cyrilzakka/clinical-trials huggingface dataset:
HFNC Compared With Facial Mask in Patients With Chest Trauma Patients

Guidelines for noninvasive ventilation (NIV) recommend continuous positive airway pressure in patients with thoracic trauma who remain hypoxic . However, no any suggestion was applied for high flow nasal cannula (HFNC). Therefore, Our aim was to determine whether HFNC reduces intubation in severe trauma-related hypoxemia.

This would be a three-center randomized clinical trial of a level I trauma hospital. Inclusion criteria were patients with Arterial oxygen level (Pao2/)fraction of inspired oxygen inspired oxygen fraction(Fio2)\<300 while receiving oxygen by high-flow mask within the first 72 h after thoracic trauma. Patients were randomized to remain on high-flow oxygen mask/ noninvasive ventilation or to receive HFNC. The interface was selected based on the associated injuries.

Eligibility Criteria:
Inclusion Criteria:

Patients who have the following condition within 72 hours of chest trauma despite receiving standard nasal cannula oxygen therapy \[≥10 L/min\], are eligible for inclusion.

* severe hypoxemic respiratory failure \[Arterial partial pressure of oxygen (PaO2)/fraction of inspired oxygen fraction(FiO2) \<300 mmHg\]
* with a respiratory rate \>25 breaths/minute and difficulty breathing, or respiratory distress
* PaCO2 of 45 mmHg or higher (if the patient requires emergency surgery with endotracheal intubation and mechanical ventilation, the time of inclusion will be the start of the post-extubation period. (Note: For patients who receive emergency trauma surgery with endotracheal intubation and mechanical ventilation, the time of inclusion assessment will be 72 hours after extubation.)

Exclusion Criteria:

1. Patients with a Glasgow Coma Scale less than 8 or severe brain injury.
2. Patients with any contraindications to non-invasive ventilation, including acute gastrointestinal bleeding, upper airway obstruction, or hemodynamic instability.
3. Facial trauma involving skull base fractures, facial bone fractures, or orbital floor fractures.
4. Severe injuries involving the nasal sinuses.
5. Patients with cervical spine injuries.
6. Patients with increased intracranial pressure.
7. Patients with facial, nasal, or airway structural abnormalities or surgery that prevents the use of appropriate nasal cannula.
8. Patients after upper airway surgery.
9. Patients who are unable to clearly express their willingness to sign informed consent.
The Effects of Combined Spinal Epidurals on Fever During Labor of First-Time Mothers

The purpose of this study is to determine if the epidural of local anesthetics has an effect on fever that may occur in first time mothers during labor.

Intrapartum fever (fever during labor) is a real and potentially devastating problem. Infants delivered at term who have been exposed to the mother having a fever during labor have a \>9 fold increased risk of cerebral palsy. Studies have also shown an increased risk of neonatal encephalopathy associated with fever during labor. Maternal fever in the absence of infection is associated with a 4 fold increased risk of neonatal hypoxic encephalopathy and 3.4 fold increased risk of unexplained neonatal seizures.

The likely role of inflammatory mediators in the process of maternal fever (temperature \>100.4), regardless of etiology, makes it important to further investigational studies in an effort to discover the etiology of intrapartum fever associated with epidural analgesia. If an inflammatory trigger (i.e., the injection of epidural local anesthetics) can be identified or delayed, then the risks of maternal hyperthermia can be minimized and/ or eliminated.

The greatest risk of fever with epidural labor analgesia is seen in women having their first child. This is the same population associated with prolonged labor. Although intrapartum fever has a very low incidence overall, 11-33% of first-time mothers will eventually develop fever \>100.4 during epidural analgesia. Although the degree of rise in temperature occurs very slowly, it has been shown to be significant enough to cause increased neonatal sepsis workup and antibiotic coverage for both the mother and the neonate.

