Kornimate/medical-research-clean huggingface dataset:
prostate cancer circulating tumor cells based on epithelial-mesenchymal transition biology

Conditions: Prostate Cancer

Summary: this is a minimal risk correlative clinical blood-drawing protocol. the objective of this lead in pilot component is to determine whether circulating tumor cells (ctc's) can be captured using the novel mesenchymal-marker based near infrared-emissive polymersomes (nir-eps), the psma-based nir-ep, and the epithelial epcam-based nir-ep. if successful, the capture method will be evaluated further in the larger comparative study.


Eligibility criteria:
inclusion criteria: * histologically confirmed diagnosis of adenocarcinoma of the prostate * clinical or radiographic evidence of metastatic disease * evidence of disease progression on androgen deprivation therapy (adt) as evidenced by either of the following in the past: 1. two consecutive psa levels greater than the psa nadir achieved on adt, separated by greater than one week 2. radiographic evidence of disease progression as defined by new bone scan lesions or soft tissue/visceral metastases \>2 cm in diameter. 3. clinical progression as determined by the treating physician. * age greater than 18 years. * ability to understand and the willingness to sign a written informed consent document exclusion criteria: * history of intercurrent or past medical or psychiatric illness that would make participation in a blood drawing protocol difficult or not feasible at the discretion of the principal investigator or co-investigator(s)

Keywords: prostate cancer metastatic castrate resistant
understanding decentralized trial engagement and clinical impediments through digital efforts (udecide) among unrepresented groups with poor cardiovascular and cardiometabolic health

Conditions: Heart Diseases

Summary: the objective of the udecide study is to demonstrate adherence to decentralized clinical trials among underrepresented groups with cardiometabolic conditions .


Eligibility criteria:
inclusion criteria: * history of pre-diabetes/diabetes and/or pre-hypertension/hypertension * history of cardiometabolic risk factors including the following: hypertension, coronary artery disease (cad), heart attack, heart failure, stroke, atherosclerosis, arrhythmias, peripheral artery disease (pad), type 2 diabetes, metabolic syndrome, obesity, dyslipidemia, insulin resistance, or elevated cholesterol. * identify as black or non-white hispanic * own a smart phone exclusion criteria: * does not meet inclusion criteria
neoadjuvant chemotherapy for patients with advanced gastric cancer in eras programs for radical gastrectomy

Conditions: Gastric Cancer

Summary: patients with advanced gastric cancer received neoadjuvant chemotherapy undergo enhanced recovery after surgery (eras) programs.

in recent years, enhanced recovery after surgery (eras) programs were applied in gastrectomy in areas with a high prevalence of gastric cancer, such as china and japan, confirming that eras programs accelerate the postoperative rehabilitation of gastric cancer patients without increasing the occurrence rate of postoperative complications. however, in most studies on eras for gastric cancer, patients who received neoadjuvant chemotherapy were excluded. investigators designed this study aimed to evaluate whether patients who receive neoadjuvant chemotherapy can enrolled into enhanced recovery after surgery programs for locally advanced gastric cancer.

Eligibility criteria:
inclusion criteria: 1. patients with locally advanced gastric cancer. 2. age older than 18 and younger than 75 years. 3. american society of anesthesiologists (asa) class: i-iii. 4. participants can describe the symptom objectively and cooperate actively. 5. written informed consent exclusion criteria: 1. patients allergic to oxaliplatin, tegafur gimerac etc. 2. patients with ischemic heart disease, cerebrovascular disease and peripheral vascular disease, or cardiac function \> ii (nyha) 3. patients with complications (bleeding, perforation and obstruction) caused by gastric cancer. 4. patients with severe liver and renal dysfunction (child - pugh ≥ 10; cr \< 25 ml/min). 5. patients who require simultaneous surgery for other diseases. 6. patients who received upper abdominal surgery previously. 7. pregnant or breast-feeding women.

