cyrilzakka/clinical-trials huggingface dataset:
To Evaluate the Efficacy and Safety of Multifocal Soft Contact Lens in Myopia Control

The objective of this study is to investigate the efficacy and safety of soft lens in myopia control.

This is a prospective, randomized, paired eye comparison, double-blind study aims to evaluate the efficacy and safety of "Soft Lens" in myopia control among schoolchildren. A total of 118 eyes are planned to be enrolled and the expect duration of subject participation will be 48 weeks not including two weeks of screening period. Data such as refractive error, axial length, visual acuity, average wearing hours, self-assessment, adverse events etc. will be collected during the study. A total of 10 visits, i.e. a screening visit, a randomization visit, and 8 treatment visits are planned. Subjects will be encouraged to complete all planned visits.

Eligibility Criteria:
Inclusion Criteria:

1. Both genders aged between 6 and 15 years
2. Spherical equivalent refractive error between -1.00D and -10.00D
3. Visual acuity with contact lens of 20/25 or better in each eye
4. Astigmatism less than or equal to 1.50D
5. Anisometropia less than or equal to 1.00D
6. Agree to wear assigned contact lens and able to comply with the study protocol
7. Subjects and/or their legal representatives agree to sign informed consent form

Exclusion Criteria:

1. Eye disease or vision problem that may contraindicate/interfere with contact lens wearing, for example:

   1. Amblyopia
   2. Severe strabismus at investigator's discretion
   3. Pathologically dry eye
   4. Aphakia
   5. Slit lamp findings including but not limited to corneal edema, corneal ulcer, bulbar redness that are more serious than grade 1
   6. Currently ocular infection of any type or inflammation in either eye
   7. Oculomotor nerve palsies
   8. Pupil or lid abnormality in either eye
   9. Severe ocular allergy
   10. Anterior segment infection, inflammation or abnormality
   11. Corneal vascularization greater than 1 mm of penetration
   12. History of herpetic keratitis
2. Use of bifocals, progressive addition lenses, rigid gas permeable contact lenses, orthokeratology lenses, atropine, pirenzepine or any other myopia control treatment within 1 month prior to screening visit
3. Systemic disease that may affect vision or contact lens wearing (e.g. diabetes, Down syndrome), autoimmune disease, infectious disease, or immunosuppressive diseases recorded in medical charts or informed by caregiver
4. Surgically altered eyes (e.g. corneal or refractive surgery, not including stye removal surgery)
5. Receiving any medication for long-term use which may interfere with contact lens wearing, tear film production, pupil size, accommodation or refractive state, such as nasal decongestants (e.g. pseudoephedrine, phenylephrine), antihistamines (e.g. chlorpheniramine, diphenhydramine), Prednisolone or Ritalin (methyphenidate)
Clinical Study Comparing Dental Plaque and Gingivitis Reduction After Using One of Three Oral Hygiene Multi-component Regimens (Using of a Manual Toothbrush, a Toothpaste and a Mouthwash)

The objective of this clinical research study is to assess the efficacy of a commercially available triclosan/copolymer toothpaste compared to a commercially available oral hygiene multi-component regimen encompassing the use of a manual toothbrush, a toothpaste containing stannous fluoride / sodium hexametaphosphate and a mouthwash containing cetylpyridinium chloride relative to a negative control regimen in reducing established dental plaque and gingivitis over three and six months of assigned product use.


Eligibility Criteria:
Inclusion Criteria:

1. Male and female subjects, ages 18-70, inclusive.
2. Availability for the six-month duration of the study.
3. Good general health.
4. Minimum of 20 uncrowned permanent natural teeth (excluding third molars).
5. Initial gingivitis index of at least 1.0 as determined by the use of the Loe and Silness Gingival Index.
6. Initial plaque index of at least 1.5 as determined by the use of the Quigley and Hein Plaque Index (Turesky Modification).
7. Signed Informed Consent Form.

