cyrilzakka/clinical-trials huggingface dataset:
A Study to Assess CLBR001+SWI019 in Subjects With Autoimmune Diseases

The goal of this clinical trial is to evaluate CLBR001 and SWI019 as a treatment for patients with autoimmune disorders, including systemic lupus erythematosus, systemic sclerosis, and idiopathic inflammatory myositis. Patients will be randomized 1:1 lymphodepletion vs no lymphodepletion arm. Patients will be administered a single infusion of CLBR001 cells followed by cycles of SWI019 with regular assessments of safety and disease response to treatment.

The goals are to establish the safety and efficacy of the combination therapy and determine if lymphodepletion is required for efficacy.

CLBR001 + SWI019 is novel switchable CAR-T cell combination therapy comprised of an autologous CAR (chimeric antigen receptor)-T product (CLBR001, the switchable CAR-T cell \[sCAR-T\]) and SWI019 (the "switch" biologic molecule). SWI019 acts as an adapter molecule that controls the activity of the CLBR001 CAR-T cell product.

Eligibility Criteria:
Inclusion Criteria:

* Women or men age ≥18 of age at time of consent.
* Evidence of a personally signed and dated informed consent document indicating that the subject has been informed of all pertinent aspects of this study.
* Adequate hematological, liver, pulmonary, and cardiac function
* Willing to participate to participate in long term follow up study.
* Confirmed diagnosis of moderate to severe systemic lupus erythematosus with lupus nephritis, systemic lupus erythematosus with extrarenal lupus, systemic sclerosis, and idiopathic inflammatory myositis.
* Failed at least two immunosuppressive treatments

Exclusion Criteria:

* Inability to tolerate washout of prior therapy.
* Not willing/understanding the requirements of the clinical study
* Dependent on hemodialysis for a period of greater or equal to 3 months.
* Known hypersensitivity to prednisone or to both tocilizumab siltuximab.
* Have received plasmapheresis within 14 days prior to informed consent.
* Active bacterial, viral and/or fungal infection.
* Prior autologous/allogeneic stem cell transplant or solid organ transplant.
* Prior lentiviral or retroviral based therapy including CAR-T cell therapy.
* History or concurrent malignancy with active treatment in the past 5 years
* HIV-1 and HIV-2 antibody positive subjects.
* History of central nervous system diseases (such as seizure, psychosis, organic brain syndrome or cerebrovascular accident).
Hydrophilic Acrylic Intraocular Lens

The purpose of this study is to evaluate the safety and efficacy of Hydrophilic Acrylic Intraocular Lens after cataract surgery


Eligibility Criteria:
Inclusion Criteria:

* The patient is in good general and ocular health, having a vision-reducing cataract in the intended operative eye
* The patient is willing and able to complete all required postoperative visits.
* The patient is willing to sign a statement of informed consent.

Preoperative Exclusion Criteria:

* The patient is under the age of 18
* The patient has had prior intraocular surgery in the operative eye.
* The patient has systemic diseases with ocular manifestations (e.g. diabetes, complications of immune deficiency syndrome), which may contribute to postoperative confounding of data interpretation.
* The patient's worst seeing eye is 20/70 or worse.
* The patient has multiple surgical procedures at the time of implant.
* The patient has chronic use of steroids, immunosuppressive and/or antineoplastic agents.
* The patient has acute infection, inflammation of the eye.
* Iris atrophy
* Proliferative diabetic retinopathy.
* Chronic, medically uncontrolled glaucoma
* Chronic uveitis, iritis, iridocyclitis or rubeosis of the lids
* Rubella, traumatic or congenital/developmental cataract.
* Severe retinal pathology (e.g. retinal tear, detachment, etc).

