Kornimate/medical-research-clean huggingface dataset:
monitoring effect of shock wave on microcirculation changes in type2 diabetes mellitus

Conditions: Shock Wave and Nitric Oxide

Summary: the purpose of the study is to monitor the effect of low intensity extracorporeal shock wave therapy on impaired nitric oxide synthase and microcirculation changes in type 2 diabetes mellitus with peripheral neuropathy.

low-intensity extracorporeal shockwave therapy (li-eswt) improved peripheral nerve repair and regeneration. li-eswt exerts its biological effects by increasing neuro¬trophic factors, schwann cell activation, and cellular signaling activation. li-eswt could be a novel treatment for nerve injury-induced diabetic neuropathy and other conditions related to nerve in¬jury.

Eligibility criteria:
inclusion criteria: * patients have to be symptomatically stable with type 2 diabetes mellitus complicated with peripheral neuropathy. * optimized pharmacological treatment that will be remained unchanged throughout the study. exclusion criteria: * implanted cardiac pacemakers. * patients with known skin allergies. * presence of skin inflammations. * peripheral vascular disease. * patients with unstable angina pectoris. * progressive ventricular dysrhythmia. * intermittent claudication.

Keywords: shock wave ntric oxide diabetes mellitus nerve conduction velocity
antioxidant supplementation in trauma patients

Conditions: Multiple Trauma

Summary: administration of antioxidants to trauma patients will improve measures of oxidant stress in the blood


Eligibility criteria:
inclusion criteria: * adult non pregnant non lactating trauma patient exclusion criteria: * gcs \<6 * renal dysfunction (cre \> 2.5 mg/dl) * hepatic dysfunction ( tbili \> 3.0 mg/dl) * expected survival \< 48 hours * burns over \> 20% body surface area * immune-deficiency syndromes * steroid use

Keywords: antioxidant oxidant stress trauma free radical
efficacy of aliskiren compared to ramipril in the treatment of moderate systolic hypertensive patients

Conditions: Essential Hypertension

Summary: this prospective multicenter, double blind study will evaluate the efficacy and safety of aliskiren versus ramipril in patients with moderate systolic essential hypertension.


Eligibility criteria:
inclusion criteria: * outpatients \> 18 years * male or female patients. female patients must have been either post-menopausal for one year, surgically sterile, or using effective contraceptive methods * patients with essential hypertension, previously treated with an antihypertensive single-drug therapy, either uncontrolled or intolerant. * bp thresholds at visit 1: * for patients previously treated and uncontrolled: 140≤ office sbp\<180 mmhg * for patients previously treated, controlled but intolerant: office sbp≥130 mmhg * bp thresholds at visit 2 (for all patients): * 160≤office sbp\<180 mmhg and * 155≤home sbp\<175 mmhg (3-day period of home blood pressure monitoring just before randomization) exclusion criteria: * women of child-bearing potential not using any effective methods of contraception * severe hypertension (office bp ≥ 180/110 mmhg) * impossibility to stop abruptly previous antihypertensive treatments at visit 1 * patients previously untreated or patients treated with two or three antihypertensive medications * history or evidence of a secondary form of hypertension * history of hypersensitivity to acei or renin inhibitors * history of heart failure, stroke or coronary heart disease * serum potassium ≥ 5.2 mmol/l other protocol-defined inclusion/exclusion criteria may apply

Keywords: moderate systolic hypertension - adults - aliskiren -ramipril
role of active deresuscitation after resuscitation-2

Conditions: Critical Illness; Sepsis; Trauma

Summary: radar-2 will be a randomised, open-label, allocation concealed, pilot trial of conservative fluid administration and deresuscitation compared with usual care in patients who are critically ill.

the optimal approach to fluid balance in critically ill patients is uncertain. a recent systematic review found low quality evidence in favour of a conservative fluid or deresuscitative approach (active removal of accumulated fluid using diuretics and/or renal replacement therapy) compared with a liberal strategy or usual care. the radar-2 pilot randomised trial will compare conservative fluid and deresuscitation with usual care in patients who are mechanically ventilated in an intensive care unit. the main hypothesis is that in critically ill patients, a post-resuscitation fluid strategy comprising conservative fluid administration and active deresuscitation reduces net fluid balance, is safe and improves clinical outcomes.

