cyrilzakka/clinical-trials huggingface dataset:
Rural Disparities in Pediatric Obesity: The iAmHealthy Intervention

The purpose of this study is to learn if providing a family-based group program using mobile health technology (iAmHealthy Healthy Lifestyles Program) is effective at improving child weight, nutrition, and physical activity.

This is a cluster-randomized study that will test the iAmHealthy Healthy Lifestyles Program versus a standard approach to weight loss in kids current in 2nd thru 4th grade. The iAmHealthy Healthy Lifestyles Program utilizes mobile tools to deliver the weight loss program to kids and families in rural settings. This study will include kids from schools in rural cities/counties, and their parents, and they will be randomly assigned to a group by their school.

The iAmHealthy Healthy Lifestyles Program is a rurally tailored telemedicine intervention. It delivers behavioral, nutritional, and physical activity topics for kids and their families. The total length of the intervention will be about 8 months, which coincides with the length of a typical school year.

Eligibility Criteria:
Inclusion Criteria:

* Family lives in a rural area (city and/or county population less than 20,000)
* Child Body Mass Index (BMI) \>85th and \<99th percentile
* Child in 2nd thru 4th grade
* Child and Parent speak English
* Family is available at times intervention is offered

Exclusion Criteria:

* Child has physical limitation or receives an injury which significantly limits physical mobility
* Child has significant medical issue
* Child and Parents have significant developmental delay or cognitive impairment
* Child has a sibling who has already enrolled in the program
* Family moves to a non-participating school
Therapeutic Exercise Training in the Elderly

In adulthood, limited mobility and pain are very common and often the first clear sign of functional decline. The loss of independent mobility is related to higher rates of functional disability and mortality; however, it is also susceptible to interventions through exercises. With aging, changes in peripheral and central nervous system also occur, which lead to degradation of the sensory receptors as well as a loss of muscle mass and coordination. However, both, structural and functional dysfunctions of the nervous system, can be mitigated by increasing physical activity.

The aim of this study is therefore, to study the effects on pain and functional capacity of a therapeutic exercise training program in an adult people sample. The therapeutic exercise machines proposed in this trial have not been previously analyzed and provide insight into this field due to their design. The design of this new machines allows the adaptation to each concrete clinical situation by the adjustment of different parameters such as feedback, range of movement, time of repetition, intensity, speed and rhythm, which facilitate motor control training.


Eligibility Criteria:
Inclusion Criteria:

* Ability to complete self-reported questionnaires
* Autonomous ambulation that allows the realization of functional test
* Accept and consent to voluntarily participate in the study
* Preclinical mobility restriction and/or pain in absence of important pathologies.

Exclusion Criteria:

* Present contraindications for physical exercise
* Receiving physiotherapy treatment during the time of the trial.
* Modification of physical habits
* Change the pattern or usual pharmacotherapy
Impact of Nicotine Messaging on Nicotine Beliefs and Tobacco Use Behavior

This is a 2-arm, randomized controlled, population based trial to test the impact of multiple exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and non-smokers followed in waves over 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the same time points include intention to use nicotine/tobacco products and nicotine/tobacco use.

This is a 2-arm, randomized controlled, population based trial to test the impact of multiple exposures to brief nicotine corrective messages among adult tobacco cigarette smokers and non-smokers followed for 12 weeks. The primary outcome, assessed at wave 1 (baseline), wave 2 (weeks 5-6), and wave 4 (weeks 11-13) is nicotine beliefs. Secondary outcomes assessed at the same time points include intention to use nicotine/tobacco products and nicotine/tobacco use. All participants will be recruited from a US national consumer research panel. Eligible participants will be U.S. adults ages 18+ who are enrolled members of the partnering consumer research panel. The sample will include non-smokers and smokers, oversampling current smokers (defined as smoking 100+ lifetime cigarettes and now smoking all or some days) to ensure the proportion of smokers in the sample reflects the \~15 % population smoking prevalence among adults. Panel members will be contacted by email with a brief study description and link to an eligibility screener and online informed consent form. Eligible and interested participants will complete the baseline (Wave 1) survey measures of nicotine beliefs and intentions/use of nicotine and tobacco products, after which they will be randomly assigned in equal numbers to the nicotine corrective message (NCM) intervention condition or the delayed message control condition. After completing the baseline survey, participants in the NCM condition will receive their first exposure to the corrective messages. In the Wave 2 survey, all participants will complete measures of nicotine beliefs and intentions/use of nicotine and tobacco products. Participants in the NCM condition will then receive their second exposure to study messages. Only participants in the NCM condition will receive the Wave 3 survey, which involves the third exposure to study messages. The Wave 4 survey will include the fourth exposure to study messages for those in the NCM condition and the final assessment of nicotine beliefs and intentions/use of nicotine and tobacco products for all participants. Upon completion of the final assessment, participants in the control condition will be exposed to the nicotine corrective messages and all participants will be directed to resources on quitting smoking.

