Kornimate/medical-research-clean huggingface dataset:
a study of adverse events and suspected adverse drug reactions of patients under treatment of apixaban for venous thomboembolism (vte) treatment

Conditions: Thrombosis, Deep Vein; Pulmonary Embolism

Summary: number, type and incidence of adverse events/suspected adverse drug reactions in patients treated with apixaban, according to therapeutic indications approved in mexico.


Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be eligible for inclusion in the study: 1. evidence a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. 2. patients (men and women) \>18 years old. 3. patients who have received at least one dose of apixaban for treatment of deep vein thrombosis (dvt) and pulmonary embolism (pe); prevention of recurrent dvt and pe - exclusion criteria: patients meeting any of the following criteria will not be included in the study: 1. patients who are participating in a clinical trial. 2. hypersensitivity to the active substance or to any of the excipients. 3. active clinically significant bleeding. 4. hepatic disease associated with coagulopathy and clinically relevant bleeding risk, based on hepatic function tests. 5. lesion or condition if considered a significant risk factor for major bleeding. this may include current or recent gastrointestinal ulceration, presence of malignant neoplasms at high risk of bleeding, recent brain or spinal injury, recent brain, spinal or ophthalmic surgery, recent intracranial hemorrhage, known or suspected esophageal varices, arteriovenous malformations, vascular aneurysms or major intraspinal or intracerebral vascular abnormalities. 6. concomitant treatment with any other anticoagulant agent e.g. unfractionated heparin (ufh), low molecular weight heparins (enoxaparin, dalteparin, etc.), heparin derivatives (fondaparinux, etc.), and oral anticoagulants (warfarin, acenocoumarin, rivaroxaban, dabigatran, etc.) except under specific circumstances of switching anticoagulant therapy. 7. pregnancy and breast-feeding. 8. severe acute or chronic psychiatric condition and other significant medical condition. -
acute effects of vinyasa yoga on vascular function

Conditions: Hypertension

Summary: the purpose of this investigation was to determine the acute effects of vinyasa yoga on arterial stiffness, wave reflection, and blood markers in normo- and hyper-tensive adults. to address this aim, fifteen normotensive adults and 15 adults with elevated blood pressure or stage 1 hypertension with a minimum of 3 months of yoga practice experience were enrolled. carotid-femoral pulse wave velocity (cf-pwv), augmentation index (aix), lipid profile, and glucose concentrations were assessed at baseline and immediately following a 1-hour vinyasa yoga session.


Eligibility criteria:
inclusion criteria: * having normal (systolic blood pressure \<120 mm hg with a diastolic \<80 mm hg) or elevated blood pressure (systolic blood pressure 120-129 mm hg) or stage 1 hypertension (systolic blood pressure 130-139 mm hg or a diastolic blood pressure 80-89 mm hg). * must have had at least 3 months of prior yoga experience. exclusion criteria: * a history of cardiovascular disease or cardiac events, pregnancy, infection within the last 4 weeks, chronic obstructive pulmonary disease (copd), endocrine or renal disease, metabolic disorders, or debilitating muscular, joint and bone injury.
endothelin receptor function and acute stress

Conditions: Hypertension

Summary: our bodies respond differently to stress. animal studies by the investigators have found that endothelin-1 plays a role in regulating blood pressure in response to stress. this study is an extension of the investigators previous animal work to evaluate the role of endothelin-1 during stress in humans.

using a salt sensitive animal model of prehypertension, the dahl s rat,the investigators have previously published that acute stress elicits a pressor response that is accompanied by an increase in 8 isoprostane and endothelin-1. however, the pressor response is suppressed by endothelin a/b receptor antagonism. moreover, the investigators have identified that the increase in 8-isoprostane occurs downstream of endothelin receptor activation. these data indicate that endothelin receptor activation is a main player in the pressor response to acute stress in pre-hypertensive animals; however, this phenomenon has yet to be elucidated in humans.

