Kornimate/medical-research-clean huggingface dataset:
randomized controlled trial of routine screening for ipv

Conditions: Quality of Life; Disability; Utilization of Health Care Services

Summary: this is a randomized controlled trial with three arms to establish the impact of screening and referral to services for women disclosing exposure to ipv.

approximately 2675 women\* will be enrolled and randomized to one of 3 arms. in the first arm, participants will be screened, and if disclosing ipv, will receive information on available resources in the community. in arms two and three, participants will not be screened, but one group will receive information on available resources in the community and the other will not. all three groups will be assessed for quality of life (sf-12;standardized and validated scale with 12 questions that measure overall health (1 item), physical functioning (2 items), role limitations due to physical health problems (4 items), bodily pain (1 item), energy/fatigue (1 item), social functioning (1 item), psychological distress (1 item), and well being (1 item) in the past 4 weeks; items are summed to form a physical health composite scale and a mental health composite scale; each scale is standardized to have a mean of 50 and a standard deviation of 10 for the u.s. population with a possible range from 0 to 100; higher scores represent a better health state); disability; and utilization of health care and ipv services at baseline and at a 12 month follow-up. a pilot study, also using a randomized controlled trial design, will establish the feasibility, acceptability, and impact on disclosure rates, use of referral resources, and potential harms of three screening and referral strategies. \*sample size calculation based n needed to detect a standardized effect size of 0.3 with an α=.05 (1-tailed)and ß=.20 if there's a 20% ipv (+) rate and 30% lost-to-follow-up rate.

Eligibility criteria:
inclusion criteria: * women attending obstetrics \& gynecology (ob-gyn), family planning, general medicine, family medicine or hiv/sexually transmitted disease (std) clinic exclusion criteria: * non-english speaking other than spanish speakers * accompanied by a child \>3 years of age without adequate provision for child care; * visually- or hearing-impaired women; * without access to a telephone; * severe mental impairment

Keywords: intimate partner violence domestic violence spouse abuse screening
gps project evaluation of the impact of the reorganization of work into a family medicine group on pharmacotherapy and support for the autonomy of seniors with major neurocognitive disorders

Conditions: Major Neurocognitive Disorder

Summary: the model of care tested in the gps project aims to optimize pharmacotherapy for seniors undergoing cognitive assessment or suffering from major neurocognitive disorder (mcnd) at home. the goal is to reduce polymedication, inappropriate medications and the treatment burden of seniors and to maintain their cognitive health, quality of life and autonomy. the intervention will include knowledge exchange sessions with nurses, pharmacists, and doctors in fmgs, and increased collaboration between these professionals and home care services teams. other goal is to increase the satisfaction of the seniors, their families, and the professionals involved in the gps project.

: the gps project is part of the desire to keep seniors with major neurocognitive disorder (mcnd) in their homes for as long as possible. medication can contribute to cognitive loss in seniors and affect their functional autonomy. the arrival of pharmacists in fmgs and the expansion of their practice is opening up new opportunities to promote interdisciplinary collaboration and optimize pharmacotherapy for seniors. during the project, a new model of care, called gps, is being tested with seniors. a group of seniors (approximately 200) will receive the new care team's new interventions in the fmgs in the "intervention" group. another group of seniors (about 200) will receive the usual care in other fmgs that will serve as a "control" group. by comparing the results of the two groups, it will be possible to evaluate the effects of new interventions. a period of 12 months will be allocated for the inclusion of seniors. the follow-up of each senior will be approximately 6 months.

Eligibility criteria:
inclusion criteria: * all seniors (65 years of age or older) undergoing cognitive evaluation or referred to a memory clinic or having been diagnosed with cognitive impairment within the last year or with mcnd and followed up at home and, * referred to the pharmacist, for the fmgs exposed * taking prescription medications exclusion criteria: * seniors in palliative care or * unable to answer questionnaires in french and without a caregiver.

