cyrilzakka/clinical-trials huggingface dataset:
Instrument Utility for Suspected Asthma (0000-042)(COMPLETED)

This research study was designed to help improve the diagnosis and treatment of asthma in young children. An interventional strategy using a scoring system based on risk factors and symptoms/episodes was tested to determine its ability to identify children likely to benefit from induction of asthma controller therapy at an early age. The score was derived through completion of a survey instrument referred to as the asthma risk questionnaire (ARQ). The utility of the ARQ along with the health care utilization and use of controller therapy for respiratory illnesses within one year were examined.


Eligibility Criteria:
Inclusion Criteria:

* Children less than or equal to 6 years of age who had at least 1 year prior episode of wheezing

Exclusion Criteria:

* Children with other systemic or chronic respiratory disease and children who used an asthma controller medication with the 6 weeks prior to enrollment
Determinants of Acquired Endocrine Resistance in Metastatic Breast Cancer: A Pilot Study

This is a single-center prospective study involving analysis of circulating tumor DNA (ctDNA) and the gut microbiome in patients with metastatic breast cancer on standard of care endocrine therapy with an aromatase inhibitor in combination with an inhibitor of the cyclin-dependent kinases 4 and 6 (CDK 4/6). Up to 20 patients with Estrogen Receptor positive (ER+), Human Epidermal Growth Factor Receptor 2 negative (HER2-) metastatic breast cancer and Eastern Cooperative Oncology Group (ECOG) performance status 0-1 will be enrolled. This study involves the collection and analysis of patient samples and does not involve therapeutic intervention.

Endocrine therapies have been associated with an overall survival benefit in breast cancer and are the preferred initial treatment approach in patients with ER+, HER2- metastatic breast cancer. Unfortunately, resistance to endocrine therapies eventually develops in the metastatic setting and metastatic breast cancer remains an incurable disease. Endocrine resistance may develop as a result of alterations in estrogen signaling and metabolism pathways, which may be modulated by gut bacteria. In addition, genomic profiling of archival tissues and circulating tumor DNA (ctDNA) in ER+ breast cancer has identified multiple somatic molecular alterations that may mediate response to endocrine therapies.

This study is designed to identify markers of endocrine resistance in ctDNA and the gut microbiome in patients with ER+ HER2- metastatic breast cancer.

Eligibility Criteria:
Inclusion Criteria:

* Sign written and voluntary informed consent
* Histological confirmation of advanced ER positive and HER2 negative breast cancer.
* Adult patients at least 18 years of age
* ECOG performance status equal to 0 or 1
* Able to provide written informed consent
* Must be willing to provide blood for ctDNA analysis on study enrollment and at specified study time points
* Must be willing and able to perform stool sample collection
* Patients must be suitable, as per their treating physician, for initiation of first line endocrine therapy with an aromatase inhibitor and a CDK 4/6 inhibitor for metastatic disease

Exclusion Criteria:

* Prior treatment with CDK 4/6 inhibitors in the neoadjuvant or adjuvant setting
* Use of targeted therapies other than endocrine therapies alone in the neoadjuvant or adjuvant setting
* Relapse on prior endocrine therapy or within 6 months of discontinuation of prior adjuvant endocrine therapy
* History of inflammatory bowel disease, chronic diarrhea or malabsorption syndromes and significant prior bowel resection as judged by the study investigator
* Use of immunosuppressants including steroids within the previous 4 weeks of planned Cycle 1 Day 1 treatment
Impact of Liposomal Bupivacaine Administered Following Placement of a Transobturator Suburethral Sling

Liposomal bupivacaine or placebo will be administered at the end of a transobturator midurethral sling to determine if there is a difference in a patient's perceived postoperative pain.

The investigators aim to evaluate the use of liposomal bupivacaine to reduce postoperative pain from placement of transobturator slings for the treatment of stress urinary incontinence.

