cyrilzakka/clinical-trials huggingface dataset:
Deep Learning Magnetic Resonance Imaging Radiomics for Diagnostic Value of Hepatic Tumors in Infants

Hepatic tumors in the perinatal period are associated with significant morbidity and mortality in affected patients. The conventional diagnostic tool, such as alpha-fetoprotein (AFP) shows limited value in diagnosis of infantile hepatic tumors. This retrospective-prospective study is aimed to evaluate the diagnostic efficiency of the deep learning system through analysis of magnetic resonance imaging (MRI) images before initial treatment.

Hepatic tumors seldom occur in the perinatal period. They comprise approximately 5% of the total neoplasms of various types occurring in the fetus and neonate. Infantile hemangioendothelioma is the leading primary hepatic tumor followed by hepatoblastoma. It should be mentioned that alpha-fetoprotein (AFP) is highly elevated during the first several months after birth even in normal infants, thus the diagnostic value of AFP is limited for infantile patients with hepatic tumors. This study is a retrospective-prospective design by West China Hospital, Sichuan University, including clinical data and radiological images. A retrospective database was enrolled for patients with definite histological diagnosis and available magnetic resonance imaging (MRI) images from June 2010 and December 2020. The investigators have constructed a deep learning radiomics diagnostic model on this retrospective cohort and validated it internally. A prospective cohort would recruit infantile patients diagnosed as liver tumor since January 2021. The proposed deep learning model would also be validated in this prospective cohort externally. The established model would be able to assist diagnosis for hepatic tumor in infants.

Eligibility Criteria:
Inclusion Criteria:

* Age between newborn and 12 months
* Receiving no treatment before diagnosis
* With written informed consent

Exclusion Criteria:

* Clinical data missing
* Unavailable MRI images
* Without written informed consent
DEtermining Accuracy and TrEnding CharacTerization of AF

The objective of this study is to assess the atrial fibrillation (AF) episode detection when using the SJM(St. Jude Medical) Confirm ICM (Implantable Cardiac Monitor).


Eligibility Criteria:
Inclusion Criteria:

* The subject has been implanted with a SJM Confirm ICM, DM2102.
* The subject has or is suspected to have paroxysmal AF.
* The subject is ≥ 18 years of age.
* The subject is willing and able to provide written Informed Consent (prior to any investigational related procedure).

Exclusion Criteria:

* The subject has persistent (\>7 days and ≤1 year or requiring cardioversion), longstanding persistent (continuous AF \>1 year) or permanent AF (not attempting to restore sinus rhythm).
* The subject has AF of reversible etiology (e.g. electrolyte imbalance, thyroid disease).
* The subject has a contraindication to Holter recording.
* The subject has already received an active implantable medical device other than the SJM Confirm ICM, DM2102.
* The subject is unable to comply with the follow up schedule.
* The subject is participating in another investigational device or drug investigation.
* The subject is pregnant or is planning to become pregnant during the duration of the investigation.
Conventional Low Flow Oxygenation Versus High Flow Nasal Cannula in Hypercapnic Respiratory Failure

Current evidence suggests a mechanistic and physiological rationale for the use of high flow nasal cannula (HFNC) in acute respiratory hypoxemic failure (AHRF) based on physiological studies in airway models, healthy volunteers and patients with Chronic Obstructive Respiratory Disease (COPD). This is supported by observational studies in patients with AHRF with reductions in a range of respiratory and other physiological parameters. Observational studies also suggest similar intubation rates and lower failure rates with HFNC when compared to non-invasive ventilation (NIV) with improved patient acceptance and tolerance for HFNC.

The role of HFNC is less clear in acute hypercapnic respiratory failure. Although non-invasive ventilation is the recommended treatment, it is associated with discomfort, and a significant proportion (up to 25% in some reports) cannot tolerate non-invasive ventilation. Observational reports and limited data from randomized controlled trials suggests that HFNC is effective in treating patients with hypercapnic respiratory failure.

