cyrilzakka/clinical-trials huggingface dataset:
Determining the Effect of Breathing Exercise Applied to Children Aged 6-12 Before Enema on Anxiety, Fear and Pain

In this study, it was aimed to determine the effect of breathing exercise applied before the enema procedure, which causes fear, pain and anxiety in children aged 6-12 years who applied to the pediatric emergency service, on fear, pain and anxiety in children. This research is in pretest-posttest, parallel group, randomized controlled experimental design.

The universe of the research consists of children aged 6-12 years who applied to the pediatric emergency department of Iğdır State Hospital (Turkey) between May 2022 and June 2022.

In this study, it was aimed to determine the effect of breathing exercise applied before the enema procedure, which causes fear, pain and anxiety in children aged 6-12 years who applied to the pediatric emergency service, on fear, pain and anxiety in children. This research is in pretest-posttest, parallel group, randomized controlled experimental design.

The universe of the research consists of children aged 6-12 years who applied to the pediatric emergency department of Iğdır State Hospital (Turkey) between May 2022 and June 2022.

In the study, the pre-test scores of the pain, fear and anxiety levels of the children were compared and it was found that the pain, fear and anxiety levels of the intervention and control groups were moderate, and there was no difference between the groups. This result is important in terms of evaluating the effectiveness of the initiative.

In the study, a significant difference was found between the pain, fear and anxiety levels of the intervention and control groups after breathing exercise. Accordingly, the pain, fear and anxiety levels of the intervention group were significantly lower than the control group.

Eligibility Criteria:
Inclusion Criteria:

* Being between 6-12 years of age
* Administering an enema because of constipation or distension
* There should be no obstacle to the enema procedure
* Child and parent agree to participate in the study

Exclusion Criteria:

* Having a mental disability
* Having any problems with hearing, vision, hearing
* Taking analgesics within the last 6 hours
* Having an additional illness that may cause pain

Removal criteria were as follows:

* Developing complications during the enema procedure (intestinal perforation, bleeding, etc.)
Open-Label Duloxetine Monotherapy in the Treatment of Posttraumatic Stress Disorder

The purpose of this study is to determine whether Duloxetine (Cymbalta®) is an effective treatment in reducing the symptoms of Posttraumatic Stress Disorder (PTSD).

Duloxetine has established efficacy for treatment of major depression, generalized anxiety disorder and diabetic peripheral neuropathic pain. Chronic PTSD is often treated with antidepressants, in fact there are only two FDA-approved treatments for PTSD. Yet many chronic PTSD patients, especially male combat veterans, have a limited response to antidepressant treatment (Baker et al, 1995; Cañive et al, 1998; Hertzsberg et al 2000) and new pharmacotherapies should be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Male or female patients ages 18 or older of any ethnic background meeting DSM-IV criteria for PTSD
* Score of at least 60 on the CAPS-SX at baseline
* Competent to give informed consent
* If female, patient should be using a medically approved contraceptive, or not otherwise be of childbearing potential
* Patients who have not taken medications or herbal remedies for a psychiatric indication within one week prior to the baseline visit (treatment phase); two weeks prior in the case of fluoxetine or in the case of an MAOI
* Other medications, if any, must have been kept stable for at least one month prior to the baseline visit

Exclusion Criteria:

* Known hypersensitivity to duloxetine or any of the inactive ingredients
* Females who are pregnant or breastfeeding
* Use of antipsychotics, antidepressants, or benzodiazepines (except for short-term use during study as specified in Concomitant Medications section) within one week prior to the baseline visit and throughout the study period
* Use of fluoxetine or an MAOI within two weeks
* Concomitant use of narrow therapeutic index medications or medications that are likely to have a clinically significant drug interaction with duloxetine
* Medical conditions that may prevent safe administration of duloxetine including end stage renal disease, clinically significant renal impairment (CrCl \<30 mL/min), hepatic insufficiency, cardiac disease, or pulmonary disease
* Patients with uncontrolled narrow-angle glaucoma
* Alcohol or drug abuse or dependence within three months of study entry as defined by DSM-IV criteria
* Alcohol use may not exceed 12 drinks per week or 5 drinks per drinking episode during the course of the study.
* A current or past history of bipolar disorder, schizophrenia, schizoaffective disorder or other psychotic disorder
* Suicidal or homicidal ideation or other clinically significant dangerous behavior
* Currently seeking compensation or increase in compensation for the effects of the trauma
* Initiation or change in psychotherapy within 3 months of study entry
Mechanistic Studies on Video-guided Acupuncture Imagery Treatment of Pain

