cyrilzakka/clinical-trials huggingface dataset:
Accuracy of Point-of-Care Measurement With the RapidPoint 500 Blood Gas Analyser

ICU patients are at high risk of ionic or metabolic disturbances during the course of their critical illness. Some of these disturbances might be life-threatening and require rapid response from physicians. Point-of-Care determination of electrolytes, glucose, hemoglobin and hematocrit ensures early detection (within 1 minute) of abnormal values and allows rapid and appropriate therapy. This technology has largely improved the quality of care in ICU. However, the accuracy of the measurement of those parameters had to be close enough to the reference method, usually perfomed in the central lab but time consuming. Recently, a novel generation of blood gas analyser has been released. Among them, the RapidPoint 500 is mounted with a 28-day cartridge which provides automatic calibrations and quality controls several times a day. Such a technology dramatically decreases the need for labs technical interventions. To date, there is no data reporting the accuracy of this device. Therefore, the investigators' aim is to compare the accuracy of the RapidPoint 500 with a reference measurement performed at the central laboratory (Beckman\&Coulter AU5800 for electrolytes and Beckman\&Coulter DXH for hemoglobin).


Eligibility Criteria:
Inclusion Criteria:

* Current stay in ICU
* Presence of an indwelling arterial catheter (radial or femoral)
* Prescription by physicians of a blood gas analysis and a laboratory analysis for the next morning

Exclusion Criteria:

* None
Pulmonary Arterial Hypertension Secondary to Idiopathic Pulmonary Fibrosis and Treatment With Bosentan

Pulmonary Arterial Hypertension (PAH) in the setting of Idiopathic Pulmonary Fibrosis(IPF)is a risk factor for morbidity and mortality in the peri-lung transplant(LT) setting. Currently there is no significant data to support the use of pulmonary vasodilators for PAH in the setting of interstitial lung disease such as IPF. The majority of IPF patients have PAH either at rest or during exercise. The study hypothesis is that bosentan may improve morbidity and mortality in the peri-LT setting in both IPF cohorts with either resting or exercise PAH.

The purpose of this study was to evaluate bosentan in the setting of exercise or resting pulmonary hypertension in patients with underlying pulmonary fibrosis.

Eligibility Criteria:
Inclusion Criteria:

* Idiopathic Pulmonary Fibrosis referred for lung transplantation
* Minimum 50 meter 6 minute walk distance
* No significant underlying liver disease

Exclusion Criteria:

* Significant liver disease or cirrhosis
* non ambulatory
* previous adverse reaction/allergy to Bosentan
BrUOG 351: PRE-OPERATIVE APBI USING NIBB

Partial breast irradiation is typically performed after surgical removal of the tumor. Partial breast irradiation allows for focused radiation to the area from which the cancer was removed, sparing breast tissue from the potential bad effects of radiation compared to radiating the whole breast, which was the standard of care for many years. This study is evaluating the use of partial breast irradiation with NIBB performed before surgery instead of after surgery.This should allow researchers to target the cancer even more accurately and result in less normal breast tissue receiving radiation which may cause less side effects and/or a better cosmetic outcome.

In this study partial breast treatment will be given with NIBB in 5 treatments over about 1 week. Surgical removal of the tumor will then be performed between 4-12 weeks following radiation treatment. Researchers believe that participant's risk of complications from surgery will not be higher after getting these radiation treatments than it would have been if participants had surgery first, but that is one of the things researchers are studying.


Eligibility Criteria:
Inclusion Criteria:

* Confirmed histological diagnosis of invasive breast carcinoma and/or DCIS (Invasive lobular carcinoma excluded);
* Age greater or equal to 60 years old;
* Life expectancy \> 6 months;
* Candidate for breast conserving surgery who intends to undergo breast conserving surgery as confirmed in writing by treating physician in consultation with surgeon
* Clinically lymph node negative (cN0) as confirmed in writing by patient's treating physician. If patient has suspicious lymphadenopathy on imaging it is required that patient undergo a biopsy to confirm cN0.
* Tumor size by imaging ≤ 2cm; (Tis or T1)
* Estrogen receptor positive if invasive disease (DCIS can be ER negative);
* Her2neu negative if invasive disease;
* Nuclear Grade 1 or 2 if invasive disease (DCIS can be Grade 3);
* ECOG performance status of 0-2 (Appendix 1);
* Informed consent signed.

