Kornimate/medical-research-clean huggingface dataset:
effects of different oxygen devices in hypoxemic copd patients

Conditions: Chronic Obstructive Pulmonary Disease Severe

Summary: taken recent literature together, there is a sufficient number of trials investigating the effect of different oxygen devices. however, studies comparing oxygen delivery via portable oxygen concentrator (poc) and liquid oxygen device (lod) with appropriate exercise testing and sufficient power are missing. given that walking is the most important activity of daily life to preserve the maintenance and to participate in social life, we aim to investigate the effects of two different oxygen delivery systems during walking in hypoxemic copd patients (poc vs. lod). the endurance shuttle walk test (eswt) is well validated for measuring endurance walking capacity in copd patients with good repeatability. the advantage of this test over the 6mwt is that the eswt is performed at 85% of the individual maximum which is close to the intensity of typical daily activities. due to the fact that the eswt enables us to determine the maximum duration of exercise and to compare values at isotime (at the point of time when the shortest of the 3 eswts ends), we use the eswt as exercise test in our trial.


Eligibility criteria:
inclusion criteria: * copd patients (gold stage iii to iv) with hypoxemia at rest or during exercise (pao2\<60mmhg) * participation in an inpatient pulmonary rehabilitation program (schön klinik bgl) * written informed consent exclusion criteria: * general exclusion criteria for exercise tests, e.g. acute coronary syndrome, acute myo- or pericarditis, acute lung embolism, pulmonary infarction, acute uncontrolled heart insufficiency * signs of acute exacerbation * any orthopedic or neurological disabilities that prevent patient from walking

Keywords: supplemental oxygen concentrator endurance shuttle walk test
m7824 in combination with chemotherapy in stage iv non-small cell lung cancer (nsclc)

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: the main purpose of the study was to evaluate the safety and tolerability of m7824 in combination with chemotherapy.


Eligibility criteria:
inclusion criteria: * participants greater than or equals to (\>=) 18 years of age inclusive at the time of signing the informed consent * participants who have histologically confirmed diagnosis of stage iv nsclc: 1. participants in cohort a, b, and c must not have received prior systemic therapy treatment for their stage iv nsclc 2. participants who had disease progression on previous treatment with programmed death-ligand 1 (pd- l1) inhibitors in combination with platinum-based chemotherapy are enrolled in cohort d, as long as therapy was completed at least 28 days of the first study intervention. * have measurable disease based on response evaluation criteria in solid tumors (recist) 1.1 * have a life expectancy of at least 3 months * availability of archived tumor material (less than \[\<\] 6 months old) adequate for biomarker analysis is mandatory at screening, central laboratory confirmation is required. fresh biopsies should be collected if archived tumor material is not available * eastern cooperative oncology group performance status (ecog ps) of 0 to 1 at study entry and date of first dose exclusion criteria: * the participant's tumor harbors an epidermal growth factor receptor (egfr) sensitizing (activating) mutation,ros1 rearrangement, or braf v600e mutation or anaplastic lymphoma kinase (alk) positive, if targeted therapy is locally approved * mixed small cell with nsclc cancer histology * has received major surgery within 4 weeks prior to the first dose of study intervention; received thoracic radiation therapy (rt) of \> 30 gray (gy) within 6 months prior to the first dose of study intervention * previous malignant disease (other than the target malignancy to be investigated in this study) within the last 3 years * has known active central nervous system (cns) metastases and/or carcinomatous meningitis. participants with previously treated brain metastases may participate provided they are clinically stable for at least 2 weeks after the end of the rt and, have no evidence of new or enlarging brain metastases evaluated by imaging, preferably brain magnetic resonance imaging (mri) * known severe hypersensitivity to study intervention or any components in their formulations * for participants in cohort a, b and c: has received prior systemic therapy for stage iv nsclc, including anti-pd-1, anti-pd-l1, anti-pd-l2, anti-cd137, or anti-cytotoxic t-lymphocyte-associated antigen-4 (ctla-4) antibody (including ipilimumab or any other antibody or drug specifically targeting t-cell co-stimulation or checkpoint pathways) * unable to tolerate computed tomography (ct) or mri in the opinion of the investigator and/or allergy to contrast material.

