cyrilzakka/clinical-trials huggingface dataset:
The Effects of a Mediterranean Diet in Pediatric Hyperlipidemia

Children with high cholesterol levels are especially vulnerable and are at high risk for early onset coronary heart disease (CHD). Endothelial dysfunction, the earliest phase of CHD, is present in children with elevated cholesterol levels as early as 8 years of age. The long term objective of this study is to develop dietary interventions for the prevention and treatment of endothelial dysfunction in children with common lipid disorders including familial hypercholesterolemia (FH) and familial combined hyperlipidemia (FCH). Increasing evidence suggests that the Mediterranean diet and ω-3 fatty acids found in fish have cardioprotective effects. The specific aims of the study are to: determine whether a Mediterranean diet alone or combined with ω-3 fatty acid (eicosapentaenoic acid)improves endothelial function; evaluate the effects of the dietary interventions on lipids and lipoprotein subclasses; evaluate the effects of the dietary interventions on biomarkers for oxidative stress and inflammation. This study is a randomized, double-blind, placebo-controlled clinical trial that includes 34 children (ages 8-17) treated with the Mediterranean diet and ω-3 fatty acid supplements. A dietary educational behavioral intervention will be conducted over 6 months with individual counseling and group sessions. Endothelial function will be measured noninvasively by high resolution ultrasound of the brachial artery at baseline, 6, 12, 18 and 24 weeks. This study is unique because it is a new intervention designed for children at high risk for early CHD with a dietary component and supplementation with ω-3 fatty acids. If effective, this intervention would be broadly applicable in the community and lend valuable insight about dietary therapy to prevent the progression of CHD in hyperlipidemic children.


Eligibility Criteria:
Inclusion Criteria:

* Children (8-17 years old)
* Familial Hypercholesterolemia or Familial Combined Hyperlipidemia
* Able to read, write and understand English
* Parental consent and child assent
* Access to a computer and internet and literacy in the use of the internet
* The attendance of a parent to each educational session.

Exclusion Criteria:

* Chronic systemic illness with or without secondary hyperlipidemia
* Current smoking
Evaluation Of SB-751689 Administered At Supratherapeutic Dose Levels In Healthy Adult Subjects.

This study will evaluate the safety, tolerability and exposure of SB-751689 when administered alone at supratherapeutic doses and when SB-751689 is co administered with ketoconazole, a PGP/CYP3A4 inhibitor that increases exposure of SB-751689. Data from this study will enable the planning and conduct of a QTc study for SB-751689.


Eligibility Criteria:
Inclusion Criteria:

* Healthy adults aged 18-60yrs, with BMI of 19-31kg/m2.
* Females must be of non-childbearing potential.
* Subjects must be able to give consent and comply with restrictions of study.

Exclusion Criteria:

* Clinically relevant abnormality from history, physical, 12-lead ECG, Holter monitoring, or clinical laboratory examination.
* Positive urine drug screen.
* Positive urine test for alcohol.
* Contine levels indicative of smoking.
* Positive HIV or Hep B and/or C assay.
* History or smoking in last year or \>10 pack/year history of smoking overall.
* History of regular alcohol consumption (7 units/week for women and 14 units/week for men) within 6 months of study.
* History of drug abuse within 6 months of study.
* Participation in another drug trial within 30 days of first dose.
* Exposure to more than 4 new chemical entities within 12 months of first dose.
* Use of prescription and non-prescription drugs including dietary supplements, herbals and St. John's wort within 14 days of first dose.
* Consumption of red wine, grapefruit, grapefruit juice and grapefruit products within 14 days of first dose.
* Donation of blood in excess of 500 mL within 56 days of dosing.
* Evidence of renal, hepatic or biliary impairment.
* History of serious gastrointestinal disease or history of gastrointestinal surgical procedure that might affect absorption of study drug.
* History of sensitivity to any of the study medications.
* History of clinically significant cardiovascular disease.
* History of pernicious anemia, pancreatitis, osteosarcoma or kidney stones. Medical conditions which might alter bone metabolism.
* Liver function tests above ULN at screening and PTH, glucose, and CPK outside the reference range at screening.
* Males unwilling to refrain from fathering a child during the study and for 14 days following the last dose of study medication.
Safety/Efficacy Study of Restylane® in Lip Augmentation

To determine the safety and effectiveness of Restylane® when used for lip augmentation.