We designed this trial to assess whether early application of HFNC in patients with non-severe hypercapnic respiratory failure can correct barometric abnormalities, and prevent progression to non-invasive ventilation or tracheal intubation and mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients \> 18 years of age
* Acute Hypercapnic respiratory failure with pH \< 7.35 and pCO2 \> 45 mmHg

Exclusion Criteria:

* Pregnant or Breast-Feeding
* Patients who cannot read and understand French or English
* Hypercapnia secondary to a drug toxicity or non-pulmonary aetiology
* Hypercapnia secondary to exacerbation of asthma
* Contraindication to NIV
* Contraindication to HFNC
* Not for escalation to NIV based on a ceiling of care
* pH \< 7.15
* GCS 8 or less
* Shock defined as systolic \< 90 mmHg or a reduction by 20mmHg from usual systolic BP despite volume resuscitation
* Respiratory or cardio-respiratory arrest
* Any other indication that requires immediate invasive/non-invasive mechanical ventilation
Robot-assisted Training

The goal of this clinical trial is to evaluate the long-term effects of isokinetic rehabilitation training in patients with spinal muscular atrophy (SMA). The main question it aims to answer is:

• Does isokinetic training at fixed angular velocity improve muscle strength and functional recovery in SMA patients?

Participants will:

* Perform isokinetic training using a portable device with a fixed angular velocity.
* Undergo long-term rehabilitation sessions, with assessments of muscle strength and overall functional improvement over the training period.


Eligibility Criteria:
Inclusion Criteria:

1. Age range: 5-30 years old.
2. Patients with spinal muscular atrophy (SMA).
3. The subject or guardian is willing and able to sign an informed consent form.

Exclusion Criteria:

1. Simultaneously suffering from other major diseases or illnesses.
2. Special populations such as pregnant and lactating women.
3. Refusing to sign the informed consent form or being unable to complete the entire research process.
4. Currently infected with human immunodeficiency virus (HIV), infectious hepatitis B or C, or corresponding medical history.
5. Simultaneously suffering from medical problems, including but not limited to the following:

Uncontrolled hypertension (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥ 95mmHg), congestive heart failure (New York Heart Association status classification III or IV).

The participant is mentally incapable or unable to understand the requirements for participating in the study.
Falls Of Unknown Origin (FUKNO) - Are Morbidity and Mortality Predictable in Patients Presenting With Falls?

It is the investigators goal to identify the prevalence of underlying diseases, make disposition more rational, and establish risk stratification tools in elderly patients presenting with falls. Additionally, the outcome of standard care (clinical assessment only for disposition) will be compared with a new approach combining the standard of care with biomarker assisted disposition of elderly patients presenting with falls. Therefore the investigators are looking at the following points.

Emergency department work-up

1. Prevalence of underlying disease
2. Developing algorithms for initial assessment Disposition

a. Establishing biomarker enhanced disposition planning by using risk-stratification tools b. Comparing geriatric emergency assessment to standardized disposition planning


Eligibility Criteria:
Inclusion Criteria:

* All fall patients aged 65 years and older who presented to the emergency department giving written informed consent

Exclusion Criteria:

* Patients below 65 years
* Non-fall patients above 65 years
* or lack of informed consent by patients or proxies
Open-Label Extension of Voxelotor

Open-label extension study of voxelotor for participants with Sickle Cell Disease who have participated in voxelotor clinical trials.

Open-label extension (OLE) study of voxelotor for participants with Sickle Cell Disease who have participated in voxelotor clinical trials. Up to approximately 600 participants with sickle cell disease (SCD), will be enrolled at approximately 70 clinical sites globally. All participants will receive voxelotor once daily, administered orally as tablets, dispersible tablets, or powder for oral suspension formulation. The objective of this OLE is to assess the safety of, and SCD-related complications of, long-term treatment with voxelotor, in participants who have completed treatment in a Global Blood Therapeutics (GBT)-sponsored voxelotor clinical study.

Eligibility Criteria:
Inclusion Criteria:

* Male or female participant with SCD, who participated and received study drug in a GBT-sponsored voxelotor clinical study.

Note: Participants who discontinued study drug due to an AE, but who remained on study, may be eligible for treatment in this study provided the AE does not pose a risk for treatment with voxelotor.

Note: Participants who discontinued Study GBT440-032 as the result of an abnormal transcranial Doppler (TCD) flow velocity assessment (≥ 200 cm/sec) are eligible for treatment in this study.

