cyrilzakka/clinical-trials huggingface dataset:
A First-in-Human Study of JAB-3068 (SHP2 Inhibitor) in Adult Patients With Advanced Solid Tumors in China

This is a Phase 1/2a, open-label, multi-center study of JAB-3068 in Patients with advanced solid tumors.This study has two phases: dose escalation phase and dose expansion phase.

Dose escalation study phase is designed to determine the maximum tolerated dose (MTD) according to a 3+3 design and recommended phase II dose (RP2D) and to characterize the safety, tolerability, and pharmacokinetics (PK) profile of JAB-3068. Other dose regimens may be explored based on the analysis of emerging PK and safety data. at this study phase, JAB-3068 dministered orally once daily (QD) or twice daily (BID) or once every other day (QOD) in 28-day treatment cycles to adult patients with advanced solid tumors,

Dose expansion study phase is designed to evaluate the antitumor activity(ORR and DOR) of JAB-3068 in patients with NSCLC, ESCC and HNSCC.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained prior to any study-related procedure being performed;
2. Age 18 years or older;
3. Dose escalation(phase I): Patients with histologically or cytologically confirmed, advanced solid tumors (including lymphoma) which have progressed from standard therapy or for whom no standard therapy exists; Dose expansion(phase IIa ): Patients with histologically or cytologically confirmed, advanced NSCLC, ESCC, HNSCC which have progressed from standard therapy;
4. Patients with life expectancy ≥3 months;
5. Dose expansion(phase IIa ): patients have available archival tissue can be provided or willing to perform biopsy to provide fresh tumor tissue.
6. Patients with other solid tumors must have at least one measurable lesion as defined by RECIST v1.1;Patients with Lymphomas must have at least one measurable lesion as defined by IWG 2007 criteria;
7. Eastern Cooperative Oncology Group performance score 0 or 1;
8. Patients who have sufficient baseline organ function.

Exclusion Criteria:

1. Patients with life-threatening autoimmune disease or with autoimmune disorder and who are on long-term steroid treatment;
2. History or current evidence of retinal vein occlusion (RVO) or current risk factors for RVO;
3. Lymphoma with brain metastasis; Other solid tumors:Known malignant central nervous system (CNS) disease other than neurologically stable, treated brain metastases;
4. Active infection including hepatitis B, hepatitis C and human immunodeficiency virus (HIV)
5. Patients who have any severe and/or uncontrolled medical conditions or other conditions that, in the opinion of the Investigator and Sponsor, could affect the patient's participation in the study
6. Patients who have impaired cardiac function or clinically significant cardiac diseases
7. Use of anti-cancer treatment drug ≤21 days prior to the first dose of JAB-3068.
8. Use of an investigational drug during the past 30 days prior to the first dose of JAB-3068.
Supportive Understanding and Patient-centered Partnership for Optimizing Renal Treatment

Black and Hispanic people face higher risks of chronic kidney disease (CKD) but have unequal access to the highest-quality kidney care. Black adults with CKD face 1.5 times higher hospitalization risks than non-Black adults with CKD. Once reaching end stage kidney disease (ESKD), Black patients are half as likely to receive a transplant and are often excluded from home dialysis. Structural racism creates complex barriers to optimal CKD care, providing an explanation for these findings. The Penn Medicine IMPaCT Community Health Worker (CHW) program is a rigorously tested approach to employ people from local communities to dismantle structural racism within health care systems and improve outcomes for marginalized patients. This trial will innovate by training CHWs to focus specifically on CKD care for minoritized people. The investigators will also train primary care clinicians caring for CKD patients on how to provide trauma-informed care (TIC). The first aim is to determine the feasibility, acceptability, and reach of a clinic-level TIC training to address the needs and concerns of Black and other minoritized patients. The second aim will be to conduct a three arm trial comparing individuals in usual care to individuals randomized to either our tailored CHW intervention in conjunction with clinic-level TIC training or to clinic-level TIC intervention only. The investigators will examine whether patients in the intervention arms have greater improvements in quality of life (primary). The investigators will also explore the impact of the interventions on patient activation, hospitalizations, and ESKD treatment preferences.


Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney disease stage 4 or 5
* Patient at participating general internal medicine or family medicine clinic
* Medicaid-eligible or uninsured
* Reside in high poverty Philadelphia zip code

Exclusion Criteria:

* No history of kidney transplant
* Not receiving any form of dialysis
* Not previously enrolled with a community health worker in the past 2 years
A Comparison of Optive in Patients Previously Using Systane for the Treatment of Dry Eye

To evaluate the effectiveness of NGT (Optive) vs. Systane Tears for patients with moderate to severe dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* · Dry eye disease diagnosis

  * Patients must currently be using Systane tears at least once a day and for at least 1 month.
  * Normal lid position and closure
  * Male or female of legal age of consent
  * Informed consent has been obtained
  * Likely to complete all required follow-up visits

Exclusion Criteria:

* · Concurrent enrollment in an investigational drug or device study, or participation in such a study within 30 days of entry into this study.

