linjc16/ctgov huggingface dataset:
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With DWC202307 in Healthy Adult Volunteers

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the safety and the pharmacokinetics of DWJ1543 with concomitant multiple oral doses of DWC202307 in healthy adult volunteers.

Detailed Description
-----------------
The study design is a Randomized, Open-label, Oral, Single-dose, Two-way crossover study. The patients were randomly assigned to each group. Primary endpoint was Cmax and AUClast of DWP16001. Secondary endpoints were AUCinf, AUClast, Tmax, t1/2, CL/F, and Vd/F of DWJ1543.

Official Title
-----------------
Bioequivalence Study for the Safety and the Pharmacokinetics of DWJ1543 With Concomitant Multiple Oral Doses of DWC202307 in Healthy Adult Volunteers

Conditions
-----------------
Healthy Volunteers

Intervention / Treatment
-----------------
* Drug: DWC202307
* Drug: DWJ1543
* Drug: DWC202216


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Over 19 year old Healthy adult volunteer Exclusion Criteria: Eye disorders including cataracts Respiratory disorders including interstitial lung disease and pneumonitis and venous thromboembolic disorders

Ages Eligible for Study
-----------------
Minimum Age: 19 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention: DWC202307 + DWJ1543<br> | Drug: DWC202307<br>* DWC202307<br>Drug: DWJ1543<br>* DWJ1543<br>|
| Experimental: Intervention: DWC202307 + DWC202216<br> | Drug: DWC202307<br>* DWC202307<br>Drug: DWC202216<br>* DWC202216<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum plasma concentration at steady-state(Cmax,ss) of DWJ1543 |  | At pre-dose (0 hour), and post-dose 1 to 120 hour. | 
| Area under the curve from the time of dosing to the last measurable concentration(AUClast) of DWJ1543 |  | At pre-dose (0 hour), and post-dose 1 to 120 hour. |
The Relationship Between Bone Pelvis Measurements and Erectile Function in Patients Who Had Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation

Study Overview
=================
Brief Summary
-----------------
In order to evaluate the relationship between bone pelvis measurements and erectile function in patients who underwent nerve-sparing robot-assisted radical prostatectomy, bone pelvis measurements will be measured from MRI images of the patients before the operation and their erection quality will be evaluated with the IIEF-5 form. The erection quality of the same patients will be evaluated with the IIEF-5 form in the 3rd and 6th months after the operation. And it will be evaluated whether there is a relationship between the erection quality of the patients before and after the operation and their bone pelvis measurements.

Official Title
-----------------
The Relationship Between Bone Pelvis Measurements and Erectile Function in Patients Who Had Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation

Conditions
-----------------
Erectile Dysfunction

Intervention / Treatment
-----------------
* Procedure: Robot Assisted Radical Prostatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Having bilateral nerve-sparing robot-assisted radical prostatectomy operation Having a regular sexual life Exclusion Criteria: Having received neoadjuvant therapy Having a history of radiotherapy to the pelvic area The need to receive postoperative hormono-radiotherapy
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| preoperative patients<br> | Procedure: Robot Assisted Radical Prostatectomy<br>* Performing radical prostatectomy operation using robotic equipment while preserving bilateral nerve bundles<br>* Other names: Bilateral Nerve-Sparing Robot-Assisted Radical Prostatectomy Operation;|
| Patients in the 3rd postoperative month<br> | |
| Patients in the 6th month postoperatively<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ııef-5 score | The scale we use to evaluate patients' erection quality | three months |
Drug-coated Balloon in de Novo Chronic Total Occlusions

Study Overview
=================
Brief Summary
-----------------
The CTO-DENOVO study is a multicenter registry of consecutive patients with de novo CTO undergoing successful CTO recanalization with the use of DCB-only strategy. The primary endpoint is target lesion failure at 6 months. The secondary endpoints are: 1) late lumen loss on follow-up angiography, and 2) minimal lumen area on follow-up intravascular ultrasound.

