Kornimate/medical-research-clean huggingface dataset:
the effect of melatonin supplementation on cumulus cells and ivf outcomes

Conditions: Unrecognized Condition

Summary: this study investigates the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (ivf) outcomes in women over 35 years old. in the study group, patients will receive melatonin supplementation for at least two months prior to their ivf cycles. cumulus cells will be collected after oocyte retrieval, and ivf outcomes will be assessed.

aging in female reproductive cells, particularly cumulus granulosa cells, is associated with various dysfunctions that compromise fertility. melatonin, a hormone primarily produced by the pineal gland, is renowned for its multifaceted roles in regulating physiological processes, including sleep-wake cycles, immune function, and antioxidative defense. melatonin's antioxidant action is mediated through direct scavenging of free radicals, upregulation of antioxidant enzymes, and improvement of mitochondrial efficiency. these properties make melatonin a promising candidate for mitigating the adverse effects of aging on cellular function. this study aims to explore the effects of melatonin supplementation on cumulus cell gene expression and in vitro fertilization (ivf) outcomes in women over 35 years old. in the study group, patients will receive melatonin supplementation for at least two months prior to their ivf cycles. in the control group, patients will proceed directly to ivf cycles without melatonin supplementation. cumulus cells will be collected after oocyte retrieval, and gene expression will be measured. additionally, clinical pregnancy rate, live birth rate, and miscarriage rate between the two groups will be evaluated.

Eligibility criteria:
inclusion criteria: * age 35-45 years * bmi 18-30 kg/m2 * planning to undergo ivf cycles exclusion criteria: * primary ovarian insufficiency * history of oophorectomy * receiving oocyte donation * chromosome anomaly * congenital uterine anomaly * severe intrauterine adhesion * malignancy * using hormone therapy or supplements in recent 3 months

Keywords: melatonin cumulus cells in vitro fertilization old women infertility
open label study to assess safety, pk and explore efficacy of oprx-106 in patients with active mild to moderate ulcerative colitis

Conditions: Ulcerative Colitis

Summary: this is a proof of concept, randomized, open label, 2-arm study of oprx-106 in subjects with active mild to moderate ulcerative colitis. eligible subjects will be enrolled and randomized to receive 2 mg or 8 mg of oprx-106 administered orally, once daily for 8 weeks.


Eligibility criteria:
main inclusion criteria: 1. have had a diagnosis of ulcerative colitis for a minimum of 3 months 2. have active mild to moderate ulcerative colitis, as defined by a full mayo score at screening 3. have adequate cardiac, renal and hepatic functions as determined by the investigator and demonstrated by screening clinical and laboratory evaluations, and physical examination results 4. high level of calprotectin (\>100 mg/kg of stool) main exclusion criteria: 1. have a history of colonic or rectal surgery other than hemorrhoidal surgery or appendectomy 2. .positive for active/ latent mycobacterium tuberculosis (tb) infection 3. .have a history of infection requiring administration of any iv antibiotic, antiviral or antifungal medication or any oral anti-infective agent 4. severe ulcerative colitis 5. ulcerative proctitis, defined as disease limited to less than 15 cm from the anal verge 6. use \>4.8 g 5-asa or equivalent 7. use of corticosteroid or 5-asa enemas, foams, or suppositories 8. use of anti-inflammatory medications or natural remedies 9. use oral or parenteral antibiotics 10. use of chronic non-steroidal anti-inflammatory (nsaid) therapy 11. use of immune suppressive agents including anti-tnf agents, azathioprine, 6mp, methotrexate 12. use of steroids 13. have a diagnosis of: crohn's disease; indeterminate colitis; microscopic colitis; ischemic or infectious colitis; clostridium difficile colitis, parasitic disease
periodontal disease and preterm birth

Conditions: Periodontal Disease; Preterm Birth; Low Birth Weight

Summary: to determine the relationship between periodontal disease and upper genital tract inflammation in pregnancy. to determine whether certain fluid levels in the oral cavity and the vagina are associated with preterm birth or low-birth weight.

patients will be enrolled in the study at their first prenatal visit after the details of the study have been discussed. potential subjects will be presented with a questionnaire to determine eligibility for the study. the patient will be scheduled for an exam between 18-24 weeks at which time they will undergo a periodontal assessment, to determine the presence or absence of periodontal disease, a sampling of gingival crevicular fluid (gcf) and a vaginal swab collection. periodontal disease will be determined by measuring the depth of gingival sulci, amount of periodontal attachment loss, and prevalence of gingival bleeding at six sites for each tooth present.

