cyrilzakka/clinical-trials huggingface dataset:
White Matter in Pediatric Bipolar Disorder: A DTI Study

Fourteen subjects with bipolar disorder and 14 matching healthy controls, aged 6-13, will receive a magnetic resonance imaging (MRI) scan on a 3 Tesla scanner. They will also have a clinical interview, including the KSADS-PL. All subjects must be right-handed.

We propose to investigate the connectivity of white matter tracts using diffusion tensor imaging (DTI) in children with very early onset bipolar disorder (BPD). We hypothesize that the connectivity between the prefrontal cortex and the temporal lobe and parietal lobe and limbic structures will be abnormal, indicating white matter and gray matter deficits in early onset BPD. We also hypothesize that the superior lateral fasciculus cingulum bundle and the inferior lateral fasciculus will have decreased fractional anisotropy in very early onset BPD relative to healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Age 6 to 13
* Male or female
* Right-handed

Exclusion Criteria:

* IQ less than 70
* Learning disabilities
* History of autism, schizophrenia, anorexia or bulimia nervosa
* Substance abuse
* Claustrophobia
* Metal in body
* Pregnancy or lactation
Oxygen Toxicity in the Resuscitation in Extremely Premature Infants

The investigators hypothesize that using low oxygen concentrations during resuscitation of extremely premature infants will avoid oxidative stress derived damage and improve outcome.

This is a prospective randomized trial enrolling premature infants of less than 28 weeks gestation. Patients are randomly assigned to become resuscitation with an initial oxygen inspiratory fraction (FiO2) of 30% or 90%. Main objective is to reach a target saturation of 85% at 15 min of life.

Immediately after birth pre-and-postductal pulse oximeters are set and oxygen saturation (SpO2) continuously monitored and registered as long as the patient requires oxygen supplementation. FiO2 is stepwise adjusted (increased or decreased 10%) every 90 sec according to heart rate, SpO2 and responsiveness.

Blood samples are drawn from umbilical cord and at day 1, 2 and 7 from peripheral vein to determine oxidative stress markers (GSH, GSSG), angiogenic factors (VEGF, VEGF receptors, Angiopoietin), pro-inflammatory markers (IL8, TNF alfa) and pro-apoptotic markers (Fas Ligand; Cytochrome C).

Urine is collected every day during the first week of life to determine oxidative stress markers (8-oxo-dG; O-tyrosine; F2 isoprostanes; Isofurans).

Babies are followed in the NICU and clinical condition recorded. Serial examinations for ROP and Auditory evoked potentials will be performed. Neurodevelopmental outcome is evaluated at 2 years of postnatal life. Main outcome: Achievement of a target saturation of 85% at 15 min of life. Secondary outcomes: acute complications during delivery; chronic complications (BPD, ROP, IPVH); mortality in the neonatal period.

Eligibility Criteria:
Inclusion Criteria:

* Prematurity of less than 28 weeks gestation

Exclusion Criteria:

* Severe malformations
* Chromosomopathies
* Informed consent not signed
An Exploratory Clinical Investigation Evaluating Two Abutment Surfaces

A total of 22 subjects will be included in the study. The subjects who were treated with NobelActive TiUnite and On1 machined abutment will be enrolled in the control group and subjects who were treated with NobelActive TiUltra and On1 Base Xeal abutments will be enrolled in the test group. Two peri-implant crevicular fluid (PICF) samples will be collected for immunological testing and two plaques samples will be collected for microbiological testing from all the enrolled subjects one from the control/test implant site and one from the contralateral tooth/implant site. 3 weeks after the first sampling PICF and plaques sampling will be repeated the same way.