Official Title
-----------------
Drug-coated Balloon in de Novo Chronic Total Occlusions (CTO-DENOVO Registry)

Conditions
-----------------
Coronary Artery Disease, Total Occlusion of Coronary Artery

Intervention / Treatment
-----------------
* Device: CTO PCI using DCB-only strategy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: de novo coronary CTO undergoing successful recanalization with the use of DCB-only strategy at the occlusion site Exclusion Criteria: de novo coronary CTO undergoing successful recanalization with the use of DES at the occlusion site in-stent CTO

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

| Intervention/Treatment |
| --- |
|Device: CTO PCI using DCB-only strategy|Successful CTO recanalization treated with DCB at the occlusion site|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Target lesion failure | Composite of cardiac death, target vessel-related myocardial infarction, or clinically-driven target lesion revascularization | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Late lumen loss | In-segment late lumen loss on follow-up angiography (in-segment equals DCB plus the proximal and distal 5-mm margins) | 3 months | 
| Minimal lumen area | In-segment minimal lumen area on follow-up IVUS (in-segment equals DCB plus the proximal and distal 5-mm margins) | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
chronic total occlusion, percutaneous coronary intervention, drug-coated balloon
The Value of MRI in Assessing the Status of Retroperitoneal Resection Margin in Colon Cancer

Study Overview
=================
Brief Summary
-----------------
The goal of this clinical trial is to explore the value of colon MRI in assessing the status of retroperitoneal resection margin (RPRM) for advanced colon cancer. The main questions it aims to answer are: Concordance between MRI suspected RPRM positive and pathologically confirmed positive. Can RPRM-positive patients undergo beyond complete mesocolic excision (CME) surgery in order to achieve R0 resection? Participants will undergo colon MRI examination and once MRI suspects RPRM positive, they will receive beyond CME surgery.

Official Title
-----------------
To Explore the Value of Colon MRI in Assessing the Status of Retroperitoneal Resection Margin Following Beyond Complete Mesocolic Excision Surgery for Advanced Colon Cancer

Conditions
-----------------
Colon Cancer

Intervention / Treatment
-----------------
* Procedure: Beyond complete mesocolic excision surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primary colon adenocarcinoma confirmed by biopsy preoperative CT suspecting retroperitoneal resection margin (RPRM) positive received colon MRI scan underwent beyond complete mesocolic excision surgery sufficient clinical and pathological results Exclusion Criteria: combined with other malignant tumors simultaneous distant metastasis definite invaded other organs or structures (T4b tumors)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suspected positive RPRM on MRI<br> | Procedure: Beyond complete mesocolic excision surgery<br>* If the participants were diagnosed with positive retroperitoneal resection margin (RPRM), they underwent beyond complete mesocolic excision surgery to ensure the R0 resection.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Coincidence rate with pathological result | Coincidence rate between MRI diagnosed retroperitoneal resection margin and pathologically confirmed positive | within 2 weeks after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Colon cancer, MRI, Resection margin
Outcomes of Functional Substrate Mapping of Ventricular Tachycardia

Study Overview
=================
Brief Summary
-----------------
The goal of this registry database is to demonstrate the safety and effectiveness of functional ventricular tachycardia (VT) ablation using SENSE protocol in patients with ischaemic VT. Mortality and the need for ICD therapies at 12 months post-ablation will be compared with propensity-matched controls undergoing substrate-based ablation alone.

Detailed Description
-----------------
This is an international multicentre prospective registry. Participating centres will collect data during the pre-assessment, procedure, and follow-up visits at 6 and 12 months, according to standard practice. It is anticipated that the enrolment duration will be approximately 12 months, with the data being matched with that collected from a control group of patients undergoing conventional Ventricular tachycardia ablation methods.

