Kornimate/medical-research-clean huggingface dataset:
topical sirolimus in chemoprevention of facial squamous cell carcinomas in solid organ transplant recipients (siroskin)

Conditions: Solid Organ Transplant Recipients; Skin Cancer

Summary: 01.21 siroskin is a phase 3, double-blind, multi-centre, parallel-arm, randomised, placebo-controlled trial to evaluate the use of topical 1% sirolimus in the chemoprevention of skin cancer, versus placebo, applied every night for 24 weeks in solid organ transplant recipients.

keratinocyte carcinomas are a major burden affecting mortality and morbidity in solid organ transplant recipients (sotrs). due to an increased prevalence of skin cancers, sotrs require recurrent skin checks and frequent skin cancer surgery. the gold standard of treatment is surgery, enabling complete remission and a cure in the majority of cases. despite this, there is no effective way of preventing new cancers from developing in the same area. oral sirolimus is a selective immunosuppressant agent which has proven to reduce the burden of skin cancer; however, it is poorly tolerated due to side effects. topical sirolimus has proven effective in reducing the skin cancer burden in animal models and is safe on the face of patients with tuberous sclerosis. an initial 12-week phase ii clinical trial recently conducted by the research team suggested topical sirolimus to be safe and effective, as it reduced the early signs of skin cancer without any major side effects. in this phase iii randomised, double-blind, placebo-controlled study, we propose using 1% topical sirolimus applied to the face on a regular basis for 24 weeks. we aim to determine whether this topical cream can fill a major gap in our current therapies by reducing the onset of new skin cancers and therefore reduce the burden of disease in terms of number of biopsies and surgeries, and potential hospitalisations and death.

Eligibility criteria:
inclusion criteria: 1. be aged 18 years or older and able to provide consent 2. have received an organ transplant equal to or greater than 12 months prior to consent 3. have had at least 1 scc/bcc in the past 5 years 4. have at least 5 keratotic lesions on their face at inclusion exclusion criteria: 1. are currently receiving sirolimus or everolimus orally\* 2. have a skin cancer on their face requiring excisional surgery\*\* 3. have an open wound on their face requiring treatment 4. are pregnant or planning to become pregnant in the next 6 months 5. anticipate elective medical events which may prevent daily cream application. 6. are unable to provide informed consent, complete questionnaires and attend trial site for visits 7. are participating in another clinical trial with an investigational drug/device aiming to reduce skin cancers or affect level of immunosuppression 8. planning to move overseas within 2 years (\*)patients are eligible to join the study after ceasing treatment and after a washout period of 16 days for sirolimus and 8 days for everolimus. (\*\*) once treatment of the lesion is completed these patients can be re-screened.
a study to determine the safety, tolerability, and efficacy of shr-1209 in patients with familial hypercholesterolemia

Conditions: Familial Hypercholesterolemia

Summary: the study is being conducted to evaluate the efficacy, safety and tolerability of shr-1209 in subjects with familial hypercholesterolemia. 8 eligible patients (aged ≥18 years) with familial hypercholesterolemia, on stable maximum tolerable dose lipid-regulating therapy for at least 28 days, to receive subcutaneous shr-1209, follow up 8 weeks. the primary endpoint was percentage change in ldl cholesterol from baseline at week 12 .


Eligibility criteria:
inclusion criteria: * males and females ≥ 18 years of age * diagnosis of homozygous familial hypercholesterolemia * stable lipid-lowering therapies for at least 28 days * ldl cholesterol ≥ 130 mg/dl (3.4 mmol/l) * triglyceride ≤ 400 mg/dl (4.5 mmol/l) * bodyweight of ≥ 40 kg at screening. exclusion criteria: * ldl or plasma apheresis within 8 weeks prior to randomization * new york heart association (nyha) class iii or iv or last known left ventricular ejection fraction \< 30% * myocardial infarction, unstable angina, percutaneous coronary intervention, coronary artery bypass graft or stroke within 3 months of randomization, planned cardiac surgery or revascularization, uncontrolled cardiac arrhythmia * liver transplant history. * uncontrolled hypertension. * moderate to severe renal dysfunction. * active liver disease or hepatic dysfunction. * known sensitivity to any of the products to be administered during dosing
safety and feasibility of exablate neuro system to perform auto-focusing echo imaging in patients with essential tremor

Conditions: Tremor, Essential; Neurologic Manifestations; Tremor

Summary: the objective of this study is to evaluate the safety and feasibility of auto focusing (af) echo imaging using the exablate neuro system

this clinical investigation is a feasibility study designed to evaluate the safety and feasibility of the exablate neuro system to perform af echo imaging in patients diagnosed with idiopathic essential tremor. during the standard care procedure for et, patients will be injected with definity microbubbles which will enable the exablate neuro system to perform the af imaging.

