cyrilzakka/clinical-trials huggingface dataset:
Impairment in Glucose Homeostasis Among Obese Adolescents in High Risk Diabetes Prone Population - Jisr Az-Zarqa Village

Obesity is increasing all over the world in adults, adolescents and children,and is followed by morbidity, including the metabolic syndrome.

Hypothesis: Among obese adolescents there is a subgroup with impaired glucose homeostasis

The aim of the study is to identify adolescents with impaired glucose metabolism, 12-18 years, among high risk diabetes prone population, for diagnosis and treatment.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of obesity

Exclusion Criteria:

* History of disease or drug therapy affecting glucose metabolism
A Phase II Randomized, Double-blind, Placebo-controlled Study to Evaluate the Safety and Efficacy of Exosomes Overexpressing CD24 to Prevent Clinical Deterioration in Patients With Moderate or Severe COVID-19 Infection

A Phase II Randomized, double-blind, Placebo-controlled Study to Evaluate the safety and efficacy of exosomes overexpressing CD24 to prevent clinical deterioration .The study population will include patients with moderate or severe COVID-19 infection and laboratory markers predictive of the cytokine storm from the Corona department of each site, who have provided an informed consent.

155 patients will be randomized in a 2:1 ratio to receive either 1010 exosome particles (103 patients) or placebo (52 patients).The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days.

Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.

The exosomes will be diluted in 4ml normal saline for inhalation, administered once daily (QD) for 5 days.

Placebo (saline) will be prepared for inhalation and administered in the same manner as the exosomes.

Study treatments will be given as add-on to standard of care. Following the 5 days of treatment, patients will remain in follow-up for 23 additional days. Patients who will be discharged before the end of the 5-day treatment period will continue to receive treatment at home. Treatment administration and the study assessments will be carried out by the research personnel at the home of the patient, implementing the required protective measures.

On Day 28, when the isolation period is completed, these patients will arrive at the study site for the follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

1. A COVID-19 diagnosis confirmed with a SARS-coV-2 viral infection positive polymerase chain reaction (PCR) test
2. Age 18-80 years
3. Severity of disease according to the following criteria (at least one clinical parameter and one laboratory parameter are required):

   a. Clinical and Imaging-based evaluation i. Respiratory rate \> 23/min and \< 30/min ii. SpO2 at room air ≤94% and ≥90% iii. Bilateral pulmonary infiltrates \>50% within 24-48 hours or a severe deterioration compared to imaging at admission b. Evidence of an exacerbated inflammatory process i. LDH score\> 450 U/L ii. CRP \>50 mg/L iii. Ferritin \>1650 ng/ml iv. Lymphocytes \>800 cells/mm3 v. D-dimers \>1 mcg/ml
4. Willing and able to sign an informed consent

Exclusion Criteria:

1. Age\<18 years or \>80 years
2. Any concomitant illness that, based on the judgment of the Investigator is terminal
3. Ventilated patient
4. Pregnancy (positive urine pregnancy test \[women of childbearing potential only\]) or breastfeeding
5. Patients with Immunodeficiency (eg, CLL, HIV, rituximab therapy)
6. Unwilling or unable to provide informed consent
7. Participation in any other Interventional study in the last 30 days
Goal Directed Fluid Management Based on Non-invasive Monitoring

The purpose of this study is to evaluate whether goal directed fluid management using respiratory variations in the oxygen saturation by pulse oximetry (SpO2) waveform has potential to decrease postoperative complications and outcomes.

The aim of this study is to test the hypothesis that monitoring and minimizing the respiratory variations in the pulse oximeter waveform amplitude by volume loading has potential to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery.

In this study the investigators will test the impact of hemodynamic optimization based on the respiratory variations in the plethysmographic waveform amplitude to decrease postoperative morbidity and length of stay in the hospital in patients undergoing routine, moderate-risk elective surgery. The primary outcome variable is the incidence of postoperative complications. Secondary outcome variables are the duration of hospital and ICU stays, postoperative mortality, and cost of surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients (male or female)
* Over 18 years old undergoing non-cardiac surgery
* Weight \> 40 kg, Body Mass Index \< 40

Exclusion Criteria:

* Patients who do not consent
* Body Mass Index \> 40
Diagnosis of Acute Appendicitis, Ovary Torsion and Inflammation, and Testicular Torsion and Inflammation by Infrared Thermography

Thermal, or infrared, energy is the part of electromagnetic radiation that an observer perceives as heat. Infrared thermography allows us to visualize temperature distribution of the human body and has been used in medical practice since the 1950s. In current study we would like to examine the ability of infrared thermography to detect acute appendicitis, ovary torsion and inflammation, and testicular torsion and inflammation.