Exclusion Criteria:

* Excisional biopsy or ipsilateral breast surgery within 6 months;
* Invasive lobular histology;
* Definitive LVSI on biopsy;
* Suspicious imaging findings suggesting multi-focal or multi-centric disease, unless biopsy proven benign;
* Paget's disease of the nipple
* Distant metastases;
* Known BRCA 1/2 Mutation
* Active lupus or scleroderma,;
* Psychiatric or addictive disorder that would preclude attending follow-up;
* Neoadjuvant chemotherapy or endocrine therapy (adjuvant therapy is permitted);
* Breast Implants;
* Tumor not well visualized on AccuBoost imaging;
* Breast separation with compression \> 8cm at time of simulation.
Pain Evaluation in Rheumatoid Arthritis

Rheumatoid Arthritis (RA) is an inflammatory chronic rheumatism where the pain remains the priority domain of improvement for the patients instead a good control of the inflammatory disease by treatments, even biotherapeutics .

Some studies show that less than 50 % of the patients is satisfied by the care of the pain, whereas the criteria of evaluation of the RA improve under treatment. The chronic pain, is a complex and multifactorial subjective phenomenon requiring a multidimensional evaluation, while the current criteria of follow-up of the RA (DAS28, ACR criteria) investigate the pain in a single dimension that is the pain intensity.

So, the investigators do not arrange explanation for this observed dichotomy between the improvement of the clinical and biological inflammatory criteria of the RA and on the other hand the persistence of pain.

On the other hand, the interleukin (IL)-6, IL-17 and IL-33 are cytokines occurring in the physiopathology of RA and probably in the pain processing according to recent data of the literature.

The aim of this study is:

* to assess the multidimensional origin of the pain in RA patients by means of questionnaires
* to look for a possible correlation between the serum level of cytokines and pain.


Eligibility Criteria:
Inclusion Criteria:

* Adults with RA treated with DMARDs and/or biotherapy,
* Capable of providing written consent

Exclusion Criteria:

* Patients affected by a painful disease other one than RA,
* Fibromyalgia,
* A malignancy disease,
* An hemopathy,
* Psychiatric disorders or dementia and
* Acute infectious diseases and
* Receive or had received anti-IL6 therapy
Evaluation of Two Pharmacological Protocols for Pre-emptive Analgesia in Impacted Third Molar Surgery

The main aim of the study is to investigate the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.

The surgery of third molar is usually associated with important post-surgical sequelae. The damage caused to tissue and bone may result in considerable pain, edema and trismus. The symptoms start gradually, peaking in 2 days after the extraction. The use of medications such as dexamethasone and diclofenac associated to codeine may support the prevention of post-surgical pain. This clinical trial aim compare the the pre-emptive effect of dexamethasone and diclofenac associated to codeine to prevent the pain, edema and limited mouth opening at the extraction of third molar.

Eligibility Criteria:
Inclusion Criteria:

* Patients with indication of asymptomatic bilateral extractions of lower third molars;
* Aged 18 years or older;
* Have a good health and no disease;

Exclusion Criteria:

* Patients with history of any medication treatment within 15 days before the beginning of the research, history of allergy to the drugs, substances or materials used in this study, pregnancy or lactation.
Mental Stress and Myocardial Ischemia After MI: Sex Differences, Mechanisms and Prognosis

The purpose of this study is to look at the link between emotional stress and heart disease in men and women. Taking part in this study involves one clinic visit, one week of at home monitoring, and follow up phone calls every 6 months for 3 years.

In the U.S. and globally, coronary heart disease (CHD) is the number one killer of women. Despite scientific advances, it is unclear whether the pathophysiology of CHD differs between women and men. The study of CHD in women has historically been centered on older women, however, women with early onset CHD are informative for the study of early risk factors and pathophysiology. Furthermore, young women with a myocardial infarction (MI) have emerged as a group in need of special study as this group has higher mortality compared with men of similar age despite less severe disease. These disparities remain unexplained and suggest sex differences in the pathophysiology, risk factors and prognostic factors of acute MI.

