Kornimate/medical-research-clean huggingface dataset:
chp-bv followed by consolidation with high-dose therapy / asct as frontline treatment of patients with eatl type 1.

Conditions: Enteropathy Associated T-cell Lymphoma

Summary: it has been recently reported that eatl type 1, but not refractory coeliac disease, strongly expressed cd30 and might benefit from brentuximab vedotin. since the safety profile of the combination brentuximab vedotin and chp is known and since the role of etoposide as part of induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity of the combination brentuximab vedotin and chp followed by hdt/asct, as frontline treatment of eatl.

brentuximab vedotin is an anti-cd30 monoclonal antibody conjugated to the cytotoxic drug monomethyl auristatin e. it is currently evaluated in combination with multi-agent chemotherapy as frontline treatment of systemic alcl (salcl) and other cd30-positive mature t cell and nk cell lymphomas. preliminary results of this phase 1 study have been presented at the 2012 ash annual meeting: 26 patients have been treated with combination brentuximab vedotin and chp. nineteen of 26 patients had a diagnosis of salcl and 7 patients had a diagnosis of another mature tor nk-cell lymphoma (eatl, n=1). the maximum tolerated dose of brentuximab vedotin in combination with chp was not exceeded at 1.8 mg/kg iv. adverse events were manageable. all patients achieved an objective response, with 23 patients (88%) achieving a complete response (cr). all 7 non-salcl patients achieved a cr. finally, it has been recently reported that eatl type 1, but not refractory coeliac disease, strongly expressed cd30 and might benefit from brentuximab vedotin. since the safety profile of the combination brentuximab vedotin and chp is known and since the role of etoposide as part of induction regimen is not demonstrated, the investigator will assess the efficacy and toxicity of the combination brentuximab vedotin and chp followed by hdt/asct, as frontline treatment of eatl.

Eligibility criteria:
main inclusion criteria: 1. histologically confirmed diagnosis of eatl based on criteria established by the world health organization (who) 2016 classification of tumors of haematopoietic and lymphoid tissues. 2. eatl should be cd30-positive with a threshold of 10%. 3. patients aged ≥ 18 years and \< 70 years at the time of study entry. 4. ecog performance status 0 to 3 at time of study entry. 5. left ventricular ejection fraction (lvef) ≥ 45% measured by bidimensional echography or radionuclide ventriculography (muga scan). main exclusion criteria: 1. participants must not have been treated with any prior chemotherapy for eatl. patients with previous treatment for refractory celiac disease (i.e., immunosuppressive or immunoregulatory drugs) may be included. 2. known central nervous system involvement by eatl. 3. active chronic hepatitis b or c. 4. hiv positive serology. 5. htlv-1 positive serology.
effect of onchocerciasis elimination measures on the incidence of epilepsy in maridi, south sudan

Conditions: Onchocerciasis; Epilepsy

Summary: for the first time using a prospective design, a study confirms the results of previous retrospective studies, which found that strengthening onchocerciasis elimination efforts decreases the incidence of epilepsy, including nodding syndrome. therefore, this study confirms the solid epidemiological link between onchocerciasis and epilepsy. this study also shows that a community-based "slash and clear" vector control method can effectively decrease blackfly biting rates and potentially decrease onchocerciasis transmission. moreover, this study shows that epilepsy is a major cause of death in onchocerciasis endemic areas with high ongoing transmission.

