Kornimate/medical-research-clean huggingface dataset:
randomized, controlled trial with hybrid fractional laser

Conditions: Vaginal Atrophy, Sexual Dysfunction, Vaginal Dryness, Dyspareunia

Summary: this randomized, controlled trial will evaluate hybrid fractional laser treatment for vulvovaginal atrophy in breast cancer survivors and menopausal females


Eligibility criteria:
inclusion criteria: * 1. healthy biological female aged between 40 to 70 years 2. is post-menopausal with a and b or c: 1. no menses for at least 12 months 2. follicle-stimulating hormone (fsh) level over 40mlu/ml 3. has had a bilateral oophorectomy at least 12 months ago with no hormone replacement 3. is experiencing at least two self-reported symptoms of gsm, such as 1. vaginal irritation in the absence of infection 2. chronic burning sensation 3. chronic itching in the absence of infection 4. recurring urinary tract infections (utis) 5. vaginal dryness during sexual activity 6. pain during sexual activity (dyspareunia) 4. has been experiencing symptoms of gsm for greater than 3 months 5. is unable due to a medical contraindication or unwilling to receive hormone-based vaginal therapy 6. early menopause after breast cancer 7. normal and up to date pap smear, if applicable 8. is sexually active (i.e. intravaginal intercourse) or has the potential and desire to be sexually active if symptoms of gsm improve 9. can read, understand and sign informed consent form 10. has indicated willingness to participate in the study by signing an informed consent form 11. agrees to adhere to the treatment and follow-up schedule and post treatment care instructions exclusion criteria: * 1. undiagnosed abnormal genital bleeding 2. has history of pelvic surgery or other energy-based vaginal therapy within 12 months prior to enrollment 3. previous use of topical estrogen therapy within the last 6 months 4. has used vaginal creams, moisturizers, lubricants or homeopathic preparations, or received anticoagulants, antiplatelet, thrombolytic, vitamin e or anti-inflammatory within 2 weeks of treatment 5. has history of heart failure 6. has equal to or greater than stage iii prolapse, according to pelvic organ prolapse quantification system (pop-q) 7. has an active sexually transmitted infection (sti) 8. has signs or symptoms of vulvitis/vaginitis 9. has signs or symptoms of acute urinary tract infection (uti) 10. has participated in any clinical trial involving an investigational drug or procedure within past 30 days 11. the investigator feels that for any reason the subject is not eligible to participate in the study
adipose derived regenerative cells in the treatment of diabetic foot ulcers

Conditions: Diabetic Foot Ulcer

Summary: a prospective, double-blind, multi-center, randomized, parallel-group safety and efficacy study of adipose-derived regenerative cells (adrcs) in the treatment of patients with diabetic foot ulcers (dfu).

subjects will have at least one diabetic foot ulcer between 1 cm2 and 16 cm2 area that remains open despite at least 30 days of dfu care and will need debridement as a part of their care. subjects will be randomly assigned to one of two groups (adrc group will receive standard care plus adrc, and control group will receive standard care plus matched placebo). adrcs will be harvested from a small volume liposuction performed on the same day as, but prior to, the debridement procedure. fat harvest will occur through small volume (approximately 100-200 ml) liposuction prior to the surgical debridement procedure on the same day as the planned autograft procedure. the lipoaspirate will be processed in the celution system to isolate and concentrate adrcs for application to an autograft site. cells will be delivered via direct injection (minimal wound penetration with a 22 gauge needle, total volume 5 ml) into the dfu (injected around the circumference and applied to the base of the ulcer).

