cyrilzakka/clinical-trials huggingface dataset:
The Effect of Intelligent Exercise and Ergonomic Recommendations on Surgeon Musculoskeletal Discomfort

The goal of this clinical trial is to investigate the effects of Intelligent Physical Exercise Training (IPET) and ergonomic recommendations on musculoskeletal pain among abdominal and pelvic surgeons. The main question it aims to answer is:

• Is IPET superior to ergonomic recommendations in rehabilitating or preventing musculoskeletal pain?

12 weeks ahead of trial start, all participants will be familiarized with ergonomic principles in the operating room. In the 20-week trial, the control group is asked to resume practicing and applying the ergonomic principles when they operate. In addition to applying the ergonomic principles, the Intervention group will be asked to perform 50 min. per week of individually tailored physical exercise training. The program is delivered via an application (app).

Pre-intervention The three months leading up to the trial start, all participants are introduced to up-to-date ergonomic recommendations. The ergonomic recommendations are informed by general ergonomic recommendations from the Danish Working Environment Authority, a systematic literature review on the effect of ergonomic interventions applied in the OR (REF and general ergonomic guidelines) and include two recommendations: 1) performing intra-operative microbreaks, and 2) knowledge of ergonomic work posture in the OR.

InterventionIntelligent Exercise app + ergonomic recommendations The duration of the ergonomic recommendations launch period is three months after which consenting participants will be randomized to either the control group or the intervention group. The control group will be encouraged to continue to apply the up-to-date ergonomic recommendations to their OR practice, this will act as usual care. In addition to the usual care, the intervention group will be prescribed individualized physical exercise training (IPET). The IPET is 50 min of tailored physical exercise per week, that is designed by an algorithm that uses the information (demographics, self-reported health, musculoskeletal pain and its location) the individual enters in the app (REF). The 50 min. Of total IPET per week can be performed in one session or divided into shorter sessions two-five sessions with the same effect (REF). The IPET will be delivered through the participants' mobile phone via a mobile application (app) that requires a unique code assigned for each participant. Each participant's exercise training program is different because it is composed of the input provided by the participant. Thus, as the participants experience progress (or deterioration) in their physical capacity during the study, the program will change accordingly.

Eligibility Criteria:
Inclusion Criteria:

* Surgeon in gynecologic-, urologic, colorectal or abdominal surgery
* Performs an average of four hours of surgery per week

Exclusion Criteria:

* Own physician has advised against performing physical exercise training
An Extension of the HORIZON Protocol Evaluating the Safety of Dimebon (Latrepirdine) in Subjects With Huntington Disease

An open-label extension study of the HORIZON protocol evaluating the safety of dimebon (latrepirdine)in subjects with Huntington disease.


Eligibility Criteria:
Inclusion Criteria:

* Successful completion of 26 weeks of blinded treatment in the HORIZON study

Exclusion Criteria:

* Any other medical illness or unstable medical condition that may interfere with their ability to comply with study procedures and abide by study restrictions, or may interfere with the ability to interpret safety information.
The Effect of Motivational Messages by "WhatsApp" on Adherence to Home Exercise Program

This study aims to examine the effect of the text message platform (WhatsApp) on the adherence to home exercise programs, pain and physical function among middle age and older adults with knee OA in two public hospitals in Riyadh city, Saudi Arabia


Eligibility Criteria:
Inclusion Criteria:

Saudi adults aged 45 to 65. Diagnosis of unilateral or bilateral, mild to moderate knee OA

Exclusion Criteria:

Diagnosis of severe knee OA Diagnosis of neurological conditions Diagnosis of cardiopulmonary conditions Diagnosis of mental disorders on wait for surgical intervention.
Upper Cervical and Thoracic Chiropractic Adjustment

The proposed study examines the differences in how the ANS responds to cervical adjustments in comparison to thoracic adjustments. This study is the continuation of a previous study titled Perceived stress and patterns of autonomic function: a protocol development study. Autonomic tests such as HRV, GSR, and the stress surveys will be the primary method of measurement. CareTaker and Biopac devices will provide continual data collection of ECG (for HRV analysis) and GSR throughout the exam and adjustment. Participant's subjective stress levels will be measured through the use of stress questionnaires including the National Stressful Events Survey Acute Stress Disorder Short Scale, the Hamilton Anxiety Rating Scale, and the Connor-Davidson Resilience Scale. The objective of the study is to determine if the location of a chiropractic adjustment will affect the autonomic nervous system in such a way that PNS or SNS activation increases or decreases after the adjustment. Further, the study will continue to examine how the chiropractic adjustment affects the subjective stress response.


