cyrilzakka/clinical-trials huggingface dataset:
Perceptions of Ophthalmologists Regarding Contemporary Presbyopia Management.

Different attitudes and perceptions are encountered concerning contemporary presbyopia management. Exploration of ophthalmologists' attitudes on diagnostic and therapeutic management of presbyopia is essential for the development of disease management interventions by the Hellenic Ministry of Health and Welfare. Within this context, Greek ophthalmologists' perceptions on presbyopia will be explored by means of a custom questionnaire.

Different attitudes and perceptions are encountered concerning contemporary presbyopia management. Exploration of ophthalmologists' attitudes on diagnostic and therapeutic management of presbyopia is essential for the development of disease management interventions by the Hellenic Ministry of Health and Welfare. Within this context, Greek ophthalmologists' perceptions on presbyopia will be explored by means of a custom questionnaire (DePrePer31).

Eligibility Criteria:
Inclusion Criteria:

* Valid license to practice ophthalmology in European Union.
* Adequate literacy of Greek language.

Exclusion Criteria:

* Pediatric ophthalmologist.
VISN 23 Chronic Obstructive Pulmonary Disease (COPD) Case Management Using Home Telehealth Equipment

Looking at the use of home telehealth equipment and it's place in self management and education in patients who suffer moderate to severe Chronic Obstructive Pulmonary Disease (COPD). The patients in this group would be those patients who traditionally suffer from emphysema, and/or chronic bronchitis.

Patients who have been admitted to the hospital, or who have frequent urgent care visits, who also suffer from COPD exacerbations will be given a home monitoring system. Daily, the patient will respond to a series of questions. The results of the question answers will be remotely monitored by a nurse case manager.

The objective is to measure compliance, resource use, and the ability for early recognition of an exacerbation of their COPD, and early implementation of therapy.

Eligibility Criteria:
Inclusion Criteria:

* One or more hospital admissions or emergency room visits in last 2 Years.
* Patient must meet the VA home telehealth guideline that the patient is determined to be at high risk for poor clinical outcomes or increased unplanned health care utilization based on disease specific criteria and/or determined by physician provider

Exclusion Criteria:

* Any unstable medical condition that the investigator thinks would preclude effective participation in the study, or which would be expected to reduce life expectancy to less than 1 year.
* Unwilling or unable to provide consent
* Uncooperative or combative
* Does not have a compatible phone line
* Inability to use home telemedicine equipment
CYC065 CDK Inhibitor and Venetoclax Study in Relapsed/Refractory AML or MDS

A Phase I Combination Study of CYC065 and Venetoclax for Relapsed or Refractory AML or MDS

This is an open-label, single arm, dose escalation study in patients with relapsed or refractory AML or MDS. Treatment will be administered on an outpatient basis and all patients will receive CYC065 over 4-hour infusion once every 2 weeks on Day 1 and Day 15 in combination with venetoclax. One treatment cycle is 4 weeks.

Eligibility Criteria:
Inclusion Criteria:

* Previously treated AML or MDS based on WHO classification and having at least 10% blasts in peripheral blood
* ECOG 0-2
* Adequate renal function
* Adequate liver function
* INR \<=1.2 in patients not receiving chronic anticoagulation
* At least 2 weeks from prior cytotoxic chemotherapy, radiation therapy, major surgery or other investigational cancer therapy
* Agree to practice effective contraception

Exclusion Criteria:

* AML is of the subtype of APL or extramedullary myeloid tumor without bone marrow involvment
* Known AML involvement in CNS that is symptomatic and active
* Currently receiving radiotherapy, biological therapy, or any other investigational agents
* Uncontrolled intercurrent illness
* Pregnant or lactating
* Known to be HIV-positive
* Known active hepatitis B and/or hepatitis C infection
Addressing Emotional and Cognitive Factors in Behavioral Weight Loss Treatment (Part 2)

