cyrilzakka/clinical-trials huggingface dataset:
Effects of Home-based Exercise Rehabilitation on Healthcare Utilization in HeartMate 3 Patients

To demonstrate that home-based exercise rehabilitation (HER) compared to usual care (UC) results in a significant reduction in healthcare utilization in HeartMate 3 (HM3) left ventricular assist device (LVAD) patients.(defined as rehospitalization, VAD Clinic visits, and ER visits during the 1st year after index discharge following LVAD implantation).

HER Subjects:

Get Garmin activity watch (has its own smartphone app to be activated)\*, Datos app Get resistance bands and light weights Exercise prescription: Initially by physical therapist prior to discharge home \& updated every month.

UC Subjects:

Get Garmin activity watch (has its own smartphone app to be activated), Datos app Exercise prescription: Try to get to 30 min of exercise 5 days a week

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age on the date of randomization
* Patient implanted with a new HeartMate 3 LVAD at URMC
* Patients enrolling in the study at the time of index discharge home following new HM3 LVAD implantation will be evaluated by a HF cardiologist and physical therapist and will need to demonstrate ability to ambulate independently. Patients enrolling in the study after their index discharge home following HM3 LVAD implantation will be evaluated by a HF cardiologist or VAD Coordinator and will need to demonstrate ability to ambulate independently.
* Patient willing to participate in HER.
* Patient owns a smartphone with Internet connection.

Exclusion Criteria:

* Major comorbidities or limitations that may interfere with exercise training (including significant orthopedic/neurologic limitations, decompensated HF, uncontrolled arrhythmias, unstable angina).
* Patient with a life expectancy \<12 months.
* Patient unwilling to sign the consent for participation.
* Patient unwilling or unable to cooperate with the study protocol
* Patient who does not anticipate being a resident of the area for the scheduled duration of the research study
* Pregnancy
The Relationship Between Increasing Loading and Kinematic Parameters

The aim of this study is to investigate the influence of increasing loading to kinematic parameters of normal people while walking on the treadmill.


Eligibility Criteria:
Inclusion Criteria:

1. 20\< age \< 30.
2. Body mass index \< 30.
3. No history of major injury or surgery in lower limbs.
4. No symptoms of lower limbs.
5. Physical examination to test the lower limbs to be normal.
6. The habit of moderate exercise (e.g. Jogging) at least once a week for at least 30 minutes.

Exclusion Criteria:

1. Body mass index \>30.
2. Injury or surgery in hip/knee/ankle.
3. History trauma in the lower limbs (e.g. fracture).
4. Neuropathic disease.
5. Muscular disease.
6. Lack ability to finish the procedure physically or mentally.
7. Easy to fall.
8. Any other conditions that can influence gait parameters of the lower limbs.
Diet Oil Induced Stimulation of GLP-1

Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals containing of olive oil or carbohydrates alone.

Activation of G protein-coupled receptor GPR119 stimulates glucagon-like peptide-1 (GLP-1)release from the intestinal L-cells. Previously, administration of 2-oleyl-glycerol (2-OG) to humans significantly increased plasma GLP-1. In the present study we want to test the effect in patients with type 2 diabetes. The hypothesis is that we will expect to find a significant increased plasma GLP-1 following a meal containing of 2-OG when compared to meals containing of olive oil or carbohydrates alone. The aim of the study is to elucidate the effect of 2-OG, 'diet oil' on GLP-1 secretion in patients with type 2 diabetes and to explain the mechanism behind the known stimulation of GLP-1 release by dietary fat.

Eligibility Criteria:
Inclusion Criteria:

* Patients with type 2 diabetes mellitus according to the WHO criteria
* caucasians
* age above 18 years
* BMI 20-30

Exclusion Criteria:

* kidney disease
* liver disease
* retinopathy
* anaemia
* use of insulin
* use of GLP-1 analogues
* use of DPP-4 inhibitors
Continuous Fascia Iliaca Compartment Block in Geriatric Hip Fracture

The patient with hip fracture who has Numerical Rating Scale (NRS) ≥ 5 at rest or on movement will be indicated for USG FICB at Emergency Department or patient's ward.

The aim of this prospective observation study was evaluated the efficacy and complications of cFICB in adult hip fracture preoperatively.

