cyrilzakka/clinical-trials huggingface dataset:
Sonoelastography of the Uterine Cervix Before Induction of Labor

The investigators aim to measure sonoelastographically the elasticity of the uterine cervix in pregnant patients at term before induction of labor and compare between patients with successful and failed inductions.

Softening of the uterine cervix in pregnant patients at term causes changes in its elasticity.these changes may affect success or failure in induction of labor.The elasticity of the uterine cervix is usually evaluated clinically and subjectively by vaginal examination (bishop's score) which is not very predictive.We aim to measure the elasticity quantitatively and objectively.The difference in strain, in the area of the internal os , is often illustrated by a color map, where low stiffness (soft tissue) is indicated in red, middle stiffness is in green and high stiffness (hard tissue) is in blue.The color maps will be compared between patients with successful and failed inductions.

Eligibility Criteria:
Inclusion Criteria:

* pregnant patients before induction of labor

Exclusion Criteria:

* pregnant patients undergoing caesaren section following induction of labor not in active labor
Does Stress Change EEG Measures in Students: A Feasibility Study

Psychological stress is a frequent human affection and has a considerable impact on modern society, and tertiary-level students often report increased stress levels as the semester progresses. While many questionnaires assess psychological stress, they do not capture objective data. Much research has shown that electroencephalography (EEG) can capture objective markers of stress, and recent studies have shown that EEG can even classify stress levels.

This study aims to assess the feasibility of using EEG to objectively assess stress over the course of a semester of work in chiropractic students engaged in a Masters level course in Scotland.

The study's primary aim is to assess the feasibility of a more extensive future study. The investigators also hypothesise that as the semester progresses, participants will exhibit changes in their EEG outcomes that may be related to longitudinal or direct stressors.

Study design and setting This study will be an observational study with a stress-related questionnaire (Depression, Anxiety, and Stress Scale - 21 (DASS-21)) over three time-points.

Participants The investigators aim to recruit 10 participants and assess them three times over the course of their semester, early, middle, and late semester, with at least a four-week gap between each data collection. The investigators aim to recruit only healthy Scottish chiropractic students with no prior diagnosed mental disorder and who are capable of understanding the study procedure.

Procedure Following screening for eligibility and consent, i.e., visit one (baseline), participants will be asked to answer a questionnaire and undergo EEG measurement and Montreal imaging stress task (MIST). The same EEG and questionnaire procedure will be performed in the remaining two data collection sessions.

Each EEG recording session, with the participant seated, will consist of a two-minute resting state with the eyes closed for a baseline relaxation level among the participants. A following two-minute eyes-open phase will take place. After which, participants will be asked to perform the experimental phase of the MIST task, a following two-minute recording phase will be with the eyes open, and a final two-minute resting phase with eyes closed will conclude the task.

The investigators aim to conclude the data collection around 16 weeks after the initial participant is recruited.

Eligibility Criteria:
Inclusion Criteria:

Healthy Scottish chiropractic students with no prior diagnosed mental disorder and who are capable of understanding the study procedure.

Exclusion Criteria:

A pre-diagnosed mental health disorder
Pulmonary Vein Isolation in Athletes

Pulmonary vein isolation (PVI) has become a common and effective treatment for paroxysmal and persistent atrial fibrillation (AF), particularly in patients with drug-refractory disease. Intense endurance exercise is a known risk factor for atrial fibrillation. In general, these athletes poorly tolerate most common antiarrhythmic drugs used for atrial fibrillation control and often PVI is recommended for durable management. While the efficacy of PVI in athletes is similar to the general AF population, some athletes with lone atrial fibrillation report a reduction in subjective exertional capacity following PVI, despite maintenance of sinus rhythm and absence of pulmonary vein stenosis on imaging. The investigators hypothesize that PVI may alter pulmonary vein function and affect peak exercise performance.

The investigators propose a small, prospective study of endurance athletes undergoing antral PVI for treatment of lone atrial fibrillation. Peak metabolic performance and pulmonary vein function will be assessed pre- and post-PVI by metabolic stress testing and cardiac MRI, respectively.

