cyrilzakka/clinical-trials huggingface dataset:
Web-based vs In-person Personalized Feedback Intervention for Comorbid Substance Use and Disordered Gambling

Rates of gambling and substance use behaviors are elevated among emerging adults (ages 18-24), and these behaviors are individually and jointly associated with a host of negative consequences. Evidence suggests there is significant overlap between these behaviors as well as comorbidity of associated mental disorders (i.e., pathological gambling and substance abuse/dependence). Prior research suggests that a brief in-person delivered personalized feedback intervention (PFI) may be an effective method of reducing these behaviors and their associated consequences among emerging adults. Thus, the purpose of this study is to determine the relative efficacy of an in-person delivered PFI versus a Web-based PFI in reducing gambling, alcohol and marijuana use behaviors and related-consequences in a sample of emerging adults, as well as explore potential moderators and mediators of intervention efficacy and the longevity of intervention effects (over a period of 18-months).


Eligibility Criteria:
Inclusion Criteria:

* Endorse disordered gambling behavior (including 1 or more consequence)
* Meet diagnostic criteria for one or more substance use disorder

Exclusion Criteria:

* Not meeting inclusion criteria
Dyphenhidramine Effect on Prevention of Sevoflurane Induced Post Anesthesia Agitation in Pediatric

The purpose of this study is to investigate the effect of diphenhydramine on the prevention of sevoflurane induced emergence delirium/ agitation in pediatrics. The Investigators hypothesis is that it reduce the incidence of sevoflurane induced emergence delirium/ agitation.

This is an experimental clinical trial in double-blinded randomized controlled design on 50 children aged 10 months to 21 months who underwent general anesthesia with sevoflurane for labioplasty surgery. Fifteen minutes before inhalation anesthetics were discontinued, the subjects were randomly given a placebo or a single dose of diphenhydramine 0, 5 mg / kg intravenously. Subjects were extubated and observed in the recovered space conscious for any agitation or emergence delirium and feasability to return to the ward. Agitation or emergence delirium was assessed by the Pediatric Emergence Agitation and Delirium Score (PAEDS) whereas feasability to return to the ward scored with the Steward score. When PAEDS\> 10 patients were assessed to be agitated or having emergence delirium and administeres rescue tranquilizer ketamine 0.1 mg / kg. Total rescue tranquilizers and clinically significant adverse effects of drugs also recorded.

Eligibility Criteria:
Inclusion Criteria:

ASA I or 2

* no cardiovascular, respiratory or neurologic congenital anomalies
* no allergic reactions, or any contraindication to drugs used in this trial ever documented

Exclusion Criteria:

* congenital anomalies recognized/diagnosed during trial procedures
* hemmorhage \> 15% EBV
* shock or other major anesthesia or surgical complications during trial procedures (hipoxia, atelectasis, unintended disconection of ETT or IV line)
Neurophysiological Characteristics of Subthalamic Deep-brain Stimulation (STN-DBS)

The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated.

The intraoperative neuroelectrophysiological signals were collected from patients undergoing STN-DBS under general anesthesia in the Neurosurgery Department of Wuhan union Hospital, and their preoperative conditions and postoperative efficacy will be evaluated. The intraoperative neuroelectrophysiological signals would be analyzed.

Eligibility Criteria:
Inclusion Criteria:

1. Patients underwentSTN-DBS in neurosurgery department of Wuhan Union Hospital.
2. Patients with Parkinson's disease or dystonia.

Exclusion Criteria:

1.Patients without enough follow-up length.
OMEGA-Study: Effect of Omega 3-Fatty Acids on the Reduction of Sudden Cardiac Death After Myocardial Infarction

Cardiovascular disease (CVD) is the leading cause of death in North America and Europe. The major cause of CVD is atherosclerosis like coronary artery disease (CAD). The results of recent trials hint that the course of CAD may be positively influenced by an increased intake of omega 3-fatty acids. The OMEGA-Trial analyses this effect in subjects who suffered an acute myocardial infarction. They are divided into two groups, both receiving standard post-infarction therapy. The subjects of one group additionally receive 1 gram of omega 3-fatty acids daily for a time-period of 12 months, while the subjects in the second group receive 1 gram olive-oil as placebo. Within the period of 12 months all events are reported and used to analyse the efficacy and safety of the additional therapy with omega 3-fatty acids.


