cyrilzakka/clinical-trials huggingface dataset:
Combinaison of Virtual Reality and Rehabilitation to Improve Muscle Function, Exercise Tolerance, Exertional Symptoms and Dyspnea in Patients with Chronic Respiratory Disease: a Randomized Cross-over Trial

Chronic respiratory diseases, such as Chronic Obstructive Pulmonary Disease (COPD), are a leading cause of death globally. These diseases not only contribute significantly to mortality but also lead to a decline in physical capacity, limiting daily activities and perpetuating a vicious cycle of deconditioning. Dyspnea (shortness of breath) is a major symptom, seen in 56 to 98% of COPD patients, and is linked to decreased exercise tolerance and muscle dysfunction. It often leads to reduced physical activity, further worsening respiratory function and quality of life. Dyspnea severity is associated with increased mortality, hospitalizations, and anxiety. The main therapeutic approach for these patients is pulmonary rehabilitation, which improves exercise tolerance, quality of life, and reduces hospitalizations and exacerbations. However, dyspnea limits exercise and is often a barrier to continued physical activity.

Virtual reality (VR) technology has shown promise in managing symptoms like pain, anxiety, and dyspnea by providing a distraction. Studies suggest that VR can improve dyspnea and anxiety, particularly in patients hospitalized for conditions like COVID-19. However, research on VR's immediate effects on exercise capacity is limited, with most studies focusing on non-immersive exergames rather than immersive VR. The potential of VR to improve exercise tolerance in patients with chronic respiratory diseases remains uncertain. Our study aims to test this hypothesis through a randomized crossover trial to assess VR's impact on dyspnea and exercise tolerance in these patients.


Eligibility Criteria:
Inclusion Criteria:

* Patient aged 18 years or older
* Patient with a chronic respiratory disease requiring pulmonary rehabilitation
* Patient with dyspnea assessed as mMRC ≥ 0 (Annex 3)
* Patient undergoing pulmonary rehabilitation at the Paris Saint-Joseph Hospital
* Patient affiliated with a health insurance plan
* French-speaking patient
* Patient who has provided informed, explicit, and voluntary oral consent

Exclusion Criteria:

* Contraindications for an endurance reconditioning program (neurodegenerative diseases, severe neurological deficits, unstable cardiovascular diseases)
* History of motion sickness, vertigo, vestibular impairment, labyrinthitis
* History of seizures or other neurological or psychiatric comorbidities
* Severe visual impairments
* Patient already included in a Type 1 interventional research protocol (RIPH1)
* Patient under guardianship or curatorship
* Patient deprived of liberty
* Patient under legal protection
* Pregnant or breastfeeding patient
Utility of CT Fluoroscopy Guidance During Percutaneous Sacroplasty With Quality of Life Assessment

To examine, through retrospective and prospective chart review, the difference in pain and mobility, pre and post treatment, as assessed by the patient's completion of the VAS pain scale and Roland Morris Disability Questionnaire (RMDQ).

CT fluoroscopy guidance during percutaneous sacroplasty is an effective treatment for sacro-iliac insufficiency fractures resulting in rapid reduction of pain and improved mobility in patients. This can be effectively assessed using the VAS pain scale and RMDQ both pre and post procedure.

The purpose of the study is to report the use of CT fluoroscopy guidance during the performance of percutaneous sacroplasty. In addition, clinical results will be reported with the Roland Morris Disability Questionnaire(RMDQ)pre and post procedure, demonstrating the utility of the RMDQ in assessing improvement in patients pain, mobility and ability to perform activities of daily living.

Eligibility Criteria:
Inclusion Criteria:

* greater than 18 years of age and treated with or about to be treated with percutaneous CT fluoro-guided sacroplasty, regardless of gender or ethnicity.

Exclusion Criteria:

* less than 18 years old
* pregnancy
* inability to complete forms and surveys
Evaluation of the Clinical and Cost-effectiveness of an Automated Mobile Hybrid Room in Vascular Surgery Compared with Current Practice

Evaluation of the clinical and cost-effectiveness of a mobile hybrid room compared with current practice without mobile hybrid room and imaging fusion guidance, in a French multicentre clinical setting.