Eligibility criteria:
inclusion criteria: 1. male or female age 22 years or older 2. able and willing to give consent and able to attend all study visits 3. a confirmed diagnosis of essential tremor resistant to medication therapy 4. able to fit into mri unit 5. able to tolerate the procedure with or without some form of sedation 6. able to communicate sensations during the exablate mrgfus procedure 7. able to activate stop sonication button during the exablate mrgfus procedure exclusion criteria: 1. presence of unknown or mri unsafe devices anywhere in the body. 2. patients with known intolerance or allergies to the mri contrast agents 3. women who are pregnant 4. patients with advanced kidney disease or on dialysis 5. significant cardiac disease or unstable hemodynamic status 6. patients exhibiting any behavior(s) consistent with ethanol or substance abuse 7. history of a bleeding disorder 8. patients receiving anticoagulant or drugs known to increase risk of hemorrhage 9. patients with cerebrovascular disease 10. patients with brain tumors 11. individuals who are not able or unwilling to tolerate the required prolonged stationary position during treatment (approximately 2-3 hours) 12. patients who are currently participating in another clinical investigation 13. patients unable to communicate with the investigator and staff 14. patients who have cardiac shunts 15. patients with relative contraindications to definity ultrasound contrast agent including subjects with a family or personal history of arrhythmia's 16. patients with chronic pulmonary disorders 17. patients with a history of drug allergies, uncontrolled asthma or hay fever 18. patients who have had deep brain stimulation or a prior neuroablative procedure 19. women who are pregnant or nursing 20. patients who have been administered botulinum toxins into the arm, neck, or face for 5 months prior to enrollment in the study.

Keywords: mrgfus exablate essential tremor auto-focusing echo imaging
ultrasound-guided landmark and epidural site pain

Conditions: Back Pain; Epidural Analgesia, Obstetric

Summary: historically, women who have chronic back pain after pregnancy have attributed the cause to the epidural procedure. while many studies have shown no greater incidence of generalized post-partum back pain in those who received an epidural, no studies have measured localized pressure sensitivity at the epidural insertion site. short-term pressure sensitivity might limit patient's mobility and activities in the post-partum period. understanding the factors that increase insertion site pressure sensitivity will allow the investigators to modify epidural placement technique in order to minimize this effect.

few studies have examined how epidural placement changes localized sensation at the epidural insertion site. this study will be the first study to quantitatively measure sensation at the epidural insertion site. the investigator will assess localized pressure sensitivity with an algometer. an algometer is a hand-held device commonly used by neurologist to detect sensory deficits and measures the pressure sensitivity threshold in a 1-cm diameter circular area. ultrasound (us) pre-procedural examination provides more accurate landmarks for the placement of epidural catheters. the investigator will determine if an us examination prior to epidural placement reduces localized pressure sensitivity. the investigator will also determine if there are correlations between the participants characteristics and/or comorbidities and increased pressure sensitivity at the insertion site.

Eligibility criteria:
inclusion criteria: * pregnant with term (37 - 41 weeks) singleton gestation * active labor * history of normal pregnancy * request an epidural * age between 18 - 35 years old * able to understand the protocol and provide voluntary, written, informed consent. exclusion criteria: * history of spinal surgery * scoliosis * epidural or spinal placement within the last 5 days * neuropathic pain disorders * chronic opioid use * texas department of criminal justice patient * placental percreta * placental increta * placenta accreta * preeclampsia * eclampsia

Keywords: acute pain ultrasonography
vapocoolant spray to reduce pain with nexplanon insertion

