cyrilzakka/clinical-trials huggingface dataset:
Effect of Yellow-Tinted Intraocular Lens on Standard Automated Perimetry (SAP) and Short-wavelength Automated Perimetry (SWAP) in Patients With and Without Glaucoma

To investigate the effect of yellow-tinted IOLs on the Short Wave-length Automated Perimetry (SWAP) and Standard Automated Perimetry (SAP) in patients with and without glaucoma.

Glaucoma is mostly a disease of old people and is highly accompanied with cataract.Some of these patients may need to perform cataract surgery during the course of glaucoma. But in glaucoma patients, the effect of cataract surgery and/or type of implanted intraocular lens (IOL) on the results of specific visual field tests, like SWAP, is still not well studied.From the past decade, various yellow-tinted IOLs with the speculation of protecting the retinal photoreceptors and decreasing the incidence of age-related macular degeneration have been introduced.These blue-light-filtering IOLs contain a yellow chromophore that filters ultra violet (UV) and a larger part of the high-energetic visible blue-light between 380 and 500 nm. Based on previous studies yellow-tinted IOLs decrease the amount of light transmission to the retina which may theoretically affect perimetry results. This might be even more important in patients with glaucoma where the sensitivity of test locations has decreased per se.

Since early diagnosis of glaucoma and its progression is highly dependent on visual field results, it is important to evaluate the effect of these IOLs on perimetry, particularly on SWAP, in which the blue-light-filtering IOLs might interfere with its findings.

Eligibility Criteria:
Inclusion Criteria:

* In group 1, visually significant cataract associated with well controlled mild to moderate open angle glaucoma (intraocular pressure \< 18 with maximally-tolerated medical treatment)and no history of previous intraocular surgeries
* In group 2- Normal ophthalmic examination other than visually significant cataract

Exclusion Criteria:

* Diabetes mellitus
* neurological disease which may affect the results of visual field
* known systemic medication with involvement on visual field
* spherical refractive error less than -5 and more than +5 diopter
* cylindrical correction more than 3 diopter
Fatigue and Hearing Loss.

An intervention group and a control group will complete a battery of questionnaires at four time points to investigate the impact of first-ever hearing aid fitting on fatigue and associated variables. The study is observational as all participants in the intervention group will already be receiving their first-ever hearing aid as part of their routine audiological care.

Hearing Impairment leads to increased listening effort which could result in short and/or long term fatigue. Previous research has shown that people with a hearing loss score higher on fatigue questionnaires than people without a hearing loss. Hearing Aid fitting has been shown to reduce fatigue in an objective measurement study, however no reduction has been shown using subjective measurement. To examine the effect of hearing aid fitting on fatigue a longitudinal study will be conducted. A battery of questionnaires measuring fatigue, listening effort, daily activity, need for cognition and hearing handicap as well as an objective hearing test will be conducted at 4 time points. These time points will be a baseline assessment before hearing aid fitting, 2 weeks after fitting (\~3 months after baseline), 3 months after fitting and 6 months after fitting. A control group with no change in hearing aid status will also be measured at these time points. The study is observational as all participants in the intervention group will already be receiving their first-ever hearing aid as part of their routine audiological care. This study monitors the effect of the hearing aid fitting.

The general hypothesis is that hearing aid fitting will reduce fatigue. More specifically it is expected that fatigue will increase immediately after fitting and then decrease by the 6 month time point. It is also expected that social activity levels will increase after fitting and that individual differences in this activity change will explain some of the differences between participants in rate of change in fatigue. It is predicted that high Need for Cognition and Hearing Handicap scores will increase the amount of change in fatigue for the intervention group. 57 participants will be recruited for each group, each participant being involved in the study for no more than 7 months with the study running for a total of 15 months. The data will be analysed using multi-level analysis.

Eligibility Criteria:
Inclusion Criteria:

* A self-reported hearing loss.
* Aged between 18 and 75 years old.

Inclusion criteria for intervention group only:

* Must already have an appointment arranged to receive a hearing aid for the first time.

Inclusion criteria for control group only:

* No change in hearing aid status (including new models) for the past 1 year.

