Kornimate/medical-research-clean huggingface dataset:
life-style interventions for modulating the brain phenotype of takotsubo cardiomyopathy

Conditions: Takotsubo Cardiomyopathy

Summary: takotsubo cardiomyopathy presents like a heart attack and is typically triggered by intense emotional or physical stress. recovery of this condition varies and many patients continue to suffer from symptoms such as fatigue and breathlessness for a protracted period after their event. the purpose of this study is to establish whether following a structured exercise program or a mental wellbeing program compared to usual care for 12 weeks after an episode of takotsubo will result in significant improvement in the brain activity, general and mental wellbeing of patients.

takotsubo cardiomyopathy is characterised by sudden onset left ventricular dysfunction precipitated by major stress. this neuro-cardiac condition has a 5-year morbidity and mortality comparable with acute myocardial infarction and no current therapies exist. the psycho-somatic basis of takotsubo suggests that its neuro-biology could be amenable to modulation. here, the investigators propose a mechanistic three-arm pilot feasibility trial of standardised physical exercise training, cognitive behavioural therapy and current standard of care in patients who suffered a very recent episode of takotsubo cardiomyopathy.

Eligibility criteria:
inclusion criteria: * patients diagnosed with takotsubo cardiomyopathy in the previous three weeks * participant who is willing and able to give informed consent for participation in the study. * participant who is willing to travel to aberdeen royal infirmary for the study visits. * healthy volunteers (for blood and saliva samples only) willing to give informed consent for participation in the study. healthy volunteers should not be on any medication. * for influenza t-cell testing: healthy volunteers who have recently received their annual flu vaccination. * myocardial infarction (mi) comparators: patients with type 1 acute mi (diagnosed within the last three weeks) exclusion criteria: * any patient whose takotsubo cardiomyopathy was triggered by a physical illness that would preclude them from taking part in a physical exercise training program * any patient who is not able or willing to travel to the cardiovascular research facility for their study visits * any patient who is not able to commit to a 12 week supervised training program * inability to exercise on a cycle ergometer or a treadmill (e.g. use of walking aids or prosthetic limbs or advanced frailty) * unwillingness to participate * contraindication to mri scanning such as implantable cardiac devices. * pregnancy * healthy volunteers taking medication

Keywords: takotsubo cardiomyopathy
improved prostate cancer diagnosis - combination of magnetic resonance imaging and biomarkers

Conditions: Prostate Cancer

Summary: prostate cancer has been the most common cancer in men in finland over the last ten years. prostate-specific antigen (psa) plays an important role in screening of prostate cancer. however, psa has a limited sensitivity and specificity for prostate cancer detection. commonly, the diagnosis of prostate cancer is done by transrectal ultrasonography (trus) guided biopsy. due to the low accuracy of trus, a systematic biopsy is usually performed instead of targeted trus biopsy. as biopsy carries a risk of increase in complications, there is an increasing interest in developing more accurate non-invasive imaging modalities. this study will enroll 150 men with clinical suspicion of prostate cancer due to higher serum level of psa than 2.5 ng/ml and/or abnormal digital rectal examination. multiparametric magnetic resonance imaging (mpmri) at 3 tesla (t) magnetic field using surface coils will be used to non-invasively predict the presence or absence of prostate cancer. targeted trus guided biopsy based on mri findings will be performed in addition to routine twelve core trus biopsy. moreover, selected serum and urine biomarkers as well as biomarkers extracted from fresh biopsy sample will be collected and correlated with the presence or absence of prostate cancer.


