cyrilzakka/clinical-trials huggingface dataset:
IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia

A Study of IL3 CAR-T Cell Therapy for Patients With CD123 Positive Relapsed and/or Refractory Acute Myeloid Leukemia.

This is a single arm, open-label, single-center study. This study is indicated for relapsed or refractory CD123+ acute myeloid leukemia. The selections of dose levels and the number of subjects are based on clinical trials of similar foreign products. 36 patients will be enrolled. Primary objective is to explore the safety, main consideration is dose-related safety.

Eligibility Criteria:
Inclusion Criteria:

1. Histologically confirmed diagnosis of CD123+ AML per the US National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines for Acute Myeloid Leukemia (2016.v1);
2. Relapsed or refractory CD123+ AML (meeting one of the following conditions):

   1. CR not achieved after standardized chemotherapy;
   2. CR achieved following the first induction, but CR duration is less than 12 months;
   3. Ineffectively after first or multiple remedial treatments;
   4. 2 or more relapses;
3. The number of primordial cells in bone marrow is \> 5% (by morphology), and/or \> 0.01% (by flowcytometry);
4. Total bilirubin ≤ 51 umol/L, ALT and AST ≤ 3 times of upper limit ofnormal, creatinine ≤ 176.8 umol/L;
5. Echocardiogram shows left ventricular ejection fraction (LVEF) ≥50%;
6. No active infection in the lungs, blood oxygen saturation in indoorair is ≥ 92%;
7. Estimated survival time ≥ 3 months;
8. ECOG performance status 0 to 2;
9. Patients or their legal guardians volunteer to participate in the studyand sign the informed consent.

Exclusion Criteria:

Subjects with any of the following exclusion criteria were not eligible for this trial:

1. History of craniocerebral trauma, conscious disturbance,epilepsy,cerebrovascular ischemia, and cerebrovascular, hemorrhagicdiseases;
2. Electrocardiogram shows prolonged QT interval, severe heart diseasessuch as severe arrhythmia in the past;
3. Pregnant (or lactating) women;
4. Patients with severe active infections (excluding simple urinarytractinfectionand bacterial pharyngitis);
5. Active infection of hepatitis B virus or hepatitis C virus;
6. Concurrent therapy with systemic steroids within 2 weeks prior toscreening, except for the patients recently or currently receiving in haledsteroids;
7. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
8. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
9. Other uncontrolled diseases that were not suitable for this trial;
10. Patients with HIV infection;
11. Any situations that the investigator believes may increase the risk ofpatients or interfere with the results of study.
The Natural History of Small Renal Masses

There is a rising incidence of incidentally detected small renal tumours due to improved imaging techniques. Traditionally, patients diagnosed with these small renal masses undergo surgery and therefore there is limited data about the natural history of these tumours. Several small series have reported that most of these small masses grow slowly and might not require early intervention and that only some masses grow rapidly requiring immediate surgery. Presently, the investigators have not been able to identify prospectively which masses are going to grow slowly. The investigators plan to use computed tomography (CT) and Magnetic Resonance Imaging (MRI) parameters, microsatellite analysis and tissue analysis to determine which masses will behave more aggressively. Additionally, the observations on the natural history of small renal masses need to be validated with a multicentric and systematically followed cohort.

Hypothesis

Since most renal cell carcinomas (RCC's) that are now detected by imaging as small renal masses, grow slowly and remain asymptomatic for years, we hypothesize that:

* Small RCC's that are destined to metastasize do so early or after they reach a larger size
* Delayed surgical treatment of asymptomatic, incidentally detected, small RCC's WILL NOT have a significant impact on overall survival
* The majority of small RCC's MAY NOT need to be treated.
* RCC's that are destined to progress can be identified by abnormal perfusion patterns on imaging and by their cellular and genomic characteristics on needle biopsy.

Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic T1a (\< 4.0 cm) renal mass and unfit for surgery due to advanced age or co-morbidity, OR
* Asymptomatic T1a (\< 4.0 cm) and refusal of surgery
* No evidence of metastatic disease (N0M0)
* Preparedness to comply with a close follow-up protocol
* Informed consent

Exclusion Criteria:

* Life expectancy \< 2 years
* Already being followed for a small renal mass for more than 12 months
* Concurrent systemic therapy for other malignancies
* Known hereditary renal cancer syndromes
Open-label, Dose-finding Study to Determine Antibody Response to G17DT Treatment in Patients With Gastric Cancer.

An open label, dose-finding, schedule-changing, sequential, multiple dose, multi-center study in patients with Stage I-III gastric cancer. The first group of patients received a starting dose of 250 µg at weeks 0, 1, and 3. Thereafter, allocation to treatment with 100 µg or 500 µg was based on antibody response and dose tolerability.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed UICC Stage I, II or III gastric adenocarcinoma. Must have had a macroscopically curative resection for gastric cancer with absence of metastatic disease at the time of entry to the trial
* Male or female and over 18 years of age
* Must have a life expectancy of at least three months
* World Health Organization Performance Status of 0 to 1
* Given written conformed consent

Exclusion Criteria:

* Gastric surgery within four weeks of baseline (week 0) or gastric surgery anticipated in the period of the study
* History of other malignant disease within the previous five years, except non-melanomatous skin cancer or in situ carcinoma of the uterine cervix
* Previous use within the last four weeks, concomitant use or anticipated use in the period of the study, of any anti-cancer therapies
* Concomitant use of immunosuppressants, including systemic (i.e. oral or injected) corticosteroids
* Females who pregnant, planning to become pregnant or lactating
* Taking part in another study involving an investigational or licensed drug or device in the three months preceding enrollment or during this study
* Previously received G17DT treatment
* Haemoglobin (Hb) \< 10.0 g/dL White blood cell count (WBC) \< 4.0 x 10\^9/L Platelets \< 100 x 10\^9/L
Prospective Evaluation of Safety and Efficacy of Two Forms of Corneal Stromal Hydration

The study objective is to compare traditional and Wong methods of wound hydration for wound sealing following cataract surgery.


Eligibility Criteria:
Inclusion Criteria:

* Visually significant cataract requiring surgery

Exclusion Criteria:

* Evidence of Fuch's dystrophy, anterior basement membrane dystrophy, or corneal thinning or scarring
* Any intraoperative complications
* Cataract incision length \< 1 mm
* Pregnancy
NIRS as a Continuous Noninvasive Monitoring System of Liver/Kidney Graft Perfusion

The aim of the investigators work is to describe the agreement between NIRS and ecodoppler, as monitoring systems of liver and kidney graft's perfusion in the immediate postoperative period in pediatric patients.

This is an observational descriptive pilot study to explore the Somanetics INVOS® system performance. In this study the investigators will recruit a convenient number of patients, 15 patients, that will be admitted to our ICU after liver/kidney transplantation, in a 6 month period.

The Primary endpoint will be the correlation between hepatic/renal NIRS measurements and graft's artery resistance indices, as evaluated with ecodoppler.

The Secondary endpoints will be:

* The Correlation between NIRS measurements and biochemical indicators of graft function (NGAL for kidney transplantation and INR, SGOT/SGPT, bilirubin, lactate for liver transplantation)
* The Correlation between NIRS measurements and SvO2 values

Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients admitted to our ICU for postoperative care after liver/kidney transplantation

Exclusion Criteria:

* Obesity (BMI \> 35)
* Presence of a surgical plate over the graft
* Impossibility of probe positioning, because of surgical wound, medication or drainage
* Bilirubin level \> 30 mg/dL
Miglustat / OGT 918 in the Treatment of Cystic Fibrosis

Cystic fibrosis is a genetic disease caused by mutation of the cystic fibrosis transmembrane conductance regulator (CFTR). The purpose of the study is to investigate the effects of miglustat on CFTR function in cystic fibrosis patients.


