Kornimate/medical-research-clean huggingface dataset:
hope trial hcg or progesterone effect on recurrent pregnancy loss

Conditions: Recurrent Pregnancy Loss Without Current Pregnancy

Summary: up to half of all cases of recurrent pregnancy loss are unexplained (urpl). evidence points towards endometriosis and progesterone resistance as an underlying cause of urpl. previous non-rct studies have suggested the luteal hcg provides a useful treatment for urpl. we propose performing a randomized controlled trial to compare mid-luteal hcg with oral progesterone to prevent early pregnancy losses. the endpoint will be ongoing pregnancy and live birth rates. equal numbers of patients will be randomized to each group.

fifty (50) patients with unexplained recurrent pregnancy loss, defined as 2 or more losses. workup will exclude structural, genetic, hormonal, and anti-phospholipid syndrome-related causes of rpl. women with unexplained rpl will be randomized to receive a mid-luteal injection of ovidril (250 ug) 1 week after ovulation vs prometrium (200 mg qhs) starting 4 days after ovulation. if pregnant, prometrium will be continued until 8 weeks of pregnancy. if pregnancy does not occur, subjects will be allowed to repeat this protocol for up to 3 cycles. outcomes will be listed as "not pregnant", "biochemical pregnancy", "miscarriage" or "ongoing pregnancy" for each cycle. endpoints of pregnant cycles will be compared for pregnancy rate, miscarriage rate, ongoing pregnancy rate and live birth rate.

Eligibility criteria:
inclusion criteria: * 2 first trimester losses * unexplained recurrent pregnancy loss exclusion criteria: * antiphospholipid syndrome * uterine septum * asherman's syndrome * paternal or maternal genetic abnormalities (i.e. balanced translocation) * endocrine causes of rpl (thyroid, diabetes, hyperprolactinemia)
long-term safety of ospemifene 60 mg oral daily dose for the treatment of vulvar and vaginal atrophy (vva) in postmenopausal women without a uterus

Conditions: Atrophy; Vaginal Diseases

Summary: the objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (vva) in postmenopausal women without a uterus.


Eligibility criteria:
inclusion criteria: * postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (vva) as assessed by vaginal ph, maturation index of vaginal smear, and self-reported symptoms at baseline for protocol 15-50310 * did not have a uterus * met the inclusion and exclusion criteria for protocol 15-50310 * had completed protocol 15-50310 without any clinically significant abnormal findings at the end-of-study visit for protocol 15-50310 * provided written informed consent to participate in the study and agreed to follow dosing instructions and complete all required study visits exclusion criteria: * had clinically significant abnormal findings at the week 12 end of study visit for protocol 15-50310 * had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures

Keywords: menopausal symptoms vulvar and vaginal atrophy in menopausal women vaginal atrophy urogenital atrophy
study to develop head stabilizer for use during brain radiation therapy

Conditions: Brain Diseases; Brain Cancer

Summary: the purpose of this study is to begin to develop a device to stabilize the head during stereotactic radiosurgery (srs). srs is a therapy for brain disorders and cancers that uses a precise dose of radiation to treat a disease, and is different from whole brain radiation. this study aims to stabilize patient head motions during radiation therapy through the use of a special experimental head holder. the investigators would like to first see how the experimental device works in whole brain radiation.


Eligibility criteria:
adults undergoing whole brain radiation cancer treatment at the university of chicago medicine.
evaluating an online acceptance and commitment training program for individuals with chronic health conditions

