cyrilzakka/clinical-trials huggingface dataset:
Internet-based Physical Activity Promotion and Exercise Prescription for People With Multiple Sclerosis (Feasibility Study)

This study evaluates the feasibility of a 12-week internet-based exercise and physical activity counseling intervention for people with Multiple Sclerosis (MS).

Due to high inactivity rates in persons with Multiple Sclerosis (pwMS) physical activity promotion for this target group is needed. The internet is an attractive and feasible medium for physical activity promotion, however interventions have to be adapted to the special needs of pwMS. This study aims to evaluate the feasibility of a 12-week internet-based exercise and physical activity counseling intervention.

26 pwMS will be enrolled in the study. All of them receive the intervention. Focus groups and interviews will be conducted with participating pwMS to determine acceptability of the intervention and to explore participants experiences. Compliance with the intervention will be monitored. Additionally, changes in objective physical activity, subjective physical activity, fatigue, walking ability and level of depression will be calculated.

Eligibility Criteria:
Inclusion Criteria:

* diagnosed Multiple Sclerosis (McDonald criteria)
* expanded Disability Status Scale between 0 - 6.5
* neurologically stable (no exacerbation within 30 days prior to enrollment)
* internet access (WiFi)
* basic knowledge on handling personal computer and the internet
* owning a smartphone with the operating system Android or IOS and with access to Google Play Store or Apple App score
* ability to read, write and comprehend as well as communicate electronically
* not regularly physically active (more than 30 minutes twice a week with a moderate intensity (includes aerobic training, resistance training and other sports e.g. Tennis; excludes physiotherapy, physical activity during work or household, grocery shopping, gardening, walking the dog etc.)

Exclusion Criteria:

* clinically relevant cardiovascular diseases
* cortisone therapy in the last 30 days
* cognitive impairment
* severe impairment of hand function (ataxia or paresis impeding the use of a smartphone app or smartwatch)
* severe internal, orthopaedic and metabolic diseases that restrict mobility
Sitagliptin Therapy to Improve Outcomes After Islet Autotransplant

The purpose of the study is to test the effects of sitagliptin on the need for insulin (the hormone that lowers blood sugars) by patients who receive a pancreatectomy and islet autotransplant for chronic pancreatitis.

At the current time, about one-third of patients are insulin independent (do not need to take insulin) after autotransplant, but the other two-thirds still need some insulin. Sitagliptin works by increasing the amount of a hormone called glucagon-like peptide 1, or GLP-1, in the body which then increases the amount of insulin that is made by the beta cells(the insulin producing cell of the islets). GLP-1 might also help protect beta cells from dying under stressful conditions and increase the production of new beta cells.

The primary goal of this study is to see if taking sitagliptin for one year after islet autotransplant increases the number of patients who achieve and maintain insulin independence. Other goals of this study are to see if sitagliptin reduces the amount of insulin injections needed or helps the islets make more insulin.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥18 years
* Scheduled for total pancreatectomy and IAT at UM

Exclusion Criteria:

* Pre-existing diabetes mellitus or hyperglycemia with fasting glucose ≥115 mg/dl
* Medical conditions which, in the opinion of the investigator, might impact islet function (e.g asthma or inflammatory disease requiring chronic systemic corticosteroids)
* Significant renal disease: serum creatinine levels of \>3.0 mg/dL in men and \>2.5 mg/dL in women, or end-stage renal disease requiring hemodialysis or peritoneal dialysis.
* For female subjects, plans to become pregnant or unwillingness to practice birth control for 18 months.
* Islet yield \<1,000 IE/kg body weight (exclusion for treatment with drug/placebo)
Impact of Subcutaneous Electric Lumbar Stimulation on Treatment of Refractory Chronic and Disabling Lumbago

The aim of the study is to show that subcutaneous electric lumbar stimulation reduces pain in chronic lumbago after 12 months of treatment.


