cyrilzakka/clinical-trials huggingface dataset:
The Effect of ScopeGuide on the Mental Workload of Endoscopist

ScopeGuide (Magnetic endoscopic imaging) is a device used during some colonoscopies which provides real-time 3D image of the shape and configuration of the colonoscope as it travels through the colon. Whilst it is being used in clinical practice in most units in the UK, it is not a device which is routinely used on all lists, and most departments do not own enough ScopeGuides to have on all lists. Studies have shown it can potentially aid colonoscopy by improving completion rates and times as well as patient comfort in selected endoscopists (persons who perform the colonoscopy). However data on its benefit have been conflicting.

Subjective mental workload (the individuals mental resources required as a result of the multiple demands placed on him/her from a task)in healthcare employees is known to be important for the performance and safety of healthcare delivery. Increased workload during task performance may increase fatigue, facilitate errors and lead to overall inferior performance.

In colonoscopy high mental workload could potentially be responsible for longer procedural time, lack of trainee learning, inadvertent missing of lesions in the bowel as well as poor technique leading to patient discomfort. The effect of the endoscopist mental workload on their performance and potential facilitators to reduce mental workload is an area that has been neglected in this field.

This study aims to look at the mental workload of endoscopist during colonoscopy and the effect ScopeGuide may have on this workload.

Hypothesis: The use of ScopeGuide during colonoscopy will reduce the mental workload of the endoscopist performing the procedure


Eligibility Criteria:
Inclusion Criteria:

* All endoscopist performing colonoscopy at University hospital Southampton endoscopy unit
* All adult patients attending diagnostic colonoscopy

Exclusion Criteria:

* Endoscopist preference
* Patients unable to give informed consent
* Patient preference
* Patients with new diagnosis of colonic cancer
A Prospective Trial of Virtual Home Rehabilitation After Burn Injury

The overarching goal for this prospective randomized controlled trial (PRCT) is to determine whether a virtual-environment, home-rehabilitation program improves functional outcomes for individuals after a burn injury. Specifically, this study will test the efficacy of a technology-assisted rehabilitation program against current standard of home therapy.

This is a prospective, randomized controlled trial (PRCT) involving 50 adult burn survivors. This study tests the efficacy of a technology-assisted rehabilitation program against current standard of home therapy. There are two study groups for which subjects will be randomized: control and experimental.The control group will receive treatment as usual, which includes a personalized home exercise program prescribed by a burn therapist, prior to hospital discharge. The experimental group receives treatment as usual, in addition to training and use of the Jintronix platform for 3 months after hospital discharge. Participants will undergo their prescribed therapy regimen for 3 months, with outcomes follow-up to 12 months post-discharge.

Eligibility Criteria:
Inclusion Criteria:

* Age greater than or equal to 18 years old (no upper age limit)
* Ability to provide written, informed consent for study participation
* Ability to read and understand English
* Anticipated discharge to home environment
* Home environment includes access to:

  * television (larger than 20 inches in diameter with High Definition Multimedia Interface input (HDMI)
  * internet and email address
  * telephone (cell phone or landline)

Exclusion Criteria:

* Age less than 18 years
* Inability to provide written, informed consent for study participation
* Inability to read or understand English
* Delirium (as determined by the Delirium Observation Score test)
* Near-fall event at time of screening
* Pregnant women
* Discharge to non-home environment (e.g., shelter, street, skilled nursing facility)
ZeroFall - Reliability Testing of Optical Sensor to Detect Bed Exit for Patients in Hospital

Falls are one of the most common NHS adverse events. With an increasing number of frail elderly patients being admitted this risk is likely to increase. In order to be able to assist patients with bed exit in a timely manner monitoring might be of help. In ZeroFall we will test the reliability of monitoring devices to notify care givers if a patient is attempting to exit the bed.

In ZeroFall we intend to observe patients on risk of fall with two different devices during their hospital stay: The information from a no-touch optical sensing device that analyses movement and an under the mattress sensor that has already been used in a previous study at Bangor. Both are compatible with an existing monitoring system by Philips Healthcare and CE marked.

Eligibility Criteria:
Inclusion Criteria:

Adult patients with risk of fall more than 24 hours on the ward

Exclusion Criteria:

Patients with predominantly palliative needs
Postoperative CRP Levels and Vaginal Cuff Hematoma

After laparoscopic hysterectomy, authors aimed to determine cuff hematoma and a postoperative CRP value to help predict the other complications.

A total of 136 patients who underwent total laparoscopic hysterectomy (TLH) were evaluated. CRP, White blood cell (WBC) and hemoglobin values (Hb) were measured on the 1st, 2nd and 7th days before and after the operation. Complications, pre-postoperative vaginal length and female sexual function were evaluated. Fourteen patients who developed cuff hematoma during postoperative follow-up were analyzed with the receiver operating characteristics (ROC) curve. ROC curves with the largest area under the curve for each inflammatory marker were compared in order to define the marker with higher diagnostic accuracy.


