cyrilzakka/clinical-trials huggingface dataset:
Evaluation of Vision Effects of a Cosmetic Tinted Hydrogel Contact Lens

Subjects will wear 2 of 2 study contact lenses for a wearing time of approximately three to four hours at each of the visits in order to take measurements on binocular functional visual performance.


Eligibility Criteria:
Inclusion Criteria:

1. The subject must read, understand, and sign the STATEMENT OF INFORMED CONSENT and receive a fully executed copy of the form.
2. The subject must appear able and willing to adhere to the instructions set forth in this clinical protocol.
3. The subject must be between 35 and 42 years of age (inclusive).
4. The subject's vertex corrected spherical equivalent distance refraction must be in the range of -6.00 Diopters (D) to +4.00 D in each eye.
5. The subject's refractive cylinder must be ≤ 0.75 D in each eye.
6. The subject must have best corrected visual acuity of 20/30 or better in each eye.
7. The subject must be an adapted soft contact lens wearer in both eyes (defined as a minimum of 6 hours of Daily Wear (DW) for a minimum of 1 month prior to the study).
8. The subject must have normal eyes (i.e., no ocular medications or infections of any type).

Exclusion Criteria:

1. Currently pregnant or lactating (subjects who become pregnant during the study will be discontinued).
2. Any ocular or systemic allergies or diseases that may interfere with contact lens wear.
3. Any infectious disease (e.g., hepatitis, tuberculosis) or a contagious immunosuppressive disease (e.g., HIV) by self-report.
4. Clinically significant (grade 3 or 4) corneal edema, corneal vascularization, corneal staining, or any other abnormalities of the cornea which would contraindicate contact lens wear.
5. Clinically significant (grade 3 or 4) tarsal abnormalities or bulbar injection which might interfere with contact lens wear.
6. Any ocular infection.
7. Any previous, or planned, ocular or interocular surgery (e.g., radial keratotomy, photorefractive keratectomy (PRK), laser-assisted in situ keratomileusis (LASIK), etc.)
8. Any corneal distortion resulting from previous hard or rigid gas permeable contact lens wear.
9. Habitual contact lens type is toric, bifocal, in monovision contact lens wear, or is worn as extended wear.
10. Participation in any contact lens or lens care product clinical trial within 30 days prior to study enrollment.
11. Employee of investigational clinic (e.g., Investigator, Coordinator, Technician)
This Study Explores Whether Adding Natural Elements Like Plants and Sunlight to Indoor Gyms Makes Exercise Feel Easier, More Enjoyable, and Improves Performance. By Comparing Workouts in Nature-inspired and Plain Gym Settings, it Aims to Find Better Ways to Design Fitness Spaces in Cities.

The goal of this observational study is to examine whether exercising in a biophilic environment - a space designed to include natural elements like real plants, simulated sunlight, nature sounds, and outdoor views - can improve exercise performance and enjoyment compared to a standard indoor gym environment in male college students age 18-25 who have regularly exercised prior.

The main question it aims to answer is: "Can biophilic design enhance the physical and mental benefits of indoor exercise?"

Researchers will compare the two environments to see if there is any changes in exercise performance and enjoyment for each participant.

Participants will complete a treadmill fitness test in both settings to compare physical outcomes like maximal aerobic capacity, so the maximal amount of oxygen one can use during exercise, as well as perceived effort. After each treadmill test participants will be given surveys where they will be asked to evaluate their mood and enjoyment in that environment.


Eligibility Criteria:
Inclusion Criteria:

* Men between 18 and 25 years

Exclusion Criteria:

* Resting BP greater than 140/90
* Resting HR greater than 100 bpm
* BMI greater than 30 kg/m\^2
* inability to exercise at moderate to vigorous intensities
* major illness/health complication in the past
Classical Ballet Dance as a Recreational Activity for Adults Women

Classical ballet dance has just used therapeutically in recent years and can be a good recreational activity option at occupational therapy. The purpose of this study was to investigate whether participation in classical ballet dance activity for at least 3 months is associated with psychological distress, depression, anxiety, and well-being.

