Kornimate/medical-research-clean huggingface dataset:
management of dysuria and irritative symptoms after holep: a prospective study evaluating the efficacy of alpha-blocker therapy

Conditions: Prostate Hyperplasia

Summary: holmium laser enucleation of the prostate (holep) is an increasingly popular endoscopic minimally invasive surgical technique for the treatment of benign prostatic hyperplasia (bph). in the literature, the long-term efficacy and low complication rates of holep have been highlighted in many studies. however, in the early postoperative period, particularly within the first three months, irritative symptoms are reported in 17-35% of cases (1-2). the pathophysiology of postoperative irritative symptoms is not yet fully understood, but it has been suggested that these symptoms may be associated with urethral trauma, the mucosal healing process, and detrusor overactivity. these symptoms can significantly impact quality of life, reducing patient satisfaction. in particular, dysuria is a frequently encountered symptom after holep, with considerable individual variability in its severity and duration. the effectiveness of alpha-blockers in alleviating postoperative dysuria and irritative symptoms remains a topic of debate in the literature. although prostate tissue is surgically removed, alpha-blockers may improve urinary flow and relieve symptoms associated with bladder outlet obstruction by reducing urethral smooth muscle tone (3). studies on the use of alpha-blockers following transurethral resection of the prostate (turp) have shown limited postoperative benefits (4). however, to the best of our knowledge, no study has specifically evaluated their use following holep, an enucleation-based technique. therefore, further studies are needed to assess the role of alpha-blockers in managing dysuria after holep. the aim of this study is to evaluate the effectiveness of alpha-blocker therapy in managing dysuria and other irritative symptoms following holep. additionally, the study seeks to determine the impact of this treatment on quality of life and patient satisfaction.


Eligibility criteria:
inclusion criteria: men over 40 years old, under 85 years old, and holep surgery exclusion criteria: prostate cancer, patients with bladder stones, patients with a history of urethral stricture, patients with detrusor underactivity in urodynamics, those who have had prostate surgery before
smart trial: community stigma reduction

Conditions: Opioid-use Disorder; Stigma, Social

Summary: the goal of this project is to engage community members from two low-income african american communities (n=200) in a survey study that assesses stigma toward those with opioid use disorder (oud). those from the intervention community will be subject to a stigma reduction campaign via billboards. those from the control community will not. stigma will be re-assessed following the period of the campaign.


Eligibility criteria:
inclusion criteria: * identify as african american or mixed race * reside in frayser or orange mound communities * access to telephone for follow-up assessment exclusion criteria: * unable to understand consent procedures

Keywords: stigma opioid use disorder community
teaching young children swim survival skills

Conditions: Drowning

Summary: this study is designed to evaluate whether commercially-available swim self-rescue schools are effective to teach children ages 12-23 months to stay safely alive floating in the water (or grasping the pool's edge) without adult intervention. the investigators will measure children's water self-rescue skills at baseline and then they will engage in commercially-available training over the course of several weeks. the investigators will then measure their skills again. assessments will be conducted using a standardized protocol with a certified lifeguard present. parents will also complete a short survey concerning child and family demographics and child and family swim and lifeguard training experience.


Eligibility criteria:
inclusion criteria: * child ages 12-23 months * enrolled in self-rescue course at participating swim facility exclusion criteria: * medical conditions counter-indicating training in water * previous experience in self-rescue swim courses
healthmap: an interactive health plan randomised trial to prevent cardiovascular disease in people with hiv

Conditions: HIV; Cardiovascular Disease

Summary: the purpose of this study is to improve the health status of people living with hiv in australia. the overall goal is to rigorously evaluate the impact of interactive health plans and self-management support on chronic condition outcomes in people with hiv. the specific aims are to: aim 1: using a doctor-level cluster randomised trial, evaluate the effect of interactive health plans and self-management support on coronary heart disease risk and other chronic condition outcomes in people living with hiv. aim 2: evaluate patient and health care provider experiences and acceptability of interactive health plans and self-management support. aim 3: evaluate intervention cost-effectiveness and effect on health service utilisation.

