linjc16/ctgov huggingface dataset:
Follow-up Study to Previous CARE Trial

Study Overview
=================
Brief Summary
-----------------
To determine comparative 1-year outcomes in renally impaired patients who previously underwent cardiac angiography with Isovue®-370 or Visipaque™ 320 as part of the IOP-104 trial protocol and were evaluable for determination of post-contrast significant renal injury (defined as >25% increase in SCr or >25% increase in cystatin C).

Official Title
-----------------
CARE (Visipaque 320 and Isovue 370 in Cardiac Angiography in REnally Impaired Patients); FOLLOW-UP STUDY

Conditions
-----------------
Moderate to Severe Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: iodinated contrast agent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (from previous CARE trial) • Screening eGFR between 20 and 59 mL/min/1.73m2 Baseline SCr obtained within 72 hours and before hydration or, if obtained after hydration started, had the screening blood sample obtained within 72 hours of contrast administration At least one post dose blood sample available Received randomized contrast agent Underwent only one cardiac angiography procedure (diagnostic cardiac angiography followed by PCI was considered as one procedure if confirmed by investigator and total duration does not exceed 12 hours), then for this study Provides written Informed Consent and is willing to comply with protocol requirements; Was included in the patient list provided by Bracco; At least 1 year has passed since the patient's participation ended in the original CARE trial, as determined from the list provided by Bracco Exclusion Criteria: • Screening eGFR outside the range of 20 and 59 mL/min/1.73m2 Unstable kidney disease or requiring dialysis upon enrollment Prior to the post-dose blood draw, suffered a critical clinical event that would affect the reliability of serological measurement of renal function Did not receive randomized contrast agent per CARE protocol Did not undergo a cardiac angiography procedure per CARE protocol

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 |
| --- | --- |
| observation<br>patients enrolled in previous trial IOP 104; collecting clinical outcome data on these same patients | Drug: iodinated contrast agent<br>* iodinated contrast agent either 370 stength of iopamidol or 320 strength of visipaque<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Urinary Aquaporin 2 and Expression of the NPHS2 Gene in Adults Suffering From Nephrotic Syndrome

Study Overview
=================
Brief Summary
-----------------
We want to test the hypothesises that patients with nephrotic syndrome have a higher excretion of AQP2 in the urine,that they have a higher concentration of AVP,and a lower C-H2O.Everything will normalize, when the syndrome is in remission.Furthermore we want to test the hypothesis that the expression of mutations in the NPHS2-gene,that codes for podocin,will cause a lack off or a poorer response in the treatment of nephrotic syndrome

Official Title
-----------------
Urinary Aquaporin 2 and Expression of the NPHS2 Gene in Adults Suffering From Nephrotic Syndrome

Conditions
-----------------
Nephrotic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients with nephrotic syndrome in the years 1995 until now; both male and female; the kidney disease must be based upon a kidney biopsy ; age > 18 years - Exclusion Criteria: severe diseases in the heart, lungs or liver; diabetes mellitus; other not well-treated diseases in endocrine organs; cancer unwillingness to participate -

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

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

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

Study Plan
=================
How is the study designed?
-----------------
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
-----------------
AQP-2, NPHS2-gene
Novel Device to Assess Endotracheal Tube Migration

Study Overview
=================
Brief Summary
-----------------
To evaluate the ability of the SonarMed AirWave to provide clinicians with information that enables them to confirm continuous proper placement of the endotracheal tube. This initial study is prospective, observational, looking at CXR results, and comparing those to AirWave system output data.

Official Title
-----------------
Novel Device (AirWave™) to Assess Endotracheal Tube Migration.

