Kornimate/medical-research-clean huggingface dataset:
adapting an evidenced-based weight management intervention and testing strategies to increase implementation in community mental health programs

Conditions: Overweight and Obesity

Summary: this is a pilot randomized clinical trial testing an implementation intervention to support delivery of a behavioral weight loss program at community mental health programs.

this is a pilot randomized clinical trial testing an implementation intervention to support delivery of a behavioral weight loss program at community mental health programs. investigators will conduct a pilot trial testing a standard and an enhanced implementation intervention. the evidenced based intervention investigators are basing the behavioral weight loss program on is achieve, and investigators are calling the translated weight loss program achieve-d. the standard version of the implementation intervention, which will train community mental health program staff to become achieve-d coaches and peers to become achieve-d peer-leaders, will include in-person and online training and avatar-assisted motivational interviewing practice, as well as organizational strategy meetings. the enhanced implementation intervention will include all of these strategies + performance coaching for achieve-d coaches.

Eligibility criteria:
coaches - * adult staff or peer at community mental health program * willing and able to participate in training and delivery of intervention consumers- inclusion criteria: * age 18 and older * enrolled in a psychiatric rehabilitation program * bmi ≥ 25 kg/m2 * willing to make changes in diet and exercise to lose weight * willing to attend the achieve group sessions virtually or in-person at least once per week * ability to use a computer or tablet * competent and willing to give informed oral consent * completion of baseline data collection exclusion criteria: * any underlying medical conditions that could seriously reduce life expectancy, ability to participate in the study, or for which dietary change/physical activity/weight loss may be contraindicated e.g., lung disease requiring supplemental oxygen liver failure history of anorexia nervosa or bulimia stage v kidney disease on dialysis cardiovascular event in the last 6 months including unstable angina, myocardial infarction, congestive heart failure, transient ischemic attack, or stroke * insulin dependent diabetes * inability to walk unassisted (e.g., uses a cane, walker, etc) * pregnant, breastfeeding, or planning a pregnancy during study period * prior or planned bariatric surgery * use of a prescription anti-obesity medication or over-the-counter orlistat within the past 3 months * self-reported weight loss of \>20 lbs in the last 3 months * active substance use disorder, alcohol use disorder, or problem drinking (more than 14 drinks per week for women, more than 21 drinks per week for men) * planning to leave mental health program or move out of geographic area within 12 months * weight greater than 440 pounds (so as not to exceed capacity of study scale) * investigator judgment (e.g., for concerns over safety, adherence or follow-up)
karydakis flap versus burow's triangle advancement flap in the surgery of sacrococcygeal pilonidal sinus disease

Conditions: Pilonidal Sinus; Sacrococcygeal Pilonidal Disease

Summary: in this study, we aim to compare the karydakis flap and burow's triangle advancement flap techniques applied in the surgical treatment of pilonidal sinus in terms of complications, time to return to normal activity, and recurrence.

pilonidal sinus disease (psd) is a chronic and inflammatory disease that is often generated in the sacrococcygeal region. it is commonly observed in puberty and young adult period and usually affects men. the incidence of pilonidal sinus disease is 26:100,000 and rising globally. psd risk factors contain young age, obesity, male gender, mediterranean ethnicity, deep natal cleft, hairiness, and poor hygiene. it has been shown that psd incidence increases in parallel with body weight. the precise etiology of pilonidal sinus disease is unclear. many conservative and surgical methods have been described in treating pilonidal sinus disease. after the sinus area is excised, excision with laying open (secondary healing), excision with primary closure, marsupialization, and various flap techniques can be applied in surgical treatment. the primary principle in treatment is to ensure that the patient returns to normal life as soon as possible and eliminate recurrences. although the best surgical technique in treating pilonidal sinus is controversial, the ideal operation should be cost-effective, simple to perform, short hospital stay, and have a low recurrence and complication rates. there is no definite consensus on an ideal technique yet. in this study, we aim to compare the karydakis flap and burow's triangle advancement flap techniques applied in the surgical treatment of pilonidal sinus in our clinic in terms of complications (wound dehiscence, seroma, hematoma, surgical site infection), time to return to normal activity, and recurrence.

