cyrilzakka/clinical-trials huggingface dataset:
Standardized Rehabilitation for Intensive Care Unit (ICU) Patients With Acute Respiratory Failure

Acute Respiratory Failure (ARF) requiring mechanical ventilation affects 1.1 million of the 4.4 million people admitted to United States Intensive Care Units (ICU) every year. Patients with ARF have an average ICU and hospital length of stay (LOS) of 8 and 15 days, respectively, with median hospital costs greater than $30,000 United States. Patients with ARF experience deconditioning, muscle weakness, joint contractures, dyspnea, depression, and reduced health-related quality of life, all of which may contribute to prolonged hospitalization and increased costs. Mechanistically, it is understood that patients with ARF demonstrate acute inflammation which may contribute to the above cited problems. While the investigators' research and that of others has shown that rehabilitation therapy can increase functional outcomes while lowering biomarkers of inflammation in the frail aged and other clinical populations, it is not known whether such rehabilitation therapy can result in improved functional capacity and functional performance and reduce inflammation in ARF patients. There is previous evidence for the feasibility and safety of rehabilitation therapy in ARF patients. Therefore, the investigators propose a two-arm, randomized trial in 326 patients with ARF to compare Standardized Rehabilitation Therapy initiated in the ICU and administered throughout the hospitalization versus usual care (control). Standardized Rehabilitation Therapy will consist of: passive range of motion, physical therapy and progressive resistance exercise (strength training). The regimen will be administered 7 days/week by a Mobility Team consisting of a critical care nurse, physical therapist and nursing assistant.

The investigators will determine whether standardized rehabilitation therapy will reduce hospital LOS, improve functional capacity and performance, improve quality of life, reduce inflammation and reduce hospital costs as compared to usual care.

This study's primary objective is to determine whether standardized rehabilitation therapy will decrease hospital length of stay.

Hypothesis: Compared to usual care, standardized rehabilitation therapy will reduce hospital length of stay for patients with Acute Respiratory Failure.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Mechanically ventilated via an Endotracheal tube or Bipap
* Lung Injury

Exclusion Criteria:

* Previously enrolled in TARGET STUDY
* Inability to walk without assistance prior to acute ICU illness (use of a cane or walker not exclusion)
* Cognitive impairment prior to acute ICU illness (non-verbal)
* Acute stroke
* Body mass index (BMI) \> 50
* Neuromuscular disease that could impair weaning
* Hip fracture, unstable cervical spine or pathological fracture
* Mechanically ventilated \> 80 hours
* Current hospitalization or transferring hospital stay \> 7 days
* Ineligible cancer treatment within the last 6 month
* Moribund
* Do Not Resuscitate(DNR)/Do Not Intubate(DNI) on admission
* Other Research Study
CONFIDENCE-AI Financial Education for Caregivers (CONFIDENCE-AI)

The intervention being tested, CONFIDENCE-AI is a refined version of the original CONFIDENCE intervention made to reduce psychological financial strain and improve management of out-of-pocket care costs while increasing caregiver resourcefulness skills. Participants will be asked to participate in a 4-week intervention that includes participation in four, synchronous group-based Zoom sessions as well as between-session activities to apply learning. Participants will also receive tailored text message notifications from the NeuViCare AI-powered app via text and will be able to submit questions to the app to receive financial well-being information related to caregiving.


Eligibility Criteria:
Inclusion Criteria:

* Self-identified caregiver to a person living with probable Alzheimer's disease or related dementia
* Person living with dementia meets stage 4 to 6 criteria on Global Deterioration Scale according to the family caregiver
* Has been at least 6 months since the care recipient began to experience dementia symptoms
* Latino/Hispanic ethnicity.

