cyrilzakka/clinical-trials huggingface dataset:
Comparative Clinical Study to Evaluate the Efficacy and Safety of Rosuvastatin Vs CoQ10 on Nonalcoholic Steatohepatitis

This study will be a randomized, controlled, parallel study that aims to evaluate the efficacy and safety of Rosuvastatin versus Coenzyme Q10 on nonalcoholic steatohepatitis patients.

* This study will be a randomized, controlled, parallel study.
* It will be conducted on 46 patients diagnosed with NASH
* The patients will be randomized into two groups:

Group 1(n=23): patients will receive Rosuvastatin 20mg/day orally

Group 2(n=23): patients will receive Coenzyme Q10 100 mg/day orally

The patients will be selected from community awareness campaigns about NASH in Alexandria , Egypt . Written informed consent will be obtained from all patients. This study will be approved by the Research Ethics Committee of Tanta University and Alexandria university.

The study duration will be 3 months.

Eligibility Criteria:
Inclusion Criteria:

* Age: ≥ 18 years.
* Gender: Both male and female patients will be included.
* Patients have established diagnosis of NASH (based on liver ultrasonography).

Exclusion Criteria:

* Young ages \<18 years
* Secondary causes of hepatic fat accumulation such as Significant alcohol consumption as defined by an average daily consumption of alcohol greater than 30 g/day in men and greater than 20 g/day in women or Long-term use of a steatogenic medication (e.g., non-Steroidal anti-inflammatory drugs (NSAIDs) amiodarone, methotrexate, tamoxifen, corticosteroids)
* Patients with a known history of viral hepatitis, hemochromatosis, Wilson's disease, autoimmune hepatitis, primary biliary cirrhosis, sclerosing cholangitis, biliary obstruction.
* Patients with inflammatory diseases.
* Subjects using any other lipid-lowering agents, or any supplements known to have antioxidant activity and omega-3 supplementation for at least 3 months before participation in the trial
* Current Pregnancy
* Breastfeeding
* Females On Oral Contraceptive pills
* Patients with renal impairment
* Patients with heart failure
* Patients with cancer or with a history of cancer treatment
* Any contraindications to coenzyme Q 10 Or statins like hypersensitivity to anyone
* Patients with predisposing risk factors for myopathy/rhabdomyolysis.
BR55 in Prostate Cancer: an Exploratory Clinical Trial

The purpose of this study is to determine whether BR55 is able to identify areas of VEGFR2 expression in human prostate by ultrasound molecular imaging.

This will be compared with histopathology analysis (location based on expression of VEGFR2 in tissue specimens determined by immuno-histochemistry, IHC).


Eligibility Criteria:
Inclusion Criteria:

* Male patient, age ≥ 40 years old
* Has a histology proven focal prostate cancer lesion
* The patient is already scheduled for prostatectomy not earlier than 3 days and at the latest 15 days after BR55 administration
* Provides written Informed Consent and is willing to comply with protocol requirement

Exclusion Criteria:

* Has a body weight greater than 95 kg (this weight limitation is required in order to maintain the active component of the drug under 100μg) according to the indication of the EMEA guideline M3 for this type of study
* Has documented acute prostatitis or urinary tract infections
* Is known to suffer from stable angina pectoris and/or proven coronary disease, or to have symptoms suspicious of coronary disease
* With history of any clinically unstable cardiac condition including class III/IV cardiac failure or right-to-left shunts
* Has had severe cardiac rhythm disorders within the last 7 days
* Has severe pulmonary hypertension (pulmonary artery pressure \>90 mmHg) or uncontrolled systemic hypertension or respiratory distress syndrome
* Has received a prostate biopsy procedure within 30 days before admission into this study
* Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study.
* Is determined by the Investigator that the patient is clinically unsuitable for the study.
* Is incapable of understanding the language in which the information for the patient is given
* Participation in a concurrent clinical trial or in another trial with an investigational compound within the past 30 days;
Non-contact DCS-Speckle Multi-parameter Imaging for Neurological Diseases

This study aims to evaluate brain injuries and brain edema with non-contact DCS-Speckle multi-parameter imager.

