cyrilzakka/clinical-trials huggingface dataset:
Effectiveness of the Use of a Mobile Tool in Improving Lifestyles

Objectives: To develop and validate a mobile tool for use in Smartphone supports as a first step, and to evaluate the effect of adding this new tool of information and communication technologies (ICT), to a standardized intervention to increase adherence to nutritional recommendations of the Mediterranean diet and increase physical activity as primary endpoint. Analyze adherence and intervention results from a gender perspective. Methodology: Multicenter, randomized double-blind, clinical trial with two parallel group, aimed at assessing the effects of adding an TIC tool, developed for the Smartphone application (intervention), in support of behavioral and educational recommendations (control) in the increased physical activity and adaptation to the Mediterranean dietary pattern. Population: 1215 included subjects younger than 70 years from the project EVIDENT who agree to participate. Measurement and interventions: Physical activity will be assessed with the accelerometer and the 7-PAR day and adaptation to the Mediterranean diet with a questionnaire of adherence and a food frequency survey. It will also assess vascular structure and function, central blood pressure, Augmentation index, pulse rate and of carotid intima-media thickness. The counsel to adaptation the Mediterranean diet (based on the project PREDIMED) and exercise (based on PEPAF project), will be common to both groups. The intervention group will be added training and use of an application on a Smartphone designed to promote healthy eating and increased physical activity.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects since 20 to 70 years

Exclusion Criteria:

Older than 70 years are excluded, due to difficulties in the use of ICTs and those who can not exercise or follow a diet Mediterranean diet
LOTCOL Study: Local Treatment of Colo-rectal Liver Met

In this study the investigators will include colo-rectal cancer (CRC) patients starting last line of standard palliative chemotherapy. Eligible patients include patients with KRAS mutation starting line or KRAS wild type starting line treatment. Standard treatment today for these patients is chemotherapy only and median overall survival (OS) is about 10 months. The hypothesis is that local treatment in addition to systemic treatment will increase time to progression, progression free survival and overall survival compared to patients who receive systemic chemotherapy only. The investigators experience with local treatment of liver metastases in CRC patients is that side-effects of treatment in general are minor, although gastric bleeding have been observed after stereotactic body radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Histologically verified adenocarcinoma of colon or rectum
* Ambulatory with an ECOG performance status 0-2
* At least 18 years of age
* Non-resectable liver metastases
* Progressive disease on or within 4 months after 1.line chemotherapy for KRAS mutant or after 2.line chemotherapy in KRAS wild type patients
* 1-4 liver metastases with largest diameter of up to 6 cm on CT-scan
* Up to 20 lesions in liver with no more than 4 lesions larger than 4 cm
* The patients will start 2./3. line chemotherapy (KRAS mutant/KRAS wt)
* Laboratory values as the following:

  * ANC ³ 1.5 x 109/L
  * Platelets ³ 100 x 109/L
  * Hb ³ 9g/dL
  * Creatinine £ 2x upper limit of normal
  * Bilirubin \< 2.0x the upper limit of normal
  * ASAT and ALAT £ 5x the upper limit of normal
  * Albumin levels \> 30 g/L
  * INR\<1.3
* Signed informed consent and expected cooperation of the patients for the treatment and follow up must be obtained and documented according to ICH GCP, and national/local regulations

Exclusion Criteria:

* Previous treatment with 2. or 3. line chemotherapy (KRAS mutant/KRAS wt)
* History of prior metastatic disease the last 3 years
* History of CNS or bone metastases
* Significant cardiac or other medical illness that would limit activity or survival, such as severe congestive heart failure, unstable angina, or serious cardiac arrhythmia
* Largest liver mets \>6 cm, more than 4 liver lesions \>4 cm
* Pulmonary mets\>3 cm
* Lymph node mets \>2.5 cm
* Chemotherapy/radiation therapy or major surgery within the last 4 weeks before start of treatment
* Any reason why, in the opinion of the investigator, the patient should not participate.
Post-Authorization Long-Term Safety Study of LUTATHERA

Study to assess the long-term safety of LUTATHERA for the labeled indication (SmPC/USPI).

To assess the incidence and nature of potential long-term safety outcomes in patients with unresectable or metastatic, well-differentiated, somatostatin receptor positive gastroenteropancreatic neuroendocrine tumours. Retrospective and prospective data will be used.

