cyrilzakka/clinical-trials huggingface dataset:
ENDOmetriosis Robotic Assisted Surgery

The purpose of this study is to compare the robot-assisted approach with the laparoscopic approach in terms of reducing the rates of intraoperative and postoperative complications in patients undergoing total hysterectomy for DIE and adenomyosis without digestive tract involvement.

The ENDO-RAS trial aims to evaluate the safety and effectiveness of robot-assisted laparoscopy compared to conventional laparoscopy for hysterectomy in patients with Deep infiltrating endometriosis and adenomyosis without digestive tract involvement, as verified by magnetic resonance imaging and classified using both the ENZIAN and Deep Pelvic Endometriosis Index classifications. These classifications are used to evaluate Deep infiltrating endometriosis and reproducibly predict the occurrence of postoperative complications.

Eligible patients will be recruited from the gynecological surgery department after meeting the inclusion and non-inclusion criteria and signed informed consent forms. Participants will then be randomly assigned to receive either robot-assisted total laparoscopic hysterectomy or total laparoscopic hysterectomy.

The ENDO-RAS Trial is a multicenter, randomized, controlled, and open-label study. Eligible patients will be randomized into two parallel groups.

Eligibility Criteria:
Inclusion Criteria:

* ≥ 18 years of age.
* Diagnosed adenomyosis, either internal or external (magnetic resonance imaging) per the Enzian and dPEI classifications.
* Diagnosed deep infiltrating endometriosis per the Enzian and dPEI classifications, without the involvement of the digestive tract.
* Failure of first- and second-line medical treatment.
* Eligibility for total hysterectomy with complete removal of endometriosis lesions.
* Participants covered by entitled to social security.
* All participants must provide written informed consent before undergoing the surgical procedure.

Exclusion Criteria:

* Digestive tract involvement.
* Adenomyosis only.
* Contraindications to surgery.
* Participants who are under guardianship, curatorship, or deprivation of liberty.
The Effect of Different Virtual Reality-Based Exercise Trainings on Pulmonary Function, Respiratory and Peripheral Muscle Strength, Functional Capacity and Balance in Children With Bronchiectasis

Bronchiectasis is defined as abnormal, chronic and permanent enlargement of one or more bronchi. Disease symptoms; often productive cough, dyspnea, fatigue and wheezing. Changing pulmonary mechanics, inadequate gas exchange, decreased muscle mass and associated psychological problems may cause dyspnea, decreased exercise capacity and health-related quality of life. Exercise training as a part of pulmonary rehabilitation is used to reduce the severity of symptoms; is an effective treatment to improve exercise capacity and health status. Virtual reality based exercise training has taken its place in many areas of rehabilitation as a current and new approach. In the studies in the literature, Nintendo Wii Fit games are an effective, motivating, entertaining and clinically useful method for reducing symptoms in the rehabilitation of chronic lung diseases. Wii Fit games generally include strengthening, aerobics and balance exercises. Developed by BreathingLabs, Breathing Games, which is based on breathing exercises, are a new product, a virtual reality application that has been included in a limited number of studies, has shown its effect on reducing respiratory problems and is open to research effects for many patient groups. The importance of this study is that it will be the first study on Nintendo Wii Fit games based exercise training and Breathing Games based breathing exercises training in children with bronchiectasis.

The aim of this study is to investigate the effect of different virtual reality-based exercise trainings on pulmonary function, respiratory and peripheral muscle strength, functional capacity and balance in children with bronchiectasis.


Eligibility Criteria:
Inclusion Criteria:

* Bronchiectasis diagnosis
* Stable clinical condition (no exacerbation in last 4 weeks)

Exclusion Criteria:

* Documented diagnosis of vestibular, neurological or orthopedic disorders which may affect balance and mobility
* Subjects previously involved in exercise training or physiotherapy programs
* Previous history of lung or liver transplantation
Autonomic Activity During Nap Under Hypoxia

Sleeping under hypoxic conditions can impair cognition and autonomic nervous activity. A short daytime nap can modify these changes. Here we propose a randomized, cross-over study to evaluate the heart rate variability during a 90 min nap in a normobaric hypoxic chamber. In addition, we will investigate sleep architecture, vigilance, attention and memory.


