cyrilzakka/clinical-trials huggingface dataset:
A Comparison of p53-induced Genes Activation in Patients With and Without Acute Myocardial Infarction

The purpose of this study is to compare p53-induced genes activation as possible markers differentiating between patients presenting with acute myocardial infarction and controls.

The diagnosis of acute myocardial infarction is based on the rise of bio-markers for cardiac necrosis such as troponin. While troponin measurement is highly sensitive for myocardial necrosis it has several limitations that influence its clinical use. First, since the troponin test is reliable only after 4-6 hours from symptoms onset, it has only limited value in the assessment of patients presenting earlier. Second, several clinical situations, most commonly renal dysfunction, are associated with increased troponin level and therefore may decrease the specificity of the test. Third, since troponin rise indicates myocardial infarction it is not useful in the common situations where there is myocardial ischemia without necrosis.

The P53 is a tumor suppressing gene activated in different stressful situations including hypoxia. This activation is associated with accelerated transcription (up to 30-50 folds from baseline) of different genes that are involved in apoptosis, DNA repair and in stopping the cell cycle. A study on pregnant women demonstrated high levels of fetal mRNA of these genes in maternal circulation. This gene expression correlated with other signs of fetal stress associated with hypoxia. Myocardial ischemia is another stressful event associated with tissue hypoxia. Nevertheless, the association of this gene expression with myocardial ischemia has not been investigated yet.

Eligibility Criteria:
Inclusion Criteria:

Acute MI group:

Patient presenting with chest pain lasting for at leasY 1 hour and no more than 6 hours accompanied by 1 of the following ECG criteria:

* ST segment elevation of anterior or inferior wall (at least 2 consecutive leads)
* New LBBB

Controls:

* Patients undergoing non-invasive evaluation of possible myocardial ischemia

Exclusion Criteria:

* Chronic lung disease requiring chronic treatment
* Any malignancy in the 5 year prior to enrollment
Lost Children Society (LCS), Online Therapeutic Tabletop Role-playing Game for Early-onset Schizophrenia Patients

The Lost Children Society (LCS) is a Therapeutic TableTop Role-Playing Game specifically developed for early-onset schizophrenia patient.

It is performed online via a secure teleconsultation and videoconference platform.

Patients are connected from their home, on their personal computer or tablet, equipped with headsets with microphone.

This study aims to validate the feasibility of this online Therapeutic TableTop Role Playing Game.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of early onset schizophrenia
* Patient who has the capacity to understand the protocol and to perform evaluations
* Written informed consent to participate in the study given by the patient or by the parental authority of the minor patient.
* Patient with social security coverage

Exclusion Criteria:

* Intelligence quotient\<70 on Wechsler Adults Intelligence Scale-IV (for 17+ years) or the Wechsler Intelligence Scale for Children V (for 15-16 years).
* Personal history of head trauma, neurological disorder, genetic disease.
* Co-morbidities: major depressive episode or post-traumatic stress disorder unresolved or resolved within the last 6 months.
* Lack of mastery or access to a computer or personal tablet in autonomy
* Therapeutic history of metacognitive training.
* Patient under guardianship, curators or legal protection
* Patient going through a period of exacerbation of positive or negative psychotic signs likely to lead to a full-time hospitalization in a specialized environment within the next 3 months
Brown Adipose Tissue Activity and Age

In this study the investigators aim to investigate whether the sympathetic stimulation of BAT, as assessed with a 123I-metaiodobenzylguanidine single-photon emission computed tomography computed tomography scan, differs between young and elderly subjects, as an explanation for the diminished metabolic brown adipose tissue activity in the elderly.

The investigators hypothesis is that sympathetic nervous system activity in the elderly is diminished as compared to their younger counterparts as an explanation for the diminished metabolic brown adipose tissue activity in the elderly.

The sympathetic nervous system is the primary activator of Brown Adipose Tissue.

Elderly are known to have less metabolically active brown adipose tissue as compared to their younger counterparts.

The reason for this diminished metabolic brown adipose tissue activity is unknown.

However, a lower sympathetic nervous system activation to brown adipose tissue in the elderly might explain a diminished metabolic brown adipose tissue.

