Kornimate/medical-research-clean huggingface dataset:
a study of enlicitide chloride (mk-0616) in healthy participants and participants taking statins (mk-0616-012)

Conditions: Healthy; Hypercholesterolemia

Summary: the goal of this study is to learn what happens to different doses of enlicitide chloride over time in the body of healthy participants and participants taking statins, a group of medicines used to reduce the levels of high cholesterol in the bloodstream. the researchers want to learn about the safety of enlicitide chloride when administered at high doses.


Eligibility criteria:
inclusion criteria: the key inclusion criteria include but are not limited to the following: * is in good health based on medical history, physical examination, vital signs (vs) measurements, electrocardiograms (ecgs), and laboratory safety tests performed before randomization * has a body mass index (bmi)≥18 and ≤32 kg/m\^2 exclusion criteria: the key exclusion criteria include but are not limited to the following: * has a history of clinically significant endocrine, gastrointestinal (gi), cardiovascular, hematological, hepatic, immunological, renal, respiratory, genitourinary, or major (including stroke and chronic seizures) abnormalities or diseases * has a history of cancer
impact of umbilical cord milking in preterm neonates with placental insufficiency

Conditions: Placental Insufficiency; Preterm Infant

Summary: to investigate the effect of umbilical cord milking (ucm) on peripheral hematologic parameters including hematopoietic progenitor cells in premature infants ≤ 34 weeks gestational age with placental insufficiency. we hypothesize that ucm would enhance peripheral cd34 concentration, hemoglobin and reduce prematurity complications like nec and ivh in preterm infant ≤ 34 week gestational age with placental insufficiency.

a pilot prospective randomized controlled study will be conducted among 3 groups, all of them are preterm less than 34 weeks gestational age, in the first group umbilical cord milking will be done for preterm infant with placental insufficiency. two control groups are present, in the first one umbilical cord milking will be done for preterm infants without placental insufficiency (insufficiency vs. no insufficiency), another group of immediate cord clamping for preterm infants with placental insufficiency will be added (milking vs. no milking), 30 cases will be recruited in each group. umbilical cord milking (ucm) is typically performed by placing the infant below the level of the placenta. the cord is held at 20-25 cm distance from the baby and milked vigorously towards the umbilicus for 3 times at a speed of 10 cm/sec. after completion, the cord is clamped, and the neonate is handed to the resuscitation team. one milliliter of fetal blood will be taken from peripheral venous blood in the first 30 min of life and cd34 will be assessed by flow cytometry. secondary outcomes will be documented during nicu stay that include admission cbc, peak bilirubin concentrations, cbc after 2 months, neonatal morbidity such as sepsis, bronchopulmonary dysplasia, necrotizing enterocolitis, retinopathy of prematurity and polycythemia, therapeutic interventions such as need for inotropes, nasal cpap, mechanical ventilation and phototherapy.

Eligibility criteria:
inclusion criteria: * preterm neonates \< 34 weeks gestational age exclusion criteria: * vaginal bleeding due to placental abruption or tears * multiple pregnancies * suspected major fetal anomalies * suspected chromosomal aberration * maternal drug abuse * hydrops fetalis * preterm who needed major resuscitative measures

Keywords: umbilical cord milking
efficacy and safety of lucentis® (ranibizumab intravitreal injections) in chilean patients with diabetic macular edema.

Conditions: Retinal Vein Occlusion; Age Related Macular Degeneration

Summary: ranibizumab is a humanized anti-vascular endothelial growth factor (vegf) monoclonal antibody fragment approved in chile by the instituto de salud pública for the treatment of diabetic macular edema (dme), retinal vein occlusion and age-related macular degeneration. currently, there is limited epidemiologic information in chile regarding the incidence of dme and limited experience of anti-vegf hospital therapy. this study will evaluate the efficacy of intravitreal ranibizumab in chilean dme patients, to investigate the anatomical and functional improvement following this treatment and to increase the local experience regarding the use of anti-vegf in the treatment of diabetic macular edema.


