Kornimate/medical-research-clean huggingface dataset:
a study to investigate the efficacy of fenebrutinib in relapsing multiple sclerosis (rms)

Conditions: Relapsing Multiple Sclerosis

Summary: this is a study evaluating the effect of fenebrutinib on brain magnetic resonance imaging (mri) in participants with rms. the safety and pharmacokinetics of fenebrutinib will also be evaluated. participants will be randomized to receive either fenebrutinib or placebo. this study consists of two parts: double-blind treatment (dbt) phase and an optional open-label extension (ole) phase.


Eligibility criteria:
inclusion criteria: * a diagnosis of rms in accordance with the revised 2017 mcdonald criteria. * expanded disability status scale (edss) score of 0 - 5.5 at screening. * for female participants of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating eggs. * for male participants: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive measures, and refrain from donating sperm. exclusion criteria: * disease duration of \> 10 years from the onset of symptoms and an edss score at screening \< 2.0. * female participants who are pregnant or breastfeeding, or intending to become pregnant. * male participants who intend to father a child during the study. * a diagnosis of primary progressive multiple sclerosis (ppms) or non-active secondary progressive multiple sclerosis (spms). * any known or suspected active infection at screening, including but not limited to a positive screening tests for hepatitis b and c, an active or latent or inadequately treated infection with tuberculosis (tb), a confirmed or suspected progressive multifocal leukoencephalopathy (pml). * history of cancer including hematologic malignancy and solid tumors within 10 years of screening. * presence of other neurological disorders that could interfere with the diagnosis of ms or with the assessments of safety or efficacy during the study. * clinically significant cardiovascular, psychiatric, pulmonary, renal, hepatic, endocrine, metabolic or gastrointestinal disease. * any concomitant disease that may require chronic treatment with systemic corticosteroids or immunosuppressants during the course of the study. * history of alcohol or other drug abuse within 12 months prior to screening. * history of or currently active primary or secondary (non-drug-related) immunodeficiency, including known history of hiv infection. * inability to complete an mri scan. * adrenocorticotropic hormone or systemic corticosteroid therapy within 4 weeks prior to screening. * receipt of a live-attenuated vaccine within 6 weeks prior to randomization. * any previous treatment with immunomodulatory or immunosuppressive medication without an appropriate washout period.
lanthanum carbonate (fosrenol®) to reduce oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis

Conditions: Secondary Hyperoxaluria; Nephrolithiasis

Summary: this study investigates the efficacy and the safety of lanthanum carbonate for the reduction of urinary oxalate excretion in patients with secondary hyperoxaluria and nephrolithiasis.

nephrolithiasis/urolithiasis is a prevalent (overall lifetime risk up to 13% in western countries) and highly recurrent disease. secondary hyperoxaluria is a key risk factor for the development of calcium oxalate stones, the most frequent stone type. currently used therapeutic options in secondary hyperoxaluria have limited efficacy. recent findings in vitro and in a rat model, provided evidence that lanthanum carbonate is an effective oxalate binder. the objective of this study is to investigate whether treatment with lanthanum carbonate reduces urinary oxalate excretion in human subjects with secondary hyperoxaluria and nephrolithiasis. by treating the patients with two different doses of lanthanum carbonate during two 14-day treatment periods, a dose-response will be evaluated.

Eligibility criteria:
inclusion criteria: * able to give written informed consenct * hyperoxaluria (defined as urinary oxalate \> 45 mg/24 hours), demonstrated on 24-hour urine collection within 18 months prior to baseline visit * history of nephrolithiasis egfr \> 60 ml/min/1.73m² (ckd-epi formula) exclusion criteria: * primary hyperoxaluria, diagnosed by genetic testing * known allergy to lanthanum carbonate * hypophosphatemia (defined as serum phosphorus \< 0.81 mmol/l) * severe known liver insufficiency of biliary obstruction * rectocolitis ulcerohaemorraghica, crohn's disease, bowel obstruction, stomach/duodenal ulceration * glucose/galactose malabsorption * severe diarrhea or other gastrointestinal disorder, which might interfere with the ability to absorb oral medication * pregnancy or breast-feeding * female participant of childbearing potential unwilling to take efficient contraceptive measures for the duration of the study * female participant without negative serum or urine pregnancy test * psychological illness or condition, interfering with the patient's compliance or ability to understand the requirements of the study * currently participating in another clinical trial

Keywords: nephrolithiasis urolithiasis secondary hyperoxaluria hyperoxaluria lanthanum carbonate phosphate binder
alcohol versus chlorhexidine with and without water

