cyrilzakka/clinical-trials huggingface dataset:
Feasabilty and Physiological Effects of a Ventilation Strategy Combining PEEP and Tidal Volume Titration According to Inspiratory and Expiratory Transpulmonary Pressures in ARDS Patients.

Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

Expiratory or inspiratory transpulmonary pressures have been proposed to optimize ventilator settings in patients with ARDS. A positive expiratory transpulmonary pressure may be considered as a target to limt the risk of collapse in dependant lung regions. Some authors propose to titrate PEEP to target an inspiratory transpulmonary pressure of 20cmH20 to limit the risk of overdistension in non-dependant regions.The aim of this study is to assess the feasibility and the physiological effects of a new method based on both expiratory and inspiratory transpulmonary pressures.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Moderate to severe ARDS
* Written informed consent obtained from patient' surrogates

Exclusion Criteria:

* Pneumothorax
* Known pregnancy
* Contraindication to electrical impedance tomography or esophageal pressure measurements
Plasma Circulating Deoxyribonucelic Acid (DNA) as a Response Marker

This study investigates whether the amount of circulating plasma DNA can be used as a response marker for anti-cancer treatment in treating gross tumors.


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancers
* Esophageal cancer
* Undergoing anti-cancer treatments

Exclusion Criteria:

* No distant metastasis
Evaluation of the Impact of the Presence of a Pharmacy Technician on the Quality and Cost of Drug Therapy

The main objective of this study is to evaluate the impact of the presence of a pharmacy technician in a care unit (Hepato-Gastroenterology Department) on detected medication errors.

This is a before-after study consisting of three sequential phases:

Month 1: one month of observation of what is happening in the department Month 2: one month wash out period Month 3: active participation of a pharmacy technician in the department

The secondary objectives of this study are:

A- To assess the impact of the presence of a pharmacy technician on the ratio of the number of patients with at least one medication error / number of included patients hospitalized in the service.

B- To characterize detected medication errors.

C- To identify and evaluate the potential causes of medication errors.

D- To evaluate whether the presence of a pharmacy technician reduces nursing time spent on medication management.

E- To evaluate the economic impact of the presence of a pharmacy technician.

F- To evaluate the acceptability of the intervention by the nursing staff and pharmacy technicians using questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* The patient must be insured or beneficiary of a health insurance plan
* The patient is hospitalized in the Hepato-Gastroenterology Department of the Nîmes University Hospital

Exclusion Criteria:

* The patient is under judicial protection
* The patient, or his/her legal guardian, expresses opposition to participation in the study
* It is impossible to correctly inform the patient
Preload Optimization Guided by Inferior Vena Cava Collapsibility Index

The purpose of this study is to investigate the optimal preload guided by inferior vena cava collapsibility index in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

Post-spinal anesthesia hypotension is a frequent complication during spinal anesthesia for cesarean section. The incidence of post-spinal anesthesia hypotension is as high as 62.1-89.7% if prophylactic measures are not taken. Vasopressors has been highly recommended for routine prevention and/or treatment of post-spinal anesthesia hypotension. As a potential substitute drug for phenylephrine, norepinephrine has gradually been used in parturients undergoing cesarean section. There's some evidence that prophylactic infusion of norepinephrine could effectively reduce the incidence of post-spinal anesthesia hypotension in parturients undergoing cesarean section. However, the investigator's study (NCT03997500) had been shown that inferior vena cava collapsibility index (IVC-CI) markedly decreased in prophylactic norepinephrine infusion versus normal saline after spinal anesthesia and fetal delivery, suggesting that more prudent fluid management is required. The ideal dose of preload and coload is still unknown. Thus, the purpose of this study is to investigate the optimal preload guided by IVC-CI in parturients with prophylactic norepinephrine infusion undergoing cesarean section.

