cyrilzakka/clinical-trials huggingface dataset:
Clinical Study of EBV-TCR-T Cells for EBV Infection After Allogenic HSCT

This is a multi-center, single arm, open-label, phase I study to determine the safety and effectiveness of EBV-TCR-T cell immunotherapy in treating EBV virus infection after allogenic HSCT.

EB virus (EBV) infection after allogeneic hematopoietic stem cell transplantation (HSCT) is common and can be lethal without prompt treatment. In this prospective study, HLA-A\*02:01/11:01/24:02-restricted EBV-specific T cell receptor (TCR) will be introduced into the T cells of HSCT donors by ex vivo lentiviral transduction to generate EBV-TCR-T cells. An escalated dose ranging from 3×10\^5/kg to 1×10\^6/kg of EBV-TCR-T cells will be infused into patients with EBV infection. The safety, efficacy, pharmacokinetics and cytokine levels of allogenic EBV-TCR-T cell therapy will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age 14-75 years, gender unlimited.
* Diagnosed with hematologic malignancies and have undergone allogeneic hematopoietic stem cell transplantation (allo-HSCT), with EBV infection after allo-HSCT.
* Karnofsky Score ≥ 70(age ≥16y) or Lansky Score ≥ 50(age\<16y).
* TCR-T cell donor inclusion criteria: 1) Age 8-70 years; 2) Understand and voluntarily sign informed consent and are willing to comply with laboratory tests and other research procedures; 3) ≥ 3/6 HLA match with TCR-T cell recipients enrolled; 4) Lymphocyte count = (0.8\~4) × 10\^9/L; 5) Have sufficient venous circulation, without any symptoms that do not allow blood cell isolation.

Exclusion Criteria:

* Patients with uncontrolled active aGVHD one day before TCR-T cell infusion.
* Patients with severe kidney disease (Cr \> 3×normal value), liver damage (TBIL \>2.5×upper limit of normal value, ALT and AST \> 3×upper limit of normal value) or heart failure (NYHA heart function grade IV) one week before TCR-T cell infusion.
* Anticipated to take immunosuppressive hormones on the day of TCR-T cell infusion.
* Have other malignancies.
* Have relapsed and uncontrolled hematologic malignancies.
* Serologically positive for HIV-Ab or TAP-ab.
* Pregnant or lactating women.
* Anticipated to have other cell therapies in 4 week post TCR-T cell infusion.
* Participated in any other clinical study of drugs and medical devices before 30 days of enrollment.
Oxygenation in Vascular Lesions of the Colon

The goal of this clinical trial is to evaluate oxygenation in the colon in people with acquired vascular abnormalities in the proximal colon.

The etiology of acquired vascular abnormalities of the large bowel (i.e. angiodysplasia, AVM, hemangiomas of the cecum. etc.) are unknown. These lesions typical appear as ectatic, dilated, and tortuous blood vessels within the submucosa and mucosa of the GI tract. In some patients they are the cause of acute large volume bleeding or a slower chronic bleed that manifests as chronic iron deficiency anemia. These lesions are more common in older individuals and those with underlying cardiac, pulmonary, and renal disease. As such, it is hypothesized that these lesions may result from chronic hypoxia. This study aims to evaluate oxygenation of the colon in people with acquired vascular abnormalities in the proximal colon compared to healthy controls.

Eligibility Criteria:
Inclusion Criteria:

* Undergo standard of care colonoscopy
* People with a history of vascular lesions of the colon
* People with healthy colon
* 18 - 89 years of age

Exclusion Criteria:

* Age \< 18 years
* Age \> 90 years
* People with ulcerations in at ascending colon opposite the ileocecal valve
* Previous colon surgery
Discovering Novel Cancer Treatment Options Using a Comprehensive NGS-based Liquid Molecular Testing Panel in the Community Setting ("DINOSAur II")

To prospectively identify cancer patients whose tumors express specific molecular markers targeted by therapeutic agents from a comprehensive l i q u i d molecular test, for the purpose of selecting the most clinically appropriate treatment in a pragmatic two arm trial.