Exclusion Criteria:

* Non fluent English speakers. (To maintain validity of results as English language questionnaires are used)
* Inability to read (In order to complete the questionnaires).
* Inability to visit on multiple occasions over 7 months (e.g. can't be planning to move away from the area).
* Inability to give full informed consent.
* Primary complaint of tinnitus.
A Phase 3 Study to Evaluate Safety and Biomarkers of Resmetirom (MGL-3196) in Patients With Non-alcoholic Fatty Liver Disease (NAFLD), MAESTRO-NAFLD-Open-Label-Extension (MAESTRO-NAFLD-OLE)

A 52-Week, Multi-center, Open-label, Active Treatment Extension Study to Evaluate Safety and Tolerability of Once Daily, Oral Administration of Resmetirom (MGL-3196)


Eligibility Criteria:
Inclusion Criteria:

* For patients who completed MAESTRO-NAFLD-1, completed the Week 52 visit, and completed the Week 56 visit within 90 days of the Extension Day 1 visit, and are willing to participate in MAESTRO-NAFLD-OLE and provide written informed consent.
* For patients who screen failed MAESTRO-NASH, must provide written informed consent for MAESTRO-NAFLD-OLE and must have screened and met all eligibility requirements for MAESTRO-NASH within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE and have a liver biopsy that is ineligible for MAESTRO-NASH within 6 months of the Extension Day 1 visit. Eligible liver biopsy for MAESTRO-NAFLD-OLE must have one of the following results:

  * NAS = 3, steatosis 1, ballooning 1, inflammation 1, OR NAS = 3, ballooning 0, with F1B, F2 or F3
  * NAS ≥ 4, at least 1 in all NAS components, F1A or F1C, PRO-C3 ≤ 14 (NASH, but ineligible for MAESTRO-NASH)
  * Compensated NASH cirrhosis based on biopsy at screening of MAESTRO-NASH and baseline of MAESTRO-NAFLD-OLE, including Child Pugh-A (score 5-6), MELD \<12, albumin ≥3.2, and bilirubin \<2
* For patients who screen failed from MAESTRO-NASH OUTCOMES and de novo patients, must have documented CP-A/B (score \<8) NASH cirrhosis (including minimal decompensation) and MELD \<15 unless MELD \>=15 based on non-cirrhotic parameters. MAESTRO-NASH OUTCOMES screen failures must have screened and met all eligibility requirements for MAESTRO-NASH OUTCOMES within 90 days of the Extension Day 1 visit for MAESTRO-NAFLD-OLE .

Exclusion Criteria:

* A history of significant alcohol consumption for a period of more than 3 consecutive months within 1 year prior to Extension Day 1.
* Diagnosis of hepatocellular carcinoma or other carcinomas that may prevent participation in the Extension study.
* Chronic liver diseases
* Has an active autoimmune disease
* Any other condition which, in the opinion of the Investigator, would impede compliance, hinder completion of the study, compromise the well-being of the patient, or interfere with the study outcomes.
Identifying and Managing Alcohol-related Health Problems in General Practice

The overall purpose of the proposed research is to increase patients' and general practitioners' (GPs') awareness of alcohol as a relevant factor for a wide variety of health problems in general practice, and enable earlier help and treatment. To achieve this, the investigators aim to test the feasibility of a pragmatic strategy for identification of alcohol-related health problems, and the feasibility of a web-based intervention between consultations, as a supplement to usual care in general practice.

Alcohol use is a major health problem, and there is a strong need for improved identification of and interventions for alcohol-related health problems. These constitute somatic and neuropsychiatric health problems, caused, precipitated, or complicated by alcohol use.

The investigators will especially recruit patients in late adulthood (60+), as this group may experience more barriers with digital interventions, and will have more health problems potentially affected by alcohol. The investigators have developed the identification strategy and the interventions in close collaboration with key stakeholders: patients and health care professionals.

The aim is to test the feasibility of interventions for hazardous (a quantity or pattern placing patients at risk for adverse health events) and harmful alcohol consumption (consumption resulting in adverse events), with two distinct components, namely pragmatic case finding and a digital self-administered intervention (called Endre) for use between consultations. The study will focus mainly on aspects related to acceptability, demand, implementation and practicality. The results from this feasibility study may give valuable knowledge on how this treatment approach should be adapted and implemented, and will indicate whether a full-scale RCT is warranted. This study is testing the feasibility of interventions intended to facilitate change for both patients (reduced alcohol consumption) and for physicians (improved addressing of alcohol and improved intervention delivery).

Eligibility Criteria:
Inclusion Criteria:

* Registered patient with participating clinic, accepting that alcohol may be relevant for his/her health problem and wanting to participate

Exclusion Criteria:

* None, except age
High-intensity Interval Versus Combined Exercise Training in CHF

Chronic heart failure (CHF) is a clinical syndrome presented with central, cardiac deterioration as well as peripheral vascular and muscular abnormalities, resulting finally to reduced exercise tolerance, quality of life and mortality rates. Exercise training is a major component of rehabilitation / secondary prevention interventions, inducing significant beneficial changes in mechanisms of pathophysiology, exercise tolerance, functional capacity and quality of life, while a positive impact on hospitalization and mortality reduction should not be also excluded. There has been growing interest in the characteristics and modalities of exercise training able to induce optimal benefits. High intensity and interval mode have been shown to induce greater benefits than moderate intensity and continuous mode regimes. Additionally, there has been sound rationale for the inclusion of strength training, which has been also shown able to yield benefits in terms of exercise capacity and quality of life. However, there haven't been much data on the so called combined regimes, which include both aerobic exercise and strength training. This study aims at investigating the effects of combined high-intensity interval and strength training compared to high-intensity interval exercise alone in CHF.


