cyrilzakka/clinical-trials huggingface dataset:
Assessment Of Lipid Profile In Cirrhotic Patients

Cirrhosis is defined anatomically as a diffuse process with fibrosis and nodule formation. It is the result of the fibrogenesis that occurs with chronic liver injury.

Lipoproteins are complexes of lipid and proteins that are essential for transport of soluble vitamins Liver cells play a serious task in the regulation of lipid metabolism. The principal location for lipoprotein and cholesterol synthesis is in the liver.

In healthy individuals, a compound equilibrium is preserved between utilization, biosynthesis, and transfer of lipid fractions.

Many diseases that affect the parenchyma can lead to changes in the structure of lipoproteins and transport throughout the blood.

Nevertheless, in cirrhotic patients, the metabolism of lipid is changed such that glycogen stores are significantly diminished, contributing to malnutrition and biolysis.

Cirrhosis is defined anatomically as a diffuse process with fibrosis and nodule formation. It is the result of the fibrogenesis that occurs with chronic liver injury.

Lipoproteins are complexes of lipid and proteins that are essential for transport of soluble vitamins Liver cells play a serious task in the regulation of lipid metabolism. The principal location for lipoprotein and cholesterol synthesis is in the liver.

In healthy individuals, a compound equilibrium is preserved between utilization, biosynthesis, and transfer of lipid fractions.

Many diseases that affect the parenchyma can lead to changes in the structure of lipoproteins and transport throughout the blood.

Nevertheless, in cirrhotic patients, the metabolism of lipid is changed such that glycogen stores are significantly diminished, contributing to malnutrition and biolysis.

The preceding studies have reported that cirrhotic patients have abnormal metabolism of lipids, especially reduction in cholesterol level and hypobetalipoproteinemia.

These alterations develop together with the progression of liver disease and may be considered as a prognostic markers for liver decompensation.

The maneuvers concerned with the decline of lipid particles in patients with cirrhosis are compound and need multiple researches for complete understanding.

Protein microsomal triglyceride (TG) transfer protein -+ MTP\], enzymatic (acylCoA: cholesterol acyltransferase), and apoprotein (Apo AI) reduction are considered to be linked to these changes.

Owing to the wide occurrence of liver disease in Egypt, we made this study to assess lipid profile in cirrhotic patients and to evaluate its relation to the degree of cirrhosis.

Eligibility Criteria:
Inclusion Criteria:

* Cirrhotic patients .

Exclusion Criteria:

* 1-Patients with diabetes mellitus,malignancy,uremia. 2-Patients with history of drugs for dyslipidemia. 3- Patients presented with hepatocellular carcinoma 4- Wilsons disease. 5-Rheumatoid arthritis. 6- Systemic lupus.
Testing Feasibility of Care Coordination and Motivational Interviewing for Women With a Recent Preterm Birth

This study continues an adaptation of care coordination to address the needs of women after preterm birth. This is a small single arm open trial designed to test intervention implementation and refine the intervention before ongoing feasibility testing.

Interventionists will be trained in care coordination strategies and Motivational Interviewing (MI) techniques. Following training, investigators will enroll eligible women from a postpartum unit at a single hospital, or within two weeks of birth. Investigators will assess feasibility, adoption, reach, and fidelity of the intervention and of study data collections strategies. The intervention protocol will be revised to reflect these assessments.

Eligibility Criteria:
Inclusion Criteria:

1. Female
2. Less than 45 years old
3. History of preterm birth (\< 34 weeks gestational age or 34 - 36 weeks with identifiable risk factors for recurrent preterm birth which may include low preventive care utilization, tobacco use, obesity, depression or anxiety, or history of unmet contraceptive needs)
4. Intention to seek pediatric care at one of two pediatric primary care sites
5. Medicaid insurance

Exclusion Criteria:

1. History of sterilization procedure.
2. Plan to move away from the area or transfer pediatric primary care within six months of enrollment.
3. Limited English proficiency
Effect of Thiamin Supplementation on Thiamin Status in Children With Heart Disease Receiving Diuretic Drugs

The purpose of this study is to determine effect of thiamin supplementation on thiamin status by measuring thiamin pyrophosphate effect in children with heart disease receiving diuretic drugs.

Children with heart disease receiving diuretic drugs are susceptible to thiamin deficiency due to increase renal loss. Thiamin deficiency causes abnormal cardiac contraction resulting in heart failure.

