cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess Safety and Effectiveness of Injections of NOA VOLUME Injectable Gel in Adult Participants Compared to JUVÉDERM VOLUMA XC for Change of Mid-Face Volume

Facial fullness is often regarded as a characteristic feature of a youthful face. Chronic reduction of collagen, elastin, and glycosaminoglycans contribute to the facial volume loss that characterizes the aging face. Volume restoration by replacing or augmenting soft tissue is critical to successful facial rejuvenation. NOA VOLUME is a crosslinked Hyaluronic Acid (HA) gel implant formulated with lidocaine that was developed to provide a safe, minimally invasive method of improving mid-face volume deficit. The purpose of this study is to assess safety and effectiveness of NOA VOLUME in adult participants seeking improvement of mid-face volume compared to JUVÉDERM VOLUMA XC (VOLUMA XC).

NOA VOLUME is an investigational device being developed for the improvement of mid-face volume. There will be 2 cohorts in this study. In Cohort 1, participants will receive either NOA VOLUME or VOLUMA XC with a fixed follow-up period. In Cohort 2, participants will receive either NOA VOLUME or VOLUMA XC with a variable follow-up period. Around 231 adult participants seeking improvement of mid-face volume will be enrolled in the study at approximately 15 sites in the United States.

Participants will receive either NOA VOLUME or VOLUMA XC as subcutaneous and/or supraperiosteal plane injections in the cheek on Day 1. Participants will receive optional touch-up treatment at Day 31 and optional repeat treatment at Month 18 for Cohort 1 and at Month 12, 15, or 18 for Cohort 2 and will be followed up for up to 22 months.


Eligibility Criteria:
Inclusion Criteria:

* Has moderate (3), significant (4), or severe (5) mid-face volume deficit on the 5-point photonumeric MFVDS based on evaluating investigator's (EI) live assessment.
* Mid-face is amenable to achieving at least a 1-point improvement in MFVDS score with the allowed injection volume in the treating investigator's (TI) judgement.

Exclusion Criteria:

* Significant skin laxity in the midface in the opinion of the TI.
* Significant skin pigmentation disorders or discoloration in the mid-face area that would interfere with the visual assessment of the mid-face area.
* Current cutaneous inflammatory or infectious processes (e.g., acne, herpes), abscess, unhealed wound, or cancerous or precancerous lesion on the face.
Efficacy of the Cognitive Training Based on Location Information and Activity in People With Mild Cognitive Impairment

The purpose of this study is to examine therapeutic efficacy of cognitive Training based on location information and activity in people with mild cognitive impairment

* A single arm, open-label study.
* Cognitive Training based on location information and activity is consists of both cognitive training and exercise(walking) using objects in the participant's home. The researchers visit the participant's home and find objects that were mainly used in the real life and easy to access (table, computer, television, etc.) and attach the recognition Bluetooth Low Energy(BLE) Tag (sticker integrated). The stickers printed on the tags consist of word categories (eg animals) belonging to a particular category, so as to assist strategic recall in the stepped recall task. The participants follow the instruction from the tablet-based program to perform the task. During performing the cognitive training program, the participants are guided to walk between the tagged objects in their home.
* The participants are aged over 60 years old and diagnosed with mild cognitive impairment.

Eligibility Criteria:
Inclusion Criteria:

* Aged above 60
* Confirmed literacy o Diagnosed with mild cognitive impairment by International Working Group on Mild Cognitive Impairment and Clinical Dementia Rating(CDR) of 0 or 0.5.

Exclusion Criteria:

* Evidence of delirium, confusion
* Any neurological conditions causing cognitive decline such as Parkinson's disease, brain hemorrhage, brain tumor, normal pressure hydrocephalus
* Evidence of severe cerebrovascular pathology
* Presence of depressive symptoms that could influence cognitive function
* Presence of medical comorbidities that could result in any difficulties in study participation
Metta Meditation Training on Prosocial Behavior

The purpose of the study is to look at the impact of a metta meditation training on prosocial behavior and socio-affective brain responses. The training involves an 8-week, online administration of guided metta meditation practices aimed at generating feelings of kindness and compassion for other people. The study examines how participants respond to thinking about familiar others and strangers using behavioral and brain-imaging measures. This study will be important for understanding how people develop the capacity to be prosocial towards other individuals, which is a key component of adaptive social behavior.


