cyrilzakka/clinical-trials huggingface dataset:
Study of Immunosuppression Biomarkers Acquired in Patients Hospitalized in Intensive Care Unit

Open-label, non-randomized, prospective, single center, observational, translational study

The aim of this trial is to study immunosuppression biomarkers in patients hospitalized in intensive care unit in comparison to non-septic patients.

Prevalence of immunosuppression acquired in intensive care unit will be studied and patients most likely to develop nosocomial infection will be early identified

Eligibility Criteria:
Inclusion Criteria:

* Patient older than 18 years old
* Patient hospitalized in intensive care unit for any reason
* Patient with infection started less than 5 days before admission
* Patient with mechanical ventilation or not
* Patient with arterial catheter for an invasive monitoring of blood pressure
* Patient informed about the study protocol and approved to participate.
* Patients hospitalized for a severe bacterial infection (severe sepsis or septic shock)
* Patient hospitalized for a non-infectious disease

Exclusion Criteria:

* Pregnancy
* Advanced immunosuppression defined by proved humoral or cellular impairment by continuous administration of steroids at any dose since more than one month before hospitalization, transplantation, radiotherapy or chemotherapy in the preceding year
* Initiation of an immunosuppressive therapy as chemotherapy, cyclophosphamide or high dose corticotherapy (\>0.5mg/kg/day)
The Patient's First Point of Contact

The overall objective of this observational study is to investigate practices of communication and decision-making during nurses' initial assessment of patients' health problems in primary care, examine working mechanisms in good practices and develop feasible solutions.

The specific aims are:

1. To investigate patients' expectations and experiences with the communication and decision-making during their first contact with a registered nurse (RN) in primary care.
2. To investigate patient-RN communication on the level of patient involvement.
3. To investigate RNs' actual communication, assessments and decision-making, value conflicts and the challenges and strategies they use in prioritizing.
4. To analyse the underlying working mechanisms of good communication practices.
5. To develop methodologies for facilitating efficient processes in assessing, managing, and prioritizing patients in primary care for RNs.

Project PINPOINT aims for a prospective multicenter study, using various methods for data collection and analysis.


Eligibility Criteria:
Inclusion Criteria:

* Registered Nurses at primary care centres and patients seeking primary care for a new health concern or a new episode of a problem

Exclusion Criteria:

* Patients visiting the primary care nurse with a chronic or continuous health problem
Using Rapid Cycle Trials to Increase Patient Engagement in the Community Health Worker Program in the Emergency Department

This study is evaluating the effectiveness of the post-discharge program facilitated by the Community Health Worker program in the Emergency Department at NYU Langone Health Hospital - Brooklyn and testing different strategies to increase patient engagement in the program.


Eligibility Criteria:
Inclusion Criteria:

* Patients who present for a visit at the Emergency Department at NYU Langone Brooklyn Hospital and who qualify for the Community Health Worker program assessment and enrollment.

Exclusion Criteria:

* N/A
Normative Database and Test-Retest Reliability for BrainCheck Assessments

The purpose of this study is to collect normative test values and demographic information for normative and referential data for a rapid, portable, computerized neurocognitive testing device from healthy adults 50 and older.

BrainCheck's battery of 12 cognitive assessments will be used in this study, which aims to measure a variety of cognitive domains (memory, attention, mental flexibility, executive function, processing speed, balance, reasoning, visuospatial construction, language, and visual hallucinations).

With the decline in cognition occurring at a quicker rate at older ages, this study aims to collect additional data from healthy older adults to better capture the normative distribution among these age groups from existing and new assessments.

Eligibility Criteria:
Inclusion Criteria:

* Aged 50 or older
* Willing and able to comply with study requirements and activities

Exclusion Criteria:

* TBI within the last 6 months
* Neurosurgery within the last month
* Experienced a stroke
* Self reported neurological condition (including mild neuropsychological impairment, dementia, Parkinson's disease, amyotrophic lateral sclerosis, Multiple sclerosis, or long-covid)
Hypoactive Sexual Desire Disorder in Males

The purpose of this study is to determine if the study drug will increase sexual desire in men with HSDD. Half of the participants will take ADDYI while the other half will receive a placebo (a look-alike pill with no medicine).