Eligibility criteria:
inclusion criteria: * between the ages of 15-35 * singleton gestation exclusion criteria: * diabetes prior to pregnancy * require antibiotic prophylaxis prior to dental treatment * require steroids during pregnancy

Keywords: periodontal disease preterm birth low birth weight pregnancy
biomarkers in predicting treatment response in samples from patients with early-stage non-small cell lung cancer previously treated with adjuvant chemotherapy

Conditions: Stage IA Non-small Cell Lung Cancer; Stage IB Non-small Cell Lung Cancer; Stage IIA Non-small Cell Lung Cancer; Stage IIB Non-small Cell Lung Cancer; Stage IIIA Non-small Cell Lung Cancer

Summary: this research trial studies biomarkers in predicting treatment response in samples from patients with early-stage non-small cell lung cancer previously treated with adjuvant chemotherapy. studying samples of tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict how patients will respond to treatment.

objectives: i. validation of the 15-gene prognostic and predictive messenger (m) ribonucleic acid (rna) signature on lung adjuvant cisplatin evaluation (lace)-bio formalin-fixed, paraffin-embedded tissue (ffpe) tumor samples. ii. exploratory evaluation of the prognostic and predictive values of known potential oncogenic mutations using lace-bio ffpe tumor samples. iii. exploratory evaluation of the prognostic and predictive values of gene copy variations using lace-bio ffpe tumor samples. iv. exploratory identification and evaluation of prognostic and predictive value of novel genomic aberrations discovered by next generation sequencing on lace-bio tumor samples. outline: archived rna and dna samples are analyzed for gene expression, mutations, and variations by reverse transcriptase (rt)-polymerase chain reaction (qpcr), mass spectrometry (massarray), molecular inversion probe assay, and microarray assays. results are then compared with patients' clinical outcomes.

Eligibility criteria:
inclusion criteria: * samples from patients treated in 4 adjuvant chemotherapy (act) for early-stage non-small cell lung cancer (nsclc) pivotal trials: * international adjuvant lung cancer trail (ialt) * cancer and leukemia group b (calgb)-9633 * can-ncic-br10 * adjuvant navelbine international trialist association (anita) * not specified * see disease characteristics
postoperative belladonna and morphine suppositories in vaginal surgery

Conditions: Vaginal Surgery

Summary: our primary aim is to determine whether the routine use of belladonna and morphine suppositories will improve pain control following vaginal surgery. treatment will begin immediately following surgery and every 8 hours for 16 hours.

minimizing postoperative pain is vital to a successful surgical recovery. inadequate pain control may result in nausea, vomiting, an extended hospital stay, and reduced patient satisfaction. oral and parenteral narcotics are commonly used for pain relief and their use may exacerbate the incidence of sedation, nausea, and vomiting; ultimately delaying convalescence. previous studies have demonstrated that rectal analgesia following surgery results in lower pain scores and less intravenous morphine consumption. belladonna and opium suppositories are routinely prescribed at our institution and their efficacy has not been confirmed. a prospective, randomized, double-blind, placebo-controlled trial will be undertaken using belladonna and opium rectal suppositories following vaginal surgery. treatment will begin immediately following surgery and continue every 8 hours for a total of 3 doses.

Eligibility criteria:
inclusion criteria: * scheduled for elective vaginal surgery requiring general anesthesia at the mayo clinic hospital. this would include a vaginal hysterectomy with culdoplasty or post-hysterectomy prolapse repair, including culdoplasty with or without anterior/posterior repair. exclusion criteria: * participation in another trial using an investigational product. * pregnancy. * scheduled for a non-vaginal surgical procedure. * scheduled for a robotic hysterectomy. * scheduled to have combined surgeries (vaginal surgery plus another non-vaginal surgery). * there is a known hypersensitivity to belladonna and/or opium. * contraindication to narcotic use. * chronic pain with preoperative pain score greater than 4 out of 10 points. * clinically significant substance abuse. * mental condition that may impair the ability to provide study assessments.

Keywords: belladonna morphine suppositories vaginal surgery postoperative pain
preventive treatment of vetd in patients with multiple myeloma receiving chemotherapy with thalidomide or lenalinomide.

Conditions: Multiple Myeloma

Summary: patients with multiple myeloma have seen their survival rate strongly improved with the use of new anti angiogenic agents. among them, the new chemotherapy with thalidomide or lenalinomide are frequently successfully suggested in therapeutic protocol such as mpt however they can strongly increase the risk of venous thrombo embolic disease (dvt and pte) up to 20%. in these conditions, a prevention of this risk can be proposed by physician with either low molecular weight heparin (lmwh) anticoagulants or antiplatelets agents. pending the new recommendations on the management of vted, the purpose of this study is to describe in real life conditions the management by oncologists of the thrombo embolic risk for such patients


Eligibility criteria:
inclusion criteria: * patients with multiple myeloma receiving a chemotherapy protocol including thalidomide or lenalidomide exclusion criteria: * patients involved in an interventional clinical trial
ruxolitinib in combination with autotransplant

