cyrilzakka/clinical-trials huggingface dataset:
Clinical Performance of Stenfilcon A Versus Filcon II 3

Clinical Performance of Stenfilcon vs. Filcon II 3

The objective of this study is to compare the comfort and clinical performance of Stenfilcon vs. Filcon II 3 compared to subject's habitual contact lenses. The null hypothesis is that there is no difference in the clinical performance between the two sets of lenses.

Eligibility Criteria:
Inclusion Criteria:

Subjects must satisfy the following conditions prior to inclusion in the study:

* Based on his/her knowledge, must be in good general health. Be of legal age (18 years) or older.
* Be able and willing to adhere to the instructions set forth in this protocol and complete all specified evaluation.
* Read, indicate understanding of, and sign Written Informed Consent (Appendix 1)
* Require a contact lens prescription between -0.50 and -6.00 and have no more than -.75dioptor (D) of astigmatism in both eyes
* Achieve visual acuity of 6/9 or better in each eye with a spherical contact lens prescription.
* An existing soft contact lens wearer of any modality.
* Must be able to wear their lenses at least 6 full days over the 7 days; 14 hours per day, assuming there are no contraindications for doing so.
* Have normal eyes with no evidence of abnormality or disease. For the purposes of this study a normal eye is defined as one having:
* No amblyopia.
* No evidence of lid abnormality or infection (e.g. entropion, ectropion, chalazia, recurrent styes).
* No clinically significant slit lamp findings (e.g. infiltrates or other slit lamp findings greater than Grade 2: corneal edema, tarsal abnormalities, and conjunctival injection).
* No other active ocular disease (e.g. glaucoma, history of recurrent corneal erosions, cornea \[infiltrates\], conjunctiva, lids, and intraocular infection or inflammation of an allergic, bacterial, or viral etiology.)
* No aphakia

Exclusion Criteria:

Any of the following will render a subject ineligible for inclusion:

* Neophytes, who have not worn lenses before
* Greater than 0.75D of refractive astigmatism in either eye
* Presence of clinically significant (grade 3 or above) anterior segment abnormalities; inflammations such as iritis; or any infection of the eye, lids, or associated structures.
* Presence of ocular or systemic disease or need of medication which might interfere with contact lens wear.
* Slit lamp findings that would contraindicate contact lens wear such as:
* Pathological dry eye or associated findings
* Pterygium, pinguecula or corneal scars within the visual axis
* Neovascularization \> 0.75 mm in from the limbus
* Giant papillary conjunctivitis (GPC) Grade 3 or above
* Anterior uveitis or iritis (past or present)
* Seborrheic eczema, seborrheic conjunctivitis
* History of corneal ulcer or fungal infections
* Poor personal hygiene
* A known history of corneal hypoesthesia (reduced corneal sensitivity).
* Contact lens best corrected Snellen visual acuities (VA) worse than 6/9
* Aphakia, Keratoconus or a highly irregular cornea
Dedicated Breast CT for Diagnosis of Breast Cancer

Dedicated breast computed tomography (BCT) is being developed as a new x-ray based tomographic breast imaging method for early breast cancer detection and/or diagnosis. BCT results in isotropic high spatial resolution three-dimensional (3D) images coupled with high contrast resolution. It is hypothesized that BCT imaging used as a replacement of the additional mammographic views during diagnostic work-up will improve the accuracy of clinical standard diagnostic work-up.

Rationale:

Dedicated breast computed tomography (BCT) is being developed as a new x-ray based tomographic breast imaging method for early breast cancer detection and/or diagnosis. BCT results in isotropic high spatial resolution three-dimensional (3D) images coupled with high contrast resolution. It is hypothesized that BCT imaging used as a replacement of the additional mammographic views during diagnostic work-up will improve the accuracy of clinical standard diagnostic work-up.

Objective:

The primary objective of this research project is to determine the improvement in the area under the receiver operating characteristics (ROC) curve of BCT for diagnosis of breast cancer compared to that of the standard diagnostic work-up. As secondary objectives, this analysis will be performed by lesion type (microcalcifications vs. soft tissue lesions).

