cyrilzakka/clinical-trials huggingface dataset:
The Effect of Roux-en-Y Gastric Bypass on Insulin Sensitivity in Type 2 Diabetes

Gastric bypass surgery induces remission of diabetes within days after surgery, before significant weight loss. The aim of the study is to examine whether improved insulin sensitivity of muscle and liver contributes to the immediate diabetes resolution.

Obesity has become a severe epidemic globally. With the rapid increase in obesity comes a pronounced rise in obesity-related disorders, especially type 2 diabetes. Weight loss achieved through lifestyle changes improves diabetes, but is very difficult to maintain over time. In contrast, Roux-en-Y gastric bypass (RYGB) surgery can induce long-term weight loss and remission of diabetes. Surprisingly, the resolution of type 2 diabetes occurs within days after surgery and before significant weight loss. The resolution of diabetes must therefore be explained by a response to the surgical alterations of the stomach and intestines: restriction in gastric volume and bypass of the stomach, duodenum and proximal jejunum.

Severe insulin resistance in muscle and liver is the common defect in obesity and type 2 diabetes and may be improved or even reversed shortly after the operation. The aim of this study is to examine the acute changes in insulin sensitivity of muscle and liver by using hyperinsulinaemic euglycaemic clamp combined with glucose tracer to assess hepatic glucose production. Insulin signaling pathways will be studied in biopsies from muscle and subcutaneous fat as to explain the molecular basis of the changes in insulin sensitivity after RYGB.

Insulin secretion will be evaluated in response to oral glucose as well as iv glucose-glucagon.

Eligibility Criteria:
Inclusion Criteria:

* patients eligible for gastric bypass surgery
* Verified type 2 diabetes or normal glucose tolerance by oral glucose tolerance test (OGTT)

Exclusion Criteria:

* Treatment for Hyperthyroidism
Mri characterIzation of Troponin Elevation After Cardiac Surgery

Cardiac surgery under cardiopulmonary bypass (CPB) induces myocardial ischemia-reperfusion injury. This myocardial attack is a well-identified independent prognostic factor of postoperative morbidity and mortality. The quantification of these myocardial lesions by the postoperative plasma release of troponin has proven its diagnostic and prognostic value.

Cardiac magnetic resonance imaging (MRI) can accurately measure and characterize the size of myocardial lesions. These lesions are associated with a poor prognosis. MRI can also characterize myocardial edema secondary to ischemia-reperfusion which has not yet been studied in the context of CPB. It is therefore necessary, in a mechanistic approach, to quantify the respective share of necrosis, edema and reperfusion lesions during cardiac surgery under CPB in order to better understand these phenomena and to propose effective strategies for the prevention of these myocardial lesions.the relationship between the postoperative release of troponin and the amount of myocardial necrosis and edema measured by cardiac MRI will be assessed.The hypothesis is to demonstrate a positive correlation between imaging and biology in order to better understand the perioperative myocardial lesion processes.

This is an interventional study prospective, exploratory, in cardiac imaging, non-comparative and single-center, including 30 patients.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Aortic valve surgery with CEC: aortic valve replacement, Bentall, Tirone-David, Wheat with foreseeable clamping time of at least 40 minutes.
* Informed consent signed

Exclusion Criteria:

* Emergency surgery
* Other unconventional heart surgery
* Aorto-coronary bypass associated with surgery
* History of myocardial infarction or severe coronary artery disease, non-valvular hypertrophic cardiomyopathy (MHC) (primary MHC type, Amyloidosis) and myocarditis
* Preoperative alteration of systolic function of the left ventricle (LVEF \<40%)
* Presence of a contraindication to cardiac MRI (claustrophobia, pacemaker or cardiac defibrillator, metallic body, hypersensitivity to gadolinium)
* Patients with a glomerular filtration rate (GFR) \<30 ml / min
* Patients with permanent atrial fibrillation (ACFA) cardiac arrhythmia
* Patients treated with anthracyclines
* Pregnant and / or lactating woman
* Patient under legal protection
* Patient not benefiting from a social security system
* Patient participating in another clinical study that may interfere with the results of this study.
Microarray Analysis of Gene Expression in Prostate Tissues

The purpose of this study is to investigate gene expression profiles and biologic features of prostate tissue and how they relate to prostate cancer development and growth.


