cyrilzakka/clinical-trials huggingface dataset:
Effects of an Exercise Program on Cognition and Brain in Overweight/Obese Preadolescent Children

The ActiveBrains project aims to examine whether a 5-months physical exercise program has benefits on cognition and brain, as well as on selected physical and mental health outcomes in preadolescent overweight/obese children.

New advances in neuroelectric and neuroimaging technologies in the last years provide a golden opportunity to further explore and understand how cognition and brain function can be stimulated by environmental factors, such as exercise, and particularly to study whether physical activity influences brain development in early ages. The present study, namely the ActiveBrains project, aims to examine the effects of a 5-months physical exercise program on cognition and brain, as well as on selected physical and mental health outcomes in preadolescents overweight/obese children.

A total of 100 overweight/obese preadolescent children aged 9 to 10 years will be randomized into an exercise group (N=50) and a control group (N=50). For practical and feasibility reasons, the study will be conducted in 2 waves, a 1st wave with a sample of 30 and a 2nd wave with a sample of 75. In this regard, 15 children will be intervened within one academic year (5-month intervention) and 35 children will be intervened within the following academic year. The control group will receive the usual physical education sessions (2 per week). In order to study the extent to which the effect of the intervention remains or disappears once the formal intervention is finished, we will do a 3rd evaluation in a subsample (50 participants from the 1st wave) 9 months after the intervention has finished. Waitlist control group strategy will be used, through which the control group will also receive an after-school exercise program but later, after all the assessments of the effectiveness of the program have been completed.

Based on existing literature, we believe that a 5-months physical exercise program is potentially beneficial for the cognition and brain, and for the physical and mental health of the overweight/obese children participating.

Eligibility Criteria:
Inclusion Criteria:

* Preadolescent children of Tanner stage of I, II or III.
* Children of 8 to 11 years-old,
* Overweight or obese defined based on the sex-and-age specific body mass index standards of Cole (2002).
* Girls must not have menstruation.

Exclusion Criteria:

* Children with Attention-Deficit Hyperactivity Disorder or any other psychiatric disorder.
* Left-handed children.
* Children with medical problem that prevent to practice physical activity.
Glucose Tolerance in Patients With an Idiopathic Parkinson's Disease

Dysfunction of autonomic nervous system is an important non motor feature of Parkinson' disease (PD). Lewy body formation is widely distributed in hypothalamus and in sympathetic and parasympathetic systems. Animal studies suggest a link between hypothalamus sensing of substrates and glucose metabolism. Thus, hypothalamus lesions could lead to change in glucose metabolism. Recently, we showed that fasting blood glucose level was significantly higher in PD patients than in control group suggesting that glucose tolerance may be impaired in PD. Some studies provided evidence for higher diabetes prevalence in PD patients whereas others showed no difference or a reduced risk of diabetes prevalence in PD patients compared to healthy subjects.

So, the risk that a PD patient develops a glucose intolerance or a diabetes is not clearly established and merit to be studied considering the damageable consequences for patient healthy.

The aim of this prospective study was to determine the risk that a PD patient develop a glucose intolerance or a diabetes compared to a matched control group, using an oral glucose tolerance test (OGTT).

50 patients

Inclusion visit :

* Clinical examination/ Interview on health and medical history
* Complete UPDRS, MMS
* Biologic check up

Protocol :

All patients were studied in the postabsorptive state after a 10-h overnight fast.

On the day of the experiment, patients did not receive their treatment. One catheter was inserted for blood sample collections. Patients ingested then 75 g of glucose.

Blood samples were collected for plasma glucose and plasma insulin concentration analyses at T0, T30, T60, T90, T120, T150 and T180. Urinary glucose was researched at T0 and T120.

In parallel, a dysautonomia evaluation of each patient was made (SCOPA AUT questionnaire, Tilt test).