Operative Patient Exclusion Criteria

* Capsular rupture
* Vitreous loss
* Hyphema
* Zonular disinsertion
* Surgical Complications- In the event of a complication during surgery, the surgeon should decide whether the stability of the hydrophilic acrylic lens would be compromised by the complication, e.g. in the event of zonular damage of major capsule rupture. If the lens stability would be compromised, the hydrophilic acrylic lens should not be implanted and the surgeon should make arrangements to implant an alternative lens.
Relationship Between the Development of Impaired Glucose Tolerance, the Phenotype of CFLD, and the Risk of Liver Fibrosis

This study proposes to examine the relationship between the development of impaired glucose tolerance, the phenotype of CFLD, and risk of liver fibrosis.

Pancreas insufficiency is a well-established risk factor for development of CF related diabetes (CFRD), but increased insulin resistance has also been demonstrated in this population. Cystic fibrosis liver disease (CFLD) is a well-established risk factor for the development CFRD. In addition, patients with CFLD and CFRD at high risk of development of severe CFLD and cirrhosis. Recent work has shown that male CF patients with abnormal oral glucose tolerance tests were noted to have elevations in ALT but the significance of this finding has yet to be fully explored. Specifically, an unresolved question remains on whether the elevation in ALT reflects a steatohepatitis as would be observed in a non-CF population or if the increased insulin resistance contributes to fibrosis progression in the classic biliary type cirrhosis seen in cystic fibrosis (CF).

Metabolic dysfunction with increasing insulin resistance has been shown to be a key component to the development of non-alcoholic steatosis hepatitis in a non-CF population. The presence of hepatic steatosis has been demonstrated in the CF population, but thus far not been linked to the development of significant steatohepatitis or cirrhosis. One potential explanation for this discordance between effects of hepatic steatosis in the CF and non-CF population, is in the non-CF population it requires multiple decades for hepatic steatosis to result in steatohepatitis and progression to cirrhosis, therefore the progressive fibrosis may not be seen in the CF population due to limited life expectancy. However, as the life expectancy in of patients with CF is increasing with new therapy, the longer-term consequences of hepatic steatosis maybe apparent

Alternatively, the presence of increased insulin resistance has been correlated to increase fibrosis progression in other forms of liver disease such as hepatitis C. Therefore, another potential mechanism is the insulin resistance seen in patients with CFRD results in increased fibrosis and development of cirrhosis in patients with classic CFLD. Thus, further characterizing the underlying liver disease phenotype and fibrosis risk in this population is of interest. We propose to examine the relationship between the development of impaired glucose tolerance, the phenotype of CFLD, and risk of liver fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Men and women ≥ 18 with CF and one of the following:

  * Normal OGTT
  * Elevated OGTT
  * Known CFRD

Exclusion Criteria:

* Men and women without CF
Comparison of Two Lower Limb Bypass Types : Prosthesis Versus Autologous Vein

When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed either with DACRON or PTFE prosthesis or with the autologous saphenous vein. Both technics are used but they have not been compared regarding bypass permeability and limb salvage. Thus, this study will compare the permeability rate of above knee femoro popliteal surgery whether performed with autologous vein versus prosthesis

When medical treatments fail, critical ischemia of the lower limb often leads to surgery, i.e. above knee femoro popliteal bypass. This bypass can be performed with either DACRON or PTFE prosthesis or with the autologous saphenous vein. The principle disadvantages of prosthesis are their prejudged worse permeability and the risk of infection. Too few reliable randomised, multicentric studies in this indication comparing vein bypasses versus prosthesis bypasses have been conducted to firmly confirm the first argument. Thus, the purpose of this multicentric, randomised, national study is to compare, 5 years after surgery, the permeability rate of above knee femoropopliteal bypass with vein versus prosthesis. Primary and secondary permeability, permeability predictive factors, and leg salvage rate will also be assessed. One hundred enrolled patients with II to IV level leg arteritis will randomly be assigned to one of the surgery groups : vein or prosthesis (50 each). The recruiting period will last 3 years and a half, and the follow up 5 years for each patient. The main primary outcome, bypass permeability, will be assessed through Doppler ultrasonography during five years. Secondary endpoints, mortality and morbidity, will be evaluated during the clinical follow up. Permeability predictive factors, primary and secondary permeability, leg salvage will also be recorded. If the permeability rates are equivalent between prosthesis and vein, the use of prosthesis will be preferred as this surgery is easier and faster, and as it is important that the vein remains available for distal revascularisation (where it is more efficient) and for revascularisation of coronary arteries

