cyrilzakka/clinical-trials huggingface dataset:
Robot-Assisted Partial Knee Replacement Versus Standard Total Knee Replacement

This is a pilot randomized trial to assess the feasibility of a definitive trial to determine the effect of robot-assisted partial knee replacements versus standard total knee replacements.

Knee osteoarthritis (OA) pain is an important source of morbidity and cost to the health care system. Over 60,000 knee replacement surgeries are performed in Canada every year, making it the second most common surgery. Our institution (St. Joseph's Healthcare Hamilton) is the first hospital in Canada to purchase a Mako RIO orthopaedic robot to assist with performing knee replacements. The knee is divided into three compartments, and one, two, or all three compartments can become arthritic. Over 90% of patients with end-stage knee OA receive a total knee replacement (also known as total knee arthroplasty or TKA) even if they have one or two healthy knee compartments. Partial knee replacements are an option for these patients but these procedures are very technically demanding and associated with a higher risk of implant failure. For this reason, few surgeons are experts at partial knee replacements. We believe that we can use robotic technology to make it easier for surgeons to perform partial replacements more accurately, thereby increasing the quality and survivorship of partial knee replacements. This may lead to better patient-important outcomes like return to activity, pain, and satisfaction, and eventually better access to high-quality partial knee replacements for Canadians. This will be the first study to evaluate total knee replacements (standard care) versus robot-assisted partial knee replacements, and could lead to greater uptake of robotic technology in orthopaedics and a shift toward anatomy-sparing partial knee replacements.

Eligibility Criteria:
Inclusion criteria

* Adult (18+)
* Unicompartmental knee OA with or without concomitant patellofemoral OA, requiring surgical treatment
* Two study surgeons independently agree that the patient is eligible for either treatment group

Exclusion criteria

* Inability to provide informed consent (e.g. cognitive disability, language barrier)
* Revision knee surgery
* Simultaneous bilateral knee surgery
* Previous major knee surgery or trauma
* The robot or required components are unavailable (e.g. technical difficulties, robot-specific disposables out of stock)
* A CT scan cannot be obtained prior to surgery
* Patient does not wish to participate
The Effect of Long-term Momordica Charantia Supplementation on Blood Glucose Levels

The study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. Research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. The main study parameter is fasting levels of plasma glucose.

Bitter gourd (BG) (Momordica charantia) is a highly nutritive vegetable from the cucumber family. The objective is to assess the impact of 12-weeks of BG supplementation on blood glucose levels in subjects with impaired fasting glucose levels. In a previous trial (Bitter-Zoet NL70259.081.19) the short-term effects of BG (4 weeks) were studied, but no effect was observed. In the current trial a different BG cultivar is chosen, the intervention period is prolonged, the dosage per day is higher and study subjects with slightly higher fasting blood glucose levels will be included. The study is a parallel, double blind, controlled trial in which study participants will receive a 12-week intervention with 3.6 g/d dried bitter-gourd supplements or a reference intervention with 3.6 g/d dried cucumber supplements. Research subjects will come to the research facility for a test day on four occasions, with an interval of 4 weeks. The main study parameter is fasting levels of plasma glucose. Secondary outcome measures are glucose tolerance, HbA1c, insulin and HOMA-IR and HOMA-B levels.

Eligibility Criteria:
Inclusion Criteria:

* age 40-75yrs
* BMI \>25 kg/m2
* Having a fasting glucose \>6.1 mmol/L

Exclusion Criteria:

* Use of medication/supplements that may influence the study results, such as metformin, gliclazide, glimepiride, tolbutamide, insulin, sitagliptin (DPP4 inhibitor), liraglutide (GLP-1 agonist), acarbose, repaglinide, pioglitazone, corticosteroids (systemically) , SGLT-2 inhibitors, (judged by our research physician)
* Having a fasting glucose \>11.0 mmol/L
* History of gastro-intestinal surgery or having (serious) gastro-intestinal complaints
* History of liver dysfunction (cirrhosis, hepatitis) or liver surgery
* Reported slimming, medically prescribed or other extreme diets
* Reported weight loss or weight gain of \> 5 kg in the month prior to pre-study screening
* Not willing to give up blood donation during the study
* Current smokers
* Alcohol intake ≥14 glasses (women) or \>21 glasses (men) of alcoholic beverages per week, on average
* pregnant or lactating (self-reported)
* Abuse of illicit drugs (soft- and hard drugs)
* Food allergies for products that we use in the study
* Participation in another clinical trial at the same time
* Being an employee of the Food, Health \& Consumer Research group of Wageningen Food \& Biobased Research or dept. human nutrition and health of Wageningen University.
Study Evaluating TMI-005 in Active Rheumatoid Arthritis

The primary objective of this clinical research study is to compare the efficacy and the safety of 3 dose levels of oral TMI-005 in comparison with placebo in subjects with active Rheumatoid Arthritis (RA) who have been receiving stable doses of Methotrexate (MTX).


