cyrilzakka/clinical-trials huggingface dataset:
The Effect of Probiotics on Obesity. Metabolic Endotoxemia and Inflammation

In spite of the growing evidence for the beneficial effects of probiotics, their anti-obesity effects are not well examined. No previous studies were conducted in this research area in the UAE. Hence, the aims of this study are to 1) Investigate the link between metabolic derangements associated with obesity and levels of LPS and LBP; 2) Study the relatedness of low grade inflammation with the ME; 3) Investigate the food intake assessment; and 4) Investigate the effectiveness of probiotics supplement on the obesity, ME and inflammation.

This project will have two phases: 1) a cross-sectional, in which 250 adults will be recruited for the collection of anthropometric measures, food intake, and fasting blood samples to measure serum LPS, LBP, Lipid profile, IR, insulin-like growth factor, hs-CRP, IL-6, and glucose. 2) Intervention phase, in which 50 overweight subjects will be randomly assigned to either receive a daily probiotic (25 subjects) or a placebo capsule (25 subjects) during the intervention period.

General Objective:

To study the relatedness of obesity, with the associated metabolic endotoxemia and low-grade inflammation, and the effectiveness of probiotics intervention in adults, in UAE.

Specific Aims:

* Investigate the link between metabolic derangements associated with obesity and levels of LPS and LBP among the population in Sharjah, UAE.
* To examine the associated factors of obesity among the same population, including socio-demographic data, anthropometric measures, body composition analysis, and food frequency assessment.
* To investigate the correlation of the inflammatory marker Il-6 and hs-CRP to the levels of endotoxemia in lean, overweight and obese subjects.
* To evaluate the change in endotoxemia, body mass index (BMI) and inflammatory markers, after consumption of probiotics capsules of blended strains of Lactobacillus for 8 consecutive weeks among overweight and obese individuals.

Eligibility Criteria:
Inclusion Criteria:

* Accepts healthy volunteers
* 250 male and female
* age (18 - 55 yrs.)
* living in Dubai or Sharjah.

Exclusion Criteria:

* Pregnant breastfeeding or post menopause female
* individuals with thyroid
* individuals with liver, kidney or internal organs disorders
* individuals with signs of hypersensitivity
* individuals with have known allergy to probiotics, immune-disorder, malignant tumor.
* individuals with any major surgery during the last 6 months
* current smokers individuals with, acute illness within 2 weeks before collecting blood samples
Real-time Interaction and Motion Tracking in VR for Telerehabilitation

Current technology for telerehabilitation is limited to be audio- or video- based interaction without an objective and accurate measure of motor functions. A technology integrating motion tracking with 3D immersive virtual reality has been developed by an interdisciplinary team to shift the paradigm of telerehabilitation. We aim to take the significant step to develop the patient-centered telerehabilitation that will feature real-time patient-therapist interaction with functions of tele-monitoring, tele-diagnosis, and tele-therapy. Such an interactive telerehabilitation is expected to increase patient adherence to therapy and minimize the existing health disparities.

By innovatively integrating the 3D motion tracking with 3D immersive virtual reality (VR), the real-time user interaction and simultaneous motion tracking and analysis in the immersive VR environment were made possible. We now propose to customize this technology for telerehabilitation. The ultimate goal is to build a VR-based interactive tele-rehab system that is patient-centered, with augmented feedback and tele-presence of therapist to assist rehabilitative exercises and recovery of motor functions in both real and virtual environment. To achieve this goal, we are specifically tackling three problems.

* 1: Cross validating the precision of motion data captured in VR. We will modify our current software (Unity-based) so that it can work simultaneous with two motion tracking systems (Optical tracking and Magnetic tracking) to capture motion data in a 3D VR environment. The recorded data in our software will be compared and correlated with those data recorded by the two motion tracking systems in 3D for examination of accuracy.
* 2: Building and testing the network code for remote data transmission and interaction. We will write network code to enable the remote transmission of motion tracking data between two sites. The latency of data transmission will be tested to determine the minimum speed of internet for implementing such a tele-rehab system.
* 3: Designing and implementing a VR interaction task for remote monitoring and diagnosis. A 3D interactive VR task will be built for real-time local interaction and the remote monitoring, assessment and intervention.

