Kornimate/medical-research-clean huggingface dataset:
assessment of telomerase activity in endometrial tissue and serum in endometriosis patients

Conditions: Endometriosis Ovaries; Infertility, Female

Summary: the goal of the study was the detection of telomerase activity in eutopic, ectopic endometrial tissue and in peripheral blood and finding the correlation between the telomerase activity and clinic findings. with these results, confirmation of the hypothesis regarding the endometriosis pathogenesis and endometriosis-related infertility was aimed.

although distorted pelvic anatomy, impaired peritoneal, humoral and cellular functions, decreased implantation rate, oocyte and embryo quality, obstructed utero tubal connection are most researched aspects of endometriosis-related infertility, etiopathogenesis of endometriosis-related infertility still remains controversial. endometrial cell is a unique eukaryotic somatic cell with cyclic telomerase activity. hormone-dependent cyclic variation of endometrial telomerase activity was stated in previous studies. on the other hand telomerase, activity was shown in endometriotic lesions, whereas this activity lacks in most of the somatic cells. in this study, assessment of possible relation to increased telomerase activity in infertile patients with endometriosis was aimed. before published studies were assessed telomerase activity in benign and malign gynecological conditions and in endometriosis tissue, as well. but evaluation of ectopic and eutopic endometrial tissue and serum telomerase activity in infertile and fertile endometriosis and healthy control subjects was not performed. correlation of telomerase activity and endometriosis-related infertility was aimed in this study.

Eligibility criteria:
inclusion criteria: clinical diagnosis of infertility clinical and histological diagnosis of endometriosis exclusion criteria: malign disorders hormone replacement treatment oral contraceptive using

Keywords: endometriosis infertility telomerase activity
clinical study to evaluate efficacy and safety of allo-asc-dfu in patients with diabetic foot ulcers.

Conditions: Diabetic Foot Ulcer

Summary: this is a phase iii double-blind study to evaluate the efficacy and safety of allo-asc-dfu in patients with diabetic foot ulcer, compared to placebo therapy.

experimental: allo-asc-dfu, placebo comparator: vehicle sheet, study type: interventional, study design: randomized, placebo-controlled, double-blind, parallel-group, multi-center study

Eligibility criteria:
inclusion criteria: 1. subject is between 18 and 75 years of age. 2. subject is diagnosed with type i or type ii diabetics and has diabetic foot ulcers for longer than 4 weeks at the screening visit. 3. foot ulcer size is between 1 cm2 and 15 cm2 4. ulcer graded i or ii by wagner grade, and extended to skin, tendon, and subcutaneous tissue. 5. free of necrotic debris at target ulcer 6. around ulcer area blood circulation should be secured to meet one of below criteria; * blood vessels around the ulcer detected by doppler test * 0.7 \< ankle brachial index(abi) \< 1.3 * transcutaneous oxygen pressure, tcpo2 higher than 30 mmhg 7. subject is able to give written informed consent prior to study start and to comply with the study requirements during study. exclusion criteria: 1. non-diabetic pathophysiologic ulcer. 2. the ulcer has increased or decreased in size by 30% or more during one week after the screening visit. 3. subjects requiring intravenous (iv) antibiotics to treat infection. 4. current evidence of infection including pus drainage from the wound site. 5. subject has a glycated hemoglobin a1c (hba1c) level of \> 15% 6. subject's blood sugar is \> 450 mg/dl at postprandial. 7. subjects with severe renal failure that cannot be managed by renal dialysis. 8. subjects with severe hepatic deficiencies. 9. subject is human immunodeficiency virus (hiv) positive. 10. subject who has allergic or hypersensitive reaction to bovine-derived proteins or fibrin glue. 11. subject who is pregnant or breast-feeding. 12. subjects who are unwilling to use an "effective" method of contraception during the study. 13. subjects who have a clinically relevant history of alcohol or drugs abuse. 14. subjects who are not able to understand the objective of this study or to comply with the study requirements. 15. subjects who are considered to have a significant disease which can impact the study by investigator. 16. subjects who are considered not suitable for the study by investigator. 17. subjects who had had a history of surgery for malignant tumor within the last five years (except carcinoma in situ). 18. subjects who are currently or are enrolled in another clinical study within 60 days of screening. 19. subjects who have undergone wound treatments with growth factors, dermal substitutes, or other biological therapies within the last 30 days. 20. subjects who are receiving oral or parenteral corticosteroids, immunosuppressive, or cytotoxic agents with unstable dose prior to 4 weeks from screening. 21. subjects not comply with off-loading procedure
a observational study to compare effectiveness and safety of the surgeries in patients with esophageal cancer

