cyrilzakka/clinical-trials huggingface dataset:
Non-insulino-dependant Diabetes in Infants and Teenagers

The incidence of diabetes in children, which is constantly increasing worldwide is estimated in mainland France at about 15/100 000 per year with a wide disparity between countries and a north gradient South.

In Reunion island, about 30 children a year seem to reveal diabetes before the age of 18 years but no precise data has ever been published on this subject.

Indeed, while type 1 diabetes (insulin-dependent autoimmune) represents historically the majority of cases of diabetes revealed at pediatric age (about 90%), since a little more than 10 years other types of diabetes seem emerge at pediatric age. This is particularly the case of type 2 diabetes in connection with the global epidemic of obesity.

The purpose of the investigator's study is the exhaustive prospective collection of all cases of diabetes revealed before the age of 18 in the Reunion region over a period of 5 years.


Eligibility Criteria:
Inclusion Criteria:

* child or adolescent residing in the territory of the reunion island
* with a diagnosis that revealed diabetes according to criteria defined by WHO (World Health Organization) before 18 years of age
* Parents who signed the participation consent

Exclusion Criteria:

* Patient not residing in the usual way in Reunion island
Imaging of the Esophagus Using a SECM Capsule

The goal of this validation study is to compare Spectrally Encoded Confocal Microscopy (SECM) Tethered Capsule Endoscopy (TCE) diagnosis of Eosinophilic Esophagitis to that of standard of care endoscopic biopsy.

Eosinophilic esophagitis is an inflammatory condition of the esophagus that occurs in response to certain foods or allergens. Approximately 300,000 people in the US have EoE, the incidence of newly diagnosed EoE is \~30,000/year, and EoE is found in 5-10% of all patients undergoing upper endoscopy. EoE is associated with debilitating symptoms, and is a common cause of dysphagia, strictures, and food impaction; it may even lead to esophageal perforation. Because of the impact of EoE on quality of life as well as the concern that this disease may progress to esophageal fibrosis with unknown long-term risks, experts recommend that EoE be treated until symptoms and eosinophilic infiltrate are resolved. Because the only objective method for diagnosing EoE is histopathologic assessment of multiple upper endoscopic biopsies, the processes of monitoring the esophagus during therapy and the food reintroduction involve a high number of repeat endoscopies. This process is both time consuming and frustrating for patients and their families. Because the endoscopic biopsy requires conscious sedation, it is also costly, exceeding $1000 per procedure. Given the rapid increase in the number of patients with this disease, there is a compelling need for a less invasive and more cost-effective means of identifying eosinophils in the esophagus.

Based on the extensive experience with Optical Coherence Tomography (OCT) and OFDI, the investigators at Tearney laboratory at MGH have developed a spectrally encoded confocal microscopy (SECM) technology that is able to acquire images at significantly higher frame rates than standard confocal microscopy. This SECM capability enables imaging of large portions of the esophagus at 2-µm resolution in realistic procedure times. Furthermore, the investigators at Tearney laboratory have created a tethered capsule SECM device that can be swallowed and used for EoE screening. The investigators at Tearney laboratory lab performed a pilot study using a SECM capsule on 58 subjects (2013-P-000863). The imaging was successful with no adverse or unanticipated events. SECM endoscopy capsule is similar to the approved endoscopy capsule.

A total of sixty (60) subjects will be recruited for this study. The imaging of the esophagus will be obtained. Subjects will not be sedated for the procedure.

The images obtained by the SECM capsule will be compared to the images obtained by the clinical endoscopy and biopsy. SECM imaging will be used for research purposes only and will not be used for diagnosis purposes.

