cyrilzakka/clinical-trials huggingface dataset:
Sleep Disorders in Pediatric Dialysis

Sleep disorders (SD) are common in adults with Chronic Kidney Disease (CKD) on dialysis with a reported prevalence of 60-80%. To date three studies have reported on SDs in children with CKD but these have all been based on questionnaire data alone. The findings were not confirmed with polysomnograms (PSG), the gold standard to diagnose SD, or actigraphy, a validated tool to assess the sleep/ wake cycle over a prolonged period in the home. This is highly relevant given the poor sensitivity and specificity of even validated questionnaires alone. The effect of untreated pediatric SD is pervasive. This study will provide the first objective assessment of SDs using PSGs in children with severe CKD, both on and off dialysis. Therefore, we will recognize and when possible treat SD in this severe CKD cohort potentially contributing to their immediate management (eg improved control of hypertension, improved school performance), while improving their Quality of Life (QOL) and helping ensure they achieve their full potential.


Eligibility Criteria:
Inclusion Criteria:

* 0 to 18 years
* Caregivers must be able to read English
* Patients with either Stage 4 Chronic Kidney Disease (CKD) with an estimated GFR of 15-30 ml/min/1.73m2 based on IDMS Schwartz GFR OR patients with CKD receiving outpatient hemodialysis (HD) or peritoneal dialysis (PD) for a minimum of 1 month
* Informed consent

Exclusion Criteria:

* Caregivers cannot read English
* Informed consent not given
Hypoxic Burden and Sleepiness in Treated OSA Patients

The Maintenance of Wakefulness Test (MWT) is widely used to objectively assess sleepiness and make safety-related decisions and Epworth Sleepiness Scale (ESS) is the most used scale used to assess subjective sleepiness in sleep medicine.

Besides Obstructive Sleep Apnea measures are rapidly evolving and conventional measures such as apnea-hypopnea index (AHI) and oxygen desaturation index (ODI) are increasingly being supplemented by measures of hypoxia such as hypoxic burden.

Residual AHI in treated OSA have limited predictive value for objective sleepiness. Therefore it seems particularly relevant to identify other predictors of both subjective and objective sleepiness.

This study aims at studying the influence of hypoxic burden as measure of both subjective or objective sleepiness.

We hypothesize that impaired nocturnal oxygenation might influence brain functioning during wakefulness and result in sleepiness as assessed by ESS and MWT.


Eligibility Criteria:
Inclusion Criteria:

* OSA hospitalised to undergo both polysomnography (PSG) and the 40-min MWT in the Center for Sleep Medicine and Respiratory Disease, Lyon Academic Hospital from September 2017 to March 2020.

Exclusion Criteria:

* - age \&lt;18 years
* refusal to participate in the study
* diagnosis of central disorder of hypersomnolence
* missing data on the MWT
* Epworth Sleepiness Scale (ESS)
* apnea-hypopnea index (AHI).
The Effect of Transcranial Direct Current Stimulation Upon Sleep Spindles in Healthy Older Adults

A good quantity, and quality, of sleep is crucial for well-being. Evidence strongly indicates that poor sleep quality and quantity is causally involved in the development of dementia; therefore, techniques which can improve sleep in older adults are very likely to prevent or slow down the disease process in dementia.

This project aims to manipulate a specific aspect of sleep in healthy older adults. This: 1) has the potential to prevent the pre-dementia stage of mild cognitive impairment in healthy older adults, and 2) has a direct clinical application to dementia. The overall aim of this project is to investigate if a non-invasive brain stimulation technique called transcranial direct current stimulation (tDCS) can enhance specific brain activity patterns during overnight sleep in healthy older adults.

These brain activity patterns during sleep (called 'sleep spindles') are mechanistically linked to both the physiological restorative and the cognitive function of sleep. Sleep spindles can only be assessed by measuring overnight brain activity during sleep. Sleep spindles are very strongly associated with attention, and memory performance, which are severely affected by dementia. A decrease in sleep spindles is associated with cognitive decline, and predict dementia development. Therefore, enhancing sleep spindle activity in sleep is likely to boost cognition.

