Kornimate/medical-research-clean huggingface dataset:
early amiodarone in shockable cardiac arrest

Conditions: Cardiac Arrest

Summary: the primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care.

the primary objective of this pilot, pragmatic stepped-wedge cluster randomized trial is to evaluate if a modified cardiac arrest treatment algorithm calling for the administration of the initial amiodarone dose one 2-minute cycle earlier than current guidelines (during the same cycle as the initial dose of epinephrine) improves the time to amiodarone delivery in those with out-of-hospital cardiac arrest due to refractory ventricular fibrillation or ventricular tachycardia compared to usual care. the null hypothesis is that there is no difference in time to amiodarone delivery, relative to emergency medical services (ems) arrival on-scene or time of arrest if witnessed by ems, in the modified protocol calling for earlier amiodarone administration compared to usual care. evaluated secondary outcomes will include the proportion of patients receiving amiodarone before their third defibrillation, pulses present at emergency department arrival, survival to hospital discharge, neurologically intact survival at hospital discharge, timing to other critical ems interventions, and clinical adverse events.

Eligibility criteria:
inclusion criteria: * emergency medical services (ems)-treated non-traumatic out-of-hospital cardiac arrest * initial rhythm on ems rhythm assessment of ventricular fibrillation or ventricular tachycardia * recurrence or persistence of ventricular fibrillation or ventricular tachycardia after one defibrillation attempt exclusion criteria: * known allergy to amiodarone * ems-assessed contraindication to amiodarone * pre-existing "do-not-attempt-resuscitation" orders * inter-facility transportations * initial care by a non-participating ems agency able to perform advanced life support interventions * pediatric patient as determined by ems * prisoners * pregnant patients
tracheal tube cuff shape and pressure

Conditions: Intubation, Intratracheal; Pain, Postoperative; Dysphonia

Summary: this is a randomized controlled trial focusing on the effect of different tracheal tube cuff shape; the tapered-shaped tracheal tube cuff versus the cylindrical-shaped tracheal cuff in anterior cervical spine surgery.

high endotracheal cuff pressure (etcp) during surgical retractor splay associates with recurrent laryngeal nerve paresis/ palsy and results in post-anterior cervical spine surgery (post-acss) dysphonia. control of intraoperative etcp during acss may benefit voice outcome. the taper-shaped tracheal tube cuff was originally designed as a new strategy to reduce fluid leakage across the conventional cylindrical cuff and prevention of ventilator associated pneumonia. literature has revealed the just seal pressure for the tapered-shaped tracheal tube (tt) cuff was lower than conventional cylindrical cuff. therefore the investigators hypothesize that use of a tapered-shaped et cuff during the surgery can lead to a lower etcp during retractors splay and improve voice recovery after acss. in this study, 80 patients were randomized into 2 groups, to receive endotracheal intubation using taperguard tracheal tube (tapered- shaped cuff) or a conventional tracheal tube (a cylindrical cuff). the just seal pressure, intraoperative cuff pressure, and postoperative sore throat and voice outcome are recorded and compared.

Eligibility criteria:
inclusion criteria: * receiving elective anterior cervical spine surgery * right side approach exclusion criteria: * unstable cervical spine (acute trauma history, or dislocation/ subluxation in image studies) * anticipated difficult airway * facial anomaly that may hinder facemask ventilation * preoperative hoarseness or vocal cord palsy regardless of etiology * re-operation of cervical spine surgery or left side approach * bmi \>35 * operation field involved cervical spine c1 or c2 * unwilling to sign the informed consent * unwilling to finish the study
evaluation of the efficacy of four different non-invasive ventilation modes performed in the delivery room

Conditions: Respiratory Disease; Respiratory Insufficiency

Summary: evaluation of the efficacy of four different non-invasive ventilation modes performed in the delivery room in late preterm and term infants wıth respiratory distress

in this study, it is aimed to search the efficacy and comfort of the four different non-invasive ventilation modes in the delivery room. hhfnc, ncpap, nippv and nhfo modes are used for the respiratory distress of the late preterm and term babies.