Eligibility Criteria:
Inclusion Criteria:

* Over the age of 19
* In good health
* Willing to have blood pressure taken
* Willinig to shave a small area of chest hair for placement of a ECG patch
* Consent to a physical exam
* Consent ot chiropractic evaluationa nd 2 adjustments
Using Mesenchymal Stem Cells to Fill Bone Void Defects in Patients With Benign Bone Lesions

The purpose of this study is to determine whether using mesenchymal stem cells will heal benign bone lesion defects faster than demineralized bone matrix

Orthobiologics have recently become a mainstay in treating bony defects whether related to trauma, tumor, or other various reconstructive entities.1 Historically, benign bone growths that were excised, would be filled with either cement, autograft bone, or allograft substances. More recently, other substances have been utilized. These substances carry any or all osteoinductive, osteoconductive, or osteogenic properties. Various materials have been used to fill bony voids specifically related to benign bone growths. Trinity™ by Blackstone Medical inc. is an allograft substance that has recently began utilization. The difference in Trinity compared to various other allografts is that it utilizes mesenchymal stem cells (MSC) along with an allograft carrier to incorporate and induce bone formation. Previously, in order for stem cells to be included in grafting, it would require bone marrow aspiration and the morbidity that is associated with iliac crest bone grafting.

Trinity MSC's are pre-immunodepleted and therefore, do not stimulate local T-cell proliferation but instead are activated to act as osteoblasts and stimulate bone formation. This local response, could accelerate healing, earlier weight-bearing, healing, and filing of bone voids in patients that have had excision of bony masses. In previous animal models, the use of MSC's have been shown to increase bone healing in critical sized defects.

Trinity is currently approved for FDA use in bone defects specifically within the spine or trauma. It has not been shown to have any significant adverse events over standard bone substitute products. We hypothesize benign bone lesions that undergo curettage and filling with Trinity will heal faster than bone lesions filled with basic bone grafting.

Eligibility Criteria:
Inclusion Criteria:

* Ages \> 11 years
* Benign bone lesion

Exclusion Criteria:

* Previous surgery
Effect of Fenofibrate on Sleep Apnea Syndrome

Objectives: to investigate for the potential effect of fenofibrate on symptoms and biological changes associated with sleep apnea syndrome.


Eligibility Criteria:
Inclusion Criteria:

* Having previous diagnosis of sleep apnea not treated with Continuous Positive Airway Pressure (CPAP) or presenting clinical symptoms of sleep apnea
* Overweight or obese, with BMI \>= 25 kg/m² and \< 40 kg/m².
* Known moderate hypertriglyceridemia, with fasting Triglycerides level \>= 2.0 and \< 6.0 mmol/L within 3 months before the inclusion.

Exclusion Criteria:

* indication for immediate CPAP
* other known endocrine disease, except treated and adequately controlled hypothyroidism
* renal failure or plasma creatinine level \>130 µmol/L
* current chronic liver disease or ALanine Amino Transferase (ALT)\> 2 times the upper normal limit (UNL)
* symptomatic gallbladder disease
* known muscular disease or creatine phosphokinase (CK) \> 3 times UNL.
Sacral Neuromodulation in Neurogenic Patients

The goal of this observational study is to evaluate efficacy and safety of sacral neuromodulation in neurogenic patients compared to non-neurogenic (idiopathic) patients. \[. The main question\[s\] it aims to answer are:

* determine efficacy and safety of the therapy in neurogenic patients.
* compare outcomes of the therapy to idiopathic patients.