Conditions: Esophageal Cancer

Summary: the study was designed to compare effectiveness and safety of the surgeries of ivor-lewis and mckeown in patients with esophageal cancer

the trial is a multi-centre real-world non-interventional observational study. the study was designed to compare effectiveness and safety of the minimally invasive surgeries of ivor-lewis and mckeown in the chinese patients with ia-iiib esophageal cancer via a retrospectively review method based on the study data on patient demographic/tumor biological characteristics and clinical treatments.

Eligibility criteria:
inclusion criteria: * pathologically diagnosed middle and lower thoracic ia-iiib esophageal cancer after surgeries; * patients who received minimally invasive radical dissections of ivor-lewis and mckeown; * patients who received tubular gastroesophageal reconstruction; exclusion criteria: * patients complicated with arrhythmia, or serious disfunctions of heart, lung, liver, and kidney before surgeries; * patients with second primary tumors; * patients who received abdominal or thoracic surgeries; * patients who received gastrostomy or nesteostomy before surgeries; * patients with suspected cervical lymph metastases (in the subgroup of the patients who received the surgery of mckeown)

Keywords: chinese, esophageal cancer, surgeries of ivor-lewis/mckeown
optimal dose escalation strategy to successful achievement of high dose donepezil 23mg

Conditions: Alzheimer's Disease

Summary: this study evaluates the side effects of dose escalation in the treatment of donepezil 23mg for patients with alzheimer's disease. investigators randomly divide participants into three groups according to the dose escalation method; no titration, 15mg of donepezil for a month before escalation to 23mg, and alternating of 10mg and 23mg for a month before escalation to 23mg.

high dose of donepezil is currently prescribed for patients with alzheimer's disease who showed poor response in lower dose, however the side effect profiles according to dose titration method were not clarified yet. this study aims to confirm which titration method would show better safeties and tolerabilities in the high dose donepezil treatment. investigators include patients with moderate to severe dementia who were diagnosed as probable alzheimer's disease and treated with donepezil 10mg at least 3 months before the study. the study duration is for 12 weeks and the titration duration is the first 4 weeks of the study. investigators evaluate the side effects profiles and vital signs at every 4 weeks and measure blood laboratory tests at screening and the last visit.

Eligibility criteria:
inclusion criteria: * dementia according to diagnostic and statistical manual of mental disorders (dsm)-iv criteria * probable alzheimer's disease dementia according to national institute on aging-alzheimer's association (niaaa) criteria * mini-mental state examination (mmse) score of 20 or less * general deterioration scale (gds) score of 4 or more / clinical dementia rating (cdr) score of 2 or more * stable dose of 10mg donepezil at least 3 months before screening * caregiver who can come together at every visit and give informations about side effects profiles should exist * patients and caregivers accepted the study exclusion criteria: * patients receiving other concomitant acetylcholinesterase inhibitor * uncontrolled psychiatric disorders * drug overuse or alcohol abuse history within 5 years * significant uncontrolled or active medical conditions * uncontrolled epilepsy * patients who cannot come at scheduled visits

Keywords: alzheimer's disease donepezil
a study evaluating the safety and efficacy of otx-dp for the treatment of allergic conjunctivitis

Conditions: Allergic Conjunctivitis

Summary: the objective of the study is to evaluate the efficacy and safety of otx-dp as a dexamethasone ophthalmic insert when placed in the canaliculus of the eyelid for the treatment of the signs and symptoms of allergic conjunctivitis.


