cyrilzakka/clinical-trials huggingface dataset:
Evaluation of the Extended Depth of Focus After Bilateral Implantation of Hydrophobic IOLs

This will be a prospective observational, ethics committee approved study where patients undergoing routine cataract surgery will have bilateral implantation of the intraocular lens (LuxSmart, Bausch \& Lomb). The device under investigation is CE-mark approved and commercially available. The device under investigation and all study products, including the devices used for the study examinations, will be used within the intended use specifications from the manufacturer. In addition, no invasive or other burdening examinations will occur for the patient.

Investigator is accredited and experienced cataract surgeon and researchers who have been involved in similar studies in the past.

The device under investigation LuxSmart (Bausch \& Lomb) is a hydrophobic, acrylic copolymer containing UV absorber intraocular lens (IOL). The IOLs will be implanted as part of the routine cataract surgery on patients suffering from cataract development.

In total 30 patients will be recruited for this first clinical experience and receive bilateral implantation of the LuxSmart. The maximum time between 1st and 2nd eye implantation is 30 days, some patients may receive bilateral implantation on the same day. However there will be a minimum of 1 week between the implantations in the first 10 patients.


Eligibility Criteria:
Inclusion Criteria:

* Cataractous eyes with no comorbidity;
* Calculated IOL power is within the range of the study IOLs;
* Male or female adults ages 50 years or older on the day of screening who have cataract(s) in one or both eyes;
* Regular corneal astigmatism ≤1.5D (measured by an automatic keratometry) in one or both eyes;
* Clear intraocular media other than cataract;
* Dilated pupil size large enough to visualize IOL axis markings postoperatively
* Availability, willingness, skills and cognitive awareness enough to comply with the follow-up/study procedures and study visits.
* Subjects able to read, understand and provide written Informed Consent Form on the Ethics Committee approved Informed Consent Form and provide authorization as appropriate for local privacy regulations.

Exclusion Criteria:

* Age of patient \<50 years;
* Regular corneal astigmatism \>1.5D (measured by an automatic keratometry) in both eyes;
* Irregular astigmatism;
* Subjects with diagnosed degenerative visual disorders (e.g. macular degeneration or other retinal or optic disorders) that are predicted to cause future acuity losses to a level of 20/30 or worse;
* Subjects with AMD suspicious eyes as determined by OCT examination;
* Subjects who may be expected to require retinal laser treatment during the course of the study or at a greater risk of developing cystoid macular edema;
* Previous intraocular or corneal surgery;
* Traumatic cataract;
* History or presence of macular edema;
* Instability of keratometry or biometry measurements;
* Advanced or decompensated glaucoma;
* Significant dry eye;
Effect of rhBNP on CMD in Patients With STEMI After PPCI

The target population of this interventional study was STEMI patients. Primary discussion: Early rhBNP reduces microcirculation obstruction in STEMI patients undergoing primary PCI

Direct percutaneous coronary intervention is the preferred reperfusion strategy for acute ST-segment elevation myocardial infarction. During the opening of infarct-related vessels, 5%-50% of patients showed slow flow or no reflow and other coronary microcirculation dysfunction, which aggravated myocardial injury and increased the incidence and mortality of heart failure. Studies have shown that recombinant human brain natriuretic peptide (rhBNP) can reduce reperfusion injury and reduce myocardial infarction area CMD. Prolonged ischemia leads to rapid depletion of intracellular ATP and tissue metabolic acidosis. Blood flow irrigation during reperfusion leads to decreased levels of ATP precursors, calcium overload in mitochondria, release of a large number of inflammatory factors and oxygen free radicals, which can lead to injury or death of myocardial and endothelial cells. rhBNP can enhance the activity of antioxidant enzymes, reduce the irreversible oxidative damage caused by free radicals to myocardium, reduce the myocardial infarction area during ischemia reperfusion, and may reduce the reperfusion injury and protect the viable myocardium.

