cyrilzakka/clinical-trials huggingface dataset:
Clear Care® Plus vs. PeroxiClear™

The purpose of this study is to evaluate Clear Care® Plus compared to PeroxiClear™ for mean residual peroxide in used lens cases collected at Day 30 after neutralization at recommended storage time.

Participants will wear habitual lenses on a daily wear basis and use the assigned test solution for daily lens care.

Eligibility Criteria:
Inclusion Criteria:

* Sign informed consent form;
* Adapted, 2-week/monthly replacement silicone hydrogel contact lens wearers (at least 2 months);
* Willing to wear study lenses daily wear only on a daily basis (7 days per week and at least 4 hours per day) and attend all study visits;
* Symptoms of contact lens related dryness as defined by the Symptomatic Pre-Screening Questionnaire;
* Other protocol-specified inclusion criteria may apply.

Exclusion Criteria:

* Current hydrogen peroxide-based solution user;
* Routinely sleeps in lenses at least 1 night per week over the last 3 months prior to enrollment;
* Ocular anterior segment infection, inflammation, abnormality, or active disease that would contraindicate contact lens wear;
* Any systemic diseases that may affect the eye or be exacerbated by use of contact lenses or contact lens solutions or which could prevent wearing lenses at least 4 hours per day;
* Use of systemic or ocular medications for which contact lens wear could be contraindicated;
* Monocular (only 1 eye with functional vision) or fit with only 1 lens;
* History of herpetic keratitis, ocular surgery, or irregular cornea;
* Other protocol-specified exclusion criteria may apply.
Safety and Effectiveness of Wavefront-Guided LASIK Corrections of Myopic Refractive Errors

The purpose of this clinical trial is to demonstrate that wavefront-guided LASIK is safe and effective for the correction of myopic refractive errors.


Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or greater
* Best Spectacle Corrected Visual Acuity (BSCVA) of 20/20 or better
* Uncorrected visual acuity (UCVA) of 20/40 or worse
* Less than 0.75D difference between cycloplegic and manifest refraction sphere.
* Demonstration of refractive stability
* Anticipated post-operative stromal bed thickness of at least 250 microns
* Willing and capable of returning for follow-up examinations for the duration of the study.

Exclusion Criteria:

* Women who are pregnant, breast-feeding, or intend to become pregnant over the course of the study
* Concurrent use of topical or systemic medications that may impair healing
* History of any medical conditions that could affect wound healing
* History of prior intraocular or corneal surgery, active ophthalmic disease, or other ocular abnormality
* Evidence of keratoconus, corneal irregularity, or abnormal topography in the operative eye(s)
* Known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course
Perfusion CT Imaging in Lung Cancer With SBRT

The goal of this study is to determine specific perfusion patterns for radiation induced lung changes and residual/recurrent lung malignancies in patients treated with stereotactic body radiotherapy SBRT and thus improve to distinguish radiation changes from residual/recurrent lung cancers. Currently CT is often unable to make a clear differentiation between benign and malignant changes in the lung after SBRT treatment necessitating additional wait time to perform follow up CTs or biopsies. Optimal treatment may be delayed. The investigators want to apply a CT perfusion sequence in addition to the routine follow up CTs with the goal to obtain perfusion values of post treatment lung changes and lung tumours. The investigators' hypothesis is that CT perfusion values will help differentiate benign post radiation changes from residual/recurrent tumour in the lung with higher confidence and may help avoid unnecessary delays in cancer treatment.


Eligibility Criteria:
Inclusion Criteria:

* Gender: male or female
* CT ordered for baseline and follow up in patients with lung cancer and lung metastases treated with
* Patient will sign a consent form prior to study entry
* Lung cancer and lung metastases are biopsy proven

Exclusion Criteria:

* Patients who are unable to give valid informed consent
* Patients who are unwilling or unable to undergo a CT exam, including subjects with contra-indications to CT exams or intravenous contrast material administration.
Supplementation and Depressive Symptomatology Incidence Among Saudi Arabian Adults

The goal of this randomized controlled trial is to explore the relationship between Vitamin D supplementation and depressive symptomatology in Saudi Arabian Population.

