Kornimate/medical-research-clean huggingface dataset:
clinical research on dynamic monitoring mrd via plasma ctdna after systemic therapy of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: this study aims to combine biomarker characteristic atlas and ctdna detection technology to establish a precise standard scheme for minimal residual diagnosis of liver cancer after surgery and systemic treatment.

this study is a prospective, single-blind, randomized, controlled, single-center study. the patients with liver cancer are recruited after surgery or systemic treatment. intraoperative cancer and para-cancer tissues of surgical patients are collected, and peripheral blood of all patients after multiple follow-up visits before and after treatment are also collected. the established detection method and model are used to detect blood ctdna of patients with liver cancer after treatment, and the follow-up data are collected to observe the correlation between the genomic characteristics of plasma at multiple follow-up points after treatment and the recurrence or progression after treatment. the sensitivity and specificity of ctdna detection method is calculated to predict the risk of relapse or progression after treatment.

Eligibility criteria:
inclusion criteria: 1. age 18-80 years old (including 80 years old), gender is not limited; 2. patients diagnosed with primary hcc; 3. ecog score ≤1; 4. no previous malignant tumors, including liver cancer; 5. before blood collection, the patient had not received any treatment related to liver cancer, including surgery, transplantation, radiotherapy, chemotherapy, etc.; 6. survival period of ≥3 years as initially assessed by researchers; 7. those who are fully aware of this study and voluntarily sign the informed consent. exclusion criteria: 1. patients diagnosed with esophageal cancer, gastric cancer, colorectal cancer, lung cancer, pancreatic cancer, breast cancer and other malignant tumors; 2. patients who have received major surgical treatment such as blood transfusion or transplantation within 3 months; 3. participate in other interventional clinical investigators within 3 months; 4. pregnant or lactating women; 5. patients with autoimmune diseases, genetic diseases, mental disorders/disabilities, substance abuse and other diseases deemed unsuitable for participation in the study by the researchers; 6. poor compliance, according to the judgment of the researcher can not complete the study.

Keywords: hcc mrd ctdna mutation methylation
evaluate the efficacy of insulin patients with type 1 diabetes

Conditions: Diabetes Mellitus, Type 1

Summary: a study to test for non-inferiority of preprandial hiip \[also known as air® inhaled insulin powder\]\[air® is a registered trademark of alkermes,inc.\] compared with preprandial injectable insulin (insulin lispro) with respect to hba1c after 6 months of treatment in patients with type 1 diabetes mellitus. this study is designed also to examine insulin antibody levels in air insulin -treated patients compared with injectable insulin-treated patients with type 1 diabetes. the present study is intended to determine if preprandial air insulin is non-inferior to preprandial injectable insulin (insulin lispro) with respect to mean change in hba1c from baseline to endpoint at 6 months in patients with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * type 1 diabetes for at least 24 months * have an hba1c less than or equal to 11% * patients who are on an insulin regimen involving 2 or 3 preprandial injections per day for at least 2 months * non-smoker exclusion criteria: * require a daily total insulin dosage greater than 150 u at screening * patients who have a current or past history of asthma, chronic obstructive pulmonary disease, other clinically relevant pulmonary disease * systemic glucocorticoid therapy * clinical signs or symptoms of liver disease, acute or chronic hepatitis * history of lung transplantation and/or lung cancer * diagnosed with pneumonia in the 3 months prior to screening * history of renal transplantation * active or untreated malignancy
robot-assisted rehabilitation of the upper limb in acute and subacute post-stroke patients

Conditions: Stroke; Cerebrovascular Accident; Upper Extremity Paresis

Summary: the goal of this study is to determine if robot aided rehabilitation therapy can be equivalent to or more effective than conventional rehabilitation therapy at promoting functional recovery of the paretic upper limb in acute and subacute stroke patients.

the study aims to test a robotic rehabilitation protocol which involves the use of a robotic device (nerebot) as an alternative to the conventional rehabilitation treatment. nerebot is a 3-degree-of-freedom robotic device, which can be programmed by the therapist to perform repetitive assistive movements (flexion and extension, adduction and abduction, pronation and supination, circular) of the upper limb (shoulder and elbow), combined with a visual and acoustic display. acute and subacute stroke patients (≤20 days post-stroke) will be randomized into two groups with a procedure by a computer program: the experimental group (eg) and the control group (cg). both groups will receive a total daily treatment time of 120 minutes for five days a week and for five weeks. the eg will perform the conventional functional rehabilitation (proprioceptive exercises, verticalization, gait training, paretic hand and wrist mobilization, without mobilizing the proximal paretic arm) and occupational therapy for 80 minutes a day, while the proximal paretic arm will be treated by nerebot for 40 minutes a day. for the cg, nerebot therapy is substituted by 40 minutes of conventional mobilization of the proximal paretic arm by the therapist.