Eligibility criteria:
inclusion criteria: * patients between the ages of 18-65 * primary pilonidal sinus disease * no abscess and absence of active infection during the operation exclusion criteria: * patients under the age of 18 and over the age of 65 * recurrent pilonidal sinus cases * patients with chronic comorbidities such as immunosuppression, collagen tissue disease, insulin-dependent diabetes mellitus, and neurological disease * patients with an asa score of 3-4 * patients with a body mass index greater than 35 kg/m2 * patients with drug and alcohol addiction

Keywords: karydakis flap pilonidal cyst
a 16 week study of hrs-7535 in adults with type 2 diabetes mellitus

Conditions: Type 2 Diabetes

Summary: the aim of this trial is to evaluate the efficacy and safety of hrs-7535 in subjects with type 2 diabetes mellitus.


Eligibility criteria:
inclusion criteria: 1. male or female, 18-75 age years, both inclusive; 2. type 2 diabetes mellitus diagnosed for at least 3 months before the screening visit; 3. hba1c 7.5-11.0% (both inclusive) by local laboratory analysis; 4. treated with conventional lifestyle intervention and stable treatment with metformin (≥1000 mg/day) at least 8 weeks prior to screening. 5. body weight of at least 50 kg; and body mass index (bmi) within the range of 19 to 40 kg/m2 (inclusive); exclusion criteria: 1. known or suspected allergy to the investigational drug or its components or excipients. 2. diagnosed or suspected with type 1 diabetes mellitus, special types of diabetes or secondary diabetes. 3. have a history of acute complications of diabetes (diabetic ketoacidosis, lactic acidosis, hyperglycaemic hyperosmolar state, etc.) within 6 months prior to screening. 4. proliferative retinopathy, maculopathy, painful diabetic neuropathy, diabetic foot ulcer or intermittent claudication requiring acute treatment; 5. history or presence of vital organ primary diseases, including but not limited to neuropsychiatric, cardiovascular, digestive, respiratory, urinary, endocrine, blood, immune and other diseases, judged by researchers to be unsuitable for this study. 6. discontinuation of previous glucagon-like peptide-1 receptor agonist therapy due to safety/tolerability reasons or lack of efficacy reasons. 7. previous history of significant gastrointestinal disease (e.g. gastroesophageal reflux, gastric outlet obstruction, inflammatory bowel disease, active ulcers, etc.), or previous gastrointestinal surgery (except gastrointestinal polypectomy and appendectomy). 8. pregnancy, breast-feeding, intention of becoming pregnant during the trial; or women of childbearing potential (wocbp) or male subject not using adequate contraceptive measures.
non-invasive diagnosis of endometrial cancer

Conditions: Endometrial Cancer

Summary: the study aims to determine whether next generation sequencing and microsatellite analysis of cervical cytology is sensitive for the detection of endometrial carcinoma.

definitive diagnosis of endometrial cancer relies on endometrial biopsy, in addition to imaging. biopsy is however invasive and often painful, and its sensitivity in only moderate. cervical cytology could be an alternative. this is a proof-of-concept study. the investigators will carry out next generation sequencing of cervical cytology in patients with confirmed endometrial carcinoma, in order to determine whether activating variants are identified. about 15% of endometrial carcinomas are microsatellite instable (msi). the investigators will therefore also carry out msi analysis using msicare in the subset of cases with mmr-deficient cancer.

