Kornimate/medical-research-clean huggingface dataset:
exercises to enhance uterus involution

Conditions: Uterus Involution

Summary: the goal of this randomized controlled study was to compare the effect of aerobic exercise and pelvic floor muscle strengthening exercises on uterus involution. in the scope of study following questions will be answered at the end of the study. first which of the exercise type is more effective to enhance uterus involution? secondly, does exercises induce changes in lactation rate during the study period? thirdly, does exercises improve the experienced pain? study will be consisted of three groups as control group, pelvic floor exercise group and aerobic exercise group. control group will take routine gynaecological treatment. pelvic floor muscle strengthening exercise group will attend to seven day pelvic floor strengthening exercise programme. aerobic exercise group will attend to seven day aerobic exercise programme consisting of walking.

a total of 45 mothers who satisfies the eligibility criteria of the study will be recruited to the study. following to the recruitment process mothers will be randomly assigned to the one of the three groups. mothers in the control group will only take routine gynecologic treatment. mothers in the aerobic exercise group will attend to aerobic exercises starting from the second day of the hospitalization for one week. mothers who will be in pelvic floor strengthening exercise group after the randomization will be asked to perform six exercises with moderate difficulty that are recommended by the national association for incontinence.

Eligibility criteria:
inclusion criteria: * age of 19 to 35 years * new born apgar score is equal or higher than 8 * first pregnancy * giving birth in 37th to 40th weeks of the pregnancy * birthweight ranging from 2500 g to 4000 g exclusion criteria: * eclampsia * puerperal psychosis * severe preeclampsia * multiple pregnancy story * uterus abnormality story * uterus surgery story * use of artificial estrogen * existence of systemic, mental or pregnancy related diseases * occurrence of complication during or after the pregnancy * symptoms of uterus subinvolution

Keywords: lactation pregnancy pelvic floor pain
neurocytotron on cerebral palsy

Conditions: Cerebral Palsy

Summary: this is a randomized, double-blinded, two-arm, placebo-controlled clinical study. the enrollment will be randomized 1:1 to neurocytotron treatment or mock treatment (placebo). upon the completion of the study period, the placebo group will receive treatment, if the study results show benefits to patients.

the study proposes to investigate the use of non-thermal and non-radioactive radiofrequency pulses in the brain for improving the symptoms of cerebral palsy. the proposed treatment will deliver radiofrequency pulses to the brain of patients in a non-invasive manner. the duration of the treatment will be 1 hour per day, for 28 days. after treatment, participants will be monitored for two months to detect potential adverse events and any signs of symptoms improvement. the study will be closed once 48 subjects complete the study. at the end of the study, the placebo group will have the opportunity to receive treatment with the neurocytotron, based on the benefits shown by study results.

Eligibility criteria:
inclusion criteria: 1. informed consent form approved by the institutional review board (irb)/independent ethics committee (iec) signed and dated by the subject or the subject's legal representative and by the principal investigator. this must be obtained before the performance of any study-related procedures that are not part of normal participant care. 2. patients 1 to 8 years old (we will include this age range because children with cp less than 1-year-old have a high mortality rate, in addition, the clinical evolution stabilizes after the second year of life, and the potential effect of treatment is optimized in the first 5 years). 3. a clinical diagnosis of spastic cerebral palsy, or spastic and dyskinetic, secondary only to hypoxic/ischemic encephalopathy 4. for spasticity, having scored at least 3 on the ashworth scale, and 3 on the gross motor scale. 5. for dyskinesis, any degree. exclusion criteria: 1. patient with diagnosis of ataxia. 2. current or recent history (within 2 months) of significant bacterial, fungal, viral, or mycobacterial infection. 3. having a condition considered as causing or likely to cause co-morbidities, as determined by the investigator based on medical history, physical examination, vital signs, and clinical laboratory tests. 4. subject with magnetic implants, pacemakers, claustrophobia or any other condition that precludes them from entering or staying in the neurocytotron. 5. surgical history related to spasticity treatment. 6. patients who have received treatment with botulinum toxin in the last 6 months. 7. 7. children with prior neurosurgery within the past 6 months at the time of evaluation. 8. history of malignancy. 9. history of congenital heart disease. 10. subjects who cannot or are unlikely able to comply with the protocol, according to the consensus reached by the group of study investigators.
ponto implantation using a minimally invasive surgical technique

