Kornimate/medical-research-clean huggingface dataset:
3d non-invasive myocardial electrical propagation mapping as a new tool to predict sudden death risk in patients with hypertrophic cardiomyopathy

Conditions: Hypertrophic Cardiomyopathy

Summary: hypertrophic cardiomyopathy (hcm) is very common. the thickened heart muscle can disrupt the normal functioning of the heart's electrical system, resulting in fast or irregular heartbeats. today, there are no reliable means to identify hcm patients at risk of sudden death. the cardioinsight™ has recently been developed by medtronic for non-invasive advanced cardiac mapping system. the cardioinsight™ noninvasive 3d mapping system is a non-invasive mapping system that collects chest ecg signals and combines these signals with ct scan data to produce and display simultaneous, bi-atrial and biventricular, 3-d cardiac maps. it is a monocentric, prospective, comparative and analytical study. 20 hcm patients will be recruited in the national reference center for inherited cardiac diseases of lyon. the 3d-propagation maps of 10 well phenotyped and genotyped hcm patients with previous vf (ventricular fibrillation) will be compared to 10 hcm patients without previous vf. after consent signed, holter ecg, scanner and cardioinsighttm 3d_ecg mapping will be planned in the month following the inclusion. 12-lead ecg, 24h holter ecg, cardiac scanner will be performed as standard procedure of each center in the current health care of the patient. the widespread screening of hcm patients with 3d high-density noninvasive mapping should improve the risk-benefit ratio of implantable defibrillator therapy. it is expected that more patients at risk will benefit from this device.


Eligibility criteria:
inclusion criteria : * hcm patient confirmed by echocardiogram. * patient who signed the consent. * patient benefiting from a social insurance system or a similar system exclusion criteria: * pregnant women, * left ventricular dilation (diastolic \>60 mm diameter) and/or left ventricular systolic dysfunction (lvef \<55%), * prior cardiac surgery, * atrial fibrillation, * renal disease (serum creatinine \>2.0 mg/dl), * primary cardiac valve disease * coronary artery disease * previous recent cardiac scan

Keywords: hypertrophic cardiomyopathy sudden death 3d mapping
a study of rgls8429 in healthy volunteers

Conditions: Healthy Volunteers

Summary: primary objective • to assess the safety and tolerability of single ascending doses of rgls8429 secondary objectives * to identify dose-limiting toxicity (dlt) and to determine the maximum tolerated dose (mtd) of a single sc dose of rgls8429 * to characterize the pharmacokinetic (pk) properties of rgls8429

in this randomized, double-blind, placebo-controlled phase 1 study, a single ascending dose of rgls8429 or placebo will be administered via subcutaneous (sc) injection to healthy volunteers to evaluate the safety, tolerability, and pk of rgls8429.

Eligibility criteria:
inclusion criteria: 1. male or female, 18 to 55 years of age 2. body mass index (bmi) 18 to 35 kg/m2 3. medically healthy, with no clinically significant medical history in the opinion of the investigator 4. estimated glomerular filtration rate (egfr) ≥ 90 ml/min/1.73 m2 5. must understand and consent to the study procedures explained in the informed consent form (icf) and be willing and able to comply with the protocol exclusion criteria: 1. subject is mentally incapacitated or has significant emotional problems 2. any medical condition or social circumstance that, in the opinion of the investigator, may make the subject unlikely to complete the study or comply with study procedures and requirements, or may pose a risk to the subject's safety 3. history or presence of alcoholism or drug abuse within the past 2 years prior to screening 4. participation in another clinical trial and/or exposure to any investigational drug or approved therapy for investigational use within 28 days or 5 half-lives of the investigational drug's dosing, whichever is longer, prior to dosing. the 28-day and 5-half-life windows will be calculated from the date of the last dosing in the previous study to day 1 of the current study.

