cyrilzakka/clinical-trials huggingface dataset:
A Study to Evaluate the Product Performance of a Daily Disposable Contact Lens

The objective of the study is to evaluate the product performance of visual acuity of the Bausch + Lomb investigational daily disposable contact lenses compared to the currently marketed Johnson \& Johnson Acuvue Moist contact lenses.


Eligibility Criteria:
Inclusion Criteria:

* Subjects must be adapted soft contact lens wearers that are interested in daily disposable wear or currently adapted daily disposable soft contact lens wearers.
* Subjects must agree to wear study lenses on a daily disposable basis for approximately one week and crossover to wear another study lens for one week.
* Subjects must be correctable through spherocylindrical refraction to 32 letters (0.3 logMAR) or better (distance, high contrast) in each eye.
* Subjects must have clear central corneas that are free of any anterior segment disorders.
* Subjects must be myopic and require lens correction from -1.00 D to -6.00 diopters (D) in each eye.

Exclusion Criteria:

* Subjects who have worn gas permeable contact lenses within the last 30 days or who have worn polymethylmethacrylate lenses within the last 3 months.
* Subjects with any systemic disease currently affecting ocular health or which in the Investigator's opinion may have an affect on ocular health during the course of the study.
* Subjects using any systemic or topical medications that will, in the Investigator's opinion, affect ocular physiology or lens performance.
* Subjects with an active ocular disease or who are using any ocular medication.
* Subjects who are not correctable to 32 letters (0.3 logMAR) in each eye with soft spherical contact lenses.
* Subjects who currently wear monovision, multifocal, or toric contact lenses.
* Subjects with an ocular astigmatism of 1.00 D or greater in either eye.
* Subjects with anisometropia (spherical equivalent) of greater than 1.00 D.
* Subjects with any grade 2 or greater finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation).
* Subjects with corneal infiltrates, of ANY GRADE, are not eligible.
* Subjects with any "Present" finding during the slit lamp examination (refer to Appendix B for methods of clinical evaluation) that, in the Investigator's judgment, interferes with contact lens wear.
* Subjects with any scar or neovascularization within the central 4 mm of the cornea. Subjects with minor peripheral corneal scarring (that does not extend into the central area), that in the Investigator's judgment, does not interfere with contact lens wear, are eligible for this study.
* Subjects who are aphakic.
* Subjects who are amblyopic.
* Subjects who have presbyopia.
* Subjects who have had any corneal surgery (eg, refractive surgery).
* Subjects who are allergic to any component in the study care products.
A Study of the Effectiveness of Additional Risk Minimization Measures Related to ARAVA® (Leflunomide) in Saudi Arabia

The main objective of this post-authorization safety study is to assess healthcare professionals' awareness, knowledge, and behavior related to receipt and reading of the Direct Healthcare Professional Communication and educational materials for ARAVA® (leflunomide) and of the additional risk minimization measures.


Eligibility Criteria:
Inclusion Criteria:

* Healthcare professionals working only in Saudi Arabia
* For Prescribers: Orthopedics, Internists, Family Physicians, General Practitioners, Dermatologists, Obstetricians/Gynecologists, Immunologists, and Rheumatologists who prescribed leflunomide to women of childbearing potential in the six months preceding the time of the inclusion
* For Prescribers: Physicians or pharmacists who have prescribed or dispensed leflunomide in a pre-specified period of the 6 months leading up to survey completion
* For Pharmacists: Pharmacists (including clinical pharmacists) who have dispensed leflunomide to women of childbearing potential in the six months preceding the time of the inclusion

Exclusion Criteria:

* Healthcare professionals who may have conflicts of interest with the survey (i.e., employed by regulatory bodies or pharmaceutical companies)
* Healthcare professionals (with a relative) involved in leflunomide -related lawsuits or associations for victims of leflunomide syndrome
* Healthcare professionals who are not prescribing leflunomide
* Healthcare professionals who have prescribed or dispensed leflunomide earlier than 6 months before the survey completion

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
Quality of Life Outcomes in Spinal Cord Stimulation

The investigators will be evaluating quality of life outcomes in patients who are undergoing routine spinal cord stimulator implant for uncontrolled pain. Patients will be evaluated pre and post-operatively for quality of life improvements, pain control, and functionality.

