cyrilzakka/clinical-trials huggingface dataset:
The Regulation of Osteoprotegerin by Mechanical Stimulation

To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. In situ hybridization and immunohistochemistry analysis for OPG and RANKL will reveal their roles in this physiological process.

Long treatment time is a major factor causing high fee for orthodontic treatment. Patients would have dental caries or periodontitis resulted from improper oral hygiene care during this long treatment period. Therefore, how to speed up the tooth movement which determines the duration of orthodontic treatment, can help more people to obtain good occlusion and esthetics. Orthodontic force on tooth induces bone resorption on the compression side and bone deposition on the tension side, thus bone remodels and then tooth moves. Bone resorption is a complex process. Osteoblasts play an important role during initiation of bone resorption.

Changes OPG expression of osteoblasts under mechanical stimulation can play a role in bone remodeling. In order to test this hypothesis, the following specific aims will be achieved:

1. To test whether levels of OPG can be changed during orthodontic treatment. Alveolar bone samples will be collected from partially impacted third molars after orthodontic uprighting for different period of time in volunteers. In situ hybridization and immunohistochemistry analysis for OPG and RANKL will reveal their roles in this physiological process.
2. To optimize the regulation by changing magnitude and frequency of pressure, and characterize the time table for these changes..

Eligibility Criteria:
Inclusion Criteria:

* patients with two mandibular impaction third molars containing at least one mesially angular impaction with crown exposed to the oral cavity

Exclusion Criteria:

* pregnancy or diseases with abnormal bone metabolism
Relaxation Response Training to Treat Hypertension

Interventions such as Relaxation Response appear to have widespread effects on physiology. Endothelial function, changes in genomic expression, several biomarkers have been associated with chronic stress and cardiovascular dysfunction, and there is some suggestion that elicitation of the Relaxation Response may lead to improvement in-or normalization of-these factors. By studying the impact of the Relaxation Response on endothelial function, genomic expression and biomarkers among subjects with hypertension, it may be possible to better understand the biologic underpinnings of Relaxation Response-type interventions. Furthermore, with a greater understanding of the physiologic mechanisms by which the Relaxation Response works, it may be possible to better target other symptoms and conditions that can be effectively treated by such an intervention.


Eligibility Criteria:
General Inclusion Criteria:

* Healthy men and women
* Hypertension (stage 1)
* 18-70 years old

General Exclusion Criteria

* No asthma or nasal allergies
* Non-smokers
* If on anti-hypertensive medication willing to discontinue
* Cannot currently practice Tai Chi, meditation, or yoga regularly
* Current use of the following medications: phosphodiesterase type 5 inhibitors, long-acting nitrates, systemic corticosteroids, anti-inflammatories, immunosuppressive or cytotoxic therapies (currently or within the last 12 months), anabolic steroids, and antidepressants.
PRE-ProstAtectomy MRI-GuidEd Stereotactic Body RadioTherapy for High-Risk Prostate Cancer Trial (PREPARE SBRT)

Men with prostate cancer with Gleason Score of 8 or greater or clinical/radiographic evidence of T3 disease will be considered for this trial.

Patients with a diagnosis of high risk prostate cancer with a Gleason score of 8 or greater are eligible for this trial. The study will enroll 20 subjects in 3 years. This is a single arm study and the primary objectives is to assess if a patient can undergo a radical prostatectomy after SBRT without a post-operative grade 3 or higher toxicity (according to Clavien-Dindo Classification) at 30 days. Secondary objectives are to assess acute toxicity and quality of life scores. Exploratory objectives will include analysis of tumor and normal biopsied and resected tissue and serum markers and interpretation of interfraction and intrafraction MRIs.

Eligibility Criteria:
Inclusion Criteria:

* Men aged greater than equal to18 with histologically confirmed primary prostate cancer.
* KPS greater than equal to 70
* Patient with a negative staging bone scan.
* Patient can undergo an MRI.
* Patient with negative staging CT or MRI of pelvis. Suspicious evidence of nodal involvement on staging CT or MRI of pelvis is defined as greater than 1 cm on short axis. Documented negative biopsy of suspicious node required.
* Patient is medically fit to undergo prostatectomy.
* Patient has either Gleason Score greater than equal to 8 on biopsy and/or clinical/radiographic evidence of T3 disease.

