Kornimate/medical-research-clean huggingface dataset:
study in patients with type 2 diabetes who are taking metformin and sulfonylurea, metformin and insulin, or insulin

Conditions: Non-Insulin-Dependent Diabetes Mellitus

Summary: this study will use magnetic resonance imaging (mri) techniques to evaluate changes in fluid volume in the lower legs of diabetic patients who add either pioglitazone or placebo to their current diabetic regimen.


Eligibility criteria:
inclusion criteria: * must have been diagnosed with type 2 diabetes at least three months prior to screening. * must be taking either metformin and a sulfonylurea, metformin and insulin, or insulin only, and doses of these medications must have been stable for at least three months. * must have a body mass index (bmi) of between 24 and 35. * if female, the subject must be post-menopausal. * hba1c levels must be between 7% and 10%. * subjects must be eligible for mri scanning (ie, no metal implants, pacemaker, etc). exclusion criteria: * suffer from claustrophobia. * use of tobacco, nicotine, or illegal drugs of abuse. * use of caffeine within two days prior to each study visit. * hiv, hepatitis, edema, untreated blood pressure problems, heart, lung, nervous system or kidney disease, history of blood clots in the legs, diabetic neuropathy, or untreated thyroid disease. * use of drugs or medications that affect the levels of fluid in the body, such as diuretics.

Keywords: pioglitazone diabetes fluid
influence of minimally invasive thymectomy on the subsequent clinical course of myasthenia gravis

Conditions: Myasthenia Gravis

Summary: the aim of this study is to investigate whether minimally invasive thymectomy achieves comparable efficacy and safety results compared to open thymectomy in patients with myasthenia gravis. the planned investigation is a multicenter observational study based on retrospective (present patient data) and prospective data (questionable outcome data). primary hypothesis: minimally invasive thymectomy is not inferior to open thymectomy in terms of efficacy and safety (non-inferiority study).

based on large cohort studies of the last decades, the thymectomy has become a central component of the immunomodulating therapy in mg patients without thymoma detection. because randomized studies were missing, remained a residual uncertainty on the importance of thymectomy. in the study "randomized trial of thymectomy in myasthenia gravis" (mgtx-study) published 2016 the effectiveness of thymectomy by patients without thymoma detection has been indisputable confirmed. a significant improvement of the patient's complaints and the reduction of the immunosuppressive drugs were particularly evident by early onset mg (eomg) two to three years after performing a complete resection of the thymic tissue. while the mgtx study (with an open operative procedure) was being done, the minimally-invasive thymectomy has gained more and more acceptance. from a surgical point of view, the minimally invasive thoracoscopic procedure represents a gentler alternative. according to the momentaneous clinical-scientific point of view, further studies are necessary to compare both procedures. furthermore, the mgtx study included only patients with generalized mg and positive anti-acetylcholine receptor (achr)-antibodies, who were younger than 65 years, so that the relevance of thymectomy in other important subgroups, such as late onset mg (lomg), the ocular mg (omg), as well as the patients without detected antibodies (seronegative mg patients), who represent about 10 % of whole population of mg patients, is still not clear.

Eligibility criteria:
inclusion criteria: * patients with myasthenia gravis * age ≥18 years exclusion criteria: * a proper communication with the patient is not possible * an informed consent could not be signed * a patient reject a participation or requires breaking up

Keywords: myasthenia gravis robotic-assisted minimally-invasive thymectomy mean daily prednisone dose
safety of t regulatory cell therapy in subjects with covid-19 induced acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome; Covid19

Summary: this study is to evaluate the feasibility and safety of treatment with related donor human leukocyte antigen (hla) matched or haploidentical allogeneic t regulatory cells in patients with covid 19 induced ards. study treatment will be administered in 1 to 2 doses, with the possibility of a second infusion given 14 days after the initial infusion.


Eligibility criteria:
inclusion criteria: * age 18 years to 75 years * all patients at entry are required to be at high risk for the development of ards or receiving mechanical ventilatory support * provision of signed written informed consent from the patient or patients legally authorized representative * only patients who are committed to full life support (do not resuscitate (dnr) allowed) * initiation of study drug within 120 hours of the diagnosis of acute lung injury (ali)/ards * covid positive by pcr testing exclusion criteria: * concurrent illness that shortens life expectancy to less than 6 months * inability to obtain adequate study follow-up * greater than 90 hours since first meeting ards criteria per the berlin definition
autologous endometrial coculture (aecct)

Conditions: Infertility

Summary: the purpose of this study is to determine if the use of autologous endometrial coculture (aecc) in young in vitro fertilization (ivf) patients with poor ovarian reserve improves pregnancy outcome.

young women with poor ovarian reserve are commonly given a poor prognosis for ivf success. standard culture media for fertilizing oocytes (unfertilized eggs) is commonly used in ivf which closely resembles tubal fluid. efforts to create optimal culture conditions for fertilization of human embryos for women with poor quality embryos and/or repeated implantation failures have been developed at our center by using aecc. aecc involves placing a patient's fertilized eggs on top of a layer of cells from her own uterine lining, creating a more natural environment for embryo development and maximizing the chance for ivf pregnancy. the investigators will prospectively randomize young patients (≤ age 38 years) poor ovarian reserve to aecc or no aecc with standard culture media to study pregnancy outcome.

