Kornimate/medical-research-clean huggingface dataset:
study of aldafermin (ngm282) in subjects with compensated cirrhosis (alpine 4)

Conditions: Compensated Cirrhosis; Nonalcoholic Steatohepatitis

Summary: a multi-center evaluation of aldafermin in a randomized, double-blind, placebo-controlled study in subjects with compensated cirrhosis.

the study will compare multiple doses of aldafermin against placebo in a compensated nash cirrhosis population for 48 weeks of treatment.

Eligibility criteria:
key inclusion criteria: 1. liver biopsy consistent with nash cirrhosis. 2. compensated cirrhosis due to nash. key exclusion criteria: 1. other causes of liver disease including but not limited to alcoholic liver disease, hepatitis b, hepatitis c, autoimmune disorders, primary biliary cirrhosis, drug-induced hepatotoxicity, wilson's disease, hemochromatosis, and alpha-1-anti-trypsin definition based on medical history and/or centralized read of liver histology. 2. evidence of drug induced steatohepatitis secondary to amiodarone, corticosteroids, estrogens, methotrexate, tetracycline, or other medications known to cause hepatic steatosis. 3. history of hepatic decompensation including variceal bleeding, ascites, or hepatic encephalopathy. 4. model of end stage liver disease (meld) score \>12. other protocol-defined inclusion/exclusion criteria could apply.
prevention of unexplained recurrent abortion by enoxaparine

Conditions: Alive and Viable Births

Summary: standard investigations fail to reveal any apparent cause in 50% of the cases of recurrent spontaneous abortion. prothrombotic mechanisms were initially evoked. factor v leiden, prothrombin g20210a mutation and protein s deficiency are implicated in the meta-analysis of rey (lancet).however, they do not account for a large number of miscarriages.gris jc and coworkers (blood 2004)carried out an open trial, low-molecular-weight heparin versus low-dose aspirin, in women with one fetal loss and with a constitutional thrombophilic disorder. they conclude for a benefit action of low-molecular-weight heparin. there is actually no trials concerning women with unexplained recurrent abortions and without known thrombophilia. nevertheless,aspirin or enoxaparin are often prescribed. it is time to assess these practices. we therefore initiate a multisite, double blind randomized study, enoxaparine versus placebo, in women without known thrombophilia, which experienced unexplained recurrent abortions.


Eligibility criteria:
inclusion criteria: * women between 18 and 45 years * 2 or more consecutive spontaneous abortions before the 15th week of pregnancy * unexplained abortions * no maternal or paternal characterized chromosomal aberration * no anti-phospholipid syndrome * no anatomical abnormality possibly responsible for abortion * no factor v leiden * no prothrombin g20210a mutation * no protein s deficiency * no protein c deficiency * no anti thrombin 3 deficiency * proved pregnancy exclusion criteria: * contraindications of enoxaparine 4000 u per day * women with risk of venous thromboembolism during pregnancy * no regular anticoagulation or antiplatelet treatment * blood hemoglobin level below 10g/dl * blood platelet level below 150 000/mm3 * creatinine clearance below 30ml/mn * anomaly of the coagulation tests * no informed consent
emergency department rapid intravenous rehydration (rivr) for pediatric gastroenteritis

Conditions: Gastroenteritis; Dehydration

Summary: this study will look at children with dehydration secondary to gastroenteritis requiring iv rehydration and determine whether the proportion rehydrated after two hours is greater in the children who receive rapid intravenous rehydration (rivr) or in the children who receive standard iv rehydration.

despite a movement toward increased use of enteral rehydration, many children still receive prolonged iv rehydration in the emergency department (ed). these children commonly receive a single iv bolus of normal saline followed by the administration of a hypotonic solution at a maintenance rate. the mean time spent in the ed by children receiving iv rehydration is significantly longer than the mean time required to treat all other conditions. ed overcrowding has been associated with poor outcomes, prolonged pain and suffering, and dissatisfaction. one of the solutions proposed in the american academy of pediatrics policy statement on ed overcrowding is that hospitals should strive to improve the efficiency of the care provided. one small step in this direction may be to improve our management of gastroenteritis and dehydration.

