cyrilzakka/clinical-trials huggingface dataset:
The Study Of An Oral Drug Called A Radiation Sensitizer In Patients With Newly Diagnosed Small Cell Lung Cancer (SCLC)

This study will gather information on the effectiveness and safety of a treatment program for small cell lung cancer (SCLC) that uses an FDA approved chemotherapy combination, radiation therapy, and an oral investigational drug that may enhance the effects of radiation therapy. Study patients will receive two additional courses of the standard chemotherapy combination after completing radiation therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have newly diagnosed, limited stage SCLC (small cell lung cancer), with no prior radiotherapy. Patients are allowed to have had a resection or biopsy.
* Women of reproductive potential must have a negative serum pregnancy test at the study screening visit.
* Patients must give written informed consent to participate in the study.
* Patients must be able to take oral medication.
* Patients should be completely recovered from recent surgery.
* Laboratory criteria: Patients must have adequate bone marrow reserve and adequate kidney and liver function.
* Patients must be evaluated by the radiation oncologist prior to study entry.

Exclusion Criteria:

* Extensive Stage SCLC.
* Women who are pregnant or lactating.
* Use of an investigational drug within 30 days prior to the first dose of study medication.
* Any medically/clinically significant active infection.
* Symptoms of the SCLC spreading to the brain.
* Patients with limited stage SCLC who have undergone complete resection with no measurable disease prior to starting chemotherapy.
* Severe medical problems, unrelated to SCLC, that would limit the patient's full ability to follow all study rules and procedures, or that would expose the patient to extreme risk.
* Other ongoing, immunotherapy or radiotherapy being administered at the time as study participation.
Patient Outcomes and Gingival Blood Flow Using Laser Doppler Flowmetry Following the Use of Episil on Free Gingival Graft Donor Sites

The hypothesis for the present study is that patient-based outcomes and gingival blood flow will be more favorable for the free gingival graft (FGG) donor sites being covered by the test wound dressing material episil compared to the control dressing.


Eligibility Criteria:
Inclusion Criteria:

* patient of record at UTHealth School of Dentistry Houston Texas
* signed treatment plan for a FGG
* the ability to provide research informed consent

Exclusion Criteria:

* any allergies to any of the ingredients in episil including allergies to peanuts, soy or peppermint oil
* smokers
* pregnant or breast feeding women
* inability or unwillingness to provide informed consent
Establishment of a PDT Patient Registry

This is a non-intervention patient registry to gather data on the use of photodynamic therapy under real-life conditions. It will involve up to 20 sites in USA.

The purpose of this patient registry is to collect information about a patient's cancer treatment, photodynamic therapy (PDT), used alone or in combination with surgery, chemotherapy and radiotherapy. Patients will be registered either before or after PDT is performed, regardless of the indication. Analysis of this information may help to refine the treatment care. Data collected in the registry includes patient characteristics/demographics, disease characteristics, treatment details (photodynamic therapy, radiation, chemotherapy, surgery, etc.), side effects, and survival outcomes. By participating in this registry, patients will not be asked to do anything that would not ordinarily be done as a matter of routine care including clinical assessments, laboratory tests, radiology procedures, and treatments. Information on disease, condition, and treatment will be recorded in the registry during routine visits.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients (≥ 18 years of age) treated with PDT.
* Women and men and members of all races and ethnic groups.
* Subjects may have received prior treatment for their cancer.
* Subjects to give a written informed consent for prospectively collected data.

Exclusion Criteria:

* None.
A Prospective Study of a New Immunological Fecal Occult Blood Test

The purpose of the investigators study is to evaluate the diagnostic ability of a new immunological fecal occult blood test in Cuban patients undergoing colonoscopy .

Colorectal cancer is a major cause of cancer deaths in many countries. Therefore, the importance of screening for the early detection of colorectal cancer is evident. Fecal occult blood screening is proving to be an effective tool for detecting premalignant adenomas and colon cancer since the guaiac-based test was introduced in the late 1960s. However, several immunochemical fecal occult blood tests (IFOBTs) have become commercially available and the majority of these have demonstrated equal or superior sensitivities and specificities than the guaiac-based tests. Therefore, IFOBTs are replacing guaiac based tests despite their higher costs.In this study we evaluate the diagnostic accuracy of a new IFOBT and compare with the findings on colonoscopy.