Eligibility criteria:
inclusion criteria: * healthy women undergoing ivf at crmi * age ≤ 38 years * poor ovarian reserve with antral follicle count less than 6 follicles, cycle day 2/3 fsh \> 12 ng/ml, amh \< 0.5 ng/ml exclusion criteria: * healthy women undergoing ivf with male factor, severe endometriosis, or tubal factor infertility * donor patients * contraindications for the use of gonadotropins (i.e. pregnancy, lactation, undiagnosed vaginal bleeding or ovarian cysts) * recent or current medical conditions where the patient is not medically stable to undergo stimulation or egg retrieval, hiv infection, diabetes, cardiovascular disease, gastrointestinal, hepatic disease, renal or pulmonary disease. * any patient who is not a candidate for ivf

Keywords: coculture endometrial biopsy ivf poor responders
standard sleeve pouch versus relatively wide pouch with plication

Conditions: Obesity, Morbid

Summary: three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group a : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group b: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the aim is to test the effect of pilcation on the incidence of leaks and bleeding

three hundred morbidly obese patients candidate for sleeve gastrectomy will divided into equal two groups, group a : will operated by standard sleeve gastrectomy on bougie 36 without plication of stable line and group b: will operated by sleeve gastrectomy on bougie 42 with plication of stable line. the primary outcomes is the incidence of leaks and bleeding which is the main nightmare of sleeve gastrectomy, secondary outcome operative time, weight loss and metabolic effect

Eligibility criteria:
inclusion criteria: * obese patients with bmi more than 40 with or without co-morbidity or more than 35 with co-morbidity * patients fit for laparoscopic surgery * give approval to share in the study exclusion criteria: * patients refused to share in the study * patients unfit for surgery * patients aged less than 18 and older than 60 * patient with previous upper abdominal surgery either for obesity or other diseases * revisional bariatric procedures

Keywords: post sleeve gastrectomy leak post sleeve gastrectomy
prospective evaluation of programmed ventricular stimulation before pulmonary valve replacement in patients with tetralogy of fallot

Conditions: Congenital Heart Disease; Fallot Tetralogy; Ventricular Arrythmia; Pulmonary Valve Regurgitation

Summary: severe pulmonary regurgitation is common in patients with tetralogy of fallot and results in progressive right ventricular dilatation and dysfunction. pulmonary valve replacement is frequent in this population, and percutaneous procedures are increasing. ventricular arrhythmias are a frequent late complication in patients with tetralogy of fallot. the most common critical isthmus of ventricular tachycardias is between the pulmonary valve and the ventricular septal defect patch. while an electrophysiology study is sometimes performed in expert centers before surgical pulmonary valve replacement to guide a surgical ablation if needed, this approach is not recommended in current guidelines. an electrophysiology study should also be considered before percutaneous pulmonary valve replacement, as a part of the critical isthmus may be covered by the prosthetic pulmonary valve. moreover, ablation after percutaneous pulmonary valve insertion exposes patients to the risks of traumatic valve or stent injury and infectious endocarditis. at present, reliable predictors to identify high-risk patients in whom an electrophysiology study should be performed before pulmonary valve replacement are lacking. the aim of this study is to assess prospectively the yield of systematic electrophysiology study and programmed ventricular stimulation before surgical and percutaneous pulmonary valve replacement in patients with tetralogy of fallot.


Eligibility criteria:
inclusion criteria: * all patients with repaired tetralogy of fallot referred for surgical or percutaneous pulmonary valve replacement exclusion criteria: * absence of patient's consent

Keywords: programmed ventricular stimulation catheter ablation electrophysiology study tetralogy of fallot pulmonary valve replacement
performance of aclarusdx® a blood-based transcriptomic test for ad, in french patients newly referred to a memory center

Conditions: Cognitive Impairment; Memory Complaint; Clinical Investigation in Memory Centers

Summary: the purpose of this study is to assess the performance of aclarusdx™, an investigational blood test detecting gene expression information, and intended to help physicians in making an alzheimer's disease diagnosis in patients having memory complaint and/or cognitive impairments.

