Kornimate/medical-research-clean huggingface dataset:
monitoring of the bone free flaps with microdialysis

Conditions: Flap Necrosis

Summary: microdialysis is admitted to be reliable by numerous surgeons to monitor flaps. nevertheless, a few authors reported follow up with microdialysis in bone free flaps, and they all describe the position of the catheter in the surrounding soft tissue muscle which is not the accurate reflect of bone vascularisation. the aim of this study is to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.

failure rate of facial reconstructive surgery with bone free flaps varies between 11 and 25%. in case of buried bone free flaps, the follow up is even more difficult. monitoring methods, such as the implantable doppler system, laser doppler flowmetry and microdialysis have been developped in the last 15 years. ferguson et al. show a false positive rate of 31% with implantable doppler monitoring of buried flaps. the purpose of this study is to to determine the lactate/pyruvate ratio mean value in bone free flaps with a microdialysis catheter directly positioned in the bone tissue.

Eligibility criteria:
inclusion criteria: * adult person * signed informed consent * head and neck reconstruction with iliac crest or fibula free flap * patient covered by national health insurance exclusion criteria: * minor person * head and neck reconstruction with other types of free flaps than crest or fibula free flap * pregnant or breastfeeding women

Keywords: microdialysis bone free flap fibula iliac crest
online multi-component psychological intervention for depression, anxiety and well-being in 7 countries

Conditions: Anxiety; Depression; Wellbeing; Stress

Summary: this study evaluates the effectiveness of an online multi-component psychological intervention, that is focused on providing self-support to the population of 5 latin american countries and 2 european countries. the objectives of the intervention are: 1) to reduce the symptoms of anxiety and depression in the adult population, 2) to increase the levels of subjective well-being.

anxiety and depression at clinically significant levels are associated with suicidal thoughts and behaviors. furthermore, it is associated with the health-disease process in two ways: 1) variables that influence behavior, hindering people's healthy habits and promoting the development of unhealthy behaviors; 2) anxiety and depression affect the psycho physiological activation of people, which affects their immune system. considering the damage that can occur by not addressing incipient problems of anxiety and depression, it is important to develop interventions with preventive purposes. thus, the online modality of the intervention presented in this project can benefit a significant number of people in mexico, ecuador, chile, brazil, peru, the netherlands and spain. the online modality of psychological interventions is a viable treatment alternative, especially for those people who do not have any psychological treatment within their reach. the participants will be measured at pre, middle treatment, post assessment and two follow ups of 3 and 6 months. the self-report measures will include the following psychometrics: 1. general anxiety disorder with 7-items (gad-7) 2. center for epidemiologic studies depression scale" in its revised version (cesd-r). 3. perceived stress scale (pss-10) 4. pittsburgh sleep quality scale (psqi) 5. action acceptance questionnaire ii (aaq-ii) 6. the satisfaction with life scale 7. the warwick-edinburgh mental well-being scale (wemwbs) 8. perceived deficits questionnaire (pdq-5) 9. the positive and negative affect schedule (panas) 10. opinion on the treatment. 11. system usability scale. 12. client satisfaction questionnaire (csq-8s) 13. the telehealth usability questionnaire (tuq)

Eligibility criteria:
inclusion criteria: * age 18 years or older * completion of 100% of the basal evaluation through the form * residence in one of the countries participating in the study * fluency/ proficiency in spanish (mexico, ecuador, chile, peru and spain), dutch or english (netherlands) or portuguese (brazil), depending on the country. exclusion criteria: * participants with severe symptoms of anxiety and/or depression, or they report a diagnosis of a depression and/or an anxiety disorder. * participants who self-report having another diagnosed psychiatric comorbidity: personality disorder, psychotic disorder, bipolar disorder, attention-deficit/hyperactivity disorder, or others. * participants taking medication for symptoms of depression and/or anxiety
cladribine plus pegylated interpheron alfa-2a in systemic mastocytosis

Conditions: Systemic Mastocytosis

Summary: the aim of this study is to evaluate the efficacy in terms of clinical and biological response rates of cladribine plus pegylated interpheron alpha-2a therapy in patients with advanced systemic mastocytosis carrying d816v or other exon 17 kit mutations.


