linjc16/ctgov huggingface dataset:
An Open Label Extension Study of STX209 in Subjects With Fragile X Syndrome

Study Overview
=================
Brief Summary
-----------------
Study 22001, A Double-Blind, Placebo-Controlled, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects with Fragile X Syndrome currently is evaluating the efficacy of STX209 (R-baclofen) for management of typical problem behaviors, such as irritability and aggression, in subjects with FXS. This study (22002) will enter subjects who complete Study 22001 into a long-term, open-label study.The open-label extension protocol will provide necessary data on the long-term safety and tolerability of STX209 among subjects with FXS who receive treatment under conditions more closely reflective of their general medical care.

Official Title
-----------------
An Open Label Extension Study to Evaluate the Safety, Tolerability and Pharmacokinetics of STX209 in Subjects With Fragile X Syndrome

Conditions
-----------------
Fragile X Syndrome

Intervention / Treatment
-----------------
* Drug: Arbaclofen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have completed all scheduled visits in protocol 22001 and have shown they can adequately follow the protocol, with sufficient medical justification to continue on open-label treatment with STX209, as assessed by the principal investigator Exclusion Criteria: Subjects with a medical condition that might interfere with the conduct of the study, confound interpretation of the study results, or endanger their own well-being. The occurrence or continuation of any adverse event or condition during study 22001 that, in the opinion of the Investigator, should exclude the subject from participating in this open-label extension.

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 40 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 |
| --- | --- |
| Active Comparator: STX209<br> | Drug: Arbaclofen<br>* A flexible dose titration will be utilized during the first four weeks to define the optimal titrated dose (OTD) for each subject. Investigators will use clinical judgment to adjust doses to the OTD. The starting dose will be 1 mg BID. The dose may be increased every four to five days to 2 mg BID, 3 mg BID, 5 mg BID and then 10 mg BID<br>* Other names: STX209;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Irritability subscale of the Aberrant Behavior Checklist |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fragile X Syndrome
Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to assess the effect Of zoledronic acid on circulating and bone marrow-residing prostate cancer cells in patients with clinically localized prostate cancer

Official Title
-----------------
Effect Of Zoledronic Acid On Circulating And Bone Marrow-Residing Prostate Cancer Cells In Patients With Clinically Localized Prostate Cancer

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

Intervention / Treatment
-----------------
* Drug: Zoledronic acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Prostate cancer Radical prostatectomy or external beam irradiation therapy within 6 months before study entry. No bone metastases according to bone scan Exclusion Criteria Metastatic prostate cancer Hormone ablation therapy for more than 3 months before/after radical prostatectomy and external beam irradiation therapy Treatment with bisphosphonates or other drugs known to affect the skeleton within the past year. Other protocol-defined inclusion / exclusion criteria may apply.

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

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

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: Zoledronic acid<br>4 mg IV infused over 15 minutes every 3 months | Drug: Zoledronic acid<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the activity of one year treatment with zoledronic acid |  | 12 mos | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Three-year disease free survival |  | 3 years | 
| Change in bone mineral density at 12, 24 and 36 months versus baseline |  | 12, 24 and 36 months | 
| Changes in bone resorption markers at 12, 24 and 36 months versus baseline |  | 12, 24 and 36 months | 
| Safety and tolerability through abnormal values and AE reporting |  | upto 36 mos | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Prostate cancer, molecular staging, antitumor potential
Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Study Overview
=================
Brief Summary
-----------------
Radiation Plus Concurrent Nimotuzumab in Elderly Patients With Locoregionally Advanced Nasopharyngeal Carcinoma

Detailed Description
-----------------
Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week).

Conditions
-----------------
Nasopharyngeal Carcinoma

Intervention / Treatment
-----------------
* Drug: Nimotuzumab
* Radiation: Radiation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previously untreated and histologically confirmed locoregionally advanced nasopharyngeal carcinoma Exclusion Criteria: A history of another invasive cancer, prior RT to the head and neck area, prior cytotoxic chemotherapy or anti-EGFR therapy or the presence of any serious medical conditions, supposed to live less than 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Nimotuzumab<br>Elderly patients with locoregionally advanced nasopharyngeal carcinoma were given an initial dose of nimotuzumab (200 mg) 7days before receiving concurrent radiotherapy, weekly nimotuzumab (200 mg/week). | Drug: Nimotuzumab<br> <br> Radiation: Radiation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Toxicity was graded according to the National Cancer Institute-Common Toxicity Criteria for Adverse Events version 3.0. | Safety | an average of 3 months |
PSIL201 Long-term Follow-up Study: Psilocybin or Niacin / Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
This is a Phase 2 double-blind, long-term observational follow-up study of participants from Study PSIL201. Participants providing informed consent will be enrolled into this study and will complete web surveys and telephone interviews conducted by one central site at the following time intervals: months 2, 3, 4, 5 and 6 (± 7 days for each assessment) and months 8, 10, 12, 14, 16, 18, 20, 22 and 24 (± 14 days for each assessment).

