Kornimate/medical-research-clean huggingface dataset:
development of a multi-omics prediction model for immunotherapy response in triple-negative breast cancer subtypes

Conditions: Breast Neoplasms

Summary: this study aims to collect clinical samples from breast cancer patients who have undergone or are expected to undergo immunotherapy at our institution. the samples, including fresh tissue from diagnostic punctures, residual tumor tissue post-surgery, blood samples, and imaging data, will be used to build a predictive model for immunotherapy efficacy. the research will employ proteomics, transcriptomics, metabolomics sequencing, imaging mass cytometry (imc), and spatial transcriptomics to construct a multi-omics, multi-dimensional (temporal and spatial) model to predict the effectiveness of immunotherapy.

this research will utilize a comprehensive approach by analyzing various types of clinical samples from breast cancer patients treated with immunotherapy. the integration of proteomic, transcriptomic, and metabolomic data, along with advanced imaging techniques like imc and spatial transcriptomics, will allow for a detailed understanding of the tumor microenvironment and its response to immunotherapy. this multi-dimensional analysis aims to enhance the accuracy of predicting immunotherapy outcomes, thereby aiding in personalized treatment strategies for breast cancer patients. the study adheres strictly to ethical guidelines, ensuring patient confidentiality and welfare are maintained throughout the research process.

Eligibility criteria:
inclusion criteria: - female, aged ≥ 18 years. pathologically confirmed diagnosis of breast cancer. patients who received immunotherapy/neoadjuvant immunotherapy at our institution between january 1, 2015, and september 30, 2023 (retrospective cohort), or patients who may receive immunotherapy/neoadjuvant immunotherapy starting from october 1, 2023 (prospective cohort). availability of sufficient tumor tissue samples (e.g., fresh biopsy tissue, residual tumor tissue post-surgery). availability of blood samples and imaging data. signed informed consent (for the prospective cohort). exclusion criteria: * male breast cancer patients. inability to provide sufficient tumor tissue samples or other clinical data. presence of severe comorbidities (e.g., active infections, severe cardiac, hepatic, or renal dysfunction) that may affect the safety assessment of immunotherapy. lack of signed informed consent (for the prospective cohort).
effects of tai chi on frailty in elderly adults

Conditions: Frailty

Summary: the aim of this study is determine the effects of tai chi exercise, as compared to an education-based control intervention, on cardiovascular and balance system function in older people at risk of developing frailty. we hypothesize that long-term tai chi training will improve specific nonlinear properties associated of cardiovascular and balance dynamics in this population.


Eligibility criteria:
inclusion criteria: * men and women over age 70 will be included if they are able to stand and walk unassisted, are free of any acute or unstable medical conditions, and are able to understand directions and participate in the protocol. exclusion criteria: * potential subjects will be excluded 1) if they cannot stand and ambulate unassisted, 2) are experiencing any symptomatic cardiovascular or respiratory disease, or have 3) a myocardial infarction or stroke within 6 months, 4) painful arthritis, spinal stenosis, amputation, painful foot lesions, or neuropathy that limits balance and mobility, 5) systolic bp above 160 or diastolic bp above 100 mm hg, 6) a cardiac pacemaker, 7) parkinson's disease or other neuromuscular disorder, 8) metastatic cancer or immunosuppressive therapy, or 9) have significant visual impairment.
an efficacy and safety study of a combination of jnj-73763989, nucleos(t)ide analogs (na), and a programmed cell death protein receptor-1 (pd-1) inhibitor in chronic hepatitis b participants

Conditions: Hepatitis B, Chronic

Summary: the purpose of this study is to evaluate efficacy of the study intervention, based on hepatitis b surface antigen (hbsag) levels at follow-up (fu) week 24.

jnj-73763989 (jnj-3989) is a small interfering ribonucleic acid (sirna) targeting all hepatitis b virus (hbv) messenger ribonucleic acid (mrnas). the programmed cell death protein receptor-1 (pd-1) inhibitor aims at preventing the interaction of pd-1 with its ligands. the purpose of this study to determine whether at least one of the combination regimens of jnj-3989 + pd-1 inhibitor + nucleos(t)ide analog (na) is more efficacious than jnj-3989 + na treatment. this study will be conducted in 3 periods: screening period, treatment period and follow-up (fu) period. safety assessments will include adverse events (aes), serious aes, clinical safety laboratory tests, electrocardiograms (ecgs), vital signs, and physical examinations. total duration of individual participation will be up to 78 weeks (including screening period).

