cyrilzakka/clinical-trials huggingface dataset:
Circulating Lymphatic Progenitor Cell and Lymph Node Metastasis

Correlation of circulating lymphatic endothelial progenitor cells with lymph node metastasis

Correlation of circulating lymphatic endothelial progenitor cells with lymph node metastasis in ovarian cancer patients

Eligibility Criteria:
Inclusion Criteria:

* ovarian cancer patients diagnosed by pathologic examination

Exclusion Criteria:

* other malignant disease inflammatory disease untreated diabetic and hypertension chronic renal failure rheumatoid arthritis
Protective Effect of Angong Niuhuang Against Negative Inflammatory Response and Neurologic Dysfunction After Cardiovascular Surgery

Neurologic Dysfunction is one of the main factors contributing to poor outcomes in cardiac surgery patients, except for heart failure. Atherosclerosis of the aorta, a history of cerebral infarction, and cervical artery disease are common clinical risk factors for cerebral neurological dysfunction after cardiac surgery. Results of preclinical studies suggested that Angong Niuhuang Pills (ANPs), a traditional Chinese patent medicine, including realgar, cinnabaris, Bovis Calculus, artificial Moschus, and powdered buffalo horn extract, decreased infarct volume and cerebral edema, and presented anti- atherosclerosis and cardio-protective effects in clinical and preclinical studies. The PANDA X trial is designed as a pilot study to explore the safety and efficacy of ANP in patients with moderate-to-severe neurologic dysfunction after cardiovascular surgery.


Eligibility Criteria:
Inclusion Criteria:

* (1) an age \> 18 years,
* (2) underwent cardiovascular surgery,
* (3) diagnosis of acute neurologic dysfunction, including but not limited acute cerebral infarction of the internal carotid artery system,
* (4) a National Institutes of Health Stroke Scale (NIHSS) score ranging from 10 to 20,
* (5) a time from symptom onset to randomization within 36 h,
* (6) provision of informed consent.

Exclusion Criteria:

* (1) not suitable for taking ANP after the dialectical process by a traditional Chinese medical doctor,
* (2) received ANP within 1 month before stroke onset,
* (3) liver failure,
* (4) declined to participate in this study.
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma

This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.

This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate the pharmacokinetics(PK), safety and efficacy of relma-cel, monitor the immune response after relma-cel treatment.

Relma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10\^8 CAR+T cells.The indication for this application is R/R LBCL(supplement study) and the recommended dose is 1×10\^8 CAR+T cells.

Eligibility Criteria:
Inclusion Criteria:

1. ≥18 years old;
2. Sign on the informed consent;
3. Subjects must have histologically confirmed Large B-cell Lymphoma;
4. Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy include autologous hematopoietic stem cell transplantation(auto-HSCT);
5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;
6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;
7. Adequate organ function;
8. Adequate vascular access for leukapheresis procedur;
9. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still expresss CD19;
10. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;
11. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.

Exclusion Criteria:

1. Central nervous system(CNS) only involvement by malignancy or primary CNS lymphoma;
2. History of another primary malignancyn that has not been in remission for at least 2 years;
3. Subjects has HBV,HCV,HIV or syphilis nefection at the time of screening;
4. Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;
5. Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;
6. Presence of acute or chronic graft-versus-host disease(GVHD);
7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;
8. Pregnant or nursing woman;
9. Subjects using of any chemotherapy,corticisteriod,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;
10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;
11. Received CAR T-cell or other genetically-modified T-cell therapy previously.
Public's Intended Uptake and Views on Organization of Esophageal Cancer Screening

Rationale: Research on novel methods to screen for esophageal adenocarcinoma (EAC) has expanded. Insight into individuals' drivers and barriers to attend screening is essential to tailor a potential new screening policy to their preferences. Public preferences should also be considered on the organizational level to guarantee client-centered decision-making in the design of the screening process.

Objective: This study will examine Dutch individuals' intended uptake of EAC screening, including factors that predict uptake, and their views on its organization.

Study design: Cross-sectional population-based survey. Study population: Dutch individuals aged 45-75 years. The required sample size is 2088 and 8350 individuals will be invited based on an assumed participation rate of 25%.