Eligibility Criteria:
Inclusion Criteria:

* Is a medically healthy individual
* Lives in the Washington, D.C. metro area and is able to travel to Georgetown University

Exclusion Criteria:

* Has experience with meditation
* Has any MRI contraindication (e.g. metal in the body, cardiac pacemaker, cannot lie still, etc.)
* Has any neurological disease
* Has a current psychiatric disorder
* Is pregnant or planning to become pregnant
* Is on medication that affects the central nervous system (e.g. psychotropic drugs)
Healthful Seafood Consumption for Sensitive Populations

Fish can provide pregnant women with omega-3 fatty acids for fetal brain development but some fish contains high levels of mercury which is detrimental to fetal brain development. The hypothesis is that women who have previously consumed high mercury fish can reduce the mercury level in their bodies and improve their omega-3 levels in three months by eating fish that is high in omega-3 fatty acids and low in mercury.

Exposure to methylmercury, a developmental toxicant found primarily in fish. Fish is nutritionally important for providing long chain omega-3 fatty acids that are important for perinatal health. Since maternal transfer of mercury and omega-3 fatty acids are the primary routes for fetal (placental transfer) or infant (maternal milk) exposure, there is a critical need to develop specific advice for childbearing-aged women based upon the 2004 Dietary Guidelines Advisory Committee's recommended intake i.e., consume 8 ounces of fish per week. This clinical trial investigates whether weekly consumption of selected fish species for 12 weeks can improve plasma concentrations of the omega-3 fatty acids (eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)) while reducing hair or blood mercury concentrations.

Eligibility Criteria:
Inclusion Criteria:

* Hair mercury levels equal to or greater than 0.8 ppm

Exclusion Criteria:

* Pregnant or planning to become pregnant in the next 3 months
* Nursing
Effect of Two Exercise Programs on Bone Strength and Architecture

Bone responds according to the load placed on it. In this study, investigators want to know if exercise that loads the body in exercises, like walking or jogging (Ground Reaction Forces: GRF), affects bone differently than exercises that load the joints, like weight lifting (Joint Reaction Forces: JRF). Participants will exercise at least 3 times a week for 6 months. Measures of bone strength and mass, muscular strength, and aerobic fitness will be taken at the beginning and the end of the 6 month program. Period blood samples will be taken for future analysis of blood markers.


Eligibility Criteria:
Inclusion Criteria:

* non-smoker
* in generally good health
* not physically active (less than 60 minutes of purposeful exercise/week)
* able to travel to the exercise facility a minimum of 3 times/week

Exclusion Criteria:

* use of glucocorticoids
* abnormal resting EKG
* angina and/or evidence of acute myocardial ischemia during a treadmill test
* resting blood pressure above 150 mmHg systolic of 90 mmHg diastolic
* anti-resorptive drug use in the last 2 years
* initiation of treatments that could impact bone metabolism (diuretics, hormones, bine anabolic agents) in the prior 6 months
* dual-energy x-ray absorptiometry (DXA) t-score \<+ -2.5 at the femoral neck and/or lumbar spine
* serum vitamin D concentration \<20 ng/mL
* uncontrolled thyroid disease
* any contraindications to regular exercise
A Study to Learn About the Study Medicine (Called Avelumab) in People With Advanced Urothelial Cancer After Chemotherapy

The purpose of this clinical trial is to learn about the safety and effects of the study medicine (called Avelumab) in people with advanced urothelial (bladder) cancer (UC) whose disease hasn't worsened after receiving chemotherapy.

This study is seeking participants who:

1. Have UC that cannot be operated on or has spread to other parts of the body
2. Received 1st line platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
3. Received Avelumab as indicated as the only therapy for the first-line maintenance who are progression-free following platinum-based chemotherapy
4. Are 18 years or older on the date that they start taking Avelumab

All participants in this study will receive Avelumab, a standard treatment for urothelial carcinoma. Participants will take part in this study for about 4 years. During this time, they will take Avelumab as instructed in the real-world setting. We will study the experiences of people receiving the study medicine. This will help us decide if the study medicine is safe and effective.