Eligibility Criteria:
Inclusion Criteria:

* Patients (men or women) that are \>18 years of age referred to colonoscopy.

Exclusion Criteria:

* Visible rectal bleeding
* Known diagnosis of inflammatory bowel disease
* Hematuria
* Menstruation at the time of obtaining a stool specimen
* Patients taking medication such as non steroids anti inflammatory drugs and anticoagulants
Characterization of Rectal Cancer Hypoxia Using pO2 Histography and Immunohistochemistry for Hypoxia-Related Proteins

The purpose of this study is to see if the cells in rectal cancer are oxygen-starved, or hypoxic. We know that as cancers grow bigger, parts of them are cut off from the oxygen supply and they become hypoxic, basically, lacking oxygen. Research has shown that cells that are oxygen-starved respond differently to treatment such as chemotherapy and radiation when compared to cells that are oxygen rich.


Eligibility Criteria:
Inclusion Criteria:

* Biopsy proven adenocarcinoma of the rectum. If a biopsy was taken at an outside hospital, the slides and diagnosis will be reviewed and confirmed by a pathologist at MSKCC.
* Mid to distal rectal tumors not requiring pre-op radiation or chemotherapy
* Age ≥ 18
* Age \< 90
* Karnofsky performance status ≥ 60
* Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

* Current pregnancy
* Uncontrolled intercurrent illness that would limit compliance with study requirements.
The Alpha-1 Foundation's and University of Florida's Alpha-1 Coded Testing (ACT) Study

The Alpha-1 Coded Testing (ACT) Study was established to study genetic testing and outcomes of individuals at risk for alpha-1 antitrypsin deficiency.

Genetic testing for alpha-1 antitrypsin deficiency is sometimes delayed despite established testing indications. All genetic tests have risks and possible benefits. The ACT study evaluates the population demographics, reasons for testing, and outcomes through a confidential testing program. Co-morbidities of alpha-1 antitrypsin deficiency other than lung and liver disease are being investigated. Concerns about genetic confidentiality are lessened in this study by a coded testing procedure that returns results through the mail to study participants.

Eligibility Criteria:
Inclusion Criteria:

* Individuals of any age at risk for alpha-1 antitrypsin deficiency on the basis of symptoms or family genetic risk.

Exclusion Criteria:

* Any person who has already had genotype and AAT level testing completed and has a qualified result.
CORRECTION OF EAR DEFORMITIES IN NEWBORNS BY MODELING, COMPARISON OF TWO PROTOCOLS

Evaluation of the non-inferiority of the custom-made device developed in the maxillofacial surgery department of Caen University Hospital compared to the device from the EarWell™ group


Eligibility Criteria:
Inclusion Criteria:

* Newborn, age between 8 days and 1 month
* newborn with ear malformation

Exclusion Criteria:

* Total chondrocutaneous agenesis of the ear
* polymalformative syndrome
* age greater than 4 weeks
* parental refusal
Online Exposure Therapy for Obsessive-Compulsive Disorder (OCD) Study

The overarching goal of this protocol is to investigate mechanisms that influence symptom outcomes of exposure and response prevention (ERP) therapy for OCD. Mechanisms may include affective processes, learning factors, cognitive factors, or other constructs that could influence treatment outcomes. The study team will conduct this research within the context of an effective online treatment for OCD called OCD-NET. OCD-NET is bibliotherapy with coaching and its content is reflective of standard care for OCD.


