cyrilzakka/clinical-trials huggingface dataset:
H-pylori Infection With Disease Activity in Systemic Lupus Erythematosus and Rheumatoid Arthritis

To find the relation of Helicobacter pylori with disease activity in SLE and RA

H. pylori is a widespread, spiral-shaped, flagellated Gram-negative bacterium usually infects the gastric mucosa.Its seropositivity increases with age as it affects about eighty percent of the middle-aged adults in the developing countries and about twenty-five to fifty percent in the western populations.The relation between infection and autoimmune diseases has been previously investigated. Many Gram-negative bacteria as salmonella, shigella, and chlamydia were confirmed to be associated with the development of reactive arthritis.These bacteria have been found to stimulate the host immune response due to the presence of lipopolysaccharides and other antigenic molecules that can cause inflammation.It has been previously hypothesized that H. pylori can induce such immune host response through many mechanisms as the molecular mimicry and antigenic similarity, disruption of the tolerogenic immune response, and activation of the polyclonal lymphocytes leading ultimately to the imbalance between T regulatory/Th17 cells in addition to the induction of autoantibody production

Eligibility Criteria:
Inclusion Criteria:

1. patients with SLE and RA who were admitted to Rheumatology unit in Internal medicine department, Assuit University Hospital will be enrolled in this study

Exclusion Criteria:

* Any patient or control known to have treatment for H. pylori or taking antibiotic treatment for the previous three months 2- Patients receiving biologic therapy 3-Patients known to have diabetes mellitus, autoimmune thyroid disease or autoimmune hepatitis or any other autoimmune
Cholesterol Metabolism and Lipid Transfer in Diabetes

The diabetic dyslipidemia is one of the most important risk factor in the development of coronary artery disease. The low density lipoprotein (LDL)-like nanoemulsions is being used to study the clearance of cholesteryl ester and free cholesterol from intravascular in patients with advanced coronary artery disease and it was shown a higher removal of free cholesterol and higher deposit in vases of this patients. The aim of this study is to analyze the plasma kinetics of both forms of cholesterol(free ad esterified) in type 2 diabetes patients without a previous history of cardiovascular disease.

Hypercholesterolemia is not typical of type 2 diabetes mellitus dyslipidemia, but alterations in LDL may occur related to atherogenesis.Cholesterol exist in two main forms in organism: free cholesterol and the esterified cholesterol. An artificial model to study this two forms of cholesterol is the use of LDL-like nanoemulsion doubly labeled with 14C-cholesteryl esters and 3H- cholesterol. This nanoemulsion is made without protein and when in the intravascular compartment it is able to acquires apolipoproteins from others lipoproteins, such apos A's, C's and E. This model allowed us to use the nanoemulsion particle as a probe to study the lipoproteins receptor binding and the cholesterol esterification process.

Eligibility Criteria:
Inclusion Criteria:

* without a previous cardiovascular disease
* if arterial hypertension, or in use of antihypertensive drugs- it must be well controled with a systolic Blood pressure level \<130mmHg and diastolic \<85mmHg.
* total cholesterol \< 6 mmol/L
* LDL- cholesterol \<4 mmol/L

Exclusion Criteria:

* use of drugs- statins, fibrates, glucocorticoids, thiazolidinediones
* nephropathy- the presence of microalbuminuria(ratio of microalbuminuria/creatinin \>30 ug/mg) or serum creatinin above 98umol/L in woman and above 115 umol/L in man
* retinopathy
* neuropathy presence of chronic disease: heart failure, chronic obstructive pulmonary disease, inflammatory disease and cancer
A Study to Determine Safety and Tolerability of GMI-1359 in Subjects With HR+ Metastatic Breast Cancer

This trial is being conducted to investigate the safety, tolerability, pharmacokinetics (the effect the body has on the drug), and pharmacodynamics (the effect the drug has on the body) of GMI-1359 when given with standard-of-care treatment to subjects with HR+ metastatic breast cancer.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed HR+ metastatic breast cancer, currently stable or minimally progressive on current endocrine-based therapy.
* Continuing on current endocrine-based therapy with an aromatase inhibitor, selective estrogen receptor degrader, or selective estrogen receptor modulator; and must be medically eligible to remain on this therapy during the treatment period.