Therefore, in this study, both the sympathetic nervous system activation to brown adipose tissue and the metabolic activity will be measured in young and older subjects.

sympathetic nervous system activity will be measured using 123I-metaiodobenzylguanidine single-photon emission computed tomography computed tomography scans, metabolic activity will be measured using 18F- fluorodeoxyglucose positron emission tomography CT scans.

Eligibility Criteria:
Inclusion Criteria:

* Male
* Caucasian origin
* Subjects should be able and willing to give informed consent
* 18-65 years old
* BMI range of 19-27 kg/m2

Exclusion Criteria:

* Renal failure (creatinine\>135mmol/l)
* Daily use of prescription medication
* Prior participation in a research protocol involving radiation exposure in the last 2 years
Perceived Alcohol Rewards and Risks Study

The identification of mechanisms that underlie how people reduce or eliminate alcohol use is a critical public health issue. Understanding these mechanisms can inform how to effectively intervene with problem drinkers. Thus far it has been a challenge for the alcohol research field to find consistent empirical evidence in support of candidate mechanisms of behavior change. Scientific advancement in this area may be aided by longitudinal transdisciplinary research on the interplay between behavioral intervention, cognition, and brain activity to understand underlying processes of behavior change among heavy drinkers. This study employed a randomized 2-arm repeated measures design with a sample of non-treatment seeking adult heavy drinkers to examine changes in perceived reward value and risks of alcohol use as a mechanism of alcohol behavior change after a brief behavioral intervention. Participants were randomized to either a 1-session behavioral intervention or to an attention-matched control condition and immediately after completed an fMRI scan. The focus of this project is to examine if group differences in perceived alcohol reward value after the intervention mediates an intervention effect on reducing alcohol use in the 1 month following the intervention.


Eligibility Criteria:
Inclusion Criteria:

1. engaged in regular heavy drinking, as indicated by consuming 5 or more drinks per occasion for men or 4 or more drinks per occasion for women at least 4 times in the month prior to enrollment
2. a score of ≥ 8 on the Alcohol Use Disorder Identification Test (AUDIT)

Exclusion Criteria:

1. under the age of 21
2. currently receiving treatment for alcohol problems, history of treatment in the 30 days before enrollment, or currently seeking treatment
3. a positive urine toxicology screen for any drug other than cannabis
4. a lifetime history of schizophrenia, bipolar disorder, or other psychotic disorder
5. serious alcohol withdrawal symptoms
6. history of epilepsy, seizures, or severe head trauma
7. non-removable ferromagnetic objects in body
8. claustrophobia
9. pregnancy
Trial of Surf and Hike Therapy for Major Depressive Disorder

This study uses a randomized controlled trial design to compare the psychological effects of surf therapy to hike therapy in active duty service members who have been diagnosed with major depressive disorder.

This prospective, longitudinal randomized controlled trial will enroll up to 86 active duty service members with major depressive disorder who are seeking surf or hike therapy as part of their standard medical care. Participants will be randomly assigned to receive 6 weeks of either surf or hike therapy. Assessor-administered and self-report measures will be completed at pre- and post-program, as well as three months following program completion. Participants also will complete brief, self-report assessments before and after each program activity session.

Eligibility Criteria:
Inclusion Criteria:

* Be a military service member seeking surf or hike therapy as part of the Wounded, Ill, and Injured Wellness program at Naval Medical Center San Diego;
* Have medical clearance to participate in these programs;
* Have a current diagnosis of Major Depressive Disorder based on DSM-5 criteria.

Exclusion Criteria:

* Service members who are currently receiving surf or hike therapy (i.e., have already started attending program sessions);
* Service members who are currently pregnant
Diagnosis and Treatment of Patients With Cystic Fibrosis

This is an omnibus protocol for studying patients with cystic fibrosis. The main purpose of the study is to obtain samples and data collected during standard clinical care for future research to expand knowledge of the natural history, clinical manifestations (phenotypes) and the genetic variants (genotypes) of cystic fibrosis.

This is an omnibus protocol for studying patients with cystic fibrosis. The main purpose of the study is to obtain samples and data collected during standard clinical care for future research to expand knowledge of the natural history, clinical manifestations (phenotypes) and the genetic variants (genotypes) of cystic fibrosis.

