Kornimate/medical-research-clean huggingface dataset:
a mobile application to improve postoperative outcomes in colorectal cancer

Conditions: Colorectal Cancer; Surgery

Summary: the unplanned readmission rate after colorectal cancer surgery is still high, despite the implementation of enhanced recovery programs. the use of a mobile-based application for perioperative remote monitoring may improve the postoperative outcomes and reduce the unplanned postoperative readmissions.

despite the implementation of enhanced recovery programs, the rate of unplanned readmissions remains high after colorectal cancer surgery. these readmissions are often preventable with a better postoperative management. increasing studies have demonstrated the feasibility and efficacy of perioperative remote monitoring mobile applications in improving the postoperative outcomes but are often limited to one restricted outcome. this project aims to evaluate the effect of the care 4 today® (johnson \& johnson) perioperative mobile app on the postoperative outcomes of colorectal cancer patients, with a focus on unplanned readmissions.

Eligibility criteria:
inclusion criteria: * patients aged more than 18 years old. * patients scheduled for elective curative colorectal resection, including right (or extended) colectomy, left colectomy, rectal resection (with or without ileostomy), total colectomy, recanalization, or multiple colon resection. * patients willing to comply with the study procedures. * proficient understanding of the italian language exclusion criteria: * any condition that, in the opinion of the investigator, may interfere with the study procedures. * patients scheduled for palliative surgery. * patients with a planned elective intervention requiring urgent or emergent surgery will be withdrawn from the study. * pregnant or breastfeeding women. * inability to comply with the study procedures.

Keywords: colorectal cancer surgery mobile app unplanned readmissions
efficacy of eptifibatide compared to abciximab in primary percutaneous coronary intervention (pci) for acute st elevation myocardial infarction (stemi)

Conditions: Infarction, Myocardial

Summary: multinational, multicentre, randomised, prospective, open, parallel group study directly comparing two glycoprotein-iib/iiia inhibitors, abciximab and eptifibatide, added early to standard treatment before primary pci of stemi patients with respect to effect on sum-st-resolution after 60 minutes post-procedure and other measures of myocardial reperfusion


Eligibility criteria:
inclusion criteria: * women must be postmenopausal (i.e.12 months without menstrual period), or surgically sterile, i.e. women of child bearing potential are not allowed to be included into the study. in cases of doubt a pregnancy test should be performed. (nb -post menopausal women currently receiving hormone replacement are permissible) * acute myocardial infarction \< 12 h defined as: 1. angina or equivalent symptoms \> 20 min and 2. st elevation in 2 contiguous ecg leads (= 2 mm precordial lead, = 1 mm limb lead). this ecg recording serves as baseline ecg, i.e. ecg i. * planned primary percutaneous coronary intervention * the subject has given written informed, dated consent to participate in the study exclusion criteria: * subjects not able to give informed consent * left bundle branch block * thrombolytic therapy within 24 hours before randomization * oral anticoagulation with international normalized ratio (inr) \> 2 * known platelets \< 100.000/µl or known hemorrhagic diathesis * stroke or transient ischemic attack (tia) within the past 6 months or any permanent residual neurological defect * evidence of an active gastrointestinal or urogenital bleeding * major surgery within 6 weeks * history of allergic reaction to abciximab or eptifibatide or any component used in the study (including contrast media) * known severe renal (creatinine clearance \<30ml/min) or hepatic insufficiency as well as alanine transaminase (alt)/aspartate transaminase (ast) elevations = 3xupper limit normal (uln); isolated ast-elevation is not considered an exclusion criteria from study participation * severe concomitant disease with life expectation \< 1 year * subject has participated in any study using an investigational drug or device within 30 days or within 5 half-lives of the investigational drug (whichever is longer) of entry into this study. * subjects who will be inaccessible due to geographic or social factors during treatment or follow-up * in france, a subject is neither affiliated with nor a beneficiary of a social security category.

