Kornimate/medical-research-clean huggingface dataset:
clinical trial to study quality of life in prostate cancer patients by randomizing anti-androgen versus total androgen blockage prior to curative intended radiation therapy

Conditions: Prostate Cancer

Summary: phase iii clinical trial to study quality of life in prostate cancer patients by randomizing anti-androgen versus total androgen blockage prior to curative intended radiation therapy.

primary objective: to study the difference in quality of life in relation to anti-androgen versus total androgen blockage. exploratory parameters: ▪ time to psa relapse * time to symptom giving metastasis * overall survival patients with localized /locally advanced prostate cancer were subject to treatment with curative intention. they could be divided into three groups according to the risk of metastasis. mainly intermediate risk group of patients were included in this study. patients with low risk could be included if they were subject to neo-adjuvant hormonal therapy. different risk groups were defined as below: low risk group: psa ≤10 ng/ml gleason score ≤ 6 tumour stage ≤ t2b intermediate risk group: presence of 1-2 factors of high risk. high risk group: psa \>10 ng/ml gleason score ≥7 tumour stage t2c - t3b

Eligibility criteria:
1. histopathologically verified prostatic adenocarcinoma. 2. all consecutive patients referred for radiation therapy with combination method i.e. both external beam rt and hdr brachytherapy or other fractionation with curative intention. 3. patients with intermediate risk group of prostate cancer will mainly be included in this study where radiotherapy with intention to cure is indicated and possible to perform. the intermediate risk group is defined as having 1-2 high risk factors for metastasis. patients with low risk can only be possible to include if there is an indication of neo-adjuvant hormonal therapy. 4. no signs of distant metastasis. 5. informed consent. - exclusion criteria: 1. failure to fulfill inclusion criteria. 2. severe hepatic or renal failure, according to clinical and laboratory examinations, serum creatinine \> 225 mmol/l. 3. concomitant diseases that would influence the planned treatment (e.g. inflammatory bowel disease, urinary incontinence, severe atherosclerosis, myocardial infarction within last 6 months. 4. previous diagnosis of other malignant diseases excluding patients who are free from relapse after at least 5 years of diagnosis. patients with basal cell carcinoma are includable. 5. inability of the patient to cope with the study rules, due to abuses, mentalstatus or other reasons 6. participation in other clinical studies at the same time if it considers may hamper the assessment of qol. -

Keywords: curative intention radiation therapy health related quality of life
dementia and disability simulation for college nursing students' senior activity facilitation skills

Conditions: Dementia

Summary: this study aims to evaluate the effectiveness of a dementia and disability simulation (dds) program on dementia knowledge, attitude, empathy, and activity design skills for seniors among college nursing students.

this two-group randomised controlled trial aims to evaluate the effectiveness of a dementia and disability simulation program on dementia knowledge, attitude, empathy, and activity design skills for seniors among college nursing students. the interventional group will receive a 6-week dementia and disability simulation program of activity design for seniors. the control group will receive 6 weeks of regular dementia course and group discussion of activity design for seniors with no dementia and disability simulation. both groups will be assessed for their dementia knowledge, attitude, empathy and activity design skills for seniors at baseline, week 12, and week 18.

Eligibility criteria:
inclusion criteria: * college nursing students with age ranged from 19 to 40 years, * taiwanese nationality, * sophomore and above * provide informed consent to participate in the study. exclusion criteria: -college nursing students who do not meet the inclusion criteria

Keywords: dementia disability simulation nursing student
autologous transplantation of bone marrow mononuclear stem-cells by mini-thoracotomy

Conditions: Dilated Cardiomyopathy

Summary: bone marrow mononuclear cells (bmmc) transplantation is a promising therapy for treating ischemic disease, however the effect in non-ischemic dilated cardiomyopathy is unknown.this study describes a technique of bmmc transplantation utilizing mini-thoracotomy and results up to one year after the procedure.


