Kornimate/medical-research-clean huggingface dataset:
investigation of psma pet/ct as an imaging biomarker in solid tumors

Conditions: Prostate-specific Membrane Antigen; mCRPC or Advanced/Metastatic Solid Tumors

Summary: multi-centre, prospective, diagnostic trial to evaluate the prostate-specific membrane antigen (psma-antigen) over-expression in metastatic castration resistant prostate cancer (mcrpc) and in advanced/metastatic solid tumors patients.

multi-centre, prospective, diagnostic trial to evaluate the prostate-specific membrane antigen (psma-antigen) over-expression in metastatic castration resistant prostate cancer (mcrpc) and in advanced/metastatic solid tumors patients. the primary objective of this study is to evaluate the detection rate of psma pet/ct, defined as the ratio of psma-positive patients and the total number of cancer patients with known advanced/metastatic disease that performed a psma pet/ct as part of the present study. a positive patient is defined as a patient with at least one psma-positive lesion.

Eligibility criteria:
inclusion criteria: 1. patients with mcrpc or advanced/metastatic solid tumors; 2. male or female, aged \>18 years; 3. written informed consent; 4. relapse or progression of disease on ct scan and / or mri; 5. if female of childbearing potential, highly effective birth control methods according to guideline "recommendation related to contraception and pregnancy testing in clinical trials" (2014_09_15 section 4.1) are mandatory, beginning at the screening visit and continuing until 6 months following last 68ga-psma pet/ct. 6. eastern cooperative oncology group (ecog) performance status ≤ 2 exclusion criteria: 1. pregnancy / nursing; 2. participation in another clinical trial with any investigational agents within 30 days prior to study entry 3. medical or psychological conditions that would not allow the participant to understand, or sign the informed consent. 4. history of allergic reactions attributed to compounds of similar chemical or biologic composition to 68ga-psma or other agents used in the study. 5. inability to remain still for the entire duration of the exam

Keywords: mcrpc or advanced/metastatic solid tumors prostate-specific membrane antigen
addition of tobramycin inhalation in the treatment of ventilator associated pneumonia

Conditions: Ventilator Associated Pneumonia (VAP)

Summary: this study evaluates the addition of tobramycin inhalation treatment to standard intravenous therapy in the treatment of ventilator associated pneumonia.

rationale: approximately 9-27% of mechanically ventilated patients in the intensive care unit (icu) develop ventilator-associated pneumonia (vap). patients in whom vap develops have a higher mortality rate up to 50%, stay longer in the intensive care unit (icu), and require more resources than those without the disease. despite the availability of modern icu care and modern antibiotics, the overall clinical cure rate after 72 hours of antibiotic treatment for vap is only 40%. the cure rate for pseudomonas aeruginosa is even lower. it is unclear why vap cure rates are so low. the ats guidelines recommend iv antibiotic treatment (iv ab), especially directed against gram-negative microorganisms. however, the relatively poor response rates seen with intravenous therapy of vap and the emergence of mdr organisms makes new treatment options desirable. the ats/idsa vap guidelines recommend that "adjunctive therapy with an inhaled aminoglycoside or polymyxin (colistin) for mdr gram-negative pneumonia should be considered, especially in patients who are not improving". it is therefore necessary to investigate whether adjunctive therapy with inhalation tobramycin could ameliorate prognosis. the recommendations by the society of infectious diseases pharmacists are similar.

