Kornimate/medical-research-clean huggingface dataset:
dose ranging study in elective total hip replacement surgery

Conditions: Venous Thromboembolism

Summary: the primary objective is to: * demonstrate the efficacy of sr123781a in the prevention of venous thromboembolism (vte) by the demonstration of a dose-response in patients undergoing total hip replacement surgery. the secondary objectives are to: * evaluate the safety of sr123781a in the prevention of vte after elective total hip replacement surgery; and * to assess the sr123781a pharmacokinetic profile in patients undergoing elective total hip replacement surgery.


Eligibility criteria:
inclusion criteria: * patients scheduled to undergo elective total hip replacement surgery or a revision of at least one component of a total hip replacement performed \> 6 months prior to study entry exclusion criteria: * pregnant or nursing women, or women of childbearing potential who are not using an effective contraceptive method and who do not have a negative pregnancy test performed immediately before randomization * known progressive malignant disease * ischemic stroke in the last 3 months * myocardial infarction (mi) in the last 3 months * any major orthopedic surgery in the 3 months prior to study start * clinical signs or symptoms of dvt or pe within the last 12 months or symptoms of post phlebitic syndrome (these conditions may confound dvt/pe assessments) * treatment with other antithrombotic agents within 7 days prior to surgery

Keywords: venous thromboembolism prevention arthroplasty replacement hip orthopedic surgery
feasibility and effectiveness of tdcs in the treatment of post-stroke fatigue (efects).

Conditions: Stroke

Summary: this study aims to analyze the use of non-invasive brain stimulation (tdcs) is beneficial for the treatment of post-stroke fatigue.

a single-blind randomized clinical trial will be conducted. the intervention will consist of 8 20-minute tdcs sessions conducted over four weeks. the stimulation will be performed by applying the stimulation to the dorsolateral prefrontal cortex on the left side (f3) and the cathode will be at point o2 of the right hemisphere. the study will consist of two groups: the control group in which sham stimulation will be applied and therapeutic education and aerobic exercise; the intervention group in which stimulation, therapeutic education and therapeutic exercise will be carried out.

Eligibility criteria:
inclusion criteria: * first stroke within 45 (+-7) days of the ischemic or hemorrhagic episode. * ability to understand and execute simple instructions * over 18 years. * fatigue scale of fatigue severity with a score greater than or equal to 24 exclusion criteria: * a score \> 2 on the modified rankin scale (mrs) before the stroke. * patients with decompensated cardiorespiratory and/or psychiatric pathology. * comorbidity causing disproportionate fatigue, such as long-term covid. * patients who are cancer survivors or who are undergoing cancer treatment. * patients with a history of epilepsy or who are taking antiepileptic medication. * patents with major depression.

Keywords: tdcs post stroke fatigue
intestinal permeability in children/adolescents with functional dyspepsia

Conditions: Functional Dyspepsia

Summary: the main purpose of this study is to evaluate whether intestinal permeability and/or serum zonulin concentration is increased in children/adolescents with functional dyspepsia (fd). the study will also explore the relationships between intestinal permeability, mucosal inflammation and anxiety in fd patients.

recurrent abdominal pain is a common complaint among school-age children, being present in up to 15% at any given time. it represents the most common chronic pain entity in pediatric patients. the great majority of these patients will have a functional gastrointestinal disorder (fgid). the most common fgid in these patients is functional dyspepsia (fd), defined as upper abdominal pain or discomfort unrelieved by bowel movement and in the absence of a structural or biochemical explanation for the pain. the etiology of fd is multifactorial, including biological factors, and these factors can be viewed within a biopsychosocial model. biological factors include inflammation, dysmotility and increased visceral sensitivity. these biological factors are influenced by and are interactive with psychosocial factors such as anxiety, depression and social interaction. this study will evaluate intestinal permeability as a measure of barrier dysfunction and investigate the correlations between increased permeability, mucosal inflammation and anxiety scores to provide further insight into the etiology of fd, thereby assisting in the development and selection of treatment modalities.

