cyrilzakka/clinical-trials huggingface dataset:
Effect of Photobiomodulation on the Treatment of Soft Tissue Traumatic Injuries

Soft tissue injuries are directly related to the energy of the trauma and its repair is the main factor for bone healing and the recovery of the function of the affected limb. Photobiomodulation (PBM) is indicated as an adjuvant treatment to accelerate wound healing, however, there is still a lack of evidence regarding its effect on traumatic soft tissue injuries. This project aims to evaluate the effects of the application of PBM in the resolution of complex soft tissue injuries of traumatic origin associated with tibial fractures. 84 adult individuals, aged between 18 and 60 years, hospitalized with tibial fractures awaiting resolution of soft tissue injuries will be included to undergo definitive surgery. The subjects will be randomized in two groups: PBM (treated with a device with 144 LED emitting diodes at wavelengths of 420, 660 and 850nm, 3J per point for 10 minutes) and Sham (simulation of the LED application, with a device with characteristics identical to that of the PBM group, for the same period of time). Subjects will be treated daily until release for surgery. The primary outcome will be the assessment of the wound healing process using the BATES-JENSEN scale. Secondary outcomes will be: pain intensity; consumption of analgesic drugs; serum evolution of inflammatory markers C-reactive protein and creatine kinase, measurement of the lesion area, time needed for release for definitive surgery, presence of infection, and the cost-effectiveness of PBM. The evaluations will be carried out before the beginning of the intervention and daily until the participant is considered ready for surgery (which will be considered the end of the experimental period). Data will be analyzed statistically considering a significance level of 5%.


Eligibility Criteria:
Inclusion Criteria:

* Adult individuals of both sexes, aged between 18 and 60 years;
* Interned in the Orthopedics and Infirmary Emergency Room of the Surgical Clinic of Conjunto Hospitalar do Mandaqui;
* Victims of high-energy trauma in the lower limbs with sufficient soft tissue injury to make primary closure unfeasible or definitive treatment of injuries in the initial care associated with tibial fracture.

Exclusion Criteria:

* Diagnosis of chronic systemic diseases (renal failure, diabetes mellitus, hypertension, peripheral vascular insufficiency);
* Allergy to cefazolin and gentamicin;
* Uncontrollable active bleeding;
* Occlusive arteriopathies;
* Compartmental syndrome;
* Necrosis in the area of neurovascular injury with sensory deficit at the injury site;
* History of previous surgeries on the affected limb;
* Local or systemic changes that contraindicate surgical intervention or hinder the postoperative period;
* Smoking;
* Photo sensitivity history;
* Neurological and psychiatric disorders;
* Use of anti-inflammatory drugs in the last 15 days prior to the trauma;
* Pregnant women.
Treatment of Tempromandibular Joint Anterior Disc Displacement With Different Materials

comparing the clinical efficacy of intra-articular injection of platelet lysate (PL), versus Hyaluronic Acid after arthrocentesis in the management of patients with anterior disc displacement with reduction.


Eligibility Criteria:
Inclusion Criteria:

* Patients that will be diagnosed with anterior disc displacement with reduction (ADDWR) both clinically and through magnetic resonance imaging scan (MRI).
* Patients who will not respond to a previous conservative therapy.
* Patients with pain in temporomandibular joints.
* Patients with normal or limitation in mouth opening.
* Patients with clicking sound.

