Kornimate/medical-research-clean huggingface dataset:
risk stratification of patients using the lung cancer biomarker panel in china

Conditions: Lung Neoplasms

Summary: the purpose of this study is to verify clinical utility of a simple blood test comprising of four protein- based markers for risk stratification of patients presenting symptoms related to lung cancer.

the study is a multicenter, prospective case-control research. totally 1,200 cases will be collected in the hospitals, with 600 cases in control group, which are not suspected as lung cancer from chest ct, and other 600 in suspected group. when inclusion into the two groups, clinical information and 10ml blood sample of the patient will be recorded and tested for cancer biomarkers, biochemical detection and cardiovascular disease biomarkers, etc. the correlation between cancer biomarker panel, ct scan result and clinical pathological diagnosis will be investigated through cases follow up. the sample size estimated above was set up according to sensitivity and specificity of biomarkers in pre-study, based on lung cancer incidence of the population. to compare the diagnostic accuracy among different cancer biomarkers through t-test, mann-whitney u and receiver operating characteristic (roc) curve with spss 15.0 software. in statistic analysis, 0.05 is set as the p value for significance. effectiveness of the four biomarkers panel in lung cancer diagnoses and staging will be analyzed.

Eligibility criteria:
inclusion criteria: * non-suspected lung cancer group (600 cases) 1. aged 40 to 75 years; 2. male smoker (≥400 cig/year), female smoker or non-smoker; 3. visible lung nodule lesion in the chest (based on local ct result); 4. without the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery. * suspected lung cancer group (600 cases) 1. aged 40 to 75 years; 2. male smoker (≥400 cig/year), female smoker or non-smoker; 3. visible lung cancer lesion in the chest (based on local ct result); 4. with the indication of biopsy (bronchoscope or percutaneous transthoracic) or surgery. exclusion criteria: * histopathological diagnosis result is unavailable, including patients only have cytology results of pleural effusion; * already treated by chemotherapy or surgery

Keywords: carcinoma, non-small-cell lung small cell lung carcinoma biological markers roc curve delayed diagnosis
the degen study: post-market clinical follow-up on the pass lp, pass degen and pass tulip systems (pass degen)

Conditions: Thoracolumbar Disc Degeneration; Thoracolumbar Spondylolisthesis; Spinal Deformity; Spinal Degeneration

Summary: the purpose of this post-market clinical study is to evaluate the long-term safety and efficacy of the medicrea's systems pass lp, pass degen, and pass tulip prime to treat degenerative diseases. this study is supporting the clinical evaluation report. from the standard-of-care perspective, the results of the degen study are expected to contribute to a better understanding of expected safety and clinical outcomes from a short (intra- and peri-operative) to a medium-term follow-up (post-operatively).


Eligibility criteria:
inclusion criteria: * patients of at least 18 years old * patient suffering from a spinal degenerative disease. * patient requiring spinal surgery for less than 4 levels for a spinal degenerative disease * patient implanted with medicrea's products, or patients who are candidate to receive including at least the pass lp and/or pass degen and/or pass tulip prime implants * patient affiliated to a national insurance system exclusion criteria: * patient unable or unwilling to sign and understand an information note with proof of patient consent * patient unable to complete a self-administered questionnaire * patient presenting contra-indications to a xray follow-up * patient of more than 18 years old under a protection procedure * patient judged as non-compliant by the investigator or not able to come back for follow-up visits up to 2 years
comparison of postoperative analgesic efficacy of intravenous dexketoprofen trometamol with tenoxicam

Conditions: Postoperative Pain

Summary: in this study the investigators aimed to compare of postoperative analgesic effects of intravenous dexketoprofen trometamol and tenoxicam in lumbar disc surgery.

lumbar disc surgery is associated with moderate to severe back and radicular pain postoperatively which has unfavorable effects on patients recovery and procedures outcome. dexketoprofen has been reported to be one of the nsai̇ds that can provide good results when compared with narcotics in many painful conditions and especially in the treatment of the moderate to severe postoperative pain that may develop after lumbal disc surgery. tenoxicam is a thienothiazine derivative of the oxicam class of nsai̇ds. there are some studies in which nsai̇ds have been used to together with opioids for postoperative analgesia showing that they decrease opioid consumption and side effects

