cyrilzakka/clinical-trials huggingface dataset:
Noninvasive Positive Airway Pressure in the Pediatric Emergency Department for the Treatment of Acute Asthma Exacerbations

Previous investigations and anecdotal experience have shown safety and utility of Noninvasive Positive Pressure Ventilation/Bilevel Positive Airway Pressure (NIPPV/BiPAP) for the treatment of asthma in children. If NIPPV/BiPAP can be shown to have a beneficial effect in children with respiratory insufficiency, emergency department and ICU stays may be shortened, and the need for more invasive and dangerous airway procedures may be decreased. This would result in a change in the standard of care for asthma treatment in emergency departments. The investigators hypothesis is that the use of this new NIPPV, in conjunction with current standard of care therapies, in acute moderate to severe asthma exacerbations will lead to a more rapid improvement in patient ventilation, faster resolution of respiratory distress, and overall improved secondary outcomes.


Eligibility Criteria:
Inclusion Criteria:

* 2-18 years old
* For subjects 3 years and older, a known history of asthma as diagnosed by the PCP or per the Vanderbilt problem list
* For children ages 2-3 years, four or more episodes of wheezing in the past year that lasted more than 1 day and affected sleep AND one of the following: parental history of asthma, a physician diagnosis of atopic dermatitis, or evidence of sensitization to aeroallergens
* Acute asthma exacerbation
* Pediatric Asthma Score (PAS) ≥ 8
* Parents willing and able to sign consent
* Children over the age of 6 willing to provide assent

Exclusion Criteria:

* History of congenital heart disease, chronic respiratory disease including bronchopulmonary dysplasia, cystic fibrosis, pulmonary hypertension or any chronic lung disease other than asthma
* History of sickle cell disease
* Recently diagnosed pneumonia
* Current tracheostomy, on home ventilator or home oxygen requirement
* Recent diabetic ketoacidosis
* Requiring immediate intubation
* Weight less than 5 kilograms
* Any contraindication to BiPAP use including altered mental status, recent bowel surgery, intractable vomiting, inability to protect airway
* A history of prematurity of ≤ 30 weeks gestation
A Study Using Botulinum Toxin Type A in Adolescents With Axillary Hyperhidrosis

A study using Botulinum Toxin Type A in adolescents with axillary hyperhidrosis.


Eligibility Criteria:
Inclusion Criteria:

* Marked axillary hyperhidrosis

Exclusion Criteria:

* Previous use of botulinum toxin for hyperhidrosis
Comparison of Kinesio Taping and Dry Needling in Grade 1, 2 Knee Osteoarthritis

This study's aim was:

- To determine the effects of kinesio taping and dry needling on pain, ROMs, functional mobility, and quality of life in knee OA patients.

This was a randomized clinical trial in which Grade 1, 2 Knee Osteoarthritis patients were randomized into two groups: Group-A and Group-B. Group-A participants received Kinesio taping while Group-B participants received dry needling as an adjunct to the conventional physical therapy treatment. The intervention was carried out for four weeks with frequency of two sessions per week. Outcome measures were assessed at baseline, after two weeks, and after 4 weeks, using Visual Analog Scale (VAS), Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Knee Range of Motion (ROM), and SF-12 Quality of Life Questionnaire.

Eligibility Criteria:
Inclusion Criteria:

* Clinically diagnosed patients of grade 1, 2 knee OA (Kallgren and Lawrence).
* Pain and/or tenderness around knee joint
* Knee OA patients with tightness in Quadriceps, Hamstrings, and Iliotibial band.
* Patients with pain of \>4 on VAS.

Exclusion Criteria:

* Patients who had received Intra-articular Steroid injections in knee joints.
* Patients who had suffered a traumatic injury to knee joint within past 6 months prior to this study.
* Patients with any surgical intervention to the knee joints.
* Patients with peripheral vascular disease.
* Patients with diagnosed tumors, malignancies, infection associated with knee joint.
* Patients with lower limb metallic implants.
Treatment of the Metabolic Syndrome in an Interdisciplinary Obesity Clinic: a Randomized Controlled Study

This study is a randomized, controlled and opened trial designed to compare the effects of an interdisciplinary moderate-intensity lifestyle modification program vs. conventional treatment by primary care physicians.

