Kornimate/medical-research-clean huggingface dataset:
brexpiprazole as combination therapy with sertraline in treatment of adults with ptsd

Conditions: Post Traumatic Stress Disorder

Summary: this will be a 12-week, multicenter, randomized, double-blind trial evaluating the efficacy, safety, and tolerability of brexpiprazole + sertraline combination treatment in adult participants with post-traumatic stress disorder.


Eligibility criteria:
inclusion criteria: * male and female outpatients 18 to 65 years of age, inclusive, at the time of informed consent. * participants who have ptsd, diagnosed according to the diagnostic and statistical manual of mental disorders, 5th edition (dsm-5), and confirmed by the mini international neuropsychiatric interview (mini). * onset of symptoms meeting the dsm-5 criteria for ptsd symptoms for a minimum of 6 months prior to screening. exclusion criteria: * the index traumatic event that led to the develop of ptsd took place \> 9 years before screening. * the index traumatic event occurred before age 16. * participants who have experienced a traumatic event within 3 months of screening. * participants who are receiving disability payments because of ptsd or any other psychiatric disorder; unless the disability payments will not be impacted by potential improvements demonstrated in the trial.

Keywords: ptsd
oropharyngeal administration of colostrum for preventing necrotizing enterocolitis in preterrms

Conditions: Prematurity

Summary: mother's milk samples will be collected during the routine expression of milk, using a hospital-grade electric breast pump, and will be stored in the nicu breastmilk refrigerator. the research doctor will prepare the syringes for the first 24 hours of the initial treatment period. for neonates in the placebo group, the milk is immediately frozen, in a separate nicu breastmilk freezer to maintain blinding, for later use when enteral feedings are started. using sterile gloves, oral syringes will be each filled with 1 ml/kg of colostrum or normal saline 0.9% (based on group assignment), capped, and covered with a white tape as a blinding procedure. each syringe will be labeled with the patient's name, medical record number, and the date and time of preparation. syringes will be prepared in the same sterile manner, by the research doctor, every 24 hours.

oropharyngeal administration procedure using a standardized protocol, the doctor will provide the dosing as follows: two syringes will be warmed to room temperature. the first syringe's cap is removed and the tip of the syringe is gently placed into the neonate's mouth, alongside the right buccal mucosal tissue. the syringe tip is directed posteriorly towards the oropharynx, and the total volume (0.5 ml/kg) is slowly administered, over 20 seconds. the second syringe will be placed in the neonate's mouth in the same manner, but alongside the left buccal mucosal tissue. the entire volume (0.5 ml/kg) is administered slowly, over 20 seconds. a petite swab is used to carefully swab the right buccal mucosal tissue, followed by the left buccal mucosal tissue (≤5 seconds each side). a total volume of 1 ml/kg is administered per treatment, with buccal swabbing taking place over 10 seconds. vital signs are carefully monitored throughout the procedure. dosing is provided every 3 hours during the period of study. sample size will be 34 in each group, . * group a: receiving oropharyngeal colostrum for 10 days. * group b: control group receiving placebo for 10 days. * group c: receiving oropharyngeal colostrum for 3 days.

Eligibility criteria:
inclusion criteria: * neonates with gestational age (ga) ≤ 34 weeks at birth * neonates who will be in admitted in the neonatal intensive care unit (nicu) within 48 hours after birth. exclusion criteria: * any contraindication for breastfeeding as mother-related (e.g. mothers prohibited from breastfeeding because of conditions including active tuberculosis or aids, treatment with radioisotopes (e.g., iodine-131, cobalt-60, cesium-137) and substance abuse) * also any contraindication for breastfeeding as infant-related (birth complicated with severe gastrointestinal malformations).
study of nilotinib in metastatic melanoma with kit aberrations

