cyrilzakka/clinical-trials huggingface dataset:
Ventilator Induced Diaphragm Dysfunction in Pediatric Critically Ill Patients (VIDD)

evaluation of diaphragmatic disfunction eventually occurred in pediatric patient undergoing mechanical ventilation therapy

Physician will perform US diaphragm measurements within 36 hours of initiation of MV. Measurements will be repeated daily for the duration of MV for the first week, then every 48 hours and 24 hours after the extubation.

Exposure to and duration of continuous NMBA infusion during the course of MV and use of CS will be recorded.

Ventilator logs and arterial gas analysis will be checked at the time of each US measurement to ascertain ventilator settings and SBF for the 24 hours preceding each US measurement.

Extubation success will be defined as no requirement for reintubation within 48 hours following extubation. The use of NIV immediately after extubation will be decided by the physician in charge according to the patient clinical history (presence of withdrawal syndrome, ect) and NOT according to DTF measurement.

Eligibility Criteria:
Inclusion Criteria:

* patients younger than 18 years old
* expected clinical requiring of invasive MV for more than 36 hours

Exclusion Criteria:

* neonates
* subjects with preexisting diagnoses of neuromuscular weakness
* diaphragm paresis
* chronic respiratory failure with ongoing requirement for invasive MV, or continuous positive airway pressure (CPAP) or bilevel positive airway pressure (BiPAP) or with likely death within 48 hours.
High Intensity Functional Image Guided Vmat Lung Evasion

This study is being performed to assess the feasibility of adapting radiotherapy plans based on functional lung information and increasing the dose to the primary tumour. This is a single arm interventional pilot study involving 20 patients.

Aims Primary: to assess the feasibility of using ventilation and perfusion positron emission computed tomography (V/Q PET/CT) scans to adapt radiotherapy plans using Volumetric Modulated Arc Therapy (VMAT) to avoid regions of functional lung and deliver a higher dose to the primary tumour Secondary: to assess the incidence of acute and late radiotherapy toxicities, to quantify regional ventilation loss and regional perfusion loss on post treatment V/Q PET/CT, to assess associations of V/Q PET/CT with other functional lung imaging techniques, to assess overall survival, progression free survival and quality of life outcomes.

Participants: 20 patients stage IIIa-c non-small cell lung cancer for curative intent radiotherapy.

Methods: All patients will receive functional lung adapted 60 Gray (Gy) in 30 fractions to the primary and nodal planning target volume with a simultaneous integrated boost to the primary tumour to a total dose 69Gy in 30 fractions.

Expected outcomes: That functionally adapted lung radiotherapy using V/Q PET/CT imaging and VMAT planning is technically feasible.


Eligibility Criteria:
Inclusion Criteria:

* Age ≥ 18 years;
* Written informed consent has been provided.
* Histologically or cytologically confirmed Non-Small Cell Lung Cancer
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2 within 2 weeks prior to registration
* Locally advanced disease (stage IIIA, IIIB, IIIC as per American Joint Committee on Cancer AJCC, 8th ed.) as confirmed on staging 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose (FDG) PET/CT
* No evidence of metastatic intracranial disease on CT brain with contrast or MRI
* Willing to participate in the full follow up schedule
* Planned for treatment with curative intent

Exclusion Criteria:

* Participant is not able to tolerate supine position on PET/CT bed for the duration of the PET/CT acquisitions, is not cooperative, or needs continuous nursing (e.g. patient from Intensive Care Unit) or is unable to attend full course of follow up visits
* Pregnancy or Breast-feeding
* If history of a prior extra thoracic invasive malignancy (except non-melanomatous skin cancer) must be free from recurrence for a minimum of 3 years at the time of registration
* Prior radiotherapy to the lungs or mediastinum (a history of prior breast radiotherapy is not an exclusion)
* Prior known history of interstitial lung disease \* A history of renal impairment or reaction to iodine contrast is not an exclusion criteria, if a patient has medical comorbidities that exclude the use of iodine contrasts, these exploratory investigations can be omitted.
Transcranial Magnetic Stimulation and Perioperative Neurocognitive Disorders

To investigate the impact of rTMS on the incidence of perioperative neurocognitive disorders in patients after after cardiac surgerysurgery. To explore the underlying mechanisms behind the efficacy.

