Kornimate/medical-research-clean huggingface dataset:
maternal tdf and ftc to reduce nnrti resistance mutations after intrapartum nvp

Conditions: HIV; Pregnancy

Summary: the purpose of this study is to determine whether the addition of tenofovir (tdf) and emtricitabine (ftc)to a standard pmtct regimen containing single-dose nevirapine (nvp) can reduce the development of post-ingestion hiv resistance to non-nucleoside reverse transcriptase inhibitors (nnrtis).

single-dose intrapartum and neonatal nevirapine (nvp), either alone or in combination with short course zidovudine (zdv) is in widespread use to prevent mother-to-child hiv transmission throughout the developing world. though the public health benefits cannot be overstated, widespread use of nvp in this fashion may come at a cost. non-nucleoside reverse transcriptase inhibitor (nnrti) resistance mutations are induced in at least 20% and probably a larger proportion of women exposed to nvp in this fashion. addition of short-course zdv does not appear to mitigate this effect substantially. the full implications of these nvp resistance mutations are yet unknown, though there is concern that they may result in reduced efficacy of the nvp or other nnrtis in long-term, therapeutic regimens. we are conducting a clinical trial of tenofovir (tdf) and emtricitabine (ftc), marketed as a fixed dose combination, truvada ™, to reduce nnrti-resistance post-delivery in the setting of nvp with or without zdv for pmtct. tdf and ftc are both category b drugs and are approved for use in pregnancy. they have several characteristics that make them ideal candidate drugs for use in conjunction with nvp, including long intracellular half-lives and established safety profile among adults for hiv treatment. women will be enrolled between 28 and 38 weeks of gestation. as part of normal pmtct services, they may choose nvp-boosted zdv or single dose nvp for pmtct; we anticipate that most (\~80%) will choose the former. at arrival for delivery, they will be randomized to receive either the two study drugs (intervention) or no drug (control). a total of 400 women will be randomized, and followed, along with their infants, for 6 months.

Eligibility criteria:
inclusion criteria: * serologically confirmed hiv infection; * gestational age of 28 to 38 weeks; * previous selection of a nvp-based pmtct regimen (with or without zdv) * willingness to participate in a randomized trial; * willingness to follow up in a postpartum visit schedule; * willingness to allow her infant to participate in this trial; exclusion criteria: * use of antiretroviral medications before this pregnancy, even in a single dose. * current use of antiretroviral medications for treatment of advanced hiv disease and/or aids * illness or complication of pregnancy likely to warrant transfer to the university teaching hospital (uth), known at time of randomization; * known or suspected allergy to nvp or other benzodiazepine medications; * history of known liver disease. * hemoglobin level of 7.9 g/dl or less

Keywords: hiv pregnancy mother-to-child transmission of hiv drug resistance nevirapine resistance nnrti resistance
bilberry-containing capsules for dry eye mitigation

Conditions: Dry Eye

Summary: this study investigates whether the oral intake of a bilberry capsule product may relieve dry eye symptoms. participants will be aged between 20 - 65 years of age, with confirmed diagnosis of dry eye status. the participants will be assessed for several parameters and asked to take 4 bilberry capsules per day for 30 days. the parameters will include ocular surface health, tear volume, tear quality, intraocular pressure, and tear compositions. after the 30 days are completed, the participants will be assessed again for the same parameters.

this investigation is a randomized, double-blind study. subjects with confirmed diagnosis of dry eye are randomly assigned to group a or group b, and asked to orally intake 4 capsules of either bilberry product or placebo per day.the group a will have bilberry product for 30 days, have a 20-day washout period, and then have placebo for another 30 days. the group b will have placebo for 30 days, have a 20-day washout period, and then have bilberry product for another 30 days. all participants will be assessed for parameters, including intraocular pressure, ocular surface health, tear film breakup time (tbut), tear volume (schirmer's test), tear composition (na+, k+, cl- ions), tear osmolarity, ocular surface impression cytology, and ocular surface disease index (osdi). the assessments are conducted immediately before the first 30-day and immediately after the second 30-day oral intake period. the parameters are used to compare and evaluate whether the bilberry product can relieve dry eye symptoms.

