linjc16/ctgov huggingface dataset:
Postoperative TACE(Transhepatic Arterial Chemotherapy And Embolization) for Patients With Hepatocellular Carcinoma

Study Overview
=================
Brief Summary
-----------------
Hepatocellular carcinoma (HCC) is the most common primary malignancy of liver, representing the third leading cause of cancer-related death worldwide. Its overall dismal prognosis is a result of high incidence rates of metastasis and postoperative recurrence, in particular the intrahepatic recurrence. TACE is the most widely used primary treatment for unresectable HCC. It was also used as the optional treatment of relapsed disease. However, the efficacy of TACE used as adjuvant therapy following hepatectomy remains controversial.

Conditions
-----------------
Hepatocellular Carcinoma, Transcatheter Arterial Chemoembolization

Intervention / Treatment
-----------------
* Drug: Transcatheter Arterial Chemoembolization
* Other: No intervention No Transcatheter Arterial Chemoembolization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pathological diagnosis of HCC (AJCC stage I or II) Without recurrence in 1 month postoperation Must be tolerant to TACE Exclusion Criteria: With intrahepatic recurrence postoperation Insufficient liver function Stage III or IV

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TACE<br>Patients after surgery receive Transcatheter Arterial Chemoembolization (TACE) | Drug: Transcatheter Arterial Chemoembolization<br>* Transcatheter Arterial Chemoembolization should be used in the experimental group<br>|
| Active Comparator: Control<br>Patients after surgery do not receive TACE | Other: No intervention No Transcatheter Arterial Chemoembolization<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| DFS(Disease free survival) |  | Time point at when patient was diagnosed recurrence,an expected average of 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TACE, Postoperation
An Assessment of Pulse Pressure Variation to Guide Fluid Therapy in Cardiac Surgery Patients

Study Overview
=================
Brief Summary
-----------------
We aim to test the hypothesis that fluid therapy based on pulse pressure variation (PPV) in patients after cardiac surgery who are mechanically ventilated leads to a significant decrease in the amount of fluid given to such patients in the first 24 hours after surgery

Detailed Description
-----------------
The investigators will study patients after cardiac surgery The investigators will collect data on standard care in pre-intervention population The investigators will collect demographic and clinical data The investigators will collect biochemical data in the first 24 hours after surgery The investigators will collect biochemical, physiological and clinical outcome data The investigators will compare the standard care and intervention period data

Official Title
-----------------
A Before-and-after Assessment of Pulse Pressure Variation Guided Fluid Therapy in Cardiac Surgery Patients Receiving Mandatory Mechanical Ventilation

Conditions
-----------------
Cardiac Surgery

Intervention / Treatment
-----------------
* Other: IV fluid according to PPV
* Other: fluids according to standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: immediately after ICU admission after cardiac surgery mandatory mechanical ventilation - Exclusion Criteria: Pressure support ventilation ECMO Intra-aortic balloon counterpulsation

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PPV<br>use PPV to guide fluid therapy | Other: IV fluid according to PPV<br>* intravenous fluids<br>|
| Placebo Comparator: standard care<br>fluids according to standard care | Other: fluids according to standard care<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean amount of fluid given in the first 24 hours after surgery | all intravenous fluid administered | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physiological outcome | Blood lactate | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, Pulse pressure variation, intravenous fluids
Real-time Comparison of Left Ventricular Strokevolume Measurement by Four Different Methods

Study Overview
=================
Brief Summary
-----------------
Real-time comparison of three different bedside strokevolumemeasurements (arterial waveform analysis, eosofageal doppler and 2D transthoracal ultrasound) validated against cardiac magnetic resonance imaging (CMRI)

Detailed Description
-----------------
20 healthy volounteers between age of 20-40 years, no previous medical history undergo simoultaneous left ventrikular strokevolume measurements using three different methods at rest. After datasampling and without moving, the subject then undergo Cardiac Magnetic Resonance Imaging with 2D-throughplane and cine tecnology for validation of volume measurements. The data is then analyzed using Bland-Altman calculation.

Official Title
-----------------
Real-time Comparison of Left Ventricular Strokevolume Measurement by Four Different Methods

Conditions
-----------------
Difference in Measured Results Using Four Different Strokevolume Measurements Simultaneously.