Eligibility Criteria:
Inclusion Criteria:

* lower limbs arteritis : II to IV arteritis level, above knee femoro popliteal bypass indication
* signed informed consent

Exclusion Criteria:

* no contra indication to the use of prosthesis
* Available saphenous vein
* no major trophic trouble
Residual Symptoms After Coronavirus Disease (COVID-19) in Lithuanian Population

The aim of the study is to describe the post-covid-19 syndrome in Lithuanian population regarding the remaining symptoms and their impact on physical functioning, work ability and needs of rehabilitation.

Participants with suspected and confirmed cases of COVID-19 infection will complete an anonymous online questionnaire for post-covid syndrome, i.e. symptoms lasting longer than 28 days after post-covid-19 syndrome. The online survey is developed to assess the health state before infection and residual symptoms lasting longer than acute COVID-19 infection, influencing the functional activity and work ability. The needs of rehabilitation will also be assessed.

Eligibility Criteria:
Inclusion Criteria:

* older than 18 years age patients;
* a history of COVID-19 infection that was and was not positive for SARS-CoV-2 diagnostic or antibody testing
* the duration of remaining symptoms is longer than 28 days
* ability to fulfil internet-based questionnaire

Exclusion Criteria:

* ongoing covid-19 infection
* other comorbidities requiring treatment or rehabilitation
TMS-EEG for Cortical Excitability

This research study is being done to look at the safety and diagnostic benefit of conducting an TMS(transcranial magnetic stimulation)-EEG measured before and after a brief experimental stimulation session using investigational devices repetitive TMS or transcranial direct current stimulation (tDCS).


Eligibility Criteria:
Inclusion Criteria - Stroke:

- Acquired brain injury such as ischemic or hemorrhagic stroke or traumatic brain injury.

Inclusion Criteria - Healthy Controls:

- No known active neurological disorder.

Exclusion Criteria - Stroke:

* Pregnancy
* Contraindication to MRI or TMS including metallic implanted objects.
* Medical instability or inability to cooperate during the study as assessed by the treating physician to participate in the study.
* Severe aphasia.
* History of epilepsy.
* History of active depression or treatment resistant depression.
* History of schizophrenia.

Exclusion Criteria - Healthy Controls:

* Pregnancy
* Contraindication to MRI or TMS including metallic implanted objects.
* History of acquired brain injury.
Expected Difficult Airway Management

In this study, the investigators will evaluate the advanced airway methods applied in the anesthesiology and reanimation clinic of the hospital to patients who met the criteria for awake intubation specified in the ASA 2022 difficult airway management guideline or who could not be intubated after induction of anesthesia in another center. The advanced airway method applied to the difficult airway patient expected in the operating room, the duration, success and complications of the method will be observed and recorded.

Patients who meet the inclusion criteria will be informed about the difficult airway and their verbal and written consent will be obtained.

When participants are taken to the room, an observer will be in the operation room. There was no emergency to the patient's primary anesthesiologist, will not be involved. Record patients' demographic data, Mallampati scores, thyromental distance, and neck circumference.

The airway method preferred by the physician, procedure duration, number of attempts, success, and complications will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Over 18 years old
* Meets the expected difficult airway criteria
* Being awakened after induction of anesthesia in another center
* At least one of the awake intubation criteria in the DAS 2022 guideline
* Elective surgeries

Exclusion Criteria:

* Emergency surgeries
* Patients intubated with anesthesia
* Noncoopere patients
Online Psychological Group Interventions

The aim is to assess the effectiveness of online group CBT for reducing symptoms of depression and anxiety among university students. The investigators will conduct a four-arm randomised control trial comparing a 10-session online group CBT intervention to three mental health apps (namely SilverCloud guided, SilverCloud unguided, and Mood Flow).

