cyrilzakka/clinical-trials huggingface dataset:
The Effect of Articulatory Gestures on Early Literacy Skills in 4-year Olds

This study will use an experimental design to explore if articulatory gestures (with letters and phonemic awareness training) enhance early literacy skills more than general mouth awareness training (with letters and phonemic awareness training) or letter/phonemic awareness training alone.

Multisensory reading strategies, which recruit one or more of the five senses, are routinely used in general education classrooms as well as with children who are struggling readers. Despite their wide use in schools, little research exists to substantiate the utilizing these strategies to enhance literacy. One type of multisensory reading strategy, articulatory gestures, is of particular interest to speech-language pathologists (SLPs) as they are uniquely positioned to provide speech sound placement cues. Limitations of the few prior studies that exist have prevented the isolation of the articulatory gestures themselves as the main contributor to the gains seen in literacy. This study aims to control for factors such as motivation, engagement, and time on task to explore the specific contribution of articulation strategies during phonemic awareness training on phoneme segmentation, reading of phonemically spelled words, and nonword reading in typically developing four-year old children. Using an experimental design, participants will be randomly assigned to one of three conditions: 1) phonemic awareness training with articulatory gestures, 2) phonemic awareness training with general mouth pictures, and 3) phonemic awareness training with no mouth/articulation pictures at all. Interventions will focus on phoneme-letter correspondence and phonemic segmentation using strategies specific to each group and differences between groups will be considered for pre and posttest measures.

Eligibility Criteria:
Inclusion Criteria:

* Knows 15 letter names
* Passes hearing screening
* Passes Fluharty-2 Language Screening
* Can segment no more than three consonant-vowel (CV), VC, or CVC words into phonemes
* Not able to read more than one word or nonword used in the posttest.

Exclusion Criteria:

* Does not know 15 letter names
* Fails hearing screening
* Fails Fluharty-2 Language Screening
* Can segment more than three consonant-vowel (CV), VC, or CVC words into phonemes
* Reads more than one word or nonword used in the posttest.
Vitamin D Supplementation During Pregnancy for Prevention of Asthma in Childhood

The aim of this study is to prevent asthma symptoms (recurrent wheeze) in childhood by supplementation with high dose vitamin D to the mother during pregnancy. Participants are mothers and children of the ABC (Asthma Begins in Childhood) cohort. Mothers are recruited during pregnancy and receive daily supplement with 2400 IU of Vitamin D3 or placebo from week 24 og gestation to 1 week after delivery. In addition all mothers are advised to take the recommended dose of 400 IU vitamin D daily. The mothers in ABC also participate in an interventional trial with fish oil supplementation, and the vitamin D randomization is stratified by fish oil treatment group. The child is followed with acute and planned vits at the research unit, and wheeze is diagnosed according to predefined algorithms.


Eligibility Criteria:
Inclusion Criteria:

Mother:

* Pregnant in week 22-26 of gestation
* Participating in the ABC-cohort
* Living in Sealand, Denmark
* Fluent in Danish
* Willing to let the child participate in the study

Exclusion Criteria:

Mother:

* Intake of more than 400 IU of vitamin D during the last 6 months
* Endocrinological disease such as calcium metabolic disorder, parathyroid disorder, thyroid disorder or Diabetes type 1
* Tuberculosis
* Sarcoidosis
* In need of diuretics or heart medication including calcium channel blockers
Detecting Recurrent Prostate Cancer With C-11 Choline Positron Emission Tomography: An Expanded Access Study

The purpose of this study is to provide clinical access to PET/CT and PET/MRI with C-11 choline for evaluation of men with biochemically recurrent prostate cancer while awaiting approval of the Washington University Abbreviated New Drug Application for C-11 choline.


