cyrilzakka/clinical-trials huggingface dataset:
Focus-out Glasses on Emmetropization in Chinese Children

The purpose of this study is to characterize the effects of peripheral focous-out glasses on emmetropization in non-myopic Chinese Children Aged 6-8 Years.This is a prospective, parallel-controlled randomized trial.

Myopia is one of the most common eye diseases that cause visual impairment and blindness, and the high rate of myopia in young people is a major public health issue. Based on the clinical studies of optical defocusing to regulate eye growth and refractive changes through visual signal feedback, we hypothesize that early wearing of peripheral defocus glasses in children can slow down the process of emmetropization and even prevent the onset of myopia by producing more myopic defocusing. The aim of this study is to investigate whether wearing peripheral defocus glasses can effectively delay emmetropization in non-myopic children aged 6-8 years , and to further explore its effect on preventing the onset of myopia.

The study adopts a 2-year，single-centre, randomized, parallel-controlled trial with a non-blinded design. Subjects who pass the screening period will have their baseline data collected and will be assigned to the experimental or control groups according to the randomization principle. The experimental group will be fitted with Direct Emmetropia with Focus-out Glasses (hereafter referred to as DEFOG) to guide the emmetropization process. The control group will be given no treatment and will be a blank control. Baseline data including visual acuity, cycloplegic objective refraction, axis length, accommodation amplitude, strabismus examination, pupil size, choroidal thickness and peripheral retinal refraction will be measured when enrolled in the group and follow-up data will be measured at month 6, 12, 18 and 24. The primary interest of this study will be studied by comparing the difference in cycloplegic objective refraction changes between month 24 and baseline in the two groups of subjects.

Eligibility Criteria:
Inclusion Criteria:

1. Age: ≥6 and ≤8 years at enrollment.
2. At least one parent' s Spherical equivalent refraction≤-3.00D.
3. Spherical equivalent refractions (SERs) under cycloplegia: +0.50 to +1.50 diopters (D)
4. Astigmatism ≤1.00 D .
5. Anisometropia ≤1.00 D.
6. Best Corrected Visual Acuity (BCVA) : 1.0 or better
7. Provision of consent written by subject's legal guardian
8. Willing and able to participate in all required activities of the study

Exclusion Criteria:

1. Any of the following abnormalities on the ocular surface, such as trachoma, pemphigoid, chemical injury, heat burn, radiation injury, etc.
2. Eyelid abnormalities (e.g. entropion, ectropion, tumor, edema, blepharospasm, incomplete eyelid closure, severe trichiasis, severe ptosis) ,which affect eyelid function in either eye
3. Eye diseases such as strabismus, amblyopia, anisometropia, fundus diseases, and accommodation abnormality，etc.
4. Prior treatment of myopia control in either eye, including but not limited to drugs, orthokeratology, low-level red-light therapy, etc.
5. Noncompliance with measurement at enrollment.
Systematic Oral Education for Prevention of Oral-related Complications Caused by Radiotherapy for Head and Neck Cancer

A study on the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors

The goal of this clinical trial is to investigate the efficacy of systematic oral health education for oral-related complications in patients with head and neck malignant tumors who receive radiotherapy. The main question it aims to answer is:

the efficacy of systematic oral health education for the prevention oral-related complications caused by radiotherapy for head and neck malignant tumors

Participants will:

be given systematic oral health education or routine oral health education be evaluated to learn the efficacy of systematic oral health education for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors Researchers will compare systematic oral health education group with routine oral health education group to see if systematic oral health education has good efficacy for the prevention of oral-related complications caused by radiotherapy for head and neck malignant tumors.

Eligibility Criteria:
Inclusion Criteria:

* Patients diagnosed with malignant tumors of the head and neck without metastasis
* Age ≥18, ≤80 years old
* ZPS score ≤2
* Receiving radiotherapy alone or concurrent radiotherapy with a radiation dose of \>50 Gy
* Signed informed consent form

Exclusion Criteria:

* Patients with oral mucositis due to allergic reactions to certain foods, medications, or oral care products
* Have a history of head and neck radiotherapy
* Poor oral hygiene or severe periodontitis
* Poor compliance
* Other patients who, in the opinion of the investigator, are not suitable for participation in this study
Neuromuscular Electrical Therapy in Venous Ulcers

The use of neuromuscular electrical stimulation in the treatment of venous ulcers with difficulty of repair could be an alternative therapeutic favoring devitalized tissues and hence the pain.