Study design:

Single arm study with each subject being its own control

Eligibility Criteria:
Inclusion Criteria:

* Women age 50 or older

Initial schema:

- Women who are scheduled to undergo a diagnostic work-up following an abnormal screening mammogram with the suspicious finding NOT located in the axillary tail of the breast This initial inclusion criterion will be used until 85 subjects that result in a Breast Imaging Reporting and Data System (BI-RADS) 1 or 2 after clinical diagnostic work-up are recruited and imaged.

Subsequent schema:

- Women who underwent diagnostic work-up following an abnormal screening mammogram and were assigned a BI-RADS 4 or 5 due to soft tissue lesions (total 120 patients when combined with those from the initial schema), or due to microcalcifications (total 120 patients when combined with those from the initial schema) with the suspicious finding NOT located in the axillary tail of the breast

Each patient can only enroll once in the study.

Exclusion Criteria:

* Women who do not meet the inclusion criteria as described above
* Women with suspected or confirmed pregnancy
* Women who have had bilateral mastectomy
* Women whose suspicious lesion is located in the axillary tail
* Women with prior breast cancer or breast biopsy in the recalled breast in the last 12 months
* Women who are breastfeeding
* Women who are very frail and unable to cooperate
* Women who cannot give informed consent
* Male subjects
Motor Imagery Technique on Lower Limb Function Among Stroke Patients.

To determine the effects of motor imagery technique on lower limb function among stroke patient.

To determine the effects of motor imagery technique on lower limb spasticity among stroke patients.

To determine the effects of motor imagery technique on gait among stroke patients.

To determine the effects of motor imagery technique on quality of life among stroke patients

Stroke affected the functional capacities and the state of health thus altered quality of life.

Eligibility Criteria:
Inclusion Criteria:

* Adult without ADHD by Adult ADHD Self-Report Scale score.
* History of no more than one stroke.
* Lower limb muscles spasticity with the grade 1+ or 2 on modified Ashworth in scale.
* Mini-mental status score more than 25.
* Patients who are less than 6 months post-stroke.
* Modified Rankin scale score is 4.

Exclusion Criteria:

* Lesion of frontal, parietal and basal ganglia
* Excessive spasticity that is score of\>3 on modified Ashworth spasticity scale.
* Any musculoskeletal disorder impeding lower limb function.
* Participating in any experimental rehabilitation or drug studies.
* Bed ridden patient.
* Subjects psychiatric disorder or dementia.
* Any neglect of space on the affected side, or any other neurological disease or auditory or visual.
Effect of Nutritional Supplementation on Pediatric Burn Patients

This study will determine the effect of nutrition supplementation on blood protein levels in pediatric burn patients.


Eligibility Criteria:
Inclusion Criteria:

1. 1-10 years of age
2. Hospital admission within 24 hours post-burn
3. At least 15% TBSA burned to at least 2nd degree and no more than 5% TBSA 4th degree or higher
4. Capable of exclusive oral feeding within 3 days of hospitalization
5. Expected to be hospitalized at least 14 days

Exclusion Criteria:

1. History diabetes or stress-induced hyperglycemia
2. Artificial ventilation
3. Requires parenteral or enteral feeding
4. IV albumin
5. Drug that affects metabolism
6. Receiving Dialysis
7. Acutely impacted or constipated
8. Consumes non-study nutritional supplement
9. Allergy or intolerance to any study product ingredient
10. Participating in non-Abbott approved concomitant trial
Study on Prevention of SARS-CoV-2 Transmission During a Large Indoor Gathering Event

The objective is to demonstrate if there is no increase in the risk of Sars-Cov-2 salivary carriage 7 days after a concert in the group participating in the event compared to a non participating group who stayed at home.

The hypothesis is that a systematic screening of Sars-Cov-2 within the 3 days before the event allows to control the risk of transmission and prevent cluster of transmission during the concert.

Before inclusion, the participants will be able to pre-register to the event via a website. They will get an appointment for an inclusion visit at the Accor Arena (Paris Bercy, France).

During 3 days (from D-3 to D-1), participants with a registration will come to the Accor Arena to have a rapid Sars-Cov-2 antigen test (results in 15 min).

