cyrilzakka/clinical-trials huggingface dataset:
Assessment of Cardiac Output With EtCO2

Hemodynamic monitoring, especially cardiac output assessment, is a key feature for the management of critically ill patients. Although the use of invasive methods, such as thermodilution with a pulmonary artery catheter, remains the GOLD standard for the evaluation of the cardiac output, several non-invasive techniques are currently used in practice. An acceptable estimation of the cardiac output can be made by standard transthoracic echocardiography. Cardiac output can be calculated from subaortic velocity time integral (VTI). However, this technique requires a trained operator and depends on the echogenicity of the patient. The best method for assessing cardiac output depends on the patient's needs, the clinical scenario and the physician's experience with the monitoring device itself. No simple and rapid tool currently exist for assessing cardiac output in critically ill patients.

The measurement of end-tidal carbon dioxide (EtCO2) used in routine in critically ill patients requiring mechanical ventilation could be an interesting alternative. Indeed, the amount of carbon dioxide (CO2) exhaled depends on the production of CO2 by the body, the pulmonary blood flow (corresponding to cardiac output) and its elimination by alveolar ventilation. In controlled ventilation, ie for constant alveolar ventilation, EtCO2 should therefore depend only on cardiac output. It has been shown in a porcine model that EtCO2 and cardiac output are strongly related under stable respiratory and metabolic conditions. In humans, only the variation of EtCO2 after volume expansion has been studied and EtCO2 seems to reflect changes in cardiac output. Nevertheless, the usefulness of EtCO2 in assessing cardiac output has never been evaluated.

The objective of this study is therefore to determine the relationship between EtCO2 and cardiac output evaluated by the measurement of subaortic VTI in critically ill patients.


Eligibility Criteria:
Inclusion Criteria:

* patients intubated and ventilated in the control assisted mode with no inspiratory effort
* requiring vasopressors

Exclusion Criteria:

* less than 18 years
* refuse to participate
* situation in which health condition, medication or procedure could significantly interfere with the interpretation of EtCO2 or cardiac output (extracorporeal life support, pneumothorax with persistant air leak)

(be increased without correlation to an infectious process (poly-traumatised patients,
Penicillin Allergy Testing and Resensitization Rate

Penicillin is one of the earliest discovered antibiotics and a drug of choice for several infections. Up to 10 to 20% of all patients in clinical trial are labeled as penicillin allergic. Most of these patients do not have a true allergy but few have had it verified. Approximately 80% of patients with IgE-mediated penicillin allergy lose their sensitivity after 10 years. Several studies have been conducted denying the risk of sensitization following negative testing of penicillin allergy. Investigators have not had the same experience and have therefore decided to conduct a retrospective study review of 83 adult outpatients with a distant penicillin allergy label and evaluate outcomes of skin retesting six weeks following Drug Provocation Test and challenge.


Eligibility Criteria:
Inclusion Criteria:

- 18 years old

Exclusion Criteria:

* Pregnancy
* poorly controlled asthma and cardiovascular disease
* use of drugs that interfere with testing and could not be stopped such as antihistamines, tricyclic antidepressants, antipsychotics, beta blockers, high dose oral glucocorticoids
* Non-IgE mediated type of serious allergic reaction such as Stevens - Johnson syndrome, Toxic Epidermal Necrolysis, and Drug Rash with Eosinophilia and Systemic Symptoms (DRESS) Syndrome.
Effect of Food on the Bioavailability of 15 mg Estetrol/3 mg Drospirenone Tablets in Healthy Female Volunteers

This single-center, open-label, randomized, balanced, single-dose, two-treatment, two-period, two-sequence crossover study was conducted under medical supervision in 28 healthy female volunteers.

Food effect bioavailability studies are usually conducted for new drugs and drug products to assess the effect of food on the rate and extent of absorption of a drug when the drug product is administered shortly after a meal (fed conditions), as compared to administration under fasting conditions. Therefore, this study was designed to characterize the effect of a high fat meal on the bioavailability of E4 and DRSP after administration of a single tablet containing 15 mg E4 and 3 mg DRSP.

All subjects entered the study site at least 12 hours before each dosing and fasted for at least 10 hours prior to each dose.

