Kornimate/medical-research-clean huggingface dataset:
clinical study of pal-222 targeting patients with myopic chorioretinal atrophy (pamyca)

Conditions: Myopic Chorioretinal Atrophy

Summary: the goal of this clinical trial is to assess efficacy and safety in patients with myopic chorioretinal atrophy. the main question it aims to answer are: • percentage of changes in the chorioretinal atrophic area participants will be implanted one sheet of pal-222 into the subretinal space through pars plana vitrectomy. researchers will compare non-therapeutic eye to see if the changes is significant different.


Eligibility criteria:
inclusion criteria: * patients aged 20 years or older at the time of consent acquisition * patients with binocular intensity myopia (myopia of -6.0 diopter (d) or more) or patients with axial length (26 mm) or more equivalent to -6.0 d * corrected characters of the test eye patients with visual acuity of less than 60 characters (equivalent to decimal visual acuity 0.32) * patients diagnosed with binocular myopic chorioretinal atrophy and having atrophy of 1 papillary diameter (1.5 mm) or more in the area within 2 papillary diameter (3.0 mm) including the fovea centralis in the subject eye * patients without active choroidal neovascularization exclusion criteria: * patients with abnormal findings that pose a problem in clinical trial participation in screening tests. * patients with positive hepatitis b surface (hbs) antigen, hepatitis c virus (hcv) antibody, human immunodeficiency virus (hiv) antibody, human t-lymphotropic virus type 1 (htlv-1) antibody, syphilis serum reaction * patients with allergies to human serum albumin antibiotics, trypsin * patients with eye infections * patients with other retinal diseases (diabetic retinopathy, hypertensive retinopathy, vascular occlusion) * patients with confirmed optic nerve atrophy * patients with glaucoma who cannot control intraocular pressure * patients with findings associated with myopic traction macular disease (apparent posterior macular tumor, vitreous macular traction, retinal separation, macular hole detachment, macular hole) * patients with atrophy in all areas of the circle within 3 papilla diameter (4.5 mm) (9.0 mm in diameter) from the fovea * patients with corrected visual acuity of control eye 0.08 or less * patients with severe blood disorders, heart failure, liver disorders, and renal disorders * patients diagnosed with malignant tumor within 5 years or patients requiring treatment * pregnant women, lactating women, patients wishing to become pregnant during the trial period * patients who cannot discontinue anticoagulants or antiplatelet drugs before the trial * patients with drug addiction or alcoholism * patients receiving treatment with vascular endothelial growth factor inhibitor or photodynamic therapy within 4 months prior to transplantation for test eye or 2 months for reference eye. * patients who underwent eye surgery (excluding lens reconstruction) within 3 months before transplantation. in the case of cataract surgery, if 7 days or more have passed since surgery and postoperative inflammation is stable, registration is possible.

Keywords: regenerative product mesenchymal stem cell
optimizing metabolic control in type 1 diabetes - the automatic bolus calculator flash study

Conditions: Diabetes Mellitus, Type 1

Summary: this study aims to compare the effect of flash glucose monitoring (fgm) with traditional self-monitoring of blood glucose (smbg) with or without carbohydrate counting and automated bolus calculation, in patients with type 1 diabetes and poor metabolic control. the investigators will include in total 200 patients recruited from 5 clinical sites in the capital region of copenhagen. the patients will be randomized into four groups; a) standard diabetes training, i.e. group training in in general diabetes health issues, b) group training in carbohydrate counting and automated bolus calculation, the app mysugr will be taught and downloaded, c) group training as in group a, and instructed to use fgm, d) group training as in group b, and besides training in the use of the app mysugr, also instructed to use fgm. all patients are followed for 26 weeks with 6 clinical visits, group training (1 visit) and 2 telephone consultations. the primary outcome is time spent in normoglycemia.


Eligibility criteria:
inclusion criteria: * age \>/= 18 years * hba1c \> 53 mmol/mol * type 1 diabetes more than 1 year * treated with basal and bolus insulin. basal insulin can be taken once or twice daily. the percentage basal/bolus insulin should as judged by the investigator cover the patient's real need for basal insulin - if he or she is not eating and taking bolus * patients may or may not have knowledge on carbohydrate counting * patients may or may not have any experience with continuous glucose monitoring or fgm * patients have a personal smart phone * patients attend the outpatient clinic in one of the five study sites included in the study exclusion criteria: * use of an automatic bolus calculator on a daily basis within the last three months * daily use of continuous glucose monitoring or fgm on a daily basis within the last three months * use of insulin pump * use of neutral protamine hagedorn insulin as long acting insulin (insulatard, humulin retard) within the last three months * pregnant, breastfeeding, plan to get pregnant * gastroparesis * severe diabetes complications including proliferative retinopathy and myocardial infarction within the last six months * other concomitant medical or psychological condition that according to the investigator's assessment makes the patient unsuitable for study participation as e.g. alcohol and drug abuse * current participation in another diabetes-related clinical trial that, in the judgment of the principle investigator, will compromise the results of the study or the safety of the subject * use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to study start * inability to understand the individual information and to give informed consent

