linjc16/ctgov huggingface dataset:
Study Evaluating the Correlation Between C-11 Acetate Uptake and Retention as Measured by PET and FAS in Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to understand if a new type of radiology test called positron emission tomography (PET) with carbon 11 acetate will help us to understand which cancers produce more of a protein called fatty acid synthase (FAS).

Detailed Description
-----------------
Within 4 weeks of the patient's scheduled surgery they will undergo a C11 acetate PET scan. This scan will be performed at the Massachusetts General Hospital's Nuclear Medicine Department and involves an intravenous injection of acetate with a radioactive tracer followed by a PET scan. The scan will determine how well the tumor is taking up the acetate. Patients will also undergo a CT scan of the pelvis at the same time as the PET scan. After surgery, the removed tumor will have additional testing that will look at different factors that may tell us how aggressive the tumor is and how much FAS is within the tumor. FAS seems to be produced in higher amounts by prostate cancer cells than normal cells. We will then try to determine if the results of the C11 acetate PET scan can tell us how much FAS is produced by prostate cancer cells.

Official Title
-----------------
A Pilot Study Evaluating the Correlation Between Carbon 11 Acetate (C-11 Acetate) Uptake and Retention as Measured by Positron Emission Tomography (PET) and Fatty Acid Synthase (FAS) Expression in Prostate Cancer

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

Intervention / Treatment
-----------------
* Procedure: C-11 acetate PET scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically documented prostate cancer Planned radical prostatectomy > 50% cores positive for prostate cancer from prostate biopsy or a palpable prostate nodule Older than 18 years of age Exclusion Criteria: Inability to lay on a scanner for 60 minutes

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: C-11 acetate PET scan|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the associations between measures of C-11 acetate uptake and retention into prostate tumors and levels of FAS expression in tissue. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PET, Prostate Cancer, positron emission tomography, carbon 11 acetate, fatty acid synthase, FAS
Survey Based Discrete Choice Experiment Study in Prostate Cancer (DECIDER) Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to quantify and publish participants' relative preferences for outcomes of chemotherapy and novel oral hormonal agents when added to androgen deprivation therapy (ADT) for participants with locally-advanced and metastatic hormone-sensitive prostate cancer (mHSPC). This study will also quantify the importance of administration factors related to convenience relative to treatment outcomes.

Detailed Description
-----------------
The study will develop and administer a discrete-choice experiment (DCE) to quantify tradeoff preferences of participants with mHSPC and locally-advanced prostate cancer in various countries. Data/surveys are being collected in: United States, Canada, UK, France, Spain, Japan, China and South Korea.

Official Title
-----------------
Prospective Evaluation of Patient Preferences for Outcomes of Hormonal Agents and Chemotherapy in Combination With Androgen Deprivation Therapy

Conditions
-----------------
Prostate Cancer, Metastatic Hormone-sensitive Prostate Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For interviews (attribute prioritization and pretest interviews) Diagnosis of mHSPC with or without previous experience with ADT Able to read and understand the survey language Able to provide informed consent For online survey Diagnosis of mHSPC or locally-advanced prostate cancer with or without previous experience with ADT Able to read and understand the survey language Able to provide informed consent Exclusion Criteria: Not applicable

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

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

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 |
| --- | --- | --- |
| Log-odds (preference weights) by participant cancer type and country | Log-odds indicate participants' relative preferences for treatments with each attribute level in the study, all else equal. | 1 day (once through survey) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relative importance weights by participant type and country | These weights indicate the overall influence of each study attribute on choice. | 1 day (once through survey) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostate cancer, metastatic hormone-sensitive prostate cancer, observational
Aachen Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device to Reduce Mitral Regurgitation

Study Overview
=================
Brief Summary
-----------------
Improvement in heart failure with moderate to severe mitral regurgitation using a percutaneously delivered implanted device

Official Title
-----------------
An Open-Label, Single-Arm Pilot Study of the Safety and Efficacy of the Percutaneous Transvenous Mitral Annuloplasty Device Used to Reduce Mitral Regurgitation

Conditions
-----------------
Heart Failure, Mitral Regurgitation

Intervention / Treatment
-----------------
* Device: PTMA Implant


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Symptomatic heart failure functional MR 2+ - 4+ LVEF 20% - 50% Exclusion Criteria: MR of organic origins significant co-morbidities

