cyrilzakka/clinical-trials huggingface dataset:
A Study of TCR-Redirected T Cell Infusion to Prevent Hepatocellular Carcinoma Recurrence Post Liver Transplantation

Hepatocellular Carcinoma (HCC) recurrence rate is high among liver transplant patients, while treatment measures are limited. This study plans to recruit 39 subjects with Hepatitis B virus (HBV) related HCC after liver transplantation. The objective of the study is to assess the safety, tolerability and effectiveness of the HBV specific T cell receptor (HBV/TCR) redirected T cell in the target population.

A open-label, cohort clinical study of T cell receptor-redirected T cells to prevent recurrence of HBV-related hepatocellular carcinoma after liver transplantation. Subjects will be enrolled into the observation cohort or treatment cohort.

Subjects enrolled in the treatment group will receive escalating doses of HBV/ TCR expressing autologous T cells after confirming eligibility. The interval between the first two doses is 14 days, followed by one month of safety monitoring, before subsequent two doses of 1 month interval in between. Thereafter, subjects would enter into observation period of the safety and tolerability of the treatment and will be followed up until disease relapse.

Upon disease recurrence, eligible patient may receive HBV specific T-cell receptor (TCR-T) treatment.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis as hepatocellular carcinoma (HCC)
* Underwent liver transplantation
* Seropositive for hepatitis B surface antigen (HBsAg), or presence of HBV DNA or HBV RNA before liver transplantation
* Expression of TCR-T target epitopes within specific human leukocyte antigen (HLA) class I profile
* No major post-operative complication
* Life expectancy of at least 3 months
* Ability to provide informed consent
* Ability to comply with study procedures

Exclusion Criteria:

* Known, clinically suspected or has history or central nervous system (CNS) and bone metastasis
* Significant ongoing immunologic rejection based on pathology and clinical diagnosis
* Evidence or history of significant bleeding diathesis or coagulopathy
* Prior exposure to any cell therapy such as, but not limited to NK, CIK, DC, CTL, stem cells therapy
* Known history of testing positive for human immunodeficiency virus (HIV) 1 or 2 or known acquired immunodeficiency syndrome (AIDS)
* Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection
* Women who are pregnant or breast-feeding
* Any condition that is unstable or which could jeopardise the safety of the patient and his/her compliance in the study
Quantitative Evaluation of Attention to Faces After Orthognathic Surgery With Eye-tracking

Dentofacial deformities refer to morphological anomalies of the jaws. Their development during growth determines the shape of the lower third of the face and the type of dental occlusion. A maxillo-mandibular dysmorphosis associates morphological modification of the face and anomaly of the occlusion. If these anomalies are most often hereditary, they also depend on acquired factors such as swallowing, breathing, sucking or phonation disorders. Angle's classification defines three classes of dental occlusion: class I, when the ratio between the maxillary and mandibular first molars is normal, class II when the upper molar is too far forward, and class III when it is too far back. Class II and III dysmorphoses can result in an alteration of the masticatory function, pain (TMJ, headaches) or sleep apnea. At the same time, they cause patients to experience a decrease in self-esteem, anxiety and social discomfort. Class II and II usually require orthodontic treatment and orthognathic surgery to correctly align the jaws. This surgery has a positive impact on the dental occlusion and the functions concerned, but also on the facial morphology, all of which often leads to an improvement in the patient's quality of life.

Standardized photographs presenting control subjects (class I) and patients (class II and class III) before and after surgery will be included in an approximately 10 min video sequence. Naive participants will look at this sequence during which the faces of the controls and the patients - before and after surgery - will alternate, with the instruction being free visual exploration of the images. The total fixation durations in defined areas of interest (eyes, nose, mouth, chin) will be recorded with an eye tracking device and the results will be processed using a dedicated software.