The Enhance Recovery Program of pain management in geriatric hip fracture has been set up as a part of fast track at Siriraj Hospital since September 2017. The ultrasound-guided (USG) fascia iliaca compartment block (FICB) is routinely offered to patients with a hip fracture by acute pain service (APS) anesthesiologist. The patient with hip fracture who has Numerical Rating Scale (NRS) ≥ 5 at rest or on movement will be indicated for USG FICB.

The aim of this prospective observation study was evaluated the efficacy and complications of cFICB in adult hip fracture preoperatively.

Eligibility Criteria:
Inclusion Criteria:

* patient age equal or more than 65 years old
* patient with acute hip fracture within 7 days
* patient with NRS ≥ 5

Exclusion Criteria:

* patient refusal
* history of local anesthetic allergy
* inability to communicate or cognitive dysfunction
* multiple fracture involvement
Does Human Skeletal Muscle Possess an Epigenetic Memory of Testosterone?

This project's primary aim of this double-blinded, randomised, placebo-controlled trial is to investigate whether short-term testosterone administration +/- resistance exercise training induces a muscle memory response that can lead to longer-lasting benefits in aged human skeletal muscle.

The investigators will provide older men with the anabolic hormone, testosterone or placebo, with or without resistance training, followed by a period of testosterone abstinence and detraining, followed by a subsequent repeated period of resistance training (retraining). This will help determine if earlier encounters with short-term testosterone administration can be "remembered" and if adaptation to later retraining can be enhanced as a consequence of encountering testosterone earlier.


Eligibility Criteria:
Inclusion Criteria:

* Sedentary males
* 55-70 years old
* Serum testosterone levels \>8 nmol/L measured in the morning
* Without any known illness, disease or other conditions
* Undergone screening through medical questionnaire, physical examination, routine blood tests and urine sample
* Written informed consent received

Exclusion Criteria:

* Current or previous participation in a formal exercise regime
* A BMI \< 18 or \> 30 kg·m2
* Hypersensitivity to the study drug or to any of its constituents
* Active cardiovascular disease: uncontrolled hypertension (BP \> 160/100 mmHg), angina, heart failure (class III/IV), arrhythmia, right to left cardiac shunt, recent cardiac event
* Family history of early (\<55y) death from cardiovascular disease
* Haematocrit \>50%
* Malignancy
* Prostate-specific antigen (PSA) \>4 ng/mL
* Lower urinary tract symptoms
* Taking beta-adrenergic blocking agents, statins, non-steroidal anti-inflammatory drugs
* Cerebrovascular disease: previous stroke, aneurysm (large vessel or intracranial), epilepsy
* Respiratory diseases including: pulmonary hypertension, chronic obstructive pulmanary disease (COPD), asthma, sleep apnoea
* Metabolic disease: hyper and hypo parathyroidism, untreated hyper and hypothyroidism, Cushing's disease, type 1 or 2 diabetes
* Active inflammatory bowel or renal disease
* Current or previous steroid treatment or hormone replacement therapy
* Clotting dysfunction
* Musculoskeletal or neurological disorders
* Alcohol or drug abuse
* Receiving oral anticoagulants
* Serum testosterone levels above the reference range for 50 year olds (\>32 nmol/L) (Bjerner et al., 2009) measured in the morning 1
Post Tonsillectomy Analgesia Comparison After Surgery Site Spray of Local Anesthesics

Check analgesia after tonsillectomy in adults

We hypothesize that a vaporization of local anesthetics in the tonsil lodge would reduce postoperative pain.

Eligibility Criteria:
Inclusion Criteria:

* Tonsillectomy

Exclusion Criteria:

* Gastric or duodenal ulcer
* Diabetes
* Kidney failure
* Chronic pain and fibromyalgia
CD-ROM Intervention for Prostate Cancer Screening

The study populations consist of a sample of the patient population (men aged 40-79 years) of a large, group model HMO and a community sample of men age 50-79. Follow-up interviews of men randomly assigned to the intervention and control groups are being conducted by telephone to assess issues related to prostate cancer screening and the men's use of the CD-Rom educational intervention.

