cyrilzakka/clinical-trials huggingface dataset:
Study of the Role of Pomegranate Juice Ellagitannins in the Modulation of Inflammation in Inflammatory Bowel Disease

The aim of this research is to study the effects of a pomegranate juice on calprotectin levels in patients suffering of inflammatory bowel disease (IBD) in clinical remission. Fecal calprotectin levels, surrogate marker of mucosal inflammation, will be measured from baseline to 12 weeks later (end of intervention). Systemic and mucosal changes of biochemical and molecular inflammatory response markers will be also assessed.

The main purpose of the intervention trial is to assess the possible effect of pomegranate juice consumption on reducing fecal calprotectin (FC) levels in volunteers suffering from IBD with a high risk of clinical relapse. In detail, the objectives of this intervention are as follows: (i) assessing the changes in FC levels in the two groups (active treatment, control) from baseline to 12 weeks later (primary outcome); (ii) investigating the systemic and mucosal modifications of selected biochemical and molecular inflammatory response markers in the two groups after 12 weeks of the intervention compared with baseline (secondary outcomes); (iii) evaluating circulating and urinary ellagitannin-derived metabolites from regular pomegranate juice consumption in the two groups before and after the intervention.

The detailed study protocol is published in the Trials journal.

Eligibility Criteria:
Inclusion Criteria:

* Patients with Ulcerative Colitis (diagnosed on the base of clinic, endoscopic, and histologic criteria) in clinical remission (SCCAI = 0) from at least three months and in stable therapy (without therapeutic modifications in the three previous months) with mesalazine, immunomodulators and/or biologics.
* Patients affected by Crohn's Disease, particularly involving sigmoid colon and rectum (diagnosed on the base of clinic, endoscopic, and histologic criteria) in clinical remission (CDAI \< 150) from at least three months and in stable therapy (without therapeutic modifications in the three previous months) with mesalazine A, immunomodulators and/or biologics.
* Fecal calprotectin at baseline ≥ 100 microg/g.
* Signed informed consent.

Exclusion Criteria:

* Patients affected by Ulcerative Colitis and Crohn's Disease with severe endoscopic disease activity (Ulcerative Colitis: Mayo Endoscopic Score = 3; Crohn's Disease: Simple Endoscopic Score SES-CD \> 15).
* Patients on steroid therapy in the two previous months.
* Patients in therapy with warfarin or other anticoagulants.
* Known or supposed hypersensitivity to fruit and/or juice of pomegranate.
* Women in fertile age which refuse to use contraceptives specified in the study (oral contraception, IUD) and breastfeed women.
* Diabetic patients and other patients with severe clinical conditions which the investigator consider to contraindicate patient participation at the study.
* Therapy modifications and/or assumption of experimental therapies within three months before the study inclusion.
A Clinical Trial Designed to Evaluate the Safety and Efficacy Study of Luminate® in Inducing PVD (Posterior Vitreous Detachment) in Non-Proliferative Diabetic Retinopathy

A Phase 2, Randomized, Double-masked, Placebo-controlled Multicenter Clinical Trial Designed to Evaluate the Safety and Efficacy of Luminate in Inducing PVD in Subjects with Non-Proliferative Diabetic Retinopathy.


Eligibility Criteria:
Inclusion Criteria:

1. Non-Proliferative Diabetic Retinopathy Subjects of any grade
2. Subjects with either a) no PVD, b) stage 1 PVD or c) stage 2 PVD at baseline by b-scan in the study eye
3. Subjects that are at least 45 years of age
4. Subjects that are free of other significant retinal pathologies that could interfere with the measurements or conduct of this study
5. Intraocular Pressure under control, IOP 30 mm or less
6. Male or female subjects
7. Signed Informed Consent -

Exclusion Criteria:

1. No media opacities or abnormalities that would preclude observation of the retina or performance of any study related imaging tests
2. History of prior vitrectomy in the study eye
3. Subjects with epiretinal membranes, vitreomacular adhesion, vitreomacular traction, or macular holes in the study eye at baseline
4. Subjects with proliferative DR, neovascular AMD, or retinal vascular occlusion in the study eye
5. Subjects with clinically significant macular edema in the study eye
6. Subjects with a history of focal/grid or pan-retinal laser photocoagulation in the study eye
7. Subjects likely to need intraocular surgery, laser treatment, or non-study intravitreal injections in the study eye during the study period.
8. Subjects with history of retinal detachment in the study eye
9. High myopes with a spherical equivalent of \> -8.00 D spectacle correction in the study eye
10. Subjects with systolic BP\> 180 at screening
11. Subjects with HgA1c \>12.0 within 90 days preceding enrollment
12. Subjects that have chronic or recurrent uveitis
13. Subjects that have ongoing ocular infection or inflammation
14. Subjects with uncontrolled glaucoma, ie IOP \> 25mm with or without IOP lowering agents
15. Subjects that have contraindications to the study medication
16. Subjects who are unable to meet the extensive post-op evaluation regimen
17. Pregnant or nursing women
18. Subjects with a history of penetrating ocular trauma in the study eye
19. Subjects that are participating in another clinical research study
Acceptability of HPV Self-sampling Among Canadian Women Aged 21 to 65

We propose a cross-sectional study to explore the acceptability and feasibility of HPV self-sampling among Quebec women. The study will invite eligible women to self-sample for HPV at home. The HPV risk factors of patients included in the study will be taken into consideration (vaccination, smoking, number of partners, date of last screening, etc.).


Eligibility Criteria:
Inclusion Criteria:

* Speak and understand French without help

  * Have internet access (for completing forms)
  * Have a mailing address

Exclusion Criteria:

* Known positive HPV status • Have already had a hysterectomy
Assessing Cerebrovascular Reactivity Based on Cerebral Oximetry: a Pilot Study

The brain is such a metabolically active organ that it consumes about 20% of oxygen burned every minute by an average adult even though it only contributes about 2% of the body weight. As a result, the brain produces a disproportionately high amount of CO2 every minute in comparison with the rest of the body.

The researcher can use Diffuse Optical Spectroscopy Imaging, cerebral non-invasive oximetry instrument, to determine cerebrovascular reactivity during surgery procedure. Specifically, the cerebral tissue O2 saturation can measure by Diffuse Optical Spectroscopy Imaging can use for cerebral blood flow in the evaluation of cerebrovascular reactivity.

Adequate brain perfusion is critical not only to supply oxygen and nutrients but also to wash out metabolic end products including CO2. Blood flow depends on perfusion pressure and vascular bed resistance. It is well known that multiple physiological and pathological factors affect cerebral vasculature, and the resistance to blood flow. The cerebrovascular responsiveness to those factors determines how well the brain can maintain and adjust its perfusion.

Eligibility Criteria:
Inclusion Criteria:

1. Male or Female 20 years of age and older
2. Female non-pregnant
3. Subject scheduled for elective surgery under general anesthesia with intubation.
4. Subject who is able to give informed consent.

Exclusion Criteria:

1. Less than 20 years old of age
2. Pregnant woman
3. Subjects currently diagnosed with severe hypertension, myocardial ischemic disease, symptomatic valvular disease(s), symptomatic arrhythmia, uncompensated congestive heart failure, intracranial aneurysm.
Compare Outcomes of CPR Between the Video-laryngoscopy (VL) Users and the Direct-laryngoscopy (DL) Users

This is a clinical study based on the analysis of video-clip data of cardiopulmonary resuscitation (CPR) and clinical data for out of hospital cardiac arrest patients between 2011 and 2015. Aim of study is to compare the endotracheal intubation performance and CPR outcomes between videolaryngoscopy (VL) and direct laryngoscopy (DL) users.

Endotracheal intubation (ETI) has been considered to be the best method of airway management during cardiopulmonary resuscitation (CPR). However ETI during CPR is a highly skill-dependent procedure, then it should be attempted only highly trained physicians. Because of technical difficulty in using direct laryngoscopy (DL), various types of videolaryngoscopy (VL) devices using micro-camera technology have been designed to overcome the problems of DL.

This study tried to compare the recovery of spontaneous circulation (ROSC) and survival discharge between use of standard device (DL) and VL in a real clinical setting. In addition, this study also compare the first pass success rate of ETI,speed of ETI, incidences of complications, and chest compression interruptions during cardiopulmonary resuscitation between both device users.

Eligibility Criteria:
Inclusion Criteria:

* Patients who suffer sudden out-of hospital cardiac arrest

Exclusion Criteria:

* Cardiac arrests from multiple trauma
* Cases of requesting the do-not attempt resuscitation before ETI
* Intubated cases before arrival to emergency department
Safety & Tolerability of the IRay System in Subjects With Exudative Choroidal Neovascularization (CNV) Secondary to Age-Related Macular Degeneration (AMD)

The purpose of this study is to evaluate the safety and clinical feasibility of the IRay System for the treatment of wet age-related macular degeneration (AMD).