Eligibility criteria:
inclusion criteria: 1. recent unilateral single stroke (ischemic or hemorrhagic) verified by brain ct or mri; 2. sufficient cognitive and language skills to understand the instructions of the operator (assessed by modified mini-mental state examination \> 21); 3. patients with upper limb paralysis (motor power score between 8 and 12); 4. written informed consent signed by the patient (or an authorized representative). exclusion criteria: 1. cardiovascular instability (severe uncontrolled hypertension, severe coronary artery disease, etc.) or orthopedic, or neurological conditions; 2. presence of multiple cerebrovascular lesions (usually the result of many ischemic episodes in the past); 3. early appearance of marked spasticity (≥ 3 according to ashworth scale); 4. joint pain or limited joint range of motion (rom) of the upper limb that results in the inability to complete the protocol; 5. severe neuropsychologic impairment (global aphasia, severe attention deficit or neglect), affecting the patient's ability to follow instructions;

Keywords: cerebrovascular accident hemiparesis recovery of function rehabilitation robotics subacute therapy training
a study of biomarkers of mild traumatic brain injury

Conditions: Mild Traumatic Brain Injury

Summary: patients with mild traumatic brain injury (mtbi) represent a burden of patients admitted to the emergency department. according to the guidelines, a cerebral ct scan is indicated after mtbi according to the specific conditions. however, variability exists regarding the respect of these ct scan indications, and less than 10% of patients will have visible brain lesions on ct scan. recently, serum glial fibrillary acidic protein (gfap) and ubiquitin c-terminal hydrolase-l1 (uch-l1) biomarkers have shown ability to differentiate normal and abnormal ct scan findings after mtbi. these encouraging results prompted us to launch a prospective study using automated and quick measurements of gfap and uch-l1 biomarkers to validate these findings.


Eligibility criteria:
inclusion criteria: * patients \>18 years old (france) * mild tbi (gcs 13-15 on admission) within 12 hours after injury * indication of brain ct scan: * neurological focal deficit * anterograde amnesia * glasgow coma scale score \<15 after 2 hours post-tbi * suspicion of vault depression fracture * fracture of the basal skull * persisting nausea, vomiting or headache * post-tbi seizures * pre-injury treatment with antithrombotic drugs * loss of consciousness or amnesia with age \>65 years, fall \>1m or hit pedestrian * other condition requiring ct scan according to the in-charge physician. exclusion criteria: * gcs 3-12 on admission * time of injury unknown * time to injury exceeding 12 hours * primary admission for non-traumatic neurological disorder (e.g., stroke, spontaneous intracranial hematoma) * penetrating head trauma * patient with mechanical ventilation * pre-injury neurological disorder affecting the assessment of neurological outcome: dementia, parkinson's disease, multiple sclerosis, seizure disorder, brain tumor, and history of neurosurgery, stroke or transient ischemic attack (tia) within the last 30 days * venipuncture not feasible * no realization of brain ct-scan * subject under judiciary control * pregnant or breastfeeding woman * subject in exclusion period of another study
an early phase clinical trial to evaluate the feasibility of cest mri in patients with early stage breast cancer

Conditions: Breast Cancer

Summary: evaluate the feasibility of translating preclinical chemical exchange saturation transfer (cest) mri protocol designed to estimate tumor extracellular ph (phe) to a clinical mri scanner in women with early stage breast cancer. assays are used to quantify tumor acidosis.

those involved in the treatment of patients with breast cancer have pioneered the field of personalized cancer therapy through the use of targeted therapies and their associated biomarkers. assays to quantify tumor acidosis and hypoxia are hypothesized to potentially represent such biomarkers. however there is currently no gold standard for measuring either. this trial will evaluate the feasibility of translating preclinical chemical exchange saturation transfer (cest) mri protocol designed to estimate tumor extracellular ph (phe), to a clinical mri scanner in women with early stage breast cancer. this trial will generate preliminary data regarding the feasibility of this imaging technique. if successful, in future studies cest mri may serve as an imaging biomarker for acidosis and hypoxia.

Eligibility criteria:
inclusion criteria: * newly diagnosed infiltrating ductal carcinoma (idc) of the breast * \>= 1.0 cm primary tumor * calculated creatinine clearance \>= 50 ml/min * willing and able to provide informed consent * age ≥ 18 years * ecog performance status 0-2 * informed of the investigational nature of this study exclusion criteria: * allergy to iodinated contrast agent * use of metformin, aminoglycosides, other nephrotoxic medications, or daily use of nsaids * diabetes mellitus * history of severe claustrophobia * presence of electrically, magnetically, or mechanically activated implants including cardiac pacemakers, cochlear implants, magnetic surgical clips or prosthesis that would preclude mri * use of \> 1 antihypertensive drug * pregnancy or breastfeeding * paraproteinemia syndromes or multiple myeloma * collagen vascular disease * active hyperthyroidism * active pharmaceutical treatments for cancer

Keywords: breast cancer cest mri
transcutaneous breast cancer diagnosis by canine odorology

Conditions: Breast Cancer

Summary: patient with an indication of interventional percutaneous procedure for characterization of a breast lesion, palpable or not, classified as category 4 or 5, according to the breast imaging (bi) report and data system of the american college of radiology (rads) classification detected at mammography and/or breast ultrasound examination.