Keywords: hyperglycemia hypoglycemia carbohydrate counting automated bolus calculation flash glucose monitoring
taste and local tolerance study of nla nasal spray in patients with allergic rhinitis

Conditions: Allergic Rhinitis

Summary: evaluation of nla nasal spray with regard to taste perversion and local tolerance

oral or intranasal antihistamines is the first line treatment for allergic rhinitis. cetirizine is a second-generation selective antihistamine widely used in an oral formulation for the treatment of allergic rhinitis. local administration of cetirizine has been shown to reduce symptoms after allergen challenge, and has the potential to shorten the time to onset and decrease systemic side effects. however, local irritation and nasal burning/pain has been reported after nasal administration. for the compliance of the patients taking a nasal spray, the taste and tolerance of the product is of particular importance. nla nasal spray contains cetirizine in a liposomal formulation aiming to improve the tolerability. the present study aims to compare the nla nasal spray with cetirizine in an aqueous formulation and placebo with regard to taste perversion and local tolerance. this will be investigated off-season in patients with seasonal allergic rhinitis after provocation with allergen.

Eligibility criteria:
inclusion criteria: * 18 to 50 years of age (inclusive) * body mass index (bmi) between 18 and 28 kg/m2 * history of pollen-induced seasonal allergic rhinitis for at least two years and otherwise healthy * elevated specific ige to at least one aero allergen or at least one positive skin pick test (spt) * seasonal allergic rhinitis with symptoms provoked by the allergen with a corresponding elevated specific ige or positive spt * signed written informed consent exclusion criteria: * perennial allergic rhinitis except for cat and/or dog sensitivity under the condition that these patients are not exposed to cats and dogs * soy bean allergy * peanut allergy * smoking during the last month before study inclusion * any upper respiratory tract infection during the period of 2 weeks before the start of the study * chronic medication * any medication, including herbal medicines, during their last five half-lives (t½) * nasal anatomical deviations * extensive use of nasal sprays as judged by the investigator * ongoing nasal symptoms as judged by the investigator * known hypersensitivity to cetirizine * pregnant or breast-feeding women * fertile women not using reliable methods of contraception (i.e. iud, barrier method, hormonal contraceptives, abstinence) * participation in any other investigational study in the last three months * inability to adhere to the study plan * previous inclusion in this study * blood donation during the last three months

Keywords: allergic rhinitis nasal spray anti-histamine tolerability
personality disorders and substance use disorders in a sexual context in the man having sex with other men population

Conditions: Substance Use Disorders

Summary: chemsex refers to the use of psychoactive drugs in a sexual context, mainly cathinones, ghb/gbl, methamphetamine, cocaine and ketamine. this can cause infectious or psychiatric complications, addictions, and often goes with high risk sexual behaviours. recent studies have highlighted the relationship between personality disorders, substance use disorders and risky sexual behaviours. it is important to understand the factors associated with chemsex in order to offer adapted prevention and care plans. the study hypothesis is that personality disorders, evaluated with the pdq-4+ questionnaire, are more frequent among man having sex with other men with a substance use disorder linked to chemsex than among man having sex with other men who have never practised chemsex.


Eligibility criteria:
inclusion criteria: * age over 18 * men who have sex with men * no opposition to participate to the study * chemsex group: to attend an addiction care center for past or present mild, moderate or severe substance-related disorder(s) according to dsm-v criteria, occurring in a sexual context and concerning cathinones, ghb/gbl, methamphetamine, cocaine and/or ketamine. * control group: to consult for a prep prescription and never have used cathinones, ghb/gbl, methamphetamine, cocaine or ketamine before or during sex. exclusion criteria: * deprivation of liberty * guardianship * chemsex group: simple experience of chemsex without substance use disorder
delayed-enhancement cardiovascular magnetic resonance in patients with sarcoidosis

Conditions: Sarcoidosis

Summary: the primary objective of this study was to determine the ability of cardiac magnetic resonance (cmr) to identify cardiac involvement in patients with sarcoidosis. patients were to undergo cmr in addition to routine clinical evaluation.

in patients with sarcoidosis, cardiac death is a leading cause of mortality which may represent unrecognized cardiac involvement. cardiovascular magnetic resonance (cmr) can detect cardiac involvement including minute amounts of myocardial damage. therefore, the objective of this study was to determine the usefulness of cmr and compare it with standard clinical evaluation for cardiac involvement. patients with documented extracardiac sarcoidosis or clinically suspected cardiac sarcoidosis will be enrolled.

