cyrilzakka/clinical-trials huggingface dataset:
Macular Hole Surgery With Temporal Inverted Internal Limiting Membrane Flap (MARTIAL)

Since 1991, idiopathic macular holes (MH) can benefit from an effective treatment initially involving pars plana vitrectomy, stripping of epiretinal membranes and intraocular gas tamponade followed by facedown positioning. The initial 58% success rate has further increased to 85-100% with internal limiting membrane (ILM) peeling. However, complete ILM removal has been shown to lead to anatomic changes causing the retina to have the appearance of a dissociated optic nerve fiber layer (DONFL). Moreover, it has been associated with decreased retinal sensitivity that may cause visual discomfort despite good visual acuity. Nawrocki et al. recently suggested to reduce the area of peeled ILM (temporal inverted ILM flap technique) in order to minimize iatrogenic trauma while maintaining satisfactory surgical outcomes. The aim of this study is to compare the incidence of DONFL appearance and retinal sensitivity after macular hole surgery in eyes that underwent temporal inverted ILM flap technique and eyes that had complete ILM peeling


Eligibility Criteria:
Inclusion Criteria:

* Patients older than 18 years old

Exclusion Criteria:

* Underage patients
* History of intraocular surgery (except for cataract surgery)
* Macular hole secondary to trauma, diabetic retinopathy, uveitis or associated with retinal detachment
* Concurrent macular disease (diabetic maculopathy, age-related macular degeneration)
Cognition and Emotion in the SII and IBD

The study aims at showing that the susceptibility in the stress is more raised at the person affected digestive pathologies (SII or IBD) in forgiveness than healthy subjects.

The objective of the study which we wish to lead consists in looking for, at the patients SII and IBD in forgiveness, the existence of a correlation between the rate of cortisol(Hormone of the stress) and the level of HRV (Heart Rate Variability) to estimate the inhibitive fronto-amygdalien tonus.

So we make the hypothesis that the persons affected by digestive pathologies of type SII or IBD would present an emotional and physiological vulnerability more important than unhurt subjects of pathologies.

Eligibility Criteria:
Inclusion Criteria:

* Patients with SII :Membership to the Social Security,SII defined according to the criteria Rome III.
* Patients with IBD :Membership to the Social Security,patients with a ulcerative colitis(UC) or a Crohn's disease (CD)ileal and/or colic.

Exclusion Criteria:

* Existence of a severe affectation on the general plan (cardiac,respiratory,hematological,renal,hepatic,cancerous),
* Subject diabetic,
* Pregnant or breast-feeding woman,
* Subject included in another clinical and\\or therapeutic trial or having been included in a clinical and\\or therapeutic trial for less than a month,
* Subject presenting a psychiatric pathology evident,
* Person under guardianship.
Pediatric Radial Arterial Cannulation

This prospective randomized study was designed to compare ultrasound guided technique with Doppler assisted technique for radial arterial cannulation in infant and small children.

In infants, percutaneous cannulation of radial artery requires considerable expertise. People have been using Doppler guided radial artery cannulation technique to improve success rate for more than 20 years. Recently, Ultrasound sonography has been utilized for central line placement in pediatrics. The purpose of this study is whether ultrasound guided radial artery cannulation technique improves the success rate compared to traditional doppler guided technique.

Eligibility Criteria:
Inclusion Criteria:

* Inclusion criteria

  1. Pediatric patient undergoing scheduled major surgery which require continuous arterial pressure monitoring
  2. Term neonates and children \< 4 years old weighing \>/= 3 kg and \< 12 kg

Exclusion Criteria:

* Exclusion criteria

  1. Patients with a skin wound or infection around puncture site
  2. Abnormal circulation in the hand (known vascular compromise, mottling, cool skin temp relative to other hand, poor capillary refill)
  3. Recent radial arterial puncture (less than 1 month)
  4. Any emergency surgery or profound hemodynamic instability requiring urgent arterial cannulation.
A Telehealth Advance Care Planning Intervention

The objective of this project is to conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program on healthcare communication, patient anxiety and distress, as well as completion of advance directives (specifically MOLST and healthcare proxy forms) for older patients with acute myeloid leukemia, myelodysplastic syndrome, and similar myeloid malignancies.

