cyrilzakka/clinical-trials huggingface dataset:
The Effects of Music Therapy as a Complementary Intervention in the Treatment of Pediatric Asthma

The onset of asthma is particularly frightening for children. When the symptoms of asthma decrease, children and parents forget about the maintenance and control of breath and lung volume. Because adherence is so poor, asthma is known as the emergency room illness. The playing of a wind instrument is a unique way to provide a creative means for children and teens to understand both the impact of diaphramatic breathing and their ability to control it as well. This study builds upon the evidence, though sparse, that suggest that the blowing of a wind instrument with clinical music therapy intervention strengthens the muscles of breathing and fortifies the incentive toward attending to the daily symptoms and general management of asthma.


Eligibility Criteria:
Inclusion Criteria:

* between the ages of 7 and 18
* diagnosed with asthma

Exclusion Criteria:

* over 18
Study of Neural Responses Induced by Antidepressant Effects

The proposed work aims to examine the neural changes associated with fast-acting antidepressant treatments in order to develop imaging-based biomarkers of treatment response for depression.

Over the past decade, neuroimaging tools have rapidly advanced the field of neural biomarkers of treatment response in depression. Still, despite obvious scientific progress in this field, the ability to implement neuroimaging biomarkers of antidepressant treatment response in clinical trial settings is lacking. In order to objectively assess the neural bases of treatment response in depression, the investigators will use a "Real-time Neurofeedback fMRI task", specifically designed to record and modulate mood improvement by providing neurofeedback in the context of the administration of an antidepressant treatment. In a pilot study, positive neurofeedback during the administration of the drug was associated with significant acute mood improvement and increased blood oxygen level dependent (BOLD) responses in the rostral anterior cingulate cortex (rACC), a common neural target of antidepressant treatments. The central hypothesis is that antidepressant effects in depression are mediated by increased neural activity in the rACC (AIM1), which can be used in clinical trials of antidepressant treatment to predict antidepressant effects (AIM 2) and assess the effect of antidepressant treatment on antidepressant-induced rACC neural responses (AIM 3). The results obtained from this project are expected to have an important impact on our ability to understand the cognitive and neural mechanisms implicated in antidepressant treatment responses in patients with depression, as well as on the ability to implement neuroimaging biomarkers of treatment response in the clinical trial settings.

Eligibility Criteria:
Inclusion Criteria:

* A man or woman age of 18 or older.
* Currently experiencing a depressive episode as part of Major Depressive Disorder.
* Able to tolerate lying still on your back for 60 minutes at a time.
* Have had no more than one failed antidepressant trial of adequate dose and duration.
* Have been antidepressant medication-free for at least 21 days prior to collection of imaging data (5 weeks for fluoxetine)

Exclusion Criteria:

* Are currently taking any psychiatric medication, or any potentially augmenting or sedative drugs.
* Have a history of inadequate response/tolerability to escitalopram; or history of resistant depression
* Pregnant or breastfeeding or plan to become pregnant over the duration of the study.
* Have a history (lifetime) of psychotic depressive, schizophrenic, bipolar, schizoaffective, or other Axis I psychotic disorders.
* Meet criteria for substance dependence in the last 6 months, except nicotine, or substance abuse in the last 2 months.
* Have a medical condition that contradicts treatment with escitalopram.
* Are currently receiving psychotherapy or any other treatment for your depression.
Portable Monitoring Device for the Diagnosis of Sleep Apnea in Obese Patients

Introduction The portable monitoring system (PMS) recording of cardiopulmonary parameters (level III of ASDA) has been validated in subjects with high probability of Obstructive Sleep Apnea (OSA) without comorbidities.

However, there is not any study evaluating this system when OSA is associated with morbid obesity, so the validation of PMS will be very useful in order to properly work-up this highly risk population.

Objective:

To evaluate the accuracy of level III type of PMS - Stardust™" (STD), on patients with level II and III of obesity and high clinical suspicion of OSA.

