Kornimate/medical-research-clean huggingface dataset:
a study to investigate safety and tolerability of sh3809 tablet in patients with advanced solid tumors

Conditions: Advanced Solid Tumor

Summary: the primary objective is to determine the safety and tolerability of sh3809 in subjects with advanced solid tumors. the second objective is to evaluate the pk profile and preliminary efficacy of sh3809 in solid tumors.

this is a phase i, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of sh3809 tablet, a small molecule inhibitor of shp2 receptor , in patients with advanced solid tumors.

Eligibility criteria:
inclusion criteria: 1. age between 18 and 75 years inclusive; 2. histologically or cytologically confirmed advanced malignant solid tumors, eligible patients should be either refractory or intolerant to all available therapies known to confer a clinical benefit as determined by the investigator, except for primary hepatic carcinoma; 3. eastern cooperative oncology group (ecog) performance status of 0 or 1; 4. life expectancy ≥ 3 months; 5. adequate hematologic, hepatic and renal function; 6. participant willing to agree to not father a child/become pregnant and comply with effective contraception criteria; 7. provision of signed and dated, written informed consent prior to any study-specific evaluation. exclusion criteria: 1. previous treatment with any shp2 inhibitors; 2. spinal cord compression, meningeal metastases or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment; 3. life-threatening autoimmune disease or autoimmune disorder with long-term steroid treatment; 4. active infection with hepatitis b virus (hbv), hepatitis c virus (hcv), human immunodeficiency virus (hiv) and treponema pallidum (tp); 5. patients who have impaired cardiac function or clinically significant cardiac diseases; 6. active, clinically significant interstitial lung disease or pneumonitis; 7. females who are pregnant or breastfeeding; 8. judgment by the investigator that the patient should not participate in the study.

Keywords: advanced solid tum shp2 egfr nsclc colorectal cancer kras g12
registry of arterial hypertension

Conditions: Arterial Hypertension

Summary: the problem of the quality of primary health care medical system for patients with arterial hypertension is acute for the investigator's country, as these diseases are the most common and cause the high mortality of the population. the concept of "quality of primary health care medical system" includes its timeliness, accessibility and provision of medical care to the patient at the modern level, which is determined by the degree of performance by doctors of medical and diagnostic measures corresponding current clinical recommendations. the system of cardiovascular desease registries, established in the federal state clinical hospital of the russian federation ministry of public health with the automated analysis of data on examination and treatment, in comparison with clinical recommendations. it makes possibility to identify shortcomings and develop approaches to improving the provision of medical care to patients in real clinical practice. comparative analysis of the quality of examination and treatment in different samples of patients with cardiovascular desease, observed in 2018-2020, compared with results of previous years will identify ptrends in the provision of medical care to patients with cardiovascular desease.

the study will be conducted using the arterial hypertension registry method, which is a computer program with remote access that allows online collection medical data from medical primary care system. to minimize operator errors, doctors was trained before the work with the arterial hypertension registry. user's guide was developed and the rights of users was determined. data of examination and treatment of patients from 18 years and older with an established diagnosis of hypertension will be added from outpatient cards into the registry of the arterial hypertension. the information is received by the institution in an impersonal form through a certified dedicated security channel. patients sign an informed consent for entering their medical data into the registry of arterial hypertension

Eligibility criteria:
inclusion criteria: the diagnosis of arterial hypertension - exclusion criteria: no diagnosis of arterial hypertension -
prospective cohort study in patients with nafld

Conditions: Non-alcoholic Fatty Liver Disease

Summary: to assess the importance of intracellular signalling pathways and its deregulation in adiposity and diabetes-related insulin resistance, liver tissue samples of patients suffering from non-alcoholic fatty liver disease (nafld) and non-alcoholic steatohepatitis (nash)will be analyzed prospectively from a liver tissue bank.