Eligibility Criteria:
Inclusion Criteria:

* \< 18 years old

Exclusion Criteria:

* \> 18 years old
MMR Vaccination Among HIV-infected Adults

This is a prevalence study of protective antibodies to measles, mumps, and rubella (MMR) in HIV-infected adults and HIV-uninfected controls. MMR vaccination were provided to both groups who had no protective antibodies to at least one of the three viruses.

From July to August 2011, 500 HIV-infected and 132 HIV-uninfected participants those met the eligibility criteria were enrolled and tested for protective antibodies to measles, mumps, and rubella.

All participants who had no protective antibody to at least one of the three viruses were recruited to vaccinate for MMR vaccine. Between June to September 2012, 249 HIV-infected and 46 HIV-uninfected adults were vaccinated. Antibodies to MMR were measured at week 8-12, and week 48 after vaccination, which were completed in August 2013. The results were ready for analysis in March 2014.

Eligibility Criteria:
Inclusion Criteria:

For HIV-infected participants, inclusions criteria were

1. 20-59 years old, ability to provide informed consent
2. receiving cART
3. CD4 cell count ≥200 cell/mm3 within 6 months before enrollment
4. plasma HIV-1 RNA \<50 copies/mL, and 5) ability to provide informed consent.

Exclusion Criteria:

For both groups

1. pregnancy or lactating
2. receiving cancer treatment, organ transplantation, ≥0.5 mg/kg/day of prednisolone or equivalent, or immunomodulating treatment
3. impaired renal function (creatinine clearance \<30 mL/min)
4. impaired liver function as defined by Child-Pugh C.
TAP-Block in Abdominal Aortic Surgery

The primary outcome of this study was the evaluation of the efficacy of TAP block on pain intensity following open abdominal aortic surgery.


Eligibility Criteria:
Inclusion Criteria:

* Open abdominal aortic surgery (aneurysm or aortobifemoral bypass)
* Person who has given his written consent

Exclusion Criteria:

* Emergency surgery
* Patient with infection
* Use of opioids in the long term
* History of chronic pain
* Higher functions incompatible with the functioning of the PCA
* Patients under guardianship
The Role of Inflammation in AMD and Related Disorders

This prospective, non-therapeutic study will compare the relative utility of multiple ocular imaging modalities in the detection of the cellular immune response in patients with AMD and related disorders.


Eligibility Criteria:
Inclusion Criteria STUDY EYE

Any tentative clinical diagnosis of the following:

1. Early dry AMD (drusen) with clinical suspicion of CNV
2. Late dry AMD (GA) with clinical suspicion of CNV
3. Reticular Pseudodrusen with clinical suspicion of CNV
4. Polypoidal choroidal vasculopathy
5. Retinal Angiomatous Proliferation
6. Central Serous Retinopathy
7. RPE detachment
8. Conversion to wet AMD (CNV)
9. Decade matched controls

Inclusion Criteria CONTROL EYE

* Subjects \> 18 years of age
* Best corrected visual acuity (BCVA) of 20/32 or better

Exclusion Criteria STUDY/CONTROL EYE:

* Patients not able to provide consent for the study.
* Patients with a poor view of the fundus due to cataract or vitreous hemorrhage.
* Patients \< 18 years of age
* Patients with known allergy to angiographic dye
* Patients with any concurrent unrelated eye diagnosis that would interfere with image acquisition or interpretation (eg advanced diabetic retinopathy, vascular occlusion, uveitis, or others).

Exclusion Criteria CONTROL EYE

* Suspect diagnosis of AMD, RPD, PCV, RAP, CSR or RPED
* Family history of AMD
* 2 or more large drusen (\>125um) or 20 or more medium drusen (64-124um)
* Diabetes
* Patients using Plaquenil/Chloroquine/Hydroxychloroquine
* Diagnosis of inflammatory disease
* Patients with inherited eye disease
* Note: patients with a diagnosis of nevi are NOT excluded from this study
JNT Versus TNT to Guided OGT-overlap Oesophagojejunostomy

Gastric/gastroesophageal junction (G/GEJ) cancer patients who underwent laparoscopic total gastrectomy (LTG) were eligible for this study

All patients enrolled in our study underwent standard laparoscopic total gastrectomy (LTG) with D2 lymphadenectomy and OGT-overlap oesophagojejunostomy according to the Japanese Gastric Cancer Association treatment guidelines and our previous reports. When the surgeons decided to perform OGT-overlap oesophagojejunostomy after gastrectomy, we randomised the patients into the Traditional Decompression Nasogastric Tube (TNT) group or Joint Nasogastric Tube (JNT) group by simple randomization operatively.

