cyrilzakka/clinical-trials huggingface dataset:
Asthma Intervention Research 2 (AIR2) Trial

The objective of this randomized, double blind, sham-controlled study is to demonstrate the safety and effectiveness of the Alair System in a population of subjects with severe asthma who are still symptomatic despite being managed on conventional therapy of high doses of inhaled corticosteroids and long-acting β2-agonists.

The primary efficacy endpoint will be the difference between Study groups in the change in Asthma Quality of Life Questionnaire (AQLQ) score from Baseline and the average score from the 6-, 9-, and 12-month follow-up visits.

All other outcome measures assessed at 12 months post-treatment.

This will be a multicenter, randomized, double-blind, sham-controlled study comparing the effects of treatment with the Alair System to conventional therapy of inhaled corticosteroids (ICS) and long-acting β2-agonists (LABA).

A Bayesian adaptive approach to sample size selection is used with a randomization scheme of 2:1 (two Alair Group Subjects for every one Control Group Subject).


Eligibility Criteria:
Inclusion Criteria:

* Subject is an adult between the ages of 18 to 65 years.
* Subject has asthma and is taking regular maintenance medication that includes Inhaled corticosteroid (ICS) AND long acting ß2-agonist (LABA).
* Subject has a Pre-bronchodilator Forced Expiratory Volume in one second (FEV1) of greater than or equal to 60% of predicted after medication stabilization during the Baseline Period.
* Subject has a PC20 \< 8 mg/ml per methacholine inhalation test using standardized methods. PC20 is a provocative concentration of Provocholine® (a brand of methacholine chloride) resulting in a drop of FEV1 of 20% or more from Baseline.
* Subject has at least two days of asthma symptoms during the 4-weeks of the Baseline Diary Period.
* Subject is a non-smoker for 1 year or greater (if former smoker, less than 10 pack years total smoking history).

Exclusion Criteria:

* Subject has a Post-bronchodilator FEV1 of less than 65%.
* Subject has 3 or more hospitalizations for exacerbations of asthma in the previous year; OR a history of life-threatening asthma, defined by past intubations for asthma, or ICU admission for asthma within the prior 24 months.
* Subject has a history of recurrent lower respiratory tract infections requiring antibiotics (more than 3 in the past 12 months).
* Subject has a history of recurrent oral steroid use for asthma (4 or more pulses of oral steroids in the past 12 months).
* Subject has a known sensitivity to medications required to perform bronchoscopy (such as lidocaine, atropine and benzodiazepines).
* Subject has known systemic hypersensitivity or contraindication to Methacholine chloride or other parasympathomimetic agents.
* Subject has other medical criteria.
Test to Determine the Effectiveness of Moisturizing Balm Used on Babies With Dry, Itchy Skin

The purpose of this 3 week study is to test the effectiveness of an over-the-counter (OTC) skin balm in infants and toddlers with mild to moderate dry, itchy skin.

50 infants and toddlers will be enrolled in this study to yield 40 completed subjects, 30 babies in the active treatment group and 10 babies in the positive control group.

Infants and toddlers aged 6 to 47 months inclusive will receive either a prescription or non-marketed investigational product for the treatment of eczema. Caregivers will be asked to stop use of prescription eczema treatments one week before the start of the study and during the study. Caregivers will apply study product to babies as indicated for 14 days to affected areas.

Subject caregivers will record treatment use in a daily diary and complete questionnaires. A dermatologist will examine and score the babies eczema and symptoms. Skin moisture levels will also be tested.

Eligibility Criteria:
Inclusion Criteria:

1. Able to comprehend and follow the requirements of the study (including availability on scheduled visit dates)
2. Male or female of any race or ethnicity, 6 months to 47 months of age;
3. Diagnosed as having eczema
4. Willing to stop use of all non-assigned moisturizers and/or creams for the entire duration of the study
5. Child must have bedtime/sleep issues due to their dry, itchy skin

Exclusion Criteria:

1. Use of a therapeutic (over-the-counter or prescription) body wash that contains an active ingredient for eczema
2. Participation in any clinical study within 30 days of Visit 1
3. Active infection of any type at the start of the study
4. Diagnosed as having severe eczema
5. Atopic Dermatitis requiring systemic, super-potent (Class I) or potent (Class II or III) topical corticosteroids
6. Child wakes up 3 or more times during the night
7. Child is awake more than 60 minutes during the night
8. Child sleeps for less than a total of 9 hours (during the day or night)
9. Child requires greater than 2.0 mg per day of inhaled or intranasal corticosteroids
Impact of the Lab-score on Antibiotic Prescription Rate in Children With Fever Without Source