Eligibility Criteria:
Inclusion Criteria:

* Children aged 1 month old to 15 years old diagnosed as heart disease
* Receiving diuretic drugs at least 1 month

Exclusion Criteria:

* Receiving thiamin-containing vitamins
* Receiving hemodialysis or peritoneal dialysis
* Having problems of intestinal malabsorption, chronic lung disease, red blood cell abnormality such as thalassemia , abnormal hemoglobin typing, G6PD deficiency
* Receiving thiamin-producing probiotics
* Receiving inotropic drugs
* Severe anemia: Hb \< 7 g/dL
Effect of Bifidobacterium Adolescentis on Aging in Healthy Adults (45-65 Years)

This study will include middle-aged and elderly people aged 45-65 years to carry out the translational study of Bifidobacterium adolescentis, and design a double-blind, randomized controlled clinical trial according to strict inclusion/exclusion criteria, using aging-related functional indicators, intestinal flora, DNA methylation and other advanced aging characteristic examination methods to fully and accurately assess the effects and safety of Bifidobacterium adolescentis on aging, which has the advantages of strong safety, high practice and high credibility compared with previous clinical trial protocols, laying an important foundation for improving probiotic anti-aging and exploring the development of aging intervention programs suitable for the Chinese population.


Eligibility Criteria:
Inclusion Criteria:

1. 45-65 years of age.
2. Attending or consulting at the specialized outpatient clinics for aging diseases at 2nd Affiliated Hospital, School of Medicine, Zhejiang University and Sir Run Run Hospital, School of Medicine, Zhejiang University
3. Voluntarily participate in this study and sign the informed consent form.

Exclusion Criteria:

1. Known history of tumor.
2. women who are breastfeeding.
3. Those who wish to continue having children.
4. those who are unable to cooperate with investigations and testing
5. abuse of drugs, alcohol or other substances.
6. history of cardiac disease: atherosclerotic disease, heart failure, unstable angina, stable angina, etc. and chronic hypoxic diseases: emphysema, pulmonary heart disease, etc.
7. history of chronic gastrointestinal diseases (pancreatitis, IBS) and intestinal surgery.
8. endocrine disease with hyperthyroidism or cortisolism.
9. abnormal liver function, with ALT（Alanine transaminase）/AST（Aspartate aminotransferase） exceeding 2 times the upper limit of normal.
10. abnormal renal function with blood creatinine ≥ 133 μmol/L.
11. Type I diabetes or insulin-dependent type II diabetes.
12. poorly controlled chronic disease (hypertension, hyperlipidemia, type II diabetes, etc.) that is clinically unstable.
13. Vulnerable groups, including critically ill, mentally ill, cognitively impaired, minors, pregnant women, illiterate, etc.
Effect of Radiation and Its Timing on Breast Reconstruction in Chinese Patients

The purpose of the study is to investigate the impacts of radiation and the timing of radiation on autologous and prosthetic-based breast reconstruction in Chinese post-mastectomy breast cancer patients. The study aims to optimize the timing for autologous/prosthetic breast reconstruction which delivers the best aesthetic results while maintains low complication rate and best integrates into the comprehensive breast cancer treatment. The study is open to all female breast cancer patients undergoing breast reconstruction in the department of breast reconstruction in Tianjin medical university cancer institute and hospital.

In breast cancer patients, post-operative radiation therapy is an important component in breast cancer management. However, in the context of breast reconstruction, radiation can have adverse effect as it increases the rate of fat necrosis and leads to fibrosis/ capsular contracture in the reconstructed breast mounds. It is therefore necessary to investigate the best timing for breast reconstruction, especially in those patients which post-operative radiation is required, which does not interfere with overall breast cancer treatment while produces the best surgical, aesthetic and psychological outcome. Most studies in this field are retrospective, and studies on Chinese cohort are also rare. This multi-center prospectively designed clinical trial will include several medical centers across China. The investigators will allocate the patients into three arms based on the status and sequence of radiation and breast reconstruction, and will further stratify the groups based on the different approaches of reconstruction (autologous/ prosthetic based). Both objective and subjective (patient oriented) methods will be employed to make evaluations involving surgical, aesthetic, and psychological outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with breast cancer
* Karnofsky Performance Status (KPS) larger than 70
* Underwent autologous or prosthetic based breast reconstruction
* No severe deficiency in hematological, cardiovascular system, no immune-deficiency, no severe abnormal liver or kidney function.

