Kornimate/medical-research-clean huggingface dataset:
the effect of cyclofem® for the treatment of irregular uterine bleeding in implant contraceptive users

Conditions: Uterine Bleeding

Summary: the purpose of this study is to determine that once-a-month injectable contraceptive( cyclofem® ) has the effect on treatment of irregular uterine bleeding in implant contraceptive users or not.

stratified randomization implanon and jadelle group were done using block randomization. the participants and investigators were blinded to treatment allocation, using drug coding that not revealed until the end of study. research assistants and nurse who did not have involve in analyses data would follow the recruitment criteria and drug injection follow the code of drug. all participants were collected demographic data, medical history, obstetrical and gynecological history, bleeding pattern before enrollment. then physical exam and pelvic examination were performed for all participants. participants received single dose intramuscular injection of cyclofem® 0.5 ml or normal saline 0.5 ml as placebo on that day of recruitment to the study. daily record of bleeding, spotting and side effect was done on record form.

Eligibility criteria:
inclusion criteria: * implant (jadelle or implanon) inserted before enrollment with the symptom of bleeding disturbances for eight or more continuous days or a current bleeding-free interval of 15 days or less * regular menstruation at least 1 cycle before the usage of implant contraceptive * willingness to participate in a placebo-controlled study and ability to keep an accurate daily menstrual record * no gynecological or serious medical diseases exclusion criteria: * contraindication to estrogen or progesterone use such as * breast cancer * liver cancer or tumor * uncontrolled blood pressure (bp ≥160/100 mmhg ) * history of atherosclerosis, vascular disease and high risk for vie * history of ischemic stroke * coagulopathy * uncontrolled diabetes mellitus and complication * cirrhosis * sle with antiphospholipid positive * history of migraine with aura or age of 35 years old or more than with history of migraine non-aura * age of 35 years old or more than with history of smoking more than 15 cigarettes per day * postpartum 6 weeks * plan for surgery procedure that need immobilization after surgery * previous treatment for 3 months before enrollment * allergic to drug component of cyclofem® ( medroxyprogesterone acetate , estradiol cypionate)

Keywords: cyclofem® implant jadelle implanon irregular uterine bleeding randomized controlled trial
sepa iii: the effectiveness trial

Conditions: HIV Prevention

Summary: the study evaluates the effectiveness of sepa (salud, educacion, prevencion y autocuidado; health, education, prevention and self-care) to increase hiv prevention behaviors and to reduce the incidence of stis for hispanic women when delivered in a real-world setting by community agency personnel. the study recruits hispanic women between the ages of 18 and 50 who are sexually active and are randomized to either sepa or a wait-list control condition.


Eligibility criteria:
inclusion criteria: * hispanic women, * 18 to 50 years old, * sexually active in the past three months exclusion criteria: * non-hispanic, * younger than 18, * older than 50, * not sexually active
resveratrol: a potential anti- remodeling agent in heart failure, from bench to bedside

Conditions: Dilated Cardiomyopathy

Summary: the purpose of this study is to determine if resveratrol can improve heart function and quality of life. although, population studies have revealed that a mild to moderate intake of red wine reduces cardiovascular disease risk in humans, clinical studies that evaluate the potential heart benefits of resveratrol in patients with non-ischemic cardiomyopathy have not been previously reported. accordingly, this research is being done because it will fill this deficiency in the information available in the literature and establish the clinical benefits of resveratrol in patients with this type of heart disease.

the investigators will conduct a randomized double blinded placebo controlled study of 40 adults (≥18 to 90 years old). twenty (20) subjects will be included in the placebo arm, and 20 in the treatment arm. patients will be randomly allocated to receive placebo or resveratrol. after randomization, the two groups of subjects will be followed up in exactly the same way, and the only differences between the care they receive will be those intrinsic to the treatment being compared. the randomization will minimize allocation bias, balancing both known and unknown prognostic factors, in the assignment of treatments.

