Kornimate/medical-research-clean huggingface dataset:
mocravimod as adjunctive and maintenance treatment in aml patients undergoing allo-hct

Conditions: Adult Acute Myeloid Leukemia

Summary: this is a multi-center, randomized, double-blinded, placebo controlled trial.

the purpose of this study is to evaluate the efficacy and safety of mocravimod as an adjunctive and maintenance treatment in adult acute myeloid leukemia (aml) patients undergoing allogeneic hematopoietic cell transplantation (hct).

Eligibility criteria:
inclusion criteria: * diagnosis of aml (excluding acute promyelocytic leukemia) according to the who 2022 classification of aml and related precursor neoplasm, including aml with myelodysplasia-related gene mutations * european leukemia net (eln) high-risk or intermediate-risk aml in cr1, or aml of any risk in cr2, \[cri\] is also allowable * planned allogeneic hct from fully matched related or unrelated donor with no more than 1 antigen mismatch or planned use of haploidentical donor using pbsc graft * any conditioning regimen with a transplant conditioning score (tci) ≥ 1.5 * planned use of tac-based gvhd prophylaxis * age ≥ 18 years and ≤ 75 years * eastern cooperative oncology group (ecog) performance status of 0 or 1 exclusion criteria: * use of csa, anti-thymocyte globulin (atg), alemtuzumab, abatacept for gvhd prophylaxis * diagnosis of macular edema during screening * cardiac/pulmonary/hepatic/renal dysfunction * hepatic dysfunction as defined by aspartate aminotransferase (ast) and/or alanine aminotransferase (alt) \> 2.5 x upper limit of normal (uln); or total bilirubin \> 1.5 mg/dl * renal dysfunction with estimated creatinine clearance \< 45 ml/min by the cockcroft-gault formula * diabetes mellitus * history or presence of uveitis at screening * history or diagnosis of macular edema
optimal duration of voice rest after surgery for benign vocal lesions

Conditions: Vocal Fold Polyp; Vocal Cord Cyst; Vocal Nodules in Adults

Summary: aim of study: to determine the optimal duration of voice rest following phonosurgery for patients who undergo phonosurgery due to benign vocal cord lesions ie: vocal fold nodules, cysts, polyps, granulomas, leukoplakia, and subepithelial edema.

optimal duration of voice rest voice following phonosurgery for benign vocal lesions: prospective randomized study background: phonosurgery is performed in order to improve voice quality in patients with various vocal fold pathologies including nodules, cysts, polyps, granulomas, leukoplakia, and subepithelial edema. it is customary to order the patients voice rest following vocal fold surgery, however, according to the current literature, it is not well known how long patients should remain in voice rest following phonosurgery (regardless of the type of benign lesion) in order to achieve the best voice quality results. in the literature, there is one preliminary study that shows that when voice quality was assessed at 15 days post-surgery, patients with voice rest of 10 days had better voice outcomes compared to patients with 5 days voice rest(1). a contradicting study, that measured voice outcomes in patients at 1, 3, and 6 months post-operatively, shows that a short voice rest of 3 days lead to better voice results compared to a 7 days voice rest(2). the aim of our study is to determine the optimal duration (3 versus 7 days) of voice rest following phonosurgery for patients who undergo phonosurgery due to benign vocal cord lesions in order to achieve better voice quality post-operatively. in this study, patients will be randomly assigned into one of 2 different groups of voice rest durations: either 3 or 7 days following surgery. patients will undergo pre and post (at 1, 3 and 6 months) operative voice testing. voice quality testing will include: perceptual voice analysis using the grabs (grade, roughness, asthenia, breathiness, and strain) scale, voice handicap index-10 (vhi) questionnaire, measurement of maximum phonation time (mpt), and computerized voice analysis including voice intensity, fundamental frequency (f0), jitter, shimmer, and dysphonia severity index (dsi).

