Kornimate/medical-research-clean huggingface dataset:
aortic regurgitation after surgical repair of outlet-type ventricular septal defect

Conditions: Heart Septal Defects, Ventricular; Aortic Valve Insufficiency

Summary: the major risk factors of aortic valve replacement in three outlet types vsd after surgical repair were the severity of preoperative ar and older operation age. for those patients with less than moderate degree ar preoperatively, ar progressed rarely and all in those with aortic valvar and subvalvar anomalies.

progression of aortic regurgitation (ar) in repaired outlet (juxta-arterial, muscular outlet and perimembranous outlet) ventricular septal defect (vsd) remains unclear. from 1987 to 2002, 411 patients with complete follow-up after repair of outlet vsd constituted the study population. study end point was aortic valve replacement or mortality. aortic valve replacement was performed in seventeen patients (4.1%), in whom logistic regression showed only the severity of preoperative ar and age at vsd repair as the predictors. after excluding the eleven patients with endocarditis from analysis, there were 377 patients with none to mild ar (group i) and 23 with moderate to severe ar (group ii) preoperatively. total follow-up was 2,230 person-years. after vsd repair, the 5- and 10-year freedom from aortic valve replacement in group i was 100%, and in group ii 50.2%. in group ii, ten patients received aortic valve replacement and 8 underwent valvuloplasty with vsd repair. one patient needed valve replacement four years later. age at vsd repair was the predictor for aortic valve replacement. in group i, ar progressed in four patients (1.2%, two juxta-arterial and two perimembranous outlet) 3.5 to 7.9 years later and was associated with aortic valvar or subvalvar anomalies. the event-free curves in three outlet types vsd showed no differences. although ar progressed rarely (probably not in muscular outlet type) in repaired outlet types vsd with none to mild preoperative ar, in the presence of aortic valvar or subvalvar anomalies, early surgical repair of the vsd is still warranted.

Eligibility criteria:
inclusion criteria: * ventricular septal defect patients receiving total repair from jan, 1987 to dec, 2002. * follow up more than 1 year after operation exclusion criteria: * complex cardiac lesions

Keywords: ventricular septal defect aortic regurgitation
pili 'ohana project: partnerships to overcome obesity disparities in hawaii (3-year pilot)

Conditions: Overweight; Obesity

Summary: the pili 'ohana cbpr partnership implemented a pilot study to determine whether a family plus community focused intervention will improve weight loss maintenance compared to standard follow-up in overweight/obese native hawaiian (nh) and other pacific people (pp) adults (\> 18 yr. old) after receiving a standard individual-focused behavioral intervention. the primary hypothesis was that overweight/obese nh and pp adults that undergo a combined family-focused plus community-focused intervention vs. a standard follow-up after receiving a standard individual-focused behavioral intervention will have significantly higher rates of weight loss maintenance.

the long term mission of the pili 'ohana program is to integrate community wisdom and expertise with scientific methods to conduct research on health disparities with a specific emphasis on obesity in nhs and pps. recognizing that recent advances in medicine such as the reduction of cardiovascular disease mortality and the prevention of type 2 diabetes mellitus, have not translated into benefits for all sectors of the u.s. population, especially ethnic and racial minority populations, the pili 'ohana program aims to address this gap through community-academic partnerships focused on interventions to promote change in obesity-related disparities in nh and pp communities. one of the scientific goals of the pili 'ohana program focused on designing and implementing research activities aimed at completing a pilot intervention study to provide the basis for a more definitive, hypothesis-driven 5-year research study in the future.

Eligibility criteria:
inclusion criteria: * native hawaiian, filipino or other pacific islander ethnic background; * age 18 years or older; * overweight or obese defined as bmi \> 25 kg/m2 (nh or pacific islanders) or \> 23 kg/m2 (filipino ethnic background); * willing and able to follow a behavioral weight loss intervention program that could potentially include 150 minutes of brisk walking per week (or equivalent) and a dietary regimen designed to induce weight loss of \~1-2 lbs per week; * able to identify at least 2-3 family, friends or co-workers that would be willing to support the participant during the course of the study. exclusion criteria: * survival less than 6 months; * planning to move out of the community during the intervention study period (16 months); * pregnancy; * any dietary or exercise restrictions that would prevent an individual from fully participating in the intervention protocol (i.e. end stage renal disease on a renal diet, etc.); * any co-morbid condition (physical and mental disabilities) that would prevent the individual from participating in the intervention protocol (i.e. severe arthritis, hemi-paresis, major psychiatric illness, eating disorders, etc.).

