Kornimate/medical-research-clean huggingface dataset:
trial of e10a in head and neck cancer

Conditions: Head and Neck Squamous Carcinoma; Nasopharyngeal Carcinoma

Summary: angiogenesis, the formation of new blood vessel from existing vessels, is essential for tumor growth and metastasis. antiangiogenic therapies inhibit the growth of genetically stable endothelial cells, and most tumors should starve to death with little acquired resistance. endostatin has been shown to block endothelial cell proliferation, survival, and migration. antitumor activity of endostatin protein has been demonstrated in various murine and human tumors in animal model studies without any detectable toxicity. endostatin gene therapy could directly express the highly bioactive protein in vivo by means of the mechanism of eukaryotic expression system as post-translational modification and folding, as well as overcoming the challenge of the long-term storage and the cumbersome daily administration of endostatin protein. e10a is a replication-deficient recombinant adenovirus containing a wild-type human endostatin transgene constructed from serotype 5 adenovirus (ad5). preclinical studies demonstrated that intratumoral injection of e10a provided significant tumor growth inhibition and sustained elevation of endostatin in blood and tumor tissue in hepatocellular carcinoma, nasopharyngeal carcinoma, and tongue cancer animal models. a phase i clinical trial of e10a we conducted showed that repetitive intratumoral injection of e10a resulted in a small and sustained elevation of endostatin in blood and had a mild antitumor activities with very limited toxicity. the major toxicity was transient and manageable fever. a randomized phase iii trial in nonsmall-cell lung cancer showed endostatin improved response rate and time to tumor progression in combination to chemotherapy. therefore, we designed a randomized phase ii trial to explore the safety and effectiveness of e10a combined with chemotherapy in the treatment of patients with head and neck cancer.


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed recurrent or metastatic head and neck squamous carcinoma or nasopharyngeal carcinoma * the tumor was amenable to direct injection and measurement ( \> 2 cm) * an eastern cooperative oncology group (ecog) performance status of 0 to 2 * a life expectancy over three months * the absence of serious medical or psychiatric disorders * serum creatinine \ 3,000/mm3, platelet count \> 80,000/mm3, hemoglobin \> 8 g/dl; total bilirubin value \< 1.5 times the upper limit of normal \[uln\], alt level \< 2.5 times uln, ast \< 2.5 times uln. exclusion criteria: * pregnant or breast feeding * a history of brain metastases or a primary brain tumor * a history of hemorrhagic diathesis * a history of corticosteroids or immunosuppressives use within four weeks of study entry * a history of immune deficiency disorder or organ transplant * has evidence of active adenovirus infection or uncontrolled infection * received any chemotherapy or radiotherapy within four weeks of study entry

Keywords: clinical trial randomized endostatin gene therapy head and neck cancer head and neck squamous carcinoma
comparative prospective data collection in connection with two different treatment methods: robotic assisted laparoscopy and conventional laparoscopy

Conditions: Uterine Diseases

Summary: this is a prospective, randomized, single-center, observational clinical trial at the department of women's health of the university clinic tübingen. four hundred patients affected by uterine diseases that undergo treatment with robotic assisted laparoscopic procedures using the da vinci robotic surgical system (200 patients) or conventional laparoscopic surgery (200 patients) will be recruited. in addition retrospective data of 200 patients that underwent conventional laparoscopic surgery in the past will be documented. at the end of patient recruitment, surgical procedure times, the technical limits encountered, estimated blood loss, intra- and post-operative complications and the percentage of conversions from the robotic assisted treatment /conventional laparoscopic surgery to multiple access and/or to a laparotomic (open) approach will be documented.


