Kornimate/medical-research-clean huggingface dataset:
effects of body position on diaphragmatic activity in patients requiring noninvasive ventilation for acute respiratory failure covid-19 related

Conditions: Noninvasive Ventlation; COVID-19 Respiratory Infection; Diaphragm Injury

Summary: the present investigation aims to assess the diaphragmatic thickening fraction, reflecting the diaphragmatic activity, during supine (baseline) and at 1 hour following prone position in patients assisted through non invasive ventilation due to hypoxemic acute respiratory failure related to covid-19. also, the impact of lung aeration and comfort were ascertained in the same setting

primary aim is to asses the effects of body position on diaphragmatic thickening fraction (primary aim) and lung aeration and vital sign (secondary aims) in patents assisted via noninvasive ventilation (niv) for hypoxemic acute respiratory failure (harf) associated to covid-19. all adult patients, admitted for harf due to covid-19 and requiring niv were enrolled. diaphragmatic thickening fraction, lung aeration assessed through ultrasound, comfort, and grade of sedation-agitation as well as vital signs, i.e., peripheral oxygen saturation, blood pressure, and breathing pattern were monitored during noninvasive ventilation in supine and after 1 hour following the switch to prone position.

Eligibility criteria:
inclusion criteria: * covid-19 infection, * age \> 18 years, * niv application, * icu admission exclusion criteria: * pregnancy, * all the conditions contraindicating prone position and niv
trial of colistin versus meropenem in ventilator-associated pneumonia (vap) (cr-gnb)

Conditions: Ventilator-associated Bacterial Pneumonia

Summary: 1. to demonstrate that colistin iv. is not inferior to meropenem in empiric treatment of vap regarding the final point of primary efficacy: mortality in the 28 subsequent days and clinical healing in patients clinically evaluated. 2. to compare the safety of treatment with colistin vs meropenem in vap. 3. to compare microbiological efficacy of treatment with colistin vs meropenem in vap

study drugs: patients will be randomized a 1:1 rate and open label fashion to two interventions: group 1: colistin loading dose followed by colistin infusion iv/8h or group 2: meropenem 2 g/iv/ 8 h. the overall treatment time will be a minimum of 8 days. follow-up visits will be performed at baseline, 72 h, 8 days, the end of treatment, and 28 days from recruitment icu discharge, hospital discharge or death.

Eligibility criteria:
inclusion criteria: age ≥ 18 years with clinical and radiological criteria of vap. the women of childbearing age (not surgically sterilized and in the period between menarche and 1 year after the menopause) must have a negative test of pregnancy in urine at the time of recruitment. the patient or his/her legal representative must sign a document of informed consent approved by the ethics review committee. exclusion criteria: hypersensitivity to the two antimicrobials of the study (colistin/meropenem). renal insufficiency in substitute treatment. corporal weight \ 150 kg. patients previously included in another clinical trial.

Keywords: vap mdr-gnb colistin meropenem
a double-masked, randomized, placebo-controlled,pilot study of diquafosol tetrasodium in subjects following photorefractive keratectomy (prk)

Conditions: Photorefractive Keratectomy

Summary: the objectives of this trial are to: * assess the safety and tolerability of diquafosol tetrasodium ophthalmic solution versus placebo following one week of treatment in subjects undergoing photorefractive keratectomy (prk). * evaluate the potential of diquafosol to accelerate corneal wound healing/re-epithelialization following prk.


Eligibility criteria:
inclusion criteria: * between age 18 - 45 years old * candidate for bilateral prk exclusion criteria: * dry eye disease * any corneal pathologies * previous corneal or intraocular surgeries

Keywords: post prk wound healing
a study of bms-986449 with and without nivolumab in participants with advanced solid tumors

Conditions: Advanced Solid Tumors

Summary: the purpose of this study is to evaluate the safety and efficacy of bms-986449 alone and in combination with nivolumab in participants with advanced solid tumors.