Exclusion Criteria:

* Uncontrolled acute life-threatening bacterial, viral, or fungal infection.
* Subjects who are pregnant or breastfeeding
* Concurrent treatment with any cytotoxic chemotherapy agent or other targeted therapies including HER2 targeting therapies
* Currently receiving, or less than 28 days since ending treatment on another investigational drug.
* Clinically significant cardiovascular disease.
* Abnormal liver function.
* Any medical, psychiatric, or other condition which, in the opinion of the investigator, is likely to interfere with trial completion, assessments, or interpretation of trial results, or otherwise would make the subject an inappropriate subject for this trial.
The Effects of High Dose Pancreatic Enzyme Replacement Therapy After Pancreatoduodenectomy

Up to now, the studies concerning nutritional assessment after pancreatic resection were rare. The low-dose pancreatic enzyme treatment after pancreatectomy showed no significant benefit in terms of nutritional status. This study is a multicenter randomized phase IV study by using high-dose Norzyme® (40,000 IU) to evaluate quality of life and nutritional status after pancreaticoduodenectomy.

There are not enough studies evaluating nutritional parameters in patients with pancreatic resection. After pancreatic surgery, there are several ways to improve patient condition in terms of quality of life including nutrition.

In the investigators previous study, pancreatic enzyme supplement through the administration of Norzyme® 25000 IU containing lipase 25000 IU, amylase 22500 IU, and protease 1250 IU after various type of pancreatectomy to improve quality of life and nutritional status failed to prove its effectiveness. After administration of low-dose Norzyme® (25000 IU), some patients showed weight gain, but statistically significant conclusions were not obtained mainly because of various types of pancreatectomy and low supplementary dosage of pancreatic enzyme.

Therefore, the investigators design this study to find out the effect of high-dose Norzyme® (40000 IU) on weight gain, quality of life, stool habit change, and nutritional status in patients with pancreaticoduodenectomy. The investigators will evaluate the effectiveness and adequacy of high-dose pancreatic supplementary treatment through a randomized, placebo-using, single-blinded, and multicenter study.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18 and 75 years
* ECOG performance status : 0,1,2
* Patients who underwent pancreaticoduodenectomy or pylorus preserving pancreaticoduodenectomy
* stool elastase ≤200, preoperatively and postoperatively
* Patients consented to this study

Exclusion Criteria:

* Patients with comorbidities such as liver cirrhosis, chronic renal failure, heart failure, and inflammatory bowel disease which can affect the assessment of quality of life or nutritional status
* Patients underwent major abdominal organ surgery such as gastrectomy and colon resection which can affect the assessment of quality of life or nutritional status
* Patients with locoregional recurrence or distant metastasis
* Patients which were not able to progress diet and medication within 10 days after surgery
* Patients with pork allergy
Flexi Band Resistance Training Versus EMS Exercise in Patients With the Diagnosis of Malignant Diseases

The purpose of this study is to investigate the effects of a 12-week flexi band resistance training program compared to different whole-body electromyostimulation (WB-EMS) exercise programs on muscle strength, body composition (in particular muscle mass), cardiorespiratory fitness, inflammation, and patient-reported subjective outcomes (e.g. quality of life, fatigue, performance status) in patients with malignant disease undergoing curative or palliative anti-cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* malignant disease (solid or hematological cancer): head and neck cancer, colorectal carcinoma, small intestinal cancer, gastric cancer, oesophageal cancer, pancreas carcinoma, liver cell carcinoma, cholangiocarcinoma, lung cancer, breast cancer, cervix cancer, ovarian cancer, prostate cancer, renal cell carcinoma, malignant melanoma, patients with leukaemia and malignant lymphomas or Graft-versus-Host-Disease after bone marrow transplantation
* ongoing or planned curative or palliative anti-cancer therapy
* ECOG-Status 0-2

Exclusion Criteria:

* simultaneous participation in other nutritional or exercise intervention Trials
* bone metastases with high fracture risk
* cardiovascular disease
* use of anabolic medications
* epilepsy
* severe neurological or rheumatic diseases
* skin lesions in the area of electrodes
* energy active metals in body
* pregnancy
* acute vein thrombosis
Clinical Investigation of Wireless Transmission of Invasive Blood Pressure Signal

The purpose of this study is to determine whether wireless transmission of invasive arterial blood pressure signal (by HMW 10 Wireless System) from patient to patient's bedside monitor is feasible, safe and as accurate as conventional cable connection.