Eligibility criteria:
inclusion criteria: 1. invasive mechanical ventilation 2. treating icu doctor expects patient to require treatment in an icu beyond the next calendar day 3. between 24 and 48 hours from icu admission at the time of randomisation exclusion criteria: 1. age \< 16 years 2. body weight \<40kg (measured or estimated) 3. diabetic ketoacidosis or hyperosmolar hyperglycaemic state 4. non-traumatic subarachnoid haemorrhage 5. acute cardiac failure or cardiogenic shock 6. end-stage renal failure (on dialysis) 7. known to be pregnant 8. suspected or proven active diabetes insipidus (ddavp within 24 hours) 9. not expected to survive for 72 hours 10. active 'do not attempt resuscitation' order 11. refusal of consent 12. inability of personal consultee to understand written or verbal information and for whom no interpreter is available 13. known allergy to one or more of the study drugs 14. inability to measure fluid balance

Keywords: fluid therapy furosemide diuretics injections, intravenous infusions, intravenous spironolactone indapamide
diuretic testing in chronic kidney disease

Conditions: Kidney Disease, Chronic

Summary: the goal of this clinical trial is to predict the progression of chronic kidney disease by diuretic testing in patients with chronic kidney disease. the main questions it aims to answer are: does a worse result of a diuretic test predict the progression of chronic kidney disease? if there is a comparison group: researchers will compare the diuretic test in patients with chronic kidney disease to healthy participants to see if the results are different in a healthy kidney. participants will undergo diuretic testing. this involves the administration of bumetanide and hydrochlorothiazide with subsequent blood and urine collections.


Eligibility criteria:
inclusion criteria for ckd subjects: * ckd stage g3 (creatinine-based egfr 30-59 ml/min/1.73m2) during the last outpatient visit inclusion criteria for healthy subjects: • egfr within the expected range for age (a decline of 1 ml/min/1.73 m2 per year starting from age 40 is considered the normal age-related decline in kidney function exclusion criteria: * known intolerance or allergy to the diuretics * current systemic chemotherapy for malignancy * kidney transplant recipient * use of calcineurin-inhibitors * life expectancy \< 12 months * current immunosuppressive treatment for glomerulonephritis * incapacitated subjects or subjects who are deemed unfit to adequately adhere to instructions from the research team * hypokalemia or hyperkalemia (k+ \ 5.5 mmol/l) at inclusion visit * hypo- or hypernatremia (na+ \ 150mmol/l) at inclusion visit * inherited tubulopathy as the cause of ckd * autosomal dominant polycystic or tubulointerstitial kidney disease causing ckd * clinically relevant heart failure (new york heart association class iii or iv) * therapy-resistant hypertension, defined as systolic blood pressure \> 180mmhg at the inclusion visit * current treatment with inhibitors of organic anion transporters: probenecid, pravastatin, cimetidine, cephalosporins, acetazolamide \[22\] * active hepatitis during last outpatient visit * liver cirrhosis in advanced stage (child-pugh b or c) * active drug- or alcohol abuse * not being able to tolerate a 28-day washout of one of the drugs interfering with diuretic testing. * women who are pregnant, breastfeeding, or planning on becoming pregnant before the test day

Keywords: disease progression diuretic testing chronic kidney disease kidney tubular function
digital cognitive behavioral therapy for insomnia for chronic insomnia in breast cancer survivors

Conditions: Chronic Insomnia

Summary: to explore the efficacy of dcbt-i therapy for chronic insomnia among breast cancer survivors in china, we propose to conduct a randomized, parallel controlled clinical study in breast cancer survivors using a smartphone chinese application (app) "resleep". breast cancer survivors with chronic insomnia were recruited from our breast disease center and externally, with the waiting group as a parallel control and the dcbt-i treatment group as an intervention group, in a 1:1 sample size. intervention group (dcbt-i treatment group) will receive full self-help dcbt-i administered by smartphone app for 6 weeks. the control group (waiting for treatment group) will not receive any additional interventions based on the original conventional treatment and will be followed up as planned, waiting for treatment.at the end of the 3-month follow-up, the decision to receive treatment was made according to the patient's wishes. the primary endpoint was the insomnia severity index (isi) at the end of treatment and at 3 months of treatment.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. breast cancer diagnosed within 5 years 3. stable disease at the end of acute treatment (surgery, radiotherapy, chemotherapy) while meeting: ≥ 1 month after surgery, ≥ 3 months after the end of last chemotherapy, and ≥ 3 months after the end of last radiotherapy if radiotherapy is required. 4. satisfy the diagnostic criteria for chronic insomnia disorder according to the (international classification of sleep disorders-the third edition, icsd-3)\[ and diagnostic and statistical manual of mental disorders, fifth edition (dsm-5): problem with falling asleep or maintaining sleep for ≥3 months (≥3 times per week) with impaired daytime functioning, despite the availability of sleep opportunities. 5. isi score ≥12. 6. other sleep or psychiatric disorders, if present, must be stable and require no medication. 7. be proficient in the use of a cell phone application, and be comfortable reading, filling out the electronic questionnaire, communicating, and fully understanding the content. 8. sign the informed consent form. - exclusion criteria: 1. new breast cancer progression, recurrence, or metastasis within 3 months, requiring new radiotherapy or immunotherapy regimen 2. expected survival \<12 months due to all causes 3. presence of any of the following conditions: concurrent active cancer or malignancy that is being treated other than breast cancer, shift work, alcohol abuse, substance abuse, significant suicidal ideation, bipolar disorder, aggressive behavior, mania, schizophrenia. 4. presence of a diagnosed significant physical illness that interferes with sleep, such as cranial disease or trauma, cancer pain, unstable angina, uncontrolled cardiac insufficiency and severe respiratory distress due to various causes, etc. 5. current or previous treatment with cognitive behavior therapy for insomnia (cbt-i). 6. not signed informed consent.

