linjc16/ctgov huggingface dataset:
Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Study Overview
=================
Brief Summary
-----------------
Gastroesophageal reflux disease (GERD) is a common condition affecting more than 100 million adults in the U.S., and it significantly impacts patients' quality of life while imposing billions of dollars of direct and indirect costs each year upon our healthcare system. Current diagnostic tests for GERD are highly invasive and medically inadequate, and the goal of this project is to develop a novel, minimally invasive Mucosal Impedance technique for more accurate detection of GERD while reducing costs.

Official Title
-----------------
Assessment of Esophageal Epithelium Integrity With Mucosal Impedance

Conditions
-----------------
Gastroesophageal Reflux Disease (GERD), Non-erosive Reflux Disease (NERD)

Intervention / Treatment
-----------------
* Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing standard of care EGD with 48-hr pH testing by BRAVO Previous diagnosis of reflux At least 18 years of age Exclusion Criteria: Those less than 18 years of age Unable to give informed consent Use of acid suppressive therapy within the last 10 days Known history of Barrett's esophagus, gastric surgery, alcoholism, or significant motility condition

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: GERD<br>Those who have abnormal pH and abnormal esophageal mucosa and those who have abnormal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing | Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing<br> <br> |
| Other: non-GERD<br>Those who have normal pH and normal esophageal mucosa and are scheduled for standard of care esophagogastroduodenoscopy (EGD) with mucosal impedance testing | Procedure: Standard of Care esophagogastroduodenoscopy (EGD) with mucosal impedance testing<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of lower esophageal impedance using mucosal impedance catheter | Mucosal impedance is obtained during routine care EGD and readings are compared to 48-hour Bravo capsule results. Mucosal impedance only takes one minute to perform during endoscopy. | During standard of care EGD | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
reflux, GERD, EGD, pH testing
Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix

Study Overview
=================
Brief Summary
-----------------
-list item one, The purpose of this study is to evaluate the overall response rate of belotecan (CKD-602) in recurrent or progressive carcinoma of uterine cervix

Detailed Description
-----------------
list item one, to evaluate toxicities of Belotecan list item two, to evaluate duration of primary response for responding patients list item three, to evaluate time to disease progression list item four, to evaluate progression free survival and overall survival.

Official Title
-----------------
A Phase II Study of Belotecan (CKD-602) in Recurrent or Progressive Carcinoma of Uterine Cervix

Conditions
-----------------
Cervical Cancer

Intervention / Treatment
-----------------
* Drug: Belotecan(CKD-602)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed, patients with recurrent uterine cervical carcinoma who were unsuitable candidates for curative treatment with surgery and/or radiotherapy. One of the following histologic types Squamous cell carcinoma Adenocarcinoma Adenosquamous carcinoma Clinically measurable disease Performance status of 0, 1, 2 on the ECOG criteria Exclusion Criteria: Histology of neuroendocrine tumors Patient previously treated with topoisomerase-I inhibitor

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CKD-602<br> | Drug: Belotecan(CKD-602)<br>* Belotecan was administrated at 0.5 mg/m(2)/day for 5 consecutive days every 3-week cycle<br>* Other names: Camptobel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| overall response rate of belotecan (CKD-602) |  | 1 week before the start of Cycle 4, 3 weeks later Cycle 6 or at discontinuation of study treatment, and then at least every 3 months |
Knee Aspiration and High Definition MRI for ACL Injury

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to understand the biological changes that occur within the knee joint following injury to the anterior cruciate ligament (ACL). This will be achieved through aspiration and analysis of the haemarthrosis which fills the knee following injury. The study will look at inflammatory and healing responses using DNA, RNA and protein analysis. This, combined with high resolution imaging of the knee and surrounding soft tissue structures, may enable a more patient specific approach to treatment of ACL injury.

Official Title
-----------------
Pilot Study Into the Structural Local Molecular Environment Following an ACL Injury

Conditions
-----------------
ACL Injury

Intervention / Treatment
-----------------
* Diagnostic Test: Aspiration of haemarthrosis and high definition MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of ACL injury confirmed by MRI All participants must have the capacity to provide informed consent to participate Participants must be able to comply with required study visit Exclusion Criteria: Participants outside of the specified age range Participants who do not have the mental capacity to make informed decisions Participants who have meniscal pathology or other injuries requiring urgent surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Aspiration of haemarthrosis and high definition MRI|Aspiration of haemarthrosis and high definition MRI|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pattern of injury on High Definition MRI measured by comparison with 3t MRI images | Outcome will illustrate any additional benefit of high definition MRI | Last visit, usually 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identification of acute inflammatory mediators measured by NanoString molecular analysis |  | Last visit, usually 28 days |
A Prediction Model of 28-day Mortality in Septic Shock

