cyrilzakka/clinical-trials huggingface dataset:
Review of Post-Study Clinical Endoscopy Reports in Follow Up to MAY2016-07-01

This study reviews post study clinical endoscopy reports in follow up to patients who participated in MAY2016-07-01 with weekly erlotinib for familial adenomatous polyposis. Reviewing follow up medical records may help researchers examine the extent of rapid progression of familiar adenomatous polyposis disease burden after discontinuation of weekly erlotinib.

PRIMARY OBJECTIVE:

I. To review clinical endoscopy reports, pathology reports, and other medical records related to standard-of-care endoscopic evaluations for all participants in the parent study, MAY2016-07-01, to determine the extent of reports of rapid progression of recurrent polyps after completion intervention and follow up under the parent protocol.

OUTLINE:

Patients who participated in MAY2016-07-01 undergo review of medical records.

Eligibility Criteria:
Inclusion Criteria:

* MAY2016-07-01 study participants for whom medical records are available and accessible

Exclusion Criteria:

* MAY2016-07-01 study participants who have opted out of medical records reviews or for whom consent for medical record review cannot be confirmed/documented
Viral Dynamics of Omicron in Children

SARS-CoV-2 transmission is dependent on multiple factors, which may be related to either host-virus interaction or the environment. While there have been several studies evaluation viral dynamics and transmission risk in adults, there is limited pediatric data available. The objective of this study is to characterize the period of communicability for children less than 19 years of age with SARS-CoV-2 infection with the Omicron variant.

The goal of our study is to assess the viral dynamics of SARS-CoV-2 infection in children \< 19 years with acute infection to inform public health practice.

Specific Aims:

1. Describe the kinetics of SARS-CoV-2 viral load in children with acute SARS-CoV-2 infection
2. Assess the impact of various host factors on viral dynamics, including age (\<1 year, 1-4 years, 5-11 years, 12-18 years), symptoms, clinical severity (hospitalization vs. outpatient), comorbidities (immunocompromised vs. not immunocompromised), vaccination (none, 1 dose, 2 doses)
3. Estimate the time point at which children are less likely to be infectious
4. Assess the sensitivity of self-collected rapid antigen testing (RAT) in children, compared to PCR (e.g. assess RAT test performance in children)

Eligibility Criteria:
To be included in the study, the participant must be:

1. Less than 19 years of age
2. Have a positive molecular or rapid antigen test in the previous 48 hours
3. If symptomatic, onset of any COVID-19 symptom within last 72 hours.
4. If asymptomatic, evidence to support acute infection (e.g. negative PCR in the last 5 days, known household exposure where index case is clear)
5. Able to collect daily samples
FOOD PRESCRIPTION APP

This study will develop and test and app that will create meal plans to improve diet quality and support weight loss. This app will allow participants to customize their meal plans and substitute recipes for nutritionally equivalent options that they find more appealing, thus potentially increasing adherence.

We are specifically planning app to create meal plans that are affordable, meet the recommended dietary allowances (RDAs) and adhere to sustainability guidelines to reduce the food-related carbon footprint. The app will enable participants to customize their weekly meal plans. We hypothesize that having the ability to customize the weekly menus through a FoodRx app will improve outcomes, as the lack of customization appeared to be a barrier for some families to improve their diet quality and achieve weight loss goals. (eg, some families did not like tofu or oatmeal, and would have preferred a substitute). We will be able to test the impact of the Food Rx app by comparing participants who use it to our control group that does not currently have access to the standard menus/grocery delivery or FoodRx app.

Eligibility Criteria:
Inclusion Criteria:

Already enrolled in FoodRx study \>18 years BMI\>27 and wants to lose weight -

Exclusion Criteria:

Not enrolled in Food Rx

-
The Efficacy of Topical Vaginal Oxytocin Gel in Postmenopausal Women With Vulvovaginal Atrophy

A Phase three randomized, double-blinded, study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM.