Methods: Eligible individuals will be selected from the Dutch population registry (BRP) using simple random sampling. Invitations will be sent by postal mail with participants being directed to a digital survey.

Main study parameters/endpoints: The primary outcome of the study is the intended uptake of EAC screening (strong vs weak). Secondary study endpoints are the perceived need for consultation, perceived need for general education campaigns, acceptability of risk stratification scenarios, and acceptability of using health care resources for EAC screening.

Nature and extent of the burden and risks associated with participation, benefit and group relatedness: Subjects will not directly benefit from participating in this study. Nonetheless, participating in this study is not associated with any healthcare risks and the burden for the subjects is very low. The survey has a low burdensome nature and will take approximately 15 to 20 minutes to complete. All data will be pseudonymized, refusal to fill out the survey or desire to withdraw from the study will not have any consequences for the invited subject.


Eligibility Criteria:
Inclusion Criteria:

* Aged 45 to 75 years

Exclusion Criteria:

* Previous diagnosis of EAC.
* Unable to provide informed consent.
* Unable to fill out the digital survey.
BioGlue as an Adjunct for Structural Repair and Hemostasis in Chinese Acute Type A Aortic Dissections Patients

A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis to traditional surgical repair in Chinese subject with Acute type A aortic dissections.

A multi-center, randomized, controlled clinical trial is designed to investigate the safety and efficacy of BioGlue as an adjunct for structural repair and hemostasis in Chinese subjects with acute type A aortic dissection. The trial consists of three phases:

Phase One - A non-randomized, lead-in phase. During the lead-in phase, the first 2-3 eligible subjects at each center will receive BioGlue in open surgery. These subjects will be evaluated for safety separately from the randomized phase of the trial.

Phase Two - A randomized, controlled phase. Type A aortic dissection subjects will be randomized into TSR group (control group) and surgical repair with BioGlue group (test group) with a ratio of 1:1, so that equal number of subjects in test and control groups can be ensured.

Phase Three - A Follow-up of Late Safety Outcomes of using BioGlue in "The CHINA Trial" . Subjects enrolled in "The CHINA Trial," from both the BioGlue and the control (TSR) group, will be invited to participate. Clinical data evaluating mortality, adverse events, and re-operation rates will be collected from subject's medical charts.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects 18-70 years of age.
* Subject has a confirmed diagnosis of acute type A aortic dissection with subtype A2.
* Subject is willing and able to give written consent for the trial. If the subject is unconscious or under the influence of medications which render him or her unable to give fully informed consent, a guardian may provide informed consent for the subject regarding trial participation.

Exclusion Criteria:

* Subjects with known allergy to albumin, bovine products, or glutaraldehyde.
* Subjects who have been treated with an investigational product who have not completed the entire follow-up period.
* Subjects who do not meet the eligibility criteria, including those who do not wish to participate or give informed consent for trial participation, will not be enrolled into the trial, and will be offered equivalent, non-trial surgical or other treatment, as judged appropriate by the investigator.
* Subjects with previous cardiac and aortic surgery.
* End stage malperfusion syndromes (i.e. end-organ failure such as coma, paraplegia, hemiplegia, intestinal necrosis, or hepatic failure).
* Subjects with Marfan syndrome or other connective tissue disorders.
* Previous chronic dissections resulting from non-cardiac surgery and/or trauma.
* Concomitant surgery of valve replacement (both in screening and intraoperative).
Noninvasive Ventilation and Thoracic-abdominal Kinematics in Heart Failure Patients

Introduction: Noninvasive ventilation (NIV) has been used to minimize such impairment and increasing ventilator reserve in individuals with heart failure. Aim: To analyze thoracoabdominal kinematics (TK) in individuals with HF associated to cardiomegaly after using NIV. Methods: A randomized crossover clinical trial with allocation consisted of two experimental phases: NIV and control, 7 days apart of each other. During NIV phase, 30 minutes of bi-level ventilation was performed. Any type of ventilator support was offered during control phase. Optoeletronic plethismography was performed to asses TK.