Eligibility criteria:
inclusion criteria: * • patients who undergo phonosurgery for benign vocal fold lesions. * adults (18-90years). * patients who can provide and give informed consent. exclusion criteria: * • patients without a complete medical record * patients who are unable or unwilling to give informed consent * patients younger than 18 years of age or older then 90 years * patients who are pregnant
open vs. endoscopic transversus abdominis release trial

Conditions: Incisional Hernia of Midline of Abdomen

Summary: this study aims to comparatively evaluate the early and long-term results of open and endoscopic tar procedure for large midline incisional ventral hernias.

minimally invasive (endoscopic) transversus abdominis release (tar) - new technique for the treatment of patients with large incisional ventral hernia. term "endoscopic" tar combines two minimally invasive (laparosopic or extraperitoneal (etep) approaches. these techniques have demonstrated significant advantages compared with open tar in several retrospective studies. there are currently no randomized trials comparing open and endoscopic tar operations for incisional ventral hernia repair.this study aims to comparatively evaluate the early and long-term results of open and endoscopic tar procedure for large midline incisional ventral hernias. the sample size was determined based on a previously conducted retrospective pilot study comparing the results of open and endoscopic tar procedures for midline incisional ventral hernia repair. the retrospective study included 133 patients with midline incisional ventral hernias who were underwent rives-stoppa hernia repair in combination with bilateral posterior component separation with transversus abdominis release via open (open tar) or endoscopic (etar) technique in moscow city hospital №1 from january 2018 to december 2022. all patients were included in the study, starting from the moment of endoscopic tar technique was introduced into the clinic. at the same time, the learning curve for the open tar had already been reached at that time; more than 20 open tar interventions were performed in the clinic in 2016-2017. the average hospitalization time in open tar group was 6.7 ± 2.14 days. in endoscopic tar group the average hospitalization time after surgery was 5.2 ± 1.65 bed days. after achieving the learning curve (20 operations) for the endoscopic tar procedure technique average hospitalization period after surgery was 4.8 ± 1.47 days. thus, a decrease in the duration of hospitalization in endoscopic tar group after reaching the learning curve was noted by 28.4%. this fact, based on a retrospective pilot study, allows the investigators to assume as a hypothesis for this rct a reduction in the duration of hospitalization during endoscopic tar by at least 30% as a guideline for calculating the power of the study. thus, assuming a type i error probability α of 0.05 and a type 2 error probability β of 0.20, it would require a total sample size of 36 patients (18 patients in each group).

Eligibility criteria:
inclusion criteria: * midline incisional hernia * defect width from 8 till 12 cm * asa i-iii class * able to give informed consent * elective hernia repair * considered eligible for minimally invasive ventral hernia repair exclusion criteria: * primary ventral hernia * lateral hernia with/without midline * refuse to give informed consent

Keywords: incisional hernia etep open tar endoscopic tar transversus abdominis release
effect of laparoscopic sleeve gastrectomy on vitamin d, parathormone and calcium levels

Conditions: Bariatric Surgery Candidate; Obesity, Morbid; Vitamin D Deficiency; Calcium Deficiency

Summary: obesity is likely to be the disease of the 21th century. the growth of obesity is worldwide, a pandemic, and has increased globally in the last 30 years. developed countries were more affected, but developing countries have increasingly contributed to this epidemic as they continue to modernize. the national and global burden of obesity, with its public health and financial implications, is projected to increase markedly in the next two decades. the study aimed to assess the effect of vit d supplementation on preventing altered levels of calcium, vit d, and parathormone after laparoscopic sleeve gastrectomy.


Eligibility criteria:
inclusion criteria: * adult * male or female * from 18 to 60 ages * bmi: 40 kg/m2 or \> 35 kg/m2 * comorbidities e.g., hypertension and dm * conservative management for obesity failed in at least 2 years exclusion criteria: * bmi \> 60 * history of bariatric surgery * symptomatic reflux oesophagitis * stomach cancer * active peptic ulcer disease * alcohol or drug abuse * major psychological disturbance * major eating troubles * risky anesthesia * risky surgery.
spp100 (aliskiren) regimen in hypertensive patients with renal dysfunction

Conditions: Hypertension

Summary: assessing the safety, efficacy and pharmacokinetics of spp100 (aliskiren) regimen in hypertensive patients with renal dysfunction


Eligibility criteria:
inclusion criteria: * age: 20 - 80 years old * gender: male or female * status: outpatients * elevated serum creatinine exclusion criteria: * patients suspected of malignant hypertension * patients with a clinically significant allergy * patients who have received other investigational drug other protocol-defined inclusion/exclusion criteria may apply

Keywords: hypertension, aliskiren, blood pressure, rennin
multifocal electroretinogram in normal egyptian population

Conditions: Retinal Disease; Healthy Population

Summary: studying normal subjects to create unique normal database for multifocal electroretinogram (mf-erg) in specific population.

normal parameters for electroretinogram (erg) is important in studying specific population, studying normal subjects is important to create specific normal database for each population. this will help in accurate differentiation for various ocular diseases and in research trials.

