Kornimate/medical-research-clean huggingface dataset:
the effect of pranayama exercise

Conditions: Pranayama; Exercise; Anxiety; Death; Sleep

Summary: objective: this randomized controlled experimental study aimed to investigate the effects of pranayama exercises on vital signs, anxiety, fear of death, and sleep quality in patients who have experienced an acute myocardial infarction. materials and methods: the study sample consisted of 80 patients diagnosed with acute myocardial infarction who were hospitalized in the coronary intensive care unit of istanbul university cerrahpaşa medical faculty hospital the patients were randomly assigned to either the experimental (n=40) or control group (n=40) using a computer-based randomization method. data collection tools included the personal information form, beck anxiety inventory, death anxiety scale, and pittsburgh sleep quality index.

objective: this randomized controlled experimental study aimed to investigate the effects of pranayama exercises on vital signs, anxiety, fear of death, and sleep quality in patients who have experienced an acute myocardial infarction. materials and methods: the study sample consisted of 80 patients diagnosed with acute myocardial infarction who were hospitalized in the coronary intensive care unit of istanbul university cerrahpaşa medical faculty hospital between june and november 2024. the patients were randomly assigned to either the experimental (n=40) or control group (n=40) using a computer-based randomization method. data collection tools included the personal information form, beck anxiety inventory, death anxiety scale, and pittsburgh sleep quality index.

Eligibility criteria:
inclusion criteria: voluntary participation in the study age ≥18 years diagnosed with ami cognitive ability to perform pranayama exercises ability to comprehend and respond to survey questions no communication impairments exclusion criteria: * having respiratory diseases * low saturation \<95

Keywords: pranayama exercise anxiety death sleep
puma (paediatric osseous marrow assessment)

Conditions: Leukaemia

Summary: this is a pilot cancer imaging study investigating change in the apparent diffusion coefficient (adc) at a single time point post-transplantation in patients. the treatment is bone marrow transplant as per standard patient care, without change for trial purposes. its main aim is to evaluate the engraftment of bone marrow after transplantation performing functional magnetic resonance imaging (mri) of the lumbar spine and pelvis at baseline and after 2-3 weeks after the transplantation (according to the appearances of raised white blood cells).this will enhance the understanding of bone marrow features on imaging at engraftment and improve the management of children/young adults who suffer acute leukaemia. following allogenic haemopoietic stem cell transplantation, changes in bone marrow apparent diffusion coefficient (adc) are measurable at the point of engraftment and in conjunction with peripheral blood counts may provide a future biomarker of successful clinical outcome.

this is a single-center pilot study. the investigators intend to image 12 inpatients, aged 5-24 years old who are scheduled for haemopoietic stem cell transplantation. patients will have two mri scans requiring them to lie in the scanner for approximately 15 minutes. patients unable to tolerate lying flat for this length of time or to tolerate the scan for any reason will be withdrawn from the study. if required a play specialist can be organised to help the young patients feel more at ease in the mri department. mri does not involve radiation exposure and when performed within national safety guidelines do not pose a significant risk. patients with contraindications to mri such as pacemakers, certain metal implants and claustrophobia will not be recruited. every effort will be made to book scan appointments to coincide with clinic visits. scans will be reported as per clinical procedures and data will be made available to the referring consultants immediately via the radiology picture archiving and communications system (pacs).

Eligibility criteria:
inclusion criteria: 1. all patients with relapsed or high risk acute lymphoblastic or myeloblastic leukaemia planned for haemopoietic stem cell transplantation 2. cooperative paediatric individuals and young adults (5-24-years-old) not requiring general anaesthesia or sedation for the purpose of mri 3. able to lie flat throughout the scan exclusion criteria: 1. non cooperative patients 2. ferromagnetic implants, contraindicating mri 3. claustrophobia 4. unable to lie flat throughout the scan 5. uncertain histological diagnosis 6. musculoskeletal disorders 7. metabolic disorders 8. lack of signed parental consent and patient's verbal approval