The aim of this study is to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency.

The aim was to evaluate the effect of neuromuscular electrical stimulation on pain and area of venous ulcers in patients with venous insufficiency. In a simple-blind controlled clinical study, 20 subjects with venous ulcers with age over 50 years will be divided in two groups:neuromuscular electrical stimulation(n=10) and control group (n=10). Pain (by Visual Analogue Scale) and the ulcer area (by planimetry on graph paper and the software ImageJ ®) were measured.

Eligibility Criteria:
Inclusion Criteria:

* Subjects of both genders
* aged over 50 years
* sedentary and with clinical diagnosis of chronic venous insufficiency with ulcer in lower limbs will be included

Exclusion Criteria:

* Subjects with pacemakers
* diabetes
* uncontrolled hypertension
* osteomyelitis and pain of unknown origin
* unable to walk or make use of drugs that acted directly on the healing process will be excluded
Rate and Predictors of Relapse in the Treatment of Hepatitis C (Study P05181)

This is an observational, multicenter, nationwide study where information will be collected on the follow-up of participants with chronic hepatitis C virus (HCV) who have a viral response at the end of treatment with pegylated interferon alfa-2b (PEG IFN alfa-2b) plus ribavirin (RBV) administered according to the directions on the products' labeling. No administration of treatment is planned as a result of study enrollment.


Eligibility Criteria:
Inclusion Criteria:

* Participants with chronic hepatitis C virus (HCV)\[any genotype\] who received pegylated interferon alfa-2b plus ribavirin as first treatment for hepatitis C.
* Negative HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate), measured by the assay used at each institution. Only institutions using an assay with a limit of detection of 50 IU/mL or less will be eligible.

Exclusion Criteria:

* Women of childbearing potential (i.e., premenopausal women and women who are less than 6 months postmenopausal) who will not use an appropriate contraceptive method during the course of the clinical study. Appropriate contraceptives include double barrier methods (eg, diaphragm or condom plus spermicide), intrauterine device, oral, injectable or subcutaneous hormonal contraceptive, or surgically sterilized partner.
* Completed treatment with pegylated interferon alfa-2b plus ribavirin more than 4 weeks before study entry.
* Positive HCV RNA at the end of treatment (24 or 48 weeks according to the product labeling as appropriate).
* Participants treated for a period shorter than the enrollment period.
* Co-infection with Human Immumodeficiency Virus (HIV).
* Co-infected with Hepatitis B Virus (HBV).
Samsung Medical Center-Lymphoma Cohort Study-II

The purpose of this study is to establish a model which can predict the treatment outcome and the risk of treatment-related morbidity in patients with lymphoma.

Although the cure rate of lymphoma has been increased due to the development of newer effective drugs, a substantial portion of patients is still suffered from relapse. Furthermore, the treatment-related morbidity is another factor which can make the treatment outcome worse in patients with lymphoma, especially elderly patients. Thus, this study is going to assess factors which may affect the treatment outcome and the risk of treatment-related morbidity.

1.Biologic factors associated with the aggressiveness of lymphoma

* molecular markers in serum, cytogenetic markers 2.Factors associated with the risk of treatment-related morbidity
* comorbidity, nutrition status, performance status, quality of life at diagnosis

Eligibility Criteria:
Inclusion Criteria:

* Patients who were diagnosed as lymphoma
* Over 19 years old
* Patients who agreed the enrollment of study
* Informed consent for sampling

Exclusion Criteria:

•Patients who do not want to join the study
Human Phototoxicity Test (823/2016)

To determine the phototoxic potential of a topically applied article in human subjects


Eligibility Criteria:
Inclusion Criteria:

* be male or female between the ages of 18 and 60 inclusive;
* be lightly pigmented (Fitzpatrick Skin Type I, II, III);
* have read and signed the written Informed Consent Form and have completed a HIPAA Authorization Form in conformance with 45CFR Parts 160 and 164;
* be in general good health as determined by the subject's medical history and in the discretion of the investigator;

Exclusion Criteria:

* have a visible sunburn;
* have a history of sun hypersensitivity/photosensitivity or photosensitive dermatosis;
* must not have a known sensitivity or allergy against any of the active and non-active ingredients of the test product.
* have a history of allergies or sensitivities to cosmetics, toiletries or any dermatological products
Demographic Outcomes, and Health Care Resources in Newly Diagnosed Non Valvular AF Patients

1. To describe the patterns of care of newly diagnosed patients with NVAF vs VAF in the first-line, second-line and beyond second line setting, including, treatment plan, regimen, dosing, duration of treatment, and reason for interruption and termination along with treatment switching at any point of treatment, regardless if the patients are considered of first line, second line or further within the treatments.
2. To describe the clinical outcomes (stroke/systemic embolism, bleeding complications, as well as cause-specific and all-cause mortality) with NVAF vs VAF.
3. To describe the values and distribution of International normalized ratio (INR) in patients who received VKAs and to assess the influence of Time in therapeutic range (TTR) and INR history on clinical outcomes (stroke/systemic embolism, bleeding complications) with NVAF vs VAF.
4. To evaluate AF-related healthcare resource utilization and direct costs associated with the management of AF patients with NVAF vs VAF.

and To describe the baseline clinical and demographic characteristics as well as risk factors among patients newly diagnosed with NVAF versus VAF.


Eligibility Criteria:
Inclusion Criteria:

* 1. All male or female patients aged 18 years and older at the date of inclusion.

  2. Patient newly diagnosed \[within the recruitment period (estimated to be 6 months) and 90 days before the baseline visit\] with atrial fibrillation (AF) and for whom treatment has started by the caring physician for the prevention of stroke/systemic embolism.

  3. Signed informed consent.

Exclusion Criteria:

* 2. Severe psychiatric illness or other disease or circumstances that could compromise participation in the study. Patients will not be enrolled if major difficulties with follow-up will be anticipated, for example, patients with no valid residency permit or those planning to leave the country before the next scheduled follow-up.

  3. Current participation in an interventional clinical trial at baseline. 4. AF with a generally reversible cause defined as non-cardiac surgery, post-cardiac surgery (AF within 3 months after surgery), hyperthyroidism, pulmonary embolism, pneumonia and acute myocardial infarction.

  5. Mechanical heart valves or valve disease expected to require valve replacement.

  6. A medical condition other than AF for which chronic use of VKA/NOAC is indicated.

  7. Pregnant or breast-feeding women. Pregnancy to be ruled out according normal practice method of each site.
Comparison of Dexmedetomidine and Midazolam for Prevention of Emergence Delirium in Children

Emergence delirium is a common complication in children after anesthesia. The incidence of emergence delirium is reported upto 50%. Prevention of emergence delirium in children is important not only for the patient safety but also for the satisfaction of the parents. Midazolam is the most commonly used medications for prevention of emergence delirium. However, it might lead to delayed awakening from anesthesia and respiratory depression. In this study, the investigators will evaluate whether dexmedetomidine can be effectively and safely administered for prevention of emergence delirium in children compared to midazolam.

In this study, seventy patients scheduled for elective tonsillectomy aged from 24 months to 12 years old Anesthesiologists physical status (ASA) class 1 and 2 will be enrolled. The sample size was calculated based on the former study with a type 1 error estimate of 0.05 at 80% power. The proportion in dexmedetomidine group (group D) was assumed to be 0.4 and the proportion in midazolam group (group M) was 0.1. Considering the drop-out rate of 10%, seventy patients in total were needed.The patients will randomly be allocated into the group D or the group M. The group D will receive dexmedetomidine0.3mcg/kg mixed with 0.9% normal saline, 10mL in total. The group M will receive 0.03mg/kg of midazolam mixed with 0.9% normal saline, 10mL in total. Randomization and drug administration will be done by a single anesthesiologist. Assessment of the patient will be done by another anesthesiologist blinded by the group. Five minutes before the end of the surgery, the study drug will be slowly infused for 5 minutes. In the postanesthesia circuit unit (PACU), presence of emergence delirium will be assessed. The emergence delirium will be assessed by the four-point agitation scale. (1 = calm, 2 = not calm but gould be easily calmed, 3 = not easily calmed, moderately agitated or restless, and 4 = combative, exited or disoriented.) Patients with score 3 and 4 will be diagnosed as emergence delirium and treated with intravenous fentanyl 1mcg/kg. Severity of emergence delirium will be assessed with the pediatric anesthesia emergence delirium scale after 10 mins on arrival of PACU. Pain wil be scored by 5-point scale (0 = no pain, 5 = severe pain ever). Time from discontinuation of anesthetic gas to extubate will be recorded. The data will be compared between the groups by the independent t-test or Mann-Whitney test for the continuous variables. Chi-square test or Fisher's exact test will be used for the categorial variables.