Official Title
-----------------
Outcomes of Functional Substrate Mapping of Ventricular Tachycardia (Func-VT) - an International Propensity-matched Prospective Registry

Conditions
-----------------
Ventricular Tachycardia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One of the following VT events (within the last 6 months) + Ejection Fraction <40%: A: ≥3 episodes of VT treated with anti-tachycardia pacing (ATP), at least one of which is symptomatic. B: ≥1 appropriate ICD shock. C: ≥3 VT episodes within 24 hr. D: Sustained VT below the detection rate of the ICD. Exclusion Criteria: Contraindication to VT ablation Renal failure (CrCl < 15 mL/min) NYHA IV or CCS IV angina STEMI within 1 month CABG within 3 months PCI within 1 month Pregnant Life expectancy < 1 year

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 |
| --- | --- | --- |
| Composite of cardiovascular mortality and ICD therapy | Composite of cardiovascular mortality and implantable cardioverter-defibrillator (ICD) therapy | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Length of hospital stay | 1 month | 
| Left ventricular function on echocardiogram | Left ventricular function on echocardiogram | 6 months |
Mahana Tinnitus Pilot

Study Overview
=================
Brief Summary
-----------------
The main objective of this prospective, open-label, non-significant risk study is to assess the efficacy and safety of Mahana™ Tinnitus together with care as usual in approximately 250 adults with symptoms of tinnitus.

Detailed Description
-----------------
Following informed consent, all participants will complete a series of screening questionnaires to determine eligibility for study entry. Eligible participants will be enrolled, and will receive access to MHNA-003 (Mahana™ Tinnitus). Participants will use MHNA-003 for 6 weeks, completing assessments at Baseline and Weeks 2, 4, and 6 following Baseline.

Official Title
-----------------
A Prospective, Open-Label Trial of MHNA-003, a Smartphone-Delivered Cognitive Behavioral Therapy (CBT) Treatment, in Adults With Symptoms of Tinnitus

Conditions
-----------------
Tinnitus

Intervention / Treatment
-----------------
* Device: MHNA-003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant scores ≥ 25 on the Tinnitus Functional Index. Participant has experienced symptoms of tinnitus for at least 3 months. Participant is at least 18 years of age at the time of consent. Participant resides in the United States. Participant is able to speak, read, and understand English. Participant has access to an iOS or Android smartphone with the ability to complete study tasks. Participant is able to commit the time required to complete therapy modules and study assessments. Exclusion Criteria: Participant scores ≥2 on item 9 (suicidal thoughts) of the Beck's Depression Index (BDI). Participant has been hospitalized for psychiatric reasons within 12 months of screening. Participant is currently enrolled in or plans to enroll in another clinical study that could impact outcomes of this trial.

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: MHNA-003<br>6-week digital therapy program designed to reduce the severity of tinnitus symptoms | Device: MHNA-003<br>* 6-week digital therapy program designed to reduce the severity of tinnitus symptoms<br>* Other names: Mahana™ Tinnitus;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in TFI Score from Baseline to Week 6 | The Tinnitus Functional Index (TFI) is a validated, 25-item questionnaire designed to measure the severity and negative impact of tinnitus. Total scores range from 0-100 with higher scores representing higher severity and more negative impact. An improvement of 13 or more points is considered a clinically meaningful change. | 6 weeks |
A Study to Assess the Safety and Pharmacokinetics of AD-104-A

Study Overview
=================
Brief Summary
-----------------
Primary endpoint of this study is to evaluate the pharmacokinetic characteristics of AD-104-A

Detailed Description
-----------------
The purpose of this study is to evaluate the pharmacokinetic characteristics of AD-104-A in Healthy Adult Volunteers and Patients with Renal Impairment

Official Title
-----------------
A Parallel, Open-Label, Single-Dose Administration, Phase 1 Clinical Study to Assess the Safety and Pharmacokinetics of AD-104-A in Healthy Adult Volunteers and Patients With Renal Impairment

Conditions
-----------------
Hyperlipidemias

Intervention / Treatment
-----------------
* Drug: AD-104-A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For all subjects Adults aged 19 years and older Body mass index(BMI) of 18 to 30 kg/m2 Voluntarily given written informed consent For renal Impairment subjects 30 ≤ eGFR < 90 mL/min/1.73m^2 For healthy subjects eGFR ≥ 90 mL/min/1.73m^2 Exclusion Criteria: Participation in another clinical study with an investigational drug within the 6 months from scheduled first administration Other exclusions applied

