Kornimate/medical-research-clean huggingface dataset:
presept study: evaluation of sept9 biomarker performance for colorectal cancer screening

Conditions: Colorectal Cancer

Summary: the purpose of this study is to collect blood specimens and clinical data from screening guideline eligible individuals designated by their physician to receive a screening colonoscopy, and to evaluate the performance of a colorectal cancer-specific dna methylation biomarker for detection of colorectal cancer in this cohort. based on the outcome of the colonoscopy, polypectomy, biopsy and surgical tissue histopathology, the clinical utility of septin 9 as colorectal cancer screening test will be evaluated.

the study is designed as a prospective, open enrollment clinical investigation involving multiple clinical study sites in the united states and germany. subjects will be competitively enrolled at multiple sites until at least 50 invasive colorectal adenocarcinoma cases identified by screening colonoscopy and verified by clinical and histopathological examination have been enrolled. the primary objective of the investigation is to evaluate and describe the clinical performance of the septin 9 biomarker for detecting the 50 individuals with invasive colorectal adenocarcinoma identified in this population representative of the us screening guideline eligible population. secondary objectives will be to evaluate and describe performance characteristics of the biomarker in individuals with adenomatous polyps 10 mm or larger, flat lesion (s) or non-invasive adenocarcinoma. collaborating sites will identify and contact patients scheduled for screening colonoscopy. these patients may be screened by the pi or designee to determine the patients' appropriateness for, and interest in, study participation. study site personnel will meet with patients meeting eligibility guidelines and offer them participation. patients interested in participation and who provide written informed consent will be enrolled as subjects in the study.

Eligibility criteria:
inclusion criteria: * informed consent provided * capable of providing adequate health history * age 50 or older at time of colonoscopy (colorectal screening guideline eligible) * accessible for blood draw prior to start of bowel preparation for colonoscopy * first large bowel endoscopy in lifetime exclusion criteria: * anorectal bleeding or hematochezia within last 6 months for which patient sought medical attention * known iron deficiency anemia in the last 6 months for which patient sought medical attention * previous history of colorectal polyps or crc * high risk for colorectal cancer (2 or more 10 relatives with crc; 1 or more 10 relative(s) \< 50 years with crc; known hnpcc or fap)

Keywords: colorectal cancer early detection methylation, biomarker
prognostic interest of leucocyte immunophenotyping during the acute phase of sepsis

Conditions: Sepsis With Acute Organ Dysfunction

Summary: septic shock is still a major cause of death in icu. sepsis diagnosis is linked with many clinical, hemodynamic and biological criteria which have a low sensitivity and specificity if they are considered separately. the extensive experimental data which have been published contrast with the hematological data collected by the physician at patient's bedside especially regarding neutrophils and platelets levels. when there is no obvious clinical sign, a biological tool reflecting the patient's immune status could be useful to understand the physiopathology of sepsis and to predict the progression of the disease in the patient. on the long-term it could also help to define management strategies.


Eligibility criteria:
inclusion criteria: * patient older than 18 years old * patient with two criteria of systemic inflammatory response syndrome and a progressive infection which is clinically or microbiologically documented exclusion criteria: * pregnancy, * progressive solid cancer, * hiv infection, * history of blood or inflammatory disease, * long-term immunosuppressive treatment

Keywords: the acute phase of sepsis multiparameter 8-color flow cytometry
simplified patient care strategy in decreasing early death in patients with acute promyelocytic leukemia

Conditions: Acute Promyelocytic Leukemia With PML-RARA; t(15;17)

Summary: this clinical trial studies how well simplified patient care strategy works in decreasing early death in patients with acute promyelocytic leukemia. implementing simplified acute promyelocytic leukemia guidelines along with support from acute promyelocytic leukemia experts may decrease deaths and improve survival.

primary objectives: i. to evaluate if the proposed patient care strategy, that includes use of simplified guidelines along with acute promyelocytic leukemia (apl) expert support, decreases the one-month induction mortality rate from 30% to under 15%. secondary objectives: i. to assess the overall survival 1 year after accrual is completed. ii. to assess incidence and severity of differentiation syndrome. iii. to correlate outcomes with time to initiation of all-trans retinoic acid (atra) from diagnosis or suspicion of diagnosis. iv. to compare outcomes between academic and community centers separately. v. to evaluate factors associated with outcome. outline: patients receive standard of care treatment for apl. patients and doctors regularly discuss with an apl expert to identify and mange treatment. after diagnosis, patients are followed up for 1 year.

