cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Oral Semaglutide in Overweight or Obesity

All the eligible participants after screening will be randomized into two groups (Group 1 and 2) by block randomization (block size of 4 and 6) using computer generated random number. Randomization is performed by the individual not involved in the study.

Participants in both groups will receive individual counselling sessions to help them adhere to a reduced-calorie diet (500-kcal deficit per day relative to the energy expenditure estimated at the time) and increased physical activity (with 150 minutes per week of physical activity, such as walking). Both diet and activity will be recorded daily in a diary or by use of a smartphone application or other tools and were reviewed during counselling sessions. Participants in group 1 also receive oral Semaglutide along with diet and exercise. Treatment will be initiated with the 3 mg once-daily dose. The dose will be increased to 7 mg and then maximum of 14mg per day in 2-4weeks interval based on patient tolerance. Dose escalation schedule will be used to decrease the gastrointestinal side effects. Participants will be assessed for gastrointestinal complaints (nausea, vomiting) during escalation and follow-up. Once the desired dose is achieved, patient will remain at the maximum 14mg daily dose unless a reduction was warranted owing to problems with side effects. In such cases, investigators will reescalate the dose once symptoms are resolved or diminished.The absorption of oral Semaglutide is affected by food and fluid in the stomach, hence patients receiving oral Semaglutide will be instructed to take each tablet with up to 120 mL of water in the morning, in a fasting state, and a minimum of 30 min before the first meal of the day. Counselling will be done by a dietician or a similar qualified healthcare professional every 4th week via visits/phone contacts till the completion of the study. Participants have to physically visit the hospital at the end of 28 weeks for assessment.


Eligibility Criteria:
Inclusion Criteria:

* Consecutive consenting patients of both genders with either a BMI of 30 or greater or a BMI of 27 or greater with one or more treated or untreated weight-related coexisting conditions (i.e., prediabetes, hypertension, dyslipidemia, obstructive sleep apnea, or cardiovascular disease).

Exclusion Criteria:

* • Diabetes mellitus

  * A glycated haemoglobin level of 48 mmol per mole (6.5%) or greater,
  * A history of chronic pancreatitis
  * Acute pancreatitis within 180 days before enrolment
  * Previous surgical obesity treatment
  * Use of antiobesity medication within 90 days before enrolment
  * Pregnancy and planning for pregnancy
  * Known malignancy
A Study of Cusatuzumab Plus Azacitidine in Japanese Participants With Newly Diagnosed Acute Myeloid Leukemia or High-risk Myelodysplastic Syndrome Who Are Not Candidates for Intensive Treatment

The purpose of this study is to determine the recommended Phase 2 dose and evaluate safety profile of cusatuzumab in combination with azacitidine in Japanese participants with treatment naïve acute myeloid leukemia (AML) who are not candidates for intensive treatment.


Eligibility Criteria:
Inclusion Criteria:

* For acute myeloid leukemia (AML) participants: AML according to World Health Organization (WHO) 2016 criteria and fulfilling all of the following criteria:(a) more than or equal to (\>=) 75 years of age, or younger participants who are not eligible for or not willing to receive an intensive treatment (including stem cell transplantation) with curative intent and (b) previously untreated AML (except: emergency leukapheresis, low dose of cytarabine and/or hydroxyurea during the screening phase to control hyperleukocytosis but must be discontinued at least one day prior to start of cusatuzumab \[Part 1\] or azacitidine \[Part 2\]). All trans retinoic acid (ATRA) treatment for presumed acute promyelocytic leukemia (APL) is permitted but must be discontinued at least 1 day prior to the start of cusatuzumab (Part 1) or azacitidine (Part 2)
* For Myelodysplastic Syndrome (MDS) participants (only for Part 2): MDS according to WHO 2016 criteria and fulfilling all of the following criteria: (a) Not eligible for or not willing to receive allogenic stem cell transplantation,(b) very high or high-risk MDS according to Revised International Prognostic Scoring System (IPSS-R) and (c) previously untreated MDS (except: transfusion and/or cytokine therapy including erythropoietin)
* Eastern Cooperative Oncology Group (ECOG) performance status score of 0, 1 or 2
* Must sign an informed consent form (ICF) indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study
* A woman of childbearing potential must have a negative highly sensitive serum (beta human chorionic gonadotropin \[beta hCG\]) or urine pregnancy at screening