Eligibility Criteria:
Inclusion Criteria:

* Patients who have given informed consent in accordance with the methods and procedures of this study
* Diagnosis of cancer (stage 3 and stage 4; solid tumors only) requiring medical care
* Patients who have not received treatment related to his/her cancer
* Patients who are willing to sign a release of medical records to the research team
* Male and female patients ≥18 years of age
* Patients under oncology care
* Sufficient clinical status for collection of blood sample within usual care

Exclusion Criteria:

* Patients considered minors in the jurisdiction where the protocol is conducted
* Patients who are prisoners and pregnant women
* Patients who cannot provide consent and did not sign a power of attorney
CALYPSO Pilot Study: Machine Learning Based Predictions of Surgical Complications

This is a pilot study of surgical patients whose postoperative care will be augmented with a personalized risk prediction platform (CALYPSO app).

CALYPSO is a software platform that uses machine learning techniques to create personalized risk predictions for postoperative complications. Individual risk factors are then linked to best-practice interventions tailored to the individual patient. The investigator aims to test the hypothesis that using CALYPSO-augmented postoperative care will reduce complication rates in patients undergoing elective general surgery. Subjects undergoing surgery will be assigned to the CALYPSO intervention in the postoperative period.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age
* Undergoing elective surgery
* Undergoing high risk colon, rectal, pancreas, gastric surgery with predicted length of stay greater or equal to 3 days

Exclusion Criteria:

* Surgeries with less than 3 days of anticipated length of stay (e.g. stoma takedown)
Chest Compressor for Conservative Treatment of Pectus Carinatum: a Multicenter Study

Pectus carinatum (PC) is a congenital deformity of the chest wall whose prevalence is 0.6% of the population and although it does not cause cardio respiratory physiological damage, it has profound psychological effects on young people. Its treatment today is still primarily surgical in our country, despite the fact that conservative treatment by chest compression may be effective in the chondrogladiolar variant, which represents 90% of cases of PC. The aim of the present study is to conservatively treat a series of 60 patients using a new modular and adjustable chest compressor model to assess the effectiveness of this chest compressor in the noninvasive treatment of PC; and also assess the safety of such treatment by the rate of adverse events occurring during treatment. Secondary objectives will be to evaluate the adherence that PC patients have to this type of treatment by quantifying the number of hours of use per day, besides evaluating the chest compressor and its components for durability and resistance as a device for continuous use.


Eligibility Criteria:
Inclusion Criteria:

* Pectus carinatum condrogladiolar Variant
* No other comorbidities that could interfere with the use of compressor

Exclusion Criteria:

* Marfan Syndrome
* Active cardiovascular disease
* Significant scoliosis or thoracic deformity
* Important obesity
* Pectus carinatum chondromanubrial variant
* Poor commitment to protocol by both research participant and parents
Localization of Peripheral Pulmonary Lesions: A Pilot Study

Despite technological advancements directed towards the diagnosis of peripheral pulmonary lesions, an optimal approach has yet to be designed. One significant barrier for the bronchoscopic biopsy of peripheral lesions is the ability to reliably locate peripheral lesions in an efficient manner. The majority of the published literature regarding peripheral lesion biopsy has used diagnostic yield as the primary endpoint. Based on this data, it is unclear if non-diagnostic procedures are due to the inability to locate peripheral lesions, or due to the inability to successfully biopsy lesions once located using currently available instruments. This study will evaluate the bronchoscopists' ability to locate peripheral pulmonary lesions by using a conventional chest computed tomography (CT) scan as a reference and a virtual bronchoscopic navigational system, if needed, for the localization of peripheral pulmonary lesions.


Eligibility Criteria:
Inclusion Criteria:

* Patients with peripheral lung lesions 1-5cm in size identified on chest CT with the intention to undergo bronchoscopic evaluation and biopsy. The decision to pursue biopsy will be made by the treating physician and agreed upon by the patient.
* Are at least 18 years old
* Are able to provide informed consent
* Have CT scans within 30 days suitable for use with the virtual bronchoscopic system

Exclusion Criteria:

* Patients who refuse to participate
* Are less than 18 years of age
* Are pregnant
* Are physically unable to tolerate flexible bronchoscopy or moderate sedation as determined by the bronchoscopist
* Are unable to provide informed consent
A Therapeutic Equivalence Study in Subjects With Primary Open Angle Glaucoma or Ocular Hypertension

This is a randomized, Investigator-masked, multi-center, parallel group, therapeutic equivalence study with clinical endpoint.