The main questions it aims to answer are:

* Is Vitamin D deficiency associated with an increased prevalence of depressive symptomatology among Saudi Arabian Population?
* Is Vitamin D Supplementation for a period of 3-month at 50,000 International Units might be associated with an improved depressive status? All the participants were clients who attended the clinic to help with weight management - who were doing regular medical check-ups - at Al Themal Medical Center which is located in Abha, Saudi Arabia.

Participants were requested to do a general blood test to check for any vitamins and minerals deficiencies as part of the routine clinical procedure. This procedure did not incur any additional costs on the behalf of the participants. The participants who were identified to have any deficiencies were recommended to take supplements, also as part of the routine clinical procedure. Therefore, participants identified to be deficient or insufficient Vitamin D levels were screened and recruited to participate in the current study.

Participants were randomly assigned to either an interventional (vitamin D) or placebo group (control). The interventional group received vitamin D supplementation of 50.000International Units/week for 3 months and the placebo group received dietary advice and education on food sources of vitamin D for the same period. Both Groups received a weight gain or a weight loss diet as per their case.

At the three-months follow-up, the participants were readministered the face-to-face questionnaire and their blood levels for vitamin D were also checked.

Thus, this study would add value to the actions taken to treat vitamin D deficiency in Saudi Arabian adults. This might also assist in approaching new recommendations related to preventing or treating depression via vitamin D supplementation.


Eligibility Criteria:
Inclusion Criteria:

* Males and females Aged between 18 and 65 years old
* Be Vitamin D deficient/Insufficient (As tested via blood levels)
* Have a BMI between 17kg/m2 \& 55 kg/m2
* Able to understand Arabic
* Able to provide written consent

Exclusion Criteria:

* Participants already taking Vitamin D supplements or Anti-depressants
* Participants having normal vitamin D levels
* Participants reporting other mental health diseases
* Pregnant or lactating women.
Prevalence and Risk Factors for Venous Thromboembolic Events in Critically Ill Patients With COVID-19

The purpose of the study is to assess the frequency of the occurrence of a venous thrombosis in patients with the new Coronavirus disease, who are admitted to the Intensive Care Unit for impending respiratory failure requiring intubation and mechanical ventilation. Furthermore, the investigators aim at identifying potential risk factors for thrombosis and death.

Symptomatic infection with the severe acute respiratory syndrome coronavirus 2 ranges from mild to critical spectrum. About 80% of laboratory confirmed infections presented with mild symptoms, usually not requiring hospitalization. Critical disease requiring respiratory and/or circulatory support was reported in 5% of the subjects. Acute respiratory distress syndrome represents the most common complication in patients with severe disease. Several cases of venous thromboembolism in patients with laboratory confirmed infection have been reported, but it is unclear if this occurrence is higher in this specific patients' population. The purpose of the present study is to assess the prevalence of deep venous thrombosis in patients infected with SARS-CoV-2 admitted to the Intensive care Unit requiring invasive mechanical ventilation using vein ultrasonography.

Eligibility Criteria:
Inclusion Criteria:

* patients admitted to the Intensive Care Unit
* laboratory confirmed SARS-CoV-2 infection
* invasive respiratory support

Exclusion Criteria:

* none
Systemic Light Exposure in Preventing Frailty in Older Patients With Prostate Cancer on Hormonal Therapy

This pilot trial studies how well systemic light exposure works in preventing frailty in older patients with prostate cancer on hormonal therapy. Hormone therapy causes many symptoms of frailty in older men including fatigue, slower time to walk a specified distance, reduced activity levels, loss of lean muscle, and muscle weakness. It is not yet known if systemic light exposure may reduce frailty in older prostate cancer patients.

PRIMARY OBJECTIVES:

I. Determine if bright white light (BWL), compared to dim white light (DWL), significantly prevents frailty development in older prostate cancer (PC) patients following prostate anti-androgen therapy initiation.

II. Determine if BWL, compared to DWL, significantly increases functional performance and physical activity levels, yields significant reductions in fatigue, lowers body mass index (BMI), and reduces weakness in older PC patients following prostate anti-androgen therapy initiation.