Eligibility Criteria:
Inclusion Criteria:

* having first child (nulliparous)
* term pregnancy (\> 37 weeks)
* vertex presentation
* singleton gestation
* ability to provide informed consent
* request for analgesia for labor pain

Exclusion Criteria:

* birth of second or more child (multiparous)
* preterm pregnancy (\< 37 weeks)
* presentation other than vertex (ie. breech, transverse)
* diabetic
* admit temperature \> 99.5
* active drug/alcohol dependence
* active genital herpes infection
* allergy to anesthetics used
A Study to Assess the Safety, Tolerability and Pharmacokinetics of Single and Multiple Ascending Doses of Fidaxomicin in Healthy Male Japanese and Caucasian Subjects

The purpose of this study is to evaluate the safety, tolerability and pharmacokinetics (PK) of single and multiple ascending doses of fidaxomicin in healthy subjects. This study will also compare the safety, tolerability and PK of single and multiple doses of fidaxomicin in healthy Japanese and Caucasian subjects.

Eligible subjects will check into the unit on Day-2 and remain confined to the clinical unit until Day 17.

Cohorts 2 and 3, which may run in parallel, will only be enrolled after review of the available safety data of Cohort 1 by the Safety Review Team.

Eligibility Criteria:
Inclusion Criteria:

1. Male subject and their female spouse/partners who are of childbearing potential must be using highly effective contraception consisting of two forms of birth control (one of which must be a barrier method) starting at Screening and continuing throughout the study period and for 90 days after final study drug administration
2. Male subject must not donate sperm starting at Screening and throughout the study period and for at least 90 days after final study drug administration

   Inclusion Criteria for Japanese Subjects
3. The subject is a healthy Japanese male who maintains the Japanese lifestyle, including diet and has a body mass index (BMI) of 18.0 to 28.0 kg/m2, inclusive.

   Inclusion Criteria for Caucasian Subjects
4. The subject is a healthy Caucasian male and has a BMI of 18.0 to 32.0 kg/m2, inclusive

Exclusion Criteria:

1. The subject has any clinically significant disease history
2. The subject has a history of or current C.difficile infection or history of stomach or intestinal surgery or resection that would potentially alter absorption and/or excretion of orally administered drugs (history of appendectomy, hernia repair, and/or cholecystectomy is permitted)
3. The subject has any clinically significant abnormality
4. The subject has a resting (i.e., seated for 5 minutes) pulse \<40 or \>90 beats per minute (bpm) at Screening or Day -2
5. The subject has hypertension (defined as seated systolic blood pressure \[SBP\] \>140 mmHg or seated diastolic blood pressure \[DBP\] \>90 mmHg) or hypotension (defined as seated SBP \<90 mmHg or seated DBP \<50 mmHg) at Screening or Day -2
6. The subject has/had a symptomatic, viral, bacterial (including upper respiratory infection), or fungal (non-cutaneous) infection within 1 week prior to clinic check-in on Day -2
7. The subject has a history of chronic diarrhea or constipation
8. The subject has a positive result for hepatitis C antibodies or hepatitis B surface antigen at Screening or has a known positive history of human immunodeficiency virus (HIV)
9. The subject has a known or suspected allergy or hypersensitivity to any of the components of fidaxomicin, the macrolide antibacterial class of compounds, or a history of multiple and/or severe allergies to drugs or foods or a history of severe anaphylactic reactions
Evaluation of the Management of Diabetic Foot Ulcers by Telemedicine on the Number of Hospital Days in Diabetic Patients

The TELEPIED project aims to show that it is possible to reduce the number of hospitalization days of a patient with ulcers of the foot thanks to a new organization of care, based on the intervention of a coordinating nurse interacting with the nurse in charge of the patient thanks to a telemedicine tool allowing the transfer of photos and ensuring itself a regular follow-up of the evolution of the wound and adapting the support nurse to the home if necessary.

It is a monocenter, randomized, in parallel study, in 180 diabetic patients with ulcers of the foot.

Patients included in the conventional group will be followed according to the usual practice Patients included in the "telepied" group will benefit from a personalized accompaniment by a nurse referring to diabetic foot ulcers who will guide and advise the nurse at home by acting by delegating tasks of the investigator.

The patient will be visited by the referring nurse every 15 days. During these visits, the referring nurse will have the objective to evaluate the evolution of the ulcer as well as the care performed. This visit also allows a close personalized accompaniment for the patient, who will benefit from an education adapted to the characteristics of ulcer (discharge modalities for example ..) and its way of life.

Every patients will be followed for one year (12 months).


