Kornimate/medical-research-clean huggingface dataset:
efficacy on anxiety of the digital music application versus equimolar mixture of oxygen and nitrous oxide in patients receiving ct-guided lumbar infiltration

Conditions: Low Back Pain; Anxiety

Summary: since the covid-19 crisis, patients appear more stressed, with increasing fear of exams and the hospital environment, in particular for ct scan teams, which require injections. currently, an equimolar mixture of oxygen and nitrous oxide (emono) is used to calm patients. however, the patient's prone position complicates its use, with patients sometimes in painful position and the discomfort of gas inhalation (nausea, dizziness, etc.), as well as reduced lung capacity. greater patient anxiety increases the risk of complications, or even failure, (unexpected movement, stiffness, refusal to complete the procedure, etc.). in this study, music therapy using music care® tablets, was tested to replace emono. the study authors hypothesize that the use of the music care® device will have a comparable efficacy to that of emono (non-inferiority) in reducing patient anxiety during ct-guided lumbar infiltration. furthermore, the study authors hypothesize that this simple, non-invasive method, with no contraindications for the patient, will be better tolerated and appreciated by both the patient and the paramedical team in charge of the treatment.


Eligibility criteria:
inclusion criteria: * the patient must have given their free and informed consent and signed the consent form * the patient must be a member or beneficiary of a health insurance plan * patient with low back pain and an indication for ct-guided foraminal, posterior joint, or pudendal injection * patient with an anxiety score ≥ 35/100 based on the stai-etat questionnaire exclusion criteria: * the subject is participating in another drug or category i interventional study, or is in a period of exclusion determined by a previous study * the subject refuses to sign the consent * it is impossible to give the subject informed information * the patient is under safeguard of justice or state guardianship * patient who has already received a ct-guided posterior articular, foraminal, epidural, or pudendal injection * indication for epidural or cervical injection * patient who is deaf or hard of hearing * contraindications to emono * facial or head trauma making it impossible to wear a nasofacial mask or headphones * patient who has taken an anxiolytic medication within 24 hours prior to the injection

Keywords: music therapy computerized tomography scan enomo radiographer
cd4-specific car t cells (cd4 car t cells) for relapsed/refractory t cell malignancies

Conditions: T Cell Lymphoma in Relapse; Refractory T-Cell Lymphoma

Summary: this is a phase i, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of cd4 car t cells in patients with relapsed and/or refractory t cell lymphoma.

cd4-specific car is a chimeric antigen receptor immunotherapy treatment designed to treat lymphoma/leukemia expressing cd4 antigen. cd4+ t cell lymphomas are a subset of leukemias and lymphomas that are positive for the surface protein cd4. the purpose of this study is to evaluate the efficacy and safety of cd4 car t cells.

Eligibility criteria:
inclusion criteria: * signed written informed consent; patients volunteer to participate in the research * diagnosis is mainly based on the world health organization (who) 2008 * patients have exhausted standard therapeutic options * systematic usage of immunosuppressive drug or corticosteroid must have been stopped for more than 1 weeks * female must be not pregnant during the study exclusion criteria: * patients declining to consent for treatment * prior solid organ transplantation * potentially curative therapy including chemotherapy or hematopoietic cell transplant * any drug used for gvhd must be stopped \>1 week

Keywords: cd4-specific car t t cell leukemia t cell lymphoma cd4car
a study comparing the efficacy and tolerability of ziprasidone vs. clozapine for the treatment of schizophrenia in patients who continue to have symptoms on or cannot tolerate other antipsychotic drugs

Conditions: Schizophrenia

Summary: the purpose of this study is to compare the efficacy and safety of ziprasidone and clozapine in schizophrenic patients who are resistant and/or intolerant to antipsychotic treatment


