cyrilzakka/clinical-trials huggingface dataset:
A Comparison of the Effects on Cardiovascular Risk Factors of Korean and American Dietary Profiles

The primary aim of this study is to compare, in a group of at-risk individuals, the role of three dietary patterns on indices of Cardiovascular Disease (CVD) risk: a) the recommended Korean pattern; b) the typical American diet, based on national dietary intake surveys; and c) the 2010 DGA diet pattern. A secondary aim will be to assess the effects of each diet on intestinal microbiota and on inflammatory biomarkers.


Eligibility Criteria:
Inclusion Criteria:

* Non Asian-American men and women between the ages of 25-65 years
* Body Mass Index (BMI) ≥ 25 and ≤ 38 kg/m2
* Fasting LDL-cholesterol ≥ 130 mg/dL
* Willingness and ability to make scheduled appointments at clinical site as required by study protocol

Exclusion Criteria:

* Major aversions to Korean foods
* Known food allergies that would interfere with study protocol
* Use of cholesterol-lowering medication or dietary supplements
* Use of blood pressure medications
* Use of prebiotics or probiotics in the last 3 months
* Received medication for bacterial infection (antibiotic) in the last 3 months
* Regular use of fiber supplements or laxatives
* Conditions requiring ongoing medical care and/or medication, including kidney, liver, gastrointestinal or endocrine disorders.
* Regular tobacco use within 6 months prior to the start of the study
* History of eating disorders or other dietary patterns which are not consistent with the dietary intervention (e.g., vegetarians, very low fat diets, high protein diets)
* Voluntary or involuntary weight loss of 10% of body weight within the last 12 months
* Self-report of alcohol or substance abuse within the past 12 months
* Donated blood during the 8 week period prior to the study
* Other medical, psychiatric, or behavioral factors that in the judgment of the Principal Investigator may interfere with study anticipation or the ability to follow the intervention protocol
Efficacy of Exparel (TM) on Post-operative Pain After Laparoscopic Gastric Bypass Using Circular EEA Stapler

This will be a comparative study between two cohorts of patients undergoing Roux-en-Y Gastric bypass. One cohort (75 patients) will receive FDA approved Exparel® (liposome bupivacaine injection solution) injections intra-operatively at time of incision site closure. The control cohort (75 patients) will receive 0.25% bupivacaine injection solution at the time of incision site closure. The medication for the control group is our current standard of care. The primary end point is post-operative pain at 24 and 48 hours measured by the Visual Analog Scale (VAS). Comparison will be made between cohorts. All subjects enrolled in the study will be evaluated per nursing protocol with the verbal numerical analog scale. At 24 and 48 hours a member of the research team will administer a 2-part questionnaire containing the VAS and the Revised American Pain Society Post-Operative Questionnaire (APS-POQ-R). The latter is validated for assessment of the patient's experience of pain and it hindrance to daily activity in the post operative period.

The study will include up to 150 patients, and will consist of two cohort. The study cohort will include 75 patients who receive intraoperative Exparel® injections at the incision locations in addition to our standard multimodality post-operative analgesia. The control arm will include 75 patients who meet inclusion criteria but receive standard 0.25% bupivacaine and our standard multimodality post-operative analgesia. Patients will be randomized by REDCap™ database system in collaboration with Cleveland Clinic Pharmacy to receive either Exparel® or the control medication (0.25% Bupivacaine). Consent from patients will be obtained and documented by a dedicated research personnel prior to any enrollment.

Eligibility Criteria:
Inclusion Criteria:

* bariatric surgery patients
* laparoscopic roux-en-y gastric bypass
* use of EEA stapler anastomosis

Exclusion Criteria:

* age \<18 years
* previous history of roux-en-y gastric bypass
* patients undergoing other bariatric procedures
* pre-operative opioid analgesics
The Effect of Leg Position on the Sciatic Nerve on Sonogram

Little is known about which posture of lower extremity makes it easier to access to the sciatic nerve. In this study, the investigators aimed to identify the most appropriate positioning of the lower extremity during anterior-approach ultrasound-guided sciatic nerve block.