Exclusion Criteria:

* Acute promyelocytic leukemia (APL) with t (15;17), or its molecular equivalent promyelocytic leukemia retinoic acid receptor (PML RAR alpha)
* Leukemic involvement or clinical symptoms of leukemic involvement of the central nervous system
* Known allergies, hypersensitivity, or intolerance to cusatuzumab or azacitidine or its excipients (example, mannitol, an excipient of azacitidine)
* Prior treatment with a hypomethylating agent for treatment of AML or MDS
* A diagnosis of other malignancy that requires concurrent nonsurgical treatment
Telestroke for Comprehensive Transient Ischemic Attack Care in Acute Stroke Ready Hospitals

TELECAST-TIA is a prospective single-center study evaluating guideline-based transient ischemic attack (TIA) treatment at an Acute Stroke Ready Hospital (ASRH) pre- and post-initiation of a specialist telestroke inpatient rounding service. TELECAST-TIA will study the following clinical endpoints: diagnostic stroke evaluation, secondary stroke prevention, health screening and evaluation, stroke education, inpatient complications, and stroke recurrence rates. Additional relevant non-clinical data will include patient and provider satisfaction scores, transfer patterns, and a cost analysis.

Telestroke is a validated intervention that improves the triage and emergent treatment of acute stroke, specifically related to the use of intravenous thrombolysis. Effective urgent stroke evaluation and secondary stroke prevention is also essential to decrease the risk of recurrent stroke, however, there have been no studies to date examining the use of telestroke to improve delivery of non-emergent inpatient stroke care per American Heart Association (AHA) guidelines.

Currently, access to stroke specialist expertise is limited resulting in significant disparities in stroke care. Previous publications have identified that patients in rural areas may receive sub-optimal stroke care that does not follow accepted guideline recommendations. Telestroke is a cost-effective mechanism to deliver specialist stroke care to hospitals that do not have in-person stroke consultation available. The aim of TELECAST-TIA is to determine whether specialist telestroke inpatient rounding improves guideline-based TIA treatment when compared to non-specialist transient ischemic attack treatment.

The primary outcome of TELECAST-TIA is a composite score of 3 categories: diagnostic stroke evaluation, secondary stroke prevention, and stroke education. Individual components of the primary outcome were principally derived from AHA stroke guidelines. Additional outcome measures include individual analyses of the components of the primary outcome as well as the complication rate, stroke recurrence rate, transfer rate, patient and provider satisfaction levels, and a cost-analysis. All outcomes will be assessed at 1 year post-implementation, with data accruement starting after a 3-month lead in phase.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 and above
* Patients with the primary diagnosis of transient ischemic attack evaluated at the Fairview Ridges Hospital emergency room
* Clinical diagnosis of transient ischemic attack by the treating stroke neurology service

Exclusion Criteria:

* Patients less than 18 years old
* Patients who leave the hospital against medical advice
* Patients who are felt to have an alternative diagnosis
DIAMANTE - Diseases Infectious Analysis Microflora Antibiotic Effect

To assess the effects of Bacillus clausii (Enterogermina®) on fecal microbial flora (using Polymerase Chain Reaction - Denaturing Gradient Gel Electrophoresis - PCR-DGGE - Method) in antibiotic-treated children with complicated acute otitis media or beta-hemolytic streptococcal pharyngo-tonsillitis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects with persistency of symptoms and requiring antibiotics for bacterial upper respiratory tract infections, i.e. complicated acute otitis media (diagnosed by otoscopic examination) or beta-haemolytic streptococcal pharyngo-tonsillitis (diagnosed by pharyngeal swab and rapid antigen detection test or positive culture);
* Outpatients or patients attending an emergency room for both diagnoses, and inpatients in case of complicated acute otitis media;
* Written informed consent from both parents.

