Kornimate/medical-research-clean huggingface dataset:
prospective study for 24-months of physical training introduced in lifestyle of patients with fshd : tolerance, sustainability and efficiency of unsupervised training program.

Conditions: Muscular Dystrophy, Facioscapulohumeral

Summary: it is now accepted that physical activity is not deleterious in myopathies, including muscular dystrophies. in patients suffering from facioscapulohumeral dystrophy (fshd), aerobic training has been reported to be associated with physiological and functional positive effects without alteration in quality of life. van der kooi et al. (2005) and cup et al. (2007) studies suggest that the combination of endurance and strength trainings is even more relevant. however, only a few controlled and randomized studies have been conducted on this topic and the impact of such training programs on skeletal muscle regenerative capacities has not been addressed yet. moreover, due to the fact that training programs are mainly performed on short-term supervised periods, there is a lack of knowledge regarding long-term effects, patient's autonomy and whether or not practice of regular exercise can be maintained in patient's daily life. also, only a few experiments report an integrative view of potential benefits of such programs on functional, biological and quality of life.

the present project is the second phase of a study for which the first phase currently financed by afm is in progress and aims to establish a program of adapted physical training performed at the patient's home under supervision. this program was developed in order to try to meet the two following requirements: 1) to be compatible with the daily professional/social activity of patients so it can be integrated in their life routine; 2) to be intense enough so functional benefits can be induced. the first phase is a controlled and randomized study where patients with fshd participate in a 6-months supervised training program combining aerobic and strength training sessions on an ergocycle. this second phase of our research project aims to evaluate whether a long-term integration of this adapted training program into patients' lifestyle is possible. the same tools, same method and same measurements of training program will be used with remote monitoring, less frequent as it was in the first phase, over a period of 24 months. this second experimental work will also be based on multi-factorial evaluations, i.e. biological, physiological, functional, and quality of life questionnaires and remains collaboration between universities of saint etienne (l. féasson), grenoble (b wuyam) and örebro (f kadi) within the rhône-alpes reference centre for rare neuromuscular diseases (jc antoine).

Eligibility criteria:
inclusion criteria: * included in the fshd1 study * social security regimen affiliated * consent form signed exclusion criteria: * severe cardiac or respiratory insufficiency * cardiac pacemaker * morbid obesity (bmi upper to 35) * anti platelet therapy

Keywords: muscular dystrophy facioscapulohumeral physical training exercise
the effect of laparoscopically closing the hernia defect in laparoscopic ventral hernia repair on postoperative pain

Conditions: Ventral Hernias

Summary: introduction: closure of the hernia gap in laparoscopic ventral hernia repair before mesh reinforcement has gained increasing acceptance among surgeons despite creating a tension-based repair. beneficial effects of this technique have sporadically been reported but no evidence is available from randomized controlled trials. the primary purpose is to compare early postoperative activity-related pain in patients undergoing ventral hernia repair with closure of the gap with patients undergoing standard laparoscopic ventral hernia repair (non-closure of the gap). secondary outcomes are cosmesis and hernia-related quality of life (qol) at 30-days and clinical or radiological recurrence and chronic pain after 2 years. material and methods: a randomized, controlled, double-blinded study is planned. based on power calculation we will include 40 patients in each arm. patients undergoing elective laparoscopic umbilical, epigastric, or umbilical trocar-site hernia repair at hvidovre hospital, herlev hospital, or køge hospital, who meet the inclusion criteria, are invited to participate. conclusion: the technique with closure of the gap may induce more postoperative pain, but may be superior with regard to other important surgical outcomes. no studies have previously investigated closure of the gap in the setting of a randomised controlled trial.


Eligibility criteria:
inclusion criteria: * inclusion criteria * elective, primary or recurrent laparoscopic umbilical or epigastric hernia repair, umbilical trocar-site hernia and epigastric hernia repair where laparoscopic hernia repair is no contraindication (i.e. previous laparotomy with anticipated severe and dense adhesions * hernia defect between 2-6 cm measured preoperatively by the surgeon at the out-patient clinic * maximum 1 defect * patients 18-80 years patients with technical failure (where it is not possible to suture the defect) or patients who are reoperated due to complications remain included and will stay in their primary assigned randomization group in order to perform an intention to treat (itt) analysis. exclusion criteria: * open hernia repair * poor compliance (language problems, dementia and alcohol or drug abuse etc.) * fascia defect \>6 cm (largest diameter, evaluated preoperatively and intra-operatively, thus patients are excluded if the defect is found larger intra-operatively) * emergency repair * chronic pain syndrome (chronic back pain, chronic headache, severe dysmenorrhea, fibromyalgia, whiplash or other conditions requiring daily opioid medication) * daily consumption of opioids (for the last 3 weeks up till the operation) * decompensated liver cirrhosis (child-pugh b-c) * if the hernia repair is secondarily to another surgical procedure * if a patient withdraws his/her inclusion consent
evaluation of non-invasive endothelial function in children sickle by vascular ultrasound

Conditions: Sickle Cell Disease

Summary: sickle cell disease (scd) is an inherited disorder characterized by recurrent painful crises with ischemia resulting from vascular occlusion. adults with scd have increased arterial stiffness and reduced flow-mediated dilation (fmd), due to impaired release of substances such as nitric oxide. the present study assess the vascular properties of carotid and brachial arteries in children with scd compared with a control group without cardiovascular risk factors.


