cyrilzakka/clinical-trials huggingface dataset:
Hydroxychloroquine in Giant Cell Arteritis

Cortico-dependence is frequent in giant cell arteritis patients, and no drugs has proved its ability to prevent corticodependence. Hydrocychloroquine is a well tolerated immunomodulatory drug that may have a corticosteroid sparing potential according to immuno-pharmacological and clinical data. We have designed a multcentric double blind versus placebo randomized controled trial to assess the corticosteroid sparing effect of hydroxychloroquine in non complicated giant cell arteritis.


Eligibility Criteria:
Inclusion Criteria:

* giant celle arteritis with at least 3 ACR criteria including a disgnostic temporal artery biopsy
* corticosteroid treatment since less than 1 month
* age less than 85 years
* signed informed consent

Exclusion Criteria:

* amaurosis fugax, loss of vision, acute lumb ischemia, angina pectoris or myocardium infarctus, mesenteric ischemia or other vascular complications related to GCA
* low life expectancy (\<2 years)
* corticosteroid treatment since more than 30 days whatever the dosage
* primary corticosteroid resistance defined by persistant symptoms despite prednisone for more than 15 days
* previous psychiatric troubles induced corticosteroids
* hydroxychloroquine contra-indicated
Canola Oil Multi-Centre Intervention Trial II

The objectives of the study are to examine the health benefits of dietary canola oils on body composition, specifically on android fat, and weight management. COMIT II will also include analysis of FAEs to elucidate the mechanisms by which canola oil may be modifying body composition. Measurement of endothelial function, inflammatory, adiposity, and insulin sensitivity biomarkers will be done to determine the positive health impact of the changes in body composition achieved through canola oil consumption.

The proposed multi-center clinical trial would engage the same collaborative team that successfully operationalized COMIT I, namely, the Richardson Centre for Functional Foods and Nutraceuticals (RCFFN) at the University of Manitoba (Winnipeg, Manitoba, Canada), the L'Institut Des Nutraceutiques et des Aliments Fonctionnels (INAF) at Laval University (Quebec City, Quebec, Canada), the Department of Nutritional Sciences at The Pennsylvania State University (University Park, Pennsylvania, USA), the Risk Factor Modification Centre at St. Michael's Hospital (Toronto, Ontario, Canada). St. Boniface Hospital Research (Winnipeg, Manitoba, Canada) will be an additional clinical trial site. The proposed COMIT II research program will proceed as a double blind, randomized crossover study consisting of three treatment phases of six weeks, each separated by a 6-week washout period. Participants will consume a fixed composition of a precisely controlled basal, weight-maintaining diet (35% energy from fat, 50% carbohydrate and 15% protein) supplemented with the following treatment oils: (a) regular canola oil, (b) high stability/ high oleic canola oil and (c) a typical "Western diet" fat intake as a control treatment comprised largely of saturated fat with substantial levels of omega-6 linoleic acid, common to current North American intakes. Treatment oils will be isocalorically incorporated into fruit smoothies made with milk and consumed at breakfast and supper. The clinical segment of COMIT II is expected to be completed by the mid to end of the second year, with sample analyses to be completed by the end of year three.

Eligibility Criteria:
Inclusion Criteria:

- Waist circumference ≥94 cm for men and ≥80 cm for women

Participants must meet at least one of the following secondary inclusion criteria:

* Fasting blood glucose of ≥ 5.6 mmol/L
* Triglycerides (TG) ≥1.7 mmol/L
* HDL cholesterol (HDL) \<1 mmol/L (males) or \<1.3 mmol/L (females)
* Blood pressure ≥130 mmHg (systolic) and/or ≥85 mmHg (diastolic).

Exclusion Criteria:

* Kidney, or liver disease, or unstable thyroid disease
* Diabetes mellitus
* Smokers
* Those consuming \>1 alcoholic beverage a day for women and \>2 for men.
* Any participant taking medication known to affect lipid metabolism or endothelial function
Clinical Trial of Jinzhen Oral Liquid in Treating Children With COVID-19 Infection

Jinzhen oral liquid and Jinhuaqinggan Granules were used in the treatment and the control group for 14 days, respectively, to evaluate the effect of Jinzhen oral liquid in treating children with novel coronavirus infection.

