cyrilzakka/clinical-trials huggingface dataset:
The Evaluation of Care Demand and Intervention Models for Individuals With ASD in Taiwan

The prevalence of autism in Taiwan has been significantly increasing over this decade. Though early intervention program and special and resource education have been applied in helping individuals with autism in Taiwan, studies regarding autism in this country so far focus mostly on the prevalence and demographics in restricted populations, diagnostic category, single case observation, and clinical research. Although the data of needs of care and intervention models in autism emerges in Western countries, there is a lack of such data in Taiwan. Due to the high prevalence, long-term impairing and lack of effective prevention, detection, and treatment for autism, tremendous of the resource is needed to be given to individuals with autism. However, the investigators do not know the gap between the need and provided care in currently. This study aims to understand the current state of needs of care and intervention in autism from different stakeholders to inform and improve the health care policies for autism and to establish a holistic care/intervention model for autism in Taiwan.

This study will enroll individuals with autism and their family members from autism-related medical, nongovernmental organizations, and general educational settings, where from elementary schools to colleges, in Taiwan. For patients and their family, the investigators will enroll total 2000 adult individuals with autism and their family members for the questionnaire survey. The needs of assessment and care, and intervention models in autism will be examined using the Chinese version of Camberwell Assessment of Need, autistic traits assessment, emotional difficulty questionnaire, quality of life and Self-administered questionnaire with different versions for stakeholders. The guides for parents and clinicians on autism will be discussed with the patient and family representatives and developed by different autism stakeholders, experts, and scholars based on regular research meetings. Quantitative analyses will be conducted to understand the need and difficulty of care and interventions in autism across different developmental stage.

The investigators anticipate to find differences in care needs by personal characteristics. The survey of the care needs of autism will provide family members, medical and nursing personnel, and related caregivers more information about understanding their care requirements. These results will help the government for the formulation of policies related to early treatment and long-term care. Finally, the guides for parents and clinician on autism would be suggested references.

Eligibility Criteria:
Inclusion Criteria:

* individuals with autism from autism-related medical, nongovernmental organizations, and general educational settings, where from elementary schools to colleges, in Taiwan.

Exclusion Criteria:

* family members of autism cannot complete questionnaire survey will be excluded from the study.
Can Calorie Labels Increase Caloric Intake

This study is a test of possible mechanisms by which calorie labels might lead people to increase calorie intake. The investigators hypothesize that calorie labels might increase calorie intake because 1) people infer that higher calorie foods are tastier, 2) calorie labels invoke thoughts of dieting, leading people to overconsume as a reaction, 3) people try to maximize calories consumed per dollar spent, and 4) calorie labels change one's goal motivation toward food, causing people to eat more.


Eligibility Criteria:
Inclusion Criteria:

* Must be able to taste items used in study

Exclusion Criteria:

* Food allergies to items used in study
Effectiveness of Medical Management of Fibrous Dysplasia of Bone.

The objective of our study was to assess the effectiveness of our reference center since its constitution.

In a retrospective cohort study, we compared the activity of our center, including the time elapsed between diagnosis and access to the center and the diagnostic delay of patients with fibrous dysplasia between two periods, 1996-2006 (before certification of our center) and 2007-2019 (after certification of our center).


Eligibility Criteria:
Inclusion Criteria:

We have included children and adults with FD/MAS who visited at least once in our center (outpatient and hospitalized patients). The diagnosis was established by an expert of the center, based on clinical, biological, imaging and/or histological arguments

Exclusion Criteria:

The absence of detectable bone lesion
SGLT2 Inhibition and Stimulation of Endogenous Glucose Production: Protocol 2

In Protocol 2, the investigators will determine the role of pancreatic hormones (increase in plasma glucagon and decrease in plasma insulin concentration) in the stimulation of EGP following SGLT2 inhibition.

The inhibition of the renal (kidney) SGLT2 transporter has proven to be an effective therapeutic intervention to reduce plasma glucose levels (amount of glucose found in the liquid part of blood) and HbA1c.

In this study, the investigators hope to define the role of increased plasma glucagon, decline in plasma insulin, and fall in plasma glucose concentration. The investigators will examine whether the signal for the increase in EGP (endogenous glucose production) caused by glucosuria (an excess of sugar in the urine, typically associated with diabetes) is mediated via the decrease in plasma glucose and insulin concentrations, or by the increase in plasma glucagon concentration.

