cyrilzakka/clinical-trials huggingface dataset:
Viral Load Guided Immunosuppression After Lung Transplantation

The VIGILung study is an open-label, randomized, multicenter trial in lung transplant recipients to investigate the safety and efficacy of personalized immunosuppression guided by DNA monitoring of Torque-Teno-Virus (TTV). The aim of the study is to investigate an individual adaptation of the calcineurin inhibitor tacrolimus (tailored calcineurin inhibitor dosing) by a non-invasive biomarker (TTV viral load in whole blood) compared to conventional calcineurin inhibitor dosing. Indicator for toxicity will be the glomerular filtration rate (GFR), which will be estimated using the CKD-EPI formula. 250 patients (age ≥ 18 years) with 21 to 42 days after de novo lung transplantation (bilateral or combined) will be screened as possible subjects eligible for the study. N = 144 patients have to be randomized in two study arms. In Arm 1 tacrolimus doses will be adapted according to the tacrolimus blood level (conventional therapeutic drug monitoring - TDM) and additionally depending on TTV viral load. In Arm 2 tacrolimus doses will be adapted according to TDM.


Eligibility Criteria:
Inclusion Criteria:

1. patients 21 to 42 days after primary de novo lung transplantation (bilateral including combined)
2. age ≥ 18 years
3. tacrolimus based immunosuppression
4. written informed consent
5. detectable TTV load at randomization (\>2,7 log 10)
6. negative serum pregnancy test in women of childbearing potential.
7. women of childbearing capacity must agree to maintain highly effective methods of contraception by practicing abstinence or by using at least two methods of birth control from the date of consent through the end of the study. If abstinence is not practiced, a combination of hormonal contraceptive (oral, injectable or implants) and a barrier method (condom, diaphragm with a vaginal spermicidal agent) has to be used.

Exclusion Criteria:

1. patients after unilateral or re-do lung transplantation
2. history or high-risk of obstructive airway complications after lung transplantation
3. respiratory failure (need for oxygen therapy or ventilation at screening after lung transplantation)
4. inability to undergo transbronchial biopsy
5. advanced kidney failure (GFR CKD-EPI \<30 ml/min/1.73m2 at inclusion and/or current renal replacement therapy at inclusion or randomization
6. advanced liver cirrhosis (CHILD-Pugh Score C) after lung transplantation
7. fluctuating tacrolimus drug levels (less than 20% in target range after transplantation)
8. symptoms of significant mental illness and with inability to cooperate or communicate with the investigator.
9. unlikeliness to comply with the study requirements
10. HIV positivity
11. evidence of unsolved drug or alcohol addiction
12. breastfeeding women
13. simultaneous participation in other clinical trials if not permitted by the steering committee
Effects of Bedside Compared to Outside the Room Case Presentation

Patient case presentations during ward rounds can take place at the bedside or outside the room. The best approach to patient case presentation is yet unclear. Thus, the overall aim of this multicenter, randomized-controlled study is to test the hypothesis that outside the room patient case presentation compared to bedside patient case presentation results in better outcomes across different dimensions including patient understanding and perception of quality of care as well as patient outcomes, physicians' preferences, perception of quality and effectiveness, and timing of the ward rounds, respectively.

Patient-centered care may be defined as "providing care that is respectful of and responsive to individual patient preferences, needs, and values and ensuring that patient values guide all clinical decisions". Involving patients in all steps of the healthcare process is thus important. Yet, best presentation of patients' cases during ward rounds remains unknown. During outside the room patient case presentation, the medical team discusses difficult patient or medical issues in the team, and later presents a "patient-friendly" synthesis to the patient. Bedside patient case presentation, on the other hand, allows a patient to be part of the whole team discussion. Yet, there is concern that patients may be unable to cope with the magnitude of medical information and misunderstandings may occur. Currently, there is equipoise regarding both possibilities of patient case presentation with an important lack of trial data. We thus aim to compare the effect of bedside patient case presentation with outside the room patient case presentation during ward rounds ("Chefarztvisite") on different patient- and physician-related endpoints.

