cyrilzakka/clinical-trials huggingface dataset:
PD-L1-expressing Regulatory T Cells in Localized Prostate Cancer Patients Undergoing Iodine-125 Permanent Brachytherapy

Immunotherapy is currently revolutionizing the field in oncology. However, prostate cancer is poorly responsive to immune checkpoint inhibition. The combination of immunotherapy and radiotherapy is an emerging clinical treatment aradigm. X-ray radiation treatment can activate both the adaptive and innate immune systems through directly killing tumor cells, causing mutations in tumor-derived peptides, and causing localized inflammation that increases immune cell trafficking to tumors. Recently, preclinical study reported that immune checkpoint inhibition combined with radiotherapy treats CPRC with significant increases in median survival compared to drug alone.

Permanent brachytherapy is one of those standard treatments for localized prostate cancer patients.

Biopsy confirms prostate cancer. Blood and urine of localized prostate cancer patients will be collected before and at different time points after permanent brachytherapy (1, 3, 6, and 12 months)

Eligibility Criteria:
Inclusion Criteria:

- Biopsy confirms prostate cancer

Localized Prostate Cancer, ≤cT3

No chemotherapy or Hormonal therapy before Permanent Brachytherapy

Exclusion Criteria:

- Unacceptable operative risk

Poor anatomy which in the opinion of the radiation oncologist could lead to a suboptimal implant (e.g.,large or poorly healed transurethral resection of the prostate (TURP) defect, large median lobe, large gland size).

Pathologically positive lymph nodes

Significant obstructive uropathy

Distant metastases

Use steroids regularly

The diagnosis was accompanied by immune-related diseases

Allergic constitution

Abnormal white blood cell and lymphocyte counts

Ever underwent other treatments for prostate cancer, such as chemotherapy or Hormonal therapy

Accompanied by other malignancies

Splenectomy

HIV positive

Receive an anti-infective vaccine for the last 6 months
Immune Score Based Radiomics in Nasopharyngeal Carcinoma

In nasopharyngeal carcinoma (NPC), tumor, node and metastasis (TNM) staging system is the main tool for determining treatment strategy and assessment of prognosis. However, the prognoses of patients with the same TNM stage after similar treatment vary widely. The aim of this study is to establish an immune score based radiomic staging system for NPC.


Eligibility Criteria:
Inclusion Criteria:

Patients with newly histologically confirmed non-keratinizing/keratinizing carcinoma.

ECOG Performance status: 0-1 With normal liver function test (ALT, AST ≤2.5ULN) Renal: creatinine clearance ≥60ml/min Without hematopathy,marrow: WBC \>4\*109/L, HGB\>90G/L, and PLT\>100\*109/L. Written informed consent

Exclusion Criteria:

Contraindications for MRI scan Prior malignancy (except adequately treated carcinoma in-situ of the cervix or · basal/squamous cell carcinoma of the skin) Previous chemotherapy or radiotherapy (except non-melanomatous skin cancers outside the intended RT treatment volume) Patient is pregnant or lactating Any severe intercurrent disease, which may bring unacceptable risk or affect the compliance of the trial, for example, unstable cardiac disease requiring treatment, renal disease, chronic hepatitis, diabetes with poor control (fasting plasma glucose \>1.5×ULN), or emotional disturbance.
Goals for Epilepsy Clinic Visits Trial

The purpose of this project is to conduct a trial to assess whether patients that receive a tablet-based waiting room priority communication tool (the "Epilepsy Visit Planner") have improved outcomes compared to patients that do not receive the tool.

The project's hypotheses are:

* Patients that receive the Epilepsy Visit Planner will have improved patient-provider communication compared to the non-planner group.
* Patients that receive the Epilepsy Visit Planner will have improved quality of life scores.
* The Epilepsy Visit Planner will score highly on process measures of feasibility and acceptability, demonstrating suitability for future larger scale study.

