Kornimate/medical-research-clean huggingface dataset:
lymphedema following hand/wrist surgery in women post axillary node dissection

Conditions: Lymphedema

Summary: this is a prospective, randomized, equivalence trial designed to evaluate postoperative complications following hand surgery with a brachial tourniquet and without a tourniquet in patients that have previously had a mastectomy with axillary node dissection with or without radiation treatment or history of lymphedema.


Eligibility criteria:
inclusion criteria: * patients with a history of ipsilateral mastectomy with lymph node dissection with or without radiation treatment. * patients ages 18 and over * patients who have failed conservative, nonoperative treatment and present for an elective hand procedure with an anticipated tourniquet time of \< 20 minutes. * the subject is psychosocially, mentally, and physically able to understand and comply with the requirements of the study. exclusion criteria: * patients that are not postoperative mastectomy with lymph node dissection with or without radiation treatment * patients under the age of 18 * patients who are pregnant * patients presenting for an elective hand procedure with an anticipated tourniquet time of \> 20 minutes. * patients who are on a blood thinner which cannot be stopped prior to surgery * the subject has another concurrent physical or mental condition that is likely to affect compliance with the study requirements.
latent tuberculosis in second generation immigrants from high risk countries compare to low-risk young israeli adults

Conditions: Latent Tuberculosis

Summary: the aim of study is to evaluate the prevalence of latent tb in second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000) compare to the control native israelis without a family member who was born in a country with high incidence of tuberculosis. using study questionnaire igra and tuberculin skin test the investigators expect that the second generation immigrants group will have more positive igra test than the control native group.


Eligibility criteria:
inclusion criteria: * age 18-25 * men and women * second generation immigrants from countries with high incidence of tuberculosis (above 20 of 100,000). * native israelis without a family member who was born in a country with high incidence of tuberculosis. exclusion criteria: * prior contact with a tuberculosis patient * working (more than a month) in high risk setting such as health care workers, working with immigrants from countries with high incidence of tuberculosis. * hiv infection and any immunodeficiency condition. * recent live-virus vaccination * acute infectious disease * prior serious reaction to tuberculin skin test * pregnancy

Keywords: latent tuberculosis tuberculin skin test interferon gamma release assay immigration
does a non-opioid multimodal pain (nomo) protocol decrease narcotic use

Conditions: Opioid Use

Summary: the objective of this study is to evaluate narcotic use after implementation of a non-opioid multimodal pain (nomo) protocol in patients who are undergoing a urogynecologic procedure. the study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). study participants will be asked to utilize the validated brief pain inventory (appendix a) scale to assess post-operative pain levels. based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.

the objective of this study is to evaluate narcotic use after implementation of a non-opioid multimodal pain (nomo) protocol in patients who are undergoing a urogynecologic procedure. nomo protocols seek to reduce the opioid usage for patients in the postoperative period. patients will receive multiple pain medications (usually referred to as a "pain cocktail") that work on various pain receptors throughout the body. these medications are approved for pain control; but they have few side effects and less addictive properties. the study will also evaluate secondary outcomes, including: post-operative pain rating, length of hospital stay, postoperative antiemetic use, bladder catheterization at discharge, number of post-operative phone calls, and rate of reported side effects of opioid use (nausea/constipation). study participants will be asked to utilize the validated brief pain inventory (appendix a) scale to assess post-operative pain levels. based on inpatient post-operative opioid use and number of opioid pills prescribed at discharge, an attempt will be made to develop an algorithm for recommended opioid prescribing patterns.

