Kornimate/medical-research-clean huggingface dataset:
pilates mat exercises training on functional performance in middle age obese women

Conditions: Obese

Summary: • aim of the study: this study will aim to investigate the effects of a 12-week pilates-mat exercise program on the functional performance in middle age obese women. materials and methods: sixty obese women patients (ages 45-55 years old) with a body mass index (bmi) 30 -34.9 kg/m2.women will be randomly assigned into experimental group(pilates) or control group, (3 times/week, 60 min/session) their age from 45 to 55 yrs. the pilates exercises were performed on mats. the functional performance on one-leg stance (ols), five-times-sit-to-stand (sts) and 6-min walk (6 mw) tests was evaluated before and after the 12-week pilates training or control follow-up period.

one of the major public health challenges of the 21st century is obesity. in simple terms, obesity is an excessive increase in fat mass. since the 1980s, its prevalence has tripled in many countries and the population with weight excess continues to grow at an alarming rate. obesity impacts on morbidity, disability, activities of daily living and increases the risk of developing cardiovascular disease. (ghiotto et.al 2022). in addition, obesity is associated with a risk of decrease in functional capacity and muscle strength. (lakhdar et. al 2023). pilates exercises consist of stretching and endurance movements performed within the range of joint motions at a regulated pace with concentration and deep breathing. this workout is a novel approach to physical training that involves a combination of strength, stretching, and respiratory and muscular motions. it aims to build muscle, enhance cardiac and respiratory indices, and promote weight loss. in contrast to conventional resistance exercises, in which individual muscle groups are trained, pilates exercises require the activation and coordination of several muscle groups. (hushmandi et .al 2023).

Eligibility criteria:
inclusion criteria: * women * bmi between 30 to 34.9 kg/m2 * age will range from 45-55 years old. 1. exclusion criteria exclusion criteria: * cardiac diseases * liver diseases * hypertension * musculoskeletal disease
how to report postoperative outcomes after a paediatric cardiac surgery ?

Conditions: Congenital Heart Disease in Children

Summary: congenital heart disease is a common abnormality in newborns. the marked improvement in the surgical management of congenital heart disease has led to a reduction in postoperative mortality, historically a quality criterion for surgical and resuscitation management. with the improvement of medical knowledge and surgical techniques, mortality is no longer a single quality criterion for a center and the search for other quality criteria is essential.


Eligibility criteria:
inclusion criteria: * minor patients, under the age of 18 * operated at the hus between 01/01/2010 and 03/31/2022 for transposition surgery of the great vessels (arterial switch) with or without civ; or isolated ventricular septal closure * child or holders of parental authority who do not object to the reuse of their data for scientific research purposes. exclusion criteria: * transposition surgery of the great vessels associated with coarctation of the aorta, pulmonary stenosis or any other complex malformation * surgical technique different from the arterial switch for the transpositions of the great vessels * closure of interventricular communication associated with another complex heart malformation (tetralogy of fallot, atrioventricular canal, right ventricle with double outlet, etc.) * child or holders of parental authority who have expressed their opposition to the reuse of their data for scientific research purposes.

Keywords: congenital heart disease abnormality in newborns
iv safelock device functionality in emergency department

Conditions: Intravenous Access

Summary: the purpose of this research study is to evaluate the functionality of the iv safelock in the clinical emergency department setting.


Eligibility criteria:
inclusion criteria: * emergency department nurses who are consenting and willing to perform tasks. * their patient population will include stable patients 18 or over, who present through triage, are medically stable, are able to verbally consent and require intravenous access. exclusion criteria: * emergency department nurses who are unwilling to consent to use iv safelock on their patient population. * the patient population will exclude pregnant patients, children, prisoners, patients with dementia, or any member of protected class as specified by irb. * the patients must be medically stable and not include patients presenting with acute stroke, acute myocardial infarction, severe sepsis or shock.
gene therapy in subjects with biallelic rpe65 mutation-associated retinal dystrophy

