Kornimate/medical-research-clean huggingface dataset:
uhw angiogram video project

Conditions: Anxiety

Summary: this study is a randomised control trial which aims to assess whether the use of an immersive virtual reality angiogram experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation.

patients undergoing cardiac catheterisation are understandably anxious. this is due to a lack of familiarity with both the hospital environment and the planned procedure. anxiety may negatively affect their patient experience. appropriate patient information can help improve understanding and reduce anxiety. in particular, video-based patient information prior to cardiac catheterisation has been shown to improve patient's knowledge and reduce peri-procedural anxiety. generic video-based patient information about the cardiac catheterisation procedure is widely available. ideally any patient information delivered pre-cardiac catheterization would be specific to the hospital delivering care. the use of virtual reality (vr) in healthcare is novel, but expanding rapidly. the immersive nature of vr allows patients a unique opportunity to prepare for the procedure and environment within which they will be treated. to date, the use of vr to prepare patients for invasive cardiac procedures has not been studied. the aim of this study is to assess whether the use of an immersive vr experience decreases peri-procedural anxiety in patients undergoing cardiac catheterisation. the investigators will also assess whether the vr experience improves overall patient satisfaction. with the help of a local media company, a vr cardiac catheterisation video was produced (figure 1 depicts a screenshot from the vr video). the video is watched with a vr headset to create a 360 immersive experience. the investigators are undertaking a single-centre randomised control trial comparing the use of an immersive vr experience 1 week prior to catheterisation with standard pre-procedural care. pre procedural anxiety levels and procedural knowledge are assessed by questionnaire, using the validated six-item short-form of the strait trait anxiety inventory (stai). a satisfaction questionnaire is also completed before the patient is discharged.

Eligibility criteria:
inclusion criteria: - all patients undergoing their first cardiac catheterisation exclusion criteria: * patients who cannot comprehend english or welsh * those who have significant visual or auditory impairment meaning they would be unable to fully appreciate the video material
reduction of asthma exacerbation rate in children by non-invasive monitoring of inflammatory markers in exhaled breath (condensate): the raster study

Conditions: Asthma; Children; Home Monitoring; Exhaled Breath Condensate; Non-invasive Inflammatory Markers; Volatile Organic Compounds

Summary: the purpose of the present proposal was to investigate the predictive properties of markers in exhaled breath to predict an asthma exacerbation. in addition, the reliability of home monitor assessments to measure asthma control will be examined.


Eligibility criteria:
inclusion criteria: 1. already known with a diagnosis of asthma during at least 6 months 2. age between 6 and 17 years 3. reversibility to a bronchodilator (increase in fev1 \> 9% of predicted value and/or 4. bronchial hyperresponsiveness to histamine \< 8 mg/ml. exclusion criteria: 1. cardiac abnormalities 2. mental retardation, congenital abnormalities or existence of a syndrome 3. active smoking 4. no technical satisfactory performance of measurements 5. no phone line or internet assess available at home.

Keywords: asthma children home monitoring exhaled breath condensate non-invasive inflammatory markers volatile organic compounds
desarda repair for inguinal hernia

Conditions: Inguinal Hernia

Summary: unlike lichtenstein tension free repair for inguinal hernia, desarda's repair was introduced as a pure tissue repair with no need for mesh. in other words; the complications which may arise from the use of a foreign body (mesh) will be avoided. the idea was to evaluate the efficacy of this new repair and compare it to the standard lichtenstein repair.


Eligibility criteria:
inclusion criteria: * inguinal hernia exclusion criteria: * recurrent inguinal hernia * giant inguinal hernia * mental disorder * refusal to participate
a study of bms-986036 in subjects with non-alcoholic steatohepatitis (nash)

Conditions: Non-Alcoholic Steatohepatitis

Summary: the purpose of this study is to determine whether bms-986036 is effective in the treatment of subjects with non-alcoholic steatohepatitis (nash).