We want to show the benefits of coherent interdisciplinary care in the obesity clinic of CHUS (Centre Hospitalier Universitaire de Sherbrooke) in comparison to the conventional treatment in order to:

* Improve subjects' characteristic features of metabolic syndrome: weight, waist circumference, fatty mass, plasma lipid profile, blood pressure, fasting glycaemia, and HbA1c;
* Improve our patients' nutritive practices;
* Decrease our patients' sedentary lifestyle;
* Improve our patients' motivation to lose weight, and to improve their quality of life; We also wish to define predictors of answer in order to better select the patients if necessary, and evaluate the costs incurred by the health system.

Eligible participants recruited from patients, referred through the obesity clinic were separated into two groups.

The interdisciplinary treatment group received interventions at our clinic for 6 months.. The intervention included a visit every 6 weeks including a nursing consultation (listening, psychological support, anthropometric measurements and blood pressure), an endocrinologist consultation, a nutritionist consultation (initial evaluation of food intake and counselling), a psychologist consultation if needed, an interactive group information session (to discuss the following: diet, psychological aspects associated with obesity, physical education, complications and pharmacological treatments of obesity), and a questionnaire on the individual costs of their visit.

A control group was monitored during this 6 months by their family physician, as per usual.

A biological assessment, questionnaires, and tests will be carried out in beginning and end of program: the questionnaires are to evaluate the physical activity (Sallis, Canada fitness survey); the quality of life (IWQOL-Lite, SF-36); the motivation (analogical visual Scales); knowledge (pretest and post-test); and costs. Tests to assess physical activity (6-minute walk test and accelerometer) will also be administered.

After the first 6 months, both groups were followed at the obesity clinic for another 12 months.

Eligibility Criteria:
Criteria Inclusion:

* referred to the obesity clinic by a medical doctor;
* BMI \> 27 kg/m²; (Body Mass Index)
* metabolic associated syndrome according to the definition of the NCEP-ATP III
* be able to give an inform consent

Criteria Exclusion:

* Impossibility to be present at the visits
* Physical/motor incapacity (or other) making one unable and insecure to walk at a moderate to rapid speed for 6 min and more
* Use of an anti-obesity treatment the last 3 months
* Bariatric Surgery in the past
* Planned Pregnancy
* Pacemaker
Safety Study of SBRT and Docetaxel for Locally Recurrent or Second Primary Squamous Cell Carcinoma of the Head and Neck

The purpose of this research study is to test the safety of a chemotherapy drug called docetaxel and focused radiation therapy (SBRT) and see what effects (good and bad) it has on recurrent head and neck cancer that is not surgically removable.


Eligibility Criteria:
Inclusion Criteria:

* Recurrent or second primary squamous cell head and neck cancer
* Defined area of recurrence on imaging
* Previous head and neck radiation (RT) to \>/= 50 Gy
* Performance status score 0-1
* Time interval from previous RT \>/= 9 months
* Volume of disease appropriate for protocol treatment
* Minimum estimated survival of \>/= 3 months
* Age \>/= 18
* Adequate labs

Exclusion Criteria:

* Primary tumors of the salivary gland
* Original pathology report and radiation therapy records not available
* Prior spinal cord dose \> 45 Gy
* Surgery or chemotherapy within 4 weeks
* Prior invasive malignancy (except non-melanomatous skin cancer) unless disease free for a minimum of 3 years; noninvasive cancers are permitted
Short Versus Long Post-Operative Restrictions Following Lumbar Discectomy

Post-operative restrictions following lumbar discectomy is a controversial topic. While the most widely accepted protocol restricts bending, lifting, and twisting for four to six weeks following discectomy, a number of studies support an early return to full activity without restriction. Since the goal of discectomy is to promptly provide pain relief and a return to a fully active lifestyle, perhaps post-operative restrictions are more hindering than beneficial.

