cyrilzakka/clinical-trials huggingface dataset:
NIV in Covid-19 Respiratory Failure

A retrospective, single centre observational study to validate use of the HACOR score (Duan et al, 2017) in determining efficacy of non-invasive ventilation in Covid-19 respiratory failure.

The investigators will retrospectively analyse medical records of patients with confirmed Covid-19 respiratory failure who received continuous positive airway pressure (CPAP) via facemask, as per clinician decision, in the High Dependency Unit (HDU) or Intensive Care Unit (ICU) of University Hospital Crosshouse between 1st March 2020 and 30th April 2021. By collecting baseline demographics and physiological data (including APACHE II and clinical frailty score) and calculating the HACOR score at initiation of CPAP, then at 1hr, 6hrs, 12hrs, 24hrs and 48hrs after initiating CPAP the investigators aim to validate use of the HACOR score in determining efficacy of NIV in Covid-19 respiratory failure. The investigators will also collect other variables (CRP and lymphocytes, lactate, mean arterial pressure, temperature) to determine if these factors have utility in predicting efficacy of NIV in Covid-19 respiratory failure.

Eligibility Criteria:
Inclusion Criteria:

1. Confirmed Covid-19 respiratory failure
2. NIV treatment instituted as per clinician decision
3. Admitted to HDU or ICU between 1/3/20 and 30/4/21

Exclusion Criteria:

1. Patients with immediate indication for invasive ventilation
2. Patients whose primary diagnosis was not Covid-19 respiratory failure, but received NIV in that time period
Superior Gluteal Neuropathy -Total Hip Arthroplasty

A prospective study of 50 consecutive patients undergoing total hip arthroplasty, to establish whether there greater incidence of injury to the superior gluteal nerve associated with a particular approach (modified direct lateral approach). The patients will be assessed clinically and electrophysiologically before and after the operation through one year.

Neurological complications following total hip arthroplasty are uncommon, and their impact ranges from transient and trivial to permanent and devastating.

In general, the prevalence rate of neurologic injury after primary hip arthroplasty is estimated as 0.7-3.5% , whereas it may increase up to 7.6% after revision hip arthroplasty.

Direct or indirect injuries of nerves may occur during operative exposure and subsequent procedures. Injuries to the peripheral nerves can come about in several ways: laceration, ischemia, mechanical deformation from compression or distraction, or a combination of these causes.

Peripheral nerve injuries can involve either distant sites or nerves in the immediate vicinity of the hip joint. Sciatic nerve injury is the most common nerve to be injured following total hip arthroplasty. Femoral nerve injury is much less common and is associated with an anterior approach. Its diagnosis is often delayed, but the prognosis is generally better than with sciatic nerve injury.

The direct lateral approach to the hip was described by Hardinge and is based on the observation that the gluteus medius and vastus lateralis are in functional continuity through the thick tendinous periosteum covering the greater trochanter.

This approach involves splitting the gluteus medius and retracting a portion of the muscle anteriorly in continuity with part of the vastus lateralis. It avoids trochanteric osteotomy, but the neurovascular supply of gluteus medius and tensor fascia lata is vulnerable.

The superior gluteal nerve may be compromised during total hip arthroplasty done through the direct lateral approach of Hardinge which puts this nerve at risk when the gluteus medius is split and retracted anteriorly.

The function of the abductors may be impaired after operation if there is damage to the superior gluteal nerve or if the muscle flap is reattached inadequately to the trochanter.

Eligibility Criteria:
Inclusion Criteria:

* Age: adults
* Sex: both males and female
* Operation: unilateral primary total hip replacement

Exclusion Criteria:

* Patient refusal
* Patients with pre-existing neuromuscular abnormality
* Preoperative immobility
* patient with bilateral total hip arthroplasty or hip pathology
* Revision hip arthroplasty
An APP That Can Provide Early Warning of Temperature Health Risks and Give Protective Suggestions or Personalized Suggestions Based on Patients' Own Secondary Prevention Risk Factors Was Applied to Intervene, and the Intervention Effect of APP on Stroke Recurrence Risk Was Analyzed

This study employs individualized temperature health risk early warning and risk factor management interventions for stroke, and explores their actual intervention effects. This enables patients to promptly understand their own risk levels and take corresponding protective measures, thereby enhancing the management outcomes and quality of life. The study also promotes the interdisciplinary integration of environmental epidemiology and clinical intervention management, providing new ideas and methodological support for future relevant research.