Email invitations and information about the study will be sent to random samples of students inviting those with symptoms of depression, anxiety, or stress to join the trial.

Students who express interest will be asked to complete an online consent form (providing more detailed information about the study and explaining potential risks and benefits of participation), following which they will complete a baseline assessment. Students who meet inclusion criteria will then be randomly allocated to one of four interventions. Follow-up assessments will be done at 3-, 6- and 12-months post intervention.

The baseline assessment will include measures of depression and anxiety, as well as factors that could potentially predict treatment responses (such as gender, age, substance use, self-harm, adverse childhood experiences, and physical health). Follow-up assessments will include measures of depression and anxiety, as well as substance use, self-harm, and treatment seeking.

The primary outcomes will be symptoms of depression and anxiety as measured by the GAD-7 and PHQ-9.

Eligibility Criteria:
Inclusion Criteria:

1. Aged 18 or older years.
2. Enrolled as a student at Stellenbosch University.
3. Provide Informed Consent.
4. Access to internet to join the online group.

Exclusion Criteria:

1. No internet availability.
2. Did not provide Informed Consent
A Novel Technique to Anaesthetize the Lower Jaw

This study introduces and evaluates a new technique for inferior alveolar nerve blocking.

The study addresses a novel technique to anaesthetize the inferior alveolar nerve depending on extraoral landmarks. Volunteers will receive bilateral blocks and evaluation of the success rate and positive aspiration rate will be performed.

Eligibility Criteria:
Inclusion Criteria:

* fitness for nerve block local anaesthesia physically and psychologically

Exclusion Criteria:

* any disease or condition obstacles nerve block local anaesthesia administration such as hemophilia.
Biomarkers in Tissue Samples From Patients Who Have Undergone Neck Dissection for Oral Cancer

RATIONALE: Studying samples of tumor tissue from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This research study is looking at tissue samples in predicting oral cancer in patients who have undergone neck dissection for oral cancer.

OBJECTIVES:

* To test preliminary data from node-positive oral squamous cell carcinoma (OSCC) signatures for their ability to predict lymph-positive primaries using a cohort of OSCC tumors.
* To perform lymph node prediction using sentinel lymph node-biopsied primaries.
* To validate the preliminary data node-positive OSCC signature and test its ability to predict nodal status.

OUTLINE: Patient tissue samples are screened using polymerase chain reaction (PCR) for human papilloma virus-specific primers. Samples are analyzed to identify a nodal-metastasis signature for oral squamous cell carcinoma. Samples also undergo microarray analysis to quantify expression levels for targeted genes. Initial data analysis is performed using Affymetrix® Microarray Suite 5.0 to quantify expression levels for targeted genes.

Eligibility Criteria:
* Have a primary tumor specimen banked by the American College of Surgeons Oncology Group (ACOSOG) as part of clinical trial ACOSOG-Z0360

  \* All tumor specimens are squamous cell carcinomas of the tongue, floor of the mouth, or gingiva
* All patients have undergone neck dissections \* Pathologically confirmed nodal stage (negative or positive)
Standardization Research of TCM Syndrome Differentiation and Treatment on Advanced Breast Cancer

The purpose of this clinical research study is to learn if the clinical effects of combined Chinese herbal medicine with endocrine therapy is better than endocrine therapy alone in improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

OBJECTIVES:

* Evaluate the effect of the Chinese herbal medicine on relieving the bone pain for patients with breast cancer bone metastasis.
* Evaluate the effect of the Chinese herbal medicine on improving the quality of life and shrinking and slowing the growth of the cancer in women with breast cancer bone metastasis.

OUTLINE: This is a randomized,multicentric, placebo-controlled, double-blind study. Patients are dynamic randomized to one of two treatment arms.

* Arm I:Patients receive traditional Chinese medicine(trial drugs) and endocrine therapy for 3 months.
* Arm II:Patients receive placebo and endocrine therapy for 3 months. All patients will be followed up for another 3 months with the trial drugs and endocrine therapy.