Eligibility Criteria:
Inclusion Criteria:

* T2DM subjects
* 18 - 70 yrs old
* BMI = 25-45 kg/m2
* Must be on a stable dose (more than 3 months) of monotherapy or combination therapy with metformin and/or a sulfonylurea
* HbA1c \<10.0%
* Stable body weight (± 3 lbs) over preceding 3 months
* Do not participate in excessively heavy exercise

Exclusion Criteria:

* Subjects taking drugs known to affect glucose metabolism (other than metformin and sulfonylurea)
* Individuals with evidence of proliferative diabetic retinopathy, plasma creatinine \>1.4 females or \>1.5 males, or 24-hour urine albumin excretion \> 300 mg
DEPRECAP: Lung Cancer Screening Programme by LDCT for Patients With COPD or Emphysema.

The DEPRECAP (Early detection of lung cancer) study is an ongoing, prospective, longitudinal, multicenter lung cancer screening program that recruited individuals with COPD or emphysema from the pulmonary clinics of Fundación Jiménez Díaz University Hospital and Villalba General Hospital, in Madrid, Spain.

The aim of this observational study is to determine the scientific evidence needed to study the benefit and potential effects of lung cancer screening in this group of patients and to determine the long-term effects of the intervention in reducing the high mortality rates associated with late-stage lung cancer diagnosis in a very high-risk population, to address under-diagnosis of COPD and to promote smoking cessation. This leads to the creation of a registry with clinical, radiological, functional data and biological samples for future studies in this cohort of patients to provide the scientific evidence needed to study the benefit and potential effects of screening for lung cancer and other tobacco-related pathologies diagnosed by Low-dose CT (LDCT)

Participants who met the inclusion/exclusion criteria detailed below and agreed to participate, underwent annual LDCT and pulmonary function tests until age 75 or 15 years of smoking abstinence, whichever came first. The study protocol was approved by the Ethics Committee of the Fundación Jiménez Díaz (ER2_EO180-19_FJD-HGV) and all participants signed their informed consent.

Inclusion criteria were males or females, 55-75 years of age, current or former smokers (Less than 15 years of abstinence) with a cumulative smoking exposure of greather than 30 pack-years and a diagnosis of COPD according to the GOLD guidelines and/or emphysema identified by LDCT. Individuals with a recent history of cancer (except non-melanoma skin cancer or carcinoma in situ) as well as those with other medical conditions that posed a significant risk of death were excluded.

Eligibility Criteria:
Inclusion Criteria:

* Current or former smokers (\>15 years of abstinence) with a cumulative smoking exposure of \> 30 pack-years
* Diagnosis of COPD according to the GOLD guidelines and/or emphysema identified by LDCT and/or a carbon monoxide diffusing capacity (DLCO) lower than 80% of predicted (as per the Global Lung Function Initiative (GLI) equations)

Exclusion Criteria:

* Individuals with a recent history of cancer (except non-melanoma skin cancer or carcinoma in situ) as well as those with other medical conditions that posed a significant risk of death were excluded from the study.
Clinical Characteristics, Treatment and Prognosis of Chest Tightness Variant Asthma

Asthma, abbreviation for bronchial asthma, is one of the common chronic airways disease that threatens human health. Typical symptoms of asthma are recurrent wheezing, shortness of breath, chest tightness and cough, usually occurring at night or early morning. However, there are still some patients with only persistent clinical manifestations of chest tightness. Concerned about this group of patients, we presented a subgroup of bronchial asthma, namely, chest tightness variant asthma (CTVA). This asthma subgroup usually lacks asthma-specific clinical features such as wheezing, shortness of breath, wheezing, and therefore often misdiagnosed for a long time. In order to further understand the clinical characteristics, pathogenesis, and prognosis of patients with CTVA, we conducted a national multicenter observation study to further understand CTVA. Finally, we plan to clarify whether CTVA is a relatively independent asthma phenotype. Meanwhile, reducing misdiagnosis and perform an appropriate treatment of CTVA.


