cyrilzakka/clinical-trials huggingface dataset:
The Effect of +3.00ADD on Myopia Progression in Chinese Children

The purpose of this study is to evaluate the effect of +3.00ADD vs single vision spectacle on the progression of myopia in children. Many studies applying bifocals or multifocal spectacles to intervene the progression have been carried out based on the idea that myopia was caused by excessive accommodation, however, the effect was limited. The possible reason is that bifocal or multifocal spectacles still not fully adjust the accommodative error in myopia children.

The optical intervention has been extensively explored for the intervention of myopia progression.

Based on the theory that myopia was caused by the excessive accommodative, bifocal or multifocal spectacles for slowing the progression of myopia have been fully studied. Although some studies' results showed statistically significant for slowing myopia progression with multifocal spectacles, few had clinically meaningful, even in children with high accommodative lag or near-point esophoria. The investigators think that the possible reason for this clinical un-meaningful maybe that daily wearing bifocal or multifocal spectacles still not fully adjust the accommodative error in children.

The aim of this randomized clinical trial is to evaluate myopic progression in children using two spectacles (single-vision spectacles for distant vision, and +3.00ADD spectacle for near vision), compared with control subjects wearing one spectacles (single-vision spectacles). Myopia progression quantified by changes in axial length (AL) and cycloplegic spherical equivalent refraction will be monitored for 3 years. The spectacles for intervention group children will be adjusted based on the cycloplegic spherical equivalent and the extent of accommodation lag for schedule time.

Eligibility Criteria:
Inclusion criteria

1. Children who are aged 8 to 12 years (grade 3 and grade 4) from Huadu district of Guangzhou in China.
2. Refractive error meeting all the following, obtained by cycloplegic autorefraction: spherical equivalent -1.00 to -6.00D in both eyes, astigmatism ≤2.00 D in both eyes, and spherical equivalent anisometropia ≤1.50 D.
3. The best corrected visual acuity is ≥ 6/9.5
4. The parents are willing to provide consent to participation in the study, and the children are willing to wear the only provided spectacles

Exclusion criteria

1. Children who are allergy to tropicamide or topical anesthetic drugs.
2. Children who had other eye diseases that cause the visual impairment including strabismus, amblyopia, ocular surface related disease, cataract, traumas, ocular fundus diseases, and ocular surgery.
3. Children who were wearing rigid gas permeable contact lenses, progressive-addition lenses, bifocal spectacles lens, Peripheral defocus modifying contact lenses;
4. Children who are receiving visual function training.
Molehill Mountain Feasibility Study.

Up to half of autistic people experience anxiety symptoms, which can have a significant impact on everyday wellbeing. However, there are currently very few effective, evidence-based interventions to support autistic people in managing anxiety; and many autistic people face barriers in accessing inperson health and social care services. Therefore, developing new interventions (and/ or adapting existing ones) that improve anxiety, in a way that meets the needs of autistic people, represents the autism community's number one priority for research and clinical practice.

Addressing this priority, the investigators will test the acceptability and feasibility of a new, app-based therapeutic approach for anxiety ('Molehill Mountain') that has been developed with, and adapted for, autistic people aged 12-years and over using adapted Cognitive Behavioural therapy principles. This means that information will be collected from autistic people accessing clinical services on whether they would choose to use the anxiety app, whether the app is simple to administer and use, how it is used, how it can be improved, and whether it is effective in reducing anxiety symptoms and/ or enhancing other outcomes, such as everyday wellbeing and functioning.

The evidence from this project will inform the future optimisation and implementation of Molehill Mountain in a randomised-controlled trial, with the ultimate aim of transforming long-term healthcare delivery for autistic people.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 16-years.
* Autism diagnosis.
* Current mild-to-severe anxiety symptom severity, as assessed at screening (and currently in touch with mental health services e.g., referred, on the waitlist).
* Able and willing to provide verbal and written informed consent to take part in the study.
* Access to Molehill Mountain app via SmartPhone or other Smart device.