EXPLORATORY OBJECTIVE:

I. Examine the feasibility of collecting and storing clinically-usable bio-measures for future analysis in patients at baseline and if available at 6 months, including blood samples (inflammatory markers), and salivary swabs (genetics, genomics, cortisol circadian rhythms).

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I (BWL): Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo BWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months.

ARM II (DWL): Patients wear an Actiwatch for 5 days at baseline, 3 months and 6 months. Beginning 1-4 weeks after first anti-androgen therapy, patients undergo DWL treatment using Luminette glasses for 30 minutes every morning for 3-6 months.

Eligibility Criteria:
Inclusion Criteria:

* Prostate cancer (PC) patients who are starting androgen deprivation therapy (ADT), abiraterone, or enzalutamide with plans to continue for at least six months with minimal evidence of disease burden in accordance with current standards of care.
* A life expectancy of 6 months or longer.
* All subjects must have the ability to understand and the willingness to sign a written or electronic informed consent.

Exclusion Criteria:

* Significant pre-existing frailty precluding completion of baseline assessments.
* Other active malignancies
* Previous use of radiation therapy within the year prior to consent.
* Widely metastatic disease.
* Confounding serious medical illnesses which causes frailty.
* Severe sleep disorders.
* Eye diseases which limit the ability of light to be processed.
* Severe psychological impairment.
* Current employment in night shift work.
* Previous use of light therapy to alleviate fatigue or depressive symptoms.
* Secondary cancer diagnosis within the past 5 years.
* Plans to travel across meridians during treatment.
* Uncontrolled illness including ongoing or active infection in disease status patients.
Vibration for Muscle Spasms After Spinal Cord Injury

This study uses closed-loop control of tendon vibration to implement clinically meaningful management of muscle spasms after spinal cord injury (SCI), and to understand the mechanisms responsible for spasm generation change in response to vibration.

The specific aims of this study are listed below:

1a) Evaluate the ergonomics of the wearable device that will be used to record and detect spasms, then to deliver vibration to tendons to dampen spasms.

1. b) Determine the vibration parameters that best reduce spasms in leg muscles paralyzed by spinal cord injury (SCI) in the laboratory using the wearable device.
2. a) Examine the efficacy of tendon vibration in altering muscle spasms by treating spasms as they occur in real world environments using 24-hour electromyographic (EMG) recordings.

Hypothesis 2a: Achilles tendon vibration will dampen spasms acutely, and may alter their distribution Assess excitatory and/or inhibitory mechanisms that underlie spasms, and changes induced with vibration, by recording physiological, clinical, functional and self-reported measures of different aspects of spasticity, and health-related quality of life, before and after conditioning spasms with vibration. These data will provide insight into the site(s), magnitude, and time-course of changes with vibration; and user perspective on the effects of the therapy.

Achilles tendon vibration will dampen spasms by reconfiguring circuits generating 6-13 Hz shared drive to motoneurons.

Eligibility Criteria:
Inclusion Criteria:

* Male and females between ages 18-85 years of age
* SCI ( ≥1 month of injury)
* ASIA A, B,C and D
* SCI above L5
* Able to perform a visible contraction with dorsiflexor and hip flexor muscles (allowing testing of largely impaired patients)
* Able to ambulate a few steps with or without an assistive device.

Inclusion criteria for healthy controls:

* Male and females between ages 18-85 years
* Able to complete precision grips with both hands
* Able to complete full elbow flexion-extension with both arms.
* Able to walk and complete lower-limb tests with both legs.

Exclusion Criteria:

* Uncontrolled medical problems including pulmonary, cardiovascular or orthopedic disease,
* Any debilitating disease prior to the SCI that caused exercise intolerance
* Premorbid, ongoing major depression or psychosis, altered cognitive status
* History of head injury or stroke,
* Metal plate in skull
* History of seizures
* Receiving drugs acting primarily on the central nervous system, which lower the seizure threshold such as antipsychotic drugs (chlorpromazine, clozapine) or tricyclic antidepressants.
* Pregnant females, and
* Ongoing cord compression or a syrinx in the spinal cord or who suffer from a spinal cord disease such as spinal stenosis, spina bifida or herniated cervical disk.