All subjects were to receive both Treatment A (Reference; a single 15 mg E4/3 mg DRSP tablet without food (fasted)) and Treatment B (Test; a single 15 mg E4/3 mg DRSP tablet with food (fed)) either at the first treatment period (Period 1) or the second treatment period (Period 2). Approximately half of the subjects were randomized to receive either Treatment A followed by Treatment B (Sequence AB), or Treatment B followed by Treatment A (Sequence BA).

Eligibility Criteria:
Inclusion Criteria:

* Overtly healthy females.
* Between the ages of 18 and 45 years, inclusive.
* Non-smokers who have not used tobacco or nicotine in any form during the 3 months prior to the screening visit.
* Between the body mass index (BMI) of 18 and 30 kg/m2, inclusive, and body weight 45kg.
* Negative serum pregnancy test results at screening and negative urine pregnancy test results before dosing.
* Willing to use double-barrier methods of non-hormonal contraception during the entire study period.

Exclusion Criteria:

Potential study subjects were not entered into and/or may have been discontinued from the study if any of the following applied:

* Use of

  * progestogen-only contraceptive methods \[e.g., minipill, implant or, intrauterine system (IUS)\] during the last 3 months prior to the first dose or,
  * depot progestogen preparations or an injectable hormonal method of contraception (e.g., Depo-Provera) during the last 6 months prior to the first dose.
* Use (within 28 days prior to first dose) of other hormonal contraceptive method.
* Use of

  * any prescription drugs (except thyroid hormone supplements) or herbal supplements acting on CYP3A4 functions (e.g., St. John's Wort), within 28 days prior to the first dose until study completion,
  * any over-the-counter (OTC) medication (including paracetamol) or dietary supplements (vitamins included) within 14 days prior to the first study dose until study completion.
"In Vivo" Comparison in Human Carotid Atherosclerosis: Plaque Neovascularization

Atherosclerosis may initiate early in life and takes years to progress. This contrasts to the abrupt coronary or cerebrovascular events occurring following the transition from a stable to an unstable atherosclerotic plaque. The causes of this discontinuity of the disease are complex and probably multiple. There is increasing evidence that, besides inflammation, neovascularisation of atherosclerotic plaques and intra-plaque hemorrhages play an important role in plaque instability ending-up frequently in acute thrombotic occlusion or distal embolisation of athero-thrombotic material associated with heart attack or stroke. Contrast-enhanced Ultrasound, is a bed-side non-invasive technique, which allows to enhance microvascular structures and to visualize the adventitia and intraplaque vascularization. Dynamic contrast-enhanced plaque MRI (DCE-MRI) which has also been evaluated for in vivo detection and quantification of plaque neovascularity. Together with the presence of a large lipid-rich core, thin fibrous cap, positive remodeling and active inflammatory infiltrate, plaque neovascularisation is considered a valid marker of high-risk (or vulnerable) plaque as demonstrated in histopathological studies using microvessel density.

Aim of the study is to assess and validate the value of contrast enhanced ultrasound (CEUS), a bed-side technique, in detecting plaque neovascularisation and compare it with the quantitative assessment by DCE-MRI in carotis atherosclerosis.

A group of 30 patients with asymptomatic carotid atherosclerosis (\> 50% stenosis on Doppler ultrasound) will undergo Carotid Duplex ultrasounds and CEUS. High-resolution plaque MRI and DCE-MRI will be performed in the same patients and will be analyzed by two separate operators blinded to the results of the CEUS in order to detect the efficacy of CEUS when compared with in vivo DCE-MRI, as the standard of reference.