Eligibility Criteria:
Inclusion Criteria:

1. Patient must have biopsy-proven adenocarcinoma of the prostate initially treated with curative intent (surgery and radiation therapy are most common treatments but other treatments are also eligible).
2. Biochemical recurrence defined as any of the following:

   * PSA ≥ 0.2 ng/mL in at least two sequential tests for patients treated with surgery.
   * PSA ≥ 2.0 ng/mL above the post therapy nadir for patients treated with radiation therapy, brachytherapy or cryotherapy.
   * PSA ≥ 2.0 ng/ml above the most recent therapy nadir for patients who have received additional treatment in the recurrent setting.
3. Patient must have undergone standard-of-care restaging that does not clearly identify site(s) of active disease. Standard staging examinations may include one or more of the following: CT or MRI, bone imaging (either Tc-99m bisphosphonate scintigraphy or F-18 sodium fluoride PET), OR In-111 capromab pendetide scintigraphy.
4. Age \> 18 years.
5. Patient must be able to tolerate PET/MRI or PET/CT imaging
6. Patient must be able to understand and willing to sign a written informed consent document.
7. Patient must be able to understand and willing to sign an Advance Beneficiary Notice (ABN) (Medicare patient) or a Notice of Non-coverage (NNC) from (non-Medicare patient) that addresses the potential cost to the patient of C-11 choline PET/CT or PET/MRI.

Exclusion Criteria:

1. For patients planned to have PET/MRI:

   * Patient must not have claustrophobia or any other contraindication to MRI as evaluated by a standardized MRI safety questionnaire.
   * If applicable, patient must not have renal insufficiency (estimated glomerular filtration rate \< 30 mL/min/1.73 m2 based on measurement within the past 60 days) or be undergoing dialysis as these conditions preclude safe administration of MRI contrast agents. NOTE: At the discretion of principal investigator, a subject may be allowed to enroll/continue on study and undergo imaging without the administration of contrast in the event of renal insufficiency.
   * If applicable, patient must not have a known prior reaction to gadolinium based MRI contrast agents.
2. For patients planned to have PET/CT:

   * Patient must not have claustrophobia that would preclude PET/CT imaging or other contraindications to CT imaging.
The Influence of Bisphosphonates in the Oral Cavity in Children

The use of bisphosphonates during childhood to ameliorate the skeletal abnormalities associated with osteogenesis imperfecta, idiopathic juvenile osteoporosis, fibrous dysplasia of bone and cerebral palsy. There is paucity of long-term studies among children regarding the safety and efficacy of bisphosphonates.

Osteomyelitis and necrosis of the jaws has been was discovered and reported as a serious adverse event in bisphosphonate-treated adults patients.

To our knowledge, there is no report in the literature about osteomyelitis in children treated with bisphosphonates and the influence of long term treatment with bisphosphonates on children's jaws, the reaction to extractions and on the oral cavity.

Aim of the study: to examine the influence in the oral cavity of bisphosphonate in children

The use of bisphosphonates during childhood to ameliorate the skeletal abnormalities associated with osteogenesis imperfecta, idiopathic juvenile osteoporosis, fibrous dysplasia of bone and cerebral palsy. There is paucity of long-term studies among children regarding the safety and efficacy of bisphosphonates.

Osteomyelitis and necrosis of the jaws has been was discovered and reported as a serious adverse event in bisphosphonate-treated adults patients.

To our knowledge, there is no report in the literature about osteomyelitis in children treated with bisphosphonates and the influence of long term treatment with bisphosphonates on children's jaws, the reaction to extractions and on the oral cavity Aim of the study: to examine the influence in the oral cavity of bisphosphonate in children Materials and methods Population: 50 children treated with bisphosphonate will be included in the study.

The following data will be recorded:

1. age, gender, initial disease, age at diagnosis, additional diseases
2. duration and dosage of the bisphosphonate medication (kind of bisphosphonate, age at the beginning of the drug treatment, duration of treatment, frequency of intake, additional medications)
3. Clinical dental examination was performed for detection of; caries, gingival inflammation and oral hygiene, sequence of dental eruption, teeth extractions, and presence of exposure bone.
4. Unstimulated whole saliva was collected using the spitting method as previously described. Sialochemistry analysis will be performed.
5. Serum analysis findings including: calcium (Ca), phosphorous (P), alkaline phosphatase (AlP) and parathyroid hormone (PTH),vitamin D cross-linked telopeptides (ctx, ntx), bone density. (these examination are performed routinely, in these patients, as part of medical follow up.