Detecting serious bacterial infections (SBI) in children presenting to the Pediatric Emergency Department (PED) with fever without source (FWS) is a frequent diagnostic challenge. The recently described Lab-score, based on the combined determination of Procalcitonin, C-Reactive Protein (CRP) and urine dipstick results, has been shown an accurate tool for SBI prediction on retrospective cohorts. The investigators aimed to assess the usefulness of the Lab-score in safely decreasing unnecessary antibiotic prescriptions in children with FWS, and to prospectively determine the diagnostic characteristics of the Lab-score compared to other classically used SBI biomarkers (white blood cell (WBC) count, band count and CRP).


Eligibility Criteria:
Inclusion Criteria:

* children aged 7 days to 3 years old
* fever without source ≥ 100.4°F (≥ 38.0°C)

Exclusion Criteria:

* antibiotics received in the previous 48 hours
* underlying congenital or acquired immunodeficiency syndrome
* fever for more than 7 days at presentation
The Effect of Kinesio Taping on Ankle Proprioception

This study examines the effect of kinesiology tape on proprioception and postural control in subjects with sub-acute and chronic ankle sprains/strain.

The a priori hypothesis of this study is that proprioception (knee repositioning error) and balance (sway velocity and center of pressure) will improve significantly after intervention (Kinesiotape) in participants with a history of acute or chronic ankle sprains/strains.

Eligibility Criteria:
Inclusion Criteria:

* Logan student, staff, or faculty
* Between the ages of 20 and 65
* Previous history of ankle instability/sprains
* A score of 6 out of 10 questions answered yes on the Functional Ankle Instability form will qualify the candidate
Early Amniotomy Versus Delayed Amniotomy Following Foley Catheter Ripening in Nulliparous Labor Induction

Amniotomy (breaking the bag of water) is commonly used in the induction of labor. However, the timing is highly variable. The purpose of this study is to determine if first time mothers undergoing induction of labor with a Foley catheter experience a decrease in their labor time when undergoing early amniotomy (breaking the bag of water within 1 hour of Foley catheter removal) than when undergoing delayed amniotomy (breaking the bag of water at least 4 hours after Foley catheter removal). Other aims include the relationship between timing of amniotomy and cesarean section, postpartum hemorrhage, intrauterine infection, neonatal Apgar score \<7 at 5 minutes, neonatal need for intensive care.

The investigators hypothesize that induction of labor with Foley catheters followed by early amniotomy will result in a decreased duration of labor compared to those who undergo delayed amniotomy.

This randomized clinical trial of consenting nulliparous women undergoing induction of labor with a Foley catheter seeks to determine whether use of early amniotomy (defined as amniotomy within 1 hour of Foley catheter removal) improves obstetrical outcomes when compared with delayed amniotomy (defined as amniotomy at least 4 hours following Foley catheter removal).

This project will include 110 women recruited from the obstetrical service at Prentice Women's Hospital. Women will be included if they are at least 37 weeks gestation, have a singleton pregnancy, have intact membranes and are undergoing an induction of labor using a Foley catheter. Following removal of Foley catheter, women will be assessed for safety of amniotomy and if appropriate, randomized to either early amniotomy or delayed amniotomy.

Women will be randomized with equal probability to the intervention group using block randomization stratified by use of Foley catheter alone or Foley catheter-misoprostol use.

Women in the early amniotomy group will undergo amniotomy within 1 hour of Foley catheter removal. Women in the delayed amniotomy group will undergo amniotomy at least 4 hours following Foley removal. The remainder of labor management will be at the discretion of each woman's obstetric provider.

