Kornimate/medical-research-clean huggingface dataset:
the safety and the efficiency of hyperbaric oxygen in traumatic brain injury

Conditions: Traumatic Brain Injury

Summary: the goal of this observational study is to learn about the safety and long-term effects of hyperbaric oxygen therapy in participants over the age of 18 with traumatic brain injury (tbi). the main question it aims to answer are: does hyperbaric oxygen therapy raise independence in daily living and the ability to engage in social activities in participants with tbi when treated with hyperbaric oxygen therapy during the non-acute phrase after injury? what medical problems do participants have when treated with hyperbaric oxygen therapy? whether or not participants have used hyperbaric oxygen therapy as part of their routine medical treatment for tbi, they will answer online or telephone survey questions about their functional independence for 2 years.

the goal of this observational study is to learn about the safety and long-term effects of hyperbaric oxygen therapy in participants over the age of 18 with traumatic brain injury (tbi). this is a multicenter prospective cohort study. the main question it aims to answer are: does hyperbaric oxygen therapy raise independence in daily living and the ability to engage in social activities in participants with tbi when treated with hyperbaric oxygen therapy during the non-acute phrase after injury? what medical problems do participants have when treated with hyperbaric oxygen therapy? whether or not participants have used hyperbaric oxygen therapy as part of their routine medical treatment for tbi during non-acute phrase after injury, they will answer online or telephone survey questions about their functional independence (including cognitive functioning, physical disability, mental status, employment and social activities) for 2 years.

Eligibility criteria:
inclusion criteria: 1. age 18\~90 years old 2. patients with traumatic brain injury admitted to the rehabilitation department meet one of the following indicators: 1) clear history of exogenous trauma-causing disease (such as car accidents, heavy objects, falls, violent assaults, explosive injuries, etc.) 2) gcs score of 3 to 15 points (excluding all kinds of poisoning, sedation, shock factors) 3. clear presence of at least one of the following imaging signs on cranial ct or mri: traumatic intracranial hemorrhage, subdural hematoma, epidural hematoma, cerebral contusion, ventricular hemorrhage, subarachnoid hemorrhage, or brainstem injury; 4. good compliance, signed informed consent, and those who were judged by the investigator to be eligible for enrollment. exclusion criteria: 1. sequelae of previous spinal cord injury or combination of spinal cord injury in this injury; 2. severe coagulation disorders; 3. pregnancy status; 4. any other factors that the investigator considers to be a potential risk to the subject or that interfere with the subject.

Keywords: traumatic brain injury hyperbaric oxygen
her2 expression of ctc to predict response in her2-low advanced breast cancer patients treated with adc

Conditions: Breast Cancer

Summary: to evaluate the predictive and prognostic value of her2 expression of circulating tumor cells in her2-low advanced breast cancer patients treated with adc


Eligibility criteria:
inclusion criteria: * has pathologically documented breast cancer that: 1. is unresectable or metastatic 2. has low-her2 expression defined as ihc 2+/ish- or ihc 1+ (ish- or untested) 3. has progressed on, and would no longer benefit from, endocrine therapy 4. has been treated at least 1 prior line of chemotherapy in the metastatic setting * has protocol-defined adequate cardiac, bone marrow, renal, hepatic and blood clotting functions * receives anti-her2 adc treatment * life expectancy \> 3 months * evidence of measurable or evaluable disease (recist 1.1 criteria)in the 28 days before selection * ecog ≤2 exclusion criteria: * has breast cancer ever assessed with high-her2 expression * has previously been treated with any anti-her2 therapy, including an antibody drug conjugate * has history of (noninfectious) interstitial lung disease (ild)/pneumonitis that required steroids, has current ild/pneumonitis, or suspected ild/pneumonitis that cannot be ruled out by imaging at screening * has any medical history or condition that per protocol or in the opinion of the investigator is inappropriate for the study
paravertebral block to reduce the incidence of new onset atrial fibrillation after cardiac surgery

