Kornimate/medical-research-clean huggingface dataset:
adalimumab on preventing post-chirurgic recurrence on crohn´s disease

Conditions: Crohn´s Disease

Summary: the present study objective is evaluate adalimumab efficacy versus azathioprine efficacy on prevention of endoscopic recurrence (rutgeerts index= 2b, 3 or 4) in crohn´s disease patients after 52 weeks of treatment.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age at the time of signing informed consent. * patients with crohn's disease who have undergone an ileocecal/ileocolic resection (l1 or l3). the study and the treatment must be initiated within the two first weeks after the resection (+/- 5 days). * patients with surgical reconstruction by ileocolic anastomosis. * women of childbearing age must not be breastfeeding and must have a negative urine pregnancy test and must agree to use contraceptive methods with a \<1% failure rate (e.g., sexual abstinence, oral contraceptives, double barrier methods, intrauterine devices), unless they only have one partner who is sterile. * patients who have signed and dated the informed consent form before performing any specific screening study procedure. exclusion criteria: * resection that requieres temporal ileostomy. * urgency resection which doesn´t permit the initial assessment protocol completion. * resection due to inactive short indolent stenosis (\<10 cm). * resection with mucosal macroscopic residual disease in anastomosis. * previous intolerance or adverse reaction (moderate or severe) to adalimumab or azathioprine. * any contraindications or unwillingness to perform the scheduled colonoscopies or resonances. * contraindications to adalimumab treatment, among which the following are included: active tuberculosis, severe infections such as sepsis or opportunistic infections, moderate or severe heart failure (nyha class iii or iv), central nervous system demyelinating diseases, history of malignant neoplasm or autoimmune diseases. * severe associated extraintestinal manifestations. * previous postoperative recurrence prevention treatments with adalimumab, asathiprine o mercaptopurine which resulted in failure. * any other disease or patient condition that according to investigator criteria, inadequates patient´s participation in the study.

Keywords: crohn´s disease metronidazole azathioprine adalimumab post-chirurgic recurrence
omega-3 polyunsaturated fatty acids on major depressive disorder in patients with cardiovascular diseases

Conditions: Cardiovascular Diseases; Major Depressive Disorder

Summary: n-3 polyunsaturated fatty acids(n-3 pufas) is important in balancing the immune function and physical health by reducing membrane arachidonic acid (aa) and prostaglandin e2 (pge2) synthesis, which might be linked to the somatic manifestations physical morbidity, such as cardiovascular disease in depression. n-3 polyunsaturated fatty acids appears to be a promising treatment that is safe, beneficial to patients with cardiovascular disease and depression. in this proposal, investigators aim the test the hypothesis that n-3 polyunsaturated fatty acids will be more effective than placebo in treating cardiovascular disease patients with major depression after 12 weeks of intervention.

this is a 3-year study and a randomized, double-blind, and placebo controlled clinical the study. investigators plan to enroll 60 subjects from cardiovascular department of china medical university hospital.participants will be randomized into omega-3 polyunsaturated fatty acids or placebo group.the intervention period is 12 weeks. evaluation of the depressive symptoms ( using hamilton depression scale, ham-d, and beck depression inventory, bdi ) of the subjects who are enrolled into the study will take place at -1st, 0, 2nd, 4th, 8th, 12th week. the plasma level of n-3 polyunsaturated fatty acids, chemokines/cytokines, and electrocardiogram will also be measured at the beginning and at the end of the study.