Keywords: gastric cancer neoadjuvant chemotherapy enhanced recovery after surgery gastrectomy
effect of pilates core stabilization in adjunct with plyometric shoulder training on low back pain in fast bowlers(rct)

Conditions: Low Back Pain

Summary: this rct will seek to determine both the pilates core stabilization and plyometric shoulder training on lbp in fast bowlers. the research problem will emphasize the absence of detailed rehabilitation protocols that address the upper and lower limb strength dysfunction, pain, quality of life, and biomechanics of fast bowlers. prior literature has not examined the combined use of these two training interventions to address lbp, which affects the performance of fast bowlers. in this study, participants will be randomly assigned to two groups. group a (experimental) will receive pilates core stabilization and plyometric shoulder training, while group b (control) will receive conventional physiotherapy for lbp. there will be two sessions per week for six weeks, and the intensity of the exercises will gradually increase to address athletes' strength, flexibility, and movement control.

assessments will be conducted using multiple scales of upper limb strength for the cricket ball throw test, lower limb strength for the vertical jump test, quality of life for the oswestry disability index, biomechanics analysis to determine movement efficiency and pain intensity for numeric pain rating scale. this study will give information about the efficiency of adding core and shoulder training to managing lbp in fast bowlers, increasing their athletic performance and bringing helpful value to the sports and physiotherapy domain.

Eligibility criteria:
inclusion criteria: * age between 17-25 years * male cricket players * playing cricket for more than 2 years * low back pain without radiation * chronic low back pain for more than 3 months * non-specific mechanical type without identifiable specific anatomical or neurophysiological causative factors and medically fit exclusion criteria: * any pathological condition of the spine, hip, knee, and pelvis. * any history of musculoskeletal injury in the past 6 months. * any history of a neurological condition. * uncontrolled metabolic disorders such as diabetes mellitus * any surgical h/o shoulder or elbow in the past 6 months
systematic symptom identification with disease specific prom to assess symptoms of chronic gvhd in outpatient care in patients post hsct

Conditions: GVHD, Chronic; Hematological Malignancy

Summary: a two sited feasibility study to test the feasibility of systematic symptom identification with disease specific and clinically developed prom (lee symptom scale) longitudinally with a 12 month follow up in outpatient care in patients post hsct to assess symptoms of chronic gvhd (n= 30).

a prospective, non-randomized, feasibility study examining a systematic approach to symptom management using proms with 12 months of follow up in hematological outpatient clinic

Eligibility criteria:
inclusion criteria: * adults \> 18 years old * approximately 3 months post hsct (they will be included before hsct, but the intervention will begin at 3 moths). * patients included needs to be able to manage a computer to receive and respond to collect pro data. exclusion criteria: * patients who do not understand, read and speak danish and/or have cognitive/psychiatric disorders not compatible with inclusion in a clinical study.

Keywords: lee symptom scale symptom management patient reported outcome
clinical utility of vi-rads in diagnosis of mibc

Conditions: Radical Cystectomy; Muscle-Invasive Bladder Carcinoma; Multiparametric MRI; Vesical Imaging Report and Data System

Summary: bladder cancer (bca) is the 9th most common cancer worldwide. in general, bca is presented as a non-muscle invasive bladder cancer (nmibc) in 70% of patients and treated with transurethral resection of bladder tumor (tur-bt). however, in cases of muscle invasive bladder cancer (mibc), radical cystectomy (rc) is the gold standard of treatment. therefore, it is important to distinguish mibc from nmibc. to date, pathologic staging is based on the result of tur-bt before rc. however, it is operator dependent, thus residual cancer may be remained depending on surgical experience. therefore, about 7%-30% patients of mibc can be underestimated with nmibc, and it can be increased to 45% if the muscle is not resected. consequently, it has been raised the need for imaging test to overcome diagnostic limitations. multiparametric magnetic resonance imaging (mpmri) has been widely used in the field of diagnosis of bca. in 2018, the vesical imaging report and data system (vi-rads) was published using t2-weighted imaging (t2wi), diffusion-weighted imaging (dwi), and dynamic contrast enhanced (dce) imaging, and 5-point vi-rads scoring system has been proposed and reported as an imaging test useful for assessing muscle involvement in primary bladder cancer therefore, in this study, we investigate the diagnostic performance of the vi-rads scoring system that can differentiate nmibc from mibc in primary bladder cancer.


