RF energy has shown minimal complication rates with high patient satisfaction. This study aims to evaluate the use of the Renuvion APR System for use as a minimally invasive alternative to surgical labiaplasty.

Eligibility Criteria:
Inclusion Criteria:

* Female subjects, ages 35 - 70 years old.
* ASA Physical Status Classification System Class I and Class II subjects.
* Labial protrusion Class II and Class III (MOTAKEF scale)12.
* Females who do not desire traditional invasive surgery.
* Understands and accepts the obligation not to undergo any other procedures or treatments in the areas to be treated during study participation.
* Absence of physical conditions unacceptable to the investigator.
* Females of childbearing potential who are sexually active must be willing to use an approved method of birth control during study participation.
* Willing and able to comply with protocol requirements, including study-required images/photos, assessments/measurements, and returning for follow-up visits.
* Willing to release rights for the use of study photos, including in publication.
* Able to read, understand, sign, and date the informed consent.

Exclusion Criteria:

* Labial protrusion Class I (MOTAKEF scale).
* Subjects presenting with ASA Physical Status Classification System Classes III or higher.
* Pregnant, lactating, or plans to become pregnant during study participation.
* Known hypersensitivity or allergy to tumescent anesthetic (lidocaine/ epinephrine).
* Previous treatment in the study treatment area.
* Active systemic or local skin disease that may alter wound healing.
* Significant or uncontrolled medical condition that in the opinion of the investigator participation in the study may compromise the patient's health.
* Known susceptibility to keloid formation or hypertrophic scarring.
* Cancerous or pre-cancerous lesions in the area to be treated.
* Possesses a surgically implanted electronic device (i.e., pacemaker).
* Serious mental health illness such as dementia or schizophrenia; psychiatric hospitalization in the past two years.
* Participation in any other investigational study within 30 days prior to consent and throughout study participation.
* Subject who, in the opinion of the investigator, is not an appropriate candidate for the study.
MRI in Patients With Kennedy Disease

Kennedy disease is an inherited neuromuscular disorder that is characterized by progressive muscle wasting and weakness. It typically starts with muscle spasms and tremors in the arms, followed by muscle weakness and atrophy of muscles in the arms and legs. The facial and bulbar muscles are also involved. However, the muscle involvement pattern has not been investigated systemically in Kennedy disease.

The primary aim of the study is to investigate the muscle involvement in patients with Kennedy disease using MRI. Secondary aims are to examine disease severity and to test MRI as a potential outcome measure for future clinical trials in Kennedy disease.

Approximately 40 patients with Kennedy disease and 20 gender and age matched healthy voluntary controls will be recruited. The study consists of one visit per subject lasting 4-5 hours.


Eligibility Criteria:
Patients with Kennedy disease:

Inclusion Criteria:

* Confirmed Kennedy disease

Exclusion Criteria:

* All contraindications for undergoing an MRI scan

Healthy controls

Inclusion Criteria:

* Fit age and gender criteria

Exclusion Criteria:

* All contraindications for undergoing an MRI scan
The Effect of Permissive Hypercapnia on Oxygenation and Post-operative Pulmonary Complication During One-lung Ventilation

Permissive hypercapnia increased the survival rate in patients with acute respiratory distress syndrome (ARDS) who required mechanical ventilation in critical care medicine. This has been explained by its association with ventilator induced lung injury. Since then, a protective lung ventilation strategy has been very important, with a low tidal volume of 4-6 ml/kg. Patients undergoing surgery will inevitably require mechanical ventilation. In particular, patients undergoing one lung ventilation for thoracic surgery may have increased airway pressure and a greater chance of ventilator induced lung injury. Recently, protective lung ventilation has been applied to patients undergoing one ung ventilation during thoracic surgery. The purpose of this study is to evaluate the difference in the degree of pulmonary oxygenation and the incidence of postoperative pulmonary complications in hypercapnia induced by controlling the respiratory rate with a constant tidal volume.


Eligibility Criteria:
Inclusion Criteria:

1. Adult patients aged 40-80 years who are planning to have thoracoscopic single lobectomy or segmentectomy with one lung ventilation during surgery.
2. American Society of Anesthesiologists (ASA) classification 1\~3

Exclusion Criteria:

1. patients with heart failure (NYHA class III\~IV)
2. patients who are having moderate obstructive lung disease or restrictive lung disease
3. Low DLCO (\< 75%)
4. patients with brain disease history or increased ICP
5. patients with pulmonary hypertension (mean PAP\>25mmHg)
6. patients with liver disease (AST level ≥100 IU/mL or ALT ≥ level 50 IU/L) or kidney disease (Creatine level ≥ 1.5 mg/dL)
7. patients with pre-existing hypercapnia or metabolic acidosis
8. body mass index (BMI) \> 30 kg/m2
9. patients who have had contralateral lung surgery
10. patients who cannot read explanation and consent form
11. patients who are pregnant
Protective Cooling Measures to Safeguard Elderly People From Dangerous Summer Heat