Eligibility Criteria:
Inclusion Criteria:

* Patients undergoing elective tonsillectomy under general anesthesia
* American society of anesthesiologist physical status 1,2
* aged from 24 months to 12 years old
* obtaining written informed consent

Exclusion Criteria:

* known history of allergy to dexmedetomidine or midazolam
* renal impairment
* hepatic impairment
* long QT syndrome
* developmental disorder
* congenital disorder
* neurologic disorder
* psychogenic disorder
Clinical Prediction Thyroid Cancer With Thyroid Ultrasonography

Iodine ingestion insufficiency was widespread existence in the 50's in Taiwan, induced the hypothyroidism with the popular name "the big neck". After many experts study and evaluation, goiter was gradually disappeared after salt adding iodine in the 60's. But the nodule of the thyroid gland was widespread on the Taiwan island. This situation was a particular victim in living in the mountainous area inhabitant. The middle area populaces suffer from the thyroid gland disease really popular than other areas. Recently literature reported that the cancer rate of thyroid gland rises gradually. In according to the statistics, thyroid cancer prevalence probably has 10% in the nodular goiter.

The major early preliminary diagnosis of the thyroid cancer is thyroid fine-needle aspiration cytology (FNAC), but this technique must to have skilled clinical puncture's doctor and to have special training cytological pathology doctor. Therefore, if we can have simple fast screening tool and can make up this insufficiency, then we can achieved the fast diagnosis, rapid processing, the promotion diagnosis and treatment quality and promotes the survival percentage. The thyroid ultrasonography (Thyroid US) is one universal, fast, cheap, and the simple diagnosis nodular goiter tool. If we can friendly use this tool, we can early diagnosis \& management this disease.

This research collect subjects from Jan 2002 to Dec 2016 under procedure of thyroid US, FNAC and thyroidectomy. Preliminary design index of thyroid gland tumor score (TTS) was to survey and analysis.


Eligibility Criteria:
Inclusion Criteria:

* 1. Patients with nodular goiter had thyroidectomy from 2002 January to 2016 December in CMUH.
* 2. Patients had thyroid sonography within one year before thyroidectomy.
* 3. All data at least was interpreted by 3 endocrinologists under the blind method.

Exclusion Criteria:

* 1. Patients with nodular goiter hadn't thyroidectomy.
* 2. Patients hadn't thyroid sonography.
* 3. All data was interpreted by endocrinologists under the blind method, but interpretation results were inconsistent.
Effects of Aerobic and Strength Exercice on Nociplastic Pain in Temporomandibular Disorders

Chronic temporomandibular disorders are common in the general population. Nociplastic pain seems to be present in this pathology, with an hypersensitivity to touch, pressure and movement observed in both local and remote areas, as weel as comorbidities such as fatigue, sleep disturbance, difficulty to focus attention and memory disturbance. The best evidence-based treatment of temporomandibular disorders consists in combining education, manual therapy and therapeutic exercise in both temporomandibular and cervical regions. Aerobic and strength exercises showed to be effective in subjects with chronic pain and nociplastic pain, by inducing an hypoalgesic effect. However, there isn\&#39;t investigation about the effects of theses types of exercise in subjects with temporomandibular disorders and nociplastic pain. Thus, the aim of the study is to determine if adding aerobic or strength exercise to an effective physical therapy programme is more effective than physical therapy alone to improve nociplastic pain in subjects with temporomandibular disorders.

Introduction: Temporomandibular disorders used to improve with education manual therapy and therapeutic exercise. However, despite the evidence oh nociplastic pain in these patients, the treatments remain local. As aerobic and strength exercice have hypoalgesic effect in chronic musculoskeletal pain, we aim to study the effects combined with a common physical therapy programme on nociplastic pain in patients with temporomandibular disorders.