Eligibility Criteria:
Inclusion Criteria:

* body mass index (BMI) \<30 kg/m2
* functional class II-III according to the New York Heart Association
* of the echocardiogram últiimos 6 months showing ejection fraction (LVEF) ≤ 45%,
* últiimos echocardiogram of six months showing cardiac hypertrophy (left Ventricular Diastolic Diameter (LVDD)\> 55mm, Diameter Systolic left Ventricular (LVSD)\> 45mm ),
* (optimized from the point of view of drug,
* clinical stability.

Exclusion Criteria:

* unstable angina, myocardial infarction or heart surgery three months before the beginning of the research,
* chronic orthopedic, infectious or metabolic diseases,
* FEV1/FVC \<70% predicted characterizing obstructive respiratory disorder;
* active smokers;
* Limitation on the use of NIV: claustrophobia, inability to remain with their mouths closed, abdominal distention, hemodynamic instability, heart rate (HR) \<60 bpm, recent trauma, nausea and vomiting face.
Effect of an Anterior Chamber Infusion System on Trabeculectomy Outcomes

In the treatment of glaucoma, trabeculectomy surgery provides a drainage system for the eye and allows for the lowering of the pressure inside the eye. The flow through the surgically created fistula determines the intraocular pressure. Titrating suture tightness is important to achieving the desired post-operative intraocular pressure. This process is not straightforward and intraocular pressures are often too high or too low post-operatively.

The use of an anterior chamber infusion system to deliver fluid into the eye during trabeculectomy surgery may be of benefit in this process and may have other benefits as well which may result in better outcomes.

Thus, the hypothesis of this study is that the use of an anterior chamber infusion system improves success of trabeculectomy surgery.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* One of the following diagnoses:

  * primary open angle glaucoma
  * chronic angle closure glaucoma
  * pseudo exfoliation glaucoma
  * pigment dispersion glaucoma

Exclusion Criteria:

* unable to provide consent or return for follow up
Caregiver Burden in Parkinson's Disease

Primary caregivers of patients diagnosed with idiopathic Parkinson's disease will be included in the study. A total of 43 participants will be recruited. At the beginning of the study, demographic data and clinical characteristics of the patients, including disease stage, history of falls, presence of fractures, presence and severity of pain, comorbidities, and medication use, will be recorded.

Subsequently, caregivers' age, gender, occupation, relationship to the patient, caregiving duration, and their own comorbidities will be assessed. Sleep problems will be evaluated using the Insomnia Severity Index (ISI), while symptoms related to depression and anxiety will be assessed with the Hospital Anxiety and Depression Scale (HADS). Caregiver burden will be examined using the Zarit Caregiver Burden Scale.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40-80 years
* Diagnosed with Parkinson's disease, Hoehn and Yahr stage 2-5
* Requires assistance in daily activities
* Informal caregiver providing care (unpaid, typically a family member such as a spouse or child)
* Caregiver has sufficient proficiency in Turkish to understand and respond to the study questions

Exclusion Criteria:

* Presence of any additional neurodegenerative disease other than Parkinson's disease
* Diagnosis of Chronic Obstructive Pulmonary Disease (COPD)
* Advanced heart failure classified as New York Heart Association (NYHA) Class IV (symptoms at rest)
* Active cancer disease
* History of stroke causing limitations in daily life
* Immobility due to reasons other than Parkinson's disease
A Retrospective Study on Laser Treatment of Nevus of Ota in Thai Patients

A retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients

Nevus of Ota is a benign dermal melanocytic nevus found most commonly in Asians. About 50-60% of all cases have the age of onset at birth or within the first year of life, others appear before puberty. It typically presents as a unilateral mottled blue-gray macules and patches distributed along the first and second branches of trigeminal nerve. Due to its marked hyperpigmentation on the face which does not resolved spontaneously, patients may experience psychosocial disturbances and often seek for treatments. Based on selective photothermolysis theory, Q-switched lasers (ruby 694nm, alexandrite 755nm, Nd:YAG 1064nm) have been used for the treatment of nevus of Ota with a success rate of 95% after 6-8 sessions. Reported complications from the lasers are hypopigmentation(15.3%), hyperpigmentation(2.9%), texture changes (2.9%), and scarring (1.9%). Siriraj Skin Laser Center provides laser treatment for nevus of Ota using mainly Q-switched Nd:YAG laser and Picosecond laser. The study of efficacy and complications of Q-switched Nd:YAG and Picosecond laser in the treatment of Nevus of Ota in Thai patients has never been reported. Therefore, we conduct a retrospective study on efficacy and complication of laser treatment (Q-switched Nd:YAG and picosecond laser) of nevus of Ota in Thai patients.

