Kornimate/medical-research-clean huggingface dataset:
stellate ganglion block on tourniquet response

Conditions: Stellate Ganglion Block

Summary: to investigate the influence of stellate ganglion block on tourniquet response during surgery in patients undergoing elective lower limb department of orthopedics.

select elective general anesthesia in 100 cases of lower extremity department of orthopedics surgery patients were randomly divided into sgb group and control group, sgb group received anesthesia before the right stellate ganglion block intervention, the control group underwent right deltoid muscle injection, changes in hemodynamics in two groups were recorded in heart rate, blood pressure, and before anesthesia, after intubation 3min 1h, a tourniquet, tourniquet release before and after tourniquet release 3min, 30min, changes in blood physiological analysis. the effect of stellate ganglion block on tourniquet response during perioperative period was observed.

Eligibility criteria:
inclusion criteria: * american society of anesthesiologists grade 1-3 patients * undergoing lower limb surgery under general anesthesia * should be treated with tourniquet exclusion criteria: * tourniquet application time is less than 1h, greater than 1.5h * abnormal coagulation function * perioperative application of hormone * lidocaine allergy * can not cope with nerve block * nerve block failure * minimally invasive surgery

Keywords: stellate ganglion block tourniquet reaction
subject variability in two lots of e5501 administered to fed and fasted healthy subjects

Conditions: Purpura, Thrombocytopenic, Idiopathic; Acute Idiopathic Thrombocytopenic Purpura; Chronic Thrombocytopenia

Summary: this will be a randomized, open-label, four-group, two-period, replicate design study to evaluate the effect of food on within and between subject variability in second generation formulation 20-mg tablet strengths, lots p01008zza and p01009zza, administered as single doses of 40mg to 84 healthy male and female subjects. the study is powered to detect both a reduction in either the within or between subject variability (coefficient of variation \[cv\]%) of approximately 35%.

this is a phase 2, multi-center, double-blind, randomized, placebo-controlled, dose-ranging, parallel-group study. the pk and pk/pd relationship of akr-501 will also be studied. approximately 65 eligible patients will be randomized in a 3:3:3:3:1 ratio in a double-blinded fashion into one of five parallel treatment groups to receive daily doses of either akr-501 2.5, 5, 10 or 20 mg or placebo for 28 days, respectively. each akr-501 dosing group will consist of 15 patients while the placebo group will consist of 5 patients. all study patients will be evaluated weekly (days 3, 5, 7, 14, 21 and 28) for safety, efficacy, and (days 7, 14, 21, and 28) akr-501 pharmacokinetics while receiving study treatment with a final assessment for safety and effectiveness to be done 2 weeks after the last study dose (day 42).

Eligibility criteria:
inclusion criteria: * normal healthy male or female subjects age greater than or equal to 18 years and less than or equal to 55 years * body mass index greater than or equal to 18 and less than or equal to 32kg/m2 at screening * platelet count greater than or equal to 120x109/l and less than or equal to 250x109/l * women of childbearing potential must agree to use a highly effective method of contraception, other than estrogen-based hormonal contraceptives, during the randomization phase of the study exclusion criteria: * evidence of clinically significant cardiovascular, hepatic, gastrointestinal, renal, respiratory, endocrine, hematologic, neurologic, or psychiatric disease or abnormalities or a known history of any gastrointestinal surgery that could impact pk of the study drug * agents associated with thrombotic events (including oral contraceptives) must be discontinued within 30 days of first study drug administration * evidence of organ dysfunction or any clinically significant deviation from normal in their medical history, e.g., history of splenectomy * history of venous or arterial thrombotic disease or other hypercoaguable state * hemoglobin less than lower limit of normal (lln) levels (females 7.1 mmol/l, males 8.1 mmol/l

Keywords: idiopathic thrombocytopenia purpura(itp) acute and chronic thrombocytopenia associated with chronic liver disease tld
cognitive processing therapy versus prolonged exposure for treating women with post-traumatic stress disorder brought on by sexual assault