Eligibility criteria:
inclusion criteria: * biopsy proven sarcoidosis * suspected cardiac sarcoidosis exclusion criteria: * contraindication to mri

Keywords: sarcoidosis cardiac magnetic resonance
effectiveness of interventional therapy for non-flow-limiting vulnerable plaques

Conditions: Coronary Arterial Disease (CAD); Vulnerable Coronary Plaques; Thin-cap FIbroatheroma; Acute Coronary Syndromes (ACS)

Summary: the aim of this clinical trial is to explore the optimal preventative treatment strategy for non-flow-limiting vulnerable plaques. the main question it aims to answer is: can interventional therapy further improve the outcome of non-flow-limiting vulnerable plaques on top of optimal pharmacologic therapy? researchers will randomly assign patients who meet the inclusion criteria to preventative intervention plus optimal drug therapy (experimental group) or optimal drug therapy alone (control group). participants will: assigned to the control group: optimized drug therapy consisting of lifestyle improvement and intensive drug therapy including anti-inflammatory therapy (colchicine 0.5 mg/day) while receiving high-dose statin or other therapy to achieve target levels (low-density lipoprotein cholesterol \<1.4 mmol/l). lifestyle improvement and risk factor management included smoking cessation, nutritional optimization, physical activity, compliance with prescribed medications, and control of diabetes and hypertension. assigned to the experimental group: all non-flow-limiting vulnerable plaques were treated with conventional second-generation drug-eluting stents or drug balloons. after the procedure, participants received dual antiplatelet therapy for about 12 months as well as other medications in the control group.


Eligibility criteria:
inclusion criteria: * aged 18-80, male or non-pregnant female * clinical diagnosis of acs * willing and able to provide written informed consent * at least one significant stenosis (\>50% diameter stenosis) with ffr or qfr \>0.8, meeting the following: oct-defined thin-cap fibroatheroma (fibrous cap thickness \ 90°) * reference vessel diameter: 2.5-4.0 mm * lesion length ≤ 40 mm exclusion criteria: * contraindications to dual antiplatelet therapy or planned discontinuation within one year * severe comorbidities with a life expectancy of less than two years * planned cardiac or major non-cardiac surgery * pregnancy, breastfeeding, or planned pregnancy during the study * left ventricular ejection fraction \<35% * estimated glomerular filtration rate \<30 ml/min/1.73m² * allergy to contrast agents, drug-eluting stents, or deb drugs * participation in other clinical studies * preferred treatment is cabg * severely calcified or angulated target lesion * target lesion requiring dual stent technique * left main disease * previously stented target lesion * target lesion in a graft vessel

Keywords: optical coherence tomography (oct) percutaneous coronary intervention (pci) randomized controlled trial (rct) optimal medical therapy colchicine fractional flow reserve (ffr) percutaneous coronary angioplasty (ptca) drug eluting ballon (deb)
quality of life and psychological strengths of older people

Conditions: Quality of Life; Skills, Coping

Summary: as the 2019 coronavirus pandemic (covid-19) overspreads around the world, and scientists try to elucidate about the complexity of the virus, there is clear potential for it to become a long-lasting global illness. in this picture, spain has emerged as one of the most affected countries with a high prevalence rate. the possibility of illness or even death, the uncertainty of the future, or the required physical estrangement, make this epidemic a highly stressful situation with potential long-term consequences on the physical and psychological wellbeing of the population, just isolation raises the probability of health problems like depression and anxiety. however, the same event does not affect everybody equally. the ultimate effect of a stressor will depend on its appraisal as a threat and the resources the person counts on to copy and several biopsychosocial variables could play an important role, as risk or protective factors.

the intervention program "how to improve your strengths and quality of life" consists of 8 individual sessions. the sessions take place weekly, so the total duration of the program is 8 weeks. each session lasts approximately 1 hour. the sessions will be held both in person and online. following the principles of the psychoeducational therapy and positive psychology, this program is focused on the enhancement of personal strengths and quality of life of the elderly. specifically, during the sessions, the following topics will be worked on: resilience, gratitude, acceptance, family functioning and quality of life in its different dimensions (control, autonomy, pleasure and self-fulfillment).

Eligibility criteria:
inclusion criteria: * be at least 60 years of age. * residing in spain. * not having a diagnosed neurological disease or severe psychopathological disorder, or other ailment that is incompatible with the understanding of the questionnaires or the intervention program. * acceptance and signature of the informed consent. exclusion criteria: * do not comply with the established age range. * present an ailment that makes them unable to respond to the questionnaire.