This pilot randomized placebo controlled study will include 60 men (30 treatment and 30 placebo). ARM 1 will take flibanserin 100mg orally every night and ARM 2 will take a placebo orally every night.

There will be four study visits and the study duration is approximately 4 months. Participants will have physicals at each visit. Blood draws for tests will be done at 3 visits and up to 4 questionnaires will completed at each visit. Study drug will randomized.

Eligibility Criteria:
Inclusion Criteria:

* Men age 18 through 69 years old
* Men who are distressed by their low libido as defined by SDI-2, and SCI-M questionnaires. (Appendices A,C)
* Men who are not depressed as defined by PHQ-9 (Patient Health Questionnaire) score of 9 or less. (Appendix D)
* Men with good erectile function as defined by IIEF greater than 22
* Men with normal testosterone and liver function values (may be on testosterone therapy)
* Men who are satisfied in their relationship or with their partners
* Men or their female partners must be willing to use one form of contraception throughout the study and 30 days after final study visit.
* Willing to give informed consent

Exclusion Criteria:

* Hypogonadal patients (less than 350 ng/dL)
* IIEF-EF less than 22
* CYP3A4 and CYP2C19 inhibitors Use of moderate or strong CYP3A4 inhibitors is prohibited for the duration of the trial, and if such medication becomes necessary, flibanserin treatment must be suspended until 2 weeks after the last dose of the CYP3A4 inhibitor
* Hepatic impairment not greater than 1.5 upper limit of normal of AST/ALT
* Men with normal to high libido
* Depressed patients as assessed by the PHQ-9 questionnaire as defined as 10 or greater.
* Men who are stressed or fatigued as determined by the PI
* Men with partners who have low libido as determined by the PI
* Men with pre-existing conditions that might predispose to hypertension
* Men who are not willing to meet the requirements for drinking alcohol during their participation in the study
* Men who are taking digoxin
First Line gastroeSOphageal metastatiC canceR primAry and disTant (if Oligometastatic) lEsions-directed Radiotherapy, a Multicentric, Phase III, Randomized Controlled Trial

The aim of the study is to evaluate the efficacy of radiotherapy on the primary site of gastroesophageal cancer and extracranial stereotactic radiotherapy on metastases before the use of standard systemic therapy, in cases of limited disease burden (in the experimental group), compared to the standard group, which does not receive radiotherapy. This prospective, multicenter, randomized trial aims to evaluate the efficacy of the unconventional approach versus the conventional one in increasing the percentage of asymptomatic patients due to the direct effect of the primary tumor or metastases. "Randomized" means that the assignment to one of the treatment groups mentioned above will be random, not influenced by the physician or the patient's condition. Therefore, your participation in either of the two treatments under study will be assigned randomly and not predetermined. This randomness is crucial for a proper analysis of the results at the end of the study, which will help clarify whether there are differences between the two proposed treatments. This also means that you may not receive direct benefits from participating in this study, as it is a research study.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with gastroesophageal cancer (i.e.: esophagus, gastroesophageal junction, stomach), for both major squamous cell (SCC) and adenocarcinomatous (ADK) histologies, metastatic, candidate for first-line standard systemic treatment; either newly diagnosed in metastatic stage or first progression to metastasis.
* Obtaining informed consent.
* Patients \>18 years of age
* ECOG 0-2
* Performance of imaging (CT with mdc, MRI with mdc, CT-PET with appropriate tracer) adequate for baseline local and systemic staging and likely to be similarly repeatable at 6 and 12 months after randomization
* Confirmation at the time of randomization, by the Radiation Therapy Center, that all potentially planned treatments can be performed for the patient (if enrolled in experimental arm) within a maximum of 25 days total before referral to the Medical Oncology Center for systemic therapy

Exclusion Criteria:

* Metastatic picture of line following the first
* Technical or organizational inability to the eventual deadline for radiation treatments within 25 days of randomization
* Inability to express independent consent to treatments
* Pregnancy
* Patient in hospice or with prognosis \< 6 months
* Predicted unavailability for follow-up at 6 months
* Absence of adequate or likely non-repeatable pretreatment imaging study at 6 and 12 months
* Previous radiation therapy
* Previous radiometabolic therapy
* Inability to maintain treatment position for SBRT
* Symptomatic emergent or other presentation precluding study development as planned (e.g., epidural compression of the spinal cord or cauda equina)
* Previous chemotherapy, immunotherapy or target therapy
Predicting Radiological Extranodal Extension in Oropharyngeal Carcinoma Patients Using AI

Development and validation of a model that predicts rENE from radiological imaging using annotated / labeled scans by means of deep learning

Oropharyngeal squamous cell carcinoma (OPSCC) is a rare cancer (incidence \~700 per year in the Netherlands), originating in the middle part of the throat. In OPSCC, nodal status is an important prognostic factor for survival. In the clinical TNM (tumor node metastases) system, nodal status is mainly defined by the size, number and laterality of nodal metastases. In surgically treated patients the pathological TNM classification includes the presence of pathological extranodal extension (pENE). pENE is a predictor for poor outcome and also an indication for the addition of chemotherapy to postoperative radiation. However, most patients with OPSCC are treated non-surgically by means of radiation or chemoradiation and thus information about pENE is lacking. Recently, extranodal extension on diagnostic imaging has been associated with prognosis in OPSCC patients. It is anticipated that in the near future radiological ENE (rENE) may be included in the cTNM classification system for refinement of outcome prediction in patients with nodal disease. The diagnosis of rENE on radiological imaging is new and not trivial and we hypothesize that Artificial Intelligence (AI) may support the radiologist in detecting rENE. In this study we aim to develop and validate a model that predicts rENE from radiological imaging using annotated / labeled scans by means of deep learning

Eligibility Criteria:
Inclusion criteria:

* Non-metastatic (M0) node-positive HPV+ and HPV- oropharyngeal carcinoma
* Treated between 2008 to 2019
* Curative intent
* Radiation only or concurrent chemoradiation
* Modern treatment modality: IMRT / VMAT
* diagnostic/staging image scanning protocols available (contrast-enhanced CT with 2-3 mm slice thickness and/or MR with 3 mm slice thickness)

Exclusion criteria:

* removal of lymph node (LN) (excisional biopsy or neck dissection \[ND\]) prior to staging CT/MR scan
* no available imaging within 2 months prior to radiotherapy (RT)"
An Italian Experience on Grade 3b Follicular Lymphoma

Study purpose is to evaluate baseline clinical data, outcome after front-line Rituximab containing chemotherapy and survival in patients with grade 3b Follicular Lymphoma.

Also an histological central review is planned in order to re-assess baseline diagnosis according to new 2016 World Health Organization (WHO) criteria.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of grade 3b Follicular Lymphoma
* Age \> 18 years
* Front-line treatment with Rituximab containing chemotherapy
* Availability of histological sample for central review

Exclusion Criteria:

* Other lymphoma diagnosis
FDG-PET Imaging in Young Cystic Fibrosis Patients

The purpose of this research is to determine how a person's lungs will uptake \[18F\]fluorodeoxyglucose (FDG), as measured with positron emission tomography (PET) scanning in young cystic fibrosis (CF) patients.

Our recent study in CF adults, supplemented by recent pre-clinical and clinical studies by our group suggests that labeled fluorodeoxyglocose-based positron emission tomography (FDG-PET) imaging may be a valuable quantitative biomarker of lung inflammation. The proposed study would validate our earlier findings, but in a younger patient population. The implications of such a test could be highly significant for both the testing of promising new anti-inflammatory agents and for patient management decisions. To capitalize on this exciting opportunity, the critical next step is to show that we can identify a cohort of young CF patients with both stable lung function and normal (or near normal) FDG-PET imaging studies. Similar patients, then, would become the subjects for a future prospective cohort study to determine if FDG-PET imaging can in fact serve as a predictor of future changes in lung function.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of cystic fibrosis
* Age 12 to 21 years old, of either gender, any race or ethnicity
* Stable recent pulmonary status (defined as no new pulmonary symptoms, new antibiotic use, or hospitalization for pulmonary symptoms for at least 1 month).
* We will permit patients treated with the macrolide antibiotic, azithromycin, to participate in this study. Azithromycin has recently become a virtual standard of care in CF, based on small but reproducible improvements in pulmonary function over 4 months of treatment with this drug. The mechanism of benefit is uncertain, but an anti-inflammatory effect has been suggested. The high prevalence of use means that a study without azithromycin would likely require a wash-out period, without data about the appropriate duration for such a wash-out, or whether inflammatory markers would reverse during that time.