The primary objective of this study is to estimate real-world overall survival (rwOS) in a real-world cohort of patients treated with avelumab monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy.

The secondary objectives are:

1. To describe the clinical and demographic characteristics of the study population
2. To estimate real-world progression-free survival (rwPFS)
3. To describe treatment characteristics of 1L anti-cancer therapies received prior to the initiation of avelumab as 1Lmaintenance therapy
4. To describe treatment patterns after initiation of avelumab as 1L maintenance therapy
5. To describe the adverse events (AEs) explicitly attributed to avelumab in a real-world population
6. To describe real-world all-cause associated healthcare resource burden associated with avelumab therapy

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a diagnosis of locally advanced or metastatic UC, either de novo or relapsed
2. Patients received 1L platinum-based chemotherapy and had stable disease, partial response, or complete response to this treatment
3. Patients received avelumab as indicated as a monotherapy for the first-line maintenance treatment of adult patients with locally advanced or metastatic UC who are progression-free following platinum-based chemotherapy
4. Patients aged ≥18 years on the date that they commenced avelumab -

Exclusion Criteria:

1. Patients whose hospital records are not available for review
2. Patients who are receiving an investigational medicinal product as part of a clinical trial at the time of maintenance therapy with avelumab
Insulin Glargine Plus Insulin Glulisine Multiple Daily Injections (MDI) Versus Premix Insulin Treatment in Subjects With Diabetes Mellitus (Type 1 or Type 2)

The purpose of this study is to test for superiority in improvements from baseline in patient reported outcomes in subjects with type 1 or type 2 diabetes when treated with insulin glargine plus rapid acting insulin glulisine MDI versus treatment with premix insulin.


Eligibility Criteria:
Inclusion Criteria:

* Informed consent in writing at enrollment
* Subjects with type 1 or type 2 diabetes mellitus for at least six months
* Male or female 21 - 70 years of age
* Employed, unpaid work or active lifestyle
* Screening hemoglobin A1c (HbA1c) level of ≥ 7.0 and ≤ 9.0 %
* Current (last 3 months) daily use of premix insulin 75/25, 70/30, or isophane insulin (NPH) or Lantus with short acting insulin, consisting of 2 or more injections per day with or without concomitant therapy consisting of metformin, thiazolidinedione, and/or alpha-glucosidase inhibitors.
* Willing and able to inject insulin glargine and multi-day dosing of insulin glulisine.
* Willing and able to perform self-monitoring of blood glucose (SMBG) four times a day and continuous glucose monitoring (CGMS) for 48 hours at three time periods during the study
* Willing and able to use adequate contraception if of child bearing age
* Able to read and understand English (at the sixth grade level) and comply with the study protocol

Exclusion Criteria:

* Cardiac status New York Heart Association (NYHA) III-IV
* Serum creatinine ≥ 1.5 mg/dl for males, or ≥ 1.4 mg/dl for females.
* Clinical evidence of active liver disease or serum ALT or AST \> 2.5 times the upper limit of normal range.
* Subjects currently using an insulin pump
* Subjects currently taking sulfonylureas, repaglinide, nateglinide, symlin (pramlintide acetate) or byetta (exenatide).
* Planned pregnancy in next 6 months or pregnant or lactating females
* Diagnosis of dementia or mental condition rendering the subject unable to understand the nature, scope and possible consequences of the study
* Unable to obtain complete CGMS data prior to baseline, visit 2 (week 0)
* Hypersensitivity to insulin glargine or insulin glulisine or premix insulin or any of their components
* Any disease or condition (including abuse of illicit drugs, prescription medicines or alcohol) that in the opinion of the investigator or sponsor may interfere with the study compliance and completion of the study.
* Treatment with intermittent doses of systemic steroids or intermittent large doses of inhaled steroids for the past one year (treatment with fixed doses for the past 6 months is acceptable providing there is no plan to change the dosage regimen)
* Treatment with any investigational product in the last 3 months before study entry
* Stroke, myocardial infarction (MI), coronary artery bypass graft (CABG), percutaneous transluminal coronary angioplasty (PTCA), or unstable angina pectoris within the last 12 months
* Current malignancy, any previous breast cancer, any previous malignant melanoma or any cancer within the past 5 years (except adequately treated basal cell skin cancer)
Stakeholder Assessment of Implementing the Commission on Cancer Operative Standards for Cancer Surgery

This study investigates the barriers to implementing breast Synoptic Operative Reports. Information from this study may help researchers identify performance objectives for the breast Synoptic Operative Reports to be adopted, implemented and continued.