Eligibility Criteria:
Inclusion Criteria:

- Patient scheduled to undergo either a biopsy or surgery for a prostate condition.

Exclusion Criteria:

- Patients without a prostate condition
Epidemiology and Outcome of Pediatric Traumatic Cataract

this study aims to explore the demography of pediatric traumatic cataract in upper Egypt, and report outcomes and complications of traumatic cataract surgery in these children.

Ocular trauma is one of the leading causes of acquired unilateral blindness in childhood.1,2 Apart from the permanent disability, ocular trauma has a profound impact on both patients and society at different levels, including, but not limited to, psychological trauma, cosmetic disfigurement, socioeconomic costs, and the need for specialized medical care and vocational rehabilitation.

Traumatic cataract is a common complication of pediatric eye injury. In developing countries, ocular trauma was responsible for up to 45% of childhood cataract. Vision loss induced by traumatic cataract is surgically manageable. However, the high risk of postoperative inflammation, posterior capsular opacification (PCO), amblyopia, and the associated ocular tissue damage may negatively impact visual outcome.

Several studies reported visual outcome of pediatric traumatic cataract in different populations. With the sacristy of studies on traumatic cataract in Egyptian children, we conducted this retrospective study to report the demographic features, visual outcome, and complications of pediatric traumatic cataract at Assiut University Hospital, the biggest tertiary referral center in Upper Egypt.

Eligibility Criteria:
Inclusion Criteria:

* All children who have undergone traumatic cataract surgery at Assiut university over 1 year period.

Exclusion Criteria:

* children with posterior segment injury.
* children who did not complete at least 6 months of postoperative follow-up.
Minimally Invasive Groin Dissection for Melanoma

The purpose of this this study is to determine if a structured educational training program is successful in teaching surgeons a new operative technique. It will then be determined if this new operative technique is safe.

This study is a multi-center, Phase 1 clinical trial to determine the safety and feasibility of minimally invasive inguinal lymph node dissection for patients with melanoma. Licensed surgeons who have undergone special training, including a course at the Mayo Clinic Rochester in minimally invasive lymph node dissection (MILND) will perform the new procedure at their home institutions. The study will characterize the learning curve of MILND in the clinical setting, and evaluate the safety of the new operative technique.

The hypotheses for this study are: 1) minimally invasive groin dissection is a safe procedure. 2) a structured educational training program is a feasible and effective method to train practicing surgeons in this novel procedure and 3) pre-course generic laparoscopic technical skills correlate with minimally invasive superficial groin dissection performance in a clinical setting, including operative oncologic standards and safety metrics.

Eligibility Criteria:
Inclusion criteria:

* Malignant melanoma present in an inguinal nodal basin requiring superficial inguinal lymph node dissection.
* Plan for superficial inguinal dissection alone or combined superficial inguinal and deep pelvic node dissection is acceptable.
* Clinical or radiographic evidence of superficial inguinal lymph node disease or a prior positive single lymph node biopsy of the superficial inguinal basin as an indication for superficial inguinal lymph node disease is acceptable.
* Patients must be Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 and be healthy enough to undergo a general anesthetic (no epidural or spinal anesthetics).
* Female patients of child bearing age must have a negative pregnancy test, be surgically sterile or post-menopausal greater than 1 year.
* Patients must be able to return to surgical facility for 30 and/or 90 day (+/- 20 days) for follow-up appointment.

