cyrilzakka/clinical-trials huggingface dataset:
Early Spontaneous Breathing in Acute Respiratory Distress Syndrome

The care of acute respiratory distress syndrome (ARDS) has been significantly improved by learning from experimental and physiological research works and by a series of randomized controlled trials. The mortality of this syndrome remains however high. Numerous experimental and clinical works demonstrated that a ventilatory mode authorizing the patient to make, from the acute phase, spontaneous breathing cycles superimposed on assistance delivered by the ventilator (BIPAP-APRV mode) allowed to improve gas exchanges and hemodynamic tolerance of the ventilation while reducing the need for sedative drugs. This ventilatory mode could also reduce the risk of diaphragmatic dysfunction induced by ventilation. Consequently, our hypothesis is that this ventilatory mode could allow a reduction of mortality in ARDS patients.

The aim of this multicenter, prospective, randomized, controlled, open study is to compare the effects of two ventilatory strategies on the mortality of ARDS patients and placed under mechanical ventilation.


Eligibility Criteria:
Inclusion Criteria:

* Within 1 week of a known clinical insult or new or worsening respiratory symptoms
* Intubation and mechanical ventilation
* Bilateral opacities - not fully explained by effusions, lobar/lung collapse, or nodules lung
* Report PaO2 / FiO2 ≤ 200 mmHg with a PEP of at least 5 cmH2O
* Respiratory failure not fully explained by cardiac failure or fluid overload
* Criteria 1, 2 and 3 presents jointly for less than 48 hours
* Consent to participate obtained either from the patient himself or from a relative.

Exclusion Criteria:

* Age \< 18 years
* Pregnancy
* Predictable duration of the mechanical ventilation on endotracheal tube lower than 48 hours
* Patient being in period of exclusion further to the participation in another biomedical study
* intracranial hypertension (suspected or confirmed)
* known or suspected COPD
* Chronic respiratory failure treated by long-term oxygen and / or long-term respiratory support
* Morbid obesity defined as weight greater than 1 kg / cm
* Sickle Cell Disease
* Marrow recent transplant, post-chemotherapy aplasia
* Widened burns (\> 30% body surface area)
* Severe hepatic cirrhosis (Child-Pugh C)
* Pneumothorax (drained or not)
* Treatment with extracorporeal support (ECMO)
* Decision of active therapeutic limitation
* Unavailability of the model of respirator that must be used in the study
* Failure to obtain a consent by persons authorized to do so.
* Patient under law protection.
* Person non-beneficiary of a social security system
Care Planning for Older Persons With Multiple Conditions: Encouraging a Tailored Approach (COMET): Stage II

The purpose of the proposed project is to pilot-test in the clinic setting a computer-based clinical decision support system (CDSS) designed to optimize medication prescribing for older persons with multiple chronic conditions and polypharmacy.


Eligibility Criteria:
Inclusion Criteria:

* Veterans age 65 years and older.
* Patients should be diagnosed with diabetes and hypertension and be prescribed five or more medications.
* Patients receiving primary care at the West Haven campus of VA Connecticut Healthcare System.

Exclusion Criteria:

* Unable to manage own medications because of cognitive impairment.
* Medications prescribed by physician outside of the VA.
* Severe vision or hearing impairment.
Study of TL117 in Patients With Recurrent or Metastatic Head and Neck Squamous Cell Carcinoma

The purpose of this study is to assess the safety, pharmacokinetic and efficacy of TL117 plus paclitaxel in patients with recurrent or metastatic head and neck cancer.

This is a Phase 1/2 open label, single arm study, and is divided into three phases: the single-agent dose-escalation phase Ia trial, the TL117 plus paclitaxel dose-escalation phase Ib trial, and the open label, multicenter phase 2 trial of TL117 plus paclitaxel.

Adverse events and dose limiting toxicities will be assessed from the first dose of study drug though day 28. When the maximum tolerated dose (MTD) of TL117 plus paclitaxel is determined, additional patients will be treated at the defined RP2D dose until occurrence of unacceptable toxicity, disease progression or withdrawal of consent or death.

