cyrilzakka/clinical-trials huggingface dataset:
A Study of Relatlimab in Combination With Nivolumab in Participants With Advanced Liver Cancer Who Have Never Been Treated With Immuno-oncology Therapy After Prior Treatment With Tyrosine Kinase Inhibitors

The purpose of this study is to evaluate the effectiveness and safety of relatlimab in combination with nivolumab in participants with advanced liver cancer who have never been treated with immuno-oncology therapy, after prior treatment with tyrosine kinase inhibitor therapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Must have a diagnosis of hepatocellular carcinoma (HCC) based on histological confirmation
* Must have advanced/metastatic HCC
* Have to be immunotherapy treatment-naive in the advanced/metastatic setting
* Must have at least one Response Evaluation Criteria in Solid Tumors (RECIST) v1.1 measurable untreated lesion
* Child-Pugh score of 5 or 6
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 for ECOG performance status scale

Key Exclusion Criteria:

* Known fibrolamellar HCC, sarcomatoid HCC, combined hepatocellular cholangiocarcinoma
* Prior organ allograft or allogeneic bone marrow transplantation
* No uncontrolled or significant cardiovascular disease
* No active known autoimmune disease
* Have received one or two lines of tyrosine kinase inhibitor therapies
* Evidence of radiographic progression on or after the last line of tyrosine kinase inhibitor therapy

Other protocol-defined inclusion/exclusion criteria apply
ARDA Software for the Detection of mtmDR

This is a multicenter, observational study with primary endpoints to determine the sensitivity and specificity of two investigational software devices that detect the presence of more than mild diabetic retinopathy (mtmDR) in healthcare settings.


Eligibility Criteria:
Inclusion Criteria:

1. Documented diagnosis of Type I or Type II diabetes mellitus:

   meet the criteria established by either the World Health Organization (WHO) or the American Diabetes Association (ADA)
2. Age 22 or older
3. Understand the study and volunteer to sign the informed consent

Exclusion Criteria:

1. Self-reported visual symptoms and persistent blurred vision (greater than 24 hours); including vision loss that cannot be corrected (e.g. with eye glasses).
2. Diagnosed with macular edema, any known retinopathy, radiation retinopathy, or retinal vein occlusion.
3. History of laser treatment of the retina or injections into either eye, or any history of retinal surgery.
4. Scheduled to undergo the following surgeries before completion of the study imaging: cataract surgery (including any related follow-up procedures) or vitrectomy.
5. Currently participating in an interventional study.
6. Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure or glycemic control, microphthalmia or previous enucleation, etc.).
7. Participant is contraindicated for imaging by fundus imaging system used in the study; e.g.

   1. Participant is hypersensitive to light (side effect of medication or due to unknown etiology)
   2. Participant has undergone photodynamic therapy (PDT)
   3. Previous issues with dilation (angle closure, inability to dilate, allergy to dilation drops).
8. Known pregnancy or possibility of pregnancy
Randomized Controlled Trial of a Patient Activation Tool in Pediatric Appendicitis (Antibiotics Alone vs. Appendectomy)

The purpose of this study is to determine if a patient activation tool (PAT) can improve decision making and patient centered outcomes in pediatric patients with appendicitis and their caregivers choosing between antibiotics alone and appendectomy.

The objective of this study is to to determine if a patient activation tool (PAT) can improve decision making and patient centered outcomes in pediatric patients with appendicitis and their caregivers.

Hypothesis: A PAT that activates patient-caregiver dyads will improve decision making and patient centered outcomes without compromising medical outcomes in children with appendicitis. Specifically,the investigators expect the PAT to improve decision self-efficacy and healthcare satisfaction without increasing disability days.

Methods/Outcomes: The investigators will perform a randomized controlled trial comparing a PAT to standard surgical consultation in patient-caregiver dyads choosing between either antibiotics alone or appendectomy for early appendicitis. The investigators will identify differences in various components of decision making and patient centered outcomes including caregiver decision self-efficacy, preparedness for decision making, decisional conflict, decision regret, caregiver activation, caregiver and child satisfaction with care and health related quality of life (HRQOL), and caregiver and child knowledge. The investigators will also characterize the effects of a PAT on medical outcomes from appendicitis in patients receiving the PAT compared to those receiving standard surgical consultation alone. The investigators will determine differences in disability days, length of stay, readmission rates, and medical complications related to treatment choice (e.g. infection, recurrence).

