cyrilzakka/clinical-trials huggingface dataset:
Comparison of Pre-oxygenation of NIV and HFNC Therapy for Intubation of ICU Patients With Acute Respiratory Failure

The aim of the study is to evaluate the incidence of severe hypoxemia episodes during the intubation procedure with two methods of pre-oxygenation:

1. NIV (Non Invasive Ventilation)
2. HFNC (High-flow nasal canula oxygen therapy)

Design:

Clinical randomized, open, multicenter, comparative trial, with parallel groups aimed at evaluating a medical device.

Selection of patients admitted to the ICU for acute respiratory failure, requiring endotracheal intubation.

Randomized study, inclusion in two groups: NIV or HFNC.

Experimental group:

NHFC group, preoxygenation by NHFC: oxygen flow rate of 60 L / min and 100% FiO2.

Control group:

NIV group, preoxygenation by NIV: pressure support set for an exhaled tidal volume of 6-8 ml / kg of ideal body weight, PEEP of 5 cm H2O and FiO2 at 100%.

Duration of participation of each patient: 28 days

Eligibility Criteria:
Main inclusion Criteria:

* acute hypoxemic respiratory failure requiring endotracheal intubation

Main exclusion Criteria:

* coma
* NIV contraindication
Forensic Dental Age Estimation : Validation of Computed Tomography for Third Molar Demirjian's Staging

Age can be estimated in different ways by using skeletal age and dental age. Currently, bone age is determine thanks to the wrist x-rayed, and the dental age using variation in mineralization (Demirjian's score) on the dental panoramic (Mincer 1993).

More recently, reviews indicate the Computed tomography (CT) scan of the medial clavicular epiphysics can contribute to improve the accuracy of individual's age estimation (Houpert, 2016).

Furthermore, with the recent advances, the very low dose CT scan acquisitions can be perform with sufficient quality for the teeth analysis.

The goal of this study is to validate the use of dental CT for Demirjdian's staging method.


Eligibility Criteria:
Inclusion criteria:

* Patient aged between 0 and 25 years old
* Complete dental panoramic
* CT scan including mandible and maxilla
* Maximum of 2 months between CT scan and dental panoramic
* Medical imaging available on the PACS

Exclusion criteria:

* Medical imaging missing on the PACS
* Patient refuses to participate
The Effect of Preoperative Anxiety, on Gastric Antrum Size in Women Undergoing in Vitro Fertilization

Pulmonary aspiration is one of the most serious risks of general anesthesia and has been reported to occur in as many as 1 in 4000 cases of general anesthesia. Gastric ultrasound is an emerging point-of-care tool that provides bedside information on gastric content and volume.

There have been a few factors which are thought to increase gastric size. Delayed gastric emptying such as caused by gastroparesis in Diabetes Mellitus is an example. Certain surgeries also cause gastroparesis. Other preoperative factors including pain, preoperative anxiety, and blood levels of estradiol or progesterone are less well studied.

Women will be recruited before undergoing the procedure.

Upon signed informed consent, women will be asked to rank their anxiety level on a scale of 0-10 (Verbal Numeric Anxiety Score). This scale has been used for previous studies to assess anxiety (Orbach-Zinger, Danon)

In the operating room, a gastric ultrasound will be performed in the supine position and the antral cross sectional area will be measured. This study is purely observational, the gastric ultrasound assessment is non-invasive and will not cause any adverse effects or discomfort to the patient. Participation in the study will not affect clinical management in any way.

Each one of the ultrasound assessments will be performed by one of the study's' investigators.

Anesthesia will be induced in standard procedure and positive pressure will be instituted according to the standard protocol accepted in our hospital.

At the end of the procedure, the gastric ultrasound circumference will be measured again.

Eligibility Criteria:
Inclusion Criteria:

Woman aged 18 and above undergoing general anesthesia for oocyte retrieval during in vitro fertilization with the ability to sign an informed consent.

Exclusion Criteria:

1. Women with BMI \>40
2. Women with diabetes
3. Women who have previously undergone gastric surgery
4. Women with language barriers.
Nitrate Supplementation; Source

The main aim of the current study will be to compare the effects of ingesting different nitrate-rich sources on plasma nitrite concentrations.