Eligibility criteria:
inclusion criteria: * participants must have chronic hepatitis b virus (hbv) infection * participants must have fibroscan liver stiffness measurement less than or equal to (\<=) 9.0 kilopascal (kpa) or a liver biopsy result classified as metavir f0-f2 exclusion criteria: * participants with evidence of hepatitis a virus infection (hepatitis a antibody immunoglobulin igm), hepatitis c virus (hcv) infection (hcv antibody), hepatitis d virus (hdv) infection (hdv antibody), hepatitis e virus (hev) infection (hepatitis e antibody igm), or human immunodeficiency virus type 1 (hiv-1) or human immunodeficiency virus type 2 (hiv-2) infection (laboratory confirmed) at screening * history or evidence of clinical signs or symptoms of hepatic decompensation, including but not limited to portal hypertension, ascites, hepatic encephalopathy, esophageal varices * participants with history or signs of cirrhosis or portal hypertension or signs of hepatocellular carcinoma (hcc) or clinically relevant renal abnormalities * participants with personal/familial history/indicative of immune-mediated disease risk
prasugrel versus placebo in adult sickle cell disease

Conditions: Sickle Cell Anemia

Summary: the purpose of this trial is to assess the safety of prasugrel in adult patients with sickle cell disease (scd) by monitoring the rate and severity of hemorrhagic events requiring medical intervention compared to placebo for 30 days.


Eligibility criteria:
inclusion criteria: * adults with sickle cell disease (scd). * are greater than or equal to 50 kilograms (kg) at time of screening. * are not currently being treated with an investigational drug (use of hydroxyurea, which is not an investigational drug, is permitted under this protocol if the patient has been on a stable dose for at least 30 days prior to randomization and has no signs of hematological toxicity at screening. * agree to use a reliable method of birth control during the study or are women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause. exclusion criteria: * acute painful crisis (requiring medical attention) within 30 days prior to screening. * have a concomitant medical illness (for example, terminal malignancy) that, in the opinion of the investigator, is associated with reduced survival over the expected treatment period (approximately 30 days). * severe hepatic dysfunction (cirrhosis, portal hypertension, or aspartate aminotransferase (ast) greater than or equal to 3x upper limit of normal \[uln\]). * renal dysfunction requiring chronic dialysis. * contraindication for antiplatelet therapy. * history of intolerance or allergy to approved thienopyridines. * have signs or symptoms of an infection. * hypertension (systolic blood pressure \>180 millimeters of mercury (mm hg) or diastolic blood pressure \>110 mm hg) at the time of screening or randomization. * hematocrit \<18%. * any history of bleeding diathesis, bleeding requiring in-hospital treatment, or papillary necrosis. * active internal bleeding. * history of spontaneous gastrointestinal (gi) bleeding requiring in-hospital treatment. * gross hematuria. microhematuria, common in scd patients, is not a contraindication. * platelet count \<100,000 per cubic millimeter. * any history of intraocular hemorrhage. * prior history of transient ischemic attack (tia), ischemic stroke, hemorrhagic stroke, or other intracranial hemorrhage. * known history of intracranial neoplasm, arteriovenous malformation, or aneurysm. * have clinical findings, in the judgment of the investigator, associated with an increased risk of bleeding. * have an international normalized ratio (inr) of greater than 1.5 at screening. * have had recent surgery (within 30 days prior to screening) or are scheduled to undergo surgery within the next 60 days. * history of menorrhagia requiring medical intervention.

Keywords: sickle cell disease sickle cell anemia adult
analysis of sleep & recovery following rotator cuff repair surgery

Conditions: Rotator Cuff Tears; Rotator Cuff Injuries; Shoulder Pain; Shoulder Injuries; Shoulder Impingement

Summary: postoperative recovery following a rotator cuff repair surgery can be challenging. in particular, sleeping is difficult given the restrictions of the operative shoulder. this study aims to evaluate a postoperative sleep device that will allow for safe and comfortable positioning of the arm, with the anticipated effect to improve postoperative recovery and sleep.

postoperative recovery following a rotator cuff repair surgery can be challenging. in particular, sleeping is difficult given the restrictions of the operative shoulder. this study aims to evaluate a postoperative sleep device that will allow for safe and comfortable positioning of the arm, with the anticipated effect to improve postoperative recovery and sleep.

Eligibility criteria:
inclusion criteria: * rotator cuff tear exclusion criteria: * prior ipsilateral shoulder surgery * ipsilateral upper extremity neurological deficit
trial of neoadjuvant intensity-modulated radiation therapy followed by surgery and intraoperative radiation therapy in resectable retroperitoneal soft tissue sarcoma (retro-wts)

