Kornimate/medical-research-clean huggingface dataset:
a study to investigate the safety and efficacy of kqb168 as monotherapy and in combination in participants with advanced solid malignancies

Conditions: Solid Tumor Malignancies

Summary: the goal of this clinical trial is to learn if kqb168 works to treat advanced solid tumor cancer in adults. it will also learn about the safety of kqb168. the main questions it aims to answer are: * what is the safe dose of kqb168 by itself or in combination with pembrolizumab? * does kqb168 alone or in combination with pembrolizumab decrease the size of the tumor? * what happens to kqb168 in the body? participants will: * take kqb168 daily, alone or in combination with pembrolizumab * visit the clinic about 8 times in the first 8 weeks, and then once every 3 weeks after that


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of solid tumor malignancy. * unresectable or metastatic disease that has progressed on immunotherapy. * no available treatment with curative intent * adequate organ function * measurable disease per recist v1.1 exclusion criteria: * active primary central nervous system tumors * cardiac abnormalities * history of lung diseases * any condition that may impair drug absorption or prevent oral dosing * known history of immune-mediated colitis and uncontrolled autoimmune diseases
laparoscopic cholecystectomy for acute calculous cholecystitis in the elderly: a retrospective study.

Conditions: Acute Cholecystitis

Summary: with the progressive aging of the population in industrialized countries, acute calculous cholecystitis (acc) has been constantly increasing among elderly. because acc is the most common complication of biliary gallstone disease and the population will become older, acc in elderly is expected to increase. in 2017, the incidence of gallstone disease in italian population is was 18.8% in women and 9.5% in men; the prevalence was 15% and 24% at 70 years and 24% and 35% at 90 years for males and females respectively. since the increase in age is often associated with an increase in comorbidity, fragility, surgery related complications, morbidity and mortality, the surgical indication for gallstone is still debated and often based on anesthetic risk. in order to avoid surgery for elderly and high-risk patients, alternative treatments to surgery have been developed. the present study aimed to compare two groups of patients with acute calculous cholecystitis undergone laparoscopic cholecystectomy, under and over 70 years old and to assess whether laparoscopy can offer the same safety and efficacy to older people.


Eligibility criteria:
inclusion criteria: * acute calculous cholecystitis exclusion criteria: * tumors of the biliary tract
a new measure of egg consumption and the effect of social marketing eggs

Conditions: Nutritional Stunting

Summary: about 1600 children 6 to 24 months old will be enrolled from 8 egg hubs. 4 hubs will be receive social marketing campaign to raise awareness about the benefits of eggs while the other 4 will not receive social marketing campaign. children will provide a urine sample for analysis of metabolites to correlate with egg consumption.


Eligibility criteria:
inclusion criteria: * health children between 6 and 24 months of age exclusion criteria: * acute malnutrition * congenital abnormalities * chronic debilitation disease such as heart disease, cerebral palsy, or hiv infection
effects of breaking up prolonged sitting on postprandial cardiometabolic disease risk markers in south asian adults

Conditions: Cardiovascular Risk Factor; Cardiovascular Diseases; Diabetes; Physical Activity; Sedentary Lifestyle

Summary: the purpose of this study is to examine whether breaking up prolonged sitting with short regular bouts of walking can reduce blood sugar and cholesterol levels after eating, which are risk markers for type 2 diabetes and heart disease. this study will compare these responses in normal weight versus overweight/obese south asian adults.

participants will attend a preliminary testing session where height, weight, body fat and waist circumference will be measured. they will be familiarised with a motorised treadmill that will be used during the experimental visit below and will take part in an exercise test to determine a light-intensity walking speed for the experimental visit. participants will then attend two experimental visits in a random order: 1. prolonged sitting: participants will remain seated for 5 hours and instructed to reduce excessive movement. 2. breaking up sitting with walking breaks: participants will rise from the seated position every 30 minutes throughout the experimental period to walk on a motorised treadmill at a light intensity for 3 minutes. after performing walking activity, they will return to the seated position. in addition, blood sample will be taken at the resting position just before each physical activity bout. the activity breaks will be undertaken on 9 occasions, providing a total of 27 min of light intensity activity. during each visit, blood pressure will be taken 11 times and blood samples will be taken 10 times. participants will be given a breakfast and lunch meal to consume.