Eligibility Criteria:
Inclusion Criteria:

* STEMI
* PPCI within 24 hours of symptom onset
* Target vessel QFR-MR\>250mm Hg\*s/m

Exclusion Criteria:

* claustrophobia
* Postoperative TIMI grade 0-1
* Pregnancy
Effects of Curcumin on Inflammation and Oxidative Stress in Pediatric Patients on Regular Hemodialysis: A Randomized, Double-Blind, Placebo-Controlled Pilot Study

* The study will be a randomised, double blinded, placebo controlled design.
* It will include 2 groups : trial group and placebo group
* Patients in both groups are children on regular hemodialysis
* The patients in the trial group will receive Curcumin capsule 1 gm for 3 months , and the placebo group will receive a placebo capsule for 3 months
* All patients will be evaluated clinically, and laboratory at baseline, at 3 months after end of supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Male or female pediatric patients with weight of at least 30 kilograms.
* Undergoing regular hemodialysis for at least 6 months.

Exclusion Criteria:

* Bleeding disorders.
* Chronic liver disease.
* Diabetes mellitus.
* Autoimmune diseases.
* Receiving drugs that are contraindicated, or have major interactions with curcumin, and can't be discontinued or replaced.
* Receiving corticosteroids, or immune-suppressants.
* Patients taking any antioxidant supplements including vitamin E, ascorbic acid, omega -3 fatty acid, or L-carnitine within 3 months prior to enrollment in our study.
Safety and Efficacy of the Penumbra™ System in Acute Middle Cerebral Artery (MCA) Stroke

Stroke prognosis is intimately related to reperfusion. Reperfusion in acute setting can be achieved with different strategies - varying from intravenous rtPA from mechanical thrombectomy. Recently, interventional approaches have been gaining attention and playing an increasing role in stroke care. However, no solid scientifical data is available to date. The investigators want do conduct a pilot trial to test if the use of the Penumbra™ System can improve clinical outcomes in a specific stroke setting.


Eligibility Criteria:
Inclusion Criteria:

* Patient enrolled in acute ischemic stroke protocol
* Up to 3,5h from symptoms onset
* Clinical findings compatible with middle cerebral artery syndrome
* Angiotomographic evidence of proximal middle cerebral artery occlusion

Exclusion Criteria:

* NIHSS \< 10
* Overt contraindication to thrombolysis or angiopgraphy
* Disagreement with informed consent term or refusal to participate
Efficacy of Combined Scaffolds and Sodium Hypochlorite in Regenerative Endodontics of Immature Teeth

The aim of the study is to evaluate the efficacy of combinations of different scaffolds (blood clot, platelet rich fibrin, collagen) and sodium hypochlorite concentrations (0.5%- 2.5%) in regenerative endodontics of immature non-vital anterior teeth clinically and radiographically using cone-beam computed tomography.

Patients will be divided randomly into six equal groups (n=8)

* Group I: BC scaffold and 0.5% concentration of NaOCl irrigant solution.
* Group II: BC scaffold and 2.5% concentration of NaOCl irrigant solution.
* Group III: PRF scaffold and 0.5% concentration of NaOCl irrigant solution.
* Group IV: PRF scaffold and 2.5% concentration of NaOCl irrigant solution.
* Group V: Collagen scaffold and 0.5% concentration of NaOCl irrigant solution.
* Group VI: Collagen scaffold and 2.5% concentration of NaOCl irrigant solution.

CBCT image will be obtained for baseline records after placement of the final resin restoration then the patients will be recalled after 6 months and 12 months for evaluating any changes in root length, root canal width, apex diameter and lesion size if present. The success rates for patients at each recall visit will be scored as follows

1. Score 0: Persistence of clinical and radiographic findings.
2. Score 1: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + no evidence of increased root dimensions.
3. Score 2: Absence of swelling, drainage and pain along with radiographic evidence of osseous healing + radiographic root development.

Eligibility Criteria:
Inclusion Criteria:

* • Patients, abarantly free from any systemic diseases that may hinder the normal healing process.

  * Maxillary traumatized or cariously exposed immature anterior teeth.
  * Clinical signs of pulp necrosis.
  * Radiographic evidence of incomplete root development based on an apical opening \>1 mm.

Exclusion Criteria:

* • Allergy to medication used in the procedure or any medical conditions that contraindicate endodontic treatment (eg, acute systemic disease and abnormalities in host defense).

  * Non-restorable tooth.
  * Radiographic evidence of root fracture.
  * Lack of patient and parent cooperation.
  * Teeth with vital pulps and complete root development.
  * Presence of periodontal pocket \> 4 mm.
Graphic Messages to Prevent E-Cigarette Use Among Black and Latino Adolescents

The aim of this study is to determine if graphic messages prevent future vaping use among African American and Latino adolescents. The images have been developed in a user-design model and include four main themes: health reward, financial reward, self-efficacy, and social norms. We will assess pre- and post-exposure reactions on likelihood of future vaping among African American and Latino adolescents.


