cyrilzakka/clinical-trials huggingface dataset:
Long-term Characterization of GORE® TAG® Conformable Thoracic Stent Graft With ACTIVE CONTROL System Performance

An observational, prospective multi-regional post-market registry collecting mid- and long-term data to assess outcomes through ten years of follow-up for subjects treated with GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System as a part of routine clinical practice. This post-market registry for the GORE® TAG® Conformable Thoracic Stent Graft with ACTIVE CONTROL System (CTAG w/AC) is intended to demonstrate that thoracic endovascular aortic repair (TEVAR) for lesions of the descending thoracic aorta continues to be a suitable treatment option for appropriately selected patients.


Eligibility Criteria:
Inclusion Criteria:

1. Patient or legally authorized representative (LAR) provides written authorization and/or consent per institution and geographical requirements.
2. Patient has been or is intended to be treated with an eligible registry device.\*
3. Patient is age ≥ 18 years at time of informed consent signature.

   * The intent to treat a patient with a Gore product must be made prior to soliciting for possible registry participation. If pre-procedure consent is not feasible, consent prior to the time of discharge for the index procedure is acceptable.

Exclusion Criteria:

1. Patient who is, at the time of consent, unlikely to be available for standard of care (SOC) follow-up visits as defined by the site's guidelines and procedures.
2. Patient with exclusion criteria required by local law.
3. Patient is currently enrolled in or plans to enroll in any concurrent investigational drug and/or investigational device study\* within 12 months of Together Registry enrollment. Subjects cannot be enrolled in another Together Registry module protocol.

   * The term "study" does not apply to other observational registries or quality improvement projects. Collection of Registry Device performance from interventional studies may be permissible provided device application is not investigational and there are no novel requirements that alter follow-up conduct (i.e., protocol-mandated interventions).
Diabetic Retinopathy And the Myvisiontrack® (DRAMA) Study

The purpose of this study is to determine the effect of enhancements to the myVisionTrack® in regards to patient compliance and test-retest variability. Additionally, the ability of myVisionTrack® to detect changes in vision function will be evaluated.

The results of this study will provide the basis for patient self-monitoring of visual function with the myVisionTrack®, and for reporting, storage, and maintenance of collected data. The myVisionTrack® is intended to be used remotely by patients to monitor their disease. In the case of significant changes, patients will be prompted to visit their ophthalmologist. It is hypothesized that this can lead to earlier detection of disease progression, which, in turn, can lead to earlier treatment and better prevention against vision loss due to diabetic retinopathy (DR).

Eligibility Criteria:
Inclusion Criteria:

* DR or AMD requiring treatment at time of study initiation
* Macular edema involving the central subfield based on clinical judgment
* No noticeable central subfield atrophy
* Patients willing and able to comply with all study and follow-up procedures (including the handling of the myVisionTrack™ device)

Exclusion Criteria:

* Any ocular pathology other than DR or AMD
* Any other concurrent systemic illness affecting the retina and visual function
* Dementia or other neurological or psychological limitation that would prevent patients from performing self-testing of visual function
* Past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve
* Use of investigational drugs at the time of screening, or within 60 days (excluding vitamins and minerals)
* Pregnancy
Novel Approach of Hayman Uterine Compression Sutures for Management of Severe Atonic Postpartum Hemorrhage: Three Vertical Sutures

Maternal deaths due to uterine atony bleeding are the leading causes of maternal death in our country and all over the world. In this respect, our clinic is among the clinics with the highest number of experience in our country and aims to reduce maternal deaths and mothers who will need intensive care due to bleeding with a hemorrhage stopping technique that will have a serious contribution to both our country and the world literature.

Our primary goal, thanks to the bleeding-stopping technique, to reduce their deaths. Our secondary aim is, thanks to the bleeding-stopping technique we offer, To prevent and reduce the complications seen in mothers during the operative period.

Our research was carried out to our obstetrics clinic between 01 Agustus 2015 - 01 December 2020.

Patients transplanted due to postpartum bleeding and patients requiring surgery due to abnormal postpartum bleeding in our clinic will be included. Patients with a previously known bleeding disorder will not be included in the study. In our study, the parameters of the patients who had bleeding due to postpartum uterine atony and who needed uterine surgery previously underwent triple Hayman compression suture to stop bleeding will be included in the study. Patients with a triple Hayman suture covering the upper 2/3 of the uterus to stop uterine bleeding will be evaluated in the study.