Eligibility Criteria:
Inclusion Criteria:

* Patients over 18 years
* Diabetic patients with foot ulcer
* Patient who agreed to participate in the study and sign free and informed consent
* Patient affiliated to a social security scheme

Exclusion Criteria:

* Pregnant Woman
* Patient deprived of liberty by a judicial or administrative decision or a person subject to a legal protection measure
* Patient already involved in another clinical trial protocol
F-18-AV-45 Uptake, Spot Sign Presence and Cerebral Amyloid Angiopathy (CAA) in Primary Intracranial Hemorrhage (ICH)

Florbetapir F 18 is an experimental radioactive drug that may allow doctors to image changes in the brain using a PET (Positron Emission Tomography) scanner. The purpose of this study is to evaluate the imaging characteristics of, Florbetapir F 18 (also known as 18F-AV-45) in patients who have previously undergone bleeding in their brains. Florbetapir F 18 binds to amyloid-ß peptide (Aß) that accumulates in the brains of patients with bleeding. These accumulations are called amyloid plaques and when extensive are labeled cerebral amyloid angiopathy (CAA). Florbetapir F 18 sticks to the amyloid plaques in the brain and emits a low level of gamma rays which can be detected by a PET camera.

MRI detected microbleeds have been identified as markers of clinically silent hemorrhage from bleeding-prone vessels. Another imaging marker of vessel damage and risk of bleeding is the spot sign (SS). Finally, certain genetic signatures (ApoE genotype) have been shown to be associated with Aß deposition in the brain or predispose patients to higher risks of bleeding. This research study will explore the interactions of these factors and understand the physiology of intracerebral bleeding.


Eligibility Criteria:
Inclusion Criteria:

* Prior intracranial hemorrhage at least 3 months prior
* Patients \>18 years

Exclusion Criteria:

1. Modified Rankin score \>3.
2. Clinically significant medical comorbidities which in the opinion of the investigator might pose a potential safety risk to the subject.
3. Women of childbearing potential who are not surgically sterile, not refraining from sexual activity or not using reliable methods of contraception.
4. Have a history of relevant severe drug allergy or hypersensitivity
5. Patients who withdraw consent. Age and gender-matched microbleed patients previously demonstrating MRI microbleeds without prior macrobleeds will be recruited from stroke clinic
Italian Registry of Minimally Invasive Pancreatic Surgery

Assess the prevalence of minimally invasive pancreatic surgery in the country and its outcomes

Since 1994, when the first pancreatectomy surgeries, distal and proximal, conducted minimally invasively, were published, efforts have been made to understand the value of this approach in the context of a surgery as complex and burdened with specific complications as pancreatic surgery. The adoption of such an approach with regard to pancreatic surgery has been less rapid and parceled out than in other surgical fields and not supported by a large body of scientific publications. However, worldwide, referral centers for pancreatic surgery routinely use the minimally invasive approach in selected cases, and its diffusion has recently shown a marked increase. Even in Italy, a recent survey promoted by some of the major surgical societies showed a fair diffusion of the use of the minimally invasive approach in pancreatic surgery but with extremely variable ways and uses in the different territorial realities with evident and potentially risky paradoxes. Monitoring the diffusion of minimally invasive pancreatic surgery, the methods of application and the results of this approach has become of primary importance and for this reason the foundation of a national registry has been proposed by several scientific surgical societies.

This study aims to investigate what is the real diffusion of minimally invasive techniques in Italy and what postoperative outcomes the adoption of this approach generates.

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years;
* Underwent minimally invasive pancreatic surgery

Exclusion Criteria:

* Pregnant woman
* Minor or unable to give informed consent
Development of Distress Management Algorithms Using Mobile Device Based Health Logs in Breast Cancer Survivors

Distress monitoring is an important issue in cancer survivors. However, conventional distress screening is very difficult to perform. This study investigates the efficacy of wearable device as a tool of distress monitoring in breast cancer survivors.