Eligibility Criteria:
Inclusion Criteria:

* Myocardial infarction 3-14 days before randomisation (STEMI and NSTEMI)
* Ability to take Ω-3-FAE or olive oil without risk
* Informed consent

Exclusion Criteria:

* Premenopausal women who are not surgically sterile, who are pregnant or nursing, who are of child-bearing potential and are not practising acceptable means of birth control (pregnancy testing required before randomisation)
* Known hypersensitivity to study medication
* Dislike of fish oil
* Haemorrhagic diathesis
* Unwillingness to discontinue other medications containing fish oil
* Legal incapacity
* History of drug or alcohol abuse within 6 months
* Any investigational therapy within one month of signing informed consent form
Cohort Study of Heart Rate Variability

To examine factors affecting heart rate variability (HRV) and the role of HRV in heart disease. Specifically, to examine the role of HRV: as a predictor of fatal and nonfatal ischemic heart disease over a six year follow-up of the Atherosclerosis Risk in Communities (ARIC) population based, bi-ethnic cohort; on the six year progression of carotid atherosclerosis measured by B-mode ultrasound; and on the incidence of hypertension. Also, to study the effect of elevated fasting insulin, glucose, diabetes mellitus, and other metabolic abnormalities on changes in HRV over nine years of follow-up.

BACKGROUND:

Heart rate variability analysis has been widely used in clinical research as a noninvasive measurement of autonomic function. It has been found to be associated with post-myocardial infarction mortality, hypertension, sudden cardiac death, atherosclerosis, and diabetes. However, little epidemiologic research on HRV had been reported prior to this study in 1996. Almost no data were available on the population distribution of HRV, its correlates in populations, the factors associated with changes in HRV over time, or on the cardiovascular sequelae of impaired autonomic function assessed by HRV obtained from population-based prospective studies.

DESIGN NARRATIVE:

The study was ancillary to ARIC, a population-based, longitudinal study of cardiovascular and pulmonary diseases. The baseline exam was completed in 1987 to 1988, followed by yearly contacts and re-examinations every three years. The present study built on the data collected by the ARIC investigators by retrieving and processing beat-to-beat heart rate data collected during the baseline exam. Five minutes of beat-to-beat heart rate data were obtained from the ARIC cohort participants during their third follow-up visit (Visit) 4 in 1996 through 1998. Time and frequency domain HRV indices were derived for an assessment of autonomic function. The following HRV indices were computed both for the baseline and the nine-year follow-up exam (1996 through 1998) on the 13,000 members of the ARIC cohort: time domain indices; mean heart rate, minimum and maximum heart rate, standard deviation of all normal R-R intervals, the coefficient of variation of all normal R-R intervals, root mean square of the differences of successive R-R intervals, and the proportion of adjacent R-R intervals. Frequency domain indices were also computed, including high frequency power, low frequency power, and the high/low frequency power ratio.

Eligibility Criteria:
Residents of 4 geographically defined areas
Effects of Modafinil in Methamphetamine Dependence

Methamphetamine dependence is a serious public health problem with no pharmacologic treatments currently available. Relapse rates are high in this population. Exposure to cues previously associated with methamphetamine use may induce profound craving in abstinent individuals. Chronic methamphetamine abuse is associated with selective cognitive deficits that may undermine successful participation in psychosocial treatments. Medications which improve cognitive deficits in methamphetamine-dependent individuals may improve abstinence rates, especially in the critical early period of recovery. Modafinil is an atypical stimulant medication with evidence to support its use in treating cocaine dependence and attention deficit/hyperactivity disorder. The proposed studies are designed to evaluate modafinil as a potential treatment for methamphetamine dependence and its cognitive sequelae.