Conditions: Reducing Pain With Nexplanon Implant Insertion

Summary: the purpose of this study is to assess if pain ease vapocoolant spray decreases pain associated with lidocaine injection during nexplanon insertion procedures.

this study will be for patients in the office having a nexplanon (etonogestrel implant) insertion. the doctor in clinic will evaluate if a patient meets eligibility criteria for this study. if the patient meets eligibility criteria, the doctor will inform the patient of the study and the potential risks. if patients elect to participate, a research coordinator will obtain written informed consent. the patient will be randomized (patient is blinded) to receive either pain ease vapocoolant spray or placebo (normal saline) spray. they will receive the spray just before lidocaine injection during the nexplanon insertion procedure. the purpose of the study is to see if pain ease vapocoolant spray reduces patient pain during lidocaine injection for nexplanon insertion.

Eligibility criteria:
inclusion criteria: * at least 14 years or older * undergoing an etonogestrel implant insertion in the arm in pob1 suite 1004 or pob2 suite 402 * english speaking * able and willing to sign the informed consent form and agree to terms of the study exclusion criteria: * required or requested narcotics, anxiolytics, iv sedation, or general anesthesia for the procedure * known previous exposure to vapocoolant spray * nexplanon removal and reinsertion in same visit * contraindications to vapocoolant spray components (ethyl chloride and 1,1,1,3,3-pentafluoropropane/1,1,1,2-tetrafluroethane) * unable to provide written, informed consent in english

Keywords: vapocoolant spray pain with nexplanon insertion contraceptive implant insertion vapocoolant
adult congenital heart disease international evaluation of the effectiveness of sglt2i registry

Conditions: Adult Congenital Heart Disease; Congenital Heart Disease; Systemic Right Ventricle; Transposition of the Great Arteries; Congenitally Corrected Transposition of the Great Arteries; Fontan; Single Ventricle; Tetralogy of Fallot (TOF)

Summary: this real-world, international registry aims to evaluate the current experience with sodium-glucose cotransporter 2 inhibitors (sglt2i) in adult congenital heart disease (achd) patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes.

in the adult congenital heart disease (achd) population, heart failure currently represents the main cause of morbidity and mortality. the etiology of achd-related heart failure is heterogenous, and there is limited evidence for pharmacological treatment options for this population. sodium-glucose cotransporter 2 inhibitors (sglt2i) are a novel pillar in the treatment of conventional lv heart failure. sglt2i have been shown to reduce the risk of worsening heart failure and cardiovascular-related death in patients with lv heart failure. while the exact mechanisms of action are still to be elucidated, sglt2i seem to address heart failure by targeting several pathways. these include but are not limited to; a decrease in renin-angiotensin and sympathetic nervous system activation, a decrease in pressure overload-induced myocardial fibrosis, reverse cardiac remodeling, and improvement in myocardial energetics. given the compelling evidence on the effectiveness of sglt2i over a broad range of cardiac dysfunction and initial promising reports of its utilization in the field of achd, sglt2i deserve further exploration in the group of achd patients. this real-world, international registry aims to evaluate the current experience with sglt2i in achd patients by investigating the prescription patterns, safety, tolerability, and potential beneficial effects on heart failure-related outcomes. project design: data of all achd patients who were started on an sglt2i will be collected in a real-world, international registry. only data resulting from routine clinical care will be collected from the electronic health records at the participating centers, and participants will not undergo any interventions for this project. data will be collected from 1 year before starting with the sglt2i to most recent follow-up after starting with the sglt2i, to evaluate if sglt2i therapy halts the progression of clinical deterioration in achd patients with heart failure and can improve heart failure-related outcomes.

Eligibility criteria:
inclusion criteria: * congenital heart defect. * age ≥ 18 years. * initiated on treatment with an sglt2i. exclusion criteria: - no consent for data collection.

Keywords: adult congenital heart disease achd congenital heart disease chd sodium-glucose cotransporter 2 inhibitors sglt2i sglt2 heart failure hf transposition of the great arteries tga systemic right ventricle srv fontan single ventricle tetralogy of fallot tof
study to evaluate the safety and efficacy of sirolimus, in subject with refractory solid tumors

Conditions: Refractory Solid Tumors

Summary: this study is a single arm, pilot study of sirolimus in patient with phosphatidylinositide-3-kinase (pik3ca) mutation, pik3ca amplification , pik3ca-akt pathway aberration refractory solid tumor and/or specific sensitivity to mtor inhibitors by avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. sirolimus 1mg will be administered orally daily. to investigate the efficacy and safety of sirolimus in patient with refractory solid tumor.