Eligibility Criteria:
Inclusion Criteria:

* US resident age 18+
* Member of the partnering consumer research panel conducting the survey
* Non-smokers and tobacco cigarette smokers

Exclusion Criteria:

* Age less than 18
* Not a member of the partnering consumer research panel conducting the study
Dolutegravir/Rilpivirine, Antiretroviral Efficacy Study Using Real-world Data in Subjects With Human Immunodeficiency Virus (HIV)-1

This was a prospective, non-interventional, single-arm, multi-center study aimed at gathering real-world data on JULUCA use in routine clinical care in Germany, to supplement clinical trial data to further improve/optimize care in HIV positive participants in Germany. Approximately 250 virologically suppressed HIV positive participants on stable antiretroviral therapy (ART) were included in the study at the discretion of treating physician. Eligible participants were followed up for approximately 3 years and data was collected during routine clinical care.


Eligibility Criteria:
Inclusion Criteria:

* Greated than or equal to (\>=)18 years of age.
* Documented HIV-1 infection.
* Virologically suppressed (HIV-1 ribonucleic acid \[RNA\] less than \[\<\] 50 copies \[c\]/mL for at least 6 months)
* Prescription for JULUCA was issued independently from entering this study.
* Ability to understand informed consent form and other relevant study documents

Exclusion Criteria:

* Any contraindication according to JULUCA SmPC.
* Documented viral load greater than (\>) 50 c/mL at any time point within 6 months prior to inclusion into this study.
* History of treatment failure.
* Known or suspected substitutions associated with resistance to any non-nucleoside reverse-transcriptase inhibitors (NNRTI) or integrase strand transfer inhibitor (INSTI).
* Any ART for the treatment of HIV-1 in addition to JULUCA.
* Hepatitis B virus (HBV)-co-infection.
* Current participation in the ongoing non-interventional study TRIUMPH (study number: 202033) or any interventional clinical trial irrespective of indication.
* Previous participation in clinical trials involving JULUCA.
Questionnaires to Identify Chinese Patients at Risk for Obstructive Sleep Apnea

The purpose of this study is to validate the Berlin questionnaire and STOP-BANG (snore, tired, obstruction, pressure, body mass index (BMI), age, neck, gender) as effective screening tools for Chinese subjects who are suspected to have obstructive sleep apnea (OSA).

Obstructive sleep apnea (OSA) is a common sleep related breathing disorder associated with excessive daytime sleepiness and cardiovascular disease. It is prevalent in both western (4-26%) and eastern countries (4-19%). In recent studies, it has been estimated that at least 70-80% of middle aged individuals with sleep apnea are undiagnosed and untreated. The prevalence of undiagnosed OSA subjects within the community suggests the need for a greater awareness and a high index of suspicion of this disease entity as well as its associated short- and long-term comorbidities.

A reliable and easy-to-use screening questionnaire is required for efficient prediction of OSA and treatment arrangement. It would be helpful to prioritize patients who require sleep study according to the probability of suffering from sleep apnea. It reduces the use of sleep study for those with low probability of having OSA, but giving treatment to those who are with more severe OSA first. Meanwhile, it enhances the cost effective management of disease especially with limited resources in our society.

Eligibility Criteria:
Inclusion Criteria:

a. No known history of any sleep disorder

Exclusion Criteria:

1. History of heavy alcoholism ( ≥ 3 times / week)
2. Underlying pulmonary diseases
3. Recent upper respiratory tract infection in the past one week
4. Unstable medical conditions
5. Pregnancy
6. History of psychiatric illness
Pharmacist for Detecting Opioid Misuse

Opioid use is increasing in Western countries and is associated with harms as hospitalization, addiction and deaths(1). Community pharmacists interact frequently with patients, giving them the opportunity to identify and prevent the risk of prescribed opioid misuse. The purpose of this study was therefore to assess the risk of prescribed opioids misuse in ambulatory patients with chronic non-cancer pain (CNCP) seen in community pharmacies.

Method: A questionnaire (including the Prescription Opioid Misuse POMI(2)) have been proposed to patients with opioid prescription by pharmacy students, in 86 pharmacies of Occitanie-Est, in April 2019. Eligible patients were adults with CNCP that consented to participate.

A total of 414 patients (62.4% women, mean age 58 ± 16.00) have been included. The main pains were spinal (37.3%) and osteoarticular (33.1%). The median visual analog scale (VAS) was 7 \[IQR25-75: 5-8\]. The prescribed opioids are mainly weak opioids (73.2%): paracetamol/tramadol (35%), paracetamol/codeine (17.4%), paracetamol/opium (16.8%). Strong opioids (32.6%) were oxycodone (11.95%), fentanyl (9%), and morphine (9%). The median morphine milligram equivalent (MME) was 40 mg/day \[IQR25-75: 20-80\].

