cyrilzakka/clinical-trials huggingface dataset:
Be a Champion! Comprehensive School Physical Activity Program

The purpose of this project is to develop a Comprehensive School Physical Activity Program (CSPAP) training protocol, and test the feasibility, acceptability, and effectiveness of its delivery in an elementary school setting.

Children across the United States are insufficiently physically active. In response, numerous physical activity (PA) interventions have been developed and tested, the majority within the school setting. Unfortunately, these have resulted in limited, if any impact on children's PA. The investigators feel that this absence of effect stems from a lack of tailoring at the school level and a resulting lack in institutionalization. To address the latter issue, the investigators feel that it is important to leverage existing resources and capitalize on existing policies. The state of South Carolina has instituted the role of "Physical Activity Coordinators" to promote PA among students across and beyond the school day. However, while these positions are mandated by state law, the individuals in these positions often lack the training and support to maximize their impact. Our long-term goal is to develop best practices to inform the national movement to train school PA Coordinators to deliver a Comprehensive School Physical Activity Program (CSPAP) within schools that can be disseminated across the country. The objectives of the current application are to: 1) modify and expand existing CSPAP training curricula for PA Coordinators; 2) deliver the enhanced PA Coordinator training in our pilot schools; 3) conduct process evaluation on the implementation of a CSPAP by the PA Coordinators, and 4) evaluate the effectiveness of the trainings to increase children's objectively measured PA. The goal of the proposed study is to determine the acceptability, feasibility, and effectiveness of properly train PA Coordinators to promote PA in elementary school children. This goal will be achieved through the following aims: AIM 1: Develop an enhanced CSPAP training course and resource toolkit for PA Coordinators. AIM 2: Determine the acceptability/feasibility of the enhanced PA coordinator training and the implementation of a Comprehensive School Physical Activity Program in an elementary school setting. AIM 3: Determine the effectiveness of trained PA coordinators to increase objectively measured PA in elementary school youth. the investigators will randomize four schools to receive the PA Coordinator training (n=2) or continue standard practice (n=2). A comprehensive process and impact evaluation will be conducted to determine acceptability of the intervention, factors influencing implementation fidelity/dose, and the effectiveness of the PA Coordinators to increase physical activity measured via accelerometry in children.

Eligibility Criteria:
Inclusion Criteria:

* Enrolled in grades 2 - 5 at the participating school sites.

Exclusion Criteria:

* Physical or mental impairment that would preclude physical activity or protocol compliance.
Evaluation of the ClariFix™ Cryotherapy Device in Subjects With Chronic Rhinitis

A multi-center, prospective, non-randomized, interventional clinical trial to assess the safety and effectiveness of the ClariFix™ device when used to ablate unwanted tissue in the nose of subjects with chronic rhinitis.


Eligibility Criteria:
Inclusion Criteria:

1. Subject is \>21 years of age
2. Subject has moderate to severe symptoms of rhinorrhea (individual symptom rating of 2 or 3), mild to severe symptoms of congestion (individual symptom rating of 1, 2 or 3) and a minimum TNSS score of 4 (out of 12) at the time of the treatment visit, which have been present for \> 6 months.
3. Subject has had documented allergy test within the last 10 years that defines whether or not subject has allergies to perennial and seasonal allergens or is willing to have one performed prior to study exit.
4. Subject has been dissatisfied with medical management, defined as usage of intranasal steroids for a minimum of 4 weeks without adequate symptom relief by the subject's assessment.
5. Subject has signed IRB-approved informed consent form

Exclusion Criteria:

