linjc16/ctgov huggingface dataset:
Fusion Imaging Contrast-enhanced Ultrasound LI-RADS

Study Overview
=================
Brief Summary
-----------------
CEUS LI-RASD apply to lesion visible at precontrast ultrasound but not the lesion invisible. Fusion imaging can use to invisible lesions at precontrast ultrasound in clinical practice. Thus, our aim is to explore the application value of CEUS LI-RADS in contrast-enhanced fusion imaging for focal liver lesions that are not visible on conventional ultrasound in high-risk patients with hepatocellular carcinoma.

Official Title
-----------------
Fusion Imaging Contrast-enhanced Ultrasound LI-RADS in Patients With High-risk Hepatocellular Carcinoma With Focal Liver Lesions Invisible on Conventional Ultrasound: a Multi-center Prospective Study

Conditions
-----------------
Hepatocellular Carcinoma

Intervention / Treatment
-----------------
* Diagnostic Test: Fusion imaging contrast-enhanced ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at risk for HCC(Cirrhosis or Chronic hepatitis B viral infection or Current or prior HCC) Suspicious lesions detected by CECT/MRI but not visible on conventional ultrasound and US-CECT/MRI fusion imaging Patients sign the informed consent. Exclusion Criteria: Patients without risk of HCC(With cirrhosis due to congenital hepatic fibrosis or With cirrhosis due to a vascular disorder such as hereditary hemorrhagic telangiectasia, Budd-Chiari syndrome, chronic portal vein occlusion, cardiac congestion, or diffuse nodular regenerative hyperplasia) Patients without a successful registration or lesions can be seen on conventional ultrasound after successful registration Pregnancy or lactation Patients with pretreat lesion Patients don't sign the informed consent.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Fusion imaging contrast-enhanced ultrasound LI-RADS<br>Fusion imaging contrast-enhanced ultrasound will be performed in patients with invisible lesion at conventional ultrasound. Drug: SonoVue | Diagnostic Test: Fusion imaging contrast-enhanced ultrasound<br>* Fusion imaging contrast-enhanced ultrasound will be performed for patients with invisible lesion at conventional ultrasound. Drug: SonoVue<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positive predictive value | The positive predictive value = HCC in LR-5 /all lesions in LR-5 | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The sensitivity and specificity of CEUS LR-5 | The sensitivity and specificity are calculated. | 6 months |
Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether breathing pattern (specifically the inspiratory time/total respiratory cycle value) has an influence over the response to the noninvasive mechanical ventilation.

Detailed Description
-----------------
Breathing pattern will be analyzed along the adaptation to 3 different NonInvasive-Mechanical-Ventilation modes (controlled mode, spontaneous mode and placebo mode or simulator).

Official Title
-----------------
Response to NonInvasive Mechanical Ventilation According to the Breathing Pattern

Conditions
-----------------
Neuromuscular Disorders., Chest Wall Disorders., Obesity-hypoventilation Syndrome.

Intervention / Treatment
-----------------
* Device: Spontaneous Ventilation Mode
* Device: Controlled Ventilation Mode
* Device: Simulator Ventilation Mode


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypercapnic chronic respiratory failure due to restrictive pulmonary disease (with usual criteria for home NonInvasive Mechanical Ventilation). Transcutaneous carbon dioxide (CO2) basal pressure ≥ 50 mmHg when conscious. Clinically stable (within the previous month). Patients without previous NonInvasive Mechanical Ventilation treatment. Exclusion Criteria: Clinical exacerbation. Chronic airflow limitation Forced expiratory volume in 1 second/Forced vital capacity (FEV1/FVC) ratio < 70% or Sleep Apnea-Hypopnea Syndrome

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Design Details

Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Spontaneous Ventilation Mode|Respiratory rate and duration of inspiration are controlled by the patient. Device model: Stellar 150® (ResMed, Australia).|
|Device: Controlled Ventilation Mode|Ventilator maintains the positive end-expiratory pressure until the patient inspires. At that point, the ventilator reaches the support pressure in a predetermined time. The patient fixes the respiratory rate and the duration of inspiration, triggering all the cycles. Device model: Stellar 150® (ResMed, Australia).|
|Device: Simulator Ventilation Mode|Ventilator maintains a continuous positive airway pressure during the entire cycle. Device model: Stellar 150® (ResMed, Australia).|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcutaneous carbon dioxide measurement |  | One hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inspiratory-time/total-respiratory-cycle value |  | One hour |
Proof of Concept of an Anaplerotic Study Using Brain Phosphorus Magnetic Resonance Spectroscopy in Huntington Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this project is to study the efficacy of an anaplerotic treatment on brain energy profile evolution at an early stage of the Huntington disease.

