cyrilzakka/clinical-trials huggingface dataset:
EX-PO Trial : Evaluation of the Occlusion Pressure (PO.1) in Extubation Failure

Measuring bedside occlusion pressure in neurosurgical or surgical critically ill patients could tell us about the patient's respiratory drive, and therefore, tell us whether or not extubation will be successful.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old,
* Hospitalized in surgical or neurosurgical intensive care units
* Patients under mechanical ventilation for more than 48 hours,
* Meeting the criteria for severability (spontaneous ventilation test),
* Free subject, without tutorship or curatorship or subordination,
* Patients benefiting from a Social Security scheme or benefiting through the intermediary of a third party,
* No objection given by the patient and / or relative after clear and fair information about the study.

Exclusion Criteria:

* Tracheostomized patients,
* Persons benefiting from enhanced protection, namely minors, persons deprived of their liberty by a judicial or administrative decision, persons staying in a health or social establishment, adults under legal protection,
* Pregnant and / or lactating women.
A Study of Three Doses of TCH346 in Patients With Early Parkinson's Disease to Evaluate Safety and Efficacy

This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents

This study will investigate the effect of TCH346 compared to placebo in delaying the need for symptomatic treatment with dopaminergic agents

Eligibility Criteria:
Inclusion Criteria:

* Male or female ,aged 30-80 years
* Clinical diagnosis of early stage idiopathic Parkinson's disease
* Experiencing two of the three following signs; bradykinesia, rigidity, and tremor
* Not currently taking any antiparkinson medication

Exclusion Criteria:

* A history of alcohol or drug abuse in the past year
* A diagnosis psychiatric illness
* Patients who currently are taking MAO inhibitors within 30 days of entering the study
* Patients who are hypersensitive to selegiline, MAO-B inhibitors, or tricyclic antidepressants

Additional inclusion/exclusion criteria may apply
Comparison of ACT Between Hemochron Jr and ACT Plus

This study aimed to compare 2 activated clotting time analysers (Hemochron Jr vs. ACT Plus).

Measurement of activated clotting time (ACT) is a standard method for anticoagulation monitoring. Especially in cardiac surgery, heparin is usually used as anticoagulant and protamine is used to reverse anticoagulation effect at the end of surgery. ACT method defines the time until a clot is formed in a test tube after triggering of internal pathway coagulation using blood activating agents (eg. kaolin).

Acute normovolemic hemodilution (ANH) consists of withdrawing patient's blood volume early in the operative period and concurrent infusion of crystalloid or colloid to maintain intravascular volume, and is used in cardiac surgery. ANH is known to affect hemostasis in some studies.

Assuming that accurate monitoring of coagulation therapy is important to prevent both thrombotic and hemorrhagic complications, we compared ACT results from 2 analysers (Hemochron Jr and ACT Plus) in patients undergoing cardiac surgery using ANH.

Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent cardiac surgery with heparin administration.

Exclusion Criteria:

* Preoperative hemoglobin under 11g/dL
* Weight under 40kg
* Preoperative coagulopathy
Effect of SARS-CoV-2 Vaccination in Liver Transplant Recipients

To investigate the variations in the humoral response to vaccines for the prevention of COVID-19 in liver transplant patients based on the type of immunosuppressive therapy adopted (tacrolimus based vs no-tacrolimus based) and immunosuppressive blood levels.


Eligibility Criteria:
Inclusion Criteria:

* Liver transplanted patients \>18 years of age.
* Patients who underwent liver transplantation between 01/2015 to 12/2021.
* Patients who underwent liver transplantation at "Policlinico Tor Vergata, Rome, Italy".
* Patients who have had three doses of a vaccine for the prevention of COVID-19.
* Patients who have had three doses of a SARS-CoV-2 vaccine and who have contracted SARS-CoV-2 infection.