Eligibility criteria:
inclusion criteria: * confirmed to have a diagnosis of apl, which is defined as: * positive t(15:17) by fluorescence in situ hybridization (fish) or conventional karyotype * positive promyelocytic leukemia/retinoic acid receptor pml/rar alpha by polymerase chain reaction (pcr) * patients must accept treatment and supportive care guidelines * referrals must be made as early as possible but no later than 5 calendar days after atra therapy is initiated; consent can be obtained up till day 7 or earlier * co-management can be started as soon as referral is made including weekends; the physician at the outlying facility should make every effort to call the apl expert at the first suspicion of apl
cd16+ monocytes in coronary heart disease (chd)

Conditions: Coronary Heart Disease

Summary: monocytes may be separated into phenotypically and functionally distinct cell types by the presence or absence of the lipopolysaccharide receptor cd14 and the fcγ-receptor cd16. the investigators hypothesize that the total numbers of cd16+ monocytes are significantly related to cardiovascular outcome in patients with angiographically proven coronary heart disease.


Eligibility criteria:
inclusion criteria: * angiographically proven coronary heart disease * age \> 18 years exclusion criteria: * life expectancy \< 12 months * inability to participate in the trial (to give written informed consent)

Keywords: -cd16+ monocytes
characteristics of different types of safety lancets on blood volume and perceived pain in male and female volunteers

Conditions: Healthy

Summary: the study was a randomized, single blind, uni-center pivotal study in male and female healthy volunteers, to determine capillary blood volume and pain perception obtained in a process of puncturing with different safety lancets. a group of one hundred (100) healthy caucasian male and female subjects (aged \> 18 to \< 65 years old was randomized ) who were in good physical and mental condition. the subjects had 4 (four) fingers (two fingers from each hand) lanced each with a different type of safety lancet. overall, 4 (four) different safety lancets were investigated per each subject. overall, 16 (sixteen) different safety lancets (4 different safety lancets per one subject) were investigated, the capillary blood volume and pain were measured.


Eligibility criteria:
inclusion criteria: * willing to sign the informed consent. * male and female volunteers. * age between 18 and 65 inclusive. * able to communicate well with the investigator and comply with the requirements of the study. * volunteers who are in good physical and mental health. exclusion criteria: * pregnancy or breastfeeding (self-reported). * confirmed or suspected malignant cancer history of poor blood circulation. * any skin condition on his or her fingers that prevents blood sampling. * anxiety with needles or finger pricks. * clotting disorders (including bleeding) in medical history. * neuropathy or other condition affecting sensation in the hands. * history of blood borne infection (e.g., hiv, hepatitis b or c, syphilis, malaria, babesiosis, brucellosis, leptospirosis, arboviral infections, relapsing fever, t lymphotropic virus type 1, creutzfeldt-jakob disease). * currently participating in another study. * history of drug or alcohol abuse within the 12 months prior to screening or evidence of such abuse. * intake of alcohol within 48 hours prior to the start of the study (self-reporting). * donation or loss of 400 ml or more of blood within 4 weeks prior to the start of the study. * any other condition that in the investigator opinion may negatively influence subject's participation in the study. * intake of medicines that affect blood coagulability (including anticoagulants such as vitamin k, antivirals and anticoagulants such as heparin, aspirin, thrombin inhibitors, vitamin k antagonists).

Keywords: safety lancets lancet capillary blood capillary blood sampling blood volume pain
promoting physical activity for persons with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: the purpose of this study was to determine whether a group wellness intervention or individualized physical rehabilitation was more effective in improving health and physical activity in persons with multiple sclerosis.

evidence from this study shows that both interventions were effective in improving health and physical activity in persons with multiple sclerosis. the results also show that participants may benefit more physically from individualized physical rehabilitation and more mentally from group wellness interventions. interventions that combine individualized therapeutic exercise with group health education might be most effective for persons with multiple sclerosis.

Eligibility criteria:
inclusion criteria: * a physician-confirmed diagnosis of ms * between the ages of 18 to 75 years * ability to ambulate 25 meters with or without the use of an adaptive aide exclusion criteria: * pregnant * cardiovascular disease * had fallen more than twice in the past month * significant cognitive deficits

Keywords: chronic disabling condition comparative evaluation physical activity physical therapy rehabilitation
efficacy and treatment related toxicity study of a new regimen for lymphoma

Conditions: Non-Hodgkin's Lymphoma; Hodgkin's Disease

Summary: this is an open label pilot study of 40 evaluable patients receiving vinorelbine-gemcitabine combination chemotherapy with filgrastim support in an outpatient setting. participating patients at the time of registration will have measurable relapsed or primary refractory lymphoma.

