Kornimate/medical-research-clean huggingface dataset:
feasibility of generating pluripotent stem cells from patients with familial retinoblastoma

Conditions: Retinoblastoma

Summary: the goal of this study is to determine if human rb1-deficient induced pluripotent stem cells (ipscs) can produce retina, and, furthermore, can give rise to retinoblastoma in culture. this unique opportunity to study the initiation of retinoblastoma in the developing retina will shed light on the cell of origin for retinoblastoma and allow the investigators to study the earliest molecular and cellular events in retinoblastoma tumorigenesis. objectives: * to establish the feasibility of producing induced pluripotent stem cells (ipscs) from retinoblastoma patients with germline rb1 mutations (rb1-deficient ipscs). * to validate human rb1-deficient ipscs by confirming karyotype, pluripotency and rb1 mutation. * to differentiate the rb1-deficient ipscs into retina as a model of the initiation of retinoblastoma in the developing retina.

this is an observational study where a small skin cell sample or peripheral blood sample will be used to produce ipscs. after rb1-deficient ipscs are produced, their karyotype and rb1 mutation will be confirmed and their pluripotency will be tested by studying the expression of pluripotent genes and proteins according to standardized guidelines established for human ipscs. after validation of the rb1-deficient ipscs, they will be differentiated in the laboratory into retina following established protocols.

Eligibility criteria:
inclusion criteria: * research participant with heritable retinoblastoma and one of the following criteria: * family history with rb1 mutation identified * diagnosis of bilateral retinoblastoma * diagnosis of unilateral retinoblastoma with rb1 mutation or mycn amplification identified * participant or legal guardian/representative is able and willing to provide written informed consent. exclusion criteria: * participants who do not meet the inclusion criteria will be excluded.

Keywords: heritable retinoblastoma familial retinoblastoma pluripotent stem cells
the effect of psychosocial skills focused group psychoeducation in schizophrenia patients

Conditions: Schizophrenia Patients; Psychoeducation; Functional Status; Treatment Outcome; Mental Development

Summary: the aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. this research will be conducted in giresun community mental health center. the study was planned as a randomized controlled pretest-posttest design. in addition to the sociodemographic information form prepared by the researchers, the functional recovery scale in schizophrenia, the modified morisky treatment adherence scale and the warwick-edinburgh mental well-being scale will be used to collect the data. the sample size was calculated as 34 people (experimental group= 17, control group= 17). forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation.

the aim of this study was to evaluate the effect of psychosocial skills-oriented group psychoeducation on functional recovery, treatment adherence and mental well-being in patients with schizophrenia. this research will be conducted in giresun community mental health center. the study was planned as a randomized controlled pretest-posttest design. in addition to the sociodemographic information form prepared by the researchers, the functional recovery scale in schizophrenia, the modified morisky treatment adherence scale and the warwick-edinburgh mental well-being scale will be used to collect the data. the sample size was calculated as 34 people (experimental group= 17, control group= 17). forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation. forms and scales will be applied to the experimental and control groups before psychoeducation and scales will be applied again to both groups after psychoeducation. thus, the effect of the psychoeducation program on the determined parameters will be evaluated. after the completion of the research, short-term counseling services will be provided to the control group in line with ethical principles. spss 25 package program will be used for data analysis.

Eligibility criteria:
inclusion criteria: 1. having a diagnosis of schizophrenia according to dsm-5 diagnostic criteria 2. to have continuity in the community mental health center 3. being in remission (period without psychotic exacerbation) as a result of the evaluation of the outpatient clinic doctor, 4. to be mentally capable of understanding the questions posed 5. to have the cognitive competence to understand the training provided 6. not having any visual or auditory disability 7. graduating from at least primary school exclusion criteria: 1. refusing to participate in the study 2. being under 18 years of age 3. being illiterate in turkish 4. having mental retardation

Keywords: schizophrenia psychoeducation functional recovery treatment adherence mental well-being
peruconplasma: evaluating the use of convalescent plasma as management of covid-19