Eligibility Criteria:
Inclusion Criteria:

* patients over 18 years old
* Having given their non-opposition
* Affiliated to a national insurance scheme or beneficiary
* Suffering for more than a year from a chronic, invalidating lumbago that is refractory in several lines of treatments

Exclusion Criteria:

* patients with lumbago that can be surgically handled or which justified a medullary stimulation
* having been operated for the rachis for less than 6 months;
* which cannot for cognitive or cultural reasons contribute to the planned evaluations and to the management of the material (remote control);
* for who the investigator can plan that they cannot be followed during one year from the date of the setting-up (non-observance, planned moving, etc.);
* which present psychological, local or general contraindications to the setting-up of a neurostimulation device (Impossibility to stop anticoagulants or aggregation inhibitors, disturb of the hemostasis, cutaneous infection change on the site of setting-up)
* MRI planned within the next year
* pregnant or breast-feeding women.
Omega-3 Fatty Acids and Subconcussive Head Impacts

The purpose of the proposed double-blind, randomized placebo-controlled trial is to understand how supplementation with fish oil \[docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)\] promote brain health against soccer heading. The study involves taking DHA+EPA or placebo, questionnaires, blood draws, brain imaging, tests to evaluate heart function, and soccer headings.

The purpose of the proposed study is to determine whether, and to what extent, supplementation with omega-3 fatty acids \[docosahexaenoic acid (DHA) and eicosapentaenoic acid (EPA)\] can maintain or promote neural wellbeing against repetitive subconcussive head impacts. This study will also characterize what aspects of brain cellular and physiologic resiliencies are enhanced by supplementation in adult soccer players (aged 18-30 years old). A sub-cohort of participants who meet criteria for ADHD diagnosis will be part of exploratory analysises.

Eligibility Criteria:
Inclusion Criteria:

* Between age 18-30
* Current or former soccer player
* At least 5 years of soccer heading experience
* Have internet access
* Willing to commit to avoid any sport activity that purposefully uses one's head to maneuver during the study period (American football, ice-hockey, rugby, wrestling, and soccer heading).

Exclusion Criteria:

* Any head or neck injury within 6 months before the study
* Implanted metal/magnetic devices (e.g., orthodontic braces
* Diagnosed autonomic or cardiovascular diseases (e.g., hypertension)
* Consuming oily fish (2 servings or more/month: salmon, bluefin, swordfish, anchovies)
* Allergy to fish or shellfish
* Consuming omega-3 FA supplements including plant-based (e.g., flaxseed) in the past 3 months.
* Pregnancy
Effect of Biotin on Routine Laboratory Values

Inaccuracy of laboratory medicine diagnostic tests may be associated with ingestion of over-the-counter biotin supplements.

Study group 1) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in over-the-counter supplements (10 mg/d) in healthy adults and subjects with thyroid hormone supplementation. Therefore, this study was designed to assess the association of short-term biotin ingestion for 10 days with performance of various analytes based on Roche, Abbott and Siemens assays.

Study group 2) Due to a lack of systematic studies, little is known about how performance of specific biotinylated immunoassays is associated with biotin ingestion at doses common in multivitamin supplements (biotin = 50 µg/d) in healthy adults. Therefore, this study was designed to assess the association of short-term biotin ingestion for 20 days with performance of various analytes based on Roche, Abbott and Siemens assays.

Eligibility Criteria:
Inclusion Criteria:

* Age above 18 years
* Apparently healthy

Exclusion Criteria:

* Pre-existing condition other than hypothyroidism
* Intake of dietary supplements containing biotin
Paclitaxel Eluting Balloon and Conventional Balloon for In-Stent Restenosis of the Superficial Femoral Artery

The aim of this study is to perform a randomized, controlled trial to compare percutaneous transluminal angioplasty using paclitaxel eluting balloon (PEB) or using a conventional balloon for treatment of superficial femoral artery in-stent restenosis.

The superficial femoral artery is a common place for arteriosclerosis in patients symptomatic for lower extremity vascular disease. Advances in percutaneous transluminal angioplasty (PTA) and stenting have provided new options for the treatment of the disease in this arterial segment. Restenosis after PTA occurs in 40-60% within one year. A novel attempt to reduce restenosis is the use of paclitaxel eluting balloons (PEB). First clinical studies suggest that the use of PEBs during percutaneous treatment of femoropopliteal disease is associated with significant reductions in late lumen loss and target-lesion revascularization. There is no randomized comparison of these treatments in patients with in stent restenosis of the superficial femoral artery. Thus, the aim of this study was to compare the efficacy of PTA with conventional balloon or PEB for in stent restenosis in the SFA in terms of reduction of diameter stenosis at follow-up angiogram.