Eligibility Criteria:
Inclusion Criteria:

* children treated with bisphosphonate
Diagnostic Study of Adrenal Cortical Function in Children With Septic Shock

OBJECTIVES:

I. Examine adrenal cortical function and the incidence of adrenal dysfunction in children with septic shock.

II. Examine the mortality, length of stay in the PICU, and incidence of multiorgan failure in children with adrenal dysfunction and septic shock.

PROTOCOL OUTLINE:

Patients undergo a corticotropin stimulation test within 8 hours of admission to the PICU. Blood samples for plasma cortisol and corticotropin levels are drawn at time 0 followed by corticotropin 1-24 IV. Additional cortisol levels are drawn at 30 and 60 minutes. Corticotropin is measured by immunoradiometric assay and cortisol is measured by radioimmunoassay. Mean arterial blood pressure, heart rate, and respiratory rate are recorded at baseline and at 60 minutes.

Patients receive routine management for septic shock and multiple organ system failure.

Eligibility Criteria:
PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

Patients admitted to the PICU with septic shock; Hypotension (systolic blood pressure less than 2 standard deviations below age normal) plus 3 or more of the following: temperature greater than 38 or less than 36 degrees Celsius; heart rate greater than 90th percentile for age; respiratory rate greater than 90th percentile for age; WBC greater than 12,000/mm3 or less than 4,000/mm3 or greater than 10% band forms; perfusion abnormalities including lactic acidosis, oliguria, or an acute alteration in mental status

Arterial or central venous catheter in place

--Prior/Concurrent Therapy--

At least one month since prior corticosteroids

--Patient Characteristics--

Renal: No nephrotic syndrome requiring glucocorticoids

Pulmonary: No asthma requiring glucocorticoids

Other: No condition requiring glucocorticoids (e.g., adrenal insufficiency); No uncontrolled diabetes mellitus; No prior adrenal dysfunction (plasma cortisol concentration less than 19 mcg/dL 30 and 60 minutes post corticotropin stimulation); No hypersensitivity to corticotropin
Interactive Psychopharmacologic Effects of Alcohol and Nicotine in Humans

The purpose of this study is to characterize the interactive effects of acute intravenous (IV) alcohol and nicotine administration in male and female smokers and nonsmokers who use alcohol.


Eligibility Criteria:
Inclusion Criteria:

* Male or Female, 21 to 50 years old.

Exclusion Criteria:

* Alcohol or Nicotine Naive
Comparison of Vibrating Mesh Nebulizer Versus Jet Nebulizer in the Pediatric Asthma Patient

The purpose of this study is to compare clinical outcomes related to the current practice of using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe asthma in Children's Medical Center Dallas Emergency Department (CMCED).

The purpose of this study is to compare clinical outcomes related to the current practice of using a jet nebulizer (JN) with aerosol mask (AM) or mouthpiece (MP) versus a vibrating mesh nebulizer (VMN) with a valved-mask (VM) or MP in the treatment of acute moderate to severe asthma in Children's Medical Center Dallas Emergency Department (CMCED). The investigators hypothesize that using the combination of a VMN and VM or MP will result in fewer hospital admissions and decrease length of stay in CMCED when compared to the current practice of using a JN and AM or MP.

Eligibility Criteria:
Inclusion Criteria:

2 to 18 year old (up to 19th birthday) otherwise healthy children with primary diagnosis of acute moderate to severe exacerbation of asthma presenting to Children's Medical Center Emergency Department, Dallas

-

Exclusion Criteria:

* Children \< 2 years old
* Children with comorbid/complex medical conditions such as: congenital or acquired cardiovascular disease, cystic fibrosis, chronic lung disease (other than asthma), bronchopulmonary dysplasia, airway anomalies (e.g., tracheomalacia) or immunodeficiency syndromes.
* Patients with coexisting medical condition such as pneumonia
* Patients in impending respiratory failure as determined by treating physician
* Patients that have had oral corticosteroids within 24hrs of CMCED admission
* Patients that have had bronchodilator treatment within one hour of CMCED admission
Sublingual Methadone for the Management of Cancer Breakthrough Pain

A dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.

