cyrilzakka/clinical-trials huggingface dataset:
Balloon Inflation and Plaque Morphology in Revascularisation (BURST)

This study will look at the effects of standardised balloon inflation times, pressure and balloon types and atherosclerotic plaque morphology on the procedural results of percutaneous coronary intervention (PCI).

Patients presenting with symptoms of coronary artery disease (e.g. chest pain - angina) are often treated with stents (referred to as percutaneous coronary intervention, PCI). Stents treat the cause of symptoms by improving blood flow to the heart muscle through expanding a narrowed, or diseased segment within a coronary artery. The procedure involves the inflation of a balloon to expand the stent inside the artery. As part of standard clinical care multiple balloon inflations are required during the procedure. Deficiencies in the expansion of the stent at the time of the procedure are associated serious complications such as stent blockages or re-narrowing of the artery, either of which may not occur until much later.

Improvements to the technique of stent expansion are therefore highly desirable to improve outcomes for patients. A number of factors are thought to influence the success of the procedure, including: the type of balloon used to inflate the stent, the pressure used and the duration of balloon inflation. Another important factor may be the mechanical properties of the narrowed segment of the artery (plaque) and how they interact with the stent. At present however, there is no consensus view and the practise of individual cardiologists consequently remains highly variable.

The aim of this study is better characterise relationship between pressure and duration of balloon inflation, type of balloon used and plaque properties during stent procedures using state-of-the-art imaging. Although assessment of each of these factors by a cardiologist is already included as part of standard care, our research protocol will focus the analysis into a systematic framework to allow conclusions to be drawn. The findings will used better inform cardiologists of the technical modifications that can help improve stenting procedures and translate to better outcomes for patients.

Eligibility Criteria:
Inclusion Criteria:

* Patients with symptomatic coronary artery disease (stable angina, non-ST elevation acute coronary syndromes) undergoing percutaneous coronary intervention with intracoronary ultrasound (IVUS) guidance
* Patients \> 18 years
* De novo coronary stenoses in native coronary arteries
* Written informed consent

Exclusion Criteria:

* ST-elevation acute coronary syndrome
* Haemodynamic instability
* Cardiogenic shock
* Severe renal dysfunction (eGFR \< 30 ml/min/1.73m2)
* In-stent restenosis
* Chronic total occlusions
* Saphenous vein and arterial bypass grafts
* Patients who are currently enrolled in any other study where involvement in this study would involve significant deviation from either protocol
New Markers to Measure Clotting in Patients With the Obstructive Sleep Apnoea Hypopnoea Syndrome

Obstructive Sleep Apnoea Hypopnoea Syndrome(OSAHS)affects at least 4% of males and 2% of females.

OSAHS is the combination of excessive daytime sleepiness, snoring and apnoeas (stopping breathing at night). As well as affecting tiredness, mood, concentration and quality of life - there is growing concern that it can increase the risk of high blood pressure, heart problems, strokes and thromboses (clots in the veins).

It appears that OSAHS may affect the thickness of the blood and cause it to clot more easily it also causes damage to the lining of the blood vessels (endothelial injury). These effects seem independent of other risk factors such as obesity, smoking, family history of clots etc.

The investigators are testing new biomarkers: gel point and fractal dimension developed at the Swansea University to measure the 'clotting' of the blood in people with OSAHS and a similar group of people who snore and who are sleepy but do not have OSAHS on sleep studies (Controls) Also markers of vascular inflammation are being measured.

Primary objective:

The primary outcome of this study is to test the null hypothesis that no significant difference exists between fractal dimension (Df)and vascular injury markers including serum amyloid A (SAA), C-reactive protein (CRP), vascular cell adhesion molecule-1 (VCAM-1) and intercellular adhesion molecule-1 (ICAM-1)in patients with OSAHS and sleepy, snoring controls of similar age, gender and BMI.

Secondary objectives:

1. To test the null hypothesis that there is no significant difference in measured markers before and after a night's sleep in OSAHS and controls.
2. To test the null hypothesis that there is no significant difference in measured markers following 1 month of CPAP treatment, in those with OSAHS.