Eligibility criteria:
inclusion criteria: * subjects (between 18-90 years of age) with cardiomyopathy, heart failure with reduced ejection fraction (hfref defined as left ventricular ejection fraction (lvef) ≤40%, based on most recent assessment) * new york heart association (nyha) functional class ii-iii (mild-moderate heart failure symptoms) * on optimal medical management for 6 months as per standard care exclusion criteria: * severe valvular cardiomyopathy * no surgical intervention planned or in past 6 months * subjects on \\diltiazem (or any other calcium channel blocker) * patients with a history of serious hypoglycemia requiring hospitalization or hyperglycemic emergencies requiring hospitalization in the past 6 months * subjects on anticoagulants, coumadin, dabigatran * subjects on hiv protease inhibitor (saquinivir), immunosupressants (cyclosporine, tacrolimus) * subjects on terfenadine, midazolam, and triazolam * subjects on sildenafil or any other drugs used to treat erectile dysfunction * • chronic renal failure (defined as estimated glomerular filtration rate (egfr) ≤30 ml/min per 1.73m2) * known liver cirrhosis * • other significant comorbidity e.g. cancer affecting ability to complete study * pregnant or lactating women * subjects on hormone replacement therapy * subjects on estrogen containing birth control

Keywords: dilated cardiomyopathy resveratrol
evaluation of enhanced therapeutic effect of adipose stromal vascular fraction added with human platelet lysate in treatment of osteoarthritis

Conditions: Assessment of the Trophic and Anti-inflammatory Effect of SVF Added With HPL

Summary: osteoarthritis (oa) is a highly progressive and debilitating joint disease. recently, it was demonstrated the existence of an important link between oa inflammation and progression of structural changes. therapy with intra-articular injection of stromal vascular fraction (svf) holds great promises and its efficacy could be further augmented with the addition of biological adjuvants. in the present project, we aim at demonstrating that human platelet lysate (hpl) increases the intrinsic beneficial properties of svf on cartilage regeneration and joint environment. moreover, we want to verify if svf-conditioned medium (cm) obtained from svf primed with hpl yields comparable or superior outcomes than whole svf.


Eligibility criteria:
inclusion criteria: oa patients * subscription of informed consent * bmi \< 30 * age between 55-75 years included * kelgrenn-lawrence equal or superior to grade iii * presence of synovitis * patients undergoing knee replacement * suspension of nsaids from one week before the surgical procedure according to the standard clinical practice healthy subjects from aesthetic plastic surgery * subscription of informed consent * bmi \< 30 * age between 18-50 years included * subjects undergoing liposuction and/or abdominoplasty exclusion criteria: * hcv, hiv, hbv, tpha infection * pregnancy (auto declaration)
medication misuse and dependence among elderly

Conditions: Mild Cognitive Impairment; Elderly; Substance-Related Disorders

Summary: the project focuses on investigating problematic medication use, especially overuse of potentially addictive drugs among the elderly. the investigators aim firstly to develop and validate instruments for detecting and describing behavioral aspects and consequences of dependence on, and misuse of, prescription medication among elderly. in addition to evaluating diagnostic utility of screening instruments, the investigators aim to identify and report characteristics, risk factors and consequences of medication misuse and dependence among the elderly.

elderly represent a particularly vulnerable group with many contributing factors including age-related multifactorial morbidity, cognitive function, polypharmacy, dependence and multiple prescribers with suboptimal communication. centrally active pain killers and sedative/hypnotic medications give increased risk of addiction, adverse drug events, reduced physical and/or cognitive function. the project comprises diagnostic accuracy, descriptive screening, cross-sectional and case-control studies, with aims to: i) assess diagnostic utility of instruments for elderly patients; ii) describe risk factors for medication misuse and dependence; iii) describe consequences of the use of centrally active medications among elderly compared to a control population. moreover, the investigators aim to examine the association between medication misuse and changes in cognitive function, focusing on deficits in specific domains of cognition. an additional aim is to explore the possibility of dissociating such cognitive changes from other causes of mild cognitive impairment (mci) associated with development of dementia.