Eligibility Criteria:
Inclusion Criteria:

* ASA PS 1-3
* patients undergoing knee surgery requiring peripheral nerve block

Exclusion Criteria:

* patients who refuse to participate in the study
* BMI \> 40 kg/m2
* patients who have congenital abnormality on leg
* patients who have surgery or trauma on hip/knee
* patients who cannot move freely due to the contracture
* patients who are judged ineligible by the medical staff to participate in the study for other reasons
Cardiometabolic Risk Factors Registry

CARFARE (CARDIOMETABOLIC RISK FACTORS REGISTRY) is a registry done in the context of a cardiovascular primary prevention program of the Cardiometabolic Unit Officia of the Cardiology Department of the Austral University Hospital. The structured and sequential evaluation include measurement of anthropometric parameters (body mass index, BMI), laboratory with metabolic profile, baseline electrocardiogram, blood pressure (BP) measurement, arterial stiffness, subclinical atherosclerosis screening in the carotid and ileo-femoral territories using echo-doppler, echocardiogram, and ergometry test.


Eligibility Criteria:
Inclusion Criteria:

* Age \>18 years old.

Exclusion Criteria:

* Previous cardiovascular and/or cerebrovascular event
* stable chronic angina
* advanced chronic kidney disease (Stage IV or V)
* cancer
A Study to Investigate the Effects of Ketoconazole on LBH589 in Patients With Advanced Solid Tumors

The primary purpose of this open-label study is to investigate the interaction of ketoconazole, a liver enzyme inhibitor, on oral LBH589 in adult patients with advanced solid tumors. The extension phase of the study will evaluate the safety and efficacy of LBH589 in patients with advanced solid tumors.


Eligibility Criteria:
Inclusion criteria:

* Patients with histologically confirmed solid tumors or non-Hodgkin's lymphoma with progression on prior standard therapies.
* Eastern Cooperative Oncology Group (ECOG) performance status of ≤ 2
* Adequate kidney function and laboratory values

Exclusion criteria:

* Patients who have received chemotherapy, any investigational drug, undergone major surgery, or received wide field radiotherapy less than 4 weeks ago
* Patients who had a heart attack or have unstable angina within past 6 months
* Heart disease including congestive heart failure and uncontrolled high blood pressure
* Liver disease, abnormal gastrointestinal (GI) function or ongoing diarrhea
* Use of any anti-cancer therapy, including radiation therapy, or certain drugs while on study
* Female patients who are pregnant or breast feeding.

Other protocol inclusion/exclusion criteria may apply.
Pharmacokinetic Study of Ceftaroline Fosamil/Avibactam in Adults With Augmented Renal Clearance

To evaluate the pharmacokinetic (PK) profiles of ceftaroline and avibactam in adults with augmented renal clearance (ARC).

To evaluate the single-dose pharmacokinetic (PK) profiles of ceftaroline and avibactam following intravenous (IV) administration of ceftaroline fosamil/avibactam ("CXL") in adults with augmented renal clearance (ARC).

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults ≥ 18 and ≤ 55 years old
* Augmented renal clearance, defined as:

  * Estimated CrCl ≥ 115 mL/min (calculated using modified Cockcroft-Gault, before the measured 8-hour urine collection)
  * Measured CrCl ≥ 140 mL/min (from an 8-hour urine collection)
* Hospitalized and diagnosed with SIRS, defined by at least 2 of the following:

  * Temperature (oral, rectal, tympanic, or core) \> 38.5°C or \< 35.0°C
  * Heart rate \> 90 beats/min
  * Respiratory rate \> 20 breaths/min or PaCO2 \< 32 mmHg
  * Leukocytosis (\> 12,000 white blood cells \[WBC\]/mm3), leukopenia (\< 4000 WBC/mm3), or bandemia (\> 10% immature neutrophils \[bands\] regardless of total peripheral WBC)
* Requires indwelling urinary bladder catheter per standard of care (through the end of the 8-hour urine collection)

Exclusion Criteria:

* History of any known hypersensitivity or allergic reaction to cephalosporins or any β-lactam antimicrobial (eg, penicillins)
* History of chronic kidney disease, hemodialysis, or peritoneal dialysis; or history of acute renal replacement therapy (eg, hemodialysis, hemofiltration) associated with current illness
* Suspected rhabdomyolysis or creatine kinase \> 10,000 U/L
* Significant anemia defined as hemoglobin \< 9 g/dL or hematocrit \< 27%
* Transfusion of packed red blood cells (PRBC) or whole blood within 24 hours of study drug infusion or anticipated need for a transfusion before the last PK blood sample is collected
* If female, currently pregnant or breastfeeding
The Effect of the Rubber Hand Illusion on Sensory Thresholds

The rubber hand illusion (RHI) causes a change in body perception and awareness as a result of the integration of simultaneously perceived visual and tactile stimulation. In the rubber hand illusion (RHI), which was first described in 1998, a realistic hand model is perceived as a part of the body and body awareness is impaired. In the RHI, the participant's real hand is positioned behind a screen so that it is out of sight; The rubber model hand is placed in the field of vision and in the appropriate position with the real hand. Brush is applied simultaneously to the same parts of the real and rubber hands. He/she perceives the rubber hand as his own and the brush starts to feel as if it is being rubbed into his own hand. This method, which causes the illusion of body belonging, has been defined as the rubber hand illusion. During the rubber hand illusion, increased activity was observed in the ventral premotor cortex, infraparietal cortex and cerebellum in functional MRI. It is suggested that this phenomenon occurs with the integration of interrelated visual, tactile and proprioceptive senses reaching the premotor cortex.

Quantitative sensory tests are standardized subjective clinical sensitivity tests that require the collaboration of the person to be examined. In the tests, calibrated stimuli are applied to capture perception and pain thresholds, thus providing information about sensory thresholds.

The impairment of body perception caused by RHI contributes to the multi-faceted understanding of sensory perception, higher-level cognitive processes, brain mapping and functions. In the studies; It has been suggested that the conflict between visual and proprioceptive sensory information created during the rubber hand illusion is resolved by the attenuation of somatosensory input at the cortical level.

As far as we know, tactile sensory threshold from quantitative sensory tests, two-point discrimination from cortical senses, pressure pain threshold measured by the algometer, and vibration threshold variation during and after rubber hand burning, which causes changes in body perception, have not been studied before. In this study, the relationship between the RHI phenomenon and sensory thresholds will be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* Healthy
* 18-65 years old age

Exclusion Criteria:

* Neuropathy
* Presence of any known neurological or psychiatric disease
* Inability to cooperate with the tests to be performed
* Amputation and nerve damage in the upper extremities
* Upper extremities dysfunction due to nerve damage
Physiological Examination of New Fighting Clothing During Exposure to Exercise Under Hot Conditions

The use of fighting clothing under extreme heat conditions during rest and exercise, compromises the body's ability to maintain temperature within the narrow physiological range needed for regular function, and might lead to heat injury. Beside working and fighting clothing, the fighters also wear vests used for protection and equipment carrying, which leads to substantial reduction in effective dissipation area from the central region of the body. This fact is most substantial during exercise which increases metabolic heat production rate and leads to heat accumulation and rise in body temperature. Therefore the development of new textile technologies to allow rapid cooling during intervals is of great importance.

This study is designed to physiologically examine new textile solutions, by evaluating the physiological stress induced during exercise under mild heat conditions.


Eligibility Criteria:
Inclusion Criteria:

* Men
* Formerly fighters
* Healthy
* Without prior diseases including heart, vessel, respiratory and metabolic diseases or known use of medications
* experience in using fighting clothing
* VO2max \> 50 ml/kg/min

Exclusion Criteria:

* Incapacity to fulfill inclusion criteria
Effect Of Azithromycin in Women at Risk of Preterm Labour

The aim of this study is to evaluate the benefit of the addition of azithromycin to standard treatments to prolong pregnancy in women having intact membranes and is at risk of or in preterm labour.

Study Design:

Comparative controlled study.

Study site :

The study will be conducted at the department of Obstetrics and Gynecology at Beni-Suef University Hospital.

Study period:

The study will be conducted from 15th September 2022 till reaching the target number.

Study Population The control group will include pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy.

The test group will involve pregnant women, having intact membranes and are at risk of or in preterm labour, administrating the standard treatments for prolongation of pregnancy plus prophylactic azithromycin.:500 mg PO once for 5 days every month.

