Kornimate/medical-research-clean huggingface dataset:
open-label extension and safety study for participants with crohn's disease previously enrolled in the etrolizumab phase iii study ga29144

Conditions: Crohn Disease

Summary: this open-label extension and safety monitoring study is composed of two parts: part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active crohn's disease who were previously enrolled in the etrolizumab phase iii study ga29144 (nct02394028) and who meet eligibility criteria for enrollment into part 1. in part 2, participants who have stopped etrolizumab treatment (either by exiting part 1 of this study or by entering directly from study ga29144 \[nct02394028\]) will be monitored for 92 weeks for progressive multifocal leukoencephalopathy (pml) and other safety events.


Eligibility criteria:
inclusion criteria: part 1 open-label extension: * patients previously enrolled in etrolizumab phase iii study ga29144 (nct02394028) who meet the eligibility criteria for open-label etrolizumab as described in the protocol part 2 safety monitoring: * patients who participated in etrolizumab phase iii study ga29144 (nct02394028) and are not eligible or choose not to enter part 1 * patients who transfer from part 1 * completion of the 12-week safety follow-up period prior to entering exclusion criteria: part 1 open-label extension: * any new, significant, uncontrolled condition part 2 safety monitoring: * no exclusion criteria
cequa for sjogren's syndrome dry eye

Conditions: Dry Eye; Dry Eye Syndromes; Sjogren's Syndrome

Summary: the primary objective of this study is to show that cequa (cyclosporine 0.09% ophthalmic solution) improves symptoms of dry eye disease in a population of patients with sjogren's syndrome diagnosis.

after being informed about the study and potential risks, all participants giving informed consent will have an eye exam and will be asked about their medical history to determine eligibility for the study. eligible participants will continue to the second visit the same day or up to 10 days later. during the second visit participants will answer questionnaires about their eyes and have their vision, eyes, and tears examined. all participants will be given cequa to use over the duration of the study. the same procedures will be repeated every four weeks for 3 months total.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of sjogren's syndrome. * self-reported complaints of ocular dryness for a period of at least 3 months * best-corrected distance visual acuity of 20/25 or better in each eye. exclusion criteria: * use of cyclosporine within the last 3 months. * use of ocular steroid within the 3 months. * previous history of treatment failure with cyclosporine. * known hypersensitivity or contraindication to the study medication or any of its ingredients. * use of any systemic or topical ocular medication that is known to cause or exacerbate dry eye. * any active ocular infection. * severe or serious ocular condition in either eye or any other unstable medical condition that may preclude study treatment or follow-up. * history or presence of chronic generalized systemic disease that might increase the risk to the subject or confound the results of the study. * currently pregnant or lactating.
a comparative study between amlodipine 10mg and 5mg with hypertension for whom 5mg is insufficient

Conditions: Hypertension

Summary: the changes in the trough systolic blood pressure from the baseline were assessed after 8 weeks of double-blind treatment with amlodipine 10 mg or amlodipine 5 mg


Eligibility criteria:
inclusion criteria: * untreated hypertensive patients: an systolic blood pressure of \>=160 mmhg or diastolic blood pressure \>=100mmhg. * treated hypertensive patients: an systolic blood pressure of \>=140 mmhg or diastolic blood pressure of \>= 90 mmhg. * patients with insufficient response to 5 mg of amlodipine in the screening period:two successive systolic blood pressure measurements at visit 4 (week -2) and visit 5 (week 0 = baseline) \>=140 mmhg * patients with a screening treatment compliance rate \>= 80% exclusion criteria: * subjects with secondary hypertension (renal disease, pheochromocytoma, and cushing's syndrome, etc.), severe hypertension (systolic blood pressure of 180 mmhg or higher, or diastolic blood pressure of 110 mmhg or higher), and malignant hypertension
correlating in vitro fertilization outcomes after euploid blastocyst transfer with sperm dna fragmentation

Conditions: Male Infertility

Summary: the purpose of this study is to determine if sperm dna fragmentation is associated with in vitro fertilization (ivf) outcomes when euploid embryos are transferred.