There is a relatively high incidence of perioperative neurocognitive disorders（PND） after surgeries, and the incidence is even higher in the geriatric population undergoing cardiac surgery. Nevertheless, there remains no effective medication or intervention been approved in PND. It has been shown that brain stimulation can improve cognitive function in mild cognitively impaired patients. However, the effects on cognitive function in PND remain uninvestigated.

Eligibility Criteria:
Inclusion Criteria:

* 1. Age 18 years or older.
* 2. ASA class I - III, patients undergoing elective cardiac surgery(coronary artery bypass grafting, aortic or mitral valve surgery).
* 3. Sign the informed consent.
* 4. Able to complete follow-up visits.

Exclusion Criteria:

* 1. A history of psychopathology and/or taking medication.
* 2. Previous history of neurological disease.
* 3. Severe organic diseases.
* 4. RTMS contraindications (such as a history of epileptic seizures, metal implants near the head).
* 5. Having delirium, assessed by CAM, before surgery.
* 6. Participating in other clinical studies at the time of screening.
* 7. Having a cardiopulmonary arrest and cardiopulmonary resuscitation.
* 8. Having short-term second operation.
A Pilot Study to Evaluate Safety and Efficacy of CigRx™ in Smokers

A randomized, double-blind, active-controlled, crossover, pilot study to evaluate the safety and efficacy of CigRx™ Lozenge, a dietary supplement, in daily smokers in temporarily reducing the desire to smoke

Subjects will orally self-administer 2 study products, each in the form of a dissolvable lozenge, and will complete questionnaires on demographics, urges to smoke, and product rating.

Eligibility Criteria:
Inclusion Criteria:

* Healthy adult smokers
* Smoking for at least 5 years
* Smoking at least one (1) pack of cigarettes a day

Exclusion Criteria:

* Allergy to lozenge components
Quality of Life After Esophagectomy for Cancer - Step 1

Background: A recent systematic review showed that patients undergoing esophagectomy for cancer had scores of physical function, vitality and performance of health in general significantly lower than those obtained from the reference population. The analysis of the quality of life at six months follow-up showed that the total score and physical function were better before surgery and symptoms-based scales indicated that the fatigue, dyspnoea and diarrhea were worse six months after esophagectomy. The objective of this study is therefore to assess the impact of esophageal resections for cancer on the quality of life of patients and to improve it through simple interventions of post operative care.

The study is divided into two steps.

This is step 1.

Patients will be randomized into four groups receiving respectively: psychological counseling for support plus appropriate measures to reduce sleep-wake rhythm disorders during ICU stay; psychological counseling alone; appropriate measures to reduce sleep-wake rhythm disorders during ICU stay alone; or standard care. The primary end point are the items SL (sleep disorder) and QL2 of the QLQ C30, and the secondary end point is the score of the PSQI.


Eligibility Criteria:
Inclusion Criteria:

* age above 18 years old
* scheduled for esophagectomy for cancer

Exclusion Criteria:

* age below 18 years old
* incapability to autonomously fill in questionnaires
* primary language not italian
Patient Retrospective Outcomes (PRO)

This study will evaluate de-identified (anonymous) data in subject medical charts to review the clinical outcomes of various treatment approaches in the treatment of chronic pain.

This study is a retrospective, multi-center, de-identified patient data review.

The study will include multiple independent cohorts to evaluate clinical outcomes in different subgroups.