Keywords: non-small cell lung cancer bintrafusp alfa (proposed inn) m7824 stage iv intr@pid lung 024
reproducibility and reliability of epstein-barr virus (ebv) dna/rna measures in nasopharyngeal swabs

Conditions: Suspect NPC Patients; NPC Multiplex Families

Summary: nasopharyngeal carcinoma (npc) is a virus-associated cancer that is rare among caucasians but occurs at an elevated rate among southern asians. rates of npc are particularly high among individuals with a family history of this disease, but no specific genetic factors have been identified that can serve to guide clinical management of this high-risk population to ensure early detection and treatment of this life-threatening condition.


Eligibility criteria:
inclusion criteria: * suspect npc patients exclusion criteria: -
evaluation of silverlon dressing for autogenous skin donor sites

Conditions: Burns

Summary: the purpose of this study is to compare one type of dressing against the current standard dressing that is used to cover an unburned area of the skin where a piece of skin is removed to cover another part of the body that was burned. hypothesis: the mean healing time for wounds treated with the silverlon dressing will be less than the mean healing time for wounds treated with xeroform dressing.

at the time of the procedure, donor sites that are symmetrical in size and shape will be selected. once the grafts have been harvested, the wounds will be randomized for treatment using either the silverlon dressing or xeroform. the wound dressings will then be observed at least once a day beginning 72 hours after surgery until healed, defined as 90% or more of the wound surface being confluently re-epithelized.

Eligibility criteria:
inclusion criteria: * 18 years or older; male or female. * burn wounds of less than 30% total body surface area (tbsa) with no systemic abnormalities * burns do not involve the harvesting area * burn wounds require excision and grating of sufficient extent to justify two donor sites of equal and symmetrical size on non-dependent body surface areas * scheduled excision and grafting procedures is the first such operation for subject during this hospitalization * subject agrees to participate in follow-up evaluations exclusion criteria: * critical illnesses requiring ventilator support, systemic infection or hemodynamic instability * major acute or chronic illnesses affecting wound healing (e.g. peripheral vascular disease, insulin dependent diabetes, blood clotting disorder) * subject receiving medications that inhibit/compromise wound healing (e.g. anticoagulants, antiplatelet drugs, oral steroids). the use of anticoagulants does not include deep vein thrombosis (dvt) prophylaxis. * cellulitis or other infection of potential donor site * previously harvested donor site * subject with greater than 30% tbsa burns * subjects with sensitivity to silver or nylon * pregnancy

Keywords: burns donor site care silverlon dressing
the association of microrna21-155 levels with acute side effects in patients with stage iii nsclc with definitive crt

Conditions: Non-small Cell Lung Cancer Stage III

Summary: the present investigation constitutes a prospective cohort study. the objectives encompass the assessment of mirna expression levels in total exosomes derived from peripheral circulation tissues of stage iii definite krt nsclc patients both at the beginning and conclusion of their treatment. furthermore, an exploration is conducted into the potential correlation existing between alterations in mirna levels and the incidence of acute treatment-related side effects.

categorical variables were illustrated using both percentage distributions and numerical counts, while continuous variables were characterized using the mean accompanied by the standard deviation, and the median accompanied by the minimum and maximum values. the assessment of the normality of continuous variables encompassed a combination of visual methods such as histograms and probability plots, along with analytical tests like the kolmogorov-smirnov and shapiro-wilk tests. in instances where data exhibited a normal distribution, student's t-test was utilized for comparing two groups. for non-normally distributed data, the mann-whitney u test was applied. the comparison of categorical variables between independent groups involved chi-square and fisher's exact tests. changes within dependent groups were evaluated using the wilcoxon test. when performing pairwise comparisons among three or more groups, p-values were calculated while employing bonferroni correction. for the statistical analysis of the research data, the statistical package for social sciences (spss) version 25.0 for windows (spss inc. chicago, usa) was utilized. the significance level was set at p\<0.05. additionally, it is important to note that p-values falling within the range of 0.1 to 0.05 were considered indicative of a statistical trend in this study.