Exclusion Criteria:

* Patients with previous invasive TMJ surgical procedures.
* Patients with inflammatory or connective tissue diseases.
* Patients with neurologic disorders.
* Patients with history of bony or fibrous adhesion.
* Patients having gross mechanical restrictions and condylar fractures.
* Patients with psychological problems.
* Patients receiving anti-coagulation treatment, non-steroidal anti-inflammatory drugs within 48 hours pre-operatively, corticosteroid injection at the treatment site within one month or systemic use of corticosteroids within 2 weeks.
CODY: A Study Evaluating The Safety And Efficacy Of QTORIN 3.9% Sirolimus Topical Gel For The Prevention Of Basal Cell Carcinomas (BCCs) In Patients With Gorlin Syndrome

A Phase 2b study looks at the safety and efficacy of a treatment that is being investigated for people with certain diseases. This study will be conducted at multiple centers in the United States where participants with Gorlin Syndrome, also known as basal cell nevus syndrome, will be randomly placed into two groups; one group will receive the active topical gel, the other a topical vehicle gel, also know as placebo. Participants will apply this topical product to their face once a day for 6 months. The study will be looking at the number of new BCCs that develop on the faces of all the participants during this time.


Eligibility Criteria:
Key Inclusion Criteria:

* Adults, 18 years or older
* Meet diagnostic criteria for Gorlin Syndrome
* Willing to avoid application of a non-study topical medication to the face (prescription or over the counter) during the study.
* Willing to forego treatment of BCCs with anything other than the study medication except when the Investigator believes that delay of treatment of a BCC potentially might compromise the health of the subject. During the trial, the only allowed form of BCC treatment is surgical.
* Participant will be encouraged to use their preferred sunscreen with a sun protector factor (SPF) of at least 30 daily

Key Exclusion Criteria:

* Recently participated in a clinical trial evaluating an investigational product for the treatment of BCCs or Gorlin Syndrome within 3 months prior to to starting study medication. Participant can start the study screening period prior to completing the 3 month washout.
* Recently used topical or systemic (oral) treatment that might interfere with the evaluation of the study medication.
Audiological Evaluation of Anesthetists

The investigators aim to investigate the effect of operating room noise on anesthetist hearing


Eligibility Criteria:
Inclusion Criteria:

* anesthetist doctor and non-anesthetist doctor less than 40 years

Exclusion Criteria:

* doctors above 40 years
Protective and Risk Factors for QoR-15 for Major Abdominal Surgery

Investigation of post-operative recovery among adult patients receiving major abdominal surgery.

This prospective observational clinical trial aims to evaluate the postoperative recovery status of patients undergoing major abdominal surgery using the Quality of Recovery-15 (QoR-15) questionnaire. The QoR-15 has been highly regarded for its importance and research value in evaluating postoperative recovery in previous studies and has been validated in numerous languages, including Mandarin. Furthermore, the QoR-15 is not only a reflection of the subjective recovery quality but has also been found to be associated with objective indicators such as postoperative complications. Therefore, establishing a database of postoperative QoR-15 variations can play a significant role in improving healthcare quality and serves as a validation indicator for many Enhanced Recovery After Surgery (ERAS) outcomes. The study aims to contribute to improving postoperative care and inform future research in the context of ERAS programs..

Eligibility Criteria:
Inclusion Criteria:

* (1) Age 18years and above.
* (2) Undergoing elective abdominal surgery with an expected surgical time of at least two hours and an expected hospital stay of at least two days.

Exclusion Criteria:

* (1) Age under 18 years. (2) Incapacity to give informed consent. (3) Emergency surgery.
Detection Of Monocytes/Macrophages Function And Tim-3 Expression In Septic Patients

The imbalance between anti- and pro-inflammation often occurs in patients with sepsis. And continuous such imbalance could lead to immunoparalysis, which is characterized by loss of delayed type hypersensitivity, failure of primary infections eradication, and a predisposition of secondary nosocomial infections development. However, in which phase of sepsis does immunoparalysis occur is still unknown. So this study aims to tentatively understand this problem by checking monocytes/macrophages' antigen presentation and cytokine secretion，and by checking monocytes/macrophages' expression of Tim-3 (the T cell transmembrane, immunoglobulin, and mucin-3), which is an inhibitory regulatory molecule, in sepsis patients' peripheral blood mononuclear cells.