Conditions
-----------------
Huntington Disease

Intervention / Treatment
-----------------
* Drug: Triheptanoin 1g/kg/day


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5 < UHDRS < 50 Age > 18 years Ability to undergo MR scanning Covered by french social security Exclusion Criteria: Evidence of psychiatric disorder Attendant neurological disorder Contraindications to MRI (claustrophobia, metallic or material implants) Severe head injury Unable to understand the protocol Pregnancy Failure to give informed consent Subjects with exclusion criteria required by french law (e.g. subjects who require a legally authorized representative to obtain consent) Unwillingness to be informed in case of abnormal MRI

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Triheptanoin 1g/kg/day<br>All patients received Triheptanoin oil at 1g/kg/day during 1 month | Drug: Triheptanoin 1g/kg/day<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of Inorganic Phosphate (Pi) Over Phosphocreatine (PCr): Pi/PCr | The Pi/PCr Ratio is a measure of brain metabolism and it is an index of mitochondrial oxidative regulation. A 6-cm 31P transmit/receive surface coil (RAPID Biomedical GmbH, Rimpar, Germany) was used to collect free induction decays for 4 minutes at rest, 8 minutes during visual activation with 6-Hz red/black checkerboard flashes, and 8 minutes after stimulation. Subjects were able to focus on the flashes with a nonmagnetic mirror mounted above their eyes while all lights in the room were turned off. The Pi/PCr ratio was then calculated to determine brain response to cortical activation. | visit 1 (baseline), visit 2 (after 1 month of treatment) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation Between Primary Outcome Measure and Clinical Parameters | Correlating an improvement of brain energy profile with clinical parameters in Huntington patients such as the Unified Huntington's disease rating scale (UHDRS) and total functional capacity score (TFC). | visit 1 (baseline), visit 2 (after 1 month of treatment) |
Safety Study of AMG 531 in Japanese Subjects With ITP

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.

Detailed Description
-----------------
The purpose of the study is to evaluate the efficacy of starting dose of AMG 531 as measured by platelet counts by cohort dose-escalation design.

Official Title
-----------------
An Open Label Phase 2 Study Evaluating the Safety of Starting Dose of AMG 531 in Thrombocytopenic Japanese Subjects With Immune (Idiopathic) Thrombocytopenic Purpura

Conditions
-----------------
Thrombocytopenia in Subjects With Immune (Idiopathic) Thrombocytopenic Purpura (ITP)

Intervention / Treatment
-----------------
* Drug: Romiplostim (AMG-531)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Japanese patients with diagnosis of ITP according to the diagnostic criteria proposed by Research Committee for Idiopathic Hematopoietic Disorders of the Ministry of health, labor and welfare Exclusion Criteria: - Documented diagnosis of arterial thrombosis in the previous year; history of venous thrombosis and receiving anticoagulation therapy

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: romiplostim (AMG-531)<br> | Drug: Romiplostim (AMG-531)<br>* Romiplostim (AMG-531)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of all adverse events including evaluation of antibody status |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who achieve a platelet response |  | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
AMG 531, ITP, Phase 2, Japanese
Oxidative Stress Markers in Open and Laparoscopic Colectomy for Cancer

Study Overview
=================
Brief Summary
-----------------
Contribution to the study of oxidative stress markers in laparoscopic vs open colectomy for colorectal cancer

Official Title
-----------------
Study of the Oxidative Stress in Patients With Colorectal Cancer. Open vs Laparoscopic Approach

Conditions
-----------------
Colorectal Cancer

Intervention / Treatment
-----------------
* Procedure: Open colectomy
* Procedure: laparoscopic colectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: colorectal cancer Exclusion Criteria: metastases recurrent disease chronic diseases
Sexes Eligible for Study
-----------------
All

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Open group<br>Group of patients operated with open approach for colorectal cancer | Procedure: Open colectomy<br>* Open colectomy. Epidural anaesthesia used<br>|
| Active Comparator: laparoscopic group<br>Group of patients operated with laparoscopic approach for colorectal cancer | Procedure: laparoscopic colectomy<br>* Laparoscopic colectomy. Epidural anaesthesia used<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress markers in patients with colorectal cancer operated with open or laparoscopic approach |  | preoperative, intraoperative, 6h postop, 24h postop | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hsCRP, Lipid peroxidation, Protein peroxidation, DNA peroxidation, RNA peroxidation, Cytokines, Oxidative stress markers, Open surgery, Laparoscopic surgery
Coenzyme Q10 and Vitamin A, C, E in Relation to the Oxidative Stress, Antioxidant Enzyme Activity and Inflammation in Subjects With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Metabolic syndrome (MS) is a significant risk factor of cardiovascular disease. However, the relationships between coenzyme Q10, antioxidant vitamins (Vitamin A, C, E) and the prevention of the risk of MS are still inconsistent. The purposes of this study are going to investigate the relation of coenzyme Q10, antioxidant vitamins concentration with the blood lipid levels, the markers of lipid peroxidation (TBARS), antioxidant enzymes activities (catalase, glutathione peroxidase and superoxide dismutase), and the inflammatory markers (hs-CRP,IL-6 and adiponectin). The investigators will recruit MS patients (case group, n = 100) and age-gender matched healthy subjects from previous study(n = 105) as a control group . The inclusion criteria of MS are according to the Bureau of Health Promotion, Department of Health in Taiwan (2007).Hopefully, the results of this study could provide the information to what has been know in MS subjects. The investigators expect coenzyme Q10 or antioxidant vitamins could be a preventive supplement to reduce the risk of MS.