Eligibility criteria:
inclusion criteria: * self-identified south asian ethnicity. * self-report sitting at least 7 hours per day. * normal weight, overweight or obese. exclusion criteria: * unable to speak and read english. * contraindications to performing light-intensity walking. * diagnosed cardiovascular disease or diabetes.
using the blood eosinophil count to guide systemic corticosteroid treatment in asthma exacerbations

Conditions: Asthma Attack; Asthma

Summary: asthma attacks which are moderate-to-severe are typically treated with corticosteroids, but the optimal treatment duration is unknown and treatment responses can be variable. inadequate treatment may compromise recovery, but increased exposure to corticosteroids is, in turn, associated with drug-related adverse effects. there is a need for a biomarker to guide duration of corticosteroid treatment in asthma attacks. one such candidate biomarker is the blood eosinophil count, which may predict steroid-responsiveness. we hypothesize that the blood eosinophil count can potentially be used as a biomarker to guide the duration of corticosteroids in moderate-to-severe asthma attacks. this study will recruit individuals hospitalized for asthma attack. participants will be randomized to standard care or blood-eosinophil guided systemic corticosteroid therapy. subjects in the standard arm will receive oral corticosteroids for a total of 5 days. subjects in the blood-eosinophil guided arm will receive oral corticosteroids for a total of 5 days if admission eosinophil count is ≥ 0.300 x 10\^3/µl, and receive 3 days of oral corticosteroids if the admission blood eosinophil is \< 0.300 x 10\^3/µl. the rate of treatment failure will be compared between these two groups.


Eligibility criteria:
inclusion criteria: 1. age ≥ 21 years old 2. admitted for acute exacerbation of asthma and have received ≤ 3 days of systemic corticosteroids 3. have a had a blood eosinophil count (as part of routine clinical care) drawn before administration of systemic corticosteroid 4. have not taken scs within 7 days prior to presentation to hospital exclusion criteria: 1. concomitant pneumonia 2. admission to high-dependency/intensive care unit, or requirement for invasive/noninvasive mechanical ventilation 3. eosinophilia due to other known causes (eosinophilic granulomatosis and polyangiitis, parasitic infections, malignancy) 4. other concomitant respiratory conditions e.g. chronic obstructive pulmonary disease, bronchiectasis 5. those on anti-il5 or anti-il5r treatment 6. pregnant subjects 7. subjects who are already on an investigational drug or has been participating in another clinical study with an investigational product within the last 6 months 8. subjects deemed by investigators to have a life expectancy of \< 12 months (any cause) 9. prisoners
hepatitis b virus (hbv) viral suppression by entecavir in adefovir partial responders

Conditions: Hepatitis B

Summary: we propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 48 weeks of entecavir following partial response to adefovir. the aim of the study is to describe sequential virologic response to adefovir and entecavir.

amendment was made, and approved by wirb in january 2009, to this protocol: we propose a largely retrospective study with short-term prospective follow-up in a subgroup of patients who have not yet been treated with 96 weeks of entecavir following adefovir treatment. the aim of the study is to describe sequential virologic response to adefovir and entecavir.

Eligibility criteria:
key inclusion criteria: * age 18 years or older * all genders and ethnicity * positive hbsag * hbeag positive and negative * pretreatment hbv dna of 10,000 copies/ml or higher (for purposes of this study, both copies and equivalent iu measurements will be recorded and analyzed) * patients who are switched to, or prescribed, entecavir after treatment with adefovir for at least 12 weeks by the providing physician. * patients with and without prior lamivudine exposure will be enrolled but enrollment of lamivudine experienced cases will be limited to no more than 30 patients total key exclusion criteria: * patients who refused to consent to the study * patients younger than 18 * vulnerable subjects such as pregnant women, prisoners, employees, patients with significant cognitive deficits. * patients with prior exposure to another nucleoside for more than 2 weeks. those with prior exposure to lamivudine will be enrolled under conditions detailed above. * hiv co-infection * hcv co-infection * hdv co-infection * recipients of solid organ transplantation * patients who receive high-dose steroid (60 mg/d or higher and for longer than 10 days)

Keywords: hepatitis b hbv treatment
exploring diroximel fumarate real-world experience in canada and israel

Conditions: Relapsing Forms of MS

Summary: the primary objective of the study is to characterize the persistence to therapy in participants with relapsing forms of multiple sclerosis (rms) treated with diroximel fumarate (drf) in routine clinical practice. the secondary objectives of the study are to assess short-term persistence to treatment; to assess long-term persistence on treatment; to assess the effect of drf on relapses; to assess the impact of drf on cognition; to assess the impact of drf on participant reported outcomes (pros); to assess the impact of drf on disability; to assess treatment satisfaction with drf; to explore the real-world safety profile of drf (i.e., gastrointestinal \[gi\] tolerability, lymphocyte dynamics, adverse events \[aes\] leading to discontinuation, and serious adverse events \[saes\].