Eligibility criteria:
inclusion criteria: 1. women 18 years and older, with one or more ipsilateral mammary lesion(s), palpable or not, detected at mammography and/or ultrasound and with at least one lesion classified as bi-rads® category 4 or 5 with an indication of percutaneous sampling (cytology, microbiopsies, macro-biopsies) ; 2. benefit from the national social security ; 3. signature of the informed consent of the study ; 4. there is no contraindication for the person to simultaneously participate to another research program and there is no exclusion period planned after the study. exclusion criteria: 1. patient with bilateral breast lesions classified as bi-rads® category 4 or 5; 2. patient with breast implant(s); 3. patient with a personal history of breast surgery for benign lesion(s) of the concerned breast operated less than 4 weeks before the date of inclusion in this study; 4. patient with a personal history of cancer (in situ or invasive) less than 5 years before inclusion whatever the anatomical site including cutaneous basal cell carcinoma; 5. patient with a personal history of punctures and/or percutaneous breast biopsies of the concerned breast less than 4 weeks before inclusion; 6. patient with a breast skin ulceration; 7. patient under insulin (risk of sudation that may impair compress sample); 8. concomitant antibiotics or corticoids taken one week before inclusion in the study; 9. patient with a current viral infection (fever); 10. persons under guardianship or deprived of liberty; 11. impossibility to submit to the medical monitoring expected by the study for geographical or severe psychological reasons.

Keywords: breast cancer dog detection volatile organic compounds
non-invasive spinal cord stimulation for spasticity control and augmentation of voluntary motor control in individuals with multiple sclerosis

Conditions: Multiple Sclerosis

Summary: epidural spinal cord stimulation (scs) is currently regarded as one of the most promising intervention methods to improve motor function in individuals with severe spinal cord injury. in parallel, an increasing number of studies is suggesting that noninvasive scs can improve spasticity and residual motor control in the same subject population. the present study explores whether single sessions of noninvasive scs would improve walking performance and ameliorate spasticity in individuals with multiple sclerosis.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis of relapsing-remitting, primary- or secondary-progressive ms * lower-limb spasticity exclusion criteria: * acute relapse of ms * other neuromuscular diseases * active and passive implants at vertebral level t9 or caudally * dermatological issues at stimulation site * pregnancy

Keywords: neuromodulation spinal cord stimulation walking function spasticity
a study of tucaresol in hiv-infected patients who are taking other anti-hiv drugs

Conditions: HIV Infections

Summary: the purpose of this study is to see if it is safe to give tucaresol to hiv-infected patients who are taking combination anti-hiv therapy (haart). this study also examines the effect tucaresol has on viral load (level of hiv in the body) when tucaresol is used with haart.

patients are enrolled sequentially into the next available dosage cohort. each cohort receives a single dose of tucaresol, is observed for 2 weeks, and then receives 3 alternate-day doses of drug and careful safety monitoring, including 4 weeks follow-up after the final dose. dose cohorts receive drug sequentially, the lowest-dose cohort receiving the drug first. dose escalation may not proceed to the next higher-dose cohort until all patients from the prior lower-dose cohort have completed the 4-week follow-up after the multiple dosing, adverse events are within the described bounds, and the fda has reviewed the safety information from the treated cohort and approved the dose escalation. the drug is administered 4 times within the 8 weeks of the study period. weekly visits are required. patients receive financial compensation.

Eligibility criteria:
inclusion criteria patients may be eligible for this study if they: * are at least 18 years old. * are hiv-positive. * have more than 300 cd4 t cells/microl at screening. * are taking certain anti-hiv drugs. * have been taking these anti-hiv drugs successfully for at least 6 months. * do not expect to change their anti-hiv therapy while they are in the study. * have had plasma viral load less than 50 copies/ml while on their anti-hiv therapy. * have viral load that cannot be detected at screening and baseline tests. * are able to complete weekly visits. exclusion criteria patients will not be eligible for this study if they: * cannot give informed consent. * have abnormal laboratory test results at baseline. * are pregnant or breast-feeding. * have had certain short-term or long-term illnesses (such as heart disease, sickle cell disease, anemia, or lung problems). * have received a vaccination within the 30 days prior to enrollment. * have received any other experimental drug within 60 days of enrollment. * are taking abacavir (ziagen, gw1592) or drugs that affect the immune system, such as il-2, gm-csf, corticosteroids, or cyclosporine. * have a history of tumors. * are actively using illegal drugs (methadone is allowed). * have hepatitis b or hepatitis c.

