Kornimate/medical-research-clean huggingface dataset:
non interventional study to evaluate the efficacy and tolerability of ectoin containing ophthalmic solution

Conditions: Dry Eye Syndromes

Summary: this is a comparative, open label, parallel group, non interventional study to further demonstrate the efficacy and tolerability of bat04. in addition the efficacy and safety shall be compared to hyaluronic acid (ha)-product. the patient applies bat04 or ha-product according to the instructions for use six times daily in both eyes over a period of 28 days. response to treatment is recorded at day 28.


Eligibility criteria:
inclusion criteria: * male or female person aged 18 years * demonstrated mild to moderate keratoconjunctivitis sicca ( "dry eye") * acute symptoms of dry eye: dews 1-3 * tear break-up time tbut \<10s * agreement to abide by the routinely provided doctor's appointment for follow-up (reflected in the planned visits of observation plan resist) exclusion criteria: * inflammation of the anterior segment or trauma * contact lens wearers * any disease that can, in the opinion of the treating physician to affect the outcome of the study. * patients with known intolerance to one of the substances used * surgical procedures to the eyes in the last 6 weeks before inclusion in the trial * patients with addictive disorders or substance abuse fallow in the past 12 months, as well as persons incapable of giving consent

Keywords: dry eye, sicca, ha, hyaluronic acid, ectoin, ectoine, bitop
ketamine safety and tolerability in psychiatric inpatient care (ketgd)

Conditions: Major Depressive Disorder; Post Traumatic Stress Disorder; Obsessive-Compulsive Disorder; Somatoform Disorders; Anxiety Disorders; Dissociative Disorder

Summary: this observational registry aims to collect real-world data on ketamine use in psychiatric inpatients within a regional tertiary-reference center. the study evaluates the safety and tolerability of ketamine administration in individuals with treatment-resistant mental disorders, characterized by diverse comorbidities, heterogeneous disease courses, and variations in treatment responses based on illness stage and severity with a subset of patients with remitted-recurrent and treatment-resistant or chronic presentations. the registry is designed to systematically document adverse events, side effects, and patient-reported outcomes, providing a comprehensive assessment of both the short- and long-term effects of ketamine in psychopharmacology. by generating real-world evidence, this study shall contribute to a more nuanced understanding of ketamine's risk-benefit profile in clinical practice, particularly in subpopulations that are underrepresented in clinical trials. the findings prioritize the support for the refinement of treatment protocols and enhance patient safety in psychiatric care.


Eligibility criteria:
inclusion criteria: diagnosis as provided by dsm-5 criteria: * major depressive disorder (mdd), * bipolar disorder (bd), * anxiety disorder, * obsessive-compulsive disorder (ocd), * somatoform disorder, * post-traumatic stress disorder (ptsd), * dissociative disorder exclusion criteria: * pregnancy and lactation * hypersensitivity to ketamine * uncontrolled hypertension * other uncontrolled somatic diseases that may impact safety per the investigator's judgment
walnut oral immunotherapy for tree nut allergy

Conditions: Nut Hypersensitivities

Summary: the purpose of this study is to determine if walnut oral immunotherapy can be used in subjects allergic to tree nuts to decrease their tree nut allergy and induce changes in their immune system.

