Kornimate/medical-research-clean huggingface dataset:
effect of extracorporeal adsorption of plasma neutrophil extracellular traps (net) in sepsis

Conditions: Sepsis; Sepsis-associated AKI

Summary: this open non-randomized controlled single center study investigates to what extent the removal of circulating neutrophil extracellular traps (nets) from blood by nucleocapture device has a positive effect on the treatment of patients with sepsis and sepsis-associated aki (sa-aki).

the term "sepsis" refers to a clinical syndrome in which a dysregulation of the host's inflammatory reaction to infection leads to a life-threatening of organ dysfunctions. sepsis and septic shock are major causes of death in intensive care units worldwide. sepsis remains the most important cause of aki in the intensive care unit (icu) with 15%-20% of patients with sepsis-associated aki (sa-aki) prescribed rrt . in addition to association with short term mortality, aki is also linked to the later development of ckd, esrd, and long-term increased risk of death netosis is a unique form of neutrophil cell death that is characterized by the release of neutrophil extracellular traps (nets) composed of dna web-like structures decorated with highly cytotoxic protein components. release of nets leads to bystander tissue damage (including the kidneys) and drives a fatal course of disease in sepsis patients. the plasmapheresis is a medical procedure, where pathogenic components are being removed from the blood by adsorbers outside the body in an extracorporeal circulation. for removal of the pathogenic substances the plasma is separated from the blood to pass the adsorber. the purified plasma is merged with the solid blood components thereafter and returned to the patient. the nucleocapture device provide highly selective removal of neutrophil extracellular traps from human blood during plasmapheresis procedure.

Eligibility criteria:
inclusion criteria: * male or female ≥ 18 and ≤ 75 years of age. * meet the clinical criteria of sepsis according to the third international consensus definitions for sepsis and septic shock (sepsis-3)) * written informed consent exclusion criteria: * a terminal state * active bleeding or uncontrolled acute massive bleeding
effect of cryolipolysis on visceral adiposity index in polycystic ovarian syndrome patients

Conditions: Polycystic Ovary Syndrome

Summary: this study will be carried to investigate the effect of cryolipolysis on visceral adiposity index in pco women randomized controlled trial

this study will be carried out on sixty females with polycystic ovarian syndrome (pcos) who were selected from the outpatient clinic of gynecology at qasr al aini university hospital. their age ranged from 17-28 years, body mass index was 25-30 kg/m2. they experienced hyperandrogenism, hyperinsulinemia and amenorrhea not less than 6 months. pcos females will be randomly assigned into two equal groups: group (a) (control group) consisted of 30 women who received low caloric diet (1200 cal/day) and group (b) (study group) consisted of 30 women who received the same diet regime and cryolipolysis

Eligibility criteria:
inclusion criteria: * age ranges from 20-28 years, body mass index ranges 25-30 kg/m2. they have pco syndrome . exclusion criteria: * diabetic patients. * women with bmi\>30 * women having circulatory dysfunction. * women with respiratory or cardiac disease * liver disease. * skin disease . * previous abdominal or uterine surgery * physical impairment
an open-label study of the safety and efficacy of atiprimod treatment for patients with advanced cancer

Conditions: Advanced Cancer

Summary: the primary objectives of this study are to identify the maximum tolerated dose and to evaluate safety of atiprimod in patients with advanced cancer.

the primary objectives of this study are to identify the maximum tolerated dose(mtd) and to evaluate safety of atiprimod in patients with advanced cancer. the secondary objectives of this study are 1) to measure the pharmacokinetics of atiprimod and 2) to evaluate the efficacy of atiprimod treatment in patients with advanced cancers and 3) to compare the pharmacokinetics of atiprimod tablets and capsules at the starting dose, with the intent of switching to capsules for the dose escalation if the capsules pose no safety issues.

