Kornimate/medical-research-clean huggingface dataset:
glue embolization vs conservative treatment for pelvic congestion syndrome

Conditions: Glue Embolization; Pelvic Congestion Syndrome

Summary: the aim of this study is to compare glue embolization and conservative treatment for pelvic congestion syndrome regarding safety and efficacy.

pelvic congestion syndrome (pcs) is a common cause of chronic lower abdominal/pelvic pain, estimated to affect about 40 % of women, predominantly between the ages of 30 and 45.the treatment of pcs depends mainly on the severity of the pain. non-steroid anti-inflammatory drugs are often used, and contraceptives have a role in cases of pain associated predominantly with menstruation. traditionally, conservative approaches, such as pharmacotherapy with venoactive drugs like micronized purified flavonoid fraction (daflon), have been utilized to address the symptoms of pcs. daflon has been used to treat venous insufficiency and has demonstrated efficacy in reducing symptoms and improving the quality of life in patients with pcs. its mechanism of action includes improving venous tone, reducing venous stasis, and exerting anti-inflammatory effects. endovascular treatment of pcs is challenging and requires occlusion of incompetent pelvic veins.

Eligibility criteria:
inclusion criteria: * women aged from 30 to 50 years. * complaining from pelvic congestion syndrome. exclusion criteria: * pregnant women at any gestational age, women who gave birth less than 12 months ago, and breastfeeding mothers. * patients who are treated with opiates to reduce pelvic pain in the period before the study. * patient with history of contrast allergy * patient with renal impairment * patient has alternative gynecological cause of chronic pelvic pain as pelvic inflammatory disease (pid), endometriosis, fibroid, adenomyosis, ovarian cyst * patient underwent any previous intervention for pelvic congestion syndrome as laparoscopy or surgery.
family-centered round in neonatology

Conditions: Prematurity

Summary: the family-centered care is based on dignity and respect, information sharing, collaboration and participation in care and decision-making. in a neonatal unit, the medical round by the attending physician is an important moment for shairing information with the medical and nursing staff and for the decision making process. in france, parents are rarely actively involved in the medical round. the aim of this study is to plan the implantation of the family-centered round in a neonatal department using the 6 steps of the "intervention mapping": 1/needs assessment; 2/ performance and change objectives; 3/ theory-based framework; curriculum development; 5- adoption and implementation; 6- evaluation and dissemination


Eligibility criteria:
parents group: inclusion criteria: * french speaking * voluntary to participate * parents of an hospitalized newborn exclusion criteria: * not fluent in french speaking * mental health problems professional group: * any staff member * voluntary to participate

Keywords: newborn preterm medical round family-centered care nicu
saliva testosterone increases in irritable bowel syndrome (ibs) patients beginning choir singing

Conditions: Irritable Bowel Syndrome

Summary: the hypothesis was that a one-year experience of choir singing once a week is more beneficial than group discussions to saliva concentration of testosterone.

the project aimed to study the health effects of regular choir singing for persons who are in a psychosomatic condition (irritable bowel syndrome - ibs). a group of ibs patients were randomized to choir singing or an information group were followed during one year with biological and psychosocial assessments. the choir group participated in various relaxation, breathing and vocal exercises with the choir leader, and received the material "to live with ibs" for home studies. at the same time a comparison group with ibs patients meet in groups, studying and discussing on the same materials under the direction of a group leader. both groups meet once per week.

Eligibility criteria:
inclusion criteria: * ibs according to physician certificates. * wish to start choir singing but no such experience during past ten years. * acceptance of randomisation condition. exclusion criteria: * no serious somatic diseases. * no abuse of alcohol or drugs. * no ongoing acute psychiatric condition.
study of the usefulness of the probiotic 'lactobacillus reuteri' in the therapy of quadruple eradication of helicobacter pylori infection in usual clinical practice.