Eligibility Criteria:
Inclusion Criteria:

* Must meet established lip fullness criteria

Exclusion Criteria:

* Allergic to injectable hyaluronic acid, local topical anesthetics or nerve blocking agents; Conditions/procedures that could interfere with lip fullness evaluations
Effect of Different Fiber Breakfasts on Appetite and Weight Change in Overweight Subjects

Regular breakfast consumption may help lower body weight reduce body fatness and improve cardiovascular disease risk factors. However, the best kind of breakfast to consume to achieve these effects is unclear. We hypothesized that a high fiber breakfast would suppress appetite, lower body weight and improve cardiovascular disease risk factors compared with a no-fiber breakfast.

Participants will report to the hospital cafeteria between 0800 and 0900h following an overnight fast every weekday for 4 consecutive weeks. On arrival, participants will be provided will the allocated breakfast and will be given 15 min to consume all the foods provided. The oatmeal breakfast will consist of 80g dry oatmeal (Quaker Quick Oats) prepared with 120mL fat-free milk and 230mL water. The frosted flakes breakfast will consist of 62g frosted flakes and 160mL whole milk and 190mL water served on the side. The No-breakfast (control) will consist of only 350mL plain water. All participants will also receive 200mL decaffeinated coffee with 12mL non-dairy creamer and 1g packet of non-caloric sweetener. On Friday of each week participants will be provided with two portions of the breakfasts to take home at consume on the weekend days. On the first day of the intervention and weekly thereafter participants will complete 3hr subjective appetite ratings responses to the breakfast. Laboratory assessments including body weight, composition, blood pressure and a fasting blood sample will be collected before the start of the intervention and at the end of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* BMI \>27kg/m2
* Weight stable (\<5% weight change in past 3 months)

Exclusion Criteria:

* Smokers
* Regular use of medications
* Currently undertaking a weight-loss or exercise program
* Females who are pregnant or lactating
Effects of Neuromuscular Electrical Stimulation on Muscle Mass and Strength in Critically Ill Patients After Cardiothoracic Surgery

The purposes of this study are 1) to determine whether neuromuscular electrical stimulation (NMES) is effective in preventing loss of muscle mass and strength and 2) to observe the time variation of MLT and strength from preoperative day to hospital discharge.

In the amendment of June 2011, a twofold study setting was defined in order to recruit patients not only before, but also after cardiothoracic surgery. In sample A, patients were recruited before surgery. In sample B, patients were recruited after surgery. On postoperative day 1, randomization was performed for sample A and B separately. To ensure balance of the NMES and control groups with respect to disease severity, randomization was stratified by the SAPS II score on the first postoperative day. In the intervention group, the anterior muscles of both thighs were electrically stimulated from the first postoperative day until ICU discharge for a maximum of 14 days. In the control group, the electrodes were applied, but no electricity was delivered.The primary outcomes muscle layer thickness (MLT) and muscle strength were assessed from the first postoperative day to ICU discharge and at hospital discharge. All patients in sample A had an additional assessment of MLT and strength before surgery.

All data are analyzed according to the intention-to-treat principle with no imputation for any missing data. Linear mixed models are used to account for the repeated measurements per patient and to determine any fixed effects on MLT and MRC score.

Eligibility Criteria:
Inclusion Criteria:

* patients before/after cardiothoracic surgery
* ICU stay \> 48 hours

Exclusion Criteria:

* body mass index \> 40 kg/m2
* severe leg swelling
* implanted ventricular assist device (RVAD, LVAD, BiVAD)
* implanted intra-aortic balloon pump (IABP)
* neuromuscular diseases
* skin lesions in stimulation area
* leg excluded if implant (hip or knee replacement) in stimulation area
Evaluation of the Role of Adalimumab on Extraarticular Manifestation - Bone Metabolism and Bone Mineral Density in Patients With Active Rheumatoid Arthritis

This post marketing observational study will be conducted in a prospective, single country, multicenter format to assess the prevention of generalized bone loss in patients with active rheumatoid arthritis (RA) treated with adalimumab (Humira®) in pragmatic prescribing situations. The investigational sites will be centers with experience in the treatment of RA patients and anti-tumor necrosis factor-alpha (TNF-a) therapy. The investigators will be rheumatologists authorized by the Czech Rheumatologic Society for prescribing biological treatment.


