cyrilzakka/clinical-trials huggingface dataset:
Impact of Electronic Devices on Myopia Development and Progression

The aim of the stuy is to investigate the effects of the adoption of a curriculum with electronic devices for teaching materials and textbooks in Hong Kong schoolchildren on their changes in refractive error and visual function.

With the blooming of information technology and electronic engineering in recent years, e-books or tablet computers have been introduced at some local primary and secondary schools and have been provided for their students during studying at school and at home. Parents and teachers' utmost concern are adverse effects on eye-sight of children, especially the higher progression rate in myopia and the visual discomfort which may be caused by the e-book technology.

This is a prospective cohort study to determine if implementation of electronic devices for teaching promotes myopia development and progression and affects visual function in primary schoolchildren.

The schools will introduce e-books to their students in some classes. Signed informed consent letters from parents will be obtained prior to subject recruitment and data collection. Eye examination and data collection will be conducted in primary school campus. The children from two local primary schools in same grade will be assigned into two groups by their schools. One group will use e-books (e-book group) to study course materials assigned by their teachers whereas another group will use ordinary textbooks (control group). Their refractive errors, axial length (AXL) and binocular functions will be measured and monitored at six-month intervals for a maximum of 2 years.

Eligibility Criteria:
Inclusion Criteria:

* Chinese
* study local primary schools

Exclusion Criteria:

* with any ocular diseases and binocular anomalies might affect visual functions or refractive development
* with history of eye surgery
* have undertaken any kind of myopia control treatment, such as bifocal lenses, orth-K, eyedrops (e.g. atropine)
Effects of Structured Simplified Short-term Intensive Insulin Therapy on Long-term Glycemic Remission

Short-term intensive insulin therapy is shown to induced glycemic remission, but traditionally patients were hospitalized for 2-4 weeks in order to receive the therapy, the long inpatient period precluded the wide application of the thrapy. This study aims to invesitgate whether simplified regimen is non-inferior to traditional regimen in achieving long-term glycemic remisson.


Eligibility Criteria:
Inclusion Criteria:

* newly diagnosed type 2 diabetes with no prior hypoglycemic agents application, or on hyperglycemic monotherapy for less than 1 week;
* GHbA1c ≥ 9%
* Body mass index between 20-35kg/m2
* Capable to use wearable devices and mobile Apps;
* willling to follow the study protocol and data collection.

Exclusion Criteria:

* Type 1 diabetes or specific types of diabetes;
* Allergic or intolercance to medicine used in the study;
* Acute diabetic complications (diabetic ketoacidosis, hyperosmotic hyperglycemia coma or lactic acidosis);
* Severe diabetic microvascular complications (proliferative retinopathy, clinical proteinuria,uncontrolled diabetic neuropathy and obvious diabetic autonomic neuropathy;
* Glomerular filtration rate less than 50 ml/min
* ALT \>2.5 times of the upper limit of normal (ULN), or bilirubin \> 1.5 times of ULN；
* Significant Macrovascular disease:acute cerebrovascular accident, acute coronary syndrome or peripheral artery disease that required vascular intervention or amputation 12 months before enrollment;
* Poor blood pressure control (systolic blood pressure≥180mmHg and/or sitting diastolic blood pressure ≥110mmHg) and unable to control under 160/110mmhg within 1 week;
* Hemoglubin level \< 100g/L or required regular blood transfusion;
* Chronic cardiac dysfunction with NYHA grade III or above;
* Use of medicines that affect blood glucose for a cumulative time of more than 1 week within the prior 12 weeks, such as oral/venous glucocorticoid, growth hormone, estrogen/ progesterone, high-dose diuretics, antipsychotic drugs. However, low-dose diuretics for antihypertensive purposes (HCTZ \< 25mg/d, indapamide \< 1.5mg/d) and physiologic replacement of thyroid hormone are allowed;
* Serious systemic disease or malignant tumor, chronic diarrhea, etc；
* Uncontrolled abnormalty in endocrine glands (Cushing's syndrome, hyperthyroidism, etc.);
* Any factors that may affect the participation of the subject in the study or the evaluation of the results；
* Pregnancy or planned pregnancy, lactation subjects.
Effect of Calcium/Vitamin D Supplementation on Body Weight and Fat Loss.

