Kornimate/medical-research-clean huggingface dataset:
hantavirus nephropathy in north-eastern france : severity risk factors and prognostic tools

Conditions: Hantavirus Nephropathy; Hantavirus Infection

Summary: hantaviruses are emerging pathogens responsible for hemorrhagic fever with renal syndrome. severity risks factors aren't consensual in litterature, mostly related to scandinavian cohorts. a prognostic score was created to help patient's orientation in healthcare system but wasn't independantly validated (hentzien, emerging infectious diseases 2018). this retrospective cohort of hantavirus infected hospitalized adults patients in the north-eastern quarter of france between 2013 and 2022 will specify the kidney damage during infection and risk factors for a severe form (defined par acute kidney injury kdigo 3). the previous prognostic score performance will be evaluated in this cohort.


Eligibility criteria:
inclusion criteria: * hantavirus proven by serology infection * age above 18 years * hospitalisation exclusion criteria: * age under 18 years * fulfill opposition form

Keywords: acute kidney injury hantavirus infection hantavirus nephropathy
epidemiology study of malaria transmission intensity in sub-saharan africa

Conditions: Malaria; Malaria Vaccines

Summary: this epidemiology study is planned to run in parallel with the epi-mal-002 and epi-mal-003 studies, enrolling from the same health and demographic surveillance system (hdss) (or equivalent system) populations. the co-primary objectives are to produce longitudinal estimates of parasite prevalence in humans, and record malaria control measures usage in areas where epi-mal-002 and epi-mal-003 studies will take place.

this study will involve up to 10 annual cross sectional surveys during malaria peak transmission with possible further extension, dependent on the duration of the epi-mal-002 and epi-mal-003 studies. surveys will provide point estimates of parasite prevalence and subsequently a longitudinal assessment of the level of endemicity in each area covered by epi-mal-002 and epi-mal-003. this study will be conducted in parallel to epi-mal-002 and epi-mal-003 in order to assess parasite prevalence and malaria control measures before (epi-mal-002) and after (epi-mal-003) vaccine introduction. by taking into account variations in malaria transmission intensity (mti) and malaria control intervention coverage, it will enable a more complete assessment of the benefits and risks of the vaccine introduction, and thereby more insight into the potential vaccine impact in epi-mal-002/-003, by adjusting incidence data for overall changes in transmission and other malaria control intervention coverage, and assist generalisation of results to other populations.

Eligibility criteria:
inclusion criteria: * subjects' whose parent(s)/legally acceptable representative(s) \[lar(s)\], in the opinion of the investigator, can and will comply with the requirements of the protocol. * a male or female 6 months to \<10 years of age at the time of survey. * signed informed consent or thumb-printed and witnessed informed consent obtained from the parent(s)/lar(s) of the child. exclusion criteria: * child in care. * current active participation in any trial involving administration of an investigational malaria vaccine or malaria drug.

Keywords: malaria mti surveillance study africa rts,s/as01 epidemiology plasmodium falciparum malaria control interventions
daytime profile of salivary progesterone

Conditions: Infertility, Female

Summary: the aim of this study is to perform a 12-hour profile of free saliva progesterone during the luteal phase after fresh and frozen embryo transfer. if progesterone levels in saliva samples show a constant level during daytime, this non-invasive measurement can be used in future art patients with insufficient progesterone levels who might benefit from additional exogenous progesterone supplementation.


Eligibility criteria:
inclusion criteria: * 18-45 years * one or two good quality embryos for transfer on day 5. * bmi \>18,5 \<30 kg/m² exclusion criteria: * no good quality embryos for transfer * uterine abnormalities * one ovary * oocyte donation

Keywords: progesterone saliva ivf frozen embryo transfer
levobupivacaine prolonged wound infusion for postoperative pain relief after breast surgery

