cyrilzakka/clinical-trials huggingface dataset:
Non-immersive Virtual Reality for Pediatric Pain Management

This is a multicenter, randomized, clinical trial comparing treatment as usual to distraction with video projection or virtual reality in the management of pediatric (3-6 years) pain associated with venipuncture, intramuscular injection, and vaccination.

Background: Recent studies have shown that the use of virtual reality (VR) may be useful to provide distraction that attenuates pain in minimally invasive procedures in preschool children.

Aim: To assess the effectiveness of non-immersive virtual reality as a pain-distraction measure in children between the ages of 3 to 5 years undergoing painful injection procedures in an outpatient setting.

Method: This clinical trial will recruit patients under 6 years of age treated at participating medical centers in whom a painful procedure like vaccination, venipuncture or administration of intramuscular medication will be performed. The experimental group will consist of two subgroups which, in addition to treatment as usual, will be distracted using virtual reality content delivered through goggles. The control group will receive treatment as usual. The LLANTO pain scale will be used to measure different characteristics of pain. This scale has been validated in Colombia, and will be filled by two health professionals (one of which will perform the painful procedure.) and the parents.

Expected results: To show that virtual reality or projector distraction are effective distraction tools in pain management for children subjected to painful procedures of venipuncture, intramuscular medication administration, and vaccination.

Eligibility Criteria:
Inclusion Criteria:

* Patients subjected to procedures of venipuncture, intramuscular injections, or vaccination at participating medical centers.

Exclusion Criteria:

* Fever (Axillary temperature greater than 38°C).
* Systemic Inflammatory Response Syndrome or Sepsis.
* Pulmonary disease.
* Neurological deficit of any kind.
* Susspected or confirmed metabolic disease.
* Undernutrition or obesity as defined by deviations from the mean of local values.
Intradialytic Progressive Resistance Training for Maintenance Haemodialysis Patients

The purpose of this study is to investigate the effects of a 12 week progressive resistance training during haemodialysis on muscle quantity and physical functioning in chronic kidney disease patients receiving maintenance haemodialysis.

It is hypothesised, based on previous literature involving similar resistance training protocols in other catabolic conditions, that the resistance training will result in a significant increase in muscle quantity as well a physical function.

Muscle wasting is common in patients with chronic kidney disease and has been associated with decreased ability to complete activities of daily living, increased hospitalisation and therefore and decreased quality of life.

In other catabolic conditions, such as cancer or rheumatoid arthritis, exercise is an established treatment to reverse muscle wasting. It is uncertain whether exercise has this effect in the chronic kidney disease population due to an altered hormone system that may prevent the anabolic effects of exercise from occurring. However, progressive resistance training, which is exercise that is most effective at eliciting an anabolic response has not been effectively carried out with haemodialysis patients.

Therefore, this study aims to investigate whether or not a twelve week intradialytic progressive resistance training programme will have an effect on muscle quantity, physical function and quality of life in patients receiving maintenance haemodialysis.

Eligibility Criteria:
Inclusion Criteria:

* Chronic kidney diseases stage five requiring maintenance hemodialysis.

Exclusion Criteria:

* Patients who have been receiving dialysis for less than 3 months;
* Are under the age of 18years;
* Have medical contradictions to participate in the exercise programs;
* Any uncontrolled medical condition which does not allow participation in exercise;
* Have known neuro-muscular disorders;
* Have any other uncontrolled medical condition, including pregnancy;
* Are not independently ambulant for 50 m;
* Have received anabolic intervention, or had catabolic conditions within the last 3 months;
* Have a cardiac pacemaker or other unsuitable implanted device for magnetic resonance;
* Are vulnerable to heat stress;
* Or are unable to give consent.
Short-pulse Subthreshold vs Infrared Micropulse for Diabetic Macular Edema

When applied according to manufacturer recommendations, short-pulse system may yield more temporary reduction in edema while infrared micropulse system may yield slightly better functional outcomes.

Purpose: To assess both anatomic and functional outcomes between short-pulse continuous wavelength and infrared micropulse lasers in the treatment of DME.