Exclusion Criteria:

* Individuals who plan to place their family member in a nursing home in the next 3 months
* Unreliable access to internet, tablet or smart phone, and email
* Does not agree to participate in at least 3 of the 4 group sessions and/or register for the NeuViCare app
* Unable to read and speak in English or Spanish
Individual Optimal Positive End-expiratory Pressure During Robot-assisted Laparoscopic Radical Prostatectomy

During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Intraoperative ventilatory strategy to address these issues include intraoperative recruitment maneuver and positive end-expiratory pressure (PEEP). Recently, individualized optimal PEEP with minimal driving pressure or maximal respiratory compliance was reported to reduce respiratory complications after general anesthesia. A recent version of general anesthesia ventilator provides a stepwise procedure of determining optimal PEEP by calculating respiratory compliance. We investigated whether the application of individualized optimal PEEP could reduce the incidence of atelectasis and respiratory complications after robot-assisted laparoscopic radical prostatectomy compared to uniform PEEP.

During robot-assisted radical prostatectomy, pneumoperitoneum with Trendelenburg position is used. However, perioperative atelectasis and respiratory complications may occur with high incidence due to general anesthesia and carbon dioxide pneumoperitoneum. Intraoperative ventilatory strategy to address these issues include intraoperative recruitment maneuver and positive end-expiratory pressure (PEEP). Recently, individualized optimal PEEP with minimal driving pressure or maximal respiratory compliance was reported to reduce respiratory complications after general anesthesia. A recent version of general anesthesia ventilator provides a stepwise procedure of determining optimal PEEP by calculating respiratory compliance. We investigated whether the application of individualized optimal PEEP could reduce the incidence of atelectasis and respiratory complications after robot-assisted laparoscopic radical prostatectomy compared to uniform PEEP. We plan to determine the degree of immediate postoperative atelectasis by measuring the lung ultrasound score and compare the lung ultrasound score between groups.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing robot-assisted laparoscopic radical prostatectomy
* Patients receiving mechanical ventilation by Aisys Care Station anesthesia ventilator
* Patients who provided written informed consent to participate in this clinical trial

Exclusion Criteria:

* American Society of Anesthesiologists physical status classification class 3 or more
* Moderate or more obstructive or restrictive pulmonary disease
* Preoperative adult respiratory distress syndrome or previous history of adult respiratory distress syndrome
* history of heart failure, unstable angina, increased intracranial pressure
* history of pneumothorax or presence of bullae
Alteplase for Treatment of Empyema and Complicated Parapneumonic Effusion

The purpose of this study is to assess the benefit to patients with empyema or complicated parapneumonic effusion (CPE) using a daily versus twice daily Alteplase regimen of two different dose strategies compared with saline placebo.

This is a randomized, double-blind, placebo-controlled pilot study. Patients with empyema and complicated parapneumonic effusion who are felt to require fibrinolytic therapy will be considered for study enrollment. Enrolled patients will be randomized to one of five potential treatment arms (saline placebo, 4 mg once daily, 4 mg twice daily, 10 mg once daily, or 10 mg twice daily) in a double-blinded manner.

Eligibility Criteria:
Inclusion Criteria:

* Ability to provide written informed consent
* Age greater or equal to 18 yrs
* Presence of empyema or CPE

Exclusion Criteria:

* Active internal bleeding
* Pregnancy
* Prior enrollment in this study
* Platelet count less than 100,000/mm3
* Use of warfarin sodium if INR is greater than 1.7
* Use of heparin unless the PTT is less than 1.5 times baseline normal
* Known neurological disorders
* Current or pre-existing bleeding dyscrasia
* Known allergy to Alteplase
3T MRI to Predict TACE Response of HCC

This study is a prospective clinical study using DCE-MRI, DWI and MRS in 3T scanner to evaluate tumors in patients with unresectable HCC after TACE. A total of 100 subjects will be recruited. MRI will be performed before TACE (day 0), day 14, and day 28 to assess the tumor responses. After day 28, all subjects will receive standard clinical care and be follow-up for 1 year. The imaging parameters will be compared among each MRI and correlate with patients' outcome. The investigators hypothesis that it might be helpful to combine DCE-MRI, DWI, and MRS for assessment of tumor response after TACE and predict patients' prognosis.

