cyrilzakka/clinical-trials huggingface dataset:
Role of HVNI in Severe Chest Trauma

to compare the respiratory complications in patient managed with high velocity nasal insufflation versus patients managed with conventional low flow oxygen in patients with severe chest trauma

* Chest trauma are associated with significant morbidity and mortality due to respiratory failure and pneumonia.
* The two main goals of therapy are pain management and pulmonary care and support. There is strong evidence for providing good analgesia to facilitate volume expansion treatment and chest physiotherapy, aiming for deep breathing and effective cough to reduce secretions and prevent the atelectasis.
* Oxygen supplementation is often included as supportive therapy added to bundles of care for patients of chest trauma with rib fractures.

High -velocity nasal insufflation (HVNI ) was first developed for neonates and has gained increasing use in adult patients for prevention and treatment of respiratory failure. High-flow humidified oxygen with flow rates from 30 to100 L/min with high fraction of inspired oxygen( FiO2) is able to be delivered. Positive end-expiratory pressure can be generated, preventing alveoli collapse. The washout of carbon dioxide (CO2)and replacement with enriched O2 purportedly decreases work of breathing and increases breathing effectiveness.

* Routine tests for chest injuries include chest X-rays and computed tomography (CT) scans. Ultrasound has the advantages of being inexpensive, readily available and being free of ionizing radiation .
* In thoracic trauma cases, ultrasonography of the lungs is valuable for evaluating various chest diseases, including chest wall haematoma and fractures, pleural cavity involvement with pleural effusion, haemothorax, and pneumothorax. The ultrasound can also assess the reduce in lung aeration by changing the lung surface and generating distinct patterns as in pulmonary contusions and compression atelectasis.

Eligibility Criteria:
Inclusion Criteria:

* Chest trauma patients with lung injury confirmed by ct imaging

  * the age from 15-55 years old
  * No indication of mechanical ventilation at the time of admission to the intensive care unit

Exclusion Criteria:

* • Patients \< 15years old

  * requiring endotracheal intubation and mechanical ventilation immediately on admission for any cause
  * facial fractures or base of skull fractures
  * Who did not receive a chest computed tomography (CT) scan
  * Glasgow Coma Scale \<10
  * Massive surgical emphysema
  * COPD Patients ( chronic obstructive pulmonary disease )
Aiming Towards Evidence Based Interpretation of Cardiac Biomarkers in Patients Presenting With Chest Pain Using Point of Care Assays

The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.

Ischemic coronary artery disease is an important health challenge and a common cause of death worldwide. Patients with symptoms suggestive of acute coronary syndrome are frequently referred to the emergency department (ED) and impose a high work-load on hospitals. Since 2009, high-sensitivity cardiac troponin (hs-cTn) assays have become a crucial ED tool for differentiating between patients with and without Non-ST-elevation myocardial infarction (NSTEMI). Accordingly, the European Society of Cardiology (ESC) recommends 0-1 hour algorithms that use hs-cTn for rule-out and rule-in of NSTEMI.

Additionally, the clinical suspicion of acute coronary syndrome (ACS) or other life-threating conditions must be low.

Unfortunately, these algorithms have been difficult to implement into routine and clinical practice, and are only used by a limited number of hospitals due to lack of randomized clinical trials and practical obstacles, including turnaround time for troponins.

The aim of the current study is to perform a RCT comparing safety and efficiency of a standard care (in-line with current ESC recommendations) to an algorithm that utilize a POC troponin tests for bedside measurement, the instruments could be located in the ED and return results in few minutes.

