cyrilzakka/clinical-trials huggingface dataset:
Biomarkers for Clinical Classification and Outcomes of Immune Checkpoint Inhibitor-Related-Related Myocarditis in Lung Cancer

This study aims to investigate the clinical classification and outcome-related biomarkers of immune checkpoint inhibitor (ICI)-related myocarditis in patients with lung cancer.A total of 50 patients with ICI-related myocarditis will be enrolled, including 25 with severe/critical myocarditis and 25 with subclinical/mild myocarditis. Blood samples will be collected at baseline and at follow-up time points (3 days, 7 days, and before discharge). Traditional myocardial injury markers, iron metabolism-related markers, and immunological markers will be measured and compared between groups. Changes in biomarkers after treatment will also be assessed. Clinical information such as in-hospital mortality and 3-month survival rates will be integrated to develop a severity assessment model. This model aims to evaluate disease severity and prognostic risk accurately by combining biomarkers, enhancing their application in clinical management.


Eligibility Criteria:
Inclusion Criteria:

* Pathologically confirmed lung cancer and having received at least one dose of immune checkpoint inhibitor therapy;
* Clinically diagnosed with immune checkpoint inhibitor-related myocarditis;
* Aged 18 years or older;
* Voluntarily signed informed consent after being fully informed.

Exclusion Criteria:

* Pregnancy or breastfeeding;
* Presence of severe underlying cardiovascular diseases or recent acute cardiac events (e.g., myocardial infarction, severe arrhythmia);
* Concurrent other malignancies, immunosuppressive diseases, or autoimmune diseases;
* Inability to complete the required examinations and follow-ups specified in the study.
A Study to Evaluate the Effects of NST-4016 on QT/Corrected QT (QTc) Interval

This is a Phase 1, single centre, randomised, double blind (except for moxifloxacin), placebo and positive controlled, 4 way crossover study assessing the ECG effects of therapeutic and supratherapeutic doses of icosabutate in healthy male and female subjects.


Eligibility Criteria:
Inclusion Criteria:

* 1. Males or females, of any race, between 18 and 55 years of age, inclusive, at Screening.
* 2. Body mass index (BMI) between 18.0 and 33.0 kg/m2, inclusive, at Screening
* 3. In good health

Exclusion Criteria:

* 1. An uninterpretable or abnormal ECG at Screening and/or Check in
* 2. History of risk factors for Torsades de Pointes
* 3. sustained supine systolic blood pressure \>140 mmHg or \<90 mmHg
* 4. Unstable cardiovascular disease, including recent myocardial infarction or cardiac arrhythmia.
* 5. Female subjects who are pregnant (or planning to become pregnant within 90 days after the final dose administration) or are currently lactating
* 6. Subjects who, in the opinion of the Investigator (or designee), should not participate in this study
Clinical Evaluation of the QuantiFERON CMV Assay

Validate the use of the device in the clinical setting for assessing the risk of CMV Infection in SOT recipients after the completion of antiviral prophylaxis.


Eligibility Criteria:
Inclusion Criteria:

* Adult CMV D+/R- liver, kidney, heart, pancreas, lung, intestinal, or combined transplant recipients that are 18 years of age or older.
* Scheduled to receive between 3 to 6 months of antiviral prophylaxis
* Provide Informed Consent

Exclusion Criteria:

* Subjects less than 18 years old
* Scheduled to receive longer than 6 months or shorter than 3 months of prophylaxis
* Unable to provide Informed Consent
Combined Kidney and Hematopoietic Stem Cell Transplantation for Tolerance Induction

Combined transplantation of kidney and bone marrow between HLA-matched sibling donor-recipient pairs to induce immune tolerance in order to enable complete discontinuation of immunosuppressive therapy without kidney rejection. Hematopoietic stem cells are collected from the donor 4 to 8 weeks before kidney transplantation, CD34 cells are enriched by positive selection and cryopreserved. The day after kidney transplantation the recipient starts conditioning therapy with thymoglobuline, total lymphoid irradiation, steroids, tacrolimus and mycophenolate mofetil. Eleven days after kidney transplantation the stem cell graft is thawed and infused to the recipient. If mixed donor chimerism is successfully maintained more than 6 months without rejection, then immunosuppression may be tapered off until complete discontinuation.


