cyrilzakka/clinical-trials huggingface dataset:
Fetal Cardiac Strain Imaging Research

Cardiac disease in children may start early in life and evidence of cardiac disease can be seen during prenatal life. A variety of diseases diagnosed during fetal life can put children at risk for cardiac disease. The accurate assessment of cardiac function is important in these patients. A type of imaging scan called "fetal echocardiogram" is used to measure the contractility or squeeze of the heart. The fetal echocardiogram is a painless test and completely non-invasive.

This study aims to recruit women and fetuses to determine if this imaging scan can be used throughout the pregnancy to measure heart squeeze and develop normal values to help doctors better diagnose fetuses who may have cardiac disease before they are born.

The subject will have to complete 6 fetal echocardiograms. A fetal echocardiogram is picture of the unborn baby's heart in motion made by bouncing sound waves off the heart and recording the echo. The procedure will be very similar to the ultrasounds that the subject is already receiving as part of her prenatal care.

The scans will start at week 20 of the subject's pregnancy and repeat every 3 weeks until week 38 of birth (whichever occurs first). The appointments will last approximately 30 minutes each and will be performed by one of two sonographers trained specifically in fetal echocardiography. One additional echocardiogram will be performed on the infant after birth, within the first two months of life. In addition to the scans, study staff will access the subject's medical record to collect information such as: age, ethnicity, race, medical history and health insurance status.

Eligibility Criteria:
Inclusion Criteria:

* Patient at the obstetrics clinic at Texas Children's Hospital Pavilion for Women at the time of their second trimester screening ultrasound
* Fetus must have no recognizable disease at the second trimester screening ultrasound
* Willing to participate in a total of 5 fetal echocardiograms and one within 2 months after delivery
* English or Spanish literacy
* A four chamber view of the heart must be visible upon screening examination
* No fetal anatomic or growth abnormalities suspected on screening examination.

Exclusion Criteria:

* Subjects that meet the cutoff point for maternal obesity (BMI\>30) and have identified risk factors for fetal cardiac dysfunction as determined by medical team.
Markers of Carnitine Acetyltransferase (CrAT) Protein Activity and Carnitine Availability

This study aims to measure skeletal muscle metabolism in vivo during exercise using the non-invasive Magnetic Resonance Spectroscopy (MRS) technique. Specifically, phosphocreatine (PCr) kinetic and Acetylcarnitine levels will be determined at resting, during exercise and during the recovery post exercise. The target population is adult healthy men, with a wide range of maximal physical capacity.

Skeletal muscle mitochondrial activation during the transition from resting metabolism to exercise may modulated by CrAT activity. Furthermore, dynamic changes in acetylcarnitine during the transition from exercise to resting metabolism (acetylcarnitine off-kinetic) may also reflect the action of CrAT protein. To date, the only possibility to get information on CrAT activity is by taking a muscle biopsy and perform enzyme activity assays ex vivo. By dynamic MRS scanning, it might be possible to deduce information that reflects CrAT activity, thereby making the biopsy sampling unnecessary.

Eligibility Criteria:
Inclusion Criteria:

* Males, Generally healthy
* Age 18-40 years old
* BMI 18 - 25 kg/m2
* No medication use that interfere with the aims of the study
* Stable level of daily physical activity or training for at least 6 months

Exclusion Criteria:

* Females
* Regular smokers, drug abuse
* Participation in other studies
* Weight gain/loss \> 3 kg in the last 6 months
* Contraindications for MRS scans:
* Vegetarian eating behavior
Assessment of Plant-based Program Using Shared Medical Appointment

Evaluation of the impact of a whole food, plant-based (WFPB) program using shared medical appointments (SMAs) on reducing cardiovascular risk factors and weight loss in overweight/obese adults with at least one chronic disease

The study will use a single-arm with participants enrolled in three groups of 15 each (n=45) into the Green Wellness Program: Plants-2-Plate, an established program focusing on WFPB predominant eating pattern in an academic primary care setting. The program will offer 14 SMAs in a period of 6 months. Participants will attend the SMA weekly for 3 months, followed by a monthly SMA for the last 3 months of the intervention period. In the first session, participants will receive information about the program, and establish a health goal to be met at the end of the program. Each weekly SMA will have a nutrition education lesson, and feedback from the FNP, RN and RD after a brief assessment on health, medication adjustment, food choices, and shared ideas and experiences among the participants. At the end of the session, participants will set a small health goal to be followed during the week with assistance from the inter-professional team. The WFPB dietary approach includes vegetables, fruits, legumes, whole grains, seeds, nuts in small portion, elimination of all or most of animal foods, and reduction of processed food. Participants will eat ad libitum. In addition, they will receive support to manage stress, improve quality of sleep, and increase physical activity during the SMA.

