cyrilzakka/clinical-trials huggingface dataset:
PET-CT in Diagnosis of Pancreatic Cystic Neoplasms

Preoperative diagnosis of pancreatic cystic lesions remains a difficult problem in clinical practice. At present, the treatment planning in pancreatic cystic neoplasms is significantly restricted by the limited preoperative diagnosis. Ultrasonography (US), multidetector computed tomography (MDCT) and magnetic resonance imaging (MRI) are the conventional modalities in imaging of pancreatic cystic neoplasms, but by these methods the diagnostic accuracy still remains compromised. Furthermore, recently encouraging results have been obtained in pancreatic cystic neoplasms using 18F-fluoro-2-deoxyglucose positron emission tomography (18F-FDG-PET) The aim of the current project is to evaluate the possibility to enhance the diagnostic accuracy by using the combined 18F-FDG-PET-CT imaging in patients with pancreatic cystic neoplasms by combining PET-CT with MRI and MDCT.

Today, in clinical practice the diagnosis pancreatic cystic neoplasms are based on MDCT, MRI and ERCP followed by surgical exploration. The information gained by conventional imaging modalities is restricted to the morphological details, which usually is insufficient for the definitive staging of the pancreatic cystic neoplasms. Based on these previous studies, it seems that PET especially combined with CT modality could improve the diagnostic accuracy of the pancreatic cystic lesions.

So far, there are only few cases published concerning the role of 18F-FDG-PET-CT in the differential diagnosis of cystic pancreatic lesions. Therefore, more studies are needed to determine the role of combined 18F-FDG-PET-CT in the diagnosis of pancreatic cystic lesions.

The aim of the current project is to evaluate the possibility to enhance the diagnostic accuracy by using the combined 18F-FDG-PET-CT imaging in patients with pancreatic cystic neoplasms by combining PET-CT with MRI and MDCT.

The study consists of 20-30 patients with pancreatic cystic neoplasms. The patients enrolled in the study will be imaged by MDCT, MRI combined with magnetic resonance cholangiopancreatography (MRCP), endoscopic retrograde cholangiopancreatography (ERCP) and 18F-FDG-PET-CT followed by surgery or follow-up. The data will be collected between 2011 and 2013.

Eligibility Criteria:
Inclusion Criteria:

* suspicion of pancreatic cystic neoplasm using US, MDCT, MRI and/or ERCP
* laparotomy planned because of the lesion
* signed informed consent

Exclusion Criteria:

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Influence of an Asthma Education Programme on Asthma Control During Pregnancy

Asthma is the most frequent respiratory disease during pregnancy. In a third of cases, the level of asthma control can decrease during the pregnancy, especially between the 29th and the 36th week. The occurrence of such complications are linked with a high asthma severity level just before the conception and an history of respiratory complications in a previous pregnancy. Many reviews and recommendations claim that pregnant women with asthma should be included in an educational progamme. However, this is poorly studied. The purpose of this study is to observe if an educational programme given before the 20th weeks of gestation has an effect on asthma control until the end of gestation.


Eligibility Criteria:
Inclusion Criteria:

* Pregnant woman (less than 20 weeks of gestation at the inclusion time)
* Diagnosis of asthma before the pregnancy (clinical history and specific medications used)
* Agreement to enter into the study

Exclusion Criteria:

* Pregnant woman (more than 20 weeks of gestation at the inclusion time)
* History of major respiratory problems during previous pregnancy(ies)
* Refusal to enter into the study
Effectiveness of Influenza Vaccination Among General Practitioners

Besides the personal protection, influenza vaccination especially needs to prevent transmission of influenza between GPs and their patients. The question remains if the vaccine is adding substantial benefit to the natural acquired immunity of GPs. Doubts are raised if an inactivated vaccine, which elicit especially humoral immune response, can give enough protection against virus replication and subclinical influenza infections. Until now no effectiveness studies of influenza vaccination were performed among GPs. This study will assess the effectiveness of an inactivated influenza vaccine in GPs against clinical respiratory tract infections and more particular against influenza cases with influenza positive nose and throat swabs (diagnosed by RT-PCR).

