cyrilzakka/clinical-trials huggingface dataset:
Inflammatory Status of Visceral Adipose Tissue in Obese Patients Related to Periodontitis Severity

The research aims to compare the inflammatory status of visceral adipose tissue from obese patients depending on the presence and severity of periodontitis, in order to establish a potential causal link between the severity of the bacterial contamination and insulin resistance.

Recruitment of patients will be achieved in the department of digestive surgery. It will involve 122 patients with severe obesity undergoing bariatric surgery scheduled within the digestive surgery department. Patients recruited will be examined for evaluating the presence and severity of periodontitis, and separated into either group 1: for patients with moderate or severe periodontitis, and or group 2: for patients without or with mild periodontitis. The day before the surgery, blood sample will be collected for the analysis of circulating metabolic and inflammatory markers. Collection of stimulated saliva, periodontal sample and faeces samples (50 g) will also be carried out for bacteria determination. During the surgical procedure, a sample of visceral adipose tissue (50 g) will be collected and used for periodontal bacteria detection and inflammatory markers analyses.

Eligibility Criteria:
Inclusion Criteria:

* Patient eligible for bariatric surgery scheduled within the digestive surgery
* Patient affiliated to Social Security system or equivalent

Exclusion Criteria:

* Treatment with steroids or anti-inflammatory drugs in progress (or stopped for less than one month)
* Patients who received antibiotics within 3 months prior to the bariatric surgery for whatever duration
* Dental current (or older than 3 months)
* Participation in another research protocol
Ghrelin in Patients With a Rare Disease Associated With Intellectual Disability, and Hyperphagia, and/or Overweight, and/or Obesity

A significantly higher proportion of patients with rare diseases (RD) with intellectual disability (ID), present hyperphagia, overweight or obesity, compared to the general population. Prader-Willi syndrome is the only genetic obesity identified to date associated with hyperghrelinemia, while ghrelin levels are lower than in controls in other situations of obesity.

The aim of the study is to find out whether the levels of ghrelin, which are abnormally high in PWS throughout life, are also high in these RD when people have hyperphagia and/or overweight.

A significantly higher proportion of patients with rare diseases (RD) with intellectual disability (ID), present hyperphagia, overweight or obesity, compared to the general population. Prader-Willi Syndrome (PWS) and related syndromes (PWS-like) represent the most well-known causes of eating disorders with early and severe obesity. Other known RD with ID have been described as being associated with eating disorders with overweight or obesity, which appear later in adolescence : Angelman's syndrome (approximately 40% of patients are overweight or obese, and 32% of children have hyperphagia), Fragile X syndrome (over 30% are obese), Smith-Magenis syndrome (50 to 60% are obese). Prader-Willi syndrome is the only genetic obesity identified to date associated with hyperghrelinemia, while ghrelin levels are lower than in controls in other situations of obesity.

The aim of the study is to find out whether the levels of ghrelin, which are abnormally high in PWS throughout life, are also high in these pathologies when people have hyperphagia and/or overweight.

The study involves a single visit carried out during a routine follow-up in the CRMR, in which the blood sample will allow the dosage of the ghrelin hormon. The visit will also involves a data collection and some questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Patients with one of the following rare diseases associated with : Angelman syndrome, Smith-Magenis syndrome, X Fragile syndrome, rare diseases of the cerebellum, rare epilepsies, PW-like syndromes or other rare diseases with eating disorders
* Patients aged minimum 3 years and maximum 50 years.
* Patients with overweight (or obesity) and/or hyperphagic behavior.

Exclusion Criteria:

* Administrative problems: impossibility of giving parents or legal guardians informed information ; no coverage by a Social Security scheme.
A New Prognostic Stratification-based Safety and Efficacy Study of Ruxolitinib in Myelofibrosis

This is a multi-center, prospective, single-arm study to assess safety and efficacy of Ruxolitinib in myelofibrosis (MF) based on a new prognostic stratification.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female patients aged ≥18 years with a diagnosis of primary or secondary MF by World Health Organization and International Working Group for Myeloproliferative Neoplasms Research and Treat- ment (IWG-MRT) criteria;
2. Received ruxolitinib treatment for ≥3 months.

