cyrilzakka/clinical-trials huggingface dataset:
Stenting and Angioplasty With Protection in Patients at High Risk for Endarterectomy (SAPPHIRE)

The primary objective of this study is to compare the safety and effectiveness of the Cordis Nitinol Carotid Stent and Delivery Systems (5.5 F and 7 F) with the ANGIOGUARD XP distal protective device to CEA in the treatment of carotid artery disease in patients at increased risk for surgery.


Eligibility Criteria:
Inclusion Criteria:

1. The patient must be \> 18 years of age.
2. The patient has a 50% stenosis (as determined by ultrasound or angiogram) of the common or internal carotid artery and is clinically symptomatic; i.e., within the previous 180 days has experienced symptoms in the ipsilateral carotid artery distribution, defined as:

   * one or more TIAs, characterized by distinct focal neurologic dysfunction or monocular blindness with clearing of signs and symptoms within 24 hours, or
   * one or more completed strokes (as defined by this protocol) with persistence of symptoms or signs for more than 24 hours (the most recent event is used as the qualifying event), except as excluded below, with stenosis \>50%, (as determined by ultrasound or angiogram) of the common or internal carotid artery, OR The patient must have a \>80% diameter stenosis (as determined by ultrasound or angiogram) of the internal or common carotid artery without neurological symptoms.
3. To be entered into the study, the patient must have one or more of the following conditions:

   * congestive heart failure (class III/IV) and/or known severe left ventricular dysfunction LVEF \< 30%
   * open heart surgery within six weeks
   * recent MI (\>24 hours and \<4 weeks)
   * unstable angina (CCS class III/IV)
   * synchronous severe cardiac and carotid disease requiring open heart surgery and carotid revascularization
   * Age greater than 80 years as a single risk factor.

Exclusion Criteria:

1. The patient is experiencing an acute ischemic neurologic stroke or has experienced a stroke within the past 48 hours.
2. The patient has an intracranial mass lesion (i.e., abscess, tumor, or infection).
3. The reference segment diameter (distal common carotid and internal carotid artery segment cephalic to the lesion) is less than 4mm or greater than 9mm by quantitative analysis. See Instructions For Use, for proper stent sizing. The exception to this would be with a lesion having \>95% stenosis where the true diameter of the distal vessel can not be determined such as the case with a string sign or distal vessel collapse. In this case the judgment of the interventionalist will prevail with the intention not to oversize the stent to the distal vessel by more than 2mm.
4. The patient has known peripheral vascular, supra-aortic or internal carotid artery tortuosity which preclude the use of catheter-based techniques if so randomized.
5. The patient has any intracranial aneurysm (\> 9 mm).
Supreme-LMA for Neonatal Resuscitation: a Prospective, Randomized Single-center Study

Laryngeal mask airways (LMA) that fit over the laryngeal inlet have been shown to be effective for ventilating newborns at birth. The LMA may be considered as an alternative to FM for positive pressure ventilation (PPV) among newborns weighing \>2000 g or delivered \>34 weeks' gestation.

A recent, quasi-experimental study provided the feasibility, efficacy and safety of using the LMA in neonatal resuscitation.

However, studies of LMA use for providing PPV during neonatal resuscitation are still limited. There are no published clinical randomized trials evaluating the LMA compared with the FM for neonatal resuscitation.

Hypothesis: Our hypothesis is based on the assumption that ventilating newborns needing PPV with a LMA will be more effective than ventilating with a FM by decreasing the proportion of resuscitated newborns needing ETT.

Objective: To compare the effectiveness of LMA and FM ventilation in newborns needing PPV at birth.

Design / Methods: An open, prospective, randomized, single center, clinical trial.

Intervention: PPV will be performed with a LMA (intervention group) or with a FM (control group) in all infant newborns weighing \>2000 g or delivered \>34 weeks gestation.

Primary outcome variable: Proportion of newborns needing endotracheal intubation.

Secondary outcome measures: Apgar score at 5 minutes, heart rate at 60, 90 seconds and 5 and 10 minutes, time to first breath, duration of PPV, for proportion of infants needing chest compressions, drugs and death within 1 week and/or presence of HIE, grade II or III, according to a modification of Sarnat and Sarnat.2,10 According to this classification, HIE grade I (mild) includes irritability, hyperalertness, mild hypotonia, and poor sucking; grade II (moderate) includes lethargy, seizures, marked abnormalities of tone, and requirement of tube feeding; and grade III (severe) includes coma, prolonged seizures, severe hypotonia, and failure to maintain spontaneous respiration.