If the test is positive, the participant will be contacted and managed by the medical team in charge of the national strategy for positives cases.

People with a negative test will be included and randomized :

* Two kits with tube for collecting saliva samples (for D0 and D7) will be given to each participant at this visit
* People randomized in the experimental group will receive their concert ticket at a later date.
* At Day 0, people randomized in the experimental group, will come to the Accor Arena with their ticket to participate in the concert. At the entrance, they should give their D0 saliva sampling kit. The people randomized in the control group will stay at home and will send their D0 saliva sample by post mail.
* At Day 7 (±1 day) all the participants must return their D7 saliva sampling kit via post mail

Eligibility Criteria:
Inclusion Criteria:

* aged between 18 and 45 years old
* lack of symptoms or no contact with people with Covid-19 in the last two weeks
* negative antigenic test to Covid-19 in the 3 days before the experiment
* people who declared to have no risk factor to severe form of Covid-19
* people who declared not to live in the same place as someone with these risk factors
* people residing in Ile-de-France area

Exclusion Criteria:

* positive test to Sars-Cov-2 within 3 days before the concert
* people with clinical signs suggesting infectious respiratory disease
* people with severe Covid-19 risk factor
* people living with someone having severe covid-19 risk factor
* not affiliated to social security
* people who cannot remain standing for the time of the experimentation (about 5 hours)
* person under tutorship or curatorship
* pregnant women or not having effective contraception method
* breastfeeding women
"New Perspectives of Adaptation to NIV in ALS"

The purpose of this study is to demonstrate that the adaptation to the Non Invasive Ventilation (NIV) at home is not worse when compared with an adaptation performed in inpatient settings.


Eligibility Criteria:
Inclusion Criteria:

* ALS diagnosis according to the criteria of El Escorial;
* Clinical indication to NIV (nocturnal hypoventilation and respiratory muscle weakness confirmed according to the criteria normally accepted);
* No respiratory infection within 3 months
* Severe disability (ALS-FRS \<31);
* Age \> 18 years;
* The voluntary participation to the Study.

Exclusion Criteria:

-- Previous episodes of pneumothorax;

* Comorbid cardiac and / or renal important
* Severe cognitive impairment;
* Refusal of the patient at the time of Informed Consent.
Epidural-inhalational Versus Epidural-intravenous Anaesthesia on Anti-tumor Immunity in Patients With Cancer Colon

Surgery is the primary treatment for colon cancer. However, the rate of recurrence or metastasis in colon cancer can be as high as 30%, even in stages 1 and 2 . Most colon cancer-related deaths are caused by metastatic disease . Many patients with colon cancer harbour micrometastases and disseminated tumour cells at the time of surgery . Whether the micrometastases develop into clinically significant metastases depends on the immune system's ability to eradicate them.The aim of the study is to declare the effect of epidural-intravenous based anesthetic technique on anti-tumor immunity and in comparison to epidural inhalational based anesthetic technique in patients undergoing open surgical resection of colon cancer.


Eligibility Criteria:
Inclusion Criteria:

* Age 20-70 yrs.
* ASA class I and II
* Elective open surgery for non-metastatic cancer colon stage I,II

Exclusion Criteria:

* Patient refusal
* Known allergy to the study medications
* Patients with compromised immune function ( associated blood diseases, immunosuppressive drugs, chemotherapeutic agents, corticosteroids)
* Contraindications to epidural insertion e.g. infection at insertion site and coagulopathy
A Prospective Radiostereometric Analysis (RSA) and Clinical Evaluation of the Triathlon Tritanium Total Knee Replacement

This study seeks to find out if the tibial and patellar components of the Stryker Triathlon Tritanium primary total knee replacement achieve adequate fixation to the underlying bone.

Primary Hypothesis:

The investigators expect the tibial and patellar components of the Stryker Triathlon Tritanium knee to achieve adequate fixation to the underlying bone.

Secondary Hypotheses:

The investigators expect that there will be no continuous migration between one and two years post-operative in the Triathlon Tritanium components.