The aim of this proposal is to investigate brain response and connectivity changes evoked by video-guided acupuncture imagery treatment (VGAIT) and verum and sham acupuncture in healthy and patient populations to elucidate the underlying brain mechanisms of mind-body interaction, imagery, and acupuncture.


Eligibility Criteria:
Inclusion Criteria:

* Right handed healthy male and female adults aged 18-60
* No contraindications to fMRI scanning

Exclusion Criteria:

* Current or past history of major medical, neurological, or psychiatric illness
* Any pain disorder
* Pregnancy
* Non-fluent speaker of English
Comparison of the Clinical and Microbiological Effects of CHX and HOCl Containing Mouthwashes

The primary objective of the study is to compare the antiplaque and anti-inflammatory effects of HOCl mouth rinse with those of CHX mouth rinse. The secondary objective is to evaluate and compare the antimicrobial activities of HOCl mouth rinse and CHX mouth rinse on dental biofilm.

The primary objective of the current clinical study is to compare the antiplaque and anti-inflammatory efficacy of HOCl mouth rinse with that of CHX mouth rinse. The secondary objective is to compare the antimicrobial activities of these two mouth rinses on dental biofilm. This single-center, triple-blind, randomized controlled crossover study was completed with 26 participants. In the study, the same participants used both HOCl (0.02%) and CHX (0.2%) mouth rinses over a 4-day re-plaque formation model. Following each mouth rinse usage, supragingival dental plaque biofilm samples were collected, and clinical parameters including the Modified Plaque Index, Bleeding on Probing Index, and Modified Stain Index were recorded. Additionally, participants were asked to evaluate the mouth rinses they used via a questionnaire. In conclusion, HOCl mouth rinse has demonstrated antiplaque efficacy comparable to that of CHX mouth rinse. When evaluating total bacterial counts, both mouth rinses exhibited similar antimicrobial effectiveness. Within the limitations of this study, HOCl may be considered a promising antimicrobial agent for dental plaque control.

Eligibility Criteria:
Inclusion Criteria:

* Being systematically healthy
* Having at least 22 natural teeth (236)
* Not smoking
* Participants must not drink alcohol and must work during their term

Exclusion Criteria:

* Having periodontitis and gingivitis
* Being breastfeeding or pregnant
* Using medication that may affect periodontal status
* Having used antibiotics in the last month
* Having used any mouthwash in the last month
* Using fixed, removable dentures or orthodontic appliances
Effectiveness of Gelatamp in Wound Healing After Teeth Extraction: A Randomized Clinical Trial

This study compares the effectiveness of Gelatamp for intraoral wound closure after extraction of mandibular teeth.

In the interventional group, after extraction of mandibular teeth, the extraction socket will be augmented with Gelatamp. Then a gauze pack will be placed over it.

In the control group, after extraction of mandibular teeth, a gauze pack will be placed over the socket.

Eligibility Criteria:
Inclusion Criteria:

* Patients requiring extraction of mandibular teeth
* Healthy patients (ASA I) or patients with mild systemic disease but no functional limitations (ASA II)
* Patients not allergic to the drugs or anesthetics used in the study.

Exclusion Criteria:

* Patients taking medications that influences wound healing
* smokers
* Uncooperative patients
* Patients requiring extraction of grade II or III mobile teeth
* Patients requiring surgical extraction of teeth.
BiPAP in Pediatric Moderate to Severe Asthma Randomized Control Trial

The goal of this clinical trial is to study if starting bi-level positive airway pressure (BiPAP), a mask that gives pressure to the lungs, works well for children in the emergency department with moderate to severe asthma attacks. The main questions it aims to answer are:

1. Whether initiation of BiPAP at the same time as continuous beta-agonist therapy (e.g., nebulized albuterol) will decrease how long children with moderate to severe asthma attacks need to receive continuous beta-agonist therapy.
2. Whether early BiPAP changes how the lungs function in children with asthma attacks.
3. Whether children receiving early BiPAP experience more issues or side effects than those children who do not.