Behavioral weight loss, the current treatment of choice for moderate obesity, achieves impressive short term results, however, weight regain following treatment is a major problem. Over 50% of participants in behavioral weight loss programs report difficulty with internal antecedents to unhealthy weight control behaviors and this difficulty is associated with weight regain following treatment. Current treatment approaches do not adequately address these antecedents. The aim of this series of studies is to develop, implement, and evaluate a behavioral weight loss program modified to provide participants with skills to deal effectively with affective and cognitive difficulties. The study targets men and women with BMI of 27-40 who self-report difficulty with emotional and/or cognitive antecedents to unhealthy weight control behaviors. The study will randomize 120 participants to receive 12 months of standard behavioral therapy for weight loss or standard behavioral treatment plus affective and cognitive skills training. The long-term goal of this research is to improve the weight loss maintenance outcomes of behavioral weight loss programs by addressing affective and cognitive antecedents to unhealthy weight control behaviors.


Eligibility Criteria:
Inclusion Criteria:

* Age between 21 and 70 years
* Body mass index between 27 and 40
* Score 5 or above on the internal disinhibition scale of the Eating Inventory

Exclusion Criteria:

* Are currently participating in a weight loss program and/or are taking a weight loss medication or lost greater than or equal to 5% of body weight during the past six months
* Are pregnant, lactating, less than 6 months postpartum or plan to become pregnant during the time frame of the investigation
* Report a heart condition, chest pain during periods of activity or rest, or loss of consciousness on the Physical Activity Readiness Questionnaire (PAR-Q). Individuals endorsing joint problems, prescription medication usage, or other medical conditions that could limit exercise will be required to obtain written physician consent to participate.
Safety and Efficacy Study of JTT-705 in Combination With Atorvastatin 20 mg in Patients With Low High-Density Lipoprotein (HDL) Levels

The purpose of this study is to evaluate safety of JTT-705 and to demonstrate efficacy of JTT-705 compared with placebo when co-administered with atorvastatin 20 mg in patients with low HDL


Eligibility Criteria:
Inclusion Criteria:

* Patients having lipid values as indicated below:
* HDL-C ≤ 1.0 mmol/L (40 mg/dL)
* TG ≤4.5 mmol/L (400 mg/dL)
* Patients with CHD or CHD risk equivalent
* Male and females between 18 and 70 years of age (female patients must be post-menopausal, surgically sterile or using an acceptable form of contraception)

Exclusion Criteria:

* Body Mass Index of ≥ 35 kg/m2
* Females that are pregnant or breast-feeding, and females of child bearing potential who are not using an effective method of contraception
* Concomitant use of medications identified in the protocol
The Mindfulness-Based Psycho-Educational Program Focused on Emotion Regulation Strategies

In this study, the effects of a mindfulness-based emotion-focused psychoeducation program applied to individuals diagnosed with schizophrenia on emotion regulation difficulties, depressive symptoms, and hope levels will be examined. The research will be carried out as a randomized controlled experimental study with a pre-test-post-test and follow-up design.

Schizophrenia is a chronic illness that begins at a young age and leads to impairments in thought, perception, and affect. Patients experience a loss of functionality in occupational, social, and personal areas and face emotional challenges such as depression, anxiety, and hopelessness. Difficulties in emotion regulation are common among individuals with schizophrenia, making disease management more challenging.

Emotion regulation refers to the process of recognizing, accepting, and managing emotions using appropriate strategies. Literature indicates that difficulties in emotion regulation among individuals with schizophrenia are associated with depression and an increased risk of suicide. Mindfulness-based interventions have been found effective in enhancing emotion regulation skills and reducing depressive symptoms, rumination, and hallucinations.

This study aims to examine the effects of a mindfulness-based psychoeducation program for individuals diagnosed with schizophrenia on emotion regulation difficulties, depressive symptoms, and levels of hope. The findings are expected to contribute to nurse-led interventions that support the mental health and rehabilitation process of patients.

Eligibility Criteria:
Inclusion Criteria:

1. Being diagnosed with schizophrenia according to DSM-5 diagnostic criteria
2. Being between 18-65 years old
3. Not having any problems with communication
4. Being literate
5. Being willing to participate in the research
6. Having schizophrenia for at least 2 years

Exclusion Criteria:

1. Having a neurological disease
2. Having a neurocognitive disease
3. Having comorbid depression according to DSM-5 diagnostic criteria
4. Being a substance abuser
5. Having participated in and currently receiving a structured psychotherapeutic intervention program within the last year
Non-invasive Prediction of Fluid and Noradrenaline Responsiveness Using the Carotid Wave Intensity.