Eligibility Criteria:
Inclusion Criteria:

1. 18-70 years old for Phase 1a, 18-75 years old for Phase 1b and 2;
2. Histologically and/or cytologically confirmation of recurrent/metastatic squamous cell carcinoma of the head and neck;
3. At least one evaluable or measurable tumor lesion;
4. Adequate performance status;
5. A minimum life expectancy of \> 3 months;
6. Adequate cardiac, kidney, and liver function;
7. Willingness of all subjects of childbearing potential to use acceptable methods of birth control;

Exclusion Criteria:

1. Any chemotherapy, radiotherapy, targeted therapy, immunotherapy, endocrine therapy and other systematic anti-tumor therapies within 4 weeks prior to the first dose of the study drug (some exceptions apply)
2. Prior or current PI3K inhibitor therapy;
3. Type 1 or type 2 diabetes requiring antihyperglycemic medication;
4. Major organ surgery (excluding needle biopsy) or significant trauma within 4 weeks prior to the first dose, or required elective surgery during the study period;
5. Any unresolved toxicities from prior therapy greater than Grade 1;
6. Inability to swallow, or serious gastrointestinal absorption conditions;
7. History of immunodeficiency;
8. Active central nervous system metastases;
9. Active hepatitis B or C virus infection;
10. Uncontrolled active infection;
11. Serious cardiovascular disease；
12. Clinically uncontrollable effusion in the third space;
13. Known allergy and/or contraindications to paclitaxel;
14. Known alcohol or drug dependence;
15. Mental disorders or poor compliance;
16. Pregnant or lactating women;
Is Synchronization More Effective During Noninvasive Ventilation in Immediately Extubated Preterm Infants?

The purpose of this study is the examination of the hypothesis that synchronized nasal IMV as compared to non-synchronized nasal IMV will decrease breathing effort in preterm infants immediately after extubation when recovering from Respiratory distress syndrome (RDS).

Another objective is to examine the effects for synchronized non-invasive mechanical ventilation on gas exchange and cerebral oxygen saturation.

In this study the investigators plan to test the hypothesis that synchronized nasal IMV (S-NIMV) as compared to non-synchronized nasal IMV (NIMV) will decrease breathing effort in preterm infants immediately after extubation when recovery from RDS, as measured by phasic esophageal pressure deflection.

Furthermore, the investigators plan to evaluate the effects of synchronized NIMV on gas exchange and brain oxygenation, and to evaluate the reliability of a newly developed abdominal pressure sensor device for the S-NIMV mode in a newly designed commercially available ventilator device.

Eligibility Criteria:
Inclusion Criteria:

Preterm infants recovering from respiratory failure with the following criteria were eligible for this study.

* Gestational age \<32 wks, those who are on invasive mechanical ventilation, recovering from RDS, and ready for extubation as judged by the clinical team.
* Informed consent available.

Exclusion Criteria:

• Infants with major congenital anomalies involving the CNS, lung (i.e. lung hypoplasia, active air leaks) or the heart (ASD, VSD allowed), or known neuromuscular disease.
Money or Knowledge? Behavioral Aspects of Malnutrition

Malnutrition accounts for nearly half of child deaths worldwide. Children who are well-nourished are better able to learn in school, grow into more physically capable adults, and require less health care during childhood and adulthood. Moreover, it is difficult to make up for poor childhood nutrition later in life. I present here the proposal for an intervention that builds on a larger study in Ethiopia and will generate insights into the importance of behavioral factors related to persistent malnutrition in low-income settings, allowing for more targeted, cost-effective interventions in the future.

Existing data from the study region, Oromia, Ethiopia, suggest that many mothers know how to correctly respond to a hypothetical situation where a young child exhibits poor growth. On the other hand, however, mothers frequently appear unaware about their own children's growth deficiencies. Together, these facts suggest that false beliefs about the appropriateness of a child's physical size are a more likely contributor to malnutrition, rather than a weak understanding of how to help a malnourished child.