Dynamic contrast-enhanced magnetic resonance imaging (DCE-MRI) is a non-invasive quantitative technique for assessing micro-vascular structure by tracking the pharmacokinetics of injected low-molecular weight contrast agents as they pass through the tumor vasculature. This modality is being increasingly used in many oncological studies to characterize tumor angiogenesis and invasiveness, and monitor the treatment response.

Diffusion-weighted imaging (DWI) enables qualitative and quantitative assessment of tissue diffusivity (apparent diffusion coefficient, ADC) without the use of gadolinium chelates. DWI has been suggested to be useful in monitoring the response of HCC after TACE because of earlier assessment of tumor necrosis with increasing ADC values.

MR spectroscopy facilitates the study of cellular metabolism and in vivo detection of abnormalities. A few studies of in vivo MR spectroscopy reported an increase in choline levels within tumors such as HCC and a reduction in the lipid-to-choline ratio after conventional TACE was performed for HCC.

Eligibility Criteria:
Inclusion Criteria:

1. Prior Informed Consent Form
2. Patients who had undergone surgery for the treatment of HCC are allowed.
3. At least one measurable tumor, according to RECIST version 1.1.
4. Age more than 20 years.
5. ECOG performance status 0 or 1.
6. Life expectancy more than 3 months.
7. Child-Pugh class A.
8. Unresectable, multinodular tumors
9. Confirmed Diagnosis of HCC
10. At least one uni-dimensional lesion measurable according to the Modified RECIST criteria by MRI
11. Adequate bone marrow, liver and renal function

Exclusion Criteria:

1. History of TACE
2. Diffuse infiltrative HCC or presence of main portal vein invasion or extrahepatic metastasis
3. Any contraindications for hepatic embolization procedures:, including hepatofugal blood flow, large intrahepatic or porto-systemic shunt, impaired clotting test, renal failure requiring hemo-or peritoneal dialysis
4. Any contraindication for MRI, including known contrast allergy, electronically operated implants or devices, and claustrophobia.
5. Other acute or chronic medical, psychiatric condition, or laboratory abnormality that may increase the risk associated with study participation and is inappropriate for this study by the judgment of the investigator
6. Known history of HIV infection
7. Concurrent primary extrahepatic cancer
8. Pregnant or breast-feeding subjects
Impact of the BOOST GAIT Program on Gait Recovery and Functional Mobility After Stroke

The overarching goal is to determine if the BOOST GAIT program can improve functional mobility in patients with stroke who are undergoing inpatient rehabilitation and have some walking function, through the application of augmented therapeutic exercises designed to achieve a normative gait pattern. The evaluation will be conducted using a combination of clinical scales and objective motion sensors that map walking quality and performance during activities of daily living, such as rising from a chair and standing.

It is acknowledged that this single-group pilot study, which aims to include 12 participants, is insufficiently powered to address the primary objective. A larger parallel-design study is required to definitively address this issue. To help design a larger study, the current objectives are: first, to have realistic expectations regarding recruitment and dropout rates; second, to identify potential barriers to therapy adherence and data collection that may impede the success of a larger study; third, assess the test-retest reliability of sensor-based motion capture of movement quality during walking and related tasks in hemiparetic stroke patients. For the latter objective, the sensor measurements at the end of the intervention will be repeated on two consecutive days.

In addition to their usual care, participants will undergo additional therapy over a four-week period, with sessions occurring five times per week for one hour as part of the BOOST GAIT program. The BOOST GAIT sessions will be conducted as group-based therapy with four patients and two physiotherapists present to oversee the performance of mobility-specific exercises, including sit-to-stand transfers, standing and stepping, and eventually walking. The rationale for this approach is that the combined effects of augmenting the amount of therapeutic exercises and specifically targeting motor control of the paretic leg will facilitate symmetry during tasks, which in turn will have carry-over effects on safe performance of walking and other mobility tasks.