Methods:Participants with BMI \> 35 kg/m2 and with suspicion of OSA will consecutively be selected from an Outpatients Sleep Clinic of UNIFESP. They will be randomized for the following order of recordings:

1) STD at home for 1 night 2) STD in the sleep lab simultaneous to PSG. AHI will be taken for subsequent analysis:a) AHI PSG b) AHI STD -lab and c) AHI STD- home.


Eligibility Criteria:
Inclusion Criteria:

* BMI \> 35
* Complaints of snoring, sleep apnea, daytime sleepiness

Exclusion Criteria:

* use of home oxygen
* other sleep diseases
* inability to perform PSG
Contribution of a Nurse Consultation in the Follow-up of At-risk Newborn at Maternity Discharged

The postnatal period is a critical phase involving important physiological, psychological and social changes. Pediatric nurses could be a crucial actor in the follow-up of at-risk newborn, in collaboration with other health professionals and contribute to a reduction in pediatric emergency department (PED) visits and/or hospitalization in first weeks of life. To describe population of at-risk newborns who attended a nurse consultation after discharge from a type 3 maternity hospital and to evaluate the impact of a post-hospitalization nurse consultation for at-risk newborns on PED visits and hospitalizations.

The postnatal period is a critical phase involving important physiological, psychological and social changes. In 2013, WHO recommends at least three postnatal contacts on day 3, between days 7 and 14, and six weeks after birth. Despite these recommendations, pediatric emergency department (PED) visits for newborns are constantly increasing. Some studies have shown that most of these visits were related to nonserious diseases, mainly due to a lack of knowledge and information. At the same time, some high-risk newborns have been identified as likely to be admitted to PED and subsequently hospitalized. All these findings highlight the great need for education and parental support by health staff from the time of maternity discharged, particularly when certain high-risk conditions are identified.

In France, guidelines on maternity discharge after childbirth include pediatric nurses as professionals involved in postnatal follow-up. Pediatric nurses could be a crucial actor in the follow-up of at-risk newborn, in collaboration with other health professionals and contribute to a reduction in PED visits and/or hospitalization in first weeks of life.

Eligibility Criteria:
Inclusion Criteria:

* All at-risk newborns addressed to nurse consultation after discharge from maternity hospital.
* All at-risk newborns discharged home after hospitalization at birth in the neonatal medicine department.

Exclusion Criteria:

* Newborns discharged with home hospitalization
* Consultation for hearing screening, blood testing or injection (vaccines or palivizumab).
* Newborns referred by pediatrics department, PED or by exterior professionals.
* Non-at-risk newborns hospitalized for other reasons (biological anoxia, early neonatal bacterial infection, transient tachypnea, monitoring)
Translating a Dementia Caregiver Intervention Into a Mobile Application

The overall goal of this development project is to combine elements of two efficacious interventions into a mobile health (mHealth) App for informal dementia caregivers. The investigators will conduct a 3-month feasibility trial of the newly-developed CARE-Well App in 40 dementia caregivers to establish acceptability and feasibility of the intervention, study procedures, and outcome measures.

Caring for a person with dementia is a highly stressful activity and is associated with negative physical and mental health consequences, including increased risk of depression and worse reported health-related quality of life. The proposed project aims to develop and translate an evidence-based, multi-component intervention into a mHealth App that has the potential to increase dementia caregivers' access to support and care.

The investigators will conduct a feasibility trial, in which 40 dementia caregivers will be randomized to receive a computer tablet preloaded with the CARE-well App or preloaded with internet links relevant to dementia and caregiving. Paper outcome measures will be assessed at baseline and end of intervention (3 months) during each study visit. To measure sustainability of the App, the first 10 caregivers from each group will be offered the tablets for an additional month to monitor usage of the App outside the formal trial. The goal of this aim is to determine feasibility of the intervention, study procedures, and outcome measures.