Eligibility criteria:
inclusion criteria: * older than 18 years * primary bladder cancer in cystoscopy * suitable for mri and tur-bt * agreement to participate in the study and signing of an informed consent form exclusion criteria: * history of tur-bt * previous radiation and/or chemotherapy for bladder cancer * not suitable for mri or tur-bt
lpn in patients with high-complex renal tumors

Conditions: Renal Cancer; Renal Neoplasm; Renal Cell Carcinoma; Surgery; Oncology; Kidney Ischemia; Kidney Injury; Urologic Neoplasms; Urologic Cancer; Kidney Neoplasms

Summary: the study aims to investigate the rationale for lpn in patients with high-complexity renal tumors in terms of oncologic and functional outcomes.

from november 2009 to october 2018, 399 patients underwent lpn and 307 patients to laparoscopic radical nephrectomy (lrn). 41 patients with renal score ≥ 10 enrolled in lpn and 265 patients to the lrn group. propensity score matching (matched by age, gender, clinical tumor stage, tumor size, baseline renal function, comorbidities such as diabetes mellitus (dm), hypertension (ht), coronary artery disease (cad), and final tumor pathology of rcc) was used to reduce selection bias. functional and oncological outcomes were compared between the two groups. after propensity score analysis, 39 patients in the lrn group were matched with 39 in the lpn group.

Eligibility criteria:
inclusion criteria: * patients with complete data * patients with single renal tumor on the effected side * patients who approved the written consent form exclusion criteria: * patients who not approved the written consent form * patients with incomplete data * patients with low or mild complexity renal tumors

Keywords: laparoscopy nephrometry score partial nephrectomy propensity score matching radical nephrectomy
effects of head-of-bed on intracranial pressure

Conditions: Subarachnoid Hemorrhage, Aneurysmal

Summary: the purpose of this study is to evaluate how pressure inside the skull responds to position changes in patients with brain bleeds.

the optimal positioning of the head-of-bed (hob) has remained controversial in the neurosurgical field. very limited data exists outlining the effects of hob positioning in subarachnoid hemorrhage (sah) patients. one study by schulz-stubner and thiex assess the effects of hob positioning in sah and traumatic brain injury (tbi) patients. while this study offers some valuable insight into the changes in cerebral hemodynamics seen when the hob changes, it congregates data from two very different pathologies. this could potentially misrepresent the true effects patients experience. a study by kung et al. assesses cerebral blood flow dynamics and hob changes in the setting of sah but does not evaluate the effects on intracranial pressure (icp) (kung, et al., 2013). there appear to be no studies which evaluate the effect of hob positioning on icp in patients with sah. no current data exists to determine if dependent leg positioning would help to further lower icp. theoretically, placing a patient's legs in a dependent position would lead to increased venous pooling of blood in the legs which might translate to lower icp.

Eligibility criteria:
inclusion criteria: * patients with subarachnoid hemorrhage confirmed by ct scan, mri, or cerebral angiogram * age ≥ 18 years old * patients with intracranial pressure monitoring device * patients with continuous arterial blood pressure monitoring * the subject or legally authorized representative must be available and able to consent exclusion criteria: * intubated patients who are prone * patients with left ventricular ejection fraction \<20% as evidenced by echocardiogram previously documented at any time in the electronic medical record * patients with a diagnosis of pulmonary hypertension * patients with a diagnosis of cirrhosis and/or evidence of liver failure. evidence of liver failure will be assessed by the presence of ascites, edema, abnormal lab values including low albumin, elevated ptt, elevated pt, elevated inr, or elevated bilirubin without another etiology, or meld score \>8. * patients who are clinically unstable defined as those who are unable to lie flat for 30 minutes for any reason, patients on more than one continuous iv medications to increase blood pressure, or patients who are actively undergoing resuscitation.

Keywords: hemorrhage, subarachnoid intracranial pressure
the effect of motivational messages on emergency nurses

Conditions: Satisfaction; Compassion Fatigue; Communication, Social

Summary: aim and objectives: the aim of this study is to examine the effect of motivational notifications applied to emergency nurses on job satisfaction, compassion fatigue and communication skills during the covid-19 pandemic. background: emergency room nurses working on the front lines during the covid-19 pandemic; many factors such as excessive workload, prolonged working hours, threat of infection, death of the patients they care for have caused them to experience physical, social and psychological problems. design: it is a randomized controlled, open-label study. methods: this study was carried out with a total of 60 nurses working in the emergency units of two training and research hospitals in istanbul. participants were divided into motivational group and control group. motivational notifications were sent via short message service (sms) to the mobile phones of the participants in the motivational group (n=30) for 21 days. no motivational notification was sent to the control group (n=30) during this process. data were obtained with the individual introduction form, job satisfaction, compassion fatigue and communication skills scale.