Endurance athletes with paroxysmal or persistent atrial fibrillation undergoing primary pulmonary vein isolation will be prospectively enrolled prior to PVI.

Patients will undergo metabolic exercise stress testing as well as resting CMR 1-4 weeks prior to PVI. Metabolic stress testing and CMR will be repeated at 6 month follow-up. Quality of life questionnaires will also be collected at pre- and post-PVI visits. Metabolic treadmill stress testing will follow standard protocol and measure hemodynamics with escalating metabolic output and characterize peak exercise capacity (METs) and oxygen consumption (VO2 max).

CMR evaluation will include standard anatomic imaging of pulmonary vein and left atrial anatomy at rest. Additional cine CMR sequences willbe included for focused evaluation of dynamic pulmonary vein cross-sectional area. 3D navigator whole heart imaging and MRA (single gadolinium dose) will be obtained to measure pulmonary vein flow. CMR sequences to characterize left atrial function, including phasic volumes and emptying fractions (total, passive, active) will also be performed.

Data on heart rate variability will additionally be collected at pre- and post-PVI clinic visits, as well as the morning after PVI (hospital day 1).

Eligibility Criteria:
Inclusion Criteria:

* Paroxysmal or Persistent AF
* Endurance or highly trained athletes (\>3H training/week for \>10 yrs)
* NSR at time of stress testing

Exclusion Criteria:

* Structural Heart Disease; LVEF \<45%
* Moderate or Severe Valvular disease
* eGFR \< 30
* Contraindication to MRI
* Less than average functional capacity
* Previous episode of AF of \>14 days duration
* Previous pulmonary vein isolation
* Imaging evidence of pulmonary vein stenosis
Non-pharmacologial, Non-invassive Intervention Before Cardiac Surgery: a Randomized Controlled Trial

Perioperative neurological complications in cardiovascular surgical procedures are associated with a significant risk of mortality and disability. The goal of this clinical trial is to learn if ischemic preconditioning and transcranial electrical stimulation to reduce perioperative neurological complications. It will also learn about the safety of remote ischemic preconditioning and transcranial electrical stimulation before cardiac surgery. The main questions it aims to answer are "Do remote ischemic preconditioning and transcranial electrical stimulation make good effect on perioperative neurological complications?" "Are remote ischemic preconditioning and transcranial electrical stimulation safe?" Researchers will compare remote ischemic preconditioning and transcranial electrical stimulation to traditional treatment to see if remote ischemic preconditioning and transcranial electrical stimulation work to reduce perioperative neurological complications.

Participants will:Undergo remote ischemic preconditioning and transcranial electrical stimulation or sham treatment twice every day for 3 days before surgery.

Undertake psychological assessment and clinical symptom follow-up after cardiac surgery.


Eligibility Criteria:
Inclusion Criteria:

1. Age range: 18-80 years old;
2. Surgical patients with heart disease;
3. Elective surgery;
4. Patients identified as high-risk for postoperative neurological complications; Previous stroke history; Moderate to severe stenosis of the head and neck arteries was evaluated;
5. Be able to understand and comply with the requirements of clinical trial protocols, and voluntarily sign informed consent forms.

Exclusion Criteria:

-
Randomized Control Trial of Intraperitoneal Bupivacaine During Cholecystectomy

Laparoscopic cholecystectomy (removal of the gall bladder via 'keyhole surgery') is a common procedure. This can be performed as an emergency operation when a patient has a complication of gall stones such as acute inflammation or pancreatitis. There are several trials which demonstrate that placing local anaesthetic inside the abdomen at the site of gall bladder surgery during a planned elective operation decreases post operative pain. This is the first trial to investigate the efficacy of this local anaesthetic during emergency cholecystectomy.

Background Several studies, including a metanalysis, have demonstrated that intraperitoneal local anaesthetic (IP LA) during elective laparoscopic cholecystectomy (el-LC) decreases post operative pain. None have explored the efficacy of IP LA at emergency laparoscopic cholecystectomy (em-LC). A longer operation duration, greater frequency of washing and the inflammation associated with cholecystitis or pancreatitis are a few reasons why it cannot be assumed that a benefit in pain scores will be seen in em-LC with IP LA. This study assesses the efficacy of IP LA used in patients undergoing em-LC.