Eligibility criteria:
inclusion criteria: * acute gastroenteritis as determined by the supervising physician. * age greater than 90 days * dehydrated and unable to consume sufficient oral fluids to overcome their dehydration state exclusion criteria: * weight less than 5 kg or greater than 33 kg * underlying disease which may limit the amount of iv fluids given,including but not limited to: hypoalbuminemic states, renal insufficiency, heart disease requiring pharmacotherapy or lesions that may predispose to congestive heart failure, hypertension, chronic lung disease (excluding asthma), diabetes mellitus, severe anemia, and chronic inflammatory disease * clinical suspicion by the attending physician of myocarditis or previously undiagnosed cardiac or renal disease. * history of abdominal surgery or concern regarding an acute surgical abdomen * significant head, chest or abdominal trauma within the preceding 7 days * bilious or bloody vomitus * evidence of hemodynamic compromise (bp \ 20 ml/kg 0.9% normal saline to be administered in the 1st hour * bedside glucose \< 2.8 mmol/l (see section 8.3) * unable to provide a telephone number or unavailable for follow-up * previously enrolled in this trial

Keywords: pediatrics gastroenteritis dehydration iv rehydration
association study between periodontal disease and male infertility

Conditions: Periodontitis; Sub-fertility

Summary: the aim of the present study is to examine the association between fertility parameters and the periodontal status of men attending fertility and in vitro fertilization clinic.

an association has been found between periodontal diseases and preterm low birth weight, coronary heart disease, and cerebral infarction. anaerobic gram negative bacterial plaque that forms subgingivally is the direct causative factor for the development of gingivitis and periodontitis. however, its possible association with male infertility have not yet been investigated.

Eligibility criteria:
inclusion criteria: * consent to participate in study exclusion criteria: * systemic uncontrolled disease
a study of fz-ad004 in patients with advanced solid tumors

Conditions: Advanced and Metastatic Solid Tumor

Summary: this study is one single group of participants with advanced solid tumors. it is the first time the drug has been used in humans. there will be two parts including dose escalation and dose expansion to evaluate the safety, tolerability, pharmacokinetics, and clinical activity of fz-ad004.

this is a first-in-human (fih), phase 1, open-label, dose escalation and dose expansion study to evaluate the safety, tolerability, pharmacokinetics and preliminary efficacy of fz-ad004 in patients with advanced/metastatic solid tumors. fz-ad004 is administered via intravenous infusion using an accelerated titration method followed by a conventional 3 + 3 study design to identify the maximum tolerated dose (mtd) and dose-limiting toxicities（dlt）during cycle 1. in addition, the maximum-tolerated dose and recommended phase ii dose for fz-ad004 will be determined.

Eligibility criteria:
inclusion criteria: 1. patients able to give written informed consent; 2. age ≥ 18 and ≤ 75 years old, male or female; 3. patients have histological or cytological diagnosis with advanced solid tumors. 4. have measurable lesions defined in recist v. 1.1; 5. expected survival ≥ 12 weeks; 6. eastern cancer cooperative group (ecog) performance status 0-1; 7. patients of child bearing potential must agree to take contraception during the study and for 6 months after the last day of treatment. exclusion criteria: 1. have had other malignant tumors in the past 5 years; 2. have cns (central nervous system) metastasis with clinical symptoms; 3. had undergone major surgery or severe trauma within 4 weeks prior to the first dose; 4. had undergone systemic high-dose steroids within 2 weeks of initiation of study treatment; 5. have history of psychotropic drug abuse, alcohol or drug abuse； 6. women who are pregnant or lactating； 7. other circumstances that is deemed not appropriate for the study.