Eligibility Criteria:
Inclusion Criteria:

* Men and women \>18 years
* Either overweight (BMI \> 25kgm-2) or obese (BMI \>30 kgm-2)
* Diagnosis of one or more chronic diseases
* Own a smartphone or tablet that has reliable interned/data access
* Agrees to comply with all study requirements
* Can speak and understand English

Exclusion Criteria:

* Diagnosis of cancer
* Previous participant in Green Wellness program: Plants-2-Plate
* Pregnant or planning to become pregnant
* Breastfeeding
* Concurrent weight loss program
* Plans to leave the city or USA for over 2 weeks within 6 months of enrollment
A Long-Term Safety and Tolerability Extension Study Evaluating Atogepant for the Prevention of Chronic or Episodic Migraine

This study will evaluate the Long-Term Safety and Tolerability of Atogepant 60 mg daily for the Prevention of Migraine in Participants with Chronic or Episodic Migraine


Eligibility Criteria:
Inclusion Criteria:

- Eligible participants who completed Visit 7, and Visit 8 if applicable, of Study 3101-303-002 or Study 3101-304-002 without significant protocol deviations and who did not experience an Adverse Event that may indicate an unacceptable safety risk.

Exclusion Criteria:

* Participants requiring any medication, diet, or nonpharmacological treatment on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative.
* Participants with an ECG indicating clinically significant abnormalities at Visit 1.
* Participants with hypertension at Visit 1.
* Participants with a significant risk of self-harm, or of harm to others; participants who report suicidal ideation with intent, with or without a plan, since the last visit, must be excluded.
* Participants with clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.
Influence of Different Methods of Measurement in the Accuracy of DES-OSA and P-SAP Scores

DES-OSA and P-SAP scores have been validated to detect OSA (Obstructive Sleep Apnea).

One item of P-SAP and DES-OSA is the measurement of neck circumference. The aim of this study is to compare the influence of different methods of neck circumference measurement in the accuracy of DES-OSA and P-SAP scores to detect OSA.


Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for an anesthetic preoperative consultation

Exclusion Criteria:

* \< 18 years
Peri Kasai Portoenterostomy Anchoring of the Jejunal Loop

the study of the effect o the hanging of the jejunal loop to the peri KPE Glisson capsule on the rate of bile drainage and requirement of liver transplantation

To evaluate the effect of anchoring jejunal loop to Glisson capsule of liver after completion of modified Kasai portoenterostomy (KPE) on the frequency of attacks of cholangitis and the overall incidence of native liver survival.

Methods: Retrospective study included 29 infants diagnosed as biliary atresia (BA). They were subjected to modified KPE. Two subgroups were present. Group A included 16 infants and had KPE. Group B included 13 infants and had the assumed modification. Wider dissection of fibrous portal plate was considered in both groups. After completion of KPE, the jejunal loop anchored to Glisson capsule of liver at porta hepatis in group B.

Eligibility Criteria:
Inclusion Criteria:

* infants with biliary atresia diagnosed and treated before 60th day of age

Exclusion Criteria:

* infants older than 60 days
Vegetable Intake Effect on Heterocyclic Amine Metabolism

This is a randomized trial with crossover design, where each participant will undergo four study phases with a different test meal at the end of each phase. Every phase will consist of subjects consuming for six days their normal diet excluding cruciferous and apiaceous vegetables, alcohol, and caffeine. The participants will refrain from meat products for 24 hours prior to the test meal. On day seven of each phase and after an overnight fast, subjects will be randomly assigned to eat one of four meals:

1. grilled hamburger with no vegetables
2. grilled hamburger with steamed broccoli and Brussels sprouts
3. grilled hamburger with steamed parsnips, fresh parsley, and celery sticks
4. grilled hamburger with steamed broccoli, Brussels sprouts, and parsnips plus fresh parsley and celery sticks.

