cyrilzakka/clinical-trials huggingface dataset:
Exploring the Possibility to Use Glycosyltransferase as a Prognosis Marker of Neuroblastoma

Well-regulated glycosylation is essential for the normal development of the nervous system. Altered expression of glycosyltransferases with resulting dysregulated glycosylation of neuroblastic cells might lead to the development of NB. The β1,4-N-acetylgalactosaminyltransferase III (B4GALNT3) exhibits GalNAc transferase activity to form the GalNAcβ1,4GlcNAc (LacdiNAc or LDN) structure. The Drosophila B4GALNTA, homolog of human B4GALNT3, has been suggested to regulate the neuronal development. By immunohistochemical studies, we demonstrated that the expression of B4GALNT3 correlated well with histological grade of differentiation in NB tumor samples. Since well differentiated tumors usually carry a better prognosis, we thus speculate that expression of B4GALNT3 in tumor tissues can a favorable prognostic factor of NB.

To explore the role of B4GALNT3 in the prognosis of NB, we propose the following project with two specific aims:

Aim Ⅰ: Establishing the significance of B4GALNT3 in the prognosis of NB: We plan to collect 90 NB tumor samples, and evaluate the RNA and protein expression levels by Q-PCR, Western blot, and immunohistochemistry in the tumor samples. The results will be compared with the other clinicopathological and biological factors of NB. Also the expression levels of B4GALNT3 in tumor tissues will be correlated to the patients' outcome to clarify whether B4GALNT3 could be a prognosis marker of NB.

Aim II: Clarifying the effects of B4GALNT3 on NB cell behavior in vitro and in vivo. For further strengthening the prognostic role of B4GALNT3 in NB, NB cell phenotype and behavior changes after overexpression or knock-down of B4GALNT3 are evaluated by in vitro assays as well as by a nude mice xenograft model.

In summary, if our project can establish the role of B4GALNT3 expression in NB, we may further subclassify the NB patients, and give the NB patients more appropriate therapies to improve patients' outcome. Furthermore, B4GALNT3 could potentially serves as a therapeutic target in the future.


Eligibility Criteria:
Inclusion Criteria:

* Neuroblastoma patients with complete follow-up and sufficient samples for study

Exclusion Criteria:

* Neuroblastoma patients without complete follow-up or sufficient samples for study
CAR-T Cells Targeting Autoimmune Diseases

The purpose of this study is to assess the feasibility, safety and efficacy of CAR-T cell therapy in patients with autoimmune disease. Another goal of the study is to learn more about the safety and function of the CAR-T cells and their persistency in autoimmune disease patients.

Autoimmune disease refers to the disease in which the immune system reacts to the host's own body and causes damage to tissues and organs. At present, the pathogenesis of various autoimmune diseases is still not well understood, but an imbalanced immune tolerance plays a key role in this process.

An ideal therapy to autoimmune disease should eradicate pathogenic autoimmune cells but retain the protective immunity. The chimeric antigen receptor-modified T (CAR-T) cell technology has proven to be highly effective in targeting B cell malignancies, and the treatment-induced B cell and antibody deficiencies have implications for treating autoantibody-related autoimmune diseases. Studies have shown that CAR-T cells targeting B cell surface molecules can kill autoreactive B lymphocytes in pemphigus vulgaris (PV) and systemic lupus erythematosus (SLE) patients. Thus, CAR-T cell technology targeting B cells has potential in treating autoimmune diseases including PV, SLE, autoimmune hemolytic anemia, Sjogren's syndrome etc..

CD19-specific CAR is based on activation of intracellular signalijng domains of T cells by the extracellular single chain variable fragment (scFv) antibody against CD19. The activated CAR-T cells can target and kill B cells. The investigation plans to use genetically modified T cells to express a 4th generation lentiviral anti-CD19 CAR with an inducible caspase 9 self-withdrawal gene (4SCAR) to increase the safety of this specific approach. Besides targeting CD19, specific CARs targeting other B cell surface molecules including BCMA, CD138, and BAFF-R will also be included in the treatment regimen. Based on accumulated experiences, the 4SCAR T cells have shown high safety profile without serious cytokine release syndrome (CRS) or neural toxicities in patients. Through this trial, the safety and long term efficacy of the B cell-specific 4SCAR T cell therapy will be evaluated, providing clinical evidence supporting the application of 4SCAR-T cell technology in the treatment of autoimmune diseases.