Conditions: Stress, Psychological; Depression; Well-Being, Psychological

Summary: chronic health conditions (chc) commonly share the challenge of impaired health-related quality of life, negatively impacting the lives of millions of people in the united states. long term effects for living with a chronic health condition are likely to include poor self-management behaviors, which are related to avoidance of disease related thoughts and feelings (e.g., health anxiety) and can be addressed directly with psychosocial interventions. with the focus on fostering values driven and meaningful behavior while accepting thoughts and feelings, act may prove to be a particularly effective approach for individuals coping with the challenging symptoms and effects of having a chronic health condition. previous web-based act interventions for chcs have focused on building act skills for a narrow subset of chcs (e.g., breast cancer, diabetes, tinnitus). while there is added benefit for a self-help program for populations with specific stressors or conditions, there is also a high prevalence of comorbidity in chcs, shared challenges in illness management and coping, and clear evidence that act works effectively across chcs to improve quality of life. thus, our goal of this research project is to evaluate a new 6 session, online, self-guided act program for adults with chronic health conditions broadly to improve their quality of life and wellbeing through a randomized controlled trial. the specific aims are: 1. to evaluate the feasibility of an initial prototype of act program for adults with chc's as indicated by recruitment, retention, and adherence rates. 2. to evaluate the acceptability as indicated by self-reported program satisfaction and qualitative feedback following the course completion. 3. to identify ways to further refine the program based on participant self-reported satisfaction with sessions and open-ended text-based feedback. 4. to test the efficacy of the program on improving quality of life among adults with chc's.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old * currently living in the u.s. * self-report having at least 1 chronic health condition (e.g., cardiovascular disease, cancer, diabetes, chronic pain, rheumatoid arthritis, hiv, parkinson's disease, irritable bowel syndrome, crohn's disease, chronic obstructive pulmonary disease, multiple sclerosis) * self-report having had the chronic health condition for ≥ 3 months * can access the internet via computer, mobile phone, or tablet * have an interest in using an online mental health intervention exclusion criteria: • not fluent in reading english (at this point the online program can only be feasibly and competently delivered in english)

Keywords: acceptance and commitment therapy chronic health conditions
cannabidiol oral solution as an adjunctive treatment for treatment-resistant seizure disorder

Conditions: Seizures

Summary: this is a multicenter, open-label trial to assess the long-term safety and efficacy of cannabidiol oral solution as adjunctive therapy for pediatric participants with treatment-resistant seizure disorders, including lennox-gastaut syndrome (lgs) or dravet syndrome (ds). all participants have rolled over from previous trials: ins011-14-029 (nct02324673) and ins011-15-054 (nct02551731).


Eligibility criteria:
inclusion criteria: * completed activities through day 11 in ins011-14-029 or part a (visit 6) ins011-15-054 * informed consent/assent (as applicable) was voluntarily provided by the participant and/or parent(s)/caregiver(s) in accordance with applicable laws, regulations, and local requirements * is medically stable with no anticipated changes in chronic medications in the opinion of the investigator * continues to meet protocol-specified criteria for qualification and contraception, including treatment-resistant seizure disorder * in the opinion of the investigator, the subject and/or parent(s)/caregiver(s) are able to continue keeping accurate seizure diaries exclusion criteria: * inadequate supervision by parent(s)/caregiver(s) * history or current use of dietary supplements, drugs or over-the counter medications outside protocol-specified parameters * signs, symptoms or history of any condition that, per protocol or in the opinion of the investigator, might compromise: 1. the safety or well-being of the participant or study staff 2. the safety or well-being of the participant's offspring (such as through pregnancy or breast-feeding) 3. the analysis of results

Keywords: lennox-gastaut syndrome dravet syndrome treatment-resistant seizures
effectiveness, safety and feasibility of auxiliary nurse midwives' (anm) use of oxytocin in uniject™ to prevent postpartum hemorrhage in india

Conditions: Postpartum Hemorrhage

Summary: this cluster randomized community-based trial is designed to test the hypothesis that the intramuscular administration of 10 iu of oxytocin in uniject™ during the third stage of labor by an auxiliary nurse midwife (anm) at births occurring in homes, sub-centers and primary health centers in bagalkot, india will reduce the risk of postpartum hemorrhage by 44% (from 9% to 5%) relative to home births attended by the same type of provider who does not provide the intervention drug. the study will also document correct use of oxytocin in uniject, adverse maternal and fetal events associated with inappropriate use and a number of indicators reflecting the programmatic feasibility of implementing this intervention.