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Renal Impairment 1<br>Test Drug: AD-104-A | Drug: AD-104-A<br>* PO, Single-Dose, AD-104-A<br>|
| Experimental: Renal Impairment 2<br>Test Drug: AD-104-A | Drug: AD-104-A<br>* PO, Single-Dose, AD-104-A<br>|
| Experimental: Renal Impairment 3<br>Test Drug: AD-104-A | Drug: AD-104-A<br>* PO, Single-Dose, AD-104-A<br>|
| Experimental: Normal<br>Test Drug: AD-104-A | Drug: AD-104-A<br>* PO, Single-Dose, AD-104-A<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cmax | To assess the Cmax of AD-104-A | pre-dose to 192 hours | 
| AUC | To assess the AUC of AD-104-A | pre-dose to 192 hours |
Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis: A Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
Implantoplasty entails polishing of the implant surface during the surgical therapy of peri-implantitis. Given the controversy behind implantoplasty as surface decontamination method in the treatment of peri-implantitis, the goal of this clinical trial is to assess the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA) + implantoplasty in combined defects when compared to the extent of implantoplasty along the exposed implant surface upon the clinical resolution and radiographic bone gain in peri-implantitis sites treated by means of reconstructive therapy (Inteross® + autogenous bone, Sigmagraft, CA, USA).

Official Title
-----------------
Implantoplasty as Adjunct to Combined Surgical Therapy of Peri-Implantitis: A Randomized Clinical Trial

Conditions
-----------------
Peri-Implantitis

Intervention / Treatment
-----------------
* Procedure: Implantoplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria All patients in age of 18 to 80, non-smokers With no presence of systemic disease or medication known to alter bone metabolism, and partial or complete edentulous patients that have no active periodontal disease. Peri-implantitis defined according to the EFP/AAP consensus meeting Combined defect configuration Exclusion criteria: Pregnancy or lactation History of or current smokers Uncontrolled medical conditions, Cement-retained restoration Lacking keratinized mucosa (≤2mm) on the lingual or buccal implant sites.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized clinical trials with paired number of subjects
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Implantoplasty<br>Implantoplasty to all the implant surface | Procedure: Implantoplasty<br>* Implantoplasty as surface decontamination method<br>|
| Active Comparator: Implantoplasty on the supracrestal component<br>Implantoplasty only in the supra-crestal component and the infra bony hydrogen peroxide | Procedure: Implantoplasty<br>* Implantoplasty as surface decontamination method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease resolution | pocket depth <6mm, no bleeding on probing, no suppuration, no progressive bone loss | 12 months after surgery |
Correlation Between Dental Arch and Articular Eminence

Study Overview
=================
Brief Summary
-----------------
the aim of the study is to assess the correlation between the dental arch morphology and the articular eminence height and inclination by using CBCT scans of a sample of the Egyptian population.

Official Title
-----------------
Correlation Between the Dental Arch Morphology and the Articular Eminence Height and Inclination on CBCT Scans of an Egyptian Population: A Cross-Sectional Study.

Conditions
-----------------
Articular Eminence

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: • CBCT scans of adult Egyptian patients, males and females with ages starting from 18 till 45. Scans of patients who have complete set of permanent dentitions (third molars are not considered), or at least not more than one tooth is missed in each arch. CBCT scans with field of view that shows the full view of TMJ. Exclusion Criteria: • CBCT scans of patients with fractures in the articular bone surfaces. CBCT scans of patients with pathological lesions in the TMJ or articular eminence. CBCT scans with artifacts that could interfere with the assessment of the articular eminence and dental arches.

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ovoid dental arch<br> | |
| Square dental arch<br> | |
| Tapered dental arch<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the morphology of the dental arch and the articular eminence inclination. |  | Baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between the morphology of the dental arch and the articular eminence height. |  | Baseline | 
| Correlation between the dental arch measurements and the articular eminence height and inclination measurements. |  | Baseline |