Exclusion Criteria:

* Failure to obtain informed consent
* Positive pregnancy test or lactation
* Currently enrolled in another study involving radioisotopes or an investigational drug
* Recent (within 30 days of screening) hospitalization for any reason
* New antibiotic use (within 30 days of screening).
* Patient incapable of lying still and supine within the PET/computed X-ray tomography (CT) scanner for 90 minutes.
* Patient incapable of completing other testing procedures (e.g., PFT, induced sputum)
* Patient with serum glucose greater than 150 mg/dl at time of PET imaging study
* Patient incapable of fasting for 4 to 6 hrs prior to PET imaging study
Measuring Adverse Pregnancy and Newborn Congenital Outcomes

The purpose of this study is to develop a pharmacovigilance (PV) surveillance program to monitor adverse pregnancy and infant outcomes, including the presence of congenital abnormalities, among HIV-positive and HIV-negative women and their infants at clinical sites affiliated with the International Epidemiology Databases to Evaluate consortium (IeDEA).

In part 1 of this study, the investigators will use a mixed prospective and cross-sectional cohort study design to implement a PV program at two health facilities affiliated with the Academic Model Providing Access to Healthcare (AMPATH) in western Kenya. The investigators will analyze these data to examine any associations between antiretroviral treatment (ART) and (a) pregnancy and (b) infant/birth outcomes. In part 2, the investigators will create standardized protocols and data exchange standards within IeDEA to enable the merging and analysis of multiregional IeDEA PV data. This will include establishing a Data Coordinating Center based at Indiana University (IU) to serve as a hub for collecting, disseminating and archiving data from the study in Kenya as well as data collected through a similar, ongoing study at health facilities in South Africa affiliated with IeDEA. This study will establish a multiregional PV infrastructure within IeDEA that can be further scaled within the broader IeDEA network.

Eligibility Criteria:
C1. Prospective recruitment of HIV+ and HIV- pregnant women enrolling in ANC at the site:

Inclusion criteria for women

1. Pregnant and enrolled in ANC at the study site;
2. Understands English or Swahili.

Exclusion criteria for women a. Any physical or mental disability that prevents the woman from providing informed consent

Inclusion criteria for infants

a. All infants at any gestational age who are born to enrolled women will be included Exclusion criteria for infants (none)

C2. Data collection for all deliveries at the site:

Inclusion criteria for women a. Woman delivers at the site and the delivery is registered at the site

Exclusion criteria for women (none)

Inclusion criteria for live/stillborn infants

a. Infant is delivered at the site and results in the infant/stillbirth being registered at the site

Exclusion criteria for infants (none)

C3. Photos/videos of infants with CAs:

Inclusion criteria for infants

1. The infant is live or stillborn at ≥ 24 weeks estimated gestational age
2. The infant has a suspected CA on surface exam

Exclusion criteria for infants (none)
A Study of Mirikizumab (LY3074828) in Participants With Moderate to Severe Plaque Psoriasis

The main purpose of this study is to evaluate the efficacy of the study drug mirikizumab in participants with moderate to severe plaque psoriasis.


Eligibility Criteria:
Inclusion Criteria:

* Present with chronic plaque psoriasis based on an investigator confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to baseline and meet the following criteria:

  * plaque psoriasis involving ≥10% body surface area (BSA) and absolute PASI score ≥12 in affected skin at screening and baseline
  * sPGA score of ≥3 at screening and baseline
* Candidate for biologic treatment for psoriasis.

