Kornimate/medical-research-clean huggingface dataset:
a comparison of farabloc fabric with placebo on alleviation hot flash in menopausal women

Conditions: Menopause

Summary: this is a prospective, randomized, double-blind, crossover study. the purpose of this study is to determine whether farabloc fabric is effective in alleviation of hot flash symptoms in menopausal women. this study will require all prospective participants to fill out a week of hot flash diary to determine eligibility before beginning the study. all prospective participants will be assessed for hot flash frequency, hot flash distress and hot flash severity according to their perception in the hot flash diary during the experimental period.

fifty menopausal volunteers will be randomly assigned to two groups, one receiving farabloc fabric containing farabloc (experimental), and the other a similar-appearing fabric made of nylon (placebo). all eligible participants will be selected by the initial interview. the following information will be collected during interview process. * address * medical history * concomitant medication * allergies participants will be asked the following: 1. on a scale from 1 to 10, how much are you bothered by your hot flashes? 2. do these hot flashes wake you up at night? around how many times do they occur at night? 3. what are you expectations about this study? a menopause rating scale questionnaire will be completed by the potential participant to assess symptoms eligible patients from each group will initially undergo a 7 day washout period before intervention in order to eliminate any effects of hormone replacement therapies (hrt) or herbal supplements that subjects may be using prior to participation in the study. subjects will be randomized to receive a farabloc fabric or placebo fabric for one week. after this, the two groups will undergo a second 7 day washout period before crossing over to the other fabric. once crossed over, participants will use the allocated fabrics for another week. participants will be asked not to take their usual hrt or herbal supplements for the entire experimental duration in this study in order to produce impartial, precise and reliable results. the manufacturer will assign codes for placebo fabric or experimental farabloc. the randomization code will be broken at the completion of the study for data analysis.

Eligibility criteria:
inclusion criteria: * women with 12 months amenorrhea * experiencing more than 2 nocturnal hot flashes nightly. exclusion criteria: * other medical conditions associated with night sweats * currently on medication associated with night sweats * less than 2 nocturnal hot flashes per night * allergies to metals * abnormal mental status * mrs scale rating of mild or above * currently on hormone replacement therapy or herbal supplements and cannot safety discontinue these for the duration of the study.

Keywords: hot flash farabloc menopausal women
long-term follow-up safety monitoring of patients dosed in the first-in-man phase i/ii study of tt-034.

Conditions: Hepatitis C

Summary: this is a long-term safety follow-up protocol for subjects who received tt-034 under the b2801001 protocol and consists of monitoring for at least 4.5 years.

the main purpose of this follow-up study is to detect events suggestive of delayed adverse effects of the study drug by review of clinical histories and discussion with subjects to identify/elicit significant medical events, including but not limited to hematologic, malignant, autoimmune, neurologic, and hepatic events.

Eligibility criteria:
inclusion criteria: * prior enrollment in study b2801001 and dosing with tt-034 * an informed consent form for this study signed and dated by the subject or a legally acceptable representative exclusion criteria: * there are no specific exclusion criteria for this follow-up study

Keywords: adeno-associated viral vectors adeno-associated virus aav aav8 ddrnai shrna rnai hepatitis chronic hepatitis c hcv chc genotype 1
dose-ranging study evaluating ave2268 in patients with type 2 diabetes not adequately controlled by a metformin treatment

Conditions: Type 2 Diabetes Mellitus

Summary: dose-ranging study of ave2268 in the management of patients with type 2 diabetes mellitus also receiving metformin. its main objectives will be to assess the effects of several doses of ave2268 on mean plasma glucose. its secondary objectives will be to assess the effects of ave2268 on plasma glucose (fasting and post-prandial), and also the safety and tolerability of ave2268.


