cyrilzakka/clinical-trials huggingface dataset:
Impact of Stress on Management of BAVU Ventilation (Self-filling Bag With One-way Valve) by Healthcare Professionals.

The goal of this observational study is to learn about the impact of stress on the manual ventilation through Self-filling Bag With One-way Valve. The main question it aims to answer :

how does the ocurence of a stressfull event modify the ventilation delivered in term of pressure, frequency, volume.

Volunter healthcare professionals will take part in a simulation where they will manually ventilate a manikin and ventilation datas will be recorded.

The lung simulator (ASL 5000TM, IngMar Medical) will be connected to a high-fidelity mannequin (SimMan 3G, Laerdal Medical). A continuous, cycle-by-cycle recording of the administered ventilatory parameters will be carried out (recording of pressure, volume and flow curves as a function of time). These curves will then make it possible to determine the main parameters of this ventilation (respiratory frequency, maximum and end-expiratory pressure, tidal volume, etc.).

The healthcare professional will be asked to carry out ventilation with Self-filling Bag With One-way Valve as he is accustomed to doing, during a standardized patient transfer.

Subsequently, an unforeseen event will be added to the situation with continued continuous recording of ventilation modalities.

The personal data that will be requested from healthcare professionals will be: their age, their gender, their seniority in the profession, their place of practice. The stress of healthcare professionals will be assessed using a digital self-assessment scale and the use of a heart rate monitor.

Prior stress and anxiety will be measured in advance by completing several questionnaires before starting the simulation (STAI-T, STAI E, AD ACL).

Eligibility Criteria:
Inclusion Criteria:

* Any healthcare professional who may be required to perform manual ventilation

Exclusion Criteria:

* Unavailability of simulation equipment
* Refusal to participate
A Research Study to Evaluate the Safety of NNC4004-0002 When Given to Participants With Asymptomatic Hyperuricemia

This study will evaluate an investigational drug called NNC4004-0002. "Investigational" means NNC4004-0002 has not been approved for sale/ for clinical use or for the use described in this study/ by any regulatory authority. Its use in this study is experimental. This will be the first time that NNC4004-0002 will be given to human. This study will be testing the ability of the study medicine to lower serum uric acid. The main aim of this study will be to see if the new study medicine is safe and tolerated by the body after a single dose of study medicine in adults with asymptomatic hyperuricemia. Participants will either get NNC4004-0002 (the study medicine), or saline. Which treatment the participant get will be decided by chance. The participant will get the medicine as an injection under their skin. Depending on the dose they will receive, participant may need more than one injection. The study will last for about 19 months in total. The participant will take part in the study for about 7 months. Participant will have approximately 14 visits to the clinic and one of them will be a 4 night in-house stay.


Eligibility Criteria:
Inclusion Criteria:

* Males or females 35 to 75 years of age at the time of signing the informed consent form (ICF).
* Considered to be generally healthy based on medical history, physical examination, and the re-sults of vital signs, electrocardiogram, and clinical laboratory tests performed during the screening visit, as judged by the investigator.
* Body mass index (BMI) 20 to 35 kilogram per meter square (kg/m2) (both inclusive) at screening.
* Serum uric acid levels greater than or equal to (≥) 6.8 miligram per decileter (mg/dL) to less than or equal (≤) 12 mg/dL on 2 consecutive screening samples (the first at the screening visit \[V1\], and the second taken at V2 \[day -1\]; samples at least 7 days apart).

Exclusion Criteria:

* Female who is pregnant, breastfeeding, or intends to become pregnant or is of childbearing po-tential and not using an adequate contraceptive method.
* Male of reproductive age who, or whose female partner(s), is not using an adequate contraceptive method.
* Present or prior history of gout, or present or prior use of serum Uric acid (sUA) lowering medication.
* Serious cardiovascular or hepatic disease, current or past malignancies, or chronic debilitating neurologic, gastrointestinal, or inflammatory diseases.
* History or current diagnosis of chronic history kidney disease.
* Screening alanine transaminase (ALT) or aspartate aminotransferase (AST) values greater than (\>) 2 multiply by (×) upper limit normal (ULN) or total bilirubin \>1.5× ULN.
Bioavailability, Food Effect and Safety, Tolerability of a New Oral Suspension in Comparison to the Marketed Moxifloxacin Tablet in Healthy Adults

