cyrilzakka/clinical-trials huggingface dataset:
Bioequivalence of Single Dose Extended Release Naproxen Sodium (660 mg) Tablet Versus Naproxen Sodium (220 mg) Tablet Three Times Daily

Bioequivalence trial in healthy adult subjects to determine the bioavailability of 3 different sustained release formulations of naproxen 660 mg relative to the established commercial Aleve 220 mg tablet.


Eligibility Criteria:
Inclusion Criteria:

* Healthy ambulatory male and female subjects 18 to 55 years of age, inclusive
* Body Mass Index (BMI) of approximately 18.0 to 30.0 kg/m2, and a total body weight \>50 kg (110 lbs)
* Results of screening and clinical laboratory tests are within normal limits or considered not clinically significant by the Principal Investigator or Sponsor
* Female subjects of childbearing potential must be using a medically acceptable form of birth control for at least 1 month prior to screening (3 months on oral contraceptives), e.g., oral or patch contraceptives, intrauterine device, intramuscular injection or double-barrier and have a negative pregnancy test at Screening and on Day 0 of each treatment period. Female subjects of nonchildbearing potential must be amenorrheic for at least 2 years or had a hysterectomy and/or bilateral oophorectomy.
* Provide a personally signed and dated informed consent prior to inclusion in the trial indicating that the subject has been informed of all pertinent aspects of the trial.

Exclusion Criteria:

* History of hypersensitivity to aspirin (ASA), naproxen sodium, or acetaminophen, and similar pharmacological agents or components of the products
* History of gastrointestinal bleeding or perforation, including bleeding related to previous NSAID therapy. Active, or history of recurrent peptic ulcer/hemorrhage (two or more distinct episodes of proven ulceration or bleeding).
* Have taken ASA, ASA-containing products, acetaminophen (acetyl-para-amino-phenol or APAP) or any other NSAID (OTC or prescription) 7 days prior to dosing or during the treatment period, other than study treatment
* Loss of blood in excess of 500 mL within 56 days of the first dose of trial treatment (e.g., donation, plasmapheresis, or injury)
* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing)
* Positive alcohol or drug screen at Screening or on Day 0 of Treatment Periods 1 or 2
* Females who are pregnant or lactating
* Smokers or currently consuming any type of tobacco product(s) including any smoking cessation nicotine-containing product (eg, nicotine patch, nicotine gum).
Inspiratory Muscle Training and Nasal High Flow in Difficult Weaning

The purpose of the present study is to investigate the effectiveness of inspiratory muscle training and nasal high flow oxygen in patients with difficult weaning and high-risk for re-intubation. The hypothesis of the study is that starting inspiratory muscle training once patients are awake and co-operative along with the application of nasal high flow oxygen immediately after extubation will have a beneficial effect in preventive re-intubation in these high-risk patients.

20-30% of intubated patients are difficult to be weaned off the mechanical ventilation and have a prolonged ICU stay. It is well established that prolonged ICU stay is associated with reduced muscle strength, functional ability and quality of life.

Inspiratory muscle training (IMT) via a threshold device has been proposed as an effective exercise for minimizing the detrimental effect of mechanical ventilation in critical ill patients with prolonged weaning. Additionally, Nasal High Flow (NHF) oxygen has been proved to support efficiently either high or low-risk patients after extubation and thus preventing re-intubation.

A randomized intervention study was designed to assess the efficacy of combining IMT and NHF as therapeutic strategies for difficult weaning. Once patients with prognostic factors of difficult weaning are awake and co-operative they will be randomized to one of the two following study groups: 1) IMT and NHF group, 2) IMT and Venturi mask group. IMT will start as soon as the patient wakes up and is cooperative, ventilated with support settings. Each allocated oxygen delivery device will be applied immediately after extubation. IMT intervention will continue until patients' discharge from the ICU.

