cyrilzakka/clinical-trials huggingface dataset:
Efficacy of Adding Budesonide to Poractant Alfa to Prevent Bronchopulmonary Dysplasia.

This study evaluates the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia in preterm infants with respiratory distress syndrome. Half of the participants will receive budesonide and poractant alfa in combination, and the other half will receive poractant alfa with saline.

A randomized double bind controlled trial, designed to evaluate the addition of budesonide to poractant alfa to prevent bronchopulmonary dysplasia (BPD) in preterm infants with respiratory distress syndrome (RDS).

The usual treatment of RDS includes ventilatory support and exogenous surfactant, however, a cronic lung disease known as BPD, is a complication found in many of these patients.

BPD is a complex disease occurring in preterm infants recovering from RDS and inflammation plays a key role in its physiopathology.

Animal derived surfactants have demonstrated to decrease the incidence of BPD, and porcine surfactant (poractant alfa) has and increased effect compared with bovine surfactant (beractant).

Budesonide is an inhaled anti-inflammatory steroid that has shown to reduce BPD when combined with beractant by decreasing lung inflammation, without secondary systemic effects, when combined with poractant alfa it could enhance even more this anti-inflammatory effect.

Eligibility Criteria:
Inclusion Criteria:

* Birth weight \<1500g
* Gestational age ≥ 26 weeks
* Respiratory distress syndrome that requires exogenous surfactant at birth or in the first 12 hours of life.

Exclusion Criteria:

* Major congenital anomalies.
* Perinatal asphyxia
* Respiratory depression secondary to general anesthesia.
Serum Caspase 3, Annexin a2 and Soluble Fas Levels and Endometriosis

The study population will comprise of 90 women age varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of \>4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility. The blood samples will be drawn for analysis of serum biomarkers.

The participants will be accepted for the study between 1st of August 2016 to 30th June 2017. 2 cc blood samples will be drawn from the antecubital vein for serum analysis of caspase 3, annexin a2 and soluble fas levels before the operations. The patients will divide into three groups. The group 1 will comprise of 30 patients with benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination. The group 2 will comprise of 30 patients with diagnosis of stage 1-2 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. The group 3 will comprise of 30 patients with diagnosis of stage 3-4 endometriosis in guidance with the revised American Society for Reproductive Medicine classification. The blood samples will be kept in -80 C degree after centrifuge till at the end of the study.The relation between serum caspase 3, annexin a2 and soluble fas levels and severity of endometriosis will be analysed.

Eligibility Criteria:
Inclusion Criteria:

* The women ages varying between 15-55 years, those are candidate for laparoscopic surgery due to definition of \>4 cm endometrioma or any other benign ovarian cysts such as mature teratoma or simple serous cysts on ultrasound examination, chronic pelvic pain, infertility.

Exclusion Criteria:

* The women with malignant diseases, chronic bowel disease, other defined cause of infertility.
PET/CT Scan as a Tool to Rationalize the Treatment of of Advanced NSCLC Patients Undergoing First Chemotherapy

The purpose of this study is to test whether an early metabolic response, measured by PET/CT scan after the first cycle of chemotherapy, is able to predict which patients with advanced NSCLC have a better prognosis.


Eligibility Criteria:
Inclusion Criteria:

* Diagnosis of cytologically or histologically confirmed non-small cell lung cancer.
* Metastatic (stage IV, both M1A or M1B) or locally advanced (stage IIIB, with metastasis to supraclavicular nodes) according to TNM VII edition.
* Both patients at first diagnosis or those with disease recurrence after initial surgery are eligible.
* At least one target or non-target lesion according to RECIST revised version 1.1.
* Age \> or = 18 years .
* ECOG PS 0-2.
* Life expectancy \> 3 months.
* Signed informed consent.

