cyrilzakka/clinical-trials huggingface dataset:
Cold Knife Versus Monopolar Electrosurgery in Abdominal Incisions

the aim of work is to compare the early postoperative and late term wound complication rates between the scalpel and electrosurgery in patients with benign gynecological conditions undergoing abdominal incisions.

• Study Hypothesis: - Using electrosurgery decrease incision blood loss, decrease postoperative pain, decrease wound time incision, decrease analgesia requirements, doesn't increase wound sepsis.

Type of study: - Randomized controlled trial study (parallel group study with 1:1 randomization) will be conducted at gynecology department of Alzhraa University Hospital of faculty of Medicine for girls - Cairo within 1 year according to sample size. A computer randomization will be generated and held with one of the experimenter, and (n) of black and red card will be used for allocation concealment.

Participants at morning of the operation will be given information about the study aims and written consent will be taken.

Eligibility Criteria:
Inclusion Criteria:

* All patients scheduled for elective gynecological abdominal surgeries for benign diseases
* willing to participate in the study.
* The participants will receive 2 gm cephalosporines preoperative per hospital policy.

Exclusion Criteria:

* History of receiving antibiotics during the preceding 7 days,
* chronic medical illness like diabetes, asthma or tuberculosis,
* patients have anemia,
* surgically scarred tissues,
* Immuno-compromised patients,
* pregnant patients,
* patients with pacemaker device,
* patients on anticoagulants therapy
Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy

Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response and is associated with clinical progression of many diseases. Our aim is to assess influence of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs), rs4588 (C\>A) and rs7041 (G\>T), on baseline clinical parameters and response to interferon based therapy in chronic Hepatitis C patients in Egypt.

Methodology: Genotyping will be performed by RFLP (Restriction Fragment Length Polymorphism) in treatment naïve Hepatitis C patients and healthy controls. Vitamin D levels will be assessed by ELISA. HCV RNA quantification will be performed by PCR to assess therapy outcome.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years and ≤ 60 years, fasting blood sugar less than 115 mg/dl or 20% upper normal limit (140 mg/dl), HBA1C ≤ 7.5% in diabetic patients, normal serum creatinine, normal thyroid stimulating hormone level, negative Hepatitis B surface antigen, hemoglobin ≥ 12g/dl for male or ≥ 11g/dl for female, total leukocytes ≥ 3,500/mm3, ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, presence of HCV RNA by PCR and elevated liver enzymes within the preceding 6 months for patients with F1 fibrosis stage.

Exclusion Criteria:

* hypersensitivity to interferon or ribavirin, decompensated liver cirrhosis (presence of ascites, esophageal varices or hepatic encephalopathy), hepatocellular carcinoma, body mass index\>35 Kg/m2 and vitamin D supplementation.
Breast Cancer With Intraoperative Radiotherapy Followed by Hypofractionated External Beam Radiotherapy

To evaluate cosmetic outcomes after conservative surgery for breast cancer with INTRABEAM followed by hypofractionated external beam radiotherapy

To evaluate cosmetic outcomes following conservative surgery (with or without oncoplastic surgery) for breast cancer with intraoperative radiotherapy (INTRABEAM) followed by hypofractionated external beam radiotherapy

Eligibility Criteria:
Inclusion Criteria:

* Histologically-confirmed diagnosis of invasive breast carcinoma and eligibility for conservative surgery (with or without oncoplastic surgery) and radiotherapy.
* Not pregnant at diagnosis.
* Signed informed consent form.
* Age ≥45 years old.
* Patients candidates to Intrabeam.
* Patients with ≥60 years with the presence of one or more of the following adverse criteria after surgery:
* Tumor size \> 2.5 cm.
* Extensive intraductal carcinoma (≥25%)
* Lymphovascular invasion.
* Involved focal margins (\<2mm) without ampliation surgery.