Eligibility Criteria:
Inclusion Criteria:

* stable heart failure
* ejection fraction \<=45%
* optimal medical treatment
* NYHA class \<=III

Exclusion Criteria:

* contraindications for maximal cardiopulmonary exercise testing (CPET)
* moderate to severe COPD
* inability to follow exercise programs due to orthopaedic problems
Low Fat Diet for Fatigue in MS

A randomized, controlled pilot trial of a dietary intervention vs. wait-list control in patients with MS and fatigue for management of their fatigue. The hypothesis of this study is that participants following the low-fat study diet will demonstrate a significant reduction in fatigue after four months compared to wait list controls.


Eligibility Criteria:
For participants with MS:

Inclusion Criteria:

* Age 18-70
* Diagnosis of MS by 2010 McDonald Criteria
* EDSS ≤ 7.5
* Experiencing moderate to severe fatigue (MFIS ≥ 38)

Exclusion Criteria:

* Current cardiopulmonary disease requiring treatment
* Diabetes
* Pregnancy or breast-feeding
* MS exacerbation within 30 days of screening visit
* IV steroids within 30 days of screening visit
* Dietary fat content of \<30% as assessed by food frequency questionnaire (FFQ) at screening visit
* Fish oil or flax seed oil supplementation within 30 days of screening visit
Annual Study to Investigate Inactivated Subunit Influenza Vaccine Due to New Virus Strains for the 08/09 Season.

Influenza (flu) viruses change continuously, therefore also the parts of viruses used in influenza vaccines can vary from year to year. In Europe, manufacturers/marketing holders of these vaccines are required to be involved in ongoing clinical trials and to present the results to the competent authorities each year. The current study is a phase IIIa clinical trial with a commercially available vaccine (Influvac®) supplied in pre filled syringes. It is part of the ongoing clinical trial program for Influvac® and will be done to assess the immunogenicity and safety and tolerability of next season's trivalent influenza subunit vaccine in two groups of healthy subjects: subjects aged \>= 18 and \<= 60 years and subjects \>= 61 years of age (elderly).


Eligibility Criteria:
Inclusion Criteria:

* Willing and able to give informed consent and able to adhere to all protocol required study procedures.
* Men and women aged ≥ 18 and ≤ 60 years or ≥ 61 years of age at the day of study vaccination.
* Being in good health as judged by medical history, physical examination and clinical judgment of the investigator.

Exclusion Criteria:

* Known to be allergic to eggs, chicken protein, gentamicin or any other constituent of the vaccine.
* A serious adverse reaction after a previous (influenza) vaccination. Presence of any significant condition that may prohibit inclusion as determined by the investigator.
* Having received vaccination against influenza within the previous six months before study vaccination or planned vaccination during the study period.
* A history of Guillain-Barré syndrome or active neurological disease.
A Phase 2b, Study of Linsitinib in Subjects With Active, Moderate to Severe Thyroid Eye Disease (TED)

The overall objective is to study the safety, pharmacokinetics and efficacy of linsitinib (a small molecule IGF-1R inhibitor) administered orally twice daily (BID) vs. placebo, at 24 weeks in the treatment of subjects with active, moderate to severe thyroid eye disease (TED).


Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of Graves' Disease and/or autoimmune Hashimoto's thyroiditis associated with active moderate to severe TED with a CAS ≥ 4 (on the 7- item scale) for the most severely affected eye (primary study eye) at Screening and Baseline
* Confirmed active TED (not sight-threatening but has an appreciable impact on daily life, with onset (as determined by patient records) within 12 months prior to the Baseline visit and usually associated with one or more of the following: lid retraction ≥ 2 mm, moderate or severe soft tissue involvement, exophthalmos ≥ 3 mm above normal for race and gender, and/or inconstant or constant diplopia.
* Subjects must be euthyroid with the participant's baseline disease under control or have mild hypo- or hyperthyroidism (defined as free thyroxine \[FT4\] and free triiodothyronine levels \[FT3\] \< 50% above or below the normal limits) at Screening.
* Does not require immediate ophthalmic surgery, radiotherapy to orbits or other ophthalmological intervention at the time of Screening and is not planning for any such treatment during the course of the study.