Eligibility Criteria:
Inclusion Criteria:

* self-identify as African American/Black and/or Hispanic/Latino
* know how to read and speak English and/or Spanish
* have never used e-cigarettes
* have access to a device that will be able to connect to the online survey

Exclusion Criteria:

* not identifying as African American/Black and/or Hispanic/Latino
* using e-cigarettes
Evaluation of the Effects of Different Interventions on Glycemic Control in Newly-Diagnosed Type 2 Diabetic Patients

The purpose of this study is to investigate and evaluate the effects of different interventions (1.continuous subcutaneous insulin infusion,2.multiple daily injections, 3.anti-hyperglycemic agents) on glycemic control, B-cell function and the remission rate in newly-diagnosed type 2 diabetic patients.

ß-Cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects responsible for the development of hyperglycemia. With continuous presence of insulin resistance, progressive loss of ß-cell function is the crucial defect. Hyperglycemia has deleterious effect on β-cell function, which is partially reversible by adequate glycemic control. In newly diagnosed type 2 diabetic patients with severe hyperglycemia, 2 weeks continuous subcutaneous insulin infusion (CSII) can induce adequate glycemic control with improvement of β-cell function. Nearly half of the patients can maintain euglycemia longer than 12 months by transient CSII. The improvement of β-cell function, especially the restoration of the first-phase insulin response is related to sustained euglycemia in the newly diagnosed type 2 diabetic patients. But it is unclear whether any other interventions (such as oral hypoglycemic agents and multiple daily injections) inducing optimal glycemic control in a short period of time can have the same effect. As a multicenter, open-label, randomized, parallel-group study will be needed to further prove and clarify the findings.

Eligibility Criteria:
Inclusion Criteria:

1. informed consents be given before treatment
2. the newly-diagnosed type 2 diabetic patients
3. fasting blood glucose (FBG) level ranging from 7.0～16.7 mmol/L
4. age ranging from 25～70 years old
5. body mass index (BMI) ranging from20～35kg/m2
6. never be treated with any anti-hyperglycemic agents or anti-hyperlipidemic agents

Exclusion Criteria:

1. having any severe acute or chronic complications
2. renal dysfunction, blood creatinine≥150µmol/L
3. blood aminotransferase level rising up(more than 2 times of the normal level)
4. any severe cardiac disease including congestive cardiac failure, unstable angina and myocardial infarct in 12 months
5. serious hypertension (systolic pressure≥180mmHg and/ or diastolic pressure≥110mmHg)
6. chronic or acute pancreatic disease
7. severe systematic diseases or malignant tumor
8. allergic to the drugs using in the trial
9. any factors interfering the result
10. female patients incline to be pregnant
11. being treated with corticosteroid, immunosuppressing drugs or cytotoxic drugs
12. poor compliance
Evaluation of the Switch From the Original Infliximab to Its Biosimilar in Daily Practice at Cochin Hospital

The purpose of this study is to evaluate the effectiveness of the switch from the original infliximab ( REMICADE®) to its biosimilar (INFLECTRA®) in all the patients at Cochin hospital receiving REMICADE® for either a rheumatic, gastro-enterologic or ophthalmic condition

All patients managed in one of the departments of cochin Hospital who are receiving the original infliximab ( REMICADE®) from at least 4 months will be invited to continue to receive infliximab but using its biosimilar (INFLECTRA®)) at the same regimen (identical dose per infusion and interval between two infusions) than the previous one while receiving REMICADE®. The tolerability of the infusion will be recorded as well as the percentage of patients continuing INFLECTRA® after at least six months of its initiation.

Moreover, the infliximab serum level will be evaluated after the last infusion of REMICADE® and after the third infusion of INFLECTRA®. At the same time, anti-drug antibodies will be tested.