Study Overview
=================
Brief Summary
-----------------
This clinical study adopts the design of cohort research, selects the sepsis shock patients admitted to our hospital ICU as the research object, takes the 28-day mortality rate as the outcome index, collects the baseline data of the patient, the severity of the disease, vital signs, the main infection site, the laboratory-related index, the treatment method and other data, screens out the risk factors affecting the sepsis shock 28-day mortality rate and constructs the prediction model accordingly, analyzes the prediction model with the subject's working characteristic curve (ROC). The recognition ability of the model is calculated by the area under the ROC curve (AUC) and the ability of the model to predict 28-day mortality with SOFA and APACHE II.

Official Title
-----------------
A Prediction Model of 28-day Mortality in Septic Shock

Conditions
-----------------
Septic Shock

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years of age, gender-neutral; Diagnosed with sepsis shock; ICU survives longer than 48 h; The preservation of clinical data is complete; Exclusion Criteria: - Diagnosed with sepsis shock within 6 hours of emergency treatment; Combined with people with autoimmune diseases; 3. Organ transplantation or immunosuppressive treatment; 4. Severe heart, liver and kidney insufficiency; 5. Late stage of malignant tumor; 6. Maternity; 7. Referral or referral to another hospital;

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 |
| --- | --- |
| Death group<br>Retrospective observational studies | |
| Survival group<br>Retrospective observational studies | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All causes of 28 days mortality | The all-cause mortality rate is measured from the time the ICU is admitted to the hospital and 28 days after admission (regardless of ICU, hospitalization or out-of-hospital mortality). | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU hospitalization time | hospitalization time | 2 years | 
| hospitalization mortality |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mortality, Predictive model
DISCO - Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP)

Study Overview
=================
Brief Summary
-----------------
To assess the impact of standardized written information on outcome in acute LBP.

Detailed Description
-----------------
A 3-month prospective, controlled study with a quasi-experimental design (i.e., a nonrandomized controlled sample with geographic stratification [30 areas]). Control and intervention areas ARE selected for their similarities in rural-to-urban distribution of the population and patients' access to GPs and to minimize risk of overlap between areas.

Official Title
-----------------
Influence of a Simple Information Booklet on the Evolution of Acute Low Back Pain (LBP): a Quasi-experimental Study in a Primary Care Setting.

Conditions
-----------------
Acute Low Back Pain

Intervention / Treatment
-----------------
* Other: Patients' questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Each GP have to enroll up to 4 patients with acute LBP. Exclusion Criteria: Patients are excluded if they are less than 18 years old; have pain for more than 4 weeks; have pain intensity for the previous 24 hours less than 3 on a 11-point numeric scale (0= no pain, 10=maximal pain); have sciatica; have had a previous episode of acute LBP during the last 12 months; have no occupational activities; have consulted another practitioner for the same episode of back pain; are pregnant; have back pain related to infection, tumor, or inflammatory disease; or (j) have previously undergone back surgery. The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

| Intervention/Treatment |
| --- |
|Other: Patients' questionnaire|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Pneumonia

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the clinical efficacy of amoxicillin given twice or three times a day to children with non-severe community-acquired pneumonia.

Official Title
-----------------
Clinical Efficacy of Amoxicillin Given Twice or Three Times a Day Among Children With Non-severe Community-acquired Pneumonia

Conditions
-----------------
Community-acquired Pneumonia

Intervention / Treatment
-----------------
* Drug: Amoxicillin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children aged between 2 and 59 months Report of respiratory complaints Presence of pulmonary infiltrate on chest x-ray taken on admission and read by the pediatrician on duty Exclusion Criteria: lower chest indrawing danger signs (inability to drink, convulsions, somnolence, central cyanosis, grunting in a calm child) diagnosed underlying chronic diseases (anatomic abnormalities of the respiratory tract, chronic pulmonary illness besides asthma, immunological defects, progressing neurological disorders, psychomotor retardation, heart disease with clinical repercussion, hemoglobinopathy, liver or kidney disease) severe malnutrition other concurrent infection hospitalization during the previous 7 days amoxicillin or similar antibiotic use during the last 48 hours allergy to amoxicillin history of aspiration

Ages Eligible for Study
-----------------
Minimum Age: 2 Months
Maximum Age: 59 Months

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Amoxicillin given twice a day<br> | Drug: Amoxicillin<br>* amoxicillin 50mg/kg/day given in two different administration schemes<br>* Other names: Placebo with amoxicillin,in the opposite posologic scheme;|
| Active Comparator: Amoxicillin given three times a day<br> | Drug: Amoxicillin<br>* amoxicillin 50mg/kg/day given in two different administration schemes<br>* Other names: Placebo with amoxicillin,in the opposite posologic scheme;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical efficacy | resolution of fever, difficulty breathing and tachypnea | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution of cough | Disappearance of cough | 96 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children aged under 5 years, Non-severe
Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

Study Overview
=================
Brief Summary
-----------------
Premature infants stand a risk of danger to the layer of the eye that creates sight that, if untreated, can cause severe vision problems, leading to blindness in some cases. This research study will use ultrasound to examine the eye for retinal changes of prematurity.

