cyrilzakka/clinical-trials huggingface dataset:
Ventilatory Variables in Subjects With Acute Respiratory Distress Syndrome Due to COVID-19

Research question: Are the ventilatory variables related to mechanical power associated with the outcome of subjects who received mechanical ventilation (MV) for Acute Respiratory Distress Syndrome (ARDS) secondary to pneumonia (NMN) due to COVID-19?

Primary Objective:

- To evaluate the association between the ventilatory variables of mechanical power and the outcome of the subjects in terms of mortality, days on MV and days free of MV at 28 days (both in survivors).

Secondary Objectives:

- Evaluate the association of demographic and gas exchange variables with the outcome of the subjects.

METHODOLOGY

Study design: retrospective and observational, analytical.

Operational definition of variables

Ventilatory variables:

* Global mechanical power: 0.098 × Tidal Volume × Respiratory Rate × (Peak Pressure - ½ Distension Pressure)
* Dynamic elastic mechanical power: 0.098 × Tidal Volume × Respiratory Rate × 0.5 × Distension Pressure
* Static elastic mechanical power: 0.098 × Tidal Volume × Respiratory Rate × PEEP
* Resistive mechanical power: 0.098 × Tidal Volume × Respiratory Rate × (Peak Pressure - Plateau Pressure)
* Cyclic Strain: DP x 4 + Respiratory Rate.
* Driving Pressure adjusted to predicted body weight: Driving Pressure / Tidal Volume (in ml / kg of predicted weight).

Demographic Variables:

* Age: in years.
* Sex: female / male.
* ARDS Classification:

  * Mild (PaO2 / FIO2 ≤ 300 mm Hg and \> 200 mm Hg)
  * Moderate (PaO2 / FIO2 ≤ 200 mm Hg and \> 100 mm Hg)
  * Severe (PaO2 / FIO2 ≤ 100 mm Hg)
* Body mass index: weight in kilograms divided by height in meters squared.

Gas Exchange Variables:

* Ventilatory quotient: (Respiratory Rate x Tidal Volume x PCO2) / (Predicted Weight x 100 ml x 37.5)
* Pa/FiO2: Arterial oxygen pressure/ Fraction of inspired oxygen Outcome Variables
* Mortality
* MV-free days at 28 days
* MV days Population and scope of study: Subjects registered in the ICU 2 database of the Francisco Santojanni Donation Hospital of the Autonomous City of Buenos Aires, who have received MV for ARDS with a confirmed diagnosis of COVID-19 pneumonia by polymerase chain reaction.

Study period: Data from subjects admitted from April 2020 to August 2021 will be analyzed.

Results analysis plan: A descriptive analysis of the clinical variables will be performed using the mean and standard deviation (SD), if the distribution is normal, or the median and interquartile range (IQR) otherwise.

Categorical variables will be presented as absolute number of presentation and percentage.

A value of p\<0.05 will be considered as statistically significant.

SPSS software will be used for data analysis.

Eligibility Criteria:
Inclusion Criteria:

* Confirmed diagnosis of pneumonia due to COVID-19.
* Need of mechanical ventilation in intensive care unit.

Exclusion Criteria:

* Patients with data loses
Enhancing Information Management for Young Adults After Genetic Cancer Risk Testing

This research is being done to develop the electronic platform Nest for young adults (ages 18-39) who have had prior cancer genetic testing. The platform will give patients and their clinicians access to continuously updated information about both pathogenic variants and variants of uncertain significance (VUS).

The name of the intervention used in this research study is:

Nest portal (electronic platform for patients and clinicians)

The goal of the electronic platform Nest is to help patients understand and manage genetic test results and recommended care and to help clinicians with access to results and recommendations, facilitating orders, and documentation. The portal has two parts, one for participants and one for clinicians.

For the first phase of the study, participants will give their feedback on the Nest portal's content and processes that will guide refinement of the portal. The Pilot phase will test the feasibility and acceptability of the intervention.

The research study procedures include a baseline survey, using the portal after receiving a brief orientation from the study team, a follow-up survey, and then a 30-minute interview.

Participants will be in this research study for up to 2 hours.

It is expected that about 40 people will take part in this research study.

The electronic platform is being developed by Nest Genomics.