Exclusion Criteria:

* Prior history of receiving pelvic radiotherapy.
* Patient is unwilling to undergo prostatectomy.
* Patient with active inflammatory bowel disease defined as currently receiving therapy for IBD.
Optical Coherence Tomography in Multiple Sclerosis Patients

To evaluate the ability of different spectral domain optical coherence tomography (OCT) devices, as well as different acquisition and analysis packages, to detect disease progression in patients with multiple sclerosis with and without a history of optic neuritis

Optical coherence tomography imaging of the retina has been shown to be an effective non invasive method to study retinal changes associated with multiple sclerosis induced optic neuritis. The retina is a unique structure in that it is an unmyelinated part of the central nervous system (CNS). However, it is uncertain which layer of the retina provides the best correlation with MS disease. The investigators propose a prospective, case-control study to compare OCT measurements from different parts of the retina of MS patients with optic neuritis, those without optic neuritis, and healthy controls. The investigators will then correlate the OCT measurements to clinical measures of disease. This will allow future studies to use OCT technology as a primary outcome in studying MS axonal and cell body injury of the CNS, as well as evaluating strategies in treating MS.

Eligibility Criteria:
Inclusion criteria (MS with acute optic neuritis group):

* History of unilateral optic neuritis as a manifestation of multiple sclerosis.
* Age between 18 and 65, inclusive.
* Ability to perform adequate OCT exam.
* Able to provide informed consent to participate in study.

Exclusion criteria (MS with acute optic neuritis group):

- Refractive error greater than ±6 diopters.

Inclusion criteria (MS without acute optic neuritis group):

* History of multiple sclerosis without optic neuritis
* Age between 18 and 65, inclusive.
* Ability to perform adequate OCT exam.
* Able to provide informed consent to participate in study.

Exclusion criteria (MS without acute optic neuritis group):

- Refractive error greater than ±6 diopters.

Inclusion criteria (healthy controls):

* Age between 18 and 65, inclusive.
* Ability to perform adequate OCT exam.
* Able to provide informed consent to participate in the study.

Exclusion criteria (healthy controls):

* Prior history of neurological disease.
* First degree relative with MS.
* Refractive error greater than ±6 diopters.
Shear Wave Elastography in Adhesive Capsulitis

This study aimed to evaluate the contribution of sonoelastography in the diagnosis of adhesive capsulitis in patients with a clinical prediagnosis of adhesive capsulitis (AC) and inferior glenohumeral capsuloligamentous complex (IGHCC) involvement demonstrated by magnetic resonance imaging (MRI).

The study will include a total of 30 patients who will be diagnosed with AC based on clinical evaluation by physicians from various clinical departments, including physical medicine and rehabilitation, and orthopedics. The diagnosis will be confirmed by two experienced radiologists specializing in musculoskeletal imaging. Based on clinical evaluation and MRI findings, a control group of 34 individuals without suspected AC will be included. MRI imaging will be performed using a 3 Tesla MRI scanner. Sonoelastography will be performed using a Siemens Acuson-S2000 ultrasound device with a 9L4 (4-9 MHz) linear probe and the Virtual Touch Quantification (VTQ/ARFI) method. Shear wave elastography will be applied to the IGHCC to obtain the mean shear wave velocity (SWV) values. The contribution of sonoelastography in the diagnosis of adhesive capsulitis in patients with a clinical prediagnosis of adhesive capsulitis (AC) and inferior glenohumeral capsuloligamentous complex (IGHCC) involvement will be investigated.

Eligibility Criteria:
Inclusion Criteria:

* Having a preliminary diagnosis of Adhesive Capsulitis in Physical Medicine and Rehabilitation or Orthopedics clinic and the diagnosis confirmed by MRI
* Giving consent to participate

Exclusion Criteria:

* Presence of tumor, arthritis, surgical history, or trauma history in the relevant shoulder joint
* Cervical radiculopathy, a central or peripheral neurological deficit in the upper extremity
* Incomplete sequences or inability to evaluate images due to artifacts in MRI imaging
* Presence of pain and/or limited movement to the extent that it hinders positioning or manipulation for ultrasound examination
* Unwillingness to participate in the study voluntarily
Examining the Efficacy of a Mobile Therapy for Children With Autism Spectrum Disorder

The purpose of this research is to study the effects of a novel artificial intelligence (AI) tool for automatic facial expression recognition that runs on Google Glass through an Android app to deliver social emotion cues to children with autism during social interactions. This novel device will use a camera, microphone, head motion tracker to analyze the behavior of the subject during interactions with other people. The system is designed to give participants non-interruptive social cues in real-time and will record social responses that can later be used to help aid behavioral therapy. It is hypothesized that the system's ability to provide continuous behavioral therapy during social interactions will enable faster gains in social skills.


Eligibility Criteria:
Inclusion Criteria:

1. the child has been diagnosed professionally with ASD
2. the child is currently receiving ABA therapy at least twice per week at home.
3. The child's family is willing to drive to Stanford University for up to 4 study appointments.

Exclusion Criteria:

1. The child scores less than 15 on the Social Communication Questionnaire
2. The child's family does not speak English
Hypokalemia in Hospitalized Patients for Heart Failure in the Therapeutic Cardiac Failure Unit

Hypokalemia is very common in heart failure patients. Deleterious effects have been report on the cardiovascular system. Most of the clinical data concerning this ionic trouble are based on post-hoc study and some findings seemed disjointed.