Exclusion Criteria:

* Uncontrolled diabetes (glucose \> 200 mg/dl
* EGFR mutation, for those patients who have had testing done. (EGFR test is not required for participation in the study, but may be conducted as part of normal clinical practice, and patients with EGFR mutation would not be candidate for first-line chemotherapy.)
* Any other malignancies within 5 years (except for adequately treated carcinoma in situ of the cervix or basal or squamous cell skin cancer or surgically resected prostate cancer with normal PSA).
* Pregnant or lactating females.
* Previous medical therapy for metastatic disease (prior surgery, radiation therapy are permitted, as well as adjuvant medical therapy completed at least 6 months prior to study entry).
* Any poorly controlled illness (including active infections, significant hepatic, renal, metabolic or cardiac disease, myocardial infarction within previous 12 months) that may, according to physician's judgement, interfere with the patient's ability to undergo chemotherapy and/or the examinations within the study protocol
* Inability to provide informed consent.
Measurements of CSF Shunts and Off-Shunt Locations with Wireless Thermal Anisotropy Measurement Devices

This study collects data using non-invasive devices for assessing CSF shunt flow using thermal anisotropy measurements in a prospective study setting. The study will collect data to compare measurements from flowing shunts, non-flowing shunts, and off-shunt locations.


Eligibility Criteria:
Inclusion criteria:

1. At least one existing ventricular CSF shunt, functional or non-functional (including an adjustable valve set to "virtual off," ligated shunt, uncorrected distal catheter disconnection or fracture, distal catheter fragment left in place during shunt surgery, or indication that the shunt is otherwise non-functional), with a region of overlying intact skin appropriate in size for application of the study device
2. If more than one distal shunt catheter is present, at least one distal shunt catheter is at least 2 cm away from any other distal shunt catheter in the device measurement region
3. Signed informed consent by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
4. Signed medical records release by subject or a parent, legal guardian, health care agent, or surrogate decision maker (according to local statutes)
5. Verbal assent by minors 7 years of age and older who are able to understand the study and communicate their decision

Exclusion criteria:

1. Presence of an interfering open wound or edema in the FlowSense device measurement area
2. Patient-reported history of serious adverse skin reactions to silicone-based adhesives
3. Use of the study device would interfere with standard patient care, or emergency surgery that cannot be delayed, or participation in the study will interfere with, or be detrimental to, administration of optimal healthcare to the subject
4. Participation in any other investigational procedural, pharmaceutical, and/or device study that may influence the collection of valid data under this study
Efficacy Study of Lisdexamfetamine to Treat Binge Eating Disorder

The specific aim of this study is to examine the efficacy and safety of lisdexamfetamine compared with placebo in outpatients with binge eating disorder


Eligibility Criteria:
Inclusion Criteria:

* Patients will meet DSM-IV criteria for BED for at least the last 6 months

Exclusion Criteria:

* Women who are pregnant or lactating and women of childbearing potential who are not taking adequate contraceptive measures. If there is a possibility a female subject might be pregnant, a pregnancy test will be performed. (All women of childbearing potential will have a negative pregnancy test before entering the study.)
* Subjects who are displaying clinically significant suicidality or homicidality.
* A current or recent (within 6 months of the start of study medication) DSM-IV diagnosis of substance abuse or dependence
The Diagnostic Value of FAPI PET/CT in Staging of Newly Diagnosed Prostate Cancer

This study aims to investigate the diagnostic value of FAPI PET/CT, relative to standard-of-care imaging using PSMA PET/CT, in staging of newly diagnosed PCa. FAPI PET/CT will be visually and quantitatively correlated to PSMA PET/CT resulting in detection rates and target-to-background ratios. If available, histopathology of resected specimens will serve as reference test for operated patients in order to determine diagnostic accuracy. All outcomes are descriptive and serve as pilot for a potential subsequent larger prospective diagnostic study.