Conditions
-----------------
Mechanically Ventilated Patients Admitted to a MICU

Intervention / Treatment
-----------------
* Other: AirWave


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Subjects will be eligible for inclusion in the study if they meet ALL of the following criteria: Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers. Exclusion Criteria Subjects ventilated through a tracheostomy Subjects under 18 years of age

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 |
| --- | --- |
| Oral or nasal endotracheal intubation<br>Oral or nasal endotracheal intubation, anticipated to last at least 48 hours Adults that require ETT internal diameter sizes of 6.5 - 9.0 mm Subject must be at least 18 years old (no upper age limitation) English speaking patients/decision makers. | Other: AirWave<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endotracheal tube displacement measured by a novel device (AirWave) | Use of the AirWave in the study group to calculate ETT tip distance from the carina will demonstrate a strong positive correlation with chest x-rays results. Specific endpoints will include: • Compare CXR tube tip movement/distance to carina measurement results to AirWave tube tip movement/distance to carina calculation results (from the AirWave baseline location) within 24 hours after intubation. | within 24 hours after intubation. |
Trial of Chinese Prescription Shugan Decoction on Irritable Bowel Syndrome（Diarrhea Type）

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy and safety of the Chinese prescription Shugan decoction on irritable bowel syndrome（diarrhea type）.

Conditions
-----------------
Irritable Bowel Syndrome, Traditional Chinese Medicine

Intervention / Treatment
-----------------
* Drug: Shugan decoction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of irritable bowel syndrome（diarrhea type） Male of female patients between 18-65 years old Written informed consent Exclusion Criteria: Discrepancy of irritable bowel syndrome Diarrhea-type of irritable bowel syndrome combine with intestinal disease Combined with severe heart, gallbladder, kidney, endocrine system, hemopoietic system or nervous system disease. Pregnancy or breast feeding women, or unwilling to have contraception.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Shugan Decoction<br> | Drug: Shugan decoction<br>* Decoction ,two times a day,one bag of decoction one time<br>|
| Placebo Comparator: low does of Shugan decoction<br> | Drug: Shugan decoction<br>* Decoction ,two times a day,one bag of decoction one time<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptoms and conditions of tongue and pulse |  | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indicates of liver and renal function |  | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alternative medicine
Durability of Antiviral Activity in Chronic HBV Patients Who Showed Complete Response in L-FMAU-301,302 or 303 Trial

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the durability of antiviral activity in chronic hepatitis B patients who showed complete response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 trial.

Official Title
-----------------
An Open-label, Observation Study to Evaluate the Durability of Antiviral Activity in Chronic Hepatitis B Patients Who Showed Complete Response in L-FMAU-301,L-FMAU-302 or L-FMAU-303 Trial

Conditions
-----------------
Hepatitis B

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patients who have completed L-FMAU-301, L-FMAU-302 or L-FMAU-303. Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL in L-FMAU-301 or L-FMAU-302, in addition, HBeAg seroconverted to anti-HBe at the last two visits in L-FMAU-301) after completion of L-FMAU-301 or L-FMAU-302 and treated with the clevudine. Patients who have showed complete response (ALT normalization and HBV DNA <4,700 copies/mL, in addition HBeAg seroconverted to anti-HBe at the last two visits who showed HBeAg positiv at baseline) after completion of L-FMAU-303 Patients who were able to give written informed consent prior to study start and to comply with the study requirements. Patients with bilirubin levels less than 2.0 mg/dL, prothrombin time of less than 1.7 (INR), and a serum albumin level of at least 3.5 g/dL at the last visit in L-FMAU-301, L-FMAU-302 or L-FMAU-303. Exclusion Criteria: Patients who have showed complete response but previously treated with placebo in the L-FMAU-301, L-FMAU-302. Patients who were currently receiving antiviral, immunomodulatory or corticosteroid therapy. Patients previously treated with interferon, lamivudine, lobucavir, famciclovir, adefovir or any other investigational nucleoside for HBV infection. Patients with a history of ascites, variceal hemorrhage or hepatic encephalopathy. Patients co-infected with HCV, HDV or HIV. Patients with a liver mass (hemangioma, nodule), biliary diseases except asymptomatic GB stone during the L-FMAU-301, L-FMAU-302 or L-FMAU-303. Patients who were pregnant or breast-feeding. Patients with a significant gastrointestinal, renal, hepatic (decompensated), biliary diseases except asymptomatic GB stone, bronchopulmonary, neurological, cardiovascular, oncologic or allergic disease. The patients with a benign tumor were excluded if judged by an investigator that the continuation of study would be interfered by benign tumor. Patients who were not suitable to the study if judged by an investigator.
Sexes Eligible for Study
-----------------
All