Eligibility criteria:
inclusion criteria: * type 2 diabetes mellitus, as defined by the american diabetes association, for at least one year at the time of screening. * hba1c measured at visit 1 in the range of ≥ 7.0 and \< 9.0 %. * stable metformin treatment (dose ≥ 1.5g/day for at least 3 months prior to enrollment in the study). no other antidiabetic medications are permitted for 3 months prior to enrollment. exclusion criteria: * pregnant or breast-feeding women. * women of childbearing potential not protected by medically approved contraceptive method of birth control. * bmi \>40kg/m2 * diabetes other than type 2 diabetes. * subjects with "brittle-diabetes" or any hospitalization or emergency room visit due to poor diabetic control within the past 6 months, previous history of diabetes related dehydration leading to hospitalization, history or evidence of ketoacidosis. * presence or history of cancer within the past five years. * evidence within the past 6 months of myocardial infarction, stroke, retinopathy requiring laser surgery, or heart failure requiring hospitalization. * impaired hepatic tests, impaired renal function. * history or evidence of clinically relevant renal or urological disorder. * the investigator will evaluate whether there are other reasons why a patient may not participate.

Keywords: type 2 diabetes mellitus
effect of cgm on glucose control in non-insulin-treated patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus

Summary: the clinical value of cgm for diabetic patients undergoing insulin therapy has been widely recognized, but the evidence-based support for its use in non-insulin-treated type 2 diabetic patients remains insufficient. the primary objective of this study is to evaluate the effect of real-time continuous glucose monitoring (cgm) compared with self-monitoring of blood glucose on glycemic control in adults with non-insulin treated type 2 diabetes.


Eligibility criteria:
inclusion criteria: * (1)subjects aged ≥18 years at screening (based on the day of signing the informed consent form) and of any gender * (2)patients diagnosed with type 2 diabetes * (3)prior to the screening, glycemic control was suboptimal with diet, exercise control, and oral medication or glucagon-like peptide-1ra (glp-1ra) therapy maintained for more than 3 months, 7.5%≤hba1c≤10% * (4)subjects voluntarily sign an informed consent form exclusion criteria: * (1)patients treated with insulin within 3 months prior to screening * (2)currently or have used a cgm device within 3 months prior to enrollment * (3)serious skin disease at the sensor placement site, allergy to tape or adhesives * (4)pregnant females, those with a positive pregnancy test result at screening, or those who plan to become pregnant during the study * (5)those who are participating or will participate in other clinical trials * (6)those who, in the opinion of the investigator, should not participate in this clinical trial, such as: ①those who have a history of eye trauma or other diagnosed eye diseases resulting in visual impairment, etc.; ②those who are unwilling or unable to fully understand or cooperate due to speech disorders; ③those who suffer from mental disorders
budesonide in patients with immune mediated enteropathies

Conditions: Enteropathy; Celiac Disease; CVID Enteropathy; Collagenous Sprue; Autoimmune Enteropathy

Summary: researchers are trying to determine if withdrawal of budesonide therapy in patients with immune-mediated enteropathies doing well on therapy will result in worsening symptoms, histology, quality of life, and micronutrient/nutritional status when compared to continued therapy.

this study aims to evaluate patients with small intestinal diseases caused by the immune system (refractory celiac disease type 1, cvid enteropathy, autoimmune enteropathy, and collagenous enteropathy) who have had improvement in symptoms and small intestine healing with oral budesonide. patients who meet inclusion criteria and agree to enter the study will be included for 12 weeks or until they choose to discontinue or there are concerns for safety. at the beginning of the study, patients will undergo questionnaires, blood draw, urine and stool collections, physical exam, and an upper scope (esophagogastroduodenoscopy) with biopsies from the small intestine. they will then be randomized to either continued therapy on their current dose and formulation of budesonide (medication provided by the study) or to withdrawal of the medication over 2 weeks and then no medication during the study. daily questionnaire on symptoms will be recorded. patients will be assessed in the clinical research unit monthly during the study with a questionnaire, physical exam, blood draw, and urine/stool collections. finally, at the end of the trial (12 weeks) or at the time of withdrawal from the trial, the patients will complete questionnaires, physical exam, blood collection, urine/stool collection, and upper scope (esophagogastroduodenoscopy) with small bowel biopsies.

