linjc16/ctgov huggingface dataset:
Post Marketing Surveillance Study to Observe Safety and Efficacy of Inlyta in South Korea

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to monitor the usage of INLYTA® in real practice within label, including the adverse events associated with INLYTA®.

Detailed Description
-----------------
This is observational, non-interventional multi-center study in which subjects will be administered as part of routine practice at Korean health care centers by accredited physicians.

Official Title
-----------------
POST MARKETING SURVEILLANCE STUDY TO OBSERVE SAFETY AND EFFICACY OF INLYTA (REGISTERED)

Conditions
-----------------
Advanced Renal Cell Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as advanced renal cell carcinoma (aRCC) after failure of one prior systemic therapy. Patients to whom INLYTA® is first administered or patients who are already on INLYTA® during the study period Evidence of a personally signed and dated informed consent document indicating that the patient (or a legally acceptable representative) has been informed of all pertinent aspects of the study. Exclusion Criteria: Any patient who does not agree that Pfizer and companies working with Pfizer use his/her information Patients with hypersensitivity to axitinib or to any other component of INLYTA® Patients under 18 Pregnant women

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 |
| --- | --- | --- |
| Adverse Event incidence | The clinical nature, incidence, duration, and severity of adverse events; discontinuation due to adverse events; outcome and possible causality will be monitored in this study. | bimonthly up to 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumor Response | Tumor response based on RECIST 1.1 | bimonthly up to 24 months | 
| Objective Response Rate (ORR) | ORR(Objective Response Rate) : the proportion of patients who have a partial or complete response to therapy | bimonthly up to 24 months | 
| Progression Free Survival (PFS) within limited follow-up period | Progression free survival (PFS) within limited follow up period due to limitation of study design (observation, non-interventional) | bimonthly up to 24 months | 
| Time To Progression (TTP) | defined as the time to progression is one way to see how well a new treatment works | bimonthly up to 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Korean PMS of Axitinib, Metastatic RCC ; 2nd line only
Pediatric Radio Frequency Coils Generic

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate and optimize advances in radio frequency (RF) coil magnetic resonance imaging (MRI) technology at Cincinnati Children's Hospital Medical Center (CCHMC).

Detailed Description
-----------------
Pediatric Magnetic resonance (MR) imaging techniques have been limited by the unavailability of specialized radio-frequency (RF) coils for pediatric imaging. Typically, MR coils are designed for general purpose adult imaging and lack the mechanical design, flexibility and high channel count needed for pediatric imaging. Furthermore, pediatric patients are often positioned decubitus or prone rather than supine. This makes coil positioning even more challenging and often results in images with low SNR and poor image quality. Many coils used in clinical practice have fixed dimensions that do not fit within the realm of one-size fits all, especially for the huge variation found in the pediatric patient population. MRI coil development and optimization is performed by MR manufacturers and in research laboratories across the world including the Imaging Research Center (IRC) of Cincinnati Children's Hospital and Medical Center (CCHMC). Coil development and refinement involves evaluating the new coils on inert phantoms and then imaging examinations performed on healthy participants and patients. The focus of this study protocol is to evaluate the design and performance of investigational coils on patients and healthy participants.

Official Title
-----------------
Pediatric Radio Frequency Coil Development on Clinical and Research MR Scanners

Conditions
-----------------
Duchenne Muscular Dystrophy, Musculoskeletal Abnormalities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participants: Male or Female Thermally stable Any age Clinical patients: Male or Female Thermally stable any age Exclusion Criteria: Healthy participants & Clinical patients Female participants who are pregnant or lactating Subjects iwth standard contraindications to MRI
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 |
| --- | --- |
| Advances in Radio Frequency for MRI<br>advances in radio frequency (RF) coil magnetic resonance imaging (MRI) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events as measured by heating and comfort participant response |  | Day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI Image Quality |  | 2 Weeks Post MRI Scan | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging
Non-Invasive Jugular Venous Blood Volume Assessment (BVI)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the ability of the Mespere Blood Volume Index (BVI) device to calculate the blood volume in the jugular veins by comparing the measurements from the device to volumetric measurements obtained with ultrasound.

Official Title
-----------------
Non-Invasive Jugular Venous Blood Volume Assessment (BVI)

Conditions
-----------------
Ultrasound Evaluation

Intervention / Treatment
-----------------
* Diagnostic Test: BVI Device
* Diagnostic Test: Point-of-Care Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or greater English-speaking No known medical conditions requiring treatment by a physician Exclusion Criteria: Substantial amount of neck hair preventing adhesion of the neck patch of the BVI History of congenital heart disease History of thoracic, neck or brain surgery Inability to lay supine at 30 degrees incline or 60 degrees incline for the duration of the study measurements Pregnancy

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BVI Cohort<br>Cohort to have ultrasound and Mespere BVI device applied. | Diagnostic Test: BVI Device<br>* Non-Invasive measurement of jugular blood volume using Mespere BVI device<br>Diagnostic Test: Point-of-Care Ultrasound<br>* Point-of-Care ultrasound of external and internal jugular veins<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of jugular vein blood volume | Comparison of measurement of blood volume in jugular vein using BVI and POCUS | One Hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of changes in measurement of jugular venous blood volume | BVI vs POCUS at head of bed angle degrees 0, 30, and 60. | One Hour |
Clinical Effect of Chlorhexidine Mouthwash After Periodontal Surgery