Eligibility criteria:
inclusion criteria: * age ≥18 years * bmi ≤40 kg/m2 * indication for hysterectomy for benign disease or prophylactic surgery due to hereditary cancer * indication for radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for cervical cancer * indication for modified radical hysterectomy and/or pelvic-/para-aortic (sentinel-node) lymphadenectomy for endometrial cancer * size of uterus and vagina allows for retrieval by the vaginal route in cancer patients * written informed consent exclusion criteria: * known extensive intra-abdominal adhesions * anaesthesiological contraindications to laparoscopy * women with pacemaker or other implants where electrosurgery is to be avoided * women with known defects of the hemostasis * pregnancy * other internal or anatomical criteria that preclude a minimal invasive approach * inability to understand patient information
the brain changes in sleep apnea study

Conditions: Sleep; Sleep Apnea; Sleep Apnea Syndromes

Summary: sleep is critical to human health, but insufficient and disrupted sleep caused by sleep apnea are common and have a major impact on brain health. however, there is still much that is not known about how sleep apnea damages the brain and what can be done to fix this. the brain changes in sleep apnea study will look at the brain health of people with severe sleep apnea both before and after 4 months of treatment with a cpap machine. pre- and post-cpap treatment, 80 participants with severe sleep apnea will undergo cognitive testing, blood and urine tests, a pulse wave velocity test, and an mri. also pre- and post-cpap treatment, participants will wear a blood pressure monitor for 24 hours, wear an accelerometer watch for 8 nights to track the duration and quality of their sleep, and wear a device for 1 night of sleep to assess their breathing and blood oxygen levels. it is expected that there will be improvements in participants' brain health after 4 months of cpap treatment.

between january 2018 and february 2022, the brain changes in sleep apnea study will recruit 80 adults with newly diagnosed severe sleep apnea attending the sleep clinics at sunnybrook health sciences centre (n=40) or the university of edinburgh (n=40). participants will undergo home-based assessment with 3 wearable devices (24 hours of ambulatory blood pressure monitoring, 8 nights of actigraphy to assess sleep duration and fragmentation, and 1 night of finger-probe peripheral arterial tonometry and oximetry to assess cardiorespiratory physiology including sleep apnea), completion of a sleep and health questionnaire, 24-hour collection of urine for assessing sympathetic nervous system activity, blood banking for endothelial biomarkers, cognitive evaluation, pulse wave velocity test, and an mri of the brain, at 2 time points: 1) after initial polysomnographic diagnosis of sleep apnea but before the initiation of cpap, and 2) after 4 months of cpap treatment.

Eligibility criteria:
inclusion criteria: * newly diagnosed sleep apnea not on cpap or any other treatment for sleep apnea; * apnea hypopnea index \>=15 on diagnostic polysomnogram; * oxygen desaturation index \>=10 or o2 saturation in sleep \ 15 minutes on diagnostic polysomnogram; * subjectively sleepy; * planning on starting cpap for sleep apnea. exclusion criteria: * known history of stroke, transient ischemic attack, or other cns disease; * unable to safely undergo mri; * use of alpha-blocking agents; * persistent non-sinus arrhythmia; * severe pulmonary or cardiac diseases including copd and chf; * waking spo2\<90%; * history of panic disorder.
imu-935 in patients with progressive, metastatic castration resistant prostate cancer

Conditions: Metastatic Castration Resistant Prostate Cancer

Summary: dose escalation study to evaluate the safety, tolerability and anti-tumor activity of single agent imu-935 in patients with progressive, metastatic castration resistant prostate cancer (mcrpc).

this is an open-label, non-randomized phase 1 dose escalation, followed by dose expansion, study to define the safety, tolerability, biomarker change and anti-tumor activity of imu-935 in patients with mcrpc. throughout the study, safety, anti-tumor activity, biomarkers and imu-935 plasma concentrations will be evaluated at regular intervals as per schedule of assessments. disease progression will be assessed as per standard medical practice. the dose escalation and expansion parts of the study will have the same treatment duration with similarly structured treatment cycles. the study will consist of the following periods: * screening period: approximately 28 days * treatment phase: main treatment over 3 cycles of 28 days each, extended treatment as long as patient benefits

