Kornimate/medical-research-clean huggingface dataset:
rns® system epilepsy post-approval study

Conditions: Epilepsy

Summary: the purpose of the study is to follow patients with partial onset seizures prospectively over 5 years in the real-world environment to gather data on the long-term safety and effectiveness of the rns system at qualified cecs by qualified neurologists, epileptologists, and neurosurgeons trained on the rns system.

neuropace, inc. is sponsoring a post-approval study (pas) of the rns system device. the rns system is the first fda-approved closed loop responsive neurostimulator designed to reduce the frequency of seizures in individuals with partial onset seizures. the rns system epilepsy pas is a 5 year, non-randomized, open-label, multi-center prospective observational study. data regarding safety and efficacy are collected at enrollment and periodically throughout the 5-year study. the study is designed to assess the long-term safety and effectiveness of the rns system as an adjunctive therapy in reducing the frequency of seizures in individuals 18 years of age or older with partial onset seizures who have undergone diagnostic testing that localized no more than 2 epileptogenic foci, are refractory to two or more antiepileptic medications, and currently have frequent and disabling seizures (motor partial seizures, complex partial seizures and/or secondarily generalized seizures). data from the rns system epilepsy pas will be used to calculate long-term sae rates, median percent change in seizure frequency (from pre-implant retrospective data), as well as other safety and effectiveness endpoints.

Eligibility criteria:
inclusion criteria: a clinical decision to treat the patient with the rns system in accordance with its approved indication for use has been made prior to enrollment in the study. for approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the rns system available at the neuropace website (www.neuropace.com). this post-approval study also has the following additional study related inclusion criteria: * subject or legal guardian is able to provide appropriate consent to participate * subject is able to maintain a seizure diary alone or with the assistance of a competent individual * subject is able to attend clinic appointments in accordance with the study schedule exclusion criteria: per clinician assessment, treatment with the rns system is contraindicated based on current rns system labeling. for approved indication for use and contraindications, refer to current physician labeling and instructions for use (manuals) for the rns system available at the neuropace website (www.neuropace.com). this post-approval study has the following additional study related exclusion criteria: * subject is participating in a therapeutic investigational drug or device study * subject was treated with a vns within the last three months (90 days) * subject is pregnant
lipopolysaccharide metabolism and identification of potential biomarkers predictive of graft-versus-host disease after allogeneic stem cell transplantation

Conditions: Hematologic Diseases; Stem Cell Transplantation

Summary: this study is designed to assess the hypothesis that the lipopolysaccharide (lps) activity index can be quantified early after transplantation, as well as the the phospholipid transfer protein (pltp) activity and these both biological variables are independent variables for predicting the risk of severe graft versus host disease (gvhd).


Eligibility criteria:
inclusion criteria: * hematologic malignancy in complete remission * patients eligible for allogeneic hematopoietic cell transplantation from a related or unrelated donor and after myeloablative or non-myeloablative conditioning. * regular follow-up in the center exclusion criteria: * treatment with a statin in progress * umbilical cord blood transplantation * hemoglobin level less than or equal to 8g / dl * known chronic inflammatory bowel disease or gastroenteritis at the time of inclusion. * chronic enteropathy with clostridium difficile
rutgers pilot for predict- patient lab test

Conditions: SARS-CoV2 Infection

Summary: a pilot study was initiated to assess feasibility of testing asymptomatic dental patients presenting to the oral medicine clinic at rutgers school of dental medicine for sars-cov-2 viral rna using an fda approved rt-pcr test for sars-cov2- an rna rt-pcr assay (accurate diagnostics)

patients with upcoming dental appointments at the oral medicine clinic at rutgers school of dental medicine were contacted to solicit interest in participating in a pilot study to assess feasibility of testing asymptomatic dental patients for sars cov 2 infection using an rna rt-pcr assay. interested subjects completed a previsit survey after confirming their interest electronically. subsequently, they received kit to collect their saliva sample at home along with instructions on how to do so. they were directed to drop off their saliva samples for testing at the dental clinic and signed the consent form at that time. after confirming a negative result, the patients were subsequently triaged over the phone for any symptoms and the following day, presented for their dental visit. on the day of their visit, they were triaged, completed their dental visit and were surveyed to get their feedback on the study procedures and their perceptions of safety.