Eligibility criteria:
inclusion criteria: * has a positive history of ocular allergies and a positive skin test reaction to a perennial allergen and a seasonal allergen * has a positive bilateral cac reaction to a perennial allergen within minutes of instillation exclusion criteria: * history of refractive surgery (including lasik procedures) within the past 2 years * history of retinal detachment, diabetic retinopathy, or active retinal disease * presence of an active ocular infection or positive history of an ocular herpetic infection at any visit * history of iop increase as a result of steroid treatment * a female who is currently pregnant, planning a pregnancy, or lactating
ingested interferon alpha: prolongation or permanence of the "honeymoon" phase in newly diagnosed type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: we hypothesize that ingested human recombinant interferon-alpha (hrifn-a) will prolong the "honeymoon" period and enhance b cell survival in type 1 diabetes in a phase ii randomized, placebo-controlled, double-blind clinical trial. we have demonstrated that ingested ifn-a prevents type 1 diabetes in the nod mouse, prolongs the "honeymoon" period in newly diagnosed type 1 diabetics, and delays murine islet allograft rejection. the natural history of type 1 diabetes is unique for a phase frequently referred as the "honeymoon," a period in which the insulin need becomes minimal and glycemic control improves. the b cell (the insulin producing cell) partially recovers. however, as with all honeymoons, they end and the patient becomes completely insulin-deficient. the general consensus of the international diabetes community is to test potential preventive therapies for type 1 diabetes in newly diagnosed patients. prolongation of the honeymoon as the reversal of the disease is considered a positive result. in this phase ii randomized, double-blind, parallel-design clinical trial we will determine whether ingested (oral) human recombinant ifn-a will prolong the "honeymoon" period and increase counterregulatory anti-inflammatory cytokine(s). we will determine the safety and efficacy of 30,000 units ingested hrifn-a vs placebo in eighty patients with newly diagnosed type 1 diabetes in a phase ii trial for one year. primary outcome measures will be a 30% increase in c-peptide levels released after sustacal stimulation at 3, 6, 9, and 12 months after entry. secondary outcome will be decreasing titers of islet cell antibodies (ica). if successful, a larger and longer phase iii trial of prevention of type 1 diabetes in high risk patients will be undertaken. we will also determine if ingested hrifn-a increases il-4, il-10 or ifn-a production in peripheral blood mononuclear cells (pmnc) from patients with recent onset type 1 diabetes.


Eligibility criteria:
inclusion criteria: * newly diagnosed type 1 diabetes (within one month of diagnosis). * iddm patients: prepubescent, adolescent, or early adult patients. exclusion criteria: * patients below the age of 3 or over 25. * patients will not be eligible if they are on immunosuppressive or immunostimulatory medications such as azathioprine, oral nicotinamide, superoxide dismutase-desferroxamine, vitamin e, aminoguanidine, oral insulin or other experimental therapies at any time. * patients with a history of alcoholism, renal, cardiac, or pulmonary disease or in whom intellectual functioning is impaired sufficiently to interfere with the understanding of the protocol, or participation in the treatment and evaluation program * patients who are pregnant or nursing, or those who are not willing to practice an acceptable birth control method * patients with abnormal pre-treatment values on wbc or who are receiving potentially hepatotoxic medications
drug-drug interaction study of mitiglinide and gemfibrozil

Conditions: Type 2 Diabetes Mellitus

Summary: the primary objective of this study is to determine the extent of effect of gemfibrozil on the pharmacokinetics and pharmacodynamics of mitiglinide.


Eligibility criteria:
inclusion criteria: * non-smoker * body mass index (bmi) of 19-28 kg/m2 * no relevant food allergies exclusion criteria: * any subject for whom gemfibrozil is contraindicated * any subject with a history of hypoglycemia or who tend to get easily hypoglycemic * clinically significant history of or current abnormality or disease of any organ system
persistent postoperative pain after major emergency abdominal surgery