This is a prospective cohort study for patients who will be undergoing implantation of spinal cord stimulator for pain. All patient will have implantation done at University Hospital Newark or Newark Beth Israel. The data points that will be collected will be the patient's weight, BMI, and detailed questionnaires regarding disability, activity, quality of life, and depression. The first data set will be taken pre-operatively at the DOC, 90 Bergen Street, suite 8100. Those patients enrolled will have the same data taken again upon subsequent postoperative visits at 3, 6, and 12 months. Being that spinal cord stimulation is a well-documented safe procedure, the investigators do not anticipate any deviation from the standard risks of surgery. With that being said the primary safety endpoint would be if there is an increased complication rate, secondary to the procedure, greater than the current anticipated risk rate. This is a purely observational study. Patients are not being recruited for an intervention but are being recruited during routine clinical practice.

Eligibility Criteria:
Inclusion Criteria:

* Patients with neuropathic pain or axial back pain that is not controlled by oral analgesics, opioids, and has failed conservative management.
* Ages 18-90 with no ethnicity or gender predilections.

Exclusion Criteria:

* Patients who have spinal cord injury, multiple stimulator revisions, DRG stimulators, intrathecal pain pumps, complex regional pain syndrome, previous spinal cord stimulator implant, mechanical instability requiring fusion, myelopathy, psychological condition precluding them from complying with therapy, illegal drug abuse including heroin, cocaine, and illegally obtained prescription pills, or have previously been or are currently involved in litigation for medical malpractice.
A Clinical Study of TQH3821 Tablets in the Treatment of Treated Rheumatoid Arthritis

To evaluate the efficacy and safety of TQH3821 in treated patients with moderate-to-severe active rheumatoid arthritis.


Eligibility Criteria:
Inclusion Criteria:

* Subjects voluntarily participate in this study and sign informed consent;
* Male and female, ≥18 years old and ≤70 years old (subject to the date of signing the informed consent);
* The diagnosis meets the rheumatoid arthritis (RA) classification criteria jointly established by the American College of Rheumatology (ACR) and the European Alliance against Rheumatism (EULAR) in 2010, for at least 3 months ;
* Moderate to severe active RA was defined by the following criteria: joint swelling ≥6 (based on 66 joints), joint tenderness ≥6 (based on 68 joints), Disease activity score 28-C-reactive protein (DAS28-CRP) ≥3.2, and CRP\>10mg/L or erythrocyte sedimentation rate (ESR) \>28mm/h;
* At least 12 weeks of treatment with methotrexate (dose 7.5 to 25 mg/ week) and stable dose (7.5 to 25 mg/ week) ≥4 weeks prior to initial administration of the study drug (oral stable dose methotrexate will be continued as background therapy during the trial);
* The subjects can attend the study visit on time and complete the visit;

Exclusion Criteria:

* 8 weeks before baseline examination, subjects underwent joint surgery or received intraarticular glucocorticoid therapy at the joint sites evaluated in this study;
* Patients with rheumatoid arthritis with joint functional activity grade Ⅳ or confined to a wheelchair or bed;
* Current or previous inflammatory joint diseases other than RA and other autoimmune venereal diseases;
* Patients with lung diseases deemed unsuitable for the study by the investigator;
* Cardiovascular and cerebrovascular abnormalities;
* Abnormal thyroid function;
* Subjects with a history or suspected demyelinating disease of the central nervous system;
* Have any type of active malignant tumor or have a history of malignant tumor;
* Presence of active Mycobacterium tuberculosis (TB) infection or latent TB infection without appropriate treatment;
* Have any acute or chronic active infectious disease;
* There are serious poorly controlled diseases;
* People with active hepatitis, or hepatitis B surface antigen (HBsAg) positive, hepatitis B core antibody (HBcAb) positive + hepatitis B virus (HBV) DNA positive, or hepatitis C virus (HCV) antibody-positive;
* History of human immunodeficiency virus (HIV) infection, or positive HIV serological results at screening, and positive antibodies to treponema pallidum during screening;
* Subjects who had suffered a severe trauma, fracture, or surgical procedure within 8 weeks prior to screening, or who were expected to require major surgical procedures during the study period;
* Female subjects who are pregnant or lactating;
* Those who received live attenuated vaccine within 28 days before the start of treatment, inactivated vaccine within 7 days, or planned vaccination during the study period;
* The subject has any medical condition that may affect oral drug absorption, gastrectomy or gastrointestinal disease of clinical significance.
Long-term Outcome of Triple-vessel Coronary Artery Disease Underwent Three Different Strategies (LOTUS)