Conditions: Hearing Loss

Summary: this multi-centre study funded by oticon medical ab will be conducted at seven hospitals across europe (uk, sweden, denmark and the netherlands). in total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (bahs) will be included in the study. the purpose of the study is to investigate the rate of successful bahs use after implantation of the ponto implant system using a minimally invasive surgical technique.

this multi-centre study funded by oticon medical ab will be conducted at seven hospitals across europe (uk, sweden, denmark and the netherlands). in total, 50 adult patients with a hearing loss that are already planned for treatment with a percutaneous (through the skin) bone-anchored hearing system (bahs) will be included in the study. the purpose of the study is to investigate the rate of successful bahs use after implantation of the ponto implant system using a minimally invasive surgical technique. the implant, coupled to a skin-penetrating abutment, is implanted in the bone behind the ear and is later loaded with a sound processor which transforms sound waves to sound vibrations that can be sent directly to the inner ear via the skull bone. the primary objective of this study is to investigate the proportion of implant/abutment complexes providing a reliable anchorage for a sound processor three months after implantation/surgery.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * patient indicated for surgical intervention with a bone anchored hearing system * signed informed consent * adequate bone quality to allow for a ponto implant insertion, as judged by the investigator, and an expected bone thickness above 5 mm, where no complications during surgery are expected * skin thickness of 12 mm or less at the implant site exclusion criteria: * patient undergoing re-implantation * patient who are unable or unwilling to follow investigational procedures/requirements, e.g. to complete quality of life scales * known condition or previous treatment that could jeopardize skin condition and wound healing over time as judged by the investigator (e.g. uncontrolled diabetes, previous radiotherapy in the area of interest) * known medical condition that contraindicate surgery as judged by the investigator * known and/or planned pregnancy at time of surgery * any other known condition that the investigator determines could interfere with compliance or investigation assessments * simultaneous participation in another clinical investigation with pharmaceutical and/or medical device which might cause interference with investigation participation
auriculotherapy in the treatment of dysmenorrhea

Conditions: Primary Dysmenorrhea

Summary: this study aims to determine if auriculotherapy is effective in the treatment of dysmenorrhoea. this intervention consists of fixation of yellow mustard seeds at specific points of the auricular pavilion (or area), with opaque tape. half of the participants will have specific ear pinch points stimulated by mustard seeds fixed with opaque plaster, while the other half will have only the adhesive plasters fixed, without the seeds for stimulation.

primary dysmenorrhoea is responsible for the most part of dissatisfactions in the female class, in the face of discomforts which are caused monthly. for this, the income index of this woman in the work environment tends to reduce, thus harming the development of every sector to which she responds. the expected effects, after the intervention, will be positive, favoring a considerable improvement of the symptoms reported by the women. we chose auriculotherapy because it is a non-medicated, noninvasive intervention that is inexpensive.

Eligibility criteria:
inclusion criteria: * to be eligible to participate in this study, the individual must meet the following criteria: * free and informed consent form, duly signed and dated * consent to voluntarily participate in all study procedures and availability for the duration of the study * female subjects * age above of 18 years old * enjoy good general health * have active menstrual cycle * complaint about dysmenorrhea exclusion criteria: * an individual who meets any of the following criteria will be excluded from participation in this study: * clinical diagnosis of endometriosis * myomas * pelvic inflammatory disease * adenomyosis * in the active phase for treatment of cancer (chemotherapy or radiotherapy) * women who are already in menopause * pregnancy

Keywords: dysmenorrhea acupuncture auriculotherapy
jc-virus (jcv) antibody program

Conditions: Multiple Sclerosis

Summary: the primary objective is to define the prevalence of serum anti-jcv antibody in relapsing multiple sclerosis (ms) participants receiving tysabri® (natalizumab) or being considered for such treatment. secondary objectives are to analytically validate the anti-jcv antibody assay in a plasma matrix and to determine changes in anti-jcv antibody status over time.

this study requires serum, plasma and urine collection at enrollment and every 6 months thereafter for up two years.