Keywords: advanced and metastatic solid tumor
balanced crystalloid solutions for acute pancreatitis

Conditions: Acute Pancreatitis

Summary: patients diagnosed with acute pancreatitis regardless of etiology, severity of disease, and prior attacks will be randomized in two groups. the intervention group will receive a balanced crystalloid (plasmalyte) at a rate of 10 ml/kg during the first 60 min and then continued at 3 ml/kg/h for the next 72 hours. the control group will receive normal saline at the same rate.


Eligibility criteria:
inclusion criteria: - patients diagnosed with acute pancreatitis based on the revised atlanta criteria who present to our hospital within 48 hours of symptoms onset, regardless of etiology, severity of disease, or prior episodes of acute pancreatitis exclusion criteria: * chronic pancreatitis * liver cirrhosis (child-pugh b and c) * chronic hearth failure (nyha\>ii) * acute coronary syndrome * cardiovascular intervention within 60 days before randomization * chronic obstructive pulmonary disease dependent of home oxygenator or acute exacerbation of chronic obstructive pulmonary disease * chronic kidney disease (egfr \<30 ml/min/1.73 m2) * concomitant biliary infection (cholecystitis, cholangitis) * severe autoimmune disease * chronic active infection (tbc, aids) * metastatic malignant disease * primary pancreatic neoplasm * patients transferred from other hospitals * pregnancy and ongoing breastfeeding * not willing to participate
the effects of repetitive transcranial magnetic stimulation in patients with alzheimer's disease

Conditions: Alzheimer Disease

Summary: objectives: the purpose of this study was to investigate the effects of high-frequency repetitive transcranial magnetic stimulation (rtms) in alzheimer's disease (ad). methods: twenty-seven ad patients aged ≥60 years were included in the study and divided into 3 groups (rtms, aerobic exercise (ae) and control). all groups received pharmacological treatment. rtms group (n=10) received 20 hz rtms treatment on bilateral dorsolateral prefrontal cortex, 5 days a week over 2 weeks, and ae group (n=10) received the moderate-intensity aerobic exercise for 50 min sessions, 5 days a week over 2 weeks. control group (n=10) was only treated pharmacologically. neuropsychiatric and behavioral status, cognition, balance, functional mobility, and quality of life, and functional brain changes were evaluated before and after the treatment.


Eligibility criteria:
inclusion criteria: * having clinical ad diagnosis according to the nincds-adrda (national institute of neurological and communicative diseases and stroke/alzheimer's disease and related disorders association) criteria * being 60 years and older * having clinical dementia rating scale (cdr) scores 1 or 2 * living independently exclusion criteria: * not being able to walk independently, * having physical disabilities, * having a history of alcohol / substance abuse, * having head trauma * having epileptic seizures

Keywords: alzheimer's disease repetitive transcranial magnetic stimulation cognitive function aerobic exercise functional mri resting state networks
telepsychiatry to enable expedited disposition of psychiatric emergencies

Conditions: Psychiatric Emergency

Summary: the goal of this observational study is to examine the effect of using a video link for evaluation of patients in the psychiatric emergency room. under current israeli law, the attending physician must come in to physically examine the patient before they can be admitted involuntarily. patients often de-compensate and even may become violent while waiting for the attending to arrive. previous studies have shown that evaluation of such patients via video-link has an extremely high concordance with in person evaluation. this study will compare patients who are evaluated via video-link with historical controls evaluated under usual conditions. this is an observational study, which is taking advantage of a change in practice to collect data on two different ways of delivering care, via chart reviews. if successful, this study will show that the video-link is feasible and acceptable to patients and staff. the following hypotheses will be tested: 1. the intervention will result in shorter ed time compared to historical controls. 2. the intervention will result in fewer violent incidents compared to historical controls. 3. the intervention will result in shorter overall hospital length of stay compared to historical controls.


