Kornimate/medical-research-clean huggingface dataset:
a study of local envafolimab injection combined with chemotherapy in non-small cell lung cancer

Conditions: NSCLC

Summary: the aim of this single-arm, exploratory clinical study is to evaluate the safety and efficacy of local injection of envafolimab combined with chemotherapy in the first-line treatment of non-small cell lung cancer (nsclc) patients, and to observe the changes of immune cells in the local immune microenvironment before and after immunotherapy, in order to find new indicators for immunotherapy evaluation.

in this study, 16 patients with nsclc were enrolled to explore the clinical effect of chemotherapy combined with local injection of envafolimab. to determine whether the treatment of metastatic/recurrent nsclc with envafolimab is effective, and whether the treatment of envafolimab combined with chemotherapy can prolong the pfs\\os of patients with nsclc, and to screen for a more effective treatment mode for chinese nsclc patients.

Eligibility criteria:
inclusion criteria: * 1. the subjects volunteered to participate in the study, signed the informed consent form, and had good compliance; * 2. ecog≤2 ; * 3.life expectancy of ≥12 weeks； * 4.age ≥18 years; * 5. diagnosed by histological examination and/or cytology examination, and imaging evaluation (refer to recist 1.1) for advanced central nsclc; * 6. he had not received systemic chemotherapy previously. * 7.had at least one measurable tumor lesion according to recist v1.1；that is, in ct or mri detection, the longest diameter of a single lesion is ≥10mm, or the lymph node is pathologically enlarged, and the short diameter of a single lymph node on ct scan is ≥15mm； * 8.have adequate organ function。 exclusion criteria: * 1.this study was conducted five years prior to the initiation of treatment or concurrently with other malignant tumors. * 2. have family history of cancer. * 3.had previously undergone any form treatment, such as surgery, chemotherapy, radiation therapy, etc. * 4.only individuals experiencing grade 1 or higher unmitigated toxic effects (excluding alopecia and fatigue) resulting from previous therapies were eligible for enrollment; neurologic toxicity needed to return to grade 1 or lower or baseline before participation. * 5.subjects with severe and/or uncontrollable disease progression； * 6.human immunodeficiency virus (hiv) infection or known acquired immunodeficiency syndrome; * 7.pregnant or lactating women; * 8.other conditions considered unsuitable for this study by the investigator.
comparing cognitive behaviour therapy (cbt) with metacognitive therapy (mct) in the treatment of gad

Conditions: Generalized Anxiety Disorder

Summary: meta cognitive therapy (mct) has been introduced as a new specific treatment for generalised anxiety disorder. so far, no studies have examined cbt and mct in comparison with each other in a randomised controlled trial. sixty patients with a diagnosis of generalised anxiety disorder will be selected and randomised into three treatment conditions. the first group (n=20) will be treated with cbt, the second group (n=20) with mct, and the third condition is a waiting list control (n=20). the patients in both groups will have full treatment, in accordance to treatment manuals developed by the originators. patients in the waiting list control will be randomly allocated to either cbt or mct after 12 weeks of waiting period. the patients will be assessed with the primary measures at pre-treatment, at the end of treatment, and at follow-up after one and two years. in addition they will be assessed weekly on symptom measures and worry outcome diary. the therapist will be treating equally amount of patients in both conditions to control for any biased distribution connected to the therapist's characteristics. measures will be used on at least three main sources; self-report inventories (including symptom diaries), clinical assessments by independent raters and psycho-physiological assessments. we aim to (1) evaluate and compare the effectiveness of cbt and mct, (2) investigate the patterns of change and the mechanisms of action involved during treatment in each of the conditions and, (3) evaluate pre and post-treatment somatic change by psycho-physiological assessments as a response to cbt and mct.