The proposed intervention will provide evidence on the relationship between caregiver beliefs about child nutritional status and the caregiver's behavior, ultimately analyzing how this relationship influences important nutritional choices for young children in a setting with limited resources. The study uses a two-by-two randomized trial; the first treatment is a cash transfer labeled for child food consumption, and the second is the provision of personalized information about the quality of the child's height compared to other children like those of the same age and gender in East Africa. Together the two treatment arms will provide evidence about the relative importance of behavioral versus resource barriers to improved nutrition. Better understanding of the interaction between these key factors is essential in addressing one of the foremost health issues facing developing countries today.


Eligibility Criteria:
Households for this study were selected from among those who were included in any of the three study groups from a larger study and for whom relevant data had been collected.

Inclusion Criteria:

* inclusion in the larger study required the household to have a child who was 6-35 months old for the main study's baseline survey in July-August 2015 (referred to as the index child) and for the household to have land for crop cultivation

Exclusion Criteria:

* Households that did not meet the inclusion restriction or those who did not have anthropometric data collected during the larger study.
Dyslipidemia Study Investigating The Increase In "Good Cholesterol"

An eight week comparison of the investigational drug GW590735, placebo, and the marketed drug fenofibrate intended to increase the levels of "good cholesterol" and decrease levels of "bad cholesterol" in healthy patients with low levels of good cholesterol and high levels of bad cholesterol.

A multi-center, three-staged, randomized, parallel group, sequential, double-blind, fenofibrate-and placebo-controlled dose-response evaluation of the safety, tolerability, and effects on plasma HDLc and TG of eight weeks treatment with 1µg to 20µg daily doses of GW590735 in otherwise healthy subjects with low HDLc, mildly to moderately elevated TG, and normal LDLc

Eligibility Criteria:
Inclusion criteria:

* High-density lipoprotein cholesterol less than or equal to 45 mg/dL.
* Triglycerides greater than or equal to 120 mg/dL and less than or equal to 500 mg/dL.
* Women must be surgically sterile or postmenopausal.

Exclusion criteria:

* Heart disease
* Diabetes
Sphenopalatine Block in Headache in Patients With Non-traumatic Subarachnoid Hemorrhage

Non-traumatic SAH, linked in 85% of cases to the rupture of an intracranial aneurysm, is a serious stroke affecting young people. Half of all survivors suffer cognitive impairment. The presentation is that of a sudden-onset, isolated headache. This population is exposed to headache during hospitalization, which lasts an average of 13 days. This length of hospitalization is due to the fact that these patients must be monitored during the potential vasospasm period that occurs between days 4 and 14 after SAH. The pain associated with SAH is a source of discomfort and increased morphine consumption during the ICU stay, particularly during the first 10 days. Current recommendations call for conventional pain management with a combination of tier 1, 2 and/or 3 analgesics. For headache control, opioids are widely prescribed, sometimes in high doses, with adverse effects, despite efforts to reduce their use. Maximum headache pain scores remain high, indicating inadequate pain management. This highlights the urgent need to study alternative opioid-sparing and analgesia strategies for patients with SAH.

Sphenopalatine block is already used for certain types of facial and cranial pain, and could help save morphine consumption during hospitalization. The sphenopalatine ganglion is a crossroads for parasympathetic, sympathetic and sensory pathways. Recently studied in post-puncture dural breaches with promising results, sphenopalatine ganglion block (SPGN) may appear as an interesting alternative therapy in the treatment of SAH headaches. Other advantages of this block are its simplicity, efficacy and the absence of any noticeable adverse effects at the time it is performed. What's more, it is already used routinely in our department, with rapid and effective action. The hypothesis of the trial would be to reduce morphine consumption by at least 50% for patients benefiting from BGSP, for better neurological monitoring and optimal overall pain management in SAH.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years
* Non-traumatic SAH with or without aneurysm on brain imaging
* WFNS score 1 and 2
* Patient awake and extubated after radiological procedure
* Patient in pain (EN \> 3/10) despite usual level 1 analgesics (Paracetamol + Acupan)
* Affiliated with or benefiting from a social security scheme