Eligibility Criteria:
Inclusion Criteria:

* A first-ever unilateral stroke, infarction or bleeding
* Undergoing inpatient rehabilitation in the Jessa hospital, Herk-de-Stad
* Less than 3 months after stroke onset at the moment of inclusion
* 18 years of older
* Berg Balance Scale score 24 or higher (out of 56) at moment of inclusion
* Timed Up-and-Go score 14 s or higher at moment of inclusion
* Functional Ambulation Category 3 or higher at moment of inclusion
* Understanding the goals and procedures of this study and giving informed consent

Exclusion Criteria:

* Significant cognitive and/or speech impairments that markedly affect the comprehension and execution of instructions
Digital Remote Monitoring of Immune Checkpoint Inhibitor Therapy Induced Toxicity: A Feasibility Study of the Vigilant App (Vigilant-2)

This study is being done to better understand patient experiences with using a mobile application, known as Vigilant, to monitor symptoms as outpatients and to gather preliminary data on the potential clinical benefit to remote monitoring of adverse events.

PRIMARY OBJECTIVES:

I. Optimize the patient (Aim 1) experience of the VIGILANT app workflow. II. Gather preliminary data on the number of patients who develop Grade 3 + 4 immune-related adverse event (irAE) or require ER visit within 100 days of registration and treatment with IPI/NIVO.

OUTLINE: This is an observational study.

Patients undergo standard of care treatment with ipilimumab/nivolumab and answer questions and enter symptoms in the mobile Vigilant application. Patients wearing a compatible watch have their vital signs recorded at the same time symptoms are being entered. Based on the severity of symptoms, patients may be recommended to reach out to their healthcare team or to go to the emergency room. Additionally, patients complete a survey and may have their medical charts reviewed on study.

Eligibility Criteria:
Inclusion Criteria:

* Any skin cancer/melanoma patient starting dual \[ipilimumab/nivolumab (IPI/NIVO)\] immune checkpoint inhibitor (ICI) therapy

Exclusion Criteria:

* Does not meet inclusion criteria
Literacy Instruction Through Media for Everyone

The goal of this study is to determine whether an intervention to support caregivers in engaging with their children while using educational media together can improve children's early literacy skills, compared to an aligned shared book reading intervention and to no intervention. Given that early literacy skills predict children's later academic learning, this home intervention, which aims to shape the communication patterns surrounding a common, family-friendly activity, has the potential to positively influence the trajectory of low income children's academic success. We propose that a media based activity will reduce barriers and increase adherence therefore increasing literacy skills over time.

The proposed study draws upon an implementation science framework (Nilsen, 2015) to determine the extent to which a media-based caregiver-led intervention improves caregiver adherence and in turn children's early literacy development relative to a shared reading intervention. Caregiver-implemented shared reading interventions represent the 'current standard practice' for addressing early literacy needs, yet many caregivers cannot implement this practice with adequate adherence. This is particularly true for low-socioeconomic status families, in which shared reading may not be a conventional activity and barriers inhibit its use. We propose-and test-that a media-based intervention reduces barriers to intervention implementation and increases social validity, leading to higher levels of adherence and, via mediation, enhanced child literacy outcomes. To establish this causal chain, we implement a media-based early literacy intervention, compare it to a highly aligned shared reading intervention, and measure (1) social validity of the intervention to test whether use of media circumvents barriers, (2) caregiver adherence (i.e., frequency and dosage), and (3) child early literacy skills gains immediately and over time. As the first causally interpretable study to compare media and shared reading as caregiver-led interventions, the proposed project will identify strategies to improve adherence in home-based interventions and inform development of interventions to improve school readiness among low-SES children.