Eligibility Criteria:
* INCLUSION CRITERIA
* Patients with known or suspected CF and family members of patients with CF.
* \>=4 years of age

EXCLUSION CRITERIA

-Concomitant medical, psychiatric or other problems which might complicate interpretation of studies of CF, or for which we are unable to provide adequate care.
Chartis Collateral Ventilation Measurement: Conscious Sedation Versus General Anesthesia

Rationale: The Chartis® ( Pulmonx, CA, USA) measurement system is a tool to assess interlobar collateral ventilation during bronchoscopy. Assessing collateral ventilation is important when you intend to treat a patient with endobronchial valves. Chartis measurement of collateral ventilation can be performed under both conscious sedation as well as general anesthesia. There is no consensus on what is the preferred method of anesthesia for Chartis measurements in the literature.

Objective: In this project we want to investigate whether there is a difference in Chartis measurement outcomes between these two methods of anesthesia: conscious sedation and general anesthesia.

Study design: This study will be a single center observational study

Study population: The study population exists of patients with severe emphysema who undergo collateral ventilation assessment before bronchoscopic lung volume reduction treatment with one-way endobronchial valves.

Intervention: All patients will undergo two subsequent Chartis measurements. The first measurement will be performed with the patient undergoing conscious sedation and the second measurement with the patient under general anesthesia.

Main study parameters/endpoints: Our primary outcome measure is the failure rate of the Chartis collateral ventilation measurement under general anesthesia versus conscious sedation.


Eligibility Criteria:
Inclusion Criteria:

* Patient is scheduled for a bronchoscopic lung volume treatment using one-way valves
* Patient has provided signed informed consent.

Exclusion Criteria:

For safety reasons patients that meet the following criteria will not be included in this study:

1. FEV1 \<20%
2. RV/TLC\>70%
3. pCO2 \>6.5
4. RVSP\>40mmHg
5. 6MWT\<200m
6. Known intolerance to Lidocaine
7. Any other medical reason/condition that warrants a short procedure (physician judgement )
Pilot Study to Investigate the Efficacy of a Toothpaste in Providing Relief From Dentinal Hypersensitivity

A pilot study to determine the ability of a stannous fluoride containing toothpaste to provide immediate and short term relief from dentine Hypersensitivity compared to a control toothpaste.


Eligibility Criteria:
Inclusion:

* Self-reported history of dentinal hypersensitivity lasting more than 6 months and less than 10 years
* Teeth showing signs of facial/cervical gingival recession and/or signs of erosion or abrasion.
* Teeth having a gingival index score of less than or equal to 1
* Teeth with a clinical mobility less than or equal to 1
* sensitive teeth from those meeting the EAR, GI and mobility criteria at screening, with sensitivity as measured by tactile stimulus (Yeaple probe, tactile threshold 10g) and evaporative (air) stimulus (Schiff Sensitivity Score ≥ 2).

Exclusion:

* Presence of chronic debilitating disease which could affect study outcomes.
* Any condition which causes xerostomia.
* Dental prophylaxis within 4 weeks of screening.
* Tongue or lip piercing or presence of dental implants.
* Professional desensitising treatment within 12 weeks of screening.
* Gross periodontal disease, treatment of periodontal disease (including surgery) within 12 months of screening, scaling or root planning within 3 months of screening.
* Teeth bleaching within 12 weeks of screening.
* Tooth with evidence of current or recent caries, or reported treatment of decay in 12 months of screening.
* Tooth with exposed dentine but with deep, defective or facial restorations, teeth used as abutments for fixed or removable partial dentures, teeth with full crowns or veneers, orthodontic bands or cracked enamel. Sensitive teeth with contributing aetiologies other than erosion, abrasion or recession of exposed dentine, or not expected to respond to treatment with an over-the counter dentifrice.
* Daily doses of a medication which could interfere with the perception of pain.
* Currently taking antibiotics or have taken antibiotics within 2 weeks of baseline.
* Individuals who require antibiotic prophylaxis for dental procedures.
Compare the Pharmacokinetics of NVP-1805 and Coadministration of NVP-1805-R1 With NVP-1805-R2

The purpose of this study is to compare the pharmacokinetics of NVP-1805 and coadministration of NVP-1805-R1 with NVP-1805-R2.

pharmacokinetics and safety of NVP-1805 compared to coadministration of NVP-1805-R1 with NVP-1805-R2

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult subjects who signed informed consent
* BMI of \>18.0 kg/㎡ and \<30.0 kg/㎡ subject, weight more than 50kg(45 kg or more for woman)

Exclusion Criteria:

* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
* Inadequate subject for the clinical trial by the investigator's decision
* Subjects participated in another clinical trial within 6 months prior to administration of the study drug
Trial of Pulse Steroid Therapy in Kawasaki Disease--Pediatric Heart Network

The primary endpoint is coronary artery diameter, normalized for body surface area, 5 weeks after randomization. Secondary endpoints include duration of fever, CRP levels, and adverse events.