Eligibility criteria:
inclusion criteria: * late preterm and term infants with respiratory distress exclusion criteria: * intubation for the respiratory distres. * major abnormalities

Keywords: respiratory distress, newborn, noninvasive ventilation
association between vegf-c and mirna and clinical non-small cell lung cancer and esophagus squamous cell carcinoma

Conditions: VEGFC Protein in Serum; VEGFC Protein in Non Small Cell Lung Cancer; VEGFC Protein in ESCC; CTTN Protein in ESCC; miR326 in ESCC and Non Small Cell Lung Cancer

Summary: lung cancer and esophageal cancer remain the leading causes of cancer death worldwide. the main problem is lack of effective tool in early detection that accounts for the poor outcome of cancer. clinically, over 80% of patients with cancer were at late stage when they were diagnosed. therefore, it is important for us to find the biomarker that serve as the early prediction of cancer. the investigators have published that vegfc over-expressed in non-small cell lung cancer. vegfc plays a critical role in regulating motility of tumor cells, promotes proliferation of lymphatic endothelial cells and enhances migration and invasion. investigator found that vegfc over-expressed in the serum of esophageal cancer patients. therefore, it is worthwhile to investigate the correlation between vegfc, clinical lung cancer and esophageal cancer. micrornas (mirnas) are conserved, endogenous, small, and noncoding rna molecules of 21\~23 nucleotides that function as post-transcriptional gene regulators. recent studies indicated that certain micrornas reduced in cancer patients. therefore it is important to investigate whether specific microrna changed in certain kinds of cancer patients.


Eligibility criteria:
inclusion criteria: * tumor size \> 0.5 cm3 exclusion criteria: * tumor size \< 0.5 cm3

Keywords: vegfc cttn mir326 escc nsclc
anthropometric angular measurement to determine muscle tonus in patients with peripheral facial paralysis

Conditions: Peripheral Facial Paralysis

Summary: the current study sought to determine the reliability of the rehabilitation protocol using the labial commissure angle (lca) as an indicator of both muscle tonus and therapeutic success. the investigators hypothesized that this measurement would provide objective data regarding the efficacy of rehabilitation for these challenging patients.

context and objective: in cases of peripheral facial paralysis (pfp), diminished facial movements and their resultant cosmetic sequelae may have significant emotional repercussions, in addition to producing pronounced functional deficits. abnormal muscle proprioception and deviation of the nasal-labial filter may also interfere with articulation of the labiodental and bilabial phonemes, thus diminishing speech intelligibility. in relation to stomatognathic functions, weakened labial occlusion decreases intraoral pressure, thereby hindering liquid retention in the buccal cavity and giving rise to vestibular stasis on the paralyzed side. the aim of this study was to evaluate the reliability of the labial commissure angle (lca) as an anthropometric marker for objectively assessing changes in facial muscle tonus.

Eligibility criteria:
inclusion criteria: * age range between 20 and 70 years * incomplete pfp (degree iv) * integral facial nerve (fn) exclusion criteria: * systemic disease * potentially aggravating the pfp (neurological, degenerative, endocrinological)

Keywords: facial paralysis muscle tonus rehabilitation myofunctional stomatognathic system
interventions to improve non-communicable disease management during the pandemic

Conditions: Noncommunicable Diseases; COVID-19

Summary: this randomized controlled trial aims to implement and evaluate a comprehensive package of digital health interventions for integrated covid-non-communicable diseases (ncds) care to manage ncds in primary care facilities in rural pakistan. the main questions it aims to answer are 1) whether such interventions are effective; 2) how they were implemented; and 3) whether such interventions are cost-effective. 30 rural health centers in punjab province, pakistan will be randomized into two groups. the intervention group will provide a comprehensive package of digital health interventions to connect patients, patient champions, and public health providers to improve the management of ncds during the pandemic, including 1) providing training to health providers regarding an integrated ncd-covid guideline; 2) using a smartphone app to improve ncd case management and linking with patient champions; and 3) employing telementoring platform to improve quality of care. usual care will be provided in the control group. researchers will compare the two groups to see if the systolic blood pressure can be controlled better in the intervention group at 10 months.