Conditions: Chronic Postoperative Pain

Summary: perioperative pain is one of the most significant complaints and problems for patients undergoing major open surgery. pain after surgery carry an abundance of consequences such as reduced mobilization, reduced nutrition intake, reduced pulmonary capacity and increased risk of complications and length of hospitalization. the literature does not supply much information on short- or longer-term outcomes of pain treatment for emergency surgery. the investigators know that for planned surgery in general around 10-50 percentage suffer from persistent postoperative pain. it is therefore important to follow-up on the longer-term outcomes after the standardized analgesic pain treatment. based on a predefined patient group called omega (optimizing major emergency abdominal surgery) the investigators hypothesize that omega patients will present a significant incidence rate of patients with persistent postoperative pain and/or continued opioid/non-opioid usage. therefore this study is to investigate the incidence of prolonged postoperative pain and opioid/non-opioid consumption in omega patients at 3 month after major emergency abdominal surgery.


Eligibility criteria:
inclusion criteria: * omega patients (patients who have undergone major emergency abdominal surgery including the stomach, small or large bowel, or rectum for conditions such as perforation, ischemia, abdominal abscess, bleeding or obstruction) * age 18 or more * surgery performed within 72 hours of an acute admission or as an acute re-operation exclusion criteria: * elective laparoscopy * diagnostic laparotomy/laparoscopy where no subsequent procedure is performed * non-elective hernia repair without bowel resection * admission or transfer to an intensive care unit
study testing ketamine sublingual wafer after wisdom tooth extraction

Conditions: Pain

Summary: the purpose of the study is to test two different doses of ketamine sub-lingual (under the tongue) wafer against placebo to see how effective the medication is to treat moderate to severe pain after wisdom tooth extraction.

this is a phase 2, randomized, double-blind, parallel group, dose-ranging placebo-controlled evaluation of the analgesic efficacy, safety and pharmacokinetics of ketamine sublingual wafer in adult subjects who experience post-operative pain after undergoing third molar extraction. the study will enroll approximately 80 subjects at a single site. subjects will be at least 18 years to 38 years of age. subjects will receive a single dose of 70 mg or 100 mg sublingual ketamine wafer or placebo. efficacy assessment will include pain intensity, use of rescue medication, and patient global assessment (pga) of pain control. safety assessments will include monitoring of aes and saes, clinical laboratory tests, vital sign measurements, oral assessments, and ecgs. a maximum of eight 4ml blood samples will be taken from each participant up to 8 hours after study drug administration for plasma analysis.

Eligibility criteria:
healthy male and female subjects, ages 18-38 years old, who are scheduled to undergo two ipsilateral third molar extractions.

Keywords: third molar extraction wisdom tooth extraction
healthy children, healthy families: parents making a difference

Conditions: Childhood Obesity Prevention

Summary: the impacts of healthy children, healthy families: parents making a difference! (hchf) on how low-income parents enrolled in the expanded food and nutrition education program use effective parenting practices to influence children's healthy eating and active play behavior will be investigated, as compared to a delayed intervention control group.

the healthy children, healthy families: parents making a difference! (hchf) curriculum is a cornell curriculum for parents and caregivers focusing on the behaviors most likely to help children avoid unhealthy weight gain. these behaviors include drinking water or milk instead of sweetened beverages, eating more vegetables and fruits, playing actively, eating fewer high-fat and high-sugar foods, limiting screen time, and having sensible serving sizes. the 8-session curriculum uses a learner-centered dialogue approach, hands-on activities and role plays. the study will include 300 participants with young children 3-5 years old in head start and childcare programs in new york city using a randomized control design. in period 1 (9 weeks), half the groups will receive hchf education (immediate education, ie) and half will serve as controls, receiving no education (delayed education, de). in period 2 (9 weeks), de will receive education; ie will receive no education and be followed longitudinally for periods 2 and 3. in period 3 (16 weeks), neither group will receive education and both will be followed longitudinally. data will be collected at each time point using validated measures, including the hchf checklist developed by the investigators and complementary measures that assess parenting feeding practices, food behavior in parents, food behavior in children, and parent self-efficacy around obesity prevention behaviors. it is hypothesized that change pre- to post- hchf will be greater than control groups, and changes in behavior will be retained post-education.

