Kornimate/medical-research-clean huggingface dataset:
the deep phenotype of lamin a/c cardiomyopathy

Conditions: Lamin A/C Gene Mutation; Dilated Cardiomyopathy, Familial

Summary: this study seeks to discover clinically useful tests to improve the diagnosis of a rare and serious heart muscle disease caused by mutations in a gene called 'lamin'. patients born with lamin gene mutations have apparently healthy hearts initially, they begin experiencing symptoms in their twenties or thirties, and by age 45 the majority have undergone a heart transplant, experienced a major cardiac complication, or have died. sudden heart rhythm abnormalities are a major cause of sudden death so earlier diagnosis can save lives by enabling timely treatment or implantation of specialised pacemakers (defibrillators). in clinical practice, diagnosis of lamin heart disease currently relies on the genetic test. very little is known about the detailed imaging features of the hearts of patients with lamin heart disease although advanced echocardiography and cardiac mri now offer the opportunity to study the health of the heart without the need for radiation.

* research participants will undergo resting 12-lead ecg, 24-hour ambulatory ecg, baseline echocardiography, exercise echocardiography, cardiac mri scan. * blood samples will be collected in all participants from both centers for immediate laboratory testing. * blood and urine samples will be collected in all participants and used for metabolomic, proteomic and lipidomic profiling and for targeted metabolite and enzyme analysis. * blood samples will be collected in all participants for future gene code analysis (dna / rna).

Eligibility criteria:
inclusion criteria: * lmna+ cases with pathogenic lmna mutations for lmna+ and heart myocardial samples from the explanted hearts of lmna+ patients who are scheduled to undergo clinically indicated heart transplantation at the papworth hospital nhs trust. * dcmwt cases: patients with heart muscle failure but with wild-type lamin gene. heart myocardial samples from the explanted hearts of dcmwt patients who are scheduled to undergo clinically indicated heart transplantation at the papworth hospital nhs trust. * hv (controls): matched to cases. exclusion criteria: * needle-phobia that would preclude blood-letting * participants unwilling to consent * patients that have a conventional contraindication for cardiac magnetic resonance imaging (mri). * patients that have had a blood transfusion within the last month and patients having haemodialysis will be excluded.

Keywords: dilated cardiomyopathy lamin a/c cardiomyopathy heart failure
bms-986325 in healthy participants and participants with primary sjögren's syndrome

Conditions: Healthy Participants; Primary Sjögren's Syndrome

Summary: the purpose of this study is to evaluate the safety, tolerability, drug levels, and drug effects of bms-986325 in healthy participants and participants with primary sjögren's syndrome. the results will guide the future clinical development with bms-986325.


Eligibility criteria:
inclusion criteria: healthy participants (part a and part b) * healthy male and female participants as determined by no clinically significant deviation from normal in medical history, physical examination (pe), electrocardiograms (ecgs), and clinical laboratory determinations * males and females, ages 18, or local age of majority, to 50 years, inclusive at screening * body mass index (bmi):18.0 to 30.0 kg/m2, weight: ≥ 50 kg at screening * must be fully vaccinated against sars-cov-2 participants with sjögren's syndrome (part c) * sjögren's syndrome in the absence of another immune-mediated disease or rheumatologic condition based on the 2016 american college of rheumatology-european league against rheumatism (eular) classification criteria for primary sjögren's syndrome (pss). historical diagnosis as pss documented in medical records, using the 2016 acr/eular criteria, is also acceptable * seropositive for anti-sjögren's syndrome antigen a antibody (anti-ssa). previous anti-ssa are also acceptable, and results should be documented in the case report form (crf) as past medical history * males and females, ages 18, or local age of majority, to 75 years, inclusive at screening * body mass index (bmi): 18.0 to 35.0 kg/m2; weight ≥ 50 kg at screening * must be fully vaccinated against sars-cov-2 according to local regulations exclusion criteria: healthy participants (part a and part b) - any significant acute or chronic medical illness healthy participants (part a and part b) and participants with primary sjögren's syndrome (pss) (part c) - any major surgery within 4 weeks prior to study drug administration, or any surgery planned during the course of the study other protocol-defined inclusion/exclusion criteria apply