The study is to determine the long-term outcome of patients with coronary triple vessels disease (TVD) in the real world of China, by three different treatment strategies: percutaneous coronary intervention (PCI), Coronary artery bypass graft (CABG) or optimal medication therapy (OMT).

About 10,000 participants will be enrolled into this retrospective study. Study coordinators will include both men and women over the age of 18 who had angiographic proved triple-vessel disease in a 15 years long-term. Detailed procedural data will be obtained by the study coordinator and local principal investigator. These data will be entered into the electronic data capture system. Participants will have telephone follow-up interviews conducted by the centralized follow-up center at Fuwai Hospital.

Eligibility Criteria:
Inclusion Criteria:

1. Subject has coronary angiography confirmed triple-vessel disease.
2. Subject is ≥ 18 years of age at the time of inclusion.
3. Subject is willing to comply with all protocol-required follow-up evaluation (patient will be followed during 1 month after hospital to assess any complications and clinical status).

Exclusion Criteria:

1. Subject is participating in another investigational clinical trial that may cause non-compliance with the protocol or confound data interpretation.
2. Female subjects with a positive quantitative or qualitative pregnancy test, in accordance with hospital policy.
3. Subjects with no way contact by telephone for follow-up.
Fragility Fracture Integrated Rehabilitation Management (FIRM)

A number of studies for clinical pathway (CP) after hip fracture have been suggested to improve post-fracture outcome. However, CP is not carried out properly in most countries due to inadequate system and awareness, and lack of interdisciplinary approach among orthopaedists, geriatricians and rehabilitation specialists. Thus, we developed Fragility fracture integrated rehabilitation management (FIRM), a new standardized guideline and the multidisciplinary fragility fracture care based on the clinical rehabilitation pathway and conducted a prospective study to evaluate the effects of FIRM compared to conventional rehabilitation.

The purpose of this prospective study

To develop a standardized fragility fracture integrated rehabilitation management (FIRM) based on the critical rehabilitation pathway for fragility fractures.

1. Standardization of initial evaluation for fall and re-fracture risks before rehabilitation
2. Standardization in initial screening for prevention for common complication after fracture and early diagnosis
3. Evidence based standardization in rehabilitation after fragility fracture
4. Development for safe return to normal daily life

Eligibility Criteria:
Inclusion Criteria:

1. Type of fracture : Femoral neck, intertrochanteric, subtrochanteric fracture
2. Type of surgery : Bipolar hemiarthroplasty, THA, ORIF

Exclusion Criteria:

1. Surgery not for hip fracture, but for infection, arthritis, implant loosening, AVN
2. Femur Shaft fracture, acetabular fracture, periprosthetic fracture, pathologic fracture for tumor
3. Combined multiple fracture (ex. Upper extremity)
4. Revision operation
5. Disagree to participation for clinical trial
6. Severe cognitive dysfunction (Obey command ≤1)
ComCancer: Use of Let's Discuss Health Website by Patients With Prostate Cancer Undergoing Radiation Oncology Treatment

In Canada, the prevalence of cancer is growing and contributes significantly to health costs. The prevention and treatment of cancer is a major concern of our health system. Many men with prostate cancer develop psychological distress. The emotional consequences of a cancer diagnosis and its treatments can prevent patients from communicating effectively with their healthcare team. It is recognized that the quality of communication between cancer patients and their caregivers plays an important role in the management of their disease. However, few tools are being developed to help clinicians and patients better communicate and decrease patients' psychological distress. Let's Discuss Health (www.discutonssante.ca) is a French-language website that offers several tools to support collaboration between caregivers and cancer patients.