Exclusion Criteria:

1. Malignant tumors with other progression or myelofibrosis secondary to other diseases;
2. Exclude myelofibrosis patients after splenectomy;
3. Patients with poor compliance with case follow-up or lost to follow-up.
Induction Related BK Viremia in Renal Transplant Patients

The increase immunosuppression in our transplant population has led to an unacceptable rate of patients at risk for BK virus nephropathy. Reducing induction immunosuppression by switching from Thymoglobulin to Simulect will reduce the incidence of serum positivity for BK by PCR.

Our standard of care has been changed from Thymoglobulin to Simulect and now patients were enrolled in this observational trial to gather data on their outcomes related to BK viremia and rejection rates. Two groups of patients were compared.

Retrospective (historical or control) group of subjects: patients who had received a kidney transplant and were inducted with Thymoglobulin prior to study initiation.

Prospective group of subjects: patients who is scheduled to receive kidney transplant and will be inducted with Simulect (Basiliximab).

Inductions in both groups was/is Standard of Care at a time of treatment.

Eligibility Criteria:
Inclusion Criteria:

* De novo transplant
* Aged 18-75

Exclusion Criteria:

* Serious medical condition which, in the opinion of the Principal Investigator, might interfere with the subject's ability to successfully complete the protocol.
* Any medical condition which, in the opinion of the Principal Investigator, might compromise the safety of the subject in participating in the protocol
Telederm and Bullous Pemphigoid

The purpose of the study is to improve the quality of future clinical trials in bullous pemphigoid (BP), the investigators will monitor repeated measurement data from patients with BP on standard-of-care treatments at four week intervals for four months.

The study team plans to recruit 45 subjects from the autoimmune blistering disease clinic at Emory Dermatology Clinic. The plan is to improve the quality of future clinical trials in bullous pemphigoid (BP), the team will monitor repeated measurement data from patients with BP on standard-of-care treatments at four week intervals for four months. This time frame will allow completion of both aims in the three year time period. Aim 1 will evaluate the BPDAI scoring over time with specific reductions in the activity score as future outcomes for therapeutic response and assess changes in patient reported outcomes particularly related to pruritus for future clinical trial endpoints. Aim 2 will focus on the development of teledermatology platform for improving patient recruitment and retention. The data from this proposal will be critical for future BP clinical trials and clarify gaps in the current knowledge related to the natural disease history of BP patients on standard-of-care therapies, changes in BPDAI scores over time, and pruritus specific outcome measures to define the quality of life impact.

Eligibility Criteria:
Inclusion Criteria:

* Males or females \> age 18
* Clinical and histological confirmation of bullous pemphigoid including at least subepidermal separation on H\&E or a positive direct immunofluorescence along with indirect immunofluorescence which demonstrates staining to the roof on salt split skin or ELISA positivity for BP180 and/or BP230 autoantibodies
* Baseline BPDAI-TAS \>5

Exclusion Criteria:

* Subjects who are unable to consent, language barriers, or other unspecified reason that in the opinion of the investigator makes the subject unsuitable for enrollment. Subjects that do not meet all of the enrollment criteria may not be enrolled. Any violations of these criteria must be reported in accordance with IRB Policies and Procedures.
Combination of Ranibizumab and Verteporfin Therapy in Neovascular Age-related Macular Degeneration

The purpose of this study is to evaluate changes in preferential hyperacuity perimeter (PHP) and fundus autofluorescence (FAF) in patients with neovascular age-related macular degeneration receiving combination of ranibizumab (LucentisTM) and verteporfin (Visudyne®) therapy


Eligibility Criteria:
Inclusion Criteria:

* Signed written informed consent
* Age ≥ 50 years old
* Patients with primary active subfoveal CNV secondary to AMD
* Baseline best-corrected visual acuity (BCVA) in the study eye was from 20/40 to 20/400 using ETDRS chart
* Characteristics of AMD lesion

  * predominantly or minimally classic, or occult
  * absence of prior subfoveal treatment for macular disease
  * total lesion size ≤ 9 optic disc areas, with CNV component ≥ 50% of the lesion (unless a serous pigment epithelial detachment was present, in which case \< 50% CNV was acceptable)
  * active choroidal neovascularization leakage
  * submacular blood \< 50% and subretinal fibrosis \< 25% of the total lesion