Keywords: primary sjögren's syndrome healthy participants bms-986325
ed lung protective ventilation to reduce complications

Conditions: Mechanical Ventilation; Ventilator-associated Conditions; ARDS

Summary: early mechanical ventilation, if delivered with injurious settings, can lead to pulmonary complications, such as acute respiratory distress syndrome (ards). mechanical ventilation in the emergency department (ed) has been studied infrequently when compared to the intensive care unit; however, data suggests that ed-based mechanical ventilation has significant room for improvement and may also be a causative factor in ards incidence.

this is a before-after study examining the impact of implementing lung protective ventilation in the emergency department.

Eligibility criteria:
inclusion criteria: * mechanically ventilated via an endotracheal tube in the ed exclusion criteria: * death in the ed, * death or discontinuation of ventilation within 24 hours, * chronic mechanical ventilation, * ards while in the ed * transfer to another hospital.
a prospective study to evaluate the itotal knee and ipoly xe tibial inserts

Conditions: Knee Osteoarthritis

Summary: this study is designed to evaluate the clinical outcomes of subjects who have recently undergone surgery with the itotal® cruciate retaining (cr) total knee replacement system (krs) who have also had ipoly xe tibial inserts implanted.

the study is prospective and single-center. subjects will be implanted with an itotal® cr knee replacement system in conjunction with an ipoly xe insert. the study will include a minimum of 50 subjects and a maximum of 60 subjects at a single center. the study site will be located in germany. the study subjects will be followed for 10 years post implant.

Eligibility criteria:
inclusion criteria: 1. clinical condition included in the approved indications for use for the itotal® cr 2. osteoarthritis, as confirmed by the investigator's assessment of disease status at screening visit that warrants a tkr procedure. disease status is assessed by clinical and radiographic assessment. 3. willingness to participate in the clinical study, to give informed consent, and to attend all follow-up visits 4. \> 18 years of age exclusion criteria: 1. simultaneous bilateral procedure required 2. bmi \> 40 3. active malignancy (defined as a history of any invasive malignancy - except non-melanoma skin cancer), unless patient has been treated with curative intent and there have been no clinical signs or symptoms of the malignancy for at least 5 years 4. poorly controlled diabetes 5. neuromuscular conditions which prevent patient from participating in study activities 6. active local or systemic infection 7. immunocompromised 8. fibromyalgia or other general body pain related condition 9. rheumatoid arthritis or other forms of inflammatory joint disease 10. loss of bone or musculature, osteonecrosis, neuromuscular or vascular compromise in the area of the joint to be operated on, to an extent that the procedure is unjustified 11. diagnosed with or receiving treatment for osteoporosis 12. other physical disability affecting the hips, spine, or contralateral knee 13. severe instability due to advanced loss of osteochondral structure 14. prior arthroplasty of the affected knee, including high tibial osteotomy (hto) 15. compromised pcl or collateral ligament 16. severe fixed valgus or varus deformity of \>15º 17. extensor lag \> 15º 18. fixed flexion contracture ≥ 15º 19. unwilling or unable to comply with study requirements 20. participation in another clinical study which would confound results 21. allergy to any of the implant materials

Keywords: knee implant osteoarthritis patient-specific knee osteoarthritis
intravitreal aflibercept for therapy of patients with pseudoxanthoma elasticum (pxe)

Conditions: Pseudoxanthoma Elasticum

Summary: the purpose of this study is to determine whether aflibercept (eylea) is effective in the treatment of choroidal neovascularization and fibrovascular proliferation in patients with pseudoxanthoma elasticum (pxe) in terms of preservation or improvement of visual acuity.