Eligibility Criteria:
Inclusion Criteria:

* between 42 and 57 months at enrollment
* minimally verbal in English
* caregiver sufficiently proficient in English
* does not have severe intellectual disability

Exclusion Criteria:

* under 42 months
* over 57 months at enrollment
* severe intellectual disability
* not proficient in English
Evaluation of Complication Rates Using Filter vs. Centrifuge and Heparin vs. Citrate Anticoagulation

Despite its growing use across the world, and similar efficacy, filter-based therapeutic plasma exchange (TPE) continues to be used less often that centrifuge-based TPE. One of the reasons is that the patient and circuit complications of centrifuge-based TPE are familiar to the clinical team. There is little data on the patient and circuit complications of filter-based TPE (using the Prismaflex). Furthermore, there is a reluctance to use filter-based TPE because historically, most TPE programs have used citrate-regional anticoagulation, and there is a large gap in knowledge in the use of citrate regional anti-coagulation when using filter-based TPE.

Studies that evaluate differences between filter-based vs. centrifuge based TPE are lacking. Heparin-based TPE is the most commonly used method of anti-coagulation when performing filter-based TPE. Citrate anticoagulation is FDA approved for use during TPE and its use is the gold-standard anti-coagulant method for TPE. However, citrate has not been studied rigorously in patients who are on filtration-based TPE on Prismaflex.

Providing citrate-based anticoagulation during TPE is challenging for several reasons. First, because calcium will bind to albumin, one must provide additional albumin in some way to prevent hypocalcemia. Second, when the replacement fluid is fresh frozen plasma (FFP), the clinician must account for a very large dose of citrate (which can be 3 times higher than the dose used to anti-coagulate whole blood) that is present in the FFP. Based on these principles, with clinical observations and experience using citrate-based continuous renal replacement therapy, this hospital developed a clinical protocol for use during filter-based TPE. This protocol has been in use since 2012 in the Renal Care Center at the Children's of Alabama.

As the use of filter-based TPE continue to rise, clinicians need evidence-based data to help them care for their patients. Although there are a few reports on the complication rates during centrifuge TPE, known, there are no published reports on the complication rate during filter-based TPE. A comparison of the complications rate between filter-based TPE and centrifuge TPE will help providers recognize the safety of filter-based TPE. There are no known regional citrate anticoagulation protocols for patients receiving filter-based TPE using Prismaflex. As the use of filter-based TPE continues to rise, there is a great need to fill this important knowledge gap. As more patients are cared in critical care arena, more clinicians will need evidence-based protocols for regional citrate anti-coagulation. This study will fill important gaps in knowledge that will improve the ability of clinical teams to provide filter-based TPE using Prismaflex.

Eligibility Criteria:
Inclusion Criteria:

* Patients who received therapeutic plasma exchange at Children's of Alabama between 2012 and 2019

Exclusion Criteria:

* Patients that received TPE with concomitant extra-corporeal membrane oxygenation
The Objective Assessment and Characteristics of Dry Nose From Clinical Perspective

In the present study, we propose objective diagnostic criteria for dry nose (DN) and investigate its characteristics. Questionnaires were completed by each participant during recruitment to record demographic data. DN test strips were used to evaluate the severity of DN at five time points and allergic status was assessed based on serum sIgE levels. Nasal secretions were collected and vasomotor rhinitis was diagnosed using the cold dry air test. The diagnosis of allergic rhinitis (AR) was based on the criteria of the Allergic Rhinitis and its Impact on Asthma consensus statement. Data are expressed as median and interquartile range, unless otherwise specified. Statistical significance was set at P \< 0.05. The reference range (RR) of the 5th, 10th, 25th, 50th, 75th, 90th, and 95th percentiles were determined for each test strip length at each time point. This study aimed to investigate the characteristics of and propose objective diagnostic criteria for DN.


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of dry nose patients.

Exclusion Criteria:

* chronic rhinosinusitis and/or nasal polyposis, allergic fungal rhinosinusitis, immunological disease, tumor patients, pregnant women.