Kornimate/medical-research-clean huggingface dataset:
clinical trial to evaluate the regeneration of articular cartilage through arthroscopy after megacarti® application

Conditions: Osteoarthritis, Knee

Summary: the megacarti® is the decellularized allogeneic cartilage and acts as a cover after bone marrow stimulation to prevent the loss of blood clots and induces cartilage regeneration by assisting in the location of stem cells derived from bone marrow. during the 48-week confirmatory clinical trial of megacarti®, patients who simultaneously underwent high tibial osteotomy(hto) were treated with a group in which megacarti® was implanted after microfracture and a group in which microfracture alone was performed. cartilage regeneration is evaluated in patients with arthroscopy data at the time of fixation removal surgery.


Eligibility criteria:
inclusion criteria: 1. patients participating in the "clinical trial to evaluate the efficacy and safety of megacarti® ; cartilage defect treatment assisting cartilage regeneration in knee cartilage defects : multicenter, independent evaluator and subject blinded, microfracture comparative, superiority, randomized, confirmatory clinical study and 5 years follow up study" 2. patients who simultaneously underwent hto during knee joint cartilage surgery exclusion criteria: n/a
analysis of gerd symptoms using gastroesophageal reflux impact score questionnaire for quality of life

Conditions: Reflux Esophagitis (RE); Non-erosive Reflux Disease (NERD); Functional Heartburn (FH)

Summary: even the patients complain gerd symptoms such as heartburn and acid regurgitation the final diagnosis could be reflux esophagitis (re), non-erosive reflux disease (nerd) and even functional heartburn (fh). in addition, the gerd symptoms are consisted of esophageal symptoms and extraesophageal symptoms. thus it is necessary to use effective tool for the measurement of gerd symptoms and response of proton pump inhibitor in short time. several questionnaires have been made for the assessment of gerd symptoms in recent years however, their screening tools do not include the impact of symptoms on everyday life and take a long time to complete the questionnaires. the gerd impact scale (gis) questionnaire has been developed to compensate for this. it is a simple, one-page, questionnaire to communicate to the doctor the frequency of reflux symptoms and their effect on quality of life, recognizing that it might also prompt clinicians to make appropriate treatment for patients' symptoms. however, there was no report regarding comparison of the characteristics and response to ppi in re, nerd and fh groups using gis questionnaire so far.


Eligibility criteria:
inclusion criteria: * adult subjects (from 16 to 85 years old) * the subjects with gerd symptom who received 8 week ppi therapy exclusion criteria: * patients with a history of gastrointestinal surgery, barrett's esophagus, esophageal motility disorder, duodenal ulcer, benign gastric ulcer or gastroduodenal cancer and systemic disease requiring chronic medication (except for hypertension and diabetes mellitus) * patients who took h2 blocker or a ppi to relieve these symptoms within 4 weeks
a study to evaluate eli lilly's insulin dosing algorithm to control glycemia in insulin-treated adults with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of this study is to generate preliminary data in an inpatient setting to help optimize an insulin dosing logic (that decides how much to deliver insulin) for eli lilly's system.

after being informed about the study and potential risks, all participants giving written informed consent will undergo an admission visit to determine eligibility for study entry. participants who meet the inclusion and exclusion criteria will then participate in two 41-hour intervention visits using eli lilly's insulin dosing algorithm.