Eligibility Criteria:
Inclusion Criteria:

* Adults \> 18 years of age
* Planning for outpatient surgical treatment of SUI with placement of a transobturator suburethral sling under general anesthesia

Exclusion Criteria:

* Pregnant or nursing
* Allergy to bupivacaine
* History of drug/alcohol abuse
* Severe cardiovascular, hepatic, renal disease, or neurological impairment°
* Long-acting opioid within 3 days or any opioid use within 24 hours before surgery
* Contraindication to:
* acetaminophen
* oxycodone
* non-steroidal anti-inflammatory drugs (NSAID)
* Administration of an investigational drug within 30 days before study
* Chronic pain syndromes
* Daily NSAID/opioid use
* Patients having concomitant procedures or not undergoing general anesthesia
* Patients who require a concomitant anterior repair or urethrocele repair will not be excluded as this requires the same dissection in the anterior vaginal wall.
Improving Assessment (and Ultimately Outcomes) of Permanent Prostate Implant Therapy

Permanent prostate implants are a type of radiation therapy in which a high dose of radiation is delivered to cancerous tissue by many small radioactive "seeds". Studies of early-stage prostate cancer patients treated in this way and followed for 10 - 12 years indicate a cure rate of about 80%. This result is similar to surgery and other forms of radiotherapy, but comes with fewer side effects and greater convenience for the patient. Further studies show that the radiation dose delivered is the most important factor in achieving a cure. At present this dose is estimated by a computer, using a computed tomography (CT) scan of the patient and a simple calculation method. The dose estimate is not as accurate as it could be, however, because the precise extent of the prostate is hard to determine from the CT scan, and the calculation method does not make use of information about patient body tissues. The researchers propose to eliminate these inaccuracies by using magnetic resonance imaging (MRI) to identify the prostate gland and by developing an improved dose calculation algorithm that includes information about patient tissues. This new approach will allow physicians to assess implant quality with greater certainty, improve their implant technique, and ultimately increase the cure rate to as much as 95%.

This study addresses three major sources of post-implant dosimetry inaccuracy for permanent prostate implants: post-operative edema, prostate contour delineation, and dose calculation method. It is hypothesized that a pragmatic edema model can minimize the first uncertainty, co-registered CT + MR images the second, and an improved dose calculation algorithm the third.

Detailed objectives are to:

* measure and model the effects of edema on dosimetry;
* evaluate CT + MR image registration methods;
* compare dosimetry for CT alone vs. CT + MRI using the contemporary TG-43 dose calculation method;
* set up a Monte Carlo code that makes full use of the information in CT + MR images to perform implant dose calculations;
* compare prostate dosimetry for the Monte Carlo vs. the simpler TG-43 method;
* develop an analytical post-implant dose calculation algorithm for routine clinical use (Monte Carlo is too slow on a single-CPU brachytherapy planning computer); and finally
* assess the performance of the new algorithm.

Of the estimated 250,000 new cases of prostate cancer in North America in 2004, most are early stage disease as a consequence of PSA testing. Permanent prostate implant therapy is a major option for this group, as long-term clinical studies indicate a cure rate equal to surgery and external beam radiotherapy, but with fewer complications. By dealing with dosimetric inaccuracies, a proven treatment can reach its full potential.

Eligibility Criteria:
Inclusion Criteria:

* Candidate for permanent prostate implant

Exclusion Criteria:

* Not ambulatory
Assessment of New Enhanced Ostomy Device in Real-life Settings in Subjects Having a Stoma

The study investigates the performance of a new adhesive with regard to the skin condition


Eligibility Criteria:
Inclusion Criteria:

* Have given written informed consent
* Have an ileostomy or a colostomy with liquid\* output (as their usual output)
* Be at least 18 years of age and have full legal capacity
* Have had their stoma for at least three months
* Be able to use products with max cut size 45 mm
* Have self-reported problems with leakage\*\* (three times within 14 days)
* Handle the Clinical App, test product and comparator product themselves
* Use a flat SenSura® Mio or a flat SenSura® with standard adhesive as their current product
* Minimum change of baseplate at least once every 3rd day
* Are willing and suitable (determined by investigator/study nurse) to use the test product and comparator without using a paste/mouldable ring during the investigation
* Are willing and suitable (determined by investigator/study nurse) to use a 1-piece product during the investigation

Exclusion Criteria:

* Are currently receiving or have within the past two months received radio-and/or chemotherapy (low doses chemotherapy are allowed for other indications than cancer, e.g. below 15 mg methotrexate for rheumatoid arthritis)
* Are currently receiving or have within the past month received topical steroid treatment in the peristomal skin area (e.g. lotion or spray) or systemic treatment\* (e.g. injection or tablets).
* Get a positive result of a pregnancy test for women of childbearing age/fertile (\*\*clarified in section 6.3.2)
* Are breast feeding
* Are participating in other interventional clinical investigations or have previously participated in this investigation

Exception:

Participation in other Coloplast in-house clinical investigations is accepted under the circumstances that the subject has paused the activities in the investigation and are otherwise complying with the inclusion and exclusion criteria of this (CP300) protocol.