Eligibility Criteria:
Inclusion Criteria:

1. age older than 18 years.
2. expression of B cell surface molecules.
3. the KPS score over 80 points, and survival time is more than 3 months.
4. greater than Hgb 80 g/L.
5. no contraindications to blood cell collection.

Exclusion Criteria:

1. accompanied with other active diseases and difficult to assess treatment response.
2. bacterial, fungal, or viral infection, unable to control.
3. living with HIV.
4. active HBV or HCV infection.
5. pregnant and nursing mothers.
6. under systemic steroid treatment within a week of the treatment.
7. prior failed CAR-T treatment.
Spironolactone for Paroxysmal Atrial Fibrillation

To determine whether or not spironolactone can prevent or delay the occurrence of atrial fibrillation.

To determine whether or not adding spironolactone can prevent or delay the occurrence of paroxysmal atrial fibrillation in patients who have received propafenone treatment.

Eligibility Criteria:
Inclusion criteria:

1. 18 to 80 Y/O,
2. Paroxysmal AF.

Exclusion criteria:

1. GPT\>100 IU/L or tota bilirubin \>2 mg/dl;
2. Creatinine \> 2 mg/dl;
3. Serum potassium \>= 5 mM;
4. Serum sodium \<=130 mM;
5. Uric acid \> 10 mg/dl。
An Observational Study of the Functional Capacity of Heart Failure

This is an observational study of the functional capacity of patients with Heart failure with Reduced Ejection Fraction (HFrEF) who are admitted to the hospital for routine medical treatment.

This observational study will evaluate the functional capacity (ability to walk and distance walked) of patients with Heart failure with Reduced Ejection Fraction (HFrEF) in approximately 50-70 patients who present with Acute Heart Failure to approximately 5-6 hospital sites in the USA. All enrolled patients will be evaluated for their baseline functional capacity. Patients will receive standard Acute Heart Failure therapy and will be serially assessed for change in their functional capacity.

Eligibility Criteria:
Inclusion Criteria:

* Have a left ventricular ejection fraction (LVEF) ≤40%, as assessed by any method, e.g., echocardiography, a multigated acquisition (MUGA) scan or magnetic resonance imaging (MRI);
* Present with signs and symptoms considered to be primarily due to AHF and be admitted to the hospital for AHF;
* Confirmation verbally that the patient was ambulatory, i.e., able to walk \>30m, prior to developing symptoms of AHF leading to the current admission;
* Be capable of understanding the nature of the trial; be willing and able to comply with the inpatient and outpatient study protocol requirements for the duration of the study; and be willing to participate, as documented by written informed consent.

Exclusion Criteria:

* Have a systolic blood pressure \<90mmHg or \>170mmHg at baseline;
* Have an anticipated need for an invasive procedure within 3 days of study enrollment, e.g., due to hemodynamic or cardiac rhythm instability, or acute coronary syndrome, requiring procedures including, but not limited to, cardiac catheterization, placement of a defibrillator/pacemaker, or placement of a pulmonary artery catheter;
* Have a primary HF etiology attributable to either restrictive/obstructive cardiomyopathy, idiopathic hypertrophic cardiomyopathy (as defined by any wall thickness \> 1.8cm) that is obstructive, or uncorrected severe valvular disease (except mitral regurgitation);
* Have any other comorbidities that limit ambulation more than the patient's heart failure, e.g., symptomatic peripheral arterial disease, COPD, arthritis or other condition, as confirmed verbally with the patient;
* Have severe renal insufficiency (defined as a GFR \<30mL/min/1.73m2 according to the MDRD equation);
* Have an anticipated survival of less than 90 days, for any reason;
* Have received an investigational agent (drug, device or biologic product) within 30 days (or, if longer, 5 half-lives for a drug or biologic agent) prior to study entry, or be planning to receive an investigational agent at any time throughout the full duration of the study until at least Study Day 35;
* Have any other clinically significant laboratory abnormality, medical condition or social circumstance that, in the investigator's opinion, makes it inappropriate for the patient to participate in this clinical trial.
A Trial of SHR-A2102 With Antitumor Therapy in Advanced Urothelial Carcinoma

The study is being conducted to evaluate the safety, tolerability and efficacy of SHR-A2102 for injection with Antitumor Therapy in Advanced Urothelial Carcinoma. To explore the reasonable dosage of SHR-A2102 for Advanced Urothelial Carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Competent to comprehend, sign, and date an informed consent form.
2. Male or female subjects must be age 18 or older.
3. Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1.
4. Subjects must have histologically documented, unresectable locally advanced or
5. Histologically confirmed locally advanced or metastatic urothelial cancer.Phase Ib, subjects must have failed, be intolerant or refused the standard treatment; Phase II, subjects must not have received systemic antitumor therapy for locally advanced unresectable or metastatic urothelial carcinoma.
6. An archival tumor tissue sample or a fresh tissue sample should be provided.
7. Subjects must have measurable disease according to RECIST (version 1.1).