All children will receive the usual treatment for asthma attacks; if they are still experiencing moderate to severe symptoms after the initial treatment, they will be asked to participate in the study. Participants will then wear a mask while they are receiving the continuous beta-agonist therapy. Some patients will receive BiPAP where pressure is given to the lungs and others will have a sham BiPAP mask where no pressure is given to the lungs. Study participants will wear the mask for 4 hours or until their treatment team feels they are ready to come off of the continuous beta-agonist therapy. Participants will receive more medications and decisions on going home or being admitted to the hospital will be decided as usual by their treatment team.

Researchers will compare BiPAP versus Control (Sham BiPAP) groups to see if there is a difference in how long continuous beta-agonist therapy is needed, how the lungs are functioning, and number or type of side effects.


Eligibility Criteria:
Inclusion Criteria:

* 5 to 17 years of age (inclusive) presenting to the ED with an asthma exacerbation
* Prior diagnosis of asthma by a physician who prescribed asthma medications (beta-agonist and/or inhaled or oral steroids)
* PRAM score of 4 or greater after administration of first-line therapy (albuterol/ipratropium back to backs, corticosteroids, +/- oxygen) and need for continuous beta-agonist therapy after first-line therapy

Exclusion Criteria:

* Prior participation in the study
* Hypercapnic (PaCO2 \> 60 mmHg) respiratory failure or need for invasive mechanical ventilation as determined by the treating physician
* Hypoxemic respiratory failure (SaO2 \< 90% with fraction of inspired oxygen inspired oxygen fraction (FiO2) \> 0.35)
* Presence of a tracheostomy or baseline noninvasive ventilation requirement
* Non-asthma causes of wheezing: foreign body, tracheomalacia, vocal cord dysfunction, pulmonary edema, uncorrected congenital heart disease, cystic fibrosis, anaphylaxis
* Absolute or relative contraindication to BiPAP: facial trauma, uncontrollable vomiting, hypotension for age, Glasgow Coma Score of 8 or less, drowsiness or confusion, known or clinical suspicion for pneumothorax, pneumomediastinum, or subcutaneous emphysema, pregnancy
PRone positioN in Patients With spontanEous ventiLation and Acute Hypoxemic respIratory FailurE

The proposed randomized controlled trial aims at comparing the application of the prone position in spontaneously breathing patients with acute hypoxemic respiratory failure from any cause versus standard treatment on the rate of invasive mechanical ventilation or all-cause of mortality. The secondary endpoints will include time to tracheal intubation and effects of awake proning on the oxygenation parameters, dyspnea sensation, complications, and tolerance. Other endpoints are ventilation free-days at 28 days, duration of invasive ventilation, length of ICU and hospital stay, ICU and hospital mortality, and 28, 60, and 90-day mortality.

The investigators intend to recruit acute hypoxemic respiratory failure patients with a respiratory rate of more than 25 breaths per minute, SpO2 \< 94% and FiO2 of at least 40% or more by either Venturi facemask, HFNC, or NIV/CPAP and, absence of decompensated respiratory acidosis during two years. Currently, the investigators expect about 35 centers to participate in the trial.

Demographic data and clinical characteristics on screened patients, regardless of enrolment criteria match, will be recorded (registry). The investigators will randomize 650 patients admitted to the participating centers' intensive care units and expect each participating center to randomize at least 25 patients who meet all inclusion criteria.