Detailed Description
-----------------
Retinopathy of prematurity requires the early detection of retinopathy in neonates with a gestational age of < 28 weeks and a birth weight <1500 g. These evaluations require pupillary dilation, diagnostic expertise, consume much time and expense and are not without morbidity. B-scan ultrasonography using a hand-held probe is part of the current ophthalmologist's armamentarium, providing a non-invasive view of the eye and avoiding the morbidity associated with mydriatic drops used for pupillary dilation. We will use a simple water bath enclosure for a standard 20 MHz probe currently in general ophthalmic use to determine whether this simple technique might supplant indirect ophthalmoscopy as a screening technique. We will compare, using masked observers, the clinical findings of indirect ophthalmoscopy of neonatal infants with ultrasonic findings to determine if a correlation in the stages of retinopathy of prematurity (ROP) between the two techniques existed.

Official Title
-----------------
Ultrasound to Detect Evidence for Retinal Detachment in Retinopathy of Prematurity

Conditions
-----------------
Retinopathy of Prematurity

Intervention / Treatment
-----------------
* Procedure: Ultrasound examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: premature birth Exclusion Criteria: none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Ultrasound examination|contact ultrasound examination|

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Retinopathy of Prematurity, Ultrasound, Eye
Function of Implanted Glucose Sensor 2

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to verify safety and assess tolerance of a long-term, implanted glucose monitoring sensor. The study will also provide data to characterize the response properties and calibration of the implanted sensor and determine if such properties vary with implant duration.

Official Title
-----------------
Function of Implanted Glucose Sensor 2

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Model 100 Sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Either: (1) male or (2) female and not pregnant, breastfeeding, or planning to become pregnant Diabetes diagnosis of type 1, or type 2 using insulin Under the routine care of a physician for diabetes treatment Able to understand and follow directions History of compliance with diabetes care regimen Able to comply with study requirements regarding planned clinical visits and exams In good physical condition without major medical concerns or blood chemistry abnormalities Exclusion Criteria: Mental disorders that might affect compliance to protocols Diabetes diagnosis type 2 where treatment involves (1) oral medication without insulin or (2) insulin use restricted to a single daily injection of long-acting insulin or (3) control by diet/exercise regimen alone History of intolerance or sensitivity to any of the device materials History of any adverse reaction or allergy to any of the drugs/agents utilized in the study procedures History of recurrent skin infections

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Study Group<br>Device: Model 100 Sensor | Device: Model 100 Sensor<br>* One Model 100 Sensor to be implanted per subject.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Adverse Events | Incidence of adverse events related to the Intervention | From enrollment to 2-weeks post-explant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diabetes mellitus requiring insulin
Intravenous Insulin in Patients With Diabetes After Percutaneous Coronary Intervention (PCI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effects of intravenous insulin/24 hours to normalize glycemia upon markers of oxidative stress (protein oxidation and total antioxidant defense) and inflammation (C-reactive protein (CRP) and sCD40L) in diabetic patients submitted to PCI with stent.

Official Title
-----------------
Intravenous Insulin for 24 Hours in Patients With Diabetes Mellitus Submitted to Percutaneous Coronary Intervention With Stent: Effects Upon Oxidative Stress and Inflammatory Markers

Conditions
-----------------
Diabetes Mellitus, Percutaneous Coronary Intervention

Intervention / Treatment
-----------------
* Drug: Intravenous Insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Diabetes Mellitus submitted to Percutaneous Coronary Intervention with Stent bare metal Age: 18-80 years old Exclusion Criteria: Restenosis Drug elution stent Acute coronary syndrome at last 30 days Use anti inflammatory, antibiotic, vitamin E Inflammatory disease or oncologic

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard treatment<br>glycemia before meals and subcutaneous regular insulin if higher than 200 mg/dl | |
| Other: Intravenous Insulin<br>intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl | Drug: Intravenous Insulin<br>* continuous intravenous insulin/24h guided by glycemia (Optium, Abbott) evaluated hourly, targeting values lower than 110 mg/dl<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reintervention, Myocardial Infarction, Cardiovascular Death |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with Diabetes Mellitus Submitted to Percutaneous Coronary Intervention with Stent