participants will be consenting adults 30 years or older without evidence of cardiovascular disease.the study is a pragmatic cluster randomized controlled trial of a complex health system intervention with doctor as the unit of randomization and individual patient outcomes defined as primary and secondary endpoints. the primary endpoint will be assessed in each participant after 12 months of follow up.the study intervention will consist of a programme specifically designed for the australian clinical context that helps people with hiv and their health care providers achieve best practice targets for modifiable cardiovascular risk factors. the programme will be available to use during routine consultations to present laboratory results, discuss health priorities and describe goals and actions. patients will be able to access the interactive health plan from home, with associated additional resources, including online peer support. phone and online health coaching will be available for prioritised patients wanting to reduce their cardiovascular risk. the primary objective is to determine the effect of the intervention on 10-year risk of non-fatal acute myocardial infarction or coronary heart disease death as estimated by the framingham risk equation. the secondary objective is to alternative cardiovascular risk scores, individual modifiable cardiovascular risk factors, quality of life, mental health, self- management capacity, process and economic outcomes.

Eligibility criteria:
inclusion criteria: * •hiv infected adults aged 30 years or over. * receiving ongoing primary hiv and general care at a study site and likely to remain in follow up at that site for 12 months. * willing and able to provide written informed consent. exclusion criteria: * •diagnosed cardiovascular disease, consisting of coronary heart disease, stroke or transient ischaemia attack, or peripheral arterial disease. * previous participation in a self-management or coaching program.

Keywords: hiv cardiovascular disease self-management hiv co-morbidities self-efficacy coronary heart disease risk quality of life
impact of muscle training device on non-severe osa

Conditions: OSA; Obstructive Sleep Apnea

Summary: the goal of this clinical trial is to test for the efficacy of the newly invented device #didgeritu with non-severe obstructive sleep apnea. the main question it aims to answer is: • can didgeritu reduce apnea events in patients with non-severe obstructive sleep apnea? researchers will compare didgeritu with a sham device to see how the apnea event has changed. participants will: * use didgeritu or sham device for 3 month * do an online questionnaire once a month during the study * home sleep test, lung function test, and tongue strength test at the start and end of the study

previously, in switzerland, an aboriginal musical instrument, the didgeridoo, was taught to patients with osa. it has been proven to be effective in reducing apnea events. our newly invented instrument, didgeritu, adopts the didgeridoo principle for expiratory muscle exercise to reduce apnea events.

Eligibility criteria:
inclusion criteria: * patients diagnosed with mild to moderate obstructive sleep apnea. * age 18 years or older. * patients voluntarily consent to provide information for research purposes. exclusion criteria: * patients with an average apnea-hypopnea index (ahi) of \ 29 events per hour after repeated diagnosis using a home sleep apnea test. * patients who refused to cease using cpap during the study process * patients with a history of chronic lung disease. * elderly patients with neurological conditions that impair cognitive function, such as dementia, stroke, or psychiatric disorders. * patients taking medications that may affect muscle function within 3 months before the start of the study. * patients with hypothyroidism or other conditions that may affect muscle function. * patients who consume alcohol at a moderate level or higher

Keywords: device emst powerbreathe didgeridoo didgeritu expiratory muscle exercise reverse cpap
phase ii dose-finding study of kwa-0711 in patients with chronic constipation (cc)

Conditions: Chronic Constipation

Summary: the purpose of this study is to evaluate the efficacy and safety of kwa-0711, and to determine its optimal dose in chronic constipation (cc) patients.