Eligibility Criteria:
Inclusion Criteria:

* Male or nonpregnant female aged 18 years or older with chronic open angle glaucoma or ocular hypertension in both eyes.
* Provide signed and dated informed consent in accordance with good clinical practice and local legislation prior to any study procedure.
* Be able and willing to follow study instructions and complete all required visits.
* Subject requires treatment of both eyes and is able to discontinue use of all ocular hypotensive medication(s) or switch ocular hypotensive medications and undergo appropriate washout period.

Exclusion Criteria:

* Subjects with angle closure glaucoma
* Females who are pregnant, breast feeding, or planning a pregnancy.
* Females of childbearing potential who do not agree to utilize an adequate form of contraception.
* Current, or past history of, severe hepatic or renal impairment
* Current, or history within 2 months prior to baseline of, significant ocular disease
* Functionally significant visual field loss
* Contraindication to brinzolamide or sulfonamide therapy or known hypersensitivity to any component of brinzolamide or sulfonamide therapy
* Subjects currently in another clinical trial
Influence of an Acidic Beverage on the Imatinib Exposure After Major Gastrectomy

The most common sites for GIST to occur are the stomach (60-70%) and proximal small intestines (20-25%). Therefore patients with GIST often have altered GI-tract due to tumor resection or palliative surgery which might affect imatinib exposure. Indeed, Yoo et al. showed that steady state imatinib trough levels in patients with advanced GISTs after major gastrectomy are lower compared to patients with a previous wedge resection or without gastric surgery. Patients that underwent major gastrectomy had an average imatinib plasma trough levels below 1000 µg/L. This while imatinib trough levels above 1000 µg/L are correlated to more beneficial treatment out-comes (longer Progression Free Survival).

Since imatinib easily and rapidly dissolves at pH 5.5 or less, a lack of gastric acid secretion might be causing the decreased exposure in the patients that underwent major gastrectomy.

Therefore the investigators would like to study if the exposure to imatinib in patients after major gastrectomy can be improved by creating a more acidic environment for absorption through combining imatinib intake with Coca-Cola.


Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ≥ 18 years of age
* Patients with GIST, who previously underwent major gastrectomy
* Eastern Cooperative Oncology Group (ECOG) performance status (PS) of 0-1
* Already selected to receive imatinib therapy in a dose of 400-800mg imatinib daily, as judged by the treating physician and with respect for and in agreement with the registration guidelines
* Subject is able and willing to sign the Informed Consent Form prior to screening

Exclusion Criteria:

* Concomitant administration of any anti-cancer therapies (e.g. chemo-therapy, other targeted therapy, experimental drug, etc) other than imatinib
* Concomitant use of medication which strongly inhibits or induces CYP3A4
* Refractory nausea and vomiting, malabsorption with other causes than gastrectomy or external biliary shunt that would preclude adequate absorption.
* Unwillingness to use Coca-Cola
* Unwillingness or inability to swallow whole tablets
* Inability to comply with the requirements of the protocol
* Inability to understand the nature and extent of the study and the procedures required
* Participation in a drug study within 60 days prior to the first day of this study
Clinical Trial of GX-I7 in Healthy Volunteers

This is a Phase 1, randomized, double-blind, placebo-controlled, single ascending dose study designed to assess the safety, tolerability, pharmacokinetics and pharmacodynamics of GX-I7 in healthy volunteers.