patients with suspected fatty liver disease will be screened (and excluded in the presence) of alternative clinical condition associated with nafld (see exclusion criteria). of all patients fulfilling inclusion criteria, relevant baseline characteristics (incl. epidemiological, physiological and biochemical data) will be obtained. in addition, radiological examination will be performed using sonography and fibroscan to assess non-invasively the individual extent of hepatic fat deposition, liver stiffness (fibrosis) and amount of visceral fat mass. in case of high clinical, laboratory and radiological suspicion for nafld, a diagnostic liver biopsy will be performed. a part of the liver tissue is used for histological confirmation of nafld and subsequent grading and staging according established criteria. parts of the remaining liver tissue will be stored for later molecular and histological analysis. in addition, several serum samples are collected of patients and stored for future analysis. all patients will be followed up annually (incl. physical examination, metabolic characterisation, clinical chemistry and liver sonography) and additional serum samples will be collected for future analysis. liver biopsy is not repeated after defined time period, but in case of clinical evidence for disease progression.

Eligibility criteria:
inclusion criteria: * patients with histologically confirmed fatty liver disease exclusion criteria: * history of significant alcohol consumption * viral hepatitis * autoimmune hepatitis * metabolic diseases (e.g. hemochromatosis, m. wilson, alpha 1-antitrypsin deficiency) * hepatotoxic medication (e.g. amiodarone).
randomized study of pergolide in children with tourette syndrome

Conditions: Tourette Syndrome

Summary: objectives: i. evaluate the presumed mechanism of action of low dose pergolide to act acutely through the dopaminergic autoreceptor or postsynaptically at d2 sites in children 7 to 17 with tourette syndrome (gts). ii. compare tolerability and safety of pergolide in these patients to standard neuroleptic therapy via naturalist assessment after 3-6 months of treatment using matched historical controls on neuroleptics. iii. determine efficacy of pergolide for tic control in these patients.

protocol outline: this is a three part study: part i is a randomized, double blind, fixed single dose study; part ii is a randomized, open label, stratified study; and part iii is a randomized, double blind, placebo controlled study. part i patients are randomized to receive oral pergolide at one of three dose levels or placebo for 10 weeks. part ii patients are randomized to receive either low or high dose pergolide for 4 weeks. part iii patients are randomized to first receive either pergolide or placebo by oral fixed doses twice daily followed by flexible clinically adjusted dosing for the next 3 weeks after a 2-week placebo run-in. patients then cross over to receive the other treatment after another 2 weeks of placebo run-in. total treatment duration is 16 weeks. patients are followed at 6 months. completion date provided represents the completion date of the grant per oopd records

Eligibility criteria:
protocol entry criteria: --disease characteristics-- dsm iv primary diagnosis of tourette syndrome (gts) multiple axis i and axis ii diagnoses allowed tourette symptom severity great enough to warrant medication (cgi severity index at least 4) no chronic motor tic disorder or transient tic disorder, anorexia nervosa, pervasive developmental disorders, substance/alcohol abuse or dependence within the past year, schizophrenia or any psychotic disorder --prior/concurrent therapy-- at least 4 weeks since prior neuroleptic therapy at least 2 weeks since all other prior medications no concurrent neuroleptic therapy or psychotropic therapy (i.e., antidepressant or anticholinergic) no concurrent medication that may alter or interact with pergolide --patient characteristics-- performance status: outpatient status hematopoietic: normal or clinically insignificant values hepatic: normal or clinically insignificant values renal: normal or clinically insignificant values cardiovascular: normal electrocardiogram other: no serious or unstable medical illness (i.e., diabetes, seizure disorder); must be able to perform required measurements (i.e., no low i.q.); effective contraception required by all fertile patients

Keywords: tourette syndrome neurologic and psychiatric disorders rare disease
pangenomic study during alcoholic cirrhosis

Conditions: Alcoholic Cirrhosis

Summary: hepatocellular carcinoma (hcc) is a frequent complication of cirrhosis. occurrence of hcc could be linked with multiple functional region of genome. the determining of a genomic mapping of " single nucleotide polymorphisms " (snps) permit to perform some genetic link studies with pathologies without clear hereditary disposition. in this study, the investigators will identify predictives genetic polymorphism of hcc.