Conditions
-----------------
Metabolic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Metabolic syndrome Healthy individuals with normal blood biochemical values. Exclusion Criteria: Age < 18y Antioxidant vitamins supplements use Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 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 |
| --- | --- |
| case group<br>Subjects with metabolic syndrome | |
| control group<br>Healthy individuals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Narrow Band Imaging in Flexible Cystocopy

Study Overview
=================
Brief Summary
-----------------
Patients with first time hematuria or patients previously diagnosed with papillomas/CIS of the bladder are included in the study. All surgeons are highly experienced in WL cystoscopy and familiar with NBI findings. Cystoscopy is performed with HD cameras and Olympus light sources. First, a systematic cystoscopy is made in WL. Secondly, the clinical decision is noted. After WL, the cystoscopy is made with NBI and any potential subsequent change in the clinical decision is noted. A total number of 896 patients is planned to be included.

Official Title
-----------------
Narrow Band Imaging in Flexible Cystocopy - DaBlaCa-7

Conditions
-----------------
Narrow Band Imaging in Flexible Cystoscopy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing flexible cystoscopy because of haematuria or previous NMIBC Exclusion Criteria: Patients not fullfilling the above

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 |
| --- | --- | --- |
| change in the clinical decision |  | Baseline |
Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)

Study Overview
=================
Brief Summary
-----------------
Physiotherapist research about Sensory rehabilitation in chemotherapy induced peripheral neuropathy (CIPN) with the aid of questioners and physiotherapy practice

Official Title
-----------------
Sensory Rehabilitation in Chemotherapy Induced Peripheral Neuropathy (CIPN)

Conditions
-----------------
CIPN

Intervention / Treatment
-----------------
* Diagnostic Test: Questionares and practice


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 18 and over who suffer from chemotherapy-induced neuropathy (CIPN), according to the patient's report, more than 3 months since the end of the chemotherapy treatment. Exclusion Criteria: Sensory damage / neuropathy that existed even before the start of chemotherapy Incidents of recurrent falls even before the start of chemotherapy (over 2 falls for 6 months) Tumor involvement of the central nervous system The patient is not mobile even before the start of chemotherapy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 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 |
| --- | --- |
| Patient who suffered from Induced neuropathy Chemotherapy 3 months after end of chemotherapy<br> | Diagnostic Test: Questionares and practice<br>* Questionares and practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| TNAS | TNAS -Treatment-Induced Neuropathy Assessment Scale | 2 years | 
| VAS | 0-100 mm visual scale: self-reporting pain assessment from no pain to worst pain possible. We will ask for current pain and the worst pain during the last week. | 2 years | 
| FABS | Fullerton Advanced Balance Scale: high function balance test - consisting of 10 activities in both static and dynamic phases; 10-40, higher scores are better. | 2 years | 
| TUG | Timed Up and Go: fall prediction screening test; measures time taken to raise from a chair walking 3 meters and re-sit. | 2 years | 
| NSA | Nottingham Sensory Assessment: sensory detection and discrimination test | 2 years | 
| Semmes-Weinstein monofilament testing | tactile detection threshold | 2 years | 
| LEPT | Lower Extremity Position Test: proprioception detection and quantification | 2 years | 
| Allodynia | tested by non-painful mechanical stimulation: gentle brushing and monofilament | 2 years |
A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick

Study Overview
=================
Brief Summary
-----------------
This study will compare blood collection from the forearm using an investigational device TAP20-C to blood collection from the fingertip.

Official Title
-----------------
A Study to Compare Analyte Levels in Blood Samples Collected Using the TAP20-C Device With Results Obtained by Fingerstick

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Fingerstick
* Device: TAP20-C


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subject Group Male and female volunteers 18 years of age or older. Voluntary written consent to participate in this study. Diabetic Subject Group Male and female volunteers 18 years of age or older. Have been diagnosed with Type 1 or Type 2 diabetes mellitus by self-report. Voluntary written consent to participate in this study. Exclusion Criteria: Subjects who are pregnant or nursing mothers by self-report. Subjects with a history of skin disorders or who present with abnormal skin integrity or atypical skin health within the areas to be tested. Subjects with a missing index or middle finger on either hand or a missing forearm Subjects who have known allergies to titanium.

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP20-C<br>TAP20-C | Device: TAP20-C<br> <br> |
| Active Comparator: Fingerstick<br>Fingerstick | Device: Fingerstick<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Inferiority of Analyte Levels | The study will compare the concentrations of various analytes in blood samples collected by both collection methods in a single 2 hour session. | Day 1 |