  * Subject has a condition, or is in a situation which, in the investigator's opinion, may put the subject at a significant risk, may confound the study results, or may interfere significantly with the subject's participation in the study.
Cryo Balloon for Residual Barrett's Esophagus

This study is being done to see if treating residual Barrett's Esophagus after previously having undergone Radiofrequency ablation or Endoscopic Mucosal resection can be eliminated with focal cryotherapy.


Eligibility Criteria:
Inclusion criteria:

* Age \> 18 years old
* Able to provide informed consent
* Patients with unifocal or multifocal BE with 2 cm who have failed at least 2 serial RFA or other endoscopic therapy such as Endoscopic Mucosal resection,

Exclusion criteria:

* Age younger than 18 years old
* Presence of esophageal varices
* Esophageal stricture precluding passage of an endoscope
* Inability to provide informed consent
* Esophageal cancer (T2 and above)
* Coagulopathy with INR \> 2.0, thrombocytopenia with platelet counts \< 50,000
* Pregnancy (if required a pregnancy test would be performed as part of routine clinical care)
Ability of Hypotension Prediction Index to Predict Hypotension Events in Thoracic Surgery

Investigators design this prospective observational study to exam the ability of hypotension prediction index in predicting intraoperative hypotension events in each phase of thoracic surgery

Hypotension prediction index is a novel introduced monitoring-tool that aims to predict hypotension events before their occurence, and has been reported to have superior predictive ability than the commonly measured perioperative hemodynamic variables. To date, there is no information regarding its ability to predict hypotension events in each phase of thoracic surgery.

Eligibility Criteria:
Inclusion Criteria:

* adults undergoing scheduled VATS surgery

Exclusion Criteria:

* pregnant women
* patients in intensive care units
* patients with the underlying disease including respiratory failure(FEV1/FVC \< 70 % and FEV1 \< 50%), heart failure(NYHA score =III、IV), kidney failure(eGFR\< 60 ml.min-1.1.73m-2), liver failure
* patients with ongoing infection
Intervention in Frailty Versus Usual Care in Frail Patients After an Acute Myocardial Infarction

Frailty has been associated to a worse outcome in acute coronary syndromes, but the best management of frail patients after an acute coronary syndrome remains unknown. The aim was to investigate the benefit of an intervention on frailty in frail patients after an acute myocardial infarction.

Patients survivors after an acute myocardial infarction (with and without ST-segment elevation), older than 70 years and with pre-frailty (1-2 points) or frailty (≥3 points) according to the Fried's scale measured 24 hours before hospital discharge, will be included. The participants will be randomized to 2 strategies: a) intervention on frailty in addition to the usual care by the cardiologist, and b) conventional strategy consisting only of the usual care by the cardiologist. A multidisciplinary team (physicians, nurses and physiotherapists and nutritionists) will carry out the intervention on frailty The study contemplates a 2-year inclusion period and a 3rd year for the follow-up of the last included patient. The main outcome will be the frailty status (Fried's scale) at 3 months and 1 year. The secondary endpoint will be the clinical events, both cardiovascular and not cardiovascular events, including recurrent events (cumulative events analysis), for the total follow up (3 years in the case of the first included patient). The hypothesis is that an intervention on frailty will improve frailty status and the clinical outcomes in frail patients after an acute myocardial infarction.


Eligibility Criteria:
Inclusion Criteria:

* Admission for acute myocardial infarction and survivors in the hospitalization phase
* Age =\>70 years
* Prefrail or frail status (Fried scale =\>1 points)

Exclusion Criteria:

* Cognitive impairment (Pfeiffer test)
* Severe concomitant disease that could hamper the participation in the study
* Patient refusal to participate
MitraClip for the Treatment of Moderate Functional Mitral Regurgitation: EVOLVE-MR

This study evaluates the addition of transcatheter mitral valve repair with the MitraClip device to medical treatment in patients with heart failure and moderate functional mitral regurgitation to determine the impact of left ventricular remodelling and patients' functional capacity.

Moderate mitral regurgitation in patients with LV dysfunction is associated with increased risk of death and hospitalizations for heart failure (HF) and leads to progressive remodelling of an already damaged left ventricle. Medical therapies and cardiac resynchronization therapy (CRT) have demonstrated favourable effects on LV remodelling in heart failure patients.

