Kornimate/medical-research-clean huggingface dataset:
effect of high protein diet on hepatic steatosis in patients with mafld

Conditions: Metabolic Dysfunction Associated Fatty Liver Disease

Summary: mafld is a growing problem in india. its pathophysiology is complex, but focused on abnormal substrate handling due to mitochondrial dysfunction reflecting as metabolic inflexibility. nutrition is the cornerstone of management. the ideal macronutrient distribution within a hypocaloric diet is not known yet. evidence from experimental and a few human studies in obese, highlight the role of dietary proteins, independent of calorie restriction, in reducing hepatic steatosis by improving the cellular and systemic bioenergetics.

novelty: first study to assess the effect of high protein diet (hpd) in comparison to a standard protein diet (spd) within a calorie restricted diet, on both the cellular and systemic bioenergetics in patients with mafld. objectives: aims to see the effect of hpd on hepatic steatosis, cellular and systemic bioenergetics, along with metabolic parameters in patients with mafld. method: in this rct, patients with mafld (n=140) with or without ms, would be randomized into hpd or spd groups (i.e. 70 in each group), and parameters like hepatic steatosis (cap by transient elastography (fibroscan), cellular bioenergetics by oxygen consumption rate (ocr) and extracellular acidification rate (ecar) as measured using seahorse analyzer, and indirect calorimetry will be used to assess the fasting and postglucose challenge (oral glucose tolerance test) ree and rq. dexa scan would be used to assess body composition apart from routine blood tests to assess features of metabolic syndrome. the serum levels of glp1, ckk, ghrelin, fgf21, adipokines like leptin and adiponectin, nadh/nad ratio, insulin and glucagon would be measured. outcome: a hpd is expected to improve hepatic steatosis, blunted fuel switching (rq) and cellular bioenergetics (ocr) along with metabolic parameters in patients with mafld.

Eligibility criteria:
inclusion criteria: * newly diagnosed treatment naïve consenting adults with mafld (controlled attenuation parameter; cap \>250, bmi\>23 and/or dm) age 18-65 years exclusion criteria: * • lean (bmi \<23) patients * age \ 65 years * individuals who had been hospitalized with complications of diabetes mellitus, chronic kidney disease, hypertension in the previous 6 months * patients with viral hepatitis * patients with significant alcohol consumption (regular consumption of \> 10g per day for females and \> 20g/d in males), * patients having chronic inflammatory bowel disease or any chronic and autoimmune diseases will be excluded * pregnant \& lactating women

Keywords: mitochondrial dysfunction metabolic inflexibility fgf21 resistance
ex vivo evaluation of the interest of the association of platinum with a molecule bh3-mimetic abt-737 in samples of ovarian tumors

Conditions: Ovarian Cancer

Summary: the aim of the study is to quantify the ex vivo induction of apoptosis by abt-737 + association platinum in samples exposed and demonstrate the value of this combination compared to the agents used alone.


Eligibility criteria:
inclusion criteria: * patient aged over 18 years * ovarian cancer patients with at least five tumor samples does not affect the diagnosis, based on other tumor masses * surgery of any initial chemotherapy naive * patient information and signed informed consent exclusion criteria: * a person deprived of liberty or under guardianship * insufficient tumor samples of ovarian cancer.

Keywords: cancer ovarian chemotherapy bh3-mimetic platin ex-vivo
open-label extension study of gb002 in adult subjects with pulmonary arterial hypertension (pah)

Conditions: Pulmonary Arterial Hypertension

Summary: this open-label extension study will evaluate the long-term effects of gb002 (seralutinib) in subjects who previously participated in a gb002 pah study.