Conditions: Infection

Summary: currently at nyu institutions, providine-iodine and chlorhexidine medicated soaps are available as hand disinfection options. the purpose of this study is to determine the relative efficacy of traditional hand scrubs with chlorhexidine with or without rinsing with water after scrubbing is complete versus dry hand rubs with alcohol.

no current recommendations exist advocating the use of providine-iodine or chlorhexidine. providine-iodine is safe and effective at reducing skin colonization with gram positive and negative bacteria, mycobacterium tuberculosis, fungi and viruses. chlorhexidine similarly disrupts cellular membranes. it is bacteriocidal and bacteriostatic and has immediate and more lasting effect than iodine because it can bind to the stratum corneum of the skin and is effective against gram positive and negative organisms, lipophilic viruses and yeasts. all subjects who are employees of the nyu hospital for joint diseases and have experience with surgical hand disinfection will be asked to enroll. subjects will be randomized into one of three study arms using an online randomizer: (1) the standard chlorhexidine with water rinse, (2) chlorhexidine without water rinse(experimental), and (3) standard chlorhexidine followed by sterillium hand rub. after hand disinfection protocol has been completed, each subject will have each hand cultured three times using a cotton swab culture stick and sent to the microbiology lab for processing

Eligibility criteria:
inclusion criteria: * orthopedic resident or surgical employee of ny u * over 21 years of age * procedural knowledge of correct aseptic scrub technique exclusion criteria: * no surgical experience * under 21 years of age * refusal to consent

Keywords: chlorhexidine sterility sterile hands
the relationship between the frequency of intraoperative hypothermia and fragility scores

Conditions: Hypothermia; Anesthesia; Fragility

Summary: the goal of this observational study is to compare frequency of intraoperative hypothermia between fragilitly groups of eldery patients who underwent orthopedic surgical procedures. it aims to answer those questions: * i̇s there any difference between fragility groups in terms of hypothermia frequency during orthopedic surgical procedures? * are there any other factors that influence the frequency of hypothermia such as age, body mass index, room temperature etc. ? participants body temperature before anestesia application,and before surgery had started was measured and measurament was done during whole procedure. measuraments had been done by tympanic thermometer.


Eligibility criteria:
inclusion criteria: * elective orthopedic surgery candidates * 65 years old or older exclusion criteria: * emergency surgery * patiens who required multiple (2 or more) blood component transfusions * neurologic disorders * tyroid dysfunction * patiens who are already hypothermic before surgery
niacin and endothelial function in early ckd

Conditions: Chronic Kidney Disease

Summary: the purpose of this study is to obtain information on whether raising levels of hdl-cholesterol (the "good" cholesterol) can improve how blood vessels work in kidney disease. this may help us understand the causes leading to high rates of heart disease in kidney disease and also ways to reduce this risk.


Eligibility criteria:
inclusion criteria: * diagnosis of ckd stage 2 (gfr \>60 and microalbuminuria/proteinuria) and stage 3-4 (gfr 15-30) * hdl-cholesterol \<50 for men and \<55 for women * if taking a statin, stable dose for past one month * glucose \<200 mg/dl and hba1c \<9% * transplant recipients who are in stage 2-3 ckd; 1-year post transplant; and have had no rejection episodes in the 6-months prior to study entry exclusion criteria: * hospitalization within prior 3 months * any of the following conditions: * uncontrolled peptic ulcer disease * active liver disease or abnormal sgot/sgpt * history of adverse reaction to niacin * contra-indication to aspirin * concurrent fibrate therapy * history of gout * serum phosphorus levels below 2.7mg/dl * nursing * pregnancy

Keywords: chronic kidney disease niacin hdl endothelial function
parenting mindfully study ii

Conditions: Adolescent Substance Use; Adolescent Psychological Symptoms; Parent Stress; Parenting

Summary: this study will conduct a large randomized controlled trial to test effects of a parenting mindfully (pm) intervention versus a parent education (pe) intervention for highly stressed parents of adolescents.

parents of early adolescents who report experiencing stress will be randomly assigned to receive the 8 week pm or pe intervention. before, during, and after the interventions, and at 6 month, 1 year, and 2 year follow-ups (into middle adolescence), the researchers will collect questionnaire, interview, and biological measures of parent stress, parenting, and adolescent substance use and psychological symptoms. at pre- and post-intervention, observed parenting and stress reactivity will be measured in a parent-adolescent interaction task. some mothers will also complete fmri sessions at pre- and post- examining emotion-related neurobiological mechanisms.

