cyrilzakka/clinical-trials huggingface dataset:
Study of LD013 in Subjects With Refractory or Relapsed Mesothelin -Positive Ovarian Cancer

Early-stage Clinical Study of mesothelin-specific Chimericantigen Receptor T Cells (LD013) in Subjects With Refractory or Relapsed mesothelin-positive Ovarian Cancer

This is a single-arm, open, dose-increasing, and extended early-stage clinical study of mesothin-specific chimeric antigen receptor T cells (LD013) in patients with mesothelin-positive drug-resistant relapsed ovarian cancer. This study included two phases: dose escalation and extension.

Eligibility Criteria:
Inclusion Criteria:

Fully understand and voluntarily sign informed consent.

* Aged at least 18 years old，female.
* Expected survival \> 12weeks.
* Eastern Cooperative Oncology Group (ECOG) score 0or1.
* Staining of mesothelin must be greater than 50% of the cells in the tumor tissue and with apparent expression in the membrane. Tissue obtained for the biopsy must be ≤2year prior to enrollment for screening, not have been previously irradiated or exposed to chemotherapy. If unavailable, new tissue material from a recently obtained surgical or diagnostic biopsy is mandatory for this trial；

Exclusion Criteria:

* Prior treatment with any CART therapy targeting any target.
* Subjects with severe mental disorders.
* Subjects with other malignant tumors.
* Patient is positive for Syphilis, Human Immunodeficiency Virus (HIV) , active Hepatitis B (HBsAg reactive) or Hepatitis C (HCV RNA (qualitative) is detected).
* Detectable clinically relevant central nervous system (CNS) metastases and/or pathology such as epilepsy/seizure, brain Ischemia/ hemorrhage, dementia, cerebellar disease, or autoimmune disease affecting central nervous system；
* Patients with ongoing or active infection.
* Subjects not appropriate to participate in this clinical study judged by investigators.
Purified Inactivated Japanese Encephalitis Vaccine

This study evaluates the immunogenicity and safety of a purified inactivated JE vaccine compared to a commercialized JE vaccine. In this phase III, randomized, blind trial, infants at 6-23 months of age were randomly assigned to three groups to receive experimental vaccine or control vaccine with two different vaccination schedule respectively.

The clinical study used randomized, blind method, commercialize inactivated Japanese encephalitis vaccine as control. In Infants at 6-23 months of age were injected with experimental vaccine with 0,7 days and 0,28 days vaccination schedule to evaluate immunogenicity and safety of the experimental vaccine and the effectiveness of different vaccination schedule. Participates were assigned to three groups (350 per group): group 1 with experimental vaccine using 0,7 days vaccination schedule; group 2 with control vaccine using 0, 7 days vaccination schedule; group 3 with experimental vaccine using 0, 28 vaccination schedule.

Blood samples were collected before immunization and 30 days after immunization, and the neutralization antibody of Japanese encephalitis was detected by plaque reduction neutralization test. Medical observation was conducted 30 minutes after each injection. Body temperature of participates was continuously measured for 7 days, and any adverse events were observed and recorded from the first dose to 30 days after the whole vaccination. Serious adverse events were collected within 6 months after the first dose.

Eligibility Criteria:
Inclusion Criteria:

* 6-23 months old infants, no vaccination history of JE vaccine, no vaccination contraindication.
* informed consent of guardian / lawful written guardian, and signed informed consent;
* the guardian and family can comply with the requirements of the clinical trial scheme.
* there was no immunization history of immunoglobulins within three months, and there was no history of live vaccination within 14 days.
* the axillary temperature ≤ 37℃.