Eligibility criteria:
inclusion criteria: * adult 18 years or older; reporting to the rutgers school of dental medicine for a dental visit exclusion criteria: * previous participation

Keywords: screening lab-based testing asymptomatic patients perception of safety feasibility
evaluation of digital 3d printed temporary removable partial denture.

Conditions: Partial-edentulism; Temporary Partial Denture; 3D Printing; Oral Health Related Quality of Life

Summary: this study aims to compare oral health-related quality of life and retention between digitally- fabricated temporary flexible rdps and conventionally-fabricated temporary flexible rdps.


Eligibility criteria:
inclusion criteria: * maxillary class iii, modification i partially edentulous patients that enables measuring the retention values intraorally without denture rotation. * fully dentulous or partially edentulous opposing mandibular arch. * patients that require temporary partial dentures for aesthetic reasons or as an interim denture during mouth rehabilitation treatment or after implant placement. * age range (30-55 years). * cooperative patients that are willing to attend all follow-up periods. * patients with healthy attached mucosa of appropriate thickness free from any inflammation. * patients with healthy abutments and healthy periodontium and no more than grade i mobility. exclusion criteria: * patients with parkinson's disease * patients with xerostomia. * patients with a history of allergy to dentures made of resins. * patients with pathological changes of residual ridges as recurrent or persistent ulcers, osteomyelitis and infections. * patients with large irregular bony exostosis. * patients with medical or psychological conditions as physical disability or mental retardation that hinder cooperation in the follow up visits and answering the questionnaires.
oral health literacy tailored communication

Conditions: Periodontal Diseases; Dental Plaque; Dental Calculus; Sialorrhea; Streptococcal Infections; Lactobacillus Infection

Summary: the purpose of this study to investigate attitude, oral health literacy and psychological factors in order to evaluate if these factors are important for oral health in adults. the hypotheses are: * multiple interactive demographic, and social and psychological factors contribute to the level of attitude and oral health literacy. * there is an association between the level of oral health literacy and oral health status * a structured intervention based on oral health literacy can change the attitude and improve the oral health status. * background knowledge has influence on attitude and oral health literacy * individuals with positive attitude towards dental health and dentist are attentive towards their oral health.

this study will be conducted in two stages. the first stage includes a baseline cross-sectional investigation. oral health literacy level will be assessed by conducting a structured interview. background variables, attitude, socioeconomic factors and psychological factors shall be assessed using self-administered questionnaires. a clinical examination will be conducted including general health information and extended oral health examination. the oral health examination performed includes record of oral hygiene status such as dental caries and periodontal status. an assessment of oral bacteria will also be performed. the second stage will be carried out approximately 6 months after starting with the baseline investigation. at that time a modified version of the questionnaires will be used followed by a shorter clinical examination. the modified questionnaires at the second data collection exclude some background variables. the clinical examination carried out during this time will be on dental plaque and bleeding index and the level of oral bacteria.

Eligibility criteria:
inclusion criteria: * participants \> 20 years of age. * participants who master the norwegian language. * participants who are registered at the university dental clinic (iko). exclusion criteria: * people who do not master the norwegian language. * strongly visually impaired people that have difficulty in reading. * people with a history of heart-attack in the past 6 months. * immune- compromised people and organ- transplanted people. * people with other conditions that might lead to more disadvantages than advantages by participating
evaluating the impact of b vitamin supplementation (soloways™) on homocysteine and ldl-c levels in patients with mthfr, mtr, and mtrr polymorphisms.