To evaluate the effect of Jinzhen oral liquid in treating children with novel coronavirus infection by shortening the time of first negative turn of virus, improving clinical symptoms and shortening hospital stay, and to observe the safety of Jinzhen oral liquid in clinical application.A total of 240 Patients aged 3 to 18 years old or asymptomatic infected persons who meet the diagnostic criteria for novel coronavirus infection in the COVID-19 Diagnosis and Treatment Protocol (Trial Version 9)were planned to be enrolled. Jinzhen oral liquid was used in the treatment group, and Jinhuaqinggan Granules was used in the control group, with 120 patients in each group. The subjects took the medication for 14 days (the medication could be stopped in advance if they reached the discharge criteria), and were followed up for 14 days after discontinuation. During the treatment period, the subjects' vital signs, chest imaging examination, novel coronavirus nucleic acid test, blood routine, urine routine, liver and kidney function, and condition and symptoms should be monitored on the follow-up day specified in the protocol.

Eligibility Criteria:
Inclusion Criteria:

* 1. Meet the diagnostic criteria of novel coronavirus infected patients in COVID-19 Diagnosis and Treatment Protocol (Trial Version 9);

  2. Asymptomatic infection or clinical classification of mild or common type;

  3. Aged from 3 to 18 years;

  4. The informed consent process was in accordance with the regulations, and the legal guardian or the children (≥8 years old) signed the informed consent form.

Exclusion Criteria:

* 1. Meet the severe/critical early warning indicators;

  2. Children who used proprietary Chinese medicine of the same type for more than 3 days before enrollment;

  3. Children with diarrhea.
Low Level Laser Therapy for Treatment of Tinnitus in Red Sea Scuba Divers

Scuba Diving has become a popular hobby, for a leisure activity, diving puts the auditory system at the risk of a wide variety of complaints including tinnitus, Low level laser therapy is a new modality in treatment of tinnitus. This study evaluates effect of laser therapy on tinnitus of Scuba divers in Red Sea.


Eligibility Criteria:
Inclusion Criteria:

- scuba divers

Exclusion Criteria:

* Other ear or neurological diseases
MIGS VS SLT Comparison in Glaucoma Patients

To compare the intraocular pressure (IOP) and number of glaucoma medications lowering of microinvasive glaucoma surgery (MIGS) with the implantation of the trabecular device Hydrus (Ivantis) as a solo procedure and 360° selective laser trabeculoplasty (SLT) to treat primary open angle glaucoma (POAG).

Eligible study patients diagnosed with POAG and not sufficiently controlled by, intolerant of, or non-compliant with their current IOP-lowering regimen. Patients with IOP\>21 mm Hg upon at least two consecutive measurements. Study subjects with typical glaucomatous visual field (VF) loss on Octopus or Humphrey automated perimetry (Carl Zeiss Meditec, Dublin, CA) and glaucomatous alterations to the optic nerve head. Visual field classified as glaucomatous according to the European Glaucoma Society guidelines.

Exclusion criteria : eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids.

Eligibility Criteria:
Inclusion Criteria:

* primary open angle glaucoma diagnosis, intolerant or unresponsive to therapy or not controlled with therapy

Exclusion Criteria:

* eye surgery in the previous 6 months, any previous surgery for glaucoma, evidence of glaucoma of a type other than POAG, and medication with systemic or topical steroids
Determining Rates of Cardiovascular Complications Among Patients of a Managed Diabetes Care Program

The primary objective of this study is to identify whether cardiovascular complication rates are lower in patients who participate in managed diabetes care, in comparison to provincial and national rates. This study will involve an electronic medical record (EMR) chart audit, augmented by a manual review of hospital and other pertinent medical records, as necessary.