Eligibility criteria:
inclusion criteria: * reside in the catchment of selected rural health centers; * provide informed consent; * newly diagnosed of hypertension, i.e., having a baseline blood pressure reading (recorded from the second blood pressure reading using a validated electronic blood pressure machine) of more than 140/90 mmhg; or who is an existing hypertensive patient but with uncontrolled blood pressure with a baseline blood pressure over 140/90 mmhg; * have a smartphone or can access a smartphone from a relative. exclusion criteria: * patients having an acute cardiovascular event in the last three months, terminal disease, or other conditions that the rural health center staff determine that will make participation impossible.

Keywords: digital health interventions non-communicable diseases cluster randomised trial implementation science resilience pakistan
peek bar versus titanium bar fabricated by cad-cam in mandibular hybrid prostheses: a comparative study

Conditions: Edentulous Jaw

Summary: cad/cam-fabricated peek bar exhibited greater dimensional deviation in comparison to its titanium counterpart. nevertheless, patients with peek bars reported higher satisfaction levels and lower marginal bone loss when compared to those with titanium bars.

fourteen patients with completely edentulous mandibular arch opposing natural dentition were selected and divided into two groups, seven patients in each. all patients received implant-supported hybrid prostheses with a bar fabricated by cad/cam milling technique. in group i (control), bar was fabricated from titanium, while in group ӏӏ, the bar was fabricated from peek. the evaluation of the study was done at 6 and 12 follow-up periods according to the following: 1- experimentally by geomagic (geomagic, japan) to detect any dimensional deviation of peek bars compared to titanium bars. 2-clinically by questionnaire to evaluate the patient satisfaction. 3- radiographically (digital periapical) to measure marginal bone loss around the implants.

Eligibility criteria:
inclusion criteria: * completely edentulous mandibular arch for at least six months have almost of the natural teeth in the maxillary arch with a ranged of age from 40- 60 years old. and normal class ӏ maxilla-mandibular relationship with a minimum 12-15 mm inter-arch space exclusion criteria: * all patient had systemic disorders that may influence soft or hard tissue healing were excluded as: * history of radiation therapy in the head and neck region. * active infection or inflammation or flabby tissue in the mandibular arch * bone diseases as osteoporosis. * clenching or bruxism, temporomandibular joint troubles * neurological or psychiatric handicap conditions that could interfere with good oral hygiene. * heavy smoking and drug abusing

Keywords: hybrid prosthesis, polyether-ether-ketone,
effect of individual and populational determinants on end stage renal disease children quality of life, during dialysis period.

Conditions: Kidney Dysfunctions

Summary: end stage renal disease (esrd) is a severe pathology, treated by dialysis on standby of graft availability. being under dialysis requires a recourse to pluri-weekly magazine of health care system, impacting negatively patient's quality of life (qol) and their entourage, at a psychological, physical and social level. although further studies have assessed qol in esrd grafted children, a lack of information exists concerning patients' qol during dialysis before graft. in addition, some limits could be listed, these studies have small samples, 50 patients at all, and only clinical determinants are studied. a larger clinical research assessing children's qol studying individual and populational factors is necessary. the aim of the study is to assess the influence of individual and populational determinants on children's qol with esrd, treated by dialysis. material \& method an exhaustive inclusion of patient with esrd treated by dialysis will be realized at 20 french pediatrics dialysis centers. inclusion criteria are i) two genders, ii) younger than 18 years old, iii) having an esrd treated by dialysis, iv) attending at one of the french pediatrics dialysis centers for treatment between the 1st september 2012 and the 31th august 2014, v) being at their fourth to sixth week of dialysis. patients will be re-evaluated at 4th month and 7th month after first dialysis. informed consent will be signed by patient and their mainly caregiver. patient's qol will be assessed using self-administered questionnaires kidscreen 10 and vsp-a. in addition coping (kidcope), anxiety (stai-c, stai-y), personality / attachment (ippa), optimism (y-lot) measures and socio-demographic data will be collected. self-administered questionnaires will be used for assessing caregivers' qol (sf36), anxiety (stai-y), coping (briefcope situational format), health care system satisfaction (care quality scale) and burden (zarit caregiver burden inventory). child's qol evaluated by caregivers will be assessed using qualin, kidscreen 10 parent and vsp-ap. in addition, socio-demographic data, urban environment and economic environment will be collected. clinical data will be collected by health professionals. results expected a sample of 136 children with esrd is expected for identifying individual and populational factors which could influence chronic dialysed children qol, in order to propose adjustments to optimize these patients quality of life.


