Kornimate/medical-research-clean huggingface dataset:
effectiveness of technology for metabolic diseases combined sarcopenia

Conditions: Metabolic Disease

Summary: the lifestyle program intervention program focusing on healthy dietary habit and exercise effectively prevents metabolic syndrome, sarcopenia or frailty. thus, the purpose of this study was to assess the efficacy of intervention program on metabolic syndrome subjects in taiwan.

the study is a 2-parallel groups' randomized controlled trial. participants with metabolic syndrome (three or more risk factors - triglycerides (tg) \>150 mg/dl, systolic blood pressure (sbp) ≥130 mm hg, diastolic blood pressure (dbp) ≥85 mm hg, or fasting blood glucose≥100 mg/dl; high-density lipoprotein cholesterol\<50 mg/dl, or waist circumference ≥80 cm) are enrolled. the four community units are randomized to receive a lifestyle intervention (intervention arm) or an education leaflet (control arm). the parameters are obtained from physical examination and biochemical assessments by well-trained case manager at baseline and 4th months. all participants complete a structured questionnaire, including basic information, sof, physical performance, physical activity, and food-frequency.

Eligibility criteria:
inclusion criteria: * older adult with age ≥ 40 years * community-dwelling * no hearing and visual acuity difficulties exclusion criteria: * unconscious * cognitive impairment or dementia

Keywords: self-health management metabolic diseases sarcopenia frailty intervention
quality of life in patients treated with leadless pacemakers

Conditions: Leadless Micra Transcatheter Pacemaker; Quality of Life

Summary: the study aims to carry out a domestic multi-center, prospective, non-randomized, non-blinded post-approval study to assess health-related qol between micra tps and conventional pm implantation. meanwhile, pocket and leads related complications would also be evaluated between these two strategies.


Eligibility criteria:
inclusion criteria: * with an age arranged from 18 to 80 years old; * conforming to indication of a pacemaker implantation; * life expectancy\>1 year; * normal cardiac function with preserved lvef; * adequate self-care ability or self-help skills before pacemaker implantation; * mentally healthy so as to participate in the quality-of-life assessments; * willing to participate in study through consent and willing to undergo study specific required procedures with expectancy of geographically stable for follow up duration. exclusion criteria: * subject with indication for icd/ crt-p/crt-d; * subject with persistent symptomatic sinus bradycardia; * subject has an existing or prior pacemaker, icd or crt device implant; * subject has unstable angina pectoris or has an acute myocardial infarction (ami) in the 30 days prior to eligibility assessment; * subjects with a mechanical tricuspid valve, implanted vena cava filter, or left ventricular assist device (lvad); * subjects with a life expectancy of less than 12-months; * subjects with medical condition which precludes patient from participation in the opinion of the investigator, such as arthritis, lung disease or previous stroke, renal dysfunction, recent major surgery within six months, clinically overt congestive heart failure; * pregnant women or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth regulation method or abstinence; * psychological disorders unable to participate in the quality-of-life assessments.
alk21-018: effects of medisorb® naltrexone (vivitrol®) on alcohol craving in treatment-seeking, alcohol-dependent adults

Conditions: Alcohol Dependence

Summary: this was a study of the effects of vivitrol® on alcohol cue-induced craving and the associated brain activation patterns in alcohol-dependent adults who had recently completed alcohol detoxification and were seeking further treatment for their alcohol dependence. the study was powered to to detect whether vivitrol attenuates or blocks the bold signal increases in response to alcohol-related cues. in the double-blind portion, subjects received a single administration of study drug (vivitrol 380 mg or placebo). subjects who completed the double-blind portion could opt to continue to the open-label portion and receive 2 additional months of treatment with vivitrol 380 mg.