Conditions: COVID-19

Summary: open label controlled clinical trial to evaluate the safety and efficacy of the use of convalescent plasma in hospitalized patients with covid-19 infection. this study will have two arms, one arm will receive convalescent plasma plus standard of care, and the other arm will receive standard of care only. adults older than 18 years old, hospitalized with diagnosis of covid-19 confirmed by a laboratory test (molecular or serology), with severe or life-threatening disease, will be included to the study after obtaining inform consent by the patient of a direct family member. participants will be then randomized 1:1 to the experimental and the control groups. participants at the experimental group will receive 1 to 2 units of abo compatible covid-19 convalescent plasma (200 ml to 250 ml each) within 48 hours, in addition to the standard of care. participants at the control group will receive standard of care. safety of convalescent plasma administration will be evaluated, as well as other indicators of clinical efficacy.

the study protocol can be found in: https://trialsjournal.biomedcentral.com/articles/10.1186/s13063-021-05189-6

Eligibility criteria:
inclusion criteria: * hospitalized 18 years old or older patient with covid-19 disease, confirmed by a molecular test or a serologic test, along with a typical covid-19 clinical presentation. * severe or critical disease caused by covid-19 severe disease is defined as 2 or more of the following criteria: * respiratory frequency \>22 * o2 saturation ≤93% * pao2 50mmhg * pao2/fio2 \<300 * or critical disease with one or more of the following criteria: * respiratory insufficiency with requirement of mechanical ventilation within the last 72hours * shock * inform consent signed by patient or direct family member. exclusion criteria: * contraindication for transfusion (history of trali or taco, history of anaphylaxis to blood components * multiorgan failure, defined by a sofa score of \>5 * hemodynamically unstable, with mean arterial pressure \<60 mmhg, refractory to vasopressors use * uncontrolled concomitant infection * disseminated intravascular coagulation * myocardial infarction * acute coronary disease * patient on dialysis * intracranial bleeding active within the last 7 days * pregnancy

Keywords: covid-19 convalescent plasma
the effect site concentration of remifentanil for conscious sedation during awake nasotracheal fiberoptic intubation

Conditions: Cervical Disc Herniation; Cervical Spinal Stenosis; Cervical Spine Damage

Summary: remifentanil provides analgesia, suppresses airway reflex, has little effect on cognitive function. it can be used for conscious sedation during awake nasotracheal fiberoptic intubation. target-controlled infusion is more reliable technique for maintaining optimal infusion rate than manual controlled infusion. the aim of this study is to determine the effect site concentration of remifentanil for successful conscious sedation during awake nasotracheal fiberoptic intubation.


Eligibility criteria:
inclusion criteria: * patients undergoing cervical spine surgery * age 20-65 * american society of anesthesiologists physical status classification i or ii exclusion criteria: * patients' refusal * allergy to any drug used * unable to cooperate * severe hepatic or renal disease * coagulation disorder * chronic use of opioids or sedatives * increase risk of pulmonary aspiration.
phase 1 study of biib022 (anti-igf-1r monoclonal antibody) in relapsed/refractory solid tumors

Conditions: Solid Tumors

Summary: phase 1, open-labeled, dose escalation safety and tolerability study for the treatment of subjects with relapsed or refractory solid tumors.


Eligibility criteria:
inclusion criteria: * age 18 years or older at the time of informed consent * relapsed or refractory solid tumors following standard therapy. * ecog performance status 0 or 1. exclusion criteria: * history of insulin-dependent diabetes, type 2 diabetes, or hemoglobin a1c \>6% at screening. * history of myocardial infarction within 12 months prior to day 1 or chronic heart failure. * known central nervous system or brain metastases. * prior anti-igf-1r therapy of any kind. other protocol-defined inclusion/exclusion criteria may apply.