Eligibility Criteria:
Inclusion Criteria:

* English-speaking
* Located within the United States
* 18-90 years old
* Able to provide consent
* Current diagnosis of OCD as assessed by clinical interview

Exclusion Criteria:

* Adults unable to consent
* Individuals who are not yet adults (infants, children, teenagers)
* Participants currently located outside of the United States
* Prisoners
* Participants with hoarding as the primary OCD symptom
* Severe mental illness (e.g. schizophrenia, substance abuse); organic brain syndrome; or serious, current suicidal/homicidal ideation (based on phone screening or initial assessment)
* Concurrent enrollment in another psychotherapy treatment
* Participants taking psychotropic medication may be excluded if:

  * They have started a brand new psychotropic medication within the last 12 weeks
  * They have changed the dose of their psychotropic medication within the last 4 weeks
  * They anticipate that they cannot maintain the current dose of their psychotropic medication for the duration of the study
* Participants may be excluded if they have any cognitive or physical impairments that would interfere with their participation (e.g., significant head injury, cognitive disability, dementia).
Application of Point-of-care Ultrasound in Rapid Assessment of Cardiac Arrest Patients

To quickly assess the patient's cardiac function and structure through ultrasound

Monitor the peripheral arterial pulse and flow velocity, monitor the patient's lung and diaphragm muscle movement, monitor the patient's optic nerve sheath and cerebral blood flow, observe the morphology and blood flow of the liver and kidney and other parenchymal organs, Comprehensive evaluation of patient resuscitation quality.

For patients with cardiac arrest undergoing Cardio Pulmonary Resuscitation (CPR), the above monitoring was completed by ultrasound, and compared with the parameters obtained by end-expiratory carbon dioxide (ETCO2) and compression feedback device, to evaluate the feasibility of ultrasound to evaluate the quality of CPR. After the reliability evaluation was completed, parameters were further used to guide CPR quality improvement through ultrasound, end-expiratory carbon dioxide (ETCO2), and compression feedback device.

Eligibility Criteria:
Inclusion Criteria:

* Voluntarily participate and sign a written informed consent;
* Male or female above 18;
* Patients who are sent to the emergency room of our hospital with symptoms of "cardiopulmonary resuscitation";

Exclusion Criteria:

* There is trauma in the ultrasound examination site and it is not suitable for ultrasound examination;
* Entering the emergency room without vital signs for more than 30 minutes;
* The appearance of corpse corpses;
* There is life-threatening and irreversible damage;
* Other investigators consider it inappropriate and the patient or family member refuses;
Influence of Different Forms of Exercise Training in Patients With Coronary Artery Disease

The aim of the study is to compare the effect of water-based and land-based exercise training, and usual care (no exercise training) in patient with coronary artery disease, on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.

Swimming and other water-based physical activities represent an effective form of aerobic-dynamic exercise. However, existing guidelines mainly advise caution when recommending water-based activities to patients with coronary artery disease. To date, safety and efficacy of short-term water-based exercise in patients with coronary artery diseases have only scarcely been addressed.

Cardiovascular rehabilitation is an integral part of management after a myocardial infarction or coronary procedure. Most rehabilitation programs are exercise-based, since the beneficial effects of physical activity undisputed, and corroborated by a large body of evidence.

Most rehabilitation programs are exercise-based, since the beneficial effects of physical activity undisputed, and corroborated by a large body of evidence.

Research has mainly been focused on the impact assessment of the standard forms of physical training, they studied various forms of physical exercise, mainly land-based. No previous study has reported on the effect of exercise in water as an integral element of standard cardiac rehabilitation in coronary patients on exercise capacity, vascular function, arrhythmogenic potential and cardiac autonomic function, and markers of neurohormonal activity, activated hemostasis and inflammation.

Eligibility Criteria:
Inclusion Criteria:

* patients with coronary artery disease after myocardial infarction or myocardial revascularization (percutaneous coronary procedure or surgical revascularization)

Exclusion Criteria:

* unstable coronary artery disease, ejection fraction of the left ventricle of 40% or less, heart valve defect that dictate specific treatment, condition after valve replacement, heart rhythm disorders, the presence of a permanent pacemaker, contraindications to exercise, inability to perform exercise testing, mental retardation, severe anemia, obstructive/restrictive lung disease severe degree, recent thrombo embolic events, age over 80 years.
Estimating VO2 Max and Recovery

The study aims to estimate VO2 max levels at pre- and post-operative timepoints before and after hip arthroplasty surgery, using non-exercise-based measurement methods.