The study populations consist of a sample of the patient population (men aged 40-79 years) of a large, group model HMO and a community sample of men age 50-79. Follow-up interviews of men randomly assigned to the intervention and control groups are being conducted by telephone to assess issues related to prostate cancer screening and the men's use of the CD-Rom educational intervention. Preliminary results are available for the first 1304 follow-up interviews (interim response rate = 26%). Of 554 men randomized to receive the CD-ROM, 227 (41%) reported receiving the CD-ROM, and 78 (14%) used it in a computer. About 51% of these 78 men used the CD-ROM once only, while 42% used it twice, and 27% shared it with someone else. Most users reported learning some (44%) or a great deal (46%) of new information from the CD-ROM, and most reported that it helped them organize their thoughts about screening somewhat (44%) or a great deal (28%). About 19% indicated that the CD-ROM increased their uncertainty somewhat or a great deal about whether or not they want to be screened, 30% reported that the CD-ROM changed their feelings about whether or not they want to be screened somewhat, and 12% reported that it changed their feelings a great deal. Men who used the CD-ROM had higher education, higher income, higher levels of computer usage, and were more likely to have previously had a PSA test compared to non-users. No other subject characteristics were significantly related to use. Using randomized group assignment in an "intention to treat" analysis, prostate cancer knowledge was significantly higher in the intervention group; there were no differences between study groups in decisional conflict or realistic expectations. However, when comparing those who did and did not use the CD-ROM using multiple regression analysis and controlling for differences in age, race, education, income, insurance status, previous receipt of prostate cancer screening, and computer usage, use of the CD-ROM was significantly associated with higher prostate cancer related knowledge, lower decisional conflict, and more realistic expectations about risk of dying from prostate cancer. After controlling for differences between users and non-users we found evidence that the CD-ROM was effective in reducing decisional conflict, and increasing knowledge and realistic expectations related to prostate cancer screening.

Eligibility Criteria:
Inclusion Criteria:

-

Exclusion Criteria:

* prostate cancer
Effect of Infant Formulas Containing a New Fat Blend or the New Fat Blend Plus Fiber in Healthy Term Infants

* The primary objective of the study was to compare stool composition (stool soap and non-soap fatty acids, total fatty acids, minerals, and other stool constituents) of infants randomized to receive either standard formula, or 1 of 2 innovative formulas containing a new fat blend or the new fat blend plus fiber.
* The secondary objectives were to evaluate among the feeding groups, stool characteristics (stool consistency and frequency), GI tolerance assessed by the Infant Gastrointestinal Symptom Questionnaire (IGSQ), and urinary markers (F2-isoprostanes and 8-hydroxy-2'-deoxyguanosine \[8-OHdG\], and urine osmolality and specific gravity).
* The primary safety objective was to describe the frequency of adverse events (AEs) among the formula-fed (FF) groups.
* The secondary safety objective was to describe anthropometric measures (weight, length, and head circumference) among the feeding groups.


Eligibility Criteria:
Inclusion Criteria:

* Healthy, term (no less than 37 weeks and no greater than 42 weeks) singleton infants; between 25 days to 45 days post natal age (date of birth = Day 0) and weight for age ≥3rd and ≤97th percentiles according to Taiwan growth charts at the time of study entry.
* Human milk fed infants were exclusively consuming and tolerating HM and the mother must have made the decision to continue to exclusively breastfeed.
* Formula-fed infants were exclusively consuming and tolerating a cow's milk infant formula and parents/LAR must have previously made the decision to continue to exclusively formula feed.

Exclusion Criteria:

* Infants receiving any amount of supplemental HM with infant formula feeding or vice versa
* Family history of siblings with documented cow's milk protein intolerance/allergy
* Major congenital malformations, suspected or documented systemic or congenital infections, evidence systemic diseases
Type II Diabetes Influence on Left Ventricular Remodeling and Outcomes in Patients Undergoing Aortic Valve Replacement Surgery.

This project focuses on the physiopathology of left ventricular remodeling associated with type II diabetes in patients with aortic valve stenosis referred for surgical aortic valve replacement.

The main objective is to compare the reverse left ventricular remodeling between patients with type II diabetes and case-control patients without diabetes at one(1) year after surgical aortic valve replacement.