Keywords: relapsed refractory solid tumor
k01 impacts of lingual endurance exercise

Conditions: Dysphagia; Dysphagia, Oropharyngeal; Ischemic Stroke

Summary: swallowing impairments (dysphagia) frequently occur after stroke and have devastating consequences on overall health and quality of life, and long-term deficits in swallow function also increase risk of morbidity (e.g. depression) and mortality (i.e. aspiration pneumonia). as such, rehabilitation of swallow function to improve safety and efficiency of swallowing is essential in this population. this study aims to: 1) provide preliminary data to evaluate the effect of a novel lingual endurance exercise on swallow function in individuals with post-stroke dysphagia; and 2) collect preliminary data regarding changes in white matter tract diffusion and cortical thickness and from mri data to better understand effects of lingual exercise training on neuroplasticity.

this pilot trial will evaluate the effect of lingual endurance exercise (vs sham exercise) on recovery of swallow function after stroke. the primary aim of this study is to evaluate effects of lingual endurance exercise vs sham on swallow function in individuals with post-stroke dysphagia. the investigators hypothesize that lingual endurance training will result in greater improvement in measures of oral swallow physiology as compared to sham. regardless of outcome, this dataset will provide innovative and highly novel information regarding the relationship between lingual function, swallowing impairments, and cortical representation of dysphagia in a post stroke population. these pilot data will be essential in providing sufficient power for designing an r01 phase ii intervention trial to investigate how to maximize gains with timing and intensity of therapy delivery to better recover swallow function after stroke.

Eligibility criteria:
inclusion criteria: * 1) 3-6 months since most recent diagnosis of ischemic, confirmed from clinical imaging) with or without small hemorrhagic transformation (hi-1) * 2) have some indication of on-going swallowing issues * 3) english speaking exclusion criteria: * 1) ≤18 years of age * 2) history of dysphagia prior to or after the stroke caused by any of the following conditions: gastrointestinal disease, traumatic brain injury, head and neck cancer, surgery involving the pharynx or larynx * 3) history of other neurological disease (i.e. multiple sclerosis, als, parkinson's, dementia). * 4) medium to large hemorrhagic transformation/involvement documented on clinical stroke imaging 5) 5) history of temporomandibular joint and muscle disorders (also known as tmj).
cholecalciferol comedication in ibd - the 5c-study

Conditions: Inflammatory Bowel Diseases

Summary: vitamin d deficiency (defined as 25(oh)-vitamin d serum level \<50 nmol/ l) is associated with irritable bowel disease (ibd). national guidelines recommend the administration of 800 -4000 iu cholecalciferol daily for an effective treatment, especially during the winter (poor sun exposition). cumulative intermittent administration monthly or weekly is possible. the study aims to compare inflammation activity (primary outcome) after monthly or weekly treatment with soft capsules containing 24'000 iu cholecalciferol compared to no vitamin d supplementation. quantification of 25(oh)-vitamin d serum values is a secondary outcome. the investigators will use newly developed soft capsules.

monthly supplementation: monthly administration of a capsule containing 24'000 iu vitamin d, corresponding to a dose of approximately 800 iu per day, as comedication to the usual treatment during 6 months. weekly supplementation: weekly administration of a capsule containing 24'000 iu vitamin d, corresponding a dose of approximately 3500 iu per day, as comedication to the usual treatment during 6 months. control: usual treatment without vitamin d supplementation. all 3 groups: in a follow-up phase of 6 months, all participants can choose whether they want a monthly vitamin d supplementation or not.

