Kornimate/medical-research-clean huggingface dataset:
a study of ly573636-sodium in patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: the primary purpose of this study is to determine the objective response rate (complete and partial response) for patients who receive ly573636-sodium for metastatic breast cancer.

patient will receive a 2-hour intravenous infusion of study drug (ly573636-sodium) once every 28 days. radiologic imaging scans will be performed before the first dose of study drug and then after every other treatment. patients will be assessed for clinical progression at every visit and for response approximately every 56 days (every other cycle).

Eligibility criteria:
inclusion criteria: * received at least 2 or more prior chemotherapy regimens for metastatic breast cancer. * have discontinued all previous therapies for cancer, including chemotherapy, radiotherapy, cancer-related hormonal therapy, or other investigational therapy for at least 4 weeks. patients who have received whole-brain radiation must wait 90 days. exclusion criteria: * serious pre-existing medical condition. * have active central nervous system or leptomeningeal metastasis. * current hematologic malignancies, acute or chronic leukemia. * receiving warfarin (coumadin). * have a history of radiation therapy involving more than 25% of the bone marrow.

Keywords: metastatic
effects of pressure-controlled intermittent coronary sinus occlusion (picso) therapy on mirnas expression and absolute microvascular resistance by continuous thermodilution in st-segment elevation myocardial infarction (stemi) patients: picso-stemi trial

Conditions: Anterior Myocardial Infarction

Summary: in this study we pretend to determine the molecular (mirnas expression, angiogenic and inflammatory biomarkers) and microcirculatory (assessed by the innovative continuous intracoronary thermodilution technique) effects of picso compared to a standard pci control group in patients with high-risk anterior stemi. then, we aim to assess the efficacy of these molecular biomarkers as prognostic tools. also, we will evaluate the impact of picso on the coronary microcirculation beyond the acute phase in the follow-up six months after stemi. finally, we will assess picso influence on heart failure (hf) clinical variables and patients' quality of life including a cost-effectiveness assessment in the mid-term follow-up one year after the stemi event.


Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years old. 2. anterior stemi (ecg with persistent elevation ≥ 2 mm (0.2 mv) in 2 or more contiguous anterior precordial leads (v2, v3, v4) in men or ≥ 1.5 mm (0.15 mv) in women. 3. culprit lesion in proximal or mid left anterior descending artery (lad). 4. pre-pci timi flow 0-1. 5. symptoms consistent with myocardial ischemia (persistent chest pain, dyspnea, nauseas/vomiting, fatigue, palpitations or syncope) present for ≤ 12 hours. 6. the patient is eligible for primary pci. 7. informed consent received and signed for study enrollment. exclusion criteria: 1. contraindication to coronary angiogram or pci. 2. implants or foreign bodies in the coronary sinus. 3. known allergies to polyurethanes, polyethylene terephthalate (pet) or stainless steel. 4. known pregnancy or breastfeeding. 5. known coagulopathy. 6. known severe kidney disease (egfr \<=30 ml/min/1.73) and/or hemodialysis. 7. known large pericardial effusion or cardiac tamponade. 8. central hemodynamically relevant left-right shunt. 9. previous mi or coronary artery bypass graft (cabg). 10. previous history of stroke, transient ischemic attack (tia) or reversible ischemic neurological deficit within last 6 months. 11. cardiopulmonary resuscitated (cpr) cardiac arrest ≥ 5 minutes whom baseline neurologic status is not present. 12. unconscious at presentation. 13. need for circulatory support. 14. need for invasive mechanical ventilation. 15. need for temporal intravenous pacemaker. 16. patient not suitable for femoral access. 17. known contraindication for adenosine administration (severe asthma, complicated atrioventricular (av) block, critical aortic stenosis, severe cardiac arrhythmias, severe valve diseases). 18. known epicardial stenosis greater than 50% distal to the culprit lad lesion. 19. active participation in another drug or device investigational trial. 20. medical, social or psychological condition that limits the ability of patient to participate in the study. 21. patients with definite or probable coronavirus disease 19 diagnosis within 2 weeks prior to stemi.
different targeted antibody-drug conjugates for her2 ultra-low or no expression advanced breast cancer（galaxy）

Conditions: Breast Cancer

Summary: this is a phaseⅰb/ⅱ, open-label, two-arm parallel study evaluating the efficacy and safety of different targeted antibody-drug conjugates for her2 ultra-low or no expression advanced breast cancer