the purpose of this study is to determine if sperm dna fragmentation is associated with in vitro fertilization (ivf) outcomes when euploid embryos are transferred. euploid embryos are those that have a complete set of chromosomes (46, xx or 46, xy). sperm dna fragmentation refers to sperm dna that is damaged or has an altered structure. the sperm chromatin structure assay (scsa) is a method to evaluate sperm dna fragmentation. couples will undergo a routine ivf cycle at reproductive medicine associates of new jersey. semen specimens collected on the day of icsi will undergo semen analysis as per routine. an aliquot of semen (0.5- 1ml) will be collected for subsequent evaluation of dna fragmentation by the sperm chromatin structure assay (scsa) testing at scsa diagnostics. all embryo biopsies will undergo ccs analysis in the genomics laboratory, foundation for assessment and enhancement of embryonic competence.

Eligibility criteria:
inclusion criteria: * completing first ivf/icsi cycle at reproductive medicine associates of new jersey * couple undergoing ccs (comprehensive chromosome screening) * female age 35-40 years * male will have to refrain from ejaculation no less than 2 days but no greater than 5 days prior semen specimen production on day of oocyte retrieval exclusion criteria: * known genetic abnormality * use of sperm donation or cryopreserved sperm * use of oocyte donation * use of gestational carrier * use of testicular aspiration or biopsy procedures to obtain sperm * presence of varicosele * presence of hydrosalpinges that communicate with endometrial cavity * any contradictions to undergoing in vitro fertilization or gonadotropin stimulation

Keywords: male infertility sperm dna fragmentation sperm abnormality
effect of cold atmospheric plasma on malassezia folliculitis

Conditions: Malassezia Folliculitis

Summary: the cold atmospheric plasma may provide a new and effective method for the treatment of malassezia folliculitis. the investigators conduct this randomized controlled trial to evaluate the effectiveness and safety of cold atmospheric plasma on malassezia folliculitis. participants entered this double-blind placebo-controlled trial will randomly assign to treatment with either cold atmospheric plasma or antifungal drugs. the differences of treatment effects of the two groups will be observed and compared.

malassezia folliculitis is a common disease of young and middle-aged people. it is an inflammatory disease caused by malassezia infection. generally, topical or systemic use of antifungal drugs are the first choice for treatment but sometimes are limited due to adverse drug reactions and drug resistance. cold atmospheric plasma has an inhibitory or killing effect on pathogenic microorganisms including fungi and has no obvious adverse damage to normal tissues. the investigators conduct this randomized controlled trial to study the effect of cold atmospheric plasma on malassezia folliculitis, and evaluate its effectiveness and safety for malassezia folliculitis. all data are recorded and compared after the end of the experiment.

Eligibility criteria:
inclusion criteria: * patients are clinical presentation of malassezia folliculitis in seborrheic areas. * the diagnoses are mycologically verified by experienced laboratory technicians. * participants must be informed of the investigational nature of this study and be willing to provide written informed consent. exclusion criteria: * combined with other serious systemic diseases. * history of topical corticosteroids within 2 weeks or history of systemic corticosteroids within 1 month. * history of immunosuppressive drugs within 1 month. * history of topical antifungal medication within 2 weeks or systemic antifungal medication within 3 months. * pregnant and lactating women.

Keywords: malassezia malassezia folliculitis cold atmospheric plasma pityrosporum folliculitis
latin america registry on watchmantm outcomes in real life

Conditions: Atrial Fibrillation

Summary: left atrial appendage (laa) occlusion with watchmantm has emerged as viable alternative to anticoagulation therapy in randomized controlled trials. the device has fda approved since 2015 and the firsts latin american cases were performed in 2012. however, there is no real world data from latin american experience in terms of success and outcomes.

approximately 450 subjects will be enrolled in the study. up to 50 sites in latin america will participate in the study. primary analyses may include, but will not be limited to, the following: procedural complications, incidence of stroke and death. descriptive statistics will be used for baseline, procedure and follow-up data collected through the registry. clinical history of each patient will be analyzed for a period of 6 months after the procedure according the standard practice at the enrolling centers. there will be no additional visits, nor procedures, for subjects in the registry.