Eligibility criteria:
inclusion criteria: * men and premenopausal women (ages 18-50 years old) * self-reported black and white adults * lean adults (bml \<25 kg/m\^) * obese adults (bml \> 30 kg/m\^) exclusion criteria: * having a bmi less than 16 kg/m2 (severely and very severely underweight) or that is greater than 40 kg/m2 (class iii obesity) * having evidence of cardiovascular, pulmonary, renal, hepatic, cerebral, or metabolic disease * having evidence of pregnancy * using medications that affect vascular tone (i.e., nitrates, etc.) * postmenopausal women * uncontrolled hypertension * individuals who are on a restricted salt diet * having a history of chronic pain * having a history of rheumatoid arthritis * using medications that are contraindicated with bosentan (i.e. glyburide, cyclosporine) * liver dysfunction (which may be identified with the blood sample we take)

Keywords: arterial stiffness flow-mediated dilation endothelial function pulse wave velocity inflammation oxidative stress nitric oxide cold pressor test physio flow bosentan endothelin receptor endothelin-1 bmi stress blood pressure
evaluation of allocetra by intra-articular injection for the treatment of psoriatic arthritis

Conditions: Arthritis, Psoriatic

Summary: this is an open label study to evaluate the safety and initial efficacy of intra-articular administration of allocetra in patients with psoriatic arthritis (psa).

psoriatic arthritis (psa) is a prevalent chronic inflammatory disease that mainly affects the synovial joints, and leads to inflammatory arthritis, in addition to skin manifestations. if left untreated, inflammatory arthritis leads to joint damage and deformities. allocetra is an immunomodulatory cell-based therapy consisting of allogeneic peripheral blood mononuclear cells that have been modified to be engulfed by macrophages and reprogram them into their homeostatic state. as macrophages play a crucial role in the initiation of psa immunopathogenesis, they are considered an emerging target for psa treatment. this study will assess the safety of allocetra injection to the joint (knee, elbow or ankle) in patients with psa, and evaluate the preliminary responses to treatment.

Eligibility criteria:
inclusion criteria: 1. diagnosed with psa. 2. stage 1 patients: at least one joint resistant to standard psa treatments and on a stable dose of approved psa treatment for at least 3 months prior to treatment. 3. stage 2 patients: at least one symptomatic joint following attempt of intra-articular injection of corticosteroids, with insufficient response. 4. acceptable blood tests- complete blood count (cbc), electrolytes, adequate renal function, adequate liver function. exclusion criteria: 1. prior intra-articular injection to the target joint of steroids, hyaluronate or other drugs within 3 months prior to treatment. 2. any significant injury to the target joint within the 6 months prior to treatment, or any surgery to the target joint within the 12 months prior to treatment. 3. findings of acute fractures, severe loss of bone density, chondrocalcinosis and/or severe bone or joint deformity in the target joint. 4. evidence of active local infection in the target joint. 5. concomitant rheumatic, inflammatory or autoimmune disease other than psa. 6. other limb pain of unknown etiology. 7. any evidence of clinically significant active infection. 8. major medical condition as detailed in the protocol.
pulmonary arterial denervation in patients with pulmonary hypertension associated with the left heart failure

Conditions: Pulmonary Hypertension

Summary: a number of 100 patients with pulmonary hypertension associated with the left heart failure scheduled for elective pulmonary arterial denervation (padn) are randomized 1:1 to either padn or control group.

heart failure patients must have completed the right heart catheterization. all the patients accepted the optimal medical therapies,including diuretics, nitrate esters, β-blockers, ace inhibitors or receptor blocker aldosterone antagonists and/or digoxin).the patients of pulmonary hypertension are defined into two groups: "passive" pulmonary hypertension(mpap≥25 mmhg, pcwp\>15 mmhg and pulmonary vascular resistance\ 15 mmhg and pulmonary vascular resistance \>3 woods unit) increase in resistance due to either pulmonary vasoconstriction or structural changes in the pulmonary vasculature. all the "reactive" pulmonary hypertension patients are eligible for the randomized study in padn group or control group according to the computer generated random table.