Eligibility criteria:
inclusion criteria: * all participants must have a histologically or cytologically confirmed, advanced, unresectable/metastatic, solid malignancy (measurable by response evaluation criteria in solid tumors \[recist\] v1.1), and have received, be refractory to, ineligible for, or intolerant of existing therapy(ies) known to provide clinical benefit for the condition of the participant. * part 1a may have a solid malignancy of any histology. * part 1b is restricted to participants with non-small cell lung cancer (nsclc). * part 1c is restricted to participants with triple-negative breast cancer (tnbc). * tumor biopsy must be obtained for all participants (unless medically precluded). exclusion criteria: * history of grade ≥ 3 toxicity related to prior t-cell agonist or checkpoint inhibitor therapy (eg, anti-cytotoxic t-lymphocyte-associated antigen 4 \[ctla-4\], or anti-pd- 1/programmed death-ligand 1 \[pd-l1\] treatment, or any other antibody or drug specifically targeting t-cell co-stimulation or other immune checkpoint pathways) except those that are unlikely to re-occur with standard countermeasures. * current or recent (within 3 months of study intervention administration) gastrointestinal disease or gastrointestinal surgery (eg, intestinal/gastric/colon resection) that could impact the absorption of study intervention. * any significant acute or chronic medical illness which would interfere with study intervention or follow-up in the opinion of the investigator. other protocol-defined criteria may apply.

Keywords: bms-986449 nivolumab cancer solid tumors non-small cell lung cancer (nsclc) triple negative breast cancer (tnbc)
autologous stem cell treatment for chronic lung disease study

Conditions: COPD; Interstitial Lung Disease

Summary: the purpose of the lung institute is to collect and isolate a patient's own cells and platelet rich plasma (prp) and deliver the product back to the patient the same day. lung institute's treatment is limited to self-funded patients with chronic lung disease- chronic obstructive pulmonary disease (copd) and restrictive lung diseases such as pulmonary fibrosis (pf) and interstitial lung disease (ild). the patient's cells and platelet rich plasma are harvested through venous or bone marrow collection techniques. the hypothesized outcomes of therapy are safety and minimization of adverse events, a perceived improvement in the patient's lung condition (to be determined by their perceived quality of life), an improvement in the fev1 among copd patients, the ability to reduce supplemental oxygen use, the ability to function well without the use of rescue inhalers, reduction of secondary pulmonary infections, reduction in emergency room visits and exacerbations related to their disease.

through the collection of outcomes data, lung institute aims to explore and describe the safety and efficacy of autologous stem cell treatment for chronic lung disease with dissemination to the public and to the medical community for the advancement of regenerative medicine. the study aims to confirm the safety of autologous cell therapy, explore the effect of autologous cell therapy treatment on pulmonary function over time, and to describe the anecdotal quality of life changes of patients following treatment using quantitative and qualitative measures.

Eligibility criteria:
inclusion criteria: * patients are included in treatment by self-referral and after consultation with a designated patient coordinator who determines initial eligibility, and then by the clinic nurse practitioner or physician of lung institute who determines final eligibility for inclusion. all eligible treated patients are eligible for the study. exclusion criteria: * patients who are unable to provide informed consent, pregnant patients, prisoners, non-english speakers, patients with a history of cancer within the past 5 years, patients with active tuberculosis or pneumonia. in addition, patients on prescribed blood thinners, with a history of breast or prostate cancer of any time frame or with a history of osteoporosis are excluded from the bone marrow harvest option.

Keywords: shortness of breath breathlessness stem cells platelet rich plasma quality of life pulmonary function
hormonal sensitivity in patients with noonan and leopard syndromes

Conditions: Noonan Syndrome; LEOPARD Syndrome

Summary: noonan and leopard syndromes share, with variable severity, different clinical traits, notably craniofacial manifestations, cardiopathies, short stature, and juvenile cancers. the main genetic cause of these syndromes is missense mutation of the gene encoding the ubiquitous tyrosine phosphatase shp2, found in more than half the patients with ns and in 80% of ls cases. shp2 plays pivotal roles in development, growth, and metabolism by regulating key signalling pathways (ras/mitogen activated protein kinase (mapk), phosphoinositide-3 kinases (pi3k)/akt) in response to growth factors/hormones. deregulation of these signalling pathways has been causally linked to ns and ls pathophysiology. this project aims at better understanding hormonal sensitivity abnormalities in patients with noonan syndrome (ns) or leopard syndrome (ls) caused by mutations of the tyrosine phosphatase shp2. to reach this goal, the investigators will take advantage of different tissues (fibroblasts ± adipocytes) from patients with ns / ls compared to healthy controls. all patients will have a skin biopsy and only patients about to undergo surgery will have a adipose tissue biopsy.