Eligibility criteria:
inclusion criteria: 1. diagnosis of macular edema due to diabetes (confirmed by fundus photography, and/or fluorescein angiography, and/or oct) in at least one eye. 2. vision impairment due to dme (bcva etdrs letter score at 4 meters between 20 and 70 letters (6/12 - 3/60 at snellen chart). exclusion criteria: 1. laser photocoagulation in the study eye for the last 3 months. 2. any history of any intraocular surgery in the study eye within the past 3 months. 3. blood pressure \>160/100 mmhg. 4. proliferative diabetic retinopathy. any other protocol inclusion/exclusion criteria that may apply.
therapeutic efficiency of mandibular advancement device using smartphone sleep applications and pulse oximeter

Conditions: Obstructive Sleep Apnea

Summary: an observational clinical trial in a single centre. the objective of this study was to determine the efficacy of mandibular advancement device (mad) therapy on snoring intensity, frequency, and oxygen desaturation periods in mild-moderate obstructive sleep apnea (osa) patients with snoring problems. totally, 18 mild-moderate osa patients (8 females and 10 males) with subjective snoring complaint were selected. each patient's diagnostic polysomnographic analysis (psg) was accepted as initial psg values. each patient was subjected simple pulse oximeter (spo) and smartphone sleep application (ssa) at 3 different nights at home. diagnostic mean values of oxygen desaturation index (obtained by using spo), snoring intensity score (obtained by using ssa), and snoring percentage (obtained by using ssa) were recorded. non-titratable-customized mad with 60-75% of maximal mandibular protrusion were fabricated. the patients were instructed to wear their mad every night. spo and ssa measurement were repeated at the 1st, 4th, 12th, and 24th week of the treatment process. at the 24th week of treatment, the psg were repeated and all psg, spo, and ssa values were compared with initial diagnostic values.


Eligibility criteria:
inclusion criteria: * mild-moderate osa patients with subjective snoring complaints exclusion criteria: * severe osa * undergone previous surgical therapy for ss or osa * high-risk of cardiovascular, respiratory, neurological, or psychiatric disorders * inadequate dental anchor for mad treatment * temporomandibular joint dysfunction * angle class iii maxillomandibular relation

Keywords: snoring obstructive sleep apnea mandibular advancement device pulse oximeter device smartphone sleep applications
treatment of chronic pelvic pain due to endometriosis by transcutaneous auricular vagus nerve stimulation

Conditions: Endometriosis

Summary: 6-10% of women of childbearing age suffer from endometriosis, which is mainly manifested by dysmenorrhea, non-menstrual pelvic pain and dyspareunia. several treatment strategies, including surgical ones, are proposed but they are sometimes insufficient because endometriosis-related pain is frequently accompanied by sensitization. endometriosis surgery, when indicated, is therefore changeably effective, even though the lesions have been completely resected. patients therefore consult pain units seeking for the effective treatment as the pain persist even after surgical management of endometriosis. vagus nerve stimulation is a non-invasive technique that includes an anti-inflammatory effect and a modulation of neurotransmitter production (adrenaline, norepinephrine; serotonin, acetylcholine). yuan and silberstein published a general review on the technique. migraine and depression are one of the selected indications. in addition, napadow et al. published favourable results in a short series of patients with chronic pelvic pain. the investigators of this study have treated some patients with this technique with a result deemed satisfactory which leads to propose a randomized study to confirm this impression.