Eligibility criteria:
inclusion criteria: sickle cell group : * children with sickle cell syndrome (ss or sc) * children hospitalized in the hematology unit (day hospital) * the girls set must have had a negative pregnancy test. * one of the two holders of parental authority must have signed consent form * children affiliated to a social security scheme or equivalent control group : children recruited in a previous study : * holders of parental authority affiliated to a social security scheme * children recruited during the balance of a heart murmur or a vasovagal reaction * children whose cardiological examination is normal * children having no cardiovascular risk factor exclusion criteria: sickle cell group : * children with intercurrent diseases such as obesity, intra uterine growth retardation (iugr), hypertension, renal failure, infectious diseases (including hiv, hepatitis c) or chronic inflammatory * children who have sickle cell crisis there is less than 1 month. control group : children with intercurrent diseases: obesity, iugr, hypertension, renal failure, infectious diseases (including hiv, hepatitis c) or chronic inflammatory

Keywords: endothelial function flow-mediated dilation vascular elastic properties
insulin-free cow milk formula in prevention of type 1 diabetes associated autoimmunity - findia pilot study

Conditions: Beta-cell Autoimmunity

Summary: the purpose of this study is to determine whether weaning to whey-based hydrolysed formula or essentially bovine insulin free whey-based findia formula instead of standard cow's milk based formula is effective in the prevention of type 1 diabetes associated beta-cell autoimmunity in children at genetic risk of type 1 diabetes.


Eligibility criteria:
inclusion criteria: * hla-conferred genetic susceptibility for type 1 diabetes exclusion criteria: * pre-term, maternal diabetes with insulin treatment

Keywords: type 1 diabetes beta-cell autoantibodies cow's milk formula bovine insulin
studying the impact of medication counselling by community pharmacists in patients starting a treatment with antidepressants

Conditions: Depression; Antidepressant

Summary: the objective of the simca study was to analyse the impact of structured medication counselling by community pharmacists on medication adherence, economic, clinical and humanistic outcomes of depressed primary care patients who started a new treatment with antidepressants. a clustered rct was set up in the surplus network, a pharmacy chain in flanders, belgium. at the time of the start of the study, the surplus network included 97 pharmacies, in all five flemish provinces, including brussels. during pre-trial meetings, all pharmacists were informed about the simca-study and instructed how to approach eligible patients. randomisation was obtained at the pharmacy level by a computerized random-number generator, following a permuted block design (1:1). the surplus network contains a number of local pharmacy chains; stratiﬁcation was used to ensure equal distribution within local pharmacy chains. pharmacists in the intervention group were trained in communication skills related to depression treatment counselling in groups of no more than 10 participants over a single day. in total, 10 training days were scheduled between november and december, 2010. patients were eligible for inclusion in the study if they started using at least one antidepressant drug, if they were at least 18 years old, if they were able to understand and complete dutch questionnaires and if they could be reached by telephone for follow-up. "starting" was defined as not having been prescribed antidepressants over the last six months, which was checked in the pharmacy records. if the patient gave verbal consent to the pharmacist, to be contacted by the research team, the patient was provided with written and oral information about the simca project and a consent form. at the same time an automatic e-mail was generated from the pharmacy software to inform the research team about the patient's willingness to be contacted about the study. the patient was contacted by the research team, as soon as possible to give more information about the study, to ask for informed consent and to schedule a first telephone survey interview. if the patient wished to participate, he/she completed the consent form, and sent it back with the included postage-paid envelope addressed to the research team. upon receipt of the consent form, the recruited patient's prescribing doctor was contacted and asked to complete and return a brief questionnaire to provide the diagnosis and its severity related to prescribing antidepressants. telephone survey interviews based on validated scales were used to collect data at the start of treatment (as close as possible to the time of recruitment), after one month, three months and six months of treatment.