Eligibility Criteria:
Inclusion Criteria:

* adult patients (fulfilling the definition of "age of majority" per local regulations),
* with unresectable or metastatic, well-differentiated, somatostatin receptor positive GEP-NETs
* and who were treated with Lutathera (regardless of the quantity and number of doses administered and whatever the reasons for ending).

Exclusion Criteria:

* Hypersensitivity to Lutathera (active substance or any of the excipients),
* presence of established or suspected pregnancy or pregnancy not excluded,
* presence of kidney failure with creatinine clearance \< 30 mL/min.
Dynamic Characterisation of Meibomian Gland Structure

This will be a single center pilot study to evaluate appearance of the Meibomian glands.


Eligibility Criteria:
Inclusion Criteria:

* Potential subjects must satisfy all of the following criteria to be enrolled in the study:

  1. Healthy adult males and females, 18-40 years of age (inclusive)
  2. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form
  3. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol
  4. The subject must agree not to participate in other clinical research for the duration of this study
  5. The subject's optimal spherical equivalent distance refraction must be between +1.00 and -2.00 D in each eye
  6. The subject's refractive cylinder must be ≤-1.00 DC in each eye
  7. The subject must score less than 4 points (inclusive) in SPEED questionnaire

     Exclusion Criteria:
* Potential subjects who meet any of the following criteria will be excluded from participating in the study:

  1. Currently pregnant or lactating
  2. Any systemic disease (e.g. Sjögren's Syndrome), allergies, infectious disease (e.g. hepatitis, tuberculosis), contagious immunosuppressive diseases (e.g. HIV), autoimmune disease (e.g. rheumatoid arthritis), or other diseases, by self-report, which are known to interfere with contact lens wear and/or participation in the study
  3. Have had cataract surgery
  4. Use of systemic medications (e.g. chronic steroid use) and any current use of ocular medications (e.g. lubricants, artificial tears) that would interfere with participation in the trial, at the Investigator's discretion
  5. They have history (more than one week in total) of contact lens wear.
  6. Any previous, or planned (during the course of the study) ocular surgery (e.g. radial keratotomy, PRK, LASIK, etc.)
  7. Any ocular allergies, infections or other ocular abnormalities that are known to interfere with participation in the study. This may include, but not be limited to entropion, ectropion, extrusions, chalazia, recurrent styes, glaucoma, history of recurrent corneal erosions, aphakia, corneal distortion or keratoconus
  8. History of allergy to sodium fluorescein or lissamine green
  9. Any Grade 1.5 or greater slit lamp findings (e.g. oedema, corneal neovascularization, corneal staining, tarsal abnormalities, conjunctival injection) on the Efron Grading Scales or other ocular abnormality including Meibomian gland dysfunction (MGD) or blepharitis (Grade 1.0 or greater)
  10. Meibomian gland atrophy exceeds 25% (inclusive) in either lower or upper eyelid
  11. The central glands atrophy exceeds 25% (inclusive)
  12. The number of Meibomian glands yielding liquid secretion (MGYLS) is 6 or less (applicable to Phase II subjects only)
  13. Use of eye makeup on the days of the study visits
  14. Participation in any pharmaceutical or medical device related clinical trial within 14 days prior to study enrolment
  15. Employee or immediate family member of an employee of clinical site (e.g. Investigator, Coordinator, Technician)
Assessment of the Diagnostic Role of Serum Insulin-like Growth Factor Binding Protein-3 as a Potential Biomarker for Colorectal Cancer (CRC) in Egypt

1. evaluation of diagnostic importance of insulin like growth factor binding protein3 in patient with recently diagnosed as Colorectal cancer
2. correlation between the diagnostic efficacy of insulin like growth factor binding protein 3 with routine marker carcinoembryonic antigen.

Colorectal Cancer is the third most common cancer diagnosed in the USA and the world's fourth most deadly cancer .the incidence and the mortality rate of colorectal cancer has decreased due to effective cancer screening measures.

Besides an ageing population and dietary habits of high-income countries, unfavourable risk factors such as obesity, lack of physical exercise, and smoking increase the risk of colorectal cancer.

The incidence of early-onset colorectal cancer diagnosed in patients under the age of 50 years- has been increasing around the world.