Exclusion Criteria:

1. Presence of orthodontic bands.
2. Presence of partial removable dentures.
3. Tumor(s) of the soft or hard tissues of the oral cavity.
4. Advanced periodontal disease (purulent exudate, tooth mobility, and/or extensive loss of periodontal attachment or alveolar bone).
5. Five or more carious lesions requiring immediate restorative treatment.
6. Use of antibiotics any time during the one month prior to entry into the study.
7. Participation in any other clinical study or test panel within the one month prior to entry into the study.
8. Pregnant women or women who are breast feeding.
9. Dental prophylaxis received in the past two weeks prior to baseline examinations.
10. History of allergies to oral care/personal care consumer products or their ingredients.
11. On any prescription medicines that might interfere with the study outcome.
12. An existing medical condition which prohibits eating or drinking for periods up to 4 hours.
13. History of alcohol or drug abuse
Influence of Wrap Fixation Technique on the Results of Fundoplication

Patients who underwent anti-reflux surgery were divided into two groups. In the I group Nissen fundoplication was supplemented with suturing wrap to the crura or the body of stomach using two non-absorbable stitches on each side. Control group included patients who underwent classic Nissen fundoplication without wrap fixation. All patients were assessed before and after surgery using validated symptoms and quality of life (GERD-HRQL) questionnaires, 24-h impedance-pH monitoring and barium-swallow.


Eligibility Criteria:
Inclusion Criteria:

* Age: 20 - 80 years;
* Gastroesophageal reflux disease as evidence by gastroscopy and pH-monitoring;
* HH type I, II

Exclusion Criteria:

* Age \< 20 years and \> 80 years;
* Unable to undergo laparoscopic fundoplication due to: severe comorbidities (ASA III and more), previous major surgery with severe adhesions, etc.;
* HH type III, IV;
* BMI \< 16 and \> 45 kg/m²;
* Pregnancy (in females);
* Oesophageal motility disorders;
* Oesophageal peptic strictures;
* Oesophageal diverticula, other types (i.e. non-reflux) of chronic esophagitis, connective tissue disorders (e.g. scleroderma);
* History of oesophageal/gastric/duodenal surgery including vagotomy;
* Relapsing course of ulcer disease/hyperacid gastritis including complicated by delayed gastric/duodenal emptying
Quasi-Randomized Evaluation of the UCLA Next Day Clinic (NDC)

The Next Day Clinic (NDC) is a quality improvement initiative that will be launched and operated by UCLA Health starting July 22, 2024. Its goals are to improve patient care and safety and to maximize cost effectiveness. The way it does this is by identifying patients in the ED who would normally be admitted for low-acuity conditions, and diverting them to a high-acuity clinic the following day called the NDC. This will help decompress the ED and the hospital, and allow for overall higher quality care. The Health System has partnered with UCLA's Healthcare Value Analytics and Solutions \[UVAS\] group which specializes in these types of program evaluations. The analysis conducted by the study team will be used to directly inform NDC operations, scaling, and future plans.

NDC is a hospital avoidance model with the potential to simultaneously improve the quality and safety of acute care, reduce costs, and address hospital/ED overcrowding. This novel hospital avoidance program will divert patients from the ED who have been diagnosed with the following conditions and meet certain clinical criteria:

* Diabetic Foot Infection/Osteomyelitis
* Cellulitis
* Congestive Heart Failure
* Syncope
* Pyelonephritis/Urinary Tract Infection
* Pneumonia
* Acute Kidney Infection

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* About to be admitted through the ED for one of the NDC diagnoses or a synonym (per Study Protocol document), defined by the presence of a Plan to Admit order or Bed Request order, OR recently admitted under observation or inpatient status for one of the NDC diagnoses.
* Identified as at-risk for an avoidable hospitalization in the ED based on a pre-determined set of lab and vital parameters.
* Insurance that authorizes the patient to follow-up at UCLA Health, or self-pay
* Admitted or being admitted to an internal medicine service

Exclusion Criteria:

* Heart or lung transplant recipient with concern for graft dysfunction
* Pregnant
* Enrolled in hospice
* Resides in or discharged to a skilled nursing facility/acute rehabilitation facility
* Admitted to a critical care service
* ED deems discharge unsafe due to complex social or medical factors
* Active malignant cancer (per Council of State and Territorial Epidemiologists value set)
* Pulmonary arterial hypertension (per Joint Commission value set)
* Undergoing workup for solid organ transplant
* Interstitial lung disease (including pulmonary fibrosis) (per Higher Level 7 value set)
* Requiring inpatient procedure or surgery defined by the presence of an anesthesia event or operating room encounter.
* The ED deems discharge unsafe due to complex social or medical factors.
* Transferred to an ineligible hospital

Note:

The Health System plans to limit the volume of referrals to the NDC by only referring patients who have an even birth date (this is more equitable than first-come-first-serve, because wage workers are more likely to come to the ED later in the day; even/odd birth date theoretically keeps more spots open for patients presenting to the ED later).
Study of DC-CIK to Treat NPC

Concurrent of radiotherapy and chemotherapy is the main treatment method for patients with nasopharyngeal carcinoma (NPC). However, Relapse remains the major cause of treatment failure. A series of studies reported that dendritic and cytokine-induced killer cells (DC-CIK) have a broad anti-tumor spectrum. We suppose that DC-CIK will improve the prognosis of NPC. In this study, the patients with NPC will be treated with DC-CIK cells after concurrent of chemotherapy and radiotherapy. The purpose of this study is to evaluate the efficacy of DC-CIK for NPC.

About 60 patients with staging Ⅱ-Ⅲ of NPC, after accepting concurrent radiotherapy and chemotherapy, will be randomly divided into group A (receive DC-CIK treatment) or group B (just regularly follow up), and the randomize ratio will be 1:1. Patients in group A will receive 2-3 cycles of DC-CIK cells treatment (every 4 weeks). Patients in group B will have no anti-tumor therapy.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with staging Ⅱ-Ⅲ of NPC;
2. Patients who had completed concurrent of radiotherapy and chemotherapy;
3. Patients who have a life expectancy of at least 12 weeks;
4. Eastern Cooperative Oncology Group (ECOG) performance status was 0-1;
5. The bone marrow functioned normally (WBC \> 4.0×109/L, Hb \> 120 g/L, PLT \> 100×109/L);
6. The ECG results were normal, and the liver and kidney were functional.

Exclusion Criteria:

1. Patients who had distant metastases by imaging studies;
2. Patients with uncontrolled infection; underlying disease that was severe or life-threatening;
3. Patients who were pregnant or lactating;
4. ECOG perform status ≥ 2;
5. Patients who are suffering from auto immune diseases or patients who need to accept glucocorticoid treatment.
Psychotherapy of Generalized Anxiety Disorder

The purpose of this study is to compare the effects of worry exposure with the effects of applied relaxation in patients with generalized anxiety disorder.

Controlled treatment studies show that there is a lower efficacy of cognitive-behavioral treatment of generalized anxiety disorder (GAD) than in other anxiety disorders. The best effect sizes are found for applied relaxation (Öst), but there are only three treatment studies. Another, yet previously not tested in its pure form, approach is "worry-exposure", which aims at confronting the emotionally intensive imaginative contents of worries in GAD.

Fifty-two randomized patients with GAD as a primary diagnosis will be treated with one of the two treatments and will be compared with waiting-list patients. This treatment protocol contains 15 sessions (+/-2) and a 6 month and 12 month follow-up.

The comparisons in this study include: worry exposure versus applied relaxation versus a waiting control group.

Eligibility Criteria:
Inclusion Criteria:

* Primary Diagnosis of generalized anxiety disorder (according to impairment)
* 18-70 years of age
* Informed consent

Exclusion Criteria:

* Not able to understand and speak the German language
* Acute, unstable and severe somatic disease (DSM-IV, Axis III)
* History of schizophrenia or bipolar disorder
* Other mental disorders requiring treatment
* Substance dependence within the past 12 months preceding treatment
* Personality disorders that interfere with treatment compliance
* Participation in any other psychotherapeutic interventions
* Use of anxiolytics (e.g. tranquilizer, hypnotics, neuroleptics; does not include stabile use of antidepressants)
Proximity Alarms to Reduce Patient Falls

The purpose of this study is to test an intervention to introduce and implement proximity alarms on the risk of falls in hospitalized patients.