Eligibility criteria:
main study inclusion/exclusion criteria: inclusion criteria: 1. family with adolescent between 12-14 years; 2. high stress levels for at least one primary caregiver (referred to as "parents" throughout the application, but not required to be biological parents) on stress screener; 3. adequate english proficiency to complete questionnaires for adolescent and at least one parent (because several of our questionnaires have not been validated for use in other languages) exclusion criteria: 1. diagnosis of intellectual disability for adolescent or psychosis for adolescent; 2. current active suicidality that is untreated for parent or adolescent (we will refer participants with active suicidality for inpatient treatment. they will be eligible to participate in the study once stabilized), 3. current suds that are untreated for parent except tobacco use disorder (because participants must to be able to refrain from substances except nicotine/tobacco during the pait lab session day safely without withdrawal symptoms). we will refer parents with active suds to treatment. they will be eligible to participate in the study once stabilized and in treatment. 4. lifetime sud diagnosis for adolescent because an aim of the study is sud prevention. note: we are recruiting for about 130 of the primary caregiver parents to be eligible in and interested in completing functional magnetic resonance imaging (fmri) scans are pre and post-intervention. if we do not meet this number, we will restrict recruitment to those families with one parent who is interested in and eligible for fmri.
feasibility study - integrated sensor and infusion set. trial iii

Conditions: Type 1 Diabetes; Type 2 Diabetes

Summary: the purpose of this study is to collect performance data on the integrated sensor and infusion set during 3 days of use and demonstrate performance adequacy of the integrated sensor and infusion set with glucose sensing and insulin delivery functionalities. the hypothesis of this study is that having the infusion of insulin in close proximity to the sensor does not interfere with the sensor accuracy. this study focuses on high bolus patients. a high bolus is defined as 12 units or more.


Eligibility criteria:
inclusion criteria: * subject is 21-70 years of age at time of screening (age criteria chosen in order to comply with other studies in the same field of research). * subject has a clinical diagnose of type 1 or type 2 diabetes, as determined by investigator. * subject has one or more established insulin carbohydrate ratio. * subject has one or more established insulin correction ratio. * subject is a high bolus user (\>10 units/meal) for at least one meal a day. * subject is currently using a medtronic insulin pump and has been so for a minimum of 3 months at time of enrollment. * subject has been using insulin for more than one year. * subject is willing to wear two pumps, one sensor, one infusion set and one integrated sensor and infusion set at one time (first night). * subject is willing to perform frequent smbgs during visits 3 and 4. * subject is in good general health without other acute or chronic illnesses. exclusion criteria: * vulnerable population will not be included in the study * subject is pregnant as per urine test or lactating (if female), as self-declared by patient. * subject plans to become pregnant during the course of the study. * subject is unable to tolerate tape adhesive in the area of sensor placement. * subject has any unresolved adverse skin condition in the area of sensor or device placement (e.g. psoriasis, rash, staphylococcus infection). * the subject has complications such as advanced autonomic neuropathy, legal blindness, or symptomatic cardiovascular disease as evidenced by a cardiovascular episode within the last six months. * the subject has any major concomitant disease or any physical or psychological disorder within the last five years, which might be considered life threatening or which might confound the collection or interpretation of the study data. * the subject has experienced two or more severe hypoglycemic events - seizures/coma requiring assistance in the past 6 months.
stent-retriever for acute massive pulmonary embolism (srame)

Conditions: PE - Pulmonary Embolism; PE - Pulmonary Thromboembolism

Summary: to evaluate treatment outcomes of patients diagnosed with pulmonary embolism.


Eligibility criteria:
inclusion criteria: - 1.18≤ age ≤75, no gender limitation; 2.patients clinically diagnosed as acute pulmonary embolism requiring pulmonary artery thrombosis clearance; 3.rv/lv ratio ≥0.9; 4.patients who agreed to participate in the study and voluntarily signed the informed consent. exclusion criteria: 1. patients with systolic blood pressure\<90 mmhg and lasting for 15 minutes or requiring maintenance of systolic blood pressure ≥ 90 mmhg; 2. patients with known severe pulmonary hypertension; 3. patients with hematocrit \<28%; 4. patients with known structural heart disease; 5. patients with left bundle branch block; 6. patients with history of chronic left heart failure and left ventricular ejection fraction ≤30%; 7. patients with abnormal renal function (serum creatinine \> 1.8 mg/dl or \>159 umol/l); 8. patients with known coagulopathy or bleeding tendency (platelet \ 3); 9. patients who cannot receive antiplatelet or anticoagulant therapy; 10. patients who underwent cardiovascular or pulmonary open surgery within 7 days before peocedure; 11. patients with intracardiac thrombosis; 12. patients treated with extracorporeal membrane oxygenation; 13. patients known to be allergic to contrast agents; 14. patients with diseases that may cause difficulty in treatment or evaluation (such as malignant tumor, acute infectious disease, sepsis, general condition that cannot tolerate procedure, life expectancy less than one year, etc.); 15. females who are pregnant or in lactation; 16. patient is currently enrolled in another investigational study protocol; 17. other conditions not suitable for inclusion judged by the researcher.
people living with hiv, oral and oropharyngeal cancer, and health equity