Keywords: rgls8429 autosomal dominant polycystic kidney disease adpkd
obesity prevention in schoolchildren

Conditions: Overweight; Obesity

Summary: the purpose of this study is to design, implement and evaluate an intervention oriented to change alimentary practices and patterns of physical activity of children through educative activities with parents, teachers and children in school of mexico city.

in mexico, obesity is becoming the most public health problem. the increase in body mass is associated with the changes in the alimentary environment, resources for physical activity in a context of poor health literacy of the population and low efficacy of the health system. schools, as social settings, are a opportunity for obesity prevention. the study includes three phases: 1) evaluation of training, in which the psychological context in which obesity is generated is evaluated. the evaluation will be performed by collection of qualitative and quantitative information, 2) design a strategy from the information obtained. the intervention will include working sessions with teachers, parents and children, establishment of schools in window counseling in nutrition and physical activity and the secretion of a website to not communicate with the public and provide information, 3) evaluation of the strategy in a community trial with two groups of schools, one intervention and one control.

Eligibility criteria:
inclusion criteria: * children students in selected schools * anthropometric diagnostic of normality or overweight * informed consent of parents exclusion criteria: * children with special diet or children with limited motor functioning
effect of oral enteral nutrition in pierre robin syndrome

Conditions: Pierre Robin Syndrome

Summary: this was a randomized controlled study. the infants enrolled were randomly divided into the ioe group (with intermittent oro-esophageal tube feeding, n=25) and the png group (with nasogastric tube feeding, n=23), all receiving systemic therapy. before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

pierre robin syndrome (prs) can cause dysphagia. in china, persistent nasogastric tube feeding (png) is the mainstream choice as nutrition support in the dysphagic infants with prs. however, png is associated with various complications, necessitating the exploration for a safer and more effective nutritional support approach. therefore, this study aims to observe the clinical effect of intermittent oro-esophageal tube feeding (ioe) compared to png in the dysphagic infants with prs who received systemic therapy. this was a randomized controlled study. the infants enrolled were randomly divided into the ioe group (with ioe, n=25) and the png group (with png, n=23), all receiving systemic therapy. before and after 4-week treatment, pulmonary infection, swallowing function, nutritional status and body weight between the two group were compared.

Eligibility criteria:
inclusion criteria: * meeting the diagnostic criteria for pierre robin sequence based on ct and x-ray examinations, combined with clinical manifestations and physical signs. * with spontaneous vaginal birth, aged 1 to 12 months. * with dysphagia screened by the water drinking test and further confirmed by the assessment of dysphagia disorders survey (dds), dysphagia severity scale (dss), or schedule for oral motor assessment (soma) * before the treatment, the tube feeding was required and feasible after evaluation. * stable vital signs. * with nasogastric tubes placed before the treatment. * sufficient human milk could be provided by the mothers of the patients (with the help of a manual suction device). exclusion criteria: * abnormalities in brain development or other neurological lesions. * dysphagia caused by other diseases. * other congenital malformations, such as down syndrome, cleft lip, and palate, etc. * severe systemic disease (such as severe infection, severe hepatic and renal dysfunction). * participants who need to receive other therapy which would potentially affect the result of this study.
a prospective non-interventional study in overactive bladder (oab) patients prescribed betmiga® as part of routine clinical practice

Conditions: Urgency Incontinence; Urinary Bladder Overactive; Overactive Bladder; Urologic Diseases; Urinary Bladder Diseases

Summary: a study to understand the impact of betmiga® on patients quality of life, satisfaction with treatment, how long patients remain on treatment, patterns of healthcare resource utilisation, and safety as prescribed by the physicians in routine clinical practice.

single arm, hybrid model study, observing patients on betmiga under conditions of routine clinical practice, with some element of retrospective data collection 2 years prior to enrolment of the study

Eligibility criteria:
inclusion criteria: * patients who have been diagnosed with oab symptoms at visit 1 of this study. oab is defined by the international urogynecological association (iuga)/international continence society (ics) 2010 joint report as urinary urgency, with or without urinary incontinence, usually with frequency and nocturia, with no proven infection or other obvious pathology. * patients whose physician has made the decision to prescribe betmiga® as part of routine clinical practice and who are about to start treatment. exclusion criteria: * patients who are currently taking betmiga®. * contraindication(s) as per the betmiga® summary of product characteristics (spc).