Hypothesis: Post-operative restrictions following lumbar discectomy do not influence reherniation rate.

Specific Aim 1: To compare the reherniation rates between the 6-weeks of restriction and the 2-weeks of restriction groups.

Specific Aim 2: To determine the return to full activity and return to work dates of both the 6-weeks of restriction and 2-weeks of restriction groups.

Specific Aim 3: To assess the health outcomes of both the 6-weeks of restriction and 2-weeks of restriction groups.

Upon enrollment, subjects will be randomized to the "6-weeks of restriction" or "2-weeks of restriction" group. Subjects will also be asked to provide/complete:

* demographical information
* VAS back and leg score
* Modified Oswestry questionnaire

All of the surgeries will be performed using a so-called limited discectomy in which the herniated disc fragment is removed without an aggressive disc space curettage. Prior to surgery, the subjects' discs will be classified by the Primary Investigator and Site Responsible Investigator on a T-2 weighted MRI according to the Carragee Disc Herniation Classification system.

The discs will be reassessed intraoperatively by the surgeon to confirm the assigned classification. In addition, a radiologist will review a random sampling set of discs on T-2 weighted MRI to eliminate bias and validate the classifications.

Subjects will be followed for a 2 year time period with study visits at 2 weeks, 6 weeks, 3 months, 1 year, and 2 years. At every follow-up visit, the following will be completed and/or documented:

* A reherniation (any clinical symptoms of a reherniation will be verified and documented by MRI)
* Return to full activity and/or work (date)
* VAS back and leg score
* Modified Oswestry questionnaire

Eligibility Criteria:
Inclusion Criteria:

* 18 years of age or older
* English speaking
* single level lumbar disc herniation
* surgical candidate
* no previous lumbar surgery
* primary radicular pain

Exclusion Criteria:

* Less than 18 years of age
* Non-English speaking
* Multi-level lumbar disc herniation
* Disc reherniation
* Previous lumbar surgery
* Primary low back pain
Everolimus in Treating Patients With Progressive or Recurrent, Unresectable, or Metastatic Thyroid Cancer

RATIONALE: Everolimus may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth and by blocking blood flow to the tumor.

PURPOSE: This phase II trial is studying how well everolimus works in treating patients with progressive or recurrent, unresectable, or metastatic thyroid cancer.

OBJECTIVES:

Primary

* To determine the efficacy of everolimus in patients with progressive or recurrent, unresectable, or metastatic differentiated thyroid carcinoma.

Secondary

* To determine maximum percentage of tumor reduction in these patients.
* To describe activity time to event endpoints.
* To assess toxicity.
* To determine evolution of serum thyroglobulin.
* To perform explorative pharmacogenomic, pharmacokinetic, and translational studies. (exploratory)
* To investigate efficacy of everolimus in patients with progressive or recurrent, unresectable or metastatic disease of undifferentiated (anaplastic) or medullary thyroid cancer.

OUTLINE: Patients receive oral everolimus once daily on days 1-28. Treatment repeats every 28 days in the absence of disease progression or unacceptable toxicity.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of thyroid cancer meeting ≥ 1 of the following criteria:

  * Progressive or recurrent disease
  * Metastatic disease
  * Unresectable disease
* Meeting any of the following thyroid cancer subtypes:

  * Differentiated thyroid cancer (i.e., papillary, follicular, or Hurthle cell disease) that is radio-iodine refractory
  * Undifferentiated thyroid cancer (i.e., anaplastic disease)
  * Medullary thyroid cancer
* Must have received prior everolimus or other mTOR inhibitor therapy
* Patients with history of brain metastasis who are neurologically stable following definitive radiation and/or surgery and do not require corticosteroids allowed

PATIENT CHARACTERISTICS:

* Karnofsky performance score 70-100%
* ANC ≥ 1,500/mm\^³
* Platelet count ≥ 100,000/mm³
* Hemoglobin ≥ 5.6 mmol/L
* Serum bilirubin ≤ 1.5 times upper limit of normal (ULN)
* ALT and AST ≤ 2.5 times ULN (≤ 5 times ULN for known liver metastases)
* Serum creatinine ≤ 2 times ULN
* Negative pregnancy test
* No other malignancy, except nonmelanoma skin cancer, carcinoma in situ of the cervix, or a malignancy diagnosed and with no current evidence of malignancy within the past 2 years