A total of 128 adults participated in the study, sixty-four for Ballet Group (BG) and Control Group (CG). The psychological distress of the participants were evaluated with the Distress Tolerance Scale (DTS), anxiety and depression evaluated with Hospital Anxiety and Depression Scale (HADS), and well-being and quality of life evaluated with the World Health Organization Well-Being Index (WHO-5).

Eligibility Criteria:
Inclusion Criteria:

The ballet group's inclusion criteria

* age between 18 and 65 years,
* weekly attendance at ballet classes for at least 3 months

The control group's inclusion criteria

* age between 18 and 65 years,
* did not participate in any ballet activity.

Exclusion Criteria:(for both groups)

* Being a professional dancer or athlete
* Diagnosed with systemic diseases such as rheumatoid arthritis, diabetes
* Diagnosed with psychiatric disorders such as depression, anxiety
Myocardial Flow Reserve in Severe AS Without Obstructive Coronary Artery Disease

Exertional angina is common symptom in patients with severe aortic stenosis (AS) without obstructive coronary artery disease (CAD). Although reduced myocardial flow reserve is one of the proposed explanations for angina, little is known about the pathophysiology.

This study aimed that adenosine-stress cardiac magnetic resonance can be used for the assessment of myocardial perfusion reserve and suggest the pathophysiology of development of angina in patients with severe AS without obstructive CAD.


Eligibility Criteria:
Inclusion Criteria:

1. severe AS
2. normal LV ejection fraction (EF ≥ 50%)

Exclusion Criteria:

1. age \<18
2. LVEF \< 50% in echocardiography
3. concomitant other valvular disease of moderate or severe severity
4. previous aortic valve replacement
5. symptomatic patients other than chest pain
6. obstructive CAD (\>30% luminal stenosis in at least one coronary artery on coronary angiography)
7. history of myocardial infarction or acute coronary syndrome
8. contraindication to adenosine
9. any absolute contraindication to CMR
10. estimated glomerular filtration rate \<30 mL/min/1.73m2.
Induction of HO-1; a Therapeutic Approach to Reduce Ischaemia Reperfusion Injury (IRI) Following Deceased Donor Renal Transplantation

This is a blinded, placebo-controlled, randomised controlled trial looking at the effects of Heme arginate (HA) on cadaveric renal transplantation. The investigators know that HA can upregulate HO-1, which has been shown to have a protective effect on animal transplants.

The investigators will be giving HA/placebo to participants prior to transplant and repeat again on day 2 post-transplant and compare outcomes.

Patients will be recruited from the East of Scotland transplant waiting list and consent when they arrive in the hospital. The investigators will randomise them to drug or placebo and give the infusion prior to induction for their transplant.

A blood sample will be taken prior to infusion and a renal biopsy will be taken before the graft is implanted. These will be used as baseline values.

Patients will receive standard care from our unit. The investigators will use the routine blood test results (urea and creatinine) to determine the function of the graft.

The investigators will take blood samples 24 hours after infusion of drug/placebo and use this to determine the primary outcome. Blood tests will be taken daily and a renal biopsy taken on day 5 to fulfil secondary objectives.

Eligibility Criteria:
Inclusion Criteria:

* all patients receiving a cadaveric single kidney transplant
* patients on a standard immunosuppressive regime

Exclusion Criteria:

* patients on different immunosuppressives
* patients receiving 3rd or subsequent kidney transplant
* patients are fully anti-coagulated
* patients unable to take Heme Arginate
* patients unable to give informed consent
* patients on combined anti-platelet agents
Comparative Effectiveness of Biologics or Small Molecule Therapies in Inflammatory Bowel Disease (IBD)

The purpose of this study is to assess effectiveness of vedolizumab versus ustekinumab in patients with Crohn's disease and vedolizumab versus tofacitinib in patients with ulcerative colitis, after non-response to anti-tumor necrosis factor (TNF) medications, using data from two existing cohorts.

This study is a secondary analysis using data from participants in the IBD Partners and SPARC-IBD cohorts. Data received from IBD Partners consists of patient-reported outcomes gathered via online surveys (baseline and 6-month follow-ups). Data received from SPARC-IBD consists of patient-reported outcomes gathered via surveys (baseline and follow-ups) as well as data from clinical records.

