cyrilzakka/clinical-trials huggingface dataset:
Paraorbital-Occipital Alternating Current Stimulation Therapy of Patients With Post-Chiasmatic Lesions

Visual field areas, which are not absolutely blind, are hypothesized to have some residual capacities that constitute their potential for vision restoration. Vision restoration can be achieved by varies methods including behavioral training and electrical brain stimulation such as transcranial direct current stimulation (tDCS) and repetitive transorbital alternating current stimulation (rtACS) which are able to influence the excitability and activity of cortical areas.

It is hypothesized that transorbital alternating current stimulation (tACS) can improve the residual field of vision in patients with post-chiasmatic lesions.


Eligibility Criteria:
Inclusion Criteria:

* lesion of the tractus opticus or of the visual cortex
* lesion age \> 6 months
* stable visual field defect with residual vision

Exclusion Criteria:

* electric or electronic implants, e.g. heart pacer
* any metal artefacts in the head
* Epilepsy
* Auto-immune diseases in acute stage
* mental diseases, e.g. schizophrenia etc.
* diabetic retinopathy
* addictive diseases
* blood pressure above 160/100 mmHg
* instable or high level of intraocular pressure above 27 mmHg
* retinitis pigmentosa
* pathological nystagmus
* presence of an un-operated tumor or tumor relapse (patients with non-progressive tumor are eligible if study participation is recommended by medical authorities)
* focal findings in EEG or photosensitivity (patients with single seizure more than 10 yrs ago may participate)
* recurrent transitional ischemic attacks after stroke
* arteriosclerosis of large blood vessels with stenosis \>75%
* severe coronary heart disease (CHD)
* unstable angina pectoris
* diabetes with blood glucose level \> 9 mmol/l
* myocard infarct/ cardiomyopathy
* ventricular fibrillation
* risk of vascular thrombosis
* pregnant or breast-feeding women
The Cardiac Effects of Empagliflozin in Patients With High Risk of Heart Failure

The aim of this trial is to assess the effect of Empagliflozin on cardiac mass, volumes, cardiac biomarkers, metabolism, daily activity level, health-related quality of life in patients in elderly and obese patients with increased risk of developing heart failure. The primary hypotheses are that 180 days of treatment with Empagliflozin 10 mg a day will: 1) reduce left ventricular mass index, and 2) increase peak VO2 (maximal oxygen consumption) compared with placebo.

The Empire Prevent: Cardiac is a part of the Empire Prevent Trial Program, which also comprises the Empire Prevent: Metabolic

Eligibility Criteria:
Inclusion Criteria:

* Body mass index \>28kg/m2
* Age 60-84 years
* Established risk factor for developing heart failure, defined as at least one of the following:
* hypertension
* ischemic heart disease
* stroke/transient cerebral ischemia
* chronic kidney disease (eGFR 30-45ml/min/1.73m2)

Exclusion Criteria:

* Diabetes mellitus type 1 or 2 (no medical history, no antidiabetic treatment)
* Heart failure with reduced ejection fraction (LVEF \<40%)
* Inability to perform exercise test
* Dementia
* Severe non-compliance
* Substance abuse
* Severe chronic obstructive pulmonary disease (FEV1\<50% expected value)
* Permanent atrial fibrillation
* GFR \<30 ml/min/1,73m2
* Severe peripheral artery disease
* Cancer treatment within one year beside prostate cancer and basal cell carcinoma
* Severe aortic or mitral valve disease
* Pregnancy or breastfeeding
* Acute hospital admission within 30 days
* Participation in other pharmacological study
Safety of Transarterial Chemoembolization (TACE) in the Setting of an Elevated Bilirubin

The aim of this study is to evaluate the safety of selective transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) in the setting of an elevated total bilirubin, but relatively normal direct bilirubin.


Eligibility Criteria:
Inclusion Criteria:

* hepatocellular carcinoma (HCC)
* Direct or conjugated bilirubin \< 3 mg/dl
* Total bilirubin \> 3 mg/dl
* Willing and able to provide informed consent
* \>18 years of age

Exclusion Criteria:

* Currently pregnant
* Patients who are surgical or ablation candidates as determined by multidisciplinary hepatobiliary tumor conference.
* Arterial anatomy which would preclude selective transarterial chemoembolization
* Patients who have a INR or platelet count which are not correctable to \<1.8 and \>35,000 respectively
* Patients with extrahepatic metastases
* Patients with portal vein invasion
Feeding and Sucking in Preterm Infants

This study aimed to determine the effect of oral motor stimulation (OMS) in preterm infants for successful feeding and sucking.