Eligibility criteria:
inclusion criteria: * minors patients treated by dialysis or on standby of graft availability exclusion criteria: * minors patients treated by dialysis for less than 4 weeks
a study to evaluate the safety and effectiveness of saroglitazar 4 mg in patients with nafld with comorbidities

Conditions: NAFLD; Obesity; Type 2 Diabetes; Dyslipidemias; Metabolic Syndrome

Summary: a phase 4, non-randomized, multicentre, open-label, single-arm study to evaluate the safety and efficacy of saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (nafld) with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).

the study is being planned to evaluate long term safety and efficacy of saroglitazar 4 mg in patients with non-alcoholic fatty liver disease (nafld). total 1500 male and female patients with nafld with comorbidities (either obesity, type 2 diabetes mellitus, dyslipidemia or metabolic syndrome).

Eligibility criteria:
inclusion criteria: 1. male and female patients aged ≥18 years 2. patients who have been prescribed saroglitazar for nafld will be included in this phase 4 study (patients who use saroglitazar for the first time) 3. patients able to and willing to provide written informed consent and comply with the requirements of the study protocol . 4. patients with a prior documented diagnosis of nafld based on the aasld criteria. nafld is defined either by previous histology or clinical imaging in individuals who consume little or no alcohol and do not have a cause for secondary hepatic steatosis or another cause of chronic liver disease. in addition, patients must have one of the following criteria to indicate ongoing nafld at screening: 1. liver stiffness through transient elastography, an lsm ≥8 kpa or 2. serum alt ≥45 u/l exclusion criteria: 1. consumption of alcohol for at least 90 consecutive days in last one year: \>2 units of alcohol per day (\>14 units per week) for males and \>1 unit of alcohol per day (\>7 units per week) for females. note: 1 unit = 360 ml of beer, or 120 ml of wine, or 30 ml of spirits/hard liquor 2. history of other chronic liver disease (viral hepatitis b or c, autoimmune hepatitis, cholestatic and metabolic liver diseases) and haemochromatosis. 3. patient has known documented cirrhosis, either based on clinical criteria or liver histology or imaging. 4. contraindications to saroglitazar or any disease conditions affecting the ability to evaluate the effects of saroglitazar. 5. history or other evidences of severe illness or any other conditions that would make patient, in the opinion of the investigator, unsuitable for the study. 6. any previous history of ascites, hepatic encephalopathy, oesophageal varices or admission/emergency department visit for hepatic decompensation. 7. women of child bearing potential: inability or unwillingness to practice contraception for the duration of the study. 8. pregnant or breast feeding females

Keywords: real world evidence study
effects of transcutaneous vagus nerve stimulation (tavns) in individuals with primary dysmenorrhea

Conditions: Dysmenorrhea Primary; Pain

Summary: this study aims to investigate the effects of transcutaneous auricular vagus nerve stimulation (tavns) on pain, functional and emotional symptoms, and physical performance in individuals with primary dysmenorrhea (pd).

in this study, which will be conducted over two menstrual cycles, 34 patients with pd will be randomised into two groups: tavns and sham treatment. from the onset of pain during the menstrual cycle, tavns or sham treatment will be applied for five days. pain assessment will be conducted using the numerical rating scale (nrs), pressure pain threshold with an algometer, menstrual symptoms using the menstrual symptom scale (mss) and the functional and emotional measure of dysmenorrhea (femd), anxiety using the hamilton anxiety scale (ham-a), and physical performance using the 6-minute walk test (6mwt) during the first and second menstruation.