Eligibility criteria:
inclusion criteria: * admitted to geriatric or neurology dept of hospital during inclusion time exclusion criteria: * mmse \< 21, * diagnosis of pre-existing severe depression or psychotic disease, * pre-existing dementia diagnosis, * new pain requiring start-up of central pain killers not previously used, * palliative treatment. * insufficient norwegian language * serious visual disturbance and hearing impairment * strongly reduced general health precluding partcipation in interview and questionnaires

Keywords: addiction cognition impulsivity neuropsychology prescription drug misuse dependence
reaching consensus on the definition of difficult cholecystectomy

Conditions: Cholelithiasis

Summary: being able to predict the difficulty of a preoperatively can increase safety and improve results. however, a consensus must be reached regarding the definition of a cholecystectomy as "difficult". the aim of this study is to achieve a national expert consensus. methods a delphi study was conducted. based on the literature, a history of biliary pathology, preoperative clinical, analytical, and radiological data, and intraoperative findings were selected and rated on a likert scale. inter-rater agreement was defined as "unanimous" when 100% of the participants gave an item the same the likert scale rating; as "consensus" when ≥80% agreed; as "majority" when the agreement was ≥70%.

a delphi study was conducted. inter-rater agreement was defined as "unanimous" when 100% of the participants gave an item the same the likert scale rating; as "consensus" when ≥80% agreed; as "majority" when the agreement was ≥70%.

Eligibility criteria:
inclusion criteria: * spanish surgeons * experts in laparoscopic cholecystectomy, with more than 10 years of experience exclusion criteria: * not spanish * not experts in laparoscopic cholecystectomy.
epidermal grafting in wound healing

Conditions: Ulcer; Skin Ulcer; Wounds and Injuries

Summary: split thickness skin grafting is the normal standard of care for wound closure. however, this is an invasive procedure and associated with pain also there can be additional donor site morbidity. epidermal grafting is an emerging clinical alternative that is gaining clinical practise. epidermal grafting (eg) is an alternative method of autologous skin grafting that 'harvests' a finer layer of skin than traditional split thickness skin grafting (ssg). this potentially results in less pain and reduced donor site morbidity but only delivers several cell layers to the wound so may be less effective at healing a wound. it is not known if eg is an effective alternative to ssg. further the mechanism to achieve wound healing may be different. eg promotes wound healing by expressing growth factors that accelerates wound healing and encourages keratinocyte migration. whereas ssg is a transplant of several skin layers that integrated to the existing wound bed as a formal skin covering. the investigators wish to compare these two clinical practises; epidermal grafting and split thickness skin grafting in wound healing. further to undertake a translational study to investigate the mechanism by which each technique achieves wound healing.

this study evaluates the efficacy of eg, as an alternative to current wound management therapy, ssg. in a pilot study carried out in our centre (unpublished data), the investigators noted that this technique offers a method of autologous skin harvesting with minimal or no pain and a scar free donor site. moreover, complete wound epithelialisation was achieved while maintaining patient independence. therefore, this device has the potential to save healthcare resources, by eliminating the need for theatre space and a hospital bed, and result in better patient reported outcomes measures.

Eligibility criteria:
inclusion criteria: 1. male or female 2. age 18-90 3. wound measuring more than 1cm x 1cm and lesser than 5cm x 5cm (1% tbsa) 4. wound with clean, healthy granulating bed, with minimal adherent slough 5. patient understands and is willing to participate and can comply with weekly visits and follow-up regime exclusion criteria: 1. wound with active infection 2. wound at plantar of the foot 3. patients unsuitable for split skin grafting 4. previous history of excessive bleeding associated with surgical biopsies or trauma 5. allergies to tegaderm (and other dressings used in the study) 6. known uncontrolled diabetes mellitus, as measured by an hba1c \> 10%. 7. presence of one or more medical conditions, including renal, hepatic, hematologic, active auto-immune or immune diseases that, would make the subject an inappropriate candidate for this ulcer healing study 8. patient not fit for surgery (asa classification \> 4)

