cyrilzakka/clinical-trials huggingface dataset:
Direct REporting of Awareness in MaternitY Patients

DREAMY is a prospective, multi-centre observational cohort study using a mixed methods approach to provide quantitative and qualitative data on accidental awareness under general anaesthesia (AAGA) in obstetric surgery patients. Obstetric patients undergoing surgery, such as emergency caesarian section under general anaesthesia, are thought to be at higher risk than any other surgical cohorts for AAGA. Patients recruited to the study will be screened for AAGA using a standardised questionnaire on three occasions over 30 days. Follow up with structured interviews for all AAGA patients will occur over 12 months.

Background: The challenges of obstetric general anaesthesia practice - including the use of rapid sequence induction, neuromuscular blockade and short duration between anaesthetic induction and start of surgery - may contribute to a higher risk of awareness under general anaesthesia (AAGA) in these patients. The 2014 Royal College of Anaesthetists/Association of Anaesthetists of Great Britain and Ireland National Audit Project 5 highlighted a higher risk of spontaneously reported AAGA in obstetric patients, but it remains unclear what the full (i.e. non-spontaneously reported) risk is. The aim of DREAMY is to establish the incidence of AAGA following general anaesthesia in obstetric surgery patients.

Methods: A standardised Brice questionnaire will be used to screen for recall of intraoperative events in women meeting the eligibility requirements. Questions asked are:

1. What is the last thing you remember before going to sleep?
2. What is the first thing you remember after waking up?
3. Do you remember anything between going to sleep and waking up?
4. Did you dream during your procedure?
5. What was the worst thing about your operation?

The validity of the AAGA incidence will be improved by repetition of the questionnaire on three occasions over thirty days and triangulating using structured follow up interviews in all participants reporting AAGA in questionnaire responses. Participants will be followed up over 12 months and asked for self-reported symptoms of post-traumatic stress disorder (PTSD) using the PCL-5 checklist. The research is being run as a multi-centre, descriptive study over 12 months. General condition and details of the anaesthetic procedure will also be recorded for a logistic regression analysis.

Eligibility Criteria:
Inclusion Criteria:

* Female adults (≥18 years) of ≥ 24/40 gestation
* Receiving general anaesthesia (de novo or regional anaesthesia converted to GA) for surgery with an obstetric indication (e.g. emergency caesarean section, manual removal of placenta, examination under anaesthesia)

Exclusion Criteria:

* Patients too unwell or confused to be able to complete the questionnaire
* Patient refusal
* General anaesthesia for non-obstetric indication (e.g. colorectal or orthopaedic surgery in a pregnant patient)
* Surgery ≥48 hours post-partum
* Unable to communicate verbally/in writing in English language
Treatment Strategies for IgG4-RD Patients With Superficial Organ Involvement

This study has been designed as a 12-month, open-label randomized controlled clinical trial. The study aims to compare the efficacy and safety of three treatment strategies in IgG4-RD patients with superficial organ involvement: Diprospan plus iguratimod, Diprospan plus leflunomide and prednisone plus leflunomide.

90 IgG4-RD patients with superficial organ involvement are enrolled in this study and randomly divided into three groups at a 1:1:1 ratio: patients in group I are treated with Diprospan (1mL im) and then with iguratimod (25mg bid); patients in group Ⅱ are treated with Diprospan (1mL im) and then with leflunomide (10-20mg qd); and patients in group Ⅲ are treated with prednisone (20 mg qd and taper to ≦ 5mg in 3 months) and leflunomide (10-20mg qd). All patients will be followed up for 12 months, and clinical evaluations, laboratory tests, image examinations and IgG4-RD responder index (RI) will be recorded during follow up. The primary endpoint is the difference of relapse rate between two groups at 12 months. The secondary endpoints are relapse time, response rate and side effects.

Eligibility Criteria:
Inclusion Criteria:

* 1. Fulfillment of the 2019 American College of Rheumatology/European League against Rheumatology (ACR/EULAR) IgG4-related disease classification criteria; 2. Newly-onset or relapsed patients who requires initiation or continuation of glucocorticoids treatment; 3. The addition of glucocorticoids was started at lower than 10 mg/d.