Eligibility Criteria:
Inclusion Criteria:

* \>65 years,
* BMI\> 35kg/m2,
* weak cough,
* heart (i.e heart failure ) and lung comorbidities (i.e COPD),
* hypercapnia during mechanical ventilation
* \> 72hours on mechanical ventilation
* failed first spontaneous breathing trial

Exclusion Criteria:

* Glasgow Coma scale (GCS)\<13,
* pre-existing neuromuscular disease or deformity of Spinal Cord,
* terminal disease
* hemodynamic instability with \>0.1μg/kg/min noradrenaline
* patients of immediately need of Non-invasive ventilation after extubation
Norepinephrine Weaning Guided by the Hypotension Prediction Index in Vasoplegic Shock After Cardiac Surgery

In postoperative cardiac surgery under extracorporeal circulation, the patient may develop a vasoplegic syndrome, characterized by arterial hypotension (mean arterial pressure (MAP) \< 65 mmHg); a decrease in vascular resistance and a cardiac output that may be normal or increased, and increased postoperative mortality/ International recommendations recommend the prescription of noradrenaline as a first-line treatment to reduce morbidity and mortality. However, excess norepinephrine or duration of exposure is also deleterious. The Acumen IQ device (Edwards Lifesciences) allows the calculation of a predictive index of arterial hypotension episodes (predictive hypotension index, HPI). HPI could improve norepinephrine weaning by preventing episodes of arterial hypotension or detecting preload dependence, thus avoiding the transient increase in norepinephrine during hypotension.

This is a single-center, prospective, open-label, randomized, controlled, 2-group, parallel, intention-to-treat study. The aim was to evaluate the superiority of a new decision algorithm, based on the HPI delivered by the Acumen IQ device, to reduce the duration of norepinephrine administration in post-cardiac surgery vasoplegic shock.

The duration of the interventional protocol is 72 hours. To evaluate the clinical impact of the protocol, the time of the study will be 30 days. Several follow-up visits will be performed (end-of-protocol day, discharge day, and at D30 of inclusion) to collect clinical, biological, and HPI monitoring data.


Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* The patient was hospitalized in the cardiothoracic-vascular and respiratory intensive care unit of Amiens-Picardy University Hospital.
* Patient scheduled for on-pomp cardiac surgery \[coronary artery bypass grafting, valve replacement, ascending aorta replacement, or combined surgery (valve and bypass grafting)\].
* Introduction of norepinephrine post-surgery for the treatment of vasoplegic syndrome.
* On-pomp cardiac surgery in less than 48 hours.
* Hemodynamically stable patient with MAP \> 65 mmHg for more than 4 hours on noradrenaline
* Monitoring of MAP with a radial or femoral arterial catheter
* Social security beneficiary
* Signature of the consent to participate in the study by the patient, preoperatively

Exclusion Criteria:

* Permanent arrhythmia (atrial fibrillation, flutter, or frequent atrial extrasystoles).
* Treatment with dobutamine, epinephrine, or vasopressin analog
* Patients with preoperative chronic end-stage renal failure require postoperative extra-renal purification.
* Pregnant woman
* The patient is dependent on an internal or external pacemaker.
* Hypothermia \< 36°.
* Patient under mechanical circulatory assistance after cardiac surgery.
* Hemorrhagic shock
* Patient under guardianship or curators
N-ACetylcysteine to Reduce Infection and Mortality for Alcoholic Hepatitis

Recent data have suggested that monocyte oxidative burst defect is associated with the development of infection in patients with severe alcoholic hepatitis. One report found reduced 28 day mortality in patients treated with N-acetylcysteine combined with prednisolone when compared to prednisolone alone. The current study seeks to reveal whether the mechanism by which NAC reduces susceptibility to infection is through improvement of phagocyte oxidative burst.

Randomised controlled trial, open label.

