Kornimate/medical-research-clean huggingface dataset:
automatic dispersion tagging function preliminary evaluation

Conditions: Atrial Fibrillation; Atrial Tachycardia; Atrial Arrhythmia

Summary: interventional, prospective, non-randomized, single-center, non-controlled clinical investigation as part of the premarket clinical evaluation of vx1+ medical device, aiming to verify that vx1+ in bidirectional configuration with auto-tagging function is both ergonomic and reliable for dispersed electrograms detection and automatic tagging on 3d-map in real-time.

ablation of atrial fibrillation (af) and atrial tachycardia (at) is typically performed in predetermined anatomic regions of the left atrium (pulmonary veins isolation) and may be supplemented by a tailored ablation approach in order to identify areas of interest specific to the patient. the vx1+ medical device is intended to assist operators in the manual or automatic real-time annotation of 3d electroanatomical maps of the heart for the presence of multipolar intra-cardiac atrial electrograms exhibiting spatio-temporal dispersion during ablation procedures. this study will specifically allow to evaluate the peroperative performance of vx1+ automatic tagging function in bi-directional configuration with a compatible 3d mapping system.

Eligibility criteria:
inclusion criteria: * patient aged 18 years or older. * patient candidate for catheter ablation of atrial tachycardia, or paroxysmal or persistent atrial fibrillation, de novo or after one or several previous ablation procedures. * continuous anticoagulation for more than 4 weeks before ablation. * patient giving his signed consent form to participate in the clinical study. * patient affiliated to the french social security exclusion criteria: * contraindication to af/at catheter ablation. * major bleeding disorder. * contraindication to anticoagulation (heparin, warfarin or novel oral anticoagulants (noac)) or lack of anticoagulation for 4 weeks prior to the procedure. * presence of a left atrium (la) thrombus on transesophageal echocardiography (tee) prior to the procedure. * patient who is or could potentially be pregnant. * person deprived of liberty or under guardianship. * patient's refusal to participate in the study.

Keywords: artificial intelligence cardiac ablation medical device software volta medical atrial arrhythmia
viral clearance, pk and tolerability of ensovibep in covid-19 patients

Conditions: Covid19

Summary: this study will investigate how ensovibep is distributed throughout the body, the viral clearance and the tolerability of ensovibep in patients with symptomatic covid-19 disease


Eligibility criteria:
inclusion criteria: * men or non-pregnant women, between 18 and 70 years on the day of inclusion. * presence of one or more mild or moderate covid-19 symptoms: fever, cough, sore throat, malaise, fatigue, headache, muscle pain, gastrointestinal symptoms, or shortness of breath with exertion. * positive test for sars-cov-2 in upper respiratory swab on the day of dosing (rapid antigen test). exclusion criteria: * requiring hospitalization at time of screening, or at time of study drug administration. * oxygen saturation (spo2) ≤ 93 percent (%) on room air at sea level, respiratory rate ≥ 30 per minute, or heart rate ≥125 per minute. * any serious concomitant systemic disease, condition, or disorder that, in the opinion of the investigator, should preclude participation in this study. * any co-morbidity requiring hospitalization or surgery within \<7 days, or that is considered life-threatening within 29 days. * a patient reported history (prior to the current episode) of a positive sars-cov-2 serology test or a history of pcr confirmed sars-cov-2 infection. * prior or concurrent use of sars-cov-2 antiviral medication, including convalescent serum or anti-viral antibodies. * concurrent enrollment in any other type of medical research for improving covid-19 outcomes or that is judged by the investigator not to be scientifically or medically compatible with this study. * women that are currently breast feeding, pregnant, or plan to get pregnant during the duration of the trial. * severe immunocompromised status (primary immunodeficiency, supraphysiological dose of systemic corticosteroids, transplant patients, known untreated hiv and cd4 t-cells \<200/microliter) or use of any immunosuppressants that, in the opinion of the investigator, should preclude participation in this study. * subjects at high risk for of covid-19 related complications or mortality

Keywords: sars-cov-2 corona darpin
pd-1 knockout engineered t cells for metastatic non-small cell lung cancer

Conditions: Metastatic Non-small Cell Lung Cancer

Summary: this study will evaluate the safety of pd-1 knockout engineered t cells in treating metastatic non-small cell lung cancer. blood samples will also be collected for research purposes.

this is a dose-escalation study of ex-vivo knocked-out, expanded, and selected pd-1 knockout-t cells from autologous origin. patients are assigned to 1 of 3 treatment groups to determine the maximal tolerant dose. after the lower number of cycles are considered tolerant, an arm of the next higher number of cycles will be open to next patients. biomarkers and immunological markers are collected and analyzed as well.

