cyrilzakka/clinical-trials huggingface dataset:
DC Vaccines Targeting HPV16/18 E6/E7 Protein to Regress CINI/CIN2

To establish therapeutic dendritic cell (DC) vaccines targeting HPV 16/18 E6/E7 protein to block the progression of CIN1/CIN2 to cervical cancer and evaluate the safety and efficacy of the vaccines.

Cervical cancer is the second most common cause of cancer-related deaths among women worldwide with 10000 new cases each year in China. The high-risk human papillomavirus (HPV) was the major cause of cervical cancer. The oncoproteins E6 and E7 encoded by HPV16 and 18, are consistently expressed in HPV-associated Cervical cancer and are responsible for the cervical cancer malignant progression. Targeting the E6/E7 proteins could be very helpful to regress the CIN 1/2 and block the tumorigenesis.

By this research, we aim to establish the HPV16/18 E6/E7 peptide library which could induce the strong anti-virus immune response and to vaccinate the CIN 1/2 patients with dendritic cell vaccines loaded HPV 16/18 E6/E7 epitopes.

Including:

1. To create an effective HPV 16/18 E6/E7 antigen peptide library using NetMHCspan software based on the MHC-I subtype of the Chinese population and screen E6/E7protein peptides with high binding affinity to MHC molecules;
2. To develop HPV 16/18 E6/E7- pulsed DC vaccines and evaluate the safety and efficacy of DC vaccines;
3. The patients are vaccinated with the HPV16/18 E6/E7- pulsed DC vaccines
4. To evaluate the safety and efficacy of DC vaccines loaded with HPV 16/18 E6/E7.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years ≤ 70 years at the time of informed consent
2. HPV type 16/18 positive
3. Pathologically confirmed CIN1/2 and no other cervical disease
4. adequate organ functions.

Exclusion Criteria:

1. Severe allergy to drugs
2. Women of child-bearing potential who are pregnant or breast-feeding
3. Any form of primary immunodeficiency
4. With serious cardiac, cerebrovascular and primary diseases
5. With a history of severe mental illness
Brain Mechanisms Underlying the Effect of the Motilin Receptor Agonist Erythromycin on Hunger in Normal Weight Subjects

The purpose of this study is to investigate the role of erythromycin, a prokinetic agent, on hunger, and the brain mechanism lying behind it.


Eligibility Criteria:
Inclusion Criteria:

* Female only.
* Age \> 18 and \< 60.
* Body Mass Index (BMI) of 19-25 kg/m2 (no weight change of more than 5 kg in the past three months).
* Not known to have any chronic medical illness or illnesses affecting the gastrointestinal, cardiovascular, or nervous systems, chronic pain or psychiatric disorder.
* If female not known to be pregnant.
* Not known to have any past upper gastrointestinal surgery.

Exclusion Criteria:

* Alcohol consumption \> 7 drinks / week
* Major depression and chronic health conditions except controlled hypertension
Use of a Novel Fibrin Sealant in Total Knee Arthroplasty

Applying a fibrin spray, after knee device implantation, will help in reducing patient blood loss and decrease the drop in both hemoglobin and hematocrit levels. Also, with decreased blood loss there should be a reduced need for blood transfusions.

Study Design

Study design and control methods:

This study is designed as a prospective, randomized, double-blinded controlled clinical trial to compare the effect of a fibrin spray applied to the surgical wound as compared to patients not receiving the fibrin spray.

Treatment group:

The subjects will be randomly assigned to the fibrin treatment group or to the control group at the time of the surgery via the opening of a randomly selected sealed envelope. The patient and the independent reviewer will be blinded as to which treatment group the patient is assigned to. This information will be linked to a confidential database for later review by the principal investigator.

Treatment allocation:

All eligible patients (i.e., meeting inclusion criteria and no exclusion criteria) will be treated and observed per the research protocol. All patients will maintain the right to refuse participation and receive a specific treatment of the study if desired.

