Kornimate/medical-research-clean huggingface dataset:
feasibility study for pandas

Conditions: Inguinal Hernia; Developmental Delay Disorders

Summary: we have been asked to participate in the pediatric anesthesia neurodevelopmental assessment study (pandas), which is a study to compare neurocognitive functions in sibling pairs: one of whom had exposure to anesthesia during inguinal hernia surgery before three years of age (exposed) and the other who was not exposed to anesthesia or surgery in the first three years of life (unexposed). a consortium of approximately 6 hospitals is doing this feasibility study to determine if there is an adequate number of subjects for each of the two age groups before the formal study begins.

feasibility study to obtain information through a telephone interview with parents of eligible children once we identify the children who were less than one year of age and those between the ages of 1 and 3 that who had inguinal hernia surgery during the years of 1999-2007, we will call the parents to determine if the index patients have siblings. if so, we would also ask if there is a sibling within 3 years of the index patient's age and if they have had no exposure to anesthetics or sedatives before their third birthday. exclusion criteria for both index patients and siblings would include gestational age at birth of \< 36 weeks, any history of hospitalization, including neonatal icu, a history of cns, cardiac, or pulmonary diseases requiring medical treatment, or a history of subsequent surgery or exposure of anesthetics or sedatives.

Eligibility criteria:
inclusion criteria: 1. males or females age 0 to 1 year. 2. inguinal hernia surgery between 1/1/1999 and 12/31/2007. 3. parental/guardian permission (informed consent). exclusion criteria: 1. gestational age \< 36 weeks. 2. any history of hospitalization, including neonatal icu. 3. a history of cns, cardiac, or pulmonary diseases requiring medical treatment. 4. history of subsequent surgery or exposure to anesthetics or sedatives at less than 3 years of age. -

Keywords: phone interview anesthesia siblings inguinal hernia neurologic examination developmental delay disorders
prophylactic antibiotics in cystectomy with diversion

Conditions: Muscle-Invasive Bladder Carcinoma; Radical Cystectomy; Ileal Conduit; Neobladder Diversion

Summary: using a randomized 2 arm design, this study is being conducted to test for non-inferiority of no prophylactic antibiotic therapy versus the prophylactic oral antibiotic, nitrofurantoin, through comparison of rates of postoperative urinary tract infections within the 90-day postoperative period in patients with muscle invasive bladder cancer who undergo radical cystectomy with urinary diversion.


Eligibility criteria:
inclusion criteria: * presence of muscle invasive bladder cancer and planning to undergo radical cystectomy with either ileal conduit or neobladder diversion. * 18 years of age or older exclusion criteria: * currently receiving antimicrobials for active infection * poor renal function with gfr \< 30 ml/min * allergy to nitrofurantoin and unable to take an alternative antibiotic (cephalexin, trimethoprim-sulfamethoxazole, or ciprofloxacin) * pregnancy * unable to provide informed consent
the lymphocyte/neutrophil ratio as a prognostic index for short term outcome in the icu admitted covid-19 adult patients

Conditions: Covid19

Summary: 1. ry outcome includes the correlation between lymphocyre /neurtophll ratio (lnr) and mortality rate during hospital stay in the icu admitted covid 19 patients. 2. ry outcome(s) include the lnr and its correlation with icu stay, the need for mechanical ventilation, renal impairment.

in december 2019,the covid-19 virus has been mainly breaking out in wuhan in china as pneumonia affecting patients . common clinical features during hospitalization started to appear including acute respiratory infection , inflammatory reaction , fever, pneumonia, cough, fatigue , anosmia . the patient known suspected if he has a clinical picture of viral pneumonia, exposure history, and radiographic findings \[ct\] or \[mri\] chest consistent with covid-19 pneumonia. the gold standard and the final diagnosis (pcr) positivity for the presence of coronavirus . the immune response to respiratory infection causes neutrophils to collect inside the lung especially the alveoli. neutrophils aggregation may lead to collateral tissue damage and cytotoxicity. according to previous studies apoptosis of lymphocytes occurred due to the release of anti-inflammatory cytokines resulting in lymphopenia. high levels of circulating neutrophils have been demonstrated in covid-19 patients( a lot of literatures and studies have demonstrated the value of what is called neutrophil/ lymphocyte ratio (lnr) as a simple prognostic ratio correlated to morbidity and mortality. up to our knowledge, there is no study utilized such ratio in covid-19 icu admitted patients, so that, this study has been built