Eligibility Criteria:
Inclusion Criteria:

* Asymptomatic 50-70% carotid artery stenosis on Doppler ultrasound
* Asymptomatic \>70% carotid artery stenosis on Doppler ultrasound (no surgical indication)
* Signed informed consent

Exclusion Criteria:

* Non atherosclerotic occlusive disease
* Prior carotid endarterectomy on the site of the index carotid artery
* Contraindications for MRI and CE MRI (history of hypersensitivity to gadolinium salt, pacemaker or vascular clip implantation, implantation of any metallic device, severe claustrophobic reactions)
* Contraindications to CEUS (hypersensitivity to Sonovue compounds, acute coronary syndromes, acute heart failure, heart failure in NYHA class III or IV, severe arrhythmias, known right-to-left cardiac shunt, severe pulmonary hypertension, uncontrolled arterial hypertension, acute distress respiratory syndrome)
* Short-term life-threatening pathology (life expectancy \< 6 months)
* Physically unable to participate in the study
* Compliance not guaranteed
* Pregnancy
DPBRN Blood Sugar Testing in Dental Patients

The principal goal of this study was to assess the feasibility of plasma glucose testing in private dental practice. A second aim was was to assess prevalence of plasma glucose abnormalities in dental patients seen by (DPBRN) practitioner-investigators.

The specific aims of this study were:

1. To quantify the percentage of (DPBRN) patients who meet the American Diabetes Association screening criteria and to describe the characteristics of these patients.
2. To quantify the acceptability of conducting glucose testing in the dental office and barriers to regular screening, as reported by (DPBRN) patients and practices.

Eligibility Criteria:
Inclusion Criteria:

* adults over the age of 19 who were scheduled for a visit with an exam

Exclusion Criteria:

* patients undergoing continuing treatment where an exam was not part of the visit were not eligible
Combined Alexandrite and Pulsed Dye Laser Treatment of Port Wine Stain Birthmarks

Port wine stain is a congenital, progressive vascular malformation of skin involving post-capillary venules that occurs in an estimated 4 children per 1,000 live births. Approximately 1,200,000 individuals in the United States and twenty-six million people worldwide have Port wine stain birthmarks.

Since most of the malformations occur on the face, Port wine stain is a clinically significant problem in the majority of patients. Port wine stain should not be considered a cosmetic problem but a disease with potentially devastating psychological and physical complications. Personality development is adversely influenced in virtually all patients by the negative reaction of others to a "marked" person. Port wine stain are initially flat red macules, but lesions tend to darken progressively to purple, and by middle age, often become raised as a result of the development of vascular nodules. Hypertrophy of underlying soft tissue further disfigures the facial features of many patients.

The researcher can use alexandrite and pulsed dye lasers pulses combined delivery to improve port wine stain blanching. The alexandrite and pulsed dye lasers are both approved by the Food and Drug Administration for the treatment of Port wine stain. However, the degree of port wine stain blanching seen following either alexandrite or pulsed dye lasers treatment remains variable and unpredictable. Treatment of port wine stains can use either alexandrite or pulsed dye alone and with the combined delivery of alexandrite and pulsed dye lasers pulses.

Eligibility Criteria:
Inclusion Criteria:

* Port Wine Stain suitable for comparison testing
* Age \> 12 years and older
* minor will be accompanied by parents or guardians during laser treatment
* Apparent good health as documented by medical history

Exclusion Criteria:

* History of photodermatoses or skin cancer
* Any therapy within the previous two months to the proposed Port Wine Stain treatment sites
* Current participation in any other investigational drug or device evaluation
* Concurrent use of known photosensitizing drugs
Palliative Care During Intraperitoneal Chemotherapy in Patients With Ovarian Cancer

RATIONALE: Palliative care may help improve the quality of life of patients with ovarian cancer who are undergoing intraperitoneal chemotherapy.

PURPOSE: This clinical trial is studying palliative care in patients with ovarian cancer who are undergoing intraperitoneal chemotherapy.

OBJECTIVES:

* Describe symptoms/concerns before, during, and after intraperitoneal (IP) chemotherapy and the impact of these symptoms/concerns on the quality of life (QOL) of patients with ovarian cancer undergoing IP chemotherapy. (Part I)
* Analyze care received and resource utilization of these patients, including length of hospitalization, ICU admission rates, clinic visits, phone calls, urgent care visits, and other heath system encounters. (Part I)
* Develop palliative care assessment measures and interventions that apply to IP chemotherapy. (Part II)
* Implement a palliative care intervention in a pilot of 6 patients. (Part II)
* Describe the impact of implementing palliative care interventions on resource utilization, improved QOL and symptoms, and number of chemotherapy courses completed. (Part II)

OUTLINE: This is a two-part study.