In recent years, with advances in methods of neonatal resuscitation and caring methods, the survival rate of preterm infants has gradually increased. Sucking, swallow and respiratory dysfunction are widespread complications in the preterm infants that reason oral feeding difficulties. Safe and successful oral feeding requires proper maturation of sucking, swallowing, and respiration. The development of behaviors necessary for safe and successful nutrition begins long before birth. Jaw movements begin to be seen in the intrauterine 11th week. But sucking-swallowing-respiratory coordination is not sufficiently developed before 34 weeks of gestation. For this reason, preterm babies at the greater gestational week usually show more developed and consistent feeding skills. Maternal breast milk is best for neurodevelopment in preterm infants. Achieve oral feeding and maternal breast milk as early as possible is beneficial for preterm infants.

Oral motor stimulation (OMS) is defined as the sensorial stimulation of cheek, lip, jaw, upper-lower gum, internal cheek, tongue and soft palate that affects the physiology of oropharyngeal mechanisms and develops feeding functions. OMS used as an alternative or supplementary early intervention strategy to develop oral feeding skills in preterm infants. Previous studies have indicated that the use of OMS during or before the transition to oral feeding may not only have positive effects on the preterm infants' feeding behaviors but also enhance their general clinical course. Preterm infants who suffer from oral feeding problems often experience longterm health problems and delayed discharge from the hospital. A more effective feeding decreases adverse outcomes by decreasing hospital stays.

Preterm infants are required to prolonged NICU stay in order to stabilized, feeding, and gain optimal weight. Increasing prematurity and reduced birth weight lead to extensive resource utilization. In addition all nutritional options except breast milk increase the cost. OMS can develop sucking success and provide early oral feeding. Thus nurse labor and hospital costs may decrease and OMS can be a cost-effective application.

,

Eligibility Criteria:
Inclusion Criteria:

* Born between 29th and 34th gestational weeks, based on the mother's last menstruation date,
* Percentile measurements consistent with their gestational week measurements,
* Stable vital signs,
* APGAR scores between 4 and 10 in the 1st and 5th minutes,
* Stable for 48 hours after having received mechanical ventilation and/or continuous positive airway pressure,
* Being breastfed,
* Mother's eagerness to breastfeed the infant,
* Voluntary participation of parents in the study.

Exclusion Criteria:

* Suffered from severe asphyxia,
* Born with a low birth weight according to gestational week,
* Have intraventricular bleeding,
* With a congenital anomaly,
* Babies without their mother.
Phase II Study for Robot Assisted Distal Gastrectomy

The aim of this study is to clarify safety of robot assisted distal gastrectomy with lymph node dissection in patients with stage Ia early gastric cancer.


Eligibility Criteria:
Inclusion Criteria:

1. Biopsy specimen from the primary lesion shows adenocarcinoma
2. Diagnosed as Stage IA early gastric cancer according to the preoperative esophagogastroduodenoscopy and computer tomography
3. Endoscopic submucosal dissection is not indicated
4. Tumor was located within lower two thirds of stomach
5. Not having duodenal invasion
6. Eastern clinical oncology group performance status is 0 or 1
7. Body mass index is lower than 30
8. No prior laparotomy
9. No prior chemotherapy or radiation including those for other cancers
10. Fulfil all following conditions WBC \> 3,000/mm3 Plt \> 100,000/mm3 AST \< 100 IU/L ALT \< 100IU/L T.Bil \< 2.0 g/dl Cre \< 1.5mg/dl

Exclusion Criteria:

1. Having other active cancers
2. Possibly pregnant, or breast feeding woman
3. with psychiatric disorder
4. Receiving steroids
5. With Acute myocardial infarction in 6 months or with unstable angina
6. With uncontrolled hypertension
7. With uncontrolled diabetes mellitus
8. With pulmonary disease which require continuous oxygen therapy
Icotinib for Completed Resected IB NSCLC With EGFR Mutation

This phase II trial studies how well icotinib works in treating patients with completely resected stage IB NSCLC harboring EGFR mutation.