Intervention / Treatment
-----------------
* Procedure: Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Healthy volounteers age 20-40, BMI < 30, weight < 100 kg, no medications, sinus rythm on ECG, no contra-indications for MRI, ability to give written informed consent. - Exclusion Criteria: Heart and/or vascular disease such as angina pectoris, arrythmias, claudicatio intermittens e g. Diseases in gastrointestinal tract or nose. Coagulopathies Pregnancy Allergys for local anaesthetics Claustrofobia

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 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 |
| --- | --- |
| Healthy volunteers<br>Healthy volounteers with no previous medical history, age between 20-40. Both male and female. Subjects are provided extensive information about the study and the obligations and expectations included. All subjects sign a witnessed informed consent before inclusion. | Procedure: Arterial waveform analysis, esofageal doppler, transthoracal cardiac ultrasound, Cardiac magnetic resonance imaging.<br> <br> * Other names: Vivid S6, GE, Cardiac ultrasound;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Limits of agreement (LOA) is less than 30% using CMRI as validation for each individual measurement of left ventricular stroke volume. |  | Study period (1 month) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Left ventricular stroke volume, Arterial waveform analysis, Esofageal doppler, Ultrasound, Cardiac magnetic Imaging, Limits of agreement
Study For Which Treatment, Tadalafil or Sildenafil, is Preferred For Problems Getting or Maintaining an Erection

Study Overview
=================
Brief Summary
-----------------
To determine if men prefer tadalafil or sildenafil for getting and keeping an erection after treatment with both drugs.

Official Title
-----------------
A Multicenter Open-Label Study to Determine Treatment Preference of Tadalafil (IC351, LY450190) or Sildenafil Citrate in the Oral Treatment of Erectile Dysfunction

Conditions
-----------------
Impotence

Intervention / Treatment
-----------------
* Drug: tadalafil
* Drug: sildenafil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of erection problems Never taken treatments known as PDE5 inhibitors for erection issues Abstain from using any other erection treatments during the study Anticipate a monogamous female sexual relationship Must be able to make required sexual intercourse attempts Exclusion Criteria: History of other primary sexual disorder Treatment with nitrates Have a penile implant or clinically significant penile deformity History of certain heart problems Do not meet certain lab value reference ranges

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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>tadalafil given the first 12 weeks and after a 4 week washout sildenafil is given for 12 weeks. | Drug: tadalafil<br>* 10 mg or 20 mg tadalafil tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)<br>* Other names: IC351;|
| Active Comparator: 2<br>sildenafil given the first 12 weeks and after a 4 week washout tadalafil is given for 12 weeks. | Drug: sildenafil<br>* 25 mg, 50 mg, or 100 mg sildenafil citrate tablets, as needed, no more than once a day, by mouth for 12 weeks (8 week treatment experience phase and a 4 week treatment assessment phase)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference Assessment measured by the Treatment Preference Question |  | 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare efficacies of the two drugs as measured by the Erectile Function domain of IIEF and Questions 2 and 3 of the SEP diary. |  | 0, 12, and 26 weeks | 
| Assess sexual encounters attributes measured by the PAIRS. |  | 0, 12, and 26 weeks | 
| Measure adverse events through the Side Effect Question. |  | 12 and 26 weeks |
HKT-500 in the Treatment of Adult Patients With Ankle Sprain

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to demonstrate the multiple-dose efficacy and safety of HKT-500 for the treatment of ankle sprain.

Detailed Description
-----------------
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain

Official Title
-----------------
A Randomized, Multicenter, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of HKT-500 in the Treatment of Pain Associated With Mild to Moderate Ankle Sprain

Conditions
-----------------
Ankle Sprain

Intervention / Treatment
-----------------
* Drug: Ketoprofen Patch
* Other: Placebo Patch


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: mild to Moderate Ankle Sprain Exclusion Criteria: Any women of childbearing potential who has a positive urine pregnancy test, who is lactating, who is not surgically sterile (by tubal ligation or hysterectomy), who is not at least 2 years postmenopausal, or has not practiced an acceptable form of birth control (defined as the use of an intrauterine device with spermicide, a barrier method with spermicide, condoms with spermicide, subdermal implant, oral contraceptives, or abstinence) for at least 2 months prior to Visit 1.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ketoprofen Patch (HKT-500)<br>Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days | Drug: Ketoprofen Patch<br>* Two Ketoprofen HKT-500 patches applied to target ankle once daily for 14 days<br>* Other names: Topical Patch;|
| Placebo Comparator: Placebo Patch<br>Two placebo patches placed on target ankle once daily for 14 days | Other: Placebo Patch<br>* Two placebo patches placed on target ankle once daily for 14 days<br>* Other names: Sham treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from the baseline of the 100-mm VAS pain intensity score during monopodal weight bearing for 1 second at Visit 3 (Day 3 + 1 day) |  | 3 days + 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the subject's VAS pain intensity during monopodal weight bearing, at rest and in motion, summed pain intensity difference at rest and in motion, cumulative effect of pain reduction |  | 14 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ankle Sprain
Phase 1 Single Dose Escalation Study of CTB-001

