Kornimate/medical-research-clean huggingface dataset:
safety and efficacy study of omalizumab to treat allergic asthma

Conditions: Allergic Asthma

Summary: the primary purpose is to evaluate the safety and efficacy of recombinant humanized anti-ige monoclonal antibody injection in patients with allergic asthma.

omalizumab will be given as add-on treatment to budesonide inhaled powder in patients with moderate or severe allergic asthma(ige\>=60iu/ml), who demonstrate inadequate asthma symptom control. response to omalizumab will be assessed by the overall improvement in control of asthma. omalizumab is a recombinant humanized monoclonal antibody that selectively binds to human immunoglobulin e(ige). the antibody has a molecular weight of approximately 150 kilodaltons and produced by chinese hamster ovary cell. omalizumab inhibits the binding of ige to the high-affinity ige receptor on the surface of mast cells and basophils. reduction in surface-bound ige on cells limits the degree of release of mediators of the allergic response.

Eligibility criteria:
inclusion criteria: * male or female aged 15\~65 years * written informed consent provided * total serum ige \>=60iu/ml * duration of allergic asthma \>= 1 year according to gina(2008) * poor response to moderate to high dose inhaled corticosteroid (400ug/day\~800ug/day) \>= 4 weeks * agreed to be not pregnant, contraception during study and later 6 months. exclusion criteria: patients who met the below criteria were excluded: * be regular smokers(\>10 cigarettes per day and for at least 2 years) * patients who are currently pregnant or nursing or intend to become pregnant over the course of the study or later 6 months * copd, according to the guideline of chinese society of respiratory diseases * an active lung disease other than allergic asthma * patients with significant underlying medical conditions * allergic to immunoglobin or any formulation ingredient of the product * patients with diabetes or uncontrolled hypertension(systolic blood pressure\>160mmhg or diastolic blood pressure\>95mmhg) * hiv positivity or cancer patient * prior exposure to xolair

Keywords: omalizumab ige asthma
aldh2 mutation in taiwanese head and neck cancer

Conditions: Dermatitis; Mucositis

Summary: the purpose of this study is to evaluate the effect of aldh2 mutation in radiation associating dermatitis or mucositis in head and neck cancer patients who accept chemoradiation therapy

* one-site audit. the enrolled subject is confirmed by pis ◦◦source data is compared to external data sources medical records, either paper or electronic case report forms. * nci ctcae v5.0 for ae records * patient recruitment according to inclusion criteria: 1. newly diagnosed locally head and neck squamous cell carcinoma; 2. apply for primary chemoradiation or adjuvant chemoradiation; 3. signed informed consent * sample size assessment: 60 subjects will be included in one year for total 120 subjects * missing data to address situations where variables are reported as missing, unavailable, "non-reported," uninterpretable, or considered missing because of data inconsistency or out-of-range results * fisher's exact test is for category comparison. kaplan-meier analysis is for survival analysis. ae grades will be analyzed according to nci guideline. two-side p \< 0.05 is suggested significant.

Eligibility criteria:
inclusion criteria: * age \>20, \<70 * newly diagnosed head and neck squamous cell carcinoma * tissue proved * signed informed consent * suitable for chemoradiation exclusion criteria: * uncontrolled underlying diseases * allergy to chemotherapy * uncontrolled skin diseases or mucosa diseases * previously radiation therapy over head and neck * combined with other cancer currently

Keywords: head and neck cancer asian aldh2
metformin in diabetic patients undergoing coronary angiography

Conditions: Diabetes Mellitus; Coronary Artery Disease; Lactic Acidosis With Diabetes Mellitus; Contrast-induced Nephropathy; Metformin Associated Lactic Acidosis

Summary: the present study aims to evaluate the strict application of the 2018 european society of cardiology guidelines on myocardial revascularization, that recommends to check renal function if patients have taken metformin immediately before angiography and withhold metformin if renal function deteriorates. the aim of this study is to assess the safety of metformin in diabetic patients undergoing coronary angiography in terms of risk of lactic acidosis and to individuate eventual predictors of augmented lactate after coronary angiography.

