Kornimate/medical-research-clean huggingface dataset:
dual antiplatelet therapy versus oral anticoagulation for a short time to prevent cerebral embolism after tavi

Conditions: Aortic Valve Stenosis; Stroke

Summary: the purpose of this study is to determine the incidence of major vascular events (ischemic or haemorrhagics) at the third month after initiation of the antithrombotic treatment (oral anticoagulation or dual antiplatelet therapy) in both arms followed tavi.

transcatheter aortic valve implantation (tavi) procedure using any of their vascular access is an option with proven benefit definitively for treatment of severe symptomatic aortic stenosis in patients considered unsuitable for conventional open heart surgery. by avoiding the hemodynamic effects, cardiovascular and cerebral microembolic load of cardiopulmonary bypass circulation, it is assumed that the tavi procedure is beneficial despite the risk of neurological complications. currently antithrombotic therapy after the procedure is not standardized. international treatment guidelines recommends that post-operative patients with a conventional surgical aortic bioprosthesis maintain oral anticoagulation for 3 months after the procedure, unless otherwise noted for its continuation. whereas some studies have postulated that in patients with aortic bioprostheses, dual antiplatelet therapy is as effective to prevent major cardiac and cerebrovascular events as oral anticoagulation, with a lower incidence of bleeding complications at 3 months of treatment, the investigators formulated the following hypothesis: • there is a lower incidence of major cardiac and cerebrovascular events in patients with dual antiplatelet therapy compared to patients with oral anticoagulation for 3 months after implantation of an aortic bioprosthesis tavi procedure.

Eligibility criteria:
inclusion criteria: 1. adult patients (more than 18 years) with ability to understand and accept the participation in the clinical trial. 2. patients with symptomatic degenerative severe aortic stenosis rejected for conventional surgical aortic valve replacement due to unacceptably high risk and accepted for tavi procedure 3. signed informed consent. 4. patients who are not participating in any other clinical trial or research study. exclusion criteria: 1. patients under oral anticoagulation treatment 2. patients who can not undergo mri study 3. recent stroke \< 14 days prior, revascularized coronary artery disease or life expectancy \< 12 months 4. patients with proven allergy to aspirin, clopidogrel or acenocoumarol 5. patients that after tavi procedure can not undergo a regimen of dual antiplatelet therapy or oral anticoagulation for 3 months due to any new post-tavi medical indication

Keywords: antiplatelet anticoagulation
managing diabetes mindfully study

Conditions: Diabetes Mellitus

Summary: to evaluate the feasibility of conducting a trial of a mindfulness-based stress reduction (mbsr) program for patients with diabetes (dm) on measures of hba1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life; and to estimate the effect of a mbsr program for patients with dm. it is expected that mbsr program participants will evidence a trend toward better clinical outcome measures of hba1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life.

primary objective: evaluate the feasibility of conducting a trial of a mbsr program for patients with diabetes on measures of hba1c, blood pressure, perceived stress, depression, patient self-efficacy and quality of life. feasibility will be assessed via: a) the interest of patients in taking part in an mbsr program; c) the effectiveness of strategies for recruiting patients with diabetes into the study; d) rates of participant compliance with the mbsr; and, e) patient compliance with the program evaluation plan. estimate the effect of a mbsr program for patients with diabetes. it is expected that mbsr program participants will evidence a trend toward better clinical outcome measures of hba1c, blood pressure, and standardized measures of diabetes self-management, perceived stress, depression, self-efficacy, and quality-of-life. secondary objective: to explore the experience of people with diabetes who participate in an mbsr course through the use of semi-structured interviews.

Eligibility criteria:
inclusion criteria: * 18-80 years of age * english speaking * have type 2 diabetes, with 2 hba1c values \>8 in prior 16 months * hba1c value of \>8 within 3 months of intervention start * able to read course materials * mentally intact with no history of mental illness or major depression * reachable by phone (for phone support component) * able to attend weekly classes * willing to provide written informed consent exclusion criteria: * completed formal training in other mind body practices such as meditation, yoga, or tai chi within the prior year or currently have a regular ongoing practice in this area.

Keywords: mindfulness-based stress reduction diabetes management stress reduction diabetes testing
prospective study of classification and activity assessment of psoriatic arthritis based on power doppler (pd) ultrasonography (pdus)

Conditions: Psoriatic Arthritis; Secukinumab; Ultrasonography

Summary: psoriatic arthritis (psa) is a complex inflammatory disease with heterogeneous clinical features, which complicates psoriasis in 30% of patients. psa involves multiple tissues and clinical domains including skins and nails as well as arthritis, spondylitis, enthesitis, and dactylitis. power doppler (pd) ultrasonography (pdus) is a sensitive non-invasive imaging technology used to assess disease activity and treatment response in psa. this is a prospective, observational, open-label study to investigate disease activity, therapeutic response and bone destruction based on ultrasonography findings in patients with psa.