Brain injuries includes acute and chronic injuries located in cerebral hemispheres, cerebellum, and brain stem, while brain edema is increased intracellular or extracellular fluid in brain tissue. Early diagnosis is helpful to improve the cure rate and reduce sequelae. This study aims to evaluate brain injuries and brain edema with non-contact DCS-Speckle multi-parameter imager, so as to provide reference diagnostic criteria by image artificial intelligence analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have had brain damage.
* Patients who have had brain edema.
* Healthy people who are interested in non-contact DCS-Speckle multi-parameter imaging

Exclusion Criteria:

* Patients who are in pregnancy or have plan to conception.
* Patients who have vertebra surgery or have plan to surgery.
* Patients who are inappropriate to join this trial judged by the radiologists or specialists.
* AIDS, Active Hepatitis, Tuberculosis, Syphilis
* Patients who regularly take anticoagulants, antiplatelet drugs
TACE With or Without SBRT as Bridging Therapy for Pre-transplant HCC Patients

This trial is designed to be the initial prospective pilot investigation of the effectiveness of combined SBRT and TACE as bridging therapy for HCC patients awaiting liver transplanation. No prospective clinical trials regarding the combination of TACE and SBRT in pre-transplant population have been performed. We propose the trial be conducted as a pilot clinical trial with the goal of enrolling 40 patients into each arm

The purpose of this study is to determine whether the combination of stereotatic body radiotherapy (SBRT) tand transarterial chemoembolization (TACE) is an effective "bridging therapy" for patients hepatocellular carcinoma (HCC) of the liver awaiting transplantation.

Eligibility Criteria:
Inclusion Criteria:

* Patient capable of giving informed consent
* Patient diagnosed with hepatocellular carcinoma and listed or recommended to be listed for orthotopic liver transplantation at the participating institution
* Age \> 18 years old
* Meets clinical criteria for eligibility for TACE to the target lesion per Interventional Radiology
* Childs' Class A or B7
* Eastern Clinical Oncology Group performance status 0 or 1

Exclusion Criteria:

* Prior radiotherapy to the upper abdomen or radioembolization of the liver
* Prior TACE to the target lesion, RFA, or liver transplant
* Active GI bleed within 2 weeks of study enrollment
* Active GI ulcer disease within 4 weeks of study enrollment
* Ascites refractory to medical therapy
* Contraindication to receiving radiotherapy or TACE
* Complete obstruction of portal venous flow to the segment of liver that includes the target lesion
* Contraindication to both contrast enhanced MRI and contrast enhanced CT (i.e. unable to undergo follow-up imaging or SBRT treatment planning)
* Women who are pregnant
* Participation in another concurrent treatment protocol
Short-term Functional Recovery Between Early- and Late Bisphosphonate Treatment Following Hemiarthroplasty

Femoral neck fracture in the elderly is one indication for initiating osteoporosis treatment. Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons concern regarding their effects on fracture healing process. Therefore, therapy is usually delayed for a period of time. To the best of our knowledge, there is no scientific data to support whether bisphosphonate treatment should be given immediately after the surgery or it should be delayed.

Femoral neck fracture in the elderly is one indication for initiating osteoporosis treatment. Bisphosphonates remain the first line therapy; however, many orthopaedic surgeons concern regarding their effects on fracture healing process. Therefore, therapy is usually delayed for a period of time. To the best of our knowledge, there is no scientific data to support whether bisphosphonate treatment should be given immediately after the surgery or it should be delayed.

This study aims to compare functional recovery between early- and late administration of bisphosphonate in patients who received hemiarthroplasty following femoral neck fractures.

Eligibility Criteria:
Inclusion Criteria:

* Patient diagnosed with femoral neck fracture and was treated with bipolar hemiarthroplasty
* Age more than 50 years old and bone mineral density (BMD) was in osteoporotic (T-score less than -2.5) or osteopenic (T-score between -1.0 and -2.5) ranges

Exclusion Criteria:

* Patients who were treated with bipolar hemiarthroplasty for more than 2 weeks
* Patients with postoperative complications which affect the postoperative rehabilitation program e.g. intraoperative cracking or fracture, postoperative cardiac complication
* Have contraindications for bisphosphonates use e.g. renal insufficiency (glomerular filtration rate (GFR) \< 30 ml/min), allergy to bisphosphonates, severe esophagitis, gastroesophageal reflux disease etc.
* Patients with conditions/disorders which have an affect on bone mineral density or bone metabolism e.g. renal insufficiency, rheumatoid arthritis, Paget's disease, renal osteodystrophy, hyperparathyroidism, glucocorticoids use etc.
* History of bisphosphonates use within 12 months
* Open fracture, multiple fracture or multiple trauma patients
* Pathological fracture
* Bilateral lower extremity fractures
* The pre-injury functional status of the patients is non-ambulatory
Study of Assisted Hatching of Cleavage Stage Embryos

The purpose of this study was to determine if assisted embryo hatching can improve pregnancy rates for good prognosis patients undergoing in vitro fertilization (IVF) with day 3 embryo transfer.