Exclusion Criteria:

* Difficulties with reading/ writing to the extent that the app is inaccessible.
* High risk of self-harm that make participation in the study inappropriate for the individual's current level of clinical need (as assessed by clinical team).
* Attended ≥ 6 sessions of individual or group therapy (e.g., cognitive behavioural therapy) in the past 6-months, which would make it impossible to parse out the effects of the app from existing therapy.
* If using psychotropic medication, this medication/ dose must have been stable for a minimum of 8-weeks on entry to the study.
Safety and Efficacy of Eszopiclone in Patients With Generalized Anxiety Disorder

To determine the safety and efficacy of eszopiclone as adjunctive therapy in the treatment of insomnia in patients with insomnia related to Generalized Anxiety Disorder. All subjects will receive an approved anxiolytic agent and will be randomized to nightly therapy with either eszopiclone or placebo.

An 8-week, randomized, double-blind, placebo-controlled, parallel-group adjunctive therapy trial. The study consists of subjects with insomnia related to Generalized Anxiety Disorder who will be treated for 10 weeks with open-label escitalopram oxalate 10 mg/day at bedtime, and randomized to receive either eszopiclone 3 mg nightly or placebo nightly for 8 weeks. This study was previously posted by Sepracor Inc. In October 2009, Sepracor Inc. was acquired by Dainippon Sumitomo Pharma., and in October 2010, Sepracor Inc's name was changed to Sunovion Pharmaceuticals Inc.

Eligibility Criteria:
* Subjects, between the ages of 18 and 64 years inclusive
* Subjects with Generalized Anxiety Disorder (GAD)
* Subjects with insomnia related to GAD.
Ultrasound Use for Difficult Lumbar Punctures in Pediatric Oncology Patients

Hematology-oncology patients may require frequent lumbar puncture for diagnosis, assessment and therapy. When LP is difficult, the patient may endure multiple attempts, prolonged anesthesia time, and with failure of LP may require fluoroscopy-guidance with associated radiation exposure. This investigation will evaluate lumbar punctures performed in the intraoperative setting by oncologists with ultrasound guidance performed by the anesthesiologist in the leukemic pediatric population. The investigators hypothesis is that anesthesiologist guided ultrasound assistance will decrease intraoperative time, number of attempts and need to have the procedure done with fluoroscopy minimizing radiation exposure.


Eligibility Criteria:
Inclusion Criteria:

* All patients undergoing LP as per Heme-Onc clinic who have been deemed to be difficult LP placements.

Exclusion Criteria:

* Patients having concomitant procedures (bone marrow bx, etc.)
Vaccine Therapy in Treating Patients With Advanced Cancer

RATIONALE: Vaccines may make the body build an immune response to kill tumor cells.

PURPOSE: Phase I trial to study the effectiveness of vaccine therapy in treating patients who have advanced cancer.

OBJECTIVES: I. Determine the safety, tolerance, and maximum tolerated dose of TG4010 in patients with MUC1 positive advanced cancer. II. Determine the biological and immunological effects of this regimen in this patient population.

OUTLINE: This is a dose escalation study. Patients receive TG4010 IM weekly for 4 weeks, every other week for 8 weeks, and then every 4 weeks. Treatment continues every 4 weeks in the absence of unacceptable toxicity or disease progression. Cohorts of 3-6 patients receive escalating doses of TG4010 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 3 of 6 patients experience treatment related grade 3 toxicity. If any patient experiences grade 4 toxicity, the prior dose level is considered the MTD.

PROJECTED ACCRUAL: A total of 10 patients will be accrued for this study within 4 months.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Histologically confirmed cancer not amenable to cure by any standard modality and not suitable for accepted palliative care with chemotherapy, immunotherapy, or hormonal therapy Histologically confirmed MUC1 antigen expression No uncontrolled or symptomatic CNS metastases

PATIENT CHARACTERISTICS: Age: 18 and over Performance status: ECOG 0-2 Life expectancy: At least 3 months Hematopoietic: Hemoglobin at least 9.0 g/dL WBC at least 3,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 2 times upper limit of normal (ULN) Transaminase no greater than 3 times ULN (unless attributable to metastatic disease) Renal: Creatinine no greater than 2 times ULN Other: Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception during and for 3 months after study HIV negative No active systemic infections No other serious concurrent systemic medical disorders that would preclude study compliance No history of, or immediate household contact with, eczema, exfoliative skin disorders, pregnant women, children under 3 years of age, or other immunocompromise offering an increased risk for disseminated vaccinia infection

