Kornimate/medical-research-clean huggingface dataset:
effect of music intervention on anxiety in cancer patients undergoing initial radiation therapy

Conditions: Cancer Patients; Anxiety; Music Intervention; Radiation Therapy

Summary: this prospective randomized trial evaluated the effect of music interventions on anxiety and nervousness during 10 consecutive days in individuals undergoing their first radiation therapy session.

a total of 100 participants were enrolled and randomly assigned to either the music group or nonmusic group (n = 50 each). investigators ensured an equal distribution of men and women, without considering the cancer type. to minimize confounding factors and prevent shared learning experiences or communication between the two groups, the participants in the experimental and control groups were scheduled for treatment at different times throughout the year (from january 1, 2022 to december 31, 2022). anxiety assessment questionnaires were administered before the treatment began and after 2 weeks of treatment. physiological parameters, including heart rate, systolic and diastolic blood pressure, and blood oxygen levels, were monitored before and after 2 weeks of treatment. in the music intervention group, the patients received music intervention during rt for 10 consecutive days and listened to music for approximately 10-15 minutes in each session. the music period was then followed by a 10-day period without music during treatment to evaluate the differences in the same individuals. in contrast, the control group did not receive music intervention throughout their entire rt period. investigators observed the music intervention group for 2 weeks to ascertain any differences.

Eligibility criteria:
inclusion criteria: * patients undergoing rt for cancer for the first time * patients with clear consciousness and normal hearing * patients willing to respond to the questionnaire after the research process and purpose were explained to them. exclusion criteria: * patients who had previously undergone rt * patients with diminished mental capacity or inability to satisfactorily participate in this study * patients with moderate to severe hearing impairment.
high-intensity interval vs. moderate continuous training in surgical prehabilitation.

Conditions: Colorectal Cancer; Physical Activity

Summary: surgery is a stressful procedure associate with perioperative physical impairment. in a previous study, the investigators showed that physical fitness could be optimize in surgical patients using prehabilitation, a preoperative conditioning intervention in form of exercise, nutrition and relaxation technique. the best modality of exercise has yet to be known.the purpose of this study is to compare high interval (hit) vs. moderate continuous intensity (mc) training, integrated in a prehabilitation intervention in colorectal surgical patients.

all patients will receive prehabilitation preoperatively for 4 weeks, that is composed of 3 elements, exercise, nutritional supplements and psychological coping strategies. both exercise protocol will be supervised, 3-time per week, in-hospital programs. patients will be randomized to perform either hit or mc training. exercise intensity will be defined and personalized on the individual values at cardiopulmonary exercise testing (cpet). patients' nutritional status and dietary intake will be assessed by the nutritionist, and supplement will be prescribed if needed to achieve a daily intake of 1.5 g protein/kg. perioperative care will follow the mcgill surgical recovery pathway, also called enhanced recovery program, which is an evidence-based care plan set up by the surgical recovery (sure) multidisciplinary committee of the mcgill university health centre.

Eligibility criteria:
inclusion criteria: * subjects eligible to enter the study will include those aged 18 and above and referred electively for resection of malignant colorectal lesions. exclusion criteria: * american society of anesthesiologists (asa) health status class 4-5 or co-morbid medical, physical and mental conditions interfering with the ability to perform exercise at home or to complete the testing procedures. poor english and french comprehension.

Keywords: prehabilitation
a study to evaluate the efficacy, drug levels and safety of luspatercept (ace-536) for the treatment of anemia due to ipss-r very low, low, or intermediate risk myelodysplastic syndromes in chinese and japanese participants with ring sideroblasts who require red blood cell transfusions

Conditions: Myelodysplastic Syndromes

Summary: the purpose of this study is to evaluate the efficacy and safety of luspatercept (ace-536) for the treatment of anemia due to revised international prognostic scoring system (ipss-r) very low, low, or intermediate risk myelodysplastic syndromes (mds) in chinese and japanese participants with ring sideroblasts who require red blood cells (rbc) transfusions.