The goal of this observational study is to study a new method to compute ventricular-arterial coupling (VAC) in adult intensive care patients after cardiac surgery. VAC is a metric that describes the interaction between the heart and the arterial system. The new method of measuring VAC uses carotid ultrasound measurements. The main questions this study aims to answer are:

* Can VAC measured using carotid ultrasound predict the hemodynamic response to drugs?
* What is the concordance of VAC measurements obtained via carotid ultrasound with VAC measurements obtained via the standard, single-beat method? Measurements will be performed in the operating room and at the ICU.

The goal of this prospective observational study is to study ventricular-arterial coupling (VAC) measured using carotid ultrasound in adult intensive care patients after cardiac surgery. The objectives of this study are:

* To determine if VAC measured using carotid ultrasound can predict the hemodynamic response to drugs.
* To assess and quantify the concordance of VAC measurements obtained using carotid ultrasound with VAC measurements obtained using the single-beat method.

Measurements will be performed in the operating room and at the ICU.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (≥18 years)
* Admitted to the ICU after cardiac surgery

Exclusion Criteria:

* No informed consent for study participation
* Within the first 3 hours of ICU admission noradrenaline infusion is not increased or started, and/or a fluid bolus is not given; both on indication of the attending physician
* Patient with chronic obstructive pulmonary disease (COPD) gold stage 3 or 4
* Pregnancy
* Moderate to severe aortic valve disease
* Atrial fibrillation
* Carotid artery stenosis \>50%
* History of cerebrovascular accident or transient ischemic attack
* History of cerebral trauma
* Morbid obesity (BMI \>40 kg/m2)
* Emergency surgery
Comparative Trial Evaluating Safety and Immunogenicity of an Adjuvanted and a Conventional Influenza Vaccine in Elderly Subjects (> 60 Years)

Clinical Trial in Two parts:

Part 1: Phase I, Open-Label, Single-Center Study to Evaluate the Safety of an adjuvanted Influenza Vaccine When Administered to Elderly Subjects.

Part 2: A Phase III, Randomized, Controlled, Observer-blind, Single-Center Study to Evaluate the Immunogenicity and Safety of an adjuvanted and a conventional Influenza Vaccine When Administered to Elderly Subjects.


Eligibility Criteria:
Inclusion Criteria:

* Subjects 60 years of age or older, mentally competent, willing and able to give the written informed consent prior to study entry

Exclusion Criteria:

* Any serious disease such as: cancer, autoimmune disease, advanced arteriosclerotic disease or complicated diabetes mellitus, chronic obstructive pulmonary disease (COPD) that requires oxygen therapy, acute or progressive hepatic disease, acute or progressive renal disease, congestive heart failure.
* Hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the vaccine.
* History of neurological symptoms or signs, or anaphylactic shock following administration of any vaccine.
* Known or suspected (or have a high risk of developing) impairment/alteration of immune function (excluding that normally associated with advanced age).
The Relationship Between Disease Severity and Various Lower Extremity Parameters in Individuals With Knee Osteoarthritis

This study perform to investigate the relationship between quadriceps femoris (QF) strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee osteoarthritis.

Osteoarthritis (OA) is one of the most common chronic degenerative diseases in the world, which progresses slowly, can cause pain, stiffness and dysfunction, and reduces the quality of life.

OA is particularly common in weight-bearing joints such as the knee and the functional status of patients with OA is adversely affected various factors such as immobility due to pain, decrease in muscle strength and joint range of motion, etc.

In relation to this, walking difficulty and decrease in walking speed, balance problems and an increase in the risk of falling are a picture that can be encountered in the later stages of the disease.

The aim of this study is to investigate the relationship between QF strength, QF thickness, femoral cartilage thickness, knee function, balance, kinesiophobia and gait of the patients with knee OA.