Eligibility criteria:
inclusion criteria: * age older than 18 years. * diagnosis of advanced systemic mastocytosis (aggressive systemic mastocytosis or proggressing systemic mastocytosis) with d816v or other exon 17 kit mutations. * ecog ≤ 3. * signed informed consent. exclusion criteria: * impaired liver function (total bilirubin ≥ 2.0 mg/dl, ast or alt \> 3 x upper limit of normal)not related to mastocytosis. * impaired renal function (≥ 2.0 mg/dl)not related to mastocytosis. * grade iii-iv cytopenias not related to mastocytosis. severe cardiopathy (grade iii/iv of nyha, or left ventricular ejection fraction \< 50%). * pregnancy or breastfeeding. * female patients who do not use contraceptive methods.

Keywords: mast cell mastocytosis mast cell disease
a study on the safety and tolerability of rovalpituzumab tesirine in japanese patients with advanced, recurrent small cell lung cancer

Conditions: Small Cell Lung Cancer

Summary: this is a japanese, multicenter, open-label, dose-escalation study. this is the first study to assess the safety and tolerability as well as explore the pharmacokinetics, pharmacodynamics and antitumor activity of rovalpituzumab tesirine in japanese participants with advanced small cell lung cancer (sclc).


Eligibility criteria:
inclusion criteria: * histologically or cytologically confirmed advanced, recurrent small-cell lung cancer (sclc) with documented disease progression after at least two (2) prior systemic regimens, including at least one (1) platinum-based regimen. * eastern cooperative oncology group (ecog) performance status of 0 or 1. * adequate hematologic, hepatic and renal function. exclusion criteria: * no prior exposure to a pyrrolobenzodiazepine (pbd)-based drug.

Keywords: advanced, recurrent small cell lung cancer small cell lung cancer rovalpituzumab tesirine cancer
ocular manifestations of inflammatory bowel disease

Conditions: Inflammatory Bowel Diseases; Ophthalmopathy

Summary: ocular damage is found in the 3rd rank of extra intestinal manifestations (mei) potentially serious functional complications (see uveitis and risk of blindness) requiring rapid management rare uveitis in the literature (0.5% -3%), study on a large sample to assess their prevalence in patients with ibd at the nancy chru and describe all the ocular manifestations that can be found.


Eligibility criteria:
inclusion criteria: * adult patients followed at nancy university hospital for ibd and having consulted in the ophthalmology department exclusion criteria: * minor patients * patients without ibd * patients for whom there is no ophthalmology consultation
a multicentre phase i-ii study to investigate the combination of bendamustine with weekly paclitaxel as first or second line therapy in patients with metastatic breast cancer

Conditions: Metastatic Breast Cancer

Summary: the aim of the study is to establish a feasible combination of bendamustine and paclitaxel in a weekly schedule. the two agents have different toxicity profiles and are well tolerated when given in a weekly fashion. the combination might be of special interest for elderly patients with hormone insensitive breast cancer