Eligibility Criteria:
Inclusion Criteria:

* Naïve subject with regard to dentofacial deformities and their management
* Subject with no known facial pathology
* Subject having provided an informed consent
* Subject \> 18 years old

Exclusion Criteria:

* Subject familiar with dentofacial deformities and their management (e.g., health professionals in the relevant specialties)
* Subject with known facial pathology (dentofacial deformity or other)
* Subject under guardianship, curators or justice protection
Liraglutide and Peripheral Artery Disease

STARDUST is an open-label, two-arm randomized controlled trial, aimed at evaluating the effects of liraglutide on peripheral perfusion, as compared with the aggressive treatment of cardio-metabolic risk factors, in people with type 2 diabetes and peripheral artery disease. The potential benefits for participants in the study include the possibility of improving peripheral perfusion with drugs that have been evaluated as effective in controlling diabetes and safe and protective for cardiovascular health.

The primary outcome of the study is the change of peripheral transcutaneous oxygen tension between groups at three and six months. Participants in the study will be followed for 6 months in order to evaluate the effects of liraglutide and the change of other secondary outcomes.

An 18-month extension of the follow-up will be performed for all the study population, according to guidelines and good clinical practice. The follow-up will include the glyco-metabolic parameters and the main cardiovascular risk factors, including TcPO2 assessment.

Data from this extended observation will be collected for additional analyses (mostly regarding the durability of the effects). Individuals who will be lost during follow-up and/or discontinue or modify the glucose-lowering treatment will be excluded from the analyses.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of type 2 diabetes within at least 6 months
* peripheral arterial disease documented within al least 1 year by doppler ultrasound, angio-CT or arteriography
* peripheral transcutaneous oxygen pressure between 30 and 49 mmHg on anterior and/or posterior tibial arteries
* Hba1c 6,5-8%
* treatment of diabetes with metformin, insulin and/or sulfonylurea

Exclusion Criteria:

* diagnosis of type 1 diabetes
* current treatment with GLP-1 receptor agonists (GLP-1RAs) or dipeptidyl peptidase -4 (DPP-4) inhibitors
* GLP-1RAs allergy or intolerance
* participation to other clinical studies
* history of pancreatitis, thyroid disease, diabetic gastroparesis or inflammatory bowel disease
* current or planned pregnancy
* acute myocardial infarction and/or acute cerebrovascular disease within 14 days from the screening visit
* planned revascularization procedure
* renal function with estimated glomerular filtration rate (eGFR) below 15 ml/min
* history of cancer and/or oncological treatment within 5 years from the screening visit
* current treatment with corticosteroids
* psychiatric or other clinical conditions which may interfere with the study
Low Dose of Cannabidiol (CBD) to Treat Mild to Moderate Musculoskeletal Pain

The purpose of the study is to evaluate whether Pure Green tablets is a better pain reliever for the treatment of mild to moderate musculoskeletal pain.


Eligibility Criteria:
Inclusion Criteria:

1. Male or female at least 21 years of age;
2. Subject has mild to moderate musculoskeletal pain;
3. Pain for greater than or equal to 10 days of each month for 3 months prior to study entry for which the pain requires treatment.
4. Has an Numeric Pain Rating Scale (NPRS) score of 3 or greater,
5. If female, subject is practicing an approved method of birth control throughout the study;
6. Subject is willing and able to comply with all protocol-specified requirements;
7. Subject is willing to take Pure Green tablets only and will not take any other pain medications,
8. Subject is willing to provide his/her written informed consent to participate in the study as stated in the informed consent document.
9. Subject is willing to document pain scale scores in a diary.

Exclusion Criteria:

1. Subject has any condition for which the investigator does not feel the participant should be enrolled due to possible safety or compliance issues;
2. Subject has received treatment with an investigational drug or therapy within 30 days or 5 half-lives (whichever is longer) prior to Day 1.
3. Subject has a known allergy to active or inert ingredients of Pure Green tablets;
4. Subject is taking a concomitant medication or treatment that would complicate use or interpretation of the study drug's effects (examples include: Cannabis (marijuana) or any cannabinoid products including Cannabidiol (CBD) or Tetrahydrocannabinol (THC); Any drug or herbal product that influences the endocannabinoid system (ECS));
5. Have serious cardiovascular, hepatic, renal, respiratory, or hematologic illness, or other medical or psychiatric condition that, in the opinion of the investigator, would compromise participation or be likely to lead to hospitalization during the course of the study.
6. Have a history of recurrent seizures other than febrile seizures.
7. Have current or pending disability compensation or litigation issues that may compromise response to treatment, in the opinion of the investigator.
8. Have a diagnosis of inflammatory arthritis (that is, rheumatoid arthritis) or an autoimmune disorder (excluding inactive Hashimoto's thyroiditis).
9. Use of acupuncture, chiropractic maneuvers, transcutaneous electrical nerve stimulation (TENS), or similar procedures aimed to relieve any kind of pain.
10. Patients who are anticipated by the investigator to require use of analgesic agents including but not limited to non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen/paracetamol, and opioids, or other excluded medication for the duration of the study.
11. Are unwilling or unable to comply with the data collection method used to record their patient rated outcome data.
Noninvasive Screening for Fetal Aneuploidy: A New Maternal Plasma Marker