Given the benefits and safety of transcatheter mitral valve repair with the MitraClip device in severe MR, it is conceivable that this technology could also be safely used in those with moderate MR to reduce mitral regurgitation, improve symptoms and result in LV remodelling. At present, the optimal treatment strategy for heart failure patients and moderate (2+, 2-3+) mitral regurgitation is uncertain therefore the EVOLVE-MR study proposes to evaluate transcatheter mitral valve repair with the MitraClip in such patients to study the effects on LV remodelling and functional capacity.

EVOLVE-MR is a randomized study of MitraClip and medical therapy in symptomatic heart failure patients with moderate (2+, 2-3+) secondary mitral regurgitation. The objective of this study is to determine the impact of both therapies on left ventricular remodelling and functional capacity of the target patient population.

Eligibility Criteria:
Inclusion Criteria:

* Moderate functional mitral regurgitation (2+, 2-3+)
* Left ventricular ejection fraction \>20%
* LVEDV 75-110 ml/m2
* Symptomatic heart failure (NYHA Class II-IV)

Exclusion Criteria:

* Left ventricular ejection fraction \< 20%
* Severe functional mitral regurgitation
* Recent coronary artery bypass graft surgery (CABG)
* Untreated significant coronary artery disease
* Mitral valve area \< 4.0cm2
* Severe pulmonary hypertension
Development of MRI Protocols and Associated Neuro-physiological Explorations in Healthy and Pathological Subjects

IRMaGe is a Joint Service Unit (UMS) which provides users of brain exploration equipment (clinical MRI and preclinical, TMS, EEG, NIRS and metabolomics). The methods available on this equipment are intended to evolve according to the most recent discoveries and this protocol aims to frame the developments necessary around clinical MRI for IRMaGe can continue to offer tools at the cutting edge of technology.

The studies will be carried out on healthy subjects and voluntary patients, who will have given their consent. Their main objective will be the development and optimization of sequence parameters or design stimulation paradigms in order to optimize the quality and relevance of the images produced taking into account the parameters anatomical, functional or metabolic while respecting the experimental constraints imposed by the protocol concerned (equipment of experimentation, additional physiological measurements, etc.). The main judgement criteria will be measurements inherent in the MRI sequence and a physiological measurement associated in the protocol concerned

Eligibility Criteria:
Inclusion Criteria:

* Participants with normal or corrected vision
* Participants affiliated to a social security scheme or beneficiaries of such a scheme
* Participants with French as their mother tongue
* Participants who have given the signed informed consent before carrying out any procedure related to the study.
* Volunteer patients will be recruited as part of their follow-up at the CHU. Their pathology will be in agreement with that of the research protocol to be optimized.

Exclusion Criteria:

Criteria relating to contraindications to the explorations provided for by the MRI protocol:

* metallic glitter in the eyes
* retinal operation
* claustrophobia
* wearer of pacemaker or cardiac defribrillator or vascular clip or prosthesis cardiac or insulin pump or implanted device to deliver medication or hearing implant or prosthesis or vascular shunt or paragraph or screws, plate metal or tattoo or piercing or implanted metal object or lead shot hunt

  * Alcohol ingestion before the examination
  * Pregnant, lactating and parturient women
  * Major protected by law
  * Participants under administrative or judicial supervision
  * Participation in another ongoing study if the study may interfere with participation in the protocol MAP-IRMaGe.
St. Jude Cancer Education for Children Program: Evaluation at 4th-Grade Level

The main objectives of the study is to

* Evaluate the knowledge acquisition and retention of 4th-grade students who participate in the St. Jude Cancer Education for Children Program
* To examine the relationship between outcome measures (knowledge acquisition and knowledge retention) with covariates of interest such as self-reported age and gender
* To compare the knowledge scores among schools and identify the schools that may show better improvement than others and factors associated with improvement

The subjects in this research study will be current 4th-grade students at elementary schools in Memphis, Tennessee who choose to participate in the Program. These participants are not patients of St. Jude Children's Research Hospital. The Program will be implemented over a three-day period. Each student will attend two presentations and six hands-on activities led by St. Jude faculty and research staff on topics within their expertise, such as cells and cancer, and healthy living. Printed materials to be distributed as part of the St. Jude Cancer Education for Children Program have been developed by a multi-disciplinary team of St. Jude employees and local educators and reviewed by national experts for scientific accuracy and appropriate readability. Material includes three illustrated children's books, a laboratory manual, and activity sheets.

One pre- and two post-tests will be administered by designated school teachers. The tests consist of 10 multiple-choice questions per each of three modules(cells, cancer, and healthy living), validated by a group of experts for readability and content relevance. Knowledge acquisition will be assessed by taking the differences from first post-test to pre-test scores, obtained from 10 questions on each component of the intervention, and using one-sample signed rank test to evaluate the improvement in the knowledge scores. A similar analysis will be undertaken by taking the differences from the 2nd post-evaluation to the 1st post-evaluation for each participant to assess knowledge retention.

