cyrilzakka/clinical-trials huggingface dataset:
The Effects of Weight Loss on Neuroadrenergic Function

Elevated subconscious nervous system activity is a characteristic of the obese state and contributes importantly to the risk of heart disease and diabetes. This project will compare sympathetic nervous system activity and function in a group of obese persons with differing levels of sugar tolerance (normal, impaired and type 2 diabetic). Inter-relationships with insulin action, blood pressure, heart and kidney function will be determined before and after a 4-month weight loss and 3-month weight loss maintenance program.

It is hypothesized that the transition from normal sugar tolerance to impaired sugar tolerance to type 2 diabetes will be accompanied by escalating sympathetic nervous system dysfunction. Furthermore, that weight loss will favorably improve sympathetic function, with greatest benefits occurring in those subjects who are insulin resistant with high blood insulin concentration.

The twin epidemics of obesity and diabetes represent a major public health problem worldwide. There is a growing body of evidence to suggest that autonomic dysfunction, comprising elevated sympathetic nervous system (SNS) activity and blunted sympathetic neural responsiveness plays a role in both the pathogenesis and target organ complications of obesity and diabetes. The proposed project will undertake a detailed comparative analysis of neuroadrenergic function along the diabetes continuum, its inter-relationship with insulin sensitivity and secretion, and target organ function, and the benefits of active weight loss and weight loss maintenance within different strata of metabolic risk.

Eligibility Criteria:
Inclusion Criteria:

Men and postmenopausal women (n=120), untreated, weight-stable, non-smoking, aged 45-65 years, BMI 27-45 kg/m2, will be recruited. Glucose tolerance status will be determined by a 75-g oral glucose tolerance test (OGTT), using WHO criteria (53): normal glucose tolerance, fasting plasma glucose \< 7.0 mmol/L and 2-h plasma glucose \< 7.8 mmol/L; IGT, fasting plasma glucose \< 7.0 mmol/L and 2-h plasma glucose \> 7.8 and \< 11.1 mmol/L; T2D, fasting plasma glucose \> 7.0 mmol/L or 2-h plasma glucose \> 11.1 mmol/L. Hyper-insulinemia will be defined as an insulin area under the curve during OGTT \> 8000 mU/L ∙ min-1 and hypo-insulinemia as \< 8000 mU/L ∙ min-1.

Exclusion Criteria:

Prior history of cardiovascular disease (previous myocardial infarction, angina, stroke, heart failure, secondary hypertension), renal (serum creatinine \>0.12 mmol/L or estimated GFR \<60 ml/min/1.73 m2) or hepatic disease or diseases which may affect measured parameters (e.g. thyroid disease); severe hypertension; a history of surgical weight loss; CPAP therapy; and \>4 alcoholic drinks/day. T2D individuals with moderate hyperglycemia (HbA1c \>9%) will be excluded so that hypoglycaemic pharmacotherapy may be instituted (54). Participants will be sought through newspaper advertising and poster displays in primary health care centres (General Practices). Newly diagnosed T2D subjects
Respiratory Oscillometry for the Prediction of Bronchopulmonary Dysplasia

The goal of this observational study is to learn about the correlation between respiratory system reactance, as assessed by respiratory oscillometry, and respiratory outcomes in preterm infants born before 32 weeks of gestation. The main question it aims to answer is if the reactance z-score at 7 postnatal days adds to relevant clinical factors in the prediction of bronchopulmonary dysplasia. Participants will receive respiratory oscillometry measurements at 7 ± 2 postnatal days.


Eligibility Criteria:
Inclusion Criteria:

* born before 32 weeks post-menstrual age

Exclusion Criteria:

* congenital abnormalities
* Inherited disorders of metabolism
Scripps Tumorgraft Study

Study the genetic traits of cancerous tissues and to help improve cancer treatment by developing tumor models for studying new cancer drugs.


