Kornimate/medical-research-clean huggingface dataset:
evaluation of long-acting lenacapavir for the treatment of hiv-1 in treatment-experienced adolescents and children

Conditions: HIV-1-infection

Summary: the goal of this clinical study is to learn more about the study drug, lenacapavir (len). the study will assess the safety, tolerability, and efficacy of long-acting len when combined with other medicines in adolescents and children living with hiv-1 who weigh at least 35 kg and have been treated before for hiv-1. the study will also see how easy it is for participants to take len as injection or an oral pill. the primary objectives are to evaluate the pharmacokinetics and safety of len in combination with optimized background regimen (obr) in te pediatric participants with hiv-1.


Eligibility criteria:
key inclusion criteria: * body weight at screening ≥ 35 kg. * on a stable failing antiretroviral (arv) regimen for \> 8 weeks before screening and willing to continue the regimen until day 1. * plasma hiv-1 rna ≥ 400 copies/ml on at least 2 consecutive occasions spanning at least 6 months, including at screening. * have previously changed their arv regimen due to treatment failure. * arv treatment options limited due to resistance, tolerability, contraindications, safety, drug access. * able and willing to commit to taking len in combination with their obr. * the following laboratory parameters at screening: 1. estimated glomerular filtration rate (egfr) ≥ 60 ml/min/1.73 m\^2 using bedside schwartz formula. 2. absolute neutrophil count \> 0.50 gi/l (\> 500 cells/mm\^3). 3. hemoglobin ≥ 85 g/l (\> 8.5 g/dl). 4. platelets ≥ 50 gi/l (≥ 50,000/mm\^3). 5. hepatic transaminases (aspartate aminotransferase and alanine aminotransferase) ≤ 5 × upper limit of normal. 6. total bilirubin ≤ 23 μmol/l (≤ 1.5 mg/dl) and direct bilirubin ≤ 7 μmol/l (≤ 0.4 mg/dl). key exclusion criteria: * life expectancy ≤ 1 year. * an opportunistic illness requiring treatment within the 30 days prior to screening. * evidence of active pulmonary or extra-pulmonary tuberculosis within 3 months prior to screening. * hepatitis c virus (hcv) antibody positive with detectable hcv rna at screening. * hepatitis b virus (hbv) surface antigen (hbsag) positive or hbv core antibody (antibody against hepatitis b core antigen (anti-hbc)) positive; if individual is hbsag negative and anti-hbc positive but hbv dna undetectable, individual may be enrolled. note: other protocol defined inclusion/exclusion criteria may apply.
individualized automatic target coaching message for glycemic management and depressive symptom

Conditions: Diabetes Mellitus, Type 1

Summary: this is a single-center, randomized, prospective, feasibility and acceptability trial in patients with type 1 diabetes. for six weeks, the intervention group will receive weekly personalized coaching messages for glycemic management based on blood data from continuous glucose monitors and bi-weekly personalized coaching messages for depression management based on depression questionnaires. the control group will remain on their current treatment and will not receive any intervention. the purpose of this trial is to evaluate the feasibility and acceptability of the clinical application of automated, personalized coaching messages for glycemic management and depressive symptom in people with type 1 diabetes.


Eligibility criteria:
inclusion criteria: * patients who are determined to use continuous glucose monitoring based on their physician's medical judgment. * patients with type 1 diabetes, age 20-69 years old * currently receiving treatment with multiple insulin injection therapy * patients who have access to kakaotalk via smartphone and are able to communicate with it * voluntarily agreed to participate in this clinical study. exclusion criteria: * subjects using oral hypoglycemic agents * steroid and immunosuppressant users * subjects receiving anticancer medications * breastfeeding or pregnant patients * patients who do not voluntarily consent to the study * anyone deemed unsuitable by the investigator to participate in the study
second-line treatment with icotinib in esophageal carcinoma patients with egfr overexpression (ihc 3+) or positive fish

Conditions: Adenocarcinoma of the Gastroesophageal Junction; Esophageal Carcinoma