Eligibility Criteria:
Inclusion Criteria:

* Age : 7-17 years
* Ultrasound (US) or Computed Tomography (CT) confirmed early appendicitis:

  * US: hyperemia, \<1.1 cm in diameter, compressible or non-compressible, no abscess, no fecalith, no phlegmon
  * CT: hyperemia, fat stranding, \<1.1 cm in diameter, no abscess, no fecalith, no phlegmon
* White Blood Cell count \< 18,000
* C-reactive Protein\<4 (if obtained)
* Focal abdominal pain \</= 48 hours prior to receiving antibiotics

Exclusion Criteria:

* Positive urine pregnancy test
* Other significant co-morbidities:

  * cardiovascular disease
  * malignancy
  * pulmonary disease
  * severe developmental delay
Assessment of the Effectiveness of IV and SC Abatacept (Orencia) Patient Alert Cards in Patients With Rheumatoid Arthritis in a Sample of EU Countries

The purpose of the study is to determine a) if the implementation of abatacept (Orencia®) patient alert card (PAC) resulted in effective understanding of key safety messages and b) if the degree of understanding of key safety messages is associated with improved clinical and safety outcomes.

3 sub studies: 2 Cross-Sectional and 1 retrospective chart review

Eligibility Criteria:
Inclusion Criteria:

* Patient survey (cohort 1):

  1. Patients has taken abatacept within the previous 3 months for rheumatoid arthritis
  2. Patient is 18 years of age or over
* HCP survey (cohort 2):

  a) Physician or nurses working in rheumatology centers, with at least 1 patient taking abatacept in the previous 6 months for rheumatoid arthritis (by prescribing, administering or by follow up)
* Retrospective chart review study (cohort 3):

  1. Patient survey questionnaire completed , Informed Consent Form (ICF) signed

Exclusion Criteria:

* Patient survey:

  1. Patient has participated in a clinical trial for their arthritis in the previous 12 months
  2. Currently an employee of BMS
* HCP survey:

  1. Physicians or nurse who have recruited patients for the Patient survey
  2. Currently an employee of BMS
Adjuvant Treatment for Incomplete Resection Thymoma or Thymic Carcinoma

This study is designed to investigate whether adjuvant radiochemotherapy after incomplete resection has a better survival than adjuvant radiotherapy for thymoma or thymic carcinoma.

The previous trials have showed that radiotherapy was significantly associated with prolonged OS and chemotherapy is playing an increasing role in treatment of patients with thymoma or thymic carcinoma.However,whether patients with thymoma or thymic carcinoma could benefit from adjuvant radiochemotherapy after incomplete resection remains controversial. The purpose of this study is to investigate whether adjuvant radiochemotherapy after incomplete resection can improve survival for thymoma or thymic carcinoma.

Eligibility Criteria:
Inclusion Criteria:

18\~75 years old; Eastern Cooperative Oncology Group performance status of 0 to 2; Pathologically confirmed ; incomplete resection (R1 or R2);have adequate bone marrow, hepatic, and renal function;Patients receive incomplete resection within 3 months; Written informed consent.

Exclusion Criteria:

Patients with distant metastases; Patients underwent radiotherapy or chemotherapy; Patients who have malignancy history excluding carcinoma in situ of cervix in the previous five years; Active clinical pulmonary infection; Pregnant or nursing.
Imaging Cerebral and Sub-cerebral Correlates of Meditative States

Three groups of subjects are trained to practice mindfulness meditation, compassion meditation, or attend a health training control class. Individuals from each group will undergo structural and functional brain imaging before and after training. The hypothesis is that the compassion meditation group will show the largest changes in brain structure and function. In a second series of experiments, the subjects practicing a Tibetan meditation practice will be undergo MRI thermometry imaging to construct detailed three dimensional temperature maps of their bodies before, during, and after they perform this practice.