Oral ingestion of nitrate (NO3-) has been shown to increase plasma nitrate and nitrite levels. Significant lowering of pulmonary oxygen uptake during exercise, as well as significantly lower blood pressure values at rest have been observed after supplementation with nitrate. However, no study has yet described a direct comparison between different nitrate-rich beverages with respect to the bioavailability of nitrate/nitrite and the possible hemodynamic effects. Based on the gaps in current literature, our main goal will therefore be to gain further insight into the effects of nitrate supplementation with different sources on plasma nitrite levels.

Eligibility Criteria:
Inclusion Criteria:

* 18.5 \< BMI \< 30 kg/m2
* Engagement in regular physical activity ( \> 1 h a week)

Exclusion Criteria:

* Use of medication
* Smoking
* Currently supplementing diet with nitrate
* Lactose intolerance
Brain Mechanisms of Pharmacotherapy in Opioid Use Disorder

This study will investigate the mechanisms of cognitive-behavioral response to medications used for relapse prevention in opioid use disorder (opioid addiction, OUD), through investigation of the neural circuits underlying key cognition functions. The study will use previously validated cognitive probes, functional Magnetic Resonance Imaging (fMRI), and novel extended-release injectable preparations of opioid partial agonist buprenorphine and antagonist naltrexone, in OUD patients to explain the individual heterogeneity of OUD treatment response.

This proposal seeks to identify the neural circuits underlying the cognitive effects of medication assisted therapy (MAT) for OUD. The study will examine the neurocognitive effects of MAT by comparing two preparations with different pharmacodynamic properties (extended release buprenorphine and naltrexone, XRBUP, XRNTX) in three key domains (incentive salience, executive functioning, and emotion processing) using task functional Magnetic Resonance Imaging (MRI). In the 1st phase of the study, forty treatment-seeking OUD patients will be randomized to XRNTX or XRBUP groups after detoxification. Participants will undergo medication induction followed by monthly injections and urine toxicology monitoring for 120 days. Neuroimaging will follow completion of detoxification (pre-treatment) and 15 days after the second injection (on-treatment). The second study phase will extend the paradigm to an independent sample of 160 additional participants and test the explanatory value of MAT-induced changes in the neuroimaging signal in the classification of OUD treatment outcomes.

Eligibility Criteria:
Inclusion Criteria:

1. Males and Females
2. 18-65 Years old
3. OUD by DSM5 Criteria, confirmed by history and physical examination including urine toxicology, medical records and self-report
4. Opioids are the drug of choice
5. Interested in injectable extended release agonist or antagonist treatment
6. Have a stable address, working command of English language, and telephone access.
7. Women of childbearing age must use an effective contraceptive

Exclusion Criteria:

1. Psychiatric Co-morbidities:

   1. Lifetime diagnoses of any psychotic disorder, e.g. schizophrenia, schizoaffective disorder, bipolar disorder type 1.
   2. Psychiatric Co-morbidities: Psychiatric disorders requiring current medication treatment, e.g. moderate to severe depression. Mild to moderate Depressive and Anxiety disorders and Attention Deficit Hyperactivity Disorder that do not require prescription stimulants and DSM5 Cluster B and C personality disorders are also allowed.
   3. Polysubstance users whose drug of choice is not opioids.
2. Contraindications for XRNTX or XRBUP e.g. active liver disease.
3. Medical and surgical conditions such as malignancy that may affect patients' ability to receive XRNTX or XRBUP treatment because it may interfere with opioid analgesia
4. Contraindications for MRI, e.g. claustrophobia, indwelling foreign magnetic agents.
This Study is An Open-Label Trial Of Pregabalin In Patients With Fibromyalgia

The main purpose of this protocol is to evaluate the long-term safety of pregabalin in patients who participated in the previous fibromyalgia Study A0081100 and who wish to receive open-label pregabalin therapy.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have met the inclusion criteria for the preceding fibromyalgia Protocol A0081100, and must have received pregabalin/placebo under double-blind conditions.

