Kornimate/medical-research-clean huggingface dataset:
impact of diazepam 1% oral gel efficacy in burning mouth syndrome

Conditions: Burning Mouth Syndrome

Summary: burning mouth syndrome (bms) is a syndrome characterized by burning and persistent oral pain, ranging from mild to intense, in the absence of organic disorders of the oral cavity and with a major impact on the quality of life of the sufferer. although several etiological theories have been proposed to explain bms, none has been universally accepted to date, and its origin remains unclear. currently, several scientific evidences would suggest that underlying bms would be alterations in certain neuropathic mechanisms. the purpose of the study is to evaluate the efficacy of diazepam 1% oral gel in the treatment of burning mouth syndrome.

a double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of diazepam 1% oral gel and determine the statistical significance of the outcome variables. 40 patients with bms, in two groups: * case group with diazepam 1% oral gel (galenic formulation) * control group with placebo in oral gel formulation follow-up of 2 months

Eligibility criteria:
inclusion criteria: * clinically diagnosed with bms who reported a history of continuous oral burning pain for more than 4 months with no clinical signs that could justify the syndrome exclusion criteria: * • clinically diagnosed with bms who reported a history of continuous oral burning pain for more than 4 months with clinical signs that could justify the syndrome
single escalating dose study of hsk7653 in healthy subjects

Conditions: T2DM (Type 2 Diabetes Mellitus)

Summary: to evaluate the safety, tolerability, pharmacokinetic (pk) and pharmacodynamic (pd) characteristics of single dose of hsk7653 tablets in healthy adult subjects, and to identify the metabolites of hsk7653 in healthy adult subjects


Eligibility criteria:
inclusion criteria: * age ≥18 and age ≤60 years * bmi ≥18 and bmi ≤ 25 kg/m2 (body mass index) * able to understand the procedures of the study, provide written informed consent, and be willing to comply with the protocol of the study exclusion criteria: * any finding of the medical examination (physical examination, laboratory examination, 12-ecg, abdominal b-ultrasonography, etc) deviating from normal and of clinical relevance during screening * evidence or history of clinically significant renal, gastrointestinal (including pancreatitis), hepatic disease at the time of screening * has a positive result on screening for serum hepatitis b surface antigen (hbsag), hepatitis c antibody (hcvab), treponema pallidum antibody (tp-ab) or human immunodeficiency virus (hiv) * treatment with an investigational drug within 3 months * fertile male subjects who are unwilling or unable to use a highly effective method of contraception for the duration of the study and for at least 6 months after the last dose
compaction total hip arthroplasty (tha) bilateral

Conditions: Coxarthrosis

Summary: this is a prospective, randomized study comparing two different bone preparation techniques for insertion of a porous coated titanium cementless femoral stem. patients receiving a bilateral total hip replacement are randomized to conventional broaching on one side and compaction on the other side. hypothesis: compaction results in significantly less stem migration \[evaluated by radiostereometric analysis (rsa)\], less peri-prosthetic bone mineral density (bmd) loss \[evaluated by dual energy x-ray absorptiometry (dexa)\], and a higher harris hip score after two years.


Eligibility criteria:
inclusion criteria: * patients with primary arthritis in the hip * patients with sufficient bone density to allow uncemented implantation of a femoral component * informed patient consent in writing exclusion criteria: * patients with neuromuscular or vascular disease in the affected leg * patients found upon operation to be unsuited for uncemented acetabulum component * patients who regularly take non-steroidal anti-inflammatory drugs (nsaids) and cannot interrupt intake for the postoperative phase of the study * patients with fracture sequelae * female patients of childbearing capacity * hip joint dysplasia * sequelae to previous hip joint disorder in childhood.