Finally for each of the underlying disease (e.g. rheumatoid arthritis, spondyloarthritis, Crohn's disease, uveitis,..), the maintenance of the efficacy of Infliximab will be evaluated according to the usual outcome measures of the activity of the disease

Eligibility Criteria:
Inclusion Criteria:

* Male or female over 18 year old
* Patient treated with REMICADE® in Cochin hospital
* More than 3 perfusions of REMICADE® before the switch to INFLECTRA®

Exclusion Criteria:

* none
Glutamine Effects in Burn Patients

The study is designed to evaluate the effect of parenteral glutamine supplementation on infection in burn patients.

Despite improvements in prevention and management, burn injury continues to represent a major threat to the health and welfare of people worldwide in all age groups. Even with early surgical intervention and aggressive antibiotic therapy, infectious complications are a major cause of death in severe burn injury, accounting for 75% of all deaths occurring after initial resuscitation.

It is proposed that one source of these infections is a translocation of gram-negative bacteria from the gut. However, this mechanism of bacterial translocation through the gut wall remains a controversial mechanism of infection in humans. In animal studies, it has been demonstrated that glutamine supplementation can decrease gut-derived bacterial translocation and improve outcomes from burn injury.

Whether this holds true in humans has to be evaluated by additional studies. A recent study concluded that glutamine supplementation reduces gram-negative bacteremia in burned patients but viewed itself as preliminary and suggested that more clinical trials are warranted to corroborate the study outcome.

Eligibility Criteria:
Inclusion Criteria:

* Age between 18-50 years.
* Total burn surface area of 20% - 60%.
* Expected length of stay in ICU \> 48 hr.
* Admission within 72 hrs of burn injury.
* Any thermal injury such as flame burns. Scald burns and contact burns.

Exclusion Criteria:

* Burn patients with hepatic failure.
* Burn patient with Severe renal failure (glomerular filtration rate (eGFR \<50 ml/min).
* Patients with inborn errors of amino-acid metabolism (e.g., phenylketonuria).
* Burn patients with pre-existing severe cardiac, pulmonary diseases.
* Burn patients with diabetes mellitus or cancer.
* Patients with metabolic acidosis (pH\<7.35).
* Electric burns.
Juvenile Justice Girls Randomized Control Trial: Young Adult Follow-up

This study is a young adult follow-up of 166 females who originally participated in an RCT during adolescence due to their involvement in the juvenile justice system.

Females under age 18 years old are the fastest-growing segment of the juvenile justice population and are at risk for negative co-occurring outcomes including drug abuse, HIV/STI risk, criminal behavior, and educational failure. As they enter young adulthood, this constellation of behaviors puts them at heightened risk for early parenthood and subsequent involvement in the child welfare system (for their parenting behaviors) and the adult corrections system (for criminal behaviors). Such system involvement is costly, and its prevention would be of great significance to public health; however, very little is known about factors leading to females' success/failure in young adulthood and factors that might prevent involvement in these two public systems. This study aims to further our understanding of the pathways to and the prevention of HIV/STI risk, drug use, and child welfare and adult corrections involvement by following-up 166 women who participated in two randomized intervention trials aimed at reducing delinquency during adolescence. In the original studies, juvenile justice girls who had been referred for out-of-home placement due to chronic delinquency were randomly assigned to services as usual or to Treatment Foster Care Oregon (TFCO, formerly known as MTFC). Efficacy of the intervention with this sample has been shown at 12- and 24-month follow-ups on criminal referral rates, days spent in locked settings, deviant peer associations, educational engagement, and pregnancy prevention. The investigators propose to examine the developmental pathways for these juvenile justice girls into young adulthood (ages 21-28 years) using innovative data collection and data analytic techniques, with foci on the long-term effects of TFCO, the mediators of young adult adjustment and child welfare/corrections involvement, and the cost effectiveness and cost avoidance of TFCO on these outcomes. The overarching aim is to identify potential targets for subsequent intervention. One in-person assessment is proposed with each female and her current romantic partner (if she has one); in addition, telephone interviews will be conducted every 6 months for the duration of the study, and system data from child welfare and adult corrections will be collected.

Eligibility Criteria:
Inclusion Criteria:

* female
* 13-17 years old
* at least one criminal referral in the prior year
* court-mandated placement in out-of-home care

Exclusion Criteria:

* Currently pregnant
A Study of Diabetic Patients With De Novo Native Coronary Artery Lesions

The main objective of this study is to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent in maintaining minimum lumen diameter in de novo native coronary artery lesions as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Both stents are mounted on the Raptorâ Rapid Exchange Stent Delivery System.