Eligibility criteria:
for more information regarding bms clinical trial participation, please visit www.bmsstudyconnect.com inclusion criteria: * male or female between 21 and 75 years old * body mass index (bmi) of 25 or more exclusion criteria: * chronic liver disease other than nash * uncontrolled diabetes * any major surgery within 6 weeks of screening * unable to self-administer under the skin injections * any bone trauma, fracture or bone surgery within 8 weeks of screening

Keywords: first line therapy nash
glass classification and clti

Conditions: Chronic Limb-Threatening Ischemia Nos of Native Arteries of Extremities

Summary: critical limb threatening ischemia "clti 'is not a separate local disease but also it is a part of generalized vascular disorder. a clinical syndrome that can be presented by many symptoms and signs as rest pain, gangrene and chronic ulceration more than 2 weeks (1).

the global vascular guidelines 'gvg "proposes a new global anatomic staging system (glass), glass incorporates two novel and important concepts, the target arterial path (tap) and estimated limb-based patency (lbp). based on appropriate angiographic imaging, the tap is defined by the treating surgeon or internationalist as the optimal arterial pathway to restore in-line (pulsatile) flow to the ankle and foot. lbp allows more direct comparison of anatomic outcomes across revascularization strategies in clti. the complexity of disease traversed by the tap is integrated in the glass. femoropopliteal (fp) and infrapopliteal (ip) arterial segments are individually graded on a scale of 0 to 4.(2)(3) using a consensus based matrix, these segmental grades are combined into three overall glass (i-iii) stages for the limb, reflecting the complexity of the disease with a proposed likelihood of immediate technical failure ' itf " and 1 year "lbp " after endovascular intervention of " tap ' (1)

Eligibility criteria:
inclusion criteria: * patients with infrainguinal clti exclusion criteria: * patients with concomitant aorto-iliac lesions * acute ischemia patients * post traumatic ischemia
clinical evaluation of the sonr atrial lead in paradym rf device

Conditions: Heart Failure

Summary: sorin group has developed a new atrial lead which is under evaluation during this study. the sonr atrial lead presents a new sensor in the tip of the lead and allows a new feature; interventricular (vv) and atrioventricular (av) delay (vvd and avd) optimization. the new rv autothreshold algorithm has been implemented in the crt-icd and will help the physician in his diagnosis avoiding potential lost of capture. the icd device has also the capability to be remotely interrogated through the remote monitoring system whose performances will be reported during the study. finally, the study will report the electrical and handling performances of the new left ventricular lead.

in this study, the sponsor aims at: * demonstrating the safety of the atrial sonr lead; * demonstrating the performances of the right ventricular autothreshold algorithm ; * reporting the adverse events documented in the study; * reporting electrical performances of sorin group paradym icd, in order to validate that the performances of those devices are in conformance with longevity and effectiveness objectives; * reporting the sorin atrial sonr and situs 2 mv left ventricular leads performances; * reporting the sonr atrial lead mechanical handling. * reporting all information from sonr sensor to validate the sonr data exploitation and the avd/vvd optimization. * reporting the situs 2 mv lv lead mechanical handling. * assessing the user satisfaction (patient and physician) of the remote monitoring solution and the overall availability of the system in terms of data. thus, this study intends to show that paradym rf icd operate safely and appropriately in intended-use as part of an icd system.

Eligibility criteria:
inclusion criteria: * patient eligible for implantation of a crt 9770 device accordingly to the relevant currently-approved acc/aha/esc guidelines or any relevant currently approved local guidelines for the implantation or replacement of triple-chamber icd * implanted with atrial sonr lead * signed and dated informed consent exclusion criteria: * vt/vf is associated with drug toxicity, electrolyte imbalance, hypoxia, or other reversible cause; * vt/vf occurred during the acute phase of infarction (\< 3 weeks) or during an unstable ischemic phase; * vf was caused by electrocution; * incessant vt/vf; * patient is unable to attend the scheduled follow-ups at the implanting centre; * patient is already enrolled in another ongoing clinical study; * patient is unable to understand the aim of the study and its procedure; * patient refuses to cooperate; * patient is unable or refuses to provide informed consent; * patient is minor (less than 18-year old); * patient is pregnant; * patient has life expectancy of less than 1 year; * patient is forfeiture of freedom or under guardianship.