The main objective of the study is to evaluate the clinical, microbiological, and immunological biomarkers of implant sites which were treated with two different implant-abutment-systems (anodized surface and machined surface). This single-center exploratory study includes 22 subjects, divided into two distinct groups: Test group and Control group. All subjects in both groups have undergone treatment. In the Test group, subjects were treated between 2019 and 2020 with the NobelActive TiUltra implant and On1 Base Xeal abutment, while in the Control group, treatment occurred in 2017 with NobelActive TiUnite implant and On1 machined abutment. All subjects were treated by the same clinician, Dr Giacomo Fabbri, and were participants in two approved clinical study protocols (T-190 and IIT 2017-1538) approaved by local Ethics Committee. T-190, a multicenter study, involved 21 subjects from Dr Fabbri's center, with 12 subjects available for recall (Control group) in this study. The IIT 2017-1538 study included 61 subjects, with 12 subjects scheduled for recall (Test group) in the current study. Two subjects were part of both the studies, received both the implant abutment solutions and belong to both the groups. The subjects are enrolled provided they meet all the inclusion and none of the exclusion criteria and sign the informed consent. Peri-implant crevicular fluid (PICF) and plaques samples will be collected from control and test implant sites (and respective contralateral tooth/implants) of each participating subject for immunological and microbiological testing at two time points with an interval of approximately 3 weeks between the two sample collections.

Eligibility Criteria:
Inclusion Criteria:

* Subjects willing to sign the Informed Consent Form
* Subjects able to adhere to the investigation schedule
* Subjects with no previous surgical intervention or soft tissue complications in the area of the implant site (e.g., localized mucositis, mild peri-implantitis, etc.) within 3 months before first sample collection
* Subjects regularly adhere to a professional oral hygiene maintenance program
* No recent antibiotics or biological therapy (or any treatment that activates or suppresses the immune system)
* No xerostomia

Exclusion Criteria:

* Subject not willing to sign the Informed Consent Form
* Subject not able to adhere to the investigation schedule
Artificial Intelligence-assisted Confocal Laser Endomicroscopy Identification of Intestinal Metaplasia Severity

Currently, the Correa cascade is a widely accepted model of gastric carcinogenesis. Intestinal metaplasia is a high risk factor for gastric cancer. According to Sydney criteria, mild intestinal metaplasia was not associated with gastric cancer, while moderate to severe intestinal metaplasia was strongly associated with the development of gastric cancer. Because intestinal metaplasia is distributed in various forms, the use of white light endoscopy lacks specificity, and the consistency with histopathological diagnosis is poor; Pathological biopsy is still needed to make a diagnosis. At present, national guidelines suggest that OLGIM score should be used to evaluate the risk of gastric cancer, and patients with OLGIM grade III/IV should be monitored by close gastroscopy. However, it requires at least four biopsies, which is clinically infeasible. Confocal laser endomicroscopy allows real-time observation of living tissue, comparable to pathological findings.

Gastric cancer is a common malignant tumor in digestive system diseases. Currently, the Correa cascade is a widely accepted model of gastric carcinogenesis. Intestinal metaplasia is a high risk factor for gastric cancer and is considered a precancerous condition of intestinal type gastric cancer. According to Sydney criteria, mild intestinal metaplasia was not associated with gastric cancer, while moderate to severe intestinal metaplasia was strongly associated with the development of gastric cancer. Because intestinal metaplasia is distributed in various forms, the use of white light endoscopy lacks specificity, and the consistency with histopathological diagnosis is poor; Pathological biopsy is still needed to make a diagnosis. At present, our national guidelines suggest that OLGIM score should be used to evaluate the risk of gastric cancer, and patients with OLGIM grade III/IV should be monitored by close gastroscopy. However, it requires at least four biopsies, which is clinically infeasible. Confocal laser endomicroscopy allows real-time observation of living tissue, comparable to pathological findings. Therefore, we established artificial intelligence-assisted confocal laser endoscope technology to determine the high risk of gastric cancer in real time, instead of tissue biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 18-80 years undergoing confocal gastroscopy

Exclusion Criteria:

* Patients with severe cardiac, cerebral, pulmonary or renal dysfunction or psychiatric disorders who cannot participate in gastroscopy
* Patients with previous surgical procedures on the stomach
* Patients with contraindications to biopsy
* Patients who refuse to sign the informed consent form
The Effects of Vacuum-Compression Therapy on the Healing of Diabetic Foot Ulcers

the objective of this study is to evaluate the impact of vacuum-compression effects of Vasotrain on the diabetic foot ulcers using stereological method based on Cavalieri's principle in diabetic patients.