Ages Eligible for Study
-----------------
Minimum Age: 50 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: 1<br>Patient is screened for study and given baseline assessments. Patient receives a diagnostic PTMA assessment and if responsive, receives a PTMA implant. | Device: PTMA Implant<br>* Percutaneous assessment from right or left subclavian vein, with PTMA implant in the coronary sinus, great cardiac vein.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of patients who remain free from device-related major adverse events: death, myocardial infarction, tamponade, emergent cardiac surgery |  | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percent of implanted patients who maintain a sustained 1 grade reduction in mitral regurgitation and reduction in mitral anterior posterior dimension |  | 30 days | 
| improvement of clinical symptoms of heart failure as defined by percent of implanted patients who exhibit one of the following: decrease in NYHA class, improvement in Minnesota QOL survey, increase in 6 minute walk, improvement in VO2 max. |  | 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure, Mitral Regurgitation
Dose Finding Study for Retarded Phosphatidylcholine in Pancolitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find the optimal dose of retarded release Phosphatidylcholine in the most severe form of ulcerative colitis. The hypothesis is that ulcerative colitis (UC) is caused by a barrier dysfunction of the colonic mucus layer. The background of the study is the finding, that the phosphatidylcholine (PC) content of the colonic mucus is strongly reduced in UC compared to healthy controls and patients with Crohn´s disease. The content was meuasured in non-inflamed areas of the colon in UC. Thus, we evaluate whether a substitution of colonic PC is an effective method.

Detailed Description
-----------------
Design: prospective, randomized, double-blind, dose-finding study with retarded phosphatidylcholine. Population: 10 patients per dose group (6 doses) - 60 patients Remark: this includes to historic groups from another study Inclusion criteria: Ulcerative Pancolitis with chronic active course and a clinical index (Rachmilewitz) over 7 and more, endoscopic index of at least 7 or more. No systemic steroids or immunosuppressants since 4 weeks. Exclusion criteria: Pregnancy & fulminant course

Official Title
-----------------
Prospektive, Randomisierte Doppelblinde Studie Zur Dosisfindung Von Intestinal Redardiert Freigesetztem Phosphatidylcholin Bei Chronisch Aktiver Pancolitis Ulcerosa

Conditions
-----------------
Ulcerative Colitis

Intervention / Treatment
-----------------
* Drug: retarded release phosphatidylcholine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic active ulcerative pancolitis course more than 4 months clinical index rachmilewitz 7 or more endoskopic index 7 or more Exclusion Criteria: steroids in the last 4 weeks immunosuppressants in the last 4 weeks use of topical klymsa pregnancy fulminant course infectious colitis

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: retarded release phosphatidylcholine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute change in clinical activity index (Rachmilewitz). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Secondary end points include >50% changes in clinical and endoscopic activity index (EAI). |  |  | 
| Histology and life quality are reported descriptively. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ulcerative Colitis, Dose Finding, Phosphatidylcholine
Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder for Subjects That Have Completed Participation in 331-201-00148

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the long-term safety and tolerability of brexpiprazole in children and adolescent patients, aged 5 to 17, with irritability associated with autism spectrum disorder.

Official Title
-----------------
A Phase 3, Multicenter, Open Label Trial to Evaluate the Long-term Safety and Tolerability of Brexpiprazole in Treatment of Children and Adolescents With Irritability Associated With Autism Spectrum Disorder

Conditions
-----------------
Irritability Associated With Autism Spectrum Disorder

Intervention / Treatment
-----------------
* Drug: Brexpiprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 5 to 17 year of age or turned 18 while enrolled in the 331-201-00148 study Autism Spectrum Disorder Completion of 331-201-00148 trial Investigator assessment Exclusion Criteria: Did not complete treatment period or incurred significant protocol deviations during 331-201-00148 study Sexually active males or female of childbearing potential who do not agree to practice 2 different methods of birth control or remain abstinent during the trial and for 30 days after the last dose Female with positive pregnancy test

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 17 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: Arm 1<br>Brexpiprazole | Drug: Brexpiprazole<br>* Oral tablet; taken once daily<br>* Other names: LuAF41156;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events | Adverse Events occurring from baseline to Week 26 | Baseline to Week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Aberrant Behavior Checklist (ABC-I) | Aberrant Behavior Checklist- Irritability subscale score (ABC-I) | Baseline to Week 26 | 
| Clinical Global Impression (CGI-S) | Clinical Global Impression - Severity (CGI-S) | Baseline to Week 26 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Autism, Autism Spectrum Disorder, ASD, Irritability
Moviprep® Versus Fleet Phospho-Soda® (Golden Standard): A Study That Compared Two Laxatives on Patients Undergoing Colo-Rectal Cleansing Prior to an Abdominal Operation

Study Overview
=================
Brief Summary
-----------------
The patients are assigned by randomisation on one of the two laxatives. After cleansing they have to fill in an evaluation form to report their findings and difficulties. Also the surgeon will be asked to fill in a score-form to report all details concerning the bowel preparation.