the double-blind phase consisted of 6 visits over a 5- to 6-week period and included 2 telephone contacts and 2 functional magnetic resonance imaging (fmri) scans. the optional open-label extension included 2 visits approximately 1 month apart. subjects who completed both phases participated in a total of 8 scheduled visits (including 2 fmri scans and 2 telephone contacts) over a period of up to 14 weeks. at screening, eligible, consenting subjects were given an actiwatch®-score device. they were instructed to record their alcohol craving using this device throughout the double-blind phase. the actiwatch was programmed to beep every 3 hours ±20 minutes, thereby signaling the subjects to enter their craving or desire to use alcohol, at that exact moment, on a scale of 0 to 10 (with 0 being no craving at all and 10 being extreme craving). in addition, subjects entered any drug and/or alcohol use at the time of occurrence. the actiwatch was not utilized in the open-label portion of the study.

Eligibility criteria:
primary inclusion criteria: * current diagnosis of alcohol dependence, meeting at least 3 criteria from the diagnostic and statistical manual of mental disorders, 4th ed. (dsm-iv) * recently completed alcohol detoxification and seeking treatment for alcohol dependence * women of childbearing potential must agree to use an approved method of contraception for study duration primary exclusion criteria: * pregnancy or lactation * evidence of hepatic failure including: ascites, bilirubin \>10% above upper limit of normal (uln) and/or esophageal variceal disease * current dependence (within the past year) to benzodiazepines or cocaine, or current or history of opioid dependence according to dsm-iv criteria * use of any opioids and/or methadone within 14 days prior to the screening visit, or likely to require opioid therapy during the study period * previous enrollment in a vivitrol clinical trial or previous vivitrol experience * known intolerance and/or hypersensitivity to naltrexone, carboxymethylcellulose, or polylactide-co-glycolide (plg) * parole, probation, or pending legal proceedings having the potential for incarceration during the study period

Keywords: alcoholism addiction alcohol detoxification
precision assessment of platelet rich plasma for joint preservation

Conditions: Osteoarthritis

Summary: knee osteoarthritis (oa) is a leading cause of premature disability in veterans who develop knee oa at higher rates and younger ages than the population in general. for those with symptomatic early knee oa, who are years to decades away from meeting clinical indications for knee replacement surgery, knee injections have been a key treatment option. in recent years, platelet rich plasma (prp) injections have gained increasing attention for improving pain and function in patients with knee oa. basic science studies also suggest that prp may also potentially stimulate repair responses to articular cartilage. however, the mechanisms of action of prp in the treatment of knee oa are unknown. because autologous blood is used, the prp composition differs between patients. it is also unknown whether these differences in prp composition affect clinical outcomes. this study will address these gaps and provide critical new and objective information on prp treatment effects in veterans and additional women with early knee oa important to improving clinical use of this new treatment.

because very little is known about either the mechanisms of action or objective clinical outcomes of prp treatment for knee oa, the investigators propose a prospective "pre-post" study that will permit us to identify areas where more rigorous clinical outcomes and mechanistic research may be warranted. the proposed work includes special elements of: (1) quantitative metrics to assess clinical outcomes, (2) correlation of candidate beneficial proteins with clinical outcomes, and (3) proteomic evaluation of the injected prp. this work will use an innovative multi-disciplinary, personalized approach to evaluate the effects of prp composition on both function, as assessed by patient-reported outcomes and gait analysis, and cartilage matrix structure as assessed by quantitative mri

Eligibility criteria:
inclusion criteria: * symptomatic early knee oa * full weight-bearing status * have elected to receive prp treatment * male veterans * female veterans exclusion criteria: * inflammatory arthritis, gout or recurrent pseudogout * symptomatic oa of other lower extremity joints * bmi \>35 kg/m2 * use of walking, orthopedic, or prosthetic assistive device * severe systemic disease defined as american society of anesthesiologists (asa) 3 or above56 * inability to have mri * pregnant or intending to become pregnant during the study * predominantly patellofemoral disease

Keywords: prp osteoarthritis mri gait patient reported outcome
a study to explore the role of gut flora in covid-19 infection

Conditions: Gut Microbiome; Gastrointestinal Microbiome; COVID; COVID-19; Corona Virus Infection; Coronavirus; Coronaviridae Infections; Coronavirus 19; Coronavirus-19; COVID 19

Summary: this study seeks to determine whether the virus which causes covid-19, sars-cov-2, is shed in the stools of patients who are infected.

in this study the stool of patients who are being treated for covid-19 will be tested during treatment and then again following treatment to determine if the virus is shed in the stool during infection, afterwards, or both.