Keywords: overactive bladder quality of life betanis® betmiga® observational myrbetriq®
imaging trial with i-124-clr1404 in patients with newly diagnosed or recurrent glioblastoma

Conditions: Glioblastoma

Summary: the primary objective of this trial is to determine the optimal dose and imaging time point(s) of i-124-clr1404 in subjects with newly diagnosed and recurrent glioma to be used in future trials.


Eligibility criteria:
inclusion criteria: * newly diagnosed glioblastoma or recurrent/suspected recurrent glioblastoma * scheduled to undergo a clinically-indicated surgery or biopsy (specific cohorts) * ecog performance status of 0 to 2 (appendix c) * 18 years of age or older * has the initiative and means to be compliant with the protocol and be within geographical proximity to make the required study visits * has the ability to read, understand and provide written informed consent for the initiation of any study related procedures (or legal representative) * if female of childbearing potential must have a negative pregnancy test within 24 hours of enrollment * women of childbearing potential and men who are able to father a child, must agree to use an effective method of contraception (e.g., oral contraceptives, double-barrier methods such as a condom and a diaphragm, intrauterine device, norplant, depo-provera) during the study and for 45 days following the last dose of the study drug. exclusion criteria: * ongoing grade 2 or greater toxicities due to previous therapies. however, tolerable grade 2 adverse (e.g. neuropathy) events may be allowed at the discretion of the investigator. * has following laboratory abnormalities * platelets \< 100,000/μl * wbc \< 3000/μl * hematocrit \< 22% * serum creatinine \> 2.5 mg/dl * alt \> 1.5 x uln * bilirubin \> 1.5 x uln * ongoing chronic immunosuppressive therapy * history of hypersensitivity to iodine * any other concomitant serious illness or organ system dysfunction which in the opinion of the investigator would either compromise subject safety or interfere with the evaluation of the safety of the test drug * women of childbearing potential, or men who are able to father a child, unwilling to use a medically acceptable method of contraception during the trial * pregnancy or breast-feeding * inability to comply with the protocol * use of any investigational drug within 4 weeks of dosing (unless a longer time period is required by local regulations or the investigational agent)

Keywords: glioma glioblastoma multiforme pet imaging radiopharmaceutical diagnostic
assessing fatiguability of tongue muscles in ms

Conditions: Muscle Weakness; Fatigue; Multiple Sclerosis; Deglutition Disorders; Exertion; Excess

Summary: multiple sclerosis (ms) patients with subjective dysphagia will be tested for tongue strength fatigue using a strictly defined fatigue paradigm. a maximum of 40 sets will be performed, each set consisting of 5 repetitions of 80% of maximum isometric pressure (mip) at the anterior tongue, followed by a mip at the anterior tongue. cut-off criteria are a mip \<50% of the baseline mip, pronounced subjective discomfort and/or exceeding the allocated test time of 30 minutes.

eligibility is mini-mental state exam-score (mmse) \> 23, a eating assessment tool-score (eat-10) \> 3, or a functional oral intake scale-score (fois) \< 7, or failing the yale swallow protocol.

Eligibility criteria:
inclusion criteria: * proven ms * subjective dysphagia exclusion criteria: * mmse \< 23 * major head and neck surgery * history of cancer
act-ed: randomized controlled trial of act-based eating disorder prevention program

Conditions: Eating Disorder Symptoms; Eating Pathology; Disordered Eating Behaviors

Summary: the goal of this clinical trial is to investigate the efficacy of an online group prevention program developed for women at risk for eating disorders with randomized controlled trial. the main questions it aims to answer are: * does the act intervention lead to a significant difference in disordered eating behaviors among individuals at risk for eating disorders? * does the act intervention lead to a significant difference in body dissatisfaction among individuals at risk for eating disorders? * does the act intervention lead to a significant difference in obsessive-compulsive and borderline personality beliefs among individuals at risk for eating disorders? * does body image flexibility significantly affect the impact of the act intervention on disordered eating behaviors? * do self-as-context, cognitive defusion, and present-moment awareness significantly affect the impact of the act intervention on disordered eating behaviors? participant will: join the online 4-session act-based group program fill the measures at pre-test, post-test and follow-up assessment.