the objective of this study is to apply aclarusdx™ signature in 600 patients newly referred in french memory centers. only aclarusdx™ will be added to the panel of tests usually performed at the centers to establish diagnosis. aclarusdx™ will be used for investigational use only, not for diagnostic purpose. the ultimate goal is to define the clinical utility of aclarusdx™ to provide physicians with a tool that will help them in making the diagnosis of alzheimer's disease (ad). the primary objective is to estimate the prevalence of positive aclarusdx™ in patients diagnosed ad in the population of primary consultants. this population of primary consultants consists of patients with cognitive impairment and / or a memory complaint requiring specialized exploration using aclarusdx™ blood test and which may be potentially related to multiple and different etiologies. the secondary objectives are: * assess the prevalence of positive aclarusdx™ in relation to other diagnoses (mci, vascular dementia ...) established by the physician investigator at the end of specialized assessment. * identify the demographic factors anamnestic, clinical, biological and imaging associated with positivity of aclarusdx™ * identify the demographic factors anamnestic, clinical, biological and imaging associated with the diagnosis of ad and other diagnoses. * determine the contribution of aclarusdx™ in the usual battery of tests performed for diagnostic approach to alzheimer's disease and to identify a possible association of interest with one or more endpoints (clinical, neuropsychological, brain, biological imaging). * assess: diagnostic status at 6 and 12 months, and the mmse and iadl at 6 and 12 months. * assess the predictive value of aclarusdx™ achieved during the initial visit to the diagnosis of ad is 12 months. * evaluate aclarusdx™ predictive value to 12 months

Eligibility criteria:
inclusion criteria: * male and female adult patients * suffering from cognitive impairment and/or memory complaint and justifying a first clinical investigation at the memory center exclusion criteria: * patient already followed up by the memory center * patient unable to comply with study procedures

Keywords: alzheimer cognitive impairment blood test
helping adults with type 2 diabetes use their health data for healthy diabetes self-management

Conditions: Type 2 Diabetes Mellitus (T2DM)

Summary: day-to-day self-management by adults with type 2 diabetes, including glucose monitoring, taking medications, and healthy habits, is essential to avoid diabetes complications, yet, despite the rapidly expanding availability of wearable glucose and activity monitors, successful self-management remains challenging for many. this research aims to develop and test an approach to help adults use their personal diabetes information from wearable devices to achieve and sustain health diabetes self-management, which will reduce diabetes complications, and improve health and quality of life for people with type 2 diabetes.

mpowerhub trial protocol feasibility will be assessed by randomizing 80 adults with type 2 diabetes and glycemic levels above clinical goals to mpowerhub (mpowerhub platform + continuous glucose monitoring \& activity monitoring), continuous glucose monitor alone, or activity monitor alone for four months. mixed quantitative and qualitative assessments will examine recruitment, engagement, and retention metrics and feedback. finally, changes in self-management behaviors (measured using semi-structured interview) and clinic glycemic levels (obtained from participants' electronic health record or finger-stick by study research staff) from pre- to post-monitoring will be compared between arms.

Eligibility criteria:
inclusion criteria: * received outpatient care in the participating health system in the last 12 months * has a diagnosis of type 2 diabetes mellitus (icd10 codes e08.xx, e09.xx, e11.xx, e13.xx,o24.1x , o24.3x, o24.8x, o24.9x) * last hemoglobin a1c (hba1c) value obtained in the last 6 months was ≥7.5% * currently prescribed at least one non-insulin diabetes medication * able to provide informed consent * able to interact with a simple smartphone application * owns or has access to a smartphone that is able to access an internet website * did not participate a prior study related to this protocol exclusion criteria: * originally was diagnosed with type 2 diabetes before the age of 21 years * has a diagnosis of type 1 diabetes mellitus * has a diagnosis of gestational diabetes without any other diabetes diagnoses * is currently prescribed insulin * currently is using a cgm device * has a diagnosis (active or prior) of schizophrenia or other psychotic/delusional disorder * has a life-limiting severe illness (e.g., chronic obstructive pulmonary disease requiring oxygen) * is pregnant or planning to become pregnant within the next 6 months * has other concerns that may interfere significantly with their ability to participate in the intervention (ongoing health issues, personal events, etc.) * currently is enrolled in another diabetes management intervention study

Keywords: type 2 diabetes mellitus adult glucose monitoring mobile application diabetes self-management activity tracker continuous glucose monitoring empowerment
the efficacy of 308nm excimer laser in white striae

Conditions: White Striae; Excimer Laser

Summary: the purpose of this study is to determine whether 308nm excimer laser therapy are effective in the color correction of white striae.

the use of excimer laser in modified program in white striae during a few months.

