Kornimate/medical-research-clean huggingface dataset:
study of application of transcutaneous trigeminal nerve stimulation on autism spectrum disorder

Conditions: Autism Spectrum Disorder

Summary: this study aims to evaluate the safety and the efficacy of applying transcutaneous trigeminal nerve stimulator (nueyne p01) on autism spectrum disorder.

duration of study period (per participant): screening period (-28\~0 days), intervention period (28 days) patient needs to visit site at least 4 times (v1, v2, v4, v6). v2 can be done with v1. tele-visit should be done on v3 (day 7), v5 (day 21).

Eligibility criteria:
inclusion criteria: * children over 7 years old and under 12 years old * patients diagnosed with autism spectrum disorder * a person who has a total intelligence index of 70 or higher and has no problems with basic language communication * a person who agrees not to use any medical device other than this clinical trial medical device during the clinical trial period * a person who does not take a concurrent drug from screening to the end of the study, or who can maintain the concurrent drug during the clinical trial period without any change or addition * voluntary written consent to participate in this clinical trial exclusion criteria: * those who participated in other clinical trials within 30 days from the screening date * if it is difficult to understand the contents of treatment due to the limitation of intelligence index or language ability, and if it is difficult to conduct a study * when there is a risk of clinically significant behavioral problems, emotional control problems, psychiatric symptoms, self-harm, or other harm that can affect the treatment process * psychiatric hospitalization history * a person with acute or chronic medical or mental illness * a person with a history of seizures * serious trauma and surgery within 1 month * a person who is deemed to have a problem with the adhesion of electrodes due to inflammatory reactions or other dermatological problems on the skin around the forehead to which electrodes of clinical trial medical devices are attached * if it is need to take sleep medications \[benzodiazepine, melatonin, trazodone\] (\*however, it is participated after having a washout period of at least two weeks.) * a person who is deemed to have other reasons for prohibition of use of clinical trial medical devices (including heart-related problems, seizures, metal or electronic devices implanted in the head, people with unknown pain, pacemaker transplant, etc.) * when it is determined by the researcher that it is difficult for the subject to continue voluntary participation in the study due to the lack of cooperation and motivation for treatment * other cases where it is deemed difficult to participate in the study by the researcher's judgment

Keywords: asd
cxcl9, cxcl10, cxcl11, and cxcr3 in dry eye syndrome

Conditions: Dry Eye Syndrome

Summary: the aim of this study is to investigate the expression of cxcl9, cxcl10, cxcl11, and cxcr3 in the tear film and ocular surface of patients with dry eye syndrome. thirty-three patients with dry eye (16 sjögren's syndrome and 17 non-sjögren's syndrome patients) and 15 control subjects were recruited. the concentrations of cxcl9, cxcl10, and cxcl11 in tears were measured using enzyme-linked immunosorbent assay. the correlation between chemokine levels and tear film and ocular surface parameters was analyzed. expression of cxcl9, cxcl10, cxcl11, and cxcr3 in the conjunctiva was evaluated using immunohistochemistry. flow cytometry was performed to count cxcr3+ cells and cxcr3+cd4+ cells in the conjunctiva.


Eligibility criteria:
inclusion criteria: * clinical diagnosis of dry eye syndrome exclusion criteria: * active ocular infection or inflammation not associated with dry eye * drug toxicity * contact lens wear * ocular allergy * ocular surgery within the last 3 months * lid or lash abnormalities

Keywords: dry eye syndrome cxcl9 chemokine cxcl10 chemokine cxcl11 chemokine cxcr3 receptor
effect of interscalene block methods on rebound pain

Conditions: Anesthesia; Pain, Shoulder; Pain, Postoperative

Summary: in this study, the hypothesis that local anesthesia, not directly injected into the nerve root, may reduce the incidence of rebound pain in the interscalene block with an extraplexus approach during arthroscopic shoulder surgeries will be investigated. rebound pain is defined as a short-term but severe pain before and after the resolution of the interscalene block and will be evaluated using the numerical rating scale (nrs) (nrs ≥ 7).