Eligibility Criteria:
Inclusion Criteria:

* Only the key researchers of this project can participate in the study

Exclusion Criteria:

* Any individual who is not the responsible researcher in this project shall not participate in the study.
Evaluation of an Investigational Multi-Purpose Disinfecting Solution for Care of Soft Contact Lenses

The objective of the study was to clinically evaluate the safety and effectiveness of a new multi-purpose disinfecting solution for soft contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Successful daily wear of FDA Group I or IV lenses on a two-week or longer replacement schedule for at least one month.
* Use of a multi-purpose solution only as the pre-study care regimen for at least one month (rewetting drops use is also acceptable).
* Successful lens wear for at least 8 hours per day.
* Vision correctable to 20/30.
* Normal eyes - no current ocular abnormalities that prevent successful contact lens wear.
* No corneal surgery within the past 12 months.
* No systemic disease that affects that eye or that could be worsened by the use of contact lenses or solutions.
* No over-the-counter or prescription ocular medication.
* No enrollment in another clinical study within 30 days prior to enrollment.

Exclusion Criteria:

* None
Short Term Status of Free Dermal Fat Autografts for Complex Craniofacial Wounds

This study will evaluate the use of free autologous dermal fat grafting (also called free dermal fat autografting) to treat complex craniofacial wounds that have failed standard treatment and to understand how well these grafts work to repair wounds long term. Patients who have undergone free autologous dermal fat grafting to treat complex craniofacial wounds less than 1 week ago will have photographs and small biopsies taken of the area that was grafted. Patients will be followed for 2 years to monitor the area that was grafted.

A complex craniofacial wound is a wound on the head or face that will not heal, despite efforts to heal the wound with standard treatments, such as antibiotics and surgery to clean the wound. Currently, there are no good treatment options for these types of complex craniofacial wounds. This study will evaluate what happens when free dermal fat autografting is used to help treat complex craniofacial wounds by evaluating the area where the graft was placed to better understand how these types of grafts function. Free dermal fat autografting is the process of taking fat from under the outer layer of skin and moving it to another part of the body of the same individual. Although free dermal fat autografts have been used for many decades in plastic and reconstructive surgery to help a variety of patients suffering from different problems, only one study has used them to help heal complex craniofacial wounds. This use of free dermal fat autografting is not considered to be experimental or an investigational product by the US Food and Drug Administration (FDA). Still, the use of free dermal fat autografting has not been formally evaluated to understand how these types of grafts help patients with complex craniofacial wounds.

Eligibility Criteria:
Inclusion Criteria:

* Presence of a complex craniofacial wound, defined by failure of initial reconstructive and antibiotic treatment and the presence of chronic infection, exposed hardware, irradiated local tissue, or soft tissue volume loss
* Presence of wound contracture, breakdown of overlying tissue, or challenging anatomical deformities
* Patient has had two or more failed reconstructive attempts or has failed two or more attempts to treat local infection
* Speak, read, and understand English
* Willing to freely give consent
* Is able or has a legal representative to give consent

Exclusion Criteria:

* Absence of a complex craniofacial wound, defined by failure of initial reconstructive and antibiotic treatment and the presence of chronic infection, exposed hardware, irradiated local tissue, or soft tissue volume loss
* Absence of wound contracture, breakdown of overlying tissue, or challenging aesthetic deformities
* Patient has not had two or more failed reconstructive attempts or has not failed two or more attempts to treat local infection
* Does not speak, read, or understand English
* Unwilling to freely give consent
* Is unable or does not have a legal representative to give consent
Clinical Effects and Cost-effectiveness Analysis of Early Anti-viral Therapy on HBV-related Compensated Liver Cirrhosis

Though newly reported HBV infection and HBsAg prevalence in China have greatly decreased, patients who had been chronically infected with HBV, especially those with liver cirrhosis cause great burden on public health care. In view of economic development level, drug availability and lack of independent health economics evidence, the investigators are still unable to give specific guidelines for HBV related compensated liver cirrhosis in China. Therefore, the investigators aim to investigate clinical effects and cost-effectiveness of two early anti-viral therapy strategies on HBV related compensated liver cirrhosis through this prospective, open-label, multicenter and nonrandomized study.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* aged 18-70 years
* clinical diagnosis of compensated liver cirrhosis