With the increasing incidence and severity of extreme heat events accompanying climate change, there is an urgent need for sustainable cooling strategies to protect heat-vulnerable older adults, who are at increased risk of adverse health events during heat stress. Health agencies including the World Health Organization, the United States Centers for Disease Control and Prevention, and Health Canada currently recommend visiting a cooling centre or other air-conditioned location for 1-3 hours per day during extreme heat events to mitigate hyperthermia and strain on the cardiovascular system and therefore the risk adverse health events. However, our recent trial shows that while brief air-conditioning exposure is effective for reducing body temperature and cardiovascular burden in healthy older adults, the physiological impacts of cooling abate quickly following return to the heat. The purpose of this project is therefore to assess whether shorter but more frequent air-conditioning exposure provides more effective cooling than current recommendations (a single 1-3-hour cooling bout) in older adults with or without common chronic health conditions associated with increased vulnerability to extreme heat. This will be accomplished by evaluating physiological strain in older adults with and without diabetes and/or hypertension exposed for 8 hours to conditions reflective of extreme heat events in temperate, continental climates (35°C, 60% relative humidity). Participants will complete 3 separate simulated heat event exposures: i) a control trial (no cooling throughout the 8-hour heat event); ii) a recommended cooling trial (3 hours of heat exposure followed by 2 hours cooling); and iii) a hybrid cooling trial (2 hours of heat exposure followed by 1 hour cooling, another 2 hours heat exposure followed by 1 hour cooling, and a final 2-hour heat exposure).


Eligibility Criteria:
Inclusion Criteria:

* Adult aged 60-85 years
* Male or female
* Body mass index \< 35 kg/m2
* For participants with type 2 diabetes: at least one year lapsed since diagnosis and hemoglobin A1c 6.0-10.5%.
* For participants with hypertension: at least one year lapsed since diagnosis or average resting blood pressure \>140 systolic or \>90 diastolic

Exclusion Criteria:

* Currently smoking or quit \<5 years ago
* Moderate or serious medical conditions (other than Type 2 diabetes or high blood pressure), particularly those known to influence physiological responses to heat exposure (e.g., diagnosed heart disease, neurological disorders)
* Heat adapted due to repeated exposure to hot environments (use sauna, recent travel to hot climates, other)
* For participants with type 2 diabetes: "Brittle" diabetes: unpredictable hypo- \& hyperglycemia. Severe cardiovascular autonomic or peripheral neuropathy (guidelines.diabetes.ca/cpg)
Tailored Communication to Reduce Cardiovascular Risk

The primary goal of the trial is to test the feasibility and efficacy of a cardiovascular disease quality improvement system that couples EMR-based patient identification with individually tailored patient messages. The study will test the hypothesis that that a tailored patient-directed approach to cardiovascular risk reduction integrated into patients' primary care delivery site will improve control of elevated low-density lipoprotein cholesterol and other card iac risk factors more than routine care alone for patients at intermediate or high risk for cardiovascular disease.


Eligibility Criteria:
Inclusion Criteria:

* Age 40 to 79 years
* medication list does not include an active lipid lowering medication
* the patient does not have a diagnosis in the past medical history, active problem list or past visit encounter of coronary heart disease, heart failure, stroke, diabetes mellitus, or peripheral arterial disease
* the patient has an enrolled study physician recorded as his/her primary care physician
* the patient has an LDL cholesterol that meets one or more of the criteria listed below.

LDL cholesterol \>= 130 mg/dl and estimated Framingham Risk Score 10-20% LDL cholesterol \>= 100 mg/dl and estimated Framingham Risk Score \>20% LDL cholesterol \>= 160 mg/dl and estimated Framingham Risk Score 5% to \<10%.

Exclusion Criteria:

* Age \<40 or \>79 years
* medication list includes an active lipid lowering medication
* the patient hase a diagnosis in the past medical history, active problem list or past visit encounter of coronary heart disease, heart failure, stroke, diabetes mellitus, or peripheral arterial disease
* the patient does not have an enrolled study physician recorded as his/her primary care physician
* the patient does not have an LDL cholesterol that meets one or more of the criteria listed below.

LDL cholesterol \>= 130 mg/dl and estimated Framingham Risk Score 10-20% LDL cholesterol \>= 100 mg/dl and estimated Framingham Risk Score \>20% LDL cholesterol \>= 160 mg/dl and estimated Framingham Risk Score 5% to \<10%.