Eligibility criteria:
* inclusion criteria: parents/caregivers with young children 3-5 years old * exclusion criteria: any person who does not have children who are 3-5 years old

Keywords: childhood obesity parenting practices food and physical activity
tunisian registry of trans catheter aortic valve implantation

Conditions: Tunisian Patients Already Implanted With a TAVI

Summary: transcatheter aortic valve implantation (tavi) has emerged as a transformative therapy for patients with severe aortic stenosis, particularly those designated high-risk or inoperable for traditional surgical valve replacement. despite its increasing adoption worldwide, there re-mains a paucity of data regarding tavi outcomes in tunisian patients. in response to this gap in knowledge, the investigators propose the establishment of the tunisian tavi registry, a multicenter initiative aimed at comprehensively documenting the clinical characteristics, procedural de-tails, and short- and long-term outcomes of tavi procedures across tunisia. the tavi.tn registry will enroll consecutive patients undergoing tavi procedures at participating centers across tunisia, between 2013 and 2024 with a retrospective arm and a prospective arm. the tavi-tn registry represents a significant step towards enhancing our understanding of tavi outcomes in the tunisian population. by systematically capturing real-world data, this initiative aims to inform clinical decision-making, improve patient care, and contribute to the advancement of tavi practices in tunisia and beyond.


Eligibility criteria:
inclusion criteria: - any tunisian patient who was treated with tavi implantation in tunisia exclusion criteria: * patients who are not tunisians * patients not agreeing to sign consent, witnesses not agreeing to sign consent (family member)

Keywords: tavi death vascular complications pacemaker implantation echocardiography
sudden death stratification

Conditions: Non-ischemic Cardiomyopathy

Summary: sudden cardiac death (scd) risk stratification is a challenge in non-ischemic cardiomyopathy (nicm). the underlying mechanism of monomorphic ventricular tachycardia (vt) is mostly scar related. while electrophysiological mechanisms underlying ventricular arrhythmia are well known, late gadolinium enhanced (lge) cardiac mri-3d reconstructions are now able to guide vt ablation procedures. such exam may help in identifying specific properties of scar at risk of malignant arrhythmia.


Eligibility criteria:
inclusion criteria: * adult with nicm * previous history of ventricular tachycardia (vt) and no previous history of vt exclusion criteria: * inherited cardiomyopathies * previous history of myocarditis without oedema/scar at the mri

Keywords: lge mri ventricular tachycardia sudden cardiac death non-ischemic cardiomyopathy
prospective open label clinical trial to administer a booster dose of pfizer/biontech or moderna covid-19 vaccine in high-risk individuals

Conditions: SARS CoV 2 Infection; COVID-19

Summary: the recent rise in infections with the omicron variant of the sars-cov-2 is alarming. equally disconcerting is the fact that individuals who were previously vaccinated (\< 6 months) and have co-morbidities that are considered high risk, are getting re-infected...a process referred to as "breakthrough". there is some evidence that in these high risk individuals, the gradual decrease in immunity against the virus as depicted by a drop in anti-sars-cov-2 antibodies, is responsible (partially or wholly) for this reinfection. in this study, we intend to give a booster does pfizer/biontech and/or moderna and ascertain the levels of antibodies at various times pre and post vaccination. the incidence of infection with sars-cov-2 after booster vaccination will also be obtained.


Eligibility criteria:
inclusion criteria: * adults 18 years and over that have been fully vaccinated (2 doses) with the pfizer/biontech covid-19 vaccine (bnt162b2) and with the 1st booster at least 90 days prior to the 2nd booster * healthcare workers employed by and/or affiliated with dhr health, renaissance medical foundation, dhr partners, starr county memorial hospital * any adult with any of the following risk factors for severe covid-19 disease progression (as outlined by the cdc) exclusion criteria: * previous history of allergic reaction to vaccination * less than or equal to 3 months from last booster dose of vaccine * active sars-cov-2 infection * less than or equal to 21 days of full recovery from sars-cov-2 infection * less than or equal to 14 days of any vaccination * vaccinated with any other available covid-19 vaccine other than pfizer/biontech or moderna * healthcare workers not employed by and/or affiliated with dhr health, renaissance medical foundation, star county memorial hospital or non dhr partners