Eligibility criteria:
inclusion criteria: * age\>18yr * "reactive"pulmonary hypertension in left heart failure: mpap≥25 mmhg, pcwp\>15 mmhg and pulmonary vascular resistance (pvr) \[the pvr =(mpap-pcwp)/ carbon monoxide\]\>3.0 woods unit * voluntary acceptance of all follow-up assessment of program requirements. exclusion criteria: * who group i, iii, iv, v pulmonary artery hypertension * severe renal dysfunction (ccr\<30 ml/min) * blood platelet count\<100,000/l * expected life span\<12-month * in pregnancy * systematical inflammation * malignant cancer(s) * tricuspid valve stenosis, supra-pulmonary valve stenosis * allergic to studied drugs or metal materials

Keywords: pulmonary hypertension pulmonary arterial denervation left heart failure 6-min walk distance
health promotion and fitness for younger and older adults with smi

Conditions: Schizophrenia; Bipolar Disorder; Schizoaffective Disorder

Summary: the goal of this project, which has not changed, is to improve the health and fitness of persons with serious mental illness (smi) using an innovative model: in shape lifestyles. participants are randomly assigned to the in shape program or health club membership and education only. the three specific aims of this study are to: 1. to compare the treatment groups with respect to improvement in physical fitness outcomes, including: (a) health behaviors (engagement in exercise and diet changes); and (b) indicators of physical fitness. 2. to compare the treatment groups with respect to improvements in mental health outcomes, including negative symptoms, depression, and self-efficacy. 3. to explore differences in the treatment groups with respect to psychosocial functioning, health status, and acute service use, and the effects of selected demographic, clinical, and health behavior variables on primary outcomes.

individuals with smi die 10-25 years earlier than the general population and have disproportionately greater rates of medical comorbidity and disability associated with high rates of obesity, sedentary lifestyle, metabolic syndrome, and poor dietary habits. despite greater costs and adverse outcomes associated with the combination of mental illness and poor physical health, little attention has been paid to the development of health promotion interventions designed to address the needs of the high-risk group of people with smi. this study is testing an innovative approach to reducing these problems and developing a program that will potentially have a downstream effect on early mortality for the vulnerable population of people with smi.

Eligibility criteria:
inclusion criteria: * age 21 or older * serious mental illness defined by an axis i diagnosis of major depression, bipolar disorder, schizoaffective disorder, or schizophrenia * persistent impairment in multiple areas of functioning (e.g., work, school, self-care) * body mass index (bmi) greater than 25 * able and willing to provide informed consent * on stable pharmacological treatment (same psychiatric medications over prior 2 months) exclusion criteria: * residing in nursing home or other institution * diagnosis of dementia or significant cognitive impairment (mmse\<24) * unable to walk one city block * pregnant or planning to become pregnant within the next 18 months * unable to speak english * terminal illness with life expectancy\<1 year * current diagnosis of an active substance dependence disorder

Keywords: community mental health health coach weight loss fitness serious mental illness health promotion
improving hospitalizations for children with asd

Conditions: Autism Spectrum Disorder; Autistic Disorder

Summary: this study aims to implement and test a specific brief applied behavior analysis model for assessing and responding to severe challenging behavior during acute medical and behavioral hospitalization for children with asd. the investigators will evaluate the impact of this program by conducting a randomized trial across both medical and psychiatric hospital settings.


Eligibility criteria:
inclusion criteria: * documented diagnosis of an asd based on clinical dsm-5 diagnostic criteria assessed by attending psychiatrist * the presence of a significant challenging behaviors (e.g., aggression, property destruction, self-injury, elopement) * admission to the vph or medical floors * individual and caregiver agreement to participate and ability to provide informed consent (and assent). exclusion criteria: * none

Keywords: autism spectrum disorder autism
type 3 predictive observational study for sensory profiles in central sensitization in low back pain population.

