Kornimate/medical-research-clean huggingface dataset:
a study to evaluate the safety and efficacy of medi8897 for the prevention of medically attended lower respiratory tract infection due to respiratory syncytial virus in healthy late preterm and term infants (melody)

Conditions: Respiratory Syncytial Virus Infections

Summary: the purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (pk), and antidrug antibody (ada) response for medi8897 in healthy late preterm and term infants who are 35 weeks or greater gestational age and entering their first rsv season.

this pivotal phase 3 study will determine if medi8897 will prevent medically attended rsv-confirmed lower respiratory tract infections (lrti) in healthy infants entering their first rsv season. the population to be enrolled is healthy late preterm and term infants born 35 weeks 0 days or greater gestational age (ga) who would not be eligible to receive rsv prophylaxis. a total of approximately 3,000 infants will be randomized 2:1 to receive either medi8897 or placebo. all subjects will be followed for approximately 510 days after dosing. enrollment is planned at approximately 350 sites across the usa, canada, europe, asia, and southern hemisphere.

Eligibility criteria:
key inclusion criteria: * healthy infants in their first year of life and born at or after 35 weeks 0 days ga * infants who are entering their first rsv season at the time of screening key exclusion criteria: * meets national or other local criteria to receive commercial palivizumab * any fever (≥ 100.4°f \[≥ 38.0°c\], regardless of route) or acute illness within 7 days prior to randomization * active rsv infection (a child with signs/symptoms of respiratory infection must have negative rsv testing) or known prior history of rsv infection * receipt of palivizumab or other rsv monoclonal antibody or any rsv vaccine, including maternal rsv vaccination

Keywords: respiratory syncytial virus rsv late preterm infants healthy infants lower respiratory tract infection
kharituwe tb contact tracing study

Conditions: Tuberculosis; Hiv

Summary: the purpose of this study is to characterize the role of human mobility in fueling tb epidemics and estimate the potential impact of innovative case finding interventions tailored to mobile populations

the investigators propose a randomized trial of two novel tb case-finding interventions among household members of patients diagnosed with active tb: holiday-based screening in a rural south african province (limpopo) and off-peak (weekend/evening) screening in an urban settlement into which many residents of limpopo migrate for work. the investigators will enroll index cases of tb plus their household contacts in each setting and randomize them to novel versus standard contact investigation. in specific aim 1, investigators will use whole genome sequencing of all cases, overlaying transmission trees with data on human movement, to evaluate associations between mobility and tb transmission in this population. in specific aim 2, investigators will employ a multidisciplinary approach to compare novel versus standard contact investigation in each setting along the following dimensions: (a) effectiveness (number of secondary tb cases diagnosed and starting treatment); (b) implementation (reach, fidelity, and maintenance of contact investigation outside of business hours); (c) cost-effectiveness (cost per disability-adjusted life year) and budget impact; and (d) projected population-level impact on tb incidence. successful completion of these aims will have long-term impact by characterizing the role of mobility in fueling tb epidemics and testing two tailored approaches to improve tb control in highly mobile populations - an underserved group that is increasingly recognized as playing a major role in global tb transmission.

Eligibility criteria:
tb index cases: inclusion criteria: * age 0-99 years (including those recently deceased) * diagnosed with pulmonary tb at a study hospital or clinic (microbiological and/or chest x-ray diagnosis) exclusion criteria: * unwilling/unable to provide informed consent (including next of kin, for those recently deceased) * plan not to pursue tb treatment within the study district * unwilling/unable to comply with study procedures contacts: inclusion criteria: * age 0-99 years * currently resides with or visiting eligible tb index case exclusion criteria: * unwilling/unable to provide informed consent * unwilling/unable to comply with study procedures
cardiovascular status in patients with endogenous cortisol excess (cushing's syndrome)

Conditions: Endogenous Cushing's Syndrome

Summary: within this trial, the cardiovascular and mental status as well as the metabolic profiles of patients with endogenous cortisol excess are evaluated.

endogenous cushing's syndrome (cs) is associated with increased cardiovascular (cv) morbidity and reduced general health status. it has been shown that these impairments may be reversible after cure of hypercortisolism. however, previous studies were restricted to selected cv aspects. the primary aim of the cv-cort-ex study is to comprehensively assess left ventricular function and morphology of patients with endogenous cs. secondly, we examine long-term changes of cv function, endothelial function, psychosocial status, bio-impedance, and quality of life. within the longitudinal study, patients will be investigated at initial diagnosis and at least 6 months after cure of cs. within the cross-sectional study, we aim to comprehensively phenotype patients with endogenous cs and unknown cv disease. results will finally be compared with healthy controls.

