Kornimate/medical-research-clean huggingface dataset:
deep brain reorienting in post-traumatic stress disorder

Conditions: PTSD; Post-traumatic Stress Disorder

Summary: this study will evaluate the efficacy of a therapeutic treatment, deep brain reorienting (dbr), for ptsd (post-traumatic stress disorder). participants will be randomized to either the dbr treatment, or wait-list condition.

this study will evaluate the efficacy of deep brain reorienting (dbr) in reducing ptsd symptoms. dbr was designed by dr. frank corrigan, a scottish psychiatrist interested in the brain mechanisms underlying effective trauma psychotherapy. for this study, participants will be randomized to either the dbr treatment or wait-list study conditions. trauma processing through dbr involves bringing up a traumatic memory and encourages the client to focus on tensions arising in the muscles of the shoulders, neck, head and face (i.e., those involved in orienting toward a threatening person/event). it is believed that this approach will allow the participant to process the traumatic memory in an emotionally manageable way, changing how it is represented/accessed in the brain's innate defensive system. online stream - assessments will include clinical interviews (pre/post treatment, and follow-up) using webex video conferencing, and fmri (functional magnetic resonance imaging) scans (pre/post treatment). in-person stream - assessment will include clinical interviews (pre/post treatment and follow-up), and fmri scans (pre/post treatment).

Eligibility criteria:
inclusion criteria: * english speaking * age: 18-65 * meets diagnostic criteria for ptsd (as determined by study assessment) * may benefit from short-term trauma therapy (as determined by study assessment) exclusion criteria: * individuals with any implants, conditions, etc. that do not comply with 7-tesla (7t) fmri research safety standards (e.g., certain implants, pregnancy) * history of significant head injury/lengthy loss of consciousness (e.g., a glasgow coma scale score \< 15 at the time of incident assessed retrospectively by participant) * significant untreated medical illness * history of neurological disorder * history of any pervasive developmental disorder * history of bipolar disorder * history of psychotic disorder * alcohol/substance abuse or dependence within the last 3 months * extensive narcotic use * current participation in counselling more extensive than supportive therapy (e.g., exposure therapy, cognitive-behavioural therapy would be an exclusion) * a degree of mental distress that is unlikely to benefit from a short-term therapy (for our participants' well-being, it will be necessary that we believe it possible to safely address the issues/triggers brought up in treatment within the 8 sessions).

Keywords: deep brain reorienting dbr
umbrealung - a retrospective and prospective, observational, real world multi-cohort study of patients with non-small cell lung cancer (nsclc) initiating approved drugs developed by az or as part of an az alliance

Conditions: Real World Multi-cohort Study of Patients With Non-small Cell Lung Cancer (NSCLC) Initiating Approved Drugs Developed by AZ or as Part of an AZ Alliance

Summary: this is an ambispective, observational, multicenter and multicohort study, targeting patients with nsclc initiating approved drugs developed by az or as part of an az alliance, in the participating countries, as monotherapy or in combination at any stage of disease. three cohorts are designed, based on the stage of nsclc (resectable, unresectable and metastatic). the multicohort study is modular in design. specific modules will be set up separately to assess each new indication of drugs developed by az or as part of an az alliance once european marketing authorization (ma) has been granted and made available in the participating countries. patients will be enrolled in the study if they have received (retrospective), receive (retrospective and prospective) or will receive (prospective) approved drugs developed by az or as part of an az alliance according to the eligibility criteria. treatment plan and decision are made independently by each treating physician prior to inclusion in this study.


Eligibility criteria:
inclusion criteria: * adult patients (≥ 18 years old) * patients with histologically or cytologically proven nsclc * patients initiated with approved drugs developed by az or as part of an az alliance at the time of the enrollment or within the previous three weeks. * informed patients who consent to participate in the study as per local regulations. exclusion criteria: * patients participating in an interventional clinical trial for nsclc\* \* with the exception on low-interventional studies (riph2) where the intervention does not involve the nsclc treatment * patients already enrolled in another module of the cohort in umbrealung * patients under safeguard of justice, curatorship or guardianship

Keywords: observational, real world study, rwe, non-small cell lung cancer, multi-cohort, ambispective, prospective, retrospective, durvalumab, osimertinib
italian registry on the prevalence of idh1/idh2 mutations in patients with acute myeloid leukemia

Conditions: AML, Adult

Summary: this is a study where there are no interventions planned. investigators will only collect data already in the patient's history and analyze it. particularly, we are interested in molecular data from aml patients. this means that patients will follow their regular diagnostic and clinical practice. the analyses will be conducted according to the routine diagnostic and clinical practice as well and no additional blood withdrawal will be performed.

the study will be conducted as follows: 1. retrospective phase clinical and molecular data of patients analyzed for idh1/2 mutations will be retrospectively collected in the centers that have already introduced idh1/2 mutational screening in their practice from cases collected according to standard procedure (ficoll and lysis in rlt buffer). 2. prospective phase: each participating center already performing idh1/2 mutational status on samples of their aml patients at diagnosis or relapse - on freshly isolate mononuclear cells from bone marrow and/or peripheral blood using ficoll density gradient preparation - will prospectively collect the clinical and molecular data.

