Kornimate/medical-research-clean huggingface dataset:
pfx closure system in subjects with cryptogenic stroke, tia, migraine or decompression illness

Conditions: PFO; Stroke; Transient Ischemic Attack; Migraine; Decompression Illness

Summary: the primary object of this study is to demonstrate the continued safety and performance of the pfx closure system when utilized for patients with pfos suffering from cryptogenic stroke, transient ischemic attack, migraine or decompression illness.


Eligibility criteria:
inclusion criteria: * age 18 to 65 years old * pfo with one or more of: * cryptogenic stroke, * tia or embolism, * history of severe migraine headaches, or * history of severe decompression illness. exclusion criteria: * in appropriate anatomy (vascular or cardiac) or inappropriate medical condition for pfo closure and study medications.

Keywords: pfo stroke transient ischemic attack migraine decompression illness
angiotensin ii in general anesthesia

Conditions: Hypertension

Summary: hypotension in adult patients undergoing general anesthesia is common. this can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. this may be worse in patients with underlying essential hypertension and worse in patients taking angiotensin converting enzyme inhibitors (ace) and angiotensin receptor blockers (arbs). intravenous (iv) administration of ang ii may be an effective treatment of hypotension in this patient population.

hypotension in adult patients undergoing general anesthesia is common. many of the body's normal mechanisms to maintain adequate blood pressure in the non-anesthetized state are significantly altered by anesthetic agents, which may lead to hypotension. this can lead to hypoperfusion of vital organs, organ damage, and states of increased metabolic duress. in response to this it has become standard of care to attempt to maintain blood pressure levels within 20% of baseline in most patients under anesthesia. maintaining the baseline blood pressure is important as patients may have pathology such as coronary artery disease, carotid stenosis, and renal artery stenosis, and hypotension may compromise the perfusion of these organs. vasodilation also plays a key role in hypotension due to general anesthesia. therefore, the intravenous (iv) administration of ang ii may be an effective treatment of hypotension in this patient population.the objective of this study is to determine the infusion rate of ang ii that is necessary to return systolic blood pressure (sbp) to within 5% of baseline or greater in patients with essential hypertension taking ace inhibitors, arbs, or different classes of antihypertensive agents and further to determine the plasma levels of different raas components

Eligibility criteria:
inclusion criteria: * diagnosis of hypertension and treatment with at least one medication including an ace inhibitor, arb, and other agents for greater than 2 months * patients undergoing general anesthesia exclusion criteria: * bmi \> 40 * history of deep venous thrombosis / thromboembolic disease * history of stroke, * baseline sbp of ≥ 160 mmhg, * history of myocardial infarction or cardiac stents * difficult airway * asthma * congestive heart failure * chronic obstructive pulmonary disease * pregnant patients

Keywords: angiotensin ii angiotensin converting enzyme inhibitors angiotensin receptor blockers anesthesia-mediated hypotension
centera pmcf: post-market follow-up of the centera transcatheter heart valve system

Conditions: Aortic Valve Stenosis

Summary: this study will monitor device performance and safety of the edwards centera transcatheter heart valve (thv) system in patients with severe, symptomatic aortic valve stenosis who are indicated for aortic valve replacement.

a prospective, international, single arm, multi-center post market clinical follow-up study.

Eligibility criteria:
inclusion criteria: * severe native valve calcific aortic stenosis * judged by the heart team to be at high or greater risk for open surgical therapy (i.e. predicted risk of surgical mortality greater than or equal to 8% at 30 days, based on the society of thoracic surgeons (sts) risk score and other clinical co-morbidities unmeasured by the risk calculator). exclusion criteria: * known hypersensitivity to nitinol (nickel or titanium) * evidence of intracardiac mass, thrombus, vegetation, active infection or endocarditis * inability to tolerate anticoagulation/antiplatelet therapy

Keywords: centera thv transcatheter heart valve
conventional total hip arthroplasty vs mako robotic-arm assisted total hip arthroplasty

Conditions: Osteoarthritis, Hip; Osteoarthritis; Surgery

Summary: the overall aim of this single-centre, prospective randomised controlled trial is to compare clinical, functional, and radiological outcomes in co tha versus mako tha. patients undergoing mako tha will form the investigation group and those undergoing co tha will form the control group.