background high onchocerciasis transmission predisposes communities in endemic areas to a high epilepsy burden. the 4·4% (95%ci:4·1-4·7%) epilepsy prevalence documented in 2018 in maridi, south sudan, motivated the strengthening of onchocerciasis elimination measures. we evaluated the effect of these interventions on the incidence of epilepsy, including nodding syndrome (ns). methods annual community-directed treatment with ivermectin (cdti) was implemented in 2019, temporarily interrupted in 2020 and reimplemented biannually in 2021. additionally, a community-based "slash and clear" vector control method was initiated in 2019 at the maridi dam. a two-stage house-to-house survey was conducted before (2018) and after (2022) implementing the interventions, consisting of initial screening by community workers to detect suspected cases of epilepsy, followed by confirmation of the diagnosis by a trained clinician. finding overall, 17,652 and 14,402 individuals participated in the pre- and post-intervention surveys, respectively. the epilepsy incidence decreased from 313·0 (95% confidence intervals (ci):273·7-357·7) to 34·7 (95%ci:17·6-66·1) per 100,000 person-years. similarly, the incidence of ns decreased from 120·4 (95%ci:96·7-149·6) to 10·4 (95%ci:2·7-33·2) per 100,000 person-years. despite biannual cdti, only 56·6% of the population took ivermectin in 2021. mortality of persons with epilepsy accounted for 17·1% (95%ci:14·0-20·7%) of the overall number of deaths in the population. interpretation in onchocerciasis-endemic areas with high prevalence of epilepsy, strengthening onchocerciasis elimination interventions can decrease the incidence of epilepsy, including ns. additional efforts are needed in maridi, where epilepsy is a major cause of mortality, to increase cdti coverage and sustain blackfly control.

Eligibility criteria:
inclusion criteria: * entire population of selected villages in maridi county exclusion criteria: * no
molecular characterization of advanced stage melanoma by blood sampling

Conditions: Metastatic Melanoma

Summary: analysis of somatic mutations in tumors is currently indicated for daily practice in all metastatic melanoma. actually, this research is limited to the mutation of three biomarkers validated by the l'institut national du cancer (inca): braf, nras and ckit. moreover, in some cases it requires invasive biopsies. in this context, molecular characterization of a tumor material flowing (circulating tumor dna and / or circulating tumor cells) could afford to benefit patients in the best conditions of current targeted therapies and future.

the main objective of this study will be to define the diagnostic sensitivity of a panel of biomarker on the circulating tumor dna from peripheral blood. the secondary objectives of this study will be: * study the concordance between mutations in circulating tumor dna and mutations in tumor tissue - study the associations between mutational profiles and clinical and histological features of melanoma. * study the prognostic impact on survival of the identified genetic profile from the circulating tumor dna

Eligibility criteria:
inclusion criteria: * patient with melanoma confirmed histologically * patient with metastatic melanoma (stage iii unresectable or stage iv) * patient consenting to participate to the study * patient enrolled in the national healthcare insurance program * patient older than 18 years exclusion criteria: - metastatic tumor whose origin is doubtful (uncertain melanoma)
to assess safety, tolerability and efficacy of ljn452 in patients with primary bile acid diarrhea.

Conditions: Primary Bile Acid Diarrhea

Summary: the purpose of this study is to determine whether ljn452 improves the symptoms of bile acid diarrhea and to assess its safety and tolerability profile in patients with primary bile acid diarrhea (pbad) to guide decision-making regarding further clinical development in this indication.


Eligibility criteria:
key inclusion criteria: * a history of diarrheal symptoms for at least 3 months prior to dosing - average stool frequency of at least 2 per day when off therapy and average stool form of \>5 on bristol stool chart. * previous laboratory or radiological confirmation of bile acid malabsorption with either fecal bile acid loss or 7 day 75selenium homocholic acid taurine (75sehcat) retention. * age ≥ 18 years. key exclusion criteria: * patients with other diagnoses leading to diarrhea, including colorectal neoplasia, ulcerative colitis, crohn's disease, celiac disease, chronic pancreatitis, drug-induced diarrhea or active infection and patients who have not been investigated by standard clinical assessments to exclude these disorders. * treatment with bile acid sequestrants (colestyramine, colestipol, colesevelam) for 2 weeks before the first dose of ljn452. a washout of 14 days for these agents will be allowed before first dosing. * women of child-bearing potential, defined as all women physiologically capable of becoming pregnant. * a positive hepatitis b surface antigen or hepatitis c test result. * history of immunodeficiency diseases, including a positive hiv (elisa and western blot) test result.