Conditions: Post-Traumatic Stress Disorder

Summary: this study will evaluate the effectiveness of cognitive processing therapy versus prolonged exposure therapy in treating women with post-traumatic stress disorder (ptsd) brought on by sexual assault.

ptsd is a psychiatric disorder that can occur following exposure to a traumatic event in which grave physical harm occurred or was threatened. ptsd is marked by clear biological changes as well as psychological symptoms. many people with ptsd repeatedly relive the trauma in the form of flashback episodes, memories, nightmares, or frightening thoughts. this study will evaluate the effectiveness of cognitive processing therapy (cpt) versus prolonged exposure therapy in treating women with ptsd brought on by sexual assault. participants in this single-blind study will be randomly assigned to one of three conditions: cpt, prolonged exposure therapy (pe), or minimal attention (ma). individuals assigned to receive cpt will attend therapy sessions twice weekly for 6 weeks. each session will be 1 hour long, except for sessions 4 and 5, which will be 1.5 hours long. cpt will focus on helping each individual to process accurate memories of the traumatic event and to work through any memories that cannot be completely ignored, nor completely integrated back into their thinking. also included in cpt will be an exposure component, in which participants will be encouraged to recall the traumatic event and experience any emotions connected to it. participants assigned to receive pe therapy will attend an initial 1-hour therapy session, followed by 4 weeks of additional sessions that will meet twice weekly. each of these 8 sessions will be 1.5 hours long. pe will entail oral exposure without modification of the participant's cognitions. participants will discuss their traumatic experiences in detail during each session to aid in emotional processing. all pe sessions will be audio taped. participants will listen to the tapes of their sessions on their own to further assist with emotional processing. individuals assigned to receive ma will receive no therapy for the first 6 weeks. at the end of this initial phase, they will be assigned to receive either cpt or pe if they still meet diagnostic criteria for ptsd. symptoms of ptsd, feelings of guilt and shame, and overall perception of self and surroundings will be assessed at baseline, post-treatment, and at follow-up visits at 3, 6, and 9 months post-treatment.

Eligibility criteria:
inclusion criteria: * history of at least one incidence of rape * diagnosed with post-traumatic stress disorder exclusion criteria: * rape occurred before the age of 13 and was committed by a family member * rape was committed by a spouse who is currently living in the same household * psychosis * mental retardation * current pathology that may complicate symptoms of post-traumatic stress disorder * currently suicidal or parasuicidal * currently addicted to drugs or alcohol * illiterate

Keywords: cognitive therapy ptsd females rape trauma
a study to see if an iphone weight management app can help promote weight loss in adolescents and young adults after a stem cell transplant

Conditions: Obesity; Malignant Neoplasm

Summary: this early phase i trial studies how well a behavioral weight loss intervention consisting of a smartphone application and coaching works for the promotion of weight loss in adolescents and young adults after a stem cell transplant. this study may help researchers learn more about how adolescents and young adults can lose weight and develop healthy eating habits.

primary objective: i. to evaluate the effectiveness of an addiction-based weight loss intervention, embodied as a smartphone application (app) with telephone coaching, on weight outcomes of overweight and obese post hematopoietic stem cell transplantation (hsct) adolescents and young adults. secondary objectives: i. to evaluate the changes in metabolic parameters and physical activity levels, in addition to modifications in addictive eating behaviors, motivation, and self-regulatory behaviors. ii. to evaluate the feasibility, adherence, and satisfaction of this intervention. outline: patients receive an iphone with w8loss2go app, a body scale and a digital food scale to weigh themselves and food daily. patients interact with coaches via text messages for 4 days weekly and receive weekly 15 minute phone calls for appointment reminders, emotional support, progress discussion, and follow up on items discussed in a prior visit or phone call. patients also have telemedicine interviews with the coach lasting 60 minutes at 2 and 4 months to elicit both positive and negative impacts on weight management and to identify barriers such as emotional eating, displacement behaviors, poor coping skills to life stressors, and social challenges. patients who opt to extend the intervention until month 12 attend an additional telemedicine meeting with the coach. patients also complete questionnaires over approximately 1.5 hours.