Exclusion Criteria:

* Allergy to any ingredient in the vaccine (any previous history of vaccine allergy); There are allergic, convulsive, epileptic, encephalopathy and psychiatric symptoms or signs.
* People with known or suspected (or high-risk) impairment or abnormality of immune function, such as those receiving immunosuppressive or immunopotentiator therapy, receiving blood products or plasma extracts within three months, or having an immunodeficiency virus infection or related disease in the mother or child.
* A history of thrombocytopenia or other coagulation disorders clearly diagnosed by the medical department, or a history of hemorrhagic constitution or prolonged bleeding time;
* Infected patients with known or suspected to have respiratory diseases, acute infections or active chronic diseases and are receiving antibiotic or antiviral treatment;
* In the past 3 days, fever (axillary body temperature≥38℃), oral or steroid hormones were given.
* Infectious or allergic skin diseases.
* Participating in another clinical researcher; or any situation that the researcher considers likely to affect the evaluation of the trial
Study of Atorvastatin Versus Placebo to Reduce Cardiopulmonary Complications After Thoracic Surgery

This study will compare atorvastatin (Lipitor) with a placebo (inactive pill) to see if this drug reduces heart rhythm abnormalities (arrhythmias) or lung inflammation after thoracic surgery. Preliminary results suggest that cholesterol lowering drugs (statins) may reduce problems after surgery such as arrhythmias or lung inflammation which may be serious. This study will be randomized and double blind, meaning that patients are placed in groups purely by chance, like flipping a coin. Neither the patient or doctor will know which group the patient is in.

Hypothesis: Statins attenuate perioperative inflammatory and oxidative mechanisms that contribute to the initiation and severity of cardiopulmonary complications after thoracic surgery.

Aim 1. To determine whether prophylactic administration of atorvastatin attenuates the inflammatory and oxidative response to surgery and significantly reduces the composite risk of cardiovascular morbidity (atrial fibrillation (AF), acute coronary syndrome, myocardial infarction (MI), cerebrovascular accident (CVA), pulmonary embolism) and mortality within 30 days after thoracic surgery.

Aim 2. To explore whether prophylactic administration of atorvastatin attenuates the inflammatory and oxidative (CRP, IL-6, TNF, and MPO) response to surgery and significantly reduces the overall risk of pulmonary complications (atelectasis, pneumonia, pneumonitis, acute respiratory failure) after thoracic surgery.

Aim 3. To explore the association of single nucleotide polymorphism (SNP) changes in genes linked to atrial fibrillation and inflammatory markers and development of pulmonary morbidity after thoracic surgery.

Aim 4. To explore whether an imbalance between metalloproteinase (MMP)-1 and its inhibitor (TIMP) is associated with postoperative atrial fibrillation risk and/or development of pulmonary morbidity after thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients ≥ 18 yr. scheduled for anatomic lung resection (segmentectomy, lingulectomy, possible or definite lobectomy, bilobectomy, pneumonectomy or extrapleural pneumonectomy) with or without chest wall resection or limited resection
* Patients with regular cardiac rhythm
* Patients able to take oral capsules
* Patients capable of providing written, informed consent
* Patients without known hepatic or kidney disease

Exclusion Criteria:

* Patients already taking any statin, gemfibrozil (Lopid), or ezetimibe (Zetia)
* Hypersensitivity to atorvastatin
* Chronic atrial fibrillation
* Patients already taking class Ic or III antiarrhythmic drugs
* Known pregnancy a urine pregnancy test will be given to women of childbearing age
* Known history of active hepatic disease or known hepatic insufficiency
* Known history of active kidney disease or insufficiency
SCOPE and Special Olympics

The purpose of this study is to examine if Special Olympic athletes's life participation improves through involvement with Special Olympics. This project will be undertaken in coordination with Special Olympics entities from Texas and around the nation to determine how involvement in Special Olympics improves the strengths and limitations of their athletes. The Short Child Occupational Profile (SCOPE) will be used to gather this information from the parents and coaches. The SCOPE measures the impact that personal and environmental factors have on a child or youth's occupational participation.

