Kornimate/medical-research-clean huggingface dataset:
performance, efficacy and safety of vibrating capsule in aiding constipated individuals

Conditions: Chronic Idiopathic Constipation

Summary: this is a study intended to evaluate the efficacy and safety of the vibrating capsule versus sham non-vibrating capsule on spontaneous bowel movement, in aiding reliving constipated individuals


Eligibility criteria:
inclusion criteria: 1. patients aged 18 years and older. 2. patients with chronic idiopathic constipation according to rome iii criteria and who have not experienced relief of their symptoms from available therapies (osmotic and stimulant laxatives which was used for at least one month at recommended dose). 3. patients with more than 1 bowel movement/2 weeks and \< 3 bowel movement/week. 4. colonoscopy performed in the past 10 years prior to study participation, unless the patients are \<50 years old and without alarming signs and symptoms 5. patient signed icf 6. for women with childbearing potential, adequate contraception exclusion criteria: 1. history of complicated/obstructive diverticular disease 2. history of intestinal or colonic obstruction. 3. history of significant gi disorder. 4. use of following medication: medication that may affect the bowel mobility, prokinetics, anti-depressants, medications for treatment of parkinson disease, opiates, calcium-channel blockers, aluminium/magnesium hydroxids 5. clinical evidence of significant respiratory, cvs, renal, hepatic, biliary, endocrine, psychiatric, neurologic, or presence of abdominal pacemakers. 6. presence of pacemaker. 7. history of, or current eating disorders, such as anorexia, bulimia, or compulsory overeating. 8. diagnosis of mega-rectum or colon, a history of intestinal obstruction, congenital anorectal malformation, clinically significant rectocele, or any evidence of intestinal structural abnormality, including gi resection that affects bowel transit, or any evidence of intestinal carcinoma or inflammatory bowel disease of alarm symptoms such as weight loss, rectal bleeding, or anaemia. 9. history of zenker's diverticulum, dysphagia or a known esophageal stricture 10. chronic use of non-steroidal anti-inflammatory drugs (nsaids) 11. participation in another clinical study in the last 4 months prior to screening. 12. any other condition which in the opinion of the investigator may adversely affect the safety of the patient or would limit the patient's ability to complete the clinical study. 13. women who are pregnant or lactating. -

Keywords: constipation
an assessment of dual site left ventricular endocardial pacing

Conditions: Atrial Fibrillation; Ventricular Tachycardia; Heart Failure

Summary: we are investigating ways to help patients with heart failure, which is caused by damaged hearts which function less well, and cause symptoms of breathlessness, fatigue, lack of energy and swelling. cardiac resynchronisation therapy (crt) pacemakers are used to improve the pumping function of the main heart chamber in certain suitable people with heart failure. crt requires a pacemaker with 2 wires, one placed inside the right heart chamber and one normally placed on the outside of the left heart chamber. these two wires act together to re-time the coordination of the heartbeat, which is known to improve heart function. the investigators are assessing whether they might be able to improve heart function even more by placing two wires on the inside of the left heart chamber, rather than one around the outside. the investigators wish to assess whether: 1. using two wires within the left side of the heart gives a greater increase in heart function than one. 2. it is possible to choose the best spot inside of the heart by measuring the pattern of the heart beat. 3. is it possible to use a different type of heart monitor placed outside the body instead of a monitor wire inside the heart to assess improvement in heart function? they are investigating this in people with hearts that beat less effectively than normal.


Eligibility criteria:
inclusion criteria: * participant is willing and able to give informed consent for participation in the study. * male or female, aged 60 years or above. * having a suitable atrial fibrillation/flutter or ventricular tachycardia ablation procedure * evidence of abnormal left ventricular structure and function, as shown by left ventricular ejection fraction of less than 40% exclusion criteria: * severe peripheral vascular disease (that would make arterial access more risky) * haemodynamic instability (such that a longer procedure is inadvisable)

Keywords: endocardial pacing multi site pacing
topical rapamycin to erase angiofibromas in tsc

Conditions: Angiofibromas; Tuberous Sclerosis

Summary: the study is a multi-center prospective, randomized, double-blind, placebo-controlled evaluation of the safety and efficacy of a topically applied formulation of rapamycin to cutaneous angiofibromas in subjects with tuberous sclerosis complex (tsc). subjects will apply either the topical vehicle containing rapamycin or the topical vehicle alone nightly to their angiofibromas for six months. the primary goal of this study is to evaluate the efficacy of the topical medication for reduction of cutaneous angiofibromas in patients with tsc. the secondary goal of this study is to confirm the safety of the topical medication.