Eligibility criteria:
inclusion criteria: * diagnosis of pxe by moleculargenetic diagnosis and/or skin biopsy * diagnosed cnv or fvp * age 18-65 years * voluntary participation in this study as proven by written informed consent * ability to follow study instructions and likely to attend and complete all required visits * best corrected visual acuity between 20/400 and 20/20 at treated eye * male and female patients with childbearing potential must use an approved contraceptive method (pearl index \< 1) before and during the trial * pre-menopausal female patients with childbearing potential: a negative pregnancy test must be obtained exclusion criteria: * subject is unable to understand the nature, scope, significance and consequences of this clinical trial * patients with known allergy or hypersensitivity to eylea or preparations with similar chemical structure * treatment in another clinical trial with therapeutic intervention or use of any other investigational medicinal product (imp) during the trial of within 30 days before enrolment * known or persistent abuse of medication, drugs or alcohol * women who are pregnant or breast feeding * lack of eligibility at discretion of the investigator * ocular operations within a month prior to enrolment * non-controlled glaucoma * active intraocular inflammation or inflammation of ocular adnexa * other diseases resulting in distinct visual constraint * distinct opacification of optical media * distinct subretinal fibrosis and /or atrophy that prevents a relevant treatment effect by aflibercept at discretion of investigator * serious cardiovascular problems or stroke within 6 months before enrolment * simultaneous use of other vascular endothelial growth factor (vegf)-inhibiting medication (systemic or ocular) within a month prior to enrolment

Keywords: choroidal neovascularization angioid streaks pseudoxanthoma elasticum vascular endothelial growth factor aflibercept
glycan analysis in diagnosing cancer in women with ovarian epithelial cancer and in healthy female participants

Conditions: Ovarian Cancer

Summary: rationale: new diagnostic procedures, such as glycan analysis, may be effective in finding ovarian epithelial cancer. purpose: this clinical trial is studying how well glycan analysis works in diagnosing cancer in women with ovarian epithelial cancer and in healthy female participants.

objectives: primary * evaluate the accuracy of glycan analysis to distinguish between normal healthy control female subjects and those with ovarian epithelial cancer. secondary * compare the new assay to the standard ca 125 for diagnostic accuracy. outline: * ovarian cancer patients: blood samples are obtained periodically for up to 2 years. patients undergoing surgery have blood samples drawn before and after surgery. medical charts are reviewed periodically for up to 3 years. * healthy volunteers: one blood sample is obtained. volunteers also complete a 1-page questionnaire. projected accrual: a total of 300 healthy female participants and 400 patients will be accrued for this study.

Eligibility criteria:
inclusion criteria: * able to understand consent document for participation in the study * not pregnant * negative pregnancy test participants must meet 1 of the following criteria: * patients scheduled for ovarian surgery for an ovarian mass * healthy female volunteers with no active cancer or history of cancer

Keywords: ovarian germ cell tumor ovarian epithelial cancer
the effect of stress ball on anxiety, comfort and non stress test parameters of pregnant women during non stress testing

Conditions: Anxiety; Comfort

Summary: non-stress testing (nst) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. nst is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. high levels of anxiety during the common nst procedure can negatively affect the test result and increase the rate of nonreactive nst, potentially leading to misinterpretation. therefore, midwifery/nursing interventions to make the pregnant woman comfortable during the procedure and to reduce anxiety and stress are important.

non-stress testing (nst) is used to assess fetal wellbeing and to detect and intervene early in fetuses at risk. nst is an easy to administer, noninvasive, prenatal assessment method used from 32 weeks of gestation to term. high levels of anxiety during the common nst procedure can negatively affect the test result and increase the rate of non-reactive nst, potentially leading to misinterpretation. therefore, midwifery/nursing interventions to make the pregnant woman comfortable during the procedure and to reduce anxiety and stress are important. stress ball is one of the nonpharmacological methods in the management of pain, stress and anxiety based on the logic of drawing the attention of the person to a different side and is an application for the sense of touch. in the obstetric field, there have been studies evaluating the effects of stress ball application on labor and vascular pain of pregnant women, but there is no study evaluating anxiety, comfort and nst parameters during nst.