Conditions: Helicobacter Pylori Infection

Summary: helicobacter pylori is a gram-negative bacterium with a helical bacillus shape that it's able to penetrate and colonize the stomach mucosal lining by infecting it. the eradication treatment of h. pylori is supported by numerous consensus groups worldwide and it is generally safe and well tolerated. standard treatment is based on multiple drug regimens. however, its effectiveness has been increasingly compromised due to the emergence of resistant strains, as well as poor adherence to treatment. therefore, it's proposed a randomized, double-blind, placebo-controlled study whose aims are: 1. determine whether the combination of two probiotic strains of l reuteri (gastrus) will improve gastrointestinal symptoms when associated with four-way therapy (of any type). 2. prove whether supplementation with gastrus (food supplement) versus placebo is able to reduce the gastrointestinal adverse effects of quadruple eradication therapy. they will be determined by the gsrs gastrointestinal symptom scale in routine clinical practice.


Eligibility criteria:
inclusion criteria: * patients attended at the clinic visit who present a positive diagnosis of h pylori infection using different diagnostic techniques (c13 breath test, histology, urease and / or h pylori antigen in stools). * age between 18 and 65 years exclusion criteria: * patients taking other probiotics 4 weeks prior to study start. * patients who have previously received eradicating therapy. * patients who are treated with nsaids, aspirin or other anti-inflammatory drugs either on an occasional basis (one week prior to the study) or on a chronic basis (3 weeks prior to inclusion). * patients who have used oral antibiotics two weeks prior to inclusion. * pregnancy
omalizumab treatment in venom immunotherapy with systemic reactions

Conditions: Allergy; Bee Venom; Immunotherapy; Omalizumab

Summary: the purpose of this study is to evaluate if omalizumab co-treatment may allow reintroduction of honey bee venom immunotherapy in patients with immunotherapy treatment failure due to systemic reactions.

some honey bee venom allergic patients cannot be treated with venom immunotherapy due to systemic reactions during immunotherapy - immunotherapy failure due to systemic reactions. high basophil allergen sensitivity is a risk factor for venom immunotherapy failure due to systemic reactions. omalizumab decreases basophil sensitivity. venom immunotherapy failure patients will be co-treated with omalizumab during another attempt of immunotherapy introduction. patients will be clinically and immunologically followed up after the introduction.

Eligibility criteria:
inclusion criteria: * severe anaphylactic reaction after honey-bee sting (mueller grade iii or iv) confirmed sensitization to honey-bee venom, * honey-bee venom immunotherapy treatment failure due to systemic reactions. exclusion criteria: * systemic mastocytosis, * pregnancy, * use of beta-adrenergic blocking agents.
heart rate variability assessment in dialysis patients by acupuncture

Conditions: RLS

Summary: title of the study:heart rate variability assessment in dialysis patients by acupuncture study period: 08/2019 - 07/2021 institution: the graduate institute of chinese medical science, china medical university/ changhua christian hospital,taiwan aim of the study: to investigate the effect of medical acupuncture in comparison to placebo acupuncture by heart rate variability(hrv) design: prospective randomized trial intervention: experiment group using indwelling fixed needles, n=30 ; control group using placebo needles, n=30 outcome measures: international rls rating scale, hrv

rls occurs in 3-15% of the general population and in 10-30% of patients on maintenance dialysis. end-stage renal disease, a decrease in hrv is typically found, with abnormal hrv being considered an independent risk factor for mortality.while the majority of studies show an initial improvement in symptoms, longer studies and clinical experience show that either treatment efficacy decreases with time, and/or augmentation develops: dopaminergic augmentation has been reported to be the main reason for treatment discontinuation and treatment failure in rls/wed. the study randomly assigned to either true acupuncture treatment or placebo/sham acupuncture treatment. each participant will undergo 12 treatments third-weekly, for a period of 4 weeks. at the end of the eighth treatment session, each participant will again fill out a irlsrs questionnaire ,isi and hrv test. at the end of the treatment regimen and 5weeks, participants will again fill out a irlsrs questionnaire ,isi and hrv test.