Additionally, there is a related survey project that is not part of the clinical trial and will not be included in this registration information.


Eligibility Criteria:
Inclusion Criteria - Patient Participants:

* Adults with drug-resistant epilepsy
* Participants receiving care through the Epilepsy clinics at the University of Michigan

Exclusion Criteria - Patient Participants:

* \<18 years old
* Non-English speaking
* Do not clearly have drug-resistant epilepsy
* Moderate-to-severe cognitive impairment that precludes study questionnaire completion

Inclusion Criteria - Provider Participants:

-University of Michigan epilepsy providers

Exclusion Criteria - Provider Participants:

-Not University of Michigan epilepsy providers
A Brief Version of Biofeedback Therapy for Panic Disorder

The study is to examine the therapeutic effect of a brief version of biofeedback therapy (developed bu the research team) on panic disorder. It is a randomized controlled design. The severity of panic symptoms of two groups of panic patients (reveiving biofeedback therapy or not) were measured before and after the six week duration. Besides, the severity of anxiety, depressive, somatic symptoms, and physiological indexes were recorded.

The purpose of this study is trying to find out whether our newly developed brief version of biofeedback is an effective treatment approach for panic disorder. At the same time, the investigators want to clarify the change of bio- and psycho- indices present through the process. Patient recently experienced panic attacks are recruited in this study. The diagnosis of "Panic Disorder" is made by psychiatrists according to The Diagnostic and Statistical Manual of Mental Disorders(DSM-5) criteria. Subjects are randomly assigned to medication group or biofeedback therapy. The biofeedback therapy is conducted by psychologists following the structure way. Every subject will be measured both the bio and psycho indices on week 0, 3, and 6 under 6-week observation. In the end of the study, the investigators hope to analyze and clarify the treatment effects of our design, and also to exam the meanings of these indices, in order to find out an effective treatment approach.

Eligibility Criteria:
inclusion criteria: The panic disorder cases of the National Taiwan University Hospital Yunlin Branch Psychiatric outpatient department (Huwei, Douliou) have more than one time of panic attack in nearly three months.

exclusion criteria:

1. The age is younger than 20 or older than 70 years.
2. With psychotic symptoms or cognitive dysfunction.
3. A major physical illness (physical illness with fatal risks, such as cancer, myocardial infarction)
4. Unable to read or understand the questionnaire
Glidescope Videolaryngoscope and Macintosh Laryngoscope in Children

The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.

This was a prospective randomized clinical study to be performed in pediatric patients older than 1 years who are undergoing surgical procedures requiring endotracheal intubation. Time to endotracheal intubation was compared between patients intubated using a GlideScope® video laryngoscope, and those intubated by standard direct laryngoscopy. The main objective of this study was to evaluate the intubation time of Glidescope compared with Macintoch laryngoscope in pediatric patients, ease of intubation, and cardiovascular changes during intubation.

Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-II patients,
* scheduled for elective surgery under general anesthesia with endotracheal intubation

Exclusion Criteria:

* risk of pulmonary aspiration,
* presence of difficult intubation,
* emergency surgery,
* cardiovascular disease,
* respiratuar disease,
* hemodynamic instability.
The Effect of Neuroscience Pain Education on Quality of Life in Patients with Chronic Low Back Pain

Manual therapy are among the therapeutic approaches frequently used in chronic low back pain (CLBP). Although most clinicians conduct patient education according biomedical model of pain, a relatively new approach which is referred to as neuroscience pain education (NPE) is promising in patients with CLBP. Therefore the aim of this study was to investigate whether NPE in patients with CLBP who treated via manual therapy technique will produce different outcomes in terms of pain severity and QoL compared to traditional patient education.