The research team members will not have contact with the Special Olympic athletes. Parents and coaches will be the only individuals who have contact with the athletes. Participants will be assured that their participation is completely voluntary. If they agree to participate in the research an informed assest form will be explained by a parent, guardian, or coach and they will be asked to sign it. Parents will be asked to sign a consent form for their child's participation in the study. Coaches will administer the SCOPE as a pre/post-test outcome measure. Parents will submit the Parent form of the SCOPE and the coaches will submit the SCOPE Clinical Data Summary Form. All data will be de-identified and sent in form the coaches. The TWU special olympics research team will compile de-identified data from a pre-test and post-test utilizing the SCOPE. A codebook that links the ID number with the participants will be kept by the coaches. The research team may be able to trace assented data collected through the TWU data collection protocol back to the coaches. Participating athletes will not be contacted by the PI and no contact information will be collected. In the case of an unexpected or adverse event, or if the participants request to be contacted, attempts may be made to find the subjects contact information through the coaches. De-identified data collected by the TWU Special Olympic research team or other Key Research personnel will be stored on a password protected computer or in a locked file cabinet in a locked office in the department of occupational therapy at Texas Woman's University in Houston. The raw data collected will not be made available to anyone other than the PI and immediate study research personnel. Data is entered into the database using the ID number, and the computer database is password protected. The raw data is not going to be shared. The data will be kept in a locked file cabinet within the research office of the databases destroyed 4 years after the end of the study. The results of the analysis, which may include information from the data, will be kept on a password secure computer indefinitely. The data collected from pre-tests and post-tests will then be compiled and analyzed.

Eligibility Criteria:
Inclusion Criteria:

* new members (within 2 years),
* English-speaking,
* U.S. citizens, and
* must be 7 years or older at the time of assess.
Cognitive Behavioural Therapy for Children With Autism Spectrum Disorder and Obsessive Compulsive Behaviour

Individuals with high functioning autism spectrum disorder (ASD) frequently experience obsessions and/or compulsions that are similar to those specified in Diagnostic and Statistical Manual of Mental Disorders (5th ed.; DSM-5) criteria for obsessive compulsive disorder (OCD). However, little research exists on effective interventions for OCD symptoms (referred to as OCBs) in ASD. In a randomized controlled trial, a manualized functional behavior-based cognitive-behavior therapy (Fb-CBT) consisting of traditional CBT components (psychoeducation and mapping, cognitive-behavioral skills training, exposure, and response prevention) as well as function-based behavioral assessment will be evaluated. Participants will be assigned randomly to Fb-CBT or treatment as usual (TAU). Primary and secondary outcome measures will be used to evaluate the efficacy of the treatment, and will be administered at pre and post-intervention as well as six month follow-up.


Eligibility Criteria:
Inclusion Criteria:

* Previous diagnosis of ASD
* Presence of OCBs as defined by Sameness, Ritualistic and Compulsive subscales on the RBS-R
* a Full Scale IQ (WISC-IV; Wechsler, 2004) ≥ 70
* parent indicated no planned change in child medication during the study (unless the physician deemed the change medically necessary)

Exclusion Criteria:

* participation in treatment for anxiety
* participation in treatment for repetitive behaviour
* participation in treatment for intensive behavioural intervention
Prediction of Gastric Cancer in Intestinal Metaplasia and Atrophic Gastritis

The primary objectives of this study are:

* To identify clinical or histological factors associated with gastric cancer development in patients with IM and AG
* To establish a machine learning algorithm for prediction of future gastric cancer risks and individual risk stratification in patient with IM and AG

This is a two-part retrospective study including a clinical data part and a pathology part. A training cohort will be developed from approximately 70% of included cases. It will be followed by a validation cohort with the remaining cases.

Clinical data will be collected retrospectively using the Clinical Data Analysis and Reporting System (CDARS) and Clinical management System (CMS). A cluster-wide cohort (New Territories East Cluster, NTEC) consisting of patients with history of histologically-proven gastric IM and AG will be identified and included for subsequent analysis. The data collection period for the retrospective data will be 2000-2020.

