cyrilzakka/clinical-trials huggingface dataset:
Long-term Outcome After Isolated Tricuspid Valve Repair

Tricuspid valve insufficiency (TI) is often noted on echocardiography. Although severe TI is known to cause significant morbidity and mortality, no good guidelines are available to guide intervention. Literature is mostly confined to tricuspid valve repair concomitant with mitral valve repair. Treatment options for isolated repair have not been investigated thoroughly.

The investigators want to evaluate retrospectively the outcome of isolated tricuspid valve repair, performed in our center. By doing this, the investigators want to evaluate predictors of outcome after repair.


Eligibility Criteria:
Inclusion Criteria:

* tricuspid valve insufficiency

Exclusion Criteria:

* younger than 18 years
* associated valvular surgery
Effect Of Digital Smile Design on Quality Of Life In Complete Denture Wearers

The aim of the current study protocol is to compare the effect of two complete dentures made for completely edentulous patients; one digitally constructed using digital smile design (DSD) and another one conventionally constructed on the patient's quality of life and patient's satisfaction.

It is a clinical trial in which two dentures will be made for each patient, one will be digitally constructed using digital smile design (DSD) and the other one using the conventional method with a washout period of 3 weeks. Each patient will receive a questionnaire "Oral Health Impact Profile -19" (OHIP -19) for the edentulous patients to evaluate his satisfaction with the denture.

Although the aesthetic results of digitally constructed dentures might be satisfactory for the patients, there is still little clinical evidence for the effect of using digital smile design DSD in denture construction on the patient's satisfaction. So, the objective of the current study is to find the effect of digital smile design (DSD) on quality of life in complete denture wearers compared to the conventionally created one. The current study is planned to be a crossover randomized Controlled Trial (RCT). The principal investigator, participants and the statistician will be blinded. Simple randomization of the patients in the will take place using a computer generated list (Software informer, Informer Technologies Inc) and allocated into two groups; a conventional denture followed by a digital group (CG) and a digital denture followed by a conventional one group (DG). Parallel allocation in ratio 1:1 will take place. The names of the participants in both groups will be placed in closed opaque sealed envelopes according to the computer generated list of random numbers and an envelope will be allocated to each patient. For blinding and allocation concealment, a third party rather than the authors and participants will be the only one to know the key so that the authors and the participants won't know in which group the participant will be. Afterwards, the authors will be informed by the randomization to be tabulated.

Eligibility Criteria:
Inclusion Criteria:

* completely edentulous patients
* well formed edentulous ridge
* healthy, pink, non edematous mucosa of even thickness

Exclusion Criteria:

* heavy smokers
* patients with parafunctional habits, temporomandibular joint disorders or orofacial motor disorders
* patients with physicological or psychiatric condition
Clinical Trials for Comparison of Two Kinds of Moxibustion

The purpose of this study is to evaluate efficacy of Shingigu and Charcoal moxibustion scientifically and objectively.

Moxibustion is traditional treatment that regulate circulation of Qi-blood by making the body warm to prevent and treat disease. Recently many kinds of moxibustion and moxibustion apparatus were developed. However evaluating efficacy of moxibustion is insufficient. Thus, there is need for objective evaluating about efficacy of moxibustion.

Eligibility Criteria:
Inclusion Criteria:

* 18\~65 years old

Exclusion Criteria:

* Hyperthyroidism
* Heart disease(Heart failure, angina pectoris, myocardial infarction)
* Uncontrolled hypertension (SBP\>145mmHg or DBP\>95mmHg)
* Severe renal disorder
* Severe liver disorder
* Diabetes Mellitus
* Female are in the duration of pregnancy
A Study to Determine the Efficacy and Safety of Finerenone and SGLT2i in Combination in Hospitalized Patients with Heart Failure (CONFIRMATION-HF)

Combination therapy of finerenone plus empagliflozin will be compared to usual care to determine the efficacy and safety of treatment in patients hospitalized with heart failure.

This is an international, randomized, controlled, open-label, trial of an early, intensive management strategy using the combination of finerenone plus sodium-glucose co-transporter 2 inhibitor (SGLT2i) compared with usual care in patients hospitalized with heart failure (HF).