Exclusion Criteria:

* Have a history or presence of cardiovascular, respiratory, hepatic, gastrointestinal, endocrine, hematological, neurological, or neuropsychiatric disorders or any other serious and/or unstable illness that, in the opinion of the investigator, could constitute a risk when taking investigational product or could interfere with the interpretation of data.
* Breastfeeding or nursing (lactating) women.
* Have had serious, opportunistic, or chronic/recurring infection within 6 months prior to screening.
* Have received live vaccine(s) (included attenuated live vaccines) within 1 month of screening or intend to during the study.
* Have any other skin conditions (excluding psoriasis) that would affect interpretation of the results.
* Have received systemic nonbiologic psoriasis therapy or phototherapy within 28 days prior to baseline.
* Have received topical psoriasis treatment within 14 days prior to baseline.
* Have received anti-tumor necrosis factor (TNF) biologics, or anti-interleukin (IL)-17 targeting biologics within 8 weeks prior to baseline.
* Have previous exposure to any biologic therapy targeting IL-23 (including ustekinumab), either licensed or investigational (previous briakinumab use is permitted).
Improving Bone Health in Adolescence Through Targeted Behavioral Intervention

School based educational intervention to educate on bone health among Hispanic, Asian or non-Hispanic white girls between 10-13 years with end points of knowledge gained, calcium intake and bone density in . The hypothesis was that the educational program would increase knowledge, improve dairy food and calcium consumption and enhance bone health in this population. A secondary hypothesis was that lactose maldigestion would be an impediment to improved dairy food consumption.

A targeted behavioral intervention to improve calcium intake and bone mass was conducted at middle schools in 6 states. The primary outcomes of bone mass and dietary calcium were assessed among Asian, Hispanic, or non-Hispanic white girls between 10 -13 y. Lactose maldigestion (LM) was determined by a breath hydrogen test (BHT). Perceived milk intolerance (PMI) and calcium intake were assessed by questionnaires and bone mineral content (BMC) was determined by dual energy X-ray absorptiometry (DXA). Data from 473 girls were used in a multiple linear regression to examine the impact of the intervention while accounting for PMI and LM and adjusting for covariates.

Eligibility Criteria:
Inclusion Criteria:

Middle schools within one-hour driving time of one of the designated DXA measurement sites were eligible to participate in ACT if their student population had a higher proportion of Asian or Hispanic students than the respective state's average. - Girls recruited for evaluation measures were limited to those being at least 75% Asian, Hispanic or non-Hispanic White based on the race/ethnicity of their biological parents.

Exclusion Criteria:

-
Management of Miller Class I & II Gingival Recession

Management of Miller class I \& II gingival recession using coronally advanced flap combined with conventional de-epithelialized free gingival graft versus coronally advanced flap combined with abrasive de-epithelized connective tissue graft Null hypothesis: In patients with Miller class I and II gingival recession, there is no difference between coronally advanced flap with conventional de-epithelialized free gingival graft and coronally advanced flap with abrasive de-epithelized connective tissue graft in recession depth reduction.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years.
* Systemically healthy patients.
* Miller's Class I and II recession defects with recession depth ≥ 2mm.
* Presence of identifiable cemento-enamel junction (CEJ).
* Clinical indication and/or patient request for recession coverage.
* Smoking ≤ 10 cigarettes/day.
* Cooperative patients able and accept to come for follow up appointments.

Exclusion Criteria:

* Pregnant females.
* Smoking ˃ 10 cigarettes/day.
* Contraindication for periodontal surgery.
* Patients with poor oral hygiene.
* Recession defects associated with caries or restoration as well as
* Teeth with evidence of a pulpal pathology
* Molar teeth
IRIS-Synergy Cohort in the IRIS-DES Registry

The purpose of this study is to evaluate the relative effectiveness and safety of Synergy stent compared to other drug eluting stents.


Eligibility Criteria:
Inclusion Criteria:

* Age 19 and more
* Intervention with Synergy stent
* Agreed with written informed consent form

Exclusion Criteria:

* Intervention with Synergy stent and other drug eluting stent at the same time
* Life expectancy of 1year and under
* Cardiac shock