Eligibility criteria:
inclusion criteria: * written informed consent must be obtained and documented according to the local regulatory requirements prior to beginning specific protocol procedures; * pathological confirmed primary carcinoma of the breast. * locally advanced or metastatic disease * up to one previous palliative chemotherapy that did not contain docetaxel or paclitaxel. previous adjuvant treatment with taxanes is allowed when the last application of the taxane was given at least 1 year before entering the trial. * patients must have either measurable or non-measurable lesions according to the who criteria * at least 4 weeks since radiotherapy, with full recovery. the measurable disease must be completely outside the radiated field or there must be pathological proof of progressive disease. * complete radiological and clinical tumor assessment within 4 weeks prior to registration performed as clinically indicated * karnofsky-index ≥ 60 % * age ≥ 18 years * absolute neutrophil count ≥ 1,500 cells/µl, platelets ≥ 100,000/µl, and hemoglobin ≥ 9 g/dl * bilirubin within normal limits; evaluation of transaminases and alkaline phosphatase ≤ 5x upper normal limit * serum creatinine ≤ 2.0 mg/dl * normal left ventricular ejection fraction (lvef) by echocardiogramme * patients of childbearing potential, pregnancy test must be negative * if fertile effective contraception must be used throughout the study exclusion criteria: * known or suspected hypersensitivity reaction to the investigational compounds or incorporated substances; * concurrent immunotherapy or hormonal treatment for cancer (bisphosphonates may be continued) * symptomatic parenchymal brain metastases not responding to treatment * life expectancy less than 3 months * other serious illness or medical condition that may interfere with the understanding and giving of informed consent and the conduct of the study * concurrent treatment with other experimental drugs or any other anti-cancer therapy within the last 28 days; * history of congestive heart failure or other significant uncontrolled cardiac disease * pregnant or nursing women

Keywords: palliative breast cancer metastatic bendamustine phase i
treatment of tinnitus with migraine medications

Conditions: Tinnitus, Subjective; Tinnitus

Summary: tinnitus represents one of the most common and distressing otologic problems, and it causes various somatic and psychological disorders that interfere with the quality of life. it is well-understood that many factors, such as poor education, lower income, or occupational, and recreational activity associated with high noise exposure, influences the prevalence and risk of tinnitus. although the economic and emotional impact of tinnitus is large, there is currently no fda-approved medication to treat this condition. however, there are pharmacological options to address the stress, anxiety, and depression that are caused by tinnitus. in this project, we intend to use medications for patients with tinnitus in order to decrease the impact of tinnitus on their daily life and activities.

this study is 8 weeks in duration. there are three arms in the experiment: the first is nortriptyline (7.5 mg) plus topiramate (10 mg), the second is verapamil (30 mg) plus paroxetine (4 mg), and the third is a placebo group. this is a double-blinded trial. participants will be randomized to one arm for the duration of the trial using simple randomization with a computer-generated number. both medication combinations and placebo may include dosage increases weekly if symptoms do not improve. nortriptyline may be increased by 7.5mg weekly (to a maximum of 60mg), topiramate by 10mg weekly (maximum 80mg), verapamil by 30mg weekly (maximum 240mg), and paroxetine by 4mg weekly (maximum 32mg). symptomatic survey scores from each arm will be obtained before and after treatment and weekly. an unblinded neurotologist attending (dr. harrison lin) will also become involved with patients' treatments as they start to report changes in symptoms in order to monitor their safety and provide advice on change in dosage if patients have questions.

Eligibility criteria:
inclusion criteria: * patients with moderate to severe tinnitus. * male or female between the ages of 25 to 85 years. * subject must be compliant with the medication and attend study visits. * must be able to read and write in the english language to provide consenting. exclusion criteria: * pregnancy will result in automatic exclusion from the study. rule out of pregnancy will be done by a urine pregnancy test to confirm the situation for all women who are of child bearing potential. * subject with history of an adverse reaction to medication being prescribed. * subject suffers from a medical condition or has history that may be concerning to the investigators clinical opinion. * all contraindications for the medications which prevent subjects from randomization will be considered as exclusion criteria.

Keywords: tinnitus medication randomized rct trial migraine
cognitive-behavioral (cbt) in esrd patients with depression

Conditions: Kidney Failure, Chronic; Depression; Quality of Life

Summary: depression is common in end-stage renal disease (esrd) patients and has a negative effect on the quality of life, functional ability, and mortality, with a prevalence rate as high as 20-25%. however, it is hard to use anti-depressant due to the safety issue, and there has been little data so far particularly in terms of randomized clinical trials. here, we investigate the effect of cognitive-behavioral group therapy for enhancing mental health and quality of life in patients with esrd.