The following data were collected during resuscitation: (1) Apgar score at 1 min and 5 min after birth; (2) LMA insertion time, the rate of successful insertion at the first attempt, and the number of attempts required to insert the LMA successfully; (3) duration of resuscitation: response time (the time period from starting LMA resuscitation to achieving an effective response), ventilation time; (4) adverse effects during resuscitation.


Eligibility Criteria:
Inclusion Criteria:

* Infants with gestational age ≥34 weeks, an expected birth weight \>1.500 g, needing positive pressure ventilation at birth.

Exclusion Criteria:

* Lethal anomalies, hydrops, major malformations of the respiratory system, congenital heart disease, and stillbirths
Frequency of Endometrial Cancer Precursors Associated with Lynch Syndrome

Given that there is a significant prevalence of Lynch syndrome among patients with endometrial cancer (about 5% of patients with endometrial cancer), and given there is a known risk of endometrial cancer among patients with endometrial hyperplasia (40% risk of pre-existing occult cancer with endometrial intraepithelial neoplasia), it is hypothesized that a diagnosis of endometrial hyperplasia may herald on-going risk of harboring a Lynch Syndrome gene mutation.

The purpose of this study is to examine endometrial hyperplasia specimens and compare the frequency of Lynch Syndrome gene mutations between endometrial hyperplasia and endometrial cancer subjects. This will provide a rationale and opportunity for earlier screening, and reduce colon cancer morbidity and mortality secondary to the Lynch syndrome gene.

This is an observational cohort study. Tissue specimens obtained that have been labeled with the diagnosis of endometrial hyperplasia will be identified and their chart reviewed for demographic date of age, race, body mass index, and co-morbidities. The specimen will then be tested via immunohistochemistry for the mismatch repair proteins MLH1, PMS2, MSH2, or MSH 6. Their absence is indicative of Lynch Syndrome. Statistical analysis will then be performed to compare the incidence of Lynch syndrome in endometrial hyperplasia with Lynch Syndrome in endometrial cancer.

Eligibility Criteria:
Inclusion Criteria:

* Appropriate specimen, hysterectomy or biopsy with final labeled diagnosis of endometrial hyperplasia of any grade

Exclusion Criteria:

* Any specimen that is later associated with endometrial cancer in subsequent pathology exam
DEvice-Detected CArdiac Tachyarrhythmic Events and Sleep-disordered Breathing (DEDiCATES)

This prospective multicenter registry study aims to determine whether device-detected sleep-disordered breathing events are associated increased risk of cardiac arrhythmias or other cardiovascular outcomes.

The prevalence of SDB high in patients with cardiac implantable electronic device (CIED). Recently, device-detected SDB events showed a correlation with sleep-disordered breathing (SDB) diagnosed by polysomnography. Thus, CIED will facilitate early detection and monitoring of SDB in patients with CIEDs. Few studies investigated prognostic value of CIED-detected SDB in risk of cardiovascular events. Therefore, the primary aim is to determine whether device-detected SDB are associated with increased risk of cardiac arrhythmias or other cardiovascular morbidities using a prospective multicenter registry.

Eligibility Criteria:
Inclusion Criteria:

* age ≥ 19years
* CHA2DS2VASc score ≥ 1 in male or ≥ 2 in female

Exclusion Criteria:

* CIED without atrial lead
* persistent or permanent atrial fibrillation (AF) or flutter
* history of catheter of surgical ablation of AF
* valvular steno-insufficiency more than moderate degree
* chronic obstructive pulmonary disease
* under current treatment for sleep-disordered breathing
* life expectancy \< 1year
The Adapting Disease Specific Outcome Measures Pilot Trial for Telehealth in Myasthenia Gravis

The goal of this pilot study is to determine the reliability of myasthenia gravis (MG) specific outcome measures obtained during virtual encounters with patients with myasthenia gravis. The main question it aims to answer is: Are MG-specific outcome measures obtained during virtual encounters reliable?

Participants will complete two virtual study visits in which they will be administered common MG-specific outcome measures and a newly developed outcome measure developed specifically for telemedicine assessments of MG patients.

