cyrilzakka/clinical-trials huggingface dataset:
Effect of Soluble Dietary Fiber on Bacterial Translocation in Crohn's Disease

The purpose of this study is to evaluate the effect of soluble dietary fiber on bacterial translocation and mucosal immunology in patients with Crohn's disease.

Bacterial translocation (BT) is a proposed mechanism of CD. Microorganisms can be cultured from 18-48% of draining mesenteric lymph nodes from CD patients. A breakdown in barrier function in "late stage" CD has been observed in patients requiring surgery. In addition, it was found that BT influences the response to biological therapy and clinical relapse in CD. Therefore, reducing BT may be of therapeutic importance in treatment for CD.

The role of soluble dietary fiber in Crohn's disease (CD) is still inconclusive. Population based studies have shown that long-term intake of dietary fiber is associated with lower risk of CD. However, meta-analysis did not show benefit in inducing or maintaining remission. In addition, the possible mechanism of dietary fiber on CD is still unclear.

The rationale relates to the beneficial effects of fiber may be due to the production of the fiber metabolites short-chain fatty acids (SCFAs), particularly butyrate. Dietary substrates may modify the commensal microbiota or their metabolites or enhance epithelial barrier function. Recently, it was found that dietary fiber metabolites SCFA is regulatory of mucosal regulatory T cells. The current study is to examine the impact of dietary fiber on bacterial translocation,intestinal luminal microbiology, and mucosal immunology in CD patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged \>=17 years with diagnosis of CD for at least 3 months defined by histology or radiology
* ileocolonic non-penetrating disease
* Moderate active CD with CDAI 250-450
* CRP level over normal range
* Stable CD therapy with a total steroid dose not exceeding 10mg prednisolone or equivalent for 4 weeks

Exclusion Criteria:

* Infection with enteric pathogen
* Usage of probiotics, antibiotics, or prebiotics within the last month
* Change in dose of oral steroids or 5-ASA within the last 4 weeks or AZA or MTX in the last 3 months
* Dose of steroids exceeds 10 mg prednisolone per day or equivalent
* Infusion of IFX or any alternative biological therapy within the last 3 months
* Use of rectal 5-ASA or steroids within the last 2 weeks.
* Imminent need for surgery or presence of severe disease (CDAI \>450)
* Pregnancy or lactation
* Short bowel syndrome or subtotal/total colectomy
* Pure anal disease and previous proctocolectomy
* Significant hepatic, renal, endocrine, respiratory, neurological or cardiovascular disease as determined by the principal investigator
* History of cancer with a disease-free state of less than two years
* Patients with penetrating disease or small bowel lesion only.
Effects of Sustained-release Oral Sodium Nitrite on Postoperative Pain and Recovery Following Total Knee Arthroplasty

This study will determine whether a drug called sodium nitrite helps improve pain and post-operative recovery associated with knee replacement surgery.

The goal of this study is to examine the potential for oral sodium nitrite supplementation to reduce postoperative pain and inflammation and improve functional recovery in individuals undergoing unilateral revision total knee replacement. A sustained release formulation of sodium nitrite (40 mg) administered twice daily will be compared with placebo for a 30-day treatment period. Primary objectives are to evaluate pain and markers of functional improvement.

Eligibility Criteria:
Inclusion Criteria:

* Male and female individuals aged 18-70
* Ambulatory with knee pain for greater than 6 months prior to surgery, and willing and able to comply with all study requirements will be considered eligible.

Exclusion Criteria:

* Severe hypertension (systolic blood pressure greater than or equal to 200 mmHg or diastolic blood pressure greater than or equal to 120 mmHg);
* BMI greater than 45 kg/m2;
* Active smoker or stopped smoking within 6 months of enrollment;
* Active local or systemic malignancy, such as lung cancer or leukemia;
* Cardiovascular disease resulting in dyspnea at rest;
* Peripheral neurovascular disease;
* Anemia;
* Hematological disease (eg, coagulopathy, sickle cell disease/anemia);
* Hemoglobin variant;
* Glucose-6-phosphate dehydrogenase deficiency;
* Methemoglobin reductase deficiency;
* Known sensitivity to nitrites;
* Liver disease;
* Use of phosphodiesterase type 5 inhibitors;
* Use of sildenafil (Viagra);
* Systemic treatment with antibiotics, immunosuppressants including corticosteroids, medications for migraine, allopurinol, tricyclic antidepressants, antihistamines, and/or nitrates currently or in the last month;
* Use of nitrovasodilators (e.g. GTN) within the last month;
* Use of protein pump inhibitors within the last month;
* History of substance abuse;
* Recent surgery or hospitalization (within last 6 months);
* Inability to swallow a pill;
* Failure to provide full consent;
* Involvement with a worker's compensation, personal injury, or other legal matter related to participant health.
Role of Nitazoxanide and Escitalopram in Patients With Rheumatoid Arthritis