Eligibility criteria:
inclusion criteria: * being a woman aged 18 years or older * exhibiting disordered eating behaviors (ede-q score ≥ 3.03) * experiencing body dissatisfaction (bsq-34 score ≥ 110) exclusion criteria: * current or past diagnosis/treatment for an eating disorder * currently receiving psychotherapy * currently receiving psychiatric medication (not excluded if there has been no change in treatment in the last 6 months) * having chronic psychiatric disorders (e.g. psychosis) * having a substance addiction

Keywords: disordered eating eating pathology prevention eating disorders
low level laser therapy to reduce chronic pain

Conditions: Chronic Pain

Summary: the purpose of this study was to determine whether low level laser light directed at the neck and shoulders could be effective in the temporary reduction of chronic pain in the neck and shoulder region.

chronic neck and shoulder pain arising from osteoarthritis, chronic muscle spasms or thoracic or cervical spine sprain strain can be seriously debilitating. currently available treatment options such as pain relief medication, ice pack, massage, physical therapy and chiropractic are typically of limited effectiveness. more permanent options such as surgery are invasive with long recovery periods and side-effects and complications of their own. low level laser light therapy, with its proven anti-inflammatory ability, offers a simple non-invasive option for the reduction of chronic neck and shoulder pain.

Eligibility criteria:
inclusion criteria: * muscular-skeletal pain in the neck/shoulder region * acute and chronic pain in the neck/shoulder region * restricted range of motion in the neck/shoulder region * fibrosis or scar tissue in the neck/shoulder region * inflammation in the neck/shoulder region * altered function in the neck/shoulder region * muscle strains in the neck/shoulder region * rating of 30 or greater on the 0-100 visual analog scale (vas) pain scale * 18-65 years of age exclusion criteria: * severely herniated disks * pregnancy * taken pain medication within the past 12 hours
treatment options for protease inhibitor-exposed children

Conditions: HIV/AIDS; HIV Infections

Summary: the investigators hypothesize that switching to a regimen based on efavirenz will be as effective and safe as remaining on a regimen based on lopinavir/ritonavir for hiv-infected children. the investigators propose an unblinded randomized clinical trial to evaluate a simplification, protease-inhibitor (pi)-sparing treatment strategy among nevirapine (nvp)-exposed hiv-infected children treated initially with lopinavir/ritonavir (lpv/r). hiv-infected children aged 3-5 years, who have a history of exposure to nvp as part of prevention of mother-to-child hiv transmission (pmtct), initiated lpv/r-based therapy in the first 36 months of life or who were enrolled on the control arm of neverest 2 and who are virally suppressed with a viral load \ 1000 copies/ml) on the efv-based regimen will reinitiate the lpv/r regimen. the primary objective is to test whether the durability of viral suppression is equivalent when children are switched to efv-based therapy. the primary study endpoint is failure to have hiv rna \ 1000 copies/ml. secondary aims include comparison of immune preservation, toxicities, selection of resistance mutations, and adherence across the two arms. antiretroviral drug concentrations and adherence will be investigated as possible explanations for the success and/or failure of this simplification regimen. the overall goal of the study is to contribute to the evidence base to allow expansion of treatment options for hiv-infected children in low resource settings.


Eligibility criteria:
inclusion criteria: * hiv-infected child 3 to 5 years of age at time of screening for this trial if enrolled from outside or any age if enrolled from control arm of neverest ii. * reliable history or documented exposure to nvp used as part of pmtct * initiated antiretroviral therapy with lpv/r at age less than 36 months * receiving lpv/r-based art for at least 12 months * at least one viral load measurement less than 50 copies/ml conducted as part of screening for the study * alt measurement grade i or less (daids toxicity tables 2004) (appendix a). these may be repeated until alts normalize if necessary. exclusion criteria: * prior treatment with any nnrti drug as part of a therapeutic regimen * substitution of other nrti drugs (instead of 3tc and d4t which are the standard first line regimen) will be allowed.
practice of mechanical ventilation in patients with severe brain injury in china

Conditions: Respiration, Artificial

Summary: the mechanical ventilation strategy has changed over years worldwide. several international researches have been conducted to study the association of the use of mechanical ventilation with clinical outcomes. in this prospective, multicenter, cross-sectional survey, the practice of mechanical ventilation among patients with severe brain injury will be investigated in 70 intensive care units in china.