the study is designed as an open-label (both physician and participant know that metformin will not be discontinued before pci and in the following 48 hours), prospective, single arm study. in our historical cohort of diabetic patients taking metformin, we observed a mean value of lactate of 1.2+0.7 mmol/l. a total of 150 patients will be enrolled. patients with any deviations from the study protocol will be enrolled in a parallel observational registry. the study consists of a screening phase, a 30-day observational phase, and an end-of-follow-up visit or phone interview. the total duration of participation in the study for each participant is approximately 30 days.

Eligibility criteria:
inclusion criteria: * diabetic patients treated with metformin undergoing coronary angiography. exclusion criteria: * known coronary anatomy with planned complex percutaneous coronary intervention with high probability of large amount of contrast use (3.7 \* estimated glomerular filtration rate; e.g.: 167 ml in a patients with an egfr of 45 ml/min/1.73m2). * moderate to severe impairment of renal function (egfr\<45 ml/min). * moderate to severe impairment of liver function (child-pugh class b or c). * severely impaired left ventricular ejection fraction (lvef \<35%). * patients undergoing primary percutaneous coronary intervention (i.e., patients presenting with st elevation myocardial infarction). * severe to very severe chronic obstructive pulmonary disease (gold class 3 to 4). * patients scheduled for cardiac surgery in the following 5 days. * inability to provide informed consent.

Keywords: metformin coronary angiography diabetes mellitus lactic acidosis
il13rα2 car-t for patients with r/r glioma

Conditions: Glioma

Summary: this is a dose exploration clinical trial to assess the safety and feasibility of the il13ra2-targeted car-t in glioma.

interleukin 13 receptor subunit alpha-2 (il13ra2a) is a high-affinity membrane receptor of the anti-inflammatory th2 cytokine il13, which is overexpressed in glioma and correlated with poor prognosis. chimeric antigen receptor (car) t cell therapy is a promising treatment approach for many malignancies. il13ra2-targeted car-t cells are under investigation in several clinical trials in primary cns malignancies. the investigators now designed a new structure car targeted il13ra2, and initiated a single arm, open, dose exploration clinical trial to evaluate the safety, tolerability, clinical efficacy, and pharmacokinetic characteristics of il13rα2 car-t for patients with glioma. this clinical trial will enroll 12-30 cases of patients with il13α2-positive recurrent or refractory who grade 4 glioma (r/r who4 glioma), aiming to find the maximum tolerable dose (mtd), the recommended phase 2 dose (rp2d) and preliminary efficacy of the new structure il13ra2 car-t.

Eligibility criteria:
inclusion criteria: 1. male or female aged 18-75 years (including 18 and 75 years old). 2. karnofsky scale score (kps)≥50. 3. subjects with who grade 4 gliomas who have relapsed or progressed during or after standard treatments such as surgery, radiotherapy, and chemotherapy. 4. tumor with il13rα2 positive expression. 5. availability in collecting peripheral blood mononuclear cells (pbmcs). 6. adequate laboratory values and adequate organ function. 7. patients with childbearing/fathering potential must agree to use highly effective contraception. exclusion criteria: 1. pregnant or breastfeeding females. 2. contraindication to bevacizumab. 3. within 5 days prior to the infusion of car-t cells, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids (not including inhaled corticosteroid). 4. comorbid with other uncontrolled malignancy. 5. active immunodeficiency virus (hiv) or hepatitis b virus or hepatitis c virus or tuberculosis infection. 6. autoimmune diseases. 7. severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes. 8. subjects who have previously received cell therapy (such as tcr-t, car-t, til, etc.). 9. subjects with other conditions that would interfere trial participation at the investigator's discretion.