tree nut

Eligibility criteria:
inclusion criteria: * age 6 to 45 years, either sex, any race, any ethnicity with a convincing clinical history of walnut or another tree nut allergy and either a positive prick skin test (\> 3mm) or serologic evidence of allergic sensitization (defined as specific ige \> 0.35 ku/l) to walnut and at least one other tree nut. * a positive 2000 mg oral food challenge at enrollment to walnut and to one other tree nut. * written informed consent from participant and/or parent/guardian * written assent from all subjects as appropriate * all females of child bearing age must be using appropriate birth control exclusion criteria: * history of severe anaphylaxis to walnut or other tree nuts, defined as symptoms associated with hypoxia, hypotension or neurologic compromise (cyanosis or spo2 \< 92% at any stage, hypotension, confusion, collapse, loss of consciousness; or incontinence). * known allergy to oat * chronic disease (other than asthma, atopic dermatitis, rhinitis) requiring therapy or other respiratory or medical conditions deemed by the investigator to put the subject at increased risk of anaphylaxis or poor outcomes from receiving oit or undergoing food challenge. * poor control or persistent activation of atopic dermatitis * active eosinophilic or other inflammatory (e.g., celiac) gastrointestinal disease in the past 2 years. * participation in any interventional study for food allergy in the past 6 months * participant is on "build-up phase" of immunotherapy (i.e., has not reached maintenance dosing). * severe asthma (2007 nhlbi criteria steps 5 or 6, see appendix 2) or poorly controlled mild or moderate asthma * inability to discontinue antihistamines for initial day escalation, skin testing or ofc * use of omalizumab or other non-traditional forms of allergen immunotherapy (e.g., oral or sublingual) or immunomodulator therapy (not including corticosteroids) or biologic therapy within the past year * use of beta-blockers (oral), angiotensin-converting enzyme (ace) inhibitors, angiotensin-receptor blockers (arb) or calcium channel blockers * pregnancy or lactation

Keywords: walnut hypersensitivity tree nut hypersensitivity
vildagliptin add-on to glimepiride versus placebo added to glimepiride in type 2 diabetes

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to demonstrate the efficacy and safety of vildagliptin 50mg qd as add-on therapy to sulfonylurea in patients with type 2 diabetes inadequately controlled with prior sulfonylurea monotherapy as compared to placebo. this study is aimed at supporting the regulatory approval in china of vildagliptin as combination therapy with sulfonylureas in the treatment of type 2 diabetes.


Eligibility criteria:
inclusion criteria: 1. confirmed diagnosis of t2dm by standard criteria 2. patients who have received a stable dose of su for at least 12 weeks prior to visit 1 3. hba1c ≥7.5% to ≤ 11.0% at visit 1 and visit 3 (week -1) 4. age: ≥18 to ≤ 80 years at visit 1. 5. bmi ≥ 20 and ≤ 40 kg/m\^2 at visit 1. exclusion criteria: 1. fpg ≥ 270mg/dl (15.0 mmol/l) at visit 1 or visit 3 (week -1) 2. severe or repetitive hypoglycemia, as defined in section 3.1, during the run-in period (between visit 2 and visit 4) other protocol-defined inclusion/exclusion criteria may apply

Keywords: diabetes mellitus vildagliptin
study comparing weekly taxol and carboplatin vs standard taxol and carboplatin regimen for stage iiib or iv non-small-cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: taxol and carboplatin are commonly used drugs for the treatment of stage iiib or iv non small cell lung carcinoma. this study compares treatment with taxol/carboplatin given every 3 weeks to a schedule where it is given weekly. the purpose of the study is to determine the most effective and safe schedule for giving these drugs in non small cell lung carcinoma.


Eligibility criteria:
inclusion criteria: * confirmation of non-small cell bronchogenic carcinoma (epidermoid, squamous, adeno, large cell anaplastic carcinoma, but no small cell or carcinoid) must be histologically or cytologically confirmed. * no prior antineoplastic chemotherapy, hormonal therapy or therapy with biological response modifiers * no previous irradiation to the only area of measurable disease. exclusion criteria: * past or current history of neoplasm other than the entry diagnosis. exceptions are curatively treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix or other cancers treated by surgery or radiation with a disease free survival longer than 5 years. * patients who have undergone surgery less than 3 weeks prior to enrollment. * history of serious cardiac disease not adequately controlled. * patients with serious active infections or other serious underlying medical condition. * uncontrolled diabetes mellitis.
clinical study of the third dose immunization schedule of covid-19 inactivated vaccine, (vero cells) based on different covid-19 inactivated vaccine in adults aged 18 years and above

Conditions: SARS-CoV-2 Infection

Summary: to evaluate the immunogenicity and safety of the third dose sars-cov-2 vaccine, inactivated (vero cell) in adults aged 18 years and above, who inoculated the third dose after 3, 4, 5, or 6 months since finished two doses schedule of coronavac or bbibp-corv.