The purpose of this study is to describe the pharmacokinetics of a new oral liquid moxifloxacin formulation and the influence of concommitant food intake on the pharmacokinetics in healthy adults compared to the marketed oral tablet. Pharmacokinetics is to see how the body absorbs, distributes and gets rid of the study drug. The absorption of the drug administered in a different dosage form may be altered due to the influence of different excipients used. The safety of moxifloxacin when administered as an oral liquid formulation will also be looked at. Results from this study will be used to guide dosing strategies of the larger clinical trial planned for children.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and female subjects;
* Age: 18 to 55 years (inclusive)
* Body mass index (BMI): above/equal 18 and below/equal 30 kg/m²;
* Women of childbearing age must have a negative pregnancy test and must use adequate contraception throughout the study and for 4 weeks afterwards

Exclusion Criteria:

* Clinically relevant findings in the ECG
* Incompletely cured pre-existing diseases for which it can be assumed that the absorption, distribution, metabolism, elimination and effects of the study drugs will not be normal
* Known hypersensitivity to moxifloxacin, other quinolones or to any of the excipients
* Known severe allergies, non-allergic drug reactions, or multiple drug allergies
* Relevant diseases within the last 4 weeks prior to the first study drug administration
* Febrile illness within 1 week before the first study drug administration
* Patients with a history of tendon disease/disorder related to quinolone treatment.
* Congenital or documented acquired QT prolongation
* Regular use of medicines (with the exception of contraceptives)
* Pregnancy or lactation
* Regular use of therapeutic or recreational drugs
* Smoking more than 25 cigarettes daily
* Regular daily consumption of more than 500 mL of usual beer or the equivalent quantity of approximately 20 g of alcohol in another form
* Suspicion of drug or alcohol abuse
* Special diets preventing the subjects from eating the standard meals during the study
* Regular daily consumption of more than 1 L of xanthin-containing beverages
* Donation of more than 100 mL of blood within 4 weeks before the first study drug administration or of approximately 500 mL in the preceding 3 months
Effect of Virtual Reality on Patients With Acute Pain After Thoracoscopic Surgery

Immersive virtual reality (VR) as a non-pharmaceutical technology may deliver effective behavioral therapies for postsurgical patients with acute pain. To determine the analgesic effects of VR on patients after thoracoscopic surgery. The investigators conducted a randomized clinical trial to determine the postoperative effect of VR on pain relief in patients undergoing thoracoscopic surgery.

Immersive virtual reality (VR) as a non-pharmaceutical technology may deliver effective behavioral therapies for postsurgical patients with acute pain. Patients in the QTC-VR group had to participate in 15-minute interactive games wearing 3D-VR headsets. QTC-VR intervention had functions for breath-relaxation and attention-concentration training. It instructed the patients to breathe deeply with the marine animal's swimming relaxation rhythm and to constantly switch the vision field by rotating their heads and necks to catch animals. Therefore, the investigators conducted a randomized clinical trial to determine the postoperative effect of QTC-VR on pain relief in patients undergoing thoracoscopic surgery.

Eligibility Criteria:
Inclusion Criteria:

1. The patient's age is ≥ 18, regardless of gender.
2. Within one day after thoracoscopic surgery.
3. The NRS of postoperative pain is ≥ four.
4. Having specific internet knowledge and mobile phone reading and writing abilities.
5. Patients voluntarily sign the informed consent form and are willing to complete the follow-up according to the trial protocol.

Exclusion Criteria:

1. Patients have severe cognitive disorders.
2. Patients with previous diagnoses of epilepsy, dementia, migraine, or other neurological diseases may have difficulty using the VR headset.
3. Patients are sensitive to light stimulation.
4. Patients are without stereopsis or with severe hearing impairment.
5. Patients with trauma to the eyes, face, or neck are not comfortable using VR headsets.
6. Patients have severe heart, liver, kidney, blood, digestive, and nervous diseases.
7. Patients previously used the VR headset but found it ineffective.
8. Patients have a history of severe alcoholism, long-term heavy drinking, and symptoms of alcohol dependence.
9. Patients have participated in any analgesic intervention study in the past week.
10. Women have pregnancy plans during the follow-up period of the study.
11. Patients and their families work in digital health or pharmaceutical companies for acute or chronic pain management.
12. Patients cannot use electronic devices such as smartphones.
Endoscopic Submucosal Injection of Indocyanine Green Before Laparoscopic Radical Resection for Colorectal Cancer

Prospective registry study of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer

To observe the imaging result of endoscopic submucosal injection of indocyanine green before laparoscopic radical resection for colorectal cancer, and analyze the relevant factors, so as to guide the submucosal injection of preoperative indocyanine green better.