Eligibility Criteria:
Inclusion Criteria:

* 18-40 years
* Primipara or multipara
* Singleton pregnancy ≥37 weeks
* American Society of Anesthesiologists physical status classification I to II
* Scheduled for elective cesarean section under spinal anesthesia

Exclusion Criteria:

* Body height \< 150 cm
* Body weight \> 100 kg or body mass index (BMI) ≥ 40 kg/m2
* Eclampsia or chronic hypertension or baseline blood pressure ≥ 160mmHg
* Hemoglobin \< 7g/dl
* Fetal distress, or known fetal developmental anomaly
A Long-term Administration Study of OPC-41061 in Patients With Autosomal Dominant Polycystic Kidney Disease (ADPKD) [Extension of Study 156-04-001]

Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).

Investigation into the long-term safety and efficacy of OPC-41061 in repeated oral administrations at doses of 15 mg twice daily in patients with ADPKD who completed the preceding dose-finding study (156-04-001).

Eligibility Criteria:
Inclusion Criteria:

* Patients who completed 5-day repeated administrations and the follow-up observation in the preceding study (156-04-001)
* Patients in whom the safety of repeated administration was confirmed based on the investigator's reports from the preceding study (156-04-001)

Exclusion Criteria:

* Patients with serum creatinine concentration of 2.5 mg/dL or higher at the screening examination
* Patients with any of the following complications

  * Uncontrolled hypertension
  * Serious cardiovascular disease (eg. heart failure) or hepatic disease (eg. cirrhosis)"
* Patients with any of the following complications or history thereof

  * Clinically significant drug allergies (anaphylaxis) or hypersensitivity (especially, hypersensitivity to benzazepine derivatives or suspected hypersensitivity thereto)
  * Inability to personally give consent due to a mental disease "
* Patients with SBP (in sitting position) \<90 mm Hg (at screening examination)
* Patients with history of massive bleeding or bleeding tendency
* Patients with a history of drug or alcohol abuse within 6 months prior to the screening examination
* Pregnant women, lactating women, or women who may become or plan to become pregnant
* Patients who received any investigational drug other than OPC-41061 within 30 days prior to commencement of administration of OPC-41061
* Any patient who, in the opinion of the principle investigator or attending investigators, should not participate in the study
Comparison Between Bupivacaine and Bupivacaine With Dexmedetomidine in Caudal Block for Post Operative Pain Control

The aim of this study is to compare the duration of analgesia, sedation, and intra and postoperative hemodynamics. This drug is recently available in Pakistan. To the best of our knowledge, no published data is available in this respect in Pakistan, so this study would in turn help to fill the gap in knowledge in low-resource settings/emerging economy.

Postoperative pain is an annoying subjective sensation for both children and their parents. Almost 80% of the patients undergoing surgery experience postoperative pain, and 80% of them reported moderate to severe pain intensity. Management of postoperative pain has become a major concern in pediatrics. Results of many studies in different countries show that postoperative pain in children is inadequate. Lee et al showed that one of the main reasons for inadequate treatment of postoperative pain in children is difficulties with pain assessment and concerns related to the side effects of opioid analgesics.

The regional anesthetic technique significantly decreases postoperative pain and systemic analgesic requirements. Caudal block, usually combined with general anesthetic technique is one of the most popular, reliable, and safe anesthesia techniques for abdominal and lower limb surgeries in children but the main disadvantage of caudal analgesia is the short duration of action after a single injection.

Bupivacaine is a long-acting, reliable local anesthetic agent that is used as a caudal analgesic, but different auxiliary agents need to be co-administered to improve its analgesic efficiency. Various additives used in the past to increase the pain-free period postoperatively and to decrease the analgesic requirement such as midazolam neostigmine, ketamine, clonidine, and dexmedetomidine.

Dexmedetomidine is a potent and highly selective alpha 2 adrenergic agonists that has been described as safe and effective in many anesthetic applications and analgesic techniques. In contrast to other agents, it has sympatholytic, analgesic, and sedative effects, and is randomly free from side effects except for manageable hypotension and bradycardia.