Eligibility criteria:
inclusion criteria: type of subject and disease characteristics 1. subjects must have completed a prior gb002 pah study and, in the opinion of the investigator and sponsor, have been compliant with study procedures and have completed treatment with ip through parent study end-of-treatment (eot) visit. 2. treatment with standard of care pah disease-specific background therapies (stable dose). informed consent 3. review and signature of an irb-approved informed consent form. exclusion criteria: medical conditions 1. persistent and clinically significant systemic hypertension or hypotension. 2. interval history of newly developed left-sided heart disease. 3. potentially life-threatening cardiac arrhythmia with an ongoing risk. 4. uncontrolled bacterial, viral, or fungal infections which require systemic therapy. 5. other severe acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation or gb002 administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the subject inappropriate for entry into this study. 6. history of portopulmonary hypertension or portal hypertension due to cirrhosis classified as child-pugh class a or higher. 7. subjects with a history of severe milk protein allergy. in addition, subjects with known intolerance or hypersensitivity to lactose who, in the opinion of the investigator, may experience severe symptoms following the ingestion of lactose. 8. current use of inhaled tobacco and/or inhaled marijuana. ingestible or topical marijuana is allowed, per local restrictions and regulations. 9. current alcohol use disorder as defined by dsm-5, and/or history of current utilization of drugs of abuse (amphetamines, methamphetamines, cocaine, phencyclidine \[pcp\]). 10. have any other condition or reason that, in the opinion of the investigator and/or the sponsor's medical monitor (or designee), would prohibit the subject from participating in the study. diagnostic assessments 11. chronic renal insufficiency 12. hemoglobin (hgb) concentration \<8.5 g/dl. 13. absolute neutrophil count (anc) \< 1x 10\^9/l. 14. platelet count \<50 x 10\^9/l. prior therapy 15. use of inhaled prostanoids. 16. chronic use of oral anticoagulants (ie, vitamin k antagonist such as warfarin or novel oral anticoagulant \[noac\]/direct oral anticoagulant \[doac\]). 17. chronic use of any prohibited medication. note: additional inclusion/exclusion criteria may apply, per protocol.

Keywords: seralutinib
high-activity natural killer immunotherapy for small metastases of pancreatic cancer

Conditions: Pancreatic Cancer

Summary: the aim of this study is the safety and efficacy of high-activity natural killer immunotherapy to small metastases of pancreatic cancer.

by enrolling patients with small metastases of pancreatic cancer adapted to enrolled criteria, this study will document for the first time the safety and the short and long term efficacy of high-activity natural killer cells. the safety will be evaluated by statistics of adverse reactions. the efficacy will be evaluated according to local relief degree, progress free survival (pfs) and overall survival (os).

Eligibility criteria:
inclusion criteria: * all standard therapies have failed according to nccn guidelines or the patient refuses standard therapies after cancer recurrence * body tumor 1-6, the maximum tumor length \< 2 cm * kps ≥ 70, lifespan \> 6 months * platelet count ≥ 80×109/l，white blood cell count ≥ 3×109/l, neutrophil count ≥ 2×109/l, hemoglobin ≥ 80 g/l exclusion criteria: * patients with cardiac pacemaker * patients with brain metastasis * patients with grade 3 hypertension or diabetic complication, severe cardiac and pulmonary dysfunction

Keywords: metastatic pancreatic cancer high-activity natural killer immunotherapy
the bridge registry: safety and efficacy registry of bx cypher stent

Conditions: Coronary Artery Disease

Summary: the objective of this study is to establish the safety and efficacy of the treatment with cypher des in diabetic patients with documented ischemia due to stenosis (small coronary artery 2.5 -3 mm in lumen diameter, with lesion between 15 mm 30 mm in length, ) in native coronary arteries. the objective of this study is to document that the use of cypher des in these diabetic patients undergoing percutaneous revascularization for stenosis is safe. safety will be assessed over a period of 12 months.

this is a prospective, multicenter, comparative, non randomised, open registry of 1000 patients who will be followed up to 12 months at 100 sites in france. patients will be screened according to normal practice and in relation to the inclusion and exclusion criteria. patients should have a documented ischemia related to the target vessel. procedure of stent placement should be done under existing in hospital procedural protocol and care should be taken to follow cordis instructions as set forth in the instructions for use. follow up will be done according to normal procedure and the minimum should be a telephone contact at 1, 6 and 12 months. all data gathered during the enrollment, procedure, follow up and when specific events to the patient may occur, will be entered into the internet crf form, by the treating physician or a person from his staff specifically appointed to this task. patient enrollment is anticipated to last 8 months.