* Part I (retrospective portion): Patients who have undergone intraperitoneal (IP) chemotherapy within the past 6-12 months undergo a retrospective interview and chart audit to identify their needs and experiences.
* Part I (prospective portion): Patients are followed monthly for up to 6 months during IP chemotherapy to provide information about usual care and to identify needs and palliative care concerns. Patients also complete a quality-of-life (QOL) questionnaire (COH QOL Ovarian tool) and undergo a prospective interview.
* Part II (intervention): Patients undergo comprehensive palliative care assessment, a patient teaching session prior to the initiation of IP chemotherapy, and a palliative care intervention during IP chemotherapy. Patients also complete a QOL questionnaire and undergo an interview. Patients are followed monthly for up to 6 months during IP chemotherapy.

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Diagnosis of ovarian cancer
* Under the care of the Medical Oncology Department at the City of Hope National Medical Center
* Undergoing intraperitoneal chemotherapy

PATIENT CHARACTERISTICS:

* Life expectancy \> 6 months
* Speaks English or Spanish

PRIOR CONCURRENT THERAPY:

* See Disease Characteristics
Closing the Loop in Young Children With Type 1 Diabetes

The incidence of type 1 diabetes (T1D) is increasing worldwide with evidence of most rapid increase in preschool children. Intensive control of blood glucose levels, although essential to protect against onset and progression of diabetes-related complications, faces unique challenges in toddlers and preschool children. A closed-loop system can enhance accuracy of insulin delivery and help people with T1D attain a tight glucose control avoiding the risk of hypoglycaemia. The main components of the system are a continuous glucose monitor (CGM), an insulin pump and a computer-based 'model predictive algorithm', which calculates the amount of insulin to be given by the insulin pump according to the CGM values. In the studies performed thus far the efficacy and safety of closed-loop glucose control were evaluated in children and adolescents aged 6 to 18 years. The results showed that closed-loop improved control of blood glucose and prevented nocturnal hypoglycaemia, as compared to the conventional insulin pump therapy. The objective of the current study is to extend the evaluation of closed-loop further to younger children aged 2 to 6 years, who may gain a great benefit from this novel therapy. The present study adopts an open-label, randomised, 2 period cross-over design whereby closed-loop insulin therapy using diluted insulin (20IU/ml)will be compared with closed-loop with standard insulin (100IU/ml)in 12 young children with T1D. Participants aged 2 to 6 years will be randomised for two overnight studies in a clinical research facility, during which glucose levels will be controlled by either the computer-based closed-loop algorithm using diluted insulin or by closed-loop with standard insulin. On both occasions, participants will receive a self-selected evening meal and closed-loop will run from 17:00 until 08:00am the following day. The study will take place at the Wellcome Trust Clinical Research Facility, Cambridge with participants recruited from paediatric diabetes clinics in England.


Eligibility Criteria:
Inclusion Criteria:

* The subject is between 2 and 6 years of age (inclusive)
* The subject has had type 1 diabetes, as defined by WHO criteria for at least 6 months
* The subject will be an insulin pump user and carers will have a good knowledge of insulin dose adjustment
* HbA1c below 12 % (108mmol/mol)

Exclusion Criteria:

* Non-type 1 diabetes mellitus including those secondary to chronic disease
* Any other physical or psychological disease likely to interfere with the normal conduct of the study and interpretation of the study results
* Current treatment with drugs known to interfere with glucose metabolism such as systemic corticosteroids
* Known or suspected allergy against insulin
Multiple Gestation Study

The objectives of the clinical study are to demonstrate the accuracy of our new NATUS diagnostic method to determine the genetic health of the developing fetuses in a multiple gestation pregnancy from a maternal blood sample. The long term goal of this study will be the development of a method of minimally invasive prenatal diagnosis that has a higher sensitivity and lower false positive rate in the intended population (e.g. multiple gestation pregnancies) than any currently available screening tests. This will result in fewer unnecessary amniocenteses and CVS procedures, which are associated with a risk of miscarriage.