Eligibility criteria:
inclusion criteria: * mechanical ventilation 48 hours or more * new or progressive radiologic pulmonary infiltrate together with at least two of the following three criteria (\< 24 h): * temperature \>38°c * leukocytosis \>12,000/mm3 or leucopenia \<4,000/mm3 * purulent respiratory secretions exclusion criteria: * patients with allergy to tobramycin * pregnancy * expected to die within 72 hours after enrollment
prospective and retrospective observational evaluation of real world outcome of unfit aml patients treated with the combination venetoclax plus hypomethylating agents, under the italian law no.648/96

Conditions: Acute Myeloid Leukemia

Summary: this is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of hma plus venetoclax in aml patients unfit for intensive chemotherapy in a "real-life" scenario. no additional procedures or visits other than those required by normal clinical practice will be required. patients will be observed for at least 24 months.

this is an retrospective and prospective observational multinstitutional study to evaluate the impact on outcome of the combination of hma plus venetoclax in patients with aml unfit for intensive chemotherapy in a "real-life" scenario. at least 104 aml adult patients ineligible for intensive chemotherapy treated with the combination hma plus venetoclax under the italian law no.648/96 by december 2021 will be enrolled. no additional procedures or visits other than those required by normal clinical practice will be required. patients will be observed for at least 24 months.

Eligibility criteria:
inclusion criteria: * patients aged ≥ 18 years with a diagnosis of previously untreated primary or secondary aml; * deemed ineligible for intensive chemotherapy because of age (≥75 years), performance status or comorbidities as defined by the treating physicians, according to sie/sies/gitmo criteria; * eligible to receive the combination hma plus venetoclax under the italian law no.648/96 by december 2021; * signed written informed consent according to ich/eu/gcp and national local laws. exclusion criteria: * acute promyelocytic leukemia; * previous first-line treatments for aml; * previous treatments with hma.

Keywords: venetoclax unfit aml patients hypomethylating agents
biomarkers to predict the response to pembrolizumab in chinese nsclc patients

Conditions: NSCLC Stage IV

Summary: pembrolizumab is approved for advanced stage non-small cell lung cancer. however, the response rate is low (around 10-15 %) in patients treated in macau sar, china. the investigators hypothesize cd38 expressing cells and/or other immune populations will help to predict response.

lung cancer is the leading cause of cancer death, the overall survival rate is low. recently, using anti-pd-l1 immunotherapy for treatment of cancer shows promising in some types of cancer, including melanoma, head and neck squamous cell cancer, and lung cancer etc. pembrolizumab is a fda-approved anti-pd-l1 drug for treatment of advanced stage non-small cell lung cancer. in china, it is approved for used in macau and hong kong. biomarkers associated with predictive response includes pd-l1 high expression, high mutational burden, and t-cell infiltration based on several clinical trial studies in the western countries. however, the response rate is low (around 10-15 %) in patients treated in macau sar, china. the investigators hypothesize that immunophenotying, molecular analysis and functional characterization of cd38 expressing cells and/or other immune populations cd38 will help to identify predictive, progression and resistance markers associated with pdl1 treatment response. the investigators will collect the blood samples of pembrolizumab response and non-response chinese lung cancer patients and compare the imumnophenotypic and molecular dynamic changes during treatment courses. the investigators will also examine the role of cd38 and other molecular markers associated with pembrolizumab response, functional characterize in vitro. the molecular mechanism controlling pembrolizumab response will be better understood for designing a better treatment strategy.

Eligibility criteria:
inclusion criteria: * above 18 years of age * locally advanced (stage iiib) or metastatic (stage iv) nsclc, not amenable to curative surgery or radiotherapy * with pd-l1test available * progressed on previous treatment, or treatment native patients. patients may have also received additional lines of treatment * received pembrolizumab treatment in the participating site. exclusion criteria: * enrollment in studies that prohibit any participation in this observational study * no serum samples available

Keywords: nsclc pd-l1 biomarkers
influence of hydrocortisone on immunologic markers and health care related quality of life in patients after cardiac surgery

Conditions: Systemic Inflammatory Response Syndrome; Posttraumatic Stress Disorder

Summary: hydrocortisone has been shown to improve the early outcome of high risk patients after cardiac surgery. a potential mechanism resulting in this effect may be its immunomodulatory action. in this prospective interventional study this hypothesis is to be proven.

methods: prospective interventional randomized double blind placebo controlled study. intervention: hydrocortisone in stress doses vs. placebo patients: 92 high risk patients after cardiac surgery measurements: cytokines, toll-like receptors, nf kappa b, outcome data, health care related quality of life, ptsd.