Eligibility criteria:
inclusion criteria: * patients with end-stage renal disease : on hemodialysis more than 3 months * patients with bdi-ii score \>= 15 points * adult with age \>= 20 years old * patients who were able to understand and willing to sign the written informed consent exclusion criteria: * patients on hemodialysis due to acute kidney injury * patients who are on admission * patients who are undergoing chemotherapy or radiation therapy due to progressive malignant disease * patients who are planning kidney transplantation within few months * patients with cognitive dysfunction, mental retardation, and drug addict * patients who are unavailable for adequate communication with researchers * patients who changed anti-depressive agent or dose within 2 months before/after the trial
chemoembolisation with cpt11 loaded dc bead with cetuximab and 5fu/lv in first line in patients with kras wildtype mcrc

Conditions: Liver Metastases; Colorectal Cancer

Summary: the purpose of this study is to assess feasibility of chemoembolization with dc bead loaded with irinotecan in combination with cetuximab and 5fu/lv as a first line treatment for wildtype kras unresectable liver metastases from colorectal cancer.

20 patients will be included. the duration of the trial will be approximately 24 months. every 8 weeks there will be a tumour lesion assessment.

Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of stage iv kras wild-type colorectal adenocarcinoma, with metastases predominantly in the liver (≥80% of tumor burden) that are deemed unresectable. 2. primary tumour has been treated with complete surgical resection without evidence of residual tumour 3. patients must have at least 1 measurable lesion (recist criteria) 4. performance status ecog 0-1 5. aged ≥18 years 6. life expectancy \> 3 months 7. no prior chemotherapy for metastatic disease 8. hematologic function: wbc ≥ 3.0 x 10\*9/l, platelets ≥ 100 x10\*9/l 9. adequate organ function as measured by: * serum creatinine £ 1.5 x upper limit of normal (uln) * serum transaminases (ast \& alt) £ 5 x uln * bilirubin\> 1.5 times the upper limit of the normal range 10. women of child bearing potential and fertile men are required to use effective contraception (negative βhcg for women of child-bearing age) 11. signed, written informed consent 12. patients with patent main portal vein 13. maximum liver involvement ≤60% exclusion criteria: 1. presence of cns metastases 2. contraindications to fu/lv, irinotecan or cetuximab 3. active bacterial, viral or fungal infection within 72 hours of study entry 4. women who are pregnant or breast feeding 5. allergy to contrast media or history of severe hypersensitivity to study drugs. 6. presence of another concurrent malignancy. prior malignancy in the last 5 years except adequately treated basal or squamous cell skin cancer or carcinoma in situ of the cervix 7. any contraindication for hepatic embolization procedures: * porto-systemic shunt * hepatofugal blood flow * severe atheromatosis 8. contraindication to hepatic artery catheterization, such as a patient with severe peripheral vascular disease precluding catheterization 9. other significant medical or surgical condition, or any medication or treatment regimens, that would place the patient at undue risk, that would preclude the safe use of chemoembolization or would interfere with study participation

Keywords: chemoembolization dc bead™ irinotecan cetuximab 5fu/lv kras metastatic colorectal cancer
managing kyphosis with exercise

Conditions: Kyphosis

Summary: the primary objective of this study is to determine if stretching exercises as a conservative treatment option will correct kyphosis in postural and scheuermann's kyphosis.

despite comprehensive documentation of surgical interventions in existing literature, the investigation into non-operative approaches for addressing hyperkyphosis or scheuermann's kyphosis in the pediatric population has been investigated with inconsistent findings. various outcomes have been observed with regard to the effectiveness of multiple brace treatment options, alongside recommendations for various physiotherapeutic approaches, either in conjunction with brace treatment or as standalone interventions. however, there is no universally accepted consensus regarding the conservative management of kyphosis that simultaneously ensures substantial patient satisfaction and heightened bodily awareness. notably, there have been no studies investigating the efficacy of stretching in the treatment of individuals with kyphosis.