Keywords: epidermal graft suction blister blister graft suction graft epidermis/su, tr [surgery, transplantation]
cranberry effect on urinary tract infections

Conditions: Urinary Tract Infections

Summary: this is a retrospective chart review using electronic privacy identification center (epic) database to determine if the addition of cranberry juice capsules to our discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery reduced the incidence of uti.

the incidence of urinary tract infection (uti) in women undergoing pelvic floor gynecologic surgery is high, ranging from 10-64%. a recent randomized trial showed that cranberry juice capsules significantly reduced the incidence of uti in patients undergoing elective gynecologic surgery (19% vs 38%; odds ratio 0.38 with confidence interval 0.19-0.79). cranberry juice capsules were incorporated into the standard practice of cincinnati urogynecology associates, trihealth inc in mid-march 2016. currently, all patients who undergo pelvic floor gynecologic surgery and are discharged from the hospital with an indwelling urinary catheter postoperatively are prescribed cranberry juice capsules to reduce the risk of uti. the purpose of this study is to determine if the addition of cranberry juice capsules to the discharge medication regimen for patients discharged home with an indwelling urinary catheter following pelvic floor gynecology surgery significantly reduced the incidence of uti, compared to a separate cohort that did not have cranberry prescribed.

Eligibility criteria:
inclusion criteria: * underwent pelvic floor gynecologic surgery between april 2015 and september 2015, and april 2016 and september 2016 * required indwelling urinary catheter use upon discharge from the hospital. exclusion criteria: * intraoperative bladder injury, fistula repair, urethral diverticulectomy, or any other need for prolonged catheterization * complications in the 2 weeks following surgery requiring reoperation and subsequent catheter use * allergy to cranberry or its components * failure to present for both the two-week and six-week postoperative office visit
comparison of tear evaporation rate with systane complete in dry eye and non-dry eye

Conditions: Evaporative Dry Eye

Summary: the objective of the study is to compare the rate of tear evaporation, measured with a novel evaporimeter, before and for one hour after an eye drop containing nano-sized oil droplets has been instilled.


Eligibility criteria:
inclusion criteria: 1. is at least 18 years of age and has full legal capacity to volunteer; 2. has read and signed an information consent letter; 3. is willing and able to follow instructions and maintain the appointment schedule; 4. is willing to be awake for at least 2 hours before visit 2; 5. is willing not to wear eye makeup on the day of visit 2; 6. is willing not to use eye drops or artificial tears on the days of visits 1 or 2; 7. group specific criteria: 1. dry eye participant group: symptoms: osdi ≥ 13 and signs: nikbut ≤ 5 s in the worst eye 2. non-dry eye participant group: symptoms: osdi \< 13 and signs: nikbut ≥ 10 s in the worst eye exclusion criteria: 1. is participating in any concurrent clinical or research study; 2. has any known active\* ocular disease and/or infection; 3. has a systemic condition that in the opinion of the investigator may affect a study outcome variable; 4. is using any systemic or topical medications that in the opinion of the investigator may affect a study outcome variable; 5. has known sensitivity to sodium fluorescein dye; 6. is pregnant, lactating or planning a pregnancy at the time of enrolment (by verbal confirmation at the screening visit); 7. is aphakic; 8. has undergone refractive error surgery; 9. has undergone ocular surgery in the last 6 months; 10. has punctal plugs; 11. has a known sensitivity to systane eye drops (including systane balance, systane complete, systane gel drops, systane ultra, etc.) 12. has a known sensitivity to petroleum jelly (vaseline); 13. has epilepsy and/or sensitivity to flashing lights; 14. has worn contact lenses within the past month or is planning to wear contact lenses during the study; 15. has any physical impairment that would interfere with holding the evaporimeter; 16. has taken part in another clinical research study involving ocular drops or treatments within the last 14 days; \* for the purposes of this study, active ocular disease is defined as infection or inflammation which requires therapeutic treatment. mild (i.e. not considered clinically relevant) lid abnormalities (blepharitis, meibomian gland dysfunction, papillae), corneal and conjunctival staining and dry eye are not considered active ocular disease. neovascularization and corneal scars are the result of previous hypoxia, infection or inflammation and are therefore not active.
the inner garden and care for children with moderate to severe agitation