Eligibility Criteria:
Inclusion Criteria:women who underwent TLH operation with benign gynecological indications

Exclusion Criteria:

* Decided to switch to laparotomy during operation
* postoperative complication due to relaparotomy
* infection (including urinary system and lung infections)
* Blood transfusion after TLH
* with rheumatic diseases
* length of hospital stay due to wound infection
Study of Exercise and Heart Function in Patients With Heart Failure and Pulmonary Vascular Disease

Heart Failure with Preserved Ejection Fraction (HFpEF) and Pulmonary Hypertension (PH) can be diagnosed noninvasively by Exercise Echocardiography (ExE) and Cardiopulmonary Exercise Testing (CPX) as compared with gold standard invasive hemodynamic assessment.

* The broad objective of this proposal is to characterize the dynamic changes in cardiopulmonary mechanics during stress in patients with exertional dyspnea, establishing a comprehensive multimodality diagnostic approach to the evaluation of exercise intolerance.
* The specific objective is to prospectively compare established and novel parameters derived from echocardiography and CPX with simultaneous, gold standard invasive measures of cardiovascular hemodynamics at rest and with exercise stress to define the role of noninvasive testing in the diagnostic workup.
* The primary hypothesis is that combined ExE and CPX can noninvasively identify HFpEF.

Eligibility Criteria:
Inclusion Criteria:

* exertional intolerance/dyspnea of unknown etiology
* referral to cardiac catheterization laboratory
* undergoing invasive hemodynamic evaluation for clinical purposes

Exclusion Criteria:

* hypertrophic cardiomyopathy
* constrictive pericarditis
* infiltrative myopathy (e.g. amyloid)
* congenital heart disease
* resting LVEF \<50%
* \> moderate mitral annular calcification
* moderate or greater left-sided valvular stenosis or regurgitation
* prior valve surgery
* basal septal wall motion abnormalities
* \>70% epicardial coronary artery stenosis
* right ventricular infarction
* pregnancy
Effects of Soft Tissue Lengthening on Gait in Children With Spasticity

This research project is being conducted to investigate changes in secondary impairments, functional mobility skills, and gait variables in children with spasticity following selective percutaneous myofascial lengthening. The research project proposed here will be the first to use instrumented three-dimensional motion analysis to investigate the effects of selective percutaneous myofascial lengthening on gait kinematics and kinetics. The objectives of the study are to:

1. Compare gait kinematics and kinetics in children and young adults with lower extremity spasticity before and after selective percutaneous myofascial lengthening to determine the effects of this procedure on functional mobility.
2. Identify changes in impairments and activity limitations following selective percutaneous myofascial lengthening .
3. Identify changes in a family or caregivers perceived quality of life after their child's selective percutaneous myofascial lengthening .

The aim of this study is to identify and describe the specific changes in secondary musculoskeletal impairments, activity limitations, and gait kinematics and kinetics after a selective percutaneous myofascial lengthening procedure. Gait kinematics and kinetics includes the motion of joints and body segments, and force and power, at each lower extremity joint, respectively. The results of this study will provide preliminary information on how this form of soft tissue lengthening affects functional mobility skills in children with spasticity. The study is expected to run for two years and the primary study endpoint is when participants have completed their second post- operative data collection session.


Eligibility Criteria:
Inclusion Criteria:

* Scheduled for an selective percutaneous myofascial lengthening procedure,
* Between the ages of 4.0 and 20.11 years old,
* Lower extremity spasticity,
* Able to ambulate 50 feet without a rest, with or without an assistive device, and with or without ankle foot orthoses (AFOs) and
* Able to follow one step directions.

Exclusion Criteria:

* Botox injections into any lower extremity muscle within three months of the scheduled selective percutaneous myofascial lengthening procedure,
* Lower extremity orthopedic surgery within 6 months of the scheduled selective percutaneous myofascial lengthening procedure,
* Visual impairment that interferes with maintaining a straight path while ambulating,
* Uncontrolled seizure disorder
* A change in medication that affects spasticity or ability to follow one step directions within three months of the scheduled selective percutaneous myofascial lengthening procedure.
Strep A Fluorescent Immunoassay and Analyzer Field Study

The purpose of this study is to demonstrate the ability of the Strep A Fluorescent Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence of Strep A when compared to culture.