The hypothesis is that the use of a mobile hybrid room with an automated artificial intelligent image fusion system would directly benefit patients, health worker and health care system by reducing procedure time, patient and staff exposure to radiation, improve clinical success and reduce costs (requested by a fixed imaging system installation and increasing the number of patients). This will also improve the safety of these procedures for patient and staff, when a conventional hybrid room is not available

Multi-centre, patient- and observer-blinded, two-armed, parallel groups randomised controlled trial. 7 French University hospital will include 350 patients presenting with AAA or aorto iliac occlusive disease suitable for endovascular treatment, to either repair using standard X-ray fluoroscopy imaging alone (the current reference standard) or augmented with automated image fusion. The study will be conducted in real-world clinical settings and will focus on multiple providers to demonstrate the effect in the wider healthcare system.

The trial will be conducted in 7 centres in France over 24 months. 350 patients will be recruited over a 18 month period, with 3 months minimum follow-up. Every vascular surgeon will be trained to use properly the fusion system, and the first 5 patients of each center won't be included.

Radiation parameters (machine report, passive dosimeters), iodinated contrast, technical and clinical success at 30-d and 3 months, procedure time, fluoro time, and costs will be collected.

Eligibility Criteria:
Inclusion Criteria:

* Procedure carried out in an operating theatre equipped with a mobile operating theatre C-arm or a mobile planar or an old-generation fixed room with no image fusion available
* Surgeon trained in the use of image fusion
* Operator who has given their consent
* Endovascular management of an aorto-iliac artery disease or a sub-renal AAA using a sub-renal bifurcated stent graft
* Patient in possession of an angioscan less than 6 months old
* Patient of legal age who has given his/her consent
* Ionising radiation generator with up-to-date and validated quality control
* Participant affiliated to a Social Security scheme

Exclusion Criteria:

* First procedure with fusion for the previously trained surgeon.
* Procedure performed without an operating aid.
* Emergency procedure.
* Associated surgical procedure (femoropopliteal lesions, lesions of the renal or digestive arteries, iliac branch).

digestive arteries, iliac branch).

* Patients with AAA that cannot be treated by a simple sub-renal endovascular approach simple endovascular approach (subrenal bifurcated stent graft)
* Aortic emergencies (ruptured AAA).
* Persons under guardianship, curatorship or safeguard of justice
* Pregnant or breast-feeding women.
Exploring HRV in Antarctic Overwintering Members of Asia

Extreme changes in the Antarctic environment can cause emotional and autonomic dysfunction. In this study, volunteers from the Antarctica stations in China provided scale scores and heart rate variability (HRV) data, which were used to assess the autonomic nervous system. Enroll twenty-two members from Zhongshan Station and the Great Wall Station who are overwintering. Using the Generalized Anxiety Disorder (GAD-7) scale, the Patient Health Questionnaire-9 (PHQ-9) scale, and the SF-36 quality of life scale to evaluate the individual's general physical and mental health. Analyze HRV and other associated parameters.

This study was a prospective observational study. We selected 12 members in Antarctica at the Great Wall Station of the 37th Chinese Antarctic Scientific Expedition (CSEA) from March 2021 to April 2022. And 10 members in Antarctica at Zhongshan Station in the 38th CSEA from December 2021 to April 2023. There were 22 members in total. Team members are volunteers selected through interviews, followed by detailed medical and psychological examinations, and are made up of scientific and logistical staff. According to the different work content of the scientific expedition team members, and taking the average outdoor working time of 2 hours/day as the node, the scientific expedition team members are divided into outdoor groups (n=12) and indoor groups (n=10). Participants will be assessed on the day they enter the Antarctic station and leave. Assessments include HRV, SF-36 quality of life questionnaire, Patient Health Questionnaire-9 (PHQ-9) scale and Generalized Anxiety Disorder (GAD-7) scale. This study approved by the local ethics committee of Shanghai Tenth People's Hospital, and conformed to the Declaration of Helsinki and its later amendments.

Eligibility Criteria:
Inclusion Criteria:

* Team members are volunteers selected through interviews, followed by detailed medical and psychological examinations, and are made up of scientific and logistical staff.