The primary objective is to evaluate the safety and clinical feasibility of stereotactic radiotherapy with the Oraya IRay system for the treatment of choroidal neovascularization (CNV) associated with age-related macular degeneration (AMD), as measured by incidence and severity of ocular radiation related serious adverse events (SAE) and adverse events (AE) in subjects treated with an 11, 16 or 24 Gray (Gy) macular dose through the 60-month follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be age 50 or older
* Women must be post-menopausal ≥1 year or surgically sterilized
* Subjects must have choroidal neovascularization lesion size of ≤11 total disc areas (28.26mm), and a greatest linear dimension of ≤6 mm
* Subjects must have Early Treatment Diabetic Retinopathy Study (ETDRS) best corrected visual acuity of 69 to 24 letters (20/40 to 20/320 Snellen Equivalent) in the study eye
* Subretinal hemorrhage (if any) must not comprise more than 50% of total lesion size, and may not involve the subfoveal space

Exclusion Criteria:

* Subjects with prior or concurrent therapies including submacular surgery, thermal laser photocoagulation (with or without photographic evidence), photodynamic therapy and transpupillary thermotherapy (TTT)
* Subjects with concomitant disease in the study eye, including uveitis, diabetic retinopathy,presence of RPE tears or rips, acute ocular or periocular infection
* Subjects with advanced glaucoma (\>0.8 cup to disk ratio) or intraocular pressure ≥30 mmHg in the study eye
* Previous glaucoma filtering surgery in the study eye
* Refractive error in the study eye demonstrating more than -8 diopters of myopia (or globe axial length ≥26 mm). For subjects who have undergone prior refractive or cataract surgery in the study eye, the preoperative refractive error cannot exceed -8 diopters of myopia
* Subjects with any retinal vasculopathies, including diabetic retinopathy, retinal vein occlusions, etc. in the study eye
Preliminary Safety and Efficacy of the PDS-1.0 in Patients With Neovascular Age Related Macular Degeneration (AMD)

This study will evaluate the preliminary safety and efficacy of PDS 1.0 in patients with neovascular AMD.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of CNV secondary to AMD confirmed by fluorescein angiography, not previously treated
* Retinal thickness due to edema of at least 300um in the study eye
* Best corrected visual acuity of 20/40 or worse in the study eye
* Best corrected visual acuity of 20/40 or better in the fellow eye

Exclusion Criteria:

* Evidence of scarring CNV (e.g. geographic atrophy) in the study eye
* Fibrosis \>75% of lesion area in the study eye
Impact of Home-based Cardiac Rehabilitation on Outcomes After TAVR

To evaluate the effects of a home-based cardiac rehabilitation program for Chinese patients after Transcatheter Aortic Valve Replacement (TAVR).


Eligibility Criteria:
Inclusion Criteria:

* Aortic stenosis accepted for TAVR
* Participant able and willing to give written informed consent
* Participant able (in the investigator's opinion) and willing to comply with all study requirements

Exclusion Criteria: subjects may not enter the study if any of the following apply

* Intervention deemed inappropriate due to co-morbidity or frailty
* Life expectancy less than one year due to co-morbidity
* Previous surgical aortic valve replacement (sAVR) or TAVR
* Predominant aortic regurgitation
Comparison Between Lidocaine, Dexmedetomidine, and Their Combined Infusion in Subjects Undergoing Coronary Artery Bypass Graft

The aim of the present study is to compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.

Lidocaine has been reported to have an antiarrhythmic and myocardial protective effect. A previous study has reported that low-dose lidocaine infusion can decrease the incidence of ventricular fibrillation and tachycardia during the first 24 hours after coronary artery bypass graft (CABG). A recent study also reported that the lidocaine infusion during CABG could decrease the myocardial injury by measuring the CK-MB and Troponin-I blood level.

Dexmedetomidine is an alpha-2 agonist and reduces the sympathetic tone and neuroendocrine stress response. Dexmedetomidine was reported to have a cardioprotective effect by a previous animal study. However, there was no clinical study evaluating the cardioprotective effect of dexmedetomidine.

Therefore, we are trying to evaluate and compare the antiarrhythmic and myocardial protective effect between lidocaine, dexmedetomidine, and their combined infusion in subjects undergoing coronary artery bypass graft.