Exclusion Criteria:

* additional eye disease that could compromise VA
* CNV unrelated to AMD
* ocular inflammation
* vitreous hemorrhage
* retinal hemorrhage (other than AMD related submacular blood) \> 1 disc areas
* intraocular surgery ≤ 1 month before day 0
* uncontrolled glaucoma
* prior treatments with verteporfin PDT
* laser photocoagulation or other intervention for AMD
* previous treatment with external-beam radiation therapy or transpupillary thermotherapy
* history of vitrectomy
Validation and Reproducibility of S.P.A.T. With Allergens

To improve accuracy and take out human error opportunities, Hippo Dx developed S.P.A.T., an automated skin prick test. This study will provide a comparison between manual and automated skin prick test in allergic and non-allergic individuals with a panel of common inhalant allergens.

The primary endpoint is to compare the accuracy of S.P.A.T. to detect sensitization to common aeroallergens compared to a manual skin prick test (SPT).

It is a prospective monocentric study that will include 120 study participants.


Eligibility Criteria:
Inclusion Criteria:

Adults (18-65y) with presence or absence of self-reported symptoms of inhalant allergy will be included.

Exclusion Criteria:

* Skin pathology like chronic or exuberant urticaria, dermographism, chronic dermatitis that needs daily treatment
* Use of antihistaminic medication \< 7 days before the start of the study
* Use of tricyclic antidepressants (antihistamine activity) \< 7 days before the start of the study
* Use of topical corticoids on the forearm \< 7 days before the start of the study
* Use of Omalizumab \< 6 months before the start of the study
* Pregnancy: there is a remote possibility of inducing a systemic allergic reaction that could induce uterine contractions or necessitate the use of epinephrine (thought to cause constriction of the umbilical artery)
Risk Management in Primary Care

The proposed research is a prospective, non-comparative study based on a qualitative method, comprising a literature review followed by 2 successive series of Focus Groups with users and healthcare professionals of primary care in the French AURA region. The 2 Focus Group phases will make it possible to :

* propose an operational definition of the notion of a professional team in primary care (validation by consensus between the participants of the first 4 Focus Groups based on the definitions in the literature)
* describe the ways in which risks are managed in primary care teams (qualitative analysis of the contributions made by the participants in the next 12 Focus Groups organized in 12 primary care teams)


Eligibility Criteria:
Inclusion Criteria:

Healthcare professional

* Healthcare professional over 18 years of age, registered with the professional association on which he/she depends and holding an RPPS identification number with care activity as part of a coordinated practice, within a legally formalised care team working on a territorial health project, or care activity within a care team that is not legally formalized but defined as an entity bringing together ≥ 4 different professionals to care for the same patient.
* Most care provided on an outpatient basis
* Care activity in the AURA region
* Agreement to participate in the focus group Users
* Any user of the healthcare system over the age of 18
* Consulting a healthcare professional from a team included in the research
* Agreement to participate in the focus group

Exclusion Criteria:

Healthcare professional

* Primary care healthcare professional with a specific exclusive practice that does not form part of the overall management of a patient (e.g. homeopathy, mesotherapy, acupuncture, etc.) Users
* Persons deprived of their liberty by a judicial or administrative decision
* Adults under legal protection (guardianship, curatorship)
* Persons not affiliated to a social security scheme or beneficiaries of a similar scheme
Post- Approval Study on Patients Who Received a HeartWare HVAD® During IDE Trials

Patients will be approached to participate in this PAS after the HeartWare® Ventricular Assist System receives PMA approval for the indicated use as a bridge to cardiac transplantation.

Patients who participated in prior trials will be approached for this PAS as follows:

* Patients who are on continued HeartWare® System support, (original or exchange device)
* Patients who have been explanted for transplant or recovery and have not yet completed 6 months of follow-up

Patients who participated in prior trials who will not be approached to participate in this follow-up study include:

• Patients who have been explanted for transplant or recovery and have completed at least 6 months of follow-up (documented in the prior IDE trial).