Eligibility criteria:
inclusion criteria: 1. signed informed consent, demonstrating that the patient understands the procedures required for the study and the purpose of the study 2. male or female of 18 years of age or older 3. diagnosis of covid-19 infection by rt- pcr within 1 week of screening exclusion criteria: 1. refusal to sign informed consent form 2. history of bariatric surgery, total colectomy with ileorectal anastomosis or proctocolectomy. 3. postoperative stoma, ostomy, or ileoanal pouch 4. treatment with total parenteral nutrition

Keywords: microbiome coronavirus corona virus 19 covid covid-19
strategies to improve bone health in men on adt

Conditions: Prostate Cancer

Summary: this is a phase ii randomized controlled trial (rct) of 2 strategies to improve bone health in men receiving androgen deprivation therapy (adt).

in this rct the investigators are comparing 2 strategies to improve bone health to usual care. strategy 1 - patient and physician-specific written educational material. pilot-tested customized written educational material about bone health for men on adt will be used for this study. a customized letter will be prepared for the patient's primary care physician, with specific advice and recommendations for the targeted strategies. both pamphlet and letter will include a list of additional resources. strategy 2 - patient written material and a bone health care coordinator (bhcc). the same written patient material as in strategy 1 will be used, along with a bhcc who will follow the approach of successful studies and contact the patient by phone or arrange an in-person visit at the hospital if preferred by the patient. the bhcc will also encourage the patient to pursue a bone mineral density test (bmd) with their physician and adopt bone-appropriate diet, lifestyle, and supplement intake recommendations, and will follow up with the patient at least twice over the next 3 months to facilitate behavioural changes and bmd ordering. counselling sessions are short, typically \<15 min. the bhcc will also contact the patient's physician to help facilitate bmd testing. time points in the study are baseline, 3-month follow up, and 6-month follow up. control group the control group consists of a wait-list control for 6 months, during which no specific recommendations or interventions will be made by the study team. prostate cancer (pc) clinicians can still provide usual care. at the end of 6 months, control group participants will be referred to the osteoporosis clinic at the university health network.

Eligibility criteria:
inclusion criteria: commencing or planning to continue adt for a least 6 months 50 years or older english fluency life expectancy \>6 months exclusion criteria: prior bone mineral density test within 2 years prior visit at osteoporosis clinic within 2 years

Keywords: prostate cancer androgen deprivation therapy bone health bone mineral density
feasibility and effectiveness of rehabilitation nursing for acute stroke

Conditions: Acute Ischemic Stroke; Nursing

Summary: in the clinical setting, it is difficult to obtain effective rehabilitation during the acute phase, the reasons may include insufficient awareness of early rehabilitation due mainly to a limitation in number and variety of rehabilitation professionals in low- and middle-income countries. it is necessary to shift tasks to other healthcare providers who are trained to provide rehabilitation like nurses. the purpose of this study is to examine the feasibility and effectiveness of a modified barthel index based rehabilitation nursing program on acute stroke inpatients.

ischemic stroke is the main cause of disability in the world. more than 70% of stroke patients show various degrees of neural function impairment. early rehabilitation in acute phase is beneficial for improving patient's activity of daily livings and motor function. however, it is difficult to obtain effective rehabilitation during the acute phase of stroke because of the insufficiency of professional rehabilitation therapists in stroke wards in china. the investigators assume that implementing program based on modified barthel index can realize nursing-directed motor rehabilitation during acute phase of ischemic stroke. the present study is to conduct quasi-experimental research to confirm the feasibility and effectiveness of nursing-directed precision rehabilitation in acute stroke patients.

