Kornimate/medical-research-clean huggingface dataset:
health effects of early-life exposure to urban pollutants in minority children

Conditions: Asthma; Development

Summary: a molecular epidemiologic study of african american and hispanic mothers and newborns to investigate the role of common urban pollutants on procarcinogenic and developmental damage.

the major objective of the proposed research is to study the impact of early-life exposures to common urban pollutants on neurobehavioral development and asthma in a sample of children living in three low-income, minority communities of new york city (central harlem, washington heights and the south bronx). using a molecular epidemiologic approach with monitoring, biomarkers, and clinical assessments at serial time points, we will extend our study of african-american and latina urban mothers and children in order to follow the cohort through child age 11 years to assess the longer-term impact of exposures on child health and developmental outcomes.

Eligibility criteria:
enrollment eligibility was restricted to nonsmoking pregnant women 18-35 years of age who self-identified as either african american or dominican and who had resided in northern manhattan or the south bronx in new york city for at least 1 year before pregnancy. women were excluded if they used illicit drugs, had diabetes, hypertension, or known hiv, or had their first prenatal visit after the 20th week of pregnancy.

Keywords: pollutants
safety study on stopping anticoagulation medication in patients with a history of atrial fibrillation

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine whether it is safe to stop anticoagulation medication in patients with a history of atrial fibrillation (af) based on information from a pacemaker or implantable cardioverter defibrillator (icd).


Eligibility criteria:
inclusion criteria: * patient has a st jude medial device that is compatible with merlin.net (remote monitoring) * patient has history of atrial fibrillation (non-continuous) * patient must be taking a a blood thinner medication other than warfarin or aspirin for atrial fibrillation * patient is willing to complete a questionnaire exclusion criteria: * patient is in atrial fibrillation all of the time * patient has a history of stroke or blood clot * patient is on warfarin or coumadin * patient cannot be taken off of his blood thinner medication due to another medical condition * patient is not capable of sending a remote device transmission to doctor once a week
study of amg 160 in subjects with non-small cell lung cancer

Conditions: Non-small Cell Lung Cancer; NSCLC

Summary: this study aims to evaluate the safety and tolerability of amg 160 and to evaluate the maximum tolerated dose (mtd) or the recommended phase 2 dose (rp2d).


Eligibility criteria:
inclusion criteria: * participant has provided informed consent prior to initiation of any study specific activities/procedures. * histologically or cytologically confirmed stage 4 or recurrent non-squamous nsclc (part 1); histologically or cytologically. confirmed stage 4 or recurrent nsclc (part 2 only, squamous cell histology/cytology allowed in part 2). * without a driver mutation: disease progression following at least one line of prior chemotherapy and at least 1 prior anti-programmed cell death protein 1 (pd1)/programmed death-ligand 1 (pdl1) therapy. * with a driver mutation must experience disease progression on at least 1 targeted therapeutic agent to be eligible. * detectable prostate-specific membrane antigen (psma) expression by psma positron emission tomography (pet)/computed tomography (ct) imaging. * measurable disease by modified response evaluation criteria in solid tumors (recist) 1.1 criteria. * eastern cooperative oncology group (ecog) performance status (ps) of 0- 2. exclusion criteria: * radiographic evidence of intratumor cavitation, major blood vessel invasion or encasement by cancer. * untreated or symptomatic brain metastases and leptomeningeal disease. * history of hemoptysis within 3 months prior to first dose. * history or evidence of gastrointestinal inflammatory bowel disease (ulcerative colitis or crohn disease). * myocardial infarction, unstable angina, cardiac arrhythmias requiring medication, and/or symptomatic congestive heart failure (new york heart association \> class ii) within 12 months prior to start of dosing. * vasculitis or grade 3/4 gastrointestinal bleeding within 3 months prior to first dose; vascular disease (eg, aortic aneurysm requiring surgical repair or recent peripheral arterial thrombosis) within 6 months of first dose. * gastrointestinal (gi) perforation and/or fistulae within 6 months prior to start of dosing. * interstitial lung disease or a history of pneumonitis that required oral or intravenous glucocorticoids to assist with treatment. * evidence of bleeding diathesis or coagulopathy (in the absence of therapeutic anticoagulation). * chronic systemic corticosteroid therapy or any other immunosuppressive therapies unless stopped 7 days prior to first dose. * any biological therapy or immunotherapy within 3 weeks of start of first dose. * major surgery within 4 weeks of first dose. * infection requiring iv antimicrobials for management within 7 days of dosing. * known human immunodeficiency virus (hiv) infection, hepatitis c infection. * active autoimmune disease