Eligibility criteria:
inclusion criteria: * age ≥18 years * male patients with histologically or cytologically confirmed adenocarcinoma of the prostate with no evidence of small cell or neuroendocrine features * metastatic disease with limited therapeutic options, prior treatment with at least one next-generation hormonal agent (e.g., abiraterone, enzalutamide, apalutamide, darolutamide) and one taxane line of treatment is allowed * progressive disease is defined as rising prostate-specific antigen (psa) levels ≥2ng/ml and/or radiographic progression according to prostate cancer working group 3 (pcwg3) criteria at screening * able and willing to comply with all study requirements for the duration of the study * patients must sign an icf prior to the start of any study-related procedures exclusion criteria: * anti-tumor therapy (chemotherapy, antibody therapy, molecular targeted therapy) within 28 days prior to starting study treatment * uncontrolled intercurrent illness such as active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hypertension, or psychiatric illness/social situations that would limit compliance with the study protocol * malignancy within the previous 2 years with a ≥30% probability of recurrence within 12 months, with the exception of non-melanoma skin cancer or superficial bladder cancer * patients receiving strong inhibitors or inducers of cytochrome p450 (cyp) 3a4 * chronic use of systemic steroid therapy (\>1 month of \>10 mg prednisone per day or equivalent, except replacement therapy) * patients for whom biopsies cannot be taken or are not willing to undergo biopsies * positive hepatitis b virus (hbv) surface antigen, hepatitis b core antibody, positive hepatitis c virus (hcv) antibody, and/or hiv-antigen-antibody test at screening
evaluation of efficacy of lycium barbarum polysaccharide in people with subthreshold depression

Conditions: Subthreshold Depression; Depressive Symptoms; Anxious Symptoms

Summary: lycium barbarum, a traditional chinese herbal medicine, is a commonly used herb in the traditional chinese pharmacopoeia . its main active ingredient, lycium barbarum polysaccharide (lbp), is reported to have neuroprotective effects. animal studies suggested that lbp has neuroprotective effect on optic ganglion cells. in animal models of depression, lbp can improve depressive symptom by improving synaptic plasticity. however, its clinical effect remains to be studied. we will conduct a 6-week double-blind, randomized, placebo-con-trolled trial in people with subthreshold depression.the purpose of this clinical trial is to investigate the efficacy of lbp in people with subthreshold depression.


Eligibility criteria:
inclusion criteria: 1. 15-25 scores in the beck depression rating scale (bdi- ii) 2. there is no contraindication of taking lbp. exclusion criteria: 1. current treatment for a mental health problem from a mental health professional 2. current and lifetime history of psychiatric disorders (e.g major depressive disorder, as ascertained by cidi 3. systemic disease requiring regular medication. 4. there are suicidal ideation, suicidal attempt, suicide behavior and attempted suicide. 5. dislike of or allergy to goji berry 6. hormone or endocrine therapeutic drugs are being taken. 7. long-term use of lycium chinensis in recent three months

Keywords: major depressive disorder lycium barbarum polysaccharide depressive symptoms anxious symptoms
the diagnosis and treatment pattern of ckd in patients with cardiovascular disease- a national cross-sectional study

Conditions: Renal Insufficiency, Chronic; Cardiovascular Diseases; Diagnosis

Summary: the goal of this observational study is to learn about in a total of approximately 2000 patients with cardiovascular disease recruited from about 25 participating sites in china with egfr\ 30 mg/g at least twice 3 months apart within the previous 12 months who had been hospitalized in the cardiology department within the previous 12 months. the main questions it aims to answer are: * to estimate the diagnosis rate of ckd in patients with cardiovascular disease and laboratory evidence of ckd * to describe the ckd awareness and treatment pattern in patients with cardiovascular disease and laboratory evidence of ckd. * to describe the socio-demographic and clinical characteristics of ckd in patients with cardiovascular disease and laboratory evidence of ckd participants will be invited to undergo a baseline visit, and the demographics, lifestyle factors, clinical characteristics, and laboratory tests will be collected.


