cyrilzakka/clinical-trials huggingface dataset:
Effect of Strength and Coordination Training on Biomechanics and Injury in New Runners

The investigators hypothesize that new runners participating in an 8 week strength and coordination training program prior to beginning to run will 1) display different coordination patterns , and 2) experience fewer injuries, compared to new runners who do not perform strength or coordination training prior to running.

The study will investigate the effect of a sequenced training program - beginning with strength training, followed by running-specific coordination exercises, and finally a gradual introduction to running - on strength, coordination and injury incidence in a group of novice runners. he investigators hypothesize that runners who perform strength and coordination training prior to beginning to run will 1) demonstrate greater lower extremity strength, 2) demonstrate alters coordination patterns and 3) experience fewer injuries, when compared to a control group of novice runners who perform no physical preparation prior to a gradual introduction to running. The possible long-term benefits of this study include reduced burden of running-related injuries, increased participation in the sport of running, improved cardiovascular and metabolic health characteristics, and reduced incidence of disease such as cardiovascular events and cancer.

Eligibility Criteria:
Inclusion Criteria:

* No previous participation in running races
* Run less than 10km total in past year
* Able to run continuously (ie at least 5mph) for 5 min (so that biomechanical analysis of running form can be conducted)
* Female participants may not be pregnant
* Participants will be screened using the PARQ+ form, and Parmed-X form completed by a physician if necessary
* Cleared for physical activity through screening
* English-speaking

Exclusion Criteria:

* Previous (at any time of life) training of 3 or months of consistently running 3 or more days per week
Use of Frequency Compression in Severe-profound Hearing Loss Adults

The purpose of this study is to investigate the functional benefits of frequency compression vs no frequency compression or fitted to hearing loss in severe-profound hearing impaired adults with high frequency hearing losses. Thus, assessing whether hearing aids for this patient population can be adapted to improve speech perception.

Frequency compression is a feature available on some digital hearing aids, which is aimed at increasing the audibility of high frequency sounds. It works by taking sounds above a fixed start frequency and compresses it into lower frequencies where residual hearing is better.

Eligibility Criteria:
Inclusion Criteria:

1. Participants must be over 18 years of age- This study is looking at the use of frequency compression \& its effects of speech perception in adults.
2. No ear surgery that would make it impossible to fit a hearing aid- To ensure limited confounding variables.
3. No history of ear surgery within the last 12 months- To ensure limited confounding variables.
4. No history of ear infection(s) within the last 6 months- To ensure no contraindications and limited confounding variables to testing.
5. No otoscopic abnormality making it impossible to fit a hearing aid- To ensure no contraindications to testing.
6. Bilateral severe-profound hearing impairment with air conduction thresholds \>71dBHL within the frequency range of 250Hz to 4 kHz- To analyse the effects of frequency compression on speech perception within this patient population.
7. Post lingual deafness, with good spoken English- To ensure reliability of speech testing.
8. Previous bilateral digital hearing aid experience (6+ months)- To ensure limited confounding variables.
9. Written consent required.

Exclusion Criteria:

1. Participants under the age of 18 years.
2. History of ear surgery making it impossible to fit a hearing aid.
3. History of ear surgery within the last 12 months.
SBIRT Implementation for Adolescents in Urban Federally Qualified Health Centers

The purpose of this study is to examine the implementation of two evidence-based intervention strategies of SBIRT (Generalist vs. Specialist) for adolescent alcohol, tobacco, other drug use, and HIV risk behaviors.

Guided by Proctor's conceptual model of implementation research, the proposed study is a multi-site, cluster randomized trial to compare two principal strategies of SBIRT delivery within adolescent medicine. In the Generalist Strategy, the primary care provider delivers brief intervention (BI) for substance misuse. In the Specialist Strategy, BIs are delivered by behavioral health counselors. The 7 study sites, primary care clinics operated by a large, urban Federally Qualified Health Center in Baltimore, will be randomly assigned to implement SBIRT for adolescents using either the Generalist or Specialist strategies. Staff at each site will be trained in the assigned implementation strategy, and quarterly booster trainings will be provided during the implementation period. Implementation outcomes, including: penetration, costs/cost-effectiveness, acceptability, timeliness, fidelity/adherence, and patient satisfaction will be assessed during the 18-month-long implementation period using a complementary combination of administrative service encounter data, provider and patient surveys, and qualitative interviews. At the end of the active implementation period, all training and technical support activities will cease for 12 months in order to measure relative sustainability. The study will also examine the effectiveness of integrating HIV risk screening within an SBIRT model.