Eligibility criteria:
inclusion criteria: * preoperative left ventricular ejection fraction below 39 % duration of the extracorporeal circulation more than 97 min exclusion criteria: * pregnancy * severe liver insufficiency * severe renal insufficiency * insulin dependent diabetes mellitus * steroid therapy * psychiatric disease

Keywords: cardiac surgery systemic inflammatory response syndrome health-related quality of life
patient-reported outcomes in the treatment of schizophrenia

Conditions: Schizophrenia

Summary: patient-reported health economic outcomes for patients enrolled in s1543003 and s1543004 protocols


Eligibility criteria:
inclusion criteria: * participate in s1543003 and s1543004 in the u.s. sites exclusion criteria: * participate in s1543003 and s1543004 other than u.s. sites
phase ii study of the pathophysiology and treatment with enalapril and polystyrene sulfonate for pseudohypoaldosteronism, type i

Conditions: Pseudohypoaldosteronism

Summary: objectives: i. establish the sodium and potassium intake that will maintain a normovolemic state in a patient with pseudohypoaldosteronism. ii. determine the effect of extracellular fluid volume and serum potassium manipulations on exercise tolerance, cardiac function, and endurance. iii. investigate pharmacologic methods of limiting excretion of sodium in urine and sweat.

protocol outline: sodium and potassium intake resulting in normalization of serum electrolytes and markers of extracellular volume are determined at baseline. a trial diet is then prescribed, with adjustments made to achieve a steady state with normal serum electrolytes. exercise tolerance and muscle function are evaluated at steady state. sodium and potassium are sequentially manipulated with diet, enalapril, and polystyrene sulfonate. exercise tolerance is evaluated during each diet period. a treatment plan to maintain electrolyte balance is developed. the patient is followed monthly for 3 to 6 months, then every 3 months for up to 3 years.

Eligibility criteria:
protocol entry criteria: pseudohypoaldosteronism

Keywords: endocrine disorders pseudohypoaldosteronism rare disease
bioequivalency study of calcitriol tablets under fasting conditions

Conditions: Secondary Hyperparathyroidism; Hypocalcemia

Summary: the objective of this study was to assess the bioequivalence of roxane laboratories' calcitriol capsules, 0.25 mcg, to rocaltrol® capsules, 0.25 mcg (roche) using a single-dose, 2-treatment, 2-period, crossover design, under fasting conditions


Eligibility criteria:
inclusion criteria: * no clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening. exclusion criteria: * positive test for hiv, hepatitis b, or hepatitis c. * treatment with known enzyme altering drugs. * history of allergic or adverse response to calcitriol or any comparable or similar product.
implication of cardiac shock wave therapy on coronary artery disease

Conditions: Cardiac Ischemia

Summary: coronary heart disease (chd) is a public health care challenge. there are three types of treatment for chd, medication, percutaneous coronary intervention (pci) and coronary artery bypass graft (cabg). however, some end-stage chd patients lost the chance to get those treatment. cardiac shock wave therapy (cswt) is a new developed therapy for these patients, which is used in tens of countries all over the world. safety, invasiveness, effectiveness is its advantage. ischemia condition can be improved after cswt. there are only three cities in china run the program of cswt, which are kunming, beijing and shanghai. the investigators designed a randomized double-blind study to evaluate the effectiveness and safety of cswt.

coronary heart disease (chd) is a public health care challenge, which lead to 3.5 millions of people died in china every year. there are three types of treatment for chd, medication, percutaneous coronary intervention (pci) and coronary artery bypass graft (cabg). however, some end-stage chd patients with severe cardiac ischemia lost the chance to get those treatment. their quality of life is influenced by recurrent angina. cardiac shock wave therapy (cswt) is a new developed therapy for these patients, which is used in tens of countries all over the world. german and japan are the countries earliest used cswt. safety, invasiveness, effectiveness is its advantage. ischemia condition can be improved after cswt by objective examination. new small vessels generation on ischemia area was found on mice and pig model. there are only three cities in china run the program of cswt, that are kunming, beijing and shanghai. beijing hospital has the only cswt machine in beijing. the investigators designed a randomized double-blind study to evaluate the effectiveness and safety of cswt.

