cyrilzakka/clinical-trials huggingface dataset:
Effect of Beetroot Juice on Blood Pressure Regulation in Post Menopausal Women

In this study the investigators will test the hypothesis that acute consumption of inorganic nitrate (supplied in concentrated beetroot juice) reduces artery stiffness and resting blood pressure, and lessens the rise in blood pressure during handgrip exercise in postmenopausal women. Understanding and improving artery function and blood pressure regulation in women is important because they undergo accelerated arterial stiffening after menopause and have much larger increases in blood pressure when they exercise compared with either premenopausal women or men of similar age.

Postmenopausal women have stiff central arteries and exaggerated blood pressure (BP) responses during exercise compared with either premenopausal women or men of similar age. Arterial stiffness and exaggerated BP responses to exercise are prognostic for heart wall thickening, future hypertension, adverse cardiovascular events, and mortality. Previous studies have reported that acute consumption of nitrate-rich beetroot juice can lower resting and exercising BP responses in older adults. However, these studies included both sexes and did not compare the effects of beetroot juice to a nitrate-depleted placebo (a true control). Thus, the potential BP lowering effects of nitrate supplementation per se have not been established in postmenopausal women. The present study examines the acute (single dose) effects of nitrate-rich beetroot juice on resting hemodynamics (peripheral and central BP, arterial wave properties, etc), and physiological responses to handgrip exercise in metabolically healthy post-menopausal women.

Eligibility Criteria:
Inclusion Criteria:

* Resting systolic blood pressure less than or equal to 160 mmHg
* Resting diastolic blood pressure less than or equal to 100 mmHg

Exclusion Criteria:

* Overt cardiovascular, metabolic, hematologic, pulmonary, renal, musculoskeletal, and/or neurological disease(s)
* Users of any tobacco and/or nicotine products (smokers, chewing tobacco, nicotine-containing patches/gum, smokeless cigarettes)
* Body mass index greater than 35
* Total cholesterol greater than 239 mg/dl
* LDL cholesterol greater than 159 mg/dl
* Fasting blood triglycerides greater than 199 mg/dl
* Fasting blood glucose greater than 109 mg/dl and HbA1c greater than 6.0%
* Individuals currently taking any of the following medications:

  1. blood pressure lowering medication (e.g., beta blockers, ACE inhibitors, angiotensin antagonists, calcium channel blockers, diuretics)
  2. lipid-lowering medication (e.g., statins)
  3. nitrates (e.g. nitroglycerin) for angina
  4. phosphodiesterase inhibitors (e.g., Viagra)
  5. anti-inflammatory drugs
* Individuals currently taking hormone replacement therapy
Screening Study to Identify Pediatric Patients With Hunter Syndrome Who Demonstrate Evidence of Central Nervous System (CNS) Involvement and Who Are Currently Receiving Treatment With Elaprase®

This study is being conducted to identify pediatric patients with Hunter syndrome who have neurodevelopmental disease characteristics, who are currently receiving treatment with Elaprase, and who may be suitable to participate in a clinical study with an investigational agent.


Eligibility Criteria:
Inclusion Criteria:

1. The patient is male and is ≥3 and \<18 years of age
2. The patient is currently receiving weekly IV infusions of Elaprase.
3. The patient, patient's parent(s), or legally authorized guardian(s) has voluntarily signed an Institutional Review Board / Independent Ethics Committee-approved informed consent form after all relevant aspects of the study have been explained and discussed with the patient. The guardians' consent and subject's assent, as relevant, must be obtained.

Exclusion Criteria:

1. The patient has a CNS shunt.
2. The patient has received a hematopoietic stem cell transplant.
3. The patient is currently enrolled in a clinical trial.
4. The patient has a significant medical or psychiatric comorbidity(ies) that might affect study data or confound the integrity of study results.
The Impact of School-Based Intervention for 9-13-year-old School Children with Overweight and Obesity

Childhood obesity is a major issue for the United Arab Emirates (UAE). Interventions modifying people's nutritional behavior and changing their dietary habits can potentially address this problem. This study assessed the effectiveness of the 6-month school-based nutritional educational intervention on fruit and vegetable intake, nutrition knowledge, anthropometric measures, and practice, attitude, and self-efficacy measures.

