cyrilzakka/clinical-trials huggingface dataset:
Breathing Room Intervention to Achieve Better Lung Health in Older Adults

This proposed study will evaluate whether a novel nonpharmacological intervention, Breathing Room, can improve lung function in the target population of older adults. Therefore, the primary aim of this pilot is to examine the effect of Breathing Room on inspiratory muscle strength, spirometry confirmed ventilatory function (Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and FEV1/FVC), functional status, posture, physical activity, and lower respiratory infection rates.

Restrictive ventilatory patterns (RVPs) contribute to two prevalent problems in older adults: 1) the development of pneumonia and other lower respiratory infections; and 2) declining endurance for physical activity. The Breathing Room was developed as an exercise activity designed to open the thoracic cage, increase strength of the muscles of respiration with inspiratory muscle trainers, and optimize the breathing technique.

This will be a pretest-posttest design in which the outcomes are measured at baseline, and at two weeks and four weeks post start of Breathing Room intervention. Breathing Room classes will be held 3 times a week for 4 weeks (2 group classes, 1 individual reinforcement of Inspiratory Muscle Training \[IMT\] homework). The IMT homework includes 3 days 5 cycles of 5 breaths, each cycle followed by 2-minute rest. The IMT will be also utilized during the 2 group classes.

The group classes will be conducted with a maximum of 5 participants in each group. Data on inspiratory muscle strength, spirometry confirmed ventilatory function (Forced Expiratory Volume in one second (FEV1), Forced Vital Capacity (FVC) and FEV1/FVC), functional status, posture, and physical activity will be collected. Infection rate data for each resident for 4 months following completion of Breathing Room will be also collected.

Eligibility Criteria:
Inclusion Criteria:

* able to understand English
* baseline oxygen saturation level is above 85%
* spirometry-confirmed restrictive ventilatory pattern (forced vital capacity \< 80% predicted, forced expiratory volume in 1 second/forced vital capacity ≥ 0.70

Exclusion Criteria:

* have lung disease classified as restrictive or obstructive
* have unstable angina/myocardial infarction, eye or lung surgery within the previous 8 weeks or aneurysm
* have had major orthopedic surgery in the last 12 weeks
* have been told they have heart failure, take a diuretic "water pill" and have been told to restrict their salt and fluid intake (symptoms that coincide with Stage C of heart failure based on the American College of Cardiology and the American Heart Association classification system
* score in the severely impaired range on the Short Orientation Memory Concentration Test
* history of spontaneous pneumothorax
Analytic and Functional Evaluation After Surgical Treatment Using an Original Arthroscopic Trillat Technique in Patients With Chronic Anterior Shoulder Instability

The shoulder is the most mobile joint in the body, and the most exposed to the risk of dislocation notably anterior. Chronic instability of the shoulder is frequent after dislocation, and principally affects people who are young and active. It can have major functional repercussions, leading to restricted participation in professional or sports activities, even in everyday life activities.

Surgical stabilisation is the reference treatment for chronic anterior shoulder instability, and has given good results. There are numerous surgical techniques available; the orthopaedists at Dijon CHU now practice the Bristow-Trillat technique under arthroscopy, following many years of reflexion and adaptation.

Rehabilitation following the surgery is essential, notably to recover muscle strength in the shoulder rotator cuff after surgery, which correlates directly with dynamic stability of the joint. At the moment, we do not know the objective evolution of muscle strength after the Trillat arthroscopic technique.

The isokinetic evaluation of muscle strength in the rotator cuff has been validated and is reproducible. It gives objective and reliable values for muscle strength, thus making it possible to guide and to optimise rehabilitation protocols done by patients under the supervision of a physiotherapist, and to estimate time to the return to physical, professional or sports activities, without risk.