1. Subject has clinically significant anatomic obstructions that in the investigator's opinion limit access to the posterior nose, including but not limited to septal deviation or perforation, nasal polyps, sinonasal tumor.
2. Subject has had any prior sinus or nasal surgery that significantly alters the anatomy of the posterior nose.
3. Subject has active nasal or sinus infection.
4. Subject has moderate to severe ocular symptoms.
5. Subject has a history of nosebleeds in the past 3 months.
6. Subject has a history of rhinitis medicamentosa.
7. Subject has had prior head or neck irradiation
8. Subject has active coagulation disorder or is receiving anti-coagulants which cannot be safely stopped for 4 weeks (excluding aspirin).
9. Subject is pregnant.
10. Subject is participating in another clinical research study.
11. Subject has an allergy or intolerance to anesthetic agent.
12. Subject has cryoglobulinemia, paroxysmal cold hemoglobinuria, cold urticaria, Raynaud's disease, and/or, open and/or infected wounds at or near the target tissue.
13. Any physical condition that in the investigator's opinion would prevent adequate study participation or pose increased risk.
Neuromuscular Ultrasound in ALS

Amyotrophic Lateral Sclerosis (ALS) is a progressive fatal neurodegenerative disease affecting motor neurons. Early diagnosis is essential for the success of clinical trials and objective biomarkers are needed for monitoring disease progression. Nerve and muscle ultrasound may provide this information.

This study will collect pilot data to evaluate the value of muscle and nerve ultrasound to identify and monitor disease progression in ALS.


Eligibility Criteria:
Inclusion Criteria:

* Subjects referred to the electromyography laboratory for ALS.

Exclusion Criteria:

* Patients with known comorbid myopathy or neuropathy will be excluded from the study.
* Patients unable to provide their own consent will be excluded.
BI 655066 (Risankizumab) Compared to Placebo and Active Comparator (Ustekinumab) in Patients With Moderate to Severe Chronic Plaque Psoriasis

The purpose of this study is to assess the safety and efficacy of BI 655066/ABBV-066 (risankizumab) for the treatment of moderate to severe chronic plaque psoriasis in adult patients.

Participants were randomized to receive either placebo, ustekinumab, or risankizumab in Part A. All participants received 2 sets of injections to maintain the blind: the placebo arm received placebo for risankizumab and placebo for ustekinumab), the risankizumab arm received risankizumab and placebo for ustekinumab, and the ustekinumab arm received ustekinumab and placebo for risankizumab. Participants who received placebo in Part A switched to risankizumab in Part B; participants who received ustekinumab or risankizumab in Part A continued to receive the same treatment (ustekinumab or risankizumab) in Part B.

Eligibility Criteria:
Inclusion criteria:

* Male or female patients with age ≥18 years at screening.
* Have a diagnosis of chronic plaque psoriasis (with or without psoriatic arthritis) for at least 6 months before the first administration of study drug.
* Have stable moderate to severe chronic plaque psoriasis with or without psoriatic arthritis at both Screening and Baseline (Randomisation):

  1. Have an involved body surface area (BSA) ≥10% and
  2. Have a Psoriasis Area and Severity Index (PASI) score ≥12 and
  3. Have a static Physician Global Assessment (sPGA) score of ≥3.
* Must be candidates for systemic therapy or phototherapy for psoriasis treatment, as assessed by the investigator.
* Must be a candidate for treatment with Stelara® (ustekinumab) according to local label.

Exclusion criteria:

* Patients with:

  1. non-plaque forms of psoriasis (including guttate, erythrodermic, or pustular)
  2. current drug-induced psoriasis (including an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium)
  3. active ongoing inflammatory diseases other than psoriasis and psoriatic arthritis that might confound trial evaluations according to investigator's judgment
* Previous exposure to BI 655066.
* Previous exposure to ustekinumab (Stelara®).
Studying a New Piece of Equipment That Can Help Plan Radiation Therapy of the Spine

Participants will receive an MRI with a custom-built MRI coil for each participant. The purpose is to find out whether this custom-built MRI coil can help doctors see the different parts of the spine as well as or better than they can with standard CT myelograms.