Keywords: tha
evaluation of clinical treatment of multiple myeloma based on multi-omics

Conditions: Multiple Myeloma; Bortezomib

Summary: with the emergence of new drugs, the short-term survival rate of multiple myeloma has been significantly increased. however, in clinical treatment, doctors found that different patients may present different clinical efficacy and adverse reactions when using standard treatment. some studies have shown that gene and metabolic differences in patients with multiple myeloma may be an important factor affecting clinical efficacy. in this project, peripheral blood samples and bone marrow from patients with multiple myeloma will be studied by using the methods of genomics, proteomics, metabonomics and transcriptomics. it is expected to find biomarkers and genes related to clinical efficacy, adverse reactions, and blood concentration of bortezomib in peripheral blood samples. if the sample size is large enough, the project team expects to establish a prediction model for the efficacy and safety of bortezomib containing regimen for multiple myeloma patients through the above studies. investigators hope that the evaluation system can provide a reference for clinical formulation of appropriate drug delivery scheme.


Eligibility criteria:
inclusion criteria: * exposure group: 1. patients diagnosed with multiple myeloma. 2. patients with fluorescence in situ hybridization report results, and try to obtain genetic diagnosis results. * healthy control group: patients diagnosed without multiple myeloma, such as other chronic diseases or blood tumors. exclusion criteria: 1. patients without complete clinical information. 2. patients with malignant epidemic diseases. 3. patients with alcohol abuse or special dietary habit . 4. patients with digestive system diseases, such as inflammatory bowel disease, intestinal infectious disease or other diseases that may affect digestive system function. 5. patients with a history of gastrointestinal operation. 6. patients with severe renal insufficiency without regular dialysis. 7. patients with other possibilities who has severe liver or kidney function injury without intervention.

Keywords: genomics metabonomics therapeutic drug monitoring
efficacy and safety of ranibizumab (intravitreal injections) in patients with visual impairment due to diabetic macular edema

Conditions: Diabetic Macular Edema

Summary: this study was designed to confirm the efficacy and safety of ranibizumab (0.5 mg) as adjunctive therapy when added to laser photocoagulation and/or as monotherapy in asian patients with visual impairment due to diabetic macular edema (dme).


Eligibility criteria:
inclusion criteria: * patients with type 1 or type 2 diabetes mellitus according to american diabetes association (ada) or world health organization (who) guidelines with hba1c not more than 10.0% at screening (visit 1). patients should be on diet, exercise, and/or pharmacological treatment for diabetes. * patients with visual impairment due to focal or diffuse diabetic macular edema in at least one eye who are eligible for laser treatment in the opinion of the investigator. if both eyes are eligible, the one with the worse visual acuity, as assessed at visit 1, will be selected for study treatment unless, based on medical reasons, the investigator deems the other eye the more appropriate candidate for study treatment. * the study eye must fulfill the following criteria at visit 1: * best-corrected visual acuity (bcva) score between 78 and 39 letters, inclusively, using early treatment of diabetic retinopathy (etdrs) chart-like visual acuity testing charts at a testing distance of 4 meters (approximate snellen equivalent of 20/32 to 20/160). * decrease in vision is due to dme and not due to other causes, in the opinion of the investigator. * medication for the management of diabetes must have been stable within 3 months prior to randomization and is expected to remain stable during the course of the study. exclusion criteria: * ocular concomitant conditions/ diseases: * concomitant conditions in the study eye which could, in the opinion of the investigator, prevent the improvement of visual acuity on study treatment. * active intraocular inflammation in either eye. * any active infection in either eye. * history of uveitis in either eye. * uncontrolled glaucoma in either eye. * ocular treatments: * panretinal laser photocoagulation in the study eye within 6 months prior to or during the study. * focal/grid laser photocoagulation in the study eye within 3 months prior to study entry. * systemic conditions or treatments: * history of stroke * renal failure requiring dialysis or renal transplant or renal insufficiency with creatinine level \> 2.0 mg/dl. * untreated diabetes mellitus * blood pressure systolic \> 160 mmhg or diastolic \> 100 mmhg * compliance/ administrative: * pregnant or nursing (lactating) women other protocol-defined inclusion/exclusion criteria may apply

Keywords: dme diabetic macula edema ranibizumab reveal
radial-probe endobronchial ultrasound in detecting atelectasis in patients undergoing peripheral bronchoscopy

Conditions: Malignant Neoplasms of Respiratory and Intrathoracic Organs; Lung Neoplasm