Conditions: Metastatic Melanoma With KIT Aberration

Summary: major response was observed to imatinib mesylate in kit-mutated metastatic rectal melanoma (hodi fs et al, j clin oncol 26:2046-2051, 2008). in the asco annual meeting in 2009ar, kit mutations were reported to be present in 23% of acral and 15.2% of mucosal melanomas (heinrich mc et al, j clin oncol 26:2008 abstr 9016). nilotinib is a novel tyrosine kinase inhibitor (tki) targeting kit, pdgfr, and bcr-abl and inhibiting the proliferating of both imatinib-sensitive and imatinib-resistant cells in vitro. phase i study of nilotinib alone and in combination with imatinib in patients with imatinib-resistant gastrointestinal stromal tumors (gist) demonstrated significant activity (72% stable disease for nilotinib alone and 56% for nilotinib/imatinib combination) (blay jy et al, j clin oncol 26:2008, abstr 10553). thus, we propose to conduct a phase ii study of nilotinib in metastatic melanoma with kit mutations.


Eligibility criteria:
inclusion criteria: 1. histologically or cytologically proven melanoma with stage iv or unresectable stage iii disease 2. documented kit aberration 3. adequate organ function as defined by the following criteria: * serum aspartate transaminase (ast); serum glutamic oxaloacetic transaminase (sgot)) and serum alanine transaminase (alt); serum glutamic pyruvic transaminase (sgpt)) ≤ 2.5 x local laboratory upper limit of normal (uln), or ast and alt less than or equal to 5 x uln if liver function abnormalities are due to underlying malignancy * total serum bilirubin ≤ 1.5 x uln * absolute neutrophil count (anc) ≥ 1500/µl * platelets ≥ 100,000/µl * hemoglobin ≥ 9.0 g/dl (may be transfused or erythropoietin treated) * serum calcium ≤ 12.0 mg/dl * serum creatinine ≤ 1.5 x uln 4. patients with cns metastasis must have stable neurologic function without evidence of cns progression within 8 weeks 5. may have previous adjuvant therapy with interferon, vaccines or therapy with il-2, chemotherapy 6. at least one measurable lesion by recist criteria 7. ecog ps 0-2 exclusion criteria: 1. major surgery or radiation therapy within 4 weeks of starting the study treatment. 2. history of or known carcinomatous meningitis, or evidence of symptomatic leptomeningeal disease on screening ct or mri scan. 3. ongoing cardiac dysrhythmias of nci ctcae grade ≥ 2. 4. qtc \> 470 msec on baseline ekg. 5. pregnancy or breastfeeding.
influence of the consumption of conventional and electric cigarettes on skin circulation

Conditions: Nicotine Dependence; Vaping; Smoking

Summary: the survey participants are divided into a smoking and non-smoking group. the smoker group is further divided according to the quantity and quality of nicotine ("normal" smoking, vaping). after reaching a steady state, the cutaneous blood flow at rest in the extremities of all participants is determined by laser doppler imaging as a reference value. laser doppler imaging produces images of the blood flow using perfusion units (pu). subsequently, the perfusion is measured again after smoking/vaping. the difference in skin perfusion of the extremities is calculated (δ-perfusion). all measurements are performed under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the patients.

after consenting to the study, the subjects are examined using laser doppler camera. the skin blood flow of the extremities is determined as a reference value. laser doppler imaging produces images of the blood flow using the perfusion units (pu). all measurements are taken under controlled vital parameters (body temperature, systolic and diastolic blood pressure, heart rate) and controlled room temperature as well as 15-minute acclimatization of the subjects. for smokers or vapers, the perfusion is measured again after consuming a cigarette or an e-cigarette respectively. the difference of blood flow after smoking or vaping is calculated using both measures. the total duration of the study per subject is approximately 25-30 minutes.

