cyrilzakka/clinical-trials huggingface dataset:
Trial of Anti-PSMA Designer T Cells in Advanced Prostate Cancer After Non-Myeloablative Conditioning

This study tests the safety and tolerability of autologous anti-PSMA gene-modified T cells (designer T cells) in hormone refractory prostate cancer.

The study creates autologous gene-modified T cells against prostate specific membrane antigen (PSMA, unrelated to PSA) (designer T cells) by ex vivo modification of patient T cells. T cells are collected by leukopheresis, transported to the RWMC cGMP Cell Manipulation Core and transduced with retrovirus containing a chimeric antigen receptor (CAR) that is expressed on the modified cells. This CAR links specificity of an antibody against PSMA with signaling domains of the T cell and redirects the recognition of the T cells to engage and kill prostate cancer cells anywhere in the body. These are administered at a dose of 10\^10 with randomization to either low or moderate Interleukin 2 given by CI (continuous infusion) for one month following the T cell infusion. Subsequent subjects will receive 10\^11 cells with Interleukin 2 at either low or moderate dose, in a non randomized manner, depending upon the outcome of the prior cohort. Prior to T cell infusion, all subjects will receive non-myeloablative (NMA) conditioning. This conditioning creates a "space" in the blood and marrow for engraftment of the infused cells to maintain of high level of anti-tumor effector T cells in the body. Each patient is treated with a single dose of T cells, without repeat dosing. Patients are followed for toxicity and response and pharmacokinetics-pharmacodynamics of the infused T cells. Patients are on-study for one-month after their T cell dose.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of prostate cancer
2. Elevated PSA
3. Life expectancy \> 4 months
4. Performance status 0-1
5. ANC 1.0
6. Platelets \> 100,000
7. Hemoglobin \> 8.0
8. Creatinine \< 1.5mg/dl
9. Direct Bilirubin \< 1.5 mg/dl
10. No evidence of CHF, CAD, cardiac arrhythmias, A-fib, A flutter, myocardial infarction.
11. No serious, symptomatic obstructive or emphysematous lung disease
12. No asthma requiring IV medication during last 12 months, no serious lung disease associated with dyspnea at normal activity levels, or at rest due to any cause, including cancer metastasis and pleural effusion
13. Patients must have a biopsy able tumor, and be willing to undergo biopsy (Group 3 only)
14. Patient is at least 18 years of age.

Exclusion Criteria:

1. Serious or unstable renal, hepatic, pulmonary, cardiovascular, endocrine, rheumatologic or allergic disease based on history, labs or physical exam
2. Active clinical disease caused by CMV, Hepatitis B, or C, HIV, TB
3. Cytotoxic and/or radiation therapy during last 4 weeks prior to entry
4. Any concurrent malignancies
5. Patient requires systemic steroids
6. Patient has participated in prior investigational therapy
7. Patient has prior exposure to mouse antibody
8. Patient has had irradiation to whole pelvis or \>25% marrow
Beijing Indoor Air Purifier Intervention Study

This study aimed to assess the impact of air filtration on indoor air quality and cardio-pulmonary health in residents living in high outdoor pollution settings in Beijing.


Eligibility Criteria:
Inclusion Criteria:

* Global Initiative for Chronic Obstructive Lung Disease criteria (mild to moderate, GOLD stage I\~II;
* severe to very severe, GOLD stage III\~IV) quit smoking for at least 1 year;
* a ratio of pre-bronchodilator forced expiratory volume in one second (FEV1) to forced vital capacity (FVC) equal to or less than 0.70 and an increase of FEV1 with the use of 400μg of albuterol of less than 12% of the pre-bronchodilator one;
* no history of asthma or any other active lung disease.
* Subjects were free from exacerbations for at least 6 weeks.

