cyrilzakka/clinical-trials huggingface dataset:
Study on the Antiaging Effect of Chinese Herb Drink

The purpose of the current study was to check the physiological improvement of SWT on liver and skin and also the antioxidation in healthy adults.

Background: Si-Wu-Tang (SWT) is a well-known traditional Chinese medicine (TCM) and widely used for treating various gynecological disorders. The purpose of the current study was to check the physiological improvement of SWT on liver and skin and also the antioxidation in healthy adults.

Methods: Sixty healthy voluntary subjects were recruited and assigned into two groups, who drank 125 mL of placebo (n=30) or SWT (n=30) for 6 continuous days per month during the following 6 months and vice versa with one month of washout period in between. During the initial, 3rd, 6th, 10th, and 13th months anthropometric measurements were performed as well as fasting blood samples were drawn for various biochemical assays. Abdominal ultrasonic and skin examination were performed at the initial, 6th and 13th months.

Eligibility Criteria:
Inclusion Criteria:

* healthy adults

Exclusion Criteria:

* exclusion criteria were history of smoking, alcoholism
* pregnant or lactating women,
* chronic diseases, hepatic or renal dysfunction.
Manual Lymphatic Drainage Before and After Total Knee Replacement, a Single-center Observer-blinded Randomized Controlled Trial

The aim of this observer-blinded randomized controlled trial is the evaluation of the influence of manual lymphatic drainage (MLD) on the outcome of patients receiving total knee replacement (TKA).


Eligibility Criteria:
Inclusion Criteria:

* Total Knee Arthroplasty (TKA)

Exclusion Criteria:

* Venous insufficiency
* BMI \> 38
* Vascular disease
Novel SARS-CoV-2 Point-of-care Testing

The aim of the project is to study the feasibility of implementing a novel point-of-care test (POCT) for rapid detection of SARS-CoV-2 infection. A CRISPR-based detection kit would be piloted for testing of suspected SARS-CoV-2 infection in healthcare setting, with the objectives of evaluating the performance of the new test in the detection of SARS-CoV-2, and assessing the practicability of the new test for diagnosing SARS-CoV-2 infection in healthcare settings.

A CRISPR-based lateral flow assay (LFA) detection kit would be designed and developed for testing for the presence of SARS-CoV-2. The aim of the project is to study the feasibility of implementing the novel point-of-care test (POCT) for rapid detection of SARS-CoV-2 infection in health service setting, with the following objectives: (b) Evaluation of the performance of novel POCT in comparison with conventional quantitative PCR in diagnosis SARS-CoV-2 infection and (c) Assessment of the practicability of LFA-CRISPR-based tests in the operating environments in healthcare settings.

Patients who are admitted to the isolation wards of Prince of Wales Hospital, Hong Kong would be invited to join the study. A total of 600 persons with suspected SARS-CoV-2 infection presenting with different symptomatology and epidemiological history will be recruited. Nasal, deep saliva and/or mouth gargle samples will be collected from all recruited subjects in accordance with standard clinical protocol. The samples would be tested for SARS-CoV-2 by the new Point-of-care test, in parallel with standard diagnostic testing of the hospital.

Eligibility Criteria:
Inclusion Criteria:

* adult patients admitted to isolation wards of the hospital who are
* of age of 18 or above;
* presentation with symptoms of COVID-19 and/or
* demonstration of exposure risk to SARS-CoV-2 infection.

Exclusion Criteria:

* inability to communicate in English or Chinese;
* known history of mental illness;
* prisoners.
A Study to Investigate Safety and Tolerability of SH3809 Tablet in Patients With Advanced Solid Tumors

The primary objective is to determine the safety and tolerability of SH3809 in subjects with advanced solid tumors. The second objective is to evaluate the PK profile and preliminary efficacy of SH3809 in solid tumors.

This is a phase I, open-label study to assess the safety,tolerability, pharmacokinetics and preliminary efficacy of SH3809 tablet, a small molecule inhibitor of SHP2 receptor , in patients with advanced solid tumors.