Eligibility criteria:
key inclusion criteria: * have a diagnosis of ms and satisfy the approved therapeutic indication for drf per the prescribing information. * drf prescribed and planned to be initiated within 60 days of enrollment or already initiated, with enrollment occurring no more than 7 days since the first dose. key exclusion criteria: * history of gastric bypass or required use of feeding tubes. * current enrollment in any interventional study or in any study which may conflict with this study, per the discretion of the principal investigator (pi) and biogen * have received prior treatment with drf (more than 7 days before enrollment). note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: clinically isolated syndrome multiple sclerosis relapsing forms of multiple sclerosis active secondary progressive disease
parental attitudes to neoanus dilatations post-reconstruction in anorectal malformations

Conditions: Anorectal Malformations

Summary: the goal of this qualitative clinical trial is to learn about parental attitudes and experiences of performing post-operative dilatation anal dilatations for their child with an anorectal malformation. the main question it aims to answer are: 1. what are parental experiences/attitudes towards performing anal dilatations post-operatively. in the first part of the study, participants will take part in a small virtual focus group discussion to identify themes to aid design of a semi-structured interview for part 2. in part 2, participants will undergo a virtual semi-structured interview. the answers will be recorded, anonymised, transcribed and undergo thematic analysis.

babies born without an anal opening require reconstructive surgery to create one, allowing them to pass stools. after the procedure, some surgeons recommend that parents perform routine dilatation of the anal opening using a metal rod dilator called a hegar dilator. recent studies have shown no difference in clinical outcomes for patients who have routine anal dilatation and those who do not. this study will look to find out the parental experiences and attitudes towards performing anal dilatation for their child. the study will be formed of 2 parts. participants will all be parents who were asked to perform routine anal dilatation post-operatively for their child born with an anorectal malformation. in part 1, a focus group will be conducted via microsoft teams to ascertain themes to formulate the questions for part 2. in part 2, individual semi-structured interviews will be performed via ms teams. the interviews will be recorded, anonymised, transcribed and undergo analysis to assess for common themes. the results will be published to guide professionals with regards to best practice and help inform parental discussions for new patients.

Eligibility criteria:
inclusion criteria: the parent of any patient who has: * undergone a posterior sagittal anorectoplasty for anorectal malformation and been recommended post-operative anal dilatations * and operation performed prior to november 2020 * and able to understand and communicate in english * and with access to a mobile/computer with ms teams exclusion criteria: the parent of any patient who had has: * not undergone a posterior sagittal anorectoplasty for anorectal malformation * and/or, not been recommended post-operative anal dilatations * or operated on after to november 2020 * or unable to understand and communicate in english * or without access to a mobile/computer with access to ms teams
evaluation of the effect of an emergency department information video on the risk of post-traumatic stress disorder 30 days after an emergency visit.

Conditions: PTSD - Post Traumatic Stress Disorder; Stress Disorder, Post Traumatic

Summary: post-traumatic stress disorder (ptsd) is a psychological disorder characterized by the re-experiencing of distressing symptoms, avoidance of traumatic memories and physiological hyperarousal in people who have been exposed to a traumatic event. the consequences of ptsd are manifold: financial, quality of life, absenteeism, morbidity, and mortality. an emergency department visit can be a traumatic event and associated with anxiety. studies have explored the prevalence and factors associated with the occurrence of ptsd among a selected population of patients admitted to the emergency department for either cardiological or traumatological reasons. the prevalence of ptsd at 1 month varied among these populations, from 12% to 25%. several factors have been described that could be independently associated with an increased risk of developing ptsd: factors linked to the patient himself (basal state and severity of acute pathology) or to the patient pathway (care structure, care modalities, waiting time). given the serious medical, psycho-social and economic consequences of ptsd, it is important to identify the risk factors that can be controlled during a patient's stay in the emergency department. in 2025, a general information procedure for patients and next of kin will be deployed in three emergency departments. the aim of this procedure is to improve the quality of the information provided to emergency patients, thereby enhancing the experience of patients and those accompanying them. it will consist of video support delivering standardized information to patients from the moment they arrive in the emergency department until they are discharged. these videos will describe the patient's journey through the emergency department. the aim of this study is to evaluate the effect of this information procedure on the risk of developing ptsd.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years * triage level 1, 2, 3 by the triage nurse (according to cimu, french or other scale used locally) * non-opposition to participation in the study after information and delivery of the information note * possibility of 30-day follow-up (self-questionnaire to be completed by e-mail) * patient with cognitive or sensory capacity to view and understand information videos exclusion criteria : * inability to consent (neurological disorder, coma, acute intoxication, cognitive impairment) * patient does not have a good understanding of the french language. * estimated life expectancy less than 6 months * participation in other clinical intervention research