Official Title
-----------------
A Two-Year Observational Follow-up Study of Subjects With Major Depressive Disorder Following a Randomized, Double-Blind Single-Dose of Psilocybin or Niacin-Control

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

Intervention / Treatment
-----------------
* Other: No intervention will be administered as part of this study.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrollment and intervention with the investigational drug in Study PSIL201 Exclusion Criteria: Inability or unwillingness to complete study procedures, including regular completion of web surveys and telephone interviews with study personnel

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 65 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 |
| --- | --- |
| Single-Dose of Psilocybin<br> | Other: No intervention will be administered as part of this study.<br>* No intervention will be administered as part of this study.<br>|
| Niacin-Control<br> | Other: No intervention will be administered as part of this study.<br>* No intervention will be administered as part of this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Asberg Depression Rating Scale | Between-group difference in mean change from baseline (prior to dosing in PSIL201) in Montgomery-Asberg Depression Rating Scale (MADRS) | 6 Months post-dosing in PSIL201 |
What Are the Predictive Factors for Preeclampsia in Oocyte Recipients? - PREROVE

Study Overview
=================
Brief Summary
-----------------
The main goal is to determine which risk factors develop preeclampsia in this specific group of oocyte recipients.

Official Title
-----------------
What Are the Predictive Factors for Preeclampsia in Oocyte Recipients? - PREROVE

Conditions
-----------------
Pregnancy, Oocyte Donation

Intervention / Treatment
-----------------
* Other: preeclampsia


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All major patients with a pregnancy of more than 22 weeks of amenorrhea resulting from an oocyte donation in one of the study centers, having given birth between January 2010 and April 2017 and not opposed to participation in the study. Exclusion Criteria: all pregnancies resulting from an oocyte donation abroad, persons of legal age subject to legal protection (safeguard of justice, guardianship, tutorship) and persons deprived of their liberty.

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: preeclampsia|occurrence of pre-eclampsia|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of pre-eclampsia |  | through study completion, an average of 1 year |
Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate

Study Overview
=================
Brief Summary
-----------------
comparison of holmium laser enucleation prostatectomy and open prostatectomy regarding safety and efficacy in men with prostate larger than 80 grams

Official Title
-----------------
Comparison of Holmium Laser Enucleation Prostatectomy and Open Transvesical Prostatectomy in Large Prostate More Than 80 Grams in Egyptian Men

Conditions
-----------------
Benign Prostatic Hyperplasia

Intervention / Treatment
-----------------
* Procedure: Holep


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Urological Association Symptom Score of eight or higher, Maximum urinary flow rate of 10ml/s or less, Post void residual urine volume of 50 ml or more, And a total prostate volume of 80 ml or more in transrectal ultrasound (TRUS). Exclusion Criteria: A previous prostate or urethral surgery And non-BPH related voiding disorders Prostate cancer patients

Ages Eligible for Study
-----------------
Minimum Age: 55 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
Interventional Model Description: randomized controlled trial
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Holep<br>patient underwent laser prostatectomy | Procedure: Holep<br>* laser enucleation of the gland versus open enucleation<br>* Other names: open prostatectomy;|
| Active Comparator: open prostatectomy<br>patient underwent open prostatectomy | Procedure: Holep<br>* laser enucleation of the gland versus open enucleation<br>* Other names: open prostatectomy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| efficacy by measuring maximum urinary flow rate in millilitre per second | change of maximum urinary flow rate in mililiter per second pre and post opeartive | 1 year | 
| efficacy in american urological association symptom score | change of american urological association symptom score pre and post operative by scale from 1 to 35 | 1 year | 
| efficacy of evacuation by measuring post-voiding residual urine volume in millilitre | change of post-voiding residual urine volume in millilitre | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety by doing blood picture to asses hemoglobin drop | rate of hemoglobin drop post-operatively by gram per decilitre | immediate post-operative |
Running Successful Journal Club

Study Overview
=================
Brief Summary
-----------------
Running successful journal club is of the important goals for postgraduate education.In this study, the effect of a 6-month interactive educational course on journal clubs of Mashhad Dental school was observed using a valid and reliable checklist(r=0.74). Data will be evaluated and compared using spss software by t-test.

