cyrilzakka/clinical-trials huggingface dataset:
Surfactant Replacement Guided by Early Lung Ultrasound Score in Preterm Newborns With Respiratory Distress Syndrome

Lung immaturity is a major issue in neonatal unit.The surfactant administration improves the pulmonary prognosis in premature infants with hyaline membrane disease who escape continuous positive airway pressure (CPAP).

This surfactant had been administered at 5h25min of life in Saint Etienne from 2016 to 2019.

Studies suggest that the earlier the surfactant is administered, the more it can reduce the rate of bronchodysplasia and mortality. And some studies show a pulmonary ultrasound could help to administrate the surfactant earlier This is why a new faster strategy for diagnosing preterms needing surfactant will be usefulness and have been done in Saint-Etienne since 2021 thanks to a ultrasound score (LUS).

This current study analyzes the impact of early Lungs Ultrasounds which use a semi-quantitative assessment : the Lung Ultrasound Score (LUS), in preterms \<33 weeks on the time to surfactant administration.

The current hypothesis is that Lung Ultrasound can increase the number of preterms with surfactant replacement within the first 3 hours of life.

This is a prospective, comparative, observational trial between two different cohorts : the last 6 months of 2019 (without Score LUS) versus the first 6 months of 2021 (with Score LUS).

Eligibility Criteria:
Inclusion Criteria:

* newborns \<33 weeks old
* born at the Saint Etienne University Hospital
* respiratory distress syndrome

Exclusion Criteria:

* chromosomal abnormality,
* multi-polymalformations syndrome,
* congenital pulmonary disease,
* septic shock,
* congenital lung infection,
* meconium inhalation,
* pneumothorax
* conditions requiring surgery in the first week of life.
A Study to Evaluate the Safety, Tolerability, Efficacy, and Drug Levels of CC-97540 in Participants With Relapsing Forms of Multiple Sclerosis, Progressive Forms of Multiple Sclerosis or Refractory Myasthenia Gravis (MG) (Breakfree-2)

The purpose of this study is to evaluate the safety, tolerability, efficacy, and drug levels of CC-97540 in participants with Relapsing Forms of Multiple Sclerosis (RMS), Progressive Forms of Multiple Sclerosis (PMS) or Refractory Myasthenia Gravis (MG).


Eligibility Criteria:
Inclusion Criteria

- Relapsing forms of Multiple Sclerosis (RMS) - Cohort 1.

i) Participants must have an Expanded Disability Status Scale (EDSS) of ≥ 3.0 and ≤ 5.5.

ii) Participants must have a diagnosis of Multiple Sclerosis (MS) with relapsed/refractory MS or conversion to active secondary progressive multiple sclerosis (aSPMS), and worsening of disease within 12 months prior to Screening and while on treatment with a high-efficacy DMT for at least 6 months.

- Progressive forms of MS - Cohort 2.

i) Participants must have an EDSS ≥ 3.0 and ≤ 6.0.

ii) Participants must have a diagnosis of primary progressive multiple sclerosis (PPMS) that is treatment-resistant or diagnosis of inactive secondary progressive multiple sclerosis (iSPMS).

- Myasthenia Gravis - Cohort 3

i)MGFA classification of II-IV at screening

ii) Documentation of autoantibodies against AChR or MuSK (historical or at Screening)

iii) Refractory disease defined as disease activity on at least 2 immunosuppressants, including steroids, NSIs, or biologics.

iv) Has had thymectomy, only if indicated according to current guidelines.

Exclusion Criteria

* Cohorts 1 and 2: Participants that cannot complete the 9-Hole Peg Test (9-HPT) in at least 1 hand in \<240 seconds unless extenuating medical conditions unrelated to MS prohibit this.
* Participants that cannot perform a Timed 25-Foot Walk Test (T25FWT) in \< 150 seconds.
* Presence of other confounding peripheral nervous system disorders or other disorders that may impact muscle strength (eg, myositis) or cause weakness, stroke, chronic inflammatory demyelinating polyradiculoneuropathy, Lambert-Eaton myasthenic syndrome.
* Other protocol-defined Inclusion/Exclusion criteria apply.
Endoscopic Cryoablation Combined With PD-1 in Advanced Gastric Cancer

To clarify the efficacy and safety of endoscopic cryoablation combined with PD-1 monoclonal antibody treatment regimen in advanced gastric cancer.