- Participant has provided written consent/assent (for pediatric participants, both the consent of the participant's legal representative or legal guardian and the participant's assent \[where applicable\] must be obtained).

Exclusion Criteria:

* Female participant who is breastfeeding or pregnant
* Participant withdrew consent from a GBT-sponsored voxelotor clinical study
* Known hypersensitivity to voxelotor or any other components of the study drug
* Use of St. John's wort, sensitive cytochrome P450 (CYP) 3A4 substrates with a narrow therapeutic index, or moderate or strong CYP3A4 inducers within 30 days of Day 1
Towards RECOVER: Outcomes and Needs Assessment in Intensive Care Unit (ICU) Survivors of Prolonged Mechanical Ventilation and Their Caregivers

Advances in critical care medicine have dramatically improved the survival of critically ill patients requiring prolonged mechanical ventilation. However, there are no systematic follow-up, rehabilitation, or psychoeducational interventions for these vulnerable patients or their family caregivers who contribute to survivor recovery and rehabilitation. Major barriers to developing these programs for survivors of prolonged mechanical ventilation and their caregivers include the following:

1. There is inadequate information about the determinants of long-term functional outcomes for a diverse group of survivors of prolonged mechanical ventilation.
2. There is inadequate information about the needs of survivors of prolonged mechanical ventilation and their family caregivers across the trajectory of illness (i.e., from the ICU to the community).
3. There is a poor understanding of the development of ICU-acquired muscle injury.

Towards RECOVER is the very first study to identify survivors of prolonged mechanical ventilation who are at-risk for poor functional outcomes, to identify elements of the care-giving situation that put caregivers at risk for poor quality of life and mental health, to catalogue the rehabilitative needs of patients and family caregivers across the illness trajectory, and to evaluate the mechanism of critical illness associated muscle injury.

The RECOVER Program consists of Four Phases:

* Phase I: Towards RECOVER
* Phase II: RECOVER development and pilot testing
* Phase III: RECOVER randomized controlled trial
* Phase IV: Long-term implementation of RECOVER


Eligibility Criteria:
Inclusion Criteria:

* Older than 16 years of age.
* Mechanically ventilated for a minimum of one week in study ICU.

Exclusion Criteria:

* Catastrophic Neurological Injury in the opinion of the attending intensivist (ex. Grade V SAH or massive CVA).
* Pre-existing Formal diagnosis of neuromuscular disease.
* Non-ambulatory prior to hospital or ICU admission.
* Anticipated death or withdrawal of life sustaining treatment within 48 hours.
* History of psychiatric illness with documented admission.
* Patient is not fluent in English.
* Documented discussion re: imminent withdrawal of life sustaining treatment.
* Lives greater than 300 km from referral centre.
* Patient no living at a fixed address.
* Physician refusal.
* Patient of SDM (substitute decision maker) refuses consent.
* No next of kin of SDM available (if patient unable to provide consent).
Biomarkers in Predicting Response to Tamoxifen and Letrozole in Postmenopausal Women With Primary Breast Cancer Treated on Clinical Trial CAN-NCIC-MA17

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how well patients respond to treatment.

PURPOSE: This laboratory study is looking at biomarkers that may predict response to tamoxifen and letrozole in postmenopausal women with primary breast cancer treated on clinical trial CAN-NCIC-MA17.

OBJECTIVES:

* Assess the prognostic utility of the MGH 2-gene and the GHI 21-gene expression signatures in postmenopausal women with primary breast cancer treated with tamoxifen followed by either placebo or letrozole on clinical trial CAN-NCIC-MA17.
* Assess the ability of the MGH 2-gene and the GHI 21-gene expression signatures to predict responsiveness to letrozole.
* Compare the prognostic utility of quantitative immunofluorescence vs standard immunohistochemistry of estrogen receptor, progesterone receptor, HER-2, tumor aromatase, cyclooxygenase-2, GATA-3, and NAT-1 in these patients.
* Assess the ability of quantitative immunofluorescence and standard immunohistochemistry of these proteins to predict responsiveness to letrozole in these patients.
* Use gene discovery from formalin-fixed, paraffin-embedded tumor specimens to identify novel gene expression profiles that may predict outcome and responsiveness to letrozole in these patients.