This study is prospective and observational. In order to analyze the related factors that affect the imaging effect, we enrolled patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical resection for colorectal cancer.

Eligibility Criteria:
Inclusion Criteria:

* Patients who were to undergo indocyanine green fluorescence imaging for laparoscopic radical operation of colorectal cancer.

Exclusion Criteria:

* have simultaneously other cancer

  * have severe systemic inflammatory disease ,serious illness such as diabetes, chronic lung diseases
  * have gastrointestinal surgery
  * Indocyanine green or iodine allergy
  * the period is too late or the tumor is too large to carry on a laparoscopic surgery.
Study of LED Phototherapy for Musculoligamentous Lesions

The purpose of this study is to determine whether LED phototherapy using combined red and near infrared light (approved: Ministry of Health of Russian Federation No. 29/06070997/1080-00, EUROCAT Certificate No. CP033321-IV) is effective in the treatment of musculoligamentous lesions in physiotherapy practice


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of acute or chronic musculoligamentous lesion
* Must be able to understand instructions and fill in auto administered questionnaires
* Informed consent

Exclusion Criteria:

* Use of oral corticosteroids or corticosteroid injections
* Systemic diseases
* General contraindications for phototherapy
Effectiveness of an Oxygen-nitrous Oxide Mixture During Physical Therapy for Frozen Shoulder

The purpose of this study is to determine whether or not the use of an equimolar mixture of oxygen and nitrous oxide during the physical therapy for patients suffering from frozen shoulder (adhesive shoulder capsulitis) results in a gain in shoulder amplitude (Constant Score) and less pain as compared to patients undergoing physical therapy without this treatment.


Eligibility Criteria:
Inclusion Criteria:

* Affiliated with a social security system
* Has signed the consent form
* Patient has a painful, or initially painful but stable frozen shoulder (adhesive capsulitis): stiffening characterized by a passive loss of amplitude on three planes. This loss of amplitude is greater than or equal to 50% of controlateral amplitude when the controlateral shoulder is considered as normal. Otherwise, the loss of amplitude is greater than or equal to 50% of normal anatomical values.
* Radiography confirms the integrity of the glenohumeral interspace.

Exclusion Criteria:

* Intercurrent, evolving or unstable pathology: cancer, advanced cardio-vascular pathology, severe infection
* The patient is taking a treatment that may interfere with the study (eg corticoids, pain killers, chemotherapy)
* Contra-indication for physical therapy
* Coagulopathy
* Advanced diabetes mellitus, with neurological or joint complications
* Contra indication for the experimental treatment
* Pregnant or nursing women
* Patient's mental state prevents him/her from understanding the nature of the study, its objectives and potential consequences.
* Patient under guardianship
* Patient is in an exclusion period determined by a previous study
* Patient not able to follow protocol constraints or timetable
* Medical history of local infection, polyarthritis or neuropathy that might explain the shoulder pain.
* Absence of radiculopathy of cervical origin, of rotator cuff tears or evolving shoulder tendinopathy, of severe omarthrose
Imaging Tau in Alzheimer's Disease and Normal Aging

This study is being done to learn about tau tangles in Alzheimer's disease. A type of PET scan is used to measure the abnormal accumulation of protein called tau in the brain. These are thought to be involved in Alzheimer's disease. The investigators will also perform brain MRI and to tests to measure the participant's memory and thinking.