The Serious Illness Care Program (SICP) is an evidence-based intervention to enhance serious illness conversations between physicians and patients with advanced cancer. It consists of the Serious Illness Conversation Guide as well as training and system-level support for clinicians to conduct serious illness conversations. The investigators have previously adapted the SICP to be delivered via telehealth for older adults with myeloid malignancies. In this study, they will conduct a pilot randomized trial to assess the preliminary efficacy of a telehealth-delivered Serious Illness Care Program compared to an education control.

Eligibility Criteria:
Inclusion and Exclusion Criteria for Patients

Inclusion criteria:

* Age ≥60 years
* A diagnosis of AML, MDS, and similar myeloid malignancies (including but not limited to MDS/MPN overlap syndrome, myelofibrosis)
* Being managed in the outpatient settings
* Able to provide informed consent
* English-speaking

Exclusion criteria:

- None

Inclusion and Exclusion Criteria for Caregivers

Inclusion criteria:

* Age ≥18 years
* Selected by patient when asked if there is a "family member, partner, friend, or caregiver with whom you discuss or who can be helpful in health-related matters"
* Able to provide informed consent
* English-speaking

Exclusion criteria:

- None

Inclusion and Exclusion Criteria for Oncology Providers

Inclusion criteria:

- Oncologists and/or APPs who will be conducting the telehealth-delivered ACP visit

Exclusion criteria:

- None
The Impact of Dietary Restriction of Animal Protein and Fat on Osteoarthritis

Patients will be randomized into the control or intervention group. Based on patient preference, the intervention group will be trained for one hour in either individual or group format on vegan diet. They will also be directed to www.pcrm.org and www.drmarymd.com for low glycemic, animal free, low fat food options and support. The control group will continue their normal omnivorous diet program. Twenty-four hour food recalls will be obtained at the start and end of the trial, and once a week for the 6 weeks of the trial by telephone. Patients will undergo a final interview at the end of the 6 week study period. The intervention group should strive to obtain 90% of their calories from plants. They will be encouraged to eat freely and not count calories. Patients will undergo additional individual consultation as needed to promote compliance and answer specific questions.

Over the 6 weeks, the Patient Global Improvement of Change (PGIC) and the 36 item short form health survey (SF-36) will be performed weekly by telephone. Patient will perform a Visual Analog Scale (VAS) of their pain level randomly daily on their own. C-reactive protein levels will be assessed at the beginning and end of the study at Munson Medical Center Laboratories as a secondary measure of diet changes.

There have been no published prospective randomized controlled trials assessing whether a vegan diet would benefit osteoarthritis. The specific aim of this study is to determine if a vegan diet will result in subjective reduction in perceived pain and limitations to function in patients with osteoarthritis.


Eligibility Criteria:
Inclusion Criteria:

* Community dwelling
* Medical Provider diagnosis of Osteoarthritis

Exclusion Criteria:

* Pre-existing vegans or vegetarians
* Ages less than 18 or greater than 70
* History of an eating disorder
* History of diabetes
* Inability to afford food
* Lack of control over the food eaten
* Pregnant or nursing
* Known food allergies
* Patients following a medically prescribed diet
Prospective Study of Persistent Dyspnea in Recovered COVID-19 Patients

We conducted a national, single center (Hospital Clínico Universitario de Valladolid, Spain, Valladolid), prospective study of patients with prior hospitalization because of COVID-19 who were admitted between March 1st, 2020, and May 15th, 2020. All eligible patients underwent at least at first-time follow-up from the index event. Exclusion criteria were age \< 18 years old, pregnant women, terminally ill patients, active SARS-CoV-2 infections, inability to exercise and previous known severe pulmonary or heart disease. Patients underwent a clinical assessment for symptom burden, questionnaire for quality of life (Kansas City Cardiomyopathy Questionnaire and SF-36), venous blood sampling, 6-minute walking test (6-MWT), tests of lung function (spirometry and diffusing capacity of the lungs for carbon monoxide) and treadmill cardio-pulmonary exercise testing (CPET). 48-hours before the test of lung function and the CPET, all patients yielded a negative result in the reverse transcription-polymerase chain reaction (RT-PCR) for SARS-CoV-2. For definitive analysis patients were assigned to the control group if they did not refer dyspnea at the time of the follow-up, a small asymptomatic out-patient control group without prior hospitalization was also included.