Eligibility Criteria:
Inclusion Criteria:

* Patients with active early and long-standing RA according to American College of Rheumatology (ACR) 1987 revised criteria.
* Patients with high disease activity DAS28 ≥ 5.1 according to the Czech Rheumatological Society criteria.
* Patients must fulfill national guidelines for use of anti-TNF: inadequate clinical response to at least one disease-modifying antirheumatic drug (DMARD; methotrexate, sulphasalazine, leflunomide, hydroxychloroquine, or combinations) and oral glucocorticoids (equivalent to ≥ 5 mg prednisolone per day), (for Romania except glucocorticoids); chest X-ray, purified protein derivative (PPD)-skin test, Quantiferon/tuberculosis (TB) Gold test (if available) negative for TB.

Exclusion Criteria:

* Patients who have had a history of TNF blocking or rituximab therapy.
* Patients who are being treated or will be treated with drug at risk of interaction with adalimumab (Humira).
* Pregnant females and/or females without adequate method of contraception.
* Patients who didn't receive prior DMARD therapy.
* Patients participating in another study or clinical trial.
* Patients with severe osteoporosis (T-score \[number that indicates whether or not bone loss has occurred\] of ≤ -2.5 and/or prior vertebral fracture/s).
* Patients with a history of total hip replacement of both extremities.
* Patients who currently receive and/or received bone metabolism modulating agents including Selective Estrogen Receptor Modulators (SERMs), bisphosphonates, parathyroid hormone or anti-receptor activator of nuclear factor-kappaB ligand (RANKL) therapy.
* Subjects who are not eligible for TNF-blocking therapy according to the Czech National Registry (ATTRA).
Effects of Hernia Repair on Men's Sexual Functions

In the literature, there are several studies that compare Laparoscopic totally extraperitoneal hernia repair (TEP) with Lichtenstein hernia (LH) repair. There are no studies that compare sexual functions on men's health and quality of life. Our aim was to study the sexual functions of men, who underwent TEP or LH repair according to Health Survey Scoring Demonstration (SF36) and The International Index of Erectile Function (IIEF).

176 men with unilateral inguinal hernia were randomized into two groups. Group T (n=88) underwent TEP and Group L(n:88) underwent LH repair. Patients demografigs, perioperative findings were recorded. For all patients preoperative, postoperative 7th,30th and 90th day SF 36 and IIEF were filled up.

Eligibility Criteria:
Inclusion Criteria:

* having male gender
* patients diagnosed on unilateral inguinal hernia
* patients aged between 18 and 65 years
* ASA I and II patients

Exclusion Criteria:

* having female gender
* patients diagnosed on bilateral or recurrence inguinal hernia,
* patients suffering erectile dysfunction
Patient-Reported Outcome Version of the Common Criteria for Adverse Events

Childhood cancer survivors are vulnerable to treatment-related late effects, including physical and psychosocial morbidities, subsequent malignancies, and premature death. Symptom assessment provides a unique insight into survivorship care since symptoms not only indicate the manifestation for the occurrence of chronic health conditions, but also impact quality of life and survival. The National Cancer Institute (NCI) has developed a Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) to assess symptomatic adverse events (AEs) for adult-onset cancer patients who are receiving cancer therapies. However, content-appropriate and clinically validated symptom assessment tools for adult survivors of childhood cancer are not available.