This is a dose titration protocol for sublingual methadone hydrochloride for the management of cancer-related breakthrough pain to find the optimal dose.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Experiences episodes of breakthrough pain which respond to opioid therapy
* Controlled baseline pain
* Cognitive status sufficient for accurate completion of assessment form
* Willing to provide written informed consent
* Ability to hold a volume of 1 cc of water under the tongue for 5 minutes

Exclusion Criteria:

* Currently or has received methadone during the previous week
* Recent history of substance abuse
* Severe respiratory impairment or other contraindications to opioids
* Recently received therapies that had the potential to alter pain intensity or response to analgesics
* Symptomatic anemia
Post Market Clinical Follow-up (PMCF)Study of the Contour Neurovascular SystemTM

Cerus Endovascular is sponsoring a prospective, multi-center PMCF to document the safety and performance of the Contour Neurovascular System™ (hereinafter "Contour") in normal medical use.

The primary objective of this study is to document the safety and performance of the "Contour Neurovascular System™. The data from the study will be reported as a Post Market study to the Notified Body as part of the Post Market Surveillance (PMS) and Post Market Clinical Follow-up (PMCF) plan.

Eligibility Criteria:
Inclusion Criteria:

* 1. Patient indicated for treatment of a single, unruptured aneurysm is according to the national/international guidelines.

  2. Age 18 years or older at screening. 3. Patient suitable for non-emergency endovascular embolization of saccular IAs.

  4. IA located at a bifurcation in the anterior or posterior circulation with dimensions consistent with implant size selection guidelines included in the IFU for Contour.

  5. Patient has the necessary mental capacity to participate and is willing and able to participate in the study for the duration of the study follow-up and is able to comply with study requirements.

  6. Patient is able to give their informed consent. This must be demonstrated by means of a personally signed and dated informed consent document indicating that the subject has been informed of and understood all pertinent aspects of the study.
* Exclusion Criteria

  1. Ruptured aneurysm.
  2. Patient anatomy or physiology considered unsuitable for endovascular treatment.
  3. Contraindication for arterial access.
  4. Largest measured IA equatorial diameter \>8.5 mm or \<2 mm.
  5. Largest measured IA neck diameter \>8 mm or \<2 mm.
  6. Target IA contains other devices/implants that could interfere with proper placement of the Contour device (e.g., coils).
  7. Known allergy to platinum, nickel or titanium.
  8. Known allergy or intolerance to contrast agents.
  9. Contraindication to anticoagulants or platelet inhibitor medication.
  10. In the opinion of the investigator, any other medical issue within the brain that precludes the device implantation such as brain surgery, radiation in the target area of intervention, acute traumatic craniocerebral injury, etc.
  11. Other medical conditions that cause an inability to comply with study requirements and/or that could increase the risk of neurovascular procedures or death within 2 years (e.g., liver failure, cancer, heart failure, chronic obstructive pulmonary disease, immunosuppression, neural disease, substance abuse and hematologic disorders etc.).
  12. Participating in another study with investigational devices or drugs that would confound the effects of the study outcomes.
  13. The presence of a condition that may create unacceptable risk during the aneurysm embolization procedure.
  14. Female patient who is pregnant or breastfeeding.
Atorvastatin After Aneurysmal Subarachnoid Hemorrhage

The 3-hydroxy-3-methylglutaryl coenzyme A (HMG-CoA) reductase inhibitors, known as statins, have recently been demonstrated to improve endothelial function. Additionally, numerous studies have shown statins as having antiinflammatory and cell-signaling effects together with a selective up-regulation of the eNOS activity. These findings are of potential benefit for the prevention of cerebral vasospasm after a aneurysmal subarachnoid hemorrhage. Indeed, one of the possible mechanisms for this vasospasm is the eNOS depletion or even increase of eNOS expression after the hemorrhage. The purpose of this study is to observe the immediate effect of statins after aneurysmal subarachnoid hemorrhage (aSAH) in cerebral vasospasm and outcome at one year.