Eligibility Criteria:
Inclusion Criteria:

* Age : 18-70 years
* Patient with an idiopathic Parkinson's disease according to the criteria of the "Parkinson's Disease Society Brain Bank" with a duration of disease \>5years
* MMS\>24/30
* No treatment modification 7 days before the inclusion
* Affiliation to social security
* Agreement of patients

Exclusion Criteria:

* Patient treated with antibiotics, AINS, AIS or other treatment which could interfere with the protocol
* Patients with significant heart, respiratory, psychiatric, metabolic, hepatic, kidney diseases; diabetes, heart deficiency, chronic kidney deficiency, untreated thyroid disease ...
* Patient treated with a deep brain stimulation
* Patients with metabolic and/or biological anomalies
* Pregnant women
* Medical or chirurgical previous history which could interfere with the protocol
* Alcohol (\>30g/day); Tobacco (\>10 cigarettes/day)
* Participation to an other study at the same time
Preoperative Carbohydrate Drink Prior to Elective Caesarean Section

Prior to caesarean section, patients should fast from solid food for 6 hours and from clear fluids for 2 hours. Carbohydrate drinks can also be consumed up to 2 hours before surgery. These drinks have been shown to improve patient well-being after surgery and may potentially improve the neonatal blood glucose level after delivery and reduce the risk of a low blood glucose level. This study aims to assess the influence of pre-operative carbohydrate drinks on blood glucose levels of the baby at delivery.

Patients recruited to the study will be randomised to one of 3 groups.

Group 1 will receive standard care as per our current practice. This includes fasting from solids for 6 hours prior to surgery and clear fluids for up to 2 hours prior to surgery.

Group 2 will receive a carbohydrate (CHO) drink preoperatively as well as adhering to standard care. Patients will be allowed to drink this CHO drink as required from admission to hospital on the morning of their surgery. They will also receive a further 400ml bolus at 2 hours prior to surgery.

Group 3 will receive an apple juice drink preoperatively as well as adhering to standard care. Patients will be allowed to drink this apple juice drink as required from admission to hospital on the morning of their surgery. They will also receive a further 400ml bolus at 2 hours prior to surgery.

Before the start of surgery, the patients non-dominant hand grip strength will be assessed using the dynamometer. Their subjective sense of thirst and hunger will be assessed. Their fasting times for food and fluids will be recorded. The patients' blood glucose will be measured from a blood sample as their intravenous cannula is inserted. The maternal urinary ketones will be measured from a urine sample upon insertion.

The neonatal blood cord glucose will be measured from both an arterial and venous cord blood sample after delivery. This will be performed by the trained anaesthesia research fellow. Should hypoglycemia be identified, the hospital's neonatal hypoglycemia algorithm will be followed appropriately.

The patients will be followed up at 24 hours by an outcome assessor blinded to the group allocation. Numerical rating scale (NRS) pain scores, postoperative nausea and vomiting and quality of recovery will be assessed at the patients beside. All neonates will be followed up to calculate admissions to neonatal unit and the number of glucose sachets required for hypoglycemia.

Eligibility Criteria:
Inclusion Criteria:

* Elective caesarean section for singleton pregnancy under neuraxial anaesthesia.
* Subjects able to give informed consent and willing to comply with the study protocol.
* Subjects must be greater than 18 years old.

Exclusion Criteria:

* Diabetes Mellitus - including gestational diabetes.
* Known foetal abnormality.
* General anaesthesia.
* Gestation \< 37 weeks.
* Steroids received within 4 days of delivery.
* Low birth weight 2.5 kg (IUGR)
* BMI \> 40 kg/m2
Managing Pain in Patients With Plantar Fasciitis - A Blinded Randomized Controlled Trial

Plantar fasciitis (PF), a leading cause of persistent heel pain, results in almost a million physician visits annually. Conservative treatment is often the first line of management with insoles being frequently prescribed. While multiple studies have compared insoles based on the degree of customization to foot contour, the literature is lacking in data comparing insoles based on their material. In this randomized clinical trial, we compared the early effects of polyethylene (PE), polyurethane (PU), and carbon fiber insoles in the treatment of PF, using a set of patient-reported outcomes.