Eligibility criteria:
inclusion criteria: * asa 1-2 * between 18-65 age * elective lumbar disc surgery exclusion criteria: * history of gastrointestinal bleeding * peptic ulcer disease * bleeding disorders * history of allergic reactions to nsai̇ds * chronic pain syndrome

Keywords: dexketoprofen trometamol tenoxicam postoperative pain
a comparison of ultrasound versus fluoroscopic guidance for sacral lateral branch blocks

Conditions: Back Pain

Summary: sacral lateral branch blocks are used for the diagnosis and treatment of sacroiliac joint pain. this study will compare ultrasound and fluoroscopy guidance for sacral lateral branch blocks. outcomes examined will include performance times and success rates.


Eligibility criteria:
inclusion criteria: * any consenting patient over 18 years of age, undergoing a diagnostic sacral lateral branch block for suspected sacroiliac joint related pain. exclusion criteria: * inability to consent, iodine or lidocaine allergy, pregnancy, coagulopathy (as defined by an international normalized ratio over 1.4, platelets under 100,000, or a documented bleeding disorder) and inability to visualize the target areas necessary for sensory testing (posterior superior iliac spine, dorsal aspect of sij) under ultrasound guidance.
extension study of the safety and efficacy of armodafinil treatment as adjunctive therapy in adults with major depression associated with bipolar i disorder

Conditions: Depression

Summary: the primary objective of this study is to evaluate the safety and tolerability of long term (6 months) armodafinil treatment as adjunctive therapy to mood-stabilizing medications in adults with bipolar i disorder.


Eligibility criteria:
key inclusion criteria: * the patient has completed 8 weeks of treatment in a cephalon-sponsored phase 3, double-blind study of armodafinil treatment in patients with major depression associated with bipolar i disorder. * the patient met criteria for enrollment in the previous double-blind study and, in the opinion of the investigator, is in need of continued treatment for depression. * during the previous double-blind study, the patient must have been taking 1 (or 2) of the following protocol-allowed mood stabilizers: lithium; valproic acid; olanzapine; quetiapine; aripiprazole; lamotrigine; risperidone; ziprasidone, (only if taken in combination with lithium, valproic acid, or lamotrigine). the following criteria must also be met: 1. the mood stabilizers must be taken in an oral formulation, with the exception of risperidone, which can be either in an oral or long-acting injection formulation. 2. the patient may be taking 2 protocol-allowed mood stabilizers only if 1 of the drugs is lithium, valproic acid, or lamotrigine. 3. the patient must be judged by the investigator to be compliant with treatment with the mood stabilizer(s). 4. the patient must be willing to continue treatment with the same protocol-allowed mood stabilizer(s) at dosages considered appropriate by the investigator. * the patient has a young mania rating scale (ymrs) total score of 14 or less at the enrollment visit. patients who have a ymrs score of 12 through 14 must be discussed with the medical monitor to determine their suitability for enrollment. key exclusion criteria: * the patient has any axis i or axis ii disorder apart from bipolar i disorder that became the primary focus of treatment during the double-blind study. * the patient has psychotic symptoms or had psychosis during the double-blind study. * the patient has current active suicidal ideation, is at imminent risk of self harm, or has a history of significant suicidal ideation or suicide attempt at any time in the past that causes concern at present. * the patient met criteria for alcohol or substance abuse or dependence (with the exception of nicotine dependence) during the double-blind study. * the patient has any history of homicidal ideation or significant aggression or currently has homicidal or significant aggressive ideation.

Keywords: bipolar i disorder
assessment of early-detection based on liquid biopsy in lymphoid malignancies

Conditions: Lymphoma

Summary: ascend-lym is a prospective, multi-center, observational study aimed at detecting early stage lymphoma and constrcuting prognostic model by combined assays of cfdna methylation and other biomarkers. the study will enroll approximately 493 participants including lymphoid malignancies and benign diseases.


