Kornimate/medical-research-clean huggingface dataset:
savvywire™ efficacy and safety in transcatheter aortic valve implantation procedures (safe-tavi)

Conditions: Severe Aortic Stenosis

Summary: the purpose of the clinical investigation is to determine efficacy and safety of using the rapid pacing of savvywire™ during tavi procedures.


Eligibility criteria:
inclusion criteria: 1. subject is at least 18 years old 2. subject has a severe symptomatic as undergoing a tavi procedure 3. subject with a thv for which rapid pacing is considered necessary during valve implantation 4. subject agrees to participate in the study and is able to sign the informed consent form exclusion criteria: 1. failure to provide signed informed consent 2. extremely horizontal aorta (aortic root angle ≥70°) 3. extreme tortuosity at the level of the iliofemoral arteries, thoracic or abdominal aorta 4. inability to receive full anticoagulation during the tavi procedure 5. prohibitive surgical risk precluding (according to the heart team) conversion to open heart surgery in case of a life-threatening complication.
feasibility trial of a lifestyle intervention for chr-p

Conditions: Prodromal Schizophrenia; Psychosis; Psychological Disorder; Psychological Stress

Summary: the present study will assess the feasibility and social validity of an adjunctive health promotion group for youth and clinical high risk for psychosis (chr-p). youth participating in treatment at the center for the assessment and prevention of prodromal sates (capps) will be invited to participate in a weekly, adjunctive, closed psychoeducation group focused on sharing health promotion strategies and increasing health behaviors (e.g. improved sleep habits, increased participation in physical activity). the aim of the group will be to provide psychoeducation on lifestyle risk and protective factors for youth at risk for psychosis (i.e. experiencing subthreshold psychosis symptoms). topics covered will include psychoeducation, goal setting, stress management, sleep, physical activity, substance use, and nutrition. evidence-based strategies to decrease risk factors and promote protective lifestyle factors for mental illness will be reviewed. group leaders will utilize a motivational interviewing approach to facilitate the group. the group will complete nine weekly group sessions. the goal of our research is to 1) determine the feasibility of a novel group-based health promotion intervention, 2) assess the social validity of the group, 3) measure the effects of the intervention on stress, sleep, physical activity, substance use, and nutrition, and 4) measure preliminary effects on symptoms and functioning.


Eligibility criteria:
inclusion criteria: 1. between 13 and 17 years old 2. able to sign and provide informed consent (assent for minors) 3. meet criteria for chr-p using the structured interview for psychosis-risk syndromes (sips). 4. must have a primary caregiver willing to participate who speaks fluent english exclusion criteria: 1. current or lifetime dsm-5 psychotic disorder 2. impaired intellectual functioning (iq \<65) 3. history of neurological disorder 4. traumatic brain injury (≥7 on tbi screening tool) 5. significant substance use that makes chr-p diagnosis ambiguous

Keywords: early intervention lifestyle intervention clinical high risk for psychosis health behavior
a pilot study to assess the efficacy and safety of lcq908 alone and in combination with fenofibrate or lovaza® in patients with severe hypertriglyceridemia

Conditions: Non Familial Chylocmicronemia Syndrome (Non-FCS)

Summary: this study is to determine a dose response signal for lcq908 monotherapy and to assess the efficacy and safety of adding lcq908 to lovaza or fenofibrate.


Eligibility criteria:
inclusion criteria: * male and female subjects ages \>18 years of age, inclusive. * history of plasma tg concentration ≥890 mg/dl (10 mmol/l) or history of lactescent plasma in the fasting state. * fasting tg ≥ 750 mg/dl (8.5 mmol/l) at day -7 or repeat of day -7 one week later for those failing to qualify initially and thought likely to qualify on repeat examination prior to randomization. exclusion criteria: * treatment with omega-3 fatty acids or niacin or fibrates within 8 weeks of screening. * patients with confirmed familial chylomicronemia syndrome (fcs) with hyperlipoproteinemia (hlp) type-i diagnosis or known to be homozygotes or compound heterozygotes for mutations in hlp type i-causing genes (such as lpl, apocii, cpihbp1, or lmf1) prior to screening. * pancreatitis within 3 months prior to screening. * uncontrolled type 2 diabetes (t2dm) (as defined by an hba1c value of ≥8.0% at screening) * bmi \> 40 or history of bariatric surgery. * nephrotic syndrome, type 1 diabetes, hiv, hcv or hbv positive. * estimated glomerular filtration rate (egfr) \< 60 ml/min/1.73m2 other protocol defined inclusion/exclusion criteria may apply