Eligibility criteria:
inclusion criteria: ecog performance status of 0 or 1 pathologically documented breast cancer that: 1. is advanced or metastatic 2. is histologically confirmed to be her2 ihc 0 (ish- or untested) 3. was never previously her2-positive (ihc 3+ or ish+) at least one measurable lesion according to response evaluation criteria in solid tumors (recist) criteria version 1.1. disease progression on at least 1 previous line of chemotherapy for recurrent/metastatic breast cancer. subjects with her2-negative and hormone-receptor positive tumors must have progressed after at least 1 line of endocrine therapy with or without cdk4/6 inhibitor. has protocol-defined adequate organ and bone marrow function. ability to understand and willingness to sign a written informed consent document. exclusion criteria: has previously been treated with any anti-her2 therapy. known prior severe hypersensitivity to investigational product or any component in its formulation and other monoclonal antibodies. any major surgery, radiotherapy, chemotherapy, immunotherapy or molecular targeted therapy, biotherapy or other drug clinical trial within 4 weeks; received endocrine therapy within 2 weeks before the first study drug administration. history of other malignancy than breast cancer within 5 years prior to screening (except for cured skin basal cell carcinoma and cervical carcinoma in situ). meningeal metastasis or active brain parenchymal metastasis. any concurrent use of immunosuppressant or systemic corticosteroid treatment to achieve immunosuppression purpose (dose of \> 10mg/day prednisone or equivalent), and still in use within 2 weeks before the first study drug administration. has uncontrolled intercurrent illness or significant cardiovascular disease. history of clinically significant lung diseases. history of immunodeficiency, including hiv positive. known active hepatitis b virus or hepatitis c virus infection. has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study.
fox bionet project: lrrk2-002

Conditions: Parkinson Disease

Summary: the overall objective of this study is to determine whether lrrk2 kinase activity and/or mitochondrial dna (mtdna) damage could serve as potential biomarkers in pd.

primary objectives: * assess the levels of phosphorylated lrrk2 and lrrk2-phosphorylated rabs, as measures of lrrk2 kinase activity, in pbmcs and neutrophils from lrrk2 pd, idiopathic pd, non-manifesting lrrk2 mutation carriers and healthy controls. * assess the levels of mtdna damage in buffy coat from lrrk2 pd, idiopathic pd, non-manifesting lrrk2 mutation carriers and healthy controls. * correlate lrrk2 kinase activity to mtdna damage in blood from lrrk2 pd, idiopathic-pd, non-manifesting lrrk2 mutation carriers and healthy controls. secondary objectives: * to assess the ability of the network to efficiently conduct a study involving biosample collection for pd research. efficiency will be assessed using measures of the time taken to meet specific milestones within the study. * to assess the ability of the network to collect high quality biospecimens adhering to agreed-upon, standardized protocols * to gauge the willingness of participants to participate in subsequent fox bionet studies

Eligibility criteria:
inclusion criteria: lrrk2 parkinson disease (pd) subjects: * patients must have confirmed lrrk2 mutation * patients must meet the mds criteria for parkinson's disease * disease duration: any * male or female age 30 years or older at time of pd diagnosis. idiopathic pd subjects: * patients must meet the mds criteria for parkinson's disease. * disease duration: any * male or female age 30 years or older at time of pd diagnosis. non-manifesting lrrk2 mutation carriers: * patients must have confirmed lrrk2 mutation * male or female age 30 years or older at screening. control (c) subjects: * male or female age 30 years or older at screening. exclusion criteria: lrrk2 parkinson disease (pd) subjects: * inability to provide informed consent * participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans. * treatment for cancer in the last 5 years. idiopathic pd subjects: * inability to provide informed consent * participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans. * treatment for cancer in the last 5 years. non-manifesting lrrk2 mutation carriers: * inability to provide informed consent * participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans. * treatment for cancer in the last 5 years. control subjects: * inability to provide informed consent * participation in a blinded clinical trial of any kind or an unblinded trial of an investigational product that is not currently approved for use in humans. * treatment for cancer in the last 5 years

Keywords: parkinson's disease biomarker lrrk2
does prescriptive treatment of the hips improve outcomes in patients with low back pain? a randomized controlled trial

Conditions: Low Back Pain

Summary: there will be two groups of patients with low back pain (by randomization). both groups will receive a pragmatic treatment approach by physical therapists for low back pain. one group will also receive a prescriptive treatment approach for both hips. the investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