Eligibility criteria:
inclusion criteria: * gestational age \>=28 wks at enrollment * anticipate spontaneous vaginal delivery * hemoglobin \>=8 gm/dl * delivery at home, sub-center, or primary health center * delivery attended by auxilliary nurse midwife exclusion criteria: * previous caesarean-section * scheduled for caesarean-section * antepartum bleeding during current pregnancy * blood pressure \>140mm of hg systolic and \>90mm of hg diastolic * in active labor at time of recruitment * high risk medical conditions (diabetes, cardiac ailments, seizures, placenta previa, anticipated breech delivery

Keywords: uterotonic oxytocin randomized trial india community hemorrhage
prediction of opioid-induced respiratory depression in patients monitored by capnography

Conditions: Respiratory Depression

Summary: prodigy is a prospective, multi-center, post-market, international cohort study. the primary objective of this study is to derive a score to identify subjects at risk to have respiratory depression (rd) episodes in patients undergoing opioid therapy in the hospital ward and monitored by capnography. the score will be derived by using subjects within the derivation cohort and internally validated using subjects within the validation cohort. the primary endpoint used to derive the score will be the occurrence of rd episodes derived by capnostream 20p device memory data combined with clinical data and validated by an independent clinical endpoint committee (cec) during the study course.


Eligibility criteria:
inclusion criteria: 1. patients receiving parenteral opioid therapy (for post-surgical or non-surgical) pain on the hospital ward. 2. adult age (≥18 year old in us and europe; ≥20 years old in japan; ≥21 years old in singapore). 3. patient is able and willing to give informed consent. exclusion criteria: 1. expected length of stay ≤ 24 hours. 2. patient is receiving intrathecal opioids. 3. post-surgical patients with american society of anesthesiologists physical status (asa ps) v or higher. 4. patients with the status of do not resuscitate (dnr), hospice, or receiving end of life therapy. 5. ventilated or intubated patients. 6. patient is unwilling or unable to comply fully with study procedures (including non-toleration of the capnography cannula) due to any disease condition which can raise doubt about compliance and influencing the study outcome. 7. patient is a member of a vulnerable population, including legal incapacity or evidence that a subject cannot understand the purpose and risks of the study, regardless of authorized representative support. 8. patient is participating in another potentially confounding drug or device clinical study.
a phase ii, randomized, cross-over, vehicle-controlled, double-blind, multicenter study of the safety, pharmacodynamics, and preliminary efficacy of ghrp-1/ag in subjects with esrd on hemodialysis

Conditions: End Stage Renal Disease

Summary: malnutrition and altered protein catabolism are serious problems in renal failure and hemodialysis (hd) patients. the purpose of this study is to characterize the safety of ghrp-1/ag in subjects with esrd on hd; to characterize the pharmacodynamics (pd) of ghrp-1/ag in subjects with esrd on hd by following gh and igf-1; to describe the relationship between ghrp-1 pd and plasma concentrations of ghrp-1 and des-ala-ghrp-1; and to evaluate the preliminary efficacy of ghrp-1/ag on nutritional status of subjects with esrd on hd using subjective global assessment of malnutrition inflammation scores (mis) and changes in caloric intake.

this is a randomized, cross-over, double-blind, vehicle-controlled study. subjects will receive single subcutaneous injections of the active ghrp-1/ag study treatment and vehicle control (atrigel delivery system) in a randomized sequence. each injection will be followed by a 4-week period of treatment exposure and a 2-week period of washout/follow-up. treatments will be administered on the 2nd dialysis day of a 3x/week dialysis schedule. the total duration of study participation will be 12 weeks. safety will be followed throughtout the study with vital signs, electrocardiogram, clinical chemistry and hematology parameters, endocrine parameters, adverse events, and concomitant medications. pd effects of ghrp-1/ag will be evaluated by measuring gh, icf-1, igf-bp3, prolactin, and cortisol. efficacy will be evaluated throughout the study with mis, caloric intake, npcr, dry weight, bmi, and albumin, bun, creatinine, calcium, potassium, hgb, hct, and cbc.