Eligibility criteria:
inclusion criteria: * histological proof of advanced cancer and must have failed or relapsed following standard therapy or have no standard therapy available. * estimated life expectancy of at least 12 weeks. * must have evaluable disease. * ecog(zubrod) ps of 0 to 2 * sign informed consent. * age 13 years or more at time of signing informed consent. exclusion criteria: * renal insufficiency * concomitant radiotherapy, chemotherapy or other investigational therapies. * peripheral neuropathy grade 3 or greater (nci ctc version 3 grading) * evidence of clinically significant mucosal or internal bleeding * any condition that in the opinion of the investigator, places the patient at unacceptable risk if he/she were to participate in the study. * clinically relevant active infection or serious co-morbid medical conditions. * as atiprimod is a potent inhibitor of cyp2d6, patients taking drugs that are substrates of cyp2d6(e.g. beta blockers, antidepressants and antipsychotics will be excluded.

Keywords: cancer, atiprimod
the efficacy of vr and ar on pruritus

Conditions: Chronic Renal Insufficiency; Pruritus; Itch

Summary: the research will be conducted randomly in order to determine the effect of vr and ar on pruritus symptom.

in this study, there will be three groups: intervention group 1 with autogenic relaxation (ar), intervention group 2 with virtual reality (vr) game application and control group with routine nursing care and kidney functions narration. the number of volunteers to be included in the study was determined by power analysis. forty patients with itch symptoms will be included in each group. preliminary application for all three groups will be performed in the patient group registered to the dialysis unit of the nephrology department of hacettepe university and baskent university hospital. socio-demographic form, 5-d itch scale, dermatology life quality index, state and trait anxiety scale, pruritus behavior and sgo / or application log.

Eligibility criteria:
inclusion criteria: * receiving hemodialysis treatment for the last 6 months, * receiving four hour hemodialysis treatment three times a week, * 18-65 years of age, * experiencing pruritus for the last month. * not taking any pharmacological / non-pharmacological treatment for pruritus * no cognitive and psychiatric diagnosis, * do not use hearing aids, * open to communication and cooperation, * using smart mobile phone, * without liver disease and dermatological diseases, * patients who agree to participate in the study will be included in the study. exclusion criteria: * pregnant in the research process, * kidney transplantation, * experiencing discomfort due to virtual reality glasses, * patients who voluntarily leave the trial will be excluded from the follow-up.

Keywords: itch pruritus nursing virtual reality
efficiency and safety of zinc sulphate to reduce the duration of acute diarrheal disease between 6 and 59 months of age

Conditions: Diarrhoea;Acute; Diarrhea, Infantile

Summary: this study evaluates the effect of zinc over the duration, severity and relapse of acute diarrheic disease, in children between 6 and 59 months of age. one study group will receive a tablet that contains 20 mg of zinc, and the other study group will receive a tablet,that does not contain zinc, it is a tablet that investigators will use as control.

in mexico acute diarrheal diseases mortality in children continues to be a public health issue, being between the main causes of morbidity and mortality, with an important load for the health systems. consequently, there exists a necessity for the implementation of alternate strategies for this condition, nutrition being one of the pillars to strengthen. zinc administration during the diarrhea episode is a simple intervention for clinical picture reduction and relapse. the recommendation of including zinc in the treatment of add is not part of the mexican normativity. the evaluation of the efficacy of zinc administration in mexican children is insufficient and a program or national strategy for zinc treatment does not exist. the objective of this study is evaluates the efficacy of oral zinc sulfate administration, during the diarrhea clinic picture in children of mexico city.

Eligibility criteria:
inclusion criteria: * both sexes * children attended in the sentinel centers * clinical diagnosis of acute diarrhea disease * parents have not planned moving to other location in a time period of at least one year. exclusion criteria: * deficient intestinal absorption syndrome * acrodermatitis enterohepatic * zinc sulfate hypersensitivity * leucine metabolic disorders * secondary lactose intolerance * galactosemia lactase primary deficiency * allergy to cow milk protein * children that are supplemented with zinc for the last 6 months

Keywords: zinc sulfate children acute diarrheal diseases
intragastric balloon in compensated nash(non alcoholic steato hepatitis) cirrhotics

Conditions: Liver Cirrhosis

Summary: the study will be conducted in department of hepatology at ilbs, the patients will be recruited from the opd or ipd . the obese cirrhotic patients with nash will be observed for standard of care and also patients who undergo igb placement as part of weight reduction policy in these group of patients and will undergo an ugi endoscopy followed by placement of intragastric balloon. then the patients will be admitted for 2-3 days and followed up till 6 months.