No new patients are being screened or implanted with the HeartWare® System for this trial, it is a follow-up trial only.

Eligibility Criteria:
Inclusion Criteria:

1. The patient has participated in a prior HeartWare trial under IDE G070199.
2. The patient was implanted with the HeartWare® Ventricular Assist System and was an active patient in the prior trial.
3. The patient has signed informed consent for participation in the study.

Exclusion Criteria:

1. The patient is unwilling or unable to comply with trial requirements.
2. The patient did not sign the informed consent.
Evaluation of Postoperative Acute Kidney Injury (AKI) Incidence and Risk Factors in Patients Underwent Pneumonectomy

Acute kidney injury (AKI) is a critical complication associated with a high incidence of morbidity and mortality that can occur in critically ill patients and after major surgical procedures. The aim of this study is to identify the incidance and outcomes of patients underwent pneumonectomy, defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria.

Acute kidney injury (AKI) is a critical complication associated with a high incidence of morbidity and mortality that can occur in critically ill patients and after major surgical procedures. Although there is a decrease in pulmonary damage with restrictive fluid management and protective ventilatory strategies in patients who underwent wide lung resection to prevent pulmonary edema development after resection, the relative hypovolemia and hypoperfusion developed in patients may lead to renal dysfunction. The incidence of AKI after thoracic surgery can be up to 15% and is associated with prolonged length of stay (LOS) in hospital. The incidence of AKI is higher in patients with extensive resection such as pneumonectomy compared with lobectomy and wedge resection. Since AKI is not only a rare complication but also a risk factor for mortality, it is important to identify the incidence and risk factors of AKI, to prevent AKI and related complications and to improve patients outcomes. In this study incidence of AKI was defined using the KDIGO criteria according to the change of serum creatine levels.

166 patients who underwent pneumonectomy from January 2008 to December 2018 included the retrospective observational study. Demographic data, intraoperative data, rates of complications, risk factors for AKI, mortality, lenght of stay in intensive care unit (İCU) and hospital were evaluated. AKI was defined using the KDIGO criteria according to the serum creatinine levels. The SPSS 11.5 program was used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patients underwent pneumonectomy, from January 2008 to December 2018

Exclusion Criteria:

* Chronic Kidney Disease
Gallium-68 PSMA-11 PET in Participants With Prostate Cancer

This phase II trial studies how well gallium-68 PSMA-11 PET/CT or PET/MRI works in finding prostate cancer cells that have come back (recurrent) in patients with prostate cancer. Gallium-68 PSMA-11 is a type of radioactive compound, called a radiotracer, which is injected in the vein and can accumulate in tumor cells to generate a signal detected by PET/CT or PET/MRI imaging. This may help researchers in finding recurrent prostate cancer cells in patients with prostate cancer.

PRIMARY OBJECTIVE:

I. To assess the positive predictive value (PPV) of gallium Ga 68-labeled PSMA-11 (68Ga-PSMA11) positron emission tomography/computed tomography (PET/CT) and positron emission tomography/magnetic resonance imaging (PET/MRI) on a patient level using histopathology or confirmatory imaging as a standard of truth (SoT).

SECONDARY OBJECTIVES:

I. To assess the PPV per-patient for 68Ga-PSMA-11 PET/CT and PET/MRI detection of tumor location confirmed by histopathology/biopsy alone.

II. Demonstrate the safety of 68Ga-PSMA-11 PET/CT or PET/MRI imaging in participants with prostate cancer.

III. Demonstrate the efficacy of 68Ga-PSMA-11 PET/CT or PET/MRI imaging to monitor response to treatment in participants with prostate cancer.

OUTLINE:

Patients receive gallium 68Ga-PSMA-11 intravenously (IV). 50-100 minutes after injection, patients then undergo a PET/CT scan or PET/MRI scan over 60 minutes.

After completion of study, patients are followed up at 30 and 90 days, then between 3-36 months.