Eligibility criteria:
inclusion criteria: * psa patients as defined by caspar criteria * patients must be able to comply with the visit schedule, treatment plan, laboratory tests and other study procedures * patients must be given informed consent exclusion criteria: * history of other arthritis within the last 12 months * concomitant disease with acute or chronic infectious diseases * pregnancy or laction * poorly tolerated with venipuncture required for blood sampling during the study
does perioperative music prevent sleep disturbances in hospitalized surgical patients

Conditions: Sleep

Summary: sleep disturbances are known to be a prevalent problem in hospitalized, surgical patients, which is of importance since sleep disturbances can lead to a range of negative health outcomes. music interventions have shown potential in improving sleep quality. unfortunately, the studies on the effect of music on sleep in surgical patient populations are still scarce and of low quality. therefore, the aim of this study is to study the effect of music on sleep quality in oncological, gastro-intestinal surgical patients in the form of a randomized controlled trial. participants will be divided in 2 groups, a music group and a control group, where the music group will receive music interventions perioperatively. the researchers will compare both groups to see if there is a difference in sleep quality.


Eligibility criteria:
inclusion criteria: * patients aged 18 years or older * patients undergoing major elective abdominal surgery for malignant disease, including, but not limited to: esophageal, gastric, colorectal, hepatic, pancreatic, gynecological and urological surgical procedures. * sufficient knowledge of the dutch language. * communicable and able to assess the questionnaires * written informed consent acquired from the patient. exclusion criteria: * patients with severe hearing impairment (defined as no or barely verbal communication possible). * the patient is expected to be transferred to another hospital postoperatively. * participation in another study that may possibly intervene with the outcome measures. (e.g. in trial use of sleep medication, interventions regarding sleep quality or quantity or similar procedures) * assessment of primary outcome is not possible. * inability or unwillingness to receive the music intervention. * inability to wear the actigraphy device, or inability to perform actigraphy measurement due to paralysis.
follow-up extension to the family study of binge eating disorder

Conditions: Binge Eating Disorder

Summary: this study involves a 2.5 and 5 year follow-up interview for individuals who participated in the initial family study of binge eating disorder. the study includes individuals with and without eating disorder as well as their first degree relatives. as part of the study, participants will be interviewed about their current psychiatric and medical symptoms, their blood pressure will be measured, and laboratory specimens will be obtained.

previously we completed a family interview study of 150 individuals with binge eating disorder, 150 matched controls, and approximately 888 of their first degree relatives. in follow-up to this, we are interviewing these individuals again at 2.5 and 5 years after their initial interview. during the course of the interview, individuals are asked about their psychiatric and medical history and blood pressure and laboratory specimens are obtained to measure, among other things, fasting lipids and glucose.

Eligibility criteria:
inclusion criteria: * individuals with or without binge eating disorder and their family members who participated in the initial family study of binge eating disorder and agree to be followed up at 2.5 and 5 years. exclusion criteria: * unwilling or unable to participate in the follow-up study.

Keywords: binge eating disorder eating disorder
the pain and anxiety in children with intramuscular injection

Conditions: Intramuscular Myxoma

Summary: this study was planned as a randomized controlled experimental study to determine the effect of distraction cards and stress ball on pain and anxiety in children with intramuscular injection.

pharmacological and non-pharmacological methods are used in the management of pain and anxiety in children. non-pharmacological methods are noninvasive, inexpensive, have no side effects and are independent functions of the nurse.this study was planned as a randomized controlled experimental study to determine the effect of distraction cards and stress ball on pain and anxiety in children with intramuscular injection. the study was conducted between may 2022 and august 2022. it will be done with children aged 3-6 years who come to the emergency unit of the state hospital, who are given intramuscular injection. "descriptive information form", "wong baker faces pain rating scale", "venham anxiety rating picture scale" will be used in data collection.