Eligibility criteria:
inclusion criteria: * subjects must be willing and able to comply with all trial requirements. * subject has a diagnosis of tsc and has visible facial angiofibromas. * female subjects of child bearing potential must not be pregnant and must agree to use appropriate contraceptive methods . exclusion criteria: * subject is currently receiving therapy with rapamycin. * subject is receiving any form of immunosuppression or has previously experienced immune dysfunction. * subject is currently participating in or has participated within the last 30 days in a clinical trial involving an investigational drug. * subject has a known hypersensitivity to either the vehicle or rapamycin. * subject is a pregnant or nursing female. * subject has other dermatologic conditions that would preclude or prevent adequate assessment of changes to their facial angiofibromas. * subject has had laser surgery, cryotherapy, or other dermatologic treatment to their facial angiofibromas within the previous 6 months.

Keywords: angiofibroma tuberous sclerosis rapamycin sirolimus mtor
atrial fibrillation in turkey: epidemiologic registry-2

Conditions: Atrial Fibrillation

Summary: atrial fibrillation (af) is one of the most common cause of preventable ischemic stroke and associated with increased cardiovascular morbidity and mortality. our previous after study demonstrated the general epidemiological data about the patients with valvular and nonvalvular af in turkey. however, data is lacking about the use of new oral anticoagulants (noacs), time in therapeutic inr range (ttr) in vitamin k antagonist users and af management modality in our country. in this multicenter trial the investigators aimed to analyze, follow and evaluate the epidemiological data in non-valvular af patients.

atrial fibrillation (af) is the most common cause of preventable stroke and strongly associated with increased cardiovascular morbidity and mortality with a prevalence of 1-2% in general population.the first multicenter trial in af patients in our country, atrial fibrillation in turkey: epidemiologic registry (after) study, showed that 40% of non-valvular af patients were on warfarin therapy with an effective inr rate of 37% and the most frequent cause of warfarin underuse was physician neglect. yet, the use of new oral anticoagulants, time in therapeutic inr range (ttr) in warfarin users and the main management modality (rhythm or rate control) in af patients have not been studied in turkey. therefore, in this multicenter trial, we aimed to assess the extent of effective anticoagulant use (by means of ttr) and epidemiological characteristics of the nonvalvular af patients with the use of new oral anticoagulants (noacs) in clinical practice in addition to increased awareness provided by after study. after-2 study is planned as a prospective, observational and multicenter study with a 6 month and 1-year follow-up of the patients. a total of 4100 patients in 42 centers reflecting the population of the twelve regions of our country according to the nomenclature of territorial units for statistics will be included in the study. the detailed characteristics of the patients with non-valvular af, the rates and kind of oral anticoagulant use, the effect of increased awareness and noacs on anticoagulant use rate, ttr in warfarin using patients and the bleeding risks of the patients will be determined in this study. at the end of the study, we will question the patients in terms of major adverse events and analyze the independent predictors of these events.

Eligibility criteria:
inclusion criteria: * all consecutive adult non-valvular af patients applied to the cardiology clinics with at least one attack of af identified on electrocardiography without rheumatic mitral valve stenosis and prosthetic valve disease exclusion criteria: * patients who will refuse to be a participant or will not sign the consent form

Keywords: atrial fibrillation epidemiology antiocaogulation
ttx-030 single agent and in combination with immunotherapy or chemotherapy for patients with advanced cancers

Conditions: Solid Tumor; Lymphoma

Summary: this is a phase 1/1b study of ttx-030, an antibody that inhibits cd39 enzymatic activity, leading to accumulation of pro-inflammatory adenosine triphosphate (atp) and reduction of immunosuppressive adenosine, which may change the tumor microenvironment and promote anti-tumor immune response. this trial will study the safety, tolerability, pharmacokinetics, and anti-tumor activity of ttx-030 as a single agent and in combination with an approved anti-pd-1 immunotherapy and standard chemotherapies.