Keywords: primary bile acid diarrhea, fxr agonist, bile acid malabsorption.
extension study of original protocol aero c009 for obstructive sleep apnea-hypopnea

Conditions: Obstructive Sleep Apnea Hypopnea; Obstructive Sleep Apnea; OSAH

Summary: the purpose of this study is to evaluate the long-term durability of the treatment and safety of the provent device for those individuals who were enrolled in the c009 study, were diagnosed with obstructive sleep apnea-hypopnea (osah), and were actively using the provent device.


Eligibility criteria:
inclusion criteria: 1. based upon scoring at the study site, the 3-month 'device on' psg has a 50% reduction in ahi compared to the 1-week 'device off' psg ahi or the 3-month 'device on' psg ahi \<10 2. used the provent device at least 4 hours for at least 5/7 nights per week on average during months 1 and 2 of the three month c009 study 3. the study physician and investigator believe that continued provent use does not represent a significant safety risk for the patient 4. patient understands and is willing and able to comply with study requirements exclusion criteria: 1. the patient must continue to not meet all of the exclusion criteria of protocol c009

Keywords: obstructive sleep apnea hypopnea osa osah
effectiveness and safety of lmwh treatment in cancer patients diagnosed with non-high risk venous thromboembolism

Conditions: Venous Thromboembolism

Summary: this study is a multicenter post authorization observational study. cancer patients diagnosed with non high risk vte and are followed up in an outpatient setting will be treated with lmwh and the data will be recorded. since this is an observational study there are no specific treatment protocols, i.e., patients will be treated according to the best investigator's criteria. treatment protocol will be based on the routine treatment practice of the involved investigator. patients to enroll will be cancer patients diagnosed for vte and who are able to receive outpatient lmwh treatment. there will be no specific hypothesis to be tested.

inclusion criteria * 18 years or upper age * a signed informed consent document * cancer patient diagnosed for vte * life expectancy \> 6 months * eligible for criteria of outpatient administration of lmwh exclusion criteria • should not carry any medical situation listed below, that outpatient administration of lmwh might be risky : 1. patients with active bleeding or at-risk for bleeding 2. major surgery in the last 7 days 3. cardiopulmonary unstability 4. severe systemic venous occlusion 5. patients at high risk for pulmonary embolism 6. thrombocytopenia (\<50000/microliter) 7. inpatients under medical or surgery supervision 8. patients with low ability to communicate and for whom it is not possible to provide care at home 9. inr≥1.5 due to liver functions impairment 10. diagnosed for cerebral vascular aneurism 11. active gastric and/or duodenum ulcer 12. diagnosed for bacterial endocarditis 13. severe renal function impairment (creatinine clearance \< 30 ml/min) 14. grade 3 hypertension (dbp \>= 110 mmhg and/or sbp \>= 180 mmhg) 15. \<35 kg or ≥110 kg weight 16. known allergy to heparin and/or its derivatives 17. history of cerebrovascular event in the last 1 month 18. active haemorrhage within the last 3 months

Eligibility criteria:
inclusion criteria: * 18 years or upper age * a signed informed consent document * cancer patient diagnosed for vte * life expectancy \> 6 months * eligible for criteria of outpatient administration of lmwh exclusion criteria: * patients with active bleeding or at-risk for bleeding * major surgery in the last 7 days * cardiopulmonary unstability * severe systemic venous occlusion * patients at high risk for pulmonary embolism * thrombocytopenia (\<50000/microliter) * inpatients under medical or surgery supervision * patients with low ability to communicate and for whom it is not possible to provide care at home * inr≥1.5 due to liver functions impairment * diagnosed for cerebral vascular aneurism * active gastric and/or duodenum ulcer * diagnosed for bacterial endocarditis * severe renal function impairment (creatinine clearance \< 30 ml/min) * grade 3 hypertension (dbp \>= 110 mmhg and/or sbp \>= 180 mmhg) * \<35 kg or ≥110 kg weight * known allergy to heparin and/or its derivatives * history of cerebrovascular event in the last 1 month * active haemorrhage within the last 3 months
is neutrophil to lymphocyte ratio a prognostic factor of sepsis in newborns with operated congenital heart disease