Exclusion Criteria:

* Decreased best corrected visual acuity due to optic neuropathy as defined by a decrease in vision of 2 lines on the Snellen chart, new visual field defect, or color defect secondary to optic nerve involvement within the last 6 months.
* Corneal decompensation unresponsive to medical management.
* Previous orbital irradiation or orbital surgery.
* Any glucocorticoid use (intravenous \[IV\] or oral) with a cumulative dose equivalent to \>= 1g of methylprednisolone or equivalent for the treatment of TED within 3 months of Screening.
* Prior IGF-1R inhibitor therapy for any condition.
The Influence of Non-Carious Cervical Lesions on Root Coverage

The goal of this prospective cohort study is to evaluate the effect of non-carious cervical lesions (NCCLs) on the outcome of root coverage therapy. The main question it aims to answer is: In gingival recessions associated with NCCLs, characterized by an undetectable cemento-enamel junction (CEJ), reconstruction of the CEJ with a cervical composite restoration, prior to root coverage surgery by means of a coronally advanced flap combined with a connective tissue graft (CAF+CTG), provides similar clinical and patient-reported outcomes, as compared to the treatment of gingival recessions associated with NCCLs, characterized by a visible CEJ, with root coverage surgery only, by means of a CAF+CTG.

In NCCLs where the CEJ is undetectable (B-type defect), the CEJ will be reconstructed before surgery with a cervical composite restoration mimicking the anatomic features of the contralateral, homologous tooth. CAF+CTG treatment will be performed in all cases. Participants will be assessed at 6 weeks, 3 months, and 6 months to evaluate clinical, volumetric, and patient-centred outcomes.

In this investigation, a prospective cohort study, several key outcomes will be assessed. First, we seek to determine whether restoring the cementoenamel junction (CEJ) in Class B GRs before root coverage therapy yields comparable clinical and volumetric outcomes to Class A GRs with detectable CEJ. In addition, the influence of the CEJ restoration on dentin sensitivity and aesthetic satisfaction of the patient will be investigated. To our knowledge, it will be the first clinical study to use Pini Prato et al.'s surface discrepancy classification as a decision-making tool to guide periodontal-restorative procedures.

Eligibility Criteria:
Inclusion Criteria:

* Systemically healthy individuals older than 18 years old;
* Healthy periodontal status according to the AAP/EFP definition;
* Full-mouth plaque (FMPS) and bleeding scores (FMBS) ≤ 20%;
* At least one facial RT1 GR in single-rooted teeth with a minimum depth of 2 mm, associated with a NCCL;
* No history of periodontal surgery at the experimental site(s).

Exclusion Criteria:

* Pregnancy or lactation;
* Self-reported smoking ≥10 cigarettes/day;
* Metabolic diseases that negatively affect soft tissue healing (i.e., diabetes mellitus);
* Any medication that may interfere with wound healing;
* Prosthetic crown at experimental teeth;
* Ongoing orthodontic therapy.
Children's Nail Bed Injuries : Study of the Efficacy of the Simple Relocation of Nail Plate

Nail bed injuries in children, most frequently under 3 years-old, result in crush injuries. The frequency is around 34 percent of the children hand injuries (Claudet et al, 2007). The empirical reparation technique is the nail bed suture and the relocation of the nail plate. However, some authors think that suture the nail bed could increase the traumatism of the nail bed because of the needle, the crush by the clamps and by the stitches too tight (Langlois, Yam). An author has proposed, in a prospective, randomized clinical trial to treat the nail bed injuries with a glue: the 2-octylcyanoacrylate, without suture of the nail bed. Advantages of this technique, claimed by the author, was time saving, with an aesthetical result as same as the treatment with suture of the nail bed. A same study validated the technique in a paediatric population (Langlois et al., 2010). So, it seems that it is not necessary to suture the nail bed. But, in our practice, the investigators noted complications not mentioned in previous studies: hematomas causing pain, effusion and dislocation of the nail plate, with constrain the patient to consult in emergency. The 2-octylcyanoacrylate is difficult to use in nail bed injuries and is expensive. Our hypothesis is the simple relocation of the nail plate in nail bed injuries in paediatric population is enough to have good to excellent aesthetical results, with less complications and a lower cost, than the other techniques. The aim of this study is to assess the aesthetical results 3 months after simple relocation of the nail plate for nail bed injuries in children.


Eligibility Criteria:
Inclusion Criteria:

* age under 18 yo
* nail bed injuries and/or nail matrix
* nail plate \> 30% of the surface comparing the opposite side
* one or more digits
* signature of the 2 parents
* social security

Exclusion Criteria:

* loss of more than 30% of the surface of the nail bed
* Multiples lesions: nerve injury, tendon, fracture or luxation without indication of osteosynthesis, loss of skin with indication of a flap
* osteosynthesis of the distal phalanx
* injuries by bite
* previous pathology of the nail
* contraindication of Lidocaine, bicarbonate de sodium, Kalinox, Biseptine, Vicryl rapide, Adaptic
* no information possible
* pregnancy
* breastfeeding
* other inclusion in another study