Kornimate/medical-research-clean huggingface dataset:
lh/hcg receptor expression and retrieval rates

Conditions: Subfertility

Summary: the purpose of this study is to evaluate if there is an association between the serum lh receptor expression on the day of hcg administration or the day of oocyte retrieval and the retrieval rates at oocyte pick up

the purpose of this study is to evaluate if there is an association between the serum lh receptor expression on the day of hcg or the day of oocyte retrieval and the retrieval rates at oocyte pick up. for this purpose, m-rna copy numbers will be assessed in the blood serum of patients undergoing ovarian stimulation for ivf on different days. furthermore, detailed ultrasound scans will be perfomed, as well as assesment of hormonal levels during ovarian stimulation.

Eligibility criteria:
inclusion criteria: * age \<39 years, * body mass index (bmi) between 18 and 29 kg/m2, * presence of both ovaries, * fsh levels \<10 iu/l. exclusion criteria: * endometriomas, * polycystic ovarian syndrome.

Keywords: subfertility, luteinizing hormone, receptor
children's healthy living community randomized trial

Conditions: Obesity; Acanthosis Nigricans; Central Obesity

Summary: the goal is to build social/cultural, political/economic, and physical/built environments that will promote active play and intake of healthy food to prevent young child obesity in the pacific region. our methods will support local culture in order to achieve this goal in these remote, underserved native populations. chl will engage the community, and focus on capacity building and sustainable environmental change. the focus of the chl community-based program is to promote healthy eating and to increase physical activity. in order to demonstrate effectiveness, the investigators will recruit and measure children in six communities selected in each of our jurisdictions in the pacific. these represent intervention communities, comparison communities, and temporal communities.

the specific objectives of our study are as follows. objective. decrease the prevalence of young child overweight and obesity; and its functional outcomes (decrease acanthosis nigricans, and increase sleep; increase moderate to vigorous physical activity and decrease sedentary behavior (screen time); increase healthy eating (fruit and vegetable intake, water intake; decrease sweetened beverage intake), through community-based primary prevention environmental interventions in the pacific region. objective. measure 2-8-year-old children at baseline and 24 months in selected communities to track behaviors and anthropometry that indicate healthy eating, physical activity, and bmi. objective. measure 2-8 year old children at 78 months in the selected communities to determine the long term effect of the chl program.

Eligibility criteria:
inclusion criteria: * community criteria four (4) to six (6) communities in each of five (5) jurisdictions (alaska, american samoa, commonwealth of northern mariana islands, guam \& hawai'i) chosen for community randomized program based on: * 2000 u.s. census criteria * \>1000 people * \>25% native population, * \>10% under 5y * chl staff community evaluation * sufficient head start/preschool, kindergarten * children live \& go to school in area * separation between communities to allow testing * access for chl * sufficient community cohesiveness * sufficient settings for program (community centers, parks, stores...) * child criteria • 2-10 years of age exclusion criteria: * child criteria * known orthopedic, psychological or neurologic impairments that prevent physical activity * presence or history of any metabolic or chronic health problems known to affect intermediary metabolism (e.g. untreated thyroid disease, cancer, hepatic disease, renal disease, diabetes, cardiovascular disease, hypertension) * irregular use of prescription or over-the-counter medications known to affect appetite, food intake or intermediary metabolism (e.g. appetite suppressants, lithium, antidepressants, etc.)

Keywords: obesity child food physical activity pacific
evaluation of intestinal permeability in cirrhotic patients before and after treatment with non-selective beta blocker (propranolol)

Conditions: Liver Cirrhoses

Summary: this study seeks to investigate whether non-selective beta blocker treatment decreases intestinal permeability in cirrhotic patients by altering the expression of genes encoding intercellular junction proteins.

there is evidence that the non-selective beta-blocker (nsbb) propranolol reduces intestinal permeability and decreases bacterial translocation in cirrhotic patients, independent of hemodynamic effects on portal pressure. the mechanism by which this decrease in intestinal permeability and bacterial translocation occurs has not been established. among the proposed mechanisms are: modification of splanchnic hemodynamics, increased gastrointestinal motility, and immunological properties of nonselective beta blockade. it is not known, however, if beta-blocker treatment decreases intestinal permeability by altering the expression of genes encoding intercellular junction proteins. this study seeks to investigate this question to improve understanding of the mechanism by which beta-blockers work in primary and secondary prophylaxis of variceal hemorrhage.