Carbon fiber insoles (VKTRY, Milford, CT, USA) were initially designed to increase ground forces leading to a harder push off for faster running or higher jumping. To enable energy return, the insoles require extreme rigidity and therefore are composed of a full-length carbon-fiber base. The highly rigid construct of the carbon fiber can potentially benefit patients with plantar fasciitis by using these insoles in their own shoes, which could lead to more effective pain management, increased compliance, and improved patient outcomes. While this insole is currently being widely used by athletes, the application of this insole for PF patients has not been explored. Therefore, the aim of this study is to understand how patients respond to the these insoles compared to current standard orthotics (Superfeet Green, Superfeet Worldwide LLC. WA, USA and Aetrex L20, Aetrex Inc, NJ, USA) in a blinded randomized controlled trial.

Eligibility Criteria:
Inclusion Criteria:

* Adult patients (over 18 years old) with plantar fasciitis
* Adults who are competent and able to consent on their own behalf
* Patients who are seen at MGH Boston, MGH Waltham and Newton Wellesley Hospital

Exclusion Criteria:

* Patients who received an injection in the last 6 months in their plantar fascia
* Patients who will need to be treated surgically
* Patients who are non-English speaking
Oral Misoprostol Solution in Comparison to Vaginal Misoprostol in Induction of Labor

Induction of labour at term is a common obstetric intervention. Induction of labour is the artificial initiation of labour before its spontaneous onset for the purpose of delivery of the fetoplacental unit using mechanical or pharmacological methods.

To determine the effects of oral misoprostol solution compared to vaginal misoprostol in induction of labour.

Patients recruited in the study will be primigravida at term with obstetric or medical indication for labour induction. These patients will be either booked attending antenatal clinic referred for induction of labour or emergency admissions in labour room.

A total of 100 women will be randomly selected for the study. I. Women will be given 20 ml (20 µg) of misoprostol solution orally every 2 hourly until adequate uterine contractions occurred (3 contractions per 10 min lasting 30-40 s).

II. The induction regimen included application of Vagiprost 25 µg tablet in the posterior fornix of the vagina every 4 h (up to 6 doses) after determination of the Bishop score.

Eligibility Criteria:
Inclusion Criteria:

* Primigravida or Primipara
* Pregnancy between 36 and 42 weeks of gestation.
* A live singleton fetus in cephalic presentation.
* No history of uterine surgery.
* Clinically adequate pelvis.
* Modified Bishop's score \<5.
* Reactive Non stress test (NST) .

Exclusion Criteria:

* •Known hypersensitivity or contraindications to oral misoprostol (uterine surgery).

  * Any antenatal medical complications.
  * A situation requiring LSCS (Maternal or Fetal) e.g:fetal distress
  * Non-reactive NST.
  * Patient's refusal to give consent
Effects of Individualized Training to Reduce Fatigue in Patients With Newly and Advanced Diagnosed Multiple Sclerosis

Multiple sclerosis (MS) is a chronic autoimmune inflammatory disease of the central nervous system. It is characterized by complex and heterogeneous symptoms. Chronic fatigue is the most reported symptom in MS patients (80%). Current pharmacological treatments for MS patients reduce the number of relapses and their severity but do not improve symptoms such as fatigue. Physical activity is a therapy that helps reduce this fatigue, in addition to improving muscular and cardiorespiratory functions. However, the results are not optimal because MS patients remain less active than the general population. The improvement of the benefits of exercise therapy could therefore be based on three approaches: personalization of the training program, home practice and early initiation.

The objective of this study will be to investigate the effects of individualized home-training, guided by a mobile application, to reduce fatigue in patients with newly (N) and advanced (A) diagnosed MS.

Eligibility Criteria:
Inclusion criteria

* Relapsing-remitting MS (RRMS) defined according to the criteria of McDonald
* MS diagnosed less than 2 years ago or whose first symptoms are estimated to be less than 5 years old OR MS diagnosed more than 2 years ago and whose first symptoms are estimated to be less than 5 years old
* With a high level of fatigue, corresponding to an FSS score \> 4
* Expanded Disability Status Scale (EDSS) score \< 4
* Medical Research Council (MRC) testing ≥ 4 in all leg muscles
* Ability to walk for 10 minutes without stopping (self-reported)
* Have a mobile phone with internet access
* Affiliated with or benefiting from a social security scheme
* Have freely given their written consent after being informed of the aim, the procedure and the potential risks involved