Eligibility Criteria:
Inclusion Criteria:

* Male, aged ≥ 18 years;
* WHO performance status 0, 1 or 2;
* Written informed consent;
* Biopsy-proven newly diagnosed PCa;
* International Society of Urological Pathology (ISUP) grade group (GG) ≥ 3 and/or PSA ≥ 20 ng/ml and/or ≥cT3a.

If all of the criteria above are met, a subject must also meet all of the following subgroup specific criteria:

Group 1 (n=15):

- PSMA PET/CT with PSMA-avid primary tumor with PSMA-avid loco-regional and/or distant metastases.

Group 2 (n=15):

* PSMA PET/CT with PSMA-avid primary tumor with no PSMA-avid loco-regional or distant metastases;
* Increased risk of nodal metastases according to the Briganti 2019 nomogram (Briganti ≥40%) \[22\];
* Scheduled for (laparoscopic) prostatectomy including ePLND.

Exclusion Criteria:

* Known second malignant disease that may complicate image interpretation.
* Inability to cooperate with the scan process: inability to lie relatively still and in supine for 30-60 minutes or patient body habitus above scanner dimensions.
Electroretinography: Investigation of a Protocol Change

The study evaluates whether an eye test called an electroretinogram (ERG) can be shortened and still produce the same diagnostic results. The results of this study may allow test times to be reduced which will have benefits such as improved patient compliance during shorter testing and increased clinic efficiency.

A full-field electroretinogram (ERG) is a standardised eye test undertaken in specialist hospital clinics. ERGs are useful for diagnosing and monitoring retinal diseases. The retina is stimulated by showing patients flashes of light and the resulting electrical response from the eye is recorded using delicate electrodes that touch the surface of the eye. For the first section of the test, patient's eyes are allowed to adjust to the dark to ensure the parts of the retina responsible for seeing in dimly-lit conditions are being tested.

The international ERG Standard says patients must sit in the dark for 20 minutes. The investigators have evidence to suggest the test may be equally useful after only 10 minutes in the dark. The investigators plan to compare ERGs recorded from patients who have spent only 10 minutes in the dark with ERGs recorded from the same patients after the full 20 minutes in the dark. If the difference is suitably small, as found in a preliminary study of healthy individuals, it could be justifiable to shorten the routine patient protocol.

Subjects for this study will be recruited from the adult population routinely attending for an outpatient ERG test. During their routine ERG test, 10 minutes into the 20 minute wait in the dark, the investigators propose recording an additional, identical set of ERG tests. This will not add extra time to the clinical test.

Participants will not need any follow-up for the research study. The study requires 262 patients to test the hypothesis, and the investigators estimate this will take about 5-6 months.

Eligibility Criteria:
Inclusion Criteria:

* Patients referred to the adult visual electrophysiology service regardless of clinical condition, and who require dark-adapted electroretinography as part of their appointment
* Male or female
* All ethnicities

Exclusion Criteria:

* Patients less than 18 years old
* Patients who might have difficulties understanding the participant information provided (for example, those patients requiring a translator, or who have learning difficulties)
* Patients with photosensitive epilepsy
* Patients appointed for clinical testing urgently, or via telephone, who will not have had an opportunity to receive and review the participant information sheet ahead of the clinical appointment.
Effects on Quality of Life With Zinc Supplementation in Patients With Gastrointestinal Cancer

This randomized study examines how well zinc works in improving quality of life in patients with gastrointestinal cancer that cannot be removed by surgery who are receiving chemotherapy. Zinc may help to improve patient's quality of life by preventing zinc deficiency.

PRIMARY OBJECTIVE:

I. Assess the effects on quality of life (QOL) when supplementing zinc in upper gastrointestinal (GI) cancer patients while they are receiving chemotherapy.

SECONDARY OBJECTIVES:

I. Correlate hypoalbuminemia with serum zinc deficiency.

II. Correlate zinc deficiency with neutropenia.

OUTLINE: Patients are randomized into 1 of 2 groups.

GROUP I: Patients receive zinc orally (PO) thrice daily (TID) for months 1 and 2 only of the first 4 months on therapy.