Exclusion Criteria:

* Patients who have more or less than three dose of a vaccine for the prevention of COVID-19
* Patients not vaccinated for prevention of SARS-CoV-2 infection.
* Patients who have had three doses of a vaccine for the prevention of COVID-19 prior to liver transplantation.
Evaluate the Safety and Efficacy of ADGRE2 CAR-T in Patients With R/R AML

This is an open label, phase I study to assess the safety and efficacy of ADGRE2 CAR-T in patients with relapsed and refractory acute myeloid leukemia


Eligibility Criteria:
Inclusion Criteria:

1. All subjects must sign and date the Informed Consent before initiating any study specific procedures or activities;
2. Diagnosed as relapse/refractory (r/r) de novo or secondary acute myeloid leukemia (AML);
3. The expression of ADGRE2 in AML blast is positive ;
4. The patient has recovered from the toxicity of previous treatment;
5. ECOG score ≤ 2 and expected survival period is not less than 3 months;
6. Adequate organ function defined as:

   AST ≤3×ULN; ALT ≤3×ULN; Total bilirubin ≤1.5×ULN; Serum creatinine ≤1.5×ULN, or CCR≥60 mL/min; Hemoglobin ≥60g/L ; Indoor oxygen saturation ≥92%; LVEF≥45%;
7. Pregnancy testing: females of childbearing potential must have a negative serum or urine pregnancy test;
8. From the use of study drug to 2 years after treatment, males and female of childbearing potential must agree to use an effective method of contraception

Exclusion Criteria:

1. Diagnosis of acute promyelocytic leukemia;
2. History or presence of a CNS disorder;
3. HBsAg or HBcAb are positive; HCV 、HIV and Syphilis antibody are positive, CMV DNA in peripheral blood is more than≥500 copies /mL;
4. History of severe hypersensitivity reaction;
5. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, New York Heart Association Class II or greater congestive heart failure, atrial fibrillation, or other clinically significant cardiac disease within 12 months before enrollment;
6. History of organ transplant surgery;
7. Required systemic application of immunosuppressive or other drugs;
8. Auto-SCT within the 3 months before enrollment;
9. Active autoimmune or inflammatory diseases of the nervous system (e.g., Guillain-Barre syndrome (GBS), amyotrophic lateral sclerosis (ALS)) and clinically active cerebrovascular diseases (e.g., cerebral edema, posterior reversible encephalopathy syndrome (PRES));
10. Requirement for urgent therapy due to ongoing or impending oncologic emergency (eg, leukostasis or tumor lysis syndrome (TLS)) ;
11. Presence or suspicion of a fungal, bacterial, viral, or other infection that is uncontrolled or requiring antimicrobials for management;
12. Live vaccine received within the ≤ 4 weeks before enrollment;
13. Persons with serious mental illness;
14. History of major surgical operations four weeks before enrollment;
15. History of alcoholism or substance abuse;
16. Was identified by the investigators as unsuitable to participate in the study
Pharmacokinetics of TD-4208 in Patients With Moderate Hepatic Impairment

This multiple-center, nonrandomized, open label, parallel group, single dose study will be conducted in male and female subjects with normal hepatic function or moderate (Child-Pugh Class B) hepatic impairment to evaluate the effect of hepatic impairment on the pharmacokinetics (PK) of TD-4208.


Eligibility Criteria:
Inclusion Criteria:

* For hepatic impairment group: Subject has moderate hepatic impairment (Child Pugh B)
* For normal hepatic function group: Subject is in good health

Exclusion Criteria:

* Women who are pregnant, lactating, breastfeeding, or planning to become pregnant during the study.
* Subject has received an investigational drug (or medical device) within 30 days
* Subject who, for any reason, is deemed by the investigator to be inappropriate for this study; or has any condition that would confound or interfere with the evaluation of the safety, tolerability, or PK of the investigational drug; or is unable to comply with the study protocol.
FT516 in Combination With Monoclonal Antibodies in Advanced Solid Tumors

This is a Phase 1 dose-finding study of FT-516 in combination with monoclonal antibodies in participants with advanced solid tumors. The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.