Therefore, this randomized controlled trial aims to test the hypothesis that outside the room patient case presentation compared to bedside patient case presentation results in better outcomes across different dimensions including patient understanding and perception of quality of care as well as patient outcomes, physicians' preferences, perception of quality and effectiveness, and timing of the ward rounds, respectively.

Eligibility Criteria:
Inclusion Criteria:

* Consecutive adult (\>18 years) medical inpatients during their first ward round independently of their underlying disease and reason for hospital stay.

Exclusion Criteria:

1. Patients with cognitive impairment, such as dementia/delirium
2. Patients with paracusia.
3. Patients who do not understand local language(s).
4. Patients already included in this study
Self-Management Interventions Using Mobile Health for the Multimorbid

The purpose of this pilot study is to evaluate the feasibility and impact of delivering mobile health self-management interventions to improve adherence to the prescribed treatment in a multimorbid population returning home after hospital discharge.

The purpose of this three-group repeated-measures randomized controlled trial is to evaluate the use of mobile health (mHealth) self-management technology as a model of care for individuals with multimorbidity. Specifically, this 8-week self-management intervention uses tailored self-management strategies (action planning, goal setting, and individually identified support needs) and mHealth technology for real-time virtual visits, daily messages, and self-monitoring activities. The investigators are testing the additive impact of having the nurse practitioner/community health worker (NP/CHW) team with the mHealth platform (mHealth Plus). The NP evaluates physiological status by evaluating symptoms and tailoring the intervention specific to the individual's multimorbidity while the CHW will assist in recognizing possible solutions to challenging social determinants of health by identifying community resources and guidance in overcoming barriers.

The following specific aims will be addressed:

Aim 1: To evaluate the feasibility of implementing comparative SM interventions (mHealth and mHealth plus virtual visits with a nurse practitioner and community health worker team) in multimorbid individuals by assessing: a) acceptability of each intervention; b) enrollment (recruitment efficiency, attrition, problems and solutions); c) intervention fidelity (delivery, receipt, enactment of the intervention \[benefits and barriers\]); and d) data collection (technological transfer of data, instrument reliability, the time required, missing data).

Aim 2: To examine the impact of delivering the m-Health and m-Health plus interventions compared to standard care (SC) in multimorbid individuals on: a) primary outcome: adherence to disease-specific lifestyle behaviors (e.g. diet and medication, and self-monitoring of physiological measures as needed (e.g. weight blood pressure, blood glucose, oxygen saturation); b) secondary outcomes: health related quality of life; c) patient-reported health status; d) symptom status; and e) healthcare utilization.

Eligibility Criteria:
Inclusion Criteria:

1. multimorbid patients with one of 4 chronic conditions (HF, COPD, diabetes or hypertension) and have at least one other chronic disease (i.e., hypertension, cancer, stroke, heart disease, diabetes, arthritis, hepatitis, current asthma, kidney failure, or COPD),
2. adult patients (age 19 and older)
3. access to smart technology (phone or iPad) and internet access or a phone plan large enough for daily interactions; and d) able to hear, speak and read English.

Exclusion Criteria:

1. major surgery while admitted;
2. discharged to somewhere other than home (e.g., long term care facility);
3. receiving home health services;
4. documented dementia; and
5. life expectancy \<6 months.
YUKON-drug-eluting Stent Below The Knee - Randomised Double-blind Study

The purpose of this study is to compare the effectiveness of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease.

Based on the fact that drug eluting stents have been proven to reduce the restenosis rate in the coronary arteries, we assume that YUKON-BTX-Sirolimus-eluting stent has a superior restenosis rate compared to treatment with uncoated stent in the below-the-knee arteries consecutively. The purpose of this study is to compare the restenosis rate of the treatment with balloon-expandable YUKON-BTX-Sirolimus-eluting stent over the treatment with YUKON-BTX uncoated stent in patients with ischemic infrapopliteal arterial disease. Randomisation will be performed by extremity, that may lead to varying treatments within one patient during the study.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of peripheral arterial occlusive disease as defined by Rutherford 2-5
* De-novo stenosis of \> 70% diameter stenosis in the tibioperoneal trunc, anterior and/or posterior tibial and/or peroneal artery
* Target lesion length of ≤ 45 mm