Eligibility criteria:
inclusion criteria: * women aged \>= 15 years * with chronic pelvic pain and/ or dysmenorrhoea and/ or dyspareunia * who has been cared for by a gynecologist in one of the institutions participating in the study * diagnosed with endometriosis * having signed an informed written consent * affiliated to a health insurance scheme exclusion criteria: * contraindication to the use of transcutaneous auricular vagus nerve stimulation (cardiac pathology, asthmatic patient) * pregnant or breastfeeding women * patient undergoing in vitro fertilization * associated pathology requiring long-term analgesic treatment * patient with atria trans vagal neurostimulation in the 12 months prior to inclusion * patient deprived of liberty or under guardianship

Keywords: chronic pelvic pain transcutaneous auricular vagus nerve stimulation
uric acid and long-term outcomes in chronic kidney disease

Conditions: Chronic Kidney Disease

Summary: patients in the earlier stages of chronic kidney disease (ckd) are at risk both for the development of end-stage renal disease (esrd) (define by the requirement for dialysis or kidney transplantation) and development of cardiovascular disease (cvd). although controversial, there is literature to suggest that uric acid may play a role in the progression of kidney disease and development of cardiovascular disease (cvd). the modification of diet in renal disease (mdrd) study was a randomized controlled trial in patients with ckd, which examined the effects of dietary protein restriction and strict blood pressure control on progression of non-diabetic ckd. extensive data on risk factors for progression of kidney disease and development of cvd are available, as is long term follow up. 838 of the 840 patients who were randomized have uric acid levels measured at baseline. the aims of the present study are to examine the determinants of uric acid in cross sectional analysis at baseline, to determine the association between uric acid and development of esrd, and the association of uric acid with all-cause and cvd mortality. level of kidney function will be a major determinant of uric acid levels independent of other risk factors. level of uric acid will be associated with development of esrd independent of level of kidney function and other risk factors. uric acid levels will be associated with both all-cause and cvd mortality independent of kidney function and other risk factors.


Eligibility criteria:
inclusion criteria: * between 18 and 70 years of age * with serum creatinine of 1.2 to 7 mg/dl in women and 1.4 to 7 mg/dl in men exclusion criteria: * pregnancy * type i diabetes * insulin dependent type ii diabetes * renal artery stenosis * proteinuria greater than 10mg/day * mean arterial pressure greater than 125 mmhg * prior kidney transplant

Keywords: kidney disease uric acid outcomes cardiovascular mortality kidney failure uric acid levels in patients with chronic kidney disease
study of dtap-ipv-hep b-prp~t combined vaccine compared with pentaxim™ and engerix b® pediatrico in argentinean infants

Conditions: Diphtheria; Tetanus; Pertussis; Haemophilus Influenzae Type b; Poliomyelitis

Summary: primary objective: * to demonstrate that the immune response of the dtap-ipv-hep b-prp\~t is non-inferior for all valences to those of the association of pentaxim™ and engerix b® pediatrico one month after a three-dose primary series. secondary objectives: * to describe in each group the immunogenicity parameters one month after the three-dose primary series. * to describe safety profile after each vaccination in both groups.


Eligibility criteria:
inclusion criteria : * infant of either gender, aged 50 to 70 days inclusive * mother is negative for hbsag * born at full term of pregnancy (≥37 weeks) and with a birth weight ≥2.5 kg * written informed consent form signed by at least one parent or by another legal representative and an independent witness * parent/legal representative able to attend scheduled visits and to comply with the trial procedures during the entire duration of the trial. exclusion criteria : * axillary temperature ≥37.1°c on the day of inclusion * current or planned enrolment in another clinical trial during the clinical trial period * known mother's history of human immunodeficiency virus (hiv) infection * known immunodeficiency (congenital or acquired) or induced by immunosuppressive therapy such as anti-cancer chemotherapy or radiation therapy since birth, or systemic corticosteroids in the last 4 weeks (≥0.5 mg per kilogram and per day equivalent prednisolone and lasting more than 7 days) * receipt of blood-derived products since birth * acute symptoms or severe chronic illness (e.g. cardiac, renal insufficiency, diabetes, auto immune disorders, congenital defect) that may interfere with conduct or completion of trial * occurrence of seizures since birth * hypersensitivity to any of the vaccine components * coagulopathy contraindicating intramuscular injection * history of (documented) clinical or serological/microbiological confirmed infection due to pertussis, tetanus, diphtheria, polio, haemophilus influenzae type b (hib) or hepatitis b (hb) diseases * history of vaccination against pertussis, tetanus, diphtheria, polio, hib or hb infections * vaccination within the last 4 weeks.