Exclusion Criteria:

* Prior ipsilateral superficial inguinal lymph node dissection
* Invasion or ulceration of inguinal nodal disease into the overlying skin
* Prior radiation therapy to the same regional nodal basin.
Blood Glucose Monitoring in Electronic Health Records

This multi-site randomized tral aims to test methods of increasing adoption and integration of blood glucose monitoring into electronic medical records, and to measure the impact of wide-scale adoption on health status of patients with diabetes. To investigate determinants of adoption, the research will combine and test doctor and patient focused approaches to encouraging patient use of blood glucose flow sheets through the online patient portal, MyChart. Adoption will be measured on both the extensive and intensive margin: the number of patients who enter data into the flowsheets at all during the study period, and the mean number of entries per patient during the study period. Conditional on statistically significant increases in adoption, the study will examine corresponding intent-to-treat effects on patient A1c, and consider other indicators of possible mechanisms through which A1c improves or does not improve.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients of Inova physicians at primary care sites other than Ashburn II Primary Care, Lake Ridge Primary Care and Springfield Primary Care
* Current diabetes mellitus diagnosis
* Active MyChart account at time of treatment administration

Exclusion Criteria:

* Patients who participating physicians identify as pregnant
* Patients who participating physicians identify as having contraindications for tracking of blood glucose
Study to Evaluate Patients With Cerebrotendinous Xanthomatosis (RESTORE)

The study is made up of two cohorts: a randomized double-blind crossover (placebo withdrawal with rescue) study among patients ≥ 16 years of age (adult cohort) and an open-label dose titration study among pediatric patients ≥1 month and \<16 years of age (pediatric cohort)


Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 1 month or older at screening.
2. Clinical diagnosis of CTX with biochemical confirmation.
3. Women of childbearing potential must agree to the use of one highly reliable method of contraception during the study, plus one additional barrier method during sexual activity.
4. Males must be surgically sterile, or males and their sexual partners must together agree to use medically accepted methods of contraception that are considered highly reliable during the course of the study.

Exclusion Criteria:

1. Genetic testing does not confirm CTX.
2. Malabsorption disorder or confounding inflammatory gastrointestinal condition (for example, irritable bowel syndrome).
3. Documented history of heart failure.
4. Treated with medications which impact bile acid absorption such as bile acid sequestering agents (eg, cholestyramine, colestipol, aluminum-based antacids.
5. Treated with cholic acid medication.
6. Female patient who is pregnant, plans to become pregnant during the course of the study, or is breastfeeding.
7. Positive at screening for the human immunodeficiency virus (HIV) or markers indicating acute or chronic hepatitis B infection or hepatitis C infection.
Optimizing Pain and Rehabilitation After Knee Arthroplasty

The aim of this study is to determine the best method of pain control that will help with rehabilitation after total knee arthroplasty (TKA). Currently, the best method for pain control after TKA appears to be continuous femoral nerve block (FNB) where a small tube is placed beside the nerve that provides sensation to a large part of the knee and local anesthetic infused after surgery causing numbness to the surgical site. A single injection method also exists and may provide similar benefits. Both methods require training and can result in side effects such as temporary weakness (while the local anesthetic is still working) that can inhibit rehabilitation. A newer method injecting local anesthetic into the joint after surgery (Local Infiltration Analgesia (LIA)) is becoming common, does not cause weakness and can be done quickly at the end of surgery. It is unknown if the pain control provided by LIA is as good as that of FNB. This study will compare the femoral nerve block, continuous femoral nerve block and LIA technique to determine which provides better pain relief after TKA.

This will be a prospective, randomized, double blind study. Patients will be randomized using a computer-generated sequence to one of three groups:

Group 1: Continuous femoral nerve block group (cFNB) Group 2: Single injection femoral nerve block group (sFNB) Group 3: Local infiltration analgesia group (LIA)

Inclusion criteria: Patients between the ages of 18 and 85 having primary tri-compartmental total knee arthroplasty.

