cyrilzakka/clinical-trials huggingface dataset:
Testing Brief Personalized Feedback Integrating EMA Alcohol Cue Information

This study aims to develop a brief intervention that incorporates ecological momentary assessments (EMAs; i.e., four brief surveys per day for 17 days) to create personalized feedback targeting high-risk alcohol use among young adult drinkers. The intervention mainly focuses on providing feedback on individuals' drinking desire and how it varies as a function of a number of real-world factors. Other psycho-educational alcohol-related content is also provided in the intervention including strategies for decreasing exposure to cues that increase drinking desires and how to cope with increased desire to drink. This brief intervention will be used in a randomized controlled trial (RCT) comparing young adults who receive the intervention with those who only complete identical assessments.

The purpose of this study is to develop and test a brief intervention that provides personalized feedback to young adults using participants' own event-level, real-world experiences. The aim of the intervention is to increase young adults' awareness of their desire to drink as it varies as a function of a number of real-world factors including alcohol cues, social context, physical context, anticipation of later drinking, mood, and time of day. The intervention also aims to equip young adults with strategies for reducing exposure to factors that increase their desire to drink, how to cope with an increased desire to drink, and how to reduce potential harms from drinking.

This brief personalized feedback intervention is used in a randomized controlled trial comparing young adults who receive the intervention with those who complete the EMAs but do not receive any personalized feedback. Assessments include an eligibility survey, baseline assessment, 17 days of EMAs (4x/day), and follow-up assessments occurring 2-weeks and 3-months post-intervention. The 2-week and 3-month follow-ups occurred 2-weeks and 3-months, respectively, from Day 17 of the EMA period, because the intervention was delivered on Day 17. The intervention will be examined for its feasibility, acceptability, and its effects in reducing alcohol-related outcomes at the follow-up assessments.

Eligibility Criteria:
Inclusion Criteria:

* 1) Between ages 18-24, 2) Lives in Washington state, 3) Reports drinking at least two days per week in the last six months, 4) Reports at least one heavy drinking episode (4+/5+ drinks for women/men) in the past month, 5) Open to changing drinking behavior, 6) Schedule allows for participation in study with daily surveys, 7) Able to attend Zoom training session, 8) Must have cellphone for daily surveys.

Exclusion Criteria:

* 1) Actively seeking treatment for alcohol use, 2) Currently participating in another study in our research center regarding young adult drinking behavior.
Sub-Threshold Exercise Treatment for Adolescents With Sports Related Concussion

Adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. Both groups will receive standard medical coverage with regular clinic visits. All participants will record symptoms daily on a dedicated web site. All participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. The primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.

Adolescents with concussion will be randomly assigned to a treatment group where they will receive sub-threshold exercise, or assigned to a placebo group where they will receive structured stretching exercises. Both groups will receive standard medical coverage with regular clinic visits. All participants will record symptoms daily on a dedicated web site. All participants will be evaluated at time 1 with (1) structured physical exam, and (2) structured exercise stress test which is terminated when there is symptom exacerbation. The primary outcome measure is time to recovery where recovery is defined as (1) asymptomatic for two consecutive days, and (2) ability to exercise to exhaustion without exacerbation of symptoms, and (3) confirmed by a physician based on a structured physical exam.

Eligibility Criteria:
Inclusion Criteria:

* Adolescent with concussion injury from sports within first 10 days

Exclusion Criteria:

* Evidence of focal neurologic deficit; ADHD; history of moderate or severe TBI; greater than 3 prior concussions (or having history of long recovery from concussion, \>3 mths); inability to understand English
Dairy Intake and Brain Health in Aging

The purpose of this study is to learn if dairy food consumption may help brain health in aging by protecting nerve cells from oxidative damage.


Eligibility Criteria:
Inclusion Criteria:

1. Males and females between 60-85 years of age.
2. Good general health with no concomitant diseases, which would be expected to interfere with the study
3. BMI range 20-35 kg/m2

Exclusion Criteria:

1. Presence of any central neurological disease with the potential to impair cognition(e.g., brain tumor, stroke, epilepsy, motor neuron disease, multiple sclerosis, Alzheimer disease, Parkinson's disease) or prior major head trauma with loss of consciousness
2. Presence of an active unstable and life-threatening systemic illness (e.g., cancer)
3. Presence of major psychiatric disorder within the past 3 years including depression, anxiety, and alcohol (over 3 drinks per day or total of 18 per week) or drug abuse (DSM-IV criteria; Geriatric Depression Score\>6)
4. Presence of diabetes mellitus (defined as a clinical diagnosis or use of an anti-diabetic agent) and metabolic syndrome
5. Use of psychoactive and investigational medications
6. Subjects with MRI contraindications such as pacemaker, aneurysm clips, artificial heart valves, metal fragments, foreign objects or claustrophobia. All subjects subjects will receive a structural MRI as part of this study. Individuals with evidence of infection, infarction, neoplasm or other lesions will be excluded. Individuals found to have abnormalities in their structural MRI will be referred to their primary physician for further evaluation and management.
7. Pregnancy
8. Special diet regimens such as lactose free or vegan
Analysis of the Dentoskeletal Effects of the Expander With Differential Opening

This study evaluates the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Half of participants will undergo rapid maxillary expansion (RME) using the expander with differential opening, while the other half will undergo RME using the conventional Hyrax expander.

