linjc16/ctgov huggingface dataset:
Safety & Efficacy Study of Quetiapine Fumarate (SEROQUEL®) vs. Placebo in Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate that (SEROQUEL®) quetiapine sustained-release is efficacious and safe in the treatment of patients with MDD.

Official Title
-----------------
A Multicenter, Double-Blind, Randomized, Parallel-Group, Placebo-Controlled Phase III Study of the Efficacy and Safety of Quetiapine Fumarate Sustained-Release (SEROQUEL®) as Monotherapy in the Treatment of Patients With MDD

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Quetiapine fumarate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient has a documented clinical diagnosis of Major Depressive Disorder. Be able to understand and comply with the requirements of the study. Able to understand and provide written informed consent Exclusion Criteria: Patients (female) must not be pregnant or lactating Current or past diagnosis of stroke or transient ischemic attack (TIA).

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

| Intervention/Treatment |
| --- |
|Drug: Quetiapine fumarate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from randomization to Week 6 in the Montgomery-Åsberg Depression Rating Scale (MADRS) total score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from randomization to each assessment in the MADRS total score |  |  | 
| MADRS response, defined as a ≥50% reduction from randomization in the MADRS total score at Week 6 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MDD, Quetiapine fumarate, sustained release, Depression
Preoperative Portal and Splanchnic Flow Measurement Using MRI

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the alteration of portal and splanchnic flow using MRI after liver transplantation in patients with splenomegaly or splenic varix.

Official Title
-----------------
Preoperative Portal and Splanchnic Flow Measurement in Living Donor Liver Transplantation Recipient With Spontaneous Portosystemic Shunt at MRI: Preliminary Study

Conditions
-----------------
Liver Cirrhoses

Intervention / Treatment
-----------------
* Diagnostic Test: Liver MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: older than 18 years And signed informed consent And planned either a) liver transplantation as a recipient; or b) liver transplantation as a donor Exclusion Criteria: any absolute/relative contraindication of contrast-enhanced 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Liver MRI<br>In this study, MRI refers to phase-contrast 4D flow sequence. | Diagnostic Test: Liver MRI<br>* Liver MRI including 4D flow sequence is performed twice in liver transplantation recipients, before and 1 month-after transplantation. In donor candidates, liver MRI including 4D flow sequence is performed twice in 1-3 weeks to assess repeatability of the technique.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Portal flow | portal flow measured with MRI (4D flow sequence) | in a month after 2nd MRI | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SMV flow | superior mesenteric vein (SMV) flow measured with MRI (4D flow sequence) | in a month after 2nd MRI | 
| Splenic vein flow | splenic vein flow measured with MRI (4D flow sequence) | in a month after 2nd MRI | 
| splenic varix flow | splenic varix flow measured with MRI (4D flow sequence) only in liver recipients | in a month after 2nd MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRI, cirrhosis
Feasibility and Performance Evaluation for INVSENSOR00024

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-randomized, single arm study design to evaluate SpO2 performance of the RD SET Neo investigational pulse oximeter sensors in the neonatal population using convenience sampling in a clinical environment. The initial subjects under Protocol Version 1 were enrolled as part of a feasibility study to verify the design changes to the sensor are correct. The study protocol was amended with Protocol Version 2 to enroll a group of subjects that will be used to evaluate clinical performance for submission to regulatory agencies.

Official Title
-----------------
Feasibility and Performance Evaluation of INVSENSOR00024

Conditions
-----------------
Evaluation of SpO2 Performance

Intervention / Treatment
-----------------
* Device: RD SET Neo SpO2


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Less than or equal to 1 month of age Weight <3kg Subjects admitted with standard of care (SOC) arterial blood sampling line already in place Exclusion Criteria: Subjects with underdeveloped skin Subjects with abnormalities at the planned application sites that would interfere with system measurements Subjects with known allergic reactions to foam/rubber products and adhesive tape Deformities of limbs, absence of feet, sever edema, and other at the discretion of the Principal Investigator

Ages Eligible for Study
-----------------
Maximum Age: 1 Month

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RD SET Neo SpO2<br>All subjects enrolled in the study will receive the investigational sensor (RD SET Neo SpO2) for evaluation of SpO2. | Device: RD SET Neo SpO2<br>* All subjects are enrolled in the experimental group and receive the RD SET Neo SpO2 sensor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of Oxygen Saturation (SpO2) Measurement by RMS Calculation | Accuracy will be determined by comparing the noninvasive blood oxygen saturation measurement of the pulse oximeter to that obtained from a blood sample and calculating the root mean square (RMS) error value. In order to obtain the RMS value, the blood oxygen saturation measurement form a laboratory pulse Co-Oximeter is subtracted from the pulse oximeter oxygen saturation measurement for each sample, the average of this difference is computed as the bias. The standard deviation of the differences is computed as the precision. The square root of the sum of the squares of bias and precision is computed as the RMS Error value. | up to 8 hours |
Assessing the Effects of a Nasal Corticosteroid on PMI-150 (Intranasal Ketamine)

Study Overview
=================
Brief Summary
-----------------
To assess the effects of nasal corticosteroid treatment on the rate and extent of intranasal absorption of PMI-150 (intranasal ketamine HCl)

Detailed Description
-----------------
Subjects will participate in a two-period, single-sequence study to assess the effects of administration of a nasal corticosteroid, Nasonex (mometasone furoate), on the pharmacokinetics, safety and tolerability of PMI-150 (intranasal ketamine HCl) in healthy adult volunteers.