Conditions: Retroperitoneal Soft Tissue Sarcoma

Summary: local control rates in patients with retroperitoneal soft tissue sarcoma (rsts) remain disappointing even after gross total resection, mainly because wide margins are not achievable in the majority of patients. in contrast to extremity sarcoma, postoperative radiation therapy (rt) has shown limited efficacy due to its limitations in achievable dose and coverage. although intraoperative radiation therapy (iort) has been introduced in some centers to overcome these dose limitations and resulted in improved outcome, local failure rates are still high even if considerable treatment related toxicity is accepted. as postoperative administration of rt has some general disadvantages, neoadjuvant approaches could offer benefits in terms of dose escalation, target coverage and reduction of toxicity, especially if highly conformal techniques like intensity-modulated radiation therapy (imrt) are considered. therefore the retrowts trials has been designed as a prospective, one armed, single center phase i/ii study investigating a combination of neoadjuvant dose-escalated imrt (50-56 gy) followed by surgery and iort (10-12 gy) in patients with at least marginally resectable rsts. the primary objective is the local control rate after five years. secondary endpoints are progression-free and overall survival, acute and late toxicity, surgical resectability and patterns of failure. the aim of accrual is 37 patients in the per-protocol population.


Eligibility criteria:
inclusion criteria: * written informed consent * histologically confirmed, primary or locally recurrent soft tissue sarcoma of the retroperitoneal space * judged as at least marginally resectable * absence of distant metastases * tumor size ≥ 5 cm exclusion criteria: * missing written informed consent * missing histological confirmation of soft tissue sarcoma * desmoid tumor (syn. aggressive fibromatosis) * judged as gross incomplete or not resectable * incomplete staging * presence of distant metastases * prior radiation therapy to the abdominal region * participation in another clinical interventional study * inflammatory bowel disease

Keywords: retroperitoneal soft tissue sarcoma imrt iort
feasibility of the portable yougrabber system

Conditions: Cerebral Palsy; Stroke; Traumatic Brain Injury; Meningomyelocele; Central Nervous System Diseases

Summary: the aim of the study is to determine the feasibility of the portable version of the yougrabber® system in children with central motor disorders.

in a feasibility trial with the portable version of the yougrabber® system it will be determined if the technique and equipment are ready to be used in a home setting where children with central motor disorders train with assistance of caregivers but without a therapist. furthermore, it will be examined if children and adolescents with central motor disorders accept this home-based system and if they are motivated for using it.

Eligibility criteria:
inclusion criteria: * central motor disorders * ability to sit in an upright position for 45 minutes exclusion criteria: * manual ability classification scale (macs) v * severe visual or auditory impairments * severe photosensitive epilepsy

Keywords: children rehabilitation telerehabilitation upper limb therapy
aquacel compared to traditional post surgical wound dressing in vascular surgery patients

Conditions: Wound Healing; Patient Comfort

Summary: the study is a prospective randomised, controlled study of 136 patients undergoing vascular surgery. their closed wounds were covered with either aquacel, a hydrofiber dressing, or a traditional gauze dressing.number of changes, patient comfort,number of infections, length of hospital stay and wound complications were compared between the two groups.


Eligibility criteria:
inclusion criteria: * patients undergoing elective vascular surgery, with an expected hospital stay of at least 4 days. informed consent exclusion criteria: * known hypersensitivity to the dressing materials. age under 18 years. dementia, insufficient danish language understanding, pregnancy

Keywords: patient comfort wound dressings infection vascular surgery
cohort study in type 2 diabetes in china

Conditions: Type 2 Diabetes

Summary: this study is designed to assess the incidence of cardiovascular events occurred within an 12 month follow up period in type 2 diabetic patients with either high risk of cardiovascular disease (cvd) or history of coronary artery disease (cad) or stroke.

the number of diabetes patients around the world has increased from 30 million in 1985 to the current 180 million, and is expected to grow to 366 million in 2025, with 75 percent occurring in developing countries such as india and china. in china, economic prosperity and changes in diet and lifestyles have resulted in steep increase in prevalence of overweight, obesity, and diabetes. type 2 diabetes mellitus is associated with an increased risk for both micro-and macrovascular complications, and cardiovascular diseases (cvd) are the most common causes of death in these patients. preventing the onset or the worsening of the cardiovascular diseases is thus one of the most important goals in managing type ii diabetes. this study is designed to better understand the incidence of cardiovascular events under current patterns of treatment in type 2 diabetic patients with either 3 or more risk factors for cardiovascular disease such as older age, hypertension, dyslipidemia, etc, or existing or prior history of coronary artery disease and stroke. approximately 1000 patients from major hospitals across several regions of china will be recruited for this study.