Eligibility criteria:
inclusion criteria: * diagnosis of crohn disease or ulcerative colitis exclusion criteria: * hypercalcaemia
study of meningococcal b vaccine and acwy conjugate vaccine in healthy adults

Conditions: Meningococcal Meningitis, Serogroup A; Meningococcal Meningitis, Serogroup B; Meningococcal Meningitis, Serogroup C; Meningococcal Meningitis, Serogroup Y; Meningococcal Meningitis, Serogroup W

Summary: the study involves the measurement of immune response to vaccination with three doses of a meningococcal b vaccine and a single dose of a meningococcal acyw conjugate vaccine in healthy adults (laboratory workers). the study will be completed at the manchester medical microbiology partnership in the uk and will enrol staff who may be at potential occupational exposure to meningococci. blood samples will be taken before and after each vaccination and used to determine if the vaccines induce protective responses.

laboratory staff at the manchester medical microbiology partnership may be at potential occupational exposure to meningococci. no licensed vaccine is available against serogroup b meningococci and the available plain polysaccharide serogroup acyw vaccine is poorly immunogenic. novartis vaccines have developed an investigational serogroup b vaccine and a conjugated acyw vaccine. this study will investigate these vaccines ability to induce a protective response in laboratory staff from the manchester medical microbiology partnership. three doses of the meningococcal b vaccine will be administered at 0, 2 and 6 months and a single dose will be administered at 0 months. blood samples will be taken before and after each vaccination and functional antibodies determined.

Eligibility criteria:
inclusion criteria: * aged 18-65 years of age * who have given written informed consent after the nature of the study has been explained. * who work within the manchester medical microbiology partnership and may be at potential occupational exposure to meningococci. exclusion criteria: * the possibility of pregnancy * a serious chronic disease including progressive neurological disease or seizure disorder. * have a known bleeding diathesis, or any condition that may be associated with a prolonged bleeding time. * have a history of severe allergic reactions after previous vaccinations such as anaphylactic shock, asthma, urticaria, or other allergic reaction or hypersensitivity to any vaccine component. * have received another investigational agent within 90 days or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another investigational trial through the end of the study.

Keywords: meningococcal vaccine meningitis
body composition study in critically ill patients-extended to covid-19

Conditions: Critical Illness; Covid19; Muscle Atrophy; Muscle Strength

Summary: muscle loss (ultrasound quadricep muscle) and muscle strength (handgrip and knee extension strength) will be compared between covid-19 and non covid-19 critically ill patients.

given the heightened inflammatory status among covid-19 critically ill patients, we hypothesized that the rate of skeletal muscle loss is accelerated in this population, and this loss is even more pronounce than the general critically ill patients. we further hypothesized that the increased muscle loss will lead to worse functional outcome (lower muscle strength) in covid-19 critically ill patients compared with age- and sex-matched non-covid-19 critically ill patients, as it has been shown that quadriceps thickness is strongly correlated with functional status at icu discharge. furthermore, a recent systematic review and meta-analysis in survivors of coronavirus (severe acute respiratory syndrome, sars or middle-east respiratory syndrome, mers, or covid-19) also demonstrated reduced exercise capacity and quality of life at 6 months after hospitalization or icu admission

Eligibility criteria:
inclusion criteria: * ≥ 18 years old * admitted into the icu due to covid-19 exclusion criteria: * likely to transfer out from the icu in 24 hours from screening * likely to die in the next 7 days * bedbound prior to hospital admission or bedbound in the hospital for \>10 days
the impact of caffeine on brachial endothelial function in healthy subjects and in patients with ischemic heart disease

Conditions: Coronary Disease

Summary: prior work (chris, m. et al, clinical science 2005; 109, 55-60) has demonstrated that drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent fmd (flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy adults subjects. this effect might be attributed to caffeine, given that decaffeinated coffee (\<2 mg of caffeine) was not associated with any change in endothelial performance. in the current study we intend to further examine the impact of caffeine on brachial endothelial function among healthy subjects \& in patients with proven ischemic heart disease.