Eligibility Criteria:
Inclusion Criteria:

1. all subjects agreed to participate, understand the project, observe the use of drugs, agree to follow-up, and signed informed consent;
2. the age of more than 14 and less 80 years old, gender and ethnicity are not limited;
3. the duration time was more than 6 months,and chest tightness was the only complaint, without breathing, short of breath, chronic cough;
4. no wheezing;
5. a diagnosis of asthma supported by one or more other characteristics:

   * bronchial provocation test positive;
   * improvement in forced expiratory volume at one second (FEV1) of more than 12% and 200 mL after inhaled salbutamol;
   * variability in diurnal peak expiratory flow (PEF) of more than 10% for one day during one week.
6. bronchodilator and glucocorticoid treatment is effective;
7. exclude the following diseases by the corresponding doctors: coronary heart disease, myocarditis, heart failure, GERD, neuromuscular disease, and mental disease.

Exclusion Criteria:

1. can not cooperate with related inspection or for other reasons;
2. patients with chronic obstructive pulmonary disease, interstitial pneumonia, active tuberculosis, community acquired pneumonia, lung cancer, bronchiectasis, cor pulmonale, pulmonary embolism, and accompanied with serious systematic disease (such as coronary heart disease, myocarditis, heart failure, gastroesophageal reflux disease, neuromuscular disease, etc);
3. history of drug abuse, alcohol abuse or anesthesia or with a history of mental illness (schizophrenia, obsessive-compulsive disorder, depression) and against personality, motivation, suspicious, or other emotional or mental issues that may affect participation in the study;
4. taking part in other drug clinical trial project, or drop out less than 3 months;
5. during pregnancy, lactation women;
6. obvious abnormal of High Resolution CT.
Pain and Neck Dysfunction Following Dry Needling With and Without Intramuscular Electrical Stimulus.

Participants will be 18-59 years old who are recruited through a convenience sample from the UMHB/Belton community. There will be a randomized control trial consisting of three groups. Each participant will be assigned based on their order of entry to the study group assignment and then randomly organized via computer generation into 3 groups of 20 participants including a control group, a dry needling group (DN), and a dry needling E-stim group (DN-ES), resulting in approximately 60 total participants. Participants in the DN and DN-ES groups will be treated four times; at weeks 0, 2, 4 and 6 of the study. Data will be collected at weeks 4, 6 and 12 in all groups.

Interventions per group:

Control: none

DN: 20-30 seconds of DN per trigger point in each involved trapezius muscle, needles rest in situ 10 min, needles removed.

DN-ES: 20-30 seconds of DN per trigger point (TrP) in each involved trapezius muscle, DC ES attached to needles crossing the most reactive TrP and current set to strong, but comfortable intensity at 10 MHz for 10 min, needles removed.

Eligibility Criteria:
Inclusion Criteria:

1. 18-59 years old
2. have an active email account
3. have at least one palpable active trigger point (TrP) (located in one or both upper trapezius)
4. English speaking

Exclusion Criteria:

1. current treatment or diagnosis related to cancer
2. active local or systemic infection
3. neurologic deficit
4. cognitive deficit
5. pregnancy
6. connective tissue disease and/or autoimmune disorder
7. tobacco use
8. received previous DN treatments within 6 weeks of the study,
9. experienced unilateral or bilateral neck/shoulder pain continuously for 3 months or longer
10. Neck Disability Index score \< 6
11. Numerical Pain Rating Scale score \< 3
Time Restricted Feeding on Impaired Glucose Regulation(TRIG Trial)

We evaluated the effects of Time-Restricted Feeding (TRF) regimen on Impaired Glucose Regulation (IGR) in comparison with overweight/obese patients receiving standard of care over 12 months.


Eligibility Criteria:
Inclusion Criteria:

1. Aged ≥ 18 year
2. Diagnosis of impaired glucose regulation (i.e. FG between 5.7-6.9mmol/L) +/- impaired glucose tolerance (i.e. 2-hour postprandial PG between 7.8-11.1mmol/L) confirmed by latest OGTT results within 3 months prior to recruitment
3. Body mass index (BMI)of 23.0 to 45.0 kg/m2;

Exclusion Criteria:

1. Confirmed diagnosis of DM or on hypoglycaemic treatment
2. Women who are pregnant or breast-feeding at recruitment
3. Patients taking glucocorticoid at recruitment
4. Active and uncontrolled thyroid diseases (including subjects on thyroid replacement therapy or anti-thyroid drugs) or active endocrine diseases such as Cushing's syndrome or Acromegaly at recruitment
5. Serious liver dysfunction or chronic kidney disease (AST or ALT \> 3 times the upper limit of normal, or eGFR\<30 ml/min/1.73 m2);
6. History of serious cardiovascular or cerebrovascular disease (angina, myocardial infarction or stroke) in the past 6 months;
7. Taking medications affecting weight or energy intake/energy expenditure in the last 6 months, including weight loss medications, antipsychotic drugs or other medications as determined by the study physician;
8. Currently participating in weight loss programs or weight change in the past 3 months (\> 5% current body weight) ;
9. Patients who cannot be followed for 24 months (due to a health situation or migration);
10. Patients who are unwilling or unable to give informed consent.
A Study to Evaluate the Efficacy and Safety of Tanfanercept (HL036) in Dry Eye Disease

The objectives of this study are to compare the efficacy and safety of tanfanercept ophthalmic solution 0.25% and 1.0% to vehicle for the treatment of DED.

The purpose of this research study is to test the safety and effectiveness (how well the drug works) of Tanfanercept ophthalmic solution 0.25% and Tanfanercept ophthalmic solution 1% against vehicle (no active treatment). Effectiveness will be measured by the improvement in Schirmer Test results (a test to see how many tears you produce), reduction of dry eye symptoms, eye redness (conjunctival redness), and eye surface irritation (corneal staining, conjunctival staining). Eye safety assessments will also be performed.

Eligibility Criteria:
Inclusion Criteria:

1. Are at least 18 years of age
2. Provide written informed consent
3. Are willing to attend all study visits and able to comply with study procedures and assessments
4. Have a self-reported history of DED (OU) for at least 6 months prior to Visit 1

Exclusion Criteria:

1. Have an uncontrolled systemic disease
2. Have been exposed to an investigational drug or device within 30 days or 5 half-lives prior to Visit 1, whichever is longer
Nutritional Status Of Under-Six Children: Epidemiology Study (NUTRI-STAT)

This study permit to evaluate the characteristics of children in third year of preschool, during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual medical visit.The aim of the study is to describe the nutritional status of children under-six years of age: underweight, overweight, and obesity considering the sex. .

For several decades the eating behavior has been changing. That note is obviously more true for children, with the arrival of new recipes, not really healthier for all. This study permit to evaluate the characteristics of children in third year of preschool, during a year, in 16 schools in Thionville (north-eastern France) by the way of the annual medical visit. The aim of the research is to estimate the healthy weight corresponding with a height considering the gender.

Eligibility Criteria:
Inclusion Criteria:

* third year of preschool in Thionville
* information of the legal responsibles

Exclusion Criteria:

* opposition of the legal responsible for gathering data
Mental Stress Symptoms in Family Caregivers of Palliative Patients

Receiving a life-limiting diagnosis is often a shock for those affected as well as for their relatives, which changes the entire life situation of the family. New perspectives often arise, as well as feelings of worry, sadness and powerlessness. Caregiving is often an extreme physical challenge, but above all a psychological one.

Aims of the study

1. To investigate whether family caregivers of palliative patients with severe trait anxiety in the care situation also suffer from severe state anxiety.
2. To investigate whether family caregivers of palliative patients with increased stress levels and burnout-promoting work-related behaviour suffer more from burnout symptoms, health-related anxiety and psychosomatic complaints.
3. To investigate the impact of nursing support by a mobile palliative team on family caregivers of palliative patients.


Eligibility Criteria:
Inclusion criteria:

* Women and men between 18 and 90 years of age
* Current palliative care situation of a relative with a life-limiting diagnosis.

Exclusion criteria:

* Persons incapable of giving consent (e.g. dementia, delirium, etc.)
* Failure to meet the inclusion criteria
sTErnAl heMostasiS Trial

Sternal bleeding remains an unsolved problem for cardiac surgery teams costing operative time, blood loss, and distraction from the critical operative field. As such, the following is an investigator-initiated trial to determine whether application of a topical hemostatic agent reduces sternal bleeding during cardiac surgery using sternotomy approach.

This is a prospective randomized 1:1 trial to evaluate the efficacy of the application of HEMOBLASTTM during cardiothoracic surgery to reduce the increased risk of sternal bleeding in 30 treatment and 30 control patients.