Eligibility criteria:
inclusion criteria: * refractory or intolerant to, or ineligible for, prior erythropoiesis stimulating agent (esa) treatment as defined by any one of the following: refractory to prior esa treatment, intolerant to prior esa treatment, or esa ineligible. * previously treated with an esa or granulocyte colony-stimulating factor, granulocyte-macrophage colony-stimulating factor, both agents must have been discontinued ≥ 4 weeks prior to date of luspatercept treatment * eastern cooperative oncology group (ecog) score of 0, 1, or 2 exclusion criteria: * prior therapy with disease modifying agents for underlying mds disease * known clinically significant anemia due to iron, vitamin b12, or folate deficiencies, or autoimmune or hereditary hemolytic anemia, or gastrointestinal bleeding * serum aspartate aminotransferase/serum glutamic oxaloacetic transaminase (ast/sgot) or alanine aminotransferase/serum glutamic pyruvic transaminase (alt/sgpt) ≥ 3.0 x upper limit of normal (uln) other protocol-defined inclusion/exclusion criteria apply

Keywords: myelodysplastic syndromes mds ace-536 anemia luspatercept
bone biopsy study for dialysis patients with secondary hyperparathyroidism of end stage renal disease

Conditions: Secondary Hyperparathyroidism

Summary: the purpose of this study is to evaluate the effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

secondary hyperparathyroidism (hpt) is common in people with end stage renal disease (kidney disease). patients with secondary hpt often have enlarged parathyroid glands in the neck and as a result often have elevated parathyroid hormone (pth) levels . patients with secondary hpt may have bone disease (osteodystrophy). cinacalcet has been used to decrease pth levels in patients with secondary hpt. patients with secondary hpt may have bone disease (osteodystrophy). this bone disease may cause bone pain, fractures, and poor formation of red blood cells. the purpose of this study is to evaluate effects of cinacalcet on markers of bone turnover in patients with kidney disease who are receiving dialysis.

Eligibility criteria:
inclusion criteria: subjects will be eligible for the study if they meet all of the following criteria: * one intact parathyroid hormone (ipth) determination obtained from the central laboratory must be \>/= 300 pg/ml. * one serum calcium determination obtained from the central laboratory must be \>/= 8.4 mg/dl (2.1 mmol/l). * one bone alkaline phosphatase (balp) determination obtained from the central laboratory must be \>/= 20.9 ng/ml. * positive histologic confirmation of high bone turnover disease as assessed by the central bone histology center. * treated with dialysis \>/= 1 month before the date of informed consent. exclusion criteria: subjects will be ineligible for the study if they: * have an unstable medical condition in the judgment of the investigator. * are pregnant or nursing women. * had a parathyroidectomy in the 3 months before the date of informed consent. * for subjects prescribed vitamin d, have received vitamin d therapy for less than 30 days before day 1 or required a change in vitamin d brand or dose level within 30 days before day 1. * ever received therapy with sensipar®/mimpara®

Keywords: cinacalcet hcl, cinacalcet, amgen (amg) 073, sensipar, mimpara, calcimimetic
intravenous (iv) saline and exercise in postural tachycardia syndrome (pots)

Conditions: Postural Tachycardia Syndrome

Summary: the investigators will test whether an intravenous infusion of saline (salt water) will improve the exercise capacity in patients with postural tachycardia syndrome (pots).


Eligibility criteria:
inclusion criteria: * meet diagnostic criteria of postural tachycardia syndrome (pots) 28 * age between 18-65 years * male and female are eligible (although the majority of pots patients are female). * able and willing to provide informed consent exclusion criteria: * presence of medical conditions that can explain postural tachycardia (e.g., acute dehydration, medications) * pregnancy * other factors which in the investigator's opinion would prevent the subject from completing the protocol. * patients who are bedridden or chair-ridden

Keywords: orthostatic intolerance exercise capacity tachycardia pots
multilayer biological characterization of advanced follicular lymphoma: a translational study from fil_foll12 trial