This study is a single-center, single-arm, self-controlled, experimental, non-randomized exploratory clinical trial, aiming to enroll 15 patients with advanced gastric cancer. Each enrolled patient will be assigned a case number. This case number, along with the patient's name initials, will be recorded on every page of the case report form (CRF). Enrolled patients will receive local gastric ECAT (endoscopic cryoballoon ablation treatment) combined with PD-1 monoclonal antibody therapy for the evaluation of efficacy and safety, as well as immunological assessments of peripheral circulation and local tumor tissue. Patients will be followed during the treatment period and for six months after treatment termination for study observation.

Eligibility Criteria:
Inclusion Criteria:

1. Patients diagnosed with advanced gastric cancer (stage IV in AJCC 8th edition staging, including locally progressive gastric cancer with unresectable factors (IVa) and gastric cancer with distant metastases (IVb); Bowman's staging type I, II, and III), who are unable to be surgically resected or do not tolerate surgical resection, and who have undergone progression after 1-2 lines of conventional chemotherapy;
2. Age greater than 18 years and less than 80 years;
3. WHO pathology type: adenocarcinoma, neuroendocrine tumor;
4. Expected survival greater than 3 months and controllable distant metastases as judged by the physician;
5. Important organ functions must be met: ① Liver function: ALT and AST ≤ 2.5 times the positive range, total bilirubin ≤ 2.0mg/dL; ② Renal function: creatinine clearance ≥ 40mL/min calculated using the EPI formula;
6. Blood routine: Hgb≥70g/L,ANC≥1.5×109/L,PLT≥80×109/L;
7. Coagulation function: PT and APPT \<2 times the normal value;
8. Pregnancy test must be negative in women of childbearing age;
9. ECOG score ≤2;
10. Signed informed consent.

Exclusion Criteria:

1. Pregnant or breastfeeding women, or women with pregnancy plans within six months;
2. Infectious diseases (e.g. AIDS, syphilis, active tuberculosis);
3. Patients with active hepatitis B or C infection;
4. Combination of other primary malignant tumors;
5. Patients who have participated in a clinical trial within one month;
6. Patients taking antiplatelet or anticoagulant drugs within the last week;
7. Patients with gastric cancer combined with active bleeding;
8. Large amount of ascites (ascites ≥3000ml);
9. Cardia obstruction or pyloric obstruction;
10. patients with combined active infection or autoimmune disease;
11. Those who the doctor thinks there are other reasons not to be included in the treatment.
A Study to Evaluate the Safety and Immunogenicity of EV71 Vaccine

This study is aims to evaluate the safety, reactogenicity and immunogenicity of EV71 vaccine at a 0.25ml or 0.5ml dose in health volunteers

This is a phase I, prospective, randomized, open-label, two-center study. A total 60 healthy volunteers will be screened for baseline characteristic inclusion/exclusion criteria after providing a written informed consent. Eligible subjects will be recruited and equally randomized to either receive 2 doses of EV71 vaccine 0.25ml or 0.5ml. All subjects should be followed till Day 210.

Eligibility Criteria:
Inclusion Criteria:

* Subject who is free of obvious health problems
* Able and willing to comply with the study procedure adn give written informed consent

Exclusion Criteria:

* Female who is pregnant/lactating or planning to be pregnant
* Body mass index(BMI) \> 35
* Oral temperature \> 37.5 Celsius at the time of planned vaccination
* Subject with any abnormal laboratory results at screening
* With a history of herpangina, hand-foot-mouth disease, acute hemorrhagic conjunctivitis or acute gastrointestinal illness associated with enterovirus infection in the past 3 months
* Has been diagnosed with neurological, pulmonary, cardiovascular, hematological, hepatic or renal disorder
* With a history of hypersensitivity to vaccine or allergic disease
* Use of any investigational/non-registered product within 30 days prior to vaccination
* Use of immunoglobulins or any blood products within 3 months prior to vaccination
* Chronic administration of immunosuppressants or other immunomodulators within 5 months prior to vaccination
Efficacy and Safety of Metoprolol Tartrate Tablets Combined With Chinese Traditional Medicine on Premature Ventricular Complex.

Objective: investigators investigated the effects of metoprolol tartrate plus Tongmai Yangxin Pill on premature ventricular complexes and cardiac function in patients with premature ventricular complex.

Methods: In total, 584 participants with premature ventricular complex will be randomly assigned (at a 1:1 ratio) into two groups: study group (metoprolol tartrate \[25 mg twice per day, orally\] plus Tongmai Yangxin Pill \[40 pills twice per day, orally\]) and control group (metoprolol tartrate \[25 mg twice per day, orally\] plus placebo \[40 simulated pills twice per day, orally\]). The total treatment period is 8 weeks.