Eligibility criteria:
inclusion criteria: * dialysis patients with rls * the symptoms expressed ≧ 3 months and more than twice per week. * a score of at least 20 corresponding to severe rls ( international restless legs syndrome rating scale, irlsrs).dialysis patients with rls exclusion criteria: * idiopathic rls * other movement disorders, various psychiatric and organic disorders, cognitive impairment, or bleeding disorders, on anticoagulant therapy, or cardiac pacemaker.
holep vs bipolep in management of bph patients with large prostates

Conditions: Benign Prostatic Hyperplasia

Summary: this is a non-inferiority prospective randomized comparative clinical trial aiming to prove the non-inferiority of bipolar enucleation of the prostate in comparison to holmium laser enucleation of the prostate in management of benign prostatic hyperplasia patients with large prostates and in turn its feasibility as an alternative procedure in hospitals with limited resources

benign prostatic hyperplasia (bph) is a prevalent condition among older men. it is characterized by non-cancerous enlargement of the prostate gland often leading to urinary obstruction and significant morbidity. in case of failure of medical treatment, surgical intervention is often required especially in patients with larger prostates. surgical options in such cases include holmium laser enucleation of the prostate (holep) and bipolar enucleation of the prostate (bipolep). these modalities have emerged as promising relatively minimally invasive treatment options in patients with large prostates. holep, utilizing laser technology to enucleate prostatic tissue, has been associated with reduced intraoperative blood loss, shorter catheterization time, and quicker recovery in comparison to open prostatectomy. likewise, bipolep, utilizing bipolar energy for enucleation, offers the advantage of reduced bleeding and shorter operative time. both holep and bipolep have demonstrated efficacy in improving lower urinary tract symptoms (luts) and alleviating obstruction in bph patients with large prostates, but the comparative efficacy and safety of both techniques remains highly debated. this study aims to compare the efficacy and safety of these two surgical modalities aiming to provide valuable insights that can enhance clinical decision-making and patient care in bph management.

Eligibility criteria:
inclusion criteria: * age \>50 years * prostate volume \>80 ml * failure of or noncompliance with medical treatment * ipss \>15 * qmax \<15 ml/sec * urinary retention and fixed catheters with poor results on trial of voiding without catheter exclusion criteria: * patients with active uti * prostate cancer * bladder carcinoma * urethral stricture * neurogenic bladder disorders * redo cases

Keywords: holmium laser enucleation of prostate (holep) benign prostatic hyperplasia (bph) bipolar enucleation of prostate (bipolep)
"vibes"--low magnitude mechanical stimulation to improve bone mineral density

Conditions: Osteopenia

Summary: the purpose of this study is to determine if daily low magnitude, high frequency whole body vibration can improve bone density in seniors.

the treatment options for osteoporosis, a major health complication in the aged population, are limited to pharmacologic interventions, the majority of which are antiresorptive. preliminary data demonstrate that high frequency, low magnitude mechanical stimulation (lmms) can preserve bone mineral density (bmd) by preventing bone resorption due to disuse and aging, and can stimulate new bone formation. to confirm and extend these observations, this study is a three-year, double-blind, randomized, placebo-controlled clinical trial of lmms in 200 elderly women and men (60 years of age and older). a clinical center located in boston, ma has recruited participants from multiple independent living facilities in close geographic proximity. participants meeting the inclusion/exclusion criteria have been randomized to either brief daily exposure to lmms on a vibrating platform or a placebo platform over a three year period. all participants receive 1000 mg of elemental calcium and 800 iu of vitamin d per day. this study will provide new and important information about the role of low magnitude high frequency mechanical stimulation on the skeleton.