Eligibility criteria:
inclusion criteria: * to be between the ages of 18-35, * turkish as the mother tongue, * being literate, having a singleton pregnancy, * she has had nst at least once before, * 32 weeks or more gestation, * being multiparous, * having eaten at least two hours before the nst procedure, * volunteering to participate in the research. exclusion criteria: * having a high-risk pregnancy, * having a psychiatric disorder, * being pregnant with an urgent nst result, * smoking or drinking alcohol at least two hours before the nst procedure, * having any problem that prevents communication (such as hearing, speaking, ability to understand), having a visual, hearing, speech, physical or mental disability.
pilot study evaluating alterations in thrombogenicity and platelet reactivity following lower extremity arthroplasty

Conditions: Primary Total Hip and Knee Arthroplasty

Summary: this is a prospective, randomized study from pre-surgery to 6 weeks post-surgery designed to detect changes in coagulability following elective total knee and hip arthroplasty. patients will be randomized to one of the two standard prophylaxis treatments used at sinai hospital: 1. arixtra (2.5 mg sq/qd) subcutaneous injection daily for 2 weeks followed by aspirin 325 mg for 5 weeks, or 2. pneumatic compression stockings (mcs, active care, medical compression systems inc., israel) for 2 weeks with concomitant aspirin 325 mg daily for 5 weeks.


Eligibility criteria:
inclusion criteria: 1. men or women age ≥ 18 years old 2. total knee or total hip arthroplasty planned in the 60 days following study enrollment exclusion criteria: 1. pre-existing anti-coagulant therapy (heparin, lovenox, arixtra, warfarin, xarelto, and all other non-mentioned anticoagulants) on admission 2. history of bleeding diathesis 3. known active malignancy 4. prothrombin time \>1.5 x control 5. platelet count \< 100,000/mm3, hematocrit \< 30%, creatinine clearance \<30 ml/min 6. immunosuppression, e.g., human immunodeficiency virus (hiv) infection, chronic hepatitis b virus (hbv) or hepatitis c virus (hcv) infection, bacterial endocarditis 7. major surgery within past 3 months of enrollment 8. patients requiring bilateral arthroplasty 9. body weight \<50 kg (venous thromboembolism prophylaxis only) 10. unable to return to site for follow-up visit

Keywords: hip, knee, arthroplasty, venous thromboembolic events, blood loss
the effects of "workplace health promotion program" on pain, fatigue, stress in nurses

Conditions: Nurses; Work-Related Stress Disorder; Pain; Fatigue

Summary: pain, fatigue, and stress lead to decrease on their work performance with biopsychosocial functioning disorders on nurses. this study was conducted to examine the effects of the "workplace health promotion program" (whpp) on pain, fatigue, stress, professional quality of life (pro-qol) and coping skills for nurses.

the investigators conducted a randomized control trail in 30 nurses admitted to their hospital. progressive relaxation training, posture and breath exercises and ergonomic suggestion as a whpp was applied to the intervention group (n=15) during the five weeks. visual analogue scale (vas) was used to determine the pain, fatigue and stress levels of the nurses. brief cope and the professional quality of life scale, version 4 (pro-qol) were used to evaluate the coping skills and quality of life. the evaluations were performed three times on all the participants as; before and after training and the one-year follow-up. inclusion criteria of this study were working actively and at least 40 hours working in a week. participants who have psychiatric illnesses with or without medication, prior training or current use of relaxation therapy and participants without consent were excluded. eighty nurses aged between 18 and 65, working in a hospital have been informed about the study. forty-three nurses who met the criteria and signed consent forms were included in this study. whpp was pmr training, posture and breath exercises, and ergonomic suggestions.

Eligibility criteria:
inclusion criteria: * working actively and at least 40 hours working in a week, * working as a nurse. exclusion criteria: * have psychiatric illnesses with or without medication, * have prior training or current use of relaxation therapy and participants without consent.