A Phase three randomized, double-blinded, placebo- controlled study to asses the efficacy and safety of oxytocin gel in postmenopausal women with vaginal atrophy due to Genitourinary Syndrome of Menopause GSM. This study shall include 242 subjects. After screening , subject who meet eligibility criterial will be randomized in a 1:1 ratio to receive wither study intervention or placebo to be applied once daily for sixty days and followed up extra fifteen days. objectives is to evaluate the efficacy and effectiveness of topical oxytocin gel compared with placebo in improving postmenopausal vaginal atrophy symptoms in women with GSM , also assessing the safety and tolerability of topical oxytocin gel.

Eligibility Criteria:
Inclusion Criteria:

1. Postmenopausal, sexually active female subject of age 47 - 65 years, at the time of randomization, willing to provide an informed consent.
2. Physical Assessment showing vaginal atrophy (according to the following criteria: pale, smooth, or shiny vaginal epithelium, friable, epithelium showing no rugae, loss of elasticity or turgor of the skin, dryness of labia, fusion of labia minora, vulvar lesions, or erythema.) 3. Patients with at least one present symptom (ex. vaginal dryness, itching, burning, dysuria, and/or dyspareunia) and able to identify one symptom as the most bothersome symptom, with at least moderate severity.

4. Vaginal smear cytology at screening showing ≤ 5% superficial cells 5. Vaginal pH \> 5.0 at screening 6. A level of estradiol ≤ 30 pg/mL and a level of Follicle Stimulating Hormone (FSH) \> 40 milli International Units (mIU)/ml at screening 7. Be willing to abstain from sexual activity and the use of vaginal douching within 24 hours prior to vaginal pH measurements at screening and the study follow-up visits

Exclusion Criteria:

1. Previous treatment with other local non-hormonal moisturizers/hormonal products within 1 month or use of lubricants within 1 week prior to inclusion.
2. Women taking systemic hormone replacement or pills within the last 6 months.
3. Current or history of endometrial hyperplasia or uterine/endometrial, breast, or ovarian cancer, or undiagnosed vaginal bleeding
4. Any untreated urogenital infection within 14 days prior to randomization.
5. Ongoing treatment with systemic medications for other non-related health conditions which might impact the study results and have the potential to bring about change in the vaginal environment e.g. glucocorticosteroids, antibiotics, etc.
6. Critically ill patients.
7. Patients with severe renal impairment (GFR \< 30 ml/min/1.73 m2 as measured by the Cockcroft-Gault formula).
8. Patients with known severe hepatic impairment (Child-Pugh C; 10 - 15 points), biliary cirrhosis, or cholestasis.
9. Patients with known or suspected allergy or any contraindications to oxytocin.
Comparison Between Lathe Cut Versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity

"Comparison between Lathe Cut versus Cast Molding Soft Contact Lens Technique on Ocular Surface Integrity" investigates the impact of two different manufacturing methods on the health and integrity of the ocular surface.

The study aims to determine which technique, lathe cutting or cast molding, produces soft contact lenses that are more biocompatible and less likely to cause adverse effects on the eye. The findings from our research could have significant implications for contact lens wearers and manufacturers, guiding the production of lenses that promote better ocular health and enhance wearer comfort. Ultimately, this research contributes valuable knowledge to optometry and ocular surface disease management.

Eligibility Criteria:
Inclusion Criteria:

* Patients who have never used contact lenses
* Age of participants would be 15 to 35 years
* Patients free of any ocular pathology

Exclusion Criteria:

* Patients having astigmatism of more than 0.75DC
* Subjects with a previous history of ocular surgery, eye pathology, or systemic disease.
* Patients with abysmal compliance.
Asthma Control in Elderly Patients With Montelukast

To compare the efficacy of combination therapy of montelukast plus low dose inhaled budesonide and single therapy of medium dose inhaled budesonide on asthma control such as inflammatory markers and clinical indicators and to compare treatment response according to leukotriene related genotypes in elderly patients with asthma


Eligibility Criteria:
Inclusion Criteria:

* Patients aged 60 - 75 years
* Patients diagnosed with asthma (NIH, 2007) over six months ago
* Patients maintaining monotherapy of low dose inhaled budesonide (pulmicort 400µg/day or ciclesonide 160 µg/day or fluticasone 250 µg/day) or combination of low dose inhaled budesonide and LABA (Seretide® 250 µg/day or Symbicort® 320 µg/day ) for over a month before the participation in this trial
* Patients not reaching 'well controlled asthma status' with four-week monotherapy of low dose inhaled budesonide (Pulmicort 400 µg/day)
* Patients who sufficiently listen to the purpose and content of this trial and the properties of investigational products and voluntarily agree with the participation to sign a written consent approved by IRB of Ajou University Medical Center before the participation in this trial

Exclusion Criteria:

* Patients who show a symptom of an acute disease within 28 days before the beginning of this trial (administration of trial medication)
* Volunteers who are found to be unsuitable through screening tests
* Patients with history of hypersensitivity to montelukast or budesonide
* Patients participating in other clinical trial within three months before the beginning of this trial (administration of trial medication)
* current smokers having more than 10PYs of smoking history
* Patients needing administration of a medication which can affect asthma control such as systemic and immunoregulatory drugs (cyclosporin, omalizumab, etc.) due to a disease except asthma
Acute Effect of Resistance Exercise, Neuromuscular Electrical Stimulation, and Transcutaneous Electrical Stimulation Applications on Muscle Activation

The aim of our study is to investigate the effects of single-session resistance exercise, neuromuscular electrical stimulation, and transcutaneous electrical stimulation on the level of muscle activation and their superiority over each other on both the ipsilateral and contralateral sides. Our randomized controlled crossover study included 21 participants (13 female, 8 male, age; 27.7±4). Transcutaneous electrical stimulation was used for sensory input. A single-session application was performed only to the right extremities of all participants, and the acute effects on muscle activation on both the ipsilateral and contralateral sides were evaluated. Muscle activation was evaluated with superficial EMG. SPSS® Statistics V22.0 software was used for statistical analysis. As a result of the statistical analysis, a significant increase in activation was found only in the sensory input application group on the ipsilateral side flexor carpi radialis (FCR) (p=0.001), flexor carpi ulnaris (FCU) (p\<0.001), flexor digitorum superficialis (FDS) (p=0.023) and flexor digitorum profundus (FDP) (p=0.003) muscles. On the contralateral side, there was an increase in activation in all muscles (FCR; p\<0.001, FCU; p=0.033, FDS; p=0.017 and FDP; p=0.001) in the resistant exercise group. In addition, there was a significant increase in the activation of certain muscles on the contralateral side in the NMES application group (FCR (p=0.049) and FDP (p=0.016) muscles) and the sensory input application group (FDP (p=0.004) and FDS (p=0.043) muscles). In situations where movement is contraindicated, ipsilateral sensory input can increase the level of muscle activation through both cortical and peripheral neural mechanisms.In addition, resistance exercise to be performed on the contralateral side can be an effective application to increase muscle activation on the ipsilateral side.


Eligibility Criteria:
Inclusion Criteria:

• After providing detailed information about the study, individuals who had agreed to participate in the research were included in the study.

Exclusion Criteria:

* Individuals with any central or peripheral nervous system disease/injury affecting the upper extremity,
* Individuals with a history of orthopedic injury that could impact the study,
* Individuals with a history of neuromuscular disease, congenital anomalies, skin infections, or cognitive impairments,
* Individuals with a history of systemic or metabolic diseases that could potentially affect the study,
* Individuals with a body mass index (BMI) above 30 kg/m2.
Bed Rest and Muscle Strength in ICU: Interest in the Early Association of NEMS With Cyclo-ergometer Mobilization

Muscles atrophy and weakness are common in intensive care units, their origin is multifactorial. Passive then active mobilization with cyclo-ergometer have shown to improve functional abilities and limit muscle weakness among intensive care unit patients. Electrical muscle stimulation should limit the atrophy and muscle weakness in intensive care unit associated with early mobilization.

This study aims to compare the association early cyclo-ergometer mobilization with electrical muscle stimulation versus cyclo-ergometer mobilization only to prevent muscle atrophy and weakness in intensive care unit.