Exclusion Criteria:

* Presence of distant metastasis.
* Primary chemotherapy.
* Lymph node involvement.
* Negative hormonal receptors.
* Diagnosis of any other infiltrating tumour except for adequately resected squamous or basal cell epitheliomas
* Patients with collagen vascular disease (systemic lupus erythematosus, scleroderma, dermatomyositis).
* Uncontrolled infection.
* Concurrent treatment with other experimental treatments
* Lack of signed informed consent form.
PRION-1: Quinacrine for Human Prion Disease

PRION-1 aims to assess the activity and safety of Quinacrine (Mepacrine hydrochloride) in human prion disease. It also aims to establish an appropriate framework for the clinical assessment of therapeutic options for human prion disease that can be refined or expanded in the future, as new agents become available.

The human prion diseases have been traditionally classified into Creutzfeldt-Jakob disease (CJD), Gerstmann-Sträussler-Scheinker (GSS) disease and kuru. They can alternatively be classified into three causal categories: sporadic, acquired and inherited. The appearance of a new human prion disease, variant CJD (vCJD), in the United Kingdom from 1995 onwards, and the experimental evidence that this is caused by the same prion strain as that causing bovine spongiform encephalopathy (BSE) in cattle, has raised the possibility that a major epidemic of vCJD will occur in the United Kingdom and other countries as a result of dietary or other exposure to BSE prions. These concerns have led to intensified efforts to develop therapeutic interventions.

Quinacrine has been previously used to treat other diseases such as malaria; however, it was found to have serious side effects and is no longer licensed in the United Kingdom. There is only very limited evidence from laboratory tests for the potential use of quinacrine in human prion disease, and the evidence to date for any possible clinical benefit is very scarce. The PRION-1 trial is being undertaken since there are no other drugs currently available which are considered suitable for human evaluation.

Eligibility Criteria:
Inclusion Criteria:

* Aged 12 years or more, diagnosed with any type of human prion disease.

Exclusion Criteria:

* In a coma, or in a pre-terminal phase of disease such that prolongation of the current quality of life would not be supported
* Known sensitivity to quinacrine
* Been taking any other putative anti-prion therapy for less than 8 weeks
Comparative Study Between Biodentine and Mineral Trioxide Aggregate in Sealing Root Perforations

This is a study aimed to compare two materials: (1) Biodentine and (2) MTA. These two materials are going to be tested in sealing accidental root perforations at the bifurcation areas. The study is going to be conducted as a randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

1. vital molars (upper or lower )
2. suffered from perforation in the bifurcation area of the roots through a process of open access cavity, taking into account the location and size of perforation
3. Perforation should not exceed the size of 3 mm
4. Perforation and must also take into account the time of perforation.

Exclusion Criteria:

1. If the molar not vital.
2. If the perforation not in bifurcation root or extended inside the canals.
3. Size of perforation larger than 3 mm.
4. A long time ago on the occurrence of perforation with resorption in tooth structure.
Efficacy and Safety of Edoxaban in Patients With Atrial Fibrillation and Mitral Stenosis

This study aims to compare the efficacy and safety of the edoxaban and the warfarin in atrial fibrillation patients with mitral stenosis.

The study design is a multicenter, randomized, open-label, investigator initiated phase 2 trial. The patients were randomly assigned to Edoxaban or Warfarin groups. Primary outcome was a composite of stroke and systemic arterial thromboembolism. The safety outcome was major bleeding.

Non-vitamin K antagonist oral anticoagulants (NOACs) are generally recommended as 1st line therapy for oral anticoagulant in patients with atrial fibrillation (AF). But, the efficacy and safety of NOAC in AF patients with prosthetic mechanical heart valves or moderate to severe mitral valve stenosis have not been proven, and the guidelines recommend vitamin K antagonist (VKA) administration to those patient groups. This trial aims to compare the efficacy and safety of the edoxaban and the warfarin in AF patients with moderate to severe mitral valve stenosis.

Edoxaban in patients with aTrial fibrillation and MItral Stenosis (ERTEMIS) trial is a multicenter, randomized, open-label, investigator initiated phase 2 trial. The patients were randomly assigned to Edoxaban or Warfarin groups. The primary efficacy outcome is a composite of stroke and systemic arterial thromboembolism. The secondary efficacy outcomes are each component of the primary efficacy outcomes and death from any cause. The safety outcome was major bleeding.

