Kornimate/medical-research-clean huggingface dataset:
evaluation of the archimedes™ system for transparenchymal nodule access

Conditions: Lung Cancer

Summary: the archimedes system is an image-guided navigation system used to access tissue samples in the lungs. this study is being conducted to confirm the performance of the archimedes system in patients who are scheduled for standard bronchoscopy to diagnose highly suspicious lung cancer or metastatic disease. navigation to and sampling of the patient's lung cancer tumor is conducted.


Eligibility criteria:
inclusion criteria: 1. age 21-75 years at screening 2. highly suspicious spn, defined as distinct nodule with a diameter of ≥8mm in its largest dimension 3. no known endobronchial tumor 4. tumor located anywhere in parenchymal tissue \>1 cm from pleura and accessible bronchoscopically through a poe. 5. willing to participate in all aspects of study protocol for duration of study 6. able to understand study requirements 7. signs study-related informed consent document exclusion criteria: 1. any contraindication to bronchoscopy, for example: * untreatable life-threatening arrhythmias * inability to adequately oxygenate the patient during the procedure * acute respiratory failure with hypercapnia (unless the patient is intubated and ventilated) * recent myocardial infarction * previously diagnosed high-grade tracheal obstruction * uncorrectable coagulopathy 2. known coagulopathy 3. platelet dysfunction or platelet count \< 100 x 103 cells/mm3 4. history of major bleeding with bronchoscopy 5. suspected pulmonary hypertension: additional testing required, such as echocardiogram 6. moderate-to-severe pulmonary fibrosis 7. severe emphysema or copd: additional testing and pi consent is required 8. bullae \>5 cm located in vicinity of target spn 9. any other severe or life-threatening comorbidity that could increase the risk of bronchoscopic biopsy or atv tunneling, for example: * asa class \> 3 * \> stage 3 heart failure * severe cachexia * severe respiratory insufficiency or hypoxia 10. ongoing systemic infection 11. contraindication to general anesthesia 12. inability to stop anticoagulants (e.g., heparin, warfarin) or antiplatelet agents (e.g. aspirin, clopidogrel) prior to procedure 13. participation in any other study in last 30 days 14. prior thoracic surgery on the same side of the lung as the spn. 15. breastfeeding women or females of childbearing potential with a positive pregnancy test prior to the procedure or the intent to become pregnant during the study. 16. life expectancy of less than one year. 17. scheduled for lung surgery within 72hrs post-scheduled diagnostic bronchoscopy 18. pregnancy
cognitive impairment following sedation for colonoscopy with propofol, midazolam and fentanyl combinations

Conditions: Cognitive Impairment

Summary: our hypothesis is that adding midazolam and/or fentanyl to propofol sedation for elective outpatient colonoscopy increases cognitive impairment at hospital discharge without improving intraoperative conditions or reducing intraoperative side-effects. 200 healthy patients aged 18 years or older will be randomised to receive propofol or propofol plus midazolam and/or fentanyl. cognitive impairment will be tested at hospital discharge using cogstate computerised testing software.

a great variety of drug combinations are administered to patients having elective outpatient colonoscopy. in addition, as patients are going home, some may have residual cognitive deficits that making leaving the hospital unsafe. this study aims to find drugs combinations that are associated with the least cognitive impairment.

Eligibility criteria:
inclusion criteria: * aged 18 years or older presenting for elective outpatient colonoscopy following full bowel preparation exclusion criteria: * no cognitive impairment * adequate english language comprehension * not combined with other procedures
evaluating the use of thromboelastography (teg) in patient's requiring extracorporeal membrane oxygenation (ecmo)

Conditions: Heart Disease; Lung Disease

Summary: this is a pilot study that seeks to evaluate the feasibility and safety of using a teg algorithm in addition to traditional laboratory tests to guide transfusion and coagulation management of ecmo patients.