OUTLINE: This is a controlled study.

Formalin-fixed, paraffin-embedded breast tumor tissue samples are analyzed for MGH 2-gene and GHI 21-gene expression signatures using real-time quantitative polymerase chain reaction. Immunohistochemistry and immunofluorescence are used for analysis of estrogen receptor, progesterone receptor, HER-1 and -2, aromatase, GATA-3, NAT-1, and cyclooxygenase-2. Microarray hybridization is used to identify novel gene expression signatures.

PROJECTED ACCRUAL: A total of 957 specimens will be accrued for this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Histologically or cytologically confirmed primary invasive breast carcinoma resected at time of original diagnosis
* Treated on clinical trial CAN-NCIC-MA17
* Hormone receptor status:

  * Estrogen or progesterone receptor positive tumor

PATIENT CHARACTERISTICS:

* Female
* Postmenopausal

PRIOR CONCURRENT THERAPY:

* Not specified
The Role of Standardized Training in the Diagnosis of Interstitial Lung Disease by Transbronchial Lung Cryobiopsy

The aim of this study was to conduct a prospective randomized controlled trial to design simulator and in vitro lung standardized training, to perform a learning curve evaluation of transbronchial lung cryobiopsy (TBLC) operating physicians, and to assess the role of standardized training in TBLC.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* suspected ILD.
* ≤3 months since HRCT
* Forced vital capacity (FVC) ≥50% of predicted value
* Diffused lung carbon monoxide (DLCO) ≥35% predicted value
* Echocardiography ≤ 12 months
* Estimated pulmonary artery systolic pressure ≤40 mmHg
* Body mass index (BMI) ≤35 kg/m2
* Patient consent for experimentation

Exclusion Criteria:

* Patients with platelet counts less than 50 × 109/L or prothrombin time international normalized ratio (INR) higher than 1.5
* Patients refused to participate in the experiment
Vertical Transmission of Hepatitis C in Adult Children of Female Baby Boomers

The investigators aim to determine the prevalence of hepatitis C in the adult children of female baby boomers. During the years baby boomers were becoming pregnant, hepatitis C testing was either not available or was not standard of care. Because of this, participants' children may be unaware of participants' risk of hepatitis C.


Eligibility Criteria:
Inclusion Criteria:

Mothers:

* Born between 1/1/45-12/31/64
* Black or white race
* Active or prior infection with hepatitis C
* Have at least one living adult child over the age of 18

Children:

* ≥18 years of age
* Born to mother with current or prior HCV infection, with likely timing of HCV acquisition prior to or during pregnancy
* Mother gave informed consent for child to be approached for study participation

Exclusion Criteria:

Mothers:

- Unwilling to disclose hepatitis C status to children
eVusheld Assessment reaL wORld Effectiveness in DoD Health System

An AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population treated in DoD Health system.

This a Phase IV observational, secondary data study to assess the effectiveness of Evusheld in preventing COVID-19 infection and severe outcomes using the electronic medical records from the nationwide integrated health system.

The study is designed as an AstraZeneca-sponsored observational, electronic healthcare record (EHR)-embedded retrospective cohort study to assess the real-world effectiveness of EVUSHELD against SARS-CoV-2 infection, COVID-19-related hospitalization, and other COVID-19 related outcomes in the total EUA-eligible patient population in the DoD health system.

Eligibility Criteria:
Inclusion Criteria:

1. Receipt of Evusheld under the FDA EUA for Evusheld
2. Eligibility for Evusheld use under the EUA. -

Exclusion Criteria:

* None
Effect of Artificial Tears on Biometry

The purpose of this study is to determine if measurements for cataract surgery are improved with use of additional lubrication with artificial tears. The research study is being done to optimize measurements and provide patients with the best visual outcomes after cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Male or female ≥ 18 years of age
* Documentation of bilateral age-related senile cataracts diagnosis

Exclusion Criteria:

* Patients currently using regularly scheduled artificial tears. Patients with infrequent or irregular use of artificial tears may not be excluded from the study.
* Patients using contact lenses.
* Patients with any other surface pathology affecting corneal biometric measurements determined with slit-lamp examination or medical history.
Phase I Study of SB-480848(Darapladib) -Repeat Dose Study in Healthy Japanese Male Subjects-