Eligibility criteria:
inclusion criteria: * t1d or t2d * diabetic foot ulcer, from 1 to 12 months in duration * wagner grade 1 or superficial 2 * adequate perfusion * able to undergo liposuction exclusion criteria: * diabetic foot ulcer penetrates to capsule, tendon, or bone * active infection * non-diabetic neuropathy * significant cardiovascular event within 6 months before screening

Keywords: diabetic foot ulcer dfu non-healing foot ulcer
safety, tolerability, and pharmacokinetics of single dose tenomir as a treatment for tennis elbow

Conditions: Tennis Elbow

Summary: this study is testing a drug called tenomir that is being developed for the treatment of tennis elbow (lateral epicondylitis). the study drug is a new compound that works by improving the quality of the collagen which helps repair damage to the elbow. the study drug is being developed in the hope of providing a more reliable treatment than those currently available and can be given at the time of first diagnosis, so that recovery can begin as soon as possible.

tenomir a chemically synthesised mimic of microrna-29a (mir29a) which has improved stability, activity and cellular uptake while being non-immunogenic, has been created to restore mir29a levels back to pre-injury levels. tenomir is unique in directly targeting the key changes in collagen production associated with tendinopathy. unlike other therapies, tenomir has a well-defined mode-of-action that is supported by a wealth of scientific data. moreover, treatment with tenomir does not require invasive biopsies and can be delivered at the point of initial diagnosis initiating recovery at the very earliest time.

Eligibility criteria:
inclusion criteria: 1. subject has a clinical diagnosis of lateral epicondylitis. 2. aside from lateral epicondylitis, the subject is otherwise healthy as determined by a responsible physician, based on medical history, physical examinations, concomitant medication, vital signs, 12-lead ecgs and clinical laboratory evaluations. laboratory values may be re-tested once at the discretion of the investigator. 3. subject's symptoms can be reproduced with resisted supination or wrist dorsiflexion (as confirmed by tenderness at lateral epicondyle and positive pick up back of chair sign). 4. subject's symptoms have persisted for at least 6 weeks to 6 months, despite conservative treatment that includes 1 or combinations of: 1. physical therapy 2. splinting 3. nsaids exclusion criteria: subjects with any of the following will be excluded from study participation: 1. subject has undergone previous corticosteroid injection therapy to the affected elbow in less than 6 months prior to enrolment. 2. subjects unwilling or unable to discontinue use of pain medication (opiate or nsaid) from at least 1 week prior to investigational medicinal product (imp) administration. 3. subject has received previous platelet-rich plasma (prp) injection to the affected elbow. 4. subject uses or has recent use of medications known to affect the skeleton (e.g., glucocorticoid usage \>5 mg/day, fluoroquinolone antibiotics). 5. subject has undergone surgical intervention to the affected elbow for the treatment of lateral epicondylitis.
cannabis (thc vs. cbd) in multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the goal of this clinical trial is to examine the effect of cannabis components, thc and cbd, on cognition and bladder symptoms in people with multiple sclerosis (ms). participants will complete questionnaires and cognitive tests. they will be randomly assigned to receive either cbd or thc oil and will take the study drug for 15 weeks.

multiple sclerosis (ms) is a chronic autoimmune disease of the central nervous system. cannabis and cannabis-based medicines (cbm) are often used by persons with ms (pwms). cannabis research to date indicates that its use worsens cognitive function in pwms. additionally, cognitive impairment (ci) is already a frequent consequence of ms, with a significant negative impact on quality of life (qol). this is pilot randomized, double blinded, double arm clinical trial of tetrahydrocannabinol (thc) 25 mg or cannabidiol (cbd) 50 mg orally for 15 weeks in people with ms trial. the investigators will recruit pwms with symptoms of neurogenic lower urinary tract dysfunction (nlutd). these participants can either be on a treatment that has been only partially effective (as per patient report) or has never tried an intervention for their nlutd symptoms. the primary aim is to evaluate the differential effect of the tetrahydrocannabinol (thc) and cannabidiol (cbd) on cognitive outcomes in persons with multiple sclerosis (pwms) using cannabis for nlutd. the results of our proposed study will better inform both healthcare practitioners and patients with respect to the potential risks of treatment with cannabis-based products and any difference with respect to thc vs. cbd-based products.