Eligibility criteria:
inclusion criteria: * adult patients between 18 and 65 years * nash (non alcoholic steatohepatitis) cirrhosis * bmi \> 30 and failure to control weight despite full dietary and life style modifications. * compensated : ctp 6 \& 7 without any evidence of decompensation in form of hepatic encephalopathy, ascites, gi bleed or prolonged jaundice. * small varices: grade i varices exclusion criteria: * alcoholic liver disease * advanced liver disease with ascites, hepatic encephalopathy * other liver diseases such as chronic hepatitis b, chronic hepatitis c, wilsons' disease, hemochromatosis, glycogen storage diseases etc. * pregnancy * unwilling patients * large varices * past h/o gi bleed * hiatus hernia * gastric ulcer * severe esophagitis (grade b and above) * severe phg or gastric erythema
study of cerebral glucose metabolism in healthy volunteers using 18 f-fdg pet: evaluation of the effects of aging, comparative evaluation of neurodegenerative and psychiatric pathologies.

Conditions: Neuro-Degenerative Disease

Summary: the aim of the study is to obtain information on cerebral glucose metabolism measured with the 18f-fdg pet technique in normal subjects without current or previous neurological or psychiatric pathologies in order to use the data obtained for voxel-based statistical analyzes for comparison with individual subjects ( patients with disease neurological or psychiatric) which will be evaluated with the same method to improve the specificity and diagnostic sensitivity of the fdg pet exam. the objective is to obtain a functional measure of brain glucose metabolism in every normal subject because this is a functional measure of brain activity. the subjects will represent different decades of age to have a wider range of comparison with patients.


Eligibility criteria:
inclusion criteria: * absence of neurological and psychiatric pathologies, negative pregnancy test.
efficacy and safety of va106483 in elderly males

Conditions: Nocturia

Summary: a double blind, placebo-controlled, dose ranging study in males over the age of 65, who have a history of nocturia. the study will investigate pharmacodynamic outcomes (urine volumes and osmolality, circulating coagulation factors and haemodynamics) and pharmacokinetics, of both single and multiple oral doses of va106483 at three dose levels, under conditions of controlled hydration.

va106483 is a selective vasopressin v2 receptor agonist which is currently under development for the treatment of nocturia in males. this study examines the pharmacological action of va106483 on markers of clinical efficacy (urine volumes and osmolality) and safety markers (coagulation factors and haemodynamics). the study will also assess the pharmacokinetics in the study population. the study design includes both cross-over and parallel phases so that pharmacodynamic and pharmacokinetic parameters can be assessed following both single and repeat dosing. three dose levels will be given.

Eligibility criteria:
inclusion criteria: * males 65 years and above with history of nocturia exclusion criteria: * any clinically significant concomitant medical disease, condition or abnormal laboratory test result * participation in any other clinical study within 30 days * intake of non-prescription medication within 14 days
anti-parasitic activity and safety assessment of sar97276a in children with uncomplicated malaria

Conditions: Malaria

Summary: primary objective: to assess the antiparasitic activity of intramuscular (im) sar97276a based on parasite reduction ratio at 72 hours in pediatric patients with uncomplicated malaria secondary objectives: * to assess the evolution of clinical signs and symptoms (including the need for a rescue therapy) in pediatric patients with uncomplicated malaria receiving sar97276a with reference to artemisinin-based combination therapy (acts) * to assess the pharmacokinetics profile of sar97276a in pediatric patients with uncomplicated malaria * to assess the safety profile of sar97276a in pediatric patients with uncomplicated malaria * to assess the pharmacokinetic-pharmacodynamic relationship of sar97276a

the total duration per patients will last approximately 28 ± 2 days broken down as follows: * a screening phase up to 12-hours * a 28 ± 2 days study period