Keywords: hypertriglyceridemia non familial chylocmicronemia syndrome (non-fcs)
comparing oxygen saturation in post anesthesia care unit after different methods of pain relief

Conditions: Cryptorchidism

Summary: to determine the which method of pain relief is better after current anesthesia care.

we hypothesized that in children, the current anesthesia care (combined light general anesthesia and caudal analgesia) may decrease incidence of intra and or postoperative de-saturation( sao2 \< %95), the need of oxygen during child's transport to the pacu and during his stay in the recovery room, compared with children who receive intravenous narcotics for intra and postoperative pain relief.

Eligibility criteria:
inclusion criteria: * healthy children * asa physical status 1 or 2 * 1-6 yr old * scheduled for elective uni or bilateral orchidopexy exclusion criteria: * children with compromised pulmonary, cardiac, neurological, hematological, renal condition, with history of prematurely or are obese will be excluded.

Keywords: caudal block oxygen saturation uni or bilateral orchidopexy
stroke in young fabry patients (sifap1): frequency of fabry disease in young stroke patients

Conditions: Cerebrovascular Accident

Summary: more than one million people in europe suffer from a stroke every day. normally older people have a stroke, but also a significant number of younger people between 18 and 55 years. usually, these cannot be explained by the classical risk factors such as diabetes, overweight and high blood pressure. new studies indicate that in about 1 - 2 % of the younger stroke patients the cause could have been an undiagnosed genetic disease, the so called fabry disease. the purpose of this study is to determine in a large number of young stroke patients, how many strokes were caused by fabry disease.

aim: to determine the frequency of fabry disease in an unselected group of young patients (18 - 55 years of age) with acute cerebrovascular event (cve) fabry disease and stroke: rolfs and co-workers have shown a high frequency of fabry disease in a cohort of patients with cryptogenic stroke (4 % \[28/721\]) aged between 18 and 55 years. this corresponds to about 1.2 % in the general population of young stroke patients. therefore the authors stated that fabry disease must be considered in all cases of unexplained stroke in young patients, especially in cases with the combination of infarction in the vertebrobasilar artery system and proteinuria. cryptogenic strokes are cerebrovascular lesions of unknown origin. clinical and laboratory data show that fabry disease is itself a risk factor for accelerated atherosclerosis and cardiac and renal disease, which can lead to emboli and hypertension. the pilot-phase started april 2007; the official study started january 2008.

Eligibility criteria:
inclusion criteria: * adult patients (18 - 55 years of age) with an acute cerebrovascular event of any etiology defined as patients having an acute ischemic stroke or transient ischemic attack less than 3 months before enrollment into the study * mri-scan evidence of associated corresponding brain infarction or hemorrhage, regardless of the duration of symptoms. alternatively also patients with no signs of stroke in the mri can be included if a stroke-experienced neurologist has done the initial diagnosis as ischemic stroke, transient ischemic attack or hemorrhage. * detailed mri documentation at admission to entry to the study * diagnostic procedures for cve according to the eusi recommendations * written informed consent from patient or legal representative according to local regulations exclusion criteria: * patients being younger than 18 years or older than 55 years of age. * acute ischemic stroke or transient ischemic attack longer than 3 months before enrolment into the study * diagnosis of the cve within the last 3 months has been done by a non-neurologist if there is no mri-scan evidence of associated brain infarction or hemorrhage * no detailed mri documentation at admission to entry to the study

Keywords: cerebrovascular accident cerebrovascular accident, acute cva (cerebrovascular accident) cerebral stroke stroke, acute cerebrovascular stroke fabry disease anderson-fabry disease fabry's disease
development and validation of a disease specific prom to assess abdominal involvement in patients with cf (cfabd-score)