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Energy Availability in Male and Female Elite Wheelchair Athletes Over Seven Consecutive Training Days

Study Overview
=================
Brief Summary
-----------------
Low energy availability (LEA) is a major problem in sports as athletes ingest often a lower amount of energy compared to their actual needs. The availability of energy is calculated based on their daily energy intake and the energy cost of the daily training sessions in relation to their fat-free mass. Based on this calculation, it is known how much energy will available for the body (beside the fuel for training) to keep it in optimal physiological functioning. It has been shown, that LEA occurs very often in female athletes, in endurance athletes as well as athletes in weight-sensitive sports (i.e. jockeys, combat sports, gymnastics, ballet). The purpose of this study was to investigate, whether LEA is a problem in wheelchair athletes as well.

Detailed Description
-----------------
Energy availability will be assessed over 7 consecutive training days using a dietary and training record as well as the Leisure Time PHysical Activity Questionnaire for spinal cord injury. Resting Energy expenditure will be measured as well as body composition (by a DXA) before the start of data collection.

Official Title
-----------------
Energy Availability in Wheelchair Athletes

Conditions
-----------------
Energy Supply; Deficiency

Intervention / Treatment
-----------------
* Other: evaluating energy availability


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: athletes from a national team in wheelchair sports Exclusion Criteria: unable to follow normal training routine unable to record diet or training

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Male wheelchair athletes<br>Other | Other: evaluating energy availability<br>* energy availability will be determined by measuring energy intake, exercise energy expenditure and fat-free mass and using the following formula: energy availability = (energy intake - exercise energy expenditure) / fat-free mass<br>|
| Female wheelchair athletes<br>Other | Other: evaluating energy availability<br>* energy availability will be determined by measuring energy intake, exercise energy expenditure and fat-free mass and using the following formula: energy availability = (energy intake - exercise energy expenditure) / fat-free mass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| energy availability | energy availability = (energy intake - exercise energy expenditure) / fat-free mass. Energy intake and exercise energy expenditure are measured using a food and training diary. The fat-free mass will be measured using a DXA scan. | 7 consecutive days during pre-season |
Impact of New Interventional Imaging Modality Use on Patient Radiation Exposure in Transarterial Chemoembolization

Study Overview
=================
Brief Summary
-----------------
Transarterial chemoembolization (TACE) is the most performed endovascular interventional radiology (IR) procedure. TACE procedures are performed in an IR suite, most of which are equipped with floor-based flat-panel robotic C-arm allowing two-dimensional imaging. Cone-beam computed tomography (CBCT) has been developed to allow three-dimensional navigation but has several limitations such as reduced signal to noise ratio and small field-of-view, and seems to have negative impact on patient radiation exposure. Another option to perform 3D imaging is called angio-CT which combines a CT-scan and a floor-based flat-panel robotic C-arm in a single IR suite. Even if some publications have shown benefit of angio-CT in TACE procedures in Japan, no study about angio-CT in liver IR procedures has been conducted in the occidental world so far. The purpose of our study was to assess the impact of angio-CT use on patient radiation exposure and treatment quality in TACE procedures compared to CBCT. This before-after study consisted of a review of consecutive TACE procedures performed between January 2016 and September 2017 in our institution with two different imaging modalities, defining two study groups (C-arm with CBCT versus angio-CT).

