cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Effects of Orange Consumption on Carbohydrate and Lipid Metabolism in Subjects With MAFLD (Metabolic Associated Fatty Liver Disease)

Given the current increase in the incidence of dyslipidemia and obesity in the general population, there is a strong interest in identifying dietary factors capable of preventing the onset of metabolic diseases or at least capable of reducing metabolic risk. Several experimental evidences have shown that improving the carbohydrate and lipid profile in subjects at risk can reduce mortality linked to cardiovascular, neurodegenerative diseases and cancer. The diet is, therefore, an effective prevention tool in combating diseases related to metabolism, such as MAFLD (Metabolic Associated Fatty Liver Disease). In particular, fruit with its high content of polyphenols has been shown to exert a high anti-inflammatory, antithrombotic and antiproliferative action.

Polyphenols extracted from oranges of the "Tacle" variety have demonstrated in vitro an inhibitory action of cholesterol synthesis. In addition, the consumption of orange juice has been shown to improve the serum lipid profile of obese subjects, as well as "hesperedine", a flavonoid mainly present in oranges is able to reduce the proliferative activity of MCF-7 (human breast cancer cell line with estrogen, progesterone and glucocorticoid receptors) cells.


Eligibility Criteria:
Inclusion Criteria:

* age \> 30 years and \<65 years
* diagnosis of MAFLD on the basis of clinical and instrumental parameters

Exclusion Criteria:

* gastroesophageal reflux diseases;
* inflammatory bowel diseases; oncological diseases;
* serious medical conditions that may impair participation in the trial;
* people who follow a special diet or who use anticoagulants;
* subjects unable to follow a diet for religious or other reasons.
Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue: A Randomized Placebo Controlled Study

To Test Effect of Soy Supplementation on Cellular Markers in Normal and Cancerous Breast Tissue using a Randomized Placebo Controlled Study.

Objectives:

* To determine (by immunohistochemistry) whether specific cellular markers and gene products associated with breast carcinoma can be altered by soy therapy.
* To identify genes that can be altered by soy therapy in normal and neoplastic breast tissues by unbiased gene expression analysis using microarrays.
* To compare specific cellular markers and pathways (immunohistochemistry), and gene expression using microarrays in normal and cancerous breast tissue.

Patient Population:

Pre and post menopausal women with breast cancer diagnosed by core needle biopsy scheduled to undergo breast cancer resection for an invasive carcinoma.

Objectives:

* To determine (by immunohistochemistry) whether specific cellular markers and gene products associated with breast carcinoma can be altered by soy therapy.
* To identify genes that can be altered by soy therapy in normal and neoplastic breast tissues by unbiased gene expression analysis using microarrays.
* To compare specific cellular markers and pathways (immunohistochemistry), and gene expression using microarrays in normal and cancerous breast tissue.

Study Design and Intervention Plan:

* Eligible patients will be consented at the time of visit with MSKCC breast surgeon and randomized to receive soy (soy protein supplementation 50 grams/day), or placebo (milk protein supplementation 50 grams/day) over the period until their surgery.
* The diagnostic biopsy (already available at time of appointment with MSKCC surgeon) will be analyzed by immunohistochemistry for proliferation (Ki67) and apoptosis (TUNEL). Additional immunohistochemistry will include HER2, TP53, cyclin D1, p27, BCL2, ER and PR.
* Excision of the breast carcinoma (lumpectomy or mastectomy) will proceed in standard fashion.
* The post-therapy excision specimen will be processed in a standard fashion. Pathologic features, margin status, and tumor size will be assessed by a light microscopic examination of histological sections. In addition to this routine processing, immunohistochemistry assays for proliferation (Ki67), apoptosis (TUNEL), HER2, TP53, cyclin D1, p27, BCL2, ER, and PR will be performed. For correlative biological studies pathologists will select approximately .5 cubic mm representative sections of the neoplastic tissues and normal adjacent breast tissue, which will be snap frozen for gene expression analysis using microarrays.