Methods Double blind randomised sham controlled trial of 42 consecutive subjects undergoing em- LC.

IP-LA was delivered by a combination of direct injection to the diaphragmatic and topical wash over the liver/gall bladder with bupivacaine or sham depending upon allocation. The primary outcome was VAS pain scores on the ward. Secondary outcomes included VRS pain scores in theatre recovery, analgesic use, physiological observations, time to eating and ambulation and length of postoperative stay.

Results One patient had a procedure converted to open and was excluded. There was no significant difference in pain scores on the ward or in theatre recovery. Analgesic use, respiratory rate, oxygen saturation, duration to ambulation, eating, satisfaction scores and time to discharge were comparable between the groups.

Conclusions Intraperitoneal LA during em-LC does not influence post-operative pain. Other modalities of analgesia should be explored as well as decreasing the interval between diagnosis of acute admission and em-LC.

Eligibility Criteria:
Inclusion Criteria:

* patients undergoing emergency cholecystectomy for cholecystitis or gall stone pancreatitis

Exclusion Criteria:

* patients undergoing planned elective cholecystectomy
In Vitro Maturation With in Vitro Fertilization (IVF) Compared to Mild in Vitro Fertilization

Methods of infertility treatment may involve in vitro fertilization or IVF. Though effective, IVF is complex and expensive. Methods using no gonadotropin hormone stimulation of the ovaries are being compared to mild stimulation doses. The goal of the research is to determine which of these if more suitable as a low cost approach for varying individual patients.

Low cost environment is utilized, but fees are charged.

Eligibility Criteria:
Inclusion Criteria:

* Under age 42 female, normal uterine cavity, BMI 18-34kg/m2,

Exclusion Criteria:

* Donor eggs, donor sperm, myoma over 5 cm
* Current hydrosalpinx, abnormal uterine cavity.
Correlation of Flicker Induced and Flow Mediated Vasodilatation in Patients With Endothelial Dysfunction and Healthy Volunteers.

A couple of studies have shown that illuminating the eye with diffuse flickering light is accompanied by an increase of retinal vessel diameters, optic nerve head blood flow and retinal blood flow. We have recently used this visual stimulation technique as a new and powerful tool for the non-invasive investigation of vascular reactivity. Additionally, we could show that this response is diminished in patients with vascular pathologies and that the response is dependent on nitric oxide, indicating that flicker induced vasodilatation may reflect endothelial dysfunction and may be a new approach to test endothelial function in vivo.

One of the most widely used method for the assessment of endothelial function is flow mediated dilatation (FMD). FMD has been shown to give a reliable estimate of vascular function in vivo. In the present study, we set out to compare the standard method for the evaluation of endothelial function, FMD, to flicker induced vasodilatation in the retina.


Eligibility Criteria:
Inclusion Criteria:

Patients with diabetic retinopathy:

* Men and women aged \> 18 years.
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant.
* Inclusion criteria of patients are insulin dependent diabetes mellitus (IDDM) with non or mild non-proliferative diabetic retinopathy. Patients with no signs of diabetic retinopathy (level 1) or patients with one or more microaneurysms (level 2) will be included. Level of diabetic retinopathy will be assessed according to the criteria defined in the AREDS-study.(1991)
* serum cholesterol \< 250 mg/dl (treated or untreated)

Patients with mild hypertension and/or hypercholesterinemia:

* Men and women aged \> 18 years.
* mild essential hypertension defined as a blood pressure meeting the criterion of hypertension grade 1 of the World Health Organisation blood pressure classification
* systolic blood pressure between 140 and 159 mmHg and diastolic blood pressure between 90 and 99 mmHg and/or
* serum cholesterol \> 250 mg/dl
* blood pressure will be measured at two different occasion in a sitting positions

Healthy subjects:

* Men and women aged \> 18 years.
* Normal findings in the medical history unless the investigator considers an abnormality to be clinically irrelevant
* normal ocular findings
* serum cholesterol \< 200 mg/dl
* systolic blood pressure between 110mmHg and 140mmHg
* diastolic blood pressure \< 90 mmHg

Exclusion Criteria:

* Abuse of alcoholic beverages, participation in a clinical trial in the 3 weeks preceding the study
* Symptoms of a clinically relevant illness in the 3 weeks before the first study day
* Blood donation during the previous 3 weeks
* other ocular pathologies than diabetic retinopathy level 1 or 2
* History or family history of epilepsy
* Ametropy greater or equal than 3 dpt
* systolic blood pressure \< 100mmHg
* diastolic blood pressure \< 75mmHg
* pregnant or lactating women
The Effect of Hypertension Medications on Renal Blood Flow Measurements in Healthy Males (MK-0000-127)

This study will evaluate the effect of Aliskiren and Losartan on renal blood flow using PAH clearance, PC MRA and ASL MRI methodologies.


Eligibility Criteria:
Inclusion Criteria:

* Subject is in generally good health
* Subject is willing to avoid unaccustomed strenuous exercise during the study
* Subject agrees to consume ONLY the study-specified diet during all domiciled periods
* Subject has been a non-smoker for at least 3 months prior to study
* Subject will refrain from smoking or using any tobacco products during the study
* Subject agrees to refrain from consuming alcohol or caffeine during the domiciled periods and agrees to limit alcohol and caffeine consumption throughout the study

Exclusion Criteria:

* Subject has contraindication to MRI scans
* Subject has a history of stroke, seizure, or major neurological disorders
* Subject uses illicit drugs or has a history of drug/alcohol abuse
* Subject has had major surgery, has donated or lost 1 unit of blood, or has been in another investigational study in the last 4 weeks
* Subject has a history of multiple and/or severe allergies to drugs or food
Quantitative Assessment of Autologous Fat Transfer

This is a single-arm, prospective pilot study that will objectively assess outcomes in patients electively undergoing Autologous Fat Transfer (AFT) for breast or chest wall reconstruction. Patients planning to undergo autologous fat transfer for breast or chest wall reconstruction will be enrolled prospectively. Participants will undergo standard photographs (2-D imaging) of their chest wall and torso, including the breasts, and complete a validated questionnaire (BREAST-QTM) to evaluate patient satisfaction, and quality of life, all standard of care. The 3D photographs, Magnetic resonance imaging (MRI), and Ultrasound (US) are routinely used in practice but will be performed for research purposes in this study. All imaging procedures and questionnaires will be obtained at baseline and follow-up visits 3-6.

The purpose of this pilot study is to assess the utility of imaging (photographs, ultrasound (US), and Magnetic resonance imaging (MRI) )to follow outcomes of autologous fat grafting to the chest for reconstruction. The study team will compare images obtained from each of these methods (photographs, ultrasound, and MRI) to visualize changes in the breast over time.

All participants will meet with a member of the research staff at a pre-operative appointment in the Center for Reconstructive Surgery. At Visit 1 participants will be consented, undergo research-specific data collection, surveys, US, MRI scan, 2D photographs, and 3D surface scanning of their torso/breast.

During follow-up Visits 3-6, participants will undergo research-specific 2D photographs and 3D surface scanning of their breast and chest wall. Participants will also have an ultrasound and MRI scan performed during follow-up visits 4-6 in addition to completing a questionnaire to evaluate patient satisfaction and quality of life following fat grafting.

After obtaining a Data Use Agreement (DUA), de-identified photographs and 3D scans of the participants' torsos (area of fat grafting) will be shared with the University of Houston (Dr. Fatima Merchant) to analyze using software developed to look specifically at volume of the breast before and after surgery and compare the 3D photos with the MRI data. No protected health information (PHI) will be shared with the University of Houston or other investigators.

During each clinic visit, relevant data will be extracted from Epic and entered manually into REDCap data forms by a member of the research team.

Eligibility Criteria:
Inclusion Criteria:

Age of 18 years or older

* Planned autologous fat transfer or fat grafting reconstruction of the breast or chest wall.
* Able to provide written or electronic informed consent.
* Able to undergo MRI.