Eligibility criteria:
inclusion criteria: * provision of fully informed consent prior to study specific procedures. * patients must be \>= 19 years of age * phosphatidylinositide-3-kinase (pik3ca) mutation, pik3ca amplification , pik3ca-akt pathway aberration( h1047r, e542k, e545k, pten loss) refractory solid tumor and/or specific sensitivity to mtor inhibitors by avatar scan that has progressed following standard therapy or that has not responded to standard therapy or for which there is no standard therapy. * ecog performance status0-2 * have measurable or evaluated disease based on recist 1.1 as determined by investigator. * adequate organ function laboratory values * absolute neutrophil count \>= 1.5 x 109/l, hemoglobin \>= 9g/dl, platelets\>=75 x 109/l bilirubin \<= 1.5 x upper limit of normal ast/alt \<= 2.5 x upper limit of normal(5.0 x upper limit of normal, for subject with liver metastases) creatinine\<= 1.5 x unl * patients of child-bearing potential should be using adequate contraceptive measures should not be breast feeding and must have a negative pregnancy test prior to start of dosing * adequate heart function exclusion criteria: * patients with second primary cancer, except:adequately treated non-melanoma skin cancer, curatively treated in-situ cancer of the cervix, or other solid tumor curatively treated with no evidence of disease for \<= 5 years. * has known active central nervous system(cns) metastases * has an active infection requiring systemic therapy * pregnancy or breast feeding * patients with cardiac problem * any previous treatment with sirolimus
evaluation of stem cell therapy effects on the immune response in rheumatoid arthritis patients

Conditions: Rheumatoid Arthritis

Summary: 1. objectives: evaluation of mesenchymal stem cell therapy effects on cellular and humoral immune responses in refractory rheumatoid arthritis (ra) patients. 2. design: this study has been performed as a phase 1 clinical trial. 3. setting and conduct: autologous bone marrow derived mesenchymal stem cells were obtained by bone marrow aspiration and cultured in minimum essential medium-alpha (mem-alpha) for 4 weeks in standard clean room and then transfused to ra patients intravenously. 4. participant's major eligibility criteria is as follows: ten refractory rheumatoid arthritis patients who show resistance to non biological disease-modifying antirheumatic drugs (dmards) after 6 to 12 months have been enrolled in this study. 5. intervention: a single dose of intravenous autologous bone marrow derived mesenchymal stem cells have been administered into patients with resistance to non-biological dmards. 6. main outcome measures (variables): finding of mesenchymal stem cell therapy effects on the cellular and humoral immune responses and evaluation of the effect of chemokines in homing of immune cells following the intervention.

refractory rheumatoid arthritis patients who met the inclusion/exclusion criteria have been selected. after signing informed consent form, autologous stem cells were obtained by bone marrow aspiration. isolation and culture (3 to 4 weeks in mem-alpha medium) of mesenchymal stem cells (mscs) were performed in accredited good manufacturing practices (gmp) clean room. a panel of cluster of differentiation (cd) markers including cd105, cd166, cd44, cd45, cd90, and cd34 were checked for making sure about differentiation of cells into mscs after 3-4 weeks of cell culture. viability of mscs was checked by trypan blue testing and all of the cultivations were negative for bacterial contamination. a single dose of 1000000 to 2000000 mesenchymal stem cells/kg infused into patients intravenously. to prevent anaphylactic reactions, a single intravenous dose of hydrocortison (100 ml) and oral dimenhydrinate (10 ml) were administered before mscs infusion into patients. the effects of mesenchymal stem cells on the cellular and humoral immune responses and also the role of chemokines in homing of immune cells were studied at time points 1, 6 and 12 months after intravenous administration of mscs in refractory rheumatoid arthritis.

Eligibility criteria:
inclusion criteria: * resistant ra patients to non-biological dmards; * treated ra patients by non-biological drugs; * treated ra patients by prednisolone, hydroxychloroquine, sulfasalazine and methotrexate; * patients age between 35-60 years; * refractory ra patients with no other rheumatologic disorders and inflammatory diseases. exclusion criteria: * non-resistant ra patients to non-biological dmards.

