cyrilzakka/clinical-trials huggingface dataset:
SHARE Program: SUSTAIN

The goal of PROJECT SUSTAIN is to optimize Healthy Choices to advance an adaptive and scalable intervention designed to improve self-management of alcohol and HIV in Young People with HIV (YPWH) while understanding the context for state-wide implementation and sustainment in a Hybrid Experimental Design (HED). SUSTAIN utilizes mHealth and telehealth intervention delivery of Healthy Choices (HC), combined with text messaging between sessions, to increase the likelihood of daily medication adherence (primary outcome), and increase the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3 (secondary outcome).

Primary aim: To test whether, on average, delivering (vs. not delivering) a text messaged prompt focused on medication adherence or stress increases the likelihood of medication adherence by the end of the current day.

Secondary aim: To test whether offering (vs. not offering) a Healthy Choices telehealth coaching session at the end of week 2 (day 14) increases the likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3.

Implementation Aim: Assess barriers and facilitators to the implementation and sustainment of intervention sequences for state-wide scale up using mixed methods (EPIS qualitative interviews, youth satisfaction and dose received, fidelity for telehealth, paradata for mHealth, and cost-effectiveness analysis).

Cross-project Moderator Aim: Explore age, biological sex and gender, ethnicity, other substance use, and mental health as moderators of intervention effects.

Primary hypothesis to be tested: Delivering (vs. not delivering) a text messaged prompt will lead to greater likelihood of medication adherence by the end of the current day.

Secondary hypothesis to be tested: Offering a Healthy Choices telehealth coaching at the end of week 2 will lead to greater likelihood of achieving viral suppression and meeting criteria for no risky alcohol use at month 3 (post-intervention) compared to not offering a Healthy Choices telehealth coaching session at the end of week 2.

Eligibility Criteria:
Inclusion Criteria:

* Be 18 years and 0 months to 29 years and 11 months.
* Currently reside in Florida
* History of alcohol use
* Are not pregnant nor trying to conceive within the study's timeline
* Are able to read and understand English
* Have internet access via smartphone, tablet or computer
* Are willing to provide informed consent.

Exclusion Criteria:

* Adults unable to consent
* Prisoners
* Those using long-acting injectables as HIV medication regimen
The Effect of Curcumin for Treatment of Cancer Anorexia-Cachexia Syndrome in Patients With Stage III-IV of Head and Neck Cancer

A study of Curcumin to prevent cancer anorexia and cachexia Syndrom in locally advance and advance stage head and neck cancer (stage III, IV)


Eligibility Criteria:
Inclusion Criteria:

* Head and neck cancer stage III-IV
* Cancer anorexia cachexia syndrome by 2011 Cancer cachexia an International Consensus
* Enteral feeding with Nasogastric Tube or Gastrostomy
* ECOG 0-2
* Normal Bone marrow, kidneys, and liver function
* Normal function of enteral digestion and absorption

Exclusion Criteria:

* Pregnancy
* History of allergy to Curcumin or herbal medicine
* History of Herbal medicine used
* History of Billiary of obstruction
* History of Antiplatelete or anticoagulant.
Resistant Bacteria in Children in France

This study is observational, multicenter and prospective study for surveillance of the use of new antibiotics in pediatrics for treated pediatrics infections due to multi-resistant bacteria

The main of this study is to evaluate the relevance of prescribing "new antibiotics" according to the antibiogram of the isolated bacteria or in the absence of bacteriological documentation

As this is a surveillance study, the clinical and biological characteristics of the children included will be described.

Eligibility Criteria:
Inclusion Criteria:

* Children under 18 years of age
* Hospitalized in France in a hospital center working with the ACTIV/GPIP network
* Treated with one or more of the following antibiotics:

  * Colimycin (Colistimethate sodium)
  * Cefiderocol
  * Aztreonam in combination
  * Ceftolozane-Tazobactam
  * Ceftazidime-avibactam
  * Meropenem/vaborbactam
  * Imipenem/Relebactam
  * Tigecycline
  * Daptomycin
  * Ceftaroline fosamil
  * Tedizolid phosphate
  * Fidaxomicin
  * Ceftobiprole
  * Dalbavancin

In association with a documented infection performed by:

* Blood culture
* Normally sterile site

  * Cerebrospinal fluid
  * Pleural fluid
  * Pleura
  * Peritoneum
  * Joint fluid
  * Other
* Urine sampling if the bacteria was considered responsible for the infection (associated with a leukocyturia ≥10,0000)
* Respiratory specimens if the bacteria was considered responsible for the infection
* Sampling on material such as:Intubation probe, Orthopedic, Urological, Central Nervous System (CNS),....