Eligibility Criteria:
Inclusion Criteria:

* Signed Informed Consent
* Previous COVID-19 hospitalization with successful discharged
* Availability of at least one follow up per clinical protocol

Exclusion Criteria:

* pregnant women
* terminally ill patients
* active SARS-CoV-2 infections
* inability to exercise
* previous known severe pulmonary or heart disease
A Study of KCT-0809 in Patients With Dry Eye Syndromes

The purpose of this study is to evaluate the efficacy and safety of KCT-0809 compared to placebo in patients with dry eye syndromes.


Eligibility Criteria:
Inclusion Criteria:

* Corneal and conjunctival damage
* Insufficiency of lacrimal secretion or tear film instability
* Ocular symptom

Exclusion Criteria:

* Severe ophthalmic disorder
* Punctual plugs or surgery for occlusion of the lacrimal puncta
Early Caries Lesion Management Observational Study

The purpose of this observational study is to assess the effectiveness of Curodont Repair Fluoride Plus (CRFP) compared to other tooth-specific treatments (silver diamine fluoride (SDF), sealants, or other FDA-approved treatments) in preventing progression to cavitation in patients with at least one early non-cavitated dental caries lesion.

The study will also evaluate the effectiveness of CRFP in comparison to no tooth-specific treatment control groups, including whole mouth treatments such as: 2.26% fluoride varnish, 1.23% fluoride foam, and 5000 ppm fluoride prescription toothpaste; and no treatment, on caries arrest and in preventing progression to cavitation in patients with at least one early non-cavitated dental lesion.

Study subjects will be enrolled upon diagnosis of at least one ADA Caries Classification system "initial" caries lesion. Subjects will be further sorted into study cohorts based on the non-invasive treatment option they select. The early lesions will be followed for 24 months after the date of the initial caries lesion diagnosis or the date of the first non-invasive treatment applied to the lesion.

Patients who choose CRFP will serve as the primary variable of interest. The primary objective is to assess the effectiveness of CRFP compared to other tooth specific treatments (SDF, sealants, or other FDA-approved treatments) in preventing progression to cavitation in initial dental lesions. The primary endpoint will be measured by the percentage of patients that require operative treatment for at least one early lesion noted at baseline during the following 24 months of observation.

The secondary objectives are to assess the effectiveness of CRFP compared to no tooth-specific treatment (including whole mouth treatments such as: fluoride varnish, fluoride foam, prescription toothpaste; other FDA-approved treatments; and no treatment) on 1.) caries arrest and 2.) preventing progression to cavitation in patients with at least one early dental lesion. The secondary endpoints will be measured by 1.) the percentage of patients that have caries arrest for at least one early lesion noted at baseline during the following 24 months of observation and 2.) the percentage of patients that require operative treatment for at least one early lesion noted at baseline during the following 24 months of observation.

Eligibility Criteria:
Inclusion Criteria:

* All patients with permanent teeth who are diagnosed with at least one American Dental Association Caries Classification System (ADACCS) "Initial" caries lesion in a permanent tooth, will be included in this analysis.

Exclusion Criteria:

* Primary teeth
* Permanent teeth with ADACCS "Moderate" or "Advanced" caries lesions
* Healthy/ ADACCS "Sound" teeth
An Open Label Placebo Study to Assess the Inhalation Profile in Asthmatic Patients Using the Nexthaler® Dry Powder Inhaler (DPI) Device

Phase IIa, single-centre, open-label, single-arm study, to evaluate the inspiration profile through the NEXThaler® device in adult asthmatic patients with varying degrees of disease control.