Conditions: Follicular Lymphoma

Summary: this is a multicenter, retrospective, biological study ancillary to foll12 trial to evaluate the role of ezh2 aberrations in patient with fl treated with immunochemotherapy. moreover, several novel biomarkers of fl will be investigated.

current standard first-line treatment for advanced follicular lymphoma (fl) is still represented by chemoimmunotherapy combinations, with chop/cvp or bendamustine (b) as the main regimens with no standard criteria to prefer one over another. ezh2 mutations have been associated with longer progression-free survival (pfs) in patients treated with chop/cvp regimens, but not with bendamustine (independently from the type of anti-cd20 therapy received). the fil_foll12 trial (nct02063685), a large phase iii trial (with a pre-planned biological material sampling) enrolling 807 advanced fl patients treated with front-line r-chop or bendamustine-rituximab (br), appears an ideal platform to validate the predictive value of ezh2 and its applicability to the clinical practice. the aim of this study is to provide to clinicians a useful and practical biomarker to guide the choice of the most effective chemotherapy backbone (in addition to anti-cd20 immunotherapy) for first line treatment of patients with advanced fl (e.g. r-chop for ezh2 aberrated vs br for ezh2 wild type patients). moreover, to implement an italian network of laboratories able to provide these translational outputs within a rapid turnaround time. finally, taking advantage of the already collected bm and pb samples, several novel biomarkers of fl heterogeneity will be investigated, in particular: ezh2 protein expression in tumor samples, alternative molecular markers for minimal residual disease (mrd), clonal hematopoiesis of indeterminate potential (chip), pharmacogenomics and constitutional genomics as well as microbiome profiles.

Eligibility criteria:
inclusion criteria: * patient enrolled in the fil_foll12 trial (documented by the signature of the study informed consent); * availability of biological samples: bone marrow aspirate, peripheral blood and/or ffpe diagnostic sample (nodal or extranodal); exclusion criteria: * none

Keywords: lymphoma follicular immunochemotherapy fl aberration mutation ezh2 chop bendamustine biological rituximab biomarker
stem cell therapy for type 2 diabetes mellitus

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of the study is to evaluate the efficacy and safety in the treatment of insulin resistance of type 2 diabetes mellitus with bone marrow mesenchymal stem cells.

* to evaluate the feasibility and safety of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus undergoing insulin injection treatments. * to assess efficacy of transplantation treatment using umbilical cord mesenchymal stem cells in patients with type 2 diabetes mellitus.

Eligibility criteria:
inclusion criteria: 1. free will taking part in the study and ability to provide written informed consent; 2. type 2 diabetes mellitus (as guideline who, 1999); 3. age 18-75 years old，male/female; 4. 19≤body mass index (bmi)≤30㎏/㎡; 5. fast blood glucose (fbg)≥7.0 mmol/l, and hbac1≥7％; 6. intravenous insulin tolerance test（itt）indicate patient being insulin resistance; 7. not pregnant or nursing; 8. negative pregnancy test; 9. fertile patients will use effective contraception. exclusion criteria: 1. severe concurrent medical condition (e.g., serious heart disease, lung disease, or hematopoietic dysfunction, or liver dysfunction, or kidney dysfunction); 2. active infection requiring treatment; 3. unexplained febrile illness; 4. known immunosuppressive disease, e.g. hiv infection, or hepatitis b or c infection.

Keywords: stem cells; diabetes mellitus; treatment.
additional glucose lowering and anti-inflammatory effects by acarbose and alcohol in subjects with impaired glucose tolerance or mild type 2 diabetes

Conditions: Diabetes Mellitus; Impaired Glucose Tolerance

Summary: to understand if acarbose, an alpha-glucosidase inhibitor usually for treating diabetes, will further lower post meal glucose and inflammatory state when taking together with moderate amount of alcohol during meal tolerance test in subjects with impaired glucose tolerance or mild diabetes.


