cyrilzakka/clinical-trials huggingface dataset:
Fear-focused Self-Compassion Therapy for Young Breast Cancer Patients' Fear of Cancer Recurrence

Few studies have tailored psychological intervention for fear of cancer recurrence (FCR) in young breast cancer patients, and the long-term efficacy of psychological intervention and its underlying mechanism are still unknown. To fill this knowledge gap, this protocol aims to evaluate the short-term and long-term effectiveness of Fear-focused Self-Compassion Therapy, as well as this therapy's psychological and physiological mechanisms in reducing severe FCR in young women with breast cancer.

This study will be a randomized controlled trial recruiting 160 Chinese young female breast cancer patients with severe FCR. Participants will be randomized to the Fear-focused Self-Compassion Therapy group or control group (1:1). Measurement will be completed at baseline (T0), immediately completing intervention (T1), after 3 months (T2), after 6 months (T3) and after 12 months (T4). Primary outcomes are FCR severity; secondary outcomes are self-compassion, neurophysiological data (i.e., salivary alpha amylase and heart rate variability), attentional bias for FCR, rumination, catastrophizing thinking, and psychological symptoms. The Fear-focused Self-Compassion Therapy is based on the theories of FCR development and self-compassion, and consists of eight-week face to face group sessions.


Eligibility Criteria:
Inclusion Criteria:

* (1) are diagnosed with breast cancer (including various cancer stages and subtypes);
* (2) are aged 18-45 years;
* (3) can sign written informed consent;
* (4) can read and write Chinese;
* (5) have severe FCR, with scores \> 13 on the FCRI severity subscale.

Exclusion Criteria:

* (1) currently have psychiatric and psychological illness;
* (2) have other types of tumor;
* (3) had a previous cancer recurrence;
* (4) are participating another psychological intervention at the start of the study or during their eight-week therapy.
Plasma Glucagon-like Peptide-1 Levels and In-hospital Complications in ST-segment Elevation Myocardial Infarction

Glucagon-like peptide-1 (GLP-1), produced mainly in enteroendocrine cells, participates in energy homeostasis and glucose metabolism by regulating islet hormone secretion, gastrointestinal motility, and food intake, making GLP-1 agonist a treatment for diabetes and obesity. Pre-clinical and clinical studies have demonstrated that GLP-1 also has cardio-protection effects. GLP-1 agonists is able to improve markers of cardiac function, reduce myocardial infarct size and post-myocardial infarction remodeling in experimental myocardial infarction. And GLP-1 infusion improved left ventricular function and increases myocardial salvage in patients with acute myocardial infarction (AMI). The investigators' previous study found that GLP-1 analogues attenuated ischemia-reperfusion induced apoptosis of stem- and myocardial microvascular endothelial cells, and liraglutide (a GLP-1 analog) usage during hospital stay can prevent no-reflow and improve heart function in AMI. Therefore, the investigators carried out a cohort study to evaluate the association between plasma GLP-1 and in-hospital complications in patients with ST-segment elevation myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* a diagnosis of STEMI and needed PCI

Exclusion Criteria:

* patients with cancer patients who used DPP4 inhibitor patients who used GLP1 analogue
Integrating Lifestyle Therapy for Diabetes Prevention Into Primary Care

An educational intervention in the General Medicine Clinic aimed at both primary care providers (PCPs) and their patients with metabolic syndrome/pre-diabetes (MetSyn/PDM). Improving PCPs ability to detect and manage MetSyn/PDM, as measured by the increased incorporation of MetSyn/PDM into PCPs care plan, and increasing patients' awareness of healthy lifestyle behaviors results in positive patient health behaviors and outcomes.

The highest diabetes prevalence in the US is among African Americans (13.3%), American Indians (12.8%), and Mexican Americans (9.5%) with 8.7% of European Americans diagnosed with diabetes. In addition, certain minorities also have much higher rates of diabetes-related complications and death, in some instances by as much as 50% more than the general population, highlighting that the greatest need for preventive measures are amongst ethnic minorities.