Eligibility Criteria:
Inclusion Criteria:

* Volunteered to participate in the study.
* Patients with 18-65 years
* Had low back pain for at least 6 months,
* Reported pain severity of 5 or greater according to the numeric pain rating scale

Exclusion Criteria:

* Previous spine or lower extremity surgery
* Severe osteoporosis
* Spondyloarthropathy
* Spondylolisthesis
* Lumbar stenosis
* Lumbar fractures
* Malign tumor
Young Women's Health CoOp (Cooperative) in Cape Town

This supplement study is an adaptation of the larger NIH-funded parent study, the Women's Health CoOp+, which tests a combination biobehavioral HIV prevention approach to enhance standard HIV testing practices for alcohol and drug (AOD)-using women across the city of Pretoria, South Africa. The current supplemental study seeks to reach AOD-using female adolescents who experience the greatest burden of new HIV infections and are currently underserved by HIV and drug-treatment programs in Cape Town, South Africa and test the validation of both the instrument and adapted intervention.

This study is testing and validating both the revised instrument and adapted intervention through a small pilot trial where a cluster randomized design is used to recruit 100 participants through snowball sampling by community to either the YWHC condition or standard HIV Counseling and Testing (HCT); collect biological specimens to screen for recent drug use, pregnancy and HIV infection and provide referrals for care to resources; conduct process evaluation measures for satisfaction and a 1-month follow-up post-intervention interview assessing the feasibility and preliminary efficacy of conducting this intervention among vulnerable young women and linking them to care.

Young women from disadvantaged communities in Cape Town who have dropped out of school and who use AODs are highly vulnerable to physical victimization (violence and sexual victimization) from any perpetrator, including main sexual partners and drug-related sexual risks for HIV. Yet these vulnerable young women remain underserved by current HIV and drug treatment programs in the region, even though they are experiencing the greatest burden of new HIV infections in the country. The adapted Young Women's Health CoOp (YWHC) intervention has a high likelihood of wider implementation, sustainability, and a significant public health impact by reducing the exceedingly high HIV incidence amongst the most vulnerable populations in South Africa.

Eligibility Criteria:
Inclusion Criteria:

* Female, 16 to 21 years of age
* Dropped out of school for at least 6 months
* Currently dropped out of school
* Have not completed matric or N 3 certificate
* Have used at least one drug (which can include alcohol) at least weekly in the past 90 days
* Report unprotected sex with a male partner in the last 90 days
* Able to provide informed assent to participate or informed consent if at least 18 years old
* Live in a targeted community Delft, Khayelitsha, or Mfuleni

Exclusion Criteria:

• Have been a part of formative activities
A Clinical Evaluation of AI Solutions Developed in the CHAIMELEON Project for Cancer: Prostate, Lung, Breast, Colon and Rectum

The goal of this observational study is to see how useful an experimental viewer and AI solutions are for clinicians in their daily work. The investigators want to find out if the AI helps clinicians interpret medical images for different types of cancer.

The AI solutions aim to:

* Classify whether prostate cancer is low or high risk
* Classify the histological subtype in breast cancer
* Estimate the life expectancy of patients with lung cancer
* Determine the size of colon cancer, lymph node involvement and the possibility of metastasis..
* Assess the invasion of sorrounding tissues in the case of rectum cancer. The study will involve clinicians from various centres who will review a set of cases not previously analysed by the AI. Clinicians will do this in two phases: first using only their own expertise and then with the help of the AI solutions.

The technical team want to see if the AI solutions assist clinicians and could become useful in the everyday clinical practice. Clinicians will complete a survey to share their feedback on the usability of the platform and how helpful the AI solutions are.

In order to conduct a robust clinical validation, the investigators have designed a study on the required sample size. The study is design to evaluate the role of an AI-assisted tool as a support for improving the daily clinical work. The investigators used an online website (https://statulator.com/SampleSize/ss2PP.html) for the calculation and use the "paired binary proportions" option. Using the case of prostate cancer, the investigators want to compare the probability of correct risk classification in prostate cancer by clinicians alone and/or guided by AI. The study will have a significance (α) = 0.05; power (β) = 80%; the analysis will be "two sided" and with equal group sizes.

