Kornimate/medical-research-clean huggingface dataset:
very high power ablation in patients with atrial fibrillation scheduled for a first pulmonary vein isolation

Conditions: Atrial Fibrillation

Summary: this prospective, randomized, controlled, unblinded, multicenter study aims at comparing procedural time between conventional close-guided pulmonary vein isolation (pvi) (35w/50w) versus very high power radiofrequency delivery (90w) in atrial fibrillation patients scheduled for a first pvi.


Eligibility criteria:
inclusion criteria: * patients older than 18 years * patients scheduled for a first pvi only for paroxysmal atrial fibrillation (af) (self-terminating or \ 7d); (patients with paroxysmal af or short-standing persistent af presenting with flutter, who are in need of a cavotricuspid isthmus ablation, are allowed to participate in this trial) * patients willing to sign informed consent exclusion criteria: * patients with long-standing persistent af (long-standing persistent af is defined as having an af episode \>1yr) * previous ablation for af * left atrium antero-posterior diameter \>50 mm (parasternal long axis view, plax) * af secondary to electrolyte imbalance, thyroid disease, or reversible or non-cardiac cause * left atrial appendage (laa) thrombus. laa thrombus can be determined by preprocedural imaging: ct, transesophageal echocardiography or mri. * left ventricular ejection fraction \<35%. * cardiac surgery within the previous 90 days. * expecting cardiac transplantation or other cardiac surgery within 180 days. * coronary percutaneous transluminal coronary angioplasty/stenting within the previous 90 days or myocardial infarction within the previous 60 days. * documented history of a thromboembolic event within the previous 90 days. * diagnosed atrial myxoma. * significant restrictive, constrictive, or chronic obstructive pulmonary disease with chronic symptoms. * significant congenital anomaly or medical problem that in the opinion of the investigator would preclude enrollment * women who are pregnant or who plan to become pregnant during the study. * acute illness or active infection at time of index procedure * advanced renal insufficiency * unstable angina. * history of blood clotting or bleeding abnormalities. * contraindication to anticoagulation. * life expectancy less than 1 year. * presence of a condition that precludes vascular access. * unwilling or unable to provide informed consent.
natural history in children up to 16 years with mild to profound hearing loss due to mutations in gjb2 / otof genes

Conditions: Sensorineural Hearing Loss, Bilateral; AUNB1; DFNB1A; Congenital Deafness; DFNB9; OTOF Gene Mutation; GJB2 Gene Mutation

Summary: the purpose of this study is to follow the natural history of non-syndromic hearing loss caused by mutations in two genes (gjb2 or otof) in children up to 16 years of age.

the study aims to: * better describe the prevalence of cases of dfnb1a and dfnb9, including the type of mutations, and to assess the clinical course of the disease in children up to 16 years of age who have a mild to profound deafness. * better understand the audiological and genetic characteristics of the participants with congenital versus evolutive dfnb1a and dfnb9 deafness.

Eligibility criteria:
main inclusion criteria: participants meeting all the following main inclusion criteria will be eligible to participate in the study: * aged ≤ 16 years on the date of signed informed consent for cohort 1 and ≤ 10 years for cohort 2; * with a diagnosis of non-syndromic, bilateral, mild to profound, sensorineural hearing loss (according to the american speech language-hearing association); * with documented genotyping results showing mutation(s) in gjb2 or otof genes; * written informed consent as required by local regulations. * either without cochlear implant, or with unilateral or bilateral cochlear implant(s) exclusion criteria: participants presenting with any of the following main exclusion criteria will not be included in the study * other type of deafness, such as unilateral deafness, persistent conductive deafness, malformation syndrome, syndromic deafness, known familial deafness linked to mutations in other genes than otof or gjb2; * documented genotyping results showing pathogenic mutation(s) in other gene(s) than gjb2 or otof genes in the tested panel; * unable and/or unwilling to comply with all the protocol requirements and/or study procedures.
medical treatment of early-enamel carious lesion using different remeneralizing agents

