Kornimate/medical-research-clean huggingface dataset:
safety and pharmacokinetics of oral islatravir (mk-8591) once monthly in participants at low risk of human immunodeficiency virus 1 (hiv-1) infection (mk-8591-016)

Conditions: HIV-1 Infection

Summary: this study will evaluate the safety, tolerability and pharmacokinetics (pk) of 6 once-monthly doses of oral islatravir (60 mg and 120 mg) compared with placebo in adults at low risk of hiv-1 infection

this study is ongoing for collection of safety follow-up of infants born to mothers participating in the study. the present results are based on the week 68 interim analysis.

Eligibility criteria:
inclusion criteria: * is in general good health with acceptable laboratory values at screening * is confirmed hiv-uninfected based on negative hiv-1/hiv-2 test result before randomization * has low risk of hiv infection, within 12 months prior to screening visit or the rescreening visit (if applicable) * use contraceptives consistent with local regulations * female is not pregnant or breastfeeding, and is not a woman of childbearing potential (wocbp) * a wocbp is using an acceptable contraceptive method, or is abstinent from heterosexual intercourse as their preferred and usual lifestyle; or has a negative pregnancy test. exclusion criteria: * has hypersensitivity or other contraindication to any of the components of the study interventions as determined by the investigator * has an active diagnosis of hepatitis due to any cause * has a history of malignancy ≤5 years prior to signing informed consent except for adequately treated basal cell or squamous cell skin cancer or in situ cervical cancer. * is taking or is anticipated to require systemic immunosuppressive therapy, immune modulators, or any prohibited therapies from 30 days prior to day 1 through the duration of the study. * is currently participating in or has participated in an interventional clinical study with an investigational compound or device within 30 days prior to day1 through the duration of the study. * has previously been randomized in a study and received islatravir (mk-8591). * female is expecting to conceive or donate eggs at any time during the study * has qtc interval (using fridericia correction) \>450 msec (for males) or \>460 msec (for females) or deemed clinically abnormal by the investigator.
aortic stiffness in patients with genetic aortopathies

Conditions: Rare Diseases; Aortic Stiffness; Connective Tissue Defect

Summary: the goal of this observational study is to study arterial stiffness in patients with thoracic ascending aortic aneurysms (taa), either syndromic or non-syndromic. the main questions it aims to answer are: * stratification of aortic risk based on arterial stiffness; compare measurements with morphological and haemodynamic features of the ascending thoracic aorta. participants will be asked to undergo non-invasive evaluation of blood pressure and arterial stiffness.

recent studies have highlighted the role played by the aorta and the great arteries in the regulation of the blood pressure (bp) and peripheral blood flow. similarly, the structural and functional alteration of the aortic wall having a genetic cause is highly associated with the onset of aneurysms, especially of the ascending aorta, for which it is essential to monitor the aortic stiffness, which is detectable through a non-invasive and non-radioactive method such as pulse wave velocity (pwv). despite literature studies correlating pwv in mfs, few evaluations of aortic stiffness in patients with syndromic taa have been done and its potential correlations with other aneurysm markers.

Eligibility criteria:
inclusion criteria: * subjects with aat, either syndromic or non syndromic; * signed informed consent exclusion criteria: * patients with early menopause and/or osteoporosis, rheumatic heart disease and active malignant tumours; * patients with acute and chronic inflammatory conditions such as: chronic liver disease, chronic renal insufficiency and diseases affecting the thyroid system; * seropositivity to hiv, hcv, hbsag and sars-cov-2; * pregnancy

Keywords: arterial stiffness ascending aortic aneurysm pulse wave velocity
mechanical properties of peripheral and accessory respiratory muscles in chronic obstructive pulmonary disease patients

Conditions: COPD

Summary: the biomechanical properties of accessory respiratory muscles and peripheral muscles of copd and healthy subjects will be measured and compared with the myotonpro device.


Eligibility criteria:
inclusion criteria: * being diagnosed with group c and d copd according to gold staging * having been using the same medications for the last 4 weeks * no additional comorbid diseases of the orthopedic, neurological or cardiac system exclusion criteria: * presence of another respiratory system disease other than copd * patients who have had an acute copd exacerbation in the last 4 weeks * patients experiencing copd exacerbations during the study protocol * presence of fatty tissue at the measurement points, which may impair the measurement quality. * have already participated in another clinical trial within the last 30 days that may affect the results of the study. inclusion criteria for healthy cases * being over 18 years of age * not having any diagnosed chronic disease * not being a smoker
impact of combined oral contraceptive pills on migraine