Trial Population:

The target sample size is 70 patients for both the treatment and control groups (140 total) with each group split evenly between males and females. There will be one actively enrolling surgeon (Dr. Brett Levine). The goal is to enroll a total of 140 subjects experiencing joint pain that warrants a Total knee arthroplasty (TKA). The specific diagnosis for the joint pain will not direct the subjects' assignment or eligibility at the time of surgery. All 140 patients will be enrolled from the office of the primary investigator (Dr. Brett Levine). All indications for TKA will be included unless one of the exclusion criteria is met.

Eligibility Criteria:
Inclusion Criteria:

* Patients must be male or female of any race
* Ages 18-80 years old
* Patients must be undergoing an elective, primary knee arthroplasty performed by the principal investigator

Exclusion Criteria:

* Allergy or intolerance to the study materials
* Surgical intervention during the past month for the treatment of the painful joint or its underlying etiology
* History of previous surgeries on the affected joint including previous arthroscopy (open surgeries)
* Women that are pregnant or may become pregnant
* Patient declines to participate
Effects of Blue of Glasses VS Standard Lenses on Contrast Sensitivity & Visual Fatigue in Myopic & Non-Myopic Adults

This study investigates the effects of blue light-blocking glasses compared to standard lenses on contrast sensitivity and visual fatigue in myopic and non-myopic adults. With the growing use of digital screens, blue light exposure has raised concerns due to potential eye strain, sleep disruption, and visual fatigue.

While blue light-blocking lenses are marketed to address these issues, evidence of their efficacy, particularly for different refractive errors like myopia, remains inconclusive. Using a randomized controlled design, this study will assess both groups across specific visual tasks to measure contrast sensitivity and visual fatigue. Outcomes are evaluated using validated tools, including the Computer Vision Syndrome Questionnaire (CVS-Q) and Visual Fatigue Questionnaire (VFQ), with measurements taken at baseline, 2 weeks, and 4 weeks. Findings are expected to clarify the potential advantages of blue light-blocking glasses over standard lenses, aiding in evidence-based recommendations for adults with varying visual needs.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-50 years.
* Both myopic (with any degree of myopia) and non-myopic adults.
* Participants who use computer screens for at least four hours per day.
* Individuals currently using corrective lenses or willing to wear study-provided glasses during the experiment.
* Individuals willing to complete the study protocol, which includes attending follow-up examinations and filling out visual fatigue questionnaires.

Exclusion Criteria:

* A history of any serious vision-related condition (such as glaucoma, cataracts, or retinal problems).
* Individuals who have already undergone refractive surgery (e.g., LASIK) or other types of eye surgery.
* Systemic conditions affecting vision include diabetes, neurological problems, and any other ailment that may impair visual ability.
* Taking drugs that are known to impair vision or produce visual tiredness (for example, certain antihistamines and antidepressants).
* Pregnant women's visual performance may be affected by hormonal changes.
* People with uncorrected vision difficulties cannot use the prescription lenses during study time.
* Participants who are allergic or sensitive to lens materials.
Palliative Chemotherapy in Treating Patients With Advanced Colorectal Cancer

RATIONALE: Palliative chemotherapy may help patients with advanced colorectal cancer live longer and more comfortably.

PURPOSE: Randomized phase III trial to compare the effectiveness of and quality of life following three different palliative chemotherapy regimens in treating patients with advanced metastatic or recurrent colorectal cancer.

OBJECTIVES: I. Compare the survival and quality of life of patients with metastatic or recurrent colorectal cancer receiving palliative therapy with leucovorin/fluorouracil vs. continuous-infusion fluorouracil vs. ICI D1694. II. Compare the survival and quality of life of patients with stable or responding disease after 12 weeks of initial treatment randomized to receive 12 additional weeks of chemotherapy vs. no further treatment.

OUTLINE: This is a randomized study. Patients are stratified by participating institution. Patients are randomized to one of three treatment regimens. The first group receives leucovorin followed by fluorouracil every 14 days for a total of 6 courses. The second group receives continuous-infusion fluorouracil for 12 weeks. The third group receive ICI D1694 every 21 days for a total of 4 courses. Patients without progressive disease or excessive toxicity after 12 weeks of treatment are then randomized to receive continuing chemotherapy in 12 weekly cycles of their assigned chemotherapy or to proceed to observation with no further therapy, until evidence of disease progression. Patients are followed every 6 weeks.