Keywords: living lab major neurocognitive disorder polypharmacy health outcomes pharmacists home care family medicine groups deprescribing
study of proliferation and apoptosis in rectal cancer, predictive & prognostic biomarkers: histopathology and imaging

Conditions: Neoplasms; Colorectal Neoplasms; Rectal Diseases; Gastrointestinal Neoplasms

Summary: this study tests biopsy and tissue from patients who have been treated for primary rectal cancer at the royal marsden hospital between 2011 and 2013, who have an mrtrg score at post-chemoradiotherapy mri. it is a retrospective pilot study to determine the apoptotic and proliferative index count pre and post chemoradiotherapy.

the investigators hope to validate the apoptotic and proliferative index as a predictive response marker and lend support to mrtrg as a putative prognostic tool in the treatment pathway for rectal cancer patients. even though this is a retrospective study, the investigators hope that pre-treatment apoptotic and proliferative scores will correlate to post treatment response and mrtrg scores. in doing so, the investigators can predict how patients will respond to treatment from initial diagnostic biopsies and foresee a patients individual treatment plan.

Eligibility criteria:
inclusion criteria: * patients over 18 years of age. * patients with primary adenocarcinoma of the rectum (diagnosed on tissue biopsy and disease spread assessed on ct and mri). * tumours must be considered sufficiently high-risk to require pre-operative chemoradiotherapy followed by surgery. * patients must have had a pre- and post-treatment mri scan of the rectum and pelvis. * we must have access to stored tissue for each patient exclusion criteria: * no pre-operative radiotherapy * patients with synchronous tumours * patients under the age of 18 years

Keywords: imaging, magnetic resonance rectal cancer apoptosis proliferation cancer tissue study
two inodilators postsurgery in neonates

Conditions: Low Cardiac Output Syndrome

Summary: congenital heart defects are the most prevalent group of congenital malformations in newborns. surgery-related low cardiac output syndrome (lcos) could be one of the reason for the unfavourable outcome of this population. the early use of inodilators (inds), specifically milrinone (mr), is proposed to reduce afterload and increase inotropism. studies in the paediatric population appear to support a clinical usefulness of mr similar to that observed in adults. levosimendan (levo) is a novel class ind developed for the treatment of heart failure. experience with levo in paediatric patients is scarce. the purpose of this study was to systematically test the efficacy and safety of milrinone (mr) and levosimendan (levo) in newborns undergoing cardiovascular surgery with cardiopulmonary bypass (cpb). given the uncertainty about levo pharmacokinetics in neonates, the study was designed as a pilot, phase i feasibility study.

surgical repair is the primary therapy for congenital heart defects in the newborn. the neonatal cardiovascular system is at particular risk to develop the surgery-related low cardiac output syndrome (lcos), thus vasoactive agents are routinely used in the postoperative management. systematic research on the efficacy of these drugs is scarce in the newborn. as lcos pathophysiology joints impaired myocardial contractility and the peripheral effects of ischemia/reperfusion injury on the endothelium, early use of inodilators (ind) are strongly recommended to reduce afterload and improve contractility. this study aims to test the equivalence in dose-dependent hemodynamic effects of 2 ind, milrinone and levosimendan, used early without loading dose in the preoperative period to prevent lcos. by means of non-invasive technology the investigators will assess cardiac function (serial structural and functional echocardiography), the cerebral and peripheral perfusion and oxygenation (continuous near-infrared monitoring), cerebral function (continuous amplitude integrated eeg monitoring), will rule out cns acquired lesions (serial transfontanelar echo-doppler studies), and will follow up different biochemical markers of myocardial stress and apoptosis. pharmacokinetic studies will be also performed.