Primary Object 1: Establish content validity for the PRO-CTCAE-SCC

Primary Objective 1A: Conduct a symptom selection process through qualitative research to identify symptomatic AEs for adult survivors of childhood cancer

Primary Objective 1B: Create symptomatic AE items for adult survivors of childhood cancer based on the prevalence and clinical importance ratings on the items

Primary Objective 2: Validate the PRO-CTCAE-SCC using psychometric methods and objective clinical parameters

Primary Objective 2A: Test dimensionality for the PRO-CTCAE-SCC

Primary Objective 2B: Test clinical validity for the PRO-CTCAE-SCC

Primary Objective 2C: Test responsiveness to change for the PRO-CTCAE-SCC

Secondary Objective 1: Increase clinical usefulness of the PRO-CTCAE-SCC

Secondary Objective 2: Establish meaningful cut-points and minimally important differences (MIDs) on symptom burden scores for clinical decision-making

We propose to adapt an existing symptomatic adverse event tool, the Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE), to be content appropriate and clinically meaningful for adult survivors of childhood cancer using two well-established childhood cancer survivor cohorts. Psychometric methodologies will be used to validate this tool by incorporating objective clinical anchors collected from medical evaluations. Our symptomatic AE tool has the potential to augment the Children Oncology Group Survivorship Care Guidelines by implementing risk-based symptom screening to track and anticipate adverse health events.

Eligibility Criteria:
Inclusion Criteria:

* \> or equal to16 years of age at the time of enrollment
* \> or equal to 5 years from initial diagnosis of pediatric cancer/malignancy (for CCSS and SJLIFE survivors only) and currently not receiving cancer therapies.

Exclusion Criteria:

* Have a known severe neurocognitive impairment, which requires proxies/parents to complete the survey
* Have \< third grade reading level or are not able to communicate in English
* Unable to use and/or access internet or computer/tablet (for survey only)
* Unable to communicate and read in English
Temozolomide in Treating Patients With Brain Metastases

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die.

PURPOSE: Phase II trial to study the effectiveness of temozolomide in treating patients who have brain metastases.

OBJECTIVES:

* Determine the activity of temozolomide in patients with brain metastases.
* Determine the toxicity of this treatment in these patients.

OUTLINE: Patients are stratified according to type of primary cancer (lung carcinoma vs breast carcinoma vs malignant melanoma vs renal cell carcinoma vs colorectal carcinoma vs other).

Patients receive oral temozolomide daily on days 1-7 and 15-21. Treatment repeats every 28 days for up to 12 courses in the absence of disease progression or unacceptable toxicity.

PROJECTED ACCRUAL: A total of 180 patients (30 per stratum) will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Metastatic lesions to the brain

  * Must not require immediate radiotherapy
  * If received prior radiotherapy, must have progressive disease
* Evaluable disease by CT scan or MRI
* Neurologically stable

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* Karnofsky 70-100%

Life expectancy:

* More than 12 weeks

Hematopoietic:

* Absolute neutrophil count at least 1,500/mm\^3
* Platelet count at least 100,000/mm\^3
* Hemoglobin at least 10 g/dL

Hepatic:

* Bilirubin less than 1.5 times upper limit of normal (ULN)
* SGOT or SGPT less than 2.5 times ULN
* Alkaline phosphatase less than 2 times ULN

Renal:

* Blood urea nitrogen less than 1.5 times ULN
* Creatinine less than 1.5 times ULN

Other:

* Not pregnant or nursing
* Negative pregnancy test
* Fertile patients must use effective contraception
* No other concurrent nonmalignant systemic disease
* No acute infection requiring treatment with IV antibiotics
* HIV negative
* No frequent vomiting or medical condition that would preclude oral medication administration (e.g., partial bowel obstruction, inability to swallow)

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* No concurrent hematopoietic growth factors, including epoetin alfa
* No other concurrent biologic therapy

Chemotherapy:

* At least 4 weeks since prior chemotherapy, unless evidence of disease progression
* No other concurrent chemotherapy

Endocrine therapy:

* Concurrent corticosteroids allowed if nonincreasing dose for at least 1 week prior to study

Radiotherapy:

* See Disease Characteristics
* At least 4 weeks since prior radiotherapy to the brain, unless evidence of disease progression
* No concurrent radiotherapy

Surgery:

* At least 3 weeks since prior surgery, unless evidence of disease progression, and recovered

Other:

* No other concurrent investigational drugs
Expanded Access Protocol to Provide Brincidofovir for the Treatment of Serious Adenovirus Infection or Disease

Provide patients with serious AdV infection or disease access to treatment with BCV.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed serious AdV infection based on clinical symptoms and laboratory testing showing AdV in the blood or other bodily fluids
* Able to swallow medication, either tablet or liquid

Exclusion Criteria:

* Previous dosing with Brincidofovir
* If female, not pregnant or trying to become pregnant
Comparing Effect of Hyaluronic Acid and Lipid Coated Carbomer Gel on Dry Eyes After Phacoemulsification in DP

In this study we compare the curative effect of two lubricants Hylorunic acid and visol gel on dry eyes after phacoemulsification in diabetic patients. We check the tear film before operation and check post operate after 2nd week and 4th week of surgery. Its a hospital based study .