Eligibility criteria:
inclusion criteria: * cgi - s ≥4 * panss ≥ 80 * inpatients or outpatients exclusion criteria: * patients with a history of myeloproliferative diseases, history of granulocytopenia, agranulocytosis due to a drug * diagnosis of substance dependence within previous 3 months using dsm-iv criteria * history of seizure * organic mental disease, including mental retardation or epilepsy
ai models for non-invasive glycaemic event detection using ecg in type 1 diabetics

Conditions: Metabolic Disease

Summary: this observational study aims to recruit up to thirty t1dm patients from a diabetic outpatient clinic at the university hospital coventry and warwickshire for a two-phase study. the first phase involves attending an inpatient protocol for up to thirty-six hours in a calorimetry room at the human metabolism research unit under controlled conditions, followed by a phase of free-living, for up to three days, in which participants will go about their normal daily activities without restriction. throughout the study, the participants will wear commercially available wearable sensors to measure and record physiological signals (e.g., electrocardiogram and continuous glucose monitor). data collected will be used to develop and validate an ai model using state-of-the-art deep-learning methods for the purpose of non-invasive glycaemic event detection.

the study volunteers will be asked to an attend an 'inpatient' facility for up to 36 hrs dedicated to advanced metabolic measurement (hmru). they will be asked to consume prepared meals of varying macronutrient content as part of a balanced diet, and performed prescribed physical activity. during this time the volunteers will be measured by instrumentation which will investigate the chemical concentration in respired gases (e.g. whole-body calorimeters, metabolic carts); bloods, saliva and urine samples will be taken. if the participant then wishes, we will ask them to continue to wear the wearable devices in a home setting for a maximum one week. the data derived from this study will allow new tools and mathematical models to be developed that can be used to analyse and simulate patient metabolic response. it is envisaged this study will give further evidence to support future research into glucose utilisation in diseased metabolic populations.

Eligibility criteria:
inclusion criteria: the study will be open to all individuals living independently, over 18 years without acute illness or ongoing clinical investigation, or volunteers with a stable medical condition may be included. volunteers with an ongoing medical condition will only be included after detailed consultation with our clinical and dietetics members of the team; however, it is imperative that volunteers are able to provide written informed consent. exclusion criteria: whilst the study employs a deliberately open inclusion criterion, the following exclusion measures will be employed: * children (under 18 yrs) * any adult who lacks decisional capacity * claustrophobia, isolophobia, recent abnormal exercise, radiation exposure within the preceding 24 hours of entering the whole-body calorimeter and feeling unwell in any way. * needle phobia * any medical/endocrine problem that could affect energy expenditure (e.g. thyroid problems, cushing's syndrome) * chronic inflammatory disorders like rheumatoid arthritis, or long term use of steroids or other immunomodulators like cyclosporine, azathioprine. * beta blockers * currently actively losing weight * depression or any psychiatric illness

Keywords: endochrine
the trial of ewata balloon guiding in the application of thrombectomy

Conditions: Acute Ischemic Stroke

Summary: to evaluate the efficacy and security of ewata combined with a stent device in the treatment of acute ischemic stroke within 8 hours to prove whether the clinical efficacy and safety of ewata r is not inferior to other guidings.

this clinical trial uses multicenter, single-arm, prospective trial design,people who met the enrollment requirements were performed with ewata balloon guiding and stent type thrombectomy device.the clinical results were compared with those of other historical guiding catheter products combined with the stent type thrombectomy device to to evaluate the clinical efficacy and safety of ewata balloon guide catheter in combination with a stent for thrombectomy.