Eligibility Criteria:
Key Inclusion Criteria:

* Previously treated with or eligible for use with Boston Scientific Systems
* 18 years of age or older at the start of Baseline
Left Ventricular Function After Primary Percutaneous Coronary Intervention: Role of Speckle Echocardiography

Recovery of the left ventricular function is variable from one patient to another, thus assessment of cardiac function by measuring left ventricular ejection fraction using echocardiography is the most common in the daily clinical practice. However, this technique has limitation related with its intra- and interobserver variability. A recent technique, 2D speckle tracking for assessing global longitudinal strain, has been introduced to reduce the variability and potentially has a higher accuracy. Speckle tracking is a method which uses two dimensions recording for measuring quantity of movement of myocardium in several segments.

Speckle-tracking echocardiography is a current noninvasive ultrasound imaging technique that allows for an objective and quantitative evaluation of global and regional myocardial function independently from the angle of insonation and from cardiac translational movements,

Authors using 2D speckle tracking found that subclinical LV systolic dysfunction is common in patients with isolated severe mitral stenosis (MS) and is determined primarily by the hemodynamic variables of MS severity and reduced LV filling. BMV results in rapid recovery of LV systolic function in these patients through improvement in LV diastolic loading. These findings suggest that LV contractile properties in MS are modulated predominantly by LV diastolic filling rather than myocardial structural abnormality.

Eligibility Criteria:
Inclusion Criteria:

* Patients with acute myocardial infarction eligible for PCI seen on admission and after 40 days

Exclusion Criteria:

* cardiomyopathy
* cancer
* on cytostatic treatment.
Vitamin D Analog in Vitamin D 24-hydroxylase Deficiency

Preclinical evaluation of a vitamin D analog for the treatment of vitamin D 24-hydroxylase using fibroblast from patients with CYP24A1 mutation.


Eligibility Criteria:
Inclusion Criteria:

* biallelic mutation in CYP24A1
* consent

Exclusion Criteria:

* none
Pilot Study of Virtual Reality Therapy for Students With Anxiety

The purpose of this study is to assess changes in self-reported anxiety over the course of six virtual reality (VR) sessions and to assess changes in academic self-efficacy, as well as examine the feasibility and acceptability of a relatively short and time intensive VR intervention (i.e.,six sessions over the course of three weeks) for reducing anxiety symptoms in college students.


Eligibility Criteria:
Inclusion Criteria:

* enrolled in The University of Texas Health Science Center School of Public Health San Antonio regional campus
* competent in English
* total score of at least 3 on the Generalized Anxiety Disorder (GAD-2)

Exclusion Criteria:

* Currently receiving psychological treatment for anxiety symptoms, or has received treatment in the last year.
* Report photosensitive epilepsy.
* Report stereoscopic vision or balance problems
Adhesive Tape Trauma Evaluation of Two Gentle Tapes

The objective of this study is to determine the relative gentleness of two tapes recognized for gentleness. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.

The objective of this study is to determine the relative gentleness of a new investigational tape compared to 3M Micropore tape, a gold standard tape recognized for its gentleness and used as a mainstay in cosmetic surgery and neonatal care. A three-prong multidimensional evaluation consisting of laboratory assessments, expert skin grader and subject discomfort assessment will be used.

Eligibility Criteria:
Inclusion Criteria:

1. Who are healthy and who have intact skin at the test site with a baseline score of 0 for erythema
2. Who are between the ages of 6 months - 4 years of age
3. Who has a Fitzpatrick Skin Type of I, II or III
4. Subject who's parent agrees to not use any products (i.e. topical medications, creams, powders or ointments) on the test sites for 24 hours prior to the study start date
5. Whose parent is willing to sign the Informed Consent Form.