Summary: this study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with egfr overexpression (ihc 3+) or positive fish, the primary endpoint is objective response rates.

epidermal growth factor receptor (egfr) signaling is critical for cancer cell proliferation, invasion, metastasis, and resistance to apoptosis.egfr is overexpressed in many epithelial malignancies and therefore makes an attractive therapeutic target.this study is designed to evaluate the efficacy and safety of icotinib in treating advanced carcinoma of the gastroesophageal junction and esophagus with egfr overexpression (ihc 3+) or positive fish, the primary endpoint is objective response rates. secondary endpoints include progress-free survival, overall survival, safety and so on.

Eligibility criteria:
inclusion criteria: * patients with a histologic or cytologic diagnosis of carcinoma of the gastroesophageal junction or esophagus; * measurable disease by response evaluation criteria in solid tumors (recist) criteria; * overexpression of egfr defined by immunohistochemistry (3+) or gene amplification by fluorescence in-situ hybridisation; * have progressed after one chemotherapy regimen; * age 18-75 years old with performance status of 0 to 2 exclusion criteria: * prior targeted therapy with erlotinib, gefitinib, and so on * evidence of clinically active interstitial lung diseases (patients with chronic, stable, radiographic changes who are asymptomatic need not be excluded). * known severe hypersensitivity to icotinib or any of the excipients of this product. * evidence of any other significant clinical disorder or laboratory finding that makes it undesirable for the subject to participate in the study.
a trial of "apl-9796'' in adults with pulmonary hypertension

Conditions: Pulmonary Arterial Hypertension

Summary: the ap13cp02 study is a phase 2, open-label, dose escalation trial to determine how safe and tolerable multiple subcutaneous (sc) injections of apl-9796 are for patients with ph. the study will also assess how effective apl-9796 could be for treating patients with ph and whether the body produces antibodies working against apl-9796. the trial will be conducted in two parts: * part a: up to 36 adults with who group 1 pulmonary arterial hypertension (pah). * part b (optional): up to 12 adults with who group 3 - ph associated with ild (ph-ild).


Eligibility criteria:
inclusion criteria: 1. participant must be 18 to 80 years of age inclusive 2. participants who are diagnosed with pulmonary hypertension via right heart catheterisation (rhc), documented at any time prior to screening. 3. who functional class ii or iii 4. participant has the cardiomems pa sensor implanted. exclusion criteria: 1. hospital admission related to ph within 3 months prior to screening. 2. major surgical procedure within 3 months prior to screening, unless participant is assessed as completely recovered by the investigator 3. diagnosis of ph due to human immunodeficiency virus, portal hypertension, schistosomiasis, or uncorrected congenital heart disease 4. history of left-sided heart disease and/or clinically significant cardiac disease 5. history of uncontrolled systemic hypertension 6. egfr ≤30 ml/min/1.73m2 7. life expectancy of \< 12 months, as assessed by the investigator 8. diagnosed with a malignancy within 5 years of enrolment 9. contraindications to protocol-required imaging (mri), diagnostic, or sampling methods

Keywords: pulmonary hypertension who group 3 who group 1 ph
visual outcomes with a trifocal iol in subjects with open-angle glaucoma

Conditions: Cataract; IOL; Glaucoma, Open-Angle

Summary: this study will examine the visual outcomes of subjects undergoing cataract surgery and minimally invasive glaucoma surgery with the implantation of a trifocal intraocular lens.