Eligibility criteria:
inclusion criteria: 1. acute ischemic stroke 2. within 8 hours 3. patients aged 18-80 years (including critical point) 4. nihss score 4-30 (including critical points) 5. pre-onset mrs score \<2 6. large vessel lesions were detected by head ct, cta, mri, mra, or dsa 7. the patient or his legal guardian voluntarily signs and dates a written informed 8.consent approved by the ethics committee (ibc). exclusion criteria: 1. head ct exclusion criteria (exclusion if any of the following conditions are met) 2. cerebral hemorrhage 3. intracranial tumors, except for small meningiomas 4. large area of early cerebral infarction (low density shadow \>1/3 cerebral hemisphere) clinical and laboratory exclusion criteria 1. seizure 2. symptoms of nervous system loss improved rapidly 3. severe stroke (nihss≥31 points) or mild stroke (nihss≤3 points) 4. ct examination of the skull was negative, but subarachnoid hemorrhage was not excluded from clinical symptoms 5. a history of intracranial hemorrhage and subarachnoid hemorrhage 6. a history of cranial trauma in the last 3 months 7. a history of cerebral or myocardial infarction in the last 3 months 8. a history of gastrointestinal or urinary tract bleeding in the last 3 weeks 9. a history of major surgery in the last 2 weeks 10. a history of arterial puncture in the last l weeks that was difficult to stop bleeding 11. patients with severe cardiac, hepatic or renal insufficiency (\>250 mol/l) or severe diabetes mellitus 12. physical examination revealed evidence of active bleeding or trauma, such as a fracture 13. oral anticoagulants have been taken, and inr\>1.7 14. blood glucose \ 22.2 mmol/l 15. systolic blood pressure \>185 mmhg, or diastolic blood pressure \>110 mmhg pregnancy 16. there is a tendency of severe bleeding or bleeding disease, platelet count ≤80x109 /l 17. systemic infection without control or local infection of puncture point hypersensitivity to contrast media

Keywords: ais balloon guiding
a study about the selection of time for retreatment of helicobacter pylori after eradication failure

Conditions: Helicobacter Pylori Infection

Summary: the patients who accepted the quadruple eradication program of the helicobacter pylori but failed to eradicate helicobacter pylori will be assessed the most suitable re-eradication time of helicobacter pylori.

helicobacter pylori (hp) infection is a common global infectious disease, which is an important cause of chronic gastritis, peptic ulcer and gastric cancer. at present, due to the non-standard helicobacter pylori eradication program in clinical work, poor patient compliance and other reasons, the phenomenon of hp eradication treatment failure is more and more common. however, there is still no conclusion on the most appropriate time for remedial treatment inpatients with hp eradication failure.

Eligibility criteria:
inclusion criteria: * patients aged 18-70 with h. pylori infection. * patients with previous helicobacter pylori eradication. exclusion criteria: * patients treated with h2-receptor antagonist, ppi, bismuth and antibioticsin the previous 4 weeks. * patients with gastrectomy, acute gi bleeding and advanced gastric cancer. * patients with known or suspected allergy to study medications. * currently pregnant or lactating. * inability to provide informed consent and other situations that couldinterfere with the examination or therapeutic protocol.
postapproval trial on carotid stenting in patients with high risk vs standard risk for open carotid endarterectomy(real)

Conditions: Carotid Artery Diseases

Summary: until the irruption of the carotid revascularization endarterectomy versus stenting trial (crest), carotid stenting (cas) has been mainly offered to those patients considered at "high risk" for open carotid endarterectomy (cea) based on the available data from large randomized clinical trials. "high risk" has been defined as (1) patients with severe comorbidity (class iii/iv congestive heart failure, class iii/iv angina, coronary disease involving ≥ 2 major vessels, left ventricular ejection fraction ≤ 30%, myocardial infarction, severe pulmonary disease, severe renal failure) and (2) technical/challenging anatomical criteria (previous neck surgery, cervical irradiation, contralateral carotid occlusion, post-endarterectomy restenosis, inaccessible lesions or tracheotomy). several recent studies have called medical "high-risk" into question for cas indication. the purpose of this study is to evaluate the safety and perioperative and long-term effectiveness in patients with significant carotid artery stenosis with "high-risk" criteria (for cea) treated with carotid stenting and proximal protection device (moma®) compared to patients with standard-surgical-risk features.