Eligibility Criteria:
Inclusion Criteria:

* Age older than 18 years
* Matched siblings
* No contra-indication to thymoglobuline or total lymphoid irradiation

Exclusion Criteria:

* Pregnant women or breast feeding
* Infection with HIV, HBV or HCV
* Previous or presnt malignancy
A Phase 1/2 Study of HKI-272 (Neratinib) in Combination With Paclitaxel (Taxol) in Subjects With Solid Tumors and Breast Cancer

The purpose of this study is to learn whether it is safe and effective to administer HKI-272 (neratinib) in combination with paclitaxel in patients with breast cancer.


Eligibility Criteria:
Inclusion Criteria:

Inclusion criteria for both parts of clinical trial:

* Good performance status
* Normal ejection fraction
* Adequate cardiac, kidney, and liver function
* Adequate blood counts
* At least one measurable target lesion
* Negative pregnancy test for female subjects

Inclusion Criteria for Part 1 Only:

- Pathologically confirmed solid tumor not curable with available standard therapy

Inclusion Criteria for Part 2 Only:

* Pathologically confirmed breast cancer
* HER2 positive tumor
* Prior treatment with Herceptin

Exclusion Criteria:

Exclusion criteria for both parts of clinical trial:

* Major surgery, radiotherapy, chemotherapy or investigational agents within two weeks of treatment day 1
* Subjects with bone or skin as the only site of disease
* Active central nervous system metastases
* Significant cardiac disease or dysfunction
* Significant gastrointestinal disorder
* Inability or unwillingness to swallow HKI-272 capsules
* Prior exposure to HKI-272 or other HER2 targeted agents, except trastuzumab (Part 2 only). Prior lapatinib is permitted in arm B of part 2.
* Treatment with a taxane within 3 months of treatment day 1
* Grade 2 or greater motor or sensory neuropathy
* Pregnant or breast feeding women
* Known hypersensitivity to paclitaxel or Cremophor EL
* Prior treatment with anthracyclines with cumulative dose of \>400 mg/m\^2
* Any other cancer within 5 years with the exception of contralateral breast cancer, adequately treated cervical carcinoma in situ, or adequately treated basal or squamous cell carcinoma of the skin

Exclusion Criteria for Part 2 Only:

- More than 1 (arm A) or 3 (arm B) prior cytotoxic chemotherapy regimen for metastatic disease
A Comparative Confirmatory Study of STN1012600 in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

To investigate whether the IOP lowering efficacy of STN1012600 ophthalmic solution 0.002% is non-inferior to that of latanoprost 0.005% in subjects with POAG or OHT after treatment for 4 weeks.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older.
* Diagnosis of POAG or OHT in both eyes, or one eye with POAG and the other with OHT.
* Corrected Visual Acuity of +0.60 logMAR (Decimal visual acuity 0.3) or better in each eye.

Exclusion Criteria:

* Presence of any active severe external ocular disease, inflammation, or infection of the eye and/or eyelids in either eye.
* History of severe ocular trauma in either eye.
* Any condition that prevents clear visualization of the fundus in either eye.
* Known allergy, hypersensitivity or contraindications to any components of the study medications or other study related procedures/medications.
* History of ocular surgery specifically intended to lower IOP in either eye.
* History of keratorefractive surgery in either eye.
* Females who are pregnant, nursing, or planning a pregnancy.
* Subjects with known or suspected drug or alcohol abuse.
* Participation in other investigational drugs or device clinical trials within 30 days prior to Screening.
* Any decision by the Investigator to terminate a subject in screening or declare any subject ineligible for any sound medical reason.
Specified Drug Use-Results Survey of Regnite

This study is to investigate the long-term safety and efficacy and the information on the proper use of Regnite® under conditions of daily clinical use.

Sleeping condition and severity of restless legs syndrome (RLS) were recorded at the start and during the treatment. The treatment period is scheduled to last 52 weeks in principle. For patients completing or discontinuing the use of Regnite® within 52 weeks, follow up on the withdrawal and rebound syndrome will be conducted up to 4 weeks of completion or discontinuation.