The DECIDE study will identify whether cardiovascular complication rates (the composite rate of myocardial infarction (MI), Percutaneous Coronary Intervention (PCI), Coronary Artery Bypass Grafting (CABG), stroke, carotid endarterectomy, peripheral revascularization, and peripheral amputation) are lower in patients who participate in managed diabetes care by ADEC in comparison to provincial and national rates. Comparison statistics will be provided by the Institute of Evaluative Sciences (ICES) Atlas 2003 and other Diabetes studies such as the 2005 DICE study. Complications such as nephropathy and retinopathy will be documented, along with hospitalization rates and all cause mortality. Clinical outcomes relevant to diabetes management such as blood pressure and lipids will also be compared.

Eligibility Criteria:
Inclusion Criteria:

1. Ambulatory patients over the age of 18 years with diabetes mellitus.
2. Current enrolment in ADEC program (\>6 months)or new enrolment in ADEC program (\<6 months).
3. Confirmed diagnosis of diabetes mellitus, according to the current Canadian Diabetes Guidelines.
4. Informed consent provided

Exclusion Criteria:

1. History of only gestational diabetes.
2. Non-GHC member.
3. GHC patients with diabetes who do not attend the ADEC program.
4. Unable to give informed consent.
5. Any conditions/circumstances that prevent the patient from attending ADEC sessions or participating fully in the program.
6. Refusal to allow research staff access to medical records, including hospital charts.
Clinical & Community Approaches to Weight Management

This project seeks to build on innovative strategies to optimize the care of low-income children with a BMI ≥ 85th percentile. To accomplish this goal, investigators will implement a new clinical-community intervention, theoretically grounded in the Integrated Clinical and Community Systems of Care Model, to address obesity through optimized screening and management known to be effective, e-Referrals, Healthy Weight Clinics, and the YMCA's Healthy Weight and Your Child weight management program (originally known as MEND). The study will examine outcomes for children that matter most to a broad group of stakeholders including parents, clinicians, and public health practitioners as well as inform the care of \>7 million children with obesity covered by the Children's Health Insurance Program or Medicaid.

This is a 2-arm RCT. Enrolled patients are randomized to a pediatric weight management intervention (PWMI): 1)a Healthy Weight Clinic based at a federally-qualified health center (FQHC), or 2) a modified Healthy Weight and Your Child intervention delivered in YMCAs. A comparison sample of children receiving care in eight demographically similar FQHCs serve as a comparison group.

Eligibility Criteria:
Inclusion Criteria:

* child is age 6.0 through 12.9 years at referral
* child's BMI meets or exceeds the 85th percentile for age and sex
* parent can read and respond to interviews and questionnaires in English and Spanish

Exclusion Criteria:

* children who do not have at least one parent who is able to follow study procedures for 1 year
* families who plan to leave their primary care health center within the study time frame
* families for whom the primary care clinician thinks the intervention is inappropriate, e.g., emotional or cognitive difficulties
* children who were taking medications that substantially interfere with growth
* children who have a sibling enrolled in the study.
Dose Effect of a Plant Extract on Fatigue

Test the short-term effects of the acute consumption of two separate beverages containing different concentrations of polyphenols, a beverage containing 75 mg of caffeine and a flavored placebo beverage on mental energy and physical performance


Eligibility Criteria:
Inclusion Criteria:

* 18-49 years of age
* Self-report of good health
* Physical activity requirement: Recreationally active (exercise ≥3 times per week for \>30 minutes per session; both cyclists and non-cyclists may enroll)

Exclusion Criteria:

* Under the care of a physician
* Visual impairment that cannot be corrected with glasses or contact lenses
* Inability to perform high intensity exercise (defined perceptually as exercise that feels at least "hard" and this is usually quantified using the Borg 6 to 20 scale. High intensity cycling exercise is defined objectively as exercise causing a high heart rate, defined as a heart rate that is equal to or greater than 70% of heart rate reserve.)
* Inability to adequately perform the cognitive tasks (i.e., cannot complete the task due to -inability to understand instructions or \>50% incorrect responses)
* Presence of current or chronic gastrointestinal, sleep or psychiatric disorder
* Pregnant/lactating
* Current smoker
* Report illegal drug use
* Report hypersensitivity to caffeine
* Food allergies/intolerances/sensitivities (including coffee or related foods/beverages/products)
* Current use of dietary supplements, or prescription medication except for oral contraceptives
* Unwillingness to abstain from over the counter medications (e.g. NSAIDS, allergy medications) and caffeine/coffee/foods high in polyphenols for 12 hours prior to the study
* Unwilling to refrain from consuming apple and grapefruit products on study days and 12 hours prior to test days.
* Participation in another clinical trial within the past 30 days or participation in another PepsiCo trial in the past 6 months
Investigation of Bone Defects and Microcirculation With Computed Tomography and Magnetic Resonance Imaging

Subject of the proposed study is the non-invasive in vivo imaging of bone, bone marrow and localized microcirculation in test animals with osteoporosis, fractures and after placement of bone substitute material with volume computed tomography (VCT) (animals only) and functional magnetic resonance imaging (MRI).

In vivo imaging by means of functional MRI and VCT is carried out in osteoporotic rats, both after the induction of fracture as well as after the placement of bone substitute material.

Furthermore, patients with asymptomatic MM are investigated with functional MR-Imaging (Dynamic Contrast Enhancement- MRI and Intravoxel incoherent motion (IVIM)-imaging) longitudinally to predict the occurrence of osteolysis and the time to progression regarding SLIM-CRAB-Criteria (Rajkumar et al., Lancet Oncology, 2014).

Hypothesis:

1. Affection of microcirculation at the junction of bone and bone substitute material can be displayed by VCT and functional MRI
2. Functional MRI has prognostic value regarding occurrence of osteolysis and progression to MM regarding SLIM-CRAB-Criteria

In an experimental study, rat models were used for imaging studies employing MRI (morphological, DCE- and DWI) and VCT. Mice were not used for imaging purposes due to the small size. Rats were shown to be of optimal size for small imaging studies.

144 patients with (suspected) asymptomatic MM were recruited for dynamic contrast-enhanced MRI (DCE-MRI) and diffusion weighted imaging (DWI) of the vertebral column as well as whole-body MRI using T1tse and STIR images every 6 months until progression and/ or occurrence of first osteolysis.

While during planning and initiation of this prospective trial MM was defined by CRAB-criteria only, in 2014 the SLIM-CRAB-criteria were proposed by the International Myeloma Working Group (Rajkumar et al., Lancet Oncology, 2014) with the goal to treat patients before development of osteolysis or other CRAB-criteria. These criteria were consequently introduced in clinical practice at our institution during the observation period of this study, which affects both inclusion and progression criteria of this study. In order to obtain a conclusive cohort with homogenous inclusion and progression criteria, SLIM-CRAB-criteria where retrospectively applied to restage all patients regarding inclusion and progression to MM defined by SLIM-CRAB-criteria.

Eligibility Criteria:
Inclusion Criteria:

* benign osteoporosis

Exclusion Criteria:

* contra-indications for MRI
Postprandial Nutrient Homeostasis Before and After Weight Loss Induced by Low-calorie Diet or RYGB

The purpose of this study is to compare the metabolic responses to low-carbohydrate and standard-carbohydrate meals in African Americans and non-Hispanic White adults with obesity and the effect of weight loss induced by low-calorie diet (LCD) or Roux-en-Y gastric bypass (RYGB) on the metabolic responses to low-carbohydrate and standard meals. Participants will consume: 1) a standard-carbohydrate meal (\~49 g glucose) and 2) a low-carbohydrate (\~3.4 g glucose) meal on separate study visits performed in a randomized order. We will evaluate the meals' effect before and after \~16-18% weight loss on postprandial i) insulin kinetics, ii) glucose kinetics iii) β-cell function; iv) plasma triglyceride and non-esterified fatty acid concentrations; v) plasma hormone concentrations; vi) plasma cytokine concentrations; vi) plasma metabolomics; and vii) adipose tissue transcriptomics.