Keywords: eptifibatide st-elevation myocardial infarction stemi abciximab
2015-metabolomics&microbiome-infertility

Conditions: Azoospermia, Nonobstructive

Summary: the study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition.

the study aims to carry out a translational analysis of the microbiome and metabolomics in patients suffering from non-obstructive azoospermia, with the aim of investigating prognostic factors predictive of the possible finding of spermatozoa following testicular pulp extraction and differences in blood and seminal level with the fertile population to identify etiopathogenic pathways of this condition. furthermore, the study aims to assess if the blood and seminal alterations of infertile patients have similarities with the same fluids of elderly patients, validating from a metabolomic and microbiomic point of view the hypothesis of premature aging of infertile patients.

Eligibility criteria:
inclusion criteria: * diagnosis of idiopathic non-obstructive azoospermia * fertile men (pregnancy within 12 months from the start of the couple's search) * men known to have been fertile aged between 65 and 75 (pregnancy within 12 months of the couple starting searching) exclusion criteria: * diagnosis of varicocele * endocrine alterations * chromosomal alterations * known genetic alterations
effects of antipsychotic medications on energy intake and expenditure

Conditions: Schizophrenia; Schizoaffective Disorder; Weight Gain

Summary: aim 1: to evaluate the effect of antipsychotic treatment group on activity energy expenditure. the project hypothesizes that subjects treated with olanzapine will demonstrate a greater decrease in aee over time than subjects treated with ziprasidone, due at least in part to sedating effects of olanzapine. aim 2: to evaluate the effect of antipsychotic treatment group on energy intake. the project hypothesizes that subjects treated with olanzapine will demonstrate a greater increase in ei over time than subjects treated with ziprasidone, based on higher histamine type 1 (h1) receptor affinity of olanzapine and the relationship between h1 affinity and hunger and/or satiety.

the overall purpose of this research is to determine how two commonly prescribed antipsychotic medications, olanzapine (zyprexa) and ziprasidone (geodon), affect weight gain through increasing appetite and/or through increasing sedation that results in decreased activity. undesirable changes in body weight, blood sugar control, type 2 diabetes, and blood lipids occur more commonly in people who have schizophrenia than in people without psychiatric conditions. although differences in glucose regulation were first reported in schizophrenia before the use of antipsychotic medications, antipsychotic treatment may contribute to these problems, though just how this happens is not understood. this study proposes to use a doubly-labeled water (dlw) method to measure the degree to which weight gain (fat mass) is due to increased appetite, decreased physical activity from being tired and sleepy, or some combination of both. doubly-labeled water contains stable isotopes (non-radioactive forms) of the hydrogen and oxygen that make up all water, isotopes that will be slowly passed out through the urine after participants drink dlw. the number of hydrogen and oxygen isotopes found in the urine samples will tell us how many calories the participant's body has been using. the dlw method has been used in people with obesity and other types of medical problems. it's recognized as the most accurate measure of the number of calories burned throughout a typical day, and how many calories are taken in from food and drink. by measuring these factors in people who take antipsychotic medications, doctors will gain a better understanding of the effects of antipsychotic medications on body weight and fat mass. this could lead to the development of better ways to prevent or treat weight gain or diabetes in patients who take antipsychotic medications.

Eligibility criteria:
inclusion criteria: * non-diabetic * schizophrenic or schizoaffective * currently prescribed olanzapine or ziprasidone * 18-80 y.o. exclusion criteria: * \ 80 years of age * diabetic * not schizophrenic or schizoaffective * not currently prescribed olanzapine or ziprasidone

Keywords: energy expenditure schizophrenia
a clinical trial to confirm safety & effectiveness of the synergy 4.50 mm and 5.00 mm stent for treatment of atherosclerotic lesion(s)

Conditions: Atherosclerosis; Heart Diseases, Coronary; Coronary Artery Disease; Cardiovascular Diseases

Summary: evolve 4.5/5.0 is a prospective, single-arm, multi-center observational (standard of care) trial intended to confirm the safety and effectiveness of the synergy 4.50 mm and 5.00 mm coronary stent system for the treatment of patients with coronary artery disease in large vessels (≤ 28 mm in length, by visual estimate, in native coronary arteries \> 4.00 mm to ≤5.00 mm in diameter, by visual estimate). this post approval study is a cohort associated with the synergy megatron post approval study, which is registered under clinicaltrials.gov id: nct04807439.


Eligibility criteria:
inclusion criteria: * a patient is an acceptable candidate if they require treatment with a 4.50 or 5.00 mm synergy stent for the treatment of their disease in accordance with the applicable guidelines on pci, the synergy dfu, and the declaration of helsinki. exclusion criteria: * planned treatment with a non-synergy stent.

Keywords: drug-eluting stents
validation of a novel frailty index in surgical cohorts

Conditions: Surgery--Complications; Anesthesia Morbidity; Perioperative Complication

Summary: this study will validate the utility of a novel frailty index that uses icd diagnoses to call frailty severity in a surgical cohort of patients 65 and older


Eligibility criteria:
inclusion criteria: * patients 65 years or older, undergoing any surgery at landspitali university hospital with an anesthesia team involved exclusion criteria: * no american society of anesthesiology classification provided
an exploratory trial using semg to differentiate pnes from epileptic seizures

Conditions: Non-Epileptic Seizure; Motor Seizure; Epilepsy

Summary: this is an observational study of subjects receiving standard of care therapy, while admitted to epilepsy monitoring unit, department of neurology, general hospital hietzing with neurological center rosenhügel. additional monitoring provided by the speac system will be compared to the gold standard, veeg. the speac system is being evaluated while being used in adjunct to standard of care.


Eligibility criteria:
inclusion criteria: 1. subject has a suspected history of pnes with upper extremity motor involvement or epileptic seizures with upper extremity motor involvement. 2. is being admitted to a hospital for routine veeg monitoring related to seizures. 3. male or female between the ages of 18-99. 4. if female and of childbearing potential, has a negative pregnancy test. 5. can understand and sign written informed consent prior to the performance of any study assessments. 6. subject must be competent to follow all study procedures. exclusion criteria: 1.intracranial eeg electrodes are being used.
a study evaluating the safety and efficacy of vx-659 combination therapy in subjects with cystic fibrosis

Conditions: Cystic Fibrosis

Summary: this is a phase 2, randomized, double-blind, placebo- and tezacaftor/ivacaftor (tez/iva)-controlled, parallel-group, 3-part, multicenter study designed to evaluate the safety and efficacy of vx-659 in triple combination (tc) with tez and iva in subjects with cystic fibrosis (cf) who are homozygous for the f508del mutation of the cf transmembrane conductance regulator (cftr) gene (f/f genotype), or who are heterozygous for the f508del mutation and a minimal function (mf) cftr mutation not likely to respond to tez, iva, or tez/iva (f/mf genotypes).


Eligibility criteria:
key inclusion criteria: * body weight ≥35 kg. * subjects must have an eligiblecftr genotype. * part 1 and part 3: heterozygous for f508del and an mf mutation (f/mf) * part 2: homozygous for f508del (f/f) * fev1 value ≥40% and ≤90% of predicted mean for age, sex, and height key exclusion criteria: * history of clinically significant cirrhosis with or without portal hypertension. * glucose-6-phosphate dehydrogenase (g6pd) deficiency * lung infection with organisms associated with a more rapid decline in pulmonary status. * history of solid organ or hematological transplantation. other protocol defined inclusion/exclusion criteria may apply.
the impact of a heart failure review on self-care knowledge, adherence and clinical outcomes