Eligibility Criteria:
Inclusion Criteria:

* Informed consent obtained
* Breast mass \> .5 cm (determined by mammogram, ultrasound, MRI, or palpable criteria)
* Core biopsy diagnosis of invasive carcinoma of the breast

Exclusion Criteria:

* History of active malignancy within previous two years (except for non-melanoma skin cancer and history of breast cancer).
* Regular soy consumption (consumption of more than 3 serving of soy or soy products/supplements per week)
* Allergy to soy or milk protein
Role of Ultrasound Assessment of Parasternal Intercostal Muscle Thickness During Weaning From Mechanical Ventilation

Assessment of the the parasternal intercostal muscles thickness by the ultrasonography as a weaning predictor of the mechanically ventilated patients

impact of parasternal muscle thickness on the weaning process of the mechanically ventilated patients in ICU

Eligibility Criteria:
Inclusion Criteria:

Any patient invasively mechanically ventilated at least 24 hours on a pressure support mode who is clinically stable and ready to undergo a spontaneous breathing trial.

All patients will be:

* Alert.
* Afebrile.
* Adequate cough with absence of excessive tracheobronchial secretion.
* Fraction of inspired oxygen (FIO2) of \<50%.
* PEEP ≤8 cmH2O.
* PaO2/FiO2 \> 150.
* pH ≥7.35 and ≤7.45.
* Respiratory rate (RR) ≤35 breaths/min.
* Hemodynamically stable in the absence of vasopressors.
* Stable metabolic and endocrinal status.
* Euglycemic state.
* Adequate mentation (no sedation or stable neurologic patient).

Exclusion Criteria:

Diaphragmatic paralysis (detected by ultrasonography).Patients\&Methods. 6

* Pregnant women.
* Age: \>= 18 years.
* Surgical dressings over measurement point which would preclude ultrasound exam.
* Underweight patients (Body mass index \<18.5 kg/m2).
* Morbidly obese patient (Body mass index ≥ 40 kg/m2).
* Primary neuro-muscular diseases.
* Central coditions with depressed central respiratory drive (encephalitis, and brainstem haemorrhage/ischaemia).
* Repiratory conditions with reduced pulmonary compliance (interstitial lung disease, pulmonary hemorrhage, and diffuse pulmonary infiltrates) or reduced chest wall compliance (kyphoscoliosis).
* Cardiac conditions with high risk of weaning induced pulmonary edema (congestive heart failure, cyanotic heart diease, pulmonary hypertension, and ischemic heart diease).
* Addict patients.
* Patients with psychiatric disease.
Efficacy and Safety of a Combination of Mycophenolate Mofetil and Corticosteroid in Advanced IgA Nephropathy

The purpose of this clinical study is to evaluate the efficacy and safety of that test group was administered with Mycophenolate Mofetil in combination with corticosteroid in patients with advanced IgA nephropathy. The control group will be observed for up to 48 weeks without administration of Mycophenolate Mofetil.

The subject who signed the written agreement to participate in the clinical trial evaluates the conformity and then 1: 1 randomly allocated.

The study group were taken 48 weeks with MYREPT ® capsules in combination with corticosteroids and the control group were asked to preserve the conservative treatment regimen prior to the clinical trial registration Maintenance.

The subject who started taking the study medicine will carry out the examination and procedure if it has to be carried out for the visit via outpatient clinic at 4 weeks, 12 weeks, 24 weeks, 36 weeks, 48 weeks.

Eligibility Criteria:
Inclusion Criteria

1. Patient aged 19 to 65 years old
2. Diagnosed with IgA nephropathy
3. Confirmed with Proteinuria more than 1.0 g / day at least twice within 6 months from the time of screening
4. If eGFR (by MDRD) is \<50 mL / min / 1.73 m\^2, ≥ 15 mL / min / 1.73 m\^2
5. ACE inhibitor or ARB for at least 3 months
6. Willing and able to provide written informed consent.

Exclusion Criteria:

1. If eGFR (by MDRD) is \<15 mL / min / 1.73 m\^2
2. Blood pressure is SBP\> 160 mmHg or DBP\> 100 mmHg
3. Systemic infection or have been diagnosed with cancer within the last 5 years (excluding treatment squamous cell or basal cell carcinoma skin cancer)
4. serious digestive disorder
5. WBC \<3000 / mm\^3
6. Acute (within 4 weeks) or chronic(need to treatments) allergic/hypersensitivity reaction in the history of Investigational drugs
7. Administration of other Investigational drugs within 28days before screening period
8. Administration of Investigator drug or other immunosuppressants within 84days before screening period
9. Women in pregnant or breast-feeding or don't using adequate contraception.
10. Patient has conversation impairment because alcohol or drugs addiction history within 6months or mental illness, etc.
11. In investigator's judgment
Relationship of Nutritional Support for Critically Ill Children with Clinical Outcomes in a Pediatric Hospital in Bolivia (NutPeBol)