Exclusion Criteria:

* History of clinically significant chronic diseases, or chronic diseases necessitating the use of continuous drug therapies, or of any disease that may interfere with the successful completion or the objectives of the trial;
* Clinical evidence of relevant cardiovascular, respiratory, renal, hepatic, gastrointestinal, hematological, neurological or of any disease that may interfere with the successful completion or the objectives of the trial;
* Use of antibiotics, prebiotics or probiotics (medications or dietetic supplements) in the last 2 weeks prior to study entry;
* Hypersensitivity to the investigational product;
* Subjects enrolled in another trial in the previous three months.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Human Milk Fortifiers and Acid-Base Status

Double-blind randomized controlled trial to investigate the impact of two human milk fortifiers on acid-base status and longitudinal growth and weight gain in preterm infants.

Two different compositions are tested, main difference is in electrolyte composiiton.

Two groups each consisting of 15 infants with a birth weight below 2000g are studied.randomization is startified by three birth weigth classes (\<1000g, 1000-1500g,1500 - 2000g) human milk fortifier is introduced in two steps after oral feeding is achieved. two acid-base status and electrolyte concentrations are measured. when metabolic acidosis, defined as BE \< -6 mmol/l, occurs fortifier feeding is stopped, and after a wash-out period of three days the alternative product is used.again, occurence of metabolic acidosis, need for oral bicarbonate and effect on longitudinal growth an weight gain are registered.

Eligibility Criteria:
Inclusion Criteria:

growing premature infants with a birth weight \< 2000g

Exclusion Criteria:

congenital malformation chromosomal disorders sepsis metabolic disorders need for mechanical ventilation
Full Thickness Macular Hole and Internal Limiting Membrane Peeling Study

A macular hole is a fairly common problem in the retina and is an important cause of loss of central vision. The aim of this study is to determine whether, in patients with a stage 2 or 3 full thickness macular hole (FTMH), peeling a very fine, transparent tissue that covers the surface of the retina, called the internal limiting membrane (ILM) during surgery is superior to non-ILM peeling macular hole surgery. The main outcomes are improvement in vision, achievement of macular hole closure, need for re-operation, health related quality of life (HRQOL) and cost effectiveness.

Idiopathic full-thickness macular hole (FTMH) is an important cause of loss of central vision, usually leading to severe visual impairment. Up to 20% of affected people will develop a FTMH in both eyes. There is uncertainty in the literature and among vitreo-retinal surgeons about the balance of potential benefits and adverse effects of ILM peeling in FTMH surgery for stage 2-3 holes.

FILMS is a randomised controlled trial (RCT) in patients with stage 2-3 FTMH less less than 18 months duration investigating whether ILM peeling improves the anatomical and visual outcome of macular hole surgery and the quality of life of patients with this retinal disease. Cost-effectiveness is also being addressed.

Eligibility Criteria:
Inclusion Criteria:

Idiopathic FTMH of stage 2-3, Duration of hole ≤18 months, Visual acuity equal to or worse than 20/40 in the study eye.

Exclusion Criteria:

Stage 1 or 4 FTMH, Stage 2-3 FTMH of \> 18 months duration, Visual acuity \>20/40 in study eye, FTMH related to high myopia (\>6 dioptres), FTMH related to trauma, any other causes of decreased vision (ie corneal scarring, age-related macular degeneration, diabetic retinopathy, glaucoma if central and/or paracentral absolute visual field defects present), patient unable to understand English, patient unable to give informed consent.
Quercetin PK/PD Study in Healthy Adults and Patients With Hypercoagulable States

The goal of this study is to evaluate how much quercetin or isoquercetin is absorbed after a single dose and evaluate for pharmacokinetic inhibition of protein disulfide isomerase. Pharmacodynamic studies will also be performed in an additional cohort of 10 patients with evidence of antiphospholipid antibodies

To compare the absorption and activity of quercetin or isoquercetin with or without ascorbic acid in healthy adults. Oral chews containing quercetin (500mg) or isoquercetin(500 mg total) with or without ascorbic acid will be given. Pharmacokinetic parameters (AUC, Cmax, Tmax, elimination half-life) will be determined over 24 hours (8 time points). Pharmacodynamic inhibition of protein disulfide isomerase activity will also be assessed.

In addition to healthy subjects, a cohort of 10 individuals with antiphospholipid antibodies will participate. These participants will receive isoquercetin 1000 mg and have pharmacodynamics studies performed at time 0 and 4 hours.