Eligibility Criteria:
Inclusion Criteria:

Patients \> 17 years who are referred to the Emergency Department of Haukeland University Hospital with chest pain suspect of ACS

Exclusion Criteria:

1. STEMI (ECG criteria)
2. Patients without STEMI who are immediately transferred to cardiac catheterisation lab (due to heart failure, arrhythmia etc.) without possibility for blood sampling
3. Patients admitted from Nursing homes
4. Patients transferred from other hospitals (e.g. for PCI treatment)
5. Less than 2 months life expectancy from comorbid clinical conditions
6. Not possible to provide informed consent due to cognitive impairment, language problems or other reasons
Supporting Effect of Dronabinol on Behavioral Therapy in Fibromyalgia and Chronic Back Pain

It is known, that a so called "pain memory" usually evolves in chronic pain syndromes which both aggravates the disorder and modifies the patients pain perception. Thus, the principal object of pain therapy is to "delete" this dysfunctional pain memory. The combination of medication, physiotherapy and psychological therapy seems to be the most effective treatment. This study investigates the effect of a concomitant Dronabinol medication (Cannabinoid) on the effectiveness of behavioral therapy. It is hypothesized that the combination of behavioral therapy and Dronabinol will be most effective in deleting the pain memory.

This study investigates the combination of operant behavioral treatment and Cannabinoid medication in patients with fibromyalgia and patients with back pain. It is well known that cannabinoids (THC) accelerate learning processes. It is assumed that the combination of both treatments may exert an synergetic effect. A low dose of THC is used, which ist not expected to have direct analgetic effects. The study also investigates genetic determinants of both disorders and the response to treatment, respectively.

The patients will be randomly assigned to one of four groups: Behavioral therapy and Dronabinol, behavioral therapy and placebo, behavioral therapy only, standard medical therapy. Patients will attend 12 weekly group-sessions (6-8 patients) of behavioral therapy. Behavioral therapy sessions will include training in reducing pain behaviour and establishing active and "healthy" behaviour instead. There will be weekly medical safety visits, in which the patients receive medication and undergo a physical examination (blood and urine samples).

Patients will be evaluated before and after behavioral therapy and will be followed for an additional 6- and 12-months phase. The outcome variables will be recorded by the use of interviews and questionnaires.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of Fibromyalgia meeting ACR-criteria
* Diagnosis of chronic back pain
* Pain duration exceeding 3 months
* Age between 18 and 70 years
* The patient has been informed about the study, understood the information and signed the informed consent form

Exclusion Criteria:

* Tumors, fractures and heavy osteoporosis
* Secondary back pain at arthrosis or degenerative scoliosis
* Radicular back pain
* Other pain syndrome is main problem
* Opiate medication \> 60mg morphine per diem
* Addiction (drugs, alcohol, medicaments)
* Cardiac insufficiency \> NYHA II
* Exercise induced dyspnea, Angina pectoris A detailed version of exclusion criteria: see study protocol
Comparative Study on the Effect of Quadratus Lumborum Block Versus Intrathecal Morphine on the Incidence of Chronic Pain Post Caesarean Section in a University Hospital of Middle-income Country

The aim of this study is to compare the incidence of CPSCP in patients receiving QLB quadratus lumborum block and ITM versus control as a primary outcome and associated risk factors that might predispose patients to develop CPSCP.

The aim of this study is to compare the incidence of chronic post cesarean pain in patients receiving quadratus laborum block and and intrathecal morphine versus control as a primary

Study design:

Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Patients will be randomly allocated to the procedure through closed envelopes and so syringes and medication will be prepared and labelled by anesthetist other than the anesthetist giving the block Data will be collected regarding the demographic data, gestational stage, parity and number of previous cesarean section, previous abdominal surgeries, and narcotic consumption.

Postoperative pain day 1 and day2 will be followed by anesthetist who is blinded to the applied technique used. Follow up for the subsequent period of observation (2,4and 6 months) will be done by the department secretary who will contact the patients by phone to ask them if there is any "concern" after the operation. If the patient refers to a pain at the surgical site that has been lasting for the past three months a call will be conducted by the anesthetist and a referral schedule will be appointed to the pain clinic consultant for further evaluation

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the operating theatre for elective caesarean section

Exclusion Criteria:

* lack of informed consent
* Allergy to drugs used during the study
* Depression and epilepsy that required antidepressants or anticonvulsants
* known coagulopathy as a contraindication for spinal anesthesia
Study of Adverse Renal Effects of Immune Checkpoints Inhibitors

Renal toxic events related to Immune Checkpoints Inhibitors therapy (Nivolumab, Pembrolizumab, Atezolizumab and Ipilimumab) have been recently reported. These were immune-allergic acute interstitial nephritis.