Eligibility criteria:
inclusion criteria: 1. axillary temperature ≤37.0 ℃. 2. aged 18 years and above, after 3, 4, 5, or 6 months since finished two doses schedule of coronavac or bbibp-corv, or one does coronavac and one does bbibp-corv. 3. proven legal identity, could come each visit. 4. participants should understand the contents of the informed consent form, the vaccine in this trial, voluntarily sign the informed consent form. exclusion criteria: 1. persons with a clear history of sars-cov-2 infection. 2. using blood products after basic immunization or receiving immunosuppressive therapy. 3. participants who have a positive pregnancy test, or are breastfeeding, or plan to become pregnant, or plan to donate sperm or eggs from the screening to 6 months after vaccination. 4. allergic to the active substance in the vaccine, any inactive substance or substance used in the preparation process (aluminum hydroxide, glycine); 5. history of abnormal clinical manifestations and serious diseases to be excluded, including but not limited to nervous system, cardiovascular system, blood and lymphatic system, immune system, kidney, liver, gastrointestinal tract, respiratory system, metabolism, bones and other system diseases, and a history of malignant tumors. 6. diseases beyond drug control, such as high blood pressure, diabetes, asthma. 7. those who developed acute disease within 2 weeks, or had symptoms of fever or upper respiratory tract infection within 7 days. 8. immunization with any vaccine within 14 days. 9. any other situations judged by investigators as not suitable for participating in this study.
impact of intravascular ultrasound(ivus)-guided chronic total occlusion intervention with drug-eluting stents

Conditions: Coronary Artery Disease

Summary: guidance of stenting by ivus has been proposed as a method to reduce restenosis rates, because lumen and stent dimensions can be accurately determined by intravascular ultrasound (ivus).

guidance of stenting by ivus has been proposed as a method to reduce restenosis rates, because lumen and stent dimensions can be accurately determined by intravascular ultrasound (ivus). however, randomized studies investigating this strategy have yielded inconsistent results. therefore, the investigators hypothesized that the potential advantages of ivus guidance would be most apparent in chronic total occlusion (cto) intervention and try to evaluate the impact of ivus-guided chronic total occlusion intervention with drug-eluting stents on mid-term angiographic, ivus and clinical outcomes.

Eligibility criteria:
inclusion criteria: 1. patient is ≥ 20 years or ≤ 80 years old 2. on coronary angiography, complete obstruction of coronary blood flow (timi grade 0) with estimated occlusion duration ≥ 3months. 3. on coronary angiography, reference vessel diameter of 2.5 to 4.0mm by operator assessment 4. on coronary angiography, total length of total occluded lesion and main lesion is less than 80mm and lesions can be treated less than 4 stents. 5. guide wire can be passed through occluded lesion without complications 6. patients who can keep the dual antiplatelet treatment (aspirin, clopidogrel) more than 6 months after procedure exclusion criteria: 1. hypersensitivity reaction or side effects to aspirin, clopidogrel, biolimus a9 and zotarolimus 2. unprotected left main disease 3. cardiogenic shock or lv ejection fraction ≤ 30% 4. previous stent restenotic lesion 5. treated within 2 weeks at the same lesion. 6. creatinine level ≥ 2.0 mg/dl or esrd 7. severe tortuous and calcified lesion (unobtainable ivus image) 8. life expectancy \< 1 year 9. severe hepatic dysfunction (3 times normal reference values) 10. pregnant women or women with potential childbearing
safety and efficacy of sbrt in the treatment of thoracic malignant tumors at different sites