The problem of childhood obesity is a critical issue for the UAE. Findings of recent studies illustrate that nutritional interventions seeking to modify people's nutritional behavior and change their dietary habits have the potential to address this problem. This article reports the results of the study that was dedicated to the influence of the school-based nutritional educational intervention on fruit and vegetable intake, anthropometric measures, practice, attitude, self-efficacy, and knowledge scores of schoolchildren. The intervention was carried out among 9-13-year-old schoolchildren at public schools from Dubai and Sharjah (n=403). The sample included three groups, including the control group (n=114), Intervention Group 1 (n=148), and Intervention Group 2 (n=141). The control group was exposed to a conventional curriculum on healthy nutrition. Group 1 participated in the intervention involving children, and Group 2 participated in the intervention involving students, peers, and parents.

Eligibility Criteria:
Inclusion Criteria:

* WHO BMI-for-age growth charts, Students with BMI from the 85th to the 95th percentile were categorized as "overweight," and those who were above the 95th percentile were categorized as "obese"
* Attending Government school.
* Within Grades 6-9.
* Live in Dubai or Sharjah
* Female and male students

Exclusion Criteria:

* Students with BMI below the 85th percentile for the WHO BMI-for-age growth charts.
* Not attending a government school
* Living in another emirate (not Dubai or Sharjah)
Physiological and Oral Dental Parameters of Young Child

The aim of this study is to measure some oral and maxillofacial physiological parameters, with a view to creating a modular prototype articulator from young children to adolescents by 3D printing.

In the dental field, the articulators present different interests during the diagnostic and treatments of the dental diseases. Thus they are used to perform dental prostheses, pre-orthodontic analysis or in the context of dysfunction of the manducatory apparatus.

Many children affecting with genetic disease need prosthetic rehabilitation. However, none commercial articulators are adaptable to children. Consequently little dental prosthetic are taken before adolescence, or even adulthood.

The aim of this study is to measure some oral and maxillofacial physiological parameters, with a view to creating a modular prototype articulator from young children to adolescents by 3D printing.

On average, 30 children per week visit the dental department of Reims CHU for dental screening or orthodontic diagnosis. From this cohort, an epidemiological study will be carried out. It will concern different physiological parameters of the face and the oral cavity necessary to make a prototype articulator.

Ideally, the creation of a modular articulator to monitor the growth of a child would remove a number of diagnostic locks, therapeutic and technical.

Eligibility Criteria:
Inclusion Criteria:

First 30 children in each age group (\[3; 6 \[; \[6; 9 \[; \[9; 12\]) presenting to the Odontology Division as part of a first dental care or orthodontic consultation.

Exclusion Criteria:

* Any child consulting to the Odontology Department in emergencies.
* Any child coming out of the weight-of- height growth curve. For example, a child below is considered to have hypo-development. Conversely, a child located above the growth curve is considered to be hyper-developed.
* Any child with absence of at least 2 teeth per quadrant whether it is a genetic etiology (agenesis), infectious (avulsion) or traumatic (expulsion).
* Any child with a maxillofacial malformation generating disorders of the face development (ex: child with a cleft palate ...)
* Any child presenting a Class III of Angle. Indeed the intermaxillary ratios being reversed, a hypo-development of the maxillary is often observed.
* Any child with a cognitive impairment that limits the understanding of the examination undertaken.
* Any non-cooperating child
Cognitive Impairment, Obesity, and the Effects of Bariatric Surgery

Study is designed to screen psychological cognitive baseline and retention/improvement after weight loss surgery.