The secondary objectives are :

1. assess the influence of type II diabetes on left ventricular remodeling in patients presenting with aortic valve stenosis,
2. assess the predictive value of myocardial fibrosis and other LV characteristics present prior to aortic valve surgery on the LV reverse remodeling and their influence on cardiovascular events at one (1) year after surgery,
3. assess the influence of type II diabetes on cardiovascular morbidity and mortality post aortic valve surgery.

The investigators main hypothesis is that patients with type II diabetes and aortic valve stenosis requiring aortic valve replacement have poorer LV function and less favorable post surgery clinical outcomes than patients without type II diabetes.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Arm 1: Treated Type II diabetes, Arm 2: absence of type II diabetes
* Aortic valve stenosis
* LVEF \> 50% with no kinetic abnormalities
* Non significant obstructive coronary artery disease
* Absence of gadolinium enhanced MRI contraindications
* Informed consent signed
* Patient affiliated to the French Social Security.

Exclusion Criteria:

* Chronic arrhythmia or absence of sinus rhythm
* Past history of cardiomyopathy or coronary insufficiency
* Significant coronaropathy seen during the coronary angiography with \>50% degree stenosis prior to aortic valve replacement
* Hemodynamically significant valvular dysfunction other than aortic stenosis (grade 2 mitral or aortic insufficiency, mitral valve stenosis \< 1.5 cm2)
* Systemic chronic inflammatory disease leading to cardiac injury (scleroderma)
* Renal insufficiency (clearance \< 30 ml/min)
* Insufficient transthoracic echocardiography echogenicity
* Type I diabetes mellitus
* Uncontrolled hypertension (\> 180/100 mm Hg)
Predictors and Intervention for Noncompliance

This is a randomized controlled intervention trial in poorly compliant patients, testing whether improved compliance behavior decreases rates of acute rejection risk and graft loss.

Hypothesis: A study of an intensive intervention focused on the least compliant patients and beginning 3 months post-transplant. Effective intervention will reduce the number of acute rejection episodes and thus the occurrence of chronic rejection and graft loss.

Our original studies demonstrated "early" noncompliant behavior predicted adverse transplantation outcomes including acute graft rejection and graft loss. In this study, we are randomly assigning a telephone intervention in a prospective cohort of medically noncompliant patients. Standard therapy includes specifically warning patients about the risks of noncompliant behavior, and the formal intervention is randomized so half of these patients will also receive intensive telephone followup, intended to improve medication compliance and reduce adverse events.

Eligibility Criteria:
Inclusion Criteria:

* Kidney transplant
* Discharged from hospital with functioning graft

Exclusion Criteria:

* Risk of recurrent primary renal disease, e.g. hemolytic uremic syndrome, oxalosis, membranoproliferative glomerulonephritis type II, focal,segmental glomerulosclerosis with nephrotic syndrome
* Patients with active psychosis
* Patients not using azathioprine, sirolimus, or mycophenolate mofetil for immunosuppression at the time of discharge
* Patients taking the liquid form of azathioprine or mycophenolate mofetil
* Patients who are younger than 14 yrs. old
* Patients who do not speak English
* Receiving extra-renal organ except for pancreas,either simultaneously or previously
* Patients who live and will be followed outside of the United States, except Canada
* Patients who are physically unable to open the Medication Event Monitoring System(MEMS)cap
* Patients who are not responsible for taking their own medications, e.g. living in a medical care facility
Study of Early Infant Diet on Growth and Development

The purpose of this study is to characterize physical growth, body composition, dietary intake, neurobehavioral development, and brain function of infants and children fed mostly breast-milk, milk-based formula or soy-based formula during their first year of life. Children are followed from age 2 months to age 6 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Infants
* Birth weight = 6 to 9 lbs
* Mostly fed breast milk, milk-based formula, soy-based formula
* Mother over 18 years of age

Exclusion Criteria:

* Unhealthy pregnancy
* Illness during pregnancy or for the child that could interfere with the study parameters
The Effect of Dietary Fibre and Plant Protein on Appetite and Metabolic Function

Acute effects on appetite and metabolic function have been observed for whole-grain rye cereal products. The aim of this study is to evaluate if the appetite suppressing effect of a whole-grain rye breakfast cereal may be further enhanced by the addition of fermentable dietary fibre and plant protein. The aim is also to try to elucidate how observed effects on subjective appetite are mediated in terms of changes in hormonal signals, flow of nutrients in the blood and products from bacterial fermentation of dietary fibre, and to relate this to the different composition of the breakfasts.

