cyrilzakka/clinical-trials huggingface dataset:
Effect of Pterostilbene on Cholesterol, Blood Pressure and Oxidative Stress

Pterostilbene is one of several stilbenes found in certain berries, particularly blueberries, that have demonstrated pre-clinical benefit to cholesterol, blood pressure, and oxidative stress. The purpose of this study is to evaluate whether pterostilbene will help control cholesterol and blood pressure, as well as improve markers for oxidative stress in patients with dyslipidemia meeting inclusion criteria. The investigators also want to look at the safety of pterostilbene in these patients.

Subjects will be divided into one of four groups: (1) pterostilbene 50 mg twice daily; (2) pterostilbene 125 mg twice daily; (3) pterostilbene 50 mg/grape extract 100 mg twice daily; (4) matching placebo twice daily taken either one hour before or two hours after a meal. Blood and urine will be collected at enrollment and final study visits. If the patient's low density lipoprotein-C (LDL-C) or total cholesterol (TC) is not within the inclusion criteria based on enrollment blood drawn, the patient will not be allowed to initiate study medication. All study visits will consist of brief clinical examination (including vital signs), subjective adverse event reporting, and fasting donated blood and urine for clinical laboratory tests. Pill counts will be done to assess compliance.

Eligibility Criteria:
Inclusion Criteria:

* Patients ≥18 years of age with a previous TC ≥200 mg/dL and/or a LDL ≥100 mg/dL on either no therapy or stable therapy
* Any concomitant cholesterol medication (not listed in the exclusion criteria) must be at a stable dose for at least 2 months prior to baseline laboratory

Exclusion Criteria:

* Patients with significant hepatic, renal or gastrointestinal tract disease
* Receiving thiazolidinediones or fibric acid derivatives
* Current overt cardiovascular disease
* Women of reproductive potential not receiving birth control
* Pregnant/nursing women
Metabolic Syndrome in Childhood Cancer Survivors

RATIONALE: Gathering information about how often metabolic syndrome occurs in young survivors of childhood cancer may help doctors learn more about the disease.

PURPOSE: This clinical trial is studying metabolic syndrome in survivors of childhood cancer and in their healthy sisters and brothers.

OBJECTIVES:

Primary

* Determine the manifestations of metabolic syndrome (MS) in children and adolescents who are survivors of childhood cancer (CCS).
* Compare the prevalence of MS in CCS to that of matched healthy siblings of similar age and gender.
* Evaluate insulin resistance (as measured by the euglycemic insulin clamp) in CCS and compare to that of healthy siblings of similar age and gender.
* Assess the extent to which prevalent obesity and insulin resistance are correlated with other factors that have been identified in the causal pathway associated with the development of the MS that may be altered in the CCS ( e.g., growth-hormone secretion, adipokines \[adiponectin, leptin\], inflammatory mediators \[e.g., interleukin-6\], tumor necrosis factor-α, and C-reactive protein).
* Obtain dietary and physical activity assessments of CCS and healthy siblings.

Secondary

* Explore demographic (age at treatment, sex-specific differences) and treatment-related factors (exposures and dose-related associations with chemotherapeutic agents, radiation, steroids) as potential correlates with insulin resistance, vascular function, and MS in CCS.

OUTLINE: Patients undergo a comprehensive medical examination including current and past medical history, family history, review of prescription medications, a physical examination including a body and visceral-fat assessment, and anthropometric (DEXA and bone-age x-ray) and blood pressure measurement. Blood samples are collected to measure growth hormone, adipokines (adiponectin, leptin), cytokines (IL-6 and CRP), fasting insulin, fasting glucose, lipids, oxidized LDL, hypothalami-pituitary-gonadal function (estrogen, FSH, LH, testosterone), and thyroid function (free T4 and TSH). Patients also complete questionnaires on dietary intake and physical activity.

Healthy siblings undergo a complete medical examination as patients do, including blood samples collection and questionnaire administration.

Eligibility Criteria:
Inclusion Criteria:

* Subjects must be survivors of childhood cancer, treated at Fairview-University Medical Center or Children's Hospitals and Clinics of Minneapolis and St Paul or siblings of survivors.
* Subjects will be 9-17 years old at the time of their visit.
* Subjects who are cancer survivors must have survived childhood cancer for a minimum of 5 years and be in remission.