An 10% improvement in cancer risk classification was observed when clinicians had access to an AI tool solution (Yilmaz et al.,). In addition, the authors reported that expert readers had an accuracy rate of 81% compared to 69% for novice readers when determining the Gleason score of lesions (a medical term used in pathology to classify the aggressiveness of cells in a tumour). The authors also assumed an 80% correlation between paired observations.

As a result, at least 60 new cases would be needed to evaluate the performance of the AI tool.

Eligibility Criteria:
Inclusion Criteria:

* patients with an histological confirmation of cancer diagnosis (prostate, lung, breast, colon or rectum)
* availability of radiological images (MR for prostate and rectum, CT for lung and colon or mammographys for breast).
* enough follow up (12 months for prostate, breast and rectum), 18 months for lung, and 24 months for colon.

Exclusion Criteria:

* patients with incomplete or low quality data (radiological, pathological or uncomplete clinical data necessary for the ground truth)
Reusable Versus Disposable Duodenoscopes for ERCP

The aim of this randomized trial is to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the disposable (single-use) and reusable duodenoscopes.

Given the recent reports on infection outbreaks, including carbapenem-resistant Enterobacteriaceae (CRE), caused by contaminated duodenoscopes used at endoscopic retrograde cholangiopancreatography (ERCP), a disposable (single-use) duodenoscope (Exalt, Single-Use Duodenoscope, Boston Scientific Corporation, Natick, MA) has been developed to circumvent this issue. However, there are currently no data on the technical features and outcomes of disposable duodenoscopes, in comparison with reusable duodenoscopes.

The aim of this randomized trial is therefore to evaluate the technical aspects of disposable duodenoscopes and to compare the technical outcomes between the two duodenoscope types.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years old
2. Patients with native papilla
3. Requiring an ERCP procedure for biliary or pancreatic duct disorder, based on clinical symptoms and radiological findings at computed tomography or magnetic resonance cholangiopancreatography

Exclusion Criteria:

1. Age \<18 years old
2. Unable to obtain informed consent
3. Pregnancy
4. Altered upper gastrointestinal surgical anatomy
5. Patients with percutaneous transhepatic biliary drainage catheters
6. Prior history of ERCP
Comparison of Thawing Embryos in Advance and on the Day of Transfer on Pregnancy Outcomes in FET Cycle

Respectively for patients with repeated transplant failure and routine patients, Thawing frozen embryos in advance (18h) to extend the duration of embryonic development or thawing embryos on the day of transfer in the frozen embryo transfer cycle, to analyze which way can improve clinical pregnancy outcomes, is there a significant difference between the two ways or two types of patients?

Although in clinical practice, thawed embryos with appropriate development time will be selected strictly according to the number of days after ovulation, there are still two problems in actual clinical treatment: one is the embryonic factor, although the rate of embryonic development is generally the same, However, the phenomenon of delayed embryo division and development often occurs. The second is the endometrial factor. There are reports that a small number of people will move the transplant window forward, or the transplant window is narrow. This potentially creates the risk of embryo-endometrial mismatch. Based on this, the research team focused on patients with frozen embryo transfer cycles and put forward the strategy of "thawing embryos in advance and prolonging the development period of embryos properly" in an effort to achieve better repair of damage caused by embryo freezing and fine-tuning of embryo-endometrial interaction time. Therefore, it is necessary to compare thawing embryos in advance and thawing on the day of transfer on pregnancy outcomes in patients with repeated transplant failure and routine patients respectively.

The purpose of this study is to analyze which way can improve clinical pregnancy and birth outcomes, is there a significant difference between the two ways or two types of patients?

Eligibility Criteria:
Inclusion Criteria:

* Aged \<=35 years old;
* Regular menstrual cycle;
* Baseline follicle stimulating hormone (FSH) \<12 IU/L;
* Infertility, pure fallopian tube or/and male factor;
* At least 2 high-quality day 3 embryos or 1 high-quality day 5 blastocyst are used for ET.