Eligibility criteria:
inclusion criteria: * pathologically verified stage iv non-small cell lung cancer with measurable lesions (on ct: longest diameter of tumoral lesion \>=10 mm, shorted diameter of lymph node \>=15 mm; measurable lesions should not have been irradiated) * progressed after all standard treatment * performance score: 0-1 * expected life span: \>= 6 months * toxicities from prior treatment has resolved. washout period is 4 weeks for chemotherapy, and 2 weeks for targeted therapy * major organs function normally * women at pregnant ages should be under contraception * willing and able to provide informed consent exclusion criteria: * pathology is mixed type * emergent treatment of tumor emergency is needed * poor vasculature * coagulopathy, or ongoing thrombolytics and/or anticoagulation * blood-borne infectious disease, e.g. hepatitis b * history of mandatory custody because of psychosis or other psychological disease inappropriate for treatment deemed by treating physician * with other immune diseases, or chronic use of immunosuppressants or steroids * compliance cannot be expected * other conditions requiring exclusion deemed by physician

Keywords: lung cancer immune checkpoint pd-1 crispr autologous cell infusion
effects of ecopipam or placebo in adults with stuttering (speak freely)

Conditions: Childhood-Onset Fluency Disorder (Stuttering)

Summary: this is a multicenter, randomized, double-blind, placebo-controlled, parallel-group, phase 2 exploratory study in adult subjects with childhood onset fluency disorder.

at the baseline visit, eligible subjects will be randomized 1:1 to receive either a target steady-state dose of ecopipam hcl \~2 mg/kg/day or matching placebo for a 12-week treatment period consisting of a 4-week titration phase followed by an 8-week maintenance phase. subjects will return to the clinic at 4, 8, and 12 weeks after randomization and follow-up visits 7 and 14 days after completing the treatment period or early discontinuation. efficacy assessments will be conducted at weeks 4, 8, and 12 and safety assessments will be conducted at all visits. subjects will have adverse events and other safety parameters assessed by phone or video conference at weeks 2, 6 and 10 and 30 days after the last study drug administration. signs or symptoms of withdrawal, abuse, and dependence will be monitored throughout the study. at the end of the treatment period or early discontinuation, subjects will taper study drug by 25 mg/day until off study drug, for up to 1 week.

Eligibility criteria:
inclusion criteria: * able to read and write in english and provide informed consent * 18 years or older of age at screening * weighs \>= 45 kg (\~99 lbs) * satisfies dsm-5 criteria for childhood onset fluency disorder * history of stuttering for \>=2 years with onset consistent to developmental in nature * must meet an allowed severity of stuttering at screening and baseline, scored by a central rater * completed an adequate course of speech therapy * has a qualifying ios or android smartphone * must discontinue all medications used to treat stuttering for at least 14 days prior to screening * sexually active females of child bearing potential must be using effective contraception during and 30 days after participation * sexually active males must use a double barrier method of contraception during and 30 days after participation exclusion criteria: * stuttering is related to a known neurological cause * initiation of new behavioral therapies for stuttering within 10 weeks prior to baseline * unstable medical illness or clinically significant abnormalities on screening tests/exams * at a significant risk of committing suicide * are pregnant or lactating * positive urine drug screen * lifetime history of major depressive episode * history of seizures * have been previously treated with ecopipam * unstable use of medications prior to screening * use of prohibited medications or need for medications which would have unfavorable interactions with ecopipam * not suitable for study in the opinion of the principle investigator

Keywords: stuttering communication disorders
safety and tolerability study of azd2171 in combination with azd0530 in patients with advanced solid tumours

Conditions: Neoplasms

Summary: the purpose of the study is to determine if the maximum tolerated doses of azd2171, in combination with azd0530, in treating patients with advanced solid tumours are safe, tolerable and efficacious.


Eligibility criteria:
inclusion criteria: * written consent * cancer diagnosis \& stage * patients for whom no standard therapy exists * world health organization (who) performance status 0-2 * one or more measurable lesions exclusion criteria: * prostate cancer * untreated unstable brain or meningeal metastases * specific laboratory ranges * pregnant or breast-feeding women * any evidence of severe or uncontrolled diseases * participation in other trials within 30 days

Keywords: cancer tumour advanced solid tumour lung cancer breast cancer cholangiocarcinoma colon cancer gastric cancer choriocarcinoma liver cancer myeloma ovarian cancer pancreatic cancer peritoneal cancer
effectiveness of influenza vaccine reminder systems