Eligibility criteria:
inclusion criteria: * abdominal pain of at least 8 weeks duration and fulfilling rome ii symptom based criteria for functional dyspepsia (patient group only); * undergoing endoscopy to evaluate fd following demonstration of a lack of clinical response to standard acid reduction therapy (patient group only); and, * informed permission/assent exclusion criteria: * previous abdominal surgery; * any chronic non-gastrointestinal illness requiring regular medical care (e.g. diabetes mellitus, juvenile rheumatoid arthritis, cystic fibrosis, cancer); * any history of an adverse reaction to lactulose or mannitol; * any use of antacids or laxatives within 1 week prior to the study; * any use of steroids, antihistamines or antihistamine-like drugs within 4 weeks prior to the study; * any use of aspirin is prohibited within one week prior to the study; * any use of non-steroidal anti-inflammatory drugs (nsaids) other than aspirin is restricted within one week prior to the study or at the discretion of the study physician; * any use of antibiotics including neomycin (mycifradin) within 4 weeks prior to the study; * pregnancy; * any current or chronic history within the previous 6 months of gastrointestinal symptoms including abdominal pain or discomfort, nausea, vomiting, bloating, diarrhea or constipation (healthy control group only); or * non-english speaking

Keywords: dyspepsia gastrointestinal disease indigestion
impact of suspected preterm labour on cardiometabolic profile and neurodevelopment

Conditions: Preterm Labor

Summary: suspected preterm labour (spl), define as the presence of regular and painful uterine contractions and cervical shortening, constitute a prenatal insult with potential long-term consequences. however, despite recent evidence demonstrating a suboptimal neurodevelopment at 2 years in this population, it remains under-recognized as a significant risk factor for neurodevelopmental disorders or other chronic diseases. the objective of this study is to assess the impact of suspected preterm labour during pregnancy on cardiometabolic profile and neurodevelopment during childhood (6-8 years). prospective cohort study including children whose mothers suffered a suspected preterm labor during pregnancy and paired controls. a neurodevelopment, cardiovascular and metabolic assessment at 6-8 years of age will be performed. a trained psychologist will carry out the neurodevelopment assessment. body composition and physical fitness assessment will be performed by one trained pediatrician and nurse. finally, cardiovascular assessment, including echocardiography and blood pressure, will be performed by two pediatric cardiologists. data regarding perinatal and postnatal characteristics, diet, lifestyle and weekly screen time of the child will be obtained from clinical histories and direct interviews with the families. primary outcome measures will include body mass index and adiposity, percentage of fat mass and total and regional lean mass, bone mineral content and density, cardio-respiratory resistance, isometric muscle strength, dynamic lower body strength, systolic and diastolic blood pressure, left ventricle (lv) systolic and diastolic function, general intelligence index, visuospatial working memory span, visual development test, visual acuity, index of emotional and behavioral problems.


Eligibility criteria:
inclusion criteria: * singleton pregnancy * good understanding and sign of informed consent. exclusion criteria: * multiple pregnancy * malformations * chromosomal diseases * prenatal infections

Keywords: pregnancy preterm labor neurodevelopment cardiovascular metabolic prematurity
quality of dying in the intensive care unit: validation of the caesar scale

Conditions: Anxiety; Depression; Posttraumatic Stress Disorder

Summary: the purpose of the study is to evaluate the quality of the dying process in french icus (assessed by the caesar scale) and to compare physicians', nurses' and relatives perceptions and experiences, with a one-year follow-up of bereaved relatives. our hypothesis is that perception of the quality of dying may impact on relatives' experience of bereavement (anxiety, depression, complicated grief, posttraumatic stress disorder (ptsd)).

seventy percent of all deaths occur in the hospital environment, and amongst them 20% occur in intensive care units (icu). in france, no studies have evaluated the quality of the end-of-life process from both the professional and the lay perspective. the caesar scale has been developed from literature reviews and qualitative interviews with relatives, physicians and nurse to assess quality of dying in icu. our hypothesis is that perception of the quality of dying may impact on relatives' experience of bereavement (anxiety, depression, complicated grief, ptsd).