Exclusion Criteria:

* Metastatic breast cancer
* Local recurrence after mastectomy
* Prior radiation history to chest wall due to other tumors
* Radiation performed more than 6 months after mastectomy
* Interruption of radiation more than 2 weeks
* Gravida or during lactation
* Concurrently undergoing psychotic disorders
FT596 as a Monotherapy and in Combination With Anti-CD20 Monoclonal Antibodies

This is a Phase I dose-finding study of FT596 as monotherapy and in combination with Rituximab or Obinutuzumab in subjects with relapsed/refractory B-cell Lymphoma or Chronic Lymphocytic Leukemia. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.


Eligibility Criteria:
Key Inclusion Criteria:

Diagnosis of B-cell lymphoma or CLL as described below:

B-Cell Lymphoma:

* Histologically documented lymphomas expected to express CD19 and CD20
* Relapsed/refractory disease following prior systemic immunochemotherapy regimen

Chronic Lymphocytic Leukemia (CLL):

* Diagnosis of CLL per iwCLL guidelines
* Relapsed/refractory disease following at least two prior systemic treatment regimens

ALL SUBJECTS:

* Capable of giving signed informed consent
* Age ≥ 18 years old
* Stated willingness to comply with study procedures and duration
* Contraceptive use for women and men as defined in the protocol

Key Exclusion Criteria:

ALL SUBJECTS:

* Females who are pregnant or breastfeeding
* Eastern Cooperative Oncology Group (ECOG) Performance Status ≥2
* Body weight \<50 kg
* Evidence of insufficient organ function
* Receipt therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter; or any investigational therapy within 28 days prior to Day 1
* Currently receiving or likely to require systemic immunosuppressive therapy
* Prior allogeneic hematopoietic stem cell transplant (HSCT) or allogeneic CAR-T within 6 months of Day 1, or ongoing requirement for systemic GvHD therapy
* Receipt of an allograft organ transplant
* Known active central nervous system (CNS) involvement by malignancy
* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis, or neurodegenerative disease
* Clinically significant cardiovascular disease
* Known HIV infection
* Known active Hepatitis B (HBV) or Hepatitis C (HCV) infection
* Live vaccine \<6 weeks prior to start of lympho-conditioning
* Known allergy to albumin (human) or DMSO
Long Term Outcome of Argon Plasma Coagulation of Cervical Heterotopic Gastric Mucosa as an Alternative Treatment for Globus Sensations

APC of gastric inlet patches is successful for the treatment of globus sensations in the throat (Bajbouj et al Gastroenterology 2009; 137:440-4). There is no data for long term efficiency of this treatment. To measure long term efficacy all patients treated with this therapy in our clinic were followed up with complaint-evaluation sheets and endoscopy.


Eligibility Criteria:
Inclusion Criteria:

* former APC therapy of gastric inlet patches as treatment for globus sensations
* at least 6 month since last APC therapy

Exclusion Criteria:

* patients with reduced general condition
* malignancy of the upper gastrointestinal tract
* patients older than 80 years
Cold Oxygen Lung Preservation and Ventilation With the "Angel Cooler"

The objective of this feasibility study is to evaluate continuous temperature monitoring, oxygen (O2) concentration and ventilation with positive end expiratory pressure (PEEP) to keep lungs cooled at 4-8 degrees Celsius, with continuous O2 concentration of 100% and inflated with a PEEP of 8-10 during the entire cold ischemic period.

The Angel Lung Cooler is a lung preservation method for transplantation. The device has temperature and airway pressure sensors that assess the oxygen temperature in the airways to confirm during the entire preservation time that desired airway temperatures (between 8 and 10 oC) and mean airway pressure to keep the lungs inflated during transportation is optimized.

For the purposes of the trial, the Angel Cooler will be in the operating room at time of transplant when both of the lungs are explanted. The explanted lungs (those removed and not the donor lungs) will be connected to the cooler to determine inflation and temperature changes of the lungs. This procedure will take approximately 5 - 20 minutes. The lungs will then be disconnected from the cooler and then returned to the back table for transport to the Pathology department. As part of standard procedures, the lungs remain in the Operating room for a few hours before they are transported to the Pathology department.