Conditions: Biallelic RPE65 Mutation-associated Retinal Dystrophy

Summary: the goal of this clinical trial is to evaluate the safety, tolerability and efficacy of subretinal administration of ft-001 in subjects with biallelic rpe65 mutation-associated retinal dystrophy.

this study is a multi-center, open-label, phase i/ii clinical study to evaluate the safety, tolerability, efficacy, immunogenicity, and in vivo biodistribution characteristics of ft-001 in subjects with biallelic rpe65 mutation-associated retinal dystrophy. assessments will include visual acuity, vector shedding, immunogenicity and adverse events. participants will be monitored for 5 years after treatment.

Eligibility criteria:
inclusion criteria: 1. subjects who are able to understand and sign the icf 2. female or male aged 8-45 years old when signing the icf 3. clinically diagnosed with biallelic rpe65 mutation-associated retinal dystrophy exclusion criteria: 1. other interfering eye diseases 2. presence of any systemic or ocular disease that can cause or likely to cause vision loss 3. there is evidence of obviously uncontrolled concomitant diseases 4. known to have active or suspected autoimmune diseases 5. with active systemic infection under treatment 6. pregnant or lactating women 7. other conditions unsuitable for the study as determined by the investigator

Keywords: ft-001 biallelic rpe65 mutation-associated retinal dystrophy
clinical characteristics of dementias that occur remotely after traumatic brain injury in retired military personnel

Conditions: Dementia; Traumatic Brain Injury (TBI); Mild Cognitive Impairment (MCI); Chronic Traumatic Encephalopathy (CTE); Post-traumatic Stress Disorder (PTSD)

Summary: the objective of this study is to measure the frequency and clinical types of mild cognitive impairment (mci) or dementia that occur among up to 150 military retirees with and without a history of traumatic brain injury (tbi) among residents of the armed forces retirement home, washington d.c. and the veterans home of california-yountville. investigators will compare the characteristics of dementia in those who have had a prior tbi to the characteristics in those without a history of tbi. it is our hypothesis that the dementia or mci among those with prior tbi has distinct neuropsychological features that distinguishes it from those with dementia or mci without a history of tbi.

75 participants with a history of tbi will be the cases (exposed) group. a control group of 75 retirement home residents without a history of tbi who are age-matched to the cases will also be recruited. participants will be evaluated in a single visit, which will include neurological, psychiatric, and cognitive assessment. the evaluation will take approximately 4 hours. in some cases, the evaluation may be split into two 2 hour sessions.

Eligibility criteria:
inclusion criteria: cases (with a history of tbi): 1. ages 50-95 years 2. history of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the ohio state university tbi identification questionnaire-osu tbi-id, and based on dod/va criteria) 3. residence in afrh-washington d.c. or the veterans home of california-yountville 4. mmse score ≥ 20 5. capacity to provide consent to participate in research (assessment made by study physician) 6. ability to read and write english controls (without a history of tbi): 1. ages 50-95 years 2. no history of traumatic brain injury of sufficient severity to have resulted in medical attention (ascertained via the ohio state university tbi identification questionnaire-osu tbi-id) 3. residence in afrh-washington or the veterans home of california-yountville 4. mmse score ≥ 20 5. capacity to provide consent or assent to participate in research 6. ability to read and write english - exclusion criteria: cases (with a history of tbi): 1. history of penetrating brain injury 2. history of disabling neurological or psychiatric condition such as epilepsy (besides posttraumatic epilepsy), multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia controls (without a history of tbi): history of disabling neurological or psychiatric condition such as epilepsy, multiple sclerosis, cortical stroke, hypoxic-ischemic encephalopathy, encephalitis, or schizophrenia -

Keywords: dementia traumatic brain injury (tbi) mild cognitive impairment (mci) chronic traumatic encephalopathy (cte) remote effects of tbi post-traumatic stress disorder (ptsd_
effect of standardized hibiscus sabdariffa tea in seemingly healthy human volunteers