Diabetic foot ulcers are common and serious complications of chronic diabetes mellitus. The prevalence of foot ulcers among patients with diabetes is 15%. The length of hospital stay is approximately 60% longer among patients with foot ulcers, as compared with those without ulcers. Diabetic foot ulcers accounts for \>50% of all nontraumatic lower-leg amputations.Although, current preventive methods and treatment modalities have been effective in healing foot ulcers, statistics show high incidence of foot ulcers and amputations in individuals with diabetes.On the other hand, only a few studies were performed on the effects of Vasotrain in healing diabetic foot ulcers. The use of the machine enhances the delivery of oxygen and nutrients to the area, which in turn, facilitate wound healing

Eligibility Criteria:
Inclusion Criteria:

* A diabetic foot ulcer corresponding to grade 2
* No history of deep venous thrombosis and no hemorrhage in ulcer

Exclusion Criteria:

* Significant loss of protective sensation
* Hemorrhage during treatment
* Vertigo
* No completion of treatment
Controlling Hypertension in Diabetes- Feasibility Study

Many primary care patients, especially in inner-city settings, do not achieve targets for blood pressure and glycemic control. There is an urgent need to enhance treatment for those who do not reach goals within the usual clinical care system. We propose to develop a multi-component intervention grounded in the Chronic Care Model, and sustainable in resource-challenged settings. Through collaboration with home health nursing and with the use of home telemetry for feedback and intensification of therapy, we will augment usual clinical services to improve health outcomes for diabetes patients who have not been able to reach therapeutic goals. There are three specific aims. First, we will establish a feasible, practical and sustainable collaborative model between the primary care sites of our practice-based research network (NYC RING), clinical researchers at the Diabetes Research and Training Center, and The Montefiore Home Health Organization, integrating the unique expertise of each of the partners and defining the roles and responsibilities of each. Second, we will develop and refine the components of the intervention, to include training primary care providers and home health nurses to integrate the technical, psychosocial and communication processes for implementation of the intervention. Third, we will assess the feasibility of the collaborative intervention by implementing the intervention for 25 primary care patients and obtain preliminary estimates of effectiveness by comparing outcomes to 25 patients receiving usual care. Our proposal includes plans to develop feasible procedures for data collection, with qualitative and quantitative methods of assessing process and outcome measures. We will use these preliminary data to revise the intervention and prepare an R18 application to further develop and test the intervention in multiple inner-city primary care sites serving low-income diabetes patients. This proposal is for secondary prevention of diabetes complications, targeting a population known for health disparities and a high burden from this chronic disease.


Eligibility Criteria:
Inclusion Criteria:

* type 2 diabetes,
* BP above 140/90 on two health center visits,
* home touch tone phone

Exclusion Criteria:

* dementia,
* homelessness,
* language other than English or Spanish
Study of Safety, Efficacy, and Pharmacokinetics of Topical ACD440 in Healthy Volunteers

Phase 1 b placebo-controlled study in healthy volunteers to study safety, efficacy and pharmacokinetics of Topical ACD440 on normal skin, skin optimized for penetration and skin exposed to ultraviolet radiation

This is an exploratory study, no primary or secondary endpoints are being defined.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteer
* Fitzpatrick skin type II or III
* Women not childbearing potential or highly effective contraception

Exclusion Criteria:

* Pregnancy, lactation
* Drug abuse
* Clinically significant illness
* Positive COVID 19 test at screening or COVID 19 infection in the past
MarginProbe 2.0 Data Collection Protocol

Previous clinical studies with the MarginProbe (MP) system demonstrated the MP System diagnostic accuracy for identification of cancerous/abnormal tissue at the margins (≤ 1mm) of the ex-vivo lumpectomy specimen. The current study is a prospective data collection study with the enhanced technology, the MP2.0 System and is aimed at collecting data to optimize the system algorithm/procedure and to subsequently validate the system to demonstrate non-inferiority to the MP1.x system.

In this study, MP2.0 system will be used on ex-vivo lumpectomy specimens at the Operating Room (OR). The study will collect a library of case information data using the MP2.0 system in sequential cohorts of a minimum of 50 subjects until the software and procedure are optimized. The final analysis sample size will be determined and outlined in the SAP based upon the results of the optimization stage.