PRIMARY OBJECTIVES:

I. To identify and describe barriers to implementing breast Synoptic Operative Reports (SOR) from multiple constructs.

Ia. Identify performance objectives - who must do what - for the breast SOR to be adopted, implemented, and continued.

OUTLINE:

Participants participate in interview over 30-60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>= 18 years
* Available phone or device for contact
* English speaking
* Works at Commission on Cancer (CoC) - accredited cancer program

Exclusion Criteria: none
Myeloperoxidase (MPO) Inhibitor A_Zeneca for Heart Failure With Preserved Ejection Fraction (HFpEF)

Researchers are studying the effect of a single dose of oral myeloperoxidase on heart failure versus placebo.

Enroll subjects with a normal ejection fraction referred to the catheterization laboratory for evaluation of breathlessness or shortness of breath. Perform safety lab sampling, echocardiography, arterial tonometry for pulse wave analysis, and assessment of endothelial function prior to administration of study drug. During the catheterization researchers will perform blood draws, assess baseline exercise capacity at rest and during exercise. Researchers will also do an echocardiogram to take measurements of the heart. Subjects will be randomized to one of two groups, Oral Myeloperoxidase Inhibitor or placebo group. Study drug or placebo will be administered followed by a repeat of the baseline catheterization assessments. At the conclusion of the second exercise test the subject will be moved to a room and monitored overnight for safety. Repeat blood draws, echocardiogram, endothelial function test, and heart monitoring will be completed. The subject will be asked to follow up with the researchers between 9-14 days after the study drug dosage. The subjects history and blood work will be completed at that visit.

Eligibility Criteria:
Inclusion Criteria:

1. Males and females of non-childbearing potential
2. Age ≥ 30 years
3. Symptoms of dyspnea (II-IV) at the time of screening
4. Ejection Fraction (EF) ≥ 50% as determined on imaging study within 12 months of enrollment
5. Catheterization documented elevated filling pressures at rest (PCWP ≥15) or with exercise (PCWP ≥25)

Exclusion Criteria:

1. Use of nitrates, phosphodiesterase 5 inhibitors or other NO-providing therapy in the past 24 hours of screening
2. Significant valvular disease (\>moderate left-sided regurgitation, \>mild stenosis)
3. Requirement of intravenous heparin at the start of case
4. Severe pulmonary parenchymal disease
5. Acute coronary syndrome or coronary disease requiring revascularization in the judgement of investigators
6. Resting systolic blood pressure \< 100 mmHg
7. Constrictive pericarditis
8. Infiltrative, restrictive, or hypertrophic obstructive cardiomyopathies
9. Previous anaphylaxis to any drug
10. Pregnancy or breastfeeding mothers
11. High Output heart failure
12. Active thyroid disease
13. Treatment with a new chemical entity (defined as a compound which has not been approved for marketing) within the preceding 3 months
14. Patients with any prior allergy to propylthiouracil
Operation ACL: Rehabilitation After Anterior Cruciate Ligament Reconstruction

Scientific Research Question

Overall Purpose:

Regarding rehabilitation after anterior cruciate ligament reconstruction (ACLR), there is a knowledge gap - a lack of evidence. Important questions such as how rehabilitation should be structured, what it should include, and how it should be evaluated are currently not clear. Therefore, the investigators plan to conduct a two-year follow-up randomized controlled trial (RCT) on post-ACLR rehabilitation.

Moreover, detailed information on how/under what circumstances the ACL injury occurred is not satisfactorily described in the literature. Therefore, the investigators are planning a new survey that can identify, explain, and prevent the risk factors causing a person to suffer from an anterior cruciate ligament injury.

Specific Objectives:

How should guidelines for rehabilitation after ACLR be structured, what should they include, and how should they be evaluated to best restore knee function in the patient? Can a detailed and comprehensive survey identify, explain, and prevent the risk factors causing a person to suffer from an ACL injury?