Eligibility Criteria:
Inclusion Criteria:

* Locally advanced or metastatic solid tumor malignancies that have relapsed or progressed after at least one line of therapy and where the following anti-PD-L1 are approved: avelumab, atezolizumab or durvalumab
* Capable of giving signed informed consent
* Aged ≥ 18 years old
* Willingness to comply with study procedures and duration
* Measurable disease per iRECIST
* Contraceptive use for women and men as defined in the protocol

Exclusion Criteria:

* Pregnant or breast-feeding women
* ECOG performance status ≥ 2
* Evidence of insufficient organ function
* Clinically significant cardiovascular disease
* Receipt of therapy within 2 weeks prior to Day 1 or five half-lives, whichever is shorter or any investigational therapy within 28 days prior to Day 1
* Known active central nervous system (CNS) involvement by malignancy
* Non-malignant CNS disease such as stroke, epilepsy, CNS vasculitis or neurodegenerative disease or receipt of medications for these conditions
* Currently receiving or likely to require immunosuppressive therapy
* Known active infections with Hepatitis B, Hepatitis C or HIV
* Live vaccine within 6 weeks prior to start of lympho-conditioning
* Known allergy to albumin (human) or DMSO
Study to Evaluate the Replacement of Reverse Transcriptase Nucleoside/Nucleotide Inhibitors by Nevirapine in Patients on Triple Treatment With Analogues Only

The purpose of this study is to evaluate the proportion of patients with viral load of HIV-1 \< 50 copies after 48 weeks of follow-up after randomization to change or not to nevirapine.

RTNI (reverse transcriptase nucleoside inhibitors) are a regular part of most antiretroviral combinations. The presence of a smaller or greater degree of cross resistance among all RTNI is increasingly better described and acknowledged, whereby the number of salvage regimens that may be built following the appearance of this resistance to these drugs is by no means unlimited.

This proactive treatment change in patients on RTNI-based regimens while the viral load is still suppressed would avoid the selective replication period under antiviral pressure following the failure of the regimen in which resistance-associated mutations accumulate. This therapeutic approach has demonstrated its effectiveness in clinical practice, albeit not in this scenario.

If we wait until the viral load is detectable there is sufficient evidence that resistance to RTNI will appear and that this resistance will compromise future salvage options.

To intensify with this proactive approach these combinations based on N/NNRTI (nucleotide analog), the NNRTI are an optimal alternative.There is vast experience with NVP in simplification/maintenance trials. In direct comparative simplification studies in patients with virological response, the response rates with NVP or EFV have shown no differences. With a relative risk (RR) of virological failure of 0.54 with regard to the continuation of PI (protease inhibitors), NVP is one of the best simplification treatment options in HIV-1-infected patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients on triple treatment with 3 nucleoside analogues or transcriptase nucleotide inhibitors in virological suppression.
* Age \>= 18 years.
* Confirmed diagnosis of HIV-1 infection.
* Viral load \< 50 copies/ml over the previous six months, including at least two consecutive determinations.
* Value of ALT transaminase £ 2.5 times the normal value of the laboratory of each centre.
* Acceptance and signature of the informed consent form.

Exclusion Criteria:

* Pregnant women or those who intend to become pregnant in the study period.
* Having had an active infection in the previous month.
* Previous exposure to any reverse transcriptase non-nucleoside inhibitor (nevirapine, efavirenz or delavirdine).
* Simultaneous treatment with methadone.
* Patients with serious hepatic dysfunction
Indoor Air Quality and Respiratory Symptoms in Former Smokers

The investigators will conduct a randomized, controlled, double-blind, crossover trial to determine whether the presence of a portable high-efficiency indoor air filter in the bedroom reduces respiratory symptoms in former smokers compared with placebo. The primary outcomes will be change in St. George's Respiratory Questionnaire - COPD (SGRQ-C) score associated with using a portable high-efficiency indoor air filter during the study period. Secondary outcomes of COPD exacerbations and hospitalizations, daily step counts, medication changes, spirometry, and cardiovascular outcomes will also be assessed.