Eligibility criteria:
inclusion criteria: * newborns undergoing cardiovascular surgery who were in stable pre-operative haemodynamic condition * parental consent given exclusion criteria: * parental consent refused * inodilators contraindicated

Keywords: congenital heart disease
a study to assess the clinical outcomes of surgical phaco segmentation techniques in patients undergoing cataract surgery

Conditions: Cataract

Summary: the purpose of this research study is to evaluate the clinical outcomes of different cataract surgical techniques for lens fragmentation in subjects undergoing routine cataract surgery.


Eligibility criteria:
inclusion criteria: 1. able to understand study requirements, willing to follow study instructions and willing to return for required study follow-up visits as confirmed by provision of written informed consent. 2. subjects with a visually significant cataract scheduled to undergo cataract surgery 3. subjects \> 18 years of age 4. bcva at baseline not better than 20/40 5. grade 1+ cataracts exclusion criteria: 1. subjects not able to complete the informed consent form 2. subjects \< 18 years of age 3. polar cataracts 4. zonular instability
evaluation of the effect on glucose control and the safety and tolerability of ac2993 in patients with type 2 diabetes mellitus

Conditions: Diabetes Mellitus, Non-Insulin-Dependent

Summary: this is a multicenter, randomized, blinded, placebo-controlled, short-term, dose-response study to examine the effects on glucose control of ac2993 as compared to placebo in patients with type 2 diabetes. patients will be individuals with type 2 diabetes treated with metformin for at least 3 months prior to screening. patients whose diabetes management consists of diet and exercise will also be eligible for this study.


Eligibility criteria:
inclusion criteria: * subjects with type 2 diabetes * treated with diet and exercise alone or with metformin for at least 3 months prior to screening * bmi 27-45 kg/m\^2 * hba1c between 7.0 % and 8.0 % exclusion criteria: * treated with other oral anti-diabetic agents other than metformin within 3 months of screening * patients previously treated with ac2993 * patients presently treated with insulin

Keywords: diabetes mellitus, type 2
effects of therapeutic mobile game on anxiety

Conditions: Social Anxiety Disorder

Summary: participants with social anxiety disorder (sad) will use a digital therapeutic for 30 days, and will complete assessments measuring a broad range of anxiety and mood-related symptoms, with a focus on sad symptoms, and metrics of functional impairment during this time. after the treatment period, participants will be followed at 6 month and 12 month after the completion of the study.

this study aims to assess the feasibility and efficacy of the digital therapeutic abm-01 in adults ages 22-65 with sad. participants access abm-01 on their mobile smart phone and complete treatment over a period of 30 days. enrolled participants will be randomly assigned to one of two groups (experimental group and placebo control) and be assessed over five periods of time (baseline session, 30-day treatment phase, post-treatment session, 6-month follow up session, 12-month follow up session). participants will complete the 30-day treatment phase as well as the five assessments remotely. during the treatment period, participants complete assessments social anxiety and generalized anxiety symptoms, as well as safety and medication use questionnaires.

Eligibility criteria:
inclusion criteria: * adults 22-65 at the time of screening * meets dsm-5 diagnostic criteria for social anxiety disorder * access to and willingness to use computer equipment/smartphone compatible with the product platform over a functional network for the study duration. * currently residing in the united states exclusion criteria: * risk of suicide or has attempted suicide within 24 months of the screening visit * moderate to severe substance use disorder * current co-morbid psychiatric diagnosis including ptsd, schizophrenia, bipolar disorder i or ii, autism spectrum disorder, or borderline personality disorder * currently pregnant or planning to become pregnant during the treatment period
erector spinae plane block versus caudal epidural analgesia

Conditions: Surgical Pain

Summary: the goal of this clinical trial is to compare the analgesic effect and safety of erector spinae plane block vs caudal epidural block in paediatric population undergoing lower limb cancer surgery. the main questions it aims to answer are: * which of them has a superior analgesic effect. * which of them is more safe and has less complication rate. participants or their guardians should agree to share in the study (after full explanation of risks and benefits) to receive one of the previously mentioned regional blocks in conjunction with the classic balanced general anaesthesia.