Eligibility criteria:
inclusion criteria: * patients who were eligible for a watchmantm device implantation according to current international and local guidelines and per physician and institution discretion. exclusion criteria: * patient who were currently enrolled in another investigational study or registry that would directly interfere with the current study aims.

Keywords: atrial fibrillation left atrial appendage stroke
preventing childbirth-related ptsd with expressive writing

Conditions: PTSD (Childbirth-Related)

Summary: the goal of this clinical trial is to test a brief psychological intervention given to individuals in the first days following childbirth who have experienced a potentially stressful childbirth. the treatment is aimed at preventing post-traumatic stress disorder following childbirth and promoting maternal-infant bonding. in the days following childbirth, participants will be asked to write about their childbirth experience or a neutral event for three consecutive days, for around 15 minutes each day. additionally, they will complete a short survey before and after the intervention about their birth experience and mental health. around 2 months postpartum, participants will take part in mental health and physiological assessments, and in a brief play session with their infant.

childbirth-related ptsd (cb-ptsd) is a debilitating maternal mental disorder that undermines the well-being of mothers and can interfere with bonding with their infants during an important time of infant development. a significant portion of delivering women, particularly those who have experienced complicated deliveries, are at-risk for developing cb-ptsd. underrepresented minorities are also at higher risk for cb-ptsd. an estimated 240,000 american women are likely to be affected by cb-ptsd each year. currently, there is no recommended intervention for individuals exposed to traumatic childbirth in hospitals in the united states. immediate postpartum interventions delivered to at-risk women that are low-cost, low-burden, and feasible are lacking. this study will attempt to fill this gap in effective treatment. evidence shows that expressive writing (ew), or briefly disclosing in writing mainly thoughts and feelings about a highly stressful event, can have positive effects on mental and physical health. therefore, the investigators will test the therapeutic effects of ew about recent childbirth in women at-risk for cb-ptsd.

Eligibility criteria:
inclusion criteria: * women who recently delivered at massachusetts general hospital (mgh). * women who are at risk for developing cb-ptsd based on their scoring of \>16 on the peritraumatic distress inventory (pdi). exclusion criteria: * age \ 50. * preterm delivery (\<37 week gestation) or stillbirth. * down's syndrome, other serious genetic disorder in the newborn, or serious birth defect (e.g., microcephaly, spina bifida). * admission to the neonatal intensive care unit (nicu) for more than 24 hours. * current diagnosable dsm-5 psychotic or bipolar disorder, or current substance abuse disorder. * active suicidality (assessed case by case). * present substance abuse as indicated in medical records. * severe maternal morbidity (assessed case by case). * general anesthesia. * inability to understand the study procedures, risks, and side effects, or to otherwise give informed consent for participation due to neurological or other reasons. * inability to understand english.

Keywords: mother-infant bonding postpartum depression postpartum ptsd expressive writing
effects of early behavioral and transaction interventions on preterm infants' and parents' biopsychosocial well-being

Conditions: Early Interventions; Preterm Infants; Parent-Child Relations

Summary: this randomized controlled trial will use a longitudinal repeated-measures design to examine the effects of two interventions, behavioral support interventions and a parent-infant transactional program, on parents' stress, ppd and sleep quality, parent-infant interactions, and their preterm infants' stress (saliva cortisol levels), sleep patterns, emotional regulation, and neurobehavioral developmental outcomes from 7 days to 2 years corrected age.

the proposed study has five specific aims: 1. to develop behavioral-support interventions for preterm infants who receive painful, stressful procedures in the nicu, 2. to develop a parent-infant transactional program (pitp) for parent-infant dyads with preterm infants in the nicu, 3. to determine the short-term effects of the behavioral-support interventions and pitp on infant stress (salivary cortisol levels) and sleep patterns, 4. to determine the short-term effects of the pitp on parental stress, depression, social support, and sleep quality during postpartum, and 5. to determine the long-term effects of the behavioral-support interventions and pitp on parent-infant interactions and infants' long-term emotional regulation and neurobehavioral outcomes.