- Have known hypersensitivity towards any of the products used in the investigation
Cyproterone Acetate in Treating Hot Flashes Following Surgical or Chemical Castration for Prostate Cancer

RATIONALE: Cyproterone acetate may be effective treatment for hot flashes following surgical or chemical castration for prostate cancer. It is not yet known which regimen of cyproterone acetate is more effective for hot flashes.

PURPOSE: Randomized phase III trial to determine the effectiveness of cyproterone acetate in treating patients who have hot flashes following surgical or chemical castration for prostate cancer.

OBJECTIVES:

* Determine the efficacy of cyproterone acetate in patients with hot flashes following bilateral orchiectomy or medical castration for prostate cancer.
* Compare the effectiveness of two doses of cyproterone acetate in these patients.
* Determine the safety of this regimen in these patients.
* Determine the impact of this regimen on the quality of life of these patients.

OUTLINE: This is a randomized, double-blind, placebo controlled study.

Patients receive one of two doses of oral cyproterone acetate or placebo for 12 weeks, followed by a 6-9 month open label extension period with all patients receiving cyproterone acetate.

Quality of life is assessed.

PROJECTED ACCRUAL: Not specified

Eligibility Criteria:
DISEASE CHARACTERISTICS:

* Prostate cancer patients who have undergone bilateral orchiectomy or medical castration (LHRH agonist drugs) and are experiencing hot flashes
* Hot flashes are defined as:

  * At least 3 to 4 moderate to severe hot flashes per day or 21 per week at baseline
  * Present at least 1 month prior to study

PATIENT CHARACTERISTICS:

Age:

* 18 and over

Performance status:

* ECOG 0-1

Life expectancy:

* Greater than 12 months

Hematopoietic:

* WBC at least 3,000/uL
* Platelet count at least 75,000/uL
* Hemoglobin at least 6.2 mmol/L

Hepatic:

* Bilirubin no greater than 1.8 mg/dL
* SGPT no greater than 96 u/L
* SGOT no greater than 90 u/L
* LDH no greater than 600

Renal:

* BUN no greater than 42 mg/dL
* Creatinine no greater than 3.39 mg/dL

Cardiovascular:

* No cardiovascular risks (e.g., history of angina pectoris) unless controlled by medical or surgical therapy
* No known history of thromboembolic disease

Other:

* Comprehend and understand English language
* No other prior malignancy within the past 5 years except treated squamous or basal cell skin cancer or superficial bladder carcinoma

PRIOR CONCURRENT THERAPY:

Biologic therapy:

* Not specified

Chemotherapy:

* At least a 4 week washout period is required if prior antineoplastic or cytotoxic chemotherapy has been used

Endocrine therapy:

* At least a 4 week washout period is required if prior estrogens, antiandrogens (e.g., flutamide or bicalutamide), progestational agents, or corticosteroids have been used
* No concurrent herbal medications with known hormonal ingredients (i.e., phytoestrogens)

Radiotherapy:

* Not specified

Surgery:

* See Disease Characteristics

Other:

* At least a 4 week washout period is required if prior clonidine or monoamine oxidase inhibitors have been used
Safety of Iodinated Contrast in Liver Transplant Candidates With Decreased Renal Function Undergoing Coronary CT Angiography

This study evaluates the safety of iodinated contrast medium administered to liver transplant candidates with decreased renal function undergoing coronary CT angiography. Incidence of post-contrast acute kidney injury in liver transplant candidates with decreased renal function and normal renal function will be compared.

Low osmolar non-ionic contrast medium (LOCM) is routinely used for contrast-enhanced computed tomography (CT) including coronary computed tomography angiography (CCTA).

This study evaluates the effect of LOCM on liver transplant candidates with normal and decreased renal function undergoing CCTA. Incidence of post-contrast acute kidney injury (PC-AKI) will be compared between the two groups before and after contrast medium exposure.