The efficacy of lifestyle intervention in reducing the incidence of type 2 diabetes has been established by the Diabetes Prevention Program and other studies. The Cook County Bureau of Health Services, a publicly-funded healthcare system serving a primarily low-income, uninsured, ethnically diverse population in Chicago, IL, currently treats an estimated 40,000 patients annually for type 2 diabetes and estimates that another 85,000 to 100,000 patients are at risk for developing diabetes.

Our primary objective was to test the feasibility of integrating less intensive lifestyle intervention therapy into patient visits with their primary care provider to improve weight loss and decrease the intensity of metabolic syndrome and pre-diabetes risk factors. The site of the study is the General Medicine Clinic, a busy primary care outpatient site treating approximately 12,000 patients/year and 200 patients/day, staffed primarily by medical residents supervised by attending physicians.

Eligibility Criteria:
Inclusion Criteria:

* Has metabolic syndrome as defined by three or more of the five risk factors:

  * elevated blood pressure (BP) above 130 mm Hg systolic and/or 85 mm Hg diastolic or drug therapy for elevated blood pressure
  * elevated waist circumference (WC)above 35" (female) or above 40" (male)
  * reduced high-density lipoprotein (HDL) of below 40 mg/dl (male) or below 50 mg/dl (female) or drug therapy for reduced HDL
  * elevated triglycerides (TG) of 150 mg/dl or above or drug therapy for elevated TG
  * elevated fasting blood glucose (FBG) of 100 mg/dl and above and below 126 mg/dl)or pre-diabetes as defined as elevated FBG.
* Has a primary care provider in the General Medicine Clinic (GMC).

Exclusion Criteria:

* Has been diagnosed with any of the following:

  * diabetes
  * known CAD (MI, CABG, PTCA)
  * congestive Heart Failure NYHA Class III or IV
* Life expectancy less than 2 years
* Non-English speaking patient
* Patient whose physician is a PGY-3 resident, graduating before projected completion of the study
Epidemiological Study of the Prevalence of Age-Related Macular Degeneration in Portugal

This is an epidemiological study to assess the the prevalence of Age-Related Macular (ARM) Degeneration in Portugal.


Eligibility Criteria:
Inclusion Criteria:

* Participants with 55 years-old

Exclusion Criteria:

* None
Feasibility of Closed-loop TCI Based on New EEG Baseline in the Presence of Low Dose of Esketamine

The propofol-remifentanil closed-loop TCI system based on EEG guidance has been clinically verified, which enables more precise anesthetic dosing. As an adjunct to anesthesia, esketamine has been shown to stabilize hemodynamics, reduce opioid use, and reduce postoperative nausea and vomiting. However, due to its specific electroencephalographic excitatory effect, esketmine's clinical use in close-loop system has been limited. The aim of this experiment was to determine the specific impact of esketamine on EEG and thus obtain a new EEG baseline for close-loop system, which can broaden the application of close-loop TCI system in combination with other drugs.

The trial is devided into two phases. In the first phase, we statistically analyzed and calculated the changes of BIS by collecting a sample size of EEG changes after administering low dose of esketamine. We used 0.2 mg/kg as a loading dose and followed by a rate of 5ug/kg/min as esketamine administration and observe the changes in BIS each for 30 minutes.

In the second phase, we obtain the BIS quantification value N with the addition of a small dose of esketamine in the first phase and thus obtain a new EEG baseline 50+N. By comparing this EEG-adjusted group with the control group, which run the close-loop system based on original BIS baseline without esketamine, whether the closed-loop system can be better applied based on the new BIS baseline under low dose of esketamine.

Eligibility Criteria:
Inclusion Criteria:

* BMI 18\~27kg· m-2;
* American Society of Anesthesiologists (ASA)physical status I\~II;
* Undergoing elective laparoscopic surgery.