Exclusion Criteria:

* Eligibility will not be restricted by race or sex.
* Any women currently pregnant will not be eligible, but may participate 3 or more months after the end of her pregnancy if the study is still ongoing.
* Subjects who underwent hematopoietic cell transplant (HCT) are not eligible for this study.
Pilot Study for Patient-cooperative Control Strategies for Actuated Transfemoral Prostheses

This pilot study investigates the feasibility of novel control strategies for actuated transfemoral prostheses. Several parameters from gait analysis (including motion-capture and ground reaction force measurements) are analyzed. The subjective perception of prosthetic functionality is captured with a questionnaire.

Setting of the study: Conventional prostheses for transfemoral amputees are mostly simple mechanic joints, or have micro-processor-controlled damping. The prototype tested in this study is equipped with a motor that can actively move the knee joint. Therefore, movements like, for example, alternating stair climbing, are possible that cannot be realized with pure mechanical and actively damped prostheses. During level-ground walking, it is hypothesized that less compensatory movements are needed. We have developed an actuated prototypical prosthesis and new control strategies which should facilitate both level-ground walking and stair climbing. Parts of the control strategies have been tested in able-bodied subjects \[1\]. This control strategy has been extended such that only biological stiffness modulation can be rendered \[2\].

Hypothesis: Subjects can use our transfemoral prosthesis to walk on level-ground, to climb several steps and to overcome small obstacles without prior training. The user-cooperative control is intuitive and easily learnable.

Objective of the study: This pilot study is meant to investigate the general feasibility of novel control strategies for actuated transfemoral prostheses. Parameters of a standard gait analysis, like ground reaction forces and kinematics (using a motion capture system), will be recorded. From this data, gait symmetry, step length, walking speed, and other measures can be calculated. The subjective impression of the user will be evaluated with a questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years old
* Written consent of participant
* For amputees: regular use of a transfemoral prosthesis
* For amputees: transfemoral amputation

Exclusion Criteria:

* Bodymass \> 100 kg
* For amputees: mobility class 1
* For amputees: no stable residual leg volume
* For amputees: constrictive contractures
Metacognitive Self Control and Job Interview Training

The study is a randomized controlled trial (RCT) that assesses the effectiveness of a metacognitive self-control training intervention (MCT) in conjunction with virtual-reality job interview training (VR-JIT) in a sample of formerly incarcerated individuals. The study also includes an implementation evaluation.

The goal is to conduct a randomized controlled trial (RCT) that assesses the effectiveness of a metacognitive self-control training intervention (MCT) in conjunction with virtual-reality job interview training (VR-JIT) in a sample of formerly incarcerated individuals, as well as complete an implementation evaluation. Participants will be recruited who who: 1) have previously been incarcerated (e.g., jail, prison), 2) have reentered society, 3) 18 years of age or older, 4) currently are a part of the A Brighter Way program. A Brighter Way is a local re-entry program in Ypsilanti, Michigan (MI) that focuses on helping formerly incarcerated individuals (living in Washtenaw county) build stable and successful lives. Participants will be randomly assigned to conditions where they either receive both MCT and VR-JIT interventions, or where they receive an Active-Control Activity and VR-JIT intervention (with an allocation ratio of 1:1). To assess the effectiveness of MCT, researchers plan to compare behavioral and self-report measures of self-control pre and post interventions, as well as assess employment and recidivism outcomes.

Eligibility Criteria:
Inclusion Criteria:

* 18 years or older
* Actively enrolled in A Brighter Way Program
* 3rd grade reading level or higher

Exclusion Criteria:

* Has uncorrected hearing or visual problem that prevents them from using the training
Study of the Aorta Adaptations to Exercise in Triathletes During Sports Season (CoATri)

Regular sustained physical activity creates a cardiac remodelling : it is athlete's heart. In our preliminary work published in 2016, the investigators demonstrated in a small population of triathletes that there is also a vascular remodelling named athlete's artery. Moreover, the investigators know that left ventricle and aorta behave together like a couple. So they want to study by Cardiovascular Magnetic Resonance Imaging the impact of triathlon on the cardiac AND aortic remodelling.


