linjc16/ctgov huggingface dataset:
18F-DCFPyL PET/MRI in Regional Nodal&Distant Metastases Detection in Intermediate &HR Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to see if patients' tumor can be identified by 18F-DCFPyL PET/MRI scan. The radioactive study agent, 18FDCFPyL, combined with PET/MRI scan may be able to identify smaller tumors than the standard of care contrast-enhanced CT or MRI scan.

Detailed Description
-----------------
This is an expanded access study with a total of 100 participants with newly diagnosed intermediate or high-risk prostate cancer scheduled to undergo prostatectomy and lymph node dissection.

Official Title
-----------------
18F-DCFPyL PET/MRI for Detection of Regional Nodal and Distant Metastases in Patients With Intermediate and High-risk Prostate Cancer

Conditions
-----------------
Prostate Cancer

Intervention / Treatment
-----------------
* Drug: F18-DCFPyL
* Drug: Gadolinium
* Procedure: Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is older than 18-year-old Biopsy proven prostate adenocarcinoma Planned prostatectomy with lymph node dissection Intermediate to high-risk disease (as determined by elevated Prostate-specific antigen (PSA) [PSA>10], T-stage [T2b or greater], Gleason score [Gleason score > 6] or other risk factors) Able to provide written consent Karnofsky performance status of ³50 (or Eastern Cooperative Oncology Group (ECOG) /World Health Organization (WHO) equivalent) Exclusion Criteria: Neoadjuvant chemotherapy or radiation therapy prior to prostatectomy including focal ablation techniques (HiFu) Androgen deprivation therapy or other neoadjuvant treatments prior to PET imaging surgery Metallic implants (contraindicated for MRI)

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: F18-DCFPyL|Participant will be injected iv with 9 mCi ± 20% of 18F-DCFPyL|
|Drug: Gadolinium|Contrast agent|
|Procedure: Positron emission tomography (PET)/Magnetic Resonance Imaging (MRI) Scan|Imaging test that combines PET (positron emission tomography) and MRI (magnetic resonance imaging)|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Essen Coronary Artery Disease Registry

Study Overview
=================
Brief Summary
-----------------
The ECAD registry is a registry of patients undergoing coronary angiography at the West German Heart and Vascular Center. The registry anticipates to determine predictors of patient outcome after coronary angiography.

Official Title
-----------------
Essen Coronary Artery Disease Registry

Conditions
-----------------
Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing invasive coronary angiography at the West German Heart and Vascular Center Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Coronary angiography arm<br>Patient undergoing invasive coronary angiography | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality | Mortality of any cause | through study completion, an average of 3 year |
Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)

Study Overview
=================
Brief Summary
-----------------
Highly selective irradiation requires accurate target definition by high-resolution three-dimensional imaging. Co-registration of FDG-PET and high-resolution CT might be the imaging modality of choice. This choice might target radiation therapy precisely to the intra-osseous volume that is responsible for pain and to spare selectively healthy bone in the vicinity of the metastasis. This strategy could result in equal anti-pain efficacy as conventional large volume radiotherapy, but could allow bone remodeling and preservation of bone structural strength in the vicinity and could lead to reduced toxicity to neighboring organs.

Official Title
-----------------
Biological Imaging Guided Antalgic Radiotherapy of Bone Metastases (Phase II Trial)

Conditions
-----------------
Bone Metastases

Intervention / Treatment
-----------------
* Procedure: Biological imaging guided antalgic radiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Painful bone metastasis of solid tumors A maximum number of bone metastases less or equal to 3 Life expectancy > 6 months Minimum age 21 years Signed informed consent Exclusion Criteria: Previous radiotherapy to the painful site Bone metastasis from malignant melanoma or renal cell carcinoma Associated fracture or extra-osseous component

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Patients undergoing imaging guided radiotherapy.<br> | Procedure: Biological imaging guided antalgic radiotherapy<br>* Biological imaging guided antalgic radiotherapy is followed.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment |  | t0 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Acute toxicity |  | t0 | 
| Bone remodeling |  | t0 | 
| Resulting volumes of the targets and functional active areas |  | t0 | 
| Mismatch and/or overlap areas |  | t0 |
Arabic Version of Identification of Functional Ankle Instability Questionnaire

Study Overview
=================
Brief Summary
-----------------
Testing the validity and reliability of IdFAI