Keywords: icd crt 9770 - paradym rf icd - sonr atrial lead
short and long term prognosis of patients admitted to the ed with acute heart failure

Conditions: Acute Heart Failure

Summary: heart failure (hf) is the leading cause of hospitalization ,rehospitalization and mortality for adults over 65 years of age. this study aimed to assess mortality, and hospitalization rates at 30 days and one year after dicharge of patients with heart failure (hf) with reduced ejection fraction (hfref) compared to hf with preserved ejection fraction (hfpef).


Eligibility criteria:
inclusion criteria: * patients admitted to the ed of monastir with a principal discharge diagnosis code for hf. exclusion criteria: * pregnant or breast feeding women. alteration of consciousness gcs \< 15 critically ill patients needing immediate mechanical hemodynamic of ventilatory support. inability to follow instructions or comply with follow-up procedures.

Keywords: acute heart failure prognosis
the melacare study: a new method for surveillance of melanoma patients

Conditions: Cutaneous Melanoma

Summary: the aim of this study is to evaluate a new method of follow-up for patients with low and intermediate risk (stages ia-iia) melanoma. the investigators will compare different tools for patient support and education combined with clinician supported skin self-examination (sse) to the current standard-of-care. the hypothesis is that meta-cognitive strategies and clinician supported sse can lower fear of cancer recurrence (fcr) and promote effective sse on a regular basis without compromising the detection of new primary melanomas and/or metastases.


Eligibility criteria:
inclusion criteria: * ability to read and understand danish language * willing and able to give written informed consent * surgical treatment of a clinical stage ia-iia melanoma within 3 months of inclusion exclusion criteria: * advanced melanoma, clinical stages iib, iic, iii, or iv * patients with high risk of a new primary melanoma (dysplastic nevus syndrome, or family history of melanoma) * history of melanoma skin cancer prior to the index diagnosis * previous cancer, excluding non-melanoma skin cancer * comorbidity that makes skin self-examination impossible (e.g. physical or mental disabilities, dementia or decreased cognitive function) * non-detection of sentinel node in ib and iia patients

Keywords: cutaneous melanoma follow-up nurse-led follow-up skin self-examination survivorship
post-marketing surveillance (special use-results surveillance) on long-term use with tresiba®

Conditions: Diabetes Mellitus, Type 1; Diabetes Mellitus, Type 2

Summary: this study is conducted in asia. the aim of this post marketing surveillance (pms) is to assess safety and effectiveness of long-term treatment with tresiba® (insulin degludec) in patients with diabetes mellitus requiring insulin therapy under normal clinical practice conditions. a total of 4000 patients will be enrolled to investigate long term (3 years of treatment) safety of tresiba® and additional 2000 patients will be enrolled to assess the safety in an early stage of the pms more precisely. at the time of enrolment the patients will be randomly allocated to either 3 years or 6 months observation group.


Eligibility criteria:
inclusion criteria: * patients with diabetes mellitus requiring insulin therapy for whom the treating physician has decided to start tresiba® treatment exclusion criteria: * patients who are or have previously been on tresiba® therapy * patients who have previously been participating in this pms
transinguinal periperitoneal technique in inguinal hernioplasty

Conditions: Hernia, Inguinal

Summary: evaluation of feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh inguinal hernia repair in general surgery department in assiut university hospitals

inguinal hernia repair is one of the most commonly performed surgical procedures worldwide with approximately 20 million cases every year . the open lichtenstein tension-free hernioplasty is most commonly performed and recognized for its low recurrence rate and short learning curve, but associated with an undesirably high level of postoperative chronic groin pain, up to 10-35% . therefore, chronic groin pain is a common concern after inguinal hernia surgery. treatment of chronic groin pain can be challenging and may require several interventions including, local anaesthesia , corticosteroids or additional surgery . several studies showed that chronic groin pain might be dependent on the surgical technique, including identification and handling of inguinal nerves ,preperitoneal techniques like the transinguinal preperitoneal patch (tipp )have been developed to minimize these risks. the tipp technique which introduced by prissier involves a standard anterior inguinal approach, with high dissection and preperitoneal reduction use of a polysoft mesh have been proved to cause less chronic pain than the lichtenstein technique. the polysoft mesh is a lightweight polypropylene mesh, tailored in asymmetric oval shape that contains a recoil ring. recent studies deficient in evaluation feasibility and efficacy of trans inguinal periperitoneal technique by using conventional mesh in inguinal hernia repair . so the aim of our study to evaluate the use of conventional mesh in transinguinal preperitoneal technique in inguinal hernioplasty .