Eligibility criteria:
inclusion criteria: * 35 to 70 years old * compensated cirrhosis or not * caucasian origin of the parents * patient with cirrhosis (histological proof or obvious) exclusion criteria: * hiv, hbv, hcv positive * known homozygotia (c282y+/+) * important hepatocytary iron overload for patient with resection * hcc non histologically prooved
study of stress and life quality of patients participating in clinical trials versus patients non participating

Conditions: Metastatic Neoplasm; Recurrent Hematologic Cancer

Summary: this study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way.

this study aims to assess anxiety/depression and life quality of patients included in clinical trials versus patients treated in a standard way a case-control study

Eligibility criteria:
inclusion criteria: * patient with solid tumor or recurrent hematologic cancer, treated by chemotherapy or targeted therapy evaluated every 2 or 3 cycles; except for clinical trials associating non drug treatment (radiotherapy, surgery...) * subject to a 1st, 2nd or 3rd line of antitumor treatment * a phase 2 open labeled study, * a phase 2 or 3 blind randomised study, * a phase 2 or 3 open randomised study, * a standard treatment non participating to a clinical trial * male or female patients ≥ 18 years of age * karnovsky ≥ 70 % or oms ≤ 2 * recovered from prior toxicities * social security covered * written informed consent given exclusion criteria: * psychiatric disorders, receiving psychotropic treatment * physical or psychological issues * forbidden to be included in this study

Keywords: stress life quality adjustment strategy receiving an antitumor treatment within a clinical trial (case) according to a standard treatment (control)
study of anti-telomerase t cd4 immunity in melanoma

Conditions: Melanoma

Summary: the impressive clinical responses obtained with immune checkpoint inhibitors (anti-pd-1/pdl-1, anti-ctla-4) indicate that the presence of preexisting antitumor immune response might be required for their efficacy and highlight the critical role of antitumor t cell immunity. recent progresses on the field of tumor immunology underline the critical role of cd4 helper 1 t lymphocyte (th1) in the control of innate and adaptive anticancer immunity. therefore, monitoring tumor specific th1 response could be relevant in cancer patients. in order to monitor tumor-specific cd4 th1 responses in most cancer patients, the investigators team have previously described novel promiscuous peptides (referred as ucp: universal cancer peptides) derived from human telomerase (tert), a prototype of shared tumor antigen. by using ucp-based immuno-assay, ucp specific th1 immune responses will be evaluated in this study in melanoma before and after treatment.


Eligibility criteria:
inclusion criteria: * patient with melanoma, any stade, without history of anti-cancer treatment (surgery, chemotherapy, targeted therapy, immunotherapy...) except for patients with stade iv melanoma for which immunotherapy or targeted therapy is considered. in this case, a first-line chemotherapy treatment is allowed * written informed consent exclusion criteria: * patient with immunosuppressive treatment * active autoimmune diseases, hiv, hepatitis c or b virus * patients under guardianship, curatorship or under the protection of justice, pregnant women
lurbinectedin monotherapy in participants with advanced or metastatic solid tumors

Conditions: Advanced Solid Tumor; Metastatic Solid Tumor; Urothelial Cancer; Poorly Differentiated Neuroendocrine Carcinomas; Homologous Recombination Deficient-Positive Malignancies Agnostic

Summary: this is an open-label, multicenter, phase 2 study of lurbinectedin monotherapy in participants with advanced (metastatic and/or unresectable) solid tumors.

this phase 2, multicenter, open-label study is designed to assess the safety and efficacy of lurbinectedin monotherapy in 3 cohorts of participants with high-unmet medical need: advanced (metastatic and/or unresectable) urothelial cancer (uc), poorly differentiated neuroendocrine carcinomas (pd-nec), and a homologous recombination deficient-positive malignancies agnostic cohort.