Keywords: non-blind, randomized controlled trial pilot study
treatment of thoracic outlet syndrome (tos) with botox

Conditions: Thoracic Outlet Syndrome

Summary: the purpose of this study is: 1. to assess the effect of botox injection to the scalene muscles on the severity of pain from tos. 2. to assess the effect of botox injection on numbness and tingling and quality of life.

background: thoracic outlet syndrome (tos) is a symptom complex consisting of pain, paresthesias and often functional impairment caused by compression of the neurovascular supply to the upper limb. impingement may occur at the interscalene triangle, and both anesthetic blockade and chemodenervation of the scalene muscles have been shown to temporarily improve symptoms of tos in non-randomized controlled trials. objective: to assess the effect of botulinum toxin type a (btx-a) injections into the scalene muscles on pain, paresthesias and function in subjects with tos. hypothesis: btx-a injected into the anterior and middle scalene muscles will reduce the irritation on the neurovascular structures at the interscalene triangle in subjects with tos. this will lead to reductions in pain and paresthesias, and improvements in function when compared with injection of placebo. intervention: each subject will receive an injection under emg guidance into the anterior and middle scalene muscles of either 75 units of btx-a (experimental group), or normal saline (control group). both groups will be provided with a stretching and strengthening exercise program.

Eligibility criteria:
inclusion criteria: * age at least 19 years * medically stable * able to give informed consent * meets criteria for clinical diagnosis of tos * symptoms of tos present for at least six months * have had emg studies and a ct or mri scan of the cervical spine exclusion criteria: * prior treatment with btx-a * allergy to btx-a * history of botulinum toxicity * prior scalenectomy * surgery for tos planned within six months * use of blood thinners, i.e., warfarin; unfractionated or low molecular weight heparin * history of myasthenia gravis, eaton-lambert syndrome or shy-drager syndrome * unable to complete follow-up assessments at 6 weeks, 3 months and 6 months * any abnormalities on emg, ct or mri studies suggesting an alternate diagnosis * pregnancy or planned pregnancy within six months

Keywords: thoracic outlet syndrome (tos) botulinum toxin botox pain
identification of microplastics in liver, stomach, blood, and feces of obese patients and their association analysis with macrogenomics and metabolomics.

Conditions: Obesity and Overweight

Summary: the aim of this study was to identify and quantify microplastics in the stomach, liver, feces, and blood of obese patients to be treated with bariatric surgery by using a variety of advanced analytical techniques to explore the association between obesity and visceral microplastics, and to investigate the effects of microplastics on the visceral microbiota and metabolic profiles of obese patients by combining the macro-genomic and metabolomics approaches.


Eligibility criteria:
inclusion criteria: * age ≥18 years old; * bmi ≧30; * proposed to undergo bariatric surgery and need to remove part of the liver tissue for fatty liver test; * complete clinical data and basic information; * willing to participate in the study and sign the informed consent form. exclusion criteria: * receive chemotherapy, radiotherapy, immunotherapy; * have other history of digestive diseases; * combined with malignant tumors; * have serious cardiorespiratory insufficiency and other systemic diseases that affect the choice of treatment plan; * not willing to participate in this study.