Conditions: Enamel Caries

Summary: medical treatment of early-enamel carious lesion using different remeneralizing agents

medical management of incipient lesions by application of remineralizing agents like fluoride therapy, amorphous calcium phosphate (acp), and casin phosphopeptide amorphous calcium phosphate (cpp-acp) has proved to be effective in reversing such lesions. fluoride was considered the "gold standard" remineralizing agent , however several recent researchers found that; the ideal remineralizing agents should diffuse or deliver calcium and phosphate ions into early enamel lesion. calcium-silicate based material such as β-casio3 and β-ca2sio4 play an important role in hard tissue regeneration, showing good bioactivity and biocompatibility and can induce bone like apetite formation in stimulated body fluids. when β-casio3 and β-ca2sio4 come in contact with saliva it will be dissolve forming silanol group (si-o ) on the enamel surface which can bind to ca ions and inducing the precipitation of hydroxyapatite. in the light of this, this study was designed to compare the remineralization potential of silver diamine flouride/ potassium iodide, casin phosphopeptide amorphous calcium phosphate and experimental tricalcium silicate on early enamel lesions.

Eligibility criteria:
inclusion criteria: * patients with early enamel lesions (icdas score 1 and 2). * patients with normal occlusion . * patients must have a good oral hygiene * patients free from any systemic diseases and don't receive any medication exclusion criteria: * smoker patients * pregnant females * patients with bad oral hygiene * patients with enamel defects ( amelogenesis imperfecta, fluorosis, cracks or any developmental defects)

Keywords: enamel remineralization randomized clinical trial experimental tricalcium silicate sillver diamine flouride-potassium iodide
a study of an ad26.rsv.pref-based vaccine and high-dose seasonal influenza vaccine, with and without coadministration, in adults aged 65 years and older

Conditions: Influenza, Human Prevention; Respiratory Syncytial Viruses Prevention

Summary: the purpose of this study is to evaluate the immunogenicity and safety of ad26.rsv.pref-based vaccine and quadrivalent high-dose seasonal influenza vaccine when administered either concomitantly or separately.


Eligibility criteria:
inclusion criteria: * willing and able to adhere to the prohibitions and restrictions specified in this protocol * in the investigator's clinical judgment, the participant must be in stable health at the time of vaccination. participants will be included on the basis of medical history and vital signs performed between informed consent from (icf) signature and vaccination * before randomization, a participant must be not intending to conceive by any methods, postmenopausal or surgically sterile * from the time of vaccination through 3 months after vaccination, agrees not to donate blood * must be willing to provide verifiable identification, have means to be contacted and to contact the investigator during the study * participant must be able to work with smartphones/tablets/computers exclusion criteria: * history of malignancy within 5 years before screening not in the following categories: a) participants with squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix may be enrolled at the discretion of the investigator; b) participants with a history of malignancy within 5 years before screening, with minimal risk of recurrence per investigator's judgement, can be enrolled * known or suspected allergy or history of anaphylaxis or other serious adverse reactions to vaccines or their excipients (including specifically the excipients of the study vaccine) * history of severe allergic reactions (example, anaphylaxis) to any component of the quadrivalent high-dose influenza vaccine, including egg protein, or following a previous dose of any influenza vaccine * has abnormal function of the immune system resulting from either clinical condition, chronic or recurrent use of systemic corticosteroids within 2 months prior to study vaccination, or immunomodulating agents within 6 months prior to study vaccination * per medical history, participant has chronic active hepatitis b or hepatitis c infection * history of acute polyneuropathy (example, guillain-barre syndrome) or chronic idiopathic demyelinating polyneuropathy * has a serious chronic disorder, example, chronic obstructive pulmonary disease or congestive heart failure, end-stage renal disease with or without dialysis, clinically unstable cardiac disease, alzheimer's disease, or has any condition, including conditions placing the participant at high risk for severe influenza, for which, in the opinion of the investigator, participation would not be in the best interest of the participant or that could prevent, limit, or confound the protocol-specified assessments * received vaccination with seasonal influenza vaccine for the current influenza season in the northern hemisphere
predicting peripheral arterial disease in men with erectile dysfunction

