Kornimate/medical-research-clean huggingface dataset:
a study of shr-1826 for injection in combination with other antitumor therapies in subjects with solid tumors

Conditions: Advanced Solid Tumors

Summary: this is an open label, multi-center, multiple dose phase ib/ii study to evaluate the safety, tolerability and efficacy of shr-1826 for injection in subjects with advanced solid tumors.


Eligibility criteria:
inclusion criteria: 1. voluntary participation and written informed consent; 2. 18-75 years older, no gender limitation; 3. eastern cooperative oncology group (ecog) score: 0-1; 4. with a life expectancy ≥ 3 months; 5. pathologically diagnosed advanced solid tumor; 6. be able to provide fresh or archived tumour tissue; 7. at least one measurable lesion according to recist v1.1; 8. adequate bone marrow reserve and organ function; 9. contraception is required during clinical trials, and pregnancy tests must be negative for women of childbearing age within 7 days before the first dose. exclusion criteria: 1. meningeal metastasis history or clinical symptoms of central nervous system metastasis; 2. previous or co-existing malignancies; 3. spinal cord compression that was not treated radically by surgery and/or radiotherapy was excluded; 4. uncontrollable tumor-related pain; 5. previously received antiboy-coupled drug therapy with topoisomerase i inhibitor toxin; previously received egfr/c-met double antibody; 6. received systemic antitumor therapy before the first dose; 7. have undergone major surgery other than diagnosis or biopsy within 28 days prior to initial dosing; minor traumatic surgery within 7 days prior to first dosing; 8. for the first time, a study was conducted to treat patients with radiation therapy exceeding the prescribed dose before study treatment; 9. received other investigational drugs treatments 4 weeks prior to the initiation of the study treatment; 10. unresolved ctcae 5.0\>grade 2 toxicities from previous anticancer therapy; 11. a history of interstitial pneumonia/non-infectious pneumonia; 12. accompanied by uncontrolled pleural effusion and pericardial effusion; moderate or severe ascites with clinical symptoms; 13. study the presence of intestinal obstruction or the presence of signs or symptoms of intestinal obstruction 6 months before first dosing; 14. with poorly controlled or severe cardiovascular disease; 15. active hepatitis b, hepatitis c; 16. patients with a history of immunodeficiency; 17. severe infection 30 days before the first dose.
periacetabular osteotomy.a prospective study with reference to cartilage, migration and bone density

Conditions: Osteoarthritis

Summary: the purpose of this study is to evaluate the effect of performing a periacetabular osteotomy on patients with hip dysplasia.

the cause of osteoarthritis in hip dysplasia is thought to be attributable to increased joint contact pressures secondary to decreased acetabular coverage of the femoral head and/or incongruity of the articular surfaces. the investigators' hypothesis is that when periacetabular osteotomy is performed and contact pressure on cartilage reduced, additional joint degeneration will be slowed or prevented unless irreparable damage to the cartilage has happened at the time periacetabular osteotomy is performed. hence, the purposes of this study are: * to develop an unbiased and precise method for measurement of the thickness of the articular cartilage in the hip joint because such a method can be used to evaluate the effect of periacetabular osteotomy and also to give a more precise indication/contraindication for surgery; * to evaluate the migration of the acetabulum postoperatively and 6 months after surgery by use of rsa to examine the stability of the osteotomy; and * to examine bone mineral density in acetabulum 1 and 2 years after surgery in order to find out whether the change in load distribution will affect bone density of the acetabulum over time in a way that in the area where more load is applied, bone density will increase, and in areas with less load, bone density will decrease; * to examine the labrum in the hip joint.

Eligibility criteria:
inclusion criteria: * patients with radiologically diagnosed hip dysplasia (ce-angle \< 25°) * patients with osteoarthritis graded 0, 1 or 2 defined according to tönnis' classification * patients with pain from hip * age \> 18 years * minimum 110° flexion in hip joint and closed growth zones in the pelvic region * informed consent exclusion criteria: * patients with neurological diseases * patients with calvé-legg-perthes syndrome * patients where a femoral intertrochanteric osteotomy is necessary * patients with medical sequelae after earlier hip surgery * females who are pregnant * patients with metal implants

Keywords: cartilage thickness rsa dexa ultra sound mri osteoarthritis periacetabular osteotomy
use of low-cost molecular diagnostic techniques as a new surveillance model for diseases preventable by vaccinations.