This observational cohort study will measure an estimation of VO2 max prior to and following routine robotic arm assisted hip arthroplasty surgery, and examine its association with outcomes of recovery after surgery. Although VO2 max is usually measured using cardiopulmonary exercise testing, these tests are often unachievable for an elderly population with end stage hip osteoarthritis and in a lot of pain. For this reason, this study will estimate VO2 max using the Seismofit® System. This works by measuring vibrations arising from heart beats that are transmitted to the chest. The small Seismofit® device is battery powered, and uses Bluetooth to communicate the results to a smartphone app. The device is simply attached to the lower part of the participant's sternum using an adhesive patch and takes around 45 seconds to record the data.

The study will also assess recovery through measuring pain and functional ability via patient reported outcome measures (PROMs) and objective performance assessments. In addition, participants will be invited to wear activity monitors on their wrist prior to surgery, and for 12 weeks after surgery, to understand changes in physical activity and sleep patterns.

Patients undergoing a robot-assisted hip arthroplasty with Professor Middleton at the Nuffield Health Hospital will be invited to take part in the study by the clinical team at Nuffield, and will be given a patient information sheet. If they are interested in taking part in the study, they will be contacted by a member of the research team at BU and invited into ORI to give their informed consent. Once the participant has consented, they will undergo pre-surgery assessments. It is anticipated that it will take 12 months to recruit the 30 participants. Participants will then have follow-up study visits on Day-1 at Nuffield Hospital, and at 3-, 6-, and 12-weeks post-surgery at ORI. Data relating to surgery, discharge and medication will also be taken from routine data collected at Nuffield Hospital. Participants will continue to be followed up clinically as per standard care at Nuffield Hospital. Findings from this feasibility study will inform the design of future interventions to improve cardiovascular fitness in patients undergoing hip arthroplasty surgery.

Eligibility Criteria:
Inclusion Criteria:

* Male and female ≥ 18 years;
* Undergoing total hip replacement at Nuffield Hospital;
* Voluntary written Informed Consent obtained;
* Participant able to complete study follow-up.

Exclusion Criteria:

* Requiring revision hip arthroplasty;
* Women judged by the Investigator to be of childbearing potential who are pregnant, nursing, or planning to become pregnant, and those who do not agree to remain on an acceptable method of birth control throughout the entire study period;
* Unable to provide informed consent (insufficient English, lives overseas, unable to return easily).
Quantifying and Developing Countermeasures for the Effect of Fatigue-Related Stressors on Automation Use and Trust During Robotic Supervisory Control

This project proposes to both develop and test adaptive automation countermeasures for the effects of stressors such as sleep deprivation (SD) on human performance related to robotic tasks, and investigate the relationship between human trust and appropriate use of these countermeasures.


Eligibility Criteria:
Inclusion Criteria:

* healthy by history, physical exam, laboratory evaluations of urine and blood, electrocardiogram (ECG), psychological screening, and self-reported sleep quality.
* engineering or computer programming experience

Exclusion Criteria:

* color blind
* pregnant or nursing
* using any prescription or non-prescription medications, caffeine, alcohol or tobacco for the three weeks prior to beginning the inpatient experiments
The Resistance Mechanism of Trastuzumab Deruxtexan in HER2 Positive Breast Cancer Patients.

This study is the spatial transcriptomic approach for revealing the resistance mechanism of trastuzumab deruxtexan in HER2 positive breast cancer patients.


Eligibility Criteria:
Inclusion Criteria:

* HER2 positive breast cancer
* Stage IV disease
* Treated with T-Dxd
* Available FFPE samples

Exclusion Criteria:

* TNBC breast cancer
* Hormone receptor positive breast cancer
* Non-available FFPE samples
* Treated except T-Dxd
Does Ultrasound Assessment for Extravascular Lung Water and IVC Measurement Affect Outcomes in Inpatient Heart Failure Management?

This study evaluates daily POCUS/FCU exams on patients admitted for acute decompensated heart failure with primary end point of acute kidney injury while in hospital.

Patients with admitted to hospital with Acute Decompensated Heart failure (ADHF) suffer a significant morbidity and premature mortality. Administration of intravenous (IV) diuretics is largely guided by clinical judgment based on physical exam, net fluid measurement, changes in daily weights and chest x-ray findings. The key objective is to promote adequate diuresis while improving symptoms, without compromising renal function. Laboratory tests demonstrating hemo-concentration, increasing BUN, and increasing creatinine have been proposed as positive prognostic indicators in patients receiving IV diuretic therapy but these methods suffer from inadequate predictive value. Observational studies have identified worsening renal failure (WRF) in patients admitted for heart failure as an important clinical entity associated with worsening clinical outcomes.