Eligibility criteria:
inclusion criteria: * \> 18 years * diagnosis of cirrhosis of any etiology or severity as established by the treating physician (biopsy, biochemical, imaging) * high risk gastroesophageal varices, that is those with medium/large varices or any size varices with red wale signs * scheduled appointment for endoscopic ligation as previously ordered by the treating physician * signed informed consent * ability to keep return appointments exclusion criteria: * beta blocker treatment within 1 month prior to study period * antibiotic treatment during or within 1 month prior to study period * prebiotic or probiotic treatment during or within 1 month before study period * current immunosuppressive treatment * patients with active infectious process * patients with portal thrombosis * patients with hepatocellular carcinoma * patients with intestinal surgical shunts * patients with chronic diarrhea or documented celiac disease * patients with chronic renal failure (kdoqi: ≤ 3) * patients with allergy or absolute contraindication for the use of nonselective beta blockers (asthma, significant heart block, systolic bp \<90 mm hg, basal hr \<55, refractory ascites)

Keywords: cirrhosis variceal bleeding non-selective beta blocker intestinal permeability gene expression bacterial translocation
dolutegravir plus lamivudine simplified therapy

Conditions: HIV/AIDS

Summary: dolutegravir (dtg) is one type of integrase inhibitor, lamivudine (3tc) is one type of reverse transcriptase inhibitor, both of which are hiv medicine prevents hiv from self-multiplying, reduces the viral load. the data of the existing randomized controlled clinical studies show that the simplified two-drug dtg-based regimen is similar to the three-drug regimen in terms of efficacy, but there are no relevant data and reports on the efficacy and safety of dtg+3tc in hiv-infected patients in china so far. this project aims to explore the efficacy and safety of the dtg + 3tc regimen for hiv-infected patients in real clinical environment, to guide clinical application, and to provide a theoretical basis for the selection of simplified schemes for the formulation of guidelines. this study was done to see if the combination of two anti-hiv medicines, dolutegravir (dtg, tivicay) and lamivudine (3tc, epivir) taken once a day, provide a safe, effective, and well-tolerated treatment for hiv.

this study is an open-label, multicentered, single-arm and phase iv clinical trial. 300 hiv-infected patients who received simplified treatment regimen (50mg dtg+ 400mg 3tc, oral, qd) were selected to observe the treatment efficacy. at week 24, 36, 48 and 96, the rate of viral suppression and cd4 cell count were calculated against baseline. in addition, the safety and drug compliance were also monitored.

Eligibility criteria:
inclusion criteria: 1. age (\> 18 years), male and female; 2. hiv-1 infected; 3. using a standard three-drug-based regimen for at least 24 weeks. based on clinical decision making\* decide if patients can be treated with the dtg+3tc simplified scheme for a variety of reasons, such as (but not limited to): patients cannot tolerate the conventional three-drug treatment scheme, renal insufficiency, osteoporosis, bone marrow suppression and for other reasons patients cannot use the conventional three-drug treatment scheme; 4. initial hiv-1 rna viral load and cd4 cell count were unlimited. 5. cd4 can be monitored at least three times in the first year (including baseline, 24 weeks of treatment and 48 weeks of treatment). after the first year, cd4 can be detected at least once every six months. 6. state informed consent for free treatment has been signed; 7. good compliance and signing informed consent (\* reference criteria: refer to apsire study, creatinine clearance rate (\> 50 ml/min), no dtg/3tc allergy history, hbsag negative, no chronic liver disease, no severe liver damage, no pregnancy during the study) exclusion criteria: 1. has participated in other clinical trials of hiv vaccine or other drug trials in the past three months; 2. researchers decide if patients could/not complete the scheduled follow-up (factors to consider such as weak, poor compliance, etc.). 3. has a clear history of dtg or 3tc allergy; 4. hbsag and/or hbv-dna positive; 5. pregnancy during the study period.