Study Overview
=================
Brief Summary
-----------------
Chlorhexidine is the gold standard of dental plaque prevention. Recent research have demonstrated that 0.2% Chlorhexidine solutions are more effective than 0.12% and 0.06% Chlorhexidine solutions. Several 0.2% solutions are available on the market. This study aimed to compare effectiveness of two commercially available 0.2% chlorhexidine mouthwashes. Patients, that after initial periodontal therapy, had a need for two periodontal surgeries, will be invited to join. After one surgical session, the patient will receive one 0.2% chlorhexidine solution, and after the next surgical session the patient will receive the other 0.2% chlorhexidine solution. Plaque and gingivitis will be recorded, as well as side effects.

Official Title
-----------------
Clinical Performance of Two 0.2% Chlorhexidine Mouth Rinses After Periodontal Surgery. A Blinded, Intra-individual Cross-over Clinical Trial

Conditions
-----------------
Periodontal Diseases, Periodontitis, Dental Plaque

Intervention / Treatment
-----------------
* Drug: Chlorhexidine 0.2%, Corsodyl
* Drug: Chlorhexidine 0.2%, Curasept


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Periodontitis, stage III and IV Exclusion Criteria: Uncontrolled diabetes Systemic conditions associated with excessive bleeding Uncontrolled hypertension

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: Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: Intra individual cross-over, double intervention
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Chlorhexidine 0.2% mouthwash control<br>Chlorhexidine 0.2%, Corsodyl Intervention rinsing 60 sec twice daily | Drug: Chlorhexidine 0.2%, Corsodyl<br>* Comparison of Corsodyl and Curasept<br>|
| Experimental: Chlorhexidine 0.2% mouthwash with an Anti Discoloring System<br>Chlorhexidine 0.2%, Curasept Intervention rinsing 60 sec twice daily | Drug: Chlorhexidine 0.2%, Curasept<br>* Chlorhexidine 0.2% mouthwash with an Anti Discoloring System (ADS)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index | Dental Plaque | 14 days intervention period | 
| Gingival Index | Gingivitis | 14 days intervention period | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Periodontal Index
Postmarketing Surveillance Study of Atrovent® in Chronic Obstructive Airways Disease

Study Overview
=================
Brief Summary
-----------------
Study to obtain further information on the tolerability and efficacy of Atrovent® unit dose vial 500 µg in the treatment of Chronic Obstructive Airways Disease under conditions of daily practice

Official Title
-----------------
Postmarketing Surveillance Study (as Per §67(6)AMG[German Drug Law]) of Atrovent® Unit Dose Vial 500 µg in Chronic Obstructive Airways Disease

Conditions
-----------------
Pulmonary Disease, Chronic Obstructive

Intervention / Treatment
-----------------
* Drug: Atrovent®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primarily patients of both gender, older than 30 years, who suffer from chronic obstructive airways disease Only patients who had not been treated with Atrovent® within the last year were to be considered for inclusion Exclusion Criteria: Contraindication listed in the instructions for use/summary of product characteristics for Atrovent® unit dose vial 500 µg

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- |
| Chronic Obstructive Airways Disease<br> | Drug: Atrovent®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in total severity of the clinical picture rated on a 4-point scale |  | after 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of efficacy by investigator on a 4-point scale |  | after 4 weeks | 
| Assessment of efficacy by patient on a 4-point scale |  | after 4 weeks | 
| Assessment of tolerability by investigator on a 4-point scale |  | after 4 weeks | 
| Assessment of tolerability by patient on a 4-point scale |  | after 4 weeks | 
| Number of patients with adverse drug reactions |  | up to 4 weeks |
Open Label, Multicenter, Real World Practice of Durvalumab in Lung Cancer (Imfinzi PMS)

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to assess safety and efficacy of Imfinzi (durvalumab) in a real world setting in patients with non-small cell lung cancer (NSCLC) or SCLC treated with Imfinzi under the approved indication in Korea.

Detailed Description
-----------------
Primary objective : To assess safety of Imfinzi for patients with NSCLC or SCLC treated with Imfinzi under the approved indication in Korea Outcome Measure: Safety (adverse event (AE), serious adverse events (SAE), adverse drug reaction (ADR), serious adverse drug reaction (SADR), adverse events of special interest (AESI), adverse events leading to discontinuation (DAE), and adverse events leading to deaths (fatal AE)) Dose interruptions Duration of treatment Reason for treatment discontinuation Secondary objective: To assess efficacy of Imfinzi for patients with NSCLC or SCLC treated with Imfinzi under the approved indication in Korea Outcome Measure: Progression free survival (PFS) Objective response rate (ORR) Duration of response (DoR)

Official Title
-----------------
Open Label, Multicenter, Real World Practice of Durvalumab in Lung Cancer (Imfinzi PMS)