PROJECTED ACCRUAL: A total of 900 patients will be entered.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed adenocarcinoma of the colon or rectum in one of the following categories: Locally advanced, metastatic, or recurrent disease suitable only for palliative chemotherapy Evaluable disease outside prior radiotherapy field Patients with disease confined to the liver are referred to protocol MRC-CR05

PATIENT CHARACTERISTICS: Age: Not specified Performance status: WHO 0-2 Life expectancy: Greater than 3 months Hematopoietic: WBC at least 4,000 ANC at least 2,000 Platelets at least 100,000 Hepatic: Not specified Renal: Creatinine no greater than 1.25 times normal OR Creatinine clearance greater than 65 mL/min Cardiovascular: No uncontrolled heart failure No uncontrolled angina Other: No uncontrolled medical illness (including infection) Able and willing to complete quality-of-life questionnaires No prior or concurrent malignancy likely to interfere with protocol treatment or evaluation

PRIOR CONCURRENT THERAPY: No prior systemic chemotherapy except fluorouracil-based adjuvant regimen (e.g., QUASAR) At least 6 months since chemotherapy
The Treatment and Intra-operative Imaging of Scaphoid Fracture Reduction and Fixation

Scaphoid fractures are the most common carpal bone fractures, and second most common wrist fractures (second to distal radius fractures). Lack of proper immobilization or displacement of these fractures commonly results in fracture nonunion or malunion followed by the development of wrist post-traumatic osteoarthritis. In addition, proper reduction and fixation of these fractures are challenging to the most experienced hand surgeons.

The investigators are going to follow-up the patients population suffering from Scaphoid fractures(nonunion included) for one year. The investigators will evaluate this follow up results in two ways:

1. Intra-operative imaging of scaphoid fracture fixation - feasibility evaluation.
2. Treatment of scaphoid fracture non-union.


Eligibility Criteria:
Inclusion Criteria:

1. Ages of 18 and 60 during the study period;
2. Scaphoid fractures to be operatively reduced and fixated, including fracture non-unions;
3. Signed informed consent.

Exclusion Criteria:

1. Non-displaced fractures of the scaphoid.
2. Soldiers in active military service.
3. pregnant women
HELPing Older People With Very Severe Chronic Obstructive Pulmonary Disease Towards the End of Their Lives: Developing, Piloting and Refining a Practical Intervention (HELP-COPD)

The purpose of this study is to develop, refine and pilot a novel complex (HELP-COPD) assessment, undertaken during or immediately after a hospital admission, which addresses the holistic care needs of people with severe chronic obstructive pulmonary disease (COPD).


Eligibility Criteria:
Inclusion Criteria:

* Registered with Lothian General Practice
* Admitted with an exacerbation of COPD as their primary diagnosis at Royal Infirmary of Edinburgh

Exclusion Criteria:

* People with lung cancer
* People unable to give informed consent and complete questionnaire booklets in English
Balancing Risk: Red Blood Cell Transfusion Strategies In Cardiac Surgery

The primary purpose of this study is to determine the best blood level to begin transfusing red blood cells in individuals undergoing cardiac surgery.

The secondary aim is to determine the impact of red cell transfusion on health-related quality of life following surgery.

Consecutive consenting patients who meet the inclusion criteria will be randomized to one of 2 transfusion groups based on their HCT value.

Hematocrit Groups:

1. 24%
2. 28%

Red blood cell transfusion will be given only when hematocrit values fall below the assigned group value. When the hematocrit value falls to a value less than the value for the randomized group a 1 unit RBC transfusion will be administered. Following administration of the 1 unit transfusion a repeat HCT is performed; if the hematocrit value responds to transfusion and is greater than or equal to the randomized group no further transfusions will be administered. A measurement of the patient's HCT after each unit of RBC administered is required prior to administering additional units. If a patient's hematocrit is greater than the value for the group which they are randomized, no transfusion of RBC is necessary. Other management decisions are left up to the discretion of the care team. Adherence to the treatment protocol will be required for the patients in the operating room, intensive care unit and postoperatively until discharge from the hospital.

