Kornimate/medical-research-clean huggingface dataset:
laser and radiofrequency for treatment of vaginal vulvar atrophy (vva) in women treated for breast cancer (epmlarf-arm2)

Conditions: Vaginal Atrophy; Vulva; Atrophy; Breast Cancer

Summary: this is a randomized controlled trial to evaluate the use of laser, micro ablative radiofrequency and topic promestriene to treat symptoms of vulvovaginal atrophy of women treated for breast cancer.

women treated for breast cancer with moderate or severe signs or symptoms of vulvovaginal atrophy will be eligible for the study. the patients will be randomized to receive one of the three intravaginal therapies: laser, micro ablative radiofrequency or promestriene. the applications will occur in the interval of 30 days for 3 times, for laser and radiofrequency groups. for the promestriene group, the application will be done by the patient, daily for 2 weeks and then twice a week for 3 months, and each 30 days, the patients will have an appointment when will be checked the weight of the promestriene tube, to verify the correct use. the follow-up visits will occur 30, 90, 180 and 360 days after the conclusion of the third month of treatment. will be evaluated: vulvar and vaginal histology before and after the use of laser, radiofrequency or estriol; microbiota and vaginal ph before and after the use of laser, radiofrequency or promestriene; extracellular matrix and metalloproteinases in the remodeling of vulvovaginal collagen induced by promestriene, laser and radiofrequency; quality of life, sexual dysfunctions and complains before and after the use of laser, radiofrequency or hormones; metabolomics and vaginal microbiome.

Eligibility criteria:
inclusion criteria: 1. women with breast cancer treated with surgery and / or chemotherapy and / or radiotherapy, that has been concluded at least 6 months before inclusion, whether or not using aromatase inhibitor and complaining of vulvovaginal atrophy 2. to present, at least moderate, or severe intensity (score 4 or more of visual analog scale ( 0-10)) of one of the signs or symptoms of vulvovaginal atrophy: * burning * discomfort * dryness * cracks * pruritus * lack of vaginal lubrication * penetration dyspareunia that began at the menopausal or postmenopausal transition * decreased vaginal epithelium turgor and trophism * deletion of mucous and skin folds. 3. absence of vaginal surgical procedure in the last year 4. genital prolapse stage no greater than stage ii of pelvic organs prolapse quantitation (pop-q) with ba, bp or c points less than or equal to 0 exclusion criteria: 1. active genital infection 2. active infection of hpv (human papillomavirus) or herpes 3. users of medications with estrogenic effect (digoxin and other chemicals) 4. postmenopausal genital bleeding 5. uncontrolled diabetes 6. use of multivitamins with zinc 7. use of copper or hormonal iuds (intrauterine device) at the time of inclusion 8. presence of genitourinary or rectovaginal fistulas

Keywords: laser radiofrequency vulvovaginal atrophy breast cancer treatment
entertainment media to deliver educational messages about mammography in saudi arabia

Conditions: Breast Cancer; Behavior

Summary: this clinical trial aims to test if elissa's entertainment-education (ee) song can influence saudi females' intention to perform breast cancer early screening via mammogram.

this study will be guided by a scarcely applied theoretical model that integrates the issue involvement concept into the theory of planned behavior (tpb) to test the role of issue involvement in predicting intention to perform breast cancer early screening via mammogram among saudi females after exposure to ee message.

Eligibility criteria:
inclusion criteria: * saudi arabian * female exclusion criteria: * females 39 or younger * females above age 69 years * females who have had breast cancer * females that have had risk-reducing bilateral mastectomies

Keywords: mammogram prevention
normative values and forming regression equations for one minute sit to stand test in healthy normal indian population

Conditions: Human Healthy Volunteers

Summary: this study is to find relation between number of repetitions the volunteer able to sit and stand in an armless chair and their age, height, weight and gender. the investigators hypothesis there is a moderate relation between anthropometric characteristics and number of situps. this may partially define the ability of functional capacity and quadriceps ability.