The primary objective of this study is to assess the inspiratory flow profile through the NEXThaler® device in adult asthmatics with varying degrees of disease control.

The study plan foresees one visit at clinic. At Visit 1, after the signature of the informed consent form, the inclusion/exclusion criteria will be checked and the lung function parameters will be evaluated. If the subjects meet the inclusion/exclusion criteria, they will be instructed to use the NEXThaler®. The patients will subsequently inhale through the device and the inspiration profile will be measured.

A total of 40 asthmatic adults (≥18 years), 20 with controlled stable disease and 20 with partly controlled or uncontrolled disease according to GINA guidelines (2011), will be enrolled.

Eligibility Criteria:
Inclusion Criteria:

* Clinical diagnosis of controlled, partly controlled or uncontrolled asthma according to GINA guidelines (2011)
* A cooperative attitude and ability to use DPIs and to be trained in the proper use of the NEXThaler® as confirmed by the activation of the training device BAM

Exclusion Criteria:

* Significant seasonal variation in asthma or asthma occurring only during episodic exposure to an allergen or a chemical sensitizer
* History of near fatal asthma (e.g. brittle asthma, hospitalisation for asthma exacerbation in Intensive Care Unit)
* Diagnosis of restrictive lung disease
* Significant unstable medical history of and/or treatments for cardiac, renal, neurological, hepatic, endocrine diseases, or any laboratory abnormality indicative of a significant underlying condition, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion.
Study of Botulinum Toxin Type A (BOTOX®) to Treat Urinary Incontinence From Neurogenic Detrusor Overactivity in Belgium

This study will evaluate the impact of BOTOX® treatment on anticholinergic drug use in patients with urinary incontinence from Neurogenic Detrusor Overactivity (NDO) due to spinal injury or Multiple Sclerosis (MS) who are prescribed BOTOX® as standard of care in clinical practice.


Eligibility Criteria:
Inclusion Criteria:

* Patients prescribed BOTOX® for urine incontinence from NDO due to spinal injury or MS as standard of care in clinical practice in Belgium
* Previous treatment with anticholinergic drugs ineffective
* Last BOTOX® treatment ≥18 months.

Exclusion Criteria:

* Diagnosis of urinary incontinence less than 9 months.
* No anticholinergic drug use in the last 9 months.
Predictors of Muscle Injury Risk in Non-professional Football Players

Background. Football accounts for 30% of all sports injuries. Muscle injuries in football are the most common non-traumatic and non-contact injuries. A comprehensive approach to injury prevention must consider the design of the footwear and the environmental conditions in which the match is played.

Objective. To assess the risk of injury as a function of footwear and field of play in non-professional football players and to identify the best predictive model of muscle injury in these athletes.

Method. Ambispective cohort study. Ninety-seven players will be recruited. The primary variable will be the number of lower limb muscle injuries in the last 3 seasons. Secondary and modifying variables will be: age, body mass index, boot type, pitch turf, training load and field position. Potential confounding variables will be motivation for choice of footwear, date of muscle injuries, time playing in the category and presence in the starting team. The analysis will calculate the risk of adverse effects in these patients and assess the influence of confounders and trend analysis on the primary variable, stratified by potential confounders.

Expected outcomes. To calculate the risk of muscle injury as a function of anthropometric variables, and footwear and turf type. To identify the predictive model of muscle injuries in football players.


Eligibility Criteria:
Inclusion Criteria:

* Federated, non-professional football players.
* Competing in category 3 RFEF (group 2).
* Who compete in the territorial delimitation of the Principality of Asturias.
* Subjects who have not undergone previous musculoskeletal surgery in the seasons under study.
* Who were federated at least one year before the study period.

Exclusion Criteria:

* Players who have not participated in competition, during the seasons under study, for a period of more than 6 months due to a musculoskeletal injury.
Treating Sleep Apnea Induced Hypoxemia With Oxygen in Acute Stroke Patients

We want to determine if treating acute ischemic stroke patients who have evidence of hypoxemia due to sleep apnea with low flow O2 during sleep might help improve clinical and functional outcomes.