Exclusion Criteria:

* People with physical or mental illness
The Effect of Combined Bilateral Infraorbital and Infratrochlear Nerve Block in Nasal Surgeries

The aim of the study is to assess the efficacy of adding a pre-emptive combined bilateral infraorbital and infratrochlear nerve blocks with bupivacaine 0.25% in decreasing intraoperative and postoperative analgesics consumption and maintaining intraoperative hemodynamic stability during nasal surgeries.

Perioperative pain management is one of the most important issues of most surgical procedures. The goal of every pain management technique is to reduce or eliminate pain and discomfort with minimum side effects (Garmella and Cellini, 2012).

Nasal surgical procedures are associated with a high incidence of emergence agitation leading to severe complications such as bleeding and delayed recovery which increase the hospital stay (Kim et al., 2015).

Although the cause of emergence agitation is not well established, Pain in the immediate post-operative period is one of the significant risk factors for emergence agitation. Multiple analgesic interventions are applied to the patient before, during and after surgery prevent these complications (Gray et al., 2018).

The most utilized analgesic interventions are combinations of narcotic and non-steroidal anti-inflammatory drugs. However, they are associated with gastrointestinal and neurological side effects which cause discomfort to the patient and affect surgical recovery profile (Çelik et al., 2018). Therefore, the utility of combining regional nerve block with general anesthesia has been popularized in clinical practice to provide improved perioperative analgesia, decreased narcotic consumption and enhanced emergence and recovery characteristics (Mariano et al., 2009; Ibrahim et al., 2018).

The infraorbital nerve (ION) is a branch of the maxillary part of the trigeminal nerve. This nerve innervates the skin of the nose and septum mobile nasi. The infratrochlear nerve (ITN) innervates the root of the nose and is an extraconal branch of the nasociliary nerve, which is a branch of the ophthalmic portion of the trigeminal nerve (Choi et al., 2019).

Although these nerve blocks are simple and easy to use with few complications, there are limited reports that suggest combined bilateral infraorbital and infratrochlear nerve blocks to be effective to facilitate pain management and reduce anesthetic agent consumption and perioperative dose of narcotics in nasal procedures (Cekic et al., 2013; Boselli et al., 2016).

Eligibility Criteria:
Inclusion Criteria:

1. Age group: 18 - 55 years old.
2. American Society of Anesthesiologists (ASA) Physical Status Class I or II
3. Scheduled for elective nasal surgery under general anesthesia.

Exclusion Criteria:

1. Refusing to participate in the study or inability to provide informed consent.
2. History of allergy to the medications used in the study.
3. Contraindications to regional anesthesia (including coagulopathy, INR ≥ 1.4 and local infection).
4. Compromised renal or liver functions.
5. History of substance or alcohol abuse.
6. Pre-existing chronic pain of different etiology.
7. Psychiatric disorders.
8. Pregnancy.
Responsiveness of Outcome Scales in Breast Cancer Related Lymphedema

The aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish.

Lymphedema is defined as the excessive and persistent accumulation of fluid, extracellular proteins, and fat in tissue spaces, caused by inefficiency of the lymphatic drainage system. It is a chronic, progressive condition. Several researchers have investigated the influence on health-related quality of life in upper limb lymphedema after breast cancer treatment using patient reported outcome instruments. Responsiveness of only one of the lymphedema assessment scale, ''Lymphedema Quality of Life Inventory'', has been investigated. Responsiveness of lymphedema assessment scales validated in Turkish has not been examined in detail, thereby limiting their use in clinical trials. Therefore, the aim of this study is to investigate and compare responsiveness of current lymphedema assessment scales validated in Turkish. Patients with breast cancer related lymphedema with International Society of Lymphology-ISL lymphedema stage 2,3 will be included in the study and will receive complex decongestive therapy phase I including meticulous skin and nail care, manuel lymphatic drainage, compression bandages, and remedial exercises. All patients will receive manual lymphatic drainage for three times a week (Monday-Wednesday-Friday) during 4 weeks, 50 minutes a day (a total of 12 sessions) by a trained lymphatic massage therapist. Limb volume will be calculated based on truncated cone method from circumference measurements. Patients will complete Lymphedema Life Impact Scale (LLIS), Patient Benefit Index-Lymphedema(PBI), Lymphedema functioning, disability and health questionnaire(Lymph-ICF), European Organization for Research and Treatment of Cancer Quality of Life Breast Cancer (EORTC-QLQ-30) and Short Form 36 (SF-36) before and after treatment. Changes in limb volumes will be compared in changes in scales after treatment. Responsiveness of the subscales will be will be determined by calculating the effect size (change in all patients), standardized mean response (effect size in a group with improvement), and Guyatt's Responsiveness Index.