Exclusion Criteria:

* 1. Patients who were diagnosed as other autoimmune diseases; 2. Patients who were diagnosed as malignant diseases; 3. Pregnant and lactating women； 4. Active infection: HIV, HCV, HBV, TB； 5. Severe irreversible damage of organ function; 6. Receipt of any biologic therapy or immunosuppressive agent other than GCs.
A New Reproducible Method of Measuring C/D Ratio of Digital Stereo Images of Optic Disc

Development of a novel computer software that will assist in measuring the cup/disc ratio in digital stereo optic disc images.


Eligibility Criteria:
Inclusion Criteria:

Patients who attended the Glaucoma service Patients with at least one pair of documented digital stereo optic disc images Satisfactory Quality of image allowing Cup Disc Ratio Evaluation

Exclusion Criteria:

Unsatisfactory Quality of image allowing Cup Disc Ratio Evaluation Novel software technique unable to process or analyze the image
Heart Failure With Improved Ejection Fraction and Deep Learning

The aim of this study was to design a deep learning-based trained model to assist in HFimpEF diagnosis.


Eligibility Criteria:
Inclusion Criteria:

1. Age \>18 years.
2. The diagnostic criteria of HF follows the 2018 Chinese Guidelines for the Diagnosis and Treatment of Heart Failure, having symptoms of dyspnea, fatigue or decreased activity tolerance, having signs of fluid retention (such as pulmonary congestion and peripheral edema), having echocardiogram abnormalities in cardiac structure and/or function, showing elevated natriuretic peptide levels (BNP\>35 ng/L or/and N-terminal pro-BNP \>125 ng/L).
3. Have reviewing echocardiography after discharge.

Exclusion Criteria:

1. Patients with hypertrophic, restrictive, or invasive cardiomyopathy and congenital or rheumatic heart disease.
2. Patients with heart transplantation during follow-up.
Insertable Cardiac Monitors in Hypertrophic Cardiomyopathy

Hypertrophic cardiomyopathy (HCM) is associated with sudden cardiac death and an increased risk of atrial fibrillation and subsequent embolic event. An insertable cardiac monitor will provide data on cardiac rhythm over a period of 18 months. This will provide an extended monitoring far longer than 24-48 hours of Holter monitoring as is currently usual care. Therefore, detection of arrhythmias could be used in risk stratification and decision-making with regard to offer an implantable defibrillator and anticoagulants.

Detection of non-sustained ventricular tachycardia (NSVT) and atrial fibrillation (AF) using an insertable cardiac device monitor (SJM Confirm XT) which is connected to the patients smart phone and monitored for 18 months.

Eligibility Criteria:
Inclusion Criteria:

* hypertrophic cardiomyopathy

Exclusion Criteria:

* aortic stenosis (moderate, severe)
* hypertrophic cardiomyopathy associated with metabolic disease (e.g. Fabry) and syndromes (e.g. Noonan)
* systolic heart failure
* cardiac device (previous pacemaker, implantable defibrillator )
* history of myocardial infarction
* percutaneous coronary intervention and/or coronary artery by-pass grafting
* pulmonary vein isolation, Maze surgery, ventricular tachycardia ablation, ectopic atrial tachycardia ablation
* renal clearance below 40
* malignancy or other comorbidity with less than five years life expectancy
* pregnancy of planned within 18 months
* drug addiction, severe mental disease
* not able to participate in 18 months follow-up
* 5 years risk more than 6% according HCM risk calculator of European Society of Cardiology guidelines.
Acid-Sensing Ion Channel and Migraine Disease Proof of Concept Study on the Efficacy of Amiloride in the Prophylaxis of Migraine Aura

Recent data suggest involvement of Acid-Sensing Ion Channel channels in the pathophysiology of migraine making these channels a therapeutic target of migraine disease. The implication of Acid-Sensing Ion Channels is discussed through Acid-Sensing Ion Channel-1 which is the most expressed Acid-Sensing Ion Channel channel subtype in the central nervous system. In a mouse model, cortical spreading depression is inhibited by different Acid-Sensing Ion Channel blockers including amiloride which is a non-selective blocker of the Acid-Sensing Ion Channel-1 channel. From a translational perspective, an efficacy of amiloride on a series of migraine patients suffering from severe aura in open conditions. The APAM study is a proof-of-concept study that aims to evaluate the effect of amiloride in the prophylaxis of migraine with aura. This is a randomized crossover study versus placebo conducted in 3 French headache centers.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of migraine with aura code
* At least 1 aura with aura per month in the 3 months prior to inclusion
* No prophylactic antimigraine treatment for at least 1 month prior to inclusion
* For women of childbearing age, use of a reliable contraceptive method at least 3 months before and 1 month after the study
* Signature of written informed consent
* Patient affiliated with Social Security

Exclusion Criteria:

* Existence of contraindication to taking amiloride:

  * Known hypersensitivity to the molecule
  * Hyperkalemia (potassium level (\> 5.5 mmol / l))
  * Use of another hyperkalemic diuretic or potassium salts
  * Renal insufficiency (clearance \<60 ml / min)
  * Severe hepatocellular insufficiency
  * In combination with lithium, converting enzyme inhibitors, angiotensin II inhibitors (except if there is hypokalemia), ciclosporin, tacrolimus, non-antiarrhythmic drugs giving torsades de pointes
* Cardiovascular and renal history, for subjects over 75 years old
* Patient, who from an investigator's point of view would not be compliant to the procedure of the study
* Pregnant or lactating patient
* Patient under trusteeship, under guardianship, protected by law
Ketamine for Pain, Opioid Use, and Mental Health in Orthopedic Trauma Patients

The goal of this clinical trial is to learn whether a single dose of ketamine during surgery can help lower pain, reduce the need for opioid medications, and improve mental health recovery in adults with serious orthopedic injuries. The main questions it aims to answer are:

Does ketamine lower pain after surgery? Does ketamine help reduce how much opioid medicine participants need? Does ketamine improve symptoms of depression and post-traumatic stress disorder (PTSD)? Researchers will compare participants who receive ketamine during surgery to those who receive standard anesthesia without ketamine.

Participants will:

Receive either ketamine or standard anesthesia during surgery Answer survey questions about pain, depression, and PTSD at several points after surgery (from a few days up to 6 months) Be followed by the research team through clinic visits and phone calls

This randomized controlled trial will evaluate whether giving a single dose of intravenous (IV) ketamine during surgery can improve postoperative outcomes for adults with severe orthopedic injuries. Participants will be adults aged 18-65 undergoing surgery for musculoskeletal trauma at a Level I trauma center. All eligible participants will have an Injury Severity Score (ISS) greater than 15.

Participants will be randomly assigned to receive either standard general anesthesia or anesthesia with an added dose of IV ketamine (0.5 mg/kg). The study will track pain levels, opioid use, and symptoms of depression and post-traumatic stress disorder (PTSD) using validated surveys and pain rating scales. Outcomes will be measured at multiple points after surgery, including 1-7 days, 2-3 weeks, 3 months, and 6 months.

This study will help determine if ketamine can improve both physical and mental recovery in people with complex orthopedic trauma, and whether it should be considered as part of routine trauma care.

Eligibility Criteria:
Inclusion Criteria:

* Adults aged 18-65
* Undergoing acute operative fixation for musculoskeletal trauma
* Injury Severity Score (ISS) greater than 15
* Ability to provide informed consent (or consent provided by a legally authorized representative)

Exclusion Criteria:

* Age under 18 or over 65
* Use of ketamine for preoperative or postoperative sedation
* Known allergy or contraindication to ketamine
* Prior unsuccessful ketamine therapy for major depressive disorder (MDD) or PTSD
* Severe psychiatric conditions or psychotic features
* History of dementia or glaucoma
* Currently engaged in trauma-focused cognitive behavioral therapy or PTSD psychotherapy started within the past 3 months
Blood Flow Restriction Training for Treatment of Chronic Patellar Tendinopathy

The purpose of this study is to investigate the clinical and functional outcome of a 12-week rehabilitation regime consisting of Low-Load Blood Flow Restriction compared to Heavy-Slow Resistance training in male patients with chronic unilateral patellar tendinopathy.