Conditions: Migraine

Summary: the investigators will assess the effect of combined oral contraceptive pills (cocs) on migraine features and treatment response to allow better interpretation of the exact consequence of hormonal contraceptive use on migraineurs.

the investigators will use a questionnaire to detect the migraineur demographic and clinical features (disease duration, attack frequency and duration, pain intensity assessed by visual analogic scale, hit score in female patients on regular cocs * special emphasis was put on clinical phenotype (for example, the character of pain, location, associated symptoms, etc.); vascular risk factors (hypertension, diabetes, smoking); history of cerebrovascular events and other conditions (collagen disorders, hepatic disorders, blood diseases, heart, kidneys), and family history. * all the patients will undergo clinical neurological and general physical examinations, and migraine history and associated phenotypic features will be established.

Eligibility criteria:
inclusion criteria: * female migraine patients on cocs or mechanical contraceptive methods, according to the international classification of headache disorders 3rd edition, aged 18-55 years exclusion criteria: 1. patients with major neurological conditions such as (epilepsy, ischemic or hemorrhagic stroke, multiple sclerosis, mitochondrial diseases, and brain tumors). 2. pregnant, lactating, and menopausal patients. 3. patients with any contraindications to ibuprofen or propranolol.

Keywords: migraine combined oral contraception egypt
nutrition insights day asia

Conditions: Nutritional Status; Malnutrition; Caloric Deficit; Protein Deficiency

Summary: this is an observational, cross-sectional study to be conducted on the nutrition insights day (nid), with retrospective review of patient medical charts. no prospective follow-up period is considered. this study aims to obtain a contemporary overview of the nutritional status, the use of en and/or pn and the provision of calories and proteins in patients after major elective gastrointestinal surgery with existing malnutrition or at risk of hospital malnutrition in selected asian countries.


Eligibility criteria:
inclusion criteria: 1. adult patients after elective major abdominal gastrointestinal surgery \[i.e. elective major gi resections, partial or total, especially for cancer, including: esophagectomy, gastrectomy, enterectomy (small bowel resection), colectomy, hepatectomy, pancreatectomy, resections for gall bladder or bile duct cancer (cholangiocarcinoma)\] with pre-existing malnutrition or who are at significant risk for malnutrition or nutrition-related complications\*, with indications for nutritional support 2. hospitalization on sicu or major surgical ward on the nid 3. use of en (nutritional intake provided via tube feeding) and/or pn for at least one day before the nid 4. if patient received oral nutrition (on) or oral nutrition supplements (ons) during the observational phase from day -5 to day -2, complete and reliable data of daily caloric and protein intake is available 5. latest surgical intervention ≤ 10 days before nid exclusion criteria: 1. patients with burn injuries 2. patients requiring postsurgical mechanical ventilation and sedation on the nid 3. patients receiving on and/or ons at any quantity on the day before the nid 4. patients requiring emergency procedures

Keywords: nutritional status malnutrition energy intake protein intake icu surgical ward hospital enteral nutrition parenteral nutrition nutrition
the feelings club: evaluating a school-based intervention for children at risk for depression and anxiety disorders

Conditions: Anxiety; Depression

Summary: anxiety and mood disorders are among the most prevalent mental health problems in childhood. they have severe long-term morbidity, and associated academic and social impairment. building on the investigators' experience with outcome evaluation in clinically anxious or depressed children, they propose to evaluate within the school system a cognitive behavioral therapy (cbt) intervention for children in grades 3 to 6 with elevated symptoms of anxiety or depression on standardized questionnaires. the participant's outcomes will be compared with those of similar children randomly assigned to an activity control group. hypothesis 1a): children in the intervention condition will show greater symptom reduction relative to children in the control condition (primary outcome: anxiety symptoms). hypothesis 1b): children in the intervention condition will show fewer symptoms during follow-up relative to children in the control condition. hypothesis 2: children with anxious or depressive symptoms treated in the school setting using cbt have a lower risk of developing internalizing disorders within 1 year of treatment than children in a control condition. hypothesis 3: self-esteem, anxiety and depression-related impairment, and academic functioning will improve more in intervention participants than in controls. hypothesis 4: school characteristics, child age, and attitudes of participating personnel are predictive of treatment response.