Keywords: microplastics obesity macro-genomic metabolomics
24-hour iop-lowering effect of 0.01% bimatoprost

Conditions: Intraocular Pressure; Glaucoma; Ocular Hypertension

Summary: this study will evaluate the 24-hour iop-lowering efficacy of 0.01% bimatoprost once daily in patients with glaucoma or ocular hypertension

objectives to investigate the 24 h effects of bimatoprost 0.01% monotherapy on intraocular pressure (iop) and ocular perfusion pressure (opp). design prospective, open-label experimental study. setting single tertiary ophthalmic clinic. participants sixteen patients with diagnosed primary open-angle glaucoma (poag) or ocular hypertension (ages, 49-77 years). interventions baseline data of 24 h iop in untreated patients were collected in a sleep laboratory. measurements of iop were taken using a pneumatonometer every 2 h in the sitting and supine body positions during the 16 h diurnal/wake period and in the supine position during the 8 h nocturnal/sleep period. after baseline measurements were taken, patients were treated with bimatoprost 0.01% one time per day at bedtime for 4 weeks, and then 24 h iop data were collected under the same laboratory conditions. primary outcome measure of nocturnal iop mean under bimatoprost 0.01% treatment was compared with baseline.

Eligibility criteria:
inclusion criteria: * primary open-angle glaucoma or ocular hypertension exclusion criteria: * women of childbearing potential previous glaucoma surgery presence of other eye disease
effect of semaglutide on the psoriatic lesions in patients with type 2 diabetes mellitus

Conditions: Psoriasis Vulgaris; Diabetes Type 2

Summary: the use of semaglutide in patients with dmt2 and psoriasis contributes to improving the clinical picture of psoriasis and reducing the inflammatory response

after being informed about the study and potential risiks all patients giving written informed consent will undergo a 1-week screening period to determine eliglibility for study entry at week 0, patients who meet the eligibility requirements will be randomized. study was conducted in two cohort cohort 1. patients with dmt2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and to whom semaglutide will be introduced into the therapy, in the maximum tolerated dose of semaglutide (0.25mg, 0.5mg per week or 1.0mg per week). cohort 2. patients with dmt2 and psoriasis, who are already on metformin therapy in the maximally tolerated dose and other oral antidiabetics, except on therapy with glp-1 ra and sglt-2 inhibitors.

Eligibility criteria:
inclusion criteria: * patients who signed a personal consent to participate in the study, * patients with a typical clinical picture of moderately-severe to severe plaque psoriasis (pasi score ≥10) and * dmt2 diagnosed at least 6 months before inclusion in the study, * patients who were not treated with immunosuppressive therapy. exclusion criteria: * other forms of psoriasis, * other chronic, inflammatory diseases (data obtained by reviewing the medical history), * drugs that can cause the appearance of psoriasis (lithium, systemic antimalarials, systemic corticosteroids) - for the past 3 months, * systemic therapy of vulgaris psoriasis 3 months before inclusion in the study, * patients on therapy with other glp-1 ras except semaglutide (liraglutide, dulaglutide, lixisenatide), sglt-2 inhibitors (empagliflozin and dapagliflozin) and nsaids, photo uvb therapy, * patients who did not personally sign consent to participate in the study.

Keywords: psoriasis diabetes type 2 semaglutide cytokine
a study of single agent pemetrexed disodium in treating patients with recurrent or persistent ovarian or primary peritoneal cancer

Conditions: Ovarian Cancer; Peritoneal Cancer

Summary: the primary purpose of this trial is to estimate the drug effect on tumors in patients with ovarian or primary peritoneal cancers. patients will receive pemetrexed every 21 days until disease progression or unacceptable toxicity. this medication will be given over 10 minutes and may be administered intravenously (iv), through a vein in your arm. vitamin supplementation is a required part of this study.


Eligibility criteria:
inclusion criteria: * histologically confirmed recurrent or persistent disease ovarian epithelial or primary peritoneal cancer * measurable disease * must have received 1 prior platinum-based (carboplatin, cisplatin, or another organoplatinum compound) chemotherapy regimen for primary disease. patients who had not received prior paclitaxel may have received a second regimen that included paclitaxel * treatment-free interval \< 6 months after prior platinum-based therapy or progressed during platinum-based therapy * not eligible for a higher priority gynecologic oncology group (gog) protocol (i.e., any active phase iii gog protocol for the same patient population) exclusion criteria: * patients who have had prior therapy with pemetrexed * patients with a history of other invasive malignancies, with the exception of non-melanoma skin cancer, are excluded if there is any evidence of other malignancy being present within the last five years. patients are also excluded if their previous cancer treatment contraindicates this protocol therapy. * patients who have received radiation to more than 25% of marrow
prospective study to compare a limited versus extended pelvic lymphadenectomy during prostatectomy

Conditions: Prostate Cancer

Summary: this study examines limited versus extended pelvic lymphadenectomy.

this study is meant to show if the extension of lymphadenectomy during prostatectomy has an influence of outcome of patients. patients with indication to prostatectomy due to prostate cancer will be included. both extensions of lymphadenectomy are used in hospitals as a free choice. this study shell show if one method is more effective than the other.