Eligibility criteria:
inclusion criteria: * normal subjects seeking regular ophthalmic check-up at banha university hospital. exclusion criteria: * any retinal diseases that may affects mf-erg waves. * subjects with best corrected visual acuity less than 0.7 in decimal form at time of examination. * refractive errors more than 0.5 diopter as measured by autorefractometer.

Keywords: normal electroretinogram delta population
metabolic effects of medium-chain fatty acids in patients with medium-chain acyl-coa dehydrogenase deficiency and healthy individuals

Conditions: Medium-chain Acyl-CoA Dehydrogenase Deficiency

Summary: the aim of this project is to investigate the physiological effects of intake of long-chain fatty acids (lcfa) and medium-chain fatty acids (mcfa) in patients with medium-chain acyl-coa dehydrogenase deficiency (mcadd) and healthy individuals

male and female mcadd patients and healthy individuals will be included in this study which is a randomized intervention study in a cross over design consisting of two separate test days. the study involves two test days of four hours each, during which the participants ingests either medium-chain fatty acids (mcfa) or long-chain fatty acids (lcfa) in the form of triacylglycerol oils. the order of fatty acid oils ingested is determined by randomization.

Eligibility criteria:
inclusion criteria mcadd patients: * male or female * age between 18-80 years old * diagnosed medium-chain acyl-coa dehydrogenase deficiency (mcadd inclusion criteria healthy participants: * male or female * age between 18-80 years old exclusion criteria both mcadd patients and healthy participants: * diabetes * kidney- or liver disease * use of beta blockers or diuretics * pregnant, lactating or planning to become pregnant within the study period * regular intake of substantial amounts of coconut oil, palm kernel oil or any other source abundant in mcfa * ongoing cancer treatment * metabolic or absorptive disorders, gastric bypass operation, or use of medication affecting metabolism or food absorption * inability, physically or mentally, to comply with the procedure required by the study protocol as evaluated by the primary investigator, study manager or clinical responsible

Keywords: mcadd lipid metabolism ketone bodies medium-chain fatty acid (mcfa) long-chain fatty acid (lcfa)
a randomized, open label, prospective study to explore the clinical characteristics of oral mnk155 and norco 7.5mg/325 when used for the treatment of moderate to severe post operative pain

Conditions: Post Operative Pain

Summary: the purpose of this study is to explore the clinical characteristics oral mnk155 and norco® 7.5mg/325mg when used for the treatment of moderate to severe post operative pain.

this is a single center, open label, prospective, randomized study on adult post operative subjects who are expected to require oral opioid analgesia for at least 48 hours after surgery. the main study drug of interest in this study is mnk 155. norco® 7.5mg/325mg is being utilized only as active comparator. subjects will be at least 18 years of age and will be scheduled to undergo elective surgery. the following surgical types will be allowed, although the list is not all inclusive: * abdominal surgery * soft tissue surgery * orthopedic surgery * spine surgery * genitourinary surgery