Official Title
-----------------
Impact of New Interventional Imaging Modality Use (Angio-CT) on Patient Radiation Exposure in Transarterial Chemoembolization

Conditions
-----------------
Hepatic Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Age > or = 18 years primary or secondary liver tumor(s) TACE approved by multidisciplinary tumor meeting Exclusion criteria: - TACE not performed

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 |
| --- | --- | --- |
| Patient effective radiation dose per TACE | Patient effective radiation dose (mSv) per TACE : Dose-area product (in mGy/cm^2) and dose-length product (in mGy/cm) will be combined and converted to report effective dose (in mSv). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Air kerma per TACE | Air kerma (in mGy) per TACE | 1 day | 
| Fluoroscopy time per TACE | Fluoroscopy time (in sec) per TACE | 1 day | 
| Number of CBCT acquisitions per TACE | Number of CBCT acquisitions per TACE | 1 day | 
| Number of CT acquisitions per TACE | Number of CT acquisitions per TACE | 1 day | 
| Treatment targeting | Assessed on control CBCT or CT and graded into 3 classes : fully targeted, partially targeted or untargeted. | 1 day | 
| Tumor response | Assessed on follow-up CT or MRI and graded into 3 classes : response, tumor stability or progression. | 1 day |
ALF-STONE: Alfuzosin in Uretheric Stones

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to assess the effect of Alfuzosin compared with placebo, for 7 days, on the outcome of patients with uretheric stones submitted to Extracorporeal Shock Wave Lithotripsy (ESWL), namely in the percentage of patients without imagiologic evidence of any stone after 72h to 96 hours. This study will also specifically focus on the evaluation of time of stone clearance and of pain reduction (Numeric Rating Scale).

Official Title
-----------------
Alfuzosin in Uretheric Stones

Conditions
-----------------
Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Drug: Alfuzosin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients with imagiologic evidence of uretheric stones Exclusion criteria: Women pregnant or breast feeding Patients with renal impairment (creatinine > 2mg/dl) 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
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Alfuzosin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety: General clinical safety by collection of spontaneously reported adverse events |  | at each visit | 
| Efficacy: Percentage of patients without imagiologic evidence of any stone |  | 72h to 96 hours after ESWL | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients without imagiologic evidence of any stone |  | 24 hours after ESWL | 
| Percentage of patients with clinical evidence of stones clearance |  | 72h to 96 hours after ESWL | 
| Time for stone clearance (clinical evaluation) |  |  | 
| Numeric Rating Scale scores |  | at 24h, (48h, if applicable), 72-96h and 7 days | 
| Need for rescue analgesic medication. |  |  |
Level of Agreement of Intraocular Lens Power Measurements Between IOLMaster and Verion

Study Overview
=================
Brief Summary
-----------------
Primary objective of this study is to evaluate the level of agreement of two keratometry modules, the IOLMaster and the Verion Reference Unit, in terms of keratometric values and IOL power calculation.

Detailed Description
-----------------
Participants were enrolled from the Cataract & Presbyopia Service of the University General Hospital of Alexandroupolis in a consecutive-if-eligible basis. Apart from keratometric values, IOL power calculations will be compared for 8 IOL models (Acrysof SN60WF, SN60AT, SN6ATx, TFNT00, TFNTx0, SV25T0, SV25Tx and Tecnis ZCB00) using 4 formulas (SRK/T, Holladay 1, Hoffer Q and Haigis).

Official Title
-----------------
Level of Agreement of Intraocular Lens Power Measurements Between IOLMaster and Verion

Conditions
-----------------
Cataract

Intervention / Treatment
-----------------
* Diagnostic Test: IOLMaster
* Diagnostic Test: Verion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Senile Cataract Exclusion Criteria: Former incisional surgery, Corneal diseases, Dry-eye-Disease, Glaucoma drops, Inability to obtain accurate measurements.

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 |
| --- | --- |
| IOLMaster group<br>IOL power for all cataract participants will be measured with IOLMaster and Verion | Diagnostic Test: IOLMaster<br>* IOL power calculation will be done with IOLMaster<br>Diagnostic Test: Verion<br>* IOL power calculation will be done with Verion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IOL Power Calculation | Exact calculation of dioptric power of the intraocular lens | 1 day prior to surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cataract surgery, Verion Image-Guided System, IOLMaster, IOL calculation, keratometry, corneal power, toric IOL