Eligibility criteria:
inclusion criteria: * signed written informed consent according to ich/eu/gcp and national local laws (if applicable); * aml patients; * age ≥18; * idh mutation test performed at diagnosis or relapse until january 31st, 2019. exclusion criteria: * aml m3 subtype according to the fab classification;
comparison of bioactive glass ceramics spacer and peek cages in posterior lumbar interbody fusion: a prospective, rct

Conditions: Degenerative Lumbar Spinal Stenosis

Summary: the authors aimed to compare the clinical efficacy and safety of cao-sio2-p2o5-b2o3 glass ceramics with peek cage that is widely used for posterior lumbar interbody fusion (plif) surgery in the clinical field.


Eligibility criteria:
inclusion criteria: * patients aged between 30 and 80 * patients who required one-level plif between l1 and s1 among those who required an extensive laminectomy or facetectomy to correct severe disc extrusion or severe spinal stenosis or those who required plif due to grade i or ii spondylolisthesis * those who (only if a signature was obtainable), or whose legal guardian, fully understood the clinical trial details and signed the informed consent form. exclusion criteria: * osteoporosis patients with average t-scores of l1-l4 at \<-3.0 in dexa bone density tests * women with positive pregnancy tests before the trial or who planned to become pregnant within the following 3 years * patients with a history of malignant tumor or malignant diseases (but the cases of cured disease with no relapse for the past 5 years were included in the present study) * patients with abnormal blood potassium and phosphorus levels; * patients with liver disease, kidney disease, respiratory disease, metabolic disease, or psychological disease; * patients deemed to have less than 1-year life expectancy; * patients with mental retardation or whose parents or legal guardians were older or had mental disabilities; * other patients viewed as inappropriate by the staff
study of motexafin gadolinium with whole brain radiation therapy followed by stereotactic radiosurgery boost in the treatment of patients with brain metastases

Conditions: Neoplasm Metastasis; Brain Neoplasms

Summary: the primary purpose of the study is to evaluate if motexafin gadolinium with whole brain radiation therapy followed by a stereotactic radiosurgery boost is a safe and effective treatment.

patients will receive three weeks of whole brain radiation therapy concurrent with daily motexafin gadolinium during weeks 2 and 3, followed by a stereotactic radiosurgery boost concurrent with motexafin gadolinium. patients will be followed for radiologic response, neurologic progression, and neurocognitive progression.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * karnofsky performance status (kps) ≥ 70 * histologically confirmed malignancy with the presence of one to four intraparenchymal brain metastases * each patient must sign a study-specific informed consent form exclusion criteria: * previous cranial radiation * complete resection of all known brain metastases * known leptomeningeal metastases * known liver metastases * clinical or radiologic evidence of progression (other than study lesion\[s) within 1 month prior to enrollment * patients with metastases within 10 mm of the optic apparatus * patients with metastases in the brainstem, midbrain, pons, or medulla * planned chemotherapy during wbrt and/or srs * uncontrolled hypertension * women who are pregnant or lactating and laboratory values as follows: * ldh \> 1.3 x upper limit of normal (uln) * anc \< 1500/mm3 * platelets \< 50,000/mm3 * creatinine \> 2.0 mg/dl * ast or alt \> 3 x uln * total bilirubin \> 2 x uln

Keywords: brain neoplasms/secondary brain neoplasms/radiotherapy brain metastasis neoplasm metastasis cranial irradiation radiosurgery lung neoplasms breast neoplasms kidney neoplasms melanoma radiotherapy carcinoma, non-small cell lung
safety and efficacy of thn102 in patients with parkinson's disease and excessive daytime sleepiness

Conditions: Parkinson Disease

Summary: this is a randomized, placebo-controlled, 3-way cross-over phase iia trial comparing two dose levels of thn102 to placebo in patients suffering from parkinson's disease associated with excessive daytime sleepiness.

the treatment duration is 2 weeks per period. each treatment period is followed by a one-week washout period.