Eligibility Criteria:
Inclusion Criteria:

* Patient affiliated to a social security scheme
* Patient hospitalized in intensive care unit for medical or surgical reasons, under assisted ventilation (invasive, non-invasive ventilation or oxygen-therapy at high speed via the Optiflow(r) system delivering a flow between 30 and 60 L.min and a FiO2 between 30 and 100%)
* State of the patient deemed stable buy the doctor responsible for the care and allowing the action of the physiotherapist (acts on medical prescription)
* Age more than 18 years old (major patient) and less than 75 years old
* Duration of mechanical ventilation (invasive or not) less than or equal to 72 hours at the beginning of the inclusion
* Predicable duration of stay greater than or equal to 3 days

Exclusion Criteria:

* Impossibility to know the consent of the patient, his legal representative or the person of trust
* Patient under safeguard of justice, tutorship or curatorship
* Legionnaire not rectified
* Cardiac stimulator or defibrillator
* Cardiorespiratory state clinically not compatible withe early mobilization
* Neurological problems: intracranial pressure \> 20 mmHg, presence of ICU acquired neuropathy, pre-existing diagnosis of neuromuscular disease (MS, ALS...), acute stroke, epilepsy
* Orthopedic problems: even partial amputation of a lower limb, unstable fracture, suspicion of fracture, non-fixed spinal cord injury, use of a technique that does not allow to comply with postoperative surgical instructions (range of motion, discharge...), untreated deep vein thrombosis, traumatic sequelae to the origin of disabling manifest muscle weakness of a lower limb at admission
* Dermatological problems: severe lesions or complex dressing in the lower limbs
* Morphological criteria : size \< 1.5m, BMI \> 35
* Confirmed psychiatric illness or severe agitation
* Abdominal surgery without protection by compression belt (medical prescription), or too fragile (medical opinion)
* Pregnant or lactating women (postpartum is not an exclusion criterion)
* Patients over 75 years old
* Hemiplegia / sequential hemiparesis
* Impossibility to practice electrostimulation on at least one lower limb (manifest muscle weakness of a lower limb at admission (e. g. related to a traumatic sequelae)
The Effect of Mindfulness-Based Tai Chi Chuan on Mobile Phone Addiction Among Male College Students is Associated With Executive Functions

The goal of this clinical trial is to investigate whether an 8-week mindfulness-based Tai Chi intervention can improve cognitive and executive functions, particularly inhibitory control, and reduce mobile phone addiction in male university students. It will also explore the potential mechanisms by which mindfulness-based Tai Chi affects mobile phone addiction behaviors. The main questions it aims to answer are:

Does mindfulness-based Tai Chi improve inhibitory control and reduce mobile phone addiction in male university students? Does mindfulness-based Tai Chi enhance overall executive functions, including inhibition, updating, and shifting abilities? Researchers will compare the experimental group (receiving mindfulness-based Tai Chi intervention) to the control group (maintaining their usual routine without intervention) to see if mindfulness-based Tai Chi leads to greater improvements in cognitive and executive functions and reduces mobile phone addiction.

Participants will:

Practice mindfulness-based Tai Chi for 8 weeks Complete pre- and post-intervention assessments of mobile phone addiction, mindfulness levels, and executive function Engage in weekly Tai Chi practice sessions Complete self-report diaries of mobile phone usage and mindfulness experiences


Eligibility Criteria:
Inclusion Criteria:

* Male university students not majoring in physical education. Aged 18 years or older. A moderate level of dependence on mobile phones, with a score above 40 on the Mobile Phone Addiction Index (MPAI).

No regular exercise habits in daily academic life. Willing to participate in an 8-week mindfulness-based Tai Chi training program and provide informed consent.

No serious medical conditions.

Exclusion Criteria:

* The exclusion criteria include individuals with diseases that may affect training (such as cardiovascular diseases, respiratory diseases, and musculoskeletal disorders), as well as those diagnosed with mental disorders (such as depression, anxiety, obsessive-compulsive disorder, etc.).
NeuroSeq: A Prospective Trial to Evaluate the Diagnostic Yield of Whole Genome Sequencing (WGS) in Adult Neurology

Prospective, multi-site, single-arm study to evaluate the diagnostic yield of cWGS in adults with neurological disorders. A single cohort naive of genetic testing will receive standard of care testing for 180 days followed by cWGS. The cohort will be followed for a total of 365 days following enrollment.