Eligibility criteria:
inclusion criteria: 1. cardiovascular disease patients 2. the diagnostic and statistical manual of mental disorders (dsm-iv) criteria for major depressive disorder. 3. capacity and willingness to give written informed consent. exclusion criteria: 1. cognitive impairment (mini-mental state examination score \<24) 2. comorbid psychiatric disorders, psychosis, high risk of suicide, current substance use 3. an acute coronary syndrome within previous 2 months, left ventricular ejection fraction (lvef)\<30%, advanced malignancy, or physical inability to participate 4. use of antidepressants, anticonvulsants, lithium, or n-3 polyunsaturated fatty acids supplements 5. coagulation disorders or sensitivity to n-3 polyunsaturated fatty acids

Keywords: cvds cardiovascular diseases n-3 polyunsaturated fatty acids depression
biomarker and thrombogenicity assessment in cardiopulmonary bypass surgery utilizing acute normovolemic hemodilution

Conditions: Bleeding Reduction

Summary: this study will help enhance current understanding of the impact of acute normovolemic hemodilution (anh) administration on transfusion requirements post cardiac surgery, the effect of this procedure on coagulation, and platelet hemostasis, and the amount of chest tube drainage 24 hours post coronary artery bypass graft surgery (cabg) surgery.

acute normovolemic hemodilution (anh) involves the removal of the patients own blood immediately at the induction of anesthesia and replacement of this blood intraoperatively with an equivalent volume of crystalloid or colloid solution in order to dissuade the loss of red blood cell mass, the mechanism of action is dilution of the blood, hematocrit reduction, and reduction of the anticoagulant components of the blood associated with bleeding during cardiopulmonary bypass graft surgery. the collected blood is isolated from the negative effects of the cardiopulmonary bypass machine.. the collected blood is then stored in anticoagulant treated blood bags in the cardiovascular operating room and re-infused into the patient in reverse order of collection at the commencement of surgery, leaving the most cell rich blood to be re-infused into the patient last. this study will evaluate the effect in patients with and without anh utilization on; hemostatic markers, chest tube drainage 24 hours post cabg, and need for allergenic blood transfusion. positive effects on the hemostatic markers of anticoagulation and platelets, reduced chest tube drainage at 24 hours post cabg, and reduced number of transfused red blood cells will indicate a positive correlation with anh utilization during isolated on pump cabg surgery. the benefits of anh utilization in blood conservation will benefit patients by reducing their exposure to allogenic blood transfusion with its myriad side effects.

Eligibility criteria:
inclusion criteria: 1. . subject is 18-85 years old. 2. . subject is hemodynamically stable 3. . the subject is able to read and has signed and dated the informed consent document including health insurance portability and accountability act of 1996 (hipaa) authorization permitting release of personal health information as approved by the investigator's institutional review board (irb). exclusion criteria: 1. . hematocrit \<30 at baseline 2. . insufficient (low) on pump hematocrit of \< 21% 3. . patient is hemodynamically unstable 4. . patient requiring an emergency procedure 5. . left main coronary artery stenosis with evidence of hemodynamic instability (e.g.. hypotension, st segment elevations on electrocardiogram) 6. . aortic valve stenosis with evidence of hemodynamic instability (e.g.. hypotension, st segment elevations on electrocardiogram)

Keywords: acute normovolemic hemodilution
stopping biological therapy in pcd study

Conditions: Perianal Crohn Disease; MRI; Biological Therapy

Summary: the purpose of this which studied the biological therapy can be safely withdrawn in perianal crohn's disease patients with radiologically healed fistula on mri pelvis.

this clinical trial in perianal crohn's disease patients with radiologically healed fistula on mri pelvis which studied the biological therapy can be safely withdrawn. the primary endpoint is clinical relapse at 12 months.

Eligibility criteria:
inclusion criteria: * 1. at least 18 years old 2. have a confirmed diagnosis of perianal crohn's disease according to established clinical, endoscopic, radiological and histologic criteria 3. on biological therapy (anti-tumour necrosis factor, anti-integrin, anti-il12/23) for at least 6 months 4. confirmation of radiologically healed perianal crohn's fistulas on mri pelvis within the past 12 months by experienced radiologists 5. in steroid-free clinical remission for at least 6 months with fecal calprotectin \<250 μg/g 6. stable doses of immunosuppressants for at least 3 months if immunosuppressants are used 7. written informed consent exclusion criteria: * 1. history of severe acute or delayed infusion reaction to biological therapy 2. fistulising crohn's disease to organs other than perianal crohn's fistula (fistulation to skin, intestines, bladder etc.) 3. prior history of diverting ileostomy, colostomy, proctocolectomy or proctectomy 4. known pregnancy 5. terminal illness