Eligibility Criteria:
Inclusion Criteria:

* Patient with Nevus of Ota
* Complete data between January 2008 - December 2018

Exclusion Criteria:

* Incomplete data
CORIMUNO-ANA: Trial Evaluating Efficacy Of Anakinra In Patients With Covid-19 Infection

The overall objective of the study is to determine the therapeutic effect and tolerance of Anakinra in patients with moderate, severe pneumonia or critical pneumonia associated with Coronavirus disease 2019 (COVID-19). Anakinra (ANA) is a recombinant human decoy IL-1Ra and therefore blocks IL-1α and IL-1β. The study has a cohort multiple Randomized Controlled Trials (cmRCT) design. Randomization will occur prior to offering Anakinra administration to patients enrolled in the COVIMUNO-19 cohort. Anakinra will be administered to consenting adult patients hospitalized with CORVID-19 either diagnosed with moderate or severe pneumonia requiring no mechanical ventilation or critical pneumonia requiring mechanical ventilation. Patients who will chose not to receive Anakinra will receive standard of cares. Outcomes of Anakinra -treated patients will be compared with outcomes of standard of care treated patients as well as outcomes of patients treated with other immune modulators.


Eligibility Criteria:
Inclusion Criteria:

1. Patients included in the CORIMUNO-19 cohort
2. Patients with C-reactive protein level (CRP) \> 25 mg / L the day or the day before the infusion)
3. Patients belonging to one of the 2 following groups:

   * Group 1: patients meeting all of the following criteria: 1) Requiring more than 3L/min of oxygen; 2) WHO progression scale = 5; 3) No NIV or High flow
   * Group 2: patients with respiratory failure AND (requiring mechanical ventilation OR NIV OR High flow), with a WHO progression scale ≥ 6, and no do-not-resuscitate (DNR) order

Exclusion Criteria:

* Patients with exclusion criteria to the CORIMUNO-19 cohort.
* Known hypersensitivity to Anakinra or to any of their excipients.
* Pregnancy
* Current documented bacterial infection.
* Patient with any of following laboratory results out of the ranges detailed below at screening:

  * Absolute neutrophil count (ANC) ≤ 1.0 x 109/L
  * Haemoglobin level: no limitation
  * Platelets (PLT) \< 50 G /L
  * SGOT or SGPT \> 5N
  * Severe renal insufficiency with Glomerular filtration rate \< 30 ml / mn
A Study of SKB264 Versus Investigator's Choice Chemotherapy in Patients With Unresectable Recurrent or Metastatic Triple-Negative Breast Cancer

The aim of the study is to evaluate the efficacy and safety of SKB264 as first-line treatment for patients with unresectable recurrent or metastatic triple-negative breast cancer (TNBC) whose tumors do not express programmed cell death ligand 1 (PD-L1) or in patients with PD-L1 positive tumors who received prior anti-programmed cell death 1 (PD-1)/PD-L1 inhibitor in early setting

This is a randomized, open-label, multicenter, Phase 3 study to evaluate the efficacy and safety of SKB264 versus investigator's choice chemotherapy as first-line treatment for patients with unresectable recurrent or metastatic TNBC whose tumors do not express PD-L1 or in patients with PD-L1 positive tumors who received prior anti-PD-1/PD-L1 inhibitor in early setting.