Eligibility criteria:
inclusion criteria: 1. signed informed consent 2. ≥ 18 years of age 3. eastern cooperative oncology group (ecog) performance status of 0 or 1 4. adequate organ and bone marrow function 5. has measurable disease per response evaluation criteria in solid tumors (recist) v1.1. 6. have advanced (metastatic/unresectable) cancers in one of the following: 1. histologically or cytologically confirmed urothelial cancer 2. histologically or cytologically confirmed poorly differentiated neuroendocrine carcinoma 3. histologically or cytologically confirmed homologous recombination deficient-positive malignancies agnostic, which may include endometrial, biliary tract, urothelial, breast (tnbc or hr+her2- breast cancer), pancreas, gastric, or esophageal solid tumors with preidentified germline and/or somatic pathogenic mutation 7. adequate contraceptive precautions exclusion criteria: 1. known symptomatic central nervous system (cns) metastasis requiring steroids 2. history of prior malignancy within 2 years of enrollment 3. clinically significant cardiovascular disease 4. active infection requiring systemic therapy 5. significant non-neoplastic liver disease 6. prior treatment with trabectedin or lurbinectedin 7. treatment with an investigational agent within 4 weeks of enrollment 8. received live vaccine with 4 weeks of first dose 9. prior allogeneic bone marrow or solid organ transplant 10. positive hepatitis b virus (hbv) or hepatitis c virus (hcv) infection at screening 11. positive human immunodeficiency virus (hiv) infection at screening

Keywords: lurbinectedin monotherapy urothelial cancer poorly differentiated neuroendocrine carcinomas homologous recombination deficient-positive malignancies agnostic
ultrasound shear wave elastography evaluation of suspected and known biliary atresia

Conditions: Biliary Atresia

Summary: the investigators plan to investigate the use of us shear wave elastography (swe), a newly available imaging technology, in children with suspected/known ba.

the investigators plan a prospective, multi-center study to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation can discriminate biliary atresia (ba) from other causes of liver disease in the setting of neonatal cholestasis. the investigators also plan to determine if liver ultrasound shear wave speed measurements acquired at clinical presentation or longitudinally during the first one-year period after kasai can predict important long-term outcomes in ba patients.

Eligibility criteria:
inclusion criteria: * neonatal cholestasis with concern for ba vs. other liver disease direct bilirubin \>20% of total or ≥2 mg/dl age \<3 months exclusion criteria: * inability to obtain parent/guardian consent. * inability to return for follow up visits as required by the study (these patients will be included in aim 1, but will be unable to participate in aim 2). * no other exclusion criteria.
a meal test study of ly900014 in participants with type 1 diabetes mellitus

Conditions: Diabetes Mellitus, Type 1

Summary: two forms of insulin lispro (ly900014 and humalog®) and two forms of insulin aspart (novorapid® and fiasp®) will be given to trial participants with diabetes mellitus type 1 by injection under the skin. the study will assess how fast the active ingredient (insulin lispro or insulin aspart) gets into the blood stream and how long it takes the body to remove it. a test meal will be given to trial participants to assess the course of the blood sugar lowering effect of the investigational products. the safety and tolerability of ly900014 will also be assessed. screening is required within 14 days prior to the lead in. for each participant, the study will last up to 91 days.


Eligibility criteria:
inclusion criteria: * are male or female participants with type 1 diabetes mellitus (t1dm) for at least 1 year * have a body mass index (bmi) of 18.5 to 35.0 kilogram per meter square (kg/m²) * have a glycated hemoglobin (hba1c) less than (\<)9.0 percent (%) * have had no episodes of severe hypoglycaemia in the last 6 months exclusion criteria: - have a history or current cardiovascular, respiratory, hepatic, renal, gastrointestinal, endocrine (apart from t1dm), hematological, or neurological disorders capable of significantly altering the absorption, metabolism or elimination of drugs; of constituting a risk when taking the investigational product; or of interfering with the interpretation of data
biomarkers related to thrombosis in patients with newly diagnosed multiple myeloma receiving chemotherapy

Conditions: Multiple Myeloma; Plasma Cell Neoplasm; Thromboembolism

Summary: rationale: studying samples of blood in the laboratory from patients receiving chemotherapy may help doctors learn more about the effects of chemotherapy on cells. it may also help doctors understand how patients respond to treatment. purpose: this research study is studying biomarkers related to thrombosis in patients with newly diagnosed multiple myeloma receiving chemotherapy.