Conditions: Cystic Fibrosis

Summary: development, validation and evaluation of a new multimodal questionnaire to assess and quantify the abdominal involvement in patients with the inherited life shortening multi-organ disease cystic fibrosis. in the stepwhise development of the patient reported outcome measures (prom) repeadedly, cf-patients, their families as well as professionals working in different fields of cf-care will be included.

development of a multimodal questionnaire considering the fda guidelines for development of a prom, the cfabd-score * evaluation of reliability of the questionnaire by examining internal consistency and construct validity * evaluation of reproducibility of the questionnaire by re-testing of patients * assessment of cross-generational applicability of the questionnaire by sub-scoring of age groups * evaluation of the responsiveness of the score by comparison with age-matched healthy controls * assessment of putative relationships of abdominal symptoms with faecal inflammatory markers * assessment of applicability of the questionnaire in other cf centers * transfer the cfabd-score to other countries and languages development and validation of a cf-specific tool for daily assessment of abdominal symptoms (patient diary), the cfabd-day2day development and validation of a cf-specific tool for assessment of abdominal symptoms in children \< 12 years of age, the cfabd-kid

Eligibility criteria:
inclusion criteria: cf cohort: diagnosis of cf determined by * a sweat chloride of \>60 meq/l and/or * detection of 2 disease causing cftr mutations with evidence of organ involvement. healthy controls: * age-matched exclusion criteria: cf cohort: * lacking ability to cooperate of patients /their families, respectively healthy controls: * other diseases causing abdominal symptoms (inflammatory bowel disease (ibd), alpha 1 antitrypsin deficiency, celiac disease, food allergy, gastroenteritis, etc.)

Keywords: cystic fibrosis abdomen pancreas liver gut symptom score patient reported outcome measure (prom) diabetes cftr-modulator tricafta kaftrio
study to evaluate pharmacokinetics, pharmacodynamics, and safety of sargramostim administered subcutaneously, intravenously, or by inhalation

Conditions: Drug Kinetics; Drug Effects on Physiology

Summary: this single center, single ascending dose (sad) and repeat dose study in healthy adults comprises 2 parts. part 1 will consist of 6 sad cohorts, in which different dose levels of sargramostim will be given by intravenous (iv) infusion, subcutaneous (sc) injection, or inhalation (ih) administration. part 2 will consist of 1 repeat dose cohort in which sargramostim will begiven by sc administration. blood samples for pk assessment will be collected before and over 24 hours after each study drug administration. blood samples for pd assessment will be collected before and up to 14 days after drug administration in part 1, as well as before the first and up to 14 days after the second drug administration in part 2. safety and tolerability will be assessed throughout the study. for cohort 5 of part 1 only, 3 subjects will provide a csf sample for pk assessmen tonce after sc drug administration.


Eligibility criteria:
inclusion criteria: * healthy adult male and female participants * nonsmoker or ex-smoker * able to provide informed consent and comply with all study procedures * body mass index within 18.5-30.0 kilograms/meter squared, inclusive * females of childbearing potential willing to use highly-effective method of birth control. exclusion criteria: * females who are pregnant or breastfeeding * history of allergic to sargramostim or its excipients, other human gm-csfs, or other yeast-derived products. * history of severe allergic reactions to other drugs. * history of or any current medical condition or laboratory finding that may jeopardize completion of the study, present an increased risk to the subject, or compromise interpretation of the study. . * immunization with covid-19 vaccine within 14 days of the study. * scheduled immunization with covid-19 vaccine during the study * use of prescription drugs within 28 days of the study or requirement for maintenance drugs during the study. * participation in another investigational drug study within 28 days
adipose tissue heterogeneity and its link to type 2 diabetes

Conditions: Type 2 Diabetes

Summary: people with newly diagnosed type 2 diabetes treated with metformin that have not reached their hba1c target (42-64 mmol/mol) will be recruited to the study. if they fulfill the inclusion and none of the exclusion criteria, they will be, after signing informed consent, randomized to a six-month intervention with either pioglitazone, empagliflozin or semaglutide. fat biopsies are obtained from the subcutaneous abdominal area before and after a hyperinsulinemic-euglycemic clamp at baseline and after six months. participants are regularly followed during this the intervention. the overall goal is to determine how antidiabetic-drugs affect white adipose tissue cellularity and whether adipose heterogeneity impacts on drug response. the primary outcome measure is the change in fat tissue lipolysis (glycerol release in isolated fat cells after hormone stimulation) before and after treatment.

a detailed description of the protocol has been approved by the swedish medical products agency and the study is registered as eudract: 2021-002367-21.

