Kornimate/medical-research-clean huggingface dataset:
mitigating post-op rv dysfunction after lvad implantation

Conditions: Heart Failure; Right Ventricular Dysfunction; Right Ventricular Failure

Summary: this project evaluates right ventricle (rv) protective strategies after left ventricular assist device (lvad) implantation.

the main purpose of this study is to learn more about protecting against rv dysfunction and rv failure (rvf) in patients receiving lvad implantations. this is a prospective, randomized controlled study that will include 20 patients with heart failure undergoing lvad implantation. patients will receive their lvad implantation as part of routine care. patients will be randomized 1:1 to one of two arms, 1) standardized rv management arm, and 2) usual care rv management arm, which are both consistent with standard of care (soc).

Eligibility criteria:
inclusion criteria: * age ≥ 18 years * undergoing durable lvad implantation without plan for perioperative right ventricular mechanical circulatory support exclusion criteria: * patients with pre-operative right ventricular mechanical circulatory support or having high likelihood of requiring right ventricular mechanical circulatory support. * patients with rv implantable cardiac device (icd)/pacemaker lead who are pacemaker-dependent * pregnant patients

Keywords: lvad lvad-related complications right ventricular dysfunction hemocompatibility-related adverse events hemodynamic-related events post-operative right ventricular management right ventricular failure
an evaluation of marketed contact lens disinfectant systems on eyelid tissues

Conditions: Myopia

Summary: the purpose of this study was to assess and compare the effect of the repeated usage of 2 different care systems (one hydrogen peroxide based cleaning and disinfecting system and one phmb containing multipurpose system) with acuvue® 2® and air optix® aqua contact lenses worn on a daily wear basis for a 3-month period.

this study was divided into 2 periods, a screening phase and an investigational phase. during the screening phase, subjects were fitted and dispensed with either acuvue® 2® (for current hydrogel wearers) or air optix® aqua (for current silicone hydrogel wearers) contact lenses and used complete® mps easy rub® formula to clean and disinfect their lenses. at the completion of the screening phase, the symptomatic status of the subjects was re-assessed. those subjects who qualified proceeded to the investigational phase and were dispensed with new pair of study contact lenses identical to the lenses they wore during the screening phase to use in conjunction with the allocated study care product, clear care® /aosept® plus or renu multiplus®.

Eligibility criteria:
inclusion criteria: * read and understand the participant information sheet; * read, sign, and date an informed consent; * successfully wearing a frequent replacement hydrogel or silicone hydrogel contact lens brand under a frequent replacement (biweekly or monthly) daily wear modality; * classified as symptomatic according to protocol-specified criteria; * agree to wear study contact lenses as directed for the duration of the study; * best corrected visual acuity (bcva) of 6/9 or better in each eye; * other protocol-defined inclusion criteria may apply. exclusion criteria: * any known sensitivity or intolerance to any of the contact lenses or contact lens care products to be used; * monocular vision (only one eye with functional vision or only one eye fitted with contact lenses); * history of seasonal allergies, which may have an adverse impact on contact lens wear, or data and information obtained in this study; * systemic disease or use of medication which might interfere with contact lens wear or produce dry eye side effects; * ocular allergies or ocular disease which might interfere with contact lens wear or data and information obtained in this study; * active ocular infection; * use of any concomitant topical ocular medications during the study period; * significant ocular anomaly; * previous ocular surgery; * history of recent, significant changes in visual acuity; * any medical condition that might be prejudicial to the study; * pregnant, planning to be become pregnant, or lactating at time of enrollment; * any infectious disease (e.g. hepatitis, tuberculosis), immunosuppressive disease (e.g. hiv), or diabetes; * participation in an investigational drug or device study within 30 days of entering study; * other protocol-defined exclusion criteria may apply.

Keywords: clear care® aosept® plus renu multiplus® silicone hydrogel hydrogel acuvue® 2® air optix® aqua eyelid response wettability contamination contact lenses
cardiac interventional ice imaging trial

Conditions: Structural Heart Diseases; Atrial Septal Defect; Patent Foramen Ovale; Arrhythmias, Cardiac; Atrial Fibrillation; Supraventricular Tachycardia; Valve Disease, Heart

Summary: the intelice trial is a prospective, multicenter, 1:1 randomized controlled non-inferiority study. it aims to compare a novel intracardiac echography (ice) catheter and combined ultrasound system with existing commercial ones. the evaluation will be conducted on patients undergoing planned intracardiac interventional process.

this randomized controlled trial will enroll adult patients undergoing cardiac interventions, who will be randomly assigned to either the experimental device group or the control group. the main endpoint of the intelice trial is the image quality rate of intracardiac echocardiography, which will be evaluated by three experienced sonographers from the core laboratory, while the operator's image quality assessment serves as a secondary endpoint. in addition, secondary endpoints include clinical success rate, technical success rate, procedure time, and evaluation for the experimental devices.