sit to stand is gaining importance as a functional capacity measurement tool in modern chronic diseases arena. bu the reference values for normative population is not available. hence the present study aimed at finding relation between the anthropometric variables (age, height, weight) and number of sit to stand repetitions. the volunteers will be asked to sit to stand in an arm less chair of 40 inches height. the number of repetition will be correlated and regression equations will be sought out relating number of repetitions and anthropometric variables through best fit regression equations

Eligibility criteria:
inclusion criteria: * both genders * 30 - 80 years old * hospital staffs, relatives of patients volunteering the test * willing to give consent for the test exclusion criteria: * chronic cardiovascular and pulmonary diseases * on anticoagulants * cancer undergoing chemo, radiotherapy * recent orthopaedic ailments (osteoarthritis, rheumatoid arthritis, surgeries less than 3 months) * balance impairments

Keywords: correlation sit to stand repetitions anthropometric variables age height weight gender regression
study to compare the effects of repeated doses of an investigational new drug and a placebo on appetite in advanced cancer and anorexia

Conditions: Non-small Cell Lung Cancer; Pancreatic Cancer; Colorectal Cancer; Prostate Cancer; Breast Cancer; Ovarian Cancer; Loss of Appetite; Fatigue; Cachexia; Anorexia

Summary: study to compare the effects of the investigational new drug (pf-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated subcutaneous (sc-injected under the skin) doses.

a 6 week double blind study to compare the effects of the investigational new drug (pf-06946860) and a placebo on appetite and to find out how participants with advanced cancer and anorexia feel after receiving repeated doses injected under the skin (subcutaneously). during the initial 6-week treatment period (part a), a total of 2 doses of study drug or placebo will be administered 3 weeks apart. each dose contains two injections. part b is an optional 18-week open-label treatment period where up to 7 doses of study drug may be administered. part b does not include placebo. assessments include: * measure the impact of the study drug on appetite, fatigue, and pain questionnaires * body weight measurements * blood samples to evaluate safety and additional endpoints including the amount of the study drug in the blood and the effects of the study drug on levels of a specific cytokine.

Eligibility criteria:
key inclusion criteria: * documented diagnosis of non-small cell lung, pancreatic, colorectal, prostate, breast or ovarian cancer which, in the treating oncologist's assessment, is considered advanced. * anorexia as defined by a score of ≤5 in the cancer-related cachexia symptom assessment appetite 7-day recall scale * meets any of the following criteria at randomization: * not currently receiving antineoplastic therapy * on standard of care systemic antineoplastic therapy or treatment without curative intent * signed informed consent. key exclusion criteria: * receiving tube feedings or parenteral nutrition at the time of screening or randomization. * current active reversible causes of decreased food intake. * current, severe gastrointestinal disease * participants with known symptomatic brain metastases requiring steroids. * active uncontrolled bacterial, fungal, or viral infection, including hbv, hcv, hiv or participants with known aids-related illness * inadequate renal or liver function. * women who are pregnant or breast-feeding

Keywords: cancer, anorexia, cachexia, weight loss, loss of appetite, fatigue
vielight rx plus for the treatment of covid-19 respiratory symptoms

Conditions: COVID-19

Summary: the objective of this study is to obtain data on the efficacy of the vielight rx plus in decreasing time to recovery of symptoms in subjects with covid-19. the study will be conducted among covid-19 positive subjects at home in self-isolation via electronic data collection (edc). there will be no physical contact between the subjects and the qualified investigator (qi) or other study staff. this study aims to demonstrate that the vielight rx plus is a useful adjunct to standard of care (soc). we hypothesize that the vielight rx plus will accelerate recovery and reduce viral infection severity.