Eligibility criteria:
inclusion criteria: * aged between 20 and 65 years * with schirmer's test results between 5 - 10 mm or tear film break up time less than 10 seconds * ocular surface disease index more than 25 exclusion criteria: * evident ocular diseases such as cornea disease, cataract, vitreous degeneration, glaucoma, and retinopathy. * diabetes * hypertension * or other chronic diseases or belong to vulnerable groups(pregnancy woman, prisoner, ethical minorities, economic or educationally disadvantaged subjects, disabled individuals such as those at terminal stage of tumorigenesis, blindness, terminal ill individuals)

Keywords: bilberry anthocyanin dry eye eye sore eye strain
interest of a hybrid connected watch for cardiac rhythm monitoring in post-operative cardiac surgery

Conditions: Atrial Fibrillation

Summary: the objective of this single-center pilot study is, with the help of a connected watch, to show the absence of recurrence or maintenance of sinus rhythm in patients with a post operative atrial fibrillation (poaf) and to help treating cardiologists in the care of these patients.


Eligibility criteria:
inclusion criteria: * major with an indication for conventional cardiac surgery with de novo postoperative af onset. * agreeing to participate in the study and having signed an informed consent. * agreeing to undergo 12 months of postoperative monitoring. exclusion criteria: * patient with pre-operative af * patient who does not have a smartphone compatible with the connected watch. * patient unable to perform an ecg measurement independently. * patient with a physical constraint to the measurement (arteriovenous fistula...) * minors * pregnant or breast-feeding women * adults under guardianship, under curatorship * patients whose life expectancy is less than 1 year * patients participating in another therapeutic trial likely to impact the evaluation criteria of the monhycard study * contraindication to long-term anticoagulants * patients implanted with a mechanical valve prosthesis pre-operatively or after surgery

Keywords: post operative atrial fibrillation connected watch
covid-19 child health investigation of latent disease in hamburg

Conditions: SARS-CoV-2; Covid19

Summary: the study measures infection rates and the presence of antibodies for sars-cov-2 (covid-19) among in- and outpatients of all pediatric hospitals, as well as volunteers aged 0 to 18 years in hamburg, germany. participants with a positive nasopharyngeal swab pcr or a positive antibody test enter the follow-up phase of 6 months. the follow up includes a pcr and antibody testing of all household contacts at 0, 3 and 6 months, as well as laboratory testing of children to identify immunological, metabolic and genetic risk factors for infection and clinical outcome.

the study is divided into a screening phase and a follow-up phase. in the screening phase, an obligatory polymerase chain reaction (pcr) in the nasopharyngeal swab and an optional serum antibody testing are carried out for severe acute respiratory syndrome coronavirus 2 (sars-cov-2). an obligatory standardized questionnaire is used to evaluate symptoms and contacts, medical history and underlying conditions and the psychological effects of the coronavirus disease 2019 (covid-19) pandemic, as well as its effects on individual access to medical care. children with a positive nasopharyngeal swab or antibody test, as well as their household contacts aged 0 to 18 years enter the follow-up phase. during the follow-up phase, blood and urine samples are taken from children for immunological analysis, hla typing and untargeted metabolomics, enabling a broad analysis of the adaptive and innate immune response to sars-cov-2, as well as metabolic and genetic risk factors for infection and disease compared to age and sex-matched healthy controls. furthermore, a repeated swab and antibody testing at 0, 3 and 6 months for children and adult household contacts is carried out to analyse household transmission of sars-cov-2 in children and adults and the persistence of antibodies.