Conditions: New Onset Atrial Fibrillation; Anesthesia, Local; Cardiac Disease

Summary: the purpose if this pilot study is to determine if a perioperative infusion of 0.2% ropivacaine via bilateral t3 paravertebral catheters can decrease the incidence of new onset atrial fibrillation following primary cabg and/or valve surgery and compare a number of secondary outcomes.

patients in the intervention group will have ultrasound guided bilateral t3 paravertebral catheters placed prior to surgery. prior to surgery, these patients will have 5ml of 1.5% lidocaine with 1:200,000 epinephrine injected in each catheter. ropivacaine 0.2% will be administered via programmed intermittent bolus of 7ml every 60 minutes through each catheter during and after surgery. patients in the control group will receive no block and undergo surgery with routine anesthetic care guided by their cardiac anesthesiologist.

Eligibility criteria:
inclusion criteria: - participants must be undergoing one of the following elective or urgent (but not emergent) surgeries: a) primary coronary artery bypass graft (cabg) b) primary surgical aortic valve replacement (savr) c) primary surgical mitral valve replacement (smvr) d) combined cabg \& surgical valve replacement exclusion criteria: * history of atrial fibrillation or flutter * infective endocarditis * left ventricular ejection fraction (lvef) \< 30% * emergency surgery * redo surgery * contraindication to block placement including local anesthetic allergy, bleeding diathesis (physiologic or iatrogenic) * body mass index \> 35kg/m2 * pregnancy
comparison of the effects of standardized chokeberry extracts with various formulations on the levels of selected markers associated with cardiovascular disease

Conditions: Hypertension; Hypercholesterolemia

Summary: the aim of the study is to compare in a clinical condition the effect of standardized chokeberry extract in different formulations and a complex preparation containing chokeberry extract and other active ingredients in on the levels of selected markers associated with cardiovascular diseases in people with a predisposition to the development of these diseases.

randomized, double-blind, parallel study conducted under medical supervision on a group of 40 patients with known hypertension and/or hypercholesterolemia. patients receive one of the investigational products or placebo for 6 weeks. before and after the study, the following parameters are analyzed: extended lipid panel (total cholesterol (tc), triglycerides (tg), low-density lipoprotein (ldl), hdl and lipoprotein a, apolipoprotein apo a1 and apo b), levels of glucose, insulin, homocysteine, markers of kidney and liver function (alanine aminotransferase (alt), aspartate aminotransferase (ast), lactate dehydrogenase (ldh), blood urea nitrogen (bun), uric acid). effects on blood pressure and anthropometric parameters are also being evaluated.

Eligibility criteria:
inclusion criteria: * women and men, 18-55 years old * patients with known: hypertension or hypercholesterolemia, * patients on hypotensive or hypolipemic therapy for at least 6 months prior to study enrollment * signed informed consent exclusion criteria: * intake of supplements containing plant extracts, polyphenols or anthocyanins, * intake of supplements with antioxidant properties, * participation in another clinical trial, * women who are pregnant, planning to become pregnant during the study, or breastfeeding, * oncological disease, autoimmune disease, severe liver dysfunction, tuberculosis, leukemia, multiple sclerosis, aids, rheumatoid arthritis, organ transplant, * patients receiving glucocorticosteroids, anti-allergic drugs, non-steroidal anti-inflammatory drugs in exacerbations of chronic disease. * patients with signs of inflammation such as increased body temperature, redness, swelling, pain. * patients who have not given written consent to participate in the study.

Keywords: hypertension hypercholesterolemia aronia extract chokeberry extract
clinical study of the safety of a single-port endoscopic surgical system for general surgery

Conditions: General Surgery

Summary: this is a small-scale pre-clinical exploratory study to investigate the safety of a novel single-port robotic system for general surgery.

single-incision laparoscopic surgery is a surgical procedure in which multiple laparoscopic instruments are placed through a single small incision. it has the advantages of less surgical trauma, better cosmetic results and less postoperative pain compared with conventional laparoscopic surgery. however, the technical challenges and difficulties, including loss of triangulation, parallel coaxial effect, difficulty of achieving correct exposure, shared fulcrum, lack of ergonomic favorable position, etc. limited its widespread use. robot-assisted laparoscopic surgery have significant advantages such as minimally invasive, delicate, and flexible, which can greatly expand the surgeon's surgical capabilities and effectively solve the various problems faced by traditional surgery. therefore, robotic assisted single-port surgery is attracting increasing attention. this study is to investigate the safety of a novel single-port robotic system for general surgery.