the study will include patients aged 18-65 years, with an american society of anesthesiologists (asa) physical status of i or ii, scheduled for arthroscopic shoulder surgery in the lateral decubitus position, accompanied by interscalene nerve block performed by the same surgeon. patient characteristics (age, gender, body mass index, etc.), block procedure duration, number of needle passes, onset time of sensory block, onset time of motor block, and possible complications related to the block (paresthesia, horner's syndrome, dyspnea, hoarseness), postoperative nausea and vomiting (ponv) status, and quality of recovery-15 (qor-15) scores on the preoperative first day and postoperative days 1 and 7 will be recorded. the primary outcome parameter will be the incidence of rebound pain. rebound pain will be defined as a short-term but severe pain before and after the resolution of the interscalene block, assessed using the numerical rating scale (nrs) (nrs ≥ 7). secondary outcomes will include the number of needle passes, block application time, onset time of sensory block, onset time of motor block, intraoperative dexmedetomidine requirement, duration of block effectiveness, postoperative pain, ponv, need for rescue analgesics, incidence of paresthesia and horner's syndrome, dyspnea, hoarseness, duration of stay in the recovery room, duration of rebound pain, and postoperative quality of recovery-15 (qor-15) scores.

Eligibility criteria:
inclusion criteria: * patients aged 18-65 years. * patients with asa physical status i or ii. * patients planned for arthroscopic shoulder surgery in the lateral decubitus position with interscalene nerve block. exclusion criteria: * patients who do not consent to participate in the study. * block failure. * language acquisition deficiency. * obesity (body mass index \> 35 kg/m²). * diabetes. * psychiatric disorders. * central nervous system diseases. * vestibular diseases. * presence of neuropathy and paralysis. * pregnancy. * previous open shoulder surgery. * allergy to local anesthetics. * coagulopathy. * severe thrombocytopenia. * infection at the puncture site. * pre-existing neuropathy in the limb to be operated. * use of dexamethasone. * use of opioid and antiemetic medications before surgery. * severe cardiopulmonary disease. * low baseline oxygen saturation. * conditions that prevent cooperation in the postoperative period (e.g., mental retardation, delirium).

Keywords: anesthesia interscalene block rebound pain
lipofilling as a treatment for vestibulodynia

Conditions: Vestibulodynia

Summary: the investigators would like to investigate if lipofilling with its adipose derived stem cells (adsc) could be a new, less invasive but equally or more effective therapeutic option for women with vestibulodynia than vestibulectomy. the investigators expect the study to be successful because of the anti-inflammatory effects of the adsc and its effectiveness -although not thoroughly studied- in some neuropathic pain disorder like pudendal neuralgia or post mastectomy pain syndrome. method: a controlled intervention study: one group receiving golden standard therapy 'vestibulectomy' and one group receiving vestibular lipofilling.


Eligibility criteria:
inclusion criteria: * vestibulodynia requesting surgery exclusion criteria: -
early administration of tranexamic acid and acute blood loss in patients with hip fractures

Conditions: Hip Fractures; Blood Loss

Summary: the study is a prospective, randomized, double blinded, placebo controlled trial that aims to investigate the hypothesis that early administration of tranexamic acid (txa) following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. patients who present to the hospital with a hip fracture will be recruited and randomized into two treatment arms. the treatment group will receive 1950mg of oral txa (three tablets, 650 mg each) and the control group will be given three tablets of oral placebo while in the emergency department. patients will then be admitted to the orthopaedic trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.