Eligibility criteria:
inclusion criteria: * english-speaking females * greater than or equal to 18 years old * scheduled for a urogynecologic procedure at ghs requiring inpatient stay or extended observation. exclusion criteria: * less than 18 years of age * non-english speaking patients * unscheduled urogynecologic surgeries * patients expected to undergo a simple reconstructive surgery with same-day discharge, * history of chronic pain * chronic lyrica or celebrex use * psychiatric disorder, narcotic dependence or narcotic prescription in the past six weeks * current liver disease * kidney disease (defined as gfr \<60) * malignancy * sulfa allergy
dementia antipsychotics and antidepressants discontinuation study

Conditions: Dementia

Summary: the aim of this study is to discontinue antipsychotics and antidepressants, and to study its effect on behavioural- and psychological symptoms in dementia (bpsd).

patients with dementia have cognitive deficits, but also hallucinations, delusions, agitation, aggression and apathy. these symptoms are called behavioural- and psychological symptoms in dementia (bpsd), and are difficult to treat. antipsychotic and antidepressant medication is used as treatment, despite its lack of clinical evidence. we will discontinue risperidone in one group of 30 patients and compere them to 30 controls and we will discontinue antidepressants in a group of 76 patients and compere them to 76 controls. patients should have dementia of alzheimer- or vascular origin. they should live in nursing homes and have no other psychiatric disease for which they receive psychotropic drug. they will be registered with 7 different questionnaires at baseline and after 3, 6, 12 and 24 weeks. the study period is 24 weeks. the questionnaires are filled in by the patients and the nurses at the nursing homes. this is a double blind rct study with placebo-controlled group.

Eligibility criteria:
inclusion criteria: * vascular- or alzheimer dementia * nursing homes resident for 3 months or more * given antipsychotics or antidepressants for 3 months or more * clinical dementia rating 1, 2 or 3 exclusion criteria: * dementia of other origin * psychiatric disease * life expectancy less than 3 months * acute infection last 10 days * unstable diabetes mellitus * terminal disease

Keywords: antidepressants antipsychotics dementia discontinuation study behavioural- and psychological symptoms in dementia
evaluation of fosmidomycin and clindamycin in the treatment of acute uncomplicated plasmodium falciparum malaria

Conditions: Malaria

Summary: few efficient drugs for malaria treatment are available so far. due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of plasmodium falciparum, new drug combinations have to be actively investigated. the investigators will test the efficiency, safety and tolerance of combined fosmidomycin and clindamycin treatment in acute uncomplicated malaria in children aged 3-10 years.

few efficient drugs for malaria treatment are available so far. due to increased exposure of these drugs and due to the high risk of development of drug resistant strains of plasmodium falciparum, new drug combinations have to be actively investigated. the goal of this study is to assess a new drug combination, fosmidomycin-clindamycin. the primary objective of the study is to assess and compare the efficacy, safety and tolerance (between sites) of fosmidomycin and clindamycin when co-administered orally over three days in the treatment of acute uncomplicated plasmodium falciparum malaria in children in mozambique and gabon. the secondary objective is to differentiate between recrudescent parasitaemia and reinfection in the event of recurrent parasitaemia developing within the 28-day follow-up period, to determine the population pharmacokinetics of fosmidomycin when co-administered orally with clindamycin and to compare the in vitro sensitivity of isolates of plasmodium falciparum to fosmidomycin. the trial will include 100 children aged 3-10 years, divided between clinical sites of gabon and mozambique.

Eligibility criteria:
inclusion criteria: * male or female subjects aged three to ten years * body weight ≥12kg * acute (symptoms lasting less than 14 days) uncomplicated p falciparum malaria * asexual parasitaemia between 1,000/µl and 200,000/µl * ability to tolerate oral therapy * willingness of the parent or guardian to provide informed signed consent exclusion criteria: * symptoms/signs of severe malaria, according to who criteria (see appendix i) * body weight \<12kg * other concomitant plasmodial infections (p vivax, p ovale, p malariae) * severe malnutrition with weight for height \<70% (according to who tables) or clinical kwashiorkor * gastro-intestinal disturbance with persistent vomiting (\> three episodes within previous 24 hours) and/or diarrhoea (\> 5 loose stools in the preceding 24 hours) * concomitant disease masking assessment of response including sickle cell disease and severe cardiac, hepatic or renal impairment * packed cell volume (pcv) on arrival \<22% * adequate anti-malarial treatment within previous 7 days * inability to tolerate oral therapy * parent or guardian deemed to be unsupportive * on co-trimoxazole prophylaxis * any known allergies to the investigational products
diagnostic performance evaluation of a novel sars-cov-2 (covid-19) antigen detection test