Eligibility criteria:
inclusion criteria: * patients who are 40 years of age or older * patients with confirmed diagnosis of type ii diabetes * patients with 3 or more cvd risk factors or with confirmed/history of cad or history of ischemic stroke * patients who have lab data within 30 days of baseline visit * patients who are willing to return for all follow up visits exclusion criteria: * patients who are not willing or not able to return to the same hospital within 12 months after enrollment * patients who have life threatening or terminal disease, or are physically unable to make follow up visits every 6 months after enrollment * patients have severe heart failure (new york heart association \[nyha\] class 3-4) * patients with severe renal deficiency (creatinine clearance less than 30 ml/min) * patients who are not willing to sign informed consent form

Keywords: diabetes cardiovascular disease observational study china
long term follow-up of cervical myelopathy inpatients treated with integrated complementary and alternative medicine

Conditions: Cervical Myelopathy

Summary: model of this study is a combined both retrospective chart review and follow up survey. data of 4 hospitals will be used to find out the efficacy of conservative treatment in cervical myelopathy.

cervical myelopathy is known as its symptoms are progressively worsened, and there are only a small amount of positive outcomes other than surgery. however, as with other spinal and nerve disorders, non-surgical treatments are getting more attention in terms of patient safety, and because they provide patients with more choice in treatment than in terms of surgical treatment, they can provide closer approach to patient-centered care. physical therapy and medication are well known for the currently known non-surgical and conservative treatments, but research reported on the treatment of cervical myelopathy by using korean medicine treatment so far has its weak level. therefore, it is expected that this study will demonstrate the efficacy of the treatment of cervical myelopathy in korean medicine treatment and will further pave the way for non-surgical treatment of spinal myelopathy. therefore, the investigators conducted observational trial to analyze the effectiveness of korean medicine treatment in spinal myelopathy. retrospective data will be extracted using electronic medical records and computerized data of hospitalized patients. based on this, investigators will conduct research in the form of prospective survey and analyze the causal relationship and factors using the two data. the hospital's medical records will be used to analyze the patient's condition during the hospitalization period and to determine the situation after the end of treatment through questionnaire. the questionnaire will be developed after consultation with experts from musculoskeletal system and related societies, and will be used for the questionnaire.

Eligibility criteria:
inclusion criteria: * patients who had been hospitalized with symptoms of neurological defects such as muscle weakness in the upper extremity or sensory abnormalities, or impaired walking due to weakness in the lower extremity at haeundae jaseng korean medicine hospital, jaseng korean medicine hospital, bucheon jaseng korean medicine hospital and incheon jaseng korean medicine hospital from jan 2011 to oct 2018. * patients diagnosed with 'cervical myelopathy' finding and able to check the pressure and damage of the spinal cord (high signal shading) of the emr imaging (t2-weighted mri scan of c-spine) * patients who agreed voluntarily to participate in verbal consent exclusion criteria: * patients whose chief complaint is not cervical myelopathy or who do not have the neurological defect of upper extremity or lower extremity * if the cause of the neurological defect of the upper and lower extremities is not caused by the spine or tissue * patients who do not agree to participate in the study

Keywords: cervical myelopathy korean medicine treatment
letrozole plus ribociclib or placebo as neo-adjuvant therapy in er-positive, her2-negative early breast cancer

Conditions: Breast Cancer

Summary: the purpose of this study is to determine if ribociclib in combination with letrozole for 24 weeks as neoadjuvant endocrine therapy increases the proportion of women with pre-operative endocrine prognostic index (pepi) score of 0 at surgery compared to patients treated with letrozole alone therefore allowing more patients excellent outcomes without chemotherapy.

subjects will be randomized (1:1:1) to either letrozole plus placebo vs. letrozole plus continuous dosing of ribociclib vs. letrozole plus intermittent dosing (3-weeks-on/1-week-off) of ribociclib. the difference in clinical, pathologic and radiologic response as well as pre-operative endocrine prognostic index (pepi) scores across the three treatments arms will be examined. subjects will also be followed for 5 years post-treatment to determine if ribociclib in combination with letrozole for 24 weeks results in improved 5 year relapse free survival (rfs) compared to letrozole alone.

Eligibility criteria:
key inclusion criteria: * pathologically confirmed invasive breast cancer by core needle biopsy * female subjects, age ≥ 18 years * only postmenopausal women will be eligible. * performance status: eastern cooperative oncology group (ecog) score 0-2 * invasive breast cancer must be er+ in ≥66 % of the cells or er allred score 6-8 * invasive breast cancer must be her2 negative. * clinical stage ii or iii (by clinical measurement and/or breast imaging) key exclusion criteria: * subjects meeting any of the exclusion criteria at baseline will be excluded from study participation. * current use of other investigational agents * inflammatory breast cancer defined as clinically significant erythema of the breast and/or documented dermal lymphatic invasion (not direct skin invasion by tumor or peau d'orange without erythema) * an excisional biopsy of this breast cancer * surgical axillary staging procedure prior to study entry * hormone replacement therapy of any type, megestrol acetate, or raloxifene within four weeks prior to first study treatment * clinical or radiographic evidence of metastatic disease * clinically significant, uncontrolled heart disease * herbal preparations/medications as listed in appendix b of the protocol

Keywords: er+, her2-negative breast cancer stage ii or iii letrozole femara ribociclib lee011 neo-adjuvant