This study is being conducted to provide safety, tolerability, PK and PD data in repeat dosing that will allow further studies with darapladib in Japanese patients


Eligibility Criteria:
Inclusion criteria:

* Healthy Japanese adult males between 20 and 64 yeas of age, inclusive.
* Healthy subjects are defined as individuals who are free from clinically significant disease as determined by their medical history, physical examination, clinical laboratory examinations, vital sign, 12-lead ECG, immunology tests and urinary drug screen test.
* Bodyweight \>50 kg and body mass index (BMI) between 18.5 and 25.0 at screening.
* Subjects must be capable of providing written informed consent, which includes compliance with the requirements and restrictions listed in the consent form.
* Baseline QTc interval \<450 msec.
* Non-smoker or ex-smoker having ceased smoking for at least 6 months.
* Clinical laboratory examination (AST, ALT, ALP and GGT) at screening are within the normal range.
* The subject is able to attend all visits and complete the study.

Exclusion criteria:

* Any clinically relevant abnormality identified on the screening physical examination, vital sign measurement, 12-lead ECG recording and/or clinical laboratory examination that is deemed by the principal investigator and/or medical monitor to make the subject ineligible for inclusion because of a safety concern.
* History of regular alcohol consumption exceeding, on average, 14 drinks/week for men (1 drink = 5 ounces (150 mL) of wine or 350 mL of beer or 1.5 ounces (45 mL) of 80 proof distilled spirits) within 6 months of screening.
* Positive for urine drug at screening.
* Positive for syphilis, HIV antibody, Hepatitis B surface antigen, Hepatitis C antibody or HTLV-1 antibody at screening.
* Use of prescription or no-prescription drugs, including vitamins, herbal and dietary supplements (including St John's Wort) within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study medication.
* Consumption of grapefruit juice or food within 7 days prior to the first dose of study medication.
* A history of cholecystectomy or biliary tract disease including a history of liver disease with elevated liver function tests of known or unknown etiology.
* Donation of blood in excess of 400mL within 4 months or 200mL within 1 months prior to at screening.
* History of drug abuse, or current conditions of drug abuse or alcoholism.
* Participation in a clinical study or post-marketing study with an investigational or a non-investigational product or device within 4 months of preceding the first dose of study medication.
* Participation in another clinical study or post-marketing study in which the subject is or will be exposed to an investigational or a non-investigational product or device.
* History of asthma, anaphylaxis or anaphylactoid reactions, severe allergic responses.
* The subject has an allergy for any drug or idiosyncrasy. This excludes a pollen allergy without current symptoms.
* History of sensitivity to heparin or heparin-induced thrombocytopenia.
Effect of Opioids on Central Control of Ventilation in Children With Obstructive Sleep Apnea

Children OSA exhibit varying responses to opioids. It is unknown if the degree of intermittent hypoxemia results in different opioid sensitivity

Ventilatory suppression in children following opioid administration is of obvious concern, especially following routine surgical procedures (i.e. adenotonsillectomy). It is thought that patients with obstructive sleep apnea (OSA) have increased sensitivity to opioids, and especially in opioid naïve patients. Recent evidence in children suggests that patients with moderate to severe OSA may not predispose patients to increased opioid sensitivity in the form of respiratory depression when compared with patients that do not have OSA. However, what is not known is wether the degree of hypoxemia experienced by patients effects the opioid sensitivity. The aim of this study is to identify if children with known OSA experience a difference in opioid induced respiratory depression based on the degree of hypoxemia.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing tonsillectomy or adenotonsillectomy
* Ages 2 to up to 8 years
* Preoperative sleep study demonstrating obstructive sleep apnea
* Intubation without medication (e.g. no propofol prior to intubation)
* Requirement for airway instrumentation: LMA or ETT
* Inhalation induction of anesthesia

Exclusion Criteria:

* No obstructive sleep apnea
* Central sleep apnea events \>5/hour
* IV induction of anesthesia
* Syndromic patients
* Known or suspected difficult airway
* Allergy to Fentanyl
* Known cardiovascular medications
* Pulmonary hypertension
* Total intravenous anesthesia required
* Parental refusal