Eligibility criteria:
inclusion criteria for all participants: * age 40-75 years at the day of consenting to the study. * able to provide a written informed consent. additional inclusion criteria for cancer participants: * no prior cancer treatment (local or systematic) prior to blood draw. * high suspicious or pathologically confirmed lymphoid malignancies within 42 days prior to blood draw. additional inclusion criteria for benign disease participants: * no prior radical treatment of the benign diseases prior to study blood draw * pathologically confirmed diagnosis of lymphoid benign diseases within 90 days prior to blood draw. exclusion criteria for all participants: * insufficient qualified blood samples. * during pregnancy or lactation. * recipient of organ transplant or prior non-autologous (allogeneic) bone marrow or stem cell transplant. * recipient of blood transfusion within 7 days prior to blood draw. * recipient of anti-tumor drugs to treat non-cancer diseases within 30 days prior to blood draw, such as rheumatic drugs (methotrexate, cyclophosphamide, or azathioprine), or endocrine drugs (tamoxifen). additional exclusion criteria for cancer participants: * with other known malignant tumors or multiple primary tumors. * lymphoid malignancies unable to comfirmed by imaging tests or pathological cancer diagnosis within 42 days after the blood draw. additional exclusion criteria for benign disease participants: * with other known malignant tumors or comfirmed lymphoid malignancies. * lymphoid benign diseases unable to comfirmed by imaging tests or pathological cancer diagnosis within 42 days after the blood draw.

Keywords: lymphoma, early detection, liquid biopsy
gut microbiome associated study of shanghai infants with jaundice

Conditions: Gastrointestinal Microbiome

Summary: the purpose of this study is to evaluate the effect of probiotics on the gut microbiome of infants with jaundice.

this study aims to examin the impact of probiotics administration during the process of infants jaundice treatment and recovery phase.the recovery phase.birth,7 days,14 days and 42 days data will be collected and put into analysis to provide some suggestions on the probiotics use in the clinical for the infants with jaundice.

Eligibility criteria:
inclusion criteria: * newborns with jaundice treated with blue light phototherapy exclusion criteria: * gestational weeks \<37 birth weight \<2500g or ≥4000g history of asphyxia anoxia at birth with infectious diseases treated with antibiotic with congenital metabolic diseases or hereditary diseases with gastrointestinal diseases

Keywords: probiotics gut microbiome infants jaundice
a phase 2 multicenter study of axicabtagene ciloleucel in subjects with relapsed/refractory indolent non-hodgkin lymphoma

Conditions: Follicular Lymphoma; Marginal Zone Lymphoma; Indolent Non-Hodgkin Lymphoma

Summary: this study will enroll approximately 160 adult participants who have relapsed or refractory (r/r) inhl to be infused with the study treatment, axicabtagene ciloleucel, to see if their disease responds to this experimental product and if this product is safe. axicabtagene ciloleucel is made from the participants own white blood cells which are genetically modified and grown to fight cancer. an objective response rate of 70% is targeted.

all enrolled participants will be screened for eligibility then will undergo leukapheresis to collect white blood cells for manufacturing. in preparation for the infusion with axicabtagene ciloleucel, participants will undergo conditioning chemotherapy with cyclophosphamide and fludarabine for 3 days to help the study treatment be effective. after the product is manufactured and conditioning chemotherapy period is complete, participants will be infused with axicabtagene ciloleucel and then monitored in a hospital for a minimum of 7 days. after completing at least 60 months (fl participants) or at least 24 months (mzl participants) of assessments in this study since the initial axicabtagene ciloleucel infusion and after agreement by the sponsor, participants will transition to a long-term follow-up (ltfu) study, kt-us-982-5968 where they will complete the remainder of the 15 year follow-up assessments.

