Kornimate/medical-research-clean huggingface dataset:
interventions to promote healthy eating and physical activity in lebanese school children targeting overweight and obesity.

Conditions: Childhood Obesity

Summary: evaluate the feasibility and effectiveness of a multi-component school-based intervention to promote healthy eating and physical activity with school children ages 9 to 11 years in lebanon.


Eligibility criteria:
inclusion criteria: * schoolchildren * aged 9 to 11 years exclusion criteria: - no exclusion criteria

Keywords: school-based intervention
a study comparing duloxetine and placebo in assessing energy and vitality in major depressive disorder (mdd) patients

Conditions: Major Depressive Disorder

Summary: study f1j-us-hmfs comprises two identical multicenter, 9-month, randomized, placebo-controlled, double-blind, trials (hmfsa and hmfsb). the purpose of this study is to compare the efficacy and safety of duloxetine 60 milligrams (mg) once daily to placebo on depression in patients aged 18-65. data from the two trials will be reported in both individual and pooled analyses. pooling the two studies will allow for increased power to detect differences between duloxetine and placebo on secondary and exploratory objectives. only one data lock is planned for this study, when all patients have completed all study procedures.


Eligibility criteria:
inclusion criteria: * male or female outpatients * aged 18-65 who meet the diagnostic and statistical manual of mental disorders fourth edition, text revision (dsm-iv-tr) diagnostic criteria for major depressive disorder (mdd) * have a montgomery-asberg depression rating scale (madrs) total score of at least 22 at visits 1 and 2 * have a clinical global impressions of severity scale (cgi-s) score of at least 4 at visits 1 and 2 * have a degree of understanding such that the patient can provide informed consent, complete protocol required assessments and communicate intelligibly with the investigator and study coordinator. exclusion criteria: * patients judged clinically to be at serious suicidal risk in the opinion of the investigator * patients who have any prior history of bipolar disorder, psychosis, or schizophrenia * patients who have any current (within the past six months) dsm-iv-tr primary axis i disorder other than mdd * patients with uncontrolled narrow-angle glaucoma * patients who have a serious medical illness that is in the opinion of the investigator not stabilized or is likely to require intervention, hospitalization, or use of an excluded medication during the course of the study.
self-management using smartphone application for type2 dm in real situation (smart-dm)

Conditions: Type 2 Diabetes Mellitus

Summary: the purpose of this study is to evaluate the effectiveness of smartphone application for management of type 2 diabetes mellitus (dm). type 2 dm is an almost incurable chronic disease and continuous management is important for long-term prognosis. however, patient's compliance to conventional medical intervention is generally unsatisfactory and many patients feel difficult to access to the detail medical advice for type 2 dm. thus, the investigators developed a smartphone application for giving programed medical intervention to patients according to patients data; blood pressure, fasting blood sugar, body weight, calorie intake,exercise amount, etc.


Eligibility criteria:
inclusion criteria: * type 2 dm using oral hypoglycemic agent * 6.5% \< hba1c \< 10% * systolic blood pressure \> 130 mmhg or diastolic blood pressure \> 80 mmhg * bmi over 23.0 * 20 \< age \< 70 * smartphone user (android os based) exclusion criteria: * serum fasting glucose \> 250 mg/l or post prandial 2 hour serum glucose \> 350 mg/l * systolic blood pressure \> 180 mmhg or diastolic blood pressure \> 110 mmhg * diabetes mellitus patient using insulin * severe chronic diabetic complications (diabetic foot ulcer, severe diabetic retinopathy, diabetic nephropathy with severe proteinuria) * congestive heart failure (nyha iii-iv or left ventricular ejection fraction \< 30%) * aspartate aminotransferase (ast) or alanine transaminase (alt) over 3 times of upper normal limit * serum creatinine \> 1.5 mg/dl * refusal to participate in the study * drug addiction or alcohol addiction * major psychiatric illness * steroid treatment or hormonal treatment with changing the drug or drug dosage in 1 month * changing dosage of antihypertensive agent, oral hypoglycemic agent or lipid lowering agent in 1 month * malignant cancer * pregnancy

