Kornimate/medical-research-clean huggingface dataset:
effects of exercise prediabetic individuals

Conditions: Prediabetes / Type 2 Diabetes

Summary: the aim of this study was to determine the effects of two different exercise protocols on body composition, aerobic capacity, blood lipid profile, some biomarkers, quality of life and exercise beliefs in participants at risk of diabetes.

after being informed about the study and possible risks, all participants who gave written informed consent and met the eligibility requirements will be randomly assigned to 2 separate groups.

Eligibility criteria:
inclusion criteria: * being between 18-60 years old * hba1c value between 5.7%-6.4% * bmi\>24,9 kg/m² * being sedentary * not on any diet exclusion criteria: * insulin and derivative drug use * uncontrolled hypertension * history of heart disease * history of mi or stroke

Keywords: exercise anti-inflammatory markers aerobic capacity
progressing ankle brace restriction on walking and running gait characteristics in healthy individuals

Conditions: Ankle Sprains

Summary: a convenience sample of 20 participants, 18 years or older healthy individuals were recruited. participants were excluded if they report being pregnant or being treated for a musculoskeletal injury. after explanation of the study and consent were obtained, each participant completed background information and the cumberland ankle instability tool (cait). participants began by completing a 1 minute, 3mph walking gait assessment while unbraced, followed by a 2-minute, 6mph unbraced running assessment. following the unbraced condition participants were randomly assigned into 1 of 4 conditions: \[1\] active ankle 329 ankle sleeve, \[2\] as1pro, \[3\] eclipse 1, or \[4\] eclipse 2. participants placed an assigned brace on each ankle and then repeated the walking gait and running assessments. after this test the participants filled out a 10-item satisfaction questionnaire, and then were randomly assigned a second brace. the protocol was repeated until they have completed the walking, running, and satisfaction survey in all 4 brace conditions.

a convenience sample of 20 participants, 18 years or older healthy individuals were recruited. participants were excluded if they report being pregnant or being treated for a musculoskeletal injury. after explanation of the study and consent were obtained, each participant completed background information and the cumberland ankle instability tool (cait). participants began by completing a 1 minute, 3mph walking gait assessment while unbraced, followed by a 2-minute, 6mph unbraced running assessment. following the unbraced condition participants were randomly assigned into 1 of 4 conditions: \[1\] active ankle 329 ankle sleeve, \[2\] as1pro, \[3\] eclipse 1, or \[4\] eclipse 2. participants placed an assigned brace on each ankle and then repeated the walking gait and running assessments. after this test the participants filled out a 10-item satisfaction questionnaire, and then were randomly assigned a second brace. the protocol was repeated until they have completed the walking, running, and satisfaction survey in all 4 brace conditions.

Eligibility criteria:
inclusion criteria: * healthy individuals who are able to run for 10 minutes total exclusion criteria: * pregnancy, lower body injury

Keywords: ankle biomechanics
tidal irrigation versus intra-articular steroid injection in the treatment of knee osteoarthritis

Conditions: Knee Osteoarthritis

Summary: previous studies have indicated that patient expectations, beliefs and preferences may have an impact on treatment outcomes. the kivis study was primarily designed to compare two effective treatments for knee osteoarthritis (tidal irrigation (medical washout of the knee) or intra-articular corticosteroid injection). at study entry any preference expressed by the patient for each of the treatment interventions was recorded. this study assessed the effects of two treatments given at a single time-point and hence the effects of patient preference could be assessed independently of any compliance issues.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of knee oa * knee pain for most days of the prior month * radiographic evidence consistent with knee oa * aged between 40 and 90 years old exclusion criteria: * symptomatic hip oa * co-existent inflammatory or crystal arthritis * prior knee surgery * injury to the knee in the preceding 6 months * any intra-articular injection in the preceding 3 months * inability to provide informed consent
#kindgirlsinaction: a programme for the promotion of mental health of female adolescents

Conditions: Quality of Life; Eating Disorders; Eating Behavior; Psychological; Emotion Regulation; Body Image; Relations, Interpersonal

Summary: the #kindgirlsinaction project started in 2017 and developed and implemented a psychotherapeutic intervention program in portuguese female adolescents. this program aimed to improve the overall quality of life and well-being of the participants, and specifically to promote a qualitative improvement in body image and interpersonal relationships, through the promotion of self-compassion, compassion and psychological flexibility. #kindgirlsinaction is a school-based program, with 9 sessions over 9 weeks. it is essentially practical and interactive, with exercises created specifically for the program, as well as the regular practice of mindfulness.


Eligibility criteria:
inclusion criteria: * being a female adolescent; * being aged between 12 and 18; * being a part of a classroome with immediate availability to attend the sessions. exclusion criteria: * having a clinical condition that could compromise the completion of self-report questionnaires; * having a significant score on screening measures administered pre-intervention.