This study is being done to determine the relationship between tau tangles and cognitive impairment in elderly subjects with different clinical and biomarker profiles of Alzheimer's disease (AD). Subjects will undergo screen that includes neuropsychological testing and brain MRI. This study uses a special type of scan called a PET scan to take pictures of the brain. During the PET scan, a special radioactive dye called 18F-THK-5351 is injected into the body. 18F-THK-5351 sticks to abnormal tangles made of the protein tau. Subjects will have the option to have lumbar puncture performed to measure CSF concentrations of biomarkers.

Eligibility Criteria:
Inclusion Criteria:

1. Age 50 and older.
2. Meet criteria for either a) amnestic mild cognitive impairment (single or mixed domain) or mild Alzheimer's disease, or b) have no cognitive impairment, based on history, exam, neuropsychological testing, and consensus diagnosis. MCI and mild AD patients must have Clinical Dementia Rating scale score of 0.5 or 1. Unimpaired subjects must have Clinical Dementia Rating scale score of 0.
3. Subjects unable to provide informed consent must have a surrogate decision maker.
4. Written and oral fluency in English or Spanish.
5. Able to participate in all scheduled evaluations and to complete all required tests and procedures.
6. In the opinion of the investigator, the subject must be considered likely to comply with the study protocol and to have a high probability of completing the study.

Exclusion Criteria:

1. Past or present history of certain brain disorders other than MCI or AD.
2. Certain significant medical conditions, which make study procedures of the current study unsafe. Such serious medical conditions include uncontrolled epilepsy and multiple serious injuries.
3. Contraindication to MRI scanning.
4. Conditions precluding entry into the scanners (e.g. morbid obesity, claustrophobia, etc.).
5. History of kidney disease or presence of impaired kidney function based on laboratory tests at the screening visit.
6. History of liver disease or presence of impaired liver function based on laboratory tests at the screening visit.
7. Participation in the last year in a clinical trial for a disease-modifying drug for AD.
8. Inability to have a catheter in subject's vein for the injection of radioligand.
9. Inability to have blood drawn from subject's veins.
Risk of Failed Epidural in Patients With and Without Chronic Pain and Opioid Use

Patients with chronic pain syndrome (CPS) may develop central sensitization wich may lead to increased pain intensity and lower pain threshold sometimes to the extend of hyperalgesia and allodynia. Furthermore, patients with daily use of opioids may develop opioid tolerance, and to a lesser extent opioid induced hyperalgesia.

These factors may lead to a higher pain intensity in the perioperative setting resulting in the observed increased opioid dosage needed to treat the acute pain. Furthermore opioid titration may be difficult with higher levels of pain and a higher risk of opioid related adverse effects incl. respiratory depression and sedation.

The factors above advocate for utilizing opioid sparing analgesic techniques. In our department as in many others we use an multimodal opioid sparing approach for surgical procedures including epidural anesthesia (EA) as a standard part of the perioperative analgesia strategy after upper laparotomy, as a sufficient epidural anesthesia has shown to provide a stable and often better pain relief than systemic opioids in these patients.

Clinically, there is a suspicion that patients with CPS on fixed opioid treatment have a higher frequency of need for epidural optimization, despite the lack of an anatomical reason for this. One potential explanation could be an altered nociception, requesting another EA strategy than in non-opioid patients.

Purpose and hypothesis This study will explore the frequency of failed EA, defined as EA with insufficient analgesic effect to the extent were replacements of the epidural is needed within the first 5 postoperative days (PODs), testing the hypothesis that failed epidural occurs more frequent in patients with CPS on fixed opioid treatment than in non-opioid patients without CPS.


Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective laparotomy with epidural anesthesia as a part of the postoperative pain treatment
* For the intervention group - Patients with chronic pain disorder defined as pain for more than 3 months and a daily use of opioids regardless of dosage.
* For the control group - No chronic pain disorder defined as no daily use of opioid or other medicine with strong analgetic effect. A daily use of Acetaminophen and NSAIDs were deemed acceptable.