Main objective: Determine if aerobic exercice and strength exercice combined with physical therapy are more effective than physical therapy alone to improve local and remote pressure pain threshold (temporals, masseters, sternocledomastoids, upper trapezius, handgrip, quadriceps and gastrocnemius), in subjects with temporomandibular disorders and nociplastic pain.

Material and methodos:

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of a myogenic temporomandibular disorder (DC/TMD) by an odontologist.
* Chronic pain (\&gt;3months)
* Nociplastic pain
* Positive Flexion Rotation Test
* Be physically able to realize aerobic and strength exercise (functional movement test)

Exclusion Criteria:

* History of trauma, TMJ or cervical fracture the past three months
* History of TMJ or cervical surgery
* Systemic, rheumatic, metabolic, neurologic, psychiatric, pulmonary diseases or neoplastic malignant
* History of cardiovascular diseases which contraindicate aerobic exercise
* Current orthodontic treatment, splints for bruxism
* Drug addiction, alcoholism
* Pregnancy
* Use of analgesic medication less than 48 hours before each data collection
* Physical therapy treatment during the past three month
Palliative Care Planner (PCplanner)

The purpose of this research study is to determine the feasibility, acceptability, and evidence for clinical impact of a mobile app-based program called Palliative Care Planner (PCplanner) in addressing needs and promoting advance care planning discussions among patients with idiopathic pulmonary fibrosis and their clinicians.

Interstitial lung disease (ILD) affects roughly 6.3 to 76 per 100,000 people of predominantly older adult patients worldwide and is associated with high morbidity and mortality. Patients with such idiopathic pulmonary fibrosis suffer symptom burdens similar to patients with cancer and commonly experience long, costly hospitalizations that often include care in an intensive care unit (ICU). Despite the presence of numerous unmet needs, ILD patients uncommonly receive palliative care because of lack of symptom recognition, supports to provide advanced care planning (ACP) and symptom control, and processes to promote collaboration between primary teams and palliative care specialists to deliver the appropriate level of care. To address this important clinical gap, we propose adapting our existing needs-targeted PCplanner (Palliative Care planner) mobile app platform to the outpatient setting. PCplanner Outpatient will allow patients to report their needs, provide video content to stimulate knowledge of and discussion about more advanced care planning, and assist primary physicians in recognizing the optimal timing of specialist palliative care referral.

Eligibility Criteria:
Inclusion Criteria:

* Patient has diagnosis of idiopathic pulmonary fibrosis
* Patient has GAP (gender, age, physiology) index score ≥ 4
* Patient is established in interstitial lung disease clinic (i.e., has had at least 1 previous clinic visit)

Exclusion Criteria:

* Patient lacks fluency in English sufficient to complete study surveys
* Patient is already seeing palliative care or enrolled in hospice
* NEST score \<10 at baseline T1
A Study to Assess the Effects of Single Ascending Doses of ASP1707 in Healthy Young Japanese Male Subjects

Three groups of 8 Japanese males are given single ascending doses of ASP1707 or placebo to assess the safety and tolerability, and to evaluate how it is absorbed, metabolized and distributed through the body.

The first group receives the lowest dose while the last group receives the highest dose. ASP1707 or matching placebo is administered as a single dose under fasted conditions.

Screening takes place from Day -22 to Day -2. Subjects are admitted to the clinic on Day -1 and remain until Day 5. An end of study visit (ESV) takes place 7-14 days after discharge.

Escalation to the next higher dose takes place after review of the safety and tolerability data from the previous dose.

Safety assessments are performed throughout the study. Plasma and urine samples are collected for pharmacokinetics (PK) analysis. Serum samples are collected for pharmacodynamic (PD) analysis.

Eligibility Criteria:
Inclusion Criteria:

* Born in Japan
* Both parents are of Japanese descent
* Time residing outside Japan does not exceed 5 years
* Maintains Japanese life style including diet
* Male subject must be non-fertile, i.e. surgically sterilized or must practice an effective contraceptive method

Exclusion Criteria:

* Subjects with out-of-range T levels in serum at screening
* Subjects with any history of cancer