Exclusion Criteria:

* Coagulation disorder
* Known allergy to contrast medium
* Contraindications to antiplatelet therapy or heparin
Interscalene Brachial Plexus Block to Treat Pain After Clavicular Surgery

The sensory innervation of the clavicle remains an area of debate. Regional nerve blocks aimed at relieving pre- and post-operative pain include the superficial cervical plexus blocks, interscalene blocks and a combined version of the above. In this case study, the investigators aim to describe the protocol used in a university hospital: general anaesthesia with interscalene brachial plexus block, followed by optional iv morphine administration in phase 1 recovery and oral oxycodone on the ward.


Eligibility Criteria:
Inclusion Criteria:

* clavicular fracture with internal reduction
* physical status I - III

Exclusion Criteria:

* contraindication to regional anaesthesia
* history of neck radiotherapy
* patient suffering from chronic pain
* severe respiratory disease
Code of Respect (X-CoRe): Trial of a Multi-level Sexual Assault and Sexual Harassment Prevention Intervention for Active Duty Airmen

The purpose of this study is to examine the efficacy of Code of Respect (X-CoRe) multi-level sexual assault (SA) and harassment (SH) prevention program in improving psychosocial determinants (e.g., knowledge, skills, self-efficacy, attitudes) related to respectful/disrespectful relationships, to examine the efficacy of X-CoRe in reducing SA and sexual harassment SH victimization and to examine the efficacy of X-CoRe increasing bystander behavior and improving unit cohesion and mission readiness by decreasing secondary risk and harmful behaviors (e.g., alcohol misuse, intimate partner violence, suicide ideation). The study will be conducted at at Joint Base McGuire Dix-Lakehurst (JBMDL) located in Burlington County, New Jersey, and participants will be cluster-randomized at the level of the squadron to one of two conditions: the X-CoRe program or a control condition.


Eligibility Criteria:
Inclusion Criteria:

* Active Duty, stationed at JBMDL
* assigned to one of the 26 Air Force squadrons within the three Air Force Wings at JBMDL (87 Air Base Wing (ABW), 305 Air Mobility Wing (ABM), and 621 Contingency Response Wing (CRW))
* English speaking
* access to an electronic device with internet capabilities

Exclusion Criteria:

* being in service branches other than Air Force (e.g., Army or Navy)
* Airmen not ranked E1-E4 at JBMDL
Study to Evaluate the Safety and PK of UI018

This Study is to evaluate the safety and pharmacokinetics of a fixed dose combination formulation and co-administration.


Eligibility Criteria:
Inclusion Criteria:

* Healthy subjects between the ages of 19 and 45 years at screening
* Subjects whose body weight over 55 kg and ranged ± 20% of calculated Ideal body Weight(IBW) \[ IBW (kg) = (height(cm) - 100) x 0.9 \]
* Subjects able to read and understand a written informed consent, and willing to decide to participate in the study.
Intensive Education Versus Usual Education of Patients for Improving Guideline Directed Medical Therapy (GDMT) Prescription in Heart Failure With Reduced Ejection Fraction

The goal of this randomized clinical trial is to test the effect of patient education on extent of use of guideline directed medical treatment (GDMT) of heart failure with reduced ejection fraction. The main question that our study aims to answer is if patient education can improve the adherence to GDMT in heart failure with reduced ejection fraction. Participants will receive educations about GDMT benefits in 1,3 and 5 months after discharge from hospital.