objectives: primary * to measure levels of circulating tissue factor (tf) in patients with newly diagnosed multiple myeloma at several time points before, during, and after the administration of chemotherapy and/or antiangiogenic agents. secondary * to measure the correlation of tf with two markers of coagulation activation (i.e., d-dimer, thrombin-antithrombin \[tat\] complexes) and two markers of endothelial activation (i.e., soluble e-selectin, soluble thrombomodulin) in these patients. * to measure and compare (descriptively) our microparticle-associated tf procoagulant activity assay with two other assays using samples from these patients. outline: patients undergo blood sample collection at baseline and then periodically during treatment. circulating tissue factor (tf) activity levels and coagulation and endothelial activation (by elisa) are measured. medical charts are reviewed for sociodemographic and medical information. after completion of study, patients are followed up for 3 months.

Eligibility criteria:
disease characteristics: * newly diagnosed; relapsed, or refractory multiple myeloma patient characteristics: * central venous access devices allowed * recruited by the division of hematology/oncology and the lineberger comprehensive cancer center at the university of north carolina * no history of venous thromboembolism * no hospitalization for \> 2 days within the past month * not pregnant * no patient who refuses or is deemed unsuitable for chemotherapy prior concurrent therapy: * no surgery within the past month * bone marrow biopsies, central venous line placement and diagnostic biopsies by surgery or fine-needle aspiration allowed * \* no concurrent anticoagulation therapy * concurrent antiplatelet agents, such as aspirin and/or clopidogrel, allowed

Keywords: thromboembolism stage i multiple myeloma stage ii multiple myeloma stage iii multiple myeloma
study to establish the diagnostic performance of 18f fluciclovine pet in detecting recurrent brain metastases

Conditions: Brain Metastases

Summary: an open-label, single dose, single arm, prospective, multicenter phase 3 study to establish the diagnostic performance of 18f fluciclovine positron emission tomography (pet) in detecting recurrent brain metastases after radiation therapy


Eligibility criteria:
inclusion criteria: 1. eastern cooperative oncology group (ecog) performance status of 0-1, or 2 if this is an acute deterioration 2. previous history of solid tumor brain metastasis of any origin 3. histopathological confirmation of the primary solid tumor or a metastatic site within 4 years 4. previous radiation therapy of brain metastatic lesion(s) 5. a reference lesion considered by the site investigator to be equivocal for recurrent brain metastasis 6. patient requires further confirmatory diagnostic procedures to confirm brain mri findings and is planned for biopsy/neurosurgical intervention as standard of care (soc) or clinical follow-up as soc exclusion criteria: 1. patients with a history of active hematological malignancy

Keywords: recurrent brain metastases diagnostic positron emission tomography (pet) scan
efficacy of ciclesonide versus placebo administered either as once daily or twice daily in patients treated previously with an inhaled corticosteroid

Conditions: Asthma

Summary: to investigate the efficacy of ciclesonide mdi either as once daily or a twice daily regimen in patients with mild to moderate asthma, who have previously been treated with an inhaled corticosteroid.


Eligibility criteria:
inclusion criteria: * males or females 12 years or older * history of persistent bronchial asthma for at least 6 months * documented use of an inhaled steroid or a combination of an inhaled steroid/long-acting beta 2 agonist for at least 1 month before screening * at screening, fev1 of 60 to 90% predicted or 70 to 95% predicted for either ics or ics/laba use respectively.reversibility of fev1 by at least 12% and 200 ml post-bronchodilator * be able to use oral inhalers * non-smokers exclusion criteria: * history of life-threatening asthma * other pulmonary diseases; uri within 4 weeks before screening * use of systemic steroids within 1 month before screening or more than 3 times in previous 6 months * beta-adrenergic blocking agent use * more than 2 in-patient hospitalizations or er visits due to asthma exacerbations in the prior year before screening * pregnant or breast-feeding females * females of child-bearing potential not using adequate means of birth control * clinically relevant cardiovascular, hepatic, neurologic, endocrine, or other major systemic disease * abnormal clinical laboratory parameters that would limit participation in the study or interfere with interpretation of study results * history of drug or alcohol abuse * treatment with any investigational product within 30 days prior to study entry

Keywords: glucocorticosteroid. bronchospasm