Conditions: Child Behavior Disorders

Summary: the objective is to compare the care including the solution of ambient sensory biofeedback "inner garden", compared to the care without this solution, on the regulation of behavioral disorders during a crisis requiring to take the child out of group care. the nursing support with the "inner garden" tool in three care units will be compared with the practice in six other units not equipped with this tool.

psychiatric illnesses affect more than one person in five each year. in france, the majority of disorders among minors under the care of child psychiatry in full or part-time hospitalization are disorders of psychological development (32%) and behavioural and emotional disorders (24.6%). hospitalisation is reserved for the most complex acute crisis situations, as well as for children who need to be cared for by a multidisciplinary team several times a week to support their psychological development. in our study, the investigators focus on one of the clinical manifestations regularly present: the state of agitation when its intensity is moderate to severe. "the state of agitation is defined as a psychic, motor and relational behavioural disorder that leads to a reaction of intolerance on the part of people in the entourage". the care teams will then implement care actions that will be a graduated response adapted to the intensity of these states of agitation. in addition to the support provided by a caregiver, the investigators propose to use the "inner garden" system developed in 2014 at the laboratory of national institute for research in digital science and technology in bordeaux. it is an interactive zen garden allowing to present feedback (topographical, physiological) under different sensory modalities.

Eligibility criteria:
inclusion criteria: * taken care in children's hospitalization unit of child psychiatry department, * parent affiliated or beneficiary of social security, * information to the child and the legal representative(s) and signed consent by the legal representative(s). exclusion criteria: * refusal to participate on the part of the child and/or legal representative(s).
effects of probiotics and nutritional status on exercise-induced symptoms, and endurance performance in ultra-endurance athletes

Conditions: Ultra-endurance Athletes With Gastrointestinal Symptoms

Summary: ultra-endurance athletes have been commonly endured extreme conditions during races and training sessions, resulting in exercise-associated clinical symptoms, including gastrointestinal symptoms, dehydration, and elevated oxidative stress. although these alterations adversely affect sports performance and well-being, there is no certain treatment or consensus on alleviating the exercise-associated clinical symptoms in ultra-endurance athletes. the objective of this study is to determine the effects of oral rehydration salts supplemented with lactobacillus rhamnosus gg on exercise-induced gastrointestinal problems, dehydration and oxidative stress in ultra-endurance athletes. additionally, we aimed to assess the exercise-induced alterations in oxidative stress determined by applying an acute strenuous exercise protocol ((a cycle ergometer (45 min at 65%vo2max) immediately followed by a treadmill test (75% vo2max to exhaustion)) before and after the supplementation period.


Eligibility criteria:
inclusion criteria: * participants who train at least 15 h per week, * participants who do not have any metabolic disease, * have had at least one gastrointestinal symptom determined by using a gastrointestinal symptoms rating scale and bristol stool chart form scale, * being a non-smoker, * have participated in at least one ultra-endurance race/event (lasts \> 4 hr), * taking no vitamins, minerals, dietary supplements, antibiotics, and any medication at least during the three months before the study, * (for women) participants with a regular menstrual cycle of physiological length (24-35 days) exclusion criteria: * regular tobacco use * inability to adhere to any of the study protocol requirements (i.e. alcohol, caffeine consumption, diet control) * having consumed any supplements and/or medicines for the preceding 3 months period. * (for women) participants in menopause or using oral contraceptives

Keywords: signs and symptoms, digestive probiotics oral rehydration therapy gastrointestinal microbiome