Eligibility Criteria:
Inclusion Criteria:

* Men and women
* Age 25-45 years
* BMI 20 - 28 kg/m\^2

Exclusion Criteria:

* Severe, manifest illnesses in need of treatment
* Postoperative phases
* Acute and chronic infections
* Sleep disorders such as sleep apnea, insomnia or somnolence
* Altitude exposure (\> 2500 m asl) within 6 months before enrollment
* Regular migraines
* Smoking
* Athletes
* Significant weight change within 1 month before enrollment
* Inability to understand significance and scope of the study
* Drug or alcohol abuse
Enhancing School-Based Violence Prevention

The purpose of this study is to compare two versions of Mental Health Enhanced Positive Behavioral Interventions and Supports in reducing aggression in middle school students.


Eligibility Criteria:
Inclusion Criteria:

* for student participants: in 6th and 7th grades in a study school at study entry
* for teacher participants: teacher at a study school

Exclusion Criteria:

* .for student participants: intellectual disabilities, very limited reading abilities, or in foster care
Investigation of the Relationship Between Development, Neurological Assessment and Object Permanence in High Risk Infants.

The aim of the study is to examine the relationship between development, neurological assessment and object permanence in risky infants aged 7-16 months. The sample of the study will consist of babies between 7-16 months at risk (preterm, low birth weight, asphyxia, hyperbillirubinemia, etc.). Inclusion criteria for the study: Between 7-16 months, having at least one risk factor. Exclusion criteria: Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder. Parents who agreed to participate in the study will be asked to fill out the demographic information questionnaire. Object permanence scale, Bayley III infant and toddler development scale and Hammersmith infant neurologic assessment will be applied to infants.


Eligibility Criteria:
Inclusion Criteria:

* Between 7-16 months, having at least one risk factor

Exclusion Criteria:

* Medical complications (eg, severe visual impairment) limiting participation in assessments; autism, down syndrome, or spinal cord injury; diagnosed uncontrolled seizure disorder; or a neurodegenerative disorder
Evaluating a Low-Literacy Discharge Medication Education Tool

Recent studies have demonstrated that patients sub-optimally understand hospital discharge medication instructions Health literacy has been shown to be an important factor in patient understanding of medical information , and following medication instructions.

The primary aim of this project is to test the efficacy of a low-literacy discharge medication education tool on medication adherence, and patient knowledge and understanding of inpatient discharge medications, in a low-income population with low health literacy levels. This evaluation is a prospective trial with patients randomly assigned to either receiving this tool or receiving the current standard of care. Given the complexity of the discharge medication regimen for the conditions of congestive heart failure (CHF) and coronary artery disease (CAD), and the proven effectiveness of these medications in the post discharge period, this trial will focus on the subpopulation of patients hospitalized with these two conditions.


Eligibility Criteria:
Inclusion Criteria:

Patient inclusion criteria will be:

* 18 years of age or greater
* Admission to the internal medical or cardiology services at LAC/USC Medical Center
* Discharge directly from the medical service to home
* During admission, being evaluated or treated for congestive heart failure or coronary artery disease.

Patient Exclusion criteria :

* Moderate or severe cognitive dysfunction
* Severe psychiatric disability such that the patient has, or there is an application for, a conservator, or any psychiatric illness with current psychotic features
* Not having speaking proficiency in either English or Spanish language.
* If the patient was previously enrolled in the study on a prior hospitalization, he or she will also be excluded.

Nurse Inclusion Criteria:

* Performing the patient education at hospital discharge for a patient enrolled in the study
Ultrasound Assessment of Clear Liquid Intake During Labour

We designed a two arms prospective, randomised, simple blinded trial to compare the impact of clear liquid intake on gastric content before delivery. We hypothesize that there will be no difference between the two groups, leading to safety of clear liquid intake during labour.