Acute stroke patients will be tested for nocturnal hypoxemia using overnight oximetry. Those with evidence of hypoxemia will be randomized into two groups. One group will receive standard medical care. The other group will receive standard medical care as well as receiving low flow oxygen during sleep.

Eligibility Criteria:
Patients presenting to Mayo Clinic Hospital with acute ischemic stroke
Non-invasive Characterization of Systemic Microvascular Reactivity by Near-infrared Diffuse Optical Spectroscopy in COVID-19 Patients

The purpose of this study is to characterize microvascular reactivity on the forearm muscle using non-invasive near-infrared spectroscopy in critically ill COVID-19 patients, and to correlate its alterations with 28-day mortality in ICU COVID-19 patients.

After giving consent to participate in the study, the subjects included in the study will undergo a 15-minute measurement of tissue oxygen saturation (StO2) measured non-invasively on the forearm by means of near-infrared spectroscopy (NIRS). Once a baseline stable StO2 value is obtained, a provocative test, consisting of a transient vascular occlusion, will be performed. The test will allow the obtention of a local metabolic rate, and a StO2 recovery rate after the ischemic stimulus. This StO2 recovery rate will be considered as a reflection of the endothelial health of the patient.

Patients will be studied as soon as possible after admission to the ICU, and followed-up until ICU discharge or death.

Eligibility Criteria:
Inclusion Criteria:

* Recent diagnosis of SARS-CoV2 infection
* Arterial hypoxemia and bilateral alveolar infiltrates, not explained by cardiac dysfunction or fluid overload.

Exclusion Criteria:

* Severe peripheral vasculopathy
* Raynaud's syndrome
* Skin lesions or trauma in upper limbs interfering the placement of NIRS probe and/or the occlusion tourniquet
* Deep venous thrombosis in the upper limbs
Scale Down for Endometrial Cancer

This proposal will pilot a weight management program for patients with endometrial cancer, the cancer most associated with obesity. If successful, this pilot could be expanded to include obese women with other gynecologic cancers (ovarian and cervical) and could be expanded and adapted for use not only upon completion of treatment, but during chemotherapy or radiation. Furthermore, other obstetricians and gynecologists could use this strategy for obese women as a practical cancer prevention strategy for obesity-associated cancers.


Eligibility Criteria:
Inclusion Criteria:

* Female women 18 years of age or older and with biopsy-proven endometrial cancer.
* BMI greater than or equal to 30 kg/m\^2.
* Must be able to read and speak English.
* All patients must be informed of the investigational nature of this study and must sign and give written informed consent for Aim 1 study activities in accordance with institutional and federal guidelines.
* Has completed prior surgical management and adjuvant endometrial cancer treatment, if adjuvant treatment is indicated, prior to starting Aim 1.
* Is not receiving concurrent cytotoxic chemotherapy and/or radiation therapy at time of enrollment AND, if randomized, is not anticipated that the participant will need to receive concurrent cytotoxic chemotherapy and/or radiation therapy at any time during the Aim 1 intervention
* Patients with BMI greater than or equal to 30 kg/m\^2 who are undergoing hormonal treatment of endometrial cancer.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2
* Life expectancy of at least one year
* Must have a phone capable of receiving text messages.

Exclusion Criteria:

* Females under the age of 18 years
* BMI less than 30 kg/m\^2
* Must not be participating in another formal weight loss program.
* Must not have any other clinically significant medical disease or condition that, in the Investigator's opinion, may interfere with protocol adherence or a participant's ability to give informed consent.
* For participants who are randomized in Aim 1:

  * No uncontrolled serious medical or psychiatric condition(s) that would affect the patient's ability to participate in the interventional study, e.g., uncontrolled hypertension, symptomatic cardiac disease, or severe/uncontrolled depression as indicated by a previously completed Patient Health Questionnaire (PHQ-9) score \>9 (Kroenke)
  * No diagnoses of any other invasive malignancy other than endometrial cancer or non-melanoma skin cancer which required active treatment currently or within the last 2 years.