cyrilzakka/clinical-trials huggingface dataset:
12-hour Time Limited Feeding in Critical Care

This study is being done to assess the feasibility and safety of a time-restricted 12-hour enteral feeding protocol (experimental group) in comparison to a standard-of-care, 24-hour enteral feeding protocol (control group) in critically ill patients. Investigators hope to gain knowledge about how these feeding schedules affect feeding tolerance, blood sugar control, and other factors affecting critically ill adult patients.

* Investigators expect that the 12-hour feeding protocol will be tolerated similarly to the 24-hour feeding protocol and will not result in a greater number of adverse events related to feeding.
* Investigators expect that the proportion of participants in both groups receiving at least 75% of their estimated nutrition needs will be similar.

Investigators will test a 12-hour time-restricted feeding (TRF12) protocol in critically ill adults and compare this to a standard-of-care, 24-hour continuous feeding (CONT24) schedule. Time-restricted feeding (TRF) is form of intermittent fasting involving eating within a consistent, shortened period each day, following by fasting for at least 12 hours daily. TRF may improve glycemic control, blood pressure, and circadian rhythms in metabolism relative to feeding over a longer period. In critically ill patients, most facilities feed enterally over 24-hours which may exacerbate sleep disturbances and post-intensive care syndrome. In addition to safety and feasibility measures, this 10-day trial will gather preliminary data regarding how these feeding protocols each affect glycemic control, sleep, and long-term effects of critical care, such as delirium.

Eligibility Criteria:
Inclusion Criteria:

* Adults (≥18 years of age)
* With critical illness (hospitalized in an intensive care unit with a status of "ICU")
* Who have received orders for continuous enteral nutrition

Exclusion Criteria:

* "Comfort Measures Only" status
* Have orders to receive trickle feedings (feeding rate ≤10mL/hr)
* Recent surgical procedure on the GI tract (within previous 5 days at time of recruitment) or admission for GI bleed
* Receiving continuous sedation
* Expected to undergo a procedure requiring removal of study devices in the three days following enrollment
* History of malabsorptive bariatric surgery
* Admitted for a burn injury
* Known intolerance to feeding rates \>100mL/hr
* Current diagnosis of pancreatitis, ileus or gastroparesis (only if using a gastrostomy tube)
* Requiring intermittent or continuous renal replacement therapy
* Pregnant or lactating
* On an intermittent feeding schedule
* Nutritional needs would require a rate higher than 120mL/hr on TRF12 protocol
* Lack of clearance by primary physician
Treatment of Schizophrenic Patients With Ziprasidone

To determine whether ziprasidone provides good efficacy and tolerability in the treatment of schizophrenic Greek patients.

Sampling Method Details: Non-interventional study (subjects chosen by physician in accordance to their usual practice).

Eligibility Criteria:
Inclusion Criteria:

* Usual clinical practice of physician

Exclusion Criteria:

* None
MRI Assessment of Pulmonary Edema in Acute Heart Failure

Researchers are testing a more accurate way to measure how much fluid is in the lungs (also called pulmonary edema, or "increased lung water") in people with Heart Failure (HF) using MRI (Magnetic Resonance Imaging). There is little known about the exact level of lung water in patients with AHF or how these levels change from the time of hospital admission to discharge. The purpose of this research study is to measure the lung water in patients hospitalized for HF, to determine the change in lung water over the course of hospitalization and treatment, and to find out if lung water levels can predict if patients are higher or lower risk for returning to the hospital or dying from heart failure.

Heart failure is a condition where the heart is unable to pump enough blood to meet the body's needs and Acute Heart Failure is a sudden worsening of this condition. It is associated with many symptoms but most commonly includes shortness of breath due to pulmonary edema (or increased "lung water").