Eligibility Criteria:
Inclusion Criteria:

* to be enrolled in a social security plan.
* to have a BMI between 18,5 and 25 kg/m²
* to have received full information on the organization of the research and having signed its informed consent
* to have carried out a clinical screening adapted to the research

  \*\*\* Triathlete group:
* to have a minimum performance level: between 2h and 2h45 on an M triathlon during the past year (provide proof),
* to participate in 2018 in a long distance triathlon, i. e. at least distance L
* to have a defined training volume: less than 8 hours per week during the winter months and between 10 and 15 hours per week in preparation of the objective

  \*\*\*Control group:
* to have no more than 150 minutes of moderate physical activity per week (footing, brisk walking, cycling, etc.).

Exclusion Criteria:

* Persons referred to in Articles L. 1121-5 to L. 1121-8 and L1122-2 of the Public Health Code
* Cardiovascular history including Ii.e. known heart rhythm disorders
* Chronic disease: diabetes, high blood pressure...
* Long-term drug therapies that may modify cardiovascular remodeling such as Conversion Enzyme Inhibitor, Angiotensin II Receptor Antagonist,
* Active smoking, even if occasional
* Contraindication to MRI
Clinical Study on a New Flowable Composite as a Restorative in Adult Teeth

Study hypothesis: a new, low polymerization stress flowable composite performs no differently to a conventional, highly filled composite filling material when used as a restorative in small cavities in back teeth.

Study will evaluate the clinical performance of a low shrinking flowable composite filling material, compared with a conventional, highly filled composite restorative when used to permanently fill small cavities in molar and premolar teeth in adult patients.

The study will evaluate clinical performance of a low shrink flowable composite filling material and compare it with a conventional, highly filled composite. The study materials will be used to restore small cavities in molar and premolar teeth in adult patients.

Eligibility Criteria:
Inclusion Criteria:

* 19 years or older
* must give written consent
* be in good general health
* be available for required follow-up visits
* have at least 28 teeth

Exclusion Criteria:

* has rampant, uncontrolled caries
* has advanced, untreated periodontal disease
* heavy use of smoking tobacco (2 packs or equivalent a day)or chewing tobacco
* has systemic or local disorders that contra-indicate the dental procedures needed in this study
* has evidence of xerostomia
* has evidence of severe bruxing or clenching, or in need of Temporomandibular Joint (TMJ) related therapy
* is pregnant at time of screening or tooth restoration
* has known sensitivity to acrylates or related materials
Circulating and Molecular Markers Involved in the Processes of Cachexia, Anorexia and Sarcopenia in Patients With NSCLC

The study aim to evaluate whether some substances produced by muscle or adipose tissue may play a role in the course of the disease by interfering with the effectiveness of therapies.

The study is aimed at patients with NSCLC in whom plasma levels of particular biomarkers will be studied before and after treatment with chemotherapy and immunotherapy or immunotherapy alone.

In particular, the plasma levels of GDF15, FGF21, HN, Activin molecules and microRNAs involved in inflammatory processes, called inflammamiR, in particular of microRNA146, 126, 21, 188, 155, will be studied.

Assessments of cellular markers of leukocyte aging will also be performed (determination of telomere length is a widely used measure of biological aging)

Eligibility Criteria:
Inclusion Criteria:

* Patients with NSCLC in advanced stage (IIIB, IV)
* Patients eligible for the treatment with single-agent immunotherapy (Pembrolizumab), or a chemo-immunotherapy combination among the approved ones for I line
* Obtainment of the informations related to medical history and the possibility to have an adequate follow up
* Obtainment of the informed consent
* Age ≥ 18 years

Exclusion Criteria:

* Patients with psychiatric alterations, neurological diseases or other condistions that could not allow adhesion to study protocol and the obtainment of the ICF
Study to Evaluate the Safety and Efficacy of DR-3001 Versus Placebo in Women With Overactive Bladder