Eligibility Criteria:
Inclusion Criteria:

* Aged 18 years or older
* Clinical alcoholic hepatitis:

  * Serum bilirubin \>80umol/L
  * History of alcohol excess (\>80g/day male, \>60g/day female)
  * Less than 4 weeks since admission to hospital
  * Maddrey's discriminant function (DF) \>32
  * Informed consent

Exclusion Criteria:

* Alcohol abstinence of \>6 weeks prior to randomisation
* Duration of jaundice \>3 months
* Other causes of liver disease including:

  * Evidence of viral hepatitis (hepatitis B or C)
  * Biliary obstruction
  * Hepatocellular carcinoma
* Evidence of current malignancy (except non-melanotic skin cancer)
* Previous entry into the study
* Patients with known hypersensitivity or previous reactions to NAC
* Pregnant or lactating women
Eye Patch Therapy for Central Serous Retinopathy (CSR)

First, this study will investigate the viability of 24-hour eye patching as a potential treatment modality for CSR. Second, this study will assess a potential physiologic explanation for CSR, namely if inhibition of photic stimulation of the diseased retina will aid in ameliorating disease severity and disease duration.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 years of age and older
* Both males and females
* Patients diagnosed with active central serous retinopathy
* Patients who are willing to use an eye patch in the affected eye for 24 hours
* Patients who are able to make the follow up appointments as required by the study

Exclusion Criteria:

* Individuals under 18 years of age
* Patients with vision less than 20/40 in the unaffected eye.
* Patients who are not able to undergo mfERG testing in a realiable manner.
A Phase I Clinical Study of SSD8432 in Healthy Adult Subjects

This is a Phase I Clinical Study to Evaluate the Safety, Tolerability, and Pharmacokinetics of SSD8432 in Healthy Adult Subjects

108 healthy adult subjects (including 72 subjects in Part A to C, 16-24 subjects in Part D, and 8-12 subjects in optional Part E), including both males and females, will be enrolled in the phase I study.

This study will include Five parts: SSD8432 single dose and SSD8432 co-administrated with ritonavir (Part A), SSD8432 multiple dose (Part B), SSD8432 co-administrated with ritonavir multiple dose (Part C), SSD8432 co-administered ritonavir single dose in fasting and postprandial states (Part D: assessment of food effects) and optional part (Part E: Assessment of the safety and pharmacokinetics of SSD8432 in white healthy adult subjects)

Eligibility Criteria:
Inclusion Criteria:

* Male subjects' weight ≥ 50 kg, female subjects' weight ≥ 45 kg; body mass index ≥ 19 kg/m2 and ≤ 28 kg/m2.
* Female participants of child-bearing potential must agree to use adequate contraception from screening until 1 months after last dose.

Exclusion Criteria:

* History of any other acute or chronic illness (including cardiovascular, pulmonary, neurological, hepatic, rheumatic, hematological, metabolic or renal disorders), or use of medication that, in the opinion of the Principal Investigator, may not suitable for participating in this study.
* Subjects with a history of hematophobia or trypanophobia and unable to tolerate intravenous indwelling needle blood sampling.
* History of dysphagia or any other gastrointestinal disease possibly affecting drug absorption.
* Take special diet and cannot abide by the provided food and corresponding requirements in this study.
* Subject with a history of clinically significant hypersensitivity reactions to the active substance of SSD8432 or ritonavir or to any other components of drug products.
Assessment of the Optimal Dosing of Piperacillin-tazobactam in Intensive Care Unit Patients: Extended Versus Continuous Infusion

Piperacillin-tazobactam is an acylureido-penicillin-beta-lactamase inhibitor combination and is frequently used in the empirical treatment of hospital-acquired infections because of its antipseudomonal activity. Similar to other beta-lactam antibiotics, piperacillin-tazobactam exhibits time-dependent killing and the T \> MIC appears to be the best outcome predictor. Because a majority of infections are treated empirically, it is necessary to achieve a T \> MIC equal to 50% of the dosing interval (50% T \> MIC) against the most likely pathogens, including those with only moderate susceptibility The aim of this study is to compare the same dose of piperacillin/tazobactam administered by an extended infusion versus a continuous infusion. A pharmacokinetic study will be performed in patients treated by extended (loading dose 4 G/30 min followed by 4 X 4 G /3h) and continuous infusion (loading dose 4 G/30 min followed by 16G /24h).