Keywords: t2dm smartphone application serum fasting glucose hba1c
medication review in women with depression and anxiety

Conditions: Depression, Anxiety; Adherence, Patient

Summary: this study sought to assess the impact of the mmr service on identifying and resolving trps, improving adherence, depression and anxiety scores in females diagnosed with depression and anxiety in jordan

participants were recruited into this single-blind parallel randomized controlled trial and randomized into active and control groups. a clinical pharmacist identified trps for all participants. adherence, depression and anxiety scores were assessed. active group patients received the mmr service: pharmacist-delivered counseling and a letter with recommended changes in the patient's treatment plan was sent to the patient's psychiatrist to be applied. control group participants did not receive the intervention. follow-up assessments were completed for all patients at 3 months from baseline. main outcome measures were trps, adherence, depression and anxiety scores.

Eligibility criteria:
inclusion criteria: * jordanian females or residents in jordan for the last 12 months and planning to stay in jordan for 6 months (the study follow-up period), * above the age of 18 years * diagnosed with depression and/or anxiety for at least 4 weeks duration * taking medications for depression and/or anxiety exclusion criteria: * presence of a cognitive problem or sensory impairment which may prevent communication with the patient (reported by the patient's psychiatrist) * being not able to speak or write arabic (reported by the patient)

Keywords: medication management review service pharmaceutical care clinical pharmacist
airway pressure release ventilation as a preventative strategy

Conditions: Acute Respiratory Distress Syndrome; Acute Lung Injury; Respiratory Failure; Trauma

Summary: the early initiation of airway pressure release ventilation in multi-system trauma patients decreases the incidence and severity of acute lung injury and acute respiratory distress syndrome and allows faster recovery of lung function.


Eligibility criteria:
inclusion criteria: * trauma patients age 16 or older * trauma patients requiring ventilatory support within 48 hours of injury * those with anticipated ventilatory support ≥ 24 hours * subject or authorized representative (ar) has signed an informed consent form (icf) * subjects age 16 or 17 who have signed an assent document and/or ar has signed an icf exclusion criteria: * significant chronic lung disease defined as lung pathology requiring home o2 use * chronic heart disease defined as nyhc iii or higher * persistent bronchopulmonary air leak * contraindications to permissive hypercapnia (ex. intracerebral bleeding, brain tumor, fulminant hepatic failure, and hemodynamic instability) * pulmonary artery occlusion pressures ≥ 18 mmhg * severe neurologic injury that may prevent the patient from having a reasonable opportunity for weaning as determined by the clinical study team * immuno-compromised patients secondary to drugs or disease * neuromuscular disease that impairs ability to ventilate spontaneously (ex. spinal injury at or above c5, als, guillain-barre syndrome, myasthenia gravis) * history of pneumonectomy * pregnancy * burns with tbsa ≥ 20% * acute mi as the cause of ali/ards * all other contraindications to aprv * patients who cannot be randomized within 12 hours of intubation

Keywords: acute respiratory distress syndrome acute lung injury airway pressure release ventilation ardsnet bi-level respiratory failure trauma aprv
safety and efficacy of the addition of 0.3% lidocaine with evolence®

Conditions: Aging; Pain

Summary: the study doctor will give evolence® mixed with lidocaine to people in this study to see if it effectively reduces pain while injecting and works to correct nasolabial wrinkles. the product being used in this study is evolence®, which is currently marketed in the united states for the cosmetic correction of soft tissue contour deficiencies (including wrinkles), and been approved by the u.s. food and drug administration (fda).

the aim of this study is to determine if the admixture of lidocaine can effectively be used to mediate pain relief during the injection of evolence® while achieving cosmetic correction.