Eligibility Criteria:
Inclusion Criteria:

* 12 years of age or older undergoing endoscopic biopsy for evaluation of EoE
* Able to give informed consent

Exclusion Criteria:

* Inability to swallow pills and capsules
* Esophageal fistula and/or esophageal strictures with a stricture diameter that is smaller than the diameter of the capsule
Impact of Mandibular Overdenture Base Construction Techniques on Assessment of Occlusion

This within patient study will be conducted to compare between two different construction techniques (CAD-CAM Milled and Conventional techniques) of 4-implant-assisted complete mandibular overdenture bases regarding the digital occlusion force balance analysis using the OccluSense


Eligibility Criteria:
Inclusion Criteria:

* 1. Free from any systemic diseases that contraindicate dental implantation. 2. Angel's class I maxillo- mandibular relation. 3. Available inter-arch space and sufficient restorative space. 4. Nonsmokers, non-alcoholics. 5. Complaints from their conventional denture

Exclusion Criteria:

* diabetic and heavy smoker patients
Efficacy and Acceptability of Low-Residue Diet Package (Enimaclin®) as Diet Control Before Colonoscopy

The purpose of this study is to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.

In this study, we investigate a randomized, single-blinded, comparative study to evaluate the efficacy and the acceptability of low-residue diet package (Enimaclin®) as diet control before colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* Outpatient or healthy volunteer for health examination, 20\~75 years old
* Eligible for oral bowel preparation
* BMI (Body Mass Index) ≤ 30

Exclusion Criteria:

* Patients with severe constipation (as fewer than three stools per week)
* Patients with bowel obstruction
* Patients contraindicated with treatment drug
* Patients who need emergency medication
* Ineligible for bowel preparation
* Pregnant or breast-feeding
* Patients with known allergies to treatment drug or low-residue diet package
* Patients who are ineligible to enroll
D4 Choline Breast PET/CT

The aim of this study is to evaluate the effect of CDK4/6 inhibitor treatment on the tumour choline metabolism as determined by \[18F\]D4-FCH PET/ computed tomography(CT) in breast cancer and to determine the suitability of \[18F\]D4-FCH-PET/CT as a non-invasive, early imaging biomarker for therapy response following CDK4/6 inhibitor treatment.

A target of 16 evaluable participants will be recruited to this study. Participants will have\[18F\]D4-FCH PET/CT imaging on each of 2 visits Scan 1: Baseline scan to be conducted prior to initiating standard of care CDK4/6 inhibitor-based therapy drug therapy.

Scan2: Early post-treatment scan to be conducted at 4-6 weeks after initiating therapy.

Each participant will provide written consent to take part in the study before they undergo screening assessments to confirm eligibility. On the day of imaging the participants will have a blood sample taken for circulating tumour DNA prior to the scan.

A single dose of \[18F\]D4-FCH IV will be administered to the participant followed by dynamic/ whole body imaging.

Optional tumour biopsies at baseline and after 4-6 weeks of CDK4/6 inhibitor treatment will be obtained, or if there is a suitable archival pre-treatment biopsy that has been taken within 18 months, this can be retrieved for baseline analysis.

Clinical data for progression/ survival followed up for up to 24 months.

Eligibility Criteria:
Inclusion Criteria:

1. Female patients with a histological diagnosis of locally advanced or metastatic estrogen-receptor positive, HER2 negative breast cancer
2. Written informed consent prior to admission in the study.
3. Target lesion diameter of ≥15mm that has not been previously irradiated and is located outside the liver
4. Female patients aged ≥ 18 years of age
5. For all patients: histologically confirmed locally advanced/ metastatic breast cancer with a previous biopsy confirming hormone receptor and HER2 status
6. ECOG performance status 0-2
7. Negative urine pregnancy test (within 2 hours prior to injection of imaging agent) in women of child bearing age and willingness to use contraception (barrier, abstinence, non-hormonal) for 3 weeks after injection of \[18F\]D4-FCH
8. Life expectancy \> 3months
9. Adequate organ function as judged by investigator to include:

   * Hb≥ 10g/L
   * Creatinine clearance ≥45ml/min
10. Patients must have been appropriately staged (which may include contrast enhanced CT/ FDG-PET/ MRI) within 42 days of study entry and additional imaging according to local standard of care

Exclusion Criteria:

1. Pregnant or lactating women
2. Evidence of significant medical condition or laboratory finding which, in the opinion of the Investigator, makes it undesirable for the patient to participate in the trial
3. Participants with severe claustrophobia or who are unable to lie flat or fit into the scanner (≥350 lbs (160 Kg))
4. Prior use within 14 days of enrolment or concurrent therapy with any other investigational agent
5. Patients classified as radiation workers
6. Patient has previously received treatment with CDK 4/6 inhibitors
Evaluation of the Tolerability and Efficacy of CWT-f-002 Lubricant Eye Drops

The primary objective is to evaluate the tolerability and efficacy of CWT-f-002 lubricant eye drops in the treatment of the signs and symptoms of dry eye disease.