Conditions: Sepsis Newborn

Summary: the use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery

the use of neutrophil lymphocyte ratio is useful for the detection of infection status in newborns after surgery and we compare this with other acute phase reactants

Eligibility criteria:
inclusion criteria: * newborn to be operated with the diagnosis of congenital heart disease exclusion criteria: * age older than 1 month not to be operated
effect of sedatives on regional cerebral oxygen saturation

Conditions: Cerebral Ischemia-Hypoxia

Summary: compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine sedation for spinal anesthesia in the elderly patients who undergoing femur surgery.

compare the changes of regional cerebral oxygen saturation during midazolam or dexmedetomidine administration (target bispectrl index 75-80) for spinal anesthesia in the elderly patients over 65 years who undergoing femur surgery.

Eligibility criteria:
inclusion criteria: * patinets who undergoing femur surgery under spinal anesthesia exclusion criteria: * previous cerebrovascular disease, uncontrolled cardiovascular disorder, uncontrolled pulmonary disease
effects of nordic walking in water on cerebrovascular function and cognitive impairment in elderly with type 2 diabetes

Conditions: Elderly With Type 2 Diabetes

Summary: nordic walking in water would more advantage than normal daily life in cerebrovascular function and cognitive function in elderly with type 2 diabetes.


Eligibility criteria:
inclusion criteria: * the inclusion criteria included type 2 diabetes (as defined by the american diabetes association), a baseline glycosylated hemoglobin (hba1c) value of 7-9%, and no previous exercise training in the past 6 months. all participants were free from diabetic nephropathy, diabetic retinopathy, severe diabetic neurophathy, severe cardiovascular and cerebrovascular diseases. * participants had montreal cognitive assessment - thai (moca-t) scores between 18 24 points. * participants had time up \& go test between 8 - 15 seconds exclusion criteria: * participants were excluded if they dropped out or completed less than 80% of the training schedule

Keywords: type 2 diabetes mellitus cerebrovascular function cognitive impairment nordic walking in water physical fitness
bioimpedence and arterial function monitoring at birth and in infants

Conditions: Arterial Stiffness; Fetal Growth Retardation; Small for Gestational Age at Delivery; Pre-Eclampsia

Summary: babies may be born appropriately grown for gestational age (aga, \>10th centile) or small for gestational age (sga, \<10th centile). babies who are sga and have evidence in utero of vascular compromise using antenatal doppler indices are classified as having fetal growth restriction (fgr). babies with fgr are at increased risk of cardiovascular disease in adult life. increased arterial stiffness and intima-media thickness are thought to mediate this risk in adults. it is not known how early in life these changes can be robustly detected. in addition, very little is known generally about how babies' hearts and arteries change in structure and function over the first year of life, whether affected by sga or not. this study aims to understand if there are differences in cardiac and arterial structure and function between babies born aga or sga. within the group of sga babies, the study team will investigate whether fgr and maternal pre-eclampsia influence these measurements. the effects gestational age on these parameters will be studied within all groups: half of the babies recruited will be \<32 weeks gestational age (ga), and half will be ≥32 weeks ga. study participants will have further measurements at 3-6 months of life to assess if cardiac and arterial structure and function change in babies over the first year of life. the study team will use the vicorder device to measure arterial stiffness, and assess the feasibility of using this device in neonates. the vicorder will also be used to measure cardiac output. the feasibility and validity of this device for this purpose will be investigated (vicorder is not validated for cardiac output measurement in infants). vicorder cardiac output results will be compared to echocardiography and bioimpedence technology (using the nicas monitor). the study team will use ultrasound for arterial structure measurements of the carotid artery and aorta.