Eligibility criteria:
inclusion criteria: * patient has hip osteoarthritis requiring primary tha * patient and surgeon are in agreement that tha is the most appropriate treatment * patient is fit for surgical intervention following review by surgeon and anaesthetist * patient age: patients 18-80 years of age inclusive * gender: male and female * patient must be capable of giving informed consent and agree to comply with the postoperative review program * patient must be a permanent resident in an area accessible to the study site * patient must have sufficient postoperative mobility to attend follow-up clinics and allow for radiographs to be taken exclusion criteria: * patient is not suitable for primary tha e.g. patient requires revision surgery for previously failed tha * patient is not medically fit for surgical intervention * patients under the age of 18 or over 80 years of age * patient is immobile or has another neurological condition affecting musculoskeletal function * patient is already enrolled on another concurrent clinical trial * patient is unable or unwilling to sign the informed consent form specific to this study * patient lacks capacity to give informed consent * patient is unable to attend the follow-up programme * patient is non-resident in local area or expected to leave the catchment area postoperatively

Keywords: total hip arthroplasty total hip replacement implant position computerised tomography makoplasty robotic surgery
new markers of cardiac surgery related acute kidney injury.

Conditions: Acute Kidney Injury; Cardiac Disease

Summary: cardiac surgery related acute kidney injury (cs-aki) is a clinical problem associated with a cardiopulmonary bypass used during cardiac surgery procedures. in this study the investigators will assess the biochemical markers of acute kidney injury such as ischemia modified albumin (ima) or urinary excreted of brush-border enzymes of the proximal renal tubules perioperatively. there has been no official recommendations toward routine use of analysed biomarkers.

cardiac surgery related acute kidney injury (cs-aki) is an important clinical problem. kidney injury occurs following a cardiopulmonary bypass used during cardiac surgery procedures. the pathomechanisms of acute kidney injury (aki) is complex and multifactorial. it may involve few injury pathways: ischemia and reperfusion, endogenous toxins, inflammation, metabolic factors and oxidative stress. biochemical markers of acute kidney injury such as ischemia modified albumin (ima) or urinary excreted of brush-border enzymes of the proximal renal tubules analysed perioperatively will be assessed in this study. there has been no official recommendations toward routine use of analysed biomarkers.

Eligibility criteria:
inclusion criteria: * a planned operation of coronary artery bypass grafting with the use of cardiopulmonary bypass exclusion criteria: * emergency operations or re-operations; * a known pathology of the urinary tract or renal failure; * chronic use of the following medications: iron, non-steroidal anti-inflammatory drugs (nsaids), immunosuppression, or steroids in the preoperative period; * polycythemia, porphyria or pathological hemoglobin species in anamnesis; * preoperative signs of hepatic failure; * active autoimmune or neoplastic diseases, active infection; * anticipated significant bleeding (anti-platelet agents), suggesting the use of blood-derived products during the operation and afterward * acute myocardial infarction after operation

Keywords: acute kidney injury, cardiopulmonary bypass brush-border enzymes of the proximal renal tubules ischemia modified albumin
prophylactic mesh reinforcement for stoma closure

Conditions: Incisional Hernia; Surgical Site Infection; Postoperative Pain

Summary: n the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing surgical site incisional hernia (ssih),incidence of surgical site infection , post-operative pain and hospital stay

intestinal stomas are used to divert intestinal content as a treatment option. faecal flow is diverted from the site of the pathology by bringing the end or a loop of bowel through the anterior abdominal wall; any segments of the colon can be used, as well as the distal part of the ileum. a stoma may be temporary or permanent according to the condition. temporary stomas are usually followed by elective stoma closure 6-8 weeks after. though considered a relative safe procedure, studies reported high morbidity rates following stoma closure with different complications. incisional hernia following stoma closure occurs in up to 30% of patients. incisional hernia affects quality of life, in regards to pain, physical function, ability to work, and cosmoses. other serious complications due to bowel obstruction with incarceration or strangulation can occur which may necessitate reoperation. mesh-reinforced stoma closure shown to decrease the incidence of surgical site incisional hernia (ssih) with low complications risk. though there is a debate about its efficacy due to lake of data ,and doubt to use a mesh in contaminated wounds due to fear of wounds complications which may necessitate mesh extraction or longer hospital stay make it hard for many surgeons to use mesh-reinforced stoma closure. in the current work we are aiming to compare between the mesh-reinforced stoma closure and the anatomical closure in terms of the risk of developing (ssih),incidence of surgical site infection ,post-operative pain and hospital stay