Eligibility criteria:
inclusion criteria:the nurses working in the emergency room, working only in the day shift on weekdays, using mobile phones and volunteering to participate in the study were included in the study. - exclusion criteria: exclusion criteria for the study included being on leave for any reason (maternity, annual, medical) during the study dates, not completely filling in the data collection forms, or withdrawing from the study. -
impact of conventional treatments and clinical variables on thyroid cancer

Conditions: Thyroid Cancer

Summary: dtc has a generally favorable prognosis. the possibility to discriminate between patients with aggressive tumors and those with a more indolent behavior may reduce the need for unnecessary treatments. aim of this observational study is to evaluate how anamnestic, clinical, and histopathological variables may influence the outcome of the enrolled patients, both regarding morbidity and mortality and in terms of therapeutic choices. the study aims to evaluate the prognostic impact of the therapeutic interventions in terms of efficacy and regarding the appearance of adverse events.


Eligibility criteria:
inclusion criteria: - thyroid cancer diagnosis exclusion criteria: * patients unable to sign informed consent
effect of rotablator on balloon resistant calcified coronary lesion

Conditions: Coronary Artery Disease

Summary: the optimal treatment of calcified coronary lesion remained to be elucidated. a prospective, randomized controlled trial was perform to explore the immediate effect and long-term outcome of rotational atherectomy in patients with balloon resistant coronary lesion.

the inclusion criteria included patients presenting drug-resistant angina pectoris who underwent balloon resistant angioplasty. the exclusion criteria included: 1. acute myocardial infarction within the 28 days; 2. intolerance to aspirin, clopidogrel, contrast media, or statins; 3. angiographic visible thrombus, or dissection; 4. left ventricular ejection fraction (lvef)\<35%; 5. any type of cancer 6. hemorrhagic stroke

Eligibility criteria:
inclusion criteria: * drug-resistant angina pectoris * balloon resistant and angiographic calcified coronary lesion exclusion criteria: * acute myocardial infarction within 28 days; * intolerance to aspirin, clopidogrel, contrast media, or statins; * angiographic visible thrombus, dissection; * lvef \<35%; * any type of cancer; * hemorrhagic stroke
the efficacy and safety of endostar combined with taxane-based regimens for her-2-negative mbc patients

Conditions: Angiogenesis; Breast Cancer

Summary: the purpose of the present study was to prospectively evaluate the efficacy and safety of endostar, a recombinant product of endostatin, combined with taxane-based regimens for her-2 negative metastatic breast cancer (mbc) patients.

endostar is a recombinant product of endostatin, which is an endogenous inhibitor of angiogenesis. animal studies have shown that endostatin is capable of blocking the proliferation and organization of endothelial cells into new blood vessels in vitro and inhibiting angiogenesis and growth of both primary tumors and secondary metastasis. regarding breast cancer, in vivo studies showed that the combination of paclitaxel and p125a-endostatin inhibited mammary cancer growth, delayed the onset of multifocal mammary adenocarcinomas, decreased tumor angiogenesis, increased the survival of treated mice in the prevention model, and inhibited lung and lymph node metastasis in the intervention model. moreover, in a prospective, randomized, controlled, phase ii neoadjuvant trial, the combination of rh-endostatin with chemotherapy produced a higher tumor response rate without increasing toxicity in breast cancer patients. considering these promising data, this prospective study was conducted to evaluate the efficacy and safety of endostar combined with taxane-based regimens for her-2-negative mbc patients.

Eligibility criteria:
inclusion criteria: * women with ages between 18-70 years with histologically confirmed mbc documented as her-2-negative exclusion criteria: * cannot tolerated chemotherapy * cardiac insufficiency

Keywords: metastatic breast cancer her-2-negative endostar
a trial of hrs-9813 capsule and tablet in healthy subjects

Conditions: Pulmonary Fibrosis

Summary: this is a phase ⅰ study to evaluate the relative bioavailability of hrs-9813 capsule and tablet in healthy subjects and the effect of food on the pharmacokinetics of hrs-9813 capsule.