Colon cancer is the third most common cancer in the U.S. Convincing evidence suggests that high intake of red meat increases colon cancer risk, according to the 2007 AICR/WCRF Second Expert Report. The likely responsible mutagens are heterocyclic aromatic amines (HAA), which form naturally during the cooking of meat, poultry, and fish at high temperatures. Bioactivation of HAA to carcinogenic metabolites is primarily mediated by phase I biotransformation enzymes. Evidence suggests that the activity of many of these enzymes can be modulated by constituents in apiaceous vegetables (parsnips, celery, etc.) and cruciferous vegetables (broccoli, cabbage, etc.)

In this trial researchers are comparing the effects of eating cruciferous vegetables, apiaceous vegetables, or both groups combined on HAA metabolism after eating grilled hamburger together in a single meal. They aim to define optimal dietary patterns and food combinations that maximize the safe excretion of dietary carcinogens through this trial. This contribution is significant because the knowledge gained will be applicable to the prevention of colon cancer as well as additional cancers.

Eligibility Criteria:
Inclusion Criteria:

* 18 years old or older
* Healthy
* Non-smoker

Exclusion Criteria:

* No history of gastrointestinal, hepatic, or renal disorders
* Not currently taking any prescription or over-the-counter medications
* Not currently taking any herbal/vitamins supplements
* Not pregnant or lactating
* No allergies or intolerances to the foods that will be used in the study (parsnips, parsley, celery, broccoli, Brussels sprouts, and hamburger)
The Effect of Ferric Carboxymaltose on Hemoglobin and Blood Transfusion in Cardiac Surgery

Anemia after cardiac surgery is a vast phenomena. More than 70% of the patients who under went surgery represented with hemoglobin less than 8 mg/dl (the cutoff for blood transfusion) and more than 80% of the patients receives at least one unit of red blood cell transfusion.

There were number of attempts to prevent the postoperative anemia by giving erythropoietin, Iron per os and intra venus iron. non of the above have shown increase in Hemoglobin after the cardiac surgery.

Research Objectives

The study objectives are:

1. Determine hemoglobin values in non-anemic patients given ferric Carboxymaltose prior to and post heart surgery.
2. Determine the effect of ferric Carboxymaltose in non-anemic patients prior to surgery on the number of blood units administer postoperation.

Research Methods Prospective, randomized, double-blind, placebo-controlled research. All patients who are in the cardiac surgery department for bypass surgery, valve replacement surgery or combined surgery will be eligible to participate in the study. The study will be presented and explained to all patients and, if they consent, patients will be divided into two random groups. One group will receive Ferinject IV 24-48 hours prior to surgery. The second group will receive a placebo drug in the same time period as when the drug Ferinject is administered.

The Population Studied All patients aged 18 or older hospitalized at the Rambam Medical Center and are candidates for open-heart surgery (coronary artery bypass, valve, combined).

Eligibility Criteria:
Inclusion Criteria:

1. Age 18 and older
2. Patient candidates for open heart surgery (coronary artery bypass, valve replacement, or a combination of both).
3. Hemoglobin above 12g/dL in women and above than 13g\\dL in men.

Exclusion Criteria:

1. Patients who require emergency heart surgery.
2. Patients who are not hemodynamically stable or intubated pre-operatively.
3. Patients with a known sensitivity to iron.
4. Patients with a known history of allergies (rashes, etc.).
5. Patients with liver failure (alanine aminotransferase\> 3 times normal).
6. Patients with cirrhosis.
7. Patients with an active infection.
8. Patients with rheumatoid arthritis and indications of an active infection.
9. Pregnant women.
10. Lactating women.
11. Patients with anemia prior to surgery for any reason (B12 deficiency or folic acid deficiency).
12. Patients participating in another drug trial.
13. Patients treated with iron who took medication within the four weeks prior to surgery.
14. Patients who received a blood transfusion in the four weeks prior to surgery.
Gait Control of Stroke Patients Using Visual Feedback

The purpose of this study is to determine the possibility of gait pattern change via visual feedback among patients with stroke. Also, the optimal visual feedback would be chosen from this study.