Eligibility Criteria:
Inclusion Criteria:

* Patients who have acute dry eye condition before phacoemulsification cataract surgery.

Exclusion Criteria:

* Patients who have chronic dry eye condition before phacoemulsification cataract surgery.
CLARA: Somatic and Germline Mechanisms That Impact Renal Cancer Immunotherapy

The study is studying the joint contribution and interactions of germline variants and somatic mutations and their impact on Renal Cell Carcinoma (RCC) development and treatment (immunotherapy).

One hundred newly diagnosticated stage IV RCC patients will be recruited in the Ribeirao Preto Medical School.

Patients will be treated with immune checkpoint inhibitors (ICI) combination: nivolumab (3 mg/kg of body weight) plus ipilimumab (1 mg/kg) intravenously every three weeks for four doses, followed by nivolumab 480mg every four weeks, until progression, toxicity or complete two years of treatment.

Patients will be followed up for the clinical outcome (progression-free survival, best response, and overall survival).

Fresh-frozen primary tumor tissue will be collected for somatic genomic characterization.

Blood DNA will be genotyped for the identification of common germline variation, as well as ancestry determination.

Eligibility Criteria:
Inclusion Criteria:

* Renal cell carcinoma patient: histological confirmed clear cell tumor;
* First-line metastatic treatment;
* Stage IV with at least one measured lesion;
* Fresh-frozen primary tumor tissue available;
* No previous immunotherapy or tyrosine kinase inhibitor treatment;
* All International Metastatic RCC Database Consortium (IMDC) Risk Score;
* Karnofsky Performance Scale (KPS) \>=70;
* \>=18 years old.

Exclusion Criteria:

* History of a known or suspected autoimmune disease;
* Any condition requiring systemic treatment with corticosteroids;
* Creatinine clearance \< 40mL/min;
* Alanine aminotransferase (ALT) and/or Aspartate Aminotransferase (AST) \> 5 x ULN;
* Pregnant women.
Effectivness of Conservative Techniques in Management of PAS

To evaluate the effectiveness of conservative techniques for placenta accreta spectrum to reduce maternal mortality and morbidity

Placenta accreta spectrum (PAS) represents the spectrum of clinical conditions when part or whole of the placenta becomes abnormally adherent or invades the myometrium . Over the last 40 years, caesarean delivery rates around the world have risen from less than 10% to over 30%, and almost simultaneously a 10-fold increase in the incidence of PAS . PAS is one of the most dangerous conditions of the pregnancy as it is significantly associated with maternal morbidity and mortality .

Ultrasound imaging is the most commonly used technique to diagnose PAS disorders prenatally. There is also wide variation globally on the management of PAS disorders, with some centres opting for a radical approach, whereas others have proposed a range of conservative approaches .

The conservative approaches include one-step conservative surgery, leaving the placenta in situ, the Triple-P procedure, and transverse B-Lynch suture . Recently, Women's health hospital has adopted a new approach for conservative management of most cases of PAS, including wedge resection of the myometrium over the adherent part of the placenta, or a staged-approach following delivery of the fetus starting with meticulous dissection of the urinary bladder form the lower uterine segment, then bilateral uterine artery ligation at a level below the apparent placenta-myometrial bulge, followed by removal of the placenta, after which a catheter is inserted in the cervix and the placental pouch is closed .

Eligibility Criteria:
Inclusion Criteria:

1. - Gestational age starting from 28 weeks onwards.
2. - Women with at least 1 previous hysterotomy (e.g. Caesarean deliveries, myomectomy)
3. - Elective or emergent Caesarean deliveries

Exclusion Criteria:

* A pre-existing decision of performing intrapartum hysterectomy