Point of care Ultrasound (POCUS) has the potential to fill an unmet need for monitoring patients recieving IV diuretic therapy. POCUS provides clinicians with immediate diagnostic information obtained and interpreted at bedside that can augment and enhance the physical examination. Numerous studies have examined POCUS assessment of pulmonary edema and measurement of the Inferior Vena Cava (IVC) to estimate hemodynamic parameters for patients with acute decompensated heart failure (ADHF). No study to date has examined POCUS effect on clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age \>18 admitted for acute decompensated heart failure exacerbation as primary admission diagnosis from Emergency department to General Medicine ward that are administered diuretic therapy expected to be admitted for two days or more.

Exclusion Criteria:

1. Decline consent for study
2. If admitted and research team not available for consent and initial evaluation prior within 6 hours of first diuretic administration
3. Patients in whom diuretics will not be utilized (i.e. anuric, ESRD on HD)
4. Inability to assess IVC (surgical anatomy, body habitus, Ileus, etc.)
5. Patients admitted to ICU
6. Patients currently on positive pressure ventilation (BiPAP)
7. Patients discharged from the emergency department
8. Patients discharged prior to evaluation by the POCUS team
Evaluation of [18F]FLT PET/CT as an Early Predictor of Outcome in Pediatric Solid Tumors

The experimental \[18F\]FLT-PET/CT will be completed before initiation of chemotherapy at either diagnosis or initiation of salvage chemotherapy at relapse and prior to the third cycle (or month) of chemotherapy. Laboratory analysis and correlative radiology, as directed per clinical care based on the primary diagnosis, are required within 30 days of the baseline \[18F\]FLT PET/CT. Follow-up will comprise 24 months of standard practice treatment and follow up.

Primary Objective is to assess if percentage change in \[18F\]FLT PET/CT quantitative parameters (SUV max, or SUV peak or proliferative tumor volume) after 2 cycles of chemotherapy can predict progression free survival at 1 and 2 years in pediatric patients with newly diagnosed or relapsed solid tumors.

Secondary Objectives are: (1) to assess if percentage change in \[18F\]FLT PET/CT quantitative parameters (SUV max, or SUV peak or proliferative tumor volume) after 2 cycles of chemotherapy can predict overall survival at 2 years in pediatric patients with newly diagnosed or relapsed solid tumors; and (2) for enrolled patients that undergo tumor resection as part of their therapy regimen within one month of the FLT imaging, mitotic index of the tumor will be assessed as compared to initial biopsy specimen and correlate with FLT activity.

Eligibility Criteria:
Inclusion Criteria:

* Patients with histologically confirmed solid tumor malignancies with residual tumors present that require standard of care chemotherapy for a minimum number of cycles. All anatomical sites and all tumor histologies are eligible including central nervous system tumors. Both newly diagnosed and/or newly relapsed patients are eligible.
* Patients ages 8 - 25 years
* In the opinion of the investigator, patients must be thought to be able to lie still for imaging without sedation for 20 - 30 minutes.
* Patients must have a performance status of \> 50% (Lansky or Karnofsky).
* Patients of childbearing potential must have a negative urine or serum pregnancy test as per institution's standard of care within 7 days prior to \[18F\]FLT PET/CT imaging.
* Ability to understand and the willingness to sign a written informed consent/assent.

Exclusion Criteria:

* Patients with known allergic or hypersensitivity reactions to previously administered radiopharmaceuticals of similar chemical or biologic composition to \[18F\]FLT
* Newly diagnosed subjects who had prior chemotherapy or radiotherapy before enrollment in the study. Relapsed patients are eligible prior to starting their relapsed chemotherapy regimen if they meet the other eligibility criteria.
* Subjects for whom chemotherapy is not a standard of care primary therapy option.
* Patients who are pregnant or breast-feeding.
* Patients with no residual tumor (i.e. complete resection at diagnosis or relapse).