Keywords: magnetic resonance imaging (mri) leukaemia whole-body diffusionweighted-magnetic resonance imaging (wb dw-mri) paediatrics
enhancing quality of life for nursing home residents

Conditions: Alzheimer's Disease

Summary: many persons with dementia exhibit behaviors that caregivers find difficult to manage. the purpose of this study is to test the effectiveness of individualized recreational activities for reducing agitation and passivity in persons with dementia.

most persons with dementia exhibit behavioral symptoms, such as agitation and passivity, at some time in the course of their illness. these behaviors are a source of caregiver burden and often precipitate nursing home placement. there are a number of drugs that can be used to treat these behaviors, but they are costly and have serious adverse effects in a sizable number of people. non-drug interventions, such as recreational activities, are recommended as the first line of treatment for behavioral symptoms. however, we don't know which activities are most effective for individual residents. the "one size fits all" approach has not been very effective. we are testing an approach that individualizes activities for residents based on their personality style of interest and functional level. we anticipate that this approach will be more effective for reducing behavioral symptoms than routine activities given to all residents. consenting residents are assessed for personality and functional level and are videotaped during a baseline period and during activities so we can reliably measure behaviors, affect and engagement.

Eligibility criteria:
inclusion criteria: * english speaking; diagnosis of dementia; a willing informant who knows the subject well and who can provide past personality and other data; a stable dose of any psychoactive drug from pre-baseline through final observation; and presence of agitation or passivity. exclusion criteria: * delirium or an unstable medical condition; history of parkinson's disease, huntington's disease, seizure disorder, stroke, alcoholism, drug abuse, head trauma with loss of consciousness, or psychiatric illness preceding the onset of memory loss; severe vision or hearing impairment; and receiving a new psychoactive medication within the past 30 days.
registry for cadasil

Conditions: Cerebral Autosomal Dominant Ateriopathy With Subcortical Infarcts and Leukoencephalopathy

Summary: this study is being done in order to create a registry (list) of people interested in cerebral autosomal dominant arteriopathy with subcortical infarcts and leukoencephalopathy (cadasil) research. it may be that you have a family member or other loved one with cadasil, or that you may have cadasil or are at risk. participation means that your name will be added to a list of people who will be invited to participate in future research studies on cadasil. participants must be 18 years or older, and will remain on the registry until they request to be removed.

the purpose of this registry is to allow dr. jane paulsen and her cadasil research teams to contact individuals on the list who may fit a study's eligibility requirements. all individuals interested in cadasil research who either have a family member or loved one, or are at risk themselves, are eligible to participate in this registry. information collected as part of the registry will be used solely to determine potential participant's eligibility to participate research. a patient registry is an organized system that uses observational study methods to collect uniform data (clinical and other) to evaluate specified outcomes for a population defined by a particular disease, condition, or exposure, and that serves a predetermined scientific, clinical, or policy purpose(s).

Eligibility criteria:
inclusion criteria: * 18 years of age or older * have a loved one or a family member with cadasil, or are at-risk for cadasil themselves exclusion criteria: * under 18 years of age

Keywords: cadasil
comparison of ticagrelor pharmacokinetics and pharmacodynamics in stemi and nstemi patients

Conditions: Myocardial Infarction

Summary: the purpose of the pinpoint study is to compare pharmacokinetics (pk) and pharmacodynamics (pd) of ticagrelor in st-elevation myocardial infarction (stemi) and non-st-elevation myocardial infarction (nstemi) patients designated to invasive strategy. data regarding comparison of pk and antiplatelet action of ticagrelor in stemi and nstemi are sparse. recommended dosing regimens of ticagrelor are identical for both stemi and nstemi, although it is not known whether pk and pd features of ticagrelor are uniform in these patients.