Whilst previous research studies have demonstrated that in a sleep laboratory environment, tDCS can manipulate sleep spindles when individuals are in a specific brain state in a nap situation, we are specifically interested in testing tDCS in a home environment. This is because the use of tDCS in a home environment has have a number of advantages over sleep laboratory studies. Specifically, by conducting this study in a home environment, this will maximise the inclusivity of studies involving older adults, and DLB patients, since they will not be required to travel to a sleep laboratory to participate in studies.

The aim of this proof-of-principle study is to investigate if tDCS can manipulate sleep spindles in healthy older adults. It is expected that relative to a placebo stimulation, active stimulation (which exerts an effect upon the brain) will increase sleep spindle activity in healthy older adults.


Eligibility Criteria:
Inclusion Criteria:

• Healthy sleeper older adults aged ≥ 60 years

Exclusion Criteria:

* The presence of self-reported neurodegenerative dementia or other neurological disorders
* Self-reported relevant sleep disorders or disturbances
* Relevant skin allergies
* Concurrent major psychiatric illness
* Significant/severe physical illness or comorbidities
* Metallic or electronic implants
Examination of Cognitive Function in Patients Treated With Subutex

People who addicted to Heroin and other opiates suffer from a disease with approved genetic basis. It causes to a behavioral response as searching and using those drugs even though they know it causes severe damages as physiological, familiar and legal affairs.

The popular treatment's goal is to "clean" the people from any drug. In a medical and pharmacological point of view there is no sense in this approach for all people. This point of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment.

The hypothesis of this research is that people using Buprenorphine have difficulties in gaining weight, in sexual and cognitive function (according to subjects' reports)

People who addicted to Heroin and other opiates suffer from a disease with approved genetic basis. It causes to a behavioral response as searching and using those drugs even though they know it causes severe damages as physiological, familiar and legal affairs.

The popular treatment's goal is to "clean" the people from any drug. In a medical and pharmacological point of view there is no sense in this approach for all people. This point of view believes that Buprenorphine (Subutex) is a correct pharmacological treatment.

The hypothesis of this research is that people using Buprenorphine have difficulties in gaining weight, in sexual and cognitive function (according to subjects' reports) We examine people who stopped opiates and began Buprenorphine. Every participant in the study will have two visits: the first one before receiving Buprenorphine and the second one after 3 months of receiving Buprenorphine.

Eligibility Criteria:
Inclusion Criteria:

* People who suffer from addiction problems (opiates)
* People who willing to to start Buprenorphine treatment
* People who willing to cooperate with study tests and questionnaires
* People aged 18 to 70

Exclusion Criteria:

* People who suffer from any neurocognitive problems
* People who suffer from mental illnesses
* People who are having legal guardian
Decision Making, Daily Experiences, and Brain Activity in Young Adult Women

The investigators are doing a study of women with and without binge-eating disorder to learn more about what happens when people engage in everyday decision-making activities. The investigators are interested in learning more about brain activity during everyday decision-making and how everyday decision-making relates to a variety of daily experiences. Examples of everyday decisions include deciding which product to buy, deciding what to eat for a snack, and deciding how to spend free time.


Eligibility Criteria:
INCLUSION CRITERIA:

Inclusion Criteria for All Participants:

* Normal or corrected to normal vision and hearing
* Verbal and written fluency in English
* Right-handed
* Body mass index of 20-35 kg/m\^2

Additional Inclusion Criteria for Participants with Binge-Eating Disorder:

• DSM-5 binge-eating disorder

EXCLUSION CRITERIA:

Exclusion Criteria for All Participants:

* Impaired cognition or other neurological/cognitive problems
* Contraindications to MRI (e.g., certain metal implants, claustrophobia)
* Currently/recently/potentially pregnant, seeking to become pregnant in the near future, or breastfeeding
* Serious and/or unstable medical diseases and conditions, and certain other medical diseases and conditions
* Recent low weight
* Certain medications (e.g., insulin)
* Current/recent frequent recreational drug use, or history of frequent recreational drug use in early adolescence
* Extreme dietary limitations (e.g., veganism), pervasive food allergies, or limited exposure to popular snack foods
* Current/recent suicidality
* Current/recent changes in treatment for mental illness
* Study-relevant research experience