Eligibility criteria:
inclusion criteria: 1. niddm treated with oral antidiabetics for at least 3 months, or iddm treated for at least 3 months with documented hba1c; 2. diagnosis of angina pectoris as defined by canadian cardiovascular society classification (ccs i, ii, iii, iv) or unstable angina pectoris (braunwald classification b i-ii) or patients with documented silent ischemia; 3. target lesion stenosis is \>50% (visual estimate); 4. target vessel diameter, between 2.5 and 3.0 mm 5. target lesion length minimum 15 mm and maximum 30mm exclusion criteria: 1. ck and ck-mb enzymes above normal or elevated troponin level (as determined by site criteria) at the time of treatment; 2. has unstable angina classified as braunwald iii b and a or c i-ii-iii, or is having a peri-infarction; 3. unprotected left main coronary disease with \>=50% stenosis; 4. significant (\>50%) stenosis proximal or distal to the target lesion that might impede inflow or runoff and can not be revascularized before or during the index procedure; 5. have an ostial target lesion; 6. documented left ventricular ejection fraction \<=30%; 7. in-stent restenosis; 8. chronic total occlusion.
efficacy study of atorvastatin to treat variant angina

Conditions: Angina Pectoris, Variant

Summary: the objective of this study is to evaluate effect of statin treatment for vasospastic angina.

vasospastic angina is presented by myocardial ischemia with spasm of coronary artery accompanying chest pain or discomfort. the precise mechanisms have not been established, but a reduction in no (nitric oxide) production, an imbalance between endothelium-derived relaxing and contracting factors,or an injury of endothelium have been suggested. impaired fmd(flow mediated endothelium-dependent vasodilation) in the brachial artery was demonstrated in vasospastic angina,and improvement of endothelial dysfunction with treatment of statin is documented in several studies. so, we expect that statin treatment for vasospastic angina provide additional therapeutic effects via improvement of endothelial dysfunction.

Eligibility criteria:
inclusion criteria: * vasospastic angina or spontaneous spasm during coronary angiography (vasospastic angina is defined as thrombolysis in myocardial infarction (timi) flow grade 0-2 noted in intracoronary ergonovine provocation test and development of chest pain or ekg change; spontaneous spasm is defined as timi flow grade 0-2 of coronary artery without ergonovine injection) * normal or insignificant lesion (diameter stenosis \<50%) on coronary angiography exclusion criteria: * elevated liver enzyme: serum aspartate aminotransferase or alanine aminotransferase concentrations more than 3 times the upper limit of normal * significant lesion( diameter stenosis ≥50%) documented in coronary angiography * pregnancy * prior percutaneous coronary intervention or coronary artery bypass surgery * previous statin use * impaired renal function with serum creatinine ≥ 2.0 mg/dl * severe left ventricular dysfunction ( lvef ≤ 30% on echocardiography) * myopathy

Keywords: atorvastatin angina pectoris, variant endothelial dysfunction
a study of amg 820 in subjects with advanced solid tumors

Conditions: Advanced Malignancy; Advanced Solid Tumors; Cancer; Oncology; Oncology Patients; Tumors