Eligibility criteria:
inclusion criteria: * patients ages 8 and older with postural or scheuermann's kyphosis with \>45° of kyphosis or \>10° of thoracolumbar kyphosis from t11-l1 or other cases which seem to have excessive kyphosis. * parents of patients aged 17 and younger who are 18 and older and cognitively able to complete a survey will be included in the study as well. exclusion criteria: * patients with congenital kyphosis or scoliosis greater than 30°. * parents of patients aged 17 and younger who are less than 18 years of age or cognitively unable to complete a survey will be excluded from the study. * any records flagged "break the glass" or "research opt out."

Keywords: scheuermann's thoracolumbar postural stretching back
therapeutic ultrasound on renal function

Conditions: Ultrasound Therapy; Complications; Low Back Pain

Summary: this study evaluates whether therapeutic ultrasound (tus) treatment applied to lumbar region with chronic low back pain affect renal function.

low back pain is a common problem and there are many treatments for chronic low back pain, including tus. investigators routinely observed increased blood creatinine and urea levels in some of patients who received tus. half of patients will receive tus treatment for low back pain while the other half will not receive. the patients will be evaluated at baseline and the end of the treatment . the serum creatinine, serum cystatin c, 24-hour urine creatinine, creatinine clearance, 24-hour urine microalbumin and microprotein, urine volume, and gfr will be measured at each evaluation.

Eligibility criteria:
inclusion criteria: * patients aged between 18 and 65 years * with chronic mechanical low back pain for at least 3 months * with glomerular filtration rate (gfr) ≥ 60 ml/min/1.73 m2, as calculated using the modification of diet in renal disease formula . exclusion criteria: * history of lumbar surgery * having inflammatory low back pain * having pregnancy * having active infection * history of malignancy * having coagulation disorder * having a cardiac pacemaker * having heart failure * having uncontrolled hypertension or hypotension * having active psychiatric disease * presence of skin diseases on low back pain * taking medicines for low back pain during the physical therapy treatment (except for paracetamol) * taking a new drug for another disease or undergoing a dose change for a drug taken during the course of physiotherapy.

Keywords: chronic pain physiotherapy renal function
prediction of arterial lactate and blood gas values through the analysis of central venous blood

Conditions: Circulatory Failure

Summary: predicting arterial lactate and blood gas values with sufficient accuracy by simply analyzing central venous blood would be interesting in intensive care unit patients in whom the insertion of an arterial catheter or arterial punctures could be avoided. this prospective study aims at externally validating published mathematical models built to predict arterial values from central venous blood analysis.

mathematical models for predicting arterial blood gas and arterial lactate have recently be published (pmid 27543529; see the citations section). the aim of the study is to externally validate these models in a multicenter (11 centres in france) cohort of intensive care unit patients suffering from acute circulatory failure. for the peru pose of the study, patients will undergo concomitent central venous/arterial blood sampling from 1 to 4 times during their intensive cafe unit stay. clinical characteristics of the patients and central venous blood gas and lactate values will be used to predicted arterial values according to previously published formula. predicted and actual arterial values of each variable of interest (ph, paco2, sao2, lactate) will then be compared.

Eligibility criteria:
inclusion criteria: * age\>18 years * patient admitted in a intensive care unit * patient already carrying an indwelling arterial catheter and a superior vena cava central catheter * patient presenting an acute circulatory failure defined by the presence of at least two of the following items: a) persistent hypotension (systolic arterial blood pressure \ 2 mmol/l or peripheral venous lactate \> 3.2 mmol/l; scvo2 \<70%. * routine medical management requires central venous blood sampling for scvo2 measurement and arterial blood sampling for gazometry. exclusion criteria: * opposition to participation in the study * impossibility to take a concomitant arterial and venous gazometric sample. * patient treated with ecmo (extracorporeal membrane,oxygrnation), intermittent dialysis or continuous dialysis during sampling * patient hospitalized without consent and/or deprived of liberty by court decision.

Keywords: lactate arterial blood gas central venous blood gazometer