The aim of this observational study is to learn about the characteristics of nutritional support in critically ill children. The primary question to be answered is Is there an association between nutritional support of the critically ill child and clinical and hospital outcomes in children admitted to a pediatric referral center? Patients will be followed throughout their hospitalization, with a step-by-step evaluation of the nutritional support received through standard care and a review of the results obtained in the patients.

The study aims to know the type and characteristics of nutritional support received by critically ill children hospitalized in Bolivian hospitals; to follow them during their hospitalization to verify their weight, nutritional status and the nutritional support they receive; to understand which types of nutritional support offer better clinical and hospital outcomes; finally, to be able to propose some guidelines to physicians, through guidelines or other tools for the dissemination of scientific information, in order to benefit more children.

Eligibility Criteria:
Inclusion Criteria:

* Admitted to intensive care or intermediate care in hospital wards
* Complete clinical and anthropometric data.

Exclusion Criteria:

* Congenital or acquired chronic disease affecting growth (secondary malnutrition)
* On medication (corticosteroids, immunoglobulins, albumin)
* Burn patients, with prosthetic implants, postoperative of large tumor resections.
* Unknown history of pre-referral hospital management or hospitalized in other health facilities.
Early Surgical Outcomes in the Use of Hybrid Mesh for Incisional Hernia Repair: Results From a Multicenter Italian Study

Background: Ventral hernia repair poses challenges for surgeons due to controversies in approach, patient selection, and mesh selection. The GORE® SYNECOR Intraperitoneal (IP) Biomaterial, a hybrid mesh, aims to balance durability and infection risk.

Objective: To analyze extended-term outcomes of using the Intaperitoneal device for ventral and incisional hernia repair.

Methods: Retrospective analysis of patients undergoing surgery in eight Italian Surgery Centers, evaluating pIPOM and sIPOM techniques with GORE® SYNECOR IP Biomaterial. Preoperative evaluations included anthropometric measurements, comorbidities, CT scans, and GIQLI assessments. Surgical procedures and interventions were recorded. Postoperative complications, GIQLI changes, cosmesis, hernia recurrence, and mesh bulging were assessed.

The management of ventral hernias, whether they are primary or incisional, presents a significant challenge for abdominal wall surgeons. Laparoscopic ventral hernia repair has become a widely accepted technique on a global scale, with literature reporting favorable outcomes, even over the long term. Nevertheless, various substantial controversies have emerged concerning the ideal approach and patient selection and "ideal mesh". Permanent mesh materials with a macro-porous structure have demonstrated excellent durability, a low risk of infection in ventral hernia repair. Nevertheless, hernia recurrences and complications can still occur. The use of absorbable mesh materials may reduce the risk of infectious complications and the need for mesh removal. However, it might be associated with a higher likelihood of long-term recurrence when compared to permanent materials.

In response to these challenges, hybrid mesh materials, combining both absorbable and permanent components, have been developed to strike a balance between achieving long-term durability and minimizing the risk of infection or "Mesh removal". These hybrid meshes can be utilized either intraperitoneally or extra-peritoneally depending on their composition.

One example of such a hybrid mesh is the GORE® SYNECOR Intraperitoneal Biomaterial (referred to as the device), manufactured by W.L. Gore \& Associates, Inc. in Flagstaff, AZ. This composite mesh comprises a bioabsorbable 3D web scaffold and a permanent dense polytetrafluoroethylene (PTFE) monofilament macro-porous knit. The device is specifically designed for intraperitoneal placement, using either an underlay or intraperitoneal onlay technique.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* Clean wounds
* Informed consent
* Patients affected by Incisional and Ventral Hernia
* Elective surgery
* Hernia size between 3 e 10 cm

Exclusion Criteria:

* age \< 18 years;
* Life expectancy \< 24 months (as estimated by the operating surgeon), -
* Pregnancy
* Immunosuppressant therapy within 2 weeks before surgery
* Clean-contaminated and contaminated, dirty wounds
* Cirrhosis
Daily Low-level Red Light and 0.01% Low-dose Atropine for Myopia Prevention

To compare the preventive effects of daily low-level red-light and 0.01% low-dose atropine eye drops on myopia.