Eligibility Criteria:
Inclusion Criteria:

1. Age between 18 and 75 years inclusive;
2. Histologically or cytologically confirmed advanced malignant solid tumors, eligible patients should be either refractory or intolerant to all available therapies known to confer a clinical benefit as determined by the investigator, except for primary hepatic carcinoma;
3. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1;
4. Life expectancy ≥ 3 months;
5. Adequate hematologic, hepatic and renal function;
6. Participant willing to agree to not father a child/become pregnant and comply with effective contraception criteria;
7. Provision of signed and dated, written informed consent prior to any study-specific evaluation.

Exclusion Criteria:

1. Previous treatment with any SHP2 inhibitors;
2. Spinal cord compression, meningeal metastases or brain metastases unless asymptomatic, stable and not requiring steroids for at least 2 weeks prior to start of study treatment;
3. Life-threatening autoimmune disease or autoimmune disorder with long-term steroid treatment;
4. Active infection with hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV) and treponema pallidum (TP);
5. Patients who have impaired cardiac function or clinically significant cardiac diseases;
6. Active, clinically significant interstitial lung disease or pneumonitis;
7. Females who are pregnant or breastfeeding;
8. Judgment by the investigator that the patient should not participate in the study.
Arabic Version of the ICOAP Questionnaire

A study to translate and cross-culturally adapt the Intermittent and Constant Osteoarthritis Pain (ICOAP) measurement tool into the Arabic language, and assess its psychometric properties.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants must meet the knee and hip osteoarthritis (OA) diagnostic criteria according to the American College of Rheumatology (ACR).

Exclusion Criteria:

1. rheumatoid arthritis
2. serious pathological conditions (inflammatory arthritis and malignancy)
3. total or partial arthroplasty of the affected joint
4. individuals who cannot read and understand documents written in the Arabic language.
Study of Therapeutic Exercise in Acute Respiratory Failure to Improve Neuromuscular Disability Trial

This is a stepped-wedge, cluster randomized, trial evaluating the effect of an early goal-directed mobilization intervention for ICU patients with acute respiratory failure within 12 medical and surgical ICUs across 4 hospitals in the University of Pennsylvania Health System. The investigators will conduct a 54-week trial to measure the effect of the intervention on multiple patient-centered outcomes of patient physical function and cognition, in addition to ICU and hospital length of stay and duration of mechanical ventilation compared to usual care.

The STAND trial aims to measure the effect of an early goal-directed mobilization algorithm versus usual care for ICU patients with acute respiratory failure in the medical and surgical ICUs across University of Pennsylvania Health System (UPHS) with respect to patient-centered outcomes of patient physical function and cognition as well as multiple secondary clinical outcomes. To achieve this goal, the investigators will conduct a 54-week stepped-wedge, cluster randomized, trial to test the intervention during the course of providing usual care among a large and diverse population of patients admitted to 12 ICUs across 4 hospitals within UPHS. The intervention is an early mobilization protocol implemented during a patient's stay in the ICU. It involves three steps: 1) the clinical team will set a standardized mobility goal for each patient during morning rounds and display the goal on the patient's door; 2) a facilitator will be established in the ICU to communicate mobility goals and activities across clinical personnel shifts; 3) patient mobility scores will be displayed to clinical and administrative staff in the ICU via the ICU board. Approximately 1,500 adult patients with continuous mechanical ventilation for ≥48 hours (without interruption) and baseline independent ambulatory status will be enrolled. Participating ICUs will be randomized into 6 clusters of 2 ICUs each. Each ICU contributes a minimum of 12 weeks of data under the usual care control condition prior to implementing the early mobilization intervention. Then, using the stepped-wedge design, all ICUs will implement the intervention in 6-week intervals with the order and timing of implementation determined by random assignment. By the end of the trial, all ICUs will have utilized the intervention for at least 12 weeks. The primary outcome is peak patient activity level as measure by the ICU mobility score (IMS) at ICU discharge. Secondary outcomes include an array of clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old; AND
* Admission to 1 of 12 participating ICUs; AND
* Continuous mechanical ventilation for ≥ 48 hours (without interruption); AND
* Baseline independent ambulatory status

Exclusion Criteria:

* Admitting diagnosis of any of the following conditions:

  * Cardiopulmonary arrest
  * Raised intracranial pressure
  * Acute neurological admission diagnosis
  * Subarachnoid hemorrhage
  * Ischemic stroke
Low-dose Laxative Improves Performance and Feasibility of Computed Tomography Colonography (CTC)

The aim of this study is to evaluate a low-dose of bowel preparation for Computed Tomography Colonography (CTC) versus free laxative CTC with regard to performance, feasibility, patient tolerability and acceptance.