If there is a comparison group: Researchers will compare the outcomes of the therapy between the neurogenic and non-neurogenic subset of patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients who underwent InterStim II advanced evaluation for approved indication

Exclusion Criteria:

* N/A
Interest of a Systematic One-year Monitoring by 18F-FDG PET-CT

In the study, we aimed to characterize the role of FDG PET/CT surveillance at 12 months of malignant lymphoma in asymptomatic patients after a first complete remission and to define a rational follow-up strategy.

Most aggressive lymphomas are sensitive to first-line immunochemotherapy and are in first Complete Remission (CR) with initial therapy. CR significantly decreases the risk of recurrence and increases survival. However, a cure is not guaranteed and approximately one third of lymphoma patients have a relapse disease.

FDG PET/CT is a valuable noninvasive tool in the evaluation of lymphomas, especially to differentiate viable lymphoma and fibrosis or necrosis in residual mass.

The majority of relapses are diagnosed based on clinical symptoms reported by patients. And the role of FDG PET/CT for routine surveillance of patients after treatment is controversial.

However, many medical centers use routine follow-up FDG PET/CT in addition to physical examination and laboratory analysis to detect subclinical relapse.

Thus, we can imagine a good timing to routine FDG PET/CT when the tumor burden is small in the asymptomatic window.

Survival improvement for relapse detected by routine follow-up imaging is not clearly established compared to diagnosis by clinical symptoms.

Several studies tried to assess the value of follow-up FDG PET/CT but population, type, timing and duration of surveillance imaging was very heterogeneous.

Eligibility Criteria:
Inclusion Criteria:

* first diagnosis of aggressive lymphoma, complete metabolic remission after a first-line of chemotherapy, no relapse in the first year after the end of treatment

Exclusion Criteria:

* minor patient, pregnant woman, legal protection (legal curatorship / guardianship), absence of consent
Virtual Reality Cognitive Training for Mild Cognitive Impairment

This study aims to assess the feasibility and efficacy of a 10-weekly multi-domain VRCT program on the cognitive function (i.e. attention, memory, and executive functioning) of older adults with MCI.

This study employed a pilot feasibility parallel design approach. Participants were randomly assigned to either the VRCT intervention group or the active control group. The outcome assessor was blinded. Participants were recruited from outpatient clinics in Changi General Hospital, Singapore. They were referred by treating geriatricians and psycho-geriatricians.

Eligibility Criteria:
Inclusion Criteria:

* aged 65-85
* diagnosis of MCI by a clinician in accordance to Petersen's criteria
* MMSE ≥ 23
* ability to see and hear
* ability to read and write in either English or Mandarin

Exclusion Criteria:

* diagnosed with a primary other neurocognitive disorder
* diagnosed with major psychiatric illness such as major depressive disorder or anxiety disorder, severe visual or auditory impairment
* diagnosed with serious medical illnesses including acute or severe asthma, severe or unstable cardiovascular disease, active gastric ulcer, severe liver disease or severe renal disease.
Low or High Dose of Dexamethasone in Patients With Respiratory Failure by COVID-19

After RECOVERY trial publication, low dose (6 mg dexamethasone for 10 days) was recommended as the usual care treatment in hospitalized patients with respiratory failure by COVID-19 needing oxygen therapy. RECOVERY trial showed how the use of dexamethasone 6 mg / day for ten days compared to standard treatment without the use of corticosteroids in hospitalized patients reduced mortality at 28 days (22.9% with dexamethasone vs 25.7% without dexamethasone). In the dexamethasone group, the incidence of mortality was lower than standard treatment in patients with hypoxia and the need for mechanical ventilation (29.3% with dexamethasone vs 41.4% without dexamethasone), in patients admitted to the hospital ward with a need for oxygen therapy (23.3% with dexamethasone vs 26.2% without dexamethasone), but they did not find differences between those admitted patients who did not need oxygen therapy. There are two other studies (DEXA-COVID-19 and CoDEX) where they observed benefits of the use of dexamethasone 20 mg / day 5 days, and 10 mg / day 5 days (total 10 days) in patients admitted for respiratory distress syndrome (ARDS) and COVID-19. At present, it is unclear what dose of dexamethasone is most beneficial in patients with COVID-19 and respiratory failure.

