cyrilzakka/clinical-trials huggingface dataset:
Phase 1 TAK-915 Single-Dose Positron Emission Tomography (PET) Occupancy Study

This phase 1 study will be conducted to examine the degree and duration of brain PDE2A enzyme occupancy /target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia with TAK-915.

The drug being tested in this study is called TAK-915. TAK-915 is being tested to examine the degree and duration of brain phosphodiesterase 2A (PDE2A) enzyme occupancy/target engagement as a function of TAK-915 plasma concentration in order to guide dosing and schedule for future clinical studies in schizophrenia. This study will look at PDE2A brain enzyme occupancy in the putamen as a function of TAK-915 plasma concentration, as assessed using the positron emission tomography (PET) ligand \[18F\]MNI-794 after single dosing of TAK-915.

The study will enroll approximately 16 patients in total and within that total, allow up to 5 dose levels and up to 6 subjects per dose level. All participants will receive a single dose of TAK-915 on Day 1. The initial TAK-915 dose level to be studied is 100 mg. Subsequent dose levels may be lower or higher and will be determined through dose level review meetings (DLRMs) following approximately every 2 participants and based on prior occupancy, duration of occupancy, safety, tolerability, and available pharmacokinetic (PK) data.

This single center trial will be conducted in the United States. The overall time to participate in this study is up to 55 days. Participants will make multiple visits to the clinic, and will be contacted by telephone 22 days after last dose of study drug for a follow-up assessment.

Eligibility Criteria:
Inclusion Criteria:

1. Is a healthy male, or female of non-childbearing potential, aged between 18 and 55 years, inclusive.
2. Weighs at least 45 kg and has a body mass index (BMI) between 18.0 and 30.0 kg/m\^2.

Exclusion Criteria:

1. Has a known history or evidence of a clinically significant disorder (including neurologic and psychiatric) or disease that in the opinion of the study investigator would pose a risk to the participant's safety or interfere with the study evaluation, procedures, or completion.
2. Contraindication to magnetic resonance imaging (MRI) based on the standard MRI screening questionnaire.
3. Have had exposure to any radiation \>15 millisievert (mSv)/year (eg, occupational or radiation therapy) within the previous year prior to Baseline imaging.
4. Has a known hypersensitivity to any component of the formulation of TAK-915 or related compounds, or to \[18F\]MNI-794 or to any of its components.
5. Clinically significant abnormal findings on brain MRI scan or findings on brain MRI that may interfere with the interpretation of the positron emission tomography (PET) imaging.
6. Use of any herbal or prescription medications within 30 days prior to Baseline Imaging Check-in; use of any over-the-counter medications or vitamin supplements within 7 days prior to Baseline Imaging Check-in.
Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia

The purpose of this study is to evaluate Efficacy and Safety of Generic Imatinib (Carcemia®) Compared to Glivec® in Real-Life Management of Chronic Phase of Chronic Myeloid Leukemia

This is an observational, prospective, cohort study design, where no visits or intervention(s) additional to the daily practice will be performed. In the study site, two cohorts will be identified among eligible patients, followed up, and assessed for a total of 12 months.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥18 years
2. Newly diagnosed patients with Ph+ CML in CP, with or without the presence of other cytogenetic abnormalities at the time of diagnosis
3. Treatment naïve patients with confirmed diagnosis within 3 months of study enrolment
4. Levels of liver aminotransferases and serum bilirubin ≤ 2 times the upper limit of the normal range, and serum creatinine ≤1.5 times the upper limit of the normal range
5. Written informed consent

Exclusion Criteria:

1. CML in accelerated phase (AP) at enrolment except patients in AP with the presence of other cytogenetic abnormalities at the time of diagnosis 2. CML in BP at enrolment 3. Patients who meet any of the contraindications to the administration of the study drug according to the approved Summary of Product Characteristics.

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The StUdy to Evaluate the Performance and safEty of the Novasight HybRid System Using Objective PeRformance Criteria

This prospective, multicenter, single-arm study aims to evaluate the safety, operability and practicability of the novel hybrid intravascular imaging system/catheter during the percutaneous transluminal coronary intervention.