Additional Exclusion Criteria for Comparison Participants:

* Personal history of eating disorders or recurrent binge eating
* Personal history of any other mental illness, including serious substance use problems
* First-degree relative with current or past eating or psychotic disorder
* Significant recent change in weight

Additional Exclusion Criteria for Participants with Binge-Eating Disorder:

* Severe mental illness (e.g., psychotic disorder, severe agoraphobia)
* Certain other current/recent mental illness, including severe substance use problems, that would limit study participation or safety
* Recent anorexia nervosa spectrum disorder, avoidant-restrictive food intake disorder, or bulimia nervosa spectrum disorder
Abnormal Fecal Microbiota in Healthy Subjects at High Risk for Crohn's Disease

Transversal multicentric French study on the microbiota in patients with Crohn's disease and their first degree healthy relatives The primary objective is the comparison of microbiota between patients with CD, healthy controls non genetically linked and first degree healthy relatives of patients with CD.

Crohn's disease is a chronic inflammatory bowel disease associating flares and remission periods. Its etiology is unknown and there are no specific therapy. CD affects young patients and has a major impact on quality of life. There are few population-based studies and there are about 2.5 million affected patients in Europe and North America. From data from EPIMAD Registry the number of affected patients in France should be 200 000. The Crohn's disease pathogenesis is bad known; It coul be the results of the activation of the gastro-intestinal immune system toward gut microbiota in genetically susceptible hosts. In CD patients there is an important ecologic modification of the flora with an excess of Bacteroidetes and Proteobacteria and a decrease of anti inflammatory bacteria (Firmicutes). In ileum of CD patients a specific E Coli (adherent and invasive E Colo) is found in two thirds of cases.The presence of this AIEC seems to be associated to the variant NOD2 (results from our team in multiplex families).

In a family with at least 1 patient with CD, the healthy first degree relatives present a high risk (\* 10) to also develop a CD.

The primary objective is the comparison of microbiota between patients with CD, healthy controls non genetically linked and first degree healthy relatives of patients with CD. The first endpoint is the Lachnospiraceae rates in each group.

The secondary objectives are :

1. the search for an association between bacterial dysbiosis and different genetic backgrounds in patients with CD, their first degree healthy relatives and controls.
2. the quantification of potential invasive bacteria with invasive properties (E. coli including adherent-invasive E. coli, Shigella, Salmonella, Yersinia, Campylobacter), and fecal fungal flora (Candida albicans, in particular) and their association with genetic and serological profiles in patients with CD, their healthy relatives and control subjects.
3. a study of environmental risk factors using a questionnaire to be submitted to CD patients, their healthy relatives and control subjects.

Eligibility Criteria:
Inclusion Criteria:

Patient with Crohn's disease

* Patient \> 18 years old
* Having at least one first degree health relative
* OK to participate to the project

First degree healthy relatives

* specific clinical questionnaire and dosing fecal calprotectin to ensure the absence of inflammatory pathology.
* OK to participate to the project

Exclusion Criteria:

* Intestinal resection.
* Pregnant or breastfeeding woman.
* subject under guardianship
* subject does not speak French
* person unable to speak
* taking antibiotics or bowel preparation will push 6 weeks stool specimens, after cessation treatments.
Treatment of Chronic Low Back Pain: A Trial Comparing Traditional Back School and Individual Therapist-Assisted Exercise

Rheumatologists are discussing, whether rehabilitation of patients with low back pain (LBP) can be improved. At present patients with LBP start treatment as soon as possible, this also applies for patients with chronic low back pain (CLBP) - pain lasting over 12 weeks. At Glostrup University Hospital department of Physical Medicine/rheumatology we use a method (method A) where an interdisciplinary team gives the patients a treatment composed of various topics. This includes among other things education, physical team training, exercises in swimming pool, stretching exercises, and occupational therapy. A different method (method B) originates from the Rehabilitation centre in Karlslunde led by Teddy Oefeldt. Here they focus strictly on dynamic training of muscles in the back and the buttocks. A therapist, who in the beginning partly carries the patient through the exercises, assists this training.