Eligibility Criteria:
Inclusion Criteria:

1. Subjects must be able to provide informed consent and function at an intellectual level sufficient to allow accurate completion of all assessment instruments.
2. Subjects must meet DSM-IV criteria for methamphetamine dependence within the past six months. Subjects may meet criteria for abuse, but not dependence on any other substance with the exception of nicotine. Because of the high comorbidity of methamphetamine and nicotine dependence, excluding nicotine dependence would seriously compromise the feasibility of recruitment. Nicotine use immediately prior to the cue reactivity testing session will be controlled.
3. Subjects must consent to remain abstinent from all drugs of abuse (except nicotine) for 24 hours prior to the cue reactivity testing sessions.
4. Subjects must consent to random assignment to the modafinil vs. placebo conditions.

Exclusion Criteria:

1. Women who are pregnant, nursing or of childbearing potential and not practicing an effective means of birth control.
2. Subjects with evidence of or a history of significant hematological, endocrine, cardiovascular, pulmonary, renal, gastrointestinal, or neurological disease as these conditions may affect heart rate or skin conductance measurement.
3. Subjects with a history of or current psychotic disorder or bipolar affective disorder as these may impact cue reactivity.
4. Subjects who are unwilling or unable to maintain abstinence from alcohol and other drugs of abuse (except nicotine) for 24 hours prior the cue procedures.
5. Subjects meeting DSM-IV criteria for substance dependence (other than nicotine or methamphetamine as appropriate) within the past 60 days.
6. Subjects currently taking B-blockers, anti-arrhythmic agents, psychostimulants or any other agents known to interfere with heart rate and skin conductance monitoring.
7. Known or suspected hypersensitivity to modafinil.
8. Individuals taking medications that could adversely interact with study medications.
9. Subjects with a history of epilepsy or seizure disorder.
Clinical Validation of Continuous and Non-invasive Monitoring of Effective Pulmonary Volume.

The aim of this study is to evaluate/validate a new non-invasive method to continuously monitor effective lung volume in critically ill patients.

The capnodinamyc method is a new monitoring method that provides continuous (breath by breath) measurements of effective pulmonary blood flow (EPBF) and effective end-expiratory l lung volume (EELVCO2). The former refers to the non-shunted fraction of cardiac output and the latter to the functional end-expiratory lung volume (EELV) that contains CO2.

The capnodynamic method is based on the advanced analysis of CO2 kinetics and the law of Conservation of mass. It states that lungs have to eliminate a similar amounts of CO2 as produced by aerobic metabolism and reaches the lung via pulmonary perfusion. For its calculation, two different measurements are needed:

1. Exhaled CO2 measured by infrared optic sensor technology placed in a mainstream configuration between the endotracheal tube and the "Y" piece of the ventilator respiratory circuit.
2. Flow, airway pressure and ventilatory volumes measured by the mechanical ventilator spirometer.

The method requires the generation of cyclic small changes in the alveolar concentration of CO2 which is achieved by introducing a slightly modified breathing pattern. It consists of adding a short expiratory hold in each 3 out of 9 consecutive breaths and requires the patient to be in passive breathing conditions under mechanical ventilation.

EPBF and EELVCO2 have been validated in experimental conditions and the first validations in patients in the setting of general anesthesia are under way.

Methods:

This study on EELVCO2 in critically ill patients involves 2 types of evaluations:

The validation of absolute values of EELV by comparing it with CTsan. The trending ability of EELVCO2 in critically ill patients by comparing it with EIT.

A calculated sample size of 30 patients is required for each objective.

Eligibility Criteria:
Inclusion Criteria:

* All patients on mechanical ventilation in passive breathing conditions in which a thoracic CTscan has been indicated for medical reasons and those with an EIT and a continuous cardiac monitoring
* Informed consent

Exclusion Criteria:

* Hemodynamic instability
* Presence of barotrauma/ pneumothorax
* Presence of bronchopleural fistulas
* Thorax alterations that preclude the positioning of the EIT electrode belt (usually at the IV intercostal space).
Lower Urinary Tract Symptoms in Systemic Sclerosis

Urinary symptoms must be frequent in Scleroderma. In one hand, mobility limitation by joint stiffness and skin sclerosis, forced diuresis due to heart involvement (cardiomyopathy or pulmonary hypertension), diuretics use and corticoid-induced hyperglycaemia, as well as narcotic medication use, puts patients at higher risk of secondary bladder filling and voiding dysfunction. In another hand, few case report and small sample observational studies have identified a specific sclerosis of the urinary tract. Those two mechanisms must be more frequent in the diffuse cutaneous form of scleroderma (dcSSc) compare to the limited one (lcSSc). But prevalence or incidence is unknown.