Eligibility Criteria:
Inclusion Criteria:

* Hemiplegic stroke patients \>= 18 years old
* Functional Ambulation Category \>=3
* Cognitively intact enough to follow the study protocol
* Adults without any gait problem

Exclusion Criteria:

* Quadriplegic stroke patients
* Orthopedic problems to affect gait
* Underlying other neurological or psychological disorders
* Spasticity or contracture which impede the gait.
* Uncontrolled medical problems
* Pregnant.
Wavefront-guided LASIK for Correction of Myopia

Laser in situ keratomileusis is a successful procedure for the treatment of low to moderate myopia.

Advances over the last decade have allowed LASIK to also correct higher order wavefront aberrations. In low myopia, there seem to be a minor effect of such wavefront-guided treatment. However, it remains to be established whether there is a beneficial effect in higher degrees of myopia.

The study aims to determine whether myopic subjects (-6 to -10 diopters) with higher-than-average preoperative higher-order aberrations have benefit of wavefront-guided treatment. Subjects are randomized to wavefront-guided treatment in one eye, and conventional treatment in the other.


Eligibility Criteria:
Inclusion Criteria:

* Age 20 to 50 years
* No known ocular or systemic disease
* Not pregnant or breastfeeding
* Myopia between -6.0 and -10.0 diopters
* Astigmatism below 2.0 diopters
* Difference of less than 1.0 diopters in spherical equivalent between eyes
* Normal corneal topography
* Corneal thickness sufficient for planned treatment

Exclusion Criteria:

* Patients that do not fulfill inclusion criteria
* Insufficient quality of ocular wavefront measurement
Comparative Study of Antiperistaltic vs Isoperistaltic Billroth II + Braun Anastomosis for Postoperative Reflux

Postoperative gastroesophageal reflux is one of the most common complications of distal gastrectomy. With more attention paid on it by surgeons, several new operation methods have been practised. Among all these, distal gastrctomy with Billroth II + Braun anastomosis was reported to be an useful method to decrease postoperative reflux rate. Meanwhile, the direction of anastomotic peristalsis has also been reported to affect the anastomosis and thus make difference in reflux rate. We design this study to investigate the potential effect and the superiority of antiperistaltic vs isoperistaltic Billroth II + Braun reconstruction in distal gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically diagnosed as gastric cancer before surgery
* Clinical staging: cT1-4aN0-3M0
* Postoperative evaluation concluded B-II B anastomosis
* Consent assigned

Exclusion Criteria:

* Diagnosed with other malignancies within 2 years
* Gastric cancer with clinical staging: cT4b or M1
* Women with pregnancy or breast-feeding
* Emergency procedures
* Consent not assigned
Evaluation of Loteprednol Etabonate Versus Vehicle for the Treatment of Inflammation and Pain Following Cataract Surgery

This study is being conducted to compare the safety and efficacy of loteprednol etabonate to vehicle for the treatment of postoperative inflammation and pain following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Subjects who are at least 18 years of age.
* Subjects who are candidates for routine, uncomplicated cataract surgery.

Exclusion Criteria:

* Subjects who have known hypersensitivity or contraindication to the study drug or components.
* Subjects with a severe/serious ocular condition, or any other unstable medical condition, that in the investigator's opinion may preclude study treatment or follow-up.
* Subjects with elevated intraocular pressure (\>/=21mm Hg), uncontrolled glaucoma, or being treated for glaucoma in the study eye.
* Subjects who are monocular or have pinholed Snellen visual acuity (VA) 20/200 or worse in the non-study eye.
Subacromial Injection of Allogeneic Platelet Rich Plasma (PRP) for Shoulder Impingement Syndrome

The purpose of this study is to investigate the efficacy of allogeneic PRP in patients with subacromial impingement disease


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age and older
* Patients who have unilateral shoulder pain.
* Patients who have had pain at least for 3 months
* To be included in the study- participants are required to have a \& b.(mentioned below)

  1. Pain with one of the two tests

     * Neer's sign: passive overpressure at full shoulder flexion with the scapula fixed
     * Hawkins test: passive internal rotation at 90 degree of shoulder flexion in the scapular plane and in progressive degree of horizontal adduction
  2. Pain with one of the two tests