Eligibility Criteria:
Inclusion Criteria:

* Those undergoing off-pump coronary artery bypass graft during the study period in Samsung Medical Center

Exclusion Criteria:

* Any patients with plasma aldosterone, or glucocorticoid disorder including primary hyperaldosteronism, renovascular hypertension, rennin-secreting tumor, salt-wasting renal disease, Cushing syndrome
* Patients with recent exogenous steroid administration or previous diuretics therapy
* Patients with recent myocardial infarction
* Those undergoing unplanned cardiopulmonary bypass during the surgery
Physiological Effects of Gastric Sleeve Operation

After gastric sleeve patients undergo a substantial weight loss, but the physiological mechanisms behind the weight loss is not fully elucidated. Studies suggest that gut-hormone secretion is altered comparable to what is also seen after Roux-en-Y gastric bypass, however to which extent is not fully established and furthermore, the mechanisms behind an altered secretion are unclear. The purpose of this study is to investigate absorption and postprandial metabolism of glucose and protein in addition to gut hormonal responses after gastric sleeve compared with a group of un-operated subjects machted on sex, age and BMI. Furter, a group of Roux-en-Y gastric bypass operated patients matched on pre-operative BMI, current BMI, sex and age will be included for comparison.


Eligibility Criteria:
SG ang RYGB group:

Inclusion Criteria:

* Uncomplicated RYGB or SG \> 12 month prior to inclusion
* Weight stable (+/- 3 month the last month)
* Written informed consent

Exclusion Criteria:

* Diabetes (HbA1c\>48 or Fasting plasma-glucose\>6.1 mM)
* Pregnancy and/or breastfeeding
* Inadequately treated thyroid disease
* Serious heart or respiratory illness
* Haemoglobin \< 6,5 mM.

Un-operated control group:

Inclusion Criteria:

* Written informed consent

Exclusion Criteria:

* Prior RYGB, SG or complicated upper gastrointestinal surgery
* Diabetes (HbA1c\>48 or Fasting plasma-glucose\>6.1 mM)
* Pregnancy and/or breastfeeding
* Inadequately treated thyroid disease
* Serious heart or respiratory illness
* Haemoglobin \< 6,5 mM.
Propofol Versus Dexmedetomidine for Prevention of Sevoflurane Agitation in Recipients of Living Donor Liver Transplantation

The use of propofol or dexmedetomedine for prevention of sevofurane emergence agitation in LDLT recipients


Eligibility Criteria:
Inclusion Criteria:

* All recipients of living donor liver transplantation

Exclusion Criteria:

* patient refusal Allergy to either propofol or dexmedetomediene CNS disease
Exergame on Sleep and Emotion Among Students

This study aims to investigate the feasibility and the potential efficacy of using Xbox 360 Kinect game among healthcare undergraduate students. Thirty-six participants will be recruited and randomly allocated into the intervention and control group. The session will be 30 minutes per session for three times per week. Two outcome measures will be used at pre and post intervention.

Sleep deprivation and emotional problems such as stress, anxiety and depression commonly occur in university students. Exercise is beneficial to ameliorate those problems however university students are not serious to uptake physical activity. Commercially available exergame such as Xbox 360 Kinect is one of the alternatives. This study aims to investigate the feasibility and the potential efficacy of using Xbox 360 Kinect game among healthcare undergraduate students. A pilot two-armed parallel randomized controlled trial was implemented. A total of 36 undergraduate students was recruited and randomly allocated into the intervention group (playing Xbox 360 Kinect) or the control group (continue with normal daily routine). The intervention group received 30 minutes of Xbox Kinect activity, three times per week for six weeks. Information on psychology (DASS-21) and sleep (FOSQ-30) status were collected at pre- and post-experiment. The researcher-developed feasibility questionnaire was given to the participants in the intervention group at post-experiment. Repeated-measures ANOVA analysis was used to investigate within-between group comparison and significant value was set at p≤0.05. The analysis found potential improvement on sleep (p=0.039) and psychological health (p=0.002-0.067). The intervention protocol is feasible and highly accepted by the participants. Required optimum amount of dosage, sample size and used of outcome measures are suggested from the findings. This pilot and feasibility study support the use of Xbox 360 Kinect games in practice and to be implemented for future research.