Eligibility criteria:
inclusion criteria: healthy adult non-smokers, smokers, vapers exclusion criteria: * adults with cardiopulmonary diseases * pregnant women * adults that participating in other surveys

Keywords: perfusion laser speckle contrast analysis laser doppler camera nicotine smoking vaping
evaluation of a novel head-mounted device for glaucoma testing: a proof-of-concept study

Conditions: Glaucoma

Summary: this proof-of-concept study aims to determine the feasibility and effectiveness of using a custom head-mounted device for visual field testing. the novel head-mounted device, with custom software, will be compared to a conventional visual field test: the humphrey visual field analyzer. the investigators will include 30 healthy normal patients, 30 glaucoma suspects, 30 patients with moderate glaucoma, and 30 patients with advanced glaucoma (total: 120 patients). each patient will perform the conventional test and the head-mounted device visual field test during the study visit, with the order (i.e., which device the patient starts with) being randomized. after the two tests, the patient will fill out a questionnaire to gather information regarding patient comfort and satisfaction. this will repeat each week for 5 weeks, for a total of 5 study visits. the results of the tests (sensitivity thresholds) will be compared. the investigators hypothesize that the results of the conventional and head-mounted device will be similar.


Eligibility criteria:
inclusion criteria: * previous visual field test with humphrey field analyzer indicating normal field, early glaucomatous field damage, moderate glaucomatous field damage, or advanced glaucomatous field damage. * ability to understand and consent to the study. exclusion criteria: * diagnosis of secondary glaucoma * diagnosis of non-glaucomatous optic neuropathy or other significant ophthalmic diagnosis that could limit vision (ex. age-related macular degeneration) * significant media opacity * previous intraocular surgery other than cataract surgery * anxiety disorder * pregnancy * seizure disorder * cardiac pacemaker or other implantable devices * severe vertigo or balance disturbance * refractive error greater than +4 diopters and less than -6 diopters spherical equivalent * inability to demonstrate competence to make informed decision regarding study participation
body temperature and perioperative bleeding in adolescent idiopathic scoliosis surgery

Conditions: Hypothermia; Anesthesia

Summary: in this study, patient groups in which normothermia is preserved by using multiple active warming methods in the intraoperative period in ais surgery, followed by a single compressed air blowing system and allowed mild to moderate hypothermia were compared.


Eligibility criteria:
inclusion criteria: * patients between the ages of 12-18 who were evaluated as asi by axial skeletal deformity, who would undergo elective deformity correction surgery, who did not have scoliosis due to a secondary cause, and whose data were allowed to be used by themselves and parents exclusion criteria: * patients with body weight \ 40kg / m2), known allergy, known bleeding-coagulation disease, use of drugs that affect blood clotting parameters in the last week, presence of hepatic, renal, hematological, rheumatological disease, the patient's own or family with psychiatric disorders who could not cooperate
non-invasive imaging of muscle structure in duchenne muscular dystrophy using multispectral optoacoustic tomography

Conditions: Duchenne Muscular Dystrophy; Muscular Dystrophies; Muscular Dystrophy, Duchenne

Summary: this pilot study aims to assess subcellular muscle structure in patients with duchenne x-linked progressive duchenne muscular dystrophy (dmd) in comparison to healthy volunteers using multispectral optoacoustic tomography (msot). during msot, a transducer is placed on the skin similar to a conventional sonography and instead of sound, energy is supplied to the tissue by means of light flashes. this leads to a constant change of minimal expansions and contractions (thermoelastic expansion) of individual tissue constituents or molecules. the resulting sound waves can then be detected by the same examination unit.

duchenne x-linked progressive duchenne muscular dystrophy (dmd) is one of the most common progressive childhood muscle diseases with an incidence of 1 in 3500 male newborns and is associated primarily with decreased life expectancy. from the age of 4-5 years manifest motor problems in everyday life, typical signs of proximal muscle weakness, with lab-chemical increase of the muscle enzyme (creatinine kinase, ck). within a few years, relevant muscle and tendon shortening leading to joint malpositions and instability, as well as scoliosis and loss of walking around the age of 10 are formed. supportive therapies can not curatively affect complications and progression of the disease. pathogenetically, there is a deficiency of dystrophin, a structural protein of the sarcolemma, which is caused by mutations (usually deletions) of the dystrophin gene (xp21.3-p21.2). the result of dystrophin deficiency is a necrosis of muscle cells that are replaced by connective tissue and adipose tissue. clinical scores (6-minute walk test, 6mwt) and mri studies to characterize the degenerative changes of skeletal muscle in the early stages are available for the quantitative assessment of the disease progression as well as therapy effects, the significance of which is controversially discussed. however, the highly sensitive assessment of gene therapy effects (e.g., ptc 124) will become increasingly important in the future. sensitive, non-invasive methods for the detection of early muscle degeneration and muscle function in the course are of great clinical and scientific importance. the purpose of this first pilot study is to investigate whether the differences in skeletal muscle composition of healthy volunteers and ambulatory patients with early stage dmd can be quantified and characterized using multispectral optoacoustic tomography (msot). this could in the future generate a completely new, non-invasive method to develop non-invasive biomarkers of disease progression or therapy response.