Eligibility Criteria:
Inclusion Criteria:

1. Subject must be at least 18 years of age and less than 85 years of age.
2. Subject must be informed and sign a written consent
3. Subject must have evidence of myocardial ischemia, unstable angina or acute myocardial infarction suitable for PCI.

Exclusion Criteria:

1. Women who are pregnant or cannot eliminate the possibility to be pregnant.
2. Estimated creatinine clearance \<30 ml/min/1.73 m2 using Cockcroft equation.
3. LVEF(Left ventricular ejection fraction) \< 35% by the most recent imaging test within 7 days prior to procedure.
4. Unstable ventricular arrhythmias.
5. High bleeding risk, active peptic ulcers or cerebrovascular accident or transient ischemic attack within the past 6 months.
6. Known contraindication to anticoagulants and antiplatelets therapy.
7. Known hypersensitivity to aspirin, clopidogrel, heparin, iodinated contrast, ticagrelor, bivalirudin, metal materials in stent.
8. Any intervention for not target vessel within 48 hours after the study procedure.
9. Any conditions that, in the investigator's opinion, could limit the subject's ability to participate in the clinical investigation.

Angiographic exclusion criteria:

1. The reference diameter of target vessel is less than 2.5 mm.
2. The target lesion involves myocardial bridge.
3. The target lesion is in the left main coronary artery or the damage is observed in the ostium.
4. Severe calcification in the target vessel.
5. Severe tortuosity in the target vessel.
6. Multiple contiguous stent implantation in the target vessel.
7. Subject has coronary artery spasm.
8. In-stent restenosis.
9. Any study lesion characteristic that, in the investigator's opinion, is not available for intravascular imaging.
Effects of Two Different Exercise Practices on Maximum Oxygen Uptake and Pulmonary Function

Cardiopulmonary capacities of individuals are an indication of both the individual's exercise capacity and endurance. The most important indicator of cardiopulmonary capacity is maximum oxygen uptake and respiratory parameters. Auxiliary respiratory muscles exercises and core stabilization exercises have a place in increasing the maximum oxygen uptake. There are studies investigating the effects of respiratory muscle training and core stabilization training on maximum oxygen uptake in the literature. However, there is no study in the literature comparing the effects of auxiliary respiratory muscles exercises and core stabilization exercises on maximum oxygen uptake and respiratory parameters. Thanks to the findings to be obtained from our study, it is aimed to contribute to the literature with objective, evidence-based results in this field.

The study will be carried out on volunteers after the approval of the ethics committee. Before the research, individuals and / or their relatives will be informed about the purpose and content of the study. Volunteer individuals between the ages of 18-25 without any known health problems will be included in the study after obtaining their informed consent.

Participants will be randomly divided into three groups: control group, core stabilization exercises and auxiliary respiratory muscles exercises.

In the core stabilization exercises and auxiliary respiratory muscles exercises groups, exercises will be carried out under the supervision of a physiotherapist 3 days in a week separate time periods. Core stabilization exercise include, plank, lateral plank, swimmer, flutter kick and bridge exercises. Auxiliary respiratory exercises include, strengthening and stretching exercises for trapezius, sternocleidomastoideus, pectoralis major and serratus anterior muscles. Our study will take 6 weeks. The demographic information of the participants will be recorded and the VO2max values of the participants before and after the study will be measured with the H / P Cosmos Mercury Med device using the balke protocol. Respiratory function tests of participants will be measured with Cosmed Fitmate Med device before and after the study.

Eligibility Criteria:
Inclusion Criteria:

* Healthy individuals without any known health problems

Exclusion Criteria:

* Acute myocardial infarction, Unstable angina, Uncontrolled cardiac arrhythmias, Endocarditis, Various symptomatic aortic stenosis, Acute pulmonary embolism, pulmonary infarction and deep vein thrombosis, Acute myocarditis, pericarditis, physically not enough fit to test safely
A Comparison of Hydrogel Dressings and Ocular Lubricants in the Prevention on Corneal Damage in the Critically Ill

Corneal damage in critically ill patients is common. There are currently two popular methods of treatment in the UK; hydrogel dressings and lubricating ointment. We propose to randomise patients to have a different treatment for each eye and see which one is more effective.

