Kornimate/medical-research-clean huggingface dataset:
hokt3gamma1 (ala-ala) for the prevention of human islet allograft failure

Conditions: Diabetes Mellitus, Insulin-Dependent; Diabetes Mellitus, Experimental; Transplantation, Homologous; Islets of Langerhans Transplantation

Summary: the broad, long-term goal of this proposal is to improve the results and applicability of islet allotransplantation early in the course of type 1 diabetes through the administration of selective and short-term immunotherapy. more specifically, the objectives of these studies is to conduct an open-labeled, one-year follow-up phase i/ii study in patients with surgical and type 1 diabetes to determine the safety, tolerability, immune activity, and pharmacokinetics of hokt3gamma1 (ala-ala) administration for the prevention of autoimmune destruction and rejection of allogeneic islet transplants.

adverse events will be monitored and recorded throughout the first year post-transplant. the proportion of surgical and type 1 diabetic subjects receiving an islet allotransplant who achieve and maintain full or partial islet graft function during the first year post-transplant will be determined to assess the efficacy of hokt3gamma1 (ala-ala) administration. successful completion of the proposed clinical trial will increase our understanding of the safety, efficacy and underlying mechanisms of selective immunotherapy with the anti-cd3 monoclonal antibody hokt3gamma1 (ala-ala) for the maximization of engraftment and functional survival of allogeneic human islets in surgical and type 1 diabetic recipients.

Eligibility criteria:
inclusion: * primary islet allotransplant * surgical or type 1 diabetes mellitus, complicated by signs and symptoms that persist despite intensive efforts made in close cooperation with their diabetes care team * age 18 or older * must give written informed consent
relationship between endothelial progenitor cells and revascularization effect of moyamoya disease

Conditions: Moyamoya Disease

Summary: moyamoya disease is a chronic cerebrovascular disease，the typical pathological manifestations are the stenosis or occlusion of the distal internal carotid artery and/or middle cerebral artery, and the proximal anterior cerebral artery. meanwhile, the abnormal vascular net, which is the smokey vessel, occurs at the bottom of the brain. currently the pathogenesis of this disease is unknown. limited studies have reported the expression of endothelial progenitor cells (epcs) in moyamoya disease, but the results were inconsistent. some investigators believe that the number of epcs in peripheral blood of patients with moyamoya disease is increased, while others believe that the number of epcs in peripheral blood of moyamoya patients is reduced. therefore, the investigators need to find a more accurate detection method to confirm the growth of epc in patients with moyamoya disease. at the same time, whether there is endothelial injury in patients with smoke disease, and the expression of endothelial cells (cec) in patients with smoke disease, there is no research on this aspect at home and abroad.

objective: detect the expression of endothelial progenitor cells and endothelial cells from peripheral blood of patients with moyamoya disease, and to assess the relationship between clinical characteristics. design: a single center study, and planned to enroll 120 patients. the present study was to detect the quantities of epc from peripheral blood in moyamoya disease by flow cytometry, and to identify the relationship of endothelial progeilitor cells and effect of the revascularization on moyamoya disease. the present study also use cerebral ischemia animal model foe intervention experiment, to explore whether epc can promote vascular remodeling effect of ischemic cerebrovascular disease, and to provide new thought for the treatment of chronic cerebrovascular disorder.

Eligibility criteria:
inclusion criteria: 1. whole-brain vessels angiography or magnetic resonance arteriography (mra) has the following manifestations: stenosis or occlusion of terminal internal carotid artery or the anterior cerebral artery and/or initiating middle cerebral artery; in the arterial phase, the abnormal smokey vascular net near the occlusive or stenosis lesion can be seen. 2. for patients with stable stroke, there was no acute or subacute cerebral infarction or cerebral hemorrhage, and at least 3 months before the last cerebral infarction or cerebral hemorrhage events. exclusion criteria: 1. exclude atherosclerosis, autoimmune diseases, meningitis, intracranial tumors, multiple neurofibromatosis, down syndrome, craniocerebral trauma, radiation injury, and other underlying diseases that may cause smoke. 2. acute or subacute cerebral infarction or cerebral hemorrhage were excluded.