Conditions
-----------------
Lung Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for Imfinzi treatment according to the approved label; patients with NSCLC or SCLC Provision of signed and dated written informed consent by the patient or legally acceptable representative Exclusion Criteria: History of hypersensitivity to excipients of Imfinzi or to drugs with a similar chemical structure or class to Imfinzi Prior exposure to any anti-PD-1 or anti-PD-L1 inhibitors, including Imfinzi Pregnancy and/or breast feeding Current participation in any interventional trial Other off-label indications according to the approved label
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 |
| --- | --- | --- |
| Safety (AE, SAE, ADR, SADR, AESI, DAE, fatal AE) | safety outcome | for up to 1 year after the first dose of Imfinzi | 
| Dose interruptions | Safety outcome | for up to 1 year after the first dose of Imfinzi | 
| Duration of treatment | Safety outcome | for up to 1 year after the first dose of Imfinzi | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression free survival (PFS) | efficacy outcome | for up to 1 year after the first dose of Imfinzi | 
| Objective response rate (ORR) | efficacy outcome | for up to 1 year after the first dose of Imfinzi | 
| Duration of response (DoR) | efficacy outcome | for up to 1 year after the first dose of Imfinzi |
Duodenal Cancer - Retrospective Analysis

Study Overview
=================
Brief Summary
-----------------
To see how a cohorte of 55 patients over periode 1997-2011 were mannaged, treated and survived duodenal cancer. Also to see how advanced the tumors were at time of diagnose and at time of operation.

Official Title
-----------------
1997-2011 Duodenal Cancer Analysis in Southern Denmark

Conditions
-----------------
Duodenal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: duodenal cancer Exclusion Criteria: other cancers of the upper GI tract such as pancreatic cancer, cholangiocarcinoma, papilla Vateri cancer
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 |
| --- | --- | --- |
Analysis of Iliac Crest Biopsies From Patients Receiving Risedronate

Study Overview
=================
Brief Summary
-----------------
This study analysed and reported on the study data from three similar, risedronate studies, 1996052, 2003073, and 2003096. The objective of the study was to determine the differences in the iliac crest bone histomorphometry and bone quality in postmenopausal women who had received long term therapy with risedronate.

Official Title
-----------------
Bone Histomorphometry, Microarchitecture, and Matrix Structure in Patients Receiving Risedronate Daily or Weekly

Conditions
-----------------
Osteoporosis

Intervention / Treatment
-----------------
* Drug: risedronate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Completed month 36 of Study RVN-008993. Underwent an iliac crest bone biopsy at month 36. Exclusion Criteria: Was less than 60% compliant with regard to taking study drug from the start of the study drug to month 24 of study RVN-008993.
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Women taking risedronate for 5 years | Drug: risedronate<br>* risedronate tablet, 5 mg daily or 35 mg once weekly for 5 years<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in iliac crest bone histomorphometry and bone quality in patients receiving risedronate |  | 5 years |
Single and Multiple Dose Pharmacokinetics of Sufentanil NanoTab

Study Overview
=================
Brief Summary
-----------------
Determine the plasma concentration profile after single and multiple dosing of Sufentanil NanoTabs

Official Title
-----------------
Single- and Multiple-Dose Pharmacokinetics of Sublingual Sufentanil NanoTab® PCA System (Zalviso™) in Healthy Subjects

Conditions
-----------------
Plasma Concentrations

Intervention / Treatment
-----------------
* Drug: Single dose of SUF NT 15 mcg
* Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non smoking Ages 18 to 45 year, inclusive BMI between 18 and 30 Exclusion Criteria: Subjects taking any prescription or OTC medications or vitamins or supplements Pregnant females Subjects with pulmonary disease or sleep apnea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Single dose of SUF NT 15 mcg then 40 doses of SUF NT 15 mcg<br>Period 1: Single dose of SUF NT 15 mcg Period 2: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes | Drug: Single dose of SUF NT 15 mcg<br> <br> Drug: 40 consecutive doses of SUF NT 15 mcg taken every 20 minutes<br> <br> * Other names: Zalviso™;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | For Treatment A, serial blood samples were taken at 0 (predose), 5, 10, 15, 20, 30, 40, 50, 60, 70, 80, 90, 120, 180, 240, 360, 480, 600, 720, 800, and 840 minutes, and 24 hours after the Sufentanil NanoTab dose on Day 1. For Treatment B, serial blood samples were collected at 0, 20, 120, 240, 360, 480, 600, 720, 760, 780, 785, 790, 795, 800, 810, 820, 830, 840, 850, 860, 870, 900, 960, 1020, 1140, 1260, 1380, 1500, 1580, and 1620 minutes, and 37 hours after the first Sufentanil NanoTab dose on Day 3 | 24 hours in Treatment A, 37 hours in Treatment B | 
| Time to Steady State | Steady state, for the cohort, was assessed using Helmert's method (ratio of the geometric mean concentration of each time point to the geometric mean concentrations pooled over all remaining time points, and achieved at the first not-statistically significant time point (i.e., p >0.05) | 24 hours | 
| CST½ | the time for plasma concentrations to decrease from Cmax to 50% of Cmax after discontinuation of drug administration | 24 |