Eligibility Criteria:
Inclusion Criteria AIM 1:

* YA Patients:

  * Ages 18-39 years, inclusive.
  * Has had previous cancer genetic testing, with a finding of a pathogenic variant or VUS; patient has previously received results from the clinical team.
  * English-speaking and -reading.
  * Receiving care at DFCI.
  * Not undergoing active cancer therapy at the time of approach.
* Clinicians:

  * Cancer risk physicians (oncologists, gastroenterologists, geneticists), oncologists, nurse practitioners, physician assistants, or genetic counselors.
  * English-speaking and -reading.
  * Cares for YAs aged 18-39 with cancer risk syndromes.

Inclusion Criteria AIM 2:

* YA Patients:

  * Ages 18-39 years, inclusive.
  * Has had previous cancer genetic testing, with a finding of a pathogenic variant or VUS; patient has previously received results from the clinical team.
  * English-speaking and -reading.
  * Receiving care at Dana-Farber Cancer Institute.
  * Did not participate in a stakeholder interview (Aim 1).
  * Not undergoing active cancer therapy at the time of approach.
* Clinicians:

  * Oncologists, nurse practitioners, cancer risk physicians, or genetic counselors.
  * English-speaking and -reading.
  * Caring for a participating YA.
Innovative Support for Patients with SARS-COV2 Infections (COVID-19) Registry (INSPIRE)

The Innovative Support for Patients with SARS COV-2 Infections Registry (INSPIRE) study is a CDC-funded COVID-19 project to understand the long-term health outcomes in recently tested adults, both negative and positive, who have suspected COVID symptoms at the time of their test. Participants will complete short online surveys every 3 months for 18 months, share information about their health using a secure web-based platform, and are compensated for their time.

This study will use a digital platform to longitudinally track comprehensive information including patient self-report as well as data that describe the process and outcome of care in the electronic medical record (EMR) of a large representative sample of patients under investigation for SARSCOV2. The objective is to generate knowledge rapidly using digital tools and collaborative sciences to produce real-time data, analysis, and reporting compared to more traditional approaches. An additional goal is to promote an open science approach whereby scientists, with proper approvals and in line with the permissions granted by the participants, have the opportunity to work with data in ways that protect individual privacy but promote rapid dissemination and implementation of knowledge.

Eligibility Criteria:
INCLUSION CRITERIA

1. Fluent in English or Spanish;
2. Age 18 and over;
3. Self-reported symptoms suggestive of acute SARSCOV2 infection;
4. Under investigation for SARSCOV2 (defined as a patient who has received any screening or diagnostic test used to detect the presence of COVID19 including any FDA approved or authorized molecular or antigen-based assay) within the last 42 days.

EXCLUSION CRITERIA

1. Unable to provide informed consent;
2. Study team unable to confirm result of diagnostic test for SARSCOV2;
3. Does not have access to a hand-held device or computer that would allow for digital participation in the study;
4. Individuals who are prisoners while participating in the study.
Work Design Interventions for Heat Resilience

The goal of this project is to compare different ways to schedule a workday to see if older workers should follow a specific work protocol to reduce strain on the heart and muscles.

Participants will come to the lab a total of six times. During four of the visits participants will complete a box lifting task, simulating loading and unloading a delivery truck. This will take place in a hot and humid room to simulate being outdoors during the summer.


Eligibility Criteria:
Inclusion Criteria:

* 40-65 years old

Exclusion Criteria:

* Musculoskeletal injury that would impact the ability to safely perform the trial
* Cardiovascular, metabolic, respiratory, renal, or neurologic conditions that would impact the ability to safely perform the trial
Intranasal Insulin for Posttraumatic Stress Disorder

To evaluate if intranasal insulin is effective in reducing PTSD symptoms.