Exclusion Criteria:

* Patients with heart pacemaker,
* heart failure with bundle-branch block,
* recent myocardial infarction (in the last 12 weeks) and
* anticoagulant therapy
Machado-Joseph Disease in Israel

Machado-Joseph disease (MJD) or spinocerebellar ataxia type 3 (SCA-3) is the most common dominant ataxia. The genetic cause of this late-onset degenerative disorder is the expansion of a (CAG)n tract located in the exonic region of the ATXN3 gene. In 1994 the first case of MJD among the Yemenite Jewish subpopulation living in Israel was published. The puropse of this study is to describe the clinical phenotype and genotype of the Yemenite Jewish subpopulation with MJD living in Israel


Eligibility Criteria:
Inclusion Criteria:

* Spinocerebellar Ataxia 3 Yemenite Jews patients

Exclusion Criteria:

* All others
PD-1 Combined With Intensity Modulated Radiation Therapy in the Treatment of Intermediate-risk Nasopharyngeal Carcinoma

To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).

To evaluate the safety and efficacy of PD-1 immune checkpoint inhibitor combined with intensity modulated radiation therapy in the treatment of intermediate-risk nasopharyngeal carcinoma (T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml).The primary end point is safety, the secondary end points are short-term efficacy,overall survival (OS), progression-free survival (PFS),Distant metastasis-free survival(DMFS),adverse effects ,quality of life and immune status assessment.

Eligibility Criteria:
Inclusion Criteria:

* Newly diagnosed patients who have not received radiotherapy or chemotherapy
* Pathologically diagnosed as non-keratinizing nasopharyngeal carcinoma (differentiated or undifferentiated, WHO classification type II or type III).
* T2-3N0 or T1-2N1 stage and EBV-DNA≤4000 copy/ml (AJCC 8th version) and EBV-DNA≤4000copies/ml
* Male or non-pregnant female
* Age between 18 and 65
* Eastern Cooperative Oncology Group（ECOG）score of 0-1.
* Hemoglobin (HGB) ≥90 g/L, white blood cell (WBC) ≥4×109/L, platelet (PLT) ≥100×109/L.
* Liver function: Alanine aminotransferase (ALT), aspartate aminotransferase (AST) \<2.0 times the upper limit of normal (ULN); total bilirubin \<2.0×ULN.
* Renal function: creatinine clearance rate ≥60ml/min or serum creatinine \<1.5×ULN.
* The patient has signed the informed consent

Exclusion Criteria:

* The pathology is keratinizing squamous cell carcinoma (WHO classification is type I).
* Patients with recurrence and distant metastasis.
* Patients who have undergone radiotherapy or chemotherapy.
* Active hepatitis B (HBV-DNA≥500).
* Patients with autoimmune diseases.
* Patients with HIV infection.
* At the same time suffering from other uncontrolled serious diseases.
* Persons with abnormal functions of the heart, brain, lungs and other important organs.
* Age\> 65 years.
* pregnancy or breast feeding.
* Persons with personality or mental illness, without or with limited capacity for civil conduct
Feasibility of Identifying Brain Mechanisms of Qigong and Behavioral Outcomes After Qigong Practice in People With Chronic Low Back Pain

The long-term objective of this investigation is to identify how Qigong affects brain function in brain areas relevant to patients with chronic low back pain (cLBP), thereby setting a foundation from which to perform further clinical research.

The central hypothesis of this investigation is that, in adults with cLBP, practicing Qigong compared to exercise will result in reduced pain and improved body awareness and proprioception (primary behavioral endpoints), disability, balance, core muscle strength, and other CLBP symptoms will be secondary behavioral endpoints.To test this hypothesis, the investigators will assess (1) participant recruitment and retention ; (2) adherence to interventions, engagement/satisfaction with the program; and (3) changes in body awareness-related brain activation and connectivity pre-post intervention (Qigong vs exercise) related to primary endpoints of pain perception, body awareness and objective measures of lower limb proprioception.

Eligibility Criteria:
Inclusion Criteria:

- Adults with chronic low back pain

Exclusion Criteria:

* Those with cognitive problems
* Those unable to speak or understand instructions
* Those who have nerve problems, fractures, or infections
* Those who do not speak English
* Those with severe deficit in motor imagery or in vision (both are used in MRI tasks)
Autologous Bone Marrow Mesenchymal Stem Cells Transplantation Via Hepatic Artery in Patients With Liver Cirrhosis

The purpose of this study is to investigate the efficacy of autologous bone marrow mesenchymal stem cells (MSCs) transplantation via hepatic artery in the treatment of liver cirrhosis. Liver function was monitored by serum examination. The levels of serum alanine aminotransferase (ALT), total bilirubin (TB), prothrombin time (PT) and albumin (ALB) were examined at pre-transplantation, and 3 days to 2 years post-transplantation. Child-Pugh scores and clinical symptoms were also observed simultaneously.