Eligibility criteria:
inclusion criteria: * understanding and voluntary signature (including date) of an informed consent document * healthy male or female \> 18 years of age * clinical evidence of bilateral, fully visible aging defects in the nasolabial area with grades 2.0, 2.5, or 3.0 on the modified fitzpatrick wrinkle scale (mfws section 6.5) * willingness to receive evolence® injections in areas of aging defects (wrinkles) * willingness and ability to comply with the requirements of this protocol exclusion criteria: * history of multiple severe allergies (food, drug, or substances) and/or anaphylactic shock * subjects with a history of a bleeding disorder, or receiving chronic anti-platelet therapy or other chronic anticoagulant medication * subject on low-dose aspirin therapy or a non-steroidal anti-inflammatory drug, not interrupted at least 10 days prior to injection and/or resumed within 1 week after injection * history of allergies and/or sensitivity to porcine, bovine and human collagen, lidocaine, local anesthetics products or natural rubber latex * autoimmune or collagen vascular disease, or connective tissue disease * active skin disease, inflammation or related condition such as infection, psoriasis and herpes zoster near or on the nasolabial folds area at study entry and/or within 6 months prior to study entry * previous tissue augmentation - permanent implants or hyaluronic acid within 6 months or evolence® within 12 months in the treatment area * currently being treated with immunosuppressive drugs, chemotherapy agents or systemic steroids or has been treated within the last 3 months prior to study entry * botulinum-toxin a within 6 weeks in treatment area * received any investigational products within 30 days prior to the study enrollment * females of childbearing potential * any clinically significant organic disease or other medical condition that in the opinion of the pi, makes the subject a poor candidate for participation in the study

Keywords: wrinkles dermal filler collagen soft tissue augmentation lidocaine aesthetic
wound infiltration with sodium diclofenac vs bupivacaine for postoperative pain following appendectomy

Conditions: Postoperative Pain

Summary: the infiltration of the surgical wound is an effective strategy for postoperative analgesia. nonsteroidal antiinflammatories are useful in this way. objective: to compare the analgesic effectiveness of diclofenac sodium, bupivacaine or bupivacaine plus diclofenac sodium infiltrating wound appendectomies. method: comparative, double blind, american society anesthesiologist classification i-ii,18-65años. group 1 (bupivacaine n = 14), group 2 (diclofenac sodium n = 14), group 3 (bupivacaine + diclofenac sodium n = 15). pain at rest and dynamic, rescue analgesic consumption in post anesthesia care unit (pacu) and 24 hours after surgery were evaluated.


Eligibility criteria:
inclusion criteria: * american society anesthesiologist i- ii * aged 18 and 65 * both sexes * patients diagnosed with acute appendicitis operated under general anesthesia exclusion criteria: * patients known to any allergy of the drugs used in the study * different incision approach mc burney * some intraoperative surgical complications * pregnant patients
pain in newborn heel blood collection

Conditions: Infant, Newborn, Disease; Pain, Acute

Summary: this study was conducted to evaluate the effect of white noise and therapeutic touch on pain in newborn heel blood collection.questions including the sex of the newborns, postnatal age, gestational age, birth weight, height, head and chest circumference, feeding style, nutritional status in the last half hour, and previous heel blood collection were collected with the "information form".the newborn infant pain scale (nips) was used to evaluate the pain levels of newborns.


Eligibility criteria:
inclusion criteria: * gestational week 37 and above, * fasting time \< 1 hour, * without comorbidity and congenital anomalies, * not receiving oxygen or mechanical respiratory support, * no analgesic sedation before the procedure * neonates with stable physiological findings before the procedure exclusion criteria: • newborns whose heel blood cannot be taken at once
alternative vs. once-daily oral iron supplementation in iron deficiency anemia (ida)

Conditions: Iron Deficiency Anemia Treatment

Summary: the goal of this clinical trial is to compare the effectiveness and tolerability of two different oral iron regimens in adults with iron deficiency anemia (ida). the main questions it aims to answer are: is alternate-day oral iron supplementation as effective as once-daily dosing in improving hemoglobin levels? what are the side effects associated with each dosing regimen? researchers will compare once-daily vs. alternate-day oral ferrous fumarate to evaluate whether alternate-day dosing is non-inferior in terms of hematologic response, with fewer adverse effects. participants will: be randomly assigned to take ferrous fumarate 200 mg once daily or 400 mg on alternate days for 8 weeks undergo blood tests and clinical assessments at baseline, week 4, and week 8 report any side effects and bring remaining pills to evaluate medication adherence this is a multicenter, randomized, open-label, non-inferiority trial conducted in adults aged 20 years or older with ida.