Eligibility Criteria:
Inclusion Criteria:

-Patients with unilateral postmastectomy lymphedema with a International Society of Lymphology-ISL) stage 2 and 3

Exclusion Criteria:

* Bilateral lymphedema
* The patients who had known systemic edematogenic conditions (e.g., cardiac/hepatic/renal failure, terminal cancer, on chemotherapy), and/or with cancer recurrence
* Patients with contraindications for application of complex decongestive therapy (active cutaneous infection, deep vein thrombosis, cardiac edema, and peripheral artery disease)
Dose-effect Relationship of Rt-PA on ICH Evacuation

The purpose of this trial is to determine the optimal dose of rt-PA in the treatment of intracerebral hemorrhage (ICH) using a combination of minimally invasive surgery and clot lysis with rt-PA。

The minimally invasive surgery (MIS) plus recombinant tissue plasminogen activator (rt-PA) is one of the best choices in the treatment of a large-scale deep supratentorial intracerebral hematoma. It uses hardware access technology, in a relatively short time to enter the hematoma center with favourable accuracy and safety.

The dose of rt-PA range from 0.3 mg to 4.0 mg in different research。We propose to determine the optimal dose of rt-PA with three dose control groups.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80.
* GCS \< 14 or a NIHSS \> or equal to 6.
* Spontaneous supratentorial ICH ≥ 20 mL diagnosed using radiographic imaging (CT, CTA, etc.)
* Symptoms less than 24 hours prior to diagnostic CT(dCT) scan (an unknown time of symptom onset is exclusionary).
* Six-hour clot size equal to the most previous clot size (within 5 mL) as determined by additional CT scans at least 6 hours apart using the ABC/2 method.
* Intention to initiate surgery between 12 and 72 hours after after diagnostic CT. First dose can be given within 76 hours after dCT (delays for post surgical stabilization of catheter bleeding).
* SBP \< 180 mmHg sustained for 6 hours recorded closest to time of randomization.
* Historical Rankin score of 0 or 1.
* Negative pregnancy test.

Exclusion Criteria:

* Infratentorial hemorrhage (any involvement of the midbrain or lower brainstem as demonstrated by radiograph or complete third nerve palsy).
* Irreversible impaired brain stem function (bilateral fixed, dilated pupils and extensor motor posturing), GCS ≤ 4.
* Intraventricular hemorrhage requiring treatment with extraventricular drainage (obstruction of third and fourth ventricles).
* Ruptured aneurysm, arteriovenous malformation (AVM), vascular anomaly, Moyamoya disease diagnosed with radiographic imaging.
* Any irreversible coagulopathy or known clotting disorder. or having the experience of the use of anticoagulant drug.
* Platelet count \< 100,000, INR \> 1.7, or an elevated prothrombin time (PT) or activated partial thromboplastin time (aPTT).
* Positive urine or serum pregnancy test in pre-menopausal female subjects without a documented history of surgical sterilization.
* Any concurrent serious illness that would interfere with the safety assessments including hepatic, renal, gastroenterologic, respiratory, cardiovascular, endocrinologic, immunologic, and hematologic disease.
* Historical Rankin score greater than or equal to 2.
Ten-year Practice of Labor Pain Control in China

Since 1999, labor pain control has being performed in China, and the initial time of analgesia is at the cervix \>= 2 cm. Meanwhile, American Society of Obstetrics \& Gynecology recommended that the labor analgesia with neuraxial block should be performed at the cervix \>= 4 cm in 2002. After that, the threshold has been revised to at least \>= 2 cm in 2006 by the Society. However, in China, the practice of labor analgesia with neuraxial block has being performed for over seven years. Up until now, the practice has being experienced during this ten-year period at the cervix around 1 cm. The investigators hypothesized that labor pain control in different stages had different characteristics and had different influence on patients short- and long-lasting outcomes. This study is mainly investigating different labor analgesia procedures in different stages since the initiation of the practice in 1999, and assessing their influence on the outcomes to display the trajectory of development of labor analgesia in China of which might fit to the the whole process of the study of labor analgesia throughout the world. All these were done by analyzing the data records since from January 1999 to December 2008.