Keywords: dtg + 3tc simplified therapy simplified therapy regimen real world study hiv-1-infected patients
an open label extension study of stx209 in subjects with autism spectrum disorders

Conditions: Autism Spectrum Disorders

Summary: study 22003, "an open-label, flexible-dose evaluation of the safety and tolerability of stx209 for treatment of irritability in subjects with autism spectrum disorders(asd)" currently is evaluating the efficacy of stx209 (r-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with asd. this study (22007) will enter subjects who complete study 22003 into a long-term, open-label study.the open-label extension protocol will provide necessary data on the long-term safety and tolerability of stx209 among subjects with asd who receive treatment under conditions more closely reflective of their general medical care.


Eligibility criteria:
inclusion criteria: * have completed all scheduled visits in protocol 22003 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with stx209, as assessed by the principal investigator exclusion criteria: * subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. * the occurrence or continuation of any adverse event or condition during study 22003 that, in the opinion of the investigator, should exclude the subject from participating in this open-label extension

Keywords: autism
negative pressure in pap donor sites

Conditions: Breast Reconstruction

Summary: a retrospective chart review will be conducted to identify patients who received breast reconstruction using free profunda artery perforator (pap) flap by the investigators from january 2015 to august 2021. the included patients will be grouped into two according to the application of incisional negative pressure wound therapy (np) on the donor site. patients' demographic data including their age at the surgery, body mass index (bmi), medical comorbidities including the hypertension and diabetes, and smoking history will be obtained from the retrospective chart review. parameters of the flap will be carefully reviewed, including the flap harvested width, and flap harvested length, the flap harvested and used size, the size of the mastectomy, the ischemia time of the flap. the major interest is in the donor site management and patient's overall recovery. the complications of the donor site will be categorized into acute and chronic ones depending on the time of presence. donor site complications, such as wound break down, hematoma, seroma, the total amount of the drainage will be recorded. the cutting time point for acute and chronic complications is 1 month. the total amount of drainage from the drainage tube inserted and the patients' off-bed time (day) will also be recorded. besides, for patients with follow up time of more than 1 year, the scar will be evaluated using vancouver scar scale. statistics data will be analyzed using graphing and statistical analysis software spss 21 software (ibm, chicago, illinois, usa). rank sum and independent t test will be applied to calculate continuous variables in demographic values, while chi-square will be applied to calculate categorical variables such as postoperative complications. a probability of less than 0.05 will be considered significant. potential risks: no confidentiality: all the patient identifiable information, which includes name, chart number and birthday, involved in the study will be strictly confidential.


Eligibility criteria:
inclusion criteria: * patients who underwent unilateral microsurgical breast reconstruction using pap flaps from the pi (jjh) from november 2016 to august 2020 exclusion criteria: * patients with delayed reconstruction

Keywords: breast reconstruction profunda artery perforator flap tensioned wound healing negative pressure
ovatio crt and situs otw lv lead post approval study

Conditions: Heart Failure

Summary: post approval study measuring safety outcomes on the ovatio crt-d and situs otw lv lead over 5 years.