BACKGROUND:

Kawasaki Disease (KD) is an inflammatory vasculitis of unknown etiology that affects infants and children and can cause coronary artery aneurysms. Standard therapy consists of 2 gm/kg of intravenous immune globulin plus high-dose aspirin in the acute phase, and low-dose aspirin in the convalescent phase. Some children do not respond to this therapy, and some children go on to develop coronary artery aneurysms in spite of aggressive treatment. This led to the design of this randomized controlled trial to compare a single dose of intravenous steroids vs. placebo on the background of standard therapy. Recruitment began in December, 2002 and ended in December, 2004 with nearly 200 patients randomized.

DESIGN NARRATIVE:

This is a randomized controlled trial to compare a single dose of intravenous steroids vs. placebo on the background of standard therapy

Eligibility Criteria:
* Fever persisting at least 4 days and the presence of at least 4 of the following 5 principal features:

  1. Changes in extremities: Acute changes include erythema and edema of hands and feet; Convalescent changes include membranous desquamation of fingertips
  2. Polymorphous exanthema
  3. Bilateral, painless bulbar conjunctival injection without exudates
  4. Changes in lips and oral cavity: Erythema and cracking of lips, strawberry tongue, diffuse injection of oral and pharyngeal mucosae
  5. Cervical lymphadenopathy ( 1.5 cm in diameter), usually unilateral;

OR

* Patients with at least four days of fever and coronary artery disease, defined as either:

  1. Having a z-score in either the proximal right coronary artery or the proximal left anterior descending coronary artery of \> 2.5 detected by 2-dimensional echocardiography, as well as:
* For patients under six months of age, at least two principal criteria
* For patients at least six months of age, at least three principal criteria. 2. Meeting Japanese Ministry of Health criteria for coronary aneurysm defined as an internal lumen diameter of \>3 mm in children less than 5 years of age or \>4 mm in children 5 years of age and older, in either the proximal right coronary artery or the proximal left anterior descending coronary artery and at least one principal criterion.

AND Enrollment within ten days of the onset of illness, with Day 1 defined as the first day of fever AND Informed consent of parents and assent of children who are older than age 7 years and capable of understanding or according to institutional guidelines.
The Effect of Erector Spinae Block on Diaphragma Movement

Laparoscopic cholecystectomy surgeries cause moderate/severe pain and thus can result in shallow breathing, atelectasis and increased opioid consumption in the early postoperative period which in turn cause a longer hospital stay. Erector spinae plane block has been shown to decrease lower thoracic pain after laparoscopic cholecystectomy surgeries. This study aims to investigate the effect of erector spinae plane block on opioid consumption and diaphragma movement after laparoscopic cholecystectomy surgeries.


Eligibility Criteria:
Inclusion Criteria:

* Ages between 18 and 65
* Patients in American Society of Anesthesiologists Classification I or II
* Elective laparoscopic cholecystectomy surgery performed under general anesthesia

Exclusion Criteria:

* Patient refusal
* Patients who can not provide informed consent or with a known psychiatric disease
* Patients with a known allergy to study drugs
* Patients using anticoagulants and corticosteroids
* Patients with diaphragma hernia, chronic obstructive pulmonary disease, lung cancer
* Patients who are not able to use a patient controlled analgesia device
Acupuncture for Sedation in the Intensive Care Unit (ICU)

BACKGROUND Many patients in the trauma intensive care unit (TICU) require mechanical ventilation and sedation or anxiolysis. Mechanical ventilation means that a machine is helping a patient breathe if he can't breathe on his own. Because of the mechanical ventilation, these patients also require some medication to help keep them calm. These are called sedatives or anxiolytics.