Eligibility criteria:
inclusion criteria: * patients diagnosed with symptomatic infection by plasmodium falciparum microscopically confirmed in blood smear at day-1 visit * fever (tympanic or rectal temperature ≥ 38 c) or documented history of fever within the last 24h * asexual parasitemia of ≥ 2 000 parasites/μl in blood smear at d-1 visit * signed informed consent form by the parents or legal guardian * age: 12 to 17 years old for step 1 * age: 2 to 11 years old for step 2 and step 3 exclusion criteria: * participation in another clinical trial within the last 3 months or participation within a different cohort in this pdy11737 clinical trial or participation to previous trial with sar97276 * documented history of adequate treatment with antimalarials expected to be effective within the preceding 72 hours * severe concomitant disease (including concomitant febrile illnesses or infection) * any sign suggestive of severe malaria * severe malnutrition * asexual parasitemia: plasmodium falciparum \> 100,000 parasites/μl in blood smear at d-1 visit * previous treatment within 3 weeks prior to inclusion, and concomitant treatment with potent cyp3a4 inhibitors or cyp3a4 inducers or cyp2d6 substrates or potent cyp2d6 inhibitors * known serious adverse event reaction or hypersensitivity to artemisinin-based combination therapy (acts) or any contraindications from the positive control therapy (artemisinin combined treatments) or warning/precaution of use as defined in the respective national product labeling * pregnant or breast-feeding women * women of childbearing potential not protected by effective contraceptive method of birth control, or not willing to use an effective contraceptive(s) method(s) for the duration of the study (e.g.: double barrier method), and/or who are unwilling or unable to be tested for pregnancy, * cpk above 3 uln, * underlying hepatobiliary disease or alt\>3 uln. the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
outcomes of digital alerting systems in secondary care

Conditions: Sepsis; Deterioration, Clinical

Summary: why? the investigators are trying to find out if participants that suddenly deteriorate on the ward can be identified sooner by wearing a wearable sensor. this is an important study to see if the sensor works correctly in recording continuous vital observations of heart rate, respiratory rate and temperature. this information can help doctors and nurses identify un-well participants. what? the investigators will ask the participants to wear a light wearable sensor on the chest that can be worn for 5 days. if the participants are still in hospital after this time the sensor can be changed. all sensors are disposable. the participants would not have to actively do anything to the sensor. we will also participants to complete a short questionnaire about the sensor. who? all participants on the ward that are admitted with a new medical or surgical problem can take part in the study. participants undergoing a surgical procedure that require at least one overnight stay are eligible to take part in this study. where? this study is being conducted at west middlesex university hospital and st marys hospital paddington. only certain wards are being included at both sites, if the participant moves wards the sensor will be removed. how? the study will last around 5 years and we aim to recruit 1000 participants.


Eligibility criteria:
inclusion criteria: * admitted adults on a general medical or surgical ward, identified as suitable by the clinical team. * able to provide written consent exclusion criteria: * pacemaker/icd * open chest wound injury * skin condition preventing sensor to be worn * participant whom withdraws consent

Keywords: vital signs continuous monitoring wearable sensor
ranibizumab intravitreal injections versus sham control in patients with branch retinal vein occlusion (brvo)

Conditions: Macular Edema Secondary to Branch Retinal Vein Occlusion

Summary: provided efficacy and safety data on intravitreal injections of ranibizumab 0.5 mg in patients with visual impairment due to macular edema secondary to brvo


Eligibility criteria:
inclusion criteria: • patients with visual impairment secondary to branch retinal vein occlusion (brvo) with a bcva between 19 and 73 letters in one eye and at least 35 letters in the other eye. exclusion criteria: * pregnant or nursing women or women of child bearing potential without unless using an effective contraception * stroke or myocard infarction within 3 months prior to study * history of malignancy within the past 5 years * uncontrolled hypertension * active infection or inflammation in any eye * use of corticosteroids for at least 30 days in the last 6 months * treatment with anti-angiogenic drugs in any eye within last 3 months * panretinal or focal/drid laser photocoagulation within the last few months

Keywords: brvo macular edema vision impairment retinal vein occlusion ranibizumab branch retinal vein occlusion anti-vegf therapy rfb002
propel randomized trial