Eligibility criteria:
inclusion criteria: * patients with a history of hsct of any type, at least 100 days post-transplant at initial consultation of the study, will be eligible for the study * patients must classify as obese, represented as body mass index (bmi) \>= 85th percentile for age and gender * patients must also be able to read english since the app intervention is only available in english form * no patients will be excluded for any specific underlying medical condition, but decisions will be made on a case by case basis if a patient's functioning is deemed to significantly interfere with intervention participation * parent: * his/her child meets all inclusion criteria * \>= 18 years of age * can speak english exclusion criteria: * patients who are \ 100 days post-transplant at their next consultation that falls within the enrollment window * patients whose bmi does not fall under the obese category will be excluded
a study of cardiac arrhythmia and ecg changes in children with convulsions at sohag university hospital

Conditions: Convulsions

Summary: convulsion is a common pediatric disorder and there is strong relation between convulsion and cardiovascular system which revealed by ecg monitoring and there are many ecg abnormalities attributed to different causes of convulsions, a 12-lead ecg is a low-cost test and can detect clinically significant abnormalities such as long qtc interval or heart block. doing an ecg in all patients presenting with seizures clinic, inevitably, pick up non-specific abnormalities which require further investigation. moreover, a normal 12-lead ecg does not exclude a cardiovascular cause for collapse and for those in whom a cardiac cause is still suspected despite a normal ecg, referral to a cardiologist is advisable


Eligibility criteria:
inclusion criteria: * all children aged from 1month to 18 years presenting to the pediatric emergency with convulsions will be included. exclusion criteria: * children not filling the criteria of convulsions (like conditions mimic epilepsy) * children with known cardiac disease or cardiac arrhythmia and patients who will not give consent will be excluded.
effects of environmental opportunities and barriers on physical activity, fitness, and health in hispanic children in wisconsin

Conditions: Obesity, Diabetes, Nutrition, Physical Health

Summary: this is a pilot community-based research study to examine the effects of specific environmental and social factors on physical activity, fitness, and health of middle school hispanic children living in an inner-city community.

our primary hypothesis is that the disparity between a community's potential for physical activity and nutrition, and the realized fitness and health of its children, can be attributed to specific environmental and social factors. "built environment" studies to date have measured potential for physical activity but have not looked at how social factors mediate an individual's activity within a particular environment. the unique aspect of this proposal is the development of a model that explains how physical, social, cultural, and nutritional sem layers interact to create gaps between potential and realized physical activity. this project will utilize novel technologies to: 1. identify and analyze characteristics of the social and built environment that inhibit or enhance physical activity and healthy nutrition; 2. determine the direction and extent of influence of these variables on children's activity, nutrition, and health; 3. gather ideas from students, parents, and school staff to inform a potential health campaign to reduce and prevent obesity in the community. to address these goals and demonstrate a causal relationship between physical activity and the social-nutritional factors within a built environment, the following specific objectives/aims are being addressed: specific aim 1: assess the built environment for energy requirements of movement, nutrition options, suitability for outdoor physical activity, and for children's actual physical activity and energy expenditure within those environments. specific aim 2: assess the impact of children's social environment on movement and nutrition choices within the built environment. specific aim 3: conduct a quantitative assessment of children's fitness, obesity, and indicators of metabolic health. specific aim 4: develop a quantitative model from specific aims 1-3 that describes the causal relationships among children's physical health, community "healthfulness," and other mediating factors such as attitudes, perceptions, and behavior.