the activation of different signaling pathways (ras/mapk, pi3k/akt) in response to growth factors/hormones (growth hormone, insulin) in fibroblasts and/or in adipocytes from patients with ns or ls will be compared to those of healthy subjects. these data will be correlated to clinical, hormonal, and biochemical characteristics of patients

Eligibility criteria:
inclusion criteria: patients with noonan syndrome (ns) or leopard syndrome (ls): * female or male * age between 5 to 15 years * clinical diagnosis of ns or ls according to published criteria * signed informed consent of parents healthy controls: * female or male * age between 5 to 15 years * no personal history of syndrome or chronic disease * planned surgical procedure * signed informed consent of parents exclusion criteria: * age below 5 or above 15 years * pregnancy in healthy controls: syndromic or chronic disease

Keywords: hormonal sensitivity bone growth
comparison of antimicrobial action of sodium hypochlorite and polyhexamethylene biguanide as root canal irrigants

Conditions: Irreversible Pulpitis

Summary: the aim of this randomized clinical trial is to compare the antibacterial effects of sodium hypochlorite (naocl) and polyhexamethylene biguanide during root canal treatment .

this study will compare the antibacterial effectiveness of sodium hypochlorite and phmb, to find out whether phmb can be used as a substitute to naocl. polyhexamethylene biguanide (phmb), is a disinfectant solution having a broad spectrum of antimicrobial activity and is investigated as an endodontic irrigant. it is non-corrosive, non-toxic and acts by disrupting cell membrane integrity.

Eligibility criteria:
inclusion criteria: * • patients aged 18 to 50 years * both male and female patients * periodontally healthy teeth as determined by periodontal probing * patients with non-vital necrotic pulps as determined by cold test * patients with acute apical periodontitis determined by history and clinical examination * clinical findings: visual: carious tooth decay occlusion: hyperocclusion pulp vitality test: negative periapical radiograph: caries involving pulp space and pdl widening percussion test: positive palpation test: negative • single rooted teeth as determined radiographically exclusion criteria: * • multirooted teeth * teeth undergoing re-endo treatments * teeth with root fractures and/ non restorable determined by clinical and radiographic examination * patients receiving antibiotic treatment in the past 3 months determined by history * patient with diabetes determined by history * patient with history of smoking
lung morphological modifications evaluated by electrical impedance tomography during preoxygenation for the intubation of hypoxemic patients: comparison of standard oxygenation, high flow nasal oxygen therapy, and noninvasive ventilation (morpheit study, an ancillary study of preoniv trial)

Conditions: Adult Patients; Requiring Intubation; Hypoxemia (Defined by PaO2/FiO2( Fraction of Inspired Oxygen) Below 200); Patient Covered by French Health Care System

Summary: prospective, randomized clinical multicentric study, in icu, during preoxygenation for the intubation of hypoxemic patients. electrical impedance tomographic evaluation of lung morphology variations according to the preoxygenation technique : comparison of standard oxygenation, high flow nasal oxygen therapy, and noninvasive ventilation

preoxygenation before endotracheal intubation in the icu is a prerequisite to limit complications, ranging from desaturation, severe hypoxemia and bradycardia with potential cardiac arrest and death. international recommendations suggest the use of non-invasive ventilation (niv) technique whenever possible. high flow nasal cannula (hfnc) has recently gained growing interest in the icu as a treatment of acute respiratory failure, to improve extubation success and as a preoxygenation device before endotracheal intubation. conflicting results have been published. the preoniv study was designed to compare niv, hfnc and conventional preoxygenation with valve bag mask for the preoxygenation before endotracheal intubation. investigator propose to add a lung morphology analysis during preoxygenation. electrical impedance tomography (eit) is a non invasive tool which analyse lung aeration variations via the evolution of local thoracic impedances with electrical loop circulating around a thoracic belt with electrodes. the hypothesis is that the technique of preoxygenation might correlate with oxygen desaturation and potential intubation related complications (preoniv study). moreover lung morphology modifications evaluated by eit might be associated with the preoxygenation technique (morpheit study). investigator wish to asses lung morphological modifications evaluated by eit during preoxygenation in a prospective non blinded randomized fashion.