Official Title
-----------------
A Randomized, Open Label Study to Assess the Effects of a Nasal Corticosteroid on the Pharmacokinetics, Safety, and Tolerability of PMI-150 (Intranasal Ketamine Hydrochloride) 30 mg

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

Intervention / Treatment
-----------------
* Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy adults nonsmoker no drug use Exclusion Criteria: nasal abnormalities airway abnormalities

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>PMI-150 (intranasal ketamine HCl), day 1 mometasone furoate, days 2-15 PMI-150 (intranasal ketamine HCl), day 15 | Drug: PMI-150 (intranasal ketamine HCl); mometasone furoate<br>* 1 dose PMI-150 (intranasal ketamine HCl); day 1 mometasone furoate, daily; days 2-15 1 dose PMI-150 (intranasal ketamine HCl); day 15<br>* Other names: Nasonex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic parameters |  | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ketamine, corticosteroid, intranasal, phase I, Healthy volunteers
Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-angle Glaucoma (POAG)

Study Overview
=================
Brief Summary
-----------------
Prospective, unmasked, randomized evaluation of the iStent in patients with primary open-angle glaucoma. Patients will be randomized to one of two groups: 1) iStent, or 2) medication.

Detailed Description
-----------------
Two hundred patients will be enrolled in the study at up to 21 clinical sites; follow-up is through 1 year.

Official Title
-----------------
A Prospective, Unmasked, Randomized Evaluation of the iStent Versus Two Ocular Hypotensive Agents in Patients With Primary Open-Angle Glaucoma

Conditions
-----------------
Eye Diseases, Glaucoma, Open-Angle, Glaucoma

Intervention / Treatment
-----------------
* Device: iStent
* Drug: latanoprost/timolol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of primary open-angle glaucoma Male or female at least 18 years of age and able to provide written informed consent Mean IOP (at baseline visit after washout of any medications) must be 22 mm Hg and no greater than 38 mm Hg Likely to be available and willing to attend follow-up visits Exclusion Criteria: Angle closure glaucoma Secondary glaucomas Prior glaucoma procedures Elevated episcleral venous pressure from history of active thyroid orbitopathy, carotid-cavernous fistula, orbital tumors, or orbital congestive disease

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stent<br>One hundred patients will be randomized to implantation of two G2 stents in at least one eye. | Device: iStent<br>* iStent<br>* Other names: stent, Trabecular micro bypass;|
| Active Comparator: Medication<br>One hundred patients will be randomized to receive a fixed combination ocular hypotensive medication. | Drug: latanoprost/timolol<br>* Combination latanoprost/timolol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intraocular pressure (IOP) |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
primary open angle glaucoma (POAG), OAG, glaucoma
A Study Evaluating the Safety and Clinical Activity of HCV-796 in Treatment-Naive and Non-Responder Subjects

Study Overview
=================
Brief Summary
-----------------
This is a phase 2, randomized, open-label study comparing the safety, antiviral activity, and pharmacokinetics of HCV-796 administered in combination with peginterferon alfa 2B (Peg-Intron) plus concomitant Rebetol vs. Peg-Intron plus Rebetol in Hepatitis C Virus (HCV) genotype 1-infected subjects who are either naive to treatment or who have previously failed treatment (non-responders).

Official Title
-----------------
A Phase 2, Randomized, Open-Label Study Of The Safety, Antiviral Activity, And Pharmacokinetics Of HCV-796 Administered In Combination With Peginterferon Alfa 2B (Peg-Intron) Plus Ribavirin (Rebetol) Versus Peg-Intron Plus Rebetol In Subjects With Hepatitis C Virus Genotype 1 Infection

Conditions
-----------------
Hepatitis C

Intervention / Treatment
-----------------
* Drug: Peg-Intron
* Drug: REBETOL
* Drug: HCV 796
* Drug: Peg-Intron
* Drug: REBETOL
* Drug: HCV 796
* Drug: Peg-Intron
* Drug: REBETOL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Infection with HCV genotype 1. HCV- infected subjects naive to treatment. HCV-infected non-responder subjects. Exclusion Criteria: Women who are pregnant or breastfeeding. ALT >/ or = 5X the upper limit of normal. AST >/ or = 5X the upper limit of normal.