Conditions: HIV Infections; Oral Squamous Cell Carcinoma; Oropharyngeal Squamous Cell Carcinoma

Summary: this is an exploratory qualitative study among people living with hiv (plwh) of diverse racial/ethnic and sexual and gender minority (sgm) identities to explore individual, interpersonal, and structural oral health equity factors that serve as barriers or facilitators of accessing oral health care, knowledge and perceptions of human papillomavirus (hpv) vaccination and oral squamous cell carcinoma (oscc) /oropharyngeal squamous cell carcinoma (opscc), and to collect recommendations on how to increase access to oral health care and engage plwh in oscc/opscc prevention.

objectives: 1. to identify individual, interpersonal, and structural oral health equity factors (e.g., internalized stigma; enacted stigma; transportation/hours) that serve as barriers or facilitators to accessing regular and appropriate oral health care, among plwh of intersecting racial/ethnic and sgm groups. 2. to explore knowledge and perceptions about causes, risk factors, prevention, and screening for oscc/opscc and hpv vaccination and if identity group membership influences knowledge and perceptions of these issues. 3. to elicit recommendations for improving access to regular and appropriate oral health care, and suggestions on how to engage plwh from diverse identity groups in prevention interventions. outline: there will be one screening and enrollment phone call and only one study visit for the focus group discussions (fdgs). a short quantitative survey will be administered.

Eligibility criteria:
inclusion criteria: * participants must be 18-years old or older. * participants must be individuals living with hiv * ability to speak and understand english * identify as one or more racial/ethnic minority groups or sexual and gender minority groups * all genders and members of all races and ethnic groups are eligible for this study. exclusion criteria: * younger than 18-years old. * not living with hiv. * not able to speak and understand english. * not classified as one or more racial/ethnic minority groups or sexual and gender minority groups.

Keywords: health equity focus group sexual and gender minority people living with hiv hpv, human papillomavirus
effect of vimala massage versus hydrotherapy on the clinical outcomes of neonatal hyperbilirubinemia

Conditions: Neonatal Jaundice

Summary: the aim of this study is to evaluate the effect of vimala massage versus hydrotherapy on the clinical outcomes of neonatal hyperbilirubinemia.

the researchers explained the study's aim, benefits, and procedures for participation, after that the parents of the neonates provided an informed consent. neonatal baseline data was collected from their records on the first day of admission for the three groups prior to intervention in order to identify neonates who meet the required criteria of the study. then the participants were selected and divided randomly (using a simple random method) into three equal groups. one subject for the control group, one for the study group (i), then the other for study group (ii), and so on, distributed the participants into three equivalent groups as fellow: control group: consisted of 30 newborns who will receive conventional hospital care with no additional interventions. study group (i): consisted of 30 neonates who will receive vimala massage. the massage will be given three times per day, each lasting 15 minutes and planned one hour after the first feeding of each shift. study group (ii): consisted of 30 neonates who will receive hydrotherapy. it will be applied two times per day before feeding, each lasting 5-10 min.

Eligibility criteria:
inclusion criteria: full-term neonates aged 37- 42 weeks of gestation with a birth weight of ≥1500 g and a five-minute apgar score of seven or above. furthermore, the newborn with physiological jaundice will be admitted for phototherapy from the first to the tenth day, and the infant's vital signs will remain normal exclusion criteria: * major congenital malformations, intestinal obstruction, congenital heart disease, sepsis, neonates with a disease that disrupts skin integrity (epidermolysis bullosa, ichthyosis, collodion baby).
time-to-detection in culture of mycobacterium tuberculosis

Conditions: Pulmonary Tuberculoses

Summary: determination if time-to-detection in cultures of m. tuberculosis samples is more discriminating than acid-fast staining in transmission


Eligibility criteria:
inclusion criteria: * have at least 1 contact case explored for tuberculosis * latent tuberculosis infection exclusion criteria: -