The investigators expect to see a correlation between radiolucent lines and migration characteristics using RSA.

The investigators expect that inducible displacement exams taken at 2 years post-operative will be able to distinguish between patients identified by RSA measurements as having inadequate fixation.

The investigators expect to see a significant difference in health status and functional outcomes before and after total knee replacement using the Triathlon Tritanium knee.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic osteoarthritis of the knee indicating surgical intervention
* Scheduled to undergo a total knee arthroplasty
* Patients between the ages of 18 and 80, inclusive
* Patient is a candidate for Triathlon Tritanium cementless knee components implanted in accordance with product labeling

Exclusion Criteria:

* Significant co-morbidity affecting ability to ambulate
* Prior arthroplasty, patellectomy or osteotomy with the affected knee
* Active or prior infection of the affected knee
* Morbid obesity (BMI \> 40)
* Medical condition precluding major surgery
* Severe osteoporosis
* Neuromuscular impairment
* Pregnancy
* Inability to give informed consent
* Inability to return for follow-up visits for a minimum of two years after surgery
* Currently participating in any other surgical intervention study
* Known allergy to metals
* Flexion contracture greater than 15°
* Extension lag greater than 10°
* Tibial subluxation greater than 10 mm on standing AP radiograph
* Lateral or medial collateral ligament instability (\> 10° varus/valgus)
* Leg length discrepancy greater than 10 mm
Evaluation of the Accelerated Traction of Impacted Canines in Terms of Speed and Changes in the Dental Arches

The time required for orthodontic traction of impacted canines after surgical exposure is a particularly troubling clinical problem because it prolongs the orthodontic treatment duration. During traction process, several complications could result in alveolar bone loss, root resorption of the adjacent teeth, ankylosis, discoloration, loss or vitality and gingival recession. Accordingly, and due to the lack of studies concerned with accelerating the traction movement of the impacted canines, we conducted this study to evaluate the effectiveness of some surgical interventions (corticotomy and Piezocision) in increasing the rate of orthodontic traction movement. We also aimed to evaluate dentoalveolar changes associated with the use of such accelerating procedures compared with the conventional traction method.

Adult patients with unilateral palatally impacted canines will be included in this study. One of patient groups will be treated using fixed orthodontic appliances in combination with some accelerated surgical interventions, while the second patient group will be treated using the traditional treatment method. The velocity of traction movement will be assessed in the two groups. The differences between the two groups in terms of the total treatment duration and the traction duration will be evaluated.

Dentoalveolar changes associated with the use of such accelerating procedures will be assessed by several variables studied on cone-beam computed tomography (CBCT) images. In this study, two groups are going to be evaluated: (1) patients treated in the traditional manner, (2) patients will undergo corticotomy-assisted traction of the impacted canines.

Eligibility Criteria:
Inclusion Criteria:

1. Patients aged 18 to 28.
2. Unilateral palatally or mid-alveolar upper impacted canine.
3. The impacted canine crown not exceeding the middle of the lateral incisor root.
4. Absence of root resorption of the lateral incisors.
5. No contact between the canine crown and the lateral incisor root.
6. Individuals not previously receiving orthodontic treatment.
7. No use of any medications that may affect the orthodontic movement.

Exclusion Criteria:

1. Bilateral or buccal canine impaction cases.
2. More than 45-degree angle between the canine's longitudinal axis and the vertical facial plane.
3. Any medical condition that prevents oral surgery.
4. Oral structural abnormality that is inherited or congenital.
The Impact of Rugae Reproduction on Complete Dentures Patients' Satisfaction

The palatal rugae, refer to asymmetrical and irregular elevations of the mucosa located in the anterior third of the palate, on each side of the median palatal raphe and behind the incisive papilla. The lack of the rugae area on the polished areas of the dentures has been suggested to impact phonetics in denture patients. Therefore, the aim of this randomized crossover clinical trial was to compare patients' reported satisfaction with their complete dentures and oral health related quality of life, when provided with a denture with a reproduction of their rugae on the anterior palatal area as opposed to a polished palatal surface.