Eligibility Criteria:
Inclusion Criteria:

* ASA 1 \& 2
* elective per-urethral cystolithotripsy

Exclusion Criteria:

* History of developmental delay or mental retardation
* Known or suspected coagulopathy
* Known allergy to any of the study drugs
* Any signs of infection at the site of the proposed caudal block
* Any caudal anatomical deformity
Bioequivalence Study Comparing Linezolid 600 Mg Oral Suspension With 600 Mg Tablet In Chinese Healthy Male Subjects

The purpose of this study is to estimate the bioequivalence comparing Linezolid 600 MG Oral Suspension with 600 MG tablet in Chinese healthy male subjects. This study data will be used to support Linezolid OS NDA in China.

To support Linezolid NDA in China.

Eligibility Criteria:
Inclusion Criteria:

* Healthy volunteers.
* 18-40 years old, male.
* BMI 19-24kg/m2.

Exclusion Criteria:

* Alcohol, drug, smoke user.
* Sensitive to oxazolidinones antibiotics class drug or heparin.
* Severe medical or psychiatric condition or laboratory abnormality.
* Blood donation.
* 12-ECG abnormal.
* Treatment with study drug; clinically significant.
Extended Remdesivir Infusion Combined With Nirmatrelvir/Ritonavir for Persistent SARS-CoV-2 Infection in Immunocompromised Patients

To evaluate the safety and efficacy of extended remdesivir infusion, targeting on immunocompromised individuals who had positive SARS-CoV-2 PCR despite an oral antiviral agent prescription.

Prolonged viral shedding is commonly observed in immunocompromised patients infected by SARS-CoV-2. Until now, there is no successful clinical trial or guideline to guide optimal treatment for this clinical condition. Here, we aimed to establish a clinical trial with combination of prolonged remdesivir infusion with nirmatrelvir/ritonavir among COVID-19 patients recently receiving b-cell depletion therapy, to evaluate to clinical outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Receive B-cell depletion therapy or bendamustine within 6months
* Laboratory confirmed SARS-CoV-2 infection
* Symptoms onset within 72 hours
* NIAID ordinal score 0-5 upon enrollment

Exclusion Criteria:

* Prior use of any anti-SARS-CoV-2 agents within 2 weeks. Remdesivir or NMV/r initiated within 24 hours is acceptable
* Life expectancy \&amp;lt; 1 month
* Previous adverse effect related to remdesivir or NMV/r
* Concurrent use medicine with drug-drug interaction with NMV/r
* Patients receiving intubation and mechanical ventilation
* eGFR \&amp;lt; 30
* Child pugh score Class C
* Any other condition that in the opinion of the investigator would jeopardize the safety or rights of a subject participating in the trial or would render the subject unable to comply with the protocol.
Echo FLOW Versus (Non-)Invasive Haemodynamics

Rationale: Diligent fluid management is instrumental to improve postoperative outcome, cost and quality of care.

Objective: To determine the accuracy of brachial, femoral and carotid blood flow measurement with ultrasound compared to intermittent transpulmonary thermodilution cardiac output measurement, invasive and non-invasive pulse-contour analysis.

Study design: Observational study - Prospective clinical non-intervention measurement study.

Study population: Adult ASA 1-2 patients, scheduled for open upper GI surgery Intervention (if applicable): Not applicable. We will perform non-invasive ultrasound measurements of the femoral, carotid and brachial blood flow right before induction and under anaesthesia.

Main study parameters/endpoints: Femoral, carotid and brachial blood flow determined by ultrasound and blood flow variation and the accuracy compared to transpulmonary thermodilution cardiac output, stroke volume variation, and pulse-contour analysis derived cardiac output (invasive or non-invasive) at the following time points during surgery; (limited for femoral site as it cannot be measured during surgery): (1) before induction of anaesthesia, (2) after induction, (3) 15 minutes after start of surgery, (4) before and (5) after (1-2 minutes) a fluid bolus, (6) before and (7) after start of vasopressors, (8) before and (9) after Trendelenburg position and (10) after surgery before end of anaesthesia (figure 1). A fluid bolus will be performed as part of standard care (goal-directed fluid therapy). The vasopressor and Trendelenburg position time points are optional measurements. We will also measure (continuous) invasive femoral blood pressure (SBP, DBP, MAP), non-invasive blood pressure, SVV, central venous pressure (when available), heart rate, SpO2, PFI, etCO2.