Before surgery, the patient will be asked to respond to a quality-of-life questionnaire. Follow up phone calls will be made by Study personnel at 1 and 3 months after surgery to ask the same questions.

Eligibility Criteria:
Inclusion Criteria:

* All primary and reoperative adult cardiac surgical patients undergoing cardiopulmonary bypass for coronary artery bypass grafting, coronary artery bypass grafting with a valve procedure, isolated valve procedures and ascending aortic repair for aneurysm or dissection procedures.

Exclusion Criteria:

* Age less than 18 years
* Congenital procedures
* Emergencies
* descending thoracic aortic aneurysm repairs
* Left or right ventricular assist devices
* Left ventricular aneurysm resections
* Heart or lung transplantation
* Those unable to receive blood for religious reasons
Circumferential Submucosal Incision Endoscopic Mucosal Resection Versus Conventional Endoscopic Mucosal Resection of Colonic Polyps

That Circumferential Submucosal Incision Endoscopic Mucosal Resection (CSI-EMR) will be at least as safe but more effective than conventional EMR for injection assisted EMR of large laterally spreading tumour and sessile polyps of the colon.

The investigators have recently developed a new, and the investigators believe safer and more effective technique for endoscopic mucosal resection (EMR). Utilising the new method the investigators make small cuts around the polyp to isolate it. Subsequently the Gelofusine solution is injected beneath the polyp and provides greater elevation. This allows us to improve the chance of removal of the entire polyp with one attempt in one piece. It is preferable to remove the polyp in one piece as it minimises the chance of leaving residual polyp tissue behind. Our team has recently completed an animal study comparing our newly developed technique to conventional EMR. The investigators have found significant improvements in our ability to completely remove the polyp in one attempt. There have also been recent studies overseas that have shown this new technique to be quite effective.

Eligibility Criteria:
Inclusion Criteria:

* Can give informed consent to trial participation
* Age greater than 18
* Adenomas that have not have previously been attempted for resection (i.e. naïve lesions)
* Adenoma size greater than 20 mm

Exclusion Criteria:

* Age less than 18
* Previous resection or attempted resection of target adenoma lesion
* Pregnant patients
PET Imaging of Chronic Pain Syndromes

Central nervous system (CNS) changes associated with pain have been difficult to measure until the development of functional neuroimaging techniques such as positron emission tomography (PET). We have previously observed asymmetry in the thalamus associated with chronic pain that altered during acupuncture therapy. Imaging studies of therapeutic techniques for chronic pain in animals and humans have been quite limited. This study will be the first to utilize FDG PET-MRI imaging of both the brain and body in order to assess CNS changes and peripheral body changes related to chronic pain and its potential management.

The proposed study is based on our growing understanding of chronic pain and our ability to use functional brain imaging to study in vivo neurophysiologic processes. It is important to understand the brain and body mechanisms of chronic pain in order to better determine therapeutic interventions to reduce pain. Part of the difficulty in treating chronic pain is to determine how better to diagnose what specific issues are affecting the brain and body that result in chronic pain. Participants will undergo a small battery of diagnostic tests that include magnetic resonance imaging (MRI), positron emission tomography (PET). A secondary goal of this study is to determine if undergoing chiropractic care alters body or brain physiology in patients with chronic pain.

Eligibility Criteria:
Inclusion Criteria for Chronic Pain Patients:

* Age greater than 18 years old.
* Have chronic pain symptoms for \>3 months;
* Have moderate pain (\>3/10) in 2 or more areas for more than 5 out of 7 days
* Is planning on undergoing chiropractic care for the clinical management of the chronic pain.
* May be on pain medications provided that they are on a stable dose for at least 1 month
* Patients have no other pre-existing and active significant medical, neurological, or psychological disorders.
* Minor, stable health problems that should have no substantial effect on cerebral blood flow will be allowed (i.e. controlled hypertension, medication controlled diabetes).
* Patients will be allowed to be taking medications or supplements at the initial intake, but they must be on a stable dose regimen for at least 1 month.
* Able to give informed consent and willing to complete the study at Thomas Jefferson University and Marcus Institute of Integrative Health.

Inclusion Criteria for Healthy Controls:

* No significant current active medical conditions.
* Stable medical conditions as determined by the PI are allowed.
* No brain or body abnormalities that would affect the acquisition or analysis of the scan.