Eligibility criteria:
dmd-patients inclusion criteria: * histologic or genetically proven dmd * age 3-10 years exclusion criteria: - healthy controls inclusion criteria: * male * age 3-10 years exclusion criteria: * suspected muscular disease/myopathia * missing informed consent

Keywords: optoacoustics msot multispectral optoacoustic tomography
one or two week methotrexate discontinuation on efficacy of influenza vaccination in rheumatoid arthritis.

Conditions: Rheumatoid Arthritis; Autoimmune Diseases; Influenza; Vaccine Reaction

Summary: this is a multi-center, randomized, single-blinded, prospective, parallel group intervention study to investigate whether methotrexate (mtx) discontinuation for 1 week is non-inferior to mtx discontinuation for 2 weeks in regard to satisfactory vaccination response to a seasonal influenza.


Eligibility criteria:
inclusion criteria: * males or females ≥ 19 years of age at time of consent * have a diagnosis of ra per acr criteria * must understand and voluntarily sign an informed consent form including writing consent for data protection * stable doses of methotrexate over the preceding 6 weeks exclusion criteria: * pregnant or lactating females * previous anaphylactic response to vaccine components or to egg. * acute infection with t \>38°c at the time of vaccination * history of guillain-barre syndrome or demyelinating syndromes * blood transfusion within 6 months * any other rheumatic disease such as systemic lupus erythematosus, mixed connective tissue disease, dermatomyositis/polymyositis, and vasculitis except for secondary sjogren's disease * any condition including laboratory abnormality which places the subject at unacceptable risk * subjects who decline to participate

Keywords: rheumatoid arthritis methotrexate influenza
safety and immunogenicity of an inactivated vaccine against covid-19 in medical workers

Conditions: SARS-CoV-2 Infection; Covid19

Summary: with the unprecedented morbidity of the covid-19 pandemic, the vaccine effectiveness needs to be assessed across diverse populations. the purpose of this study is to evaluate the safety and immunogenicity of an inactivated sars-cov-2 vaccine in medical workers.

1370 participants who were negative for serum-specific antibodies against sars-cov-2 at the time of screening were enrolled and were receive a two-dose schedule, 21 days apart, with 4 μg bbibp-corv inactivated sars-cov-2 vaccine. the primary safety outcome includes solicited local and systemic reactions prompted by and recorded in an electronic diary within 7 days post each injection, unsolicited adverse events and serious adverse events assessed from the receipt of each dose, and clinical laboratory abnormalities from dose 1 through 1month after dose 2. laboratory tests included measurement of alanine aminotransferase, aspartate aminotransferase, serum total bilirubin, serum albumin, creatinine, blood urea nitrogen, and blood routine examination. immunogenicity was assessed as the serum anti-sars-cov-2 specific antibody responses and neutralizing activity at 4 weeks after the second vaccination.

Eligibility criteria:
inclusion criteria: * written informed consent according to ich/gcp regulations prior to any trial specific procedures. * male or female aged 18-59 years. exclusion criteria: * na

Keywords: sars-cov-2 covid19 inactivated vaccine
99mtc-h7nd spect/ct imaging in nsclc