Efficacy endpoints and safety assessment:

Primary efficacy endpoints are as follows: change in 24-h number of PVCs after treatment and effective rate of 24-h number of PVCs after treatment. Secondary efficacy endpoints are as follows: change in New York Heart Association classification; total effective rate of comprehensive effect; change in high-sensitivity C-reactive protein level; and change in echocardiography parameters (i.e., left ventricular ejection fraction, left ventricular end diastolic dimension, E/A, cardiac index, cardiac output, and stroke volume).


Eligibility Criteria:
Inclusion Criteria:

* Lown PVC grade, II-IVA;
* in patients with coronary heart disease and comorbid PVC or non-organic heart disease, the PVC frequency was 3000-30000 times/24 h;
* New York Heart Association grade, I or II;
* ejection fraction, ≥45%;
* written informed consent to participate in the trial.

Exclusion Criteria:

* presence of bradyarrhythmia (\<50 beats/min), including sinus syndrome and atrioventricular block (second or third degree atrioventricular block);
* presence of persistent ventricular tachycardia, non-persistent ventricular tachycardia, and/or persistent atrial fibrillation;
* presence of severe PVC requiring treatment with other antiarrhythmic drugs; -presence of drug-induced, electrolyte-induced, or acid-base-induced arrhythmia;
* presence of uncontrolled or severe hypertension (e.g., grade ≥3 hypertension);
* presence of uncontrolled diabetes; presence of alanine aminotransferase or aspartate aminotransferase level ≥1.5-fold above the upper limit of normal, urea nitrogen level ≥1.2-fold above the upper limit of normal, and/or blood creatinine above the upper limit of normal;
* presence of severe respiratory dysfunction or asthma;
* presence of primary hematopoietic diseases, other systemic diseases (e.g., hyperthyroidism), poor peripheral circulation perfusion, severe peripheral vascular diseases, and/or PVC with unknown etiology;
* presence of allergic constitution, mental disorder, alcoholism, and/or smoking habit;
* pregnancy or lactation;
* ongoing β-blocker treatment or contraindications to β-blocker treatment; -participation in other clinical trials within the prior 3 months;
* and other reasons for lack of suitability to participate in this study, as determined by the investigators.
Autonomic Effects of Stimulation in SCI

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment.

This study aims to determine the effects of transcutaneous spinal cord stimulation to increase blood pressure and use that device to increase exercise endurance time and heart rate recovery during arm cycle ergometry. In addition, the investigators will see if the stimulation helps regulate body temperature when in a cool environment. The study will consist of 7 visits, that will be between 3-4 hours in duration, separated by no less than 3 days. Visit 1 will consist of determining baseline autonomic function and screening visit. The participant will undergo a sit up set to determine hypotension and orthostatic hypotension and complete a couple surveys. Visits 2 and 3 will determine which site the stimulation parameters should be on the spine, either T7-T8 or T11-12. The site that increases seated systolic blood pressure will be used for the rest of the study. Visits 4 and 5 will consists of putting the electrode at the optimal spot on the spine and completing a submaximal arm ergometry exercise and the other visit will be a sham visit. Visits 6 and 7 will consist of assessing core temperature when in a cool environment with the stimulator on and off.

Eligibility Criteria:
Inclusion Criteria:

* injury more than 1 year ago, non-ambulatory
* level of lesion C3-T1, AIS A or B
* stable prescription medication regimen for at least 30 days
* must be able to commit to study requirements of 7 visits within a 60-day period

Exclusion Criteria:

* extensive history of seizures
* ventilator dependence or patent tracheostomy site
* history of neurologic disorder other than SCI
* history of moderate or severe head trauma
* contraindications to spine stimulation
* significant cardiovascular disease
* active psychological disorder
* recent history (within 3 months) of substance abuse
* open skin lesions over spine at levels targeted for stimulation (T7/8, T11/12) and pregnancy
Comparative Effectiveness of Pregnancy Failure Management Regimens

The purpose of the study is to compare the effectiveness of combination treatment (mifepristone premedication plus single-dose misoprostol) to single-dose misoprostol (standard of care) for the management of early pregnancy failure.