This is a randomized clinical trial assessing the possible benefit of post-discharge education on the extent of guideline directed medical treatment for heart failure with reduced ejection fraction. Patients that are admitted to medical facilities of the Medstar health, Baltimore will be screened and if consented, they will all get an initial inhouse face to face education, and upon discharge, they will be randomized to the control group and intervention group. The latter will get more educations via phone-call sessions at 1, 3 and 5 months post discharge. The educational sessions will include educating the benefits of GDMT, reviewing the components of GDMT and their possible side effects, performing Medication reconciliation, Inquiries about reasons not getting the medications and encouraging adherence to clinic visits and requesting the treating providers for GDMT optimization. There will be no formal prescription or change of medication during the educational sessions. GDMT use will be assessed in all patients after 6 months according to GDMT score by the Heart Failure Collaboratory.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Heart Failure reduced Ejection Fraction (EF≤40%)
* Age \>18 years
* Able to consent for enrollment.
* Hospitalized at one of the Medstar facilities (Inpatient)

Exclusion Criteria:

* Pregnancy
* Patient with stage D heart failure candidates for advanced therapies or on home inotropes or receiving hospice service
* Patients with advanced organ failure (End stage cancer, Advanced dementia, MELD (Model for End-Stage Liver Disease) score \> 30, GFR (Glomerular filtration rate) \<25) in whom GDMT is Futile
* Patients with Heart failure Collaboratory Score (HFCS) of 9
Safety and Efficacy of TP10, a Complement Inhibitor, in Adult Women Undergoing Cardiopulmonary Bypass Surgery

The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side effects of complement inflammation as chest pain or heart attacks and be taken safely in women who undergo cardiopulmonary bypass surgery.

During cardiac surgery, a substance called "complement" is released by the body. This complement causes inflammation, which can lead to side effects such as chest pain, heart attacks, or heart failure. The purpose of this study is to determine if the study drug (TP10), which blocks complement release, can reduce such side events and be taken safely in women.

Eligibility Criteria:
Inclusion Criteria:

* Female
* To undergo high-risk cardiac surgery with cardiopulmonary bypass pump (CPB)
* CABG alone or with valve surgery

Exclusion Criteria:

* Acute myocardial infarction (heart attack) within a 3 days of entering the study
* Conditions that may interfere with interpretation of electrocardiogram data
* History of immune deficiency syndrome
* Planned supplemental cardiac surgery or other surgery
* Pregnancy or lactation
Risk Evaluation and Education for Alzheimer's Disease (REVEAL) IV

This study is intended to examine the impact of receiving a genetic risk assessment for Alzheimer's disease (AD) among individuals with Mild Cognitive Impairment (MCI).

Alzheimer's disease is a common condition affecting memory and thinking. Genes can sometimes be used to provide risk estimates for the eventual development of certain common diseases. Apolipoprotein E (APOE) is one gene which can provide information about a person's chances of developing Alzheimer's disease.

Some people with a diagnosis of Mild Cognitive Impairment (MCI) are curious to learn more about the chance of developing Alzheimer's disease. In the REVEAL IV Study, we are examining the psychological and behavioral impact of learning genetic risk information pertaining to the chance for an individual with MCI to progress to dementia of the Alzheimer's type within three years.

Participation in this study requires an initial phone call which will elicit some demographic information about the participant and his or her study partner. A first in-person visit to the research clinic will consist of an education session, the administration of knowledge and attitudinal surveys and some tests to assess memory and thinking skills. This visit will take approximately 2-3 hours. Participants with MCI will have their blood drawn for genetic testing. Participants will then be randomized to one of two groups. Those in the intervention arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age, the diagnosis of MCI and their own APOE gene test result. Those in the comparison arm will receive a three-year risk estimate for the chance of progressing to dementia of the Alzheimer's type based on age and the diagnosis of MCI, without the APOE gene test result. Participants randomized to the comparison arm will have the opportunity to learn their own APOE gene test result at the end of the study. Participants and their study partners will be followed for 6 months following disclosure of results with 1 additional clinic visit and 1 additional phone interviews.

Eligibility Criteria:
Inclusion Criteria:

* Individuals (55-90 years old) with Mild Cognitive Impairment (amnestic-MCI as defined by the Petersen criteria)
* Individuals who have a close friend, relative or spouse (18+) willing to be a study partner. Study partners attend each study visit with the participant and also complete surveys and interviews.

