cyrilzakka/clinical-trials huggingface dataset:
Study of Metabolic Dysfunction-Associated Steatotic Liver Disease Among Sohag University Employees

* Metabolic dysfunction-associated steatotic liver disease (MASLD) is the latest term for steatotic liver disease associated with metabolic syndrome. MASLD is a common cause of chronic liver disease and is the leading cause of liver-related morbidity and mortality.
* The high prevalence of this disease has been fueled by the rapid rise in levels of sedentary behavior, low levels of physical activity, excess calorie intake relative to expenditure in nutritionally imbalanced and unhealthy diets. In parallel, the prevalence of poor metabolic health in adults from many countries is high, even in normal weight individuals.
* MASLD has been estimated to affect 30% of the adult population worldwide, with its prevalence increasing from 22% to 37% from 1991 to 2019 . The increasing prevalence of MASLD parallels the increasing prevalence of obesity and obesity-related diseases.


Eligibility Criteria:
Inclusion Criteria:

* 100 Employees in Sohag University will be included in the study.

Exclusion Criteria:

Employees with drug induced liver disease. Employees with chronic liver disease. Employees with decompensated liver cirrhosis. Employees with excessive alcohol consumption.
Ambu AuraGain vs LMA Supreme in Laparoscopic Surgery

The aim of the study is to compare the performance of two supraglottic airway devices (SGA), the new Ambu AuraGain and the LMA Supreme, in sixty female patients undergoing gynaecologic laparoscopy in the trendelemburg position.

Primary outcome is the airway seal pressure. Secondary outcomes are ease of insertion, quality of ventilation, endoscopic view of the glottis, gastric tube passage and complications.

The patients are randomly assigned to 2 groups:

* Group 1: Ambu AuraGain.
* Group 2: LMA Supreme, Teleflex

Procedure:

The investigation protocol contains the following sections:

1. Induction of anaesthesia. Intravenous infusion of remifentanil and propofol targeting the effect site (2-4 ng/ml and 4-6 µg/ml respectively). No muscle relaxant will be used for insertion of the SGA. Rocuronium 0.2 mg/Kg will be administered before initiation of pneumoperitoneum.
2. Insertion of the SGAs. The size of the SGA device used is based on the manufacturers' recommendations. All devices are deflated a lubricated prior to use. Once inserted, the cuff is be inflated with a manometer up to 60 cm H20 Position of the device is adjusted if needed. Data recorded: size of SGA, time an number of attempts.
3. Fibreoptic evaluation of the SGAs anatomical position: complete view of the vocal cords (I), epiglottis visible inside, but not causing obstruction (II), epiglottis visible and obstructing the glottic inlet (III), or glottic structures not identified (IV).
4. Functionality of the gastric drainage channel of the SGAs: passage of a 16 G size tube.
5. Measurement of airway seal pressure (oropharyngeal leak pressure (OLP): at baseline, and at 15, 30 and 60 minutes. The maximum pressure allowed is 40 cm H2O.
6. Ventilatory mechanics and parameters are measured at baseline, and at 15, 30 and 60 minutes.

   Perioperative complications: Hiccup, gastric distension, regurgitation / Aspiration, airway obstruction, laryngospasm, dental, mucosal or tongue injury, hypoxia (SpO2 \< 92%)
7. Removal of the SGAs: Presence of blood - 3 level grading (+/++/+++) Postoperative complications: sore throat, hoarseness, dysphonia, dysphagia, dysphagia: 3-point scale

Eligibility Criteria:
Inclusion Criteria:

* Patients evaluated as eligible for a SGA
* ASA I-III
* Without criteria for difficult airway
* Body Mass Index ≤ 35 kg/m2
* The patient has signed the Informed Consent
* The patient understands his or hers rights and consequences related to this investigation

Exclusion Criteria:

* Planned operation time \> 2 hours
* High risk of regurgitation
* Respiratory tract pathology
* Preoperative sore throat
* Patients with a known or predicted difficult airway
* Patients diagnosed with dementia or any mental handicaps
* Patient who has a guardian.
Dose Study in Healthy Japanese Males Investigating Safety, Pharmacokinetics and Pharmacodynamics of NNC126-0083