Eligibility criteria:
inclusion criteria: 1. female and/or male aged ≥18 years 2. admitted to the cardiology department with diagnosed cardiovascular disease within the previous 12 months 3. participants with egfr\ 30 mg/g at least twice 3 months apart within the previous 12 months exclusion criteria: 1. participants with known egfr\<20 ml/min/1.73 m2 or undergoing dialysis or kidney transplantation 2. pregnant or lactating women 3. exposure to contrast medium or other reason leading to potential acute kidney injury since the baseline examination of egfr/uacr 4. patients who were participating in or had participated in any other clinical trial within the previous 12 months
effect of paricalcitol over vessel wall

Conditions: Nephropathy

Summary: to provide evidence based prospectives of the potential benefit effects of paricalcitol, an analog of vitamin d, over the prevention / retardation of the progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.

providing prospective results based on evidence of potential beneficial effects of paricalcitol, an analogue of vitamin d in the prevention / delay of progression of neoangiogenesis (vessels), atherosclerosis and vascular calcification.

Eligibility criteria:
inclusion criteria: * patients aged between 50 and 75 years. * chronic kidney disease stage 5 d or 4-5 no d as calculated glomerular filtration rate (mdrd). * concentration of intact parathyroid hormone (ipth): 150-400 pg/ml. * plasma concentrations of 25 (oh) vitamin d \<30 ng/ml. * without vitamin d supplementation for 3 months before the study. * serum p\> 3.8 mg / dl. * serum ca\> 9.8 mg / dl. * no history of cardiovascular events (angina or myocardial infarction, stroke, peripheral arterial disease). * no exclusion criteria for the use of contrast. exclusion criteria: * allergic reaction to sulfur hexafluoride. * recent unstable cardiac symptoms. * patients with recent coronary intervention (\<7 days) * patients with class iii and iv heart failure or severe arrhythmias. * severe pulmonary hypertension.
explore association models between environmental hormones andbreast cancer

Conditions: Breast Diseases; Breast Adenocarcinoma

Summary: investigated the association model between environmental hormone-related living habits and breast cancer, as well as dietary improvement programs through machine learning and clinical validation of patients with breast cancer.

female breast cancer is the second most common cancer worldwide and the age at diagnosis is decreasing. traditional risk factor screening for breast cancer focuses on reproductive history, family history, age at menarche, and age at menopause; however, young patients diagnosed with breast cancer who do not meet the above risk factors are becoming common.this study established an association model between environmental hormones and breast cancer through machine learning to improve dietary programs to reduce the incidence of breast cancer.

Eligibility criteria:
inclusion criteria: * (1) patients aged 20 years or above; (2) patients with breast cancer. exclusion criteria: * non-patients with breast cancer

Keywords: machine learning; association model; environmental hormones; breast cancer
can a rapid 2 day followup after discharge from the ed reduce readmissions and death for patients 75 years and older?

Conditions: Emergencies

Summary: our hypothesis is that a rapid follow up for elderly patients in a geriatric clinic discharged from the emergency department (ed) will have fewer unplanned return ed visits and fewer unplanned hospital admissions with no attendant increase in mortality. patients 75 years of age and older will be randomized following discharge from the ed into two groups. the first will receive standard post ed care. the second will receive an appointment to our geriatric clinic within 2-3 days for stabilization, further treatment and contact with the patient's primary physician to communicate the course of the patient's illness and to schedule subsequent follow-up with the patients regular medical provider. there will be two primary outcomes: the first will be a composite of morality and/or return to the ed at 30 days, and the secondary primary outcome will be mortality. economic data regarding resource utilization by patients will also be analyzed.


Eligibility criteria:
inclusion criteria: * all patients 75 years of age and older discharged from the ed exclusion criteria: * younger than 75.

Keywords: emergency department, geriatrics, mortality, readmission rates. patients 75 years of age and older.
tirofiban for the prevention of neurological deterioration in acute ischemic stroke

Conditions: Acute Stroke

Summary: currently, dual antiplatelet therapy with aspirin and clopidogrel (with loading doses) is widely used for patients with acute ischemic stroke. however, immediate, potent and reversible inhibition of platelet aggregation is not possible. additionally, more than 5% patients have aspirin resistance and more than 15% patients have clopidogrel resistance. therefore, an intravenously administered gpiib/iiia receptor inhibitor (tirofiban) receptor blocker with fast onset and offset of actions will provide more desired antiplatelet effects in the setting of acute ischemic stroke, especially in patients with high risk of neurological deterioration. this study will measure the anti-platelet effects of tirofiban in patients with acute ischemic stroke who had high risk of neurological deterioration.


Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke with 24 hours of symptom onset. 2. nihss≥4 and ≤20 points, and the paralyzed limbs is able to actively move the muscle (standardized motor examination rating scale of 2 or much higher). 3. age 18-80 years old. 4. informed consent obtained from patient or acceptable patient's surrogate. exclusion criteria: 1. treated with intravenous or endovascular thrombectomy for the indexed acute ischemic stroke. 2. acute ischemic stroke caused by determined or suspected cardioembolism. 3. acute ischemic stroke caused by other determined caused, including moyamoya disease, artery dissection, arteritis, and etc. 4. pre-stroke mrs ≥2 or the paralyzed limbs are dyskinesia before stroke. 5. known hematochezia, gastrointestinal bleeding and any other bleeding. 6. allergy to tirofiban or its solvents. 7. patients suffered from severe diseases, including malignant tumor, liver cirrhosis, kidney failure, congestive heart failure, and etc. 8. gastrointestinal or genitourinary tract bleeding within 1 years. 9. determined coagulation disorders, platelet dysfunction, or platelet count \<100\*109/l. 10. major surgical operation or severe trauma within 1 month. 11. hemorrhagic retinopathy. 12. chronic hemodialysis. 13. uncontrolled hypertension with systolic blood pressure \>180 mmhg or diastolic blood pressure \>110 mmhg. 14. acute pericarditis. 15. other conditions that determined by the investigators.

Keywords: acute ischemic stroke neurological deterioration stroke progression
audit of bronchoscopy practice in egypt: adherence to safety and infection control guidelines

Conditions: Infection Control

Summary: both patient and staff safety are of major importance during the procedure of fibreoptic bronchoscopy. patient safety depends partly on adequate disinfection of instruments and accessories used as well as careful monitoring during the procedure.

adequate facilities, manpower and training are also essential. staff safety depends partly on adequate procedures to minimise any risks of sensitisation to agents such as glutaraldehyde. an audit well be carried out of bronchoscopy procedures in hospitals in the egypt and the findings well be compared with published guidelines on good practice and clinical consensus

Eligibility criteria:
inclusion criteria: * bronchoscopy units personnel exclusion criteria: * n/a

Keywords: audit infection control bronchoscopy unit egypt
is copd a risk factor for cardiovascular disease?

Conditions: Chronic Obstructive Pulmonary Disease

Summary: patients with chronic obstructive pulmonary disease suffer from significant cardiovascular morbidity and mortality. this study wants to determine whether chronic obstructive pulmonary disease might be a risk factor for coronary atherosclerosis and other cardiac markers independent of conventional cardiovascular risk factors. the study is designed as a retrospective matched case-control study with follow-up via telephone interview.

patients with chronic obstructive pulmonary disease (copd) suffer from significant cardiovascular morbidity and mortality. coronary artery disease has often been linked causally to copd, but the exact pathophysiological mechanisms underpinning this association remain speculative. a retrospective case-control study matching copd patients and controls one to one for smoking history and conventional cardiovascular risk factors will be performed to study the association between copd and cardiovascular outcomes. filling in this knowledge gap may contribute to the understanding of the interplay between copd and cardiovascular disease. the objective of this retrospective case-control study is to determine whether copd might be a risk factor for coronary atherosclerosis, impaired left ventricular ejection fraction, and major adverse cardiovascular events independent of conventional cardiovascular risk factors.

Eligibility criteria:
inclusion criteria: * spect-ct imaging due to preoperative assessment between 01.01.2007 and 31.07.2013. * coronary artery calcium score and left ventricular ejection fraction data available. * history of smoking (smoker or ex-smoker). * copd group: documented chronic obstructive pulmonary disease (post-bronchodilator fev1/fvc \< 0.7). * control group: exclusion of chronic obstructive pulmonary disease (post-bronchodilator fev1/fvc \> 0.7). exclusion criteria: * known coronary artery disease or coronary symptoms (angina pectoris) at the time of the spect-ct investigation. * known congenital or structural heart disease. * previous heart transplantation.

Keywords: chronic obstructive pulmonary disease coronary artery disease coronary calcium score