patients suffering from lymphoma (a type of cancer of the white blood cells called lymphocytes) have less chance of cure if they are refractory to initial chemotherapy or relapse after receiving initial chemotherapy when compared to patients who are responsive to and do not relapse following initial chemotherapy. the standard of care, therefore, for these patients is to undergo some form of bone marrow transplant procedure. however, before this can be considered most patients require chemotherapy to control the lymphoma and to determine whether the lymphoma is still sensitive to alternative types of chemotherapy (salvage chemotherapy). currently used types of salvage chemotherapy require significant periods of inpatient hospitalisation and are associated with significant haematological toxicities (low blood counts with the associated risks of infection and bleeding and the need for blood and platelet transfusions). two new chemotherapy drugs, vinorelbine and gemcitabine, have both shown encouraging efficacy against lymphoma when used alone for patients with heavily pretreated lymphoma. furthermore, they can be given in an outpatient setting and are usually not associated with significant haematological toxicity. all the patients participating in this study have been diagnosed with relapsed or refractory lymphoma and have been offered treatment with vinorelbine and gemcitabine as an alternative to inpatient salvage chemotherapy.

Eligibility criteria:
inclusion criteria: * age 18 to 70 years * relapsed or primary refractory non-hodgkin's lymphoma (nhl) or hodgkin's disease (hd) * measurable disease (clinically or radiologically) * ecog 0 - 2 * written informed consent exclusion criteria: * bilirubin \> 50μmol/litre unless secondary to lymphoma * creatinine \> 2 x upper limit of normal unless secondary to lymphoma, * absolute neutrophil count \<0.5 x 109/litre and / or platelets \< 50 x 109/litre unless secondary to lymphoma * isolated bone marrow disease * known sensitivity to e coli derived preparations

Keywords: lymphoma
study of 24 hour blood pressure and the association to complications to type 1 diabetes

Conditions: Type 1 Diabetes; Hypertension

Summary: the aim of the study is to evaluate the prevalence of abnormal nocturnal blood pressure (bp) in patients with type 1 diabetes. the investigators wish to gain knowledge on the relation between central and peripheral 24 hour bp and a possible association to late complications in diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes * more than 18 years of age exclusion criteria: * end stage renal disease (esrd) * dialysis * other kidney disease than diabetic nephropathy

Keywords: nocturnal blood pressure dip complications ambulatory blood pressure
procalcitonin (pct) as a diagnostic marker of bacterial infection in the patients admitted for fever and/or inflammatory syndrome to the internal medicine department

Conditions: Systemic Inflammatory Response Syndrome; Fever

Summary: levels of pct (a marker of bacterial infection) are highest during sepsis: in fact, pct is normally produced by the c cells in the thyroid gland. pct was initially studied by assicot1 for distinguishing between bacterial meningitis and viral meningitis. the calc-i gene codes for pct. in the absence of infection, the extrathyroid mrna expression of the calc-i gene is repressed, and expression is restricted to neuroendocrine thyroid and pulmonary cells. infection induces the ubiquitous expression of the calc-i gene. pct is not transformed into calcitonin in parenchymatous tissues. in a context of sepsis, the whole body acts as a neuroendocrine gland. sepsis upregulates pct mrna expression much more than that of other cytokines. pct is used in critical care departments as a diagnostic marker, a guide to treatment (antibiotics are withdrawn if the level falls) and a prognostic marker. there are few data on the diagnostic use of pct in an internal medicine department. the available studies yielded contradictory results and only one prospective study has been performed . the objective was to study pct in non-infectious, inflammatory pathologies and to establish whether pct could distinguish infections from other inflammatory pathologies in patients in an internal medicine department. in a roc curve analysis, a pct threshold of 0.35 µmol/l gave the greatest specificity (88%) and sensitivity (72%). other studies have been performed but featured small sample sizes and a retrospective design. of the various studies performed in internal medicine departments, none included patients presenting with a suspected bacterial infection (according to the clinician's interpretation) and lacking information on their bacterial status. in fact, these diagnoses are a core component of hospitalisation in internal medicine departments for fever or inflammatory syndrome. the investigators intend to include all patients, including those lacking information on their microbiological status).


Eligibility criteria:
inclusion criteria: * patients aged 18 or over hospitalized in the internal medicine department at amiens university hospital, presenting with fever (\>38.5°c) and/or inflammatory syndrome (crp \>5 mg/l) and having given their consent will be included. exclusion criteria: * haemodialyzed patients. * age under 18. * legal guardianship. * refusal by the patient, or inability to give consent. * patients on antibiotics for more than 12 hours at the time of the pct assay (the half-life of pct is 22 hours, and the level falls rapidly when antibiotics are administered). * pct assays more than 12 hours after hospitalisation.