This information will be obtained by self-report.
Comprehensive Fall Prevention and Detection in Multiple Sclerosis

The purpose of this study is to examine whether an exercise and educational classroom program can help reduce falls in people with Multiple Sclerosis who fall frequently.

The investigators will recruit 94 people with Multiple Sclerosis, who report having fallen at least twice in the previous 2 months. Participants will be randomized to be placed in either a group that receives classroom training during the study, or into a wait-listed control group that will be offered the classroom training after their participation in the study is completed. All participants will receive mobility and quality of life assessments at baseline, 9 weeks, 5 months, and 8 months. All participants will be asked to record any falls they have on falls calendars.

In addition, 30 participants will be randomized to wear electronic fall detectors on their bodies for the duration of the study. These detectors will record when and where falls occur, and this data will be compared with the participants' self-reported falls as recorded on the falls calendars.

Eligibility Criteria:
Inclusion Criteria:

* Multiple Sclerosis of any type,
* self-reported history of 2 or more falls in the previous 2 months,
* Expanded Disability Status Scale of ≤ 6.0 (i.e. able to walk at least 100 meters with or without a walking aid),
* be willing and intellectually able to understand and to sign an informed consent, and to adhere to protocol requirements,
* have sufficient motor function to complete a written daily record of falls for 8 months,
* be community dwelling.

Exclusion Criteria:

* have a self-reported musculoskeletal or neurological condition other than MS that is known to affect balance or gait and is associated with falls, such as a lower-extremity joint replacement within the past year, peripheral neuropathy, vestibular disorder, alcoholism, stroke, or seizures.
* be unable to follow directions in English,
* have unhealed bone fractures or other condition that may put them at risk of injury during balance training and assessments,
* blind (visual acuity corrected worse than 20/200),
* serious psychiatric or medical conditions that would preclude reliable participation in the study.
A Study of Protein Metabolism, Microbiome and Investigational Probiotic Use in Patients With ALS

ALS, also known as "Lou Gehrig's" disease, is a neurodegenerative disease which is fatal. Treatment for ALS is limited and currently consists of primary symptom relief or support. In addition, time from diagnosis to death averages 3-5 years. New Biotic, LLC has submitted an Orphan Drug Designation Application for an investigational probiotic and have indicated the need for more study of this orphaned drug in ALS patients.

This will be an exploratory protocol of 10 patients and expect to screen approximately 25-30 patients.

The purpose of our study is to examine amino acid levels in plasma pre and post prandial as well as longitudinal gut microbiome in ALS patients taking the investigational probiotic.

1. Purpose: Evaluate the clinical outcomes of muscle strength, clinical global assessments and spasticity in patients taking an Investigational probiotic.
2. Measure changes in questionnaires relating to subjective functional assessments, quality of life, and pain levels over 24 weeks.
3. Describe plasma amino acid levels before and after a protein food challenge in ALS patients of spinal and bulbar type.
4. Evaluate and describe the gut microbiome of patients with ALS.

Design:

This is a non-randomized, open-label, two-group pilot study of plasma amino acid levels, gut microbiome, and of investigational probiotic use in patients with ALS. Participants will be placed into two groups based on certain post-prandial amino acid levels. Patients will be stratified for eligibility based on the results of their amino acid profiles.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of sporadic ALS, definite or probable disease,-revised El Escorial criteria
* Patient must be able to understand the purpose and procedures of the study, sign informed consent and comply with requirements of the protocol.
* Age 18 and older.
* Normal serum Magnesium (1.7 - 2.3 mg/dL) and Manganese (4.7 - 18.3 ng/mL) levels or adequate supplement to obtain normal serum Mg (if Manganese levels are low (\<1.7 mg/dL), Hair Manganese will be evaluated before starting probiotic, and inclusion to the protocol will be at the principal investigators discretion).