Eligibility criteria:
inclusion criteria: 1. gestational age (ga) \> 28 weeks and \< 37 weeks 2. postbirth age \>2 days 3. stable condition (score\<20 on the neonatal therapeutic intervention scoring system \[ntiss\] for disease severity). 4. parents are not diagnosed with mental illness or some other illness known to influence/confound the outcome variables 5. parents are fluent in chinese 6. parents do not use drugs 7. parents agree to participate in this study exclusion criteria: 1. congenital anomalies 2. neurologic impairment including convulsion, intraventricular hemorrhage \> grade ii or periventricular leukomalacia 3. documented congenital or nosocomial (infection acquired at hospital after birth) sepsis 4. surgery 5. severe medical conditions requiring treatments such as cortisol supplementation, sedatives, muscle relaxants, antiepileptic, or analgesic drugs

Keywords: behavioral and transaction interventions parents' biopsychosocial well-being preterm infants sleep salivary cortisol
plasma neurofilament light and its relationship with omega-3 status and soccer heading in women soccer players

Conditions: Brain Trauma

Summary: the purpose of this study is to (1) assess how a competitive season of purposeful gameplay soccer heading in collegiate women soccer players is related to a blood biomarker for sports-related brain injury, plasma neurofilament light (nf-l), and (2) examine how a player's omega-3 status is related to plasma nf-l concentration changes during and after a competitive season of gameplay soccer heading.


Eligibility criteria:
inclusion criteria: * at least 18 years of age. * active player on the university's current team roster for the upcoming competitive season. * is eligible to participate in games and is not redshirting. exclusion criteria: * is recovering from a physician diagnosed concussion. * is recovering from another injury prohibiting the study participant from participating in all sport-related activities.

Keywords: soccer, heading, omega-3, neurofilament light, subconcussive, women
budesonide nasal irrigation versus fluticasone propionate nasal spray in treating allergic rhinitis patients

Conditions: Nasal Allergy

Summary: budesonide is a medication of the corticosteroid type. available as an inhaler, nebulization solution, the inhaled form is used in the long-term management of asthma and chronic obstructive pulmonary disease is used for allergic rhinitis and nasal polyps fluticasone propionate

the current study aims to compare between results of budesonid nasal irrigation and fluticasone nasal spray in the treatment of adult patients with allergic rhinitis.

Eligibility criteria:
inclusion criteria: * adult age between 18 and 60 years old. * patients with allergic rhinitis evidence by past skin prick testing. patients were given a skin prick test with a panel of dog, cat, dermatophagoides farinae, d pteronyssinus, alternaria, penicillium, hormodendron, aspergillus, grass pollen mix, tree pollen mix, and ragweed allergen extracts (100,000 allergen unit/ml). histamine, 10 mg/ml, was used as a positive control, and the diluent was used as the negative control. a positive reaction was defined as a wheal diameter at least 3 mm greater than the diluent control and/or at least a 50-mm flare (ie, erythema measured as the sum of the greatest diameter and the perpendicular diameter through the midpoint of the greatest diameter) exclusion criteria: * patients who had autoimmune diseases or any immune compromised diseases including diabetes, chemotherapy. * patients with a history of nasal surgery. * patients who received systemic or topical corticosteroids, herbal drugs, beta blocking agent within the previous month of enrolment. * patients with asthma and copd, nasal bleeding, obstructing nasal polyps, paranasal sinus.