POMI score was superior to 2/6 in 45.4% and superior to 4 in 16%. The main positive question were feel high (40.3%), take the opioid more often (39.3%), take more medication (36.6), and need to early renew opioid medication earlier (30.8%).

Patients with POMI score \> 4 were younger (49 years versus 55.9; p\<0.01), more urban (78.1% versus 69.2%; p=0.03), had higher VAS (7.3 versus 6.2; p\<0.01), received higher median MME (112 mg versus 64.9 mg; p\<0.01), and consumed more strong opioid (45.3% versus 27.3%; p=0.04).


Eligibility Criteria:
Inclusion criteria:

* -Collection of the questionnaire in a community pharmacy of the area of investigation East-Occitania)
* Patient over 18 years of age
* Suffering from pain (CNCP) (\> 3 months old)
* Treated with weak or strong opioids

Exclusion criteria:

* Collection of the questionnaire in a community pharmacy outside Eastern Occitania
* Patient under 18 years of age
* Suffering from acute pain (\< 3 months old) or cancerous pain
Eustachian Tube Testing in a Pressure Chamber -- Validation Study

This study will compare Eustachian tube function (ETF) testing in adults with intact tympanic membranes (TM) using a pressure chamber to that obtained using standard methods requiring a non-intact TM.

The investigators propose to introduce new test methods and protocols to our laboratory for better clinical characterization of Eustachian tube function in ears with intact TM's. These test will be done in a pressure-chamber and will use previously published and newly developed methods. Participation will require a minimum of 5 visits to the ENT Research Center, 1 for myringotomy (putting a small hole in the eardrum) and 4 for ETF testing. Hearing testing will be done at entry and exit; otoscopy (looking at the ears) and tympanometry (a test done with an earplug and varying pressures in the ear canal) are done at every visit.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years old
* Normal middle-ear status

Exclusion Criteria:

* Chronic illness including asthma, pulmonary, or cardiac problems
* Pregnancy
* \>10 dB hearing loss in any of the speech frequencies
* Past history of sensitivity or allergic reaction to lidocaine or related compounds
Interest of High-throughput Sequencing of RNAs for the Diagnosis of Heterogeneous Genetic Diseases

The advent of high throughput genomic DNA sequencing has led to major advances in the diagnosis of genetic diseases of heterogeneous origin. Thus, our hospital laboratory has developed in recent years several diagnostic tests based on the targeted sequencing of coding sequences of gene panels (from about twenty genes for DNA repair diseases to nearly five hundred genes for the intellectual disability). These targeted analyzes, carried out by capture, have thus solved 25 to 80% of the cases according to the indications, without allowing the diagnosis of the totality of the patients.

For these negative cases, the search for mutations in the coding sequences was then extended to Whole Exome Sequencing, thus providing several additional diagnoses.

Patients still remain without diagnosis after this exome study. These could be complex cases of genetic or even non-genetic origin, but also monogenic pathologies linked to mutations that are not identifiable by coding sequence analyzes, and especially affecting messenger RNAs.


Eligibility Criteria:
Inclusion criteria common to all participants:

* Patient minor or major
* Patient suffering from a pathology studied in the laboratory by high throughput sequencing: intellectual disability, myopathies, neurosensory disease (Bardet-Biedl syndrome, retinitis pigmentosa, ....), DNA repair diseases (Cockayne syndrome, ...)
* Sampling allowing the extraction of available RNA (or RNA available in the bank)
* Patient (or its legal representative) having already given their consent, on the one hand for carrying out genetic analyzes to determine the cause of their disease, and on the other hand for the conservation of part of their non used for further use in order to continue diagnostic investigations in the light of evolving knowledge and for research purposes.
* Patient (or its legal representative) agreeing to use data from his medical file and those associated with genetic diagnosis for research purposes
* Patient affiliated to a social security scheme Inclusion criteria for the test phase
* Pertogenous mutation (s) known Inclusion criteria for the prospective phase
* Magnetic molecular diagnosis, after the usual investigations (high-throughput sequencing of a panel of genes on genomic DNA, sequencing of exome, or even genome.

Non-inclusion criteria:

◾ Refusal of the patient (or his / her legal representative) to participate in the study.
Donor Neutrophil Subsets to Predict the Risk of aGVHD

This is a prospective study to explore the association between donor neutrophil subsets and acute graft-vs.-host disease outcomes. Approximately 260 subjects (including 130 donors and 130 corresponding recipients) will be recruited.

This study was a single-center, observational, prospective cohort study. The study lasted for 3 months, from 2023.12 to 2024.3, the clinical enrollment was completed, and from 2024.3 to 2024.6, the follow-up was completed. It is planned to enroll 260 subjects, divided into 130 donors and 130 patients.