Chronic tendinopathy represents a considerable problem in both elite and recreational athletes, and symptoms may affect athletic performance and reduce or even result in retirement from sports participation. The current best treatment is considered to be heavy-slow resistance training (HSRT); however, not all patients are able to cope with heavy exercise loads. Therefore, low-load strength training performed under partial blood flow restriction may be a clinically relevant rehabilitation tool.

This project aims to investigate a new innovative intervention to treat chronic unilateral patellar tendinopathy in male individuals using strength training with low-load muscle contractions performed under partial blood flow restriction (LL-BFR), and to compare the resulting treatment outcome to that of the current best practice (HSRT). Specifically, the effect of LL-BFR will be investigated using a randomized controlled trial design with two groups; 1) a low-load blood flow restriction training program, and 2) a heavy-load slow strength training program. A total sample size of 36 participants are needed when assuming a 10 % dropout.

The training protocol consist of three weekly training sessions during a 12-week rehabilitation period. The primary outcome is measured using the Single-Leg Decline Squat at 12-week.

If LL-BFR proves to be an effective treatment strategy for tendinopathy, it can easily be implemented in daily clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Unilateral patellar tendinopathy
* Chronic (symptoms \>3 months)
* Pain of ≥ 4 during preferred sporting activity on the numerical pain rating scale (NRS; with 0 being no pain and 10 being the worst imaginable pain)
* Ultrasonographical tendon swelling
* Ultrasonographical hypo-echoic area with doppler

Exclusion Criteria:

* Bilateral tendinopathy
* Cardiovascular diseases
* Diabetes
* Smoking
* Previous surgery or trauma to the knee joint with an effect on the presenting clinical condition
* Participants must not have been enrolled in a resistance based-rehabilitation program for the affected patellar tendon within the previous three months
* Previous corticosteroid injection for patellar tendinopathy
Effect of Transcutaneous Auricular Electroacupuncture on Sleep Disturbances in Patients With Rheumatoid Arthritis: A Randomized Double-Blind Clinical Trial

The purpose of this clinical trial is to determine whether transcutaneous auricular vagus nerve stimulation (taVNS) is suitable for improving sleep disorders in patients with rheumatoid arthritis (RA). It will also evaluate the safety of taVNS. The main questions it aims to answer are:

Can taVNS improve the sleep quality of RA patients? What medical issues might RA patients experience while receiving taVNS treatment? Researchers will compare taVNS with a placebo (a similar substance that does not contain the actual treatment) to see if taVNS is effective in improving sleep disorders in RA patients.

Participants will:

Receive taVNS or sham stimulation daily for 4 weeks Keep a daily sleep diary and visit the hospital once a week for check-ups and tests Record their sleep quality and related symptoms This study aims to provide a new, safe, and effective non-drug therapy for sleep disorders related to RA.


Eligibility Criteria:
Inclusion Criteria:

1. Meets the 2010 ACR/EULAR criteria for rheumatoid arthritis.
2. Poor sleep quality (PSQI score \> 7).
3. Disease activity is moderate to low or in remission (DAS28 score ≤ 5.1).
4. No risk of sleep apnea (STOP-Bang questionnaire \< 3).
5. Aged between 18 and 70.
6. The type and dosage of rheumatoid arthritis medication must be stable for at least 4 weeks.
7. Signed informed consent.

Exclusion Criteria:

1. People with acute infectious diseases, whether generalized or localized;
2. Those with severe internal organ diseases (such as coronary heart disease, arrhythmia, malignant tumors, renal failure, etc.);
3. Those working night shifts during the intervention period;
4. Those with other rheumatic diseases such as systemic lupus erythematosus, fibromyalgia, and Sjogren's syndrome;
5. Those undergoing treatment with steroids, sleeping pills, antidepressants, or antipsychotics;
6. Pregnant and breastfeeding women;
7. Those who cannot tolerate transcutaneous auricular electrostimulation.
Trial Evaluating Efficacy and Safety of Anticoagulation in Patients With COVID-19 Infection, Nested in the Corimmuno-19 Cohort

COVID-19 is a respiratory disease caused by a novel coronavirus (SARS-CoV-2) and causes substantial morbidity and mortality. There is currently no vaccine to prevent Covid-19 or infection with SARS-CoV-2 or therapeutic agent to treat COVID-19.