The purpose of this study is to better understand the use of modified clinical assessments during telehealth visits for patients with Myasthenia Gravis (MG). The study will consist of 2 virtual telemedicine visits. A screening visit will be conducted to optimize the telemedicine environment, provide training on the telemedicine platform being used in the study, and collect demographic, medical history, and medication information. Participants who meet eligibility requirements will have a telemedicine visit (Visit 1) with a study doctor where assessments adapted for the telemedicine environment will be performed. Participants will also be asked to fill out questionnaires related to MG or their experience with telemedicine either online or with the study investigators. A second visit (Visit 2), conducted within 3 days (+/- 1 day), will replicate the assessments performed in V1. Visit 1 and Visit 2 will be recorded for later review by study team members. The investigators hope to establish the effectiveness of these clinical tools in order to better manage MG in the future in clinical care and research study visits.

Eligibility Criteria:
Inclusion Criteria:

* Has the capacity to understand and sign an informed consent form
* Diagnosed with acquired autoimmune MG based on clinical syndrome and seropositivity for MG associated autoantibodies (AChR binding, MuSK, or LRP4 antibodies), and/or a decremental response on repetitive nerve stimulation, positive single-fiber electromyography or positive edrophonium test
* Subject has been previously evaluated in a face-to-face clinical encounter at one of the participating study sites within the prior 3 years
* Primary language is English, or equivalent level of English language fluency
* Required disease severity range from asymptomatic-mild to moderate-severe as previously judged by the Investigator.

Exclusion Criteria:

* Inadequate technology for telehealth visits as assessed by the Investigator (e.g., no internet connection, no laptop/tablet with video capability, etc). Cellular phones are not acceptable. Subjects must use a laptop or tablet.
* Is unable or unwilling to comply with the study procedures, including video recording, or telehealth visit.
* Any significant medical/psychiatric condition that, in the opinion of the Investigator, may interfere with interpretation of subject evaluation(s) or protocol compliance
* Known pregnancy
* MGFA severity class IVb or V
* Concurrent participation in an interventional clinical trial
Usefulness and Efficacy of Telemonitoring of Patients With COPD

A substantial number of people with COPD suffer from exacerbations, which are defined as an acute worsening of respiratory symptoms. To minimize exacerbations, telehealth has emerged as an alternative to improve clinical management, access to health care, and support for self-management. The study objective was to map the evidence of telehealth/telemedicine for the monitoring of adult COPD patients after hospitalization due to an exacerbation.

Chronic obstructive pulmonary disease (COPD) is a major public health problem due to its high prevalence along with high morbi-mortality. Indeed, it is the third leading cause of all-cause death worldwide. COPD is marked by the onset of acute exacerbations (AECOP), which accelerate the progression of the disease, the decline in respiratory function resulting in poor quality of life with a worse survival. Therapeutic education of patients concerning treatment compliance and avoidance of exacerbating factors is one of the means of preventing AECOPD. Education sessions usually occur during during consultations and hospitalizations. Face-to-face visits with health professionals can be hindered by severity of COPD, geographic distance and limited access to health care services.

Telemonitoring patients with COPD could improve delivery of health care, reduce exacerbations, improve quality of life, and results in lower rates of hospitalisation. However, it is unclear whether providing telehealth care improves outcomes of patients with COPD.

This trial aimed to assess the usefulness and efficay of telemonitoring patients with AECOP

Eligibility Criteria:
Inclusion Criteria:

* Patients aged over 18 years old with prior diagnosis of COPD according to GOLD criteria

Exclusion Criteria:

* dementia
* pregnancy
* reluctance or self-declared inability to engage in the study
* simultaneous participation in another trial involving a therapeutic or non-therapeutic intervention that will interfere with the primary and secondary endpoints of this study.
Pediatric Type III Supracondylar Humeral Fracture

The purpose of this study was to compare pin configuration effects on early secondary displacement in the surgical treatment of pediatric supracondylar humeral fractures (SCHF).

The study consisted of 100 (68M, 32F) children who underwent surgery between 2010 and 2013 for Gartland Type 3 (SCHF). The patients divided into five groups according to the top in configurations (crossed 1 lateral 1 medial, crossed 2 lateral 1 medial, crossed 1 lateral 2 medial, 2 lateral divergent, and 3 lateral divergent). The average age at the time of injury was 7.34 (between 2 and 14 years). Bauman angle (BA), Humerocapital angle (HCA), Anterior humeral line (AHL), flexion range, extension range, and Carrying angle (CA) were compared at preoperative, postoperative 1st-day, postoperative last control, and non-operated side. The mean follow-up time 24,96±11,06 with a range of 12-54 months.

Eligibility Criteria:
Inclusion Criteria

* Pediatric Gartland Type 3 supracondylar humeral fracture
* Patients operated between 2010-2013
* Patients under 16 years old

Exclusion Criteria:

* Pathological fractures
* Conservative treated supracondylar fractures
* Less than the 1-year follow-up
* Patients with incomplete postoperative follow-up
* Patients older than 16 years
* Pediatric Gartland Type 1 and 2 supracondylar humeral fracture
A Study of LY3025876 in Participants With Diabetes

The main purpose of this study is to assess the safety and tolerability of LY3025876 given alone (Part A) and in combination with liraglutide (Part B) in participants with type 2 diabetes mellitus (T2DM).

This study will also evaluate how much of the study drug enters the blood stream and how long it takes for the body to remove the study drug. Information about any side effects that may occur will also be collected. Participants will continue their usual diet and exercise program and may remain on their physician-prescribed dose of metformin.

Each part of the study is expected to last 10 to 12 weeks on average, not including screening. Participants may only enroll in one part.

Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of type 2 diabetes mellitus (T2DM) as determined by the investigator, controlled with diet or exercise alone or on a stable dose of metformin for at least 30 days
* Have a body mass index (BMI) greater than or equal to 23 and less than or equal to 45 kilograms per square meter (kg/m\^2) at screening
* Have a supine blood pressure reading at screening of between 90-160 millimeter of mercury (mmHg) (systolic) and 40-95 mmHg (diastolic)
* Women not of child-bearing potential due to surgical sterilization (hysterectomy or bilateral oophorectomy or tubal ligation) or menopause

Exclusion Criteria:

* Have taken LY3025876 or investigational drugs like it (for example, other fibroblast growth factor-21 \[FGF21\]-related drugs) or have known allergies to these drugs
* History or presence of bone disease (including osteoporosis or unhealed fractures)
* Current active treatment of periodontal disease
* Have had a significant change in weight, defined as a gain or loss of at least 4 kilogram (kg) (9 pounds) in the last 3 months
* Have had greater than 1 episode of severe hypoglycemia within 6 months of screening that required the assistance of another person to actively administer carbohydrate, glucagon, or other resuscitative actions or had a seizure or coma
* Have known allergies or a history of intolerance to liraglutide, glucagon-like peptide 1 (GLP-1) analogues, or other related compounds
* Have a history of acute or chronic pancreatitis
* Have a personal or family history of medullary thyroid carcinoma or have multiple endocrine neoplasia syndrome type 2
Vaginal Dinoprostone Administration Prior to a T380A Intrauterine Device Insertion in Nulliparous Women.

To investigate whether vaginal dinoprostone administered before intrauterine device (IUD) insertion reduces failed insertions, insertion-related complications and pain in nulliparous women.

Women may experience pain and technical difﬁculties may be encountered when insertion of an intrauterine device (IUD) is attempted through a narrow cervical canal.IUD insertion- related complications and side effects are more common among women who had never delivered vaginally.n American College of Obstetricians and Gynecologists committee opinion encourages providers to use IUDs as a ﬁrst line of contraception in nulliparous women.

Eligibility Criteria:
Inclusion Criteria:

* Nulliparous women aged over 18 years of age requesting a copper IUD for contraception, had a negative pregnancy test.

Exclusion Criteria:

* • a prior pregnancy greater than 20 weeks of duration

  * currently pregnant or were pregnant within 6 weeks of study entry
  * had a prior attempted or successful IUD insertion
  * had a history of a cervical procedure such as cone biopsy, Loop electrosurgical excision procedure, or cryotherapy
  * any World Health Organization Medical Eligibility Criteria category 3 or 4 precaution to an IUD
  * active vaginitis or cervicitis
  * undiagnosed abnormal uterine bleeding
  * pelvic inﬂammatory disease within the last 3 months
  * ﬁbroids or other uterine abnormalities distorting the uterine cavity
  * contraindication to dinoprostone.
Effect of Exogenous Lactate on Neurocognitive in Brain Trauma