Gastric emptying is a major concern for anesthetists in obstetric. In order to prevent the risk of gastric aspiration, we are used to forbid to eat and to drink during labour.

However, this behaviour is controversial and some studies have shown that clear liquid intake can be safe during labour. Informations from a bedside ultrasound examination of the stomach content may be a useful tool to balance benefits and risks of such attitude. This technique has recently been shown very promising in pregnant women for the assessment of the gastric volume.

Eligibility Criteria:
Inclusion Criteria:

* Any pregnant woman at term

Exclusion Criteria:

* Pathologic pregnancy
* Twin pregnancy
* Body mass index above 35 kg/m2 before pregnancy
* Cervix dilation above 8 cm
* Refusal
European Survey of Non-Variceal Upper Gastro Intestinal Bleeding (NVUGIB)

The aim of this study is to assess the current management strategies in a pan-European "real-life" setting to uncover the unmet need in this area: non-variceal gastrointestinal bleedings.


Eligibility Criteria:
Inclusion Criteria:

* Patients admitted to the hospital or inpatients with an overt non-variceal upper GI bleed manifesting as hematemesis/coffee ground vomiting, melena, hematochezia, as well as other clinical/laboratory evidences of acute blood loss from the upper GI tract
* Evidence that an upper GI endoscopy was performed
* The complete medical record is available for study related hospitalization.

Exclusion Criteria:

* NA
Change in Patient-repOrted Outcomes in COPD Patients Newly Initiated on TRIXEO AEROSPHERE in Real worlD

The purpose of this study is to describe patients' clinical and self-reported outcomes of treatment with budesonide / glycopyrronium / formoterol Metered dose inhaler (BGF MDI) in Romania in real-life setting, up to 6 month of observation period. The study will focus primarily on the change in self-perceived health status in the first 12 weeks (3 months) of treatment with no pre-defined hypothesis.

This is a prospective, non-interventional, multi-centre study to investigate the change in patient-reported outcomes in moderate to severe COPD patients newly initiated on TRIXEO AEROSPHERE (budesonide / glycopyrronium / formoterol) in real-life setting in Romania. Furthermore, the patient satisfaction with the medication taken shall be assessed in the real-world setting; an important component that is not usually captured by RCTs. Patients with moderate to severe COPD who are eligible for BGF MDI therapy may be enrolled by physicians in the specialist care setting and the decision to prescribe BGF MDI must be independent of enrollment into the study.

This is a combined primary and secondary data collection study conducted to characterize the population of patients with COPD initiating triple therapy with BGF MDI in real-life setting. Thus, exposure data collected in this study will be primarily on BGF MDI treatment indicated for moderate to severe COPD patients as part of routine medical care. Primary data collection includes PROs; all other data will be documented based on the existing medical records (secondary data collection), either historically or throughout the period of 6-month follow-up, as part of the routine practical care of the patients.

Eligibility Criteria:
Inclusion Criteria:

* Physician-diagnosed COPD
* Initiated treatment with BGF MDI as prescribed according to the summary of product characteristics (SmPC) and local market reimbursement criteria;
* Patients must be able and willing to read and to comprehend written instructions, and to comprehend and complete the questionnaires required by the protocol
* After full explanation, patients must have signed an informed consent document indicating that they understand the purpose of, and the procedures required for the study and are willing to participate in the study

Exclusion Criteria:

* COPD due to known α-1 antitrypsin deficiency
* Previous treatment with triple fixed-dose combination in 12 months prior to baseline
* Hospitalization due to COPD exacerbation within the last 30 days prior to index date
* Pregnancy or lactation period
* Other uncontrolled disease, that might, in the investigator's opinion, influence the assessment for the current study
* Participation in a non-interventional, observational trial that might, in the investigator's opinion, influence the assessment for the current study, or participation in any interventional clinical trial in the last 30 days prior to baseline.
* Hospitalization for Covid-19 infection in the last 30 days prior to index date
Urban Health Study II

The study will test an intervention to help HIV-positive people achieve consistency of HIV care while transitioning in and out of jail.