the european society of cardiology and american heart association guidelines recommend use of ticagrelor or prasugrel as a treatment of choice in patients with both stemi and nstemi (class of recommendation i, level of evidence b). recommended dosing regimens of ticagrelor are identical in stemi and nstemi patients, although epidemiology, clinical approach and early outcomes differ between these two types of myocardial infarction. it is not known whether pk and pd features of ticagrelor are uniform in stemi and nstemi patients. however, the existing body of evidence suggest that pk and pd of ticagrelor may be attenuated in stemi patients compared to healthy subjects and patients with stable coronary artery disease, which may expose stemi patients at increased risk of developing thrombotic complications secondary to insufficient platelet inhibition. the pinpoint study could provide a valuable insight into the knowledge regarding ticagrelor action in stemi vs. nstemi patients. since there is no reference study comparing pharmacokinetics of ticagrelor in stemi and nstemi patients, we decided to perform an internal pilot study of approximately 30 patients (15 patients with each type of myocardial infarction) for estimating the final sample size.

Eligibility criteria:
inclusion criteria: * provision of informed consent prior to any study specific procedures * diagnosis of acute st-segment elevation myocardial infarction or acute non-st-segment elevation myocardial infarction * male or non-pregnant female, 18 years old and older * provision of informed consent for angiography and pci exclusion criteria: * treatment with ticlopidine, clopidogrel, prasugrel or ticagrelor within 14 days before the study enrollment * hypersensitivity to ticagrelor * current treatment with oral anticoagulant or chronic therapy with low-molecular-weight heparin * active bleeding * history of intracranial hemorrhage * recent gastrointestinal bleeding (within 30 days) * history of coagulation disorders * history of moderate or severe hepatic impairment * history of major surgery or severe trauma (within 3 months) * second or third degree atrioventricular block during screening for eligibility * patient required dialysis * manifest infection or inflammatory state * killip class iii or iv during screening for eligibility * respiratory failure * current therapy with strong cyp3a inhibitors or strong cyp3a inducers

Keywords: ticagrelor stemi nstemi pharmacokinetics pharmacodynamics
high altitude (ha) residents with pulmonary vascular diseases (pvd), 6 minute walk distance (6mwd) assessed at 2840m (ha) with and without supplemental oxygen therapy (sot)

Conditions: Pulmonary Vascular Disease; Pulmonary Artery Hypertension; Chronic Thromboembolic Pulmonary Hypertension

Summary: the investigators aim to study the effect of sot in participants with pulmonary vascular diseases (pvd) defined as pulmonary arterial hypertension or chronic thromboembolic pulmonary hypertension (ph) who permanently live \>2500m on 6-minute walk distance (6mwd) assessed at 2840m.

participants with pvd diagnosed with precapillary ph with right heart catheterization and classified to groups 1 and 4 (pah or cteph) who permanently live at ha \>2500 (pvdha) will have 6-minute walk distance near their living altitude in quito at 2840m with and without sot at 3l/min via nasal cannula according to a randomized cross-over design.

Eligibility criteria:
iinclusion criteria: * adult patients 18-80 years old of both genders, * residence \> 2500m of altitude * diagnosed with precapillary ph (mean pulmonary artery pressure (mpap) \>20 mmhg, pulmonary artery wedge pressure (pawp) ≤15 mmhg and pulmonary vascular resistance (pvr) ≥2 wood units (wu) by right heart catheterization) with ph being classified as pah or cteph according to guidelines * patients stable on therapy * new york heart association (nyha) functional class i-iii * provided written informed consent to participate in the study. exclusion criteria: * age \ 80 years * unstable condition * patients who cannot follow the study investigations, patient permanently living \< 2500m. * patients with moderate to severe concomitant lung disease (fev1\ 20 cigarettes/day) * severely hypoxemic patients at quito permanently have persistent oxygen saturation by pulseoximetry (spo2) \<80% on ambient air. * patients with chronic mountain sickness (hemoglobin \> 19 g/dl in women, \>21 g/dl in men) * patient with a non-corrected ventricular septum defect * relevant concomitant other disease of the heart, kidney, liver, blood (anemia hemoglobin\<11 g/dl)