Eligibility criteria:
inclusion criteria: 1. adult patients (aged ≥18 years) 2. patients who need non-invasive ventilation (niv or cpap) or invasive ventilation (intubation) exclusion criteria: 1. previous diagnosis of severe liver or kidney failure. 2. patients with human immunodeficiency virus (hiv) infection. 3. patients with previous hematological diseases (leukemia) that condition alterations in blood counts. 4. consumption of treatments with any type of immunosuppressants prior to admission that conditions low lymphocytes. 5. patients with bone marrow depression.
a study of nexium (esomeprazole) 40 mg once daily in subjects with symptoms of gastroesophageal reflux disease (gord) after treatment with a full dose of proton pump inhibitor (ppi)

Conditions: Gastroesophageal Reflux Disease

Summary: the purpose of this study is to assess how patients with gastro-oesophageal reflux disease (heartburn) who are currently receiving treatment with a proton pump inhibitor but are still experiencing symptoms will benefit from a change in treatment.


Eligibility criteria:
inclusion criteria: * persisting symptoms of gord despite previous treatment with a full dose proton pump inhibitor * informed consent * over 18 years of age exclusion criteria: * current course of proton pump inhibitor treatment for more than 8 weeks prior to enrolment in the study * more than 1 other course of ppi treatment in the previous 12 month * previous use of esomeprazole * presence of alarm symptoms

Keywords: heartburn reflux proton pump inhibitor
a clinical study of a zoster vaccine in healthy adults >= 40 years

Conditions: Herpes Zoster

Summary: varicella-zoster virus (vzv) is a herpesvirus that causes two distinct clinical syndromes.primary infection is manifested as varicella (chickenpox), whereas reactivation of latent vzv results in a localized eruption known as herpes zoster. most people 40 years of age or older had evidence of previous vzv infection. this study plans to have 522 adults above 40 years old involoved in a randomized, double-blind, placebo-controlled trial of an investigational live attenuated zoster vaccine. the investigational vaccine is produced by shanghai institute of biological products co., ltd. the safety and immunogenicity of the zoster vaccine is evaluated.


Eligibility criteria:
inclusion criteria: * healthy volunteers aged over 40 years (male or female). * able to comply with all clinical trial protocol requirements and willing to complete all the visit plan process during the whole clinical trial observation period. * able to understand the content of informed consent and willing to sign the informed consent. * able to complete the diary card independently. * patients with chronic diseases need to be in a stable period. * axillary temperature ≤37.0°c. exclusion criteria: * prior history of herpes zoster. * prior history of vaccination with herpes zoster vaccine or chickenpox vaccine. * history of allergic disease likely to be exacerbated by any component of the vaccine. * taking immunoglobulins and/or any blood products within the last 3 months or will receive these products during the study period. * taking certain pharmaceuticals to be like salicylate kind, including aspirin, and difluorosalicylic, or going to take these medicine during the study period. * participation in another research study involving receipt of an investigational product in the last 30 days. * prior administration of live vaccine in last 30 days. * prior administration of subunit vaccine, inactivated vaccine or allergic therapy in last 14 days. * history of serious disease and the participation in the clinical trial is likely to increase the disease risk and interfere with the observation of clinical trial index. * taking immunosuppressive therapy in last 6 months. * any autoimmune disease or immunodeficient state, autoimmune disease or immunodeficient disease. * active tuberculosis patient. * acute or chronic infections at the vaccination day (axillary temperature≥ 38.0°c). * coagulation disorders (coagulation factor deficiency, coagulopathy or platelet disorder) diagnosed by doctors, or obvious bruises or blood coagulation noticed. * woman who is breast-feeding. * previous history of mental and neurological diseases (e.g. depression, epilepsy or convulsion) * planned to move before the end of the study or leave the country for a long time during the scheduled study visit. * abnormal blood routine and biochemical indexes before inoculation (except for minor abnormalities that are not clinically significant as judged by doctors) * any other conditions may compromise the safety or availability of participants in the judgment of the investigator.