Keywords: diphtheria tetanus pertussis whooping cough hepatitis b poliomyelitis haemophilus influenzae type b
azacytidine + hag regimen vs. azacytidine for elderly patients with newly diagnosed myeloid malignancy

Conditions: Acute Myeloid Leukaemia; Myelodysplastic Syndromes;Chronic Myelomonocytic Leukemia

Summary: the primary objective is to explore the efficacy and safety of azacytidine and hag regimen versus azacytidine for elderly patients with newly diagnosed mds/aml/cmml in china. this is a post-marketing, interventional, multi-center, double-arm, prospective, open-label, randomized controlled study in elderly patients with mds/aml/cmml in china. patients will be recruited consecutively from the study sites during the enrollment period. the enrolled patients will be given azacytidine + hag regimen or azacytidine under the conditions of informed consent and frequent monitoring according to the clinical guideline.


Eligibility criteria:
inclusion criteria: * age ≥ 60; * patients with newly diagnoised diseases including mds/aml/cmml; * the ecog behavior status score is less than 3 points; * agree to sign informed consent exclusion criteria: * patients with a history of sever heart disease; * patients with severe organ dysfunction; * patients with other malignancies * patients who are allergic to the treatment of drug ingredients

Keywords: azacytidine; hag regimen
role of fapi pet/mr combined with gadoxetate disodium in assessing hepatic malignancies

Conditions: Hepatic Malignancies

Summary: this study aimed to prospectively evaluate the utility of fibroblast activation protein inhibitor (fapi) positron emission tomography (pet)/magnetic resonance (mr) combined with gadoxetate disodium in patients with clinical suspected hepatic malignancies (lesion diameter ≤ 3.0cm), with histopathological findings obtained from biopsy or resected surgical specimens, or follow-up results as reference standards.

1. clinical and biological data, including the course of disease, underlying liver disease (hepatitis or cirrhosis), serum alpha-fetoprotein, carcinoembryonic antigen and carbohydrate antigen 19-9 levels were collected from each patient. 2. pet image analysis: each patient underwent both fapi and fluorodeoxyglucose (fdg) pet/mr, including t1-weighted imaging (t1wi), t2-weighted imaging (t2wi), diffusion-weighted imaging (dwi), apparent diffusion coefficient (adc) and gadoxetate disodium-enhanced mri. record and evaluate the following indicators: the maximum standardized uptake value (suvmax) of lesions, the target-to-background ratio (tbr) which was calculated by dividing the suvmax of the lesion by the background suvmean obtained from nontumor liver tissue. 3. pathological analysis: hematoxylin and eosin staining and immunohistochemical analyses will be performed. immunohistochemical analysis will be used to investigate the expression of glucose transporter-1 (glut-1) and fibroblast activation protein (fap).

Eligibility criteria:
inclusion criteria: 1. patient ≥ 18 years of age at the time of consent; 2. patients with suspected, newly diagnosed, or previously treated liver cancer; 3. estimated creatinine clearance \> 30ml/min; 4. provided written informed consent authorisation before participating in the study. exclusion criteria: 1. allergic to the gadoxetate disodium； 2. mri contraindications, not limited to cardiac implantable electronic devices and claustrophobia; 3. weight \> 90kg; 4. pregnancy or lactation; 5. active inflammation may affect fapi imaging.