Conditions: Bacterial Infections

Summary: vaccine-preventable disease (vpd) surveillance should be a priority throughout the world. in italy, however, there is limited attention to the epidemiology of vpds, with the consequence that their incidence is largely underestimated. although notification of vaccine-preventable diseases is mandatory, very often the etiologic agents causing vpds are not identified the etiological agents causing the major and most severe infectious diseases in childhood. several reasons underlie the underestimation. for example, not having a good surveillance system does not allow us to organize a sustainable prevention project for example based on on the introduction of new vaccinations. for example the limited use of low-cost high-sensitivity techniques such as real-time pcr, which could, if more widely used, improve pathogen identification with 3 times the sensitivity of standard cultural methods. therefore, the idea of this multicenter, biological sample study is to take advantage of the regional pediatric network with the goal of improving vpd surveillance and increase awareness of the importance of surveillance of preventable diseases with the vaccine within the pediatric network.


Eligibility criteria:
inclusion criteria: * subjects aged 0-18 years with infectious disease (bacterial or viral) diagnosed by molecular techniques at the aou meyer immunology laboratory * obtaining informed consent exclusion criteria: * individuals with concomitant diseases such as cystic fibrosis, known immunodeficiency, or with infection suspected nosocomial (hospitalization or hospital admission within 15 days prior to the onset of symptoms) will be excluded from the study
comparison of post-dilution on-line hemodiafiltration and hemodialysis

Conditions: End-Stage Renal Disease

Summary: this study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications. the investigators hypothesize that high-efficiency post-dilution on-line hemodiafiltration may provide better outcome, less morbidity, higher quality of life, and lesser requirement of medications.

the proposed controlled, randomized study aims to compare high-efficiency post-dilution on-line hemodiafiltration and high-flux hemodialysis regarding mortality, hospitalization rate, several clinical and laboratory parameters, and required medications. seven hundred and eighty hd patients will be taken into the study. the study will last for two years with an intermediate analysis at the first year. the patients will be randomly placed in two groups: 1. post-dilution on-line hemodiafiltration, 2. high-flux hemodialysis. in both groups, fx series high-flux helixone membranes will be used, duration of each session 240 minutes, and blood flow rates 250-400 ml/min. onlineplus integrated fresenius 4008s machines will be used for on-line post-dilution hdf. substitution volume will be above 15 liters in hemodiafiltration sessions. echocardiography for determination of left ventricular geometry, pulse wave velocity analysis to assess arterial stiffness, evaluation of nutritional and inflammatory state, assessment of life quality, depression and cost analysis will be performed.

Eligibility criteria:
inclusion criteria: * older than 18 years * on maintenance bicarbonate hd scheduled thrice weekly 12 hours/week,achieved mean single pool kt/v above 1.2 * willingness to participate in the study with a written informed consent exclusion criteria: * to be scheduled for living donor renal transplantation * to have serious life-limiting co-morbid situations, namely active malignancy, active infection, end-stage cardiac, pulmonary, or hepatic disease * pregnancy or lactating * current requirement for hd more than three times per week due to medical comorbidity * gfr greater than 10 ml/min/1.73 m2 as measured by the average of urea and creatinine clearances obtained from a urine collection of at least 24 hours * use of temporary catheter * insufficient vascular access (blood flow rate lower than 250 ml/min) * mental incompetence

Keywords: end-stage renal disease hemodialysis cardiovascular morbidity and mortality high flux dialyser on-line hemodiafiltration arterial stiffness inflammation life quality left ventricular hypertrophy
tailoring screening, brief intervention, and referral to treatment for medical icu survivors

Conditions: Unhealthy Alcohol Use; Alcohol Use Disorders

Summary: unhealthy alcohol use is present in up to 38% of the 4 million patients admitted to an american intensive care unit (icu) each year in the us. despite the high prevalence of unhealthy alcohol use in icu survivors, routine interventions targeted at reducing alcohol consumption, alcohol-related consequences, and illness related to alcohol are not currently part of the multidisciplinary approach to critical care. although screening, brief intervention, and referral to treatment (sbirt) has been described in several healthcare settings, it fails to address common characteristics of medical icu survivors including high rates of alcohol use disorders, cognitive dysfunction, psychiatric comorbidities, and intimate involvement of friends and family. this study uses a qualitative approach to further understand the needs of medical icu survivors with unhealthy alcohol use. the investigators hypothesize that there are common, modifiable barriers to improving alcohol-related outcomes


Eligibility criteria:
inclusion criteria: * 18 years or older * admitted to the medical icu * resolution of critical illness * resolution of delirium/agitation * audit score 8 or greater for men, 5 or greater for women exclusion criteria: * unable to provide informed consent * prisoner * unable to speak or write in english * pregnant

Keywords: unhealthy alcohol use icu survivors alcohol use disorder sbirt screening, brief intervention, and referral to treatment
a trial to assess the effects of prazosin or propranolol on blood pressure in the presence of brexpiprazole/sertraline

Conditions: Post-traumatic Stress Disorder (PTSD)

Summary: a trial to assess the effects of prazosin or propranolol on blood pressure in the presence of brexpiprazole/sertraline