The psychosocial sphere is a largely neglected area for CHD prevention in women. Social and emotional exposures mostly beginning early in life (depression, early life adversities, poverty and posttraumatic stress symptoms) are more common in younger women with MI compared with men and community controls. In addition to being more prevalent, it is possible that emotional stress is a stronger risk factor in young women than other groups. A significant challenge, however, is to measure stress in a valid way.

Building on previous work, the current project will clarify sex differences in pathways of risk linking emotional stress to mental stress-induced myocardial ischemia (MSI) and cardiovascular outcomes in young post-MI patients. Within 8 months of MI, 310 patients ≤60 years of age (at the time of the MI), 50% women, will be tested in the lab with a stress challenge to asses MSI using an established protocol with myocardial perfusion imaging. Participants will be monitored at home for 1 week, and then followed for clinical events for 3 years.

Eligibility Criteria:
Inclusion Criteria:

* History of documented MI within the past 8 months
* Age ≤60 at the time of MI

Exclusion Criteria:

* History of unstable angina, MI, or decompensated heart failure in the past month
* Patients deemed to be unsafe to hold anti-ischemic medications before testing (it is standard protocol to hold these meds before imaging studies)
* Systolic blood pressure (SBP) \>180 mm Hg or diastolic blood pressure (DBP) \>110 mm Hg on the day of the test
* Alcohol or substance abuse (past year), or severe psychiatric disorder other than major depression
* Other serious medical disorders that may interfere with the study results
* Postmenopausal hormone therapy (past 3 months)
* Current psychotropic medications (past month) except anti-depressants
* Pregnancy or breastfeeding (all women will receive a pregnancy test)
* Severe aortic stenosis
* Weight ≥ 360 pounds and/or body mass index (BMI) of 40 or greater (weight limit of the SPECT imaging table)
Targeted PCR and Acute Endophthalmitis

Endophthalmitis is a serious eye infection of exogenous origin (post-operational, post-traumatic) or endogenous origin (metastatic). This is a diagnostic and therapeutic emergency.

Each patient suffering from endophthalmitis must have immediately an ocular sampling, an intra ocular injection of antibiotics and a systemic antibiotic cover.

The etiological treatment will be adapted according to the infectious agent.

The main goal of this prospective multi-centre trial is to improve the sensitivity and rapidity of the infectious agent's identification involved in endophthalmitis cases, particularly virulent species (like Staphylococcus aureus, Streptococcus pneumoniae...) from ocular samples with the help of real-time PCR.

This will help the ophthalmologist to be more efficient in accordance with the kind of the bacteria.

Data will also enable to compare both PCR techniques used in this study. The secondary goal of the prospective study is to characterize the resistance of bacterial's species found during acute endophthalmitis with the antibiogram and by the study of resistance genes, to enable to correlate the resistance in vitro with the therapeutic response in vivo and get precious epidemiological data to adapt prophylactic antibiotic.

Eligibility Criteria:
Inclusion Criteria:

* Subjects affiliated to the social security system
* Signed informed consent documentation
* Patients over 18 years
* Male or female person
* Patients hospitalized for diagnostic and therapeutic evaluation of a post-operative acute endophthalmitis, or within the context of a scheduled surgery with sampling of aqueous humour.
* Has given his or her consent, having been provided with detailed informations regarding to intraocular sampling.

Exclusion Criteria:

* antibiotherapy via intravenous (\< 8 days) for patients NON suffering from endophthalmitis (control group)
* Patient's participation to the study refused
* Patients under 18 years
* Patients adults under guardianship or curatorship, or unable to express his/her consent.
* Pregnant women
* Breastfeeding women
* Person deprived of liberty
Diagnostic Value of D-dimer/Fibrinogen Ratio in Patients With Acute Aortic Dissection

Acute aortic dissection is rare but potentially life-threatening disease with an incidence of 5-30 cases per million, annually. Therefore prompt diagnosis is crucial. D-dimer values have been shown to be useful in the diagnosis of acute aortic dissection. Fibrinogen levels have been shown to be low, normal or high in individuals with acute aortic dissection. This study aims to investigate whether D-dimer/fibrinogen ratio can be valuable for diagnosis of acute aortic dissection.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of acute aortic dissection
* Diagnosis of acute pulmonary embolism
* Diagnosis of non-cardiac chest pain