Eligibility criteria:
inclusion criteria: * age between 18 and 59 years inclusive. * confirmed diagnosis of multiple sclerosis as per mcdonald criteria (any type) \[12\] * symptoms of neurogenic lower urinary tract dysfunction (nlutd) as measured by neurogenic bladder symptom score (nbss), with a minimum score of 7. * if already on a medication for nlutd, must be stable on this medication for at least 4 weeks. * sexually active men and women of child-bearing potential must agree to use adequate contraception. * written informed consent. exclusion criteria: * major psychiatric disorder such as schizophrenia or bipolar disorder * major neurological disorder which could affect cognition such as dementia, traumatic brain injury. * seizure disorder * use of antipsychotic medication * use of benzodiazepines other than exclusively at night/bedtime * experienced a ms relapse in the last ninety (90) days. * current use of cannabis or cbm greater than 3x/week. * currently using cannabis/cbm less than 3x/week and being unwilling to abstain for the duration of the study. * visual acuity (binocular) worse than 20/70 (in order to complete the cognitive outcomes) * significant upper extremity disability that would interfere with the cognitive tests battery. * indwelling catheter use/urinary diversion * pregnant or breastfeeding

Keywords: cannabis cognitive function
pain after endoscopic submucosal dissection

Conditions: Gastric Neoplasm

Summary: endoscopic submucosal dissection (esd) is widely used for local treatment of gastric neoplasms. although esd-related complications such as bleeding and perforation have been reported, data is currently lacking on the development of pain, which is one of the most common adverse events after esd. therefore, in the present study, we investigated the incidence and clinicopathologic risk factors of pain after esd.

a prospective randomized controlled study was conducted evaluating 156 patients with gastric neoplasms treated by esd at gangnam severance hospital between april 2011 and december 2014. all subjects were randomly assigned to treatment with intravenous proton pump inhibitor (ppi) either before or after esd.

Eligibility criteria:
inclusion criteria: * patients undergoing esd for gastric neoplasms exclusion criteria: * (1) history of acid suppressive medication within 1 week prior to the procedure; (2) known gastrointestinal disorders, such as peptic ulcer disease, which might impact epigastric pain assessment; (3) current or regular use of pain medication; (4) history of upper gastrointestinal surgery; (5) multiple lesions requiring esd; (6) perforation during esd; and (7) significant cardiovascular, renal, hepatic, neurotic, or psychological disorders
pragmatic randomised trial of high or standard phosphate targets in end-stage kidney disease (phosphate)

Conditions: Kidney Failure, Chronic; Hyperphosphatemia

Summary: during end-stage kidney disease, clinical guidelines suggest reducing elevated phosphate levels in the blood. however, the effect of lowering blood phosphate levels on important patient-centred outcomes has never been tested. this trial will evaluate whether compared to high levels, lowering blood phosphate levels would reduce death or major events due to heart disease, improve physical health, and be cost-effective.

hyperphosphataemia is highly prevalent in patients with end-stage kidney disease (eskd) and associated with increased mortality risk. the clinical practice guidelines suggest lowering elevated phosphate levels towards the normal range (level 2c suggestion). however, trial data demonstrating that treatments that lower serum phosphate will improve patient-centred outcomes are lacking. the primary objective is to test the hypothesis that compared to a liberal serum phosphate concentration target of 2.0 to 2.5 mmol/l, intensive lowering of serum phosphate towards the normal level (≤1.50 mmol/l) with phosphate binders reduces the risk of fatal or non-fatal major cardiovascular events in eskd patients receiving dialysis. the secondary objectives are to test the hypothesis that intensive lowering of serum phosphate towards the normal level with phosphate binders would improve physical health, fatigue, health-related quality of life, patient satisfaction, and pruritus; and be cost-effective. in this pragmatic, multinational, randomised controlled large simple trial, a total of 3600 adult eskd patients receiving dialysis will be randomised either to intensive (≤1.50 mmol/l) or liberalized (2.0-2.5 mmol/l) serum phosphate target. the choice and dose of phosphate binders will be at the treating physician's discretion and local practice to achieve and maintain serum phosphate concentration within the required target range according to randomisation. the primary endpoint is the composite endpoint of cardiovascular death, non-fatal major cardiovascular or peripheral arterial events. the secondary outcome measures will be individual components of the primary composite endpoint, all-cause death, and utility-based quality of life eq5d-5l.