Eligibility criteria:
inclusion criteria: * diagnosed with ischemic stroke and met the diagnostic criteria of the world health organization; * initial stroke within seven days, with limb dysfunction; * nihss scale consciousness scores of 0 or 1; * provided informed consent form. exclusion criteria: * incomplete clinical data; * having a physical disability or other diseases that affect the limb function; * having cognitive impairment or other diseases that interfere with participation; * having serious cardiopulmonary dysfunction or another disease that requires absolute bed rest; * having progressive stroke or having severe complications that patients drop the study before completion.
impact of perioperative nutritional status and management in the context of resectable pancreatic adenocarcinoma

Conditions: Pancreatic Adenocarcinoma

Summary: patients with pancreatic adenocarcinoma are frequently in a situation of malnutrition, in a context of functional alteration of the digestive tract, and hypercatabolism. as a result, nutritional support is frequently necessary perioperatively, but currently does not follow a specific protocol, and without coordination. it then appears the need to evaluate the prevalence of malnutrition, its impact on perioperative morbidity and mortality, and current management methods. depending on the findings, subsequent interventional studies will be carried out on the subject, exploring the different modalities of artificial nutrition.


Eligibility criteria:
inclusion criteria: * major subject (≥18 years old) * subject with pancreatic adenocarcinoma authenticated by pathology * subject candidate for curative surgical treatment * subject operated on in the visceral and digestive surgery department, nhc strasbourg, during the period from january 1, 2018 to december 31, 2022 * absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes. exclusion criteria: * subject having expressed opposition to participating in the study * subject presenting a metastatic form or one not accessible to surgical treatment considered curative of pancreatic adenocarcinoma * subject under guardianship or curatorship * subje

Keywords: pancreatic adenocarcinoma digestive tract hypercatabolism malnutrition,
reproductive and obstetric outcomes in tese-icsi cycles for azoospermia

Conditions: Obstructive Azoospermia; Non-obstructive Azoospermia; Obstetric Complication

Summary: a comparison of reproductive and obstetrical outcomes is retrospectively performed among couples that underwent icsi-tese cycles for obstructive and non obstructive azoospermia between january 2001 and december 2019.

azoospermia affects almost 20% of all infertile males and it can be divided into obstructive azoospermia (oa) and nonobstructive azoospermia (noa). assisted fertilization with testicular sperm extraction (tese) and intracytoplasmatic sperm injection (icsi) has been successfully applied for its treatment. review of the literature shows that there is a lack of consensus about reproductive outcomes between men with oa and noa. no study has ever investigated differences in obstetrical outcomes between these two groups before. the objective of this study is to retrospectively determine differences in reproductive and obstetrical outcomes among couples that underwent icsi-tese cycles for obstructive and non obstructive azoospermia. the primary outcomes that will be investigated include: * reproductive outcomes: pregnancy rate, live birth rate (lbr) and abortion rate. * obstetrical outcomes: twinning rate, gestational age, prematurity rate, birth weight, cesarean section rate and the rate of the main obstetrical complication, such as pre-eclampsia, gestational hypertension, intrauterine growth restriction (iugr).

Eligibility criteria:
inclusion criteria for obstructive azoospermia group: * infertility * diagnosis of obstructive azoospermia * icsi-tese cycles inclusion criteria for non-obstructive azoospermia group: * infertility * diagnosis of non-obstructive azoospermia * icsi-tese cycles exclusion criteria: * sperm donation * use of ejaculated sperm * couples who underwent pre-implantation genetic testing

Keywords: reproductive outcomes
olfactory disfunction and co-ultrapealut

Conditions: Anosmia; Covid19; Hyposmia; Parosmia; Treatment Compliance

Summary: olfactory dysfunction is common among patients with corona-virus-infection-disease (covid)-19, and up to 30% of patients may report persistent disorders of smell or taste as a long-term sequelae. this randomized-controlled study has addressed to compare the efficacy of neuro-protective and anti-inflammatory agents palmitoylethanolamide (pea) and luteolin(treatment) with control (olfactory training) in a cohort of patients who present persistent smell disorders after resolution from covid-19 and negative swab for 4 months at least.