Eligibility Criteria:
Inclusion Criteria:

* Persons informed about the research
* Male or female
* Age between 16 and 45 years
* Regular sport activity (leisure or competition)
* First surgical indication for stabilisation using the Trillat arthroscopic technique
* Patient operated on using the Trillat arthroscopic technique for chronic anterior shoulder instability in the orthopaedic and trauma unit of Dijon CHU

Exclusion Criteria:

* Persons without health insurance cover
* Concomitant, disabling shoulder joint disease inflammatory rheumatism, which could be exacerbated by the tests
* Associated lesions in the shoulder: rupture of rotator cuff tendons, neurological lesions, bone lesions: fracture of the neck of humerus, of the greater tubercle or the coracoid process
* Paraplegia and peripheral neurological disease
* Surgery other than the Trillat arthroscopic technique alone
* Treatment with the Trillat arthroscopic technique as second line, after failure of the first strategy
* Contralateral history of dislocation with surgical repair
* History of disease with excess laxity (collagen disease, Marfan, Elhers-Danlos)
* History of debilitating pain in the back, elbows or wrists
* Contra-indication for isokinetic tests
* Cognitive disorders
* Major post-operative complications delaying the rehabilitation
* Early recurrence of dislocation after surgery
* Post-operative immobilisation protocol not respected
Awake Nasal Fiber-optic Intubation of Severely Obese Patients in Lateral Position

Airway management in severely obese patients remains a challenging issue for anesthetists and may lead to life-threatening situations. Awake Fiber-Optic Bronchoscopy Intubation (FOBI) technique is considered as the gold standard when a difficult airway is anticipated to secure the airway and to facilitate the surgery. FOBI is usually done in supine position, while (in conscious patients) lateral position is the most recommended position to keep the upper airway patent. This prospective clinical trial study will test whether awake FOBI in Lateral position will provide a safe profile or a significant advantage over FOBI in supine position, in morbidly obese patients undergoing elective bariatric surgery.

Airway management in severely obese patients remains a challenging issue for anesthetists and may lead to life-threatening situations. Awake Fiber-Optic Bronchoscopy Intubation (FOBI) technique is considered as the gold standard when a difficult airway is anticipated to secure the airway and to facilitate the surgery. FOBI is usually done in supine position, while (in conscious patients) lateral position is the most recommended position to keep the upper airway patent.

This prospective clinical trial study will test whether awake FOBI in Lateral position will provide a safe profile or a significant advantage over FOBI in supine position, in morbidly obese patients undergoing elective bariatric surgery. The main outcome is success rate and duration of the procedure. Secondary outcomes are oxygenation maintenance, hemodynamic stability, airway complication, sedation score, and postoperative airway morbidity in 6 hours after surgery.

Eligibility Criteria:
Inclusion Criteria:

* American Society of Anesthesiologists physical status classification two and three.
* Patients scheduled for elective bariatric surgeries under general anesthesia.

Exclusion Criteria:

* Refusal of fiberoptic intubation.
* Allergy to local anesthetics.
* Coagulopathy.
* Raised intracranial or intraocular pressure.
Muscle Response to High Intensity Interval Resistance Training (HIIRT)

Resistance training (RT) is one of the most important stimuli for muscle hypertrophy and it plays an important role on weight loss and fatty acid oxidation increase. RT affects anabolic pathways but the differences among various training techniques has been till now were poorly investigated. The aim of this study was to compare the effect of two different intensity of training, high-intensity interval resistance training (HIIRT) and traditional resistance training (TRT), on muscle signalling pathway.

Nine young healthy subjects performed HIIRT and TRT protocol in two different moments and with different legs. HIIRT technique consisted of three sets of: 6 repetitions at 6RM (6 repetitions maximum) and then 20 seconds of rest and 2/3 repetitions (until exhaustion) repeated for 3 times with 2'30" rest between sets; while TRT consisted of 3 sets of 15 reps with 75 sec of rest between sets. Biopsies from the vastus lateralis were taken at baseline (pre), immediately (0h) at the end of training, 6 hours (6h) and 24 hours (24h) after training. Western blot and RT-PCR mRNA (Reverse transcriptase-polymerase chain reaction) analysis were performed to assess muscle signalling pathway activation