Structural (MRI) Imaging will be used to measure changes in cortical thickness in the pre and post training groups. Function (fMRI) Imaging will be used to measure changes in cortical and sub-cortical responses to a series of affectively controlled visual images, presented during scanning. MRI Thermometry Imaging will be used to construct three dimensional temperature maps of subjects while performing meditation in the scanner.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-65 for the mindfulness-compassion study
* Prior training in gtummo meditation for the gtummo study

Exclusion Criteria:

* Previous experience with meditation for the mindfulness-compassion study
Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain

A randomized study evaluating the continued safety and efficacy of elagolix in the management of moderate to severe endometriosis associated pain in adult pre-menopausal women who completed 6 months treatment in pivotal Study M12-671 (NCT01931670).

The study consists of 2 periods: a 6 month Treatment Period and a post treatment follow-up period of up to 12 months.

Participants who received elagolix in the pivotal study who met all entry criteria continued to receive the same dose, either elagolix 150 mg once daily (QD) or elagolix 200 mg twice daily (BID) for up to an additional 6 months in this extension study; participants who received placebo in the pivotal study were randomized in a 1:1 ratio to receive either elagolix 150 mg QD or elagolix 200 mg BID for up to 6 months.

An electronic diary will be used to collect endometriosis-associated pain, uterine bleeding, and analgesic medication use for endometriosis associated pain on a daily basis.

Eligibility Criteria:
Inclusion Criteria:

* Subject has completed the 6-Month Treatment Period in pivotal study M12-671.
* Agrees to use required birth control methods during the study through Month 6 of the Post-treatment Follow-up period

Exclusion Criteria:

* Clinically significant gynecological condition
* Bone mineral density (BMD) loss greater than or equal to 8 percent in the spine, femoral neck or total hip
* Plans to become pregnant in the next 18 months
Role of Exposure in Hyperacusis

This study focuses on patients with a primary complaint of hyperacusis. Hyperacusis has been defined as 'abnormally reduced tolerance to sound'. It shows a high comorbidity with tinnitus, the perception of sound in the absence of a sound source. For the period of one month, hyperacusis and tinnitus severity and exposure to sounds will be evaluated by use of Ecological Momentary Assessment (EMA) in all participants. A novel approach to assessments, EMA prompts participants during their daily life to answer short questionnaires, increasing ecological validity and minimizing the risk for recall and memory biases. At a randomized time point during the one-month period, participants will individually receive a single psychoeducation session (1h) delivered by an experienced audiologist. The goal of the study is to investigate if the psychoeducation session leads to an increase in exposure to sound and a decrease in hyperacusis severity.


Eligibility Criteria:
Inclusion Criteria:

* primary complaint of hyperacusis

Exclusion Criteria:

* primary complaint of misophonia
* primary complaint of tinnitus
* undergoing another therapy at the moment of the study
Thermal Imaging in Neonates: A Feasibility Study in Healthy Babies and Babies With Suspected TTN

This is a study to evaluate thermal imaging as a technology to monitor the normal clearing of amniotic fluid from healthy newborns and newborns suspected of having a condition called transient tachypnea of the newborn, or TTN. Thermal images are taken using an imaging device that attaches to an iPhone. This device, commercially known as FLIR ONE, creates a non-identifiable image based on the heat pattern of an object. In this case, the object is a child's chest and back. It does not emit any radiation like an x-ray does.


Eligibility Criteria:
Inclusion Criteria (healthy and suspected TTN babies):

* Full term (greater than or equal to 37 weeks gestation)
* less than 3 days old
* born via normal vaginal delivery

Inclusion Criteria (only for suspected TTN babies):

* neonatologist assesses baby as possibly having TTN
* chest x-ray done as part of evaluation for TTN
* no other significant co-morbid conditions present

Exclusion Criteria:

* parents do not consent to have baby participate
The Impact of a Physical Activity Program on Biomarkers of Aging During Chemotherapy for Breast Cancer

This study will look at whether or not participating in a physical activity intervention during chemotherapy for breast cancer can prevent a marker of aging called p16 from having a large increase after chemotherapy.