Mild traumatic brain injury (TBI) is the most common type of brain injury. Post-mild TBI disability could stem from cognitive, physical, psychological and social dysfunction which resulted in significant disability and unemployment. Long-term behavioral impairments which affected the individual's occupation, lifestyle, and family frequently occurred in individuals with mild to moderate brain injuries who physically fully recovered. In-vitro and in-vivo studies showed a better recovery of cognitive function after administration of exogenous lactate in traumatic brain injury. Therefore, this study is aimed to evaluate the effect of exogenous lactate infusion contained in hyperosmolar sodium lactate solution on cognitive function assessed by Mini Mental State Examination(MMSE)scale.

Mild traumatic brain injury (TBI) is the most common type of brain injury. Post-mild TBI disability could stem from cognitive, physical, psychological and social dysfunction which resulted in significant disability and unemployment. Cognitive impairment post traumatic brain injury is due to the disruption of brain vascular bed and microstructural damage. Currently, there is no specific therapy for individual with mild TBI. Neuropsychological assessment and early management immediately after mild traumatic brain injury have been shown to reduce long term cognitive disability. In-vitro and in-vivo studies showed a better recovery of cognitive function after administration of exogenous lactate in traumatic brain injury.

The role of lactate in cerebral energy metabolism has been investigated widely. The ability of lactate as the sole energy substrate to support synaptic function has been demonstrated by different studies. In many studies, lactate has been proven to be a preferred or even an obligatory substrate over glucose for aerobic energy production during the initial stage of recovery from cerebral ischemia or hypoxia for recovery from ATP-depleted synaptic function and exogenously supplied lactate can support the early recovery of synaptic function after hypoxia.

However, the clinical studies evaluated the effect of lactate administration on cognitive function in patients with mild traumatic brain injury are still limited. Therefore, we conduct a study to evaluate the effect of exogenous lactate infusion contained in hyperosmolar sodium lactate solution on cognitive function assessed by Mini Mental State Examination (MMSE) score evolution in mild traumatic brain injury compared with patients receiving hyperosmolar sodium chloride 3 % as a control group. MMSE score can be used as a tool to describe cognitive function.

Eligibility Criteria:
Inclusion Criteria:

* Mild traumatic brain injury
* Glasgow Coma Scale (GCS) of 14-15
* Requires emergency neurosurgery procedures
* Physical status ASA I-II
* Onset of trauma \< 9 hours

Exclusion Criteria:

* Multiple injury
* Pregnancy/lactation
* History of alcohol or barbiturate consumption prior to the injury
The Role of a Mediterranean Diet in Patients With Endometriosis: a Feasibility Trial

This study aims to test if making changes to diet can affect the pelvic pain associated with endometriosis. One group will follow a Mediterranean diet for 12 weeks while the control group will continue with their current diet. We will be looking at the feasibility of a larger-scale trial as well as self-reported quality of life and self-reported pain using standardized questionnaires, that have previously been used and validated, and assessing how this diet affects biomarkers associated with endometriosis and inflammation. Further, we will test how this change in diet affects the gut microbe flora.


Eligibility Criteria:
Inclusion Criteria:

* Identified female at birth
* aged 18-45
* diagnosed with endometriosis (radiologically (ultrasound or magnetic resonance imaging (MRI)) or surgically confirmed diagnosis of endometriosis)
* Able and willing to provide written consent to participate in the study.

Exclusion Criteria:

* History of or diagnosis of gynecologic or GI malignancy
* Post-menopausal
* Currently pregnant or lactating
* Dietary restrictions due to medical conditions (e.g., Celiac disease, allergies)
* People who are already following a formal anti-inflammatory diet.
Coronary and Heart Effects of Early Treatment in Familial Hypercholesterolemia

This study evaluates plaque burden and characteristics in early-treated FH patients compared to late-treated FH patients and healthy individuals.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosed with heterozygous familial hypercholesterolemia or non FH-control
* Adult patients between 25 and 55 years old.

Exclusion Criteria:

* Renal insufficiency, defined as eGFR \< 30 ml/min
* Atrial fibrillation
* Any other treatment or clinically relevant condition that could interfere with the conduct or interpretation of the study in the opinion of the investigator
* Inability or unwillingness to comply with the protocol requirements, or deemed by investigator to be unfit for the study.