Eligibility Criteria:
Inclusion Criteria:

* Aged 12 years and older
* Male or female
* Non-pregnant women who are to remain non-pregnant for 3 months after the end of the study: only women who are surgically sterile, who are in the menopause (no menstruation for at least one year) or those of childbearing potential who are using a reliable method of contraception. Reliable methods of contraception for female patients include the following:

  * Barrier type devices (e.g., female condom, diaphragm and contraceptive sponge) used ONLY in combination with a spermicide
  * Intrauterine devices
  * Oral contraceptive agent
  * Depo-Provera™ (medroxyprogesterone acetate)
  * Levonorgestrel implants Abstention, the rhythm method or contraception by the partner alone are NOT reliable methods of contraception.

For children, a reliable method of contraception must be considered, if appropriate.

* Accepting for the duration of the study and for 3 months thereafter to use a condom and not to procreate a child (males only)
* Cystic fibrosis patients homozygous for the ΔF508 mutation as confirmed by genetic test
* Signed informed consent prior to any study-mandated procedure

Exclusion Criteria:

* Any condition prohibiting the correct measurement of the NPD such as upper respiratory tract infection
* Acute upper respiratory tract or pulmonary exacerbation requiring antibiotic intervention within 2 weeks of screening
* Severe renal impairment (creatinine clearance \< 30 ml/min as per Cockroft and Gault)
* Female patients who will not undergo a pregnancy test prior to enrollment in the study
* History of significant lactose intolerance
* History of neuropathy
* History of cataracts or known increased risk of cataract formation
* Presence of clinically significant diarrhea (\>3 liquid stolls per days for \>7 days) without definable cause within 1 month prior to screening
* Any known factor of disease that might interfere with treatment compliance, study conduct or interruption of the results such as drug or alcohol dependence or psychiatric disease
* FEVI \<25% of predicted normal
* Oxygen saturation at rest \<88%
* Active or passive smoking as measured using the Smokelyzer®
* Hypersensitivity to miglustat or any excipients
* Planned treatment or treatment with another investigational drug or therapy (e.g., gene therapy) within 1 month prior to randomization
Pathologist Lung Transplant Study

Using a prospective qualitative approach, explore whether pathologist intervention is feasible as part of multimodal multidisciplinary care model for transplant patients in effecting psychological dimensions such as experience, satisfaction, or patient's understanding of their disease. Additionally, to examine if this intervention improves medication adherence.

Specific Aims 1. Create post-transplant pathologist-led intervention Objective 1a: Recruit 10 patients who have undergone lung transplantation primarily for chronic obstructive pulmonary disease (COPD). Use pathologist to show gross/microscopic explanted organs.

Specific Aim 2. Assess the efficacy of intervention pilot Objective 2a: Immediate (within 1 day after pathologist intervention) phone interview to access patient's reaction, feelings, and experience with intervention and understanding of disease.

Objective 2b: 1 month later, phone interview asking questions related to medication adherence, patient experience with intervention and lung transplant overall, and patient understanding of disease. Results will be compared to first interview.

Objective 2c: Analyze Client Satisfaction Questionnaire (CSQ-8) for quality of life, Basel assessment of adherence to immunosuppressive medications scale (BAASIS) as a self report adherence measure, and conduct a mixed methods/grounded theory analysis of qualitative data (patient experience, disease understanding). This analysis will systematically identify themes, and assign these descriptive words.

Specific Aim 3: Finalize intervention protocol based on pilot testing. Objective 3a. Adjust and refine the content and process of intervention protocol based on findings of pilot study Objective 3b. Final changes will assure readiness for large scale study.

Eligibility Criteria:
Inclusion Criteria:

* Lung transplant patient, transplanted after IRB approval of study -Transplanted primarily for COPD
* English speaking
* within three months of initial transplant (prior to initial discharge)
* \> 18 years old

Exclusion Criteria:

* Transplant indication other than COPD
* \<18 year old
* Non English speaking
Transdermal Nicotine and Melatonin Patches for Postoperative Pain Relief

Sixty female non-smoker patients, aged 18-50 years and ASA I and II undergoing elective laparoscopic cholecystectomy under general anesthesia were included in this randomized controlled double-blind study. Patients were randomly divided into 3 groups 20 each, C group patients received transdermal placebo patch, TDN group (15 mg/16 h) and TDM group (7 mg/8h). Assessment of postoperative pain, sedation, hemodynamic variables such as HR and MAP, postoperative monitoring of arterial SpO2 and side effects (e.g. nausea, vomiting, pruritis, respiratory depression and hemodynamic instability) were done 30 minutes, 1, 2, 6 and 12 hours postoperatively. Postoperative Patient's and Surgeons' satisfaction, Intraoperative bleeding and plasma cortisol (µg / dl) 2 hours postoperatively were also assessed.