Eligibility criteria:
key inclusion criteria: 1. individual has \[follicular lymphoma or marginal zone lymphoma that has progressed after at least 2 lines of treatment with combination chemoimmunotherapy\] (e.g. r-bendamustine, r-chop). 2. individual has \[measurable disease\]. 3. individual has no known presence or history of central nervous system (cns) involvement by lymphoma. 4. if individual is on conventional systemic therapy or systemic inhibitory/stimulatory immune checkpoint therapy, individual is able to stop conventional therapy 2 weeks or 5 half-lives, whichever is shorter, or immune checkpoint therapy 3 half-lives prior to planned leukapheresis. 5. individual has eastern cooperative oncology group (ecog) performance status of 0-1 and adequate renal, hepatic, pulmonary, and cardiac function 6. individual is not pregnant or breastfeeding (female individuals only) and is willing to use birth control from the time of consent through 12 months following chimeric antigen receptor (car) t cell infusion (both male and female individuals). key exclusion criteria: 1. transformed follicular lymphoma (fl) or marginal zone lymphoma (mzl) 2. small lymphocytic lymphoma 3. histological grade 3b fl 4. individual will have undergone autologous transplant within 6 weeks of planned leukapheresis or has undergone allogeneic transplant. 5. individual has evidence of involvement of the heart by lymphoma or requirement for urgent therapy due to ongoing or impending oncologic emergency (e.g. mass effect, tumor lysis syndrome, etc.) note: other protocol defined inclusion/exclusion criteria may apply.
influence of caloric restriction and resveratrol in the sirtuin system in women and men aged 55 to 65 years

Conditions: Vascular System Injuries; Lipid Metabolism Disorders; Endothelial Disfunction

Summary: women have a natural protection that gives them greater longevity. one hypothesis most commonly used is the estrogen protection in the premenopausal period. however many studies of various forms of hormone replacement therapy proved ineffective in promoting additional protection for women. thus, it is discussed other ways of protection associated with longevity in women. of these, the sirtuin system was found in several animal studies to be associated with longevity. this system also showed, through the involvement of several metabolic pathways, an important protection against the process of atherosclerosis. but the activity of this system in humans is unknown and if it is more active in women than in men. the study's main objectives are to analyze this system in healthy 24 women and 24 men aged 55 to 65 years, and their influence on the main metabolic pathways related to longevity and the process of atherosclerosis. the research protocol includes analysis of the influence of sirtuin (sirt1) in vascular reactivity, lipid profile, antioxidant capacity, markers of inflammation and homeostasis, before and after the interventions with caloric restriction or resveratrol administration. it is expected of this study mechanistic conclusion for longevity and possible clinical applications in the mechanism of atherosclerosis prevention.

after a washout period of 15 days without medication, men and women will be randomized to the group of calorie restriction or resveratrol so that in 24 individuals (12 women and 12 men) will be given a hypocaloric diet (1000 calories per day) and the remaining 24 individuals (12 women and 12 men), a daily pill of 500mg of resveratrol. in the two moments, after the washout period and before the intervention (baseline) and after 30 days of intervention (final) will evaluate the clinical, laboratory and vascular reactivity of all subjects.

Eligibility criteria:
inclusion criteria: * clinical history, physical examination and electrocardiogram normal exclusion criteria: * premenopausal women (less than 1 year of natural amenorrhea) * body mass index ≥ 35 kg/m2 * smoking * severe hypertension (diastolic blood pressure ≥ 110 mmhg) * severe dyslipidemia (triglycerides ≥ 500mg/dl, total cholesterol ≥ 300mg/dl) * diabetes * previous using previous statins or hormone replacement therapy. other exclusion criteria are: chronic renal failure (serum creatinine ≥ 2.0 mg / dl), hepatic, endocrine, hematologic, respiratory or metabolic clinically significant.

Keywords: sirtuin atherosclerosis longevity calorie restriction resveratrol vascular reactivity
african american depression intervention trial (aadi)