Materials and Methods: A prospective interventional study from tertiary care eye hospital - King Khaled Eye Specialist Hospital (Riyadh, Saudi Arabia). Patients with center-involving diabetic macular edema were treated with subthreshold laser therapy. Patients in the micropulse group were treated with the 810-nm diode micropulse scanning laser TxCell™ (IRIDEX Corporation, Mountain View, CA, USA). Laser was applied according to manufacturer recommendations for MicroPulseTM in a confluent mode (low intensity/high density) to the entire area of the macular edema. Patients in the short-pulse group were treated with grid pattern laser with 20ms pulse PASCAL laser 532nm (TopCon Medical Laser Systems, Tokyo, Japan) with EndPoint algorithm, which was either 30% or 50% of testing burn. Main outcome measures included best-corrected visual acuity (BCVA) and foveal thickness at baseline and the last follow-up visit.

Eligibility Criteria:
Inclusion Criteria:

* center-involving clinically significant macular edema due to diabetic retinopathy (\>300 microns)
* clear ocular media
* ETDRS visual acuity \>29 letters (Snellen equivalent of 20/150) or better
* treatment naïve eyes or previously treated with antiangiogenic intravitreal agent(s) more than 6 months ago to allow for long wash-out period

Exclusion Criteria:

* non-center involving diabetic macular edema
* previous retinal laser or surgery
* intravitreal steroid use
* any condition that may be associated with a risk of macular edema such as age-related macular degeneration, retinal vein occlusion, vitreomacular traction, epiretinal membrane and others.
Focused Ultrasound for the Treatment of Neuropathic Pain

A possible treatment approach for neuropathic pain would employ a process designed to promote healthier function of the ventral posteromedial (VPM) and ventral posterolateral (VPL) thalamic nuclei. This study is designed to employ focused ultrasound technology to target the VPM and VPL thalamus among participants with ongoing neuropathic pain syndromes to evaluate for tolerability and early efficacy.

The present open-label study is being undertaken to evaluate focused transcranial ultrasound therapy as an intervention for patients with neuropathic pain. The subjects in this research study will be recruited through medical practice. Participants who are enrolled will undergo 8 consecutive weekly ultrasound sessions. Targeting for treatment will be based on patient MRI scans using stereotaxic techniques.

Eligibility Criteria:
Inclusion Criteria:

* History of neuropathic pain (onset, location, intensity, duration, quality, aggravating factors)
* Confirmation of nervous system injury through imaging or negative or positive sensory signs confined to the corresponding bodily area
* Failure from at least 3 pharmacological treatments (e.g., antidepressants, anticonvulsants, opioids)
* At least 18 years of age

Exclusion Criteria:

* Subjects unable to give informed consent
* Subjects who would not be able to lay down without excessive movement in a calm environment
* Pregnancy, women who may become pregnant or are breastfeeding
* Subjects with scalp rash or open wounds on the scalp (for example from treatment of squamous cell cancer)
Airway Pressure Release Ventilation (APRV) Versus AC/VC Conventional Ventilation

APRV mode of ventilation will result in an improved partial pressure of arterial oxygenation/ fraction of inspired oxygen (P/F ratio) on day 3 of mechanical ventilation. Sub hypotheses: APRV will be associated with a reduced amount of sedation used during the ICU stay in patients with respiratory failure. APRV will be associated with a reduction in the amount of vasoactive medication used for blood pressure support in patients with respiratory failure.

This prospective un-blinded randomized trial will follow patients with respiratory failure and ALI/ARDS who require invasive mechanical ventilation in select ICUs. Patients will be allocated to respiratory support with either APRV mode or volume control (AC) mode of mechanical ventilation. Qualifying patients will be randomized by permuted block randomization within 24 hours of admission to the ICU. Identical ventilation and oxygenation thresholds will be utilized to guide titration of each ventilator protocol. Patients will remain on the assigned mode of ventilation until they are extubated and discharged from the ICU.

Procedures for treatment evaluation include daily monitoring of the Ventilator protocol in each arm. Clinical coordinator and study respiratory therapist will perform 2 daily checks of the study patients to determine compliance with the protocol and if patient meets weaning criteria. The previously published ARDS Network continuous positive airway pressure (CPAP) weaning protocol will be used for all patients enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Hypoxemic respiratory failure requiring mechanical ventilation for \>24 hours.