this study is conducted entirely online. at no point will study staff be in direct contact with participants. the study will be managed by an independent clinical research organization (cro), supporting a qualified investigator (qi). vielight inc will supply the rx plus devices free of charge and will sponsor the study. potential participants will be prompted to complete an online screening form if they are interested in participating. during the screening, the potential participant will be asked to upload a copy of their positive covid-19 infection confirmation report and a valid id. if the potential subject qualifies for the study, by statisfying all inclusion and exclusion criteria, the potential participant will then be prompted to complete an electronic informed consent form (icf) via the electronic data collection (edc) platform and will be enrolled into the study. this is a 30-day, prospective, randomized study, with no blinding. 280 participants will be randomized into two groups: group 1: standard of care; group 2: standard of care + vielight rx plus treatment. in group 2, the vielight rx plus will be administered for 20 minutes twice a day, separated by at least 6 hours for the first 5 days. for the subsequent 25 days, treatment will be once per day. the vielight rx plus will be positioned over the upper most part of the breastbone to stimulate the thymus gland and within one nostril. during each of the 30-days, participants will be asked to complete a questionnaire to assess respiratory symptom severity, and log a daily dairy as well as oxygen saturation level (using a portable oximeter). the primary measure is time to overall recovery in days.

Eligibility criteria:
inclusion criteria: * confirmation of covid-19 infection * experiencing moderate to severe respiratory symptoms * between 18-65 years of age exclusion criteria: * need for hospitalization at the time of diagnosis * current need for supplemental oxygen or positive pressure support and/or has required supplemental oxygen or positive pressure support for \>or= 24 hours * \>10 days since symptom onset * diagnosis of chronic obstructive pulmonary disease (copd) * pregnant * positive for hepatitis c virus (hcv), hepatitis b virus (hbv) or human immunodeficiency virus * inability to electronically complete study questionnaires in english

Keywords: covid-19 sars-cov-2 photobiomodulation low level light therapy pbm red light near-infrared light at-home treatment remote
endoscopic full thickness resection versus standard therapy of the colorectal neoplasia

Conditions: Polyps; Colon Cancer

Summary: most of the cancers develop from the adenomatous polyps. the therapeutic methods have been established already - endoscopic polypectomy (epe) for stalked polyps and endoscopic mucosal resection (emr) or endoscopic submucosal dissection (esd) for non-pedunculated polyps. emr is preferred in european countries over esd because of its higher feasibility. however, the local residual neoplasia (lrn) after emr has been reported in 14 - 24 % cases. there is a higher lrn risk in sessile polyps which do not elevate sufficiently after the submucosal injection (non-lifting sign) and the piece-meal resection needs to be used. therefore, the new method of endoscopic full-thickness resection (ftr) has been developed to resect these lesions.

in this project, 80 individuals (age ≥ 18 years) with colorectal lesions of 10-25 mm size with positive non-lifting sign will be included. such lesions might be found during the colonoscopies at the trial endoscopy centers or at the cooperating referring endoscopy centers outside the study. patient will be scheduled for the index therapeutic colonoscopy (itc) and randomized in two groups - ftr group (therapy with ftrd) and st group (standard therapy, emr or esd due to the indication, decided by the endoscopist). first follow-up colonoscopy (fc1) will be performed in 6 months interval. in case of lrn negativity at fc1, the second follow-up colonoscopy (fc2) will be done after 12 months (18 months since itc). in case of lrn positivity at fc1, the lrn therapeutic colonoscopy (lrn-tc) will follow with the endoscopic method due the findings (patients will be divided into four groups): apc group (lrn ≤ 5 mm; apc therapy), emr group (lrn \> 5 mm and negative non-lifting sign negative; emr therapy), ftr group (lrn \> 5 mm and positive non-lifting sign; therapy with ftrd) and surgery group (complex lesion; surgical therapy). in some lrn positive cases, fc1 will be the same as lrn-tc. the first follow-up colonoscopy after lrn therapy (lrn-fc1) will be performed after 6 months (12 months since tc). in case of re-lrn negativity at lrn-fc1 the second follow-up colonoscopy after lrn therapy (lrn-fc2) will be done after 6 months (18 months since itc). in case of re-lrn positivity at lrn- fc1 the therapy will be done same as during fc1 and next follow-up will be done outside this trial. in some re-lrn positive cases, lrn-fc1 will be the same as re-lrn-tc. in conclusion, all patients will be followed-up within the study for 18 months, if timely possible.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * colorectal lesions of 10-25 mm size with positive non-lifting sign * signed informed consent with the study and with colonoscopy exclusion criteria: * age \< 18 years * lesions \> 25 mm * pedunculated polyps * colorectal stenosis * colonoscopy contraindication * severe acute inflammatory bowel disease * severe comorbidities * patient not able to sign the informed consent
study for the efficacy and security analysis in the protection of ileocolic anastomosis conducted in laparoscopic right hemicolectomy because of colon cancer, using a nhs-peg coated collagen patch.