Eligibility criteria:
inclusion criteria: * age: 40 to 85 years * clinical suspicion of prostate cancer based on: serum level of psa from 2,5 ng/ml to 25 ng/ml in two following measurements and/or abnormal digital rectal examination * mental status: patients must be able to understand the meaning of the study * informed consent: the patient must sign the appropriate ethics committee (ec) approved informed consent documents in the presence of the designated staff exclusion criteria: * previous prostate biopsy in the last 6 months * previous diagnosis of prostate carcinoma * previous prostate surgeries, e.g. turp (transurethral prostatic resection) * symptomatic of acute prostatitis * contraindications for mri (cardiac pacemaker, intracranial clips etc) * uncontrolled serious infection * claustrophobia * any other conditions that might compromise patients safety, based on the clinical judgment of the responsible urologist
nutrition assessment in advanced cancer patients

Conditions: Advanced Cancer; Nutrition Aspect of Cancer; Prognostic Cancer Model

Summary: the goal of this retrospective observational study is to evaluate the prognostic value of nutrition assessment tool in advanced cancers. we aim to evaluate the clinical utility of nutrition assessment tool in predicting the clinical outcomes of cancer patients, which would help the clinicians to make tailored decision for this population.

to date, cancer is the leading cause of disability and death globally. cancer-related mortality rate differs significantly across the world, reflecting varying patterns of inherent genetic heterogeneity and medical resources available factors. considerable proportions of patients remained diagnosed with advanced-stage cancers at the initial visit, given the differences between demographic geographical and socioeconomic regions, and inadequate resources of china. for this reason, how to make adequate clinical management and prognostic prediction for advanced-stage cancers are still challenged. malnutrition is prevalent in cancer patients, accounting for approximately 20% to 80% of the cancer population, which plays a key role in the short-and long-term clinical outcomes. providing more real-world clinical evidence for supporting the beneficial role of nutritional screening in advanced-stage cancers can help to improve clinical nursing care for advanced-stage patients, especially in developing countries. the malnutrition status of cancer patients is often accompanied by symptoms of poor nutrient intake, weight loss, progress of systemic inflammatory disorders, and upregulated immune responses. emerging evidence has determined that the systemic pro-inflammation status was positively associated with elevated malnutritional scores and consistently predicted the worse survival probabilities of cancer patients. notably, the european society for clinical nutrition and metabolism (espen) expert consensus regarding the action against cancer-related malnutrition recommended that nutritionists were encouraged to use additional biomarkers to assess the severity of cancer-related systemic inflammation burdens, which might enhance the predictive value of existing malnutritional screening tools in clinical practice. although the pg-sga criteria, the nutrition assessment tool, has been widely interpreted and validated to be a simple and easily available tool for the prognosis prediction for varied cancers in recent years, the criteria of the pg-sga lacked the calculation of systemic inflammatory burdens. whether the inflammatory indicators could be the surrogate biomarkers for enhancing the prediction ability of pg-sga for advanced-stage cancer patients remains less studied. therefore, we aim to fill the mentioned research gaps to conduct this observational study.

Eligibility criteria:
inclusion criteria: * advanced cancers exclusion criteria: * aged below 18 * incomplete blood tests * incomplete follow-up data
evaluation of the aurora xi new nomogram software 2.0

Conditions: Apheresis Related Hypotension

Summary: a clinical trial to evaluate the safety and effectiveness of the aurora xi plasmapheresis system with a new plasma collection volume nomogram.

a controlled, prospective, randomized, multicenter, ide clinical trial to evaluate the safety and effectiveness of a new plasma collection volume nomogram on the aurora xi plasmapheresis system (test arm) as compared to the currently marketed optimized nomogram on the aurora xi plasmapheresis system (control arm). the new plasma collection volume nomogram will provide a more individualized approach to determining the volume of plasma collected from each donor. the trial will be conducted at a minimum of 3 plasma collection centers. subjects will be randomized into the test and control arms.