Eligibility Criteria:
Inclusion Criteria:

* \>/= 18 years of age at the time of treatment
* Able to give informed consent
* Consented for spine stereotactic radiation therapy
* No contraindications for CT myelograms which include:

  * Allergy to CT contrast
  * Use of phenothiazines
  * Platelet count \< 60,000 K/mcl
  * INR \> 1.5
  * VEGF inhibitor use in the past 2 weeks prior to myelogram
  * NSAID use in the past 5 days prior to myelogram
  * Renal disease
  * Creatinine \> 1.2 mg/dL
* No contraindications for MRI scans which include:

  * Newly placed glucose monitors
  * Tattoos (Tattoos for radiation therapy are allowed)
  * Presence of a cardiac pacemaker
  * Presence of an implanted cardioverter defibrillator
  * Breast tissue expander
  * Aneurysm clip
  * Any other implanted metallic (BB, bullet, shrapnel, IUD, metallic stent or filter, spinal cord simulator etc.) or electronic device which is considered MR unsafe
  * Severe claustrophobia or inability to lie flat for the duration of the study, etc.

Exclusion Criteria:

* Presence of surgical spine hardware at the region of interest
* Presence of cervical spine lesions
* History of claustrophobia
Influence of Protein Intake on Muscle Mass and Health-related Quality of Life During and After Radiotherapy

The influence of radiotherapy on the protein intake and muscle mass of patients has not been extensively investigated to date. It is also unclear whether the localization of the tumor disease and thus the radiation field have different effects. Therefore, with the pilot study presented here, we would like to record the nutritional uptake of patients before and after radiotherapy. The aim is to determine the amount of energy and protein intake as well as the timing of protein intake. Furthermore, the relationship between the timing of protein intake and muscle mass will be investigated.

Many studies have shown that cancer patients have a very high prevalence of malnutrition. Several large-scale studies have reported that 50-80% of these patients are affected by involuntary weight loss, with the extent of weight loss depending on the tumor location and the type and stage of the disease. It has been widely reported that nutritional interventions are essential in cancer patients. Nevertheless, nutritional support is still not universally accessible to all patients. Given the prevalence of nutritional risks, the treatment of lean muscle mass loss remains a challenge in clinical practice. For this reason, a multidisciplinary approach with targeted nutritional therapy is crucial to improve the quality of care in oncology. A protein level of 1-1.2 g/kg bw is suggested for the maintenance of muscle mass.However, it has been shown that this amount is not sufficient to support ALM in patients with tumor diseases. Only an amount above 1.4 g/kg bw has been associated with a positive effect on muscle mass. Adequate dietary protein intake is essential for the maintenance of numerous physiological processes, including muscle protein synthesis and muscle function. Sufficient energy and protein intake is necessary to support muscle protein synthesis. The scientific literature frequently discusses the relationship between daily protein intake and its distribution over the main meals. The evening meal is particularly important for the maintenance of ALM.

Eligibility Criteria:
Inclusion Criteria:

* Capacity to consent
* At least 45 years of age
* Sufficient knowledge of the German language
* Indication to undergo radio(chemo)therapy with at least 10 fractions

Exclusion Criteria:

* Participation in other interventional studies
* Pregnancy/breastfeeding
* Previous intake of high-calorie supplementary food or intravenous nutrition
* BMI \< 18.5
* When performing the bioimpedance measurement: patients with pacemakers, defibrillators and other implanted automatic devices
Research Study for Children With a Mother or Sister With Polycystic Ovary Syndrome

In this study, we want to find out more about polycystic ovary syndrome(PCOS). This is a common problem in about 7% of teenage girls. Problems may include irregular periods, extra hair on the face, chest and back areas. It seems that PCOS is related to a high level of male hormones and to another problem called metabolic syndrome(MBS). People with MBS may have high blood pressure, low good cholesterol, high blood fats and extra fat around the waist. Girls with MBS are at high risk for getting diabetes and heart disease.

Once enrolled in the study, you will have a physical exam done. This includes getting a medical history, height, weight, blood pressure and heart rate. We will also listen to your heart and lungs. We will also look at your skin and determine what stage of puberty you are in by looking at your breast growth and body hair. You will also have two (maybe three) blood tests. The first one is an oral glucose tolerance test (OGTT). During this test, we will have you drink an orange sugary drink and then we will draw your blood. The second test is a frequently sampled intravenous glucose tolerance test (FSIGT). During this test, we will give you insulin through one IV catheter and then we will draw blood from another IV catheter. The third test that you might have done is an ACTH test. During this test, we will draw your blood and then you will be given a dose of cortrosyn (a hormone that your body already makes) and then we will draw your blood again. You will also have two scans of your body done during your visit. There will be a Dual Energy X-Ray Scan (DEXA) and a Magnetic Resonance Imaging Scan (MRI). You will be placed in the machines and then the scanner will move over your body.