all adult patients requiring ecmo will be considered for the trial, with a target enrollment of 50 participants over a two-year period. for each enrolled participant, a teg transfusion algorithm will be followed for patients exhibiting inadequate hemostasis in the operating room (flowchart 1). once patient has a normal teg result with adequate hemostasis, either heparin or bivalirudin will be used as the anticoagulant. if patients are receiving no anticoagulation or heparin anticoagulation then a second teg algorithm will be followed in the icu when hemostasis is normal and heparin is introduced (flowchart 2). if patients are receiving bivalirudin as their anticoagulation strategy, the transfusion parameters with teg application will not apply. in addition to determining the compliance and feasibility of following these teg algorithms, clinical outcome data including transfusion rates, types of blood products transfused, estimated blood loss and thrombotic events will be collected for every enrolled patient until they are discontinued from ecmo. statistical analysis of the primary, secondary and tertiary endpoints of this study will determine the likelihood of exploring future clinical trials involving teg-driven coagulation and transfusion management of the ecmo population.

Eligibility criteria:
inclusion criteria: * patient's requiring ecmo placement exclusion criteria: * other than children less than 18 years of age, no one will be excluded.

Keywords: ecmo teg
treatment of cervical syndrome with myofascial therapies

Conditions: Cervical Syndrome

Summary: this study aimed to investigate the effects of myofascial release therapy (mrt) for improving pressure pain thresholds (ppts), range of motion and pain in patients with mechanical neck pain (np).

fifty-four participants with np were randomly allocated to either an mrt (five sessions) or a physical therapy (pt) groups (ten sessions) during two weeks. multimodal pt program included: ultrasound therapy (us), transcutaneous electric nerve stimulation (tens) and massage. visual analogue scale (vas), range of motion and (crom) ppts in sub-occipital and upper trapezius muscles were measured at baseline, at the end of treatment and at 1 month follow-up. t-tests and a repeated-measures multivariate analysis of variance (rm-manova) were used for vas, crom and ppts, respectively.

Eligibility criteria:
inclusion criteria: * patients of both sexes, aged between 20 and 60 years, in an active state of pain and diagnosed with muscle breakdown exclusion criteria: - patients who are pregnant, have pacemakers and surgically operated in the area to be treated

Keywords: neck pain physical therapy modalities fascia manual therapy massage
effect of patient priorities care implementation in older veterans with multiple chronic conditions

Conditions: Multiple Chronic Conditions; Decision Making, Shared

Summary: the investigators will conduct a randomized control trial enrolling 366 older veterans with multiple chronic conditions receiving primary care at the michael e. debakey va medical center and va connecticut medical center to determine if patient priorities care reduces treatment burden, increases priorities-aligned home and community services, and sets shared health outcome goals compared with usual care. the investigators will randomize at the patient level rather than clinic or clinician level to evaluate the effect of identifying patient priorities on clinician decision making and alignment of care with identified priorities.


Eligibility criteria:
inclusion criteria: * 2 encounters in prior 18 months * 3 active health problems on active problem list or prescribed 10 medications exclusion criteria: * nursing home resident * end stage renal disease on dialysis * active serious mental illness (psychosis, schizophrenia, etc) * active substance use disorder * complete hearing loss * dementia * non-english speaker (translator required) * 4 or more no-show appointments in the last 6 months * the investigators will present a list of eligible patients to pcps prior to chart review to identify patients who the pcp: * a) believes cannot participate independently or provide informed consent due to cognitive impairment * b) "would not be surprised if the patient passed away within the next 12 months?"