Exclusion Criteria:

1. Who are known to be developmentally delayed
2. Who have sunburn, skin infection or scars, moles, or other blemishes on the back that would obscure grading of the test sites
3. Who have had any exposure to other topical medications, creams, powders, or ointments on the test sites 24 hours prior to the start of the study.
4. Who have had a strep infection within the past 2 weeks
5. Who have a history of diabetes, psoriasis, any active dermatitis, or recent history of dermatitis or skin reactions
6. Who have allergies to isocyanates, or acrylate adhesive products
7. Who currently take any antihistamines or anti-inflammatory medication or who have taken any of these medications within 48 hours prior to the start of the study or does not agree to refrain from taking these medications for the 48 hours prior to the start of the study and for the duration of the study (Tylenol is an acceptable pain reliever).
Correlation Between Friedman Classification and the Apnea Hypopnea Index (AIH) in a Population With Obstructive Sleep Apnea Syndrome (OSAS)

Introduction:

OSAS is an important disease in the actual medic scene. It is important for correlation with chronic cardiovascular disease that leaves an increase in morbimortality and socioeconomic disability to patients with apnea.

Objectives:

Determinate the correlation between Friedman Classification and the obstructive sleep apnea syndrome (OSAS) gravity through AHI (Apnea Hypopnea Index) in patients with OSAS for surgical indication and evaluation.

Materials and Methods:

The investigators evaluated and classified 84 patients, in the scale of Epworth, Friedman and how much the gravity of the SAHOS for the AHI.


Eligibility Criteria:
Inclusion Criteria:

* Not exhibiting any exclusion criteria
* Age \> 21 years

Exclusion Criteria:

* Nasal tumor
* BMI \> 40
* No acceptance of study
* Nasal poliposis
CovidDB: The Covid-19 Inpatient Database

The aim of the project is to better understand the Covid-19 inpatient course of the disease and to quickly identify the positive experiences in the treatment in order to update guidelines for the treatment and use of medication.

The exponentially increasing number of SARS-CoV-2 infected people, despite the influence of the currently existing non-medical measures, is generating a rapidly increasing number of inpatients, some of whom need artificial ventilation. The average focus is on the extent to which the hospitals' capacities will be sufficient to adequately treat all patients. Regardless of this, it can be expected that even if the non-medical measures are successful, the number of inpatients treated will remain high in the course of the pandemic. With regard to the distribution of infection, it can be expected that clinics with a wide range of expertise will have to treat a large number of Covid-19 patients.

So far, however, there is little to no experience in treating patients. In addition to epidemiological data, only case descriptions and some Chinese studies mostly from Wuhan based on fewer patients are available. In view of the rapidly spreading pandemic, preprints are increasingly being used. What has been missing so far is a uniform, structured recording of the courses of Covid-19 inpatients handled by many clinics, which goes beyond the epidemiological events in terms of depth of detail. With this documentation of real processes, the basis for a large number of studies and the associated better understanding of the disease process could be created.

The current dynamics make it imperative that the clinics, even those who have not received the most up-to-date scientific knowledge, cannot wait for the results of studies, but rather need concrete help in the treatment of patients. Efficient assistance within the framework of a close exchange between the treatment units is only possible with a multicentre, uniform documentation environment.

The aim of the project is to better understand the Covid-19 inpatient course of the disease and to quickly identify the positive experiences in the treatment in order to update guidelines for the treatment and use of medication.

Eligibility Criteria:
Inclusion Criteria:

* Covid-19 inpatients

Exclusion Criteria:

* assumed Covid-19 patient
Efficacy and Safety of Remo-Wax for Removal of Impacted Earwax

The study evaluates if Remo-Wax ear drops can soften impacted earwax.

This is an open, single-arm multicentre study to confirm the efficacy and safety of a commercially available Remo-Wax ear drops containing allantoin for dissolving and removing impacted earwax. Subjects that qualify for enrollment and provide informed consent wil be treated with topical earwax softening product.

Eligibility Criteria:
Inclusion Criteria:

1. Written informed consent obtained.
2. Male or female patients over 1 year old who have cerumen impaction.
3. Presence of excessive or impacted cerumen \[excessive or impacted cerumen is identified as causing partial (\> 50%) or complete occlusion of at least one ear canal when attempting to visualize the tympanic membrane.