The purpose of this study is to collect samples for the purpose of developing a prenatal aneuploid test using circulating cell free fetal (ccff) nucleic acid from blood samples from pregnant women who have a high-risk pregnancy undergoing invasive prenatal diagnosis by chorionic villus sampling (CVS) and/or genetic amniocentesis. The results of the ccff aneuploid test will be compared to the chromosomal analysis obtained via CVS or amniocentesis.


Eligibility Criteria:
Inclusion Criteria:

* Subject is female
* Subject is pregnant
* Subject is 18 years of age or older
* Subject provides a signed and dated informed consent
* Subject agrees to provide a 30-50mL blood sample
* Subject is at increased risk for Down syndrome or other aneuploidies (greater than or equal to 35 years of age at time of delivery, elevated risk by maternal serum markers including Triple, Quad and integrated test, fetal birth defects or markers identified by ultrasound or family history of aneuploidy).
* Subject plans to undergo an amniocentesis and/or CVS procedure
* Subject agrees that the FISH, karyotype, and/or QF-PCR results obtained via the invasive procedure will be provided

Exclusion Criteria:

* None
Prognostic Value of PD-L1 in NSCLC

This is an observational retrospective study. The primary objective is to investigate the expression and potential prognostic role of Programmed Death Ligand 1 (PD-L1) in tumor samples from 350 patients with early stage treatment-naive non-small-cell lung cancer (NSCLC).

Tissue samples were embedded in a tissue microarray. PD-L1 will be studied by immunohistochemistry using the SP263 antibody. Stained samples will be evaluated independently by two operators. A tumor will be defined as positive when = or \>50% of tumor cells express the ligand.

The investigators will investigate the relationship between PD-L1 protein expression and overall survival and other clinical characteristics with appropriate statistical methods.


Eligibility Criteria:
Inclusion Criteria:

* Early stage treatment-naive NSCLC

Exclusion Criteria:

* Received any pre-surgical treatment
* no OS data available
The Prevalence of Malocclusion Development in a Group of Egyptian Children With Digit Sucking Aged 3 to 6 Years

The purpose of the study is to determine the prevalence of malocclusion among a group of Egyptian children with digit sucking aged 3 to 6 years.

The purpose of the study is to determine the prevalence of malocclusion among a group of Egyptian children with digit sucking aged 3 to 6 years.

PICO:

Population: Egyptian Children with digit sucking aged 3 to 6 years. Outcome: Development of malocclusion.

Eligibility Criteria:
Inclusion Criteria:

* Children between ages 3 to 6 years.
* Children those are medically free.
* Both genders are included.
* Egyptian children

Exclusion Criteria:

* History of an obvious alternative cause for malocclusion (e.g. trauma, syndromes).
* Participants exposed to thumb sucking prevention programs.
* Participants who underwent orthodontic treatment for his/her malocclusion.
* Participants' caregivers refuse to give consent.
Clinical Study on the Effect of Probiotic Compound Powder on the Immunity Improvement of Preschool Children

This is a randomized controlled trial, to evaluate the effect of WONDERLAB Probiotic Compound Powder on improving immunity of preschool children

The community hospital will recruit 140 preschool children, aged 5 to 6 years old, according to the inclusion and exclusion criteria, and randomly assigned them to 2 groups. 70 subjects in the placebo group and 70 in the experimental product group.

First entered a one-week washout period, and then entered a 25-week clinical intervention, and finally ensured that 100 volunteers completed the whole study, and the withdrawal rate was about 28%.