In the TNT group, the TNT was put into the oesophageallumen from the nose, to guide the cutting of a small enterotomy on the posterior oesophagealstump . While in the JNT group, the JNT was used to substitute the TNT. After the anastomosis was completed, the team of surgeons performed an intraoperative gastroscopy to check for defects, bleeding, and stenosis in the anastomosis, and esophageal pseudocanals, and also to confirm whether the esophageal mucosa was damaged by TNT or JNT.

Eligibility Criteria:
Inclusion Criteria:

(1) Age 18-75 years; (2) Physical status score (ECOG) 0-2 points; (3) Preoperative pathological examination to diagnose gastric/gastroesophageal junction (G/GEJ) cancer; (4)No obvious contraindications for surgery; (5)Did not found metastasis preoperatively and intraoperatively; (6)Confirmed tumours invade oesophagus no more than 3cm intraoperatively; (7) Expected to perform OGT-overlap oesophagojejunostomy after lymphadenectomy and gastrectomy in the operation of laparoscopic total gastrectomy.

Exclusion Criteria:

(1)Underwent radiotherapy for G/GEJ cancer preoperatively; (2) continuous HIPEC after operation.
Clinical Trial on the Effects of Caffeine and Taurine From Energy Drinks (EDs) to Parameters of the Cardiovascular System in Humans

The aim of this study is to examine the safety and the effects of EDs at high doses, either alone or in combination with other risk factors such as alcohol intake, physical exercise and sleep deprivation, on cardiovascular markers and subjective health.


Eligibility Criteria:
Inclusion Criteria:

* written informed consent
* healthy (no acute or chronic desease)
* BMI 20,0 - 25,9 kg/m2
* moderate and non-regular consumption of alcohol, EDs and coffee

Exclusion Criteria:

* pregnancy
* regular medication (oral contraceptives permitted)
* hypertension and other deseases of the cardiovascular system
* liver-deseases
* psychiatric deseases
* epilepsy
* other relevant deseases
* (former) alcoholics
* non-compliance to the study-protocol
* simultaneous participation in another clinical trial
* retraction of the written informed consent
Prematurity at the Limit of Viability

Advancements in perinatal care have significantly improved the survival of extremely premature infants, establishing a viability threshold below 25 weeks' gestational age (GA). However, management at the limit of viability poses ethical and decision-making problems for health-care professionals. They grapple with the delicate balance between potential survival and long-term disabilities.

These decisions, as well as the information given to families, are based on knowledge of the prognosis as assessed by national and international epidemiological studies. Healthcare professionals rely on population-based estimations but face discrepancies in predicting outcomes because there are significant variation depending on perinatal center and country where infants are hospitalized. In the large French epidemiological study, 9,6% of livebirths included were born at 22-25 wks and only 38% survived.

In the neonatology department of the croix rousse, these infants have been actively cared for for many years, which has allowed the development of specific skills that are essential for the proper management of these very high-risk patients. Furthermore, EPIPAGE 2 included data from centers where perinatal management was probably not very active at these extreme ages. It results in worse neonatal outcomes as evaluated at the national level than outcomes data evaluated at the neonatal intensive care unit of Croix-Rousse hospital. Using data from EPIPAGE 2 study for clinical decision could lead to avoid active care at the for some infants at the limit of viability It is needed to obtain complete evaluation of neonatal outcomes of infants hospitalized at the Croix-Rousse hospital, so that clinicians may rely on actualized data related to the practices in their perinatal center. It is also needed to compare outcomes with data from large national and international cohorts, to identify and quantify differences. Data about later neurodevelopment outcomes, at 2 years, are also needed as it can taken in consideration in decision-making process.