Eligibility criteria:
inclusion criteria: * 18 years \< age ≤75 years * suitable for minimally invasive surgery * 18.5≤bmi≤28 kg/m2 * asa score is ⅰ-ⅲ * informed consent * colon and rectal resection: colon and rectal polyps, inflammatory bowel disease, intestinal diverticula, colorectal cancer diagnosed ct3n0m0 with a maximum diameter of ≤4 cm located above the peritoneal reflection. * partial gastrectomy: gastric stromal tumor, gastric giant ulcer. * appendectomy: chronic appendicitis. * cholecystectomy: chronic cholecystitis combined with gallbladder stones, gallbladder polyps (\> 1 cm). exclusion criteria: * with other malignancies or a previous history of other malignancies * undergone other major surgical treatment within 3 months prior to enrolment or planned during the trial * with active tuberculosis * with severe systemic disease * with long-term use of anticoagulant and anti-platelet drugs (anti-platelet aggregation drugs discontinued less than 1 week prior to surgery), history of bleeding disorders or hematopoietic or coagulation disorders. * with severe allergies and suspected or established alcohol, drug or substance addiction * patients who are immunodeficiency virus (hiv) antibody positive; hepatitis b surface antigen (hbsag) positive and have a hepatitis b virus dna (hbv-dna) copy number above the lower limit of detection or normal range; hepatitis c virus (hcv) antibody positive; syphilis spirochete antibody positive and at high risk of transmission as judged by the investigator. * emergency surgery * women who are pregnant, breastfeeding or planning to become pregnant during the trial * other conditions which, in the opinion of the investigator, make participation in this trial inappropriate.

Keywords: robotic surgery robotic assisted single-incision surgery
identifying genes that predict recurrence in women with breast cancer treated with chemotherapy

Conditions: Breast Cancer; Estrogen Receptor; Her-2; Pgr

Summary: rationale: studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in dna and identify biomarkers related to cancer. it may also help doctors predict whether cancer will come back after treatment. purpose: this laboratory study is identifying genes that may help predict recurrence in women with breast cancer treated with chemotherapy.

objectives: * assess the prognostic utility of the oncotype dx™ 21 gene profile for risk of relapse in women with node positive or high-risk node negative breast cancer. * identify individual genes whose rna expression is associated with an increased risk of relapse in these patients. * perform an exploratory analysis of individual genes whose rna expression is associated with an increased risk of relapse differentially in patients previously treated with docetaxel. outline: this is a multicenter study. tissue samples are examined for association of rna expression and clinical factors (e.g., tumor size, nodal status, hormone receptor status, age, menopause status), as well as estrogen receptor, progesterone receptor, and her-2/neu expression by immunohistochemistry and other studies. projected accrual: a total of 900 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * diagnosis of breast cancer * node positive or high-risk node negative disease * tumor \> 1.0 cm in diameter * no locally advanced, inflammatory, or metastatic breast cancer * previously treated with 4 courses of anthracycline-containing chemotherapy (i.e., doxorubicin and docetaxel or doxorubicin and cyclophosphamide) * enrolled on clinical trial ecog-e2197 * adequate tumor material available in ecog pathology coordination center * previously consented to future cancer-related research * hormone receptor status known patient characteristics: * female * menopausal status not specified prior concurrent therapy: * see disease characteristics

Keywords: estrogen receptor her-2 pgr stage ii breast cancer stage iiia breast cancer stage iiib breast cancer
silent lumbar disc herniation syndrome