The technology for invasive arterial blood pressure measurement in emergency room, operating theater, recovery room and intensive care unit is well established and uses pressure sensor connected via cable to patient's bedside monitor. The wireless sensors result in reduction of wires attached to the patient and may enhance nursing, treatment and transportation of patients in aforementioned setting.

The HMW 10 Wireless System was developed and incorporates wireless transmission of patient's signal. The purpose of the study was to measure the quality of data transmitted through the HMW 10 Wireless System, and to demonstrate that the quality of the data meets the requirements of European Directive 93/42/EEC (Medical Device Directive - MDD) and EN/IEC 60601-1 and EN/IEC 60601-2-34.

Eligibility Criteria:
Inclusion Criteria:

* ICU patients requiring invasive blood pressure monitoring

Exclusion Criteria:

* frequent blood sampling through arterial cannula (more than 3 times a day)
Prevalence of Subclinical Atherosclerosis and Its Associated Factors in Hyperlipidemic Korean Adults With Diabetes

This study is to investigate correlation between Carotid Intima Media Thickness (cIMT) and several factors such as; hs C-reactive protein (CRP), HbA1c, lipid profile in Korean diabetic patients with atherosclerosis. Total 360 patients will be enrolled through 6 sites.

MC MD

Eligibility Criteria:
Inclusion Criteria:

* patients with Diabetic Mellitus
* patients with dyslipidemia

Exclusion Criteria:

* patients who have established cardiovascular disease
* patient using NSAID
Assessment of Candidate Protein Expression in Breast Cancer Specimens

RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer.

PURPOSE: This research study is looking at tumor tissue samples from patients who have undergone surgery for breast cancer.

OBJECTIVES:

* To determine if candidate genes display differential expression between normal and cancer breast tissues.

OUTLINE: Previously collected breast cancer tissue samples (paraffin embedded blocks) and normal adjacent tissue are used for immunohistochemistry studies of expression of candidate genes.

Eligibility Criteria:
Inclusion Criteria:

DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer
* Tissue samples available
* Samples are selected based on presence or absence of tumor receptors, (i.e.; estrogen, progesterone, and HER2 receptors) and grouped into following 4 categories:

  * Estrogen receptor (ER)-positive/progesterone receptor (PR)-positive/HER2-negative
  * ER-positive/PR-positive/ HER2-positive by FISH
  * ER-negative/PR-negative/HER2-positive
  * ER-negative/PR-negative/HER2-negative(triple negative or basal-type cancers)

PATIENT CHARACTERISTICS:

* Menopausal status not specified

PRIOR CONCURRENT THERAPY:

* Not specified

Exclusion Criteria:

* There are no exclusion criteria in this protocol
Application-based Perioperative Management of the Radical Cystectomy Patient

The purpose of this study is to learn whether it is feasible to use the LifeScience Technologies application (LST app) in patients undergoing radical cystectomy with the eventual goal to reduce complications and readmissions to the hospital after surgery.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of recurrent Non-muscle invasive bladder cancer (NMIBC) or Muscle-invasive Bladder Cancer (MIBC) and are candidates for radical cystectomy
* Subjects must have an internet connection and be able and willing to use an applicable device. If patients do not have an applicable device, they must be willing to borrow an iPad from the study team (to be returned at the conclusion of the study).