Eligibility criteria:
inclusion criteria: * 3-6 years old * intramuscular administration of ondansetron hcl active ingredient drug * mentally and physically handicapped * does not have a disease that causes chronic pain * open to communication * fluent in turkish exclusion criteria: * children of parents who did not give written consent * children who do not give verbal consent appropriate to the child's developmental level

Keywords: children pain, acute anxiety
effect of a flexibility program on the extensibility of the hamstrings and the thoracic and lumbar spinal curvatures

Conditions: Spine Injury; Hamstring Injury; Lumbar Hyperlordosis; Kyphosis

Summary: the goal of this clinical trial is to analyse the effect of an intervention program based on hamstring flexibility on the extensibility and curvatures of the spine in dancers. participants will be dance student with ten years of experience that will undergo a program of stretching four times per week during seven weeks, followed by a detraining period, and a retraining period of three weeks. there will be a pre-test, a post-test and two re-tests after the intervention. the results will be compared with a control group of dancers that will not take part in the stretching program.

four measurements were carried out, one before the intervention (pre-test), one after the first stretching programme (post-test), one after a short period of detraining (re-test 1) and the last one at the end of a second period of intervention (re-test 2), analysing the intra-group and inter-group differences for each of the dependent variables. the sample components (n=61) were divided into two groups following a random distribution carried out by an external researcher. the intervention group (ig), which consisted of 31 dancers, underwent the hamstring stretching programme for a first period of 7 weeks and a second period of 3 weeks after a short period of detraining. the intervention consisted of static and dynamic stretching of the hamstring muscles 4 days per week. the control group (cg), composed of 30 dancers, did not perform the stretching programme. both groups attended their practical classes in the conservatory. during the detraining period the dancers of both groups took a break from physical exercise. the variables measured are hamstring extensibility and sagittal spine disposition and pelvic tilt.

Eligibility criteria:
the inclusion criteria were: 1. students enrolled for at least 18 ects credits at the high conservatory of dance; 2. previous experience of 10 years in dance; 3. practice dance at least 4 days a week; (c) not suffer from any chronic pathology or at the time of the study; (d) not practising any other physical exercise apart from dance. exclusion criteria: 1. not attending at least 80% of the practical sessions of the conservatory throughout the programme; 2. being pregnant at the beginning of the study or getting pregnant during the development of the study; 3. having undergone surgery on the spine or hamstring musculature; 4. having suffered a hamstring injuries in the last year or during the study; 5. having structured spinal disorders; 6. having an injury at the time of the assessment that prevents her from taking the measurements; 7. stretching of the hamstring musculature outside the conservatory.

Keywords: flexibility training dancers ballet flexibility testing
minocycline accelerates intracerebral hemorrhage absorption

Conditions: Intracerebral Hemorrhage

Summary: minocycline has been found to reduce cerebral edema secondary to cerebral hemorrhage, promote hematoma absorption, and shorten hematoma absorption time; clinical studies have been conducted to confirm the safety in the treatment, but no significant hematoma absorption effect was seen with short duration of drug use. therefore, the investigators propose to conduct a multicenter randomized controlled clinical trial to determine its accelerating effect on hematoma absorption.

there is a significant increase in the incidence of spontaneous intracerebral hemorrhage, combined with a high mortality rate. surgical treatment is mainly used to remove intracerebral hematoma with a supratentorial volume greater than 20ml, and most intracerebral hematomas below 20ml are left to absorb on their own, and the absorption time of such hematomas is about 4 to 6 weeks. minocycline is a tetracycline antibiotic routinely used in clinical practice for the treatment of bacterial infection and acne. it has been found that it can not only reduce iron overload after intracerebral hemorrhage and inhibit neuroinflammation, but also reduce secondary cerebral edema. some animal experiments have confirmed that it can promote hematoma absorption through iron chelation and shorten hematoma absorption time; clinical studies have been conducted to confirm the safety in the treatment of intracerebral hemorrhage, but no significant effect has been seen with short duration of drug use. no clinical rct study has been conducted to confirm its accelerating effect on the absorption of adult intracerebral hematoma. therefore, the investigators propose to conduct a multicenter randomized controlled clinical trial to determine its accelerating effect on hematoma absorption, and this study will have important clinical practical value.

Eligibility criteria:
inclusion criteria: * 18-80 years old * spontaneous intracerebral hemorrhage by ct scan * intracerebral hematoma volume is less than 16ml * no surgical treatment of hematoma evacuation exclusion criteria: * allergies to tetracycline antibiotics * pregnancy or suspected pregnancy (pregnancy test will be done on women with fertility potential) * hepatic and/or renal insufficiency * glasgow coma scale of 5 or less * secondary cerebral hemorrhage caused by trauma, arteriovenous malformation, aneurysm, tumor or other reasons * thrombocytopenia (platelet count\ 1.4) * incapable to take care of themselves in past life (score of rankin scale before stroke\>2) * signed dnr (do not resuscitate)

Keywords: minocycline hematoma absorption
a study to assess the feasibility of non-invasive dried blood sampling

Conditions: Muscular Dystrophies

Summary: this is a phase i, open-label, single-dose, 1-period study to compare edg-5506 concentrations measured from venous and capillary blood sampling in healthy adult subjects. edg-5506 is an investigational product designed to selectively modulate a fast skeletal muscle motor protein called myosin that is part of the contraction machinery of the damage-prone muscle fibers.

ten (10) healthy, adult male and female (of non-childbearing potential only) participants will be enrolled in the single-site study. participants will receive a single oral dose of edg-5506 on day 1. serial blood sampling will be collected pre-dose and up to 26 hours post-dose using venous blood sampling by venipuncture and capillary blood sampling by a capillary blood self-sampling device. on day 3, participants will self-collect a capillary blood sample at home. the final on-site visit will be on day 7 when a last blood sample will be collected using venous blood sampling by venipuncture and capillary blood sampling by a capillary blood self-sampling device.

