linjc16/ctgov huggingface dataset:
Observational Study of Oxygen Delivery During a Fractional Fluid Expansion

Study Overview
=================
Brief Summary
-----------------
Fluid expansion during cardiocirculatory insufficiency was helped by cardiac output monitoring. However, the goal of fluid expansion was to increase the oxygen delivery, which consider cardiac output, but also Haemoglobin which decrease during a fluid challenge. The maximalization of cardiac output could decrease the oxygen delivery if the haemodilution was too wide. The aim of this study was to describe the oxygen delivery during a fluid expansion conducted for cardiac output maximalization, following actual guidelines.

Detailed Description
-----------------
One group of 20 anticipated patients

Official Title
-----------------
Observational Study of Oxygen Delivery During a Fractional Fluid Expansion

Conditions
-----------------
Hypovolemia, Impaired Oxygen Delivery, Cardiac Output, Low

Intervention / Treatment
-----------------
* Drug: hydroxyethylstarch 130/0.4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults over 18 years Patients in intensive care after cardiac surgery under mechanically ventilation and with oesophageal Doppler Exclusion Criteria: Arrythmia Pregnancy or childrens Patients without cardiac output monitoring with oesophageal Doppler Patients without medical indication for fluid expansion Urgency surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hypovolemia<br>Fluid expansion | Drug: hydroxyethylstarch 130/0.4<br>* Bolus of 100ml of HES 130/0.4 repeated until maximization of cardiac output<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of oxygen delivery | Retrospective calculation of oxygen delivery (ml.min.m-2)during a fractional fluid expansion every 100ml of hydroxyethyl starch until cardiac output maximalization with oesophageal Doppler and arterial gazes (for PaO2 and Haemoglobin)from arterial line. | only during the fluid challenge | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study of central venous saturation | Central venous gazes after each mini fluid challenge until cardiac output maximalization, from a central line | only during the fluid challenge | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypovolemia, Fluid challenge, Fluid expansion, Oxygene delivery, Cardiac output
PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy

Study Overview
=================
Brief Summary
-----------------
Researchers are trying to determine the side effects on the heart from immune checkpoint inhibitor (ICI) treatment in patients with cancer.

Official Title
-----------------
PET/CT Quantitative Assessment of Myocardial Blood Flow Changes in Oncologic Patients Receiving Checkpoint Inhibitor Therapy

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Diagnostic Test: PET/CT
* Drug: radioactive drug (tracer)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First time administration of ICI Willing and able to return in 4-6 weeks for follow-up study Patients with previous heart conditions included (while this may impact MFR the delta MFR is what we are assessing) Exclusion Criteria: Age < 18 years Women who are pregnant, or breast-feeding. Unable or unwilling to give consent to undergo PET/CT.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Checkpoint Inhibitor (ICI)<br>Subjects diagnosed with cancer and will be receiving immune checkpoint inhibitors as treatment standard of care will have a PET/CT scan before and after therapy. PET/CT scan is done for study purposes only. | Diagnostic Test: PET/CT<br>* Positron emission tomography-computed tomography is an image test that helps show detail about how tissues and organs are functioning.<br>Drug: radioactive drug (tracer)<br>* A radioactive drug (tracer) is used in the PET scan.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular Damage/Endothelial Dysfunction | Number of subjects to develop microvascular damage/endothelial dysfunction as determined by the PET/CT scan. PET-CT MFR used to assess dynamic changes in MFR that occur pre and post initiation of ICI and thereby potentially identify early cardiotoxicity in patients who might be more prone to more devastating IRAEs such as myocarditis. | 6 weeks |
Study to Assess Blood Levels of Itraconazole During a Two-Week Period

Study Overview
=================
Brief Summary
-----------------
The objective of this clinical trial is to document the steady state pharmacokinetics and safety of a new itraconazole 200 mg film coated tablet.