Recently, a rapid maxillary expander with differential opening was developed aiming to treat maxillary constrictions greater in the anterior region compared to the posterior region of the maxillary dental arch. The aim of this study is to evaluate the dentoskeletal effects of the expander with differential opening in orthodontic patients in the mixed dentition. Material and methods: Fifty patients with maxillary constriction in the mixed dentition will be prospectively and randomly allocated in one of two study groups. The experimental group will comprise 25 patients who will be submitted to rapid maxillary expansion with the expander with differential opening. The control group will be comprised by 25 individuals who will undergo rapid maxillary expander with the Hyrax expander. Digital dental models will be acquired immediately pre-expansion (T1) and six months post-expansion (T2). The Orthoanalyzer™ software will be used to measure maxillary and mandibular widths, arches perimeter, arches lengths, palatal depth, and inclinations of maxillary and mandibular canines and permanent first molars. The intergroup and interphase comparisons will be analyzed using t tests and paired t tests, respectively (p\<0.05).

Eligibility Criteria:
Inclusion Criteria:

* Both sexes;
* Ages ranging from 7 to 11 years old;
* Mixed dentition;
* Maxillary constriction;
* No previous orthodontic treatment.

Exclusion Criteria:

* Cleft lip and palate and associated syndromes;
* Systemic and/or neurological diseases.
Remote Alcohol Monitoring to Facilitate Abstinence From Alcohol: Exp 1

Directly reinforcing abstinence from alcohol with monetary incentives is an effective treatment for alcohol dependence, but barriers in obtaining frequent, verified biochemical measures of abstinence limit the dissemination of this treatment approach. The goal of this study is to use technological advancements to remotely, accurately, and securely monitor alcohol use with a newly developed smartphone app and breathalyzer. This treatment approach has the potential to facilitate the dissemination of an effective, evidence-based treatment for alcohol dependence to a broader population whose treatment needs are not currently being adequately met.


Eligibility Criteria:
Inclusion Criteria:

* Meet Diagnostic and Statistical Manual (DSM)-5 criteria for alcohol use disorder
* Average 3 or more heavy drinking days (≥5 drinks in one occasion for men, ≥4 for women) per week for the past month on the Timeline Follow-back.
* Must endorse alcohol as their primary drug of use.
* Express a desire to abstain from drinking.

Exclusion Criteria:

* Are currently enrolled in an alcohol treatment program (not including attendance at Alcoholics Anonymous or similar community support meetings).
* Score 23 or greater on the Alcohol Withdrawal Symptom Checklist, a score indicating that medication would be likely required to manage alcohol detoxification.
* Pregnant women, lactating women, or women who are planning to become pregnant in the next 15 months.
Obstructive Sleep Apnea - Autonomic and Vascular Exploration

The goal of this clinical trial is to assess the effect of CPAP withdrawal on vascular and autonomic function in patients with obstructive sleep apnea. The main question it aims to answer is:

• Is the pulse wave amplitude index able to predict the impact of sleep apnea treatment withdrawal (continuous positive airway pressure, CPAP) on endothelial function and baroreflex sensitivity?

Participants will stop using their CPAP for 2 weeks and the investigators will assess vascular and autonomic function before and after the withdrawal. Researchers will compare endothelial and autonomic function at baseline and after 2 weeks of withdrawal to see if there are differences. Moreover, they will assess the association between pulse wave amplitude drop profile and effect of CPAP withdrawal.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years old
* Diagnosed with OSA (AHI ≥15 events/h), confirmed during screening period
* Adequately treated with CPAP therapy for ≥6 months
* Able to give informed consent as documented by signature

Exclusion Criteria:

* Professional drivers will be excluded from the study because temporary withdrawal of CPAP may induce drowsiness.
* We will also exclude patients with conditions that may affect endothelial and autonomic function:

  * Known Diabetes
  * Known heart failure
  * Known chronic kidney disease
  * Pregnant or lactating women
  * Morbid obesity (≥40 kg/m2)
  * Known Excessive alcohol consumption
  * Known Dementia (especially dementia with Lewy bodies). (61)
  * Patients using alpha and beta blockers
  * Known atrial fibrillation
  * Inability to follow the procedures of the study due to language problems or psychological disorders.
Practice of Treat-to-target on Pediatric Systemic Lupus Erythematosus: a Two-center Retrospective Study

Treat to target (T2T) strategies have proved to be useful in several chronic disorders, including Rheumatoid Arthritis. In systemic lupus erythematosus (SLE), T2T strategy has been proposed in order to control disease activity, improve health-related quality of life, and reduce morbidity and mortality. Remission would be the main target, but a low disease activity state (LDAS) could be an acceptable alternative. However, due to SLE protean manifestations, the operational definitions of both remission and LDAS are still in progress. This clinical trial would like to assess the clinical value of T2T strategy in the treatment of children with SLE, optimize the treatment of children with SLE, andimprove the prognosis.

This two-center study retrospectively analyzed the follow-up data of children with systemic lupus erythematosus (SLE) in our center (the Children's Hospital of Chongqing Medical University) and the Children's Hospital of Nanjing Medical University, grouping the patients into two observation groups-low disease activity status Group (LDAS group) and never reached low disease activity group (Never LDAS group). We would analyze the risk factors of SLE that patients cannot reach LDAS by comparing baseline data and treatment conditions of the two groups. Meanwhile, we would evaluate the SLE clinical indicators, SLE disease activity, organ damage, and disease remission state at the end of the follow-up of the LDAS group, in order to assess the clinical value of T2T strategy in the treatment of children with SLE, optimize the treatment of children with SLE, andimprove the prognosis.

Eligibility Criteria:
Inclusion Criteria:

(1）Children with SLE diagnosed by the SLICC classification criteria for systemic lupus erythematosus (2012); (2) Since diagnosed of SLE to follow-up termination, inpatient and/or outpatient follow-up at the research centers shall be carried out at least twice a year, the interval of follow-up is ≤3-6 months, and the total follow-up time is ≥1 year; (3) All children or guardians signed an informed consent file before inclusion.

Exclusion Criteria:

1. the treatment plan is unknown;
2. Excluding deaths caused by other diseases
3. follow-up was interrupted;
4. Follow-up time is less than 1 year, or interval is more than 6 months.
Oxytocin MEG Study

The specific aim of this proposal is to investigate the neurophysiological mechanisms of oxytocin's (OT) prosocial effects in patients with schizophrenia and healthy subjects using magnetoencephalography.

Hypothesis A: When OT is administered to patients with schizophrenia, fear-related amygdala hyperreactivity and fusiform gyrus (FG) and anterior cingulate cortex (ACC) hypoactivity will be normalized.

Hypothesis B: When OT is administered to patients with schizophrenia, the decreased functional connectivity (FC) between the amygdala, FG, and ACC will be normalized.

By elucidating the neurophysiological mechanisms of OT administration on emotional face processing, investigators will bee able to:

1. understand the pathophysiology of the functionally debilitating social cognitive deficits of schizophrenia,
2. test the efficacy of OT in normalizing the neural abnormalities underlying these social deficits, and
3. develop and optimize novel treatments for these currently untreatable deficits.


Eligibility Criteria:
Inclusion Criteria for Patients:

* 18-40 years of age
* Male
* Must comprehend English
* Meet DSM-IV criteria for schizophrenia, schizophreniform or schizoaffective disorder
* None or only minor changes to medications in the past week
* Able to use nasal spray
* Must be capable of providing informed consent
* Clinically stable

Inclusion Criteria for Healthy Controls:

* 18-40 years of age
* Male
* Must comprehend English
* No diagnosis of mental disorder according to DSM-IV TR
* Able to use nasal spray
* Must be capable of providing informed consent
* Clinically stable

Exclusion Criteria:

* Female
* Active substance abuse or dependence as determined by a Urine Toxicology Drug Screening
* DSM-IV diagnosis of any disorder other than schizophrenia
* Medical conditions (atrophic rhinitis, recurrent nose bleeds and cranial surgical procedures (hypophysectomy), congestion or sinus problems that could interfere with the study as per the opinion of the investigator
* Hearing deficits
* A pacemaker, extensive dental work, or any magnetic metal implants
* Any history of severe brain trauma
Teen Adherence in KidnEy Transplant, Improving Tracking To Optimize Outcomes (Stage 1)

The overall goal of the Teen Adherence in KidnEy transplant Improving Tracking TO Optimize Outcomes (TAKE-IT TOO) study is to adapt the successful TAKE-IT intervention, aimed at improving medication adherence in adolescent kidney transplant, for use in 'real world' clinical care. The specific aims of Stage 1 of this study are: (1) To understand the needs and preferences of stakeholders (kidney transplant recipients, parents, and healthcare professionals (HCP)) in order to optimize the TAKE-IT intervention for 'real world' use.