Eligibility Criteria:
Inclusion Criteria:

* Age at least 18 years
* Subjects who have signed Universal Consent are eligible for participation.
* Subjects willing to sign the Universal Consent for the use of their lungs in this study.

Exclusion Criteria:

• Explanted lungs of those who have not signed the Universal Consent (UC) or who have declined participation in the UC will be excluded.
Developing a Complex ex Vivo Endometrial Tissue Model to Improve Endometriosis Care

Endometriosis is a chronic gynaecological disease characterised by the growth of endometrium outside the uterus. It affects 10% of childbearing age women.

There is no cure for endometriosis. Hormonal treatments should be the first line therapy. The benefit-risk ratio of symptomatic treatment with hormone therapy varies greatly from one woman to another. The pathophysiology of endometriosis and the mechanisms of action of these treatments are still poorly understood. This may be due to the lack of an optimal experimental model for studying the disease.

The aim of this project is to develop a complex ex vivo endometrial model recapitulating the organisation and properties of the human endometrium using innovative tissue bioengineering methods. This model will make it possible to develop a pre-clinical approach that predicts individual response to different types of hormonal treatment in order to optimise therapeutic choices and provide a better understanding of the effects of these treatments.


Eligibility Criteria:
Inclusion Criteria:

* Female
* People aged between 18 and 50
* Person who has or has had hormonal contraceptive treatment
* A person who has given written consent
* Person diagnosed with a benign gynaecological pathology not affecting the endometrium and requiring hysterectomy, hysteroscopy or laparoscopy or with a diagnosis of endometriosis and requiring laparoscopy or hysterectomy
* Person affiliated to the french social security

Exclusion Criteria:

* Pregnant at the time of sampling or within 3 months prior to sampling
* Breast-feeding women
* Women undergoing physiological menopause
* Anyone who has received hormonal treatment with hormones other than steroids in the three months prior to sampling
* Anyone with a non-hormonal contraceptive intrauterine device (copper coil)
* Anyone with a personal history of cancer of the breast, ovary, endometrium or cervix
* People with Lynch syndrome
* Persons under legal protection (guardianship, curatorship)
* Persons deprived of their liberty by judicial or administrative decision
* Persons with a body mass index (BMI) of less than 18.5 or more than 30
Duloxetine vs Pregabalin for Thoracotomy Pain

This study investigates the effects of preoperative use of oral combination of duloxetine and Pregabalin in comparison with preoperative oral Pregabalin only in treatment of acute postoperative and prevention of chronic pain following thoracotomy surgeries.

75 Patients, undergoing thoracotomy surgery will be randomly allocated into three equal groups, each (n=25 ), using computerized generated random tables: Group P: will receive oral Pregabalin 75mg two hour preoperatively, 12 hours postoperative and will continue for one week twice per day.

Group D:will receive oral duloxetine 30mg two hour preoperatively ...will be continued for one week once per day after breakfast .

Group C: will receive single dose of Pregabalin 75mg + duloxetine 30mg two hour preoperatively, 75mg pregabalin 12 hour postoperative and then will continue pregabalin twice per day +duloxetine once after breakfast for one week.

The total amount of morphine consumption in the first 24 hours postoperatively, total amount of intraoperative fentanyl will be recorded, change in hemodynamics ((heart rate and mean arterial blood pressure), respiratory rate and oxygen saturation will be monitored and recorded at 0,2, 4, 8, 12 ,16 \&24 hours and Visual analogue scale at 0, 2,4, 8, 12, 16 \&24 hours postoperatively then at 3rd, 5th days, 4th week and12th week will be measured.

Eligibility Criteria:
Inclusion Criteria:

* ● Physical status ASA II, III.

  * Age ≥ 18 and ≤ 65 Years.
  * Body mass index (BMI): \> 20 kg/m2 and \< 40 kg/m2.
  * Cancer patients undergoing posterolateral thoracotomy incision for cancer lung, mesothelioma or metastatectomy from the lung.
  * Patient is able to provide a written informed consent.

Exclusion Criteria:

* ● Patients with Known sensitivity or contraindication to drug used in the study

  * History of psychological disorders and/or chronic pain.
  * Previous administration of antidepressants, anticonvulsants, or opioids before surgery.
  * Patient refusal.
  * Severe respiratory or cardiac disorders.
  * Advanced liver or kidney disease.
Simultaneous OCT and B-FAF in Eyes With Alteration of the Foveal Contour

Some alterations of the foveal contour do not meet the criteria established for the definition of lamellar macular hole on the basis of optical coherence tomography (OCT). However, these alterations may show an appearance, on blue fundus autofluorescence (B-FAF) imaging, reminiscent of lamellar macular hole.