Eligibility criteria:
inclusion criteria: * subjects with a diagnosis of idiopathic parkinson's disease as defined by the movement disorders society (mds). * subjects with hoehn and yahr scale score ≤ 4. * body mass index \> 18 kg/m2 and \< 35 kg/m2. * subjects should have a complaint of daytime sleepiness impacting their quality of life and/or daytime functioning (e.g. falling asleep while reading or watching television, while eating or talking with other people). * epworth sleepiness scale (ess) score ≥ 14. exclusion criteria: * subjects with known or with a suspected sleep apnea syndrome or who have any other cause of excessive daytime sleepiness, such as shift work sleep disorder. * psychiatric and neurological disorders (other than parkinson's disease), * cardiovascular disorders such as - but not limited to * uncontrolled moderate to severe hypertension * history or current diagnosis of electrocardiogram (ecg) abnormalities indicating significant risk of safety for patients participating in the study * recent myocardial infarction * stable or unstable angina pectoris * cardiac insufficiency or history of heart failure * previous history of cardiac valvular surgery * subjects with current impulse control disorder. * subjects showing dementia or with moca \< 23. * subjects with current suicidal risk * current or recent (within one year) history of substance abuse or dependence disorder * other active clinically significant illness * subjects with hepatic or renal impairment
electrical cardiometry compared to transthoracic echocardiography in fluid responsiveness in sepsis

Conditions: Electrical Cardiometry; Transthoracic Echocardiography; Fluid Responsiveness; Sepsis; Stoke Volume

Summary: the aim of this study is to evaluate the diagnostic accuracy of electrical cardiometry (ec) for the noninvasive determination of fluid responsiveness in sepsis and agreement of (ec) compared to transthoracic echocardiography (tte).

usual investigations \[complete blood count (cbc), c reactive protein (crp), serum procalcitonin, serum lactate, arterial blood gases (abg), blood culture, electrocardiogram (ecg) and liver and renal function tests\] will be done. once the diagnosis of sepsis is definite and the patient develops hypotension, all patients will undergo simultaneous measurement by (ec) using the icon_ device and (tte). electrical cardiometry (ec) measurements: by the icon_ hemodynamic monitor (icon cardiotronics, inc., la jolla, ca 92307; osyka medical gmbh, berlin, and germany, model c3, serial no: 1725303). four sensors of (ec) will be applied (1st: 5 cm above the base of the neck, 2nd: on the base of the neck, 3rd: lower thorax at the level of the xiphoid and 4th: 5 cm below the 3rd electrode at the level of the anterior axillary line). the icon continuously displays heart rate, stroke volume, and cardiac output. transthoracic echocardiography (tte) measurements: will be performed by using philips (cx50 - extreme edition) equipped with echo probe. sv of the left ventricle will be calculated using lvot diameter (d) just below the aortic valve from parasternal long-axis view and velocity time integral (vti) measured in left ventricle outflow tract (lvot) from apical 5 chamber view (by pulsed wave doppler), respectively. the machine's built-in software uses the formula ''(πd2/4) × vti × hr'' to calculate co. management of sepsis will be done according to surviving sepsis campaign guidelines in 2016 and its update 2018. fluid resuscitation will be 30 ml/kg of intravenous infusion of lactated ringer to be given within the first 3 h (≈5 ml/kg/30 min) guided by fluid responsiveness (fluid responder if sv increases by \> 10% after the fluid challenge). if the patient becomes fluid non-responder, vasopressor infusion (norepinephrine 0.05-0.3µg/kg/min) will start. the end of the study is when mean arterial blood pressure \> 65 mmhg (either by fluid or both fluid and vasopressor).

Eligibility criteria:
inclusion criteria: * age from 19 to 65 years old. * clinical criteria of sepsis \[acute change in sepsis-related organ failure assessment (sofa) variables ≥ 2 points consequent to the infection which include: pao2/fio2 ratio \ 1.2 mg/dl or urine output \ 1.2 mg/dl, platelet count \< 150 x 103 /µl\]. * developing hypotension (mean arterial blood pressure ≤ 65 mmhg). exclusion criteria: * other causes of shock * previous cardiac disease * rhythm other than sinus rhythm or heart rate \> 140 beats/min * chronic renal failure.
single-portal endoscopic carpal tunnel release versus knifelight for carpal tunnel syndrome. a randomized control trial

Conditions: Carpal Tunnel Syndrome

Summary: the purpose of this study is to determine whether single-portal endoscopic carpal tunnel release (agee technique, smartrelease™, microaire) and mini-open technique (knifelight®, stryker) are equally effective and safe surgical options for the treatment of primary carpal tunnel syndrome.