Eligibility criteria:
inclusion criteria: * children with t-score elevations \> 60 on either the total score or at least 4 subscales of either instrument will be considered eligible for the study. exclusion criteria: * children will be excluded if they already meet criteria for disorders on the anxiety disorders interview schedule (adis), are unable to complete the inventories due to intellectual impairment or weak english skills (limiting the benefits of cognitive behavioral therapy), or if they are already engaged in ongoing psychiatric or psychological treatment that could confound study intervention effects. * children with elevated 'externalizing' scores on the child behavior checklist (cbcl) (t-score \> 60) will also be excluded, as they are often difficult to manage in cbt groups, and may obtain more benefit from other interventions.
effect of androgen suppression on bone loss in patients with or without bone metastases secondary to prostate cancer

Conditions: Osteoporosis; Prostate Cancer

Summary: rationale: assessing the effect of androgen suppression on bone loss in prostate cancer patients may improve the ability to plan treatment, may decrease the risk of fractures and bony pain, and may help patients live more comfortably. purpose: clinical trial to determine the effect of androgen suppression on bone loss in patients who have prostate cancer.

objectives: * evaluate the effect of androgen ablation on bone resorption in patients with or without bone metastases secondary to prostate cancer. outline: patients are stratified according to prior androgen ablation therapy (yes vs no) and metastatic disease (yes vs no). patients undergo blood work and 24 hour urine collection on day 1 and at week 6-8. patients who have received androgen ablation therapy and are found to have increased bone resorption undergo a dual energy x-ray absorptiometry (dexa) scan. a comparison is made between androgen ablation therapy and bone resorption and if metastases are associated with the two. projected accrual: a total of 150 patients will be accrued for this study within 9 months.

Eligibility criteria:
disease characteristics: * histologically confirmed prostate cancer * stratum 1 (androgen ablation therapy): * bone metastases * prior orchiectomy allowed * prior or concurrent leuprolide and/or goserelin therapy allowed * stratum 2 (androgen ablation therapy): * no bone metastases * prior orchiectomy allowed * prior or concurrent leuprolide and/or goserelin therapy allowed * stratum 3 (no androgen ablation therapy): * no metastatic disease * prior flutamide or bicalutamide therapy allowed patient characteristics: age: * not specified performance status: * not specified life expectancy: * not specified hematopoietic: * calcium normal hepatic: * not specified renal: * not specified prior concurrent therapy: biologic therapy: * not specified chemotherapy: * see disease characteristics endocrine therapy: * see disease characteristics * no concurrent high dose steroids radiotherapy: * prior radiotherapy allowed surgery: * see disease characteristics * prior radical prostatectomy allowed other: * no concurrent bisphosphonates

Keywords: stage i prostate cancer stage iib prostate cancer stage iia prostate cancer stage iii prostate cancer stage iv prostate cancer osteoporosis
teli com - telithromycin in children with otitis media

Conditions: Otitis Media, Suppurative; Otitis Media, Purulent

Summary: this is a multinational, randomized (1:1), double-blind, double-dummy, comparative, 2- treatmentgroup study in children (age range: ≥6 months and \<72 months \[\< 6 years of age\]) with aom.subjects will be randomized to receive either telithromycin (50 mg/ml) oral suspension 25 mg/kgonce daily for 5 days or azithromycin (40 mg/ml) oral suspension (10 mg/kg once on day 1, followed by 5 mg/kg once daily on days 2-5, not to exceed 500 mg onday 1 and 250 mg/day from days 2 - 5. matching placebo suspensions for telithromycin and azithromycin will also be dispensed to provide blinding for the different treatment regimens.assessments and reporting of safety will be carried out at all visits.


Eligibility criteria:
inclusion criteria: subjects meeting all of the following criteria will be considered for enrollment into the study: * subjects ≥6 months and \<72 months (\< 6 years) of age; * recent (within the last 72 hours) and rapid onset of aom symptoms and signs; * the presence of mef on otoscopy indicated by a bulging tympanic membrane; * otalgia or ear tugging or touching within the last 24 hours that interferes with or precludes normal activity or sleep; * at least 1 of the following clinical findings not specific to aom: fever, vomiting, diarrhea, anorexia, sleep disturbance, or irritability; * caregiver-reported aom symptoms sufficient for entry according to protocol criteria. * caregiver-reported aom symptoms diary * tympanometry exhibiting: * type b curve or positive pressure peak curves. exclusion criteria: subjects presenting with any of the following will not be included in the study: * uncertain diagnosis of aom or mild to moderate symptoms and signs of aom that would make the subject a candidate for observation and analgesic therapy with observation for 2-3 days. * otorrhea or tympanostomy tube present in the ear to be evaluated; * otitis externa; * down syndrome, cleft palate, craniofacial disorders, cystic fibrosis/mucoviscidosis, immotile cilia syndrome, congenital immunodeficiency or acquired immunodeficiency syndrome with \<25% cd4 count or requiring prophylaxis for pneumocystis jiroveci (carinii) or requiring treatment for an opportunistic infection; * known congenital long qt syndrome; * known or suspected uncorrected hypokalemia (≤3 mmol/l \[meq/l\]), hypomagnesemia, bradycardia (\<50 bpm); * myasthenia gravis; * known impaired renal function, as shown by creatinine clearance ≤25 ml/min; * history of hypersensitivity or intolerance to macrolides or azithromycin; * previous enrollment in this study or previous treatment with telithromycin; * children of the investigator or subinvestigator, research assistant, pharmacist, study coordinator, other staff, or relative thereof directly involved in the conduct of the protocol.