Eligibility criteria:
inclusion criteria: * written informed consent * age ≥18 years * cross-sectional study:history of clinically and biochemically proven endogenous cushing's syndrome (overt or subclinical) * longitudinal study: patients with clinically and biochemically proven endogenous cushing's syndrome (initial diagnosis or recurrent disease) exclusion criteria: * glucocorticoid pharmacotherapy for \>12 months within the previous 3 years * structural heart disease, chronic heart failure (\>nyhaii), systemic or single organ disease potentially affecting cardiac function * arterial hypertension (uncontrolled with \>3 antihypertensive drugs) * pregnancy * drug abuse * cardiac magnetic resonance imaging (cmri) substudy: patients with renal failure are excluded from the cmri study (mdrd \<60)

Keywords: endogenous cushing's syndrome cardiovascular status metabolic profile endothelial function quality of life
urotherapy vs. urotherapy with constipation treatment for nocturnal enuresis

Conditions: Nocturnal Enuresis

Summary: constipation treatment has been found to ameliorate symptoms in some patients with nocturnal enuresis (bed wetting at night). this study aims to explore if treatment of patients without overt constipation (as defined by the rome iii criteria) will also respond to stool softening and gi behavioral therapy with reduction of their urinary tract symptoms when added to standard urotherapy.


Eligibility criteria:
inclusion criteria: 1. aged 5-17 years at time of signing of informed consent. 2. mne as defined by ≥3 wet nights/week without daytime incontinence 3. do not meet rome iii criteria for functional constipation exclusion criteria: 1. inability to provide signed informed consent. 2. inability to comply with the study protocol. 3. neurogenic bladder 4. attention deficit disorder (add or adhd) on medical treatment. 5. known significant sacral, perineal, or other congenital or surgical defect. 6. known orthopedic/neurological disease which may affect urinary continence, cause constipation, or affect reading of abdominal x-rays. (e.g. spastic cerebral palsy, severe scoliosis) 7. patient taking medicinal drugs which can cause urinary incontinence or constipation.

Keywords: constipation
e-cigarette harm reduction among plwha in south africa

Conditions: Tobacco Smoking

Summary: the purpose of this pilot randomized controlled trial study aims to address the unmet need for feasible and efficacious strategies for reducing combustible cigarette (cc) use among people living with hiv/aids (plwha) in south africa, which has the potential to significantly improve the health and long-term survival of plwha cc smokers. using the proposed intervention, based on the information-motivation-behavioral skills (imb), and a simultaneous embedded mixed methods approach, the investigators will evaluate a telehealth program targeting cc harm reduction, comparing e-cigarettes (ec) to nicotine replacement therapy (nrt) that is enhanced by integrating ecological momentary intervention (emi) texting. as such, this proposal will significantly build research capacity in south africa to conduct telehealth tobacco treatment interventions using innovative emi approaches enhancing participants' engagement, as well as state-of-the art evaluation approaches.


Eligibility criteria:
inclusion criteria: * adult plwha cc smokers; * speaks afrikaans, or xhosa, or english; * reports daily cc smoking (≥ 5 cpd); * owns any type of mobile phone; * interested in reducing cc smoking but not necessarily trying to quit; * receives hiv/aids care in one of the eight selected clinics follow-up rates. exclusion criteria: * are pregnant or breastfeeding; * unable to provide consent; * used tobacco products other than cc in the past 2 weeks (e.g., ec, cigarillo); * currently engaged in an attempt to quit cc smoking; * current major depressive or manic episode, current psychotic disorder, past-year suicide attempt, or current suicidal ideation with plan or intent. plan or intent.
effects of sea buckthorn oil on dry eye