Eligibility criteria:
inclusion criteria: * endometrial cancer requiring hysterectomy * patient covered by french social security * patient capable of giving written informed consent exclusion criteria: - chemotherapy

Keywords: endometrial cancer next-generation sequencing screening microsatellite instability
impact of consumption of oats in lipid profile of children and adolescents with dyslipidemia

Conditions: Atherosclerosis; Hypercholesterolemia

Summary: atherosclerosis is the leading cause of death and disability in adults. however, investigations suggest that the basic pathology of heart disease as more severe myocardial infarction which usually reach mainly middle-aged or above, starts from childhood. hypercholesterolemia is one of the most important risk factors for atherosclerosis in adults and children, is associated with early deposition of lipids in the aorta and coronary arteries. among other recommendations for prevention and treatment of heart disease and risk factors, is the recommendation to encourage the intake of soluble fiber. the oats, a major source of soluble fiber, has been recognized as a potential component of the diet to lower blood cholesterol levels, this effect is attributed mainly to the beta-glucan, a type of soluble fiber present in large quantities in oats. in 1997 the food and drug administration admitted that the oat bran, oat flakes and oatmeal may have beneficial effects for health with the recommendation of daily intake of 3g of beta-glucan from oats and a food that brings a claim for promotion health, must provide, without enrichment, at least 1 gram of beta-glucan per serving. the objective of this project will be compared by randomized clinical trial, the impact of intake of oats, for 8 weeks in the lipid profile of children and adolescents with dyslipidemia. will be included in the study 120 volunteers aged between 5 and 16 years who are in nutritional monitoring for at least 1 month. the subjects will be randomly divided into 2 groups, with a control group and another intervention will receive 3 tablespoons of soup filled with oat bran, which corresponds to 3g of beta-glucan, along with breakfast, lunch and dinner. patients will be monitored with consultations on the 2nd, 4th and 8th weeks of treatment. blood sample will be performed, to obtain the lipid profile of patients, at the beginning and end of the study. to compare the groups are used student's t and squared chi. the alpha of 0.05 is considered critical. the program will be used statistical package for the social sciences (spss) version 15.0. it is expected a decrease in serum levels of total cholesterol and ldl-c. thus, living habits and healthy alternatives to prevent these risk factors should be done since childhood, especially in children who already have cholesterol levels of change.


Eligibility criteria:
inclusion criteria: * male/female * age limits 5 years-16 years

Keywords: oat cholesterol children adolescent level reduction of ceric cholesterol
"isis" study of sex differences in characteristics of adiposity and metabolism

Conditions: Obesity; Diabetes

Summary: the purpose of this study is to characterize differences in the structure and function of the body fat from two different parts of the body in young, healthy men and women. we will also compare how differences in metabolism relate to characteristics of body fat and its functions.

following screening, the study comprises of a total of 3 clinic visits (2 outpatient visits, and 1 overnight stay) completed during a 2 week period. for the outpatient visits, body composition (by dexa), visceral fat (by ct), ectopic fat (by mrs and ct) and aerobic fitness (by vo2max test) will be measured. women will also have ovarian parameters (follicle size and number) measured during the mr scans. following an overnight stay in the inpatient unit, insulin sensitivity (by euglycemic hyperinsulinemic clamp), interstitial lipolysis (by microdialysis), whole body lipolysis and glycolysis (by stable isotopes), abdominal adipose tissue oxygen content (hunt and direct methods) will be measured and a subcutaneous fat biopsy of the abdominal and gluteo-femoral tissue will be collected. women will complete all testing in the follicular phase of the menstrual cycle.

Eligibility criteria:
inclusion criteria: * diabetic men and women ages 40 to 60, inclusive and healthy men and women ages 20 to 35, inclusive. * body mass index (a ratio of height to weight) less than 25 kg/m2 (lean group) or 27 to 35 kg/m2 (overweight/obese group). * not involved in regular physical activity (more than 3 times per week). * women must have regular menstrual cycles (1 menstrual bleeding each month). exclusion criteria: * for men in the overweight/obese group, you have a waist circumference less than 102cm (40 inches). * you smoke. * you have liver, kidney, thyroid or heart diseases, or cancer. * you are claustrophobic. * you have metal objects in your body such as implanted rods or surgical clips. * if you are not diabetic and you are taking steroids, protease inhibitors, statins, antihypertensives or medications known to alter glucose or lipid metabolism. * if you are diabetic and you are taking steroids, protease inhibitors, or injectable antihyperglycemic medications (oral diabetic meds are allowed.) * if you are a woman, you are pregnant or breast feeding or trying to become pregnant (women who become pregnant throughout the study will be excluded). * if you are a woman, you are using hormonal contraceptives or have anovulation, androgen excess or irregular menstrual cycles (less than 1 cycle per month). * you have previously had a bmi \>35 kg/m2. * you are not able to eat the foods provided by pbrc. * if your weight has not been stable.
change of lung function after exercise in patients with chronic obstructive pulmonary disease