Official Title
-----------------
Assessment of the Steady State Pharmacokinetics of Itraconazole and Hydroxy-Itraconazole in Healthy Subjects After Administration of a New Itraconazole 200 mg Film Coated Tablet Once Daily for Fourteen Days in Fed Condition

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Itraconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 18.0 and 28.0 kg/m2 Good physical and mental health status, determined on the basis of the medical history and a general clinical examination. Vital signs (blood pressure and heart rate) in supine position within the normal range Electrocardiogram (12 lead) considered as normal Non-smoker. Able to swallow pills If subject is a woman of childbearing potential (WOCBP), must agree to use adequate birth control as defined by the protocol Exclusion Criteria: Any disease or physical condition which, in the opinion of the investigator, could impact the pharmacokinetics of the drug History or presence of drug abuse or consumption of alcohol History of sensitivity or allergy to azoles or related drugs Any requirement to be on other drug treatment (except acetaminophen and for WOCBP, hormonal contraceptives) Unsuitable veins for repeated venipuncture. Clinically significant abnormal ECG Nursing mothers and pregnant women, or women of childbearing potential not using adequate contraceptives.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br> | Drug: Itraconazole<br>* Oral<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Steady State Plasma levels of Itraconazole |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy Volunteers
Hepcidin Levels in Preterm Infants

Study Overview
=================
Brief Summary
-----------------
A recently isolated peptide hormone, hepcidin, is thought to be the principal regulator of iron homeostasis. Hepcidin acts by limiting intestinal iron absorption and promoting iron retention in reticuloendothelial cells. The aims of this study were to determine serum hepcidin levels in preterm infants who receive blood transfusion and preterm infants having sepsis, in order to assess possible relationships between hepcidin and serum iron, serum ferritin,in iron load situations.

Official Title
-----------------
Hepcidin Levels in Preterm Infants Receiving Blood Transfusion and During Sepsis.

Conditions
-----------------
Preterm Infants, Anemia of Prematurity, Neonatal Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Preterm < 38 weeks gestation Need of blood test for anemia or suspected sepsis Exclusion Criteria: Major congenital anomalies Birth Asphyxia

Ages Eligible for Study
-----------------
Minimum Age: 24 Weeks
Maximum Age: 37 Weeks

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| preterm infants<br>preterm infants receiving blood transfusion preterm infants with neonatal sepsis. | |

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increase in Hepcidin levels by 30% |  | within 24-72 h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepcidin, Preterm Infants, Anemia, Sepsis, Ferritin
Evaluation of Vaginal Fluid for Covid-19 Positivity in Women With Positive Nasofarengeal Covid-19 Test

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to investigate whether the Covid-19 is found in the vaginal swab samples of female patients diagnosed with covid-19, to evaluate the presence of Covid-19 and the risk of transmission of Covid-19 by intercourse or vaginal delivery.

Detailed Description
-----------------
Vaginal Covid-19 will be tested by taking vaginal swabs from female patients whose clinical findings are compatible with Covid-19 in Acıbadem Maslak Hospital. In patients with positive vaginal Covid-19 test, vaginal Covid-19 will be re-evaluated for the assessment of viral clearance.

Official Title
-----------------
Evaluation of Vaginal Fluid for Covid-19 Positivity

Conditions
-----------------
COVID, Sars-CoV2

Intervention / Treatment
-----------------
* Diagnostic Test: Vaginal fluid Covid-19 PCR test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who are positive nasofarengeal Covid-19 PCR test result Women who are 18 years or older Women who had sexual intercourse before Exclusion Criteria: who had medical treatment for Covid-19

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

Sexes Eligible for Study
-----------------
Female

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Covid-19 positive women<br>Women with nasofarangeal Covid-19 PCR test is positive | Diagnostic Test: Vaginal fluid Covid-19 PCR test<br>* Vaginal fluid samples are tested for Covid-19<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaginal fluid Covid-19 PCR test result | Vaginal fluid Covid-19 test positivity rate for patients whose nasofarengeal test is positive | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| becoming negative from positive | The ratio of negative test results to previous positive results for vaginal fluid Covid-19 test | 2 month |
Prognostic Role of Positron Emission Tomography and Computed Tomography Parameters in Stage I Lung Adenocarcinoma