Eligibility criteria:
inclusion criteria: * at least 18 years old * able to understand and complete dutch questionnaires * could be reached by telephone for follow-up exclusion criteria: * used antidepressants over the last six months
impact on glycemic variability in newly onset t2dm patients initiating dapagliflozin plus metformin versus metformin alone

Conditions: Type 2 Diabetes

Summary: this study will compare the effect of dapagliflozin added to metformin vs metformin alone on blood sugar fluctuations of adults with a recent diagnosis of type 2 diabetes (t2d). the duration of the protocol will be 12 weeks. continuous glucose monitoring will be measured before and at the end of the intervention. the questions this protocol will answer include: * is there a difference in blood sugar fluctuations when dapagliflozin is added to metformin compared with metformin alone in adults with type 2 diabetes? * does dapagliflozin added to metformin improve blood glucose control in patients with type 2 diabetes?

this is an open-label randomized clinical trial aimed to compare the effect of dapagliflozin added to metformin vs metformin alone on glycemic variability of adults with a recent diagnosis of type 2 diabetes. the central hypothesis is that the addition of dapagliflozin will lead to a statistically significant improvement in gv parameters compared to metformin alone. a total of 88 adults aged 18-70 years with t2dm and hba1c between 7.5% and 12% while on a stable dose of metformin 2000 mg/day will be enrolled. participants will be randomized in a 1:1 ratio to one of two treatment arms for a duration of 12 weeks. the primary objective is to compare the change from baseline to end-of-treatment in key glycemic variability indices derived from continuous glucose monitoring (cgm) (mean amplitude glucose excursions -mage, time in range), changes in hba1c, fasting blood glucose, lipid profile, bmi, blood pressure, among others.

Eligibility criteria:
inclusion criteria: * subjects \> 18-77 years-old * both male and female * hba1c ≥ 7.5 % and ≤12% * bmi \> 25 and \<45 kg/m2 * type 2 diabetes diagnosis, drug-naive exclusion criteria: * hba1c \> 12% * creatinine clearance ckd-epi: \< 60 ml/min * lada or type 1 diabetes * gestational diabetes * clinically significant disease like: hepatic, hematological, oncological, psychiatric or rheumatic disease. * symptoms of marked uncontrolled diabetes: (marked poliuria or polidipsia + 10% weight loss prior the last 3 months enrollement) * known hypersensitivity to dapagliflozin or any of the excipients of the product * egfr persistently \<45 ml/min/1.73 m2 * unstable or rapidly progressing renal disease * patients with severe hepatic impairment (child-pugh class c) * any major cv event/vascular disease within 3 months prior to signing the consent at enrollment, as assessed by the investigator * for women only - currently pregnant (confirmed with positive pregnancy test) or breast-feeding.

Keywords: dapagliflozin glycemic variability mage diabetes mellitus
efficacy, safety, and tolerability of hts-519 insert in patients with toenail fungus of the big toenail

Conditions: Onychomycosis

Summary: the purpose of this study is to assess the efficacy, safety and tolerability of hts-519 inserts in the treatment of mild to moderate toenail fungus disease of the big toenail.

open label, single-site

Eligibility criteria:
inclusion criteria: * male and females 18 - 74 years of age inclusive * fungal toenail infection of one or both of the large (great) toenails * the nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed) * willingness not to have professional pedicures or application of any nail polish product or nail cosmetics to the toenails after the screening visit exclusion criteria: * history of any significant chronic fungal disease other than onychomycosis or immunocompromised condition * any abnormalities of the nail or previous surgery of the toenail that could prevent a normal appearing nail if clearing of infection is achieved * significant confounding conditions as assessed by the study doctor * participation in any other trial of an investigational drug or device within 30 days or participation in a research study concurrent with this study * no administration of systemic antifungal medications within 6 months prior to screening visit * no application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit * tinea pedis (athlete's foot) that would require systemic treatment other protocol-defined inclusion/exclusion criteria may apply
detrusor underactivity: presentation and urodynamic characteristics

Conditions: Detrusor Underactivity

Summary: detrusor underactivity (du) is a known disease of the muscles of the urinary bladder that defined as a weak contraction of the muscle resulting in a failure to achieve complete bladder emptying. recently, du as a cause of lower urinary tract symptoms in both men and women has been increasingly gaining attention. there is a major issue in differentiation of underactive bladder symptoms and other causes of lower urinary tract symptoms such as detrusor hyperactivity and impaired contractility (dhic), hypersensitive bladder (hsb), detrusor overactivity (do), bladder outlet obstruction (boo) and dysfunctional voiding (dv). urodynamics (uds) is the standard diagnostic tool, it includes invasive recording of the pressure that is produced when the bladder muscle contracts via pressure sensors introduced in the urinary bladder through special types of urethral catheters. this study aims to determine the prevalence of du along with its symptomatic and urodynamics (uds) characteristics of du in jordanian population through a retrospective chart review.