The insulin-like growth factor (IGF) system composed of two ligands, their receptors and regulatory proteins.

IGFBPs regulate the cell cycle, and the function of IGFBPs in transcriptional regulation, DNA damage repair and apoptosis induction suggest that they are closely associated with tumour development, progression, and therapy resistance.

Insulin-like growth factor peptides play important roles in regulating cell growth, cell differentiation, and apoptosis, and have been demonstrated to promote the development of colorectal cancer.

Researchers found that IGFBP3 has the potential to be used as early indicator for colorectal cancer diagnosis.

Moreover, IGFBP3 as a risk factor for carcinogenesis has been demonstrated in many cancers.

IGFBP3 as a tumour suppressor was reported to be down-regulated in some cancers. But some other publications showed its overexpression is associated with poor prognosis for several cancers including pancreatic endocrine neoplasms.

Meanwhile, epidemiological studies indicated that higher circulating IGFBP3 level were an increased risk of breast cancer.

Eligibility Criteria:
Inclusion Criteria:

1. Patients at South Egypt Cancer institute and diagnosed Colorectal cancer patients
2. Patients not went to surgery

Exclusion Criteria:

1. patients receive any anti-cancer therapy.
2. Patients diagnosed with other concomitante cancer or chronic diseases
Gemcitabine and Oxaliplatin (Gem-Ox) Plus Glivec in Gemcitabine-refractory Pancreatic Cancer

The main research objective is to work out the optimal doses of the novel combination of gemcitabine, oxaliplatin and imatinib mesylate (glivec) in patients with advanced pancreatic cancer that has progressed during or after treatment with first-line gemcitabine.

Using the phase I study design, the dose of gemcitabine will be escalated in several steps to identify the highest tolerable dose that can be given safely. Based on pre-defined dose-limiting toxicity, the maximum tolerated dose of the combination will be identified and a safer dose for further evaluation of this regimen in pancreatic cancer selected. The primary objectives are therefore based around safety of the drug combination.

Eligibility Criteria:
Inclusion Criteria:

* age \> 18 years
* gemcitabine-refractory, histologically confirmed pancreatic cancer (progression during or within 6 months of first-line treatment)
* locally advanced or metastatic disease with measurable or non-measurable disease
* life expectancy of greater than 10 weeks
* prior treatment with investigational therapies including EGFR and VEGF antagonists is allowed when administered\>4 weeks prior to start of therapy

Exclusion Criteria:

* any serious uncontrolled medical condition
* prior radiation treatment is not allowed
* no prior chemotherapy within the previous 4 weeks
* known peripheral neuropathy \> CTCAE v 3.0 grade 1; absence of the deep tendon reflexes as the sole neurological abnormality does not render the patient ineligible
* known brain metastases
* lack of physical integrity of the upper GI tract, malabsorption syndrome, or inability to take oral medication
* fertile women (\<2 years after last menstruation) and men of childbearing potential not willing to use effective contraception
* pregnancy or breast feeding
The Clinical Study of Modern Therapies on Flora in Body Fluids and Blood of Malignant Tumor Patients

The clinical study of modern therapies on flora changing in blood, oral cavity, urethra and intestinal tract of patients with malignant tumors. The study is observational. Patients are diagnosed cancer based on pathology or cell biology. The sample of flora will be obtained from their blood, oral cavity, urethra and intestinal tract, mainly to study what modern therapies lead to the influence of microecological environment including diversity and abundance of bacteria in patients who received malignant tumors. Immunological examination and Blood biochemistry evaluation include the number ratio, activity and function of immune cell, the immune cell marker(CD3, CD4, CD8, etc), C-reactive protein(CRP), tumor necrosis factor(TNF), Inflammatory stimulant factor(IL-2, IL-6, etc), tumor marker(CEA, AFP, etc),etc. Clinical evaluation includes image data(CT/MRI), quality of life(QOL), no disease progression survival, total survival, objective disease remission rate, etc.