Keywords: pcd
the effect of using a birth ball and squatting position during labor

Conditions: Labor Pain; Labor Fast; Satisfaction, Patient

Summary: the aim of the study was to evaluate the effect of using the birth ball and squatting position during labor on labor pain, duration of labor and satisfaction. the research is a randomized controlled experimental study. the sample of the study consisted of a total of 159 pregnant women, 53 in the birthing ball application group, 53 in the squatting group, and 53 in the control group, who met the criteria for inclusion in the study.


Eligibility criteria:
inclusion criteria: * no risky pregnancy * gestational week between 37-42 * unopened amniotic membrane * those who will give birth vaginally * in active phase * fluent in turkish * singleton pregnancy * primiparous exclusion criteria: * any complication development * cesarean section status

Keywords: labor pain birth ball squatting duration of labor satisfaction
efficacy and safety of diclofenac sodium topical gel 1% applied 4 times daily in subjects with acute ankle sprain

Conditions: Ankle Sprain

Summary: the purpose of this study is to evaluate the efficacy of diclofenac sodium topical (dsg) 1% compared with placebo applied four times a day in subjects with acute ankle sprains under 'in-use' conditions, in particular with regard to pain relief.


Eligibility criteria:
inclusion criteria: 1. male or female aged 18 years and over. 2. acute sprain of the lateral ankle, grade i-ii, meeting baseline pain intensity level. 3. injury within past 12 hours. exclusion criteria: 1. pain medication was taken within the 6 hours that precede randomization. 2. during the past 3 months: grade i-iii sprain of the same ankle. 3. during the past 6 months: grade ii-iii sprain, any other significant injury (such as fracture or torn ligament), or surgery (except for skin or nails) of the same ankle or foot. 4. pain or instability in the same ankle attributable to previous ankle sprain or any other trauma. 5. ankle sprain attributable to a known disease affecting the ligaments, such as ligament hyperlaxity due to connective tissue disease (e.g., marfan's syndrome, down's syndrome, ehlers-danlos syndrome). other protocol-defined inclusion/exclusion criteria may apply

Keywords: ankle sprain, soft tissue injury
effect of virtual reality application applied to patients with total knee replacement at different times

Conditions: Anxiety; Recovery Quality

Summary: the aim of this study was to examine the effect of virtual reality application on anxiety and quality of recovery at different times (preoperatively and intraoperatively) in patients undergoing total knee replacement.

the elderly population in the world and in our country is gradually increasing and the aging process is prolonged due to the prolongation of life expectancy. osteoarthritis is one of the important obstacles limiting low quality of life and physical freedom in this aging process. it is estimated that osteoarthritis affects over 250 million people worldwide. osteoarthritis is one of the important causes of severe pain and disability due to limitation of mobility, and this disease is a disease that causes deterioration in the psychological well-being of individuals and a low quality of life. the presence of symptoms characterized by joint pain, stiffness and limitation of movement in osteoarthritis negatively affects the quality of life of individuals. one of the most common problems in our country is osteoarthritis of the knee. in the treatment of osteoarthritis of the knee, total knee replacement surgery is performed as a last resort if pharmacologic and non-pharmacologic methods do not yield a positive response. patients with total knee replacement may be exposed to anxiety and pain in this process. in previous studies, positive results were found when the effects of virtual reality application on pain were examined. the aim of this study was to examine the effect of virtual reality application on anxiety and quality of recovery at different times (preoperatively and intraoperatively) in patients undergoing total knee replacement. in previous studies, it was determined that virtual reality application was mostly applied preoperatively and examined pain and vital signs. there are no studies on quality of recovery

Eligibility criteria:
inclusion criteria: * over the age of 18 * no psychiatric medication * no mental and cognitive disabilities * those who underwent total knee replacement, exclusion criteria: * patients with visual and hearing impairment * receiving general anesthesia * experiencing complications during surgery

