cyrilzakka/clinical-trials huggingface dataset:
Morphine In Acute Myocardial Infarction

The purpose of this study is to determine whether intracoronary injection of morphine chlorhydrate is effective to limit ischemia-reperfusion lesion during percutaneous coronary angioplasty in patients with acute myocardial infarction (AMI).


Eligibility Criteria:
Inclusion Criteria:

1. Acute Myocardial Infarction less than 6 hours defined by

   1. prolonged chest pain (\>15 min)
   2. in association with

      * ST elevation 1mm or more in two contiguous leads
      * or occurence of Q wave in three contiguous leads
      * or occurence of left bundle branch block
2. Culprit lesion eligible for percutaneous coronary intervention (PCI)
3. TIMI flow 0 before PCI

Exclusion Criteria:

1. Fibrinolysis
2. Allergy to morphine
3. Active epilepsy
4. Brain injury or intracranial hypertension
5. Previous AMI, coronary artery bypass graft (CABG)
6. Cardiac arrest
7. Cardiogenic shock, significant mitral regurgitation or intraventricular communication at inclusion
8. Mechanical ventilation at inclusion
9. Significant ventricular arrhythmia or atrioventricular block type II or III at inclusion
10. Decompensated chronic obstructive pulmonary disease at inclusion
11. chronic hepatocellular failure
12. MRI contraindications
13. Gadolinium chelates injection contraindications
14. Current treatment with morphine chlorhydrate, buprenorphine, nalbuphine, pentazocine
Effects of S. Boulardii and Amoxicillin/Clavulanate on Gut Microbiota

The purpose of this study is to compare and contrast the effects of the probiotic Saccharomyces boulardii, the antibiotic amoxicillin/clavulanate and the combination on the gut microbiota of healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 to 65 years (male or female)
* Good general health
* Able to comply with study requirements and to provide informed consent
* For women of childbearing potential oA negative urine pregnancy test immediately prior to starting the study treatment oAgreement to comply with approved methods of contraception during the period of active study treatment (not required during follow-up)

Exclusion Criteria:

* History of organ transplantation
* Known chronic or recurrent systemic disorder associated with immunocompromise
* A history of allergy or hypersensitivity to Saccharomyces boulardii, brewer's or baker's yeast, amoxicillin, penicillins, or cephalosporins
* History of severe allergic reaction (requiring hospital admission and/or the administration of parenteral medication or associated with dyspnoea, wheezing, hypotension, loss of consciousness).
* Oral or systemic antibacterial therapy during the 3 months prior to study enrollment
* New prescription medications during the 4 weeks prior to study enrollment
* Prescription, OTC medications or supplements that are known to alter gut function or microflora (i.e. acid antisecretory drugs, probiotics) during the 4 weeks prior to study enrollment
* Active gastrointestinal disease
* Patients with a central venous catheter
* Patients taking antifungals or laxatives within 14 days of enrolment
* Patients enrolled in other clinical trials within the past 60 days
* Prior gastrointestinal surgery (apart from appendectomy or cholecystectomy)
* History of chronic constipation with passage of fewer than 3 bowel movements per week on average
* Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol.
A Multicenter Collaborative Study on the Clinical Features, Expression Profiling, and Quality of Life of Infantile Onset FSHD

This study is an observational study that aims to advance our knowledge on infantile onset FSHD. The study will include 50 participants of all ages who have presented with symptoms of FSHD between birth and 10 years of age. Study participation will involve a single day of assessments at one of the participating CINRG centers (to include physical exam, cognitive testing, eye exam, hearing test, strength testing and speech evaluations). The procedures may be split over additional days for scheduling purposes.