Eligibility criteria:
inclusion criteria: * children or teenagers aged 0-18 years * patient in one of the participating centers or volunteer in the central c19.child study clinic * informed consent from parents or guardians. * informed consent from children \>7 years (unless not capable) exclusion criteria: * prematurity \<37 weeks of gestation * informed consent of parents and guardians not possible in spoken word or otherwise * informed consent not given

Keywords: pediatric children observational antibody pcr immunology metabolomics household
a retrospective cohort study of mavacamten patient support program in canada

Conditions: Hypertrophic Cardiomyopathy

Summary: this real-world study will describe the demographic and clinical characteristics and mavacamten treatment of adult patients with obstructive hypertrophic cardiomyopathy who participated in the bristol-myers squibb (bms)-sponsored camzyos patient support program in canada.


Eligibility criteria:
inclusion criteria: * participants ≥18 years of age. * participants who have initiated mavacamten as part of routine clinical care, through the bms-sponsored camzyos patient support program for the treatment of symptomatic obstructive hypertrophic cardiomyopathy. * participants who consented to the use of their de-identified data, generated from information collected in the course of the program. exclusion criteria: • there are no exclusion criteria.

Keywords: hypertrophic cardiomyopathy
cycling dual-task in parkinson's disease

Conditions: Parkinson Disease

Summary: taking into account the process of functional and cognitive evolution that patients with parkinson's disease experience throughout the evolution of the pathology, the objective of this study is to evaluate the effect of a dual-task program combining cognitive tasks and forced cycling on the functional and cognitive capacity of these patients.


Eligibility criteria:
inclusion criteria: * parkinson disease * hoehn and yahr 1 and 2 exclusion criteria: * hoehn and yahr \>2
brain network analysis of anesthesia characteristics in patients with pdoc based on psg

Conditions: Disorders of Consciousness

Summary: the goal of this prospective, exploratory and observational study is to learn about in healthy volunteers and patients with prolonged disorders of consciousness(pdoc). the main questions it aims to answer are: 1. observe the similarities and differences of polysomnography between pdoc patients and healthy volunteers, and analyze the characteristic brain network changes based on polysomnography 2. to observe the similarities and differences of polysomnography in pdoc patients before and after insertion of spinal cord electric stimulator under general anesthesia,and analyze the changes of anesthesia characteristic brain network in patients with consciousness disorders based on polysomnography. 3. to observe the similarities and differences of polysomnography in pdoc patients before and after spinal cord stimulation,and analyze the characteristic changes of brain network after spinal cord stimulation. we will record the 8h polysomnography of healthy volunteers,record the polysomnography of doc patients before and 24 hours after operation;and record the 24h polysomnography of patients with spinal cord electric stimulator.


Eligibility criteria:
inclusion criteria: * inclusion criteria of health volunteer group: 1. aged 18-65, native chinese 2. no history of sleep apnea 3. no history of insomnia 4. volunteer to participate in this study and obtain informed consent. * inclusion criteria of pdoc group: 1. aged 18-65, native chinese 2. pdoc after acquired brain injury 3. the spinal electric stimulator was implanted under general anesthesia 4. obtain informed consent. * exclusion criteria: 1. healthy volunteers took hypnotic drugs 72 hours before the study 2. continuous sedation treatment was carried out within 72 hours before the study 3. the integrity of brain structures such as open head injury and brain parenchyma resection 4. intracranial compliance decreased due to hydrocephalus 5. airway stenosis and severe ventilation or ventilation dysfunction caused by various reasons 6. known or suspected to have serious heart, lung and kidney dysfunction 7. allergic history of sedative drugs 8. combined with other mental or nervous system diseases 9. other reasons are not suitable for this study.
liver cauterization increases the postoperative pain after laparoscopic cholecystectomy

Conditions: Laparoscopic Cholecystectomy; Postoperative Pain

Summary: laparoscopic cholecystectomy is a common accepted surgical operation with lower morbidity all over the world for gallstone. although it has low morbidity, postoperative pain is challenging situation like every other operation.