Conditions: Dry Eye Syndromes

Summary: the objective is to study the effect of sea buckthorn oil on dry eye.

the objective is to study whether regular consumption of sea buckthorn berry oil can relieve the symptoms of dry eye syndrome. the study design is a parallel randomized double-blind placebo controlled trial. the participants daily consume sea buckthorn or placebo oil for 3 months. the dry eye symptoms will be monitored during the study using a validated questionnaire. in addition clinical dry eye tests are made by an ophthalmologist three time during the study. samples will be taken for tear film lipid and cytokine analyses. blood samples for the analyses of inflammatory markers are also obtained. the cytokine and other inflammation marker analyses are optional. the symptoms will be monitored and clinical tests made also 4 weeks after the participants have stopped consuming the study oils.

Eligibility criteria:
inclusion criteria: * dry eye symptoms exclusion criteria: * severe illness * anticholinergic drugs * smoking

Keywords: dry eye sea buckthorn hippophaë
crossover study of safety and tolerability of two formulations of adalimumab.

Conditions: Rheumatoid Arthritis

Summary: this study will compare injection site pain levels between current humira® formulation versus a new formulation of humira in patients with rheumatoid arthritis (ra), who are either currently on a stable dose (minimum six consecutive doses) of on-label humira or biological naïve who will be prescribed on-label humira as treatment for their rheumatoid arthritis. the study is being conducted in two countries, belgium (3 sites) and the czech republic (3 sites).

64 participants were randomized, 63 received at least one dose of the study drug, and 62 participants were analyzed for injection site-related pain. 63 participants were analyzed for other safety analyses. two participants, who were randomized to the current formulation adalimumab/new formulation of adalimumab arm of the study were excluded from the analysis of injection site-related pain. one participant received one dose of study drug and discontinued because of an adverse event, while the other discontinued before receiving any study drug.

Eligibility criteria:
inclusion criteria: * male or female subject age 18 years or older, who requires humira 40 mg sc every other week (eow) or every week (ew) for the treatment of rheumatoid arthritis, in accordance with the local humira label. * subject must be a current, on-label user of humira who rates his/her average humira injection site related pain as at least 3 cm on a pain visual analogue scale and has had at least 6 consecutive doses of humira prior to screening, or a biologic naïve subject who requires initiation of on-label treatment with humira. * subject has diagnosis of rheumatoid arthritis (ra) as defined by the 1987 revised acr classification criteria or the acr/eular 2010 criteria, * female subjects are either not of childbearing potential, defined as postmenopausal for at least 1 year or surgically sterile (bilateral tubal ligation, bilateral oophorectomy and/or hysterectomy), or are practicing at least one method of birth control throughout the study and for at least 70 days after the last dose of study drug. * all female subjects of childbearing potential must have a negative test for pregnancy on a serum sample at screening and prior to study drug dosing on a urine sample obtained at visit 1. exclusion criteria: * subject has been treated with any investigational drug of a chemical or biologic nature within a minimum of 30 days or 5 half-lives (whichever is longer) of the drug prior to visit 1. * any infection(s) requiring treatment with intravenous (iv) anti-infectives within 30 days prior to visit 1 or oral anti-infectives within 14 days prior to visit 1. * prior exposure to natalizumab (tysabri®) or efalizumab (raptiva®). * known hypersensitivity to adalimumab or its excipients. * history of demyelinating disease (including myelitis) or neurologic symptoms suggestive of demyelinating disease.

Keywords: on label humira users pain rheumatoid arthritis,
movement-based infant intervention

Conditions: Infant Development; Infant,Premature; Infant, Very Low Birth Weight; Infant, Small for Gestational Age; Infant Conditions

Summary: the objective is to pilot test the effectiveness of an evidence-based intervention to promote positive neurodevelopmental outcomes in infants at risk for developmental delay. the intervention promotes movement experience from 3 months to sitting onset.

aim: our purpose was to assess daily leg movement rate before and after a caregiver-provided in-home intervention for infants at risk for developmental disability. we also assessed adherence and quality of caregiver-child interaction. methods: twelve infants, at risk for developmental disabilities, and their caregivers participated in an intervention focused on increasing leg movements. intervention started between 3- and 6-months cor- rected age and ended once the infant was able to sit independently or at 9 months corrected age, whichever occurred first. infants were assessed monthly.