Eligibility Criteria:
Inclusion Criteria:

* Provide electronic or written informed consent, either personally or through a legally authorized representative, as permitted by local regulations
* Age ≥18 years or legal age of majority if \>18 years in the participant's country of residence
* Current hospitalization or recently discharged with the primary diagnosis of heart failure
* Heart failure signs and symptoms at the time of hospital admission
* Elevated N-terminal pro B-type natriuretic peptide (NTproBNP) ≥500 pg/mL or B-type natriuretic peptide (BNP) ≥125 pg/mL according to the local lab for patients in sinus rhythm; or elevated NTproBNP ≥1500 pg/mL or BNP ≥375 pg/mL for patients with atrial fibrillation (AF), measured during the current hospitalization or in the 72 hours prior to hospital admission
* Fulfillment of protocol defined stabilization criteria (if randomized during hospitalization)
* Treatment during the index hospitalization with at least 1 intravenous dose of a loop diuretic (e.g., furosemide, torsemide, bumetanide).
* Negative pregnancy test and agreement to use adequate contraception during trial (female participants only)

Exclusion Criteria:

* Diagnosis of type 1 diabetes or prior history of diabetic ketoacidosis
* Documented prior history of severe hyperkalemia in the setting of MRA use
* Treatment with non-steroidal mineralocorticoid receptor antagonist (MRA) or SGLT2i
* Estimated glomerular filtration rate (eGFR) \<30 mL/min/1.73m² and/or potassium \>5.0 mmol/L
* Acute myocardial infarction, coronary revascularization, valve replacement/repair, or implantation of a cardiac resynchronization therapy device within 30 days
* Prior or planned heart transplant
* Hemodynamically significant uncorrected primary cardiac valvular disease as primary cause of heart failure
* Cardiomyopathy due to acute inflammatory heart disease, infiltrative diseases, accumulation diseases, muscular dystrophies, cardiomyopathy with reversible causes, known hypertrophic obstructive cardiomyopathy, complex congenital heart disease, or pericardial constriction
* Probable alternative cause of participant's heart failure symptoms
* Concomitant systemic therapy with potent cytochrome P450 isoenzyme 3A4 (CYP3A4) inhibitors or moderate CYP3A4 inducers, or potent CYP3A4 inducers
* Known hypersensitivity to the IP (active substance or excipients)
* Any other condition or therapy which would make the patient unsuitable for this study
LifeCourse: A Supportive Care Approach for Patients Late in Life

The purpose of the study is to test a new model of care for patients with an ongoing or significant medical condition.

LifeCourse is a late life care approach that promotes whole person care through a structured approach built upon an expanded set of palliative care domains and chronic illness care practices. It includes a trained lay healthcare worker as the primary contact who follows the patient across care settings and over time. The care guide asks patients and caregivers to articulate individualized goals and take part in decision making, and uses a family-oriented approach to understand needs, leverage strengths, and empower families to effectively support the individual living with serious illness.

Eligibility Criteria:
Inclusion criteria

* Patient has an Allina Health primary or specialty provider
* Patient's medical chart indicates an on-going or significant medical condition
* LifeCourse will invite vulnerable patients to enroll, including:
* Critically ill patients
* Cognitively impaired patients
* Elderly patients, some of whom may have cognitive impairment and/or be institutionalized

Exclusion Criteria

* Patient resides in a zip code which does not lie partially within a 45 mile radius from the Allina Health Commons in Minneapolis, Minnesota.
* Patient has not visited an Allina facility, affiliate, or community partner within the last year.
* Patient is eligible for hospice.
* Patient is actively dying.
* Patient is abusive or is discharged against medical advice (AMA).
Intraoperative ADSC Administration During Nerve Release

The goal of the investigator's observational, nonrandomized, open label study is to investigate the safety and efficacy of autologous adipose derived mesenchymal cells (ADSC) transplantation into the individuals with faiure in reconstruction of peripheral nerves. ADSC will be used during a last-chance surgery (neurolysis, nerve release) on a previously reconstructed nerve. All enrolled patients will have a documented at least 2-years clinical and electrophisiological observation. Each patient will recive once 10 microinjections of ADSC along the injured nerve, directly after nerve neurolysis. Safety, adverse events and efficacy will be confirmed by clinical, elecrophisiological (EMG, Sensory Thyreshold) and DASH survey.