Eligibility Criteria:
Inclusion Criteria:

* Age 21 or over
* diagnosis of a solid tumor malignancy, either resectable or metastatic or a hematologic malignancy
* cognitively and emotionally able to give informed consent

Exclusion Criteria:

* Under age 21
* Not cognitively or emotionally able to give informed consent
Postoperative BMI Changes and Functional Outcomes in Knee and Hip Arthroplasty

PURPOSE Obesity poses challenges to preoperative mobility and functional recovery for arthroplasty patients, yet postoperative weight loss remains elusive. This study aims to investigate postoperative weight changes and their impact on functional scores following knee and hip arthroplasty, exploring factors influencing these changes.

METHODS A total of 459 knee and hip arthroplasty cases with a 2-year follow-up were analyzed. BMI and Oxford scores were tracked, alongside factors including comorbidities, corticosteroid use, physiotherapy, and unilateral vs. bilateral surgery.

EXPECTED OUTCOMES Based on the study's design and the data available, we anticipate observing the impact of changes in patients' BMI on clinical scores as an independent variable. Additionally, we aim to elucidate the effects of comorbidities, corticosteroid use, physiatrist follow-up, and the type of surgical procedure on both BMI and clinical outcomes. Through this analysis, we expect to gain a comprehensive understanding of how these factors interplay to influence postoperative recovery and overall patient health.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent primary TKA and THA with a 2-year follow-up were included

Exclusion Criteria:

* Patients who underwent bariatric surgery before or after the surgery
* Incomplete 2-year follow-up
* Whom BMI or Oxford scores could not be accessed
Whole Body Magnetic Resonance Angiography With Subsystolic Venous Compression

To investigate the diagnostic performance of whole body magnetic resonance angiography (WB-MRA) using subsystolic venous compression of the thigh.

WB-MRA is an examination that can evaluate the arteries from head to feet. Timing of the injected bolus of contrast medium can be difficult, especially in the legs. As the result of the WB-MRA depends on the contrast medium only being in the arteries at the time of examination, the use of venous compression is a possible way of overcoming the problem of early venous filling, that can hamper the diagnostic value of the examination. Venous compression is performed with a blod pressure cuff around the thighs. It is inflated to subsystolic pressure (45 mm Hg). This elevated pressure leads to filling of the lower leg arteries and late venous filling.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic lower extremity ischemia (claudication, ischemic wounds)
* Referred to digital subtraction angiography (DSA)

Exclusion Criteria:

* Renal insufficiency (GFR \< 30 ml/min)
* Contra-indications for MRI-examination (claustrophobia, metal-implants, pacemaker)
* Dementia
* Pregnancy/lactation
* Allergy to gadolinium based MRI contrast agents
* Acute disease
Aesthetic Outcome of Layered Closure vs. Layered Closure Followed by 2-Octyl Cyanoacrylate

Following skin surgeries on the head and neck, several surgeons use a type of surgical glue (such as Dermabond) as a final layer on the top of wound. This glue is thought to seal the wound. Up until this point, there is limited data about the exact advantages or disadvantages of using this glue. We wish to determine if there is a difference in the cosmetic outcome of the scar when the glue is applied compared to when the glue is not applied. In addition, we want to determine if patients prefer to care for a wound with or without the glue.

Sutures are the standard of care in repairing cutaneous wounds. The majority of surgical reconstructions following a Mohs micrographic surgery and standard surgical excisions require two layers of sutures: a deep (subcutaneous) layer and a superficial (cuticular) layer.

Alternatively, skin adhesives, such as 2-octyl cyanoacrylate (commercially available as "Dermabond"), have been used successfully in lieu of the outer layer of sutures. Cosmetic outcomes with 2-octyl cyanoacrylate have been shown to be equivalent to sutured wounds, perhaps with a lower infection rate. However, wounds repaired with 2-octyl cyanoacrylate may have a higher dehiscence rate.

Recently, surgeons have been using 2-octyl cyanoacrylate, in addition to dissolvable sutures. This is thought to combine the advantages of 2-octyl cyanoacrylate, including easier wound care and lower infection rate, with the lower dehiscence rate of sutures.

A previous study by Zhuang et al found no difference in wound cosmesis between deep sutures supplemented by 2-octyl cyanoacrylate compared with layered closure with 5-0 fast-absorbing gut suture, with the exception of inferior scar pigmentation with 2-octyl cyanoacrylate.1 Several studies likewise found no significant differences between 2-octyl cyanoacrylate versus sutures in repairing cutaneous wounds.