Eligibility criteria:
inclusion criteria: 1. older than 18 years 2. with severe brain injury (including severe traumatic brain injury, ischemic stroke, subarachnoid hemorrhage, spontaneous intracerebral hemorrhage, hypoxic-ischemic encephalopathy, intracranial tumor, intracranial infection and idiopathic epilepsy) 3. mechanical ventilated for at least 24 hours before the time of on-spot survey exclusion criteria: 1. undergoing a spontaneous breathing trial (sbt) at the time of on-spot survey 2. underwent at least once sbt in the preceding 24 hours before time of on-spot survey 3. enrolled in another trial

Keywords: mechanical ventilation epidemiology intensive care unit national survey
a safety and efficacy study of refresh optive® gel drops in patients with dry eye disease

Conditions: Dry Eye Syndromes

Summary: this study will evaluate the safety and efficacy o frefresh optive® gel drops in patients with dry eye disease.


Eligibility criteria:
inclusion criteria: * current use of an artificial tear product * visual acuity of at least 20/32 (while wearing glasses, if necessary). exclusion criteria: * use of contact lenses in the last 3 months, or anticipated use of contact lenses during the study * cataract surgery, laser-assisted in situ keratomileusis \[lasik\], or photorefractive keratectomy, within the last 6 months * current eye infection or inflammation
efficacy of electroacupuncture (ea) for women with pure stress urinary incontinence (sui)

Conditions: Stress Urinary Incontinence

Summary: the purpose of this study is to preliminarily assess the efficacy of electroacupuncture (ea) for women with pure stress urinary incontinence (sui).

this was a pilot randomized, placebo controlled trial to preliminarily assess the efficacy of ea for women with pure sui. eligible participants were randomly assigned to ea group or sham ea group in a 1:1 ratio via a central randomization system by acupuncturists. participants, outcome assessors and statisticians were blinded to treatment allocation. subject blinding is achieved via the aid of adhesive pads used in both groups, placebo needle with a blunt tip and sham ea electrode lines. assuming a two-sided alpha of 0.05, power of 90%, and a 20% drop-out, a sample size of 36 would be needed for each group. the investigators expanded the sample size to 80 cases (40 cases per group) to increase the reliability of the study. the investigators performed statistical analysis based on the intention-to-treat principle. all patients accepting randomization were included in the analysis. missing data were filled in by the last observed value. student t tests or mann-whitney u tests were used for the comparison of continuous variables; chi-square tests, fisher's exact tests or kruskal-wallis h tests were used to compare categorical variables, as appropriate. for measures collected at two time points, paired t-tests or wilcoxon signed rank tests were used as appropriate. a statistically significant difference was set at p\<0.05.

Eligibility criteria:
inclusion criteria: * eligible women were 40 to 75 years of age, and met the clinical diagnosis recommendations of sui by the international consultation on urological diseases: * involuntary urine leakage on effort, exertion, sneezing or coughing which stopped when the stress ends; * visible involuntary leakage from the urethra synchronous with increased abdominal pressure, or a pad weight gain \>1 g in 1-hour pad test; * without symptoms of urinary frequency and urgency. exclusion criteria: * women were excluded from the study if they met any of the following criteria: \*other type of urinary incontinence (ui) (urge, mixed, or overflow ui, etc); * symptomatic urinary tract infection; * ever received ui or pelvic surgery; * a severity of pelvic organ prolapse ≥ degree 2; * residual urinary volume \>30 ml; * maximum flow rate ≤ 20 ml/s; * limited in walking, stairs climbing and running; * receiving specialized treatment for sui, or taking medicine affecting bladder function; * serious cardiovascular, cerebral, liver, kidney, or psychiatric disease, diabetes, multiple system atrophy, injury of cauda equina, or myeleterosis; * being pregnant or breastfeeding; * with cardiac pacemaker, metal allergy or severe needle phobia; * unlike to give written formed consent.

Keywords: stress urinary incontinence electroacupuncture efficacy