Objective: The investigators aim to assess the efficacy of high dose of dexamethasone (20 mg / day 5 days, and 10 mg/day 5 days) versus low dose of dexamethasone (6 mg/day 10 days) in patients with respiratory failure by COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older.
* Hospitalized COVID-19 patients admitted to the Hospital.
* Patients requiring supplemental oxygen. Level 4 using the World Health Organization 7-point Ordinal Scale for clinical improvement
* Patients requiring corticosteroids (dexamethasone) according to Hospital protocol.

Exclusion Criteria:

* Pregnancy or active lactation.
* Patient is expected to die in the next 48 hours.
* Known history of dexamethasone allergy or known contraindication to the use of corticosteroids.
* Daily use of corticosteroids in the past 15 days.
* Indication for corticosteroids use for other clinical conditions (e.g. refractory septic shock).
* Consent refusal for participating in the trial.
* Different level of 4 in Level 4 using the World Health Organization 7-point Ordinal Scale for clinical improvement.
Phase II Evaluating Efficacy of Temsirolimus in 2 Line Therapy for Patients With Advanced Bladder Cancer

In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival.

In the absence of standard treatment in this indication, this test evaluates a new drug type targeted therapy in this indication, evaluating its efficacy in terms of tumor response and survival. This study will also search for genes involved in the response to treatment.

Eligibility Criteria:
Inclusion Criteria:

* Men or women of at least 18 years of age
* Histologically proven Bladder cancer
* Locally advanced or metastatic disease (stage IV)
* Functional status (ECOG / OMS) ≤ 2
* Relapse after first-line chemotherapy
* Measurable lesions (RECIST criteria)
* Absence of anti-neoplasic treatment in the 4 weeks preceding inclusion.
* Biological levels :
* Neutrophil count \>1,5.109/L.
* Platelets \>100.109/L
* Total serum bilirubin \< 1.5 × ULN
* Clearance of créatinine 40 ml/mm
* If not liver metastasis alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<2.5 × ULN
* With liver alanine aminotransferase (ALT) and aspartate aminotransferase (AST) \<5 × ULN
* Signed informed consent
* Both women and men must agree to use a medically acceptable method of contraception throughout the study. Women of childbearing potential must have a negative serum pregnancy test of or less than 7 days before the first perfusion of study.
* France only : Patients affiliated to a social security program

Exclusion Criteria:

* Presence of metastatic brain or meningeal tumors on selection scanner, weither symptomatic or asymptomatic
* Chemotherapy, immunotherapy, or radiotherapy within 4 weeks of inclusion
* Known hypersensitivity to temsirolimus, or its metabolites (as sirolimus), or polysorbate 80 or to their excipients
* Previous malignancy (except for cervical carcinoma in situ, basal cell carcinoma curatively treated) or incidental (≤ pT2) prostate cancer found on a radical cystoprostatectomy material
* The drugs known as CYP3A4/5 inhibitors or inducers will specifically be excluded on the 30th day ( or at least 7 halves-lives, according to the shortest duration) before the first perfusion and throughout the study. Any food known to inhibit CYP3A4/5 (for example grapefruit, grapefruit juice, star-fruit or star-fruit juice) will also be purposely excluded.
* Auto-immune pathology, psychiatric or neurological disorder
* Any unstable medical condition
* Unstable cardiac disease
* Severe renal failure
* Unstable diabetes
* Pregnancy
* Patient enrolled in another therapeutic clinical trial
* Patient unable to follow and comply with the study procedures because of any geographical, social or medical condition
* Patient partially or totally deprived of his civil rights
Comparative Evaluation of Periglottic Airway Devices With Performed Shape

The purpose of this study is to evaluate four, most popular periglottic airway devices as regards to ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberscope).