Eligibility Criteria:
Inclusion Criteria:

* 60 female patients.
* non-smoker patients.
* aged between 18 and 50 years old.
* ASA physical status I and II.
* 70-90 kg body weight and height 160-180 cm.
* undergoing elective laparoscopic cholecystectomy under general anesthesia.

Exclusion Criteria:

* Patients with impaired kidney or liver functions.
* history of cardiac or central nervous system disease.
* history of smoking.
* history of drug or alcohol abuse.
* history of chronic pain or daily intake of analgesics.
* uncontrolled medical disease (diabetes mellitus and hypertension).
* history of intake of non-steroidal anti-inflammatory drugs or opioids within 24 h before surgery.
* allergy to the used medications.
* coagulation defect.
* local infection at the site of application of transdermal patch.
* patient's refusal.
* duration of surgery more than 120 minutes.
Entacapone Augmentation for Schizophrenia

This study is testing the hypothesis that Entacapone added to ongoing antipsychotic treatment can be beneficial in schizophrenic patients with negative symptoms.


Eligibility Criteria:
Inclusion Criteria:

* predominantly negative symptoms
* stable on ongoing antipsychotic treatment

Exclusion Criteria:

* acute psychotic exacerbation
* suicidal ideation
* uncontrolled systemic disease
Efficacy and Safety Study of Maintenance Treatment With rhTPO in Thrombocytopenic Subjects With ITP

The purpose of this study is to evaluate the efficacy and safety of rhTPO in the maintenance treatment of ITP, to explore the appropriate dosing interval of the maintenance treatment of rhTPO .

The eligible subjects with ITP firstly will receive a pre-treatment of rhTPO 300 IU/Kg once daily up to 14 days. The subjects with two consecutive platelet counts above 50×10\^9/L in the pre-treatment period will begin to receive maintenance treatment of rhTPO 300 IU/Kg for 12 weeks. In the period of maintenance treatment, starting dosing interval of rhTPO is every other day followed by the interval adjustments for keeping platelet counts between 30 ×10\^9/L～100 ×10\^9/L. Subsequently, subjects will stop treatment of rhTPO and be followed up for 4 weeks after maintenance treatment.

Platelet count, bleeding and other symptoms will be evaluated before and after treatment.

Platelet transfusion will be administered to subjects with active bleeding symptoms.

Toxicity will be monitored continuously during the entire study. Safety will be assessed by adverse events and laboratory tests.

Eligibility Criteria:
Inclusion Criteria:

* Meeting the diagnostic criteria for immune thrombocytopenia (idiopathic thrombocytopenic purpura).
* Subject with resistance to or relapse after glucocorticoid in the treatment of ITP, not accepts splenectomy, or subject with ineffective or relapse after surgical splenectomy.
* Two consecutive platelet counts (not in the same day) \< 30×10\^9/L.
* Subject is willing and able to provide written informed consent.

Exclusion Criteria:

* Pregnancy or breast feeding.
* Having a medical history of thrombosis.
* Significant abnormal cardio-pulmonary function.
* Abnormal liver and kidney function:

  * a serum creatinine concentration≥ 176.8µmol/l (1.5mg/dl);
  * a serum aminotransferase concentration: more than 2.0 times the upper limit of the normal range.
  * a serum bilirubin concentration: more than 2.0 times the upper limit of the normal range.
* Synchronous tumor.
* Cannot adopt adequate contraceptive precautions during the course of the study.
* Any other treatment drugs for ITP are being taken (except the duration of reducing glucocorticoid dosage as ineffective treatment ).
* Any other situation that is not suitable for participating in the trial according to the judgment of the investigator .
A Thorough QTc Evaluation of the Effect of Semaglutide on Cardiac Repolarisation in Healthy Subjects