Eligibility Criteria:
Inclusion Criteria:

Affected participants must have a clinical diagnosis of FSHD, including the presence of all of the following features based on review of medical records and/or direct examination:

* Onset of symptoms involving the facial or shoulder girdle muscles
* Autosomal dominant inheritance in familial cases
* Contraction of the D4Z4 repeat array from 1-10 (10 - 38 kb) copies in the 4q35 subtelomeric region, based on established molecular genetic techniques

Exclusion Criteria:

* Symptomatic cardiomyopathy or severe cardiac arrhythmia which may limit the ability to complete the study protocol
* Maternal/mitochondrial mode of inheritance
* Evidence of an alternative diagnosis based on muscle biopsy or other available investigations
Post ICU Follow up: A Questionnaire Survey of Aftercare in Denmark

This study aims to investigate current aftercare activities in Denmark after intensive care unit (ICU) treatment. The hypothesis is that a large number of hospitals offer aftercare, and these interventions are heterogenic and differ between hospitals and regions.

This study is an electronic questionnaire survey that aim to describe and map Danish aftercare activities, and future development plans in this field.

Annually, more than 30,000 patients are admitted for treatment at Danish intensive care units (ICUs). These critically ill patients are some of the most vulnerable in the health care system.

For years, focus has primarily been on treatment and survival of this patient group. As treatment effectiveness has gradually increased, the overall survival rate is now above 80%. Consequently, the period following ICU discharge has gained increasing focus and follow up interventions in the period after ICU treatment have become more common. These different follow up interventions has given name to the concept of 'aftercare'. Aftercare activities includes both early rehabilitation initiated during the continued hospital admission and also the following rehabilitation after hospital discharge.

Complications after intensive care treatment are numerous, including both physical, cognitive and psychological impairments, e.g. depression, muscle weakness, anxiety and social isolation. Together these symptoms are defined as post intensive care syndrome (PICS).

While it is clear that a need for aftercare exists, the optimal evidence based activities remains to be determined. The current follow-up activities are established as local initiatives and the methods vary greatly. Examples of present aftercare interventions include use of diaries, follow-up consultations, revisiting the ICU and assessment of quality of life.

A recent systematic review examined these different rehabilitation efforts, without finding significant effects of the present interventions, although usage of ICU-diaries had a minor preventive effect on post-traumatic stress syndrome (PTSD). A Danish meta-analysis from 2015 on follow-up consultations showed similar results.

Aftercare is a rapidly developing area and it is necessary to further investigate this important topic. Therefore, the investigators want to describe the current level of aftercare with a new mapping of activities in all Danish ICUs. Hereby, the investigators hope to create a better and up-to-date foundation for further development within Danish aftercare. Furthermore, the investigators wish to research on the clinician-experienced (the participants) attitude towards and limitations for aftercare activities, in order to discuss directions for future development.

Eligibility Criteria:
Inclusion Criteria:

* All Intensive Care Units in Denmark treating adult patients.

Exclusion Criteria:

Intensive care units with a specialty field within these four groups:

* Neurology and neurosurgery
* Cardiothoracic surgery
* Pediatrics or neonatology (PICU/NICU)
* Postoperative care units
Evaluation of Smell and Taste in Fibromyalgia

Patients diagnosed with fibromyalgia syndrome according to 2016 ACR criteria and 18-70 years old healthy subjects will be included in the study. Their smell and taste will be assessed with sniffin sticks and taste strips. Besides they will be evaluated for quality of life, anxiety, depression, and alexithymia.


Eligibility Criteria:
Inclusion Criteria:

* 18-70 years of fibromyalgia patients
* Giving informed consent
* Knowing how to write and read in Turkish

Exclusion Criteria:

* Mentally retarded patients
* Psychiatric disorders (bipolar disorder, schizophrenia etc.)
* Severe organ failure (kidney, liver, heart failure)
* History of head trauma
* Any disorder associated with smell and taste functions
All-ceramic Crowns in Patients With Sleep Bruxism

The aim of the study is to evaluate the complication rate of 2 types of all-ceramic crowns in patients with or without bruxism.


Eligibility Criteria:
Inclusion Criteria:

* need a molar crown
* tooth antagonist (no implant)

Exclusion Criteria:

* no Antagonist pregnancy, bleeding, periodontal diseases
A Study to Evaluate the Effect of Povorcitinib on the QT/QTc Interval in Healthy Participants

The purpose of this study is to evaluate the effect of povorcitinib on the QT/QTc Interval in healthy participants.