This is a placebo-controlled, double-blind study to evaluate the safety and efficacy of two doses of DR-3001 in women with overactive bladder who have symptoms of predominant or pure urge incontinence, urinary urgency and elevated urinary frequency

This is a multi-center, randomized, placebo-controlled study to compare two doses of DR-3001 to placebo for a 12-week treatment period. The overall duration of patient participation will be for approximately 19 weeks. Patients will be required to keep a daily diary record of study medication use and incontinence episodes

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of overactive bladder and incontinence for at least 6 months
* Using birth control or menopausal
* Willing to discontinue current medication for overactive bladder

Exclusion Criteria:

* Pregnant or given birth in the last 6 months
* Three or more urinary tract infections a year
* Uncontrolled glaucoma, hypertension, diabetes or myasthenia gravis
* History of bladder cancer, ulcerative colitis or severe constipation
* Any contraindication to vaginal delivery systems
Performance Of Class I Composite Restorations After Cavity Finishing By Air Abrasion Versus Diamond Stone

The aim of the study is to reveal the performance of the resin composite restorations after finishing the cavity walls and margins using bioactive glass air abrasion particles in comparison to the routine finishing with the finishing diamond stone according to the FDI criteria for post operative sensitivity, marginal adaptation, marginal discoloration, secondary caries, and retention.

Intraoral air abrasion is the process of altering the surface of the tooth structure through the use of abrasive particles propelled by compressed air or other gasses. The use of intraoral air abrasion has become practical with devices that simultaneously output abrasive particles and water to control the spread of the particles. There are different types of abrasive particles maybe used depending on the clinical application for which the intraoral air abrasion is being performed. Intraoral air abrasion may also be used as a tool for dental prophylaxis, often called air polishing.

Different particles could be incorporated into air abrasion devices according to the intended use of them, such as aluminum oxide (alumina), Calcium Sodium Phosphosilicate (Biactive Glass) and Sodium bicarbonate. To obtain maximum cutting efficiency, the particle should be hard enough to indent the substrate it abrades, and irregular in shape with a sharp cutting edge. Round and smooth particles possess poor abrasive properties, so it may be used for polishing needs "air- polishing". Increased air pressure provided an increased number and velocity of the particles. Abrading power must be proportional to kinetic energy of the particles, which is the function of mass and velocity of the particle. The cutting efficiency of air abrasion depends on several criteria, such as: size, shape, hardness, density of the particles and air pressure.

Aluminum oxide (alumina) are the most abrasive type of particles used. They are irregular in shape with different particle sizes. Intraoral sandblasting with alumina particles (Al2O3) was first described in 1945 by Black. Initially, it was reported that the bond strength to the tooth surface improved, also confirmed by recent investigations, and some authors adopted its use in clinical procedures even after preparing the cavity with rotating instrument. A bioactive glass abrasive, is also commercially available but indicated for the purpose of tooth polishing. Some work has also showed potential for it to have selective cutting properties. However, its cutting time can take 2-3 times longer than alumina, making it clinically indicated for cavity finishing and not cutting.

Eligibility Criteria:
Inclusion Criteria:

* Good oral hygiene (plaque index score 0 or 1).
* Absence of abnormal occlusion habits (e.g. bruxism, nail biting, tooth clenching and mouth breathing).
* Patients approving to participate in the study.

Exclusion Criteria:

* Patients with known allergic or adverse reaction to the tested materials.
* Systematic disease that may affect participation.
* Xerostomic patients.
Effect of Growth Hormone in Children With Growth Hormone Deficiency

This trial is conducted in the United States of America (USA). The purpose of the trial is to compare the effect of Norditropin® using different dosing regimens in children suspected of growth hormone deficiency.