Eligibility Criteria:
Inclusion Criteria:

* clinic staff

Exclusion Criteria:

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Transcranial Direct Current Stimulation for Impulsivity and Food-related Impulsivity in Obesity

In this study the investigators aim to assess whether transcranial direct current stimulation (tDCS; a safe non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate impulsivity in obese participants.

In this single-blind, sham controlled study, the investigators will assess whether transcranial direct current stimulation (tDCS; a safe non-invasive method for modulating the activity of specific brain regions) when applied over the orbitofrontal cortex (OFC) is able to modulate impulsivity in obese volunteers. The investigators hypothesize that tDCS applied to the OFC, in comparison to sham tDCS, will significantly reduce impulsivity and enhance decision making as measured by computerized neurocognitive tasks. For this study the investigators will enroll 30 obese individuals aged 18-65 years. Participants will be assessed with a battery of computerized tasks as well as self-reported questionnaires on eating, impulsivity, mood and anxiety. Assessments will be carried out before, during, and after a single 20-minute 2mA tDCS session.

Eligibility Criteria:
Inclusion Criteria:

* Men or Women aged 18 to 65
* have body mass index of 35 or above
* have had no recent change in medications in the 2 weeks prior participating in the study
* able to fast for 4 hours prior participating in the study

Exclusion Criteria:

* Active Substance use disorder
* Active Suicidal ideation
* Psychoactive Medication
* Past or current Gambling disorder
* Past or current Anorexia
* Past or current Bulimia Nervosa
* Past or current Psychosis
* Visual impairments preventing performance of the neuropsychological tasks
* Epilepsy
* Traumatic Brain Injury
* Stroke
* Neurological disorder affecting motor functions (Parkinsons, Huntington's, etc)
* Previous participation in tDCS research/treatment
Phonoaudiologic Therapy Adjunct to Treatment on Patients With Obstructive Sleep Apnea

Objective: to evaluate the effects of a speech therapy exercises program in the treatment of Obstructive Sleep Apna Syndrome (OSAS) patients based on the clinical and polysomnography (PSG) parameters.

Methods: 80 patients with OSAS will be evaluated: men, 25-65 years old, body mass index \< 35 kg/m2 and scores of Epworth Sleepiness Scale \> 9. Patients will be divided into four groups: I: 20 patients with OSAS underwent speech therapy; II: 20 patients with OSAS underwent placebo therapy of Speech Therapy; III: 20 patients starting treatment with CPAP underwent speech therapy; IV: 20 patients starting treatment with CPAP without speech therapy or placebo. The speech therapy include isometric and isotonic exercises to improve posture, mobility and muscle tone of the soft palate, pharyngeal constrictor muscles, tip and base of tongue, cheeks and lips. Placebo therapy includes relaxation exercises and stretching neck, without therapeutic purpose. Both therapies are applied for three months, three times a day, lasting 20 minutes each session. During the treatment, the subjects will be monitored in weekly meetings, for orientation and description of the exercises and return of the fulfilled exercises diary. The subjects will also be followed at the CPAP clinic in returns after one week, a month and at the end of the study. Conduct assessments before and after treatment and after twenty one days washout, including: assessing the upper airway, anthropometric investigation of the facial skeleton and speech of Orofacial, questionnaires (Epworth Sleepiness Scale, FOSQ, General Segment and use of CPAP, WHOQOL-BREF, snoring), Psychomotor Vigilance Test and PSG.


Eligibility Criteria:
Inclusion Criteria:

* Patients with a recent diagnosis of OSAS
* Body mass index (BMI) \< 35 kg/m2

Exclusion Criteria:

* Facial malformations
* Regular use of hypnotic medications
* Hypothyroidism
* Previous stroke
* Neuromuscular disease
* Heart failure
* Coronary disease
* Severe obstructive nasal disease
Relative Effectiveness of Schizophrenia Therapy Study

The purpose of this study is to validate that SULT4A1-1 status stratification improves responses to atypical antipsychotics in schizophrenia and to extend these findings into bipolar disorder.