it has been suggested that treatment of the hips should improve outcomes in patients with mechanical low back pain. this has yet to be studied in a randomized controlled fashion or in a conservative venue. for this study, there will be two groups of patients with low back pain (by randomization). for inclusion into the randomized clinical trial, patients will need to be 18 years of age or older with mechanically producible lbp. they will require a minimum modified oswestry disability index score of 20% and a baseline pain score of \>2.0/10 on the numeric analog scale for pain, and a within session change (improvement during the visit) in pain and/or range of motion during the assessment phase of the clinical examination. this finding has been advocated as an effective mechanism to determine if a patient is a candidate for manual therapy. exclusion criteria will include the presence of any red flags (i.e., tumor, metabolic diseases, rheumatoid arthritis, osteoporosis, prolonged history of steroid use, etc.), or signs consistent with nerve root compression (reproduction of low back or leg pain with straight leg raise at less than 45°, muscle weakness involving a major muscle group of the lower extremity, diminished lower extremity muscle stretch reflex, or diminished or absent sensation to pinprick in any lower extremity dermatome). other exclusion criteria include prior surgery to the lumbar spine and current pregnancy. both groups will receive a pragmatic treatment approach by physical therapists for low back pain. one group will also receive a prescriptive treatment approach for both hips. the investigators will track the outcomes of disability (oswestry), pain (numeric pain rating scale), and recovery at baseline, 2 weeks, and discharge. our aims are to determine if differences in groups exist, with our primary outcome measure of odi. the investigators feel that the additional of a standardized exercise program and stretching for the hips will improve outcomes in patients with mechanical low back pain.

Eligibility criteria:
inclusion criteria: * 18 years of age or older * mechanically producible lbp. * minimum modified oswestry disability index score of 20% * minimum baseline pain score of \>2.0/10 on the numeric analog scale for pain exclusion criteria: * presence of any red flags * signs consistent with nerve root compression * prior surgery to the lumbar spine * current pregnancy

Keywords: low back pain, non-specific low back pain
fuzheng nizeng formula for chronic atrophic gastritis with low-grade intraepithelial neoplasia, a multicenter randomized controlled trial

Conditions: Atrophic Gastritis With Low-grade Intraepithelial Neoplasia

Summary: fuzheng nizeng formula (fznz) is derived from the classic formula liujunzi decoction. former pilot study found that fznz promoted the recovery of gastric atrophy and relieve the relative symptoms. this study is to evaluate its efficacy for chronic atrophic gastritis with low-grade intraepithelial neoplasia, compared with positive control molduodan granule.


Eligibility criteria:
inclusion criteria: * chronic atrophic gastritis with low-grade intraepithelial neoplasia diagnosed by endoscopy and stomach biopsy. * helicobacter pylori negative. * tcm syndrome is spleen-stomach deficiency with blood stasis and phelgm. exclusion criteria: * history of gastric surgery. * combined with malignant tumor. * history of mental illness. * allergy to any components of the drug use in the study. * planning to pregnancy, or pregnant woman and lactating woman.

Keywords: atrophic gastritis intraepithelial neoplasia
erythema at exit site & tablet camera

Conditions: CLABSI - Central Line Associated Bloodstream Infection; CRBSI - Catheter Related Bloodstream Infection; Digital Technology

Summary: background: in critical care medicine central venous catheters play an important role in the source of infections. in the daily routine prior to the diagnosis the suspicion of catheter related infection is discussed in the medical team due to signs of systemic inflammation or exit site infection like erythema, induration or tenderness. however, if an erythema at exit site of a central line can be quantified with a tablet camera, is unknown. methods: standardized set of photos will be taken of 10 central lines with a reddened exit site and 10 catheters without an erythema (as a control over time) with a tablet camera and a single-lens reflex camera. the percentage of usable images between tablet and single-lens reflex camera will be analysed. furthermore, two independent clinical experts from dermatology will grade blinded de-identied images on a scale from 0 to 4 (0 - no erythema, 1- very faint, 2 - faint, 3 - bright, 4 - very bright). objectives: the primary objective of this feasibility study aims to analyze the reliability of a tablet camera as a device for quantification of erythema around an exit site.


Eligibility criteria:
inclusion criteria: * adult * jugular cvc or subclavian cvc * icu-admission exclusion criteria: * \< 18 years * pregnancy/lactation * hiv * neutropenia (\<1000/m3) * hematologic tumor * dark pigmentation * prone position within the last 24 hours * head/neck-area: cancer, operation, burns or radiation, tattoos
study on gene evolution in glioma under stress therapy

Conditions: Genetic Change

Summary: little is known about the evolution of genetic and epigenetic changes that occur in the progression of glioma. we inferred the evolution trajectories of matched pairs of primary tumors and progression tumor in situ fluid (tisf) based on deep whole-genome-sequencing data (ctdna). a monocentric, gene grouping controlled trial design was used to select patients. and to compare gene evolution of different subtypes of glioma under therapy. to predict the molecular reaction of bevacizumab treatment, clarify the mechanism of drug resistance of bevacizumab treatment.