Eligibility criteria:
inclusion criteria: 1. subjects who provide written informed consent prior to enrollment. 2. male or female and 18 years of age or older. 3. subjects who are scheduled to undergo elective general surgery including, but not limited to the following surgical types: * abdominal surgery * orthopedic surgery * spine surgery * genitourinary surgery 4. subjects classified as american society of anesthesiologists (asa class i-iii). 5. female subjects are eligible only if all of the following apply: * not pregnant (subjects of child bearing potential must have a negative beta human chorionic gonadotropin (β-hcg) pregnancy test before surgery); * not lactating; * not planning to become pregnant within the duration of the study; 6. subjects who are expected to have acute pain requiring oral opioid analgesics for at least 48 hours during the post operative period (either inpatient or outpatient). 7. subjects who are willing and capable of understanding and cooperating with the requirements of the study. 8. subjects able to understand and communicate in english. exclusion criteria: 1. subjects with a medical condition that, in the investigator's opinion, could adversely impact the subject's participation, safety, or conduct of the study such as but not limited to a history of severe renal or hepatic impairment, severe active hepatic disease, or any other clinically significant medical condition that may preclude safe study participation.
the effect of using interactive mobile application for the management of chemotherapy- induced nausea and vomiting in children

Conditions: Oncology; Nausea and Vomiting Chemotherapy-Induced; Pediatric Cancer; Mobile Application

Summary: the aim of this study was to develop an interactive mobile application and to investigate the effect of this application on the management of nausea and vomiting symptoms by using it during chemotherapy treatment.

intensive chemotherapy protocols are the most commonly used treatments in childhood cancers. while these protocols increase recovery rates, they may also cause some undesirable side effects. nausea and vomiting are one of the most common toxic side effects associated with chemotherapy. the aim of this study was to develop an interactive mobile application and to investigate the effect of this application on the management of nausea and vomiting symptoms by using it during chemotherapy treatment. the study will be conducted with 61 children between 8-18 years of age who received chemotherapy in the pediatric hematology-oncology clinic at trakya university health research and application center. the study was planned as a randomized controlled study. data will be collected with the "information form" and "rhodes adapted rhodes nausea and vomiting scale for children". the interactive mobile application will be downloaded to the phones of the experimental group and this device will be used from the first chemotherapy day to the seventh day. while the experimental group evaluates their nausea and vomiting via mobile application twice a day, every 12 hours for one week, the control group will record their nausea and vomiting experiences in the "nausea and vomiting diary". while the experimental group will be able to use the mobile application which consists of diverting attention, routine control will be applied to the control group.

Eligibility criteria:
inclusion criteria: * taking chemotherapy treatment, * to be in the age range of 8-18, * volunteering to participate in research, * having the first course of chemotherapy, exclusion criteria: * having a mental problem, * absence of vision, hearing and speech problems, * absence of problems with the gastrointestinal system, * being in the terminal period, * receiving sedation therapy,
non-invasive ablation of ventricular tachycardia

Conditions: Ventricular Tachycardia

Summary: phase i/ii study of 4-d navigated non-invasive radiosurgical ablation of ventricular tachycardia (nira-vt).

the goal of this project dealing with 4d-navigated substrate ablation is to evaluate the feasibility and safety of elimination of the scar-related monomorphic ventricular tachycardia (vt) or tachycardias by stereotactic radiosurgical ablation that is completely non-invasive. the arrhythmic substrate is defined as the scar after myocardial infarction (mi) described by transthoracic echocardiography (tte) and specified by pet-ct or mri. all sustained monomorphic vt induced by programmed ventricular stimulation via implanted icd (implantable cardioverter defibrillator) will be analyzed using body surface ecg mapping. the target volume for stereotactic radiosurgical ablation (single dose of 25 gy) will be based on accordance between a post-infarction scar (pet-ct or mri imaging) and arrhythmic substrate (body surface ecg mapping).

Eligibility criteria:
inclusion criteria: * history of sustained monomorphic vt or termination of monomorphic vt by icd (appropriate therapy) during previous 6 months prior to enrollment * implantation icd * inducibility at least one of monomorphic ventricular tachycardia by icd during ep study with programmed ventricular stimulation * history of myocardial infarction (mi) * left ventricular scar and decreased systolic function of the left ventricle (ejection fraction of left ventricle less than 40%) based on transthoracic ultrasound * stable chronic heart failure (nyha ii-iii) * older than 18 years * signed an irb approved written informed consent document. * failed at least one invasive catheter ablation procedure or have a contraindication to a catheter ablation procedure exclusion criteria: * acute myocardial infarction * chronic heart failure nyha iv * channelopathy * reversible cause of vt (e.g. ionic dysbalance, intoxications) * pregnancy or breastfeeding * history of chest radiotherapy * arrhythmic substrate larger than 100 ccm