Eligibility criteria:
inclusion criteria: * being diagnosed with pd according to the no. 345 primary dysmenorrhea consensus guidelines, * an nrs score of at least three during menstruation before treatment, * being a woman between the ages of 18-40, * a regular menstrual cycle of 28±7 days, * being nulliparous, * no history of brain surgery, tumour or intracranial metal implantation, * no chronic genitourinary infection or alcohol or drug use. exclusion criteria: * history of dizziness or epileptic disease, * pregnancy, * women with intrauterine devices, * metal implants in the head area, * women with skin lesions in the area where the electrodes will be placed, * use of analgesic drugs during treatment, * women with neurological or heart disease, * women are diagnosed with gynaecological conditions (endometriosis, adenomyosis, uterine fibroids, etc., which may be associated with secondary dysmenorrhea).

Keywords: dysmenorrhea menstrual cycle pain function
a safety and efficacy study of lys-gm101 gene therapy in patients with gm1 gangliosidosis

Conditions: GM1 Gangliosidosis

Summary: lys-gm101 is a gene therapy for gm1 gangliosidosis intended to deliver a functional copy of the glb1 gene to the central nervous system. this study will assess, in a 2-stage adaptive-design, the safety and efficacy of treatment in subjects with infantile gm1 gangliosidosis.

gm1 gangliosidosis is a fatal autosomal recessive disease caused by mutations in the glb1 gene leading to accumulation of gm1 ganglioside in neurons and progressive neurodegeneration. there are three pediatric subtypes: early infantile, late infantile and juvenile. this is an interventional, multicenter, single-arm, 2-stage adaptive design study of lys-gm101 for which the first stage (stage 1) is for safety evaluation (fih) and the second stage (stage 2) will establish efficacy as compared to the natural history of the disease. the participants with infantile gm1 gangliosidosis will receive a single dose of lys-gm101 by intracisternal injection. after a two-year evaluation period (main part of the study), each participant will be followed for an additional three-year long-term follow-up period.

Eligibility criteria:
inclusion criteria: * documented gm1 gangliosidosis diagnosis based on genotyping confirming the β-gal gene mutations and/or documented deficiency of β-gal enzyme by laboratory testing * children with early infantile gm1 gangliosidosis less than 12 months of age with ability to swallow * children with late infantile gm1 gangliosidosis less than 3 years of age with ability to sit exclusion criteria: * uncontrolled seizure disorder. patients who are stable on anti-convulsive medications may be included * more than 40% brain atrophy as measured by mri total brain volume at screening * current participation in a clinical trial of another investigational medicinal product * past participation in a gene therapy trial * history of hematopoietic stem cell transplantation * any condition that would contraindicate treatment with immunosuppressant therapy * presence of concomitant medical condition or anatomical abnormality precluding lumbar puncture or intracisternal injection * presence of any permanent items (e.g., metal braces) precluding undergoing mri * history of non-gm1 gangliosidosis medical condition that would confound scientific rigor or interpretation of results * rare and unrelated serious comorbidities, e.g., down syndrome, intraventricular hemorrhage in the new-born period, extreme low birth weight (\<1500 grams) or known bleeding disorders * any vaccination 1 month prior to the planned immunosuppressant treatment * serology consistent with hiv exposure or consistent with active hepatitis b or c infection * grade 2 or higher lab abnormalities for liver function tests (lft), bilirubin, creatinine, hemoglobin, white blood cell (wbc) count, platelet count, prothrombin time (pt), and partial thromboplastin time (ptt), according to ctcae v5.0

Keywords: gm1 gangliosidosis lysosomal storage disease landing disease