Keywords: rheumatoid arthritis stem cells cellular immunity humoral immunity chemokines homing of immune cells
covid-19 study of pharmacokinetics, safety, tolerability, and efficacy of intravenous anti-spike(s) sars-cov-2 monoclonal antibodies (casirivimab+imdevimab) for the treatment of pediatric patients hospitalized due to covid-19

Conditions: COVID-19

Summary: the primary objectives of the study are: * to characterize the concentrations of casirivimab+imdevimab in serum over time * to evaluate the safety and tolerability of casirivimab+imdevimab the secondary objective of the study is: • to assess the immunogenicity of casirivimab+imdevimab


Eligibility criteria:
key inclusion criteria: 1. has sars-cov-2 positive antigen or molecular diagnostic test ≤72 hours prior to study enrollment note: historical record of positive result is acceptable as long as the sample was collected ≤72 hours prior to enrollment 2. has symptoms consistent with covid-19, as determined by the investigator, with onset ≤ 14 days before dosing 3. hospitalized due to covid-19 4. provide informed consent signed by study patient or legally acceptable representative/guardian key exclusion criteria: 1. in the opinion of the investigator, unlikely to survive for \>96 hours from screening 2. neonates having gestational age of \<29 weeks and weight \<1.1 kg 3. receiving extracorporeal membrane oxygenation (ecmo) 4. has new-onset stroke or seizure disorder during hospitalization 5. initiated on renal replacement therapy due to covid-19 6. has circulatory shock requiring vasopressors on dosing day note: patients who require vasopressors for sedation-related hypotension or reasons other than circulatory shock may be eligible in this study 7. participation in a clinical research study, including any double-blind study, evaluating an investigational product within 30 days and less than 5 half-lives of the investigational product prior to the screening visit 8. members of the clinical site study team and/or their immediate family 9. plans to receive an investigational or approved sars-cov-2 vaccine within 90 days after study drug administration based on current centers for disease control vaccination guidelines (cdc, 2021). refer to the latest cdc guidance for any updates. note: patients who have already completed vaccination prior to study enrollment may be allowed in the study. 10. prior use (within 90 days prior to study drug administration) or current use of any investigational, authorized, or approved passive antibody for prophylaxis of sars-cov-2 infection, including convalescent plasma, convalescent sera, hyperimmune globulin, or other monoclonal antibodies (eg, bamlanivimab and etesevimab, sotrovimab) note: other protocol defined inclusion/ exclusion criteria apply

Keywords: coronavirus disease 2019 (covid-19) severe acute respiratory syndrome coronavirus 2 (sars-cov-2) coronavirus
refeeding syndrome in cancer patients

Conditions: Refeeding Syndrome; Cancer; Critical Illness

Summary: the purpose of this study is to evaluate whether a nutritional strategy is effective in critically ill patients with cancer diagnosed with refeeding syndrome.

refeeding syndrome is a clinical entity triggered by the introduction of calories in chronically undernourished patients. a number of organs may be affected due to imbalance of fluids and electrolytes. in the intensive care setting, there are no formal guidelines to recommend the appropriate treatment of this condition. the aim of this study is to evaluate the implementation of a nutritional protocol to address cancer patients admitted to the icu with refeeding syndrome.

Eligibility criteria:
inclusion criteria: * initiation of any type of nutrition (enteral, parenteral or glucose solution of at least 10% concentration) in the icu in the last 48 hours; * reduction of serum phosphorus to a level below 2.5mg/dl with a drop above 0.5mg/dl compared to a previous measurement; * caloric intake greater than 500kcal in the last 24 hours; * central venous access for electrolyte replacement; * signature of the informed consent form. exclusion criteria: * use of enteral or parenteral nutrition before icu admission; * prediction of icu discharge in the following 2 days; * end-stage renal disease; * admission for diabetic ketoacidosis or hyperosmolar hyperglycemic state; * recent treatment of hyperphosphatemia; * parathyroidectomy surgery; * participation in another study; * refusal to participate in the study.

Keywords: refeeding syndrome cancer