Conditions: Hyperhomocysteinemia; Hyperlipoproteinemias

Summary: this randomized, double-blind, placebo-controlled trial will evaluate the impact of methylfolate, pyridoxal-5'-phosphate (p5p), and methylcobalamin supplementation on homocysteine and ldl-c levels in individuals with low to medium cardiac risk and mthfr, mtr, and mtrr gene polymorphisms. the study aims to explore the efficacy of these vitamins in reducing homocysteine levels, a critical risk factor for cardiovascular disease (cvd), while also monitoring ldl-c levels. the findings will offer valuable insights into personalized cvd prevention and management, emphasizing the significance of genetic factors in nutritional therapy.

design: participants with specific genetic polymorphisms and homocysteine levels above 15 µmol/l, without a history of severe cvd or other exclusion criteria, will be enrolled and randomized into two groups: one receiving methylfolate, p5p, and methylcobalamin, and the other a placebo. the study, adhering to ethical standards and informed consent, will involve 54 patients divided equally between the treatment and placebo groups. the primary endpoint will be the percent change in homocysteine levels over six months, with secondary endpoints including changes in ldl-c and other lipid profile components. intervention: participants will receive either the active treatment (l-methylfolate, p5p, and methylcobalamin) or a placebo, with both groups taking two capsules daily for 180 days. fasting measurements of lipid profiles and homocysteine levels will be conducted at the start, midpoint, and end of the study.

Eligibility criteria:
inclusion criteria: * age between 40 and 75. * homocysteine levels greater than 15 µmol/l and ldl-c level between 70 and 190 mg/dl, confirmed in at least two sequential checks conducted within the last six months prior to signing the consent form. * presence of at least one minor allele in any of the following genetic polymorphisms: rs1801133 (mthfr c677t), rs1801131 (mthfr a1298c), rs1805087 (mtr a2756g), and rs1801394 (mtrr a66g). exclusion criteria: * personal history of cardiovascular disease or high risk (≥ 20%). * triglycerides (tg) ≥ 400 mg/dl. * obesity (body mass index \> 32 kg/m\^2). * assumption of lipid-lowering drugs or supplements affecting lipid metabolism within the last three months. * use of medications or supplements known to affect homocysteine levels, such as b-vitamins and certain antihypertensives, within the last three months. * diabetes mellitus. * known severe or uncontrolled thyroid, liver, renal, or muscle diseases.

Keywords: methylfolate homocysteine genetic polymorphisms (mthfr, mtr, mtrr) cardiovascular risk methylcobalamin ldl-c cholesterol low-density lipoprotein
is a tha stem in varus a risk factor of long-term mechanical complication

Conditions: Hip Arthritis

Summary: the objective of this study is to compare the long-term survival as well as the functional and radiographic results of the rods in the alignment of the varus to the stems in the neutral alignment by comparing 2 groups of implanted total hip arthroplasty. 1 group of stems implanted in varus position. 1 group of stems implanted in neutral position

abstract: introduction: femoral stem positioning in the frontal plane has always been considered a fundamental criterion for implant survival and for functional and radiographic outcomes in total hip arthroplasty (tha). the impact of implanting cementless femoral stems in varus alignment on long-term mechanical complications remains poorly defined in the literature. the aim of our study is to compare long-term survivorship as well as functional and radiographic outcomes of stems in varus alignment to stems in neutral alignment. patients and methods: this single center, multi-surgeon, retrospective case-control study will compare a group of 105 tha patients with varus stem alignment (vs) to a control group of 105 tha patients with neutral stem alignment (ns), operated in brest center between january 2007 and december 2012. the primary outcome measure is implant survival. secondary outcomes include functional outcomes: hhs, pma, thigh pain, dislocation and hip rom; and radiographic outcomes: radiolucency, agora roentgenography assessment (ara) score, osseointegration, heterotopic ossification, subsidence and stress shielding.

Eligibility criteria:
inclusion criteria: * pth rod implanted in varus, * having x-rays and clinical data in their file * within a period of less than 6 months * no opposition exclusion criteria: * pth in a context of fracture of the femoral neck * pth 2nd intention * lost to sight * patients who died within 6 months * refusal to participate
effect of gnrh agonist vs gnrh antagonist on ivf/icsi outcomes.