Keywords: otitis media suppurative purulent ketolide azithromycin telithromycin controlled clinical trials
the effect of exercise training and arch supported insoles on balance and vertical jump performance in football players with foot pronation deformity

Conditions: Foot; Pronation, Congenital

Summary: this study aims to investigate the effects of foot pronation exercises and arch support insoles on balance and vertical jump test in football players.

the study took place in footbalance turkey, which works on foot analysis and insoles. 30 professional football players with pronation who divided into two groups. the football players in the experimental group used insoles and also participated the foot core exercise program twice a week for 4 weeks duration. the football players in the control group just used the insoles.we used the footbalance assessmnet system for insoles. navicular drop test, y balance test, flamingo testand vertical jump test applied to evalute foot pronation, dynamic balance, static balance and jump performace respectively.

Eligibility criteria:
inclusion criteria: 1. voluntary participation in research 2. to be between the ages of 18-45 3. overpronation foot ( navicular drop test over 10 mm and footbalance device with visual display) 4. professional football players at least 5 years exclusion criteria: 1. history of surgery for musculoskeletal structures in both lower extremities 2. history of fracture in both lower extremities 3. acute injury of the musculoskeletal structures of other joints of the lower extremity affecting joint function and integrity in the last 3 months 4. have any other knee pathology 5. balance or vestibular disorder

Keywords: foot pronation insoles footcore exercises
oral care of intubated intensive care patient

Conditions: Pneumonia; Mechanical Ventilation Complication; Salivation; Dry Mouth

Summary: the aim of the research was to examine the effect of oral care bundle application on oral health, salivary ph (power of hydrogen), dry mouth and ventilator associated pneumonia in intubated patients compared to standard oral care.

maintaining the integrity of the oral mucosa in intensive care unit patients is very important due to its close relationship with systemic health, disease risk and self-image, as well as comfort and nutrition. serious problems develop in patients who have no or insufficient saliva movement or production, are unconscious, or have an artificial airway. oral health problems, which begin with the deterioration of the saliva flow and content of intubated patients, lead to much more risky and costly situations that end in ventilator associated pneumonia. in the literature, it is seen that oral care practices performed in accordance with protocols increase the risk of complications and that bundle care practices used in different care areas increase the performance of care.in this randomized controlled study, people who were aged between 18 and 70, had received mechanical ventilation support, were intubated orally and in the first 24 hours of intubation, and had a stable hemodynamic status were included in the study.

Eligibility criteria:
inclusion criteria: * mechanical ventilation support, * orally intubation * in the first 24 hours of intubation, * stable hemodynamic status exclusion criteria: * pneumonia * sjögren's syndrome, * radiotherapy and/or chemotherapy, * oral care contraindications, * head and neck trauma, * platelet count below 50 thousand, * could not be positioned appropriately, * agitation

Keywords: oral health oral care intensive care nursing intubation dry mouth
study evaluating long-term safety of atn-103 in subjects with rheumatoid arthritis

Conditions: Rheumatoid Arthritis

Summary: this open-label extension study will allow subjects who have completed either the 3242k1-2000-ww or 3242k1-2001-ja study to receive up to an additional 48 weeks of atn-103 treatment and will provide data on the long-term safety and tolerability of atn-103 in subjects with rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * subjects must have completed study 3242k1-2000-ww or 3242k1-2001-ja and have had no events that, in the opinion of the investigator, would preclude entry or participation in this study. exclusion criteria: * pregnant or nursing women. * any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, cardiovascular, hematological, gastrointestinal, endocrine, pulmonary, immunologic \[eg, felty syndrome, human immunodeficiency virus (hiv) infection\], infectious, neurological, or cerebral psychiatric disease, or evidence of demyelinating disease) that, in the investigator's judgment, will substantially increase the risk associated with the subject's developing an adverse event (ae) or serious adverse event (sae) during the study, or preclude the evaluation of the subject's response.

Keywords: open-label long-term safety study of atn-103 in ra