Eligibility Criteria:
Inclusion Criteria:

* age greater than or equal to 18;
* diagnosis of CD or UC (as reported by participant for IBD Partners registry and/or physician for SPARC-IBD cohort);
* initiated vedolizumab or ustekinumab for CD, or initiated vedolizumab or tofacitinib for UC; treated with anti-TNF prior to vedolizumab/ustekinumab/tofacitinib.

Exclusion Criteria:

* less than 18 years of age
Deep Anterior Lamellar Keratoplasty (DALK)

The purpose of this study is to report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.

Purpose: To report outcomes of deep anterior lamellar keratoplasty (DALK) using the big-bubble technique.

Methods: Thirty four unselected consecutive patients were submitted to DALK big-bubble technique. Intraoperative and postoperative complications, postoperative uncorrected visual acuity (UCVA), best spectacle-corrected visual acuity (BSCVA), spherical equivalent (SE), corneal topography, and endothelial cell density were evaluated. All patients were followed for at least 6 months.

Eligibility Criteria:
Inclusion Criteria:

* keratoconus

Exclusion Criteria:

* central endothelial cell count less than 2000 cells/mm2
* glaucoma or intraocular pressure greater than 21 mmHg
* amblyopia
* retinal abnormalities
* diabetes mellitus
* steroid or immunosuppressive treatment
* connective tissue diseases
Treatment of Crowding Without Extraction Using Self Ligating Brackets

This experimental study will evaluate the effect of active and passive self-ligating brackets in treatment of crowding, compared with the control group of conventional brackets in class I malocclusion without extraction.

The study sample will consist of 66 patients with 3-6mm crowding. The sample will be allocated randomly into two experimental groups, in addition to a control group.

The brackets will be applied using indirect bonding method for all patients. The dentoalveolar changes occurring after leveling and alignment teeth will be assessed by using CBCT radiographs; pre and post- treatment changes for each group will be evaluated individually.

Producing of modern and various brackets systems both self- ligating and conventional make the 3 dimensional important in order to evaluate the root positions and to investigate EARR in multi root teeth, so the research will depend on CBCT to carry out these purposes in our study. Beside to compare the duration of alignment among groups.

Fixed appliances will be applied into three groups as 1. Active self ligating brackets (ASLB), 2. Passive self ligating brackets (PSLB), 3. Conventional brackets (CB) until reach to wire 19\*25 S.S upper and lower. During leveling, thermal activated wires will be used in all patients.

CBCT images will be done before and after leveling and alignment of teeth to compare dentoalveolar changes between study groups.

Eligibility Criteria:
Inclusion Criteria:

* patients permanent dentition stage.
* crowding up to 6 mm
* Class I relationship.
* Good oral hygiene.

Exclusion Criteria:

* Poor oral hygiene.
* Previous orthodontic treatment.
* Patients with syndromes, clefts, or craniofacial abnormalities.
* Class II or III skeletal anteroposterior relationship.
* Crowding less than 3mm and more than 6mm.
Identification of Obstacles and Levers to Interdisciplinary Work in Palliative Care Units

Palliative care is active care delivered by a multidisciplinary team, in a global approach to the person suffering from a serious, progressive illness, in an advanced phase, with a fatal outcome. Their goal is to relieve physical pain and other symptoms, but also to take into account psychological, social and spiritual suffering.

Palliative care and support are interdisciplinary. They are aimed at the patient as an individual, their family and loved ones, at home or in an institution. Training and support for caregivers and volunteers are part of this approach.

Recent years have seen the development of teaching in the discipline both during the initial course and through continuing training actions, the latter based on the very notion of multi-professionality. But it is clear that during the initial course of health professionals, learning remains confined to professions, in silos.

It is in view of this observation that the 2015-2018 palliative care development plan in France proposed the establishment of transversal teaching, for health students, through its measures 4.1 and 4.2, lessons put in place at through local initiatives which are still underdeveloped.