Eligibility criteria:
inclusion criteria: * patients more than 18 years * fit for surgery. exclusion criteria: * patients less than 18 years * american society of anesthesiologists (asa) 3 : a patient with severe systemic disease as ( poorly treated hypertension or diabetes , morbid obesity , chronic renal failure , stable angina \& implanted pacemaker ) .
stellate ganglion block to reduce hot flushes

Conditions: Hot Flash; Stellate Ganglion Block; Postmenopausal; Hot Flushes

Summary: to assess the short-term efficacy of stellate ganglion block on hot flush reduction versus sham procedure

hot flushes are the most common symptom of menopause for which postmenopausal (pmp) women seek medical help, in 20% of pmp women hot flushes can persist for up to 15 years. a possible treatment for hot flushes is stellate ganglion block (sgb), used as a means to interrupt parts of the sympathetic nervous system involved in temperature regulation. single centre randomized double blind placebo controlled intervention study study period of 6 months in which patients will fill out on set time points 5 questionnaires regarding quality of life and keep a diary on hot flush frequency and severity during1 week on the same time points. study population: postmenopausal women aged 30-70 years old with no other causes of flushing present. intervention (if applicable) intervention: stellate ganglion block versus sham procedure follow up with questionnaires during 6 months.

Eligibility criteria:
inclusion criteria: * female * age: 30-70 years * mean daily flush frequency of 10 or more and a hot flush score of 15 or more * absence of any non-menopausal cause of flushing * post-menopause amenorrhea for more than 1 year in healthy postmenopausal women * in case of breast cancer or ovariectomy induced menopause: ovariectomy for \> 6 months. adjuvant therapy with estrogen-receptor blocker or an aromatase inhibitor. exclusion criteria: * use of medication that affects flushing:oestrogens, progestogens, clonidine, naloxone, paroxetine, fluoxetine, venlafaxine, gabapentin, luteïniserend hormone releasing hormones receptor antagonist * receiving chemotherapy of radiotherapy * active psychiatric disease * active concurrent disease * allergic reactions against local anesthetics of the 'amide' type or contrast media.
lixisenatide for restoration of insulin release in subjects with diabetes mellitus type 2

Conditions: Diabetes Mellitus, Type 2

Summary: the objective of this study is to test whether lixisenatide (ave0010) restores first phase and improves second phase insulin response in subjects with diabetes mellitus type 2.


Eligibility criteria:
inclusion criteria: * male and female subjects with type 2 diabetes mellitus on diet and exercise with/without metformin * hba1c\>=6,0 % and \<=8,5 % at screening * bmi 25 to 35 kg/m² * 155\>=bp systolic \>=90 mmhg * 100\>=bp diastolic\>=45 mmhg the above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

Keywords: insulin release diabetes mellitus type 2 glp-1 agonist
efficacy of epidural etanercept in the treatment of sciatica

Conditions: Sciatica

Summary: tumor necrosis factor (tnf)-alpha has been strongly implicated as a major contributing factor for the development of radiculopathy. in animal studies, the application of tnf-alpha to nerve roots results in pain behavior indicative of radiculopathy. the use of tnf-alpha inhibitors (etanercept and infliximab) have been shown to prevent this pain behavior. open-label studies in humans have shown both etanercept and infliximab provide excellent, long-term relief in patients with acute radiculopathy from herniated disc. however, a recent placebo-controlled study failed to demonstrate any significant difference from placebo. the investigators have already established the safety of neuraxial etanercept in a trial that has just been completed (not yet published). the objective of this study is to determine whether small doses of epidural etanercept, an anti-tnf-a medication, is an effective treatment for lbp caused by nerve root irritation (i.e., radiculopathy).