Sample size:

The sample size was determined using G\*Power Version 3.1.9.2 \[computer software\] (Franz Faul, Kiel, Germany),Power analysis for a chi-square test was conducted in G-POWER to determine a sufficient sample size using an alpha error of probability of 0.05, power of 0.95, a medium effect size (w = 0.3) and 1 degree of freedom. Based on the aforementioned assumptions, the desired sample size is 145. By calculating 25% drop out, so the least total sample size in both groups will be 200 patients (95 patients in each group).

Each patient will be subjected to:

Thorough history taking and examination. Investigations: Complete blood picture (CBC), bleeding profile , kidney function tests and liver function tests will be done.

Ultrasound: 2D Ultrasound assessing :

It will be carried out in Gynecology and Obstetrics department in Beni-Suef University Hospital, ultrasonography criteria: Ultrasound biometry of the fetus is now the gold standard for assessing fetal growth. The measurements most commonly used are the biparietal diameter, head circumference, abdominal circumference and femur length

Eligibility Criteria:
Inclusion Criteria:

* 24 \< Pregnancy \<37 weeks of gestation.
* Threat or history of preterm labour.
* Preterm labour itself (Non established)

Exclusion Criteria:

* antibiotics use within 14 days (except for pericerclage prophylaxis, or streptococcus B prophylaxis);
* PPROM; and fetal extraction required \<37 weeks.
* Current or past history of medical diseases (Diabetes Milletus, Hypertension, Systemic Lupus Erythematosus, Cardiac diseases, etc ).
* Adverse perinatal outcome due to abdominal trauma.
* Structural fetal anomalies detected during anomaly scan.
* Allergy to Azithromycin.
In Vivo Confocal Endomicroscopy of the Brain

The purpose of the study is to test the feasibility of obtaining interpretable in vivo endomicroscopy images which can be compared with traditional histopathology.

Hypothesis: That a rigid confocal endomicroscope can be used during neurosurgery to provide in vivo histology that enables differentiation of tumour tissue from normal adjacent brain tissue.

Confocal endomicroscopy is a medical imaging modality that allows real-time microscopy to be performed on living tissue in vivo. It is already in clinical use in the fields of gastroenterological endoscopy, laparoscopy, dermatology, gynecology and respiratory medicine. This study represents the first time that confocal endomicroscopy will be evaluated for intraoperative imaging in neurosurgery.

The procedure involves a small endoscope which is placed gently into contact with the brain, providing significant in vivo magnification on a scale similar to that obtained by the pathology laboratory microscope. The captured confocal images will be compared with corresponding histology (tissue that is being removed as part of the indicated neurosurgical procedure). The images will be visually compared among each other and with histology images to detect possible clinically relevant information.

Eligibility Criteria:
Inclusion Criteria:

* All patients with neurosurgical pathology requiring surgery in which tumor resection might be evaluated by using biopsy.

Exclusion Criteria:

* Pregnant women
* Inability to give informed consent
* History of allergy to fluorescein
* Patients on beta-blockers or ACE inhibitors
Measurement of Gastric Band Stoma Diameter

The purpose of this study is to correlate accurate fluoroscopic measurement of gastric band stoma diameter with patient symptoms for optimal band stoma adjustment. Administration of a barium tablet to gastric band patients with dilute liquid barium allows the accurate measurement of the band stoma diameter. The technique is quick, easy to perform, and eliminates magnification error intrinsic to fluoroscopy. The study data suggests the optimal calibrated gastric band stoma diameter is 3.0 mm. The accurate fluoroscopic measurement of gastric band stoma diameter can optimize band stoma adjustment and improve patient outcomes.

Ten patients presenting for an upper GI series with laparoscopically placed gastric bands were enrolled after informed consent. After a standard upper GI evaluation, oral administration of a standard 13 mm barium sulfate tablet was performed and swallowed with dilute liquid barium during fluoroscopic monitoring. A spot radiograph was obtained once the barium tablet was in the gastric pouch and the dilute liquid barium was passing through the gastric band stoma. Post-processing software used the longest radiographic dimension of the 13 mm barium tablet as the size reference to calibrate measurement of the gastric band stoma diameter.