  1. liver biopsy showing cirrhosis
  2. endoscopy: esophageal varices , exclusion of noncirrhotic portal hypertension
  3. if no biopsy or endoscopy ，should meet two of the four:

     * Imaging(US, CT or MRI, et al) showing Surface nodularity： Echogenecity （spleen pachydiameter \> 4.0cm or\> 5 costal region）

       * PLT \< 100×10 \< 9 \>/L，no other interpretation

         * ALB \< 35.0 g/L, or INR \> 1.3, or CHE \< 5.0KU/L

           * Liver stiffness measurement value \> 12.4 kpa
* HBeAg(+)with HBVDNA \> 10 \< 3 \> IU/mL or HBeAg(-) wtih HBVDNA \> 102 IU/mL

Exclusion Criteria:

* patient with decompensated liver cirrhosis:presence of ascites, variceal hemorrhage,hepatic encephalopathy
* allergic to any ingredients of the drugs
* patient complicated with alcoholic liver disease, autoimmune liver disease, heretic liver disease, drug induced liver disease,nonalcoholic liver disease or other chronic liver disease.
* AFP \> 100ng/ml or Cr \> 1.5×ULN
* pregnant woman
* patient with severe disease or other organ failure
* patient with any tumors
* patient with sever mental disease.
* patients with any disease or condition which the investigator or treating physician feels would interfere with the trial or the safety of the subject
The Efficacy and Safety of Ramosetron in Patients Undergoing Off Pump Coronary Artery Bypass Surgery

The purpose of this study is to assess the effects of ramosetron on corrected QT interval in patients undergoing off pump coronary artery bypass surgery.


Eligibility Criteria:
Inclusion Criteria:

* Elective off-pump coronary artery bypass graft surgery

Exclusion Criteria:

* Emergency operation
* preoperative use of any inotropics or mechanical assist device
* severe liver disease (\>Child class II)
* dialysis dependent renal failure
* Left ventricular ejection fraction \<30 %
* Combined major surgery like carotid endarterectomy
* Previous allergy history to any 5-hydroxytryptamine type 3 (5-HT3) antagonist
* Preoperative QT prolongation ( 500 \>msec) or arrhythmia
A Study to Determine if an Investigational Pain Medicine Provides Relief of Chronic Pain After a Shingles Outbreak

The purpose of this study is to determine whether T-62 is effective in providing relief of pain that can occur after an individual experiences a shingles outbreak, which is an infection in adults caused by the same virus that causes chicken pox.


Eligibility Criteria:
Inclusion Criteria:

* Has a clinical diagnosis of Postherpetic Neuralgia (PHN)
* Experiencing pain for at least 3 months after the healing of shingles rash
* Has at least a weekly average pain intensity of equal to or greater than 4 out of 10
* Females must not be pregnant or breastfeeding and practicing an acceptable method of birth control, or be surgically sterile or post-menopausal
* Will not consume grapefruit or grapefruit juice during the study

Exclusion Criteria:

* Has a current acute or unstable chronic disease other than Postherpetic Neuralgia (PHN)
* Has clinically important medical disorder
* Uses certain types of medications for heart conditions
* Unwilling/unable to discontinue use of medications for treatment of neuropathic pain
* Has a history of hypersensitivity to any medication or soy product
* Has liver or kidney disease
* Has asthma that required treatment within the last year
* Has HIV or hepatitis (other than hepatitis A)
* Has a history of alcohol abuse within the past 2 years
* Has a history of (within last 2 years) or currently abuses prescription or illegal drugs
Pivotal IDE Study of the BRYAN(R) Cervical Disc Prosthesis in the Treatment of DDD Versus ACDF

The purpose of this study is to establish the safety and effectiveness of the BRYAN(R) Cervical Disc Prosthesis in treating single-level degenerative disc disease of the cervical spine.