Eligibility criteria:
inclusion criteria: * infants will be 3 months of adjusted age at the first visit, +/- 10 days. infants will be defined as at risk if they qualify for high risk infant follow up care as defined by california children's services. exclusion criteria: * infants with congenital malformations of the legs will be excluded.

Keywords: infant leg movement wearable sensors early intervention
trv-chair vs manual repositioning maneuver in treatment of benign paroxysmal positional vertigo

Conditions: BPPV

Summary: comparison of treatment efficacy of a mechanical rotational chair (trv-chair) vs. manual repositioning maneuvers in bppv

open-label, randomized controlled trial comparing manual repositioning maneuvers with a mechanical rotational chair (trv-chair) in diagnosing and treating bppv. patients with suspected bppv will be randomized to either manual repositioning maneuvers or the trv-chair.

Eligibility criteria:
inclusion criteria: * characteristic (for bppv) positional nystagmus * positive dix-hallpike * positive supine roll test * medical history compatible with bppv exclusion criteria: * treatment in trv-chair within the last 6 months * exclusion of bppv diagnosis * lack of treatment cooperation * known cerebral aneurism or cerebral hemorrhage * diagnosed and treated for bppv within the past month * treatment with sedating anti-histamines within the past 7 days

Keywords: benign paroxysmal positional vertigo vertigo dizziness vestibular diseases epley maneuver trv-chair repositioning chair
store safely: rural firearm injury prevention for families

Conditions: Firearm Injury

Summary: the researchers are testing a firearm safety prevention strategy tailored for families with children who reside in a rural area. researchers hypothesize that the intervention will lead to improvements in household firearm storage.


Eligibility criteria:
inclusion criteria: * provision of signed and dated informed consent form * english-speaking * have a child under 18 living at home * own at least one firearm * reside in michigan's upper peninsula (up) * access to a computer/mobile device and wifi * have sufficient information about household storage to complete surveys exclusion criteria: * unable to be consented in english * lack of firearm in the home * no child in the home * residence outside the up * no access to technology * previously enrolled in 2020 pilot project

Keywords: rural firearm safe storage injury prevention suicide prevention community education
second uterine evacuation for low-risk gestational trophoblastic neoplasia

Conditions: Gestational Trophoblastic Neoplasia; Molar Pregnancy; Gestational Trophoblastic Tumor, Non-Metastatic

Summary: to evaluate the efficacy and safety of second uterine curettage in patients with low-risk non-metastatic gtn.

this is a randomized, multicenter clinical trial including patients seen at one of 13 gestational trophoblastic disease reference centers in brazil. subjects are eligible if they have low-risk gestational trophoblastic neoplasia according to figo 2000 criteria and the figo/who prognostic risk score. the study includes two treatment arms: immediate treatment with single-agent chemotherapy (center choice of agent) or second uterine curettage. the primary outcome is the rate of primary remission. secondary outcomes are the number of chemotherapy cycles required to achieve remission, rate of primary chemotherapy resistance, rate of relapse, and overall survival.

Eligibility criteria:
inclusion criteria: * histopathological diagnosis of molar pegnancy according to the morphological criteria described by sebire et al., who meet the diagnostic criteria for low-risk non-metastatic gtn according to figo 2000 criteria exclusion criteria: 1. high risk gtn (figo risk score ≥ 7) or metastatic disease at diagnosis of gtn (stage ii, iii or iv); 2. histopathological diagnosis of choriocarcinoma, placental site trophoblastic or epithelioid trophoblastic tumor at the second curettage; 3. previous chemotherapy treatment; 4. level of hcg at the time of gtn diagnosis less than 20 iu/l (to minimize the risk of inclusion of patients with false positive hcg, either by cross-reaction with pituitary hormones or by the presence of circulating heterophilic antibodies); 5. relapsed gtn; 6. incomplete medical records. 7. loss to follow-up; 8. voluntary desire to stop participating in the study.
an exploratory open-label clinical trial evaluating the immunogenicity of the 9-valent 2-dose hpv vaccination regimen