Exclusion Criteria:

* No internet access
Post Approval Study Investigating Lutonix Drug Coated Balloon for Treatment of Dysfunctional Arteriovenous Fistulae

This prospective, global, multicenter, single arm post-approval study is designed to investigate the clinical use and safety of the Lutonix® 035 AV Drug Coated Balloon (DCB) PTA Catheter in subjects presenting with clinical and hemodynamic abnormalities in native arteriovenous (AV) fistulae located in the upper extremity.

This post-market approval study (PAS) is required by the FDA as a condition of approval for the Lutonix drug coated balloon catheter. It is intended to demonstrate safety and assess the clinical use and outcomes of the LUTONIX Catheter in dysfunctional arteriovenous fistulae (AVF) in a heterogeneous patient population in real world clinical practice.

Eligibility Criteria:
Inclusion Criteria:

1. Male or non-pregnant, non-breastfeeding female ≥18 years of age
2. Subject is willing to provide informed consent, and is willing to comply with the protocol-required follow up visits
3. Target lesion must be a mature arteriovenous fistula located in the arm presenting with any clinical, physiological or hemodynamic abnormalities warranting angiographic imaging as defined in the K/DOQI guidelines
4. Subject has a target lesion that can be treated with available LUTONIX DCB according to the Instructions For Use (IFU)
5. Venous stenosis of an AV fistula in which the target lesion is located from the anastomosis to the axillosubclavian junction, as defined by insertion of the cephalic vein
6. Successful pre-dilation of the target lesion with an uncoated percutaneous transluminal angioplasty (PTA) balloon defined as:

   1. No clinically significant dissection;
   2. No extravasation requiring treatment;
   3. Residual stenosis ≤30% by angiographic measurement;
   4. Ability to completely efface the waist using the pre-dilation balloon.

Exclusion Criteria:

1. Subject is currently participating in an investigational drug, biologic, or device study, or previous enrollment in this study
2. Subject has a non-controllable allergy to contrast
3. Subject has another medical condition that, in the opinion of the Investigator, may confound the data interpretation or is associated with a life expectancy insufficient to allow for completion of subject study procedure and follow up
4. Target lesion is located central to the axillosubclavian junction
5. A thrombosed access or an access with a thrombosis treated ≤7 days before to the index procedure
6. Prior surgical interventions of the access site ≤30 days before the index procedure
7. Target lesion is located within a bare metal or covered stent
Clinical Application of Novel Panels for Early Precision Diagnosis and Relapse Prediction in High-risk Leukemia

Based on the investigator's previous data on risk classification for acute leukemia,the investigators will design a set of panels to detect the gene expression and genomic variants (SNPs, mutation, insertion, deletion and fusion genes, etc), and identify the high-risk subtypes of acute leukemia, such as Ph-like acute lymphoblastic leukemia. Furthermore, the target therapy (Tyrosine Kinase Inhibitors,et.al) will be used to treat the identified patients. In addition, more sensitive minimal residual disease (MRD) detection technology will be designed and used to detect the MRD in patients to early predict the disease relapse.

patient eligibility criteria: newly diagnosed acute leukemia patients with clinical high-risk markers, reflactory and relapsed patients.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnostic acute lymphoblastic leukemia Be willing to start treatment

Exclusion Criteria:

* chronic leukemia
A Study of the Safety and Efficacy of Venetoclax for Participants With Chronic Lymphocytic Leukemia (CLL) Used in Routine Clinical Practice

This observational study will evaluate the safety and effectiveness of Venetoclax used in routine clinical practice for participants diagnosed with chronic lymphocytic leukemia (CLL).


Eligibility Criteria:
Inclusion Criteria:

* Participants diagnosed with chronic lymphocytic leukemia who have been prescribed Venetoclax for the first time according to the approved label
* Participants (and/or legal representative) who voluntarily agree to participate in this study and sign informed consent

Exclusion Criteria:

-Participants with contraindications to venetoclax as listed on the approved local label
Evaluation of Acetabular Perfusion After Ganz Osteotomy by Positron Emission Tomography

The purpose of this study is to examine the blood flow in acetabulum after periacetabular osteotomy by Positron Emission Tomography (PET).

