cyrilzakka/clinical-trials huggingface dataset:
Mechanical Ventilation Controlled by the Electrical Activity of the Patient's Diaphragm - Effects of Changes in Ventilator Parameters on Breathing Pattern

Neurally adjusted ventilatory assist (NAVA) is a new concept of mechanical ventilation. NAVA delivers assist to spontaneous breathing based on the detection of the electrical activity of the diaphragm. We study the effect of changing ventilatory parameters on the patient's breathing pattern during NAVA.


Eligibility Criteria:
Inclusion Criteria:

* Invasive mechanical ventilation (tracheally intubated or tracheotomized)
* Presence of an arterial pressure line.
* Subject itself or its next of kin has given written informed consent

Exclusion Criteria:

* Patient is less than 18 years or more than 85 years of age
* The attending physician refuses to allow enrollment
* The patient refuses informed consent
* Next of kin is unavailable or refuses informed consent
* Pregnant or breast-feeding female. A pregnancy test will be performed in all female patients less than 60 years of age.
* Any contraindication to insertion/exchange a nasogastric tube, including (but not limited to): severe oropharyngeal malformation or bleeding; esophageal varices, tumor, infection, stenosis, or rupture
* Presence or suspicion of diaphragm injury
* Hemophilia or other severe bleeding disorder
* Presence or suspicion of a central nervous system (CNS) disorder, including (but not limited to): CNS infarction, bleeding, tumor, or infection
* History of heart and/or lung transplantation
* Any mechanical cardiac assist device (excluding intraaortic balloon pump)
* Any contraindication to reduce sedation or to stop neuromuscular blockage in order to allow spontaneous breathing
* The patient needs to be ventilated with a mode of mechanical ventilation that targets a predefined tidal volume or airway pressure as per attending physician
* Severe hemodynamic instability as per attending physician
* Planned or anticipated intervention within the study period necessitating either transfer out of the ICU or requiring prolonged interaction with the patient.
* A fraction of inspired oxygen (FiO2) of \> 0.8
* The patient currently participates in another interventional clinical trial
Patient Centered Results for Uterine Fibroids

The overall goal of this project is to better enable patients with uterine fibroids (UF) to make informed decisions about treatment options by leveraging the highest possible evidence of healthcare quality. The foundation of this project will be a multi-site, prospective registry of a diverse group of women who have undergone either medical or surgical treatment for UF.

Specifically, the investigators are interested in: comparing management options for symptom relief; comparing management options for preserving reproductive function; and comparing effectiveness among different subpopulations, including consideration of patient needs and preferences of treatment options.

COMPARE UF will enroll approximately 10,000 subjects across 9 clinical enrolling centers in the US. We anticipate recruitment to last approximately 24 months. Sites will consent interested patients and have them complete a patient contact information form to be used to contact the patient for telephone interviews. Following informed consent, the site will collect clinical information and several patient-reported outcomes scales, including the Uterine Fibroid Symptom Quality of Life Questionnaire (UFS-QOL), the Menopausal Rating Scale, and the EQ-5D, a standardized measure of general health outcomes.

In year 01 of this study, among patients receiving a procedure to treat their UF, 1000 will be asked to provide two blood samples: the first at time of enrollment (before the procedure) and the second at 12 months after the procedure. Samples will be evaluated for ovarian reserve via a blood assay measurement of anti-mullerian hormone.

Additionally, for patients who have a procedure to treat their UF, they will have a routine clinic follow-up visit, sometime between 6 - 12 weeks post procedure. Additional clinical data will be collected at this time.

For patients who are treated medically, there will be no further study-related clinic visits. Follow-up will occur exclusively by telephone.