Eligibility criteria:
abreviated inclusion criteria 1. advanced solid tumor malignancy or relapsed/refractory lymphoma, or * eligible to receive single-agent pembrolizumab as standard of care, or * eligible to receive single-agent docetaxel as standard of care, or * advanced pancreatic adenocarcinoma and eligible to receive gemcitabine plus nab-paclitaxel as standard of care. 2. age 18 years or older, is willing and able to provide informed consent 3. evidence of measurable disease 4. life expectancy \> 12 weeks and eastern cooperative oncology group (ecog) performance status of 0-1 abbreviated exclusion criteria 1. history of allergy or hypersensitivity to study treatment components. patients with a history of severe hypersensitivity reaction to any monoclonal antibody. 2. use of investigational agent within 28 days prior to the first dose of study treatment and throughout the study 3. receiving high-dose systemic steroid therapy or any other form of immunosuppressive therapy 4. history of severe autoimmune disease 5. uncontrolled intercurrent illness or other active malignancy requiring ongoing treatment

Keywords: cancer metastatic solid tumors advanced solid tumors relapsed/refractory lymphoma prostrate cancer pancreatic cancer monotherapy combination therapy cd39 adenosine pathway immunotherapy immuno-oncology pd-1 checkpoint inhibitor nab-paclitaxel gemcitabine pembrolizumab docetaxel bladder cancer lung cancer
technology to improve the health of resource-poor hispanics with diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: this study evaluates the efficacy and implementation of a telehealth-supported, integrated diabetes group visit program led by community health workers (chws). primary study relates to efficacy and a secondary study addresses mentored implementation.

the number of hispanics diagnosed with diabetes is escalating in the us with disproportionately higher prevalence and complication rates than other ethnicities. chws are a well-established and culturally sensitive means to bridge gaps in care to individuals with diabetes. however chws are often left unsupported, placing patients at risk of substandard care or harm. telehealth is a term used to describe a range of technologies to support healthcare delivery via communication with the patient or a member of the healthcare delivery team. though telehealth has been implemented into diabetes programs for many years, there is a paucity of data showing the use of telemedicine for chw training and support. the primary study (n=89; cohorts 1,2) compares clinical outcomes and treatment satisfaction of individuals who receive diabetes care in a 12-month telehealth supported, integrated chw-led group visit program compared to those in usual care (wait list control). group visits are 6-months and chws contact patients weekly to bimonthly (mobile health (mhealth)) for 12-months. this phase with have two cohort waves, separated by 6-months. the wait list control group for cohort 2 will explore telehealth, clinician-patient encounters. a secondary study (n=59; cohorts 3,4) at a new clinic evaluates the ability to implement the program. in the first phase of the secondary study the research team will conduct a rct of individuals randomized to the diabetes program (intervention) vs usual care (control) to assess clinic feasibility. the clinic team will observe this process and learn the project protocols during phase 1. in the second phase, the clinic team will lead the group visits while the research team mentors them to conduct the project in-person at the group visits and via telehealth each week (zoom video conferencing). another secondary study (n=138; cohort 5) aims to expand the reach of the education and chw intervention for individuals who may not be able to or cannot come to the clinic for group visits. specifically, individuals will received the education from the program monthly via a secure text message video, chws will contact weekly to bimonthly to advocate for their needs, and participants will receive their routine care as usual in the clinic.