as per the wishes of the dept. of the army and walter reed army medical center dept. of clinical investigation, patients will be randomized in a 3:1 ratio to receive 2 transforaminal epidural etanercept or saline injections at 2-week intervals. both patients and physicians will be blinded as to the injectate and treatment group. there will be 3 study groups. group i will receive either 2 mg of etanercept or saline per injection. group ii will receive either 4 mg of etanercept or saline per injection. group iii will receive either 6 mg of etanercept or saline per injection. in each group there will be 8 patients: 6 who receive etanercept and 2 who receive saline. as per a previous study we just completed, etanercept doses will not be escalated until all 6 patients have completed their 1-month follow-up visits without any evidence of toxicity or complications.

Eligibility criteria:
inclusion criteria: 1. chronic low back pain of radicular origin of \> 2 months but \< 1 year duration. 2. failure of conservative therapy to include physical and pharmacotherapy. 3. mri evidence of a herniated disc corresponding to the patient's radicular symptoms. 4. normal white blood cell count (drawn in 1 blood vial). exclusion criteria: 1. uncontrolled coagulopathy. 2. pregnancy, which will be ruled out by a urine pregnancy test if any question as to the patient's status exists. 3. allergy to contrast dye. 4. unstable medical condition (e.g., unstable angina or congestive heart failure). 5. rheumatoid arthritis, crohn's disease or spondylarthropathy. 6. unstable neurological condition (e.g., multiple sclerosis) 7. systemic infection 8. age \ 70 years.

Keywords: sciatica low back pain epidural tumor necrosis factor
balloon-expandable des for icas registry study (bdes-icas registry)

Conditions: Atheroscleroses, Cerebral; Intracranial Atherosclerosis; Ischemia Stroke

Summary: to study the clinical outcomes after implantation of balloon-expandable drug-eluting stents in patients with symptomatic intracranial atherosclerotic stenosis in prevention of composite event of any stroke and death within 30 days and ischemic stroke in the territories of the responsible artery from 31 days to 1-year.

this study is a prospective, multi-center, real world, registry study. this study aimed to evaluate the effectiveness of balloon-expandable drug-eluting stents in treating stenosis in the c2-c7 segments of the internal carotid artery and v4 artery which with high prevalence of calcified plaques in icad.

Eligibility criteria:
inclusion criteria: 1. age ≥ 18 years. 2. according to clinical and angiographic evidence, symptomatic intracranial arteries stenosis within 3 months include vertebral artery v4 segment or internal carotid artery c2-c7 segment, and the degree of diseased arterial stenosis is between 70%\~99% (wasid method). 3. patients have more than 1 episode of symptoms including stroke or transient ischemia attack (tia) after intensive medical treatment (including antiplatelet therapy, antihypertensive, hypoglycemic and lipid-lowering treatments). 4. patients have at least 1 risk factor for intracranial atherosclerosis, including previous or existing hypertension, hyperlipidemia, diabetes mellitus, smoking, alcohol consumption, obesity, underlying heart disease, family history of atherosclerotic vascular disease, hyperhomocysteinemia and so on. 5. baseline mrs score ≤3. 6. patient or guardian signs informed consent. exclusion criteria: 1. patients who cannot receive dual antiplatelet therapy due to existing diseases or with server coagulation dysfunction, uncontrolled serious infections, serious systemic diseases, uncontrollable hypertension and other conditions are not suitable for surgery. 2. patients with aneurysm that cannot be treated in advance or at the same time or are not suitable for surgery. 3. gastrointestinal disease with active bleeding. 4. myocardial infarction or massive cerebral infarction within 2 weeks. 5. patients with known severe allergies or contraindications to heparin, rapamycin, anesthesia and contrast media. 6. life expectancy \&lt;12 months. 7. according to the judgement of the investigator, other situations that are not suitable for enrollment.

Keywords: intracranial atherosclerosis stroke drug-eluting stent