Eligibility Criteria:
Inclusion Criteria:

* Postpartum bleeding after birth
* Patients referred to our clinic from an external center due to postpartum bleeding
* Patients who have given birth due to pregnancy older than 24 weeks and have atony bleeding

Exclusion Criteria:

-
Effect of Paratracheal Esophagus Pressure on the Insertion of Laryngeal Mask Airway

Laryngeal mask airway is inserted into the oral cavity and seals the upper esophagus and the surrounding tissue, effectively securing airway. Laryngeal mask airway has been widely adopted in the clinical practice.

On the other hand, cricoid pressure has been used to reduce the risk of pulmonary aspiration of gastric contents during induction of general anesthesia. However, cricoid pressure might impede placement of the laryngeal mask airway, thereby preventing effective ventilation.

Recently, left paratracheal pressure was introduced as an alternative to cricoid pressure and reported to be more effective than cricoid pressure in the prevention of gastric air insufflation during positive-pressure ventilation by facemask. Since this method compresses low left paratracheal level, it may affect the successful insertion of laryngeal mask airway.

In this study, the investigators aimed to evaluate the effect of paratracheal esophagus pressure on the insertion of laryngeal mask airway compare to conventional cricoid pressure.


Eligibility Criteria:
Inclusion Criteria:

* Patients who are undergoing surgery under general anesthesia where supraglottic airway management will be appropriate
* American Society of Anesthesiologists Classification 1-2

Exclusion Criteria:

* Body mass index \> 35 kg/m2
* High risk of regurgitation (hiatus hernia, gastro-esophageal reflux disease, non-fasting status)
* Criteria for difficult airway (limitation of mouth opening/neck extension, Mallampati class IV),
Multi-Reader Multi-Case Study to Identify Uterine Contractions Recorded From Laboring Patients by Practicing Clinicians

This multi-reader multi-case study was designed to evaluate the performance of SureCALL® EMG Labor Monitor® (SureCALL®)to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".

The SureCALL® EMG Labor Monitor® (SureCALL®)is a transabdominal electromyography monitor intended to measure intrapartum uterine activity. It is intended for use on term pregnant women who are in labor, with singleton pregnancies, using surface electrodes on the maternal abdomen. The device is intended for use by healthcare professionals in a clinical setting.

This multi-reader multi-case study was designed to evaluate the performance of SureCALL® to the predicate Tocodynamometer device (TOCO) using the performance of an Intrauterine Pressure Catheter device (IUPC) as the "gold standard".

This study involved 20 women at term, in labor, at three clinical sites. Each study subject was instrumented with three technologies for measuring uterine activity:

1. a tocodynamometer attached to the maternal abdomen
2. a set of abdominal surface electrodes for uterine electromyography, and
3. an intrauterine pressure catheter.

An assessment was obtained and quantified from masked, qualified clinical obstetrician readers for the evaluation of the equivalence of the three independent labor monitor devices by identifying in isolation the individual uterine contraction signals and the peak of each contraction signal produced by a full-term patient in term labor as independently collected by each labor monitor device.

Eligibility Criteria:
Inclusion Criteria:

* Singleton Pregnancy
* Indicated for IUPC
* Gestational ages from 37 to 41 weeks
* Informed consent required

Exclusion Criteria:

* Multifetal pregnancy
* Not Indicated for IUPC
* Gestation age below 37 or above 41 weeks
* Informed consent not given
Sulcular Bristle Tip Technique (SBTT) With an Electric Toothbrush

In this study, all subjects will be given an electric toothbrush. Half of the participants will be instructed on how to use the Sulcular Bristle Tip Technique (SBTT). The other half of participants will be asked to follow the brushing instructions in the user manual. The study's primary aim is to compare the use of the SBTT with an electric toothbrush in reducing bleeding on probing with the use of an electric toothbrush used without personal professional instruction.


Eligibility Criteria:
Inclusion Criteria:

* At least 18 years of age
* Subjects must show \> 20% buccal/lingual cervical sites with bleeding on probing (BoP)
* Subjects must have \> 24 natural teeth excluding third molars
* Subjects must have had a professional dental prophylaxis within three months of beginning the study
* Subjects must be willing to brush with electric toothbrush twice daily.
* Subjects who are randomized into Group 1 must be willing to be taught and to demonstrate the SBTT
* Subjects who are randomized into Group 2 must be willing to follow the Sonicare DFU from Philips Oral Healthcare; however, will otherwise be uninstructed until after the study has been completed
* Subjects must be willing to refrain from any oral hygiene for at least 12-18 hours prior to each study follow-up visit.