  * Related to colonization with multidrug-resistant bacteria without documentation.

Exclusion Criteria:

* Refusal of participation by the patient or his/her parent
* Medical history of mucoviscidosis
Randomized Controlled Prospective Multicenter Study Primary Onlay- Mesh After Elective Median Laparotomy in Patients With BMI ≥ 27

Incisional hernia is one ot the most frequently seen long term complications in abdominal surgery. Despite studies on the optimal suturing technique for laparotomies, the risk for incisional hernia after midline incision remains about 5-20 %. One major risk factor for incisional hernia after a median laparotomy is obesity.

The closure technique of midline incisions has remained unchanged since many decades and primarily consists of suturing the linea alba. Interest in prevention of incisional hernias with the aid of synthetic mesh is growing and only one large randomized trial is active recruiting patients in Germany, Netherlands and Belgium (Prima Trial).

Patients with a BMI of more than 27 have a high risk of developing an incisional hernia after midline incision with an incidence of 22% after 12 months. This high risk group of patients may benefit from prevention.

Some small studies have been performed to evaluate the usefulness and safety of primary laparotomy wound closure with the aid of prosthetic mesh. These studies show a very low risk for incisional hernias and a low infection rate, even when used in contaminated wounds such as colostomy surgery.

The goal of this study is to evaluate the effectiveness of incisional hernia prevention after elective median laparotomy in patients with a BMI of more than 27. A randomized controlled trial will be performed comparing the commonly used technique of running suture to close with the aid of a prosthetic onlay mesh. The primary outcome measure will be incisional hernia occurrence. Secondary outcome measures will be complications, surgical site infections, post-operative pain and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Every elective midline laparotomy for patients with a BMI of more than 27. Signed informed consent

Exclusion Criteria:

* Age \< 18 years
* Emergency procedure
* Inclusion in other trials
* Previous midline incision
* Life expectancy less than 24 months
* Pregnant women
* Immune suppression therapy within 2 weeks before surgery
Differential Effect of Four Mindfulness Exercises

Mindfulness can be considered as a family of complex attentional and emotional regulation strategies that promote the cultivation of well-being and emotional balance. The practice of mindfulness produces the development of a consciousness that unfolds moment to moment, open and unprejudiced in the present moment, here and now. Despite its extensive benefits, the practice of mindfulness requires a significant commitment in time and effort, which limits the potential for its dissemination. The studies to narrow the differential effects of the various exercises based on mindfulness, will further enhance their effectiveness and they can guide the practice sequence according to user needs. In this paper we will research mindfulness electroencephalographic correlates of as four different exercise programs included in mindfulness-based cognitive therapy (MBCT) and stress reduction program based on mindfulness (MBSR) as well as its effect on several psychological variables.

Mindfulness is a way of using attention intentionally, repeatedly reactivating the attentional focus, so that it enhances the ability of sustained attention. It involves a complex process of self-regulation and inhibition of internal and external stimuli interferences.

Although the overall effects of meditation on brain bioelectrical signals are still being characterized, there is some consensus on the fact that meditation helps alter brain activity in both state and trait.

The specific aim of this study is to assess the differential effect of four different practices of mindfulness in psychological well-being and their corresponding neurophysiological correlates.

The hypothesis is that different exercises within the range of mindfulness practices exert different effects in terms of electroencephalographic activity, expecting different band increases in alpha (activity 7-to 2 Hz), beta (activity more than 13 Hz), theta (activity 4-6 Hz) and delta (activity less than 3 Hz) respectively, as well as changes in the lateralization of the activity (left or right hemisphere). We also expect an improvement in the variables such as mindfulness, self-compassion, positive affect, anxiety, depression and sleep quality.

