cyrilzakka/clinical-trials huggingface dataset:
Evaluation of 19-gauge vs 21-gauge EBUS TBNA in Assessing Thoracic Lymphadenopathy

This study compares the yield of 19-gauge needles vs 21-gauge needles during EBUS TBNA procedures.

Endobronchial ultrasound-guided transbronchial needle aspirate (EBUS-TBNA) is a technique used to take samples of body tissue inside the chest without having to undergo an operation.

During this procedure, a special telescope (called a bronchoscope) is inserted through the mouth into the airways. Ultrasound technology allows the doctor to see the structures just outside the airway. By being able to see the structures outside the airway, the doctor is able to safely pass a fine needle through the airway to take samples of abnormal tissue.

EBUS-TBNA is used to take samples of tissue from the mediastinum. The mediastinum is the part of the chest between the lungs, and contains the heart, gullet, windpipe and lymph nodes. This area of the body is usually difficult to access without open surgery, hence the use of EBUS-TBNA. EBUS-TBNA may be used to investigate enlarged lymph nodes. This may be due to tuberculosis, sarcoidosis or cancer.

Currently, smaller 21-gauge and larger 19-gauge needles are used during the EBUS-TBNA procedure at Regions Hospital. The purpose of this study is to find out which needle is better in finding the explanation for the enlarged lymph nodes, and any follow up procedures that may be necessary if the investigators are unable to get enough tissue during the EBUS-TBNA procedure (surgical sampling, radiological sampling, and/or follow-up imaging).

Eligibility Criteria:
Inclusion Criteria:

* Age 18 years or older
* Able to provide informed consent
* Referred for EBUS TBNA sampling at Regions Hospital

Exclusion Criteria:

* On therapeutic warfarin, Plavix, or ticagrelor in the past 5 days
* INR\>1.8 or platelets \<50K
A Pilot Study of FMT on CD Patients With AIEC

The goal of this pilot study is to test whether Fecal Microbiota Transplant (FMT) would be an effective antibacterial treatment for managing Adherent-invasive Escherichia coli (AIEC) colonization in Crohn's disease (CD) patients.

It aims to assess the safety of FMT in patients with clinically inactive or mild to moderate CD and to determine the presence of AIEC before and after FMT.

Participants will receive FMT via colonoscopy and have a follow-up colonoscopy at the end of the study.

Experimental and observational data suggest that intestinal inflammation in Crohn's Disease (CD) arises from abnormal immune response to intestinal microbiota in genetically susceptible individuals. Genes that regulate innate immune response, intestinal barrier function and bacteria killing of intracellular pathogens have been associated with an increased risk for developing CD in Caucasian populations. The search for specific pathogens in CD has identified in the intestinal mucosa of patients several candidates. One with much supporting evidence is the adherent invasive Escherichia coli (AIEC). Since its discovery in 1998, several groups have reported a higher prevalence of AIEC in CD patients compared to healthy subjects and confirmed their pro-inflammatory potential. A growing body of work indicates that different host environments can select such AIEC pathobiont. AIEC colonization in mice leads to strong inflammatory responses in the gut suggesting that AIEC could play a role in CD immunopathogenesis.

Faecal microbiota transplantation (FMT) represents a clinically feasible way to restore the gut microbial ecology and has proven to be a breakthrough for the treatment of recurrent Clostridium difficile infection. Clinical trials are being conducted to evaluate its use for other conditions including inflammatory bowel disease, irritable bowel syndrome, diabetes mellitus, non-alcoholic steatohepatitis and hepatic encephalopathy. Efficacy of FMT on CD endoscopic lesions and AIEC colonization remains to be demonstrated.

Eligibility Criteria:
Inclusion Criteria:

* \>18 years of age;
* Patients with CD history ≥ 3-month duration;
* Patients with no or mild-to-moderate symptoms defined as Harvey Bradshaw Index (HBI) \< 16 ;
* Patients with positive total E.coli antibodies (AEcAb)

Exclusion Criteria:

* Pregnancy;
* New biological treatment or steroids use within 4 weeks;
* Current Colorectal tumor;
* Active gastrointestinal bleeding;
* Having ulcerative colitis;
* Having colectomy or partial colectomy (less than ileo-transverse colonic anastomosis);
* Having colonic or small bowel stoma;
* Active perianal lesions;
* Receiving antibiotics within 4 weeks;
* Presenting psychological or linguistic incapability to sign the informed consent
Ultrasound - MRI Fusion Guided Injections in Muscles

This study is using a new technology of combining MRI and ultrasound images to help guide the injection into the correct muscles.

Combining MRI images with real-time ultrasound images is a new technology which has recently become available. Sometimes ultrasound images can be difficult to interpret, especially when there are problems with stiffness in the muscles. The MRI images create a "road-map" to help understand the ultrasound images at the time of the injection. This may help guide the injection, compared with using ultrasound alone. This technique has not currently been used in muscle injections, therefore we would like to use it as part of a research study.

This study is comparing current standard practice of using ultrasound guidance alone versus ultrasound guidance with an MRI road-map to direct muscle Botox injections.

Potential participants will be identified by referrals for Botox injections within the Radiology. They will be sent a copy of the Information leaflet. A week before the potential participant is due in Radiology, they will be telephoned by a member of the team, to see if they are interested in taking part in the study. Patients will be sequentially allocated to either the study group or the control group.

Consent will be sought when the patient attends for their ultrasound guided Botox injection. A visual analogue spasticity score will be taken. An initial MRI scan will be obtained of the musculature of the anatomical area. The MRI DICOM data will be uploaded to the ultrasound scanner and anatomical landmarks will be used for fusion, in the MRI fusion patient group. The MRI will then be used as a roadmap to guide the needle for injection into the appropriate muscle. In the control group, the MRI data will not be assessed - the patient will proceed with their injection with ultrasound guidance alone, as per current clinical best practice.

The Botox will be injected into the target musculature, in both the control and MRI fusion groups.

Immediately following on from the ultrasound guided injection and 20-minute recovery period, a subsequent MRI will be performed to confirm that the injectate was within the target muscle. The anatomical coverage and sequences used will be same as the pre-injection MRI.

Approximately 4 weeks post-procedure, a follow up phone call and a repeat spasticity visual analogue score questionnaire will be repeated over the phone. After which, the participant will have ended their time within the study.

Eligibility Criteria:
Inclusion Criteria:

* All adult patients with capacity and requiring an ultrasound guided Botox injection in the Radiology Department will be invited to take part in the study.

Exclusion Criteria:

* Children. People who cannot consent. Patients with contra-indications to MRI scanning
Role of Wireless Monitoring in Internal Medicine Unit for Ongoing Assessment of Acute Instable Patients

The present study was planned to provide clinical data on the impact of acute and critically ill patients in Internal Medicine Unit activity and economic data enabling to quantify the relative cost of acute patients management during ordinary hospitalization. In these critically ill complex patients the vital parameters continuous monitoring could help in improving the quality of care. Therefore, the study will check how the wireless continuous monitoring in acute selected patients is able to reduce major complications improving the patient's outcome and the quality of care and reducing costs compared to traditional monitoring performed at regular intervals by the nursing staff.

In recent years, Internal Medicine Ward, due to epidemiological transition, takes in charge more and more an heterogeneous group of patients with serious diseases both acute and chronic and elderly, frail, poly-pathological patients, requiring intensive care. Hospitalization of medical patients in large wards without prior stratification of severity, complexity, level of dependence, comorbidities and without a proper assessment of the risk of rapid clinical deterioration, can lead to suboptimal treatment, resulting in prolonged hospital stay and increased care costs. Continuous monitoring of vital parameters may allow early detection of deterioration in acute patients not admitted in intensive care such as those hospitalized in Internal Medicine Unit, allowing the staff to immediately address the patient's needs achieving promptly the most appropriate care. As there are no studies comparing the use of wireless monitoring systems and traditional vital signs monitoring in critical acute patients, the study was designed to highlight the benefits of continuous monitoring of vital signs in the first 72 hours hospitalization to reduce the major complications and improving outcome. The study also aims to assess the reduction in hospitalization costs using as proxy the decrease in average length of stay.

Eligibility Criteria:
Inclusion Criteria:

* all critical patients (with need for continuous monitoring and high technology) with MEWS ≥3 and / or NEWS≥5 at admission
* all patients with glycemic decompensation regardless of MEWS and NEWS.
* all critical patients severe fluid and electrolyte imbalance, regardless of MEWS and NEWS.

Exclusion Criteria:

* MEWS \<3 and or NEWS \<5
* Lack of informed consent
* Inability to understand and want
Self-Gated Breath-Hold Technique for Helical Tomotherapy in Patients With Non-Small Cell Lung Cancer

Non-small cell lung cancer (NSCLC) is a disease that often cannot be surgically operated on. As a result, treating the tumor with radiation has become the main standard of treatment. Radiation therapy though, is limited by various factors, including the difficulty in properly imaging the lung tumor since the lung can move up to 4 cm between breathing in and out. Consequently, a radiation oncologist must consider a larger area of the lung to treat with radiation - increasing the amount of normal tissue exposed to harmful rays and therefore leading to increased side-effects. Two techniques being explored into improving tumor management while minimizing the side effects in NSCLC are breath-held gating and tomotherapy. Breath-held gating is a technique for consistently imaging the tumor at the right moment in a patient's breathing cycle - decreasing the normal tissue exposed to harmful radiation. Tomotherapy, a new technique in delivering radiation, will further allow the investigators to focus treatment on the tumor and exclude more normal tissues. Therefore, they hope that these methods will prove to be a better way in treating people with NSCLC.

Non-small cell lung cancer (NSCLC) is a disease that often presents as an unresectable tumor. As a result, radiotherapy is the main standard of treatment. Unfortunately, radiotherapy is limited by several factors, including that the lung can move up to 4 cm between inspiration and expiration. As a result, a radiation oncologist often has to widen his treatment field to include for this motion. This leads to greater side effects for the patient. Two techniques that are being explored to improve the tumor control of radiotherapy and to minimize side effects to normal tissues in NSCLC treatment include breath-held gating and tomotherapy. Breath-held gating will allow the investigators to treat patients at the right moment in their breathing cycle consistently - minimizing the normal tissue exposed to radiation. In addition, both gated breathing and tomotherapy will allow the investigators to create a more refined tumor volume treated and exclude more of the normal tissues. Consequently, they hope these methods will prove to be a better way to treat patients with non-resectable NSCLC.

Eligibility Criteria:
Inclusion Criteria:

* Stage I-III NSCLC
* Karnofsky Performance Status (KPS) equal to or greater than 70
* Forced expiratory volume in 1 second (FEV1) equal to or greater than 1.0L

Exclusion Criteria:

* Myocardial infarction (MI) disease
* Recurrent disease
* Complete tumour resection
Acupuncture or Self-Acupuncture in Managing Cancer-Related Fatigue in Women Who Have Received Chemotherapy for Stage I, Stage II, or Stage IIIA Breast Cancer

RATIONALE: Acupuncture may help relieve fatigue caused by breast cancer. It is not yet known whether acupuncture is more effective than self-acupuncture in managing fatigue in women with breast cancer.

PURPOSE: This randomized phase III trial is studying acupuncture to see how well it works compared with self-acupuncture in managing cancer-related fatigue in women who have received chemotherapy for stage I, stage II, or stage IIIA breast cancer.

OBJECTIVES:

* Assess the efficacy of a course of acupuncture in the management of cancer-related fatigue in a homogeneous sample of women with stage I, II, or IIIA breast cancer who have completed adjuvant chemotherapy.
* Assess the efficacy of self-acupuncture in comparison to therapist-administered acupuncture in sustaining, in the longer term, any effects observed with a 6-week course of acupuncture in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to study center and fatigue score (low vs moderate vs severe). Patients are randomized at 3:1 ratio (arm I: arm II) to 1 of 2 treatment arms.

* Arm I (experimental): Patients undergo a 20-minute acupuncture session once a week for 6 weeks. Patients also receive written information about fatigue and its possible management.
* Arm II (control): Patients undergo standard care. They also receive written information about fatigue as in arm I.

After 6 weeks, patients in arm I are again randomized to 1 of 3 arms.

* Arm A: Patients receive treatment as in arm I for 4 more weeks.
* Arm B: Patients receive treatment as in arm II for 4 more weeks.
* Arm C: Patients learn to self-acupuncture and do so weekly for 4 more weeks. All patients complete questionnaires on fatigue, hospital anxiety and depression, quality of life, and use of complementary therapies at baseline and periodically during study. Patient's sociodemographic and treatment characteristic records are also reviewed.

After completion of study therapy, patients are followed up periodically for 18 weeks.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of breast cancer

  * Stage I, II, or IIIA disease
* Completed prior chemotherapy for ≥ 1 month and up to 5 years

  * No needling on the ipsilateral arm of patients who have undergone axillary dissection
  * No needling on the lymphedematous limbs
* Score of ≥ 5 on a 0-10 single-item screening fatigue scale, where 0 is no fatigue at all and 10 is extremely fatigued
* Hormone receptor status not specified

PATIENT CHARACTERISTICS:

* Life expectancy ≥ 6 months
* Menopausal status not specified
* Platelet count ≥ 50,000/mm\^3
* Hemoglobin ≥ 10 g/dL
* Hematocrit ≥ 30%
* Not pregnant
* No needle phobia
* No co-morbidity with any of the following:

  * Bleeding disorder
  * Thyroid dysfunction

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
* No planned concurrent chemoradiotherapy
* No concurrent steroids
* No concurrent epoetin alfa or transfusion for anemia
* No other concurrent complementary therapies
Single-use Cystoscope System for Direct Visualization of the Urethra and Bladder

In this study, the new aScope 4 Cysto is used to see how well it visualizes the lower urinary tract, and if this new flexible cystoscope performs as well as other routinely used cystoscopes. This study will be done in patients who have been diagnosed with bladder lesions and who will undergo surgery via the urethra to remove these lesions. The surgery is done under general anesthesia. After being brought under anesthesia and before removal of the lesion(s), the new flexible cystoscope is tested. The cystoscope will be used to visualize the urethra and bladder. Data will be collected on the number of the lesions that can be seen using the new cystoscope. During the planned surgery a resectoscope or rigid cystoscope will be used to confirm the number of lesions. The data will be used to show how well the cystoscope visualizes the lesions in comparison with routinely used cystoscopes. It will give information on how well the structures of the urinary tract and bladder can be viewed including any abnormalities that are present.Data will also be collected on the handling of the cystoscope: how well the cystoscope moves into the lower urinary tract, and how well it can be navigated through the lower urinary tract.

Clinical Phase: pre-CE study

Design: A non-randomized confirmatory study on the visualization performance of the Ambu® aScope™ 4 Cysto and aView™ Urologia in 42 fully evaluable, adults subjects aimed at identification of known pathological findings (papillary bladder or small resectable lesion) detected with Ambu® aScope™ 4 Cysto and aView™ Urologia and subsequently during a repeat procedure using a reusable rigid scope or resectoscope at the time of planned transurethral resection of bladder tumours (TURBT).

Population: Adult subjects (≥ 18 years) in the OR undergoing planned transurethral resection of bladder tumors TURBT

Planned sample size: A total of 42 patients will result in a maximum (if the true proportion is 50 %) width of the two-sided 95 % confidence interval for the binary variable "Confirmed" to be 15%. This width is considered to be useful in the interpretations of the results from this investigation.

Study duration: Screening, procedure and follow-up will take 15 days maximum

Follow-up duration: Follow-up immediately after procedure

Investigational Device: Ambu® aScope™ 4 Cysto and aView™ Urologia Pre-CE, single use cystoscope.

Eligibility Criteria:
Inclusion Criteria:

* Willing to sign the informed consent
* Adults (males and females), ≥18 years of age or older
* Able to undergo routine cystoscopy
* Patients diagnosed with papillary bladder or small resectable lesion where transurethral resection of the tumour/lesion is planned

Exclusion Criteria:

* History of prior bladder/urethral reconstructive surgery
* Presence of symptomatic urinary tract infection (UTI)
* Known unpassable urethral stricture
* Unable to read and/or understand the study requirements
* Pregnant or lactating women
The Long-term Prognosis of Moderate to Severe Bronchial Hyperresponsiveness (BHR) in Asthmatic Preschool Children

The aim of investigator´s clinical trial is to investigate 52 patients aged three to five years with viral-induced asthma and 52 patients aged three to five years with allergic asthma. Over a time-span of 5 years the investigators will explore lung function and bronchial responsiveness. The investigators plan to evaluate long-term clinical history of moderate to severe bronchial hyperresponsiveness in preschool children with asthma. Therefore factors like atopy in children, parental atopy and bronchial hyperresponsiveness will be explored.

A positive family history with prevalence of atopy, eczema, wheezing are well-known factors predicting asthma. Caudri et al. found more important predictors like perinatal transmission, parental use of inhalative medications and wheezing/dyspnea out of viral infections(5). Measurement of BHR in children was in most studies a second outcome parameter.

Four visits will be performed, baseline and after 1, 3, and 5 years. At visit 1 the investigators will characterize all patients by a ISAAC survey. At each visit in children a methacholine challenge, a skin Prick test, eNO, RAST and total IgE will be performed. At visit 3 and 4 sputum will be induced. In parents only at the first visit a methacholine challenge will be performed. A genetic identification of ADAM33 gene from EDTA blood shall be provided. ADAMs are multidomain proteins with a metalloprotease domain, associated with airway remodelling. Visits should be kept in a time interval without asthma therapy and respiratory infection.

To examine the feasibility of methacholine challenges in preschool children data measured in 2006 will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* informed consent
* age 3 to 6 years
* diagnosis asthma
* pulmonary function: FEV1 (% pred.)≥ 70%
* ability to carry out 2 reproducible flow volume loops
* moderate to severe BHR (PD20 FEV1 ≤ 0,3 mg methacholine)
* more than 4 weeks interval since last infection
* 8 hours washout period of Short Acting Beta Agonist
* 1 week washout period of Ipratropium Bromide
* 1 week washout period of Long Acting Beta Agonist
* 4 weeks washout period of Systemic Corticosteroids
* 4 weeks washout period of Leukotriene Antagonists

Exclusion Criteria:

* Age \< 3 and \> 6 Years
* Pulmonary function test: FEV1 (% pred.) \< 70%
* Others chronic diseases or infections (e.g., HIV, tuberculosis, malignancy)
* Incapability to perform spirometry
* Current participation in another clinical trial
Combined Pulsed Dye Laser and Topical Ranibizumab for Treatment of Port Wine Stain Birthmarks

The purpose of this study is to improve port wine stain therapeutic outcome in response to laser therapy. The researcher want to determine whether the combined use of pulsed dye laser therapy and topical ranibizumab will improve port wine stain therapeutic outcome.

Combined use of pulsed dye laser to induce port wine stain blood vessel injury, and ranibizumab to prevent port wine stain blood vessel angiogenesis and recanalization after laser therapy, will improve port wine stain lesion blanching.

After pulsed dye laser treatment of the entire port wine stain, topical ranibizumab will be applied to two of the test sites for two weeks following pulsed dye laser therapy. The degree of port wine stain blanching which will be quantified objectively using visible reflectance spectroscopy measurements. port wine stain test site blanching responses following the combined use of pulsed dye laser and topical ranibizumab will be compared with pulsed dye laser only and with the baseline controls.

Eligibility Criteria:
Inclusion Criteria:

* Port Wine Stain suitable for comparison testing
* Age \> 18 years of age

Exclusion Criteria:

* History of photodermatoses or skin cancer
* use of known photosensitizing drugs
* use of immunosuppressive drugs or systemic steroids
* Pregnancy