Eligibility criteria:
inclusion criteria: 1. signed written informed consent obtained prior to entry in the study. 2. diagnosed with generalised anxiety disorder (dsm-iv, apa, 1994). 3. 18 years or older. exclusion criteria: 1. known somatic diseases 2. psychosis 3. past suicidal attempts and/or current intent 4. ptsd 5. cluster a or cluster b personality disorder 6. substance dependence 7. not willing to accept random allocation. 8. patients not willing to withdraw psychotropic medication for a period of 4 weeks prior to entry to the trial
evaluation of evodial hemodialyzer selectivity modifications (evodial +)

Conditions: End Stage Renal Disease (ESRD)

Summary: evodial +hemodialyzer consists of an evolution of the existing ce marked evodial device, with respect to the hemodialyzer membrane removal characteristics. different membrane prototypes configurations are proposed (3 versions in total), with the objective to modulate the hemodialyzer removal capacities (convective and adsorptive capacities). materials(including heparin grafted specifications) as well as the sterilization process are identical to the evodial hemodialyzer. based on available preclinical data , a clinical study is requested to document in vivo the different prototypes removal capacities with respect to middle molecular weight (mw) reference toxins such as b2 microglobulin and collect data with regards to protein loss.


Eligibility criteria:
inclusion criteria: 1. anuric patient (diuresis\<300ml) , 2. esrd patient treated for at least 3 months, 3. patient treated in hdf post-dilution, 4. vascular access functioning properly (qb \> 250 ml/min), 5. patient aged 18 years or more, 6. written consent to participate in the study (informed consent). exclusion criteria: 1. patient with pre-dialytic albuminemia \<3.3 g/dl(nephelometry assay) 2. patient with known allergy to heparin or type ii heparininduced thrombocytopenia (hit type ii); 3. patient under guardianship; 4. women pregnant or breast feeding; 5. patient included in other studies that could interfere with the goals of the current study. 6. patient that are not affiliated to the health system(beneficiary or dependent). 7. patient with positive serology (hiv, hepatitis).
multimodal investigation of intracranial clot environment

Conditions: Acute Ichemic Stroke; Brain Ischemia

Summary: analysis of peri clot blood collected at the acute phase of stroke in order to understand physiopathological mechanisms involved in the cerebrovascular damage

it has been shown that immune cells accumulate around the clot at the acute phase of stroke. leukocytes and their specific chemokines and cytokines regulation may impact cerebrovascular integrity.

Eligibility criteria:
inclusion criteria: 1. over 18 years of age, 2. non-dependent for activities of daily living prior to the onset of the mi (modified rankin score \>2) 3. having an occlusion of a large arterial trunk proven by imaging (angio-mri or angio-scanner). exclusion criteria: 1. patients initially admitted but for whom endovascular treatment will not finally be performed (re-infusion, catheterization failure...) will be excluded from the study. 2. major patients under guardianship or curatorship or patients deprived of liberty

Keywords: stroke blood brain barrier ischemia thrombus interventional neuroradiology
virtual reality on pulmonary function after upper abdominal surgeries

Conditions: Abdomen Hernia; Respiratory Complication

Summary: after upper abdomen surgery, respiratory muscle dysfunction is well recognised. after laparotomy and even laparoscopy, maximum static inspiratory and expiratory pressures are lowered, and recovery can take several days. a variety of reasons have been implicated in such respiratory muscle dysfunction, including irritation and inflammation, as well as injuries near the diaphragm, resulting in local mechanical failure, reflex inhibition, and pain.

virtual reality (vr) encourages an environment that attempts to create a moment of entertainment, motivation, and enjoyment with a variety of stimuli, with movements that stimulate physical and cognitive development, as well as the patient's active participation in the rehabilitation process. it is possible to assist in the alleviation of pain using the platform, at a low cost, through the playfulness given during rehabilitation, with an effective consumption of oxygen, range of motion, and use of the respiratory muscles more efficiently. participants with upper abdominal surgery will be randomly distributed into group a (vr group) which will receive vr for plus conventional physical therapy program and group b (control group) which will receive conventional physical therapy program.