Eligibility Criteria:
Inclusion Criteria:

* Adequate English-speaking and reading skills
* Provide at least 4 hours of supervision per day for the care recipient (either directly or by telephone)
* Live in the community (either with the care recipient or without)
* Have provided supervision/ assistance for at least 6 months prior to study enrollment and have no plans to place care recipient in long term care or to end their role as caregiver within 6 months of study enrollment.
* Report some degree of distress associated with caregiving
* Access to Wifi at home

Exclusion Criteria:

* Major acute medical illness
* Severe mental illness (e.g. bipolar, schizophrenia)
* Diagnosed cognitive impairment
Tobacco-Focused Patient Navigation to Address Barriers to Utilization of Community-Based Smoking Cessation Services in Primary Care

Patient navigators have been shown to assist people seeking cancer screening and other medical services. The purpose of this study is to see whether a patient navigator can link smokers to available community resources shown to help smokers quit smoking.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Self-reported current daily smoker, as verified with a portable alveolar carbon monoxide (CO) analyzer (24 hour point prevalence); CO levels ≥ 8 ppm.
* English and/or Spanish-speaking
* Referred to the navigation program by their primary care clinician
* At baseline, participants report at least thinking about quitting (i.e., Contemplation or Preparation stages of readiness to quit).

Exclusion Criteria:

* Serious, untreated psychiatric illness (e.g., schizophrenia,) or active substance abuse likely to preclude adherence to the protocol
Cotinine Feedback as an Intervention to Change Parental/Caregiver Smoking Behavior Around Children With Cancer

RATIONALE: Providing parent/caregivers of children with cancer with education and evidence of secondhand smoke exposure can protect the child from future exposure to tobacco smoke.

PURPOSE: This randomized study will compare education only to education plus cotinine feedback in decreasing secondhand smoke exposure in pediatric patients with cancer that reside with a household smoker.

OBJECTIVES:

The primary objective of this study is to determine if providing urine cotinine feedback to caregivers in conjunction with standard education will be more effective than education alone in reducing patient SHS exposure.

The secondary objectives of this study are:

To determine whether urine cotinine feedback in conjunction with education provided to the caregiver is more effective in changing parental smoking behavior compared to education alone.

As an exploratory measure we will collect history and physical exam data to follow patient's clinical complications during the study to determine if patients with a decrease in SHS exposure also have a decrease in clinical complications.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 2 years and ≤ 12 years at the time of study entry.
* Currently undergoing treatment for cancer at the time of enrollment, at least 28 days post diagnosis.
* The child must reside 5 days a week with a household smoker (defined as a person who smokes greater than 10 cigarettes daily).
* Child must be potty trained.
* Parent/Legal Guardian ≥ 18 years of age.
* Parent/Legal Guardian who accompanies the child to the first visit must accompany the child to all other visits. This person does not need to be the household smoker, but must be willing to educate the smoker on results at the visit and take the education handout home to them.
* Parent/Legal Guardian must have a working phone to complete the week 5 follow-up phone call.
* Able and willing to sign informed consent/assent.
* Signed HIPAA compliant research authorization.

Exclusion Criteria:

* Planned hospitalization within 3 days of any scheduled study visit (due to the urine cotinine measurement representing the previous 48-72 hours of tobacco exposure.
* Inability to perform the initial cotinine test.
Safety and Efficacy of Gardasil in Females With Juvenile Idiopathic Arthritis (JIA)/Seronegative Arthritis

The purpose of this research study is to see if patients with juvenile idiopathic arthritis or seronegative arthritis (and related conditions) mount protective immune responses to the human papillomavirus (HPV) vaccine called Gardasil. The researchers also want to monitor for any increase in disease activity following receipt of the vaccine.

Each individual subject's participation is scheduled to last approximately two years. Patients will be given Gardasil injections at months 0, 2, and 6. Patients will have geometric mean titers (GMT) measured at 7, 12, and 24 months. Questionnaires about health and function will also be completed at each visit.