Eligibility Criteria:
Inclusion Criteria:

* between 5 and 12 completed weeks gestation
* 18 years or older
* hemodynamically stable
* confirmed diagnosis of intrauterine embryonic/fetal demise or anembryonic gestation (ultrasound examination demonstrates a fetal pole without cardiac activity measuring between 5.3 and 40 mm or an abnormal growth pattern diagnostic of early pregnancy failure)
* willing and able to give informed consent

Exclusion Criteria:

* diagnosis of incomplete or inevitable abortion (absent gestational sac and/or active bleeding, open cervical os)
* contraindication to mifepristone (chronic corticosteroid administration, adrenal disease)
* contraindication to misoprostol (glaucoma, mitral stenosis, sickle cell anemia, or known allergy to prostaglandin)
* cardiovascular disease (angina, valvular disease, arrhythmia, or cardiac failure)
* most recent hemoglobin \<9.5 g/dL
* diagnosis of porphyria
* known clotting defect or receiving anticoagulants
* pregnancy with an intrauterine device (IUD) in place
* breastfeeding during the first 7 days of study participation
* unwilling to comply with the study protocol and visit schedule
* any evidence of viable pregnancy
* possibility of ectopic pregnancy
* known or suspected pelvic infection
* concurrent participation in any other interventional trial
Risk of Acute Kidney Injury in Living Liver Donor Surgery

Acute kidney injury (AKI) is one of the most common complication after restricted fluid therapy for major surgery. The aim of this study is to evaluate the incidence of AKI as defined by Kidney Disease Improving Global Outcomes (KDIGO) criteria in living liver donor hepatectomy in which applied intraoperative protocolized fluid restriction targeting a low central venous pressure (CVP) level and high pulse pressure variation (PPV) / systolic pressure variation (SPV).

Operative blood loss and need for transfusion are risk factors associated with mortality after partial hepatectomy. The low central venous pressure (CVP) anesthetic technique has been strongly advocated to minimize hepatic venous bleeding during hepatectomy. Low CVP technique for living donor hepatectomy may not be advantageous regarding the safety of healthy living donors. Safer, simpler, and more useful fluid management methods are, therefore, required to reduce blood loss and subsequent morbidity during living donor hepatectomy. Pulse pressure variation (PPV) and systolic pressure variation (SPV) are the dynamic parameters of hemodynamic used to access the volume status and fluid responsiveness in mechanically ventilated patients.

Based only on the serum creatinine increase, AKI occurs in 5-15% of hepatectomy patients.In this study, we aimed to evaluate the incidence of AKI based on the change of serum creatinine levels in living liver donor hepatectomy regarding intraoperative fluid restriction targeting low CVP levels and high PPV and SPV depending on our protocolized fluid management.

130 living liver donors were admitted for a retrospective observational study. The low central venous pressure (\<5 mmHg) and high pulse pressure variation (PPV\<20%) / systolic pressure variation (SPV\<15%) were applied to reduce intraoperative blood loss as fluid management until the end of the hepatic parenchymal division. AKI was defined using the KDIGO criteria according to the serum creatinine. The SPSS 11.5 program was used for statistical analysis.

Eligibility Criteria:
Inclusion Criteria:

* patients who underwent living liver donor hepatectomy

Exclusion Criteria:

-
Long Term Nebulised Gentamicin in Patients With Bronchiectasis

The hypothesis of this randomized placebo controlled trial is that targeted nebulized gentamicin to the airways will reduce bacterial burden and limit neutrophil airways inflammation. If given long term this will improve symptoms, pulmonary physiology, exercise capacity and health related quality of life with a reduction in exacerbation frequency and health care utilization.


Eligibility Criteria:
Inclusion Criteria:

* Bronchiectasis confirmed by HRCT of the chest
* Clinically stable (not requiring antibiotics for at least 4 weeks preceding the study start date)
* Aged 18-70
* Chronic sputum production \> 5 mls for the majority of days in 3 months before enrolment
* Chronically colonized (on at least 2 occasions in the preceding 12 months) whilst clinically stable
* At least two exacerbations in the past year
* Patients able to tolerate a nebulized gentamicin challenge
* FEV1 \> 30% predicted
* Smoking \< 20 pack year history and ex-smokers \>1 year.

Exclusion Criteria:

* Cystic fibrosis
* Emphysema on HRCT chest
* Thoracic surgery within the past 1 year
* Allergic bronchopulmonary aspergillosis
* Poorly controlled asthma ( \> 20% diurnal variation in peak expiratory flows despite treatment)
* Unstable angina or uncontrolled congestive cardiac failure
* Active malignancy
* Pregnancy or breast feeding
* Creatinine clearance \< 30 mls/minute
* Vestibular instability
* Previous documented intolerance to aminoglycosides
Preloading Magnesium Attenuate Cisplatin-induced Nephrotoxicity

The purpose of this study is to determine whether magnesium preloading reduce incident of cisplatin induced acute kidney injury in head and neck cancer who receiving low dose cisplatin (40 mg/m2 weekly for 7 weeks).