Eligibility criteria:
inclusion criteria: 1. male or female subjects 45 years of age or older 2. a visually significant cataract 3. diagnosis of mild oag * vertical c/d ratio of less than or equal to 0.8 * vf characteristics consistent with glaucoma with mean deviation not worse than -6.00 db and without fixation threatening scotoma and/or with nerve abnormalities consistent with glaucoma (rim notching, rim thinning, disc hemorrhage, nerve fiber layer loss) * medicated iop 25 of less than or equal to mmhg on 1-3 medications * if treatment naïve (before glaucoma treatment) iop between 21 and 35 mmhg 4. glaucoma must be judged as stable by investigator based on review of subject medical records * stable vf at least 1 year prior to surgery * stable nerve fiber layer at least 1 year prior to surgery * iop stable on current medication regimen at least 3 months prior to surgery 5. shaffer grade of greater than iii in all quadrants 6. potential of good best corrected visual acuity at distance in the investigator's judgement of at least 0.1 logmar (20/25) postoperatively 7. able and willing to comply with follow up visits 8. understands and signs the informed consent exclusion criteria: 1. previous incisional glaucoma surgery or cilio-ablative surgery 2. prior laser trabeculoplasty within 90 days of surgery 3. pseudoexfoliative, angle closure, uveitic, congenital, traumatic, angle recession, or neovascular glaucoma. 4. moderate glaucoma with vf mean deviation between -6.00 db and -12.00 db 5. severe and/or progressive glaucoma defined as * vf mean deviation worse than -12.00 db * consistent worsening of visual field on review of subject medical records * consistent and progressive thinning of nerve fiber layer on review of subject medical records * uncontrolled iop on maximum glaucoma medications * historically poor iop control with medical therapy * severe focal notching of the optic nerve rim * expectation for future need of incisional glaucoma surgery 6. ocular pathology or other medical condition which, in the investigator's judgment places the subject at increased risk of complications or significant vision loss during study period. 7. ocular pathology that in the investigator's judgment may impact visual acuity postoperatively, i.e. significant ocular surface disease, corneal scarring, blepharitis, epiretinal membrane, macular degeneration, history of significant ocular trauma with sequela, etc. 8. pregnant or breastfeeding women 9. prior refractive surgery e.g. lasik, rk, prk, etc.

Keywords: panoptix trifocal iol glaucoma migs
incidence , risk factors and outcomes of haemodynamic instability and cardiac arrest during spine surgery

Conditions: Spine Surgery

Summary: risk factors for cardiac arrest during spine surgery have been well defined, including lumbar fusion, age over 65 years, obesity, cardiovascular disease, ethnicity and asa status. bradycardia and asystole have been described under general anaesthesia in combined surgical cohorts: proposed mechanisms include unopposed parasympathetic activation, enhanced vasovagal response to decreased venous return, and psychiatric stressors. the investigators prospectively will review patients candidates for spine surgery to explore potential incidence, contributory factors and outcomes to unexpected transient intraoperative haemodynamic instability, arrhythmia, and cardiac arrest during spine surgery as these data are needed to aid risk stratification and improve decision making for spine care teams.


Eligibility criteria:
inclusion criteria: 1. aged more than 18 2. gender: both. 3. asa grade i-ii (american society of anesthiologists). 4. prepared to spine surgery under general anesthesia exclusion criteria: 1. ischemic heart patients 2. hypertensive patients 3. patients with atrial fibrillation or any previous history of attack of arrhythmias 4. patients on b.b ( beta-blockers) 5. chronic use of neuropsychiatric medications 6. renal impairment 7. liver dysfunction. 8. any complications during the procedure as massive hemorrhage 9. surgery for traumatic spinal cord

Keywords: spine surgery , bradycardia , cardiac arrest
effects of earplugs on sleep and sleep apnea

Conditions: Sleep Disordered Breathing

Summary: the main goal of this study is to assess whether use of earplugs has any effect on sleep, sleep apnea, and daytime sleepiness in individuals who snore.