According to the sample size estimate:There are 296 patients (148 per treatment arm)will be collected in this trial.

Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed breast cancer and hormone receptor positive.
* Bone metastasis and have a measurable foci.
* TCM syndrome type is deficiency of both vital energy and Yin ;maladjustment of ChongRen with deficiency Yang syndrome.
* The Karnofsky score ≥60.
* VAS score ≥3.
* Expected survival at least 6 months or greater.
* Age between 20 to 70(include 20 and 70).
* The function of cardiovascular,hepar,renal and hematopoieses is relatively normal.

Exclusion Criteria:

* Women during the pregnancy or breast feeding.
* With a cardiovascular,hepar,renal,hematopoieses or other serious complications.
* Be allergic to the trial drugs.
* Participating in other trials.
Elastography and FNAC in Thyroid Nodule

Evaluate the accuracy of USE in comparison with FNAC in characterization of solitary thyroid nodule and assessment the risk of malignancy

Thyroid nodules occur commonly in the general population, mostly as incidental findings, with a prevalence of 19-68% at ultrasound (US) evaluation . However, although US is an established and very sensitive method for detecting thyroid nodule , it has a relatively low diagnostic performance when it comes to differentiating between benign and malignant nodules.

Therefore, when a patient presents with normal thyroid-stimulating hormone levels but US shows suspicious signs , a fine-needle aspiration biopsy (FNAB) is advised, fine-needle aspiration (FNA) is not a conclusive diagnostic method in all cases, considering its specificity, which ranges from 60 to 98%, and its variable sensitivity, which ranges from 54 to 90%, as well as the frequent eventual clinical need to repeat the test.

However, in consideration of the financial burden on health services, and to avoid unnecessary anxiety for patients, it is unrealistic to biopsy every thyroid nodule to obtain histological diagnosis.

In recent years, several studies have proposed the potential use of (US-elastography)to increase the accuracy of baseline US. Moreover, ultrasound elastography (USE) is emerging as a promising additional tool to discern malignant thyroid nodules, allowing increased diagnostic accuracy, especially in comparison with TIRADS (Thyroid Imaging Reporting and Data Systems). A firm or hard nodule consistency at palpation is associated with a high risk of malignancy. Due to its ability to assess stiffness as an indicator of malignancy, USE has recently become an additional tool for thyroid nodule differentiation, in combination with conventional US and FNA. In particular, strain ratio elastography (SRE) has shown high sensitivity and specificity, leading the EFSUMB (European Federation of Societies for Ultrasound in Medicine and Biology) to recommend that it should be part of the work-up of thyroid nodule characterization.

Eligibility Criteria:
Inclusion Criteria:

* all patients referred to radiology department presented clinically with solitary thyroid nodule .

Exclusion Criteria:

* patients previously underwent thyroid surgery
* patients with severe uncorrectable bleeding diathesis.
* Patients refused to sign consent.
A Study of Low and Standard-dose Ticagrelor After Intervention for ACS Patients

This study is to evaluate the safety and efficacy of 60mg ticagrelor plus 100mg Aspirin to prevent major adverse cardiovascular and cerebrovascular events in one years after drug-eluting stents implantation for Chinese ACS patients compared with 90mg ticagrelor plus 100mg Aspirin


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be at least 18 years of age
2. Patients should have undergone successful percutaneous coronary intervention with drug-eluting stent for acute coronary syndrome
3. Subject understand the study requirements and the treatment procedures and provided informed consent before the procedure

Exclusion Criteria:

1. Female of childbearing potential, unless a recent pregnancy test is negative, who possibly plan to become pregnant any time after enrollment into this study
2. Active bleeding
3. Known hypersensitivity or contraindication to study medications
4. Non-cardiac co-morbid conditions are present with life expectancy \<2 year or that may result in protocol non-compliance (per site investigator's medical judgment).
5. Subjects with Cerebral hemorrhage history
6. Subjects with stroke history in half a year
7. subjects with malignant tumor
8. subjects with whom oral anticoagulants are needed