Eligibility Criteria:
Inclusion Criteria:

* Ability to comprehend and willingness to sign a written ICF for the study.
* Age 18 to 55 years inclusive at the time of signing the ICF.
* Body mass index between 18.0 and 30.5 kg/m2, inclusive.
* No clinically significant findings on screening evaluations as determined by the investigator (clinical, laboratory, and ECG).
* Ability to swallow and retain oral medication.

Exclusion Criteria:

* History of uncontrolled or unstable cardiovascular, respiratory, renal, gastrointestinal, endocrine, hematopoietic, psychiatric, and/or neurological disease within 6 months of screening. Participants with any history of myasthenia gravis will be excluded.
* Presence or history of a malabsorption syndrome possibly affecting drug absorption (eg, Crohn disease or chronic pancreatitis).
* Current or recent (within 3 months of screening) clinically significant gastrointestinal disease or surgery (including cholecystectomy and excluding appendectomy and hernia repair) that could affect the absorption of study drug or moxifloxacin.
* History of cardiovascular, cerebrovascular, peripheral vascular, or thrombotic disease or uncontrolled hypertension (systolic blood pressure \> 140 mm Hg or diastolic blood pressure \> 90 mm Hg at screening, confirmed by repeat testing).
* Positive test for HBV, HCV, or HIV. Participants whose results are compatible with prior immunization for or immunity due to infection with HBV may be included at the discretion of the investigator.
* History of tobacco- or nicotine-containing product-use within 1 month before screening.
* Pregnant or breastfeeding.

Other protocol-defined Inclusion/Exclusion Criteria may apply.
Prospective Study of Motion Preservation Evaluation Below Fusions of the Spine in Adolescent Idiopathic Scoliosis

The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis.

The motion behavior in the unfused segments of the spine following instrumentation is poorly understood and the implications of hyper or hypo-mobility have not been clearly defined. The purpose of this study is to evaluate the relationship of A) The distal fusion level B) The total length of fusion and the post-operative range of motion in the unfused vertebral segments below the fusion in patients with Adolescent Idiopathic Scoliosis to answer the following specific clinical questions:

1. Further elucidate the motion behavior of the distal unfused spinal segments, specifically:

   1. Does motion differ at various post-operative time points (2 year post-op patients versus 5 or 10 year post-op patients)?
   2. Can predictive factors be identified with post-operative altered motion?
2. Further elucidate the relationship of the motion in the unfused spinal segments to the lowest instrumented vertebrae.
3. Determine the relationship of the total length of fusion to the motion in the unfused spinal segments (i.e. compare unfused motion in the distal unfused segments in Lenke 5/6 patients fused selectively (ThL/L only) versus nonselectively (TH and ThL/L)).
4. Determine the relationship between clinical examinations (i.e. reports of pain or functional limitations) and patient reported outcomes (Health Related Quality of Life Outcome Tools) to motion in the distal unfused segments.

Eligibility Criteria:
Inclusion Criteria:

* Patients presenting to the primary and co-investigator's facilities will be offered inclusion into the study if they meet the following inclusion criteria:

  * Patient age \< 21 years
  * Male or female
  * Diagnosis of Adolescent Idiopathic Scoliosis
  * Any Lenke Classification type
  * Underwent surgical correction of the spinal deformity with a fusion
  * Are due for their 10 year post-operative visit

Exclusion Criteria:

* Patients will be excluded from study inclusion if they meet the following exclusion criteria:

  * Neuromuscular co-morbidity
Improving Pediatric Safety and Quality With Health Care Information Technology

This study includes four projects aimed to improve the quality and safety of pediatric care through the implementation of four clinical decision support services in the electronic health record (EHR). The four projects will measure the effect of each clinical decision support feature including: weight-based dosing; smart forms for chronic conditions; guideline reminders; and a results manager to track abnormal lab result follow-up.