Eligibility criteria:
inclusion criteria: * adult patients deceased in the icu after at least 48 hours of icu stay * at least one visit of a relative in the icu exclusion criteria: * no french-speaking relative

Keywords: ptsd
a phase 2 study evaluating the efficacy and safety of pf 04494700 in mild to moderate alzheimer's disease

Conditions: Alzheimer's Disease

Summary: the purpose of this study is to evaluate the efficacy and safety of pf 04494700 in participants with mild to moderate alzheimer's disease.


Eligibility criteria:
inclusion criteria: * mini mental state exam (mmse) score between 14-26 (inclusive) at screening. * participants must be receiving acetylcholinesterase inhibitors on a stable dose for at least 4 months prior to randomization exclusion criteria: * current evidence or history of neurological, psychiatric and any other illness that could contribute to non-alzheimer's dementia. * known history of familial ad or any evidence for early onset ad known or possibly associated with genetic mutations. * evidence or history of diabetes mellitus type 1 or type 2. * history or symptoms of autoimmune disorders.

Keywords: ri ri study rage inhibitors
investigating epstein-barr virus associated conjunctivitis

Conditions: Conjunctivitis; EBV Infection

Summary: conjunctivitis means inflammation of the conjunctiva, the thin transparent layer over the white of the eye and under the eyelids. acute conjunctivitis caused by infection is the most common condition seen in ophthalmic emergency departments, accounting for up to 10% of cases. it is responsible for 41% of eye-related general practice consultations. a diagnosis is usually made on the patient's symptoms and signs, despite this being less reliable than laboratory testing. when a cause is found, it is usually a common cold virus called adenovirus, that gets better with time and does not require treatment. through investigating cases of conjunctivitis at moorfields, it has been discovered that in addition to adenovirus, epstein barr virus (ebv) is sometimes detected in conjunctival swabs from individuals with conjunctivitis. ebv is a very common viral infection that 95% of adults have experienced. ebv infection mostly passes unnoticed but when symptoms do occur, they include a sore throat, high temperature, swollen glands and tiredness, often called glandular fever or infectious mononucleosis. conjunctivitis can also occur. ebv remains in the body after infection and rarely causes further problems. the virus can become active again occasionally, which is known as reactivation. reactivation usually passes unnoticed but sometimes is associated with recurrence of symptoms. it is possible that reactivation may cause conjunctivitis. it is not certain, which is will be observed as a part of this study, as it might be the cause of some of the conjunctivitis seen. through a collaboration with university college london (ucl), the aim is to gain further insight into infectious conjunctivitis, particularly in relation to ebv. this will be done by taking a swab of the conjunctiva, a single blood test and a tiny (1-2mm) tissue sample from the inner eyelid. improved knowledge will allow the research team to develop better guidance and treatment for patients with conjunctivitis.


Eligibility criteria:
inclusion criteria: * participants shall be considered eligible for inclusion if: * aged ≥16 years; * working diagnosis of infective (viral) follicular conjunctivitis (\&lt;4 weeks duration) * ebv positive conjunctival swab exclusion criteria: * • present with symptoms/signs such that another diagnosis is deemed more likely, for example topical medication-induced conjunctivitis. * participant declines diagnostic tests or appropriate corneal or conjunctival sample(s) not obtained for any reason
private-sector access to testing for health sustainability

Conditions: HIV Prevention

Summary: new and innovative strategies are urgently needed to increase the uptake of hiv prevention and sexual and reproductive health services among adolescent girls and young women (agyw) in sub-saharan africa. to ensure the real-world sustainability of free distribution of hiv self-test kits to agyw by private drug shops and pharmacies, investigators will rigorously test supply-side subsidy structures for shopkeepers' provision of hiv-self test kits to agyw combined with prosocial motivational supports. the combination of non-monetary and monetary support structures aims to emulate real-world health financing models for public-private partnerships and ultimately aims to improve equity in access to critical prevention services for agyw at scale.