The aim of this study was to assess the effect of calcium/vitamin D supplementation (Caltrate 600 +D®) on body weight loss during a weight-reducing program

The effect of a calcium supplementation on body weight loss is inconclusive and some studies have suggested that adequate calcium intake can have a favourable effect on some metabolic variables. The objectives of this study were to evaluate the impact of (Caltrate 600 + D ®) on body composition and various indicators of metabolic health in overweight and obese females characterised by a usual low daily calcium intake, on a weight-reducing program.

The main hypotheses of this study were:

* Caltrate 600 +D® increases body weight and fat mass losses of individuals on a weight-reducing program.
* Caltrate 600 +D® improves the metabolic profile of these subjects, independently of variations promoted by body fat loss.

Eligibility Criteria:
Inclusion Criteria:

* Daily calcium intake below 800mg/day
* Stable body weight
* Body mass index (BMI) between 27-40kg/m2
* Less than 3 periods of 20 minutes of physical exercise/week
* General good health
* Normal blood pressure values
* Normal cholesterol levels
* Normal thyroid hormone levels
* No participation in another clinical trial within 6 months of screening
* Coffee consumption ≤ 5 cups/day.

Exclusion Criteria:

* Breast feeding, pregnant or menopaused women
* Use of calcium supplements within 30 days of screening
* Cholesterol levels requiring pharmaceutical treatment
* Smoking
* Use of medication that could affect body weight
Dose Finding Trial to Assess the Efficacy and Safety of SOTB07 in Persistent Asthma

This study is a dose finding trial to assess the efficacy and safety of SOTB07 in persistent asthma.

A 12 week, Multi-center, Randomized, Double blinded, Parallel group, Placebo-controlled, 4-arm, Dose finding trial to Assess the Efficacy and Safety of SOTB07 in persistent asthma.

Eligibility Criteria:
Inclusion Criteria:

1. Male or eligible female subjects aged 15 years or more
2. A female is eligible if she is of:

   * Non-child bearing potential (i.e., physiologically incapable of becoming pregnant), including any female who is at least 2 year after post- menopausal
   * Child bearing potential and agrees to the acceptable contraceptive methods used consistently and correctly
   * Negative pregnancy test at screening
3. Non-smoker for at least 1 year, a pack history of ≤ 10 pack years
4. Symptom of persistent asthma, as defined by the National Institute of Health (NIH)
5. 50% ≤ FEV1 ≤ 85% predicted at screening visit (withholding inhaled, short acting ß-agonist for 6 hours)
6. FEV1 reversibility ≥ 12% and 200 ml at 20-30 minutes after inhalation of a short acting ß-agonist (Salbutamol 2 puffs; 200㎍) at Visit 1 or within 6 months before Visit 1
7. Capable of withholding salbutamol use for ≥ 6 hours prior to clinic visits
8. Appropriately signed and dated informed consent has been obtained

Exclusion Criteria:

1. Active upper or lower respiratory tract infection within 3 weeks before visit 1
2. Emergency room treatment for asthma within 1 month or hospitalization for asthma within 3 months before visit 1
3. Any evidence of infectious, oncologic, or other active pulmonary disease obtained by chest radiography within 12 months before visit 1
4. Clinically significant, in the opinion of the investigator, hematological, liver, renal, heart, neurological disease, or other serious disease
5. Hypersensitivity to any β2-agonist, sympathomimetic drug, leukotriene receptor antagonist or Sophora tonkinensis Radix Rhizoma
6. Clinically significant and uncontrolled psychiatric disease or history of drug or alcohol abuse
7. Inhaled, oral or parenteral corticosteroids within 4 weeks before visit 1
8. Change of Immunotherapy within 6 months before visit 1
9. Administration of the antiasthma agent within 1 week of visit 1
10. Administration of any other medication which may affect the course of asthma, or interact with sympathomimetic amines
11. Participation in study using an experimental medication within 1 month before visit 1
12. Other ineligible subject in the opinion of the investigator
Health Promotion and Cardiovascular Risk Reduction Among People With Spinal Cord Injury

This study is a controlled pragmatic implementation study in clinical practice, with a primary focus on cardiovascular risk reduction through adherence to behavioral interventions related to physical activity and healthy diet.The intervention is interdisciplinary, multimodal and patient activating and uses the existing setting and work flows at the clinic, ensuring that the patients receive education about cardiovascular risk factors, physical activity and healthy diet through a systematic approach including targeted patient education.