Eligibility criteria:
inclusion criteria: * stamp bioptic secured prostate cancer with intermediate or high risk profile (defined as gleason-score 7-10 or psa \> 10 ng/ml) * locally-operable tumor according to dru/trus * negative bone scan * negative ct abdomen / pelvis * general condition according to karnofsky \>/= 80% * written consent of the patient * adequate hematological, renal and coagulation physiological functions * patient compliance and geographic proximity to allow adequate follow-up exclusion criteria: * manifest secondary malignancy * secured metastasis by histologically or by imaging * myocardial infarction or stroke within the last 6 months * existing major cardiovascular (grade iii - iv according to nyha), pulmonary (po2 \<60 mmhg), renal, hepatic or hematopoietic (eg severe bone marrow aplasia) diseases * severe active or chronic infections (eg pos. hiv-ab test, hbs-ag detection in serum and / or chronic hepatitis) * severe psychiatric disease * prior chemotherapy (allowed is a preoperative antiandrogen therapy ≤ 3 months) * previous pelvic radiotherapy * patients in a closed institution according to an authority or court decision * people who are in a dependent relationship or working relationship with the sponsor or investigator * simultaneous participation in another clinical trial

Keywords: lymphadenectomy prostate cancer
yttrium-90 anti cd66 monoclonal antibody in childhood relapsed/refractory leukaemia

Conditions: Acute Myeloblastic Leukemia; Acute Lymphoblastic Leukemia; Juvenile Myelomonocytic Leukemia

Summary: the radio-labeled anti-cd66 monoclonal antibody (with 111in for dosimetry and 90y for therapy) will be administered in the t11 north room, uclh, while the reduced intensity conditioning regimen and the allogeneic hematopoietic stem cell transplant will be performed in 2 centers, according to the age of the patient: a) patients aged \< 13 years will be transplanted at the bone marrow transplantation department, great ormond street hospital (gosh), and b) patients aged 13-18 years will be transplanted at the bone marrow transplantation department, university college london hospitals (uclh).


Eligibility criteria:
inclusion criteria: 1. an underlying haematological malignancy including: 1. isolated bone marrow relapse of aml after allogeneic haematopoietic stem cell transplantation; 2. isolated bone marrow relapse of all after allogeneic haematopoietic stem cell transplantation; 3. bone marrow relapse of jmml after allogeneic haematopoietic stem cell transplantation; 4. refractory aml (5-20% blasts in bm) with/without expression of cd66 on blasts; 5. refractory all (5-20% blasts in bm) with/without expression of cd66 on blasts; 6. refractory aml (\> 20% blasts in bm) with expression of cd66 on blasts; 7. refractory all (\> 20% blasts in bm) with expression of cd66 on blasts; 2. be ≥ 1 year old and ≤ 18 years old; 3. must not be eligible for therapy of higher curative potential. where an alternative therapy has been shown to prolong survival in an analogous population, this should be offered to the patient prior to discussing this study; 4. have a karnofsky performance status ≥ 50 or lansky performance status ≥ 30; 5. provide signed, written informed consent from parent or guardian; 6. be able to comply with study procedures and follow-up examinations; 7. have normal cardiac function without specific treatment; 8. have adequate organ function (as indicated by table 3, chapter 5), within 30 days prior to 111in infusion; 9. patients who have received any other chemotherapy within the previous 2 weeks and must have recovered from acute toxicity of all previous therapy prior to enrolment; 10. be negative for human-anti-murine antibodies (hama). exclusion criteria 1) patients with cns disease; 2) patients with bm cellularity \< 10%; 3) patients with ≥ 20% blasts in bm and no expression of cd66 on blasts; 4) patients who are positive for human-anti-murine antibodies (hama); 5) patients with compromised organ function (as indicated by table 3, chapter 5), within 30 days prior to 111in infusion; 6) patients with extensive chronic gvhd; 7) patients with an active, uncontrolled systemic infection considered opportunistic, life threatening, or clinically significant at the time of treatment; 8) patients who are pregnant or lactating; 9) patients with any other severe concurrent disease, which, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
dopamine versus dobutamine for treatment of arterial hypotension in term and preterm neonates