Keywords: vzv
prostate cancer screening and dietary heterocyclic amines in african american men

Conditions: Prostate Cancer

Summary: rationale: screening may help doctors find prostate cancer sooner, when it may be easier to treat. the amount of heterocyclic amines in the diet may affect prostate cancer screening results and the risk of prostate cancer. purpose: this phase ii trial is studying prostate cancer screening and dietary heterocyclic amines in african american men.

objectives: * estimate dietary heterocyclic amine (ha) exposure in african american men who use ha-forming meats and cooking methods. * correlate dietary ha exposure with prostate-specific antigen and digital rectal exam screening results (i.e., higher ha exposure with increased abnormality in prostate cancer screening results) in these participants. outline: this is a prospective study. participants complete a routine medical questionnaire and undergo a detailed dietary interview that focuses on meat consumption, cooking preferences, and other factors that may be associated with prostate cancer risk. participants then undergo a digital rectal exam (dre) and blood collection for prostate-specific antigen (psa) testing (total psa and % free psa). results of psa testing and dre, including follow-up instructions (if needed), are sent to the participant 3-4 weeks later. blood samples are also examined by phenotypic assays for uv-damage induced nucleotide excision-repair capacity. projected accrual: a total of 800 participants will be accrued for this study.

Eligibility criteria:
disease characteristics: * african american male * no previous diagnosis of prostate cancer * desires prostate cancer screening as a routine preventative medical service patient characteristics: * lives in or near oakland, california * speaks english * no medical or other disability (e.g., blindness, psychological dysfunction, or amputation) that would preclude study participation prior concurrent therapy: * not specified

Keywords: prostate cancer
colorectum+ digital system for postoperative quality improvement in colorectal cancer

Conditions: Colorectal Carcinoma

Summary: this is a single-center, prospective, interventional study. a total of 236 colorectal cancer patients who underwent surgery will be enrolled and followed for 52 weeks. the digital healthcare quality management system, based on the colorectum+ model, will be used for post-treatment quality evaluation and continuous improvement. patients will be managed using an internet+ post-treatment healthcare management platform. the platform integrates ai technology for real-time symptom analysis and alerts. patients will report symptoms and health data through the platform, which will generate alerts based on symptom severity to guide appropriate interventions. follow-up assessments will include patient adherence, satisfaction, quality of life, and healthcare utilization. the study expects to demonstrate that the digital healthcare quality management system improves follow-up rates, enhances patient adherence, reduces unplanned hospital visits, and increases overall patient satisfaction. the findings aim to provide evidence for the implementation of digital management systems in colorectal cancer post-treatment care, potentially leading to improved long-term outcomes for patients.

the aim of this study is to evaluate the adherence of postoperative colorectal cancer patients using a digital follow-up platform. the primary endpoint is follow-up rate at 3 months after surgery. the secondary endpoints are: follow-up rate at 6, 9, and 12 months, adherence during 12 months, medication adherence (mms-4), the number and reasons for alerts triggered by patients, the frequency and reasons for patient-initiated report, quality of life (fact-c), patient satisfaction (facit-ts-ps), the system's usability (sus), the monitoring rates of imaging exams, colonoscopies, and cea markers at 3, 6, 9, and 12 months will be analyzed. differences in clinical outcomes: progression-free survival, overall survival, adverse events, the incidence of complications, hospital admissions (unplanned hospital visit rates, average unplanned hospital stay duration, and potentially preventable emergency visits) are additional outcomes.