Eligibility Criteria:
* Inclusion criteria

  * 18 \< Age \< 80
  * AF diagnosed by ECG at any time prior to enrollment
  * Moderate or severe mitral valve stenosis diagnosed by echocardiography at any time prior to enrollment
* Exclusion criteria

  * Refusal to consent
  * Transient AF due to reversible cause (Postoperative, ongoing systemic inflammation, thyrotoxicosis)
  * Patients undergoing mechanical valve replacement
  * Coagulopathy
  * Hepatic impairment with significant bleeding risk
  * High bleeding risk due to following disease or condition diagnosed within 1 month prior to randomization

    * GI ulcer or bleeding, Esophageal or gastric varix, Malignancy, Brain or cord injury, Surgery for brain, spinal cord, opthalmic, Intracranial hemorrhage, Arteriovenous malformation, Vascular aneurysms, Brain or spinal vascular disorder
  * Stroke, Systemic arterial thromboembolism, Acute myocardial infarction diagnosed within 14 days prior to randomization
  * End stage kidney disease (CrCL \< 15mL/min) or Dialysis
  * Severe hypertension
  * Alcohol abuse or other psychiatric disease
  * Epidural puncture or anesthesia
  * Pulmonary thromboembolism with hemodynamical instability requiring thrombolysis or thrombectomy
  * Pregnant or lactating women
  * Allergy to edoxaban or warfarin
  * Ongoing need for other anticoagulant or clarithromycin, rifampin)
  * Participants for other trials within 1 month prior to enrollment
  * Other patients to be inappropriate to participate in the trial determined by the investigator
AntiDFS70 Lupus Nephritis

Systemic lupus erythematous (SLE) is a heterogeneous autoimmune disease that involve many different organs and display a variable clinical course. The prevalence of SLE varies across gender, race/ethnicity, and geographic regions. SLE demonstrates a striking female predominance with a peak incidence of disease during the Reproductive years. In adults, the female to male ratio is 10- 15:1(1)( 2)

Clinical features in individual patients can be quite variable and range from mild joint and skin involvement to severe, life-threatening internal organ disease. Constitutional symptoms, rash, mucosal ulcers, inflammatory polyarthritis, photosensitivity, and serositis are the most common clinical features of the disease. (3) (4) Anti-DFS70 antibodie) and their clinical associations remain an immunological paradox. Unlike other antinuclear antibodies , there is a growing body of evidence that anti-DFS70 antibodies, when present in high titers and in isolation (without accompanying other antibodies), are useful to aid in the exclusion of antinuclear antibodies associated rheumatic diseases. (8)

Anti-DFS70 antibodies were not associated with lupus nephritis development in Systemic lupus erythematosus patients but were associated with anti-dsDNA antibodies , proliferative lupus nephritis, and renal activity index . This suggests their potential to serve as a non-histological biomarker for lupus nephritis subclass and activity status. (8)


Eligibility Criteria:
Inclusion Criteria:

1. Patients who fulfill the 2019 American College of Rheumatology/European League against Rheumatism classification criteria of Systemic Lupus Erythematous . (9)
2. Patients who is able to give informed consent to join the study.

   •

   Exclusion Criteria:

   -

   - Any patient with any collagen disease other than systemic lupus erythematous
Assessment of Oral Health Related Quality of Life After Full Mouth Rehabilitation Under GA

To assess Oral health related quality of life (OHRQOL) after full mouth rehabilitation under GA in a group of Egyptian children below 5 years


Eligibility Criteria:
Inclusion Criteria:

* Age range 2 to 5 years .
* Children with untreated early childhood caries .
* Children who will undergo dental treatment under general anesthesia.

Exclusion Criteria:

* Participation in any other concurrent clinical trials.
* The presence of serious medical conditions or a transmissible disease such as malignant disease, hepatitis, AIDS etc.
* Children with special healthcare needs.
* Children whose parents had no home or mobile phone to enable postoperative contact.
* Parent that will not sign the consent.
a PRagmatic Observational Study of Congestion proFILes in patiEnts With Acute Heart Failure

The goal of this observational is to study the prevalence of distinct congestion phenotypes and study their association with response to therapy and outcomes in acute heart failure patients. The main question\[s\] it aims to answer \[is/are\]:

* Primary objective: to study the prevalence of distinct congestion phenotypes
* Other objectives (including):