Eligibility criteria:
inclusion criteria: * men and women 60 years and over of all ethnic groups * weight less than 250 pounds * absence of terminal cancer or other illness necessitating hospice level services * capable of following the protocol and of understanding and providing informed consent * scoring less than 12 on the short blessed test exclusion criteria: * immobilization of the axial or lower appendicular skeleton within the last year * nonambulatory (ambulation with an assistive device will be permitted) * malignancy other than cured thyroid cancer or skin cancer * hip replacement or internal fixation, total knee replacement, or lower limb fracture within the past year, or bilateral hip replacement * medications: glucocorticoids, suppressive doses of thyroid hormone as determined by screening tsh, anticonvulsant drugs (phenytoin, phenobarbital, carbamazepine), estrogen/testosterone replacement, selective estrogen receptor modulators (serms), pth, or bisphosphonates more than 1 month in past year, calcitonin therapy within the preceding month, fluoride therapy at any time * paget's disease of bone, rheumatoid arthritis or other connective tissue disorders requiring systemic treatment with disease modifying drugs, or a history of cushing's syndrome * fragility fracture within the past five years unless pharmacologic therapy not to be prescribed

Keywords: biomechanics osteogenesis osteoporosis bone regeneration
study to evaluate the safety and efficacy of gabitril treatment in adults with generalized anxiety disorder.

Conditions: Anxiety Disorders

Summary: a 12-month, open-label, flexible-dosage study to evaluate the safety and efficacy of gabitril treatment in adults with generalized anxiety disorder.


Eligibility criteria:
subjects who have completed 10 weeks of double-blind treatment and the subsequent taper period in 1 of the 3 previous double-blind studies (studies c6671/3030/ax/us, c6671/3031/ax/us, or c6671/3032/ax/us).
expanded access for khk2455

Conditions: Glioblastoma Multiforme

Summary: this is an expanded access program for eligible participants. this program is designed to provide access to khk2455 in combination with mogamulizumab prior to the approval by the local regulatory agency. a medical doctor must decide whether the potential benefit outweighs the risk of receiving this investigational therapy based on the individual patients medical history and eligibility criteria.


Eligibility criteria:
inclusion criteria: - exclusion criteria: -
long term effect of aggressive nutritional management on survival in patients with alcoholic liver disease

Conditions: Alcoholic Liver Disease

Summary: patient found to be malnourished after the nutritional evaluation would be randomized in the two groups of the study. the control group would receive standard nutritional counseling from a trained dietician where as those in the intervention group would be given 120 gm of a polymeric nutritional supplement providing around 500 kcal per day over and above the standard nutritional counseling from a trained dietician. both the groups would receive standard medical treatment. the polymeric nutrient supplement would be taken by the patients in this arm for a period of 6 months.

patients with ald (alcoholic liver disease) would undergo a detailed clinical evaluation. information would be collected regarding the onset and duration of symptoms, etiology, and severity of disease, other baseline clinical features, demographic characteristics, routine biochemical and hematological investigations, upper gi endoscopic findings and radiological investigations, patients would also be screened for the assessment of nutritional status. patient found to be malnourished after the nutritional evaluation would be randomized in the two groups of the study. the control group would receive standard nutritional counseling from a trained dietician where as those in the intervention group would be given 120 gm of a polymeric nutritional supplement providing around 500 kcal per day over and above the standard nutritional counseling from a trained dietician. both the groups would receive standard medical treatment. the polymeric nutrient supplement would be taken by the patients in this arm for a period of 6 months. a record would be kept for the medications taken by the patients. all the patients would be followed up at 1 week, 2 weeks, 3 weeks, 1 month, 2 months, 3 months, 6 months, and 1 year after inclusion. clinical, nutritional and biological data were collected at each visit. all these patients would receive standard treatment of cirrhosis consisting of withdrawal from alcohol along with symptomatic treatment including b vitamins, diuretics, salt restriction, lactulose, beta blockers, and antibiotics after bacteriological samples if needed. all patients would receive endoscopic surveillance for portal hypertension. an adequate prophylaxis by ligation or beta blockers would be performed as needed. the patients with a past history of spontaneous bacterial peritonitis will receive antibiotic prophylaxis.