All consented patients will complete telephone interviews at approximately 12, 24, and 36 months following the initial procedure. It is anticipated that patients enrolled during the first study year will complete a maximum of three years of follow-up. However, if additional funds become available, the investigators plan to extend the follow-up of enrolled patients to five years.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of UF by imaging or pathology report within 2 years of enrollment initiation.
* Menstrual period within 12 months

Exclusion Criteria:

* Post-menopausal
* Men
* 55 years old or older
The Analgesic Efficacy of the Pectoral Block After Mastectomy

Unilateral mastectomy is associated with moderate to severe postoperative pain. A new regional anaesthetic technique has been recently described, call the PEC block. This technique consists of injecting local anaesthetic between different muscles of the chest in order to relieve postoperative pain. The investigators aim to verify that this technique has a clinical relevant postoperative analgesic effect. For that purpose, the investigators will randomise 50 patients scheduled to undergo unilateral mastectomy into two groups: one group will receive a PEC block after the induction of the general anaesthesia under ultrasound guidance, while the other group will not have this regional procedure.


Eligibility Criteria:
Inclusion Criteria:

* ASA physical status I-III
* Age ≥ 18
* Patients undergoing unilateral mastectomy

Exclusion Criteria:

* Contraindications to regional block
* Pregnancy
* Inability to give informed consent
* History of alcohol or drug dependence/abuse
* History of long term opioid intake or chronic pain disorder
Evaluating the Role of IGF-1 and S-Klotho In Plaque Phenotype and Vulnerability: the VISION Study.

Insulin-like growth factor 1 (IGF-1) is the primary peripheral mediator of growth hormone (GH) and has pleiotropic effects on development, differentiation, metabolism, and cell survival. Several in vivo and in vitro studies suggest that IGF-1 may have a protective effect on atherosclerosis as it suppresses macrophage recruitment and activation, cytokine production, and extracellular matrix degradation while promoting smooth muscle cell migration and proliferation and extracellular matrix deposition. The protein sKlotho appears to be closely related to the GH-IGF-1 axis, and some animal and in vitro studies hypothesize its protective role in the cardiovascular system. The GH-IGF-1 axis and sKlotho influence mechanisms determining coronary atherosclerosis. Circulating levels of IGF-1 and sKlotho may correlate with the morphology of atherosclerotic plaques and particularly with the vulnerability of coronary lesions.

Objectives: To evaluate the correlation between atherosclerotic plaque phenotype and the GH-IGF-1 axis and sKlotho in patients with chronic coronary syndrome using intravascular imaging with Optical Coherence Tomography (OCT).

Methods:All patients with chronic coronary syndrome who meet the inclusion and exclusion criteria and undergo coronary angiography and intravascular imaging with optical coherence tomography will be included. At the end of the procedure, a blood sample will be taken to measure IGF-1, sKlotho, and GH receptor (GHR) polymorphism.


Eligibility Criteria:
Inclusion Criteria:

* Patients with chronic coronary syndrome undergoing coronary angiographic study.
* Patients undergoing intravascular imaging with OCT during coronary angiographic study at the operator's discretion, for diagnostic purposes and/or to guide possible coronary artery disease treatment.
* Patients with at least 18 years of age.
* Patients able to provide informed consent.

Exclusion Criteria:

* Pregnancy.
* Pathological excess or deficiency of IGF-1.
* Stage IV chronic renal failure.
* Severe liver disease.
* Cachexia and/or malnutrition states.
* BMI \<18.5.
* HbA1C ≥ 8.5%.
* Left Ventricle Ejection Fraction (LVEF) \<= 35%
* Patients with aorto-coronary bypass.
* OCT analysis conducted on vessels with previous percutaneous coronary intervention with stent implantation.
Study of the Pharmacokinetics of Daptomycin in Children With Renal Disease

The purpose of this study is to:

1. Study the pharmacokinetics and safety of daptomycin in children on hemodialysis (HD) and peritoneal dialysis (PD).
2. Determine urine, HD and PD clearance of daptomycin.

Infectious and sepsis events are one of the most common complications in children with chronic kidney disease. The incidence is highest in children with an access for dialysis, especially in those with catheters. Staphylococcal species account for more than 50% of access infections (ranging from 58-77%). Failure to clear the infection results in loss of dialysis access.