Exclusion criteria: Allergy, intolerance, or contraindication to any study medication (see below), inability to walk independently prior to TKA, inability to comprehend French or English, use of major tranquilizers, ASA 4 or 5, BMI \> 40, opioid tolerance (opioid consumption \> 30mg oral morphine or equivalent per day), pregnancy

Eligibility Criteria:
Inclusion Criteria:

* Adults undergoing primary, tri-compartmental knee arthroplasty

Exclusion Criteria:

* Allergy, intolerance, or contraindication to any study medication
* Inability to walk independently prior to TKA
* Inability to comprehend French or English
* Use of major tranquilizers
* ASA 4 or 5
* BMI \> 40
* Opioid tolerance (opioid consumption \> 30mg oral morphine or equivalent per day)
* Pregnancy
Risperidone Tablets, 1 mg Bioequivalence Study of Dr.Reddy's Under Fasting Condition

A Single-dose, Randomized, two-Period, Cross over Study

Randomized, single-dose, two-way, crossover study was conducted to compare the relative bioavailability of two formulations of 1 mg risperidone tablets under fasting conditions.

The test formulation was Dr. Reddy's Laboratories Limited's Risperidone Tablets, 1 mg, and the reference formulation was Risperdal® (risperidone) tablets, 1 mg (Janssen Pharmaceutica Products, L.P.).

The study was conducted with 30 healthy adults. In each study period, a single 1 mg dose was administered to all subjects following an overnight fast.The subjects received the test product in one study period and the reference product in the other period; the order of administration was according to the dosing randomization schedule. There was a 7-day interval between treatments.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females, 18 - 55 years of age.
2. Female subjects of child bearing potential must either abstain from sexual intercourse or use a reliable method of contraception (e.g. condom with spermicide, IUD, hormonal contraceptives) for at least 30 days prior to dosing and during the duration of the study.
3. A body mass index (BMI) of 18-30 kg/m² inclusive as calculated according to Novum Standard Operating Procedures.
4. Good health as determined by lack of clinically significant abnormalities in health assessments performed at screening.
5. Signed and dated informed consent form, which meets all criteria of current FDA regulations.

Exclusion Criteria:

1. If female, pregnant, lactating or likely to become pregnant during the study.
2. History of allergy or sensitivity to risperidone, or similar drugs, or history of any drug hypersensitivity or intolerance which, in the opinion of the Investigator, would compromise the safety of the subject or the study.
3. Significant history or current evidence of chronic infectious disease, system disorder or organ dysfunction.
4. Presence of gastrointestinal disease or history of malabsorption within the last year.
5. History of psychiatric disorders occurring within the last two years that required hospitalization or medication.
6. Presence of a medical condition requiring regular treatment with prescription drugs.
7. Use of pharmacologic agents known to significantly induce or inhibit drug-metabolizing enzymes within 30 days prior to initial dosing.
8. Receipt of any drug as part of a research study within 30 days prior to dosing.
9. Drug or alcohol addiction requiring treatment in the past 12 months.
10. Donation or significant loss of whole blood (480 ml or more) within 30 days or plasma within 14 days prior to dosing.
11. Positive test results for HIV, Hepatitis B surface antigen, or Hepatitis C antibody.
12. Positive test results for drugs of abuse at screening.
13. Positive serum pregnancy test.
14. Subjects who smoke more than 10 cigarettes/day or equivalent tobacco use.
15. Subjects who have been on a special diet during the 28 days prior to dosing
16. Subjects who consume on average more than 3 units of alcohol/day.
Effects of Vitamin D and Fish Oil on the Kidney in Hypertensives

The VITamin D and OmegA-3 TriaL (VITAL; NCT01169259) is an ongoing randomized clinical trial in 25,875 US men and women investigating whether taking dietary supplements of vitamin D3 (2000 IU) or omega-3 fatty acids (Omacor (R) fish oil, 1 gram) reduces the risk of developing cancer, heart disease, and stroke in people who do not have a prior history of these illnesses. The VITAL Kidney Function in Hypertension ancillary study will evaluate the effects of vitamin D or omega-3 fatty acids on kidney function among participants with baseline hypertension.