Two important aspects emerge when considering influenza vaccination of general practitioners as advocated by many guidelines. Besides the personal protection the vaccine especially needs to prevent transmission of influenza between GPs and their patients. In long-term elderly hospitals a possible benefit of influenza vaccination of the healthcare workers was noticed in reducing mortality among the elderly. But this specific situation is not fully transmissible to the general practice.

GPs, having yearly close contact with several influenza cases, built up a high basic immunity and probably only suffer from minor symptoms. The question remains if the vaccine is adding substantial benefit to this natural acquired immunity. In addition doubts are raised in the literature if an inactivated vaccine, which elicit especially humoral immune response, can give enough protection against virus replication and subclinical influenza infections. Until now no effectiveness studies of influenza vaccination were performed among GPs. High time to look more closer to these issues.

Comparisons: the effectiveness of an inactivated influenza vaccine compared with no vaccine in GPs against clinical respiratory tract infections and more particular against influenza cases with influenza positive nose and throat swabs (diagnosed by RT-PCR), besides serological defined influenza cases and taking important independent variables into account

Eligibility Criteria:
Inclusion Criteria:general practitioner with an active practice in Flanders, Belgium -

Exclusion Criteria:other specialists in medicine

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Effect on Metabolic Parameters of Abilify in SPR

To measure the long-term changes in weight and plasma lipids after switching antipsychotic treatment to aripiprazole

To measure the long-term changes in weight, plasma lipids and fasting blood glucose after switching antipsychotic treatment to aripiprazole, 1 year, open label studies in out and in-patients with schizophrenia.

The measurement of weight and lipid profile and fasting blood glucose will be measured at baseline and every 3 months for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* DSM-IV diagnosis with schizophrenia
* who signed an informed consent

Exclusion Criteria:

* comorbid with substance abuse or substance dependence
* pregnancy or lactation
AFRI Childhood Obesity Prevention Challenge Area

This study is a hybrid type 2 effectiveness-implementation trial of the Family Check-Up 4 Health (FCU4Health), an adapted version of the Family Check-Up, in pediatric primary care. Patients will be recruited based on their age (2-5 years old) and randomized to receive the intervention, FCU4Health, or services as usual. All families will be assessed annually over three years.

The FCU4Health is an assessment-driven, Motivational Interviewing (MI) based, parent training program. Parents complete a comprehensive assessment, including questionnaire of the family environment, parenting skills, and child adjustment and health behaviors, and additional observation data. The FCU4Health coordinator reviews the assessment results with the parents, using MI strategies to engage families in making change to support child behavioral health, and to create tailored follow-up services which include parent training modules and referrals to additional support services in the community.

Eligibility Criteria:
Inclusion Criteria:

* Participating caregiver who is at least 18 years of age and understands English and/or Spanish well enough to complete study assessment.

Exclusion Criteria:

* Two exceptions: (1) Children with special needs that preclude engagement in a nutrition-based behavioral intervention (e.g., g-tube dependence) and (2) children who are in state custody.
Injection of Corticoids for the Treatment of Acute Sprains of the Proximal Interphalangeal Joints of the Fingers.

There is currently no real consensus on the optimal management of acute sprains of the proximal interphalangeal joint of the long fingers.

The aim of this study is to assess the beneficial effect of an injection of corticosteroids for the treatment of this type of sprain (one single sub-cutaneous injection, in the acute phase). This treatment, if effective, might become the treatment of choice for these types of injuries, instead of a prolonged immobilization or a careful early mobilization.


