Kornimate/medical-research-clean huggingface dataset:
a study of adjuvant cretostimogene grenadenorepvec for treatment of intermediate risk nmibc following turbt

Conditions: Non Muscle Invasive Bladder Cancer; Urologic Cancer; Bladder Cancer; Urothelial Carcinoma

Summary: this is a phase 3, open-label, randomized trial designed to evaluate the rfs of turbt followed by cretostimogene grenadenorepvec versus turbt followed by surveillance for the treatment of participants with ir-nmibc.

participants will be randomized 1:1 to cretostimogene grenadenorepvec after turbt (arm a) vs surveillance after turbt (arm b). participants in arm a will receive an induction course and then quarterly maintenance courses of cretostimogene through month 13, if there is no disease recurrence. disease status will be assessed using urine cytology, cystoscopy, and directed turbt/biopsy (if indicated) every 3 months for the first 2 years after randomization and then every 6 months for an additional year or until disease recurrence. ct urogram/mru every 12 months. participants in arm b who recur with ir-nmibc after turbt and surveillance will be offered treatment with cretostimogene as per the treatment schedule in arm a.

Eligibility criteria:
inclusion criteria: * pathologically confirmed ir-nmibc, per american urologic association/society of urologic oncology/national comprehensive cancer network guidelines, within 90 days of participant randomization: 1. recurrent lg ta within 12 months of prior lg or hg (hg ta ≤ 3 cm) tumor 2. solitary lg ta \>3 cm tumor 3. multifocal lg ta tumors 4. primary and solitary hg ta ≤3 cm tumor 5. lg t1 tumor * all visible disease removed by turbt within 90 days of study randomization * acceptable baseline organ function exclusion criteria: * high-risk nmibc (e.g., hg t1, recurrent or multifocal hg ta\>3cm tumor(s), cis) * low-risk nmibc (e.g., solitary lg ta ≤3 cm tumor) * disease in the prostatic urethra at any time or in the upper genitourinary tract within 24 months of randomization * muscle-invasive bladder cancer, locally advanced or metastatic bladder cancer * prior treatment with any human adenovirus serotype 5 based therapy (e.g., adstiladrin)

Keywords: urology bladder cancer non muscle invasive bladder cancer intermediate risk non muscle invasive bladder cancer cretostimogene grenadenorepvec
evaluating the clinical efficacy and safety of colflex

Conditions: Personal Satisfaction

Summary: this study is designed to test the safety and efficacy of colflex, an oral spray created by innotech nutrition, on human subjects to measure changes on frequency/duration of colds and sore throats, as well as dental and oral health changes.


Eligibility criteria:
inclusion criteria: * availability to give written consent * age 18-60, men and women (who are not pregnant or nursing) * people in good health * able to follow protocol * must be experiencing a sore throat or cold at least once a year exclusion criteria: * smokers * liver and kidney disease * inflammatory bowel disease * pancreatitis * gallbladder or biliary disease * neurolgical/psychological disease * bleeding disorders * platelet abnormatilies * gastrointestinal disorders that could interfere with fat absorption * serum triglycerides \> 500 mg/dl and/or total cholesterol \> 300 mg/dl * hypertension (systolic blood pressure \>160 mm hg or diastolic blood pressure \> 100 hg * bmi \>30 * consume or planned to consume anticoagulant, hypertension, or lipid lowering medications * reported consumption of more than 2 alcoholic drinks/day or history of alcoholism or drug dependence * reported use of experimental medication within 1 month prior to the trial

Keywords: oral health mouth health halitosis oral bacteria sore throat colds
exercise, heart failure, and type 2 diabetes

Conditions: Heart Failure; Type 2 Diabetes

Summary: the purpose of this study is to understand the differences in how patients with heart failure respond to exercise training compared to patients with heart failure and type 2 diabetes.

the investigators will measure exercise capacity in patients with heart failure or heart failure plus type 2 diabetes prior to and following a 12-week exercise training program (5d/wk, 30 min/d, 60-75% vo2max) to determine whether improvements in exercise capacity in response to exercise training are mitigated in patients with combined heart failure plus type 2 diabetes.