Conditions: Acute Pain; Chronic Pain; Wound Infusion; Mastectomy

Summary: the aim of the study is to evaluate efficacy and safety of long term (14 days) wound infusion with levobupivacaine in patients with breast cancer undergoing mastectomy with immediate breast reconstruction: this is a double blind, randomized, parallel group study. the study moves from the concept that nociceptive stimulus last further than 48 hours after surgical intervention: long term analgesia is necessary to provide a real benefit to the patient and provide central sensitization. intralesional catheter is placed at the end of surgery. in the first 24 postoperative hours we provide continuous wound infusion with levobupivacaine 0,25% 5ml/h with morphine patient controlled analgesia (pca) when nrs \>4. from the second postoperative day morphine pca is removed and patients are randomized to receive levobupivacaine 0,25% or saline, released with 5 ml boluses and lock-out of 2 hours, with rescue analgesia with tramadol 37,5 mg + acetaminophen 325 mg oral fix combination (patrol). intralesional catheter is taken off 14 days after surgical intervention or after 36 hours of non-use. pain evaluation (nrs at rest and movement) and oral rescue doses consumption are performed; pain physicians also care about any catheter-related or drug-related side effect, registering number of total boluses. patients are provided with a home diary for pain scores to be filled and brought back when surgical visit is performed. a phone interview at 1 and 3 month is performed to investigate pain chronicization. surgical evaluation is provided, also to establish any catheter-related infective or healing complication. physiatric evaluation before the intervention and 1 and 3 months is provided to ensure rehabilitation process. a validated questionnaire (short form 36/ sf-36) must be filled by all patients, to understand differences in return to a normal quality of life and to social activities between the two groups.


Eligibility criteria:
inclusion criteria: * f; age 18 to 70 * american society of anesthesiologists (asa) i e ii; * breast cancer ( din 2 e 3, o lin 2 e 3 sec. tavassoli) scheduled for nipple-sparing mastectomy, simple mastectomy, skin-sparing mastectomy, skin-reducing mastectomy c, lymphnode biopsy and axillary dissection; * immediate sub-pectoral prosthetic reconstruction; * signed informed consent. exclusion criteria: * preexisting pectoral, axillar, thoracic homolateral pain * habitual opioid consumption; * drug-alcoholics addiction ; * icu postoperative recovery; * kidney failure (creatinin \> 2 g/dl, creatinin \<clearance 30 ml/h) and/or hepatic failure (cholinesterase \< 2000 ui); * cardiac arrhythmias o; * epilepsy; * psychiatric, cognitive disorders, mental retardation; * coagulopathies (inr \> 2, activated partial thromboplastin time - aptt\>44 sec); * platelet count less than 100.000/mm3; * bmi \> 30; * allergies to study drugs.
evaluation protocols for isolation of analytes from urine for future oncology applications

Conditions: Breast Cancer; Prostate Cancer; Urine; Liquid Biopsy

Summary: the aim of this study is to evaluate and optimize protocols for the isolation and analysis of analytes in urine (cell-free nucleic acids, extracellular vesicles and proteins). the following factors will be evaluated (1) volumetric collection with colli-pee®, a collection device developed by novosanis for standardized collection of urine, and (2) stabilization methods. this is a prospective study in which urine samples will be collected from healthy volunteers, urine samples and a blood sample from pregnant women and cancer patients with solid tumors with emphasis on breast- and prostate cancer. the participants will be asked to provide a urine sample collected with the colli-pee® device and fill out an online questionnaire to collect usability data. thereafter, the urine sample will be aliquoted to be used in different pilot studies for the protocol optimization. for the pilot study where the effect of volume will be assessed, participants will be requested to collect multiple samples with different colli-pee® variants and fill out questionnaires accordingly.


Eligibility criteria:
inclusion criteria: * being at least 18 years old * being able to understand and read dutch * for cancer patients specifically: patients suffering from local and systemic cancers (e.g. breast, prostate cancer) exclusion criteria: * for cancer patients specifically: patients suffering from a blood cancer

Keywords: urine liquid biopsy oncology colli-pee
evaluating a family-based nutrition and garden intervention in rural guatemala

Conditions: Malnutrition; Dietary Modification

Summary: this is a pilot quasi-experimental study to evaluate the impact of adding a family garden intervention to an existing wrap-around nutrition intervention for children with chronic malnutrition and their family. the existing nutrition intervention is provided by community health workers affiliated with wuqu' kawoq \| maya health alliance. a single community in rural guatemala will participate in the intervention, with the goal to recruit approximately 70 families in the combined nutrition/garden intervention. a nearby community, also participating in the nutrition intervention, will serve as a nonrandom contemporaneous control. aims of the study include: 1. evaluate the impact of the garden intervention on maternal and child dietary diversity, child growth and household food insecurity. 2. use the reach effectiveness adoption implementation maintenance (re-aim) framework to conduct a preliminary implementation analysis, to guide a future, well-controlled study.


