cyrilzakka/clinical-trials huggingface dataset:
EMST and Swallowing in Long-Term Survivors of HNCA

This study is a randomized trial examining the impact of expiratory muscle strength training (EMST) on oral intake, swallowing function, and swallow-related quality of life in persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously.

Twenty (20) persons treated for cancer of the head and neck (HNCA) with radiation therapy or chemoradiotherapy (RT/CRT) at least 5 years previously will be randomized to an 8-week program of either EMST only and Standard Care only in order to examine the impact of EMST on swallowing function. The EMST program will consist of 5 sets of 5 breaths, 5 days per week for 8 weeks at 75% of maximum expiratory strength. Patients randomized to the EMST group will use the EMST150 (product name) expiratory muscle strength trainer according to package instructions. Standard Care will include swallowing exercises designed to strengthen muscles that contribute to pharyngeal phase motor events and increase structural range of motion. Subjects will be instructed to practice these exercises following a progressive protocol 5 days per week for 8 weeks.

All subjects will be evaluated at baseline and at the completion of their rehabilitation program. Assessment will include measurement of maximum expiratory pressure (MEP), a videofluoroscopic swallow study (VFSS) to objectively document swallow function, administration of swallow-related quality of life (QOL) questionnaires, and documentation of current diet using the International Dysphagia Diet Standardisation Initiative (IDDSI) Drink Levels and Food Levels.

Eligibility Criteria:
Inclusion Criteria:

1. Subject was treated for cancer in the oral cavity, oropharynx, hypopharynx, larynx, or for an unknown primary at least 5 years prior to enrollment. Subjects may have had surgery as long as a minimum dose of 50 Gy of radiation was part of the treatment;
2. Subject must have a current swallow complaint or impairment; these include but are not limited to reduced oral intake, perceived difficulty with bolus transport (e.g. feeling of food sticking in throat); aspiration on various bolus consistencies;
3. Ability to follow directions and engage in a program of rehabilitation

Exclusion Criteria:

1. the subject's swallowing problems are unrelated to treatment for HNCA (e.g. cognitive impairment, history of stroke);
2. the subject presents with contraindications for EMST as specified in the EMST150 package insert unless cleared for participation by the subject's physician. These conditions include untreated hypertension, untreated gastroesophageal reflux diseas, recent stroke, lung disease, and pregnancy.
Family Supports and Beliefs Survey

Participants will complete a survey (The Family Supports and Beliefs Survey), which will measure their existing beliefs about the role of societal resources in supporting families and young children. Participants will randomly see one of four fictional scenarios and then be asked questions related to that scenario as well as items related to stress and self-efficacy. We hypothesize that the type of scenario a participant is presented with before taking a survey may affect how they answer subsequent questions.

This survey is being administered as part of a broader project designed to test items that are being developed for a new measure, the Survey of Parent/Provider Expectations and Knowledge Computer Adaptive Test (SPEAK CAT).


Eligibility Criteria:
Inclusion Criteria:

* Must live in the United States

Exclusion Criteria:

* Individuals who cannot complete the survey in English
* Individuals under the age of 18
The Avelle® Negative Pressure Wound Therapy System on Chronic Wounds

This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers.

This study seeks to demonstrate the performance of Negative Pressure Wound Therapy on chronic wounds such as diabetic foot ulcers and venous leg ulcers. The primary objective of the study is to demonstrate the performance and safety of Avelle Negative Pressure Wound Therapy on wound and wound fluid management when used in accordance with the instructions for use.

Participation in the study is anticipated to be two weeks. The Avelle™ NPWT System will be used for two weeks and participants will be seen for study visits during this time. Study participants will need to visit the doctor's office up to five times and, at a minimum, will be required to see the health care provider three times, dependent on the condition of the wound. Each visit is anticipated to last for approximately 45 to 60 minutes.

Eligibility Criteria:
Inclusion Criteria:

* Venous insufficiency as defined by CEAP Classification of C6 or C6R or Diabetic foot ulcer
* Stalled wound/failed treatment in the opinion of the investigator. Defined as a wound that has not progressed by more than 30% in the previous 4 weeks
* 1 qualifying wound which is amenable to NPWT
* Reliable and available for follow-up
* Low to moderate exudate
* Able to tolerate negative pressure
* \>18 years old at the time of consent
* Able and willing to provide informed consent

Exclusion Criteria:

* Known sensitivities or allergies to components of the Avelle™ Negative Pressure Wound Therapy System
* Necrotic wounds or wounds with eschar present
* Wound is too small or too large based on wound dressing (\> 1cm2 and \< 100cm2)
* Wound depth \>2cm
* Use of DuoDERM® gel /petroleum gel/ creams/oil-based products
* Active treatment for cancer or completed within the last 3 months
* Severe malnutrition in the opinion of the investigator
* Visible bone/tendon or exposed articular capsule
* Exposed blood vessels
* Clotting disorder
* Malignant wounds
* Systemic infection
* Untreated osteomyelitis
* Patients with HbA1c greater than 9 on Day 0 (Test to be performed within last 3 months)
* Wounds greater than 12 months old
* Previous failed NPWT within last 6 weeks on the qualifying wound
* Active Pregnancy
* Chronic Kidney Disease score of 5
EMR Versus CSP in the Treatment of Sessile Serrated Lesions Less Than 10mm in Size

A prospective, single-center, open-label, randomized controlled study to compare the effectiveness and safety of endoscopic mucosal resection (EMR) and cold snare polypectomy (CSP) in treating colorectal sessile serrated lesions (SSLs) less than 10mm in size.

1. Patients are undergone screening, surveillance, or therapeutic colonoscopy at the Endoscopy department of Gastrointestinal endoscopy center of Huadong hospital affiliated to Fudan University.
2. Randomize patients with suspicious sessile serrated lesions (SSLs) less than 10mm in size into 2 interventional groups based on Random function of Statistical Package for the Social Sciences (SPSS) 20.0, including (1) Group 1: Endoscopic mucosal resection (EMR) and (2) Group 2: Cold snare polypectomy (CSP).
3. Collecting variables which consist of primary and secodary outcomes.

Eligibility Criteria:
Inclusion Criteria:

* Aged between 35 and 75 years
* Suspected sessile serrated lesions less than 10mm in size in screening, surveillance or therapeutic colonoscopy
* 0-Is or 0-IIa according to Paris classification
* Type 1 according to NICE and JNET classification
* Type II according to pit pattern
* Patients must sign an informed consent form prior to registration in study

Exclusion Criteria:

* Unsuitable for removal by EMR or CSP
* Suspected dysplasia or malignancy
* Recurrent sessile serrated lesions after endoscopic resection
* Familial adenomatous polyposis, Lynch syndrome or serrated polyposis syndrome
* History of inflammatory bowel disease
* Patients taking anticoagulant and antiplatelet agents before the examination
* Severe illness or other high-risk conditions that prevent the patient from cooperating with or tolerating endoscopic therapy
* Refusal to sign the informed consent form or any other factors that are not suitable for enrollment or affect the ability to participate in the study
The Effect of Bench-model Training in Cognitive Learning in the Operating Room

Based on the motor learning theories, it is hypothesized that bench-model training will allow junior residents to be more interactive than trainees lacking similar active hands-on training.


Eligibility Criteria:
Inclusion Criteria:

* Students enrolled in first or second year of their residency from a variety of division

Exclusion Criteria:

* Residents from higher year
Reliability of Fluorescent Camera in Diagnosis of Occlusal Carious Lesion

This study will be conducted to compare the diagnostic predictive values of a light induced fluorescence camera and Caries detection dye versus visual assessment method in identification of occlusal carious lesion.

A total of 43 volunteer patients will be assigned in this study. Each patient must have at least two occlusal carious lesions. Each lesion will be evaluated by three diagnostic methods (D), where D1 represents light induced fluorescence camera, D2 represents Caries detection dye. And D3 represents visual assessment method (ICDAS criteria)

Eligibility Criteria:
Inclusion Criteria:

* Patients should be over 18 Years old
* Patient should have good oral hygiene and general health
* patients With at least 2 non-cavitated first and/or second molar teeth in each quadrant of maxilla or mandible

Exclusion Criteria:

* Known allergy to any component of the dyes used.
* Patients having caries at proximal, buccal, lingual surface.
* Previously placed sealants or restorations.
* Bruxism or malocclusion
Process Evaluation of a Residence-Based SARS-CoV-2 Testing Participation Pilot

Mixed-methods process evaluation of a residence-based asymptomatic SARS-CoV-2 testing participation pilot

Regular testing for SARS Coronavirus 2 (SARS-CoV-2) is an important strategy for controlling virus outbreaks on university campuses during the COVID-19 pandemic but testing participation rates can be low. The Residence-Based Testing Participation Pilot (RB-TPP) was a novel intervention implemented at two student residences on a large university campus in the UK over four weeks. The aim of the pilot was to increase the frequency of asymptomatic SARS-CoV-2 saliva testing onsite. This process evaluation aimed to determine whether RB-TPP was implemented as planned and identify implementation barriers and facilitators. A mixed-methods process evaluation was conducted alongside the RB-TPP. Evaluation participants were students (who opted in, or out of the RB-TPP) and staff with a role in service provision or student support. Monitoring data were collected from the intervention delivery team and meeting records. Data were collected from students via an online survey (n=152) and seven focus groups (n=30), and from staff via individual interviews (n=13). Quantitative data were analysed descriptively and qualitative data thematically.

Eligibility Criteria:
Inclusion Criteria:

* Student is living in one of the two participating halls of residence.
* staff with operational or student support role.
* consents to participate.

Exclusion Criteria:

* Student is not living in the hall of residence at the start of the RB-TPP.
* does not consent to participate.
Efficacy and Safety of BF2.649 in Excessive Daytime Sleepiness (EDS) in Parkinson's Disease

To compare the efficacy of BF2.649 over placebo (12 week Double-Blind Phase) and assess the long term safety and the efficacy maintenance(9 months Open-Label Extension Phase) of BF2.649 in the improvement of excessive daytime sleepiness in patients diagnosed with Parkinson's Disease.

As measured by the change from baseline in the Epworth Scale Scores (ESS) at Week 12 and at Week 51, in patients diagnosed with EDS in Parkinson's Disease.

Eligibility Criteria:
Inclusion Criteria:

* Patients with a documented history of Parkinson's disease according to UPDRS,fluctuating and non-fluctuating patients, Hoehn and Yahr score \<5;
* stabilized on optimal antiparkinsonian treatments unmodified for 4 weeks prior to study entry;
* presenting an Excessive Daytime Sleepiness as indicated by an ESS\>or=12

Exclusion Criteria:

* Patients with a known diagnosis of other degenerative parkinsonian syndromes (e.g. Progressive supra-nuclear palsy, multisystemic atrophy, corticobasal degenerescence, diffuse Lewy's Body dementia)
* Patients who have shift work, chronic or occasional sleep deprivation, circadian rhythm disorders
* Patients with a severe depression indicated by (BDI\>= 16)or at suicidal risk (BDI item G\>0) or depression treated for less than 8 weeks
* Patients with a cognitive impairment
Non-invasive Evaluation Program for TIPS and Follow Up Network

Evaluation of non-invasive prognostic parameters in patients receiving transjugular intrahepatic portosystemic shunt (TIPS) for complications of portal hypertension. Patients are cared according to the local standardized follow up program. Clinical and laboratory data from standard patient care are evaluated for potential prognostic value.

NEPTUN consists of liver cirrhosis receiving transjugular intrahepatic portosystemic shunt (TIPS) at the Department of Internal Medicine I, University of Bonn, Germany and receiving a structured routine evaluation and follow up program. The diagnosis of cirrhosis was based on clinical, hemodynamic and biochemical parameters, and ultrasound and/or biopsy criteria.

Eligibility Criteria:
Inclusion Criteria:

* Insertion of TIPS according to guidelines

Exclusion Criteria:

* Contraindication for TIPS
Efficacy of Muscle Energy Technique Alone and in Combination With Interferential Therapy for the Treatment of Non-specific Low Back Pain.

Single blind randomized control trail in which two groups were formed. Group A was given Muscle energy technique and Group B was given muscle energy technique in combination with Interferential therapy.

After getting the REC approval from The Neurocounsel Clinics, study was initiated from 21 May, 2023 to 20 September 2023. Sample size was calculated by Epitool which came 30. Following participants were included a) both genders b) age 20-50 years and followings were excluded a) DM b) Parkinson disease c) disc disorder d) MSK disorder were excluded from this study. Simple random sampling technique was used to randomize participants into two equal groups. group A was given MET and group B was given MET plus IFT. 2 sessions/week for 4 \& half weeks. Evaluation was done at PNS \& EQ-5D-5L (QoL). Pre and post test analysis was done by use of SPSS version 21 and level of significance was kept p\<0.05.

Eligibility Criteria:
Inclusion Criteria:

* both genders
* age between 20-50 years old
* non specific type of back pain

Exclusion Criteria:

* Diabetes Mellitus
* Parkinson disease
* Any other Musculoskeletal disorder
Remote Microphone (RM) - A Comparative Study

The purpose of this investigation is to evaluate objective outcomes in pediatric bone conduction hearing device (often termed "BAHA") users with and without remote microphone (RM) technology. In this study, two remote microphone technologies will be evaluated to determine benefit in speech understanding in noise.


Eligibility Criteria:
Pediatric RM Technology Group:

Inclusion Criteria:

* English speaking pediatric conduction device users and their guardian/s will be included for study.
* We will include pediatric patients 5 years of age to 17 years of age who have a conductive or mixed unilateral or bilateral hearing loss with a minimum of a 30 decibels (dB) air-bone gap.

Exclusion Criteria:

- Participants who do not meet the described inclusion criteria.

Normal Hearing Controls:

Inclusion Criteria:

* Adults greater than18 years of age.
* Hearing thresholds \< 25 dB 500 - 4,000 Hz.

Exclusion Criteria:

- Non-English speakers.
The Impact of Chemotherapy on Memory Function and the Development of Traumatic Symptoms in Children With Cancer

Background: While treatment for pediatric cancer has improved significantly over the past 40 years, the neurotoxic side-effects of the chemotherapy agents themselves are now being recognized. Two drugs suspected of having acute impact on memory performance in children are methotrexate (MTX) and steroids (GCs). In addition, new evidence suggests that this neurotoxicity might actually protect these children from traumatization.

Working hypothesis and aims: This project aims to examine the acute impact of MTX and GC chemotherapy on memory performance in children and young adults with cancer, and the subsequent impact on the development of traumatic symptoms. We hypothesize that MTX and GCs will each produce acute declines in memory performance and that children with greater reductions in memory performance will have fewer traumatic symptoms.

Methods: The investigators will recruit 45 children being treated with MTX or GCs at Dana Children's Hospital. To determine acute impact on memory, a battery of memory tests will be administered before and after a cycle of MTX and before and after a cycle of GCs. In addition, traumatic symptoms will be assessed at each post-chemotherapy evaluation point Expected results: The investigators expect poorer memory performance after MTX and after GCs and that these performance declines will correlate with lower rates of traumatic symptoms.

Importance: The immediate impact of MTX and GCs on memory is not well known, especially in children. In addition, recent findings have led us to hypothesize that chemotherapy-induced deficits in memory function would paradoxically protect these patients from the traumatization often associated with cancer and its treatment. The proposed study will test this novel hypothesis for the first time.


Eligibility Criteria:
Inclusion Criteria:

* Histologically proven diagnosis of acute lymphoblastic leukemia, non-Hodgkin's lymphoma, or osteosarcoma
* treatment protocol that includes at least one cycle of methotrexate or exogenous glucocorticoid
* informed consent to participate in the study, according to institutional guidelines
* fluency in Hebrew, English, or Arabic
* age 6 to 25

Exclusion Criteria:

* Cranial irradiation within the past year
* serious concomitant systemic disorders (including active infections) that would compromise the safety of the patient or compromise the patient's ability to complete the study
* active meningitis or seizures occurring less than a month before study enrollment
Persistent Atrial Fibrillation Ablation Trial

Persistent atrial fibrillation (AF) is a common and distressing condition, that can cause significant symptoms. AF ablation is a recognised technique to treat persistent AF, but can be technically difficult. This study compares percutaneous ablation to thoracoscopic surgical AF ablation.


Eligibility Criteria:
Inclusion Criteria:

* Symptomatic persistent or long-standing AF suitable for AF ablation.
* Age over 18 years old.
* Informed consent to participate in this study.