The objectives of this research project are to assess the experience of using the Let's Discuss Health website and the impact of its use on the quality of communication between radiation oncologists and patients, the level of distress of patients with prostate cancer, recall of the information discussed as well as adherence to the trajectory in radiation oncology.

The project will take place in three radiation oncology centers in Quebec. Two groups of prostate cancer patients will be recruited. Patients in the first group will be assessed on the basis of regular consultations and those in the second group will be encouraged to prepare for their medical visits using the Let's Discuss Health website. Patients and their caregivers will answer short questionnaires before and after four targeted consultations (initial visit, mid-treatment visit, end-of-treatment visit and 3-month post-treatment visit). Focus groups will also be organized to explore the impact of the website.

This project offers the potential to transform clinical practices in radiation oncology to reduce the burden of cancer and improve the quality of care offered to patients with cancer.


Eligibility Criteria:
Inclusion Criteria:

* have a diagnosis of prostate cancer
* understand, speak and read French
* report being comfortable using the Internet
* have access to a computer, tablet or smartphone or know someone who does and is willing to accompany them

Exclusion Criteria:

* being considered unfit to give free and informed consent (e.g. dementia, severe psychiatric condition)
* any other clinical reason (poor health of the patient at the time of the consultation) that the clinician deems relevant
Extracorporeal Shock-wave Therapy for Supraspinatus Calcifying Tendonitis: a Randomized Clinical Trial Comparing Two Different Energy Levels

The purpose of this study is to compare two different ranges of energy flux density with Extracorporeal Shock Wave Therapy in treatment of supraspinatus calcifying tendonitis.


Eligibility Criteria:
Inclusion Criteria:

* no visible clinical benefits by previous conservative treatment
* medium and large calcific deposits, according to Bosworth classiﬁcation
* type I and II Gartner deposits

Exclusion Criteria:

* presence of tiny calcific deposits, according to Bosworth classiﬁcation
* type III, according to the Gartner classification
* age (if less than 18 years old), diabetes, coagulation diseases or anticoagulant therapy, tumors, bone infections, previous shoulder surgery, pregnancy, pace-maker, acute bursitis demonstrated by ultrasound imaging, rheumatoid arthritis or other connective tissue diseases
Multicenter Automatic Defibrillator Implantation Trial - Reduce Inappropriate Therapy

This study will assess the impact of higher rate cutoffs and longer delays than standard programming on inappropriate therapy in primary prevention ICD and CRT-D patients.

The purpose of the MADIT-RIT trial is to compare the time to first inappropriate therapy using high rate cutoff and/or long delay in primary prevention patients receiving an ICD or CRT-D device compared to standard programming.

Eligibility Criteria:
Inclusion Criteria:

* Primary prevention patient with ischemic or non-ischemic heart disease who meets current guidelines for dual-chamber ICD or CRT-D device therapy
* Patient in sinus rhythm
* Patient on stable optimal pharmacologic therapy for the cardiac condition or who has developed a recent ICD indication that necessitates ICD therapy concurrent with the optimization of pharmacologic therapy
* Patient ≥ 21 years of age, or legal representative, willing and capable of giving informed consent

Exclusion Criteria:

* Patient with an implanted pacemaker or CRT-P
* Patient with existing ICD or CRT-D device components
* Patient with a history of VT or VF
* Patient with permanent or chronic AF, or cardioversion for AF, within the past three calendar months before enrollment
* Patient with coronary artery bypass graft surgery or percutaneous coronary intervention within the past three calendar months prior to enrollment
* Patient with enzyme-positive myocardial infarction within the past three calendar months prior to enrollment
* Patient with angiographic evidence of coronary disease who are candidates for coronary revascularization and are likely to undergo coronary artery bypass graft surgery or percutaneous coronary intervention in the foreseeable future
* Patient with second or third degree heart block
* Patient in NYHA Class IV
* Patient who is pregnant or plans to become pregnant during the course of the trial
* Patient with irreversible brain damage from preexisting cerebral disease
* Patient with presence of any disease, other than the patient's cardiac disease, associated with a reduced likelihood of survival for the duration of the trial, e.g., cancer, uremia, liver failure, etc.
* Patient with chronic renal disease with BUN ≥ 50mg/dl or creatinine ≥ 2.5 mg/dl
* Patient participating in any other clinical trial
* Patient unwilling or unable to cooperate with the protocol
* Patient who lives at such a distance from the clinic that travel for follow-up visits would be unusually difficult
* Patient who does not anticipate being a resident of the area for the scheduled duration of the trial
* Patient unwilling to sign the consent for participation
* Patient whose physician does not allow participation
Applicability of Home-based Exercise Programs in Physiotherapy

Aim: In this study, the types of home-based exercise programs prepared for patients receiving physiotherapy services in different rehabilitation institutions; It is aimed to examine the applicability and effectiveness advantages according to disease status, age, gender, socioeconomic level, education level, confidence in the home program, and functional independence level.

Study type: observational study Research question; To what extent do patients participate in home-based exercise programs?

Background and rationale; It is common to use home exercise programs in organizations that provide physiotherapy services. The home exercise program is specially created by physiotherapists according to the patient's needs and individual characteristics. The prepared program is explained to the patient how to do the exercise at home by various means such as verbal explanation, practical demonstration, giving brochures or video recording. Home program exercises contribute positively to the rehabilitation process by enabling the patient to take an active role in the rehabilitation process and giving the patient personal responsibility. Supporting the treatments given in health institutions with home program exercises increases the effectiveness of the treatment. In addition, preparing a home exercise program is a frequently used method in cases where access to healthcare is difficult due to various reasons.

Aim: In this study, the types of home-based exercise programs prepared for patients receiving physiotherapy services in different rehabilitation institutions; It is aimed to examine the applicability and effectiveness advantages according to disease status, age, gender, socioeconomic level, education level, confidence in the home program, and functional independence level.

Research processes; Participants will first be interviewed face to face and preliminary evaluation data will be obtained before a home exercise program is given.

The patient's gender, age, diagnosis, education level, socioeconomic level, functional dependency level, state anxiety level, fatigue severity scale, and pain level score will be recorded. The type of exercise given and the type of learn home-based exercise will be recorded.

12 days after the routine home exercise program, the final data will be collected by the researchers from the patients face to face or by phone for patients who cannot attend the appointment.

Eligibility Criteria:
Inclusion Criteria:

* Having a clinical problem that causes physiotherapy and rehabilitation treatment
* Being able to understand Turkish

Exclusion Criteria:

* Not wanting to participate in the study
* Having a chronic disease or disability that would prevent the application of the home program.
Pulsed Dye Laser in Treating Superficial Basal Cell Carcinomas

Pulsed dye laser (PDL) treatments have been suggested to be a safe and effective therapeutic approach for treating basal cell carcinomas. Robust supporting evidence is, however, lacking due to inconsistent design of available studies. The purpose of this study is to evaluate the PDL's efficacy and safety in treating superficial basal cell carcinoma (sBCC) at low risk anatomical sites in an evidence based study setting.


Eligibility Criteria:
Inclusion Criteria:

* histologically confirmed unpigmented sBCC on the trunk and extremities
* maximal tumour diameter 30 mm

Exclusion Criteria:

* Fitzpatrick skin type \>III
* pregnancy
* previous BCC treatment within 4 weeks
* coagulation disorders
* photo sensitizing medication
* any indication of poor compliance