Eligibility Criteria:
Inclusion Criteria:

* Clinically suspected GHD
* Height \< -2.0 SDS
* Serum IGF-I less than or equal to -1.0 SDS
* Bone age less than or equal to 9 years for boys and less than or equal to 7 years for girls.
* Puberty Tanner Stage I

Exclusion Criteria:

* Previous use of growth hormone
* Growth retardation attributable to causes other than GHD (e.g. inborn errors of metabolism, primary bone disease, chromosomal disorders, etc.)
* Intrauterine growth retardation: birth weight \< 3rd percentile.
* Administration of other growth-altering medications.
* Evidence of any malignancy or intracranial tumors.
Treatment for Opiate Addiction: Prognostic fActors of Responsiveness to Maintenance Treatment

A global and integrative treatment of opioid-use disorders (OUD) with opiate maintenance therapy (OMT) and psychosocial interventions is recommended by all current guidelines. Treatment of OUD aim at prevents risks and consequences of opioid use (death by overdose, contamination with infectious diseases, mental and physical degradation, social exclusion and decrease of quality of life). OMT are approved since more than 20 years for OUD and a large number of patients have been treated. Nevertheless, identification of prognosis factors associated with good outcome is still limited. OMT duration, high dosages of OMT and patient good consistency have been identified as good prognosis factors but other individual factors could be involved and explain why OMT isn't as effective for all patients. The investigators assume that social environment, other addictive behaviors, psychiatric comorbidities, personality disorders and pharmacogenetics parameters might be of interest. Association between phenotype/ genotype, safety of OMT and therapeutic outcome will be especially assessed. For voluntary patients specific tools for risk reduction will be implemented (screening of infectious diseases with blood tests and fibrosis with fibroscan). Thus, the aim of TOPAZE study is to highlight prognosis factors for good outcome in the treatment of OUD moderate to severe at 12 months follow-up. Three main axes will be considered: clinical, pharmacological and pharmacogenetics.

All patients with moderate or severe OUD diagnosis (according to Diagnostic and Statistical Manual Diploma in Social Medicine 5) who initiate OMT in addictionology department of Nantes hospital or in addiction care and prevention centers of Nantes could be included. Data will be collected during 3 visits.

During the first visit (inclusion), clinical interview, electrocardiogram, urinary and blood tests (pharmacokinetics and pharmacogenetics analysis) will be provided. Infectious disease screening and fibroscan could be also provided as the patient wishes. Inclusion visit will also correspond to initiation of OMT.

At 6 months follow-up (second visit) clinical interview, electrocardiogram, urinary and blood tests (pharmacokinetics and pharmacogenetics analysis) will be provided.

At 12 months follow-up (final visit) clinical interview, electrocardiogram and urinary test will be provided.

Eligibility Criteria:
Inclusion Criteria:

* Minimum age of 18 years
* Initiation of treatment with OMT (methadone or buprenorphine) for an OUD moderate to severe (according to DSM 5) in Nantes Hospital addictionology department or in an addiction care and prevention centers in Nantes.
* Affiliated to social security
* Consent to participate

Exclusion Criteria:

* Upper cerebral function disorder inconsistent with participating in the study
* Difficulty to understand, read or write French language
* Adult under guardianship or curatorr
* Pregnant woman
Immunogenicity, Reactogenicity of Shingrix in SLE

To investigate the immunogenicity, reactogenicity and safety of 2 doses of the adjuvanted herpes zoster subunit vaccine (Shingrix) in patients with SLE in a randomized trial.


Eligibility Criteria:
Inclusion Criteria:

* Males or females ≥ 19 years of age at time of consent
* ≥4 of the 1997 ACR13 or the 2012 SLICC/ACR criteria for SLE (13, 14)
* Clinically stable SLE
* Corticosteroid use: ≥ 5mg/day of prednisolone equivalent
* Stable dose of one or more of the following immunosuppressive treatment ≥ 4 weeks

  * Antimalarials (≤400 mg/day)
  * Azathioprine (≤3 mg/kg/day)
  * Mycophenolate mofetil (≤3 mg/day)
  * Tacrolimus (≤5mg/day)
  * Methotrexate (≤20mg/week)
  * Cyclosphosphamide (≤1mg/BSA/month)
* Must understand and voluntarily sign an informed consent form including writing consent for data protection

Exclusion Criteria:

* Pregnant or lactating females
* Acute infection with T \>38°C at the time of vaccination
* Previous anaphylactic response to vaccine components or to egg
* History of Guillain-Barre syndrome or demyelinating syndromes
* Any condition including laboratory abnormality which places the subject at unacceptable risk
* Subjects who decline to participate