Conditions: Erectile Dysfunction; Peripheral Arterial Disease

Summary: erectile dysfunction is a common complaint and is found frequently in men with hyperlipidemia, hypertension, diabetes and those who smoke. ed may also be an early warning of peripheral arterial disease. this study is designed to look for a relationship between the degree of ed and the presence of pad when associated with co-morbid conditions.

erectile dysfunction (ed) is a common complaint in the primary care office. it is frequently found in men with hyperlipidemia, hypertension, or diabetes, and may also be an early warning of peripheral arterial disease. we looked for a relationship between the degree of ed and the presence of pad as measured by the ankle brachial index (abi) associated with co-morbid conditions. men over the age of 50 with hyperlipidemia, diabetes, hypertension, or tobacco use were asked to complete a sexual health inventory for men (shim). an abi was measured using a hand held doppler. 175 men from two urban and three suburban family practices in tidewater virginia participated. outcome measures included shim scores, abi, systolic blood pressure, ldl, hemoglobin a1c and tobacco use. moderate or severe erectile dysfunction (shim \< 11.0) was identified in 44% of participants. more than 12.5% of men with severe ed (shim \< 7.0) had an abi positive for pad at 0.95 or less. the results were adjusted for the presence of hyperlipidemia, hypertension, diabetes and tobacco use. men with hypertension did not demonstrate a significant increase in the frequency of pad compared to diabetics or smokers. neither race nor age was found to increase the prevalence of ed. the complaint of erectile dysfunction in men over age 50 should prompt a physician to consider peripheral arterial disease. a simple self-administered shim test should help identify men at risk for pad and suggest further evaluation if the score is 7.0 or less.

Eligibility criteria:
inclusion criteria: * men 50 years old or older * must have a history of diabetes, hypertension, hyperlipidemia and/or a history of tobacco use exclusion criteria: * men younger than 50 years of age * no co-morbid condition such as diabetes, hypertension, hyperlipidemia and/or tobacco use.

Keywords: erectile dysfunction ed peripheral arterial disease pad ankle-brachial index abi
notify (new observations taking information from yesterday)

Conditions: Atherosclerotic Cardiovascular Disease

Summary: this trial will investigate whether notifying patients and their clinicians of the presence of moderate or severe coronary artery calcium on a low-dose ct scan performed for lung cancer screening results in a lower incidence of death, nonfatal myocardial infarction, or nonfatal stroke as compared with practice guideline reminders.


Eligibility criteria:
inclusion criteria: * age \>=18 years * no known ascvd * lung cancer screenee with low dose ct scan (ldct) within the last 5 years * coronary artery calcium (cac) score on ldct \>100 agatston units (au) * not taking a statin or other lipid-lowering therapy (e.g., ezetimibe, bempedoic acid, or pcsk9-lowering therapy) exclusion criteria: * dementia or other neuropsychiatric disorder that interferes with medication adherence * cac scan, coronary ct angiogram, or invasive angiogram since ldct * statin medication intolerance or allergy * life expectancy \<2 years, e.g., metastatic cancer or active cancer undergoing chemotherapy
the effects of neurodevelopmental therapy on feeding and swallowing.