This protocol CORIMUNO19-COAG will evaluate the efficacy and safety of active anticoagulation using heparin: Tinzaparin (INNOHEP®) or unfractionated heparin (Calciparine®, Héparine Sodique Choay®) in COVID-19 patients hospitalized in conventional or intensive care units.

It will use a phase 2 randomized open-label multicentre clinical trial, where patients will be randomly allocated to anticoagulation versus Standard of Care.


Eligibility Criteria:
Inclusion Criteria:

1. group 1 : patients not requiring ICU at admission with mild disease to severe pneumopathy according to The Who Criteria of severity of COVID pneumopathy, and with symptom onset before 14 days, with need for oxygen but No non-invasive ventilation (NIV) or High flow
2. group 2 :

   * Respiratory failure AND requiring mechanical ventilation
   * WHO progression scale ≥ 6
   * No do-not-resuscitate order (DNR order)

Exclusion Criteria:

* Patients with contraindications to anticoagulation

  1. Congenital hemorrhagic disorders
  2. Hypersensitivity to tinzaparin or UHF or to any of the excipients
  3. Current or history of immune-mediated heparin-induced thrombocytopenia
  4. Active major haemorrhage or conditions predisposing to major haemorrhage. Major haemorrhage is defined as fulfilling any one of these three criteria: a) occurs in a critical area or organ (e.g. intracranial, intraspinal, intraocular, retroperitoneal, intra-articular or pericardial, intra-uterine or intramuscular with compartment syndrome), b) causes a fall in haemoglobin level of 20 g/L (1.24 mmol/L) or more, or c) leads to transfusion of 2 or more units of whole blood or red blood cells.
  5. Septic endocarditis
* Patients with need for anticoagulant therapy. For example: atrial fibrillation, venous thromboembolism, mechanical valve, etc.
Study Evaluating the Safety and Pharmacokinetics of a Single Dose of GSI-953

The purpose of the protocol is to assess the initial pharmacokinetic (PK) profile of a single oral dose of GSI-953 to healthy male Japanese subjects and healthy elderly male Japanese subjects.


Eligibility Criteria:
* Healthy males aged 20 - 40 and healthy males aged greater than 65.
* Body mass index range of 17.6 - 26.4 kg/m2 greater than or equal to 45 kg.
* Non-smokers or smoker of fewer than 10 cigarettes a day.
The Effectiveness of Nebulized Hypertonic Saline Solution for Acute Bronchiolitis

This study evaluates the effectiveness of nebulized 3% hypertonic saline solution with salbutamol in the treatment of children under 2 years, hospitalised for acute viral bronchiolitis. Half of the participants will receive nebulized 3% hypertonic saline solution with salbutamol three times daily, the other half will receive standard supportive care, which is the cornerstone of the bronchiolitis management.

Acute viral bronchiolitis is the most common lower respiratory tract infection in infants up to two years old. Currently there is no effective treatment so standard treatment remains supportive care with supplemental oxygen to correct hypoxia, minimal handling to minimise the risk of exhaustion and the provision of fluids.

In recent years some studies have suggested that nebulised hypertonic saline, which improve airway hygiene, may influence the course of the illness and reduce the duration of hospitalisation without significant side effects.

Study protocol: half of the included patients will receive standard treatment for bronchiolitis, which includes only supportive care, the other half will additionally receive nebulized 3% hypertonic saline solution with salbutamol (to avoid potential bronchial obstruction) three times daily.

Eligibility Criteria:
Inclusion Criteria:

* first episode of bronchiolitis: viral lower respiratory tract infection with signs of airway obstruction (hyperinflated lungs, tachypnea, increased work of breathing) and crepitations on auscultations
* admission to the hospital
* Wang CSS between 3 and 9
* randomisation within 4 hours of admission

Exclusion Criteria:

* a history or previous episodes of bronchiolitis/bronchitis
* primary diseases: gastro-oesophageal reflux, chronic cardiac or pulmonary diseases including suspected asthma, immunodeficiency, conditions with hypotonia where more severe course of bronchiolitis is expected
* newborns
* premature infants born \< 36 weeks of gestation
* oxygen saturation \< 85% and patients requiring admission to high dependency or intensive care units at presentation