Eligibility criteria:
inclusion criteria: * diagnosis made at more than two years and symptomatic at functional class iii-iv by the new york heart association classification (nyha) despite optimal pharmacologic therapy * left ventricular ejection fraction (lvef) less than 35%, by echocardiogram * age below 60 years * absence of neoplasm * absence of hematologic disease or systemic disease * no previous cardiac intervention exclusion criteria: * episodes of tachycardia or ventricular fibrillation * severe or moderated mitral insufficiency * any other valvulopathies

Keywords: cardiomyopathy, stem cell, cardiac failure
gh35 tablets for advanced solid tumors: a study on safety and early results

Conditions: Advanced Solid Tumors Harboring With G12C Mutation

Summary: evaluate the safety and tolerability of gh35 in patients with kras mutant advanced solid tumors. estimate the maximum tolerated dose (mtd) and/or a recommended phase 2 dose (rp2d) in patients with kras mutant advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. male or female subjects greater than or equal to 18 years old. 2. histologically or cytologically confirmed diagnosis of advanced/metastatic solid tumor with kras mutation identified. 3. expected survival time ≥12 weeks. 4. eastern cooperative oncology group (ecog) performance status of 0 or 1. 5. must have at least one measureable lesion per response evaluation criteria in solid tumours (recist) version 1.1. 6. have documented disease progression or intolerance after first-line treatment. exclusion criteria: 1. gastrointestinal (gi) tract disease causing the inability to take oral medication. 2. previous accept with kras g12c inhibitor. 3. uncontrollable general infection. 4. serious cardiovascular disease. 5. left ventricular ejection fraction (lvef) \<50 %. 6. known history of hypersensitivity to any of the excipients of gh35 tablets 7. pregnant or nursing (lactating) women.

Keywords: advanced solid tumors, kras
blood flow restricted high-intensity treadmill training on independently ambulating chronic ischemic cva survivors

Conditions: Stroke, Ischemic; Ambulation Disorder, Neurologic; Chronic Stroke

Summary: individuals surviving chronic ischemic stroke have lingering walking deficits long after their infarct. the main goal of this study is to compare two high intensity treadmill walking programs to see which improves walking more. the main question we aim to answer is: how does blood flow restricted high-intensity treadmill training impact walking function? participants will be randomly separated into two groups. one group will perform the high intensity treadmill training with blood flow restriction on their stroke affected leg, while the second group performs high intensity treadmill training only. every week participants will be asked to walk on the treadmill for a total of 75 minutes during 2x 1-hour sessions. on visit 1, participants will undergo strength, balance, and walking testing. they will then be treated 2x weekly for 4 weeks (visit 2-9) and be re-tested to track progress on visit 10. participants will again be treated 2x weekly for 4 more weeks (visit 11-18) and be tested to see the end results on visit 19. researchers will then compare both groups to see if blood flow restriction training changes walking function, strength, and balance.


Eligibility criteria:
inclusion criteria: * adults 18 years or older with history of single ischemic stroke \>6months. * ambulate without physical assistance over 10m with or without mobility aides and bracing in 180 seconds or less. exclusion criteria: * concurrent physical or occupational therapy. * vulnerable populations such as adults unable to consent, individuals who are not yet adults (infants, children, teenagers), pregnant women, prisoners will be excluded. * resting bp \>160/100mmhg even with medication. * people who have taken analgesics, dopamine, antipyretics, and any other drugs that can affect the function of the autonomic nervous system in the last 2 weeks and likely to be treated with such drugs during the course of the study. * individuals who score 9 (greater than normal or minimal impairment) or more on the short blessed cognitive assessment (6 item) will be unable to give informed consent. * any medical condition (including heart failure, unstable angina, aortic stenosis, arrhythmias, hypertrophic cardiomyopathy, depression of st-segment, previous or active deep vein thrombosis (dvt) in the hemiparetic lower extremity, pulmonary embolism (pe), bypass surgery within last 3 months.) that, in the opinion of the investigator, might jeopardize the participants' safety.