Eligibility Criteria:
Inclusion Criteria:

* Adults over 18 years old
* Type I and II and III of the Eaton classification (except if fracture/luxation with more than 50% of the articular surface injured)
* Trauma of one articulation only
* Consultation within 2 weeks of trauma

Exclusion Criteria:

* Patients under 18 years old and over 80 years old
* Pregnant/nursing women
* Eaton classification Type II with a fracture affecting more than 50% of the articular surface, or persistant instability after reduction.
* Open wounds, nerve lesion with sensitive issue and any wound needing a surgical intervention
* Underlying pathologies: rhumatological, neurological, congenital (giving hyperextensive articulations as a result)
* Corticoids allergy
* Infection within the treated zone
* Trauma antecedents at the level of the tendons.
Investigating a Probiotic on Mothers' Mood and Stress

This is a randomized, placebo-controlled, double-blind, 3 parallel-arm study in pregnant women aged 21 years old and above. The study aims to assess changes in perinatal mood and stress when administering a probiotic starting from either the 3rd trimester (i.e 28-32 weeks of gestational age) or immediately after birth, until 12 weeks post-partum.

To date, limited evidence is available for nutritional interventions in the role of modulation of perinatal mood and stress, even less so for probiotics. The probiotic strain Bifidobacterium longum (BL) NCC3001 has previously been shown to normalize anxiety-like behavior in preclinical models and to reduce feelings of low mood and emotional reaction to fearful stimulus in human adults with irritable bowel syndrome (IBS). The strain is also considered safe and has previously been administered to pregnant and lactating women as well as infants. Therefore, the study aims to evaluate the effect of probiotic (BL) NCC3001 on mood and stress levels during the perinatal period.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women aged 21 years-old or above at recruitment
* Willing and able to provide written informed consent
* Gestational age of 28-32 weeks at Randomization
* Singleton pregnancy at Recruitment
* Able to respond to questionnaires in English
* Hospital Anxiety and Depressive Scale (HADS) score of ≥ 5 (out of 21) for either subscale to indicate some general feelings of low mood and/or stress at screening
* Intention to breastfeed

Exclusion Criteria:

* Not willing and/or not able to comply with the study procedures and requirements
* Food allergy
* Has taken probiotic supplements in the period of 4 weeks prior to screening
* Has received pharmacological treatment for anxiety and/or depression in the period of 12 weeks prior to recruitment
* Major complications during pregnancy e.g., pre-eclampsia, gestational diabetes requiring insulin intervention, severe intra-uterine growth restriction (IUGR), fetal anomalies that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial
* Pre-existing medical conditions e.g., hypertension, diabetes mellitus, thyroid diseases, autoimmune diseases such as Systemic Lupus Erythematosus, antiphospholipid syndrome and other major chronic illness that in the opinion of the investigator may interfere with the pregnancy and participation in the clinical trial
* Active participation in another clinical trial or on-going observational study
Transferrin Saturation and Asthenia in Hemochromatosis

Observational study.

The linked HFE genetic hemochromatosis (C282Y mutation in the homozygous state) is the most common form of genetic iron overload.

Its treatment is based on bloodletting, and takes place in 2 phases, according to the recommendations of the High Authority of Health (HAS). The first phase, called induction, aims to achieve ferritinemia \<50 by performing weekly bleeds.

The second phase, called maintenance, aims to maintain this ferritinemia \<50 by performing bleeding every 1 to 6 months depending on the case.

The treatment is therefore according to the current recommendations only adapted according to ferritinemia, and not according to the effectiveness on the functional symptoms. However, some patients report persistent asthenia during maintenance treatment, despite ferritin levels \<50. This could reflect an incomplete control of their disease, and leads us to raise two points:

* It is known that in some subjects, the Transferrin Saturation Coefficient remains high, despite ferritinemia \<50; it is also known that this elevation of the Transferrin Saturation Coefficient may be accompanied by a rise in circulating free iron, which is toxic for the organism1.
* The asthenia observed in some patients in the maintenance phase could be linked to a high rate of Transferrin Saturation Coefficient.

Our objective is to evaluate, in patients homozygous C282Y in maintenance phase, the association between quality of life and Transferrin Saturation Coefficient .