Exclusion Criteria:

* Known or suspected neurological diseases, tumors, stroke, degenerative neurological diseases, epileptic seizures, serious head injuries, cognitive disorders, post-traumatic stress disorder, mental illnesses, severe depression, psychosis, etc.;
* Contraindications to ketamine, propofol or remifentanil;
* Use of psychotropic drugs within the past 7 days;
* History of drug abuse or drug addiction within the past 30 days or during pregnancy;
* Current participation in any other studies involving other drugs or devices.
Bifocal Soft Contact Lenses and Their Effect on Myopia Progression in Children and Adolescents.

The purpose of this study is to determine whether bifocal soft contact lenses are effective in controlling the progression of myopia in children and adolescents that exhibit a tendency to excessively cross their eyes while reading (esophoria or eso fixation disparity). Several studies have demonstrated that bifocal or progressive multifocal spectacles are effective in slowing the progression of myopia in children either with near point esophoria and/or with inadequate focusing at near. A prominent theory for one cause of myopia progression is that poorly focused images on the back of the eye (retina) cause the eye to lengthen, causing an increase in myopia. Bifocal contact lenses may reduce this retinal defocus, reducing the stimulus to eye elongation, and thus may reduce myopia progression.

Myopia has become the focus of growing attention and concern because the prevalence of myopia appears to increasing in some populations (reaching 90% for some university student populations in Asia). There are serious risks to higher levels of myopia, including cataracts, glaucoma, retinal detachment and myopic retinal degeneration. Several studies have shown mild to moderate control of myopia progressionwith bifocal or multifocal spectacles in children with esophoria at near and/or with accommodative deficiencies. Pilot studies by the P.I. have suggested that bifocal contact lenses may control myopia progression in children with near point eso fixation disparity.

CONTROL is a controlled, randomized, prospective, double-blind, one year study of the changes in myopia in 80-90 subjects from age 8-18 with low to moderate levels of myopia, low levels of astigmatism, and eso fixation disparity at near, when fitted with either bifocal soft contact lenses or single vision soft contact lenses. The primary outcome measures will be cycloplegic refraction and axial length measures.

Eligibility Criteria:
Inclusion Criteria:

* Myopia between -0.50 and -6.00
* Eso fixation disparity at 33cm with distance correction
* Astigmatism 1.00 or less
* Ability to wear soft contact lenses

Exclusion Criteria:

* Presence of ocular disease preventing wear of contacts
* Pregnancy or nursing
* Use of certain medications
Importance of Integrated Pulmonary Index in Pediatric Endoscopy

Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2). It is a valuable monitor for sedation procedures and can provide early warning during cardiorespiratory derangements. In this study, we wanted to evaluate the value of IPI in cases of pediatric endoscopy performed under sedation. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.

Upper gastrointestinal system (GIS) endoscopy is a common diagnostic or interventional procedure in cases such as foreign body ingestion, gastritis, peptic ulcer, esophagitis, esophageal variceal bleeding. Lower GIS endoscopy is a procedure performed in cases such as Crohn's or Ulcerative Colitis diseases, colon polyps, diverticular disease. It is routinely performed under general anesthesia or sedation in pediatric cases. In our clinic, we routinely perform diagnostic or interventional pediatric upper and lower endoscopy procedures with the non-operating room anesthesia team under monitored anesthetic care (MAC). Routine monitoring of MAC consists of electrocardiography (ECG), non-invasive blood pressure (NIBP), and peripheral oxygen saturation (SpO2). These monitorizations are described as minimum in many practice guidelines, and sometimes monitors such as end-tidal carbon dioxide (ETCO2), body temperature, analgesia/nociception index (ANI) can be added to them.

The Integrated Pulmonary Index (IPI) is a tool that provides numerical values on a scale of 1-10 based on physiological parameters such as peripheral oxygen saturation (SpO2), pulse rate, respiratory rate, end-tidal carbon dioxide (ETCO2).(1,2) When these parameters exceed physiological limits, patients require interventions consisting of various maneuvers or drug administration in order to maintain the normal functioning of the cardiorespiratory system. If we look at the scoring, a score of 8-10 is considered normal, a score of 5-7 indicates a situation that may require intervention, and a score of 1-4 indicates that the patient needs intervention.