However, no systematic study has ever focused on renal adverse effects. The investigators study here the evolution of renal function and the occurrence of nephrological events in a large monocentric cohort of patients treated with Immune Checkpoints Inhibitors in the Centre Hospitalier Lyon Sud. Nephrological parameters based on Serum Creatinine (SCr), estimate Glomerular Filtration Rate (eGFR) and urinary sediment are monitored. The aim of the study is to determine the incidence of renal events due to Immune Checkpoint Inhibitor treatment, particularly Acute Kidney Injury, (AKI) and identify the clinical presentation, histological description and risk factors.


Eligibility Criteria:
Inclusion Criteria:

All patients treated by one of the Immune Checkpoints inhibitors (Nivolumab, Pembrolizumab, ipilimumab or Atezolizumab), for neoplastic pathology in dermatologic, pneumologic, or medical oncology department.

Exclusion Criteria:

* Minor patients (less than 18y).
* Refusal to consent.
* For statistical analysis: Acute Renal Failure caused by another identified etiology than drug toxicity.
A Multicenter Study on Recombinant Human Thrombopoietin in Management of ITP in Pregnancy

The project was undertaking by Qilu Hospital of Shandong University and other well-known hospitals in China. Aims at evaluating efficacy and safety of rhTPO in management of ITP in pregnancy.

The investigators are undertaking a multicenter, open-labeled, pilot study of 30 ITP patients in pregnancy from Qilu Hospital of Shandong University and other well-known hospitals in China. ITP patients in pregnancy who failed to respond to prednisone, IVIG and developed refractoriness to platelet transfusion will be given rhTPO intravenously at a dose of 300U/kg every day. Dose will be tapered to 300U/kg every other day when platelet count rise over 50×10\^9/L. Maintenance will be continued after delivery and the dose will be further reduced to 300U/kg per week. Platelet count, bleeding and other symptoms will be evaluated before and after treatment. Adverse events will be recorded throughout the study.

Eligibility Criteria:
Inclusion Criteria:

1. Subject is between 18-50 years old.
2. After 12 weeks gestation.
3. Diagnosed with ITP meeting the diagnostic criteria for immune thrombocytopenia.
4. Patients who have no response or relapsed after Corticosteroid or IVIG.
5. Patients developed refractoriness to platelet transfusion.
6. To show a platelet count \< 30×10\^9/L, and with bleeding manifestations.
7. Willing and able to sign written informed consent.

Exclusion Criteria:

1. Received chemotherapy or anticoagulants or other drugs affecting the platelet counts within 3 months before the screening visit.
2. Received second-line ITP-specific treatments (eg, cyclophosphamide, 6-mercaptopurine, vincristine, vinblastine, etc) within 3 months before the screening visit.
3. Current HIV infection or hepatitis B virus or hepatitis C virus infections.
4. Severe medical condition (lung, hepatic or renal disorder) other than chronic ITP. Unstable or uncontrolled disease or condition related to or impacting cardiac function (e.g., unstable angina, congestive heart failure, uncontrolled hypertension or cardiac arrhythmia)
5. Have a known diagnosis of other autoimmune diseases, established in the medical history and laboratory findings with positive results for the determination of antinuclear antibodies, anti-cardiolipin antibodies, lupus anticoagulant or direct Coombs test.
6. Patients who are deemed unsuitable for the study by the investigator.
Immunogenicity and Safety Study of the 13-valent Pneumococcal Polysaccharide Conjugate Vaccine in 2-71 Months Old Healthy Infants and Toddlers (the Youngest Could be 6 Weeks Old)

The purpose of this study is to investigate and valuate the immunogenicity and safety of the 13-valent pneumococcal polysaccharide conjugate vaccine in 2-71 months old healthy infants and toddlers (the youngest could be 6 weeks old)


Eligibility Criteria:
Inclusion Criteria:

* 2-71 months (the youngest could be 6 weeks old) infants or toddlers which are positively healthy based on the medical history, the physical examination and the judgment of the investigator;
* The statutory guardian (or the consignor) of the subject agree his/her child participate in the study, and is willing to sign the informed consent form;
* The subject and his/her statutory guardians (or the consignor) are able to comply with the requests of the clinical study protocol;
* Never be immunized with any pneumococcus vaccine, and didn't get immunization with any other preventive product in the past 10 days (didn't get immunized with attenuated live vaccine in the past 14 days);
* The auxillary temperature ≤37℃.