Bryan(R) Cervical Disc Prosthesis is indicated in skeletally mature patients for reconstruction of the disc from C3 to C7 following single level discectomy for intractable radiculopathy and/or myelopathy.

Eligibility Criteria:
Inclusion Criteria:

The indication studied was degenerative disc disease (DDD) at a single level between C3 and C7 for any combination of disc herniation with radiculopathy, spondylotic radiculopathy, disc herniation with myelopathy, or spondylotic myelopathy.

The following additional inclusion criteria had to be present:

* At least 6 weeks unsuccessful conservative treatment, except in cases of myelopathy requiring immediate treatment (e.g., acute onset of clinically significant signs);
* Requirement for surgical treatment demonstrated by CT, myelography and CT, and/or MRI;
* Skeletally mature (≥ 21 years of age);
* Preoperative Neck Disability Index score of ≥ 30 and at least one clinical sign associated with level to be treated;
* Willing to sign informed consent and comply with protocol.

Exclusion Criteria:

Subjects were excluded if they had any of the following:

* Any of the following at the treated level:

  * Significant cervical anatomical deformity; e.g., ankylosing spondylitis, rheumatoid arthritis, etc.
  * Moderate to advanced spondylosis. Patients who demonstrate advanced degenerative changes. Such advanced changes are characterized by any one or combination of the following: bridging osteophytes, marked reduction or absence of motion, collapse of the intervertebral disc space of greater than 50% of its normal height;
  * Radiographic signs of subluxation greater than 3.5 mm;
  * Angulation of the disc space more than 11 degrees greater than adjacent segments;
  * Significant kyphotic deformity or significant reversal of lordosis;
* Axial neck pain as the solitary symptom;
* Previous cervical spine surgery;
* Metabolic bone disease, such as osteoporosis, defined as a BMD T-score equal to or worse than 2.5. If significant radiolucence is detected, a BMD scan in the spine, wrist, and femoral neck must be obtained.
* Active systemic infection or infection at the operative site;
* Known allergy or to titanium, polyurethane, or ethylene oxide residuals;
* Concomitant conditions requiring steroid treatment;
* Diabetes mellitus requiring daily insulin management;
* Extreme obesity, as defined by NIH Clinical Guidelines Body Mass Index;
* A medical condition that may interfere with the postoperative management program, such as advanced emphysema or Alzheimer's disease;
* A medical condition that may result in patient death prior to study completion: unstable cardiac disease, active malignancy;
* Pregnant;
* Current or recent alcohol and/or drug abuser requiring intervention;
* Signs of being geographically unstable, such as recent or pending divorce, or high level of job dissatisfaction.
Influence of Thoracolumbar Proprioceptive Support in the Segmental Stabilization Training

Proprioceptive training has been shown to be effective in increasing the efficiency of motor-sensory tissues that stabilize the trunk. The investigators hypothesis is that proprioceptive support do influence in the activation of the transversus abdominis muscle (TrA) during segmental stabilization training.


Eligibility Criteria:
Inclusion Criteria:

* healthy subjects

Exclusion Criteria:

* subjects with any kind of disease
Milking of the Cut-Cord During Resuscitation of Preterm Infants (The MOCC Study)

In this feasibility study, the investigators will randomize preterm infants born at \<32 weeks gestation to either the standard practice of delayed cord clamping (DCC) for 30-60 seconds at birth or milking of the long-cut cord (MOCC) while providing resuscitation/stabilization to the infant. The main objectives of the trial are to assess the feasibility of the new approach (MOCC) and to compare the two groups regarding the hemoglobin levels on admission to NICU in addition to neonatal morbidity and mortality.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \<32 weeks' gestation

Exclusion Criteria:

* Clinical evidence of interrupted placental circulation (placental abruption or avulsed cord) or bleeding from placenta previa.
* Monochorionic twins or any higher order multiple pregnancy
* Major fetal congenital or chromosomal abnormality
* Documented fetal anemia or in utero red blood cell transfusion
* Intent to withhold or withdraw treatment of the infant
Daclizumab Experience in Pediatric Heart Transplant

The purpose of this study is to examine the outcomes of those who have received Daclizumab as part of their immuno-suppression protocol following heart transplantation. Literature suggests that the time to first rejection episode can be avoided or delayed by using induction therapy.