Eligibility criteria:
inclusion criteria: * children who are already scheduled to be enrolled in maya health alliance's intensive home-based nutrition program (non-investigational, standard of care) who are 6-24 months of age at the time of enrollment with a height-for-age z scores of \<= -2.5 * at least one caregiver willing to provide written informed consent * caregiver of a child enrolled in the study (for caregiver/head of household outcomes), including women who may be pregnant * planned residence in the study area for the next 18 months exclusion criteria: * children with acute malnutrition (weight for length z scores of \<= -2.0) * children with a severe medical illness that affects growth (e.g., heart disease, kidney disease, genetic condition) as determined by a maya health alliance staff physician. * caregivers with cognitive impairments that prevent them from being able to provide informed consent

Keywords: guatemala indigenous dietary diversity chronic malnutrition maya agriculture behavior change food insecurity
pk/pd, long-term safety and efficacy of tamsulosin treatment in children with neurogenic bladder

Conditions: Bladder, Neurogenic

Summary: aims of this study is to characterize the pharmacokinetic/pharmacodynamic profile and evaluate the safety, efficacy and tolerability, of tamsulosin hydrochloride as treatment in children with a neuropathic bladder, over the course of 12 months of active treatment.


Eligibility criteria:
inclusion criteria: * neuropathic bladder secondary to known neurological disorder * elevated detrusor leak point pressures (lpp) ≥40 cm h2o confirmed by two measurements at baseline exclusion criteria: * clinically significant abnormalities as determined by the investigator * a history of relevant orthostatic hypotension, fainting spells or blackouts

Keywords: tamsulosin pediatric neurogenic bladder
pharmacokinetic study to compare the blood levels of abatacept manufactured at lonza biologics to the blood levels of abatacept manufactured at the devens, massachusetts (ma) facility of bristol-myers squibb

Conditions: Rheumatoid Arthritis

Summary: the purpose of this study is to determine whether the blood levels of abatacept (bms-188667) drug product manufactured at lonza biologics and the devens, ma facility of bristol-myers squibb are comparable in healthy subjects

primary purpose of this study is to compare the pharmacokinetic (pk) of abatacept (bms-188667) manufactured at lonza relative to abatacept (bms-188667) manufactured at devens, ma facility following a single intravenous infusion of 750 mg in healthy subjects

Eligibility criteria:
inclusion criteria: * healthy subjects as determined by no clinically significant deviation from normal in medical history, physical examination, electrocardiograms (ecgs), and clinical laboratory determinations * body weight will be between 60 and 100 kg, inclusive exclusion criteria: * any significant acute or chronic medical illness * any major surgery within 4 weeks of study drug administration * smoking more than 10 cigarettes per day * recent (within 6 months of study drug administration) drug or alcohol abuse. * positive blood screen for hepatitis c antibody, hepatitis b surface antigen, or human immunodeficiency virus-1, human immunodeficiency virus-2 antibody * history of any significant drug allergy or asthma * women who are pregnant or breastfeeding and/or unwilling or unable to use an acceptable method to avoid pregnancy for the entire study period
definitive (chemo)radiotherapy for patients with esophageal cancer - 3jecrog r-01

Conditions: Esophagus Cancer; Chemoradiation; Chemotherapy Effect; Radiotherapy Side Effect

Summary: the aim of this observational study is to retrospectively collect survival data for 3000 primary esophageal cancer patients from multicenter between january 2000 to present. based on a cox model, we want to develope a nomogram that predicts local recurrence, distant metastases, and survival for patients treated with radiotherapy or chemoradiotherapy with or without chemotherapy.