This trial is conducted in Europe. The aim of this clinical trial is to investigate the safety, tolerability, pharmacokinetics and pharmacodynamics of a NNC126-0083 in healthy male Japanese subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male subjects with Japanese passport and Japanese born parents
* Body Mass Index (BMI, kg/m2) between 18.0 and 27.0, both inclusive
* Subjects must be in good health according to age

Exclusion Criteria:

* A history or presence of cancer, diabetes, or any clinically significant cardiovascular, respiratory, metabolic, renal, hepatic, gastrointestinal, endocrinological, haematological, dermatological, venereal, neurological, psychiatric diseases or other major diseases
* History of any illnesses or disease that, in the opinion of the Investigator might confound the results of the trial or pose additional risk in administering the trial product to the subject
* Any clinically significant abnormal haematology, biochemistry or urinalysis screening tests, as judged by the Investigator
Glycemia in Diabetic Elders Trial

This study is a pilot randomized controlled trial of 30 elderly type 2 diabetes patients conducted at the MODEL Clinical Research (MODEL), Research Division of Bay West Endocrinology Associates in Baltimore, Maryland. The investigators hypothesized that compared to a regimen base solely on traditional drugs, a regimen including newer drugs will achieve glycemic target faster and induce less hypoglycemia, weight gain, and other side effects, over the short run.


Eligibility Criteria:
Inclusion Criteria:

* Type 2 diabetics diagnosed for at least 6 months
* Patients ages ≥ 65 years and older
* Active patients in the Bay West Endocrinology practice
* Inadequately controlled on oral agents and/or basal insulin with HbA1c between 8.0% and 12%
* Eligible for randomization to either treatment group
* Patients willing to follow either treatment arm including regimen using one or more injectables
* Patients to have an English Reading Level of Grade 6 or above
* Patients residing at home

Exclusion Criteria:

* Unwilling to use a regimen that may contain using one or more injections
* Using short acting insulin prior to the study
* Using GLP-1 in past 10 weeks
* History of hypoglycemia unawareness or episodes needing emergency intervention
* End-stage renal disease
* Dementia
* Blindness
* Terminal illness
The Effect of Different Macronutrients on Gastrointestinal Hormone Secretion After Gastric Bypass Operation

The purpose of this study is to determine the type of macronutrient (carbohydrate, lipid or protein) that most potently stimulates the endogen secretion of different gut hormones (primary outcome = Glucagon-Like peptide-1) in gastric bypass operated patients. The study also includes a comparison of the secretion of gut hormones after oral intake of lipid with or without a pancreatic lipase inhibitor.


Eligibility Criteria:
RYGB Patients:

Inclusion Criteria:

* Underwent RYGB surgery more than 18 months earlier, weight stabile (+/- 5 kg during 1 month)

Exclusion Criteria:

* Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior to RYGB operation. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.

Healthy control subjects:

Inclusion Criteria:

* Have not underwent bariatric surgery.

Exclusion Criteria:

* Inadequate thyroid substitution, undergoing treatment with drugs known to interact with Orlistat (such as cyclosporine, anticoagulating agents, amiodarone, amlodipine and epileptics), where pausing the treatment with these is not an option. Type 1 or 2 diabetes mellitus now or prior. Serious heart or respiratory illness. Haemoglobin levels below 6,5 mM.
Nasal Specimen Collection Study in Patients With ILI and/or ARI in an Outpatient Setting

This is a prospective specimen collection study targeting patients presenting with Influenza Like Illness (ILI) and/or Acute Respiratory Infection (ARI) in an out-patient setting. A non-invasive, user friendly sampling technique, using midturbinate flocked swabs will be used. These nasal swabs will be collected in different volumes of viral transport media (0.5mL and 3.0mL), for different dilution range of the viruses present in the collected biological specimen. The collection of nasal swabs samples will support the optimization of point of care detection methods for respiratory viruses responsible for ILI and/or ARI.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female
* All Ages
* Valid Informed Consent and/or Assent, where applicable
* Onset of ILI and/or ARI within the last 3 days (≤ 72h)
* Patient presented with ILI and/or ARI

Exclusion Criteria:

* Invalid Informed Consent and/or Assent
* Onset of ILI and/or ARI was \> 3 days (\> 72 h)
* Patient did not presented with neither ILI or ARI
* Patient received intranasal attenuated influenza virus in last 3 weeks (example FluMist®, Fluenz®)
* Patient received treatment with influenza direct antivirals in the last 7 days
A Study of the Effect of Memantine on Pharmacokinetics, Safety and Tolerability of Single Dose RO5313534 in Healthy Volunteers, and the Effect of RO5313534 on Safety and Tolerability of Steady State Memantine

This open-label, fixed sequence, two-period study will assess the effect of memantine on the pharmacokinetics, safety and tolerability of a single oral dose of RO5313534 and the effect of RO5313534 on safety and tolerability of steady-state memantine. Healthy volunteers will receive a single oral dose of RO5313534 on Day 1 of Treatment Period 1 (3 days). After a washout period of 5-21 days, oral memantine will be administered on Days 1-21 of Treatment Period 2 and a single dose of RO5313534 on Day 19. There will be a follow-up of 3-4 weeks after the last dose. Anticipated time on study for each volunteer is up to 14 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males and females, 18 to 45 years of age inclusive
* Body mass index (BMI) 18-30 kg/m2
* Male subjects must agree to use a barrier method of contraception from first dosing until the end of the study
* Female subjects must be either surgically sterile or agree to use two forms of contraception until the end of the study
* Non-smoker for at least 6 months

Exclusion Criteria:

* Clinically significant history or detection during medical interview/physical examiation of any disease or condition that is capable of altering the absorption. metabolism or elimination of drugs, or would constitute a risk factor when taking the study drug
* History of drug addiction or alcohol abuse
* Any confirmed significant allergic reaction to any drug, or multiple allergies in the judgement of the investigator
* Positive serology to hepatitis B or hepatitis C or Human Immunodeficiency Viruses (HIV type 1 and 2) at screening
* Pregnant or lactating women
* Participation in an investigational drug or device study within the last 3 months prior to first dose
Changes in Cardiac Output During Delayed Umbilical Cord Clamping

Recently, the American College of Obstetricians and Gynecologists (ACOG) recommended a delay of 30-60 seconds in umbilical cord clamping for all newborn infants. This delay allows the newborn to receive his/her own blood from the placenta (placental transfusion) which helps their transition in the first hours of life. The purpose of the study is to learn about the amount of blood flow to and from the baby's heart during normal newborn transition


Eligibility Criteria:
Inclusion Criteria:

* Healthy full term infants
* Delivered by vaginal birth
* Estimated gestational age of 37+0to 41+6 weeks corrected gestational age

Exclusion Criteria:

* Multiples
* Known fetal anomalies (including cardiac defects).
* Instrumentation during delivery (forceps or vacuum)
* Non-reducible nuchal cord during delivery.
* Any maternal or neonatal indication requiring immediate cord clamping.
The Phosphodiesterase 4 Inhibitor Roflumilast as an Adjunct to Antidepressants in Major Depressive Disorder Patients

n pre-clinical studies and early-stage clinical trials, PDE4 inhibitors such as rolipram have been shown to enhance memory. They also improve depressive-like behaviors induced by chronic unpredictable mild stress, lipopolysaccharide, or ethanol abstinence . Consequently, it is reasonable to believe that PDE4 is a potential target for treatment of the comorbidity of depression and AD.The aim of the current study is to evaluate the potential adjunct antidepressant effect of the Phosphodiesterase-4 Inhibitor Roflumilast in adult patients with MDD.

Phosphodiesterase-4 (PDE4), an important member of the PDE superfamily, is a key regulator of intracellular cyclic AMP (cAMP) level. As the second messenger, cAMP activates protein kinase A, which phosphorylates the subsequent downstream cAMP-response element binding (CREB) protein. In the central nervous system, this signaling cascade exerts both pre- and post-synaptic effects and is essential for a variety of cellular functions, including neurotransmitter release and neuroprotection. Inhibition of PDE4 prevents cAMP breakdown, which is well recognized as the mechanism by which PDE4 inhibitors can treat impaired memory linked to several brain disorders. In pre-clinical studies and early-stage clinical trials, PDE4 inhibitors such as rolipram have been shown to enhance memory. They also improve depressive-like behaviors induced by chronic unpredictable mild stress, lipopolysaccharide, or ethanol abstinence . Consequently, it is reasonable to believe that PDE4 is a potential target for treatment of the comorbidity of depression and AD.