Eligibility Criteria:
* Inclusion criteria:

  * homozygous C282Y ;
  * in the maintenance phase for at least 6 months ;
  * follow-up at Rennes University Hospital ;
  * patient who has not expressed his opposition to participate in the study.
* Exclusion criteria:

  * Permanent: any cause of modification of the CST unrelated to hemochromatosis (chronic inflammatory disease, excessive consumption of alcohol ...) ;
  * Temporary: infectious syndrome within 7 days before bleeding.
The Involvement of the Gut Hormone GIP in the Pathophysiology of Post Prandial Hypotension

The present study investigates the involvement of the gut hormone glucose-dependent insulinotropic polypeptide (GIP) in the pathophysiology of postprandial hypotension (PPH)

The study is an exploratory, randomised, placebo-controlled, double-blind crossover study comprising two experimental days with an infusion of the GIP receptor antagonist, GIP(3-30)NH2 (NH2 is the aminogroup), and placebo (saline) during a 180-minute mixed meal test (MMT). Eighteen participants, men and women, with MMT confirmed PPH will be included in the study.

Eligibility Criteria:
Inclusion Criteria:

1. Age 18-85 years
2. History of PPH-related symptoms like dizziness, lightheadedness, palpitations, or fainting after meal ingestion
3. Informed consent

Exclusion Criteria:

1. Not fulfilling the PPH diagnosis during the mixed meal test or during the test meal with increased (+25%) number of calories
2. Treatment with antihypertensives
3. Treatment with SNRI (Serotonin and Noradrenalin Reuptake Inhibitor) or treatment within three months before screening visit
4. Allergy or intolerance to ingredients included in the mixed meal
5. Any ongoing medication that the investigator evaluates would interfere with trial participation
6. Any physical or psychological condition that the investigator evaluates would interfere with trial participation, including any acute or chronic illnesses
7. Anaemia (haemoglobin below normal range \<7.3 mmol/L for women and \<8.3 mmol/L for men)
8. Moderate to severe loss of kidney function (estimated glomerular filtration rate (eGFR) \<45 ml/min/1.73 m2) at screening
9. Known liver disease (except for simple steatosis) and/or elevated plasma alanine aminotransferase (ALT) \> three times the upper limit of normal at screening
10. Any concomitant disease or treatment that, at the discretion of the investigators, might jeopardize the participant's safety during the trial
11. Alcohol/drug abuse as per discretion of the investigators
12. Pregnancy or breastfeeding
13. Participation in any other clinical trial during study period
14. Mental incapacity or language barriers that preclude adequate understanding or cooperation or unwillingness to comply with trial requirements or pr discretion of the investigator
Does Radial Artery Cannulation Affect the Perfusion Index(PI) of the Hand in Liver Transplant Operations?

radial artery cannulation is performed by an experienced person, non-invasive blood pressure measurement will be made at 3 stages of the operation (dissection, anhepatic, neohepatic) and the effects of radial artery cannulation on the perfusion index will be evaluated by recording the correlation between radial artery and invasive measurements and the perfusion indexes of both hands simultaneously with Masimo.

Arterial lines placement is for real-time monitoring of blood pressures and arterial blood sampling in critically ill patients or those undergoing complex procedures and surgeries.

Routine monitoring will be performed after the patients are taken to the operating room. Before bilateral radial artery cannulation, allen test will be performed and entrance perfusion indexes will be checked. After radial artery cannulation is performed by an experienced person, non-invasive blood pressure measurement will be made at 3 stages of the operation (dissection, anhepatic, neohepatic) and the effects of radial artery cannulation on the perfusion index will be evaluated by recording the correlation between radial artery and invasive measurements and the perfusion indexes of both hands simultaneously with Masimo.