Eligibility criteria:
inclusion criteria: * primary diagnostic and statistical manual of mental disorders (dsm), fifth edition criteria diagnosis of major depressive disorder, post-traumatic stress disorder, generalized anxiety disorder, panic disorder, social anxiety disorder or obsessive-compulsive disorder * must be able to receive a sertraline dose of 150 mg/day by the second screening visit (day -15) exclusion criteria * sexually active males or females, who could become pregnant, not agreeing to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days at the end of the study * diagnosed hypertension (including treated or untreated hypertension), or orthostatic hypotension * epilepsy or a history of seizures * history of neuroleptic malignant syndrome or serotonin syndrome. * primary dsm-5 diagnosis of schizophrenia spectrum and other psychotic disorders, bipolar and related disorders, feeding and eating disorders (including anorexia nervosa or bulimia), neurocognitive disorders (including but not limited to delirium, major or mild neurocognitive disorder due to alzheimer's, parkinson's, or traumatic brain injury) * a significant risk of committing violent acts, serious self-harm, or suicide * history of diabetes mellitus (type 1 or type 2) * subjects with any previous exposure to brexpiprazole, or subjects with chronic use of prazosin or propranolol in the 90 days prior to the screening visit or any use in the 21 days (3 weeks) prior to the screening visit.

Keywords: major depressive disorder (mdd) post-traumatic stress disorder (ptsd) generalized anxiety disorder (gad) panic disorder social anxiety disorder (sad) obsessive-compulsive disorder (ocd) mental disorders
clinical outcome of patients with low-gradient severe aortic stenosis

Conditions: Aortic Stenosis

Summary: to assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with low-gradient, severe aortic stenosis. to assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with low-gradient, severe aortic stenosis. to assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of as severity and definition of low gradient severe aortic stenosis.

to assess the ability of baseline clinical parameters and imaging modalities to predict short and long term left ventricular function and clinical outcome of subjects with impaired left ventricular function and / or low-gradient, severe aortic stenosis. to assess the impact of aortic valve replacement as compared to medical therapy on clinical outcome of patients with impaired left ventricular function and / or low-gradient, severe aortic stenosis. to assess possible impact of aortic annulus assessment using 3-dimensional imaging modalities on the assessment of as severity and definition of low gradient severe aortic stenosis.

Eligibility criteria:
inclusion criteria: 1. severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 and low gradient (mean gradient across the aortic valve \<40 mmhg) by echocardiography 2. symptomatic patients with aortic stenosis referred for medically indicated avr 3. signed informed consent to participate in the study. exclusion criteria: 1. pregnancy or breast feeding (women of childbearing potential will have a serum or urine pregnancy test). 2. need for emergency surgery for any reason. 3. any case in which the practicing physician asserts that enrollment in the protocol will adversely affect the patient treatment course.
evaluation of resectability of pancreatic cancer using low kvp ct

Conditions: Diagnoses Disease

Summary: the aim of this study is to investigate usefulness of low kvp high mas computed tomography in evaluation of pancreatic cancer resectability.


Eligibility criteria:
inclusion criteria: * 1. age between 20 year-old and 85 year-old 2. patient with pancreatic cancer detected on standard ct scan using 120 kvp that obtained within one month 3. consider surgical resection for pancreatic cancer treatment 4. patients who can undergo contrast enhanced ct scan exclusion criteria: * 1. history of severe adverse reaction to iodine contrast 2. less than 60 of estimated gfr
a multicenter, placebo-controlled, double-blind investigative extension trial of the safety and efficacy of aripiprazole in the treatment of patients with bipolar disorder experiencing a manic or mixed episode

Conditions: Bipolar I Disorder

Summary: to investigate the safety and efficacy of long-term administration of aripiprazole by performing extended administration of the treatment administered in the preceding multicenter, double-blind, placebo-controlled, parallel group-comparison trial of aripiprazole in patients with bipolar disorder experiencing a manic or mixed episode (study 031-06-003, hereafter "study 003") in a double-blind manner to those patients who complete study 003 and demonstrate drug efficacy.