The study has two research objectives: (1) to expand access and options for HIV testing with individuals in the criminal justice system, by focusing on high-risk intravenous drug users (IDUs) and crack cocaine smokers in community settings; and (2) to improve access and maintenance of highly active antiretroviral treatment (HAART) among HIV-positive persons in this population, by implementing a promising intervention focused on continuity of HIV care, and evaluating it using a rigorous experimental design.

HIV-positive persons will be identified through the testing activities described in Objective 1. They will then be offered enrollment in a randomized controlled trial (RCT) of an intervention designed to engage and maintain HIV-positive people with criminal justice involvement in medical care. The intervention, Project Bridge, has shown great promise but has not yet been rigorously evaluated. The RCT will assess the efficacy of Project Bridge compared with a Usual Care arm. Our hypotheses are that, at quarterly data collection visits: (1) Intervention participants will have lower HIV viral load than usual care participants 2b: (2) Intervention participants will be more likely to be in HIV care than usual care participants (3) Intervention participants will be more likely to be on HAART than usual care participants.

The study design was changed from a randomized controlled trial to a quasi-experimental comparison group design. This change was approved by the NIMH Program Officer and the RTI IRB in June, 2012.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older
* HIV antibody positive
* not currently receiving HIV care

Exclusion Criteria:

* already in care
* unable to provide informed consent
Clinical Performance of Zirconia Reinforced GI Versus Conventional Viscous GI in Geriatric Patients

This study is conducted to evaluate the clinical performance of Zirconomer Improved GI restoration compared to Conventional viscous GI restoration in geriatric patients with Posterior carious lesions in class I or II cavities

This study will be conducted to determine the clinical performance of the Zirconia reinforced glass ionomer restorations ( Zirconomer improved) under stress bearing posterior area (class I or claa II cavities) in geriatric population in comparison to Conventional viscous glass ionomer restorations (Ketac molar quick Aplicap) using the modified United States Public Health Service (USPHS) criteria

P: Geriatric Patients with posterior Caries lesions I: Zirconia reinforced GI (Zirconomer Improved) C: Conventional viscous GI, (Ketac Molar quick Aplicap) O: The Clinical performance of the Glass Ionomer restorations Using USPHS Criteria

Eligibility Criteria:
Inclusion Criteria:

* Age range 60-80 years
* Geriatric patients with Class I or II Posterior carious lesions.
* Males or Females.
* Pulp asymptomatic vital carious posterior teeth.
* Co-operative patients approving to participate in the trial.

Exclusion Criteria:

* Age range less than 60 years.
* Disabilities.
* Deep extensive carious cavities that may lead to fracture of the tooth or pulpal affection.
* Teeth with signs and symptoms of irreversible pulpitis or pulp necrosis.
* Heavy smoking.
* Lack of compliance.
The Effect of Platelet Rich Plasma on Pain at Skin Graft Donor Sites

The purpose of this study is to compare post-operative skin graft donor site pain between those treated with standard wound care vs PRP. Secondarily the study is designed to compare time to complete donor site healing. The null hypothesis is that here is no difference in post-operative donor site pain between those treated with standard wound care and PRP. The secondary null hypothesis is that there is no difference in time to donor site healing.

A well-known complaint after a split thickness skin graft surgery is pain at the graft donor site. In our patients, it has been have noticed those whose donor sites have been treated with platelet rich plasma (PRP) have endorsed decreased pain compared to those who have not. During our literature review few studies have looked at this issue. One such study by Miller et. al. looked at 5 patients whose donor site was treated with PRP showed a significant decrease in pain on a Likert visual pain scale. Kakudo et al. performed a side-by-side comparison on a single patient with half the wound treated with PRP and the other as a control. They found better epithelization and reduced pain during dressing changes for the treatment group. Both of these studies show promising results for pain reduction with PRP use, unfortunately there are no high quality randomized control trials that have looked at this. Another issue is many studies on PRP assess reduction of pain as a secondary outcome and instead focus on wound healing and epithelization primarily.