Exclusion Criteria:

* Contraindication to sphenopalatine ganglion block (deviated nasal septum, repeated epistaxis, allergy to Lidocaine)
* Patient unable to assess pain by EN
* Persons covered by Articles L1121-5 to L1121-8 of the CSP and Articles 31 to 35 of Regulation 536/2014.
* Participation in other interventional research
* Patient's refusal to participate
* Arteriography more than 48 hours old
* Inaugural headache lasting more than 48 hours
* Presence of an unsecured vascular malformation at high risk of rupture
Clinical Assessment of the Treatment With Cardiac Sympathetic Blockade on Chronic Heart Failure

The purpose of this study is to evaluate the effect of Cardiac Sympathetic Blockade on Mortality, re-hospitalization rate, symptoms, quality of life, exercise tolerance, cardiac structure, systolic function, electrical activities and concentration of B - type natriuretic peptide precursor in patients with Chronic Heart Failure.


Eligibility Criteria:
Inclusion Criteria:

* 20-70 years old
* more than 3 months of chronic heart failure history or clinical symptoms of heart failure last for more than 3 months (including acute episode of chronic heart failure), chronic heart failure diagnostic criteria refer to 2012ESC Guidelines for the diagnosis and treatment of acute and chronic heart failure
* NYHA functional class III-IV, ejection fraction ≤45%
* NT-proBNP\>400ng/L

Exclusion Criteria:

* first episode of acute heart failure
* unrepaired valvular heart disease accompanied with Hemodynamic changes
* hypertrophic cardiomyopathy, pericardial disease, congenital heart disease, severe pulmonary hypertension
* Second-degree type 2 or worse sinoatrial or atrioventricular block without pacemaker therapy
* right heart failure caused by various diseases, respiratory failure or right heart failure induced by chronic obstructive pulmonary disease
* overt renal decompensation: serum creatinine\>2.1mg/dl(186umol/L)
* severe hepatic dysfunction, transaminase or alkaline phosphatase \> 3 times the upper limit of normal
* Cerebral vascular accident in three months( cerebral infarction, cerebral embolism, cerebral hemorrhage,etc)
* life expectancy shorter than 6 months
* patients with a previous or present history of tumour or precancerous lesions confirmed by pathological examination
* Spine Deformity or skin infection at puncture site
* participate in any clinical drug trials in the three months
* the patients who do not sign the informed consent, unable or unwilling to comply with the requirements of the protocol or unsuitable for the study
Evaluating the Effects of Propofol vs. Dexmedetomidine

The primary purpose of this observational study is to compare what drugs work best in sedating children (\> 3 months to \< 36 months) who need an MRI. This type of research may help clinicians (healthcare providers) learn more about how dexmedetomidine works compared to propofol. The investigators are planning to have 60 children complete the study at Children's Healthcare of Atlanta at Scottish Rite. Half (30) of the patients will be randomized to receive dexmedetomidine and the other half will receive propofol. (Both drugs are licensed and approved for the sedation performed for consented patients.)

There are several different medications commonly being used to facilitate the administration of radiologic procedures on children. Procedures such as Magnetic Resonance Imaging (MRIs) require that the patient remain still for the duration of the test. Propofol has become the drug of choice for many sedation services due to its rapid onset of action, rapid recovery time, ability to achieve sedation reliably and favorable safety profile. Dexmedetomidine, a selective alpha-2- adrenergic agonist, has also gained popularity with sedation services. Its main advantage over propofol is that it has minimal respiratory complications when compared to propofol. The sedative effect from dexmedetomidine preserves a natural sleep pattern and induces cooperative sedation in which patients are easily arousable. In pediatric studies, the most frequent adverse effect have been related to its potential to cause hypotension and bradycardia, which resolve with dose reduction. Additionally, dexmedetomidine does not seem to have as much impairment of cognitive function and has an opioid sparing effect. Dexmedetomidine, however, has a longer onset of action and longer recovery time compared to propofol, which has limited its use with many sedation services.