Eligibility Criteria:
Inclusion Criteria:

* Male and female subjects three (3) years of age or older

Must currently be exhibiting one or more of the following symptoms characteristic of pharyngitis

* Extreme sore throat
* Redness of the posterior pharyngeal wall
* Difficulty Swallowing
* Fever, \>38.7C (100F) at presentation or within past 24 hours
* Pharyngeal exudate
* Tender cervical lymphadenopathy
* Absence of cough or other upper respiratory symptoms

Exclusion Criteria:

* Subjects currently under treatment with antibiotics are not to be included in this study.
* At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
RESET-MG: A Study to Evaluate the Safety and Efficacy of CABA-201 in Participants With Generalized Myasthenia Gravis

RESET-MG: A Phase 1/2 Open-Label Study to Evaluate the Safety and Efficacy of CABA-201 in Participants with Generalized Myasthenia Gravis

Myasthenia gravis (MG) is a rare autoimmune disorder characterized by autoantibody responses that cause defective transmission of signals at the neuromuscular junction, resulting in a distinctive pattern of weakness. Patients with generalized MG (gMG) typically experience symptoms associated with ocular disease in addition to weakness of many other voluntary muscle groups, including extremity, bulbar, and respiratory muscles. MG is considered a classic example of a B-cell mediated autoimmune disease. Currently, there are no curative treatments for MG. This study is being conducted to evaluate the safety and efficacy of an investigational cell therapy, CABA-201, that can be given to patients with gMG. A single dose of CABA-201 in combination with cyclophosphamide (CY) and fludarabine (FLU) will be evaluated.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 and ≤70 years of age
* Diagnosis of MG with generalized muscle weakness meeting criteria as defined by the MGFA class II, III , IVa, and IVb.
* Diagnosis of seropositive (autoantibodies AChR, MuSK and/or LRP4) or seronegative MG

Exclusion Criteria:

* Contraindication to leukapheresis
* History of anaphylactic or severe systemic reaction to fludarabine, cyclophosphamide or any of their metabolites
* Active infection requiring medical intervention at screening
* Current symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, pulmonary, psychiatric, cardiac, neurological, or cerebral disease, including severe and uncontrolled infections, such as sepsis and opportunistic infections.
* Concomitant medical conditions that, in the opinion of the investigator, might place the subject at unacceptable risk for participation in this study, interfere with the assessment of the effects or safety of the investigational product or with the study procedures
* Significant lung or cardiac impairment
* Prior solid organ (heart, liver, kidney, lung) transplant or hematopoietic cell transplant

Other protocol-defined inclusion/exclusion criteria may apply.
Effect Of Single-Dose PF-05175157 On Metabolic And Cardiopulmonary Parameters

This study is designed to assess the effect of one single dose of PF-05175157 on metabolic and cardiopulmonary parameters before, during and after treadmill exercise in healthy volunteers.


Eligibility Criteria:
Inclusion Criteria:

* Healthy male and/or female subjects of non child bearing potential only, between the ages of 18 and 40 years, inclusive (Healthy is defined as no clinically relevant abnormalities identified by a detailed medical history, full physical examination, including blood pressure and pulse rate measurement, 12 lead ECG and clinical laboratory tests).
* Body Mass Index (BMI) of 18 to 28 kg/m2; and a total body weight \>50 kg (110 lbs).
* Subjects with maximum effort studies (peak RER \>1.05) and normal exercise capacity as defined by peak VO2 ≥80% and ≤120% of predicted and no evidence of inducible ischemia or significant arrhythmia at the time of peak aerobic capacity testing 3 (±1) days prior to initiation of the study.

Exclusion Criteria:

* Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease (including drug allergies, but excluding untreated, asymptomatic, seasonal allergies at time of dosing).
* History of smoking in the past 5 years or history or evidence of habitual use of other (non smoked) tobacco or nicotine-containing products within 3 months of Screening or positive cotinine test at Screening or Day -3 (±1).
* Dry eye symptoms
Efficacy Study of Intra-articular Hyaluronic Acid in the Knee Osteoarthritis

The purpose of this study is to prove the non-inferiority of the intra-articular injection of hyaluronic acid (Sinovial®) in the symptomatic treatment of knee OA in comparison to Synvisc®.


Eligibility Criteria:
Inclusion Criteria:

* Age between 40 and 80 years
* Primary knee OA of the medial or lateral femoro-tibial compartment
* Symptoms for at least 3 months
* Diagnosis according to ACR criteria
* Kellgren \& Lawrence radiological grade 2-3
* Patients who failed to respond sufficiently (not responders) to analgesics and/or NSAIDs taken regularly or responders intolerant to the regular use of analgesics and/or NSAIDs.
* Mean WOMAC pain subscore at the target knee \>= 40 mm and \< 80 mm on a VAS at baseline after wash-out from analgesics/NSAIDs· If bilateral knee OA: definition of the most symptomatic joint at screening based on patient's evaluation and Investigator's clinical judgment and mean WOMAC pain subscore at baseline in the contra-lateral knee \< 30 mm
* Written informed consent
* Subject able to understand, co-operative and reliable