Exclusion Criteria:

* Need for consumption of frequent antibiotics, gut pH increasing medications, and/or alkaline water.
* Patient unable to maintain regular follow up or submit to informed consent
* Stool pH \>7.5 - The ideal stool pH for growth and function of the investigational probiotic is 6-6.5.
* Patients who are judged to be ineligible for study entry by investigator or sub-investigator.
68Ga PET/CT Versus 99mTc SPECT/CT for Lung Perfusion and Ventilation Scintigraphy; a Technical and Practical Feasibility Study

Lung perfusion scintigraphy with 99mTc-MAA and ventilation scintigraphy with Technegas (V/Q SPECT/CT) has been the cornerstone for the detection of pulmonary embolisms (PE) for many decades. In last two decades after the introduction of pulmonary CTA, general PE detection has shifted towards CTA and V/Q SPECT/CT has become the modality of choice for specific patient populations (iodine contrast allergy, poor kidney function, pregnancy, etc.) or indications (pre-operative risk stratification, chronic embolism detection, pulmonary hypertension). V/Q SPECT/CT acquisition is performed on a gamma camera, but this technique has distinct challenges and/or disadvantages. A potential alternative is the nowadays broadly available. 68Ga as a positron emitter allows PET/CT imaging. Replacing 99mTc with 68Ga in both MAA and aerosol suspension is easy and requires no modifications. However, 68Ga-V/Q with PET/CT will resolve many of the disadvantages of V/Q SPECT/CT. International studies have proven safety and feasibility of replacing 99mTc with 68Ga and preliminary work by international colleagues and our institute have shown validated preparations of the radiopharmaceuticals. However, in our institution, clinical translation is hampered by lack of data on technical acquisition parameters for our scanners. The aim of this small study is to get more insights into technical parameters for image acquisition, logistical feasibility of V/Q PET/CT, and confirm preliminary non-inferiority of this new technique over the current clinical standard (V/Q SPECT/CT).


Eligibility Criteria:
Inclusion Criteria:

* Adult ≥18 years and declared competent
* Provided written informed consent
* Referred to the Nuclear Medicine Department for a conventional V/Q-SPECT/CT
* Indication for conventional V/Q-SPECT/CT includes known or suspected pulmonary embolism

Exclusion Criteria:

- Pregnancy
Nebulized Hypertonic Saline (3%) Versus Nebulized Adrenaline for Treatment of Bronchiolitis

The primary objective of this study was to compare the effectiveness of nebulized hypertonic saline (3%) and nebulized adrenaline in bronchiolitis. The secondary objective was to assess whether non-responders to initial therapy benefit from continuation of the same therapy.

This trial was conducted at a tertiary care teaching hospital over a period of one year in children with bronchiolitis presenting to the out-patient department and emergency. After obtaining a signed informed consent from the parents, all eligible children were assessed for baseline characteristics. A complete hemogram, chest X-ray were done in all and arterial blood gas analysis where ever required.

Computer generated random numbers were used for enrolment in consecutive manner and patients were randomly assigned into two groups. The first group received one dose (4ml) of nebulized hypertonic saline (3%).The second group received one dose (0.1 mg/kg) of nebulized adrenaline diluted in normal saline to make it a 4ml solution. Supportive care (nasal clearing, antipyretics, oxygenation, intravenous fluids) was done in both groups as necessary.

All children were reassessed 20 minutes after one dose of nebulization using the clinical score and a child was labelled as a "responder" if he showed an improvement in the clinical severity score by atleast 3 points after 20 minutes of nebulization. Both responders and non-responders were given a repeat dose of nebulization according to the group to which the child had been randomized, if: a) Severe audible wheeze with severe respiratory distress (severity score ≥9) b) Inability to maintain saturation \>92% even on an O2 flow of 4 L/min. Non responders were given a maximum of three continuous doses of nebulization.

Child was considered fit for discharge if he/she was feeding well orally, there was no need for intravenous fluids, clinical severity score ≤3 and maintaining oxygen saturation \>92% on room air for a period of more than 12 hours.


Eligibility Criteria:
Inclusion Criteria:

• Children aged 1 month to 2 years with moderate to severe bronchiolitis as per Wang score

Exclusion Criteria:

* Comorbidities such as congenital heart disease, bronchopulmonary dysplasia, cystic fibrosis, neurological diseases
* Known or suspected immunodeficiency
* Congenital malformations
* History of use of steroids within one week prior to presentation
* Severe disease requiring admission to intensive care unit/mechanical ventilation