Eligibility criteria:
inclusion criteria * patients will be recruited from the division of gastroenterology and hepatology and the mayo clinic in rochester, mn. * adult patients with immune mediated enteropathies who have had improvement in symptoms and histology on oral budesonide therapy. exclusion criteria * age \<18 years * positive stool gluten testing in patients with refractory celiac disease * small bowel malignancy or history of small bowel malignancy * refractory celiac disease type 2 * post-transplant lymphoproliferative disorder associated enteropathy * no prior improvement in symptoms and histology with budesonide therapy * discontinuation of budesonide therapy prior to the trial * other concurrent systemic corticosteroids * other immune mediating medications, for example but not limited to azathioprine, 6-mercaptopurine, cyclosporine, methotrexate, anti-tnf monoclonal antibodies, alpha-4 beta-7 integrin inhibiting monoclonal antibody, interleukin 12/23 inhibiting monoclonal antibody, jak inhibitors.
dapagliflozin to prevent atrial fibrillation recurrence after transcatheter pulmonary venous isolation.

Conditions: Atrial Fibrillation Recurrent; Pulmonary Venous Isolation; Catheter Ablation; Sodium-glucose Co-transporter 2 Inhibitors

Summary: transcatheter left atrial antral ablation, aiming at complete electrical isolation of the pulmonary veins (pvi), has become mainstay in atrial fibrillation (af) treatment. this approach has been proved superior to medical rhytmh control strategy in maintaining sinus rhythm. moreover pvi has been associated with significant survival benefit in patients with heart failure and reduced left ventricular ejection fraction. nevertheless, despite progress in the field of catheter ablation, recurrence rates remain high. inhibitors of type 2 sodium- glucose co-transporter (sglt2i) is a relatively recent addition to the array of anti-diabetic agents, becoming part of everyday clinical practice. however, although sglt2i were first used solely as antidiabetics because of their glycosuric effect, further research demonstrated that these drugs may independently reduce cardiovascular events, especially in patients with heart failure, a benefit that was consistent among diabetic and non-diabetic patients. moreover, pleiotropic effects have been observed, including a reno-protective action. these findings suggest that sglt2i mechanisms of action extend beyond the obvious increase in urinary sodium and glucose excretion. various studies propose that these drugs promote favourable metabolic changes in myocardial energetics, while they also inhibit inflamation and sympathetic activation, resulting in restriction of induced fibrosis and structural remodeling, which are key elements in atrial fibrillation generation and maintenance. these findings suggest that the use of sglt2i could offer antiarrhythmic benefit by reducing and/or reversing structural and electrical remodeling, leading to the assumption that use of theese drugs could reduce recurrences after transcatheter af ablation.


Eligibility criteria:
inclusion criteria: age\>18 years atrial fibrillation (paroxysmal or sustained); written informed consent; glomerular filtration rate (gfr) \>45 ml/min/1.73m2 (cockroft-gault equation) exclusion criteria: hypertrophic cardiomyopathy (left ventricular wall thickness ≥15mm, not explained by abnormal pressure/volume conditions); severe mitral valve stenosis (as defined in european guidelines); active malignancy; participation in other intervention studies; pregnancy or willing of pregnancy during the follow up period guideline class i or equivalent indication for treatment with a sglt2 inhibitor \*eligible patients randomized in the active comparator arm will be also included in a prospective observational registry study regarding the role of sglt2 inhibitors in post-ablation af recurrence.