Eligibility Criteria:
Inclusion Criteria:

* Aged 40 to 80, with no gender restrictions;

  * Acute ischemic stroke inpatients within 2 weeks of onset, where the onset time is the time when stroke symptoms appear or the last known normal time of the patient (when it is an onset during sleep or the symptom onset time cannot be accurately obtained due to aphasia, impaired consciousness, etc.); ③ Confirmed diagnosis of ischemic stroke by CT or MRI of the brain within 2 weeks after symptom onset;

    * Local residents (residing for ≥6 months); ⑤ Patients who voluntarily participate in the study, have high compliance, and can sign the informed consent form;

      * Patients who own a smartphone or other smart devices.

Exclusion Criteria:

* Patients diagnosed with other cerebrovascular diseases (hemorrhagic stroke, transient ischemic attack, cerebral venous sinus thrombosis, etc.) or non-cerebrovascular diseases;

  * Known pregnant or lactating women, or those who tested positive on a pregnancy test before cluster randomization;

    * Patients with other conditions that may affect participation in the trial (e.g., refractory hypertension, severe aphasia, etc.);

      * Patients undergoing psychiatric/psychological treatment that may contaminate the results; ⑤ Patients with a life expectancy of less than one year (e.g., coexisting malignant tumors, severe cardiopulmonary diseases, etc.); ⑥ Patients already participating in other interventional clinical studies that may influence the outcome assessment; ⑦ Patients for whom the investigator deems unsuitable for participation in this study or who may pose significant risks to the patients (e.g., cognitive impairment preventing understanding and/or compliance with the study procedures and/or follow-up).
Robotic Surgery of the Ocular Surface

The introduction of surgical robots in the OR revolutionized a number of specialties (i. e. urology, gynecology, digestive surgery). Robots are currently used in many situations and the list of appropriate indications is growing rapidly. There are many potential advantages of robotics in eye surgery such as increased precision and maneuverability, better ergonomics, improved patient access to surgeons and surgical training. As a result, robotics might improve patient care. The Da Vinci© robot has been used for 10 years in experimental conditions to suture corneal lacerations, to perform corneal grafts, to remove ocular foreign bodies, lens capsules and vitreous. The authors reported a lack of precision resulting from poor visualization and the absence of microsurgical instruments. These elements were considered to be hurdles to further clinical investigation. The new Da Vinci Si HD© robot has been available since 2009 at the IRCAD center and more recently in Strasbourg University Hospital. It provides greater magnification and better resolution of the operative field than the previous model. We performed since 2012 various ocular surface surgeries on porcine eyes at the IRCAD center. The aim of the present trial is to perform the same procedures (amniotic membrane transplantations, pterygium surgeries, corneal grafts) in a clinical setting with the Da Vinci Si HD© system.


Eligibility Criteria:
Inclusion Criteria:

* Adult patient \> 18 year-old suffering :

symptomatic pterygium

* chronic corneal ulceration resistant to medical treatment
* corneal opacity involving corneal stroma and corneal endothelium
* corneal thinning
* corneal perforation

Exclusion Criteria:

* History of eye surgery
* psychiatric disease
* mental deficiency
* pregnancy
* nursing mother
Selenium, as Sodium Selenite, in the Treatment of Septic Shock

Septic shock is a frequent syndrome with a 45% mortality rate despite intensive care unit (ICU) care, where free radicals may play a key role, and a \>40% decrease in plasma selenium concentration is observed. Selenium is a trace element with both indirect enzymatic anti-oxidant, and direct oxidant properties. High dose of sodium selenite administration could increase antioxidant cells capacities, and reduce inflammation by a direct paradoxical pro-oxidative effect. We conduct a study to evaluate the effects of selenium treatment in comparison to placebo, in septic shock patients. Efficacy will be evaluated by the weaning time of catecholamines.