Eligibility Criteria:
Inclusion Criteria:

* moderate active
* experience with resistance training

Exclusion Criteria:

* history of recent myocardial infarction,
* severe cardiac arrhythmia,
* unstable angina,
* poorly controlled hypertension,
* poorly controlled diabetes mellitus,
* frequent or complex ventricular ectopy which might interfere with one's ability to adhere to exercise protocols
The Effect of Simulation Method on Self-Confidence and Stress Levels in Nursing Students

The aim of this study was to determine the impact of training provided through simulation method on self-confidence and stress levels in nursing students during patient intervention.

Improving nursing students' clinical skills and enhancing their professional competencies by increasing their patient intervention skills and strengthening their ability to cope with stress is crucial. High professional confidence among nursing students is fundamental to providing effective patient care, which is critical for patient safety and satisfaction. Simulation training is an effective tool used to enhance nursing students' practical experiences in clinical settings. This method provides students with the opportunity to encounter real-life scenarios in a controlled environment and intervene in these situations. Additionally, simulation training can help develop coping skills for dealing with stress, as it prepares students for situations they may encounter in real clinical settings. The aim of this study is to determine the impact of training provided through simulation method on self-confidence and stress levels in nursing students during patient intervention.

The students included in the study will be divided into experimental and control groups through full randomization. The Student Identification Form will be administered to both groups initially. The theoretical part of Shock Nursing Care (SNC) training will be provided to the control group through in-class face-to-face education. Following the theoretical training, skills training will be conducted in the nursing skills laboratory using the demonstration method. Students will be evaluated using the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale before and after the training. The study group will receive theoretical education similarly to the control group through in-class face-to-face education. Following the theoretical education, simulation training will be conducted in the Simulation Laboratory based on the SNC Scenario. Simulation training will be conducted in groups of 10, consisting of 5 students each. Each student will be provided the SNC scenario to practice. Students will be evaluated using the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale before and after the training. The mean scores of both groups on the Self-Confidence/Competence in Patient Intervention Scale and the Perceived Stress Scale will be compared both between and within groups. Pre-graduation nursing simulation education will contribute to enhancing students' patient intervention skills and stress coping abilities.

Eligibility Criteria:
Inclusion Criteria:

* Volunteering to participate in the research, being a senior nursing student

Exclusion Criteria:

* Not participating in any simulation training
Rim Plate to Buttress Plate for Posterior Wall Acetabular Fractures With and Without Inter-fragmentary Screws

The hypothesis of this study is that the Rim Plate method utilizing interfragmentary screws placed through the plate will result in superior fixation, a lower rate of loss of reduction of the fracture fragment, better anatomic healing of the articular (joint) surface, a decreased rate of early post-traumatic arthritic changes of the joint (cartilage) surface, and improved functional outcomes.

Study type: Interventional Estimated enrollment: 60 Allocation: block randomization. The block randomization method is designed to randomize subjects into groups that result in equal sample sizes. This method is used to ensure a balance in sample size across groups over time.

Interventional model: parallel assignment Description: two different methods of screw and plate fixation of posterior wall acetabulum fractures.

Time perspective: Prospective

Population:

Skeletally mature patients who have presented with an acute traumatic fracture of the posterior wall of acetabulum due to dislocation of the femoral head will be included in this study. All surgeons on the study routinely perform both types of repairs.

Treatment arms and Intervention:

Arm A: Rim plate group - This group will consist of 30 patients where the posterior wall fracture will be operatively stabilized with a pelvic reconstruction plate and interfragmentary screws placed through the plate.

Arm B: Buttress plate group - This group will consist of 30 patients where the posterior wall fracture will be operatively fixed with a buttress plate applied under compression without interfragmentary lag or position screws.