Detailed Description
-----------------
reliability & validity of Identification Functional Ankle Instability Questionnaire (IdFAI) Arabic version were assessed in reference to Lower Extremity Functional Scale among repeated ankle sprains college students in Cairo. These college students were randomly selected from different colleges in Cairo University

Official Title
-----------------
The Arabic Version of Identification of Functional Ankle Instability Questionnaire(IdFAI-Ar)

Conditions
-----------------
Assessment

Intervention / Treatment
-----------------
* Other: IdFAI questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: eighty six male and female college students will voluntarily participate in the study Exclusion Criteria: Previous ankle surgery. History of any ankle surgery. History of fracture within the last 6 months. Been involved in any previous strengthening or athletic training program.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 24 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: IdFAI questionnaire|The Identification of Functional Ankle Instability (IdFAI) is a newly published questionnaire that was specifically designed to detect whether individuals meet a minimum criteria necessary for inclusion in an FAI population. The IdFAI is intended to give both researchers and clinicians a simple and effective tool to determine an individual's ankle stability status|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Validity | Correlation coefficient | 3 months | 
| Reliability | Cronbach's Alpha | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Arabic, questionnaire, ankell instability
Perioperative Three Dimensional Right Ventricular Function

Study Overview
=================
Brief Summary
-----------------
This study addresses the influence of anesthesia induction, ventilation and influence of cardiac surgical procedures and cardio-pulmonary-bypass on right ventricular function. Influence on patient outcome is also studied. Three dimensional echocardiography is applied.

Official Title
-----------------
Perioperative Three Dimensional Right Ventricular Function

Conditions
-----------------
Heart Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: informed consent given cardiac surgical procedure left sided cardiac surgery or bypass surgery, ascending aortic surgery, assist device implantation Exclusion Criteria: pregnant patients contraindication for transesophageal echocardiography

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time on Intensive Care Unit (ICU) | Duration of ICU stay | up to 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to hospital discharge | Hospital Outcome | up to 120 days | 
| Catecholamine dosages | after anesthesia induction, end of surgery, 12h and 24h after intensive care unit (ICU) admission | up to 24 hours | 
| Catecholamine free days | Catecholamine free days on ICU | up to 60 days | 
| Hours on mechanical ventilation | Duration of mechanical ventilation | up to 1440 hours | 
| Organ failure during ICU stay | Early organ failure (Lab tests: Creatinine, Bilirubin, Lactate, Thromboplastin Time) | up to 60 days |
Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy

Study Overview
=================
Brief Summary
-----------------
To compare intraoperative and postoperative outcomes of Bartholin marsupialisation versus excision

Detailed Description
-----------------
Bartholin cysts and abscess are commonly seen. Different surgical procedures are done for therapy. Our aim is to compare intraoperative results and postoperative healing of patients undergoing marsupialisation versus excision.

Official Title
-----------------
Comparison of Intraoperative and Postoperative Outcomes of Bartholin Gland Marsupialisation Versus Cystectomy

Conditions
-----------------
Bartholin Abscess

Intervention / Treatment
-----------------
* Other: Excision
* Other: Marsupialization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-40, Bartholin cyst/abscess Exclusion Criteria: patients with systemical diseases, patients with recurrent Bartholin abscess

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Marsupialization<br>Bartholin gland marsupialization will be done to all patients with Bartholin abscess. | Other: Marsupialization<br>* Bartholin gland will be marsupialised<br>|
| Other: Excision<br>Bartholin gland excision will be done to all patients with Bartholin abscess. | Other: Excision<br>* Bartholin gland will be excised<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative | Patients will be followed up for three months. 3 months after the surgery, all patients will be asked to complete the Female Sexual Function Index (FSFI) questionnaire alone in a hospital room. The FSFI includes a total of 19-item validated questionnaire which was used for the evaluation of sexual desire, arousal, lubrication, orgasm, satisfaction, and pain during sexual intercourse. Scores range from 2 to 36, higher scores indicate better sexual function. Sexual dysfunction is described as having a total FSFI score of 26.55 or less. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operation time | operation time during the procedure will be recorded. | during procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bartholin, marsupialisation, abscess
Efficacy and Safety Evaluating Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to assess and compare the preliminary efficacy, safety and tolerability of fispemifene 300 mg and placebo given once daily for 8 weeks in the treatment of hypogonadal men with erectile dysfunction (ED) unresponsive to PDE5 inhibitors.