PRIOR CONCURRENT THERAPY: Biologic therapy: See Disease Characteristics Chemotherapy: See Disease Characteristics At least 3 weeks since prior chemotherapy (6 weeks for nitrosamines and mitomycin) No concurrent chemotherapy Endocrine therapy: See Disease Characteristics No concurrent systemic corticosteroid therapy No concurrent hormonal therapy Radiotherapy: See Disease Characteristics At least 3 weeks since prior radiotherapy No concurrent radiotherapy Surgery: See Disease Characteristics Other: No concurrent immunosuppressive drugs No other concurrent experimental protocol No other concurrent antitumor therapy
SAM - Skip a Meal - Insulin Glargine, Diabetes Mellitus Type 1

Primary objective:

To compare metabolic control as measured by Blood Glucose (BG) upon arising from bed (7:00 am - 12:00 pm) in type 1 Diabetes mellitus patients who skip the morning meal during treatment with MDI basal/bolus insulin: Difference of change of blood glucose between 7:00 am and 11:00 am between patients on Insulin glargine and NPH insulin.

Secondary objective:

To perform an evaluation between the two patient groups for BG (10:00 pm and 12:00 pm) as well as for serum insulin, free fatty acid levels and β-hydroxybutyrate (7:00 am - 12:00 pm).


Eligibility Criteria:
Inclusion Criteria:

Patients with type 1 Diabetes mellitus who have been treated with MDI (Multiple Daily Injection) basal/bolus insulin, regular insulin/short acting insulin analogue + NPH insulin on a stable dose (no change more than 10 %) for at least 4 weeks prior to study entry, who have an HBA1c smaller/equal 9 % (measured at visit 1) and a BMI smaller/equal 35 kg/m2. In addition, patients must have a FBG value at day 1 before skipping meal (6:00 am - 07:00 am) between 90 - 120 mg/dl (5.0 - 6.5 mmol/l).

Exclusion Criteria:

* Breast-feeding
* History of hypersensitivity to the study medication or to drugs with similar chemical structures
* Likelihood of requiring treatment during the study period with drugs not permitted by the study protocol
* Treatment with any investigational drug in the last 30 days before study entry
* Clinically relevant cardiovascular, hepatic, neurological, endocrine, or other major systemic disease making implementation of the protocol or interpretation of the study results difficult
* History of drug or alcohol abuse

No subjects who have previously been treated with Insulin glargine will be enrolled in this study.
Dapagliflozin in Physical Exercise in Type 1 Diabetes

Inhibitors of sodium-dependent glucose-transporter 2 (SGLT-2 inhibitors, including dapagliflozin) inhibit glucose reabsorption in renal tubular cells, hereby increasing glycosuria in the hyperglycemic state. Its mechanisms of action are independent of insulin, which makes SGLT-2 inhibitors a potential adjunct to insulin in type 1 diabetes mellitus (T1DM).

However, a higher risk for diabetic ketoacidosis (DKA) was reported in patients with T1DM taking SGLT-2 inhibitors. DKA depends on an accumulation of ketone bodies in the blood stream, which equals an accumulation of acids that lead to acidosis. The underlying mechanisms of this observation are unknown. Ketone body production depends on the molar ratio of glucagon to insulin, with insulin suppressing but glucagon stimulating ketone body production. This translates into higher production during relative insulin deficiency, carbohydrate deficiency, and prolonged fasting, which occurs during sickness but also physical exercise. Physical exercise is a recommended cornerstone in the treatment of T1DM and current treatment guidelines recommend both, reductions of insulin doses and ingestion of additional carbohydrates to avoid hypoglycemic events. These adaptions might increase relative insulin deficiency, hyperglycemia and glycaemic variability, which might in turn promote ketone body production. The addition of SGLT-2 inhibitors further may promote ketogenesis even though there are reports of SGLT-2 inhibitors increase Glucagon-like-peptide-1 (GLP-1) in patients with T1DM. GLP-1 is a suppressor of glucagon secretion. In summary, knowledge about the effects of SGLT-2 inhibition on ketone body production is scarce, especially during exercise in patients with T1DM.