Conditions: Arterial Hypotension

Summary: the purpose of this study is to examine the effects of dobutamine as compared to dopamine in term and preterm neonates with arterial hypotension on cerebral and renal oxygenation, fractional tissue oxygen extraction, mean arterial blood pressure and cardiac output. the investigators hypothesize that dopamine has a stronger effect on blood pressure than dobutamine but dobutamine has a stronger effect on cerebral oxygenation and cardiac output than dopamine.


Eligibility criteria:
inclusion criteria: * fluid refractory arterial hypotension * newborn infant below 44 weeks postmenstrual age * parental informed consent exclusion criteria: * preterm infant below 28 weeks postmenstrual age during the first week of life * congenital life-threatening malformations * decision for palliative care * hemorrhagic shock * other obvious cause for arterial hypotension that requires immediate specific treatment, e.g. tension pneumothorax
effects of omega-3 fatty acids on bone and frailty

Conditions: Osteoporosis; Frailty

Summary: the purpose of this study is to examine the effects of essential fatty acid (efa) supplementation on bone metabolism and frailty in postmenopausal women. the overall hypothesis is that efa supplementation, via its immunoregulatory and anti-inflammatory activity, will decrease bone turnover, decrease prostaglandins and cytokines associated with bone metabolism and frailty, and change physical outcome measures associated with frailty in postmenopausal women with low bone mass and frailty.

osteoporosis is a bone thinning disease that results in fractures that occur with minimal trauma. the direct health care costs related to osteoporosis are estimated to be $14 billion per year, comparable to costs in heart failure and asthma. frailty, or poor physiologic reserve to deal with stressors, is estimated to be 7% in the general population over age 65. the frailty syndrome is characterized by sarcopenia or muscle loss, inflammation, low estrogen, growth hormone and testosterone levels, poor nutrition and disability, and is associated with an increased risk of falls and fracture. omega-3 fatty acids found in fish oil (eicosapentaenoic acid (epa) and docosahexaenoic acid (dha)) have been shown to decrease markers of inflammation (cytokines) and decrease death due to heart disease. a number of studies in animals suggest that fish oil (epa and dha) supplementation inhibits bone break down, increases calcium absorbed from the diet and enhances calcium in bone. few studies have assessed the role of n-6 and n-3 fatty acids in the diet in bone disease in humans. as far as we know, no study has evaluated the role of n-3 fatty acids in the frailty syndrome.

Eligibility criteria:
inclusion criteria: * postmenopausal women over 65 years old * spine or hip bone density t score less than -1 * hand grip strength 2 standard deviations below weight adjusted norms * able to travel to the clinical sites for follow-up visits exclusion criteria: * any disease that may affect bone metabolism, (i.e paget's disease, primary hyperparathyroidism) * cancer of any kind (except basal or squamous cell of skin) in past 5 years. * use of calcitonin, calcitriol, heparin, phenytoin, phenobarbital, and estrogen in the past 6 months * use of bisphosphonates, long-term corticosteroids (more than 6 months), methotrexate, or fluoride at any time * current use of any medication or herbs with anticoagulant or antiplatelet activity, tetracycline, and magnesium or zinc supplementation * estimated creatinine clearance less than 50 ml/min * history of chronic liver disease or evidence of liver disease on screening * history of hip fracture or known vertebral fracture within the past year * untreated hypertension or a history of clotting disorders * history of allergy to fish or fish oil

Keywords: omega-3 fatty acids immune response