The total economic burden for schizophrenia (SZ) in the U.S. is estimated to be more than $60 billion annually. A large contributor to the economic burden of this and other chronic mental disorders, including bipolar disorder (BPD), is the exacerbation of symptoms and disability due to lack of drug efficacy. For these disorders, clinicians typically choose a first line antipsychotic therapy without the support of a diagnostic tool; often, patients are switched to another drug after less than six months of treatment due to what is perceived by patients and clinicians as both insufficient efficacy and unacceptable side effects.

Originally, the sulfotransferase family 4A, member 1 (SULT4A1) gene was selected as a biomarker of interest in SZ based on results showing associations between the gene and disease severity. Later on, SULT4A1 gene status was also associated with better efficacy of atypical antipsychotic (e.g. Zyprexa® (olanzapine) and Risperdal® (risperidone)), with respect to both time to discontinuation and quantitative measures of clinical improvement.

In this prospectively designed, non-randomized retrospective study, we will recruit and genotype subjects with schizophrenia or bipolar disorder that were/are new to therapy for any of the four drugs under evaluation. By looking at retrospective and prospective longitudinal medical and pharmacy data stored within the integrated claims database, we will validate the association of the SULT4A1 gene to the efficacy of selected atypical antipsychotic therapies.

Eligibility Criteria:
Inclusion Criteria:

* Subjects ≥ 18 years of age
* Subjects with either a confirmed diagnosis of schizophrenia or bipolar disorder or subjects with self reported schizophrenia or bipolar disorder
* Subjects who were/are new to therapy for olanzapine, risperidone, quetiapine or ziprasidone
* Subjects who are willing and able to provide informed consent

Exclusion Criteria:

* Subjects initially prescribed less than the generally accepted minimally effective dose of the drugs under study
* Subjects with Major Depressive Disorder (MDD) or another psychotic disorder other than schizophrenia or bipolar disorder
* Subjects with catatonic schizophrenia
* Subjects with moderate to severe mental retardation
* Subjects that refuse to participate in the study
Team Based Equity Conscious Telemedicine Approach to Hypertension

The purpose of study is to understand the different factors (patient, societal, provider, clinic, health system) relevant in recruitment and participation of patients in Team Based Equity Conscious Telemedicine Approach to Improve Hypertension clinical trial.

Black patients suffer disproportionate hypertension (HTN) burden with worse control, resulting in HTN-related mortality rates twice those observed in non-Hispanic White patients. Contextually informed care approach is urgently needed in Black patients for HTN management. This study will evaluate multi-level barriers and facilitators for recruitment and participation of Black patients in a Team Based Equity Conscious Telemedicine Approach to Improve Hypertension (TET-HTN) clinical trial. This study will also evaluate the feasibility of TET-HTN intervention in a randomized comparison with usual clinic-based hypertension care approach.

Eligibility Criteria:
Inclusion Criteria:

* African American or Black
* Patients with last clinic systolic Blood Pressure \>140 mmHg or diastolic Blood Pressure \>90 mmHg or both

Exclusion Criteria:

* Unable to read or speak English
* diminished ability to measure home BP (dementia, or psychosis)
* acute health changes in past 3 months increasing chance of BP instability (hospitalization);
* terminal illness.
Cognitive Functional Therapy Versus Exercises for Chronic Shoulder Pain

The objective of this clinical trial is to determine whether cognitive functional therapy is superior to therapeutic exercises for the treatment of chronic shoulder pain. The main questions it aims to answer are:

Is cognitive functional therapy superior to therapeutic exercises for pain and disability in individuals with chronic shoulder pain? Is cognitive functional therapy superior to therapeutic exercises for functionality and psychosocial factors?

Participants will:

Receive 4 to 8 sessions of cognitive functional therapy once a week for four to eight weeks.

Follow a therapeutic exercise protocol for eight weeks with a frequency of twice per week.