Eligibility criteria:
inclusion criteria: to be eligible for the study, all participants must meet the following criteria: 1. adult male or female ≥ 18 years of age. 2. type 2 diabetes mellitus has been clinically diagnosed (the diagnosis of type 2 diabetes is based on the investigator's judgment) for at least 12 months 3. using multiple daily insulin injections (one basal and ≥ 2 prandial doses) for ≥ 3 months. 4. using insulin glargine (u100 or u300), detemir, degludec, or nph. 5. most recent (in the last 6 month) hba1c ≤ 10%. 6. use of a glp1 agonist or sglt inhibitor for the past 3 months. exclusion criteria: participants who meet any of the following criteria are not eligible for the study: 1. severe hypoglycaemic episode ≤ two months before admission. 2. ongoing pregnancy, or any newly diagnosed pregnancy throughout the study 3. clinically significant nephropathy, neuropathy or retinopathy as judged by the investigator. 4. recent (within the past 6 months) acute macrovascular event (e.g. acute coronary syndrome or cardiac surgery). 5. peripheral vascular disease, foot ulcer, charcot arthropathy or any condition that limits ability to walk 6. other serious medical illness likely to interfere with study participation or with the ability to complete the trial by the judgment of the investigator. 7. use of oral hypoglycaemic agents besides sglti's, glp1 agonists, and or metformin and unwilling to discontinue for the run-in and intervention period.

Keywords: insulin pump therapy eli lilly
early treatment of atrial fibrillation for stroke prevention trial in acute stroke

Conditions: Acute Ischemic Stroke; Atrial Fibrillation

Summary: this study will determine whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care.

trial fibrillation is the single most frequent cause of ischemic stroke and associated with a high risk of recurrent stroke and cardiovascular complications. usual care comprises oral anticoagulation and rate control. however, it is unclear, whether early rhythm control therapy reduces the risk of recurrent stroke and cardiovascular outcomes in stroke patients with atrial fibrillation. the early treatment of atrial fibrillation for stroke prevention trial in acute stroke (east-stroke) will be an investigator-initiated, prospective, randomized, open, blinded outcome assessment (probe) interventional multi-center trial to test whether early, comprehensive, rhythm control therapy prevents adverse cardiovascular outcome in patients with acute ischemic stroke and atrial fibrillation compared to usual care. primary outcome is a composite of recurrent stroke, cardiovascular death, and hospitalization due to worsening of heart failure or acute coronary syndrome. secondary outcomes will involve a comprehensive array of clinical and safety parameters, health and socio-economic outcomes including patient reported outcome measures. in an adaptive design, up to 1,746 patients will be enrolled to demonstrate the expected treatment effect with 90% power.

Eligibility criteria:
inclusion criteria: * acute ischemic stroke in the previous four weeks, diagnosed by imaging (ct or mri) or clinical diagnosis * possibility to start the trial treatment within 4 weeks after stroke, and as soon as clinically justifiable * af first detected ≤1 year prior to randomization * informed consent exclusion criteria: * end-stage cancer or life-expectancy \< 12 months due to other advanced co-morbid illness * prior af ablation or surgical therapy of af * patients not suitable for rhythm control of af due to cardiac conditions

Keywords: acute ischemic stroke atrial fibrillation rhythm control ablation antiarrhythmic drugs
determinants of pterygium occurrence and recurrence in a rural african population

Conditions: Pterygium

Summary: the aim of the study is to find out why pterygium occurs and recurs in a rural african population. participants will be interviewed on personal and lifestyle information, family history of pterygium, environmental exposure and history of previous eye inflammation. they will undergo eye examination and photography. those with pterygium will be operated on to remove pterygium and followed up to detect any recurrence and complications of surgery. the excised pterygium will be examined pathologically and genetically; participant's blood will also be examined genetically. data will be analyzed for statistically significant differences in findings between pterygium and pterygium free participants. the study hypothesis is that multiple factors are responsible for the occurrence and recurrence of pterygium in a rural african population.