     * Painful arc: active shoulder abduction
     * Jobe's test: The examiner passively elevates the patient's shoulder to 90 degrees of abduction with internal rotation. The examiner then applies a downward pressure against the arm

Exclusion Criteria:

* Patients who received any drug by subacromial injection for treatment within 3 months prior to this enrollment.
* Patients who have a history of shoulder trauma including dislocation- subluxation- and fracture- breast cancer- or surgery around shoulder- neck and upper back
* Patients who have a isolated acromioclavicular joint pathology
* Patients who have a full-thickness rotator cuff tear (evidenced by MR or ultrasonography)
* Patients with symptomatic cervical spine disorders
* Patients who have a History of allergic adverse reactions to corticosteroid
* Patients are unable to give informed consent to participate in the study
* Patients are unable to come into the clinic for regular follow-up
* Patients with adhesive capsulitis- acromioclavicular arthropathy- polyarthritis- infectious arthritis- rheumatoid arthritis or diagnosed fibromyalgia
* Patients with concurrent bilateral shoulder pain
* Patients with neurological deficit
* Patients who have severely abnormal radiological findings including malignancy, severe osteoarthritis of the glenohumeral joint, severe skeletal abnormalities decreasing the subacromial space and etc.
* Presence of shoulder pain with limitation of both active and passive movements of the glenohumeral joint of 25% in at least 2 directions (abduction, flexion, external rotation, internal rotation), as compared with the contralateral shoulder or with normal values
* Patients with Diabetes mellitus
* Patients taking anticoagulants
* Pregnant women or lactating mothers
* Patients who are difficulty participating in data collection due to communication problem and serious mental illness
* Patients with serious condition which can affect this study such as severe cardiovascular diseases- renal diseases- liver diseases- endocrine diseases- and cancers
The Effectivity and Safety Study of rExenatide-4 in Chinese Type 2 Diabetes Mellitus

This research is a randomized, double-blind,controlled trial. 456 Chinese subjects with Type 2 Diabetes Mellitus will be enrolled in the trial.

This is a multicenter, randomized, blinded, placebo-controlled study to assess the effects on glucose control of rE-4 as compared to placebo in patients with type 2 diabetes. Patients will be randomized into one of two rE-4 treatment arms or to placebo treatment and will continue with their required existing diabetes medications (metformin, a sulfonylurea or metformin and a sulfonylurea combination) throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. T2DM
2. 7.0% ≤ HbA1c ≤ 11.0% at screening
3. FPG ≤13.8 mmol/L
4. 19 kg/m2 \< BMI \<35.0 kg/m2 at screening
5. All subjects provided written informed consent before participation

Exclusion Criteria:

1. T1DM
2. Patients treated previously with Exenatide or GLP-1 similar
3. At screening visit alanine aminotransferase (ALT) or alkaline phosphatase (AST) more than 2.5 ULN
4. At screening visit estimated glomerular filtration rate (eGFR) ≤ 60 mL/min or Triglyceride(TG)≥ 5 mmol/L
5. Pancreatitis, cholecystitis, gallstones and other gastrointestinal diseases
6. Within the last 12 months prior to screening visit: history of stroke, myocardial infarction, unstable angina, or heart failure requiring hospitalization. Planned coronary, carotid or peripheral artery revascularisation procedures to be performed during the study period
7. History of digestive diseases (e.g.pancreatitis, cholecystitis or gallstones)
8. Patients with severe renal impairment or end-stage renal disease
9. Uncontrolled or inadequately controlled hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 110 mmHg) at screening visit.
10. Use of weight loss drugs within 3 months prior to screening visit
11. Have been treated with exogenous insulin, α-glucosidase, corticosteroid, DPP-4 inhibitor or pramlintide acetate within the 3 months prior to screening.
12. Severe gastrointestinal disease (e.g., gastroparesis)
13. Pregnancy or lactation, women of childbearing potential with no effective contraceptive method
14. Participant who participated in any drug clinical trial within the last 3 months prior to screening visit
15. History of severe hypersensitivity to rExenatide-4 or any product components