Eligibility Criteria:
Inclusion Criteria:

* Patients with moderate to severe idiopathic restless legs syndrome

Exclusion Criteria:

* Patients with a history of hypersensitivity to any ingredients in Regnite or gabapentin
* Patients with severely impaired renal function (creatinine clearance of less than 30 mL/min)
Bradycardia Recognition and Detection in Young Infants Part-I

This prospective cohort study will determine the diagnostic accuracy of the Owlet OSS 3.0 monitor for the detection of episodes of bradycardia and/or hypoxemia among infants.

We will attach an Owlet monitor to infants for a 48-hour period. We will prospectively collect data from this device to determine the accuracy of bradycardia and hypoxemia detection compared with hospital monitors. In addition, we will collect simultaneous high-resolution real time cardiorespiratory data from Philips MP70 patient monitors at the University of Alabama at Birmingham.

Eligibility Criteria:
Inclusion Criteria:

* Off ventilatory support/NCPAP/HFNC and phototherapy for \> 48 hours
* Less than one-year corrected age
* Current weight \>1500 grams
* Parents/legal guardians have provided consent for enrollment

Exclusion Criteria:

* a major malformation
* a neuromuscular condition that affects respiration or causes apnea
* active skin breakdown or skin infection
* terminal illness or decision to withhold or limit support
* We will exclude data from infants who develop shock/sepsis or require ventilatory support or phototherapy during the study period.
Health Literacy for Children With Atopic Dermatitis and Their Caregivers

The purpose of this study is to determine the effectiveness of additional nursing instruction for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the University of Missouri Dermatology clinic.

The purpose of this study is to determine the effectiveness of additional nursing instruction for the caregivers of newly diagnosed pediatric atopic dermatitis patients at the University of Missouri Dermatology clinic. Caregivers of children with atopic dermatitis will be randomized to one of two instruction/education procedures. The goal is to determine if improved retention of information by caregivers/parents of children with atopic dermatitis is associated with better patient outcomes.

Eligibility Criteria:
Inclusion Criteria:

* New clinical diagnosis of pediatric atopic dermatitis, or existing atopic dermatitis but new patient to MU dermatology
* Age 7 or under

Exclusion Criteria:

* Age 8 or above
Investigating the Diagnostic Performance of High-resolution Specimen PET-CT in Determining Margin Status in Cancer Resection

Surgical removal is the treatment for many different cancers. Patient outcomes depend on complete cancer removal with no tumour present at the edge of the section removed (specimen). If cancer is left behind, then patients might need additional cancer treatment. Regardless of whether extra treatment is required, knowing that removal was incomplete causes anxiety. The need for a wide removal of the tumour must be balanced against the harm caused by more extensive surgery particularly when important organs and structures are close by. The fact that the cancer is not visible to the surgeon during the operation means that there is an element of guesswork when deciding how much tissue to remove. This study is examining a technique that the investigators hope will provide surgeons with more precise information about how much tissue to remove during cancer operations using a new type of Positron Emission Tomography-Computed Tomography (PET-CT) scanner. Patients with different types of cancer (e.g. prostate, head and neck cancer) will be injected with a small amount of radioactive tracer at the beginning of their cancer operation. This tracer will attach itself to the cancer cells. Once the surgical specimen is removed it will be placed into the specimen PET-CT scanner so that the surgeon can see the cancer within the specimen. The investigators will then compare the results of the scan of the specimen taken during the operation with the results when the whole specimen has been examined under the microscope. Examination under the microscope is considered to be the gold standard for deciding whether the cancer removal operation has been successful. This study aims to tell us how accurate the new specimen PET-CT scanner results are, and so whether or not surgeons can rely on the results to guide them during operations in the future.


Eligibility Criteria:
Inclusion Criteria:

For prostate cancer patients:

1. At least 18 years old at time of consent.
2. Listed for Robotic Radical Prostatectomy.

For head and neck cancer patients:

1. At least 18 years old at time of consent.
2. Listed for resection of oral squamous cell carcinoma head and neck cancer resection.
3. Specimen able to fit into Xeos Aura specimen container.