Eligibility criteria:
inclusion criteria: * white striae exclusion criteria: * red striae
facial thermography study of levocetirizine versus cetirizine

Conditions: Anti-allergic Agents

Summary: phase iv, human pharmacology, exploratory, randomized, 3-way (3 treatment periods) cross-over, double blind, double dummy, placebo controlled study to compare levocetirizine and cetirizine by means of ir thermography.


Eligibility criteria:
inclusion criteria: * healthy male caucasian subject aged between 18 and 55 years (both inclusive). * subject must have a positive prick test to histamine (wheal diameter ≥ 6 mm with histamine dihydrochloride (100 mg/ml) and ≤ 3 mm with diluent control). exclusion criteria: * history of allergic disease, documented or suspected, including but not limited to: asthma, whether or not considered as allergic; nocturnal cough episode suspected to be of asthma-equivalent nature (three or more consecutive nights resulting in sleep disturbances) ; allergic rhinitis, conjunctivitis or sinusitis; nasal polyposis; dermatitis of the face or neck; drug or food allergy. * any clinically significant vascular disease such as hyper- or hypotension, venous disorder, vasculitis etc. * history of hot flushes and any other vasomotor disorders. * ent infection or upper respiratory tract infection not completely cured at least one week before inclusion. * any known history of laryngeal edema. * nasal structural abnormalities (e.g. deviation of the nasal septum...). * recent immunotherapy * skin irritants or uv exposure 48 hours before each visit.

Keywords: nasal histamine provocation, facial thermography, levocetirizine, cetirizine, xyzal, zyrtec
mother to child transmission of antibody to covid-19 the trab cov-19 study.

Conditions: Antibody; Vaccine; Maternal; Cord

Summary: this is a prospective clinical study aiming to investigate on the transplacental antibody transmission post covid-19 infection during pregnancy.

covid -19 infection has been a significant public health burden as it shifted the paradigm of infectious diseases aiming to control the spread and enhance public immune protection. the introduction of covid -19 vaccination in december 2020 aimed to combat the infection, thus tremendously helping to flatten the disease worldwide. channeling the vaccine for the obstetrics field is one of the hallmark strategies to reduce maternal morbidity and mortality. the efficacy of vaccination for the pregnant lady has been established. however, fetus protection via transmission of the antibody during pregnancy is still uncertain. therefore, this study aims to consolidate further evidence of transplacental antibody post-maternal vaccination aiming for fetal protection following delivery.

Eligibility criteria:
inclusion criteria: * term pregnancies at 37 weeks or more * vaccinated 2 doses * in labour exclusion criteria: * unvaccinated * preterm labour less than 37 weeks * multiple pregnancies

Keywords: covid-19 antibody pregnancy
effects of exercise in patients with lipedema

Conditions: Lipedema

Summary: lipedema is a chronic progressive disease characterized by symmetrical, disproportionate swelling of subcutaneous adipose tissue, which is common in women and mostly seen in the lower extremities and to a lesser extent in the upper extremities. healthy lifestyle approaches including exercise treatments are very important for lipedema patients in order to prevent disease progression. the aim of this study is to investigate the effects of exercise on edema, pain, exercise capacity, lower extremity muscle strength and function in lipedema patients. sociodemographic information of the patients, body composition with tanita innerscan bc-601-cg device, clinical information regarding lipedema, type and stage of lipedema, inspection, palpation findings will be recorded. local tissue water percentage will be assessed using moisturemeter-d compact (mmdc, delfin technologies, kuopio, finland) device, circumference measurement using tape, pain intensity with visual analog scale, pain threshold with baseline brand digital algometer device. muscle strength will be assessed using k-force hand dynamometer. functional exercise capacity will be assessed with the 6-minute walk test (6mwt), and lower extremity dysfunction with the lower extremity functional scale. after the assessments are made, the patients will be randomly divided into 2 groups. the patients in the study group will perform group exercises consisting of warm-up, loading and cool-down periods of 40-50 minutes, 2 days a week for 6 weeks, and strengthening exercises applied to the hip muscles and knee extensors with elastic resistance bands, which are decided according to the level of effort perceived by the patient, 3 sets of 10 repetitions, 2 days a week for 6 weeks. the same assessments will be applied to the patients again at the end of the exercise program. the control group will be re-evaluated after 6 weeks with suggestions regarding lipedema and physical activity level, and the obtained data will be compared.


Eligibility criteria:
inclusion criteria: * having a diagnosis of lipedema, * patients with lipedema stage 1,2 and 3 exclusion criteria: * individuals with cardiopulmonary, rheumatic or neurological diagnoses that have symptoms severe enough to prevent participation in exercise, * history of cancer, surgery or trauma that may affect the circulatory system, * history of liposuction or orthopedic surgery within the last year, * individuals who cannot mobilize independently.

Keywords: lipedema exercise function