The study seeks to illustrate the effect of SGLT-2 inhibition on glycemic variability and ketone body production during and after recreational exercise in patients with T1DM. The results of study 2 will provide the basis for future studies investigating the underlying mechanisms of potentially modified ketone body production during and after exercise under SGLT-2 inhibition.


Eligibility Criteria:
Inclusion Criteria:

* Written informed consent
* Diagnosis of T1DM
* Duration of T1DM \> 5 years
* Male or female sex
* Insulin therapy via multiple daily injections (MDI) or continuous subcutaneous insulin infusion (CSII)
* Body mass index (BMI) between 20 and 29 kg/m2
* Adherence to sufficient contraceptive measures (double barrier method combining hormonal with mechanical barriers).
* Ability to perform a 60 minutes exercise session at 50% VO2max.

Exclusion Criteria:

* Diagnosis of renal and/or hepatic dysfunction
* History of malignancy of any kind
* Intake of drugs influencing glucose homeostasis during the last three months
* Alcohol or drug abuse
* Inadequate vein status on both forearms
* Active smoker
* Known pregnancy, positive plasma beta human choriogonadotropine test prior to study inclusion or intention to become pregnant during the study period.
Comparison of Hemodynamic Stability During Anesthesia Using Remimazolam and Sevoflurane in Minimally Invasive AVR

Anesthetic agents can cause hypotension, and be especially dangerous in patients with severe aortic stenosis, which can lead to even circulatory collapse. Remimazolam is known for its hemodynamic stability compared to propofol. This study is designed to compare effects of remimazolam vs. sevoflurane anesthesia on intraoperative hemodynamics in patients with severe aortic valve stenosis.

Anesthetic agents can cause hypotension due to reduced cardiac contractility and vasodilation. This can be especially dangerous in patients with severe aortic stenosis, which can lead to even circulatory collapse in extreme cases. Remimazolam is a relatively new anesthetic agent and it is a ultra-short acting benzodiazepine with a context sensitive half time of 7.5 minutes. Remimazolam is known for its hemodynamic stability compared to propofol. Previous studies have also shown that remimazolam can be safely used in patients with severe aortic stenosis and in cardiac anesthesia induction and during cardiopulmonary bypass. However, there is no definite data on comparison of hemodynamic variables between remimazolam based total intravenous anesthesia (TIVA) and conventional propofol induction and sevoflurane maintenance anesthesia. Therefore, this study is designed to compare effects of remimazolam vs. sevoflurane anesthesia on intraoperative hemodynamics in patients undergoing minimally invasive aortic valve replacement surgery.

Eligibility Criteria:
Inclusion Criteria:

* Patients over 19 years old
* Patients with severe aortic stenosis, undergoing minimally invasive aortic valve replacement surgery

Exclusion Criteria:

* Patients with known allergy to benzodiazepine, flumazenil, propofol
* Patients with galactose intolerance, Lapp lactase deficiency, glucose-galactose malabsorption
* Patients with hypersensitivity to Dextran40
* Patients who have been taking benzodiazepine for long term
* Patients with whom heart rate assessment is not accurate, such as atrial fibrillation
* Patients with end stage renal disease requiring hemodialysis
* Patients with history of acute angle glaucoma
* Patients with valve disease severity of grade III or higher, other than aortic valve
* Emergency operation
Maternal Telemental Health Interventions in Response to Covid-19*

The purpose of this study is to assess the effectiveness of a telemental health intervention on the mental health of pregnant women during the COVID-19 crisis in Qatar.