Eligibility Criteria:
Inclusion Criteria:

* Meet American College of Rheumatology (ACR) criteria for RA
* Have active RA
* Disease duration of at least 6 months
* Disease onset at \> 16 years of age.

Exclusion Criteria:

* Any prior use of anti-TNF alpha biologics, rituximab, receipt of anti-CD4 or diphtheria interleukin-2 fusion protein or other immunosuppressive biologics (except for anakinra)
* Largely or wholly incapacitated with the subject bedridden or confined to a wheelchair, permitting limited or no self-care
* Pregnant or breastfeeding women or women planning to become pregnant during the study or within 12 weeks after the last dose of test article
A Prospective, Clinical Investigation of the Vanguard 360 Revision Knee

The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

This investigation is being conducted on a new complete revision knee system, Vanguard 360, which incorporates:

* Fixed Bearing Knee - Vanguard SSK360 with PS Bearing and PSC Bearing
* Fixed Bearing Knee - Vanguard SSK360 TiNbN Femur with PS Bearing and PSC Bearing
* Mobile Bearing Knee - Vanguard DA360 (only being collected in Europe)

The purpose of this study is to evaluate performance of the Vanguard 360 revision knee system utilizing offset on either the tibial component, femoral component, or both in terms of the restoration of mechanical alignment, clinical outcomes and survivorship.

The efficacy and performance of the devices will be assessed by improvement of pain, function, range of motion and patient satisfaction measured pre-operatively and post-operatively. Secondary performance and safety will be determined by radiographic investigation, incidence of complications and revision rates.

Surgical techniques and patient care are to be standard for the surgeon participating in the protocol. There will be no experimental or investigational devices used. There will be no experimental or investigational surgical techniques used. The devices and products will be used in accordance with their instructions for use and/or approved labeling.

Eligibility Criteria:
Inclusion Criteria:

* Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved.
* Correction of varus, valgus or post-traumatic deformity
* Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure
* Ability and willingness of the patient to attend follow-up visit.
* Willing to give written informed consent
* Patients are at least 18 years of age, no upper age limit, must have reached full skeletal maturity.

Exclusion Criteria:

* infection
* sepsis
* osteomyelitis

Relative Contraindications:

* An uncooperative patient or a patient with neurologic disorders who is incapable of following directions
* Osteoporosis
* Metabolic disorders which may impair brain function
* Osteomalacia
* Distant foci of infections which may spread to the implant site
* Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram
* Vascular insufficiency, muscular atrophy, neuromuscular disease
* Incomplete or deficient soft tissue surrounding the knee

Additional research-related exclusion criteria: patients who have a history of or current infection in the affected knee.
Improvement of RARP Outcomes Via 3D Printed/Virtual Prostate Models

Study the effect 3D printed or 3D virtual prostate models of a patient, when manipulated by surgeons during RARP, has on positive surgical margins and functional outcomes of patients. Our main hypothesis is that there is a reduction of positive resection margins and functional outcomes of patients undergoing RARP when surgeons are presented with 3D printed or 3D virtual patient-specific prostate models during surgery. Specifically, we hypothesize that the anatomical knowledge of surgeons that results from the manipulation of 3D printed/virtual models constructed from automated segmentations reduces positive resection margins and functional outcomes.

This is a parallel group research feasibility study consisting of two intervention arms (3D printed and 3D virtual models) and a control group (standard practice). Intervention groups are prospective; control group is retrospective. Prospective patients, complying with the inclusion criteria, will randomly be allocated to only one intervention group.

Primary outcomes Study the effect of two-intervention arms (3D printed and virtual prostate models) have on the improvement of positive resection margins after RARP, validate the accuracy of automated methods when identifying masks of the prostate gland and, cancer lesions urethra, neurovascular bundles, and external sphincter, and validate the effectiveness of an automated deployment pipeline with the goal of setting groundwork in preparation for a randomise control trial in a subsequent study.

Secondary outcomes Study the effect of two-intervention arms have on functional outcomes, surgeons' and patients' perspectives on using 3D prostate models.

A total of 162 cases will be considered in this feasibility study stratified into 3 cohorts:

* Control group. The control group will consist of 54 retrospective case-matched dataset whereby mp-MRI, positive resection margins, and functional outcomes will be collected and used as a baseline. Automated segmentation of prostate gland and lesions will be done on mp-MRI.
* Intervention arm 1 - 3D printed models. This cohort will consist of 54 prospective cases whereby patient-specific 3D printed models will be available to the surgeon during RARP for manipulation.
* Intervention arm 2 - 3D virtual models. This cohort will consist of 54 prospective cases whereby 3D virtual models will be available to the surgeon during RARP for manipulation using Innersight Labs platform.