Eligibility Criteria:
Inclusion Criteria:

* Relatives with polycystic ovary syndrome
* No relatives with polycystic ovary syndrome
* Overweight
* White non-hispanic girls

Exclusion Criteria:

* Chronic Illness
* Smokers
* Already having periods
Study to Investigate Compliance With the Oral Contraceptive SH T00186D in a Flexible Extended Regimen Supported by a Dispenser With a Reminder Function

The objective of the study is to evaluate the effect of the dispenser's buzzer function on compliance with daily tablet intake of an ethinyl estradiol (EE) + drospirenone (DRSP) containing oral contraceptive (OC) in a flexible extended regimen when administered for approximately 12 months to healthy female volunteers who request contraception.


Eligibility Criteria:
Inclusion Criteria:

* Healthy female volunteers between 18 and 35 years of age (smokers up to 30 years, inclusive) who request contraceptive protection

Exclusion Criteria:

* Pregnancy or lactation (less than 3 months since delivery, abortion, or lactation before start of treatment)
* Body mass index (BMI) \>/= 30.0 kg/m2
* Presence or a history of venous or arterial thrombotic/thromboembolic events
* Repeated measurements of systolic blood pressure \> 140 mmHg and/or diastolic blood pressure \> 90 mmHg.
* Presence or history of liver tumors (benign or malignant), severe hepatic disease, jaundice and/or pruritus related to cholestasis, cholestatic jaundice associated with pregnancy or previous COC use
* Uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
* Severe dyslipoproteinemia
* Malignant or premalignant disease
* Uncontrolled thyroid disorder
* Chronic inflammatory bowel disease
* Severe renal insufficiency or acute renal failure
* History of migraine with focal neurologic symptoms
* Epilepsy
Shared Decision Making for Prescription Opioids After Cesarean Delivery

The specific aim of this study is to use a shared decision making tool to allow women who have undergone cesarean delivery (CD) to choose the amount of oxycodone the participants will be prescribed at discharge, within a range from 0-40 tablets. The study investigators will document additional information from medical record abstraction (age, race/ethnicity, medical and obstetrical conditions, previous opioid use, date of CD, indication for CD, anesthetic management during CD, duration and complications of CD, length of stay, pain medication use and pain scores on each postoperative day between CD and discharge). The investigators will then follow up with the participants by telephone at two weeks after discharge to assess the amount of opioid used, frequency of prescription refill, disposition of unused medication, and participant satisfaction with their post-cesarean pain control. The investigators hypothesize that the use of a shared decision making tool will decrease the amount of opioid prescribed while still providing participants with satisfactory pain control.


Eligibility Criteria:
Inclusion Criteria:

* Postpartum women who underwent a cesarean delivery at MGH

Exclusion Criteria:

* Non-native English speakers (identified in LMR as "non-English speaking" or "requires interpreter")
* Women with a history of chronic opioid abuse (identified in LMR as "opioid abuse" or "narcotic abuse")
* Chronic pain on opioids (identified in LMR as "chronic pain" or "chronic narcotic use")
* Women on methadone or buprenorphine for treatment of opioid addiction (identified from their medication list in the LMR)
* Women with impaired decision-making abilities
* Women hospitalized for \> 7 days related to CD
* Minors (\<18 years old)
* Women being prescribed an opioid other than oxycodone during their postpartum hospitalization (identified from the MAR and discussion with rounding providers)
* Women with contraindications to taking acetaminophen or NSAIDs
Safety, Pharmacokinetics and Pharmacodynamics of Two IDegAsp (One Explorative) Preparations and Two Insulin Degludec (One Explorative) Preparations in Japanese Subjects

This trial is conducted in Asia. The aim of this trial is to assess the safety, pharmacokinetics (the exposure of the trial drug in the body) and pharmacodynamics (the effect of the investigated drug on the body) of two insulin degludec/insulin aspart (IDegAsp) preparations and two insulin degludec (insulin 454) preparations in healthy Japanese male subjects. IDegAsp 45 (B) and insulin degludec (B) are explorative formulations, not similar to the proposed commercial formulations.