Eligibility Criteria:
Inclusion criteria

* \>18 years
* Acute respiratory failure from any cause
* Admitted to a participating ICU
* Written informed consent

Exclusion criteria

* Presence of any contraindication to prone position (APPENDIX i)
* The patient meets the criteria for intubation (see item 7.2.3)
* Participating in other interventional studies with the same primary outcome
* Receiving comfort care only
* Pregnancy
Use of Adapted Controllers for Active Video Gaming in People With Physical Disabilities

The purpose of this study is to compare the effectiveness of off-the-shelf (OTS) and adapted game controllers on quality of game play, enjoyment, and energy expenditure during active video gaming in persons with mobility impairments. The controllers to be evaluated include off-the-shelf and adapted gaming mats and off-the-shelf and adapted Wii Fit balance boards.

Previous studies have shown that individuals with disabilities have lower levels of physical activity and fitness and higher levels of obesity compared to their non-disabled peers. Research has also shown that engaging this population in physical activity can be extremely challenging due to physical impairments associated with their disability, as well as fewer opportunities to participate.

Active video games (AVG), also known as exergames, are a category of video games that require much more body motion for successful play than the traditional pushbutton or joystick actions. The recent introduction of motion controlled AVGs allow a much greater variety of physical activity to be part of play. These games hold promise for promoting higher levels of energy expenditure, weight management and fitness. However, many current AVGs are inaccessible or offer limited play options for individuals who are unable to stand, have balance issues, poor motor control, or cannot use their lower body to perform game activities. Making AVGs accessible to people with disabilities offers an innovative approach to overcoming various barriers to participation in beneficial physical activity.

A recent publication by Dr. Rimmer in the Physical Medicine and Rehabilitation journal examining the use of AVGs as a means to increase energy expenditure in non-ambulatory young adults with disabilities suggested that clinically significant increases in energy expenditure could be achieved with AVGs.

Eligibility Criteria:
Inclusion Criteria:

* Potential participants must have a confirmed diagnosis of lower extremity mobility disability (e.g., spina bifida, cerebral palsy, muscular dystrophy,1 year post spinal cord injury, multiple sclerosis, stroke, or limb loss) with partial or full use of upper extremities and use of an assistive device (manual wheelchair, walker, crutches, or canes) for balance and/or mobility or should have gait deviation.
* Participants must be between the ages of 10 and 60 yrs, and not weigh more than 350 pounds.

Exclusion Criteria:

* Unstable cardiovascular conditions as identified by their physician.
* Weight over 350 pounds
* Visual impairment that interferes with playing video games
Shwachman Diamond Syndrome Registry and Study

Shwachman-Diamond syndrome (SDS) is a genetic condition characterized by bone marrow failure, medical co-morbidities, and leukemia predisposition. SDS-Like patients share clinical features with SDS but lack mutations in known SDS genes. Since SDS/SDS-Like syndromes are rare diseases, data are sparse regarding the clinical features, natural history, clinical outcomes with current management, and treatment. For this reason, the SDS Registry was formed to collect clinical data from medical records and to bank biological samples with the goal of understanding SDS/SDS-Like diseases to develop better treatments and improve the health of patients with these conditions.

The Shwachman-Diamond Syndrome Registry (SDSR) is dedicated to accelerating research and treatment for SDS to improve survival and quality of life for all patients with the disease. The SDSR is run jointly by Boston Children's Hospital and Cincinnati Children's Hospital Medical Center.

Objective and Aims:

The long term goals of the Registry are to improve diagnosis, inform medical management, and to develop better treatments for SDS and SDS-Like disorders.

To achieve these objectives, the Registry has the following specific aims:

* Characterize the natural history, medical complications, and treatment outcomes for patients with SDS and SDS-Like disorders.
* Investigate the molecular and genetic pathogenesis of SDS/SDS-Like conditions and their complications such as marrow failure and clonal evolution.
* Identify new genes causing SDS/SDS-Like conditions.
* Provide education on the diagnosis, medical management and treatment of SDS for patients, families and the medical/scientific community.

Methods: The SDSR collects information from medical records and biological samples. Samples for the SDSR are collected when they are obtained for clinical care so that no extra visits or procedures are needed. These samples may include blood, bone marrow, skin cells, saliva, or discards from other clinical procedures. Family members may also contribute blood samples. All information obtained by the SDSR is housed on a secure, HIPAA-compliant database. No personal information is shared outside of the study team.