This clinical intervention study will investigate the effectiveness of a uniform and systematic institutional strategy incorporating targeted strategic patient education about cardiovascular risk factors, physical activity and a healthy diet lifestyle starting early in the primary rehabilitation process with 6 months of follow up compared to a historic control group. Test - retest reliability of four different VO2 peak tests and a multi sensor accelerometer respectively will be assessed as well.

Eligibility Criteria:
Inclusion Criteria:

* All newly injured patients (within the last 12 months) with Spinal Cord Injury admitted at Clinic for Spinal Cord Injuries, Rigshospitalet.

Exclusion Criteria:

* Insufficient skills in Danish language
* Reduced mental function that prevents reading and answering the questionnaires
Trial of a Culturally-Appropriate Weight Loss Intervention for Overweight Latino Children

This project aims to conduct a unique, community-based intervention consisting of a randomized trial of a culturally-appropriate weight loss intervention for overweight Latino children in Milwaukee. The intervention promotes lifestyle changes through a low weight loss regimen, one or more physical activities ranging from soccer to hip-hop dance, and dietary counseling including cooking classes for parents. In addition to weight reduction for overweight Latino children, the project has the potential to reduce missed school days and improve self-esteem and quality of life.


Eligibility Criteria:
Inclusion Criteria:

* Children must be of Latino descent
* At risk for becoming overweight or is overweight
* 6-17 years old.

Exclusion Criteria:

* Age \> 17 years old
* Not overweight or at risk for becoming overweight
* Non-Latino ethnicity/race.
R3470-3471-3479 (REGN-EB3) Expanded Access Protocol (EAP) for Treatment of Ebola Virus Disease

Provide access to REGN-EB3 for the treatment of patients with Ebola Virus Disease (EVD).


Eligibility Criteria:
Key Inclusion Criteria:

* Males or females in an Ebola endemic region with documented positive polymerase chain reaction (PCR) for Ebola virus infection who are symptomatic
* Ability to provide informed consent personally or by a legal representative if the patient is unable to do so, based on local laws and regulations
* REGN-EB3 can be administered to pregnant women infected with Zaire ebolavirus, as defined in the protocol
* Children of any age will be eligible for enrollment, as defined in the protocol
* Neonates born to an infected mother who has not yet cleared the Ebola virus are eligible for enrollment, as defined in the protocol

Key Exclusion Criteria:

* Negative EBOV diagnostic test result
* A patient who, in the judgment of the investigator, will be unlikely to comply with the requirements of this protocol
* Any serious medical condition that, in the opinion of the site investigator, would place the patient at an unreasonable increased risk through participation in this study, including any past or concurrent conditions
* Eligible for an ongoing randomized clinical trial with REGN-EB3

NOTE: Other protocol defined inclusion / exclusion criteria apply
Transcriptome Analysis of Human Bone Regeneration After Using an Anorganic Bovine Bone Graft With or Without a Combination of Polynucleotides and Hyaluronic Acid

The goal of this clinical trial is to compare the expression of multiple genes related to bone regeneration in maxillary bone after being grafted with a commonly used biomaterial supplemented or not with a combination of hyaluronic acid and polynucleotides.


Eligibility Criteria:
Inclusion Criteria:

* Partially edentulous patients.
* Kennedy class I in the upper jaw.
* Less than 5 mm of residual crestal bone to the maxillary sinus.
* Need for the replacement of teeth with dental implants.

Exclusion Criteria:

* Sinus pathology (sinusitis, mucocele, cysts).
* Smokers.
* Previous long-term (\&gt;3 months) use of drugs known to affect bone metabolism, such as bisphosphonates.
Study the Effect of Upper Expansion Appliances on Lower Jaw Forward Projection/Growth

Young children with backward positioned lower jaw/chin will be recruited to have an upper jaw expansion appliance. Previous research showed that the use of similar appliances can lead to lower jaw forward growth. 60 young children aged 9-11 will be recruited to have either active or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the treatment. After participation, routine orthodontic treatment will be continued.

Previous research showed that the use of upper jaw expansion appliances can lead to lower jaw forward growth (1). 60 young children aged 9-11 with backward positioned lower jaw/chin will be recruited to have either active or non-active Wilson type upper arch expansion appliance. Patients will have special x-ray (Cone Beam computed tomography) before and after treatment (after 9 months) of starting the treatment. After participation, routine orthodontic treatment will be continued.