Septic shock - an uncontrolled systemic host response to invasive infection -, leading to multiple organ failure, is a public health issue because of its frequency (\> 1/1000 inhabitants per year), its cost and its 45% mortality rate, remaining high despite all the improvements made in ICU for the past 20 years. His physiopathology is better understood with increasing data supporting the key role of free radicals, and a more than 40% plasma selenium concentration decrease that maybe associated with increased morbidity and mortality. Meanwhile, for the past 30 years, researches have been conducted on the essential trace element selenium for its requirement for key antioxidant enzymes, through the 21st aa selenocystein, and also for its potentially toxic, pro-oxidant properties. In septic shock, both properties may be useful, antioxidant enzymatic to increase cell defense especially endothelial cells, and direct pro-oxidant action to decrease the genomic response, especially on phagocytic cells.

The objective of this study is to evaluate the effects of a high dose of selenium administration, such as selenite, at pro-oxydant initial dose followed by anti-oxidant dose in severe septic shock patients with documented infection. The initial dose was chosen as the highest dose of selenium, as sodium selenite, estimated without severe adverse effects in healthy people for a one-day ingestion. The patients are randomized to receive either the placebo or the selenite at this high initial dose followed by lower doses on a 9-day period. The efficacy will be evaluated by the weaning time of catecholamines, with a special attention to the 6-month mortality rate as first secondary end point.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalization in ICU
* Severe documented infection
* Ventilation
* Circulatory failure requiring high dose of catecholamine
* IGS II score \>25 at inclusion
* Informed written consent

Exclusion Criteria:

* Pregnancy
* End phase chronic disease
* Limitation of care
* Shock due to an urinary infection without bacteriemia
* Peritonitis related to peritoneal dialysis or trauma
* Preliminary circulatory failure
* Participating to another clinical trial
Radiofrequency Ablation for Barrett Oesophagus With Low Grade Dysplasia

Radiofrequency ablation versus endoscopic surveillance in the management of low grade dysplasia in Barrett oesophagus: a multicentric randomised controlled trial.

Background: The occurrence of low grade dysplasia (LGD) in Barrett oesophagus (BE) is known as a pre-cancerous state. Current recommendation in case of LGD is a close endoscopic surveillance every 6 to 12 month and continuous Proton pomp inhibitor (PPI) treatment. Endoscopic radiofrequency ablation (RFA) has been demonstrated as an efficient treatment to eradicate high grade dysplasia (HGD) and most of LGD and BE.

Main aim of this study: To demonstrate that the prevalence of patients with LGD 3 years after a RFA treatment is lower than in a surveillance group.

Patients \& Methods: French multicentric randomized controlled trial for patients with BE with confirmed LGD: RFA vs endoscopic surveillance.

120 patients are planned to be included for at least 40 patients randomized in each group.

Primary endpoint: Prevalence of LGD in each group 3 years after randomization

Secondary endpoints:

* Prevalence of LGD in each group 1 and 5 years after randomization
* Rate of complete eradication of BE at 1, 3 and 5 years after randomization
* Incidence of HGD and adenocarcinoma at 3, 5 years after randomization
* Rate of complications in RFA group after randomization
* Cost - efficacy comparison of the 2 strategies

Eligibility Criteria:
Inclusion Criteria:

* BE with certain LGD in at least one endoscopic biopsy sample
* BE with maximal length of 12cm (Prague classification ≤ C12)
* BE with minimal length of 1cm circumferentially or 3cm in case of a unique zone (Prague classification ≥ C1 or C0M3)
* Patients aged between 18 and 80 years
* Patients' consent for study enrollment
* No contra-indications to general anaesthesia
* Patients ability to take PPI oral medication
* Patient affiliated to a social security system
* No pregnancy and active contraceptions for women in age to procreate
* In case of previous endoscopic mucosal resection for HGD in BE: at least one year of surveillance and 2 biopsy series with LGD without HGD

Exclusion Criteria:

* BE length \> 12cm or \< 1cm circumferentially (\< C1) or \< 3cm focally (\<M3)
* HGD or adenocarcinoma needing a specific endoscopic or surgical treatment
* Active peptic oesophagitis (Savary III or IV)
* Presence of surgical staples on the area to be treated
* Radiation oesophagitis of radiotherapy whose field includes the lower oesophagus
* previous oesophagus cancer
* previous endoscopic destruction treatment such as photodynamic therapy or plasma argon coagulation
* previous Heller surgery
* oesophagus stenosis
* oesophagus varices
* oesophagus pathology associated with sclerodermia
* Severe coagulation disorders or thrombopenia
* Anaesthesia contra-indications (ASA 4)
* Hypersensitivity to fluorescein or any component of the fluorescein
* Life expectancy \< 2 years
* Disability to take PPI oral medication or follow the protocol surveillance Schedule
Transcutaneous Magnetic Spinal Cord Stimulation for Freezing of Gait in Parkinson's Disease