Eligibility criteria:
inclusion criteria: * ≥50 yr of age * new york heart association class ii-iii chf and ejection fraction ≤35% * receiving optimal medical therapy * sedentary (≤ 30 min/wk structured physical activity). * half of volunteers (n=30) will have a diagnosis of type 2 diabetes (chf+t2d). exclusion criteria: * smoking * changes in medication ≤6 wk prior to enrollment * major cardiovascular event or procedure ≤6 wk prior to enrollment * foot ulcers * advanced neuropathy * co-morbidities or other limitations that may interfere with or prevent volunteers from safely completing the exercise training * fixed rate pacemaker * type 1 diabetes mellitus

Keywords: exercise aerobic exercise
down syndrome and effects of foot muscle exercise

Conditions: Pes Planus Down Syndrome Patients

Summary: down syndrome (ds) is a common chromosomal pediatric disorder and accounts for approximately 8 % of all congenital anomalies. children with ds experience delays in cognitive, physical, speech and language development. hypotonity and laxity that is part of its features causes delay on motor acquisition. furthermore it causes musculoskeletal issues and lower extremity malalignment resulting in inefficient and abnormal pattern of movement compromising locomotion and day to day functions therefore, problems for the population further aggravates. combined effects of these factors causes a high level of stress on foot as it provides the foundation for whole body therefore, individuals with down syndrome are at risk for foot alignment problems. pes planus being the most common amongst them and accounts for 91% of the total ds patients diagnosed. pes planus causes alteration in foot kinetics and kinematics that not only interferes significantly with normal daily life activities as balance and gait but also increases the risk of musculoskeletal injuries. hence researchers have shown interest in addressing this condition for the effective management of ds population. conventional treatment approach are the use of insoles, foot orthosis and arch taping however, they fail to produce residual effect. hence the present study is to determine the role of foot muscles exercises in down syndrome having pes planus since its effects are positively recorded in normal population.


Eligibility criteria:
inclusion criteria: * • clinically diagnosed cases of ds including both male and female. * bilateral flexible pes planus on the basis of navicular drop test. * able to follow instructions and adhere to the exercise program. * ambulating independently. exclusion criteria: * • visual or auditory impairment. * lower limb trauma or surgical intervention past six months.

Keywords: down syndrome foot deformities muscle hypotonia pes planus joint laxity exercise training
randomized trial standard of care vascular access strategies for (neo)adjuvant trastuzumab-based breast cancer treatment.

Conditions: Breast Cancer; Cancer

Summary: in the react-vascular access trastuzumab study (react-va), the investigator will use a novel method to allow comparisons of established standard of care vascular access strategies using the "integrated consent model" as part of a pragmatic clinical trial. the investigator wishes to address a non-pharmacologic issue regarding standard of care vascular access devices. peripherally inserted central catheters (picc lines) versus subcutaneously implanted devices (ports).


Eligibility criteria:
inclusion criteria * histologically confirmed primary breast cancer * planned to start trastuzumab based neo/adjuvant therapy: fec-dh or ac-dh, or; dose-dense ac-th, or docetaxel/cyclophosphamide/trastuzumab or docetaxel/carboplatin/trastuzumab, or weekly paclitaxel with trastuzumab. * ≥19 years of age * able to provide verbal consent exclusion criteria • contraindication to central line placement.

Keywords: her2 positive
general practitioners' felt with their patients' death (regidaq)

Conditions: Death

Summary: very few studies are dealing with the way general practitioners feel the death of their patients. main studies about that subject are qualitative. it needs quantitative studies to analyse how is felt general practitioners' patients' death. this is an epidemiologic quantitative cross-sectional study. the studied population is the whole of the general practitioners of the region nouvelle-aquitaine. the primary endpoint is the percentage of the general practitioners which have hard time living with their patients' death. the secondary endpoints are to evaluate the general practitioners' help needing after their patients' death, to evaluate the personal and professional impact of the patient's death, the percentage of general practitioners using chemical aid after their patients' death and to determinate the existence of support facilities to help general practitioners to stand patients' death. the results of that study could help general practitioners to improve their medical practice in the patient's death situation.