Summary: this trial studies how well radial-probe endobronchial ultrasound works in detecting the complete or partial collapse of the lung in patients undergoing peripheral bronchoscopy. diagnostic procedures, such as radial-probe endobronchial ultrasound and bronchoscopy, use a thin, tube-like instrument inserted through the nose or mouth to view and take pictures of the inside of the trachea, air passages, and lungs.

primary objectives: i. to estimate the proportion of patients identified as developing intraprocedural atelectasis detected by radial-probe endobronchial ultrasound (rp-ebus) during peripheral bronchoscopy under general anesthesia. secondary objectives: i. to describe the most common locations for developing intraprocedural atelectasis detected by rp-ebus. ii. to describe the proportion of evaluated bronchial segments per patient that are identified as developing intraprocedural atelectasis by rp-ebus. iii. to identify patient and procedural characteristics that may predispose to the development of atelectasis. outline: patients undergo bronchoscopy per standard of care, rp-ebus of the left and right lungs during bronchoscopy procedure, and rp-imaging over 3-5 minutes at the end of the bronchoscopy procedure.

Eligibility criteria:
inclusion criteria: * patients undergoing bronchoscopy with radial ebus for peripheral lung lesions * recent computed tomography (ct) performed no more than 4 weeks prior to the bronchoscopy * voluntary informed consent to participate in the study exclusion criteria: * patients with baseline lung consolidation, interstitial changes or lung masses (\> 3 cm in diameter) in dependent areas of the lung as seen on most recent ct * pregnancy * ascites * known diaphragmatic paralysis

Keywords: malignant neoplasms of respiratory and intrathoracic organs endobronchial ultrasound-guided transbronchial needle aspiration ebus-tbna
tobacco treatment in the context of lung cancer screening

Conditions: Smoking Cessation

Summary: the proposed study will test a medication plus text messaging intervention specifically designed for lung cancer screening patients. half of the patients will receive standard of care, and half will receive the treatment intervention.

screening for lung cancer at earlier, more treatable stages has the potential to reduce mortality from the u.s.'s most deadly cancer. annual lung cancer screening with low-dose computed tomography is now recommended for high risk individuals based on age and smoking history. this study will evaluate a smoking cessation intervention for lung cancer screening patients. we will evaluate quit rates after a standard intervention (brief counseling session at time of lung cancer screening) versus a dual nicotine replacement therapy (nrt) and gain-framed text messaging intervention.

Eligibility criteria:
inclusion: 1. 55 years or older 2. 30 pack year history of smoking 3. current smoker (defined as breath carbon monoxide\>6ppm) 4. willing to be randomized 5. english speaking exclusion: 1. unstable psychiatric/medical conditions such as suicidal ideation, acute psychosis, severe alcohol dependence, substance abuse, or dementia 2. in the immediate (within 2 weeks) post myocardial infarction period 3. serious arrhythmias 4. unstable angina pectoris 5. hemodynamically or electrically unstable 6. currently taking part in any other tobacco treatment program or using cessation medication (i.e., taking nrt or other cessation medications, enrolled in the quitline, in another drug study).
the role of il-22/il-22bp axis in atopic dermatitis

Conditions: Atopic Dermatitis

Summary: interleukin 22 (il-22) is known to be regulated by il-22 binding protein (il-22bp), a soluble, inhibitory receptor. the potential role of il-22bp in atopic dermatitis (ad) is mostly unknown and deserves further investigation. the main objective of this study is to better understand the potential protective role of il-22bp through the assessment of its expression at the messenger ribonucleic acid (mrna) and protein levels in skin and serum which will be correlated to the severity of the diseases and through the identification of its cellular sources in lesions. the results of this study will help to correctly interpret the levels of il-22 in ad and will potentially allow identifying biomarkers for patient stratification and predicting clinical outcomes to targeted therapeutic agents.

this is a single-visit study. all patients will have a blood sample and 2 skin biopsies (2 mm diameter) in lesional and non lesional area . it is planned to include 45 patients (15 patients per severity group: scorad \]25-50\] , \]50-65\]; 50-65; \>65).the first 20 patients included will be group 2 and 3 patients (scorad \> 50). the patients will be adults with ad recruited from the cohort of patients followed up in the dermatology department of nantes university hospital. a refusal rate of 4/5 is expected. recruitment can therefore be envisaged in 18 months (2.5 patients/month). patients will be recruited during follow-up consultations or at the first consultation in the department. recruitment will be coordinated by the clinical research team (crt). blood samples will be taken by the crt nurse. the skin and blood samples will be sent to the cimna/ immunology laboratory nantes university hospital