Patients with morbid obesity have shown to be at increased risk for memory loss and cognitive decline. Obesity and high-fat diets have been associated with deficits in learning, memory, and executive functioning. Bariatric surgery results in significant weight loss for patients and helps resolve obesity-related comorbidities such as diabetes and high blood pressure. Interestingly, bariatric surgery has shown promise in improving some aspects of cognitive function and improved memory. (3-1) Obesity affects brain structure, more specifically the grey and white matter, likely in part by reducing oxygen flow to the various regions in the brain. Studies have shown a correlation between BMI and cerebral blood flow velocity (CBFV), where higher BMI is associated with lower CBFV. Although it is not clear how exactly obesity plays a role in the brain's structural and functional changes, observations revealed compromised grey and white matter integrity, its fiber connectivity or cortical atrophy and metabolic alterations. (2)

Few studies exist on the impact of bariatric surgery on cognition. Some studies have shown that patients with obesity who underwent bariatric surgery had memory and cognitive improvement compared to those who had not undergone surgery. (4) Thus, the investigators hope to add to our understanding of how bariatric surgery can improve cognitive decline and to potentially offer surgery to more patients with baseline cognitive impairment and to improve cognitive function overall for patients with obesity. More longitudinal studies need to be done to connect bariatric surgery effects with cognitive decline, specifically memory.

Eligibility Criteria:
Inclusion Criteria:

* Cognitive impairment/decline, memory impairment/loss, or Alzheimer's disease or dementia and bariatric surgery • Cognitive impairment/decline, memory impairment/loss, or Alzheimer's disease or dementia and obesity, and no bariatric surgery history

Exclusion Criteria:

* Patients without a history of memory impairment/loss, bariatric surgery, or obesity

  * Patients outside of University of California Davis Health System
  * Patients unable to provide consent
Effects of Resistance Training on Physical Activity in Daily Life and Functional Capacity in Hemodialysis Patients

The purpose of this study is to determine whether a supervised resistance exercise training during hemodialysis is effective to increase physical activity in daily life in patients with end stage renal disease.

The patients will be randomized into two groups: intervention and control groups. Patients in the intervention group will receive a supervised resistance exercise training, during hemodialysis, three times/week for 12 weeks, and patients allocate to the control group will received a passive stretching program during the same timeframe.

Eligibility Criteria:
Inclusion Criteria:

* Patients with end stage renal disease on hemodialysis for at least three months
* Sedentary for at least six months

Exclusion Criteria:

* Presence of physical limitations that prevent the implementation of physical tests
* Presence of severe comorbidity and unstable (unstable angina, decompensated heart failure, myocardial infarction history of the past six months, cardiac arrhythmias, uncontrolled hypertension with systolic blood pressure ≥ 200 mmHg and / or diastolic blood pressure ≥ 120 mmHg, diabetes decompensated, severe lung disease, acute systemic infection as well as neurological disorders, musculoskeletal and osteoarticular or other disabling conditions according to the clinical judgment)
* Hospitalization in the three months prior to study entry
The Influence of Having Breakfast on Cognitive Performance and Mood

Breakfast is often labelled the most important meal of the day.

Parents and teachers quite often stress its importance for successful learning during the morning hours. With declining numbers of children and especially adolescents eating breakfast regularly, the study examines the influence of breakfast consumption on cognition and mood of high school students.


Eligibility Criteria:
Inclusion Criteria:

* Healthy high school students

Exclusion Criteria:

* Diabetes
Bioequivalence Study for Benzyl Alcohol Lotion 5%.

To establish the therapeutic equivalence and safety of a generic Benzyl Alcohol Lotion 5% with Ulesfia Lotion 5% in eradication of head lice in the study subjects.


Eligibility Criteria:
Inclusion Criteria:

* Healthy males or non-pregnant females aged 6 month or over with an upper age limit of 60 years.
* Prospective participants upon examination are confirmed to have at least 3 live head lice (defined as lice adults or nymphs) and at least 5 viable appearance louse eggs (nits).
* Prospective participants who give written informed consent or, if the participant is under 17 years of age, whose parent/guardian gives written informed consent to participate in the study.
* Prospective participants who will be available for follow up visits over the 21 days following first treatment.
* Prospective female participants (including female caregivers) of childbearing potential who are willing to provide a urine pregnancy test.
* Prospective participants who agree not to shave their hair or use any other pediculicide, nit combing, or louse treatment method during the course of the study.