Eligibility Criteria:
Inclusion Criteria:

* Infants born between 22 and 25 weeks gestational age
* Infants hospitalized at the tertiary care neonatal unit of Croix-Rousse hospital
* Infants born between January 2010 and December 2019

Exclusion Criteria:

- None
The Role of Trans-spinal Direct Current Stimulation (tsDCS) in Treating Patients With Hand Spasticity After Stroke

The purpose of this study is to evaluate if 5 consecutive sessions of PathMaker anodal DoubleStim treatment, which combines non-invasive stimulation of the spinal cord (tsDCS- trans-spinal direct current stimulation) and of the median nerve at the peripheral wrist (pDCS-- peripheral direct current stimulation), can significantly reduce spasticity of the wrist and hand after stroke.


Eligibility Criteria:
Inclusion Criteria:

1. First single focal unilateral hemisphere lesion with diagnosis verified by brain imaging (MRI or CT scans) that occurred at least 6 months prior
2. Cognitive function sufficient to understand the experiments and follow instructions
3. A Modified Ashworth Scale score between 1-3 points for wrist flexor and extensor muscles
4. A minimum of 15 degrees wrist passive range of motion (ROM) for wrist flexion and extension from wrist neutral position

Exclusion Criteria:

1. Focal brainstem or thalamic infarcts
2. Prior surgical treatments for spasticity of the upper limb
3. Ongoing use of central nervous system (CNS)-active medications
4. Ongoing use of psychoactive medications, such as stimulants, antidepressants, and anti-psychotic medications
5. Botox or phenol alcohol treatment within 12 weeks of enrollment
6. Pregnancy in women, as determined by self-report
7. History of spinal cord injury or weakness
8. Chronic pain
9. Peripheral neuropathy including insulin dependent diabetes as determined by case history
10. Presence of additional potential tsDCS risk factors:

    * Damaged skin at the site of stimulation (i.e., skin with ingrown hairs, acne, razor nicks, wounds that have not healed recent scar tissue, broken skin, etc.)
    * Presence of an electrically, magnetically or mechanically activated implant (including cardiac pacemaker), an intracerebral vascular clip, or any other electrically sensitive support system
    * Highly conductive metal in any part of the body, including metal injury to the eye (jewelry must be removed during stimulation)
    * Past history of seizures or unexplained spells of loss of consciousness during the previous 36 months
36-Month Post-marketing Surveillance and Analysis of Menactra Vaccine in 2-10 Year Olds

To further characterize the safety profile of Menactra vaccine and to identify any signals of potentially vaccine-related adverse events (AEs) not detected during pre-licensure studies.


Eligibility Criteria:
Inclusion Criteria:

* Receipt of Menactra vaccine during the study period.

Exclusion Criteria:

* None
Hypotension Prediction Index: Correlations Between Invasive and Non-invasive Pressure Points.

To evaluate the clinical performance of the Hypotension Prediction Index obtained from the continuous, non-invasive Clear Sight monitor.

To evaluate the clinical performance of the Hypotension Prediction Index obtained from the continuous, non-invasive ClearSight monitor.

Eligibility Criteria:
Inclusion Criteria:

* All Patients 18 years or older undergoing surgery with the use of general anesthesia and with planned arterial catheter placement and use of the HPI monitor.

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults ( infants, children teenagers)
* Pregnant Women
* Prisoners
Study of Effects of Light on the Vigilance and Cognitive Performance Following a Night Without Sleep

Sleep disorders are a major public health issue, affecting 1 in 6 French. The medical impact at the individual level but also social and economic level (loss of productivity, morbidity, mortality) emphasize the need for one hand, to improve the investigators' understanding of these disorders in order to develop appropriate therapeutic tools and on the other hand, to increase the investigators' support abilities of patients with these disorders.

The investigators' team of unity sleep from Strasbourg University Hospitals, in collaboration with the UPR 3212 CNRS team, is working on the development and adjustment of new concepts and tools to compensate the investigators' sleep debt in order to apply them to patients with sleep disorders and persons who face with sleep restriction.