Exclusion Criteria:

* Has already been immunized with pneumococcus vaccine no matter it is experimental or marketed;
* With the history of invasive disease caused by streptococcus pneumonia by culture;
* With the history of serious allergy to any vaccine or drug, has got fever higher than 39℃ related to immunization with preventive biological product;
* Infant that the birth weight is lighter than 2.5 kg;
* With the history or the family history of seizure, epilepsy, cerebropathy and psychosis ;
* Infant with the abnormal labor (difficult labor, deliver with apparatus) or with the history of asphyxia or nervous damage;
* With the history of thrombocytopenia or other coagulation disorders by definite diagnosis;
* Infant or toddler with pathological jaundice by diagnosis;
* Be known with or suspected with immunological dysfunction, including immunosuppressive therapy (radiotherapy, chemotherapy, corticosteroid hormone, antimetabolites, cytotoxic drug), HIV infection etc. ;
* Be known with serious congenital malformation or serious chronic disease; suffer from congenital malformation or be diagnosed with serious chronic disease (eg. Down syndrome, diabetes mellitus, sickle cell anemia or nervous disease, Guillain-Barre syndrome);
* Be known with or suspected with diseases including: disease of respiratory system, acute infection or the active period of chronic disease, serious cardiovascular disease, hepatic-nephrotic disease, malignant tumor, skin disease;
* Has taken blood product or globulin (the hepatitis B immune globulin is allowed);
* Be participating in other clinical trials;
* Any other situation which is considered to influence the evaluation of the study by investigators .
A Study of The Impact of Severe Hepatic Impairment on the Pharmacokinetics and Safety of Vemurafenib in BRAF V600 Mutation-Positive Cancer Participants

This open-label, Phase I study will evaluate the impact of severe hepatic impairment on the pharmacokinetics and safety of vemurafenib in participants with BRAF V600 mutation positive cancer. Participants will receive vemurafenib 960 milligrams (mg) (normal hepatic function) or 720 mg (severe hepatic impairment) orally twice daily (BID) on Days 1 to 20 (morning dose) and from Day 27 onward until disease progression or unacceptable toxicity occurs.


Eligibility Criteria:
Inclusion Criteria:

* Histologically confirmed BRAF V600 mutation-positive advanced solid malignancy that is metastatic or unresectable and for which standard curative or palliative measures do not exist or are no longer effective
* Normal or impaired hepatic function (hepatic function will be classified according to the NCI Organ Dysfunction Working Group criteria)
* For participants with hepatic impairment: Stable hepatic function for at least 2 weeks (greater than \[\>\] 14 days) before Day 1
* Eastern Cooperative Oncology Group (ECOG) performance status of less than or equal to (\</=) 2
* Participants with a history of recent brain metastases must have completed any radiation therapy at least 4 weeks before Day 1, be without intervening signs of brain lesion progression and not require steroids before starting the protocol (Day 1). Participants with gliomas or known brain metastases who require anticonvulsants must be seizure free for 1 month prior to enrollment
* Life expectancy greater than or eual to (\>/=) 8 weeks
* Adequate hematologic and renal function
* For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraceptive methods that result in a failure rate of less than (\<) 1 percent per year during the treatment period and for at least 6 months after the last dose of study drug

Exclusion Criteria:

* Allergy or hypersensitivity to components of the vemurafenib formulation
* Requirement for immediate or urgent treatment with twice a day vemurafenib and for whom the intermittent schedule of vemurafenib employed during Days 1-26 of this trial is not clinically acceptable
* Chemotherapy, biologic therapy, immunotherapy, or radiotherapy within 4 weeks prior to entering the study, or those who have not recovered from AEs because of agents administered more than 4 weeks earlier
* Gliomas or known brain metastases that require corticosteroids
* History of clinically significant cardiac or pulmonary dysfunction
* Human Immunodeficiency Virus (HIV)-positive participant requiring antiviral treatment including protease inhibitors
* Active infection or chronic infection requiring chronic suppressive antibiotics
* Pregnancy or breastfeeding at Day 1
* History of malabsorption or other clinically significant metabolic dysfunction
* Active autoimmune disease
* Current, recent (within 28 days prior to Day 1), or planned use of any investigational product outside this study
Walk-Training Program for Individuals With Chronic Spinal Cord Injury (SCI)

Cardiovascular disease (CVD) is the common leading cause of death among people with spinal cord injury (SCI) and occurs at an early age in people with SCI as compared to able-bodied people. The findings are consistent in demonstrating a high prevalence of CVD among people with SCI. Lack of physical activity and/or prolonged sitting which is observed in people with SCI due to impaired/loss of motor function is associated with increased risk factors of CVD. By doing this study, researchers hope to learn the effects of walking training on cardiovascular health among people with chronic SCI.


Eligibility Criteria:
Inclusion Criteria:

* Individuals between 18 and 60 years old, who have paraplegia (T1-L2) SCI, and who are scored less than 5 in Functional Independence Measure, Locomotion: Walk
* The onset of SCI must be one year or more at the beginning of the study
* Participants must not be participating in any other similar gait training activities
* Participants must have medical approval from their physician to participate in walk-training

Exclusion Criteria:

* Major Cardiovascular diseases
* Other neurological diseases
* Muscle spasticity (greater than 3 according to Ashworth scale)
* Severe orthopedic issues such as joint stiffness and fractures
* Osteoporosis (bone mineral density T-score less than - 2.5)\[155\]
* Inflammatory diseases or infections
* Open wound and pressure ulcer
* Pregnant women
* Cognitive or psychiatric disorders
* Uncontrolled autonomic dysreflexia; sudden increase in blood pressure
Evaluation of the Impact of Lung Ultrasound on Mortality and Rehospitalization in Patients Admitted to the Emergency Department With Dyspnea

Dyspnea is a frequent reason for referral to emergency departments, leading to a 30-day mortality rate of up to 10% and a 3-month rehospitalization rate of over 30%.

Multiple etiologies, as well as poor performance of clinical examination and chest radiography, lead to a diagnostic error rate of nearly 30% at the end of emergency department care. These diagnostic errors lead to rehospitalization and an excess mortality rate of more than 50% compared to patients with a correct initial diagnosis, which is explained in particular by the use of inappropriate therapies.

Lung ultrasound is a rapid, non-irradiating, non-invasive, inexpensive, reproducible imaging test that can be used at the bedside. It has a better diagnostic performance than chest radiography, commonly performed in emergency departments.The immediate benefit of lung ultrasound for the most common diagnoses in emergency medicine has already been demonstrated.

From an organizational point of view, a few studies have shown a benefit of lung ultrasound in reducing the time spent in emergency departments and the number of additional examinations necessary for the final diagnosis. However, there is no data in the literature on the longer term impact of its use in the emergency department.

The primary objective is to evaluate the impact of performing lung ultrasound in terms of 3-month mortality and rehospitalization as part of the diagnostic process for patients admitted to the emergency department with dyspnea.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Admission to the emergency department with dyspnea defined by:

The functional sign of dyspnea experienced by the patient; Or a clinical sign of respiratory distress.

- Non-opposition of the patient or patient's family if the patient isn't able

Exclusion Criteria:

* Trauma-induced dyspnea;
* Patient being on palliative care;
* Patient with criteria for initial resuscitation with admission to a critical care unit;
* Pregnant women, women in labour or nursing mothers;
* Persons deprived of liberty by judicial or administrative decision;
* Persons under psychiatric care;
* Persons admitted to a health or social institution for purposes other than research;
* Persons of full age subject to a legal protection measure (guardianship, curatorship);