Official Title
-----------------
Efficacy and Safety of Fispemifene in the Treatment of Hypogonadal Men With Erectile Dysfunction Unresponsive to PDE5 Inhibitors: An 8-Week, Randomized, Double-Blind, Placebo-Controlled Study

Conditions
-----------------
Hypogonadism, Erectile Dysfunction

Intervention / Treatment
-----------------
* Drug: Fispemifene (once daily for 8 weeks)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypogonadal (morning total testosterone levels ≤400 ng/dl) men age ≥20 with ED who are unresponsive to PDE5 inhibitors, as demonstrated by International Index of Erectile Function (IIEF) results for 28-day lead in period.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Fispemifene (once daily for 8 weeks)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in the IIEF erectile function domain score from baseline to Week 8/Early Termination; |  |  | 
| Change in total testosterone levels from baseline to Week 8/Early Termination |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypogonadism, Erectile Dysfunction
Center for the Study of Vascular Disease in Hispanic and Native Americans

Study Overview
=================
Brief Summary
-----------------
This is a working registry of a longitudinal cohort of Hispanics, Native Americans, and non-Hispanic whites (as controls) for tracking of vascular disease endpoints. Blood samples collected for ongoing pilot projects as well as specimen banking. Pilot studies are observational and involve risk measures for stroke, atherosclerosis, and vascular inflammatory responses. Questionnaires on demographics, risk factors, and vascular disease history are performed. No interventions proposed as yet.

Official Title
-----------------
Center for the Study of Vascular Disease in Hispanic and Native Americans

Conditions
-----------------
Vascular Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Hispanics and Native Americans are oversampled, but non-Hispanic whites will be included for comparison purposes. No other exclusion criteria.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vascular Diseases
PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the incidence of clinically significant rhythm and rate changes in ED patients who are not placed on conventional telemetry, and to test the user-friendliness of a automated clinician alter device in hectic and noisy setting of a busy emergency room.

Official Title
-----------------
PREVENT - Prospective Rhythm Event Surveillance in the ER With NetGuard

Conditions
-----------------
Cardiac Event

Intervention / Treatment
-----------------
* Procedure: NetGuard Automated Clinician Alert System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 yes Agree to participate in study Telemetry not indicated Telemetry not available Willingness to complete a questionnaire- Exclusion Criteria: Refusal to participate Know sensitivity to adhesive Language/communication barriers Perceived high risk for lack of study compliance

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: 1<br>ED patients that are not monitored with conventional therapy. | Procedure: NetGuard Automated Clinician Alert System<br>* Monitoring System for in-hospital patients who are typically unmonitored. Identifies and alarms for cardiac rhythm changes.<br>* Other names: NetGurard Automated Clinican Alert Systemm;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of clinically significant rhythm and rate changes in ED patients. |  | Patient ED stay | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of user-friendliness of the device. |  | Patient ED stay | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac rhythm changes
Efficacy and Safety of Red Ginseng on Decrement of Body Fat

Study Overview
=================
Brief Summary
-----------------
The investigators performed a 12-week, randomized, double-blind, placebo-controlled human trial to evaluate the efficacy and safety of red ginseng on decrement of body fat. The investigators measured decrement of body fat parameters , including Body Fat Mass, Percent Body Fat, weight and BMI(body mass index), and monitored their blood pressure.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Dietary Supplement: Red Ginseng
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females 19-65 years old BMI(body mass index) ≥ 25 kg/m^2 or WC(Waist Circumference) ≥ 90(men), WC ≥ 85(women) Able to give informed consent Exclusion Criteria: Significant variation in weight(more 10%) in the past 3 months Allergic or hypersensitive to any of the ingredients in the test products History of reaction to any of the test products or of gastrointestinal diseases such as Crohn's disease or gastrointestinal surgery History of alcohol or substance abuse Participation in any other clinical trials within past 2 months Laboratory test, medical or psychological conditions deemed by the investigators to interfere with successful participation in the study Pregnant or lactating women etc.

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

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Red Ginseng<br> | Dietary Supplement: Red Ginseng<br>* Red Ginseng (1.4g/day)<br>|
| Placebo Comparator: Placebo<br> | Dietary Supplement: Placebo<br>* Placebo (1.4g/day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in Body Fat Mass | Body Fat Mass was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in Percent Body Fat | Percent Body Fat was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in weight | Weight was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks | 
| Changes in BMI(body mass index) | BMI(body mass index) was measured in study visit 1(0 week) and visit 3(12 week). | 12 weeks |