Eligibility criteria:
inclusion criteria: * symptomatic patients who have a transient ischemic attack, amaurosis fugax, or minor nondisabling stroke in the distribution of the study artery within 180 days of inclusion and have been shown carotid artery stenosis ≥50% by angiography, ≥70% by ultrasound, or ≥70% by ct angiography or mr angiography if ultrasound is 50% to 69% * asymptomatic patients who have carotid artery stenosis of ≥60% by angiography, ≥70% by ultrasound, or ≥80% by ct angiography or mr angiography if ultrasound is 50% to 69% exclusion criteria: * patient is unable to respond to external questions and stimuli and to exert a pressure with the contralateral hand * patient has an myocardial infarction within 72 hours prior to carotid stenting * patient has a major residual neurological deficit (stroke scales: barthel ≤ 60, nih ≥ 15 or rankin \>3) at pre-procedure neurological exam * patient had a transient ischemic attack (tia) or amaurosis fugax within 48 hours prior to index procedure * patient had a stroke or retinal artery occlusion within 1 month prior to index procedure * patient has severe chronic renal failure (creatinine \> 2.5mg/dl) * the target carotid artery is completely occluded * the common carotid artery ostium has stenosis that required treatment * the presence of ipsilateral intracranial stenosis that requires treatment * the inability to position a stiff 0.035" guidewire in the external carotid artery * contralateral occlusion of internal carotid artery and vertebral arteries
genzyme osteopenia/osteoporosis study

Conditions: Gaucher Disease

Summary: gaucher disease is a most common genetic metabolic disease characterized by low platelet number, liver and spleen enlargement and various forms of bone diseases including low bone mineral density leading to brittle bones. various treatment options are now available for this disease. the purpose of this research study is to determine the prevalence of gaucher disease in patients with low bone mineral density as observed by dexa scan, which is a form of x-ray of the bone.

gaucher disease is a potential secondary cause of low bone mineral density and it is prevalent among patients with low bmd. this cross sectional design study will measure point prevalence of gaucher disease in patients with low bone mineral density (bmd).

Eligibility criteria:
inclusion criteria: * patients \> or equal to18 years and able to provide written consent. * patients who have had a bone density test demonstrating t-score \<-1.0 on a dexa scan within the past year or those who are prospectively referred for dexa scan and who are later identified by their physician to have a dexa t-score \< -1.0. exclusion criteria: * subject unable to read and sign consent form. * terminally ill subjects or subjects with serious co-morbidities (malignancy), which would limit the ability of the patient to participate in the study. * subjects with the following disorders or exposures * underlying skeletal dysplasia * an endocrinologic/metabolic disease known to cause bone demineralization: including parathyroid dysfunction, hyperthyroidism, cushing syndrome, hypogonadism, panhypopituitarism * cystic fibrosis * exposure to medications that are known to cause low bmd including chemotherapy within past 2 years, chronic corticosteroid or phenytoin use within past 2 years * radiation exposure within the past 5 years * vitamin d deficiency is not an exclusion criteria as this is highly prevalent in the adult population under investigation as well as in patients with gaucher disease. (9, 10) * subjects previously diagnosed with gaucher disease
efficacy and safety of combination grazoprevir (mk-5172)/elbasvir (mk-8742) versus sofosbuvir + pegylated interferon + ribavirin in hepatitis c virus genotype 1, 4 or 6 infection (mk-5172-077)

Conditions: Hepatitis C

Summary: this is a study comparing grazoprevir (mk-5172) plus elbasvir (mk-8742) treatment with sofosbuvir (sof) plus pegylated interferon plus ribavirin (rbv) \[pr\] treatment in treatment-naïve and prior pr treatment failure participants with chronic hepatitis c virus (hcv) genotype (gt)1, gt4, or gt6 infection. the primary objectives are to compare efficacy (assessed by the percentage of participants achieving sustained virologic response 12 weeks after ending study treatment \[svr12\]) and safety between the grazoprevir plus elbasvir treatment arm and the sof plus pr treatment arm. the primary hypothesis is that the percentage of participants achieving svr12 in the grazoprevir plus elbasvir treatment arm is non-inferior to that in the sof plus pr treatment arm.