Eligibility criteria:
inclusion criteria: * adults, ages 18 or older * scheduled at the university of michigan sleep disorders center for a diagnostic polysomnogram to evaluate for sleep-disordered breathing exclusion criteria: * medical, psychiatric or other conditions that would interfere with interpretation of the results of the sleep studies or the subject's ability to complete the stanford sleepiness scale

Keywords: snoring, sleep disordered breathing, polysomnography, sleep fragmentation
the prognostic capabilities of a preoperative six-minute walk test to independently inform cardiovascular risk after major noncardiac surgery

Conditions: Noncardiac Surgery; Postoperative Myocardial Infarction; Postoperative Death; Risk Assessment

Summary: this prospective cohort study aims to determine whether the addition of the 6mwt to the rcri score improves the risk prediction of postoperative cardiovascular outcomes after noncardiac surgery. in addition, this study will assess whether the patients' reported met score corresponds to the determined met score from the 6mwt distance completed.

study investigators propose to undertake a prospective cohort study at the preoperative clinics of the royal-victoria and montreal general hospitals of mcgill university health centre. all patients with planned noncardiac surgery under general or regional anesthesia will be considered for inclusion. eligible consenting patients will undergo the 6mwt during their preoperative clinical visit, typically occurring within a few weeks before surgery. this test will be performed by a trained health care worker. patients will walk back and forth along a 20 m corridor, while attempting to cover as much ground as possible in 6 minutes. patients will be allowed to rest on the chairs while performing the test if necessary. patients will be encouraged to resume walking as soon as patients feel physically able. the total covered distance in 6 minutes will be measured to the nearest meter. the rcri score will be calculated for each study participant.

Eligibility criteria:
inclusion criteria: all patients fulfilling all the following inclusion criteria will be enrolled: * patients aged ≥ 50 year old and undergoing elective noncardiac surgery, under general anesthesia or regional anesthesia. * patients with planned surgery within 3 months of the preoperative visit. patients with at least one of the following medical conditions: * hypertension, diabetes mellitus, dyslipidemia, coronary artery disease, chronic kidney disease, transient ischemic attack, stroke, or peripheral vascular disease. exclusion criteria: patients meeting any of the following criteria will be excluded: * patients with a condition preventing mobilization for 6 minutes. * patients with significant cardiac disease (e.g., low-threshold angina (angina that occurs with minimal exertion), severe aortic stenosis). * patients with severe pulmonary disease restricting mobility. * patients refusing to participate. * patients previously enrolled in the study.
physiologic evaluation of anomalous right coronary artery stenosis

Conditions: Coronary Vessel Anomalies

Summary: the anomalous origin of right coronary artery (rca) is a rare coronary anomaly. recently, the detection of this anomaly has been more frequent as the use of cardiac multidetector computed tomography has become more popular. it can cause myocardial ischemia, syncope and sudden cardiac death. surgical repair is generally recommended for symptomatic patients. however, there is controversy concerning the proper evaluation and treatment strategy for patients without documented myocardial ischemia. the stenotic lesion of anomalous origin of rca will be assessed by fractional flow reserve (ffr).


Eligibility criteria:
inclusion criteria: * patients diagnosed as anomalous origin of right coronary artery from left coronary cusp exclusion criteria: * poor compliance * need for percutaneous coronary intervention to significant coronary lesion * failure of ffr for anomalous origin of right coronary artery

Keywords: coronary vessel anomalies
modified triple osteotomy for acetabular dysplasia

Conditions: Sharp Angle; Center Edge Angle; Femoral Head Extrusion Index; Center Head Distance Discrepancy

Summary: steel triple innominate osteotomy was designed for dysplastic hip in adolescents and young adults with three incisions to increase the coverage; however the amount of correction remained questionable due to ligamentous attachments that hinder the rotation. the investigators modified the technique with two anterior incisions and ramus cuts close to inferior acetabulum. the purpose of this study is to compare these two techniques in femoral head coverage


Eligibility criteria:
inclusion criteria: 1. symptomatic acetabular dysplasia in adolescent or young adult 2. closed triradiate cartilage 3. minor coxarthrosis with tonnis grades at 1 or 2 exclusion criteria: 1. high subluxation or complete dislocation of the hip joint 2. severe osteoarthrosis 3. combined with proximal femoral osteotomy that changed the femoral neck shaft angle (such as varus or valgus osteotomy)