The aim of the study will be an evaluation of undifferentiated Adipose-Derived Stromal/Stem Cells (ADSC) usage during a last-chance surgery (neurolysis, nerve release) on a previously reconstructed nerve. Patients who experienced failure of nerve reconstruction will be included in the study. During the revisional surgery, nerve fascicles will be released, and ADSCs will be isolated from harvested fat with enzymatic method in a standarized conditions. Cells will be administered through microinjections along the fascicles and around the adjacent tissues after external neurolysis. The follow-up will be continued at least 36 months.

Eligibility Criteria:
Inclusion Criteria:

* clinically definite failure nerve reconstructed patients
* lack of improvement after previous treatment
* without severe, unstable chronic diseases
* Polish citizens

Exclusion Criteria:

* INR \> 2 before liposuction
* primary haematological disease, including hypercoagulable states
* previous/current history of neoplasm or comorbidity that could impact upon patient's survival
* pregnancy /lactation
* alcohol abuse, cocaine amphetamine, etc.
Virtual Reality- Working Memory Retraining

This study will establish the acceptability and feasibility of enrolling and retaining heavy drinking Veterans with mild traumatic brain injury (mTBI) in an 8-week, randomized cross-over design trial of active VR working memory retraining (WMR). This study will also seek to establish the efficacy of active VR-WMR to increase performance in executive function.

The investigators will employ a physically active VR working memory retraining (VR-WMR) regimen utilizing components of Blue Goji VR Active Gaming. The synthesis of physical activity and an enriched VR environment is expected to yield superior working memory training stemming from greater neurological activation. This enhanced working memory training task will result in greater motivation to engage and complete a training regimen, thus fostering greater improvements in executive function than traditional working memory training tasks; ultimately resulting in increased self-control over alcohol use and other high-risk behaviors.

Eligibility Criteria:
Inclusion Criteria:

* must report "heavy" drinking by NIH/NIAAA criteria (\>7 drinks/week for women; \>14 drinks/week for men) for at least one week in the last 90 days
* must meet moderate to severe criteria for current (past year) alcohol use disorder (AUD) by DSM-5
* must express a desire to reduce, stop, or maintain cessation of alcohol use
* must report a history of TBI as defined by American Congress of Rehabilitation Medicine (ACRM), in the chronic, stable phase of recovery (\>6 months from injury)

Exclusion Criteria:

* Unstable medical or psychiatric disorders judged to be unstable in the clinical judgment of the PI
* Current or past history of intrinsic cerebral tumors, HIV infection, cerebrovascular accident, aneurysm, arteriovenous malformations, myocardial infarction, cerebrovascular or peripheral vascular disease, type-1 diabetes, any cardiac, hepatic or renal diseases/disorders, surgical implantation of neurostimulators or cardiac pacemakers, medically diagnosed chronic obstructive pulmonary disease, demyelinating and neurodegenerative diseases, history of seizure disorder, and/or any physical disability making it impossible to use exercise equipment
* No female participant will be pregnant or attempting to conceive
* Concurrent participation in an AUD, cognitive training, or exercise study
* Must not require acute medical detoxification from alcohol (CIWA-AD \> 11) within the past week prior to study entry
* Subjects who, in the opinion of the investigator, are otherwise unsuitable for a study of this type will be excluded
Experiences of a Home-based Virtual Reality Serious Game in People With Chronic Non-specific Neck Pain

Background: Immersive virtual reality (VR) has been used for several years in the treatment of chronic neck pain. This new type of rehabilitation device, which can be used at home, is promising and seems to be as effective as conventional treatments for neck pain. Exploring the experience of people with chronic neck pain using this type of rehabilitation device at home could, among other things, help to understand the factors favoring good adherence and those not favoring it. This could also help us to improve VR home rehabilitation programs according to the patients' needs, preferences and expectations. However, currently, no studies have qualitatively evaluated the experience of people with chronic non-specific neck pain using an immersive VR serious game at home.

Objective: To explore the experience of people with chronic non-specific neck pain who used an immersive VR serious game at home.