Keywords: r/r who4 glioma
walk with me: a mobile application to improve walking in persons with ms

Conditions: Multiple Sclerosis

Summary: during 10 weeks the subjects will use a mobile application (walk with me). the aim of this study is to investigate the usability of the mobile application, as well as investigating if the mobile application effects walking.


Eligibility criteria:
inclusion criteria: * confirmed diagnosis according to the mcdonald criteria * able to walk independently or with unilateral support for 10 minutes exclusion criteria: * exacerbation or relapse within last 3 months before study * other medical condition interfering with walking ability (e.g. cardiac or respiratory diseases, arthritis and fibromyalgia, stroke, parkinson).
eswt for shoulder pain in patients with brain damage

Conditions: Brain Damage, Hypoxic; Stroke; Brain Tumor; ICH

Summary: this study aimed to investigate the efficacy and safety of extracorporeal shockwave therapy (eswt) for upper extremity pain related to spasticity in patients with spinal cord injury.

6 times of eswt (3,000 pulses per time, low energy under 0.3 mj/mm\^2, tolerable range) on subscapularis and lesser and greater tuberlces of humerus to reduce pain in patients with brain damage

Eligibility criteria:
inclusion criteria: * brain damaged patient confirmed in the brain image * 1 month after brain damage * pain in hemiplegic shoulder areas more than 4 points on the numerical scale (nrs) * cognitive functions that can clearly point out nrs with more than 15 points in the mini mental state examination (mmse) * age: 20 and older * person who has agreed in writing to decide his or her participation and comply with the precautions exclusion criteria: * pain due to trauma * injection treatments two weeks before participating in the study * severe coagulopathy (excluding antiplatelet use) * impaired cognition

Keywords: extracorporeal shockwave therapy brain damage pain
emotion recognition training in antisocial violent offenders with psychopathic traits

Conditions: Psychopathy; Violent Aggressive Behavior; Emotional Problem

Summary: impaired recognition of affective facial expressions has been conclusively linked to antisocial and psychopathy. however, little is known about the modifiability of this deficit. this study aims to investigate whether and under which circumstances the proposed perceptual insensitivity can be addressed with a brief implicit training approach.


Eligibility criteria:
inclusion criteria: * confirmed aspd diagnosis * pcl-score available * arrested for committing violent crimes exclusion criteria: * insufficient knowledge of the german language * diagnosed with schizophrenia * substance abuse * neurological disease (e.g. epilepsy) * mental retardation
neuromark registry study

Conditions: Chronic Rhinitis

Summary: the neuromark registry study is a prospective, multicenter, single-arm, post-market, interventional registry study to collect real-world evidence of the neuromark system in subjects with chronic rhinitis.


Eligibility criteria:
inclusion criteria: subject must: 1. be ≥18 years of age. 2. be scheduled to receive treatment with the commercially available neuromark system consistent with the device's indications for use. 3. have moderate to severe symptoms of running nose (individual rtnss symptom rating of 2 or 3), mild to severe symptoms of nasal congestion (individual rtnss symptom rating of 1, 2, or 3), and a minimum total score of 5 (out of 12) at screening. 4. be willing and able to provide consent and comply with all study elements, as indicated by written informed consent. exclusion criteria: subjects must not: 1. have a history of chronic epistaxis or experienced a significant epistaxis event (defined as epistaxis requiring medical intervention) in the past 3 months.

Keywords: rhinitis
provoked craving assessment

Conditions: Smoking Dependence; Smoking

Summary: evaluation of the ability of a nicotine mini lozenge to provide early relief of craving for a cigarette in smokers


Eligibility criteria:
inclusion criteria: * current cigarette smokers who have smoked regularly, and smoke more than 20 cigarettes per day on a regular basis for at least a year; * good general health with (in the opinion of the investigator) no clinically significant and relevant abnormalities of medical history. exclusion criteria: * any disease that may interfere with the absorption, metabolism or excretion of the study product. * a medical condition that might jeopardise the safety of the subject or the validity of the study results. for example, recent myocardial infarction or cerebrovascular incident (within 12 weeks of the screening visit), phenylketonuria, unstable or worsening angina pectoris, prinzmetals angina or severe cardiac arrhythmia