Eligibility criteria:
inclusion criteria: * signed informed consent * bmi 25 kg/m2 or higher * hba1c 42 mmol/mol or higher * for fertile women, effective contraception exclusion criteria: * hba1c 65 mmol/mol or higher * established cardiovascular disease and/or heart failure * severe psychiatric condition * active alcoholism * insulin treatment * anticoagulant therapy (vitamin k antagonists or equivalent) * pregnancy, lactation * positive gad or ia2 antibodies * low c-peptide/glucose ratio (less than 2 measured as pmol/mg per dl) * nt-probnp above the upper normal reference value * kidney disease * liver disease or hepatic values over twice the upper reference value * severe concomitant disease including ongoing cancer
a trial for the earlier diagnosis of inferior wall stemi using a six-lead handheld ekg recorder

Conditions: ST Elevation Myocardial Infarction; Electrocardiogram

Summary: the goal of this clinical trial is to compare the result from the a six-leads handheld electrocardiogram (ecg) recorder (kardiamobile 6l) with those of the standard 12-leads ecg at the patients of acute inferior wall st-elevation myocardial infarction (stemi), then ultimately reduce the time it takes to perform re-through treatment according to the faster diagnosis. participants with stemi who visited the emergency room will be recorded 6-leads ecg using kardiamobile 6l in addition to the standard 12-lads ecg, which is basically performed for all patients of acute coronary syndrome.


Eligibility criteria:
inclusion criteria: * among the patients over 19-year-old, patients of st-elevation myocardial infarction who visit the emergency room and perform emergency coronary angiography or * among the patients over 19-year-old, patients who visit outpatient clinics and perform elective coronary angiography for evaluating chest pain exclusion criteria: * patients with severe complications of myocardial infarction; cardiogenic shock, respiratory failure and mental change * patients who are unable to agree or disagree a written consent

Keywords: kardiamobile 6l
long-term extension study of zanubrutinib (bgb-3111) regimens in participants with b-cell malignancies

Conditions: B-cell Malignancies

Summary: the purpose of this study is to evaluate the long-term safety of zanubrutinib regimens in participants with b-cell malignancies who participated in a beigene parent study for zanubrutinib.


Eligibility criteria:
1. currently participating or participated recently in a beigene parent study 2. intent to continue or start zanubrutinib treatment after any of the following: 1. at time of final analysis or study closure of the eligible beigene parent study 2. at time of progressive disease (pd); and investigator, patient and medical monitor agree it is in the patient's best interest 3. at an alternative timepoint for an alternative reason 3. patient who is currently on zanubrutinib treatment: does not meet any protocol-specified criteria for zanubrutinib hold or permanent discontinuation, and, in the opinion of the investigator, will continue to benefit from zanubrutinib treatment 4. zanubrutinib-naive patient: must meet the following criteria ≤ 15 days before first dose of study drug: 1. platelets ≥ 50,000/mm3 2. absolute neutrophil count ≥ 750/mm3 3. aspartate aminotransferase (ast) and alanine aminotransferase (alt) ≤ 3 x upper limit of normal 4. serum total bilirubin ≤ 3 x upper limit of normal (not required for gilbert syndrome) 5. qt interval corrected for heart rate using fridericia's formula (qtcf) ≤ 480 msec 6. no known new york heart association (nyha) class iii or iv congestive heart failure 7. creatinine clearance ≥ 30 ml/min 5. female participants of childbearing potential and nonsterile males must be willing to use a highly effective method of birth control. key exclusion criteria: 1. permanently discontinued from zanubrutinib treatment in the beigene parent study due to unacceptable toxicity, non-compliance with study procedures, or withdrawal of consent 2. uncontrolled active systemic infection or recent infection requiring parenteral anti-microbial therapy 3. life-threatening illness, medical condition or organ system dysfunction which, in the investigator's opinion, could compromise the participant's safety, interfere with the absorption or metabolism of zanubrutinib, or put the study outcomes at undue risk 4. concomitant chemotherapy, targeted therapy, radiation therapy, antibody-based therapies, or any prohibited concomitant therapy outlined in the protocol 5. pregnant or lactating woman 6. inability to comply with study procedures 7. concurrent participation in another therapeutic clinical study 8. history of progressive disease (pd) while receiving a btk inhibitor (excluding zanubrutinib) note: other protocol defined inclusion/exclusion criteria may apply