Keywords: patient centered care geriatrics
behavioral medicine intervention with depressed patients in a community health center setting

Conditions: Depression

Summary: the linkage between the massachusetts general hospital (mgh)-community health associates and the mgh-benson henry institute for mind-body medicine began in order to address the concern of providing affordable, easily accessible, culturally appropriate behavioral medicine interventions for low income patients served by mgh community health centers, as well as the desire to demonstrate the efficacy and economics of these interventions. since depression was such a prevalent issue among health center patients, with a significant impact on health care service utilization, it was decided to focus on offering mind/body services to this population first.

the application of behavioral medicine programs in community health settings is important to explore, as that application empowers the patient to apply self-care modalities that can be utilized in the long-term, for depression as well as for many other stress-related illnesses. behavioral and mind/body techniques, such as the relaxation response, have been reported to be useful therapeutically (often as an adjunct to medical treatment) in numerous conditions that are caused or exacerbated by stress including: mild to moderate depression/anxiety; anxiety; headache; back/neck pain; myocardial ischemia; premature ventricular contractions in stable ischemic heart disease or hypertension; osteoarthritis; stress symptoms; improved outcomes after cardiac and other surgery; pain relief and anxiety reduction in femoral arteriography and other invasive medical procedures; premenstrual syndrome; infertility; psychosomatic complaints; chronic pain; insomnia; musculoskeletal disorders; wound healing; rheumatoid arthritis; fibromyalgia and disease and treatment related symptoms of cancer. in our recent review of the literature, we suggest that the relaxation response may be an appropriate and relevant therapeutic state to counteract several stress-related disease processes.

Eligibility criteria:
inclusion criteria: * patients 21 years of age or older * diagnosis of depression * currently being treated for depression with medications and/or psychological counseling through one of the mgh-healthcare centers. * planning to continue using the health center as their main source of general medical services for the coming year. exclusion criteria: * history of bipolar disorder * active substance abuse * history of psychosis * severe cognitive dysfunction (mmse ≤ 24) * inability to speak english * we will not exclude patients on the basis of their religious preferences or practices.
l-prf in cranial surgery

Conditions: Cranial Sutures; Closure

Summary: the investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of l-prf is non-inferior to classical fibrin sealants.

the investigators want to demonstrate in a prospective, randomized trial including 350 patients undergoing cranial surgery that the use of l-prf is non-inferior to classical fibrin sealants. approximately 350 patients undergoing cranial surgery will be enrolled in this randomized, controlled, single-blinded monocenter study to evaluate the safety and effectiveness of autologous blood-derived products (l-prf and fibrinogen) compared to the fibrin sealants as an adjunct for dural repair (= primary objective). the investigators will also evaluate if the use of l-prf obviates the need for the use of other autologous grafts (e.g. muscle/fat), commercial collagen-based products (e.g. tachosil) or articifial dura (=secondary objective).

Eligibility criteria:
inclusion criteria: * patients undergoing cranial neurosurgery whereby the dura is intentionally opened (supratentorial and infratentorial approach) * age ≥ 18 years * written informed consent * willing to comply with the study schedule exclusion criteria: * participation in another clinical trial with study drugs or devices * pregnancy

Keywords: l-prf csf leakage fibrin sealants
goal directed therapy (gdt) in cytoreductive surgery (crs) and hyperthermic intra peritoneal chemotherapy (hipec)

Conditions: Primary Peritoneal Neoplasm; Secondary Peritoneal Neoplasm

Summary: the aim of the study is to assess whether in cytoreductive surgery (crs) and hyperthermic intraperitoneal chemotherapy (hipec) the use of a protocol of intravenous fluid therapy combined with goal directed fluid therapy (gdt) is associated with a significant change in morbidity, length of hospital stay and mortality compared to a standard fluid therapy. patients undergoing crs and hipec are randomly divided into two treatment groups. the gdt group receive fluid intravenous therapy according to a specific treatment protocol guided by monitored hemodynamic parameters assessed using the arterial pressure signal monitoring to assess stroke volume and cardiac output via an automated pulse contour analysis (flotrac/vigileo®); the control group receive the standard fluid therapy (crystalloid and colloid). fluid therapy regimen is free in the control group and targeted in the gdt group. in both groups, the investigators evaluate the incidence of major abdominal and systemic complications, the total duration of hospital stay, mortality, the total amount of fluids administered, their breakdown (crystalloid/colloid) and the total number of colloid boluses administered.