The above-mentioned IPI is a relatively new tool, and there is limited data in the literature regarding its usability in patients undergoing interventional procedures under MAC.(3,4) In this study, we wanted to evaluate the safety of IPI in cases of pediatric endoscopy performed under sedation. Routine monitoring and drug applications for the procedure will be in accordance with the institutional protocols, and additional IPI monitoring will be performed. Our outcome measure will be the correlation of IPI values with standard monitoring parameters.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1-3 physical status
* Elective upper or lower gastrointestinal tract endoscopy

Exclusion Criteria:

* ASA physical status of 4 or more
* Patients with any contraindication for off-site anesthesia
Detection of Minimal Residual Disease in Resectable Stage II-IIIB Non-small Cell Lung Cancer

Predicting relapse and overall survival in potentially resectable Stage IIIA-IIIB Non-small Cell Lung Cancer (NSCLC) patients remains challenging. It is now widely recognized that patients with detectable MRD have a worse prognosis than those with undetectable MRD. Therefore, investigators performed this prospective clinical trial to evaluate the predictive value of MRD with increased risk of relapse and improves prediction of outcome in potentially resectable Stage IIIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy. In this study, investigators will pay more attention to the long-term follow-up time and dynamic monitoring of MRD. The predictive value of MRD with Disease-free survival (DFS) rate was observed as the primary endpoint. Besides that, the correlation of MRD with major pathologic response (MPR) rate, pathologic complete response (pCR) rate，event-free survival(EFS) rate and overall survival (OS) were observed as the second endpoints. Investigators hope it will provide a new insight for these potentially resectable Stage IIA-IIIB NSCLC with neoadjuvant chemoimmunotherapy.


Eligibility Criteria:
Key Inclusion Criteria:

* Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 2.
* Have previously untreated and histological examination confirms resectable stage II-IIIA/IIIB non-small cell lung cancer (according to the 8th edition of the AJCC TNM staging criteria), and the pathological type of squamous cell carcinoma and non-squamous cell carcinoma needs to be distinguished, and EGFR, ALK, and ROS1 should be negative for non-squamous non-small cell lung cancer
* Adequate organ function and expected survival time ≥ 12 weeks;
* Evidence of post-menopausal status or negative urinary or serum pregnancy test for female pre-menopausal patients.

Key Exclusion Criteria:

* Presence of mixed carcinoma component on histology.
* Patients with other active malignancies within 5 years prior to enrollment.
* Known active autoimmune diseases.
* Currently participate in an interventional clinical study treatment or have been treated with another drug or investigational device within 4 weeks prior to the first dose.
* Use of immunosuppressive agents within 14 days prior to the first dose of study treatment.
* Presence of other uncontrolled serious medical conditions.
Comparison of Different Treatment Methods in Patella Chondromalacia

Chondromalacia patella (CMP) is a common condition in patients presenting to healthcare units with anterior knee pain (1).

Patellofemoral pain syndrome (PFPS) is the most common type of pain in runners with a prevalence of 17%; it is limited to the anterior knee or the area behind the patella between the edges of the patella. Although PFPS and CMP are often considered to be the same disease, there is still controversy about the subject. It is caused by decreased quadriceps muscle strength, change in mechanical loading, lower limb kinematics and differentiation in muscle activation patterns during running .

Eligibility Criteria:
Inclusion criteria:

* 18-65 years of age.
* Being diagnosed with chondromalacia
* Participate in the work on a voluntary basis
* Obtaining informed consent from them

Exclusion criteria:

* Fracture, ligament or muscle tear in the lower extremity within the last 3 months.
* Having a systemic disease
* Having a serious injury in the last 3 months
Incorporating Biometric Data for Patients Receiving Concurrent Chemotherapy & RT

This study will assess the feasibility of incorporating biometric data via wearable health technology (WHT) into the radiation oncology (RO) clinic workflow for patients receiving concurrent radiation therapy and systemic therapy (CRT) for cancer. The investigators hypothesize that a practical workflow could be created within a busy community RO practice that will allow providers and patients to readily appreciate physiologic declines during concurrent CRT.