Keywords: zanubrutinib bruton's tyrosine kinase (btk) inhibitor long-term extension
combination chemotherapy in treating patients with metastatic kidney cancer

Conditions: Kidney Cancer

Summary: rationale: drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. combining more than one chemotherapy drug may kill more tumor cells. purpose: phase ii trial to study the effectiveness of combining doxorubicin and ifosfamide in treating patients who have metastatic kidney cancer.

objectives: i. determine the efficacy in terms of objective response after treatment with ifosfamide and doxorubicin in patients with metastatic sarcomatoid renal cell cancer. ii. determine the toxicity of this regimen in these patients. iii. determine the effect of this regimen on the survival of these patients. outline: this is a multicenter study. patients receive doxorubicin iv on day 1 and ifosfamide iv over 2 hours on days 1 and 2. treatment is repeated every 3 weeks for up to 8 courses in the absence of disease progression or unacceptable toxicity. projected accrual: a total of 20-40 patients will be accrued for this study within 3 years.

Eligibility criteria:
disease characteristics: histologically proven metastatic, sarcomatoid renal cell carcinoma measurable disease at least 15 mm for pulmonary sites at least 20 mm for other sites no uncontrolled cns metastases patient characteristics: age: 18 and over performance status: who 0-2 life expectancy: greater than 3 months hematopoietic: neutrophil count greater than 1500/mm3 platelet count greater than 100,000/mm3 hemoglobin greater than 9 g/dl hepatic: bilirubin less than 1.5 times normal transaminases less than 2 times normal (less than 4 times normal if due to liver metastases) renal: creatinine less than 1.6 mg/dl creatinine clearance greater than 60 ml/min other: no contraindication to anthracycline treatment no unstable major organ defect no prior malignancy except basal cell skin cancer or carcinoma in situ of the uterus not pregnant or nursing fertile patients must use effective contraception prior concurrent therapy: biologic therapy: no prior immunotherapy chemotherapy: no prior chemotherapy endocrine therapy: not specified radiotherapy: not specified surgery: not specified

Keywords: stage iv renal cell cancer
periosteal chondrosarcoma: a single institution experience

Conditions: Periosteal Chondrosarcoma

Summary: periosteal chondrosarcoma is a low-grade, malignant cartilaginous bone neoplasm that arises on the surface of bone, predominantly in the metaphysis of long bones. periosteal chondrosarcoma is an infrequent chondrosarcoma subtype which accounts for less than 1% of all chondrosarcomas (1) and has a peak incidence in the fourth decade (2). it has a reported incidence of local recurrences of 13-28% and a low metastatic potential, with distant recurrences occurring mostly in lungs (3). contrary to conventional chondrosarcomas, grading of periosteal chondrosarcomas seems not to predict prognosis. idh1 and idh2 mutations, characteristics of central chondromas/chondrosarcomas, have been also found in a subset of periosteal chondrosarcomas (1, 4). these observations are based on the results from smaller series of cases (1, 5, 6), although the impact of histopathological characteristics on survival, local recurrence and metastases should be assessed in larger series of cases. the aim of the present study is to review all the cases with a diagnosis of primary periosteal chondrosarcoma treated at the rizzoli institute from 1900 up to 31 december 2019, retrospectively. the study will exam all the clinical, radiological, and histological features of this tumor with regard importance of medullary involvement, the idh1/2 gene status, the types of treatment, the status of surgical margins, the presence of progression (dedifferentiation) areas and the relationship of these factors to individual outcome.


Eligibility criteria:
inclusion criteria: * male and female patients treated at rizzoli institute from 01 jan 1900 to 31 dec 2019 * diagnosis of peristeal chondrosarcoma * written informed consent prior to any study-specific analysis and/or data collection exclusion criteria: * patients with histological diagnosis different from periosteal chondrosarcoma.