A physical exam and chest x-ray are commonly used to diagnose AHF and estimate the amount of increased lung water in patients with AHF. This study will use images from MRI (Magnetic Resonance Imaging) scans to obtain a more accurate measurement of the increased lung water in AHF patients. Lung water will be measured via MRI at hospital admission and discharge to find out the change in lung water over the course of hospitalization and treatment. The investigators will collect NT-proBNP and perform a chest x-ray upon hospital admission and again upon discharge, if not already done as part of usual care. The investigators will follow medical records for up to 5 years after hospitalization to see if the accurate lung water measurements obtained in hospital can predict long term outcomes. This is a multi-centre project and a total of 300 patients will be recruited to participate.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older and willing/able to provide informed consent
* patients being treated for acute heart failure (including those patients with both reduced and preserved ejection fraction)
* patients receiving medical therapy for pulmonary edema by current standard of care (including oral or IV diuretics)
* patients identified within 48 hours of initiation of medical therapy for pulmonary edema, defined as the time of first diuretic (IV or PO) or escalation of existing diuretic therapy administered within the ED or hospital

Exclusion Criteria:

* contraindication to MRI
* patient too critically ill/unstable as per the clinical care team for transport to MRI scanner within the required scanning window
* moderate to severe dementia
Sexuality of Women With Pelvic Cancer

This study aims to study in patients with cancer of the cervix or the body of the uterus, or the ovary between the time of diagnosis and 3 months after the end of the last treatment: the evolution of the relationship of couple, and more particularly of communication (verbal and non-verbal) concerning sexuality, before and during cancer.

The representations associated with sexuality and cancer seem antinomic: wellbeing / death, and yet combine in the experience of cancer. The latter has an impact on sexuality in terms of satisfaction or sexual activity and on the relationship in terms of support.

In addition, various studies show the psychological impact of treatments on the couple's relationship or the body image of women with cancer. Their abilities to seduce are affected and explain the decrease of their sexual activity during the treatments: a communication, valuing the femininity, would it then facilitate the relations of couple? There is no work that considers sexuality in a systematic way (sexual act and verbal and non-verbal communication) and apprehends its link with the evolution of the relationship, from the diagnosis of cancer to the end of treatments.

This study aims to study in patients with cancer of the cervix or the body of the uterus, or the ovary between the time of diagnosis and 3 months after the end of the last treatment: the evolution of the relationship of couple, and more particularly of communication (verbal and non-verbal) concerning sexuality, before and during cancer.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Life in a couple or single with a regular partner for at least 3 months
* Cancer of the cervix or uterine body or ovarian cancer, in first diagnosis and treatment
* Whatever the stage of cancer
* Curative treatment
* Support in one of the participating centers
* Possible follow-up of all stages of the research

Exclusion Criteria:

* Presence of metastases
* History of other cancer
* History of severe psychiatric illness
Open Multi-centre Investigation to Evaluate Signs and Symptoms of Local Inflammation/Infection on Chronic Ulcers and Partial Thickness Burns When Using Mepilex Border Ag as an Anti-microbial Wound Dressing

The purpose of this study is to evaluate the change in signs of inflammation/local infection when Mepilex Border Ag is used in normal clinical practice when used on chronic ulcers (venous leg, diabetic foot and pressure ulcers) and partial thickness burns in need\* of topical antimicrobial treatment according to the physician.

The investigation is designed as an open, non-controlled, post-marketing clinical follow-up. Subjects with chronic ulcers or partial thickness burns (including donor sites) at 2 sites will be included. Each subject with a chronic ulcer will be seen once a week for a maximum of 4 weeks or until desired treatment effect is obtained, whichever occurs earlier. Each subject with a partial thickness burn/donor site will be followed once a week for a maximum of 3 weeks or until desired treatment effect is obtained, whichever occurs earlier. All dressing changes will be done according to clinical routine practices and will follow IFU (instruction for use)

Eligibility Criteria:
Inclusion Criteria:

* Subject with a chronic ulcer (venous leg, diabetic foot and pressure ulcers) or a partial thickness burn where an antimicrobial action is indicated\* as judged by the investigator
* Male or female, 18 years and above, both in- and out-patients
* Signed Informed Consent Form

Exclusion Criteria:

* Wound size equal to or above 9.5x15cm for the wound/burn to be included in the investigation
* Subject not expected to follow the investigation procedures
* TBSA \> 10% (partial thickness burns only)
* HbA1C value \> 7.2. (To be measured if BMI \> 30)
* Pregnant and breastfeeding women
* Pressure ulcers deeper than stage 3
* Deep pressure ulcers in need of a filler
* Subjects with known sensitivity to silver or any other dressing materials
* Subjects receiving radiation treatment or examinations e.g. X-ray, ultrasound, diathermy or Magnetic Resonance Imaging
* Subjects using oxidising agents such as hypochlorite solutions or hydrogen peroxide
* Subjects previously included in this investigation
* Subjects included in other ongoing clinical investigation at present or during the past 30 days
Aspects of Vulnerability of People Living with HIV in the Alpine Arc Region

HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the general population. Few studies of metropolitan cohorts investigated precariousness as an independent risk factor for mortality. The investigators chose to consider the vulnerability of people living with HIV (PLWHA) through the measurement of a validated French quantitative score, called EPICES ("Évaluation de la précarité et des inégalités de santé dans les centres d'examens de santé ", Evaluation of precariousness and health inequalities in health examination centers).

HIV infection in France has become a chronic disease and treatment has allowed patients to increase their life expectancy. However, these promising results suffer from a very large variability within the socio-epidemiological subgroups, and life expectancy at 20 years of age is still one third lower than in the general population. Few studies of metropolitan cohorts investigated precariousness as an independent risk factor for mortality. The investigators chose to consider the vulnerability of people living with HIV (PLWHA) through the measurement of a validated French quantitative score, called EPICES (Evaluation of precariousness and health inequalities in health examination centers). Using a self-administered questionnaire administered during an annual follow-up visit to an infectious disease specialist, the investigators seek to define in the alpine arc region in france, socio-demographic data associated with greater precariousness among PLWHA.

Eligibility Criteria:
Inclusion Criteria:

* Any person living with HIV presenting for consultation with their infectious disease referrer.
* Patient followed for at least 6 months for their HIV infection
* Patient with undetectable or detectable HIV viral load
* Patient of legal age at the time of the study
* Patient informed of the study and having expressed no objection to the collection of health data

Exclusion Criteria:

* Patient opposed or unable to express opposition to participation in the study
* Patient is a minor at the time of the study
* Patient taking antiretroviral therapy for less than 6 months
Prognostic Biomarkers in Predicting Mortality in Respiratory Patients With Ventilator-Associated Pneumonia

The aim of this study is to evaluate prognostic efficiency RDW and NLR for mortality prediction in respiratory patients with VAP.

Ventilator-associated pneumonia (VAP) is the most common nosocomial infection. VAP continues to be a leading cause of morbidity and mortality in the nosocomial setting. Red cell distribution width (RDW) and neutrophil-lymphocyte ratio (NLR) are prognostic factors to mortality in different diseases.

Eligibility Criteria:
Inclusion Criteria:

* Respiratory failure needs mechanical ventilator support \> 48 hrs. VAP was defined as an acute lower respiratory tract infection in mechanically ventilated patient \> 48 hrs with a new or progressing infiltrate on chest radiograph and who met at least two of the following clinical criteria: body temperature \>38°C or \<36°C with no other recognized cause, white blood cell count \>10,000 /mm3 or \<5000 /mm3, or a macroscopically purulent tracheal aspirate
* Only the first VAP episode was included

Exclusion Criteria:

* Neutropenia (\< 500 cells/ml) before the development of VAP.
* Conditions are known to influence total and differential WBC counts such as chronic inflammatory conditions, hematologic disorders, history of chemotherapy, or radiotherapy within 4 weeks before enrollment.
* Conditions are known to affect RDW as anemia due to nutritional deficiency (ie, iron, vitamin B12, and folic acid).
* Patients with HIV/AIDS
A Comparison of the Efficacy of Interdental Floss to Water Flosser Around Dental Implants