Histology slides will be retrieved retrospectively when available (within NTEC). Whole slide imaging technique will be utilized for the development of training and validation cohorts with machine learning algorithms in the pathology part.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>= 18 years of age
* Histologically proven atrophic gastritis or intestinal metaplasia (at antrum and/or body and/or angular of stomach)

Exclusion Criteria:

- none
Development and Validation of Pelvi-Fit App

Urinary incontinence (UI) is defined as involuntary urinary leakage or inability to control urine. Various physiological changes during pregnancy, including collagen changes, hormonal changes, and increased uterine and fetal weight, contribute to the weakening of the pelvic floor muscles (PFMs) during pregnancy. Approximately, 42% of women experience their first UI during pregnancy, and up to 31% of parous women have UI. Women with persistent UI after delivery may continue to experience UI for another 12 years. Therefore, UI during pregnancy may be an essential risk factor for subsequent UI among women. This Study will result in a product called Pelvi-Fit app that will help patients to self-treat their Pelvic Floor disorders in a way that is approved by medical experts. It will allow the patient to train their pelvic floor muscles independently who are not able to get medical assistance due to being in remote areas or any other reason.

Literature suggests that UI is troublesome, affects women's quality of life physically, emotionally, spiritually, and financially. Those who experience it may resort to various methods to deal with the problem, including using pads or incontinence diapers and avoiding social situations because of embarrassment. However, many women do not seek help despite having UI symptoms because of the perception of UI as embarrassment to initiate a discussion about UI with their health care provider. Some are unaware of treatment availability, such as PFM training (PFMT), whereas others feel they should not disturb their health care provider as UI is a temporary issue. Developing a positive attitude is essential to enable people to change their behavior successfully. The use of persuasive technology (PT) in mHealth apps may support attitude and behavior change in users to adopt PFMT as part of their lifestyle. The pre-final version of Pevi-Fit app will be made in this study. The control group will receive the validated content-based treatment protocol of UI in descriptive form and the experiment group will receive the same treatment of UI through pre-final version of the Pelvi-Fit app. The results of both groups will be recorded and compared to assess the effectiveness of using technological methods in the treatment of patients with Urinary Incontinence

Eligibility Criteria:
Inclusion Criteria:

* Females of child-bearing age up to 65 years of age having Urinary Incontinence.
* Females having Cognitive ability to use the Pelvi-Fit App, screened through MMSE tool (Average score \>25).

Exclusion Criteria

* Patients of neurological conditions; SCI, Stroke.
* Not friendly to use mobile apps.
Application of PREVENA in Reducing Surgical Site Complications Following Reversal of Ileostomy or Colostomy

Surgical site infections (SSI) remain one of the most common complications associated with reversal of ileostomy and colostomy. In addition to having detrimental impacts on the patient's post-operative course, they also pose significant financial ramifications.

There have been comparative studies in the use of negative pressure wound therapy in reducing surgical site infections.

PREVENA Incision Management System is a type of disposable, customizable and powered negative pressure system designed to help manage and protect surgical incisions and their surrounding environment. It is now commonly used as a surgical wound dressings in the setting of vascular surgeries, post-cesarean infections and colorectal resections.

Our study is designed as a randomised controlled trial to examine if PREVERA therapy as a NPWT is more superior than conventional dressings in reducing the rate of surgical site infections.

Background:

Surgical site infections (SSI) remain one of the most common complications associated with reversal of ileostomy. In addition to having detrimental impacts on the patient's post-operative course, they also pose significant financial ramifications.

The use of Negative Pressure Wound Therapy (NPWT) is one strategy that has been extensively studied in reducing the rate of surgical site infections.

PREVENA Therapy is a form of Incisional Negative Pressure Wound Therapy (INPWT) that has been widely used in the management of closed surgical incisions. They are delivered as prophylactic measures in preventing surgical complications such as surgical site infections.

Trial Design:

This study is designed as a randomized, controlled, open-label, multi-center superiority trial with 2 parallel groups and primary endpoint of surgical site infection at day 7 (after 7-day use of PREVENA) and day 30.