A population pharmacokinetic analysis with Monte Carlo simulations will be used to determine 95% probability of target attainment (PTA95) versus MIC


Eligibility Criteria:
Inclusion Criteria:

* Adult patients (\> 18 years) admitted on the intensive care unit (surgical and medical surgery).
* Starting a treatment with piperacillin/tazobactam
* Signed informed consent
* Hematocrit \>= 21%
* Available arterial line

Exclusion Criteria:

* age \<18 or \>75 years
* patient's weight \<50 or \>100 kg
* renal insufficiency (estimated clearance \< 50 ML /MIN)
* haemodialysis
* WBC \< 1000 103 µl
* estimated survival \<5 days
* meningitis or other proven infections of the CNS
* IgE-mediated allergy to penicillins
* pregnancy
* patients having participated in another study \<30 days before inclusion in the present study
* retrospectively, marked deterioration of the renal function during the study period
* retrospectively, treatment \< 96 h
Integrating Insulin Delivery and Glucose Sensing in Subcutaneous Tissue for the Treatment of Type-1 Diabetic Patients

The study seeks to use microdialysis and microperfusion techniques to assess the feasibility of combining insulin delivery and glucose sensing at a single subcutaneous tissue site.

Current treatment of in type 1 diabetes comprises the measurement of glucose in capillary blood obtained by fingersticking and administration of exogenous insulin in the form of a subcutaneous bolus injection or subcutaneous infusion. This treatment could be simplified if there were a stable ratio between blood glucose concentration and tissue glucose level at the site of insulin delivery so that tissue glucose levels could be used to estimate blood glucose levels, thereby circumventing the need for fingerstick blood glucose monitoring.

The aim of this study is to ascertain whether a stable ratio between the blood glucose concentration and the glucose levels at the tissue site of insulin infusion exists when this tissue site is exposed to variable insulin infusion rates. To achieve this, microdialysis and microperfusion probes are applied in healthy and type 1 diabetic subjects to perform insulin delivery and glucose sampling at the same adipose tissue site during euglycemic clamps and oral glucose tolerance tests.

Eligibility Criteria:
Inclusion Criteria:

* Type 1 diabetes mellitus patients aged 18 - 65
* Healthy subjects aged 18 - 65
* Informed consent obtained before any trial-related activities.

Diabetic subjects:

* C-peptide negative (≤ 0.05 nmol/L)
* HbA1c (glycosylated haemoglobin A1c) \< 10%

Exclusion Criteria:

* Severe diabetic complications (e.g., proliferative retinopathy, severe nephropathy)
* Female of childbearing potential who is pregnant, breast-feeding or intends to become pregnant or is not using adequate contraceptive methods
* Subject with mental incapacity or language barriers
Ending Tobacco Use Through Interactive Tailored Messaging for Cambodian People Living With HIV/AIDS

The goal of this research study is to test how well an automated text messaging smoking treatment program helps smokers with HIV quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* 1) being aged ≥18 years
* 2) being HIV-positive
* 3) self-reporting as a current combustible cigarette smoker (smoked ≥100 cigarettes in lifetime and currently smoke ≥1 cigarettes/day)
* 4) willing to set a date for a quit attempt within 2 weeks of study enrollment
* 5) being able to provide written informed consent to participate
* 6) being able to read Khmer (score ≥4 points on the Rapid Estimate of Adult Literacy in Medicine-Short Form

Exclusion Criteria:

* 1) history of a medical condition that precludes use of nicotine replacement therapy
* 2) physician/clinician deemed ineligible to participate based on medical or psychiatric condition
* 3) enrolled in another cessation program or use of other cessation medications.
A Study to Evaluate the Effect of Co-administration of Itraconazole or Diltiazem on the Pharmacokinetics of BMS-986177 in Healthy Subjects

The study is being conducted to assess the effects of co-administration of itraconazole or diltiazem, respectively, on the pharmacokinetic (PK) parameters Cmax, AUC(INF), and AUC(0-T) of BMS-986177


Eligibility Criteria:
Inclusion Criteria:

1. Signed Informed Consent
2. Target population: Healthy subjects as determined by medical history, surgical history, physical examination, vital signs, electrocardiogram (ECG), and clinical laboratory determinations.
3. Subjects with body mass index of 18 to 30 kg/m2, inclusive
4. Men, and women of nonchildbearing potential. Women must have documented proof that they are not of childbearing potential and are not breast feeding
5. Males who are sexually active with women of childbearing potential (WOCBP) must agree to follow instructions for method(s) of contraception for the duration of treatment with study drug(s) plus 5 half-lives of the study drug (3 days) plus 90 days (duration of sperm turnover) for a total of 92 days for subjects in the BMS-986177 - diltiazem sequence, and 99 days for subjects in the BMS-986177 - itraconazole sequence.

Exclusion Criteria:

1. Any significant acute or chronic medical illness, including hepatic disease, or any other condition listed as a contraindication in the diltiazem or itraconazole package inserts.
2. Evidence of coagulopathy, prolonged or unexplained clinically significant bleeding, or frequent unexplained bruising or thrombus formation.
3. History of chronic constipation, GI disease, arrhythmias, sinus bradycardia, significant head injury, dizziness or headaches, hemophilia, Rosenthal syndrome, or FX1a deficiency or other coagulopathies, systemic lupus erythematosus.
4. Evidence of organ dysfunction or any clinically significant deviation from normal in physical examination, vital signs, ECG, or clinical laboratory determinations beyond what is consistent with the target population
5. History of allergy to BMS-986177, itraconazole, diltiazem, or related compounds.
Importance of Aldosterone in the Pathogenesis of Hypertensive Heart Disease

The Renin-Angiotensin-Aldosterone-system is important in the development of cardiovascular organ damage caused by arterial hypertension. This study aims at evaluating the importance of aldosterone with regard to hypertension induced damage to the heart. In order to do this the investigators will perform a comparative cross-sectional study in hypertensives and normotensives. In addition as interventional part the hypertensives will be treated with a mineralocorticoid-receptor blocker (spironolactone).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis hypertension (BP higher than 139/89)

Exclusion Criteria:

* Antihypertensive pretreatment
* Contraindications against spironolactone
* Being unable to understand or comply with study procedures
The Effect of Physical Properties of Lipid Emulsions on Gastrointestinal Function

This study will investigate the effects of particle size of different triglyceride emulsions as well as the dynamics of intragastric structure formation and breakdown of the emulsions on GI function, the kinetics of the endocrine and the satiation response in healthy volunteers. 12 healthy participants will be studied on four occasions on four separate days in a double blind randomized design

The mechanisms by which food structure impacts on lipid digestion and the subsequent metabolic processes, including the impact on satiety and satiation, are relatively unexplored, but may have great consequences on the development of effective strategies for weight management. Data from previous studies suggest that (i) the droplet size of a fat emulsion has a distinct influence on GI function and visceral perception (ii) that the biomechanical and digestive properties of the human gut may induce micro structural changes to specifically designed lipid emulsions resulting in different patterns of lipolysis.

The study will assess the effects of triglyceride emulsion with different particle (0.6, 30 μm) sizes and sensitivities to the acidic and shear environment of the stomach on GI function and the kinetics of endocrine and satiation response.

In this study healthy participants will be studied on four occasions on four separate days in a double blind randomized design. The assessment of gastric function will be monitored by novel MRI techniques and breath tests and neurohormonal response by blood sampling.

Eligibility Criteria:
Inclusion criteria:

* Body mass index (BMI): 18.5-24.9 kg/m2,
* Able to communicate well with the investigators
* Provide written consent

Exclusion criteria:

General exclusion criteria:

* Psychiatric (DSM IV) disorders limiting the ability to comply with study requirements
* Epilepsy
* Presence of metallic implants, devices or metallic foreign bodies
* Use of medications influencing upper GI motility within one week of the study (i.e. calcium channel blockers, prokinetic drugs, macrolide antibiotics)
* Evidence of current drug or alcohol abuse
* Previous history of gastrointestinal disease or surgery of the upper GI tract except appendicectomy or hernia repair
* Pregnancy and lactation period