postoperative pain after laparoscopic cholecystectomy has a three component: parietal, visceral and referring (shoulder) pain. although intensities of them can be various, all of them affects the total pain together. unintentional liver cauterization during laparoscopic cholecystectomy is unwanted, but sometimes unavoidable complication/process. however its effect on postoperative pain is not studied with detail in literature.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists (asa) physical status i-ii * presumptive diagnosis of benign gallbladder disease exclusion criteria: * the patients with concurrent chronic disease like osteoporosis, and liver, pulmonary or renal disease, malignant disease
partners for pain & wellbeing equity: a randomized trial of community supported complementary and integrative health self-management for back pain

Conditions: Neck Pain; Low Back Pain; Chronic Pain

Summary: the focus of this project is on developing and optimizing community-based programs for the self-management of back or neck pain for individuals from populations that experience health disparities (bp-pehd). community-engaged research approach will be used to conduct quality improvement activities that involves gathering feedback from multiple stakeholders to inform development of the study interventions and materials which will be followed by a randomized pilot study to evaluate feasibility. supported by the national center for complementary and integrative health through the national institutes of health's heal initiative (https://heal.nih.gov/)"


Eligibility criteria:
inclusion criteria: * provide a signed and dated informed consent form * state willingness to comply with all study procedures outlined in the consent form * be 18 years of age or older * have self-reported chronic back pain (defined as pain in the low or mid back, or neck pain) which has lasted for 3 months or longer * have a score of 3 or higher on the self-reported pain, enjoyment of life and general activity (peg) scale (0 to 10) * be a member of one or more of the following nih-designated health disparity populations: american indian/alaska native, asian, black/african american, hispanic/latino, native hawaiian/pacific islanders, socioeconomically disadvantaged (annual household income less than $50,000) exclusion criteria: * hospitalization for severe mental illness in past six months because the mindfulness and behavioral mind-body practices (e.g., meditation, progressive muscle relaxation, etc.) in the experimental intervention may aggravate symptoms of severe mental illness * active psychotic symptoms, suicidal ideation, or manic episodes in the past three months for the same reasons noted in #1 * self-reported cancer with active treatment involving radiation or chemotherapy due to the potential for complications of their back or neck pain and impact on health outcomes * dementia - mini mental state exam score of 23 or lower for those with suspicion of cognitive impairment due to safety risks (e.g., not being able to follow directions for safe physical exercise) * self-reported pregnancy due to the fact that back pain is often associated with pregnancy and differs from non-pregnancy related back pain and thus might have different impacts on health outcomes * children under the age of 18
a bleeding-model clinical study

Conditions: Gingivitis

Summary: the objective of the study is to evaluate the gingivitis control benefit of an established stannous fluoride containing toothpaste relative to a negative control dentifrice.


Eligibility criteria:
inclusion criteria: * be at least 18 years of age; * provide written informed consent prior to participation and be given a signed copy of the informed consent form; * be in general good health as determined by the investigator based on a review of the health history/update for participation in the trial; * have at least 20 gradable teeth; * have established gingivitis with ≥10 % bleeding sites; * agree to return for scheduled visits and follow the study procedures; * agree to refrain from use of any non-study oral hygiene products for the duration of the study; * agree to delay any elective dentistry, including dental prophylaxis, until the completion of the study. exclusion criteria: * having taken medications (antibiotic, anti-inflammatory, or anti-coagulant) which could alter gingival bleeding within 4 weeks of the baseline visit; * having any oral conditions that could interfere with study compliance and/or examination procedures, such as widespread caries, soft or hard tissue tumor of the oral cavity, or advanced periodontal disease; * having known hypersensitivity to the test products; * having removable oral appliances; * having fixed facial or lingual orthodontic appliances; * self-reported pregnancy or lactation; * having any diseases or condition that might interfere with the safe participation in the study; * having an inability to undergo study procedures.
a study of mabthera (rituximab) in patients with rheumatoid arthritis who have failed on one prior anti-tnf therapy (reset)