Conditions: Disc Herniation

Summary: ldh is a common phenomenon that is often described in association with various pathological processes affecting the neuromuscular and locomotor systems. it is not only associated with pathology but it can also be observed in healthy individuals with no evidence of any dysfunction. since ldh is observed in such a large percentage of healthy subjects, it is probably more appropriate to perceive it as a physiological phenomenon with silent clinical biomechanical changes

an observational study will be conducted on 180 individuals without any back or lower extremity symptoms. individuals who agree to participate in the study will be divided into 3 groups based on their mri findings. group 1 (silent disc herniation group): has ldh and root compression confirmed by the mri but has no back or lower extremity symptoms. group 2 (had a history of disc herniation with an improvement of their symptoms after receiving physical therapy intervention): has ldh and root compression confirmed by the mri but has no back or lower extremity symptoms. group 3 (control group): absence of ldh and root compression confirmed by the mri has no back or lower extremity symptoms. the isokinetic peak torque for knee and ankle muscles and the h reflex will be assessed for all the individual investigating the influence of silent ldh on the isokinetic parameters and the h-reflex of the lower extremity may help in better guiding for lower extremity screening to identify individuals at risk for lower extremity injuries. it is hoped that clinicians will incorporate such information to understand the importance of confirming the improvemnt obtained from the physical therapy intervention with an mri before discharging the patients to reduce the risk of recurrence............................................................................................................................................................................................................................

Eligibility criteria:
inclusion criteria: * inclusion criteria patients with ldh and root compression with no back or lower extremity symptoms. exclusion criteria: * any previous history that would affect the alignment or the motion to lower extremity joints as fractures or surgery. any fixed deformity true leg length discrepancy (\>5mm). any medical condition affecting peripheral nerves as diabetes mellitus. any neuromuscular dysfunction and vestibular disorder.sacroiliac pain or dysfunction low back pain. radicular or referred or radiating pain previous lower extremity injury
per-operating use of a probe for detection of β+

Conditions: Neoplasms

Summary: the objective of the study is to evaluate the sensibility of the probe forimtech to detect β+ emission in vivo in humans and its usefulness during elective surgical procedure hypothesis:the probe forimtech is able to allow per-surgery detection of tumoral lesions sensible to 18f-fdg and to help in the realization of guided biopsies, minimally invasive surgery or complement of resection of tumors. the β+ emission detected by the probe forimtech is correlated to the emission γ detected by the 18f-fdg.pet/ct

patients with a malignant neoplasic lesion known or suspected for which a surgery is planned will be presented with the protocol. if inclusion/exclusion criteria are fulfilled all the procedures will be planned. a 18f-fdg pet/ct will be done. surgery will be conducted within 3 hours after the i.v. injection of 18f-fdg according to the standard procedure applied in the visceral surgery department. during the surgery, emission of β+ from the lesion (s) seen during the pet/ct will be detected with the probe. resected pieces will be analysed histologically.

Eligibility criteria:
inclusion criteria: * age \< 80 years old; * karnofsky index ≥80% ; * informed consent signed * patients with an indication of thoracic, visceral, or ent surgery with the aim of a diagnostic biopsy, of an invasive minimal treatment, or an initial or complementary resection exclusion criteria: * pregnancy * enable to sign informed consent

Keywords: f-18-fdg neoplasm probe positron diagnosis surgery radioguided surgery
the use of virtual reality during breast ultrasound-guided biopsy procedures

Conditions: Breast Neoplasm Female

Summary: to determine if a virtual reality simulation will reduce pain and anxiety in patients undergoing an ultrasound guided breast biopsy procedure.

breast biopsies for patients with abnormal mammograms are required to identify cancerous tissue. currently this procedure is done with or without a local anesthetic. patients report anxiety regarding potentially having cancer and the possibility of cancer-related procedures. different types of biopsies may have different pain and anxiety based on their duration and complexity. this research is designed to determine if vr simulated environment can reduce pain and anxiety. the aim is to study the efficacy of a virtual environment in reducing pain and procedural anxiety. it is intended for patients undergoing an ultrasound guided breast biopsy procedure that have had an abnormal mammogram. the overall aim is to discover an efficacious nonpharmacologic method to lower pain and anxiety during a standard of care procedure.