Exclusion Criteria:

* Age under 18
* Severe chronic obstructive lung disease
* Patients in whom the only indication for mechanical ventilation is airway protection from poor neurological status.
The Sakakibara Health Integrative Profile of Atherosclerotic-Carcinogenesis Hypothesis (SHIP-AC)

As previously reported (IJC Heart \& Vasculature 2017; 17: 11.), our epidemiological analysis showing high incidence of cancers in patients with atherosclerotic cardiovascular diseases as compared with those with non-atherosclerotic cardiovascular diseases may imply a clinical possibility of a role of atherosclerosis in cancer developments. In the present study, to address our hypothesis that cancer developments may come with a strength of atherosclerosis, we traced an incidence of cancers in a total of 8,856 patients with coronary artery diseases (CAD) for a median follow-up of 1,095 days (interquartile range, 719-1,469 days) using the Sakakibara Health Integrative Profile (SHIP) database.

In accordance with a presence or absence of poly-arterial diseases such as aortic and/or peripheral artery diseases as an indicator of a strength of atherosclerosis, an incidence of cancers and all-cause death in two cohorts of 8,140 patients with CAD-only and 716 with CAD with poly-arterial diseases were evaluated to track an incidence of cancers and ali-cause mortality during median follou-up periods of 3 to 4 years.

Eligibility Criteria:
Inclusion Criteria:

* patients with diagnosed coronary artery diseases without a dignosis of cancers at the entry of SHIP between January 2009 and July 2014.

Exclusion Criteria:

* patients with diagnosed coronary artery diseases who had already been diagnosed with any cancers at the time of enrollment in the SHIP, and who were not followed-up after the entry of SHIP.
A Study of RO5045337 in Patients With Solid Tumors

This open-label, randomized, cross-over study will evaluate the effect of food on the pharmacokinetics of single oral doses of RO5045337 in patients with solid tumors. The anticipated time on study treatment is 3 weeks.


Eligibility Criteria:
Inclusion Criteria:

* Adult patients, \>/=18 years of age
* Histologically confirmed solid tumor
* Life expectancy of \>/=12 weeks
* ECOG performance status of 0 or 1
* Adequate bone marrow, renal and hepatic function

Exclusion Criteria:

* Patients receiving any other investigational agent or therapy administered with the intention to treat their malignancy within 28 days prior to study start
* Patients with pre-existing gastro-intestinal disorder
* Patients with uncontrolled intercurrent illness
The Role of Probiotics in Periodontal Disease

In this randomized controlled trial, it was aimed to evaluate the effect of probiotics (chewable tablets) and kefir consumption in the initial periodontal treatment of periodontitis patients on the change of oral microbiota and treatment. In this clinical trial, 36 systemically healthy volunteers who were diagnosed with periodontitis who were admitted to Gazi University Faculty of Dentistry, Department of Periodontology were included. Besides the inclusion criteria, the nutritional habits of the patients were evaluated by questionnaire. For diagnosis, plaque index, gingival index, bleeding on probing, periodontal probing depth and clinical attachment level were examined. Patients were randomly divided into 3 groups; probiotic, kefir and control group. Following the periodontal diagnosis, clinical index records of the patients and subgingival microbial samples were obtained. The supragingival plaque sample was removed and the subgingival microbial dental plaque sample was gently taken with a sterile Gracey curette. In the same session, periodontal initial treatment was started. According to the groups, they were involved simultaneously with the treatment, kefir group was advised to consume kefir as a liquid once a day in 14 days; probiotics group was advised to consume as a chewable tablet once a day in 14 days; the control group was advised without additional food supplements. Periodontal indexes were repeated in the 1st and 3rd months. Subgingival plaque samples were taken at baseline and at 3 months and DNA sequencing was performed for Tanneralla forsythia (T. forsythia), Porphyromonas gingivalis (P. gingivalis), and Treponema denticola (T. denticola).


Eligibility Criteria:
Inclusion Criteria:

1. Systemically healthy
2. Individuals over 18
3. Periodontitis (4-6 mm pockets) patients with 3 teeth in each half of the jaws except wisdom tooth
4. Non-smoker
5. Not using probiotic tablets/capsules and consuming no more than 3-4 probiotic food.