This study tried to describe hypokalemia impact during hospital stay in hospitalized patients with heart failure and particularly on mortality and re-hospitalization.

Eligibility Criteria:
Inclusion Criteria:

* Hospitalized patient in the Therapeutic Cardiac Failure Unit in the CHR Metz-Thionville
* Patient with congestive heart failure

Exclusion Criteria:

* None
Short Term Safety and Efficacy of Lubiprostone in Adults With Cystic Fibrosis

The purpose of this study is to determine the short term safety and effectiveness of lubiprostone when used for constipation in adults with cystic fibrosis.

Cystic fibrosis (CF) affects about 30,000 people in the United States. It is caused by an absent or dysfunctional protein called CF transmembrane conductance regulator (CFTR) which functions as a chloride channel. Lubiprostone is a medication indicated for constipation that activates type 2 chloride channels (ClC-2) and has the potential to be an effective treatment for constipation in adults with CF. It has the potential to correct the underlying disorder by utilizing a chloride channel whose activity does not depend on CFTR. This project is a prospective open-label pilot study to examine the safety and effectiveness of lubiprostone when used in adults with CF with constipation. The specific aims are as follows: 1) Determine the effectiveness of lubiprostone for constipation in participants with CF, and 2) Determine the short term safety of lubiprostone in adults with CF. Data will also be collected to generate further information about the effect of lubiprostone on nutritional status.

Eligibility Criteria:
Inclusion Criteria:

* Men and women of all races
* 18 years of age or older at time of enrollment
* Diagnosis of cystic fibrosis
* History of constipation, as defined by the Rome III criteria, OR the requirement of chronic scheduled doses of a laxative, OR a score ≥1.5 on the Patient assessment of constipation symptoms (PAC-SYM)15 survey administered during the screening visit, OR a score of less than 3 on the Bristol Stool Scale (BSS) at the screening visit.

Exclusion Criteria:

* Current gastrointestinal (GI) obstruction
* History of GI obstruction requiring hospitalization within six months of enrollment
* Pregnancy or breastfeeding
* Hypersensitivity to lubiprostone or any of its components
* Serum creatinine \>1.8 mg/dL at last annual visit
* Clinically significant liver disease, defined as aspartate aminotransferase (AST) or alanine aminotransferase (ALT) \>3X upper limit of normal
* History of frequent hospital admissions for CF exacerbations (≥4 in the last 6 months)
* Currently registered on a lung transplant waiting list
* Women of capable of child-bearing who either refuse a pregnancy test, or are incapable or unwilling to use contraception during the protocol, or both.
* Any other condition, in the opinion of the investigators, that interferes with the ability of the participant to comply with study requirements, confers significant risk to the participant, or limits the ability of the participant to complete the study
Point-of-Care Echocardiography to Assess Impact of Dynamic Cardiac Function, Renal and Cardiac Biomarkers in Cirrhosis With Hepatorenal Syndrome-Acute Kidney Injury

Point-of-care echocardiography (POC-Echo) is used to determine left ventricular systolic and diastolic dysfunction (LVDD), inferior vena cava (IVC) dynamics and volume status in cirrhosis and Acute-on-chronic liver failure ACLF accurately.

We will assess IVC dynamics, LV systolic function \[LV ejection fraction (EF) \& cardiac output (CO)\], and diastolic dysfunction (E/e', e' and E/A ratio) and urinary biomarkers (cystatin C and NGAL) in patients with cirrhosis and ACLF with hepatorenal syndrome-acute kidney injury (HRS-AKI).


Eligibility Criteria:
Inclusion Criteria:

* Cirrhosis of any Etiology
* Patient with acute kidney injury meeting HRS-AKI criteria

Exclusion Criteria:

* Hepatocellular carcinoma
* Patients with active variceal bleeding
* HIV or severe immunocompromised state
* Chronic kidney disease (CKD) on renal replacement therapy (RRT),
* Previous transjugular intra hepatic portosystemic shunt (TIPS)
* Porto-pulmonary hypertension,
* Coronary artery disease
* Congenital or valvular heart disease
* Prosthetic cardiac valves
Preventing Childhood Obesity Through a Mindfulness-Based Parent Stress Intervention

This study will examine the mediator/moderator variables that affect efficacy of a parent stress intervention with nutrition education (PMH+N: parenting mindfully for health) vs. Control intervention with nutrition education (CTL+N) on parent stress, parenting, health behaviors and child obesity risk. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.