Eligibility criteria:
inclusion criteria: * age ≥ 18 years, ≤90 years, of any gender. * subjects deemed suitable for the utilization of ice catheters during cardiac interventional procedures, as determined by investigators: 1. requirement for ice imaging of the heart; 2. requirement for ice imaging of great vessels; 3. requirement for ice imaging of other intracardiac devices. * subjects themselves or their guardians must possess the ability to comprehend the purpose of this study, demonstrate adequate compliance with the protocol, and sign the informed consent form. exclusion criteria: * anticipated vascular access (e.g., femoral vein, inferior vena cava, subclavian vein, internal jugular vein) cannot meet the procedure needs. * plt \ 1.5. * intracardiac blood clots or severe peripheral vascular disease (e.g., deep vein thrombosis, aneurysm, atherosclerosis). * sepsis, pyemia, or severe systemic infection. * nyha class iv. * history of cardiac or related cardiac areas surgery within 6 months. * inability to tolerate post procedure oral anticoagulants or antiplatelet drugs. * inability to tolerate or cooperate with the procedure. * pregnant or lactating women, women with a positive pregnancy test result within 7 days before enrollment. * participation in other clinical trials of drugs, biological agents or devices within 3 months before screening. * other exclusive circumstances determined by the investigators, where the subject is deemed unsuitable for enrollment.

Keywords: intracardiac echocardiography
development of a comprehensive ap training curriculum for adults

Conditions: Diabetes Mellitus, Type 1

Summary: an e-learning training program is to prepare people with diabetes and their physicians on the use of uva's artificial pancreas prototype -- diabetes assistant (dias).

this project will develop and test a comprehensive, web based training system for the artificial pancreas (ap) prototype identified as edapt (electronic diabetes artificial pancreas training). this e-learning training program is to prepare people with diabetes and their physicians on the use of uva's artificial pancreas prototype -- diabetes assistant (dias), a software platform for the development and outpatient testing of smart phone based systems for closed loop control of diabetes. the e-learning training program will be used in adjunct to in-person training with study staff at the onset of a clinical trial. it will be especially important as the number of clinical sites that use dias continue to grow both in the united states and internationally. it is also a critical step in moving the dias closer to a commercial product. a validated training program is required to proceed with the food and drug administration (fda) for both pivotal clinical trials and commercial approval of the ap.

Eligibility criteria:
diabetes clinicians inclusion criteria: * endocrinologist, certified diabetes educator, nurse practitioner actively managing patients with type 1 diabetes on insulin pumps and continuous glucose monitoring therapy * actively managing patients using insulin pumps for at least one year former \& novice study subjects inclusion criteria: * have type 1 diabetes mellitus as defined by american diabetes association criteria or judgment of physician for at least 1 year * no previous experience with the artificial pancreas system in a clinical trial * currently using insulin pump to manage their type 1 diabetes for at least one year * actively using an insulin pump with bolus calculator feature including predefined parameters for carbohydrate ratio, insulin sensitivity factor, target bg and active insulin * knowledge of continuous glucose monitors former study subjects inclusion criteria: • previous experience with the artificial pancreas system in a clinical trial

Keywords: diabetes assistant (dias) continuous glucose monitor (cgm) insulin pump human factors focus group artificial pancreas (ap) edapt (electronic diabetes artificial pancreas training)
the effectiveness of sunnah on sleeping on sleep quality, fatigue, depression and anxiety among patient undegroing hemodialysis