In this study CWT-f-002 lubricant eye drop is being evaluated in subjects with dry eye. This OTC eye drop has previously shown promising results in multiple preclinical and clinical settings. The active comparator for this study is Systane (R). Ingredient lists as follows. CWT-f-002: Active Ingredients are glycerin 0.7% and polyethylene glycol 400 0.4%. Inactive ingredients are mannitol, polylysine-graft-polyethylene glycol, sterile water for injection, and sodium phosphate buffer. Systane: Active ingredients are polyethylene glycol 400 0.4% and propylene glycol 0.3%. Inactive ingredients are boric acid, calcium chloride, hydroxypropyl guar, magnesium chloride, potassium chloride, purified water, sodium chloride, zinc chloride. Systane (R) may contain hydrochloric acid and/or sodium hydroxide to adjust pH. Both products are preservative free and supplied in unit dosers.

Eligibility Criteria:
Inclusion Criteria:

* Be at least 18 years of age
* Have a reported history of dry eye for at least 6 months
* Have a Tear Film Breakup Time (TFBUT) measurement of \>1 and \<7 seconds at Visit 1

Exclusion Criteria:

* Known contraindications or sensitivities to the use of the study treatment or any of its components
* Have a clinically significant slit lamp finding at Visit 1 that may include active blepharitis, meibomian gland dysfunction (MGD), lid margin inflammation, or active ocular allergies that require therapeutic treatment, and/or in the opinion of the investigator may interfere with study parameters
* Have a condition (ocular or systemic) that the investigator feels may put the subject at significant risk, may confound the study results, or may interfere significantly with the subject's participation in the trial
Smoking Cessation in Menthol Flavored Cigarette Smokers

The purpose of this study is to determine if in smokers of menthol cigarettes, switching to non-menthol cigarettes prior to a cessation attempt results in greater cessation success than attempting to quit without first switching


Eligibility Criteria:
Inclusion Criteria:

* Self identify as African American
* smoke primarily menthol cigarettes
* be between the ages of 18 and 64
* smoke a minimum number of cigarettes per day
* express an interest in quitting smoking

Exclusion Criteria:

* current unstable medical / psychiatric condition
* regular use any form of nicotine or tobacco other than cigarettes
* are pregnant or breast feeding

The investigators will evaluate if there are other reasons why someone may not be eligible to participate
Optimizing Treatment on Idiopathic Inflammatory Myopathies

As a T2T, our patients with idiopathic inflammatory myopathies will receive pulse therapies with methyprednisolone and/or human intravenous immunoglobulin, or only methyprednisolone at disease onset.

This scheme is an internal routine protocol of our Service.

To compare two groups of patients as described in Brief Summary.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic inflammatory myopathies

Exclusion Criteria:

* Inclusion body myositis, muscular dystrophies, neoplasia-associated myopathies, overlapped myopathies, others myopathies
Preoperative Bath in Patients Submitted to Hip Arthroplasty

Clinical trial for prevention, randomized, controlled, blinded, parallel, with three arms which purpose is verify the effects of nursing intervention preoperative bathing with 4% chlorhexidine gluconate, 10% Povidone iodine (PVPI) and soap without antiseptic, for the prevention of surgical site infection (SSI) in patients undergoing hip arthroplasty.