Hypothesis/Research Questions:

This study will determine whether the presence of a portable high-efficiency indoor air filter in the bedroom improves respiratory symptoms (based on St. George's Respiratory Questionnaire - COPD - SGRQ-C score) during a period of high air pollution compared with placebo in former smokers with respiratory symptoms.

The primary outcome will be the change in SGRQ-C score associated with using a portable high-efficiency indoor air filter during the study period.

Secondary outcomes will assess the effect of using a portable high-efficiency indoor air filter on healthcare utilization, other symptom scores, COPD exacerbation frequency, medication use, median daily step counts, inflammatory markers, oxygenation, indoor particulate counts and indoor-outdoor particulate count difference, and pulmonary function tests.

Baseline descriptive statistics will report baseline air filter type, duration of use, and particulate weight prior to study enrollment.

Evaluation of change in symptom scores and other secondary outcomes from baseline to study air filter (Visit 1 vs. Visit 2).

Eligibility Criteria:
Inclusion Criteria:

* history of smoking
* Do not currently smoke and no one currently smokes inside the home
* history of exacerbation or development of respiratory symptoms (e.g.cough, sputum production, chest tightness, exertional dyspnea, etc.) with periods of high outdoor air pollution ("inversions")
* Age 40 or older
* Access to Wi-Fi
* Access to a cell phone, tablet or personal computer

Exclusion Criteria:

* active tobacco use of subject
* active tobacco use in the home
* pre-existing use of a HEPA filter in the subject's bedroom
Pulmonary Vascular Impairment in Chronic Obstructive Pulmonary Disease (COPD) Assessed by MRI

Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent pulmonary disease providing major morbidity and mortality. Bronchial obstruction is the cornerstone in assessment of the disease whereas associated pulmonary vascular disease remains poorly known.

Improving knowledge on pulmonary vascular adaptive skills in COPD patients could allow for better understanding disease exacerbations, evolution towards chronic pulmonary hypertension (PH) and therapeutics to be offered to the patients.

Magnetic resonance imaging (MRI) is an innovative and non-invasive tool capable of pulmonary vascular evaluation. This work aims at identifying pulmonary vascular impairment in COPD patients using functional MRI.

Chronic Obstructive Pulmonary Disease (COPD) is a highly prevalent pulmonary disease providing major morbidity and mortality. Bronchial obstruction is the cornerstone in assessment of the disease whereas associated pulmonary vascular disease remains poorly known.

However, it has been shown that emphysema, frequently observed in COPD, contains major vascular lesions. Alteration of pulmonary vascularisation have been found during exacerbation of the disease.

Moreover, it is well established that such vascular lesions form the substrate for endothelial dysfunction, expressed as an impairment of vascular adaptation during exercise, and evolving towards chronic pulmonary hypertension (PH). Owing to its severe effects on the right-sided heart, it signs a pejorative turn in patients' survival and quality of life.

Finally, COPD patients' phenotypes are very heterogeneous and the clinical response to PH treatments is variable; while some get a benefit, others are counter-indicated due to adverse effects.

Improving knowledge on pulmonary vascular adaptive skills in COPD patients could allow for better understanding disease exacerbations, evolution towards PH and therapeutics to be offered to the patients.

This area of research remains widely unknown because of the lack of simple tools to assess pulmonary vascularisation which could be used in clinical routine. Magnetic resonance imaging (MRI) is an innovative and non-invasive tool capable of pulmonary vascular evaluation. This work aims at identifying pulmonary vascular impairment in COPD patients using functional MRI.