Keywords: scar-related ventricular tachycardia substrate ablation stereotactic radiosurgery functional radiosurgery 4d navigation
prevalence, etiology and effects on oral health and life quality of molar incisor hypomineralization

Conditions: Molar Incisor Hypomineralization; Oral Health; Child, Only; Pediatric ALL; Dental Caries; Dental Plaque; Dental Diseases

Summary: molar incisor hypomineralization (mih) can lead to many clinical conditions and affect oral health-related quality of life (ohrqol).

molar incisor hypomineralization (mih) can lead to many clinical conditions and affect oral health-related quality of life (ohrqol). the aim of this study was to determine the prevalence, etiology and impacts of mih on oral health status and ohrqol. six hundred and fifty-five parents and their children aged 9 years were included in the study. after parents completed the questionnaire about the etiology of mih, children's ohrqol was measured by the child perceptions questionnaire (cpq8-10). children were evaluated for presence and severity of mih, dental caries experience and oral hygiene status. qualitative data were analyzed with the pearson chi-square and fisher's exact tests. for the quantitative data, if the normal distribution was not satisfied, kruskal wallis/mann-whitney u tests were used. also, binominal logistic regression analysis was performed and p\<0.05 was statistical significant. .

Eligibility criteria:
inclusion criteria: * being 9-year-old, * mentally and physically capable of completing the questionnaire, * presence of fully erupted 4 permanent molars and 8 permanent incisors. exclusion criteria: * children were receiving orthodontic treatment during the examination, * children had enamel hypoplasia or developmental defects, * children had amelogenesis imperfecta or dental fluorosis.

Keywords: molar incisor hypomineralization oral health mih oral health related lif quality child perceptions questionnaire ohrqol cpq
pharmacodynamic effects of cangrelor in acs or ccs patients undergoing pci (pompeii registry)

Conditions: Percutaneous Coronary Intervention

Summary: this prospective registry was designed to carefully investigate the pharmacodynamic (pd) effects of cangrelor in all patients undergoing percutaneous coronary intervention (pci).

there is huge interest in achieving fast and immediate antiplatelet effect at the time of pci, particularly in acute myocardial infarction and cangrelor is an intravenous antagonist of the p2y12 receptor characterized by rapid, potent, predictable, and reversible platelet inhibition. however, there are limited pharmacodynamic data exploring the effects of this drug in the various clinical settings at the approved dosages and with current gold standard methods for testing platelet reactivity. more importantly, there are no data on rates and predictors of high residual platelet reactivity (hrpr) in patients treated with cangrelor. therefore the present study aims at building up a large prospective registry of pharmacodynamic data obtained by light transmittance aggregometry (lta), multiplate analysis and verifynow system in patients undergoing pci and receiving cangrelor. this study is designed as a single-center prospective registry. investigators at university hospital of naples federico ii will enroll patients, collect blood samples, perform platelet function tests and collect clinical and demographic information.

Eligibility criteria:
inclusion criteria: * all adult patients undergoing pci and receiving cangrelor administration will be eligible for inclusion in the study. exclusion criteria: * only those not providing consent to blood/data collection will be excluded.

Keywords: cangrelor acute coronary syndrome chronic coronary syndrome
patient-reported quality of life in patients with an implantable-cardioverter defibrillator - a cross-sectional observational study

Conditions: Implantable Cardioverter Defibrillator (ICD)

Summary: patients at risk for life-threatening arrhythmias are eligible for the implantation of an implantable cardioverter-defibrillator (icd), which has repeatedly shown improved survival. however, living with an icd may pose several challenges and affect quality of life (qol). this prospective cross-sectional observational cohort studies will provide detailed insights in patient-reported qol. the aim is to study the qol perspective of patients who have an icd, including physical and emotional health; icd acceptance; concerns of icd patients with regard to physical and sexual activity.


Eligibility criteria:
inclusion criteria: * age ≥ 18 years of age * patients with any type of icd followed in uz leuven * willing and able to provide signed written informed consent exclusion criteria: * patients who are hospitalized * patients with a mental disability * patients already included in another interventional study

Keywords: implantable cardioverter defibrillator quality of life