Keywords: procalcitonin bacterial infection
thorathic fluid content as an early predictor of weaning from mechanical ventilation in acute respiratory distress syndrome

Conditions: Acute Respiratory Distress Syndrome

Summary: thorathic fluid content measurement using indirect cardiometry is required for prediction of weaning from mechanical ventilation in cases of acute respiratory distress syndrome and its value in sucsess weaning


Eligibility criteria:
inclusion criteria: * patients with ards on ventilator for more than 48 hr. proceed for extubation exclusion criteria: * heart, renal, hepatic failure obesity , pregnancy pneumothorax, pneumonia, hemorrhage
cortical modulation of acute post-thoracotomy pain with transcranial direct current stimulation

Conditions: Pain, Postoperative

Summary: the primary objective of this single center, prospective, randomized, double blind clinical trial is to evaluate the effectiveness of anodal transcranial direct current stimulation (tdcs) combined with patient controlled analgesia (pca) morphine, on intravenous morphine use for postoperative analgesia after thoracotomy. the intervention group will receive treatment with anodal tdcs, whereas the control group will receive sham stimulation.

tdcs has been used for treatment of chronic pain states, but experience with the use of tdcs for treatment of acute postoperative pain is limited. tdcs has been used for postoperative analgesia after lumbar spine surgery, total knee arthroplasty and for post-procedural pain after endoscopic retrograde cholangiopancreatography. this study investigates the effects of tdcs vs. sham stimulation combined with iv morphine pca on postoperative morphine consumption for analgesia after thoracotomy for lung cancer. patients with malignant lung disease requiring thoracotomy will be randomly assigned to active stimulation or sham stimulation in a double-blind, sham-controlled, parallel design clinical trial. each group will receive iv morphine pca and tdcs vs. iv morphine pca and sham stimulation daily, starting with arrival in the post-anesthesia care unit on the day of surgery and continuing for the first four postoperative days. anodal tdcs with direct current at intensity 2 ma will be delivered for 20 minutes on five consecutive days, whereas sham stimulation will last for 30 seconds. morphine consumption, the number of analgesia demands, and pain intensity at rest, during movement and with cough will be recorded at predetermined time intervals as follows: after surgery, when vas pain score at rest falls below 30 mm, tdcs will be applied. vas pain will be measured immediately before the intervention (t0) and immediately after the intervention (t1), and then regularly every one hour for the four hours (т2-т5), and then every six hours (т6-т9) for five days.

Eligibility criteria:
inclusion criteria: * subject is willing and able to provide written informed consent, * subject is 18-80 years old, * subject needs thoracotomy for confirmed malignant lung disease, * subject is extubated in the operating room exclusion criteria: * subject is pregnant * subject is in treatment for psychiatric disease * subject is in treatment for neurological disease * subject is in treatment for chronic pain * subject has history of current or past alcohol or street drug abuse * subject has received chemotherapy * subject has history of previous thoracic or cardiac surgery * subject is allergic to medications that will be used in the study * subject has pacemaker or automatic implantable cardioverter/defibrillator * subject has implants or any other devices in the head, the spinal cord or peripheral nerves * subject has confirmed brain lesion, including tumor or metastasis

Keywords: transcranial direct current stimulation pain postoperative thoracotomy
autologous bronchial basal cells transplantation for treatment of chronic obstructive pulmonary disease (copd)

Conditions: Chronic Obstructive Pulmonary Disease

Summary: chronic obstructive pulmonary disease (copd) is a kind of chronic bronchitis or emphysema with characteristics of long-term poor airflow, resulting in chronic pulmonary heart disease, chronic respiratory failure or even death. anatomically, the pulmonary bronchus structures in copd patients are damaged and cannot be repaired by recent clinical treatment so far. this study intends to carry out an open, single-armed, phase i/ii clinical trial to investigate whether bronchial basal cells can regenerate damaged lung tissue. during the treatment, bronchial basal cells will be isolated from patients' own bronchi and expanded in vitro. after careful characterization, cultured cells will be transplanted autologously into the lesion by fiberoptic bronchoscopy. the safety and efficacy of the treatment will be monitored by measuring the key clinical indicators.


Eligibility criteria:
inclusion criteria: * aged between 40 to 75; * diagnosed with copd according the guideline (a. with symptoms of productive cough, sputum production or shortness of breath; b. with poor airflow as indicated by fev1\<70% predicted value and fev1/fvc \< 0.7 in pulmonary function test; c. with exclusion of other pulmonary disease by ct or blood examination.); * clinically stable for more than 4 weeks; * tolerant to bronchofiberscope; * written informed consent signed. exclusion criteria: * pregnant or lactating women; * patients positive for syphilis, hiv; * patients with malignant tumor; * patients with serious significant pulmonary infection and need anti-infection treatment; * patients with serious heart disease(nyha class ⅲ-ⅳ); * patients with a history of abusing alcohol and illicit drug; * patients participated in other clinical trials in the past 3 months; * patients assessed as inappropriate to participate in this clinical trial by investigator.