LOCM is a potential cause of PC-AKI, especially in vulnerable population with decreased renal function. According to the American College of Radiology (ACR) manual on contrast media, however, many published studies on PC-AKI in the past have been heavily contaminated by bias and conflation. More recent studies do not confirm a high risk of contrast induced nephropathy.

End stage liver disease patients with normal renal function do not seem to be at a higher risk of developing PC-AKI. Only limited data reporting a low incidence of PC-AKI after contrast-enhanced CT in patients with liver cirrhosis and concomitant decreased renal function exists. Proof of low PC-AKI in this specific population would allow to redirect patients from invasive catheterization to CCTA as their cardiac clearance before transplantation. This study will prospectively investigate the incidence of PC-AKI in this specific at-risk population.

Eligibility Criteria:
Inclusion Criteria:

- Liver transplant candidate, age \> 21 referred for coronary CT angiography, medium-risk patient for coronary artery disease

Exclusion Criteria:

* Liver transplant candidates who are at low-risk for coronary artery disease and therefore do not need coronary CT angiography or invasive catheterization
* Liver transplant candidates who are at high-risk for coronary artery disease and are referred directly to invasive catheterization
* Candidates with chronic kidney disease stage 4, with eGFR \<30 ml/min/1.73m2
* Known or suspected allergy to standard iodine contrast medium
CArdioMetabolism and Atherosclerotic PlaqUe progreSsion

Systematic metabolic diseases are closely related to prevalence and progression of atherosclerosis. This prospective cohort consecutively enrolls patients with coronary artery disease compliacted with metabolic abnormalities such as diabtetes, prediabetes, obesity, chronic kidney disease and hyperuricemia.

CArdioMetabolism and Atherosclerotic PlaqUe progreSsion (CAMPUS) study is a single center, prospective cohort study to investigate the impact of cardiometabolic factors on coronary diseases. This study consecutively enrolls patients with coronary artery diseases complicatied with metabolic abnormalities, including diabetes, prediabetes, obesity, chronic kidney disease and hyperuricemia.

Eligibility Criteria:
Inclusion Criteria:

* Age 18-80 years
* Established coronary artery disease or metabolic disorders, including:

  1. Type 2 diabetes diagnosed by one of the following criteria:

     HbA1c \>/= 6.5% Fasting plasma glucose \>/= 7.0 mmol/l (confirmed) 2h plasma glucose value during OGTT \>/= 11.1 mmol/l Already receiving glucose-lowering agents
  2. Prediabetes
  3. Obesity
  4. Chronic kidney disease
  5. Hyperuricemia
  6. Dyslipidemia

Exclusion Criteria:

* Severe liver failure (Child-Pugh grade B to C)
* Severe anemia (hemoglobin \< 60g/L)
* Familial hypercholesterolemia
* Active malignant tumor
* Active autoimmune diseases on corticosteroids
* Acute or chronic infection
* Life expectancy \< 1 year
Echocardiographic Assessment of Cardiovascular Changes in Long Term Space Flight

The National Space Biomedical Research Institute is interested in learning more about heart function in space. One potential problem with long duration, manned space flight is muscle loss- including loss of heart muscle. One goal of our research is to help identify why this muscle loss occurs. We are interested in patients undergoing aortic valve surgery because this procedure is performed to correct a problem with the valve that may also change heart function. This change in heart function may provide information that is useful in understanding and potentially preventing the loss of cardiac muscle in space.

Three patient groups will be studied, patients having surgery for aortic regurgitation, aortic stenosis, and coronary bypass. We are planing to perform this study on 30 patients, 10 in each group.

The aim of this study is to continue our ongoing study of the magnitude and predictors of the changes in size of the left ventricle following acute volume and pressure unloading as a ground-based analog for manned space flight.

Among the most serious of the risks identified by NASA in the area of cardiovascular alterations are serious dysrhythmias and the development of orthostatic intolerance. Prolonged exposure to microgravity may lead to a reduction in cardiac performance, particularly during times of stress and that undiagnosed cardiovascular disease may manifest during long missions. The PI and colleagues have worked closely with NASA and NSBRI over the last six years to optimize use of ultrasound in the space program as an investigative modality, addressing fundamental cardiovascular problems in need of countermeasures development. We propose the following specific aim:

To continue our ongoing study of the magnitude and predictors of LV mass regression following acute volume and pressure unloading as a ground-based analog for manned spaceflight. This work will continue to focus on patients undergoing aortic valve surgery, but exploit recent knowledge of the roles of cytokines and integrins involved in cardiac hypertrophy and regression as well as emerging technologies such as gene chip analysis.