Eligibility criteria:
inclusion criteria: 1. the child is in academic attendance at the bgcs in grades 5-8 and cherokee middle school in grades 6-8. 2. the child and parent or legal guardian is able to provide assent and/or consent. 3. the child is able to understand instructions for study-related activities and comply exclusion criteria: 1. the child is not in academic attendance at the bgcs in grades 5-8 or at cherokeed middle school grades 6-8 2. the child and parent or legal guardian is not able to provide assent and/or consent. 3. the child is able to not able to understand instructions for study-related activities and comply -

Keywords: obesity, diabetes, hispanic, physical activity, nutrition
dose-finding study to investigate the safety and immunogenicity of two vaccinations with fsme immun new in healthy volunteers aged 1 to 6 years.

Conditions: Tick-borne Encephalitis

Summary: the purpose of this study is to investigate the safety and immunogenicity of three different concentrations of a tbe vaccine in healthy children aged 1 to 6 years.


Eligibility criteria:
inclusion criteria: male and female children will be eligible for participation in this study if: * they are 1 year (from the 1st birthday) to 6 years (to the last day before the 6th birthday) old; * they are clinically healthy; * their legal representative understands the nature of the study, agrees to its provisions and gives written informed consent; * their legal representative agrees to keep a volunteer diary. exclusion criteria: children will be excluded from participation in this study if they: * have a history of any previous tbe vaccination; * have a history of tbe infection or show evidence of a latent tbe infection (as demonstrated by screening elisa \> 126 vieu/ml and / or neutralization test \> 1:10); * have a history of allergic reactions, in particular to one of the components of the vaccine; * have received antipyretics within 4 hours prior to the first tbe vaccination; * suffer from a disease that cannot be effectively treated or stabilized; * suffer from a disease (e.g. autoimmune disease) or are undergoing a form of treatment that can be expected to influence immunological functions; * suffer from chronic, degenerative and / or inflammatory disease of the central nervous system; * are known to be hiv positive (a special hiv test is not required for the purpose of the study); * suffer from a febrile illness at study entry; * have a history of vaccination against yellow fever and / or japanese b-encephalitis; * are participating simultaneously in another clinical trial.
real world experience in heart failure with reduced ejection fraction (hfref) patients treated with sac/val.

Conditions: Heart Failure

Summary: the study is a cohort observational, retrospective, non-interventional study.

study period: index date: the index date were defined as the first date of the first prescription of sacubitril/valsartan during inclusion period and this were used to establish the beginning of the follow-up period. characterization period: 6 months period before the index date were used to characterize patients. follow-up period: any patients has at least 1 year of follow-up. follow-up period went from index date to june 2020.

Eligibility criteria:
inclusion criteria: consecutive ambulatory patients with a diagnosis of hf that attended the outpatient clinics for hf management and who have been prescribed sacubitril/valsartan from 01 october 2016 to 30 june 2019 (inclusion period) were included in the study. to allow for at least 1-year follow-up period for any patients, the observation period ended by 30 june 2020. in detail, all patients attending by outpatient clinics for the diagnosis and treatment of hf in the italian centers involved, with: * age ≥18 years old and * at least one prescription of sacubitril/valsartan from 01 october 2016 to 30 june 2019 were included in the study. exclusion criteria: * missing age or sex information.

Keywords: drug utilization, heart failure, real-world, sacubitril/valsartan
a comparative efficacy and safety study of nexium delayed-release capsules (40mg qd and 20mg qd) versus ranitidine 150mg bid for the healing of nsaid-associated gastric ulcers when daily nsaid use is continued

Conditions: NSAID Associated Gastric Ulcers

Summary: nonsteroidal anti-inflammatory drugs (nsaids) are often associated with gastric ulcers. this study looks at the treatment of these gastric ulcers with one of the three following treatment groups: esomeprazole 40 mg once daily; esomeprazole 20 mg once daily; or ranitidine 150 mg twice daily.


Eligibility criteria:
inclusion criteria: 1. a clinical diagnosis of a chronic condition (eg osteoarthritis or rheumatoid arthritis) that requires daily nsaid treatment for at least 2 months. 2. other key inclusion criteria, as specified in the protocol. exclusion criteria: 1. history of esophageal, gastric or duodenal surgery, except for simple closure of an ulcer. 2. history of severe liver disease, including (but not limited to) cirrhosis and acute or chronic hepatitis. 3. other conditions and criteria, as specified in the protocol.