Proximity alarm systems are promoted as an approach to reduce falls and decrease use of physical restraints in hospitals, but they have not been tested rigorously. This study will implement proximity alarms at Methodist-University Hospital (M-UH), a 652-bed urban community hospital in Memphis, Tennessee. The hospital provides primary to tertiary care to a diverse adult patient population. The group randomized trial will be conducted on 16 25-bed general medical-surgical nursing units at M-UH. Nursing units will be randomized within blocks of 2 based on rates of falls that occur during an initial 3-month observation period. Over a 15-month intervention, 8 nursing units will be randomized to receive the alarm-based intervention, and 8 will utilize existing nursing care methods to minimize falls. Intervention units will receive an adequate supply of proximity alarm monitoring systems to apply to all patients considered by nursing staff to be at high risk for falls. An implementation team, consisting of a nurse-champion, geriatrician and biomedical instrumentation specialist, will train and conduct regular follow-up on intervention units to address technical issues related to use of the alarms. The primary outcome measure, patient falls, will be ascertained prospectively by a nurse-manager using a method developed to collect patient (e.g., orientation and postural blood pressure) and environmental data collected in a standardized manner. The primary aim of the study is to determine whether proximity alarm monitoring reduces falls. The study has been designed to test the hypothesis that patient falls will be 25% lower on intervention units compared to control units. The secondary aims are to determine whether proximity alarm monitoring reduces the use of physical restraints, or decreases patient care costs. This will be the first methodologically sound study to evaluate this promising approach to reducing falls in hospitals. Whether or not alarms successfully reduce falls, findings from this study have the potential to widely impact purchasing decisions and clinical practice related to fall prevention in acute-care settings.

Eligibility Criteria:
Inclusion Criteria:

* Patient admitted to one of 16 study units at Methodist University Hospital
The Impact of Malnutrition on Immune Responses to Tuberculosis

The aim of this study is to assess immune responses to Mtb in children with MAM compared to well-nourished children and to evaluate the impact of a nutrition intervention on these immune responses.

Immune dysfunction in malnourished children is poorly characterised. The aim of this study is to assess immune responses to Mycobacterium tuberculosis (Mtb) in children with moderate acute malnutrition (MAM) compared to wellnourished children and to evaluate the impact of a nutrition intervention on these immune responses. Innate and adaptive immune responses to Mtb will be characterised in four groups: 1) MAM children with TB disease; 2) Wellnourished children with TB disease; 3) MAM children with latent TB infection; 4) Well-nourished children with latent TB infection. A range of assays to compare innate, adaptive and functional immune responses to TB between groups will be performed. Whether nutritional supplementation improves immune function in MAM children remains uncertain. Hence, children in all four groups will be followed up during 6 months of TB therapy/chemoprophylaxis. MAM children will receive 12 weeks of concomitant ready-to-use supplementary food, to evaluate longitudinal changes in innate and adaptive immune function, monocyte:lymphocyte ratio and mycobacterial growth inhibition. The results of this study will provide data to understand the reasons for infection susceptibility in malnourished children and provide a proof-of-concept that nutritional rehabilitation promotes immune rehabilitation. It will also provide a proof-of concept for use of nutritional supplementation as adjust therapy in TB disease

Eligibility Criteria:
Inclusion Criteria:

* Age 12-60 months
* HIV-negative
* BCG vaccinated
* Moderate acute malnutrition (WHZ -2 to -3 or MUAC 115 - 125mm ± HAZ \<-2)
* TB disease
* Latent TB infection

Exclusion Criteria:

* Inclusion criteria not met
* Severe acute malnutrition (WHZ\<-3; MUAC\<115mm; bilateral oedema)
* Severe anaemia (Hb: \<7g/dl)
* Chronic infection (HIV, hepatitis B or C)
* Chronic disease (e.g. Crohn's disease)
* Feeding problems (eg cerebral palsy) that prevent ingestion of RUSF
* Known nut allergy
* MDR TB disease and contacts of MDR TB adults
Translating Neuroscience to Population Health

The current study will examine the relationship between brain responses and a guided imagery exercise in overweight and obese individuals. Results of this work are highly relevant to public health because they employ neuroimaging methods to understand food decision-making. Findings from this study will inform health decision making and holds great potential for future translation across multiple health behaviors and scalable interventions to impact population health

Negative health behaviors (e.g. overeating, smoking) are associated with increased negative health outcomes. Engaging in healthy behaviors is not always rewarding (e.g. carrot vs. cake). Neural models of healthy behaviors focus on the balance between reward and regulation brain regions. The current pilot application examines the engagement of these regions during the evaluation of food and nonfood cues before and after a guided imagery exercise targeting positive associations with food and regulation.

The long-term goal is to understand the interaction between positive associations with healthy foods and thinking about future rewards may influence healthy decision-making. The objective of the current study is to empirically test the combined effects of positive affect and positive episodic future thinking on brain activation.

Eligibility Criteria:
Inclusion Criteria:

* body mass index 25 to 55 kg/m2
* right-handed
* not currently dieting or attempting to lose weight.

Exclusion Criteria:

* serious medical illness unsuitable for the magnetic resonance imaging scanner based on best clinical judgment
* any neurologic or current psychiatric diagnosis
* currently taking anti-seizure medication
* history of concussion
* left-handedness
* risk for hazard due to magnetic fields such as metal in the body surgically or accidentally
* pregnancy
Collaborative Stepped-Care and Productive Ageing Program for Older People With Depressive Symptoms

The Jockey Club Holistic Support Project for Elderly Mental Wellness (JC JoyAge) has developed and implemented a collaborative stepped care model for older persons at-risk of or with depression in four districts in Hong Kong since 2015 (Clinical Trials Identifier: NCT03593889). Results from JC JoyAge show that the collaborative stepped-care model is effective in improving older persons' mental wellness, and the specialised training and engagement of Peer Supporters are effective in building capacity in the community. The proposed impact extension programme lasts for four years (from 2020 to 2023), and the overall goal is to expand the JC JoyAge model to all 18 districts in Hong Kong, to provide integrated and evidence-based mental health services to older adults with subclinical depressive symptoms, with the hope of model adoption in regular service upon project completion.

This four-year extension project includes three main elements: 1) Trainings, including different programmes for social services staff, Mental Wellness Ambassadors, and Peer Supporters; 2) Implementation of JoyAge service model: standardized collaborative stepped-care and Peer Support programmes for prevention and early intervention of depression in older adults; and 3) Public awareness campaign: coordinated programmes to increase mental health literacy and raise public awareness.

Specific goals of the programmes through the above three elements include:

1. To implement JC JoyAge clinical protocol and guidelines to coordinate care among community mental health and aged care services centres for elderly mental wellness in 18 districts;
2. To engage vulnerable and at-risk older adults in the community through productive ageing activities and mental wellbeing self-management training;
3. To enhance the capacity of social service staff in handling elderly depression through specialized and infusion training and knowledge exchange;
4. To raise public awareness and elderly mental health literacy among family members, neighbours, community stakeholders, and the general public to encourage early detection/help-seeking on depressive risk of older adults; and
5. To establish evidence of the effectiveness and cost-effectiveness of JC JoyAge Phase II model.

Eligibility Criteria:
Inclusion Criteria:

* age 60 years or above; and
* have depressive symptoms of mild level or above; and
* able to give informed consent to participate

Exclusion Criteria:

* known history of autism, intellectual disability, schizophrenia-spectrum disorder, bipolar disorder, Parkinson's disease, or dementia; and
* (temporary exclusion criteria) imminent suicidal risk; and
* difficulty in communication