Keywords: pulmonary hypertension hypoxia supplemental oxygen therapy pulmonary arterial hypertension chronic thromboembolic pulmonary hypertension high altitude pulmonary vascular disease
effect of an inhibitor of cholesterol absorption on vitamin d levels

Conditions: Vitamin D Deficiency

Summary: double-blind randomized controlled trial to evaluate the serum levels of 25(oh)d after a single oral dose of cholecalciferol 50,000 iu plus ezetimibe or placebo. differences between the serum levels of 25(oh)d in response to cholecalciferol plus ezetimibe compared to cholecalciferol plus placebo.

objectives: to evaluate the serum levels of 25(oh)d after a single oral dose of cholecalciferol 50,000 iu plus ezetimibe or placebo. experimental design: double-blind randomized controlled trial. research location: porto alegre clinical hospital (hcpa), rs, brazil. participants: medical residents of the hcpa. intervention: the groups will be randomized to ezetimibe 10 mg for 5 days or placebo. on the fifth day, they should came after an overnight fast for blood tests collection \[25(oh)d, pth, calcium, albumin\]. next, all participants will receive orally a cholecalciferol 50,000 iu capsule and a snack containing 15g of fat. participants will return 14 days after that for a second blood test. statistical analysis: paired samples t-test or wilcoxon signed rank-test will be used for comparing variables in two distinct moments (before cholecalciferol and 14 days after). the correlation between the numerical variables will be evaluated by the spearman's correlation coefficient. a p value of less than 0.05 was considered statistically significant. expected results: differences between the serum levels of 25(oh)d in response to cholecalciferol plus ezetimibe compared to cholecalciferol plus placebo. cost/benefit of the project: this is a low budget and minimal risks study that will contribute to a better understanding of the absorptive process of vitamin d and the effect of ezetimibe on its absorption.

Eligibility criteria:
inclusion criteria: * medical students of the hcpa exclusion criteria: * body mass index \>+ 25 or \< 18.5 kg/m2 * known liver, kidney or endocrine disease * known malabsorption * use of supplements of calcium and/or vitamin danticonvulsants, barbiturates, or glucocorticoids * travel outside the brazilian south region during the previous 120 days

Keywords: vitamin d absorption ezetimibe
long-term follow-up study in patients previously treated with a mustang bio car-t cell investigational product.

Conditions: Blastic Plasmacytoid Dendritic Cell Neoplasm (BPDCN); Chronic Lymphocytic Leukemia in Relapse; Small Lymphocytic Lymphoma, Relapsed; Waldenstrom's Macroglobulinemia Recurrent; Follicular B-cell Non-Hodgkin's Lymphoma; B-cell Lymphoma Refractory; Mantle Cell Lymphoma Recurrent; Hairy Cell Leukemia; Diffuse Large B Cell Lymphoma; Waldenstrom's Macroglobulinemia Refractory; Mantle Cell Lymphoma Refractory

Summary: a long-term follow-up study to assess safety and efficacy in patients previously treated with mustang bio chimeric antigen receptor (car)-t cell investigational products.

non-interventional, multi-center, long-term follow-up study of subjects previously treated with a mustang bio car-t cell investigational product in a mustang bio sponsored clinical study. subjects who enroll will be monitored for a total of up to 15 years from the time of their last investigational product infusion.

Eligibility criteria:
inclusion criteria: * patients previously treated with a mustang bio car-t cell investigational product in a prior mustang bio sponsored clinical study. * patient has provided signed and dated informed consent. exclusion criteria: * none. all patients who have received prior treatment with mustang bio car-t cell investigational product in a mustang bio sponsored clinical study are eligible for this long-term follow up (ltfu) study.

Keywords: long-term follow-up car-t cell therapy mb-102 mb-106
balanced anesthesia for intubation of premature infants

Conditions: Premature Birth

Summary: the study aim is to compare a balanced anesthesia of the medicines used in all other age groups with the routine premedication in use for premature's with regards to the success in the intubation procedure, the need for analgesia during and after intubation and the stress reaction. in addition a pain scale for prolonged stress/pain for premature neonates in nicu-care will be validated, and the individual pharmacogenetic profile in relation to the need of morphine after the intubation will be investigated. the hypothesis is that balanced anesthesia before intubation facilitates the procedure, decreases the amount of stress and pain related to it, and causes a decreased need for analgesia after the intubation.