Eligibility Criteria:
Inclusion Criteria: Shwachman Diamond syndrome, Shwachman-Diamond Syndrome-Like conditions, or a genetically undefined condition that shares clinical features with Shwachman Diamond Syndrome.

* Biallelic mutations in SBDS, or pathogenic mutations in DNAJC21, EFL1, or SRP54 OR
* Shwachman-Diamond Syndrome defined clinically OR
* Clinically suspected Shwachman-Diamond Syndrome OR
* Phenotypic features suggestive of SDS OR
* Parents, siblings, and other blood relatives of any age, living and deceased, of patients with SDS or SDS-Like conditions are eligible for this study

Exclusion Criteria:

• Patients with other diagnosed causes of bone marrow failure, exocrine pancreatic insufficiency and cancer predisposition will be excluded.
Effects of Backward Gait Training in Chronic Stroke Patients

Loss of motor control after stroke, muscle weakness, abnormal movement patterns, spasticity, range of motion limitations and sensory dysfunction, resulting in a decrease in the load transferred to the affected limb, changes in gait pattern and balance skills. Post-stroke muscle weakness has been shown to occur not only in the lower and upper extremity muscles but also in the respiratory muscles. It was found that the plantar pressure distribution in the affected side feet was decreased in individuals with stroke and this situation negatively affected the walking function. A systematic review of treadmill training revealed that treadmill training significantly increased walking speed and walking distance. Learning to walk backwards is also recommended to improve the movement components required for walking forward. As a result of the investigations, although there are studies about the effects of back-walking training on walking and balance function in chronic stroke patients, there is no study investigating the effects on plantar pressure distribution and respiratory parameters. Therefore, this study, which planned to investigate the effects of treadmill retching training on balance, plantar pressure distribution and respiratory parameters in chronic stroke patients, will contribute to the literature.


Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the study
* More than 6 months have passed since the onset of stroke
* First time stroke diagnosis
* Being between the ages of 40-65
* Spasticity severity in lower extremity less than 3 according to Modified Ashworth Scale,
* Being medically stable
* Ability to walk 10 meters and above without assistance

Exclusion Criteria:

* Presence of other neurological or orthopedic diseases that affect standing and walking involving the lower limbs
* Uncontrollable Hypertension
* Having been diagnosed with any pulmonary disease
* Severe cardiac conditions
* Uncontrollable DM
* Lack of cooperation
Preventing Dyspnea During Speech in Older Speakers

Due to various comorbidities affecting the respiratory system, older speakers are at risk of experiencing breathing discomfort (dyspnea) during high-demand vocal activities such as singing, loud speaking, and speaking while exercising. Dyspnea during speech can promote avoidance of certain situations involving voice production, thus leading to vocal deconditioning and decreased quality of life. The goal of this pilot study is to test the feasibility and acceptability of a 4-week remote group intervention targeting phonatory dyspnea, and to gather preliminary efficacy data.

Participants will receive an intervention including a 2-week socialization phase (control condition) and a 4-week speech breathing intervention phase (experimental condition). Both phases will be delivered remotely and in a group setting (10 participants per group).


Eligibility Criteria:
Inclusion Criteria:

* sign the informed consent form
* report dyspnea in at least one of the items of the University of Cincinnati Dyspnea Questionnaire referring to speech
* be available during the dates of the scheduled group interventions
* be aged 50 years or older

Exclusion Criteria:

* do not have access to a computer and internet connection
* present with a known voice pathology (other than age-related vocal fold atrophy) and/or are receiving speech therapy at the time of the study
* have a known neurodegenerative disease affecting speech/voice
* are a current smoker
* are receiving pulmonary rehabilitation at the time of the study or are starting a new medication regimen for a respiratory disease at the time of study onset;
* have a hearing loss that is not adequately managed, as judged by the Principal Investigator (PI)
* have professional vocal training \[amateur choir singers will not be excluded\]
* cannot provide informed consent or easily follow instructions
* have any other condition that precludes them from participating in the behavioral interventions, as judged by the PI.