Urinary symptoms are seldom reported by those suffering from them and are rarely part of a systemic evaluation. In a threatening disease, urinary symptoms assessment might seem to be of no priority. But LUTS have a real impact on many aspect of everyday living. Furthermore urinary tract involvement might predispose to urinary tract infection due to flow limitation and stagnation. Since it is an inner fibrosis it might be associated with a more aggressive form of disease conferring a greater loss of physical function, higher risk for hospital admission and death.

Thus, identifying urinary symptoms would permit to address specific rehabilitation or medication therapy, in order to minimize the consequences of the bothersome symptoms and identify those subjects at higher risk of urinary infection, aggressive disease/loss of function or death.

This study will also give basement to build an interventional study directed toward LUTS treatment in this population.

In this prospective cohort we would like to:

* Compare the prevalence of lower urinary tract symptoms (LUTS) in diffuse and limited forms of systemic sclerosis.
* Determine the prevalence (at inclusion) and incidence (in a two years period) of LUTS among patients suffering from systemic sclerosis.
* Evaluate the impact of LUTS symptoms on Quality of life.
* Compare the discrimination ability of Cochin-hand score and HAQ score to predict incontinence in this population.
* Evaluate the association between LUTS symptoms, hospital admission rate, urinary tract infection, mortality and loss of autonomy.


Eligibility Criteria:
Inclusion Criteria:

Adult suffering from systemic sclerosis included in network of Brescia (I), Geneva (CH), Padova (I) and Paris (F).

Exclusion Criteria:

Those unable to understand the rules and implications of the study, end of life patients, the pregnant women and anuric patients
A Study In Patients With Irritable Bowel Syndrome To Measure Hormone Response After Dosing With GW876008 And Gsk561679

To better understand the way that GW876008 and GSK561679 work on hormone responses in patients with Irritable Bowel Syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Has IBS as defined by the Rome II criteria.
* Clinical laboratory tests at screening showing no clinically significant abnormalities in the opinion of the Principal Investigator.
* Non-tobacco user (abstinence from tobacco use for at least 1 month before the start of the study).

Exclusion Criteria:

* As a result of any of the medical interview, physical examination, evaluation of mental state and psychiatric history or screening investigations the physician responsible considers the subject unfit for the study.
* Subject has any of the following exclusionary psychiatric conditions (Note: current diagnoses are to be based on the M.I.N.I administered at screening).
* 1. A current DSM-IV Axis I disorder such as Dysthymia, Phobia, Major Depression, Obsessive Compulsive Disorder, Body Dysmorphic disorder, or Panic Disorder as a primary diagnosis currently or within 6 months prior to the screening visit.
* 2. A current DSM-IV-TR diagnosis of Antisocial or Borderline Personality Disorder, Dementia, or another current DSM-IV-TR Axis II diagnosis that would suggest non-responsiveness to pharmacotherapy or non-compliance with the protocol; or
* 3. A current (within six months prior to Screening Visit) diagnosis of anorexia nervosa or bulimia; or
* 4. A history of Schizophrenia, Schizoaffective Disorder, or a Bipolar Disorder; or
* 5. Is currently being treated by medication for any of the above psychiatric disorders. Psychiatric medications would include, but not limited to, antidepressants (e.g. SSRIs, SNRIs, TCAs) anxiolytics, antipsychotics
* Subjects who, in the investigator's judgement, pose a current, serious or suicidal or homicidal risk or have made a suicide attempt within the past 6 months or have ever been homicidal.
* subjects who have taken any medication for the treatment of IBS within 1 month prior to screening except for anti-diarrhoeal medications or laxatives for control of bowel habit which is allowed if at a stable dose for 2 weeks prior to randomisation.
* Subjects who are taking NSAIDs including aspirin on a regular basis or within 48 hours of a study day.
* Subjects with a history of PUD \<10 years ago.
* The subject has a history of, or active eating disorder.
A Study to Evaluate the Safety and Efficacy of MEDI8897 for the Prevention of Medically Attended RSV LRTI in Healthy Preterm Infants.