Eligibility criteria:
inclusion criteria: * \<37 gw at birth * \ 72 hours postnatal age, primary or reintubation * informed consent from parents exclusion criteria: * intubation directly postnatally at the delivery room * asphyxia (apgar \<4 at 10 min, umb-ph \<7,0 * s-potassium \> 6,5 * major malformations * postsurgery intubation * included in an other intervention study first week in life * other intervention study

Keywords: intubation premedication
simvastatin as an augmentation treatment for treatment resistant depression: randomized controlled trial.

Conditions: Treatment Resistant Depression; Major Depressive Disorder

Summary: in this double blind, randomized placebo controlled trial we aim to determine the efficacy of simvastatin as an add-on treatment for treatment resistant depression. we will recruit 150 people with treatment-resistant depression with the aim of determining whether the addition of simvastatin (20mg daily) to treatment as usual (tau) for 12 weeks leads to an improvement in depressive symptom compared with placebo added to tau.


Eligibility criteria:
inclusion criteria: * dsm-5 current major depressive episode * must currently be on an antidepressant and must have had a non-response to \>2 oral antidepressant treatments in the current episode (including the one they are currently taking). * capacity to give informed consent * willing to use adequate contraception * give written informed consent exclusion criteria: * primary psychotic or bipolar disorder * history of intolerance to statins or presence of any contraindication to statins * presence of any serious medical condition or neurological problem * presence of autoimmune or inflammatory disorder * alcohol or drug dependence * active suicidal ideation * pregnant or breast-feeding.
observational study on the long term safety of kuvan® treatment in patients with hyperphenylalaninemia (hpa) due to phenylketonuria (pku) or bh4 deficiency

Conditions: Hyperphenylalaninemia (HPA) Due to Phenylketonuria (PKU) or Tetrahydrobiopterin (BH4) Deficiency

Summary: kuvan® is a synthetic copy of a body's own substance called tetrahydrobiopterin (bh4). bh4 is required by the body to use an amino acid called phenylalanine in order to build another substance called tyrosine. kuvan® received marketed authorisation in europe in december 2008 and is now available in several european countries for the treatment of hyperphenylalaninemia (hpa). the primary objective is to assess the long-term safety in subjects treated with kuvan®. secondary objectives are to provide additional information regarding: * safety in specific subject groups (elderly, pediatric, pregnant women and subjects with renal or hepatic insufficiency). * growth and neurocognitive outcomes for subjects with hyperphenylalaninemia (hpa) who are receiving treatment with kuvan®. * progress and outcome of pregnancy for women with hpa who become pregnant while receiving treatment with kuvan® (these women will be enrolled in a dedicated sub-registry). * assessment of adherence to diet and to kuvan®. * assessment of long-term sensitivity to kuvan®treatment.

this is an observational, multicenter, drug registry study. the study will have a total duration of 15 years, including a 10-year inclusion period. no diagnostic, therapeutic or experimental intervention is involved. subjects will receive clinical assessments, medications and treatments solely as determined by their study physician.

Eligibility criteria:
inclusion criteria: * adult or pediatric subject (no age limit) of either gender with hpa due to pku or bh4 deficiency. * have been shown to be responsive to bh4 or kuvan. (note: for spain only-have been shown to be responsive to bh4 or for the newly diagnosed subjects to be responsive to kuvan as defined in the summary of product characteristics \[smpc\]). * currently being treated with kuvan® at a participating centre. * subject or parent/legal guardian willing and able to provide written signed informed consent and given before any data collection. if a child is old enough to read and write, a separate assent form will be given. exclusion criteria: * known hypersensitivity to kuvan® * legal incapacity or limited legal capacity without legal guardian representation * breast-feeding

Keywords: observational post-authorization safety study on kuvan®.