This is a prospective, randomized study to evaluate the diagnostic yield of SOC compared to cWGS in each participant. Throughout this study, each participant will receive SOC testing as determined by the site clinical team. After the physician orders SOC testing during standard clinical practice, the subject will be introduced and invited to participate in the study. On Day 180, the participant will receive a cWGS result and the participant will continue to be followed for an additional 180 days. A blood sample from each enrolled participant will be collected and shipped to the Illumina Clinical Services Laboratory ("ICSL"), which is Clinical Laboratory Improvement Amendments (CLIA)-certified and College of American Pathologists (CAP)-accredited. ICSL will conduct cWGS testing with the TruGenome Undiagnosed Disease Test ("TruGenome Test"). The TruGenome Test cWGS results will be provided to the Principal Investigator (PI) or designee who will evaluate each participant's test outcome based on aggregate medical information.

Eligibility Criteria:
Inclusion Criteria:

1. Age ≥ 18 years at the time of consent
2. Participant is referred to a Neurogenetics Program due to suspected genetic etiology of a neurological syndrome
3. No history of prior genetic testing for the suspected condition in the participant or any family member with a similar phenotype
4. Must be able to have one - 4 to 6 ml tube of whole blood drawn for testing
5. Able to provide written consent. If participant unable to do so, a legally authorized representative (LAR) must do so on behalf of the participant

Exclusion Criteria:

1. Any known non-genetic cause(s) of disease, disorder, or phenotypic defect
2. Eligibility for enrollment of each participant is at the discretion of the site PI
3. Patient is unable or unwilling to undergo any form(s) of SOC genetic testing
4. SOC testing is NOT requested for the participant
Study of Genes and the Environment in Patients With Endometrial Cancer in the East Anglia, Oxford, Trent, or West Midlands Regions of the United Kingdom

RATIONALE: Studying samples of blood from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer.

PURPOSE: This study is looking at genetic susceptibility to cancer and interactions between genes and the environment in patients with endometrial cancer.

OBJECTIVES:

* To obtain epidemiological information and biological material on a population-based series of endometrial cancer cases.
* To define the proportion of endometrial cancer incidence attributable to mutations in known predisposing genes such as MSH2 and MLH1.
* To determine the risk associated with these predisposing mutations by examining the cancer risk in relatives of patients who are shown to be carriers.
* To examine the effect of nongenetic risk factors in mutation carriers.
* To determine the pathological and clinical characteristics of endometrial cancers occurring in mutation carriers as compared with that in noncarriers.
* To establish whether mutations at other loci may predispose to endometrial cancer by comparing the frequency of alterations in endometrial cancer patients with the corresponding frequency in cancer-free controls identified through the European Prospective Investigation of Cancer (EPIC) study.

OUTLINE: This is a multicenter study.

Patients complete an epidemiological questionnaire. The questionnaire will request identifying information about the patient's first-degree relatives.

Blood samples are collected from patients. DNA is extracted from these blood samples and from samples collected from cancer-free control participants in MREC-SEARCH-CONTROL as well as from additional controls through the European Prospective Investigation of Cancer (EPIC) study (a population based study of diet and health based in Norfolk, East Anglia). DNA samples are analyzed for polymorphisms of low penetrance cancer susceptibility genes.

In addition to the endometrial cancer patients recruited for this study, patients with breast, ovarian, prostate, colorectal, bladder, kidney, pancreatic, brain and esophageal cancer, malignant melanoma, and lymphoma cancer are recruited in the following related clinical trials: MREC-SEARCH-BREAST, MREC-SEARCH-OVARIAN, MREC-SEARCH-PROSTATE, MREC-SEARCH-COLORECTAL, and MREC-SEARCH-CANCER.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of endometrial cancer within the past 5 years
* Identified in any of the following geographic regions of the United Kingdom:

  * East Anglia
  * Oxford
  * Trent
  * West Midlands

PATIENT CHARACTERISTICS:

* Identified by the patient's general practitioner as fit to contact for this study
* No serious mental illness or retardation

PRIOR CONCURRENT THERAPY:

* Not specified