Keywords: craving
a prospective, multi-center, single-arm study of the stomach, intestinal and pylorus sparing (sips) procedure

Conditions: Obesity

Summary: this study is a prospective, multi-center, single-arm study evaluating the sips procedure. subjects who meet the eligibility criteria will be considered for study participation and will be followed through 12 months.

sips is a single-anastomosis duodeno-intestinal switch procedure. preliminary data from sanchez-pernaute et al. (surg obes relat dis 2013;9:731) indicates that this procedure is safe, quick to perform, and offers good results for treatment of both morbid obesity and its metabolic comorbidities. covidientm plans to further investigate this procedure and has proposed a prospective clinical study to obtain data on subject outcomes through 12 months following the sips procedure.

Eligibility criteria:
inclusion criteria: * the subject must be 18-65 years of age * the subject must be willing and able to participate in the study procedures and to understand and sign the informed consent * the subject is under consideration for surgery for obesity or metabolic disease and elects to undergo a primary sips procedure * the subject has a bmi of 35-40 kg/m2 with at least 1 obesity-related comorbidity or a bmi of 40-60 kg/m2 exclusion criteria: * any female subject who is pregnant, or is actively breast-feeding * any subject who is considered to be part of a vulnerable population (e.g. prisoners or those with psychological concerns or those without sufficient mental capacity) * the procedure is an emergency procedure * the procedure is a revision/reoperation for the same indication * the subject is unable or unwilling to comply with the study requirements or follow-up schedule * the subject has conditions which, in the opinion of the investigator, will not be appropriate for the study (e.g. severe cardiovascular disease, history of gastrointestinal (gi) malignancy, history of upper gi surgery, open cholecystectomy, history of intestinal surgery, immunosuppression, or non-ambulatory) * the subject has an estimated life expectancy of less than 6 months * the subject has participated in an investigational drug or device research study within 30 days of enrollment
clinical study of pain reduction by peri-arthroscopic prp application in knee degeneration

Conditions: Knee Osteoarthritis; Cartilage Damage; Meniscal Tear

Summary: the purpose of this study is to investigate reduction of pain, gain of function and improvement of life quality by intraoperative applied platelet- rich- plasma ( prp ) during knee arthroscopy for degeneration and osteoarthritis oa by conducting a randomized- controlled, double-blinded trial ( rct ) including 58 patients with a follow up of 12 months and pain, assessed by visual- analogue scale (vas) after 6 months as primary endpoint.


Eligibility criteria:
inclusion criteria: * degenerative knee pain * age: \> 18 years * informed consent * none to moderate comorbidity * arthroscopy under general anaesthesia indicated exclusion criteria: * trauma of the knee within the last 6 weeks before surgery * circumscribed cartilage lesion with possibility of repair microfracture or autologous chondrocyte transplantation - procedures * contraindications against prp. application * malignancies * severe comorbidities * age \<18 years * physically or mentally not able to provide informed consent * severe knee instability * corticosteroid injections within the last 6 weeks before surgery

Keywords: platelet rich plasma autologous conditioned plasma outerbridge
air leakage under continuous positive airway pressure