Eligibility Criteria:
Inclusion Criteria:

Surgery Group (RYGB):

* Males and Females
* Scheduled for RYGB surgery
* Body Mass Index 35-60 kg/m²
* Without Type 2 Diabetes (T2D)

LCD group:

* Males and Females
* Body Mass Index 35-60 kg/m²
* Without Type 2 Diabetes (T2D)

Exclusion Criteria:

* Regular use of tobacco products
* Previous intestinal resection
* Pregnant or breastfeeding
* Evidence of significant organ system dysfunction or disease other than obesity and T2D
* Use of any medication that might, in the opinion of the investigator, affect metabolic function
* Exercise ≥90 minutes per week
* Use or past use of hormone replacement therapy within the past 6 months
The Effect of Cocoa Flavanol on the BOLD Response and Cognitive Function in Type 1 Diabetes

Type 1 Diabetes (T1D) is associated with microvascular changes in the brain, which can cause cognitive dysfunction. Cocoa flavanols (CF) can stimulate vasodilation, resulting in enhanced cerebral blood flow and better cognitive function. This study aimed to investigate whether acute CF supplementation can improve cognitive function and the hemodynamic (BOLD) response in T1D patients.


Eligibility Criteria:
Inclusion Criteria:

* non-smoking T1D patients or matched healthy controls
* having diabetes for more than 1 year
* males and females older than 18 years
* stable medications for more than 6 months (no use of cholinesterase inhibitors or prior use of multivitamins was allowed)
* adequate visual and auditory acuity to allow neuropsychological testing.

Exclusion Criteria:

* participant enrolled in any investigational drug study within 2 months or longer, depending on the investigational drug half-life
* history in the past 2 years of epileptic seizures or any major psychiatric disorder
* history or MRI evidence of brain damage, including significant trauma, stroke, hydrocephalus, mental retardation, or serious neurological disorder,
* significant history of alcoholism or drug abuse
* unstable cardiac, renal, lung, liver, or other severe chronic disease
* hypertension (systolic blood pressure ≥160 mmHg, diastolic blood pres-sure ≥100 mmHg) or hypotension (systolic blood pressure \<100 mmHg)
* pacemaker or other medical metal devices that precludes performing MRI,
* chronic inflammatory diseases, including lupus, rheumatoid arthritis, or polymyalgia rheumatic
* macrovascular complications
* retinopathy, nephropathy or neuropathy (microvascular complications)
Effects of IMT on Pulmonary Functions IN CASES With Inhalation Injury

The current study aimed to investigate the effect of inspiratory muscle training (IMT) on pulmonary functions (FEV1and FVC), and respiratory muscle strength in patients with inhalation injury, which may prove to be a promising intervention helping to improve exercise tolerance, relieve dyspnea and suggests an improvement in respiratory muscle function.

Forty male patients suffering from inhalation injury were been included in this study, Participants' ages ranged from 20-35 years old. Patients were selected from the burn department, Om El-Masreen hospital, and randomly assigned into two equal groups.

The exercise group received inspiratory muscle training in addition to routine chest physiotherapy in the form of (deep breathing, coughing, and early ambulation) three times per week for four weeks (group A). The Control group received only routine chest physiotherapy (group B). This study obtained ethical approval by the institutional review board of the Faculty of Physical Therapy - Cairo University, with reference number: P.T.REC/012/003431

Eligibility Criteria:
Inclusion criteria:

* Male patients suffering from inhalation injury.
* Participant age ranged from 20-35 years old.
* All patients had the same medical care.
* Participants have received a good explanation of the treatment and measurement device.
* Treatment was conducted one month after inhalation injury.

Exclusion criteria:

Patients were excluded from this study for any of the following cases such as

* Instability of patient's medical condition.
* Presence of any diseases that could affect the study results.
* Participants having respiratory, cardiac, or neurological diseases that affect pulmonary functions.