Keywords: virtual reality anxiety recovery quality total knee replacement nursing
study and analysis of biomechanical parameters of human movement based on disability indicators in older adults

Conditions: Disability

Summary: older adults develop modifications in the execution of movement that lead to impairments in activities of daily living performance. accordingly, there is a need for technological advances in devices that assist older adults targeting improvements in parameters of movement performance that have the highest impact on the skills of daily living. therefore, to gather the parameters of movement impacting daily living activities, the main goal of this study is to perform a comparative analysis of the biomechanical movement parameters between older adults with and without disability, performing the tasks: gait, sit-to-stand, timed up and go, quiet standing and climb and descend stairs. this work was supported by thefundação para a ciência e tecnologia (fct), \[grant number 2020.05356.bd\] and through r\&d units funding \[uidb/05210/2020\], fundação para a ciência e tecnologia (fct), portugal and the european union.


Eligibility criteria:
inclusion criteria: * older adults, 60 years or over; * community-dwelling; * able to perform the tasks (gait, sit-to-stand, climb and descend stairs) independently; exclusion criteria: * older adults who are institutionalized; * older adults who have established diagnosis of malignancy or terminal diseases with an anticipated survival of less than 1 year; * older adults who have stroke history, cerebral hemorrhage, head trauma, or parkinson's disease; * older adults who have cognitive impairment, specifically mini mental state examination (portuguese version) score of 22 for 0 to 2 years of literacy, 24 for 3 to 6 years of literacy and 27 for more than 6 years of literacy (morgado et al., 2009); * older adults who have rheumatic pathologies that interfere with the tasks performance; * older adults who have diabetic foot, lower limb fracture less than 6 weeks, or other related conditions; * older adults who have unstable cardiovascular disease, liver or renal function failure; * older adults who have a body mass index greater than or equal to 30 kg/m2; * older adults who vestibular and/or audition or vision impairments non corrected that influence the performance of tasks; * older adults who presence of symptoms at the time of evaluation that influences the participant performance of tasks.

Keywords: aged older adults aging disability disability evaluation biomechanical phenomena biomechanical analysis kinematics kinetics
effects of multiple concussions in retired nhl players

Conditions: Cognitive Deficits; Proprioceptive Disorders

Summary: to investigate long term affects of multiple concussions on the cognition, balance, proprioception, and biomarkers in retired national hockey league players

this research study will collect data for each subject in one single visit. during the visit the subject will be asked to consent to the study which is estimated to take approximately 10 minutes. a medical history will be obtained, taking approximately 15 minutes. blood, urine, and cheek swabs will be collected for approximately 15 minutes. the phq-9, becks depression inventory, connors adult adhd rating scale (caars™), and montreal cognitive assessment (moca) will be administered, these assessments combined are estimated to take 50 minutes. lastly, patients will be asked to complete a sensory organization test (sot) which takes approximately 15 minutes. there are only licensed health professionals working on this project that will respect your privacy and conduct this trial following all hippa and clinical research guidelines.

Eligibility criteria:
inclusion criteria: * retired professional nhl player * history or reported concussion and concussion like symptoms exclusion criteria: * any neurological condition * non sport related head trauma

Keywords: nhl concussion biomarkers
clinical trial of remote preconditioning in patients undergoing cervical decompression surgery

Conditions: Cervical Compression Myelopathy; Ischemia; Reperfusion Injury; Spinal Cord Injury

Summary: the purpose of this study is to assess whether a large clinical trial testing the effect of ripc on neurologic outcome in patients undergoing elective cervical decompression surge is warranted.

spinal cord ischemia-reperfusion injury commonly contribute to perioperative morbidity and mortality after elective cervical decompression surgery.remote ischemic preconditioning(ripc)is a phenomenon whereby brief periods of ischemia followed by reperfusion in one organ provide system protection from prolonged ischemia.the hypothesis of this protocol is that limb ischemic preconditioning could reduces spinal cord ischemia-reperfusion injury induced by elective cervical decompression surgery.serum s-100b and nse concentration will be measured before and after induction ,and at 6 hours,1,3,5 and 7days after surgery.joa scores in all the cases will be evaluated before operation and at 7days ,1,3,6 month after surgery.