Eligibility criteria:
inclusion criteria: * general practitioners from the nouvelle-aquitaine region. * exclusive or joint exercise of general medicine. * none retired exclusion criteria: * retired patricians * students, residents * general practitioners from another region * general practitioners with no general medicine activity

Keywords: general practice death bereavement
a phase 1 study to assess the safety and immunogenicity of jcxh-221, an mrna-based broadly protective covid-19 vaccine

Conditions: COVID-19; Infectious Disease

Summary: the goal of this clinical trial is to learn about, test, and compare jcxh-221 in healthy volunteers. the main aims to answer are: * to assess the safety and tolerability of the jcxh-221 vaccine in healthy adult subjects * to identify an optimal dose for the jcxh-221 vaccine in healthy adult subjects * to assess the humoral immunogenicity of the jcxh-221 vaccine in healthy adult subjects * to characterize the cellular immunogenicity of the jcxh-221 vaccine in healthy adult subjects participants for phase i will be randomized to either jcxh-221 or placebo.

this is a phase 1 study looking to enroll a total of 72 patients. for phase 1, two cohorts will be explored (18-64 age group and 65+ age group) for a total of 72 subjects. the subjects will be enrolled and randomized to either placebo or jcxh-221. a low dose of jcxh-221 will be explored vs placebo for each age group first.

Eligibility criteria:
main inclusion criteria * sex: male or female; female subjects may be of childbearing potential, of nonchildbearing potential, or postmenopausal. * age: 18 years of age or older, at screening. * status: healthy subjects. * subjects must have completed the full doses for primary vaccination with an approved sars-cov-2 vaccine and may have received booster dose(s), with the last vaccination (can be 2nd dose of primary vaccination or booster dose) having occurred at least 4 months prior to enrollment. main exclusion criteria * current or prior symptomatic or asymptomatic sars-cov-2 infection confirmed by an approved or authorized rapid antigen test on day 1 or within 4 months prior to day 1. * subjects with significant exposure (as defined by current cdc guidance) to someone with laboratory confirmed sars-cov-2 infection or covid-19 with the past 14 days prior to the screening visit. * subjects with fever or signs of acute infection at the time of enrollment and vaccination. * subjects who are taking medications that may prevent or treat covid-19. * subjects who received convalescent serum or prior therapeutic antibodies against sars-cov-2 within 4 months before day 1. * subjects with history of myocarditis or pericarditis, or with aes after mrna vaccination that are in nature and severity beyond the common aes expected and necessitating medical intervention. * subjects with active or suspected immunosuppression, immunodeficiency, or autoimmune disease.

Keywords: mrna vaccine covid vaccination healthy subjects
treatment with nutritional eating plan and dietary fibers in adult patients with hiv/aids

Conditions: Dietary Modification; Dyslipidemia; Signs and Symptoms, Digestive; HIV

Summary: to evaluate if nutritional treatment with nutritional supplementation of dietary fiber reduces cholesterol levels and triglycerides (dyslipidemia) in patients with hiv/aids receiving antiretroviral therapy (haart).


Eligibility criteria:
inclusion criteria: * hiv-infected patients * adults (≥ 19 years old) * on highly active antiretroviral therapy (haart) exclusion criteria: * pregnancy * breastfeeding * opportunistic disease

Keywords: diet therapy symbiotic dyslipidemia gastrointestinal symptoms body composition adherence hiv haart
a pilot study to explore the role of gut flora in celiac disease

Conditions: Celiac Disease

Summary: this study seeks to correlate microbiome sequencing data with information provided by patients and their medical records regarding celiac disease.

the goal of this research study is to better understand how the genetic information in subject's microbiome correlates to the information provided in surveys and in medical records regarding celiac disease