Eligibility Criteria:
Inclusion Criteria:

* Healthy Japanese male subjects
* Body mass index (BMI) between 18.0 and 27.0 kg/m\^2 (both inclusive)
* Body weight above or equal to 50 kg

Exclusion Criteria:

* The receipt of any investigational drug within 16 weeks prior to this trial (the planned first dosing)
* Any clinical laboratory values deviated from the reference range at the laboratory (except for cases within physiological change) or any abnormal electrocardiogram (ECG) findings at the screening, as judged by the investigator or sub-investigator
* Known or suspected allergy to trial product(s) or related products
Safety & Effectiveness of Clobex Spray, Followed by Calcitriol Ointment in Management of Plaque Psoriasis

The primary objectives of this study are to evaluate the safety \& efficacy of consecutive treatments of Clobex® Spray and Silkis® Ointment in the management of plaque psoriasis.

Same as above.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of moderate to severe plaque psoriasis, defined as 3% - 20% treatable body surface area
* Overall Disease Severity of at least 3 (moderate)

Exclusion Criteria:

* Surface area involvement too large (\>20% BSA)
* Psoriasis involving only the scalp, groin, axillae, and/or other intertriginous areas
Effect of Cannabis on Simulated and Actual Driving in Healthy Subjects

Assess the effect of cigarette smoking of tobacco with or without addition of resin cannabis on driving performance in healthy volunteers in simulated driving in Marseille and Toulouse, and in real world driving to Bordeaux.

Multicenter Study of phase 1, randomized, double-blind, cross plan, carried out in healthy male volunteers.

* To compare performance data driving with the data self-assessed on the ability to drive, and the level of sleepiness and fatigue
* To measure the effects of distractive task on driving performance, consisting of a conversation with co-driver of the real or simulated vehicle (a series of difficult questions involving reflection)
* To validate the (known) effects of cannabis
* To adapt equipment and standardize methods for the pharmacological studies evaluating other types of substances having an impact on driving (antihistamines, antidepressants, antiparkinsonian ...) and other populations of subjects (men versus women, young versus elderly, healthy versus sick ...)
* To compare data obtained under conditions of simulated driving and actual driving situation, under identical experimental conditions (volunteers, narcotic substance, experimental) and measure the degree of ecological validity of the simulation of driving

Eligibility Criteria:
Inclusion Criteria:

* Weight +/- 10% of ideal weight
* Tobacco smoker moderate
* Having already smoked of the cannabis (less 1 time per month)
* Not consuming in a way exaggerated by some coffee, tea or cola
* Not having acute or chronic pathologies
* Normal electrocardiogram
* Not taking a drug interfering with the study
* Not presenting disorder of sleeping
* Having a driving license for at least 3 years and driving more 3000 km per year
* Normal acuteness or corrected visual acuteness and normal vision of colors
* Reachable and available during the study
* No nausea or vomit during using of a driving simulator
* Having a national insurance scheme
* Volunteer

Exclusion Criteria:

* Women
* Weight deviating of 10% of ideal weight
* Consuming moreover 5 cup of caffeine drinks
* Drinking alcohol regularly
* Acute or chronic pathologies interfering with the study
* Abnormal electrocardiogram
* Asthmatic
* Dependence present or spent in a psychotropic substance
* Presenting an anxious or depressive syndrome
* Circadian typology (Horne et Ostberg)
* Positive control in the cannabis in urines the day of the balance assessment of inclusion
* Positive control in alcohol the day of the balance assessment of inclusion
* Participating in another clinical study
* Having collected an upper total amount of compensations allowances
* Deprived of freedom further to a court or administrative order
* Risk of not observance
* Duration average of sleep of 3 nights previous every session lower than 80 % of the average duration of sleep which the volunteer thinks of needing to be in shape