cyrilzakka/clinical-trials huggingface dataset:
Long-term Investigation of Resveratrol in Obesity

The aim of this study is to investigate potential metabolic effects of resveratrol in men with metabolic syndrome(otherwise healthy).

The investigators hypothesize that resveratrol has an anti-inflammatory effect, and will increase insulin sensitivity, change the fat- and sugar-metabolism, and down-regulate bone-turnover.

The study will be done in a collaboration between two PhD students, who focus on effects in adipose- and muscle- tissue, and bone tissue respectively.

The investigators will look at changes in

* inflammation-markers
* biochemical markers of fat- and sugar-metabolism
* gene-expression in fat- and muscle-tissue
* body composition (DXA (whole body) and MR spectroscopy)
* biochemical markers of bone-metabolism
* Bone Mineral Density (DXA scans)
* bone structure (QCT)
* gene-expression and cytokines in bone marrow

Some of the volunteers will have their insulin sensitivity measured.

Eligibility Criteria:
Inclusion Criteria:

* Male
* 30-60 years old
* Metabolic Syndrome
* Written informed consent

Exclusion Criteria:

* Diabetes, thyroid or parathyroid disease, hypogonadism
* Treatment-requiring osteoporosis
* Heart, liver or kidney disease
* Present or previous malignancy
* MR contraindication
* Alcohol dependency
* Weight \> 130 kilograms
Evaluation of Volume Status Changes in Children on Regular Hemodialysis at Assiut University Children,s Hospital

Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months

Chronic kidney disease (CKD) is a major health problem worldwide.(1) Chronic renal failure is defined as a decrease in glomerular filtration rate (GFR) of less than 60 ml/min/1.73 m2 of body surface evolving for more than 3 months . The etiologies of CKD in children are three main groups of pathologies: congenital anomalies of the kidney and urinary tract , hereditary nephropathies and acquired causes . (2) complication of pediatric hemodialysis is chronic fluid overload, left ventricular hypertrophy ,hypertension, heart failure, decrease arterial flexibility and often results in increase chance of morbidity and mortality, So fluid overload must be prevented .(3) Lung ultrasonography is the most recent, safe, easy, and reliable technique . The most commonly observed finding is a comet tail fanning out from the lung-wall interface and spreading upwards to the edge of the screen, named a "B-line" Chest sonar advantages include its noninvasiveness , ease of use, availability of portable machines, avoidance of radiation detect lung edema even in initial non symptomatic cases known as hidden lung congestion .(4) Bioimpedance analysis (BIA) Bio impedance spectroscopy (BIS) is a technique used to estimate total body water, extracellular water, lean and adipose tissue mass and over hydration . (5) N-terminal pro-brain natriuretic peptide is used as a biomarker to aid to predict cardiac dysfunction in children and adolescents .(6)it is an effective marker of volume status in patient with or without reduced ejection fraction undergoing hemodialysis. (7)

Eligibility Criteria:
Inclusion Criteria:

- Patients aged 3 to 16 years having end stage renal disease undergoing regular haemodialysis for at least more than 6 months of both gender were enrolled

Exclusion Criteria:

* Patients with chronic lung disease ,or pulmonary infection in the last 2 months were excluded from study.

Patients with congestive heart failure Patients with Pulmonary edema Patient with pericardial effusion parental refusal to participate
Evaluation Effects of Nasal Nitric Oxide Measurements Are Associated With Atopy Status in Chronic Nasal Inflammation

Nitric oxide (NO) was considered as a mediator of nasal inflammation and the measurement of nasal nitric oxide (nNO) may assist in the diagnosis of nasal inflammation. Few data exists comparing nNO with established, larger accepted reference standard for chronic rhinosinusitis (CRS) diagnosis. Moreover, the role of atopic status on nNO in nasal inflammatory diseases has not been reported. The aim of our study was to determine the value of nNO in patients with chronic nasal inflammation, and to assess the relationship between nNO and atopic status in these patients. A total of 131 randomized patients suffering form chronic nonallergic nasal inflammation and 20 healthy volunteers were finally recruited. nNO was measured by NIOX devices. Sinus computed tomography (CT) scan, nasal endoscope and nasal symptoms evaluation were used in the different diagnosis of chronic rhinitis (CR), CRS without nasal polyps (CRSsNP) and CRS with nasal polyps (CRSwNP). Atopic status was confirmed by skin prick test and serum IgE levels. Blood eosinophils were evaluated simultaneously. Relationships among nNO, various atopic characteristics and chronic nasal inflammation were evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as CR, CRSsNP or CRSwNP based on the criteria of the European position paper.
* Had at least two or more symptoms, one of which was either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), and/or facial pain/pressure, and/or reduction or loss of smell;
* Either endoscopic signs of polyps and/or mucopurulent discharge primarily from the middle meatus and/or oedema/mucosal obstruction primarily in the middle meatus.

Exclusion Criteria:

* Pregnancy, lactation, significant psychologic problems, inability to comply with study protocol, children under 18 years of age, systemic diseases affecting the nose (e.g., Wegener's granulomatosis, sarcoid, and acute upper or lower respiratory tract infections within 2 weeks before the inclusion visit)
* Use of systemic corticosteroids within 2 weeks before the inclusion visit, systemic diseases preventing participation in the study, and medical or surgical treatments influencing the study.
* Patients with diagnosed atopic dermatitis and atopic asthma.
* Patients with diagnosed allergic rhinitis.
Unprepped CT Colonography

It is our objective to improve the performance of CTC in the prepared colon, and to validate CTC in the unprepared colon for the detection of colorectal neoplasia. The cost-effectiveness ratio of CTC in the unprepared colon will compare favorably with other colorectal screening test.

To improve the diagnostic performance of CTC in the prepared colon using improved spatial resolution, advanced image displays, and computer-assisted diagnosis, and to optimize diagnostic performance of CTC in the unprepared colon for colorectal polyp detection using electronic stool subtraction and computer-aided diagnostic techniques. To estimate the sensitivity and specificity of CTC in the unprepared colon for clinically important colorectal neoplasms (large adenomas ≥ 1 cm) and to compare such estimates with colonoscopy. To survey patient acceptance of CTC in the unprepared colon, and to assess implications for health care costs and cost-effectiveness of CTC in the unprepared colon in comparison with other approaches.

Eligibility Criteria:
Inclusion Criteria:

Average risk or higher for colorectal cancer and scheduled for colonoscopy with any of the following indications:

* Prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.
* Age ≥ 40 -100 years
* Known or highly suspected primary colorectal neoplasms \> 10 mm (n = 160)
* Higher than average risk for colorectal cancer and scheduled for colonoscopy with any of the following indications: prior colorectal cancer, prior colorectal adenoma, strong family history of colorectal neoplasia, iron deficiency.

Exclusion Criteria:

* Less than 1/2 of colorectum remaining
* Inflammatory bowel disease (Crohns, Chronic Ulcerative Colitis)
* Familial Polyposis
* Melena, hematochezia
Titanium Elastic Nails in the Treatment of Pediatric Femur Fractures

Titanium elastic nails in the pediatric femoral fractures: A prospective randomized clinical trial of eliminating nail protrusion to decrease soft tissue complications

This study will be conducted as a prospective cohort study of children and adolescents treated with TEN for a femoral shaft fracture. All children and adolescents presenting to the Emergency department of a participating center with a femur fracture will be approached for inclusion in the study. The primary outcome for this study will be functional recovery, as measured using a pediatric specific generic QOL measurement tool. The clinical outcome measure which will be used will be the performance version of the ASK (ASK-p) which has been previously tested and shown to be valid, reliable, and responsive in children and adolescents with acute and chronic Orthopaedic disorders. The first time point for data collection will be at four months. Clinical data which will be obtained over the course of follow-up will include clinical evaluation of hip and knee range of motion, limb rotation, clinical measurement of limb length, fracture union, and the presence of complications, including the need for nail removal in the group in which it was not planned. The second time point for data collection will be at one year. Again, the ASK-p will be mailed to all subjects in advance to allow completion at the desired time. The return of questionnaires and process for reminder notifications will proceed in a similar fashion to the four month time point. Clinical and radiographic data will be collected in a similar fashion to the four month time point. No subjects will be excluded on the basis of failure to return questionnaires at the one year time point since this represents a secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

open femoral physes; closed midshaft femur fracture; no concomitant injuries to either lower extremity; no history of injury to either femur; no history of asymmetric femoral malalignment; agree to participate in 2 years of follow up; informed consent/assent.