Eligibility criteria:
inclusion criteria: * weigh ≥40 kg and ≤125 kg * documented chronic hcv gt1, gt4, or gt6 infection * cirrhosis/absence of cirrhosis defined by liver biopsy, fibroscan, or fibrosure® * either treatment naïve or pr null responder, pr partial responder, or pr prior relapser * participant and partner both agree to use at least use at least 2 effective methods of contraception from at least 2 weeks prior to day 1 and continue until up to 6 months after last dose of study drug, or longer if dictated by local regulations exclusion criteria: * has evidence of decompensated liver disease * is coinfected with hepatitis b virus (e.g. hepatitis b surface antigen positive) or human immunodeficiency virus * history of malignancy ≤5 years prior to signing informed consent, or is under evaluation for other active or suspected malignancy * has cirrhosis and liver imaging within 6 months of day 1 showing evidence of hepatocellular carcinoma (hcc) or is under evaluation for hcc * has any of the following conditions: immunologically-mediated disease, organ transplants other than cornea and hair, poor venous access that precludes routine peripheral blood sampling, history of gastric surgery or malabsorption disorders, or any medical condition requiring, or likely to require, chronic systemic administration of corticosteroids during the course of the trial, history of chronic hepatitis not caused by hcv
study of statin as neo-adjuvant therapy in postmenopausal breast cancer

Conditions: Breast Cancer; Postmenopausal

Summary: the purpose of this study is to monitor: * tumor biological alterations following two weeks of neo-adjuvant statin therapy. * effects of statins on tumor proliferation. * functional studies on the mevalonate pathway.

blood samples and three core biopsies are taken after diagnosis. treatment with atorvastatin at a daily dosis of 80 mg is initiated 14 days before planned surgery. translational research will be performed from the core biopsy and blood samples taken before surgery and from the specimen from surgery.

Eligibility criteria:
inclusion criteria: * women with primary breast cancer who are candidates for radical surgery. * breast tumours clinically ≥ 15 mm, nx, m0. * breast tumours identified on mammography and verified on fine needle aspiration. * age \> 18 years. * performance status of ecog ≤ 1. * laboratory requirements at the day of diagnosis (t1-):prior to inclusion a normal renal (serum creatinine) and hepatic (transaminases) function (within normal limits) estimated in blood samples is required. * prior to patient registration, written informed consent must be given according to ich/gcp, and national/local regulations. * negative pregnancy test for pre menopausal women before inclusion in the trial exclusion criteria: * ongoing cholesterol lowering therapy (statins, fibrates, ezetimibe). * prior breast cancer treatment. * current hrt. * known liver disease. * history of hemorrhagic stroke. * psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; these conditions will be discussed with the patient before registration in the trial. * history of allergic reactions attributed to compounds of similar chemical or biological composition to atorvastatin.

Keywords: breast cancer postmenopausal neo-adjuvant tumor proliferation statin atorvastatin ki67 translational research cell cycle regulators gene expression genomic profiling apoptosis window-of-opportunity
study to evaluate long term immunogenicity up to 10 years after the first booster immunization with tick borne encephalitis vaccine in adults who received 1 of 3 different primary vaccination schedules

Conditions: Tick Borne Encephalitis; Virus Diseases

Summary: the aim of this study is to investigate the immunogenicity response in adults up to 10 years after one booster dose. data collected from this study will allow for greater information to prescribers who administer tbe vaccine, so that they can appropriately time the administration of booster vaccinations to individuals who received different vaccination schedules and who live in tick borne encephalitis endemic regions.


Eligibility criteria:
inclusion criteria: * subjects who have completed prior study - v48p7e1. exclusion criteria: * subjects whose antibody responses to booster vaccine received in the parent study fell below protective levels, subjects who have been exposed to tbe or flavivirus vaccine, subjects with immunosuppression.

Keywords: long term immunogenicity study