Eligibility Criteria:
Inclusion Criteria:

1. Skeletally mature males and females, ≥ 18 years old and with age less than 65 years.
2. Fracture of the acetabular posterior wall fracture due to acute traumatic hip dislocation, confirmed with anteroposterior pelvic or hip radiographs, and CT scan
3. Operative fixation of fractures within 14 days of presenting to the emergency room.
4. Patient was ambulatory prior to fracture, with or without walking aids
5. Medically optimized for operative intervention
6. Provision of informed consent by patient or legal guardian.

Exclusion Criteria:

1. Patients not suitable for internal fixation (severe osteoarthritis, rheumatoid arthritis, or pathologic fracture).
2. Pre-existing orthopedic fixation, implant, or prosthesis around the affected acetabulum.
3. Patients with metabolic bone disease including diagnosis of osteoporosis.
4. Patients with bony or soft tissue infections around the acetabulum.
5. Patients unable to provide informed consent.
6. Patients having other fractures of Pelvis or acetabulum other than an isolated posterior acetabular wall fracture.
7. Patients with previous history of acetabular fracture (operative or nonoperative)
8. Patients with previous history of hip pathology such as avascular necrosis, hip dysplasia, Legg-Calve Perthes Disease, or advanced degenerative arthritis.
Analysis of the Results of Treatment for Cervical Carcinoma in Limburg

Analysis of all women treated for cervical cancer between 2000 and 2008 in Limburg, a province in the south of the Netherlands. Patient characteristics, diagnosis, treatment modalities, complications and survival will be analyzed by record review. Quality of life of the living study population will be assessed using the EORTC QLQ-C30 and QOQ-CX24 questionnaire. Patients will be identified via registration data from the Integraal Kankercentrum Limburg.


Eligibility Criteria:
Inclusion Criteria:

* cervical cancer FIGO stage IB-1 to IVB
* Treated in Limburg between 2000 and 2008

Exclusion Criteria:

* none
Body Weight Support in Spinal Cord Injury

The purpose of this study was to evaluate the effectiveness of body weight-supported treadmill (BWST) training on static balance impairment in adults with incomplete spinal cord injury (SCI) in chronic stage

The individuals who participated in this study were subjects with SCI with more than twelve months of evolution. All were classified as incomplete injury class C or D according to the American Spinal Injury Association (ASIA). Each received training on a BWST for six weeks. Two measures of stance balance were performed during the training protocol. The first measure was made before entering the training protocol; the final measure was implemented once the gait training on BWST protocol was completed. For instrumented stance balance testing, small wireless inertial motion sensors (OPAL sensors, APDM Inc., Portland, OR) were placed on the subjects' waist. Subjects performed instrumented stance with their eyes opened (iSway). Outcome measures were recorded and automatically generated using Mobility Lab software (APDM Inc., Portland, OR). Measures included the root mean square of sway and jerk (normalized to the range of acceleration amplitude).

Eligibility Criteria:
Inclusion Criteria:

* SCI with more than twelve months of evolution.
* ASIA C and D

Exclusion Criteria:

* Patients with tracheostomy
* Patients with severe respiratory, cognitive and cardiovascular comorbidities
* Patients with peripheral nerve injury in lower limbs
* Patients with traumatic head injury
Safety, Tolerability and Efficacy of Indacaterol in Patients With Moderate-to-severe Chronic Obstructive Pulmonary Disease (COPD)

This study evaluated the 1 year safety, tolerability and efficacy of indacaterol against placebo in the treatment of Chronic Obstructive Pulmonary Disease (COPD) patients


Eligibility Criteria:
Inclusion Criteria:

* Patients eligible to participate in the study extension, by definition, will have met the inclusion and exclusion criteria for the core 26 weeks and not met the withdrawal criteria for the core study B2335S at Visit 14 (the last visit of the core study B2335S and the first visit of the extension study B2335SE).
* In addition the following inclusion/exclusion criteria specified below must be met.

  1. Patients must complete Stage 2 of the core study B2335S (NCT00463567).
  2. Written informed consent to participate in the extension must be obtained.
  3. Patients must be able to comply with all study requirements.