Keywords: hepatic malignancies fapi pet/mr gadoxetate disodium fdg
behavioral economics and mobility after stroke (be mobile)

Conditions: Stroke

Summary: in this pilot, randomized controlled trial, the investigators will compare the preliminary effectiveness of a gamification with social incentives 8 week intervention to increase physical activity for adults with stroke.

in this 2 arm randomized trial, the investigators will compare the preliminary effectiveness of a social incentive-based gamification intervention to increase physical activity relative to a control arm among adults with stroke. all participants will use a fitbit wearable device to establish a baseline step count, select a step goal increase of 33% to 50% above their baseline and then participate in an 8 week intervention. the gamification arm will be entered into a game with points and levels designed using insights from behavioral economics. they will be asked to select a social support partner who will receive weekly updates on their progress in the game.

Eligibility criteria:
inclusion criteria: * history of ischemic or hemorrhagic stroke (confirmed with icd-10 or drg code) at least 3 months prior to enrollment * ability to provide informed consent * life space assessment mobility level 3 * ability to ambulate outside of their home (self-reported) * owns a smartphone or tablet compatible with required applications for the wearable tracking device * sufficient cognitive ability to participate (5-minute montreal cognitive assessment score ≥ 11 points) exclusion criteria: * inability to provide informed consent, illiteracy or inability to speak, read, and write english * self-reported history of falls within the last 3 months * severe cognitive impairment (moca score ≤ 10 points) * medical condition that may limit participation in physical activity program (e.g. metastatic cancer, end-stage renal disease) * currently institutionalized in skilled nursing or long-term care facility * baseline step count \> 7500/day * currently receiving physical therapy services

Keywords: physical activity wearable gamification
impact of steerable delivery sheaths on successful closure of la a with amulet

Conditions: Atrial Fibrillation; Stroke

Summary: the novel amplatzer steerable delivery sheath (abbott vascular) is found to be safe and effective in performing laao procedure. however, the procedural outcomes have not been compared with the traditional non-steerable fixed curve sheath. in this study investigators aim to compare the outcome of patients undergoing left atrial appendage occlusion with the dual mechanism closure amulet device using non-steerable fixed curve sheath versus a novel steerable sheath.

atrial fibrillation (af) is the most common abnormal heart rhythm associated with substantial morbidity and mortality. it is one of the strongest risk factors of systemic thromboembolism (te), with stroke being the most serious outcome. prevention of stroke is the cornerstone of managing af, which can be achieved either by oral anticoagulation (oac) or percutaneous left atrial appendage occlusion (laao) in patients who have a contraindication to oac. heterogeneity in cardiac chamber size, interatrial septum, laa anatomy and orientation, operator experience and currently available fixed curve sheaths add to the complexity of the procedure. alignment of laao device along the access of the left atrial appendage body is an important factor in improving closure rates. the devices which are currently approved by fda for laa closure in the u.s. are amplatzer amulet device (abbott medical) and watchman and watchman flx devices (boston scientific). in a recent study, amplatzer amulet device was found to be noninferior in terms of safety and effectiveness, with superior laa occlusion rates but higher device-related complications as compared to first generation watchman device. the laao device sheaths that are used currently have fixed shapes and angles that may not be optimal for some laa anatomy, which can lead to excessive device manipulation, prolonged procedure time, and potentially suboptimal co-axiality during the process. this may lead to increase device related complications. the new amplatzer steerable delivery sheath (abbott vascular) is designed to provide distal bidirectional steerability of the sheath for amulet implantation. such steerability may enable successful endovascular closure of greater proportion of laa, allow precise position of the transseptal puncture, and potentially reduce procedural times and complications with complex cases. investigators hypothesize that the use of novel steerable sheath for laao closure is safer and more effective as compared to non-steerable fixed curve sheath

Eligibility criteria:
inclusion criteria: patients with atrial fibrillation who meets the indication/criteria for left atrial appendage occlusion and undergoing implantation of amplatzer™ amulet™ left atrial appendage occluder device exclusion criteria: * patient been/being implanted with device other than amplatzer™ amulet™ left atrial appendage occluder * pregnant or breastfeeding patients * prisoners * patients not willing to participate in the study