To our knowledge, no study has been conducted directly comparing closure (2 layers) versus closure supplemented by 2-octyl cyanoacrylate (3 layers). We hope that our study will provide new insight into this aspect of cutaneous surgery.

Eligibility Criteria:
All patients scheduled for cutaneous surgical procedures with one of the study investigators at the UC Davis Dermatology Clinic will be screened for eligibility.

Inclusion Criteria:

* 18 years of age or older
* Able to give informed consent themselves
* Patient scheduled for cutaneous surgical procedure on the face or neck with predicted primary closure.
* Willing to return for follow up visit

Exclusion Criteria:

* Incarceration
* Under 18 years of age
* Pregnant women
* Unable to understand written and oral English.
* Wounds with predicted closure length less than 3 cm

None of these special populations will be included.
Influence of Vitamin D Treatment on Multi-systemic Functions in Young Men With Vitamin D Deficiency Due to Work Conditions

Vitamin D has multiple systemic effects: bone and calcium metabolism, muscle function, insulin responsiveness, body-composition regulation, cell differentiation, and the immune system. Proper status of vitamin D is found to be related to risk reduction in hypertension, cardiac and vascular diseases, autoimmune diseases, and others. Furthermore, vitamin D supplementation resulted in improved endothelial function. Limited sun exposure may lead to vitamin D deficiency, and it may be assumed that modern life styles lead to a lack of sun exposure. Long work-days may be the primary risk factor for vitamin D deficiency. The purpose of this research is to study the effect of vitamin D treatment on multi systemic functions in young healthy men with vitamin D deficiency due to working conditions.

The study has 2 stages: first stage would be survey of 400 employees, who will fill out a questionnaire to identify occupational and demographic risk factors, a nutritional questionnaire, and data from periodic checkups will be collected. Participants will sign a consent form for vitamin D level determinations, and for freezing blood samples. From this survey, the participants that have vitamin D deficiency (25(OH)D levels \< 20 ng/ml) will continue to the second stage of the study - administration of vitamin D or placebo. Participants in the interventional study will sign an additional consent form. Length of follow-up: one year. All parameters will be tested at 0, 6, and 12 months.

Eligibility Criteria:
Inclusion Criteria:

* Healthy men between 20-65 years old
* For stage 2: baseline 25(OH)D levels \< 20 ng/ml

Exclusion Criteria:

* Liver dysfunction
* Kidney dysfunction
* Patients with unbalanced chronic diseases
* Regular use of medications that lower serum vitamin D levels, or which interfere with intestinal vitamin D absorption
Teleconference Fatigue Management for People With Multiple Sclerosis

Approximately 60% of individuals with multiple sclerosis (MS) describe fatigue as their most disabling symptom. Energy conservation education involves teaching people with MS different strategies to manage fatigue and reduce its impact on daily life. Despite growing evidence of the effectiveness of face-to-face energy conservation education, not all people with MS are able to access these programs. The purpose of this project is to test the effectiveness and efficacy of a teleconference-delivered energy conservation education program for people with MS. The primary goals of the project are to reduce the impact of fatigue on participants' everyday lives, reduce fatigue severity, and improve quality of life. Secondary goals are to increase self-efficacy for managing fatigue and increase the number of energy conservation strategies used. The study will employ a randomly allocated two group time series design with a wait-list control group, which is one type of randomized control trial. A total of 181 people with MS will be recruited through direct mailing and advertising. The program will be delivered by telephone teleconference by a licensed occupational therapist. Outcome measures will be administered over the telephone by a research assistant before and after the program, at three months and at six months. We hypothesize that: (1) individuals in the immediate intervention group achieve better outcomes than individuals in the wait-list control group; (2) the program leads to significant reductions in fatigue impact and fatigue severity, and improved quality of life; and (3) improvements in the outcomes can be maintained over six months.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of MS
* 18 years of age or older
* functional English literacy (i.e., able to read course materials and carry on telephone conservations in English)
* Fatigue Severity Scale score of 4 or greater
* Residing in the state of Illinois

Exclusion Criteria:

* Short version - Blessed Orientation Memory Concentration Test - outside of normal range
Pronostic Value of Endothelial Dysfunction in Heart Failure

The main objective is to evaluate the pronostic value of endothelial dysfonction in acute heart failure on a combined criteria associating cardiovascular mortality, nex hospitalisation for decompensated heart failure, cardiac graft or ventricular assistance 2 month and 1 year before acute heart failure.