Eligibility criteria:
inclusion criteria: * male or female patients aged ≥20 years diagnosed with iron deficiency anemia, defined as: hemoglobin (hb) \<13 g/dl in males or \<12 g/dl in females, and ferritin \<50 ng/ml or transferrin saturation (tsat) \<20%. * no iron supplementation within the past 3 months. exclusion criteria: * hemodynamic instability (e.g., acute bleeding or hypotension). * severe heart failure (new york heart association \[nyha\] class iii-iv) or other active cardiac diseases. * active malignancy or history of cancer within the past 3 years (except non-melanoma skin cancer). * pregnancy or breastfeeding. * chronic liver disease including cirrhosis (child-pugh class b or c). * chronic kidney disease (estimated glomerular filtration rate \[egfr\] \<60 ml/min/1.73 m²). * clinically significant thalassemia or hemoglobinopathies. * ongoing infection or chronic inflammatory diseases (e.g., rheumatoid arthritis, inflammatory bowel disease). * malabsorption disorders (e.g., history of bariatric surgery). * red blood cell transfusion within the past 3 months.

Keywords: iron deficiency anemia ferrous fumarate alternate day dosing hemoglobin
study of aripiprazole in the treatment of children and adolescents with autistic disorder (ad)

Conditions: Behavioral Symptoms; Autistic Disorder

Summary: this study will compare the effectiveness (how well the drug works) of aripiprazole with placebo (fixed dose) in reducing serious behavioral problems in children and adolescents with a diagnosis of autistic disorder (ad).


Eligibility criteria:
inclusion criteria: * meets current diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv-tr) diagnostic criteria for ad and demonstrates serious behavioral problems; diagnosis confirmed by autism, diagnostic interview-revised (adi-r). * cgi score \> = 4 and an abc irritability/agitation subscale score \> = 18 at screening and baseline (randomization) * mental age of at least 18 months * male or female 6 to 17 years of age inclusive, at the time of randomization exclusion criteria: * patients considered treatment resistant to neuroleptic medication based on lack of therapeutic response to 2 different neuroleptics after treatment of at least 3 weeks each * patients previously treated and not responding to aripiprazole treatment * the patient is currently diagnosed with another disorder on the autism spectrum, including pdd-nos, asperger's disorder, rett's disorder, fragile-x syndrome or childhood disintegrative disorder * current diagnosis of bipolar disorder, psychosis, schizophrenia, or major depression * a seizure in the past year * history of severe head trauma or stroke * non-pharmacologic therapy (e.g., psychotherapy, behavior modification) should be stable prior to screening and consistent throughout the study

Keywords: serious behavioral problems in children and adolescents with ad
injection site diversity influences ha distribution and clinical results in cp and koa

Conditions: Osteoarthritis, Knee; Hyaluronan

Summary: in order to investigate the difference of intra-articular hyaluronate's distribution and compare the clinical outcomes of viscosupplementation for mild-to-moderate knee osteoarthritis (mkoa) between the anteromedial (am) and medial midpatellar (mmp) approach groups. this study included two parts, cadaver study (n=64) and random controlled trial (n=100). hyaluronic acid (ha) traced by methylene blue was injected into the knee, and the intra-articular distribution of ha was assessed using a five-point scale in the cadaver study. the clinical outcomes of 5-weekly injections of ha were evaluated by womac and lequesne index and the follow-up times were at weeks 1, 2, 3, 4, 5, 14, and 24 after the injections in the random controlled trial.