Eligibility criteria:
inclusion criteria: * • adults patients * requiring intubation and hypoxemia (defined by pao2/fio2 below 200) * patient covered by french health care system * patient included in hopital estaing, clermont-ferrand exclusion criteria: * • patient refusal * intubation for other causes (excluding hypoxemia) * impossibility to measure pulse oxymetry value * contraindication for niv : vomiting * niv intolerance * cardiac arrest during intubation

Keywords: preoxygenation intubation electrical impedance tomography lung aeration alveolar recruitment
modification of allergic immunologic response by leukotriene antagonists - ancillary to acrn impact

Conditions: Asthma; Lung Diseases

Summary: to examine the cellular and molecular mechanisms of corticosteroid and leukotriene receptor antagonists, focusing on their effects on t lymphocytes during both chronic (18 months) and acute therapy.

background: asthma is a chronic inflammatory disease. t lymphocytes are essential for initiating and maintaining the asthmatic inflammatory immune response. corticosteroid treatment targets several inflammatory responses, including t lymphocytemediated responses. in addition, leukotriene receptor antagonists (ltra) may influence t cell activation. to investigate the effects of these two controller agents in the treatment of asthma on airway function is the goal of the impact clinical trial in mild chronic adult asthmatics. the improving asthma control trial (impact) is one of the trials within the nhlbi-supported asthma clinical research network (acrn). impact is a double-blind, randomized, parallel group design clinical trial to determine the best long-term strategy for treating adults with mild asthma who experience symptoms more than occasionally. the trial will test whether these patients should be taking anti-inflammatory medications on a daily basis and whether a newer class of medications provides the same benefit as older drugs. in the impact study, 234 adults with mild asthma who have more than occasional symptoms will be enrolled in six clinical research centers. following an initial evaluation, patients will be randomized to receive either a twice daily inhaled corticosteroid, a twice daily anti-leukotriene, or a placebo. all patients will receive treatment for symptoms if and when they occur. the results should demonstrate whether medication is required on a daily basis by these patients, and if so, whether inhaled corticosteroids and leukotriene modifiers are equally effective. recruitment began in may, 2000. the trial is expected to be completed in 2003. the study is in response to an initiative "ancillary studies in heart, lung, and blood disease trials" released by the national heart, lung, and blood institute in june 2000. design narrative: a total of 39 patients, 13 in each arm, will be randomized to inhaled steroid, leukotriene receptor antagonist or placebo and followed for 18 months for changes in t-cell costimulatory pathways. the study completion date listed in this record was obtained from the "end date" entered in the protocol registration and results system (prs) record.

Eligibility criteria:
no eligibility criteria
change of lumbar symptom after surgical treatment for patients with cervical stenosis

Conditions: Cervical Myelopathy Spondylosis; Low Back Pain

Summary: low back pain may be reduced after cervical spinal surgery

the improved back pain score after cervical spinal surgery would be higher than that after non-surgical treatment.

Eligibility criteria:
inclusion criteria: * all patients with cervical myelopathy and low back pain exclusion criteria: * previous surgery at the lumbar spine * malignancy * previous surgery at the cervical spine
combination chemotherapy with pazopanib in children and adolescents with relapsed/refractory solid tumors

Conditions: Relapsed Pediatric Solid Tumor; Refractory Pediatric Solid Tumor

Summary: the purpose of this study is to evaluate the safety and efficacy of combination chemotherapy with pazopanib in pediatric patients with relapsed/refractory solid tumor


Eligibility criteria:
inclusion criteria: * patients with refractory/relapsed solid tumor (stable or progressive disease after 1st-line treatment or relapse) * patients previously enrolled to "genomic diagnosis of pediatric tumors by ngs (irb no. smc 2015-11-053)" exclusion criteria: * patients who had high-dose chemotherapy and autologous stem cell transplantation previously * patients with organ dysfunction as follows (creatinine elevation ≥ 1.5 x upper limit of normal (uln), ejection fraction \<40%, significant arrhythmia or conduction disturbance) * patients who are not eligible to have scheduled treatment due to the other significant impaired organ function * patients with active bleeding * patients who are taking strong cyp3a4 inhibitors, qtc-prolonging drugs, antithrombotic agents, or anti-platelet agents * pregnant or nursing women * patients who can not swallow the pill
inflammatory markers in saliva of patients with burning mouth syndrome