Eligibility criteria:
inclusion criteria: * nyha class iii/iv * stable medical regimen * qrs greater than or equal to 130 ms * lvef less than or equal to 35% exclusion criteria: * vt of transient or reversible causes * incessant vt * currently implanted with a lead positioned through the coronary sinus (unless it is the situs otw lv lead) * cardiac revascularization or angioplasty within the last month * heart failure due to correctable valve disease * chronic, medially refractory at * enrolled in another clinical study that may confound the results of this study * life expectancy less than 6 months * inability to understand the purpose of the study or refusal to cooperate * inability or refusal to provide informed consent * unavailable for scheduled follow-up with the implanting practice * sensitivity to 1 mg dexamethasone sodium phosphate * less than 18 years of age * pregnancy

Keywords: heart failure cardiac resynchronization therapy
neutrophil gelatinase-associated lipocalin vs vascular calcification in maintenance hemodialysis patients

Conditions: Chronic Kidney Disease-Mineral and Bone Disorder

Summary: the goal of this observational study or clinical trial is to learn about the effect of neutrophil gelatinase-associated lipocalin (ngal) on vascular calcification in maintenance hemodialysis patients with secondary hyperparathyroidism (shpt). the main question it aims to answer is: the predictive effects of blood ngal level on the efficacy of palicalcitol in the treatment of shpt and the adverse reactions of vascular calcification progression. participants will be treated with palicalcitol, followed up and undergo routine series of chronic kidney disease-mineral and bone disorder associated tests before and after treatment.

1. sample size calculation: because there was no previous study on the change of blood ngal level in mhd patients with palicalcitol; refer to the ngal changes before and after parathyroidectomy :n=12 ngal715.84(578.73, 988.14)ng/ml before and 688.42(660.00, 760.26)ng/ml 4-7 days after surgery (p=0.071, paired t-test). according to the 20% loss rate; the sample size is finally determined to be 80 cases. 2. patients: maintenance hemodialysis patients with secondary hyperparathyroidism (shpt). 3. palicalcitol injection 4. follow-up the patients are followed up for 1 year. 5. statistical methods all statistical tests are conducted by two-sided test, and the first type of error is 0.05 (α value) to determine the statistical significance of the difference. quantitative data includ efficacy, laboratory test indicators, such as the number of cases, mean, median, standard deviation and range description. qualitative data includ comorbidities, described in terms of frequency, composition or percentage. statistical test: the parameter test method is preferred. if the data distribution differs greatly from the requirements of testing the hypothesis, the non-parameter test method will be used. patients will be divided into two groups according to circulating ngal levels before treatment; the clinical characteristics, changes of ngal level, the efficacy of palicalcitol (changes of ipth) and the main adverse reactions (increased blood calcium and phosphorus, progress of vascular calcification) are compared between two groups. t test or rank sum test are used for difference test. the correlation between blood ngal level, vc score and ckd-mbd assay indexes is analyzed by pair-wise correlation and logistic multivariate regression.

Eligibility criteria:
inclusion criteria: * chronic kidney disease (ckd) maintenance hemodialysis patients with secondary hyperparathyroidism (shpt), ipth\>300pg/ml * age 18-65 years old * haven't used anti-pth agents within 3 months * signed informed consent exclusion criteria: * allergic to vitamin d or similar drugs * vitamin d poisoning * expected survival is less than one year * acute inflammations, active liver disease, tumor, hospitalization within 3 months * fractures, major trauma or operations within 3 months.

Keywords: chronic kidney disease-mineral and bone disorder calcitriol receptor lipocalin-2 vascular calcification
chimney endovascular aneurysm sealing of new expanded indication

Conditions: 1 Paravisceral Abdominal Aortic Aneurysm; 2 Juxtarenal Abdominal Aortic Aneurysm; 3 Pararenal Abdominal Aortic Aneurysm; 4 Complex Abdominal Aortic Aneurysms

Summary: prospective, multi-center, non-randomized study with consecutive, eligible subject enrollment at each site, for the evaluation of the chevas system for endovascular repair of complex abdominal aortic aneurysms.

this is a prospective multicenter study with consecutive eligible subject enrollment at each site. enrollment will include up to 150 subjects (120 chevas subjects and up to 30 infrarenal roll-in subjects). the chevas study will evaluate the safety and effectiveness outcomes following appropriate government and ethics committee/irb requirements and guidelines. all enrolled (chevas and infrarenal) subjects will undergo a high resolution, contrast-enhanced computed tomography angiography (ct) scan of the relevant aortic and aortoiliac vasculature within three months of the scheduled procedure and at specified follow-up intervals post-implantation. follow-up visits will occur at 30-days, 6-months, and annually to 5-years to assess aneurysm morphology, the status of the implanted devices, and relevant laboratory test results. \*as of october 27, 2021 chevas one study is voluntarily closed to screening and consenting. 13 subjects enrolled in the study will continue to be observed through 5-years.