Conditions: Major Depressive Disorder

Summary: primary aim 1: examine effectiveness of the oh happy day class (ohdc) compared to the coping with depression (cwd)in increasing retention, adherence, engagement, satisfaction, and treatment-seeking. the investigators hypothesize the ohdc compared to the cwd will result in greater increases in: 1a. retention, 1b. adherence, 1c. engagement, and 1d. satisfaction at the middle and end of the intervention, and 2.e. greater increase in treatment-seeking 3-, 6-, 9-, and 12- months post-intervention. outcome measures: logs: attendance, homework completion, class-participation level; client satisfaction inventory; and cornell service index. primary aim 2: examine effectiveness of the ohdc in reducing symptoms of depression at the middle and immediate end of the intervention, and 3-, 6-, 9-, and 12- months post-intervention. the investigators hypothesize the ohdc will result in greater reduction in depressive symptoms compared to the cwd at 3-months post-intervention. outcome measures: center for epidemiologic studies depression scale and quick inventory of depression symptoms. secondary aim 3: examine the effectiveness of the ohdc in improving self-reports of mental and physical health status and reducing self-reports of perceived disability. the investigators hypothesize the ohdc compared to the cwd will result in greater self-report of: 3a. improved mental and physical health status, and 3b. reduced self-report of disability at the immediate end of the intervention and 3-,6-, 9-, 12- months post-intervention. outcome measures: sf-12 health survey, and world health organization disability assessment schedule. public health impact: based on cai research, the ohdc has the potential to be four times more effective than the cwd. if our hypotheses are proven, the ohdc will be the first evidence-based culturally adapted depression intervention designed specifically for african american men and women between the ages of 30-60.


Eligibility criteria:
inclusion criteria: * inclusion criteria. self-identified african-american men and women, between the ages of 30 to 60, with symptoms of depression as evidenced by data from the composite international diagnostic interview 2.1 (cidi). although age of inclusion is broad, our pilot studies have shown positive outcomes with mixed aged groups exclusion criteria: * exclusion criteria. individuals will be excluded from the study if they have: (1) self-reported alcohol or other drug abuse/dependence, (2) major psychotic illnesses, such as schizophrenia as evidenced by results of the cidi, (3) self-reported changes in antidepressants (dosage or type) less than 6 weeks prior to participating in the study, (4) self-report of current psychotherapy treatment, or (5) self-report of current suicidal ideations (our psychiatrist will conduct additional suicide risk assessment and facilitate referral for appropriate care.

Keywords: depression
perioperative coagulopathy in patients undergoing cytoreductive surgery and hipec intraperitoneal chemotherapy (hipec)

Conditions: Coagulation Disorder; Carcinomatosis

Summary: cytoreductive surgery (crc) with intraperitoneal hyperthermal chemotherapy (hipec) has been shown to improve survival in selected patients with peritoneal carcinomatosis. 51% of patients are transfused due to the high intraoperative blood loss caused by surgery and the appearance of a perioperative coagulopathy attributed to the loss of proteins into the peritoneal cavity, the high fluid turnover and possibly the action of hyperthermic chemotherapy. so far, the haemostatic changes described consist of a decrease in the levels of antithrombin iii and the platelet count, as well as in alterations of the usual coagulation tests. conventional coagulation tests analyze only the plasmatic phase of coagulation while viscoelastic tests, such as rotational thromboelastometry (rotem), reproduce the global coagulation process much more faithfully, keeping good correlation with perioperative bleeding. objetive: the platelet, coagulation, von willebrand and factor xiii levels and function have not been consistently investigate in pre-established (fix) time periods in patients undergoing elective crc with hyperthermia. this prospective observational study aimed at investigating the variations of the values of estándar coagulation test, rotem parameters, platelet function assay (pfa-100), von willebrand and factor xiii at baseline (before surgery) and after 4h and 48 after surgery in 40 patients undergoing crc. a control group (n=40 blood donors) will be also obtained by baseline comparasion and to obtain local reference ranges.

this prospective observational study aimed at investigating the variations of the values of estándar coagulation test, rotem parameters, platelet function assay (pfa-100), von willebrand and factor xiii at baseline (before surgery) and after 4h and 48 after surgery in 40 patients undergoing crc. a control group (n=40 blood donors) will be also obtained by baseline comparasion and to obtain local reference ranges.

Eligibility criteria:
inclusion criteria: 1. - consecutive patients with peritoneal surface malignancy treated with cytoreductive surgery and hipec in the department of surgery of virgen del rocio general hospital 2. -all patients gave written informed consent. 3. -age above 18 years and karnofsky performance status scale 450% exclusion criteria: 1. - exclusion criteria: were severe cardiovascular or respiratory disease, 2. - lower hemoglobin than 10,0 g/dl , platelet count 100,000/mm3, 3. - renal or hepatic failure, 4. - pregnancy, 5. - multiple partial intestinal obstruction or extensive involvement of the surface of the small bowel as well as distant and non-resectable metastases.