After being informed about the study and potential risks, all patients (\>18 years old scheduled for elective surgery under general anesthesia) giving written informed consent will undergo preoperative screening examination to determine eligibility for study entry. A randomization process has been previously done, according to which the participants have been classified into one of the four groups of the study. Each study group is scheduled to receive one of the four periglottic devices (LM FastrachTM, LM ProsealTM, LM I-GelTM, LM ProtectorTM) while evaluating the ventilation sufficiency and perfection of installation/ anatomical application to the larynx (evaluation with fiberscope).

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years old, undergoing elective surgery under general anesthesia

Exclusion Criteria:

* Patients \< 18 years old
* Patients undergoing emergency surgery or trauma patients
* Obstetric population
* Patients receiving regional anesthesia
* Patients to whom the use of periglottic airway device is contraindicated
* Patients with RODS score ≥ 1 (score to predict difficult laryngeal mask placement 1-4)
* Patients with anticipated difficult airway, planned for awake intubation
* Patients' refusal to participate in the trial
Prospective Database for Chronic Myelogenous Leukemia

Prospective Database for Chronic Myelogenous Leukemia


Eligibility Criteria:
Inclusion Criteria:

* Patients with CML
Transcatheter Mitral Valve Replacement With the Medtronic Intrepid™ TMVR System in Patients With Severe Symptomatic Mitral Regurgitation.

Multi-center, global, prospective, non-randomized, interventional, pre-market trial. All subjects enrolled with receive the study device.


Eligibility Criteria:
Inclusion Criteria:

* Moderate to severe or severe symptomatic mitral regurgitation
* Local site multidisciplinary heart team experienced in mitral valve therapies agrees that the subject is unsuitable for treatment with approved transcatheter repair or conventional mitral valve intervention

Exclusion Criteria:

* prior transcatheter mitral valve procedure with device currently implanted
* anatomic contraindications
* prohibitive mitral annular calcification
* left ventricular ejection fraction \<25%
* need for emergent or urgent surgery
* hemodynamic instability
Augmenting Virtual Reality Exposure Therapy for Acrophobia

This study will examine whether tactile feedback and point-based rewards can be used to improve outcomes from virtual reality exposure therapy for acrophobia.

Exposure therapy is one of the most potent techniques available for treating anxiety-related disorders, including specific phobia. However, estimates suggest that 10-48% of anxiety patients do not fully respond to exposure therapy. Meta-analyses demonstrate that virtual reality exposure therapy (VRET) is equally effective as traditional, in vivo ('in life') exposure therapy. Furthermore, individuals with anxiety disorders report greater preference (and lower likelihood of treatment refusal) for VR, rather than in vivo, exposure therapy. Although VRET has well-established efficacy and is rapidly growing in popularity, there has been very little research evaluating how specific elements of VR game design might be used to improve outcomes from VRET. This study evaluates two game design elements that we hypothesize will improve VRET outcomes: tactile feedback and a point-based reward system. Tactile feedback (TF; i.e., touching a real object that matches an element in the VR environment) enhances sense of presence in VR. Higher presence activates anxiety during VRET, which is essential for promoting the active mechanisms of exposure therapy and may also improve treatment retention. On the other hand, point-based rewards (PR) in games enhance sense of competence (i.e., sense of progress and achievement), and increase both enjoyment and likelihood of future use of games. Furthermore, several studies demonstrate that PR improves traditionally difficult-to-change health behaviors, such as increasing exercise frequency and reducing misuse of pain medications. Although this research is promising, the impact of PR on VRET is unknown. To test the influence of TF and PR on VRET outcomes, we will randomize participants with acrophobia to receive (a) standard virtual reality exposure therapy, (b) VRET with tactile feedback, (c) VRET with a point-based reward system, or (d) VRET with tactile feedback and a point-based reward system. Participants' fear reactivity will be assessed with behavioral, physiological, and subjective/self-report measures at baseline, post-treatment, and follow-up.

Eligibility Criteria:
Inclusion Criteria:

* Fluent in English
* Indicates sufficient fear of heights based on responses (a) on a self-report questionnaire (the Acrophobia Questionnaire) administered at prescreening, and (b) on Behavioral Avoidance Tests administered at baseline.

Exclusion Criteria:

* Already receiving exposure therapy for height phobia