Conditions: Pulmonary Disease, Chronic Obstructive; Exercise; Lung Function Decreased; Quality of Life

Summary: the purpose of this study is to evaluate the changes of lung function before and after the exercise in patients with chronic obstructive pulmonary disease.the assessment of quality of life is also carried out through questionnaires.

this is a randomized,open-label study to research the changes of lung function before and after exercise in patients with chronic obstructive pulmonary disease .at baseline,lung function test,blood oxygen saturation and pulse are measured before and after 6-min walk test for each subject.quality of life is assessed through questionnaires including modified medical research council dyspnoea scale(mmrc),st george's respiratory questionnaire(sgrq),clinical chronic obstructive pulmonary questionnaire(ccq) and chronic obstructive pulmonary assessment test(cat).and then budesonide(160ug) and formoterol(4.5ug) bid will be given to the subjects for 3 months.the subjects will have a follow-up visit with all the examinations mentioned above after 3 months' treatment.

Eligibility criteria:
inclusion criteria: * male or female patients 18 to 80 years-old, inclusive. * a clinical diagnosis of chronic obstructive pulmonary disease according to the global initiative for chronic obstructive disease(gold 2018) guidelines. * post bronchodilator (following inhalation of salbutamol) forced expired volume in one second(fev1)/forced vital capacity(fvc) ratio ≤0.70. * willing and able to provide written informed consent. * willing and able to attend all study visits and adhere to all study assessments and procedures. exclusion criteria: * severe comorbidities including unstable cardiac or pulmonary disease or any other medical conditions including unstable ischemic heart disease,unstable cardiac arrhythmia or heart failure,life threatening arrhythmias,etc. * recent history of chronic obstructive pulmonary disease exacerbation requiring hospitalization or need for increased treatments for chronic obstructive pulmonary disease within 6 weeks.

Keywords: pulmonary disease, chronic obstructive exercise lung function quality of life
open label comparative study on celecoxib efficacy and safety vs non-selective nsaid in acute pain due to ankle sprain

Conditions: Ankle Sprain

Summary: to assess the efficacy of celecoxib loading dose of 400mg followed by 200 mg twice a day (bid) versus oral non-selective nsaids in acute pain due to ankle sprain.


Eligibility criteria:
inclusion criteria: * patients with first acute ankle sprain episode in the last six months classified as grade i or ii, confirmed by x-rays, according to the following definitions: * grade i: when the ligament is stretched but not torn and the anterior talofibular ligament is usually involved. the anterior draw test is negative. * grade ii: moderate sprains which usually result in partial tears af the ligaments, primarily the anterior talofibular and possibly the calcaneofibular ligament. ligamentous laxity may be present and there is moderate swelling. exclusion criteria: * patients who have a similar injury of the same joint within the last six months; or * clinical evidence of complete rupture of ankle ligaments (third degree sprain), or * requirements for bed rest, hospitalization, surgical intervention for the ankle injury; or * evidence of fractures; or non-removable full cast of any tipe; or * presence of bilateral occurrence of ankle injury or ipsilateral ankle and knee injury.