Randomized controlled trial comparing efficacy of magnesium preloading versus normal saline for prevention of acute and chronic nephrotoxicity of cisplatin.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Eastern Cooperative Oncology Group score 0-2
* First Diagnosed Head and neck cancer and plan for treatment with cisplatin
* Serum creatinine ≤1.5 mg/dl or eGFR≥60(ml/min/1.73 m2)

Exclusion Criteria:

* Prior treatment with cisplatin before randomization
* Uncontrolled concurrent disease
* Pregnancy
Clevidipine in the Treatment of Patients With Severe Hypertension (VELOCITY)

The purpose of this study was to determine the safety of clevidipine for treating severely elevated blood pressure, defined as systolic (SBP) \>180 mmHg and/or diastolic blood pressure (DBP) \>115 mmHg assessed on 2 successive occasions 15 minutes apart at baseline, in patients with or without major organ injury, particularly with respect to controlled dose adjustment to desired effect and prolonged continuous infusion. Enrollment of patients into the study was to continue until the target goal of 100 patients with at least 18 hours of continuous clevidipine treatment, including a minimum of 50 patients with acute or chronic end-organ injury, was met.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Systolic blood pressure \>180 mmHg and/or diastolic blood pressure \>115 mmHg assessed on two successive occasions, 15 minutes apart at baseline
* Written informed consent

Exclusion Criteria:

* SBP ≤180 mmHg and/or DBP ≤115 mmHg
* Expectation that the patient will not tolerate intravenous antihypertensive therapy for at least 18 hours
* Known or suspected aortic dissection
* Administration of an agent for treating hypertension within 2 hours of clevidipine administration
* Severe hypertension known to be precipitated by use of, or withdrawal from, alcohol or illicit drugs, or intentional overdose of illicit or prescription drugs
* Positive pregnancy test
* Intolerance to calcium channel blockers
* Allergy to soybean oil or egg lecithin
* Known liver failure or cirrhosis
* Participation in clinical research studies of other investigational drugs or devices within 30 days of enrollment
Study to Determine the Utility of FES-PET in the Prediction of Response to Fulvestrant in Women With Estrogen Positive Metastatic Breast Cancer

Effects of fulvestrant on the ERs may be evaluable by molecular imaging using positron emission tomography with the ER-specific FES tracer. In this study we will determine the utility of FES-PET in the prediction of response to fulvestrant 500 mg in women with estrogen positive metastatic breast cancer

More than 70% of patients with metastatic breast cancer present with hormone receptor positive disease and for whom hormonal therapy is the preferred treatment approach. First-line treatment recommendations for women with hormone receptor positive locally advanced or metastatic disease includes a generation aromatase inhibitors or tamoxifen. Fulvestrant, a 17β-estradiol analog, is an antiestrogen that suppresses estrogen signaling by binding to ER and inducing oestrogen receptor degradation and has estrogen antagonistic activity but no estrogen agonistic effect. Fulvestrant has been shown to have superiority over other endocrine therapy in a series of randomized controlled trials.

The whole-body imaging of the availability of ER using FES-PET may prove valuable to evaluate the effects of fulvestrant on the ER non-invasively in individual patients. This potentially allows early prediction of therapy efficacy to fulvestrant in women with estrogen positive metastatic breast cancer.

In this pilot-study we will evaluate 35 patients who received fulvestrant as treatment for metastatic breast cancer. All patients will undergo FES-PET/CT at baseline and FES-PET after 28 days. Whenever possible, tumor biopsies will be performed to correlate to FES-PET results.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with a history of histological proven ER-positive primary breast cancer and, whenever available, histological proven ER-positive recurrence.
2. No previous fulvestrant treatment
3. ER-antagonists should be discontinued for 5 weeks prior to FES-PET. The use of aromatase inhibitors is allowed.
4. Age \> 18
5. ECOG 0-2
6. Life expectancy \> 6 months
7. Informed consent obtained
8. Able to comply with the protocol

Exclusion Criteria:

1. Presence of life-threatening visceral metastases
2. Evidence of central nervous system metastases
3. \> 3 lines of endocrine therapy for metastatic disease
4. Isolated liver metastasis (high FES uptake by normal liver)