Keywords: insomnia cognitive behaviour therapy for insomnia breast cancer
pediatric cardiomyopathy mutation analysis

Conditions: Cardiomyopathies; Dilated Cardiomyopathy; Hypertrophic Cardiomyopathy; Restrictive Cardiomyopathy; Arrhythmogenic Right Ventricular Cardiomyopathy; Left Ventricular Non-compaction Cardiomyopathy

Summary: the goal of this protocol is to obtain information from individuals with cardiomyopathy and from their families in order to elucidate the molecular genetics of this disorder. this will provide the basis for future genetic counseling as well as contribute to elucidating the biology of normal and abnormal cardiac function.

cardiomyopathy is a genetically heterogeneous heart muscle disorder that results in ventricular dysfunction. while significant progress has been made in identifying the genetic basis of cardiomyopathy in adults, molecular diagnosis in children has proven more challenging and current algorithms do not incorporate mutation analysis in the clinical protocol. however, recent studies indicate that cardiomyopathy outcomes in children are origin specific, highlighting the importance of precise diagnosis. the goal of this study is to identify the genetic causes of pediatric cardiomyopathy. rapid, comprehensive and cost-effective detection of genetic causes of cardiomyopathy will aid management and development of novel treatment strategies.

Eligibility criteria:
inclusion criteria: * subjects with cardiomyopathy * family members of subjects with cardiomyopathy exclusion criteria: * subjects without cardiomyopathy * family members of subjects without cardiomyopathy

Keywords: cardiomegaly cardiovascular diseases heart diseases systolic dysfunction diastolic dysfunction ventricular hypertrophy heart failure
study of acalabrutinib versus chlorambucil plus rituximab in adult subjects with previously untreated chronic lymphocytic leukemia

Conditions: Untreated Chronic Lymphocytic Leukemia

Summary: this is a randomized, multicenter, open-label, phase 3 study to evaluate the efficacy and safety of acalabrutinib versus chlorambucil plus rituximab in subjects with previously untreated chronic lymphocytic leukemia.

patients be randomized in a 1:1 ratio into 2 arms to receive either acalabrutinib monotherapy (arm a) or rituximab in combination with chlorambucil (arm b). the primary objective of this study is to compare the efficacy of acalabrutinib relative to chlorambucil plus rituximab in subjects with previously untreated chronic lymphocytic leukemia without del(17p) or tp53 mutation.

Eligibility criteria:
inclusion criteria: * men and women: (a) ≥65 years of age or (b) \>18 and \<65 years of age, provided that they meet at least one of the following criteria: (i) creatinine clearance 30 to 69 ml/min using the cockcroft-gault equation (iwcll guidelines) (ii) a score higher than 6 on the cumulative illness rating score-geriatric (cirs g) * ecog performance status of 0, 1, or 2 * diagnosis of cll that meets published diagnostic criteria (hallek 2018) * active disease per iwcll 2018 criteria that requires treatment * adequate bone marrow function * adequate renal and hepatic function exclusion criteria: * known detected del(17p) or tp53 mutation * transformation of cll to aggressive non-hodgkin lymphoma (nhl) (eg, richter's transformation, pll, or diffuse large b cell lymphoma \[dlbcl\]), or central nervous system (cns) involvement by leukemia * history of prior malignancy except for the following: (a) curatively treated basal cell carcinoma or squamous cell carcinoma of the skin or carcinoma in situ of the cervix at any time prior to study (b) other cancers not specified above which have been curatively treated by surgery and/or radiation therapy from which subject is disease-free for ≥3 years without further treatment * significant cardiovascular disease * known history of infection with human immunodeficiency virus (hiv) * serologic status reflecting active hepatitis b or c infection * any active systemic infection (eg, bacterial, viral, or fungal infection) requiring systemic treatment * history of stroke or intracranial hemorrhage within 6 months before first dose of study drug * major surgical procedure within 30 days of first dose of study drug * any prior cll-specific therapies * corticosteroid use \>20 mg within 1 week before first dose of study drug, except as indicated for other medical conditions * requires or receiving anticoagulation with warfarin or equivalent vitamin k antagonists * for women only: breastfeeding or pregnant