Keywords: ankle sprain, acute pain, nsaid, celecoxib,
prevalence of pulmonary embolism in patients with hemoptysis (popeihe)

Conditions: Hemoptysis; Pulmonary Embolism

Summary: estimation of the incidence of pulmonary embolism in patients presenting to the emergency department with hemoptysis.

multicenter prospective observational cross-sectional study with non-commercial (non-profit) objectives. the study population consists of consecutive patients who present to the emergency departments of the participating hospitals with hemoptysis. the diagnosis of pulmonary embolism will be made using the diagnostic algorithm suggested by the 2019 european guidelines. the pre-test clinical probability of pulmonary embolism will be defined based on the simplified wells score, which classifies pulmonary embolism as "likely" or "unlikely". in patients with a low pre-test clinical probability ("unlikely") and a d-dimer level below the threshold value (negative), the diagnosis of pulmonary embolism will be excluded, and further testing will not be necessary in this regard. the d-dimer level will be measured using the quantitative assay routinely used in each participating center; the threshold value for a positive result compared to a negative result is 500 μg per milliliter for patients under 50 years of age. for each additional decade of age, the exclusion cutoff will increase by 100 μg per milliliter. for patients with a high pre-test clinical probability ("likely"), a positive d-dimer test, or both, a pulmonary ct angiography will be the diagnostic test of choice. the criterion for the presence of pulmonary embolism is the detection of an intraluminal filling defect on ct.

Eligibility criteria:
inclusion criteria: * consecutive patients who present to the emergency department of the participating centers with hemoptysis * consent to participate. exclusion criteria: * pregnancy. * age below 18 years. * terminal illnesses with an estimated prognosis of less than 3 months.
trial assessing cooled radiofrequency denervation as a treatment for sacroiliac joint pain using the sinergy system

Conditions: Other Acute Pain; Chronic Pain

Summary: to evaluate the effectiveness of cooled radiotherapy denervation of the sacroiliac region using the sinergy system by comparing a treatment group to a placebo group


Eligibility criteria:
inclusion criteria: * predominantly axial pain below l5 vertebrae * greater than 75%pain relief from 2 seperate lateral branch blocks done on different days * chronic axial pain lasting longer than 6 months, 3 day average vas between 4 and 8 * age greater than 18 * failed to acheive adequate improvemnet with comprehensive non-operative treatments, includingbut not limited to: activity alteration, non0steriodal anti-iflammatory, physical and/or manual therap, and flurpscopically guided steriod injections in and around the area of pathology * all other possible sources oflow back pain have been ruled out, including but not limited to the intervertebral discs, bone fracture. exclusion criteria: * beck depression greater than 20% * irreversible psychological barriers to recovery * spinal pathology that may impede recovery such as spins bifida occulta, * moderate to severe foraminal or central canal stenosis * systemic infection or localized infection at inducer site * concomitant cervical or thoracic pain greater than 2/10 on vas * uncontrolled or acute disease * chronic severe condition such as rheumatoid arthritis * preganancy * active radicular pain * immunosuppression * workers compensation * allergy to injectants or medications used in procedure * high narcotis use greater than 30 mg hydrocodone or equivalent * smokers * body mass index greater than 29.9
the impact of intravenous vitamin c combined with nerve blocks on postoperative pain and recovery after total knee arthroplasty

Conditions: Ascorbic Acid; Postoperative Pain

Summary: the aim of this prospective randomized-control study was to evaluate the impact of a single high-dose intravenous vitamin c added to ultrasound-guided blocks at induction on postoperative pain, sngception and early functional rehabilitation of the knee joint in patients under-going total knee arthroplasty.


Eligibility criteria:
inclusion criteria: 1. physical status according to american society of anesthesiologists (asa) i-iii 2. patients scheduled for total knee arthroplasty 3. age ranging from 50 to 80 years old exclusion criteria: 1. previous operation on the same knee 2. allergy or intolerance to one of the study medications 3. coagulopathy 4. having lower limbs neuropathy 5. end-organ failure (ckd stage v or vi, nyha iii or iv) 6. bmi \> 35 7. chronic opioid use or drug abuser 8. difficulty in communication (impaired mental status) 9. hyperuricemia or glucose-6-phosphate dehydrogenase deficiency patient

Keywords: ascorbic acid total knee arthroplasty regional analgesia