Eligibility Criteria:
Inclusion Criteria:

* Preschool children, male or female, 5 to 6 years old;
* Those with weak constitution and easy to get sick:

One of them can be satisfied:

AGet cold ≥ 3 times a year B Bronchitis or pneumonia ≥2 times per year C Rotavirus diarrhea ≥1 time per year

* During the trial, participants agree not to take any drugs, supplements, or other dairy products containing probiotics;
* During the trial, participants agree not to take any other prebiotic/bacterial drugs, supplements, or dairy products including yogurt drinks;
* Willing to refrain from participating in other interventional clinical studies during the trial period;
* Be able to fully understand the nature, purpose, benefits and possible risks and side effects of the research;
* Willing to obey all test requirements and procedures;
* Informed consent signed by parents or legal guardians.

Exclusion Criteria:

* Subject who is in the treatment of gastrointestinal diseases;
* Subject who has lactose intolerance;
* The subjects are currently suffering from other organic diseases that affect intestinal function, such as history of gastrointestinal resection, colonic or rectal cancer, inflammatory bowel disease, diabetes, hyperthyroidism or hypothyroidism, Hirschsprung's disease, scleroderma, anorexia nervosa, etc.;
* Subjects have any of the following medical histories or clinically diagnosed diseases that may affect the evaluation of the test effect: obvious gastrointestinal dysfunction, liver, kidney, endocrine, blood, respiratory and cardiovascular diseases;
* According to the judgment of the researchers, frequent use of drugs that may affect gastrointestinal function or the immune system;
* Subjects who took laxatives or other digestive aids 2 weeks before the start of the study;
* Consumed dairy products or other foods containing prebiotics/bacteria within 10 days before the start of the study;
* PI believes that volunteers cannot fully cooperate with the trial arrangement.
Study Evaluating The SBI-087 In Subjects With Systemic Lupus Erythematosus

The purpose of this study is to determine the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of SBI-087 in subjects with Systemic Lupus Erythematosus (SLE).


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of SLE (by greater than or equal to 4 American College of Rheumatology \[ACR\] Revised Criteria) greater than 6 months before study day 1.
* History of a positive antinuclear antibody (ANA) titer greater than or equal to 1:160 or equivalent.

Exclusion Criteria:

* Treatment with more than 20 mg of prednisone per day.
* Evidence of unstable clinically significant disease (e.g., cardiovascular, cerebrovascular, respiratory, or renal disease, or any other unstable serious disorder) other than SLE.
* History of cancer (other than resected cutaneous basal and squamous cell carcinoma or in situ cervical cancer) with less than 5 years' documentation of a disease-free state.
The High Cup/Disc Ratio in Children

To investigate of high cup/disc ratio in children.

ophthalmologic examination

1. cycloplegic refraction
2. axial length and anterior chamber depth
3. intraocular pressure

B. optic nerve head and retinal nerve fiber layer

1. disc photography
2. Heidelberg Retina Tomograph

Eligibility Criteria:
Inclusion Criteria:

* high cup/disc ratio more than 0.5
* age : five to twelve

Exclusion Criteria:

* previous surgery (except strabismus surgery) previous glaucomatous medication history poor cooperated children.
The Effects of Remifentanil on Attenuating the Hemodynamic Responses After Electroconvulsive Therapy

The investigators will be evaluated the effects of a single loading dose of remifentanil (1µg/kg), administered as an adjunct to sevoflurane, on duration of hemodynamic profile, seizure activity, and recovery times during electroconvulsive therapy (ECT) in patients with major depression

Major depressive patients will enrolled this trial. Mean arterial pressure (MAP) and heart rate (HR) and peripheral oxygen saturation values will be recorded prior to anesthetic induction (T1); following anesthetic induction (T2); and 0, 1, 3, and 10 minute after the seizure have ended (T3, T4, T5, and T6, respectively). The peak heart rate during the seizure will be recorded from the Electrocardiogram.

Eligibility Criteria:
Inclusion Criteria:

* Major depressive patients

Exclusion Criteria:

* younger than 18 years, pregnant, had a history of myocardial infarction in the previous six months, atrial fibrillation or flutter, heart block, unregulated hypertension, cerebrovascular diseases, known drug allergy.
Cisplatin and Gemcitabine in Treating Patients With Advanced Squamous Cell Cancer of the Head and Neck

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells.

