Kornimate/medical-research-clean huggingface dataset:
paroxysmal atrial fibrillation: role of inflammation, oxidative stress injury and effect of statins

Conditions: Atrial Fibrillation

Summary: the purpose of this study is to determine the effect of statin therapy for prevention of atrial fibrillation (af) in pacemaker and non-pacemaker patients with paroxysmal atrial fibrillation in the absence of significant coronary artery disease.

patients with a history of paroxysmal atrial fibrillation, with or without a dual chamber pacemaker and who meet all study criteria, will be randomized to receive either a placebo, or simvastatin 40 mg, daily for 6 months. liver enzymes are drawn at randomization and 3 months. crp and oxidative stress products are drawn at randomization, weekly for the first month and then monthly for 5 months. patients transmit their rhythm, twice daily for 5 consecutive days at randomization, then 5 consecutive days monthly for 6 months. clinic visits are required at randomization, 3 months and 6 months.

Eligibility criteria:
inclusion criteria: * patients with paroxysmal af (\> 3 epis each \> 15 min in length) over 6 months * patients on stable antiarrhythmic drug therapy and life expectancy \> 1 year exclusion criteria: * patients with paf due to reversible cause * chronic inflammatory conditions * other medical conditions requiring statin therapy * patients on amiodarone or verapamil * elevated ck or alt * life expectancy \<1 year * tavn ablation * geographic isolation * inability to give informed consent

Keywords: atrial fibrillation statin therapy crp levels paroxysmal atrial fibrillation
the relative effects of three parent-intervention components to reduce children's anxiety

Conditions: Anxiety

Summary: this trial will test the relative effects of three parent-intervention components to reduce emerging anxiety problems in children aged 7-11. the components are: reducing family accommodation (component a), increasing empathetic reactions to children's anxiety (component b), and cognitive restructuring to reduce maladaptive parental thoughts about children's anxiety (component c). the components were selected based on their distinct theoretical backgrounds and their frequent use in existing intervention programs. the investigators will use a full factorial experiment with all possible combinations and orders of components. the study period will be twelve weeks with five points of data-collection: t0 (baseline), t2 (two weeks post baseline, immediately after the first component), t4 (four weeks post baseline, immediately after the second component), t6 (six weeks post baseline, immediately after the third component) and t12 (12 weeks post baseline, follow-up). our overarching research questions are: * how effective are component a, b, and c in reducing children's anxiety symptoms? the effects of the components will be compared with each other, and with a control condition. this will be investigated both from t0 to t2 (i.e., effects of the individual components) and from t0 to t6 and t0 to t12 (i.e., effects of the components controlled for the presence of other components). * how effective are the components in reducing children's life impairment? the effects of the components will be compared with each other, and with a control condition. * are effects of the components on children's anxiety mediated by changes in the parental risk factors that they target? (i.e., family accommodation for component a, empathetic reactions for component b, and parental maladaptive beliefs about child anxiety for component c) * is there a dose-response effect such that children whose parents received more intervention components benefit more in terms of reduced anxiety symptoms in children? * what parent, child, and intervention characteristics moderate the effects of the components on children's anxiety? in addition to basic sociodemographic information, the investigators will collect data on several putative moderators: the extent to which parents see their child as part of themselves (inclusion of child in the self scale), children's behavioural inhibition (behavioural inhibition questionnaire), therapist alliance (session rating scale), acceptability of the intervention (tei-sf), other caregiver's use of the intervention components.


Eligibility criteria:
inclusion criteria: * child aged 7;0 - 11;11 years old * score of ≥ 4 on the screening questionnaire "overall anxiety severity and impairment scale for youth" (oasis-y; comer et al., 2022) filled in by parents. exclusion criteria: none

Keywords: anxiety children parents prevention intervention
effect of acute cardiovascular disease on microbiome

Conditions: Microbial Colonization; Coronary Artery Disease; Myocardial Infarction; Acute Coronary Syndrome; Peripheral Arterial Disease; Critical Limb Ischemia

Summary: atherosclerotic diseases such as coronary artery disease (cad) and peripheral arterial disease (pad) are the leading cause of morbidity and mortality in the industrialized world. an interaction between the development of atherosclerotic diseases and the oral and enteral microbiome composition has already been demonstrated in the past. the microbiome is a double-edged sword which can convey protective and detrimental cardiovascular effects. while it can promote the development of atherosclerosis through the production of atherogenic metabolites such as trimethylamine n-oxide (tmao) it can also generate a protective effect through the production of metabolites such as short chain fatty acids (scfa). preliminary data suggest that atherosclerotic disease itself can induce a dysbiosis of the microbiome. aim of this study is to determine the differences in coronary artery disease and peripheral arterial disease on the oral-enteral microbiome axis and downstream microbiome-dependent metabolites.