Study Overview
=================
Brief Summary
-----------------
The clinical and derived data from the preoperative computed axial tomography (CT) and Positron Emission Tomography (PET) of patients with pathological stage I pulmonary adenocarcinoma will be analyzed retrospectively, classified according to the current pathological classification IASLC / ATS / ERS of pulmonary adenocarcinoma, subjected to surgical treatment in our Operating Unit between August 2006 and July 2011. A follow-up will be performed on the patients enrolled in the study up to the date of death, and in any case no later than October 31, 2019

Official Title
-----------------
Prognostic Role of Positron Emission Tomography and Computed Tomography Parameters in Stage I Lung Adenocarcinoma

Conditions
-----------------
Stage I Pulmonary Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients suffering from pulmonary adenocarcinoma in stage I underwent CT, PET and surgical treatment with radical intent, at San Raffale Hospital (thoracic surgery) between August 2006 and July 2011 Exclusion Criteria: primary pulmonary neoplasms other than adenocarcinoma; locally advanced or metastatic disease stage; non-radical resection.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stratification of stage I adenocarcinoma patients, using clinical data derived from preoperative CT and PET | classify patients with pulmonary adenocarcinoma in stage I (retrospective cases) based on the current pathological classification IASLC / ATS / ERS of pulmonary adenocarcinoma using clinical data and derived from preoperative CT and PET | 12 months |
Device Based Therapy in Hypertension Extension Trial

Study Overview
=================
Brief Summary
-----------------
This clinical investigation is designed to describe the long-term safety and efficacy of the CVRx Rheos Baroreflex Hypertension Therapy System in patients who participated in the DEBuT-HT study beyond the original follow up period (4-months or longer). The information obtained in this trial is intended to support regulatory approvals and market release of this therapy.

Detailed Description
-----------------
This extension study, designed as a long-term follow up, will monitor the course of the disease and its treatment safety and efficacy by collecting the appropriate data and using data collected under the long term provisions of the DEBuT-HT study to describe and analyze the changes in ongoing drug treatment, the programming parameters of the implanted active device and any occurring adverse events over a period of up to 13 months after implant surgery in the DEBuT-HT trial. Annual follow-ups of up to five years are planned subsequently to the 13-month follow-up period.

Official Title
-----------------
DEBuT - HET: Device Based Therapy in Hypertension Extension Trial: Long-Term Follow-Up Trial for Patients Who Completed the DEBuT-HT Study

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Device: CVRx Rheos Baroreflex Hypertension Therapy System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed the follow-up period (4-month or longer) of the DEBuT-HT trial (protocol No.: 360004-001) Have signed an approved informed consent form for participation in this study Exclusion Criteria: Are unable to comply with protocol requirements. Are enrolled in another concurrent clinical trial.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CVRx Rheos Baroreflex Hypertension Therapy System|The pulse generator, which is similar to a pacemaker, is typically implanted under the skin below the collarbone. Two small leads from the device are wrapped around the carotid arteries on both sides of the neck and connected to the pulse generator.|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the safety of Rheos Baroreflex Hypertension Therapy System by evaluating all adverse events and estimating the system and procedure related adverse event rate until and including the 13-month follow-up. |  | after last 13-month follow-up | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Refractory Hypertension, High Blood Pressure, Uncontrolled Blood Pressure
Oxygen Saturation Patterns in Post-Op Patients at Risk for Obstructive Sleep Apnea

Study Overview
=================
Brief Summary
-----------------
This study will include patients who have major surgery and are at risk for or have been diagnosed with sleep apnea. The patients will be monitored the night after surgery for repeating episodes of reduced breathing and oxygen levels. The study will determine if episodes of decreased breathing are reflected in the oxygen monitor.