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Peg-Intron<br>* SC injection, weight based dosing, weekly, 48 weeks<br>Drug: REBETOL<br>* Capsules, weight based dosing, Q12 hrs daily, 48weeks<br>|
| Active Comparator: 2<br> | Drug: HCV 796<br>* Capsules, 500 mg, Q 12 hrs. daily, 48 weeks<br>Drug: Peg-Intron<br>* SC injection, weight based dosing, weekly, 48 weeks<br>Drug: REBETOL<br>* Capsules, weight based dosing, Q12 hrs daily, 48weeks<br>|
| Active Comparator: 3<br> | Drug: HCV 796<br>* Capsules, 500 mg, Q 12 hrs. daily, 48 weeks<br>Drug: Peg-Intron<br>* SC injection, weight based dosing, weekly, 48 weeks<br>Drug: REBETOL<br>* Capsules, weight based dosing, Q12 hrs daily, 48weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hepatitis C Virus (HCV) RNA concentrations in the blood. |  | 72 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C
Effects of Exercise Training in Chronic Obstructive Pulmonary Disease Versus Alpha-1-Antitrypsin-deficiency-patients

Study Overview
=================
Brief Summary
-----------------
Chronic Obstructive Pulmonary Disease (COPD)-patients (caused by smoking-level) and Alpha-1-Antitrypsin-deficiency patients showed different developments during rehabilitation in regard to improvement of 6-minute-walking distance. The aim of this study is to investigate differences between training adaptations in COPD-patients and Alpha-1-deficiency patients. Both groups take part in a standardized multimodal 3-week-rehabilitation with strength and endurance training. In addition to conventional diagnostic procedures, muscle biopsies from the M. vastus lateralis will be conducted before and after rehabilitation program followed by biochemical, histochemical and immunohistochemical analysis of the probes.

Official Title
-----------------
Effects of Exercise Training on Quadriceps Gene Expression in COPD-patients in Comparison to Alpha-1-Antitrypsin-deficiency-patients

Conditions
-----------------
Chronic Obstructive Pulmonary Disease, Alpha-1-antitrypsin-deficiency

Intervention / Treatment
-----------------
* Procedure: exercise training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD Alpha-1-Antitrypsine-deficiency, phenotype: ZZ FEV1%pred. <50 Exclusion Criteria: acute exacerbation exacerbation in the last 4 weeks

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: exercise training<br> | Procedure: exercise training<br>* strength and endurance training, 5 time per week.<br>* Other names: strength training;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| aerobic and anaerobic enzymes | changes in quantity of enzymes from baseline to day 23 | day 2 and 23 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maximal exercise capacity in incremental cycling test | Change in max. exercise capacity from baseline to day 23 | day 2 and 23 | 
| 6-minute-walking distance | change in 6-minute-walking distance from baseline to day 24 | day 3 and 24 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alpha-1-antitrypsin-deficiency, COPD, exercise training, muscle biopsy
A Pilot Study on Usefulness of Probe-based Confocal Laser Endomicroscopy Targeted Gastric Biopsy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to conduct a study on genetic pathology, obtaining of pure cancer tissues is mandatory. Although the endoscopy with biopsy has been a gold standard for diagnosing gastric cancer, percentage of cancer cells in biopsy samples is usually 30% or less. Recently, confocal laser endomicroscopy has been introduced for real-time histopathologic diagnosis in various cancers. The investigators aim to evaluate that biopsy using probe-based confocal laser endomicroscopy will increase the percentage of cancer cells in biopsy samples.

Conditions
-----------------
Gastric Cancer

Intervention / Treatment
-----------------
* Procedure: Probe-based confocal laser endomicroscopy
* Procedure: White light endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age, between 20 and 80 Initial-onset gastric cancer which would be treated with surgery Exclusion Criteria: Previous subtotal gastrectomy Pregnancy or breast milk feeding Active infection Significant cardiopulmonary disease Active hepatitis or severe hepatic dysfunction Severe renal dysfunction Severe bone marrow dysfunction Severe neurologic or psychotic disorder

Ages Eligible for Study
-----------------
Minimum Age: 20 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Probe-based confocal laser endomicroscopy<br> | Procedure: Probe-based confocal laser endomicroscopy<br>* In this arm1, an investigator observes a cancerous lesion using white light endoscopy. In addition, contrast dye for confocal laser endomicorscopy (fluorescein sodium 0.1mL/kg) is administered. Then, the cancerous lesion is observed using probe-based confocal laser endomicroscopy. The biopsy would be done 5 times at the most suspcious parts of the cancerous lesion.<br>|
| Active Comparator: White light endoscopy<br> | Procedure: White light endoscopy<br>* In this arm2, an invesigator observes a cancerous lesion using white light endoscopy. The biopsy would be done 5 times at the most suspicious parts of the cancerous lesion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The percentage of cancer cells in biopsy samples | The percentages of cancer cells in biopsy samples according to the method of endoscopic method, probe-based confocal laser endomicroscopy versus white light endosocpy | After 3 days from the end of the endoscopic submucosal dissection |