Assisted hatching is a procedure in which a hole is made in the hard covering of a developing embryo to allow the embryo to hatch more easily from this shell. This procedure is sometimes used before transferring embryos to patients after in vitro fertilization (IVF) in an attempt to improve resulting pregnancy rates. Assisted hatching has been shown to improve outcomes among certain groups of patients, such as older patients or patients with a history of IVF treatment and embryo transfer without success. Whether this procedure could benefit the broader patient population remains unclear. The purpose of this study was to evaluate potential benefits of assisted hatching for good prognosis patients who would not typically be treated with assisted hatching under current standard protocols. Pregnancy rates were compared between good prognosis patients undergoing IVF with day-3 embryo transfer with or without assisted hatching of the transferred embryos.

Eligibility Criteria:
Inclusion Criteria:

* IVF patients with day 3 embryo transfer
* Maximum age of 39 years
* Maximum FSH 9 mIU/ml
* Maximum E2 75 pg/ml
* Ovulatory menstrual cycles
* Good embryo quality

Exclusion Criteria:

* Diagnosis of diminished ovarian reserve, polycystic ovarian syndrome, uterine or egg factor infertility
* More than one previous unsuccessful IVF cycle
Effect of Oral GS-6615 on Dofetilide-Induced QT Prolongation, Safety, and Tolerability in Healthy Adults

This study will evaluate the effect of oral GS-6615 on QTc interval in healthy adults with dofetilide-induced QTc prolongation.


Eligibility Criteria:
Inclusion Criteria:

* Must, in the opinion of the investigator, be in good health based upon medical history and physical examination, including vital signs
* Have a calculated body mass index (BMI) from 18 to 30 kg/m\^2, inclusive, at study screening
* Have either a normal 12-lead electrocardiogram (ECG) or one with abnormalities that are considered clinically insignificant and which do not interfere with the ability to interpret the QT interval in the opinion of the investigator in consultation with the medical monitor

Exclusion Criteria:

* History of meningitis or encephalitis, epilepsy, seizures (known or suspected), migraines, tremors, myoclonic jerks, sleep disorder, anxiety, syncope, head injuries, or a family history of seizures
* Have any serious or active medical or psychiatric illness (including depression) which, in the opinion of the investigator, would interfere with treatment, assessment, or compliance with the protocol. This would include renal, cardiac, hematological, hepatic, pulmonary (including chronic asthma), endocrine (including diabetes), central nervous, gastrointestinal (including an ulcer), vascular, metabolic (thyroid disorders, adrenal disease), immunodeficiency disorders, active infection, or malignancy that are clinically significant or requiring treatment.
* Presence or history of cardiovascular disease, including structural heart disease, myocardial infarction (by ECG and/or clinical history), history of ventricular tachycardia or torsade de pointes, heart failure or cardiomyopathy (by clinical history and/or left ventricular ejection fraction \< 40%), presence of cardiac conduction abnormalities, a family history of Long QT or Brugada Syndrome, or unexplained death in an otherwise healthy individual between the ages of 1 and 30 years
* Additional cardiovascular-specific exclusion criteria include findings on screening ECG of:

  * QTcF interval \> 430 msec
  * PR interval \> 220 msec
  * QRS duration \> 110 msec
  * Second- or third-degree atrioventricular block
  * Complete left or right bundle branch block or incomplete right bundle branch block
  * Resting heart rate \< 40 or \> 100 beats per minute (bpm)
  * Pathological Q waves (defined as Q wave \> 40 msec)
  * Ventricular pre-excitation
  * More than 2 ectopic beats
* Syncope, palpitations, or unexplained dizziness
Specificity Study of Diagnostic for Early Detection of Dengue Infection

This study assesses the specificity of DENV Detect™ NS1 ELISA versus standard reference tests (e.g. PCR or viral culture) for dengue diagnosis in the US.