Eligibility Criteria:
Inclusion Criteria:

* Stage 0-III breast cancer

Exclusion Criteria:

* Stage IV breast cancer
* Breast cancer recurrence or metastasis
* Severe medical illness
A Phase II Trial to Assess the Safety and Immunogenicity of DNA Priming Administered by the ID Zetajet® With or Without ID Derma Vax™ Electroporation Followed by IM MVA Boosting in Healthy Volunteers in Tanzania and Mozambique

Electroporation will increase the efficiency of DNA priming in terms of immune responses and will lead to a dose sparing DNA vaccine regimen. Furthermore increased DNA vaccine concentration will reduce the number of shots necessary to deliver the full dose and induce comparable immune responses as with lower DNA vaccine concentrations.


Eligibility Criteria:
Inclusion Criteria:

* Willing to undergo counselling and HIV testing.
* Have a negative antigen/antibody ELISA for HIV infection.
* Able to give informed consent.
* Basic abilities to read and write.
* Satisfactory completion of an assessment of understanding prior to enrolment defined as 90% correct answers after three opportunities to take test.
* Resident of the region where the study is taking place.
* At low risk of HIV infection.
* Verbal assurances for adequate birth control measures.
* Healthy as evidenced by clinical and laboratory measures

Exclusion Criteria:

* At risk of HIV infection.
* Active tuberculosis.
* A history of immunodeficiency, ongoing medical and/or psychiatric condition and/or chronic illness requiring continuous or frequent medical intervention.
* Autoimmune disease.
* Hives and severe eczema.
* Substance abuse problems.
* History of grand-mal epilepsy.
* Received blood or blood products or immunoglobulins in the past 3 months.
* Receiving immunosuppressive therapy such as systemic corticosteroids or cancer chemotherapy.
* Use of experimental therapeutic agents within 30 days of study entry.
* History of cardiac disease
Using Energy Availability as a Strategy to Explore the Effects of Relative Energy Deficiency in Sport on Athletes

The goal of this type of study:clinical trial is to test, compare etc. In describe participant population health conditions. Participants will diet record,maintain training and life.

Relative energy deficiency in sport (RED-S) can negatively affect the health and performance of both male and female athletes. The underlying etiology of RED-S is low energy availability (LEA), which occurs when there is insufficient dietary energy intake to meet exercise energy expenditure. This syndrome refers to impaired physiological function, including metabolic rate, menstrual function, bone health, immunity, protein synthesis, and cardiovascular health. Strategies to support athlete health and training energy availability are an integral part of optimizing training outcomes and preparing for competition. This project aims to investigate the prevalence of RED-S among Taiwanese athletes by recruiting athletes of different age groups and to find the relevance of dietary risk factors to enhance energy availability. This project intends to recruit athletes in aesthetic sports and weight-sensitive sports to study the prevalence of RED-S in different training periods, and to find out the relationship between the possible dietary risk factors and the improvement of energy availability, and to understand whether the strategy of improving energy availability through the concept of nutritional supplements has a positive effect on the relative energy deficiency of athletes. In the first year of this study, the prevalence of relative energy deficits, dietary risk factors in pre-season, competition and off-season will be studied for aesthetic sport and weight-sensitive sport athletes, and relevant biological indicators will be searched. In the second year of this study, the effect of carbohydrates and proteins or specific nutrients as energy availability strategies on low energy availability animal physiological function, exercise performance and overall health status will be investigated. In the third year of this sudy, the effects of carbohydrate and protein supplementation with specific nutrients as energy availability strategies on athletes' physical function, athletic performance, and overall health status during high-relative energy-deficient training will be explored. It is hoped that through the successful implementation of this research project, the results can be applied to personalized dietary planning and ensure that minimizing adverse risk factors for athletes during critical periods, which is the most important key to maintaining good health, performing at their best in training and competition, and winning the highest honor for their country on the playing field.

Keywords: Energy availability, Relative energy deficiency in sport, Low energy availability risk factors, Carbohydrate availability, Protein availability

Eligibility Criteria:
Inclusion Criteria:

* In the past year, the daily training frequency is ≥4 times/week, and each time is at least 2 hours, and there are specific special trainers

Exclusion Criteria:

* smoke
Extracorporeal Shock Wave Therapy and Assessment Strategy Through a Novel Gait Analysis Tool for Post-stroke Spasticity

The aim of this study is to objectively evaluate the effectiveness of radial extracorporeal shock wave therapy (rESWT) and conventional physical therapy program on the gait pattern through a new gait analysis system which encompasses spatiotemporal and kinematic parameters and to correlate the findings with the clinical evaluation.

