cyrilzakka/clinical-trials huggingface dataset:
Post-approval Study of the DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System

This study is being conducted to gather medium and long-term information regarding the performance and safety of the commercially available DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System.

This two-phased study on hip arthroplasty consists of a clinical follow-up phase and a clinical outcomes phase.

The DURALOC® Option Ceramic-on-Ceramic Hip Prosthesis System consists of:

1. a modular ceramic bearing insert that secures to a titanium metal alloy DURALOC® Option Acetabular Shell via a taper locking mechanism; and
2. a ceramic femoral head that is attached to a conventional femoral stem to complete the total hip prosthesis device configuration.

Eligibility Criteria:
Inclusion Criteria:

* Skeletally mature
* Provide informed consent
* Sufficient acetabular and femoral bone stock to seat the prosthesis
* Willing and able to return for follow-up as specified by the study protocol
* Willing and able to complete the hip outcomes questionnaire and quality of life survey (SF12)
* Undergo hip replacement due to non-inflammatory joint disease, including osteoarthritis, avascular necrosis, congenital hip dysplasia or post-traumatic arthritis.

Exclusion Criteria:

* Diagnosis of inflammatory arthritides such as rheumatoid arthritis, juvenile rheumatoid arthritis, psoriatic arthritis, systemic lupus, erythematosis etc.
* Active infections that may spread to other systems such as osteomyelitis, pyogenic infection of the hip joint overt infection, etc.
* Loss of musculature, neuromuscular compromise or vascular deficiency in the affected limb which impedes evaluation.
* Poor bone quality (e.g. osteoporosis) such that there is concern about the ability of inadequate bone stock to support the implant.
* Morbid obesity
* Involvement in high levels of activity or participation in active sports
* Involvement in heavy manual labor employment
* Increased likelihood of falls due to concomitant illnesses or impairment
* Pregnancy, breast-feeding, a prisoner, mentally incompetent, a known alcohol or drug abuser
* Diagnosis of metabolic disorders or receiving systemic pharmacological treatments leading to progressive deterioration of solid bone support for the implant
* Known history of conditions that may interfere with the total hip arthroplasty survival or outcome (e.g. Paget's disease, Charcot's disease)
* Known presence of active metastatic or neoplastic disease
* Known allergic reactions to implant materials (e.g. ceramic, metal)
* Known history of tissue reactions to implant corrosion or implant wear debris
* Disabilities of other joints that impedes evaluation (e.g. knees, ankles)
* Known presence of highly communicable disease or diseases that may limit follow-up (e.g. immunocompromised conditions, hepatitis, active tuberculosis etc.)
* Previous prosthetic hip replacement device (any type including THA, surface replacement arthroplasty, endoprosthesis etc.)
Safety and Efficacy of IDP-122 in the Treatment of Participants With Plaque Psoriasis

This study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult participants with moderate to severe plaque psoriasis (defined as an Investigator's Global Assessment \[IGA\] score of 3 or 4).

This study is a multicenter, double-blind, randomized, parallel-group study designed to assess the safety and efficacy of IDP-122 Lotion in comparison with its vehicle. To be eligible for the study, participants must be at least 18 years of age and have a clinical diagnosis of moderate to severe psoriasis (defined as an IGA score of 3 or 4).

Eligibility Criteria:
Key Inclusion Criteria:

* Male or female, of any race, at least 18 years of age (inclusive).
* Freely provides both verbal and written informed consent.
* Has an area of plaque psoriasis appropriate for topical treatment that covers a body surface area (BSA) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
* Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
* Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4 (the face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded from this calculation, if psoriasis is present).

Key Exclusion Criteria:

* Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the Investigator.
* Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the Investigator.
* Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the Investigator.
* Is pregnant, nursing an infant, or planning a pregnancy during the study period.
* Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit or is concurrently participating in another clinical study with an investigational drug or device.
Open Label Placebo in the Treatment of Low Back Pain

Patients will be randomized to receive open-label (honestly described placebo) immediately at baseline or be eligible to receive the open-label treatment three weeks after the baseline measurements. Therefore all patients will be eligible to receive open-label placebo treatment for their chronic low back pain during the course of the study.

Chronic low back pain (cLBP) is a debilitating and costly condition that affects 1.2 million Portuguese with an estimated cost in the United Stated of $50 billion. Randomized controlled trials has shown that placebo interventions can dramatically reduce chronic low back pain and its associated disability. Generally, it is assumed that response to placebo requires concealment or deception, which presents a dilemma to the clinician. In clinical practice, how can patients benefit from an available, effective and potentially cost-effective intervention without being deceived? This study seeks to determine ethically acceptable open-label placebo treatment (with full informed consent) can lead to meaningful benefits. The primary study will involve 80 patients with cLBP who will be randomly assigned to a three-week course of either non-deceptive open-label placebo pills in the context of a persuasive rationale + treatment as usual or to be continued on their treatment-as-usual. Primary outcome measures will be pain intensity and symptom bothersomeness on the previous week. Additionally, the study will investigate a possible association between the genetic variation of the catechol-O-methyltransferase (COMT polymorphisms) with the hypothesized observed placebo effect on cLBP patients. Participants will be followed for 3 weeks with a mid-point (11 days) visit. Patients who receive only usual care for the first three weeks will be eligible to elect a three week course of treatment with open-label placebo after which they will be assessed. This study has been submitted and approved by the following review board: Comissão de Ética do Centro Hospitalar de Lisboa Ocidental (Lisbon West Hospitals Centre's Ethical Committee) Institutional Review Board.

Eligibility Criteria:
Inclusion Criteria:

* Male or female
* 18 years or older
* Low back pain complaints for a min. of 3 months

Exclusion Criteria:

* use of strong opioid analgesic and/or anticonvulsant medication;
* specific causes of back pain namely cancer, fractures and infections;
* complicated back problems (e.g. prior back surgery);
* conditions making treatment difficult (e.g. paralysis, psychoses);
* conditions that might confound treatment effects or interpretation of results (e.g. severe fibromyalgia, rheumatoid arthritis);
* concurrent care from other providers;
* conditions that affect safety of patient (e.g. pregnancy);
* concurrent medical legal issues.
Post-authorisation Passive Enhanced Safety Surveillance of Seasonal Influenza Vaccines: Pilot Study in England

This pilot study, to be conducted in the 2017/2018 influenza season, is a safety surveillance study using passive surveillance enhanced with a reporting card system to report adverse events of interest (AEIs) after Flu vaccination.

This is the third pilot study following, EPI-FLU-045 VS UK \[NCT02567721\] and EPI-FLU-046 VS UK \[NCT02893878\] studies, carried out in the 2 previous influenza seasons (2015/2016 and 2016/2017). This study will collect data about vaccination status and adverse events following influenza immunisation (AEFI) on a weekly basis, from 01 September 2017 onwards, using a customized Adverse Drug Reaction (ADR) Cards and data from Electronic Health Records system for a period of approximately 13 weeks.

Eligibility Criteria:
Inclusion Criteria:

* All individuals who receive influenza vaccination among the 10 participating GP practices between 1 September and 30 November 2017 are eligible for inclusion in the analysis.

Exclusion Criteria:

* Registered patients who have explicitly opted out of data sharing will be excluded from the analysis.
Group Cognitive Behavioural Family Intervention (CBFI) for People With Schizophrenia and Their Families

Cognitive behavioural family intervention (CBFI) is a brief psychosocial intervention that incorporates the model of cognitive behavioural therapy (CBT) into the family context. It builds upon the current trend of family interventions/psychoeducation with refocusing on the cognitive model within the family interpersonal relationship. Existing literature indicates that CBFI may be effective in improving positive and negative symptoms of people diagnosed with schizophrenia immediately following the programme. This mixed-method is to evaluate the feasibility and effectiveness of a CBFI programme for people with schizophrenia and their families in a local context. The findings may accumulate more evidence that CBFI is a brief and effective psychosocial intervention that is adapted to Hong Kong clinical settings.


Eligibility Criteria:
Inclusion Criteria:

Service users

* Diagnosis of schizophrenia-spectrum disorders, based on clinical judgement by the treating clinicians
* Aged 18-65
* Able to communicate in Cantonese

Family caregivers

* Aged above 18
* Living with service users
* Able to communicate in Cantonese
* Nominated by the service users

Exclusion Criteria:

Service users

* Having co-morbidity of learning disability
* Organic/neurological conditions
* Substance misuse disorder

Family caregivers

* Having active psychiatric conditions
* Looking after more than one family member suffering from chronic physical or mental illnesses
The Comparative Clinical Performance of Two Daily Disposable Toric Contact Lenses

This study aimed to compare the clinical performance of two daily disposable toric contact lenses.

This was a multi-center, randomized, participant-masked, bilateral study controlled by cross-comparison. Participants were assigned to either lens type in random sequence. Lenses were worn on a daily disposable wear schedule. Follow-up visits for each lens were performed after 1 week of wear.

Eligibility Criteria:
Inclusion Criteria:

1. They are at least 18 years old and have the capacity to volunteer.
2. They understand their rights as a research subject and are willing and able to sign a Statement of Informed Consent.
3. They are willing and able to follow the protocol.
4. They currently wear soft contact lenses or have done so in the past two years.
5. They have a spherical component of their contact lens prescription between Plano to - 6.00DS (inclusive).
6. They have a cylindrical component of their contact lens prescription between -0.75DC and -2.50DC (inclusive).
7. They can be satisfactorily fitted with the study lens types.
8. At dispensing, they could attain at least 0.20 logMAR distance high contrast visual acuity in each eye with the study lenses within the available power range.
9. They are willing to comply with the wear schedule (at least five days per week and for at least eight hours per day).
10. They own a wearable pair of spectacles.
11. They agree not to participate in other clinical research while enrolled on this study.

Exclusion Criteria:

1. They have an ocular disorder which would normally contra-indicate contact lens wear.
2. They have a systemic disorder, which would normally contra-indicate contact lens wear.
3. They are using any topical medication such as eye drops or ointment.
4. They are aphakic.
5. They have had corneal refractive surgery.
6. They have any corneal distortion resulting from previous hard or rigid lens wear or have keratoconus.
7. They are pregnant or breastfeeding.
8. They have any ocular abnormality which would, in the opinion of the investigator, normally contraindicate contact lens wear.
9. They have eye or health conditions including immunosuppressive or infectious diseases, which would, in the opinion of the investigator, contraindicate contact lens wear or pose a risk to study personnel; or a history of anaphylaxis or severe allergic reaction.
10. They are currently wearing one of the study contact lenses.
11. They have taken part in any other contact lens or care solution clinical trial or research, within two weeks prior to starting this study.
Use of Compromised Lung Volume in Monitoring Usage of Steroid Therapy on Severe COVID-19

Since December 2019, the outbreak of coronavirus disease 2019 (COVID-19) has become a public health emergency of international concern. Although corticosteroid therapy represents a milestone in the management of COVID-19, many questions remain unanswered. The optimal type of corticosteroids, timing of initiation, dose, mode of administration, duration, and dose tapering are still unclear. An approach to resolve these issues is to develop accurate tools to assess or monitor the progression of COVID-19 during the corticosteroid therapy process. Quantitative computed tomography (QCT) analysis may serve as a tool for assessing the severity of COVID-19 and for monitoring its progress. However, the effect of steroids on quantitative chest CT parameters during the treatment process remains unknown. In this retrospectively study, we aimed to assess the association between steroid administration and QCT variables in a longitudinal cohort with COVID-19

Since December 2019, the outbreak of coronavirus disease 2019 (COVID-19) has become a public health emergency of international concern. Although corticosteroid therapy represents a milestone in the management of COVID-19, many questions remain unanswered. The optimal type of corticosteroids, timing of initiation, dose, mode of administration, duration, and dose tapering are still unclear. An approach to resolve these issues is to develop accurate tools to assess or monitor the progression of COVID-19 during the corticosteroid therapy process. Quantitative computed tomography (QCT) analysis may serve as a tool for assessing the severity of COVID-19 and for monitoring its progress. However, the effect of steroids on quantitative chest CT parameters during the treatment process remains unknown. In this retrospectively study, we aimed to assess the association between steroid administration and QCT variables in a longitudinal cohort with COVID-19.

Eligibility Criteria:
Inclusion Criteria:

* (1) age 18-90 years
* (2) patients with severe or critical COVID-19.

Exclusion Criteria:

* (1) hematological or solid malignancies
* (2) patients with less than two CT scans during hospital stay
* (3) systemic corticosteroid or immunosuppressive therapy in the previous 6 weeks.
Study to Evaluate Effectiveness of a Weight Loss Program in Obese Patients During 3 Months Prior to Bariatric Surgery

Prospective multicenter observational clinical study on a dietary regimen in obese patients scheduled for bariatric surgery.

Study population: 25 patients with morbid obesity (BMI ≥ 40 kg / m2) or severe obesity (BMI 35 to 39.9 kg / m2) , with two or more comorbidities, scheduled for bariatric surgery within 3 months, and who will start treatment with the multidisciplinary weight loss program (PnK Method) based on diet, exercise and psychological support.

Patients will be followed-up for 3 months, with the following controls: pre-selection, baseline, month 1, month 2, month 3, and control when hospital discharge.

The treatment schedule in these patients will be as follows: a very low calorie ketogenic diet for at least 1 month or until losing 10% of the weight, and then, a low calorie diet with gradual reintroduction of natural foods for 2 months, until surgery.

The investigators will obtain retrospective data from 25 patients treated with the standard diet who met the same inclusion/exclusion criteria as the patients in this study and who similarly resemble in age, sex and BMI, for comparative analysis (control group).

Eligibility Criteria:
Inclusion Criteria:

* Patients of both sexes, between 18 and 65 years old
* Patients with morbid obesity (BMI ≥ 40 kg/m2) or with severe obesity (BMI 35 to 39.9 kg/m2), with two or more comorbidities associated with obesity (type 2 diabetes mellitus, arterial hypertension, obstructive sleep apnea, obesity hypoventilation syndrome, chronic respiratory disease, metabolic syndrome, atrial fibrillation, heart failure, pulmonary hypertension, cardiomyopathy, history of thrombosis, renal failure).
* Patients scheduled for bariatric surgery within 3 months ± 1 week.
* Patients who, regardless of their inclusion in this study, will undergo treatment with the multidisciplinary slimming program in study or standard diet.
* Patients who agree to participate and sign the Informed Consent

Exclusion Criteria:

* Pregnant or lactating women.
* Patients with type 1 diabetes mellitus or on insulin therapy
* Patients with eating disorders, alcoholism, and/or drug addiction.
* Patients with any severe psychological disorder (eg schizophrenia, bipolar disorder).
* Patients receiving dicumarinic anticoagulants (Sintrom®) or cortisone.
* Patients with liver failure.
* Patients with severe kidney failure (gfr \<30).
* Patients with hemopathies.
* Patients with cancer.
* Patients with cardiovascular or cerebrovascular disease (heart rate disorders, recent infarction \[\<6m\], unstable angina, decompensated heart failure, recent stroke \[\<6m\]).
* Patients in acute attack of gout.
* Patients with renal lithiasis verified by ultrasound.
* Patients with cholelithiasis verified by ultrasound.
* Patients with depression.
* Patients with electrolyte imbalance, according to medical criteria.
* Patients with orthostatic hypotension.
* Patients with contraindications to surgery
Study of Myobloc in the Treatment of Sialorrhea (Drooling) in Patients With Amyotrophic Lateral Sclerosis (ALS)

The purpose of this study is to determine the safety and efficacy of Myobloc in ALS patients who are having excessive drooling.

The primary goal of the study is to determine if the patient perceives a benefit from the Myobloc in controlling excessive drooling.

The secondary goals of this study are to:

* determine the safety of bilateral injections of Myobloc into the parotid and submandibular glands as an effort to control sialorrhea;
* determine by objective measures if the Myobloc injection decreases the saliva produced;
* determine caregiver perceived benefit from Myobloc injection.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of probable or definite ALS based on current World Federation of Neurology criteria
* Between the ages of 21-85, inclusive
* Sialorrhea refractory to treatment with at least two anticholinergic medications OR has been intolerant of anticholinergic medications due to side effects
* Capable of giving informed consent
* Must be able to attend all study visits

Exclusion Criteria:

* Patient has any uncontrolled significant medical, psychiatric or neurological disease (other than ALS) over the past 30 days
* History of ongoing substance abuse
* History of non-compliance with treatment in other experimental protocols
* Cannot provide informed consent or comply with evaluation procedures
* Has received any form of botulinum toxin in the past for any indication
* Women who are pregnant, lactating, or of child bearing potential not using an adequate form of birth control
* Currently being treated with coumadin
* Forced vital capacity (FVC) \<40% of predicted unless the tidal volume is \> 600cc, as patients with significant bulbar weakness may show a falsely low FVC due to bulbar muscle spasticity
Trifocal Diffractive Intraocular Lens After Cataract Extraction With Phacoemulsification

Multifocal IOLs that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been developed to create intermediate focus to overcome these difficulties. Continuous reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.

Monofocal IOLs, which provide effective distance vision, currently account for the majority of IOLs implantations. Patients who have undergone cataract surgery with implantation of monofocal IOL may require spectacles to perform near-distance (e.g., reading) or intermediate-distance (e.g., using a computer) tasks depending on their visual demandsMultifocal IOLs that maintain distance focus and improve near vision have been developed to reduce spectacle dependence.Multifocal IOLs improve patient performance of near-vision tasks, such as reading crafts, hobbies, and social activities to a greater extent than do monofocal IOLs. However, halos and reduced contrast sensitivity have been associated with multifocal IOLs and are common reasons for patient's dissatisfaction.Trifocal technology has been developed to create intermediate focus to overcome these difficulties. Continuous reports of the visual outcomes of the FineVision trifocal IOLs are encouraging.

Eligibility Criteria:
Inclusion Criteria:

* patient eyes had cataract with no other pathology, patients desire for spectacle independence after surgery and with realistic expectation.

Exclusion Criteria:

* Any ocular comorbidity that affect the end results of the surgery, history of ocular trauma, irregular corneal astigmatism, pupil abnormalities and capsular or zonular abnormalities that may affect postoperative centration as tilt of the lens (e.g. pseudo exfoliation syndrome and Marfan's syndrome).
Endoscopic Sleeve Gastroplasty for Treatment of Obesity

Emerging endoscopic techniques are minimally invasive and can mimic the anatomic alterations achieved by surgical sleeve gastrectomy.

The study hypothesis is if endoscopic sleeve gastroplasty is effective and useful in the treatment of patients with obesity

The endoscopic sleeve gastroplasty method to perform endoluminal gastric reduction were by a cap-based flexible endoscopic suturing system. Post procedure care includes close follow-up by a nutritionist and a psychologist weekly.The outcome assessment included: change in body weight, percentage of loss of excess body weight and adverse effects

Eligibility Criteria:
Inclusion Criteria:

Obesity Willingness and ability of patients to be treated by a multidisciplinary team for at least 1 year -

Exclusion Criteria:

Prior endoscopy discarded patients with gastric findings (potentially bleeding lesions and neoformative findings ) Coagulopathy Psychiatric disorders

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