Eligibility Criteria:
Inclusion Criteria:

1. Women over 18 years of age
2. Diagnosed with cancer, undergoing lumpectomy or partial mastectomy procedure
3. Signed Informed Consent Form

Exclusion Criteria:

1. Undergoing re-excision procedure
2. Concurrent infectious disease
3. Pregnancy
4. Lactation
5. Previous surgery in the same site including open biopsy procedure, previous breast reduction or mastopexy in the operated breast
6. Prior radiation treatment in the operated breast
7. Participating in any other investigational study for either drug or device which can influence collection of valid data under this study
Proctologic Practice and Covid-19

Cross-sectional non-incentivized worldwide web survey.

A worldwide survey of 1050 respondents showed that proctologic practice has been seriously affected by the pandemic. Age, gender and level of hospital preparedness predicted the change of status of surgical and outpatient activities.

The results of our study may inform the development of strategies to reopen activities while protecting frontline healthcare workers.

A 27-item survey (namely, 'ProctoLock 2020') was designed and developed by the authors using an online platform ('Online surveys' \[formerly BOS - Bristol Online Survey\], developed by the University of Bristol) in accordance with the American Association for Public Opinion Research (AAPOR) guidelines and the Checklist for Reporting Results of Internet E-Surveys \[CHERRIES\]

Eligibility Criteria:
Inclusion Criteria:

Members of renowned scientific societies with an interest in coloproctology
Efficacy of Evonail® Solution in the Prevention of Nail Damage Induced by Docetaxel in Patients With Breast Cancer.

Docetaxel is widely used in oncology for the treatment of many solid tumors. The side effects of docetaxel are many and sometimes serious. The primary toxicity of docetaxel is neutropenia. Skin and nail manifestations, frequency, the second category of adverse events after haematological adverse events.

Use of the product Evonail® was demonstrated in a patient treated by doxetaxel and having nail damage.

The purpose of this study is to confirm the effectiveness of the film-forming solution Evonail® versus a placebo on the prevention of nail damage in women with breast cancer and treated by adjuvant docetaxel.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old
* Patient with breast carcinoma
* Patients treated with adjuvant chemotherapy (FEC + 3 docetaxel +/- Herceptin®)
* Patients who have never been treated with taxanes
* Patients with no nail damage before starting the study
* ECOG performance \< 2
* Ability to provide written informed consent

Exclusion Criteria:

* Patient allergic to any of the treatment components
* Use of film-forming solution, solvents or any other products applied to the fingernails (artificial nails ...) in three weeks before the first of docetaxel treatment
* Risk of exposure to aggressive factors nail during the study
* Using refrigerants gloves during chemotherapy treatments
* Onychophagia
* Presence of nail disease or a history of nail pathology (infectious and other)
* Pregnant or breast feeding females
* Patients whose condition is not compatible with the follow-up study
Clinical Evaluation of i-STAT Analyzer Glucose, Hematocrit and Sodium for Capillary Samples

The objective of this study is to compare the performance of two i-STAT Analyzers in a Point-of-Care (POC) setting. The evaluation will be performed using a cartridge to test glucose, hematocrit and sodium on capillary specimens.

The clinical performance for glucose, hematocrit and sodium assays for capillary samples was evaluated for the investigational i-STAT 500 (Alinity) analyzer based on results of method comparison testing against the i-STAT 1W analyzer.

Eligibility Criteria:
Inclusion Criteria:

* Subject is ≥ 18 years of age
* Subjects (or their legal representative) who are willing to voluntarily consent to the study

Exclusion Criteria:

* There are no exclusion criteria
A 6-Part Study In Healthy Volunteers To Evaluate Safety, Tolerability and Uptake Of MEDI7219 in the Body When Given as Single and Multiple Doses

This is a 6-part study to evaluate the safety, tolerability, and PK of MEDI7219 in healthy subjects. Parts A, B, C \& E are the single-dose parts of the study. Parts D \& F are the multiple ascending dose (MAD) parts of the study. The starting dose and formulation for Parts D \& F will be selected from data emerging from Parts A, B and E. Enrollment of approximately 198 subjects is anticipated.