Subjects will be asked to wear a device as part of this study that will collect their biometric data (heart rate, number of steps taken per day, etc) called a WHT device throughout their treatment and for 4 weeks afterward. Subjects will be asked to upload the data from their devices onto the computers in the clinic for the assessment.


Eligibility Criteria:
Inclusion Criteria In order to participate in this study a subject must meet all of the eligibility criteria outlined below.

Subjects

1. All genders aged ≥ 18 years of age.
2. English-speakers
3. Able to understand and cooperate with study procedures.
4. Signed and dated informed consent.
5. Subjects being seen at Novant-New Hanover Regional Medical Center for diagnosis and management of cancer.
6. Subjects prescribed to receive concurrent radiation therapy and systemic therapy either definitively or postoperatively.
7. Signed and dated HIPAA authorization for the release of personal health information.

Providers

1. All genders aged ≥ 18 years of age.
2. English speakers.
3. Able to understand and cooperate with study procedures.
4. Signed and dated informed consent.

Exclusion Criteria Both Subjects and care providers

1. Has dementia, altered mental status, or any psychiatric or co-morbid condition prohibiting the understanding or rending of informed consent
Clinical Evaluation of the APTIMA® HPV Assay Using the TIGRIS® System

The purpose of this study is to provide data on the performance of the APTIMA HPV Assay using the TIGRIS System in detecting HPV types that may cause cervical cancer.

The primary objective of the clinical trial is to evaluate the APTIMA HPV Assay, using the TIGRIS System, in cervical cancer screening programs. This will be achieved by determining the performance of the assay for detecting high-risk human papillomavirus (HPV) types in women with known cervical disease status. The assay will be evaluated in sample populations of women with ASC-US Pap test results ("ASC-US results") and women 30 years of age or older ("30+ years of age") with negative (NILM) cytology results.

Eligibility Criteria:
Inclusion Criteria:

* Female 21 years or older (ASC-US study only)
* Female 30 years or older (Adjunct and ASC-US studies)
* Subject attending a participating clinic and undergoing a Pap screening exam during the clinic visit
* Ability to comprehend and sign an IRB-approved Informed Consent Form

Exclusion Criteria:

* Diagnosis of cervical disease (cancer or precancerous condition) in the past 12 months
* Abnormal Pap test result in the past 12 months
* Subject under 18 years of age and consenting to the study without the presence of their parent or legal guardian
* Known to be pregnant
* Having an illness or medical condition that could interfere with or affect the conduct, results, and/or completion of the clinical trial
* Having an illness or medical condition that the investigator or physician feels would create an unacceptable risk to the subject if she enrolled into the clinical trial
* Prior vaccination for HPV
Circadian Variation in Serum-progesterone Levels Following Controlled Ovarian Hyperstimulation.

The aim of the study is to investigate the circadian variation in serum-progesterone in women undergoing controlled ovarian stimulation.


Eligibility Criteria:
Inclusion Criteria:

Women undergoing standard IVF/ICSI treatment.

Exclusion Criteria:

Previous participation in the study.
Effects of Pepper Gas Exposure in Non-combatant Bystanders.

Pepper sprays and pepper gas grenades are used by riot police at various places in the world for crowd control. Data about the acute effects based on human studies is extremely scarce. Kashmir valley in the northern Indian state of Jammu \& Kashmir has witnessed political turmoil for the past 22 years and incidents of stone pelting are common wherein groups of youth indulge in stone pelting at the security personnel. While there have been previous episodes of fatalities associated with incidents of firing by the security personnel; non lethal methods are adopted routinely now. These include lathis, water cannons, tear gas and more recently the pepper gas grenades. The pepper grenades explode in the area and the adverse effects are perceived by the population in the area too who are even sitting in their homes. The study proposes to observe the health effects of the pepper gas exposure in non-combatant civilians.

Eligibility:

History of exposure to a pepper grenade explosion.

Exclusion:

Participation in combat operation/ stone pelting/ demonstration.

Eligibility Criteria:
Inclusion Criteria:

All participants with a history of exposure to pepper gas grenade explosion

Exclusion Criteria:

Combatant role while exposure