Conditions: Stroke

Summary: it is important for people with stroke to exercise in order to improve their overall recovery and general health. however, these individuals are less physically active than people without stroke, and they often do not achieve the recommended frequency, intensity or duration of exercise. low levels of physical activity leads to people with stroke becoming very unfit, which can result in functional decline and increased difficulty being active. it is important to determine how to encourage people with stroke to be more active in the long-term. the transition time between the end of rehabilitation and return to the community might be an ideal time to address barriers, and to develop positive habits, knowledge and abilities for long-term participation in exercise. we developed the propel program that combines exercise with self-management strategies during rehabilitation to promote physical activity after rehabilitation. preliminary pilot findings indicate that people who completed propel were more physically active after discharge than those who did not. this study aims to evaluate the effect of propel on long-term participation in exercise after discharge from stroke rehabilitation. this study will take place at 6 different hospitals. participants will either complete a control intervention (group exercise only) or the propel intervention (group exercise plus self-management). participants' adherence to exercise for 6 months after the end of the interventions will be evaluated using activity and heart rate monitors and physical activity questionnaires. we expect this study will show that a simple intervention delivered during rehabilitation will increase participation in exercise after rehabilitation. increased participation in exercise could then lead to improved stroke recovery and overall health, and reduced risk of having another stroke.


Eligibility criteria:
inclusion criteria: * individuals who are referred to the group aerobic exercise or propel programs as part of their stroke rehabilitation. exclusion criteria: * language or communication barrier that prevents completion of questionnaires (e.g., severe receptive or global aphasia or non-english speaking); * cognitive impairment that would prevent participation in unsupervised exercise; * attend less than 50% of group aerobic exercise/propel sessions; and/or * attend less than 4 of the 6 group discussion sessions (for individuals referred to the propel program).

Keywords: physical activity exercise behaviour change rehabilitation self-management education
the role of the circadian system in neurological sleep-wake disorders

Conditions: Narcolepsy 1; Idiopathic Hypersomnia

Summary: the aim of this study is to investigate the role of the circadian system in patients with neurologic sleep-wake disorders. therefore, overnight sleep will be distributed over 30 hours into repetitive sleep-wake cycles (poly-nap protocol), so that sleep episodes occur at different circadian phases. vigilance, attention, risk behavior as well as sleep onset latency will be observed. ambulatory accelerometer recordings gain more and more attention in the diagnostic work-up of sleep disorders, as they allow to also include the everyday rest-activity rhythm before examinations in the sleep laboratory. advances of novel devices should improve the detection of rest and activity and therefore the estimation of sleep and wake, especially in patients with neurologic sleep-wake disorders exhibiting fragmented sleep. two types of actimeters will be applied throughout our study protocol to explore better classification of sleep and wake phases and patterns of the rest-activity rhythm. this study is designed as an observational case-controlled study targeting the disorders of narcolepsy type 1 and idiopathic hypersomnia, and including interventional procedures in the healthy control group (sleep deprivation, sleep restriction) in a counter-balanced design.


Eligibility criteria:
inclusion criteria: * male and female participants 18 years to 35 years of age * written informed consent by the participant after information about the research project * healthy controls: 7-8 hours of sleep per night * healthy controls: sleep satiation before start of the study * narcolepsy type 1: diagnosis of narcolepsy with cataplexy, drug free during study, proven excessive daytime sleepiness with increased rem (mslt), clear-cut cataplexy present, undetectable or low cerebrospinal fluid hypocretin levels (if data is available) * idiopathic hypersomnia: diagnosis of idiopathic hypersomnia, drug free during study, proven excessive daytime sleepiness without increased rem (mslt), increased sleep need (\>10h/day) on work-free days shown by 2-week actigraphy exclusion criteria: * signs of neurological, psychiatric, or other sleep-wake disorders * signs of sleep deprivation * shift work and time zone change of more than one hour within one month prior the study start * extreme morning and evening types * underweight * obstructive gastro-intestinal disease or history of gastrointestinal surgery * an implanted medical device or a scheduled mri scan during the experimental period