background: prior work (chris, m. et al, clinical science 2005; 109, 55-60) has demonstrated that drinking a cup of coffee (80-100 mg of caffeine) an hour before endothelium-dependent fmd (flow-mediated dilatation) of the brachial artery, effects endothelial function in healthy adults subjects. this effect might be attributed to caffeine, given that decaffeinated coffee (\<2 mg of caffeine) was not associated with any change in endothelial performance. in the current study we intend to further examine the impact of caffeine on brachial endothelial function among healthy subjects \& in patients with proven ischemic heart disease. aim: to evaluate the impact of 200 mg caffeine tablet intake (equivalent to 2 cups of coffee), compared to placebo on brachial endothelial function in healthy subjects \& in patients with proven ischemic heart disease. methods: 1. patients will be invited for two endothelial function tests 1 week apart. 2. ecg, heart rate \& blood pressure will be recorded at rest prior to each test. 3. following overnight fasting and discontinuation of all medications for ≥ 12 hours and absence of \> 48 hour caffeine consumption, patients will receive 200 mg of caffeine tablets or placebo, in a double-blind, cross-over study design. an hour later the patient will undergo endothelium-dependent flow-mediated dilation (fmd) and endothelium-independent, nitroglycerin (ntg)-mediated vasodilation will be assessed non-invasively in the brachial artery, using a high resolution (15 mhz) linear array ultrasound. 4. prior to and after the fmd, blood will be drawn to test caffeine levels, adiponectin, cbc, electrolytes, crp and lipids.

Eligibility criteria:
inclusion criteria: * patients with documented ischemic heart disease * healthy subjects who are not heavy regular coffee drinkers exclusion criteria: * patients with unstable angina pectoris * patients with acute or chronic heart failure * patients with cardiac arrhythmia

Keywords: coronary disease atherosclerosis endothelial function caffeine cerebrovascular disease prevention
prospective evaluation of 68-ga-prostate specific membrane antigen (psma)-positron emission tomograph (pet) and early prostatic specific antigen (psa) kinetics during salvage radiotherapy for personalizing the management of men with relapse of prostate cancer after radical prostatectomy

Conditions: Relapsed Prostate Cancer

Summary: this is an open-label, phase ii trial in patients with psa recurrence after prostatectomy. patients entering the study will all receive initial 50 gray (gy) radiotherapy (25 x 2gy) to the prostate bed and thereafter be classified as either responders or non-responders depending on psa response at fifth week of radiotherapy. a 68-ga- psma-pet is done before start of radiotherapy, and analyzed before fifth treatment week in order to identify cancer lesions in patients with poor psa response. patients with psa response after 5 weeks of radiotherapy will not receive any subsequent therapy, whilst patients with poor psa response may be in need for additional therapy such as radiotherapy to lymph node metastases and/or boost fractions to local recurrence. patients with more than 3 lymph node metastases or distant metastases will not receive any more radiotherapy, but individualized systemic therapy will be started.


Eligibility criteria:
inclusion criteria: * histological evidence of prostate cancer in the radical prostatectomy specimen * at least 2 rising psa values, of which the last ≥ 0.15 ng/ml * tumor, regional nodes, metastasis (tnm): any t, n0/x, m0/x * age: 18 years or older * world health organization (who) performance status 0-1 * life expectancy \> 10 years * adequate laboratory findings: hematological: hemoglobin \> 90 g/l (may be transfused to maintain or exceed this level) absolute neutrophil count (anc) ≥ 1,0 x 109/l, platelets ≥ 75 x 109/l hepatic: bilirubin ≤ 1.5 x upper limit of normal (uln), alanine aminotransferase (alat) ≤ 5 x uln renal: creatinine ≤ 1.5 x uln * signed written informed consent * the patient must be able to comply with the protocol exclusion criteria: * evidence of metastasis on imaging or in specimen (e.g. n1 at lymph-node dissection) * prior or ongoing treatment with hormones (antiandrogens, gnrh) * prior radiotherapy to the pelvis * previous malignancy other than prostate cancer and basalioma the past 5 years. * clinically significant (i.e. active) cardiovascular disease e.g. myocardial infarction (≤ 6 months), unstable angina, new york heart association (nyha) grade iii-iv congestive heart failure * severe pulmonary disease e.g. pulmonary fibrosis * any other serious or uncontrolled illness which in the opinion of the investigator makes it undesirable for the patient to enter the trial