Exclusion Criteria:

* Prospective participants with a known sensitivity to any of the ingredients in benzyl alcohol lotion 5% (Hi-Tech Pharmacal Inc) or Ulesfia 5% (Shionogi Inc).
* Prospective participants with a known history of irritation or sensitivity to pediculicides or hair care products.
* Prospective participants with a secondary bacterial infection of the scalp (eg. impetigo/pyoderma) or have a secondary or long term scalp condition that could make it difficult to evaluate the extent and severity of an infestation or that would present a problem in the evaluation of response to therapy (e.g., psoriatic lesions of the scalp, extensive seborrheic dermatitis).
* Prospective participants who have been treated with other head lice products within 4 weeks prior to randomization.
* Prospective participants who regularly shave their hair, have bleached their hair, used a permanent color on their hair, or their hair has been permanently straightened or waved within the previous 2 weeks.
* Prospective participants who have been treated with Trimethoprim containing products within the previous 4 weeks, or who are currently taking such a course.
* Females who are pregnant, planning to become pregnant, during the course of the study period, or are currently breast feeding mothers.
* Females of childbearing potential who are unwilling to use an adequate method of contraception from at least 4 weeks prior to the first application of treatment and until 4 weeks after the last application of treatment, or who are unwilling to take a urine pregnancy test.
* Prospective participants who have participated in another clinical study or used an investigational new drug within 1 month before entry into this study.
* Participants who have already participated in this clinical study.
Frequency of Self-performed Mechanical Control of Plaque

The purpose of this blind randomized clinical trial is to evaluate different frequencies in self-mechanical control of plaque in individuals with historic of periodontitis and in periodic and preventive maintenance in order to assess which frequencies are compatible with maintaining gingival health.

Thirty nine subjects with at most 5% of the sites for GI= 2 (gingival health) will be randomized into three groups with different frequencies in self-mechanical control of plaque: Group 12 hours, 24 hours and 48 hours. The exams of plaque index, gingival index, probing depth, bleeding on probing, clinical attachment level and gingival crevicular fluid will be performed at baseline, 15, 30, 60 and 90 days.

Eligibility Criteria:
Inclusion Criteria:

* Individuals with historic of periodontitis (loss of interproximal insertion ≥3mm in two or more non-adjacent teeth) treated in the Clinic of Postgraduate Periodontics at the Federal University of Santa Maria and included in the periodontal maintenance program;
* Minimum age of 35;
* Individuals with at least 12 teeth in the mouth;
* Maximum of 15% of sites with gingivitis;
* Maximum of 25% of sites with bleeding on probing.

Exclusion Criteria:

* Smokers;
* Pregnant women;
* Individuals with dryness of the mouth (xerostomia);
* Diabetics;
* Psychomotor disturbances;
* Orthodontic equipment;
* Antimicrobial prophylaxis;
* Individuals using any medication associated with gingival overgrowth;
* Individuals that used antibiotic/anti -inflammatory in recent 3 months.
Clinical and Paraclinical Characteristics of the Systemic Scleroderma Cohort According to the Criteria ACR 2013 and the History of Professional Exposure or of Agricultural Environment

The aim of the study is to compare the exposure to environmental and professional toxics by patients with systemic scleroderma and by patients not achieved by this pathology.

This study is based on a questionnaire.

The data will be collected according a retrospective and prospective design :

* at diagnostic of the disease
* at the inclusion in the systemic scleroderma cohort
* during the annual visit (in 2017-2018-2019-2020)

Eligibility Criteria:
Inclusion Criteria:

* Patients with systemic scleroderma

Exclusion Criteria:

-
Effects of Nintendo Switch on Rehabilitation Programs for Elderly People With Cognitive Impairment

Purpose: Healthy aging is the process of optimizing opportunities for health, participation and safety in order to improve quality of life as people age. This study aimed to provide healthy aging for people with cognitive impairment through the use of the Nintendo Switch combined with Occupational Therapy sessions.