Exclusion Criteria:

1. Subjects with not adequately treated, or uncontrollable , or active CNS metastases.
2. Subjects who have previously received TOPO1-based ADCs.
3. Subjects who have received anti-cancer treatment within 4 weeks prior the first dose of study treatment.
4. Subjects who have received radiotherapy within 14 days , or chest radiotherapy \> 30Gy within 6 months prior to the first dose of study drug.
5. Subjects with ongoing clinically significant toxicity associated with prior treatment that has not resolved to ≤ Grade 1.
6. Subjects who have received systemic immunosuppressant treatment within 14 days prior the first dose of study treatment.
7. Subjects who have known or suspected interstitial pneumonitis.
8. Phase Ib: Subjects who have had≥ Grade 3 irAEs during the previous treatment with ICIs.
9. Subjects who have any active, known or suspected autoimmune diseases.
10. Subjects who have moderate or severe ascites with clinical symptoms, or uncontrolled or moderate or above pleural effusion, or pericardial effusion.
11. Subjects who have uncontrolled cardiac diseases or cardiac clinical symptoms.
Primary Progesterone Therapy for Operable Breast Cancer

The purpose of this study is to test the effect of primary progesterone on overall and disease free survival in women with operable breast cancer. The study addresses two issues related to breast cancer surgery:

* Circulating progesterone at the time of surgery might counteract the detrimental effect of estrogen on survival of women with operable breast cancer.
* Events at the time of surgery may have an impact on the natural history of breast cancer

This protocol addresses the issue of pre-operative hormone manipulation in women with operable breast cancer. The study has been designed after careful review of literature to assess the effect of unopposed oestrogen at the time of surgery and collect evidence that events at the time of surgery may have impact on the long-term survival of breast cancer patients. The meta-analysis of 37 studies on timing of surgery during the menstrual cycle showed a 15% + 3 improvement in survival for women who had undergone surgery during the luteal phase of their menstrual cycle. Three of the 37 studies where progesterone levels were estimated at the time of surgery showed 52% + 26 improvement in survival when circulating progesterone were \> 1.5 ng/ml. The study aims to produce luteal milieu by injecting Hydroxy- progesterone 500 mg IM at the time of surgery. The timing of administration of progesterone in the neo-adjuvant setting is decided after collating data from large data-bases and randomised trials of screening suggesting that events at the time of surgery may alter the behavior of micro-metastases.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral operable palpable breast cancer

Exclusion Criteria:

* Previous history of excision biopsy of the primary tumour
* History of other epithelial/mesenchymal malignant tumours except basal cell carcinoma/squamous cell carcinoma (BCC/SCC) of skin
The Effect of Patient's Position After Intra-tympanic Injection on the Amount of Fluid in the Middle Ear

During the regular protocol of Intra-tympanic injections of Dexamethasone to the middle ear due to Sudden Sensorineural Hearing Loss, the patients will be sitted once after the injection instead of lying down. They will be then asked to rate their taste as a reference to the amount of fluid leaking to the throat through the eustachian tube.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with Sudden Sensorineural Hearing Loss, treated using intra-tympanic injection of steroids to the middle ear

Exclusion Criteria:

* Patients with abnormal sense of taste
* Middle or inner ear anomaly
* Eustachian tube dysfunction
Extending HIV Care Beyond the Rural Health Center

The objective of this application is to develop and assess a system which uses non-clinician extenders to provide selected aspects of HIV care in rural western Kenya. The plan is to train persons living with HIV/AIDS (PLWAs) to undertake this role as Community Care Coordinators. Our central hypothesis, is that PLWAs can be effective members of the health care team and that their involvement in community-based HIV care will facilitate patient access to services and improve outcomes. As such our two specific aims are: 1) To develop a sustainable system to extend HIV care into the community and to train the individuals necessary to support such a system (Community Care Coordinators). 2) To determine the impact of Community Care Coordinators on patient adherence (to drugs and to clinic visits), clinical outcomes (i.e. viral load responses \[an individuals level of circulating HIV virus\], inter-current opportunistic infections, hospitalization, drop out from the program, change to second line therapy and mortality) and patient perception of stigma. This study will provide invaluable data on the use of non-clinician care extenders for providing HIV care in resource poor settings. As such, knowledge gained from this study will assist in developing a model for non-clinician centered HIV care systems elsewhere in sub-Saharan Africa.