Daptomycin is a new antibiotic that provides coverage against most gram positive bacteria including methicillin-resistant staphylococci, vancomycin-intermediate Staphylococcus aureus, and vancomycin-resistant enterococci. The pharmacokinetics of daptomycin in children on dialysis, a group of patients who may need the medication the most, remains unknown.

Children on HD or PD with suspected or confirmed infections due to gram-positive bacteria and who are concurrently treated with standard of care antibiotics will be considered for this study. Each patient will be given a onetime dose of Cubicin (daptomycin). After receiving daptomycin, serial blood samples along with dialysis effluent and urine (obtained from non-anuric patients) will be collected to evaluate the pharmacokinetic profile of the drug.

Eligibility Criteria:
Inclusion Criteria:

* Children who are between 12-17 years of age who are either on HD or PD and whom the Pediatric Nephrology Section of the OU Children's Physicians Clinics provide care.
* In addition to children on chronic HD and PD therapy, patients newly initiated on HD and PD will also be recruited for this study.
* Patients with suspected or confirmed cases of dialysis related infection from gram-positive bacteria and who are receiving standard of care antibiotics.
* Patients will be eligible for enrollment if they were admitted as an inpatient to the Children's hospital or as an outpatient to the dialysis clinic

Exclusion Criteria:

* Patients \> 17 years of age
* Patients \< 12 years of age
* Total amount of blood drawn as part of standard of care and for pharmacokinetic analysis exceeds 3 ml/kg over an 8 week period
* Taking an HMG CoA reductase inhibitor within 7 days of daptomycin administration
* Having used daptomycin in the 30 days preceding study entry
* Participating in any experimental procedure in the 30 days preceding study
* A history of muscular disease or neurological disease
* Baseline creatine phosphokinase (CPK) values equal to or greater than 1.5 times the upper limit of normal (normal range 65-370 IU/L)
* Hemoglobin \< 9 g/dl
* Hemodynamic instability within 72 hours before study enrollment
* Female subjects with a positive pregnancy test or failure to take a pregnancy test
Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention

To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.

A Phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to evaluate the efficacy and safety of AMG 301 in subjects with chronic migraine or episodic migraine.

Eligibility Criteria:
Inclusion Criteria:

* Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.
* History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013)
* Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening.
* Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy

Exclusion Criteria:

* Older than 50 years of age at migraine onset.
* History of cluster headache, hemiplegic migraine headache.
* Unable to differentiate migraine from other headaches.
* Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period.
* History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
Endothelium Dependent and Non-dependent Vasodilatation in Human Gingiva

The aim of this study is to compare the endothelim-dependent and non-dependent vasodilatation between genders in the human gingiva.

Gender differences were observed in studies according to gingival microcirculation between physiological circumstances and during wound healing as well.

For blood flow measurement Laser Spackle Contrast Imaging is a reliable tool. It has good reproducibility, it doesn't get in touch with the measured surface, it's easy to use and it can measure on a bigger surface in same time.

Two wells were fabricated on the labial surface of the right lateral incisor (test tooth) and on the labial surface of the left central incisor (control tooth). These wells are opened towards the high-prermeability gingival sulcus, so the dropped solutions nitroglycerine vs physiological saline or nitroglycerine vs physiological saline can esasily penetrate to the gingival tissues. After applying the solutions, the blood flow was monitored fot 15 minutes.

Eligibility Criteria:
Inclusion Criteria:

* general health
* minimum 5 mm keratinized gingiva at the upper front teeth
* good oral hygiene

Exclusion Criteria:

* pregnancy and breast-feeding
* smoking
* medication
* insufficient marginal integrity
* periodontitis
* caries
Luminopia One Amblyopia Vision Improvement Study

The objective of the study is to demonstrate the safety and efficacy of Luminopia One in amblyopia patients with amblyopia associated with anisometropia and/or with mild strabismus.

The proposed study is a multi-center randomized controlled clinical trial which compares the mean change in amblyopic eye Best Corrected Visual Acuity from baseline with Luminopia One ("therapeutic") to refractive correction ("control"). One-hundred and forty participants (n = 140) aged 4-7 years will be enrolled. Participants will be randomized 1:1 to the "therapeutic group ", to use Luminopia One, or the "control group", to undergo continued refractive correction, for 12 weeks of treatment.