This study collected samples of feces, urine, discarded blood and pharyngeal swab specimens from clinical laboratory from patients with malignant tumors in thoracic surgery department, general surgery department, oncology department and etc before and after treatments which contain chemotherapy, radiation therapy, immune targeted, endocrine therapy, surgery, traditional Chinese medicine and other modern therapies. Researchers will analyze the samples by oral flora, urethra, blood flora bacteria, the species diversity and abundance of the intestinal flora. Besides, quantitative analysis of inflammatory stimulators, c-reactive protein and tumor necrosis factor in peripheral blood was conducted to observe the relationship between the change characteristics of blood, oral, intestinal, urinary tract flora and urine composition caused by treatment and the therapeutic effect and prognosis.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-85 years old, male or female
2. Clinical diagnosis of malignant tumors
3. It is planned to receive cancer treatment
4. The genre of therapies is not limited, which contain chemotherapy, radiation therapy, immune targeted, endocrine therapy, surgery, traditional Chinese medicine and other modern therapies

Exclusion Criteria:

1. Cancer treatment before therapies
2. Previous history: He has suffered from intestinal microecology-related diseases such as cirrhosis, ulcerative colitis, Crohn's disease, irritable bowel syndrome, and urinary system diseases
3. Neurological, psychiatric or unconscious disorders.
4. The following drugs were used within 2 weeks before enrollment:

   1. Probiotic preparations, various prebiotic preparations, etc
   2. gastrointestinal peristaltic drug;
   3. Take drugs known to have a significant effect on the intestinal and urethral flora within half a year (such as proton pump inhibitors, purgatives, bismuth, adsorbents, non-steroidal anti-inflammatory drugs, etc.)
5. Other situations that the researcher considers unsuitable to participate in the experiment;
Expression of EPK in Recurrent Miscarriage

The present study is based on hypotheses that some as yet unknown genetic factors may result in recurrent miscarriage (RM). Consequently, the main aim of this study was to gain new information about the underlying genetic causes of RM in the Egyptian population and to investigate the expression of ERK and p-ERK protein in human placenta and their corresponding tissue, to assess the significance of MAPK signal pathway in progression of recurrent miscarriage and PI3K-Akt Pathway.


Eligibility Criteria:
Inclusion Criteria:

1. Gestational age less than 12 weeks.
2. no uterine abnormalities (examined by ultrasonography or hysterosonogram)
3. previous history of RM, defined as two or more consecutive miscarriages

Exclusion Criteria:

1. Gestational age 12 weeks or more.
2. Endocrine etiology like (thyroid dysfunction, and uncontrolled diabetes mellitus).
3. Antiphospholipid syndrome, inherited thrombophilias, alloimmune causes.
4. Uterine anatomic anomalies
Artificial Intelligence-assisted System in Colonoscopy

In recent years, computer-aided diagnosis system based on artificial intelligence (AI) has been used in colorectal polyp detection. In recent years, computer-aided diagnosis system based on artificial intelligence (AI) has been used in colorectal polyp detection. However, whether AI-assisted can improve the adenoma-detection rate (ADR) is inconclusive. This study aims to evaluate the real-world performance of an AI system that combines polyp detection with colonoscopy quality control.

This study aims to explore the clinical application value of AI-based polyp detection and quality control function by comparing the data of polyp detection rate and adenoma detection rate in multiple centers with and without AI-assisted colonoscopy in a multicenter, prospective real world study. However, whether AI-assisted can improve the adenoma-detection rate (ADR) is inconclusive. This study aims to evaluate the real-world performance of an AI system that combines polyp detection with colonoscopy quality control.

This study aims to explore the clinical application value of AI-based polyp detection and quality control function by comparing the data of polyp detection rate and adenoma detection rate in multiple centers with and without AI-assisted colonoscopy in a multicenter, prospective real world study.


Eligibility Criteria:
Inclusion Criteria:

1. age \> 50 years old;
2. required diagnostic colonoscopy, screening colonoscopy, or follow-up colonoscopy;
3. voluntarily sign informed consent;
4. Commitment to abide by the study procedures and cooperate with the implementation of the whole process of the study.

Exclusion Criteria:

1. have participated in other clinical trials, signed informed consent and are in the follow-up period of other clinical trials;
2. known polyposis syndrome patients;
3. patients with known IBD;
4. patients considered by the investigators to be unsuitable or unable to undergo complete digestive endoscopy and related examinations;
5. high-risk diseases or other special conditions considered by the investigator to be unsuitable for clinical trial participation.
SonoElastography of Median Nerve in Rheumatoid Arthritis

To assess the role of ultrasonography and SE in detecting the median nerve changes before progression to CTS in patients with RA.