Eligibility Criteria:
Inclusion Criteria:

* Man or woman
* Age from 18 to 40 years
* With a Body Mass Index (BMI) between 17 and 30 kg m-2
* Healthy volunteer determined by clinical examination and psychological interview
* Agreeing to abstain from caffeine, nicotine, alcohol, psychotropic drugs, cannabis or other drugs, the week before the start of Stage 2 of the study until the end of the study
* Dated and signed informed consent
* Subjet affiliated to a social security scheme
* Subject has been informed about the results of the medical examination

Exclusion Criteria:

* Participation in other clinical trials in the month preceding the inclusion
* Shift work in the year before inclusion
* Cons-indications to the use of the medical device
* Ocular disease
* Unable to give informations to the subject (subject in an emergency situation, difficulties in understanding, ...)
* Subjet under judicial protection
* Subject under guardianship or curatorship
* pregnancy
* breastfeeding
Vaginal Delivery Debrief Checklist to Improve Team Communication

This study is to determine if using a standardized debrief checklist after vaginal delivery improves communication between the vaginal delivery health care team members and if using the checklist increases a sense of enhanced communication between team members.

This is a study for providers who are a part of the health care team involved with vaginal delivery of newborns. A checklist has been developed that may improve communication between team members following birth. The goal of this study is to evaluate whether the checklist improves or enhances team member communication.

Eligibility Criteria:
Inclusion Criteria:

* Registered Nurses (RNs) and Licensed Practical Nurses (LPNs) in the Women's and Children's Services Department who attend vaginal deliveries as well as providers who attend vaginal deliveries at Providence St Peter Hospital Family Birth Center in Olympia Washington (WA).

Exclusion Criteria:

* None
Study to Evaluate Safety, Tolerability and Immunogenicity of Vaccine (UB 311) in Subjects With Alzheimer's Disease

The purpose of this Phase I study is to determine whether the vaccine (UB 311), targeting the amyloid beta peptide (N-terminal amino acids, 1-14), is safe and immunogenic in patients diagnosed with mild or moderate Alzheimer's disease (AD). Amyloid beta was selected as the target antigen based on supporting evidence of the hypothesis that places the accumulation of amyloid beta at the initiating step of AD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of mild to moderate Alzheimer's Disease
* Mini-Mental State Examination (MMSE) 15-25
* Other inclusion criteria apply

Exclusion Criteria:

* Major psychiatric disorder
* Severe systemic disease
* Serious adverse reactions to any vaccine
* Other exclusion criteria apply
Safety and Pharmacokinetics/Pharmacodynamics of SHR3824 in Patients With Hepatic Impairment

Comparison of the pharmacokinetics/Pharmacodynamics of the SHR3824 in Patients With Mild, Moderate and Severe Hepatic Impairment Compared with Healthy Volunteers.


Eligibility Criteria:
Inclusion Criteria:

* 18 years to 75 years (inclusive)
* Body mass index should be between 18 and 33 kg/m2 (inclusive) (ie, a measure of one's weight in relation to height)
* Liver damage due to viral hepatitis, alcoholic liver disease, autoimmune hepatitis, primary biliary cirrhosis of the liver (except for patients with drug-induced liver injury)

Exclusion Criteria:

* allergic to SGLT2 inhibitor analogues or any other similar structure;
* lactose intolerance history or lactose intolerance;
* Suspected or diagnosed as liver cancer or with other malignant tumors;
* Alcoholic liver, autoimmune liver disease, liver transplantation history
A Study to Determine the Pharmacokinetics, Pharmacodynamics, and Tolerabiltiy of Betrixaban in Patients With Mild, Moderate, and Severe Renal Impairment

The purpose of the study is to compare the pharmacokinetics, pharmacodynamics, and tolerability of betrixaban in patients with mild, moderate, and severe renal impairment to healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Able to understand and sign the written informed consent.
* Subjects should have either normal renal function or have stable renal disease

Exclusion Criteria:

* Subjects require dialysis
* Evidence of active bleeding or bleeding disorder
* Unstable or clinically significant other disorders such as respiratory, hepatic, metabolic, psychiatric or gastrointestinal disorder
Tobacco Pilot Study for Low Income Smokers

Pilot study to test feasibility of delivering a motivational smoking cessation intervention to low income smokers via a computer tablet.

Twenty Salvation Army clients will be recruited to pilot test a motivational smoking cessation counseling intervention that is delivered via a tablet computer. Study participants will be given brief instructions on how to use the tablet. They will then complete a brief survey on the tablet. This will be followed by the researcher using the tablet to provide the motivational intervention. Finally, study participants will be interviewed to establish this perceptions of the intervention.

Eligibility Criteria:
Inclusion Criteria:

* current smoker (≥ 10 cigarettes/week for the past six months who are not currently trying to quit)
* age ≥ 18 years
* English speaking/writing

Exclusion Criteria:

* not receiving services for the Salvation Army