Exclusion Criteria:

* Patients with repeated transplant failure:
* Abnormal uterus, such as adenomyosis, endometriosis, endometrial polyps or Asherman syndrome;
* Abnormal ovaries, such as low ovarian response and polycystic ovary syndrome (PCOS);
* The endometrial thickness of FET day is \<7 mm.
Combined Model of Online Remote Interventions for Cancer-Related Cognitive Impairment

Cancer survival rates have increased dramatically in recent years. However, many survivors report cognitive decline following treatment, which significantly impairs their quality of life. Online cognitive training programs have shown promise in improving cognitive functions in cancer survivors, but most studies report limited impact of training on everyday function. A complementary treatment approach is functional treatment delivered by occupational therapists, which directly targets daily function. Combining the two approaches has the potential to overcome the limitations of both approaches, enabling improved cognitive functions and transfer to daily function. Remotely-administrated interventions further make treatment accessible and cost-effective. The current study is aimed at testing the efficacy of a novel, combined, remotely-delivered treatment approach: Cognitive Retraining and Functional Treatment(CRAFT), using a Randomized Controlled Trial (RCT) design. 90 cancer survivors will be randomly assigned to receive 15 weeks of either the combined treatment, computerized training only, or treatment-as-usual. Outcomes will be assessed at completion, and following 3 months of no contact, to test immediate and enduring effects of treatment. Baseline predictors for treatment response will be further assessed.

Positive results in the proposed study could potentially change the therapeutic landscape for rehabilitation of cancer-related cognitive decline, which currently impair the lives of millions worldwide.


Eligibility Criteria:
Inclusion Criteria:

1. age ≥ 18;
2. Subjective concern about declines in cognitive functioning related to a diagnosis of cancer and/or cancer related treatment. This will be obtained by asking participants the question "do you have concerns about your memory or other thinking abilities following cancer treatment?". Participants are required to answer yes to this question.
3. interested in treatment and state they have 2 weekly hours available for the intervention.
4. Completion of active treatment for non-Central Nervous System (CNS) cancer (e.g., chemotherapy,radiation therapy and surgery) 6 months or more in the past.
5. Cognitive decline with no dementia: 21\<Mini-Mental State Examination \<27 (Folstein, Folstein, \& McHugh, 1975) and/or 19\< Montreal Cognitive Assessment \<26 (Nasreddine et al., 2005);
6. Daily access to a computer and Internet facilities;
7. Able to sign an informed consent;
8. Stable psychiatric condition (according to participants self- report and medical file).

Exclusion Criteria:

1. no prior experience using computers;
2. pregnancy;
3. History of a central nervous system tumor.
Ehealth: Second Life Impacts Diabetes Education & Self-Management

The purpose of this study is to to develop and evaluate the feasibility, usability, and effect of participation in SLIDES (a virtual diabetes community in Second Life) for providing interactive diabetes education, support, and resources.


Eligibility Criteria:
Inclusion Criteria:

* current Duke Endocrinology patient
* are between 21 and 75 years old
* are able to speak and read English
* are computer literate (have used a computer for at least 6 months)
* understand how to use the Internet (have accessed the Internet on at least 6 occasions)
* have access to a computer with a non-dial-up Internet connection in a private location (home)
* are mentally capable of informed consent
* are reachable by telephone
* have no pre-existing medical condition(s) or severe diabetes related complications that would interfere with study participation (i.e., physical activity) or measures (e.g., renal failure, Stage III hypertension, severe orthopedic conditions or joint replacement scheduled within 6 months, paralysis, bleeding disorders, cancer, or receipt of pharmacologic doses of anti-coagulant medications \[warfarin\])
* are able to travel to Duke University Medical Center (DUMC) for follow-up appointments.

Exclusion Criteria:

-