Keywords: hiv-1 immunity, cellular drug therapy, combination cd4-positive t-lymphocytes antigens anti-hiv agents viral load tucaresol
effect of adjunctive intracoronary streptokinase on late term left ventricular infarct size and volumes in patients with acute myocardial infarction

Conditions: Acute Coronary Syndromes; Acute Myocardial Infarction; Reperfusion Injury

Summary: the investigators hypothesized that complementary intracoronary streptokinase administration to primary percutaneous intervention in patients with acute myocardial infarction may provide limitation infarct size and improvement in left ventricular volumes and function in acute and late phases (6 months).


Eligibility criteria:
inclusion criteria: * continuous chest pain that lasted \> 30 minutes within the preceding 12 hours * st-segment elevation of at least 1 mm in 2 contiguous leads on the ecg * infarct related artery (ira) occlusion (timi grade 0) at the angiography exclusion criteria: * contraindications to streptokinase, tirofiban, aspirin, clopidogrel, or heparin * culprit lesion in saphenous vein graft * timi grade ii-iii flow in ira * additional epicardial stenosis in the ira distal to stented segment (significant or insignificant) * presence of left bundle branch block * history of prior mi

Keywords: coronary microcirculation acut myocardial infarction infarct size streptokinase reperfusion
peripheral immunologic response of solid organ transplant recipients to depletion versus non-depletion protocols

Conditions: Liver Disease; Liver Transplantation

Summary: rejection and infection are primary causes of morbidity and mortality in solid organ transplant recipients. current clinical practice relies on immunosuppressive drug levels measured in plasma to reflect the peripheral immune response in solid organ transplant recipients. direct measurement of the number and functions of the immune cells themselves using multi-parameter flow cytometry may enable individualized immunosuppression management for organ transplant recipients. multi-parameter flow cytometry will be used to compare levels and functional capabilities of multiple lymphocyte subsets between cohorts of patients receiving depletion induction and those receiving a non-depletion regimen. the activation state, cytotoxic potential and the functional capabilities of these cells will be examined within patients over the first six months post transplant.


Eligibility criteria:
inclusion criteria: * liver transplant recipient exclusion criteria: * none

Keywords: liver disease liver transplantation depletion immunosuppression non-depletion immunosuppression
optical tomography with ultrasound guidance

Conditions: Breast Cancer

Summary: the investigators propose to validate the utility of their novel hybrid imaging technique for accurate diagnosis of breast lesions, and for assessing chemotherapy response of cancer treatment and predicting treatment efficacy. the investigators' unique hybrid technique is implemented by simultaneously deploying near infrared (nir) optical sensors and a commercial ultrasound (us) transducer mounted on a hand-held probe, and utilizing co-registered lesion structure information provided by ultrasound to improve the optical tomography. as a result, the optical tomography assisted with us has overcome problems associated with intense light scattering and has provided reliable tumor angiogenesis distributions. initial results with a small group of patients who underwent biopsy have shown that early stage invasive cancers present two-fold greater total hemoglobin concentration on average than fibroadenomas and other benign lesions. initial results of advanced cancers have shown that the angiogenesis distribution is highly distorted and heterogeneous, and the distorted distributions correlate with histological microvessel density counts and can be used to assess chemotherapy response. the objective of this study is to validate the investigators' initial results that nir light guided by ultrasound can improve breast cancer diagnosis and monitor chemotherapy response.

specific objectives of the study are: objective 1: validate the sensitivity, specificity, positive predictive value and negative predictive value of optical tomography/us for distinguishing benign and early stage malignant breast tumors. approximately 300 patients who will undergo ultrasound-guided biopsy are being recruited to this study from the university of connecticut health center and hartford hospital. the total hemoglobin concentration and blood oxygen saturation will be the measured indices and the biopsy results will be used as the 'gold' standard. objective 2: perform pilot studies of optical tomography/us to assess chemotherapy response and evaluate treatment efficacy. patients diagnosed with locally advanced breast cancers (size greater than 3 cm) who will undergo chemotherapy will be enrolled to this study. approximately, 20 to 30 patients are being recruited to the study from the university of connecticut health center and hartford hospital.

Eligibility criteria:
inclusion criteria: * women undergoing ultrasound guided biopsy or breast cancer patients undergoing neoadjuvant thermotherapy treatment exclusion criteria: * women under 18 years old.

Keywords: breast cancer diagnosis optical imaging ultrasound imaging monitoring neoadjuvant chemotherapy response