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Assessment of Home Tonometry in Glaucoma

Worldwide, glaucoma is the most common cause of irreversible blindness. The major risk factor is raised pressure within the eye (intraocular pressure, IOP). IOP is typically measured using Goldman applanation tonometry (GAT). This involves instilling anaesthetic eye drops and using a probe to contact the cornea and obtain a pressure measurement. A major disadvantage of GAT is that only limited numbers of pressure measurements can be obtained, whereas IOP is known to vary throughout the day and in ¾ of people is highest during the night. The result is that clinicians have poor understanding of patient's 24 hour IOPs and the effect that this might have on their glaucoma. This is a serious limitation as the treatment of glaucoma depends on lowering IOP.

Recently a new device has become available, designed specifically for home IOP monitoring. The iCare HOME tonometer is a CE marked commercial device (http://www.icaretonometer.com/products/icare-home-tonometer/) that can be used to gain insight into 24-hour IOP fluctuations. The investigators wish to determine the feasibility of home IOP monitoring using this device. The iCare HOME tonometer depends on the patient performing self-tonometry. Testing one's own IOP may be technically difficult and it is likely that large numbers of patients will struggle with this.


Eligibility Criteria:
Inclusion Criteria:

* Glaucoma
* At least 4 previous visual field tests (to enable rate of change to be calculated).
* Age 16 years and above
* Age less than 100

Exclusion Criteria:

* Corneal disease (potentially affects pressure measurements)
* Neovascular glaucoma
* Uveitis
* Secondary glaucomas
* Inability to give informed consent.
* Less than 16 years of age.
* Pregnancy.
* Unable to hold iCare HOME® tonometer due to upper limb weakness or disability.
Use of Roflumilast to Prevent Exacerbations in Fibrotic Sarcoidosis Patients (REFS)

Pulmonary sarcoidosis patients with fibrosis often develop recurrent episodes of bronchitis. These can lead to worsening of disease for both the short and long term.

Roflumilast has been shown to reduce the number of acute bronchitis episodes in patients with COPD.

Drugs similar to Roflumilast have been shown to help sarcoidosis. The current study is to determine if Roflumilast will reduce number of episodes of bronchitis and help fibrotic sarcoidosis.

This will be a multicenter, double blind, placebo controlled study. Patients would be randomized 1:1 to receive either roflumilast 500 mcg per day or placebo added to their current treatment regimen for twelve months.

Eligibility Criteria:
Inclusion Criteria:

1. Patients with sarcoidosis as defined by the American Thoracic Society criteria
2. Patients with an FEV1/FVC ratio of less than 80%
3. Patients with fibrosis on chest x-ray and/or high resolution CT scan.
4. Patients have had at least two exacerbations of their sarcoidosis in the prior year. An exacerbation is defined as an acute event requiring increase of prednisone with or without use of antibiotics.
5. Patients must be on a stable dose of corticosteroids and other agents for their sarcoidosis at least 4 weeks prior to first visit.
6. For patients on prednisone alone, the dose has to be the equivalent of 5 mg prednisone a day. For those on other immunosuppressants, they can be on any dose of prednisone.
7. Patients must be between ages of 18 and 70 years of age.
8. Willing to take prednisone at increased dosage for exacerbations of their sarcoidosis.
9. Patients must be able to provide written informed consent to participate in the study.