The aim of the study is to evaluate in detail these alterations recording simultaneously OCT and B-FAF.

All images will be collected using the Heidelberg Spectralis system (Heidelberg Engineering, Heidelberg, Germany) according to the prespecified imaging protocols. Blue-fundus autofluorescence (excitation wavelength at 488 nm and barrier filter at 500 nm) images and SD-OCT images will be obtained after pupil dilation.

The OCT recording protocol will consist of a sequence of 37 horizontal sections, spaced 120-µm apart, covering an area of 20° or 30° horizontally by 15° vertically, and a sequence of 24 radial sections recorded in the high-resolution (HR) mode simultaneously with infrared (IR) images.

In addition, simultaneous B-FAF/OCT images will be acquired (horizontal, and vertical OCT sections, centered on the fovea and recorded in the HR mode).

The same OCT/FAF protocol will be used for the study eye and for the fellow eye.

For the study eyes that had been examined in the past, the ''Follow-up'' function will be used in addition to the prespecified protocol to evaluate if any changes had occurred since the last scan.

Multiple other morphological characteristics will be analyzed using OCT imaging, including the status of the posterior cortex, the presence of operculum, the integrity/disruption of the external limiting membrane (ELM), ellipsoid zone (EZ), and the central and minimal foveal thickness (CFT and mFT respectively). The latter will be defined as the thinnest part of the fovea within the foveal pit identified by examining radial scans whereas the former will be measured in relation to the highest point of the foveal bulge.

All measurements will be performed using the Spectralis built-in manual caliper function at high magnification after adjusting the scale to 1:1 µm except for CFT, which will be calculated using the automated ''thickness map'' function of the Heidelberg Eye Explorer.

Eligibility Criteria:
Inclusion Criteria:

* alteration of the foveal contour not classifiable as lamellar or pseudo macular hole
* focal, well-defined increased autofluorescence signal at the fovea

Exclusion Criteria:

* intraretinal cysts not associated with break of the inner retina
* juxtafoveal telangiectasia
* ring of increased B-FAF
* vitelliform and pseudovitelliform lesions
* history of diabetes, retinal vein occlusion, uveitis, CSR, AMD or any other retinal -disease potentially associated with intra or subretinal fluid
* macular drusen
* history of submacular hemorrhage
Synergistic Effect of Vedolizumab and Pentoxifylline

The purpose of this study is to determine the synergistic effect and clinical benefits of vedolizumab and pentoxifylline in the management of patients with inflammatory bowel disease.


Eligibility Criteria:
Inclusion Criteria:

* Patients with active Crohn's disease (CD) defined by blood lab values, stool markers, abnormal MR enterography imaging, or colonoscopic findings
* Patients who are good candidates to start standard dosing of vedolizumab
* Patients who have not used an off-label or investigational drug for CD in the 8 weeks prior to screening
* Patients who have met the washout period of 8 weeks for infliximab, 4 weeks for certolizumab pegol, and 2 weeks for adalimumab if there is a history of anti-TNF exposure and 8 weeks if there is a history of exposure to natalizumab
* Oral aminosalicylates are allowed during the study, provided that the dose has been stable for at least 2 weeks prior to screening
* Oral corticosteroids are allowed provided that the dose is prednisone ≤40 mg/day or equivalent and/or budesonide ≤9mg/day and has been stable for at least 2 weeks prior to screening
* Patients are able to discontinue thiopurines (azathioprine and 6-mercaptopurine) or methotrexate upon initiation of vedolizumab
* Rectal therapies, narcotics, anti-diarrheals, probiotics, and antibiotics will be permitted at investigator discretion

Exclusion Criteria:

* Contraindications or history of allergy to PTX
* Known interaction of PTX with patient's current medications
* Use of an off-label or investigational drug for CD in the 8 weeks prior to first VDZ infusion
* Pregnancy
* GFR \<30 at any time in the 6 months prior to first infusion of VDZ
* Documented cirrhosis
* Age \<18 or \>80 years old
* Contraindication to colonoscopy at 24 week study time-point