This ancillary study to the VITamin D and OmegA-3 TriaL (VITAL) will test whether vitamin D3, omega-3 fatty acids, or both prevent the development and progression of kidney disease in participants with hypertension. Persons with hypertension are at high risk of kidney disease.

Vitamin D and omega-3 fatty acids are promising interventions for kidney disease prevention and treatment, based on results of animal-experimental models and early human studies. Because these interventions are relatively safe, inexpensive, and widely available, they may offer opportunity to substantially reduce the burden of kidney disease in large populations. This VITAL ancillary study will test whether vitamin D3 and/or omega-3 fatty acids prevent loss of glomerular filtration rate, over 4 years of therapy.

In VITAL, 25,875 participants have been randomly assigned in a 2x2 factorial design to vitamin D3 (cholecalciferol) 2000 IU daily versus placebo, and to eicosapentaenoic acid 465 mg plus docosahexaenoic acid 375 mg daily versus placebo, and followed for a mean of 5 years to assess effects on cardiovascular disease and cancer events. This ancillary study will identify and recruit a sub-cohort of VITAL participants with hypertension at baseline and ascertain effects of study interventions on glomerular filtration rate in this group. Blood samples will be collected at year 4 simultaneously for measurement of estimated glomerular filtration rate (using serum creatinine and cystatin C) and other relevant biomarkers. This VITAL ancillary study is designed to determine whether vitamin D3 and/or omega-3 fatty acids have causal and clinically relevant effects on the development and progression of kidney disease in hypertensives.

Eligibility Criteria:
Inclusion Criteria:

* Participants in VITAL (NCT01169259) with a self-reported physician diagnosis of hypertension are eligible to participate in this ancillary study

Exclusion Criteria:

* Diagnosis of diabetes mellitus
Chairside Time and Accuracy of Indirect Bonding of Orthodontic Attachments Using Double Versus Single Transfer Tray

compare the chairside time and the accuracy of transferring attachments between single and double sheets vacuum tray techniques during indirect bonding of orthodontic attachments using superimposition on computer software


Eligibility Criteria:
Inclusion Criteria:

1. Patient with maxillary full set of teeth and undergoing fixed orthodontic treatment.
2. Good oral hygiene.
3. Mild to moderate crowding.

Exclusion Criteria:

1. Patients with partially erupted teeth in the maxillary arch.
2. Signs of caries, large restorations or abnormalities of crown morphology.
3. The need of banding.
4. Bad oral hygiene measures.
Study of Indomethacin Capsules to Treat Pain Following Bunionectomy

The purpose of this study is to determine whether Indomethacin \[Test\] Capsules are safe and effective for the treatment of postoperative bunionectomy pain.


Eligibility Criteria:
Inclusion Criteria:

* Patient is male or female between 18 and 65 years of age
* For women of child-bearing potential: a woman who is not pregnant and not nursing, and who is practicing an acceptable method of birth control
* Has undergone primary, unilateral, first metatarsal bunionectomy with no additional collateral procedures
* Patient must be willing to stay at the study site ≥ 72 hours

Exclusion Criteria:

* Patient has hypersensitivity, allergy, or clinically significant intolerance to any medications to be used in the study, or related drugs
* Patient has a current disease or history of a disease that will impact the study or the patient's well-being
* Patient has used or intends to use any of the medications that are prohibited by the protocol
* Patient has a history of drug or alcohol abuse or dependence, or patient has a positive urine drug screen or alcohol breathalyzer test
* Patient has taken another investigational drug within 30 days prior to screening
Clinical Validation of a New Algorithm for Computerized Dosing of Vitamin K Antagonist Therapy

The purpose of this study is to determine whether the new algorithm is safety and effective in proposing the dosage and the timing of oral anticoagulant therapy.


Eligibility Criteria:
Inclusion Criteria:

* to take oral anticoagulant therapy for at least 2 years
* to be in stable conditions for at last 3 months

Exclusion Criteria:

* patients who need to perform surgery
* patients who interrupt therapy