Our research team has determined that p16INK4a - a biomarker of aging -- increases dramatically during chemotherapy and that p16 levels among patients of similar age are lower among those who exercise. We hypothesize that engagement in physical activity during chemotherapy will have a moderating effect on increases in p16 levels during chemotherapy. To test this hypothesis, we propose to enroll 48 patients age 21-64 with a Stage I-III breast cancer diagnosis who are about to start adjuvant or neoadjuvant chemotherapy in a physical activity intervention program. Our primary objective is to compare the change in p16 from baseline to end of chemotherapy for participants in this study (who are engaged in a physical activity intervention) to the mean change in p16 seen in a previous study of similar patients who did not participate in a physical activity intervention. As secondary objectives, we propose to evaluate (1) changes in treatment-related toxicity, physical function, fatigue, and quality of life between baseline, end of chemotherapy and 6 months post-chemotherapy, (2) the association of changes in p16 levels with changes in measures of treatment-related toxicity, physical function, fatigue, and quality of life, and (3) the association of changes in physical activity levels with changes in measures of treatment-related toxicity, physical function, fatigue, and quality of life.

Eligibility Criteria:
Inclusion Criteria:

* 21 to 59 years of age, female (A similar trial LCCC 1226 explores physical activity in women 60 years and older and is now in progress.
* Histologically confirmed Stage I, II or III breast cancer (if the patient has had more than one breast cancer, then the most recent diagnosis)
* Scheduled to begin an appropriate adjuvant or neo-adjuvant chemotherapy regimen as defined by NCCN guidelines (www.nccn.org). Patients receiving anti-HER-2 therapy are eligible but the intervention will only be tested during the chemotherapy portion of the regimen.
* English speaking
* IRB approved, signed written informed consent
* Approval from their treating physician to engage in moderate-intensity physical activity
* Patient-assessed ability to walk and engage in moderate physical activity
* Willing and able to meet all study requirements.

Exclusion Criteria:

* One or more significant medical conditions that in the physician's judgment preclude participation in the walking or strength training intervention.
* Unable to walk or engage in moderate-intensity physical activity.
Using Tailored Messages to Encourage Healthy Lifestyle Choices in a Brief, Self-directed Intervention

The study aimed to investigate 1) if a brief, regulatory focus-based intervention could promote weight control and changes in certain lifestyle behaviors and 2) how weight was affected by changes in these behaviors. The lifestyle behaviors of interest included meal regularity, self-monitoring of diet and physical activity, fast-food eating, screen related viewing and eating, dietary modifications, self-weighing, and physical activity. It was hypothesized that increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity would lead to better weight control over six months. Conversely, it was hypothesized that increases in fast food consumption and screen related eating and viewing would lead to poorer weight control over six months. It was expected that promotion and prevention conditions, relative to the control condition, would lead to better weight control and increases in meal regularity, self-monitoring, healthy dietary modifications, self-weighing, and physical activity, and decreases in fast food consumption and screen related eating and viewing. Furthermore, it was expected that the promotion condition would lead to better outcomes than the prevention condition.


Eligibility Criteria:
Inclusion Criteria:

* 18+ years old
* generally healthy
* BMI between 18.5 and 35

Exclusion Criteria:

* pregnancy within the past 6 months
* current pregnancy
* plan to get pregnant in the next 6 months
* serious physical or psychological problems that would contraindicate participation in a weight-related program
* history of anorexia or bulimia
* diabetes or hypertension
* current participation in a weight-loss program
* BMI \< 18.5, \>35.0
Arthroscopic Rotator Cuff Repair Augmented With Platelet Rich Plasma

Purpose: To assess whether the use of platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair. Hypothesis: Platelet rich plasma used as an adjuvant to arthroscopic rotator cuff repairs decrease the rate of retears.

Platelet-rich plasma used as an adjuvant to arthroscopic rotator cuff repairs modify the rate of re-tears (measured by MRI) compared to a control group that only underwent the isolated arthroscopic repair.