Material and methods: a randomized clinical trial was conducted. The sample was randomized using a software program, OxMar, which allowed the separation of the sample into a control group (CG), which received their usual sessions of conventional occupational therapy, and an experimental group (EG), which received therapy with Nintendo Switch, plus their conventional occupational therapy sessions. An 8-week intervention was conducted with Nintendo Switch.

Measures: Nine Hole Peg Test, Box and Block Test, Barthel Index, WHOQOL-BREF, CSQ-8.


Eligibility Criteria:
Inclusion Criteria:

* Adult men or women, aged 65 years or older, cohabitating in the nursing home.
* Not presenting moderate or severe cognitive impairment measured through the MEC- Lobo test (score ≥ 24-35) (20).
* Agree to participate voluntarily, having read the project information sheet and signed the informed consent.

Exclusion Criteria:

* Presence of neurodegenerative pathology.
* Presence of physical pathology that compromised the person's safety.
* Severe cognitive impairment.
A Study to Evaluate the Pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc Fusion Protein for Injection

Primary objective: To assess the pharmacokinetics of Recombinant Human Coagulation Factor VIII-Fc fusion protein for Injection at two dose levels in patients with hemophilia A.

Secondary objectives: To assess Safety and Tolerability by monitoring FVIII recovery and adverse events in patients with hemophilia A.


Eligibility Criteria:
Inclusion Criteria:

* 12 years to 60 years, male.
* The activity of the coagulation factor VIII (FVIII:C) \< 2%, and previously treated with FVIII concentrate (s) for a minimum of 150 exposure days (EDs) prior to study entry.
* Non-immune deficiency (CD4 \> 200/μL).
* Non-acute hemorrhagic state.
* No history of a positive inhibitor test (\< 0.6 BU) or clinical signs of decreased response to FVIII administrations. No Family history of inhibitors.
* Platelet count \> 100,000 platelets/μL.
* Normal prothrombin time or INR \< 1.3.
* Normal thrombin time (TT).
* Normal previous results of vWF antigen examination.
* Negative lupus anticoagulant .
* Capable of understanding and willing to comply with the conditions of the protocol have read (patient and/or guardian).

Exclusion Criteria:

* Hypersensitive to any of the excipients of the test materials (e.g. allergic to murine or hamster origin heterologous proteins).
* History of hypersensitivity or anaphylaxis associated with any FVIII or IgG2 administration.
* Current FVIII inhibitor-positive or history of FVIII inhibitor-positive.
* Other coagulation disorder(s) in addition to hemophilia A.
* Infusion of any products containing FVIII within 4 days prior screening or within 72 h prior to administration.
* Patients with severe heart disease, including myocardial infarction, heart failure (III or higher level).
* Clinically significant of other systematic diseases: alcoholism, drug abuse, mental disorders and mental retardation.
* Significant hepatic or renal impairment (ALT and AST \> 2×ULN; serum bilirubin level \> 3 × upper limit of normal (ULN) , BUN \> 2×ULN, Cr \> 2.0 mg/dL).
* One or more clinically significant tests for Human Immunodeficiency Virus (HIV), Antisyphilitic spirulina (TPHA) and Hepatitis C Virus (HCV) Antibody.
* Patients who received any anticoagulant or antiplatelet therapy within one week prior screening or need to receive an anticoagulant or antiplatelet therapy during the period of clinical trials.
* Patients having major surgery or receiving blood or bood components transfusion within 4 weeks prior screening or having planned major surgery schedule during the study.
* Patients who previously participated in the other clinical trials within 1 month prior screening.
* Any life-threatening disease or condition which, according to the investigator's judgment, could not benefit from the trial participation.
* Patient who is considered by the other investigators not suitable for clinical study.