Conditions: Rheumatoid Arthritis

Summary: this study will evaluate the safety and effectiveness of mabthera (rituximab) in patients with active rheumatoid arthritis who are receiving methotrexate, and who have a previous or current inadequate response to one prior anti-tnf therapy. all patients will receive mabthera 1000 mg as an intravenous infusion on days 1 and 15. after the initial study phase of 24 weeks, eligible patients may receive one re-treatment with mabthera. the anticipated time on study treatment is 48 weeks.


Eligibility criteria:
inclusion criteria: * adult patients, 18-80 years of age * moderate to severe active rheumatoid arthritis * inadequate response to a single previous or current treatment with an anti-tnf agent * methotrexate for at least 12 weeks, at a stable dose over the past 4 weeks exclusion criteria: * previous treatment with mabthera * use of an anti-tnf agent within past 8 weeks (4 in the case of etanercept) * concurrent treatment with any disease modifying anti-rheumatic drug (dmard) other than methotrexate * active infection, or history of serious or chronic infection
exercise dose and nonalcoholic fatty liver disease

Conditions: Non-alcoholic Fatty Liver Disease (NAFLD)

Summary: the purpose of this research is to provide a better understanding of how exercise (walking) affects non-alcoholic fatty liver disease (nafld) in overweight people. nafld, which is common in obese people, occurs when the liver has too much fat.

non-alcoholic fatty liver disease (nafld) affects about 33% of adults in the united states. the prevalence of nafld is four to five times higher in obese than lean persons and is associated with insulin resistance and the metabolic syndrome. decreasing calorie intake and increasing physical activity has been recommended as primary therapy for nafld, but the independent effect of aerobic exercise is unknown. the current exercise guidelines for disease prevention and weight management range from 150 min/wk, recommended by the centers for disease control and the american college of sports medicine, to 300 min/wk, recommended by the institute of medicine. however, it is not known whether aerobic exercise alone can improve nafld, and which recommended dose of exercise might have the most beneficial effects. the purpose of this proposal is to determine the effect of moderate intensity endurance exercise on: 1) hepatic fat content; 2) hepatic lipoprotein kinetics; and 3) plasma inflammatory markers. we hypothesize that aerobic exercise will decrease hepatic fat content, improve vldl kinetics, and decrease inflammation in a dose-dependent fashion. the results from this study will help determine exercise guidelines for obese patients with nafld, and lay the groundwork for future studies evaluating the effects of exercise on metabolic diseases associated with obesity. this proposal involves conducting a randomized controlled trial that will randomize obese subjects with nafld (\> 10% hepatic fat content) to one of two groups: group 1 (control, no exercise) and group 2 (moderate intensity aerobic exercise- 150 min/wk to 300 min/wk of supervised exercise performed at 45-55% of o2 max).

Eligibility criteria:
inclusion criteria: * age 18-65 with nonalcoholic fatty liver disease as determined by mrs exclusion criteria: * medical history * diabetes * heart disease * asthma/lung disease * injury that prevents exercise * social history * drinking * more than one drink per day * binge drinking on the weekends (more than 3 or 4 drinks per weekend day) * smoking * it's ok if they were a previous smoker, but they need to have quit more than 6 months ago * exercise * they must exercise less than one hour per week * medications: must be on stable regimen of any medication for at least 3 months * beta-blockers * lipid/cholesterol lowering medications: * oral hypoglycemics (anti-diabetes medications - some like metformin are indicated for pre-diabetes) * hormone replacement therapy * if the woman is pre-menopausal, it is ok if she is on birth control as long as she has been on it over 3 months * weight history * weight \<300 lbs * bmi 30 to 45 * weight stable - \<10lbs weight loss or gain in the last 3 months

Keywords: nafld obesity metabolic syndrome nonalcoholic fatty liver disease