The current proposal aims to study the pharmacotherapeutic effects of intranasal insulin on PTSD symptoms and inhibition of amygdala hyperactivation in subjects with PTSD.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, 21-65 years old
* Current PTSD
* Able to provide written informed consent

Exclusion Criteria:

* Unstable medical condition, clinically determined by a physician
* Diabetes requiring insulin or oral hypoglycemic agents
* Moderate-severe traumatic brain injury
* Current psychotic disorder, bipolar disorder, cognitive disorder in the past 12 months
* Current substance use disorders (except alcohol, tobacco, or cannabis) in the past 3 months
* Changes in doses of psychotropic medications in the past 4 weeks
* Initiation of individual therapy or counseling in the past 4 weeks
* Imminent suicidal or homicidal risk
* Contraindication to Insulin
* History of claustrophobia
* Presence of cardiac pacemaker or other electronic device or ferromagnetic metal foreign bodies in vulnerable positions as assessed by a standard pre-MRI safety screening questionnaire
Dakin's Solution in Preventing Radiation Dermatitis in Patients With Breast Cancer Undergoing Radiation Therapy

This pilot clinical trial studies Dakin's solution in preventing radiation dermatitis in patients with breast cancer undergoing radiation therapy. Radiation dermatitis is a skin condition in which the affected skin becomes painful, red, itchy, and blistered. Dakin's solution may help reduce dermatitis caused by radiation therapy.

PRIMARY OBJECTIVES:

I. To determine the percent change in women who experience grade 3 or 4 radiation dermatitis as defined by the Stanford Radiation Dermatitis Scoring System during radiation treatment for breast cancer compared to historical experience using standard skin care.

SECONDARY OBJECTIVES:

I. To assess the feasibility of daily application of the hypochlorite solution (Dakin's solution), and to assess levels of pain during radiotherapy treatment.

OUTLINE:

Patients apply Dakin's solution topically daily over 10 minutes within 60 minutes of radiation therapy for up to 6 weeks.

After completion of study treatment, patients are followed up at 4-6 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Women with breast cancer who plan to undergo radiation therapy to the breast or chest wall
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Women with scleroderma or discoid lupus
* Women with inflammatory breast cancer as evidenced by clinical assessment
* Women with breast cancer involving the skin
* Women who have undergone prior radiotherapy to the chest wall and/or breast
Efficacy and Safety of Remote Ischemic Conditioning in the Treatment of Essential Hypertension (RICBP-EH)

The purpose of this study is to determine the efficacy and safety of remote ischemic conditioning in the treatment of essential hypertension.

Current studies have shown that remote ischemic conditioning can improve vascular endothelial function, inhibit sympathetic nervous system activity and regulate immune and inflammatory reactions. Thus it may exert anti-hypertensive effects through multiple mechanisms. The purpose of this study is to investigate the efficacy and safety of remote ischemic conditioning on blood pressure patients with essential hypertension.

Eligibility Criteria:
Inclusion Criteria:

1. Age≥18 years, regardless of sex;
2. Patients with systolic blood pressure ≥140mmHg with or without taking oral antihypertensive drugs
3. Signed and dated informed consent is obtained

Exclusion Criteria:

1. Secondary hypertension;
2. Clinical blood pressure ≥ 180/110 mmHg or 24-hour mean arterial pressure ≥ 170/100 mmHg;
3. Severe organ dysfunction or failure;
4. Severe hematologic disorders or significant coagulation abnormalities;
5. History of atrial fibrillation or myocardial infarction within 6 months;
6. Individuals who had contraindication of remote ischemic conditioning, such as severe soft tissue injury, fracture or vascular injury in the upper limb, acute or subacute venous thrombosis, arterial occlusive disease, subclavian steal syndrome, etc;
7. Individuals who will or have received anticoagulant therapy with drugs such as dabigatran, rivaroxaban, warfarin, etc; ;
8. Pregnant or lactating women;
9. Those who are participating in other clinical research or has participated in other clinical research or has participated in this study within 3 months prior to enrollment;
10. Other conditions that the researchers think are not suitable for the project.
Efficacy and Safety of Ikervis Under Controlled Environmental Conditions Environment

The proposed study is a prospective, open-label, unicentric, phase IV clinical trial.