Eligibility criteria:
inclusion criteria: * patient over 18 years old. * to be between 0-2 according to eastern cooperative oncology group (ecog) performance status (ps). * patient with pathological diagnosis of nsclc. * stage 3 patient * patient with a definitive chemoradiotherapy (crt) treatment plan. exclusion criteria: * patient with second primary malignancy. * history of previous radiotherapy to the thoracic region * patient with advanced cardiovascular disease. * patient with neurological or physical deficit. * patient with autoimmune disease

Keywords: non-small cell lung cancer radiotherapy microrna-21 microrna-155 acute side effect
a placebo-controlled single-dose trial of sildenafil in schizophrenia

Conditions: Schizophrenia

Summary: the study is a double-blind, placebo-controlled, random-order, single-dose crossover trial of sildenafil 50 \& 100 mg added to stable antipsychotic treatment in schizophrenia patients to assess whether this pde5 inhibitor improves cognitive functioning (including verbal memory, fluency, attention, spatial memory, motor speed, and executive function) and clinical symptoms (psychotic, negative, mood symptoms, and self-reports of side-effects).

specific aims: 1. evaluate the effects of single doses of sildenafil 50 \& 100 mg compared to placebo on cognitive functioning, including verbal memory, fluency, attention, spatial memory, motor speed, and executive function. 2. evaluate the effects of single doses of sildenafil 50 \& 100 mg compared to placebo on psychotic, negative, and mood symptoms. 3. assess self-reports of side effects of sildenafil 50 \& 100 mg. location and subjects: 25 adult outpatients with schizophrenia will be recruited from the massachusetts general hospital outpatient clinic or the freedom trail clinic of the lindemann center. all research procedures will be performed at the psychopharmacology clinic of the massachusetts general hospital. subjects must be english speaking because the cognitive battery has only been validated in english.

Eligibility criteria:
inclusion criteria: 1. diagnosis of schizophrenia, any subtype. 2. age 18-65 years 3. male or female 4. clinically stable without a medication change within 4 weeks 5. able to complete cognitive testing (must be english-speaking) 6. willing to use appropriate birth control during study participation (if female) exclusion criteria: 1. active substance abuse or dependence 2. pde 5 inhibitor taken within 24 hours of study drug 3. currently taking a drug that inhibits hepatic cytochrome p450 3a4 (eg. nefazadone, fluvoxamine, erythromycin, ketoconazole, itraconazole, cimetidine, saquinavir, ritonavir, st. john's wort, or grapefruit juice). 4. currently taking drugs that induce p45 3a4 (eg. phenytoin, carbamezapine, phenobarbital, rifampin) 5. unstable medical disease 6. significant cardiac disease 7. bleeding disorder 8. peptic ulcer disease 9. hepatic impairment 10. moderate or greater renal impairment 11. history of migraines 12. currently taking nitrates or alpha blockers 13. resting blood pressure \ 140/90 mm. 14. history of intolerance to pde5 inhibitors 15. history of inappropriate sexual behavior (eg, masturbation in public, stalking, assault) 16. history of priapism 17. pregnant or lactating

Keywords: schizophrenia cognition sildenafil pde5 inhibitor
study of magnetic brain stimulation in treatment of obsessive compulsive disorder

Conditions: Obsessive Compulsive Disorder

Summary: in a preliminary pilot study, the investigators tested the efficacy of rtms over the medial prefrontal cortex in symptom profiles of obsessive compulsive disorder (ocd) patients. this study revealed considerable benefit in using rtms for the treatment of ocd. in the current proposal, in a randomized clinical trial, the investigators aim to further evaluate the efficacy of rtms in ocd in a larger sample size and for a longer period. studies into the efficacy of rtms in other psychiatric disorders such as depression have consistently shown that extension of the treatment to four weeks significantly increased the effect size. in the pilot study, the investigators applied rtms for only two weeks. although all patients consistently showed improvement in their symptoms, none of them showed complete remission of their ocd. here, the investigators hypothesize that longer duration of rtms treatment will have greater benefit in ocd symptom reduction.