MEDI7219 is being developed for the potential treatment of type 2 diabetes. The study is a first in human, single and multiple ascending dose study that will try to identify the safety, tolerability and pharmacokinetics (how the drug moves through the body) of MEDI7219. The study will also look at the impact of changes to the formulation as well as differences related to the route of administration. The study will consist of 6 parts involving approximately 198 healthy male and female subjects (and up to 146 additional subjects). In Part A, 6 cohorts of 10 subjects each (with an optional 2 cohorts) will be randomized to receive MEDI7219 or one of two placebos. Each cohort will receive a different formulation of the study drug. In part B, a single cohort of 16 subjects (with an optional second cohort) will receive a different formulation of MEDI7219 per period in up to 5 periods. In Part C, up to 12 subjects will be dosed with MEDI7219. In Part D, one cohort of 30 subjects (with an optional second cohort) will be randomized to receive MEDI7219 or placebo. Subjects will start on a dose based on data from previous parts and will receive ascending doses for 35 days. In Part E, 2 cohorts of 6 subjects each (with an optional third \& fourth cohort of 12 subjects each) will receive a different formulation of MEDI7219 per period. Part E, cohort 5 12 subjects each period (2 periods) has been added to assess 2 different formulations In Part F, two cohorts of 16 subjects each will be randomized to receive MEDI7219 or placebo. Subjects will start on a dose based on data from previous parts and will receive ascending doses for 35 days.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers age 18-55 years
* BMI 18-32 kg/m2
* Females not of childbearing potential
* Able and willing to adhere to the protocol
* Must provide written informed consent

Exclusion Criteria:

* Any concurrent condition that in the opinion of the investigator would interfere with the evaluation of the investigational product
* Abnormal lab values, physical exam, vital signs
* Positive drug or alcohol screen.
* Current enrollment in another clinical study or enrollment within the past 3 months
* Any clinically important illness, medical/surgical procedure, or trauma within 4 weeks prior to dosing
* Abnormal ECG
* Positive Hepatitis B, Hepatitis C or HIV test
* Positive Drug or Alcohol screen
* Current smokers or those who have smoked within the last 12 months
* Recent plasma or blood donation
* Evidence of current SARS-CoV-2 infection (Part E Cohort 5 and Part F Cohort 2 only)
Kawasaki Disease During the COVID-19 Epidemic

Northern Italy is the second region hit by the SARS-COV2 infection worldwide. Data on COVID-19 clinical presentation in children is still scarce, but fewer rate of infection and milder disease seem typical of this age group. In the last three weeks it has been reported an abnormal number of critically ill patients with clinical characteristics consistent with Kawasaki Shock Syndrome (KSS). The common manifestations are: "middle aged" children (6-9 y/o) with a history of persistent high spiking fever in the last days, abdominal pain, diarrhea, skin rash and rapidly deteriorating clinical condition with the onset of shock, without clear signs of dehydration. Other less common features are arthralgia, cough, meningism, conjunctivitis and reddened, cracked lips. Labworks usually show high inflammatory markers, low lymphocyte counts, low sodium, and high troponin levels. Echocardiography have been consistent with myocarditis in the majority of patient instead of classical coronary artery abnormalities. Patients have been diagnosed as Kawasaki disease (typical or incomplete) and treated accordingly with IntraVenous ImmunoGlobulin (IVIG) and/or steroids. One patient refractory to such treatments responded successfully to intravenous Anakinra. All the patients reported a family history consistent with COVID-19, serology and naso-pharyngeal swabs were inconsistently positive. To date we are aware of at least 10 such cases. KSS is a rare and dreadful complication, with an estimated prevalence of 5% of patients with Kawasaki Disease (KD). Given the extreme rarity of this condition, the occurrence of so many cases in the last weeks points to a possible causative agent. As our hospitals are in high endemic area, SARS-COV2 seems the most obvious, although testing for such infection in patients returned conflicting results. It is not clear, at this moment, if this clinical entity is a proper KD triggered by SARS-COV2, or a systemic vasculitis with similar features of KD, secondary to SARS-COV2 infection. The aim of this nationwide study is to better define this clinical entity.


Eligibility Criteria:
Inclusion Criteria:

* All children with clinical diagnosis of Kawasaki Disease
* age\<18 years
* Absence of other underlying chronic diseases

Exclusion Criteria:

* Presence of underlying chronic diseases
* Not fulfilling clinical criteria for Kawasaki Disease diagnosis