Conditions: Obstructive Sleep Apnea Syndrome

Summary: the software embedded in recent continuous positive pressure devices enables the analysis of the level of leakage that occurs during treatment around the mask or from the mouth. however, there is no clear threshold defining when it would be appropriate to implement means for correcting these leaks. in addition, the calculation methods used to detect/measure leaks and the terminology used vary according to the manufacturers of continuous pressure devices, which also complicates the clinical interpretation of the leakage reports provided by the various devices. in daily practice, when a patient complains of unintentional leakage, technicians adjust the mask, replace the nasal-mask by an oro-nasal mask or install a chinstrap. nevertheless, those strategies are not always effective in reducing leakage or patient's complaints. a better understanding of the mechanisms beyond leak appearance for a given patient could lead to individualised leak-treatment solutions. pressure level, mandibular behaviour, respiratory effort, sleep position or sleep stages may contribute to leak emergence. a recent exploratory study has proposed a genuine analysis method of determining factors of unintentional-leaks using polysomnographic recordings in osa patients treated with automatic continuous positive airway pressure (auto-cpap). based on the same methodology, the nomics company (liège, belgium) has developed a polygraphic device (brizzy®) recording unintentional leakage during auto-cpap treatment and providing an etiological analysis of unintentional-leaks via a software named apios. due to the innovative nature of the analysis, it appears necessary to validate it onto a population of osa patients treated with auto-cpap. also, to our knowledge, there is no descriptive data of the distribution of the determinants of unintentional leaks in such a population. from this perspective, the investigators aim to retrospectively analyse some polygraphic recordings that have been performed with the brizzy® on osa patients treated with auto-cpap. the primary objective of this study is to identify and describe the determinants of unintentional leaks for a population of patients with osa and treated with an auto-cpap device

the secondary objectives are: 1. to evaluate the concordance of the determinants of leaks according to different leak thresholds (0 l/min ; 5l/min ; 10l/min : 20l/min). 2. to describe any technical problems that arise in relation to the analysis of leaks in the study population.

Eligibility criteria:
inclusion criteria: * sleep recordings from patients with osa treated via auto-cpap and monitored with brizzy® device (including measures of non-intentional leaks) between june 1st and december 31th, 2017. exclusion criteria: * the patient opposes the usage of his/her data * minors or adults under any kind of guardianship * fixed pressure * bilevel positive airway pressure devices * adaptive servo-ventilation

Keywords: cpap masks unintentional leak leakage
a study of positive emotions with long covid-19

Conditions: Post-Acute COVID-19 Syndrome

Summary: this study is testing a new brief mindfulness practice for people suffering from long covid-19 symptoms. people suffering from long covid are particularly vulnerable to negative emotions, as they must also cope with the long-term uncertainty of physical and psychological stress beyond the acute infection. the goal of the study is to measure the ability of a brief mindfulness practice to promote a sense of well-being in people suffering from long covid.

this is a pilot randomized waitlist-controlled clinical trial (rct) testing a new brief self-care intervention for people suffering from post-acute sequelae sars-cov-2 infection (pasc). the overarching goal of this study is to establish the feasibility and early efficacy of microdosing mindfulness as a self-care intervention. the purpose of the intervention is to promote a sense of well-being among pasc patients who currently have limited access to other proven self-care modalities. our research question is whether our newly developed training can assist pasc patients to self-microdose mindfulness (5-15 seconds activities in everyday life) and improve on perceived metrics of well-being (primary outcome). our hypothesis is that self-microdosing mindfulness will evoke positive emotions that can improve well-being on patients suffering of pasc-related symptoms beyond 3 months post covid-19 infection. if effective, an increased frequency of the mindfulness activity will then help buffer negative emotions (e.g., anger, loneliness, etc.) experienced during the pandemic and associated with ongoing stress and/or somatic symptoms.

Eligibility criteria:
inclusion criteria: * able to participate in online zoom sessions and complete online surveys for 3 months * english speakers * had a mild to moderate in severity covid-19 infection \> 3 months ago, feeling unwell, and are still experiencing in the present at least one pasc-related symptoms: * coughing or feeling short of breath * loss of smell or change in taste * recurrent fever * body aches, headaches, chest pain, or stomach pain * brain fog (feeling like you can't think clearly) * having trouble sleeping * feeling very tired * mood changes exclusion criteria: * adults that were admitted to an intensive care unit or placed on a respirator, had invasive heart (heart catheterization) or lung tests (bronchoscopy) performed. * prisoners

Keywords: mindfulness