Eligibility Criteria:
Inclusion Criteria:

* Age 40-70
* Diagnosed with COPD
* Emphysema on chest CT
* FEV1 between 35 and 80 %
* Screened for PH by echocardiography

Exclusion Criteria:

* side effect for exercise
* side effect for MRI and contrast agent injection
* Pregnancy or breastfeeding
* Refusing to be informed of the discovery of an anomaly on chest MRI
PD-1 Inhibitor Combined With Neoadjuvant Chemoradiotherapy Plus Surgery for Locally Advanced ESCC (NEOCRTEC2101)

The primary objective is to compare PD-1 inhibitor combined with preoperative chemoradiotherapy followed by surgery versus neo-adjuvant chemoradiotherapy followed by surgery, in terms of the overall survival time (OS) in patients with Stage T1-4aN1-3M0 or T3-4aN0M0 squamous cell esophageal carcinoma.


Eligibility Criteria:
Inclusion Criteria:

1. Histologic diagnosis of squamous cell thoracic esophageal carcinoma of Stage T1-4aN1-3M0 or T3-4aN0M0,which is potentially resectable.
2. Patients must not have received any prior anticancer therapy.
3. More than 6 months of expected survival.
4. Age ranges from 18 to 70 years.
5. Absolute white blood cells count ≥4.0×109/L, neutrophil ≥1.5×109/L, platelets ≥100.0×109/L, hemoglobin ≥90g/L, and normal functions of liver and kidney.
6. WHO PS score 0-1
7. Signed informed consent document on file.

Exclusion Criteria:

1. Patients have received any prior anticancer therapy.
2. Patients are diagnosed or suspected to be allergic to sintilimab,toxal or cisplatin.
3. Patients with concomitant hemorrhagic disease.
4. Patients who cannot tolerate surgery.
5. Pregnant or breast feeding.
6. Patients without informed consent because of psychological, family, social or any other factors.
7. Patients with concomitant peripheral neuropathy, whose CTC status is 2 or even more.
8. Patients with malignant tumors other than esophageal cancer,except for non-melanoma skin cancer, in situ cervical cancer, or cured early prostate cancer.
9. Patients with history of diabetes over 10 years and unsatisfactory glycemic control.
10. Patients with severe heart,lung,liver,renal dysfunction, hematopoietic system diseases, immune system diseases, cachexia or other diseases that lead to intolerance of chemoradiotherapy or surgery.
11. Patients with history of autoimmune diseases, immunodeficiency, or organ and allogeneic bone marrow transplantation.
12. Patients with history of interstitial lung disease or noninfectious pneumonia.
13. Patients with active pulmonary tuberculosis infection, or a history of active pulmonary tuberculosis infection within one year before enrollment, or a history of active pulmonary tuberculosis infection more than one year ago without regular treatment.
14. Patients with active hepatitis B ( HBV DNA ≥ 2000 IU / mL or 104 copies / mL ) or hepatitis C ( HCV antibody positive ).
Bromfenac 0.09% vs Ketorolac 0.4% for Cyclosporine Induction Phase

To compare bromfenac 0.09% and ketorolac 0.4% when used concomitantly with cyclosporine ophthalmic emulsion 0.05% in improving patient comfort during the induction phase of treatment for chronic dry eye disease


Eligibility Criteria:
Inclusion Criteria:

* Must be in general good health
* Diagnosis of moderate to severe dry eye syndrome

Exclusion Criteria:

* Patients who are unlikely to respond to cyclosporine ophthalmic emulsion therapy
* Patients who are pregnant or nursing females
* Unwilling to discontinue use of contact lenses during the run-in and duration of the study
* Presence or history of any systemic or ocular disorder or condition that could possibly interfere with the interpretation of the study results in the study eye
* Previous treatment failure on CSA 0.05% (Restasis)
* Known hypersensitivity to any component of the study or procedural medications
* Participation in any other clinical trial within 30 days prior to screening
* Known contraindication to any study medication or any of their components.
* Should not be taking any oral anti-histamines, beta blockers or diuretics.