Conditions: Adenocarcinoma Colon

Summary: the aim of this study is to analyse the effectiveness and security in the prevention of anastomotic leakage by protecting the ileocolic anastomosis with a reabsorbable nhs-peg collagen patch.


Eligibility criteria:
inclusion criteria: * ≥ 18 years old. * ability to understand and make their own decision to participate in the study. * pre-surgery right colon adenocarcinoma pathological diagnosis. * patient with a mechanic, intra or extracorporeal ileocolic anastomosis. exclusion criteria: * urgent intervention. * simultaneous colon cancer. * m1 pre-surgery staging.

Keywords: colon neoplasia ascendant colon surgical anastomosis anastomotic leak collagen polyethylene glycol hemopatch
bryostatin-1 effect on hiv-1 latency and reservoir in hiv-1 infected patients receiving antiretroviral treatment

Conditions: HIV Infection

Summary: phase i, randomized, double blind, placebo-controlled, dose-finding trial. the trial´s goal is to evaluate two different doses of bryostatin on hiv-1 latency and reservoir in hiv-1 infected patients receiving antiretroviral treatment.


Eligibility criteria:
inclusion criteria: * patients understanding the trial purpose * patients between 18 and 50 years of age * patients with chronic hiv-1 infection * patients receiving antiretroviral treatment with at least 3 active drugs for at least 2 years * undetectable viral load measured by ultra sensitive methods * cd4+ levels higher than 350 cells/mm3 * patients committed to use contraceptive methods during the trial and up to 3 months after. exclusion criteria: * previous antiretroviral treatment failure, as any viral load outbreak after having had undetectable hiv-1 load. low grade, transitory outbreaks (\<200 rna copies/ml) resolved without treatment modifications are excluded * patients planned to interrupt antiretroviral treatment during the trial * patients receiving immunosuppressant or immunostimulant drugs, including valproic acid. * pregnant women * bryostatin-1 hypersensitivity * being enrolled in another clinical trial or having participated in another clinical trial in the previous 3 months.

Keywords: hiv reservoir bryostatin
effects of early musical intervention on prevalence and severity of paroxysmal sympathetic hyperactivity after severe traumatic brain injury

Conditions: Paroxysmal Sympathetic Hyperactivity

Summary: paroxysmal sympathetic hyperactivity (psh) is a frequent symptom after traumatic brain injury and concerns up to 30% of severely brain-injured patients. psh is due to unbalanced autonomic nervous system activity, resulting in sympathetic surges causing hypertension, tachycardia, sweating and hypertonia. the affected patients suffer more pain, more cardiovascular distress, more infections and prolonged rehabilitation and mechanical ventilation; additionally it could lead to a worse outcome. classical music was shown to reduce autonomic nervous system imbalance in healthy people and in many medical diseases. it could be a means to dampen sympathetic surges for brain-injured patients presenting with psh, as well. our study aims at demonstrating that early musical intervention, started with the weaning of sedation, can reduce both the prevalence and the severity of paroxysmal sympathetic hyperactivity in traumatic brain-injured patients.