In both methods, individually considerations are taken, but to a greater extend in method B. The treatment will extend over a three months period.

A few earlier investigations have compared these two methods, but they have not been systematized to such a degree, that they gave any final conclusions. Therefore, we initialized an investigation including a larger number of patients, where the two methods are compared from the results the patients achieve after 3, 6, 12 and 24 months.

286 consecutive patients were included and randomized to one of the two methods. Those, who did not wish to participate in the investigation, were treated according to the department's normal procedure (Method A)


Eligibility Criteria:
Inclusion Criteria:

1. Low Back Pain lasting more than 12 weeks with or with out pain radiating into the leg(s)
2. Age 18 - 60 years

Exclusion Criteria:

1. Serious spinal pathology

   1. Malignancy
   2. Osteoporosis,
   3. Fresh vertebral fracture
   4. Newly operation on the back
   5. Stenosis of the lumbar spine
   6. Unstable spondylolistesis
   7. Infections in the back
2. Neurological dysfunction of the thoracic or abdominal muscles
3. Pregnancy/breastfeeding
4. Mental illness
5. Health conditions which prohibit intensive training.
6. Languish problems/ dyslexia
Effect of Powerbreath Versus Transcutaneous Electrical Diaphragmatic Stimulation on The Severity of Copd

Chronic obstructive pulmonary disease (COPD) is a common and treatable disease characterized by progressive airflow limitation and tissue destruction. It is associated with structural lung changes due to chronic inflammation from prolonged exposure to noxious particles or gases most commonly cigarette smoke.

POWERbreathe device (POWER-breathe International Ltd., Southam, Warwickshire, UK) is an inspiratory muscle training and this device has recently shown benefits on pulmonary function. Also, the POWER-breathe® device's effects on the strength of the diaphragm muscle and minimize muscle weakness and wasting in COPD patients.

Neuromuscular electrical stimulation (NMES) is commonly used in physical therapy to increase muscle strength and promote muscle hypertrophy. NMES applied to respiratory rehabilitation is called transcutaneous electrical diaphragmatic stimulation (TEDS).

sixty Patients will be assigned randomly into two equal groups with pre and post treatment protocol application.

Group A:

Thirty patients will be treated by power breathe along with their prescribed medication.

Group B:

Thirty patients will be treated by Transcutaneous electrical Diaphragmatic Stimulation (TEDS) along with their prescribed medication.

Eligibility Criteria:
Inclusion Criteria:

* The patient selection will be according to the following criteria:

  1. Male patients diagnosed with stage 2\&3 COPD.
  2. All patients are under full medical control.
  3. Their ages will range from forty-five to sixty-five years.
  4. Patients with BMI from 25-29.9 kg/m2

Exclusion Criteria:

* Patients with the following criteria will be excluded from the study:

  1. Lack of language or cognitive abilities to fill out questionnaire.
  2. Patients with cardiac pacemaker.
  3. Contraindications for inspiratory muscle training (e.g. a history of recent lung surgery, recent pulmonary embolism, history of recurrent spontaneous pneumothorax, other serious lung disease).
  4. Existing arterial aneurysm.
  5. Clinical signs of unstable cardiac event (eg. congestive heart failure).
  6. Patients with malignant disease.
  7. Acute COPD exacerbation within the last 4 weeks.
  8. Any need for supplemental oxygen.
  9. Patients with Gastro-esophageal reflux disease.
  10. Patients with active Hemoptysis.
Bile Acids and Microbiome in Early Colorectal Carcinogenesis

Currently colorectal cancer pathogenesis is mainly explained by the adenoma-carcinoma sequence theory that was proposed more than half a century ago. It mainly focuses on the explanation of genetic mutations that develop throughout the disease course. However, several studies argue that there are also noticeable bile acid metabolism changes and microbiome composition changes within in colorectal cancer patients. However, carcinoma is the final step in the sequence, and prior steps are noticeably less well studied. Thus, the investigators hypothesize, that changes within microbiome and the changes in the urine, serum and gut bile acid composition further leads to the development of colorectal adenoma and subsequent invasive carcinoma.