there remains a high incidence of blood transfusion in patients following hip fractures. tranexamic acid (txa) has well-studied efficacy in decreasing blood loss and transfusion requirements in the context of general trauma, as well as several elective orthopaedic procedures. although blood is lost in hip fracture surgery itself, it is also known that there is significant blood loss pre-operatively following the hip fracture event, particularly in extracapsular hip fractures. a prospective, randomized, double blinded, placebo controlled trial will elucidate the roll of early administration of txa in a population of patients who sustain hip fractures. the study aims to investigate the hypothesis that early administration of txa following diagnosis of hip fracture will lower pre and postoperative blood loss and transfusion rates. there will be two treatment arms in the study. the treatment group will be given 1950mg of oral txa (3 tablets, 650mg each) in the emergency department following diagnosis of hip fracture. those randomized to the control group will be given 3 tablets of oral placebo in the emergency department following diagnosis of hip fracture. patients will then be admitted to the orthopaedic trauma service and treated surgically with cephalomedullary nail, hemiarthroplasty, sliding hip screw, percutaneous screws, or total hip arthroplasty.

Eligibility criteria:
inclusion criteria: * age over 50 * clinical diagnosis of acute femoral neck, intertrochanteric or subtrochanteric femur fracture exclusion criteria: * anticoagulant use at time of admission to emergency department * documented allergy to tranexamic acid * history of deep vein thrombosis or pulmonary embolism * hepatic dysfunction (aspartate aminotransferase (ast)/alanine aminotransferase (alt) \> 60) * renal dysfunction (creatinine \> 1.5 or glomerular filtration rate \< 30) * active coronary artery disease (event within 12 months) * history of cerebral vascular accident within 12 months * presence of drug eluting stent * color blindness * active cancer * coagulopathy (international normalized ratio \> 1.4, partial thromboplastin time \> 1.4 times normal, platelets \< 50,000)

Keywords: hip fracture blood loss tranexamic acid
choroidal thickness change in response to physiological and refractive changes

Conditions: Refractive Errors; Accommodation Disorder

Summary: there is a great need for precise and repeatable measurements of the choroidal thickness. including the diurnal physiological changes, accommodation and refractive error impact on those measurements.


Eligibility criteria:
inclusion criteria: * participants with refractive error * willing and able to understand and sign an informed consent form exclusion criteria: * patient unable to participate in the study * any disease that causes visual opacity of optic media that unable to perform oct scanning * current enrolment in another clinical trial/research project
assessment of gsk biologicals' tdap candidate vaccine administered as a booster (6th dose) in terms of immunogenicity and safety to children and adolescents previously vaccinated with five doses of an acellular pertussis-containing vaccine.

Conditions: Acellular Pertussis; Diphtheria; Tetanus

Summary: the aims of this study are to evaluate the safety and immunogenicity of a booster dose of gsk biological's candidate tdap vaccine containing 0.3 mg al when administered to healthy school children and adolescents (9-13 years of age) previously vaccinated with five consecutive doses of pa-containing vaccine. the inclusion of hepatitis a vaccine (havrix®) as a control vaccine enables this study to be conducted in a double-blinded in terms of immunogenicity and safety assessments.


Eligibility criteria:
inclusion criteria: - subjects previously enrolled and vaccinated in gsk biologicals' studies apv-118 and apv-120 and who were 9 through 13 years of age exclusion criteria: * use of any investigational or non-registered drug or vaccine other than the study vaccines within 30 days preceding the administration of study vaccines, or planned use during the study period. * chronic administration or planned administration of immunosuppressants or other immune modifying drugs within six months prior to study vaccination or planned administration during the study period * administration of immunoglobulins and/or blood products within 3 months prior to vaccination
convalescent plasma for treatment of covid-19

Conditions: Covid19

Summary: convalescent plasma has been shown to be safe and effective for treatment of several diseases. preliminary data indicate that it is safe for treatment of covid-19. we found that viremia upon admission identifies patients at 7 fold increased risk of admission to intensive care and 8 fold increased risk of death. cp treatment appeared to result in rapid viral clearance in a small case series. cp appeared to be well tolerated in a phase i study in which patients only received one dose of cp and a phase ii study in which cp was given until viremia disappeared (unpublished data). randomised controlled studies assessing the efficacy of cp are lacking and thus the efficacy of cp is unknown. preliminary data indicate that treatment should be given early, prior to development of severe illness. detection of viremia upon admission identifies a group at high risk of severe disease and death that has the most to benefit from cp. phase ii study data indicates that treatment should be given until sars-cov-2 is no longer detected in serum and the donor antibody neutralization titres should be ≥1/640. a randomised controlled trial in which viremic patients are treated with cp with the equivalent of an antibody titre ≥1/640 is thus required to determine if cp can be an effective covid-19 treatment.