PURPOSE: Phase I/II trial to study the effectiveness of cisplatin and gemcitabine in treating patients with advanced squamous cell cancer of the head and neck that cannot be surgically removed.

OBJECTIVES: I. Determine the maximum tolerated dose and dose limiting toxicity of gemcitabine used in combination with cisplatin in the treatment of squamous cell carcinoma of the head and neck. II. Determine the toxicity profile of this combination treatment in these patients. III. Assess the response rate of treatment in these patients.

OUTLINE: This is a dose escalation study of gemcitabine. Patients receive gemcitabine as an IV bolus on day 1 every 2 weeks. Cisplatin is administered on day 1 every 2 weeks. In the absence of dose limiting toxicity (DLT) in the first 3 patients treated, subsequent cohorts of 3 patients each receive escalating doses of gemcitabine on the same schedule. If 1 of 3 patients in each cohort experiences DLT, an additional 3 patients are enrolled at that same dose level. If 2 of 3 patients experiences DLT in the cohort, then dose escalation ceases and the next lower dose is declared the maximum tolerated dose. Patients are assessed for response every 2 weeks. Patients may continue treatment for up to 9 months or until disease progression.

PROJECTED ACCRUAL: At least 3 patients will be accrued for phase I and 20-40 patients will be accrued for phase II of this study.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically proven stage III or IV squamous cell carcinoma of the head and neck that is surgically unresectable and not curable by radiation therapy Upper aerodigestive tract only Unresectable or recurrent disease following initial therapy with surgery and/or radiation Measurable or evaluable disease

PATIENT CHARACTERISTICS: Age: Over 18 Performance status: SWOG 0-2 Life expectancy: Not specified Hematopoietic: Not specified Hepatic: Bilirubin no greater than 3 times institutional normal Transaminases no greater than 3 times institutional normal Renal: Creatinine clearance greater than 40 mL/min Cardiovascular: Adequate cardiac function No heart failure Pulmonary: Adequate pulmonary function not requiring supplemental oxygen Other: Not pregnant Fertile patients must use adequate contraception

PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: Not specified Endocrine therapy: Not specified Radiotherapy: Prior radiation therapy allowed Surgery: Prior surgery allowed
Function-oriented Assistive Technology Indexing System Development and Promotion

Appropriate assistive devices are important factors for the activity participation of the disabled. These devices should be prescribed by the specialists based on their functional needs. However, most individuals in need of assistive devices locate in the household, school, or nursing institute, in which the professional interventions are not always available on demand. Consequently most assistive devices are used without thorough evaluation, therefore do not necessarily meet the exact needs of the individual. Hence an easy-to-access and easy-to-use assistive technology device indexing system based on the functional needs of the subjects is necessary. The goals of this two-year study are twofold: assistive technology indexing system application(APP) development and promotion. First, the multidisciplinary research team, composed of specialists from assistive technology, rehabilitation, computer science, and special education fields, is going to integrate and refine the current resources and develop an assistive technology indexing system App based on the functional needs of the disabled. Second, in cooperation with the disabled community and special schools, the team is going to promote the use of the App and evaluate its usability via System Usability Scale. This App will be beneficial to the individuals in need of assistive device application. It can also be used as an assistive device manual for the specialists. The App will guide the individuals step by step to the proper assistive devices based on their functional capacities. The complete system will include details of each assistive device and link up with the related service resources. With its registering function, the statistics collected via user clicks can serve as references for further design adjustments and assistive device related policy modifications. All together this App can provide comprehensive services to the disabled in need of assistive devices.


Eligibility Criteria:
Inclusion Criteria:

Caregivers:

1. ages ranged from 20 to 60 years old,
2. serves as the primary caregiver of the disabled in school and organization settings,
3. minimum 6 months caring experience, at least 10 hours direct contact with the client per week.

People with disabilities:

1. ages ranged from 20 to 60 years old,
2. experienced with assistive devices use at least for 1 year,

Exclusion criteria:

* Any visual or motor problems that restrain the use of a smart phone.