Eligibility criteria:
inclusion criteria: * patients with ad according to uk working party criteria * patients affiliated to french social security system * patients who gave written consent after reading the protocol * moderate to severe ad (scorad score\>25) * presence of at least one lesional and one non-lesional skin area in the area covered by the clothing * no immunosuppressive systemic treatment in progress for at least 3 months or biologics for at least 4 months exclusion criteria: * minor patients * pregnant and/or breastfeeding women * patients under guardianship or tutorship * inability to understand information and instructions * patients undergoing systemic immunosuppressive treatment for at least 3 months or biologics for at least 4 months * patient included in a clinical trial * documented allergy to the anesthetic (xylocain)

Keywords: atopic dermatitis eczema interleukin 22
effect of dexmedetomidine in preventing cough and postoperative pain after laryngeal surgery for cancer

Conditions: Laryngectomy; Status

Summary: background: during emergence from anesthesia for partial and total laryngectomy, severe airway reflex and systemic hypertension during recovery may lead to pneumoderm, hemorrhage, pneumomediastinum or pneumothorax. dexmedetomidine is a selective α2-adrenoreceptor agonist that has sedative, analgesic, and sympatholytic properties. it has been reported dexmedetomidine can attenuate coughing reflex and prevent emergence agitation without delaying recovery and respiratory depression from general anesthesia. the purpose of this study was to investigate the effect of dexmedetomidine compared with midazolam on cough suppression and recovery quality during emergence from general anesthesia after partial and total laryngectomy. methods american society of anesthesiologists physical status i-ii male adults undergoing elective laryngectomy under sevoflurane anesthesia were recruiting and randomly allocated to receive either dexmedetomidine(group d, n = 60) infusion at 0.5 µg•kg-1 for 10 min before tracheotomy, then adjusted to 0.3µg•kg-1•h-1 or midazolam (group m, n = 60) infusion at 0.05 mg•kg-1 ten minutes before tracheotomy, then adjusted to 0.02mg•kg-1•h-1. the primary outcome measure was the incidence and severity of cough. hemodynamics, pain intensity \[visual analogue scale (vas)\] and ramsay sedation scale (rss) were also evaluated at awake, patients returning to ward from post anesthesia care unit (pacu),2h after surgery. postoperative sufentanil consumption, recovery time and the incidence of concerning adverse effects were recorded.


Eligibility criteria:
inclusion criteria: subject scheduled for partial or total laryngectomy. exclusion criteria: subject has respiratory disease; subject has pharyngeal paraganglioma; subject has cardiac disease; uncontrolled hypertension; subject has been taking β-adrenoreceptor blockers; long-term abuse of alcohol (\>6 months),opioids, or sedative-hypnotic drugs; allergic to dexmedetomidine or midazolam; subject has neuropsychiatric diseases; operation time shorter than 1 h or longer than 4 h.

Keywords: dexmedetomidine midazolam cough sedation pain
a phase iii clinical study comparing js004 plus toripalimab with investigator-selected chemotherapy in patients with pd-(l)1monoclonal antibody refractory classic hodgkin lymphoma (chl)

Conditions: Hodgkin Lymphoma

Summary: the study is being conducted to compare js004 plus toripalimab with investigator-selected chemotherapy in patients with pd-(l)1 monoclonal antibody refractory classic hodgkin lymphoma (chl)

the study is a randomized, open-label, phase iii clinical trial. the main objective is to compare the efficacy of js004 plus toripalimab with investigator-selected chemotherapy in treating patients with pd-(l)1 monoclonal antibody refractory classic hodgkin lymphoma (chl). the study will assess the safety and tolerability of js004 combined with toripalimab.