This study aims at evaluating the therapeutic effects of both Nitazoxanide and Escitalopram as adjuvant therapies in patients with Rheumatoid Arthritis and to evaluate their impact on STAT3/ JAK2, TLR /IL -1β signaling pathways.

This study is a randomized, controlled prospective study to evaluate the potential therapeutic effects of the broad -spectrum antimicrobial (Nitazoxanide) and selective serotonin reuptake inhibitor (Escitalopram) on synovial inflammation and angiogenesis when administered as add-on treatments to the current DMARDs treatments for rheumatoid arthritis patients.

A total of 90 RA patients recruited from Outpatient Clinic of Physical Medicine, Rheumatology and Rehabilitation at Mansoura University hospitals, Mansoura, Egypt will be included in the study. They will be diagnosed with RA according to the American College of Rheumatology/European League Against Rheumatism criteria 2010 (the ACR/EULAR 2010 criteria).

RA Patients who will meet the inclusion criteria will be enrolled in the study.

They will be classified into three groups:

Group 1: 30 RA patients who will receive the traditional therapy of rheumatoid arthritis for 12 weeks and serve as the control group.

Group 2: 30 RA patients who will receive traditional therapy plus Nitazoxanide 1 gm/day for 12 weeks.

Group 3: 30 RA patients who will receive traditional therapy plus Escitalopram 10 mg/day for 12 weeks.

Clinical Examinations and laboratory parameters will be performed and measured at the beginning of the study and 3 months after randomization to evaluate the efficacy of Nitazoxanide and Escitalopram in the treatment of rheumatoid arthritis.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with rheumatoid arthritis according to the ACR/EULAR 2010 criteria.
* Receiving conventional disease modified anti rheumatic drugs (DMARDS).
* Having active disease (the 28-joint disease activity score \[DAS28\] according to the CRP formula \> 2.6).
* Age between 18 and 75 years.
* Conscious and cooperative.
* Male or female.
* Sign an informed consent for the clinical study

Exclusion Criteria:

1. Pregnant or planning to be pregnant and breast-feeding women.
2. Chronic disease.
3. Other autoimmune diseases, such as systemic lupus erythematosus, Sjogren's syndrome and mixed connective tissue disease.
4. Patients treated with biological TNF-α, IL6 or IL-1β antagonists.
5. Infectious or inflammatory diseases, endocrine disorders, any past or current psychiatric or neurological diseases.
6. Clinically significant hepatic and renal dysfunction or impairment.
7. Alcohol abuse
8. Receiving therapy that interact with Nitazoxanide and Escitalopram.
9. Hypersensitivity to Nitazoxanide and Escitalopram.
Hepato-duodenal Ligament Occlusion and Classic Technique in Liver Transplant

Liver transplantation was historically associated with massive blood loss. Many factors have contributed to the decline in bleeding and transfusion in the past two decades including refinement of surgical techniques, anesthetics management and the use of point of care guided goal-directed hemostatic therapies. Increasing awareness of the adverse associations of allogenic transfusion has driven the quest for transfusion-free transplantation. Pre-operative management of preoperative anemia and targeted correction of coagulopathy is done to decrease blood transfusion. Liver transplantation is associated with the potential for massive operative blood loss, which has been recognized as one of the main causes of morbidity and mortality after liver transplantation. Therefore, a fine surgical procedure to reduce intraoperative hemorrhage is necessary for favorable outcomes of liver transplantation.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing Living Donor Liver Transplantation accepted according to hospital protocol
* All patients with liver Cirrhosis who have Porto systemic collaterals based on ct angiography

Exclusion Criteria:

* Acute fulminant liver failure
Potential Intervention Strategy With Folic Acid and Vitamin B12 in Patients With Schizophrenia