Summary: first in human, open-label, sequential dose escalation and expansion study of amg 820 in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * men or women ≥ 18 years old * subjects must have a pathologically documented, definitively diagnosed, advanced solid tumor * measurable disease per recist 1.1 guidelines * eastern cooperative oncology group (ecog) performance status of ≤ 2 * part 2 - dose expansion only: subjects must have tumor tissue that is accessible for core needle biopsy by using minimally invasive procedures and must consent to undergo biopsies of the tumor * able to fast 4 to 6 hours for fdg-pet/ct scan, except subjects with prostate or bladder cancers * competent to sign and date an institutional review board approved informed consent form * adequate hematologic, renal and hepatic function as determined by laboratory blood and urine tests exclusion criteria: * men and woman of reproductive potential, unwilling to practice a highly effective method of birth control for the duration of the study and an additional 4 months after receiving the last dose of study drug. * women who are lactating/breastfeeding or planning to become pregnant during the duration of the study * primary central nervous system (cns) tumors or cns metastases * history of presence of hematological malignancies * history of arterial or venous thrombosis within 6 months of study enrollment * history of bleeding diathesis * myocardial infarction within 6 months of study day 1, symptomatic congestive heart failure (new york heart association \> class ii), unstable angina, or unstable cardiac arrhythmia requiring medication, or uncontrolled hypertension * hypertension not adequately controlled with medication (diastolic \> 90mmhg; systolic \> 140 mmhg) * left ventricular ejection fraction (lvef) ≤ 50% * active infection requiring (iv) antibiotics within 2 weeks of study enrollment * known positive test for human immunodeficiency virus (hiv) * known chronic hepatitis b or hepatitis c infection * positive test for hepatitis b surface antigen or hepatitis c antibody * known history of tuberculosis (tb), exposure to active tb-infected individuals, or positive tb skin test (tuberculin or purified protein derivative (ppd) test) upon study entry (subjects previously vaccinated for tb are not excluded unless there is evidence of active tb) * anti-tumor therapy within 4 weeks of study day 1 including chemotherapy, antibody therapy, retinoid therapy, or other investigational agent * concurrent or prior anticoagulation therapy within 28 days of study day 1 * major surgery within 28 days of study day 1 * any co-morbid medical disorder that may increase the risk of toxicity, in the opinion of the investigator or sponsor

Keywords: solid tumors phase 1 clinical trial
the safety and efficacy of using hyadermis la for wrinkle correction

Conditions: Pain; Nosalabial Folds Correction

Summary: the study is a double-blind, randomized, within-subject controlled, 2-armed, single-centre study sponsored by scivision biotech inc. and approved by yuan's general hospital institutional review board. the aim of this post-marketing study is to evaluate the safety and efficacy of hyadermis la facial dermal implant for the improvement of nasolabial folds. the study was estimated to be held half to one year including a 0-2 weeks screening period, a day of treatment, and follow-up at week 1 and 2. patient informed consent forms will be obtained before volunteers enter screening period. if the volunteers meet all the criteria, they will be given a number to replace their name in the study. the participants will be randomised assigned to receive experiment treatment, hyadermis la, in one side of nasolabial folds and control treatment, hya-dermis, in the other side of the face. the safety assessment evaluated any recorded adverse events following the device treatments either by blinded evaluator or subjects. the effectiveness of the treatment devices will be assessed by using photographic assessment, nasoalabial folds severity scale, global aesthetic improvement scale, and pain visual analog scale.


Eligibility criteria:
inclusion criteria: * be 25 to 60 years of age and of any sex who is willing to receive nasolabial folds correction by intradermal injection procedures * have approximately symmetrical nasolabial folds with a nasolabial folds severity grade of 2-4 and the grade difference between two sides is less than 1 * agree to refrain from undergoing invasive aesthetic treatments in the injective areas 12 months after the injections * agree to refrain from undergoing other physical or chemical aesthetic treatments in the injective areas 3 months after the injections * if female of child-bearing potential, not be breastfeeding, have a negative urine pregnancy test on the treatment day and agree to use any approved contraceptives or medically acceptable method of birth control throughout the study * have ability to understand and comply with the study requirements, and provide the written informed consent prior to any procedures exclusion criteria: * have history or active dermal diseases, inflammation, or any related disease * had permanent or semi-permanent implantation on nasolabial areas * had invasive aesthetic treatments or surgeries history 6 months before the treatments * had physical or chemical aesthetic treatments 1 months before the study starts * have history of coagulation defect diseases and still take aspirin, anticlotting, or blood activating medications 1 week before the treatments * have adams-stokes syndromes, wolff-prkinson-white syndromes, severe sinus node, the atrioventricular node dysfunction, or the blocked ventricular * have a known history of allergic reactions like hypersensitivity to hyaluronic acid * have a known history of allergic reactions like hypersensitivity to lidocaine or other anaesthetics * have poor compliance with the study or follow-up schedule
the metabolic effects of cynara supplementation in overweight and obese class i subjects with newly detected impaired fasting glycaemia.