A list of potential participants, including contact information, will be extracted from Women Wellness and Research Center's registry. A probability sampling technique (simple random selection) will be employed to randomly select (Automated Random Number Generator) the potential participants. Then, the potential participants will be contacted and informed about the study. After consenting to participate, they will be screened for eligibility. The pregnant women who met the inclusion criteria will be enrolled and followed up until nine months after delivery. The contact details of each participant will be written on a paper and sealed in an envelope marked with either letter A or B. Upon enrolment, the participants will be randomized equally with a block size of two into two parallel arms. The pregnant women in the interventional arm will receive six sessions of a low-intensity psychosocial intervention through telemental health consultations with a trained psychologist. On the other hand, those in the control arm will not receive any intervention. The participants in both arms will be screened for psychological distress (six times) over the study period.

Eligibility Criteria:
Inclusion Criteria:

1. All pregnant women of reproductive age (18- 49) years old in the second trimester that agree and consent to receive teleconsultation.
2. No specific nationality restriction.
3. Language communicated English and Arabic.
4. Able to cooperate with data collection procedure.

Exclusion Criteria:

1. Pregnant women with psychiatric illness and following up at Sidra or HMC mental services.
2. Pregnant women receiving mental health medications (antidepressants.)
3. Cannot communicate in English or Arabic.
4. Didn't consent.
IMRT vs 2DRT for NPC Patients

Irradiation of the parotid gland with subsequent long-term xerostomia is a well-recognized complication after radiotherapy for head and neck (HAN) cancers. A number of studies have shown that IMRT could minimize the radiation dose to the parotid glands and hence the risk of developing xerostomia. The benefit of IMRT has also been demonstrated in prior dosimetric and non-randomized studies in NPC patients. In 2007, the investigators have published the prospective randomized study of IMRT versus 2DRT in early stage NPC patients. In the study, IMRT had lower incidence of observer-rated severe xerostomia, higher parotid and whole saliva flow rate, than patients in 2DRT arm at 1 year after treatment. However, there was no significant difference in patient-reported outcome, i.e. subjective xerostomia scoring, between the 2 arms. The underlying reason for the incoherent findings in terms of objective and subjective xerostomia outcome remains uncertain. One of the possible explanations for this observation could be the better parotidsparing with IMRT alone may not entirely sufficient to maintain oral cavity lubrication while the other mucin-secretory salivary gland protection is also essential. Another possible explanation for the insignificant improvement in patient-reported outcome with IMRT is the short follow-up time. Gradual recovery or improvement in various quality of life parameters was not uncommonly seen several years after definitive radiotherapy for HAN cancer patients. There is much interest in studying the long term clinical outcome, especially the treatment-related complications, for the patients who had randomized and treated in the prior presented prospective study.

In this study, the long term results, in particular the xerostomia rating will be assessed and compared in NPC patients who had participated in the prior reported prospective randomized study of IMRT vs 2DRT.


Eligibility Criteria:
Inclusion Criteria:

* The NPC patient, who had been enrolled, randomized and treated in the prior prospective randomized study of IMRT vs 2DRT.
* Regular follow-up for more than five years from the end of study intervention (i.e. IMRT or 2DRT for NPC).
* Patient is able to sign the study-specific informed consent.
* ECOG performance status 0 or 1.
* Patient is able to complete the study's questionnaire.

Exclusion Criteria:

* NPC patients who had not been randomized or allocated to the study intervention, even though had been enrolled in the prior reported study.
* Loss of regular follow-up from the end of study intervention.
* Regular follow-up for less than five years from the end of study intervention.
* Patients with known recurrent or metastatic disease.
* Patients with secondary malignancy occurred after completion of the previous study's treatment (i.e. radiotherapy).
* Active untreated infections
* Major medical or psychiatric illness
Safety and Efficacy Study of an Ophthalmic Solution in Patients With Age-Related Cataract

The purpose of this study is to determine the safety and efficacy of C-KAD Ophthalmic Solution in improving visual acuity relative to placebo in patients with age-related cataract


Eligibility Criteria:
Inclusion Criteria:

* Presence of age-related cataract in the study eye
* Best-corrected visual acuity of 20/25 to 20/50 in the study eye

Exclusion Criteria:

* Any other clinical condition in the eye that may compromise vision
* Presence or History of Glaucoma
* Presence or history of diabetes
* Use of eyedrops
* Use of steroids