Eligibility criteria:
inclusion criteria: * subjects with mild diabetes without prior medications or impaired glucose tolerance exclusion criteria: * pregnancy * recent major cardiac, renal and hepatic disease * intolerance to alcohol * allergy to acarbose treatment

Keywords: diabetes acarbose alcohol inflammation oxidative stress mild diabetes mellitus
multicenter open-label randomized controlled trial (rct) to compare colistin alone versus colistin plus meropenem

Conditions: Gram-Negative Bacterial Infections

Summary: the purpose of this study is to determine whether the addition of meropenem to colistin is better than colistin alone in the treatment of clinically significant infections caused by multi-drug resistant bacteria


Eligibility criteria:
inclusion criteria: * adult inpatients * clinically significant, microbiological-documented infection caused by carbapenem-resistant and colistin-susceptible gram-negative bacteria and identified according to cdc criteria- blood stream infections, hospital acquired pneumonia, ventilator associated pneumonia, and urinary tract infections * patient recruitment will occur only after microbiological documentation and susceptibility testing. patients will be included within 96 hours of the time the index culture was taken (typically within 48 hours of isolate identification), regardless of the antibiotic treatment administered during this time period. exclusion criteria: * previous inclusion in the trial. patients will be included in the rct only once for the first identified episode of infection * pregnant women * epilepsy or prior seizures * known allergy to colistin or a carbapenem

Keywords: gram-negative bacterial infections resistant bacteria drug resistance, bacterial colistin
endoscopic ultrasound predict the sensitivity of stage ii / iii rectal cancer preoperative concurrent chemoradiotherapy

Conditions: Rectal Cancer

Summary: the purpose of this study is to determine the role of endoscopic ultrasound measurement of the primary tumor maximum diameter changes in absolute / relative values in predicting the tumor regression after concurrent chemoradiotherapy for rectal cancer.

we use endoscopic ultrasound to measure the primary tumor maximum diameter changes to predict the tumor regression after concurrent chemoradiotherapy for rectal cancer

Eligibility criteria:
inclusion criteria: * pathologically confirmed rectal cancer, preoperative stage ii / iii (t3-4n0 or t1-4n + m0). * tumor distance from anus less than 12 cm. * kps score not less than 70 * can be tolerated chemotherapy and radiotherapy. * pelvic who had no history of radiation therapy. * non-allergic history of fluorouracil or platinum-based chemotherapy drugs. * a full understanding of the study, the ability to complete all of the treatment plan, follow up the conditions and sign the informed consent. exclusion criteria: * other malignancy (past or at the same time), does not include curable non-melanoma skin cancer and cervical carcinoma in situ; does not include resectable primary colon cancer (synchronous or metachronous). * pregnant or lactating patients. * fertility but did not use contraceptive measures. * existing active infection. * merge serious complications, can not tolerate the treatment, such as 6 months of myocardial infarction, mental illness, uncontrollable diabetes or uncontrollable hypertension or hypotension. * concurrent treatment with other anticancer drugs. * can not complete treatment or follow-up.

Keywords: endoscopic ultrasound pre-operative concurrent chemoradiotherapy
angiotensin ii for septic shock treatment

Conditions: Septic Shock

Summary: this study aims to investigate the effect of angiotensin ii on microcirculation and peripheral perfusion in patients with septic shock.

shock is a syndrome characterized by acute circulatory failure resulting in impaired peripheral tissue perfusion. distributive shock is the most common type of shock and is usually caused by severe sepsis. distributive shock is characterized by profound vasodilatation leading to decreased arterial blood pressure and impaired organ perfusion despite high cardiac output. the use of vasopressors is an essential management line for distributive sock. two groups of vasopressors are usually used for management of shock: catecholamines and vasopressin-like peptides. there is a continuous need for other vasopressors because: 1- available vasopressors have narrow therapeutic window. 2- patients with severe hypotension refractory to the currently available classes usually die. a third system is usually engaged in the physiology of shock which is renin-angiotensin-aldosterone system. angiotensin ii is a natural hormone which is a potent vasopressor; moreover, angiotensin ii stimulates the production of both antidiuretic hormone and adrenocorticotropin hormone. in a pilot study, angiotensin ii was reported as an effective rescue vasopressor in septic shock patients on multiple vasopressors. angiotensin ii improved mean arterial pressure and helped in reduction of the doses of catecholamines. in a recent large randomized controlled trial, angiotensin ii improved blood pressure in catecholamine-resistant distributive shock patients. microcirculation is the primary site of oxygen and nutrient exchange. maintenance of microcirculatory perfusion is a prerequisite for preservation of organ function. multiple organ failure is common in patients with distributive shock despite maintenance of parameters of global perfusion due to disrupted microcirculatory perfusion. furthermore, restoration of microcirculatory perfusion was correlated with improvement in survival. this study aims to investigate the effect of angiotensin ii on peripheral microcirculation in patients with septic shock.