Eligibility criteria:
inclusion criteria: 1. pterygium at least 1.5mm in extent 2. both male and female 3. age range 21-65 years 4. consenting to participate in study 5. unilateral and bilateral pterygium 6. all grades of pterygium exclusion criteria: 1. previous cataract, corneoscleral and glaucoma surgery or corneoscleral trauma and corneolimbal scars 2. pseudopterygium or signs of malignancy on pterygium 3. recurrent pterygium 4. sufferers of collagen vascular disease, scleritis or diabetes -
risk factors for complications after carotid endarterectomy

Conditions: Postoperative Complications; Postoperative Cognitive Dysfunction

Summary: this study may determine the incidence of complications that occur after patients undergo a surgery called carotid endarterectomy (cea), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. medical records will be accessed to find any information pertaining to postoperative complications. additionally, it may determine the cognitive dysfunction of patients undergoing cea, assessed by mini mental status examination (mmse).

this is a multicenter prospective observational study; data will be collected from two sites: the lead site in columbus, ohio, usa and an international site in girona, spain for a total of 354 patients. the objective of this study is to determine the incidence of complications that occur after patients undergo a surgery called carotid endarterectomy (cea), which is a surgery that aims to decrease the risk of strokes in patients with a condition called carotid stenosis. patients who undergo cea are at increased risk of cardiovascular complications because of the high incidence of coexisting heart disease, high blood pressure, and diabetes. common complications that occur after cea are wound hematoma (collection of blood at the wound) and intracerebral hemorrhage (bleeding in the brain). medical records will be accessed to find any information pertaining to postoperative complications. another objective of this study is to determine the cognitive dysfunction of patients undergoing cea. this will be measured by a mini mental status examination (mmse) which will occur in person before the surgery and 30 days after the surgery over the phone. this study may provide data that will help identify how to optimize recovery for future cea patients.

Eligibility criteria:
inclusion criteria: * patients males or females, 18 years of age and older * scheduled to undergo carotid endarterectomy exclusion criteria: 1. pregnant women 2. incarcerated individuals 3. patients not able to consent for themselves 4. any disease or condition deemed by the investigator to disqualify the patient 5. participating in any interventional clinical trial

Keywords: endarterectomy
effects of electroacupuncture with different frequencies for major depressive disorder

Conditions: Major Depressive Disorder

Summary: two groups of subjects will be included 55 subjects in electroacupuncture with 2hz group, 55 subjects in the electroacupuncture with 100hz group. the clinical efficacy of electroacupuncture with different frequencies (2 hz, 100 hz) in the treatment of mdd will be observed by evaluation indicators, such as self-rating depression scale and hamilton depression scale.


Eligibility criteria:
inclusion criteria: 1. patients suﬀering from mdd in accordance with the diagnostic criteria; 2. hamilton depression scale score is between 21 and 35 (mild to moderate mdd); 3. 18≤age≤60 years, both gender; 4. patients who have not used antidepressants and other psychiatric drugs (including traditional chinese medicine), or have used them but have stopped for at least 2 weeks; 5. patients have clear consciousness and could communicate with others normally; 6. patients could understand the full study protocol and written informed consent is provided by themselves. note: subjects who meet the above six items will be included. exclusion criteria: 1. patients with bipolar disorder; 2. patients with schizophrenia or other mental disorders; 3. patients with severe medical diseases, tumors or diseases of the central nervous system; 4. patients suﬀering from severe depressive episode with psychotic symptoms; 5. suicidal patients; 6. patients with seasonal depression; 7. patients with organic depression; 8. patients with alcohol or drug addicts; 9. patients using other therapies; 10. patients in pregnancy or lactation; 11. patients suffering from cognitive dysfunction, aphasia or other diseases that cannot cooperate with treatment; 12. patients with pacemakers; 13. patients who are not suitable for electroacupuncture.
resistance training and sex hormone concentrations during the menstrual cycle

Conditions: Women's Health

Summary: although there are numerous studies showing effects of aerobic training on sex hormone concentrations, research analyzing the fluctuation of sex hormones in response to resistance training (rt) is lacking. the objective of this project is to analyze estradiol (e2) and progesterone (p4) responses to an acute resistance training session throughout different phases of the menstrual cycle. this proposed research has strong implications for exercise prescription and for women in general, but more importantly will allow exercise physiologists, coaches, personal trainers, or nutritionists optimize exercise programming around women's menstrual cycle.