Up to now, the preventive and curative treatment of vasospasm secondary to subarachnoid aneurismal hemorrhage has been based on three major approaches: increasing arterial pressure and cerebral blood flow with the use of triple H therapy, increasing the ischemic threshold of neurons with nimodipine and reopening proximal arteries with angioplasty and/or intra-arterial administration of nimodipine, verapamil, milrinone or papaverine. Recently, several teams have observed the efficacy of diverse statins in the prevention of vasospasm by improving the imbalance between the nitric oxide and the endothelin pathways, a major actor in the physiopathology of vasospasm. Indeed, this family of molecules improve the bioavailability of endogenous nitric oxide and upregulate the endothelial NO synthase.

In humans, statin administered within the first 72 hours showed to significantly reduce the incidence of vasospasm up to 50% an therefore, induce a lower morbidity and mortality of this severely ill population. The aim of this study is to demonstrate that atorvastatin reduces the incidence of cerebral vasospasm-related morbidity and mortality within 1 year post aneurysmal subarachnoid hemorrhage (aSAH) treated by either clipping or endovascular coiling.

Eligibility Criteria:
Inclusion Criteria:

* SAH patient \> 16 years-old admitted to the Pitie- Salpetriere Teaching Hospital
* Securing procedure within 96 hours of bleeding

Exclusion Criteria:

* Securing procedure \> 96 hours of bleeding
* Rebleeding of original aneurysm
The Effects of Psilocybin on Shared Experience in Film Processing

The goal of this clinical trial is to learn whether certain methods of detecting awareness in vegetative or minimally conscious patients (using neuroimaging) are sensitive to the effects of psilocybin (a psychedelic drug). One of these methods includes scanning peoples\&#39; brains while they watch a film. When different individuals watch a film, their brains become synchronized with each other as they watch the plot unfold. Most importantly, if a seemingly unconscious patient also shows the same brain-synchronization, it means they might actually be conscious and aware.

To approach this goal, the investigators will be carrying out this trial in healthy volunteers. This will help better understand whether psilocybin may be a potential treatment for restoring awareness in these patients. The main questions it aims to answer are:

* Does psilocybin enhance or diminish brain synchrony during a film?
* Do changes in brain synchrony reflect differences in each individual\&#39;s conscious experience?

Participants will be asked to:

* Attend two brain scanning sessions and watch a series of film clips, perform a brief mental imagery task, and listen to music - once under a placebo, and once under psilocybin.
* Play a series of games that assess their cognition (memory, reasoning, planning, etc.).
* Perform a series of visual illusions tasks.


Eligibility Criteria:
Inclusion Criteria:

Participants must:

* Have access to an internet connection
* Be in good general health
* Be 19 years of age, or older
* Be willing to follow the study protocol

Exclusion Criteria:

The following people will be excluded from the study. Those who:

* Are unable to read English
* Have high blood pressure
* Are pregnant (determined by a urine pregnancy test at in-person screening)
* Are not using effective methods of contraception with their partner(s) (e.g. oral contraceptive pill, injection, implant, patch, vaginal ring, intrauterine coil, intrauterine device, tubal ligation, or barrier method)
* Are taking chronic administration of tricyclic antidepressants and/or lithium
* Are taking acute administration of serotonin reuptake inhibitors
* Are currently using the antipsychotic medication haloperidol
* Are currently using monoamine oxidase inhibitors
* Have any current or past history of meeting the Diagnostic and Statistical Manual of Mental Illnesses (DSM-V) criteria for schizophrenia, bipolar I, bipolar II, or psychotic symptoms
* Have any first or second-degree relatives with history of above disorders/symptoms
* Have any other diagnosed and/or extreme psychiatric disorders, such as anxiety, depression, post-traumatic stress disorder (PTSD), addiction, obsessive-compulsive disorder (OCD), etc.
* Have any history of suicidal behaviour or current/recent suicidal ideation (determined by the Columbia-Suicide Severity Rating Scale \[C-SSRS\] at in-person screening)