Exclusion Criteria:

* Any etiology of chest pain other than acute aortic dissection, acute pulmonary embolism, or non-cardiac chest pain
* Participants who do not give consent for enrollment
Evaluation of Tissue Glue on PICC and Midline Catheters Insertion Sites

The study will evaluate a new type of cyanoacrylate tissue glue Secure PortIV on the insertion site of the PICC (Peripherally inserted central catheter) or Midline catheters. Fixation of the catheter with the tissue glue should prevent incidents of mechanical and infective phlebitis as well as external migrations of the catheters.

In the study, 125 subjects will receive the new tissue glue Secure PortIV and 125 subjects will be provided standard care. The tissue glue will be applied immediately after insertion. Evaluation and re-evaluation of the site will be done on the first and seventh day after insertion using VIP and CLISA (Central-Line Insertion Site Assessment) scale and on the seventh day with taking a swab from the insertion site; the external length will be measured on the first and the seventh day, in order to observe the migration or not.

The goal of the study is to evaluate the benefits of the cyanoacrylate tissue glue Secure PortIV in the prevention of mechanical and infective phlebitis and external migration of the catheter.

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age
* need of long-term venous access
* consent with participation in the study

Exclusion Criteria:

* pediatric population
* not signing the informed consent form
Acellular Dermal Matrix in Primary Palatoplasty

The goal of the present study is to definitely determine whether the use of acellular dermal matrix (ADM) during primary cleft palate repair decreases the rate of fistula formation. Although individual studies have described promising advantages to its use in cleft palate surgery, no consensus currently exists. Without concrete evidence, one must question the whether the increased cost, time and potential patient risk (human derived tissue) to patients justifies its use in primary cleft palate repair.

There has been a change in the standard practice at the Montreal Children's Hospital where the senior author has shifted from selected application of ADM in certain cases to routine use of ADM in all cleft palate cases. This study is an observational study comparing a prospective cohort group receiving ADM routinely to a retrospective historical cohort group without routine use of ADM.

Objectives of the study:

Primary objectives:

The primary objective of this study is to determine whether routine use of ADM would lower the incidence of palatal fistula in patients undergoing primary cleft palate repair.

Secondary objectives:

1. Incidence of wound dehiscence
2. Incidence of wound infection
3. Hospital length of stay

Eligibility Criteria:
Inclusion Criteria:

* Children diagnosed as having Veau class II to IV cleft palates undergoing Furlow palatoplasty with ADM between the ages of 3 months and 3 years will be included in this study.

Exclusion Criteria:

* Selection will be based on the parent's willingness to allow their child to participate in the study.
* Children with diagnosed craniofacial syndromes will be excluded from the study due their higher than usual incidence of palatal fistulas.
* Children with known wound healing defects, such as Ehler Danlos syndrome, Pseudoxanthoma Elasticum, will be excluded from the study due to their inherent collagen defects and consequently on the incidence of palatal fistulas.
* Children with Veau class I cleft palates and those who will need/needed any surgical technique other then Furlow palatoplasty will be excluded from the study.
Pharmacokinetics of Dihydroartemisinin-Piperaquine in the Treatment of Uncomplicated Malaria in Children in Burkina Faso

This will be an open-label trial in Burkina Faso assessing the pharmacokinetics of the antimalarial combination of dihydroartemisinin/piperaquine (DP, Duocotexcin) in children. Dihydroartemisinin-piperaquine is a promising candidate for first-line therapy of malaria. We hypothesize that the disposition and pharmacokinetics of DP will be altered in children, and this will alter the efficacy and/or toxicity of DP. We will test this hypothesis in this open-label trial in Burkina Faso. The target population includes residents, aged 6 months to 10 years in Bobo-Dioulasso. Children who present to the study clinics with symptoms suggestive of malaria will be screened with a thick blood smear. Subjects who meet selection criteria of treatment efficacy will be treated and followed up for 42 days. Pharmacokinetic sampling for DP will occur on selected follow-up days.