Eligibility criteria:
inclusion criteria: * age greater than or equal to 18 * admitted to a study hospital * active covid-19 defined as symptoms + sars cov-2 identified from upper or lower airway samples and blood * negative pregnancy test taken before inclusion and use of an acceptable effective method of contraception until treatment discontinuation if the participant is a woman of childbearing potential * written informed consent after meeting with a study physician and ability and willingness to complete follow up exclusion criteria: * no matching plasma donor (exact matching in the abo system is required) * unavailability of plasma * estimated glomerular filtration rate \<30 (kidney failure stage iii or more) * pregnancy (urinary-hcg) * breast feeding * inability to give informed consent

Keywords: covid-19 convalescent plasma treatment sars-cov-2 infection viremia
effectiveness of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic for uti prevention

Conditions: Urological System Complication of Procedure; Urinary Tract Infections

Summary: the goal of this clinical trial is to compare the use of single dose fosfomycin and single dose levofloxacin as pre-urodynamic antibiotic prophylaxis for urinary tract infection prevention post-urodynamic in patients with lower urinary tract symptoms. the main question\[s\] it aims to answer are: * what is the difference between the effectiveness of administering a single dose of fosfomycin and levofloxacin prior to the procedure in terms of the incidence rate of urinary tract infection (uti) post-urodynamic examination? * what is the incidence rate of uti in the administration of single-dose fosfomycin and levofloxacin prior to the procedure on the incidence rate of uti post-urodynamic examination? participants fulfilling the inclusion criteria will be taken their history and vital signs and consume either fosfomycin or levofloxacin based on the randomisation prior to urodynamic procedure. afterwards, participants will undergo urine analysis 4 days post urodynamic to evaluate if there's any urinary tract infection. if there is any bacteria present, the sample will be cultured to identify bacteria found in the urine.

this study employs a single-blinded randomized clinical trial design to compare the proportion of uti post-urodynamic examination between the group receiving single-dose levofloxacin pre-urodynamic examination and the group receiving levofloxacin post-urodynamic examination for three days. the target population consists of patients undergoing urodynamic examination at dr. cipto mangunkusumo national referral hospital, persahabatan national hospital, and siloam asri hospital. the total sample size required for this study is 126 patients. on the fourth day post-urodynamic examination, urinalysis and urine culture are performed to determine the diagnosis of uti. to analyze the association between uti and therapy groups, a chi-square test is used. results are considered statistically significant if p \< 0.05.

Eligibility criteria:
inclusion criteria: * male/female patients \> 18 years who have indications for urodynamics * willing to participate in research exclusion criteria: * allergy to levofloxacin * allergy to fosfomycin * history of taking antibiotics in 1 month * pregnant * uncontrolled dm * use of urinary catheter * having a uti before urodynamics, based on clinical symptoms and urine examination results * refuse to participate in research

Keywords: urodynamic urinary tract infections fosfomycin levofloxacin
radiofrequency diathermy and therapeutic exercise protocol in women with abdominal diastasis