All study drugs will be provided by Quercegen Pharma.

Eligibility Criteria:
Inclusion Criteria

* Subject is willing to participate and provide informed consent
* Subject is considered reliable and capable of adhering to the protocol per the judgment of the Investigator
* Subjects in group D must exhibit good organ reserves (within prior 4 weeks) defined as:

  1. Estimated GFR \>35 (formula),
  2. Platelet count \>65 K/uL,
  3. Hemoglobin \>10.5 grams/dL
  4. Total bilirubin \<2.0 mg/dL
* Minimum age 18 years old
* Body mass index (BMI) between 18 and 35 kg/m2
* For cohort D (antiphospholipid antibodies) a. Subjects in group D must have at least one positive antiphospholipid antibody within the last 8 weeks and/or previous confirmed antibodies (2 or more occasions at least 12 weeks apart) : i. Positive lupus anticoagulant ii. anticardiolipin antibody IgM or IgG (\>40U GPL) iii. anti-β2 Glycoprotein1 antibody titer (\>35 units)

Exclusion Criteria

* Pregnant. If female of child-bearing age, negative urinary pregnancy test prior to dosing of quercetin or isoquercetin
* No history of malabsorptive gastrointestinal disorder
* Currently taking aspirin, NSAIDS, warfarin, low-molecular weight heparin or other anticoagulants (such as direct thrombin inhibitors or factor X inhibitors)

  a. Note: Study subjects taking aspirin or NSAIDS, if treating physician concurs, are permitted to enroll if plan to hold for aspirin 10 days or NSAIDS 24 hours prior to dosing of quercetin/isoquercetin
* Prescribed niacin for hyperlipidemia
* Known HIV
* History of sensitivity or intolerance to flavonoids, niacin or ascorbic acid
* May not have uncontrolled intercurrent illness including, but not limited to ongoing or active infection, hepatitis, symptomatic congestive heart failure, unstable angina pectoris or cardiac arrhythmia
Safety and Efficacy of Rayaldee for Treating Mild to Moderate COVID-19

This is a phase 2, single or multi-center, randomized, double-blind placebo-controlled study to evaluate the safety and efficacy of Rayaldee (CTAP101 Capsules) to treat adult subjects with mild to moderate COVID-19 who test positive for SARS-CoV-2.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female ≥18 years of age
2. Confirmed within the past 3 days to have SARS-CoV-2 infection as evidenced by a positive nasopharyngeal swab test using RT-PCR or any substitutable FDA-authorized diagnostic test
3. Confirmed to have only mild or moderate COVID-19 based on the first of the patient reported scores obtained during screening which meets the criterion a FLU-PRO Plus© score of ≥ 1.5 for each of the chest/respiratory and body/systemic domains, and the absence of clinical signs indicative of more severe disease (eg, oxygen saturation \< 94% on room air or respiration rate \> 30 bpm)
4. Represents on self-assessment that the current COVID-19 symptoms are not consistent with usual health and that they are the same or worse than on the previous day
5. Willing to limit the use of vitamin D therapies or supplements except for normally fortified food products (eg, milk) during the course of the 6-week study
6. Must demonstrate the ability to comply with all study requirements
7. Must be without any disease state or physical condition that might impair evaluation of safety or which, in the investigator's opinion, would interfere with study participation.

Exclusion Criteria:

1. Clinical signs indicative of severe or critical COVID-19 disease (eg, oxygen saturation \< 94% on room air or respiration rate \> 30 bpm)
2. Pregnant or lactating women who are breastfeeding
3. Use of systemic glucocorticoid medications in the last six months
4. Recent history (previous 12 months) of primary hyperparathyroidism, kidney stones, hypercalciuria and/or hypercalcemia
5. History of a chronic granuloma-forming disease (eg, sarcoidosis)
6. History of tuberculosis or histoplasmosis
7. History of chronic liver disease
8. History (previous 12 months) of cardiac event indicative of chronic cardiovascular diseases including congestive heart failure, poorly controlled hypertension and arrhythmias
9. History in the past five years of multiple myeloma or carcinoma of the breast, lung or prostate
10. Any surgical or medical condition which might significantly alter the absorption, distribution, metabolism, or excretion of vitamin D or 25-hydroxyvitamin D (25D) (eg, small bowel resection, history of Crohn's disease or ulcerative colitis)
11. Ongoing treatment with thiazide diuretics
12. History of hyperphosphatemia, hyperuricemia and gout
13. Renal impairment measured as eGFR\< 15 mL/min/1.73m² on serum creatinine in the last three months
14. Serum calcium ≥9.8 mg/dL in the last three months
15. Evidence of existing or impending dehydration
16. Known or suspected to have hypersensitivity to any of the constituents of the study drug
17. Currently participating in, or have participated in, an interventional/investigational study within 30 days prior to study screening.
A Clinical Trial Assessing The Impact Of Inhaled Insulin On Glucose Control In Patients With Type 2 Diabetes Mellitus