Patients with liver cirrhosis were randomly separated into two groups. Autologous MSCs were infused to patients using interventional method via hepatic artery for One group. The catheter was inserted to proper hepatic artery. After the catheter placed at proper hepatic artery was confirmed by angiography, autologous bone marrow MSCs were infused slowly for 20-30 minutes. The control group accepted conserved therapy.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-70 years.
* Imaging evidences of liver cirrhosis.
* Child-Plough score of 10 or more.

Exclusion Criteria:

* Liver tumor on ultrasonography, CT or MRI examination.
* Problems in organs other than the liver(e.g.the heart or lungs).
* History of moderate to severe hepatic encephalopathy or variceal bleeding.
* Imaging evidences of vascular thromboses.
* Coma.
Investigation of the Epidemiological Factors Associated With the Development of Amyotrophic Lateral Sclerosis (ALS)

Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-

1. Differences between ethnic subgroups
2. Differences between immigrant and native-born populations
3. Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

Investigation of the epidemiological factors associated with amyotrophic lateral sclerosis (ALS) in Israel with a view to future international collaboration. Particularly addressing:-

1. Differences between ethnic subgroups
2. Differences between immigrant and native-born populations
3. Differences according to military service profile Clinical features gathered at each routine visit ,throughout the entire course of the disease, will be recorded in database format, in order to correlate with potential epidemiological factors.

The clinical features will include pattern of onset, details of full clinical exam ( including ALSFRS-R score, power, reflexes, and other signs of upper or lower-motor neuron dysfunction.

Correlations between different clinical parameters themselves will be made, as well as correlation between clinical parameters and other epidemiological factors.

Eligibility Criteria:
Inclusion Criteria:

- Suspected, possible, probable ,definite ALS

Exclusion Criteria:

-
Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation

To evaluate the safety and performance of the Tendyne™ Mitral Valve System when used as intended in a contemporary, real-world setting.

The Tendyne RESOLVE-MR study (Real World Study of the Tendyne™ Mitral Valve System to Treat Mitral Regurgitation) is a prospective, single arm, multi-center, PMCF study, which will be used to support the CE Mark requirement of monitoring safety and performance for any complications or issues arising in a post-market setting.

The objective of the Tendyne RESOLVE-MR study is to confirm the safety and performance of the Tendyne Mitral Valve System in patients with symptomatic, moderate-to-severe or severe mitral regurgitation (MR) who are considered by the local heart team as eligible for a transapical transcatheter mitral valve implantation in a real-world setting. This clinical study is intended to satisfy post-market clinical follow-up requirements of CE Mark.

Eligibility Criteria:
Inclusion Criteria:

1. Patient is indicated for the Tendyne Mitral Valve System per the Instructions for Use.
2. Patient is willing and able to comply with all follow-up requirements through five years, including study-required testing, medications, and attending all follow-up visits.
3. Patient provides written informed consent prior to any study-specific procedure.

Exclusion Criteria:

1. Patient is in another clinical study that may impact the follow-up or results of this study.
2. Patient is pregnant or nursing or plan to become pregnant during the study follow-up period.
3. Patient is under the age of 18 or age of legal consent.
4. Patient has other anatomic or comorbid conditions, or other medical, social, or psychological conditions that, in the investigator's opinion, may limit the subject's ability to participate in the clinical study or to comply with follow-up requirements.
Home Ovulation Test One Cycle at Home Study

This study will assess the usability of a Home Ovulation Test when used at home by lay-users seeking to conceive.

This study will assess the ease of use of a Home Ovulation Test when used by lay-users for one cycle in their home environment. The home ovulation test to be used in the study is a visual home ovulation test used to detect luteinising hormone (LH) in urine to identify when ovulation is imminent.