Eligibility Criteria:
Inclusion Criteria:

* sign of informed consent
* no previous meditation training experience

Exclusion Criteria:

* mental or neurologic disorder
* respiratory disease
* previous brain damage history
* medication intake that could interfere in the electroencephalographic results
A Clinical Trial of the Optimal Treatment Period and Long-term Efficacy of Functional Electrical Stimulation (FES) on Sleep Bruxism

To investigate the effect of the treatment with Grindcare® on the parafunction of the muscles- and jaw activity (Bruxism) during sleep.


Eligibility Criteria:
Inclusion Criteria:

* RDC-TMD diagnosis
* Verified sleep bruxism
* More than 18 Years
* Signed ICF

Exclusion Criteria:

* Contraindication of concomitant medication and diseases judged by investigator
* Pacemaker
Nasogastric Tube in Premature Babies - Pain and Treatment

Does sucrose or pacifier influence pain in premature babies when a nasogastric tube is inserted?

A total of 24 premature babies are randomised to receive either placebo (sterile water), 30 % sucrose, or pacifier in a complete factorial, cross-over design. Pain is rated on the PIPP scale by observers blinded to the procedure other than use of pacifier.

Eligibility Criteria:
Inclusion Criteria:

* 28 - 32 weeks gestational weeks
* not on mechanical ventilation

Exclusion Criteria:

* high risk group regarding cerebral prognosis
Cough Determinants in Mechanically Ventilated Patients

In our knowledge there is only few data about the cough determinants in mechanically ventilated patients. However some failure of extubation is due to inefficiency cough. In order to determine some determinants of cough, the investigators propose to evaluate systematically different physiological parameters before and after extubation.

In order to evaluate, and identify the cough determinants, the investigators propose a physiological evaluation for each patients who were intubated and mechanically ventilated during at least 72 hours. Indeed inefficacy of cough after extubation is one of the main reason of extubation failure. However there is no any mean to evaluate it simply now.

Eligibility Criteria:
Inclusion Criteria:

* Patients mechanically ventilated since 72h
* Age \> 18 years
* Hospitalized in Intensive care Unit
* In weaning phase - with the classically criteria to be extubated
* Patients who passed the weaning test (T tube test or other)

Exclusion Criteria:

* Hemodynamic instability
* Absence of consent
* No cooperation of the patient
* Hemodynamic instability
* pH \< 7,30
* Severe hypoxemia
Adaptation and Pilot Testing of a Behavioral Parent Training Program for Parents of Deaf and Hard of Hearing Children

Despite being more likely than typical hearing children to experience disruptive behavior problems, children who are deaf and hard of hearing (DHH) rarely receive behavioral interventions to prevent the long-term costly outcomes of behavior problems. This pilot project will systematically adapt an evidence-based behavioral parent training (BPT) intervention to increase its acceptability and relevance for parents of young DHH children. Two parents of DHH children will be trained in the adapted BPT for DHH children. They will each deliver the intervention to five families with DHH preschool-aged children.


Eligibility Criteria:
Parent/Caregivers and Children:

Inclusion Criteria:

* Parent/caregiver is age 18 years or older
* Parent/caregiver is the custodial guardian of a deaf or hard of hearing (DHH) child
* DHH child is 2-5 years old
* DHH child has used hearing aid(s) and/or cochlear implant(s) for \> 6 months
* Parent/caregiver is able to read English and either speak/understand English or use American Sign Language

Exclusion Criteria:

* Active child protective services case
* DHH child of interest has been diagnosed with a severe developmental delay, severe autism, debilitating neurological condition, etc.
* Parent/caregiver has already accessed behavioral health services for the DHH child

Parent Coaches/Interventionists:

Inclusion Criteria:

* Age 18 years or older
* Parent of a DHH child
* Able to speak, understand, and read English

Exclusion Criteria:

- None
Study of Body Composition Methodology in Young Children (InfantPod)

The InfantPod study is a cross-sectional study designed to determine how practical and precise a body composition method is for measuring body fat and lean tissue in infants and children ages 5 months to 3 years.