Eligibility criteria:
inclusion criteria: * subjects with esrd who have been on hd for at least 3 months and have a urea reduction rate (urr) of at least 65%. * subjects who are 18 to 70 years of age. * subjects who have a body mass index (bmi) less than 30, albumin greater than 3.3 g/dl, and mis of 5 to 10 (inclusive). exclusion criteria: * subjects who have diabetes and are currently taking insulin. * subjects who have a history of or current significant central nervous system (cns) disorders. * subjects who have active infection at baseline. * subjects who have active or unstable cardiac or arterial disease. * subjects who have uncontrolled tertiary hyperparathyroid condition. * subjects who have anemia. * subjects who have a history of hepatitis or current liver disease.

Keywords: end stage renal disease hemodialysis malnutrition end stage renal disease (esrd)
pilot study on deep learning in the eye

Conditions: Central Serous Chorioretinopathy; Diabetic Retinopathy; Cataract

Summary: deep learning allows you to classify images using a self-learning algorithm. transfer learning builds on an existing self-learning algorithm to enable image classification with fewer images. in this study, this technique will be applied to different image modalities in different syndromes. retrospective study design.


Eligibility criteria:
inclusion criteria: * availability of images, which allow discrimination. exclusion criteria: * no availability of clear data on disease differentiation
prediction of ua/sod ratio as a biomarker of oxidative stress in atrial fibrillation

Conditions: Atrial Fibrillation; Hyperuricemia

Summary: to clarify the predictive effects of uric acid and superoxide dismutase as biomarkers of oxidative stress on atrial fibrillation, and to provide greater value for the diagnosis and prediction of atrial fibrillation. it provides a new idea for the prevention and treatment of atrial fibrillation.

in recent years, a growing number of reports have shown the importance of oxidative stress in the pathophysiological mechanism of af. during oxidative stress, there is an imbalance between the production of pro-oxidant reactive species and the antioxidant defenses of the cell, and excessive oxidation leads to oxidative damage and cell death. redox processes can lead to atrial fibrosis and cardiac remodeling , suggesting that strategies to address myocardial oxidative stress may constitute a reasonable approach for the treatment of af. however, few studies have reported the relationship between comprehensive oxidative stress-related biomarkers and af. the purpose of this study was to illuminate the relationship of several blood markers of oxidative stress with af and to provide new clues for the prevention and treatment of af.

Eligibility criteria:
inclusion criteria: this retrospective study enrolled all hospitalized patients from january 2018 to december 2020 at the department of cardiology in the first affiliated hospital of shandong first medical university. the diagnosis of af was based on 12-lead electrocardiography (ecg) or 24-hour holter monitoring, and classification was based on the published 2020 esc guidelines for the diagnosis and management of af. exclusion criteria: 1. acute heart failure and acute myocardial infarction; 2. severe liver or kidney dysfunction (with aspartate aminotransferase or alanine aminotransferase levels three times higher than normal and estimated glomerular filtration rate \<30 ml/ (min\*1.73 m2)); 3. malignant tumors; 4. missing data of laboratory indicators at baseline.

Keywords: hyperuricemia atrial fibrillation
family routines - healthy families

Conditions: Diabetes Mellitus, Type 1

Summary: the purpose of the proposed study, family routines - healthy families, is to examine the feasibility and acceptability of a parenting/family routine intervention program for parents of young children, ages 2-5, with type 1 diabetes.

the intervention in family routines - healthy families contains an established and effective parent skills training curriculum called "the incredible years," uniquely integrated with a newly developed family evening routine component e.g., family dinner time and evening routine, to promote improved metabolic control. the investigator will assess outcomes during and at one week post intervention. outcome measures will include family routine, specifically the time between the dinner and bedtime glucose check, parent bedtime decision making, and child overnight glucose control. in addition, parental quality of life and receptiveness to the intervention will be assessed.