  * Response to therapy as assessed by

    * Natriuresis after 24 hours
    * Rehospitalization and/or deats after 6 months
  * Length of hospital stay
  * Congestion at discharge
  * Changes in filling pressures over time
  * Relationship between liver stiffness, as assessed with Fibroscan and congestion
  * Substudy: glycosaminoglycan netword and endothial glycocalyx

Participants will undergo several extra study related measurements:

* Assessment of filling pressures with ultrasound
* Ultrasound investigation of the lungs and kidneys
* Fibroscan of the liver
* Sidestream darkfield imaging sublingual
* As part of substudy GLYCO-AHF: skin biopsy to determine glycocalyx, as well as salt and water content.
* As part of substudy PREACH-AHF: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins

Objective: to study the prevalence of distinct congestion phenotypes and investigate their association with response to therapy and outcomes in acute heart failure patients.

Study design: Observational, prospective study

Study population: 270 patients admitted with the primary diagnosis of acute heart failure requiring intravenous loop diuretics.

Main study parameters/endpoints:

To identify distinct congestion phenotypes and study their association with response to therapy and outcomes

Secondary outcomes: total natriuresis after 24 hours, and first occurrence of all-cause mortality or heart failure rehospitalisation at 6 months Exploratory outcomes include: length of hospital stay, congestion at discharge and changes in filling pressures over time. Furthermore, as part of the GLYCO-AHF substudy: the expression of glycosaminoglycans and, as part of the PREACH-AHF substudy: the effects of peripheral venous congestion and endothelial dysfunction on a large screen of plasma proteins.

Eligibility Criteria:
Inclusion Criteria:

* Able and willing to give written informed consent
* Age ≥ 18 years
* Male or female
* Primary diagnosis of acute heart failure at presentation, with signs and symptoms of tissue decongestion. Diagnosis is based on the criteria in the ESC HF guidelines (1)
* Requirement of intravenous loop diuretics

Exclusion Criteria:

* Patients with severe kidney dysfunction (in need for ultrafiltration or dialysis)
* Previous participation in this study
* Inability to follow instructions
* Dyspnoea or oedema primarily due to non-cardiac causes
Computerized Cognitive Training in Young Adults With Depression

The purpose of the study is to examine the benefits and mechanism of action of computerized cognitive training (CCT) on mood, neuropsychological deficits, everyday functioning, and brain activity among young adults with a range of depressive symptoms.


Eligibility Criteria:
Inclusion Criteria:

1. Age 18-29.
2. Current diagnosis of MDD/persistent depressive disorder or HDRS greater than or equal to 12. 3. Daily access to smartphone or tablet with internet connection for the study duration.

4. Willing and able to complete MRI, mood, and neuropsychological testing. 5. IQ \> 85.

Exclusion Criteria:

1. Lacks English-speaking ability as determined by self-report and clinical evaluation.
2. Evidence of schizophrenia, schizoaffective disorder, psychosis, bipolar I and II disorder.
3. Active suicidal ideation, intent, or plan, or past attempt within 1 year.
4. Severe depression (HDRS \> 30).
5. Neurological disorder (epilepsy, multiple sclerosis, traumatic brain injury, clinical stroke).
6. Use of medications known to have negative impact on cognition (benzodiazepines and lorazepam equivalents \> 1mg daily, narcotics, anticholinergics).
7. History of alcohol or drug abuse or dependence within past year.
8. Acute, severe, unstable medical illness. For cancer, acutely ill patients (including those with metastases) are excluded, but past history of successfully treated cancer does not result in exclusion.
9. Regular online brain training or regular player of non-fluency verbal games, defined as doing these procedures at a frequency of twice weekly or greater during the year prior to screening.
PreventIon of IMT Progression in iSchemic Stroke Patients With High Risk of Cerebral HemOrrhage-IMT Study

Through this study, the investigators are to prove that Cilostazol effectively prevent progression of intima-medial thickness in ischemic stroke patients with high risk of cerebral hemorrhage, along with no significant increase in the risk of occurrence of hemorrhagic side effects.