The purpose of this study is to evaluate the efficacy, safety, pharmacokinetics (PK), and antidrug antibody (ADA) response for MEDI8897 in healthy preterm infants who are between 29 and 35 weeks gestational age (GA) and entering their first Respiratory Syncytial Virus (RSV) season.

This pivotal Phase 2b study will determine if MEDI8897 will be efficacious in reducing medically attended RSV-confirmed lower respiratory tract infections (LRTI) in healthy preterm infants entering their first RSV season. The population to be enrolled is healthy preterm infants born between 29 weeks 0 days and 34 weeks 6 days GA who would not receive RSV prophylaxis. A total of 1500 infants will be randomized 2:1 to receive either MEDI8897 or placebo. Participants will be followed for 360 days after dosing. Enrollment is planned at approximately 197 sites across the USA, Canada, Europe, and the Southern Hemisphere.

Eligibility Criteria:
Key Inclusion Criteria:

1. Healthy infants born between 29 weeks 0 days and 34 weeks 6 days GA.
2. Infants who are entering their first full RSV season at the time of screening.

Key Exclusion Criteria:

1. Meets American Academy of Pediatrics (AAP) or other local criteria to receive commercial palivizumab.
2. Any fever (\>= 100.4°F \[\>= 38.0°C\], regardless of route) or lower respiratory illness within 7 days prior to randomization.
3. Acute illness (defined as the presence of moderate or severe signs and symptoms) at the time of randomization.
4. Active RSV infection (a child with signs/symptoms of respiratory infection must have negative RSV testing) or known prior history of RSV infection.
5. Receipt of palivizumab or other RSV monoclonal antibody or any RSV vaccine, including maternal RSV vaccination.
Prevena Incision Management

The question this research project wants to explore is whether using the Prevena Incision Management System (Prevena) will improve sternal wound edge oxygenation in patients undergoing Coronary Artery bypass surgery with Bilateral Internal Mammary Artery grafts.

Coronary artery bypass is the gold standard surgical treatment of patients with complex coronary disease. It is a common operation and more than 16000 procedures per year are carried out in the UK. Recent publications suggest that during the bypass procedure both left and right internal mammary arteries should be used to bypass coronary stenoses. It was noted that using both internal mammary arteries will result in even better long term survival with improved freedom from cardiac events such as myocardial infarction or further coronary intervention than using. The major drawback of using both internal mammary arteries is the increased risk of sternal wound infection and breakdown. The investigators will use Near Infra-Red Spectroscopy (NIRS) to assess the wound edge oxygenation delivery. The NIRS INVOS system the investigators use within Sheffield Teaching Hospitals can measure oxygenation of soft tissue to a certain depth making it suitable for the assessment of wound edge oxygen delivery. Prevena is commercially available and has a CE mark.

The Prevena wound management system differs from conventional wound dressings, it applies negative pressure to the closed wound for 7 days. Wound complications/infections are decreased when this type of wound management system is used. Studies suggest that Prevena achieves these outcomes because of an increase of perfusion in the wound edges and keeping the wound dry. Patients will be randomised to either the Prevena wound management or their standard of care NHS wound management for their procedure. The oxygenation and outcomes of the wounds will be compared through data collection and the patients followed up during their routine inpatient care and 6 week outpatient appointment.

Eligibility Criteria:
Inclusion Criteria:

* Eligible patients are those who require isolated coronary artery bypass surgery, who need at least 2 bypass grafts, and who are deemed suitable by the operating surgeon to have both right and left internal mammary arteries harvested as conduits

Exclusion Criteria:

* Require additional procedures in addition to the coronary bypass or need for internal mammary artery harvest for feasibility study
* Who are deemed by the operating surgeon as unsuitable for bilateral internal mammary artery harvest because of
* Age (75 or older where prognostic benefit of using both internal mammary arteries has been questioned),
* Obesity with a BMI which is higher than 35 (increased risks of wound infection)
* Diabetes (of any type) (increased risks of infection.)