Exclusion Criteria:

For prostate cancer patients:

1. General or local contra-indications for resectional surgery.
2. Lacks capacity to provide informed consent.
3. Currently participating in another interventional research study that in the judgment of the investigator would negatively affect the participant and/or this study's data integrity.

For head and neck cancer patients:

1. General or local contra-indications for resectional surgery.
2. Lacks capacity to provide informed consent.
3. Pregnant or breast feeding patient.
4. Currently participating in another interventional research study that in the judgment of the investigator would negatively affect the participant and/or this study's data integrity.
Treatment of Hypertension

To determine whether the long-term treatment of essential hypertension without significant target organ disease materially influenced mortality and/or cardiovascular renal morbidity.

BACKGROUND:

This grant-supported, cooperative, fixed-protocol clinical study was initiated in 1966 and followed a cooperative study of the treatment of renal hypertension initiated in 1960 to evaluate the relative efficacy of several recognized drug regimens for reduction of blood pressure. Six centers (USPHS hospitals) and a coordinating center were involved in the trial.

DESIGN NARRATIVE:

Randomized, double-blind, fixed sample. Three hundred and eighty nine eligible patients were assigned to drug therapy consisting of chlorothiazide plus Rauwolfia serpentina or to placebo.

The study completion date listed in this record was inferred from last publication listed in the Citations section of this study record.

Eligibility Criteria:
Men and women, ages 21-55. Mild essential hypertension (diastolic blood pressure over 90 mm Hg.
Heart-focused Anxiety in Patients With Heart Failure and ICD

The aim of the present study is to measure heart-focused anxiety, general anxiety, depression, PTSD and quality of life as well as type D personality in patients with heart failure before and after the implantation of a cardioverter defibrillator (ICD) and/or assist device (AD).

In patients with heart failure and implantable Cardioverter Defibrillator (ICD) psychological comorbidities such as heart focused anxiety and depression often occur. These psychological factors may have negative effects on compliance as well as on the development of the cardiac disease and therefore on rehospitalization and mortality rates.

A personality structure where negative affect is paired with social inhibition (the inability to communicate ones feelings to others) can often be found in patients with cardiovascular disease. This so-called type D personality is also associated with a worse prognosis.

It is of interest whether, and if so in what way, the implantation of an ICD can affect the psychological well-being and through that the prognosis of the heart failure patient.

The goal of this study is therefore to investigate the effect of ICD implantation on heart-focused anxiety, depression, possible traumatization and quality of life in patients with heart failure with consideration of a possible moderating effect of the type D personality.

Furthermore, the impact of the above stated psychological factors on rehospitalization and mortality, as well as on frequency of shocks shall be examined.

Vice versa, the frequency of shocks or the impact of being shocked at all on psychological factors is of interest.

Eligibility Criteria:
Inclusion Criteria:

* heart failure, indication for an implantable Cardioverter Defibrillator

Exclusion Criteria:

* psychosis; advanced dementia; drug abuse
The Clinical Study of Bundle Measures to Improve the Success Rate of Patients With Difficult Ventilator Weaning

Based on nutritional support, Cardiopulmonary rehabilitation and Levosimendan Bundle measures, and making beside checklist of patients with difficult ventilator weaning; Implementation of nutritional risk, respiratory function, and cardiac function assessment prior to weaning; Regulate the procedure to solve the problem of difficult-weaning patients with Non neurogenic disease in ICU. Thereby,improve the success rate of weaning patients, so as to shorten the ICU hospitalization time, reduce medical costs, reduce the complications of mechanical ventilation, improve the patient's quality of life.

Older than 16 years of age, ventilator therapy more than 1 weeks, Ventilator parameters meet the standard of ventilator removal, repeated more than 3 times SBT not successful, or within a short period of time within a week of successful weaning, no other new incentives to need ventilator support again, and delayed weaning from ventilator more than 1 months.

Eligibility Criteria:
Inclusion Criteria:

Older than 16 years of age, ventilator therapy more than 1 weeks,ventilator parameters up to Weaning standard, repeated more than 3 times Spontaneous Breathing Test(SBT) not successful, or within a short period of time within a week of successful weaning, no other new incentives to re machine induced delayed more than 1 months or more offline.