Conditions: Cerebral Palsy

Summary: our study is planned to investigate the effects of neck and trunk stabilization exercises, which are structured from neurodevelopmental therapy method-bobath concept (ndt-b) principles, on feeding and swallowing activity in children with cerebral palsy (cp) who take feeding and oral motor intervention strategies. the cases were divided into two groups, which is the group receiving feeding and oral motor intervention strategies+structured neck and trunk stabilization exercises (n=20) (study group) and those receiving feeding and oral motor intervention strategies (n=20) (control group).

feeding and oral motor interventions address different aspects of feeding difficulties, reflecting the range in specific problems associated with feeding and nutrition in cp. the trunk plays an important role in the organization of postural control and balance reactions because it holds the centre of all body mass and holds therefore, the centre of gravity. the trunk also provides stable attachment points to those muscles that control the head and neck regions. "neck and trunk stabilization exercises" were the basis of static and dynamic balance abilities, and that increased neck and trunk stability might have had a positive effect thereon. to achieve the alignment of the head with the trunk, the pelvis must be stabilized. this has important consequences for the entire process of swallowing. if the head is not stable, then the fine movements of the jaw and tongue needed for feeding will be impaired. with feeding and oral motor interventions and structured neck and trunk stabilization exercises, these parameters are positively affected.

Eligibility criteria:
inclusion criteria: * cases with cerebral palsy who had difficulties in feeding/swallowing skills. * cases who were cooperative without communication barriers and volunteering to participate in the study were included. exclusion criteria: * in the videoendoscopic swallowing study, he/she was not included in the study if he/she had an aspiration or aspiration risk, had advanced vision and hearing loss, used any pharmacological agent to inhibit spasticity, or had undergone orthopaedic surgery or botulinum toxin-a injection in the past six months.

Keywords: neck-trunk stabilization exercise. feeding. swallowing
effect of quadratus lumborum block in c/s

Conditions: Postoperative Pain; Cesarean Section Complications; Block; Patient Satisfaction

Summary: to compare postoperative analgesic effects of usg guided qlb-2 and qlb-3 blocks after c/s. we hypothesized that qlb-3 may be more effective for pain relieving than qlb-2 after c/s.


Eligibility criteria:
inclusion criteria: * pregnancy with a gestation of 37-41 weeks parturients who were scheduled for elective cesarean delivery under general anesthesia * obtained patients informed consent exclusion criteria: * inability to comprehend * bleeding diathesis * allergy to the study agents * localized infection * block failure
a single blind study to evaluate the safety, tolerability and explore the efficacy of 8.0 mg asm8 inhaled daily for 14 days in severe asthma

Conditions: Asthma

Summary: the purpose of the study is to determine the safety and tolerability of 8.0 mg of asm8 when given daily for 14 days by the aeroneb® go nebulizer to subjects with moderate to severe asthma.

the safety and tolerability of asm8 will be assessed by performing a physical exam and vital signs, measuring the use of concomitant medication, routine laboratory tests, urinalysis, sputum analysis, serum il-1 and tnf-α, lung carbon monoxide diffusion capacity, pulse oximetry and measuring aes there are 5 study phases: screening (phase 1), run-in (phase 2), treatment a (phase 3) with active or placebo, treatment b(phase 4) with active or placebo and end of study (phase 5) that includes a wash out period and a final visit.

Eligibility criteria:
inclusion criteria: * be diagnosed with asthma for 3 or more months have moderate to severe asthma as defined by ats criteria exclusion criteria: * no history of pulmonary or health problems for which the investigator considers that participation in this protocol is a risk for the subject
the gluten-casein-free diet in children with autism: a clinical results of the ophthalmic and behavioral manifestations

Conditions: Autism Spectrum Disorder; Ophthalmic Abnormalities

Summary: to evaluate the efficacy of eight weeks of gfcf in children with asd on autistic symptoms and ophthalmic findings such as corneal reflex, interpupillary distance (ipd) and pupil size.