Eligibility Criteria:
Inclusion Criteria:

* Parturients used labor analgesia

Exclusion Criteria:

* Following criteria were based on the records of information received from the ten-year practice screened by investigators:

  1. Chronic pain and psychiatric diseases records
  2. Participants younger than 18 years or older than 45 years
  3. Alcohol addictive or narcotic dependent patients were excluded for their influence on the analgesic efficacy of the epidural analgesics
  4. Subjects with a nonvertex presentation or scheduled induction of labor
  5. Diagnosed diabetes mellitus and pregnancy-induced hypertension
  6. Twin gestation and breech presentation
Lawrence Latino Diabetes Prevention Project

The Lawrence Latino Diabetes Prevention Project (LLDPP) is a community-based translational research study which aims to reduce the risk of diabetes among Latinos who have a \>30% probability of developing diabetes in the next 7.5 years per a predictive equation. The project was conducted in Lawrence, Massachusetts; a predominantly Caribbean-origin urban Latino community. Individuals were identified primarily from a community health center's patient panel, screened for study eligibility, randomized to either a usual care or a lifestyle intervention condition, and followed for one year.

The group format of the intervention included 13 group sessions complemented by 3 individual home contacts over one year and was implemented by individuals from the community with training and supervision by a clinical research nutritionist and a behavioral psychologist. Study measures included demographics, Stern predictive equation components (age, gender, ethnicity, fasting glucose, systolic blood pressure, HDL-cholesterol, body mass index, and family history of diabetes), glycosylated hemoglobin, dietary intake, physical activity, depressive symptoms, social support, and quality of life. Body weight was measured at baseline, 6-months, and one-year; all other measures were assessed at baseline and one-year. All surveys were orally administered in Spanish.

Eligibility Criteria:
Inclusion Criteria:

* Is Latino/Hispanic;
* Has a 7.5 year likelihood of becoming diabetic of greater than or equal to 30% as predicted by the Stern formula;
* Is greater than or equal to 25 years of age;
* Has a BMI greater than or equal to 24 kg m2.

Exclusion Criteria:

* An inability or unwillingness to give informed consent;
* Has clinically diagnosed diabetes, or a fasting blood sugar of greater than or equal to 126 mg/dl;
* Plans to move out of the area within the study period;
* Has a psychiatric illness which limits ability to participate;
* Has no telephone;
* Is unable to walk unaided, or cannot walk five city blocks (1/4 mile) without stopping;
* Is not cleared for the PA component by the pt's GLFHC primary care provider;
* Has a medical conditions likely to limit lifespan;
* Is on medications or has a medical condition that interfere with the assessment for diabetes.
Systematically Assessing Effects of Colored Light on Humans With a Multi-modal Approach (Substudy 5 of 7)

NOTE: This is the fifth of in total 7 sub-studies related to the Ethics Committee of the Canton of Bern Ref. No. KEK-BE 2016-00674. This sub-study includes 50 participants and 8 arms, in total 350 participants will be assessed in all 7 sub-studies.

General study information: This is a randomized, cross-over, quantitative study, which investigates physiological variables, mood, and affect of healthy participants in response to colored light exposure. The Participants take part in 5-8 arms and are exposed to colored light only, or are additionally asked to solve cognitive tasks during the colored light exposure. Primary aim is to measure the change in several physiological variables, mood, and affect during colored light exposure of 15 or 45 minutes. The risk for the participants is negligible and comparable to the risk during daily life.


Eligibility Criteria:
Inclusion Criteria:

* Normal color vision
* Right handed
* Written informed consent

Exclusion Criteria:

* Smoking
* Any kind of diagnosed sleep disorder or neurological or psychiatric disorder in the last 3 months
* Acute severe traumas
* Chronic diseases with the necessity for medication
* Use of recreational drugs
* Regular intake of medication that would affect the outcome measures
* Regular excessive alcohol use (\> 18 standard units / week)
* Transmeridian travel in the last month (crossed \> 1 time zone border)
* Night shift word during the last month