Eligibility Criteria:
Inclusion Criteria:

1. Class II skeletal due to lower jaw backward projection
2. Class II malocclusion
3. Early mixed dentition (all first permanent molars erupted, as well as all erupting upper and lower permanent incisors)

Exclusion Criteria:

1. Other orthodontic treatment provided
2. Growth problems (craniofacial syndromes, etc.)
Effects of Auricular Vagus Nerve Stimulation on the Pro-inflammatory Cytokine Response in Healthy Adults

The autonomic (self-regulating) nervous system is important for the function of many organs in the body. The vagus nerve is part of the autonomic nervous system. The vagus nerve carries incoming information from the nervous system to the brain, providing information about what the body is doing, and it also transmits outgoing information which governs a range of reflex responses. It plays an important role in the immune system. A part of the vagus nerve is reachable for stimulation at specific locations in the ear.

The purpose of this study is to better understand how different ways of stimulating the vagus nerve at the ear can affect a chemical marker of inflammation found in human blood that is associated with a variety of inflammatory diseases such as rheumatoid arthritis and lupus. This information may lead to in future studies to see if stimulation of the vagus nerve can improve inflammation in chronic inflammatory diseases.


Eligibility Criteria:
Inclusion Criteria:

* Between 18 and 60 years old
* Currently healthy with no medical problems
* Non-smoker

Exclusion Criteria:

* History of any of the following: cardiac arrhythmia, coronary artery disease, chronic inflammatory disease, anemia, malignancy, depression, connective tissue disease (arthritis, vasculitis), neurologic disease, diabetes mellitus, renal disease, malignancy, dementia, psychiatric illness including active psychosis, or any other chronic medical condition
* Use of cholinergic, anti-cholinergic, or beta-blocking medications
* Family history of inflammatory disease
* Pregnancy
* Smoking
* Ear infection (otitis media or externa)
* Implanted vagus nerve stimulator
Muscular Activations During Eccentric Quadriceps Exercises

The aim of this study is to investigate muscular activations during various quadriceps exercises commonly used in clinical settings.

The quadriceps muscle is known to be crucial for the dynamic control of the lower extremity, and weakness in this muscle can lead to strategies that may result in injury. Therefore, acquiring optimal quadriceps muscle strength is essential not only for preventing lower extremity injuries but also for enabling individuals to fully return to activities after an injury.

Despite the existence of various eccentric quadriceps exercises in the literature, there is a lack of consensus on their comparative effectiveness. Hence, there is a requirement for research to explore the effectiveness of different eccentric quadriceps exercises. The objective of this study is to compare the muscular activation of the quadriceps muscle during four distinct eccentric quadriceps exercises using surface electromyography (sEMG) devices

Eligibility Criteria:
Inclusion Criteria:

Being a licensed athlete in one's own field, Having been engaged in sports for at least 2 years

Exclusion Criteria:

Individuals with any musculoskeletal injury history in the lower extremities and trunk that could impede exercise within the last year, Individuals with systemic, neurological, and/or cognitive issues, Individuals experiencing pain in the lower extremities and trunk during exercises
A Brief Mindful Drinking/Eating Intervention for Hemodialysis Patients With Fluid Restrictions

The purpose of this pilot study is to find out whether mindful drinking/eating activities can improve quality of life and help make it easier for people on dialysis to follow their fluid restrictions. The pilot study is a randomized controlled trial with an intervention group and a wait list control group, randomized by cohort days. The intervention occurs during dialysis sessions once a week for 4 weeks. During each intervention session, participants are guided through a mindful eating exercise focused on foods recommended for controlling thirst (e.g., hard candy, frozen grapes) and a mindful drinking exercise. Participants are asked to practice mindful drinking/eating at least once daily at home.


Eligibility Criteria:
Inclusion Criteria:

* Receiving hemodialysis
* Able to speak English

Exclusion Criteria:

* Missed more than one dialysis treatment in the past month
Effects of OsteoStrong vs. Individually Adapted and Combined Training on Bone Health

The aim of this clinical trial is to investigate the effect of the OsteoStrong training method and the Individually Adapted and Combined Training on the bone health of older women with high fracture risk. Additionally, the aim is also to explore the participants' experiences of each training method.