It is therefore appropriate to question the methods of learning "know how to work together". This work therefore aims to reflect, through what can promote but also hinder interdisciplinary work, on the way in which health students can be taught to work in interdisciplinarity and in particular during their internships in palliative care structures


Eligibility Criteria:
Inclusion Criteria:

* Health professionals, all professions combined, working in palliative care units agreeing to participate in research
* Health students (hospital students, nurses, etc.) doing an internship in a palliative care unit agreeing to participate in research
* Agreeing to participate in the study

Exclusion Criteria:

* Refusal to participate in research
Cynergy: the CYPHER-NEVO Registry

The purpose of this registry is to compare the safety and the performance of the NEVO™ Sirolimus-eluting Coronary Stent, once commercially available, to the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in complex subjects presenting with acute STEMI for primary intervention, diabetes mellitus or multi vessel disease. The second purpose of this registry is to evaluate the safety and performance of the NEVO™ Sirolimus-eluting Coronary Stent, once commercially available and the CYPHER Select® Plus Sirolimus-eluting Coronary Stent in complex subjects diagnosed with acute STEMI for primary intervention, diabetes mellitus and/or multi vessel disease.

The data will be collected from subjects treated with commercially available product and following routine clinical practice. Uniform, complete and accurate data will be collected on the subject's medical history, peri-procedurally, during the index hospitalization, and during follow-up.

The CYPHER Select® Plus Sirolimus-eluting Coronary Stent (SES) is a balloon-expandable intracoronary 316L stainless steel stent with a coating that consists of a blend of Sirolimus and polymers.

Sirolimus is a potent immunosuppressive agent which has been proven to prolong graft survival in many animal models of transplantation. Sirolimus prevents both proliferation and migration of smooth muscle cells (in vivo and in vitro) in graft and balloon injury models. Furthermore, Sirolimus has been shown to be effective in reducing restenosis and the need for repeat revascularization while demonstrating superior efficacy measures such as angiographic late loss and binary restenosis.

The NEVO™ Sirolimus-eluting Coronary Stent is a cobalt-chromium alloy stent platform that incorporates two unique features: reservoir technology, and a bioresorbable polymer which prevents initial contact between the polymer and the vessel wall and chronic polymer exposure. This design minimized initial tissue exposure to polymer, and also enables polymer resorption within approximately three months.

Eligibility Criteria:
Inclusion criteria:

- Subjects treated in routine clinical practice with a NEVO™ Sirolimus-eluting Coronary Stent once commercially available, or a CYPHER Select® Plus Sirolimus-eluting Coronary Stent and diagnosed with acute STEMI for primary intervention and/or diabetes mellitus and/or multi vessel disease.

Exclusion criteria:

* In case, during the index procedure, the subject was treated with a stent other than the CYPHER Select® Plus Sirolimus-eluting Coronary Stent or the NEVO™ Sirolimus-eluting Coronary Stent or a mix of the CYPHER Select® Plus SES and NEVO™ SES
* In case, during the index procedure, the subject was treated with other therapy (e.g. balloon angioplasty, cutting balloons, directional coronary atherectomy, excimer laser, rotational atherectomy, thrombectomy, etc.) in segments not ultimately treated with a CYPHER Select® Plus SES or NEVO™ SES.
Curarisation and Intubation Conditions During Videolaryngoscopy With Glidescope Titanium

In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium) group) or no (control group) within elective surgery patients with no difficult intubation prediction

In this prospective, randomized study, the investigators assess the intubation conditions during videolaryngoscopy with Glidescope Titanium whether patients receive (curare (Atracurium)group) or no (control group) within elective surgery patients with no difficult intubation prediction. The IDS score assessed by an anesthesiologist from the video-recording is the primary outcome. All general anesthesias are standardized using Target Control Infusion of propofol and sufentanil. The investigators also compare IDS scores as assessed by intubators, time for tracheal intubation, and laryngeal morbidity in both groups.

Eligibility Criteria:
Inclusion Criteria:

* Elective Surgery Adult Patients
* no difficult intubation prediction

Exclusion Criteria:
Double Blind, Placebo-controlled, Study of the Safety, Tolerability and Pharmacokinetics of AIN457 in Rheumatoid Arthritis Patients

Evaluate the safety, tolerability and pharmacokinetics of AIN457 when administered as a single dose (intravenous infusion) in patients with active rheumatoid arthritis in combination with a stable dose of methotrexate. And to compare efficacy on the dose groups.