Eligibility Criteria:
Inclusion Criteria:

* Symptomatic ≥ 70% in-stent restenosis of the AFS, (Rutherford stage 2-6)
* Written, informed consent by the patient or her/his legally-authorized representative for participation in the study

Exclusion Criteria:

* Acute ischemia and/or acute thrombosis of the SFA
* Untreated ipsilateral iliac artery stenosis \>70%
* Not at least one vessel run-off
* Popliteal involvement with stenosis \>70%
* Severe renal insufficiency (GFR \<30 ml/min/m2)
* Malignancies or other comorbid conditions (for example severe liver, renal and pancreatic disease) with life expectancy less than 12 months or that may result in protocol non-compliance.
* Pregnancy (present, suspected or planned) or positive pregnancy test.
* Previous enrollment in this trial.
* Patient's inability to fully cooperate with the study protocol.
Efficacy and Safety of Nitazoxanide 600 mg BID Versus Placebo for the Treatment of Hospitalized Patients With COVID-19

This is a pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.

This is pivotal phase III study to evaluate the efficacy of nitazoxanide 600 mg BID compared to placebo to treat hospitalized patients with non-critical COVID-19.

The aim is to demonstrate a decrease in hospital related complications among patients who are hospitalized with moderate COVID-19 by treating them with nitazoxanide BID 600 mg for 7 days on top of standard care compared to placebo on top of standar care..

Therefore, patients hospitalized with confirmed diagnosis of COVID-19 will be randomized to receive either nitazoxanide 600 mg BID or Placebo.

Eligibility Criteria:
Inclusion Criteria:

1. Informed consent from patient or legal representative.
2. Male or female, aged ≥ 18 years;
3. Laboratory confirmation of 2019-nCoV infection by reverse-transcription polymerase
4. chain reaction (RT-PCR) from any diagnostic sampling source;
5. Hospitalized for up to 48h with signs of respiratory failure with or without non-invasive ventilation and i. Oxygen saturation \<98%;

7. Negative result for pregnancy test (if applicable).

Exclusion Criteria:

1. Participating in another RCT in the past 12 months;
2. Known allergy to nitazoxanide
3. Severely reduced LV function;
4. Severely reduced renal function;
5. Pregnancy or breast feeding;
6. Diagnosis of any other active infection (viral, bacterial, fungal or caused by another pathogen, except the one studied in the trial);
7. History of HIV 1 and/or 2 (Anti-HIV-1,2) and/or HTLV I and II positive;
8. Ongoing antineoplastic treatment with chemotherapy or radiation therapy;
9. Diagnose of severe autoimmune diseases in immunosuppression;
10. Transplanted patients;
11. Any other clinical condition which, in the opinion of the principal investigator, would not allow safe completion of the protocol and safe administration of the investigational products
Multi-Center Study of New Medications to Treat Vaginal Infections

The purpose of this study is to evaluate the safety and efficacy of terconazole gel in the treatment of vaginal infections


Eligibility Criteria:
Inclusion Criteria:

* A clinical diagnosis of vaginal infection that is confirmed by laboratory testing and:
* Capable of providing written informed consent or assent
* Currently not menstruating and not anticipating menses during treatment
* If heterosexually active, subject must be post-menopausal for ≥ 1 year, surgically sterile, or practicing an acceptable form of birth control
* Negative pregnancy test
* Other criteria as identified in the protocol

Exclusion Criteria:

* Other infectious causes of vulvovaginitis
* Subject has recently used, or is expected to require the concomitant use of prohibited medications/products
* Nursing mother
* Use of any investigational drug within 30 days of enrollment
* History of hypersensitivity to any ingredient/component of the formulations
* Other criteria as identified in the protocol
Effect of Intravenous Magnesium During Robot Assisted Prostatectomy

The primary purpose of this study is to investigate the effect of intravenous magnesium on blood pressure after Trendelenburg position during robot assisted prostatectomy.

The secondary purpose of this study is to investigate the effect of intravenous magnesium on pain after robot assisted prostatectomy.