Conditions: Covid19; SARS-CoV-2 Infection

Summary: the current prospective study was designed to assess the diagnostic specificity and sensitivity of a novel antigen-based rapid detection test (covid-viro®) on nasopharyngeal specimens in comparison to the reference test in a real-life setting

two nasopharyngeal swab specimens will be concurrently collected on: * adult patients hospitalized in the infectious diseases department of the centre hospitalier régional d'orléans (chro) for confirmed sars-cov-2 infection, * or symptomatic or asymptomatic subjects voluntarily accessing the covid-19 screening department of the chro to perform a diagnostic test. covid viro® diagnostic. specificity and sensitivity are assessed in comparison to real-time rt-qpcr results.

Eligibility criteria:
inclusion criteria: * adult patients (\>18 years old) already having a sars-cov-2 rt-qpcr positive result within 5 days * adult patients (\>18 years old) requiring a sars-cov-2 rt-qpcr on nasopharyngeal swab specimen for any reason exclusion criteria: * patients non wishing to participate * under guardianship or curatorship or safeguard of justice patients * inability to join the hospital other than by public transport

Keywords: sars-cov-2 infection covid19 antigen detection test
psychometric properties of the turkish version of young children's participation and environment measure

Conditions: Child Development Disorder; Activity, Motor

Summary: the young children's participation and environment measure (yc-pem) is a parent/caregiver reported outcome measure that evaluates the participation status and environmental factors of children under five years old. the aim of this study is to translate the young children's participation and environment measure (yc-pem) into the turkish language and to investigate the psychometric properties of the turkish version of yc-pem in children with typical development and neurodevelopmental disabilities under five years old.

cross-cultural adaptation rest-retest reliability discriminant validity concurrent validity

Eligibility criteria:
inclusion criteria: * children under five years * children with neurodevelopmental disabilities exclusion criteria: * parents who refused to participate in the study

Keywords: cerebral palsy activity participaiton environment
walking aid and locomotion knowledge in emergency rooms (walker 1) for elderly people

Conditions: Mobility Limitation

Summary: older adults have higher rates of emergency department admissions when compared to their younger counterparts. mobility is the ability to move around but also encompasses the environment and the ability to adapt to it. walking aids can be used to improve mobility and prevent falls. according to international guidelines, they must be available in geriatric emergency department. this study aims to evaluate the effectiveness of a program of training and provision of walking aids (wa), associated or not with telemonitoring, on mobility, quality of life, fear of falling, and risk of falls up to 3 months in older adults cared for in an emergency department.

a randomized clinical trial will be carried out in the emergency department of hospital sírio-libanês. participants will be randomized and allocated into three intervention groups, as follows: a) walking aid group; b) walking aid and telemonitoring group; c) control group. patients will undergo a baseline evaluation encompassing sociodemographic and clinical data, mobility in life spaces (life space assessment), gait speed, muscle strength, functionality (barthel index, katz index, and lawton-brody scale), quality of life (euro quality of life instrument-5d), fear of falling (falls efficacy scale international), history of falls, cognition (10-point cognitive screener) and mood (15-point geriatric depression scale) before the intervention. gait time and fear of falling will be assessed again after the intervention. finally, mobility in life spaces, functionality, quality of life, fear of falling, history of falls, cognition, and mood will be assessed 3 months after discharge from the geriatric emergency department through a telephone interview.