Conditions: Radiotherapy; Thoracic Cancer; Safety and Efficacy

Summary: sbrt (stereotactic radiotherapy) can provide a higher dose to the target area without increasing the risk of surrounding normal tissue / organ injury in selective cases. at present, sbrt has been widely used in radiotherapy of lung cancer and it can also play a better local control for lung metastasis. however, there are parallel organs and series organs in the chest, and different organs have different tolerance to radiotherapy, so the toxicities of sbrt in different sites are different, and the prescription dose is also different. this study intends to make a detailed division of the chest region and explore the safety and efficacy of sbrt in different areas. it is divided into four types: chest wall type: the lesion is directly adjacent or overlapped with the chest wall; peripheral type: the lesion is more than 1cm away from the chest wall and more than 2cm away from the bronchial tree; central type: the lesion is less than 2cm away from the bronchial tree; ultral-central type: the lesion is directly adjacent or overlapped with the mediastinal structure. 48-60gy / 4-10f (eqd2 = 62.5gy \~ 99.7gy) was given according to the location of the tumor. main outcome measures are local progression free survival and radiation toxicities; secondary outcome measure is overall survival.


Eligibility criteria:
inclusion criteria: * pathological diagnosis was malignant tumor. * the location of the target lesion belongs to one of five types and the lesion diameter is ≤ 5cm. * there is no extensive systemic metastasis or although there is metastasis, the metastasis have been controlled by previous treatment. * kps\>70, no serious or uncontrolled underlying diseases, such as severe or uncontrolled hypertension, diabetes, cardiovascular and cerebrovascular diseases and organ dysfunction, and patients are expected to be tolerated by radiotherapy. exclusion criteria: * poor basic pulmonary function or symptom correlation caused by various reasons, unable to lie flat or cooperate with treatment. * the general condition is poor, and the expected survival time is less than 3 months. * psychiatric patients or poor compliance, unable to cooperate to complete treatment. * for other reasons, the researcher believes that it is not suitable to participate in this trial.
effects of a psycho-cognitive nursing intervention on patients' outcomes in critical illness

Conditions: Critical Illness; Stress; Inflammatory Response

Summary: the purpose of this study is to investigate whether a psycho-cognitive nursing intervention including relaxation, guided imagery, touch and music listening can improve the clinical and psychological outcome of critically ill patients. the investigators hypothesize that, patients who receive the proposed psycho-cognitive nursing intervention will report lower stress, less pain and have altered level of stress neuropeptides in peripheral blood, lower levels of inflammatory molecules, less complications and better self reported lived experience than patients who receive standard care alone.

in previous research on the impact of stress on physiology, it has been shown that stress and its molecules may contribute to derangements prevalent in critical illness, including systemic inflammation, cellular stress, oxidative damage, endothelial dysfunction and coagulopathies which precipitate high mortality and morbidity. investigators will examine whether a psycho-cognitive nursing intervention to induce relaxation can improve patients outcomes. sixty icu patients with or without sirs will be randomized to receive either standard care or a brief psycho-cognitive nursing intervention, plus standard care, up to 5 days during icu stay.

Eligibility criteria:
inclusion criteria: * critically ill patients * understand greek language * age over 18 years * they have richmond agitation sedation scale rate: -3 +3 * have an arterial line in place exclusion criteria: * patient who is expected to stay less than 24 hours in critical care unit * have history of psychiatric disturbances * their condition does not permit use of headphones * have hearing impairment * receive neuro-muscular blockers * are confused * patients under universal conduct precautions

Keywords: critical illness intervention rct relaxation guided imagery touch/massage music listening neuropeptides inflammatory molecules post-traumatic stress critical care nurse psychocognitive nursing intervention interpersonal support
safety and efficacy of persistent atrial fibrillation ablation with a cryoballoon technology

Conditions: Atrial Fibrillation

Summary: the goal of this retrospective observational study is to learn about the safety and efficacy of cryoballoon catheter ablation in 80 patients with persistent atrial fibrillation using the polarx (boston scientific) cryoablation technology. the main question it aims to answer is if it is safe and effective.


Eligibility criteria:
inclusion criteria: * persistent atrial fibrillation patients undergoing first atrial fibrillation ablation procedure with polarx cryoballoon exclusion criteria: * previous atrial fibrillation ablation or cardiac surgery, * paroxysmal atrial fibrillation, * congenital heart disease, * non-treated coronary artery disease, * intracavitary thrombus, * significant valvular disease, * contraindications to general anesthesia.
chinese research group of gallbladder cancer

Conditions: Gallbladder Neoplasms

Summary: the chinese research group of gallbladder cancer (crggc) is a retrospective multicenter registry cohort, collecting electronic medical records of patients diagnosed with gallbladder cancer from hospitals in collaboration.

the objectives of the crggc are as follows: 1. to study the current diagnosis and treatment of gallbladder cancer in china. 2. to clarify the prognostic role of debated risk factors associated with gallbladder cancer. 3. to improve the accurate staging of gallbladder cancer. 4. to standardize the treatment with gallbladder cancer.