Conditions: Burning Mouth Syndrome

Summary: burning mouth syndrome (bms) is a chronic pain disorder that presents with inflammation and burning sensation in the oral cavity without visible lesions. multiple therapies have been investigated without conclusive results.objective: to analyse the efficacy of treatment with clonazepam (rivotril) and low power diode laser therapy in patients with burning mouth syndrome and to study the markers of inflammation present in the patients' saliva. methods: randomised, single-blind clinical trial with 89 patients divided into group 1 laser + rivotril (n=20), group 2 laser sham placebo (n=19), group 3 laser (n=21) and group 4 rivotril (n=18). the intensity of symptomatology was rated by visual analogue scale (vas). sialometry was performed before and after treatment and questionnaires such as the xerostomia inventory, the oral health impact profile-14 (ohip14) and the mini-nutritional assessment (mna) were completed. saliva samples were analysed by measuring markers related to inflammatory processes; interleukins (il2, il4, il 5, il6, il 7, il 8, il1β, il 10, il12, il13, il17, il21, il23), proteins (mip-3α, mip-1α, mip-1β), cytokine gm-csf, interferon gamma (ifnγ), interferon inducible tα-cell chemoattractant (itac), fractalkine and tumour necrosis factor α(tnfα).

methods: randomised, single-blind clinical trial with 89 patients divided into group 1 laser + rivotril (n=20), group 2 laser sham placebo (n=19), group 3 laser (n=21) and group 4 rivotril (n=18). the intensity of symptomatology was rated by visual analogue scale (vas). sialometry was performed before and after treatment and questionnaires such as the xerostomia inventory, the oral health impact profile-14 (ohip14) and the mini-nutritional assessment (mna) were completed. saliva samples were analysed by measuring markers related to inflammatory processes; interleukins (il2, il4, il 5, il6, il 7, il 8, il1β, il 10, il12, il13, il17, il21, il23), proteins (mip-3α, mip-1α, mip-1β), cytokine gm-csf, interferon gamma (ifnγ), interferon inducible tα-cell chemoattractant (itac), fractalkine and tumour necrosis factor α(tnfα).

Eligibility criteria:
inclusion criteria: * clinical diagnosis burning mouth syndrome (bms) burning sensation in the oral mucosa or recurrent dysesthetics daily for more than 2 hours a day for more than 3 months, without clinically evident causal lesions exclusion criteria: * pregnant or lactating patients * oncology patients * sjögren's syndrome

Keywords: saliva pain markers
clinical study of genakumab for injection in patients with acute gout

Conditions: Acute Gout

Summary: to evaluate the safety and tolerability of single subcutaneous injection of genakumab for injection in patients with acute gout

phase ib: single arm, open lable, single dose, dose escalation,design. there are 3 dose groups with 10 participant s in each group. phase ii: randomized, double-blind, active control design.there are 2 dose groups of genakumab for injection with 30 participant s in each group and 1 group of compound betamethasone injection with 30 praticipants.

Eligibility criteria:
inclusion criteria: * male or female, 18 years ≤ age ≤65 years * meeting the american college of rheumatology (acr) 2015 preliminary criteria for the classification of acute arthritis of primary gout * contraindication, intolerance or lack of efficacy for nsaids and/or colchicine * body mass index of less than or equal to 45 kg/m2 * onset of current acute gout flare within 5 days prior to study entry * baseline pain intensity ≥ 50 mm on the 0-100 mm visual analog scale (vas) * history of gout flare prior to study entry exclusion criteria: * evidence/suspicion of infectious/septic arthritis, or other acute inflammatory arthritis * presence of severe renal function impairment * use of specified pain relief medications or biologics ( corticosteroids, narcotics, paracetamol/acetominophen, ibuprofen, colchicine, il-blocker, and tumor necrosis factor inhibitor) within specified periods prior to study entry * live vaccinations within 3 months prior to randomization * requirement for administration of antibiotics against latent tuberculosis (tb) * any active or recurrent bacterial, fungal, or viral infection * qtc\>450ms for male, qtc\>470ms for female

Keywords: acute gout