Eligibility Criteria:
Key Inclusion Criteria:

1. Histologically and/or cytologically confirmed TNBC.
2. De novo metastatic or relapsed ≥ 6 months post completion of treatment with curative intent.
3. No prior systemic anti-cancer therapy for unresectable recurrent or metastatic disease.
4. Participants whose tumours are PD-L1-negative, or participants whose tumors are PD-L1 positive and have relapsed after prior anti-PD-1/PD-L1 inhibitor for early-stage disease.
5. At least one measurable lesion per RECIST v1.1.
6. Eastern Cooperative Oncology Group (ECOG) performance status of 0 to 1 with no worsening within 2 weeks prior to randomization.
7. A life expectancy of at least 3 months.
8. Eligible for the chemotherapy options listed as investigator's choice chemotherapy (paclitaxel, nab-paclitaxel, capecitabine, eribulin, or carboplatin) as assessed by the investigator.
9. Adequate organ and bone marrow function.

Key Exclusion Criteria:

1. Active second malignancy.
2. Uncontrolled or clinical significant cardiovascular disease.
3. History of noninfectious pneumonitis/interstitial lung disease (ILD) that required steroids or has current pneumonitis/ILD.
4. Active infection requiring systemic therapy within 2 weeks of randomization.
5. Active hepatitis B or hepatitis C virus infection.
6. Human immunodeficiency virus (HIV) positive or history of acquired immunodeficiency syndrome (AIDS); known active syphilis infection.
7. Known hypersensitivity to SKB264 or its excipients.
8. Previously received TROP2-targeted therapy or topoisomerase 1 inhibitors.
9. Prior treatment with the same investigator's choice chemotherapy (except taxane).
10. Pregnant or lactating women.
Low Dose Albumin Versus Standard Dose Albumin in High Risk Spontaneous Bacterial Peritonitis.

AIM:- A randomized non-inferiority trial comparing low dose albumin versus standard dose albumin in high risk Spontaneous Bacterial Peritonitis.

Methodology In this non-inferior randomized controlled trial one group will receive Low dose albumin: 20% albumin 0.75 g/kg at diagnosis and 0.5 g/kg after 48 hours and other group will receive Standard dose albumin: 20% albumin1.5 g/kg at diagnosis and 1 g/kg after 48 h (duration of infusion 6 hours).

Study population: Patients of age \> 18 years of age with cirrhosis of liver who are admitted in ward/Intensive Care Unit diagnosed with Spontaneous Bacterial Peritonitis.

Study design: Randomized controlled trial Study period: September 2019- September 2020 Sample size: 300 (150 cases in each group) If there is a true difference in favour of the experimental treatment of 5 % then 270 patients are required to be 80% sure that the upper limit of a one sided 95% confidence interval (or equivalently a 90 % two-sided confidence interval) will exclude a difference in favour of the standard group of more than 5 %. And if the investigators consider 10% drop out final sample size is 270+30=300. 150 in each limb. Cases will be randomly allocated in 2 groups by block randomization method with block size taken as 10.

Monitoring and assessment: all the parameters of the objective and also noted any adverse effects.

Adverse Effects: Nausea, Vomiting, Fever with chills, dyspnea Stopping Rule: in the event of any of the adverse effects during therapy.

Expected Outcome of the project:

Proportion of patients having new development or progression of Acute Kidney Injury by day 7


Eligibility Criteria:
Inclusion Criteria:

1. \>18 years of age
2. Cirrhosis with SBP (community acquired, health care associated and nosocomial) and baseline serum bilirubin ≥4 mg/dl and/or SCr ≥ 1 mg/dl.

Exclusion Criteria:

1. Antibiotic treatment within one week before the diagnosis of SBP (except for prophylactic treatment with norfloxacin)
2. Significant cardiac failure, pulmonary disease
3. Known CKD ( Chronic Kidney Disease)or findings suggestive of organic nephropathy (proteinuria, haematuria, or Abnormal findings on renal USG)
4. Hepatocellular carcinoma
5. HIV (Human Immunodeficiency Virus) infection;
6. GI (Gastrointestinal) bleed within 1 month before the study
7. Ileus
8. Grade 3 to 4 hepatic encephalopathy
9. Other types of infection
10. Shock
11. Presence of any potential causes of dehydration (such as diarrhoea or an intense response to diuretic treatment) within one week before the diagnosis of SBP).
12. Baseline serum bilirubin \<4 mg/dl or S. Cr \< 1 mg/dl
13. Serum creatinine level of \> 3.0 mg/dl.