Keywords: moyamoya disease endothelial progenitor cells revascularization
building and sustaining exercise habits for adults with type 1 diabetes

Conditions: Type 1 Diabetes (T1D); Latent Autoimmune Diabetes in Adult (LADA); Pancreatitis

Summary: the challenges of living with type 1 diabetes often stand in the way of getting enough exercise. continuous blood sugar monitoring has revolutionized type 1 diabetes care but remains underutilized to sustainably support exercise and related behaviors. this research will develop a mobile application that delivers personalized encouragement and data-driven health insights based upon patterns in blood sugar, exercise, mood, and sleep, to assist people with type 1 diabetes in exercising more frequently and confidently.


Eligibility criteria:
inclusion criteria: * 30-65 years old inclusive * diagnosis with type 1 diabetes (t1d) or other insulin deficiency diabetes (latent autoimmune disease of adulthood, diabetes secondary to pancreatitis) * less than 1.0 exercise sessions per week * smartphone ownership * english literacy * under regular care by a healthcare provider (1+ appointments per year) * home broadband wireless internet or cell phone network * using continuous glucose monitor (cgm) and sharing data with medical record for at least 6 weeks * using insulin pump or pen and sharing data with medical record for at least 6 weeks exclusion criteria: * diabetic ketoacidosis not clearly related to pump site failure in past 6 months * \>1 episode of severe hypoglycemia (altered mental and/or physical status requiring assistance from another person for recovery) in past 6 months * a1c ≥10.0% * resting blood pressure \>160mmhg systolic or \>100 mmhg diastolic. * myocardial infarction or angina in past 12 months * uncontrolled arrhythmia (e.g., atrial fibrillation with rapid ventricular response, new onset atrial fibrillation, ventricular tachycardia, escape rhythms) * congestive heart failure (stage 3 or 4) * exercise-induced asthma (not controlled on inhalers) * chronic obstructive pulmonary disease (requiring home oxygen) * renal failure * pregnancy * cognitive impairment * severe retinopathy or neuropathy. * other chronic disease or physical disability that would influence exercise intervention (e.g., recent spinal surgery)

Keywords: exercise physical activity mobile phone health coaching fitness watch
cabergoline effect on blood sugar in type 2 diabetics

Conditions: Diabetes Type 2

Summary: diabetic patients with poorly control blood sugar are prescribed cabergoline for 1 months and their blood glucose is evaluated.


Eligibility criteria:
inclusion criteria: * type 2 diabetes * hba1c\>7 exclusion criteria: * hba1c\>10 * psychiatric disorders

Keywords: diabetes mellitus fbs hba1c cabergoline
inflammation and acute coronary syndromes

Conditions: Acute Coronary Syndromes

Summary: subproject 1: optimize prevention after acute coronary syndromes (acs) by improving caregiver and patient education (http://elips.hug-ge.ch/eng/index_eng2.htm) subproject 2: discover novel genomic biomarkers of acs in leukocyte subsets by means of analyzing gene expression profiles and function subproject 3: evaluate novel diagnostic and prognostic biomarkers in soluble form in blood/plasma and urine subproject 5: visualize the vulnerable plaque using intravascular ultrasound/optical coherence tomography (ivus/oct) and correlate with outcome and biomarkers subproject 7: characterize the effects of inflammation on progenitor/stem cell-mediated repair after acs by means of analyzing gene expression profiles and function


Eligibility criteria:
inclusion criteria: * all patients with age ≥ 18 years presenting within 5 days (preferably within 72 hours) after pain onset with the main diagnosis of acs (acute myocardial infarction: stemi /nstemi and threatened infarction: unstable angina pectoris), who enter the hospital: the patients show symptoms, which are compatible with angina pectoris (chest pain, dyspnoea) and at least one of the following characteristics: * persistent st-segment elevation or depression, t inversion or dynamic ecg changes, new left bundle branch block (lbbb) * evidence of positive troponin by local laboratory reference values with a rise and/or fall in serial troponin levels * known coronary artery disease, specified as status after myocardial infarction, cabg, or pci or newly documented ≥50% stenosis of an epicardial coronary artery during the initial catheterization exclusion criteria: * severe physical disability, * dementia (inability to comprehend study), or * less than 1 year of life expectancy (for non-cardiac reasons).