Eligibility Criteria:
Inclusion Criteria:

* Pathologically proven prostate cancer
* Rising prostate-specific antigen (PSA) after definitive therapy with prostatectomy or radiation therapy (external beam or brachytherapy)
* Karnofsky performance status (KPS) \>= 50 (Eastern Cooperative Oncology Group \[ECOG\]/World Health Organization \[WHO\] 0, 1, or 2)
* Ability to understand and willingness to provide informed consent
* Participants with known metastatic prostate cancer planned to undergo active systemic treatment

Exclusion Criteria:

* Unable to lie flat, still, or tolerate a PET or MRI scan
* Contraindication to optional furosemide administration including prior allergy or adverse reaction to furosemide or sulfa drugs. This exclusion criteria can be removed if furosemide is omitted as part of the PET imaging protocol if a second-generation scatter correction - (defined as either Ga-68 specific prompt gamma correction or multiple scatter model) is available for the used PET device
A Study to Evaluate Risankizumab in Adults and Adolescents With Moderate to Severe Atopic Dermatitis

The purpose of this study is to assess the safety and efficacy of risankizumab for the treatment of moderate to severe atopic dermatitis (AD) in adults and adolescents.

This study includes a screening period of up to 35 days, a 16-week double-blind treatment period (Period A), and a 36-week double-blind treatment period (Period B).

Participants who meet eligibility criteria will be randomized at Baseline in a 2:2:1 ratio to one of 3 treatment groups: (1) risankizumab 150 mg, (2) risankizumab 300 mg, or (3) matching placebo. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis \[vIGA-AD\] score of moderate \[3\] versus severe \[4\]) and geographic region (Japan versus rest of world).

At Week 16, participants in the placebo group will be re-randomized in a 1:1 ratio to receive either risankizumab 150 mg or 300 mg for the remainder of the study. Participants originally randomized to the risankizumab 150 mg or 300 mg arms will stay on their previously-assigned treatment through the end of the study.

Eligibility Criteria:
Inclusion Criteria:

* adults who are ≥ 18 years old and, where locally permissible and approved, adolescent subjects who are at least 12 years old
* a diagnosis of atopic dermatitis (AD) with onset of symptoms at least 2 years prior to Baseline and subject meets Hanifin and Rajka criteria
* moderate to severe AD at the Baseline Visit
* history of inadequate response to previous topical corticosteroid and/or topical calcineurin inhibitor treatments or a medical inability to receive these treatments

Exclusion Criteria:

* prior exposure to any biologic immunomodulatory agent or Janus kinase (JAK) inhibitor
* concurrent treatment with systemic therapy for AD (biologic or non-biologic) or topical and/or phototherapy treatments
Universal vs. Targeted School Screening for Adolescent Major Depressive Disorder

The primary goal of the proposed study is to compare the effectiveness of universal school based screening for adolescent major depressive disorder to the current school process of targeted screening based on concerning behavior.

The prevalence of annual major depressive disorder (MDD) episodes has increased by greater than 50% from 2008 to 2015 among US adolescents. Paralleling the rise in MDD, suicide is now the 2nd leading cause of adolescent deaths. Despite the US Preventive Services Task Force (USPSTF) 2009 endorsement of universal screening for adolescent MDD in primary care, MDD screening occurs in less than 2% of office visits.

The primary goal of the proposed study is to compare the effectiveness of universal versus targeted adolescent MDD screening in a school setting. Universal screening was chosen to be conducted in schools because, compared to medical settings; schools are more likely to regularly engage with adolescents.

The hypothesis is that universal school-based screening with the validated Patient Health Questionnaire (PHQ) will result in increased rates of MDD screening, identification and treatment engagement. The Penn State team brings a breadth of experience in pediatrics, community-engaged research, adolescent health, psychiatry and engagement with minority populations.

Eligibility Criteria:
Inclusion Criteria:

* Students in grades 9-12 at 14 public schools in Pennsylvania. This is a change from the originally anticipated 16 schools, as 2 were unable to continue participation. Anticipated enrollment numbers will be updated once the data are finalized.

HRSA funding for primarily rural school districts (only one is urban). PCORI funding for urban school districts.

Exclusion Criteria:

* Students whose parents complete the opt-out consent
* Students not enrolled in one of the participating schools
* Students not in grades 9-12
* Students with disabilities that are deemed unable to participate by the school district