Eligibility criteria:
inclusion criteria: * severe traumatic brain injury (either initial glasgow coma scale \ 20mmhg for more than 20 min) * national health service coverage * informed consent signed by next of kin exclusion criteria: * non-traumatic brain injury * conditions interfering with measures: bilateral fixed pupils, temporal bone fracture including acoustic channel, eye trauma, previous eye surgery, otorrhagia, hypoacusis, * preexisting autonomic nervous system imbalance: severe diabetes, arrhythmias, pace maker, implantable defibrillator, cardiac transplantation * respiratory rate \< 9/min * patient subject to guardianship or wardship * pregnant or breastfeeding woman * current participation in another biomedical research protocol

Keywords: music therapy paroxysmal sympathetic hyperactivity traumatic brain injury
prostate cancer screening among men with high risk genetic predisposition

Conditions: BRCA1 Syndrome; BRCA2 Syndrome; Lynch Syndrome

Summary: this will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition.

this will be a prospective diagnostic trial of screening for prostate cancer among men with genetic predisposition. the target population is males (40-70 year old) carrying a brca1 and/or brca2 germ line mutation. they will be identified via our genetic counseling unit. all men after signing an informed consent will undergo the following tests: psa, free to total psa, mri of prostate and prostate biopsy. the primary endpoint will be to estimate the prevalence, stage and grade of prostate cancer in this population. additionally, the study aims to estimate the impact of these germ line mutations on benign prostatic hyperplasia. furthermore, this study aims to create a bio-bank of tissue, urine and serum of this unique cohort for future investigations. finally, this study will identify an inception cohort for future interventional studies of primary and secondary prevention.

Eligibility criteria:
inclusion criteria: * male carrier of mutation in brca 1\\2 or germ-line mutations in the mmr genes (mlh1, msh2 , msh6 or pms2). * who performance status 0-2 (appendix 2) * absence of any psychological, familial, sociological or geographical situation potentially hampering compliance with the study protocol and follow-up schedule. * individuals that cannot undergo the mri exam due to high creatinine level or claustrophobic will be disc loud from the mri part. * informed written consent must be sought according to ich/eu gcp, before subject registration. exclusion criteria: * previous cancer with a terminal prognosis of less than five years. * previous prostate cancer

Keywords: prostate cancer brca1 syndrome brca germ-line mutation lynch syndrome brca2 syndrome
comprehensive protocol for treatment of upper limb spasticity in post-stroke hemiplegic patients

Conditions: Post-stroke Upper Limb Spasticity

Summary: the general objective of this study was to evaluate the efficacy of the comprehensive protocol in improving post-stroke upper limb spasticity. the specific objectives were to evaluate pain improvement and changes in quality of life and functional capacity in patients who were subjected to the comprehensive protocol compared with those in the patients who underwent sham interventions.

background: managing post-stroke upper limb spasticity is a major challenge in the rehabilitation field. the objective of this study was to evaluate the efficacy of a comprehensive treatment protocol with four therapeutic modalities in the recovery of patients with chronic stroke by evaluating clinical, neurological and functional outcomes. methodology: thirty-two subjects diagnosed with a stroke at least six months prior to the study were randomized to receive ten sessions of either the treatment protocol or a sham intervention. the treatment protocol consisted of transcranial low-frequency electrical stimulation using subcutaneous needles over the scalp, paraspinous blocks, spastic muscle needling and functional electrical stimulation. spasticity, range of motion, pain, functionality and quality of life were evaluated.

Eligibility criteria:
inclusion criteria: * age older than 18 years; * diagnosis of ischemic or hemorrhagic stroke at least six months previously; * presence of single upper limb spasticity exclusion criteria: * spasticity due to conditions other than stroke; * hypersensitivity to lidocaine; * use of cardiac pacemakers; * presence of coagulation disturbances; * insufficient perceptual and cognitive capacity to understand the proposed treatment and answer the questionnaires

Keywords: muscle spasticity stroke stroke rehabilitation nerve block dry needling transcranial direct current stimulation electric stimulation therapy