This will be a randomized controlled trial, single-blind, with two parallel groups. Ninety-two individuals with chronic shoulder pain will be randomly assigned to one of two groups: Cognitive functional therapy (CFT) or therapeutic exercises. The interventions will last between four and eight weeks, with the CFT group receiving therapy once a week and the therapeutic exercise group receiving sessions twice a week for eight weeks. The primary outcomes will be pain intensity and disability, while the secondary outcomes will include specific function, kinesiophobia, self-efficacy, sleep quality, treatment expectations, perception of change, and treatment satisfaction.

Eligibility Criteria:
Inclusion Criteria:

Individuals of both sexes, aged between 18 and 65 years, will be included if they have had shoulder pain for at least 3 months and report a pain intensity of at least 3 points on the Numeric Pain Rating Scale (NPRS) at rest or during arm movement. Additionally, they must have a minimum score of 20 points on the Shoulder Pain and Disability Index (SPADI).

Exclusion Criteria:

Individuals will not be included if they have adhesive capsulitis, defined as a loss of more than 50% of passive shoulder range of motion in external rotation; previous shoulder surgery; a history of shoulder fracture; systemic musculoskeletal diseases (e.g., rheumatoid arthritis, fibromyalgia); shoulder pain reproduced by active or passive cervical spine movement; signs of glenohumeral instability identified by a positive sulcus test or a positive apprehension test indicating laxity in the glenohumeral joint; self-reported systemic disease; a positive drop arm test; pregnancy; active cancer treatment; neurological diseases; cognitive impairments; corticosteroid injection within three months prior to the intervention; or physical therapy in the three months preceding the study.

Participants will be discontinued from the study if they experience fractures, surgeries, musculoskeletal or neural injuries that prevent access to treatment, or receive corticosteroid injections during the treatment or follow-up period.
Stress Physiology and Intervention Feasibility Among First Responder Parents

The specific aims of this study are to: 1. Demonstrate the usability and acceptability of a smart watch in parents to remotely monitor stress responses or symptoms in individuals participating in prevention or treatment interventions. 2. Examine the association between heart rate variability (HRV) data and momentary self-reports of stress by parents. 3. Conduct a feasibility study to establish the effectiveness of wearables and apps to improve emotion regulation in the short term (minutes, hours) and concomitant social, emotional, and behavioral outcomes over the longer-term (weeks).


Eligibility Criteria:
Inclusion Criteria:

* Have at least one child between the ages of 4 and 13 that resides with them in states of Kentucky or Tennessee
* Be able to wear a wrist-based wearable device
* Be able to read, write, and speak in English
* Not be allergic to polycarbonate or silicone
* Have a smart phone
* Work full time (at least 30 hours/week) as a first responder OR be a co-parent (defined as living in the same home and shares parenting responsibilities) of an eligible first responder

Exclusion Criteria:

* Do not have a child in the specified age range
* Have a child in the specified age range but who does not reside with them
* Are first responders who average less than 30 hours/week
* Are not a cohabitating parent
* Are a co-parent of eligible first responders who is not participating in the study
Exercise and Prevention of Syncope: EXPOSE

The purpose of this study is to determine whether eight weeks of exercise performed at an intensity of approximately 65% VO2max will improve symptoms associated with fainting (vasovagal syncope).

Background: Vasovagal syncope affects 20-30% of the population, and for those who faint recurrently it causes a significant reduction in the quality of life. Although significant progress has been made in the past 15 years in our understanding of its diagnosis and prognosis, our therapeutic attempts often end in failure. Many patients who have been diagnosed with vasovagal syncope have a reduced orthostatic tolerance. Improved orthostatic tolerance has been achieved through exercise in a number of studies on healthy individuals. However, its efficacy as a means of treatment for those with vasovagal syncope has not been thoroughly explored.

Comparison: Subjects will be randomized to one of two groups: an exercise group or control. The exercise group will be asked to train at a target of approximately 65% of their maximum exercise capacity (VO2max) for 8 weeks/3 times per week. The control group will be asked to perform a series of neck rotation exercises. Orthostatic tolerance will be examined in both groups pre and post intervention.