Keywords: allergic rhinitis budesonide luticasone propionate
patient self-management and gene guided therapy for chronic hepatitis c

Conditions: Chronic Hepatitis C

Summary: this study will explore ways to improve the effectiveness of patient self management at a time when genetic test results guide new treatments that will dramatically increase the possibility of cure of the hepatitis c virus.the study will also focus on the interactions between provider and patients and the ways that technical work, adaptive work and adaptive leadership foster patient self-management.this proposed 2 year exploratory mixed-methods 12 longitudinal case study will explore patients' and providers' explanations for how and why they engage in technical work, adaptive work, and adaptive leadership and the ways in which these strategies promote or pose barriers to patients' self-management of chronic hepatitis c in the context of the new genetic test results and treatments. specific aims are to: 1: examine how technical work, adaptive work and adaptive leadership influence patients' perceptions of their likelihood of cure and how this work relates to self-management during 12 to 24 weeks of treatment for chronic hepatitis c. research questions are: 1.1) how do patients describe their interactions with the providers? 1.2) how do these interactions shape patients' perceptions of the likelihood of cure? 1.3) how do patients' understanding of their interactions with the provider promote the use of or pose barriers to self-management during treatment? aim 2: describe providers' use of technical work, and adaptive leadership approaches during clinical encounters,to include nurse education visits. research questions are: 2.1) what technical work, and adaptive leadership approaches do providers use when sharing treatment information with patients during the clinical encounters. 2.2) what explanations do providers give for how and why they use technical work and adaptive leadership approaches? aim 3: describe the trajectories of illness perceptions(control/cure sub-scale - illness perception scale), symptoms (m.d. anderson symptom inventory) , viral load, and self-management (patient activation measure) in relation to patient and provider reports of technical work, adaptive work, and adaptive leadership from the index clinical encounter to the follow-up treatment response encounter (ranging from 12 to 24 weeks).


Eligibility criteria:
inclusion criteria: * african american or caucasian * genotype 1 * planning to, but have not yet, began treatment for hepatitis c at duke university medical center or boice-willis clinic in rocky mount, nc exclusion criteria: * diagnosed with bipolar disorder or schizophrenia * not genotype 1 * any race other than african american or caucasian. * hispanic or latino

Keywords: chronic hepatitis c
mhealth to help pregnant and postpartum women in recovery for opioid use disorder

Conditions: Opioid Use Disorders

Summary: the opioid epidemic has resulted in widespread detrimental consequences among vulnerable populations in missouri, especially among pregnant and postpartum women (ppw) with opioid use disorder (oud). perinatal use of medication-assisted treatment (mat) within a comprehensive treatment plan is the current standard of care, however ppw struggling with oud may underestimate or misjudge its benefits. at the same time, emerging findings signal that mobile health (mhealth) technologies have the potential to support healthier behaviors among individuals with oud. in this project, we will test the utility of a theoretically-based digital therapeutics tool (umat-r) to encourage mat adherence and treatment retention while considering the unique needs of ppw. in aim #1, we will conduct four focus groups with ppw with oud (target users) on the intervention components of umat-r, gathering feedback on theory-driven components that are candidates for inclusion in the tool and eliciting suggestions for additional intervention components. in aim #2, the tool will be beta-tested for technical/navigational issues among 20 participants. in aim #3, we will conduct a pilot randomized controlled trial (rct) among adult ppw with oud (n=60). this rct is designed to test the feasibility, acceptability, and preliminary efficacy of umat-r (n=40) versus a control group (n=20 who receive treatment-as-usual) regarding participants' treatment adherence, sobriety, and improved mat attitudes, norms, and perceived control. recruitment for all aims will occur at a clinic in st. louis, missouri that provides perinatal medication-assisted treatment (mat) and high-risk maternity care to ppw struggling with oud. clinically meaningful effect size and attrition estimates will aid in the planning of a larger rct in which we will test umat-r on a larger scale and expand our recruitment to other clinics across missouri and other states. this novel technology could be an invaluable tool to assist physicians in the treatment of oud among ppw.


Eligibility criteria:
inclusion criteria: 1. pregnant or up to 1 year postpartum 2. receiving treatment at care 3. adult (≥18 years of age) 4. u.s. resident 5. currently on mat 6. fluent in english 7. women with opioid use disorder (oud) exclusion criteria: 8. currently incarcerated 9. patients with acute suicidality or psychotic disorders as assessed by care providers

Keywords: addiction mhealth women substance use disorder intervention