Eligibility criteria:
inclusion criteria: * must be evaluated in the psychiatric ed for potential involuntary admission exclusion criteria: * not justice-involved (i.e., brought in by police after committing a crime)

Keywords: telepsychiatry implementation science
ophtai diagnostic performance validation for automated screening of eye diseases

Conditions: Diabetic Retinopathy; Diabetic Macular Edema; Age-Related Macular Degeneration; Age-related Maculopathy; Glaucoma

Summary: evolucare ophtai is a medical device offering automated, artificial intelligence powered, screening capabilities for diabetic retinopathy, diabetic macular edema, glaucoma, arm and amd, whose performances will by tested through the ophtai-eval.

ophtai-eval: is a prospective, multicentre, post-marketing clinical follow-up study (scac) of diagnostic validation (comparative vs gold standard). it aims to: validate the diagnostic performance of the ophtai software for the automated screening of diabetic retinopathy, diabetic macular edema, glaucoma, arm and amd. evolucare ophtai is a medical imaging console for ophthalmology, interfaced with evolucare imaging. it allows the detection, by statistical learning algorithms, of the following ocular pathologies using photographs of the retina: * diabetic retinopathy (dr) (including gradation), * diabetic macular edema (dme) * age-related macular degeneration (amd) * age-related maculopathy (arm, early form of amd), * glaucoma. evolucare ophtai, is available on the french market since march 2019.

Eligibility criteria:
doesn't not accept healthy volunteers as diabetic patients are needed, still they may be free of any eye diseases. inclusion criteria: the characteristics required for a subject to take part in the research are * male or female over 18, * type 1 or 2 diabetic, * presenting for screening for diabetic retinopathy, * beneficiary of a social security scheme, * for whom written consent has been obtained for participation in the protocol. exclusion criteria: the following characteristics do not allow the subject to take part in the research: * patient with known dr, more severe than "minimal", including having been treated, * any other condition that, in the opinion of the health professionals, may interfere with their ability to complete the study or may present a significant risk, * presence of social, medical and/or psychological factors that may compromise the patient's adherence to the protocol, * simultaneously participating in another clinical research protocol or having recently participated in another research study for which the exclusion period would not be completed. patients who participate in this research will not be able to participate in another research at the same time. however, there is no exclusion period at the end of this research for participation in any other study.

Keywords: ophtai artificial intelligence computer-aided diagnosis automated screening medical device diabetic patient diabetic retinopathy diabetic macular edema age-related macular degeneration age-related maculopathy glaucoma evolucare ophtai
weight maintenance with dipeptidyl peptidase 4 (dpp4) inhibitor sitagliptin in combination with metformin after liragludite induced weight loss

Conditions: Polycystic Ovary Syndrome; Body Weight

Summary: weight reduction is the most important treatment target in obese women with polycystic ovary syndrome (pcos), yet it is usually hardly achievable with lifestyle intervention alone. glucagon-like peptide 1 (glp-1) receptor agonist (ra) liraglutide was recently approved as an anti-obesity drug but with some limitations, which include high cost and the lack of long-term efficacy and safety data regarding weight reduction. in addition, weight loss achieved with liraglutide is often non-sustainable after treatment cessation. although dpp-4 inhibitors are weight neutral, they reduced weight regain in animals previously treated with glp-1 ras if they were switched to dpp-4 inhibitor rather than placebo. the aim is to evaluate whether dpp-4 inhibitor sitagliptin in combination with metformin reduce body weight regain more effectively than metformin alone in obese pcos who had been previously treated with liraglutide.


Eligibility criteria:
inclusion criteria: * 18 years old to menopause * polycystic ovary syndrome (nichd criteria) * bmi of 30kg/m2 or higher exclusion criteria: * type 1 or type 2 diabetes mellitus * history of carcinoma * cushing's syndrome or congenital (non-classic) adrenal hyperplasia * personal or family history of multiple endocrine neoplasia type 2 * significant cardiovascular, kidney or hepatic disease * the use of statins, within 90 days prior to study entry

Keywords: dpp4-inhibitors
randomised controlled trial of the effect of music on women undergoing assisted reproductive technology treatments.