Eligibility Criteria:
Inclusion Criteria:

1. Patient (or Parent/Guardian) is English speaking
2. Patient is undergoing a scheduled, elective non-contrast MRI of the brain
3. Patient is \> 3 months to \<36 months of age

Exclusion Criteria:

1. Patients undergoing MRI with contrast
2. Patients older than 36 months of age or younger than 3 months of age
3. Patients presenting to Emergency Department (ED) out of screening hours
4. Patients who are not English speaking
5. Patients who have history or record of propofol or dexmedetomidine allergy
6. Patients with known or history of anaphylaxis to eggs, egg products, soybeans, or soy based products; if patient has a history of a hypersensitivity reaction associated with exposure to eggs, egg products, soybeans, or soy based products, approval must be given by the treating attending physician and documented on the patient's medical record.
7. Patients with unstable cardiac or respiratory status as determined by treating attending physician
8. Patients who are receiving digoxin
Combining Myocardial Strain and Cardiac CT to Optimize Left Ventricular Lead Placement in CRT Treatment

For patients with advanced heart failure, Cardiac Resynchronization Therapy (CRT) has been a major improvement. The treatment improves symptoms and prolongs life in selected patients with heart failure. However, with the current selection criteria and methods for implanting the pacemaker, only 60-70% of the patients derive significant benefit from the treatment.

New imaging techniques, including advanced ultrasound and computed tomography, in combination with new versatile multi-pole electrodes, have made an individually tailored therapy possible. Using these techniques in combination, the study will investigate the effect of individually based "optimal" placement of the pacemaker electrodes vs. standard care. The optimal LV electrode position is defined as pacing a viable segment with the latest mechanical delay, targeting a specific segment of the coronary sinus as visualised on cardiac CT. The hypothesis is that this will increase the number of positive responders from 65% to 85%.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic heart failure (New York Heart Association functional class II - IV) despite stabile optimal medical therapy.
* Wide QRS ≥ 120 milliseconds on standard ECG.
* LV systolic dysfunction (EF ≤ 35%).
* Written informed consent.
* Accepted for CRT-P or CRT-D treatment

Exclusion Criteria:

* Life expectancy \< 12 months.
* Recent myocardial infarction (\< 3 months).
* Significant valve disease
* Chronic atrial fibrillation
* Pregnancy
* Severely impaired renal function (estimated glomerular filtration rate (eGFR) \< 30 ml/min)
* Unable to give written informed consent.
Probe Based Confocal Laser Endomicroscopy During Thoracoscopy for Pleural Malignancies Diagnosis.

Probe based confocal laser endomicroscopy (pCLE) is a new optical endoscopic technique, generating fluorescent light emission from the tissue of interest and allowing in vivo live imaging at a cellular level ("optical biopsies"). It was first used in gastroenterology and came later to the light in pulmonary medicine and is still an experimental technique. In gastroenterology, this new investigational technique is used in Barret oesophagus, inflammatory bowel disease, pancreas cystic lesions... Nowadays, there are no data concerning usefulness of endomicroscopy in medical thoracoscopy. During thoracoscopy This new tool could help to target biopsies or help clinicians to do the right diagnosis early, allowing rapid therapeutic intervention (talc pleurodesis for example) . Furthermore, some details can be studied only during live imaging as microorganisms or bloodflows. The investigators performed an endomicroscopy to every patient needing a thoracoscopy (no matter the indication) and who agreed to participate. The pCLE features between malignant and benign pleura were compared in order to find specific criteria for malignant infiltration.


Eligibility Criteria:
Inclusion Criteria:

* Every patient refered for a medical thoracoscopy and willing to participate.

Exclusion Criteria:

* \< 18 ans