Hypothesis: Implementation of the clinical decision support features will decrease medication errors and adverse drug events, assist physicians in adhering to clinical practice guidelines and protocols for certain chronic illnesses, improve physician follow-up for abnormal lab results, and overall improve the safety and quality of pediatric clinical practice.

please see description above

Eligibility Criteria:
Inclusion Criteria:

* Partners-affiliated pediatric practice providers utilizing Longitudinal Medical Record (LMR), which is an electronic health record system. Also the parents of the patients of the above noted pediatric providers.

Exclusion Criteria:

* Non-Partners providers, or Partners providers who do not use LMR. Parents of patients not seen by Partners-affiliated pediatric providers who use LMR.
PRONTO: Obstetric and Neonatal Emergency Training Program: A Cluster-Randomized Trial to Measure Impact

Rates and causes of maternal mortality in Mexico have dropped only slightly; thus, reaching the internationally established Millennium Development Milestones (MDM) is still a distant goal. A fundamental part of reducing maternal and infant mortality is ensuring an adequate and timely response to obstetric emergencies. PRONTO2: Obstetric and Neonatal Emergency Training Program is an innovative training strategy based on simulations designed to train hospital personnel to respond to obstetric emergencies. The objective of this study is to implement PRONTO2 in selected hospitals to measure the effectiveness of the intervention in influencing key behaviors in hospital practices, as well as measuring maternal and neonatal outcomes in intervention versus control hospitals.


Eligibility Criteria:
Inclusion Criteria:

* Hospitals must be located in Guerrero, Chiapas, or Mexico states
* Number of deliveries and cesareans was between 500 and 3000 in 2009

Exclusion Criteria:

* Inaccessible by car
Regional Blood Flow During Peripheral Heating

Blood flow through the popliteal, brachial, and carotid arteries during peripheral heating of the feet


Eligibility Criteria:
Inclusion Criteria:

* between 18 and 65 years

Exclusion Criteria:

* open wounds on feet or legs
Carotid Artery Stenting With Protection Registry

The purpose of this study is to evaluate ischemic events and neuropsychological changes after carotid artery angioplasty and stenting with a neuroprotection device.

Stroke is the third most common cause of death in North America with approximately 750,000 new strokes reported annually, of which 150,000 are fatal. Approximately 75% of strokes occur in the distribution of the carotid arteries. Among those, a thrombotic etiology (carotid occlusive disease) is one of the most common causes. Recently published studies have shown that patients who underwent carotid stenting in combination with a cerebral protection device had better overall outcomes as related to stroke, death and MI as opposed to carotid endarterectomy. What is not known is whether protection devices which allow some particles (100 micron particle size or less) to pass through the filter or particles that embolize during placement or removal of the protection device, will have any delayed abnormal outcomes as determined by neuropsychological testing.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than 18 and less than 90
* Symptomatic as evidenced by transient ischemic attack or non-disabling stroke in the hemisphere supplied by the target vessel within 180 days of procedure. Must have anatomic stenosis greater than 70% by ultrasound or angiography performed in previous 30 days
* Asymptomatic patients with a stenosis greater than 80% by ultrasound or angiography performed in previous 30 days
* Patient has no childbearing potential or has negative pregnancy tests within one week prior to procedure.
* Patient and patient's physician agree to have the patient return for all the required clinical contacts following study enrollment
* Patient signs informed consent
* Patient has been excluded from other multi-institutional trials

Exclusion Criteria:

* Patient has evolving stroke or intracranial hemorrhage
* Allergy to trial required medications
* Active bleeding diathesis or coagulopathy, or will refuse blood transfusions
* History of major ipsilateral stroke with sufficient atrophy to increase risk of procedure associated bleed
* Severe dementia
* Previous intracranial hemorrhage or brain surgery within the past twelve months
* Patient has any condition that precludes angiography or would make a percutaneous procedure unsafe
* Patient or family inability to understand or cooperate with study procedures
* Recent GI or remote bleed that would interfere with anti-plate therapy
* Severe vessel tortuosity or calcification that would preclude introduction of guiding catheter, guiding sheath, or stent placement
* Extensive diffuse atherosclerotic disease involving the arch or common carotid that would preclude safe introduction of catheters and sheaths for endovascular therapy
* Intraluminal filling defect
* Intracranial aneurysm greater than 6 mm, AVM, or other intracranial vascular abnormality that would preclude safe intravascular intervention
Diabetes Reversal and the Subgingival Microbiota