Eligibility criteria:
inclusion criteria: * over 18 years old. * pathologically confirmed colorectal cancer patients. * underwent surgery at the colorectal cancer diagnosis and treatment center, gastrointestinal surgery, renji hospital, shanghai jiao tong university school of medicine. * signed informed consent form. exclusion criteria: * unable to access electronic devices that can connect to the internet or mobile communications. * uncontrolled psychiatric illness. * the ecog score is greater than or equal to 3. * deemed unsuitable for participation by the investigator.

Keywords: colorectal carcinoma follow-up ehealth adherence
controlling and lowering blood pressure with the mobius hd™ (calm-fim_eur)

Conditions: Hypertension

Summary: to evaluate the safety and performance of the mobiushd system in subjects with resistant hypertension.

this is an open-label, multicenter, first-in-man clinical trial to be conducted in europe. eligible subjects with stage 2 resistant systemic arterial hypertension currently being treated with a minimum of three (3) anti-hypertensive drugs, who consent to study participation will be assigned to treatment with the mobiushd system. potential study participants will be consented and then screened at two (2) baseline visits beginning at least 30 days prior to mobiushd placement. qualified patients will undergo placement of the mobiushd under angiographic visualization, and will then be followed for 36 months.

Eligibility criteria:
inclusion criteria: * office cuff sbp ≥ 160 mmhg measured per protocol instructions following at least one (1) month of maximally tolerated therapy with at least three (3) anti-hypertensive medications, of which at least one (1) must be a diuretic unless patient has history of intolerance, ineffectiveness or contraindications. exclusion criteria: * known or clinically suspected baroreflex failure or autonomic neuropathy

Keywords: hypertension
effects of sevoflurane and desflurane on treg

Conditions: Transplant; Failure, Kidney

Summary: this prospective interventional study aims to compare sevoflurane and desflurane anesthetic agents on regulatory t cell (treg) numbers and its cytokine production in patients undergoing living donor kidney transplant (ldkt).

all patients with end stage renal disease (esrd) need renal replacement therapy, either dialysis or kidney transplantation. dialysis, despite its effectiveness in prolonging esrd patients' lives, is a burden. successfulness in kidney transplantation will restore good quality of life in esrd patients. however, one of the most important complications that lead to transplant failure is graft rejection. it is already known that the pathophysiology of the rejection is immune response. recent evidence showed that regulatory t cell (treg) plays a central role in preventing graft rejection by inhibiting recipient alloimmune response (1-3). characterization of treg numbers and/or functional changes under various conditions may lead to a new preventive measure and/or a novel therapeutic strategy for graft rejection. kidney transplantation is conducted under general anesthesia. interestingly, several agents used in general anesthesia have also modulated immune functions (4-12). although the effect of inhalation anesthetic agents on leukocyte count has been shown, the effect on treg function has totally been unknown. knowing the effects of inhalation agents on treg numbers and functions will be beneficial to intraoperative management during transplant surgery, aiming toward reducing the risk of graft rejection in the future.

Eligibility criteria:
inclusion criteria: * patients receiving 1st living donor kidney transplantation exclusion criteria: * hyperacute graft rejection * pre-existing autoimmune or immunodeficiency diseases in recipients * receiving blood product during 24-h perioperative period * patient refuse to participate this study at any time point

Keywords: regulatory t cells sevoflurane desflurane cytokines flow cytometry living donor kidney transplant
thromboprophylaxis in critically ill patients

Conditions: Venous Thromboembolism

Summary: intensive care patients are at high risk to develop deep venous thrombosis and pulmonary embolism. despite anticoagulation with heparin 7% of icu patients suffer from this serious complication. optimal regimens for prevention of vte have been established in medical patients only and are not known for icu patients. it was therefore the aim of this study to compare the bioavailability of a low molecular weight heparin in icu patients and in medical patients. furthermore, we looked wether a 50% dose increase resulted in better bioavailability of this drug.