Keywords: coping skill quality of life pain fatigue workplace health promotion program
pathophysiological mechanisms and implication of treatment in postural puncture headache

Conditions: Post-Dural Puncture Headache

Summary: to improve treatment for post dural puncture headache, its pathophysiology needs to be explored. dural puncture alters cns dynamics; using advanced mri, we aim to investigate pdphs pathophysiology explained by brain movement, cerebral blood flow, csf dynamics and the effect of epidural blood patch.

post dural puncture headache (pdph) is an iatrogenic and most common serious complication that can occur after a lumbar puncture or accidental dural puncture (adp), as is often the case in women receiving epidural analgesia (eda) during labour. it is linked to substantial distress for patients specially mothers during the postpartum period, resulting in difficulties in forming a satisfying emotional bond with their newborns. pdph is a clinical diagnosis, based on symptoms and chronology of events and is therefore subjective since it relies on the patients' descriptions of symptoms and the clinician's interpretation of those symptoms. despite the lack of clear understanding of the pathophysiology of pdph, several treatments have been suggested where an epidural blood patch (ebp) is considered the most effective option. even though application of an ebp carries risks, symptom-relief is almost instantaneous, and the treatment has been shown to shorten hospital stay. however, to improve treatment of these patients, a better understanding of its pathophysiology is needed to understand this condition more clearly. even though pdph is classified as a low-pressure headache it has been shown that the presence of pdph does not always relate to a low csf pressure nor does a normal pressure exclude pdph. our hypothesis is that the dural puncture, and the resulting outflow of csf, changes intracerebral hemodynamics and dynamics of the csf in a way that has never been fully investigated and described. using magnet resonance imaging (mri), including 4d phase contrast mri it will be possible to quantify changes in hemodynamics and csf dynamics in a new manner. the main objective of this study is therefore to investigate the effects of dural puncture on cerebral blood flow (cbf) and cerebrospinal fluid (csf) volume and pulsation and their relation to pdph. this project will help to better understand the pathophysiology of pdph and pave the way for improved management strategies in the future.

Eligibility criteria:
inclusion criteria: postural puncture headache age 20-40 exclusion criteria: * other central neurological disorders except the actual * acute medical condition * pregnancy * pacemaker, or other medical implants that are not mri-compatible * invasive procedures on the central nervous system or surgery on the spine or brain in the last 12 months.

Keywords: mri cerebral blood flow cerebrospinal fluid
lyr-220 for adult subjects with chronic rhinosinusitis (beacon study)

Conditions: Chronic Sinusitis; Chronic Rhinosinusitis (Diagnosis)

Summary: this study will assess the safety, tolerability, pharmacokinetics and efficacy of two lyr-220 designs in symptomatic adult chronic rhinosinusitis (crs) subjects who have had a prior functional endoscopic sinus surgery.

this is a phase ii, patient-blinded, two-part, randomized, parallel-group trial to evaluate the safety, tolerability, pharmacokinetics, and efficacy of lyr-220. the study will consist of two parts: part 1 will enroll up to 10 patients and is open label. part 2 is randomized, sham controlled and will enroll approximately 40 patients. the study follow-up duration is 28 weeks.

Eligibility criteria:
inclusion criteria: * diagnosis of chronic rhinosinusitis. * has had a prior bilateral total ethmoidectomy. * has computed tomography (ct) ethmoid cavity opacification. * has a sinonasal outcome test (snot-22) ≥ 20 at screening visit. * minimum cardinal symptom score. * has been informed of the nature of the study and has provided written informed consent as approved by the institutional review board (irb)/ethics committee (ec) of the respective clinical site or regulatory authority if applicable by national law. * agrees to comply with all study requirements. exclusion criteria: * pregnant or breast feeding. * known history of hypersensitivity or intolerance to corticosteroids. * history or clinical evidence or suspicion of invasive fungal sinusitis, allergic fungal rhinosinusitis, or atrophic rhinitis. * known history of hypothalamic pituitary adrenal axial dysfunction. * had dental procedure/implant on maxillary dentition within 4 weeks of the screening visit. * past or present functional vision in only one eye. * past, present, or planned organ transplant or chemotherapy with immunosuppression. * with prior cataract surgery or presence (in either eye) of posterior subcapsular cataract of grade 2 or higher, nuclear cataract of grade 3 or higher, or cortical cataract of grade 2 or higher or involving a minimum of center optic zone of 3 mm diameter. * ethmoidectomy that was unilateral or partial. * currently participating in an investigational drug or device study.