Exclusion criteria

* Spasticity or severe cerebellar ataxia in either leg.
* Abnormal range of movement of the toes and/or ankle
* Musculoskeletal injury that impairs pedalling
* Appearance of a multiple sclerosis attack in the 90 days preceding the study
* Recent adjustment of any medication or drug that may have an impact on fatigue: treatment of neuropathic pain: anti-epileptic and/or taking stimulants for fatigue (e.g. modafinil, amantadine, fampridine...)
* History of comorbid illness or conditions that would compromise the subject's safety during the study
* Participation at the same time in another medical intervention study or having participated in such a study in the 30 days prior to this study
* Pregnant and breast-feeding women
* Patients who are unable to understand the purpose of the study and the conditions under which it will be conducted, or who are unable to give their consent.
* Patients deprived of their liberty or under guardianship
Investigating the Role of EN in NTIS Among Fistula Patients

The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Nonthyroidal illness syndrome (NTIS) is a common alterations in thyroid function observed in about 70% of hospitalized patients, with or without acute systemic illnesses. Mechanisms in the pathogenesis of NTIS are not yet well understood. Our previous study demonstrated that NTIS occurred frequently with a prevalence of 57.5% in gastrointestinal fistulas patients. In recent study, it has been shown that early enteral nutrition decreases the duration of hospitalization and mortality in the burn population, indicating a potential role of enteral nutrition in NTIS.In addition, the management of fistula patients requires bundle therapy including Nutrition therapy, especially enteral nutrition.The purpose of this study is to investigate whether enteral nutrition are effective in the treatment of nonthyroidal illness syndrome among fistula patients.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of gastrointestinal fistula
* Clinical diagnosis of nonthyroidal illness syndrome
* Using enteral nutrition for fistula management

Exclusion Criteria:

* patients who were prescribed drug which may affect thyroid function before or in our study
* patients who were diagnosed as primary thyroid disease
Escitalopram and Depression in Elderly Alzheimer's Patients

To investigate the effect of Escitalopram in a large and diverse of dementia patients suffering from depression.

This study will assess the efficacy, tolerability, and safety of escitalopram in the treatment of Major Depressive Disorder in patients with Alzheimer's disease over a 24-week period. It will also assess the efficacy and tolerability of escitalopram after 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* \> 50 years
* Male \& female
* Alzheimer's disease
* Depressive episode
A Double Balloon Endoscopic Platform for ESD

The purpose of this observational study is to record performance of a double balloon endolumenal interventional platform during complex colon polypectomy.

Endoscopic removal of Complex colon polyps (benign polyps \>=2cm) is a technically challenging procedure. Complex benign polyps have a greater chance of becoming cancerous if not removed.

The DiLumen™ Endolumenal Interventional Platform is a non-sterile, single-use, close-fitting sleeve that fits securely over a standard endoscope to stabilize it in the large intestine, and facilitates use of the endoscope for optical visualization, diagnosis, and treatment. The device is indicated to ensure complete positioning of an endoscope in the large intestine and assist with optical visualization, diagnosis, and endoscopic treatment.

The device received 510k clearance on Dec 6, 2016. The study will evaluate performance of the device during routine, scheduled, endoscopic polyp removal for these large polyps.

Eligibility Criteria:
Inclusion Criteria:

* Subjects \> 18 years of age
* Subjects scheduled for endoscopic removal of suspected complex adenomatous polyps in the large intestine which are sessile or polypoid lesions ≥ 2cm, near the ileocecal valve, dentate line, over a fold, or at a flexure; and or lesions tethered to the colon wall due to previous incomplete resection
* Subjects willing and able to give informed consent
* Subjects who in the opinion of the Principal Investigator have no medical contraindication to endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD)

Exclusion Criteria:

* Subjects with a contraindication to colonoscopy, including but not limited to active colitis, perforation, or stricture.
* Subjects with a history of open or laparoscopic colorectal surgery
* Subjects with a history of Inflammatory Bowel Disease (IBD)
* Subjects with a suspected malignancy on polyp assessment
Peripheral Oxytocin and Touch

Research shows that slow gentle skin stroking can activate special sensory nerves in the skin that elicit relaxing effects on the body and mind, similar to the effects of the hormone oxytocin. Studies also suggest that gentle stroking may even release oxytocin in the skin. However, we do not know what oxytocin does in the skin and how it affects nerves that send pleasant touch or pain signals to the brain. The proposed study will determine how individuals perceive gentle stroking and experimental pain before and after a skin injection of oxytocin compared to a placebo injection.