Keywords: inflammation acs prevention education clinical management
the use of nesiritide in thoracic aneurysm repair to prevent acute renal failure

Conditions: Cardiovascular Disease; Acute Renal Failure; Death

Summary: the purpose of this trial is to study the use of nesiritide in thoracic aneurysm repair to prevent acute renal failure. the study hypothesis: nesiritide, given prophylactically prior to surgery may prevent acute renal failure requiring dialysis and/or decrease mortality.

acute renal failure is a major and serious complication of more than 200,000 cardiovascular surgeries performed on adult americans annually (www.sts.org). the incidence of acute renal failure (arf) after cardiac surgery (depending on criteria used to define arf) is 1-5%, in the absence of preexisting renal dysfunction. the subset of patients with thoracic aortic aneurysm surgery have a higher risk for the development of postoperative arf (25-40% - arf defined as doubling of serum creatinine; 13% - arf defined as requirement for dialysis). this risk is further increased by various peri-operative factors, especially cardiopulmonary bypass time. the overall postoperative mortality rate for cardiovascular surgery is 2.2%, but is much higher for thoracic aortic aneurysm surgery (8-10% for elective repair, 25-50% for ruptured thoracic aorta aneurysm repair). the major risk factor for thoracic aortic aneurysm surgery related mortality is post-operative arf requiring dialysis. when thoracic aortic aneurysm surgery is complicated by acute renal failure, the mortality rate worsens to 50%. thus, identifying ways to prevent acute renal failure may have a major impact on the outcome of cardiovascular surgery. a retrospective study of the use of nesiritide in cardiovascular surgery patients by our group has demonstrated a tendency towards a decreased incidence of renal failure and mortality, when the medication is used prophylactically.

Eligibility criteria:
inclusion criteria: * age 18 years or older * undergoing thoracic aortic aneurysm surgery * impaired renal function exclusion criteria: * prior history of allergy/adverse reaction to nesiritide * history of any organ transplant * preoperative intra-aortic balloon pump (iabp) * decompensated congestive heart failure (chf)

Keywords: acute renal failure nesiritide cardiovascular surgery
efficiency and safety of pleural biopsy methods in the diagnosis of pleural diseases

Conditions: Diagnosis of Pleural Diseases; Medical Thoracoscopy

Summary: image-guided pleural biopsies, both ultrasound (us) or computed tomography (ct) guided, and medical thoracoscopy are important in the diagnosis of pleural disease. however, no consensus exists regarding which biopsy methods are appropriate for specific procedures. in this prospective study, the investigators aimed to compare ct-scan guided pleural biopsy using an abrams' needle (ct-anpb) with us-assisted pleural biopsy using a cutting needle (us-cnpb)and medical thoracoscopy with respect to both diagnostic yield and safety.

the primary end point of this study was the determination of the sensitivity and the complication rates of the invasive methods, abrams needle pleural biopsy, tru-cut needle pleural biopsy, medical thoracoscopy with respect to the diagnosis of pleural disease.

Eligibility criteria:
inclusion criteria: * patients with pleural diseases exclusion criteria: * patients with other lung diseases
effect of antiplatelet therapy on cognition after aneurysmal subarachnoid hemorrhage

Conditions: Aneurysmal Subarachnoid Hemorrhage

Summary: deficits in memory, executive function, and language are common cognitive sequelae of aneurysmal subarachnoid hemorrhage (asah). previous study demonstrated that post-treatment antiplatelet therapy reduced risk for delayed cerebral ischemia caused by asah. however, the effect of antiplatelet therapy on cognition after asah is unclear. the aim of this study was to assess the effect of antiplatelet therapy on cognition after asah.