Eligibility Criteria:
Inclusion Criteria:

* age over 18 years old;
* Fulfilled at least two criteria of systemic inflammatory response syndrome (a) core temperature higher than 38 ℃ or lower than 36 ℃ (b)respiratory rate above 20/min, or carbon dioxide partial pressure below 32 mmHg (c) pulse rate above 90/min, and (d) white blood cell count greater than 12,000/μl or lower than \< 4,000/μl or less than 10% of bands.
* Clinically suspected infection;

Exclusion Criteria:

* were under 18 years of age;
* were refused by the patients or his/her familiality;
* were suffering from acquired immunodeficiency syndrome,viral hepatitis,autoimmune diseases and hematology;
* use medicine which can affect immune system,such as Glucocorticoid and Immunosuppressant
* died within 24h after being taken into the ICU, or refused to get involved in the study, or gave up treatment during the period of observation
Rotavirus vs. Sucrose for Vaccine Injection Pain

This randomized trial will compare the analgesic effectiveness of oral rotavirus vaccine to sugar water for reducing vaccine injection pain in infants.


Eligibility Criteria:
Inclusion Criteria:

* healthy infants receiving rotavirus vaccine in conjunction with primary immunizations in the first 6 months of life

Exclusion Criteria:

* impaired neurological development, history of seizures, sedatives or narcotics in preceding 24 hours, parent unable to use study tools, prior participation in the trial
Monitoring of Pediatric Inflammatory Bowel Diseases Using Multispectral Optoacoustic Tomography

In this clinical trial, the intestinal wall of pediatric patients with Crohns disease and Ulcerative Colitis will be assessed with multispectral optoacoustic tomography (MSOT) to characterize the optoacoustic signal of the intestinal wall and to monitor disease activity.

The goal of this clinical trial is to compare the optoacoustic signal in the intestinal wall of children with inflammatory bowel diseases. The main questions it aims to answer are:

* How does the optoacoustic signal in children with inflammatory bowel diseases change over time?
* How does the optoacoustic signal in children with inflammatory bowel diseases change when they receive therapy? Participants will be examined with multispectral optoacoustic tomography.

In this study, the disease activity of children and adolescents with inflammatory bowel disease (IBD) will be assessed non-invasively by multispectral optoacoustic tomography (MSOT). IBDs play an important role in pediatric and adolescent medicine. The most common entities in the IBS group are Crohn's disease (CD) and ulcerative colitis (UC). Patients with CD develop chronic intermittent transmural inflammation of the gastrointestinal (GI) tract. Symptoms include diarrhea, hematochezia, abdominal pain, and malnutrition. Complications of the disease include fistula formation, perforations, and bleeding.The basis for many clinical decisions is the detection of disease activity.There are limitations to previous imaging methods for routine monitoring that are particularly relevant in pediatric and adolescent medicine.The use of contrast media, sedation, and invasive procedures are a burden for pediatric patients\*.Multispectral optoacoustic tomography (MSOT) offers a radiation-free and noninvasive alternative for detecting disease activity. Quantitative assessment of hemoglobin signal in the bowel wall of patients with CD could previously be correlated with endoscopically detected disease activity. The aim of this study is to evaluate whether MSOT also allows monitoring of chronic inflammatory diseases in children. For this purpose, children in different stages of disease who regularly receive intravenous therapeutic administrations of biologics (e.g. infliximab) in our hospital will be examined. The investigators think that by means of MSOT different stages and courses of the diseases could be measured non-invasively and thus invasive measures in children could be reduced.

Eligibility Criteria:
Inclusion Criteria:

* Existing diagnosis of CD or UC, or suspected CD or UC at initial diagnosis.
* Age 2 - 18 years
* Written declaration of consent from parents / legal guardians

Exclusion Criteria:

* Pregnancy
* Nursing mothers
* Cardiopulmonary unstable patients\*: Need for continuous cardiopulmonary monitoring
* Tattoo in the area of the examination field
* Subcutaneous fat \> 3 cm
Risk of Falls in Patients With Fibromyalgia

Fibromyalgia is a chronic illness characterized by persistent widespread muscle pain with generalised hyperalgesia and allodynia. It can be accompanied by other concomitant symptoms: fatigue, sleep disturbances, musculoskeletal disorders, distress and psychological disorders. The prevalence has been reported to be between 2 and 5%.