Exclusion Criteria:

* Patients may not participate in the study if they experienced a serious adverse event during the previous fibromyalgia Study A0081100 which was determined to be related to the study medication by the investigator or the sponsor.
S-ICD French Cohort Study (HONEST)

Implantable cardioverter-defibrillators have been proven to be effective in the prevention of sudden cardiac death in high-risk patients. However, it is well acknowledged that such a strategy could be optimised, especially through new technologies/devices. Data on the entirely sub-cutaneous implantable cardioverter defibrillator (S-ICD) published so far come from high-volume centers and/or selected populations. The HONEST Cohort -taking the opportunity of a unique scenario with a single manufacturer and remote monitoring system available- aims to collect retrospectively baseline information as well as follow-up of all patients implanted with an S-ICD in France since the first implant in October 13, 2012 until December 31, 2019. An extended prospective yearly follow-up will be carried out since January 1, 2020 until December 31, 2024.


Eligibility Criteria:
Inclusion Criteria:

* All patients who require S-ICD implantation (new or battery replacement)

Exclusion Criteria:

* Refusal of consent
Low Dose Naltrexone for Treatment of Pain in Patients With Fibromyalgia - Effect Via a Central Mechanism?

This study evaluates the effect and mechanism of low dose naltrexone for treatment of pain in patients with fibromyalgia. It s a randomised, double-blinded, placebo-controlled, cross-over study.

The study takes place at The Multidisciplinary Pain Center in Grindsted.

Fibromyalgia syndrome is a prevalent musculoskeletal disorder characterized by pain, profound fatigue, sleep disorder, mood disturbance etc. The prevalence is estimated to be 2-8%.

Treatment of pain in patients with fibromyalgia is often based on opioids. However, opioids may lead to tolerance, addiction and hyperalgesia and alternative treatments are therefore warranted.

Low dose naltrexone (3-5mg) (LDN) has shown promising results in the treatment of pain in patients with fibromyalgia, but there is a need for further research.

At the typical dose of naltrexone, 50 mg, it is an opioid antagonist. However LDN demonstrates analgesic and anti-inflammatory effects, possibly involving an antagonism of microglia in the CNS.

The investigators hypothesize, that LDN has a better pain relieving effect than placebo in in patients with fibromyalgia (FM). The investigators also hypothesize that LDN has a better effect upon experimentally induced pain in FM-patients, compared to placebo. A tentative mechanism is a central facilitation of the endogenous pain inbitory system.

Eligibility Criteria:
Patients diagnosed with fibromyalgia based on the criteria of American College of Rheumatology.

Inclusion Criteria:

* Widespread pain in patients with fibromyalgia (based on the above criteria)
* Enrolled as a patient in one of the multidisciplinary pain clinics involved in the project
* Inflammatory rheumatic disease (peripheral inflammation, including arthritis), must be excluded
* Women must be treated with a contraceptive measure, if not menopausal

Exclusion Criteria:

* Cancer
* Treatment with opioids (other analgesic treatments in stabile dose 14 days prior to study start are allowed)
* Change in stabile treatment (p.n. paracetamol is allowed, but must be registered)
* Pregnant/breastfeeding
* Does not speak/understand Danish
* Allergy to the ingredient
* Severe liver impairment
* Severe kidney impairment
* Acute hepatitis
Study of Microwave Spherical Ablation and Traditional Microwave Ablation in Single Hepatocellular Carcinoma ≤5cm

Comparison of the progression-free survival, overall survival, local progression rates, complete ablation rates and the complications rate of MSA and traditional MWA in the treatment of single hepatocellular carcinoma with a diameter of ≤5cm.

HCC is a serious threat to the health of people，Early treatment of HCC results in a good prognosis for patients. Microwave ablation (MWA) is an important method for the treatment of early HCC. The traditional MWA technology has a long diameter of the ablation foci which is much larger than the transverse diameter, so in order to obtain a sufficient transverse diameter, the long diameter is often too large beyond the tumor boundary. That will cause too much normal liver tissue is unnecessarily damaged, especially for patients with severe liver cirrhosis or patients with liver cirrhosis who have undergone liver resection. In addition, it is easy to cause damage to adjacent vital tissues and organs. Changes in tissue properties during ablation affect the stability of the microwave field, resulting in unpredictable ablation shapes, which may cause omissions during tumor ablation, especially in multiple overlapping ablation, resulting in incomplete ablation, or increasing the risk of local tumor progression after treatment. Microwave spherical ablation (MSA) technology is a new MWA technology. With the help of temperature control technology, field control technology and wave control technology, a single needle can produce predictable spherical ablation lesions. Theoretically, MSA can improve the controllability of the ablation foci, which is suitable for the purpose of conformal ablation of large tumors in clinical practice, thereby minimizing the damage of local thermal ablation to liver tissue and adjacent important organs. However, there are few reports on the comparison of the therapeutic effect of MSA and traditional MWA. This study intends to conduct a prospective randomized controlled study based on the two mature microwave treatment methods of MSA and traditional MWA ablation to explore the effectiveness and safety of MSA in clinical application, providing evidence-based medical evidence for the clinical application of MSA.