Eligibility Criteria:
Inclusion Criteria:

* Adults between 50 and 75 years with a defined complete rotator cuff tear as compatible clinical and confirmation by magnetic resonance imaging (MRI).
* Minimum of 3 months of failed conservative treatment (anti-inflammatory, physical therapy and infiltration with corticosteroids)

Exclusion Criteria:

* Refusal to participate or informed consent,
* Revision surgery,
* Partial repair,
* Patients with shoulder osteoarthritis\> 2
* Advanced fat infiltration of the rotator cuff muscles (STAGE 3 or 4)
* Systemic or rheumatoid arthritis,
* Uncontrolled diabetes, (patients for whom surgery is contraindicated in the preoperative evaluation by the clinician and anesthesiologist)
* Acute or chronic infections of the shoulder to be operated on
* Ongoing cancer chemotherapy therapies
* Sepsis, septic arthritis, osteomyelitis or other ongoing infectious processes;
* Previous operations on the affected shoulder,
* Patients with autoimmune diseases;
* Pregnant
Value of PET/CT Imaging in the Diagnosis of Permanent Central Venous Catheters Infection

The study hypothesis is that F-18-FDG PET/CT and microcalorimetry might have a diagnostic value in the detection of permanent central venous catheters (PCVC) infection when conventional means of PCVC infection detection are non-conclusive.

Permanent central venous catheters are frequently infected and therefore need surgical removal. When a clear diagnostic for infection cannot be defined, catheter removal might be at risk for the patient, for the therapeutic follow-up and in terms of costs. PET/CT and microcalorimetry might help giving conclusive diagnostic of catheter infection.

Eligibility Criteria:
Inclusion Criteria:

* patients with confirmed catheter infection requiring surgical removal
* patients with probable catheter infection requiring surgical removal
* patients with planned removal of uninfected catheter
* ≥18years old

Exclusion Criteria:

* extreme claustrophobia
* pregnancy and breastfeeding
* severe septicemia
Five Versus Seven Day Antibiotic Course for the Treatment of Pneumonia in the Intensive Care Unit

The goal of the study is to determine if patients who are being treated for pneumonia in the intensive care unit can be safely treated with five days of antibiotics (the current standard is seven to eight days). The goal is to determine if the investigators can minimize antibiotic complications while still treating the infection. Patients in the study are randomly assigned to either receive antibiotics for a goal of five days or a goal of seven days. Every patient is followed daily, and if they are not responding to the antibiotics, the treating team in the intensive care unit care can continue the antibiotics for a longer course regardless of what group the patient is assigned. The investigator's hypothesis is that patients in the five day treatment goal will be able to receive less antibiotics than patients in the seven day treatment goal without any adverse effects.

This is a pilot study to determine if patients with pneumonia in the intensive care unit can safely receive five days of antibiotics. All patients admitted to the medical and surgical intensive care units at Barnes-Jewish Hospital with pneumonia will be screened for the inclusion and exclusion criteria. Patients will be randomized by sealed envelopes in groups of six to a five or seven day course of antibiotics. The choice of the antibiotic to be used is determined by the intensive care unit treating team. The patients will NOT be randomized to a specific antibiotic. The patients will be followed for a clinical response by improvement in maximum daily temperature, white blood cell count, and PaO2 to FiO2 ratio. Antibiotics can continue past the goal duration for patients in either group if the above criteria are not met or if the attending physician in the intensive care unit feels that a longer course is needed. The treating team in the intensive care unit will not be blinded to the patient's treatment assignment.

Eligibility Criteria:
Inclusion Criteria:

* New diagnosis of pneumonia
* Patient in medical or surgical intensive care unit
* Age greater or equal than 18 years old

Exclusion Criteria:

* Neutropenia
* Recipient of a solid organ or bone marrow transplant
* Bacteremia
* Presence of Acinetobacter baumannii or Stenotrophomonas maltophilia from a respiratory tract culture
* Presence of a second infection requiring antibiotic therapy
* Pregnancy
* Enrollment in another clinical study
* Patient or surrogate unable to provide informed consent
* Attending intensive care unit physician declined enrollment in the study