The primary objective of this study was to compare two different interproximal devices, water flosser and dental floss around implants in several clinical parameters

This study was a randomized, controlled clinical trial in a single center. All clinical measurements were taken by a single blinded investigator (Periodontal Resident) while a single dental hygienist was responsible for prophylaxis and delivery of oral hygiene instructions to the study participants. At each appointment 5 clinical parameters were recorded: Full Mouth Plaque Score (FMPS) and Quigley-Hein plaque index (QHI) of the implants after the use of a disclosing solution, Probing Depth (PD), Bleeding on Probing (BOP) of the study implants recorded at 6 sites (distobuccal, mid-buccal, mesiobuccal, distolingual, mid-lingual and mesiolingual) using a UNC 12 Colorvue probe and the width of the keratinized tissue (KT) at the buccal surface of the study implants. Randomization between the 2 groups was achieved using computerized randomization scheme (https://en.calc-site.com/randoms/grouping).

Group A (control): patients were instructed to floss with TePe Bridge and Implant Floss once a day, preferably at nighttime.

Group B (test): patients were provided with Waterpik Water Flosser and instructed to water floss around the implant once a day, preferably at nighttime.

During each appointment the study investigator measured clinical parameters and participants received oral hygiene instructions (OHI) and supportive periodontal therapy (SPT) by a single dental hygienist. Once the study was concluded patients were asked to fill-out a 2 question questionnaire inquiring how much they liked their interproximal device and how easy it was to be used in a scale 1 to 5.

Eligibility Criteria:
Inclusion Criteria:

* Patients that present with at least a single implant with a screw-retained crown
* Patients with general good health that do not have a condition contra-indicating routine dental treatment
* Patients that are compliant with the research protocol and methods
* Patients that have read, understood and signed the informed consent form

Exclusion Criteria:

* Patients with implants with cemented crowns
* Patients with any contact hypersensitivity to the related materials used in the study
* Tobacco users (vaping included)
* Patients unwilling to sign the informed consent form or follow the protocol of the study
A Study of Carboplatin Plus Etoposide With or Without Atezolizumab in Participants With Untreated Extensive-Stage (ES) Small Cell Lung Cancer (SCLC)

This randomized, Phase I/III, multicenter, double-blinded, placebo-controlled study was designed to evaluate the safety and efficacy of atezolizumab (anti-programmed death-ligand 1 \[PD-L1\] antibody) in combination with carboplatin plus (+) etoposide compared with treatment with placebo + carboplatin + etoposide in chemotherapy-naive participants with ES-SCLC. Participants will be randomized in a 1:1 ratio to receive either atezolizumab + carboplatin + etoposide or placebo + carboplatin + etoposide on 21-day cycles for four cycles in the induction phase followed by maintenance with atezolizumab or placebo until progressive disease (PD) as assessed by the investigator using Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1). Treatment can be continued until persistent radiographic PD or symptomatic deterioration.


Eligibility Criteria:
Inclusion Criteria:

* Histologically or cytologically confirmed ES-SCLC (per the Veterans Administration Lung Study Group \[VALG\] staging system)
* No prior systemic treatment for ES-SCLC
* Eastern Cooperative Oncology Group performance status of 0 or 1
* Measurable disease, as defined by RECIST v1.1
* Adequate hematologic and end organ function
* Treatment-free for at least 6 months since last chemo/radiotherapy, among those treated (with curative intent) with prior chemo/radiotherapy for limited-stage SCLC

Exclusion Criteria:

* Active or untreated central nervous system (CNS) metastases as determined by computed tomography (CT) or magnetic resonance imaging (MRI) evaluation
* Malignancies other than SCLC within 5 years prior to randomization, with the exception of those with a negligible risk of metastasis or death treated with expected curative outcome
* Pregnant or lactating women
* History of autoimmune disease
* History of idiopathic pulmonary fibrosis, organizing pneumonia, drug-induced pneumonitis, idiopathic pneumonitis, or evidence of active pneumonitis on screening chest CT scan. History of radiation pneumonitis in the radiation field (fibrosis) is permitted.
* Positive test result for human immunodeficiency virus (HIV)
* Active hepatitis B or hepatitis C
* Severe infections at the time of randomization
* Significant cardiovascular disease
* Prior treatment with cluster of differentiation (CD) 137 agonists or immune checkpoint blockade therapies, anti-programmed death-1 (PD-1), and anti-PD-L1 therapeutic antibody
* History of severe (or known) hypersensitivity to chimeric or humanized antibodies or fusion proteins or any component of atezolizumab formulation.
Near Patient Molecular Testing in Sepsis

The purpose of the study is to evaluate the real-time performance of a new host response test (SeptiCyte RAPID) for differentiating sepsis from non-infection/systemic inflammatory response syndrome among patients suspected of sepsis within the first 24 hours of intensive care unit (ICU) admission.

The ability of SeptiCyte RAPID to differentiate sepsis from infection-negative systemic inflammation will be determined using retrospective physician diagnosis performed by an external panel of three physicians not involved with the care of the patients.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old on the date of ICU admission
2. Systemic Inflammatory Response Syndrome (SIRS) present, as defined by the presence of two or more of the following:

   1. Temperature \> 38°C or \< 36°C
   2. Heart Rate \> 90 beat/min
   3. Tachypnea \> 20/min or PaCO2 \< 32 mmHg
   4. WBC count \> 12 000/mm3 or \< 4 000/mm3 or \> 10% immature neutrophils (bands)
3. Consent to study inclusion, either by patient or legal surrogate before study-related sample processing
4. Study sample collection within 24 hours of ICU admission order

Exclusion Criteria:

1. Age less than 18 years old on the day of ICU admission
2. No order to admit to ICU
3. Not physically admitted to ICU
4. Commencement of non-prophylactic antibiotics ≥ 24 hours prior to ICU admission
5. Study sample collection \> 24 hours from ICU admission order
6. No clinical cultures or serologic tests obtained when sepsis was suspected
7. Elective cardiac surgery patients with an expected duration in ICU of less than 24 hours
8. Transfer from another ICU where subject was admitted for ≥ 24 hours.
Clinical Decision Support System to Define 30 Day Adverse Clinical Events for Emergency Department Acute Coronary Syndromes

Acute coronary syndromes are among main complains for patients presenting to emergency department. Risk classification systems are used to classify patients to appropriate risks and help physicians manage diagnosis strategies and treatments. Purpose of this study is to develop a clinical decision support system for patients presenting to emergency department with the help of statistical machine learning.

Acute coronary syndromes are among main complains for patients presenting to emergency department and create a burden to emergency departments and hospitals. Risk classification systems were developed and used to classify patients to appropriate risk groups. According to risk classification, different diagnosis and treatment modalities can be used and help physicians manage diagnosis strategies and treatments. Purpose of this study is to develop a clinical decision support system for patients presenting to emergency department with the help of statistical machine learning.

Eligibility Criteria:
Inclusion Criteria:

* Presenting to emergency department with acute chest pain consistent with acute coronary syndrome

Exclusion Criteria:

* Patients with less than 18 years old
* Patients presenting with ST-segment elevation myocardial infarction
* Patients presenting with other causes of acute chest pain (pneumothorax, pulmonary -embolism, aortic dissection
* Decline to participate in study
Gender Differences in Prevalence of Undiagnosed Diabetes in ACS

The primary goal of this study is to measure the prevalence of undiagnosed pre-diabetes/diabetes among women hospitalized with acute coronary syndromes (ACS) compared to men. Inpatients with confirmed ACS (and no known prior history of diabetes) are invited to return to the Yale Hospital Research Unit 6-8 weeks after hospital discharge for an oral glucose tolerance test to identify individuals with pre-diabetes and diabetes.


Eligibility Criteria:
Inclusion Criteria:

* acute coronary syndrome
* age \> 30 yrs

Exclusion Criteria:

* previously diagnosed diabetes
* ACS due to substance abuse or trauma