the purpose of study is to examine the efficacy of rtms over the medial prefrontal cortex in the treatment of ocd. rtms will be provided to ocd patients in a randomized double blind controlled setting, and the investigators hypothesize that in this setting the treatment group would still show significant improvement in ocd symptoms as compared to the sham group. rtms will be applied for four weeks on ocd patients and the investigators will assess improvement after four weeks of rtms. the investigators hypothesize that patients will show significantly greater improvement after four weeks of rtms vs. two weeks of rtms.

Eligibility criteria:
inclusion criteria: * diagnosed obsessive compulsive disorder * not currently receiving cognitive behavioural therapy * not currently on any medication or only taking one selective serotonin reuptake inhibitor (ssri) exclusion criteria: * history of psychotic episodes * history of neurological illness * previous head injury * active alcohol or substance abuse * history of seizure disorders * currently pregnant
the effect of loss of offset after pertrochanteric fracture treated with a intramedullary nail

Conditions: Intertrochanteric Fractures

Summary: the purpose of this study is determine the relationship between pain and protrusion of the implant after surgery for a intertrochanteric fracture.

intertrochanteric fractures are common fractures in which severe complications such as non-union, implant cut-out and postoperative wound-infections occur at very low rates with modern surgical techniques. while severe complications are rare, the patient reported outcome is less satisfactory with roughly half of the patients complain of thigh pain and others failing to regain their walking ability. the current leading methods for osteosynthesis of intertrochanteric fractures are intramedullary (im) nails and sliding hip screws (shs). over the period 1998 to 2007 the use of im nails for pertrochanteric fractures increased from 5% to 20% in sweden, at the expense of the use of shs (5). im nailing has also become more common at our clinic where we since february 2008 use the 3rd generation of the gamma nail. in this study we investigate if the increased pain after im nailing, reduced hip function and life quality may correlate to the compression over the fracture and the lateral protrusion of the intramedullary nail.

Eligibility criteria:
inclusion criteria: * intertrochanteric fracture * age over 55 * intramedullary nailing exclusion criteria: * severe cognitive impairment * substance abuse

Keywords: intertrochanteric fractures intramedullary nailing hip function pain
swiss study for the treatment of copd patients with the free combination of indacaterol and glycopyrroniumbromide.

Conditions: Chronic Obstructive Pulmonary Disease: COPD

Summary: the study purpose is to evaluate the effect of qab149 * nva237 vs. qab149 on static lung hyperinflation.

this is a multicenter, randomized, double-blinded, single-dose, cross-over, placebo-controlled study. the primary endpoint was chosen to demonstrate the superiority of a single-dose of the combined inhalation vs. the mono inhalation regarding the inspiratory capacity (ic) peak value. a total of 78 patients will be randomized to complete two visits with two single doses of treatment. patients will be randomized in a cross-over manner. treatment visits will be separated by a study medication wash-out period.treatments will be administered in a blinded fashion. the patients will be male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe copd according to global initiative for chronic obstructive lung disease (gold) criteria and \>10-pack years history of smoking, fev1 \<80% and ≥30% of the predicted normal value.

Eligibility criteria:
inclusion criteria: * male and female patients, ≥40 years of age, with a documented diagnosis of moderate or severe copd according to global initiative for chronic obstructive lung disease (gold) criteria and \>10-pack year history of smoking * fev1 \<80% and ≥30% of the predicted normal value who have signed an informed consent form prior to the initiation of any study-related procedure exclusion criteria: * no copd exacerbations within 6 weeks prior to dosing * no concomitant lung disease such as asthma * nno requirement for long term oxygen treatment or history of lung reduction surgery * no medical conditions that would interfere with the performance of spirometry * no other medical condition that in the opinion of the investigator may cause the patient to be unsuitable for completion of the study or place the patient at potential risk form being in the study e.g. uncontrolled hypertension or unstable ischemic heart disease.