Detailed Description
-----------------
There is no further detailed description available.

Official Title
-----------------
A Prospective Non-Randomized Study of Pulse Oximetry Saturation Patterns in Postoperative Patients at High Risk of Obstructive Sleep Apnea

Conditions
-----------------
Obstructive Sleep Apnea

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients older than 18 years undergoing thoracic, vascular, head and neck, gynecological, urological, general, orthopedic, and plastic surgery. Patient must require analgesia and/or sedation postoperatively by any route (intravenous, intramuscular, oral, epidural or intrathecal) for the duration of the study Postoperative patients with at least one anticipated over night stay on the general ward with a minimum length of 14 hrs. Patients in the ASA category 1-4 Patients at high risk for obstructive sleep apnea (OSA) as identified by the STOP-Bang Questionnaire or patients previously diagnosed with OSA and not using a CPAP device. (No screening with STOP needed for these patients.) Spontaneous breathing Exclusion Criteria: Age less than 18 years Patients receiving or anticipated to receive postoperative positive airway pressure support Previous allergic/contact reactions to adhesives Patients unable to give informed consent Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Repetitive Reductions in Nasal Airflow Patterns in the Pulse Oximetry Saturation Trend Data. | Number of patients exhibiting the presence of repetitive reductions in airflow patterns in the pulse oximetry trend data collected on subjects | 12 hour after released from the recovery room | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship Between the Oxygen Desaturation Patterns and Repetitive Reductions in Nasal Airflow as Measured by Inductance Plethysmography and Nasal Pressure. | The number of patients with a positive repetitive reduction in nasal airflow which correlates with positive oxygen desaturation pattern as measured by photoplethysmography sensors. | 12 hours after discharge form the recovery room |
Genetics of Airway Responsiveness and Lung Function

Study Overview
=================
Brief Summary
-----------------
To perform a genome-wide search for genes affecting two phenotypes related to asthma and chronic obstructive pulmonary disease (COPD) in a Chinese population.

Detailed Description
-----------------
DESIGN NARRATIVE: Airway responsiveness and lung function, endpoints with a strong genetic basis, are central to the obstructive airway diseases (asthma and COPD). In contrast, the dissection of the underlying genes requires unique sample resources, accurate and comprehensive phenotyping, and an efficient study design. To address to this three-pronged challenge, a genomic screen brought together a large, homogenous, mostly untreated sample from Anhui, China, a wealth of expertise in asthma phenotypes, and a potent study design based on extreme discordant sib pairs. Since this approach utilized an extant asthmatic family population, no support for data collection was required. The primary focus of the study was two intermediate phenotypes related to asthma and COPD: airway responsiveness (characterized by increased responsiveness to histamine methacholine or other nonspecific agonists and measured by the slope of the dose response relationship) and forced expiratory volume in 1 second (FEV1). Since both traits are continuous, the appropriate study design considered only siblings with extremely discordant phenotypes. For many studies, this strategy was not feasible due to the thousands of families that must be phenotyped to identify a sample of such siblings. The plan was to utilize the organization of a well-established network in China to collect 150 extreme discordant sib pairs of each intermediate phenotype. For airway responsiveness, the estimated power from this sample, equivalent to roughly 600 concordant sib pairs, was intended to surpass the power of all existing studies, including the U.S. Collaborative Study on the Genetics of Asthma. Further, with similar power, this was the first study to test for linkage to FEV1. Moreover, to further augment power, potential phenotypic heterogeneity was reduced by stratifying the analyses by total and specific serum IgE levels, skin test reactivity, peripheral blood eosinophilia, respiratory symptoms, age, gender, bronchodilator response, and cigarette smoking. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) record.

Conditions
-----------------
Asthma, Lung Diseases, Obstructive, Chronic Obstructive Pulmonary Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

Sexes Eligible for Study
-----------------
Male

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |