Kornimate/medical-research-clean huggingface dataset:
the treeat study- can early introduction of tree nuts prevent tree nut allergy in infants with peanut allergy

Conditions: Food Allergy in Infants; Nut Allergy

Summary: early and regular ingestion of the common allergens, peanut and egg has been shown to be an effective allergy prevention strategy. it is not clear whether this is also true of tree nut allergy. current practice in many australian allergy clinics for children with peanut allergy (high risk of tree nut allergy), is to advise families to introduce each individual tree nut into their child's diet via a cautious home introduction protocol without prior allergy testing (screening). the safety and effectiveness of an early and regular ingestion strategy for the prevention of tree nut allergy has not been formally evaluated and it is known that around a third of children with peanut allergy develop one or more other nut allergies. this trial is a 2-armed, open-label, randomized, controlled trial (rct) to assess the safety and efficacy of a supervised hospital based multi-tree nut (almond, cashew, hazelnut and walnut) oral food challenge (ofc) + then home introduction of the remaining tree nuts versus standard care (home introduction of all 8 tree nuts) in infants with peanut allergy to reduce the risk of developing tree nut allergy.


Eligibility criteria:
inclusion criteria: infants aged greater than 4 months and less than 11 months of age diagnosed with ige-mediated peanut allergy in conjunction with a positive spt (≥3mm) or sige (specific immunoglobulin e) (\>0.35 ku/l) exclusion criteria: * any history of severe food induced anaphylaxis. defined as reaction requiring 2 doses of intramuscular (im) adrenaline. * pre-existing tree nut allergy (parent-reported). * any tree nut already tolerated (ingestion on \>3 occasions without reaction of around 1 teaspoon) * spt or sige performed to any tree nuts * not commenced or unable to eat solid food * prescribed beta-blocker medication

Keywords: food allergy nut allergy
follow-up of the patients included in the exesas study

Conditions: Sleep Apnea Syndromes; Sleep Apnea, Obstructives

Summary: sleep apnoea affects more than 20% of people over 65 years and is largely underdiagnosed. it does multiply tenfold the occurrence of vascular events, particularly stroke. while continuous positive airway pressure (cpap) is currently the gold standard treatment to prevent cerebrovascular and cardiovascular events, with a major clinical benefit, long term adherence to cpap is a significant problem and search for alternative treatment is essential.

in the previous exesas study (nct02463890) the investigators compare evolution of apnea hypopnea index (ahi) in an exercise trained group performed through in a national based non-profit organization (fédération française d'éducation physique et de gymnastique volontaire (ffepgv)) using a medical established program (neurogyv) during nine months against a control group receiving only standard dietetic and physical activity counseling. the first partial observations of the study exesas seem encouraging in the term of 3 months of training. however, in the longer term, there is not a coverage in the treatment of the moderate sleep apnea: obstructive syndrome (saos). thus they can logically expect that the possible therapeutic effect of the exercise is not maintained in the long term after the stop of the training. this nex study suggests studying the profit of the exercise on sleep apneas for the patients who were initially in the control group in the exesas study and to observe if the preservation of a regular physical activity for the group which was trained in exesas study is associated with a preservation of the ahi after the additional year of follow-up without additional intervention

Eligibility criteria:
inclusion criteria: * included in the previous exesas study * signature of consent exclusion criteria: * patients being already treated for sleep apnea or clinical status (cardiovascular comorbidities) justifying an immediate initiation of cpap * daytime sleepiness (ess score \> 10) * known respiratory or heart disease (or discovering during stress test) contraindicated exercise training * patients with parkinson's disease * ahi \> 30

Keywords: sleep apnea syndromes sleep apnea, obstructives training
effectiveness and implementation of a mental health intervention for asd

Conditions: Autism Spectrum Disorder

Summary: the purpose of this study is to test the effectiveness of training community mental health therapists to deliver a mental health intervention for asd ("aim hi") and study the process of implementing aim hi in community mental health programs.

this study is a randomized controlled effectiveness trial of aim hi ("an individualized mental health intervention for asd"), an intervention designed specifically for implementation in community mental health clinics, to reduce problem behavior among school-age children with autism spectrum disorders (asd). although the individual components of aim hi are well-established evidence-based practice strategies and pilot study data indicate that child behavior problems decrease when their community mental health therapists deliver aim hi, the effectiveness of the protocol has not been established. therefore, the primary aims are to test the impact of training community therapists in aim hi on child and family outcomes and determine how child/ family characteristics and level of therapist fidelity moderate treatment effects. the secondary aim is to collect initial data on implementation outcomes and conduct exploratory analyses to identify barriers and facilitators of aim hi implementation (e.g., intervention, organization, provider characteristics). this study has the potential to make a significant impact by building local capacity to serve school-age children with asd in routine service settings, and advancing the science on the effectiveness of packaging evidence-based practices (ebps) for specific services settings. it will also produce generalizable knowledge about implementation that can be applied for this population/ setting.

Eligibility criteria:
inclusion criteria for therapists 1. employed as staff or a trainee at participating clinic (publicly-funded mental health program) 2. employed for at least the next 7 months (i.e., practicum or internship not ending in next 7 months). 3. has an eligible client on current caseload (see below). inclusion criteria for child/ parent participants 1. child age 5-13 years. 2. has a current asd diagnosis on record. 3. meets criteria for asd on the autism diagnostic observation schedule (ados) or exhibits other clinical indicators of asd 4. english or spanish speaking. exclusion criteria for child/ parent participants 1. child does not present with challenging behaviors. 2. child does not meet criteria for asd on the ados or exhibit other clinical indicators of asd
upper extremity and muscle oxygenation

Conditions: Near-infrared Spectroscopy; Muscle Oxygenation

Summary: the aim of this study was to measure the acute change in oxygen saturation of skeletal muscle during resistance exercise in the upper extremity using near-infrared spectroscopy.

our study aims to determine the acute oxygen response in the upper extremity muscles against a resistance exercise fatigue protocol, in order to demonstrate the effect of muscle oxygenation levels on the occurrence of symptoms such as fatigue in upper extremity use, and to provide reference information for the development of exercise programs. it is known that resistance exercise increases resting energy expenditure and promotes fat oxidation for weight loss. changes in cardiopulmonary function that occur in chronic diseases reduce oxygen uptake and decrease energy production, leading to increased fatigue. resistance exercises in chronic diseases can regulate an individual's energy production capacity. the main objective of our study is to investigate the effect of muscle oxygenation levels on the occurrence of symptoms such as fatigue by determining the oxygen response in the upper extremity muscles based on a resistance exercise protocol.

Eligibility criteria:
inclusion criteria: * volunteering to participate in the study * being over 18 years old * having a body mass index (bmi) value between 23-30 kg/m2 * absence of comorbid disease of the orthopedic, neurological, cardiopulmonery system exclusion criteria: * smoking / alcohol use * presence of orthopedic disease effecting the upper extremity or previous surgery * presence of cardiopulmonery disease that prevents exercise * participants who performed resistance exercise regulary for more than 6 months

Keywords: near-infrared spectroscopy resistance exercise exercise intensity muscle oxygenation muscle activation
an observational study of avastin (bevacizumab) in patients with metastatic breast cancer

Conditions: Breast Cancer

Summary: this observational study will assess the median time of treatment duration and the safety of avastin (bevacizumab) as first line treatment in patients with metastatic breast cancer. data will be collected for approximately 24 months.


Eligibility criteria:
inclusion criteria: * patients with metastatic breast cancer in first line treatment who have completed treatment with avastin exclusion criteria: * patients not willing or unable to signed written consent form
transcranial direct current stimulation for chronic pain relief

Conditions: Chrronic Pain Patients

Summary: in the present study, the investigators intend to investigate whether anodal transcranial direct current stimulation (tdcs) may be effective in reducing pain in chronic pain patients.

tdcs is a noninvasive brain stimulation technique that utilizes low amplitude direct currents applied via scalp electrodes to modulate the level of cortical excitability.several studies have demonstrated that tdcs applied over the sensory-motor cortex has been able to decrease pain sensation and to increase pain threshold in healthy subjects and in chronic pain patients. the aim of this study was to test whether daily sessions of anodal tdcs repeated for 5 consecutive days may be effective in reducing pain in a large number of chronic pain patients. patients will receive sham tdcs or real tdcs in a 5-day period of treatment in a randomized, sham controlled study. the participants will be divided to 2 groups of 50 each. one group will receive 5 days period of 20 min 2ma tdcs over the lt m1 and the other will receive sham stimulation. x week later the groups will switch to the other arm. pain will be measured using visual analog scale (vas) for pain and the short form mcgill questionnaire (sf-mpq). disability will be measured using the ( pain disability index (pdi) of life-54 scale (msqol-54). depressive symptoms and anxiety will also be evaluated using the center for epidemiological studies-depression scale and the state-trait anxiety inventory (stai). cognitive function will be mesured using minimental test. evaluations will be performed at baseline, immediately after the end of treatment, and once a week during a 3-week follow-up period.

Eligibility criteria:
inclusion criteria: * over 18 * chronic pain patients vas \> 4 exclusion criteria: * pregnancy * scalp lacerations * history of seizures * metal implants in the head * heart pace maker
clinical use of evusheld as pre-exposure prophylaxis in real-world setting in gulf cooperation council countries

Conditions: COVID-19

Summary: study on clinical use of evusheld (azd7442) as pre-exposure prophylaxis in the real-world setting - a multi-centre observational prospective study to determine the utilization and clinical outcomes of evusheld in gulf cooperation council countries

study on clinical use of evusheld (azd7442) as pre-exposure prophylaxis in the real-world setting observational prospective study to determine the utilization and clinical outcomes of evusheld in gcc. this will be a multi-country, multi-centre, single-arm, observational, prospective study using primary data collection to describe the demographic and clinical characteristics of patients who received the first dose of azd7442 for the prevention of sars-cov-2 infection causing symptomatic covid-19 illness. the study will be conducted in the hospital/centers that are authorized to administer azd7442, agree to participate in the study, and wherein investigators have access to all medical records (electronic/paper) for individual patients. the physicians at the hospital/centers will make a decision to administer azd7442 to patients according to the local regulations (including the prescribing information) and such a decision to use azd7442 is independent of the study.

Eligibility criteria:
inclusion criteria: * individuals receiving their first dose of azd7442 for the prevention of sars-cov-2 infection within the 30 days prior to study enrolment. * the ability or willingness to sign informed consent/assent forms exclusion criteria: * patients currently participating in interventional clinical trials of sars-cov-2 vaccines, other sars-cov-2 prophylactic interventions, or covid-19 treatments. * patients with an ongoing covid-19 infection at the time of azd7442 administration as judged by the study physician.

Keywords: covid-19 sars-cov-2 azd7442 evusheld real-world setting
trigger point injection in reducing pain following total knee arthroplasty

Conditions: Trigger Point Pain, Myofascial

Summary: this study will evaluate the ability of trigger point injections completed immediately following a total knee arthroplasty decrease pain scores and opioid use compared to sham injections. given the current state of opioid dependency in the united states there needs to be a more focused attempt at treating post-operative pain without use of opioids. given the manipulation of soft tissue during a total knee arthroplasty there seems to be a high correlation with pain and myofascial pain syndrome. this study will include an experimental (trigger point injection) and control (sham injection) group who are all undergoing a total knee arthroplasty. this is a pilot study that will include a maximum of 100 total patients (although it is planned for the study to be much smaller with a planned 10-15 patients per group). the procedure that will be completed is a trigger point injection with use of 1% lidocaine without epinephrine along the distal aspect of the vastus medialis and lateralis, proximal aspect of the medial and lateral gastrocnemius muscle bellies. the sham injection will be completed by pressing the needle against the skin without injecting any fluid. there will be a "blind" between the patient and the needle with both arms of the study. these patients will be followed up on pod1, and during weeks 2 and 6 follow-up where they will be given questionnaires to assess pain (visual analogue scale) and opioid use, and asked to bring their opioid medications to the clinic to assess the morphine milligrams equivalent (mme).


Eligibility criteria:
inclusion criteria: * aged 45 years or older * planned to undergo primary total knee arthroplasty * able to speak, read, and understand english * willing to complete a study questionnaires * willing to bring in their medications to be counted * dod beneficiaries * no allergy to lidocaine * not fearful of needles. exclusion criteria: * chronic opioid users (daily use of prescribed opioids for at least 90 days) * diagnosed with fibromyalgia * non-english speaking * unable to read english * unable to understand english * pregnant * allergy to lidocaine * not willing to complete study questionnaires * not willing to bring in their medications to be counted * not a dod beneficiary * fearful of needles
safety study of oral pirfenidone in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis

Conditions: Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Summary: to assess the safety of treatment with pirfenidone (up to 3600 mg/d) in patients with pulmonary fibrosis/idiopathic pulmonary fibrosis (pf/ipf).

this study has been designed as a rollover study to collectively include safety data from various previous studies. in addition, intermune has also initiated an early access program to make pirfenidone available to a limited number of patients with idiopathic pulmonary fibrosis in the united states. this program is also being conducted under this protocol. registration of patients with documented ipf has been closed as of october 2005.

Eligibility criteria:
general inclusion criteria: * able to understand and sign an informed consent form * understand the importance of adherence to study treatment and the study protocol, including concomitant medication restrictions, throughout the study period * patients must be willing to travel to an approved regional center for all study-related visits roll-over criteria: * entry into study through rollover has been completed criteria for early access program patients: * clinical symptoms consistent with ipf ≥3 months duration * age 40 - 85, inclusive * at the time of registration with national organization for rare disorders (nord), patients with ipf must have a percent predicted forced vital capacity (fvc) of ≥50%, and percent predicted carbon monoxide diffusing capacity (dlco) of ≥35% * at the time of enrollment in pipf-002, (screening/baseline visit) percent predicted fvc must be ≥45%, and percent predicted dlco must be ≥30% * high-resolution computed tomographic scan (hrct) showing definite ipf. for patients with surgical lung biopsy showing definite or probable usual interstitial pneumonia (uip), the hrct criterion of probable ipf is sufficient * for patients aged \<50 years: open or video-assisted thoracoscopic (vats) lung biopsy showing definite or probable uip. in addition, no features supporting an alternative diagnosis on transbronchial biopsy or bronchoalveolar lavage if performed * for patients aged ≥50 years: at least one of the following diagnostic findings as well as the absence of any features on specimens resulting from any of these procedures that support an alternative diagnosis: 1) open or vats lung biopsy showing definite or probable uip; 2) transbronchial biopsy showing no features to support an alternative diagnosis; 3) bronchoalveolar lavage (bal) showing no features to support an alternative diagnosis

Keywords: pulmonary fibrosis respiratory diseases
thoracoscopic sentinel lymph node biopsy in patients with stage i or stage ii breast cancer

Conditions: Breast Cancer

Summary: rationale: diagnostic procedures, such as thoracoscopic sentinel lymph node biopsy, may help find breast cancer that has spread to lymph nodes between the breasts. it may also help doctors plan the best treatment. purpose: this clinical trial is studying how well thoracoscopic sentinel lymph node biopsy finds sentinel lymph nodes that are located between the breasts in patients with stage i or stage ii breast cancer.

objectives: * determine the occurrence rate of internal mammary sentinel lymph nodes in patients with medially or centrally located stage i or ii breast cancer. * determine the safety, feasibility, and success rate of thorascopic internal mammary sentinel lymph node biopsy in these patients. * determine the rate of metastatic disease in internal mammary sentinel lymph nodes obtained thoracoscopically in these patients. outline: patients undergo standard axillary sentinel lymph node dissection during surgery (i.e., lumpectomy or mastectomy). patients receive a radioactive tracer (i.e., technetium tc 99m sulfur colloid) and isosulfan blue by peritumoral injection for identification of the axillary and internal mammary sentinel lymph nodes (imsln). identified axillary sentinel lymph nodes are dissected. identified imslns are removed through the lumpectomy/mastectomy incision, if accessible. if they are not accessible, patients undergo thorascopic imsln biopsy to remove the nodes. all removed sentinel lymph nodes (axillary or internal mammary) are examined for gross and microscopic carcinoma for future therapy planning. projected accrual: a total of 50 patients will be accrued for this study.

Eligibility criteria:
disease characteristics: * histologically confirmed breast cancer * stage i or ii disease (t1-t2, n0, m0/mx disease) * no chest wall invasion by tumor (t3 disease) * medially or centrally located lesion * no multicentric disease * multifocal disease allowed * no clinically positive axillary nodes * no enlarged internal mammary nodes by ct scan * hormone receptor status not specified patient characteristics: * male or female * menopausal status not specified * american society of anesthesiologists (asa) physical status classification 1-2 * not pregnant or nursing * negative pregnancy test * no other concurrent known, invasive malignancy * no known chronic pulmonary disease * no known allergy to methylene blue or isosulfan blue prior concurrent therapy: * no prior thoracic or cardiac surgery * no prior ipsilateral chest tube placement * contralateral chest tube placement allowed * no prior neoadjuvant chemotherapy * no prior radiotherapy to the mediastinum

Keywords: stage i breast cancer stage ii breast cancer male breast cancer
healing of burns and the effect of shockwave therapy on the recovery of skin grafts

Conditions: Burn Wound and Skin Graft Healing

Summary: the study is to review whether musculoskeletal shockwave therapy (eswt) can speed up the healing of second-degree burns as well as skin-graft donor sites. in both cases, the primary hypothesis is the shortened period leading up to the complete healing of the wound (reepithelization). the secondary hypothesis in the course of the study assesses: the rare manifestation of undesirable local events (e.g. reddening, swelling, hematoma).

eswt is administered as a one-off treatment on the wound surfaces within 24 hours of a 2nd degree burn trauma and immediately after an intraoperative skin graft excision procedure. a defocused sound head is orthogradely applied to the burn wound or the donor site. 100 impulses/cm² is administered at 20 seconds per cm². the defocused sound head is placed on the wound along with a sterile gel (lavaseptgel®, octenidingel®) and a sterile protection foil. the shockwaves deployed are not at an energy density that is painful. this single application of eswt is followed by routine dressing using mepitel® in combination with polyhexanid/octenidin®.

Eligibility criteria:
inclusion criteria: group a (n=50): consent-capable male and female patients between ≥18 and ≤80 years of age who have sustained a superficial 2nd degree burn on ≥1% and ≤30% of the surface of the body. group b (n=50): consent-capable male and female patients between ≥18 and ≤80 years of age who have sustained a deep 2nd degree burn on ≥1% and ≤30% of the surface of the body. group c (n=50): consent-capable male and female patients between ≥18 and ≤80 years of age who require a skin excision for the purpose of a skin graft. the minimal size of the skin-graft donor site must not be less than 1% of bbs. exclusion criteria: general exclusion criteria 1. pregnancy 2. below 18 or above 80 years of age 3. burns requiring artificial respiration, since consent for the study participation is unobtainable 4. extent of burns ≤1% to ≥30% of the body surface anamnestic exclusion criteria 1. diabetes mellitus requiring insulin 2. dialysis-dependent 3. ongoing chemotherapy treatment 4. drug abuse 5. systemic skin diseases 6. systemic and local cortisone therapy local exclusion criteria excluded from the study are those with burns in the regions: 1. head, face, neck 2. proximal ventral and dorsal thorax

Keywords: musculoskeletal shockwave therapy