Conditions: Asthma; Chronic Obstructive Pulmonary Disease

Summary: influenza disease causes significant morbidity and mortality in the unites states each year. although influenza can cause morbidity in otherwise healthy individuals, adults with chronic lung disease have significantly increased rates of hospitalization from influenza-related illnesses compared to healthy adults. influenza vaccination is the primary means of preventing influenza disease. annual influenza vaccination is recommended for all individuals 6 months of age and older in the united states. influenza vaccination rates are sub-optimal, however. patient reminder/recall has been shown, in multiple studies across a variety of age groups and health conditions, to increase immunization rates. however, the effectiveness and cost-effectiveness of different types of reminder/recall has not been well-studied, particularly in adults. in the fall of 2012, the population and prevention services (pps) department at kaiser permanente colorado (kpco) is using 3 different reminder strategies for influenza vaccination among adults with asthma and chronic obstructive pulmonary disease (copd). the objective of this study is to provide a rigorous evaluation of which strategy is more effective and more cost-effective, to promote influenza vaccination.

at kpco, postcards are typically sent to members each fall, to remind members to receive their annual influenza vaccine. at kpco, interactive voice response (ivr) systems have been utilized for a number of prevention reminders, but have not in the past been used for influenza vaccination reminders. for the 2012-2013 influenza season, the pps department is going to send three different types of reminders to their adult patients with certain chronic lung diseases (specifically, adults with asthma and copd): postcards only; ivr reminders only; postcards plus ivr reminders. this study seeks to evaluate the effectiveness, and cost-effectiveness, of an already-finalized operational plan for influenza reminders.

Eligibility criteria:
inclusion criteria: * age 19 to 64 years * enrolled in kaiser permanente colorado health plan * diagnosis of asthma and/or chronic obstructive pulmonary disease exclusion criteria: * subjects living in households with other individuals in high-risk categories for influenza morbidity

Keywords: influenza, human immunization
the effect of instrument assisted soft tissue mobilization in female patients with myofascial pain syndrome

Conditions: Myofascial Pain; Instrument Assisted Soft Tissue Mobilization

Summary: the primer aim of this study is to demonstrate the effecti of instrument assisted soft tissue mobilization on pain, functionality, quality of life and depression in the treatment of female patients with myofascial pain syndrome due to active trigger points in the upper trapezius muscles

myofascial pain syndrome (mas); it is a non-articular, non-inflammatory regional musculoskeletal pain syndrome characterized by myofascial trigger points located at muscle, fascia or tendon insertion sites and the spread of pain to reference areas by palpation of these points. h the effectiveness of massage therapy in mas is known. in this study, investigators will apply instrument assisted deep tissue mobilization (graston massage). instrument-assisted soft tissue mobilization massage, which is a type of massage, will be applied by a physiotherapist who has a certificate on this subject and takes part as an assistant researcher in our study. soft tissue mobilization is a unique soft tissue mobilization combined with active mobility and stretching exercises already prescribed for patients with musculoskeletal injuries. the various sizes and beveled edges of the stainless steel instruments allow physiotherapists to tailor treatment to different muscle structures facing myofascial constraints. localized increases in blood flow and soft tissue realignment lead to muscle function, increased normal joint motion, and decreased pain. it has been investigated in the literature for many different diseases (trigger finger, nonspecific low back pain, myofascial pain syndrome) and found to be effective.cf

Eligibility criteria:
inclusion criteria: 1. being woman and between the ages of 18-45 2. not to be in menopause 3. pain in the upper trapezius area 4. detection of a taut band in the upper trapezius region on examination 5. at least one active trigger point in the tension band in the upper trapezius region on examination 6. the pain caused by the compression of the trigger point is the pain that the patient complains about 7. painful restriction of cervical lateral flexion motion during stretching 8. pain 4 or more according to nrs exclusion criteria: 1. major surgery or trauma to the musculoskeletal system, especially the spine and upper extremities 2.history of any operation related to the head and neck region 3. neuromuscular disease 4. history of rheumatic disease, malgnite in the active period 4. cervical discopathy, cervical spondylosis, pathologies related to the shoulder joint and surrounding soft tissues, scoliosis, kyphosis, leg length difference, polio sequelae, developmental hip dysplasia 5. psychiatric disease (beck depression inventory score of 30 and above) 6.obese (bmi≥30 kg/m2) -

Keywords: miyofascial pain instrument assisted soft tissue mobilization quality of life
study on the improvement of microcirculation in patients with sepsis by vitamin b6, vitamin b12 and vitamin c