Eligibility criteria:
inclusion criteria: 1. patients undergone open upper abdominal surgery (hernia repair, cholecystectomy, large bowel removal, conventional laparotomy) 2. no prior surgical intervention for esophageal, gastric, or biliary tract resection 3. age 18-60 years 4. acceptable physical condition (permitting pulmonary function and functional capacity test). exclusion criteria: 1. cerebrovascular disease 2. use of immunosuppressants within 30 days of surgery 3. cardiovascular instability 4. chest physical therapy within the 8 weeks preceding study enrollment 5. visual impairment or hearing impairment; 6. bed-ridden patients; 7. any lung disorders 8. insulin-dependent diabetes mellitus 9. less than 6-months post thoracic or cardiac surgery 10. musculoskeletal impairment 11. cognitive disorders 12. patients undergoing laparoscopic surgery as this induces smaller changes in the postoperative breathing mechanics than laparotomy does 13. heavy smokers or alcoholism

Keywords: virtual reality pulmonary function respiratory muscle strength functional capacity upper abdominal surgery
falls and cardiovascular events in pacemaker patients

Conditions: Bradycardia

Summary: the purpose of this study is to document the number of falls and fractures in sinus node disease (snd) patients.

the purpose of this study is to compare the number of falls and fractures in sinus node disease (snd) patients before versus after implantation of a mvp (trademark) pacemaker. further the effect of pacing in the mvp (trademark) mode in respect of cardiovascular events is going to be analyzed in the same population.

Eligibility criteria:
inclusion criteria: * sinus node disease (snd) treated with a pacemaker with mvp (tm) mode according to esc 2007 guidelines (snd as primary indication for pacemaker implant, implant within past two weeks) * geographic stability and availability for follow-up at the study center for the length of the study * willingness and ability to sign informed consent exclusion criteria: * age less than 50 years * impaired cognitive function (such as alzheimer's disease) * permanent av block ii and iii * persistent atrial fibrillation * life expectancy less than two years * enrollment or intended participation in another clinical trial during the course of this study * subject is pregnant or breastfeeding

Keywords: snd sinus node disease falls fractures
an open label trial of afatinib (giotrif) in treatment-naive (1st line) or chemotherapy pre-treated patients with locally advanced or metastatic non-small cell lung cancer (nsclc) harboring egfr mutation(s)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: to evaluate the safety and tolerability of afatinib (giotrif) in patients with locally advanced or metastatic non-small cell lung cancer (nsclc) harboring egfr mutation(s) and have never been treated with an egfr-tki


Eligibility criteria:
inclusion criteria: patients with: * locally advanced or metastatic non-small cell lung cancer (nsclc) * epidermal growth factor receptor (egfr) mutation-positive result per the institution's testing methodology. * adequate organ function, defined as all of the following: 1. absolute neutrophil count (anc) \> 1500/mm3. (anc \>1000/mm3 may be considered in special circumstances such as benign cyclical neutropenia as judged by the investigator and in discussion with the sponsor). 2. platelet count \>75,000/mm3 3. serum creatinine \< 1.5 times of the upper limit of normal 4. total bilirubin \< 1.5 times upper limit of (institutional) normal (patients with gilbert's syndrome total bilirubin must be \<4 times institutional upper limit of normal). 5. aspartate amino transferase (ast) or alanine amino transferase (alt) \< three times the upper limit of (institutional) normal (uln) (if related to liver metastases \< five times uln). * eastern cooperative oncology group (ecog) score between 0 - 2 * written informed consent by patient or guardian prior to admission into the trial that is consistent with international conference on harmonisation (ich)- good clinical practice (gcp) guidelines and local law. exclusion criteria: patients who or with: * prior treatment with an egfr tyrosine kinase inhibitor (tki) * anti-cancer treatment within 2 weeks prior to start of trial treatment (continued use of anti-androgens and/or gonadorelin analogues for treatment of prostate cancer permitted) * radiotherapy within 14 days prior to drug administration, except as follows: 1. palliative radiation to organs other than chest may be allowed up to 2 weeks prior to drug administration, and 2. single dose palliative treatment for symptomatic metastasis outside above allowance to be discussed with sponsor prior to enrolling. * previous or concomitant malignancies at other sites, except effectively treated non-melanoma skin cancers, carcinoma in situ of the cervix, ductal carcinoma in situ or effectively treated malignancy that has been in remission for more than 3 years and is considered to be cured. * known pre-existing interstitial lung disease * meningeal carcinomatosis and symptomatic brain metastases (patients with asymptomatic brain metastases, who were previously treated, are eligible provided they have had stable disease (sd) for at least 4 weeks on stable doses of medication)
tetracycline to limit the innate immune response in acute respiratory distress syndrome