Conditions: Healthy Human Volunteers

Summary: hibiscus sabdariffa tea is commonly used all over the world by healthy individual but the tea is also employed by patients in the management of chronic diseases such as hypertension diabetes, high cholesterol, liver disease etc. several studies in humans and animal have proved the efficacy of hibiscus sabdariffa tea in lowering blood pressure, blood glucose level and serum total cholesterol. but no study exists on the effect of daily consumption of this tea on blood pressure, blood glucose, total cholesterol and other biochemical and hematological parameters in healthy humans. hence this study.

several studies have been carried out on the effect of the water beverage of hibiscus sabdariffa, most focus on hypertensive patients, diabetic patients and obese patient and some studies investigated the hypolipidemic a effect of the water beverage of hibiscus sabdariffa as well as its effect on haematological parameters but mice were used for these studies. little or no investigation has been done to assess the safety of daily consumption of this water beverage of hibiscus sabdariffa on humans. hence, this study aims at investigating the safety in the daily consumption of zobo in humans, monitoring lipid profile, blood pressure, blood glucose, body mass index and haematological parameters such as haematocrit, haemoglobin, total white blood cells and also hepatic indices.

Eligibility criteria:
inclusion criteria: * healthy volunteers only * not on any medications or herbs * no disease condition * females not pregnant * non-smokers exclusion criteria: * below 18yrs or above 40 years * presence of chronic disease * on medications pregnant females
efficacy and safety of robot-assisted endoscopic submucosal dissection for colorectal neoplasm

Conditions: Robot Surgery; Endoscopic Submucosal Dissection (ESD); Colorectal Neoplasms

Summary: the objective of this study is to investigate the role of the flexible auxiliary single-arm transluminal endoscopic robot (faster) system in colorectal endoscopic submucosal dissection (esd) and to validate its superiority over conventional esd in terms of reducing procedural difficulty, shortening procedure time, and enhancing procedural safety. the main questions it aims to answer are: does the use of the faster system improve the dissection speed of the esd procedure? does the use of the faster system reduce the procedure and dissection time, improving the efficacy of the esd procedure? does the use of the faster system reduce the rate of perforation and hemorrhage, improving the safety of the esd procedure? researchers will compare faster-assisted esd and conventional esd to evaluate the safety and efficacy of the faster system. participants will: be randomly assigned to the group with esd using the traditional procedure or to the group with esd assisted by the faster system. keep a diary of their symptoms after the procedure. esd has gained widespread acceptance as the standard method for treating early-stage gastrointestinal cancers. however, esd is a technically demanding and intricate procedure that requires advanced proficiency of operators, with a heightened risk of complications such as hemorrhage and perforation. the inherent challenges of the colorectal esd are further amplified by the thin mucosa, highly tortuous and flexible lumen, and occasional obstruction of lesions by mucosal folds, all of which collectively elevate both the procedural difficulty and the probability of postoperative complications. adequate exposure of the submucosa layer through effective tissue traction is vital for the safe and effective performance of esd. the faster system is designed to overcome this technical difficulty.


Eligibility criteria:
inclusion criteria: * patients aged 18-85. * patients with pathologically verified colorectal neoplasms scheduled to undergo esd. exclusion criteria: * patients have lesions with confirmed or potential deep submucosal invasion or lymph node metastasis or other conditions that are not suitable for endoscopic therapy. * patients with severe underlying diseases precluding endotracheal intubation, general anesthesia, or surgery. * patients have a history of colorectal malignancy with previous radiotherapy or operative treatment leading to changes in colorectal structure. * patients have lesions with local recurrence after endoscopic resection. * patients unable to obtain informed consent.
hiv a6 genome in art unsuccessful patients on dor