Keywords: intervention programme school-based adolescence girls psychological well-being compassion psychological flexibility positive body image
exercise intolerance in renal failure

Conditions: Kidney Failure, Chronic

Summary: patients with chronic kidney disease have profound exercise intolerance which contributes to an increased risk of cardiovascular disease. the investigators have found that chronic kidney disease patients have an exaggerated increase in blood pressure during certain forms of exercise that could certainly contribute to exercise dysfunction as well as cardiovascular risk. the investigators will test the mechanisms underlying this exaggerated blood pressure response, as well as the potential benefits of short-term tetrahydrobiopterin (bh4) with folic acid on both exercise dysfunction and cardiovascular risk factors in chronic kidney disease. the investigators will test whether short-term treatment with tetrahydrobiopterin (bh4), a cofactor for nitric oxide, together with folic acid improves inflammation, vascular health, and adrenaline levels, both at rest and during exercise in chronic kidney disease.


Eligibility criteria:
inclusion criteria: * chronic kidney disease (ckd) stages i, ii, and iii and do not regularly exercise 1. ckd stages i, ii, and iii will be defined as reduction in estimated glomerular filtration rate (egfr) to 30-59 cc/minute as calculated by the modification of diet in renal disease (mdrd) equation, or an egfr\>60 cc/minute with proteinuria greater than 500 mg/g of creatinine or 500 mg per 24 hours. * willing and able to cooperate with the protocol * ckd patients must have stable renal function (no greater than a 20% reduction in egfr over the prior 3 months) * controls will be matched for age, gender, race, and hypertensive status. exclusion criteria: * severe ckd (egfr\<30 cc/minute) * drug or alcohol abuse * diabetes * any serious systemic disease that might influence survival * severe anemia with hgb level \<10 g/dl * clinical evidence of congestive heart failure or ejection fraction below 35% * any history of past myocardial infarction or cerebrovascular accident * symptomatic heart disease determined by electrocardiogram, stress test, and/or history * treatment with central alpha agonists * uncontrolled hypertension with bp greater than 160/90 mm hg * low blood pressure with bp less than 110/60 * history of nephrolithiasis * pregnancy or plans to become pregnant * treatment with vitamin c within the past 3 months * hepatic enzyme concentrations greater than 2 times the upper limit of normal * hiv infection * surgery within the past 3 months * previous treatment with bh4 * known hypersensitivity to bh4 * any condition that places the participant at high risk of poor adherence or poor follow-up * patients must be willing to use an acceptable method of contraception if of childbearing age
a study of extended use of recombinant human parathyroid hormone (rhpth(1-84)) in hypoparathyroidism

Conditions: Chronic Hypoparathyroidism; Hypoparathyroidism

Summary: chronic hypoparathyroidism is a life-long and irreversible disease for which the chronic administration of rhpth(1-84) is a potential treatment option. the group of participants in the aaae0544 core study has been taking rhpth(1-84) for the treatment of hypoparathyroidism for up to 11 years. this study is designed to extend this experience and gain knowledge about how safe and effective rhpth(1-84) is in participants with hypoparathyroidism over a long-term duration.


Eligibility criteria:
inclusion criteria * participants that are currently or previously enrolled in the core study (aaae0544 \[nct01199614\]) and have maintained uninterrupted therapy with recombinant human parathyroid hormone (rhpth(1-84)) (transient interruptions of up to 1 month continuously off treatment may be allowed). * signed and dated informed consent form (icf). * adult men and women 18 to 85 years of age. * history of hypoparathyroidism for at least 12 months prior to rhpth(1-84) treatment, defined by the requirement for supplemental calcium and/or active vitamin d to maintain serum calcium along with an undetectable or insufficient parathyroid hormone (pth) concentration. * able to perform daily subcutaneous (sc) self-injections of study medication (or have designee perform injection). * willingness and ability to understand and comply with the protocol. women must agree to pregnancy testing and acceptable methods of contraception, as detailed in the protocol. exclusion criteria * the participant is treated or has been treated with any investigational drug, aside from rhpth(1-84), within 30 days of consent. * as assessed by the investigator, the participant has any safety or medical issues that contraindicate participation in the study. * the participant and/or the participant's parent(s) or legally-authorized representative(s) are unable to understand the nature, scope, and possible consequences of the study. * the participant is unable to comply with the protocol, example, uncooperative with protocol schedule, refusal to agree to all of the study procedures, inability to return for evaluations, or is otherwise unlikely to complete the study, as determined by the investigator or the medical monitor. * the participant is pregnant or lactating. * participants who are at increased baseline risk for osteosarcoma such as participant with paget's disease of bone or unexplained new elevations of alkaline phosphatase, participants with hereditary disorders predisposing to osteosarcoma or participants with a prior history of external beam or implant radiation therapy involving the skeleton.
randomized, double-blind, placebo-controlled study to evaluate safety & efficacy of sarecycline in treatment of acne