Conditions: HPV Infection

Summary: the goal of this study is to explore and evaluate whether a 2-dose schedule of gardasil 9 among young and mid-adult women 16-45 years of age is generally safe and immunogenic, with an antibody response that is not inferior to that observed of a 3-dose schedule of gardasil 9 among women aged 16-26 years old. the investigators thought that having a 2-dose vaccination regimen for individuals 16 to 45 would provide a more robust dataset than those of 27 to 45 years old.

the investigators will identify potential eligible subjects from the boston medical center (bmc) clinical data warehouse from the following bmc clinics: pediatrics, adolescent medicine, family medicine, obstetric/ gynecology (ob/gyn), and women's health/adult primary care. the research team will mail a recruitment opt-out letter signed by the principal investigator to the participant along with a study flyer. the recruitment letter will inform the participant that a research member may contact them via phone within two week to provide more information regarding the study. participants opting-in will be called and interviewed with the study recruitment script and eligibility will be determined. eligible participants who agree to participate (in-person or over the phone), will be scheduled to come to the boston university (bu) general clinical research unit (gcru) to complete the consent process. at the baseline visit participants will be assigned into the appropriate group (control vs. intervention) based on their age.

Eligibility criteria:
inclusion criteria: * women receiving care at boston medical center exclusion criteria: * currently pregnant * prior hpv vaccination * a history of severe allergic reaction, including known allergy to any vaccine component, specially severe allergic to yeast * immunocompromised/previous immunosuppressive therapy * thrombocytopenia or other coagulation disorder * currently breastfeeding

Keywords: gardasil immunogenicity 9-valent 2-dose hpv vaccination 9-valent 3-dose hpv vaccination
effect and safety of oral vancomycin in primary sclerosing cholangitis patients

Conditions: Primary Sclerosing Cholangitis

Summary: primary sclerotic cholangitis (psc) is an inflammatory process of sclerotic cholangitis that involves intra and extra hepatic biliary system. there is no curative treatment for this disorder. supportive and conservative treatments are the most common therapies that used for this disease. although treatments such as ursodeoxycholic acid (udca) are recommended in some situations but whereas a hypothesis is stimulatory effect of intestinal anaerobic bacteria such as cholestridium difficile as pathogenesıs of psc, so use of antibiotics is recommended for treatment of these patients. therefore according to the great role of anaerobic bacteria such as cholestridium difficile in pathogenesis, antibiotics such as metronidazole and vancomycin can be counted as recommended therapies in psc. in addition some studies correlated this effect of vancomycin to its immunomudulatory effect the cause reduction of inflammation in biliary system. but with all this detail there is no finality about effectiveness of antibiotic therapy and accordingly in this study the investigators compare oral vancomycin effect versus placebo in primary sclerosing cholangitis patients. in this double blind clinical trial 30 primary sclerosing cholangitis patients that divided in two 15 persosns group with block randomization method. in this study one group receive 250 mg oral vancomycin every 6 hours and other group receive placebo. the study duration is 12 weeks . the baseline laboratory tests and 1 month and 3 months after treatment concept of; alkaline phosphatase, alt, ast, ggt and serum total bilirubin and clinical manifestations such as tiredness, itching and probable adverse effects such as hypotension accompanied by flushing,erythematous rash on face and upper body (red neck or red man syndrome), chills and drug fever, eosinophilia and reversible neutropenia.


Eligibility criteria:
inclusion criteria: 1. primary sclerosing chollangitis diagnosis more than 3 months 2. inflammatory bowel disease with cholestasis diagnosis more than 3 months 3. confirmed rcpm 4. confirmed pathology of inflammatory bowel disease exclusion criteria: 1. signs of uncompensated cirrhosis like: hepatic encephalopathy, esophageal varices bleeding 2. gastrointestinal cancer or hepatic cancer 3. immunosuppressive agent using for hepatic problem (not vancomycine hypersensitivity)