Eligibility Criteria:
Inclusion Criteria:

1. HIV infected
2. \>18 years old
3. household members are aware of the patient's HIV infection
4. clinically stable on ARVs and no significant adherence issues for 3 months, 5) live in Kosirai Division

6) willing to consent to participate.

Exclusion Criteria:

1. active opportunistic infection
2. pregnant
3. hospitalized in the previous 3 months
4. unable to understand the informed consent process due to mental or physical incapacity.
The Novel Unloading Device "HEPHAISTOS" and Its Effects Upon Bone, Muscle and Vasculature

The present study aimed to investigate the importance of gravitational induced forces that appear during normal ambulation for the health of muscles, bones and blood vessels. The main hypothesis of the present study is that gravitational loading alone, without muscle contractions, is insufficient to maintain bone strength.

The 56day unloading intervention with HEPHAISTOS had the following key objectives:

1. Primary objective: Assessment and evaluation of bone adaptation.
2. Secondary objective: Assessment and evaluation of functional and structural muscular adaptations.
3. Third objective: Assessment and evaluation of functional and structural vascular adaptations.
4. Fourth objective: Assessment and evaluation if the present findings deviate from findings observed in established unloading models.

Eligibility Criteria:
Inclusion Criteria:

* male
* age: 20-40 years
* BMI: 20-30
* passing the psychological and medical check up.
* signed consent to participate in the study
* faultless certificate of good conduct

Exclusion Criteria:

* smoking
* professional athletes
* diabetes
* muscle or joint disease
* trabecular bone density in the distal tibia epiphysis \< 160mg/cm3
* increase risk of thrombosis
* bone fractures 12 months prior to the study
* metal implants, any material of osteosynthesis
* participation in another clinical intervention study 2 months prior to the study
* bleeding disorder
* anesthetic intolerance
* vascular disease
* epilepsy
* claustrophobia
* herniated disk
* pacemaker
* alcohol or drug abuse
* anti-inflammatory drug intake during the study
* hyperlipidemia
* kidney disease
* hyperhomocysteinaemia
* vitamin d deficit
* chronical back pain
* detained
Exploratory Study of Intermittent Hypoxia Treatment in Chronic Cerebral Hypoperfusion

This study aims to investigate the safety and efficacy of intermittent hypoxia treatment in patients with chronic cerebral hypoperfusion.

Chronic cerebral hypoperfusion is a common and frequently occurring disease in middle-aged and senior people, and an important cause of multiple diseases such as acute ischemic stroke and vascular dementia. However, current treatments for chronic cerebral hypoperfusion are limited and nonspecific. Intermittent hypoxia refers to periodic intervention with alternating normoxia and hypoxia. Studies have shown that short-term (5-10min), low frequency (3-15 times), and mild to moderate hypoxia (9-16%) usually have protective effects and can improve cerebral blood perfusion. Therefore, this study is an exploratory study combining intermittent hypoxia treatment with chronic cerebral hypoperfusion, aiming to preliminarily explore the safety and potential effectiveness of intermittent hypoxia treatment in the using of chronic cerebral hypoperfusion.

Eligibility Criteria:
Inclusion Criteria:

* Subjects aged 45-70 years, BMI 18.5-24kg/m2, both sexes.
* Subjects with risk factors of cerebrovascular disease, such as hypertension, diabetes, dyslipidemia, and so on, and the risk factors are well controlled.
* Cerebral/carotid ultrasound showed mild stenosis of unilateral internal carotid artery (ICA) or middle cerebral artery (MCA) (\<50%) without stenosis of other major feeding arteries.
* Subjects with the manifestations of chronic cerebral hypoperfusion, such as dizziness, head pain, memory loss, slow reaction, inattention, emotional instability, decreased ability to work, sleep disorders and mood disorders, the course of more than 3 months.
* Subjects or their legally authorized representative can provide informed consent.