Exclusion Criteria for Chronic Pain Patients and Healthy Controls:

* Pregnant or breast feeding
* Enrollment in active clinical trial/ experimental therapy within the prior 30 days.
* Subject is unable or unwilling to lie still in the scanner (i.e. due to claustrophobia or weight)
* Subject has metal in their body or other reason that they cannot undergo magnetic resonance imaging.
Limited Ankle Dorsiflexion and Effect on Single Limb Squats in Individuals With Patellofemoral Pain

The purpose of this graduate student research study is to investigate the relationship between limited ankle dorsiflexion and the potential effects on a single limb squat task in the Patellofemoral/Knee Pain population.

1. Participants will undergo Covid screening prior to filling out consent form and PHI. Randomization will occur to create an experimental group and a minimal intervention group.
2. Participants will complete two self-reported questionnaires on how their diagnosis affects functional activities.
3. Dorsiflexion range of motion in a weight bearing position will be taken.
4. Hip abductor strength on tested limb will be measure on isokinetic device.
5. The Lateral Step Down test will be conducted for 6 trials on each participant, 3 with a heel wedge and 3 without, movement recorded, and graded using two motion capture devices.
6. The experimental group will receive two interventions to increase dorsiflexion range of motion. The minimal intervention group will read and infographic and complete 5 minutes of treadmill walking.
7. Each participant will then have their dorsiflexion measured again prior to completing another 3 trials of the Lateral Step Down test.

Eligibility Criteria:
Inclusion Criteria:

* History of active Patellofemoral Pain for at least 6 months
* No clinic based therapeutic interventions for a 6-month period prior to testing
* Females aged 18-59 years' old
* Limited ankle dorsiflexion as noted by \<45degs using the weight bearing lunge test

Exclusion Criteria:

* History of musculoskeletal surgery or fractures on the tested leg or lumbar spine that could affect their biomechanics during the study
* History of soft tissue or skeletal abnormalities in the tested limb
* Current knee effusion
* Resting pain greater than 5/10
Digital Rewards and Retention in a M-health App

Attrition and user engagement are two challenges that eHealth interventions struggle with. Attempts to address this have been previously made through gamification, instructional design and using different types of incentives. Overall, any type of reward, be it non-financial or monetary is better than the controls, but the latter usually produce a greater effect. It is also worth mentioning that having an affective value attached to the reward itself is also important to user retention and engagement. Given the ever-increasing interest in cryptocurrency and its current relevance, the present study - a randomized clinical trial with three arms - aims to compare cryptocurrency to non-monetary rewards regarding their effectiveness in reducing attrition and increasing engagement. In order to do this, a mental-health computerized intervention will be developed, in which the users will have to complete several modules, during which time they will be rewarded either with cryptocurrency, sweepstake rewards (e.g., vouchers), or nothing.

Albeit effective, eHealth interventions suffer from very high dropout rates. Finding novel ways in which to maximise user retention and engagement in such settings can be beneficial, and exploring cryptocurrency as a potential reward may be worthwhile, since motivation seems to increase as the reward is perceived as more meaningful by the recipient.

The design is experimental, between-subjects, with one independent variable (the type of reward offered) and mental health (e.g., depression, anxiety, stress, and transdiagnostic constructs) as well as engagement and retention outcomes. Thus, three groups will be formed: two in which participants will be enrolled in the modular MOTO intervention and will receive different rewards, and one in which they will not receive any intervention or reward but will be evaluated as part of a waitlist control group. The modular MOTO intervention involves, in addition to the mentioned assessments, the completion of six weekly modules, each focused on specific aspects of mental health and containing exercises that may improve psychological well-being. These modules are automated, requiring no interaction with others (except for communication between participants and research team). Each of these modules contains the following: psychoeducational section(s) that participants must complete; a short test of 5-10 questions after each section to assess understanding of the material; (only for the first two groups); a link where they can obtain their rewards; the exercise corresponding to that module; the evaluation corresponding to that module.

Eligibility Criteria:
Inclusion Criteria:

* English speaking

Exclusion Criteria:

-