Eligibility Criteria:
Inclusion Criteria:

* Robot assisted prostatectomy

Exclusion Criteria:

* Allergy to magnesium
* Chronic pain
* Chronic opioid use
* Chronic NSAID use
* Renal dysfunction
* Liver dysfunction
* Cardiac arrythmia
* Seizure
Strategy Based Technique to Enhance Memory (STEM) for Improving New Learning and Memory (NLM) in Moderate to Severe TBI

The purpose of this research study is to investigate the effectiveness of a memory enhancement technique in persons with a Traumatic Brian Injury (TBI). The study is designed to research how well this technique can help people with TBI improve their memory and their ability to function better in everyday life

Impairments in higher level cognitive processing, such as new learning and memory, are common in Traumatic Brain Injury (TBI)and negatively impact multiple aspects of everyday life, including occupational and social functioning. Despite this, few studies have attempted to remediate these cognitive deficits in order to improve everyday functioning. While not applied in traditional rehabilitation protocols as of yet, many techniques from cognitive psychology significantly improve learning and memory in healthy persons. These techniques include the generation effect (GE), the spacing effect (SE), and the testing effect (TE). These techniques have recently been incorporated into an 8-session treatment protocol, Stylistic Memory Enhancement (SME), designed to teach participants about each of the techniques, train them on how to apply the techniques in daily life and practice their application to daily life memory demanding situations. The protocol includes teaching participants how to restructure a memory demanding situation in order to make optimal use of self-generation, spaced learning and self-testing.

Eligibility Criteria:
Inclusion Criteria:

In order to participate in this study I must meet the following requirements:

* I am between the ages of 18-65.
* I have had a traumatic brain injury (TBI) at least 1 year ago.
* I can read and speak English fluently.
* I have difficulties with learning and memory skills.

Exclusion Criteria:

* I have had a prior stroke or neurological injury/disease other than TBI.
* I have a history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Bipolar Disorder I or II.
* I have a significant alcohol or drug abuse history (inpatient Treatment).
* I am taking certain medications that might exclude me from the research. The study team will review my medications with me.
Glucose Homeostasis Pre and Post Bariatric Surgery

The investigators wish to study the effects of three forms of bariatric surgery: Roux-en-Y gastric bypass, Sleeve Gastrectomy, and Gastric Banding. The surgery is not part of the clinical trial. If your insurance does not cover the procedure, then you are responsible for payment of the surgical process. We are doing pre and post surgery testing to provide a better understanding of the effect of bariatric surgery-induced weight loss on metabolic function.

Bariatric surgery is the most effective weight loss therapy for obesity. Moreover, the early improvement in insulin sensitivity and the resolution of type 2 diabetes after bariatric surgery has led to the hypothesis that bariatric surgery has specific beneficial effects on glucose homeostasis beyond weight loss alone. However, this hypothesis has never been adequately evaluated in human subjects. Therefore, the primary goal of this proposal is to provide a better understanding of the effect of bariatric surgery-induced weight loss on insulin action and pancreatic beta cell function.

Eligibility Criteria:
Inclusion Criteria:

* BMI ≥ 35 kg/m²
* on stable dose of medications for at least 4 weeks before the pre-surgery metabolic studies

Exclusion Criteria:

* smokes \> 7 cigarettes per day
* previous malabsorptive or restrictive intestinal surgery
* pregnant or breastfeeding
* recent history of neoplasia (\< 5 years ago)
* have malabsorptive syndromes and inflammatory intestinal disease
* diabetes mellitus
* show signs of oral disease or xerostomia (i.e., dry mouth)
* history of chronic rhinitis
* on medication that might affect metabolism
* severe organ dysfunction
The Effect of Different Diets on Arterial Stiffness in Obese Patients on Semaglutide

In patients initiating Semaglutide for weight management, the objective is to compare the effect of the Mediterranean diet and the high protein/low carbohydrate (HP/LC) diet CV parameters, namely arterial stiffness, measured by carotid-femoral pulse wave velocity (cfPWV), and visceral adipose tissue, in addition to other metabolic indicators.