Conditions: Sleep Quality; Fatigue; Anxiety; Depression

Summary: this study to examine the effects of implementation sunnah on sleeping on sleep quality, sleep time receiving a slow stroke back massage on fatigue and quality of life among participants undergoing maintenance hemodialysis will be applied. the study will be conducted at the hemodialysis unit of a medical center in a central part of indonesia. to determine the sample size at a 95% confidence level and 80% test power, with a mean difference of at least 0.72 and a standard deviation of 1.22 in the intervention group and 1.22 in the control group, based on the study of \[17\] and according to the sample size formula, we determined a requirement of 205participants in each group. forty participants were recruited and allocated to either the experimental group (n=25) or the control group (n = 25). participants will be recruited if they were: (i) 18 years of age or over; (ii) under- going hemodialysis for a minimum of three months; (iii) undergoing maintenance hemodialysis; (iv) diagnosed with a maximum of two comorbidities; (v) affiliated to islam; and (vi) not hearing-impaired. participants were excluded if they had, (i) muscle problems, and (3) unstable vital signs. a thorough review of participant charts will be performed to confirm they met the inclusion and exclusion criteria. participants then will be randomly assigned to two different groups based on their hemodialysis schedule. the measurement of demographic and illness-related characteristics; the functional assessment of chronic illness therapy-fatigue (facit-fatigue) and pitssburg sleep quality index (psqi) will be conducted at the baseline and after the fourth week. the facit-fatigue scale was used to measure participant fatigue. facit-fatigue has 13 items to assess fatigue and its impact on functioning and daily activities in a number of chronic diseases, with five-point response options from 0 to 4. the total score ranges from 0 to 52, where a higher total score reflects less fatigue. the items include tiredness, listlessness, weakness, lack of energy, and impact on daily. in the study, we will use a validated indonesian version of facit-fatigue. this version has been tested on 52 participants by sihombing et al 2016 with ckd and has good internal reliability with a cronbach's alpha of 0.62 (20). the psqi has been translated and tested for validity and reliability by setyowati \& chung (2021). the cronbach alpha for indonesian version of psqi is 0.72 which means that the indonesian version of psqi has adequate reliability (21).


Eligibility criteria:
inclusion criteria: participants undergoing hemodialysis were recruited if they were: (1) 18 years of age or over; (2) undergoing maintenance hemodialysis twice a week for a minimum of three months; (3) affiliated to islam, and (4) not hearing-impaired exclusion criteria: * participants were excluded if they had unstable vital signs.
predictive value of heart rate variability on cardiorespiratory events

Conditions: Post-immunisation Apnoea and Bradycardia of Prematurity (AOP)

Summary: the aim of this study are to investigate whether heart rate variability (hrv) parameters derived from nonlinear time series analysis at five different time points have prognostic utility for assessing the risk of postimmunisation aop in very preterm/very low birth weight infants immunised in the hospital.


Eligibility criteria:
inclusion criteria for preterm infants: * gestational age (ga) 22+0 to 31+6 weeks and/or birth weight 400 g to 1500 g * chronological age \> 7 days * written informed parental consent inclusion criteria for term healthy control infants: * ga 37 to 42 weeks, chronological age 3 to 28 days (beyond initial transition after birth) * hospitalised in the neonatal rooming-in unit of the university children's hospital basel as healthy co-twin or healthy sibling, or neonate ready to be discharged home after reconvalescence from minor illness such as hyperbilirubinaemia * written informed parental consent exclusion criteria: * major congenital malformations including neuromuscular disorders, thoracic malformations, major cardiac malformation * lack of written informed parental consent
real-life experience of the use of isomers as metpure xl (s (-) metoprolol succinate) for evaluation of efficacy, safety and tolerability in the management of cardiovascular disease in colombian patients

Conditions: Hypertension; Coronary Disease

Summary: this is a phase 4, observational, open study in patients who their doctor has prescribe metpure xl (s (-)metoprolol succinate)by clinical practice. no medication was provided by the sponsor. the planned observation time is 8 weeks. the 8 weeks of observation involves an evaluation of baseline followed by information gathered from the assessment visits at week 4 and week 8.


Eligibility criteria:
inclusion criteria: * patients who were prescibed with s(-)metoprolol succinate(25mg, 50mg), depending on their clinical condition and use locally approved will be eligible to participate in this study

Keywords: observational colombia metpure xl
efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in hr+/ her2- early breast cancer

Conditions: Early Breast Cancer

Summary: the investigator conduct a phase ii multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, her2-negative early breast cancer.


Eligibility criteria:
inclusion criteria: * patient is ≥ 18 years-old * patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause) * patient with histologically confirmed hr+/her2- early breast cancer (immunohistochemical er and/or pr≥10%) * histologically confirmed invasive breast cancer with anatomic stages of iia-iiic stage (t2-4n0-3m0), of which stage iia only included t1n1m0 * patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion * from operation to enrollment should not exceed 12 months * patient has an eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * metastatic disease (stage iv) or inflammatory breast cancer * previous or current history of malignant neoplasms, except for curatively treated:basal and squamous cell carcinoma of the skin,carcinoma in situ of the cervix. * clinically relevant cardiovascular disease:known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110); * a history of allergy to the drugs in this study； * unable or unwilling to swallow tablets * history of gastrointestinal disease with diarrhea as the major symptom.
developing and implementing familial hypercholesterolemia registry