Conditions: Sensory Profiles, Nociplastic Pain, Low Back Pain

Summary: this study conducts prognostic research to develop, validate, and evaluate the predictive role of sensory profiles in the development of sensory profiles over time. therefore, a type 3 prognostic model research will be conducted in the low back pain population.

this is a longitudinal multi-centre prospective cohort study design with two measurements.the strobe statement is used as guideline and the results are reported according to the tripod, and remark checklists. the study is a type iii prognostic model research study, following the progress framework to assess the outcome by the development, validation, and evaluation of the impact of incorporating single or multiple prognostic factors, and their prognostic value at baseline in the development of cs over a period of 12 weeks.

Eligibility criteria:
inclusion criteria: * patients with acute lbp (\< six weeks) * with or without radiating pain * aged 18 to 60 years * a pain-free episode for at least 12 weeks before the onset of their current back pain. * be able to read and understand the dutch language. exclusion criteria: * any specific cause of low back pain

Keywords: sensory profiles, central sensitization, low back pain.
vitamin d 2 to dialysis patients

Conditions: Kidney Disease; Muscle Weakness; Pain; Fractures, Bone

Summary: vitamin d is necessary for healthy bones. vitamin d is made in our skin when we are exposed to sunlight, but it is also found in foods that we eat and in vitamin pills. low levels of vitamin d are common in many groups of people, because we do not get enough sun during the winter and because we eat few foods that have vitamin d in them. some foods with vitamin d are salmon, mackerel, tuna, and fortified milk, which has had vitamin d added to it. we know that nearly all kidney disease patients on dialysis do not have enough vitamin d in their bodies. we believe this condition can cause muscle weakness, leading to falls and broken bones. these are common problems for patients who are receiving dialysis. for example, dialysis patients have a much higher risk of hip fractures (broken hips). however, no formal research has been done on patients with low vitamin d levels receiving dialysis, to see if they actually have muscle weakness and related problems. there are two goals of this study. first, we want to see if patients on dialysis who have low vitamin d levels are actually at risk for muscle weakness, muscle pain, and broken bones. we also want to find out if giving vitamin d pills to these patients will result in better muscle strength, less muscle pain, and fewer falls. in this study, we will compare vitamin d to placebo. placebo capsules look exactly like vitamin d capsules but contain no active ingredients. we use placebos in research studies to be sure that the study results are due to the study drug and not to other reasons.

inclusion criteria: age ³ 18, ckd on hemodialysis, men and women, hemoglobin ³ 9g/dl, albumin ³ 3.0g/dl, no recent (in the last three months) admissions to the hospital, ability to walk ten feet with or without a walking aid. exclusion criteria: subjects who are pregnant or lactating; subjects with history of kidney stones, malabsorption syndromes, tertiary hyperparathyroidism defined by a parathyroid hormone of \>500pg/ml, current use of corticosteroids, non-ambulatory subjects (for example paraplegic subjects), serious fracture in the last three months, and corrected calcium levels of 10.5 mg/dl or greater.

Eligibility criteria:
inclusion criteria: * age ³ 18 * ckd on hemodialysis * men and women * hemoglobin ³ 9g/dl, albumin ³ 3.0g/dl, * no recent (in the last three months) admissions to the hospital * ability to walk ten feet with or without a walking aid. exclusion criteria: * subjects who are pregnant or lactating * subjects with history of kidney stones * malabsorption syndromes * tertiary hyperparathyroidism defined by a parathyroid hormone of \>500pg/ml, current use of corticosteroids * non-ambulatory subjects (for example paraplegic subjects) * serious fracture in the last three months, and * corrected calcium levels of 10.5 mg/dl or greater.