Eligibility criteria:
inclusion criteria: * all subjects must meet current safety guidelines for plasma donation as set forth by the fda as well as those in the standard operating procedures established by the participating institution. * enrolled subjects who do not meet inclusion criteria at a later donation attempt are eligible to remain in the clinical trial and to subsequently donate plasma once they meet eligibility criteria again. exclusion criteria: * subjects not able or unwilling to give consent to participate. * subjects withdrawn by a qualified healthcare provider due to safety concerns. * subjects who are employed by the clinical site or sponsor.
home air purification for eosinophilic copd

Conditions: COPD; Eosinophilia

Summary: this study evaluates the influence of home air purification on the lung health of adults with eosinophilic copd. half of the participants will receive real air purifiers (hepa filters) and half will receive sham air purifiers.

chronic obstructive pulmonary disease (copd) is the third most common cause of death in the united states, and is exacerbated by exposure to air pollution. knowledge about whether air purification affects the health of those with eosinophilic copd (approximately 40% of all copd patients seeking care), who generally have more active airway inflammation. if found to be beneficial, home air purification may offer a non-pharmacologic intervention for a large proportion of people with this common and serious disease. this study will evaluate whether home air purification affects lung function, respiratory symptoms, nasal biomarkers (inflammatory proteins and metals) among people with eosinophilic copd. participants will be randomized to receive real or sham air purifier in the bedroom and living room for 12 months. the intervention group will receive two high efficiency particulate air (hepa) air purifiers, while the control group will receive two sham air purifiers that look and sound the same as real hepa air purifiers.

Eligibility criteria:
inclusion criteria: * age of 40 years or more * physician diagnosis of copd \[global initiative for obstructive lung disease (gold) stage ii-iv disease with forced expiratory volume (fev1)/ forced vital capacity (fvc) ≤70% and fev1 (% predicted) \<80%\] * blood eosinophil count of \>=150 cells per μl at screening or in the previous year * former smoker with tobacco exposure of \>=10 pack-years exclusion criteria: * inability to complete monthly questionnaires * inability to perform lung function testing * regularly using a portable hepa air purifier in the home at time of enrollment * end stage chronic disease with life expectancy \<2 years as determined by pi judgment * living in location other than home (e.g. long term care facility) * planning to change residence within the study period
pet imaging of cancer patients using [18f]-ski-249380, a radiolabeled dasatinib-derivative

Conditions: Carcinoma; Sarcoma; Myeloma; Lymphoma; Melanoma

Summary: this study is the first time that a new experimental drug called \[18f\]-ski-249380 is being used in people. \[18f\]-ski-249380 is not a therapeutic drug. \[18f\]-ski-249380 is a drug that will be used with pet scanners to 'see' where \[18f\]-ski-249380 goes in the body, after its injected. the researchers believe that scans with \[18f\]-ski-249380 might be able to find tumors in patients. this study is being done to see how long \[18f\]-ski-249380 stays in the blood, when it is given to people in tiny amounts by an injection into a vein in their arm, and to see where \[18f\]-ski-249380 goes in the body. if the results of this trial are good, then the study doctors plan to use \[18f\]-ski-249380 in another trial to see if scans with \[18f\]-ski-249380 are better for finding tumors compared to the standard types of scans that doctors use.


Eligibility criteria:
inclusion criteria: * patients with history of histologically-confirmed neoplasm of any of the following classifications: solid malignancy, myeloid neoplasm, lymphoid neoplasm. * histology confirmed by mskcc department of pathology. * disease that is either: * radiologically-measurable or evaluable as defined by tumor response criteria from an mskcc-irb approved clinic research protocol. * detectable by biopsy (eg, bone marrow) and/or peripheral blood assays obtained within 6 weeks of study enrollment * age between 21-90 * negative serum pregnancy test for females of child-bearing age (11-55 years) and potential (ie, women who were not postmenopausal before the start of ongoing treatment, if applicable; and who have not had a surgical intervention whose intent or effect is sterilization, such as tubal ligation or hysterectomy.) * not breast-feeding, if applicable. exclusion criteria: * refusal or inability to discontinue medications or other substances (eg, foods or dietary supplements) that may affect \[18f\]-ski-249380 metabolism. notably, as dasatinib metabolism is cyp3a4-dependent, the metabolism of \[18f\]-ski-249380 may be altered by inhibitors and inducers of cytochrome p450 isoenzyme cyp3a4. the acceptability of medications and other substances used by the patient will be determined by the study investigators. * inability or refusal to have at least one peripheral intravenous line for intravenous access (as applicable to the day of \[18f\]-ski-249380 injection and blood draws.) * refusal or inability to tolerate the scanning procedure (e.g., due to claustrophobia) * hepatic: from assays obtained \<2 weeks prior to study enrollment * bilirubin \> 1.5 x institutional upper limit of normal (uln) * ast/alt \>2.5 x uln * albumin \< 2 g/dl * ggt \> 2.5 x uln if alkaline phosphatase \> 2.5 x uln. * renal: creatinine \>1.5 x uln or creatinine clearance \< 60 ml/min, from assays obtained \<2 weeks prior to study enrollment * acute major illness (e.g., unstable cardiovascular condition, etc.)