this is an implementation-effectiveness trial that tests program adoption, implementation, and maintenance of free hiv self-test kit (hivst) distribution to adolescent girls and young women (agyw) financed by profits from hivst kit sales to non-agyw customers. to initiate adoption, the study will offer pharmacy and drug shopkeepers the opportunity to procure subsidized hivst to simultaneously distribute to agyw for free (reimbursed by the study mimicking government-supported provision) and sell to non-agyw customers for profit, gradually phasing out procurement subsidies over 36 months to test maintenance of the segmented pricing model for real-world sustainability (aim 1). investigators will implement non-monetary motivation boosters to sustain shopkeeper engagement over the study period and use mixed-methods to understand shopkeepers' experiences and necessary conditions for program maintenance and provider behavior change (aim 2), which will inform the co-design of a progressive scale-up plan to achieve national coverage with tanzanian agyw, public, and private partnership stakeholders (aim 3). at the study's conclusion, investigators will have a comprehensive understanding of the support structures shops need to sustain hivst kit provision for agyw. importantly, the study will contribute to generalizable learning about the structures required for commercially sustainable public-private partnerships for high-impact public health interventions.

Eligibility criteria:
inclusion criteria: * owners/staff of retail drug shops and pharmacies located in the study regions * age 18 and older exclusion criteria: * refusal to install and track sales and distribution of hivst kits using the maisha meds data system provided.

Keywords: hiv tanzania pharmacies agyw hiv self-test kits adolescent girls and young women
respiratory measurement using infrared camera and respiratory volume monitor (exspiron 1xi) for sedation in patients undergoing turp/turb under spinal anesthesia

Conditions: Prostate Cancer; Bladder Cancer

Summary: in patients undergoing spinal anesthesia, the investigators used an infra-red camera and a respiratory volume monitor to determine the accuracy of the ventilation rate of the infra red camera by measuring the respiratory rate, ventilation volume, and ventilation volume with respiratory volume monitor.


Eligibility criteria:
inclusion criteria: * an adult male who underwent endoscopic prostatectomy resection with regular surgery * an adult male who underwent endoscopic bladder resection with regular surgery exclusion criteria: * presenting alteration in respiratory function detected by functional analysis of lung volume and capacity- pneumonectomy patient, severe ipsilateral destroyed lung patient * inability to understand or perform the procedure * asa(american society of anesthesiologists) class 4,5
pyrotinib plus vinorelbine in her2+ metastatic breast cancer patients

Conditions: Breast Cancer

Summary: to evaluate the patterns and treatment outcomes of pyrotinib plus vinorelbine in the real world.


Eligibility criteria:
inclusion criteria: * woman, age \> 18 years old * diagnosed with her2 +metastatic breast cancer * pyrotinib plus vinorelbine for at least one cycle, starting from 2018.05-2020.05 * available medical history exclusion criteria: * medical history was incomplete

Keywords: pyrotinib
newborn screening for critical congenital heart disease

Conditions: Congenital Cardiovascular Malformation

Summary: previous studies have examined the usefulness of pulse oximetry or oxygen saturation to screen for left-sided cardiac lesions. these studies have shown that the occurrence of critical congenital cardiac malformations among asymptomatic newborns is high; the technique of pulse oximetry is reliable for detection of ductal dependant left-sided lesions, simple to operate(requires little time and can be done in the newborn nursery) and is cost effective; there is effective follow-up test (heart ultrasound) and available interventions have an effect on outcome for diagnosed newborns. the importance of this research project is to examine the overall helpfulness of measuring oximetry in newborn infants using somatic oximetry, as well ast to prepare for a population based study in the state of florida.

this study will evaluate up to 50 unaffected newborns and up to 10 known congenital heart disease (chd) newborns using a new oximetry system. this system is interfaced to a laptop computer which computes the difference between central and lower extremity peripheral values, upper and lower body peripheral values, and records all data. this information may differentiate unaffected newborns and chd newborns, and determine the effectiveness of pulse oximetry as a newborn screening for congenital cardiovascular malformations.