patients ages 18 to 70 years with confirmed history of covid-19 (positive nasopharyngeal swab for sars-cov-2) and subjective olfactory dysfunction persisting ≥ 90 days after follow-up negative covid-19 nasopharyngeal swab are eligible. all patients will undergo nasal endoscopic examination to look for presence of polyps, masses, anatomic blockage, or other pathology which presence will require exclusion from the study. patients then will be evaluated at the baseline with sniffin' sticks (burghardt®, wedel, germany) prior to initiating olfactory training and/or supplement treatment (t0). one group received daily olfactory training, patients in the supplement group additionally received a daily oral tablet that contained pea 700 mg and luteolin 70 mg (glialia ®, epitech pharmaceutical, milano, italy), or 1 dose of pea-lut only or atwo dose of pea-lut. assessment of olfactory function will be repeated at 30 days, 60 and 90 and 120 days

Eligibility criteria:
inclusion criteria: * 18 to 90 years with confirmed history of covid-19 (positive nasopharyngeal swab for sars-cov-2) * subjective olfactory dysfunction persisting ≥ 90 days after follow-up negative covid-19 nasopharyngeal swab exclusion criteria: * previous history of olfactory-gustatory disorders * impaired cognitive function * history of neurodegenerative disease * medical therapy with possible effects on olfactory function * presence of rhinological disorders (sinusitis, rhinosinusitis, sinonasal polyposis, atrophic rhinitis, allergy) * history of chemo-radiotherapy of the head and neck region * history of stroke or neurotrauma * severe nasal blockage from stenosis of deformity * severe psychiatric illness (e.g. schizophrenia, bipolar disorder, olfactory hallucination) * previous sinonasal * nasopharyngeal tumors.
yttrium-90 radioembolization using glass microspheres (therasphere) for patients with liver metastases

Conditions: Colorectal Neoplasms; Neuroendocrine Tumors; Cholangiocarcinoma; Melanoma; Breast Cancer

Summary: this is a prospective pilot study designed to document safety and efficacy of liver-directed therapy for colorectal, neuroendocrine, cholangiocarcinoma, melanoma, and breast cancer metastases to the liver using yttrium-90 glass microspheres (therasphere).


Eligibility criteria:
inclusion criteria: * diagnosis of metastatic colorectal, neuroendocrine, cholangiocarcinoma, melanoma, or breast malignancy with liver dominant disease. diagnosis may be made by histo- or cyto-pathology, or by clinical and imaging criteria. * the cancer is unresectable. * all patients must be off all chemotherapeutic regimens for 30 days prior to and 30 days after therasphere treatment. concurrent therapy with octreotide is permitted, when appropriate. * eastern cooperative oncology group (ecog) performance status of 0-2. * age 18 years or older. * able to understand informed consent. exclusion criteria: * evidence of potential delivery of greater than 16.5 mci (30 gy absorbed dose) of radiation to the lungs on either: * single therasphere administration; or * cumulative delivery of radiation to the lungs greater than 50 gy over multiple treatments. * evidence of any detectable tc-99m macroaggregated albumin deposition in the stomach or duodenum, after application of established angiographic techniques to stop such deposition. * previous radiation therapy to the lungs and/or to the upper abdomen * pregnancy * symptomatic lung disease. * significant extrahepatic disease representing an imminent life-threatening outcome. * active uncontrolled infection * any pre-treatment laboratory findings within 30 days of treatment demonstrating: * aspartate or alanine aminotransferase level greater than 5 times upper normal limit. * serum bilirubin greater than 2 mg/dl * infiltrative tumor on imaging * tumor volume greater than 70% of liver volume * tumor volume greater than 50% of liver volume and serum albumin level less than 3 mg/dl

Keywords: liver metastases