Eligibility criteria:
inclusion criteria: * histologically confirmed squamous cell carcinoma, adenocarcinoma of the esophageal or esophagogastric junction unresectable or potentially resectable tumor (ct3-4n0-1m0-m1b, without visceral metastasis, according to ajcc 6th) based on standard primary staging by eus and ct * age\>18 years * no distant metastasis other than supraclavicular lymph nodes * no prior history of thoracic radiation * patients must have normal organ and marrow function as defined below: leukocytes: greater than or equal to 3,500 g/l; platelets: greater than or equal to 100,000/mm3 .hemoglobin:greater than or equal to 10g/l .total bilirubin: within normal institutional limits; ast/alt: less than or equal to 1.5 times the upper limit; creatinine within normal upper limits exclusion criteria: * patients with other cancer history except cervical carcinoma in situ and non-malignant melanoma skin cancer during 5 years before diagnosis of esophageal cancer * pregnant or lactating females * contraindication for radiotherapy or chemotherapy
walking and thinking - brain activity during complex walking in people with multiple sclerosis

Conditions: Multiple Sclerosis; Gait Disorders, Neurologic; Neuro-Degenerative Disease; Aging

Summary: every-day life means being part of a complex environment and performing complex tasks that usually involve a combination of motor and cognitive skills. however, the process of aging or the sequelae of neurological diseases such as multiple sclerosis (ms) compromises motor-cognitive interaction necessary for an independent lifestyle. while motor-cognitive performance has been identified as an important goal for sustained health across different clinical populations, little is known about underlying brain function leading to these difficulties and how to best target these motor-cognitive difficulties in the context of rehabilitation and exercise interventions. the challenge of improving treatments of motor-cognitive difficulties (such as dual-tasking and navigation) is daunting, and an important step is arriving at a method that accurately portrays these impairments in an ecological valid state. the investigators aim therefore to explore brain function during complex walking in ms (in comparison with people with parkinson's disease and healthy controls) by investigating the effects of neurological disease on motor-cognitive performance and its neural correlates during three conditions of complex walking (dual-task walking, navigation and a combination of both) using non-invasive measures of brain activity (functional near infrared spectrometry, fnirs) and advanced gait analysis in real time in people with ms (in comparison with people with parkinson's disease and healthy adults).


Eligibility criteria:
inclusion criteria: * 18 years or older * with an ms diagnosis according to mcdonald criteria * with the ability to walk without a mobility device for ≥5 minutes continuously. exclusion criteria: * disease or condition that affects cognition, gait or balance. * ms relapse or change of disease-modifying treatment within the past eight weeks.

Keywords: functional near infrared spectrometry gait physical activity cognition brain activity
a study to evaluate the safety, pharmacokinetics, and activity of ro7502175 as a single agent and in combination with checkpoint inhibitor in participants with locally advanced or metastatic solid tumors

Conditions: Locally Advanced or Metastatic Solid Tumors; NSCLC; HNSCC; Melanoma; TNBC; Esophageal Cancer; Gastric Cancer; Cervical Cancer; Colorectal Cancer; Urothelial Carcinoma; Clear Cell RCC; HCC

Summary: this is a first-in-human study to evaluate the safety, tolerability, pharmacokinetics (pk), and anti-tumor activity of ro7502175 when administered as a single agent and in combination with atezolizumab or pembrolizumab in adult participants with locally advanced or metastatic solid tumors, including non-small-cell lung cancer (nsclc), head and neck squamous cell carcinoma (hnscc), melanoma, triple-negative breast cancer (tnbc), esophageal cancer, gastric cancer, cervical cancer, colorectal cancer (crc), urothelial carcinoma (uc), clear cell renal cell carcinoma (rcc) and hepatocellular carcinoma (hcc). participants will be enrolled in 2 stages: dose escalation and dose expansion.


Eligibility criteria:
inclusion criteria: * life expectancy at least 12 weeks * eastern cooperative oncology group (ecog) performance status of 0 or 1 * measurable disease according to response evaluation criteria in solid tumors (recist) version 1.1 * histologically confirmed locally advanced, recurrent, or metastatic incurable solid tumor malignancy * tumor specimen availability exclusion criteria: * pregnant or breastfeeding or intention of becoming pregnant during the study or within 4 months after the final dose of ro7501275, or 4 months after the final dose of pembrolizumab, or 5 months after the final dose of atezolizumab * any anti-cancer therapy, whether investigational or approved, including chemotherapy, hormonal therapy, or radiotherapy, within 3 weeks prior to initiation of study treatment * active hepatitis b or c or tuberculosis * positive test for human immunodeficiency virus (hiv) infection * acute or chronic active epstein-barr virus (ebv) infection at screening * administration of a live, attenuated vaccine (e.g., flumist) within 4 weeks before first ro7502175 infusion * symptomatic, untreated, or actively progressing central nervous system (cns) metastases * active or history of autoimmune disease * prior allogeneic stem cell or organ transplantation
oral glucose tolerance test and post partum diagnosis of diabetes mellitus, type 2 (dt2 post-partum)