Prior to discharge from the hospital, baseline demographic and clinical data will be obtained via chart review

Eligibility Criteria:
Inclusion Criteria:

* Able to provide informed consent
* English speaking
* Women age 18 years old or greater
* Nulliparous
* Pregnant with a singleton gestation that is greater than or equal to 37 weeks
* Undergoing induction of labor with Foley catheter

Exclusion Criteria:

* Women not meeting above criteria
* Fetus in non-cephalic position
* Intrauterine fetal demise
* Fetus with major anomalies
* HIV, hepatitis B or C infection
* Planned use of oxytocin during the Foley catheter ripening
An Efficient Treatment for Posttraumatic Injury for Firefighters

The goal of this two-arm pilot randomized controlled trial is to test a behavioral intervention that integrates three evidence-based cognitive behavioral interventions (written exposure therapy; WET, cognitive behavioral therapy for insomnia; CBT-I, and cognitive behavioral therapy for nightmares; CBT-N) among firefighters. The main questions it aims to answer are:

* Is the behavioral intervention feasible, acceptable, and effective in reducing symptoms of posttraumatic stress, insomnia, and nightmares?
* What is the efficacy of efficient treatment vs. delayed treatment (2-4 week waitlist) in reducing symptoms of posttraumatic stress, insomnia, and nightmares?

We will beta test the intervention in 1-2 groups of 3-5 firefighters. Then we will randomize 50 participants to immediate or delayed (2-4 week waitlist) treatment. Consented participants will:

* Complete self-report and interview measures assessing posttraumatic stress disorder, insomnia (PTSD), and nightmares
* Attend an individual treatment orientation session
* Attend a 4-day (\~3 hours per day over 4 consecutive days) group treatment that integrates WET, CBT-I, and CBT-N
* Attend an individual booster session held approximately one week later
* Complete self-report measures before, during, and after treatment, and at a 3-month follow up assessment and a clinical interview before and after treatment to assess program efficacy.


Eligibility Criteria:
Inclusion Criteria:

* 18-65 years old
* Firefighter
* Able to speak and read English
* Clinically significant posttraumatic stress symptoms: CAPS-5 total score ≥ 25; ≥ 1 intrusion symptom; ≥ 1 avoidance symptom
* Clinically significant symptoms of insomnia: SCISD insomnia criteria are met; ISI ≥ 15
* Clinically significant symptoms of nightmare disorder: SCISD nightmare disorder criteria are met, nightmares ≥ 1 monthly.

Exclusion Criteria:

* Current suicide or homicide risk meriting crisis intervention
* Inability to speak and read English
* Inability to comprehend the baseline screening questionnaires
* Unwilling to remain abstinent from alcohol during treatment
* Serious mental health diagnosis such as bipolar disorder or psychosis.
A Study Investigating an Exercise and Education Programme for Individuals With Ankylosing Spondylitis

Ankylosing Spondylitis(AS) is a chronic, inflammatory, rheumatic disease (Khan, 2002). AS is associated with increased work disability and use of healthcare resources (Ward et al, 2008). Evidence suggests that group exercise is the most effective form of physiotherapy management for individuals with Ankylosing Spondylitis (Dagfinrud et al, 2008). To date, no research has been published in relation to short, intensive group exercise programmes.

This study aims to investigate the effects of a five day exercise and education programme for individuals with Ankylosing Spondylitis. Effects of the programme on disease activity, function and spinal mobility will be measured using using validated quantitative measures; the overall value of the programme for patients will be explored by means of semi-structured interviews.

Patients with a diagnosis of Ankylosing Spondylitis are referred to the 5-day exercise and education programme by consultant rheumatologists at the Mater Misericordiae University Hospital. All patients referred to the programmes beginning 06/24/2008 and 08/25/2008 will be invited to participate.

Participants scoring 0-6 on the Bath Ankylosing Spondylitis Metrology Index are classified as low disease severity level and are allocated to Group 1; participants with a score of 6.1-10 are classified as higher disease severity and allocated to Group 2. Group 1 has two hydrotherapy classes, a gym-based exercise class and an education session daily. Group 2 has one hydrotherapy class, a gym-based exercise class and an education session daily. Exercise sessions are 1 hour in duration and are given by staff physiotherapists. Education sessions are 1 hour in duration and are given by senior members of the rheumatology multi-disciplinary team at the Mater Misericordiae University Hospital.

Outcome will be assessed upon entry to the study (pre-intervention), at 5 days (post-intervention) and at 4 weeks (follow-up). A semi structured interview will be carried out with each participant immediately post-intervention to explore the overall value of the group programme for participants.