Eligibility Criteria:
Inclusion Criteria:

* eating
* s/p LAP BAND placement

Exclusion Criteria:

* immediately post operative
* s/p LAP BAND placement
* significant abnormality found on preceding standard upper GI series
Comparison of Two Urostomy Bags (2-piece).

Coloplast A/S has developed a new, improved 2-piece product for people with urostomies.

The 2-piece product is a part of a new product family, under the brand name SenSura. The aim of this investigation is to see how the urology product is perceived and how it performs against another 2-piece product from ConvaTec. The device 'ConvaTec 2-piece combihesive Natura' is selected as the comparative product because of its similarity to SenSura 2-piece product.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years old,
* Be able to complete a written consent form
* Be able to fill in the Case Report Form
* Have a urostomy with a diameter of 33 mm. or less.
* Have had the urostomy for 3 months or more.
* Use a 2-piece convex (or convex light) normally.
* Be able to use SenSura URO 2-piece product
* Be able to use ConvaTec, 2-piece product
* Be able to handle the product themselves (application, removal and emptying),

Exclusion Criteria:

* In order to be enrolled in the clinical investigation, the subjects must not:

  * Need to use an ostomy belt
  * Be currently suffering from any dermatological problems, needing special treatment, on the peristomal skin
  * Being treated with chemo- or radiation therapy,
  * Be hospitalized during study enrollment, or have a hospitalization or significant surgery planned during the 4-week study period, or
  * Be pregnant or breast-feeding.
Dalteparin in Preventing Blood Clots in Patients With Lung Cancer

RATIONALE: Anticoagulants, such as dalteparin, may help prevent blood clots from forming in patients with lung cancer. It is not yet known whether dalteparin is effective in preventing blood clots in patients with lung cancer.

PURPOSE: This randomized phase III trial is studying how well dalteparin works in preventing blood clots in patients with lung cancer.

OBJECTIVES:

Primary

* Determine whether the addition of dalteparin results in improved survival.

Secondary

* Determine venous thrombotic event-free survival and metastasis-free survival.
* Determine serious adverse events in patients treated with this drug.
* Determine the toxicity of this drug in these patients.
* Determine the quality of life, breathlessness, anxiety, and depression in patients treated with this drug.
* Determine the cost effectiveness and cost utility of this drug.

OUTLINE: This is a multicenter study. Patients are randomized to 1 of 2 treatment arms.

* Arm I (control): Patients receive anticancer treatment considered appropriate by the local medical team.
* Arm II: Patients receive anticancer treatment considered appropriate by the local medical team. Beginning before the start of the first definitive anticancer treatment, patients receive dalteparin subcutaneously daily for up to 24 weeks.

Quality of life, anxiety, depression, and dyspnea are assessed at baseline, at 12 and 24 weeks, and then at 9 and 12 months.

After completion of therapy, patients are followed at 9 months, 1 year, and then every 6 months for at least 2 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histopathological or cytological diagnosis of primary bronchial carcinoma (small cell or non-small cell lung cancer) within the past 6 weeks
* No other intrathoracic tumors (e.g., carcinoid tumor, mesothelioma, lymphoma, or lung metastases from another primary site)
* No clinically apparent brain metastases

PATIENT CHARACTERISTICS:

* ECOG performance status 0-3
* Platelet count ≥ 100,000/mm³
* Serum creatinine ≤ 150 µmol/L
* Willing and able to self-administer dalteparin by daily subcutaneous injection or have it administered by a caregiver
* Not pregnant or nursing
* Fertile female patients must use effective contraception (if sexually active)
* No hemorrhagic stroke within the past 3 months
* No known bleeding disorder
* No hemoptysis of CTC ≥ grade 2 (i.e., symptomatic hemoptysis requiring medical intervention)
* No central venous catheter requiring the use of thromboprophylaxis
* No known hypersensitivity to dalteparin, heparin, or other low molecular weight heparins (e.g., history of confirmed or suspected immunologically mediated heparin-induced thrombocytopenia; acute gastroduodenal ulcer; or subacute endocarditis)
* No prior illness likely to interfere with study treatment or comparisons

PRIOR CONCURRENT THERAPY:

* No prior treatment likely to interfere with study treatment or comparisons
* More than 12 months since prior and no concurrent therapeutic anticoagulation
* No concurrent ketorolac (Toradol®)