Eligibility Criteria:
Inclusion Criteria:

* 1. Aged at least 7 years old. 2. The spherical equivalent error (SER) after pupil dilation was between -0.5 D and +0.75D.

  3. Had a record of cycloplegia SER at least 6 months before this study, and SER changed -0.5D compared with the last measurement or had a family history of high myopia.

  4. Corneal astigmatism ≤ 1.25D. 5. Interocular refraction discrepancy ≤ 1.5D. 6. No allergy history of cycloplegia drugs. 7. Willingness to participate in the study and signed informed consent.

Exclusion Criteria:

- 1. Intraocular pressure was below 10 mm Hg or higher than 22 mm Hg. 2. Presence of amblyopia, or ocular pathological conditions such as retinal, lens, or corneal disorders.

3. Children currently using other myopia interventions other than LDA or LLRL. 4. Children with systemic and immune disorders, such as albinism, psoriasis, nephrotic syndrome, systemic lupus erythematosus, and diabetes 5. Individuals with conditions like Tourette's syndrome or epilepsy.
Evaluation of Azacitidine in Transfusion Dependent Patients With Low-risk Myelodysplastic Syndrome (MDS) or Chronic Myelomonocytic Leukemia (CMML)

Azacitidine has proved prolonged overall survival in patients with high-risk MDS. Minor pilot studies have shown that treatment with Azacitidine can induce transfusion independency in previous transfusion dependent patients with low-risk MDS. This study will evaluate the effect of Azacitidine in transfusion dependent patients with low-risk MDS (IPSS low or int-1) or low risk CMML. Included patients should first have failed, or considered not being eligible to, treatment with EPO +/- G-CSF. Our hypothesis is that Azacitidine can lead to transfusion independency in this group of patients. Those patients who do not respond to treatment with Azacitidine alone, will be given treatment with the combination of Azacitidine and EPO where our hypothesis is that Azacitidine can restore sensitivity to EPO.


Eligibility Criteria:
Inclusion Criteria:

* Must be 18 years of age at the time of signing the informed consent form
* MDS at IPSS Low or Int-1, or mixed MDS/MPD; either CMML with \< 10% marrow blasts or RARS-T
* Patients with high or intermediate probability for response according to the predictive model (see Hellstrom-Lindberg et al, Br J Haematol 99:344-51 1997)should be refractory to EPO / darbepoetin (equivalent to \> 60 000 U of EPO / week for \> 8 weeks) followed by EPO + G-CSF for \> 8 weeks, or biosimilar drugs in equipotent doses, or EPO + G-CSF upfront for 8 weeks. Patients with low probability for response according to the predictive model, could be included without prior EPO/G-CSF treatment
* Transfusion need \>4 units over the last 8 weeks, or \>8 units over the last 26 weeks.
* Subject has signed the informed consent document.
* Men and women of childbearing potential must use effective contraception during, and for up to 3 months after treatment.

Exclusion Criteria:

* Pregnant or lactating females.
* Patients who are eligible for curative treatment
* Expected survival less than 24 weeks.
* Symptomatic thrombocytopenia / active bleeding
* Patients with JAK-2 positive RARS-T if eligible for new investigational drugs
* Serum biochemical values as follows

  1. Serum creatinine \>2.0 mg/dL (177 micromol/L)
  2. Serum aminotransferase (AST)/serum glutamic-oxaloacetic transaminase (SGOT) or alanine transaminase (ALT)/serum glutamate pyruvate transaminase (SGPT) \>3.0 x upper limit of normal (ULN)
  3. Serum total bilirubin \>1.5 mg/dL (26 micromol/L)
* Uncontrolled systemic infection
* Considered not capable of following the study protocol
Efficacy and Safety of Oral Regimens for the Treatment of Chronic HCV Infection

This study will evaluate the antiviral efficacy, safety, and tolerability of combination therapy with oral regimens for the treatment of chronic hepatitis C virus (HCV) infection.