Eligibility Criteria:
Inclusion Criteria:

* Female patients, age 9-26 years, with polyarticular JIA, pauciarticular JIA, and sero-negative arthritis.

Exclusion Criteria:

* Pregnancy
* Known allergy/sensitivity or any hypersensitivity to yeast or components of study drug or their formulation
* Systemic onset JIA with active systemic symptoms (systemic onset JIA with polyarticular features but no fever or rash may be included).
* Prior vaccination against HPV
* Known HPV infection
* Current or history of cervical cancer or cervical intraepithelial neoplasia (CIN).

Males are excluded from this study because Gardasil® is currently approved only for females.
A Study of Capecitabine (Xeloda) as First-Line Chemotherapy in Participants With Metastatic Nasopharyngeal Cancer

This study will evaluate the efficacy, safety, tolerability, and effect on quality of life of oral capecitabine in combination with intravenous (IV) cisplatin in participants with metastatic nasopharyngeal cancer. Participants will receive up to 8 cycles of capecitabine treatment, and cisplatin will be administered on the first day of each cycle. The anticipated time on study treatment is up to 24 weeks, and the target sample size is 44 individuals.


Eligibility Criteria:
Inclusion Criteria:

* Adults 18 to 75 years of age
* Histologically confirmed, poorly differentiated or undifferentiated metastatic nasopharyngeal cancer with at least 1 measurable lesion which has not been irradiated
* Ability to swallow and retain oral medication

Exclusion Criteria:

* Previous cytotoxic chemotherapy except adjuvant, concurrent, or neoadjuvant treatment completed at least 6 months before enrollment
* Clinically significant cardiac disease
* History of other malignancy within the last 5 years except cured basal cell cancer of the skin or cured cancer in situ of the cervix
* Radiotherapy within 4 weeks of treatment start or any prior radiotherapy performed to the indicator lesion(s) being measured in the study
OptimizeD Pilot Study

This pilot study aims to explore and refine the trial procedures that will be implemented in a larger-scale clinical trial scheduled to commence in March 2024 (NCT05944926). As part of this study, 60 patients with moderate to severe depression will be randomized to either psychotherapy based on behavioral activation called the Healthy Activity Program (HAP) or antidepressant medication.

The pilot study has two primary objectives:

1. Evaluate the feasibility and acceptability of the study
2. Collect essential outcome data in preparation for the larger trial

This pilot study will play a pivotal role in preparation for the forthcoming larger clinical trial, named the OptimizeD study, scheduled for launch in March 2024 (NCT05944926).

The primary objective of the OptimizeD study is to explore whether different patients respond differentially to a brief psychological treatment, known as the Healthy Activity Program, or a widely used generic Selective Serotonin Reuptake Inhibitor (fluoxetine). If such differences exist, this study aims to explore whether one can develop a machine learning-generated precision treatment rule to predict the most effective treatment based on individual baseline characteristics.

The pilot study has two primary objectives:

1. Evaluate the feasibility and acceptability of the study:

   This pilot study will focus on assessing the feasibility and acceptability of the research protocol, including recruitment strategies, data collection methods, interventions, and risk management procedures. This evaluation will help refine and tailor the study procedures and play a critical role in setting the stage for the subsequent OptimizeD study.
2. Collect essential outcome data in preparation for the larger trial:

This study will test and refine the data instruments, gather initial data on efficacy, and refine the baseline assessment (which will serve as the cornerstone for the development of the precision treatment rule).

Eligibility Criteria:
Inclusion Criteria:

* Participants will be adults aged 18 or over of any gender attending one of eight Primary Health Care Centers with a "diagnosis" of moderate to severe depression based on scores of 10 or above on the Patient Health Questionnaire-9 (PHQ-9).