This study is design to find new efficacy biomarkers for IKERVIS® (1mg/mL ciclosporin) eye drops after 1 and 3 month after initiation of therapy. Additionally, this study intends to investigate whether IKERVIS® will help patients to better overcome situations of desiccating stress by exposing them to an adverse controlled environment (ACE) and analyzing both clinical and molecular parameters.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years.
* Diagnosis of DED with Severe Keratitis who have not improved despite regular use of tear substitutes by an ophthalmologist, at least 2 months previously.
* Not stable (as defined by the two items below) under at least 2 months of constant and regular use of artificial tears (at least 4 drops a day)
* Fluorescein corneal staining ≥ 2 (Oxford scale) in both eyes.
* DEQ-5 \> 6 points
* Use of at least 4 times daily of an ocular artificial tears.
* Any concomitant medication that may affect DED, ocular surface condition or vision, must have a start date at least 3 months prior to baseline and dosage is not expected to change during the study.
* Best corrected visual acuity (BCVA) of at least 0.1 logMar at 6 meters with each eye.
* Signature of written informed consent form and data protection form.

Exclusion Criteria:

* Known allergy or sensitivity to the study product(s) or its components.
* Any ocular pathology other than DED.
* History of severe ocular inflammation other than that due to DED or infection in the 6 previous months to the study inclusion.
* Any ocular surgery or trauma that may affect corneal sensitivity and/or normal tear distribution in the 6 previous months or any ocular or systemic surgery or procedure planned during the study duration that may affect the study as assessed by principal investigator.
* History of refractive surgery in the previous 18 months.
* Contact lens use in the ONE previous month to study inclusion and during the duration of the study.
* Use of any ocular topical medication for pathologies other than DED.
* Use of any other ocular topical medication for DED other than artificial tears during the last ONE (steroids) or THREE months (ciclosporine, tacrolimus) .
* Any uncontrolled severe systemic disease that may affect the eye (except for Sjögren's syndrome)
* The start date of any systemic medication that may affect DED, ocular surface condition or vision is \< 3 months prior to baseline or a change in dosage is anticipated during the study.
* Occlusion of the lacrimal puncta either surgically or with plugs within one month prior to study, or anticipated use of the same during the study.
* Pregnancy or breastfeeding.
* Current enrolments in an investigational drug or device study or participation in such a study within 30 day of entry into this study at baseline.
Evaluate the Safety and Anti-Hypertensive Efficacy of Hyzaar(R) In Patients With Mild To Moderate Essential Hypertension (0954A-323)

Evaluate the safety and anti-hypertensive efficacy of hyzaar(R) in patients with mild to moderate essential hypertension.


Eligibility Criteria:
Inclusion Criteria:

* Patient is either receiving high blood pressure monotherapy or no treatment
* Patient will have reached the legal age by the time enter the study
* Patients diagnosed with mild to moderate essential high blood pressure or high blood pressure with other conditions such as diabetes or cardiovascular diseases and are taking high blood pressure medication (exclude diuretic), but did not meet treatment goal

Exclusion Criteria:

* Patient with high levels of uric acid in the blood who has received medications for uric acid in the urine within 3 months prior to enrollment
* Patients who are hypersensitive to any component of the study medication
* Patients who are hypersensitive to other sulfonamide-derived drugs
* Patients with anuria (hyzaar(R) is not recommended for patients with hepatic impairment or severe renal impairment, creatinine clearance \</= 30 ml/min)
* Unstable diabetes (hba1c \> 8%), or a change in diabetes medication during study treatment. patients with stable diabetes may enter the study.
Hydroxychloroquine, Oseltamivir and Azithromycin for the Treatment of COVID-19 Infection: An RCT

To evaluate the effectiveness of Hydroxychloroquine Sulfate (200 mg orally 8hr thrice a day for 5 days) vs oseltamivir (75 mg orally twice a day for 5 days) vs Azithromycin (500 mg orally daily on day 1, followed by 250 mg orally twice a day on days 2-5) alone and in combination (in all seven groups), in clearing the coronavirus nucleic acid from throat and nasal swab and in bringing about clinical improvement on day 7 of follow-up (primary outcomes).