Eligibility Criteria:
Inclusion Criteria:

1. Patient has high risk factors for HCC and was first diagnosed of HCC by by contrast-enhanced imaging (CECT/CEMRI/CEUS) and/or pathology ;
2. Age range 18 to 75 years old;
3. Single lesion with tumor diameter ≤5cm;
4. Patient refuses surgery and determines to undergo microwave ablation
5. Liver function Child Pugh A or B;
6. No extrahepatic metastasis or portal invasion;
7. Patient signs the informed consent.

Exclusion Criteria:

1. The lesion has received treatment, including local ablation therapy and TACE therapy, etc;
2. With portal vein invasion or extrahepatic metastases;
3. Patient is with severe cardiopulmonary insufficiency.
4. Patient is a pregnant or breastfeeding women.
5. Patient is considered to be unsuitable to participate in the study
Determining Patterns In Trial Experiences of Recurrent Prostate Cancer Patients

Clinical studies, with a dedicated focus on recurrent prostate cancer, play a pivotal role in evaluating the safety and effectiveness of novel treatments for this condition.

These trials serve as essential tools to determine whether new medications outperform traditional therapies, providing substantial evidence to endorse their broader utilization.

It will also try to analyze data from the perspective of different demographic groups to check for recurring trends which might yield insights for the sake of future patients with recurrent prostate cancer.


Eligibility Criteria:
Inclusion Criteria:

* Patient is at least 18 years of age
* Diagnosis of recurrent prostate cancer
* Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

* Enrolled in another research study
* Patients with psychiatric illness/social situations that would limit compliance with study requirements
* Inability to provide written informed consent
Exercise Response on Dose Curve Among Class I Obese Young Adult Population

The study is aimed to determine impact of dynamic resistance exercise training on Body Fat percentage of class-I Obese population and to quantify the dose of exercise program using a probit regression curve

Methodology

A sample size of 34 participants 17 male and 17 female of aged between 20-40 years with class-I obesity were selected and recruited in this study. All the participants were initially screened using a physical activity and readiness questionnaire to determine if they are fit to perform exercises afterwards intervention based on dynamic exercises were given to the patient for 12 weeks based on the guidelines of American College of Sports Medicine and the quantification of exercises was done using a Frequency, Intensity, Time and Type (FITT) protocol. The training session was based on Warm up 5 to 10 minutes followed by conditioning phase of 20 minutes and a cool down phase of 5 to 10 minutes. The detailed description of each of the phase is as under:

Warm up Phase Dynamic light aerobic warm up exercises were performed by the participants for 5 to 10 minutes before the start of the conditioning. Two different exercises that were performed included i) High Knee in which the knees will be lifted as high as possible in such a manner that both feet should be at one time be above the ground ii) Jumping Jack Exercise in which a simultaneous movement of upper and lower limb will be performed in a manner that every time during a jump the arms were thrusted over the head while the foot moved out to the side and than returning back to the original position 10 repetitions of both the exercises were performed.

Dynamic Resistance Exercise Modified Wingate protocol that incorporates 20 minutes of training on a cycle ergometer; included one minute of cycling with resistance to be performed at 85% to 90% of Maximal Heart Rate (MHR) followed by one minute of cycling with no resistance. The protocol will be performed for 10 times for a duration of 20 minute of workout.

Cool Down The process of cool down last for 5-10 minutes. During this low intensity, long hold stretching were performed of lower limb and upper limb that included shoulder, calf and hamstring stretch

Eligibility Criteria:
Inclusion Criteria:

* • Class I obese population BMI 30 -39.9

  * Young adults of age 20-40 years
  * Male and female population

Exclusion Criteria:

* • Recent surgery that limits participation in exercise program

  * Known Cardia Disease
  * Any comorbidity that limits participation in training program
Study of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in Patients With Rheumatoid Arthritis

This study is intended to evaluate the efficacy and safety of Iguratimod Plus Methotrexate Compared to Leflunomid Plus Methotrexate in patients with active Rheumatoid Arthritis (RA).