Conditions: Abdominal Diastasis

Summary: diastasis recti abdominis (dra) is defined as the presence of divergence between the rectus abdominis muscles along the linea alba. dra is associated with decreased abdominal strength and degraded health and physical functioning, which results in poorer body perception and satisfaction and negatively affects the quality of life in its multiple spheres (social, sexual and personal). regarding the different treatment techniques for dra, different treatments have been described, such as bandages, electrotherapy or therapeutic exercise, the latter being the most scientifically supported option to approach dra conservatively. exercise has shown positive effects on dra severity, abdominal muscle thickness, abdominal strength and endurance, and quality of life in women with dra. another treatment that has shown promising effects in various pathologies is radiofrequency diathermy using the capacitive-resistive electrical transfer system. the capacitive mode acts on soft tissues containing electrolytes such as muscles and vascular and lymphatic tissues. on the other hand, the resistive mode acts on tissues of higher density and fat and fiber content, such as bones, ligaments and tendons. it has been documented that this type of therapy acts favoring the vascularization of tissues, decreasing inflammation and favoring the processes of cellular repair and analgesia. its beneficial effect on low back pain and various pelvic floor disorders has been studied. however, at present, there are no studies evaluating the effectiveness of this type of intervention in people with abdominal diastasis. in view of the above, the objective of our study is to evaluate the effectiveness of a protocol based on therapeutic exercise preceded by a radiofrequency diathermy program on anthropometric parameters, anatomo-physiological parameters, functional parameters, and parameters related to psychological aspects in women with postpartum abdominal diastasis.

a longitudinal randomized controlled experimental study will be carried out. the sample will be composed of 34 postpartum women, randomly distributed in two groups: i) diathermy + exercise group (gde) (n=17), and ii) placebo diathermy + exercise group (gpe) (n=17). the evaluations will be performed at two time points: i) before the intervention (t1), and ii) after the last session (t2).

Eligibility criteria:
inclusion criteria: * women aged 18 to 45 years, * 3 to 24 months postpartum * criteria of abdominal diastasis according to beer's criteria (beer et al.2009) exclusion criteria: * rejection to sign the informed consent form * presence of any metabolic, neurological or connective tissue disease, as well as cognitive alterations.
osimertinib combined with bevacizumab in the treatment epidermal growth factor receptor (egfr) exon 20 insertions metastatic non-small cell lung cancer

Conditions: Carcinoma, Non-Small-Cell Lung

Summary: there is no muture method to treat egfr 20 insertion mutation non-small-cell lung cancer (nsclc). the he purpose of this study is to study osimertinib combined with bevacizumab in the management of it.

lung cancer is one of the most common types of cancer and is the most common cause of death from cancer (almost 20 percent \[%\] of cancer deaths); nsclc accounts for 80% to 85% of lung cancers. the hypothesis is that osimertinib combined bevacizumab in patients with locally advanced or metastatic nsclc characterized by egfr exon 20ins activating mutations. efficacy assessments will include disease assessment, symptomatic progression and patient-reported outcome. safety assessments will include physical examinations, vital signs, electrocardiograms (ecgs), eastern cooperative oncology group (ecog) performance status and clinical safety laboratory assessments (serum chemistry, hematology, coagulation, and urinalysis).

Eligibility criteria:
inclusion criteria: participant must have histologically or cytologically confirmed, locally advanced or metastatic, nonsquamous non-small cell lung cancer (nsclc) with documented primary epidermal growth factor receptor (egfr) exon 20ins activating mutation participant must have measurable disease according to response evaluation criteria in solid tumors (recist) v1.1. participant must have eastern cooperative oncology group (ecog) performance status 0 or 1, or 2 participant must agree to genetic characterization of tumor status through the required pretreatment tumor biopsy (or submission of equivalent archival material), as well as baseline and periodic blood samples for analysis of tumor mutations in the bloodstream a female participant of childbearing potential must have a negative serum or urine test at screening and within 72 hours of the first dose of study treatment and must agree to further serum or urine pregnancy tests during the study exclusion criteria: participant has history of spinal cord compression that has not been treated definitively with surgery or radiation participant has a medical history of interstitial lung disease (ild), including drug-induced ild, or radiation pneumonitis participant has a contraindication to the use osimertinib or bevacizumab

Keywords: bronchial neoplasms egfr exon20ins mutation