Conditions: Virus-HIV

Summary: the aim of the study is to evaluate the efficacy of doravirine (dor) in the second-line therapy for patients infected with hiv-1 sub-subtype a6 and its derivatives and having the mutations to previously used drugs

during the study 60-80 hiv-infected patients in 2-4 investigation sites (aids centers) across russia with proven virological failure on first-line antiretroviral therapy (art) including efavirenz (efv) and nevirapine (nvp) will be enrolled. the blood samples, epidemiological, clinical and demographic data of patients participating in the study must be collected. all participants must provide written informed consent before the start of the study. virological failure on nnrti regimen in all the participants will be confirmed by hiv genotyping. all the patients with confirmed nnrti mutations will be switched to dor instead of efv/nvp in the second-line therapy and enrolled to the study. the primary efficacy endpoints of art with dor will be weeks 8 and 24 (viral load + t-cell count). for all samples with virological failure at weeks 8 or 24 hiv-1 dna sequences (full protease (pr) and partial reverse transcriptase (rt) regions) will be obtained using the in-house test system or commercial kit (central research institute of epidemiology, moscow, russia). in case of virological failure of dor treatment, the analysis of drug resistance mutations will be carried out.

Eligibility criteria:
inclusion criteria: * hiv-infection confirmed * \> 18 years * informed consent signed exclusion criteria: * pregnant women

Keywords: hiv, mutation, resistance
take the fight in supporting and empowering patients with cancer

Conditions: Healthy Subject; Malignant Neoplasm

Summary: this pilot clinical trial studies take the fight in supporting and empowering patients with cancer through their treatment process. patients with cancer are faced with many obstacles created by the current state of the healthcare system. the purpose of take the fight is to train college students, also called patients' navigators or strategists, to assist and support patients to navigate into the healthcare system and receive the care they need. the strategists are matched with patients and attend/coordinate most patients' medical appointments. the strategists also advance communications between the patient and the medical staff to facilitate both the exchange of medical information as well as increase the patient's compliance with treatment. take the fight may improve the health and quality of life outcomes of cancer patients during critical treatment periods by increasing treatment compliance, eliminating barriers to better care, and increasing clinical trial participation.

primary objectives: i. delineate the benefits of and limitations to having take the fight strategists, performing as lay-navigators, as perceived by both the patients and the students. secondary objectives: i. investigate changes in self-reported outcomes for patients and the take the fight strategists. outline: patients receive patient navigation via strategists from the take the fight for 8 weeks. patients also complete interviews regarding perceived physical, logistical, psychosocial, and informational challenges experienced prior to meeting with strategists/navigators and how challenges were addressed by navigator or others, perceived benefits or limitations of navigator assistance. strategists also complete interviews regarding their perceptions on how patients benefited from participation, challenges patients experienced that were directly or indirectly related to their cancer diagnosis and treatment, how these concerns were addressed, barriers to addressing these concerns, and patient health literacy. after completion of study, patients and strategists are followed up for 8-10 weeks.

Eligibility criteria:
inclusion criteria: * patients eligibility criteria * have histologically confirmed cancer * karnofsky performance scale (kps) score of \>= 60 * the ability to understand and be willing to sign an informed consent document * willing to undergo a form of cancer therapy and subsequent follow-up care * strategists inclusion criteria * age \>= 18 years * wake forest university student * have volunteered as a student strategist at comprehensive cancer center of wake forest university (cccwfu); all strategists are required to have gone through take the fight (ttf) training prior to their volunteer work
biomarker for cystic fibrosis

Conditions: Chronic Nasal Congestion; Lung Infection; Breathlessness; Clubbing Toes; Meconium Ileus; Failure to Thrive; Pancreatitis

Summary: international, multicenter, observational, longitudinal study to identify biomarker/s for cystic fibrosis and to explore the clinical robustness, specificity, and long-term variability of these biomarker/s

cystic fibrosis (cyfi) is a progressive hereditary disease with the prevalence of 1 in 2500. cyfi is an autosomal recessive disease caused by pathogenic variant/s in the cftr (cystic fibrosis transmembrane conductance regulator) gene encoding cftr protein. cyfi causes chronic respiratory damage. pulmonary findings occur already in infancy, which raises questions whether obstruction might be congenital. thick, sticky mucus clogs the airways, reduces muco-ciliary clearance and leads to problems with breathing and recurrent bacterial (pseudomonas aeruginosa) infections, which causes over time the formation of scar tissue (fibrosis) and cysts in the lungs.there is no cure for cyfi; however, symptomatic treatment can help relieve symptoms. the aim of this study is to identify biomarkers for cystic fibrosis disease and to explore their clinical robustness, specificity, and long-term variability. an ideal biomarker plays an essential role in the early diagnosis, prediction and therapeutic monitoring of a specific disorder.