patient: adult glioma, pathological diagnosis combined with molecular diagnosis (i.e. idh- mutant glioma, idh- mutant glioma with 1p/19q- co-deletion, glioblastoma). the patients were divided into three groups: group a (idh mutant glioma), group b (idh mutant with 1p/19q co-deletion oligodendroglioma ) and group c (idh wild glioblastoma). from the first day after surgery, the ctdna was extracted with tisf before concurrent chemoradiotherapy as the baseline, and the ctdna was detected again after concurrent chemoradiotherapy. for the third time, ctdna was detected in temozolomide intensive chemotherapy. ctdna was detected for the fourth time when the image showed tumor progression. after the progress, temozolomide combined with bevacizumab was used for chemotherapy. ctdna was detected 6 weeks after the application of bevacizumab, and ctdna was re-measured every 6 weeks during the treatment of bevacizumab. at the same time, imaging examination was performed to determine the tumor progress. check and record adverse events and drug use in detail, and evaluate the compliance of subjects; after tisf tissue extraction, the retained blood samples were sent to simcere company and beijing genetron health technology co. ltd for ctdna quantification and detection. to study the differences of gene evolution of different subtypes of glioma under pressure therapy, to clarify the differences of molecular responses of different subtypes of glioma to bevacizumab, and to evaluate the therapeutic effect and safety.

Eligibility criteria:
inclusion criteria: * age 18 to 75 years, both male and female (including 18 and 75 years old) glioma; * willing to accept treatment and sign informed consent. exclusion criteria: * participants with other infection disease or immunodeficiency disease; * other central infectious diseases; * malignant tumor of non-nervous system; * drug abuse; * severe psychiatric disease; * uncontrolled diabetes;

Keywords: gene evolution, ctdna, molecular response, bevacizumab
pharmacokinetics of acetaminophen in pediatric patients with congenital heart disease

Conditions: Congenital Heart Disease

Summary: this is a prospective study of pediatric patients with congenital heart disease, in which acetaminophen serum concentrations will be measured following a single intraoperative intravenous dose of acetaminophen. these levels will be used to develop a pharmacokinetic model. serum concentrations will be compared between two groups of patients: (1) cyanotic patients presenting for the fontan completion operation and (2) patients with acyanotic congenital heart disease presenting for repair via median sternotomy.


Eligibility criteria:
inclusion criteria: * patients presenting for fontan palliation or for surgical repair requiring median sternotomy, will be included in the study. * only patients who receive intravenous acetaminophen in the operating room will have serum levels drawn. exclusion criteria: * documentation of an allergy to acetaminophen * severe hepatic disease or other contraindications to acetaminophen use * patient has received acetaminophen within 24 hours of their procedure
safety and efficacy of autologous bone marrow stem cells for treating osteoarthritis

Conditions: Osteoarthritis

Summary: osteoarthritis is a leading cause of chronic disability in elderly and the risk of disability attributed to osteoarthritis is as great as or greater than due to any other medical condition in that age group. several cross sectional studies have demonstrated an age related increase in the prevalence of osteoarthritis of knee(5). results of survey are similar with most surgeons reporting 50+ years age group being commonest at initial presentation and that the incidence increases with advancing age. interestingly some surgeons have noticed earlier occurrence of osteoarthritis in 40+ years age group and one has to be careful to screen for secondary causes in this younger age group patients. while pain relief is the primary treatment goal of osteoarthritis medications, localized inflammation may also be relieved by using certain drugs. managing osteoarthritis pain can involve medications, natural remedies, exercise, weight loss, joint protection, mobility aids, assisted devices and more. stem cell therapy, using cells extracted from the same patient or suitable alternative human sources, targets diseases which are either incurable or with no complete or effective treatment available in the traditional healthcare system. since this therapy is based on the concept of regenerating damaged cells in the injured or disease-affected areas of the body, it is called regenerative medicine autologous stem cells provide an attractive option for osteoarthritis patients and their clinicians. in our present study we want to evaluate the safety and efficacy of autologous bone marrow derived stem cells in treatment of osteoarthritis for therapeutic chondrogenesis through delivery of stem cells into the knee joint space in ten indian patients.


Eligibility criteria:
inclusion criteria: 1. must be able to give voluntary written (patients may not be able to write) consent. 2. must be able to understand study information provided to him. 3. age 30 to 70, inclusive 4. oa kellgren and lawrence classification 3 \& 4 5. no ligamentous laxity i.e. stable 6. ability to understand and willingness to sign consent form 7. the participant is able to comply with and understand the required visit schedule and all required tests and procedures. exclusion criteria: 1. serious pre-existing medical conditions like diabetes mellitus, chronic renal failure, rheumatoid arthritis, collagen vascular diseases and autoimmune diseases 2. pregnant or lactating woman 3. inflammatory arthritis 4. oral steroid, methotrexate (immune suppressants) 5. history of drug or alcohol abuse or chronic smoking 6. poor patient compliance 7. infectious disease test positive for hiv 1\&2, hbsag, hcv and vdrl.

Keywords: osteoarthritis stem cell implantation bone marrow autologous