Eligibility Criteria:
Inclusion Criteria:

* Undergraduate healthcare students
* Able to read and understand English version questionnaire
* Having BMI \<25

Exclusion Criteria:

* Person with condition (i.e. asthma, heart problem) that prevent from participating in active physical activities.
* Known history of mental health issues
* Visually impaired students iv. Postgraduate students
Weight-Adjusted vs Fixed Low Doses of Low Molecular Weight Heparin For Venous Thromboembolism Prevention in COVID-19

Worldwide observational studies indicate a significant prothrombogenic effect associated with SARS-CoV-2 infection with a high incidence of venous thromboembolism (VTE), notably life-threatening pulmonary embolism.

According to recommendations for acute medical illnesses, all COVID-19 hospitalized patients should be given VTE prophylaxis such as a low molecular weight heparin (LMWH). A standard prophylactic dose (eg. Enoxaparin 4000IU once daily) could be insufficient in obese patients and VTE has been reported in patients treated with a standard prophylactic dose.

In COVID-19 patients, guidelines from several international societies confirm the existence of an hypercoagulability and the importance of thromboprophylaxis but the "optimal dose is unknown" and comparative studies are needed.

In view of these elements, carrying out a trial comparing various therapeutic strategies for the prevention of VTE in hospitalized patients with COVID-19 constitutes a health emergency.

Thus, we hypothesize that an increased prophylactic dose of weight-adjusted LMWH would be greater than a lower prophylactic dose of LMWH to reduce the risk of life-threatening VTE in hospitalized patients. The benefit-risk balance of this increase dose will be carefully evaluated because of bleeding complications favored by possible renal / hepatic dysfunctions, drug interactions or invasive procedures in COVID-19 patients.

This multicenter randomized (1:1) open-label controlled trial will randomize hospitalized adults with COVID-19 infection to weight-adjusted prophylactic dose vs. lower prophylactic dose of LMWH.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient hospitalized for a probable/confirmed COVID-19 infection (confirmed by serology/polymerase chain reaction or by radiologic signs of COVID-19 pneumonia in the setting of clinical and laboratory abnormalities suggestive of a SARS-CoV-2 infection)
* Signed informed consent
* Patient affiliated to the Social Security

Exclusion Criteria:

* Renal insufficiency with a GFR\<15 mL/min/1.73m²
* Acute kidney injury KDIGO3
* Prophylactic dose of low molecular weight heparin for more than 3 days
* Curative dose of low molecular weight heparin for more than 1 day
* Recurrent catheter/hemodialysis access thromboses
* ECMO required in the next 24h
* Contraindication to low molecular weight heparin
* High bleeding risk (e.g. uncontrolled severe systemic hypertension, recent major bleeding, disseminated intravascular coagulopathy, thrombocytopenia \< 75G/L)
* History of heparin-induced thrombocytopenia
* Contraindication to blood-derived products
* Impossibility to perform a doppler ultrasound of the lower limbs (e.g. above the knee amputation, severe burn injuries)
* Expected death in the next 48h
* Vulnerable subjects according to articles L. 1121-5, L. 1121-7 et L1121-8 of French Public Health Code
Impact of Preemptive Intravenous Ibuprofen on Intraoperative Analgesia in Third Molar Teeth

This study was planned to evaluate the analgesic efficacy of preemptive intravenous (iv) ibuprofen on pain occurring during and after the mandibular third molar surgeon


Eligibility Criteria:
Inclusion Criteria:

* Patients who are to be elected third molar tooth extraction
* Patients between the ages of 20-35
* Patients who are symptomatic
* Third molar tooth angular or horizontal settled patients

Exclusion Criteria:

* Patients who refuse to participate in the study
* Patients under 20 years old, over 35 years old
* Patients who are allergic to known non-steroidal anti-inflammatory drugs
* Pregnant patients
* Patients with severe liver failure,
* patients with severe renal insufficiency
The Optimal Sequential Therapy After Long Term Denosumab Treatment

This study intends to investigate whether Alendronate and Zoledronate can prevent bone mineral density loss after long-term treatment with Denosumab.

This study intends to use a randomized trial to test whether Alendronate and Zoledronate can avoid the risk of rapid bone loss after the withdrawal of Denosumab.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal women or men over 50 years old
2. Denosumab treatment for at least two years and less than three years (up to five doses).

Exclusion Criteria:

1. Estimated glomerular filtration rate \<35 ml/min.
2. Malignancy
3. Continuous steroid treatment, hormone therapy or other medical treatment affecting bone metabolism
4. Secondary osteoporosis
5. Metabolic bone diseases
6. Contraindications to ZOL
7. Patients older than 80 years old
8. Hypocalcemia