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Exclusion Criteria:

Mechanical ventilation patients who are clearly defined as neurological disorders or advanced tumor wasting diseases, as well as those without informed consent.

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Feasibility of a Software App for Testing Inattention in Delirium

This qualitative study aims to evaluate the usability of a smartphone application called DelApp. The study will assess usability and acceptability of the software app by asking 40 clinicians to administer the DelApp assessment to consented patient and clinicians. Feedback will be collected through semi-structured interviews with the clinicians. The feedback will be used to optimise the software application in preparation for formal validations studies.

Delirium is an acute, serious syndrome involving abnormalities in attention, arousal and cognition. Delirium affects 1 in 8 hospital patients. Delirium is linked to a higher risk of death, increased length of stay, and substantial patient and carer distress. Despite its massive medical importance, delirium is grossly underdetected, with rates of formal detection of 20% or less.

Investigators previously developed a new neuropsychological test for the objective measurement of inattention in delirium, implemented on a computerised device (Delbox). A prototype software application for smartphones (DelApp) has been developed based on the 'Delbox' tests. Findings from two pilot studies suggest that the DelApp performs well as a method for objectively measuring attention in delirium.

As part of a new programme of work on attentional tests for delirium, formally funded by the Medical Research Council (grant value £1.01M), investigators plan further studies to refine the DelApp before conducting larger scale formal studies. The reasons for doing these additional studies are to: (1) shorten the duration of the DelApp assessment; (2) ask end users (i.e. clinicians) to evaluate the user interface; (3) gather feedback from end users regarding the ease of use of the test; and any other feedback from clinicians and patients; and finally (4) develop the DelApp software application further based on user feedback.

Here investigators propose a preliminary qualitative study to evaluate feasibility of the optimised DelApp test (points 2 and 3). Investigators will assess usability and acceptability by asking 40 clinical staff to administer the DelApp test to consented patients (N=10) and colleagues (approximately N=30). Feedback will be collected from clinicians and patients through semi-structured interviews. The outcomes of this feasibility study will make further optimisation of the app possible, in preparation for formal validation studies.

Eligibility Criteria:
Inclusion Criteria:

* Native or fluent English speaker

  * Capacity to give consent to participate in the study
  * Aged 65 or over

Exclusion Criteria:

* Vision, hearing or speech impairment severe enough to preclude testing and interview.

  * Known or suspected cognitive impairment including dementia
  * Photosensitive epilepsy
Protein Balance and Body Composition in Preterm Infants

The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain in very low birth weight preterm infants.

Aim of the study is to investigate protein balance according to feeding regimen and the association between human milk feeding and fat free mass content at term corrected age in a cohort of very low birth weight infants.

Nutritional management of preterm infants aims to approximate tissue growth and body composition of a foetus of same postconceptional age. The adequacy of the quality of protein supply could influence the rate and the relative composition of weight gain.

Aim of the study is to investigate protein balance according to feeding regimen and the association between exclusive human milk feeding and fat free mass content at term corrected age in a cohort of very low birth weight infants.

A prospective observational study. Infants are included according to inclusion criteria. Enrollment is performed at hospital discharge. Infants are divided into two groups (exclusively human milk or exclusively formula) according to own mother's milk availability. At enrollment macronutrients' intakes and protein balance are determined. Anthropometric measurements and body composition are also assessed. Nutritional composition of human milk is calculated by infrared spectroscopy (MIRIS® AB, Uppsala, Sweden). Protein balance is determined according to nitrogen balance standard method. Body composition is assessed by an air-displacement plethysmography system system (PEA POD Infant Body Composition System, COSMED SRL, Roma, Italy). At term corrected age anthropometry and body composition assessments are repeated.

Eligibility Criteria:
Inclusion Criteria:

* gestational age ≤32 weeks
* birth weight \< 1500 grams
* birth weight ≥10th percentile according to Fenton's growth chart
* stable clinical conditions at discharge
* feeding by mouth with either exclusively human milk or formula at discharge

Exclusion Criteria:

* congenital or chromosomal abnormalities
* conditions that could interfere with growth such as chronic lung disease, neurological disorders, metabolic, cardiac disease and abdominal surgery, renal failure and/or sepsis (defined as a positive blood culture).