This is a multicenter (19 sites), prospective, 2 arm randomized study designed to assess the safety and effectiveness of the CYPHER sirolimus-eluting stent as compared to the uncoated Bx VELOCITY balloon-expandable stent in patients with manifest diabetes mellitus. Patients with de novo native coronary artery lesions \<= 42 mm in length and \>=2.5mm and \<=3.5mm in diameter (by visual estimate) will be included in the study. A total of 190 patients will be entered and randomly allocated to the CYPHERTM sirolimus-eluting stent or the uncoated Bx VELOCITY balloon-expandable stent at a 1:1 ratio. Patients will be followed for 12 months post-procedure, with all patients having a repeat angiography at 8 months (± 1 month).

It is anticipated the total duration of the study will be 18 months: 6 months to complete patient enrollment and 12 months for follow up.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of angina pectoris as defined by Canadian Cardiovascular Society Classification (CCS I, II, III, IV) OR unstable angina pectoris (Braunwald Classification B I-II) OR patients with documented silent ischemia;
* Manifest diabetes mellitus, proven by fasting glucose (12 h) \> 127 mg/dl or oral glucose challenge: \>= 200 mg/dl after 2 h or diabetes mellitus already treated with oral antidiabetics or insulin;
* Treatment of a de novo native coronary artery lesion in a major coronary artery in patients with single or multi-vessel disease; patients with 2- or more-vessel-disease can be enrolled if previous treatment(s) of those lesions other than the target lesion have taken place at least 3 months prior to the enrolment to this study. If more than 1 study stent is necessary to treat the lesion, overlapping is strongly recommended;
* Target vessel diameter at the lesion site is \>= 2.5mm and \<= 3.5mm (visual estimate); (stents will be available in 2.5 / 3.0 mm width);
* Target lesion is \<= 42mm in length (visual estimate); (stents will be available in 8, 18 and 33 mm length);
* Target lesion diameter stenosis is \> 50% and \<100% (visual estimate);

Exclusion Criteria:

None
High Flow Nasal Cannula in Preterm Infants

The HIFLO study evaluates the impact of HFNC oxygen therapy on duration of nCPAP therapy, oxygen therapy and hospitalization. The cost of use of CPAP and two HFNC devices are also evaluated.

Nasal continuous positive airway pressure (nCPAP) is widely used in preterm infants as it is efficient, but it creates an unfavorable environment for preterm infants. Indeed is a primary source of continuous noise in neonatal units and causes discomfort, pain, skin lesions. High flow nasal cannula (HFNC) introduced more recently in neonatal care supplies high allowing for carbon dioxide nasopharyngeal wash-out, reduction of work of breathing and is well tolerated. HFNC could help to improve the environment of preterm infants by reducing deleterious stimuli (noise, pain, discomfort) and by facilitating the contact between parents and babies. Efficacy of HFNC seems to be similar to other non-invasive respiratory supports for preventing treatment failure, death and bronchopulmonary dysplasia. The benefits of HFNC implementation was only slightly analyzed in extremely preterm infants. the place of HFNC is becoming increasingly important in neonatology and could help to improve the quality of care. Few HFNC devices are available but their cost of use has not been evaluated in Europe.

HIFLO study aimed to assess the impact of HFNC therapy introduction, on exposure to nCPAP and on the duration of oxygen therapy and hospital stay in preterm infants and in a subgroup of extremely preterm infants. The investigators also aim to evaluate the cost of use of nCPAP and HFNC using two different devices.

Eligibility Criteria:
Inclusion Criteria:

* Infants born before 32 weeks of gestational age
* Birth weight below 1500 g
* Infants hospitalized within the first 48 hours of life
* Infants discharged home from our unit

Exclusion Criteria:

* Infants transferred to another unit
* Infants with a severe malformation
* Infants requiring surgery
Prophylactic Effect of Memantine in Chronic Tension-Type Headache

The purpose of this study is to test whether memantine has a prophylactic effect on chronic tension-type headaches.


Eligibility Criteria:
Inclusion Criteria:

* Chronic tension-type headache
* Normal urine pH

Exclusion Criteria:

* More than 1 migraine attack/month
* Other major illnesses
* Overuse of medicine/alcohol
* Women not using AC
* Pregnant/breast-feeding women
* Allergy to memantine