Conditions: Adult Respiratory Distress Syndrome; Pneumonia; Sepsis

Summary: the acute respiratory distress syndrome (ards) is a severe form of respiratory failure with a mortality rate of approximately 40%. despite advances in its supportive treatment such as lung protective ventilation or restrictive fluid management, no effective pharmacotherapy exists to treat ards. emerging preclinical data indicates that excessive activation of the inflammasome-caspase 1 pathway plays a key role in the development of ards. tetracycline has anti-inflammatory properties via inhibiting inflammasome-caspase-1 activation. since not much is known about the activation of the inflammasome in clinical ards, the purpose of this study is i) to investigate the the inflammasome-caspase-1 activation in clinical ards and ii) inhibit the innate immune response of alveolar leucocytes obtained by tetracycline from patients with ards


Eligibility criteria:
inclusion criteria: * age \> 18 years * informed consent of the patient * diagnosis of ards for \< 48 h exclusion criteria: * age \< 18 years * missing informed consent * immune therapy * autoimmune disease

Keywords: inflammasome caspase nlrp3 antibiotics tetracycline
usefulness of probe-based confocal laser endo-microscopy in delineation of margin of early gastric cancer for endoscopic submucosal dissection

Conditions: Early Gastric Cancer

Summary: the aim of this study is to evaluate the usefulness of pcle (probe-based confocal laser endomicroscopy) compared with conventional chromoendoscopy (ce) for delineating the margin of early gastric cancer (egc) with endoscopic submucosal dissection (esd).


Eligibility criteria:
inclusion criteria: * consecutive patients diagnosed as egc and treated by esd with following criteria:1) differentiated mucosal cancer without ulcer 2) differentiated mucosal cancer with ulcer, ≤ 3 cm 3) differentiated minute (\<500 μm) submucosal invasive cancer, ≤ 3 cm 4) undifferentiated mucosal cancer without ulcer, ≤ 2 cm * consecutive patients diagnosed as low- and high-grade dysplasia with suspicion of egc and treated by esd exclusion criteria: * coagulopathy : international normalized ratio \[inr\] \> 1.5 or platelet count \<50,000 cell/cubic millimeter) * impaired renal function : cr \> 1.2 mg/dl * pregnancy or breast-feeding * age \< 20 years * allergy to fluorescein dye * inability to provide informed consent

Keywords: probe-based confocal laser endomicroscopy (pcle), early gastric cancer (egc), endoscopic submucosal dissection (esd), margin
clinical outcome of female non-gastric gastrointestinal stromal tumor

Conditions: Gastrointestinal Stromal Tumor

Summary: to elucidate the prognosis of women with non-gastric primary gastrointestinal stromal tumors.

gastrointestinal stromal tumor (gist) are mesenchymal tumors arising from gastrointestinal tract, mesentery, or omentum. they took up about 3% of gastrointestinal malignancies. although rarely, the clinical presentation of non-gastric gist might mimick ovarian cancer, and would be managed by gynecologists. therefore, retrospective review of female non-gastric gist cases will be performed to investigate the clinical outcome of non-gastric gist. the result of this study might be used as an important reference for gynecologists.

Eligibility criteria:
inclusion criteria: * \> 20 years of women. * non-gastric gastrointestinal stromal tumor exclusion criteria: * those without pathological report or surgical record.
tacrolimus ointment long term safety in young children with atopic dermatitis

Conditions: Dermatitis, Atopic

Summary: the objective of this study is to assess the safety and efficacy of 0.03% tacrolimus ointment as long-term treatment in paediatric patients with atopic dermatitis.

this is a long-term, multi-centre, non-comparative phase ii study. all centres participating in the fg-506-06-32 pharmacokinetics study will be offered the protocol as a follow-up. only patients enrolled by those centres for the above mentioned study, who applied at least one dose of study medication and benefited from treatment with 0.03% tacrolimus ointment, can be enrolled. during episodes of active disease, a thin coat of ointment is applied on each lesion. in the first three weeks, frequency of application is twice a day; after three weeks treatment is continued once a day. all atopic dermatitis lesions are treated until clearance (i.e. itch has gone). in case of a flare-up or worsening treatment twice daily treatment is re-started for three weeks and thereafter reduced to once daily. safety is assessed from adverse events reported by the patient and/or his parents or observed by the investigator at the site of application and elsewhere. the safety evaluation includes monitoring of routine haematology and serum chemistry parameters. blood samples are analysed by local laboratories. blood samples are taken to determine concentrations of tacrolimus. height, weight and pulse of the patient are recorded at each visit. efficacy is assessed by physician's global evaluation of clinical response, patient's parent/guardian's assessment of global response, physician's assessment of individual signs and the affected area assessment.