Rheumatoid arthritis (RA) presents with persistent pain, stiffness, progressive joint destruction, functional disability, and progressive morbidity and mortality, and is a chronic systemic autoimmune disease.1 The cause of RA remains unknown, but the pathological mechanism of synovial inflammation may result due to the complex interplay of genetic immunology and environmental factors.2 Early diagnosis is fundamental to prevent the permanent sequel of RA. Recent advances in diagnostic imaging in rheumatology have benefited patients clinically and also provided information related to the pathophysiology of diseases like arthritis.

Ultrasound (US) and magnetic resonance imaging were most commonly used in diagnosing and monitoring RA progression in joints and related joint structures.3 US elastography measures tissue elasticity using high-frequency sound waves to assess tissue's static or dynamic deformation behavior after a stimulus is applied. This technique has been described most commonly in the context of isotropic tissues, such as the liver and neoplastic diseases, but is now becoming of more interest in anisotropic tissues, such as those in the musculoskeletal system.4

Eligibility Criteria:
Inclusion Criteria:

* All patients diagnosed with RA and ruling out CTS by clinical evaluation that included Phalen's test, a manual muscle test of the abductor's muscle, and a search for Tinel-like signs and thenar muscle atrophy. Controls - Age- and sex- matched cases without RA undergoing US for causes unrelated to RA or CTS. The criteria for RA were adopted from The American Rheumatism Association (1987) for the classification of RA.

Exclusion Criteria:

* History of a condition other than RA that could cause CTS (e.g., diabetes mellitus, acute trauma, pregnancy ,hypothyroidism, hyperthyroidism, connective tissue disease)History of surgery for a wrist or hand fracture.
* History of other systemic neurological disorders or radiculopathy Bifid median nerve or any mass lesion identified on US examination Pregnant patients were excluded.
Effect of Pre-emptive Intravenous Immunoglobulin (IVIG) on the Incidence of Septic Episodes in Pediatric Burn Patients

Effect of pre-emptive intravenous immunoglobulin administration on the incidence of septic episodes in pediatric burn patients: A randomized controlled study.

After randomization, Treatment and control groups will receive Parkland formula (4 ml/kg per percent total burn surface area; (TBSA), counting moderate (partial thickness) and severe (full thickness) burn area only) using Ringer's lactate solution (half of the fluid will be given over the first eight hours and the remaining half will be given over the next 16 hours), plus normal 24-hour maintenance fluid requirements using glucose solution.

When initiating Parkland, treatment group (Group A) will receive intravenous immunoglobulin IVIG (LIV-GAMMA "S/D treated Human Immunoglobulin" 2.5 grams/50 ml) with a dose of 200 mg/kg once on admission.

* On each septic or septic shock episode in either groups, the patients will be treated with appropriate antibiotics empirically or culture-based.

  * Assessments
  * On admission, all patients included in the study will be fully examined clinically to identify the extent and area of burn and clinical signs of infection or dehydration as fever, respiratory rate, urinary output and capillary refill. Besides, non-invasive blood pressure (systolic blood pressure (SBP), diastolic blood pressure (DBP) and mean arterial blood pressure (MAP)), electrocardiogram and arterial oxygen saturation will be assessed.
  * Parameters to be measured
* Serum immunoglobulin G( IgG) level,
* Serum micro RNA (miR-25) ,
* Serum C reactive protein (CRP) level,
* Serum lactate,
* Serum Procalcitonin
* Serum Malondialdehyde(MDA).
* Serum Glutathione Peroxidase .

  * In addition, Complete Blood picture with differential, coagulation profile, liver function tests (alanine transaminase (ALT), aspartate amino transferase(AST), Albumin and Bilirubin), and kidney functions (Blood urea nitrogen (BUN) and serum creatinine) will be evaluated.

Pan cultures (blood with/without wound culture, throat swab or sputum culture and urinary analysis and culture), will be withdrawn for baseline readings and redrawn if any signs of systemic inflammatory response,

Eligibility Criteria:
Inclusion Criteria:

All burn patients 1 to 5 years old with 10% or greater burn area of TBSA .

Exclusion Criteria:

* Patients with septic shock (evidence of infection and inotropes) .
* Burns more than 48 hours duration.