Conditions: Septic Shock

Summary: sepsis is a kind of disease with high morbidity and mortality in icu. at present, there is no specific treatment, and its pathogenesis is mainly excessive oxidative stress. anti-inflammatory, antioxidant and immune-regulating drugs may produce better therapeutic effects, while vitamin b6, vitamin b12 and vitamin c have anti-inflammatory, antioxidant and immune-regulating effects. the purpose of this study was to investigate whether vitamin b6, vitamin b12 combined with vitamin c can improve the microcirculation and organ dysfunction in patients with sepsis, and improve the survival rate of patients with sepsis. the study included 296 patients who met the inclusion criteria. after randomization, the experimental group was given intravenous vitamin b6 300mg qd in addition to the basic treatment of sepsis vitamin b12 0.5mg q6h, vitamin c 50mg/kg q6h for 4 days. control group 1 was given vitamin b6 300mg qd and vitamin b12 0.5mg q6h intravenously for 4 days. control group 2 was injected with vitamin c 50mg/kg q6h intravenously for 4 days. control group 3: the same dose of placebo (0.9% sodium chloride solution) was administered for 4 days. after medication, sublingual microcirculation image and radial artery resistance index of snus pit were detected and recorded according to the time required by the study protocol. the duration of use of pressor drugs, ventilator days, icu stay, 28-day mortality, capillary refill time, changes in sofa score and apacheii score on day 3 and day 7 compared with baseline values at randomization, daily veno-arterial carbon dioxide differential pressure (gap) and central venous oxygen saturation were recorded. after the end of the experiment, statistical analysis of the data was carried out to further explore the test results


Eligibility criteria:
inclusion criteria: 1. age ≥18 and \< 85 years old 2. admitted to icu 3. diagnosis of patients with sepsis 3.0 (diagnostic criteria) 4, sofa score is 2-13 points 5. obtain the informed consent of the subject or his family exclusion criteria: 1. patients have absolute contraindications such as vitamin allergy 2. patients with a history of gout 3. death is expected within 24 hours 4. pregnant women 5. use hydroprednisone or other equivalent dose hormones \> 200mg/d within 24 hours 6. without the informed consent of the patient or his/her representative 7. patients with a history of scleroderma 8. patients with a history of vasculitis 9. patients with oral mucosal diseases 10. patients with severe difficulty in opening their mouth and unable to detect sublingual microcirculation
evaluation of akr1b10 as a new marker for interventional therapy of hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: primary liver cancer is currently the fourth most common malignant tumor and the second leading cause of tumor mortality in china, posing a serious threat to the lives and health of the chinese people . at present, non-surgical treatment methods are often used, such as radiofrequency ablation (rfa), transcatheter arterial chemoembolization (tace), radiation therapy, and systemic anti-tumor therapy. however, whether it is surgical treatment or non-surgical treatment, commonly used liver cancer related biomarkers in clinical practice during the evaluation of treatment efficacy or regular follow-up of patients include afp, afp-l3%, dcp, etc. , but there are no reports on whether akr1b10 can be used for the efficacy evaluation of these treatment methods.therefore, this project aims to explore the clinical value of akr1b10 in evaluating the efficacy of liver cancer treatment.

patients with hepatocellular carcinoma (hcc) treated with transarterial chemoembolisation (tace) are enrolled in this clinical trial. in the early stage, a research team detected the levels of akr1b10 in serum samples from 477 normal individuals, 107 benign liver tumors, 32 patients with chronic hepatitis b, 78 patients with liver cirrhosis, and 482 patients with liver cancer, and evaluated its early diagnostic value in liver cancer. it was found that akr1b10 protein, as a serum marker for liver cancer, had significantly better performance than afp, mainly reflected in three aspects: first, it is more sensitive, the normal background level (reference range) of akr1b10 is significantly lower than afp, which means that during clinical testing, changes in serum concentration are more pronounced, making it easier to identify asymptomatic early liver cancer patients; secondly, it is more specific and has a higher detection rate for liver cancer, with lower false positive and false negative rates. in addition, more than 70% of liver cancer patients who test negative for afp will be tested positive for akr1b10, resulting in lower rates of missed diagnosis and misdiagnosis; thirdly, the time to reflect changes in the condition is 6-7 times faster than afp. the half-life of akr1b10 is 23 hours, while afp has a half-life of 6-7 days.this project mainly aims to explore the clinical value of akr1b10 in evaluating the efficacy of liver cancer treatment.

Eligibility criteria:
inclusion criteria: * age between 18 and 80 * diagnosis of hcc according the aasld criteria * tace is planned * resection is impossible * no significant underlying medical illness affecting patient's survival * patients available for regular follow-up according to the study protocol exclusion criteria: * previous history of other tumors; * combined with other tumors; * received external treatment before admission; * patients who have received blood transfusions within one month; * the patient was unable to participate in this study for other reasons.

Keywords: akr1b10