Exclusion Criteria:

* BMI \>= 32 kg/m2
* Secondary (post-traumatic) knee OA
* Predominantly patello-femoral pain/syndrome
* No remaining joint space width
* Symptomatic hip OA or other interfering health condition
* Severe varus/valgus deformity (\>15°)
* History/present evidence of (target knee): inflammatory, infective or metabolic joint diseases; recurrent clinical chondrocalcinosis; crystal arthropaties; osteo-articular pathologies differing from arthrosis; articular fracture; ochronosis; acromegaly; haemochromatosis; Wilson's disease; primary osteochondromatosis; heritable disorders; collagen gene mutations.
* Concomitant rheumatic disease
* Significant injury to the target knee in the last 6 months
* Previous joint replacement/arthroplasty (target knee)
* Arthroscopy/osteotomy/surgery in the past 1 year (target knee)
* Any surgery scheduled in the next 6 months
* Venous or lymphatic stasis in the relevant limb
* Skin infection/disease/trauma at the injection site
* Systemic or i.a. (target knee) corticosteroids in the past 3 months
* I.a. corticosteroids (non-target joint) in the past 4 weeks
* Viscosupplementation (target knee) in the past year
* Recently started (in the last 3 months) physical therapy (target knee)
* Recently (in the last 3 months) started therapy or change in dosage of SYSADOAs
* Ongoing anticoagulant therapy
* Chronic or recurrent use of NSAIDs/analgesics/narcotics because of diseases different from OA of the target knee
* History of allergy or hypersensitivity to hyaluronic acid or paracetamol or avian proteins
* Participation in a clinical study in the last 3 months
* Pregnant or lactating women, and women of childbearing potential not willing to use adequate contraception
* Patients unable to stay in the study for 6 months, non-cooperating, not able to understand
A Post-market Observational ORIGIN® CR Clinical Study

The study objective is to evaluate safety and performance of the ORIGIN® CR (cruciate retaining) devices and associated instruments, more precisely to evaluate safety by the proportion of patients requiring a revision (i.e. revision rate) at 1-year post procedure and to evaluate performance by means of a Knee Society Score (KSS) Knee Score at 1 year post procedure and by means of a KSS Function Score also at 1 year post procedure.

The hypothesis raised for this study, regarding the scoring, is that patients will experience a marked improvement in the natural feel of the prosthesis during the first year after the surgery, and slightly significant improvement at the following interval of 2 years. The overall patient satisfaction is expected to be improved after 2 years follow-up with ORIGIN® CR.

The study is a prospective, non-comparative, non-randomized, single-arm, observational, post market study in which 199 patients will be enrolled to evaluate the safety and performance of the ORIGIN® CR devices and associated instruments.

Patients will be included in the study during 18 months (inclusion window) and followed-up for 24 months.

Eligibility Criteria:
Inclusion Criteria:

* Male and female over 18 years of age
* Each patient who is willing to give informed consent.
* Clinically indicated for a total knee replacement
* Females who are not pregnant and not planning to become pregnant ≤ 12 months. A pregnancy test should be performed for women of childbearing age
* Geographically stable and willing to return to the implanting site for all follow-up visits at 1 year and 2 years.

Exclusion Criteria:

* Acute or chronic, local or systemic infection
* Muscular, ligamental, neurological, psychological or vascular deficits
* Bone destruction or poor bone quality likely to affect implant stability (requiring a femoral and/or a tibial stem and/or a thick insert)
* Any concomitant condition likely to affect implant integration or function
* Allergy or hypersensitivity to any of the materials used
* For devices in CoCrMo (ISO 5832/4): renal and hepatic impairment
* Hip Knee Ankle (HKA) angle \< 165° or \> 195°
* Severe collateral ligaments deficiency (requiring a more constrained prosthesis)
* Posterior cruciate ligament deficiency
* Major anatomical deformities
* Severe flexion contracture or severe recurvatum
* Revision of a partial or total knee prosthesis
* Non-extractible material (e.g. screws, plate, intramedullary nail, osteosynthesis material...) which can create a conflict with any component of the prosthesis
* Distal and/or posterior and/or anterior femoral bone loss which exceeds the femoral component thickness
* Proximal tibial bone loss which exceeds the tibial component thickness (tibial tray + tibial insert)
* Bone degradation requiring an anchoring stem for femoral component
Enoxaparin Versus Unfractionated Heparin in PCI

Enoxaparin 0.75mg/kg BW is not inferior to weight adjusted unfractionated heparin as anticoagulation for PCI


Eligibility Criteria:
Inclusion Criteria:

* PCI for stable ischemia or ACS

Exclusion Criteria:

* Cardiogenic shock,
* Pretreatment with study drugs,
* Lack of informed consent