No randomization or any protocol-driven treatment will be performed or provided to subjects during the course of the study. Treatment decisions and selection of treatment options are left to the discretion of the treating physician, if clinically appropriate.

All recipients will be followed for aGVHD evaluation, relapse, cGVHD, leukemia relapse, disease-free survival (DFS), non-relapse mortality (NRM). aGVHD and cGVHD were graded according to published guidelines. All recipients will be monitored every month until the study is completed.

Eligibility Criteria:
Inclusion Criteria:

Donors

1. Voluntarily sign the informed consent form;
2. Age 16-65 years old
3. Donors whose HLA-matched or HLA-mismatched to the corresponding recipients

Recipients

1. Voluntarily sign the informed consent form
2. Age 16-65 years old
3. Willing to undergo HLA-matched or HLA-mismatched allo-HSCT

Exclusion Criteria:

Donors

1. Have a history of other tumors
2. With poor compliance or mental disorders
3. Infected with HIV and HCV
4. With uncontrolled HBV infection
5. With other autoimmune diseases
6. Those who are judged by the researcher to be unsuitable to participate in this study

Recipients

1. Have a history of other tumors
2. With poor compliance or mental disorders
3. Infected with HIV and HCV
4. With uncontrolled HBV infection
5. With other autoimmune diseases
6. Those who are judged by the researcher to be unsuitable to participate in this study
S9346A Blood Samples From Patients With Metastatic Prostate Cancer Previously Treated With Bicalutamide and Goserelin

RATIONALE: Studying samples of blood in the laboratory from patients with cancer may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors predict how patients will respond to treatment.

PURPOSE: This research study is studying blood samples from patients with metastatic prostate cancer previously treated with bicalutamide and goserelin.

OBJECTIVES:

* To test the association between serum PSA response (\< 4 ng/mL) at 7 months with inherited variability of germline single nucleotide polymorphisms, in a set of candidate genes, in patients with metastatic prostate cancer treated with combination induction androgen-deprivation therapy comprising bicalutamide and goserelin.

OUTLINE: DNA extracted from whole blood or serum samples is analyzed for inherited variability of germline single nucleotide polymorphisms.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosed with metastatic prostate cancer
* Accrued to SWOG-9346 and received androgen-deprivation therapy (ADT)
* Must have serum PSA values from the beginning to the end of 8 courses of ADT
* Must have whole blood or serum samples available

PATIENT CHARACTERISTICS:

* Caucasian and African-American participants

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Segmental Trunk Stability Training on Sitting and Upper Limbs Functions in Children With Spastic Cerebral Palsy

The study aims to:

1. Investigate the effect of segmental trunk stability training on sitting in children with spastic CP.
2. Investigate the effect of segmental trunk stability training on upper limbs functions in children with spastic CP.

Postural dysfunction is one of the most limiting factors in children with CP. It restricts reaching skills and in turn reduces participation in activities of daily living.

The trunk plays a key role in maintaining the postural control mechanism and also in the organization of balance reactions in this developmental process. The trunk control is also required for a stable base of support which is necessary to execute functional activities for limb movements.

The optimal level of trunk support for a child with spastic CP still remains unknown. Thus, providing intermediate levels of trunk stabilization would be a better solution than providing full support in children with CP. Innovation is necessary to improve outcomes for children with moderate to- severe CP who are at level IV and V on GMFCS. However, these children are often excluded from posture research . Very little research has examined postural constraints in children with moderate-to-severe CP.

As there is a lack of tools used in precise trunk stabilization during training, a further researches are needed. Recently, a special attention has been given to the segmental trunk control and its effects on improvement of gross and fine motor skills. Most of previous studies have been applied during segmental fixation of the trunk at multiple levels from static position either sitting or standing. In the present study, the effect of external segmental stabilization of the trunk at selected parts will be monitored during the active training and participation of the child.

Eligibility Criteria:
Inclusion Criteria:

1. Children with spastic CP, their chronological age will be ranged from 2 years to 4 years.
2. Their level of motor function will be 4 or 5 according to Gross Motor Function Classification System - Expanded and Revised
3. The degree of spasticity for these children will ranged from grade 1 to 2 according to Modified Ashworth Scale
4. All children's level of segmental trunk control will be level 3 according to Segmental Assessment of Trunk Control
5. They will be able to follow instructions during evaluation and treatment.

Exclusion Criteria:

* Any child with the following criteria will be directly excluded from the evaluation for the consistency of the sample and statistically obtained results: 1. Surgical interference in upper limbs and/or spine that may restrain the child performance during activities.2. Orthopedic problems or fixed deformities in the vertebral column and/or upper extremities. 3. Uncontrolled seizures. 4. Visual or hearing impairment.