Eligibility Criteria:
Inclusion Criteria:

* A diagnosis of Ankylosing Spondylitis according to the modified New York criteria

Exclusion Criteria:

* Patients for whom hydrotherapy or land-exercise have been contra-indicated
* Cognitive Impairment
* Patients unwilling to give informed, written consent
Clinical Relevance of ROS (V-ros UR2 Sarcoma Virus Oncogene Homolog) Aberrations in Solid Tumours

Alterations involving the ROS (v-ros UR2 sarcoma virus oncogene homolog 1) gene such as mutations, overexpression and gene rearrangements has been implicated in carcinogenesis and has been demonstrated to be a relevant target for ALK inhibitors. While emerging reports have demonstrated the role of ROS rearrangement in non-small cell lung cancer and cholangiocarcinoma, the functional significance of ROS dysregulation in solid tumors remain largely unstudied. The investigators aims are: (1) To characterize the frequency of ROS gene fusion, ROS protein overexpression and ROS gene mutations in cell lines and tumors from patients with hepatocellular carcinoma, colorectal, gastric, breast, ovarian, cholangiocarcinoma and non-small cell lung cancer, (2) To identify novel ROS gene variants in human solid tumors harboring ROS aberrations using next generation sequencing (NGS), (3) To determine the functional relevance of novel ROS gene variants identified with NGS, (4) To characterize the sensitivity of cells with functionally relevant ROS aberrations using ROS tyrosine kinase inhibitors. ROS fusions and protein overexpression will be screened in a panel of cell lines and primary tumors using Fluorescence In-situ Hybridization and immunohistochemistry respectively. Targeted next-generation sequencing will be applied to identify ROS variants in matching cancer types demonstrating high levels of gene fusion and protein overexpression. Functional characterization of novel ROS variants will be performed by silencing (shRNA) and overexpressing candidate cell lines with the respective ROS mutations/fusions, and evaluating their effects on biological functions including cell proliferation, migration, invasion and apoptosis, as well as sensitivity against ROS/ALK inhibitors. The investigators anticipate findings from this study will improve the investigators understanding of aberrant ROS signaling in an expanded group of cancer types, and potentially identifying a larger group of cancer patients that will benefit from ROS targeted therapy.

Further insight of the role of ROS receptor tyrosine kinase will confirm it as a therapeutic target in human solid tumors and hence expand the indication of crizotinib and other dual ALK/ ROS inhibitors. Furthermore, given the rarity of ROS fusion receptor tyrosine kinase in reported cancers, defining the epidemiology of ROS aberrations in other unreported cancers harboring ROS pathway activation is essential to properly design future clinical trials of ROS inhibitors. The validation of ROS receptor tyrosine kinase will also provide a new therapeutic target in the treatment of cancer and expand the role of novel targeted agents. Findings from this study will further the investigators knowledge on the oncogenic functions of the ROS and the application of ROS inhibitors in an extended group of solid tumors.


Eligibility Criteria:
Inclusion Criteria:

- Patients with cancer
Optimal Training Frequency for Attainment and Maintenance of High-quality CPR on a High-fidelity Manikin

Objectives: The primary objective is to determine the least frequent CPR training interval associated with continued performance of guideline-compliant CPR. The secondary objective is to determine whether certain physical characteristics, such as age, gender, exercise tolerance, height, and weight may be able to identify HCPs at high risk of being unable to perform high-quality CPR.

Design: Randomized trial to compare the effect of different training frequencies on long-term CPR performance.

Participants and setting: Nurses in all adult departments at Health Sciences North. Subjects will be randomly assigned to a group that undertakes short CPR assessment and training sessions either 1) every month, 2) every 3 months, 3) every 6 months, or 4) every 12 months (control group) over the course of a twelve-month period.

Analysis: The proportion of nurses in each group that is able to perform "excellent CPR" at the twelve-month time point will be determined. Excellent CPR is defined as a two-minute CPR session where 90% of compressions are performed with correct depth (50-60 mm), 90% with correct rate (100-120 /min), and 90% with full chest recoil. A subgroup analysis will also be performed where the demographic data of individuals who are unable to perform excellent CPR at the twelve-month time point regardless of intervention group are compared against those who are successful.