Conditions: Heart Failure

Summary: this study is assessing the effects of a new heart failure self-care education program in the nebraska heart institute heart improvement clinic. the new education program will consist of an initial intensive self-care education session with the principal investigator or her nurse practitioner. topics to be discussed include medications, sodium and fluid consumption, alcohol restriction, exercise, preventive behaviors, and monitoring of signs and symptoms. as recommended in the accf/aha guidelines, this education will be repeated on an annual basis as studies have shown that the impact of hf education is not always durable and must be a continual process. this study will assess the impact of this review on their medication knowledge, disease state knowledge, quality of life, disease state progression and clinical outcomes such as ejection fraction and number of hospitalizations.

this is an observational study as all patients in the heart failure clinic, regardless of whether or not they will choose to be in the study, will receive heart failure self-care education from now on.

Eligibility criteria:
inclusion criteria: * males and females ages 19 and older * able to speak, read and understand english and able to understand and provide informed consent * diagnosis of cardiomyopathy and/or hf, preserved or reduced ejection fraction exclusion criteria: * patients not-responsible for self-care. * inability to provide written informed consent. * co-morbid condition with an expected survival of less than six months.
management of slipped capital femoral epiphysis (scfe) on top of fixed fracture neck of femur case report.

Conditions: Slipped Capital Femoral Epiphysis

Summary: slipped capital femoral epiphysis (scfe) on top of fixed fracture neck of femur managed by subtrochanteric valgus osteotomy

the incidence of slipped capital femoral epiphysis (scfe) after management of femoral neck fracture in pediatrics is very rare. in this case report, a 9-year-old female child sustained left sided femur neck fracture after a motor car accident. the fracture was fixed by two cannulated screws and healing with mild varus occurred after 1.5 months. however, progressive slippage of femoral epiphysis was observed. this was treated by subtrochanteric valgus osteotomy

Eligibility criteria:
inclusion criteria: * scfe on top nof exclusion criteria: * pathological fracture

Keywords: slipped capital femoral epiphysis scfe coxa vara fracture neck of femur
global impact of covid-19 on pulmonology special units

Conditions: Covid19; Global Impact; Pulmonology

Summary: the covid-19 pandemic is having a profound impact on the world. as of may 18, 2020, there were 4,889,287 confirmed cases and 322,683 deaths globally. the healthcare system is wrestling with a virus that threatens to overwhelm hospital capacity, while simultaneously confronting an unprecedented reduction in elective and non-essential care. a survey by the american cancer society showed that 50% of cancer patients and survivors reported some impact to their healthcare due to the covid-19 epidemic. a recent survey was conducted by forbes et al to evaluate the changes in gi and endoscopy practices in north america. however, the impact of this epidemic on pulmonology units ( bronchoscopy, thoracoscopy, ultrsonography and sleep lab) globally has not been studied.


Eligibility criteria:
inclusion criteria: * working registered invited pulmonology units; governmental, university, private exclusion criteria: * non pulmonary medicine registered units

Keywords: bronchoscopy thoracoscopy thoracic ultrasonography sleep lab global impact
specifying interventions from the sickle cell disease implementation consortium (scdic)

Conditions: Anemia, Sickle Cell

Summary: the goal of this study is to specify the interventions, implementation strategies and control conditions from the sickle cell disease implementation consortium (scdic) using a mixed-methods approach to study site materials and conduct semi-structured qualitative interviews with site representatives (n=3 per site). we focused on the emergency department working group from the scdic working groups.

the long-term goal of this line of research is to identify the most effective components of scd interventions while also identifying effective implementation strategies informed by a systematic and rigorous work done by the members of the scdic consortium to improve the quality of life of people with scd, a life-threatening hematological disorder. this study aims to collect detailed information about the planned interventions, the implementation strategies and the control conditions from each site.