Official Title
-----------------
Effect of Education on Running Successful Journal Club

Conditions
-----------------
Educational Course

Intervention / Treatment
-----------------
* Other: Education
* Other: Conventional


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Faculty members of Dental School,Postgraduate departments Exclusion Criteria: Faculty members of other schools,Undergraduate departments
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education<br>Departments passed 6-month interactive educational course | Other: Education<br>* A 6-month interactive course on critical appraisal<br>|
| No Intervention: No Education<br>Departments not passed 6-month interactive educational course | Other: Conventional<br>* Conventional method/no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| checklist mean score | The outcome mesures will be completed up to 6 months | up to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
journal club
Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study

Study Overview
=================
Brief Summary
-----------------
Acute renal failure is a frequent and severe postoperative complication of cardiac surgery performed under extracorporeal circulation. It is an independent risk factor for mortality and significantly increases the length of hospital stay. The origin of renal insufficiency after extracorporeal circulation is multifactorial (long duration of extracorporeal circulation, hemodynamic instability per and post-extracorporeal circulation, prolonged hypotension, transfusion ...). Nevertheless, an entirely different pathophysiological mechanism, though not recent, is less often mentioned but shows renewed interest. This is the concept of renal venous congestion which may be responsible for impaired renal function in the absence of cardiac dysfunction. Based on Guyton's circulatory model, the investigators approach this systemic venous hypertension through the measurement of the Pmsf-PVC gradient.

Official Title
-----------------
Postoperative Renal Failure in Cardiac Surgery PMSF-PVC Gradient Study

Conditions
-----------------
Scheduled Heart Surgery, Valve Replacement, Coronary Artery Bypass

Intervention / Treatment
-----------------
* Other: Pmsf-PVC gradient measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age> 18 years subject having signed an informed consent scheduled heart surgery: Valve replacement Coronary artery bypass Exclusion Criteria: Any urgent surgery or redux Severe preoperative chronic renal failure (stage III) defined by GFR <30ml / min Existence of rhythm disorders (permanent ACFA) or serious cardiac conduction disorders, patients with Pacemaker Preoperative alteration of left ventricular ejection fraction with LVEF <40% Major haemodynamic instability with refractory shock defined by dobutamine ≥10μg / kg / min and / or norepinephrine ≥ 1μg / kg / min and / or epinephrine ≥ 0.2μg / kg / min. Intra-aortic versus assisted pelvic balloon Contraindication to femoral arterial catheterization Subject under the protection of justice, subject under guardianship or under tutorship Impossibility of giving the subject informed information (subject in emergency situation, difficulties in understanding the subject)

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Pmsf-PVC gradient measurement|implementation of standard standard hemodynamic monitorin|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evolution of the gradient Pmsf (arm) -PVC | Monitor the evolution of the Pmsf (arm) -PVC gradient at H24 and compare this gradient between the two patient populations (with and without postoperative acute renal failure) | 24 hours |
Telephone Reminder to Increase Appointment Rates

Study Overview
=================
Brief Summary
-----------------
Missed appointments to outpatient substance use treatment are common and costly and can have a negative effect on the health of patients. In this quasi-experimental study, the investigators used an on-off design to examine whether a reminder plus intervention (telephone call from therapist before first appointment) would increase attendance and improve cancellation and rebooking practices. Secondary outcomes included satisfaction with treatment and intention to complete the treatment program.

Official Title
-----------------
Reducing the Rate of Missed Appointments in an Outpatient Substance Use Treatment Clinic in Norway

Conditions
-----------------
Reminder Systems, Substance-Related Disorders

Intervention / Treatment
-----------------
* Other: Reminder plus (telephone call from therapist)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Newly referred patient > 18 years Diagnosis: Substance related disorder Exclusion Criteria: Patients who are unable to understand or score the survey due to cognitive or language barriers

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: Quasi-experimental with an OFF-ON design
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: OFF intervention<br>No reminder plus (telephone reminder from therapist) but standard test message reminder (SMS) from second admission | |
| Experimental: ON intervention<br>Reminder plus (telephone reminder from therapist) AND standard test message reminder (SMS) from second admission | Other: Reminder plus (telephone call from therapist)<br>* Reminder plus (telephone call from therapist)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attendance rate | Attendance rate at first admission and during 10 outpatient sessions | Up to 10 treatment sessions, estimated average timeframe = 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dropout rate | Dropout rate within 10 sessions - measured as formal discharge and/or technical discharge (3x no-shows) | Up to 10 treatment sessions, estimated average timeframe = 3 months | 
| Cancellation / rebooking rate | Examine difference in cancellation / rebooking rate between the two conditions. Data was collected from administrative patient records. | Up to 10 treatment sessions, estimated average timeframe = 3 months |