Eligibility Criteria:
Inclusion Criteria:

Study participants are not patients of St. Jude Children's Research Hospital.

* 4th-grade student
* Enrolled at a school participating in the St. Jude Cancer Education for Children Program

Exclusion Criteria:

* Student chooses not to participate in any or all of the activities and/or testing
* Request by a parent or guardian
A Phase I First-in-Human Study of GenSci128 in Patients With Solid Tumors Harboring a TP53 Y220C Mutation

The purpose of this study is to Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of GenSci128 Tablet in Patients with Locally Advanced or Metastatic Solid Tumors Harboring a TP53 Y220C Mutation


Eligibility Criteria:
Inclusion Criteria:

1. Has the ability to understand and the willingness to sign a written informed consent document (prior to the initiation dose of GenSci128 and any study procedures)
2. Is willing and able to comply with the scheduled visits, treatment plan, laboratory tests and other specified study procedures
3. Has confirmed TP53 Y220C mutation in tumor tissue
4. Has histologically or cytologically confirmed locally advanced or metastatic solid tumors and have progressed following standard therapy, or for whom, in the opinion of the investigator, no available and effective standard therapy exists.
5. Has at least one measurable lesion by RECIST v1.1
6. Has an ECOG status of 0 or 1
7. Has a life expectancy of ≥ 3 months.

Exclusion Criteria:

1. Has diagnosed as primary central nervous system (CNS) tumor.
2. Has CNS metastases, unless asymptomatic, neurologically stable and not requiring steroids treatment for at least 2 weeks prior to initiation dose of GenSci128.
3. Has a history of leptomeningeal disease or spinal cord compression.
4. Has stroke or transient ischemic attack within 6 months prior to initiation dose of GenSci128.
5. Has active infection requiring intravenous (IV) antibiotics or other uncontrolled inter-current illness requiring hospitalization. Minor infections, e.g., periodontal infection or urinary tract infection (UTI), which may be treated with short term oral antibiotics are allowed.
6. Uncontrolled hypertension (Blood pressure ≥ 150/90 mmHg despite optimal medical management)
7. Has a history of prior organ transplant or allogeneic stem cell transplant.
8. Has received a selective reactivator of p53 Y220C mutation.
9. Has uncontrollable pleural effusion, pericardial effusion, or ascites requiring frequent drainage (recurrence ≤ 14 days after intervention).
10. Has known human immunodeficiency virus (HIV) infection (positive HIV 1/2 antibodies) or known chronic hepatitis B or C \[participants positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) will be eligible if they are negative for HBV-DNA; participants positive for hepatitis C virus (HCV) IgG will be eligible if they are negative for HCV-RNA\].
11. Is persisting toxicity related to prior anticancer therapy (NCI CTCAE V5.0 Grade\>1). However, alopecia and sensory neuropathy Grade ≤2, or other Grade ≤2 adverse events not constituting a safety risk, based on the investigator's judgment are acceptable.
12. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or GenSci128 administration or may interfere with the interpretation of study results, in the judgment of the investigator, would make the participant inappropriate for entry into this study.
Ejaculation Preservation After Laser Enucleation Prostate

A multicentre randomised controlled trial evaluating the benefit of median lobe preservation on the incidence of retrograde ejaculation during prostate enucleation by HoLEP.

The main objective of the study is to compare the incidence of retrograde ejaculation at 6 months in patients undergoing Holep surgery for prostatic adenoma according to two randomized surgical techniques: conventional surgical procedure of removal of the 3 prostatic lobes versus preservation of the median lobe.

Eligibility Criteria:
Inclusion Criteria:

* Patients aged 40 years and older who have signed their consent to participate in the study
* Patient with preserved cognitive functions
* Patient with BPH characterised by an IPSS score ≥ 12, a Qmax ≤ 15 ml/s and an ultrasound-assessed prostate volume between 40 and 150 cc
* Patient for whom an indication for prostatic resection by HoLEP has been made,
* A patient who is sexually active and willing to maintain sexual activity after surgery
* Patient affiliated to a social security system or beneficiary of such a system

Exclusion Criteria:

* History of prostate surgery or prostate radiotherapy
* Urethral stenosis
* Cancer or a history of cancer
* Patient with a life expectancy of less than 2 years
* Patient refusing partial surgery
* History of vasectomy, erectile dysfunction or ejaculation
* Mental deficiency or any other reason that may hinder the understanding or the strict application of the protocol
* Patient under court protection, guardianship or curatorship
* Patient already included in another therapeutic study protocol or having participated in another trial in the previous three months