autism spectrum disorder (asd) is a common condition. asd is a heritable illness characterized by early-onset differences in interaction, communication, sensory atypicality, and stereotyped behaviors. recent studies suggest a link between elimination diets and severity of autistic behaviors. the etiology of asd has been still uncertain. therefore, elucidating the underlying pathology may assist in risk assessment and facilitate process management. non-harmful and existing evidence for the diet's benefits in asd must be elucidated. primary study objective: to assess the effect of a gfcf diet on variables autism index, stereotyped behaviors, communication, social interaction associated with asd. the pupillary response can be utilized to anticipate neurological and physiological activities under the surface. changes in light trigger the pupil response, which adjusts the amount of brightness falling on the retina by instinctively constricting or dilating the pupil. atypical pupil size has been linked to abnormal autonomic function in people with asd. disturbances in autonomic functions may also lead to differences in the corneal reflex. this study aimed to obtain more data on the behavioral symptoms and ophthalmic measurements of gluten-free casein-free (gfcf) on asd. in addition, normal development children and children with autism may differ in facial morphology. this study also evaluates the effect of gfcf diet on ipd distance. secondary objectives: to assess the role of gfcf diet in the manifestation of opthalmic measurements such as pupil size, corneal reflex and ipd. 30 children with asd were enrolled in a 8-weeks prospective gfcf diet treatment study. in the study, a single group was evaluated with measurements before and after dietary intervention.

Eligibility criteria:
inclusion criteria: * informed consent / assent, as applicable must be signed prior to executing any study related procedure * children, male or female, 2 to 11 years old (inclusive) * confirmed diagnosis of asd according to the dsm-iv symptom checklist * ability to maintain a gluten- and casein-free diet during the study exclusion criteria: * cardiovascular, psychiatric, autoimmune, cancer, etc. children with secondary different disease * children with any drug use * children currently receiving treatment with any alternative medical methods (eg.hyperbaric). * children with a diagnosis of celiac disease * children who have received any dietary treatment before

Keywords: gluten free casein free diet
effects of melatonin in untreated obstructive sleep apnea

Conditions: Obstructive Sleep Apnea

Summary: the investigators have previously shown that 1 week of 10mg melatonin improves sleep consolidation in untreated obstructive sleep apnea (osa) patients. this study aims to extend on those findings to determine if longer treatment of melatonin improves other outcomes in untreated osa patients.

intermittent hypoxia (low oxygen), sleep fragmentation and restriction are characteristic of obstructive sleep apnea (osa) and cause mental deficits and cardiovascular disease (cvd). melatonin (mlt) is a hormone with sleep promoting properties and the investigators have found 7 days 10mg mlt treatment significantly increases sleep consolidation in untreated osa. thus, melatonin could improve mental function. mlt also has potent antioxidant, anti-inflammatory and anti-hypertensive properties. in humans with cvd and metabolic disorder exogenous mlt improves a wide range of cardio-metabolic outcomes. in rat models of osa, mlt completely blocks intermittent hypoxia induced cardiovascular damage and brain cell death. intermittent hypoxia also induces lasting changes in the neural control of breathing, which worsens osa. experimentally antioxidants block the induction of changes to neural control of breathing. thus mlt may also normalize the control of breathing and reduce the severity of osa. given these findings, the hypothesis is that mlt will improve mental function, cardiovascular outcomes and control of breathing in untreated osa.

Eligibility criteria:
inclusion criteria: * moderate-severe osa (ahi ≥15/hr) exclusion criteria: * non-english speakers (due to necessity to complete neurocognitive testing) * other sleep disorders * history of driving or other accidents due to sleepiness or an epworth score (ess)\> 18 * pregnant * smokers (quit ≥ 1 year ago acceptable) * diabetes * cardiac (other than hypertension), pulmonary, renal, neurologic, neuromuscular or hepatic disease * substantial alcohol (\>3oz/day) or use of illicit drugs * psychiatric disorders (other than depression or anxiety) * current mlt use or use within last 6 months * beta blockers, central nervous system depressants or stimulants, anti-inflammatories, anticoagulants, immunosuppressants, vitamins, antioxidants.