Conditions: Insulin Sensitivity; Obesity; Overweight

Summary: impaired fasting glucose (ifg) is a condition that precedes diabetes and increases the risk of developing it. studies support the hypoglycemic effect of cynara cardunculus (cs) extracts due to the content of chlorogenic acid, which is a potent inhibitor of glucose 6-phosphate translocase and of dicaffeoylquinic acid derivatives that modulate the activity of alpha-glucosidase. given this background, we investigated whether a new highly standardized cs extract could improve glycaemic control, insulin sensitivity and other metabolic parameters (total, hdl and ldl cholesterol, triglycerides, apob, apoa, waist circumference, visceral adipose tissue by dxa) in overweight subjects with newly diagnosed ifg.


Eligibility criteria:
inclusion criteria: * without history of cardiovascular disease (cvd), * not taking any medication likely to affect glucose or lipid metabolism (oral hypoglycemic agents and statins) * free of overt liver, renal and thyroid disease exclusion criteria: * smoking * drinking more than two standard alcoholic beverages/day (20 g of alcohol/day)

Keywords: impaired fasting glucose cynara cardunculus insulin sensitivity obesity overweight
uncontrolled lower respiratory symptoms in the wtc survivor program

Conditions: Lung Diseases; Medication Compliance

Summary: the purpose of this study is to understand why patients in the world trade center program have continuing breathing problems. this study will improve investigators understanding of breathing problems among individuals with world trade center exposure by allowing them to review and monitor medication use, lung function, and examine other conditions that can contribute to problems with breathing. the findings from the study will help investigators understand why some people have persistent lower respiratory symptoms (breathing problems) after their exposure to world trade center dust and fumes, and may help guide better management and treatment of these symptoms.

investigators will conduct a clinical study with aggressive treatment for lower respiratory symptoms in patients in the world trade center environmental health center. patients in the wtc ehc with uncontrolled lrs at visit 1 will be identified and placed on high-dose inhaled corticosteroids and long-acting beta agonists for three months. adherence will be assessed at monthly visits. patients will perform spirometry and oscillometry at baseline and after 3 months of treatment. they will also be assessed for markers of airway inflammation, bronchial hyperresponsiveness and co-morbid conditions including depression,anxiety,post-traumatic stress disorder, gastroesophageal reflux, paradoxical vocal cord motion and rhinosinusitis.

Eligibility criteria:
inclusion criteria: * age ≥18 years and \<75 * meet criteria for world trade center environmental health center enrollment * onset of lower respiratory symptoms after 9/11/01 * persistent lower respiratory symptoms (\> 2 times per week) * pre-bronchodilator forced expiratory volume in one second (fev1) within normal limits * \< 5 pack-year tobacco history * not current smoker * asthma control test score ≤ 19 * normal chest x-ray exclusion criteria: * age \< 18 years and ≥75 * lower respiratory symptoms or asthma history pre 9/11/01 * no persistent lower respiratory symptoms * pre-bronchodilator fev1 within normal limits * \> 5 pack year tobacco * current smoker * abnormal chest x-ray or parenchymal changes on high resolution computed tomography * uncontrolled major chronic illness (diabetes mellitus, congestive heart failure, cancer) * history of significant non-world trade center occupational or environmental exposure * allergy to study drug * pregnancy, lactation or plans to become pregnant * chronic oral corticosteroid use * high risk of fatal or near-fatal asthma within the previous 2 years * other lung disease (idiopathic pulmonary fibrosis,sarcoid, etc.)

Keywords: world trade center disaster environmental exposure respiratory physiology inflammation gastrointestinal diseases sinus symptoms ptsd anxiety depression hypersensitivity spirometry oscillometry
the efficacy and safety of erdosteine in chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease (COPD)

Summary: the aim of the study is to evaluate the effect of erdosteine, compared to placebo, on exacerbation rate over a 12-month treatment period in patients with moderate-to-severe copd. moreover, the effects of erdosteine on pulmonary function parameters, clinical symptoms and quality of life, and the long-term safety of the drug will be assessed.


Eligibility criteria:
inclusion criteria: * copd stage ii-iii gold * at least 2 exacerbations in the previous 2-12 months exclusion criteria: * acute exacerbations in the 2 months prior to enrolment * diagnosis of asthma and/or other relevant lung diseases * copd stage iv * unstable concurrent diseases