Eligibility Criteria:
Inclusion Criteria:

Patients undergoing liver transplantation Patients who will undergo intraarterial cannulation

Exclusion Criteria:

Peripheral vascular diseases Prior upper extremity surgery Radial artery injury
Online Mindfulness-based Program for Parents of Children with Autism

The goal of the project is to investigate the effects of online 8-week MBSR intervention on diverse parents to support their children with ASD. The investigators will conduct a randomized waitlist-controlled trial with a sample size 22 parents. This study utilizes psychological, behavioral and psychophysiological measures with parents of children with ASD ages 6-12. The first aim is to determine if parents of children with autism from diverse populations are willing participate in and complete an online MBSR program and if online delivery is as effective as in-person program. The battery of parental-report psychological assessments to measure resilience, parental sleep and stress as well as children's behaviors will be administered before and after the treatment. The second aim is to investigate the effects of a virtual MBSR intervention on cardiovascular and sympathetic nervous activity measured by continuous EDA and EKG. Participants will participate in a validated laboratory stress protocol consisting of mental arithmetic and speech tasks before and after the MBSR intervention.

After the participants eligibility are confirmed, their signatures will be obtained on the consent form. Three data collection phases are included in this protocol: baseline, post 3 months and post 6 months. All tests are identical in which phase. Each test includes a survey packet and the lab experiment. The surveys packet includes: the Connor-Davidson Resilience Scale, Mindfulness Attention Awareness Scale, Parenting Stress Index - 4th edition Short Form, Pittsburgh Sleep Quality Index, Adult Sensory Processing Scale, Strength and Difficulties Questionnaire, and WHO Quality of Life-BREF. For the lab experiment, EKG and EDA data will be collected through lab protocol, which include a 5-min baseline recording followed by Trier Social Stress Test (speaking, math test) and then another 5-min rest period. After that, a pre-recorded 15-min mindfulness practice will be played for the participants to practice. After completing the baseline test, participants will be randomly grouped into the MBSR group or the waitlist controlled group. The online MBSR program is a 8-week group-based, intervention, which will be delivered by a UMASS trained MBSR instructor.

Eligibility Criteria:
Inclusion Criteria:

* have a child aged 6-12 years old that has been diagnosed by a psychiatrist or a psychologist with autism spectrum disorder
* English speaking
* parents do not receive any form of psychological or behavioral treatment at the time of referral
* parents have never participated in a MBSR workshop prior to the enrollment
* parents do not have previous meditation experience
* parents do not have a severe mental illness (self-assessed),
* parents agree to participate in the 8-week MBSR intervention

Exclusion Criteria:

* parents who currently receive psychotherapy or take medications for health issues
Cognitive Retraining and Brain Stimulation for Alcohol Use

The overarching goal of this study is to determine whether combined cognitive training and Transcranial Direct Current Stimulation (tDCS) reduces drinking in high-risk drinkers. To this end, specific study purposes are: 1) replicate previous findings that cognitive retraining reduces drinking levels, 2) test whether cognitive retraining can be enhanced with tDCS, and 3) investigate the neural changes that result from cognitive retraining and tDCS. We hypothesize that those participants who receive alcohol avoidance cognitive training will have greater reductions in drinking. In turn, those participants who receive a higher level of applied tDCS during alcohol avoidance response training will have better avoidance learning, as well as, a larger reduction in drinking behavior. Finally, those participants receiving a higher level of applied tDCS will have more neuronal response associated with alcohol avoidance during the brain imaging session.


Eligibility Criteria:
Inclusion Criteria:

* Age 21-30 years
* At least five binge drinking episodes (4+ drinks for men; 3+ drinks for women) for the past month
* Alcohol Use Disorder Identification Test (AUDIT) score greater than 8
* Right handed

Exclusion Criteria:

* History of treatment for alcohol dependence (AD) or desire for treatment
* History of alcohol withdrawal
* History of brain injury
* Currently taking psychotropic medications (e.g. antidepressants, antipsychotics)
* Female subjects who are pregnant
* Evidence of recent illicit drug use on a urine screen
* Left handed
* Prior participation in a brain stimulation study
* Implanted brain medical devices
* Electromedical devices
* Latex allergy