Eligibility criteria:
inclusion criteria: * eumenorrheic females * age 18-45 years old * bmi of 18.5-34.99 kg/m2 exclusion criteria: * practice exercise more than 2 days/week in the last 3 months. * cardiovascular, metabolic, pulmonary or muscular-skeletal condition * taking medications that affect metabolism (e.g. oral contraceptives) * irregular menstrual cycles

Keywords: estrogen progesterone menstrual cycle resistance training
in utero capacity formation and socio-economic outcomes

Conditions: Folic Acid Deficiency

Summary: because of the high returns of schooling in developing countries, policymakers pay a lot of attention to increasing school access. but if the mother is deficient in key micronutrients, brain development can biologically constrain children's demand for education. to execute this strategy, the investigators collect cohort observational data on a previous randomized controlled trial with micronutrient supplements offered to hiv-negative pregnant women in dar es salaam, tanzania, between 2001 to 2003.

this is a cohort study which collected follow-up observational data on households which were offered micronutrient supplements. the followup study outcomes include various socio-economic household characteristics and parental post-natal behaviors.

Eligibility criteria:
these were individuals from the larger study and this study is an observational follow-up.
granuloma annulare treated with rifampin, ofloxacin, and minocycline combination therapy

Conditions: Granuloma Annulare

Summary: granuloma annulare is a benign, usually self-limiting, cutaneous dermatosis, which typically presents as asymptomatic, flesh-colored or red papules, frequently arranged in an annular pattern on the distal extremities. although localized granuloma annulare is most commonly observed, a generalized or disseminated form can occur. the etiology of granuloma annulare is unknown, however, multiple inciting factors have been proposed. the purpose of the investigators is to review the outcomes of treatment of granuloma annulare (ga) resistant to standard regimens that resolved after a 3-months treatment course of monthly rifampin, ofloxacin, and minocycline (rom) therapy, successfully used to treat paucibacillary leprosy, a disease with clinical and histopathologic similarity to ga.

we will document the regimen treatment each patient has had and then review the following from the patient's chart to target our specific aims as outlined above. 1. what previous treatment options have been or/are currently being used? 2. how long did the patient take the treatment for? 3. was the patient able to discontinue or become less dependent on prior treatment? 4. was the disease process slowed by the treatment?; 5. were there any side effects that the patient experienced with treatment?

Eligibility criteria:
inclusion criteria: * patients with granuloma annulare who are resistent to the standard treatment. exclusion criteria: * response to the standard treatment of granuloma annulare.

Keywords: granuloma annulare, rom
antibody detection in covid-19 cured patients (sars-cov-2-cz-immunity)

Conditions: COVID; SARS-CoV-2

Summary: the aim of the sars-cov-2-cz-immunity study is to determine the time profile of the presence of antibodies against sars-cov-2 in blood plasma by quantification of antibodies or performing a rapid test in covid-19 cured patients.

covid-19 is caused by a new type of coronavirus called sars-cov-2. it is a highly infectious disease, manifested mainly by fever, respiratory problems, muscle pain, and fatigue. however, despite the publication of hundreds of papers in the literature, fundamental information about the spread and course of the disease is still lacking in covid-19. one of such key information is the time profile of the presence of antibodies against sars-cov-2 after the disease. the sars-cov-2-cz-immunity study is aiming at the determination of the time profile of the presence of antibodies against sars-cov-2 in blood plasma by quantification of antibodies or performing a rapid test in covid-19 cured patients.

