cyrilzakka/clinical-trials huggingface dataset:
Chewing in Children With Repaired Esophageal Atresia-tracheoesophageal Fistula

The investigators aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the tolerated food texture of children.

The diet of children with normal feeding skills includes a combination of liquid, semisolid and/or solid foods. Chewing dysfunction (CD) in children may cause restrictions in solid food intake, thereby may result in insufficient food intake and delay in growth. It is aim to evaluate chewing function in children with repaired esophageal atresia-tracheoesophageal fistula (EA-TEF). Patients with repaired EA-TEF will be evaluated for age, sex, type of atresia. Each child will be required to bite and chew a standardized biscuit. Chewing function will be scored with the Karaduman Chewing Performance Scale (KCPS). The International Dysphagia Diet Standardisation Initiative (IDDSI) will be used to determine the tolerated food texture of children.

Eligibility Criteria:
Inclusion Criteria:

* Children with repaired esophageal atresia-tracheoesophageal fistula, without airway aspiration, intact airway closure

Exclusion Criteria:

* Children without repaired esophageal atresia-tracheoesophageal fistula, with airway aspiration, insufficient airway closure
Microbiological Study on Maxillary Complete Dentures of Two Different Materials

Cross over design the investigator divide participants to two groups group (A) will receive rapid heat cured denture base material and group (b) will receive the acrylic denture modified by titanium dioxide nanoparticles and after washout period alternatively group (a) will receive the acrylic denture modified by titanium dioxide nanoparticles AND group (b) will receive rapid heat cured denture base material the investigator will take swaps from dentures to count the anaerobic bacteria.

First the investigator will take primary impression, and pour it obtain primary cast, then will fabricate special tray an take secondary impression and obtain master cast after that duplication of master cast will be done the investigator will make cross over design.and divide participants to two groups group (A) will receive rapid heat cured denture base material and group (b) will receive the acrylic denture modified by titanium dioxide nanoparticle and after washout period alternatively group (a) will receive the acrylic denture modified by titanium dioxide nanoparticle AND group (b) will receive rapid heat cured denture base material the investigator will take swaps from the different dentures to count the anaerobic bacteria by (CFU).

Eligibility Criteria:
Inclusion Criteria:

1. Completely edentulous maxillary arch and partially dentate mandibular arch with adequate interarch space.
2. The edentulous ridges should be covered by firm healthy mucosa. 3-Angle class I maxillomandibular relation. 4-Healthy and cooperative patient

Exclusion Criteria:

1. Patients with bad habits as severe clenching or bruxism, drug or alcohol addiction, moderate or heavy smoking (greater than 10 cigarettes per day).
2. Previous history of radiotherapy or chemotherapy.
3. Any skeletal problem dictates surgical intervention
Study of Motexafin Gadolinium With Whole Brain Radiation Therapy Followed by Stereotactic Radiosurgery Boost in the Treatment of Patients With Brain Metastases

The primary purpose of the study is to evaluate if motexafin gadolinium with whole brain radiation therapy followed by a stereotactic radiosurgery boost is a safe and effective treatment.

Patients will receive three weeks of whole brain radiation therapy concurrent with daily motexafin gadolinium during weeks 2 and 3, followed by a stereotactic radiosurgery boost concurrent with motexafin gadolinium. Patients will be followed for radiologic response, neurologic progression, and neurocognitive progression.

Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years
* Karnofsky performance status (KPS) ≥ 70
* Histologically confirmed malignancy with the presence of one to four intraparenchymal brain metastases
* Each patient must sign a study-specific Informed Consent form

Exclusion Criteria:

* Previous cranial radiation
* Complete resection of all known brain metastases
* Known leptomeningeal metastases
* Known liver metastases
* Clinical or radiologic evidence of progression (other than study lesion\[s) within 1 month prior to enrollment
* Patients with metastases within 10 mm of the optic apparatus
* Patients with metastases in the brainstem, midbrain, pons, or medulla
* Planned chemotherapy during WBRT and/or SRS
* Uncontrolled hypertension
* Women who are pregnant or lactating

and Laboratory values as follows:

* LDH \> 1.3 x upper limit of normal (ULN)
* ANC \< 1500/mm3
* Platelets \< 50,000/mm3
* Creatinine \> 2.0 mg/dL
* AST or ALT \> 3 x ULN
* Total bilirubin \> 2 x ULN
Gentamicin Bladder Instillation in Individuals With Spinal Cord Injury Having Chronic Urinary Tract Infections

Participants will undergo daily gentamicin bladder instillations to determine if its use will reduce the rate of symptomatic urinary tract infections (UTIs) as well as the use of oral and intravenous antibiotics in adults with chronic spinal cord injury (SCI) who have recurrent UTIs. Participants are randomized into one of three groups: 1) Gentamicin and saline instillation 2) Saline only instillation 3) Standard of care, no instillation.

The purpose of this study is to determine if twice daily bladder flushing with an antibiotic solution will decrease the rate of UTIs and the use of oral medications used to treat UTIs. The occurrence of UTIs in the SCI population is high, with a rate of about 2.5 episodes per year. The inability to effectively empty the bladder increases the risk of UTIs, which are the most common medical complication after SCI. This study will help us understand the effectiveness of a local bladder therapy on preventing UTIs and improving bladder function in individuals with SCI.

Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age;
* Non-progressive spinal cord injury;
* Stable medical condition;
* Bladder dysfunction as a result of spinal cord injury
* History of recurrent UTIs (defined as 3 or more within the past year or 2 or more within the past 6 months).

Exclusion Criteria:

* Signs or symptoms of serious UTI that requires the use of systemic antibiotics;
* Use of any urine-acidifying agent, bladder irrigant, or systemic antibiotic within the previous 2 weeks;
* Participants colonized with gentamicin-resistant bacteria on baseline urine culture or a gentamicin allergy/sensitivity;
* Participants with known hearing loss and/or renal disease;
* Pregnant at the time of enrollment or planning to become pregnant during the time course of the study.
Gestational Diabetes Mellitus and Cardiovascular Disease: The Role of Vascular Dysfunction

The purpose of this research study is to look at whether there are differences in blood vessel function, risk for developing diabetes (high blood sugar), lipid (blood fat) levels, and levels of other blood markers between black women and white women who have or do not have gestational diabetes mellitus.


Eligibility Criteria:
Inclusion Criteria:

* Healthy women of self-identified African descent (black) and European (white) ancestry,
* 18-40 years of age,
* Body mass index \< 35 kg/m2
* History of regular menstrual cycles,
* Are currently pregnant and in third trimester of pregnancy (after 24 weeks gestational age)
* Have no pregnancy-associated complications to-date
* Are in good health free of hypertension, as well as thyroid, cardiac, or renal disease.

Exclusion Criteria:

* History of smoking
* Are taking potentially vasoactive medications
Overcoming Barriers in Vision Care Utilization of African Americans With Diabetes

The goal of this project is to implement a Collaborative Translational Research Center (TRC) Network Study which aims to assure optimal two-way communication between ophthalmologists and their patients' primary care physicians (PCP). The Collaborative TRC Network Study will have 2 objectives:

* To design and develop common research protocols to develop a 4-year retrospective database (2007-2010) that compiles electronic billing and medical chart information that can be used to study individual-level, clinical-level and system-level factors that impact access to and quality of vision care;
* To evaluate adherence to dilated fundus exams (DFEs) follow-up as the primary measureable quality indicator, and its relationship to the patients' demographics, ethnicity, socioeconomic status (SES), severity of diabetic retinopathy (DR), other ocular and medical co-morbidities, presence of HA1C, and primary care provider (PCP) communication.

By enhancing communication and strengthening the clinical information exchanged between PCPs and eye care professionals, this Collaborative TRC Network study will help to overcome barriers to obtaining ongoing DFEs and reduce disparities in vision care utilization.

Since its inception in October 2010 Collaborative Network Research Study at the Wills Eye Institute has aimed:

1. to establish a retrospective analysis of existing ophthalmic data sets to assess and evaluate system-level and individual-level factors that impact access to and quality of vision care in patients with diabetes;
2. to implement telephone-based and educational interventions to improve DFE follow-up adherence in African Americans with diabetes utilizing a prospective, cluster-based, randomized cohort design;
3. to determine the feasibility and effectiveness of using a non-invasive, non-mydriatic fundus camera (Nidek) in a community-based pharmacy setting to screen and detect diabetic retinopathy and other ocular diseases among individuals with diabetes.

Eligibility Criteria:
Inclusion Criteria for Aim 1:

1. Age ≥ 18 years
2. Type 2 diabetes mellitus
3. Had a dilated fundus exam (DFE) within the past four years (2007-2010).

Exclusion Criteria for Aim 1:

1) Pregnant women

Inclusion Criteria for Aim 2 and 3:

1. Age ≥ 18 years
2. Type 2 diabetes mellitus
3. Access to a telephone
Study of the Effects of Chinese Herbal Medicine on Chronic Urticaria

Urticaria is a common dermatology disease. Urticaria affects nearly 25% of the population at some time in their lives. Recurrent skin itch, insomnia, daily activities limitation greatly affect the quality of life. Some patient with chronic urticaria who had poor response to antihistamine may need second line medication. In United States, up to 54% chronic urticarial patient use oral corticosteroid to control. However, long-term use of oral steroids still needs to consider the impact of its side effects. Therefore, patients may seek for alternative medicine as an adjuvant therapy.

It is still lack large-scale clinical trials in Traditional Chinese Medicine research of chronic urticarial. The aim of this study is to conduct a double-blind, randomized clinical trial to analyze the effectiveness of Chinese medicine in chronic urticaria and its possible mechanisms.

Traditional Chinese medicine has been used widely in Taiwan for several diseases, such as allergic rhinitis, atopic dermatitis. For urticaria,certain antipruritic Chinese herbal medicine, such and Xiao-feng-san (XFS), Qing-shang-fang-fen-tang (QSFFT), have been commonly used in clinical practice, yet no clinical trials have been done to prove the effectiveness.

In this study, a double-blinded, randomized, placebo control trial is designed and total 100 chronic urticaria patients will be enrolled. All subjects will be divided into Chinese herbal medicine (CHM) and placebo control groups, in 1:1 allocation ratio. CHM group will receive capsule of mixture of XFS and QSFFT, 4gm four times a day, total 16 gm in a single day; while control group will receive placebo capsule with similar look, smell, and taste with same scheme. Total 1 month treatment course with 1 month follow-up study course will be done. Changes in symptom severity is the primary outcome, while improvement in sleep disturbance, and serologic marker evolution are the secondary outcome.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosed as idiopathic urticaria at least 6 weeks
* Ages from 18 to 75 years
* Symptom severity must be above 10 points (UAS7 scoring)
* Will to complete questionnaires and take medicine as schedule in this study
* Volunteer for study enrollment and sign inform consent

Exclusion Criteria:

* Other dermatological diseases related to skin pruritus, judged by clinician
* Systemic diseases, such as cancer, renal diseases, liver diseases, autoimmune diseases, and acute infectious diseases. Judged by clinician
* Using oral/injected steroid, leukotriene inhibitors, immuno-suppressant, or other Chinese herbal medicine during one month before enrollment
* Abnormal hemogram, liver or renal function tests in laboratory examination
* Women who are pregnant or are planned to conceive
Step and Walking Pattern From Cardiac Monitor Study

To understand the feasibility of characterizing walking patterns in heart failure subjects and subjects at risk for arrhythmias using an investigational wearable monitor called the SWAN study system.

This is a non-randomized, feasibility study that will enroll up to 60 participants diagnosed with Class II (30-35%) or III (30-35%) heart failure or are indicated for an insertable cardiac monitor with no history of heart failure (30-35%).

There will be one study visit per participant and a follow up phone call. The study visit includes device placement and data collection during rest and during a 6 minute hall walk. The device will then be removed.

Eligibility Criteria:
Inclusion Criteria:

* Subject is 18 years or older
* Willing and capable to provide written informed consent and agrees to participate in all protocol required activities
* Subjects must meet one of the following criteria:
* Documented New York Heart Association (NYHA) class II or III heart failure within the last 6 months

OR

* Subjects that have a known heart condition (non-heart failure) and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia such as dizziness, palpitations, syncope, chest pain and/or shortness of breath

Exclusion Criteria:

* Not able to walk continuously for a period of 6 minutes at the subjects baseline walking speed
* Prior hospitalization or surgery that affects the subjects baseline walking speed at time of enrollment
* Cardiovascular event such as unstable angina or myocardial infarction that affects the subjects baseline walking speed at time of enrollment
* Subject is currently enrolled in another clinical trial (excluding registries) that may interfere with the placement of the study system
* Known allergy to materials used in the study (adhesive tape, titanium, ECG electrodes)
* Subject is pregnant as indicated by subject report and/or medical record at the time of enrollment
* Subjects with rash or open wound on torso locations where investigational devices will be placed
* Have an active implantable device
* Any past or current medical event that could represent a risk for the subject to perform the study required activities in the opinion of the investigator
* Any medical signs or symptoms that in the opinion of the investigator could represent a risk for the subject (I.e. increased baseline blood pressure or heart rate).
Neuro-affective Response to Light in Depressed Adolescents and Young Adults

The goal of this neuroimaging pilot study is to understand developmental differences in the impact of therapeutic wavelength light (blue light) versus a non-therapeutic wavelength (red light) on emotional brain function in depression. The main questions this study aims to answer are:

* Does acute exposure to blue light (vs red light) stabilize emotional brain function in depressed individuals?
* Are stabilizing effects of blue light (vs red light) stronger for blue light in adolescents than young adults?

Participants will complete:

* A magnetic resonance imaging brain scan, in which we will examine the effect of blue versus red light on emotional brain function at rest and in response to rewards and losses.
* A pupillometry test of sensitivity to blue vs red light
* Clinical interviews and surveys
* Screening measures for drug and alcohol use, MRI safety, and current pregnancy \[if relevant\]
* Home sleep tracking with sleep diary and actigraphy for one week


Eligibility Criteria:
Inclusion Criteria:

* DSM-5 major depressive episode
* (If \<18yr) Parent or guardian can attend the baseline clinical interview

Exclusion Criteria:

* Unable to read and write in English
* Intellectual disability.
* Left or mixed handedness
* Use of psychotropic medication other than stable Selective Serotonin Reuptake Inhibitor (SSRI) medication (\> 2 months)
* Lifetime bipolar disorder or schizophrenia, or substance/alcohol disorder in the past 3 months.
* Factors influencing light and color sensitivity (i.e., color-blindness, serious ophthalmological conditions, photo-sensitizing medication).
* Factors influencing the ability to maintain a stable sleep schedule (i.e., shift work, severe sleep disorders, extremely late or early sleep schedule).
* Severe medical illness, neurological disorders, or history of head trauma.
* Current pregnancy or nursing
* MRI contraindication (e.g., metals in the body, recent tattoo, claustrophobia)
* Positive alcohol or substance use screen at MRI visit
Advance Care Planning Training for Nurses

The aims of this study are to examine the effectiveness of a multi-media experiential training programme in advance care planning (ACP) for nursing staff in acute care settings. The main questions it aims to answer are:

* can the programme enhance nurses' decision-support skills
* can the programme strengthen nurses' knowledge and confidence, and improve their attitude toward ACP?

Researchers will compare the participants in the intervention group (receive training programme) with those who are in the control group (receive no intervention) to evaluate the effectiveness of the programme.

The study adopts a cluster randomised controlled trial with 12 weeks (T2) and 24 weeks (T3) follow-ups. A total of 234 eligible nurses working in 26 acute care hospital wards will be randomised at ward level in a 1:1 ratio into either control or intervention arms. Guided by the Theory of Planned Behaviour, we will conduct path analysis to assess the role of nurses' knowledge, attitudes and confidence on the nurses' skill performance on decision support after the intervention.

Eligibility Criteria:
Inclusion Criteria:

* registered nurse with at least two years' clinical experience

Exclusion Criteria:

* had prior specialty training in Advance Care Planning communication.
PBMT Influence on Alveolar Socket Preservation

Goal of this study is to compare between the effect of two different low power lasers on extraction socket healing.

After molar tooth extraction, 6 Low power (PBMT) laser sessions.

Evaluation:

Visual Radiographic Histological

Eligibility Criteria:
Inclusion Criteria:

* Fit for implant rehabilitation.
* Acceptable oral hygiene.
* Willingness to attend 6 visits within 15 days of extraction.

Exclusion Criteria:

* Uncontrolled diabetes.
* Sub optimal oral hygiene.
* Heavy smoker.
Carotid Plaque-Burden Scale and Outcomes. A Real Life Study

Carotid ultrasonography has been proposed as a tool for prediction of future cardiovascular disease (CVD). Nevertheless, its role in clinical practice remains controversial.

Methods: The investigators analyse the incidence of CVD and mortality in a cohort of 1004 participants without preexisting CVD according to a simple plaque scale recorded in different segments of the carotid artery assess by ultrasound. A prognostic tool for CV events was development adding Carotid Plaque-Burden (CPB) scale to the Systematic COronary Risk Evaluation (SCORE2) table (CPB- SCORE2 scale).

Based in number of plaques and stenosis a simple plaque scale was recorded in different segments of carotid artery, involving a cohort of 1004 participants with vascular risk factors. Outcomes were recorded during 14 years. A prognostic tool for CV events was development adding simple Carotid Plaque-Burden (CPB) scale to the SCORE2 table (CPB- SCORE2 scale).

Eligibility Criteria:
Inclusion Criteria:

* Any of these vascular risk factors: Total cholesterol \>200 mg/dL, hypertension, or diabetes, or receiving medication for them
* No cardiovascular disease: coronary, cerebral o peripheral arterial disease.

Exclusion Criteria:

* Associated conditions: cancer, heart failure, chronic obstructive disease, renal insufficiency, neurodegenerative diseases, rheumatic diseases or chronic infections.
* Neck anatomical barriers to perform ultrasound.
* Enrolled in a clinical trial.
* Attend \<70% of regular appointments
Allogeneic Adipose Derived Stem Cells for Werdnig Hoffman Patients

Spinal Muscular Atrophy (SMA) is an autosomal recessive disease of motor neurons. In the early 1980s, Werdnig from Vienna University and Hoffman from Heidelberg University described this disorder. So SMA type 1 was named Werdnig- Hoffman disease. This is the first genetic disorder that cause death after cystic fibrosis in infants with the prevalence of 1 in 6000 birth. Mutation in the SMN1 gene (Survival Motor Neuron) is the reason for the disease that cause decrease in the SMN protein production. So the alpha motor neurons in the spinal cord ventricle horn will be destroyed and it cause progressive paralysis and defenite death.No specific therapy is yet available for the treatment of Werdnig-Hoffmann disease. Treatment is not disease-modifying and just is supportive. SMA type 1 is diagnosed within the early 6 month after birth and accompanied with breath disorders and definite death in 2 years. The affected infants have a weak muscle tone and they couldn't even hold their head up. Perhaps the only open way for these patients is the application of stem cells that could deliver trophic factor to the apoptotic cells. So this study focuses on the effectivness of cell therapy via adipose derived mesenchymal stem cells on the probable phenotypic changes in these patients.


Eligibility Criteria:
Inclusion Criteria:

Age under 12 month, Weak muscle tone, Weakness in mobility, Patients sitting without full conduction of nerve Existence of home senses, Normal Brain function

Exclusion Criteria:

Age beyound 12 month, Brain abnormality, Loss of sensory functions Malignancies
Awareness, Information, and Resources for Lung Cancer Screening Program for Community-Partnered Lung Cancer Screening

This trial investigates an educational program called Awareness, Information, and Resources for Lung Cancer Screening Program in improving knowledge about lung cancer screening in medically underserved communities. This program aims to educate and remove barriers to lung cancer screening among medically underserved community members who are eligible for lung cancer screening, and to improve access to evidence-based screening guidelines for early detection for lung cancer in the Western New York area.

PRIMARY OBJECTIVES:

I. Collaborate with community organizations and leaders to leverage community-based assets to disseminate education about lung cancer screening.

II. Reach medically underserved, high risk community members. III. Enhance lung cancer screening knowledge among medically underserved, high risk community members.

IV. Navigate screening-eligible community members to lung cancer screening.

OUTLINE:

Participants complete the Roswell Awareness, Information and Resources for Lung Cancer Screening (AIR) Program over 45 minutes and then receive the High-Risk Lung Cancer Tip Sheet.

Eligibility Criteria:
Inclusion Criteria:

* Members of all races and ethnic groups are eligible for this study

Exclusion Criteria:

* Adults unable to consent