Eligibility Criteria:
Inclusion Criteria: a diagnosis of vasovagal syncope as the cause of loss of consciousness, \>1 lifetime syncope spell preceding enrolment, \>-3 points on the S3 score for structurally normal hearts, \>18 yrs of age with informed consent -

Exclusion Criteria: subjects with a negative Physical Activity Readiness Questionnaire (PARQ), those who are unable to provide informed consent, those with a VO2max \>55ml/kg/min, those who exercise more than 30 minutes per day, 3 times per week, other causes of syncope, individuals with valvular, coronary, myocardial, or conductive abnormality, significant arrhythmia, hypertrophic cardiomyopathy, permanent pacemaker, seizure disorder, heart failure, major chronic cardiovascular disease, or renal dysfunction.

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Quality of Life and Sexuality of Patients Over 65 Years Undergoing Adjuvant Treatment for Breast Cancer

The purpose of this study is to assess the quality of life and sexuality during adjuvant chemotherapy in over 65 years old patients with breast cancer

Evaluation of quality of life and sexual health will be assessed by the mean of validated self questionnaires after surgery for breast cancer, before and after adjuvant chemotherapy and one year after initial surgery

Eligibility Criteria:
Inclusion Criteria:

* Women over 65 years of age
* treatment by adjuvant therapy for breast cancer
* pTxNxM0
* sexually active at least three months before inclusion
* in couple or not

Exclusion Criteria:

* Inflammatory breast cancer
* Not sexually active before breast cancer diagnosis
* Opposition to fill sel questionnaire and collection of the data
Early Screen for Discharge Planning in Community Hospitals

The purpose of this study is to determine the predictive performance of the Early Screen for Discharge Planning (ESDP) tool in a regional community hospital. The central hypothesis is that the ESDP differentiates between patients in a regional community hospital who would benefit from those who would not benefit from early discharge-planning intervention as measured by problems and unmet continuing care needs, quality of life, length of stay, and referrals to post-acute services.

Patients who are hospitalized for medical or surgical reasons who consent to the study will be screened within 24 hours of hospital admission using the Early Screen for Discharge Planning (ESDP). The ESDP is a four-item screening tool used to determine on admission which patients are likely to have complex discharge plans and could benefit from early engagement of discharge planning personnel. The ESDP yields a total score, and those with a score of 10 or greater are considered to have a "high score" and likely to have a complex discharge plan. Those with a score of 9 or below have a "low score". The ESDP screen has been proven to be valid in large academic medical centers. This study will determine if the screen performs with the same validity in a small community hospital.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Able to read and speak English
* Returning home in the community after discharge

Exclusion Criteria:

* Discharged to facility care
* Pregnant females
A Cross-Sectional Natural History Study to Evaluate Sweat Volume and Other Phenotypic and Genetic Characteristics in Patients Affected by XLHED

The proposed natural history study will enroll male patients with a diagnosis of XLHED, female carriers of XLHED and healthy volunteers. The study protocol will include collection of XLHED questionnaires and clinical outcomes using minimally invasive technologies. Data will be collected both retrospectively and prospectively.

Clinical outcome assessments will be performed at the NFED Family Conference on July 11-12, 2019. Study participants will be able to complete XLHED questionnaires electronically ahead of the conference.


Eligibility Criteria:
Inclusion Criteria:

* Informed Consent
* Males with XLHED, female carriers of XLHED and healthy volunteers

Exclusion Criteria:

* Treatment with an investigational study drug for XLHED
* Any major medical problems that would prevent her/him from participating in this study
* Known hypersensitivity to pilocarpine or pilocarpine-like muscarinic agonists (Examples: Urecholine, Salagen, Pilocar, and Provocholine)
* Pacemaker
Community-Acquired Pneumonia (CAP) Surveillance

Prospective, non-interventional, multi-center study. 7 investigative centers will involved in China. Around 560 CAP outpatients or inpatients will be screened until 56 M. pneumoniae isolates collected.


Eligibility Criteria:
Inclusion Criteria:

* Chinese adult (male or female) ≥18 years old
* Outpatients or inpatients who suffer from CAP

Exclusion Criteria:

-