The investigators study aims are:

1. To investigate folate, vitamin B12, and homocysteine levels in patients with schizophrenia.
2. To evaluate the relationships among folate, vitamin B12, and homocysteine levels, genetic variants of one-carbon cycle pathway, psychopathology, including positive symptoms, negative symptoms, and cognition, and metabolic abnormalities in patients with schizophrenia.
3. For patients with low folate levels, the investigators would like to conduct a 24-week double-blinded, placebo-controlled of folic acid (5 mg/d) and vitamin B12 (500 ug/d) supplementation study to know whether combination of folic acid and vitamin B12 can improve patients' psychopathology or metabolic profiles, and the effects of genetic variants in one-carbon cycle pathway on treatment response.


Eligibility Criteria:
Inclusion Criteria:

1. Age 20-65 year-old.
2. Fulfill DSM-IV-TR diagnosis of schizophrenia.
3. Be treated with an antipsychotic agent for at least 6 months or at a stable dose for at least 3 months.
4. Patients with folate deficiency or insufficiency, and PANSS score at least 60 or more in the first phase screening.

Folate deficiency and insufficiency (low folate level) are defined as serum folate \< 6.8 nmol/L (3 ng/mL) and \<= 13.5 nmol/L (6 ng/mL), respectively.

Exclusion Criteria:

1. Medically unstable.
2. Currently taking vitamin supplementation.
3. Pregnancy or lactation.
4. Test positive of urine drug screen
5. Megaloblastic anemia due to folate deficiency;
6. Patients with parkinsonism (score of \> 12 on the Simpson-Angus Scale);
7. History of alcohol or other substances use disorder in past 3 months;
8. History of significant neurological illness;
9. Creatine\>1.4 ng/dl.
Ph I/II Study of Subcutaneously Administered Veltuzumab (hA20) in NHL and CLL

The purpose of this study is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in NHL or CLL patients and to confirm the safety and efficacy of veltuzumab that was previously established when administered intravenously.

The first study of veltuzumab given IV weekly in NHL patients (IM-T-hA20-01) has shown excellent tolerability and even efficacy at weekly intravenous doses as low as 80-120 mg/m2 over 4 consecutive weeks. These clinical results confirm experiments laboratory studies. Laboratory studies using Veltuzumab administered subcutaneously showed potent activity based on B-cell depletion. The current study's goal is to determine if a subcutaneous (SC) dosing schedule of veltuzumab can be established in patients with NHL or CLL

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed diagnosis of CD20 positive chronic lymphocytic leukemia (CLL)
* Either previously untreated or relapsed
* Measurable disease (at least one lesion \> 1.5 cm for NHL, or ALC \> 5,000 for CLL) see full protocol for additional criteria

Exclusion Criteria:

* Previously untreated NHL patients with Stage I and II disease (Ann Arbor classification)
* Previously untreated CLL patients with Stage 0-2 disease (Rai classification) unless specific treatment indications by NCCN guidelines exist (symptomatic, recurrent infections, end-organ function, cytopenias and steady disease progression).

see full protocol for additional criteria
Biomarker Study in Tissue Samples From Patients With Acute Myeloid Leukemia

RATIONALE: Studying samples of tissue from patients with cancer in the laboratory may help doctors identify and learn more about biomarkers related to cancer.

PURPOSE: This research study is studying biomarkers in tissue samples from patients with acute myeloid leukemia.

OBJECTIVES:

* Determine the frequency of acute myeloid leukemia (AML) that originates in CD33+ precursors or in which uncontrolled growth is restricted to CD33+ precursors.

OUTLINE: Cryopreserved acute myeloid leukemia cell samples are separated from endothelial cell by fluorescent-activated cell sorting (FACS) and analyzed for X-chromosome inactivation patterns by cytogenetic/molecular analysis and/or Humara assay.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with acute myeloid leukemia
* Known CD34+ progenitor cells
* Available freshly isolated, uncultured cell samples

PATIENT CHARACTERISTICS:

* Not specified

PRIOR CONCURRENT THERAPY:

* Not specified
Effect of a Synergistic Food Basket on Metabolic Syndrome Risk

The study evaluates the effect of a diet combining two different functional concepts on markers associated to cardiometabolic risk. The functional concepts are selected on the basis of their reported ability to influence the inflammatory tonus. It is hypothesized that the medium-term consumption of a diet combining low GI-prebiotic foods may positively influence various biomarkers associated with the risk for developing metabolic syndrome and cardiometabolic disease. Also, the combination of functional mechanisms are expected to result in synergistic effects.