Enrollment will be open to all eligible participants undergoing cardiothoracic surgery who sign an informed consent.

The study will also collect demographic data and relevant clinical data, such as medical history, diagnosis, family history, laboratory data, radiological images and reports, and diagnostic procedure reports.

All enrolled subjects will be followed during their hospitalization until discharge for bleeding complications after their surgical procedure as well as a sternal bleeding SPOT GRADE TM score will be recorded independently by both the cardiac surgeon and assisting cardiothoracic PA-C, before and after the application of the topical hemostatic agent. There will be no restriction on the use of electrocautery or vancomycin paste as existing routine adjuncts used in cardiothoracic surgery for sternal hemostasis. Chest tube output measurements will be collected at 6, 12, and 24 hours postoperatively. The patients will be assessed at the time of hospital discharge for any complications related to sternal or intrathoracic bleeding.

Eligibility Criteria:
Inclusion Criteria:

* Patients are scheduled to undergo on-pump open chest cardiothoracic surgery.
* Patients must be willing and able to provide written informed consent.
* If the patient is of childbearing potential, they must have a negative pregnancy test within 24 hours of the index procedure.
* Patients must be at least 21 years of age.
* Patients have at least one of the following risk factors:

  1. Undergoing redo sternotomy
  2. Have a preoperative platelet count \<150 mg/dL
  3. Are on dual antiplatelet therapy (blood thinners) \< 5 days prior to sternotomy
  4. Have a BMI (body mass index)\> 35
  5. Are undergoing combined CABG (coronary artery bypass surgery)/valve surgery
  6. Have chronic kidney disease (GFR \<60 ml/min) or ESRD (end stage renal disease)

Exclusion Criteria:

* Patients who undergo thoracotomy approach
* Patients who are not deemed an appropriate candidate by the investigator.
* Patients who are pregnant or nursing, or who plan to become pregnant during the course of this study.
A Trial of Centanafadine Efficacy and Safety in Adolescents With Attention- Deficit/Hyperactivity Disorder

This trial was conducted to evaluate the efficacy and safety of the Centanafadine once daily (QD) extended release (XR) capsules in adolescent participants (13 - 17 years, inclusive) with attention-deficit/hyperactivity disorder (ADHD).

The trial consisted of a screening period of up to 28 days (4 weeks), a 42-day (6-week) double-blind treatment period, and a 7 (+ 2)-day follow-up period.

Eligibility Criteria:
Inclusion Criteria:

* Males and females aged 13 to 17 years (inclusive) at the time of informed consent/assent.
* A primary diagnosis of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, 5th edition (DSM-5) diagnosis criteria as confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
* A minimum symptoms total raw score of ≥ 28 on the Attention-Deficit/Hyperactivity Disorder Rating Scale Version 5 (ADHD-RS-5) at baseline for all participants.
* A score of 4 or higher on the Clinical Global Impression - Severity - Attention Deficit/Hyperactivity Disorder (CGI-S-ADHD) at baseline.

Exclusion Criteria:

* A comorbid diagnosis of: Tourette's Disorder, Generalized Anxiety Disorder severe enough to interfere with trial procedures, Panic Disorder, Conduct Disorder, Psychosis, Post-traumatic Stress Disorder, Bipolar Disorder, Autism Spectrum Disorder, Binge Eating Disorder, Anorexia, Bulimia, Oppositional Defiant Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), Obsessive-Compulsive Disorder severe enough to interfere with trial conduct (allowed if it is not the primary focus of treatment), or major depressive disorder (MDD) with current major depressive episode.
* Participants who are breast-feeding and/or have a positive pregnancy test result prior to receiving investigational medicinal product (IMP).
* A significant risk of committing suicide based on history and the investigator's clinical judgment, or routine psychiatric status examination, Current suicidal behavior, Imminent risk of injury to self, Active suicidal ideation. History of suicidal behavior (over the last 6 months).
* Body mass index (BMI) ≥ 40 kg/m2 or ≤ 5th percentile for age and gender based on United States (US) Centers for Disease Control and Prevention (CDC) criteria.
* Has initiated, changed, or discontinued receiving psychological interventions for ADHD within the 30 days before the screening visit, or is anticipated to start new treatment during the trial.