Methods: Individual semi-structured interviews will be conducted with people with chronic non-specific neck pain. Interviews will last for approximately 30 to 60 minutes and will be carried out face-to-face or via videoconference (Microsoft Teams), depending on up-to-date guidance relating to the Covid-19 pandemic. Semi-structured interviews will be audio-recorded and transcribed verbatim. The transcripts will be read several times and analyzed using thematic analysis, with themes emerging from the transcripts (inductive approach). These themes will be defined and revised throughout the analysis process.

Discussion: Study findings will help to better understand the experience of people with chronic non-specific neck pain using a VR serious game at home, and then will allow to adapt it to the subjects' needs, preferences and expectations. These adaptations could further increase adherence to treatment and/or improve clinical outcomes for people with chronic non-specific neck pain using this type of rehabilitation device at home.


Eligibility Criteria:
Inclusion Criteria:

* Adults (over 18 years), men or women, living in Belgium
* Chronic (\> 3 months) non-specific neck pain (no specific cause responsible for the neck pain)
* To speak fluent French and to be able to provide informed consent to take part in an interview
* To be able to take part in a semi-structured interview
* No susceptibility to motion sickness, according to the Motion Sickness Susceptibility Questionnaire (MSSQ)

Exclusion Criteria:

* Age under 18 years
* Specific cause responsible for the neck pain (cancer, fracture, etc.)
* Signs of sensorimotor dysfunction (dizziness, vestibular disorders)
* Susceptibility to motion sickness, according to the MSSQ
* Vision problems
* Altered comprehension or inability to speak fluent French
* Inability to provide written informed consent or to take part in a semi-structured interview
Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements

The impact of high-frequency chest wall oscillation therapy on spirometry values (Forced Expiratory Volume, Forced Vital Capacity, Peak Expiratory Flow, Forced Expiratory Flow and Tidal Volume is investigated during use of several products and comparing to baseline values.

The study will be broken into three (3) arms:

* AffloVest® \& The Vest®
* AffloVest® \& inCourage®
* AffloVest® \& SmartVest® Subjects will be randomly assigned to an arm. Within each arm, the order of products will be also randomized.

Baseline spirometry (Forced Expiratory Volume (FEV1), Forced Vital Capacity (FVC), Peak Expiratory Flow (PEF), Forced Expiratory Flow (FEF25-75%) and Tidal Volume (TV)) will be taken at the beginning, middle and end of each series of measurements with each subject, without any device on the subject.

A product (AffloVest or Compressor-based vest) will be placed onto subject and turned ON to the highest frequency and intensity settings. Then the subject will be given a certain period of time to adjust and spirometry measurements will then be repeated, then The product will be removed and the subject will be allowed a recovery period, then the other product will be placed on the subject, turned ON and spirometry measurements will repeated.

Eligibility Criteria:
Inclusion Criteria:

* Healthy subject, ages 18 - 50

Exclusion Criteria:

* Non-ambulatory, diagnosed neuromuscular disorder, currently using any type of oscillation vest therapy, diagnosed co-morbid condition (i.e. lung cancer, other lung disorder or disease), currently enrolled in a medical research study, non-English speaking
The Effect of Intervention About Dry Mouth and Thirst in Patients With Endotracheal Tube

This is an experimental study aimed at exploring the effectiveness of using 4°C frozen gauze with normal saline for relieving dry mouth and thirst in patients with endotracheal tubes.

Long-term placement of endotracheal tubes often causes discomfort, including lip ulcers, laryngeal pain, and dry oral mucosa, leading to frequent complaints of dry mouth and thirst among conscious patients. However, these symptoms are commonly overlooked in the nursing process, resulting in emotional distress and irritability in patients. Although healthcare providers recognize the issue of dry mouth and thirst in patients with endotracheal tubes, effective management is challenging due to concerns about treatment limitations, aspiration pneumonia, and the risk of coughing or vomiting. This experimental study aims to explore the effectiveness of using 4°C frozen gauze soaked in normal saline to relieve dry mouth and thirst in patients with endotracheal tubes.

Eligibility Criteria:
Inclusion Criteria:

* Endotracheal intubation.
* Aged 18 years or older.
* Patient or family members are willing to sign the consent form.