Eligibility Criteria:
Inclusion Criteria:

* patients hospitalized for acute heart fialure with Left Ventricular Ejection Fraction (LVEF) \< 45 % on echocardiography

Exclusion Criteria:

* Informed consent form not signed
* Cardiogenic, septic or hemorragic shock
* Acute coronary syndrom with elevated troponin
* valvular surgery or aorto-coronary graft during next 3 months
* Cancer
* Pregnancy
* life expectancy over than 1 year
* chronic renal impairment
Laparoscopic Cholodochotomy in Management of CBD Stones

The aim of this study is to compare the outcomes of primary closure of cholodochotomy incision versus T-tube drainage in laparoscopic common bile duct exploration for management of CBD stones and provide evidence-based guidance to the selection of the most appropriate operative technique.


Eligibility Criteria:
Inclusion Criteria:

1. patients with a definitive preoperative diagnosed with CBD stones.
2. a CBD diameter of ≥1 cm.
3. patients are fit for surgery

Exclusion Criteria:

1. patients with liver cirrhosis.
2. a CBD diameter of \<1 cm
3. malignancy in the biliary tract or CBD stricture .
4. patients are not fit for surgery.
A Clinical Trial Comparing Efficacy And Safety Of Sunitinib Versus Placebo For TheTreatment Of Patients At High Risk Of Recurrent Renal Cell Cancer

To compare the disease free survival time and safety of sunitinib with placebo in adjuvant treatment patients at high risk of recurrent kidney cancer after surgery.


Eligibility Criteria:
Inclusion Criteria:

* High risk renal cancer per modified UISS criteria
* Eastern Cooperative Oncology Group (ECOG) 0-2
* predominant clear cell histology
* No prior anti-cancer treatment
* Kidney tumor has been removed
* No evidence of macroscopic disease following surgery

Exclusion Criteria:

* Histologically undifferentiated carcinomas or collecting duct carcinoma, lymphoma, sarcoma or subjects with metastatic renal sites.
* Diagnosis of any second malignancy within the last 5 years, except basal cell carcinoma, squamous cell skin cancer, or in situ carcinoma of the cervix uteri that has been adequately treated with no evidence of recurrent disease for 12 months
* known HIV or Hepatitis
* any severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or study drug administration
Bioequivalence of Rebamipide in Korean

The aims of this study were to evaluate the pharmacokinetic properties and bioequivalence of two rebamipide preparations in healthy Korean male volunteers for generic substitution and to evaluate the association between the genetic polymorphisms in ABCB1 gene (exon 21 and 26) and rebamipide disposition.

A randomized, single-dose, 2-period crossover design with a 7-day washout period was conducted in 30 healthy Korean male volunteers. Subjects were randomly assigned to receive a single 100-mg dose of the test or reference preparation of rebamipide, administered with 240 mL of water after a 12-hour overnight fast. All subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests. Serum concentrations of rebamipide up to 12 hours after administration were determined using a validated HPLC method with fluorescence detection. Adverse events (AEs) were continuously monitored by clinical staff via observation, personal interview, and vital signs (temperature, blood pressure, heart rate) during the study period. All adverse events were recorded on the clinical record form per subject up to 1 week after the study. Pharmacokinetic parameters were determined using a noncompartmental method. The preparations were considered bioequivalent if the log-transformed ratios of AUC0-t, AUC0-∞, and Cmax were within the predetermined bioequivalence range (ie, 80-125%), as set by the US Food and Drug Administration (FDA) and Korean legislation. In vitro dissolution profiles of both preparations were examined and the influence of genetic polymorphisms in ABCB1 gene (P-glycoprotein) on the pharmacokinetics of rebamipide was also investigated.