This is a 6-month open label pilot RCT that will be conducted on Lebanese subjects with obesity, upon the initiation of Semaglutide for medical weight management, as recommended by their physician. Patients will be randomized to 2 treatment arms: Med diet and HP/LC diet. Med diet will be hypocaloric, allowing the same energy restriction, of 500 Kcal/d, while the HP/LC diet will be ad libitum. Participants will be recruited from the Endocrine clinics at AUB-MC, and from satellite clinic next in Beirut. Brochures and posters of the trial will be available in the clinic waiting areas. Patients of both participating and non-participating physicians will be recruited in the study.

Eligibility Criteria:
Inclusion Criteria:

* Men and premenopausal women, 18-49 years, with obesity defined as BMI ≥ 30 kg/m2
* Upon the initiation of Semaglutide (within the first 1-4 weeks) for medical weight management, for clinical purposes, as advised by the primary physician
* Able to commit for a 6-month trial visits

Exclusion Criteria:

* Pregnant women
* Patients who are taking or have taken other weight reducing drug therapies in the previous 6 months
* Patients who have undergone metabolic weight loss surgery
* Patients known to have diabetes (HbA1c ≥6.5% at screening)
* Patients with uncontrolled hypertension
* Patients with uncontrolled cardiac disease, pulmonary, renal or liver diseases, active cancer or psychiatric diseases
* Patients with excessive alcohol intake, defined as ≥ 2 glasses per day
* Patients known to have uncontrolled/ untreated thyroid disorders.
* Patients with cushing disease or polycystic ovaries, and those with neuro-endocrine or drug induced obesity (such as anti-psychotic, steroids, hormonal therapy): Such patients are resistant to weight loss, and they need treatment of their primary disease and/or cessation of the culprit medication to lose weight
* Patients with untreated gout
* Patients who have undergone bariatric surgery
Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children

Effects on Ocular Parameters of Myopic Eyes After Orthokeratology in Myopic Children

1.The primary objective of the current study is to investigate changes in uncorrected visual acuity, diopter, accommodation, peripheral refraction, IOP, tear film quality, corneal thickness, corneal topography, corneal biomechanical parameters, objective optical quality, corneal and conjunctiva sensitivity and choroidal thickness for children with different diopters after wearing orthokeratology lenses; 2. Through measure long-term changes of these parameters, including corneal topography, axial length, peripheral refraction, objective optical quality and choroidal thickness, to explore occurrence and development regularity of myopia.

Eligibility Criteria:
Inclusion Criteria:

* 1. subjects were 6-16 years of age; 2.had no other ocular diseases aside from refractive error and no keratoconus (confirmed by pre-treatment corneal topography); 3. had an intraocular pressure (IOP) of \<21 mmHg; 4. had an with-the- rule astigmatism (axes 180 ± 30) ≤ 1.50 D; 5.had a best corrected visual acuity（BCVA） ≤0.00 log MAR units in both eyes (Snellen equivalent to 20/20);

Exclusion Criteria:

* 1. had binocular vision problems; 2.use medications that might affect refractive development; 3.had history of ortho-k or contact lens wear; 4. Ocular surface diseases and other eye diseases which can cause abnormalities of ocular surface; 5. Patients with histories of ocular injury or surgery; 6. Corneal staining and decentration of lens after wearing Ortho-k.
Randomized Clinical Trial of Occlusal Sealant

This study assessed long-term impact of tooth Eruption Stages (ES) on sealant retention on occlusal surfaces previously coated with intermediary bonding layer and it determined caries incidence outcome evolved. The treatment were (sealant/technique): Fluroshield; Helioseal Clear Chroma; Single Bond and Fluroshield; Excite and Helioseal Clear Chroma.

The greatest risk of sealant failure occurs soon after tooth eruption, when contamination with saliva and gingival fluid is almost inevitable. The use of an intermediate bonding layer between humidity contaminated enamel and sealant can improve bond strength, reduces microleakage, and enhances resin flow into fissures. The benefit of primer and adhesive layer beneath the sealant seems to be based on a combination of moisture-chasing effects of the hydrophilic primer, increased flow dispersion imparted by the less viscous primer and adhesive and increased flexibility of the combined and polymerized primer/adhesive/resin complex once reaction is complete.

Eligibility Criteria:
Inclusion Criteria:

* Four caries-free erupted first molar permanent teeth; no systemic diseases and no dental material allergies.

Exclusion Criteria:

* Carious or absence first molar permanent teeth.