Keywords: dapagliflozin sodium-glucose co-transporter 2 inhibitors atrial fibrillation recurrence catheter ablation sglt2 inhibitors
positive feedback vs. no-feedback games for behavioral change

Conditions: Major Depressive Disorder; Low Mood

Summary: we aim to investigate here whether we can develop a reinforcement learning game which provides game-based feedback to encourage positive actions (behaviors) both inside and outside of the game. does providing positive reward when participants make decisions which are associated with value-based actions (like those in ba) result in different game decisions? we propose that it will increase positive actions in the game. and, secondly, how does it affect short-term behavior (in one week)? we propose that it will increase pro-health activities and may reduce depressive symptoms.

we know that behavior influences mood -- our best interventions to improve mood rely upon the relationship between these. treatments like this are thought to work in part by helping individuals to increase value-derived behaviors; participants are given guidance which results in an increase of positive behaviors and a decrease of coping behaviors that don't help -- that is, their health-seeking behavior is reinforced while behaviors that diminish health are reduced. in past work, we showed that a text-based game could be used to explore what sort of decisions people would make in certain environments. that game showed associations between in-game behaviors and real-life depressive symptoms and actions. such work focuses on low-level symptoms of depression -- increasingly common, especially after the onset of the covid-19 pandemic. we aim to investigate here whether we can develop a reinforcement learning game which provides game-based feedback to encourage positive actions (behaviors) both inside and outside of the game. thus, the experiment described below and proposed in this application would test the role of positive rewards (positive-feedback) in a dichotomous-choice game, compared to neutral (no-feedback).

Eligibility criteria:
inclusion criteria: * 18-34 years old * fluent in english * based in the united states exclusion criteria: * none
investigation of muscle activity pattern of gluteus medius and tensor fascia lata in patients with pfps

Conditions: Patellofemoral Pain Syndrome

Summary: the purpose of this study is to investigate the muscle activity of gluteus medius and tensor fascia lata in health control group and patients with pfps during submaximal isometric muscle contraction.the research question :is there any difference of muscle activity of gluteus medius and tensor fascia lata between health control group and patients with pfps during submaximal isometric muscle contraction ？null hypothesis:there is no difference of muscle activity of gluteus medius and tensor fascia lata between health control group and patients with pfps during submaximal isometric muscle contraction.

basic data - name, age, sex, bw, bh, pain vas scale（vas-activity）, affected side, dominate leg, symptom duration, activity level measurement * flexibility of iliotibial band：ober test * emg data collection during 8s submaximal muscle contraction * muscle strength measurement of hip abductors

Eligibility criteria:
inclusion criteria: * 20-50 years old * insidious onset of symptoms * pain exist at least 3 month, vas activity\>4 * two of the following activities induce pain at anterior or retropatellar site prolonged sitting, stair-climbing, squatting, running, kneeling, and hopping/jumping * diagnosed by an orthopedic surgeon exclusion criteria: * history of lower extremity fracture or operation * neurological disease involved * observed knee deformity * other well-defined musculoskeletal problems in lower extremity

Keywords: patellofemoral pain syndrome electromyography gluteus medius tensor fascia lata
closed loop insulin pump therapy after islet auto-transplantation

Conditions: Chronic Pancreatitis; Diabetes Mellitus

Summary: the purpose of this study is to determine the effectiveness of closed loop insulin pump therapy to control blood sugar following total pancreatectomy and islet auto-transplantation (tpiat).

objectives and hypotheses the main objective of this study is to determine if a closed loop insulin system can successfully achieve tighter blood sugar control than the current multiple daily injection regimen. the investigators hypothesize that the average blood glucose will be lower in the closed loop group than the control group, there will be less glucose variability in the closed loop group than the control group, and there will be less total time spent in hyperglycemia and hypoglycemia in the closed loop group than in the control group. the investigators also will investigate insulin requirements and islet function in the first 6 months post-transplant in the closed loop group the investigators hypothesize that the insulin requirements will be lower and the c-peptide levels higher in the closed loop group than in the control group.