Computed Tomography Colonography (CTC) is a valid alternative to colonoscopy in the detection of cancer, polyps and other colon lesions.

High volume cathartic preparations, low volume cathartic solutions with oral tagging agent and tagging agent only are the procedures available for CTC.

High volume preparations are a considerable burden for patients. Low volume cathartic solutions are more accepted by the patients, reduce the amount of tagging agent and the waiting time to the exam. Tagging agent only preparations represent a risk if they are taken without medical supervision.

Eligibility Criteria:
Inclusion Criteria:

* Out-patients undergoing a CTC
* Patient written informed consent

Exclusion Criteria:

* Pregnant or lactating women or at a risk of becoming pregnant
* Known or suspected gastrointestinal obstruction or perforation, toxic megacolon, ileo, major colonic surgery
* History of anaphylaxis to Iopamidol or allergic reactions to drugs
Microglial Cells Activation Imaging Using PET-CT With 18F-DPA714

There is accumulating evidence suggesting that inflammatory processes, through microglial activation, would play a key role in brain injury and degeneration. It is considered that microglial activation would be part of self-propelling cycle of neuroinflammation that fuels Neurologic deterioration. It is however hard to evidence microglial activation in vivo: first, the investigators need very high-resolution imaging tools and then, the only ligand available to date, 11C-PK11195, has a low sensitivity and specificity and provided heterogeneous results. 18F-DPA-714 is a new PET ligand which labels microglial cells. The investigators aim to explore the clinical feasibility used PET-CT with 18F-DPA714 to monitor microglial cells activation of brain in several different disease. This study might reveal significant neuroinflammatory process in the brain. The results of this study might provide a new biomarker of disease pathological progression and help as identifying subjects who might most benefit from a specific anti-inflammatory drug.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Positron emission tomography scans were acquired more than twice
* Written informed consent was provided by the patients and their health care proxies -

Exclusion Criteria:

* Contraindication for PET examination
Chronic Granulomatous Disease Study in China

CGD is a rare inherited primary immunodeficiency which is caused by the defect in one of the subunits of NADPH oxidase complex.We tend to collect and analyze Chinese CGD patients who are diagnosed in hospitals affiliated to Shanghai Jiao Tong University School of Medicine, including clinical feature, laboratory data and genetic information. we aim to find out clinical, distribution, genetic characteristic of CGD in Chinese population, etc., thus further improving the level of diagnosis and treatment for CGD.


Eligibility Criteria:
Inclusion Criteria:

* x-linked and AR-linked Chronic Granulomatous Disease
* history of life-threatening severe infections
* A functional assay demonstrating abnormal NADPH oxidase function or clinical history consistent with CGD

Exclusion Criteria:

* Presence of other primary immunodeficiency syndromes that do not meet the clinical and laboratory criteria for CGD.
A Study of INCB050465 in Primary Sjögren's Syndrome

The purpose of this study is to assess the impact of parsaclisib on the signs and symptoms of Sjögren's syndrome (SS).


Eligibility Criteria:
Inclusion Criteria:

* Primary SS diagnosed according to the revised American-European Consensus Group (AECG) criteria.
* Minimum score of 2 on the SGUS score for parotid and submandibular glands.
* EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI) score ≥ 5.
* Positive serum titers of anti-SS-A and/or anti-SS-B antibodies.
* Symptomatic oral dryness score of at least 5 on patient questionnaire.
* Willingness to avoid pregnancy or fathering children based on protocol-defined criteria.