Eligibility criteria:
inclusion criteria: * patients who are fit for aesthesia. * patients with temporary double barrelled and simple loop ostomy * patients older than 16 years old exclusion criteria: * patients with end ostomy * infected stomas
evaluating the efficacy of a mind-body intervention in overcoming opioid addiction

Conditions: Opioid Use; Opioid-use Disorder; Substance Use Disorders

Summary: this study demonstrates the feasibility, acceptability of sky program as an adjuvant therapy for american population suffering with oud through a pilot program in columbus, ohio. the aim of this study is to evaluate the sky program as an adjuvant therapy to treat opioid addiction.

this research proposal aims to test the feasibility, acceptability and efficacy of sky (sudarshan kriya yoga) program, a mind-body intervention, as an adjuvant therapy for people suffering with opioid use disorder (oud), in columbus, ohio. previous research carried out in india in 2015, has demonstrated that sky significantly improved the quality of life among people with oud, however, the suitability, acceptability of sky program has not been tested among american population. sky differs from mindfulness and other meditation processes in that, it is a more physiological, rather than cognitive process. it involves controlled breathing techniques that can be easily mastered, and do not require mental effort. the investigator's goals are to a) demonstrate the feasibility, acceptability and efficacy of sky program as an adjuvant therapy for american population suffering with oud. studies will be carried out in oud subjects at mary haven clinic in columbus. the efficacy of sky will be measured using psychometric questionnaires. feasibility and acceptability will be measured by attendance and attrition.

Eligibility criteria:
inclusion criteria: * the proposed participants are currently residents of mary haven * are currently undergoing addiction treatment which may include medication assisted treatment as well as counseling. * the intervention is designed for adults, therefore, only individuals 18 and above will be included in the study. exclusion criteria: * pregnant women who are beyond their first trimester are excluded from the study as the program requires breathing techniques that are not recommended for pregnant women. * also, patients diagnosed with schizophrenia and bipolar disorder will also be excluded from the study, as sky program is not suitable for people with these conditions.
cognitive behavioral therapy for the treatment of seasonal affective disorder (sad)

Conditions: Seasonal Affective Disorder; Depression

Summary: this study will assess the effectiveness of cognitive behavioral therapy (cbt) in treating seasonal affective disorder (sad), commonly called the "winter blues."

sad is a condition in which people experience depression as a result of seasonal variations in sunlight. although light therapy is a common treatment for sad, a large proportion of people with sad are resistant to this treatment. cbt is effective for nonseasonal depressive disorders, but its use for sad has not been thoroughly explored. this study will determine whether cbt, alone and combined with light therapy, is as effective as light therapy alone in reducing sad symptoms. participants in this study will be randomly assigned to light therapy, cbt, a combination of light therapy and cbt, or a control group (no therapy) for 6 weeks. cbt will be conducted twice a week; light therapy will be conducted twice a day. assessments will be made before, during, and after the study treatment. depression scales, questionnaires, and behavioral tasks will be used to assess the depressive symptoms of participants. a 6-month and 1-year follow-up visit will also be conducted. during the follow-up visits, participants will be interviewed and will complete a questionnaire and a survey.