Exclusion Criteria:

open midshaft femur fractures; other injuries to either lower extremity; a history of injury to either femur; unable to comply with 2 years of follow-up
Long-term Persistence Study to Assess a Booster Dose of GSK Biologicals' Hib-MenC

This protocol posting deals with objectives \& outcome measures of the extension phase at Months 18, 30, 42, 54 and 66 post booster. The objectives \& outcome measures of the primary phase are presented in a separate protocol posting (NCT number = NCT00352963). The objectives \& outcome measures of the Booster phase/study are presented in a separate protocol posting (NCT number =NCT00323050).

The purpose of this study is to evaluate the persistence of meningococcal serogroup C and Hib antibodies on a yearly basis for a period of 5.5 years after booster vaccination. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.

This multicenter study is open. No vaccine will be administered during this persistence phase of the study. The subjects were randomized in the primary vaccination study 217744/097 (DTPa-HBV-IPV-097) and will not be further randomized in this study. The study has 3 groups with Meningitec™ primed group as control. The protocol was amended to allow for enrollment of subjects of the Meningitec™ primed control group who were boosted with Meningitec™ after the end of the booster study as per new local reccommendation in Spain.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who the investigator believes that their parents/guardians can and will comply with the requirements of the protocol.
* A male or female in their third year of life at the time of the study initiation for the subjects who enter the study at Visit 1. The subjects who enter the study at Visit 2 should be in their fourth year of life at the time of the study initiation.
* Written informed consent obtained from the parent or guardian of the subject.
* Healthy subjects as established by medical history and clinical examination before entering into the study.
* Having completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050).
* Subjects who are part of the Meningitec™ control group and who were not enrolled at Visit 1 can be enrolled at Visit 2 if they have completed the booster vaccination study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050) and if they have received a fourth dose of Meningitec™ in their second year of life, after the booster study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097 (NCT=00323050)

Exclusion Criteria:

* Previous administration of a booster dose of Hib or meningococcal serogroup C except booster study vaccines during the study Hib-MenC-TT-010 BST:DTPA-HBV-IPV-097. Subjects who received a 4th dose of Meningitec™ should be included in the study.
* History of H. influenzae type b, meningococcal serogroup C diseases.
Supporting Patients in Lifestyle Health Behavior Change by Medical Students at Primary Care Clinics in Zefat Israel

Medical students from zefad medical school volunteer to assist patients with chronic diseases to make lifestyle changes.

Each student will work closely with a family doctor who finds patients who need and want it accompanied by a change he introduced them and guide him on health status, medication and change the desired objectives.

In the program students will receive guidance on healthy lifestyle and support a patient to perform health changes in theoretical and practical. Training sessions will be held periodically, close supervision and guidance, counseling and cross-fertilization and updates from the scientific literature.

The challenge of the third millennium doorway medicine is dealing with an epidemic of chronic diseases caused by unhealthy lifestyle. Medical students spent many hours in acquiring knowledge in the medical professions but little time invested in studying fields related to medicine lifestyles.

On the other side, the family doctors in charge of health promotion in the community find themselves inundated with patients that often can make lifestyle on the one hand but a huge shortage of time for providing advice and support in favor of this issue on the other.

The Faculty of Medicine in Safed project exists "As you hear" where each student is asked to choose a project support and assistance to the community. Medical students who elected to be incorporated into this project with the assistance of patients with chronic diseases to lifestyle changes.

Each student will work closely with a family doctor who finds for patients who need and want it accompanied by a change he introduced them and guide him on health status, medication and change the desired objectives.