Exclusion Criteria:

1. Patients with known hypersensitivity to theophylline or pentoxifylline will not be eligible. Patients with dose dependent nausea from these drugs may still participate in the trial.
2. Patients will not be able to take theophylline or pentoxifylline during the time of the study. They will be allowed to take drugs for sarcoidosis including prednisone, methotrexate, azathioprine, leflunomide, hydroxychloroquine, thalidomide, infliximab, adalimumab, and rituximab.
3. Patients with serum creatinine of greater than 3 mg/dL
4. Patients with moderate or severe liver disease as defined Child Pugh class 3 or 4.
5. Patients with unstable cardiac disease
6. Patients with non cutaneous malignancy treated in the past two years.
7. Patients unable to complete the questionnaires and six minute walks detailed in the study.Women of child bearing potential unable to use adequate birth control as determined by the investigator.
Qualitative Study on Osteoporosis Representation and Management in the General Population and in General Practitioners.

Osteoporosis (OP) and subsequent fractures (OP fractures) are a source of morbidity and high mortality in the elderly. Despite numerous programs aiming at improving OP care, the prevention, diagnostic and treatment remain suboptimal. Barriers to a better care are multiple, both in the general and at-risk population, and in medical practitioners. Since they do not perceive their susceptibility to OP, people do not see the benefit of prevention. In addition, physicians do not give sufficient importance to OP prevention and care, despite the existence of guidelines.

The investigators implemented a qualitative study to explore the knowledge and representations regarding osteoporosis in the general and at-risk population and in doctors in Rhône-Alpes Region, France, using focus groups with women and men and semi-structured face-to-face interviews with general practitioners. Understanding barriers to osteoporosis care in patients and general practitioners will help to set up effective strategies to improve prevention and treatment.


Eligibility Criteria:
Inclusion Criteria:

* group 1: women aged 50 to 85 years with a history of fragility fracture or an osteoporosis diagnostic
* group 2: women aged 50 to 85 years without a history of fragility fracture or an osteoporosis diagnostic
* group 3: men aged 60 to 85 years with a history of fragility fracture or an osteoporosis diagnostic
* group 4: men aged 60 to 85 years without a history of fragility fracture or an osteoporosis diagnostic
* group 5: general practitioners in Region Rhône-Alpes, France
* who signed the consent form

Exclusion Criteria:

* no signed consent
* legal disability
* difficulty in understanding French
* psychiatric disorder
Initial Manifestations of Congestive Heart Failure in Patients With NSTEACS

Acute heart failure (HF) is a common complication of acute coronary syndrome (ACS) associated with poor prognosis. Diagnosis of congestive HF in patients with initial, non-severe symptoms and signs may be challenging and early stages of this complication may be missed. To assess severity of HF in patients with ACS Killip classification is widely used but it does not take into account mild manifestations of HF. Thus, patients without rales in the lungs and/or S3 will be labelled as Killip class 1. The aim of this study is to determine the frequency, risk factors, abilities for early diagnosis using routine medical evaluation and clinical significance of subclinical and mildly symptomatic congestive HF in patients with ACS without persistent ST-segment elevation (NSTEACS).

The study will include 200 patients with NSTEACS without history of severe HF and overt signs of congestion at presentation. Presence and severity of dyspnea (according to Likert ans Visual analog scales), physical signs of heart failure (respiratory rate, distention of jugular veins, S3), peripheral oxygen saturation by pulse oximetry, heart rate and signs of ischemia on ECG, signs of congestion according to lung and vena cava inferior ultrasound and chest X-Ray/CT as well as levels of NT-proBNP, hsTn, CRP and FABP at presentation will be evaluated. Presence and severity of dyspnea, physical signs of heart failure, oxygen saturation, heart rate and signs of ischemia on ECG, lung and vena cava inferior ultrasound will be re-assessed after 6, 12 and 24 hours. During hospitalization occurrence or worsening of clinical HF. Clinical events will be followed up to 12 months after hospitalization.


Eligibility Criteria:
Inclusion Criteria:

* Patients hospitalized to the cardiac intensive care unit with ACS without persistent ST-segment elevation
* Signed informed consent

Exclusion Criteria:

* ACS with persistent ST-segment elevation
* High probability of absence of ACS
* Congestive rales in the base of lungs, cardiac asthma, pulmonary edema, cardiogenic shock, obvious edema, anasarca
* History of severe chronic heart failure (III-IV NYHA class, obvious edema, anasarca)
* Continuous use of loop diuretics