Despite the recommendation in several guidelines of preoperative bathing with 4% chlorhexidine gluconate as a measure for the prevention of SSI, there is no evidence in the literature that support this practice. The objective of this study is to evaluate the effect of nursing intervention: preoperative bath using 4% chlorhexidine gluconate solutions, 10% povidone iodine degermante or soap without antiseptic for the prevention of SSI in patients undergoing elective hip arthroplasty surgery. The specific objectives are to compare the incidence of SSI in the three interventions, to assess the most effective intervention for the prevention of surgical infection and to estimate the frequency of allergic reactions caused by the use of the solutions. Two intervention groups (4% Chlorhexidine gluconate and PVPI10%) and a control group (without antiseptic soap) composed of 52 patients undergoing hip arthroplasty in each group will be randomized to perform the baths in the period from may 2015 to june 2017. Before the intervention, nasal swabs will be collected of patients to investigate colonization by Staphylococcus aureus.

The expected result is lower ISC rate with the proposed measures.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 or older;
* Elective procedure of total hip arthroplasty
* No report of infectious focus at the surgical site
* Know to respond to the clinical signs of a surgical infection or having a person responsible with this ability
* Do not be a nasal carrier of Staphylococcus aureus before surgery
* Have access to fixed or mobile phone

Exclusion Criteria:

* Patient treating surgical site infection
* Emergency hip prosthesis surgery or orthopedic trauma
* Nasal carriers of Staphylococcus aureus before surgery
* Previous history of allergic reactions to the products used in the bat
Long Term Safety Study of (VIT45) Extension Study: Treatment of Anemia in Non-Dialysis Dependent Chronic Kidney Disease

The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004 (NCT00317239).

The primary objective of this study is to evaluate the long term safety and tolerability of an iron maintenance dosing strategy utilizing VIT45 in the treatment of anemia of non-dialysis dependent chronic kidney disease (NDD-CKD). This study is a long term extension to protocol 1VIT04004.

In this study patients that complete protocol 1VIT 04004 or are discontinued will be offered to participate in this extension study.

Eligibility Criteria:
Inclusion Criteria:

* Subjects who completed or discontinued Protocol 1VIT04004

Exclusion Criteria:

* Known hypersensitivity reaction to VIT-45
* Anemia not related to CKD
* Chronic, serious infection
* Recent IV iron other than study drug in past 12 weeks
* Recent blood loss within the last 12 weeks
* Need for surgery or dialysis
* Female subjects who are pregnant or lactating
Pleural Manometry in Thoracocentesis

The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.

This prospective controlled trial study will be performed between July 2019 and December 2020. the investigators will enroll patients with large volume pleural effusion referred to our Cardiothoracic Department, Faculty of Medicine, Ain Shams University to perform therapeutic thoracentesis. All the patients will sign an informed consent for pleural pressure monitoring during and after therapeutic thoracentesis.

The study aiming to measure the pleural pressure during thoracocentesis in patients with pleural effusion and the value of their measurement in both diagnostic and therapeutic decisions.

Eligibility Criteria:
Inclusion Criteria:

1. age between 18 and 85 years,
2. pleural effusion occupying at least one-third of the ipsilateral hemithorax in P-A chest radiograph (CXR)
3. no contraindications for therapeutic thoracentesis
4. general health condition allowing prolonged procedure of therapeutic thoracentesis.

Exclusion Criteria:

* patients with very small amounts of pleural effusion
* patients on mechanical ventilation
* patients using anticoagulant therapy
* patients refusing to be subjected to thoracocentesis.
Vaccine Immunity and Inflammation in the Aging Person Living With HIV

This study will track immune responsiveness to conjugate pneumococcal vaccines over time to help determine how long protection from this vaccine lasts in individuals with chronic medical conditions (in this study - HIV) and with age.

Persons living with HIV (PLWH) are at increased risk of chronic inflammation and the associated adverse health outcomes. There is considerable evidence that chronic inflammatory conditions like metabolic disease and autoimmune disorders as associated with weakened vaccine responses and existing vaccine studies in PLWH do not adequately sample older individuals who are disproportionately affected by this "inflammaging." We hypothesize the effect of age on poor vaccine responses is greater among PLWH given the additional burdens of HIV driven inflammation. The overall project goal is to examine this premise by measuring the impact of HIV status, age, and chronic immune activation on conjugate pneumococcal vaccine responses. We will study acute (30 day) and longer-term (2 year) immune responses following PCV vaccination, among a cohort of participants including 4 groups: a) older PLWH, age ≥50 (n=100), b) older HIV uninfected controls, age ≥50 (n=50), c) younger PLWH, age \<50 (n=50), d) younger HIV uninfected controls, age \<50 (n=50). With these cohorts, we will 1) Comprehensively characterize the impact of HIV and age on the immunogenicity of conjugate pneumococcal vaccination by longitudinally tracking adaptive vaccine-specific antibody, B cell and cluster of differentiation 4 T cell responses. We will compare these responses by age and HIV status. We will also 2) Determine the influence of chronic inflammation on vaccine-specific immunity among PLWH across the adult lifespan by measuring the associate between vaccine immunity and biomarkers of chronic inflammation. This project will provide valuable knowledge on how HIV and age influence vaccine immune responses with the hope of informing vaccine development and schedule to optimize the long-term health of persons living with HIV.

Eligibility Criteria:
Inclusion Criteria:

* Age\>=18 years
* HIV Diagnosis
* On Antiretroviral Therapy with HIV Viral Load\<200 within last year

Exclusion Criteria:

* Other significant immunosuppressing condition
* Age\< 18 years
* Pregnancy (at enrollment)
* Contraindication to pneumococcal vaccination
* Known contraindication to non-clinical blood draws (severe anemia last hemoglobin \<8g/dl)
* Subjects who, in the opinion of the Investigator, may be non-adherent to study schedules or procedures.
* Adults unable to consent
* Individuals with impaired ability to consent
* Incarceration at time of enrollment

Controls inclusion criteria:

* Age\>=18 years
* HIV Ag-Ab test negative
Part Two of Novel Adoptive Cellular Therapy With SARS-CoV-2 Specific T Cells in Patients With Severe COVID-19

The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections.

A novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is the cause of Coronavirus Disease 2019 (COVID-19). Currently, no vaccine has been proven to be effective. While waiting for vaccine to be developed, passive immunity can be acquired immediately by adoptive transfer of SARS-CoV-2 specific T cells from convalescent donors into newly infected patients.

The overall objective of this project is to develop an emergent treatment protocol using adoptive T-cell therapy for the treatment of severe COVID-19. The central hypothesis is that SARS-CoV-2 specific T cells from convalescent donors who have recovered from COVID-19 can be manufactured expeditiously and these cells are safe and effective for the treatment of severe SARS-CoV-2 infections. Part Two of this project is to assess the safety and efficacy of these T cells in patients with COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Age 1 to 90 years
* Tested positive for SARS-CoV-2 \<72 hours prior to enrolment
* Predicted to have high chance of mortality:

Group 1: Severe disease, defined by one or more of the following:

* Dyspnea
* Respiratory frequency ≥ 30/min
* Blood oxygen saturation ≤ 93%
* Partial pressure of arterial oxygen to fraction of inspired oxygen ratio \< 300
* Lung infiltrates \> 50% within 24 to 48 hours
* Respiratory failure
* Septic shock
* Multiple organ dysfunction or failure

Group 2: Mild to moderate disease, at high risk of progression to severe disease. For example,

* Age \> 65 years
* Chronic health conditions such as chronic lung disease, cardiovascular disease, diabetes mellitus, obesity, end-stage renal disease or liver disease

Exclusion Criteria:

* Rapidly progressive disease with anticipated life-expectancy \<72 hours
* Receiving steroid (\>0.5mg/kg methylprednisolone equivalent)
* Pregnancy
* Breastfeeding
Internet-administrated Treatment of Anxiety Symptoms for Young Adults

The purpose of this study is to determine whether tailored internet-administrated CBT is a feasible approach in the treatment of anxiety symptoms and comorbid anxiety and depressive symptoms in a clinical setting.


Eligibility Criteria:
Inclusion Criteria:

* Be between the ages of 16-25 years old
* Have anxiety symptoms and/or anxiety syndrome

Exclusion Criteria:

* Suicide prone
* Alcohol addiction
* Ongoing psychological treatment