Eligibility Criteria:
Inclusion Criteria:

* Elective open GI surgery
* Invasive arterial blood pressure monitoring
* Informed consent

Exclusion Criteria:

* Significant stenosis \> 30% or abnormal anatomy of aortic, femoral, carotid or brachial artery
* Cerebrovascular accident
* Atrial fibrillation
* COPD stage 3-4
* Lobectomy / pneumectomy
* Active pneumonia
* Cardiac failure
* Severe heart valve regurgitation or stenosis
* Not able to measure brachial or carotid artery blood flow during surgery
* Contra-indications for femoral arterial catheter placement (e.g., vascular graft)
A Study to Evaluate the Safety and Efficacy of YM150 in Patients With Knee Replacement Surgery

To evaluate the safety and efficacy of twice daily dosing and once daily dosing of YM150 in subjects undergoing primary elective knee replacement surgery


Eligibility Criteria:
Inclusion Criteria:

* Subject is scheduled for elective primary knee arthroplasty
* Written Informed consent obtained

Exclusion Criteria:

* Subject has documented history of previous VTE
* Subject is considered to be at increased risk of VTE
* Subject has active bleeding or any condition associated with increased risk of bleeding
* Subject is planning to have surgery on the contralateral knee at the same time or within 6 weeks after enrollment into the study
A Drug-Drug Interaction Study Between Danoprevir/Low-Dose Ritonavir and Cyclosporine in Healthy Volunteers

This single-dose, randomized, open-label, 2-sequence, 3-period study will evaluate the effect of cyclosporine on the pharmacokinetics of ritonavir-boosted danoprevir (DNV/r) in healthy volunteers. Subjects will be randomized to one of two treatment sequences to receive a single oral dose of DNV/r or cyclosporine. In treatment period 3, subjects will receive a single oral dose of DNV/r plus cyclosporine. Anticipated time on study is 33 days.


Eligibility Criteria:
Inclusion Criteria:

* Male and female healthy volunteers, 18 to 45 years of age inclusive
* Body mass index (BMI) 18.0 to 32.0 kg/m2
* Weight \>/= 50 kg
* Healthy status defined by absence of evidence of any active or chronic disease following detailed medical and surgical history and a complete physical examination
* Nonsmoker
* Females of childbearing potential and males and their female partner(s) of childbearing potential must agree to use 2 forms of contraception, 1 of which must be a barrier method, during the study and for 90 days after the last drug administration (acceptable barrier forms are condom and diaphragm, acceptable non-barrier forms of contraception for this study are non-hormonal intrauterine device and/or spermicide)

Exclusion Criteria:

* Pregnant or lactating females
* Positive results for drugs of abuse in the urine at screening or prior to admission to the clinical site during any study period
* Positive for hepatitis B, hepatitis C or HIV infection
* Current smokers or subjects who have discontinued smoking less than 6 months prior to the first dose of study medication
* Use of hormonal contraceptives (birth control pills, patches or injectable, implantable devices) within 30 days before the first dose of study medication
* Routine chronic use of more than 2 g acetaminophen daily
* Use of any investigational drug or device within 30 days of screening (6 months for biologic therapies) or 5 half-lives of the investigational drug, whichever is longer
* History of clinically significant disease or disorder
* History of clinically significant drug-related allergy (such as anaphylaxis) or hepatotoxicity
* History (within 3 months of screening) of alcohol consumption exceeding 2 standard drinks per day on average (1 standard drink = 10 grams of alcohol)
Chronic Kidney Disease in Teenagers With Congenital Cardiac Disease

The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is not known, but there is evidence of CKD in young adults. In the present study assumption is made that CKD can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence according to the KDIGO criteria by a cross-sectional study, which will enroll patients aged 10 to 15 years. The second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could by chart review and regression analysis.

Background. Acute kidney injury is a common complication of cardiac surgery in children. The prevalence of chronic kidney injury (CKD) following cardiac surgery during childhood is not known. The only study published to date is that of Dimopoulos et al., who has estimated the prevalence of CKD in young adults with congenital cardiac diseases at 40% and the prevalence of stage 2 CKD at 6% (Dimopoulos, Circulation 2008). The study by Dimopoulos et al. also showed that CKD was a risk factor of death in this population. Objectives. In the present study assumption is made that CKD can already by diagnosed in patients at or just before adolescence, and the aim is calculate its prevalence. The second hypothesis is that events occurring peri-operatively during initial surgery or during follow-up could be predictive of CKD.