Eligibility criteria:
inclusion criteria: * trial subjects will be men and women of age 18 or above and below the age of 65 who will not be turning 65 during the trial. * subjects have the ability to understand and to provide informed consent to the examination, observation, and evaluation processes specified in this protocol, and have signed the informed consent form based on a full understanding of the trial. * subjects who meet dsm-iv-tr criteria for manic or mixed episodes and have been diagnosed as having "296.4x bipolar i disorder in which the most recent episode was manic" or "296.6x bipolar i disorder in which the most recent episode was mixed" * subjects who were enrolled in and have completed study 003 and who meet the following criteria for demonstration of drug efficacy * subjects demonstrating drug efficacy: * those subjects who completed study 003 whose score for cgi-bp change from preceding phase (mania) at the time of evaluation on day 21 of study 003 (completion) was between 1 (very much improved) and 3 (minimally improved) exclusion criteria: * subjects presenting with a clinical picture and/or history that is consistent with a dsm-iv-tr diagnosis of: * delirium, dementia, amnestic disorder, or other cognitive disorders * schizophrenia or other psychotic disorder * personality disorder * subjects with psychotic symptoms that are clearly due to another general medical condition or direct physiological effects of a substance * subjects who represent a significant risk of committing suicide * subjects known to have a complication of allergy to aripiprazole or other quinolinone-skeleton compounds * subjects with a complication of neuroleptic malignant syndrome * subjects in a state of physical exhaustion accompanied by such conditions as dehydration or malnutrition * subjects with a complication of paralytic ileus * subjects with a complication of organic brain disorder or convulsive disorder, such as epilepsy * subjects with a complication of diabetes
effect of inhalation aromatherapy on anxiety and depressive symptoms of geriatric patients with parkinson's disease

Conditions: Inhalation Aromatherapy

Summary: the present study aims to: investigate the effect of inhalation aromatherapy on anxiety and depressive symptoms of geriatric patients with parkinson's disease. research hypothesis: patients with parkinson's disease who inhale aromatherapy will exhibit lower anxiety and depressive symptoms than those who didn't inhale it

a sample of 60 randomly selected patients with patients parkinson's disease was included in this study. the study subjects were divided equally into two groups; study (30 patients) and a control group (30 patients) matched as much as possible. exclusion criteria included patients diagnosed for parkinson's by a specialist, no use of any complementary alternative medicine methods (herbal medicines and other methods) in the past one week, no use of anxiolytics or antidepressants drugs, no history of respiratory problems as asthma, eczema and allergies to flowers and plants and no smell disorders. patients who were not willing to participate, not able to provide written consent or not able to communicate coherently and relevantly or showed symptoms of allergy to lavender were excluded from the study.

Eligibility criteria:
inclusion criteria: patients diagnosed for parkinson's by a specialist exclusion criteria: no use of any complementary alternative medicine methods (herbal medicines and other methods) in the past one week, no use of anxiolytics or antidepressants drugs, no history of respiratory problems as asthma, eczema and allergies to flowers and plants and no smell disorders. patients who were not willing to participate, not able to provide written consent or not able to communicate coherently and relevantly or showed symptoms of allergy to lavender will be excluded from the study.

Keywords: inhalation aromathrapy, anxiety, depressive symptoms, parkinson's disease
significance of mrd monitoring in patients with potentially resectable stage iii non-small cell lung cancer

Conditions: NSCLC

Summary: stratification of postoperative ctdna status can effectively assess the risk of recurrence in patients. in addition, the multi-node dynamic monitoring of ctdna is more effective in predicting the recurrence risk of patients. in this study, egfr/alk negative potentially resectable stage iii non-small cell lung cancer were enrolled. baseline tissues, peripheral blood samples of patients at baseline puncture tissue, after neoadjuvant therapy, after surgery (if any), after adjuvant therapy, and at multiple nodes during follow-up were collected for 1021-mrd analysis through tumor-informed personalized monitoring mrd test kit. this study aim to explore mrd biomarker in patients with potentially resectable stage iii non-small cell lung cancer.

in this prospective study, 65 patients with potentially operable non-small cell lung cancer without driving gene egfr/alk mutation in stage iii were enrolled in this prospective study. peripheral blood samples from multiple nodes after neoadjuvant therapy, postoperative (if any), adjuvant therapy and follow-up were collected and analyzed by high-throughput sequencing in the target region. patients were enrolled in the study for 1 year, followed up for 2 years, and the study lasted for 3 years. the patients were followed up for 2 years according to the standard diagnosis and treatment path, with a total of 9 times of follow-up, all of which were 3-month follow-up plan of the standard diagnosis and treatment path, and the follow-up examination was conducted in accordance with clinical standards.

Eligibility criteria:
inclusion criteria: 1. capable of giving signed informed consent, age ≥ 18 and ≤ 80. 2. patients with stage ⅲ non-small cell lung cancer confirmed by histology or cytology have potential surgical opportunities. 3. no driving gene egfr/alk mutation. 4. ps = 0-1. 5. the treatment process cooperated with the provision of clinicopathological and imaging data needed in the research process, followed up and collected the blood of the clinical efficacy evaluation nodes, and agreed to use the test data for follow-up research and product development. exclusion criteria: 1. patients suffering from other malignant tumors. 2. patients change the treatment regimen before receiving the specified treatment or before the disease progresses. 3. patients could not cooperate with the study for follow-up according to the defined clinical follow-up period; 4. patients were unable to accept or provide imaging and other designated therapeutic evaluation means.

Keywords: mrd, potentially resectable nsclc, stage iii