The intervention is carried out in healthy women following a randomized crossover design in which an "active" (functional") diet is compared with a control diet formulated in agreement with the Nordic Dietary Recommendations but lacking the functional ingredients of the active regime.

The active diet supplies important daily amounts of dried legumes and wholegrain cereal products.

Each dietary treatment is applied for 4 weeks separated by a 4-6 week washout period. Subjects are encouraged to maintain a stable body weight under the whole trial.

Eligibility Criteria:
Inclusion Criteria:

* BMI between 25 and 32 kg/m2

Exclusion Criteria:

* Fasting blood glucose \> 6.1 mmol/L
* Medication for high blood pressure and/or elevated blood cholesterol
Safety of New Formulation of Glatiramer Acetate

The purpose of this study is to compare pain associated with injections and injection-site reactions of the approved formulation of Glatiramer Acetate (GA) versus investigational formulation of GA. In addition, the investigators will evaluate the side effects of the two formulations of GA.


Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age with a diagnosis of RRMS
* Currently injecting GA 20mg/1.0mL per day subcutaneously (SC) for a minimum of 90 days utilizing the autoject®2 for glass syringe or by a manual injection technique
* Willing to switch from autoject®2 for glass syringe to manual injection technique or continue with a manual injection technique during the course of the study
* Willing and able to be trained on a seven site injection rotation. Subject must be willing to comply with a minimum five injection site rotation plan during the study
* Willing and able to complete all procedures and evaluations related to the study
* Willing to continue to follow usual injection site preparation and routine adjunctive LISR management techniques
* Willing and able to provide written informed consent

Exclusion Criteria:

* Currently using or treated with another immunomodulating therapy (IMT) in conjunction with GA in the 30 days prior to screening for this study
* Currently using intermittent or pulse courses of corticosteroids by any route of administration in the 30 days prior to screening for this study. (Corticosteroids are prohibited for the duration of the study.)
* Currently using an investigational drug or using treatment with any other investigational agent in the 30 days prior to screening for this study
* Presence or history of skin necrosis
* Known extensive dermatological condition that could be a confounding factor
* Pregnant or planning pregnancy or breastfeeding
* Any physical condition that impairs ability to be injected at the minimum of five sites rotation
* Not able or willing to complete a daily diary
* Use of any other parenteral medications (e.g., intramuscular, SC, intravenous, etc.) either currently or in the past 30 days prior to screening for this study
* Any other medical or psychiatric conditions that would make the subject unsuitable for this research, as determined by the Investigator
* Previous participation in this study
A Study to Compare the Efficacy and Safety of Ultrasound Guided Lead Implantation for Sacral Neuromodulation (SNM) in Subjects With Overactive Bladder (OAB) With X-Ray Guided Technique

Overactive bladder(OAB,Urgency) was determined by International Continence Society as Urinary urgency, usually accompanied by frequency and nocturia, with or without urgency urinary incontinence, in the absence of urinary tract infection (UTI) or other obvious pathology.The SNM treatment involves a two-stage surgical procedure performed under local anesthesia. The device include IPG (implantable programme generator) and lead. In the initial test phase, 1st stage, electrode is placed near the sacral nerve and requires a 2 weeks assessment. This allows your doctors and you to assess your initial response according to your voiding dairy and satisfaction. In 2nd stage, SNM procedure is implantation of the IPG.

X ray guidance is harmful to both patients and doctors, while ultrasound guidance is real time visual guidance ,easy to operate by doctors and a radiation free option to challenge anatomy. Urologists are skilled in both ultrasound operations and anatomy basics and dedicating to developing better guidance technique in surgery.

The study here compare the efficacy and safety of ultrasound versus X ray guidance technique in SNM.


Eligibility Criteria:
Inclusion Criteria:

1. Age \> 16 years;
2. Subjects suitable for SNM surgery;
3. Normal upper urinary tract function;
4. Bladder volume \> 100 mL;
5. Good compliance and able to complete the follow-up assessments.