Eligibility criteria:
inclusion criteria: * 65 years or older * admitted to the geriatric emergency department of hospital sírio-libanês * willing and able to give informed consent * least one of the following for indication and training of mobility aids: reduction of postural instability; improvement of motor control; increase of somatosensory feedback; reduction of biomechanical overload; safe promotion of autonomy; fall history (in the last six months). exclusion criteria: * altered level of conscience * need for supplemental oxygen (≥3l/min) * respiratory distress * hemodynamic instability * postural instability with a tendency to fall backward * cognitive impairment that limits the use of walking aids * hospitalization after emergency department evaluation * delirium

Keywords: geriatric life space walking aids emergency room clinical trial mobility
effect of laparoscopic cholecystectomy on risk of metabolic syndrome

Conditions: Cholelithiasis; Metabolic Syndrome

Summary: prospective cohort study. population: patients with gallstone disease qualified for laparoscopic cholecystectomy intervention: patients undergoing cholecystectomy for gallstones comparison: gallstone disease without surgery in an observation period outcome: metabolic syndrome symptoms evaluated in 3 months period the main inclusion criteria is cholelithiasis confirmed by ultrasound examination in patients between 18-75 years old. the main exclusion criteria are metabolic syndrome, diabetes, thyroid diseases, pancreatic diseases, serious abdominal surgeries in the past, pregnancy, and lactation. participants who qualified for laparoscopic cholecystectomy in 3 months are included in the investigation group. those not having cholecystectomy planned in the upcoming three months for any reason (no consent for surgery, long term) are included in the control group. the intervention is to assess all metabolic syndrome criteria (blood pressure, glucose tolerance, dyslipidemia, abdominal obesity) before and three months after surgery. the endpoint is to evaluate if the risk of metabolic syndrome after cholecystectomy is higher than in patients with gallstones.

laparoscopic cholecystectomy is well known as a gold standard of treatment for gallstone disease. gallbladder removal is one of the most common procedures in the united states, with more than 1.2 million cholecystectomies per year, and 92% of the procedures are performed laparoscopically. in 2011 amigo et al. reported increased triglyceride levels in mice after cholecystectomy. according to ruhl et al. (2013), cholecystectomy is associated with an increased risk of non-alcoholic fatty liver disease that is considered a liver manifestation of metabolic syndrome. in 2014, shen et al. published a retrospective study enrolling 5672 participants that demonstrated an increased risk of metabolic syndrome after cholecystectomy compared with gallstone disease alone. metabolic syndrome (ms) is a disease of civilization. it is a group of disorders containing impaired glucose intolerance, hypertension, abdominal obesity, and dyslipidemia. according to meta-analysis, individuals reaching the criteria of metabolic syndrome have a twice higher risk of myocardial infarction or stroke and a 1,5-times higher risk of death for any reason. the study aims to assess the risk of metabolic syndrome after laparoscopic cholecystectomy prospectively.

Eligibility criteria:
inclusion criteria: * cholelithiasis exclusion criteria: * metabolic syndrome * obesity * diabetes * thyroid disease * pancreatic disease * serious abdominal surgeries in the past * pregnancy, lactation
evaluating community health centers' adoption of a new global capitation payment

Conditions: Chronic Diseases

Summary: the investigators are conducting a prospective analysis of the alternative payment methodology (apm) demonstration project sites. the investigators' goal is to conduct a cross project analysis of findings. the investigators propose to use mixed methods to study processes and outcomes associated with the apm natural experiment in payment reform. the investigators hypothesize that community health centers (chcs) participating in the apm demonstration project will redesign their workflows to better focus on patient and population health needs, resulting in reallocation of financial resources, lower overall costs, changes in utilization patterns, and improved quality.