Eligibility Criteria:
Inclusion Criteria:

* Age 4 to 7 years at the time of consent.
* Amblyopia associated with anisometropia and/or mild strabismus.
* Current refractive correction worn for at least 16 weeks or until 2 consecutive visual acuity measurements at least 8 weeks apart do not change by more than 1 logMAR lines.
* Amblyopic eye best-corrected visual acuity (BCVA) 20/40 to 20/200 inclusive.
* Fellow eye BCVA 20/32 or better.
* Interocular difference ≥ 3 logMAR lines.
* Heterotropia ≤ 5 prism diopters in current refractive correction at distance measured by SPCT.

Exclusion Criteria:

* Atropine treatment in the past 2 weeks.
* Prior amblyopia treatment (other than refractive correction) for \> 12 months in total.
* High myopia, previous intraocular / refractive surgery, severe ocular co-morbidities or development / cognitive delay.
* History of low adherence with amblyopia treatment or light-induced seizures.
Diaphragm Release Manual Technique Efficacy in COPD Patients

The aims of this study are to evaluate the effects of Diaphragm Release Manual Technique on diaphragm mobility, chest wall kinematics and functional capacity of COPD patients. Methods: Randomized controlled trial (double blinded) with COPD patients, allocated in two group: intervention (IG) who will receive the Diaphragm Release manual technique on 6 non-consecutive sessions and control group (CG), who will receive a sham protocol (light touch) with the same parameters of IG. Outcomes will be evaluated as: immediate and post treatment effects (after 1 and 6 sessions respectively). The primary outcome analysed will be the diaphragm displacement (ultrasonography evaluation) and secondary outcomes will comprise abdominal and chest wall kinematics.


Eligibility Criteria:
Inclusion Criteria:

* CPOD patients
* ex-smokers
* clinically stable patients (no exacerbation in the previous 6 weeks)
* forced expiratory volume in one second (FEV1) \< than 80% predicted
* FEV1/FVC ≤ 0.7, post bronchodilator

Exclusion Criteria:

* cardiopulmonary diseases
* BMI \> 30.0 kg/m2
* History of thoracic surgery
* Denial to participate
Safety and Efficacy Study of a Topical Minocycline Foam in Patients With Papulopustular Rosacea

The purpose of this study is to see if the study drug, FMX-103, is safe to give and if it helps people with moderate-to-severe papulopustular rosacea.

The investigational product is FMX-103 minocycline foam. Two concentrations of the investigational product, 1.5% and 3%, will be studied along with vehicle. The foam will be applied once daily to the face for the 12-week treatment duration of the study.

Approximately 210 patients will participate in this study.


Eligibility Criteria:
Inclusion Criteria:

1. Participants age is 18 years or older.
2. Participants have a moderate-to-severe rosacea excluding lesions involving the eyes and scalp.
3. Subject must have diagnosed rosacea for at least 6 months prior to screening.

Exclusion Criteria:

1. History of hypersensitivity or allergy to minocycline, any other tetracycline or any other component of the formulation such as Soybean oil or Coconut oil.
2. Women of child bearing potential who are pregnant, lactating (in the last 3 months) or planning to become pregnant during the study period.
3. Moderate or severe rhinophyma, dense telangiectasis (score 3, severe), or plaque- like facial edema.
4. Rosacea conglobata or fulminans, corticosteroid-induced rosacea or isolated pustulosis of the chin, facial erythrosis of known origin other than rosacea (e.g., known carcinoid syndrome).
5. Ocular rosacea (e.g., conjunctivitis, blepharitis, or keratitis) of sufficient severity to require topical ophthalmic or systemic antibiotics, papulopustular rosacea that requires medically indicated systemic treatment.
6. Bacterial folliculitis.
Safety and Efficacy of ALV003 for the Treatment of Celiac Disease

A phase 2a study to evaluate the safety and efficacy of ALV003 to treat celiac disease.