Methodology. The study has been approved by the Ethical Committee of our institution, and is founded by the Departement de la Recherche Clinique et du Developpement, AP-HP, Paris This is a prospective observational cross-sectional study which will enroll patients 10 to 15 years with congenital cardiac diseases, who have undergone surgical repair during childhood. Only patients who have undergone surgery and follow-up at our institution will be enrolled, to insure complete data. The patients will receive complete information about the study by mail that will be send home prior to the appointment for the cardiologic follow-up. After parental and patient consent, a sample of blood and urine will be collected for purpose of the study. CKD will be diagnosed according to the KDIGO criteria in children (Hogg, Pediatrics 2003). In case of CKD, patients will be informed and given an appointment for nephrological support and follow-up at our institution. The prevalence and stage of CKD will be calculated after completion of inclusions. The risk factors of CKD will be identified retrospectively by chart review and regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Patient aged 10 to15 years, having undergone surgery for congenital heart disease during childhood, and cardiologic follow-up at Necker-Enfants Malades Hospital
* Written informed consent by one parent
* Health insurance

Exclusion Criteria:

* Documented chronic kidney disease of non cardiac origin
* Documented kidney or urinary malformation
* Failure to puncture a peripheral vein
Stripping Massage After Thoracoscopy

This study investigated the effects of stripping massage (SM) on myofascial trigger points in the rhomboid after thoracoscopic surgery.

This study investigated the effects of stripping massage (SM) on myofascial trigger points in the rhomboid after thoracoscopic surgery. Sixty patients with chest pain after thoracoscopic surgery were randomized divided into two equal groups (A and B). Group A (n = 100) received conventional analgesics. Group B (n = 100) received SM twice daily in the active trigger points of the rhomboid for two weeks. The visual analogue scale, a pressure algometer, will be used to evaluate patients' pre- and post-treatment statuses.

This study will compare differences between the current traditional method (using analgesics) and the SM for rhomboid myofascial trigger points for post-thoracoscopic chest pain, and analyze the variables generated by the two different methods including demand time of analgesics, acceptance, and differences of visual analogue scale. The results of the study will use scientific data to prove which way is a good way to take into account of the relief of patient's chest pain.

Eligibility Criteria:
Inclusion Criteria:

* Chest pain with visual analogue scale larger than 3 after thoracoscopic surgery

Exclusion Criteria:

* bleeding tendency
Thalidomide Maintenance Treatment in DLBCL

This is a randomized, multi-center,phase III study to evaluate the ability of thalidomide maintenance therapy to prolong relapse-free survival in diffuse large B cell lymphoma(DLBCL).

This is a randomized, phase III study to evaluate the ability of thalidomide maintenance therapy to prolong relapse-free survival(RFS), in diffuse large B cell lymphoma(DLBCL).Patients will be enrolled after successful standard induction therapy (CR or CRu following standard R-CHOP-like therapy with 8 infusions of rituximab plus CHOP-like chemotherapy (4-8 cycles). Patients will be followed until an event occurs as defined in the protocol. To evaluate the clinical efficacy of thalidomide maintenance therapy as compared to observation in patients with DLBCL who have achieved a complete remission after appropriate first-line therapy, measured by RFS, 226 patients with DLCBL will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* NCCN-IPI\>1,
* Known IPI, cell of origin and DHL at time of diagnosis,
* Negative pregnancy test,
* Men must agree not to father a child during the therapy,
* 6 to 8 cycles R-CHOP/like, total of 8 x Rituximab,
* CR, CRu

Exclusion Criteria:

* Transformed lymphoma,
* Secondary malignancy,
* HIV positive,
* Evidence of CNS involvement,
* Cardiac dysfunction (systolic ejection fraction \<50%),
* Creatinine \> 2.0 mg/dl