Eligibility criteria:
inclusion criteria: * adults at least 18-years old * subject provided informed consent * subject agrees to all follow-up visits * abdominal aortic aneurysm (aaa) with maximum sac diameter ≥5.0 cm, or ≥ 4.5 cm which has increased by ≥ 0.5cm within the last 6-months, or which exceeds 1.5 times the transverse dimension of an adjacent non-aneurysmal aortic segment. no aaa \<4cm will be included * absence of significant cranial angulation of the visceral vessels that would preclude vessel cannulation and stenting exclusion criteria: * requirement of home oxygen * psychiatric or other condition that may interfere with the study * participating in another clinical drug and/or device study, which could confound the results of this study (patient must have completed the primary endpoint of any previous study at least 30-days prior to enrollment in this study) * known allergy or contraindication to any device material, contrast, or anticoagulants * serum creatinine level \>1.8mg/dl * cva or mi within three months of enrollment/treatment * prior stent in any target visceral vessel, the aorta or iliac artery that may interfere with delivery system introduction or stent placement * connective tissue diseases (e.g., marfan syndrome) * unsuitable vascular anatomy that may interfere with device introduction or deployment * pregnant, planning to become pregnant within 60 months, or breast feeding.

Keywords: paravisceral abdominal aortic aneurysm juxtarenal abdominal aortic aneurysm pararenal abdominal aortic aneurysm complex abdominal aortic aneurysm abdominal aortic aneurysm
aav2/8-lsphgaa (actus-101) in late-onset pompe disease

Conditions: Pompe Disease

Summary: open-label, ascending dose trial of actus-101 administered intravenously.

this study will be a prospective, open-label trial designed to objectively assess the safety and bioactivity of actus-101 in subjects diagnosed with pompe disease, which is caused by a defect in acid α-glucosidase (gaa) gene. actus-101 is intended to enable expression of a functional copy of the gaa gene in subject's hepatocytes.

Eligibility criteria:
inclusion criteria: * diagnosis of pompe disease by blood or skin fibroblast gaa assay and two pathogenic variants in the gaa gene, * age: greater than or equal to 18 years at enrollment. * subjects are capable of giving written informed consent. * able to walk at least 100 meters on the 6mwt (with assistive devices permitted). * fvc within the range of 30% to less 90% (inclusive) of predicted in the upright position. * subjects with a confirmed diagnosis of lopd who have been treated with ert for at least 104 weeks (inclusive) immediately preceding screening and receiving a stable dose of ert for the 52-week period immediately preceding dosing. exclusion criteria: * invasive ventilation required or noninvasive ventilation required while awake and upright. * fvc \<20% of predicted (supine). * received any live vaccination 2 months prior to study day 1. * pregnant or nursing mothers. * serology consistent with exposure to hiv, or serology consistent with active hepatitis a, b or c infection. any active liver disease. * active infection based upon clinical symptoms. * having started respiratory muscle strength training in the last 6 months prior to study day 1 or having discontinued respiratory muscle strength training in the 6-month period preceding study day 1, or having started respiratory strength training greater than 6 months prior to study day 1 and unwilling to continue for the first year of study participation. * received an investigational drug or participated in another interventional study within 90 days prior to study day 1. additionally, subjects cannot participate in any other interventional clinical trial throughout the first 78 weeks after receiving actus-101.

Keywords: gene therapy