Conditions: Myelofibrosis; MF

Summary: to determine the safety of the approach of giving ruxolitinib before and after an autologous stem cell transplant, as measured by graft failure or death.

this is a pilot, single arm, single center study with no stratification to assess the safety (measured by graft failure or death) and feasibility (measured by adequacy of stem cell collection) of combining ruxolitinib with autologous hematopoeitic stem cell transplantation (hsct) in patients with advanced myelofibrosis (mf). patients will receive a short course of ruxolitinib prior to and during mobilization of hsct with filgrastim. conditioning for the autologous hsct will consist of bulsulfan. post-transplant patients will receive ruxolitinib maintenance.

Eligibility criteria:
inclusion criteria: * histologically documented diagnosis of mf (idiopathic or post pv/et) * age 18-75 years * intermediate-2/ high-risk disease as per dynamic ipss (dipss) criteria or intermediate-1 risk disease with one of the following features within one year from screening: 1. red cell transfusion dependency 2. unfavorable karyotype 3. platelet count \<100 x 109/l 4. symptomatic splenomegaly 5. pb blasts \> 1% 6. blasts in pb \<20% prior to study enrollment 7. no available suitable matched related (6/6 or 5/6) or unrelated donor (8/8 or 7/8 allele matched) or unwilling or unable to pursue allogeneic stem cell transplant 8. wbc \<50,000/ml at screening * able to give informed written consent * ecog performance status of 0-2 * life expectancy \>6 months * off all myelofibrosis-related investigational or standard agents (except for ruxolitinib) for at least 4 weeks prior to study enrollment and recovered from all toxicities. if patient is already on ruxolitinib for a minimum of 16 weeks prior to study enrollment, patient can proceed to mobilization and collection * adequate organ function defined as the following (\*unless clearly disease related): 1. adequate renal function - creatinine \<2 x uln 2. adequate hepatic function - ast/alt \<3 x uln, total bilirubin \<3 x uln, exception is elevated indirect bilirubin attributed to gilbert's syndrome or hemolysis 3. adequate hematopoietic function - platelet ≥50 x 109/l (without transfusion) and anc ≥1.0 x 109/l 4. lvef \>40% (muga or echocardiogram) 5. adequate pulmonary function with dlco \>40% exclusion criteria: * hypersensitivity to jak inhibitor * clinical evidence of cirrhosis * leukemic transformation (\>20% blasts in pb or bm any time prior to hct) * platelet count \<50 x 109/l * active uncontrolled infection * history of another malignancy within 5-years of date of hct except history of basal cell or squamous cell carcinoma of skin or pv or et * known hiv positive * woman of childbearing potential unwilling or unable to use adequate contraception pregnant or nursing females known active infection with hepatitis a, b or c virus

Keywords: myelofibrosis ruxolitinib autologous stem cell transplant
nitazoxanide in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: ulcerative colitis (uc) is a chronic inflammatory bowel disease (ibd) that primarily affects the rectum and colon. the severity and persistence of mucosal inflammation are associated with morbidity and mortality.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * both male and female will be included * mild and moderate uc patients are already diagnosed and confirmed by endoscope and histopathology. exclusion criteria: * breast feeding or pregnancy. * colorectal cancer patients. * patients with severe uc. * patients taking rectal or systemic steroids. * patients taking immunosuppressives or biological therapies. * addiction to alcohol and / or drugs. * known allergy to the studied medications.
serial evaluation of multiple coronary artery diseases by an optical coherence tomography; assessment of the changes of de novo lesions and comparisons of neointimal coverage between xience prime® versus cypher selecttm stents; seven-xience study

Conditions: Multi-vessel Diseases, Angina

Summary: this study is a prospective open-labeled, randomized study to compare the neointimal coverage at 3 months and 12 months and its serial changes between 3 months and 12 months according to the implanted des and evaluate the serial changes in the proximal portions of 3 epicardial coronary artery and left main artery including the assessment of fibrous cap thickness and lipid pool for vulnerable plaques by oct. in addition, the investigators will compare the changes such as plaques and neointimal coverage from serial oct follow-up according to the different statin strategy.