Conditions: In Vitro Fertilization; Intracytoplasmic Sperm Injection; Infertility

Summary: the aim of this prospective, non-randomised, open-label, clinical trial is to compare the effects of two pituitary suppression regimens; gnrh agonist-long protocol and gnrh antagonist-flexible protocol on clinical and embryological ivf/icsi outcomes, and on the follicular fluid levels of placental growth factor (plgf); which is known for his pivotal role in the regulation of ovulation, embryo development, and implantation.


Eligibility criteria:
inclusion criteria: * women undergoing ivf/icsi. * age: 18-39 years. * both ovaries present. exclusion criteria: * age ≥ 40 years. * history of three or more previous ivf failures. * patients with hormonal disorders like hyperprolactinemia, thyroid disorders. * patients with polycystic ovary syndrome. * patients who previously undergo unilateral oophorectomy. * patients with chronic diseases: diabetes mellitus, cardiovascular diseases, liver diseases, kidney diseases. * patients with diseases may affect ivf outcomes: endometriosis, uterine fibroids, hydrosalpinx, adenomyosis, autoimmune diseases, * cancer.

Keywords: gnrh agonist gnrh antagonist assisted reproduction technique in vitro fertilization intracytoplasmic sperm injection placental growth factor
preoperative diagnostic tests for pulmonary risk assessment in copd

Conditions: Lung Diseases, Obstructive; Postoperative Complications

Summary: this prospective study intends to investigate the incidence of postoperative pulmonary complications (ppc) or in-hospital mortality in patients with copd or at risk for copd undergoing high-risk noncardiac major surgery and to identify relevant risk factors. this study aims to quantify and compare the diagnostic performance of preoperative functional tests, exercise capacity, clinical assessment tests and predictive scoring systems to predict ppc or in-hospital mortality in these patients.

copd is associated with high perioperative morbidity and mortality and ppc frequently occur in these patients. however, concepts for preoperative pulmonary risk assessment and the predictive value of routine preoperative exercise capacity, clinical assessment and pulmonary function tests are still poorly characterized. objectives: * to determine the incidence of the composite end point of ppc or all cause in-hospital mortality in patients with confirmed copd (spirometry) and patients with clinical risk factors in whom spirometry disproved copd. * to determine the predictive value of exercise capacity, clinical assessment tests, pulmonary function tests and predictive scoring systems to predict the composite end point in these patients. * to identify relevant risk factors and predictors associated with the composite end point. methodology: prospective single-centre observational study all patients receive a structured preoperative pulmonary risk assessment with: 1. standardized clinical questionnaire 2. copd assessment test (cat™) 3. exercise capacity (symptom-limited stair climbing) 4. spirometry 5. capillary blood gas analysis postoperative follow-up is planned between the 2nd and 5th day after extubation.

Eligibility criteria:
inclusion criteria: * 18 years and older * high-risk noncardiac major surgery with an anticipated operation time ≥ 120 minutes and/or planned postoperative intensive care unit admission * typical clinical signs for copd (dyspnea, chronic cough, chronic sputum production, exposure to risk factors) * confirmed copd (medical history) or clinical risk factors for copd * positive copd assessment test (cat™) exclusion criteria: * \< 18 years * pregnancy * lack of cooperation * inability to provide functional tests like spirometry or stairclimbing

Keywords: spirometry exercise test blood gas analysis respiratory function tests diagnostic techniques, respiratory system surgical procedures, operative
prospective elimination of distal coronary sinus-left atrial connections for atrial fibrillation ablation trial

Conditions: Atrial Fibrillation; Arrhythmias, Cardiac

Summary: atrial fibrillation (af) is the most common cardiac arrhythmia affecting millions of people in the us and around the world. over the last 20 years, catheter based af ablation has been widely adopted offering improved symptom control for many patients worldwide. however, long-term success rates remain suboptimal. prior work indicates that distal connections between coronary sinus musculature and the left atrium exist and provide a substrate for single or multiple reentry beats as a trigger for atrial fibrillation. in this trial, the investigators will examine the efficacy of elimination of distal connection(s) between coronary sinus and left atrial musculature for suppression of recurrent atrial arrhythmias.