Eligibility criteria:
key inclusion criteria: * relapsing multiple sclerosis (ms) patients interested in or considering beginning treatment with tysabri® (natalizumab). key exclusion criteria: * patients participating in any other tysabri® (natalizumab) clinical trial or study sponsored by biogen idec or elan may not participate in this study. note: other protocol-defined inclusion/exclusion criteria may apply.

Keywords: sample collection jcv pml
prospective evaluation of 14f thal tube vs 28 french chest tube for hemothorax and use of maximum barrier precautions

Conditions: Hemothorax; Hemopneumothorax; Traumatic; Empyema; Chest Tube Size

Summary: traumatic hemothorax and hemopneumothorax are common diagnoses which are typically treated by placement of a chest tube. 28-32 fr chest tubes have previously been shown equivalent to 36-40 fr chest tubes for the non-emergent drainage of hemothorax. a smaller study has found 14 fr pigtails had less pain than larger tubes but was not powered to compare outcomes. we seek to perform a prospective randomized trial that is adequately powered comparing efficacy of 14 fr thal tubes to 28 fr chest tubes for non-emergent drainage of hemothorax and hemopneumothorax. additionally, we will employ maximal barrier precautions for all chest tube insertions and compare empyema rates to our historical controls.


Eligibility criteria:
inclusion criteria: * the patient is admitted to the trauma service. * the patient has a hemothorax and/or or hemopneumothorax, requiring thoracostomy tube placement. * thoracostomy tube placement is able to be performed or witnessed by an investigator listed on the study. * the patient has not had a chest tube in the past year. * the patient is \>18 years of age. * in the event the patient is decisionally impaired, consent will be obtained from the individual's legally authorized representative (lar) or from the individual's healthcare power of attorney (hpa). * in the instance of reversible impairment, initial consent would be obtained from the lar/hpa and the patient will be approached for consent once he/she is deemed mentally competent by the care provider. exclusion criteria: * the patient is incarcerated * the patient is known to be pregnant * the patient is \< 18 years of age * the patient is hemodynamically unstable, requiring emergent chest tube placement (in \<10 minutes from evaluation).

Keywords: chest tube size hemothorax empyema
endocrine therapy with or without cryoablation for stage iv prostate cancer

Conditions: Stage IV Prostate Cancer

Summary: this trial is going to evaluate tumor control and quality of life in patients with prostate cancer treated with endocrine therapy with or without cryoablation.

objectives: * to determine the tumor control in patients with prostate cancer treated with radiotherapy or cryoablation * to determine the quality of life of these patients. outline: this is a multicenter study. patients are stratified according to gleason score (≥ 8 vs 7 vs ≤ 6), persistent prostatic specific antigen (psa) at allocation (\> 0.5 ng/ml vs ≤ 0.5 ng/ml), participating center. patient are allocated to two treatment arms.

Eligibility criteria:
inclusion criteria: * prostate adenocarcinoma, t4n0m0, any t with n+ or m+ * previously untreated disease or undergone endocrine therapy without reaching to castration resistant prostate cancer * survival ≥ 12 months * who performance status 0-2 * white blood cell ≥ 3.5 ×10\*9/l * platelets ≥ 5×10\*9/l * hemoglobin ≥ 10 g/dl exclusion criteria: * history of malignant disease * history of coronary artery disease * uncontrolled infection * other concurrent severe or uncontrolled medical disease that could compromise participation in the study (i.e., uncontrolled diabetes mellitus, uncontrolled cardiac disease, uncontrolled hypertension, congestive cardiac failure, ventricular arrhythmias, active ischemic heart disease, myocardial infarction within the past six months, chronic liver or renal disease, and active upper gastrointestinal tract ulceration) * psychological, familial, sociological, or geographical condition potentially hampering compliance with the study treatment and follow-up schedule
a minimally-invasive sponge on a string device for screening for barrett's esophagus