Keywords: elderly quality of life strengths
swallowing impairments in icu survivors and community-dwelling adults

Conditions: Dysphagia; Healthy Aging; Post Intensive Care Syndrome; Caregiver Burden

Summary: post-intensive care syndrome (pics), which consists of physical, cognitive, and psychosocial problems, is a pervasive complication for older intensive care unit (icu) survivors and contributes to detrimental health outcomes and significant reductions in quality of life. yet, little is known about the relationship between pics, swallowing difficulties (dysphagia), and other icu-related negative outcomes such as frailty and alzheimer's disease and related dementias (adrd). the primary purpose of this research study is to determine the prevalence and severity of dysphagia, risk factors for dysphagia development, recovery patterns of dysphagia over time, and the impact of dysphagia on health outcomes, quality of life, and care partner burden in adult icu survivors with pics.

this study will involve one in-person research visit for community dwelling adults and two research visits for critically ill adults (one in the icu, one 3-months post-hospital discharge) that will last approximately 1 hour and will consist of a screening, cough testing, swallow function testing, assessments of hand grip and tongue strength, and completion of questionnaires. caregivers of icu survivors will complete questionnaires at the 3-month follow up visit.

Eligibility criteria:
inclusion criteria community-dwelling adults: 1. adult ≥18 years old 2. no prior history of neurological diseases or respiratory diseases 3. no prior history of head and neck surgery/head and neck cancer/radiation to head and neck region 4. no prior history of dysphagia. exclusion criteria community-dwelling adults: 1. \<18 years old 2. neurological disease or respiratory disease diagnosis 3. history of head and neck cancer/surgery to the head and neck region 4. history of dysphagia. inclusion criteria critically-ill adults: 1. adult ≥ 18 years old 2. icu patients requiring monitoring or treatment for respiratory failure and/or shock (e.g., hypovolemic, septic, and/or cardiogenic) 3. cognitive capacity and willingness to provide informed consent 4. medically stable for testing (e.g., can sit upright, respiratory status is stable \[sp02 \> 90%, off mechanical ventilation or cpap/bipap for \> 30 minutes, respiratory rate \< 30 bpm\], and richmond agitation-sedation scale score is 0 (awake and alert). exclusion criteria critically ill adults: 1. neurological disease diagnosis 2. history of head and neck cancer/surgery to the head and neck region 3. history of dysphagia prior to icu admission. inclusion criteria caregivers: 1. caregiver of critically ill adult who meets inclusion criteria for study 2. willing to complete questionnaire. exclusion criteria caregivers: 1. not a caregiver of critically ill adult 2. unwilling to complete questionnaire.
feasibility and safety of ketamine for suicidal patients in the emergency department

Conditions: Suicide; Suicidal Ideation; Depression

Summary: there is currently no readily available pharmacologic intervention for suicidal ideation, a true psychiatric emergency, in the emergency department (ed). investigators aim to trial low-dose, intravenous ketamine, a drug with well-established use in treatment-resistant depression, for patients who present to the ed with suicidal ideation.

in this phase one trial, the investigators' objective is to establish the safety and feasibility of the study dose and route of administration, as well as to provide preliminary data on efficacy in reduction of depressive and suicidal symptoms as well as length of stay. select patients will be given 0.2mg/kg of ketamine iv and observed in the ed for two hours. vital signs and symptoms will be monitored. patients will then be transferred to an admitting psychiatric hospital for definitive care as per standard of care. surveys will be administered at times 0, 2 hours, 24 hours, and 72 hours to assess depressive and suicidal symptoms. ed providers and nursing staff will be asked to complete a short survey assessing ease of use and feasibility for ed administration for this purpose. specific aims are as follows: 1. to determine the safety of ketamine as a single iv dose in the ed for acutely suicidal patients. 2. to determine the feasibility of ketamine administration in the ed for the acutely suicidal patient. 3. to determine the impact of ketamine administration on depression and suicidal ideation in the acute phase as measured by the madrs and c-ssrs. 4. to determine the impact on hospital length of stay calculated from ed arrival until discharge from admitting psychiatric hospital.

Eligibility criteria:
inclusion criteria: * acutely suicidality ("yes" answer to any of items 4 or 5 on c-ssrs "suicidal ideation" category) * require inpatient stabilization for si or actions based on clinical observation and interview * are accepted for psychiatric stabilization at the university of kansas medical center's strawberry hill campus * have a glasgow coma score (gcs) of 15 * age 18-65 exclusion criteria: * current or past history of psychosis * current or recent (past 4 weeks) symptoms of mania/hypomania as defined by young mania rating scale (yrms) score of 12 or greater * history of ketamine use disorder * history of liver transplant * pregnancy or breastfeeding * imprisonment or inability to consent * positive urine drug screen or serum alcohol level * hypertension (sbp \> 160 or dbp \> 100 before administration of ketamine) * hypotension (sbp \< 90) * presence of acute medical condition requiring admission to medical service * allergy, intolerance, or previous adverse reaction to ketamine * patient has 8+ lifetime ketamine exposures * the treating physician determines that the patient is not a good candidate for the study (e.g. medical condition/procedure, medication that would contradindicate ketamine treatment)