this randomized parallel group clinical trial was carried out on 32 paediatric patients aged from 8 to 15 years old, both sexes, belonging to american society of anaesthesiologists ii physical status, cancer patient receiving chemotherapy undergoing unilateral lower limb cancer surgery. patients were divided into two equal groups: group a: patients received selective unilateral espb and group b: patients received ceb. both in conjunction with general anaesthesia. the primary outcomes were determining the postoperative time of first rescue analgesia and assessment of total postoperative morphine consumption using erector spinae block compared to ceb in the first 12 hours after surgery. the secondary outcomes were assessments of the pain severity intra- and post-operative parallel with recording any complication regarding drugs or procedures.

Eligibility criteria:
inclusion criteria: * asa ( american society of anaesthesiologists) ii (cancer patient receiving chemotherapy). * 8 - 15 years of age. * planned to undergo unilateral lower limb cancer surgery. exclusion criteria: * patients with coagulopathy with inr (international normalization ratio) \> 1.6 (e.g.: haemophilia, fibrinogen abnormalities and deficiency with concentration \< 60 %). * history of allergy to local anaesthetics or any of the additives. * patients refused to be included in the study or their guardians. * cns (central nervous system) pathology. * unstable cardiovascular disease. * local or systemic infection.
examination of the effectiveness of nasal irrigation techniques in infants with nasal congestion

Conditions: Upper Respiratory Tract Infection; Nasal Congestion and Inflammations

Summary: the research investigates the effects of high-volume and low-volume nasal irrigation techniques applied to relieve nasal congestion in infants with nasal congestion due to upper respiratory tract infections. the study examines the physiological parameters of infants who undergo nasal irrigation, crying duration, frequency of the procedure, and the baby's feeding patterns.

this study aims to investigate the effects of two different nasal irrigation techniques applied to relieve nasal congestion on infants' physiological parameters, crying duration, feeding habits, and the frequency of the procedure repetitions. a randomized controlled experimental study was conducted with 80 infants aged 1-12 months who presented at the pediatric emergency clinic with nasal congestion due to upper respiratory tract infection. in the study, the 1st group of infants received low-volume saline solution, while the 2nd group received high-volume saline solution for nasal irrigation. physiological parameters were measured before the procedure, immediately after the procedure, and 5 minutes after the procedure. procedure duration and baby's crying duration were recorded. subsequently, breastfeeding was initiated for the infants, and their physiological parameters were measured again during breastfeeding. parental satisfaction levels with the procedure were also assessed. finally, the frequency of the procedure repetitions was recorded.

Eligibility criteria:
inclusion criteria: * infants diagnosed with upper respiratory tract infection and recommended nasal cleaning with saline solution by a physician, * infants whose parents provided consent for their participation in the research, * term-born infants aged 1 month to 12 months, * breastfed infants, * infants without chronic illnesses, * conscious infants, exclusion criteria: * infants with congenital anomalies affecting the respiratory system (such as choanal atresia, etc.), * infants with allergic rhinitis, * infants who used antibiotics or corticosteroids before hospital admission, * infants with growth retardation, were excluded from the study.

Keywords: infants nasal irrigation nasal lavage feeding
assessment of the ocular microbiome in health and disease

Conditions: Microbial Colonization; Eye Diseases; Ophthalmopathy

Summary: the objective of this application is to illustrate the core constituents of the ocular surface microbiome, describe factors that promote colonization, and assess the ocular microbiome's role in the health of the anterior segment. we will conduct a prospective, observational cohort study, including a longitudinal analysis of the ocular microbiome in adults.