The aim of the current study is to evaluate the potential adjunct antidepressant effect of Roflumilast in adult patients with MDD. Furthermore, we will assess the relationship between HAM-D score and BDNF as well as their role as a therapeutic targets of MDD.

Eligibility Criteria:
Inclusion Criteria:

• Eighty adult outpatients with the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM-IV) diagnosis of MDD based on a MINI Neuropsychiatric Interview (MINI) (American Psychiatric Association., 2000; Sheehan et al., 1998), without psychotic features and a total 17 item HAM-D score of at least 20 with item 1 (depressed mood) scored 2 or greater were eligible (Hamilton, 1960).

Exclusion Criteria:

* Patients with bipolar I or bipolar II disorder
* Patients with personality disorders
* Patients with eating disorders
* Patients with substance dependence or abuse
* Patients with concurrent active medical condition
* Patients with history of seizures
* Patients with history of receiving Electroconvulsive therapy (ECT)
* Patients with inflammatory disorders
* Patients with allergy or contraindications to the used medications
* Patients with finally pregnant or lactating females
* Cardiovascular disorders
* Severe renal impairment: creatinine clearance of ≤ 25 ml/min
* Moderate or severe hepatic impairment
A Clinical Research of CD19 and CD22 Targeted Prime CAR-T Cell in Relapsed/Refractory B-ALL

This is a single arm study to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cells therapy for patients with relapsed/refractory B -ALL

Although the anti-CD19 CAR-T cell therapies have gained significant results in patients with relapsed and refractory B-cell hematologic malignancies.

There are patients who resisted anti-CD19 CAR-T cells or with CD19 negative relapse. To make further improvement, the investigators launch such a clinical trial using CD19 and CD22 targeted prime CAR-T cells for patients with relapsed and refractory B-ALL to evaluate the efficacy and safety of CD19 and CD22 targeted prime CAR-T cell therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Signed written informed consent
2. Diagnose as Relapsed and Refractory B -ALL, and meet one of the following conditions:

   1. Failed to standard chemotherapy regimens;
   2. Relapse after complete remission, high-risk and / or refractory patients ;
   3. Relapse after hematopoietic stem cell transplantation;
3. For patients with Ph + ALL, the following conditions must be met: those who have received a standard induction chemotherapy regimen and who have not achieved complete remission after TKI treatment or have relapsed after remission (cannot tolerate TKI treatment or have contraindications to TKI treatment or the presence of TKI class) Except for drug resistant patients)
4. Evidence for cell membrane CD19 or CD22 expression
5. All genders ages: 2 to 75 years
6. The expect time of survive is above 3 months;
7. KPS\>60
8. No serious mental disorders ;
9. Left ventricular ejection fraction ≥50%
10. Sufficient hepatic function defined by ALT/AST≤3 x ULN and bilirubin≤2 x ULN;
11. Sufficient renal function defined by creatinine clearance≤2 x ULN;
12. Sufficient pulmonary function defined by indoor oxygen saturation≥92%;
13. With single or venous blood collection standards, and no other cell collection contraindications;
14. Ability and willingness to adhere to the study visit schedule and all protocol requirements.

Exclusion Criteria:

1. Previous history of other malignancy;
2. Presence of uncontrolled active infection;
3. Evidence of disorder that need the treatment by glucocorticoids;
4. Active or chronic GVHD
5. The patients treatment by inhibitor of T cell
6. Pregnant or breasting-feeding women;
7. Any situation that investigators regard not suitable for attending in this study (e.g. HIV , HCVinfection or intravenous drug addiction) or may affect the data analysis.
Vestibular Rehabilitation for Unsteadiness After Intratympanic Gentamicin in Patients With Meniere's Disease

To investigate the efficacy of vestibular rehabilitation treatment on unsteadiness after intratympanic gentamicin in patients with Meniere's disease.

Previous studies have generally focused on the efficacy of VRT for Meniere's disease, with little attention paid to the effect of VRT on MD patients who still have vestibular dysfunction even after intratympanic gentamicin treatment.

The aim of this study is to compare the efficacy of VRT with usual care in MD patients who experience persistence of unsteadiness 1 month after intratympanic gentamicin treatment, in order to understand whether VR has a positive impact on balance maintenance and vertigo control in MD patients.