Conditions: Acne Vulgaris

Summary: to evaluate the efficacy and safety of an approximate 1.5 mg/kg/day dose of oral sarecycline compared to placebo in the treatment of moderate to severe facial acne vulgaris


Eligibility criteria:
inclusion criteria: * signed informed consent or assent form * male/female, 9 to 45 years of age, inclusive * body weight between 33 and 136 kg, inclusive * facial acne vulgaris with: * 20-50 inflammatory lesions (papules, pustules and nodules) * 30-100 noninflammatory lesions (open and closed comedones) * no more than 2 nodules * investigator's global assessment (iga) score of moderate (3) or severe (4) * negative urine pregnancy test at baseline - females of childbearing potential * agrees to use an effective method of contraception throughout the study * refrain from use of any other acne medications and medicated cleansers, and avoid excessive sun exposure and tanning booths for duration of study * able to fulfill the requirements of protocol, indicated willingness to participate in the study and agrees to all study procedures (including mandatory photography) by providing written informed consent/assent and an authorization to disclose protected health information (phi). exclusion criteria: * has a dermatological condition of the face that could interfere with the clinical evaluations * has a history of any of the following: * allergy to tetracycline-class antibiotics or to any ingredient in the study drug * pseudomembranous colitis or antibiotic-associated colitis * treated for any type of cancer within the last 6 months * has known resistance to other tetracyclines * has receive any of the following treatments within 12 weeks of screening: * systemic retinoids * systemic corticosteroids * androgens/anti-androgenic therapy (eg, anabolic steroids, spironolactone) * non-medicated procedures for the treatment of acne (eg, laser, light or thermaclear) * has used any acne affecting treatment without an appropriate washout period * has initiated hormonal contraceptive use within 12 weeks prior to screening or plans to initiate or switch hormonal contraceptive products during the study period * is pregnant, lactating or planning a pregnancy during the study period * has any other disorder causing hyperandrogenism including, but not limited to polycystic ovary syndrome, adrenal or ovarian tumors, cushings disease or congenital adrenal hyperplasia * has drug-induced acne * has significant intercurrent illness, psychiatric disposition or other factors that, in the opinion of the investigator or medical monitor, precludes participation in the study * is currently participating, or has participated within 30 days prior to the screening period in an investigational drug or device study * has previously participated in any clinical trial involving the use of sarecycline * is judged by the investigator to be unsuitable for any reason.

Keywords: acne
social media based peer-led intervention for hiv prevention

Conditions: HIV Prevention; PrEP Uptake

Summary: the purpose of this study is to test the feasibility, acceptability, and preliminary efficacy of e-prep on reaching young men of color who have sex with men (ymcsm) at high-risk of hiv infection to reduce hiv acquisition. e-prep is a peer-designed social media-based health intervention to increase prep awareness, knowledge, and motivation as a tool for hiv prevention and to increase linkage to primary care.

this study examines a social media based peer-led and delivered intervention focused on increasing prep adoption in young men of color who have sex with men (ymcsm). while prior efficacy trials have included ymcsm 18-29, we will focus on prep in ymcsm outside clinical trial settings. rather than an alternative medium for implementation of existing interventions designed for in-person contact, social media may be a true 'game changer' to engage hard to reach individuals. while many online behavioral interventions exist, including some that use social media, this will be one of the few studies to use and test social media to facilitate uptake of a biomedical intervention. e-prep will connect the target population (ymcsm) to a new prevention tool (prep) through rapid linkage to medical care, accelerating diffusion of prep. given the paucity of data regarding social media-based interventions to change health-related behavior, e-prep may have a marked impact on future bio-behavioral interventions, especially those that include diffusion of innovation. social media offers the power of scale and efficiency for large potential impact, even with relatively low-intensity interventions. similarly, prep, if widely adopted in high-risk populations and offered with behavioral interventions, could markedly decrease hiv infection rates. social media-based, peer-led approaches like e-prep could be used to enhance efforts by community-based and other organizations that employ internet-assisted or peer-outreach strategies to improve health. primary aim: to test the feasibility and preliminary efficacy of e-prep for increasing prep adoption in a cluster-randomized controlled trial.

Eligibility criteria:
inclusion criteria: * male or transgender individual; ages 18-29; have had unprotected anal sex with a male partner in the prior 12 months; fluent in english or spanish; are hiv-negative or unknown status (self-report); identify as black and/or latino exclusion criteria: * ymcsm who do not consent/assent to study; not currently using at least one of 2 social media sites that will be used for the e-prep intervention (not using facebook, or instagram), and do not live in new york city.