In the program students will receive guidance on healthy lifestyle and support a patient to perform health changes in theoretical and practical. Training sessions will be held periodically, close supervision and guidance, counseling and cross-fertilization and updates from the scientific literature.

The student will meet with patients and support them to make a lifestyle change in favor of health

Eligibility Criteria:
Inclusion Criteria:

* aged 20-80
* male or female
* Chronically ill patients who suffers from hypertension, diabetes, obesity, stable heart disease, high blood lipids, etc
* spotted by a family doctor needed a change in lifestyle to improve his health
* expressed his desire to participate process consulting and support.

Exclusion Criteria:

* patients aged less than 20 or more than 80 years
* patients with complex medical problems and unstable heart disease
* patients who are not interested in supporting.
Evaluation of FFR, WSS, and TPF Using CCTA

To assess the feasibility of CT-derived computed fractional flow reserve (FFRCT), wall shear stress and total plaque force on coronary atherosclerotic plaque and to collect the preliminary data to apply those parameters for the prediction of clinical outcomes in patients with coronary artery stenosis.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive patients with available CCTA within 3 months of invasive angiography and invasive imaging methods (IVUS or OCT)

Exclusion Criteria:

* Poor CT images (unable to reconstruct 3 dimensional coronary artery model)
Trends in Trans-Fatty Acid Intake Between 1980 and 1997

To examine trends in trans-fatty acid intake by using newly available nutrient data to recalculate 24 dietary recalls from the Minnesota Heart Survey.

BACKGROUND:

In recent years concern has arisen about the potential health hazards of trans-fatty acids in the American diet. Dietary intake of trans-fatty acids has been linked to unhealthy shifts in serum lipid profiles and to coronary heart disease (CHD) in a number of studies. Although several studies have estimated intakes of trans-fatty acids in U.S. populations, presently data is lacking regarding trends in intake of trans-fatty acids in the population. Furthermore, it is unclear how trends in intake of trans-fatty acids may be related to changes in other dietary and non-dietary CHD risk factors and CHD mortality.

DESIGN NARRATIVE:

The study used newly available nutrient data to recalculate dietary data collected as part of the Minnesota Heart Survey (MHS) to examine trends in intake of trans-fatty acids. The MHS was an ongoing observational epidemiologic study of trends in risk factors and cardiovascular morbidity and mortality among independent cross-sectional probability samples of the Minneapolis-St. Paul, Minnesota, metropolitan area. Surveys were conducted in 1980-1982, 1985-1987, 1990-1992 and 1995-1997. Diet was among the CVD risk factors measured as part of each survey. In this research, 24-hour dietary recalls collected from MHS participants were recalculated using an updated food and nutrient database that included trans-fatty acid values (16:1, 18:1, 18:2, and total). Intake estimates resulting from recalculation were analyzed to examine temporal trends in trans-fatty acid intake between 1980 and 1997, and to examine the relationship of temporal trends in trans-fatty acid intake to temporal changes in other dietary and non-dietary CHD risk factors and changes in CHD mortality. The MHS data provided a unique opportunity to examine a dietary constituent only recently recognized as a potential risk factor for CHD.

Eligibility Criteria:
No eligibility criteria
ESP Block vs FIB in Patients Undergoing Hip Arthroplasty

The aim of this study is to compare between the analgesic efficacy of ESP block and FIB in patients undergoing hip arthroplasty.

Hip arthroplasty surgery is usually associated with severe postoperative pain. Several modalities are usually used for postoperative analgesia in these patients, those include; intravenous analgesia, neuraxial analgesia and peripheral nerve blocks.

Peripheral nerve blocks have several advantages such as; potent analgesia, lower motor impairment and minimal systemic complications.

Lumbar plexus block and supra-inguinal fascia iliaca block (FIB) are the most commonly performed peripheral nerve blocks for hip surgeries.

Fascia iliaca block is one of the most common techniques for pain control after hip surgeries; it can be regarded as an anterior approach of the lumbar plexus. It provides analgesia through spread of local anaesthetic to the femoral and lateral cutaneous femoral nerves.