Study Overview
=================
Brief Summary
-----------------
A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects

Official Title
-----------------
A Phase 1 Clinical Study, Randomized, Double-blind, Placebo-controlled, Single-dose, Dose Escalation Study of the Safety and Pharmacokinetic/Pharmacodynamic Profiles of CTB-001 Intravenously Administered in Healthy Male Subjects

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

Intervention / Treatment
-----------------
* Drug: CTB-001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 20 to 40 years at screening. Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation. Exclusion Criteria: History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion. History of known hypersensitivity to drugs including CTB-001

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CTB-001 or placebo(mannitol) 0.375mg/kg, single-dose<br> | Drug: CTB-001<br>* IV bolus or IV infusion<br>|
| Experimental: CTB-001 or placebo(mannitol) 0.75mg/kg, single-dose<br> | Drug: CTB-001<br>* IV bolus or IV infusion<br>|
| Experimental: CTB-001 or placebo(mannitol) 1.5mg/kg, single-dose<br> | Drug: CTB-001<br>* IV bolus or IV infusion<br>|
| Experimental: CTB-001 or placebo(mannitol) 0.75mg/kg, and dose escalation<br> | Drug: CTB-001<br>* IV bolus or IV infusion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Summary statistics for SAD parts will be prepared for measured values and changes from baseline values for each dose group. Placebo subjects will serve as the control. Summaries of treatment-emergent and clinically important abnormalities in ECG, physical examination, vital signs, and laboratory (clinical chemistry, hematology, coagulation, urinalysis) data will be provided. The incidence of adverse events(AEs) will be tabulated and compared across dose group in the SAD parts. | Up to 7 hours |
Preoperative Anxiety Evaluation: a New Visual Smileys Scale

Study Overview
=================
Brief Summary
-----------------
Preoperative anxiety is a complex clinical concept with both physiological and psychological consequences.

Detailed Description
-----------------
This study looks at the need for a more user friendly, rapid tool for measuring preoperative anxiety, specifically by evaluating the visual smileys scale.

Official Title
-----------------
Preoperative Anxiety Evaluation: a New Visual Smileys Scale

Conditions
-----------------
Anxiety, Preoperative

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 to 80 years old undergoing surgery at Cedars Sinai Medical Center Exclusion Criteria: did not receive sedative or narcotic prior to the interview

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Preoperative patients<br>Preoperative patients were asked to verbally rate their anxiety 1=on a scale from 0-10 and 2=using the new smiley scale | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anxiety level, as measured by verbal rating scale or visual smileys scale | in preoperative setting | up to 5 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| scale preference | in preoperative setting, comparing verbal rating scale and visual smileys scale | up to 5 minutes | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preoperative anxiety assessment, levels of preoperative anxiety using two different scales
Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1

Study Overview
=================
Brief Summary
-----------------
Gastric bypass (GBP) and laparoscopic adjustable banding (AGB) are common procedures that can result in significant weight loss and significantly improve type 2 diabetes in 40-80% of cases. The mechanism and time course of these changes have not been well studied and are poorly understood. The primary aim of this study is to investigate the potential weight-independent mechanisms of diabetes remission after GBP, by comparing GBP and AGB subjects after similar weight loss.

Detailed Description
-----------------
All participants will be tested before and then after 10 and 20-30% weight loss after either GBP or AGB surgery. Subjects will undergo an oral glucose tolerance test (OGTT) an isoglycemic intravenous glucose test (IVGT) to assess the incretin effect, a measure of insulin sensitivity by an intravenous insulin sensitivity test (IVGTT) and body composition measurements.

Official Title
-----------------
Mechanisms of Diabetes Control After Weight Loss Surgery, Sub-study #1

Conditions
-----------------
Gastric Bypass Surgery, Gastric Banding, Type 2 Diabetes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: obese type 2 diabetes individuals scheduled to undergo bariatric surgery by either gastric banding or gastric bypass surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 60 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 |
| --- | --- |
| gastric bypass<br>Surgical group of obese patients with type 2 diabetes undergoing gastric bypass surgery | |
| gastric banding<br>surgical group of obese patients with type 2 diabetes undergoing gastric banding | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Incretin Effect | Effect of GBP and AGB on incretin hormones glucagon-like peptide-1 (GLP-1) and gastric inhibitory peptide (GIP) | Before surgery, 1, 12, and 24 months post | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Body Composition | Body composition measurements to determine body volume, size, and fat | Before surgery, 12, and 24 months post | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bariatric, Gastric Bypass, Gastric Banding,, Type 2 Diabetes, Incretins, GLP-1, GIP, Insulin secretion, insulin sensitivity