Eligibility criteria:
inclusion criteria: * informed consent is obtained from the patient * females who are 18 years of age * patient is scheduled for preoperative ultrasound guided breast biopsy procedure exclusion criteria: * patient is scheduled for a stereotactic biopsy procedure * the patient has motion sickness * the patient has severe cognitive disabilities or language barriers that inhibit study form completion in english * the patient has a history of seizures or epilepsy * refusal of patient to sign consent

Keywords: virtual reality pain anxiety ultrasound guided biopsy
efficacy of high-oleic canola and flaxseed oils for hypercholesterolemia and cardiovascular disease risk factors

Conditions: Cardiovascular Disease

Summary: the purpose of this study is to assess the efficacy of high-oleic canola oil and a high-oleic canola/flaxseed oil blend as compared to a typical western diet on plasma lipids, fatty acid profiles, and risk factors associated with cardiovascular disease in hypercholesterolemic patients. furthermore, the metabolism of dietary oleic acid and alpha-linolenic acid contained in high-oleic canola oil and flaxseed oil will be investigated.


Eligibility criteria:
inclusion criteria: * fasting serum ldl-cholesterol \>3.0 mmol/l * body mass index (bmi) between 22-36 kg/m2 exclusion criteria: * smoking * use of lipid lowering therapy * documented cardiovascular/atherosclerotic disease * inflammatory disease * diabetes * uncontrolled hypertension * kidney disease * other systemic diseases * cancer * chronic alcohol consumption (\> 2 servings/day) * excessive exercise expenditure (\> 4000 kcal/week)

Keywords: high-oleic canola oil flaxseed oil monounsaturated fatty acids polyunsaturated fatty acids alpha linolenic acid cardiovascular hypercholesterolemia lipids inflammation metabolism
effect of an inhaled corticosteroid on airway gene expression in asthma

Conditions: Asthma

Summary: the purpose of this study is to determine whether an inhaled corticosteroid (fluticasone) alters the expression of any gene expressed in the lining of the airways of asthmatics. the study uses high density gene chips which allow the study investigators to measures all gene in the human genome. we hypothesize that this approach will identify novel genes that are affected by steroids in asthmatics.

this is a 10 week, randomized, double blind, prospective study comparing the effects of inhaled fluticasone or inhaled placebo on measures of airway function, airway remodeling and airway gene expression in asthmatic subjects. enrollment has been completed as have all study visits. we are now in the data analysis phase. the study design was as follows: following a one-week run-in/characterization period, subjects were randomized to receive 2 puffs bid of fluticasone (250µg/puff) or matching placebo for 8 weeks. beginning with the run-in period, subjects recordes in a daily diary their peak flow measurements twice daily, (symptoms of cough, sputum production, wheeze, dyspnea, and chest tightness. they visited the laboratory for an interval diary review and spirometry and for medication dispensing. bronchoscopy was performed at baseline (week 1 of the run-in), and 1 week after starting the study drug weekly telephone contact will be made during the treatment period to monitor subject well being and to ensure compliance with study medication. there was a one-week run-out to allow monitoring of subjects after discontinuation of the study drug.

Eligibility criteria:
inclusion criteria: * male and female patients with a history of asthma between the ages of 18 and 70 years. * pc20fev1 methacholine ≤ 8.0 mg/ml. * at least one of the following symptoms, beta agonist use, or fev1 criteria: * asthma symptoms on at least two days per week or beta agonist use on at least two days per week or fev1 \< 85% predicted * subjects must be non-smokers (patients who have never smoked or patients who have not smoked for 1 year and have a total pack-year smoking history \< 15 packs). exclusion criteria: * history of oral or inhaled steroid use in the past 4 weeks. * fev1 \< 60% predicted. * lung disease other than asthma. * patients with a history of a respiratory tract infection in the 4 weeks preceding the study. * patients who have experienced a significant exacerbation in their asthma in the 6 weeks prior to the study. * patients receiving hyposensitization therapy with the exception of those who are on a stable dose for the last three months. * patients with cardiovascular disease (active) peptic ulcer disease or diabetes mellitus. * females who are lactating or who are pregnant.

Keywords: asthma corticosteroid gene expression