Official Title
-----------------
Moviprep® Versus Fleet Phospho-Soda® (Golden Standard): A Study That Compared Two Laxatives on Patients Undergoing Colo-Rectal Cleansing Prior to an Abdominal Operation.

Conditions
-----------------
Colorectal Cleansing Prior Operation

Intervention / Treatment
-----------------
* Drug: Moviprep®
* Drug: Fleet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women Older than 18 Informed consent signed Mode of surgery Exclusion Criteria: Renal disease Heart failure Dehydration Abdominal obstruction Abdominal perforation Abdominal paralysis Toxic megacolon

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: Moviprep®<br>* use of Moviprep®<br>|
| Active Comparator: 2<br>Use of Fleet | Drug: Fleet<br>* Use of Fleet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colorectal cleansing |  | prior operation |
Emotional Reaction and Self Injury in Patients With Borderline Personality Disorder and Healthy Controls

Study Overview
=================
Brief Summary
-----------------
The current study investigates the emotional response of patients with borderline personality disorder and healthy controls on stimuli associated with self-injury.

Official Title
-----------------
Emotional Reaction of Patients With Borderline Personality Disorder (BPD)on Stimuli Connected to Self-injury - A Comparison Between Patients With BPD and a Healthy Control Group.

Conditions
-----------------
Borderline Personality Disorder, Emotions

Intervention / Treatment
-----------------
* Other: Stimuli presentation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients that are able to use skills and have some therapy experiences. Exclusion Criteria: Severe psychiatric comorbidity e.g. psychosis, severe depression, suicidality

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Patients with Borderline Personality Disorder<br> | Other: Stimuli presentation<br>* Different stimuli associated with self-injury are presented. Participants have to rate the emotional effect elected by the stimuli.<br>|
| Healthy controls<br> | Other: Stimuli presentation<br>* Different stimuli associated with self-injury are presented. Participants have to rate the emotional effect elected by the stimuli.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Emotional reaction | Patients comparded to healthy controls will show a stronger emotional reaction on the stimuli. Patients more severely affected will show a stronger emotional reaction compared to less affected patients. | one session of 90min |
Growth and Tolerance of Hypoallergenic Formulas

Study Overview
=================
Brief Summary
-----------------
This clinical trial will evaluate two investigational hypoallergenic infant formulas with a differing protein content to determine if they provide normal growth and are well tolerated by term infants as compared to a marketed hypoallergenic formula.

Official Title
-----------------
The Effects on Growth and Tolerance of Hypoallergenic Formulas Fed to Term Infants

Conditions
-----------------
Growth of Term Infants

Intervention / Treatment
-----------------
* Other: Infant formula


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton, 12-16 days of age at randomization Term infant with birth weight of a minimum of 2500 grams Solely formula fed Signed Informed Consent and Protected Health Information Exclusion Criteria: History of underlying metabolic or chronic disease or immunocompromised Feeding difficulties or formula intolerance

Ages Eligible for Study
-----------------
Minimum Age: 12 Days
Maximum Age: 16 Days

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 |
| --- | --- |
| Control<br>Marketed hypoallergenic infant formula containing a probiotic | Other: Infant formula<br> <br> |
| Experimental 1<br>An investigational hypoallergenic infant formula with a different protein content, containing the same probiotic as the control | Other: Infant formula<br> <br> |
| Experimental 2<br>An investigational hypoallergenic infant formula with a different protein content, without a probiotic | Other: Infant formula<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body weight measured at each study visit |  | 3.5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recall of infant formula intake at each study visit |  | 3.5 months | 
| Body Length and Head Circumference measured at each study visit |  | 3.5 months | 
| Recall of stool characteristics and tolerance at each study visit |  | 3.5 months | 
| Medically-confirmed adverse events collected throughout the study period |  | 3.5 months | 
| Parental Product Assessment Questionnaire completed at Study Visit 2 |  | once |
ADCC Against Gastric Cancer Cells

Study Overview
=================
Brief Summary
-----------------
Peripheral blood will be taken from the enrolled patients at National University Hospital and from healthy volunteers. ADCC assay will be performed for evaluating efficacy of new medicine candidates.

Official Title
-----------------
Evaluation of Antibody-dependent Cell Cytotoxicity (ADCC) Against Gastric Cancer Cells

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For the gastric cancer patients, patients with 21 years of age and above and younger than 80 years old who have gastric cancer can enroll in this study. For the healthy donors, healthy volunteers with 21 years of age and above and younger than 80 years old can enroll in this study. Exclusion Criteria: (A) Age of <21 and >80 years old (B) Pregnancy (C) Decision of unsuitableness by Principal Investigator or physician-in-charge

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Percentage of cell lysis |  | within 1 year |