the microbiome is defined as a community of microbial organisms that reside in a specific host niche. there is a growing body of literature on the association between gut microbiome and disease entities such as inflammatory bowel disease, colon cancer and presumably an association that might influence response to treatment in some patients. recent data suggest the existence of a resident ocular microbiota that may play a protective role in corneal infections \[1-4\]. however, not much is known about the ocular microbiome and its association with disease or response to treatment. the national eye institute (nei) recently hosted a symposium to discuss challenges to characterize the ocular microbiome and its role in promoting or preventing ocular diseases. one of the major challenges discussed is the lack of a normative population- based database describing the ocular microbiome. in response the nei as part of the anterior segment initiative put out an rfa requesting proposals on methods of collection of biological samples and associated clinical data (e.g. demographic, residence, medications, allergies); processing of samples to extract analytes (e.g., dna, rna, protein, metabolites) and characterizing microorganisms in a low biomass niche, specifically the ocular surface using16s rrna marker gene, whole metagenome sequencing (wms), and metatranscriptomics approaches.

Eligibility criteria:
inclusion criteria: we will include subjects who meet all of the following criteria: * 18 years of age or older * provide informed consent * cohort a - normal eyes with no ocular disease * cohort b - primary open angle glaucoma/ocular hypertension defined as mild glaucoma which is well controlled with no more than one drop of prostaglandin use daily for the past 6 months * cohort c - non-infectious keratopathy not using any prescription medication (otc artificial tears are acceptable) * cohort d - dry amd (age related macular degeneration) * cohort e - wet amd * cohort f - diabetic retinopathy exclusion criteria: we will exclude subjects who meet all of the following criteria: * prior ocular disease either of the anterior or posterior segment * any medical comorbidities except well controlled dh and htn * unable to follow up with study procedures as described
effectiveness and safety study of tezepelumab in adults & adolescent participants with severe asthma in the united states

Conditions: Asthma

Summary: to asses effectiveness and safety of tezepelumab in adult and adolescent participants with severe asthma including several under-studied populations in the united states.

this is a multicenter, single-arm, open-label, post-authorization, phase 4 study to assess the effectiveness of tezepelumab in the united states (us) among a real-world population of adults and adolescent participants with asthma requiring medium-dose to high-dose inhaled corticosteroids (ics), with additional controller(s) for at least 12 months with documented history of at least 2 asthma exacerbations during the year prior to enrolment. the total duration of the study for each participant will be approximately 56 weeks. approximately 400 participants will be enrolled. participants will receive tezepelumab via subcutaneous injection at the study site, over a 48-week treatment period. the study also includes a post-dosing follow-up period from weeks 48 to 52.

Eligibility criteria:
inclusion criteria: * male or female participant must be 12 years of age or older, at the time of signing the informed consent form or assent. * documented physician-diagnosed asthma for at least 12 months prior to enrollment and confirmed by the investigator not to be due to alternative diagnoses. * documented treatment with medium- to high dose ics as per global initiative for asthma (gina) guidelines (gina 2021) for at least 12 months prior to enrollment. * use of additional asthma maintenance controller medication(s) in addition to ics for at least 12 months prior to enrollment. the additional maintenance controller medication may be contained in a combination product (eg, ics/ long-acting β-agonist (laba)). * documented history of at least 2 asthma exacerbations during the 12 months prior to enrollment. * physician decision that participant is eligible for treatment with tezepelumab according to the approved united states product insert (uspi). * currently receiving care from specialist physicians (eg, pulmonologists and/or allergists). * provision of signed and dated written informed consent form. exclusion criteria: * any contraindication to tezepelumab as per the us approved product label or in the opinion of the investigator. * comorbid diagnosis of severe or very severe chronic obstructive pulmonary disease (copd) per gold guidelines (gold 2021). * use of biologics that are approved for the treatment of asthma within 4 months or 5 half- lives (whichever is longer) prior to enrollment. * participation in an interventional clinical trial for asthma within 12 months prior to enrollment. * judgment by the investigator that the participant is unlikely to comply with study procedures, restrictions, and requirements.

Keywords: inhaled corticosteroids (ics) post-authorization baseline blood eosinophil count (bec) long-acting- β2 agonist (laba) real-world participant population