Adjuvant chemotherapy have shown little evidence of survival benefit in patients with stages IB non-small cell lung cancer (NSCLC) after complete resection. Epidermal growth factor receptor tyrosine kinase inhibitors (EGFR-TKIs) show great efficacy in patients with EGFR mutant non-small cell lung cancer (NSCLC). Icotinib is a novel EGFR-TKI developed by a group of Chinese scientists and clinician. In the phase III ICOGEN trial, icotinib had non-inferiority efficacy to gefitinib with better safety. This study is studying icotinib to see how well it works in treating patients with fully resected stage IB NSCLC harboring EGFR mutation.

Eligibility Criteria:
Inclusion Criteria:

* Written informed consent provided.
* Males or females, Aged 18-75 years.
* Able to comply with the required protocol and follow-up procedures, and able to receive oral medications.
* Had completely resected pathological confirmed stage IIA-IIIA NSCLC.
* EGFR activating mutation in exon 19 or 21.
* Patient who can start the investigational therapy within 3-6 weeks after the complete resection.
* ECOG performance status of 0-1.
* Had a life expectancy of 12 weeks or more.
* Adequate hematological function, adequate liver function and renal function.
* Female patients, except those who are postmenopausal or surgically sterilized, must have a negative pre-study serum or urine pregnancy test.

Exclusion Criteria:

* Had had previous chemotherapy, radiotherapy, or agents directed at the HER axis (e.g. erlotinib, gefitinib, cetuximab, trastuzumab).
* Inability to comply with protocol or study procedures.
* Had a history another malignancy in the last 5 years with the exception of cured basal cell carcinoma of the skin, cured in situ carcinoma of the uterine cervix and cured epithelial carcinoma of the bladder.
* Any evidence confirmed tumor recurrence before investigational therapy.
* Known severe hypersensitivity to icotinib or any of the excipients of this product.
* Evidence of clinically active interstitial lung disease.
* Eye inflammation not fully controlled or conditions predisposing the subject to this.
* Any unstable systemic disease (including active infection, uncontrolled hypertension, unstable angina, congestive heart failure, myocardial infarction within the previous 6 months, serious cardiac arrhythmia requiring medication, hepatic, renal, or metabolic disease).
* Known human immunodeficiency virus (HIV) infection.
* Pregnancy or breast-feeding women.
* Ingredients mixed with small cell lung cancer patients.
* History of neurologic or psychiatric disorders.
Behavioral Changes Among Asthmatic Children in Sohag Universty Hospital

Asthma is considered the most common chronic childhood disease and mainly affects children resident in urban areas. Asthma has been designated a serious public health problem due to the increase in its prevalence over the last two decades and the associated high health service costs in admissions and hospitalizations The cause of asthma is not yet completely understood, and there is no consensus about its etiology. A vast body of research emphasizes the role of genetic and environmental factors in the appearance of asthma, and a great deal of interest has recently emerged concerning the relationship between psychosocial factors and asthma morbidity Behavioural problems in children are generally described as "internalizing", which includes "anxiety, depressive, and somatic symptoms" or "externalizing", which includes "oppositional, hyperactive conduct". Both internalizing and externalizing problems can be experienced by healthy children with abnormal and "borderline" personality disorder, the latter referring to a mental illness marked by an ongoing pattern of varying moods, self-image, and behaviour


Eligibility Criteria:
Inclusion Criteria:

Children aged 4-12 years Confirmed diagnosed as asthma

Exclusion Criteria:

Children below age of 4 years and aboveage of 12 years . Diagnosed with any other chronic medical conditions (e.g., cardiac , liver , renal and other chronic chest diseases) .

Patient with cerebral palsy.
Early Extracorporeal Shockwave Therapy for Erectile Dysfunction in Radically Prostatectomised Men.

The purpose of this project is to assess the relationship between low intensity shock wave treatment (LI-SWT) and erectile function (ED) in patients who have undergone radical prostatectomy (RP).


Eligibility Criteria:
Inclusion Criteria:

* Radically prostatectomised men
* Non nerve-sparing or nerve-sparing RP.
* Age 20-80 years
* Have been in a relationship for more than 3 months.
* Sexually active
* Patient can give informed consent.