atrial fibrillation (af) is the most common cardiac arrhythmia affecting millions of people in the us and around the world. over the last 20 years, catheter based af ablation has been widely adopted. however, long-term success rates fhave been reported to be as low as 50% and 20% for paroxysmal and persistent af, respectively. to achieve permanent arrhythmia suppression, repeated ablation procedures are often needed. prior work indicates that distal connections between coronary sinus musculature and the left atrium provide a substrate for single or multiple reentry beats as a trigger for atrial fibrillation. in this prospective randomized trial the investigators will define the efficacy of elimination of distal connections between coronary sinus and left atrial musculature for suppression of recurrent atrial arrhythmias. patients will be randomly assigned to standard of care ablation (pulmonary vein isolation and non pulmonary vein trigger ablations) alone, or standard of care ablation augmented by distal coronary sinus to left atrial connection elimination.

Eligibility criteria:
inclusion criteria: * patients with paroxysmal or persistent atrial fibrillation; and undergoing first af ablation; and age ≥ 18 years. exclusion criteria: * previous left atrial ablation; women currently pregnant; mental or physical inability to take part in the study; known terminally ill patients.

Keywords: atrial fibrillation coronary sinus-left atrium connection ablation
a study to evaluate the efficacy and safety study of povorcitinib in participants with inadequately controlled moderate to severe asthma

Conditions: Moderate to Severe Asthma

Summary: the study is being conducted to evaluate the effect of 3 dosing regimens of povorcitinib on pulmonary function


Eligibility criteria:
inclusion criteria: * physician-diagnosed asthma requiring treatment with medium- to high-dose ics-laba for at least 12 months prior to screening. * pre-bd fev1 \< 80% predicted according to central over read value at visit 2. * documented historical post-bd reversibility of fev1 ≥ 12% and ≥ 200 ml in fev1. * at least 2 documented asthma exacerbations (requiring treatment with systemic cs, hospitalization, or emergency department visit) within 12 months prior to screening but not within the past 4 weeks prior to screening * acq-6 ≥ 1.5 at screening. exclusion criteria: * maintenance use of asthma controllers other than ics-laba. * have undergone bronchial thermoplasty. * current smokers or participants with a smoking history of ≥ 10 pack-years and participants using vaping products, including electronic cigarettes. * women who are pregnant (or who are considering pregnancy) or breastfeeding. * current conditions or history of other diseases, as follows: * clinically important pulmonary disease other than asthma ,thrombocytopenia, coagulopathy, or platelet dysfunction. * venous and arterial thrombosis, deep vein thrombosis, pulmonary embolism, moderate to severe heart failure (nyha class iii or iv), cerebrovascular accident, myocardial infarction, coronary stenting, or cabg surgery. * diagnosis of other significant cardiovascular diseases, including but not limited to angina, peripheral arterial disease, or uncontrolled arrhythmias such as atrial fibrillation, supraventricular tachycardia, ventricular tachycardia, and forms of carditis. * recipient of an organ transplant that requires continued immunosuppression. * immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, wiskott-aldrich syndrome). * any malignancies or history of malignancies. * chronic or recurrent infectious disease. * receipt of any biologic drugs used for asthma \< 12 weeks or 5 half-lives (if known), whichever is longer, prior to screening

Keywords: asthma moderate to severe incb54707 povorcitinib ics-laba
vision care intervention for lower grade school children in taiwan

Conditions: Myopia; Outdoor Activity; Policy of Recess Outside Classroom

Summary: the purpose of this study is making use of school policy- recess outside classroom (roc7-11) for increasing the time spent outdoor during recess and encouraging children spent time outdoor up to 11 hours in each week to investigate the vision change, myopia onset and progression in these schoolchildren.


Eligibility criteria:
inclusion criteria: all the students in grade 1 exclusion criteria: no

Keywords: myopia outdoor activity recess outside classroom