Exclusion Criteria:

* History of head and neck cancer.
* Oral mucosal damage, swelling, or bleeding that precludes placement of a moist gauze pad.
Preoperative Rehabilitation for Patients Undergoing Surgery for Lumbar Spinal Stenosis

The purpose of the present study is to evaluate the effectiveness of a prehabilitation program on the recovery of patients undergoing a minimally invasive surgery for degenerative lumbar spinal stenosis. To do so, 40 participants will be recruited and randomized into two groups; intervention or control group. Participants in the intervention group will take part in a physical training program, three times a week for six weeks before undergoing surgery. The exercise program will be supervised and will aim at improving core muscles strength and endurance as well as spine stability. It is hypothesized that the prehabilitation program will significantly improve disability and pain intensity reported by patients after surgery. Ultimately, this study aims to improve health care of patients awaiting lumbar surgery but its results may also impact the management of patients awaiting spine surgery for various conditions.


Eligibility Criteria:
Inclusion Criteria:

To be affected by degenerative lumbar spinal stenosis and to be awaiting minimally invasive surgery for the lumbar spinal stenosis

Exclusion Criteria:

Non-degenerative spinal stenosis, arthritic conditions (except for facet arthrosis), impaired cognitive function, spinal instability and disagreement from the treating neurosurgeon for the patient to take part in the preadaptation programme.
The Effectiveness of Physical Therapy Modalities in Carpal Tunnel Syndrome

Carpal tunnel syndrome is considered to be the most common entrapment neuropathy. Conservative treatment is recommended in the mild and moderate stage of CTS. The aim of this trial is to evaluate the effectiveness of physical therapy modalities in carpal tunnel syndrome.

Conservative treatment is recommended in the mild and moderate stage of CTS and should involve splinting, steroid injections, oral steroids and ultrasounds .

However, the results of some research studies have showed the beneficial effect of photobiomodulation as well as nerve and tendon gliding exercises in non-operative treatment .

Patients were divided into two groups. The one group received low-level laser therapy (LLLT); the other group underwent ultrasound treatment. Additionally, nerve and gliding exercises were administered in both groups.

The purpose of this trial is to assess the therapeutic efficacy of ultrasound treatment and low-level laser therapy combined with nerve and tendon gliding exercises and to compare the two regimens.

Eligibility Criteria:
Inclusion Criteria:

* diagnosis of the mild or moderate stage of CTS, symptom duration for more than three months and general good health

Exclusion Criteria:

* advanced CTS, secondary CTS, any previous surgery in the upper limb, steroid injections and any physical therapy treatment within six months prior to the study, pregnancy, cervical radiculopathy, peripheral polyneuropathy or other neurological conditions
Evaluation of Leak-Free Bronchoscope Adapter to Limit Ventilated Air Volume Loss During Bronchoscopy

The purpose of this research is to evaluate the ability of a new bronchoscope adapter called "leak-free adapter" to limit the amount of air leaking out to the operating room (OR) from the ventilator in intubated patients who undergo bronchoscopy.

Bronchoscopy is a commonly performed procedure where a camera tipped device is used to look into a patient's lung. To perform bronchoscopy, a "standard commercial adapter" is connected to the ventilator tubing, which lets the doctors use the bronchoscope.The design of the "standard commercial adapter" can cause about 20% of air to escape from the ventilator to the OR. This leaked air causes two issues: first, this can lead to lower oxygen levels and can limit the amount of time your physician can perform bronchoscopy. Second, the leaked air can lead to the spread of harmful particles like anesthesia gas to the OR. These particles can harm the staff in the operating room or spread to other patients in the hospital.

This study will compare the benefit of the "standard commercial adapter" to the newly developed "leak-free adapter". The investigational procedure being studied here is repeating the bronchoscopy with the leak-free adapter. Outcomes (which measure the benefit of the new adapter) will be measured for each adapter independently. Bronchoscopy using both devices will be performed by the physician performing the procedure.

Eligibility Criteria:
Inclusion Criteria:

1. Participants who will be undergoing elective intubation for either a surgical or bronchoscopic procedure (diagnostic or therapeutic)
2. Both males and females
3. Adults 18 years and older

Exclusion Criteria:

1. Significant protocol deviation
2. Significant non-compliance with protocol or study requirements
3. An adverse event which requires discontinuation which results in the inability to continue to comply with study procedures.
4. Consent is withdrawn.