Exclusion Criteria:

* Men with ED of neuropathological or psychogenic origin
* Rectal extirpation, radiation therapy to the pelvic area and recovery from any other cancer within the past 5 years are excluded.
* Patients with heart disease prohibiting sexual activity or taking medication with antiandrogens, anticoagulant (apart from aspirin) or systemic use of glucocorticoids within 5 weeks.
A Phase I Clinical Study on SHR6390 in Healthy Chinese Volunteers

This study was to evaluate the pharmacokinetics and safety of SHR6390 at doses of 100 mg, 125 mg, and 150 mg after process modification in Chinese healthy volunteers. A single oral dose of SHR6390 was given to each group, including 100 mg, 125mg and 150mg of SHR6390.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Chinese male and female aged 18-45years with a minimum weight of 50 kg for male and 45 kg for female subjects and a body mass index (BMI) of 18-26 kg/m2 who provided written informed consent for participating in the study.
* Without history of cardiovascular, hepatic, kidney, pulmonary, endocrine, gastrointestinal, neurological, or psychiatric disease.
* No pregnancy plan during the trial or within 6 months after completion of the trial.
* Voluntarily signed the informed consent form and strictly adherence to the study protocol.

Exclusion Criteria:

* vital signs, physical examination, 12-lead electrocardiogram, and laboratory examination had results of clinical significance.
* Hepatitis B and C, human immunodeficiency virus (HIV) and syphilis antibody positive;
* Any history of allergy, alcohol and drug abuse;
* blood donation, massive blood loss (≥400mL).
* Participated in other clinical trials within three months. (6) Severe infection or surgery four weeks prior to screening;
* use of any drug that inhibits or induces hepatic metabolizing enzymes four weeks prior to screening;
* use of any prescription drugs, over-the-counter drugs, Chinese herbal medicines and health care products fourteen days prior to screening;
* A history of dysphagia, gastrointestinal ulcers, or any gastrointestinal disease that interferes with drug absorption.
"Family-centered" Pediatric Rehabilitation Services in Children With Developmental Disabilities

Developmental disability is a severe chronic disabled condition caused by mental or physical impairments. Children with developmental disabilities may face life-long difficulties in motor functioning, self-care, condition, communication, and independent living. They often receive rehabilitation services to promote daily functions and participation in home, school, and community lives.

"Family-centered" service has been considered as "best practice" in pediatric rehabilitation. Therapists encourage children with developmental disabilities and their parents to participate in decision making and implementing process of intervention, and provide intervention plan that best fit their family needs. Research shows that for children with developmental disabilities, family-centered services can enhance children's development, decrease parenting stress, promote emotional wellness, and increase parental satisfaction to services. Though the "family-centered" concept has been considered as relevant in pediatric rehabilitation, there are still difficulties, as well as a lack of evidence regarding its implementation in practice.

Reflecting the trend of family-centered medical care, the benefits of national health insurance in Taiwan for early intervention outpatient care will emphasize on family-centered intervention. The range of benefits may include communication with parents, parental education, consultation and instructions for home programs. Besides, outcomes of family-centered intervention will be treated as an important index for monitoring the quality of medical services.

Given that there is a lack of investigation regarding the family-centered pediatric rehabilitation, the purposes of this one-year research project are to investigate the implementation of family-centered pediatric rehabilitation for children with developmental disabilities and to identify related influencing factors. This study will provide empirical evidence for family-centered services in Taiwan.


Eligibility Criteria:
Inclusion Criteria:

1. children aged 2 to 12 years.
2. children with a primary diagnose or condition associated with developmental disabilities, including attention deficit hyperactivity disorder, autism, intellectual disability, Down syndrome, learning disorders, cerebral palsy, and other developmental delay.
3. parents agree to participate in this study.

Exclusion Criteria:

1. children with unstable physical conditions, such as cancer, having surgery within 3 months, infection, or other active medical conditions.
2. children with progressive disease (e.g. neuromuscular disease) or degenerative disorders (e.g. degenerative seizures).
SIBTime Phase II: Web Application for Typically Developing Siblings

Most of the over 32.7 million people in the U.S. who have special health, developmental, and mental health concerns have typically developing (TD) brothers and sisters who share high levels of involvement in their sibling's lives. Disability and health agencies lack effective tools to support the information and support needs of TD siblings and their families, in particular for ethnic minority and rural families. The aims of this proposal are to complete development and evaluation of the dual language SIBTime app, designed to build parents' and children's knowledge, skills, and engaging family routines to nurture TD siblings' (ages 3-6) social-emotional health and well-being.