Eligibility Criteria:
Inclusion Criteria:

* Volunteer patients who applied to the Physical therapy and Rehabilitation department with knee pain

Exclusion Criteria:

* Individuals who have received intra-articular therapy for gonarthrosis in the last 6 months, who have undergone arthroscopic surgery, and who have additional pathologies in their lower extremities
* Individuals with physical, mental and/or psychological disorders that may affect participation in the study
Adalimumab Plus Methotrexate for the Treatment of Pediatric Uveitis

The aim of this study is to determine the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis.

Although non-infectious uveitis is rare in pediatric population, the irreversible visual impairment due to ocular complications, severe drug adverse effects are disturbing. There is a high rate of chronic disorder of ocular inflammation and unresponsiveness of therapy drugs in pediatric uveitis, which result in structure destruction and functional impairment including band keratopathy, posterior synechiae, cataract, and so on. The systemic and topical glucocorticoid are advocated to control inflammation but carry a high risk of lots of advert events.

Methotrexate is now highly recommended to control uveitis and most commonly prescribed in pediatric uveitis. it was benefit to prolong remission and reduce recurrence. However, despite early intervention 27-48% children do not achieve control of inflammation and 20% experience adverse events. Adalimumab, a fully human anti-tumor necrosis factor α monoclonal antibody, is effective in the treatment of many rheumatic diseases. ADA as the initial treatment in adult patients of uveitis lead to a more optimistic prognosis, a better visual acuity and a lower dose of dosage of daily glucocorticoid.

The investigators propose to test the efficacy and safety of ADA plus MTX for the treatment in non-infectious pediatric panuveitis who were followed up for 1 year.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of non-infectious panuveitis
* Age from 2 to 16 years old
* Vision threatening non-infectious uveitis hadn't received standardized systematic treatment before

Exclusion Criteria:

* Patients who had active infection (including hepatitis B or C infection, tuberculosis), malignancy diseases, or bilateral irreversible blindness and any other contraindications of ADA
* previous exposure to another biologic agent
Warfarin and Non-Steroidal Anti-Inflammatory Drugs (NSAID) Customized Alert

The hypothesis is that a newly formatted electronic alert that requires the prescriber to pause and enter a specific "reason for override" on this alert, will cause prescribers in the intervention group to be significantly less likely to prescribe the combination of warfarin and NSAID than prescribers in the control group.


Eligibility Criteria:
Inclusion Criteria:

* All resident physicians (RP) and nurse practitioners (NP) involved in inpatient care at two hospitals of the University of Pennsylvania

Exclusion Criteria:

* None
Management Of The Infusion-Associated Reactions In RRMS Patients Treated With LEMTRADA

Primary Objective:

To assess the distribution of IARs by severity grade when LEMTRADA is administered to RRMS patients who will be medicated according to specified algorithm designed to manage infusion associated reactions.

The total duration of participation in the study per patient is approximately 13.5 months.

After the end of the second course of LEMTRADA treatment, patients will be followed by their physician in a regular healthcare setting until 48 months safety monitoring period is completed.

Eligibility Criteria:
Inclusion criteria:

* Adult RRMS patients who will be initiating treatment with Lemtrada according to local approved label.
* Signed written informed consent.

Exclusion criteria:

* Previously treated with LEMTRADA.
* Contraindications to LEMTRADA according to the labeling in the country.
* Any known contraindications to the symptomatic therapy used in the infusion management guidance based on their local approved label.
* Currently participating in another investigational interventional study.
* Any technical/administrative reason that makes it impossible to enroll the patient in the study.
* Patient is the Investigator or any Sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol.
* Patient who has withdrawn consent before enrollment (starting from signed informed consent form).
* Despite screening of the patient, enrolment is stopped at the study level.
* Woman of childbearing potential not protected by highly-effective method(s) of birth control (as defined in a local protocol amendment in case of specific local requirement) and/or who are unwilling or unable to be tested for pregnancy.
* Pregnancy (defined as positive beta human chorionic gonadotropin (β-HCG) blood test), breast feeding.
* Known infection with latent tuberculosis or active tuberculosis.
* Known infection with Hepatitis B, Hepatitis C.