Exclusion Criteria:

* Diagnosis of secondary SS according to the revised AECG criteria (eg, the presence of a previously diagnosed or a present diagnosis of rheumatoid arthritis, systemic lupus erythematosus, systemic sclerosis, mixed connective tissue disease, polymyositis, dermatomyositis, immunoglobulin G4-related disorder, sarcoidosis, or any other defined autoimmune rheumatologic disorder).
* Concurrent conditions and history of other diseases per protocol-defined criteria.
* Positive test results for tuberculosis (TB) from the QuantiFERON-TB Gold test or T-spot.TB test.
* Positive serology test results for HIV antibody, hepatitis B surface antigen, hepatitis B surface antigen antibody, HBV core antibody, or HCV (HCV antibody with positive HCV-RNA).
* Severely impaired liver function (Child-Pugh Class C).
* Prior or ongoing therapy with protocol-defined drugs.
* Receipt of any live vaccine in the 30 days before screening.
* No major surgery within 30 days before screening. Inadequate recovery from toxicity and/or complications from a major surgery before starting therapy.
* Current alcohol or drug use that, in the opinion of the investigator, will interfere with the participant's ability to comply with the dose regimen and study evaluations.
* Laboratory values at screening outside the protocol-defined ranges.
Genotype-phenotype Characterization Study on Genetic Diseases With Immune and Neurological Dysfunctions

Over the past twenty years, Prof. Yanick Crow and his team have developed internationally recognized expertise in genetic pathologies affecting the immune and neurological systems. The pathologies studied have a particularly severe impact on patients' quality of life, with a high mortality rate and a significant risk of occurrence in affected families. These pathologies are rare, and very often under-diagnosed. To date, there is virtually no effective curative treatment.

Prof. Crow's team operates at the frontier between clinical and research work, and from experience, the team knows that patients and families affected by these serious pathologies are often highly motivated to help research into the pathology that affects them.

Initially, Prof. Crow's research focused primarily on the study of the genetic disease Aicardi-Goutières Syndrome (AGS). However, there is an undeniable clinical and pathological overlap between AGS and other forms of disease such as autoimmune systemic lupus erythematosus and many other genetic pathologies - e.g. familial lupus engelure, spondyloenchondromatosis and COPA syndrome. This is why research is being extended to all genetic diseases with immune and neurological dysfunctions.

The research methodology is classic with regard to many genetic clinical studies, and aims to:

* clinically define the phenotypes of these diseases (in this case, genetic diseases with immune and neurological dysfunctions)
* identify the gene(s) responsible for each disease
* Understand how changes in these genes and protein functions cause these diseases.

It is possible that this research will ultimately lead to the creation of diagnostic tests (e.g. molecular diagnostic screening tests) and treatments that would be clinically very useful for the patients participating in the project. These discoveries could also improve our knowledge of other more common pathologies, particularly those associated with autoimmunity (e.g. when the body increases an immune response against its own tissues).

As a complement to this global research project, Prof. Crow's team intends to study cell populations from patients with no inflammatory pathology, in order to analyze their basal levels of immune and inflammatory mediator production, as well as to assess their capacity (kinetics and amplitude) to respond to stimuli.

Eligibility Criteria:
Inclusion criteria

* Patients :

  * Have / present a family history of genetic disease with immune and neurological dysfunction.
  * Have signed an informed consent form.
* Unaffected related subjects :

  * Be related to a patient included in this research.
  * Have signed an informed consent form.
* Control patients

  * Be free of any genetic disease with immune and neurological dysfunction.
  * Have undergone surgery as part of their management
  * Have signed an informed consent form.

Non-inclusion criteria

✓ Be deprived of liberty
TekiTrust Tests to Determine the Level of SARS-COV-2/COVID-19 Neutralizing Antibodies in the Blood

The purpose of this study is to determine if the TekiTrust Enzyme-Linked Immunosorbent Assay (ELISA) Kit and TekiTrust Rapid Test can accurately determine the amount of antibodies to fight the COVID-19 virus in sampled blood compared to the standard Plaque Reduction Neutralization Test (PRNT) test.