Eligibility Criteria:
Inclusion Criteria:

1. Positive screening thick blood smear
2. Fever (\> 37.5ºC axillary) or history of fever in the previous 24 hours
3. Age ≥ 6 months to 10 years
4. Weight \> 5 kg
5. Absence of any history of serious side effects to study medications
6. No evidence of a concomitant febrile illness in addition to malaria
7. No history of antimalarial use in the previous two weeks
8. P. falciparum mono-infection
9. Parasite density 2000-200,000/ul
10. Provision of informed consent and ability to participate in 42-day follow-up

Exclusion Criteria:

1. Danger signs or evidence of severe malaria
2. Hemoglobin levels \< 5.0 gm/dL
Posterolateral Surgical Approach Compared With Modified Lateral Approach

It has been reported that the operative approaches have an effect on clinical outcome in total hip arthroplasty. The purpose of this prospective study was to compare clinical and radiological outcomes between anterolateral approach and posterolateral approach in total hip arthroplasty.

Total hip arthroplasty is one of the most successful orthopaedic procedures for relieving pain and improving quality of life. But dislocation remains the leading early complication after total hip arthroplasty with a reported frequency between 0.4% and 11%. There are several risk factors of dislocation after total hip arthroplasty including patients, implants and surgical approaches. Among lots of risk factors, surgical approach has been debated as one of the important key factor influencing dislocation and abductor function. Direct lateral or posterolateral surgical approach is most commonly used in the total hip arthroplasty. The modified lateral approaches generally are thought to have lower dislocation rates and allow excellent acetabular exposure although limping is increased. The posterolateral approach may allow maintenance of abductor strength but it generally results in a higher dislocation rate. However, there are several reports that the posterolateral approach with capsular repair might be reduced dislocation rate.

We hypothesize the dislocation rate for the posterolateral approach with capsular repair is similar to modified lateral approaches for total hip arthroplasty. A prospective, randomized-controlled study was to examine the null hypothesis that the dislocation rate for the posterior approach with capsular repair was similar to modified lateral approaches for total hip arthroplasty at up to 2 year followup. We attempted to determine whether there was a difference in surgical parameters, component positioning, and clinical results of the modified lateral approach compared with the posterolateral approach.

Eligibility Criteria:
Inclusion Criteria:

* osteonecrosis
* primary or secondary osteoarthritis of the hips
* femoral neck fracture.

Exclusion Criteria:

* Patients with previous hemi- or total hip arthroplasty
* highly dislocated or severe ankylosed hip
* patients who are considered potentially unreliable or who may not reliably attend study visits
tACS Treatment for Cognitive Impairments in Methamphetamine Addicts

1. To evaluate the cognitive function of methamphetamine Patients.
2. Investigate the pathological mechanism of methamphetamine patients from the aspects of EEG and biology;
3. The investigators investigated the effects of transcranial alternating current stimulation (tACS) on cognitive impairments in methamphetamine patients


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis diagnosis of methamphetamine use disorder according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5)
* None of participants had mixed use of other drugs
* None of participants had physical disability
* None of participants had acute physical or mental illness, hallucinations, acute withdrawal symptoms
* None of participants were receiving any medical treatment

Exclusion Criteria:

* Intracranial hypertension
* Cranial defects
* Tumors
* Serious physical illnesses (e.g., cardiovascular, liver, kidney, gastrointestinal disorders)
* Infectious diseases
* Immune system disorders
QUELIMMUNE (SCD-PED) PediAtric SurVeillance REgistry

QUELIMMUNE is FDA-approved under an HDE for the treatment of pediatric patients (weight ≥10kg and age ≤22 years) with AKI due to sepsis or a septic condition on antibiotic therapy and requiring RRT.

The purpose of this surveillance registry is to prospectively collect safety data among all patients treated with QUELIMMUNE under the HDE. More specifically, we intend on comparing the incidence of new (secondary) blood stream infections in the first 28 days after SCD-PED initiation to a comparator group of matched CKRT patients with sepsis who did not receive treatment with QUELIMMUNE


Eligibility Criteria:
Inclusion Criteria:

* All patients initiated on QUELIMMUNE therapy under the HDE-approved indication

Exclusion Criteria:

* Weight ≤10kg
* Age \>22 years
* Known allergy to any components of QUELIMMUNE