Exclusion Criteria:

* Vulnerable subjects (children, prisoners, pregnant women).
* Patients who have active cancer, metastatic disease, solid organ transplantation / immunosuppression, or autoimmune diseases.
* Unable to undergo MRI (history of metal contraindication, claustrophobia)
Comparative Effectiveness of Antibiotics for Respiratory Infections

The purpose of this study is to identify and use patient centered outcomes to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common acute respiratory tract infections (ARTIs) in children.

Outpatient, ARTIs account for the vast majority of antibiotic exposure to children, and roughly half of these antibiotic prescriptions are inappropriate. Although unnecessary antibiotic prescribing for viral infections has significantly decreased, there has been a substantial increase in prescribing of broad-spectrum antibiotics to treat ARTIs when narrow-spectrum antibiotics are indicated. Primary care providers, patients, and caregivers would benefit from studies assessing the implications of alternate antibiotic regimens for these common infections. Specifically, it remains unclear if treating common ARTIs with broad-spectrum antibiotics leads to an improvement in patient outcomes compared to treatment with narrow-spectrum antibiotics, particularly considering the increasing threat posed by antimicrobial resistance. Because of the lack of large comparative effectiveness studies with patient-centered outcomes addressing this issue, professional guidelines and expert recommendations are conflicting, and, as a result, practice patterns vary considerably. Therefore, using patient-centered outcomes, we aim to compare narrow-spectrum and broad-spectrum antibiotics for the treatment of common ARTIs in children. To accomplish this, we will perform a prospective cohort study of children receiving antibiotics for ARTI across a comprehensive pediatric healthcare network. We will conduct telephone interviews with parent's of children who receive antibiotic treatment for an ARTI. We will assess previously identified patient-centered outcomes included a health-related quality of life measure, occurrence of side effects, missed school/daycare, parent missed commitments and/or required additional childcare and symptoms were still present on day 3 after diagnosis.

Eligibility Criteria:
Inclusion Criteria:

We included children between six months and 12 years old, diagnosed with an ARTI (acute otitis media, acute sinusitis, Group A streptococcal \[GAS\] pharyngitis) using International Classification of Diseases diagnosis codes and prescribed an antibiotic. For GAS pharyngitis, the child also had a positive rapid streptococcal test.

Exclusion Criteria:

* Diagnosed with multiple ARTIs
* Diagnosed with another non-ARTI bacterial infection
* Prescribe antibiotics in the past 30 days
* Non-English speaking families
* If GAS pharyngitis diagnosis, age \< 3 years
A Multiple Ascending Dose, Phase 1b Study of YH35324 in Atopic Healthy Subjects or Subjects With Allergic Diseases

This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with allergic diseases, who have atopy.

YH35324 is a drug under development as a novel therapeutic agent for various IgE-mediated allergic diseases. Since YH35324 has a high binding affinity to human IgE, it prevents serum IgE from binding to receptors on mast cells and basophil, thereby inhibiting histamine release caused by degranulation when exposed to allergens. This study aims to evaluate the safety, tolerability, pharmacokinetic (PK) and pharmacodynamic (PD) profiles following multiple subcutaneous injections of YH35324 in healthy subjects or subjects with allergic diseases, who have atopy.

Eligibility Criteria:
Inclusion Criteria:

* Male or female adults aged ≥ 19 to ≤ 55 years(Cohort 5, Mald or female adults ≥ 19)
* Serum total IgE level ≥ 30 IU/mL or 30 to 700 IU/mL or \>700IU/mL(Not Applicable for Cohort 5)
* Meeting the following cohort-specific disease severity criteria \[Cohorts 1-4\]: Healthy subjects without any pathological symptoms or findings from medical examination, or subjects with a history of mild allergic diseases (allergic rhinitis, atopic dermatitis, food allergy, urticaria, or allergic asthma) \[Cohort 5\]: Subject who have been diagnosed with moderate to severe atopic dermatitis

Exclusion Criteria:

* History of malignancy
* Positive drug screen result
* transaminase (AST) or alanine transaminase (ALT) level \> 2 X the upper limit of normal
* Estimated glomerular filtration rate (eGFR) \< 60 mL/min/1.73 m2 using the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula
* Allergy immunotherapy initiated or changed within 6 months prior to randomization(For Cohort 5, within 12 months prior to randomization)
* History of participation in another clinical trial within 6 months prior to randomization