Keywords: [18f]-ski-249380 pet imaging ct imaging 12-182
8.4% sodium bicarbonate locks in intestinal failure

Conditions: Intestinal Failure; CRBSI - Catheter Related Bloodstream Infection

Summary: we plan to include children with intestinal failure, a condition where the gut is not functioning properly, leading these children to need central venous catheters (line that goes through the skin into the blood stream) for nutritional support and hydration. such patients have a very high risk for catheter infection. the study will include placing an agent (sodium bicarbonate) into the central catheter when the catheter is not in use. this is referred to as a lock. the lock would be used daily and removed when patients start their nutritional support and hydration through the catheter.

children with intestinal failure who rely on a silicone based central venous catheter for parenteral nutrition to provide nutritional support and hydration will be invited to participate in this study. the intervention will offer use of a specific catheter lock solution (8.4% sodium bicarbonate) when the catheter is not in use. this includes daily lock use with removal of the lock at end of dwell time.

Eligibility criteria:
inclusion criteria: * subject fulfills diagnosis of intestinal failure with a central venous catheter in place used daily on outpatient basis for intravenous nutrition and /or intravenous hydration * subject is less than 18 years of age at the time of study entry * subject with history of at least 1 documented catheter related blood stream infection (verified by blood culture)
safety and efficacy study of kai-1678 to treat subjects with postoperative pain

Conditions: Pain, Postoperative

Summary: the purpose of this study is to determine whether kai-1678 is effective in the treatment of postoperative pain following total hip or total knee replacement.


Eligibility criteria:
inclusion criteria: * american society of anesthesiologist (asa) classification 1, 2, or 3 * total hip or total knee replacement * pain on postoperative day 1 at least 40 mm on 0-100 mm visual analog scale (vas) exclusion criteria: * presence of contraindications to nonsteroidal anti-inflammatory (nsaid) treatment * recent history of angina or myocardial infarction (mi) * clinically significant abnormality on laboratory tests or electrocardiogram (ecg)

Keywords: ketorolac / therapeutic use analgesics. non-narcotic / therapeutic use arthroplasty, replacement hip arthroplasty, replacement knee pain measurement / drug effect pain postoperative / drug therapy
evaluation of oncoxin® in oral mucositis, appetite and body mass in cancer patients.

Conditions: Mucositis Oral

Summary: oral mucositis is one of the most spread side effects of anticancer therapy. it is associated with both chemo- and radiotherapy, decreases qol, relative dose intensity and leads to nutritive deficiency. oral mucositis causes secondary infections, increased hospital stay, whereas pain syndrome results in an emotional distress, anorexia and disables natural feeding.

primary: to evaluate the efficacy of oncoxin on oral mucositis symptoms in patients who receive chemotherapy and/or radiotherapy. secondary: to evaluate the effects of oncoxin on nutritional status in patients who receive chemotherapy and/or radiotherapy.

Eligibility criteria:
inclusion criteria: 1. a signed and dated informed consent form; 2. patients of both genders, aged 45-75; 3. malignant neoplasms which have radio-, chemotherapy or their combinations prescribed; 4. ecog ≤3; 5. who oral toxicity scale grade 2 - 3. exclusion criteria: 1. significant, according to the investigator judgement, concomitant diseases or states which make it complicate or even impossible the patient's participation in the study or make it difficult to interpret the clinical data obtained in any stage of the study always including the following: * mental disorders; * serious/chronic infectious and parasitic diseases; * intolerability to any of oncoxin components. 2. relations with study center personnel (study center staff or family member of the investigator, coordinator or assistant). 3. if the patient fails to assess his/her physical and emotional condition; 4. if the patient fails to comply with the requirements; 5. patient's refusal to participate in the study; 6. pregnancy or lactation.