Dopaminergic drugs partially alleviate gait problems in Parkinson's disease, but the effects are not sustained in the long-term. Particularly, the freezing of gait, balance problems and other gait issues directly impacts patients' quality of life. Experimental epidural spinal cord stimulation studies have suggested positive effects on locomotion among PD patients, but the effects of non invasive stimulation have never been explored.

The present study is a randomized, double-blind, placebo-controlled, parallel, phase II clinical trial that will assess the efficacy and safety of transcutaneous magnetic spinal cord stimulation in PD patients who have gait and balance changes refractory to dopaminergic therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Men and women (not pregnant) aged between 21 and 80 years old;
2. Participants with idiopathic Parkinson's disease in Hoehn Yahr stages between 2 and 4 (moderate disease) during off-medication, whose primary symptom includes change in gait and / or balance (score equal to or greater than 1 in subitem 2.12 of the MSD scale -UPDRS \["gait and balance"\]). The participant must also present freezing (block) of gait (score equal to or greater than 1 in sub-item 2.13 of the MSD-UPDRS scale - "freezing"). Patients should experience the above symptoms even though they are optimized from the medication point of view. The criteria for being optimized will be defined by a neurologist specialized in movement disorders who will evaluate the case. The presence of freezing will be confirmed through a specific scale (FOG score).
3. Mini-examination of mental status greater than or equal to 24 points;
4. Able to give informed consent in accordance with institutional policies;
5. Able to meet all testing and monitoring requirements, as defined by the study protocol;

Exclusion Criteria:

1. Patients with unstabilized psychiatric comorbidities
2. Impossibility to consent to your participation in the study.
3. Patients with uncontrolled infection or other pre-existing uncontrolled medical conditions (eg, decompensated diabetes, high blood pressure, pneumo or symptomatic heart disease).
4. Concomitant treatment with other experimental drugs.
5. Pregnant or breastfeeding women.
6. Presence of chronic pain in the lower limbs.
7. Patients who are unable to walk without assistance (cane, crutch, walker) or help from another person when they are without their medications for Parkinson's disease (off-medication).
Comparison of Interventions to Promote Health in Workers

The goal of this research was to investigate different intervention strategies in the workplace and their impact on quality of life of workers from companies in the city of Londrina, Parana, Brazil.

The interventions were composed by exercise in the workplace and educational interventions.

The workplace has special features about human behaviors. Studies (Shepard 1996, Pratt 2008) has shown that workers participate of this kind of health promotion programs for various reasons: One reason is the convenience of doing something without having to look for it; another reason is group support, many workers who share difficulties due to their working demands can find support in each other, so that they could change health behavior. Furthermore there are patterns of formal and informal communication that can contribute to help more people to become healthier making their environment better. Finally, the norms of a corporate behavior can unite the group of workers seeking same objectives.

Additionally the literature has shown that adults increased workload, job insecurity and pressure to perform tasks (Sparks 1997). These facts has been shown that workplace is different from community based interventions and leisure interventions.

The outcomes proposed to study are different from other studies since the interventions focus changes in behaviors. Sedentary behavior has shown to have 23% of deaths from major chronic disease (WHO 2002).

As the populations rises around the world and with the prolonged life expectancies, the number of people with chronic diseases will raise (WHO 2006). By having positive changes in health behavior the costs of public health can be reduced. Studying different types of interventions and testing its efficacy in different places can help the policy makers to create healthier environments.

There are strategies being developed in the workplace, but its efficacy is being challenged. There are some researches that show no evidence to prove the continuity of these interventions and there are evidences proving the opposite, positive changes in clinical outcomes as diabetes, blood pressure and elevated blood cholesterol. In addition some measures as BMI, anthropometric, fitness level have shown good association as prediction of development of chronic disease with low cost (Dishman 2004).