Ultrasound guided erector spinae plane (ESP) block is a recent regional anesthetic technique. It was first described in 2016 for acute and chronic thoracic pain management. It is a paraspinal fascial plane block that provides analgesia through injecting local anesthetic drugs to block the ventral and dorsal rami of spinal nerves in the paravertebral area.

To the best of the investigators knowledge, the use of ESP block in hip surgery was only investigated in one study and few case reports. Therefore, further randomized controlled studies are needed to prove this hypothesis.

This study aims to investigate the efficacy of ESP block in hip replacement compared to the supra-inguinal FIB.

The investigators hypothesize that erector spinae block may provide better postoperative analgesia than fascia iliaca block, since erector spinae block provides analgesic cover for the entire lumbar plexus rather than just peripheral nerves provided by fasicia iliaca.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 65 years
* ASA grade I to II
* Patients scheduled for hip replacement surgeries under subarachnoid block (SAB) e.g. hip hemi-arthroplasty, total hip arthroplasty

Exclusion Criteria:

* Patient refusal
* Age below 18 or above 65 years.
* ASA grade III to IV
* Patients with known allergies to any of the drugs used.
* Contraindication to SAB eg. Coagulopathy, infection at the injection site, severe cardiopulmonary disease, diabetic or other neuropathies.
* Patients receiving opioids for chronic analgesic therapy
* Inability to comprehend visual analogue scale (VAS)
* Infection at site of erector spinae or fascia iliaca block.
* Body mass index \>35 kg/m2
Pomaglumetad Effects on Glutamate Biomarkers

The study will evaluate the effects of the mGluR2/3 partial agonist LY2140023 (Pomaglumetad Methionil, "POMA") at selected doses on ketamine-stimulated glutamate release in prefrontal cortex as measured by pharmacoBOLD fMRI (also termed resting BOLD fMRI).

This study evaluates the effects of POMA at selected doses on ketamine-stimulated glutamate increase in the prefrontal cortex hypothesized to simulate the synaptic dysregulation that occurs endogenously in the pathogenesis of schizophrenia. The purpose of this is: 1) to determine whether the low dose (40 mg BID) utilized in recent (failed) clinical trials is sufficient to engage the primary target and 2) whether a higher (160 mg BID) dose, representing the maximum tolerated dose of POMA, engages the target to a greater degree. This study will further validate pharmacoBOLD as biomarker of mGluR2/3 target engagement, permitting its future use in other glutamatergic drug development.

Eligibility Criteria:
Inclusion Criteria:

* Medically healthy
* Capable of understanding the study procedures and able to provide informed consent
* Men and women must agree to use a reliable method of birth control during the study. Women who are post-menopausal or otherwise not of childbearing potential are also eligible

Exclusion Criteria:

* Current or past Axis I psychiatric history
* Positive urine toxicology
* History of recreational ketamine use, recreational PCP use, or an adverse reaction to ketamine. Subjects who have participated in prior research ketamine studies will be eligible. Subjects can have infusions not more frequently than biweekly, and not more than 1/month on average, therefore subjects entering the study will need to wait one month if they had a single infusion and 6 weeks if they have had two closely spaced infusions.
* History of first-degree relative with schizophrenia
* History of violence
* Presence or positive history of significant medical illness
* Presence or positive history neurological illness or any other disease/procedure/accident/intervention association with significant injury to or malfunction of the central nervous system (CNS) or history of significant head injury
* Pregnancy or breast feeding
* Metal implants, pacemaker, other metal or paramagnetic objects contained within the body
* Medicinal patch, unless removed prior to MRI scan
* Currently taking any psychotropic medication, including antidepressant medications, benzodiazepines, antipsychotic medications, mood stabilizers, anti-epileptic medications and stimulants.
* Claustrophobia
* Suicidal ideation with intent or plan in the 6 months prior to screening
* Weight \> 86.95 kg (191.2 lbs)
* Subthreshold pharmacoBOLD response during screening ketamine infusion