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 patients of any age (interest is given to children to compare with mothers). 3. diagnosis of celiac disease 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. participation in any experimental drug protocol within the past 12 weeks 5. treatment with total parenteral nutrition 6. any clinically significant evidence of disease that could interfere with the subject's ability to enter the trial 7. inability to adequately communicate with the investigator or their respective designee and/or comply with the requirements of the entire study
enhanced recovery after surgery (eras) for laparoscopic hysterectomy at low risk endometrial cancer

Conditions: Endometrial Cancer

Summary: enhanced recovery after surgery (eras) programs are designed to achieve early recovery after surgery and a shorter length of stay (los) at hospital. so far there are only three prospective, randomised studies that exclusively analyze patients affected by oncogynecological pathology providing a high level of scientific evidence. to our knowledge, no studies have been conducted specifically on eras pathways in endometrial cancer treated by laparoscopy. this study aims to evaluate whether eras pathways are beneficial for patients with endometrial cancer, particularly among low-risk early endometrial cancer operated by laparoscopy. length of stay (los), perioperative morbidity and mortality, and perioperative quality of life were analyzed comparing both eras and conventional protocols groups.


Eligibility criteria:
inclusion criteria: * patients undergoing laparoscopic hysterectomy for stage 1a and 1b endometrial cancer exclusion criteria: * age under 18 years * asa iv * liver cirrhosis * psychiatric illness * urgent surgery * the patient's desire not to participate.
targeted evaluation, action, & monitoring of traumatic brain injury

Conditions: Traumatic Brain Injury (TBI)

Summary: team-tbi (targeted evaluation, action, and monitoring of traumatic brain injury) is a research study that brings together tbi patients, advanced evaluation methods, and experts in a multi-faceted study to address the heterogeneity of tbi and to evaluate the effects self-help strategies might have on tbi outcomes.

team-tbi (targeted evaluation, action, and monitoring of traumatic brain injury) proposes a new approach to clinical trials in tbi that will: * evolve diagnostic technology \& treatment * improve self-help strategies * lower cost and speed for delivery of effective strategies the team-tbi program proposes an innovative new approach to tbi clinical trials to overcome the limitations of past efforts and achieve long-awaited breakthroughs for tbi survivors. the study will involve a comprehensive 3-4 day intake evaluation, followed by a variety of remotely performed tasks during a 1-6 month follow-up period.

Eligibility criteria:
inclusion criteria: * 18-60 years of age * fluent in english * documented history of tbi or blast exposure since 2001 exclusion criteria: * inability to have mri * pregnancy * history of tia within last 6 months. * presently involved in open litigation
acute effects of trampoline exercises

Conditions: Exercise; Aerobic Exercise

Summary: the aim of the study is to investigate the acute effects of trampoline exercises on balance, proprioception, vertical jump and cognitive functions. as a result of the study, it is thought that trampoline exercises will affect balance, proprioception, vertical jump, cognitive functions and myotonometric properties of the muscle more positively than walking.

30 healthy, volunteer women who meet the inclusion criteria will be included in the study. participants will be divided into two group randomly. the women in the study group will be evaluated before the first trampoline exercise sessions and the acute effect will be evaluated by re-evaluating at the end of the 45-minute (min) session. the control group women will be evaluated and after 45 minutes of walking, they will be evaluated again for the acute effect over the relevant parameters. the evaluations to be made to the participants are given below; * demographic information form (age, height (cm), weight (kg), occupation, education level, previous and present diseases, smoking, etc.) * balance evaluation - y balance test * ankle joint position sense - electrogoniometer * cognitive assessment - stroop test * vertical jump test - tape measure * myotonometric properties of gastrocnemius, tibialis anterior and peroneal muscles- myoton device