Eligibility criteria:
inclusion criteria: * the patients who experienced fewer than three sbms per week for more than 6 months prior to the enrollment. * the patients who experienced one or more of the following signs or symptoms during more than 25% of bowel movements for more than 6 months: straining, lumpy or hard stools, and a sensation of incomplete evacuation. exclusion criteria: * patients who have secondary constipation caused by systemic disorder. * patients who have organic constipation. * patients who received intestinal resection.

Keywords: chronic constipation cc
malignant genito-urinary tumors in children: south egypt cancer institute experience

Conditions: Genitourinary Neoplasms; Neoplasms, Genitourinary

Summary: the aim of this study is to identify demographic \& disease characteristics in pediatric oncology patients diagnosed with one of genitourinary tumors \& treatment outcomes in these patients.

background: tumors of the kidney, bladder, prostate, testis, and adrenal represent a large part of the adult urologic practice, but are relatively infrequent in children. genitourinary tumors contribute to pediatric solid tumors. wilms tumor, rhabdomyosarcoma, and germ cell tumors are the most common malignant genitourinary tumors in children. the natural history and management of these tumors in the pediatric age is different from that of the adults. as result of the successful work of several clinical trial groups in recent decades, there has been a significant improvement in their cure rates. patients \& methods: from january 2001 till december 2015, retrieval \& analysis of the medical records of pediatric patients with genitourinary tumors will be made at the pediatric oncology department, south egypt cancer institute which represents the largest referral center in upper egypt. these data will be categorized according to demographic characteristics, clinico-pathologic features, treatment modalities received, and outcomes of treatments in these patients.

Eligibility criteria:
inclusion criteria: * patients whose age less than or equal to 18 years. * patients diagnosed with any of neoplasms affecting the genitourinary system. exclusion criteria: * patients whose age more than 18 years.

Keywords: childhood cancer genitourinary tumors urogenital tumors pediatric oncology
adding male single dose hpv vaccination to female hpv vaccination in tanzania

Conditions: HPV Infection; Vaccine Preventable Disease

Summary: add-vacc is an unblinded cluster-randomised trial (crt) with two arms: (i) the national hpv vaccination programme (girls aged \~14 years, control arm) and (ii) the national programme plus single-dose male hpv vaccination given to a multi-year cohort of boys (intervention arm). the crt will be conducted in 26 communities/clusters (13 per arm) in northern tanzania. boys aged 14 to 18 years in the intervention arm will receive one dose of the 4-valent hpv vaccine (gardasil®) that protects against hpv 6, 11, 16, and 18. population genital hpv prevalence in 18 to 21-year-olds will be compared between intervention clusters (female and male vaccination) and control clusters (female vaccination only) at 3 years after the intervention. blood sampling for immune responses and adverse event data collection will be performed in a subset of 200 male subjects in selected intervention clusters.


Eligibility criteria:
inclusion criteria: * parents and adult male participants (aged 18 years) must sign an icf and male participants aged less than 18 years must sign an informed assent form (iaf), indicating that they understand the purpose of and procedures required for the study and are willing to participate in the study and to receive hpv vaccination. if the parent or participant cannot read or write, the procedures must be explained and informed consent/assent must be witnessed by a literate third party who is not involved in the conduct of the study. * participants must have been born male, and must be aged 14 to 18 years inclusive at time of vaccination. * participants must be living in an intervention community (cluster). * participants must be willing and able to comply with the protocol requirements. * participants must agree to avoid all non-trial immunisations in the 14 days following vaccination with the trial vaccine, other than emergency vaccinations such as post-exposure rabies or tetanus vaccinations. * participants must be healthy as determined by a medical history. a physical examination will be conducted if necessary according to the clinician's judgement. exclusion criteria: boys will be excluded from hpv vaccination if: * they have previously been vaccinated against hpv. * they have a history of allergy or anaphylaxis to one or more of the hpv vaccine components, to yeast or to latex. * they are enrolled in another vaccine research study that specifically specifies that they must not participate in a study of another vaccine * they have been diagnosed with a chronic condition (except hiv, as per the comment above), such as an autoimmune condition, sickle cell disease, degenerative disease, neurologic or genetic disease, among others; * there are significant conditions or clinically significant findings for which, in the opinion of the investigator, participation would not be in the best interest of the participant (e.g., it would compromise their safety or well-being).
impact of pve on patient's long-term survival, complications and cancer recurrence.