The hypothesis of this study is that women with fibromyalgia present high risk of falls and balance disorders compared with healthy women. The objective of this study was to investigate wether gait pattern changes in single and dual task conditions were associated with the risk of falling in women with fibromyalgia.

Falls and fall-related injuries are a common health problem. A fall is often a result of intrinsic physiological ageing and underlying chronic disease interacting with the external and challenging environment. Disturbances in physical function, muscle strength, range of motion, poor balance, affectation in sensory system, a loss of proprioception, alteration concerning visual and vestibular aspects, dizziness, decreased endurance and cognitive and mobility impairment are the most common risk factors for falls. Postural control in a dual task setting is especially relevant to daily life situations. Attending to that, we propose an assessment based on these parameters in women with fibromyalgia.

Eligibility Criteria:
Inclusion Criteria:

* Women diagnosed with fibromyalgia attending to the Fibromyalgia Association of Granada.
* Women who can complete the assessment battery of tests and tasks.

Exclusion Criteria:

* Auditive and visual disturbances.
* Cognitive problems.
* Psychiatric pathology.
* Gait serious disturbances.
* Concomitant neurological conditions
12-Month Open-Label Extension Study of Intepirdine (RVT-101) in Subjects With Alzheimer's Disease: MINDSET Extension

This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001 (double-blind study).

This 12-month open-label study will provide further information regarding the long-term safety and tolerability of intepirdine (RVT-101) for subjects with Alzheimer's disease who have completed the double-blind, placebo-controlled, lead-in study RVT-101-3001. Various background therapies, including acetylcholinesterase inhibitors and memantine, will be allowed.

Eligibility Criteria:
Inclusion Criteria:

* Completed last on-treatment visit of the lead-in study RVT-101-3001

Exclusion Criteria:

* Any clinically relevant concomitant disease, which, in the opinion of the investigator, makes the subject unsuitable for inclusion in the study.
Field Trial of a Relapse Prevention Program for Adolescents Receiving Substance Use Treatment

The purpose of this study is to provide a comprehensive evaluation of the new, Navigating my Journey program for adolescents receiving treatment in an outpatient substance abuse center.

The primary hypotheses are that, relative to the control condition, Navigating my Journey will be associated with significantly higher motivation, higher self-efficacy, improved relapse coping skills, and lower substance use. The secondary hypotheses are that, relative to the control condition, Navigating my Journey will be associated with increased therapeutic alliances with counselors.

The randomized, control trial will compare clients receiving treatment in an outpatient substance abuse center in the following two conditions -- (1) Experimental: Navigating my Journey (includes 12 core lessons and 8 supplemental lessons); and (2) Attention Control (treatment as usual plus online health information) -- using a longitudinal design.

Eligibility Criteria:
Inclusion Criteria:

* currently meeting with a counselor in the study at least twice per month during the next 3 months
* age 13 to 21
* ability to read and speak English
* have drugs and/or alcohol as their primary or secondary substance used
* have completed detox as necessary
* an active email account.
Virtual Celiac Symptoms Study in Adults and Teenagers

The goal of this study is to better understand the symptoms and impacts of celiac disease (CeD). Participants use a smart phone online app to answer daily questionnaires about symptoms and life with CeD for 12 weeks. There are no blood draws, gluten challenges, medications, or doctor visits required.

This is an observational, prospective study to measure symptoms and impacts of CeD.

This study will assess CeD symptom patterns over a 3-month observation period. The study will enroll approximately 400 participants.

The data will be prospectively collected, via a self-reported ePRO platform accessible by smartphone.

This virtual study will be conducted in the United States.