Microbial keratitis, particularly pseudomonas-related, has been widely reported amongst Intensive therapy unit (ITU) patients and the need for effective eye care in ITU has been recognised for some time. We compare two popular methods of eye care; a hydrogel dressing and lacrilube ointment. Each recruited patient had each eye randomised to different treatments. Daily ophthalmology ward rounds were undertaken to identify any corneal exposure keratopathy. Patients were removed from the trial if one eye developed significant exposure needing treatment.

Eligibility Criteria:
Inclusion Criteria:

* All patients admitted to Intensive care and expected to stay for more than 2 days

Exclusion Criteria:

* Primary orbital injury
Evaluation of the Ulthera™ System for Obtaining Lift and Tightening of the Cheek Tissue

The clinical trial evaluates the clinical outcomes associated with the non-invasive treatment to obtain lift and tightening of the cheek tissue and improve jawline definition and submental skin laxity utilizing the Ulthera™ System which delivers ultrasound energy in a focused manner below the surface of the skin

The primary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment to obtain lift and tighten the cheek tissue.

The secondary objective of this study is to demonstrate the effectiveness of the Ulthera™ System for the non-invasive dermatological treatment for improvement in jawline definition and submental skin laxity at 3 and 6 months compared to baseline based on the consensus of the three masked reviewers.

Eligibility Criteria:
Inclusion Criteria:

* Male or female, aged 35 to 60 years
* Subject in good health
* Desire lift and tightening of cheek tissue, improvement of jawline definition or submental skin laxity

Exclusion Criteria:

* Pregnant or lactating
* Has an active systemic or local skin disease that may alter wound healing
* Severe solar elastosis
* Excessive subcutaneous fat on the cheeks
* Excessive skin laxity on the lower face and neck
* Has significant scarring in areas to be treated
* Has significant open facial wounds or lesions
* Has severe or cystic acne on the face
A Trial of SK-PC-B70M in Mild to Moderate Alzheimer's Disease

The purpose of this study is to find optimistic dose and to evaluate the efficacy and safety of SK-PC-B70M in patients with mild to moderate Alzheimer's disease.


Eligibility Criteria:
Inclusion Criteria:

* Age range : 50 \~ 85 years
* Clinical diagnosis of probable Alzheimer's disease (DSM-IV and NINCDS-ADRDA criteria)
* MRI within the last 12 months consistent with a diagnosis of AD
* MMSE score 10 to 26
* AChEI or memantine was discontinued at least 3 months prior to screening

Exclusion Criteria:

* Patient in mild cognitive impairment (MCI; CDR-SB \<2.5)
* Other central nervous disease
* hypothyroidism, Vitamin B12/ Folic acid deficiency, hypercalcemia, neurosyphilis, AIDS
* T.I.A or Major infarction within the last 12 months
* Any serious disorder that could limit the ability of the patient to participate in the study
* COPD or asthma
* Any condition which would make the patient or the caregiver, in the opinion of the investigator, unsuitable for the study
Epidemiological Study of Neonatal Acute Respiratory Distress Syndrome (ARDS)

Neonatal acute respiratory distress syndrome(ARDS) is a rare but often severe respiratory disorder. The incidence remains unclear and mortality is about 30%-60%. It is characterized by acute, refractory hypoxemia, persistent respiratory distress and decreased lung compliance. Evaluation and comparison of various clinical studies conducted were hindered by a lack of uniformity in diagnostic criteria.

In 2017, the neonatal acute respiratory distress syndrome(ARDS) Consortium Working Group has proposed diagnostic criteria for neonatal ARDS. The study consists of a prospective, multicentre, web-based,cohort study in China in which neonates who fulfil the new criteria definition are enrolled in order to: describe the epidemiology, clinical course, and prognosis of neonates affected by neonatal ARDS; identify a list of risk factors for neonatal ARDS, as it exists for adults and older children with ARDS; and guide future studies.