Eligibility criteria:
inclusion criteria: 1. aged 18-45 years. 2. male weight ≥ 50 kg, female weight ≥ 45 kg, and body mass index (bmi): 19-26 kg/m2. 3. subjects not with clinically significant vital signs and laboratory tests. 4. take contraception measures. exclusion criteria: 1. any serious clinical diseases that affect the absorption, metabolism and/or excretion of the study drug. 2. severe infection, severe trauma or major surgery. 3. any medications in the two weeks before screening or baseline period. 4. history of blood donation or severe blood loss. 5. have been vaccinated within 2 weeks before the screening or baseline period. 6. history of smoking or excessive alcohol or drug abuse. 7. other situations that the researcher judges to be unsuitable.
connect to protect (c2p): building a community-based infrastructure for hiv prevention

Conditions: HIV Infection

Summary: the proposed study seeks to continue the implementation of connect to protect® (c2p), a community mobilization intervention, which entails developing coalitions to plan for and bring about structural changes for purposes of reducing hiv incidence and prevalence among youth in targeted communities at five atn sites.

the c2p community mobilization model entails: determining a geographic area and population of focus for the coalitions to prioritize their planning and action; developing coalitions that have a shared vision and mission; developing a strategic plan focused on structural changes to reduce risks associated with hiv; documenting processes; providing feedback as technical assistance to the coalitions; hosting regular working group meetings; and on-going capacity building. the national coordinating center (ncc), operating under the direction of the protocol chair, provides guidance, training, technical assistance and feedback to coalitions. the evaluation of c2p includes both process evaluation (i.e., documentation of coalition actions and achievements of structural changes; and outcome evaluation to qualitatively assess (via key informant (ki) interviews) if and how c2p efforts, including completed structural changes, have influenced the risk environment within each community. in addition, local health surveillance data and hiv testing data will be used to evaluate changes in hiv testing patterns and hiv/sexually transmitted infection (sti) morbidity among youth.

Eligibility criteria:
1. the intervention group = community members who become engaged in the coalitions and in the broader mobilization effort; and 2. the evaluation group = key informants within each c2p community who either work or reside within the sectors or systems where structural changes have been accomplished and/or the coalition has focused their strategic planning efforts.

Keywords: hiv prevention hiv positive communities
registry for stage 2 type 1 diabetes

Conditions: Type 1 Diabetes

Summary: stage 2 type 1 diabates (t1d) is an early stage of t1d characterized by dysglycemia but not yet leading to clinical symptoms. progression of the disease to stage 3 (clinical t1d), leads to overt hyperglycemia requiring eventually exogenous insulin. tzield® (teplizumab-mzwv) has been approved to delay onset of stage 3 t1d, by the united states (us) food and drug administration (fda) for adults and children aged 8 years and older with stage 2 t1d. the purpose of this study is to collect general information on patients with stage 2 t1d and further information on the long-term effects of tzield® in patients with stage 2 t1d, treated as per standard of care.


Eligibility criteria:
inclusion criteria: tzield-exposed cohort * patients in the us diagnosed with stage 2 t1d who are planned to initiate tzield treatment according to the currently approved label or who have initiated tzield treatment within 6 months prior to enrollment: * day 1: 65 mcg/m2 * day 2: 125 mcg/m2 * day 3: 250 mcg/m2 * day 4: 500 mcg/m2 * days 5 through 14: 1,030 mcg/m2 per day * cumulative dose is approximately 11,240 mcg/m2 * appropriate written informed consent/assent as applicable for the age of the patient tzield-unexposed cohort * patients in the us diagnosed with stage 2 t1d but who are not treated with tzield * appropriate written informed consent/assent as applicable for the age of the patient exclusion criteria: * patients who initiated tzield treatment more than 6 months prior to enrollment * patients who had participated in a previous clinical trial for tzield * patients in an ongoing clinical trial of an investigational product or who had ended participation within 6 months prior to study enrollment; patients participating in other observational studies may be enrolled