Eligibility Criteria:
Inclusion Criteria:

* 18-80 year old with h/o daytime sleepiness, snoring and apnoeas

Exclusion Criteria:

* Refusal to give written informed consent.
* Personal or family history of pro- thrombotic or bleeding disorders, severe liver disease (clotting problems) and those prescribed warfarin or heparin.
* Those with borderline sleep studies (4% Diprate or AHI 10-14 per hour).
* Aged less than 18 years or greater than 80 years.
An Observational Study of the Use and Safety of Xolair® During Pregnancy

The Xolair® Pregnancy Registry is an observational study established by Genentech to obtain data on pregnancy outcomes in women who are exposed to Xolair®. Women exposed to at least one dose of Xolair® within 8 weeks prior to conception or at any time during their pregnancy will be followed to completion of their pregnancies. The evaluation of infants will be conducted at birth and at 6-month intervals until the infants are 12 months old. Follow-up of the infant will be extended until the infant is 18 months old, if the woman continues Xolair® treatment while breastfeeding.


Eligibility Criteria:
Inclusion Criteria:

- Women who have been exposed to at least one dose of Xolair® (whether inadvertent or deliberate) within 8 weeks prior to conception or during pregnancy

Exclusion Criteria:

* Women not currently pregnant
* Women exposed to Xolair® not during pregnancy but only while breastfeeding
* Re-enrollment of women who are pregnant for second (or more) time is not allowed
Single-step Versus Sequential Media in Preimplantation Embryo Development and Pregnancy Rates

Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.

Sequential culture media were introduced in order to meet the changing requirements of the developing embryo in vitro. However, there has been renewed interest in the use of single-step media, which allow the embryo itself to choose the necessary nutrients while maintaining a more stable culture environment. Previous studies suggest that sequential media do not appear superior to single-step media.

The current study will include 2 RCTs:

RCT 1: Random allocation of sibling oocytes to compare embryo development and blastocyst formation rates in the two culture media compared.

RCT2: Random allocation of patients in either Global or Origio media, to evaluate pregnancy rates.

Eligibility Criteria:
Inclusion Criteria:

* \<40 years of age
* female infertility patients
* at least 10 retrieved oocytes

Exclusion Criteria:

* 41 years or older
* frozen-thawed oocytes/embryos
* oocyte donation cycles
Neurostimulation for the Relief of Acute Bronchoconstriction

The goal of this study is to validate design for the Resolve™ Stimulator and Proximity Electrode and the associated procedure to quickly and safely place an electrode into the neck, in the vicinity of the vagus nerve by a physician in either the Emergency Department or other appropriate hospital inpatient setting (e.g., ICU). The secondary goal is to confirm that the electrical signal being delivered via this electrode rapidly counters bronchoconstriction and improves airway flow.

The present study is to evaluate the safety of a new neurostimulator device, the Resolve Stimulator and Proximity Lead™, which comprises an external electrical signal generator coupled to temporary electrode that is percutaneously inserted in the neck.

Sponsor believes, based on animal testing data provided as well as consultations with physicians who regularly treat patients suffering from attacks of acute bronchoconstriction in ER and inpatient hospital settings, that this device could be used in the skilled care hospital setting to help rapidly relax the smooth muscle in the airway, relieving a clinically significant portion of the bronchoconstriction suffered by patients experiencing moderate to severe asthma attacks, allowing more effective delivery of inhaled medications to restore the patient to his or her baseline respiration status.

Eligibility Criteria:
Inclusion Criteria:

* Male / Female, Age 18-65
* Subject declares a medical history of asthma or sufficient prior clinical experience/records exists to confirm the subject has received a diagnosis of bronchoconstriction
* Completed \>1 hrs of conventional breathing and related medication treatments without improvement in FEV1 to \> 70% predicted
* Able to give Informed Consent

Exclusion Criteria:

* Scaring / abscess other problems with neck at electrode placement site
* Known or suspected carotid artery disease (i.e. bruits or history of stenosis)
* Suspected or confirmed coagulopathy
* Suspected or confirmed sepsis
* Irregular heart rate, rhythm
* Receiving pressors to maintain blood pressure
* Presently implanted electrical and/or neurostimulator device, including but not limited to cardiac pacemaker, vagal neurostimulator, deep brain stimulator, spinal stimulator, bone growth stimulator, or cochlear implant
* Allergy to local anesthetics used for placement of the lead
* History of lung cancer, emphysema, chronic obstructive pulmonary disease, or other comorbidity that might otherwise compromise the expected air flow volumes in the lungs
* At risk of imminent respiratory collapse