Eligibility Criteria:
Key Inclusion Criteria:

* Willing and able to provide written informed consent
* Chronic HCV infection
* Cirrhosis determination (liver biopsy may be required)
* Screening laboratory values within specified limits
* Males and females of childbearing potential who engage in heterosexual intercourse must agree to use protocol specified method(s) of contraception
* Specific genotype, prior medical history, or concurrent disease as required by the specific study group

Key Exclusion Criteria:

* History of clinically significant illness or any other medical disorder that may interfere with subject treatment, assessment or compliance with the protocol
* Pregnant or nursing female, or male with pregnant female partner
* Clinical hepatic decompensation (ie, ascites, encephalopathy or variceal hemorrhage)
* Use of any prohibited concomitant medications

Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Enhancing the Anabolic Effect of Perioperative Nutrition With Insulin While Maintaining Normoglycemia

The purpose of this study is to find out whether adding insulin after current colorectal cancer surgery promotes making and keeping proteins in the body, and to find out whether or not this effect can be further increased by increasing the amount of protein given.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists class\<3
* age\>18 years
* colorectal surgery for non-metastatic colorectal adenocarcinoma including right and left hemicolectomy, transverse, subtotal and total colectomy sigmoid and low anterior resection
* ability to give informed consent

Exclusion Criteria:

* BMI\>30 Kg/meter squared
* confirmed diagnosis of diabetes mellitus or a HbA1c\>6.0%
* significant cardiorespiratory, hepatic, renal and neurological disease
* musculoskeletal or neuromuscular disease
* ingestion of drugs known to affect protein, glucose and lipid metabolism (e.g. steroids)
* severe anemia (hemoglobin\<10 g/dL
* pregnancy
* history of severe sciatica, back surgery or other conditions which contraindicate the use of epidural catheters
A Cohort Prospective Study of Predictors Influencing the Quality of Visualization of the Operating Field During Orthognathic Surgery

It is very important to decrease the bleeding during bimaxillary osteotomy in order to increase the visibility of the surgical site. Our primary goal is to investigate the predictive value of pre- and perioperative factors, including controlled hypotension, on visibility of surgical site during bimaxillary osteotomy.

100 patients undergoing bimaxillary osteotomy under general anesthesia will be included into this prospective cohort study.

There will be two episodes of controlled hypotension for upper and lower jaw respectively. Hypotension will be induced and sustained according to the same procedure as described here. Controlled hypotension will be induced (intravenous administration of nitroglycerin 2-10 µg/kg/min) 15 minutes prior to the start of mucosal detachment, and will be sustained for the osteotomy stage. The surgeon will evaluate the surgical field quality (in terms of bleeding) according to Modena Bleeding Score (MBS), with scores 1-2 being satisfactory to proceed with the osteotomy. The following arterial pressure correction (proceeding with controlled hypotension or returning to normotension) will depend on the bleeding in the surgical field and the monitoring of cerebral oxygen saturation carried out using near-infrared spectroscopy (NIRS) . The lowest targeted arterial pressure in order to have a clear surgical field will be 55 mmHg. However when the cerebral oxygen saturation decreases by 20% compared with the baseline at any arterial pressure level intervention would be carried out by Norepinephrine (intravenous, individual dosage for each patient - as judged by the anesthesiologist). Arterial blood samples will be taken at 3 time points (at the start of the surgery, during controlled hypotension phase, after extubation) for arterial gas analysis. Two blood samples will be taken to measure (prior to surgery and immediately after surgery) neuron-specific enolase (NSE), cystatin c and troponin I levels. The general condition, operation, anesthesia and hospitalization related data of the patients will be recorded. Cognitive function will be evaluated within 3 days before surgery and 2 days and 1 month after surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients refered for bimaxillary osteotomy under general anesthesia with endotracheal intubation;
* Anesthesia risk classes (ASA) I and II;
* Written statement of informed consent.

Exclusion Criteria:

* Hypertension as a symptom of hypertensive heart disease or endocrine dysfunction;
* Patients receiving antihypertensive drugs;
* Patients receiving anticoagulant therapy;
* Ischemic heart disease;
* Cerebrovascular insufficiency;
* Severe hypovolemia;
* Anemia;
* BMI 30 kg/m2 and higher;
* Connective tissue disorders;
* Pregnancy;
* Participation in other clinical studies;
* Recent history of substance abuse (recreational drugs, alcohol);
* Allergies to drugs used in the study;
* Anxiety requiring psychiatrist supervision and pharmacological therapy.