Eligibility criteria:
inclusion criteria: * male or female subjects aged 12 hours -2 weeks. * newborns with identified congenital heart disease or newborns without identified congenital heart disease. * congenital heart diagnosis: total anomolous pulmonary venous return (tapvr); atrio-ventricular septal defect ( avsd); coarctation of the aorta; critical aortic stenosis; other cyanotic legions including hypoplastic left heart syndrome ( hlhs) exclusion criteria: * have any concurrent condition which, in the opinion of the investigator, would make the subject unsuitable for the study.

Keywords: congenital cardiovascular malformation newborn
randomized trial of preoperative diets before bariatric surgery

Conditions: Morbid Obesity; Bariatric Surgery; Gastric Bypass

Summary: randomized clinical trial of two preoperative diets before bariatric surgery (gastric bypass)comparing standard diet and prodimed (vlcd) in 100 morbidly obese patients selected for a gastric bypass procedure

morbid obesity, defined as a body mass index (bmi) of \> 40 kg/m² or \> 35 kg/m² with obesity-related comorbidities, is a rapidly growing problem in the western society. in the united states, about 6 million people currently have a bmi of \> 40 kg/m² and another 10 million people have a bmi of \> 35 kg/m² with comorbidities. worldwide, the incidence of morbid obesity has doubled and about 300 million people are now obese. in the netherlands the prevalence is less disturbing but the incidence of morbid obesity is rising progressively to 1.5% of the total population. at this moment surgical therapy is the only treatment option for these patients that results in sufficient long-term weight loss. non-surgical approaches, like low energy diets and behavior modification, are not successful in the long-term with respect to maintaining weight loss and decreasing obesity-related comorbidities. in order to increase weight loss and minimize complications a preoperative diet before bariatric has been advocated. however, the usual vlcd's are poorly tolerated by patients. in this study we aim to compare two preoperative diets in order to find the most suitable for this patient population.

Eligibility criteria:
inclusion criteria: * morbid obesity according to ifso criteria exclusion criteria: * previous bariatric or gastric surgery * severe psychiatric disorders

Keywords: gastric bypass preoperative diet prodimed
dietetic effects of mare's milk in patients with atopic dermatitis

Conditions: Atopic Dermatitis

Summary: the study was performed to investigate the effects of mare's milk on scorad, faecal microbiota and immunological parameters in patients with atopic dermatitis.

mare's milk has been used in the treatment of inflammatory illnesses for centuries since it was known to contain antimicrobial, anti-inflammatory and immunomodulatory substances. the aim of this study was to examine whether the consumption of mare's milk by patients with atopic dermatitis (ad) has a beneficial effect. as a precondition for participating in this study, the subjects were provided information in writing and verbally about the details of the study. informed consent was obtained from all volunteers. before the beginning of the study, all participants were subject to a medical examination in the clinic for dermatology and dermatologic allergology of the friedrich schiller university jena. the ad was diagnosed according to the atopy-score of diepgen. severity of eczema was evaluated by using the scorad score. a skin prick test was performed for the exclusion of type 1 sensitivity to mare's milk. the study was designed as a double blind, placebo-controlled crossover trial. twenty-three patients received 250-ml mare's milk or placebo orally for 16 consecutive weeks. between the two intervention periods, a four week wash-out period without drinking any test substances was introduced. the intensity of ad was examined using the severity scoring of atopic dermatitis (scorad), which was determined at the start of the study and after 4, 8, 12 and 16 weeks of each intervention period. blood samples were taken at the start of the study and subsequently after 8 and 16 weeks. fresh stool samples were taken at the beginning of the study and at the end of each intervention period.

Eligibility criteria:
inclusion criteria: * a clear and definite diagnosis of ad * willingness to use only the recommended drugs * competence regarding the daily documentation of skin state and well being. exclusion criteria: * therapy with non recommended drugs one month before start of the study * active skin infection * apparent asthma * intolerance against milk * long-term therapy with drugs * symptomatic heart disease and/or internal disease * autoimmune diseases, immune defects, and malignoma * alcohol and drug abuse.

Keywords: mare's milk atopic dermatitis endogenous eczema scorad bifidobacteria