Exclusion Criteria:

* Women who are pregnant or are breastfeeding or lactating
* Patients with a history of psychosis including schizophrenia spectrum disorders or bipolar disorder.
* Participants planning to move out of the study area during the follow-up period.
* Patients over 65 years of age with evidence of cognitive impairment - Patients who do not speak the study or local language (English or Hindi)
* Patients who are undergoing treatment for depression at the time of recruitment
LUCID - LUng Cancer CIrculating Tumour Dna Study

This is a prospective observational pilot study to investigate levels of circulating tumour DNA (ctDNA) in plasma from patients with stage I to IIIB non-small cell lung cancer (NSCLC) who will undergo treatment with curative intent.

Taking as reference tumour-specific somatic genetic alterations identified within individual cancer biopsies from patients, recent advances in genomic and next generation sequencing technologies now provide the opportunity to investigate whether each patient's tumour-specific DNA can be reliably detected within their plasma. This offers the possibility to test a patient's response following treatment with curative intent. This technology has already been used to detect ctDNA in metastatic NSCLC, but not yet in early stage disease.

The primary objective of this pilot study is to test the feasibility of detecting serial ctDNA levels in stage I to IIIB NSCLC patients who undergo treatment with curative intent. As secondary endpoints, this study aims to measure ctDNA levels and characteristics, and to correlate them with clinical features (such as burden of disease and treatment response) in order to test the value of ctDNA as a diagnostic, prognostic and predictive biomarker for patients with NSCLC.

100 patients planned for curative treatment (surgery or radical radiotherapy +/- chemotherapy) will be recruited.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years old at the time of consent
* Male or Female
* Patients with radiologically and histologically/cytologically confirmed stages I to IIIB NSCLC who are planning to undergo radical treatment (surgery or radical radiotherapy) with curative intent
* ECOG Performance Status 0-2
* Able to give informed consent
* Able to give blood

Exclusion Criteria:

* Unable to receive treatment with curative intent due to co-morbidity or personal choice

Patients participating in other clinical studies are not precluded from entering the study; however they must meet all the eligibility criteria for this study.
Investigation Of The Effects Of Kegel Exercises On Vaginal Flatus Among Postpartum Women

Title: Investigation of the Effects of Kegel Exercises on Vaginal Flatus Among Postpartum Women

Brief Summary:

This study aims to evaluate the effectiveness of Kegel exercises in reducing vaginal flatus among postpartum women. Vaginal flatus, the involuntary passage of air through the vagina, is a common but often underreported pelvic floor dysfunction that can affect women's quality of life.

A total of 40 postpartum women were randomly assigned to an experimental group (performing Kegel exercises) or a control group (no intervention). The experimental group performed Kegel exercises three times daily in different positions for six weeks. Vaginal flatus frequency and bother scores were assessed using a validated questionnaire, and sexual quality of life was evaluated with the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).

This study is a randomized controlled trial designed to assess the effectiveness of Kegel exercises in reducing vaginal flatus among postpartum women. Vaginal flatus, the involuntary passage of air through the vagina, is a common but often overlooked pelvic floor dysfunction that can negatively impact women's quality of life.

A total of 40 postpartum women were recruited and randomly assigned to either the experimental group, which performed Kegel exercises, or the control group, which received no intervention. Participants in the experimental group were instructed to perform Kegel exercises three times daily in different positions (supine, sitting, and standing) over six weeks. The intervention focused on strengthening the pelvic floor muscles through a combination of fast and slow contractions targeting both Type I and Type II muscle fibers.

The primary outcome measures included vaginal flatus frequency and bother scores, which were assessed using a validated questionnaire before and after the intervention. Additionally, sexual quality of life was evaluated using the Pelvic Organ Prolapse/Urinary Incontinence Sexual Questionnaire (PISQ-12).

Eligibility Criteria:
Inclusion Criteria:

* being between the ages of 20-50,
* being postpartum at least 6 weeks after the last birth,
* having a complaint of vaginal flatus, and being willing to exercise

Exclusion Criteria:

* being over four months postpartum,
* current pregnancy,
* presence of pelvic infection,
* inability to indicate whether there is vaginal flatus,
* the presence of gynecological cancer.