Eligibility criteria:
inclusion criteria: * diagnosis of seasonal affective disorder (sad) * willing and able to participate in the study procedures exclusion criteria: * major psychological diagnoses other than sad * current psychological or psychiatric treatment

Keywords: phototherapy
continuous saphenous nerve block for total knee arthroplasty

Conditions: Pain, Postoperative

Summary: our study will compare the use of continuous saphenous nerve block performed at the adductor canal in addition to local infiltration analgesia (lia) versus a sham block in addition to lia for total knee replacement. the investigators hypothesize that the saphenous nerve block performed at the level of the adductor canal in addition to lia provides better pain relief than the lia alone without significantly compromising muscle strength and physiotherapy, enabling patients to mobilize early with reduced opioid consumption and les side effects. the investigators will enroll a total of 40 patients (20 patients will receive continuous saphenous nerve block in addition to lia and 20 will receive the sham block and lia). until discharge, the investigators will record patients' pain scores, opioid consumption, side effects and physical therapy progress. if our study proves that the continuous saphenous nerve block in addition to lia can effectively reduce postoperative pain scores to an acceptable level with better physical therapy progress and less opioid consumption, it could be seen as a more attractive alternative to lia alone or other traditionally used methods of postoperative pain control that compromises muscle strength and physiotherapy.


Eligibility criteria:
inclusion criteria: * asa i-iii * age: 40-75 * unilateral tka * use of spinal anesthesia exclusion criteria: * allergy to any of the study medications * intolerance to morphine * contraindication to a spinal anesthetic * intraoperative use of any volatile anesthetic * chronic opioid use * asa class 4-5 * rheumatoid arthritis or diabetes mellitus with neuropathy * liver or kidney failure * bmi above 40 * severe copd
goalie: intramuscular vs. enteral penicillin prophylaxis to prevent progression of latent rhd trial

Conditions: Rheumatic Heart Disease

Summary: the goal of this clinical trial is to determine if twice daily oral penicillin prophylaxis is non-inferior to monthly im penicillin prophylaxis in preventing latent rheumatic heart disease progression in children between the ages of 5-17 years. the main objective is to compare the proportion of children aged 5-17 years with latent rhd receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive im penicillin prophylaxis.

goalis is a randomized controlled trial developed to provide high quality contemporary evidence on the efficacy of oral penicillin as rhd prophylaxis. aim 1: to compare the proportion of children aged 5-17 years with latent rhd receiving oral penicillin prophylaxis who progress to worse valvular disease at 2-years compared to children who receive im penicillin prophylaxis. aim 2: to evaluate the economic equivalence and cost-effectiveness of oral penicillin compared to im penicillin, after echocardiographic screening for latent rhd detection. aim 3: compare patient-reported outcomes (treatment acceptance, treatment satisfaction, and health-related quality of life) between children receiving oral and im penicillin prophylaxis.

Eligibility criteria:
inclusion criteria: * has a new diagnosis of latent rhd detected through primary or secondary school echocardiographic screening. * has agreed to participate in the study via the study's informed consent/assent process. operational definition of latent rhd borderline rhd or mild definite rhd (to include no more than mild regurgitation at the mitral or aortic valve, normal mean mitral and aortic valve gradients, normal bi-ventricular function) according to the 2012 whf consensus criteria. exclusion criteria: * known history of arf or rhd * newly diagnosed rhd by echo screening considered to be "missed clinical rhd" as compared to true latent rhd including: \> mild pathological valvular regurgitation at the mitral valve or aortic valve, mitral stenosis (mean mv gradient ≥ 4mmhg) (definite b61), aortic stenosis (mean av gradient ≥ 20mmhg) * structural or functional cardiac defects, other than those consistent with rhd, that were known prior to or detected through echo screening (except patent foramen ovale, small atrial septal defect, small ventricular septal defect, small patent ductus arteriosus) * self-report of prior allergic reaction to penicillin * any known conditions predisposing to thrombocytopenia or hypercoagulability, or other contraindications to intramuscular injection * any known co-morbid conditions (ex. hiv, renal deficiencies, severe malnutrition) that have resulted in prescription of regular antibiotic prophylaxis)
stereotactic body radiotherapy (sbrt) for localized prostate cancer

Conditions: Prostate Cancer

Summary: this is a trial of 5 fraction sbrt combined with androgen deprivation therapy for patients with localized high-risk or unfavorable intermediate risk prostate cancer