Keywords: nsaid nexium esomeprazole gastric ulcers
functional reserve estimation of donor kidney

Conditions: End-stage Renal Disease

Summary: the purpose of the study: * to estimate the role of morphological, clinical, biochemical and imaging studies at stages of kidney transplantation (medical therapy, explantation, preservation, transplantation). * to improve the ways of preserving optimal functional parameters of renal transplants.

terminal chronic renal failure (esrd) as a result of almost any chronic kidney disease develops due to progressive loss of nephrons. this state is characterized by a gradual deterioration of the functional abilities of not only the kidneys, but also the whole body. currently, esrd is among the first ten causes of mortality . transplantation of donor organs is the only radical treatment for various diseases of the terminal, for patients with a fatal prognosis. kidney transplantation has allowed not only save lives, but also to return to normal life, tens of thousands of people. survival of renal transplant recipients is growing. despite the progress made in many clinics worldwide in recent years in the field of transplantation, kidney transplantation, does not settle the problem of reperfusion injury and the associated post-transplant dysfunction with the absence of clear indicators of morphological, clinical, biochemical and instrumental methods to assess functional reserve of organs that remain relevant and meaningful.

Eligibility criteria:
inclusion criteria: * recipients-patients with end-stage renal disease; * donor healthy people without absolute contraindications to the kidney transplantation; * donor and recipients who are both in the genetic and non-genetic related to each other. * obligatory immunological compatibility by hla-phenotyping provided that the donor and recipient are not relatives with each other; * negative result of cross-match between donors and recipients; * presence of pre-existing lymphotoxic antibodies in a recipient less than 50%; * absence of standard absolute contraindications in a donor and in a recipient for surgeric intervention. age is 18-60 years. exclusion criteria: * patients with absolute contraindications to surgery: diseases of organs and systems having a threating risk to the life of donor and recipient during and after surgery; * immunological incompatibility between donor and recipient; * high level of pre-existing lymphotoxic antibodies in a recipient more than 50%, uncorrected by therapy; * donor age is under 18 and over 60 years; * incapable persons; * absence of a notarized consent form to kidney transplantation; * presence of the active phase of viral infection with hepatitis b and c; * positive results of blood tests for hiv/aids, syphilis; * patients with severe concomitant pathology of kidneys, (or) heart and (or)liver.

Keywords: kidney transplantation,functional status,survival.
radiographic migration analysis of the attune cementless cr fixed-bearing total knee replacement

Conditions: Osteo Arthritis Knee

Summary: this is a multi-centre, single cohort trial of patients undergoing cruciate-retaining total knee arthroplasty with the attune cementless, fixed bearing, cruciate retaining tka system.

all patients will undergo post-operative radiostereometric analysis (rsa) and computed tomography (ct) to quantify and characterize the in vivo migration pattern of the attune affixium cementless tibial baseplate and the attune porocoat cementless femoral component up to 24 months. patient health and functional outcomes will be recorded at pre- and post-operative intervals for all patients. peri-operative adverse events and other clinical complications will be captured as encountered.

Eligibility criteria:
inclusion criteria: * symptomatic osteoarthritis of the knee indicating primary total knee arthroplasty * patients aged 21 years or older * sufficient ligamentous function to warrant retention of the posterior cruciate ligament * patients willing and able to comply with follow-up requirements and self-evaluations * ability to give informed consent exclusion criteria: * active or prior infection of ipsilateral extremity * medical condition precluding major surgery * inflammatory arthropathy * posterior cruciate ligament (pcl) deficiency * major coronal plane deformity * conditions that are cautioned against or contraindicated, as listed in the product monograph and/or instruction for use * bone defects requiring augments, cones and/or stemmed implants