TAKE-IT TOO is a prospective, 3-stage, sequential study using user-centered design techniques throughout. This entry describes Stage 1of TAKE-IT TOO. In Stage 1 we will conduct focus groups (FG) to gather data about the needs and preferences of stakeholders to inform adaptation of the Teen Adherence in Kidney transplant Effectiveness of Intervention Trial (TAKE-IT) intervention and features of a novel e-pillbox and adherence-tracking website. The protocols for Stages 2 and 3 will be submitted separately.

Eligibility Criteria:
Inclusion Criteria:

* Patients: Prevalent kidney-only transplant recipients 12-24 y, ≥3 months post-transplant.
* Parents: Parents of prevalent kidney-only transplant recipients 12-17 y (followed in a participating transplant center). Parents will be eligible to participate even if their child does not participate.
* HCP: transplant healthcare professionals (including representatives from variety of disciplines typically involved in promoting medication adherence)

Exclusion Criteria:

* Patients: Individuals with significant neurocognitive disabilities limiting their ability to understand and participate in their own care. Multiorgan transplant recipients. Patient or parent unable to communicate in English or French (Montreal only)
* Parents: Parents of patients 18-24 years old will be excluded
MANAGE-VT Registry - MANAGEment of Ventricular Tachycardia Outcomes Registry

Data collection registry for patients with ventricular tachycardia to help physicians give better care for patients clinically and procedurally.

After consent from a patient the research team will input patients data from many different categories. There is a link to the PDF for the consent form, a patients anticoagulant medications will be assessed, their ventricular tachycardia (VT) history will be inputted, and their date of birth and zip code will inputted. The research team will then input any EKG's, echocardiograms, VT ablations, ICD's, S-ICD's, lab results, and comorbidities.

Eligibility Criteria:
Inclusion Criteria:

* Must be at least 18 years old
* Must not be

Exclusion Criteria:

-
Selective PDE9 Inhibition With IMR-687 in Adults With Heart Failure With Preserved Ejection Fraction

This study is to evaluate whether 16 weeks of treatment with IMR-687 is a safe and effective treatment for patients with Heart Failure with Preserved Ejection Fraction (HFpEF). The primary objective is to evaluate whether IMR-687 reduces NT-proBNP compared to placebo in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥45 years
* Weight 60 to 160 kg, inclusive
* LVEF ≥45% by echo within 6 months prior to Screening Visit
* Symptoms of HFpEF requiring treatment with a diuretic(s) for at least 30 days prior to Screening
* NYHA class II to IV at the time of Screening
* LV hypertrophy, by echo within 6 months of screening, defined by either LV mass/BSA \>95 g/m² for females and 115 g/m² for males or LV mass/m² for males \>44 g/m2.7 for females and 48 g/m2.7 for males
* NT-proBNP criteria either ≥300 pg/mL if in sinus rhythm or ≥700 pg/mL if in atrial fibrillation at screening
* Elevated LV filling pressure criteria are defined as ONE OR MORE of the following:

  1. HF hospitalization within 12 months prior to screening
  2. LA enlargement (LA width (diameter) ≥3.8 cm, LA length ≥5.0 cm, LA area ≥20 cm² , LA volume ≥55 mL, or LA volume index \>29 mL/m²) within 6 months of screening for a participant in sinus rhythm
  3. Cardiac catheterization with at least one of the following in the 12 months prior to screening: rest LVEDP or PCWP ≥15 mm Hg, exercise PCWP ≥25 mm Hg, or fluid challenge PCWP ≥18 mm Hg
  4. Echocardiogram criteria of one or more within 6 months of screening for a participant in sinus rhythm: E/e' (mean of lateral and septal) \>13, E/e' lateral \>12, or E/e' septal \>14; or for a participant in atrial fibrillation: E/e' septal \>11
* For WOCBP: Two negative pregnancy tests and the use of highly effective contraception up to 3 months following end of study

Exclusion Criteria:

* Any prior echocardiographic imaging measurement of LVEF \<40%
* Six-minute walk test (6MWT) distance \<100 m or \>450 m at Screening Visit
* Kansas City Cardiomyopathy Questionnaire (KCCQ) overall summary score of \>80
* Major cardiovascular surgery, or urgent percutaneous coronary intervention (PCI) within the 3 months prior to Screening Visit, or an elective PCI within 30 days prior to Screening Visit
* Any clinical event within 6 months prior to Screening Visit that could have reduced the LVEF (eg, myocardial infarction, coronary artery bypass graft) unless an echocardiographic measurement was performed at least 1 month after the event confirming the LVEF to be ≥45%