Eligibility Criteria:
Inclusion Criteria:

* Subjects with a diagnosis of RA according to the diagnostic criteria of the American College of Rheumatology (ACR) (revised in 1987)
* Rheumatoid Arthritis for more than 3 months from the time of the initial diagnosis
* Functional Class II-III
* Subjects have active RA at the time of screening
* Subjects with inadequate response to biologics should have a washout period before the initiation of study. For etanercept, washout period should be 2-week, and 8-week for infliximab and adalimumab.
* For firstly diagnostic RA patients, the disease activity should be moderate to severe, with DAS28\>3.2
* Must have at least 4 tender joints (66 join count) and 8 swollen joints( 68 join count) at screening and baseline
* Has a C-reactive protein ≥ 10 mg/L(or 1.0 mg/dL) OR Erythrocyte Sedimentation Rate (ESR) ≥ 28 mm/hr
* Must have a negative Pregnancy test and use adequate method of contraception throughout the trial
* Written informed consent

Exclusion Criteria:

* Preceding treatment with DMARDs, immunosuppressants (cyclophosphamide, cyclosporine, azathioprine, etc.), or Tripterygium within 4 weeks prior to study entry
* Subjects have been treated with iguratimod or leflunomide combined with MTX before screening.
* Subjects combined with other autoimmune disease, such as systemic lupus erythematosus (SLE), mixed connective tissue disease (MCTD), scleriasis and polymyositis, except for Sjögren syndrome.
* Chest x-ray abnormalities, such as tuberculosis, interstitial pulmonary fibrosis, etc.
* ALT \>1.5×ULN, AST \>1.5×ULN, Cr \>135umol/L, total bilirubin\>1.5×ULN
* WBC\<4×109/L，HGB\<85g/L，PLT\<100×109/L
* Subjects with serious cardiovascular, renal, hematologic, endocrine diseases or malignant
* Women of Pregnant or breastfeeding, and male or female with recent plan to conception
* Subjects with immunodeficiency, uncontrolled infection and active gastrointestinal disease
* Allergic to any of the study drugs
* History of alcoholism
* Subjects with mental illness
* Subjects receiving live vaccines recently
* Subjects participating in other clinical study within 3 months prior to study entry
A Study to Assess Drug Interaction of ASP015K and Midazolam

The objective of the study is to characterize the effect of multiple doses of ASP015K on the pharmacokinetics of a single dose of midazolam.


Eligibility Criteria:
Inclusion Criteria:

* Subject weighing at least 45kg and BMI of 18-32 kg/m2, inclusive
* If female, subject is at least 2 years post menopausal or is surgically sterile per documentation provided by a third party medical professional and the subject is not pregnant as documented by a negative serum pregnancy test
* If male, subject agrees to sexual abstinence, is surgically sterile, or is using a medically acceptable method to prevent pregnancy during the study period

Exclusion Criteria:

* History of any clinically significant disorder, disease or malignancy excluding non-melanoma skin cancer
* Recent history (within 6 months) of drug or alcohol abuse or positive urine screen for drugs of abuse/illegal drugs
* Treatment with prescription drugs or complementary and alternative medicines (CAM) within 14 days prior to study drug administration, or over the counter medication within 1 week prior to study drug administration
* A symptomatic, viral, bacterial or fungal infection within 1 week prior to clinic check-in
* Positive test for hepatitis C antibody, or positive test for hepatitis B surface antigen (HBsAg)
* History of the human immunodeficiency virus (HIV) antibody
* Positive tuberculosis (TB) skin test or Quantiferon Gold test
* Vaccinated within the last 30 days prior to study drug administration
* Received an experimental agent within 30 days or five half-lives, whichever is longer, prior to study drug administration
* Any significant blood loss, donated one unit (450 mL) of blood or more, or received a transfusion of any blood or blood products within 60 days or donated plasma within 7 days prior to clinic admission
* Absolute neutrophil count (ANC) \<2500 cells/mm3