The subjects who are adequately eligible to attend this clinical trial via screening will be hospitalized one day prior to the injection (Day -1), administered a single dose of GX-I7 solution for subcutaneous injection, and then discharged on Day 3. After completing all scheduled tests at the visit 8 (Day 28), safety-related data of each cohort will be evaluated by Independent Safety Monitoring Committee (SMC). Dose escalation will proceed under the principal investigator, medical monitor, and the sponsor's mutual approval, referring to SMC's evaluation.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is willing and able to give informed consent after listening character of the clinical trial
2. Must be 19-45 years of age, inclusive
3. Weight 50-100kg, BMI 18-30kg/m2
4. Subject who is adequately able to attend the study based on medical history and physical exam, no clinically significant abnormality from vital sign and clinical laboratory values
5. No clinical abnormality from ECG test
6. Non-smoker (no smoking or no use of any product containing nicotine least for one month and negative from urine test)

Exclusion Criteria:

1. Suspected or confirmed malignancy, or has malignancy history
2. Any clinically significant acute or chronic medical condition requiring care of a physician, in liver, biliary tract, renal, nervous system (CNS or peripheral). respiratory system, endocrine (diabetes, hyperlipidemia etc), cardiovascular (congestive heart failure, coronary artery disease, myocardial infarction etc), hematology, malignancy, urinary disease, mental disorder, musculoskeletal disorder, immune system (rheumatoid arthritis, lupus etc), otorhinolaryngologic diseases
3. Positive to HBsAg, hepatitis C virus (HCV) Ab and HIV Ab
4. Are considering or scheduled to undergo any surgical or dental procedure during the study
5. Administered other Investigational Product (IP) by attending other clinical study or biological equivalent study within recent 3 months
6. Any Serious adverse drug reaction (SAR) against vaccines or antibiotics, any medical history with serious allergic diseases
7. Positive from urine drug screen or respiratory alcohol screen at medical screening or check-in
8. History of alcohol, drug, or substance abuse in the past 12 months
9. Consumption of alcohol within 48 hours prior to hospitalization
10. Medications with antacid, analgesic, herbal treatment, vitamin, mineral (except maximum 4 grams of acetaminophen) hormone, steroids, insulin, hypoglycemic drug or other hormone substitute within 14 days before administration
11. Planning pregnancy or donation of sperm/disagreeing proper contraception during the study and 3 months following IP administration
12. Do not have veins suitable for cannulation or multiple venipunctures
13. Any other factor that the Investigator thinks will increase subject risk with participation
Arterial Stiffness in Patients With Sepsis

To investigate whether arterial stiffness, as defined by measuring Pulse Wave Velocity, could be identified as an independent risk factor for development of acute kidney injury in sepsis.

To compare between the Pulse Wave Velocity and shear wave ultrasound elastography (SWE) as a different methods of evaluation of arterial stiffness in prediction of acute kidney injury in sepsis.

Demographic and historical data: the patient age, sex, history of hypertension, diabetes ,peripheral vascular disease , IHD, source of sepsis and indication of mechanical ventilation if indicated.

Clinical examination data: pulse, blood pressure, respiratory rate, temperature and thorough chest, cardiac and neurological examination data will be obtained.

Volume state of the patient: CVP measurement, input and output fluid chart. Investigation : CBC( Neutrophil count, Neutrophil/lymphocyte ratio), Blood urea and serum creatinine ,serum electrolytes, serum lactate,serum albumin,CRP ,coagualtion profile and lipid profile. sequential organ failure assessment (SOFA) score, acute physiology and chronic health evaluation (APACHE II) score, and complete sepsis workup to identify the possible sources of sepsis.

12 lead ECG and Echocardiographic data that include: Left and right atrial dimensions. The left ventricular ejection fraction will be assessed by the Simpson method, left ventricular diastolic function will be assessed by measuring velocities of the mitral E and A waves and of the e' wave of the external mitral annulus and by calculating the E/e' ratio. Right ventricle dimension and dysfunction will be evaluated by TAPSE and pulmonary artery acceleration time. Pulmonary artery pressure will be measured from Tricuspid flow if possible.

Pulse Wave Velocity (PWV), a measurement of arterial stiffness, will be assessed at the systemic region (carotid-femoral PWV), which is the gold standard method. In the first 24 hours of admission.