Exclusion Criteria:

* Individuals with current, untreated anxiety or depression
* Individuals who do not meet the criteria for amnestic-MCI
* Individuals who have the diagnosis of dementia or Alzheimer's disease
* Individuals not fluent in English
* Individuals who do not have a study partner
Study of Viral Respiratory Infections

Acute viral respiratory infections are a major public health problem, as they cause mortality especially in pediatric patients, over 65 and those with co-morbidities. The most frequently responsible viruses are: Influenza A and B, Respiratory Syncytial Virus, Adenovirus, Parainfluenza Virus, Metapneumovirus, Rhinovirus and SARS-CoV-2. By comparing clinical data and laboratory diagnosis among all categories of patients at greatest risk, it is possible to define the symptoms associated with the pathogen and establish which etiological agents could be able to cause clinical pictures characteristics of a given type of patient. The study will also provide information on the potential role that simultaneously detected pathogens may play in determining the severity of the clinical picture. In addition, the results will allow to deepen the changes in seasonality and spread of different respiratory viruses associated with the COVID-19 pandemic.

The aim of the study is:

1. Calculate the percentage of positive cases during 2018-2023.
2. Association between the viral pathogens detected individually or in packaging in respiratory material and: typology of symptomatology/clinical outcome; typology of clinical signs detectable with objective/instrumental examinations; degree of severity of clinical manifestation.
3. Reduction in the prescription of instrumental investigations (RX/ecoaddome) and reduction in the prescription of empirical antibiotic therapy with amoxicillin or amoxicillin and clavulanic acid in pediatric patients.

Eligibility Criteria:
Inclusion Criteria:

* Adult and pediatric patients, of any age, with clinical diagnosis of acute respiratory infections and with request for search of the main respiratory viruses (FLUA, FLUB, VRS, AdV, PIV, MPV, RV and SARS-CoV-2)
* Obtaining informed consent where possible.

Exclusion Criteria:

* None
Early Intervention in Preterm Infants: Short and Long Term Developmental Outcome After a Parental Training Program

Preterm infants, during their stay in the Neonatal Intensive Care Unit (NICU), face a period of stressful environment, which may negatively impact early brain development and subsequent neurobehavioral outcomes. This study aims to assess the effectiveness of training parents in reducing stressful experiences early in life and in enhancing brain development and long term developmental outcomes.

Very preterm birth is associated with motor, cognitive and behavioral problems.

Micro-structural brain abnormalities, even in the absence of focal lesions, have been documented by neuroimaging studies in preterm infants at term corrected age and later in childhood. These alterations in brain maturation occurring during the neonatal period may be implicated in long-term neurobehavioral disorders later experienced by preterm babies.

However, there is increasing evidence that also negative environmental factors (intensive care, excessive sensory stimulation, paucity of parental contact etc.) can affect later outcomes.

Potential benefits of early dyadic interaction and preterm baby massage in reducing the effects of the NICU stressor environment have been demonstrated. More recently, few studies have investigated visual function in preterm infants focusing on the potential role of early visual interaction to enhance attention and improve later neurodevelopment.

The role of early intervention strategies to improve neurodevelopment has been recently emphasized.

Early intervention programs based on the concept of "individualized care" have proved to be effective in promoting brain maturation and neurodevelopmental outcome. In this context, early interventions as the Mother Infant Transaction Program (MITP) and the Premie Start, both targeting parenting, have the greatest potential to have sustained effects on child development.

In addition, recent studies have shown that exposure to stressful events in the neonatal period can cause epigenetic modifications in children born preterm; in particular alteration of serotonergic tone was observed, associated with methylation of the serotonin transporter gene, which could be implicated in the etiology of behavioral disorders observed in these children. In animal models these epigenetic effects appear to be influenced by maternal care that can epigenetically modulate the offsprings' stress response.

Eligibility Criteria:
Inclusion Criteria:

* Gestational age between 25+0 and 29+6 weeks

Exclusion Criteria:

* major brain lesions as documented by cranial ultrasound (intraventricular hemorrhage \> 2 grade, cystic periventricular leukomalacia)
* neurosensorial deficits (retinopathy of prematurity \> stage 2)
* genetic syndromes and/or major congenital malformations
* major neonatal comorbidities

Mothers are selected according to the following inclusion criteria: age over 18 years, good comprehension of Italian language, no obvious cognitive impairments or psychiatric disorders, no drug addiction and no single-parent families.