Exclusion Criteria:

1. Antibiotic use within 6 months.
2. Breastfeeding or pregnancy.
3. Acute oral lesions or necrotizing ulcerative periodontitis
4. Diabetes, rheumatic fever, lung, kidney disease history and drug use that will affect periodontal tissues
5. Patients who smoke or who did not stop until last year
6. Use of probiotics tablets or capsules
7. Probiotic food consumption not more than 3-4 times a week
Effectiveness of Using Jiu-Jitsu for Coping With Medical Violence in Healthcare Workers

Workplace violence in hospitals and other health care settings is a troublesome issue and has severe consequences for the entire health care system. In recent years, workplace violence has made a great threat to nurse assistants. Therefore, violence prevention education is a part of medical personnel's job responsibility. However, a theory-based violence prevention education program for healthcare settings was limited. The aim of the study is to investigate the effects of experiential learning theory-based medical jujitsu training on perception on violence, attitude on violence, self-efficacy, and turnover intention among nurse assistants


Eligibility Criteria:
Inclusion Criteria:

* Licensed healthcare professionals

Exclusion Criteria:

* Non-licensed healthcare professionals
Study of the Effect of Ivacaftor on Lung Clearance Index in Subjects With Cystic Fibrosis and the G551D Mutation

The purpose of this study is to evaluate the effect of ivacaftor (VX-770) on lung clearance index (LCI) in subjects aged 6 years and older with cystic fibrosis (CF) who have the G551D-CFTR mutation on at least 1 allele.

Currently, limited objective measures are available to quantify lung function in CF patients with mild lung disease. Lung clearance index (LCI) derived from inert gas multiple-breath washout (MBW) testing hold considerable promise to evaluate early lung disease as studies have detected abnormalities in a high percentage of CF patients with normal spirometry in both infants and children.

This study explored the effect of ivacaftor on LCI and the efficacy of ivacaftor on other clinical and biomarker endpoints of CF lung disease in subjects aged 6 years and older with CF who have the G551D-CFTR mutation on at least 1 allele.

Eligibility Criteria:
Inclusion Criteria:

* Male or female subjects with confirmed diagnosis of CF
* Must have the G551D-CFTR mutation in at least 1 allele
* FEV1 \>90% of predicted normal for age, gender, and height

Exclusion Criteria:

* Ongoing participation in another therapeutic clinical study or prior participation in an investigational drug study within the 30 days prior to screening
* Use of inhaled hypertonic saline treatment within 2 weeks of the Period 1, Day 1 visit
A Mechanistic Study of Inhaled Nitric Oxide in COPD

There is a lack of effective treatments for chronic obstructive pulmonary disease (COPD) complicated with pulmonary hypertension. Previous studies have found that inhaled nitric oxide (iNO) can reduce pulmonary artery pressure and improve exercise capacity in COPD with pulmonary hypertension patients. However, the specific mechanism is unclear. The study aims to evaluate pulmonary ventilation/perfusion, pulmonary artery pressure, oxygenation, symptoms and quality of life in COPD with pulmonary hypertension patients after short-term treatment with iNO. Observing a series of pathophysiological changes caused by the treatment of pulmonary hypertension with iNO in COPD, the investigators hope to provide new theoretical basis and research ideas.


Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 40 years, ≤ 75 years
2. Currently smoking or former smokers with at least 10 pack-years of tobacco cigarette smoking history
3. Diagnosis of moderate and severe COPD by the Global initiative for chronic Obstructive Lung Disease (GOLD) 2022 criteria: A post-bronchodilatory forced expiratory volume in 1 second/forced vital capacity (FEV1/FVC) \< 0.7, and 30%\< FEV1 \< 80% predicted
4. Echocardiogram with technical adequacy demonstrating with Pulmonary Hypertension: Tricuspid regurgitation velocity (TRV) \> 2.8 m/s or pulmonary arterial systolic pressure (sPAP) ≥38mmHg
5. Signed informed consent prior to the initiation of any study mandated procedures or assessments

Exclusion Criteria:

1. Experienced an exacerbation requiring start of or increase in systemic oral corticosteroid therapy during the last month
2. Treatment with antibiotics
3. Respiratory failure requiring supplemental oxygen therapy
4. A diagnosis of Interstitial lung disease, asthma, tuberculosis, bronchiectasis, pneumonia, lung cancer, pulmonary embolism, or other non-COPD respiratory disease
5. Any history of lung resection
6. Left ventricular dysfunction: left ventricular ejection fraction (LVEF) \< 40%
7. Clinically significant valvular heart disease, including aortic valvular disease (moderate or greater aortic stenosis or regurgitation) and/or mitral valve disease (moderate or greater mitral stenosis or regurgitation), or status post mitral valve replacement
8. Use within 30 days of screening or current use of approved PH medications such as sildenafil, bosentan or prostacyclines
9. Neuromuscular disease or musculoskeletal injuries that unable to complete exercise trials
10. Use of investigational drugs or devices within 30 days prior to enrollment into the study
11. Any underlying medical or psychiatric condition that, in the opinion of the Investigator, makes the subject an unsuitable candidate for the study
Immediate Implant Outcomes With and Without Bone Augmentation

To evaluate immediate implant placement feasibility and esthetic outcomes in severely damaged sockets that received simultaneously bone reconstruction (cortical bone shield) and implant placement versus intact sockets that needed no reconstruction and had immediate implant placement.

The present clinical trial aims at demonstrating facial bone regeneration on sites that presented large buccal bone dehiscences \& vertical bone loss and evaluate the feasibility of performing simultaneous bone augmentation and implant placement, comparing the outcomes with sites that had intact sockets that did not require reconstruction. A secondary objective was to evaluate pink esthetics and marginal bone levels at final follow-up.

Eligibility Criteria:
Inclusion Criteria:

* individuals 20 Years and older
* Patients requiring single implants to replace missing teeth to restore masticatory function and esthetics.
* ASA1 or ASA2 (American Society of Anesthesiologists)
* Healthy individuals with good oral hygiene and motivation
* No systemic uncontrolled diseases
* Not taking drugs known to modify bone metabolism

Exclusion Criteria:

* Individuals with untreated \& generalized severe periodontitis
* Smokers (\>5 cigarettes/day)
* Poor oral hygiene
* Diabetes (HbA1C \>6.5% as cutoff value)
* Uncontrolled cardiovascular disease
* Poor overall health (ASA IV)
Defining Benchmarks for Gastric Cancer Patients Underwent Minimal Invasive Gastrectomy

The Benchmark-MISGC study was a large-scale retrospective observational study launched by the China Gastric Cancer Surgical Union, aiming to establish the benchmarks of the short- and long-term outcomes for gastric cancer patients who underwent minimal invasive gastrectomy.


Eligibility Criteria:
Inclusion Criteria:

1. Patients with postoperative histologically confirmed gastric adenocarcinoma at stages T1-4a, N0/+, M0;
2. underwent robotic or laparoscopic gastrectomies with curative intent

Exclusion Criteria:

1. ASA class \> 3;
2. remnant gastric cancer;
3. concurrent/previous malignant disease;
4. Distant metastasis;
5. Palliative resection;
6. Abodominal exploration.
Telehealth Lifestyle Program for Black Adolescent Girls at Risk for Type 2 Diabetes

The aim of this study is to look at changes in diabetes-related risk factors in Black adolescent girls who are at risk for type 2 diabetes and their primary female caregiver after both participating in a 12-week telehealth lifestyle program.

Enrolled adolescent/caregiver dyads will participate in the 12-week program. Each week, participants will engage in 2 activities: a live virtual Wellness Session and an at-home cooking experience using ingredients sent to them via grocery delivery service.

The study will examine the pre-post difference in overall diet quality, dermal carotenoid levels, physical activity, body composition, and glycemic measures among at-risk black adolescent girls and their caregivers. Investigators hypothesize that after the program, participants' diets will be higher in quality than before.

Eligibility Criteria:
Inclusion Criteria for adolescent participants:

* 12-18 years of age
* self-identify as Black or African American
* have obesity

Exclusion Criteria of adolescent participants:

* pregnant or within 3 months postpartum.
* participated in a formal weight management program within 6 months prior to study.
* currently taking medications or diagnosed with a condition known to influence metabolism, physical activity ability, or cognitive function.
* have previously undergone bariatric surgery.
* have type 2 diabetes.
* unable to speak English or have developmental conditions that interfere with ability to communicate.

Inclusion criteria of caregiver participants:

* 18 years or older.
* proficiency in speaking English.
* live in the same household as the adolescent who will also be enrolled
* prepares the majority (\>50%) of meals in the household

Exclusion Criteria of caregiver participants:

* pregnant or within 3 months postpartum.
* unable to speak English or have developmental conditions that interfere with ability to communicate.