Eligibility criteria:
inclusion criteria: * patients undergoing total pancreatectomy and islet auto-transplantation. * patients ages 21 to 64 years old exclusion criteria: * preexisting diabetes * use of acetaminophen during study period, which interferes with cgm sensor function * any medical condition requiring corticosteroids * severe psychiatric disease or developmental delays, that might interfere with the ability to provide informed consent * any other medical condition which in the opinion of the investigators impairs the person's ability to safely participate in the trial

Keywords: total pancreatectomy islet auto-transplantation closed loop insulin pump
neutrophil gelatinase-associated lipocalin in major abdominal surgery

Conditions: Acute Kidney Injury

Summary: acute kidney injury (aki) after major surgery is a well-known complication. the incidence of aki after major surgery ranges from 13% to 50%. the morbidity and mortality rates increase in patients with aki due to the treatments applied and the prolonged hospital stay. in addition, as a result of all these processes, hospital costs increase and burden the health systems. classifications such as acute kidney injury network (akin) or kidney disease improving global outcomes (kdigo) are used in the diagnosis of aki. in these classifications, evaluation is made based on kidney damage, serum creatinine (scr), and urine output. however, scr; is affected by factors such as age, gender, diet, muscle mass, and medication. in addition, in healthy individuals in terms of kidney reserve, a loss of up to 50% in nephrons is tolerated by the body and there is no change in scr values. therefore, the onset of the increase in scr values occurs 48-72 hours after kidney damage. this situation causes delays in the treatments applied and increases morbidity and mortality rates. for these reasons, interest in biomarkers used in the early diagnosis of aki has increased in recent years. neutrophil gelatinase-associated lipocalin (ngal) is a 25 kda, neutrophil-derived molecule from the lipocalin family. it is also secreted in small amounts from kidney, prostate, and respiratory tract epithelial cells. after ischemic and nephrotoxic acute tubular necrosis, ngal levels peak at the 3rd hour and remain elevated for approximately 24 hours. in patients who do not progress to aki, ngal levels begin to decrease in the 1st hour after injury. when the current literature is examined, scientific studies on ngal have mostly been carried out on cardiovascular surgery cases to date. there are very few studies evaluating ngal levels in patients who develop aki after major abdominal surgery. these few studies evaluated either serum ngal or urinary ngal levels. in this study, both serum ngal and urinary ngal will be measured simultaneously to detect aki that may develop in patients undergoing major abdominal surgery.


Eligibility criteria:
inclusion criteria: * asa i-iii, * patients undergoing elective major abdominal surgery exclusion criteria: * chronic renal failure, * using nephrotoxic drugs, * patients with a history of kidney transplantation or nephrectomy

Keywords: acute kidney injury neutrophil gelatinase-associated lipocalin major abdominal surgery
improving health of patients with colon cancer following surgery: a trial of sa-ican via videoconferencing

Conditions: Colon Cancer

Summary: the purpose of this study is to assess the impact of more frequent follow-up (by videoconference) of these patients. videoconference is a method of communication over a distance. in this method, the patient will hear the person's voice (like on the telephone) and will see that person over video. the study will compare more frequent follow-up of patients by videoconferencing to routine follow-up of patients. the investigators will compare each type of follow-up to see the effect on the number of times patients need to visit emergency rooms or need admission to hospitals. the study will also look at the difference between each type of follow-up on patients' quality of life and social support thirty days after hospital discharge. the study will also measure satisfaction and acceptability of this intervention among those who had follow-ups by videoconference.


Eligibility criteria:
inclusion criteria: * age 65 or older. * newly diagnosed cancer. * referred to the geriatrics service for pre-operative evaluation before surgical resection of his/her tumor. exclusion criteria: * inability to comprehend english. * deafness , measured by the hearing handicap inventory for the elderly screening version (hhie-s) \[16\], score equal or above 30. (appendix 5) * cognitive impairment (score of 0-1 in mini-cog test). * nursing home resident. * planned hospital length of stay of one day or less.

Keywords: videoconferencing following surgery 14-213