Keywords: blood flow restriction training bfr bfrt high intensity treadmill training
a prospective study on the safety and efficacy of robot-assisted pancreaticoduodenectomy

Conditions: Pancreatic Cancer; Common Bile Duct Diseases; Periampullary Carcinoma

Summary: further studies are needed to investigate the prognosis and perioperative safety of patients undergoing robotic-assisted pancreaticoduodenectomy. in this study, clinical data and prognostic data of patients undergoing this procedure were prospectively collected and analyzed to explore its safety and efficacy.

perioperative clinical data and prognostic data of patients undergoing robotic-assisted pancreaticoduodenectomy were collected and analyzed to explore the safety and efficacy of this surgical approach.

Eligibility criteria:
inclusion criteria: * over 18 years old * preoperative imaging suggested the presence of space occupying in the head of the pancreas, ampullary abdomen, and distal common bile duct tumor lesions to be treated with pancreaticoduodenectomy * no distant transfer * no significant vascular invasion was received exclusion criteria: * with tumors of other organs * patients unable to tolerate anesthesia and operation due to serious abnormalities in functions of heart, lung and other important organs * patients found intraoperative peripheral organ metastasis combined with excision of other organs or found intraoperative radical excision could not be performed and underwent palliative drainage surgery or end the surgery * preoperative adjuvant therapy was given

Keywords: robot-assisted pancreaticoduodenectomy safety and efficacy randomized controlled trial
high intensity resistance training combined with blood flow restricted exercise in elite handball players

Conditions: Hypertrophy

Summary: purpose of the study is: to investigate the effects of 8 weeks intervention of high intensity resistance training(hirt) combined with blood flow restricted exercise (bfre) compared to high intensity resistance training alone. detailed description: 30 elite handball players will be randomized into 2 groups of 15 participants each. participants will be evaluated in the week before and the week after an 8-weeks training intervention with 2 weekly sessions. based on their baseline muscle strength the participants will be randomized into two groups: hirt-bfre or hirt-hirt. participants in both groups will perform a full-body training programme of hirt. after the full-body programme, back squat exercise with low intensity and blood flow restriction will be performed to the hirt-bfre group and back squat exercise with high intensity without blood flow restriction will be performed by hirt-hirt. evaluation protocol includes: muscle strength measurement with 1 repetition maximum of back squat and knee extension, muscle mass with dual-energy x-ray absorptiometry, muscle thickness of the thigh with ultra sound measurement, vertical jump height with linear encoder, sprint performance with 30m sprint time.


Eligibility criteria:
inclusion criteria: * age \>= 18 years * ds * minimum of 2 years of resistance training experience * \>\< two resistance training sessions each week * \>\< three handball sessions each week * no injuries that prevent participants to perform test of maximal muscle strength * no injuries, that affects the muscle strength or the ability to train exclusion criteria: * elevated blood pressure (\>140/90) * anabolic steroids or prescription-only medical products with know or potential effect on muscle hypertrophy

Keywords: the focus is blood flow restricted exercise
mind body intervention for chronic migraine headaches

Conditions: Migraines; Chronic Pain

Summary: the goal of this exploratory study is to test a mind-body interventional approach for the treatment of chronic migraines. the main goal is to obtain feasibility information on the protocol which has been used in other similar conditions. we will also evaluate multiple measurement tools in order to optimize a follow-up pilot study evaluating the impact of the protocol on migraines.


Eligibility criteria:
inclusion criteria: 1. adult (≥ 18 years of age) 2. previously diagnosed with migraine headache based on ichd-3 beta criteria 91 3. a score of ≥ 50 on the headache impact test-6 self-report survey (moderate impact) 92 4. presence of migraine headaches at least 5 days per month 5. willing to engage in a mind-body intervention 6. willing/able to participate in remote sessions exclusion criteria: 1. known history or suspicion of headaches due to organic cause (e.g. cancer, sinus infection, head trauma, cerebrovascular disease) 2. diagnosis of other chronic pain syndromes that may cloud assessments (e.g. fibromyalgia, chronic idiopathic neck pain) 3. diagnosis of cognitive impairment or dementia 4. active addiction disorder, e.g. cocaine or iv heroin use, that would interfere with study participation 5. major psychiatric comorbidity (e.g., schizophrenia). anxiety and mild-moderate depression are not considered exclusions.