Eligibility criteria:
inclusion criteria: 1. multiple or diffused coronary artery stenosis by coronary angiography and not candidate for pci or cabg; 2. myocardial ischemia and/or cardiac dysfunction by objective exams; 3. angina and/or heart failure could not be control after optimal medication treatment for coronary artery disease; 4. lvef is above 30%; 5. signed informed consent exclusion criteria: 1. acute myocardial infarction; 2. within one month after pci or cabg; 3. heart transplant patient; 4. mechanic valve implantation patient; 5. uncontrolled heart failure with lvef less than 30%; 6. severe arrhythmia; 7. pacemaker implantation patient; 8. infective endocarditis; 9. severe chronic obstructive pulmonary disease patient; 10. pregnant or nursing patient; 11. silicone breast forms patient; 12. chest tumor patient; 13. participant in other clinical trials at the same time.

Keywords: cardiac ischemia
efficacy and safety of salvianolic acid on ais

Conditions: Stroke

Summary: stroke has the characteristics of high morbidity, disability and fatality rate, which brings heavy spiritual and economic burdens to the family, society and the country. in my country, 33%-50% of ischemic strokes are attributed to intracranial atherosclerosis. studies have shown that oxidative stress, increased blood viscosity, and damage to vascular endothelial cells are important mechanisms for the development of cerebral infarction. salvia miltiorrhiza is a commonly used traditional chinese medicine in traditional medicine in my country. salvia miltiorrhiza polyphenolic acid is the effective ingredient of salvia miltiorrhiza. it is the water-soluble active part of salvia miltiorrhiza. it can resist oxidation, anticoagulation, antiplatelet, cell protection, and expand blood vessels, thereby achieving protection cardiovascular system. the purpose of this study was to evaluate the effects and adverse effects of salvianolic acid on acute ischemic stroke onset within 72 hours, and to evaluate the improvement of patients' ischemic area perfusion and clinical function scores.


Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke with the first onset, or a history of cerebral infarction but with a modified rankin scale (mrs) score ≤1, onset within 72h; 2. ct examination to rule out cerebral hemorrhage; 3. with clear signs of nervous system positioning, the national institutes of health stroke scale (nihss) score ≥ 4 exclusion criteria: 1. diseases with bleeding tendency; 2. liver and kidney dysfunction; 3. malignant tumors or those undergoing anti-tumor treatment; 4. allergic physique, allergic to aspirin or salvianolic acid; 5. heart failure, multiple system failure; 6. pregnant or breastfeeding women

Keywords: stroke, ischemic, acute
effect of simvastatin on pneumonia prognosis in elderly patients

Conditions: Community-Acquired Pneumonia

Summary: the objective is to assess the effect of simvastatin on immunology, inflammatory, and coagulation responses, and mortality in elderly with pneumonia based. the primary outcome is mortality event. the hypothesis of this study is that simvastatin therapy will reduce mortality in elderly with pneumonia.

elderly patients diagnosed with pneumonia after getting information and signing informed consent will be included in this trial. simvastatin 20 mg will be administered to intervention group, while control group will receive placebo. both groups will receive drugs (or placebo) for 30 days. baseline data will be collected within 24 hours after admission. then the subject will be followed up for 30 days. at the 7th day, patients will be underwent several laboratory tests, i.e. serum tnf-α (tumor necrosis factor alpha), ifn-ϒ interferon gamma), crp (c-reactive protein), and pai-1 (plasminogen activator inhibitor-1). death from all causes until 30 days will be recorded.