Eligibility criteria:
inclusion criteria: * patients with at least clinical diagnosis of gallbladder cancer, including c23.9 and part of c24.0 (cystic duct cancer). * patients with accessible electronic medical record exclusion criteria: * patients with undetermined primary site of cancer.

Keywords: gallbladder neoplasms gallbladder cancer
a research study to compare two semaglutide medicines in people with type 2 diabetes

Conditions: Diabetes Mellitus, Type 2

Summary: the study compares two semaglutide medicines and looks at how well they control blood sugar levels, in participants with type 2 diabetes (t2d). participants will either get the currently available semaglutide or the semaglutide which is produced through a new manufacturing process. participants need to take one injection of semaglutide once a week, on the same day of every week. participants will have a total of 11 clinic visits and the study will last for about 35 weeks (approximately 8 months).


Eligibility criteria:
inclusion criteria: * diagnosed with type 2 diabetes (t2d) mellitus greater than equal to (≥) 180 days before screening. * stable daily dose(s) ≥ 90 days prior to the day of screening of metformin ≥ 1500 milligrams (mg) or maximum tolerated or effective dose. * hba1c of 7.0-10.5 percentage (%) \[53-91.3 millimoles per mole (mmol/mol)\] (both inclusive). exclusion criteria: * known or suspected hypersensitivity to study intervention(s) or related products. * treatment with any medication for the indication of diabetes or obesity other than stated in the inclusion criteria within 90 days before screening. however, short term insulin treatment for a maximum of 14 days and prior insulin treatment for gestational diabetes are allowed. * uncontrolled and potentially unstable diabetic retinopathy or maculopathy. verified by a fundus examination performed within 90 days before screening or in the period between screening and randomisation. pharmacological pupil-dilation is a requirement unless using a digital fundus photography camera specified for nondilated examination.
self-management in african americans with diabetes and hypertension

Conditions: Diabetes

Summary: the primary aim of the study is to design a group-based, culturally appropriate self-management skills training intervention for disadvantaged african-americans with both diabetes and hypertension and to compile an intervention manual of operations (moo). the investigators are developing an intervention to assist individuals in reducing weight and hemoglobin a1c.


Eligibility criteria:
inclusion criteria: * diagnosis of type 2 diabetes mellitus (hga1c\>7%), requiring the patient to take at least one tablet per day or one insulin injection per day and a diagnosis of hypertension (130/80) requiring them to take at least one medication per day; * participants must identify themselves as african-american; * participant resides in or proximal to the north lawndale neighborhood; * secure written permission from their physician to engage in moderate physical activity. this set of participants may be at high risk for cardiac disease and this exclusion avoids putting them at undue risk; * bmi ≥ 25. participant must be overweight because the main goal of our intervention is weight loss of 5% or more of initial body weight. exclusion criteria: * diet-controlled diabetes; * hypertension controlled with lifestyle modification only; * endstage renal disease, stroke with paresis, congestive heart failure (nyha class 3 or 4), or other major endorgan complication of diabetes; * comorbid conditions limiting probable life span to \<4 years (e.g. cancer, aids) or indication of end-stage complications of diabetes (kidney dialysis, or transplant, blindness, or lower extremity amputation); * receiving treatment for a major psychiatric disorder (i.e. schizophrenia); * unable to give informed consent; * are under the age of 18-while type-2 diabetes and hypertension are increasing in those under the age of 18, adolescent medicine is a separate specialty area from adult medicine. interventions should be targeted specifically toward this age group to take into consideration the specific emotional and psychological needs of adolescents; * alcoholism as measured by the cage.screener for alcohol abuse.