Eligibility Criteria:
Inclusion Criteria:

* Acute onset (ie, within one week) from a known or suspected clinical insult
* Exclusion criteria: RDS, TTN, or congenital anomalies as a primary current acute respiratory condition
* Diffuse, bilateral, and irregular opacities or infiltrates, or complete opacification of the lungs, which are not fully explained by local effusions, atelectasis, RDS, TTN, or congenital anomalies
* Absence of congenital heart disease explaining the oedema (this includes ductus arteriosus with pulmonary overflow if no acute pulmonary haemorrhage exists). Echocardiography is needed to verify the origin of oedema.
* Mild ARDS: 4≤OI\<8;Moderate ARDS: 8≤OI\<16;Severe ARDS: OI≥16

Exclusion Criteria:

* Hyaline Membrane Disease defined as:

Mandatory criteria : defined as respiratory distress syndrome appearing within the first 24 hours of life, with response to surfactant and / or volume recruitment. Additional criteria : Lung imaging Supporting the diagnosis and / or lamellar body counts \< 30,000 / mm3.

* Transient tachypnea of the neonate (wet lung) defined as:

Mandatory criteria : defined as mild ( Silverman score ≤3 ) respiratory distress appearing within the first 24 hours of life and ending within the first 48 hours of life, needing only oxygen administration and / or CPAP. Additional criteria : Lung imaging Supporting the diagnosis and / or lamellar body counts \> 30,000 / mm3.

- Patients beyond the first month of life
Study of WA-NG (NG-IMT) Telescope Prosthesis in Patients With End-stage Age-related Macular Degeneration

The purpose of this study is to evaluate the safety of the updated Model WA-NG telescope prosthesis (hereafter WA-NG telescope), an injectable telescope device, in patients with bilateral moderate to profound central vision impairment due to end-stage age-related macular degeneration.

Patients will be screened for eligibility and informed consent will be obtained from those who meet screening criteria and are interested in participating in the study. Eligible patients will be examined preoperatively to obtain a medical history and to establish a baseline for ocular condition.

Postoperatively, patients will undergo ophthalmic evaluation at regular intervals as specified in this protocol.

Eligibility Criteria:
\*\*The following Inc. \& Exc. are sample and not completed list \*\*

Main Exclusion Criteria:

* Patients with bilateral, stable, moderate to profound central vision impairment due to bilateral central scotoma associated with end-stage macular degeneration, defined as retinal findings of bilateral, geographic atrophy or disciform scar with foveal involvement.
* Patients must have distance BCVA between 20/80 and 20/800, and adequate peripheral vision in one eye (the non-implanted eye) to allow navigation
* Patients must achieve at least a five letter improvement on the ETDRS chart in the eye scheduled for surgery, with the external telescope simulator (ETS)
* Patients must be available for the study duration of 12 months
* Patients must be alert, mentally competent, and able to understand and comply with the requirements of the clinical trial, and be personally motivated to abide by the requirements and restrictions of the clinical trial.

Main Exclusion Criteria:

* Evidence of active CNV on fluorescein angiography or treatment for CNV within the past six months.
* Patients who may require fellow eye cataract extraction and intraocular lens implantation during the 12 months following WA-NG telescope implantation. If fellow eye cataract extraction is anticipated, this procedure should be performed at least 30 days prior to enrollment in the clinical study.
* Patients who have had or are expected to have ophthalmic related surgery within the 30 days preceding implantation of the device.
* Patients who have undergone previous intraocular or corneal surgery of any kind in the operative eye(s), including any type of surgery for either refractive or therapeutic purposes.
* Patients participating in any other ophthalmic drug or device clinical trial during the time of this clinical investigation
Management and Outcomes of Traumatic Eyelid Injuries in Assiut University Hospital

this study aim To determine the incidence of traumatic eyelid injuries presenting to a tertiary eye care center.

To describe the clinical characteristics of traumatic eyelid injuries, including the etiology, location, and extent of injury.

To evaluate the management approaches utilized for traumatic eyelid injuries, including surgical repair, medical therapy, and other treatments.

To assess the outcomes of traumatic eyelid injuries, including functional outcomes, cosmetic results, and complication rates

Vision is the most cared-for function of the human body, and the eyelids are provided to cover the eye for protection. Eyelids are not only protective curtains in front of the eyes but also contribute to the shape and beauty of the face. They are complex structures designed to protect the globe from various external trauma . Eyelids help to keep the corneas moist, protect against injury and excessive light, and regulate the amount of light reaching the retina. They are essential for the distribution and drainage of tears .