Eligibility criteria:
inclusion criteria: * patient is ≥ 20 years old * patients with typical angina who are considered for coronary revascularization. * multi-vessel diseases: more than 2 significant coronary de novo lesions (\> 70% by quantitative angiographic analysis); one of the target lesions is the most significant tight stenotic lesion causing the ischemic symptom and requiring the immediate revascularization but the others are significant but non-tight lesions to be delayed or observed for 3 months and not requiring immediate pci for the complete revascularization of all coronary arteries. exclusion criteria: * st-elevation mi * cardiogenic shock or hemodynamically unstable status * lesions requiring the immediate complete revascularization of all coronary stenotic lesions * contraindication to anti-platelet agents * treated with any des within 6 months at other vessel * creatinine level ≥ 2.0 mg/dl or esrd * severe hepatic dysfunction (3 times normal reference values) * pregnant women or women with potential childbearing * life expectancy 1 year * complex lesion morphologies (bifurcation lesions treated with 2-stent techniques, untreated significant unprotected left main diseases, chronic total occlusion, in-stent restenosis, and vein graft lesion)
the effect of emotional freedom technique and virtual reality glasses on anxiety and vital signs

Conditions: Anxiety

Summary: the aim of the study was to examine the effects of the emotional freedom technique and virtual reality glasses applied to individuals receiving hyperbaric oxygen therapy for the first time on anxiety and vital signs. the hypotheses of this research are that there is a difference between the emotional liberation technique and virtual reality glasses groups and the control group in terms of anxiety and vital signs.

this study was designed as a pretest-posttest regular parallel group, randomized controlled experimental. the research will be carried out in konya city hospital hyperbaric oxygen therapy unit. patients will be randomly assigned to three groups: emotional freedom technique group (25), virtual reality glasses group (25) and control group (25). for emotional freedom technique group: the emotional freedom technique will be applied by the researcher who has received the practitioner training certificate. for virtual reality glasses group: the video containing the nature walk will be watched by virtual reality. for the control group: no intervention will be made in the control group. standard care will be given. the primary result of this study is to determine the patients' anxiety scores. secondary results of the research are to determine the patients' vital signs.

Eligibility criteria:
i̇nclusion criteria * applying hbo treatment for the first time, * volunteering to participate in the research, * those who are between the ages of 18 and 65, * able to speak and understand turkish (patients who will not have communication problems), * without a psychiatric diagnosis, * those who have not received training on coping with anxiety and fear before, * those who have not attended a course on energy therapy before, * vital signs are within normal limits exclusion criteria: * having hearing and vision problems, * urgently placed on hbo treatment, * patients without chronic diseases, * patients with impaired tissue integrity at eft energy points
meshed vein graft patency trial - vest

Conditions: Coronary Artery Disease

Summary: the study hypothesis is that a meshed conduit made of safen vein allows a better patency at mid-long term than a safen vein alone. to test this hypothesis the investigators plan a prospective, randomized study, comparing grafts to the diagonal, in cases of vessel diameter under 1.5mm. a control angiography will be performed one year after the operation.


Eligibility criteria:
inclusion criteria: * clinical indication for elective coronary artery bypass grafting with at least one vein graft * coronary artery with critical stenosis (over 70%) exclusion criteria: -

Keywords: mesh graft patency
dna damage and subfertility in males - lifestyle interventions to improve male fertility and health

Conditions: Infertility

Summary: a lifestyle intervention study in infertile males of couples seeking fertility treatment with a dna fragmentation index (dfi) above 15 percentage. a reduction in dna fragmentation index of 10 percentage points is expected after 3-4 months of intervention.


Eligibility criteria:
inclusion criteria: * dna fragmentation index above 15 % exclusion criteria: * tesa/pesa

Keywords: male infertility dna fragmentation index dfi life style intervention
lifestyle intervention for healthy change

Conditions: Overweight and Obesity

Summary: the purpose of this study is to determine the effectiveness of a physician led, multi-disciplinary approach to treating obesity that incorporates nutrition (mainly, using genetics to identify appropriate food intake), exercise, and motivational counseling. the investigators plan to recruit overweight/obese (bmi\>25) males and females to participate. participants will be randomized to receive a personalized diet plan, or a standard care diet plan; both groups will participate in the exercise intervention. for a 6-month duration, both groups will be asked to improve their diet according to their dietary plan and participate in moderate-to-vigorous physical activity (gradual increase up to 300 min/week). the investigators intend to evaluate standard outcomes of weight loss, and assess for any predictors of positive outcomes. following the six-month intervention, participants will complete a 3-month no contact phase. this no contact phase will provide insight into the effects of the study on weight loss maintenance. our team also plans to address acceptability by providing evaluations to study participants and conducting interviews with a small subset of participants to improve the intervention for the future.


Eligibility criteria:
inclusion criteria: * age 18-40 years * bmi \> 25 kg/m2 * no cardiopulmonary disease * stable on medications for 3 months * weight stable (+/-5 pounds) for the past 3 months * not pregnant or trying to get pregnant * owns a smartphone * able to walk unassisted * not on supplemental oxygen exclusion criteria: * under the age of 18 years * 40 years and older * unable to participate in an exercise program * currently pregnant

Keywords: physical activity dietary intervention