DENV Detect™ NS1 ELISA serves as an aid in the clinical laboratory diagnosis of early stages of Dengue infection in patients with clinical symptoms consistent with Dengue infection. This test is intended to be used on sera obtained within the first 7 days of symptoms. DENV Detect™ NS1 ELISA and rapid test results (positive or negative) must be confirmed by testing with a reference standard test.

This study will use archived, leftover human serum samples that have been sequentially collected from areas non-endemic for Dengue infection. Each specimen must have been collected within the first 7 days of symptoms, and must be accompanied by clinical data demonstrating that the individual had symptoms consistent with Dengue infection. The samples will have no personally identifiable information.

ELISAs and reference tests will be performed by different operators who are laboratory staff members. These staff members, blinded to each other's results, will evaluate the samples from each method independently.


Eligibility Criteria:
Inclusion Criteria:

* All age groups and both sexes.
* Serum samples collected within 1- 7 days of onset of symptoms consistent with Dengue virus infection.
* Information must be available about symptoms, age, and sex of patients from which samples are collected.

Exclusion Criteria:

* Any sample(s) with linked personal identifiers or any sample for which personal information can be discovered will be excluded.
An Observational Study of Stroke Patients.

The intention is to study presumed changes in daily practice, probably due to New Guidelines concerning stroke patients. The impression is more frequent measurements of blood pressure, serum glucose, troponin and supplementary computer tomography or magnetic resonance imaging.

There is in general a focus on misuse of health resources. An increasing amount of guidelines is produced to reduce the variation in treatment of patients with the same diagnosis. Many recommendations are weak but seems though to have considerable impact on in hospital care. The issues to be studied are all grounded on weak clinical evidence. A pilot study confirmed the suspicion of very frequent measurements of blood pressure, glucose, troponin and frequent supplementary CT and MRI. The intention is to study these issues in a larger population including an evaluation of utility of the different examinations and evaluations.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a diagnosis of stroke according to ICD 10th revision (code I61 I63 and I64)
* Hospitalized between January 1 and December 31, 2015

Exclusion Criteria:

* Previous hospitalization with a diagnosis of stroke in 2015.
* Foreigners and patients from other regions of Norway.
Percutaneous Tracheostomy With COVID-19

Coronavirus disease 2019 (COVID-19) has brought about a requirement of intensive care and mechanical ventilation for a significant portion of patients. Percutaneous tracheostomy is performed in order to reduce the complications that may develop due to prolonged endotracheal intubation.

Different methods are needed for situations in which the potential for producing aerosols is high, such as intubation and tracheostomy. One of these methods is the aerosol box.To share our experiences of percutaneous tracheostomy performed with aerosol box in COVID-19 patients. Patients who underwent percutaneous tracheostomy between March 2020 and June 2020 in the pandemic intensive care unit were evaluated retrospectively.The study is designed as a clinical trial study. This study was performed in faculty of medicine hospital's intensive care unit which is located in Canakkale province Turkey.

Eligibility Criteria:
Inclusion Criteria:

* who underwent percutaneous tracheostomy with COVID-19(+)

Exclusion Criteria:

* Patients who do not give informed consent or do not want to participate in the study
* Coagulopathy, thrombocytopenia
Patient-ventilator Asynchrony in Patients With Brain Injury

Mechanical ventilation is an important support strategy for critically ill patients. It could improve gas exchange, reduce the work of breathing, and improve patient comfort. However, patient-ventilator asynchrony, which defined as a mismatch between the patient and ventilator may obfuscate these goals. Studies have shown that a high incidence of asynchrony (asynchrony index \> 10%) is associated with prolonged mechanical ventilation and ICU length of stay and high mortality. So far, there have been only a few studies on the epidemiology of asynchrony in brain-injured patients. Investigators conduct a prospective observational study among brain-injured patients to determine the prevalence, risk factors and outcomes of patient-ventilator asynchrony. Esophageal pressure monitoring, a surrogate for pleural pressure, combined with airway pressure and flow waveforms is used to detect patient-ventilator asynchrony.