Traumatic eyelid injuries are a common occurrence and can range in severity from minor lacerations to more complex injuries involving the eyelid structures. These injuries can significantly impact a patient's visual function and cosmetic appearance. Understanding the epidemiology, clinical presentation, management approaches, and outcomes of traumatic eyelid injuries is important for optimizing patient care.

Eyelid injuries are an important subtype of facial trauma, which necessitates the ophthalmologist being competent and fully informed . Lacerated wounds of the eyelids are common features of ocular trauma and often occur in isolation without any associated intraocular injuries . Eyelid lacerations can be treated using different techniques depending on their depth, width, injury mechanism, and accompanying injuries. They can be repaired with primary closure, skin flap, or skin graft. Small defects limited to the skin of the eyelids can be repaired by direct closure .

Eyelid trauma may often appear trivial but can have profound effects on injury-associated morbidity. Recovery of full eyelid function and maintenance of the lacrimal apparatus are important considerations when approaching lid trauma \[. Proper information and education can help individuals to avoid eye injuries and their substantial burden .

Eligibility Criteria:
Inclusion Criteria:

* Patients of all ages presenting with traumatic eyelid injuries to the study institution in either ophthalmology or emergency departments

Exclusion Criteria:

* Patients presented with eyelid injuries who are:
* Presented late
* Presented after a previous intervention
* Known to have co-existing eyelid pathology (as tumors, infections, congenital abnormalities)
* Patients with incomplete medical records or loss to follow-up
Cardio-pulmonary Rehabilitation and Sleep Quality

In this prospective cohort study the investigators aim to evaluate the effect of pulmonary rehabilitation on sleep quality. Disturbed sleep is associated with, frequent exacerbations, increase in the severity of disease and increased mortality in chronic obstructive pulmonary disease (COPD). Sleep quality is a good predictor of quality of life in patients with stable COPD. However, there has been little investigation into non-pharmacological methods to improve sleep quality in patients with COPD and heart failure. It is also uncertain, how long the beneficial effects of cardio-pulmonary rehabilitation on sleep quality, if any, usually last. Due to lack of robust data, the investigators sought to find the effect of cardio-pulmonary rehabilitation on sleep quality.

Sleep disorders including poor quality of sleep are common in patients with heart failure, chronic obstructive pulmonary disease (COPD) and, possibly, other chronic lung disorders. These patients complain of difficulty sleeping and sleep fragmentation, often related to symptoms such as cough, sputum production or shortness of breath. Patients with COPD and heart failure commonly have other abnormalities such as nocturnal oxygen desaturation that may further worsen sleep disturbances. Moreover, sleep disordered breathing (SDB), like obstructive sleep apnea syndrome (OSA), has been linked to higher morbidity and mortality if COPD is present (known as Overlap syndrome). In patients with COPD and heart failure, cardio-pulmonary rehabilitation has important health benefits such as improvement in disease related symptoms, exercise tolerance, and health-related quality of life. However, the effect of cardio-pulmonary rehabilitation on sleep quality is controversial. Disturbed sleep is associated with frequent exacerbations, increase in the severity of disease and increased mortality in COPD and heart failure patients.

The investigators hypothesize that cardio-pulmonary rehabilitation results in improved sleep quality in patients with chronic lung disease and heart failure, this may be an important contributor to improved health outcomes after completion of cardio-pulmonary rehabilitation program.

The study will use data from questionnaires filled by the patients before and after completion of cardio-pulmonary rehabilitation. A 3-month follow up survey using the same questionnaires will be conducted to determine the longevity of improved sleep quality (if present). The questionnaires that will be used include Pittsburgh sleep quality index (PSQI), Epworth sleepiness scale (ESS), Berlin questionnaire, COPD assessment test (CAT) for COPD patients, Kansas city cardiomyopathy questionnaire (KCCQ) for heart failure patients, hospital induced anxiety and depression scale (HADS) and insomnia severity index (ISI).

Eligibility Criteria:
Inclusion Criteria:

* Age \> 18 years
* Patient who are willing to participate in follow-up survey 3 months after completion of pulmonary rehabilitation.
* Patients who complete rehabilitation for at least 8 weeks.

Exclusion Criteria:

• Not meeting inclusion criteria