Keywords: amg 160 phase 1b
bikram yoga and asthma

Conditions: Asthmatics

Summary: cold and dry air induce exercise induced asthma. yoga training may improve lung function tests. bikram yoga (heat 39 degree celsius and humidity 60%)training may improve both lung function tests and bronchial hyperreactivity (to exercise and adenosine 5'monophosphate).

15 young adults with exercise induced asthma and 10 healthy young adults will participate in 2 months taining of bikram yoga in tel aviv. they will perform sessions of 90 minutes training at least 5 times a week. lung function tests, bronchial challenges (exercise and amp) and progressive exercise test will be performed before and after the 2 month training at hadassah university hospital in jerusalem in the asthmatic patients. healthy adults will perform only lung function tsts and progressive exercise before and after training.

Eligibility criteria:
inclusion criteria: * controlled asthma * age 18-30 years exclusion criteria: * heart, * hypertension, * kidney disease, * chronic lung disease, * oxygen dependence

Keywords: asthma yoga heat humidity bikram
intervention study of oral health education programs directed to adolescents

Conditions: Gingivitis; Periodontal Infection

Summary: this study evaluates behavioral interventions to increase adolescent's motivation for self performed periodontal infection control, by means of adequate oral hygiene. study subjects will be allocated to test and control group where the test will be subjected to an individually tailored oral health education program, based on cognitive- behavioral theory and principles, and the control to standard educational intervention.

the prevalence of chronic periodontitis is about 40% among the swedish adult population. the key-factor for the prevention of periodontal disease progression is the establishment of periodontal infection control, by means of adequate daily oral hygiene. hence, a main task for dental professionals is to educate and motivate the patient to such beneficial behavior. a hypothesis for the current study is that patient centered health promotion programs based on cognitive behavioral theory and principles and with a directive communicative approach, i.e. motivational interviewing techniques, add positive and lasting effects to standard educational interventions on self-performed periodontal infection control. this randomized clinical field study involves 30 professionals (dental hygienists) and about 350 adolescent patients at 16 dental clinics in the västra götaland region, sweden. the approach in the evaluation is on patient-centered outcomes and health economics.

Eligibility criteria:
inclusion criteria: * 16 or 17 years old at inclusion * poor oral hygiene conditions (dental plaque and/or marginal gingival bleeding at \>50% of tooth surfaces) at the time of examination and thus considered to be at increased risk for oral/periodontal disease progression. exclusion criteria: * compromised medical or mental conditions that may requiring special care.

Keywords: gingivitis adolescents oral hygiene oral health behavior periodontal infection control
study of regn2810 in patients with advanced cutaneous squamous cell carcinoma

Conditions: Advanced Cutaneous Squamous Cell Carcinoma

Summary: the goals of this study are to evaluate the clinical benefit and safety of cemiplimab in participants with metastatic (nodal or distant) cutaneous squamous cell carcinoma (cscc), or unresectable locally advanced cscc.


Eligibility criteria:
key inclusion criteria: * at least 1 measurable lesion * eastern cooperative oncology group (ecog) performance status ≤1 * adequate bone marrow function * adequate renal function * adequate hepatic function * archived or newly obtained tumor material * patients must consent to undergo biopsies of cscc lesions (groups 2, 4, and 6) * surgical or radiological treatment of lesions contraindicated key exclusion criteria: * ongoing or recent (within 5 years) evidence of significant autoimmune disease that required treatment with systemic immunosuppressive treatments, which may suggest risk for immune-related adverse events * prior treatment with an agent that blocks the pd-1/pd-l1pathway * prior treatment with a braf inhibitor * prior treatment with other immune-modulating agents within fewer than 4 weeks prior to the first dose of cemiplimab, or associated with immune-mediated adverse events that were ≥ grade 1 within 90 days prior to the first dose of cemiplimab, or associated with toxicity that resulted in discontinuation of the immune-modulating agent. examples of immune-modulating agents include therapeutic vaccines, cytokine treatments, or agents that target cytotoxic t-lymphocyte antigen 4 (ctla-4), 4-1bb (cd137), or ox-40. * untreated brain metastasis(es) that may be considered active * immunosuppressive corticosteroid doses (\>10 mg prednisone daily or equivalent) within 4 weeks prior to the first dose of cemiplimab * infection with human immunodeficiency virus (hiv) and/or chronic/active infection with hepatitis b virus or hepatitis c virus * history of non-infectious pneumonitis within the last 5 years * allergic reactions or acute hypersensitivity reaction attributed to antibody treatments * known allergy to doxycycline or tetracycline * patients with a history of solid organ transplant * any medical co-morbidity, physical examination finding, or metabolic dysfunction, or clinical laboratory abnormality that renders the patient unsuitable other protocol-defined inclusion/exclusion criteria apply

Keywords: metastatic cscc unresectable locally advanced cscc
understanding adaptive challenges associated with male-factor infertility

Conditions: Male-factor Infertility

Summary: the purpose of this study is to understand the experience of men and their partners when diagnosed with male-factor infertility while trying to achieve a pregnancy and the skills they use to adapt to this diagnosis.


Eligibility criteria:
inclusion criteria: men: * in a partnered relationship with a female * have been trying without success to conceive a pregnancy * have been referred due to suspected or diagnosed male-factor infertility * have the ability to read and write english female partner: * 18 to 40 years of age * ability to read and write english exclusion criteria: * living children, either biological or adoptive * history of vasectomy
post-market celect platinum vena cava filter and gunther tulip retrieval set study

Conditions: Deep Vein Thrombosis; Venous Thromboembolism; Pulmonary Embolism

Summary: this prospective, observational, post-market study will be performed to collect patient-level data on the celect platinum vena cava filter sets and the günther tulip vena cava filter retrieval set to confirm continued safety and performance of the devices throughout their expected lifetime and continued acceptability of the benefit:risk ratio. additionally, the study intends to evaluate longer-term (i.e., up to 5 years) outcome data while the filter is indwelling.


Eligibility criteria:
inclusion criteria: * a patient dataset is deemed suitable for inclusion if the patient has a procedure where a celect platinum vena cava filter is placed * subject has not previously participated in the cook mdr-2126 study. exclusion criteria: * patients will be excluded from enrollment if the patient or his/her legally authorized representative objects to collection and processing of his/her data or is not willing to sign the informed consent.

Keywords: celect platinum vena cava filter gunther tulip vena cava filter retrieval set
conservative versus non-conservative treatment for severe dental caries

Conditions: Dental Caries

Summary: the purpose of this study is to compare the effectiveness of the conservative (pulpectomy) versus non-conservative treatment (tooth extraction) of primary molars affected with severe dental caries associated to oral health-related quality of life, anthropometric and clinical outcomes.

treatment: evaluate two interventions for treating severe dental caries in primary molared of preschool children. sample: preschool children aged 3 to 5 years with severe dental caries (sdc) in primary molars. sdc will be indicated by the pufa index. the pufa index records the presence of severely decayed teeth with visible pulp involvement (p), ulceration of the oral mucosa owing to root fragments (u), fistula (f) and abscess (a). children with pufa-score \> 0 in primary molars will be included in the study. all children aged 3 to 5 years, who sought dental screening at the dental school, university of são paulo (usp) in august to october 2013 can be initially eligible. clinical groups randomly assigned: * group a: conservative treatment represented by pulpectomies + teeth restoration with composite resin crown. * group b: dental extraction * treatment of carious teeth with pufa score =0 will receive dental fillings (01 occlusal surface affected: art; 02 surfaces affected: composite resin; ≥ 03 surfaces affected: composite resin crown). * one operator (specialists in paediatric dentistry) blinded to the outcomes will carry out the treatments. follow-up: 4, 8 and 12 months. outcomes: all outcomes will be assessed by a single person interviewer/examiner blinded to the oral treatments groups. 1. oral health-related quality of life: * brazilian soho-5 * brazilian ecohis 2. anthropometric measures: * weight-for-age z-score (waz) * height-for-age z-score (haz) * bmi-for age z-score (baz) 3. dental anxiety (facial image scale). 4. dental pain (wong-baker scale) 5. problems in the developing occlusion: loss of space

Eligibility criteria:
inclusion criteria: * preschool children with severe dental caries (sdc) in primary molars. * sdc will be indicated by the pufa index * the pufa index records the presence of severely decayed teeth with visible pulp involvement (p), ulceration of the oral mucosa owing to root fragments (u), fistula (f) and abscess (a). children with a pufa-score \> 0 will be included in the study. exclusion criteria: * children with severe crowding of anterior teeth * severe arch length deficiencies * children with systemic and neurological diseases or those with illnesses that adversely affect growth according to parents reports * children on regular nutrition supplements * children who had undergone dental treatment in the last three months and who were not willing to participate in the study. tooth with anomalies, extensive crown destruction and impossibility of absolute isolation in the conservative intervention group.

Keywords: dental caries quality of life pulpectomy tooth extraction
virtual a2 study for at risk children

Conditions: Hypoxic Ischaemic Encephalopathy (HIE); Premature Birth; Cerebral Palsy; Neurological Disorder

Summary: the goal of this behavioral-interventional study is to learn if the abecedarian approach implemented virtually for children ages 0-5 with a history of hypoxic ischaemic encephalopathy (hie) and/or premature birth produces the same effects as when administered at in-person facilities.


Eligibility criteria:
inclusion criteria: 1. ipnh-ndcp patients, including: * term-born children diagnosed during the neonatal period with hypoxic-ischemic encephalopathy, or * premature children (born at less than 28 weeks gestational age). 2. parent or legal guardian will also be enrolled as a participant 3. parents must be english-speaking (able to provide consent and complete questionnaires). exclusion criteria: 1. not suitable for study participation due to other reasons at the discretion of the investigator. 2. infants with chromosomal abnormalities, genetic syndromes (for example, such as down syndrome or trisomy18) and major congenital malformations will be excluded. 3. infants with vision impairment will also be excluded from the study, as our study procedures do require intact vision to be able to complete. 4. for parents or legal guardians, there are no exclusion criteria.
multimodal prehabilitation in frail and non-frail patients waiting for a kidney transplantation (the frailmar study)

Conditions: Chronic Kidney Diseases

Summary: frailty is very frequent among patients waiting for a kidney transplantation (kt). frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcare utilization after kt. frailty in patients with chronic kidney disease (ckd) displays a constellation of features that characterize a special population. intervention is essential to improve quality of life for frail ckd patients, regardless of their age. a pre-transplant intervention including physical therapy, nutritional measures and psychological support scheduled for before the transplant may improve patient retention and compliance, better mitigate the effects of frailty and poor fitness after kt, and improve main outcomes in frail ckd patients. the main objective is to assess effectiveness, feasibility and safety of a prehabilitation program (exercise, nutritional plans, psychological advice) in frail and non-frail kt candidates on clinical and functional outcomes after kt.

frailty is very frequent among patients with chronic kidney disease (ckd) included in the waiting list for deceased donor kidney transplantation (kt), and outcomes are worsened in those frail recipients after kt. frailty and poor fitness powerfully predict mortality, kidney graft survival, and healthcareutilization after kt. frailty in ckd patients displays a unique constellation of features such as muscle wasting, anorexia, protein energy wasting, inflammation, oxidative stress, catabolic/anabolic hormone imbalance, metabolic acidosis, and other cellularalterations that characterize a special population. intervention is essential to improve quality of life for frail ckd patients, regardless of their age. efforts to intervene with post- transplant physical therapy have been met with limited success, in large part due to high study dropout. a pre-transplant clinical framework for multimodal prehabilitation interventions including physicaltherapy, nutritional measures and psychological support scheduled for before the transplant may improve patient retention andcompliance, better mitigate the effects of frailty and poor fitness after kt, and improve main outcomes in frail ckd patients. the main objective of this study is to assess effectiveness, feasibility and safety of multimodal prehabilitation (exercise, nutritional plans, psychological advice) in frail and non-frail kt candidates in the context of a randomized controlled clinical trial. the primary endpoint will be a composite achievement of clinical and functional outcomes in frail and non-frail kt candidates after kt.

Eligibility criteria:
inclusion criteria: * adults patients with chronic kidney disease * inclusion in the waiting list for deceased donor kidney transplantation in the period september 2020 to august 2022 exclusion criteria: * patients unable to perform the exercise plan or giving informed consent

Keywords: chronic kidney disease kidney transplantation frailty prehabilitation exercise nutritional status psychological advice sarcopenia
prevention of postpartum depression: a pilot placebo-controlled trial of trazodone

Conditions: Postpartum Depression

Summary: postpartum depression is a serious illness that affects approximately 17% of women who have recently given birth. untreated depression appears to have negative effects for both the mother and her baby. postpartum depression is quite common among women with a history of depression. sleeplessness is a common concern during pregnancy and after delivery, and it can also trigger depression in women with a history of depression. antidepressants are the most commonly recommended drugs for prevention of postpartum depression; however, there is limited research to understand the effectiveness of the medications in preventing postpartum depression. trazodone is a weak antidepressant, but it is commonly prescribed for sleeplessness due to physical or psychiatric disorders. we are planning a study to find out whether trazodone in a low dose is more effective than a sugar pill in preventing postpartum depression among women with histories of depression. we expect the results of our study will make it easier for healthcare providers to select the right medication for women who are at risk of developing depression after delivery and thus improve the mental health of mothers and well-being of their babies.


Eligibility criteria:
inclusion criteria: healthy outpatients with a history of major depressive disorder who are currently not on any psychotropic medications and who: 1. are 18- 45 years old, 2. are pregnant with gestation of 28-34 weeks, 3. have been in full remission of depression for \> 2 months (as per diagnostic and statistical manual-5), 4. are able to communicate in english, 5. are capable of providing informed consent, 6. are planning to deliver at victoria hospital in london ontario, and 7. live in london and the surrounding area, will be enrolled. exclusion criteria: 1. current psychiatric disorder other than generalized anxiety, 2. use of psychotropic medication over the previous 2 months, 3. history of bipolar disorder or psychosis, 4. high risk for suicide (actively suicidal or a score of ≥ 3 on item #3 on the hamilton depression rating scale-17 item \[hdrs\]), 5. currently receiving psychotherapy

Keywords: postpartum depression trazodone prevention
durability of nevirapine-based antiretroviral regimen

Conditions: HIV Infections

Summary: although nevirapine is used as an alternative to efavirenz for initial regimen in developed countries, nevirapine has still been a key antiretroviral drug in many resource-limited countries including thailand due to its accessibility and affordability. in addition, a component of stavudine and lamivudine is still widely used as a backbone in the antiretroviral regimen in this setting.to date, data on the durability of a regimen of stavudine, lamivudine and nevirapine are very limited, particularly from the resource-limited settings.


Eligibility criteria:
inclusion criteria: * hiv-infected individuals ≥15 years of age * cd4 cell count \<350 cells/mm3 * willing to participate and give consent form exclusion criteria: * previous antiretroviral therapy * pregnancy * receiving a medication that has drug-drug interactions with nvp or rfp * aspartate aminotransferase (ast) and alanine aminotransferase (alt) \>5 times of upper limit of normal range

Keywords: hiv nevirapine durability aids treatment naïve