Eligibility criteria:
inclusion criteria: * 1. patients with sah in whom the aneurysm was proven by conventional angiography; 2. baseline hunt-hess grade i-iii; 3. patients received endovascular treatment exclusion criteria: * 1. hunt-hess grade iv-v; 2. non-aneurysmal sah; 3. dementia in other diseases; 4. lacking of 6-8 month moca evaluation.
study of salirasib to treat non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the purpose of this study is to determine whether salirasib is effective to shrink or prevent the growth of the tumors associated with non-small cell lung cancer in both patients who are newly diagnosed or have recurrent disease.


Eligibility criteria:
inclusion criteria: * age 18 or older * non-small cell lung cancer not amenable to curative therapy with surgery or radiation * measurable disease * adenocarinoma of the lung, have not received prior chemotherapy for the malignancy and has a ≥ 15 pack year history of smoking; or previously treated with recurrent disease and documented kras mutation * last dose of radiotherapy \> 3 weeks prior to study entry and recovered from all acute toxicities associated with the prior therapy * no history of another malignancy in the past 5 years except treated non-melanomatous skin cancer or superficial bladder cancer or carcinoma-in-situ of the cervix * karnofsky performance status of 70 or greater * body weight \> 50 kg * life expectancy ≥ 3 months * serum creatinine ≤2.0 mg/dl, total bilirubin ≤ 2.0 mg/dl, alt and ast ≤ 3x uln, alkaline phosphatase ≤ 5x uln, wbc \> 3000/mm³, anc ≥ 1500/mm³, platelets ≥ 100,000/mm³, hemoglobin ≥ 10g/dl. * no coexisting cardiac or medical problems that would limit compliance in the study * willing to undergo blood sampling for pharmacokinetic analysis * negative pregnancy test, if applicable exclusion criteria: * evidence of active heart disease including myocardial infarction within previous 3 months * active infectious process * active central nervous system metastases (requiring increasing doses of corticosteroids over the prior month, known progressing lesions) * pregnant or lactating * major surgery without full recovery or major surgery within 3 weeks prior to treatment start * qtc interval \> 470 msec * gastrointestinal tract disease resulting in inability to take or absorb oral medications

Keywords: non-small-cell lung
heated humidified high flow nasal cannula oxygen in obstructive sleep apnea in adolescents

Conditions: Obesity; Obstructive Sleep Apnea (Moderate to Severe); Central Sleep Apnea

Summary: the research study is being done to test heated humidified high-flow air (hhf), as a treatment for osa.


Eligibility criteria:
obese subjects: inclusion criteria: * obesity, defined as a bmi \> 95th percentile for age and gender * age 10 through 18 years * informed consent with assent in accordance with the institutional policies (institutional irb approval) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study * moderate-severe osa or central sleep apnea (csa) as defined by oahi or cahi exclusion criteria: * patients with other neurological problems, including but not limited to neurocutaneous disorders such as neurofibromatosis or tuberous sclerosis * obesity due to other diseases and syndromes (e.g. prader-willi syndrome) * pregnancy * currently unwell, hospitalized or recent viral/bacterial infection in the previous 4 weeks * adenoidal and/or tonsillar hypertrophy which may be amenable to surgical intervention to help alleviate osa * patients with severe respiratory distress * patients with increased risk of pneumothorax including but not limited to previous pneumothorax, bronchiectasis or severe untreated asthma. children with medical complexity subjects: inclusion criteria: * cmc recently diagnosed with moderate to severe osa or csa requiring cpap therapy * 0-18 years of age * informed consent with assent in accordance with the institutional policies (institutional irb approval) must be signed by the patient's legally authorized guardian acknowledging written consent to join the study exclusion criteria: * current upper respiratory tract infection * subjects who are receiving oxygen therapy
silicone gel vs. estrogen vaginal cream for the management of genitourinary syndrome of menopause

Conditions: Genitourinary Syndrome of Menopause

Summary: the goal of this randomized controlled trial is to test the efficacy of stratamgt in the management of genitourinary syndrome of menopause (gsm) compared to estrogen therapy. the main question it aims to answer is: - will stratamgt be non-inferior regarding patient quality of life compared to standard of care? participants will use either stratamgt or estrogen vaginal cream to treat gsm for 3 consecutive months. after the baseline assessment, participants will be assessed monthly for quality of life, clinical signs, symptoms, pathology and adverse reactions.