Conditions: Barrett Esophagus

Summary: this study is being done to collect data on the potential use of a sponge on a string device as a non-invasive tool in evaluating patients with barrett's esophagus compared to healthy controls.

this study will be conducted in two phases: phase 1 and phase 2. phase 1 will consist of determining the most optimal sponge on a string design (25 mm sponge 20 pores/inch or 25 mm sponge 10 pores/inch) chosen based on participant acceptance, tolerability, mucosal irritation and dna yield, using a randomized factorial design pilot trial. participants will first undergo the sponge on a string test followed by clinical endoscopy. following completion of phase 1 trial, the most optimal sponge on a string configuration will be chosen for phase 2. phase 2 will be conducted using a single size sponge with the same porosity configuration selected from phase 1. study procedures, testing and follow up will be the same as phase 1.

Eligibility criteria:
inclusion criteria: subjects with known barrett's esophagus (be). * patients with a be segment ≥ 1cm in maximal extent endoscopically. * histology showing evidence of intestinal metaplasia with or without presence of dysplasia. * undergoing clinically indicated endoscopy. subjects without known evidence of be - undergoing clinically indicated diagnostic endoscopy exclusion criteria: * subjects with known be. * patients with prior history of ablation (photodynamic therapy, radiofrequency ablation, cryotherapy, argon plasma coagulation). patients with history of endoscopic mucosal resection alone will not be excluded. * patients with history of esophageal resection for esophageal carcinoma. subjects with or without known evidence of be (on history or review of medical records). * pregnant or lactating females. * patients who are unable to consent. * patients with current history of eosinophilic esophagitis, achalasia or uninvestigated dysphagia. * patients on oral anticoagulation including coumadin, warfarin. * patients on antiplatelet agents including clopidogrel, unless discontinued for 3 days prior to the sponge procedure. * patients on oral thrombin inhibitors including dabigatran and oral factor x a inhibitors such as rivaroxaban, apixaban and edoxaban, unless discontinued for 3 days prior to the sponge procedure. * patients with history of known varices or cirrhosis. * patients with history of esophageal resection for esophageal carcinoma. * patients with congenital or acquired bleeding diatheses. * patients with a history of esophageal squamous dysplasia. * patient has known carcinoma of the foregut (pancreatic, bile duct, ampullary, stomach, or duodenum) within 5 years prior to study enrollment.

Keywords: barrett's esophagus reflux esophageal adenocarcinoma
dapagliflozin effect on rheumatic mitral stenosis

Conditions: Rheumatic Heart Disease; Heart Failure; Mitral Stenosis

Summary: rheumatic mitral stenosis remains a health problem in developing countries. progressive fibrosis of the valves and myocardium is the main pathophysiology that plays an important role. dapagliflozin has various beneficial effects on the heart by reducing fibrosis, reducing inflammation, and improving patient quality of life. however, the role of this therapy is unknown in patients with rheumatic mitral stenosis.

this study is an open-label study on rheumatic mitral stenosis patients, carried out at sebelas maret university hospital sukoharjo, panti rahayu hospital purwodadi, and permata bunda hospital purwodadi. researchers divided 36 rheumatic mitral stenosis patients sequentially into two groups, the first was the dapagliflozin group which would receive dapagliflozin 10 mg once a day and standard treatment. and the second group will only get standard treatment. each patient will be examined on picp, mmp-1, mmp-1/timp-1 ratio, tgf-β, net atrioventricular compliance index, nt-pro bnp, and kansas city cardiomyopathy questionnaire on day 1 and one month after the intervention.