Eligibility criteria:
inclusion criteria: * \>18 years * patient consent * ccs, acs or cli * angiographical confirmed peripheral or coronary artery disease exclusion criteria: * pregnancy/lactation period * current antibiotic treatment or in the past 3 months * chronic inflammatory bowel disease * short bowel syndrome * artificial bowel outlet * persistent diarrhea or vomiting in the past 3 months * simultaneous participation in another interfering nutrition study * active chemo or radiation therapy
safety and efficacy of etrasimod (apd334) in patients with ulcerative colitis

Conditions: Ulcerative Colitis

Summary: the purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.


Eligibility criteria:
inclusion criteria: * moderately to severely active ulcerative colitis defined as a 3-component mayo clinic score * evidence of colonic ulcerative colitis activity on endoscopy exclusion criteria: * within 30 days prior to randomization, receipt of any of the following for the treatment of underlying disease: non-biologic therapies (eg, cyclosporine, tacrolimus, tofacitinib, thalidomide), a non-biologic investigational therapy or an approved non-biologic therapy in an investigational protocol * within 60 days prior to randomization, receipt of any of the following: infliximab, adalimumab, golimumab, certolizumab, vedolizumab, any other investigational or approved biologic agent * any prior exposure to natalizumab, efalizumab, or rituximab
bronchoscopy with bronchoalveolar lavage in identifying biomarkers of response to immune checkpoint inhibitors in patients with non-small cell or small cell lung cancer

Conditions: Non-Small Cell Lung Carcinoma; Small Cell Lung Carcinoma

Summary: this pilot clinical trial studies how well bronchoscopy with bronchoalveolar lavage works in identifying biomarkers of response to immune checkpoint inhibitors in patients with non-small cell or small cell lung cancer. bronchoscopy uses a thin, tube-like instrument inserted through the nose or mouth to view the inside of the trachea, air passages, and lungs. bronchoalveolar lavage washes out the bronchi and alveoli by flushing with a fluid. bronchoscopy with bronchoalveolar lavage may make it easier to help determine biomarkers that are more present in some cancers than others that will help determine which individuals have a greater or lesser chance of benefiting from immunotherapy.

primary objectives: i. to discover predictive immune biomarkers of response to immune checkpoint inhibitor therapy in individuals with primary lung cancer. secondary objectives: i. to determine biomarkers that may be predictive of treatment related adverse events, specifically pneumonitis. ii. to further elucidate lung immunologic microenvironment by performing single cell analysis in addition to mass cytometry (cytof) on cells of bronchoalveolar lavage. outline: patients undergo bronchoscopy with bronchoalveolar lavage over 45 minutes. after completion of study, patients are followed up at 3, 6, 12, and 24 months.

Eligibility criteria:
inclusion criteria: * confirmed diagnosis of non-small cell lung cancer (nsclc) or small cell lung cancer (sclc) * candidate to undergo immune checkpoint inhibitor (ici) therapy for sclc or nsclc (ici as any line of chemotherapy is acceptable) as deemed by individual's treating oncologist * enrollment into this study may occur in tandem with other clinical therapeutics trials occurring at vanderbilt university medical center (vumc) as long as this trial does not violate protocol or inclusion criteria of that study exclusion criteria: * coagulopathy with international normalized ratio (inr) \> 2.0 or * coagulopathy with platelets (plt) \< 10 k * prior therapy with anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-ctla-4 antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways) * subjects with an active or recent history of a known or suspected autoimmune disease or recent history of a syndrome that required systemic corticosteroids/immunosuppressive medications * respiratory failure requiring greater than 6 lpm supplemental oxygen (o2) by nasal cannula or mechanical ventilation within the past six weeks * inability to perform informed consent due to any medical or psychiatric condition
research study using recombinant human insulin-like growth factor-1/recombinant human insulin-like growth factor binding protein-3 for children with noonan syndrome

Conditions: Noonan Syndrome

Summary: the trial will investigate the treatment of growth failure in children with noonan syndrome. abnormalities in the growth hormone (gh) - insulin-like growth factor-i (igf-i) axis resulting in low igf-i levels have been suggested as a possible cause of short stature seen in noonan syndrome children. administration of our investigational product is intended to bypass the abnormalities in the gh-igf axis, and hopefully improve body growth.