Eligibility criteria:
inclusion criteria: * able to provide informed consent * confirmed postmenopausal age * diagnosed genitourinary syndrome of menopause * access to a smartphone, tablet or computer, and to a functional email address. exclusion criteria: * contraindication for the use of estrogen therapy * unable to provide informed consent * patient unable to apply topical device * allergy or intolerance to ingredients or excipients of the formulation of studied products
lead-in study to collect prospective efficacy and safety data of current fviii prophylaxis replacement therapy in adult hemophilia a participants

Conditions: Blood Coagulation Disorder; Blood Coagulation Disorders, Inherited; Coagulation Protein Disorders; Hemophilia A; Genetic Diseases, Inborn; Genetic Diseases, X-Linked; Hematologic Diseases; Hemorrhagic Disorders; Factor VIII Deficiency

Summary: the aim of this prospective, observational study is to establish a dataset on the frequency of bleeding events, as well as other characteristics of bleeding events and fviii infusions, in patients with clinically severe hemophilia a receiving prophylactic fviii replacement therapy as standard of care. the data collected from this study may assist in providing baseline information for comparison to the spark's investigational hemophilia a gene therapy in future phase 3 studies.


Eligibility criteria:
inclusion criteria: 1. able and willing to provide written informed consent. 2. males ≥18 years of age. 3. clinically severe hemophilia a 4. previous exposure to fviii therapy 5. no prior history of hypersensitivity or anaphylaxis associated with an fviii or intravenous immunoglobulin administration. 6. no measurable inhibitor against fviii 7. willing to participate and receive treatment in a future spark hemophilia a gene therapy study. exclusion criteria: 1. documented active hepatitis b or c within the past 12 months of screening 2. currently on antiviral therapy to treat hepatitis b or c; 3. documented significant liver disease within the past 6 months of screening 4. have serological evidence of hiv-1 or hiv-2 5. anti-aav-spark 200 neutralizing titers ≥1:1 6. previously received spk-8011; 7. previously dosed with any investigational or approved gene therapy product at any time or treated with an investigational drug within the last 12 weeks; 8. planned surgical procedure in the next 12 months requiring fviii prophylactic treatment. 9. any history of chronic infection or other chronic disease, concurrent clinically significant major disease (such as liver abnormalities or type i diabetes) including active malignancy, except for non-melanoma skin cancer, any other condition or any other unspecified reasons that, in opinion of the investigator or sponsor, makes the participant unsuitable for participation and dosing in a future clinical study for spark's hemophilia a gene therapy. 10. unable or unwilling to comply with the schedule of visits and/or study assessments described in the protocol.

Keywords: factor viii factor viii protein recombinant
the effect of subcutaneous immunoglobulin gammanorm on the distribution of igg subclasses and on immunity of patients with secondary immunodeficiency

Conditions: Secondary Immune Deficiency

Summary: patients with myeloma or cll with severe secondary hypogammaglobinemia and recurrent infections will be included in this study; for whom an igsc treatment was prescribed. the igsc prescription will be the decision of the treating physician. patient care and follow up will be performed according to the current clinical practice and the recommendations of has.


Eligibility criteria:
inclusion criteria: 1. adult male or female (≥18 years old), myeloma or chronic lymphocytic leukemia patients with secondary hypogammaglobinemia and recurring infections. 2. patients with indication for igsc treatment but who have not started the treatment yet. prior igsc or igiv treatment 6 months before inclusion is accepted (with a washout period of 6 months minimum). 3. patient having received all the necessary information about the study and signed an informed consent document. exclusion criteria: 1. patient having initiated an igsc treatment. 2. patient having received igsc or igiv treatment within 6 months prior to inclusion. 3. incapacity/inability to attend the follow-up visits. 4. patient refusing to participate in the study. 5. hiv positive patients. 6. incapacity to understand the study objective and process, to agree or to give informed consent to participate in the study. 7. pregnant or breast-feeding women