Conditions: Liver Cancer; Liver Metastases

Summary: for patients with colorectal liver metastasis (clm), the prospect of long-term survival relies on liver resection. wistfully, more than 75 % of patients with clm are initially unresectable, due to an insufficient future liver remnant (flr) volume in order to increase flr volume, most patients will first receive chemotherapy to reduce the tumor load (downsizing). when chemotherapy is insufficient to provide an adequate postoperative flr, portal vein embolization (pve) can be performed. about 50-70 % of patients undergoing pve obtain a sufficient liver hypertrophy to allow liver resection. while pve is recognised for its efficacy to induce liver hypertrophy, some studies expressed substantial concerns regarding the potential adverse effect of this intervention on pre-resection tumor progression, increased risk of cancer recurrence following resection and reduced overall survival following resection those studies suggested that the need to perform pve should be assessed thoroughly for each patient and that chemotherapy should be maintained during the whole hypertrophy process in order to contain the potential adverse effect of pve on tumor progression. other studies found no significant association between pve and negative oncological outcomes. as mentioned in almost every study cited above, more data is needed to provide a clearer vision regarding the impact of pve on tumor progression and cancer recurrence following liver resection. the aim of this study is to compare the overall and disease-free survival of pve-requiring patients to the ones who underwent upfront surgery (nopve). as a secondary objective, the impact of several covariates (related to surgery, patient's condition and disease stage) on survival and cancer recurrence will be tested. our hypothesis are that 1) pve might be associated with a lower overall survival and a higher risk of cancer recurrence in univariate analysis but 2) this association will not remain significant when other covariates are included in the proportional cox hazard models.


Eligibility criteria:
patients with the following inclusion criterias were approached: * diagnosis of colorectal liver metastasis (clm). * scheduled for a one-stage right/extended right hepatectomy in centre hospitalier universitaire de montréal (chus) - hospital saint-luc. exclusion criterias: * individuals requiring a two-stage hepatectomy. * patient who had previous hepatectomy.
safe and timely antithrombotic removal - ticagrelor (star-t)

Conditions: Hemorrhage, Surgical; Blood Loss, Surgical; Blood Loss, Postoperative; Hemorrhage Postoperative

Summary: prospective, multi-center, double-blind, randomized pivotal trial to evaluate the safety and effectiveness of the drugsorb-antithrombotic removal (atr) system for intraoperative removal of ticagrelor in patients undergoing urgent cardiothoracic (ct) surgery with cardiopulmonary bypass (cpb).

antithrombotic agents such as ticagrelor can increase the risk of surgical bleeding in patients undergoing ct surgery if there is not adequate washout time of the drug. patients who require urgent surgery may not be able to wait for the recommended washout time (up to 7 days). the intraoperative use of the drugsorb-atr device to remove active ticagrelor may help reduce the risk of postoperative surgical bleeding in these patients.

Eligibility criteria:
inclusion criteria: 1. male or female 18 years of age or older, with documented full, written informed consent 2. requiring cardiothoracic (ct) surgery with cardiopulmonary bypass (cpb) within two days of ticagrelor discontinuation (day of last dose = day 0) exclusion criteria: 1. ct surgery occurring 3 days or greater following ticagrelor discontinuation 2. heart-lung transplant procedures 3. procedures for implant or revision of left ventricular assist device (lvad) or right ventricular assist device (rvad) 4. pre-existing conditions that pose a known risk for bleeding (i.e., heparin induced thrombocytopenia /thrombosis \[hitt\], perioperative platelet count \ 1.5) 5. prohibited concomitant antithrombotic medications as defined in the study protocol 6. acute sickle cell crisis 7. known allergy to device components 8. active (untreated) systemic infection 9. history of major organ transplantation and those currently receiving immunosuppressive medication or who are profoundly immune suppressed 10. women with positive pregnancy test during current admission or who are breast-feeding 11. life expectancy \<30 days 12. inability to comply with requirements of the study protocol 13. treatment with investigational drug or device within 30 days of current surgery 14. previous enrollment in this trial
cognitive exercise therapy approach biopsychosocial questionnaire (bety-bq) in patient with temporomandibular disorders