Eligibility criteria:
inclusion criteria: * patients with clinical and radiological signs of cervical compression myelopathy(ccm) * age 30-75 * stage 1-2 exclusion criteria: * age\>75 * history of heart,hepatic,renal or pulmonary disease. * history of peripheral vascular disease affecting the upper limbs.

Keywords: remote ischemic preconditioning cervical compression myelopathy spinal cord neuron-specific enolase s-100b
determination of genetic polymorphisms in chronic chagas cardiomyopathy

Conditions: Chagas Disease

Summary: the purpose of this study is to analyze the influence of polymorphisms of the genes cldn-1 (claudina-1), lgals3 (lectin galactoside-binding soluble 3), socs3 (suppressor of cytokine signaling 3), il-28b (interleukin-28b), ccl5 (chemokine c-c ligand 5) in the determination of clinical forms and in the percentage of cardiac fibrosis in patients with chagas disease.

the chagas disease, in its chronic phase, can lead to the development of cardiac arrhythmias and dilated cardiomyopathy, which can evolve to heart failure, causing great morbidity and reduction on patient's quality of life. some patients stay asymptomatic while others develop the cardiac form of the disease (chronic chagasic cardiomyopathy), or other forms, like the digestive (megacolon and megaesophagus) and the mixed form (cardiac and digestive). the objective of this study is to analyze the association between single nucleotide polymorphisms with the clinical forms and the amount of cardiac fibrosis in patients with chagas disease. the polymorphisms will be analyzed by real time pcr (polymerase chain reaction). the genes whose polymorphisms will be analyzed are: galectin-3, socs-3, il-28b, cldn-1 and ccl5. the patients shall be accompanied in the specialized outpatient clinics for chagas disease - center of biotechnology and cell therapy. they will be submitted to collection of blood samples for biochemical analysis and cardiac magnetic resonance imaging.

Eligibility criteria:
inclusion criteria: * chagas disease diagnosis confirmed by 2 different serologies * diagnosis of chagas disease in both forms: indeterminate and cardiac ones, with and without ventricular dysfunction exclusion criteria: * significant aortic stenosis * mitral stenosis with a valve area inferior than 1,5 cm2 * superior or moderated aortic and/or mitral regurgitation * chronic use of immunosuppressive agents * dialysis treatment of terminal renal failure * fever on the last 48 hours or evidence of systemic infection in activity * current abusive use of alcohol or illicit drugs * any other comorbidities that impact patient's survival within the next 2 years * liver disease in activity * continuous use of steroids as treatment for chronic obstructive pulmonary disease * hematologic, neoplastic or bone diseases * homeostasis disturbances * inflammatory diseases or chronic infectious diseases

Keywords: chagas disease polymorphisms biomarkers
treatment of macular edema caused by leber's miliary aneurysms using intravitreal aflibercept and peripheral laser photocoagulation

Conditions: Macular Edema Caused by Leber's Miliary Aneurysms

Summary: this study evaluates the effectiveness of intravitreal aflibercept (iva) injection therapy, combined with peripheral laser photocoagulation, in the treatment of macular edema caused by leber's miliary aneurysm. we believe that our study makes a significant contribution to the literature because to our knowledge, it is the first to report cases, in which iva injection therapy was used to treat this condition.


Eligibility criteria:
inclusion criteria: * fa revealed many aneurysms with leakage in the temporal mid-peripheral retina and near the macula. optical coherence tomography (oct) showed moderate to marked cystoid macular edema and subretinal fluid. there were no abnormal findings in the cornea, anterior chamber, or lens. no particular lesions were found in the opposite eye of each subject. based on these findings, the patients were diagnosed with leber's miliary aneurysm. exclusion criteria: -