Eligibility Criteria:
Inclusion Criteria:

* Subjects were selected after passing a clinical screening procedure that included a physical examination and laboratory tests (blood analysis; hemoglobin, hematocrit, RBC, WBC, platelet, differential counting of WBC, total proteins, albumin, ALT, AST, alkaline phosphatase, total bilirubin, cholesterol, creatinine, blood urea nitrogen, and fasting glucose and urine analysis; specific gravity, color, pH, sugar, albumin, bilirubin, RBC, WBC and cast).

Exclusion Criteria:

* Subjects possibly sensitive to this type of preparation,
* Subjects who had a history of any hepatic illness,
* Subjects who had a history of any renal illness,
* Subjects who had a history of any respiratory illness,
* Subjects who had a history of any endocrine illness,
* Subjects who had a history of any cardiovascular system illness,
* Subjects who had taken alcohol within 4 weeks prior to the study,
* Subjects who had taken other preparations within 4 weeks prior to the study.
Evaluation of Web-based Interventions to Support People Living With HIV in the Adoption of Health Behaviors

The purpose of this study is to evaluate the efficacy of a web-based tailored intervention to support persons living with HIV (PLHIV) manage the demands inherent to their health condition, particularly as regards to the adoption of health behaviours such as being physically active, following a healthy diet and quitting smoking.

This randomized controlled trial is currently conducted entirely online at www.lhivehealthy.ca

This online randomized controlled trial with parallel-groups is conducted across Canada. Interested participants are invited to visit the study's Website at www.lhivehealthy.ca

The study's Website contains video clips explaining the study. After accepting the conditions and consenting, participants will enroll in the study by providing an email address and a pseudonym. Each participant will be validated through an email address check. After their enrolment, participants will receive a hyperlink via email to invite them to complete a baseline questionnaire.

After completing the baseline questionnaire, participants will be randomly assigned by the computer system either to an experimental group (TAVIE en santé) or to a control group (list of 5 websites).

Three and six months after the baseline questionnaire, participants will complete the online questionnaires again.

Eligibility Criteria:
Inclusion Criteria:

* to be living with HIV
* to be able to read and understand French or English
* to have access to the Internet
Comprehensive DNA Methylation Profiling in Crohn's Disease

Previous studies have indicated that abnormal DNA methylation frequently occurs in the mucosa in Crohn's disease. Comprehensive DNA methylation profiling of the inflamed and non-inflamed ileal mucosa of patients with Crohn's disease was performed. Genome-wide DNA methylation was determined using the Illumina HumanMethylation 850k BeadChip.


Eligibility Criteria:
Inclusion Criteria:

* Active Crohn's disease(CDAI score≥ 150)

Exclusion Criteria:

* No ileal lesions
* Under treatment of immunomodulators, biologic agents or steroids
Role of Probiotics as Adjunct Therapy Along With Standard Care in Decreasing Hospital Stay and Improving Symptoms in Pediatric Patients Admitted With Severe Pneumonia

Probiotics as adjuvant therapy along with standard care can decrease hospital stay and improve symptoms (fever, tachypnea,cough) in pediatric patients admitted with severe pneumonia.

After getting written informed consent from parents/attendants, all patients aged 6 month-2yrs admitted with severe pneumonia in pediatric wards of children hospital, during the study time of 6 month will be recruited.After applying exclusion criteria remaining participants will be included in the study. The study population will be randomized in to two groups, Group A will be given probiotic sachet and group B will be given simple milk as placebo.The patients and their parents/attendants will be kept blind to the fact that they are receiving either probiotic or placebo The probiotic and placebo mixture will be given daily for three days.The patients in both the groups will be followed for the duration of illness until they are either discharged or show any adverse outcomes of pneumonia.Total days of admission will be recoded for patients discharged from hospital.Parents will be asked questions regarding improvement in symptoms like fever on discharge. Duration for Improvement in tachypnea andcough will be noted for all patients. Outcomes will be duration of hospital admission, improvement in fever, tachypnea and cough.All the data collected will be entered and analyzed using SPSS latest version and analysed.

Eligibility Criteria:
Inclusion criteria Patient aged 2month-24months. Both male and female children

Exclusion Criteria:

Patients with severe acute malnutrition Patients with very severe pneumonia Patients with Other concurrent infections Patients having any chronic debilitating condition Children who took probiotics in past 6 months Patient requiring mechanical ventilation