This trial is conducted in Europe. The aim of the trial is to evaluate the effect of semaglutide on cardiac repolarisation in healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* BMI (Body Mass Index): 20-30 kg/m\^2
* Body weight: 60-110 kg
* Normal ECG (electrocardiogram)

Exclusion Criteria:

* Female who is pregnant, breast-feeding or intends to become pregnant or is of child-bearing potential and not using an adequate contraceptive method. Women of child-bearing potential must use an effective method of birth control for the duration of the trial and for 5 weeks following the last dose of semaglutide. Only highly effective methods of birth control are accepted (i.e. one that results in less than 1% per year failure rate when used consistently and correctly such as implants, injectables, combined oral contraceptives, some intrauterine devices), or sexual abstinence or vasectomised partner
* Any clinically significant disease history, in the opinion of the investigator, or systemic or organ
* History of seizures, epilepsy, syncope, cardiac arrest, cardiac arrhythmia or Torsades de Pointes, A-V (Atrioventricular) block or structural heart disease
* Family history of long QT (Interval in the ECG: from the start of the QRS complex to the end) syndrome (either objectively diagnosed or suggested by sudden death due to cardiac causes before the age of 50 of a 1st degree relative)
* Family history of sudden cardiac death before the age of 50 of a 1st degree relative
* Use of prescription or non-prescription systemic or topical medicinal products (except routine vitamins, acetylsalicylic acid, paracetamol and contraceptives) within 3 weeks (or within 5 halflives of the medicinal product, whichever is longest) prior to the first dosing of semaglutide
* Smoking, drug or alcohol abuse
The Influence of Education During Waiting Time of Vaccination on the Knowledge Towards COVID-19 Among Chinese Residents

Coronavirus disease 2019 (COVID-19) is a respiratory disease caused by a novel coronavirus, which has developed the global pandemic situation. The promotion of vaccination is an effective strategy to control the epidemic. A total of 19,5738,000 doses of COVID-19 vaccines have been reported in China until August 24th, 2021. During widespread vaccination, the education in COVID-19 prevention and vaccination for residents are also crucial. To figure out the influence of education during waiting time of vaccination, we have designed a randomized controlled trial and planned to distribute leaflets and questionnaires to the residents of Xidian (a town in Ninghai, Zhejiang). This study is of great significance for the prevention of COVID-19 pandemic.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18;
2. Residents who are vaccinated with COVID-19 vaccines at Xidian Passenger Station from August 18th to September 20th, 2021;
3. Able to understand the content of leaflets and questionnaires, and willing to participate in the study.

Exclusion Criteria:

1. Residents who are unable to get vaccinated with COVID-19 vaccines;
2. Unable to understand the content of leaflets and questionnaires, or unwilling to participate in the study;
3. Unreturned or incomplete questionnaires.
Wireless Assessment of Respiratory and Circulatory Distress in Chronic Obstructive Pulmonary Disease - Validation Study

For patients admitted to the medical ward, it is often difficult to predict if their clinical condition will deteriorate, however subtle changes in vital signs are usually present 8 to 24 hours before a life-threatening event such as respiratory failure leading to ICU admission, or unanticipated cardiac arrest. Such adverse trends in clinical observations can be missed, misinterpreted or not appreciated as urgent. New continuous and wearable 27/7 clinical vital parameter monitoring systems offer a unique possibility to identify clinical deterioration before patients condition progress beyond the point-of-no-return, where adverse events are inevitable. As part of the WARD-COPD project, this validation study aim to assess the accuracy of physiologic parameters derived from standard and wireless patient monitors


Eligibility Criteria:
Inclusion Criteria:

- Adult patients admitted with AECOPD

Exclusion Criteria:

* Patient expected not to cooperate
* Patient allergic to plaster, plastic or silicone
* Patients with pacemaker or implantable cardioverter-defibrillator (ICD) unit