background: the optimal dose regimen of low molecular weight heparins (lmwh) for thromboprophylaxis in critically ill patients is unknown. objectives: we performed a prospective, randomized study to determine anti-xa activities following subcutaneous administration of 5000 iu or 7500 iu dalteparin for thromboprophylaxis in icu patients compared with medical patients receiving the standard dose of 5000 iu. patients and methods: twenty-five icu patients received 7500 iu (group 1) and 29 icu patients received 5000 iu dalteparin subcutaneously (group 2) for thromboprophylaxis. twenty-nine medical patients receiving 5000 iu dalteparin served as control group (group 3).

Eligibility criteria:
inclusion criteria: * requirement for prophylactic anticoagulation, patient age ³19 years, creatinine clearance within normal range, prothrombin time \>30% and thrombocyte counts \>100 g/l. exclusion criteria: * estimated time of admission less than 24 hours, full anticoagulation, renal failure, history of heparin-induced thrombocytopenia, hereditary or acquired coagulation disorders.

Keywords: dalteparin, critically ill, thromboprophylaxis
flovent hydrofluoroalkane (hfa) in 6-12 month old subjects

Conditions: Asthma

Summary: the purpose of this study is to address an food drug and administration (fda) request to provide safety data in pre-asthmatic patients, ages 6 months to \<12 months, following administration of fluticasone propionate hfa.

a repeat-dose, open-label, 2-session study to assess the systemic exposure to, and pharmacodynamics of, fluticasone propionate hfa inhalation aerosol 88mcg administered twice-daily for 28 days delivered via an mdi and valved holding chamber with infant facemask to subjects ages 6 months to \<12 months who have experienced 2 or more wheezing episodes in the preceding 6 months

Eligibility criteria:
inclusion criteria: * subjects who have experienced 2 or more wheezing episodes in the previous 6 months. * subjects may not have taken any corticosteroids in the 4 weeks prior to dosing * parents/guardians should be able to read and comprehend diary information collected throughout the study * parents must be able to demonstrate the ability to use the facemask and spacer used to administer study drug exclusion criteria: * subjects who weigh less than 7 kg * subjects who are taking any drugs that inhibit or induce the cytochrome p450 isoform * any parents who have a history of psychiatric disease, intellectual deficiency, substance abuse that would compromise the validity of the consent

Keywords: asthma infants flovent spacer
longitudinal study in clinically isolated syndrome (cis) patients treated with interferon beta

Conditions: Clinically Isolated Syndrome

Summary: the aim of this study is to evaluate the role of cognitive disorders and quality of life in patients with cis, considered as high risk to develop an ms, treated with interferon beta. this prospective observational study will include 120 patients, all treated and evaluated annually with neurological extensive examination, ophthalmologic screening (oct, of, vep, vf), auto questionnaire about fatigue (musicol, elif), quality of life (sep-59), and conventional mri.


Eligibility criteria:
inclusion criteria: * patients older than 18 years, * patients with cis and temporo spatial dissemination for less than one year * patient without prior immunomodulatory treatment * patient informed of cis diagnosis and ms according to mcdonald criteria, * patients with edss inferior or egal to 5,5 * patients usually french-reader and with mms \>24 * patients informed of study protocol * patients agree to sign informed consent * patients with affiliation number from social french département. exclusion criteria: * secondary progressive ms * patient with acute relapse * patient already treated with ifn * corticosteroids less than 15 days * patient with severe dépressive disorders * patient already included in clinical study * patient \< 18 years * patient with known contra indications for beta interféron * every reason with can provoke an interruption of the study, regarding a patient empechment * contre indications for mri or other tests required in the study * pregnancy or lactation * patient under juridic protection

Keywords: ms cis ifn mri oct qol