Eligibility criteria:
inclusion criteria: * primary carpal tunnel syndrome * no symptoms' relief after 3 months of conservative treatment (nsaids, cast, rest) * electrophysiological examination confirms the carpal tunnel syndrome exclusion criteria: * secondary carpal tunnel syndrome * pregnancy * rheumatoid diseases * previous trauma at hand or other condition that may effect the anatomy (eg infections)

Keywords: carpal tunnel syndrome transverse ligament carpal tunnel release endoscopic minimal invasive mini-open median nerve
peripheral vascular reactivity and muscular oxygenation in diabetes mellitus

Conditions: Diabetes Mellitus; Vascular Complications; Mitochondrial Diseases

Summary: oxygen is required for an optimal muscle function. in patients with diabetes mellitus, hyperglycemia can cause vascular complications. the endothelium (inter layer of the blood vessels) can be damaged leading to a reduced oxygen flow towards the muscle cells. besides, it is possible that mitochondrial dysfunction is occuring leading to reduced extraction of oxygen. both conditions will lead to a reduced flow of oxygen towards the muscle and this can have impact on the production of energy necessary for optimal functioning. in this study, the investigators will examine the functionality of the blood vessels (1) and the uptake of oxygen into the muscles (2) in patients with diabetes mellitus type 1 and type 2 (with and without vascular complications) compared to healthy persons.

the investigators plan to recruit in total 125 participants who will be divided into 3 main groups: (i) diabetes mellitus type 1 (with (a) or without (b) vascular complications), (ii) diabetes mellitus type 2 (with (a) or without (b) vascular complications), and (iii) healthy persons. diabetes mellitus will be defined by the guidelines of the american diabetes association (ada). the examinations for this study consist of a blood pressure assessment, flow mediated dilatation (fmd)-measurement, and a handgrip exercise test. the protocol will take approximately 2 hours. the investigator who performs the fmd-test followed a course and passed thorough evaluation. the blood pressure assessment will be continuously for 20 minutes to avoid large bias.

Eligibility criteria:
inclusion criteria: * men and women * age 18-85 years old * diabetes mellitus type 1 or type 2 (with or without vascular complications, healthy participants exclusion criteria: * other types of diabetes mellitus than type 1 or type 2 * alcohol abuse * active cancer * pregnancy

Keywords: diabetes mellitus muscular oxygenation vascular function
study of adalimumab administered as subcutaneous injections in adult chinese rheumatoid arthritis subjects treated with methotrexate

Conditions: Rheumatoid Arthritis

Summary: a randomized, double-blind, placebo-controlled, study of the adalimumab administered as subcutaneous injections in adult chinese rheumatoid arthritis subjects treated with methotrexate


Eligibility criteria:
inclusion criteria: * meet acr criteria for diagnosis of active ra and have at both screening and baseline visits 6 swollen joints and 9 tender joints. exclusion criteria: * a history of, or current, acute inflammatory joint disease of different origin than ra (e.g., mixed connective tissue disease, seronegative spondyloarthropathy, psoriatic arthritis, reiter's syndrome, systemic lupus erythematosus or any arthritide with onset prior to age 16 years).
hes and acute kidney injury in adult cardiac surgery

Conditions: Acute Kidney Injury After Adult Cardiac Surgery

Summary: this study retrospectively assess the effect or using balanced hydroxyethyl sctarch (hes) 130/0.4 or a balanced crystalloid solution as a pump prime and for intraoperative fluid therapy on the risk of early acute postoperative kidney injury in adult cardiac surgery patients.


Eligibility criteria:
inclusion criteria: * age ≥ 18 yo * having on pump cardiac surgery at chu of liège between april 2013 and june 2014 exclusion criteria: * off pump surgery * use of blood or albumin in the cardiopulmonary bypass priming solution * preoperative dialysis
a study of migalastat in fabry disease

Conditions: Fabry Disease

Summary: fabry disease is a rare metabolic condition characterised by the widespread deposition of sphingolipids in multiple organ systems. cardiac involvement is common, it occurs in fifty percent of patients and it is the leading cause of death. despite this, heart and blood vessel (cardiovascular system) manifestations of fabry disease remain poorly characterised, and it remains unclear which patients benefit from therapy, or when therapy should be initiated. migalastat is increasingly used to treat fabry disease however the impact of migalastat on the cardiovascular system is poorly understood. detailed assessment of the impact of migalastat on heart and blood vessel structure and function is urgently needed. this observational study will use state of the art, non-invasive investigations to provide greater understanding of the cardiovascular manifestations of fabry disease and the effects of migalastat. it will provide insight into which patients respond more effectively to migalastat, which in turn will facilitate personalisation of therapy, optimisation of the timing of therapy initiation and more cost-effective care.

this is a prospective longitudinal observational study of patients starting migalastat as part of routine care. participants will be recruited from outpatient clinics and have a number of investigations before starting therapy and after twelve months of therapy. investigations will include a detailed assessment of symptoms and clinical features, blood tests, echocardiography, detailed cardiac mri scans, heart rhythm monitoring and exercise capacity assessment. parameters will be assessed at baseline and at twelve months.

Eligibility criteria:
inclusion criteria: confirmed fabry disease aged 16 or over beginning clinical treatment with migalastat exclusion criteria: contraindication to cardiac mri

Keywords: fabry anderson-fabry migalastat