Eligibility criteria:
inclusion criteria: 1. self identification as primary care giver of child that fits following criteria: 1. age 2 - 5 years 2. diagnosis of type 1 diabetes 3. most recent hemoglobin a1c (hba1c) \> 8.0 4. child a patient of pediatric endocrinology, beaumont children's hospital 2. english fluency exclusion criteria: 1. cognitively impaired 2. does not meet inclusion criteria

Keywords: diabetes
butterfly pea flower (clitoria ternatea) for adjuvant tb treatment

Conditions: Tuberculosis (TB); Tuberculosis Treatment Effectiveness

Summary: the goal of this clinical trial is to learn if butterfly pea flowers (clitoria ternatea) decocta extract works to treat as adjuvant therapy for tuberculosis in adults. it will also learn about the safety of butterfly pea flowers decocta extract. the main questions it aims to answer are: * does butterfly pea flower extract as an adjunct tb drug therapy drug affect the profiles of interferon gamma and interleukin-10 of people with tuberculosis? * does butterfly pea flower extract as an adjunct tb drug therapy drug affect the hematology profiles of people with tuberculosis? * does butterfly pea flower extract as an adjunct tb drug therapy drug affect the clinical symptoms and acid-fast bacilli microscopic analysis of people with tuberculosis? * what medical problems do participants have when taking butterfly pea flower decocta extracts? researchers will compare butterfly pea flower extract as an adjunct tb drug therapy to monotherapy tb drugs to see if adjuvant butterfly pea flowers extract works to treat tuberculosis infection in 2-month initiation phase therapy. participants will: * take drug butterfly pea flower extract plus tb regimen drugs consisting of rifampicin, isoniazid, pyrazinamide, and ethambutol or monotherapy tb regimen drugs only every day for 2 months * willing to undergo treatment monitoring and visit the clinic once every 2 weeks for checkups and tests * keep a diary of their symptoms and the number of times they use a butterfly pea flower decocta extract


Eligibility criteria:
inclusion criteria: * pulmonary tb patients were positive based on the results of the rapid molecular test genexpert m. tuberculosis (mtb)/rifampicin (rif), * patients who were undergoing the initiation phase of anti-tb treatment for the first time, * non-multi drug resistant (mdr)/extensively-drug resistant (xdr) tb patients with first-line anti-tb treatment (rifampicin, isoniazid, pyrazinamide, and ethambutol), * patients \>18 years old, * patients who were willing to become research subjects and signed informed consent. exclusion criteria: * tb patients with human immunodeficiency virus (hiv) positive, * patients who did not complete the study, * patients with non-compliance in taking medication, * patients with comorbidities (autoimmune and cancer), * smoking patients, * patients contraindicated in using butterfly pea flower extract.

Keywords: anti-inflammatory agents butterfly pea flower cytokines tuberculosis therapy clitoria ternatea
comparison of the effect of warfarin and direct oral anticoagulants

Conditions: Anticoagulants and Bleeding Disorders; Gastrointestinal Hemorrhage

Summary: in this study, it was aimed to compare the frequency of new oral anticoagulants and warfarin usage, and to reveal the rates of recurrent upper gastrointestinal bleeding among patients who applied to our hospital with upper gastrointestinal bleeding

the data of all patients who applied to samsun training and research hospital internal medicine with a diagnosis of upper gastrointestinal bleeding and hospitalized by internal medicine and gastroenterology clinics or who underwent outpatient endoscopy between 01.01.2021 and 31.12.2021 were included. the patients' data were analyzed from the patient files and hospital automation system retrospectively. patients who had recurrent upper gi bleeding were detected by controlling them over the hospital software system and by reaching each patient again. the frequency of the new generation oral anticoagulants usage in patients with re-bleeding was determined, and data such as re-bleeding rate, length of hospital stay, need for transfusion, and mortality were analyzed in the groups who did not use this drug and those who used it. the patient demographics were also compared between the groups who were using the new generation oral anticoagulants, acetylsalicylic acid or warfarin.

Eligibility criteria:
inclusion criteria: * age \>18 years old * upper gastrointestinal bleeding * 12 months follow-up exclusion criteria: * age \<18 years old * lower gastrointestinal bleeding * esophageal variceal bleeding

Keywords: gastrointestinal system oral anticoagulant rebleeding upper gastrointestinal system bleeding