Eligibility Criteria:
Inclusion Criteria:

1. Between the ages of 18 and 65 years old
2. Fluent in English
3. Healthy

   Exclusion Criteria:
4. Sensory or motor nerve deficit
5. Acute or chronic pain
6. Major medical conditions such as kidney, liver, cardiovascular (hypertension, preexisting cardiac arrhythmia), autonomic, pulmonary, or neurological problems (e.g., seizure disorder) or a chronic systemic disease (e.g., diabetes).
7. Any disease, diagnosis, or condition (medical or surgical) that, in the opinion of the Principal Investigator, would place the subject at increased risk (active gynecologic disease in which increased tone would be detrimental e.g., uterine fibroids with ongoing bleeding), compromise the subject's compliance with study procedures, or compromise the quality of the data
8. Unstable psychiatric conditions
9. Needle phobia or history of fainting
10. Current use of opiate medication(s)
11. Hypersensitivity, allergy, or significant reaction to any ingredient of Pitocin®
12. Currently pregnant or pregnant within the last two years
13. Currently nursing or lactating
14. Current or history of ventricular tachycardia, atrial fibrillation or prolonged QT interval
15. Past or current history of hyponatremia or at risk for hyponatremia
16. Current use of thiazide diuretics, loop diuretics, combination diuretics, lithium, carbamazepine, enalapril, Ramipril, celecoxib, temazepam, gliclazide, glimepiride, glibenclamide, glipizide, omeprazole, pantoprazole, desmopressin, selective serotonin reuptake inhibitors, monoamine oxidase inhibitora, or the recreational drug ecstasy
17. Latex allergy
SWOG-9208 Quality of Life and Health Status in Patients With Stage I or Stage II Hodgkin's Disease

RATIONALE: Quality-of-life assessment in patients undergoing cancer treatment may help determine the intermediate- and long-term effects of treatment on patients with cancer.

PURPOSE: This clinical trial studies the impact of therapy on the health status and quality of life of patients with stage I or stage II Hodgkin's disease who are receiving radiation therapy with or without chemotherapy.

OBJECTIVES: I. Evaluate prospectively the health status and quality of life of patients with Stage I/IIA Hodgkin's disease randomized on protocol SWOG-9133 (CLB-9391) to treatment with subtotal nodal irradiation with vs. without 3 courses of doxorubicin/vinblastine. II. Describe the short-term effects of these treatments on these patients and compare their impact on quality of life (i.e., patient symptom status, health status, fatigue). III. Evaluate the intermediate and long-term effects of these treatments on these patients and compare their impact on quality-of-life outcomes over 5 years.

OUTLINE: Quality-of-Life Assessment. Cancer Rehabilitation Evaluation System Short Form, CARES-SF; Symptom and Personal Information Questionnaire (including Symptom Distress Scale, MOS SF-36 Fatigue Scale, MOS SF-36 Health Perception Rating, Demographics); Cover Sheet.

PROJECTED ACCRUAL: Approximately 500 patients will be accrued over 7 years.

Eligibility Criteria:
DISEASE CHARACTERISTICS: Patients must be eligible for and registered to SWOG-9133

PATIENT CHARACTERISTICS: Patients must be able to complete the questionnaires in English. If they are not able to complete questionnaires in English, patients may be registered to SWOG-9133 without participating in SWOG-9208.

The Symptom and Personal Information Questionnaire #1, the Cancer Rehabilitation Evaluation System Short Form (CARES-SF) and Cover Sheet must be completed prior to registration and randomization on SWOG-9133.