Eligibility Criteria:
Inclusion Criteria:

1. At least 12 years of age or older.
2. Diagnosed with CeD for at least 1 year.
3. For participants diagnosed over the age of 18: Biopsy confirmed diagnosis with CeD (participant reported).
4. For participants diagnosed under the age of 18: Blood test or biopsy confirmed diagnosis with CeD (participant reported).
5. Currently following a gluten free diet (GFD) for at least 6 months.
6. Has experienced symptoms believed by the participant to be CeD related in the last 3 months.
7. Has daily access to a smartphone as well as internet/Wi-Fi/cellular data.
8. Speaks and reads English.
9. Lives in the US (participant reported).

Exclusion Criteria:

1. Currently involved or planning to be involved in any clinical studies with an investigational drug, surgical procedure, or gluten challenge over the 3-month observation period.
Effect of Forward Head Posture(FHP)on Temopromandibular Joint (TMJ) Proprioception in Post-pubertal Females

No studies up to date has been evaluated the effect of FHP on TMJ proprioception.Therefore, this study will be the first one which aims to investigate the effect of FHP on TMJ proprioception in post-pubertal females

Forward head posture and temporomandibular disorder are two common problems in post-pubertal females. They are closely related to each other. Previous studies showed influences of head posture on the mandibular rest position, range of functional movements and the jaw and neck muscles work together during rhythmic movements. They affirm that patients with TMD present more alterations in head positioning than patients with no dysfunction .

However, no studies up to date has been evaluated the effect of FHP on TMJ proprioception. The proprioceptors in the human TMJ play important key role in identification of mandibular position when the teeth are not occluded. TMJ receptors provide the greater afferent activity regarding perceptual awareness of joint position and movement . Proper assessment of TMJ proprioception may be critical for designing not only rehabilitation but also pre-habilitation interventions for patients with FHP aiming to prevent TMD. Therefore, this study will be the first one which aims to investigate the effect of FHP on TMJ proprioception in post-pubertal females. This study may expand the role of physiotherapy in woman's health.

Eligibility Criteria:
Inclusion Criteria:

1. They should be at least 1 year post-puberty.
2. Their age will range from 14 to 19 years old.
3. Their body mass index (BMI) will range from 18-25 kg/m2.
4. They should spend long period of time with bad posture on computer, laptop or smart phones.

Exclusion Criteria:

* They shouldn't have headache, migraine, vertebra-basilar insufficiency,temporo mandibular disorders (TMD) ,uncorrected impairment of vision or audition, neck pain, fixed or mobile spinal deformity or history of fracture or surgery of the upper quadrant of the body
Electrical Impedence Tomography With ENLIGHT2100

Children with acute respiratory failure often need a breathing tube attached to a breathing machine, called a mechanical ventilator, to assist their breathing until they can recover. Once the cause of respiratory failure has resolved or improved enough, the breathing tube can be removed, and that is called extubation. The Extubation Readiness Test (ERT) is a simple evaluation commonly performed in the intensive care unit to determine if a child is ready to have the breathing tube removed.

The purpose of this study is to better understand how the ERT and the eventual removal of the breathing tube affect where the air is in the lungs, and whether this can help predict which children will succeed or fail having the breathing tube taken out. This can done be at the bedside with a device called electrical impedance tomograph. This novel device is painless and uses a belt fitted with sensors placed around the chest to show where the air is in the lungs.


Eligibility Criteria:
Inclusion Criteria:

* Patients less than 17 years of age admitted to the Duke Children's PICU or PCICU with acute respiratory failure due to a pulmonary illness will be considered eligible for the study

Exclusion Criteria:

* Patients with corrected gestational age less than 37 weeks
* Patients with contraindications to the ENLIGHT device (i.e. temporary or permanent pacemaker, vagal nerve stimulator, automatic implanted defibrillator, chest tubes that interfere with electrode belt placement, open chest wounds, unstable thorax, severe chest wall deformities)
* known pregnancy
* Patients previously enrolled in this study will be excluded from participation.