When a person has COVID-19 they develop antibodies to the virus which are contained in their blood stream. After a certain period, the number of antibodies to fight (neutralize) the virus begin to decrease. One common way to measure the amount of antibodies in the blood is to use a test called the PRNT. The focus of this study is to compare the ability of the TekiTrust ELISA Kit and the TekiTrust Rapid Test with the PRNT to determine if these tests can measure the antibodies equally well.

Participants who have been previously diagnosed with COVID-19 within the past 3 months through any FDA emergency use approved (EUA) assay test will eligible for inclusion in the study. A blood and fingerstick sample will be obtained from the participant and for subjects with a positive test and symptom onset of less than 30 days a repeat RT-PCR nasal pharyngeal swab sample will be taken. The fingerstick sample will be used onsite by qualified site staff to test the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection Rapid Test. These results will be compared to the whole blood sample sent to the lab which will be analysed for SARS CoV-2 neutralizing antibodies using the TekiTrust SARS-CoV-2 Neutralizing Antibody Detection ELISA Kit and the comparator Plaque Reduction Neutralization Test (PRNT) test.

Eligibility Criteria:
Inclusion Criteria:

1. ≥ 18 years of age
2. Able and willing to provide written informed consent
3. Previously diagnosed as SARS-CoV-2 positive by any FDA EUA approved assay with a symptom onset date within the previous 30 days and who are willing to provide a nasopharyngeal swab for RT-PCR testing
4. Suspected of previous SARS-CoV-2 infection and willing to provide a nasopharyngeal swab for RT-PCR testing
5. Previously diagnosed as SARS-CoV-2 positive by a FDA EUA approved RT-PCR assay with a symptom onset date greater than 30 days and a known date of PCR sample collection and symptom severity

Exclusion Criteria:

1. Any significant medical, psychological, or social condition which in the opinion of the investigator may preclude the subject from participating in the trial
A Study of the Rate of Progression of Glaucoma During a Follow-up Period of Two Years

This is an epidemiological, non-interventional, prospective study to collect data on glaucoma progression in a routine setting. Patients may receive treatment at the discretion of their physician per local standard of care.


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma in one or both eyes

Exclusion Criteria:

* Participation in a glaucoma therapeutic clinical trial
Efficacy of Topical Tranexamic Acid in Reducing Blood Loss During CS in Patients With Placenta Previa

Objectives: To evaluate the efficacy of topical tranexamic acid applied on the placental bed after placental delivery to reduce blood loss during cesarean delivery in women with placenta previa.

Patients will be randomly assigned into two groups:

Group (A) - Study group (n=28): The topical tranexamic acid group will receive topical tranexamic acid after placental delivery applied on the placental bed for 5 minutes by using a sterile towel soaked with 2g tranexamic acid (Kapron, Amoun, Cairo, Egypt) (4 ampules 500ug) diluted in 100ml of sodium chloride 0.9%, in addition to the IV infusion of 1g tranexamic acid (2 ampules 500ug) diluted with 20ml of 5% glucose administered just after delivery of the fetus.

Group (B) - Control group (n=28): The intravenous tranexamic acid group will receive only an IV infusion of 1g of tranexamic acid (2 ampules 500ug) diluted with 20 ml of 5% glucose administered just after delivery of the fetus.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20-40 years old.
* BMI less than 30 kg/m2.
* Pregnancy of singleton living fetus.
* Placenta previa by ultrasound assessment
* Gestational age \> 36 weeks.

Exclusion Criteria:

* Women with a history of any medical disorder with pregnancy, e.g., Gestational diabetes and hypertension.
* Women with systemic diseases, e.g., diabetes mellites, systemic immune disorders such as systemic lupus erythematosus
* Women with bleeding tendency or coagulopathy.
* Women on anticoagulants or hemodynamically unstable women.
* Women with uterine abnormalities, such as fibroids or polyps.
* Emergency termination of pregnancy.
* Intrauterine fetal death.
* Pregnancy with obstetric hemorrhage, e.g., antepartum hemorrhage
* Cases of placenta accrete spectrum disorder or placental abruption
* Women with known allergies to Tranexamic acid