Eligibility Criteria:
Inclusion Criteria:

* Age 18 or older at enrollment
* Clinically confirmed multiple gestation pregnancy
* Gestational age between ≥ 9 weeks, 0 days and ≤26 weeks 0 days by best obstetrical estimate
* Able to provide informed consent

Exclusion Criteria:

* Women carrying singleton pregnancy
* Surrogate or egg donor used
A Comparison of Short Interval vs. Routine Postpartum Visit on Contraceptive Initiation

The current postpartum care model of a single visit 4-6 weeks after delivery does not optimally address contraceptive needs. By this visit, many women have resumed sexual activity, potentially putting them at risk for unintended and rapid repeat pregnancy. In addition, many women with pregnancy-related Medicaid lose insurance coverage at this time, making it difficult to obtain long-acting reversible contraception (LARC) if desired. Therefore, an earlier postpartum visit may remove barriers to improve access to LARC thereby, reducing unintended and rapid repeat pregnancy. Our primary objective is to determine whether an additional 3-week postpartum visit, compared to usual postpartum care, will affect the initiation of LARC by 6 weeks postpartum.

Our primary objective is to determine whether an additional 3-week postpartum visit, compared to usual postpartum care, will affect the initiation of LARC by 6 weeks postpartum. Our secondary outcomes include: 1) desired method of postpartum contraception; 2) continuation and satisfaction with contraception; and 3) incidence of rapid repeat and unintended pregnancy at 12 months. We will also measure attendance and satisfaction with 3- compared to 6-week postpartum visits.We will perform a two-arm randomized controlled trial (RCT). Women will be randomized to routine postpartum follow-up compared to two postpartum visits; one at 3 weeks and one at 6 weeks, with initiation of contraception at the 3-week visit as indicated. Women will be recruited from the postpartum service of Barnes-Jewish Hospital and all women will receive structured comprehensive counseling (adapted from the CHOICE Project Model) prior to discharge from the hospital. Postpartum visits will occur at our outpatient ambulatory clinic sites. Participants will complete in-person surveys at baseline and at each visit, and telephone surveys at 6- and 12-months postpartum. Planned recruitment will be 200 women based on a 2-fold increase in LARC initiation in the intervention group compared to control group (40% vs. 20% initiation rate).

Eligibility Criteria:
Inclusion Criteria:

* Delivered at Barnes-Jewish Hospital
* Receiving postpartum care at resident clinic

Exclusion Criteria:

* Received LARC, sterilization, or hysterectomy
* Abortion, stillbirth, or neonatal death
* Non-English speaking
* Unable to comply with follow-up
Tissue Growth Characterization for Cochlear Implant Users

It is known from post-mortem histological studies that a significant portion of individuals who undergo cochlear implantation (CI) have scar tissue form around the implanted electrode array over time. This scar tissue affects the electrical performance of the cochlear implant, affecting how the implant stimulates the auditory nerve. It is possible that if this scar tissue was detected, the implant programming could be adjusted to account for the changing tissue properties. As part of another study, a computational modeling approach for patient-customized simulation of cochlear implant stimulation is being developed. The simulation approach uses as input CT images and electrophysiological measurements from the cochlear implant device to simulate stimulation by the cochlear implant. These computational simulation models also provide a way to estimate tissue growth around the array. Tissue growth estimates are optimized in the computational model so that electrophysiological metrics simulated by the model match measurements acquired from the patient's implant. In this study, the aim is to collect data necessary to validate these model predictions.

While the existence of tissue growth around the implanted array is not typically known for most patients, a subset of cochlear implant recipients need to undergo revision surgery when a device failure or poor placement is suspected. For these individuals, the existence of tissue growth around the array in the base of the cochlea can be visualized in the operating room by the surgeon. Individuals will be recruited who are undergoing CI revision surgery at Vanderbilt University Medical Center to participate in this study. In surgery, the presence of scar tissue growth will be evaluated by visual confirmation by the surgeon.


Eligibility Criteria:
Inclusion Criteria:

* Male or female 18 years of age and above undergoing revision cochlear implant surgery.

Exclusion Criteria:

* Age \< 18 years or not undergoing revision cochlear implant surgery.