Eligibility criteria:
inclusion criteria: 1. a diagnosis of noonan syndrome 2. height less than the 3rd percentile for age and sex (height sds \< -1.88) 3. basal igf-i less than the mean for age and sex (igf-i sds \< 0) 4. chronological age greater than 2 years 5. bone age ≤ 11 years for boys, and ≤ 10 years for girls 6. pre-pubertal 7. documented pre-treatment height velocity less than the mean for age and sex exclusion criteria: 1. clinically significant diseases 2. chronic illnesses 3. prior treatment with rhigf-1
the effect of intra-pulpal anesthesia with cryotherapy on intra-operative pain

Conditions: Irreversible Pulpitis

Summary: the goal of this clinical trial is to compare the effect of cooling of local anesthesia on intraoperative pain during root canal treatment in mandibular molars diagnosed as symptomatic irreversible pulpitis. the main question it aims to answer is: is there a difference in intra-operative pain levels using intra-pulpal anesthesia with and without cryotherapy during root canal treatment? participants will undergo root canal treatment using intrapulpal anesthesia with and without cooling. researchers will compare cold and room temperature intrapulpal anesthesia to see the intensity of intraoperative pain.

the study will be conducted on 40 mandibular molars in each group n = 20. the patient will be asked to pick an opaque sealed envelope that will contain a number 1 or 2. the resultant number will determine in which group the participants will be placed. double blinding will be maintained in this study as the assessor and the patients will not be aware of their group. group 1: will receive intrapulpal local anesthesia at 4-5 c after pulp exposure. group 2: will receive intrapulpal local anesthesia at room temperature after pulp exposure. procedural steps: 1. a history of present illness will be recorded from the patient and the suspected tooth will be tested for vitality using a cold test and an electric pulp tester, to ensure the correct diagnosis is reached. 2. once the diagnosis is confirmed to be symptomatic irreversible pulpitis, the patient will receive an inferior alveolar nerve block (2% lidocaine 1:100,000). 3. a rubber dam will be used to achieve isolation, and an access cavity will be prepared using a high-speed handpiece, a round bur (no.4), and an endo-z bur. 4. if the patient reports feeling any pain, the procedure will stop, and the patient will be presented with a visual analogue scale and asked to rate the pain on a scale of 1-10. pain levels of more than 5 will be included in the study. 5. intra-pulpal anesthesia (2% lidocaine 1:100,000) will be administered, and the needle will be surrounded by a piece of sterile gauze to ensure it is under back pressure. 6. after administering the intra-pulpal injection, the patient will again be presented with the same vas and asked to rate their current pain.

Eligibility criteria:
inclusion criteria: * patients with mandibular molars diagnosed with symptomatic irreversible pulpitis. * mandibular molars with closed apices. * patients who are experiencing pain during access cavity drilling above 5 visual analog scale. exclusion criteria: * • patients with a known allergy to lidocaine. * root canal-treated mandibular molars. * patients with systemic diseases. * mandibular molars with open apices. * mandibular molars with external/internal resorption. * non-restorable mandibular molars.
proyecto bebe: the effect of babywearing education on breastfeeding exclusivity

Conditions: Breastfeeding, Exclusive; Mother-Infant Interaction; Postpartum Depression

Summary: to test the hypothesis that increased mother-infant physical contact affects the likelihood of mothers exclusively breastfeeding their child for the first six months of life, the investigators will randomly assign half of the participating mothers to receive a baby carrier to use with their baby (to facilitate increased physical contact) while the other half of babies and mothers will receive standard care.

one hundred mothers participating in the california border healthy start (cbhs) program will be randomly assigned to the physical contact group or the control group. mothers in the physical contact group will be provided with an infant carrier to use from birth to facilitate increased mother-infant physical contact. in the control group, mothers will be provided with an infant carrier, but will not receive the carrier until postpartum week 24, once study measures have been collected. this type of multiple-baseline design will allow the investigators to objectively assess the effect of physical contact during the first six months, but will also ensure that mothers in both groups have the opportunity to benefit from the potentially positive intervention of a high quality infant carrier to promote increased mother-infant physical contact. the two groups will be compared on: 1) likelihood of exclusive breastfeeding, 2) extent of breastfeeding exclusivity (proportion of feeds that are breastmilk versus formula or other), 3) likelihood of initiating feeding in response to hunger cues versus crying (i.e., maternal responsiveness during feeding), 4) maternal score on the edinburgh postnatal depression scale (epds), 5) prevalence of breastfeeding difficulties, 6) score on the mother-infant bonding scale, and 7) beliefs about breastfeeding and infant care.

Eligibility criteria:
inclusion criteria: to be eligible to participate in this study, participants: * must be a current participant in the cbhs program * must be 18 years of age or older * must be currently pregnant * must be fluent in either spanish or english * must have consistent access to a smartphone with internet access (to fill out surveys and feeding logs) * must have a functioning email address must be willing to share certain personal information with the researchers exclusion criteria: * having a birth that does not result in a live, healthy, singleton infant.
vibration response imaging (vri) in dyspnea patients presenting to the ed

Conditions: Dyspnea

Summary: for the patient with acute dyspnea in the ed, early differentiation between chf and non-chf causes is essential for proper management. the capacity to triage patients quickly and accurately has a beneficial impact upon outcome, disposition, stratification and length of stay in the ed and required length of hospital admission. the ability to assess pulmonary status rapidly by quantitative regional vibration technology offers significant potential advantage for earlier diagnosis. the vri technique may provide a quick and accurate method of differentiating between dyspnea due to hf and dyspnea due to pulmonary causes; thereby improving management and outcomes.


Eligibility criteria:
inclusion criteria: * able and willing to provide informed consent; -\>40 years of age; * estimated body mass index \>19; * patient presented to the emergency department with a chief complaint of acute dyspnea. exclusion criteria: * patients with obvious trauma or acute anxiety as a cause of dyspnea; * patient has already received directed therapy in the ed and symptoms are remarkably improved; * physician concern regarding possible harm to patient caused by positioning or ambulating the patient for vri testing; * intubated or mechanically ventilated; * acute hemodynamic or ventilator instability requiring immediate resuscitation; * body habitus or skin condition that might prevent the placement of the sound sensors on the back (e.g. severe scoliosis, kyphosis, chest wall deformation, skin lesion on the back or compression fracture); * hirsutism.

Keywords: dyspnea copd chf asthma
pilot study of motor-cable-driven system for stroke wrist and forearm rehabilitation

Conditions: Stroke

Summary: the research purpose is to investigate the feasibility of using a motor-cable-driven system for wrist and forearm recovery of hemiplegic subjects suffered from stroke, where assistive force would be generated from cables connected to pulleys and electrical motors. the system may use emg signal to control the movements.


Eligibility criteria:
inclusion criteria: * sub-acute and chronic stroke patients (ischemic or hemorrhagic). * sufficient cognition to follow simple instructions as well as understand the content and purpose of the study. exclusion criteria: 1. patients with severe dysphasia (either expressive or comprehensive) with inadequate communication. 2. any additional medical or psychological condition affecting their ability to comply with the study protocol.
the effects of methadone and buprenorphine on fetal neurobehavior and infant neonatal abstinence syndrome - 1

Conditions: Opiate Dependence; Pregnancy

Summary: the purpose of this study is to evaluate the effects of drugs used by treatment providers on the fetuses and infants of opiate dependent women. the subjects in this study are women enrolled in a large, multi-site, double blind study that looks at the effects of methadone and buprenorphine treatment during pregnancy. this study will evaluate fetal and maternal biophysiologic data longitudinally during pregnancy to determine how these substances may affect fetal neurobehavior. additionally, infant neurobehavioral assessments and measurements of infant vagal tone will be collected to see how methadone and buprenorphine differentially affect the neonatal abstinence syndrome, or "withdrawal" in exposed neonates.

previous research by this group has found that methadone treatment during pregnancy directly impacts fetal neurophysiology independently of maternal physiology. buprenorphine is a new therapy for opiate dependent individuals, and its use during pregnancy is currently being evaluated. some research has shown that buprenorphine lessens the neonatal abstinence syndrome when compared to methadone. thirty methadone and 30 buprenorphine maintained women will be evaluated at 24, 28, 32 and 36 weeks gestation using a state-of-the-art computerized fetal actocardiograph and data analysis program to simultaneously evaluate fetal movement and heart rate and maternal physiologic parameters. investigators will be blinded to treatment group. longitudinal neurodevelopment of the fetuses in each group will be explored. the differential effects of methadone and buprenorphine on the neonatal abstinence syndrome will also be explored.

Eligibility criteria:
inclusion criteria: * generally healthy opiate dependent women * currently enrolled in the study "maternal opioid treatment, human experimental research study * uncomplicated singleton pregnancies exclusion criteria: * complications of pregnancy, including hiv, diabetes, polyhydramnios, hypertension, preterm labor or placenta previa * evidence of fetal malformation * significant maternal health problems, including hiv infection * significant maternal psychopathology that would preclude informed consent, including schizophrenia * alcohol dependency per dsm iv criteria

Keywords: buprenorphine methadone