Exclusion Criteria:

* Patients who were randomized to open-label tiotropium in Study B2335S.
* Patients who participated in Stage 1 of the core study (B2335S).
* Patients discontinued irrespective of the reason from Stage 2 of the core study.
* Patients who fail to comply with the core protocol requirements and procedures.
* Concomitant medical conditions that may interfere with interpretation of study results as defined in the core study protocol.
* Patients who in the Investigator's opinion should not participate in the extension study.

Other protocol-defined inclusion/exclusion criteria may apply
Study to Continue Treatment With Darolutamide in Patients Who Have Been Participating in Previous Darolutamide Studies Supported by Bayer

The aim of this study is to provide darolutamide treatment to patients who participated in a previous study with darolutamide supported by Bayer and the treating doctor considers that the continuation of the treatment with darolutamide to be beneficial. Patients will be carried over from the previous studies and continue in this study with darolutamide treatment on the same dosage. They will also return to the study centers for doctor's visits as often as they did in the previous study.


Eligibility Criteria:
Inclusion Criteria:

* Capable of giving signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol.
* Participants enrolled in any Bayer-sponsored darolutamide feeder study at the time of study closure or primary completion, who are currently receiving darolutamide and are experiencing clinical benefit from treatment.
* Participants who have not met any treatment discontinuation criteria in the feeder study protocol.
* Willingness to continue practicing acceptable methods of birth control during the study.

Exclusion Criteria:

* Participant is unable to comply with the requirements of the study.
* Negative benefit/ risk ratio as determined by the investigator.
* Meet any criteria for treatment discontinuation of the feeder study the participant is coming from.
Ventricular Sling for Heart Failure With Reduced Ejection Fraction

The purpose of this research is to investigate the effect of using this surgical technique in conjunction with bypass surgery to improve heart function and size, as well as decrease the possibility of future mitral valve surgery.

The Sling is used to draw together the ventricular walls at the base of the papillary muscles. This technique has previously been used in conjunction with mitral valve surgery, and has shown significant benefits for the patients.

The reduction in the lateral inter-papillary muscle separation and in the left ventricular volume provided by this technique is expected to improve ventricular function, limit progression of ventricular dilation, and avoid progression of MR when performed without mitral valve surgery in patients with symptomatic ventricular dilation.

Eligibility Criteria:
Inclusion Criteria:

Patients with symptomatic heart failure with reduced ejection fraction and either ischemic or non-ischemic cardiomyopathies, referred for CABG surgery. Suitability for the ventricular sling procedure is determined by the surgeon and or cardiologist, using some or all the criteria described below:

* Left ventricular end diastolic diameter is greater than or equal to 55mm.
* Ejection fraction ≥20% and ≤40%
* FMR grade ≤ 2+ (≤ mild FMR) as defined by the guidelines of the American society of echocardiography at the time of the study approval (via a transthoracic or transesophageal echo).
* End-systolic Interpapillary muscle distance ≥ 20mm
* Cardiomyopathy of ischemic or non-ischemic origins.
* Able to sign informed consent and release of medical information forms, or able to assign a legal representative who can sign on the patient's behalf.

Exclusion Criteria:

* Any evidence of structural (chordal or leaflet) mitral lesions.
* Planned concomitant intra-operative procedures (except for closure of patent foramen ovale or atrial septal defect or coronary revascularization)
* Planned concomitant intra-operative Maze procedure for symptomatic paroxysmal atrial fibrillation.
* Persistent atrial fibrillation
* Prior mitral valve repair
* Contraindication for cardiopulmonary bypass
* Clinical signs of cardiogenic shock
* ST segment elevation myocardial infarction within 14 days prior to inclusion in this study.
* Congenital heart disease (except PFO or ASD)
* Chronic renal insufficiency defined by Creatinine ≥ 3.0 or chronic renal replacement therapy, who are contraindicated for cardiac surgery
* Recent history of psychiatric disease that is likely to impair compliance with the study protocol, in the judgement of the investigator
* Pregnancy