Eligibility criteria:
inclusion criteria: 1. healthy, adult, males or females, aged 19-55 years (inclusive) at the screening visit. 2. females must be of non-childbearing potential. males with female partners must use a medically accepted contraceptive regimen or abstain from sexual intercourse for 90 days after dosing. 3. non-smoker and must not have used any tobacco products within 3 months prior to the screening visit. 4. body weight greater than 50 kg and body mass index (bmi) between 18.0 and 30.0 kg/m2 inclusive at the screening visit. 5. medically healthy with no clinically significant findings for oculofacial and proximal limb strength assessments and swallowing function assessment, medical history, physical examination, laboratory profiles, vital signs, and ecgs. exclusion criteria: 1. history of, or physical examination findings indicating clinically significant endocrine, neurological, gastrointestinal, cardiovascular, hematological, hepatic, immunological, renal, respiratory, or genitourinary abnormalities or diseases that, in the opinion of the pi, would render the subject being unsuitable for the study. 2. female participants with a positive pregnancy test at the screening visit or are lactating. 3. poor venous access and/or cannot tolerate venipuncture. 4. unable to refrain from or anticipates the use of any drugs (including prescription and non-prescription medications, herbal remedies, vitamin supplements, or grapefruit/seville orange containing products) beginning 14 days prior to dosing. any drugs known to be moderate or strong inducers of cyp3a4 enzymes cannot be used within 28 days prior to dosing. 5. participation in any other investigational drug study within 30 days prior to dosing.

Keywords: healthy volunteers
immuno-positron emission tomography study of 89zr-s095012 in patients with advanced solid tumours

Conditions: Advanced Solid Tumor

Summary: the purpose of this study is to assess the whole-body biodistribution and tumour uptake of 89zr-s095012 in participants with solid tumours treated with s095012 (pd-l1x4-1bb bispecific antibody)


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of unresectable, locally advanced or metastatic solid tumour, for which standard treatment options are not available, no longer effective, or not tolerated * at least one measurable target lesion as per recist 1.1 * eastern cooperative oncology group (ecog) performance status of 0 or 1 * royal marsden prognosis score of 0 to 1 (score based on lactate dehydrogenase (ldh) value, albumin value and number of sites of metastasis) * adequate organ function as assessed by laboratory tests (especially adequate hepatic function) * negative test results for cytomegalovirus (cmv), epstein-barr virus (ebv), hepatitis b virus (hbv), and hepatitis c virus (hcv) infection, according to local standards. exclusion criteria: * participants with no available archived material and no tumour lesions amenable to biopsy * participants with primary central nervous system malignancies, with child-pugh class b8 or higher, or c liver cirrhosis * participants with active auto-immune disease or immune-related adverse event currently requiring systemic anti-inflammatory agent (more than 10mg/day prednisone or equivalent) * participants with a history of an opportunistic infection within a year before the administration of first study drug dose are excluded. * participants who received either systemic corticosteroids (\> 10 mg per day of prednisone or equivalent) or other immunosuppressive medication during the 2 months prior to the first dose of the study drug are excluded. * participants with prior history of grade ≥ 3 immune-related pneumonitis, colitis, hepatitis, or myocarditis * participants with a history of progressive multifocal leukoencephalopathy * participants must not have a history of active tuberculosis requiring treatment within 3 years prior to the start of treatment or a suspicion of latent tuberculosis by the investigator.
using positive pressure ventilation for preoxygenation during panendoscopy.

Conditions: ENT Cancer Screening

Summary: the aim of the study is to determine if spontaneous ventilation with positive pressure ventilation (ppv) preoxygenation allows a longer non hypoxemic apnea time during panendoscopy compared to spontaneous breathing preoxygenation. the hypothesis is ppv extends the residual functional capacity of lung so it provides more oxygen during apnea.


Eligibility criteria:
inclusion criteria: * patient going for scheduled panendoscopy under general anesthesia exclusion criteria: * bmi upper to 35 kg/m2 * pregnancy * requirement of jet ventilation * tracheostomy * acute respiratory failure: pneumonia, pulmonary embolism * health insurance careless

Keywords: panendoscopy preoxygenation non invasive ventilation