Exclusion Criteria:

* Stroke onset in the past 3 months, other severe neurological diseases, such as epilepsy, intracranial infectious diseases or demyelination.
* Uncontrolled hypertension (systolic blood pressure ≥200mmHg) with antihypertensive drugs before enrollment, other cardiovascular diseases.
* History of pulmonary, hepatic, dermatologic, or hematologic diseases.
* History of substance abuse.
* Pregnancy, hypertension, diabetes mellitus, obesity, sleep apnea and neurological disorders.
5-HIAA in Urine Versus 5-HIAA in Plasma Patients With a Serotonin Producing Neuroendocrine Tumor'

The objective of this observational laboratory study is to measure the correlation between 5-hydroxyindolacetic acid (5-HIAA) in platelet rich plasma and 5-HIAA in 24-hours urine collection in adult patients with a serotonin-producing neuro-endocrine tumor. Plasma and urine of included patients are collected and 5-HIAA values are measured with LCMS-MS and analysed.

In midgut NETs serotonin production is most prominent. Patients with NETs producing excessive serotonin can develop carcinoid syndrome. Serotonin is a product of the 'tryptophan pathway'. Serotonin is metabolized in 5-hydroxyindolacetic acid (5-HIAA) and then excreted with urine. 5-HIAA in 24-hour urine collection is one of the parameters used for follow up in patients with a serotonin-producing neuroendocrine tumor. This measurement has some disadvantages; it could be stressful, the collection is not always precisely, furthermore the collection could be problematic, for example in patients with diarrhea.

Since October 2013 it is possible, because of a better measurement sensitivity, to measure reliably 5-HIAA in platelet rich plasma (PRP) by isotope-dilution massa-spectrometer (LCMS-MS). Recent publications show that 5-HIAA measured in PRP could have an additive value in diagnosis and follow up of patients with serotonin-producing NET.

Objective:

The primary objective is to measure the correlation between 5-HIAA in PRP and 5-HIAA in 24-hours urine collection in adult patients with a serotonin-producing neuro-endocrine tumor.

Secondary objective is to determine if increase or decrease of 5-HIAA in plasma is associated with disease progression.

Study design:

This is an observational laboratory study. Plasma and urine of included patients and collected in standard health care, are selected and the 5-HIAA's are measured with LCMS-MS. Also age, sex, diagnosis and clinical course of the patients will be collected from the medical record.

Study population:

In this study the investigators will use blood and urine of 60 patients with serotonin-producing neuro-endocrine tumors.

Main study parameters/endpoints:

The main endpoint of this study is the correlation between 5-HIAA in PRP and 5-HIAA in 24-hour urine collection. Secondary endpoint is the correlation between 5-HIAA in PRP and course of the disease, determined by CT-scan (if applicable).

Eligibility Criteria:
Inclusion Criteria:

In order to be eligible to participate in this study, a subject must meet all of the following criteria:

* Serotonin in platelets \> 5.4 nmol / 10\^9 and 5-HIAA in 24-hours urine \>3.8 mmol/mol creatinine
* Adult NET patients (aged ≥ 18 years of age)
* Blood and urine collection of the patient are collected within four days Patients are allowed to be included more than once.

Exclusion Criteria:

* A potential subject who meets any of the following criteria will be excluded from participation in this study:
Perioperative Management of Patients With Coronary Stents Undergoing Noncardiac Surgery

The purpose of this study is to evaluate and monitor perioperative management of patients with coronary stents undergoing noncardiac surgery.

Objectives:

* To describe the incidence and severity of adverse cardiovascular events in patients with coronary stents undergoing noncardiac surgery with admission.
* To assess the following-up of the guidelines about the perioperative management of antiplatelet therapy in these patients.
* To assess the relationship between the incidence of cardiac or neurovascular events, as well as bleeding complications with the perioperative management of antiplatelet therapy.
* Number of Participants with Adverse Events as a Measure of Safety

(Not desired)

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years old, with coronary stents
* American Society of Anaesthesia physical status II-V
* noncardiac surgery wiht admission
* informed consent

Exclusion Criteria:

* \< 18 years old
* American Society of Anaesthesia physical status I
* ambulatory surgery
* pregnancy
* obstetric anaesthesia
* endoscopic procedures
* cardiac surgery
* not informed consent