The two-dimensional SWE technique will be used in our study , an imaging method will be obtained by simultaneously applying multiple ARFI waves into the tissue and measuring the resulting shear waves .It will be assessed in the first 24 hours of admission.

RRI will be measured at the time of admission. All measurements will be performed by the same examiner and repeated by an independent blinded operator. Using pulse-wave Doppler, an interlobar or arcuate artery will be selected. RRI will be calculated as the equation "(PSV-EDV)/PSV". The means of three distinct RRI calculations will be recorded.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients who admitted to critical care unit of Internal medicine department with sepsis after obtaining consent.

Exclusion Criteria:

* Children below 18 yr.
* Patients could not be scanned within 24-h after ICU admission.
* Patients with end stage renal disease or transplanted kidney.
* patients with renal artery stenosis, and obstructive uropathy
A Study for Multiple Tablet Forms of The Study Medicine (PF-07220060) in Healthy Adults

The purpose of this study is to compare multiple formulations of PF-07220060 in terms of their uptake into the blood stream. The study will assess the effects of food and Rabeprazole on the uptake of PF-07220060. Rabeprazole belongs to a type of medications called proton pump inhibitors. In reality, some patients may take both PF-07220060 and rabeprazole together.

This study is seeking participants that are:

- Healthy male or female aged 18 to 65 years

Participants in this study will receive PF-07220060 once or twice by mouth. The participants may receive different tablets for PF-07220060. Some participants will take a meal before receiving PF-07220060. In addition, some participants will take rabeprazole by mouth for 7 days before taking PF-07220060.

The study will compare experiences of people receiving different formulations of PF-07220060. Experiences of people taking food and rabeprazole with PF-07220060 will be compared to those on PF-07220060 alone. This will help understand how much PF-07220060 is taken up into the blood. It will also help understand how meal and Rabeprazole medicine changes the uptake of PF-07220060 into the blood.

Participants will take part in the study for a maximum of 74 days. During this time, they will have to stay onsite for 5 to 13 days. There will be up to 2 onsite study visits.


Eligibility Criteria:
Inclusion Criteria:

* Male and female participants who are overtly healthy as determined by medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring
* BMI of 17.5-30.5 kg/m2; and a total body weight \>50 kg (110 lb).
* Evidence of a personally signed and dated ICD indicating that the participant has been informed of all pertinent aspects of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at the time of dosing).
* Any condition possibly affecting drug absorption (eg, gastrectomy, cholecystectomy).
* History of human immunodeficiency virus (HIV) infection, hepatitis B, or hepatitis C; positive testing for HIV, hepatitis B surface antigen (HBsAg), or hepatitis B surface antigen (HCVAb). Hepatitis B vaccination is allowed.
* Any medical or psychiatric condition including recent (within the past year) or active suicidal ideation/behavior or laboratory abnormality or other conditions that may increase the risk of study participation or, in the investigator's judgment, make the participant inappropriate for the study.

Prior/Concomitant Therapy:

* Use of prescription or nonprescription drugs and dietary and herbal supplements within 7 days or 5 half-lives (whichever is longer) prior to the first dose of study intervention.
* Previous exposure to PF-07220060 or participation in studies requiring PF-07220060 administration.
* A positive urine drug test/urine cotinine test.
Children to Adults Mental and Psychosomatic Health Study (CAMPS)

This study titled the Children to Adults Mental and Psychosomatic Health Study (CAMPS), aims to explore the interplay between mental health, psychosomatic factors, and adverse childhood experiences (ACE) across a broad age range, from school-age children to adults in China. The study will involve participants from various educational settings, including teachers, students, and parents, who will be recruited through schools. The assessment methodology will combine validated psychometric scales and behavioral experiments to comprehensively evaluate mental and physical health aspects and the impact of ACEs. This integrative approach is designed to illuminate the complex relationships between psychological well-being, somatic symptoms, and early life stressors across different life stages.


Eligibility Criteria:
Inclusion Criteria:

1. Students from 5 grade to 12 grade, their parents and teachers
2. able to read, answer questionnaires and complete experiments.

Exclusion Criteria:

a. Students who suspend schooling.