The primary hypothesis of this study is; Cilostazol alone or with probucol will reduce the progression of intima-medial thickness compared to aspirin in the ischemic stroke patients with symptomatic or asymptomatic old cerebral hemorrhage.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of ischemic stroke within 120 days
* Adult aged 20 years or older
* High risk of hemorrhagic stroke (history of intracranial hemorrhage or imaging evidence of previous intracranial hemorrhage)
* Informed consent

Exclusion Criteria:

* Clinical diagnosis of myocardial infarction or coronary intervention within 4 weeks
* Bleeding tendency
* Pregnant or breast-feeding woman
* Hemorrhagic stroke within 6 months
* Patient who was taking antithrombotic medication other than aspirin and does not agree to change the previous medication
* Severe cardiovascular disease such as cardiomyopathy or congestive heart failure
* Life expectancy less than one year
* Contraindication to long term aspirin use
* Enrolled in other clinical trial within 30 days
Steroid and Anticoagulant Therapy in covid19

As COVID-19 has neither standard treatment protocol nor guidelines, there are many treatment protocols foranti-inflammatory corticosteroids and anti-coagulations for severe COVID-19 pneumonia patients. This study aimed to assess the most suitable modality in this high-risk group.

Methods: A prospective, experimental study design was adopted, that included 123 severe COVID-19 pneumonia patientsadmitted at Assiut UniversityHospital from April 10th, 2020, to September10th, 2020. Patients were divided into 3 groups according to a combined corticosteroid and anticoagulants therapy protocols. Group A included 32 patients, group B included 45 patients, and group C included 46 patients. Assessment of cases was conducted according to the treatment type and duration, weaning duration from oxygen therapy, length of hospital and ICU stay, and complications during treatment.Three months follow up after discharge was performed.


Eligibility Criteria:
Inclusion Criteria:

* respiratory distress \[respiratory rate (RR) \>30 breaths/min at rest\], mean oxygen saturation ≤93%,ratio of arterial oxygen partial pressure to fractional inspired oxygen (PaO2/FiO2) ≤300 mmHg,\>50% lung involvement on imaging within 24 to 48 hours of admission

Exclusion Criteria:

* pnumonia not caused by covid19
Mucosal Gene Expression Defects in IBD

This study investigated the mucosal gene expression defects associated with active Crohn's disease (CD)and ulcerative colitis (UC), and studied the effect of infliximab induced downregulation of inflammation and mucosal healing on these abnormalities, using whole genome gene expression microarrays.

Infliximab, a monoclonal IgG1 antibody to the pro-inflammatory cytokine tumor necrosis factor-alpha (TNF-α), was the first efficacious biological therapy for IBD. Infliximab dramatically improved the quality of life in IBD patients. Besides inducing and maintaining remission in refractory IBD patients, infliximab has achieved new treatment goals such as intestinal mucosal healing and a reduction in hospitalizations and surgeries on the long-term. However, up to 30% of IBD patients do not respond to this costly therapy and potentially harmful therapy, and in an extra 20-30% response is incomplete. The mechanism of resistance to infliximab is unknown and predictors of response to infliximab are currently lacking.

The aim of this study was to investigate the mucosal gene expression defects associated with active Crohn's disease (CD)and ulcerative colitis (UC), and to study the effect of infliximab induced downregulation of inflammation and mucosal healing on these abnormalities, using whole genome gene expression microarray technology on endoscopic-derived intestinal mucosal biopsies from control individuals and patients with active IBD, and this before and after their first infliximab treatment.

Sixty-one patients with inflammatory bowel disease, 19 with Crohn's colitis, 18 with Crohn's ileitis and 24 with UC, undergo a colonoscopy with biopsies before and 4-6 weeks after the first infliximab treatment. Response to infliximab was defined based on endoscopic and histologic findings. A control group of 12 individuals was also included.Total RNA was isolated from biopsies, labelled and hybridized to Affymetrix HGU133plus2.0 Array. Microarray data were analyzed using Bioconductor software and Ingenuity Pathway Analysis software. Quantitative real time RT-PCR and immunohistochemistry were used to confirm microarray data.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of inflammatory bowel disease (Crohn's disease or ulcerative colitis)
* Patients with inflammatory bowel disease refractory to corticosteroids and/or immunosuppression who had never been treated with biological therapy (anti-TNF treatment).

Exclusion Criteria:

-