Eligibility criteria:
inclusion criteria: * three representatives of each of the sdic sites: the principal investigator, and two people nominated by the pi. exclusion criteria: * none
effect of ishige okamurae extract on musculoskeletal biomarkers in adults with relative sarcopenia

Conditions: Sarcopenia

Summary: the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of ishige okamurae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia for 12 weeks.

a previous study has indicated that ishige okamurae extracts may increase muscle mass and strength. therefore, the investigators conduct a randomized, double-blind, placebo-controlled study to investigate the effects of ishige okamurae extracts on muscle strength, muscle mass, and muscle function in adults with relative sarcopenia; the safety of the compound are also evaluated. the investigators examine the peak torque/body weight at 60°/s knee extension, handgrip strength, skeletal muscle mass, physical performance, and metabolic parameters at baseline, as well as after 6 and 12 weeks of intervention. eighty adults were administered either 300 mg of ishige okamurae extracts or a placebo each day for 12 weeks.

Eligibility criteria:
inclusion criteria: * \<110% of the standard lean body mass as measured using the body composition analyzer * body mass index (bmi) ranging from 18.5 to 30.0 kg/m2 * those who have an average protein intake of 60 g or more/day. exclusion criteria: * abnormal liver or renal function (more than twice the normal upper limit of the research institute) * uncontrolled diabetes mellitus (\>160 mg/dl of fasting blood sugar) * history of fracture during the previous year * uncontrolled hypertension (\>160/100 mmhg) * uncontrolled thyroid diseases. * history of serious cerebro-cardiovascular diseases or cancer such as angina or myocardial infarction within 6 months * history of any central bone fracture within 1 year * history of medication for psychiatric diseases such as severe depression, schizophrenia, drug intoxication. * alcohol abuser * allergic reaction to ishige okamurae * those who participated in other drug clinical trials within 1 month from the screening date. * severe gastrointestinal symptoms such as heartburn and indigestion * those who are pregnant, lactating, or plan to become pregnant during the clinical trial * those who are judged to be unsuitable by the pi for other reasons
mindfulness-based virtual reality intervention

Conditions: Hematologic Neoplasms

Summary: through virtual reality technology and mindfulness therapy, we can intervene the patients with hematologic neoplasms during chemotherapy, hoping to improve their symptoms and self-efficacy.

in recent years, the intervention method of giving mindfulness has achieved good results in the management of symptoms related to cancer patients, but the compliance of patients with conventional mindfulness intervention is low. the virtual reality intervention based on mindfulness can effectively mobilize the enthusiasm of patients to participate in research and the compliance of mindfulness training. we aim to combine virtual reality with mindfulness intervention to intervene patients with hematologic neoplasms during chemotherapy, to improve their symptoms.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of hematologic neoplasms(leukemia, lymphoma or multiple myeloma) and receiving chemotherapy * hospitalized for more than 4 weeks * have normal communication ability, clear consciousness, and willing to participate in this study exclusion criteria: * people are cognitive dysfunction and audio-visual dysfunction * have mental problems or have reported mental disorders
safety and immunogenicity study of glaxosmithkline (gsk) biologicals' 10-valent pneumococcal conjugate vaccine.

Conditions: Hepatitis A

Summary: three dose primary vaccination study of reactogenicity and immunogenicity in healthy infants between 6-12 weeks of age at the time of the first vaccination against streptococcus pneumoniae.

test groups: 2 (120 subjects/group). 1 group receiving gsk biologicals' 10-valent pneumococcal conjugate vaccine + dtpa combined vaccine; control group receiving gsk biologicals' havrix + dtpa combined vaccine

Eligibility criteria:
inclusion criteria: * male or female between, and including, 6 and 12 weeks (42-90 days) of age at the time of the first vaccination, free of obvious health problems and with written informed consent obtained from the parent/guardian of the subject. exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccine within 30 days preceding the first dose of study vaccine, or planned use during the study period. * planned administration/ administration of a vaccine not foreseen by the study protocol during the period starting from one month before the first dose of vaccine(s) and during the entire study period.