Keywords: oral mucositis nutritional supplement chemotherapy radiotherapy ocoxin / oncoxin
human milk in preterm infants

Conditions: Preterm Birth

Summary: current nicu protocol introduces human milk fortifier at 8 days of feeding. this study will introduce human milk fortifier at day 1. the primary outcome is the effect on growth velocity at 28 days and 36 weeks post menstrual age.


Eligibility criteria:
inclusion criteria: * birth weight 1000-1500 grams * admitted to nicu within 24 hours of life * maternal intent to use human milk exclusion criteria: * congenital anomalies * feeds not started within the first 96 hours of life * intrauterine growth restriction
comparison for efficacy and safety of bowel preparation between oral sulfate table and 2l-polyethylene glycol/ascorbate in elderly

Conditions: Colonic Disease; Intestinal Disease

Summary: this study compares the effectiveness and stability of intestinal tablet (ost), an oral sulfate table (ost), developed in the form of pills, with 2l-peg/asc for examinees aged 70 or older who are scheduled for colonoscopy.

this study is comparison for efficacy and safety of bowel preparation between oral sulfate table and 2l-polyethylene glycol/ascorbate in elderly: multicenter, prospective, investigator single-blinded, randomized study. a total of 256 subjects will participate to this study and be assigned to the test group or the control group. the subject will administer the first dose of assigned investigational product in the evening prior to the scheduled colonoscopy. subject will take the second dose early in the morning of the colonoscopy.

Eligibility criteria:
inclusion criteria: * age over 70 * patients who is scheduled a colonoscopy * patients who is informed and give a consent in voluntary exclusion criteria: * history of colectomy * patients over american society of anesthesiology class iii * patients who has difficulty swallowing * in the case of abnormal findings requiring treatment in the basic blood test * patients with uncontrollable chronic diseases * patients suspected of having paralytic ileus or intestinal obstruction. * patients who complains of alarm sign (severe abdominal pain, weight loss, anemia, gastrointestinal bleeding, etc.) * patients who has a history of drug abuse and addiction * patients who for any reason, are deemed by the investigator to be inappropriate for this study

Keywords: colonoscopy orafang bowel cleaning
convalescent plasma vs. standard plasma for covid-19

Conditions: COVID

Summary: the purpose of this study is to find out if transfusion of blood plasma containing antibodies against covid-19 (anti-sars-cov-2), which were donated from a patient who recovered from covid-19 infection, is safe and can treat covid-19 in hospitalized patients. antibodies are blood proteins produced by the body in response to a virus and can remain in the person's bloodstream (plasma) for a long time after they recover. transferring plasma from a person who recovered from covid-19 may help neutralize the virus in sick patients' blood, and/or reduce the chances of the infection getting worse.


Eligibility criteria:
there are 2 groups of research subjects: plasma donor and recipients volunteer plasma donors can donate convalescent plasma if they: * have adequate antibody levels against covid-19 per fda guidelines * have had no symptoms of covid-19 for at least 14 days * meet routine plasma donation criteria inclusion criteria for plasma recipients: * adults 18 years of age or older * hospitalized with pcr+ covid-19 infection * if female must not be pregnant and/or breastfeeding. exclusion criteria for plasma recipients: * unable to randomize patient within 14 days of admission to stony brook hospital (or any other hospital if a transfer to stony brook hospital). * in the treating physician's opinion, the patient cannot tolerate a 450-550 ml infusion of plasma over up to 8 hours (4 hours max per unit), even if prophylaxed with intravenous diuretic * contraindication to transfusion or history of prior reactions to blood transfusions