Eligibility criteria:
inclusion criteria: * elderly patients with pneumonia exclusion criteria: * severe septic condition * hepatic cirrhosis * acute coronary disease * total cholesterol which is too high or too low * in anticoagulant therapy * in steroid therapy or other immunosuppressant therapy * have refused to join the study

Keywords: simvastatin pneumonia elderly tnf-α ifn-ϒ pai-1 crp
ql0911 for the treatment of cancer treatment-induced thrombocytopenia

Conditions: Cancer Treatment-Induced Thrombocytopenia

Summary: to evaluate the efficacy and safety of ql0911 in cancer treatment-induced thrombocytopenia. thrombocytopenia is a low number of platelets in the blood. sometimes, thrombocytopenia is a side effect of cancer treatment.


Eligibility criteria:
inclusion criteria: * men and women, 18-75 years of age; * histopathological or cytological examination confirmed cancer , chemotherapy cycle of 21 days; * participant experienced thrombocytopenia and chemotherapy delay; * ecog performance status 0-1; * the estimated survival time at screening is ≥12 weeks, and the current chemotherapy regimen can be accepted for at least 2 cycles. exclusion criteria: * participant has any history of hematologic diseases other than chemotherapy-induced thrombocytopenia; * participant has serious bleeding symptoms; * history of allergy to the study drug; * patients with hepatitis c antibody positive and detection of hcv-rna exceeding the upper limit, patients with hepatitis b surface antigen positive and detection of hbv-dna exceeding the upper limit, patients with severe cirrhosis, hiv antibody positive and syphilis antibody positive; * pregnant or lactating women; * participant has received any experimental therapy within 28 days prior to screening * other conditions that may affect participant's safety or trial evaluations per investigator's discretion
mobile health application to improve hiv medication adherence

Conditions: HIV; Medication Adherence; Mobile Health

Summary: inadequate adherence to antiretroviral therapy (art) can impede successful viral suppression and consequently lead to negative health consequences. this study aims to refine and test the efficacy of a mobile health art adherence application (artaa), delivered over a smartphone, with helping individuals improve their art adherence.

the cdc estimates that 1.1 million people living in the u.s. are infected with hiv \[1\]. only a quarter of person living with hiv (plwh) successfully keep the virus under control \[2\]. medication non-adherence is a significant contributor to unsuccessful viral suppression; a recent meta-analysis found that only an estimated 59% of participants in north american studies were adherent at a commonly accepted minimal threshold for successful viral suppression \[3\]. while newer antiretroviral therapy (art) medications can produce viral suppression at lower levels of adherence, relatively high adherence is still necessary to avoid disease progression and shortened lifespan \[4-6\]. in addition, low levels of adherence increase the risk of infecting others and contribute to the development of treatment resistant strains of hiv \[7;8\]. interventions have been developed to address the significant public health problem presented by poor adherence, with most studies demonstrating some degree of success in the short-term \[9\]. however, the impact of the interventions is generally not sustained over time \[9\], and most hiv treatment settings do not have the resources to deliver more intensive interventions. as a result, there has been interest in developing efficacious electronically-delivered interventions. very little research has focused on establishing the efficacy of mobile health applications for art adherence. further, no published studies have examined a single session face-to-face intervention combined with a mobile application and coaching support to reinforce sustained adherence. delivered over a smartphone, portable applications would allow for real-time adherence tracking and feedback and ready access to content or services to enhance adherence. the long-term goal of this line of research is to disseminate an efficacious, mobile health art adherence application that can be integrated readily into clinical care. the objective of this application is to develop a mobile health art adherence application, to pilot the application, and to conduct a preliminary randomized controlled trial of the application.

Eligibility criteria:
inclusion criteria: * prescribed art, infected with hiv, have a detectable viral load (\>20 copies/ml) with the past 6 months, report less than 100% medication adherence, and have a smart phone capable of downloading the martaa application. exclusion criteria: * physical impairments that prevent completion of the intervention, cognitive impairments that jeopardize informed consent and/or intervention comprehension, active psychosis, and not fluent in english.

Keywords: hiv medication adherence mobile health