Eligibility criteria:
inclusion criteria: * patients selected for cytoreductive surgery and hyperthermic intraperitoneal chemotherapy exclusion criteria: * patients under the age of 18, patients with hemodynamically significant aortic regurgitation and heart rhythm disorders

Keywords: cytoreductive surgery hyperthermic intraperitoneal chemotherapy goal directed fluid therapy
diagnostic accuracy of quantitative neuropad test for diabetic peripheral neuropathy

Conditions: Diabetic Peripheral Neuropathy

Summary: this study aimed to evaluate the diagnostic vaule of quantitative neuropad for diabetic peripheral neuropathy

this is a diagnostic study. every patient will undertake neuropad test, inculding the visual and quantitative screening tests. the visual screening test includes whether the neuropad test paper changes completely from blue to pink within 10 minutes (visual screening test a) and the time to complete color change (visual screening test b). the quantitative screening test using a handheld color scanner to scan the rate of color change, which estimated by the slope of the neuropad color change per minute. the visual and quantitative screening tests were compared when the neuropathy disability score (nds) and the neurological symptom score (nss) combined score as diagnostic criteria.

Eligibility criteria:
inclusion criteria: 1) diagnosed type 2 diabetic patients; 2) age between 18 and 80 years. exclusion criteria: 1) patients with type 1 diabetes, secondary diabetes, and patients with pre-existing diabetic foot; 2) exclusion of the following clinical conditions: foot skin lesions (scarring, rash, flaking skin, infection, etc. on the skin of the test site), peripheral arterial occlusive disease, long-term heavy smoking, chronic alcohol abuse, thyroid disease, liver insufficiency (more than 3-fold increase in liver enzymes), renal insufficiency (egfr ≤ 30 ml /min/1.73m2), acute and chronic infections, cervical and lumbar spine diseases, bone and joint system diseases, other neurological diseases, autoimmune diseases, malignant tumors, psychiatric or psychological diseases, taking drugs that affect autonomic function, and combined with other diseases that can cause peripheral neuropathy; 3) those who cannot complete the experiment as required.
combination of auy922 with trastuzumab in her2+ advanced breast cancer patients previously treated with trastuzumab

Conditions: Advanced HER2-positive Breast Cancer

Summary: the phase ib part of the trial will assess the mtd of auy922 in combination with trastuzumab in patients with trastuzumab-refractory locally advanced or metastatic her2+. the mtd is defined as the highest drug dosage not causing in the first cycle of treatment (28 days) medically unacceptable dose limiting toxicity (dlt). the phase ii part of the trial will assess any potential effect on efficacy of adding auy922 to trastuzumab in patients with trastuzumab-refractory locally advanced or metastatic her2+ breast cancer. both auy922 and trastuzumab will be administered as a weekly iv infusion. treatment should be continued as long as the patient does not have disease progression and tolerates the treatment. the following reasons are examples of acceptable reasons for discontinuing the study; tumor progression (by recist, as assessed by the investigator), unacceptable toxicity, death, or discontinuation from the study for any other reason, such as patient refusal, withdrawn consent, lost to follow-up or investigator decision.


Eligibility criteria:
inclusion criteria: * female patients with confirmed her-2 positive , non-operable locally advanced or metastatic breast cancer * all patients must have received at least 1 but no more than 2 prior anti her2 based regimens including at least 1 regimen containing trastuzumab. * all patients must have at least one measurable lesion as defined by recist criteria. * all patients must have documented progressive disease following the last line of therapy before entering the study * ecog performance status ≤ 1 exclusion criteria: * patients with known cns metastasis which are: symptomatic or require treatment for symptom control and/or growing * prior treatment with any hsp90 or hdac inhibitor * impaired cardiac function * acute or chronic liver or renal disease * patients who are currently receiving treatment with any medication which has a relative risk of prolonging the qtc interval or inducing torsades de pointes and cannot be switched or discontinued to an alternative drug prior to commencing auy922 * patients with a history of another primary malignancy that is currently clinically significant or currently requires active intervention * patients who do not have either an archival tumor sample available or are unwilling to have a fresh tumor sample collected at baseline. other protocol-defined inclusion/exclusion criteria may apply