Conditions: Temporomandibular Disorder; Temporomandibular Joint Disorders; Temporomandibular Joint Dysfunction Syndrome

Summary: the aim of this study is to investigate the validity, reliability, and responsiveness of the cognitive exercise therapy approach-biopsychosocial questionnaire (bety-bq) in individuals with temporomandibular disorder. the following are alternative hypotheses of the study: * bety-bq has significant convergence with the patient health questionnaire-9 measuring depression. * bety-bq has significant convergence with the patient health questionnaire-15 measuring physical symptoms. * bety-bq has significant convergence with the generalized anxiety disorder-7 measuring anxiety. * bety-bq has significant convergence with the short form-36 measuring quality of life. * bety-bq has significant convergence with the craniomandibular pain and disability inventory measuring disability. * bety-bq has significant convergence with the mandibular function impairment questionnaire measuring function. * bety-bq has significant stability. * bety-bq has significant internal consistency.

patient health questionnaire-9 (depression), patient health questionnaire-15 (physical symptoms), generalized anxiety disorder-7 (anxiety), short form-36 (quality of life), craniomandibular pain and disability inventory (disability), and mandibular function impairment questionnaire (function) will be administered to participants. for reliability analysis, test-retest stability evaluations will be repeated with the same questionnaire on 30 individuals with a 2-week interval. to determine responsiveness, the same questionnaire will be reapplied to the same 30 individuals at 3-month intervals.

Eligibility criteria:
inclusion criteria: * having received a diagnosis of temporomandibular disorder exclusion criteria: * experiencing difficulty in cooperating to fill out the questionnaires * being unwilling to participate in the study

Keywords: validity reliability responsiveness
efficacy of post-radiation adjuvant temozolomide chemotherapy in residue low-grade glioma

Conditions: Astrocytoma; Oligodendroglioma; Oligodendroastrocytoma

Summary: low-grade glioma (lgg) is a common primary brain tumor in young adults. the infiltrative nature and frequent growth in eloquent area in brain often makes total resection impossible. until now, no agreement has been achieved on the treatment of lgg without total resection. post-radiation adjuvant temozolomide (tmz) is currently the standard of care for high-grade gliomas. radiotherapy or tmz is recommended for the treatment of residue low-grade gliomas. however, the efficacy of combined radiotherapy with adjuvant tmz for residue lgg remains to be defined. in this randomized controlled trial, the investigators will test the hypothesis that radiotherapy with subsequent tmz chemotherapy is superior to improve the progression-free survival of patients with residue lgg without significant impairment to quality of life compared to radiotherapy alone.


Eligibility criteria:
inclusion criteria: * age: 18 years to 60 years * incompletely resected supratentorial who ii astrocytoma, oligodendroglioma or oligodendroastrocytoma * karnofsky performance score ≥ 60 * adequate bone marrow, liver and renal function * ability of subject to understand character and individual consequences of the clinical trial * written informed consent exclusion criteria: * refusal to participate the study * known hypersensitivity or contraindication to temozolomide * previous irradiation, prior radiosurgery or prior chemotherapy * pregnant or lactating females * malignant tumor other than brain tumor * contraindicated for mri examination * unable to comply with the follow-up studies of this trial

Keywords: low-grade glioma radiotherapy chemotherapy