Keywords: migraines headaches chronic pain
open-label extension study to evaluate the safety and tolerability of wve-120102 in patients with huntington's disease

Conditions: Huntington Disease

Summary: wve-hdsnp2-002 is an open-label extension (ole) study to evaluate the safety, tolerability, pk, pd, and clinical effects of wve-120102 in adult patients with early manifest hd who carry a targeted single nucleotide polymorphism, rs362331 (snp2). to participate in the study, patients must have completed the phase 1b/2a clinical study wve-hdsnp2-001.


Eligibility criteria:
inclusion criteria: 1. patient successfully completed the phase 1b/2a study with wve-120102, wve-hdsnp2-001. exclusion criteria: 1. received an investigational drug other than wve-120102, including an investigational oligonucleotide, within the past 1 year or 5 half-lives of the drug, whichever is longer. 2. inability to undergo brain mri (with or without sedation). 3. clinically significant medical finding on the physical examination other than hd that, in the judgment of the investigator, will make the patient unsuitable for participation in and/or completion of the study procedures.
tecfidera and the gut microbiota

Conditions: Multiple Sclerosis, Relapsing-Remitting

Summary: the primary objective of the study is to determine if dimethyl fumarate (dmf) causes changes in the abundance and diversity of commensal microbiota. the secondary objectives of this study are as follows: to identify if there are differences in the gut microbiota composition between patients that do or do not develop gastro intestinal (gi) adverse events (aes), both pre- and post dmf treatment and to examine if the resolution of gi aes in dmf treated patients is reflected in the gut microbiota.


Eligibility criteria:
key inclusion criteria: * have a confirmed diagnosis of rrms and satisfy the therapeutic indication as described in the local label. * female subjects of childbearing potential who are not surgically sterile must practice effective contraception according to the summary of product characteristics (spc) during their participation in the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. key exclusion criteria: * diagnosis of primary progressive, secondary progressive or progressive relapsing ms. * antibiotic treatment in the last month prior to study entry. * scheduled alteration of diet, including the use of probiotics. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: microbiota dmf gastro intestinal ms
incidence and outcome of acute diverticulitis in finland

Conditions: Acute Diverticulitis

Summary: the incidence of acute diverticulitis (ad), conservative vs. surgical treatment and outcome of patients are studied using national registries and patient charts from two hospitals between years 2009-19.

acute diverticulitis (ad) of colon is increasing in finland. incidence, prevalence and mortality of ad of colon are investigated during 10-year period (2009-2019) in whole country. epidemiological data is compared to data of acute appendicitis. nationwide data of patients with ad are asked from finnish institute for health and welfare (thl). to compare registry-based nationwide data, patient charts from electronic database of two hospitals (mikkeli central hospital and tampere university hospital) are reviewed from same study period. patient characteristics, medication, treatment (conservative vs surgery), recurrence of ad and long-term outcome are recorded.

Eligibility criteria:
inclusion criteria: * all patients with acute diverticulitis (k57) in finland and in two hospitals exclusion criteria: * other reasons for acute or chronic abdominal pain
evaluation of real-world data on the performance of the tecnis odyssey™ iol

Conditions: Cataracts

Summary: retrospective collection of data from medical records, multicenter, post-market clinical follow-up study.