Exclusion Criteria:

1. Hypersensitivity to any product ingredient(s) or history of anaphylactic/anaphylactoid reactions.
2. History of tympanic membrane perforation, tympanostomy tubes, or otitis externa in the previous 6 months.
3. External ear infection.
4. Middle ear infection
5. Past ear surgery.
6. Otorrhea.
7. Temporal bone neoplasm.
8. Presence of known or suspected mastoiditis.
9. Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data (e.g. ear eczema or seborrhoea, ear canal stenosis, exostoses).
10. Deafness in the contralateral ear (single sided deafness).
11. Use of any ototopical drug or cerumen-removal product (with the exception of water or physiologic saline) during the preceding 3 days.
12. Use of hearing aids.
13. Participation in another drug study within 60 days prior to the start of the present study.
14. Predictable poor compliance or inability to communicate well with the investigator.
Study to Assess the Effect of Long-term Treatment With Voxelotor in Participants Who Have Completed Treatment in Study GBT440-031

Open Label Extension Study of Voxelotor Clinical Trial Participants with Sickle Cell Disease Who Participated in Voxelotor Clinical Trials

This open label extension (OLE), multi-center study will be conducted at approximately 100 clinical sites globally and will be available to eligible participants from study GBT440-031.

The study will enroll participants from GBT440-031 (approximately 435) under any of the following conditions:

* Participant has completed 72 weeks of treatment regardless of dose selection for GBT440-031
* Dose selection has occurred for GBT440-031 and participant is on non-selected dose on GBT440-031
* GBT440-031 study interim data analysis and/or study modifications have occurred
* GBT440-031 study has completed

The objective of this open-label extension (OLE) study is to assess the long-term safety and treatment effect of voxelotor in participants who have completed treatment in study GBT440-031, using the following parameters:

1. Safety based upon AEs, clinical laboratory tests, physical examinations (PE) and other clinical measures.
2. Frequency of sickle cell disease (SCD)-related complications.
3. Hemolytic anemia as measured by hematological laboratory parameters (e.g. hemoglobin, reticulocytes and unconjugated bilirubin).

All participants will receive daily voxelotor treatment.

Participants may receive study drug as long they continue to receive clinical benefit which outweighs risk as determined by the Investigator and/or until the participant has access to voxelotor from an alternative source (i.e., commercialization or through a managed access program).

Eligibility Criteria:
Inclusion Criteria:

* Male or female study participants with SCD who participated and received study treatment in Study GBT440-031.

Note: Participants in GBT440-031 who discontinued study drug due to an AE, but who remained on study may be eligible for treatment in this study provided the AE does not pose a risk for treatment with voxelotor.

* Females of child-bearing potential are required to have a negative urine pregnancy test prior to dosing on Day 1.
* Female participants of child-bearing potential must use highly effective methods of contraception to 30 days after the last dose of study drug. Male participants must use barrier methods of contraception to 30 days after the last dose of study drug.
* Participant has provided written informed consent or assent (the ICF must be reviewed and signed by each participant; in the case of pediatric participants, both the consent of the participant's legal representative or legal guardian, and the participant's assent must be obtained).

Exclusion Criteria:

* Female who is breast-feeding or pregnant.
* Participant withdrew consent from Study GBT440-031.
* Participant was lost to follow-up from Study GBT440-031.
* Participant requiring chronic dialysis.
* Any medical, psychological, safety, or behavioral conditions, which, in the opinion of the Investigator, may confound safety interpretation, interfere with compliance, or preclude informed consent.
South American Thoracic Stent-Graft Study

A prospective, non-randomized multi-center clinical evaluation of the performance of the TriVascular Thoracic Stent Graft System when used in the treatment of subjects with thoracic aortic aneurysms (TAA).


Eligibility Criteria:
Inclusion Criteria:

* The TriVascular Thoracic Stent Graft System is indicated in subjects diagnosed with an aneurysm in the descending thoracic aorta having vascular morphology suitable for endovascular repair, including:

  * Adequate iliac/femoral access compatible with the required delivery systems,
  * Non-aneurysmal aortic segments proximal and distal to the aneurysm.