Exclusion Criteria:

* Subjects who use tobacco products
* Subjects who are currently pregnant (self-reported) due to the greater bleeding tendency caused by hormonal changes
* Subjects with fixed or removable orthodontic appliances
* Subjects whose restorations violate or potentially violate the biologic width.
* Subjects with irregular restoration margins or overhanging margins within 1mm of the crest of the marginal gingiva.
* Antibiotic treatment at the time of the initial examination or during the month prior
* Subjects with cervical probing depth \>3 mm
* Subjects with systemic diseases that affect the gingiva
* Subjects taking medications that affect the gingiva
* Subjects who cannot read/write/speak English
Human Algorithm Interactions for Acute Respiratory Failure Diagnosis

Artificial intelligence (AI) shows promising in identifying abnormalities in clinical images. However, systematically biased AI models, where a model makes inaccurate predictions for entire subpopulations, can lead to errors and potential harms. When shown incorrect predictions from an AI model, clinician diagnostic accuracy can be harmed. This study aims to study the effectiveness of providing clinicians with image-based AI model explanations when provided AI model predictions to help clinicians better understand the logic of an AI model's prediction. It will evaluate whether providing clinicians with AI model explanations can improve diagnostic accuracy and help clinicians catch when models are making incorrect decisions. As a test case, the study will focus on the diagnosis of acute respiratory failure because determining the underlying causes of acute respiratory failure is critically important for guiding treatment decisions but can be clinically challenging.

To determine if providing AI explanations can improve clinician diagnostic accuracy and alleviate the potential impact of showing clinicians a systematically biased AI model, a randomized clinical vignette survey study will be conducted. During the survey, study participants will be shown clinical vignettes of patients hospitalized with acute respiratory failure, including the patient's presenting symptoms, physical exam, laboratory results, and chest X-ray. Study participants will then be asked to assess the likelihood that heart failure, pneumonia and/or Chronic Obstructive Pulmonary Disease (COPD) is the underlying diagnosis. During specific vignettes in the survey, participants will also be shown standard or systematically biased AI models that provide an estimate the likelihood that heart failure, pneumonia and/or COPD is the underlying diagnosis. Clinicians will be randomized see AI predictions alone or AI predictions with explanations when shown AI models. This survey design will allow for testing the hypothesis that systematically biased models would harm clinician diagnostic accuracy, but commonly used image-based explanations would help clinicians partially recover their performance.


Eligibility Criteria:
Inclusion Criteria:

* Physicians, nurse practitioners, and physician assistants that care for patients with acute respiratory failure as part of their clinical practice

Exclusion Criteria:

* Physicians, nurse practitioners, and physician assistants that only provide patient care in outpatient settings
Trial on The Efficacy of Hypertonic Saline on Non-CF CSLD.

To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.

Secondary Aims:

To determine the:

1. Efficacy of nebulized 5% hypertonic saline on airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics.
2. Efficacy of nebulized 5% hypertonic saline on lung function
3. Adverse effects of nebulized 5% hypertonic saline in children

Primary Aim:

To determine the efficacy of nebulized 5% hypertonic saline on cough severity and quality of life, in children with non-CF CSLD.

Here the investigators will be using validated pediatric cough questionnaires to asses this. Patients will answer these questionnaires at first recruitment ( -1 mth), at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths)

Secondary Aims:

To determine the:

1. Efficacy of nebulized 5% hypertonic saline on the airway microbiome, pulmonary exacerbation rate, healthcare utilization, and rescue antibiotics.

   Here the investigators will be taking history on the exacerbations, use of antibiotics and healthcare utilization before and after use of the hypertonic saline. Furthermore, Nasopharyngeal swabs will be done to review possible changes in microbiota, again before and after use of the 5% HS.
2. Efficacy of nebulized 5% hypertonic saline on lung function. Here is investigators will be doing portable spirometry ( pre and post bronchodilator).

   Patients will perform at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths)
3. Adverse effects of nebulized 5% hypertonic saline in children HS has been associated with side-effects. The investigators will monitor this. We will asses presence of these symptoms at randomization (0 month) and after 3 mths of use of the nebulized study drug (+ 3 mths) to ensure these are from the nebulizer.

Eligibility Criteria:
Inclusion Criteria:

* Patients \< 18 years old
* Followed up in the paediatric respiratory clinic of UMMC with a diagnosis of CSLD

Exclusion Criteria:

* Incomplete data or refusal to participate
* Unwell and/or unable to stop HS and/or antibiotics of any preparation other than azithromycin ( EOD
* On supplementary oxygen/home ventilation
* Poorly controlled asthma (as in the GINA guidelines) or bronchoconstriction that precedes the use of hypertonic saline.
* Oral antibiotics for less than 4 weeks before randomization for medication.
* Fall in PEFR \> 20% post 5% HS challenge test or a positive HS challenge test in young children, as mentioned below.
A Pilot Study of Individualized Adaptive Radiation Therapy for Hepatocellular Carcinoma

This is a pilot single arm study with the primary endpoints of feasibility and preliminary estimates of safety and efficacy. This protocol builds on over 25 years of experience with high dose liver RT (Radiation Therapy), and in particular adaptive RT aimed at adjusting the global radiation dose based on a patient's measured sensitivity to treatment. This current protocol uses functional imaging and specialized radiation planning techniques to spare highly functional portions of the liver to preserve function. The investigators feel this will further improve the safety and efficacy of RT for all patients by customizing treatments to each. If this approach is promising, the investigators will proceed to a phase II randomized study of standard versus spatially and dosimetrically adapted RT.


Eligibility Criteria:
Inclusion Criteria:

* Patients must have hepatocellular carcinoma.
* Patients must not have extrahepatic cancer.
* Patients must not be eligible for a curative liver resection or have refused resection
* Patients must have recovered from the acute effects of prior liver-directed therapy and 4 weeks must have passed since the last procedure and protocol therapy.
* Patients must have a Zubrod performance status of less than or equal to 2 (Zubrod performance status is a measure that attempts to quantify a cancer patients' general well-being. Scores run from 0 to 5 where 0 denotes normal activity and 5 denotes death).
* Patients must be 18 years of age or older.
* Patients must have adequate organ function.
* Patients must understand and be willing to sign an IRB (Institutional Review Board) approved informed consent form.

Exclusion Criteria:

* Patients with known allergies to intravenous iodinated contrast agents.
* Patients with a contraindication to contrast-enhanced MRI are excluded.
The Involvement of ATP Sensitive Potassium Channel in Migraine Aura and Migraine Pain.

The aim of the present study to investigate whether

* Opening of KATP channels causes migraine pain by activation of meningeal nociceptors and ascending trigeminal nociceptive pathways.
* Opening of KATP channels causes migraine aura by induction of CSD.

Migraine Pain The trigeminovascular system is the anatomical and physiological substrate of migraine pain. Nociceptive transmission originates from activation and sensitization of first-order trigeminovascular neurons. Their cell bodies are in the trigeminal ganglion, and their afferent fibers innervate the meninges and its vessels. Ascending nociceptive transmission from the trigeminal ganglion is projected to the brain stem, activating and sensitizing second-order trigeminovascular neurons, including those in the spinal trigeminal nucleus. This, in turn, activates and sensitizes third-order trigeminovascular neurons in the thalamus, which subsequently relay the nociceptive transmission to the somatosensory cortex and other cortical areas, ultimately resulting in migraine pain.

Although the biological underpinnings of migraine pain are incompletely understood, signaling pathways have been identified that are putatively responsible for the genesis of migraine pain. Recent human experimental data have implicated opening of KATP channels in migraine pathogenesis. In two randomized controlled trials, it was demonstrated that intravenous infusion of levcromakalim - an opener of KATP channels - induced migraine pain in people with migraine with and without aura.

- It remains unknown whether KATP channel opening causes migraine pain by activation of meningeal nociceptors and ascending trigeminal nociceptive pathways, as proposed during spontaneous migraine attacks.

Migraine Aura About one-third of people with migraine experience aura symptoms, which are characterized by reversible focal neurologic symptoms, typically comprising visual or hemisensory disturbances. The physiological substrate of the aura phase of migraine is thought to be cortical spreading depression (CSD), a self-propagating wave of depolarization across the cerebral cortex that disrupts ionic gradients and is followed by cerebral hypoperfusion. Recently, it was reported that intravenous infusion of levcromakalim - an opener of KATP channels - induced migraine aura in migraine with aura patients.

- It remains unknown whether KATP channel opening causes CSD which leads to migraine aura, as observed during spontaneous migraine attacks.

Eligibility Criteria:
Inclusion Criteria:

* Migraine patients
* 18-60 years.
* 50-100 kg.
* Women of childbearing potential must use adequate contraception.

Exclusion Criteria:

* A history of serious somatic disease
* Any other type of headache (except episodic tension-type headache less than once a month) Daily intake of any medication except contraceptives Contraindications for MRI scan.