Eligibility criteria:
inclusion criteria: 1. previously bilaterally implanted with tecnis odyssey iol, following cataract extraction; 2. enrollment at least 21 days after second eye surgery; 3. clear intraocular media in each eye. 4. signed consent and data protection documentation necessary to comply with applicable privacy laws pertaining to medical treatment in the governing countries. exclusion criteria: 1. concurrent participation in an interventional clinical trial during the time from which the data will be collected; 2. use of systemic or ocular medication that may affect vision; 3. prior corneal refractive surgery in each eye (i.e., lasik, prk, smile, rk, ck); note: limbal relaxing incisions (lri) are permissible as planned at the time of surgery (intraoperatively) but not postoperatively within the retrospective analysis window; 4. ongoing adverse events in each eye that might impact outcomes during the study visit as determined by the investigator; 5. acute or chronic disease or condition, ocular trauma or surgery that may affect vision in each eye (e.g., clinically significant macular degeneration, glaucoma, cystoid macular edema, proliferative diabetic retinopathy, keratoconus etc.). 6. amblyopia, strabismus, nystagmus in each eye.
effect of saccharomyces cerevisiae in ldl cholesterol

Conditions: Dyslipidemias

Summary: the aim of the study is to evaluate the effect of the consumption of a food supplement (live saccharomyces cerevisiae) on lipidic profile in moderate hypercholesterolemic subjects.


Eligibility criteria:
inclusion criteria: * moderate hypercholesterolemia (ldl cholesterol between 1.3 and 1.9 g/l) with maximum 1 associated cardiovascular risk factor. exclusion criteria: * total cholesterol \> 3.5 g/l (on an empty stomach) * triglycerides \> 3 g/l (on an empty stomach) * familial hypercholesterolemia (iia type) * diabete mellitus treated or not * subjects having consumed drugs known for their impact on lipid metabolism (statines, ezetimibes, colestyramin, fibrate...) in the month before beginning if the study and/or susceptible to consume such drugs during the study * subjects having consumed food supplements or functional foods known for their impact on cholesterolemia (phytosterols, phytostanols, policosanols, beta-glucans...) in the month before the study and/or susceptible to consume such products during the study * subjects having consumed probiotics food supplements in the month before the study and/or susceptible to consume such products during the study * subjects following a low diet regimen (intakes \< 1500 kcal/day) in the month before the study and/or susceptible to start such a regimen during the study * food behaviour disorders diagnosed * subjects with rare serious diseases (rare digestive diseases, renal failure, cardiovascular diseases, tumor...) or having endure a serious surgery * subjects having endure bariatric surgery or having a gastric bypass in place * pregnant or lactating women * women willing a pregnancy excessive alcohol consumption * susceptible to modify their tobacco consumption before the end of the study
monitoring hyperkalemia using point-of-care ai-enabled ecg device among patients with chronic kidney disease stages 3-5

Conditions: Chronic Kidney Disease Stages 3-5

Summary: the clinical trial will be conducted in a real-world outpatients setting with the goal of learning if monitoring serum potassium frequently among patients with moderate-to-advanced stages of chronic kidney disease leading to optimal management of hyperkalemia (the reduced occurrence of serum potassium ≥ 5.5 mmol/l during 1-year follow-up). it will also learn about the adherence of using a mobile monitoring device. participants will: * measure their serum potassium using an ai-enhanced point-of-care ecg device at least once per week * receive health education prompts to reduce intake of potassium rich foods if their eletrocardiogram device measured serum potassium is abnormal * receive alerts to visit nephrology clinic if their eletrocardiogram device measured serum potassium is continuously abnormal


Eligibility criteria:
inclusion criteria: * patients with chronic kidney disease stages 3-5 (egfr: 10 - \<60 ml/min/1.73m²) * patients with regular visits in the study sites to manage their chronic kidney disease (≥ 1 visit per 3 months during the past year before enrollment) * willingness to participate in the study with signed informed consent exclusion criteria: * patients already under kidney replacement therapy or will receive kidney replacement therapy in 6 months * unwillingness or without the ability to monitor hyperkalemia using the study device * patients with heart pacemaker implantated

Keywords: chronic kidney disease hyperkalemia ecg