Conditions: Gestational Diabetes

Summary: diabetes mellitus, type 2, is a chronic disease which can be linked with many complications in connexion with impaired blood glucose balance. it diagnosis in risky subjects such as in patients with medical history of gestational diabetes is therefore imperative to prevent its complications. actual guidelines recommend an oral tolerance glucose test, measuring glucose levels after oral glucose intake (75g), between 6 an 12 weeks after childbirth. but studies reveal a low diagnosis rate. the study of the current practices of diagnosis methods seem to be essential in order to improve this diagnosis.


Eligibility criteria:
inclusion criteria: * patients followed in endocrinology at the hospital of vienne for gestational diabetes, whom benefited an educational therapy session between the 01/01/2016 and the 31/12/2016 inclusive. exclusion criteria: * minor patients or under legal protection (guardianship) * patients who not speak french * patients who did not declared an attending physician * refusal to take part in the survey * patients lost to follow-up before childbirth * patients whose pregnancy ended by foetal death. * pre-existing diabet before pregnancy
evaluation of the cardioprotective effect of l-carnitine and silymarin in patients receiving anthracycline chemotherapy

Conditions: Breast Cancer

Summary: the study aim to protect patients received anthracyclines containing chemotherapy from cardiotoxcity induced by anthracyclines derivatives. by using l-carnitine and silymarin for protection the heart from anthracyclines toxicities, and in addition its a comparitive study between l-carnitine and silymarin.

aim: anthracycline induced cardiotoxicity is the most common constrains of its use in treatment of various types of cancer. this study aimed to investigate benefits from adding l-carnitine and silymarin compared to anthracycline chemotherapy alone in patients with cancer. methods: 83 patients were recruited from clinical oncology department, tanta university, egypt, then prospectively randomized to receive their anthracycline containing therapeutic regimen, control group (n=33) or anthracycline plus l-carnitine, l-carnitine group (n=25), or anthracycline plus silymarin, silymarin group (n= 25). blood samples were collected at begging and after 6 months to measure ldh, ck-mb, ctn i, anticardiolipin igg, fe, ferritin and tibc and % of saturation. % ef was documented. data were statistically analyzed by anova and paired t test. p \<0.05 was statistically significant.

Eligibility criteria:
inclusion criteria: * cancer patients receiving anthracycline chemotherapy in their protocol alone (without any cardioprotective agent), * aged 20-60 and * female patients were included. exclusion criteria: * patients with a history of heart failure, arrhythmia, history of cardiac catheterizations or, history of angina, uncontrolled hypertension and uncontrolled diabetes, * patients with impaired liver function tests, * previous anthracycline-containing regimens and any cardiotoxic chemotherapy regimens, * previous history of chest wall irradiation. * brain metastasis, * pregnant patients and * patients who refused informed consent,

Keywords: anthracycline-containg chemotherapy cardiotoxicity breast cancer patients slymarin l-carnitine
comparison of hyaluronidase and dexametasone in reduction of postoperative edema

Conditions: Edema; Pain; Trismus; Infection, Surgical Site

Summary: the present study is designed to reveal effectiveness of hyaluronidase and dexamethasone on reduction of postoperative edema, pain, trismus, and infection. for this purpose, 60 participants with symmetrical mandibular wisdom teeth enrolled the present study. all measurements and evaluations were performed before and 1, 2, 3, and 7 days later the operation.


Eligibility criteria:
inclusion criteria: * symmetrical mandibular wisdom teeth with bone retention * patients who are signed informed consent and acceptance of study involvement forms exclusion criteria: * existence of any systemic disease * existence of any periodical drug intake * existence of difference in operation times of right and left impacted wisdom teeth extractions more than 5 minutes * existence of pregnancy * existence of breastfeeding

Keywords: postoperative edema wisdom teeth trismus pain control wound infection