Eligibility Criteria:
Inclusion Criteria:

1. Adults aged between 18 and 75 years old;
2. Complained of persistent unsteadiness 1 month after intratympanic gentamicin treatment;
3. Be willing to sign the informed consent of the study.

Exclusion Criteria:

1. Conformed to neuromuscular disease;
2. Conformed to severe cervical spine disease;
3. Conformed to congenital inner ear disease (except vestibular migraine(VM))
4. Concurrent manifestation of psychiatric or psychological disorders.
Effectiveness of Point-of-care Lung Ultrasound for the Management of Childhood Lower Respiratory Infections

The goal of this clinical trial is to evaluate the effectiveness of point-of-care lung ultrasound versus chest X-ray for the management of childhood lower respiratory infections in a low-resource setting.

The main question it aims to answer is:

Is point-of-care lung ultrasound as effective as chest X-ray for the management of childhood LRIs in a low-resource setting?

Participants will be assigned to either a point-of-care lung ultrasound group (intervention) or a chest X-ray group (control), to compare the effect on overall case management and various clinical outcomes (time to symptom resolution, rate of antibiotic use, length of stay, treatment costs).

Background:

Lower respiratory infections (LRIs) are the leading causes of mortality in children of low-middle income countries (LMICs) including Nepal; pneumonia being the major killer in under-5 population. Often, the cause of mortality is the delay in diagnosis and treatment, particularly when clinical assessments do not hint toward a diagnosis. In resource-limited settings, routine availability of chest X-ray (CXR) service is a challenge, it can be hazardous to children due to exposure to ionizing radiation. The Point-Of-Care Lung UltraSound (POCLUS) could be an alternative solution for the diagnosis and management of LRIs. Studies have already shown that lung ultrasound has a higher sensitivity and specificity than CXR in diagnosing childhood LRIs, however, none of the studies have yet evaluated its role in overall case management.

Methods:

Prospective, single-center, pragmatic, open-label, randomized, controlled, non-inferiority clinical trial, which will be conducted in the outpatient and emergency departments of a pediatric hospital in Nepal. A total of 616 children with clinical suspicion of LRI and requiring chest imaging will be randomized at 1:1 allocation to the intervention (POCLUS) and control (CXR) arms. Pediatricians will be trained to perform lung ultrasonography in children.

Outcomes:

Primary outcome is the proportion of 'correctly (effectively) managed' cases. Secondary outcomes include the proportion of cases with 'change in diagnosis and management plan due to intervention', time to symptom resolution, rate of antibiotic use, length of stay, and in-hospital costs, compared between intervention and control groups.

Eligibility Criteria:
Inclusion Criteria:

* Children with a suspected lower respiratory infection (LRI) brought to the outpatient or emergency department,
* Requiring chest image for evaluation at baseline.

Exclusion Criteria:

* Children already hospitalized, received antibiotics, or had chest imaging at the hospital;
* Follow-up (treated within the past 4 weeks) or referred cases;
* Critical patients requiring emergency life-saving support including oxygen;
* Children with one or more danger signs (lethargy or loss of consciousness, convulsion, unable to eat or vomiting everything, cyanosis, excess irritability)
A Prospective, Randomized Study of Operative and Nonoperative Treatment for Primary Traumatic Patellar Dislocation

The objective of this prospective, randomized cohort study was to evaluate the clinical results between operative and nonoperative treatment of primary patellar dislocation.

There is no consensus about management of acute traumatic primary patellar dislocations in young physically active adults. Acute lateral patellar dislocation is a relatively common injury among young adults. Proper treatment for this condition has been researched for decades. However, there is a lack of prospective randomized studies to evaluate the different treatment options for traumatic primary patellar dislocations. Therefore a prospective, randomized study was designed with the aim to compare the outcome of operative versus nonoperative treatment of primary traumatic patellar dislocations in young adults.

Eligibility Criteria:
Inclusion Criteria:

* An acute primary traumatic patellar dislocation

Exclusion Criteria:

* Previous dislocation or subluxation of the patella
* Pre-existing ipsilateral or contralateral knee pathology
* Previous knee trauma or patellar fracture.