Keywords: stress disorders interventions communication emergency medicine
dose-escalation study of single dose ghb04l1 in healthy adults

Conditions: Influenza

Summary: it is the hypothesis of this study that intranasal vaccination with a single dose of ghb04l1 is safe and induces an immune response against influenza a h5n1. this hypothesis will be tested in a randomized, double-blind, placebo-controlled, phase i dose-escalation study assessing the safety and tolerability of single dose administration of ghb04l1 in healthy adults. furthermore, the local and systemic immune response as well as the pharmacokinetic properties of a single dose of ghb04l1 will be studied as secondary objectives. ghb04l1 will be escalated according to a fixed dose escalation scheme comprising three dose levels.


Eligibility criteria:
inclusion criteria: * healthy male volunteers, 18-50 years * seronegative for h5n1 * seronegative for h1n1 (with antibody titers ≤1:20) * written informed consent to participate in this study exclusion criteria: * acute febrile illness * signs of acute or chronic upper or lower tract respiratory illnesses * history of severe atopy * seasonal influenza vaccination from 2006/2007 onwards and/or pandemic influenza vaccination against h5n1 * known increased tendency of nose bleeding * volunteers with clinically relevant abnormal paranasal anatomy * volunteers with clinically relevant abnormal laboratory values * simultaneous treatment with immunosuppressive drugs * clinically relevant history of renal, hepatic, gi, cardiovascular,haematological, skin, endocrine, neurological or immunological diseases * history of leukaemia or cancer * hiv or hepatitis b or c seropositivity * volunteers who underwent rhino or sinus surgery, or surgery of another traumatic injury of the nose within 30 days prior to application of study medication * volunteers who have received antiviral drugs, treatment with immunoglobulins or blood transfusions, or an investigational drug within four weeks prior to study medication application * volunteers who have received anti-inflammatory drugs 2 days prior to study medication application * volunteers who are not likely to cope with the requirements of the study or with a significant physical or mental condition that may interfere with the completion of the study

Keywords: vaccination avian
foot bath on fever management in children (ewwfbfmc)

Conditions: Nursing Caries

Summary: reducing the dependency on medication in lowering fever, which is one of the most common symptoms in childhood, and developing safer and more feasible alternative methods are important for child health. this study is planned to evaluate the effect of warm water foot baths on vital signs and pain in children and to scientifically examine this effect with a randomized controlled trial.

fever is one of the most common symptoms in childhood, especially in children under the age of five. while it is the most frequent reason for visits to health institutions, it constitutes 25% of pediatric emergency visits. lack of knowledge about fever in parents triggers fear, and the thought that it can cause seizures, disability, and brain damage induces anxiety and panic in many families. in the presence of anxiety and panic, families may quickly resort to early and incorrect treatment. administering less medication than necessary for low fever or high doses for high fever, repeated use of antipyretics, and inappropriate use of antibiotics lead to ineffective management, causing an increase in repeated emergency visits and unnecessary crowding in emergency services. published guidelines on high fever have emphasized focusing on pain and comfort rather than reducing fever in children. it is reported that foot baths, preferred in pain management, effectively reduce pain and increase comfort. additionally, guidelines related to fever highlight that warm applications after medication administration can effectively lower persistent fever. warm water foot bath therapy dilates blood vessels, increases blood circulation, releases heat as sweat, and supports increased oxygenation. increased circulation improves tissue nutrition and reduces stress. in a study by ishita et al. (2017), it was observed that body temperature decreased in children who had a warm water foot bath. similarly, studies by sunar (2017) and retnam and sophia (2018) reported that warm water foot baths were effective in reducing fever in individuals with complaints of high fever.

Eligibility criteria:
inclusion criteria: * the child is between 1-5 years old. the child has presented to the emergency department with a fever of 38.3°c or higher. the child is a patient with "yeşil alan" (specific condition or disease). the child has no chronic illness. the child has not used any other antipyretic medication in the last 6 hours. the child has been administered 15 mg/kg of oral paracetamol as prescribed by the doctor. the child and their parent(s) have volunteered to participate in the study. written consent from the parent(s) is obtained. exclusion criteria: individuals who have not agreed to participate voluntarily in the study. children who have been unable to take paracetamol due to spillage or vomiting. children with compromised skin integrity. individuals who have undergone surgical procedures that would hinder the child's activity. -