The aim of this observational study was to objectively evaluate the effects of radial extracorporeal shock wave therapy and conventional physical therapy program on the gait pattern, spatiotemporal variables (step length, step cycle time, stance foot flexion-extension, foot stance pronation-supination, and foot swing flexion-extension), and kinematic parameters (trunk flexion-extension, trunk lateral flexion, hip flexion-extension, knee flexion-extension, ankle flexion-extension) through a new gait analysis system and correlate the findings with clinical outcomes such as Modified Ashworth scale (MAS), passive range of motion (PROM), Clonus score, Visual Analogue Scale (VAS), Tinetti Assessment Tool, Functional Ambulation Categories (FAC).

The gait pattern of post-stroke patients before and after rESWT delivery and conventional rehabilitation program will be assessed clinically and also through an instrumented treadmill (Walker View) in terms of spatiotemporal and kinematic gait parameters.

Eligibility Criteria:
Inclusion Criteria:

* suffered from a hemorrhagic or ischemic stroke and they were in the subacute or chronic phase;
* had no history of previous stroke;
* had lower limb post- stroke spasticity and spasticity grade ≥1 on the Modified Ashworth Scale (MAS);
* pain intensity measured on Visual Analogue Scale (VAS) ≥1;
* ability to stand and walk unassisted for at least 30 seconds;
* adult patients (\>18 years old).

Exclusion Criteria:

* other neurological, musculoskeletal, orthopaedic, or cardiovascular conditions; -- severe cognitive impairment, severe aphasia or inability to understand or execute instructions;
* changes in antispastic medication and dose or changes in the analgesic medication;
* myopathy;
* severe spasticity grade;
* visual field disorders or hemineglect;
* anticoagulants or any contraindication to receive radial extracorporeal shock wave therapy (rESWT), or any contraindication to receive physical therapy sessions.
Using Capnography to Reduce Hypoxia During Pediatric Sedation

The investigators hypothesize that the addition of capnography during moderate sedation will improve recognition of hypoventilation and apnea. This will lead to an increased frequency of staff interventions such as verbal or physical stimulation for these events in order to improve ventilation which will in turn lead to a reduction in the frequency of oxygen desaturations. If capnography proves to be effective in creating earlier detection and intervention for hypoventilation and apnea during moderate sedation provided by non-anesthesiologists, this device can be used in a variety of clinical settings to enhance patient safety.


Eligibility Criteria:
Inclusion Criteria:

* Children 1-20 years old who require IV sedation in the Pediatric Emergency Department at Yale-New Haven Children's Hospital

Exclusion Criteria:

* Unable to tolerate nasal-oral cannula
* Conditions that effect end-tidal carbon dioxide measurement (active asthma, diabetic ketoacidosis, severe dehydration or trauma)
* Intubation
Validation of Romanian Version of Radner Reading Charts

Interventional, parallel groups, single center trial with a prospective design

The "Radner Reading Charts" have been developed on the basis of the concept of "sentence optotypes" for the standardized examination of reading acuity and reading speed. Print sizes are logarithmically scaled (LogRAD) to permit statistical analysis, and the results obtained can be compared to other logarithmically scaled vision systems (e.g., LogMAR). To guarantee accurate, reproducible and standardized measurements of reading acuity and reading speed at every viewing distance, "sentence optotypes" have been created to minimize the variations between the test items and to keep the geometric proportions as constant as possible at all distances. Through interdisciplinary cooperation, a series of test sentences were developed that are highly comparable in terms of the number of words (14 words), as well as the word length, number of syllables, position of words, lexical difficulty and syntactical complexity. The most similar sentences were statistically selected for the Radner Reading Charts.

Eligibility Criteria:
Inclusion Criteria:

* Men or women aged ≥18 years
* Visual acuity ≥ 20/20 Snellen in each eye
* Average daily reading time for students 5-7 hours and for non-students 0,5-2 hours
* Willingness to provide signed informed consent

Exclusion Criteria:

* Ocular pathologies that can influence the study results
* Alcohol ingestion
* Concomitant medication that can influence visual acuity