led by the oregon primary care association, three community health center (chc) organizations in oregon developed an alternative payment methodology (apm). under this apm pilot participating chcs will receive a prospective payment system (pps) payment as a capitated equivalent in a per-member-per-month rate for all of their medicaid patients. oregon chc organizations (several clinic sites) implemented phase i of this demonstration project on march 1, 2013; phase ii a was implemented on july 1, 2014; phase ii b on october 1, 2014; and phase iii began july 1, 2015. we are a prospective analysis of the apm project sites. we propose to use mixed methods to study processes and outcomes associated with the apm natural experiment in payment reform. we hypothesize that chcs participating in the apm demonstration project will redesign their workflows to better focus on patient and population health needs, resulting in reallocation of financial resources, lower overall costs, changes in utilization patterns, and improved quality. the study will include baseline qualitative data collection as clinics are transitioning to the apm methodology. we will conduct 2 site visits to each intervention clinic to observe practice changes that occurred post apm-implementation (first visit approximately 12-18 months post-apm implementation; second visit approximately 30-36 months post-apm implementation). we will also assemble and analyze of pre-post quantitative and qualitative datasets, and interpretation and dissemination of study findings.

Eligibility criteria:
inclusion criteria: 1. total clinic population: established patients at intervention and control clinics aged 2-64 2. medicaid population: medicaid-enrolled patients at intervention and control clinics aged 2-64 exclusion criteria: 1. total clinic population: non-established patients at intervention and control clinics aged 2-64 2. medicaid population: non-medicaid-enrolled patients at intervention and control clinics aged 2-64

Keywords: health expenditures prospective payment system health care utilization health care quality, access, and evaluation
anti-covid-19 vaccine side effects

Conditions: Vaccine Adverse Reaction; Gender; COVID-19 Vaccine Adverse Reaction

Summary: in 2021 and following the covid-19 (corona virus disease 2019) pandemic, different vaccines were initially authorized in italy and lebanon. notably, vaccine side effects were poorly recorded. thus, the investigator performed a survey study to monitor covid-19 vaccine side effects among italian and lebanese citizens according to gender and age through a web-based questionnaire in italian and arabic languages including 21 items by "google form", investigating 13 symptoms, and employing social-media platforms

the covid-19 pandemic has presented a real challenge to the public health system worldwide since the year 2019, spreading to more than 200 countries and regions worldwide.the emergence and rapid spread of covid-19 were caused by the coronavirus sars-cov-2. worldwide, the use of covid-19 vaccines was initially authorized for emergency use and the side effects were not stated clearly. common side effects were expected but specific side effects linked with covid-19 vaccines remained uncertain. in this context, survey studies are needed for a comprehensive evaluation of the relationships between vaccine administration, related undesired effects and vaccine safety. this study represents the first survey following early covid-19 vaccines administration in two geographic areas, comparatively considering possible differences due to gender and age. a web-based survey was conducted on a cohort of 1975 italian and 822 lebanese people who received at least one dose of covid-19 vaccine. the study was conducted between march and july 2021 on a voluntary basis, and by a tailored anonymous web-based questionnaire. the protocol was approved by the local ethics committee, university of bari 'aldo moro' (study number 6752, protocol number 0031044). a specific questionnaire was designed in english and translated into italian and arabic. it contains 21 items including demographic data, the history of vaccine administration before covid-19, the administration of the first and second dose of covid-19 vaccine, and possible adverse effects. the survey link was shared by a "google form" employing social-media platforms or by personal interview. the questionnaire explored the presence of 13 possible symptoms appearing following the administration of the first and second dose of covid-19 vaccine: pain at the injection site, redness at the injection site, swelling at the injection site, induration at the injection site, allergic-urticarial reaction, anaphylaxis, fever (\>37 °c), diarrhea, vomiting, asthenia/fatigue, muscle pain, rash, sleepiness/insomnia, irritability/nervousness, headache, lymphadenopathy. the presence and intensity of symptoms were assessed semi-quantitatively by a visual analogue scale (vas). besides symptoms, the following aspects were also evaluated: need of drug intake, consultation of a doctor, emergency admission to hospital, and possible hospitalization.

Eligibility criteria:
inclusion criteria: * anti-covid-19 vaccine exclusion criteria: * subjects who living outside italy or lebanon