Eligibility Criteria:
Inclusion Criteria:

* 1) \]older than 18 years 2) with brain injury in the ICU 3) mechanical ventilated for at least 72 hours

Exclusion Criteria:

* 1) ICU length of stay less than 24 hours 2) enrolled in another trial
Impact of Hypothalamic Gliosis on Appetite Regulation and Obesity Risk in Children

BEAM is a multi-site longitudinal cohort study of hypothalamic gliosis, central regulation of appetite and weight gain in children. Participants will be recruited from the community in the greater Seattle and greater Baltimore area. All participants will consent to enroll in the 24-month study during which they will complete 5 in-person study visits.

The proposed 2-site research study uses a longitudinal cohort design in 102 children aged 9-11 yr. It will include for all participants baseline MRI and functional MRI, in-depth eating behavior testing, and measurement of hormone profiles. Serial measurement of weight and self-reported eating habits will occur over 2 yr, with a repeated MRI at 2 yr. The study aims to: 1) test if MBH gliosis is associated with impaired intake regulation and poor weight outcomes over 2 yr in children, 2) determine if CNS appetitive processing is negatively affected when evidence of MBH gliosis is present, and 3) test for other brain regions in which gliosis is present in association with excess adiposity in children. An exploratory aim will assess changes in gliosis in children over 2 yr and their relation to changes in body weight and adiposity.

Eligibility Criteria:
Inclusion Criteria:

* 9-11 y (at time of enrollment)
* BMI ≥ 15th percentile for age and sex

Exclusion Criteria:

* Significant Health conditions (e.g., type 2 diabetes)
* Documented cognitive disorder
* History of major weight loss of 10lbs or more, not due to illness, over the past year
* Eating disorder (e.g. anorexia, bulimia)
* Current use of medications known to alter appetite, body weight or brain response including: Anti-epileptics; Glucocorticoids; Antipsychotics; Stimulants for ADHD
* MRI contraindication (e.g. implanted metal, claustrophobia, inability to fit in MRI scanner)
* Weight \>330 pounds (MRI limit)
* Severe food allergies, vegetarian, or vegan, or unable to eat study foods
* Currently in formal weight loss program
Single and Multiple Ascending Dose Study of CORT113176 in Healthy Participants

This is a 3-part, first-in-human study of single ascending doses (SAD; Part 1) and multiple ascending doses (MAD; Part 2) of CORT113176 in healthy participants; Part 3 is an optional part to investigate whether CORT113176 ameliorates the effects of prednisone on various pharmacodynamic (PD) endpoints. The 3 parts may not be conducted entirely sequentially provided that this is justified by pharmacokinetic (PK) and safety data obtained from completed cohorts. The first MAD cohort will not start until data are available from at least 2 SAD levels to allow MAD administration in the fasted state, or until after a food-effect cohort has been dosed in the SAD phase to allow MAD administration in the fed state. The expected exposure for the daily MAD level at steady state (taking into consideration potential accumulation on repeat dosing) must not exceed the highest exposure considered to be safe and well tolerated during preceding SAD cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Body mass index (BMI) 18.0 to 30.0 kg/m\^2, inclusive
* Body weight ≤102 kg
* Willing to consume a high-fat breakfast, including pork
* Agrees to adhere to the contraception requirements of the protocol
* Additional criteria apply.

Exclusion Criteria:

* Received any investigational drug or device in a clinical research study within the last 90 days
* History of any drug or alcohol abuse in the last 2 years; a confirmed positive drugs of abuse test result
* Regular alcohol consumption; a confirmed positive alcohol breath test at screening
* Current smoker; a confirmed positive breath carbon monoxide reading; current user of e-cigarettes or nicotine replacement products in the last 6 months
* Female of childbearing potential, pregnant or breastfeeding
* Have a pregnant partner
* Clinically significant abnormal clinical chemistry, hematology, or urinalysis result
* Positive for hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (HCV Ab), or human immunodeficiency virus (HIV)
* Active renal or hepatic disease
* History of clinically significant cardiovascular, renal, hepatic, endocrine, metabolic, respiratory, gastrointestinal, neurological, or psychiatric disorder
* Any form of cancer in the last 5 years (exceptions apply)
* History of adrenal insufficiency
* Have a condition that could be aggravated by glucocorticoid and/or mineralocorticoid blockade
* Currently using glucocorticoids or a history of systemic glucocorticoid use in the last 12 months or 3 months for inhaled products
* Additional criteria apply.