Participants will be randomised to either treatment arm A (OsteoStrong) or treatment arm B (Individually Adapted and Combined Training). Participants in both groups will train for nine months. Treatment arm A will train individually once a week and treatment arm B will train in a group twice a week. Both groups will have a training instructor who will supervise and give training instructions.

Researchers will compare the groups to see the effects of the training methods on the participants' bone health among other outcome measures. The participants will be tested at baseline and post-intervention (9 months later).


Eligibility Criteria:
Inclusion Criteria:

* Woman, 65-79 years old.
* Vaccinated against Covid-19.
* Be able to participate in nine months of training.
* Untreated with Osteoporosis-medications, or have an ongoing treatment since at least one year back.

Exclusion Criteria:

* Ongoing treatment with Osteoporosis-medications with an onset within a year, or a previous treatment which was terminated within the last five years.
* Ongoing treatment with Osteoporosis-medications that has been delayed for more than eight months for Denosumab, or more than 18 months for bisphosphonates.
* Vertebral fracture, that have been diagnosed within three months.
* Vertebral fracture or hip fracture, that have not previously been treated with Osteoporosis-medications or been assessed by a physician.
* Bilateral hip replacements.
* Symptomatic disc herniation, inguinal herniation or umbilical herniation.
* Untreated hypertension.
* Other diseases that can affect the results and participation in the study: malignant diseases, muscle dystrophy, secondary osteoporosis, or other conditions that would hinder study participation.
* Ongoing treatment with oral cortisone pills (≥ 5 mg Prednisolone).
* Conditions that hinders the conduction of impact microindentation with OsteoProbe: large edema, skin infection, allergy towards local anaesthetics.
* Ongoing or previous training (within the last year) at OsteoStrong.
Prevention of Sepsis-related Organ Dysfunction With Allocetra-OTS

The trial evaluates the safety and efficacy of one and two doses of the study drug, Allocetra-OTS, in patients who have been diagnosed with sepsis.

The study drug, Allocetra-OTS is a cell-based therapeutic composed of donor apoptotic cells. The product contains allogeneic mononuclear enriched cells in the form of a liquid suspension with at least 40% early apoptotic cells. The study drug, Allocetra-OTS, is based on the known activity of apoptotic cells to contribute to maintenance of peripheral immune homeostasis. As altered immune response is associated with organ dysfunction in sepsis, the possibility is being tested that the study drug can improve the condition of sepsis.

Eligibility Criteria:
Inclusion Criteria:

* Suspected, presumed or documented infection from any source.
* Initiation of antibiotics.
* Meets Sepsis 3 criteria: The presence of organ dysfunction as identified by a total SOFA score ≥ 2 points above baseline.
* Adult male or female, age between 18 and 85.
* GCS of \>13 with verbal score of 5.
* Signed written informed consent by the patient.

Exclusion Criteria:

* Participation in an interventional investigational trial within 30 days prior to diagnosis of sepsis.
* Significant trauma requiring hospitalization within 30 days prior to diagnosis of sepsis.
* Surgical intervention or hospitalization within 45 days prior to diagnosis of sepsis.
* Pregnancy or breast-feeding female.
* Progressive or poorly-controlled malignancies or \< 6 month after active treatment for cancer (chemotherapy or irradiation).
* Terminally ill patients defined as patients that prior to the current hospitalization are expected to live \< 6 months (as assessed by the physician responsible for the patient).
* Known active acute or chronic viral infections, e.g. Hepatitis B Virus (HBV) or Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV) or other chronic infection.
* Known severe chronic respiratory health problems with severe pulmonary hypertension (≥40 mmHg) or respirator dependency.
* Known active upper gastrointestinal (GI) tract ulceration or hepatic dysfunction including but not limited to: biopsy-proven cirrhosis; portal hypertension; episodes of past upper GI bleeding attributed to portal hypertension; or prior episodes of hepatic failure, encephalopathy, or coma.
* Known New York Heart Association (NYHA) class IV heart failure or unstable angina, ventricular arrhythmias, active ischemic heart disease, or myocardial infarction within six months prior to diagnosis of sepsis.
* Known immunocompromised state or medications known to be immunosuppressive.
* Organ allograft or previous history of stem cell transplantation