To assess the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on 2 or more oral anti-diabetic agents


Eligibility Criteria:
Inclusion Criteria:

* Diabetes mellitus type 2
* Failing two or more oral anti-diabetic agents

Exclusion Criteria:

* Asthma, COPD
* Smoking
A Comparative Study Between Regional Anesthesia in Thoracoscopes and the Conventional General Anesthesia

Video-assisted thoracic surgery (VATS) is usually performed with general anesthesia and single lung ventilation. However, performing thoracic surgery under awake regional anesthesia has several potential advantages including avoidance of airway trauma and ventilator dependence associated with endotracheal intubation, besides promoting enhanced recovery after surgery and shorter mean hospital stay.

The aim of this study is to investigate the feasibility and the effect of Thoracic Epidural Anaesthesia for awake thoracic surgery to speed up recovery in patients as well as avoiding the complications accompanying General Anesthesia with one lung ventilation.

Type of Study: Prospective randomized clinical study. Study Setting: This study will be conducted in Ain Shams University Hospitals..

Study Period: Expected for two years starting from 2019.

Sampling Method: Randomized sampling by a computer generated random numbers table.

Sample Size: 40 patients. Sample size was calculated using PASS 11 program for sample size calculation and according to the (Pompeo et al., 2004) study, the mean PaO2 perioperatively in the awake group = -3±1.5 mmHg and in the second group = -6.5±1.83 mmHg. Sample size of 40 cases per group (total 40) can detect this difference with power 100% and α-error 0.05.

Eligibility Criteria:
Inclusion Criteria:

* ASA less than or equal II.
* The procedure expected to be completed within 2 hours.

Exclusion Criteria:

* Patients with expected difficult airway management.

  * Hemodynamically unstable patients.
  * Persistent cough or high airway secretions.
  * Severe Emphysema or clinical signs of active infectious disease.
  * Hypoxemia (PaO2 \&lt;60 mmHg) or hypercarbia (PCO2 \&gt;50 mmHg)
  * Coagulopathy (INR \&gt;1.5).
  * Obesity (BMI \&gt;30 Kg/m 2 ).
  * Infection at the injection site, allergy to local anesthetics.
  * Neurological disorders: seizures, intracranial mass or brain edema.
Evaluation of Retinal Vascular Density in High Myopia Without Pathological Myopic Maculopathy Using OCTA .

Study aiming to evaluate Macular Vascular Density in High Myopes without pathological myopic maculopathy in outpatient clinic in Sohag teaching hospital using OCTA .

Study Design : This is a cross sectional observational study , of about 50 patients attending ophthalmology outpatient clinic at Sohag Teaching Hospital .

Inclusion criteria :

All myopic patients with axial high myopia (-6 spherical refractive error or more) attending the ophthalmology outpatient clinic .

Exclusion criteria :

The exclusion criteria will include :

* History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
* Previous intraocular surgery or ocular injury .
* Any patient with pathological myopic maculopathy (epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy ) .

Eligibility Criteria:
Inclusion Criteria wil include :

* All myopic patients with axial high myopia (-6 spherical refractive error or more) of different age groups .

Exclusion Criteria will include :

* -History of other any ocular diseases , systemic diseases that may affect the ocular circulation .
* Previous intraocular surgery or ocular injury .
* Any patient with pathological myopic maculopathy as epiretinal membrane, foveoschisis, macular holes, lamellar holes, Lacquers cracks, choroidal neovascularization and retinal atrophy .