Eligibility criteria:
inclusion criteria: 1. age ≥45 years, or age ≥18 years with diabetes, 2. eskd on haemodialysis or peritoneal dialysis, for at least 3 months, 3. currently prescribed at least one phosphate-lowering medication at any dose 4. able to provide informed consent exclusion criteria: 1. elective kidney transplantation scheduled, 2. concomitant major illness / comorbidity that may result in death in the next 6 months in the view of the treating physician, 3. participation in an interventional study that is likely to affect serum phosphate concentration.

Keywords: renal dialysis randomised controlled trial bone markers cardiovascular risk factors phosphate lowering agent end stage kidney disease hyperphosphatemia
extended treatment and follow-up of subjects treated with belumosudil in study kd025-208 or study kd025-213

Conditions: Chronic Graft-versus-host-disease

Summary: extended treatment and follow-up of subjects treated with belumosudil in study kd025-208 or study kd025-213

this is a phase 2, open-label, long-term treatment and follow-up study in subjects with cgvhd who have been previously treated with belumosudil in study kd025-208 or study kd025-213. subjects will not be screened. subjects who have signed the informed consent form will be enrolled in study kd025-217 if they have met 1 of the following conditions: * actively receiving belumosudil or in long-term follow-up (ltfu) in study kd025-208 or study kd025-213 * enrolled in the companion study as specified in study kd025-213 amendment 2 and received at least 6 months of treatment or is in ltfu approximately 20 study centers will participate with approximately 70 subjects participating overall.

Eligibility criteria:
inclusion criteria: subjects must have been treated with belumosudil for at least 1 of the following: * actively receiving belumosudil on study kd025-208 or study kd025-213 * is in long-term follow-up (ltfu) on study kd025-208 or study kd025-213. long-term follow-up will be defined as the period after ending treatment with belumosudil and until a ffs event occurs. * adult enrolled in the companion study under kd025-213 amendment 2 (01 june 2020) and has received at least 6 months of treatment of belumosudil or is in ltfu exclusion criteria: * female subject who is pregnant or breastfeeding * subject considered unlikely to adhere to treatment and/or follow protocol in the opinion of the investigator
the trial of pessary after laser for ttts

Conditions: Premature Birth

Summary: placing a cervical pessary in severe twin-to-twin transfusion syndrome (ttts) cases treated by fetoscopic laser coagulation (flc) decreases the spontaneous preterm birth rate.

monochorionic (mc) twin pregnancies present with a high rate of fetal complications, most of them associated with the placental vascular anastomoses. fetoscopic laser coagulation (flc) is a surgical technique that allows minimally invasive access into the uterus and has emerged as a useful tool in the management of the most common and severe of these complications, twin to twin transfusion syndrome (ttts). even though, preterm birth remains a common cause of adverse outcome because ttts is associated with a 29% risk of delivering before 28 weeks. a short cervical length (cl), defined as a cl ≤ 25 mm, detected by transvaginal ultrasound is an independent risk factor for preterm birth in twin pregnancies but no effective treatment has been described to prevent it. although is usually accepted that in twin pregnancies cerclage may increase the risk of preterm birth, salomon and co-workers, found that in cases of ttts with a cl below the 5th percentile (15 mm) at the time of surgery, performing an emergency cerclage prolonged the pregnancy and allow for better outcome, but still preterm birth after flc remains a big challenge, so new methods to prevent it must be investigated. previous studies in singletons and twins have shown that the use of cervical pessary significantly reduces the frequency of birth before 32 weeks and prolongs pregnancy. the advantage of using cervical pessary is that it is less invasive than cerclage and can be removed easily. that's the reason why pessaries could be considered an alternative, non invasive option to prevent preterm birth in cases of twin to twin transfusion syndrome (ttts) treated by laser surgery.