  * Lung Function: FEV1 \< 40% predicted
  * Signs and Symptoms: Extreme symptoms at rest, accessory muscle use, chest retraction
  * Alert State: Drowsy, confused
* Treatment with anti-cholinergic medications within 4 hours of enrollment
Observational Bronchoscopy Video Data Collection Study With Adult Patients

The primary aim is to develop a software algorithm that has the capacity to detect the normal 18 anatomical structures of the lung by using the position of the scope during the bronchoscopy procedure and using existing bronchoscopy technology.

A data collection of bronchoscopy videos from 100-150 patients are enrolled for getting image material of different lung anatomies, captured with CE-marked and FDA-approved Ambu bronchoscopes (Ambu® aScope™ 5 Broncho HD). No intervention will take place, only standard of care. All types of indications are enrolled. All patients were given oral and written information prior to participating, and signed consent was provided. No patient identifiable information is stored.

Eligibility Criteria:
Inclusion Criteria:

* Patients indicated for bronchoscopy of central airways as per standard of care
* Patients of 18 years or above

Exclusion Criteria:

* Lack of patient cooperation for bronchoscopy (e.g. patients with mental disorders, dysgnosia, psychological disorder)
* Patients unable or unwilling to give informed consent
Analysis of the French Balance and Daily Life (EVQ) Questionnaire for Evaluation of Balance in the Frail Elderly

The Balance and Daily Life questionnaire (EVQ) observes the adaption of the patient in six scenarios of daily life; it is a measurement of falls, but also an evaluation of the modifications taken to prevent future falls. This study will analyze the robustness of this questionnaire.


Eligibility Criteria:
Inclusion Criteria:

* The patient must have given their free and informed consent and signed the consent form
* The patient must be a member or beneficiary of a health insurance plan
* The patient is at least 65 years' old
* The patient is fragile (\< 8 score ≤ 11 SEGA score) hospitalized in the Physical Medicine and Functional Geriatric Readaptation service of the CHU Nîmes
* The patient can walk autonomously for 20m (with or without a walking aid)
* The patient is allowed to weight-bear

Exclusion Criteria:

* The subject is participating in an interventional study, or is in a period of exclusion determined by a previous study
* The subject refuses to sign the consent form
* It is impossible to give the subject informed information
* The patient is under safeguard of justice or state guardianship
* The patient is forbidden to weight-bear
* Comprehension problems preventing the accomplishment of the tasks
* Major short-term memory problems preventing the accomplishment of the tasks
A Phase II, Dose Ranging Study Of CP-690,550 Eye Drops In Patients With Dry Eye Disease

The purpose of the study is to evaluate dose-response, efficacy and safety of CP-690,550 eye drops in patients with dry eye disease.


Eligibility Criteria:
Inclusion Criteria:

* Subjective symptoms of dry eye for at least 6 months
* Signs of moderate to severe dry eye (corneal staining score and schirmer test without anesthesia)

Exclusion Criteria:

* Women who are nursing, pregnant or planning pregnancy during the study
* Participation in other studies within 30 days of screening visit
* Ocular disorders that may confound interpretation of study results
Study Evaluating the Efficacy and Safety of OCS-01 Eye Drops in Subjects Following Cataract Surgery

The goal of this clinical trial is to evaluate the efficacy and safety of OCS-01 in treating inflammation and pain in subjects following cataract surgery.

This is a multi-center, randomized, double-masked, vehicle-controlled study, designed to evaluate the efficacy and safety of OCS-01 compared to vehicle in treating inflammation and pain following cataract surgery. Subjects will be randomized 1:1 to receive OCS-01 or vehicle once daily.