Eligibility criteria:
inclusion criteria: * females who agreed to participate in the study voluntarily, * female individuals between the ages of 18-65 years old * females who have mini mental test score more than 25 exclusion criteria: * those with a body mass index (bmi) greater than 30 kg/m², * pregnant women, * those with following problems; neural findings, malignancy, inflammation, arthritis, metabolic bone disease, column vertebralis or lower extremity surgery, cardiovascular system diseases, severe osteoporosis, communication and hearing disorders, chronic diseases such as diabetes, hypertension, * those who illiterate, * individuals who do sports for more than 150 minutes a week, * individuals with a professional sports background, individuals who do sports for more than 150 minutes a week * individuals with a professional sports background

Keywords: balance joint position sense myoton foot and ankle
intravesical lactobacillus for urinary symptoms among people with nlutd who use indwelling catheters

Conditions: Neurogenic Bladder

Summary: the objectives of the proposed research among this population are: 1) to define clinically meaningful change (i.e. differentiating states of health and illness) with respect to urinary symptoms, urine inflammation, cultivable bacteria, and the urine ecosystem; and 2) to determine the optimal intravesical lactobacillus rhamnosusgg (lgg®) dose to be used to reduce urinary symptoms in a future clinical trial.

urinary tract infection (uti) is the most common outpatient infection world-wide, and for people with spinal cord injury (sci) and neurogenic bladder (nb), it is the most common infection, secondary condition, cause for emergency room visits, and infectious cause of hospitalization. despite its prevalence, attempts to ameliorate uti among people with sci are stymied by long-standing diagnostic challenges which arise from evidence gaps around "gold standard" diagnostic tests (urinalysis and urine culture) that have lower sensitivity and specificity for uti in this population. a high prevalence of chronic inflammation leading to persistence of white blood cells (wbc) in the urine confounds the utility of wbc count, pyuria, and leukocyte esterase as biomarkers for uti; nitrites in urine indicate the presence of only specific (but not all) organisms, many of which are present to a greater extent in the urine of people with sci; and people with sci have a high prevalence of asymptomatic bacteriuria. these physiologic changes render the gold standard diagnostic tests less useful for identifying uti in persons with sci. sa1. estimate healthy, asymptomatic state variability of urine ngal (ungal), white blood cells (uwbc), nitrite, cultivable bacteria, and the urinary microbiome. sa2. estimate the effect of intravesical lgg dose on urinary symptoms (primary outcome), ungal, uwbc, nitrites, cultivable bacteria, and the urine microbiome (secondary outcomes).

Eligibility criteria:
inclusion criteria: * neurogenic bladder for at least 6 months; * utilizing indwelling catheterization for bladder management; * women must be premenopausal and not currently menstruating; * community dwelling * physical disability exclusion criteria: * use of prophylactic antibiotics; * instillation of intravesical antimicrobials to prevent uti; * psychologic or psychiatric conditions influencing the ability to follow instructions; * use of oral or iv antibiotics within the past 2 weeks; * sexual activity within the previous 72 hours; * participation in another study with which results could be confounded.

Keywords: indwelling catheter foley catheter suprapubic catheter
reducing hiv risk among adolescents: evaluating project heart

Conditions: HIV; Sexually Transmitted Diseases

Summary: this study evaluates an educational web-based intervention designed to increase adolescent girls' motivation and skills to engage in safer sexual behavior (project heart: health education and relationship training). half of participants will receive project heart and half of participants will receive project growing minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. the ultimate goal of this work is to help girls reduce their risk of hiv and other sexually transmitted diseases and to avoid unplanned pregnancies.

this study evaluates an educational web-based intervention designed to increase adolescent girls' motivation and skills to engage in safer sexual behavior (project heart: health education and relationship training). half of participants will receive project heart and half of participants will receive project growing minds, an attention-matched control website focused on growth mindsets of intelligence and self-regulation. the ultimate goal of this work is to help girls reduce their risk of hiv and other sexually transmitted diseases and to avoid unplanned pregnancies. primary outcomes for this study include 1) acceptability of the program, 2) communication self-efficacy, and 3) communication intentions.

Eligibility criteria:
inclusion criteria: * 10th grade girl * able to read english exclusion criteria: * none

Keywords: condoms sexual abstinence sexual communication