Adult participants (15 per group) referred for colonoscopy and histologically diagnosed with small (\<1cm) adenomas, large (\>1cm) adenomas, invasive CRC will be included in the study, as well as 15 healthy controls. Fecal samples will be collected from all participants before bowel preparation. Additionally, urine and serum samples will be collected. Participants will undergo polypectomy, endoscopic mucosal resections, depending on the location, size and histology of the polyp found. During colonoscopy the mucosal biopsy specimens from the lesion and from the healthy bowel -terminal ileum, and colon will be obtained using sterile biopsy forceps. The collected samples will be stored for bile acid and microbiome analysis and for possible further pathology and genetic testing. Healthy participants without visible colorectum pathology during colonoscopy will undergo colon and terminal ileum mucosal sampling.

The investigators plan to evaluate the correlation between the urine and gut microbiome changes and bile acid composition and concentration in adenoma-carcinoma sequence and possibly determine novel bile acids. In addition, fecal, urine and tissue samples will be explored for gut microbiota and bile acid composition changes in healthy and along the adenoma-carcinoma sequence, with the possibility to propose a diagnostic test.


Eligibility Criteria:
Inclusion Criteria:

- Patients that have clinical indications for colonoscopy

Exclusion Criteria:

* Pregnancy
* Immunocompromised
* Previously diagnosed colorectal diseases
* Radiotherapy to the pelvis
* Long term antibiotic use within 6 months
* Continuous use of proton pump inhibitors
Representation and Medication Use in Juvenile Idiopathic Arthritis

According to the International League of Associations for Rheumatology classification, Juvenile Idiopathic Arthritis (JIA) comprises a heterogeneous group of arthritis of unknown cause and with onset before 16 years of age, characterized by joint inflammation lasting for 6 or more weeks. Few studies exist regarding the care experience of children affected by this rheumatic condition. On the other hand, methotrexate and biologics constitute the primary treatment for children with JIA. As with adults undergoing the same treatment, adherence is critical. Difficulties for children to take the drugs have been reported. Notwithstanding, if adherence promotion in pediatric chronic conditions has been the subject of recommendations with regard to care management, the investigators lack information to understand the grounds for adherence specifically in JIA. In order to understand and decipher the parent-child adherence mechanisms and practices, the RUMAJI study will be conducted. Indeed, improving the relational approach between children and their caregivers as well as unrestricted drug adherence involves researching and understanding how appropriation of the disease and treatment could be achieved.


Eligibility Criteria:
Inclusion criteria:

* all JIA forms
* all treatment type (NSAIDs, MTX, bDMARDs)

Exclusion criteria:

- none
BlueSync Field Evaluation

The purpose of this field evaluation is to collect and evaluate information related to CareLink transmission compliance as well as patient perceived benefit of BlueSync™ and the health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™.

The primary goal is to learn how many CareLink quarterly scheduled transmissions are completed within a prescribed time period to assess CareLink scheduled transmission compliance. The evaluation will also assess adoption to remote monitoring, patient perceived benefit of BlueSync™ (how patients interact with the smart device application) and health care provider perception of the value of BlueSync™ and satisfaction with BlueSync™ (benefits experienced by clinicians that use BlueSync™).

This clinical trial information was submitted voluntarily under the applicable law and, therefore, certain submission deadlines may not apply. (That is, clinical trial information for this applicable clinical trial was submitted under section 402(j)(4)(A) of the Public Health Service Act and 42 CRF 11.60 and is not subject to the deadlines established by sections 402(j)(2) and (3) of the Public Health Service Act or 42 CRF 11.24 and 11.44).

Eligibility Criteria:
Inclusion Criteria:

* Patient will be/has been implanted with an Azure™ or Percepta™, Serena™, Solara™ CRT-P device compatible with BlueSync™ (both new and replacement devices are allowed)
* Patient must own a smart device (Smartphone or tablet) that meets system requirements and be willing to use during evaluation period
* Patient must be able to complete the required 12-month follow-up after enrollment
* Patients must be of legal age according to local law

Exclusion Criteria:

* Patient unwilling to complete required surveys during 12-month evaluation period