Exclusion Criteria:

* Pre-existing ILRs or permanent pacemakers that do not allow for continuous monitoring for AF occurrence, or are not MRI-safe.
* Unable to undergo general anaesthesia for AF ablation.
* Previous cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
* Scheduled for elective cardiac surgery, such as coronary artery bypass grafting or valvular surgery.
* Previous thoracic surgery.
* Participation in a conflicting study.
* Potential participants who are mentally incapacitated and cannot consent or comply with follow-up
* Pregnancy
* Other cardiac rhythm disorders
Food Habit Programming: Influence of Genetics and Early Nutrition in a Population of Preterm Infants

Influence of neonatal nutrition and growth on psychomotor development of 2 years preterm infants.-Joint influence of environmental factor (early nutrition) and genetics factors on feeding behaviour setting- up in a particular population of infants of whom nutrition and life conditions during first weeks of life were purely controlled.


Eligibility Criteria:
Inclusion Criteria:

* Preterm infants \< 33 SA who stayed at least 2 weeks after birth in Nantes hospital, included in the " Grandir ensemble " network, 2 years old in 2008 and 2009
Chemoprevention Trial for Uremia-Associated Urothelial Carcinoma

Primary Objective: To study if lycopene can improve the biomarker status of urothelial cells in patients with uremia-associated urothelial carcinoma.

Secondary Objective: To evaluate the general safety and tolerability of oral lycopene 30 mg per day for 12 weeks in uremic patients.

This is a renal function-stratified phase II chemoprevention trial. After 8 weeks of a run-in and washout period, participants will take lycopene, 30 mg per day for 12 weeks. The expression of intermediate biomarkers will be determined upon study entry after 8 weeks of run-in/washout, and after 6 and 12 weeks of lycopene supplementation. It takes at least 20 weeks to complete the course.

Eligibility Criteria:
Inclusion Criteria:

* Patients have pathologically-proven urothelial carcinoma (UC) with a clinical stage \<= T3N0M0
* Patients have no visible or identifiable residual UC after treatment with a life expectancy of \> 6 months
* Patients have remaining urothelium at risk of recurrence (transplanted renal unit excluded)
* No other active malignancy. Patients who have other primary malignancies should be treated successfully prior to the study entry and should be in a cure or remission state for at least one year.
* Patients are able to take lycopene capsules orally.
* Patients who sign and give informed consents and are willing to conform to the scheduled sampling of the blood, urine and/or tissue

Exclusion Criteria:

* Patients who have clinical stage \> T3N0M0 or metastatic disease
* Positive urine cytology. Patients who have positive cytology should be subjected to a serial diagnostic workup which may include renal echo, cystoscopy and ureterorenoscopy, and image studies (intravenous urography, computed tomography, magnetic resonance urography, retrograde or antegrade pyelography). If no recurrent or residual tumors are found, patients are still eligible for the study.
* Patients who have ever received systemic chemotherapy within 12 months
* Patients who have gastrointestinal malabsorption regardless of the etiology
* Have known allergic reaction to tomato or lycopene
* Patients who are participating or will participate in other clinical trials
* Patients who have active urinary tract infection can not be accrued until infection is effectively controlled
* Patient's age is less than 18 years
Retrospective Analysis of Procedural Aspects of Transcatheter Aortic Valve Implantation (TAVI) on Peri-procedural Stroke

Retrospective analysis of all patients receiving TAVI in the United Kingdom (UK). Stroke rates following TAVI are roughly 3%. There are several device and procedure related characteristics which may increase the risk of stroke. We will examine if there is a signal in the UK registry. This will be important is TAVI is to be extended down to lower risk patient cohorts.

Retrospective analysis of all patients receiving TAVI in the UK. Stroke rates following TAVI are roughly 3%. There are several device and procedure related characteristics which may increase the risk of stroke. We will examine if there is a signal in the UK registry. This will be important is TAVI is to be extended down to lower risk patient cohorts.

Factors to be examined include (but not limited to):

need for Pre-procedure Balloon aortic Valvuloplasty (BAV) Need for two valves need for post-dilatation need for rapid ventricular burst pacing

Eligibility Criteria:
Inclusion Criteria:

* Had TAVI procedure in UK

Exclusion Criteria:

* Nil
A Clinical Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris

The purpose of this study is to assess the safety and effectiveness of IDP-107 in treating patients with acne vulgaris.


Eligibility Criteria:
Inclusion Criteria:

* Presence of inflammatory and non-inflammatory lesions

Exclusion Criteria:

* Dermatological conditions of the face that could interfere with clinical evaluations
* Female subjects who are pregnant, nursing, planning a pregnancy, or become pregnant during the study