In August 2005 the heart transplant team at Children's Healthcare of Atlanta began a protocol of Daclizumab 1mg/kg IV every two weeks for 5 doses; 1st dose to be received in the operating room following discontinuation of cardiopulmonary bypass.

Since one year has passed following initiation of this practice, it is necessary to review this immuno-suppression strategy and determine if, in fact, there was clinical benefit of reducing rejection without increasing the vulnerabilities of the immuno-compromised host.

We wish to review all heart transplant recipient records between August 1, 2004 and October 15, 2006. Historically, Children's has done approximately 10 transplants per year; therefore, we will review approximately 15 charts at Children's Healthcare of Atlanta and Sibley Heart Center Cardiology.

Eligibility Criteria:
Inclusion Criteria:

* Status post heart transplant
* Age 0-21 years
* Received Daclizumab as induction therapy

Exclusion Criteria:

* Those who do not meet inclusion criteria
Controlled Release Nifedipine and Valsartan Combination Therapy in Patients With Essential Hypertension

The primary objective of this study is to investigate incremental cost effectiveness of Nifedipine CR and Amlodipine in combination therapy with Valsartan for the treatment of essential hypertensive patients.

To investigate incremental cost effectiveness, primary variables are mean treatment cost and achievement rate to target blood pressure level at the end of double-blind treatment period.


Eligibility Criteria:
Inclusion Criteria:

Untreated patients or patients with previous treatment by antihypertensive agents whose blood pressure at sitting position at the time of the entry (Visit 1) is:

* SBP\>/=160mmHg or DBP\>/=100mmHg for untreated patients (SBP Systolic blood pressure, DBP Diastolic blood pressure)
* SBP\>/=150mmHg or DBP\>/=95mmHg for patients with previous treatment by antihypertensive agents

Exclusion Criteria:

* Patients whose blood pressure on either day of Visit 1 or 2 is: SBP \> 200mmHg or DBP \> 120mmHg.
* Patients with secondary hypertension or hypertensive emergency such as malignant hypertension.
* Patients with a history of cardiovascular or cerebrovascular ischemic event (stroke, transient ischemic attack, myocardial infarction or unstable angina) within six months prior to the study.
* Patients with a history of intracranial or subarachnoid hemorrhage within six months prior to the study.
* Patients with uncontrolled diabetes (HbA1c \>/=8%)
* Patients with bradycardia or tachycardia (\<50 bpm, \>/=100 bpm), arrhythmia such as atrioventricular block (second and third degree), sinoatrial block or atrial fibrillation.
Refractory Status Epilepticus Treatment: Quality and Efficacy of Coma Induction

This study is to investigate the effects of different treatment characteristics regarding the use of intravenous anesthetic drugs (IVADs) as a rescue treatment for refractory Status epilepticus (RSE) on course and outcome. A retrospective data extraction from the digital medical records, the electroencephalographic and microbiologic database of all consecutive adult patients with Status epilepticus (SE) admitted to the University Hospital Basel is undertaken.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed SE between 2005 and 2019 who have been treated at intensive care units (ICUs) of the University Hospital of Basel

Exclusion Criteria:

* Patients with repetitive epileptic seizures not qualifying for SE or RSE
* Patients with documented refusal of the general in-house consent
Utilizing Activity Trackers to Promote Physical Activity in People With Epilepsy: Can we Make a Difference?

The purpose of this study is to evaluate standard of care exercise education alone or in combination with a wearable physical activity tracker in people with epilepsy (PWE) to determine the most effective way to increase physical activity and measure impact on depression, anxiety, quality of life, sleep, and seizure frequency.


Eligibility Criteria:
Inclusion Criteria:

* patient of the Texas Comprehensive Epilepsy Program at UTHealth-McGovern Medical School
* diagnosis of epilepsy
* be able to provide consent in English
* complete surveys independently
* be able to sync Fitbit data

Exclusion Criteria:

* currently using a wearable physical activity tracker prior to enrollment
* pregnant or planning to become pregnant during the study duration
* planning to undergo epilepsy surgery during the study duration