Eligibility criteria:
inclusion criteria: * severe mitral stenosis by echocardiographic examination of the planimetric method with morphology that supports the etiology of rheumatic * heart failure in functional class ii-iii * dapagliflozin naive exception criteria: * other significant valve diseases * pregnant or breastfeeding * unstable hemodynamic conditions including cardiogenic shock * history of mitral valve replacement/repair or mitral balloon valvuloplasty * history of hypoglycemia * egfr below 25 mmhg * diffuse pulmonary fibrosis

Keywords: rheumatic heart disease mitral stenosis heart failure
study of the cyclopen micro-interventional system and long-term clinical outcomes

Conditions: Open Angle Glaucoma

Summary: this observational study will enroll adults with open angle glaucoma (oag) who had surgery to reduce intraocular pressure (iop) using the cyclopen micro-interventional system. consenting participants will be followed for 24 months after their surgery. data regarding iop, use of glaucoma medications, and any side effects related to the surgery will be collected from participants' preoperative examination, their surgery, and postoperative examinations.

this is a multicenter, observational registry of eligible adults with open angle glaucoma (oag) in whom iop-lowering surgery with the cyclopen micro-interventional system was performed are consecutively enrolled. data will be collected from the preoperative visit(s) that directly preceded surgery, the surgical procedure, and postoperative visits through 24 months after cyclopen system use. specific data to be collected includes details of the cyclopen surgical procedure, iop, use of ocular hypotensive medications, and any side effects related to the surgery.

Eligibility criteria:
to be included, participants must have: 1. open angle glaucoma 2. iop-lowering surgical procedure using the cyclopen system there are no exclusionary criteria.
stream-strategic reperfusion (with tenecteplase and antithrombotic treatment) early after myocardial infarction

Conditions: Myocardial Infarction

Summary: this study aims at evaluating, in a proof of concept approach, the outcome of patients presenting with acute st-elevation myocardial infarction within 3 hours of symptom onset in either a pre-hospital setting or community hospital emergency room without a pci facility. following randomisation a strategy of early tenecteplase and additional antiplatelet and antithrombin therapy followed by catheterisation within 6-24 hours with timely coronary intervention as appropriate (or by rescue coronary intervention if required) in group a will be compared to primary pci performed according to local standards in group b. the study is exploratory in nature and will examine this medical question. the efficacy and safety endpoints as well as mixed (efficacy and safety) composite endpoints up to or before 30 days following randomisation will be evaluated. all clinical endpoints of main interest will be assessed as single or composite endpoints for evaluation of the trial objective. all statistical tests are of exploratory nature based on descriptive p-values for formal statistical hypotheses generation.


Eligibility criteria:
inclusion criteria: 1. age equal or greater than 18 years 2. onset of symptoms \< 3 hours prior to randomisation 3.12-lead ecg indicative of an acute stemi 4.informed consent received exclusion criteria: medical history, procedures, medication administration or the presence of factors that would in general predispose to bleeding events and/or the inability to evaluate the study primary endpoint
effectiveness of a home-based rehabilitation program in stroke survivors using the euleria home® device

Conditions: Stroke; Telemedicine; Rehabilitation; Telerehabilitation

Summary: to verify the non-inferiority, in terms of post-treatment (t1) clinical effectiveness, of a "multidomain" telerehabilitation (tr) protocol compared to conventional outpatient rehabilitation in patients with stroke sequelae, with respect to motor, cognitive, and language functions. the absence of statistically significant differences between the two groups regarding treatment effects for each targeted domain will be considered an indicator of non-inferiority.


Eligibility criteria:
inclusion criteria: * age over 18 years. * first diagnosis of ischemic stroke, documented radiologically via ct or mri scans, corresponding to icd-9-cm codes 433 and 434 . * presence of aphasia, as assessed by the aachener aphasia test (aat), and/or cognitive deficits identified through the oxford cognitive screen (ocs). * availability of an adsl or higher-speed internet connection at the patient's residence. * ability of the patient and/or caregiver to understand and utilize the telerehabilitation system. * provision of written informed consent. exclusion criteria: * contemporanea partecipazione ad altri studi clinici; * decadimento cognitivo * deformità ossee come conseguenza di precedenti eventi traumatici ai 4 arti; * contratture fisse ai 4 arti valutate come 4/4 alla scala di ashworth modificata (mas) * altre patologie neurologiche e ortopediche in grado di interferire con lo studio.

Keywords: stroke telemedicine telerehabilitation motor cognitive