Eligibility Criteria:
Inclusion Criteria:

* Eligible for RARP after assessment of mp-MRI during multi-disciplinary team meetings at Guy's Hospital
* T2b-T3 prostate cancer patients
* Gleason's score\>=3+4 .

Exclusion Criteria:

* prior treatment for prostate cancer
* patients with pre-existing urinary incontinence problems
* patients where mp-MRI scans are not possible
* patients participating in other studies investigating functional outcomes after surgery will be excluded. This is to avoid other studies influencing our secondary endpoints.
Effects of Ashtanga-Vinyasa Yoga Supta on Portuguese Airforce Military Pilots Performance

A total of 18 military pilots in their tirocinium in the air force academy from the Portuguese Air Force course "Masters in Military Aeronautics: aviator pilot specialist" participated in this study. Participants were randomly assigned to yoga (intervention group) or waiting list (control group). Procedures were approved by the Évora University research ethics committee and participants will give written informed consent according to the Helsinki declaration (approval number: 21050).

A randomized, prospective, controlled trial was designed, with the participants (n=18) randomly distributed into two groups. The Control Group (n=8) will be receiving the protocolized classes from the course "Masters in Military Aeronautics: aviator pilot specialist" for 12 weeks, the Intervention Group (n=10) will receive the same course and 2 sessions per week (1h each) of the yoga classes (4). The intensity of the program (Borg rating of perceived exertion scale) will be measured. The operative performance response measurements will be collected at baseline and post-intervention. Participants will complete the following emergency protocols in a flight simulator: (1) take-off engine failure, (2) flight engine failure close to the base, (3) flight engine failure far away from the base, and (4) alternator failure. This intervention protocol was accepted by the Portuguese Airforce to be applied on Airbase 11 in Beja.

Eligibility Criteria:
Inclusion Criteria:

* healthy military pilots in their tirocinium in the air force academy from the Portuguese Air Force course "Masters in Military Aeronautics: aviator pilot specialist

Exclusion Criteria:

* military pilots on active duty before or after the tirocinium;
* injured military pilots;
* military pilots on sudden lifestyle changes (as in: starting or quitting smoking habits; starting or quitting any kind of medication; starting a new diet)
A Multi-Center, Prospective, Observational Study of Patients Being Treated with ORGOVYX

This is a multi-center, prospective, observational study of patients being treated with ORGOVYX. The goal of this study is to generate real-world evidence about the safety and effectiveness of ORGOVYX in patients with prostate cancer in routine clinical care and the clinical course during treatment with and following cessation of ORGOVYX.

This prospective observational cohort study will be conducted in patients who are initiating treatment or have initiated treatment with ORGOVYX within the 1 month prior to the time of study enrollment and who remain on treatment at the time of enrollment. The decision to initiate treatment with ORGOVYX should be made prior to study enrollment. The study is designed to better understand the actual experience of patients with prostate cancer treated with ORGOVYX by collecting data on treatment patterns, adherence, and selective safety data. Additionally, a better understanding of the trajectory of patients with prostate cancer following cessation of ORGOVYX therapy will be gained by observing the clinical course of the disease, health outcomes, and health-related quality-of-life (HRQoL) in these patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients who are diagnosed with prostate cancer and initiating treatment with ORGOVYX at the time of enrollment or within 1 month prior to enrollment and who remain on treatment at enrollment
* Patients who are willing and able to complete PRO assessments during the study
* Patients who have reviewed and signed the informed consent form (ICF)

Exclusion Criteria:

* Patients with a history of surgical castration
* Patients with a medical or psychiatric condition that precludes participation in the opinion of the treating physician
* Patients whose original treatment plan is intended to be less than a total of 4 months of ORGOVYX
COVID-19 Pandemic on Health Care and Rehabilitation Outcomes

Fragility fracture is easily associated with a clinical worsening of patients in terms of quality of life and disability in the medium and long term. Following this traumatic event, more than half of the patients are unable to recover pre-fracture motor skills such as the ability to walk. The impact of the COVID-19 pandemic on this type of patient has not been described and it is easy to hypothesize that, given their intrinsic frailty condition, they may have been significantly affected by changes in care pathways.

The global health emergency due to the spread of COVID-19 has caused unprecedented pressure on the health systems of the various countries involved. COVID-19 has had a direct impact on the health status of people with an extremely high number of ICU admissions and deaths, but it has also led to a series of equally strong indirect consequences as described in various fields by multiple authors. In order to cope with the great health demand linked to the epidemic, hospitals had to invest human and physical resources, subtracting them from other care activities: operating theaters, surgical and non-surgical departments and the related staff normally destined for patient care were redirected and relocated to the care of COVID patients.