Eligibility Criteria:
Inclusion Criteria (Selection):

* Provide written informed consent, approved by the appropriate ethics committee;
* Able to comply with the study requirements and visit schedule;
* At least 18 years of age of either sex or any race;
* Will undergo unilateral cataract extraction via phacoemulsification and PCIOL implantation in the study eye;
* Have an anterior chamber cell score ≥ 2 at Visit 2 (Day 1 \[18 to 30 hours post- uncomplicated cataract surgery without vitreous loss\]);

Exclusion Criteria:

* Have a known sensitivity or allergy to dexamethasone, corticosteroids, or any of the study medication's components;
* Have only one functional eye (monocular);
* Have any intraocular inflammation (e.g., white blood cells or flare) present in either eye at the Visit 1 (Day -1 to Day -28 \[prior to surgery\]) slit-lamp examination;
* Have a score \> 0 on the Ocular Pain Assessment at Visit 1 (Day -1 to Day -28 \[prior to surgery\]) in the study eye \*Additional inclusion/exclusion criteria apply
Early and Late Prognosis in Patients With Guillain-Barre Syndrome

The goal of this observational study is to explore significant indicators to predict the early prognosis and late prognosis in patients with Guillain-Barre syndrome.

This is a multicenter study(approximately three) with over 450 subjects.Clinical data were collected by consulting the patient's electronic history. The data included demographic information, blood biochemical markers, clinical characteristics and electromyography. All participants provided their written informed consent to participate in this study.

Eligibility Criteria:
Inclusion Criteria:

* patients fulfilled clinical, biological, and electrophysiology criteria for Guillain-barre syndrome.

Exclusion Criteria:

* nonidiopathic Guillain-barre syndrome and Miller Fisher syndrome
Prevalence of Dental Anomalies in Oral Clefts Patients

To assess the prevalence of dental anomalies in the deciduous dentition in children with oral clefts and to investigate the associated risk factors.

Oral clefts lip and/or palate are considered as the most common oro-facial defects in children with an unclear complex etiology.

The international prevalence in newborns was estimated as 14 per 10,000 live births worldwide. Around 70% of cases occur as a non-syndromic cleft lip and/or cleft palate (NSCL/P)\], and the resting 30% are associated with Mendelian disorders or teratogenic, chromosomal and sporadic conditions.

Non syndromic cleft lip and/or palate divided into cleft lip (CL), cleft lip and palate (CL/P) and cleft palate (CP) based on epidemiological features and embryologic timing.

The exact etiology is not completely known, but attributed to a mixture of genetic and environmental factors. The usefulness of epidemiological knowledge is important in assessing the burden of oral clefts in order to plan public health resources. Also, knowing the causes of oral clefts, which stimulates research on primary prevention and treatments to improve the quality of health and care.

The incidence of dental defects in cleft patients can be used as clinical indicators for defining cleft sub-phenotypes, as well as providing numbers of instances.

Dental anomalies in children can lead to an increased risk of dental problems from esthetic to orthodontic problems. In Egypt, there is lacking of information on the occurrence of dental defects in the deciduous dentition of children with oral clefts. Also oral clefts are complicated epidemiological condition and further investigations are needed to know about the risk factors of this situation.

Eligibility Criteria:
Inclusion Criteria:

* Children with oral cleft lip and/or palate with ages varying from 4 to 6 years.
* Children with primary dentition.
* Parents who accept to participate in the study.
* Compliant children.

Exclusion Criteria:

* Healthy children and their guardians
* Syndromic oral clefts children
Efficacy and Safety Study of TAS5315 Compared With Placebo in Participants With Rheumatoid Arthritis.

The purpose of this study is to assess the efficacy and safety of TAS5315 in combination with methotrexate in a 12 week or 36 week in participants with rheumatoid arthritis with inadequate response to methotrexate.


Eligibility Criteria:
Inclusion Criteria:

* Have a diagnosis of RA according to 2010 ACR/ EULAR rheumatoid arthritis (RA) classification criteria
* Have been treated with methotrexate (MTX) for at least 90 days prior to screening, and must be on a stable dose between 8 and 16 mg/week for at least 56 days prior to screening.
* Have an inadequate response to MTX
* Have a minimum of 6 swollen and 6 tender joints from 66/68 joint count
* Have hsCRP of ≥ 0.6 mg/dL

Exclusion Criteria:

* Have been treated with conventional synthetic disease-modifying anti-rheumatic drug, except for MTX, within 28 days prior to randomization
* Have an inadequate response to biologic disease-modifying anti-rheumatic drug or Have been treated with 2 biologic treatment
* Have been treated with Janus Kinase inhibitors or other Bruton's Tyrosine Kinase inhibitors
* Have a positive result for hepatitis B surface antigen/antibody, hepatitis B core antibody, hepatitis C virus antibody or human immunodeficiency virus antigen/antibody at screening
* Have been treated with Oral steroids at dose above 10 mg/day of prednisone or prednisone equivalents
* Have a diagnosis of Felty's syndrome
* Have a positive result of the QuantiFERON®-tuberculosis (TB) Gold test or a T-spot ®-TB test at screening
* Have a positive result of β-D-glucan at screening
Echocardiography Findings and Perioperative Outcomes in Children

This study evaluates the association between perioperative echocardiographic Doppler findings and clinical outcomes in pediatric patients undergoing cardiac surgery. In our center, anesthesiologists perform transthoracic or transesophageal echocardiography during perioperative period routinely in children undergoing surgery for congenital cardiac disease. Echocardiographic findings include the doppler patterns of hepatic vein, portal vein, renal artery, renal vein and splenic vein before and after cardiopulmonary bypass. Portal pulsatility index, renal resistive index, and respiratory variations in peak aortic blood flow velocity and diameter of inferior vena cava are measured.


Eligibility Criteria:
Inclusion Criteria:

* All pediatric patients undergoing cardiac surgery

Exclusion Criteria:

* Applying extracorporeal membrane oxygenator prior to surgery
* Trouble applying echocardiography
Ventilation With Supraglottic Airway Devices

Airo-Q Self Pressurized airway device with Blocker will be compared with Proseal LMA in anesthetized adult female patients undergoing elective surgeries to discuss the influence of different head and neck positions on the performance of both devices. Oropharyngeal leak pressure, peak inspiratory pressure, ventilation score and fiber-optic view will be assessed in neutral, flexion, extension and lateral positions in both groups.


Eligibility Criteria:
Inclusion Criteria:

* Adult female patients ASA I\&II.
* age: 18-55 years old.
* BMI\< 35.
* undergoing elective surgeries.

Exclusion Criteria:

* Patients with history of upper respiratory tract infections and obstructive sleep apnea.
* Patients who are potentially full stomach such as trauma, pregnancy, history of gastric regurgitation \&heart burn, those with esophageal reflux or hiatus hernia.
* Patients with coagulation disorders.
* Patients with El-Ganzouri airway score ≥ 5 will.
Pilot Trial of CenteringPregnancy With Mindfulness Skills

In the U.S., rates of preterm birth and low birth weight have increased over the past 30 years. Poor birth outcomes are especially high among racial/ethnic minority populations. Maternal stress is an important factor that can lead to negative birth outcomes. Thus, programs that reduce stress during pregnancy could improve birth outcomes. Initial pilot work tested a mindfulness-based approach to stress reduction during pregnancy. Women in the pilot study had lower stress and improved coping after the program. For the current study, mindfulness is added to an existing prenatal healthcare program called CenteringPregnancy (CP). CP provides prenatal care through 10 group sessions. This study compares CP with a version of CP infused with mindfulness skills training. Effects of the two versions of CP on psychological stress and coping, stress hormones, and birth outcomes will be tested. Data will be collected from participants three times: twice during pregnancy and once after birth. Medical records will provide data on birth outcomes and other health factors. The study will provide initial information about a mind-body program to reduce stress and improve birth outcomes. Data from the study will inform the development of an R01 proposal for a larger study. The study will also help advance the long term goal of reducing health disparities.


Eligibility Criteria:
Inclusion Criteria:

* age 18 and over
* enrolled to receive group-based prenatal healthcare from the San Francisco General Hospital (SFGH) Outpatient Midwifery Clinic CenteringPregnancy program

Exclusion Criteria:

* ineligible for CenteringPregnancy due to the need for individualized prenatal care
* Type 2 diabetes
* HIV
* seizure disorder
* serious mental health disorder
* substance abuse or medical condition that would lead to inability to adhere to intervention guidelines
* not fluent in English or Spanish
* previous formal training in meditation, yoga, or other mind-body practice
* previous participation in CenteringPregnancy