As a consequence of periacetabular osteotomy the blood flow in acetabulum is decreased. After periacetabular osteotomy has been performed there is fine contact between the osteotomised acetabulum and the rest of the pelvis and the potential for healing is good. However, it has not been investigated how much the blood flow in acetabulum is changed after surgery. The blood flow is considered to be vital for how the pelvis heals after surgery. Most likely, the blood flow is important in relation to which degree osteoarthritis can be prevented after periacetabular osteotomy.

It is possible to estimate the blood flow by Positron Emission Tomography of the dysplastic hip joint pre- and postoperatively. In this study the blood flow and fluoride uptake is quantified by Positron emission tomography based on measurements of O-15 water and F-18 fluoride.

Eligibility Criteria:
Inclusion Criteria:

* Patients with radiologically diagnosed hip dysplasia (CE-angle \< 25°).
* Patients with osteoarthritis graded 0, 1 or 2 defined according to Tönnis' classification. Patients with pain from hip
* Age \> 18 years.
* Minimum 110° flexion in hip joint and closed growth zones in the pelvic.
* Informed consent.

Exclusion Criteria:

* Patients with neurological diseases
* Patients with calvé-Legg-Perthes syndrome.
* Patients where an femoral intertrochanteric osteotomy is necessary.
* Patients with medical sequelae after earlier hip surgery.
* Females who are pregnant.
* Patients with metal implants.
Pilot Study to Image the Esophagus Using a SECM Tethered Endoscopic Capsule

The goal of this research is to test the imaging quality of the modified, larger diameter, tethered Spectrally Encoded Confocal Microscopy (SECM) capsule in healthy subjects, subjects with Barrett's Esophagus (BE), and subjects with Gastroesophageal reflux disease (GERD).

36 subjects including 12 healthy volunteers, 12 patients with Barrett's Esophagus and 12 with Gastroesophageal reflux disease will be enrolled and asked to swallow the SECM HITEC Capsule. The subjects will be awake and unsedated.

The capsule is attached to a string like tether which allows the operator to control as well as navigate the capsule as it progresses down the esophagus using natural propulsive force called peristalsis.

As the capsule progresses through the esophagus, multiple images of the esophagus are acquired in real time to be analyzed later.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be 1) a healthy volunteer (18 years or older), or 2) a subject with prior diagnosis of BE (18 years or older), or 3) a subject with prior diagnosis of GERD (18 years or older).
* AND Subject must be able to give informed consent.
* AND Subject must eat no solid foods for 8 hours before the procedure and only clear liquids for 2 hours before the procedure.

Exclusion Criteria:

* Subjects with any history of or known upper gastrointestinal strictures
* OR Subjects with a history of Crohn's disease,
* OR Subjects with difficulty swallow
Intramuscular Injection of Mesenchymal Stem Cell for Treatment of Children With Idiopathic Dilated Cardiomyopathy

The main aim of the study is to determine whether intramuscular injection of umbilical cord mesenchymal stem cells can improve the ventricular function of children with idiopathic dilated cardiomyopathy(IDCM); Secondary end-points will be: 1)To explore the possible mechanism of the improvement of ventricular function in children with IDCM and 2) to evaluate the safety of intramuscular injection of umbilical cord mesenchymal stem cell.

Children with Idiopathic dilated cardiomyopathy class II to III NYHA with ejection fraction over 20% were selected for phase II clinical trial, umbilical cord mesenchymal stem cells were injected into limb muscle and followed for 6 months.

Eligibility Criteria:
Inclusion Criteria:

* Children of both genders with established clinical and echocardiographic diagnosis of dilated cardiomyopathy whose parents accept to participate in the trail.
* They should have symptoms and /or signs of heart failure, despite optimized medical treatment.
* Ejection fraction of left ventricular should be less than 50%, but more than 20%.

Exclusion Criteria:

* associate coronary artery disease.
* any history or suspicion of a toxic , pharmacologic or deposit etiology.
* associated malignant or pre -malignant systemic disease.
* associated hematologic disorder.
* a history of sustained ventricular tachycardia or fibrillation.
* a history of syncope during the previous year, or with an active infectious disease or positive tests to viral disease.