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
A Safety and Tolerability Study of VC-02™ Combination Product in Subjects With Type 1 Diabetes Mellitus

The purpose of this trial is to test if VC-02™ combination product can be implanted subcutaneously in subjects with Type 1 Diabetes and maintained safely for up to four (4) months.


Eligibility Criteria:
Inclusion Criteria:

* Men and non-pregnant women of non-childbearing potential
* Diagnosis of T1DM for a minimum of five (5) years
* Stable diabetic treatment
* Willingness to use a continuous glucose meter
* Acceptable candidate for implantation

Exclusion Criteria:

* History of islet cell, kidney, and/or pancreas transplant.
* Two (2) or more severe, unexplained hypoglycemic events within six (6) months of enrollment
* Uncontrolled or untreated thyroid disease or adrenal insufficiency
* Diabetic complications such as severe kidney disease or renal dysfunction, proliferative retinopathy, diabetic foot ulcers, amputations attributable to diabetes, and/or severe peripheral neuropathy
* Non-compliance with current anti-diabetic regimen
Automatic Remifentanil Administration Guided by ANI During Propofol Anesthesia

Prospective Randomized Monocentric Clinical Trial during propofol anesthesia. The aim of the study is to test whether the use of a medical device designed to automatically administer remifentanil during surgery based on expert rules and continuous reading of heart rate, blood pressure and the Analgesia Nociception Index results in lower overall remifentanil administration versus standard practice.

Prospective Randomized Monocentric Clinical Trial during propofol anesthesia.

* inclusion: ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery in a Burn Center (University Hospital of Lille, France)
* arm 1 : Remifentanil will be automatically administered by an expert system guided by heart rate, blood pressure and the Analgesia Nociception Index (ANI).
* arm 2 : Remifentanil will be administered by a target controlled device using the Minto pK/pD model.
* propofol is administered throughout the procedure with a target controlled device using the pK/pD model of Schnider. The target will be guided by the BiSpectral index values.
* primary endpoint : overall normalized remifentanil administration.
* secondary endpoints : relative amount of time spent in a state of hemodynamic reactivity ; relative amount of time the ANI spends in the \[0-50\], \[50-70\] and \[70-100\] windows ; relative amount of time the BIS spends in the \[0-40\], \[40-60\] and \[60-100\] ; hemodynamic status at various times during anesthesia ; total amount of target modifications of remifentanil and propofol ; total amount of morphine administered in PACU ; total amount of ketamine administered in PACU ; incidence of nausea/vomiting in PACU ;

Eligibility Criteria:
Inclusion Criteria:

* ASA 1, 2 or 3 adult patients scheduled to undergo burn wound surgery at the Burn Center of the University Hospital of Lille

Exclusion Criteria:

* BMI outside \[17 - 35 kg/m2\]
* pregnancy or breast feeding women
* non sinus cardiac rhythm
* documented dysautonomia
* complicated diabetes mellitus
* known allergy to a drug used in the clinical trial
Intra-nasal Ketamine for Analgesia in the Emergency Department

The provision of analgesia to patients in pain is a fundamental necessity of emergency department practice and is usually accomplished using IV opioids. However, significant barriers exist to the provision of timely analgesia by the IV route.

The use of the IN route for medication delivery provides an efficient and relatively painless mode of analgesia delivery. As well, ketamine is well-known to be an effective analgesic and to preserve cardiorespiratory function thus removing the necessity of physiologic monitoring that is obligatory when using opioids. The use of ketamine by the IN route provides a rapid, easy-administered and well-tolerated method for providing analgesia in the ED setting.


Eligibility Criteria:
Inclusion Criteria:

* age 6 years or greater
* moderate or severe pain (VAS \>=50mm)

Exclusion Criteria:

* history of allergy or intolerance to ketamine
* structural or functional nasal occlusion
* inability to understand the VAS
* Glasgow Coma Scale \< 15
* Systolic BP \> 180
* History of schizophrenia
* Clinical necessity for immediate IV access as judged by the treating physician