The overall aim of the project is to improve the physiotherapeutic guidelines to enhance the quality of rehabilitation for patients with surgically repaired anterior cruciate ligament (ACL) injuries. ACL injury is a severe knee injury that often prevents young individuals from continuing sports activities at their desired level. It can eventually lead to knee osteoarthritis within 10-15 years after the initial injury. Despite existing research on preventive training for young athletes in high-risk sports such as soccer, handball, and floorball, this injury remains common. ACL injury in young female athletes engaged in contact sports is 2-5 times more prevalent compared to young males. Regarding rehabilitation after ACL reconstruction, literature often indicates inadequacies where full muscle strength or jumping ability has not been regained. Despite this, patients often return to sports activities, which may increase the risk of re-injury. Guidelines for structuring rehabilitation, its content, and evaluation need improvement accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Athletes or recreational athletes that have undergone ACLR

Exclusion Criteria:

* Patients that have undergone ACLR that are nor athletes or recreational athletes
Trifocal Intraocular Lens (IOL) Aberrometry Outcomes

The goal of this study is to evaluate subject outcomes and spectacle independence with intraoperative aberrometry and trifocal IOL implantation.


Eligibility Criteria:
Inclusion Criteria:

* Able to consent to study and cataract surgery
* Visually significant cataract
* Potential post-operative visual acuity of 20/25 or better
* Age 18 years or older

Exclusion Criteria:

* Ocular pathology contraindicated for trifocal IOLs including but not limited to diabetic retinopathy, age-related macular degeneration or other macular pathology, cornea guttata, corneal scarring, corneal ectasia, glaucoma with visual field loss
* Irregular astigmatism
* Prior corneal refractive surgery
IL13Rα2 CAR-T for Patients With r/r Glioma

This is a dose exploration clinical trial to assess the safety and feasibility of the IL13Ra2-targeted CAR-T in glioma.

Interleukin 13 receptor subunit alpha-2 (IL13Ra2A) is a high-affinity membrane receptor of the anti-inflammatory Th2 cytokine IL13, which is overexpressed in glioma and correlated with poor prognosis.

Chimeric antigen receptor (CAR) T cell therapy is a promising treatment approach for many malignancies. IL13Ra2-targeted CAR-T cells are under investigation in several clinical trials in primary CNS malignancies.

The investigators now designed a new structure CAR targeted IL13Ra2, and initiated a single arm, open, dose exploration clinical trial to evaluate the safety, tolerability, clinical efficacy, and pharmacokinetic characteristics of IL13Rα2 CAR-T for patients with glioma. This clinical trial will enroll 12-30 cases of patients with IL13α2-positive recurrent or refractory WHO grade 4 glioma (r/r WHO4 glioma), aiming to find the maximum tolerable dose (MTD), the recommended phase 2 dose (RP2D) and preliminary efficacy of the new structure IL13Ra2 CAR-T.

Eligibility Criteria:
Inclusion criteria:

1. Male or female aged 18-75 years (including 18 and 75 years old).
2. Karnofsky scale score (KPS)≥50.
3. Subjects with WHO grade 4 gliomas who have relapsed or progressed during or after standard treatments such as surgery, radiotherapy, and chemotherapy.
4. Tumor with IL13Rα2 positive expression.
5. Availability in collecting peripheral blood mononuclear cells (PBMCs).
6. Adequate laboratory values and adequate organ function.
7. Patients with childbearing/fathering potential must agree to use highly effective contraception.

Exclusion criteria:

1. Pregnant or breastfeeding females.
2. Contraindication to bevacizumab.
3. Within 5 days prior to the infusion of CAR-T cells, subjects receiving systemic administration of steroids with dosage more than 10mg/d prednisone or the equivalent doses of other steroids (not including inhaled corticosteroid).
4. Comorbid with other uncontrolled malignancy.
5. Active immunodeficiency virus (HIV) or hepatitis B virus or hepatitis C virus or tuberculosis infection.
6. Autoimmune diseases.
7. Severe or uncontrolled psychiatric diseases or condition that could increase adverse events or interfere the evaluation of outcomes.
8. Subjects who have previously received cell therapy (such as TCR-T, CAR-T, TIL, etc.).
9. Subjects with other conditions that would interfere trial participation at the investigator's discretion.