Conditions: NSCLC

Summary: to study the clinical application of 99mtc-h7nd spect/ct imaging in the efficacy evaluation and prediction of non-small cell lung cancer (nsclc)

this study was a prospective, controlled, single-center clinical study. to evaluate the value of 99mtc-h7nd imaging in the evaluation of stable disease in patients with non-small cell lung cancer (nsclc) assessed by recist1.1, and to predict the efficacy of subsequent treatment (second-line treatment). patients with nsclc confirmed by cytology or pathology, who were unable to undergo radical surgery because of recurrence, metastasis, or their own conditions, and who had completed 2-4 cycles of first-line therapy and had recist1.1 assessment (sd) were divided into 2 groups: experimental group: 99mtc-h7nd spect/ct imaging performed control group: 99mtc-h7nd spect/ct imaging was not performed

Eligibility criteria:
inclusion criteria: 1. patients aged from 18 to 80 years old; 2. patients with nsclc confirmed by needle aspiration cytology or surgical pathology, who cannot undergo radical surgery due to recurrence, metastasis or patient's own conditions; 3. has completed 2-4 cycles of first-line therapy (including chemotherapy, immunotherapy, chemotherapy combined with immunotherapy, chemotherapy combined with targeted therapy, etc.), and has sd assessed by recist 1.1 during the same period; 4. patients had at least one measurable lesion; 5. no local radiotherapy for primary or metastatic lesions within 28 days; 6. ecog score 0-2; 7. expected survival time ≥3 months; 8. voluntarily participate and sign informed consent. exclusion criteria: 1. women who plan to become pregnant within 6 months, or are pregnant or lactating. 2. patients with severe brain or bone metastases; 3. severe anemia and severe liver and kidney damage; 4. pathological or long-term follow-up results may not be available; 5. the relevant control imaging data and clinical data were not available; 6. severe illness is difficult to cooperate (such as acute cardiovascular and cerebrovascular events or serious cardiovascular diseases); 7. received any surgery or invasive treatment or procedure within 4 weeks before enrollment; 8. cannot tolerate standard second-line therapy or other first-line therapies. 9. known allergy to 99mtc-h7nd or any of its components; he had a history of severe allergies; 10. protocol imaging contraindications were present; 11. the investigator considered it inappropriate to participate in the study.

Keywords: 99mtc-h7nd spect/ct nsclc diagnostic efficiency therapeutic effect evaluation
superior trunk block applied for upper arm surgery

Conditions: Post Operative Pain

Summary: nerve blocks applied with ultrasonography are currently used for many post-operative pain and operations. providing adequate area analgesia is the primary goal of clinicians, as early mobilization is suggested after shoulder and arm surgery. in this study aimed to investigate the effect of superior trunk block application on postoperative analgesic and motor functions.


Eligibility criteria:
inclusion criteria: * patients who were in the american society of anesthesiologists (asa) i-iii class * underwent upper arm surgery exclusion criteria: * previous local anesthetic allergy, * having a bleeding diathesis disorder, * mental disorder, * allergic to the drugs used, * patients who did not consent to participate in the study, * presence of infection in the block area, * patients with a body mass index above 30
l-prf versus a-prf on palatal wound healing

Conditions: Palate; Wound

Summary: different approaches are used to reduce post-operative complications associated with the palatal wound site after free gingival graft (fgg) harvesting. the aim of this study was to compare the effects of l-prf and a-prf on palatal wound healing after free gingival graft harvesting and patients' quality of life.

thirty-six patients between the ages of 18 and 60 years (11 males and 25 females) who had completed phase 1 periodontal treatments and for whom fgg surgery was indicated for isolated gingival recession defects limited to one or two teeth with shallow vestibule and insufficient keratinized or attached gingival width were included in the present study. three different treatments were performed on palatal wound areas: l-prf (l-prf group, n = 12), a-prf (a-prf group, n = 12) and palatal stent (control group, n = 12) ohip-14 scores, vas scores (for pain), analgesic tablet intake, and epithelialization condition were recorded for different time points.

Eligibility criteria:
inclusion criteria: • patients ≥18 years requiring fgg surgery because of shallow vestibule and insufficient keratinized/attached gingival width exclusion criteria: * no smoking /no alcohol use, * not suffering from any systemic disease that could impair the healing of wounds, * pregnancy or lactation, * previous graft harvesting from the same site.

Keywords: free gingival graft platelet rich fibrin