Double-blind, placebo controlled study of the efficacy, safety and tolerability of 6-weeks treatment of ALV003 in patients with well-controlled celiac disease. Approximately 110 biopsy proven celiac disease patients will be randomized to treatment with ALV003 or placebo in a 1:1 ratio. Patients will be required to have a pre-dose and a post-treatment intestinal biopsy, and also will be required to ingest a foodstuff that contains a specified amount of gluten during the active phase of the study along with the study treatment. Patients will return to the clinic weekly for the first two weeks, then every two weeks thereafter for safety visits. Patients will return to the clinic 28 days after completion of treatment for final safety and follow-up. Safety will be closely monitored throughout the study including laboratory parameters and clinical assessment of adverse events.

Eligibility Criteria:
Inclusion Criteria:

* History of biopsy-proven celiac disease
* Adherence to a gluten-free diet
* TG2 antibody negative
* Signed informed consent

Exclusion Criteria:

* Active dermatitis herpetiformis
* History of IgE-mediated reactions to gluten
* Use of specific medications 6 months prior to entry
* History of alcohol abuse or illicit drug use
* Current untreated or GI disease
* Positive pregnancy test
* Received any experimental drug within 14 days of randomization
* Uncontrolled chronic disease or condition
* Uncontrolled complications of celiac disease
* Any medical condition, which could adversely affect participation
Salud, Estrés y Resilencia en Familias/ Health, Stress, and Resilience Among Latino Families in the US

This study aims to prevent syndemic health conditions by decreasing acculturative stress and promoting resilience via SER Familia (Salud, Estrés y Resilencia en Familias/ Health, Stress, and Resilience in Families), a family-based intervention. SER Familia is a six-session intervention co-developed and delivered by community health workers (CHWs) that uses strategies to reduce acculturative stress, promote resilience, improve parent-child and family level health, while simultaneously helping families maintain strong social networks and better navigate community resources to address social determinants of health (SDOH). More specifically, investigators aim to: 1) Examine the efficacy of SER Familia to prevent or reduce the syndemic comprised of substance abuse, IPV, HIV risk, depression, and anxiety among Parents and Youth; and 2) Identify how individual, family, and community mechanisms of change related to acculturative stress and resilience mediates the effect of SER Familia.


Eligibility Criteria:
Inclusion Criteria:

* Eligible participants must identify as Hispanic/Latino/a/x/e,
* be a first generation immigrant parent or parental figure (Parent)
* have a child (Youth) aged 12-17
* speak English and/or Spanish

Exclusion Criteria:

* Families planning to move within two years will be excluded
EGFRdelEx19 and KRAS Exon 2 Mutation Detection in EBUS-TBNA

First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. In this study we want to compare a new highly sensitive method for the detection of EGFRdelEx19 and KRAS Exon 2 with targeted-resequencing multiplex-PCR (NGS).

First-line treatment with afatinib prolongs overall survival in patients with metastatic non-small-cell lung cancer (NSCLC) harboring EGFR exon 19 deletion mutations. Conversely, somatic KRAS mutations are negative predictors for benefit from EGFR-targeting agents. Rapid availability of these biomarker results is mandatory to prevent delayed or inferior treatments.

Endobronchial ultrasound-guided transbronchial needle aspiration (EBUS-TBNA) is well-established for lung cancer diagnosis and staging. Next generation sequencing (NGS) via targeted resequencing allows simultaneous interrogation for multiple mutations, but has its limitations based on the amount of tumor tissue required and assay times. RT-PCR using Light-Cycler technology (LC-RTPCR) is a rapid and sensitive assay to detect somatic mutations in various tissues from NSCLC patients. The study's aim was to analyze if LC-RTPCR is feasible for rapid EGFRdelEx19 and KRAS Exon 2 mutation detection in EBUS-TBNA samples and to compare results with results obtained via standard NGS mutation analyses.

Eligibility Criteria:
Inclusion Criteria:

* lung adenocarcinoma positive EBUS-TBNA specimen

Exclusion Criteria:

* other diagnosis