Eligibility criteria:
inclusion criteria: * informed consent is obtained from the participant or the parent/ legal guardian * the participant is aged between 2 months and 50 years * the diagnosis of cystic fibrosis is genetically confirmed by centogene exclusion criteria: * informed consent is not obtained from the participant or from the parent/ legal guardian * the participant is younger than 2 months or older than 50 years * the diagnosis of cystic fibrosis is not genetically confirmed by centogene

Keywords: cystic fibrosis biomarker
clinical evaluation of qflu combo test

Conditions: Cough; Myalgia; Nasal Obstruction; Sore Throat; Headache; Fatigue; Fever

Summary: currently effective antivials for influenza treatment are two influenza viral neuraminidase inhibitors, oseltamivir (tamiflu) and zanamivir (relenza). resistance to these drugs is reflected by reduced susceptibility of viral neuraminidase to these drugs. the hypothesis is that the signal ratio of two reagents (with or without a single concentration of the drug) correlates the ic50 value, an accurate measurement of drug resistance but impractical for clinical use.

the study design is to collect samples from participants. a portion of the sample is used for drug resistance detection using the test (qflu combo test) under investigation. the remaining portion of the sample is used for culture. the culture positive samples are used for determination of ic50 values, which is used as a gold standard for defining whether a virus isolate is resistant to a drug or not. the sensitivity and specificity of the qflu test will be calculated by comparing to the gold standard test.

Eligibility criteria:
inclusion criteria: * those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.

Keywords: cough myalgia nasal obstruction sore throat headache fatigue feverishness patients who exhibit flu-like symptoms during a flu season, including cough, myalgia, nasal obstruction, sore throat, headache, fatigue, and/or feverishness.
ole study of carbetocin nasal spray for the treatment of hyperphagia in prader-willi syndrome

Conditions: Hyperphagia in Prader-Willi Syndrome

Summary: to evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg tid) in subjects with pws

this is a long-term, ole study to evaluate long-term safety and tolerability of carbetocin nasal spray (3.2 mg tid) in subjects with pws. subjects who complete the antecedent double-blind study (acp-101-302) will be invited to participate in the present study.

Eligibility criteria:
inclusion criteria: * has completed the week12/eot visit of the antecedent, study acp-101-302 * met all entry criteria for the antecedent study * may benefit from long-term treatment with open-label carbetocin in the judgment of the investigator. * lives with a caregiver who understands and is willing and able to adhere to study-related procedures and is willing to participate in all study visits. exclusion criteria: * history of, or current, cerebrovascular disease, brain trauma, epilepsy, or frequent migraines. a history of febrile seizures is not exclusionary. * active psychotic symptoms, a history of psychotic symptoms, or a psychotic disorder * history of suicide attempt or inpatient psychiatric hospitalization * has a clinically significant abnormality in vital signs at baseline * has an average qtcf interval of \>450 ms on the baseline ecg performed before the first dose of carbetocin is given in the present study (i.e., the ecg performed at the eot visit of the antecedent study) * has developed a clinically significant ecg finding during the antecedent study * subject is judged by the investigator or the medical monitor to be inappropriate for the study due to aes, medical condition, or noncompliance with investigational product or study procedures in the antecedent study additional inclusion/exclusion criteria apply. subjects will be evaluated at screening to ensure that all criteria for study participation are met.

Keywords: opel-label extension safety tolerability