Keywords: chronic kidney disease dialysis vitamin d chronic kidney disease is associated with impaired muscle strength, pain and fractures.
non-pharmacological analgesic effects on term newborns

Conditions: Pain; Breast Feeding

Summary: the purpose of this study is to compare the analgesic effects of four non-pharmacological interventions: skin-to-skin contact, breastfeeding, oral sucrose and nonnutritive sucking in newborns receiving a heel lance procedure.

this is an randomized control clinical study. study population is healthy term newborns.patients were identified by chart review and consent was received by nurse researcher. newborns were randomized into either the control group who received no pain intervention or the intervention group who received one of four non-pharmacological pain interventions: skin to skin contact, breastfeeding, oral sucrose, and nonnutritive sucking. a heel lance for newborn screen blood sampling was selected as a study procedure and performed by a hospital technician following standard protocol. pain scoring was assessed by two research nurses after the hell lance and through the procedure. neonatal pain, agitation and sedation scale (npass) was selected as a pain assessment tool for this study. the average pain score from two research nurses were used for statistical analysis.

Eligibility criteria:
inclusion criteria: * gestational age 38-40 * 2.5-4.0kg * 24-48hours of age * receiving heel lance procedure * apgar\>7 at birth * npass\<3 at time of heel lance exclusion criteria: * prior heel lance procedure * birth trauma * forceps or vacuum delivery * maternal drug abuse during delivery

Keywords: neonates non-pharmacological
evaluation of argatroban injection in pediatric patients requiring anticoagulant alternatives to heparin

Conditions: Thrombocytopenia; Thrombosis

Summary: the purpose of this study is to evaluate the safe and effective dose of argatroban for prophylaxis and/or treatment of thrombosis in pediatric patients with current or previous diagnosis of heparin-induced thrombocytopenia (hit) and thrombosis syndrome (hitts), or who in the opinion of the investigator require alternative anticoagulation due to an underlying condition.


Eligibility criteria:
criteria for inclusion: * males and females ages birth to 16 years,inclusive, at enrollment. for neonates, the minimum corrected gestational age should be 37 weeks. * documented hit defined as a fall in platelet count to less than 100,000/ul or a \>=50% decrease in platelets after the initiation of heparin therapy with no apparent explanation other than hit, or * require anticoagulation and have a documented history of a positive hit test in the absence of current thrombocytopenia (i.e. patients at risk for hit), or * in the opinion of the investigator, require alternative anticoagulation due to an underlying condition, such as at-iii deficiency or heparin resistance. * signed (written) informed consent or assent by the patient (if age appropriate) and the patient's parent or guardian. criteria for exclusion: * any condition which, in the investigator's opinion, would contraindicate the use of argatroban or would endanger the patient if he/she participated in this trial. * unexplained aptt \> 2 times the upper limit of normal at baseline, in the absence of heparin. * international normalized ratio (inr) \>1.6 at baseline in the absence of warfarin. * known clinical site of bleeding or predisposition to bleeding (e.g., gi bleed, hematuria, hemorrhagic cva,retroperitoneal hematoma, diabetic retinopathy, hemorrhagic pericardial effusion, or hemorrhagic pleural effusion. patients who have a known clinical site of bleeding may be enrolled if the investigator deems the risk of continued thrombosis to outweigh the potential bleeding risk. * any patient who has received any investigational medication within 30 days prior to the first dose of study medication or who is scheduled to receive an investigational drug other than argatroban during the course of the study. * known hypersensitivity to argatroban or chemically related compounds. * females of childbearing potential who are pregnant (positive serum beta-hcg), breast feeding, or sexually active and not taking adequate contraceptive precautions (e.g. iud or oral contraceptives). * any patient receiving a thrombolytic medication (e.g. tpa). * any neonate with a corrected gestational age of \< or = 44 weeks and bleeding in the head (grade i or above) as determined by head ultrasound.

Keywords: heparin-induced thrombocytopenia heparin-induced thrombocytopenia and thrombosis hit hitts anticoagulation