Eligibility criteria:
inclusion criteria: * patients underwent uds from july 2016 to august 2019 exclusion criteria: * patients with neurogenic bladder (nb) due to known underlying neurological disease, history of open pelvic surgery or major abdominal surgery, or using indwelling catheters or clean intermittent catheterization (cic).
gabapentin for post-operative pain control and narcotic reduction in scrotal surgery

Conditions: Non-obstructive Azoospermia

Summary: the use of non-narcotic multi-modal analgesia to be used in the pre-operative, peri-operative and post-operative period to reduce or potentially eliminate narcotic usage following scrotal surgery. research study results have shown that the use of anti-inflammatories in the peri-operative period reduces both pain and narcotic use. the hypothesis is that adding another agent in the multi-modal pathway will further reduce pain and potentially reduce narcotic usage.

this is a double-blinded, placebo-controlled, randomized trial that will recruit patients categorized into two study arms. patients in the gabapentin arm will receive gabapentin 600mg taken pre-operatively and 300mg taken three times a day for 3 days, while patients in the placebo arm will receive a placebo drug taken pre-operatively three times a day for 3 days.

Eligibility criteria:
inclusion criteria: * participants undergoing microsurgical testicular sperm extraction. * participants over 18 years of age who can provide informed consent * participants with no contraindication to the consumption gabapentin or documented allergy/intolerance * participants not currently using opiates for another reason exclusion criteria: * contraindication to the consumption of celecoxib or gabapentin * history of substance abuse (including prior opiate abuse) * narcotic use within last 3 months * any of the following comorbidities: renal failure, heart disease, peptic ulcer disease, cerebrovascular disease, significant liver disease, untreated depression, chronic pain disorder, or bleeding diatheses * medical history or concurrent illness that the investigator considers sufficiently serious to interfere with the conduct, completion, or results of this trial, or constitutes an unacceptable risk to the subject
analysis of the variation of the retinal vascularization after a prolonged effort

Conditions: Retinal Vascular Disorder; Sport Injury

Summary: the cardiovascular parameters of prolonged physical exercice have been studied, but very little data is available about the retinal vascularization. the eye allows in vivo visualization of micro-vascularisation and is considered as an excellent marker of general vascular condition. the marathon is an intense and prolonged exercise (running 42.195 km) in aerobic environment. thus the investigators propose to study the vascular parameters of the retina, before and after this physical exercise. this will allow : 1) to collect information on the physiology of the retinal vascularization to prolonged effort, 2) to detect any retinal damage (haemorrhages, edema, occlusion ...), not known to date. the results may highlight vascular effects related to retinal hypoxia (venous tortuosity, haemorrhage, venous occlusion, hypoxic edema). furthermore the results may urge prevention in this sport more and more democratized. the investigators hypothesized that prolonged physical exercice causes a change in retinal vascularization.


Eligibility criteria:
inclusion criteria: * person registered at the 2019 paris marathon exclusion criteria: * ophthalmological disorders making access to the fundus impossible for both eyes

Keywords: retinal vascularization intense effort oct-a
totally implantable venous access devices: quality of life and body image

Conditions: Neoplasms Undergoing Chemotherapy

Summary: our hypothesis is that totally implantable venous access devices in neoplastic patients modify body image and self-representation. therefore, the purpose of this study is to evaluate the efficacy of psychological intervention on patients undergone this surgical practice.


Eligibility criteria:
inclusion criteria: * neoplastic patients * adults * not visible demolitive interventions * not psychopathological diagnosis * language understanding exclusion criteria: * not neoplastic patients * psychopathological diagnosis * language misunderstanding

Keywords: cancer, quality of life, body-image, subcutaneous-implant
tolerance, pharmacokinetics and preliminary efficacy of t0001 in ra (rheumatoid arthritis)

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to assess the mtd, pharmacokinetics and preliminary efficacy of t0001 in rheumatoid arthritis.


Eligibility criteria:
inclusion criteria: * age 18-45 years old; * diagnosed with active ra; * dmards therapy must not be used for at least 28 days prior to baseline; * if a patient has received nsaids，current nsaids therapy must have been at a stable dose for at least 28 days prior to baseline; * patient or patient's legal representative able to give written informed consent for participation in the trial. exclusion criteria: * acute or chronic infection, or history of active tuberculosis; * history of diseases of central nervous system, cardiovascular system, kidney, liver ( specified liver function index), digestive system, respiratory system , metabolism system; * patients who have a high risk of infection (with a current infectious disease, a chronic infectious disease, a history of serious infectious disease); * patients who use 5 unit doses tuberculin skin test are positive( 48-72 hour scleroma reading≥5mm); * patients who currently have, or who have a history of, malignancy; * patients who lack of understanding ,communication or collaboration, and can't comply with the protocols; * female patients who are breastfeeding or pregnant, who are of childbearing potential.