Conclusion: The results of our study will help determine the longest CPR training interval associated with maintenance of high-quality CPR skills to minimize training sessions required and decrease associated costs. The results will also generate hypotheses for future study about optimizing role assignments and team performance in resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Practicing nurses from multiple clinical environments (operating room, intensive care unit, emergency room, medical and surgical wards) at Health Sciences North.

Exclusion Criteria:

* Refusal to participate
Clinical Trial of Aesculus Hippocastanum and Associations Versus Diosmina and Hesperidina in Chronic Venous Insuficiency

To demonstrate the clinical non-inferiority of efficacy between Aesculus hippocastanum, Polygonum acre, Smilax Pepyracea, Rutin and Diosmin 450mg and Hesperidin 50mg tablets in the improvement of lower limb symptoms assessed by means of a 100mm visual scale (VAS) over 3 months among adult patients presenting with chronic venous insufficiency of the lower limbs.

Phlebotonics represent a heterogeneous group of therapeutic products of natural or synthetic origin that exhibit effects on edema and/or symptoms related to chronic venous diseaseThis class of drugs is effective in improving the symptoms of chronic venous insufficiency and in cases of hemorrhoids and for this reason they have become an established component of the therapeutic arsenal for all phases of these diseases Phlebotomics are classified into four categories: benzopyrones, saponins, other plant extracts, and synthetic drugs

Eligibility Criteria:
Inclusion Criteria:

1. Patient presenting CEAP classification from grade C0 to C3 in the evaluation of venous disease of the lower limbs
2. Clinical symptoms of chronic venous insufficiency of the lower limbs, defined by the 100mm visual scale performed by the patient between 20mm and 60mm in the most symptomatic lower limb.
3. For female patients of reproductive age, not pregnant or breastfeeding, using reliable contraceptives.
4. Patient read, understood, signed and dated the free and informed consent form

Exclusion Criteria:

1. Treatment with compression stockings within 2 months of study inclusion date
2. Treatment with venotonics within 2 months of the date of inclusion in the study
3. Women of reproductive age who are pregnant or breastfeeding, or who do not wish to use contraception during the study period.
4. Known allergy or hypersensitivity to any component of the study drug
5. Known significant laboratory abnormality
6. CEAP Grade Assessment of level 4, 5, or 6.
7. Patient with venous disease requiring intravenous chemical surgery/sclerotherapy
8. Patient presenting with a painful pathology in addition to venous pain in the lower limbs 9. Patient with a history of thrombosis or thromboembolic disease within 6 months of the date of inclusion in the study

10. Patient with a change in general condition that is incompatible with his/her participation in the study 11. Patient who wishes to become pregnant within 6 months
Upper Limb Ergometer on Pulmonary Function Among Patients With Spinal Cord Injury.

Randomized Control Trial, To determine the effects of arm ergometer exercise on pulmonary function of Spinal Cord Injury.

The spinal cord is a tubular structure contained nervous tissue. This acts as a transmission channel of nerve signals within the brain and spinal cord. It contains grey and white matter. The grey matter consists of cell bodies of different sensory and motor neurons and white matter consists of oriented spinal tracts.

By 2007, a prospective observational study had been conducted after a disaster occurred in Pakistan which was the most cataclysmic natural disaster in country's history as a result 73000 people were lost their lives and 126000 were harmed. There was no Spinal Cord Injury (SCI) registry existed in the country but according to different estimates 650-750 had been effected of SCI.

In United States SCI incidence mainly due to higher percentage of violence-related SCIs (18%)which is higher compared to the western Europe (8%) Australia (2%). In Pakistan the most common traumatic cause of SCI was falling from different cause followed by road traffic accident (RAT) (25.2%) and functional aerobic impairment (FAI) (8.4%). The way that SCI is associated with fantastic expenses and human sufferings , yet careful statistics of SCI are not accessible in dominant of developing countries including Pakistan.

Total lung capacities become abnormal in chronic spinal cord injury patients. Changes in chest wall compliance and decreased respiratory muscle strength leads to abnormal changes in overall lung capacities.

Eligibility Criteria:
Inclusion Criteria:

* SCI at level of upper and lower thoracic spine

Exclusion Criteria:

* Cardiovascular diseases
* Active inflammation or infection going in body
* Malignancies
* Those Individuals with have psychiatric disorders
* Any other neurological condition related to brain (stroke, parkinson's etc)
* Pressure ulcers (grade 3 and grade 4)