Conditions: Anxiety

Summary: to investigate whether listening to music at the time of embryo transfer reduces anxiety levels in women undergoing assisted conception treatment.

an assessor-blinded randomized case control study in an ivf center, england uk will randomise women into 'music' (listened to self-selected music during embryo transfer) or 'control' (no music) groups. participants will complete the spielberger state-trait anxiety inventory prior to, and immediately following a post-treatment observation period. total scores will be compared.

Eligibility criteria:
inclusion criteria: eligible participants were women aged between 25-40 years, undergoing ivf or icsi with fresh or frozen embryos to completion from february 2013 to december 2013. exclusion criteria: women unable to consent or with hearing impairment were excluded.

Keywords: music, anxiety, ivf
cancer/testis antigen immunotherapy phase i study with 740-cta vaccinia virus

Conditions: Breast Carcinoma

Summary: monocentric open-label phase i/ii trial aiming at evaluating, in adjuvant setting, safety (primary outcome), immunological and clinical efficacy (secondary outcomes) of a non replicating recombinant vaccinia virus expressing cancer/testis antigen (cta) derived epitopes and cd80 and cd40 ligand (cd40l, cd154) costimulatory molecules in patients with cta expressing tumors.


Eligibility criteria:
inclusion criteria: * surgically treated m0 patients with solid tumors * tumor expressing at least one of the vaccine targeted antigens melanoma-associated antigen (mage)-a1, -a2, * a3, -a4, -a6, -a10, -a12 or new york (ny) esophageal squamous cell carcinoma-1 (eso-1) (ny-eso-1) (by real-time quantitative pcr (rt-qpcr)) * patient expressing the targeted human leukocyte antigen (hla) restriction (a0201 /a0101/ b3501) * 4 weeks interval following surgical resection of tumor and, if applicable, completion of adjuvant therapy. * karnofsky over 70% * no other concomitant malignancy exclusion criteria: * history of anaphylaxis or severe allergic reaction * severe heart, lung, kidney, liver or psychiatric condition * concurrent immunosuppressive therapy or impaired immune system
incidence & clinical significance of osteolysis following peek suture anchor use in hand & wrist surgery

Conditions: Osteolysis

Summary: this prospective observational study evaluates the incidence \& clinical significance of osteolysis following polyetheretherketone (peek) suture anchor use in hand \& wrist surgery. building on a pilot study, it focuses on patients undergoing hand \& wrist surgeries with suture anchor implantation over the past 10 years. patients are grouped by anchor composition: peek, metallic, or bioabsorbable. we hypothesize that peek anchors will show significantly greater osteolysis than metallic or bioabsorbable anchors. furthermore, among all patients with osteolysis, we expect no statistically significant differences in patient-reported outcomes (pros), post-op complications, or revision surgery rates, regardless of anchor type. lastly, for patients with ulnar collateral ligament (ucl) thumb injuries, we hypothesize that osteolysis presence will not correlate with increased ucl laxity upon valgus stress testing compared to the nonoperative thumb.


Eligibility criteria:
inclusion criteria: * male or female aged 18 - 99 years-old * history of hand and/or wrist surgery with suture anchor fixation over the 10-year period between january 1, 2014 and january 1, 2024. * possess an en face and/or tangential radiograph of the suture anchor tunnels from either the intra-operative or immediately post-operative (within 14 days) period. exclusion criteria: * systematic inflammatory / autoimmune disease or immune-modulatory drug use. * history of revision surgery of the body part of interest.
to evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.

Conditions: Seizure Disorder, Partial

Summary: to evaluate long-term safety and efficacy of pregabalin in patients with partial seizures.


Eligibility criteria:
inclusion criteria: * must have met the inclusion criteria for preceding double-blind study * have received double-blind study medication and wish to receive open-label pregabalin. exclusion criteria: * cannot have absence seizures