Eligibility criteria:
inclusion criteria: * monochorionic twin pregnancies with severe ttts requiring intrauterine surgery * less than 26 weeks * minimal age of 18 years * informed consent signature exclusion criteria: * major fetal abnormalities (requiring surgery or leading to infant death or severe handicap) * cerclage prior to randomisation * uterine malformation * placenta previa * active vaginal bleeding at the moment of randomization * spontaneous rupture of membranes at the time of randomization * death of both twins after the surgery * monochorionic-monoamniotic twin pregnancy * silicone allergy * current participation in other rct

Keywords: monochorionic pregnancy twin to twin transfusion syndrome cervical pessary cervical length
effects of nurse-led supportive care programme on caregiver burden and resilience of family caregivers

Conditions: Nurse-led Supportive Care

Summary: lung cancer is the leading cause of cancer-related deaths worldwide, with a mortality rate of 18%. the prognosis of lung cancer is progressive and devastating, which may cause patients to experience problems during the treatment and care process. due to the problems experienced by lung cancer patients, their need for support increases and the care process is provided mostly in the home environment, causing family members to take on important roles as caregivers. therefore, the resilience of family caregivers decreases and they feel burden.


Eligibility criteria:
inclusion criteria: * a family member who has been a primary caregiver for at least one year * literate * willingness to participate in the study exclusion criteria: * have any communication disability * have any diagnosed physical or psychological disorder * receiving any supportive care

Keywords: lung cancer family caregivers caregiver burden resilience
periodontal outcomes after sanative therapy

Conditions: Periodontal Pocket; Xerostomia; Dry Mouth; Periodontal Diseases

Summary: salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects salivary gland production. absence of saliva causes bad breath, dental decay, increased plaque accumulation, dry lips, mouth sores, and the inability to retain dentures or removable protheses. this study will determine if patients with dry mouth have different periodontal health than patients without dry mouth. additionally, this study will examine if patients who have their periodontal maintenance appointments solely at a periodontal speciality clinic have different periodontal health than patients who alternate their appointments between a specialty office and their general dental office.

salivary gland hypofunction, or dry mouth, is a damaging oral condition that affects the function and flow rate of saliva. low saliva rates can range from mild self-reported symptoms and discomfort to significant oral diseases. saliva is essential in preventing irritation and friction of mucosal surfaces. progressively dry mouth can cause oral and bodily conditions that can affect an individuals quality of life and daily tasks, such as eating and avoiding social situations. specifically, dry mouth is a risk factor for periodontal disease, a chronic oral inflammation of tissues and ligaments that support the tooth's structure and if untreated, will ultimately lead to tooth loss. in canada, the first line of defense against periodontal disease is non-surgical sanative therapy (st). participants in this study have been attending a periodontal specialty clinic for routine periodontal maintenance appointments for at least 1 to 5 years following their initial scaling and root planing. salivary flow rate will be measured to determine the level of dry mouth. at the regular maintenance appointment, clinical measures will be evaluated (probing depth, bleeding on probing, plaque index, gingival index, thickness of tissues, mobility, and furcations). patients will also complete a dry mouth questionnaire to determine if dry mouth influences the day to day life of a patient, and the patient's registered dental hygienist will complete a short questionnaire outlining oral symptoms of dry mouth. additionally, the investigators aim to see if a patient who has periodontal maintenance appointments at a specialty office has different clinical outcomes than a patient who alternates these appointments between a specialty office and a general dental office. overall, the investigators will determine if thorough periodontal maintenance appointments are efficient in preventing periodontal disease in patients with dry mouth.

Eligibility criteria:
inclusion criteria: * have had sanative therapy at this clinic in the previous 1 to 5 years. exclusion criteria: * anyone who is unable to provide informed consent

Keywords: healing biomarkers sanative therapy nutritional supplements medications salivary flow