A scientific taskforce notified by the Ministry of Science and Technology of the Government of Pakistan will oversee a comprehensive cohort study. Within this cohort, a multicenter, adaptive, randomized controlled trial will evaluate, among eligible SARS-Cov-2 (COVID-19) infected patients receiving standard supportive care who consent to randomization following a new diagnosis in Pakistan, if Hydroxychloroquine Sulfate alone (control intervention) vs a series of alternatives (comparator interventions) including Oseltamivir and Azithromycin alone and in combination with Hydroxychloroquine Sulfate is effective in clearing the coronavirus and improving the clinical course of the disease. Those not consenting to randomization will be followed up for outcomes of SARS-Cov-2 infection with supportive care only. Findings of this study are expected to inform clinical care and public health protocols and policies for management of SARS-Cov-2.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed SARS-CoV-2 (COVID-19) infection by a positive test result
2. Either gender
3. Symptomatic for example fever, dry Cough, difficulty to breathe

Exclusion Criteria:

1. Confirmed absence of SARS-CoV-2 (COVID-19) infection by a negative test result
2. Have chronic conditions such as heart disease, liver and kidney failure
3. Pregnant or currently lactating
4. Immunocompromise and/or systemic disease(s)
5. On other antiviral drugs
6. History of allergy to any of the drugs to be administered in this study
Efficacy and Safety Study of Apremilast to Treat Active Psoriatic Arthritis

The purpose of this study is to determine whether apremilast is safe and effective in the treatment of patients with psoriatic arthritis, specifically in improving signs and symptoms of psoriatic arthritis (tender and swollen joints, pain, physical function) in treated patients.

Psoriatic arthritis (PsA) is an inflammatory arthritis that occurs in 6-39% of psoriasis patients. The immunopathogenesis of PsA, which mirrors but is not identical to that seen in psoriatic plaques, reflects a complex interaction among resident dendritic, fibroblastic and endothelial cells, and inflammatory cells attracted to the synovium by cytokines and chemokines. Apremilast (CC-10004) is a novel oral agent that modulates multiple inflammatory pathways through targeted phosphodiesterase type 4 (PDE4) enzyme inhibition. Therefore, apremilast has the potential to be effective in the treatment of PsA.

Eligibility Criteria:
Inclusion Criteria:

* Males or females, aged ≥ 18 years at time of consent.
* Have a diagnosis of Psoriatic Arthritis (PSA, by any criteria) of ≥ 6 months duration.
* Meet the Classification Criteria for Psoriatic Arthritis (CASPAR) at time of screening.
* Must have been inadequately treated by disease-modifying antirheumatic drugs (DMARDs)
* May not have axial involvement alone
* Concurrent treatment allowed with methotrexate, leflunomide, or sulfasalazine
* Have ≥ 3 swollen AND ≥ 3 tender joints.
* Males \& Females must use contraception
* Stable dose of nonsteroidal anti-inflammatory drugs (NSAIDs), narcotics and low dose oral corticosteroids allowed.

Exclusion Criteria:

* Pregnant or breast feeding.
* History of allergy to any component of the investigational product.
* Hepatitis B surface antigen and/or Hepatitis C antibody positive at screening.
* Therapeutic failure on \> 3 agents for PsA or \> 1 biologic tumor necrosis factor (TNF) blocker
Eliminating HCV in Rural South Carolina Utilizing NP Led Mobile Clinics and Virtual Care Coordination

Up to 150 individuals with current hepatitis C (HCV) will be recruited from mobile health clinics in rural South Carolina - sites will be selected based on HCV prevalence rates and lack of current HCV screening/treatment resources. NPs will provide HCV care through mobile health units. Participants will be randomized (1:1) to either mobile health clinic treatment as usual or virtual care coordination. Virtual care coordination designed to move people along HCV care cascade will be conducted by the Emocha smartphone platform - an adaptable platform designed by emocha to link patients to care. Using quantitative methods, associations between psychosocial factors such as homelessness, mental illness, provider mistrust, poor social support, high levels of shame and stigma with HCV outcomes including SVR will be examined. Investigators hypothesize that SVR rate among the HCV-infected individuals treated (and with follow-up SVR determination) will be 90% with the Clopper-Pearson 95% CI having a width of 13%.


Eligibility Criteria:
Inclusion Criteria:

* Not previously treated with HCV direct-acting antiviral medications OR treatment-experienced and eligible for treatment with sofosbuvir/velpatasvir
* Age 18+
* Willing to be randomized to either emocha versus TAU arms
* Able to provide informed consent

Exclusion Criteria:

* Pregnant or breastfeeding