Exclusion Criteria:

* Patients with substance abuse
* Suspected withdrawal due to opioid deficiency - noted in the medical chart
International, Multicenter Study of a Twenty-eight Week, Open-label, Titrated Oral Lixivaptan Administration in Patients With Chronic Hyponatremia: Extension to Studies CK-LX3401, 3405, and 3430

To evaluate the overall safety and continued efficacy of oral lixivaptan capsules in subjects with euvolemic and hypervolemic hyponatremia

Phase I and Phase II clinical trials have demonstrated that lixivaptan may play an important role in treating hyponatremia and the signs and symptoms of water retention associated with HF, LCWA and SIADH. Lixivaptan was previously evaluated in disease states characterized by hyponatremia with euvolemia (SIADH) and hyponatremia combined with fluid overload (HF, LCWA). Lixivaptan demonstrated correction in serum sodium concentration together with marked aquaresis in patients with hyponatremia.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women 18 years of age or older
2. Ability to provide informed consent or assent
3. Prior participation in a lixivaptan hyponatremia trial with evidence of continued need or desire for therapy

Exclusion Criteria:

1. A current medical condition where long-term treatment with an aquaretic agent may present an undue risk to the patient
2. Hyponatremia which is acute, reversible, artificial or due to conditions not associated with vasopressin excess or likely to respond to aquaretic therapy
3. Hyponatremia due to reversible medical condition or therapy
4. Conditions associated with an independent imminent risk of morbidity and mortality
Image Supported Lead Placement in CRT

Cardiac resynchronization therapy (CRT) is an established pacemaker therapy for patients with symptomatic chronic heart failure, but is hampered by a non-response rate of 30-40%. Optimising left ventricular (LV) lead placement is the cornerstone of improving treatment. The optimal location for the lead is remote from scar but within segments demonstrating late electromechanical activation. The present study aims to investigate the efficacy and clinical effect of the use of real-time guided lead placement using cardiac MRI and fluoroscopy in a blinded, multicenter, randomized controlled trial.


Eligibility Criteria:
Inclusion Criteria:

* Heart failure with LV ejection fraction ≤ 35%;
* New York Heart Association class II, III, or IV (ambulatory);
* Optimal medical treatment that is tolerable;
* Left bundle branch block (LBBB) and QRS ≥ 130 ms, OR non-LBBB and QRS ≥ 150 ms.

Exclusion Criteria:

* Pregnancy or lactation;
* Subjects with impaired renal function (severe renal insufficiency, GFR \< 30 ml/min/1.73m2);
* Atrial fibrillation or atrial fibrillation during MRI
* Documented allergic reaction to gadolinium;
* Impossibility to undergo an MRI scan;
* Participation in another clinical study that prohibits any procedures other than standard.
A Multiple Ascending Dose Study of RO4905417 in Healthy Volunteers and Patients With Peripheral Arterial Disease (PAD).

This single center, multiple ascending dose study will assess the safety, tolerability, pharmacokinetics and pharmacodynamics of RO4905417 at different doses in healthy volunteers and patients with peripheral arterial disease. Three groups of 10 healthy volunteers will receive RO4905417 (either 3mg/kg, 7mg/kg or 20mg/kg) or placebo iv every 28 days for a total of 3 infusions. In addition, two groups of 6 PAD patients will receive RO4905417 (either 3mg/kg, 7mg/kg) or placebo and 1 group of 20 PAD patients will receive 20mg/kg RO4905417 or placebo iv every 28 days for a total of three infusions. The study will have an adaptive design with ongoing assessment of safety and tolerability prior to initiation of the next dose. All subjects will receive 3 doses of RO4905417 or matching placebo at 28 day intervals. The anticipated time on study treatment is 3-12 months, and the target sample size is \<100 individuals.


Eligibility Criteria:
Inclusion Criteria:

* healthy males and females aged 18-65 years (Arms 1,2,5,6,9,10);
* BMI 18-30kg/m2 (Arms 1,2,5,6,9,10);
* males and females aged 45-75 years with confirmed stable PAD (Arms 3,4,7,8,11,12);
* on a stable dose of statin, aspirin or clopidogrel for at least one month prior to the study (Arms 3,4,7,8,11,12);
* BMI 17.5-35kg/m2 (Arms 3,4,7,8,11,12).

Exclusion Criteria:

* patients with pain at rest and/or local complications;
* history of any cardiovascular event within the previous 6 months;
* treatment with drugs potentially affecting coagulation time or platelet aggregation (except aspirin or clopidogrel);
* evidence of hepatic or renal impairment;
* history of bleeding disorders.