Exclusion Criteria:

1. Psychiatric or neurologic disabilities on neurologic evaluation such as multiple sclerosis, spinal cord injury, epilepsy, Parkinson's disease, stroke;
2. Bladder lithiasis or tumor (cystoscopy or ultrasonography);
3. Stress urinary incontinence;
4. Bladder outlet obstruction;
5. Diuresis \> 3 liters per 24 hours;
6. Negative at the test period or previous treatment with SNM;
7. Pregnancy and plan to be pregnancy in 2 years.
Fluorescence-guided Resection in Breast Cancer

This is an explorative phase II study to investigate the suitability of PD L 506 in the specific intra-operative detection of breast tumour tissue.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Caucasian female postmenopausal patients
* Patients with histologically confirmed primary palpable and nonpalpable breast cancer sized up to 5 cm (T1 - T2)

Exclusion Criteria:

* Suspicious lymphogenic metastases (cN1-3)
* Acute or chronic hepatic diseases
* Manifest renal diseases with renal dysfunction
* Relevant cardiac disease
* Preceding therapy of breast tumour under investigation
* Patients with multiple attempts of hook-wire placement in preparation of surgery
* Dementia or psychic condition that might interfere with the ability to understand the study and thus give a written informed consent
* Simultaneous participation in another clinical study or participation in another clinical study in the 30 days directly preceding treatment
Validation of the STAMP Screening Tool For Pediatric Nutritional Risk

Background: Insufficient nutritional intake, with or without concomitant morbidity, leads to weight loss or insufficient weight gain, is related to an increase in morbidity and mortality and exposes the child to medical complications. In addition, obesity is also related to complications during hospitalization and complications in general, and therefore early identification of these children is extremely important. Studies show that malnutrition is frequent among children upon hospitalization, where the risk of pediatric nutritional deterioration increases, even in the presence of mild stress factors. This risk is frequent mainly among children that arrive at the hospital with an initial poor nutritional status. Improving the nutritional status as part of the standard of care already at the ambulatory setting might improve the prognosis of children when ill. In Israel, nutritional screening in not conducted among children since there is no proper validated screening tool. Study objectives: To test the accuracy of the STAMP Screening Tool for pediatric nutritional risk which is designed to be used by nurses, and to compare it to a complete nutritional assessment conducted by a dietician in Clalit Health Care Services clinics. In addition, the investigators wish to examine the effects of using a screening tool for nutritional risk on the medical staff's attention to the nutritional status; this is measured by the collection of nutritional status-related data and their recording in the patient file.

Methods: 100 boys and girls aged 1 to 6, attending Clalit Health Care Services Pediatric Centers, will undergo an assessment using the STAMP Tool; a questionnaire including 3 questions with a summary score, according to which the nutritional risk level shall be determined. These children shall also undergo a complete dietician assessment in order to examine the validity of the STAMP Tool. In addition, 150 files shall be reviewed in the beginning of the research and after 6 months in order to estimate the change in medical staff's attention to nutritional status, by way of noting relevant diagnoses, reference to nutritional status- related tests and recording of anthropometric measurements.

A statistical analysis to examine the validity of the STAMP Tool shall be carried out using the kappa test (K) (30). The effect of the STAMP Tool use shall be calculated using the chi square test.


Eligibility Criteria:
Inclusion Criteria:

1. children between 1 and 6 years old
2. children treated at the clinics participating in the study

Exclusion Criteria:

1. Lack of consent or lack of Hebrew proficiency
2. children that not receiving treatment in day hospitalization at any hospital
Stress Among Final Year BAMS Students in Relation With Covid Lockdown Through CSSQ-a Cross Sectional Survey

We were randomly selected the ayurveda colleges in Kerala.Selected final year BAMS students as participants.we have also selected a group of 5 members for data colle tion.we have selected a validated Covid stress questionnaire and circulated through what's app and Gmail.we were received responses from each college with .we analyzed and interpreted data.

We were randomly selected the ayurveda colleges in Kerala.Selected final year BAMS students as participants.we have also selected a group of 5 members for data colle tion.we have selected a validated Covid stress questionnaire and circulated through what's app and Gmail.we were received responses from each college with .we analyzed and interpreted data.

Eligibility Criteria:
Inclusion Criteria 1.final year BAMS 2.irrespective of gender

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Exclusion Criteria:

* age group other than 20-22 yrs