Eligibility criteria:
inclusion criteria: * hispanic adults with diabetes, low-income (earn less than/equal to 250% federal poverty level) exclusion criteria: * not able to understand spanish, group visit is not appropriate for care i.e., need individualized care, pregnancy, etc
metabolic phenotypes in childhood obesity

Conditions: Obesity, Pediatric

Summary: this study provides a sound basis towards a better understanding of the biochemical mechanisms behind childhood obesity and its metabolic phenotypes, which will be of great importance towards the development of more personalized prevention and treatment in future.

the aim of this study was to identify the plasma metabolic profile associated with childhood obesity and its phenotypes.. this cross-sectional study was set-up to examine the metabolic profile in fasting plasma samples from 65 overweight and obese (ob) children and 37 normal-weight (nw) controls aged 8 to 18 years. the obtained plasma 1h-nmr spectra were rationally divided into 110 integration regions, representing the metabolic phenotype. these integration regions reflect the relative metabolite concentrations and were used as statistical variables to construct a classification model in discriminating between ob and nw children and adolescents. in addition, two metabolic phenotypes were defined within the ob group, i.e. the metabolically "healthy" obese (mho) and metabolically unhealthy obese (muo) phenotype which are both classified as obese but with respectively, none (mho) or at least two components (muo) of the metabolic syndrome.

Eligibility criteria:
inclusion criteria: * aged 8 to 18 * normal-weight, overweight or obese according to the international obesity task force (iotf) body mass index (bmi) criteria * fasted for at least 8 hours exclusion criteria: * subjects taking any medication or having serious chronic or acute illness within two weeks preceding the clinical examination,

Keywords: metabolic syndrome metabolomics nmr spectroscopy
measuring abdominal wall compliance during gynecologic laparoscopic surgery

Conditions: Pelvic Organ Prolapse

Summary: to measure abdominal wall compliance (awc) during gynaecologic laparoscopy and assess its relation to the pelvic organ prolapse quantification (pop-q) score of the same individual, and determine a relationship if present.

to characterize abdominal wall compliance (awc), sterile reflective markers are attached to the abdominal wall by means of surgical tape, and the movement of these markers will be tracked with an optical tracker device. as during normal surgery, the intra-abdominal pressure (iap) measured by the insufflator device will be recorded and stored on a secure computer with dedicated software. the pelvic organ quantification (pop-q) score for each patient is determined pre-surgery as part of the standard of care. a biomechanical model will use reflective marker displacement (rmd) and iap to calculate awc. the pop-q score will then be used to investigate a relation between awc and degree of prolapse. it is important to state that the trial does not intervene with the standard of care before- and during surgery. the used equipment is non-invasive and only requires about 5 minutes to be set up before the start of surgery. this set up comprises placing the optical tracker in the operating room such that it has a line of sight on the patient's abdomen and attaching the sterile markers to the abdominal wall. therefore the trail does not add any additional risk to the surgery. each patient scheduled for gynecologic laparoscopy will be asked to participate in the study. if the patient wants to participate, she is presented the informed consent form (icf). if both patient and clinician in charge sign the icf, the patient is included in the study. the table below shows the patient specific information stored as part of the study. sample size calculation is based on a previous study (s61346), where we measured vaginal wall stiffness (the inverse of compliance) in patients with varying degrees of prolapse. 20 pop patients and 20 control group patients will be included.

Eligibility criteria:
inclusion criteria: * all patients assigned to gynecologic laparoscopic surgery at uz leuven. exclusion criteria: * patients that are unable to give consent: in case of dementia or other cognitive disorders. * patients that are unable to give consent: when they are unable to read and/or interpret the content of the informed consent form (icf), which is written in dutch. * patients that had had an earlier abdominoplasty or abdominal wall mesh implantation, or other operations that directly affect the biomechanical properties of the abdominal wall.
epidemiological study of out-of-hospital cardiac arrest in guangzhou