The use of dentures could impact the patients' phonetics which could impact their speech. Phonetics could be affected by multiple factors such as having a proper occlusal vertical dimension, proper occlusal plane, correctly positioned anterior and posterior teeth, and adequate contouring of the palatal surface. The lack of the rugae area on the polished areas of the dentures has been also suggested to impact phonetics in denture patients.

The palatal rugae, refer to asymmetrical and irregular elevations of the mucosa located in the anterior third of the palate, on each side of the median palatal raphe and behind the incisive papilla. In addition to enhancing phonetics, the precise reproduction of the rugae in the complete dentures has been suggested to enhance mastication, deglutition and better taste perception. However, these suggestions were based on empirical evidence.

Many studies have described methods for replicating the patients rague on complete dentures, however there are no clinical study to ascertain or negate the impact of this procedure. Therefore, the aim of this randomized crossover clinical trial was to compare patients' reported satisfaction with their complete dentures and oral health related quality of life, when provided with a denture with a reproduction of their rugae on the anterior palatal area as opposed to a polished palatal surface. The null hypothesis was that there would be no difference in patients' reported satisfaction rate using visual analogue scale (VAS) and Oral Health Impact Profile for Edentulous Patients (OHIP-EDENT) Questionnaire response between the two types of palatal contours after using each type for one month post-delivery.

Eligibility Criteria:
Inclusion Criteria:

* Patients seeking a set of conventional maxillary and mandibular complete dentures at the University of Jordan Hospital, for the first time or as a replacement of their previous dentures.
* Patients aged between 45 and 80 years old.
* Patients had been completely edentulous for at least 3 months
* Patients without severe underlying medical conditions, neuromascular dysfunction, auditory problems, mental conditions, oral pathology, xerostomia, or tied tongue condition.
* Patients who approved and consented to participation.
Clinical Evaluation of Fortilink® TETRAfuse® Interbody Fusion Device in Subjects With Degenerative Disc Disease

This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.

This is a prospective, multi-center, non-randomized post-market evaluation designed to collect and evaluate data on the safety and performance of the Fortilink IBF System with TETRAfuse 3D Technology.

There will be 3 arms in the study, one for each configuration of the Fortilink IBF system (Fortilink-C, Fortilink-TS and Fortilink-L). Up to 50 subjects will be enrolled in each study arm for a total of up to 150 subjects at up to 20 sites in the United States (US) and European Union (EU).

Eligibility Criteria:
Inclusion Criteria:

* The subject is skeletally mature and at least 18 years of age.
* The subject has degenerative disc disease (DDD) of the cervical spine with accompanying radicular symptom at one or two contiguous levels (Fortilink-C), or the subject has DDD and ≤ Grade 1 spondylolisthesis of the lumbar spine at one or two contiguous levels (Fortilink-TS and Fortilink-L).
* Subject plans to undergo one of the following procedures:

An anterior cervical interbody fusion at one to two continuous levels from C2-C3 to C7-T1 using autogenous or allogenic bone graft and supplemental fixation cleared and indicated for use at the proposed treatment level(s) (Fortilink-C), or

An interbody fusion in the lumbar spine at one to two continuous levels from L1-L2 to L5-S1 using autogenous or allogenic bone graft and supplemental fixation cleared and indicated for use at the proposed treatment level(s) (Fortilink-TS and Fortilink-L).

* The subject has undergone non-operative treatment of at least six weeks (Fortilink-C) or at least six months (Fortilink-TS and Fortilink-L) prior to treatment with the IBF system.
* The subject is willing and able to provide informed consent.
* The subject is willing and able to attend the protocol required follow-up visits and examinations.

Exclusion Criteria:

* The subject has an active infection
* The subject has had prior fusion attempt(s) or is undergoing revision of a previously implanted system at the involved level(s).
* The subject is a worker's compensation case, in active litigation related to the procedure or is a prisoner or ward of the state.
* The subject meets one or more of the contraindications outlined in the IFU.
* The subject is pregnant, nursing, or is planning to become pregnant in the next year.
* The subject has documented evidence of current substance abuse.
* The subject has other concurrent medical condition that, in the opinion of the investigator, does not make the subject a good candidate for the study.