The short-term effects (up to 8 hours after intake) of dietary fibre and plant protein on subjective appetite and metabolism will be evaluated using a randomized cross-over study design. Each participant will consume six different breakfasts on six different occasions separated by a 1 week wash-out period: three rye porridges supplemented with three different combinations of added fermentable dietary fibre and plant protein, two non-supplemented rye porridges differing in amount of rye and one wheat bread. Participants will rate subjective appetite (satiety, hunger and desire to eat) by using a visual analog scale (VAS) every 30 min during an 8-hour period, starting 30 min before breakfast. The concentration of hydrogen and methane in the breath, as indicators of bacterial fermentation of dietary fibre, will be measured every hour. Blood samples will be collected before breakfast and at regular intervals throughout the day for analysis of glucose and hormone levels. The metabolic profile in the blood will be assessed as well as products from bacterial fermentation of dietary fibre, such as short chain fatty acids. Gastric emptying rate will also be evaluated using paracetamol as an indicator. Hormonal responses, changes in the metabolome and fermentation products will be related to subjective appetite and to differences in composition of the breakfasts.

Eligibility Criteria:
Inclusion Criteria:

* Women must be post-menopausal or habitually take hormonal contraceptives
* Habitual breakfast eaters

Exclusion Criteria:

* Non-contraceptive use among pre-menopausal women
* Pregnancy, lactation or wishing to become pregnant during the study period
* Dieting
* Weightloss
* Eating disorder
* Hyperglycemic
* Hyperinsulinemic
* Thyroid disease
* Metabolic issues
* Diabetes
* Physical or psychological problems eating
* Food intolerances/allergies to foods included in the study
* Vegetarians
* Intolerance/allergy to paracetamol
* Heavy smokers
* Recent or concurrent participation in an intervention research study
The RolE of Prolonged Nightly faSTing to Improve Sleep and cOgnition in bREast Cancer Survivors

The investigators are interested in finding out how Prolonged Nightly Fasting (PNF) and/or health education may impact health and cancer recovery for breast cancer patients and survivors.

The purpose of this innovative, remotely-delivered pilot randomized controlled trial (RCT) is to explore the use of an 8-week prolonged nightly fasting (PNF) intervention, as compared to a Health Education-Only (HED-Only) control condition, among ethnically and racially diverse (≥50% Black, Hispanic, and/or Native American) breast cancer survivors (BCSs) with cancer-related cognitive impairment (CRCI) to examine changes in cognitive function, sleep, insomnia and health-related quality of life (i.e., mental and physical). Additionally, intervention feasibility will be assessed among the PNF participants. All participants will receive health education (HED) throughout. BCSs living with CRCI (N=60) will be recruited nationwide and randomized 1:1 into the PNF or HED-Only groups. Linear mixed models will be used to compare outcome changes in the PNF group compared to HED-Only group (Aims 1-3); descriptive and qualitative analyses will be used in the Exploratory Aim.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old
2. diagnosed with breast cancer (all stages included)
3. ≥3 months post neoadjuvant or adjuvant chemotherapy (maintenance or palliative systemic therapy is included)
4. score ≤30 or lower on the Patient Reported Outcome Measurement Information System Cognitive Function Short Form 8a (sr-CRCI)
5. able to speak/understand English
6. have access to a computer and Wi-Fi
7. live within the United States
8. Identifies as female
9. willing and able to fully participate in the study

Exclusion Criteria:

1. type 1 diabetes
2. actively enrolled in formal diet/weight loss program
3. previous bariatric surgery
4. eating disorder history
5. night shift work
6. pregnant, breast feeding, or trying to get pregnant
7. dementia, psychological, psychiatric, or neurological diagnoses
8. active brain or central nervous system disease
9. prior or current use of memory enhancing medications
10. history or current brain radiation
11. frequently fasting for 12+ hours every night

13) history of hypoglycemia 14) depression screening on PHQ9 with a score of 20 or greater across all 9 questions OR anything other than 0 on question 9