Eligibility Criteria:
Inclusion Criteria The inclusion criteria for participation of these study were never participated of and quality of life and health intervention program at work and had an interest in participating in the study. Included workers ≥ 18years who had to work in the office position, sitting at the computer most of the work shift.

Exclusion criteria: temporary workers and freelancers.
The Effect of PEMF for Patients With Knee OA

Health care costs are increasing alarmingly, which will impose an overwhelming economic burden to an aging society like that of Hong Kong. For example, degenerative musculoskeletal disorders such as osteoarthritis (OA) present a grand challenge with its high prevalence (\>40% in the elderly suffered from knee OA). OA is a debilitating progressive disease with typical symptoms such as acute pain causing loss of mobility Currently there is no cure for OA. Pharmacological treatment and new regenerative technologies such as stem cell therapy are actively being developed, but most of these options are very expensive per se, and side effects are not uncommon. Costeffectiveness is also a major consideration for devising new therapeutic modalities for OA.

There are emerging evidences showing that pulsed electromagnetic field (PEMF) can modulae mitochondrial activities for muscle gain. PEMF exposure on top of regular exercise training may promote muscle regeneration and tissue healing.

This study aims to conduct a double-blinded, randomized controlled trial to investigate the effect of PEMF treatment on knee pain in patients with knee OA. We hypothesize that PEMF treatment is effective to relief in pain and improve knee function in Knee OA subjects.

Based on the aim of this study, older adult patients (aged 50 or above) with knee OA with Kellgren-Lawrence grade 2-4 by X-ray, have sedentary lifestyle (Tegner activity level less or equal to 3), no acute knee injuries in past 12 months, no muscle strain in past 12 months and not degenerative joint disease in other joints except the involved knee.

To estimate the improvement of patients, isometric quadricep muscle strength, posture assessment, serum myokine level, serum vitamin D level and selfreported outcome with questionnaires will be performed.


Eligibility Criteria:
Inclusion Criteria:

1. Age 50 or above
2. knee OA with Kellgren-Lawrence grade 2-4 by X-ray
3. Sedentary lifestyle (Tegner activity level ≤ 3)
4. No acute knee injuries in past 12 months
5. No muscle strain in past 12 months
6. No degenerative joint diseases in other joints except the involved knee

Exclusion Criteria:

1. Age smaller than 50 years old
2. Experienced any concomitant bone fracture, ACL injury, major meniscus injury
3. Any rheumatological diseases
4. Metal implants that would cause interference on MRI
5. Previous contralateral knee injury
6. Recent knee injections (prior 3 months)
7. Physical inability to undertake testing procedures
8. Pregnancy or possibility of pregnancy
Behaviour and Cognitive Evaluation for Dialysis Elderly Patients (BCDE)

The trial is a multicenter, prospective, randomized, open study. A total of 500 elderly patients aged over 75 years with renal insufficiency stage 5 will be included in the study after signed informed consent. Patients will be randomized 1/1 in two arms : 250 patients in the "exclusive nephrology follow-up" arm will continue their usual follow-up; 250 patients in the "geriatric follow-up" arm will have both their usual nephrology follow-up and a geriatric follow-up.The aim of the study is to determine if a systematized gerontologist evaluation delay the occurrence of a composite primary endpoint : death, dementia, depression and severe dependency. The hypothesis is that the functional and vital prognosis of a patient with renal insufficiency depends not only on common and classical factors but also on cognitive and psychological functions and dependence, particularly in elderly patients.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged of 75 years old or more,
* Chronic kidney disease stage 5 defined by :
* either an estimated GFR (MDRD) ≤ 15ml/mn/1,73 m² in a non-dialysis patient whatever the duration of previous monitoring by the nephrologist("Pre-dialysis cohort"),
* or a dialysis treatment started for more than 3 months and less than one year, whatever the duration of pre-dialysis follow-up by the nephrologist("post-dialysis cohort"),
* Signed and dated informed consent.

Exclusion Criteria:

* Moderately severe to severe dementia (MMS ≤ 15),
* Major depression and/or GDS-15 \> 10/15,
* Severe dependency (ADL \< 3/6),
* Psychosis, mutism or aphasia,
* Malignancy or any pathology with life expectancy \< one year,
* Ongoing specialized geriatric care