In the field of orthopedic surgery in the first phase of the spread of the epidemic, all non-essential interventions have been postponed and for essential interventions specific paths have been created at hospitals capable of operating even during the pandemic. This organization has led to a reduction in the overall number of hospitalized patients but the number of old patients operated for hip fracture has not decreased. From the point of view of the impact of the COVID-19 pandemic on all patients operated for hip fracture with respect to the care outcomes during the postoperative hospital stay, the available data are lacking.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with fragility hip fracture such as pertrochanteric fracture, femoral neck fracture and subtrochanteric fracture
* Age 65 or older

Exclusion Criteria:

* Patients diagnosed with a fragility hip fracture whose nursing record was not scanned at the time of the investigation
* Patients with fragility fractures of the diaphyseal and / or distal femur and acetabular fractures.
Intergenerational Transmission of Terror

Our aim is examine avenues by which mothers can transmit their trauma to their children.

The goal of the study is to test for genetic bases and Gene x Environment interactions on the development of difficulties, particularly stress disorders, in young children whose mother were exposed to terror before they were born.

Eligibility Criteria:
Inclusion Criteria:

* Pregnant women who were exposed to terror in the last 5 years
* Matched Controls

Exclusion Criteria:

* Does not speak Hebrew or English
Impact of Sarcopenia on Dyspnea in Patients with Asthma

Dyspnea in asthma, is mainly due to airway obstruction but can be caused by several alternative diagnoses.

The impact of sarcopenia on dyspnea in patients with asthma is unknown. Sarcopenic asthma had a reduced physical activity and is associated with airway obstruction compared to non-sarcopenic asthma. In patients with obstructive pulmonary disease, sarcopenia is associated with shallow breathing and diverse sensory and affective components of exertional dyspnea .

The morbidity of sarcopenia is also increased by systemic inflammation and the production of inflammatory cytokines as found in inflammatory airway obstruction.

The investigators will investigate the prevalence and impact of sarcopenia in asthmatics patients. This will enable to better manage sarcopenia in asthmatic patients, understand its origins and personalize treatment.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Patient affiliated to a social security scheme.
* Patient capable of giving free, informed, written and signed consent.
* Asthmatic patients with a diagnosis made by a pulmonologist on GINA level 4 or 5 treatment
* ACT asthma control score \< 20
* Patient judged by the investigator to be able to to perform a maximal exercise test.

Exclusion Criteria:

* Patient under guardianship/trusteeship/supervision of justice
* Pregnant or breast-feeding women
* Unstable heart disease
* Patients who have been smoking or have stopped smoking for less than 5 years,
OLIGOS: Impact of Treatment on Primary Tumour in Patients With Newly Diagnosed Oligometastatic Neoplasia of the Prostate

The proposed study consists of a multicentre prospective observational study involving patients with oligometastatic prostatic neoplasia defined according to CHAARTED criteria.

The aim of the study is the creation of a registry including patients with newly diagnosed OMPCa, belonging to the main urological centres in the Triveneto region, in order to evaluate the oncological outcomes and the impact on the quality of life of local treatment of the primary neoplasm (surgical or radiotherapy) in addition to systemic hormonal treatment (ADT as monotherapy or in combination with Docetaxel/androgen receptor signal inhibitors (ARTA)).

The above criteria define 'high metastatic volume' disease with the following parameters

* ≥ 4 bone metastases, including at least one outside the spine and pelvis
* Presence of visceral metastases Consequently, patients included in the study should not have the above-mentioned characteristics.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of new-onset prostate neoplasia (any risk category according to EAU guidelines).
* Histological confirmation of disease by prostate biopsies. Absence of neuroendocrine differentiation
* Low volume of metastatic disease defined according to CHAARTED study criteria (\< of 4 bone metastases, absence of visceral metastases)
* Patients without previous treatment of primary malignancy (e.g. previous radical prostatectomy, previous RT)
* Patients treated with systemic therapy (ADT as monotherapy or in combination) for less than 6 months prior to enrolment
* Eastern Cooperative Oncology Group (ECOG) performance status 0-1
* Patients eligible for local treatment of primary malignancy and concomitant systemic therapy
* Signature of informed consent

Exclusion Criteria:

* Inability or unwillingness to give written informed consent
* High volume metastatic disease defined according to CHARTEED criteria
* ECOG performance status \> 1
* Patients included in other clinical trials
* Contraindications to hormone/systemic therapy administration
* Previous treatment of primary tumour (RP, RT or other treatment of primary tumour)