The purpose of this study is to see if acupuncture can lower the amount of sedation and anxiolysis needed by a subject during mechanical ventilation in the TICU. Acupuncture is a medical procedure. Hair-thin sterile needles are inserted at specific points on the body.

PROCEDURES Some subjects will get acupuncture and others will get 'fake' acupuncture. By using 'fake' acupuncture, no one other than the acupuncturists will know which group a subject is in. Subjects and the team do not get to pick which subject is in which group. Instead, the groups are picked randomly. Subjects will get real or fake acupuncture twice a day for five days.

Standard of care - Both groups will receive the standard of care while in the study. They will be mechanically ventilated and given sedatives and analgesics based on the TICU protocol.

Real acupuncture group - This group will receive real acupuncture with real needles. These are stainless steel, one time use, needles. This group will also receive "ear tacks" which are like little needles that can stay on the ear for a few days. The ear tacks will be covered with a bandage so no one can tell which group the subject is in.

Sham acupuncture group - This group will receive sham needles. These needles retract into themselves much like a 'magic sword' rather than poking the skin. Subjects in this group will not get ear tacks. In order to hide the group the subject is in, a bandage will be used to cover part of the ear.

HYPOTHESIS Real acupuncture will decrease subject's sedation requirements by 30% when compared to the sham acupuncture group.


Eligibility Criteria:
Inclusion Criteria:

* Trauma patient ≥ 18 years admitted to the Trauma ICU
* Injury Severity Score (ISS) ≥ 4
* Mechanically ventilated \< 24 hours with anticipated need \> 24 hours

Exclusion Criteria:

* Inability to obtain consent from patient or designee
* Receiving immunosuppressive therapy
* Receiving therapeutic anticoagulant therapy
* History of bleeding disorder, INR \> 1.5, PTT \> 65, PLT \< 20K
* Pregnancy
* Three (3) or more inaccessible acupoints
* Head injury with elevated intracranial pressure or requiring operation
* Patients with midline abdominal incision
* Non-english speaking
* Receipt of dexmedetomidine prior to or during study period
Trial Of Azithromycin In Campylobacter Concisus Patients With Diarrhea

A randomized, double-blind, placebo-controlled clinical trial of azithromycin in Campylobacter concisus culture positive patients with diarrhea. The clinical characteristics of emerging Campylobacter concisus in adults is vomiting and persistent diarrhea. Whether patients may benefit from antibiotic treatment is unknown. The purpose of this trial is to investigate whether antibiotic treatment with azithromycin of Campylobacter concisus induced diarrhea can better the symptoms and shorten the duration of illness.


Eligibility Criteria:
Inclusion Criteria:

* Patients with culture-positive stool sample with Campylobacter concisus
* Diarrheic patients ≥ 18 years
* symptoms of diarrhea defined as three or more watery stools per day or
* two watery stools per day + at least one of the following symptoms: abdominal pain, nausea, vomiting or fever.
* Diarrheic symptoms for a minimum of 24 hours before enrollment.
* Diarrheic symptoms for a maximum of 21 days before enrollment.
* Informed oral and signed written consent, with documentation that all relevant information about the study is given to the patient.
* The patient must be willing and able to participate in the trial.

Exclusion Criteria:

* Hypersensitivity to azithromycin, erythromycin, macrolide or other ketolide-antibiotics
* Pregnancy or breastfeeding (if relevant).
* Culture positive stool sample with a Co-pathogen.
* Treatment with other antibiotics (in any stage 21 days before the first stool sample).
* Patients with severe liver disease.
* Patients with severe renal impairment (GFR \<10 ml / min).
* Patients with congenital or documented acquired QT prolongation.
* Patients treated with other active drugs that prolong the QT interval such as: antiarrhythmics of classes IA and III, cisapride and terfenadine.
* Patients with electrolyte disorders, particularly hypokalemia and hypomagnesemia.
* Patients with clinically relevant bradycardia, arrhythmia or severe heart failure.
* Inflammatory bowel diseases
* Chronic diarrhea of known cause.
* Dementia.
* Serious illness less than 21 days from the planned entry into the study.
* Patients treated with medications that have interactions with azithromycin e.g. alkaloids, ciclosporin or amiodarone.
* Patients involved in the planning or execution of the study.