Eligibility criteria:
inclusion criteria: patients must meet all of the following inclusion criteria to be enrolled: * age at least 18 years old, both males and females are eligible * pathologically confirmed classical hodgkin lymphoma (chl) with either relapsed (disease progression after achieving cr/pr in recent treatment) or refractory (failure to achieve cr/pr in recent treatment) status. * has exhausted all standard treatment and refractory to pd-(l)1 monoclonal antibody (mab) * ecog: 0-2 * at least one measurable lesion meeting the criteria specified in the lugano 2014 response assessment. exclusion criteria: * known allergy or contraindication to the investigational drug or its components * permanent discontinuation of anti-pd-(l)1 antibody due to immune-related adverse reactions. * presence of central nervous system (cns) metastasis. * presence of pleural effusion, ascites, or pericardial effusion requiring intervention (e.g., aspiration, drainage) * active autoimmune diseases requiring systemic treatment (such as corticosteroids or immunosuppressive drugs) within the past 2 years
dose response of pursed lip breathing with diaphragmatic breathing on pulmonary functions in patients with copd

Conditions: COPD

Summary: 1. to determine the effects of combined pursed lip breathing with diaphragmatic breathing on pulmonary functions in patient with copd. 2. to determine the different durations of combined pursed lip breathing with diaphragmatic breathing on pulmonary functions in patient with copd. 3. to determine the effects of combined pursed lip breathing with diaphragmatic breathing on quality of life in patient with copd

the technique of pursed lip breathing allow the patients to control the oxygenation and ventilation. this technique is performed by allowing the person to inspire through the nose exhale through the mouth at a slow controlled flow. this technique works by moving oxygen into your lungs and carbon dioxide out of your lungs. pursed lip breathing (plb) helps to slow down breathing rate and relieving shortness of breath by keeping the airways open longer. so patients can remove the air that is trapped in to the lungs. in a recent systematic review that is published in 2018, plb was shown to significantly improve ventilation related outcomes such as respiratory rate and minute ventilation, but not dyspnea and exercise capacity. diaphragmatic breathing (db), that is also called deep breathing, this breathing is done by contracting the diaphragm, a muscle located horizontally between the thoracic cavity and abdominal cavity. during this type of breathing, air enters in to the lungs, the chest does not rise and belly expands. diaphragmatic breathing encourages fully oxygen exchange, that is the beneficial trade of incoming oxygen for out going carbon dioxide.

Eligibility criteria:
inclusion criteria: * participants were diagnosed as copd * the intervention plb combine with db * stable copd patients (mild and moderate on gold criteria) global initiative for chronic obstructive lung disease (gold) exclusion criteria: * patients with other pulmonary diseases. * cardiovascular, neurological and orthopedic diseases * obesity, history of recent exacerbation * uncontrolled arterial hypertension * any surgical complications * patients with ventilatory support
risk assessment for progression to dmek following cataract surgery in fuchs endothelial corneal dystrophy

Conditions: Fuchs' Endothelial Dystrophy; Cataract

Summary: justification. fuchs' corneal endothelial dystrophy (fecd) is one of the main causes of corneal transplantation. in many cases, the corneal decompensation derived from this dystrophy is triggered as a consequence of cataract surgery, so the dilemma of facing isolated cataract surgery or combined with endothelial keratoplasty is often raised. objective. the present study aims to evaluate and select the most important predictive factors for corneal decompensation after cataract surgery in patients with fecd. method. prospective observational study of the preoperative and intraoperative variables presumably associated with postoperative corneal edema requiring descemet stripping endothelial keratoplasty (dmek). consecutive candidates for cataract surgery with fecd will be selected and anterior segment imaging will be performed, along with a complete ophthalmological examination. clinical, pachymetric, tmographic, densitometric, specular microscopy, and intraoperative variables will be registered.


Eligibility criteria:
inclusion criteria: * fecd grade 2 or worse (modified krachmer scale) * cataract requiring surgery * epithelial corneal edema evident in slit lamp examination exclusion criteria: * concurrent anterior corneal dystrophy * history of ocular trauma, ocular surgery, previous ocular inflammation or infection,uncotroled glaucoma, amblyopia, neovascular age-related macular degeneration, or active vacular retinal disease. * non-collaborative or unable to receive postoperative care at our institution.