Conditions: Cardiac Arrest; Sudden Cardiac Death

Summary: aim this was a population-based retrospective cohort study of ohca. this study intends to retrospectively analyze the data of pre-hospital emergency system in guangzhou for 10 years, explore the incidence trend of ohca in guangzhou for 10 years; through further analysis, we try to explore the time distribution characteristics of ohca in order to understand the epidemiological characteristics and rules of ohca in super large cities in southern china. methods the pre-hospital traffic data in the main urban area of guangzhou emergency medical command center database from 2011 to 2020 were collected. the cases diagnosed as "cardiac arrest" and "sudden death" were screened, and the cases with non-cardiac causes in the diagnosis were deleted. the crude incidence rate and age-standardized incidence rate of ohca were calculated. joinpoint software was used to calculate the changing nodes in the ohca incidence trend, and the annualpercent change (apc) and average annualpercent change (average annualpercent change, apc) of ohca incidence were calculated. aapc). the ohca data were grouped according to the six main urban areas, and the crude incidence rate, asir and changing trend of the six main urban areas were calculated. the data of ohca were grouped by age, and the crude incidence rate, asir and changing trend of each age group were calculated. the data information was divided into groups according to 24 hours a day, 7 days a week, and four seasons. the number of ohca cases in different time periods was statistically described. the data were imported into spss 26.0 for analysis, and mann-kendall test was used to evaluate the statistical significance of the time trend. time rhythm variability was tested for mean distribution using chi-square goodness of fit test.


Eligibility criteria:
inclusion criteria: cases in the database with a secondary diagnosis containing the diagnostic keywords "cardiac arrest" and "sudden death" exclusion criteria: 1. cases where the diagnosis of "cardiac arrest" and "sudden death" includes a diagnosis of a non-cardiac cause such as asphyxiation, suicide, drowning, advanced cancer, trauma, shock, poisoning, cerebral vascular accident, etc; 2. cases with duplicate records of sex, age, time of call, pick-up address and initial diagnosis
multidimensional evaluation of patients' affected by obstructive apnea syndrome (osas) before and after ventilotherapy

Conditions: Obstructive Sleep Apnea; Sleep Disorder; Well-Being, Psychological; Cognitive Impairment; Cognitive Change; Neurologic Signs

Summary: this observational study aims to evaluate multiple dimensions of health in patients with obstructive sleep apnea syndrome (osas), before and after three weeks of ventilotherapy. specifically, the study aims to identify pre- vs post-treatment differences in the following domains: * cognitive performance * blood expression of biomarkers related to neurodegeneration * psychosocial wellbeing thus, patients will complete the following evaluations before (t0) and after (t1) ventilotherapy: * neuropsychological standard assessment * blood sampling * psychosocial self-reported questionnaires

obstructive sleep apnea syndrome is associated with cognitive difficulties, low psychosocial wellbeing and quality of life; however, the possible beneficial contribution of ventilotherapy on these dimensions is not completely clear. ventilotherapy restores brain oxygenation and improve rest, possibly increasing cognitive performances, psychosocial health and quality of life. multidisciplinary approaches to the treatment of osas are rare, although recommended. solid proof of osas comorbidities may encourage clinicians to adopt a holistic perspective of care, leading to better rehabilitative outcomes. also, evidence of the beneficial effects of ventilotherapy could increase patients' compliance to ventilotherapy, which is generally low. the study aims to evaluate multiple dimensions of patient's health before and after three weeks of ventilotherapy, focusing on the cognitive performance, the blood expression of biomarkers related to neurodegeneration, and individual's psychosocial wellbeing. overall, it is expected improved cognitive performances and psychosocial wellbeing after ventilotherapy. also, a reduction in the blood expression of biomarkers related to neurodegeneration (if found before the treatment) is hypothesized, although the limited research in this field requires cautious predictions. comprehensive evidence about osas comorbidity, beyond breath and sleep difficulties, is mandatory to design innovative multidisciplinary rehabilitative approaches in line with a holistic perspective of care. effective multidisciplinary approaches are considered the gold standard in medical care, leading to better treatment outcomes and higher patients' satisfaction. beyond the clear ethical implication of providing higher quality of treatment, multidisciplinary interventions also imply a shared responsibility of treatment, preventing from clinical misjudgments and professionals' burnout.

Eligibility criteria:
inclusion criteria: * osas diagnosis (ahi \> 5) * handedness: right exclusion criteria: * previous ventilotherapy * neurological and/or neurodegenerative conditions * personality disorders, autism spectrum disorders, schizophrenia, psychosis * sleep disorders comorbidities (eg., narcolepsy)