Conditions: Familial Hypercholesterolemia

Summary: familial hypercholesterolemia (fh) is a most prevalent genetic disorder define as high cholesterol level and premature death. the prevalence of fh reported in few countries however unknown in iran. thus determine the fh patient, finding diagnostic strategy and appropriate treatment are important. we intent to use cascade method to screening patients, also our expected outputs are to develop and implement a registry program for fh patients and their families and to study their genetic disorder. fh patients will be followed from management, treatment and prevention of cardio vascular disease in order to increase premature death.

familial hypercholesterolemia (fh) is a genetic disorder define as high cholesterol levels, particularly very high levels of low-density lipoprotein (ldl), in the blood and early cardiovascular disease and premature death. fh is an autosomal dominant disease with a prevalence 1:500 (new study in netherlands demonstrated 1:244) in population more frequent than cystic fibrosis, mellitus diabetes or neonatal hypothyroidism. canadian registry demonstrated fh is more common among people if french canadian, christian lebanese, and afrikaner descent. the major causes of fh are pathogenic variant in the ldl-receptor (ldlr) gene or the apo lipoprotein b (apob) gene. the clinical signs of fh are high level of cholesterol (between 350-550 mg/dl in heterozygous), yellow deposits of cholesterol-rich fat in various places on the body such as around the eyelids (known as xanthelasma palpebrarum), the outer margin of the iris (known as arcus senilis corneae), and in the tendons of the hands, elbows, knees and feet, particularly the achilles tendon (known as a tendon xanthoma). fh is a hidden syndrome which leads to cardiovascular disease. after introducing the statins total mortality have reduced significantly in these patients. thus screening and identification of patients and treatment with the most effective therapies will decrease the risk of premature death. also, most of patients require an appropriate lipid-lowering medications. although the genetic problem is the most important factor to expression of fh other factors like environmental and metabolic factor can be effective in cvd and premature death. therefore, identification and follow-up fh patients is important for cvd rate cuts and decrease treatment costs thus this study can gain these outcomes.

Eligibility criteria:
inclusion criteria: personal concentration of ldl-c \> 190 mg/dl or ldl-c \> 120 mg/dl in treatment group. family and/or personal history of premature heart disease. exclusion criteria: hyperlipidemia with underlying disorders.
smartphone application for initiation of protective ventilation. clinical impact of instrumental dead space reduction

Conditions: ARDS, Human; Mechanical Ventilation Complication; Humidifier Lung

Summary: clinical evaluation of a new educative tools (smartphone application) based on impact of instrumental dead space reduction after initiation of protective ventilation during mechanical ventilation.


Eligibility criteria:
inclusion criteria: * age \> 18 years old * mechanical ventilation (control,assist control or simv mode) * haemodynamic stability (vasopressor \< 0.2 ug/kg/min) * no prone position schedule in the next 2 hours following procedure inclusion * presence of an arterial catheter exclusion criteria: * ecmo or anticipate ecmo * body temperature \< 36.0 for post operative patient (cardiac surgery)
antimullerian hormone as an indicator for ovarian response

Conditions: Infertility, Female

Summary: anti mullerian hormone (amh) is gaining place as ovarian marker, chiefly in infertility assistance. investigators explored its correlation with oocytes retrieval after long gnrh agonist protocol for stimulation, in younger and older infertile population. methods: this prospective analysis compiled data of 66 females, receiving icsi treatment from april 2016 to october 2017. serum fsh, lh, estadiol, amh and antral follicle count were assessed. outcomes were measured as good (5 to 19 oocytes) and bad responders.


Eligibility criteria:
inclusion criteria: 1. age:20-40 years old 2. bmi:20-40kg/m 3. normal baseline hormonal profile (on the 2nd day of the cycle) * fsh: 2.5-10.2mlu/ml * lh:1.9-12.5mlu/ml * estradiol (e2): \<50pg/ml 4. no endometriosis by laparoscopy 5. no prior ovarian surgery; overectomy, ovariectomy or oophrectomy 6. female subjects who have at least 1 wash-out cycle (defined as greater than or equal to 30 days since the last dose of clomiphene citrate or gonadotrophin treatment) since the last art cycle and/or clomiphene citrate or gonadotrophin treatment prior to starting gonadotrophin releasing hormone (gnrh) agonist therapy exclusion criteria: * 1. age: \ 40 years old 2. bmi: \ 40kg/m 3. female subjects with any contraindication for pregnancy. 4. female subjects with history of tumors of the hypothalamus \& pituitary gland. 5. female subjects with history of ovarian, uterine or mammary cancer. 6. female subjects with history of hypersensitivity to the active substance of the medications used for ovarian stimulation. 7. abnormal baseline hormonal profile 8. endometriosis by laparoscopy 9. previous ovarian surgery; overectomy, ovariectomy or oophrectomy 10. female subjects with abnormal gynecological bleeding of unknown etiology