Eligibility criteria:
inclusion criteria: * healthy term infants (including those with sga+/-fgr) in the postnatal ward * term and preterm infants (including those with sga+/-fgr) admitted to the neonatal unit * written informed parental consent exclusion criteria: * antenatal or postnatal diagnosis of complex/life-limiting congenital anomaly or genetic condition * infants with no realistic chance of survival * infants with fragile skin not permitting use of cuffs for research purposes * babies whose parents have a limited understanding of english will be excluded in the event that communication via nhs translation services is not possible due to clinical demands on these services
project empowering: evidence-based prep for justice-involved women and their risk networks

Conditions: HIV Infections

Summary: this study has two components. the first component is designed to assess and compare the awareness, attitudes and clinical eligibility of pre-exposure prophylaxis (prep) in criminal justice (cj) involved women. the second component is designed to evaluate the acceptability and feasibility of strategically delivering prep to cj involved women and their risk network members.

risk networks can be leveraged to maximally disseminate effective interventions to women, including prep, and thereby potentially avert some of the 50,000 annual incident hiv infections in the u.s. few studies to date have capitalized on risk networks as a way to identify and engage high-risk individuals, like cj-involved women, who could markedly benefit from prep. this study advances the field by: 1) using an innovative network-based framework (a non-traditional model of care delivery) to engage a high risk population in prep dissemination as hiv prevention; 2) incorporating a syndemic approach to prep that addresses hiv prevention in the context of substance use, psychiatric comorbidities, ipv, and stigma; and 3) recruiting, enrolling, and retaining high risk networks of cj-involved women who are difficult to reach by other means. in doing so, this proposal addresses key funding priorities of the gilead investigator sponsored research program, which includes research on prep implementation targeted to high risk populations and delivered in non-traditional clinical settings.

Eligibility criteria:
inclusion criteria: * index participants reside in, or planning to reside in new haven or hartford, connecticut,. * criminal justice-involved (anticipate release or have been released from prison or jail within 6 months, and/or are under or anticipating transfer to correctional community supervision (i.e. probation or parole)). * self-reported hiv negative. eligible and enrolled women will then recruit risk network members through respondent driven sampling, using vouchers. risk network members must: * have a unique and valid referral coupon (from index participant). * reside or planning to reside in new haven or hartford, connecticut. * self-reported hiv negative * 18 years of age or older exclusion criteria: * they are unable or unwilling to provide informed consent. * are threatening to staff.

Keywords: hiv pre-exposure prophylaxis criminal justice women risk networks
humoral and cellular immune response of herpes simplex (gd) candidate vaccines from 2 different cell lines

Conditions: Prophylaxis Herpes Simplex

Summary: the purpose of the study is to compare, in healthy hsv seronegative and hsv seropositive subjects, the humoral and cellular immune response of herpes simplex candidate vaccines containing gd from two different cell lines and using gd-alum as control.

at the time of conduct of this study, the sponsor glaxosmithkline was known by its former name smithkline beecham.

Eligibility criteria:
inclusion criteria: * between 18 and 45 years of age * written informed consent * female volunteers must be using contraception and should avoid becoming pregnant for the duration of the vaccination course * serology: groups 1, 3, 4 and 5: hsv-1 and hsv-2 seronegative (by gd2 elisa); group 2: hsv seropositive by gd2 elisa before entry exclusion criteria: * any previous vaccination against herpes simplex. * any previous administration of mpl. * pregnancy or lactation. * patient is immuno-compromised or is receiving immuno-modifying therapy of any kind. * clinical signs of acute or febrile illness at the time of entry into the study. * any administration of immunoglobulins during the vaccination course or within one month of vaccination. * any vaccination within one week of study vaccination. * previous known hypersensitivity to vaccination or to any component of the vaccine. * simultaneous participation in any other clinical trial with an investigational drug or vaccine. subjects currently in a follow-up period of a vaccine study can be included. * recent history of alcoholism or drug abuse (within the past 6 months). * life-threatening or serious cardiac (nyha grades iii-iv), gastrointestinal, hepatic, renal, hematological or immunological disorder which, in the opinion of the investigator, would preclude entry into the study.

Keywords: herpes simplex herpes simplex candidate vaccine