Eligibility Criteria:
Inclusion Criteria:

* Healthy children between ages of 5 months and 3 years

Exclusion Criteria:

* Child that has any condition that may affect growth
* Child that has any chronic disease
* Child that has any carbohydrate metabolism disorder
* Child that takes any medications that may interfere with study parameters as determined by the investigator
Transcranial Direct Current Stimulation (tDCS) for Treatment-Resistant Obsessive-Compulsive Disorder (FRONT)

Neuromodulation techniques for the treatment of Obsessive-Compulsive Disorder (OCD) have expanded with the greater understanding of the brain circuits involved in this disorder. Transcranial direct current stimulation (tDCS) is a non-invasive neuromodulation technique that has been studied as an alternative for strategy for treatment-resistant OCD. The main study is a randomized, sham-controlled, double-blinded trial tDCS for OCD patients unresponsive to cognitive-behavioral therapy and/or selective serotonin reuptake inhibitors. Forty-four patients will be randomized to two groups: active or simulated intervention. The intervention consisted of delivering an electric current of 2mA to the cathode, positioned bilaterally in the cranial region corresponding to the supplementary motor cortex, and the anode positioned in the deltoid (neutral region), during 30-minutes, for four consecutive weeks. The primary outcome was the reduction in baseline YBOCS scores before and after of tDCS treatment. Secondary outcomes include measures of depressive and anxiety symptoms, genetic markers, motor cortical excitability and performance in neurocognitive tests.


Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with OCD according to DSM IV criteria
* YBOCS score of 16 and above or ≥10 (for the presence of only compulsions or only obsessions)
* Patients with other psychiatric comorbidities are not excluded, however, OCD should be the most important disease .
* Age between 18 and 65
* Patients who failed one or more treatments
* Patients with no previous treatment for OCD will be treated with one first line treatment before being considered to participate in the tDCS trial.
* Voluntary and competent to consent

Exclusion Criteria:

* Other diagnostic axis I whose treatment take precedence over the treatment of OCD (bipolar affective disorder; dependence alcohol; schizophrenia or psychotic disorders; dementia)
* Presence of other neurological diseases or severe clinical as neurodegenerative diseases, severe aphasia, malignancies activity, epilepsy, previous head injury, congestive heart failure or chronic obstructive pulmonary disease stage III or IV;
* Presence of severe suicidal ideation (Structured planning suicide or attempted suicide in the past 4 weeks);
* Pregnancy;
* Inability to provide informed consent;
* Specific contraindication to tDCS: ( metal plates on the head, anatomic changes.);
* In relation to the current use of psychotropic drugs will be permitted, provided they are in doses stable for at least 6 weeks.
Dexmedetomidine PKPD Modeling and the Influence of Auditory Stimulation on Dexmedetomidine Effect

Dexmedetomidine is an α2-adrenoceptor agonist that has only recently been registered for human use in Europe. It has sedative, analgesic and anxiolytic properties, but patients remain arousable. This makes it an ideal drug for procedures which require the patient to perform tasks, or for light sedation during procedures or in the Intensive Care Unit. Pharmacokinetic models of (anaesthetic) drugs can be used in target controlled infusions (TCI), to deliver stable plasma concentrations of drug during anaesthesia or sedation. There are several models available for dexmedetomidine at this time, but the most often used models (Dyck and Talke) underpredict the plasma concentration at higher concentrations. Also, plasma concentrations aren't what the clinician is interested in, but in the effect. Therefore, pharmacokinetic/pharmacodynamic (PKPD) models can be developed to titrate the drug to effect instead of plasma concentration, using TCI. This has been done for many anaesthetic drugs, but not for dexmedetomidine. Additionally, we want to investigate the effect of stimulation on the pharmacodynamic effect of dexmedetomidine. The reason for this is that patients under dexmedetomidine sedation are arousable by noises or touch. An operating room or ICU is never quiet, and there are always sounds of monitors, alarms, and talking between team members or activity around another patient in the same room, therefore the stimulation of the patient in such an environment may have a profound effect on the sedative effect of dexmedetomidine.


Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists (ASA) Physical Status 1
* No medical history of significance
* No chronic use of medication, alcohol, drugs or tobacco (oral contraceptives excluded)

Exclusion Criteria:

* Contraindications for use of dexmedetomidine
* Known intolerance to dexmedetomidine
* Body mass index (BMI) \<18 or \>30 kg/m2
* Volunteer refusal
* Pregnancy, or currently nursing
* Bilateral non-patent ulnar artery
To Assess the Efficacy and Safety of SCD-044 in the Treatment of Moderate to Severe Atopic Dermatitis

This is a Phase II, randomized, double-blind, placebo-controlled study in subjects with moderate to severe atopic dermatitis.

This is a Phase II, randomized, double-blind, placebo-controlled study to determine the effect of SCD-044 in subjects with moderate to severe atopic dermatitis.

Eligibility Criteria:
Inclusion Criteria:

1. Aged at least 18 years.
2. Males and non-pregnant non-lactating females, diagnosed with chronic atopic dermatitis for ≥ 1 year at Screening and Baseline based on Eichenfield revised criteria of Hanifin and Rajka.
3. Moderate to severe atopic dermatitis at Screening and Baseline

Exclusion Criteria:

1. Female Subjects who are pregnant, nursing, or planning to become pregnant during study participation or within 6 months of completing the study.
2. Known organ complications of Diabetes mellitus such as reduced renal function, significant retinal pathology or neuropathy.
3. History or presence of uveitis

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Prevalence of Antiphospholipid Antibodies Among Women With Preeclampsia

The purpose of this study is to determine the prevalence of positive antiphospholipid antibodies among women with preeclampsia and to determine the effect of antiphospholipid antibodies on the severity of preeclampsia and the obstetric outcomes

For all women included in the study, blood samples will be tested for anticardiolipin antibodies and lupus anticoagulant. The clinical details of all women will be collected by reviewing their hospital and prenatal records. The following clinical characteristics will be evaluated: maternal age, previous gestations, parity, past or family history of preeclampsia, gestational age at the onset of preeclampsia, gestational age at delivery and birth weight. The following pregnancy and delivery complications will be assessed: placental insufficiency, intrauterine growth restriction, fetal loss (stillbirth) and early neonatal death.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women with preeclampsia.

Exclusion Criteria:

* Women with systemic autoimmune disease.
* Women with active thromboembolic disorders.
* Women with history of previous thromboembolic disorders.
Bowel Prep Acceptance in Clinical Practice

Bowel preparation for colonoscopy is crucial, since the diagnostic accuracy of the procedure depends on an adequate visualization of the mucosa of the colon.There is strong evidence that the quality of bowel preparation is inversely correlated with the interval between the end of the assumption of the purgative and the start of colonoscopy (shorter intervals are associated with higher levels of preparation).Recent studies have shown that split dose prep significantly improves the quality of bowel cleansing. In light of these data, both the American College of Gastroenterology (ACG) and the European Society of Gastrointestinal Endoscopy (ESGE) recommend now split dose prep in order to improve the quality of bowel cleansing. Despite these recommendations, the uptake of schemes in divided doses appears clearly underused in actual clinical practice. In particular, in Italy only a few centers routinely adopt the regime split as their first choice for the preparation for colonoscopy.The reasons why the "split dose" is under-utilized in clinical practice are not entirely clear, but probably in part reflecting gastroenterologists' concerns about potential elements that theoretically could make it less acceptable to the patient (get up early in the morning, potential problems during the journey from home to the hospital) The hypothesis of the study is that many patients would still be willing to accept these potential drawbacks if they were adequately informed about the positive impact of the scheme in divided doses on the effectiveness of bowel preparation, which results in higher reliability of the examination, shorter duration of the procedure, and less risk of rescheduling the exam in the near future


Eligibility Criteria:
Inclusion Criteria:

* adult patientes undergoing colonscopy

Exclusion Criteria:

* afternoon colonoscopy
* partial colonoscopy
* ASA III-IV
* pregnancy
* incapacity to give informed consent