This study hopes to elucidate the effect of PRP application on graft donor site pain. Patients will be recruited to the study and randomized into either treatment or control group based on medical necessity for a skin graft. This study will assess pain at the donor site via Likert pain scale and monitor narcotic pain medication use.

Eligibility Criteria:
Inclusion Criteria:

* Any patient requiring a split thickness skin graft and is above the age of 18.

Exclusion Criteria:

* Medical history of chronic pain at the donor site
* Inability to follow up
* Unable to participate in pre or post operative questionnaire inclusive of organic
* Traumatic, chemical or degenerative causes of altered mental sensorium
* Age \<18.
Covert-saccades, Dynamic Visual Acuity and Quality of Life

Patients with chronic bilateral vestibular hypofunction may suffer from a visual instability during head movement called oscillopsia. Visual consequence of vestibular deficit can lead to a severe impairment of their quality of life. However, correcting saccades during rapid head movement, called covert-saccades, have been more recently identified. These saccades, which occur during the head movement in patients with vestibular hypofunction, present a very short latency. They could compensate for the lack of vestibular-ocular reflex and greatly decrease oscillopsia and visual impairment. The objective of this study is to evaluate the potential functional benefice of these compensatory movements in a population of 20 patients with chronic bilateral areflexia, in a cross-sectional study.


Eligibility Criteria:
Inclusion Criteria:

* Bilateral Vestibular Hypofunction (BVH) with at least two of the tree following criteria

  * Mean peak slow phase velocity of 5°/s or less in bilateral bithermal (30 and 44°C) caloric irrigations
  * Pathologic Head-impulse test
  * VOR gain of \<0.25 on rotatory chair tests
* Disorder present for over 6 month
* Comprehension of the experiments instructions
* Patient consent

Exclusion Criteria:

* Corrected Visual Acuity lower than 5/10
* Other conditions leading to oscillopsia or ataxia
* Oculomotor palsy, ocular instability in primary position
* Cervical rachis pathology with instability
* Cochlear Implants
* Non-stabilized medical disease
* Pregnant women
* Patients under tutelage
Evaluating Use of Microwave Technology to Differentiate Hemorrhagic Stroke From Infarction in the Acute Phase

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. Follow-up microwave measurements will be performed after the acute phase. The study assesses the diagnostic capability and safety of Strokefinder MD100.

This is a prospective, open, multicentre trial that will enrol patients with clinical signs of stroke in the acute phase admitted for CT scan. The investigator will assess and control the inclusion/exclusion criteria. If the patient is confirmed to be suitable for the trial, the patient is asked to give oral informed consent. If the answer is affirmative the microwave measurement will be performed. The procedure will take less than five minutes (the duration of the actual measurement procedure is 1.5 minutes) and will not interfere with the patient's standard of care during the hospital stay. Written informed consent is acquired by the investigator, as soon as possible after the acute phase of care is completed. Follow-up microwave measurements will be performed after the acute phase.

The measurement data will be evaluated for the presence of signal artifacts. The diagnostic ability of the device will be evaluated using a leave-one-out cross validation (LOOCV) method with the CT diagnosis as ground truth.

Safety will be evaluated throughout the trial, and a safety follow-up will be performed by the investigator 24 hours after the last microwave measurement. No further follow-up of patients is planned.

Eligibility Criteria:
Inclusion Criteria:

* Patient should be ≥ 18 years of age
* Patient has clinical signs of stroke
* Patient/next of kin confirms orally that the patient wants to participate in the trial (during acute phase)
* Signed Informed Consent Form (after acute phase)

Exclusion Criteria:

* Pregnant or nursing woman
* Fertile woman where pregnancy cannot be excluded
* Patient diagnosed with a condition associated with risk of poor protocol compliance
* The diagnostic procedure is deemed to interfere with the standard of care
* Any other condition or symptoms preventing the patient from entering the study, according to the investigator´s judgment
* Any patient that according to the Declaration of Helsinki is deemed unsuitable for study enrolment