This is a 5-year interdisciplinary project to assess a 12-week Parenting Mindfully for Health (PMH) + nutrition counseling (N) versus contact control intervention (C) + nutrition counseling (N), to examine short-term and long term enduring effects of PMH+N to promote healthy eating and physical activity in parent and child, and prevent childhood obesity risk in 2-5 year olds, via changes in parent stress and parenting. A non-randomized historical control group will also be assessed during the intervention and follow-up periods throughout to obtain outcome assessment without any interventions being provided.

Eligibility Criteria:
Inclusion Criteria:

* Family with a child between 2-5 years
* BMI of parent ≥30kg/m2
* Parents aged 18 yrs or older
* High parent stress (PSS mean score ≥25)
* Low income family as determined by HHS Poverty Guidelines

Exclusion Criteria:

* Diagnosis of mental retardation, autism or other pervasive developmental disorder for child;
* Current serious psychiatric or medical disorder requiring immediate treatment, including active alcohol or substance use disorders (confirmed by urine toxicology screening and history), psychotic illnesses, suicidal ideation, untreated diabetes, cardiovascular disease, cancers or any other active current illnesses that preclude study participation for child or parent;
* Inadequate English proficiency to complete questionnaires.
The Effects of Bright Light Therapy on Adolescent's Sleep Quality and Well-being

Sleep problems are common among adolescents which can have a variety of serious biological, emotional, cognitive and psychological consequences. Numerous studies have shown that adolescents who suffer from insufficient sleep and poor sleep quality experience decreased mental well-being which is a growing concern in modern societies.

Effective interventions that enhance sleep quality among adolescents are lacking. One possible reason for sleep problems among adolescents is disturbance in the body's circadian rhythms. As light is known to be the main coordinating factor in circadian rhythms, light therapy is an auspicious method which aims to entrain the circadian rhythms, thereby enhancing sleep quality and well-being. Indeed, bright light therapy (BLT) has been shown to be a promising treatment to improve sleep and decrease depressive symptoms among different patient groups. However, BLT interventions among healthy adolescents are needed. Therefore, the current study will investigate whether BLT in classrooms of 16 year old students can improve their sleep quality and well-being. The results from the study can be important as it is the first one to examine whether light intensity in the classroom affects sleep and well-being among adolescents. Furthermore, if the hypothesis will be supported, a simple and relatively inexpensive method can be implemented to promote better sleep quality and thus have an extensive effect on adolescents' well-being.

Aim 1 - Assess whether BLT will improve sleep quality of adolescents. Aim 2 - Assess whether BLT will decrease depressive symptoms in adolescents. Aim 3 - Assess whether BLT will improve mood in adolescents.


Eligibility Criteria:
Inclusion Criteria:

* First-year students at the school where the research takes place.
* Participants provide written informed consent.
* Parents or caregivers of participants provide informed consent.
* Read and write Icelandic.

Exclusion Criteria:

* Not first-year students.
* Participant or parent does not provide written informed consent.
* Not capable of reading and writing Icelandic.
Dietary Advanced Glycation End Products and Migraine

Is dietary intake of advanced glycation different between individuals with and without migraine? Is there a difference between the groups in terms of energy and nutrients? The answers to these questions are sought.


Eligibility Criteria:
Inclusion Criteria:

* To be diagnosed with episodic migraine by an experienced neurologist,
* For the control group, patients who were not diagnosed with migraine but applied to the headache outpatient clinic
* Volunteer

Exclusion Criteria:

* Being younger than 19 years and older than 64 years of age, having a history of cardiovascular disease, hypertension, diabetes, cancer, liver and kidney disease or other neurological disorder (epilepsy, multiple sclerosis, stroke, traumatic brain injury, etc.), secondary headache, antilipidemic and glucose taking intolerance medications or vitamin-mineral supplements, following a special diet, and consuming less than 800 kcal or more than 4000 kcal per day
Safety and Efficacy of Romiplostim in Immune Thrombocytopenia (ITP) in the " Real-life " : Result of the French Experience in 72 Adults

The purpose of this study is to review the charts of the first 100 patients included in the french compassionate program including patients with Immune Thrombopenia receiving romiplostim.

Inclusion Criteria:

* Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996).
* Subject is equal to or greater than 18 years of age.
* Before any study-specific procedure, the appropriate written informed consent must be obtained.
* Subject receiving romiplostim in the compassionate program
* Available follow-up of one-year

Exclusion Criteria:

•Secondary ITP e.g: thrombopenia related to hepatitis C, HIV, Chronic Lymphocytic Leukemia...

The goal of this study is to review retrospectively the charts of the 100 first patients including in this program in France during the period of January 2008 and July 2008.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion Criteria:

  * Subject has a diagnosis of ITP according to the American Society of Hematology guidelines (George et al., 1996).
  * Subject is equal to or greater than 18 years of age.
  * Before any study-specific procedure, the appropriate written informed consent must be obtained.

Exclusion Criteria:

* Exclusion Criteria:

  * Secondary ITP