Keywords: moderate to severe copd patients are included nva qab
transcranial pulse stimulation for depression

Conditions: Major Depression

Summary: transcranial pulse stimulation (tps) is a newly developed brain stimulation therapy from austria \& germany with highly promising applicability in neuropsychiatric disorders. major depressive disorder (mdd) is the world's leading cause of disability. novel treatment approaches are urgently needed given that a significant fraction of patients does not sufficiently respond to standard antidepressant treatments. our open-label pilot study using tps in mdd indicates preliminary efficacy. however, experimental control is necessary to infer reliable scientific evidence for the efficacy of tps. here, we propose a randomized, double-blind, sham-controlled clinical trial to probe the utility of tps as a modern antidepressant treatment.


Eligibility criteria:
mdd group inclusion criteria: * age 18 to 60; * a clinical diagnosis of a mdd and a hamd17 score ≥14; * treatment naivety or stable (≥4 weeks) psychopharmacological medication. exclusion criteria: * severe internal diseases including blood clotting disorders; * neurological disorders including bleeding prone micro-pathologies or a history of severe head injuries; * current psychiatric comorbidities, including addiction; * pregnancy; * common nibs exclusion criteria, such as a history of brain surgery, cardiac pacemaker, deep brain stimulation and intracranial metallic particles.

Keywords: transcranial pulse stimulation brain stimulation major depression
to evaluate the delivery timing safety and efficacy of antitachycardia pacing (bio|atp)

Conditions: Implantable Cardioverter Defibrillator(ICD)

Summary: to compare treatment group (settings of early multiple atp) and control group (settings of extended detection time for the conventional atp) in japanese patients, and confirm their safety and efficacy

the enrolled patients are randomized to treatment group with setting to provide antitachycardiac pacing (atp) multiple times at an early timing or control group with long detection setting for the conventional atp, at latest 10 days after the implantation of the implantable cardioverter defibrillator(icd) system in the domestic centers to confirm the safety and efficacy of the setting for the early timing multiple atp treatment in japanese patients. the follow-up is not pre-defined and the data (including the home monitoring data) is collected according to the site's standard outpatient schedule, but the data will be collected at the hospital visit for the initial appropriate or inappropriate shock therapy.

Eligibility criteria:
inclusion criteria: * patient has an indication for icd according to the the japanese circulation society (jcs )/ japanese heart rhythm society (jhrs) 2021 guideline focused update on non-pharmacotherapy of cardiac arrhythmias * patient is either planned for de novo icd implantation or is already implanted with an investigational icd for 10 days or less. * patient can be treated with atp therapy for both vt and vf zone * patient is willing and able to use the cardiomessenger and accepts the home monitoring concept * patient is willing to visit the hospital in accordance with physician's instruction * patient is able to understand the nature of the study and to provide written informed consent exclusion criteria: * patient planned for implantation with or already implanted with cardiac resynchronization therapy defibrillator (crt-d) device * a patient who is confirmed to have received icd therapy * a patient who is diagnosed as idiopathic vf (e.g. brugada syndrome, long qt syndrome, other ivf) * age \< 18 years * a patient who has impaired mental status * life expectancy less than 18 months * participation in another interventional clinical investigation * pregnant or breastfeeding

Keywords: icd shock antitachycardiac pacing(atp) ventricular tachycardia(vt) ventricular fibrillation(vf) ventricular arrhythmias(va)
bevacizumab for central retinal vein occlusion study

Conditions: Central Retinal Vein Occlusion

Summary: central retinal vein occlusion is a leading cause of severe visual impairment. until now, no treatment has been available to improve visual acuity. the present study intends to investigate if intravitreal bevacizumab can improve visual acuity as compared to sham-treated control patients.


Eligibility criteria:
inclusion criteria: * crvo with duration \< 6 months * visual acuity of 20/800 to 20/50 exclusion criteria: * crvo with duration of \> 6 months * previous treatment with anti-angiogenic drugs

Keywords: crvo anti-vegf macular edema