An 8-week RCT will be conducted to evaluate the full-scale SIBTime program in a sufficiently powered randomized controlled trial evaluation (sample size = 160 parent/child dyads). SIBTime will be assessed in terms of its relevance, acceptability, cultural appropriateness, and efficacy. Participants will complete measures pre- and post- intervention selected to detect changes in parenting stress and adjustment, parent-child relationship, parents' self-efficacy and frequency of engagement in the targeted parenting strategies, and TD sibling behavior and adjustment. Information will also be collected on family demographics, consumer satisfaction, usability ratings, usage metrics, and recommendations for modifications to the program.

Eligibility Criteria:
Criteria:

Inclusion criteria:

1. Parent of a child with a disability and a typically developing child aged 3-6
2. Has a smartphone or tablet
3. Speaks English or Spanish

Exclusion criteria:

1. None
Reducing Disparities in Medication Adherence in SLE

This is a pilot study to assess the feasibility of using Surescripts refill data during the clinical encounter to improve medication adherence in patients with systemic lupus erythematosus


Eligibility Criteria:
Inclusion Criteria

- All followup patients seen at the Duke Lupus clinic

Exclusion Criteria

* Patients not seen at the Duke Lupus Clinic
* New patients seen for the first time at the Duke Lupus Clinic
* Patients who are not prescribed any lupus medications
RESOLUTE Japan - The Clinical Evaluation of the MDT-4107 Drug-Eluting Coronary Stent

The objective of the study is to verify the safety and efficacy of the MDT-4107 Drug-Eluting Coronary Stent for the treatment of de novo lesions in native coronary arteries.


Eligibility Criteria:
Inclusion Criteria:

* Acceptable candidate for percutaneous coronary intervention (PCI),stenting, and emergency coronary artery bypass graft surgery
* Clinical evidence of ischemic heart disease, stable or unstable angina, silent ischemia and/or positive functional study
* Informed consent
* Patient agrees to comply with specified follow-up evaluations at same investigational site
* Single target lesion or two target lesions located in separate coronary arteries
* De novo lesion(s) in native coronary artery(ies)
* Target lesion(s) ≤ 27 mm in length
* Target vessel(s) have reference vessel diameter 2.5 mm to 3.5 mm

Exclusion Criteria:

* Within 7 days of implant platelet count \<100,000 cells/mm³ or \>700,000 cells/mm³; white blood cell (WBC) count \<3,000 cells/mm³; serum creatinine level \>2.5 mg/dl
* Acute myocadial infarction (MI) within 72 hrs of the index procedure (Q wave myocardial infarction(QWMI) or any elevation of Creatinine Kinase Mycocardial-band Isoemzyme (CK-MB) \> lab upper limit of normal)
* Previous PCI of target vessel(s) within 9 months prior to the procedure
* Planned PCI of any vessel within 30 days post-index procedure and/or planned PCI of target vessel(s) within 12 months post-index procedure
* History of stroke or transient ischemic attack (TIA) within prior 6 months
* Participating in investigational drug/device study that has not completed primary endpoint or interferes with study endpoints
* Inability to comply with required trial antiplatelet regimen
* Previous stent in target vessel unless it has been at least 9 months since stent placed and target lesion(s) is/are at least 15 mm from previous stent
* Target vessel(s) has/have other lesions w/ \> 40% diameter stenosis
* Unprotected left main coronary artery disease
PRKAA2 Genetic Polymorphisms and Its Susceptibility to Chinese Type 2 Diabetes Mellitus and Diabetic Nephropathy

Metformin is a classical oral antidiabetic drug, often recommended to be the first-choice treatment of type 2 diabetes mellitus (T2DM). Based on the previous research on PRKAA2, STK11 and diabetes, this study aimed to investigate the distributive characteristic of PRKAA2 and STK11 polymorphisms and the potential influence of STK11polymorphisms on metformin efficacy among Chinese T2DM patients, discuss the association of PRKAA2 polymorphisms between T2DM patients and healthy subjects.


Eligibility Criteria:
Inclusion Criteria:

* diagnosed with T2DM in keeping with the WHO criteria in 1999 \[14\], with fasting blood glucose (FBG) ≥ 7.0mmol ⁄ L and ⁄ or postprandial blood glucose (PBG) ≥ 11.1mmol ⁄ L; not using other antidiabetic drugs within the experimental period.

Exclusion Criteria:

* other significant illness such as cancer, myocardial infarction, stroke, severe liver, and kidney disease