GROUP II: Patients receive zinc orally (PO) TID for months 3 and 4 only of the first 4 months on therapy.

Eligibility Criteria:
Inclusion Criteria:

* Patients who present to adult medical oncology outpatient clinic with new diagnosis of non-resectable gastric, gastro-esophageal, pancreas or biliary cancer
* Patients plan to receive chemotherapy at an Emory Cancer Center
* No prior chemotherapy or radiation therapy for newly diagnosed gastric, gastro-esophageal, pancreas or biliary cancer
* Patients must sign informed consent

Exclusion Criteria:

* Zinc supplementation is not indicated for pregnant or lactating women therefore, this is an exclusion criteria and women of childbearing age will complete a pregnancy test
Use of Coils During Percutaneous Coronary Intervention

Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes. The study aims to report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.

Background. Use of coils during percutaneous coronary interventions (PCI) is sometimes life-saving and useful althought currently off-label and with unknown clinical outcomes Objectives. To report and compare in-hospital and long-term outcomes of patients undergoing coils implantation for treating coronary perforation or closing coronary aneurysms/fistulas.

Methods. Among 245.652 PCIs performed in 17 high-volume European centers, patients treated with coils will be identified.

The primary outcome was technical success, defined as the successful sealing coronary perforation or aneurysm/fistulas and procedural success defined as technical success without in-hospital Major Cardiovascular Events (MACe). Long-term MACE and mortality were also reported

Eligibility Criteria:
Inclusion Criteria:

* Patients with coronary artery perforation or coronary artery fistula/aneurysm suitable treating with coils embolization

Exclusion Criteria:

* Patients without coronary artery disease suitable of coils treatment
CD71 in Dried Blood Spots in Healthy Males

Understand the effect of recombinant EPO (rEPO) boosting and microdosing on the hematological module of the Athlete Biological Passport (ABP)

* Measure the change in CD71 longitudinally in subjects from both cohorts
* Assess whether rEPO administration can be detected in a dried blood spot (DBS) using recent advances in analytical methodologies
* Compare windows of rEPO detection using both Athlete Biological Passport models and direct detection using analytical methods in urine, blood, and DBS

Despite being banned by the World Anti-Doping Agency, blood doping is a common method of performance enhancement used by athletes wishing to gain an unfair advantage over their competition. A common way to achieve this increase is by using erythropoiesis stimulating agents (ESA's), namely recombinant erythropoietin (rEPO). Though laboratory tests have been developed for the direct detection of all known isoforms of exogenously administered ESAs in both urine and blood, athletes have found ways to circumvent these testing measures using techniques such as microdosing.

Eligibility Criteria:
Inclusion Criteria: Active individuals, preferably those that participate regularly in endurance athletics either for sport or for leisure, between the ages of 18 and 45

- Participants should have ferritin \> 35 ng/mL and transferrin saturation \> 20% at the time of enrollment

Exclusion Criteria: Individuals currently enrolled in a registered testing pool for anti-doping purposes

* Individuals with the intent to compete in sanctioned athletic events during the study period
* Unwillingness to provide urine samples or blood samples
* Not actively exercising
* Individuals who show a high risk for MI/CAD, stroke, CHF, and venous thromboembolism (VTE)., as defined by the Principal Investigator
* Individuals with known drug allergies
* Individuals with EKG abnormalities, as determined by the Principal Investigator
* Individuals who have chronic kidney disease, HIV, cancer, hepatitis B, hepatitis C, or are planning surgery during the study
* Individuals with history of acute or chronic medical or psychiatric condition
* GFR (Creatinine clearance) \<60 mL/min
* Ferritin \>270 ng/mL
* Individuals who have a baseline hemoglobin concentration greater than 15.5 g/dL or a baseline hematocrit above 47%
* Individuals with blood or iron disorders, including polycythemia, hemochromatosis, anemia, or iron-deficiency anemia
* Individuals with a history of bleeding or bone marrow aplasia
* Individuals who are diabetic or with a history of cardiac or hepatic disease or history of drug abuse
Correlation of Urinary Kallikrein With Cytokines, Proteinuria and Renal Function in Chronic Renal Disease Patients

Urinary kallikrein excretion is known to increase in patients with nephrotic syndrome and sick cell disease, but decrease in patients with chronic kidney disease or uremia. Some of authors consider urinary kallikrein is a marker of nephropathy. To evaluate the possible role of kallikrein kinin system in chronic kidney disease, we conduct a retrospective longitudinal observation study. Patients who participating in the "Efficacy of Pentoxifylline on Chronic Kidney Disease" study are included in the study. The morning spot urinary kallikrein and cytokines are measured at the time point of 0 and 12 month in addition to clinical parameters. The correlation of urinary kallikrein and cytokine concentration will be evaluated. Using multiple regression model, the relationship of urinary kallikrein excretion with degree of proteinuria, creatinine clearance and other clinical parameter will also be evaluated.


Eligibility Criteria:
Inclusion Criteria:

* During June 2004 and June 2005 who participate the clinical study "Efficacy of Pentoxifylline on Chronic Kidney Disease" (ClinicalTrials.gov Identifier: NCT00155246)and sign the informed consent.
* Chronic kidney disease history \> 3 months, Serum creatinine: 1.1\~6.0 mg/dl in female. 1.3\~6.2 mg/dl in male.
* Initial Random urine protein (mg/dl) /creatinine (mg/dl) ratio \> 0.5

Exclusion Criteria:

* History of allergy to pentoxifylline;
* females are nursing or pregnant;
* Obstructive uropathy;
* Unable to stop chronic immunosuppressive therapy, NSAID;
* Congestive heart failure (New York Heart Association functional class III or IV);
* Unstable angina, myocardial infarction, coronary artery bypass graft surgery, percutaneous coronary intervention, within the past 6 months prior to signing the informed consent form;
* Cerebral hemorrhage within the past 6 months prior to signing the informed consent form;
* Retinal hemorrhage within the past 6 months prior to signing the informed consent form;
* Known or suspected secondary hypertension (e.g., primary aldosteronism, renovascular hypertension, pheochromocytoma);
* Severe uncontrolled hypertension with SBP \> 220 mmHg and/or DBP \> 115 mmHg;
* Hepatic dysfunction as defined by the following laboratory parameters: ALT or AST \> 2 times the upper limit of the normal range;
* Biliary obstructive disorders (e.g. cholestasis);
* Active malignancy
Trauma Patients and Hypothermia in the Emergency Room: ReadyHeat® Versus Cotton Wool Blanket

Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia.

Hypothermia is a common problem in traumatized patients leading to severe complications such as impaired coagulation, increased rate of wound infections and overall patient discomfort among others. Therefore, the investigators test out the new self warming (via an exothermic reaction) ReadyHeat® blanket device against the currently used cotton wool blanket in terms of effects on the prevention and treatment of hypothermia. Near body core temperature is measured by a sublingual sensor as the "gold standard" of body core temperature measurement - the pulmonary artery catheter - is too invasive and not suited for this collective of patients in the emergency room setting. Blanket use will be randomized. Temperature will be taken at emergency room admission, after 15, 30 and 45 minutes of treatment as well as right before handing the patient over to the next caring unit (ICU, IMC, operating theatre etc.). If treatment time is shorter than expected measurement will stop at the latest possible point. Blankets will be applied to the patient once admission in the emergency room is complete and will only be lifted for interventions.

Eligibility Criteria:
Inclusion Criteria:

- Trauma patients ≥ 18 years of all severity stages including poly traumatized patients admissioned through the emergency room

Exclusion Criteria:

* Patients \< 18 years
* Patients after pre-hospital cardiac arrest or ongoing CPR at time of admission