Keywords: prep hiv prevention public health social media campaign peer intervention
a study of abemaciclib (ly2835219) with abiraterone in men with prostate cancer that has spread to other parts of the body and is expected to respond to hormonal treatment (metastatic hormone-sensitive prostate cancer)

Conditions: Prostatic Neoplasms; Neoplasm Metastasis; Urogenital Neoplasms; Physiological Effects of Drugs; Antineoplastic Agents; Antineoplastic Agents, Hormonal; Androgens; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Abiraterone Acetate; Steroid Synthesis Inhibitors; Cytochrome P-450; Enzyme Inhibitors; Prednisone; Prednisolone; Cyclin-Dependent Kinase 4; Cyclin-Dependent Kinase 6

Summary: the purpose of this study is to learn whether adding abemaciclib to abiraterone plus prednisone prolongs the time before prostate cancer gets worse. participation may last approximately 60 months.


Eligibility criteria:
inclusion criteria: * adenocarcinoma of the prostate (as the predominant histology) * high-risk metastatic hormone-sensitive prostate cancer. high risk is defined as: * greater than or equal to (≥)4 bone metastases by bone scan and/or * ≥1 visceral metastases by computed tomography or magnetic resonance imaging * must have initiated androgen deprivation therapy (adt) with luteinizing hormone-releasing hormone (lhrh) agonist/antagonist or bilateral orchiectomy prior to randomization. up to 3 months of adt prior to randomization is permitted with or without first-generation anti-androgen. * adequate organ function * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * prior treatment with abemaciclib or any other cyclin dependent kinase 4 and 6 (cdk4 \& 6) inhibitor * development of metastatic prostate cancer in the context of castrate levels of testosterone * received any prior systemic therapy for metastatic prostate cancer (including investigational agents), except for adt and first-generation anti-androgen * clinically significant cardiovascular disease as evidenced by myocardial infarction, arterial thrombotic events, or severe/unstable angina in the past 6 months, or new york heart association class ii to iv heart failure * history of syncope of cardiovascular etiology, ventricular arrhythmia of pathological origin, or sudden cardiac arrest. chronic and hemodynamically stable atrial arrhythmia well-controlled on medical therapy is permitted * uncontrolled hypertension * clinically active or chronic liver disease, moderate/severe hepatic impairment * known untreated central nervous system (cns) metastasis. participants with a history of treated brain metastases are eligible if stable for at least 8 weeks prior to randomization and off corticosteroid for at least 2 weeks prior to randomization

Keywords: metastatic hormone sensitive prostate cancer mhspc stage iv prostate cancer recurrent prostate cancer de novo metastatic prostate cancer high-risk visceral metastasis cyclin-dependent kinase 4 (cdk4) cyclin-dependent kinase 6 (cdk6) cdk4 cdk6 cdk4/6
trial on the efficacy and safety of two different glucocorticoid dose regimens in allergic bronchopulmonary aspergillosis

Conditions: Allergic Bronchopulmonary Aspergillosis

Summary: allergic bronchopulmonary aspergillosis (abpa) is a pulmonary disorder caused by a complex hypersensitivity response to antigens released by the fungus aspergillus fumigatus. oral corticosteroids are currently the treatment of choice for abpa associated with bronchial asthma. they not only suppress the immune hyperfunction but are also anti-inflammatory. however, there is no data to guide the dose and duration of glucocorticoids and different regimens of glucocorticoids have been used in literature. the disorder is highly prevalent in india. the investigators have previously reported their experience with screening stable outpatients with bronchial asthma and acute severe asthma for abpa. the investigators have also recently reported the prognostic factors associated with clinical outcomes in patients with abpa. the aim of this prospective randomized controlled trial (rct) is to evaluate the efficacy and safety of two different glucocorticoid dose protocols in patients with abpa.


Eligibility criteria:
inclusion criteria: * diagnosis of abpa * presence of all the following three criteria: 1. immediate cutaneous hyperreactivity on aspergillus skin test 2. elevated total ige levels \> 1000 iu/ml 3. a fumigatus specific ige levels \> 0.35 ku/l, and, * presence of two of the following criteria: 1. presence of serum precipitating antibodies against a fumigatus 2. fixed or transient radiographic pulmonary opacities 3. absolute eosinophil count \> 1000/µl 4. central bronchiectasis on hrct exclusion criteria: * if they have taken glucocorticoids for more than three weeks in the preceding six months * failure to give informed consent * enrollment in another trial of abpa

Keywords: bronchial asthma allergic bronchopulmonary aspergillosis