Eligibility criteria:
inclusion criteria: * signed informed consent * residing in prague, central bohemian region or south moravian region * demographic criteria: persons aged 8-17 and persons aged 18 and more * clinical criteria: (i) diagnosis of covid-19 confirmed by pcr (ii) cured patients: clearance of sars-cov-2 viral rna demonstrated by two consecutive negative rt-pcr results (iii) without acute health problems

Keywords: sars-cov-2 antibody humoral immunity
pilot randomized evaluation of butyrate irrigation before ileostomy closure on the colonic mucosa in rectal cancer patients (butyclo)

Conditions: Rectal Cancer

Summary: low anterior resection with total mesorectal excision and diversion loop ileostomy is a gold standard surgical treatment in rectal cancer. ileostomy reversal performed in a second stage carries a high burden of postoperative complications. terminal ileum and colon dysfunction during bowel disconnection could negatively influence postoperative morbimortality after loop ileostomy reversal in rectal cancer patients. colonic microflora performs anaerobic breakdown of dietary fibre that reaches the gut in regular patients without ileostomy. one of the short-chain fatty acids (scfas) produced by bacteria is butyrate, the preferred substrate to be oxidized by colonocytes. the effects of butyrate irrigations before ileostomy closure on colonic mucosa will be studied in 45 rectal cancer patients. the effects of butyrate irrigation trough the efferent limb of loop ileostomy before its closure will be compared to the saline and non-irrigations group. short term outcomes, colonic microbiota composition and functional outcomes will be evaluated after ileostomy reversal.


Eligibility criteria:
inclusion criteria: * patients over 18 years of age * patients waiting for an elective ileostomy reversal after rectal cancer surgical treatment exclusion criteria: * inflammatory bowel disease * abnormal preoperative findings trough rectoscopy or ct-enema scan that precluded a safe ileostomy closure * ileal pouch, poor treatment compliance * pregnancy or lactation * unwillingness to use adequate contraception throughout the study period * combined surgeries * the impossibility to understand the informed consent.

Keywords: ileostomy closure butyrate enemas microbiota rectal cancer
measuring the effect of radiation therapy on patient activity levels

Conditions: Head and Neck Cancer; Prostate Cancer; Breast Cancer; Lung Cancer

Summary: the goal of this study is to measure the effect of radiation therapy on the activity levels of patients. this will be achieved by tracking their activity levels during a treatment course of radiation therapy.

at the university of pittsburgh (upmc) st. margaret and upmc shadyside, in the department of radiation oncology, breast, prostate, head and neck, and lung cancer patients will receive the standard treatment for their cancer and in no way will this study interfere with this treatment. prior to initiation of radiation, consenting patients will be given misfit activity tracking devices (accelerometers) to be worn on their wrist to track their activity levels throughout the course radiation therapy. bracelets will be given to patients by the pi or co-investigators (mds involved in patient's care) at date of consent and returned at completion of the study. the bracelets will track daily steps taken, calories burned, miles walked, and restful and restless sleep. again, the purpose of the study is merely to measure the affect radiation therapy has on activity levels of patients.

Eligibility criteria:
inclusion criteria: * diagnosis of breast, prostate, lung or head and neck cancer * eastern cooperative oncology group (ecog) performance status of 0-1 * ability to walk 100 feet without rest * signed informed consent exclusion criteria: * any other noncutaneous cancer diagnosis under active treatment * known metastatic disease
cannabidiol for the treatment of severe (grades iii/iv) acute graft-versus-host disease

Conditions: Acute-graft-versus-host Disease

Summary: graft-versus-host-disease (gvhd) is a major obstacle to successful allogeneic hematopoietic cell transplantation (allohct). cannabidiol (cbd), a non-psychotropic ingredient of cannabis sativa possesses potent anti-inflammatory and immunosuppressive properties. in a recent phase 2 study, cbd has been shown to be safe and reduced significantly the incidence of acute gvhd compared to control patients with a hazard ratio of 0.3. based on these results the investigators propose a phase 2 study to explore the efficacy of oral cbd in the treatment of severe (grades iii/iv) acute gvhd, a pathology with a dismal prognosis.


Eligibility criteria:
inclusion criteria: 1. patients 18 years or older 2. after allogeneic transplantation 3. grade iii or iv acute gvhd 4. no psychiatric contra-indication 5. informed consent exclusion criteria: 1. history of psychosis 2. asthma 3. known allergy to cannabis constituents