Eligibility criteria:
inclusion criteria: * all consecutive malnourished patients with ald aged between 18 to 65 years of either gender would be enrolled. * abstinence of three months. exclusion criteria: * severe alcoholic hepatitis * uncontrolled complication of the cirrhosis (variceal bleeding, infection, etc.), * hepatocellular carcinoma * ongoing corticosteroid treatment * co morbidities e.g. chronic renal insufficiency \& acquired immunodeficiency syndrome. * refusal to participate in the trial
no more sleepless nights in perimenopause

Conditions: Insomnia; Menopause

Summary: the goal of the clinical trial is to learn if hormone replacement therapy (hrt) and cognitive behavioral therapy (cbt-i) can treat insomnia in menopausal women. the main questions it aims to answer are: * are hrt and cbt-i effective in reducing insomnia in menopausal women? * are hrt and cbt-i comparable in terms of reducing insomnia severity in this population? researchers will compare hrt and cbt-i to an active control group, receiving sleep hygiene instructions. participants will: * complete a screening and baseline assessment * receive hormone replacement therapy (as prescribed), cognitive behavioral therapy (1/week), or sleep hygiene instructions (1/week) for 8 weeks. * keep a daily diary (sleep e-diary), to assess sleep-quality. * wear an electroencephalogram (eeg) during 6 nights (3 at baseline \& 3 post-intervention), to assess deep sleep cycles and waking episodes. * receive a phone call for intervention compliance * complete a post-intervention assessment.


Eligibility criteria:
inclusion criteria: * late menopausal transition according to stages of reproductive aging criteria (straw+10) * pittsburgh sleep quality index (psqi) score \> 5 * insomnia severity index (isi) score \> 7 * somato-vegetative domain of the menopause rating scale (mrs)-ii ≥ 4 points * willingness to use hrt for menopausal symptom reliefs exclusion criteria: * other sleep-wake disorders according to dsm-5, assessed with validated questionnaires (sleep-health questionnaire, epworth sleepiness scale (ess)) * untreated hormonal disorder * obesity (bmi ≥ 30) * current psychotherapy * current psychopharmacological therapy including regular sleep medication * history of unsuccessful cbt-i * psychiatric illness * substance abuse (≥ 7 cigarettes/day, no more than 2 standard who drinks per day, other drugs) * shift work * long-haul flights across different time zones in the past 3 months * pregnancy and lactation * contraindications to hrt according to drug information (https://www.swissmedicinfo.ch/) * inability to follow procedures or insufficient knowledge of project language * inability to give consent

Keywords: perimenopause insomnia cognitive behavioral therapy hormone replacement therapy
the effect of music on the sedation quality among children in the emergency department.

Conditions: Sedation

Summary: children presenting to the emergency department frequently experience anxiety and may undergo various painful procedures. while sedative agents are administered to these patients, they do not consistently provide adequate relief to keep the child calm and cooperative during the procedures. implementing non-pharmacological interventions, such as music, might enhance the efficacy of sedation, resulting in a better experience for these patients and more favorable outcomes.

this is an interventional single-blinded randomized clinical trial on children presenting to the emergency department of imam khomeini hospital in tehran. the estimated sample size is 42 patients in each group considering a 5% margin of error and 80% power. the efficacy of analgesia and sedation and adverse effects are measured using a predefined form. for the description of qualitative data, frequency will be used and for quantitative data, the t-test, anova, mean and sd will be employed. for examining differences between the two groups, chi-square, t-test, and anova will be utilized.

Eligibility criteria:
inclusion criteria: * children between 0-14 years of age * requiring analgesia or sedation for medical procedures exclusion criteria: * lack of consent from parents or legal guardian of the child * hearing impairment * any developmental disorder