Eligibility criteria:
inclusion criteria: * symptomatic unilateral mild-to-moderate knee osteoarthritis (mkoa) that were defined by the american college of rheumatology criteria * kellgren-lawrence grade 2 or 3 * western ontario and mcmaster universities (womac) osteoarthritis index (likert version 3.1) pain subscale reached 10 or greater exclusion criteria: * pregnancy, acute fracture, rheumatoid arthritis, gouty arthritis, traumatic arthritis, inflammatory arthritis * oral celebrex within 2 weeks, ha and lidocaine allergy, intra-articular injection of ha or corticosteroid to the target knee within the past 6 months * surgery in the target knee within the past 6 months, oa of the target knee with k-l grade 4 * active liver and renal disease, cardiovascular and cerebrovascular disease.

Keywords: viscosupplementation hyaluronate distribution knee osteoarthritis injection approach
cg future® annuloplasty ring/band clinical trial

Conditions: Mitral Valve Insufficiency

Summary: the primary goal of the study is to document the number of patients that are successfully implanted and benefit from the implantation of both a cg future annuloplasty ring or a band.


Eligibility criteria:
inclusion criteria: * signed and dated the patient informed consent (pic); * indicated to have a surgical repair for a given degree of moderate to severe mitral valve regurgitation; * willing to return to the implanting hospital for a 9 month follow-up visit exclusion criteria: * unwilling or inability to sign the pic; * already participating in another investigational device study, if this would create bias and jeopardize scientific appropriate assessment of the current study endpoints; * life expectancy of less than one year; * pregnant or desire to be pregnant within 12 months of the study treatment; * less than 18 years and more than 85 years of age.
non-invasive onsd-based neuromonitoring in a neurointensive care setting

Conditions: Trauma, Brain; Subarachnoid Hemorrhage; Intracranial Hypertension

Summary: intensive care patients with established invasive intracranial neuromonitoring due to neurotrauma are subjected to a repeated non-invasive sonographic recording of the optic-nerve-sheath-diameter (onsd). the recorded images are analyzed through a machine-learning-algorithm and an experienced ultrasound operator. results are correlated to the parallel recorded intracranial pressure (icp). the study aims to establish onsd as a supplementary for raised icp.

during the intensive care stay, patients with implemented invasive intracranial pressure monitoring will have sonographic recording of the optic nerve sheath (video clip) with a parallel recording of the underlying icp. the obtained image material is then i) analyzed by a machine-learning algorithm and ii) manually by 2 blinded differently experienced examiners (expert, novice) with respect to the onsd. for the manual procedure, three individual measurements are made for each eye and the mean value is determined. subsequently, the measured values of the two examiners and the automated procedure are correlated with the icp recorded during the sonographic examination.

Eligibility criteria:
inclusion criteria: * traumatic or non-traumatic (e.g. sah) brain injury * established invasive intracranial pressure monitoring (either intraparenchymal or intraventricular) exclusion criteria: * soft tissue damage to orbital or periorbital region * fracture of the orbita * status post decompressive craniectomy
looking at the physiological response of ergometry in critical care patients

Conditions: Critical Ill Patients

Summary: exploring the physiological and metabolic demands of passive ergometry in the critical ill patient.

this study explores the physiological and metabolic demands of passive ergometry as a step in active rehabilitation and compares two methods of monitoring these changes in critically ill patients.

Eligibility criteria:
inclusion criteria * already on the early mobility programme (emp) * cardiovascularly stable (stable vasopressor dose for two hours) * stable heart rate (\<140 bpm) and heart rhythm * presence of a jugular central venous pressure (cvp) line and arterial line. exclusion criteria * prior rapidly deteriorating neuromuscular disease * upper limb problem precluding cycle ergometry * pyrexia (temp \>38 °c) * raised intracranial pressure * poor prognostic outcomes * lack of agreement from clinician * next of kin/legal representative (nok/lr) not understanding english.

Keywords: early rehabilitation physiological response critical care