This study seeks to examine the impact of bariatric surgery on oral bacteria in diabetic compared to non-diabetic patients. The purpose of this research study is to examine how diabetes changes the bacteria in the mouth. This is an important question since bacterial changes may impact oral health. Participants will attend a screening and baseline visit prior to bariatric surgery and three post bariatric surgery appointments (3 weeks post, 6 months post and 1 year to 18 months post). Samples collected at each study visit include blood, plaque, and other oral samples. At the last study visit there is an optional dental cleaning.


Eligibility Criteria:
Inclusion Criteria:

* Men and women undergoing bariatric surgery who are 25-65 years old.
* BMI \> 35 kg/m2.
* Diabetic subjects: HbA1c\> 6.0% or fasting plasma glucose \>126 mg/dl).
* Normoglycemic subjects: HbA1c\<5.75% or fasting plasma glucose \<100 mg/dl).
* Dental criteria: Minimum of 4 posterior teeth.
* Signed and dated informed consent form.
* Willing to comply with all study procedures and be available for the duration of the study.

Exclusion Criteria:

* Subjects diagnosed with type 1 diabetes, maturity onset diabetes of the young (MODY), or latent autoimmune diabetes in adults (LADA).
* Women who are considering pregnancy or are currently breastfeeding.
* Individuals with a history of chronic inflammatory or autoimmune diseases or taking medications that affect immune function or affect body weight such as chronic systemic steroids.
* Currently smoke more than 10 cigarettes per day.
* Periodontal treatment within 3 months of bacterial sampling.
* Acute periodontal infection (abscess) within 1 month of bacterial sampling or abscess in teeth or adjacent teeth within 1 month of sampling.
* Treatment with antibiotics within one month of sample collection (except as part of the surgical regimen of prophylactic antibiotic immediately prior to surgery).
* A treatment regimen of steroids within 1 month of sample collection.
Prospective Epidemiological Study of Upper Limb Venous Thrombosis

Venous thrombosis of the upper limb is one of the manifestations of venous thromboembolic disease.

The epidemiology and management of upper limb venous thrombosis is much less well documented than that of lower limb venous thrombosis.

The investigators wished to provide epidemiological data concerning upper limb venous thrombosis in the hospital setting.

The researchers would like to know the prevalence of this pathology among patients hospitalized in a university hospital center. In order to obtain this prevalence, the investigators wish to carry out a monocentric cross-sectional descriptive study.

Venous thrombosis of the upper limb is one of the manifestations of venous thromboembolic disease.

The epidemiology and management of upper limb venous thrombosis is much less well documented than that of lower limb venous thrombosis.

The investigators wished to provide epidemiological data concerning upper limb venous thrombosis in the hospital setting.

The researchers would like to know the prevalence of this pathology among patients hospitalized in a university hospital center. In order to obtain this prevalence, the investigators wish to carry out a monocentric cross-sectional descriptive study.

The main objective of the study is to define the prevalence of upper limb venous thrombosis in patients hospitalized at Nantes University Hospital.

The secondary objectives are to describe the epidemiology according to the patient's hospitalization sector or the endovenous medical devices used. Another secondary objective is to describe the clinical signs associated with thromboses and their characteristics.

The investigators wish to include major patients hospitalized at the Nantes University Hospital in different sectors (medical, surgical, intensive care units). After collecting the patient's non-opposition, reseachers will carry out a venous duplex ultrasonography of the upper limbs.

Data concerning the hospitalization unit, the patient's comorbidities, the presence of venous tracts or other endo-venous devices, clinical signs and duplex ultrasonography data will be collected using a standardized collection grid.

Eligibility Criteria:
Inclusion Criteria :

* Patient (major, pregnant woman) hospitalized in a department of the Nantes University Hospital and accepting participation in this research

Exclusion Criteria :

* Opposition to the completion of the review, minors, adults under guardianship.