Study Setting The trial will be conducted at two different hospitals located in Dublin, Ireland: St James Hospital - Ireland's largest acute academic teaching hospital (Academic Partner - Trinity College Dublin); Tallaght University Hospital - (Academic Partner - Trinity College Dublin)

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years old
* Patients undergoing elective reversal of ileostomy/colostomy
* Patients who agree to consent to inclusion and follow-up protocol

Exclusion Criteria:

* Patients who do not fulfil study protocol
* Dressings being removed outside defined time periods
* Patients who do not attend for regular outpatient follow up appointments
Deep Brain Stimulation (DBS) Data Base Study

The primary goal of this study is to evaluate and compare outcomes, trends, and effectiveness of both awake and asleep Deep Brain Stimulation (DBS) surgical treatments, target selection, targeting accuracy and outcomes in patients with Parkinson's disease and Essential tremor.

Deep Brain Stimulation (DBS) surgery is a treatment that can improve some of the motor symptoms associated with several movement disorder diseases. DBS is recommended for patients with Parkinson's disease who respond well to medication, but still experience frequent wearing off of medications with return of symptoms. Patients may also be experiencing troubling medication side effects such as dyskinesias, sleepiness, hallucinations, confusion, and behavioral/personality changes. DBS is also used for patients with Essential tremor who have undergone long trials of medication therapy and are still symptomatic. The goal of DBS surgery is to capture that best response to medication and hold it through the day. The Food and Drug Administration (FDA) approved DBS as a treatment for essential tremor in 1997 and for Parkinson's disease in 2002.

The goal of DBS surgery is to improve the quality of life of patients and their families by reducing motor symptoms such as slowness, stiffness and tremor and possibly reducing medication. In order to help with our understanding of its effects, we will collect information on patients who will be undergoing or have undergone DBS surgery.

St. Joseph's Hospital and Medical Center / Barrow Neurological Institute is one of only a few hospitals in the United States offering a new procedure known as asleep DBS surgery, performed under general anesthesia, as well as the traditional awake DBS procedure; therefore it is important that this new asleep surgery option be studied and compared to awake DBS surgery.

Objectives include:

* Comparison of data collected for both the awake and asleep DBS procedures during the pre-operative and post-operative periods including testing, diagnosis, surgical treatment, target accuracy, complications, motor function and quality of life outcomes.
* Comparison of the differential effects of STN and GPi DBS on gait and balance control
* Investigate the effects of DBS on the saccadic eye movements.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis for Parkinson's Disease or Essential Tremor
* Subject has undergone DBS surgery

Exclusion Criteria:

* Clinical diagnosis for Parkinson's Disease or Essential Tremor
* Subject has not undergone DBS surgery
Effect of the Genotype on Postoperative DVT

Postoperative Venous Thromboembolism Events (VTE) constitute a major source of morbidity and mortality after surgery. The aim of this study was to investigate whether commonly occurring Single Nucleotide Polymorphisms (SNPs) are associated with VTE in the surgical setting.

Data extracted from the participants in the UK Biobank collaborative study. Two cohorts will be examined:

1. Surgical cohort, consisting of all patients with a registered surgical procedure in the UK biobank repository
2. Validation cohort, consisting of all non-surgical patients in the UK biobank repository.

A GWAS approach will be used to associated commonly occurring single nucleotide polymorphisms (SNPs) with a postoperative venous thromboembolic event (VTE) within 30 days of a surgical procedure in the surgical cohort.

Findings from the surgical GWAS step will be replicated in the Validation cohort in order to assess whether the same SNPs drive both surgical and non-surgical VTE risk.

A final GWAS model will be fielded, correction for confounders including sex, age, smoking, obesity and open/minimal invasive surgery (surgical discovery GWAS only).

Eligibility Criteria:
Inclusion Criteria:

- All patients included in the UK biobank repository

Exclusion criteria:

- None