Eligibility criteria:
inclusion criteria: * histologically confirmed primary non-metastatic adenocarcinoma of the prostate * high-risk or unfavorable intermediate-risk as defined below: high-risk localized prostate cancer, as defined by any one of the following factors: pre-biopsy or any psa ≥20 prior to enrollment, or gleason score 8 or higher on any biopsy core, or ct3a or higher. unfavorable intermediate risk localized prostate cancer, as defined as any of the following factors: gleason score of 4+3 or higher on any biopsy core, or gleason score 3+4 and \>50% biopsy cores positive, or the presence of any two of the following: psa\>10, ct2b-c, gleason score 3+4 in any core * no pelvic nodal metastases (based on ct or mri findings) * no distant metastases, based upon: ct scan or mri of the pelvis within 120 days prior to registration, bone scan within 120 days prior to registration; if the bone scan is suspicious, a plain x-ray and/or mri must be obtained to rule out metastasis * age ≥ 18 * kps ≥ 70 (or ecog 0-2) * ability to understand, and willingness to sign, the written informed consent exclusion criteria: * patients with low-risk or favorable intermediate-risk prostate cancer do not meet inclusion criteria (these patients would be eligible for sbrt off-trial as a standard of care option) * patients with any evidence of distant metastases * hormonal therapy (lhrh agonist or oral anti-androgen) exceeding 7 months prior to registration * prior cryosurgery, hifu or brachytherapy of the prostate * prior pelvic radiotherapy * history of crohn's disease or ulcerative colitis
fibromyalgia and sexual functıonal dısorder and sexual therapy

Conditions: Fibromyalgia; Sexual Dysfunction

Summary: investigators aim to re-evaluate the findings of fibromyalgia in patients whose fsfi scores return to normal levels after sexual therapy, by identifying patients with sexual dysfunction according to the fsfi scale applied in patients investigators followed up with a diagnosis of fibromyalgia, and when investigators consulted with obstetricians.

apart from routine fibromyalgia treatments, investigators think that fibromyalgia patients should be evaluated in detail in terms of sexual dysfunction, and better results will be obtained by adding sexual therapy to the treatment in patients with fsfi score below 26.55. in the current literature review, investigators have seen that there is no study on the evaluation of fibromyalgia before and after sexual therapy. investigators think that our study will be a pioneer in terms of showing the importance of the multidisciplinary approach in the treatment of fibromyalgia. investigators foresee that sexuality is still a subject that is avoided to be talked about due to the cultural infrastructure of developing countries, and that fibromyalgia will actually decrease with the regulation of sexual life. investigators believe that more comprehensive studies with this perspective will develop a multidisciplinary approach in fibromyalgia.

Eligibility criteria:
inclusion criteria: * follow-up with a diagnosis of fibromyalgia * reproductive age (15-49 years) * women with sexual dysfunction (fsfi score \< 26.55) exclusion criteria: * women wıth ibromyalgıa wıthout sexual dysfunction * women wıth a score greater 26.55 wıthout therapy

Keywords: fibromyalgia patients quality of life sexual desire fsfi scala
akin criteria: acute kidney injury after on-pump coronary artery bypass graft (cabg)

Conditions: Kidney Failure

Summary: the purpose of this study is evaluate clinical outcomes and 30-day mortality after on-pump cabg.

eight hundred and seventeen patients was enrolled in this series and divided into to groups: group aki (-) - patients without acute kidney injury after on-pump cabg. group aki (+) - patients with acute kidney injury after on-pump cabg. aki was defined as an absolute increase in serum creatinine (scr) of more than or equal to 0.3 mg/dl (≥ 26.4 μmol/l) or a percentage increase in scr of more than or equal to 50% (1.5-fold from baseline). the change in scr concentration was defined as the difference between immediate postoperative concentration and the highest concentration during the stay in icu. clinical outcomes and 30-day mortality was evaluate in this patients.

Eligibility criteria:
inclusion criteria: * patients underwent on-pump coronary artery bypass grafting * patients with at least two serum creatinine values within 48 hours. exclusion criteria: * patients with end-stage kidney disease requiring renal replacement therapy.

Keywords: acute kidney failure clinical outcomes on-pump coronary artery bypass grafting morbidity mortality