Keywords: trastuzumab-refractory advanced her2-positive breast cancer, hsp90, 2nd or 3rd line treatment
platelet rich fibrin in the treatment of multiple gingival recessions

Conditions: Gingival Recession

Summary: the aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (prf) and connective tissue grafts in the treatment of multiple gingival recessions.

the aim of this randomized controlled clinical study is to evaluate and compare the effectiveness of platelet rich fibrin (prf) and connective tissue grafts in the treatment of multiple gingival recessions. primary outcome variables were percentage of complete root coverage and mean root coverage percentages at 6 months follow up. the secondary outcome variables include keratinized tissue and gingival thickness gain. sample size has been estimated as 13 in each treatment arm. all recessions are treated with modified coronally advanced flap. on test sites prf membrane and on control sites connective tissue grafts will be placed under modified coronally advanced flaps. random allocation of the treatment sites to test and control groups were performed using a computer software designed for randomization. clinical parameters such as gingival index, plaque index, keratinized tissue width, gingival recession depth and width were measured at 1, 3 and 6 months. probing pocket depth, clinical attachment level, gingival thickness and gingival recession area were measure at baseline and 6 months. all gingival recession-related parameters such as recession height, recession width and recession area and keratinized tissue width along with mean root coverage and complete root coverage were assessed on standardized clinical photographs using an image analysis software. clinical photographs were obtained at baseline and 1, 3 and 6 months after surgical intervention. 4 mm length wire was placed on gingiva to check reproducibility and to obtain standardized pictures. gingival tissue thickness were measured with an #15 endodontic reamer attached to rubber stopper inserted perpendicularly into the gingival tissue 2 mm below the gingival margin; thickness of the reamer will be measured with a digital caliper. mean root coverage percentage was calculated as percentage of covered root surface area at 6 months. follow up of subjects was 6 months.

Eligibility criteria:
inclusion criteria: * two or more adjacent teeth with at least 2 mm miller class i gingival recessions at non-molar teeth * identifiable cej on all teeth * age ≥ 18 * presence of tooth vitality and absence of restorations and superficial caries in the treatment area * no past surgical treatment history of affected area. * gingival thickness ≥ 0,8 mm for recession areas. * sufficient palatal donor tissue for connective tissue harvesting. exclusion criteria: * smoking * pregnancy or lactation * systematic diseases that may affect outcomes of periodontal therapy * self-reported antibiotic medication within three months * occlusal trauma in treatment site

Keywords: multiple gingival recession platelet rich fibrin connective tissue graft microsurgery periodontal diseases gingival recession
pegfilgrastim as support to pediatric sarcoma patients receiving chemotherapy

Conditions: Sarcoma; Neutropenia

Summary: physicians are conducting a clinical trial for patients with pediatric sarcoma. sarcoma is a type of bone cancer that can be treated with chemotherapy which can affect the bone marrow, where blood cells are produced. neutrophils are a type of white blood cells that fight infection and are produced in the bone marrow. if the neutrophil count becomes too low due to chemotherapy, a potentially serious condition called neutropenia occurs. neutropenia is serious because it can affect the body's ability to protect against many types of infections. pegfilgrastim is an investigational drug being evaluated for its potential ability to increase the number of neutrophils. the purpose of this study is to determine the safety and effectiveness of pegfilgrastim in preventing neutropenia following chemotherapy in pediatric patients up through the age of 21 with sarcoma.


Eligibility criteria:
* sarcoma \* no previous chemotherapy or radiotherapy \* patients who will be receiving chemotherapy consisting of vincristine, doxorubicin, cyclophosphamide, etoposide, ifosfamide, and mesna

Keywords: bone cancer sarcoma neutropenia chemotherapy