Eligibility criteria:
inclusion criteria: * septic shock patients. * aged above 18 years. * with cardiac index \> 2.4 l/min/bsa 1.73 m2. * on high dose vasopressors (defined as norepinephrine infusion above 0.1 mcg/kg/min) exclusion criteria: * acute coronary syndrome. * impaired cardiac contractility * bronchospasm. * major burns * liver failure. * active bleeding.
swallowing impairment after covid-19 infection

Conditions: Covid19

Summary: this is an observational study, in which people recovering from covid-19 infection will attend an outpatient clinic for a comprehensive swallowing assessment. the assessment will include a videofluoroscopy, measurement of respiratory-swallow coordination using a digital stethoscope, measures of tongue and cough strength and patient reported measures that will help us to understand the presence and impact of swallowing impairment (dysphagia) in this population.

the recent spread of covid-19 has led to an international pandemic, with \>3 million confirmed cases to date worldwide, of which 1 million confirmed cases and \>50,000 deaths have been reported in the usa. infected individuals commonly experience severe respiratory difficulties and pneumonia, leading to hospital admission and the need for intensive care and mechanical ventilation. emerging evidence suggests that impaired taste and smell may be early markers of the disease, and that in severe cases, there may be neurological damage in in the medulla, an important brainstem control site for both respiration and swallowing. given the overlapping neuroanatomical regulation of breathing and swallowing, the investigators hypothesize that dysphagia (swallowing impairment) will be common in people recovering from covid-19 (prc-19) and associated with poorer outcomes. the investigators will offer comprehensive swallowing assessments to prc-19 after initial recovery and a confirmed negative test for continuing covid-19 infection. study sites will be located in the toronto area (pi steele); the hamilton-niagara region to the west of toronto (co-i namasivayam-macdonald) and in gainesville, florida (co-i plowman). the assessments will include the collection of case history information, videofluoroscopy (i.e., a dynamic swallowing x-ray), use of a digital stethoscope to measure respiratory-swallow coordination, measures of other risk factors for dysphagia (e.g. bulbar muscle strength) and patient-reported outcomes. detailed analyses of the videofluoroscopy swallowing studies (i.e. dynamic x-rays) will identify specific measures of swallowing that fall outside the range of normal variation based on comparison to healthy reference values established through the pi's nih-funded research program exploring swallowing physiology on liquids of different consistencies.

Eligibility criteria:
inclusion criteria: * people who tested positive or received a presumed positive diagnosis of covid-19 infection not earlier than march 1, 2020 and who are at least 2 weeks post positive diagnosis and the initiation of medical management of covid-19 infection * adequate comprehension of english to understand the consent form and follow study instructions exclusion criteria: * age under 18 years old * current pregnancy

Keywords: swallowing
genetic and immunologic basis of covid-19 infection

Conditions: Genetic Basis of COVID-19 Infection

Summary: we will study genetic factors causing severe disease due to infection with sars-cov-2 which may help to find targeted therapy


Eligibility criteria:
inclusion criteria: * severe covid-19 infection exclusion criteria: * comorbidity ((dm, hypertension, chronic liver or kidney diseases, hiv, morbid obesity, malignancy, immunosuppressive therapy)

Keywords: sars-cov-2, genetics