A sample size of 120 volunteers (minimum) will provide adequate information for assessing the usability of the home ovulation test. Usability of the test will be assessed through a questionnaire completed at the end of the study.

This observational study will be conducted remotely and volunteers representative of the intended user (lay-users) will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Female
* Aged 18 to 45 years
* Seeking to conceive
* Willing to give informed consent and comply with the investigational procedures

Exclusion Criteria:

* Taking medication, or has known condition which means they should not get pregnant.
* Currently pregnant or breastfeeding
* Used the test within the last six months
* Currently or previously employed by SPD, Abbott, Alere, Unipath, P\&G or affiliates
* Has an immediate\* relative currently or previously (within past 5 years) employed by Swiss Precision Diagnostics (SPD), Abbott, Alere, Unipath or P\&G, or affiliates

  \*Immediate relatives are defined as parents, children, siblings or partner/spouse
* Is a qualified or trainee healthcare professional (HCP)
* Has professional experience of using dipstick type tests or lateral flow devices
* Using any treatment which may affect the menstrual cycle (e.g. contraceptive pill)
* Using infertility medications or hormone replacement medications containing Luteinising Hormone (LH) or human Chorionic Gonadotrophin (hCG) (e.g. Pregnyl®)
* Using or undergoing any other medical treatment for fertility such as ovulation drugs, artificial insemination and assisted fertility such as In vitro fertilization (IVF) or Intracytoplasmic sperm injection (ICSI)
* Peri-or post-menopausal, e.g. experiencing symptoms: irregular menstrual periods, hot flushes, night sweats, sleep disturbances and/or moods swings
* Has been diagnosed with polycystic ovarian syndrome (PCOS)
* Has PCOS symptoms e.g. very irregular cycles, hirsutism
A Novel Approach for Alleviating the Side Effects of Chemotherapeutic Agents.

This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients.

This study will assess the effectiveness of a natural nutraceutical in treating the known side effects of chemotherapeutic agents in cancer patients. The study will be observing the standard treatment protocol for any degradation or enhancement due to the nutraceutical.

Eligibility Criteria:
Inclusion Criteria:

Active breast cancer patients taking one of the studies listed drugs within the age range.

Active lung cancer patients taking one of the studies listed drugs within the age range.

Active prostate cancer patients taking one of the studies listed drugs within the age range.

-

Exclusion Criteria:

Anyone without the three types of cancer (breast cancer, lung cancer, prostate cancer) listed in inclusion criteria.

-
A Study of Ocrelizumab in Children and Adolescents With Relapsing-Remitting Multiple Sclerosis

This 2-year study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamic (PD) effects of ocrelizumab in children and adolescents ages ≥ 10 to ≤ 18 years with relapsing-remitting multiple sclerosis (RRMS). The data from this study will serve to determine the dosing regimen of ocrelizumab to be further investigated in the subsequent Phase III study in children and adolescents.


Eligibility Criteria:
Inclusion Criteria:

* Body weight \>/= 25 kg
* Children and adolescents must have received all childhood required vaccinations
* Female participants of childbearing potential must agree to either remain completely abstinent or to use reliable means of contraception
* Diagnosis of relapsing-remitting multiple sclerosis (RRMS)
* Expanded Disability Status Scale (EDSS) at screening: 0-5.5, inclusive
* Neurologic stability for \>/= 30 days prior to screening, and between screening and baseline
* Participants naive to prior disease-modifying therapy (DMT)
* Participants who have had at least 6 contiguous months of DMT within the past 1 year must have evidence of disease activity occurring after the full 6-month course of treatment, that is, at least one relapse or \>/= 1 Gd-enhancing lesion(s) on a T1-weighted brain MRI

Exclusion Criteria:

* Known presence or suspicion of other neurologic disorders that may mimic MS, including, but not limited to, acute disseminated encephalomyelitis, neuromyelitis optica or neuromyelitis optica spectrum disorders and any neurologic, somatic, or metabolic condition that could interfere with brain function or normal cognitive or neurological development
* Patients that are aquaporin 4 positive and myelin oligodendrocyte glycoprotein (MOG) antibody positive are not eligible to participate in the study.
* In case of an ADEM-like appearance of the first MS attack, a second attack with clear MS-like features is required.
* Infection requiring hospitalization or treatment with IV anti-infective agents
* History or known presence of recurrent or chronic infection (e.g., HIV, syphilis, tuberculosis)
* Receipt of a live or live-attenuated vaccine within 6 weeks prior to treatment allocation
* History or laboratory evidence of coagulation disorders
* Peripheral venous access that precludes IV administration and venous blood sampling
* Inability to complete a magnetic resonance imaging (MRI) scan
* History of cancer, including solid tumors, hematologic malignancies, and carcinoma in situ
* History of a severe allergic or anaphylactic reaction to humanized or murine monoclonal antibody (mAbs) or known hypersensitivity to any component of ocrelizumab solution
* Previous treatment with B-cell-targeted therapies
* Percentage of CD4 \< 30%
* Absolute Neutrophil Count \< 1.5x1000/microliter
* Lymphocyte count below the lower limit of normal (LLN) for age- and sex-specific reference range
Helicobacter Pylori, Atrophic Gastritis and Intestinal Metaplasia Registry and Prospective Study

Since much is unknown about factors that lead to progression of the pre-neoplastic lesions and cancer. In addition, there is ongoing debate on the optimal surveillance intervals and techniques. To solve these important clinical questions, the establishment of a registry for a longitudinal study is planned.

Helicobacter pylori is believed to affect more than half of the world's population and is thought to affect nearly 2 million people in Hong Kong alone. It is a major cause of peptic ulcer disease and is implicated in the pathogenesis of the majority of gastric cancers. Since 1994, the World Health Organization has designated H. pylori infection as a class 1 carcinogen. Gastric cancer was the sixth commonest malignancy in Hong Kong in 2015; it was also the second commonest cause of death from cancer in Asia. It is thought that chronic inflammation of the gastric mucosa caused by H. pylori progresses to pre-neoplastic lesions, namely atrophic gastritis and intestinal metaplasia, before developing into frank dysplasia and carcinoma. Successful H. pylori eradication can lead to a rapid decrease in active inflammation, with early treatment effective in preventing the progression of disease. It is believed that atrophic gastritis may be reversible, whereas intestinal metaplasia has passed the point of no return and unlikely to have regression. National screening programmes in both Japan and Korea recommend endoscopy for all men and women over 40 years of age with several uncontrolled trials suggesting that this has led to a reduction of mortality due to gastric cancer. However, in countries with a lower incidence of gastric cancer, this population-based approach may not be cost-effective. Much is unknown about factors that lead to progression of the pre-neoplastic lesions and cancer. In addition, there is ongoing debate on the optimal surveillance intervals and techniques. To solve these important clinical questions, the establishment of a registry for a longitudinal study is planned.

Eligibility Criteria:
Inclusion Criteria:

* Adults \>= 18 years of age
* Written informed consent obtained
* Diagnosed with current or past H. pylori infection,
* Histologically proven atrophic gastritis (body and/or antrum of stomach), intestinal metaplasia (complete and incomplete), dysplasia (any grade) and/or gastric cancer (post- treatment)

Exclusion Criteria:

* Co-morbid illness that prohibit endoscopic surveillance
* Declines for study questionnaire, biobanking of specimens and/or regular review per study protocol
Determination of Pharmacokinetics of Different Curcuminoids Preparations: Pilot Study

This pilot study aims to investigate the pharmacokinetics of a novel curcuminoid preparation with suggested high bioavailability due to its solubility in water, compared to two standard hydrophobic formulations. The findings of this study will help the health care providers and community to select suitable formulation.

This pilot study is the first phase that must be followed, in the second phase, by longer clinical trials to support the findings and investigate the role of the novel preparation on health.The second phase will include an assessment of the effectiveness of several doses of curcumin preparation on health as well as an evaluation of the tolerance and possible adverse effects. The latter could not be evaluated at this stage of a single dose.

Eligibility Criteria:
Inclusion Criteria:

Male and female Apparently healthy adults

Exclusion Criteria:

Postmenopausal women Smokers Overweight Chronic diseases