Eligibility criteria:
inclusion criteria: * patient has participated in the study fg-506-06-32, has applied at least one dose of study medication and has benefited from treatment in the opinion of the investigator. * patient is likely to benefit from further treatment with tacrolimus ointment in the opinion of the investigator. exclusion criteria: * patient has a skin disorder on the affected (and to be treated) area, other than atopic dermatitis, requiring treatment. * patient has clinically infected atopic dermatitis.

Keywords: paediatric patients tacrolimus dermatitis, atopic
predicting pain exacerbations in children with complex regional pain syndrome (crps)

Conditions: Complex Regional Pain Syndromes

Summary: objectives: identify physiologic, dietary, and environment triggers of severe pain exacerbations in children with crps.

hypothesis(es) and aims: investigators hypothesize that spontaneous exacerbations ("flares") of limb pain caused by crps have identifiable and predictable precipitants and timing. the aim of this trial is (1) to aggregate large databases of real-time physiological, psychological, subjective pain, environmental and dietary data and analyze these data with artificial intelligence (ai) to identify temporal precipitants to pain exacerbations, and (2) to identify potential strategies to interrupt the progression of acute pain flares based upon what is learned. early treatment and strategies to interrupt acute pain flares would have a significant effect on quality of life in this patient population while undergoing treatment and resolution of the ongoing condition. design: design of the study: prospective observational study. subjects: will be recruited from stanford's pediatric pain clinic and other like centers nation-wide. subjects will be issued an apple watch and the medeloop app for data collection. data collection: medeloop will collect subjects' electronic medical records (existing and prospective) if subjects sign into the hospital's patient portal through medeloop. the apple watch will transmit physiologic data to medeloop in real time for a period of 6 months to derive physiologic parameters from apple watch measured pulse rate, oxygen saturation, time in daylight, ecg measurement, and movement/activity. derived variables include heart rate variability, sleep hours, daily distance walked, right/left weight bearing and gait and others. using a paired smartphone, subjects will photograph all meals for analysis of the dietary content by ai, which will be transmitted to medeloop after capture for ai analysis. medeloop software will use location data and cross-reference corresponding environmental and weather data (e.g., atmospheric conditions, air and water quality) on a daily basis. all pain flares will be recorded in real time via the medeloop app.

Eligibility criteria:
inclusion criteria: * clinical diagnosis of... exclusion criteria: -

Keywords: child pediatrics pain neuropathic crps
the impact of preoperative urostomy education on patients and families

Conditions: Bladder Cancer; Urostomy

Summary: this is an observational study utilizing a qualitative descriptive methodology with a thematic analysis approach to explore the impact of a preoperative educational intervention ("stoma bootcamp") on patients and their family/informal caregivers

this study will utilize a qualitative descriptive methodology with a thematic analysis approach. individual interviews will be held with bladder cancer and caregiver dyads who participated in the stoma bootcamp study. interviews will explore the patient's and caregiver's experiences and perceptions of ostomy surgery prior to the bootcamp and after the bootcamp from a physical, psychological, social, and spiritual perspective. semi-structured interview guides will be developed using engel biopsychosocial model (bps),5 one guide geared towards patients and the second toward caregivers.

Eligibility criteria:
inclusion criteria: * adult (age ≥ 18 years) patients who underwent radical cystectomy for bladder cancer at the university of kansas medical center since 2016, and * participated in the stoma bootcamp preoperative educational intervention, and * identified an informal/family caregiver who participated in stoma bootcamp with them. * patient-caregiver dyads must both consent to participation exclusion criteria: -