This work will be closely focused on risks and critical questions identified by the Cardiovascular Alterations Team as described in the Bioastronautics Critical Path Road Map Baseline Document. If successful, this project will enhance assessment of cardiac function during long duration missions and potentially suggest cytokine promoters or signal transduction pathways that could be targeted for cardiac atrophy countermeasures. In addition, we will continue to provide the facilities of our Core laboratory for access by investigators throughout the NASA and NSBRI programs in need of assistance in acquiring or analyzing ultrasonic data.

Eligibility Criteria:
Inclusion Criteria:

* \> 18 years of age
* Isolated severe aortic stenosis
* Preserved left ventricular function
* CABG patients will have normal LV function and mass
Immune Dysfunction in Newborn Sepsis

The aim of the project is to study neonatal immune dysfunction associated to the risk of newborn sepsis in a malaria endemic area in Benin.

The fetal immunological responses maturate gradually during the last 3 months of pregnancy. To respond to pathogens, newborns depend essentially on their innate immune system. Premature babies have a significant impairment of innate and immune regulatory functions, thus promoting neonatal sepsis. In addition, chronic infections during pregnancy, including those of parasitic origin, fetal immunity. In utero exposure to P. falciparum antigens impacts particularly the newborn immune development and is a risk factor predisposing to malaria and also to other infections during the first year of life.

The major objectives are to assess:

* The relevance of a host biomarker driven diagnostic of sepsis in newborns,
* The relevance of immune markers as indicators of sepsis incidence, secondary infections occurrence, and mortality
* The role of novel diagnostic techniques (FilmArray panels) as part of the microbiological diagnostic,
* The immunological profile of the infants in the 3 first months of life.

The targeted population is newborns with a high risk to develop sepsis recruited at delivery compared to a control infant population with a low infection risk.

Eligibility Criteria:
Inclusion Criteria for the sepsis risk group (400 infants):

* Child born from mothers having one of the following criteria before delivery will be included in this study:

  * Spontaneous preterm delivery (\<37 weeks of gestation time)
  * Foul smelling / with meconium / colored / bloody amniotic liquid
  * Rupture of membranes \> 18 hours
  * Maternal fever at delivery
  * Vaginal infection
* Child born at the maternity of CNHU (Centre National Hospitalier et Universitaire, Cotonou, Benin) or CHUMEL (Centre Hospitalier et Universitaire de la Mère et de l'Enfant Lagune, Cotonou, Benin) or HZAC (Hopital de zone d' Abomey-Calavi, Benin).
* Mother located near Abomey-Calavi. This criterion has been included to limit the follow-up expenses and spare the travel to the project staff in charge of the 3 month follow-up.

Inclusion Criteria for the control group (170 infants):

- Child born from mothers enrolled in the RECIPAL study (Pregnancy-associated malaria and Intrauterine growth restriction in Benin)

Exclusion Criteria for both groups:

* HIV + status or unknown HIV status of the mother (as the mother and child will be part of the national program to take care of mother and child HIV+ at delivery)
* Parents do not consent to be included in the study.
Intraperitoneal Dexamethasone, Dexmedetomidine, and Dexamethasone-Dexmedetomidine Combination on Postoperative Nausea and Vomiting After Laparoscopic Cholecystectomy

Nausea and vomiting are some of the most common complaints of patients after any anesthesia, which is often associated with postop-erative pain. The double-blind clinical trial study aimed to compare the prophylactic effect of dexamethasone and dexmedetomidine and their combination in reducing postoperative nausea and vomiting in patients undergoing laparoscopic cholecystectomy.


Eligibility Criteria:
Inclusion Criteria:

* Patients aged from 20 - 50 years
* ASA I OR II
* undergo laparoscopic cholecystectomy

Exclusion Criteria:

* Patients with history of psychotic illnesses,
* Parkinson's disease
* motion disorder
* Smoker
* or history of chemotherapy