Eligibility Criteria:
Inclusion Criteria:

* Male and female patients with active rheumatoid arthritis in combination with a stable dose of methotrexate aged 18-75 years may participate in this trial.
* Post menopausal or surgically sterile female patients are allowed. Women of child-bearing potential may participate if they are on a stable dose of methotrexate and if they are practicing effective contraception for at least 6 months prior to screening, willing to use 2 forms of contraception, including at least 1 barrier method during the study and for at least 2 months following the completion/discontinuation of the study.
* Patients must have a diagnosis of active rheumatoid arthritis of stages I, II or III (ACR 1987 revised classification for criteria for RA). Disease duration of at least 6 months prior to randomization is essential;

Exclusion Criteria:

* Current treatment with anti-TNF-α or anti IL-1 therapy (or other biological therapy).
* Patients with congestive heart failure or poorly controlled diabetes mellitus (HbA1c value ≥10%).
* Presence of any major chronic inflammatory autoimmune diseases like psoriasis, psoriatic arthritis, spondyloarthropathy, inflammatory bowel disease or SLE that can mimic rheumatoid arthritis diagnosis or that can interfere with efficacy evaluation in the study.
* History of renal trauma, glomerulonephritis or patient with one kidney.
* Pregnant or breastfeeding women will be excluded.
* A positive tuberculin skin test.

Other protocol-defined inclusion/exclusion criteria may apply.
Experience With H.P. Acthar Gel Treatment of Patients With Nephrotic Syndrome/Proteinuria Due to Various Etiologies and Its Effect on Podocyte Function

Patients with proteinuria to start treatment with Acthar and watch a variety of clinical parameters with a goal of decreasing proteinuria between 50-100% over a period of nine months with every 3 months increasing the dose of medication until a decrease of either 50- 100 % of protein excretion is achieved.

In addition addition podocyte function will be assessed monthly by measuring suPar levels, tnf alpha, podocyte/creatinine levels as well as podocyte function studies.

Patients with proteinuria/nephrotic syndrome with albumin/creatinine ratios of 50 or 24 hour urine protein of 500mg or greater will receive increasing doses of H.P. Acthar Gel starting with 20 units weekly or biweekly for 3 months after a one month washout observational period.

The second three month period calls for 40 units biweekly, and the third three month period uses 80 units biweekly observing if the reduction in proteinuria reaches a goal of 50-100%.

Pre study clinical parameters include Cbc diff, cmp, lipid with ldl, cortisol, acth, 24 hour urine for creatinine and protein, urine albumin/creatinine ratio, protein/creatinine ratio, bone density, hgba1c, weight , blood pressure, vital signs, and overall health questionaire. Monthly cbc, cmp, prot/creat, alb/creat ratios, and one red top tube and one 50cc urine container to go to MGH Charlestown for basic podocyte studies. The fourth -3 month observational period will be with tapering to stopping the dose of Acthar and following the same monthly and the pre study parameters.

A second year of observation will continue checking patients every other month for one year to determine the length of protein decrement observed in the first year.

The study will conclude after the second year of drug free followup.

Biomarker studies of podocyte function will be done for the full 2 year period.

Final data analysis will conclude after the 2 year period of observation.

Eligibility Criteria:
Inclusion Criteria:

* patients with proteinuria as above. patients with controlled conditions below are candidates.

Exclusion Criteria:

* uncontrolled hypertension,diabetes mellitus, congestive heart failure, coronary artery disease, peripheral vascular disease.
Retrospective Study on the Outcome of Cleft Palate Repair: Comparing US Surgical and Ethicon Suture Materials

Investigator initiated retrospective chart review to study the effects of changing suture material on the healing and outcome of cleft palate surgery were.

This study aims to show what the effects of changing suture material were on the healing and outcome of cleft palate surgery. The study will be considered successful if we find that either there is an effect on the healing after surgery, one of the suture materials seems to promote better healing and final outcome, or that there is no difference between the suture materials.

Eligibility Criteria:
Inclusion Criteria:

* Cleft palate repair performed at UCDMC between 1/1996 and 6/2006

Exclusion Criteria:

* Those who do not meet the inclusion criteria