Keywords: hip dysplasia triple osteotomy femoral head coverage femoral head medialization
study of sacituzumab govitecan-hziy and pembrolizumab versus treatment of physician's choice in patients with triple negative breast cancer who have residual invasive disease after surgery and neoadjuvant therapy (ascent-05/aft-65 optimice-rd/gbg 119/nsabp b-63)

Conditions: Triple Negative Breast Cancer

Summary: the goal of this study is to find out if the experimental product, sacituzumab govitecan-hziy (sg) in combination with pembrolizumab given after surgery, is effective and safe compared to the treatment of physician's choice (tpc) which includes either pembrolizumab or pembrolizumab plus capecitabine in participants with triple negative breast cancer that still remains after surgery and pre-surgical treatment.


Eligibility criteria:
key inclusion criteria: * age \> 18 years, with residual invasive triple negative breast cancer (tnbc) in the breast or lymph nodes after neoadjuvant therapy and surgery: * tnbc criteria for the study is defined as estrogen receptor (er) and progesterone receptor (pr) ≤ 10%, human epidermal growth factor receptor 2 (her2)-negative per american society of clinical oncology and college of american pathologists (asco/cap) guidelines (immunohistochemistry (ihc) and/or in situ hybridization (ish)). * adequate excision and surgical removal of all clinically evident of disease in the breast and/or lymph nodes and have adequately recovered from surgery. * submission of both pre-neoadjuvant treatment diagnostic biopsy and resected residual invasive disease tissue. * eastern cooperative oncology group (ecog) performance status 0-1. * individuals must have received appropriate radiotherapy and have recovered prior to starting study treatment. * adequate organ function. key exclusion criteria: * stage iv (metastatic) breast cancer as well as history of any prior (ipsi- or contralateral) invasive breast cancer. * prior treatment with another stimulatory or coinhibitory t-cell receptor agent (eg, cytotoxic t-lymphocyte-associated antigen 4 (ctla-4), ox-40, cluster of differentiation 137 (cd137), prior treatment with any her2-directed agent, prior endocrine therapy for \> 4 weeks or planned concurrent endocrine therapy while receiving on-study treatment. * evidence of recurrent disease following preoperative therapy and surgery. * prior treatment with topoisomerase 1 inhibitors or antibody-drug conjugates (adcs) containing a topoisomerase inhibitor. * individuals with germline breast cancer gene (brca) mutations. * myocardial infarction or unstable angina pectoris within 6 months of enrollment or history of serious ventricular arrhythmia (ie, ventricular tachycardia or ventricular fibrillation), high-grade atrioventricular block, or other cardiac arrhythmias or left ventricular ejection fraction (lvef) of \< 50% * active serious infections requiring anti-microbial therapy. note: other protocol defined inclusion/exclusion criteria may apply.

Keywords: aft-65 gbg 119 nsabp b-63 optimice-rd
transcatheter tricuspid valve interventions and right ventricular function: evaluation with magnetic resonance imaging

Conditions: Tricuspid Valve Insufficiency

Summary: there is an urgent need for transcatheter tricuspid interventions, as pharmaceutical therapy becomes ineffective in advanced disease stages and surgery remains associated with high mortality rates. despite the promising results, in some patients, although good procedural results were achieved, no clinical improvements were measured. right ventricular dysfunction is suspected to be the cause of the failed therapeutic strategy. therefore this study aims to analyze right ventricular function with magnet resonance imaging before and 3-months after the procedure in order to gain insight into the prevalence and dynamics of right ventricular dysfunction in severe tricuspid regurgitation and to identify possible predictors for treatment failure.


Eligibility criteria:
inclusion criteria: * patients with severe tricuspid regurgitation undergoing transcatheter tricuspid intervention. exclusion criteria: * patient with incompatibility with magnetic resonance imaging or echocardiography * another valve disorder that requires treatment * severe precapillary pulmonary hypertension * unstable angina or percutaneous coronary intervention within the last 30 days * previous pacemaker/defibrillator implantation with intracardiac leads * patients with cardiac cachexia or a life expectancy less then 12 months * allergies to the material used.