Keywords: chronic lymphocytic leukemia acalabrutinib progression-free survival
spinetrack registry - spinal outcomes registry

Conditions: Vertebra; Degeneration; Spinal Trauma; Spinal Deformity

Summary: the spine track spinal surgery registry is a prospective multi-center observational data collection initiative, to capture clinical and radiographic outcomes in candidates for spine surgery with degenerative, deformity, and traumatic pathologies. as an observational database, there are no initial driving hypotheses, but rather data will be mined to answer unforeseen questions, but which may include broad topics such as comparative effectiveness between and among various surgical treatment options, and/or outcomes in various subgroups of patients such as defined by demographics, comorbidities, indications and symptoms, treatment variables, and/or outcome variables.


Eligibility criteria:
inclusion criteria: * candidate for spinal surgery
monitoring of incidence of mental discomfort in pregnant women during the serious covid-19 pandemic conditions

Conditions: Pregnant Woman

Summary: this study is aimed to detect severe fear of delivery and its association with the incidence of obsessive-compulsive disorder and symptoms of depression and anxiety in the population of pregnant women in the third trimester during the serious covid-19 pandemic situation in slovakia. data will be acquired from three departments of gynaecology and obstetrics of university hospital bratislava. the majority of pregnancies from the region are managed in this hospital; the total number of deliveries in 2020 achieved 7,835

the pregnancy is a risk factor for the first manifestation of several mental disorders. current serious pandemic situation and a constant risk of covid-19 infection negatively affects the mental state of the population, risk groups of pregnant women in particular. the aim of this project is to discover the incidence of symptoms of depression, anxiety and obsessive-compulsive disorder in association with the fear of delivery in current covid-19 pandemic conditions in slovakia. we also decided to add a short tool for detection of domestic violence among other scales to detect the incidence among slovak pregnant population. all pregnant women in their third trimester who visit the prenatal clinic for their routine weekly check-up will be asked to participate in the study. the questionnaire which comprises of validated mental scales will be handed out to the patients waiting for their examination. after collection of filled questionnaires, those will be later paired with patients' medical documentation and statistically evaluated. the questionnaires will be collected during the period of 1.4.2021-31.3.2022 and statistical analysis will be conducted in the period of 1.4.2022-1.8.2022. it is expected that approximately 1,500 women will be included into the study. all three departments of gynaecology and obstetrics of the university hospital bratislava will participate at the study. in total, approximately 7,800 deliveries a year are managed in the university hospital bratislava. following questionnaires are planned to be used in the study: * wijma delivery expectancy/experience questionnaire - aimed at fear of delivery * pass (perinatal anxiety screening scale) - aimed at anxiety in women before and after delivery * phq-9-sk (patient health questionnaire) - aimed at depressive disorder * hits domestic violence screening tool - aimed at domestic violence * dok (the obsessive-compulsive inventory) - aimed at obsessive and compulsive symptoms * gad-7 (general anxiety disorder-7) - aimed at general anxiety disorder * epds (edinburgh postnatal depression scale) - aimed at symptoms of postpartal depression

Eligibility criteria:
inclusion criteria: * pregnancy after 34th week * vital fetus exclusion criteria: * unwilling to participate * age less than 18 years * foetus mortus or perinatal death of the newborn * low knowledge of slovak language * serious pathology in the pregnancy (e.g. placenta praevia, known congenital disorders)

Keywords: mental state pregnancy covid
early functional training in acute stroke inpatient ward

Conditions: Acute Stroke

Summary: to investigate the difference between two models of an early intervention program (focused on mobility function) in the functional recovery 3 months post stroke in a group of patients with acute ischemic stroke while in acute inpatient ward hospitalization.

patients with acute stroke admit into an acute inpatient ward who meet study criteria and provide institutional-reviewed consent form will be randomly assigned into either model 1 or model 2 of an early functional training program. participants in model 1 group will receive 2 sessions of functional training per day whereas those in model 2 group will receive 1 session of functional training and 1 session of friendly visit and education per day. the following outcomes will be measured at admission, at discharge and at 3 months post stroke: barthel index (bi), postural assessment scale for stroke (pass), mobility scale for acute stroke (masa), and usual gait speed (ugs). the rater is blinded to participants' group membership.

Eligibility criteria:
inclusion criteria: * patient with acute ischemic stroke / ich * referred for early rehabilitation, * aged 20 years or more, exclusion criteria: * able to walk independently and safely at admission, * unable to understand three simple comments, * unable to recovery even with appropriate medical management, * serious condition require icu care, * terminal illness for hospice care, * waiting to transfer to long term care facilities