linjc16/ctgov huggingface dataset:
Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients

Study Overview
=================
Brief Summary
-----------------
Several studies have shown a great potential of 68Ga-PSMA PET in high risk prostate cancers patients and a high detection rate than 18F-Choline PET. The primary aim of this study is to evaluate the difference of management intent, after the inital staging of high risk prostate cancer patients, with 68Ga-PSMA-11 PET-CT results in comparison of 18F-Choline PET-CT results.

Official Title
-----------------
Place of 68Ga-PSMA-11 PET-CT in the Therapeutic Decision at the End of the Initial Staging for High Risk Prostate Cancer Patients in Comparaison of 18F-Choline PET-CT

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

Intervention / Treatment
-----------------
* Diagnostic Test: 68Ga-PSMA-11
* Diagnostic Test: 18F-Choline PET-CT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: high risk prostate cancer patients with initial tests : CT, bone scintigraphy and 18F-Choline Exclusion Criteria: contraindication of 68Ga-PSMA PET-CT

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
Intervention Model: Single Group Assignment
Interventional Model Description: Each patient will realize a 18F-Choline PET/CT then a 68Ga-PSMA-11 PET/CT
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-PSMA PET-CT<br> | Diagnostic Test: 68Ga-PSMA-11<br>* radioactive tracer for PET-CT (68Ga-PSMA-11)<br>Diagnostic Test: 18F-Choline PET-CT<br>* radioactive tracer for PET-CT (18F-Choline PET-CT)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of modification of management intent | modification of management intent after 68Ga-PSMA PET-CT and 18F-Choline PET-CT | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
68Ga-PSMA PET
Liver Stiffness Measurement in Alcohol-dependent Subjects in Relation to Abstinence After Withdrawal

Study Overview
=================
Brief Summary
-----------------
This study is complementary to the main study Brain Derived Neurotrophic Factor Serum Levels Evolution During the Six Months After Alcohol Withdrawal  NCT01491347. Liver stiffness variation is one of the major somatic effect of chronic alcohol consumption. It is a consequence of numerous mechanisms, including inflammation. Liver stiffness seems to depend on alcohol consumption in alcohol dependent patient, more precisely on the time after the last alcohol consumption. This is very few documented after alcohol withdrawal, and has never been explored during several months after withdrawal as a function of alcohol consumption and abstinence. Brain Derived neurotrophic Factor (BDNF) seems to play a major role in general homeostasis and also liver function. We propose here to analyse the serum BDNF levels variations after withdrawal according to liver stiffness levels and alcohol consumption status. We will also measure liver stiffness using Fibroscan® in alcohol dependent subjects included in the main study to search for a link with serum BDNF levels and abstinence at day 0, 14, 28 and months 2, 4, and 6.

Conditions
-----------------
Alcohol Withdrawal

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participation to the study BDNF serum levels evolution during 6 months after alcohol withdrawal (main study) criteria from the main study Exclusion Criteria: criteria from the main study

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| alcohol withdrawal<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BDNF serum levels as a function of stiffness categories in the abstinent and non abstinent groups at inclusion and at the different follow-ups of the study (M2, M4, M6) |  | 6 months maximum | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum BDNF levels variations between inclusion and M2, M2 and M4 and M4 and M6. |  | 6 months | 
| liver stiffness categories according to stiffness measurements at inclusion, M2, M4 and M6 |  | 6 months | 
| Variations in liver stiffness |  | 6 months | 
| controlled attenuation parameter (CAP) at each follow-up |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fibroscan, alcohol dependence, alcohol withdrawal, controlled attenuation parameter, BDNF
A Study of RX-10045 in the Treatment of Dry Eye Disease

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the efficacy, tolerability and safety of RX-10045 Ophthalmic Solution in patients with Dry Eye Disease.

Official Title
-----------------
A Phase II, Multi-Center, Randomized, Placebo-Controlled, Double-Masked Study of RX-10045 (0.09%) in the Treatment of Dry Eye Disease

Conditions
-----------------
Dry Eye Syndrome

Intervention / Treatment
-----------------
* Drug: RX-10045
* Drug: Vehicle for RX-10045


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Have a patient reported history of dry eye in both eyes Presence of dry eye symptoms Presence of dry eye signs, destabilized tear film break-up time and corneal staining Exclusion Criteria: Known contraindications or sensitivities to study medication or its components Any ocular condition that, in the opinion of the investigator, could affect the subject's safety or trial parameters Use of disallowed medication during the period indicated prior to the enrollment or during the study Be a female who is currently pregnant, planning a pregnancy, lactating, or not using a medically acceptable form of birth control

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RX-10045 active arm<br>RX-10045 Opththalmic Solution, 0.09% | Drug: RX-10045<br>* One drop of RX-10045 ophthalmic solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.<br>|
| Placebo Comparator: Vehicle for RX-10045 arm<br>Vehicle of RX-10045 Ophthalmic Solution | Drug: Vehicle for RX-10045<br>* One drop of RX-10045 placebo solution will be instilled in each eye, twice a day, approximately 12 hours apart for 28 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Corneal staining |  | Baseline to day 28 | 
| Worst symptom score |  | Baseline to day 28 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular discomfort symptom score |  | Baseline to day 28 | 
| Tear film break-up time |  | Baseline to day 28 | 
| Visual-related function subscale of Ocular Surface Disease Index score |  | Baseline to day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
RX-10045, Dry Eye Disease
Study of the Relationship Between Serum Adiponectin and Clinical Prognosis in Patients Undergoing Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the relationship between serum adiponectin and clinical prognosis in patients undergoing cardiac surgery.

Detailed Description
-----------------
Adiponectin, an adipose tissue derived protein, is an abundant protein hormone regulatory of numerous metabolic processes. Since its discovery, adiponectin has garnered considerable attention for its role in cardiovascular pathology. It has been shown to be a predictor of cardiovascular events in both the general population and patients undergoing cardiac surgery. In this study,we are planning to investigate the relationship between serum adiponectin and clinical prognosis in patients undergoing cardiac surgery.

Official Title
-----------------
Study of the Relationship Between Serum Adiponectin and Clinical Prognosis in Patients Undergoing Cardiac Surgery

Conditions
-----------------
Cardiac Surgery

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who had underwent cardiac surgery from July 2011 to August 2012 in xijing hospital. Exclusion Criteria: Nothing particular.
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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adiponectin, Prognosis, Cardiac Surgery
Review of Anaesthetic Practice in Orthognathic Surgery

Study Overview
=================
Brief Summary
-----------------
Orthognathic surgeries for maxillofacial deformities are commonly performed globally. However, they are associated with significant blood loss which can affect the surgical field and result in blood transfusion and its risks. We aim to review the different hypotensive anaesthetic practices for orthognathic surgeries, and their effects on intraoperative blood loss and transfusion requirements.

Official Title
-----------------
A Retrospective Review of Anaesthetic Practice and Intraoperative Blood Loss in Orthognathic Surgery in a Tertiary Hospital

Conditions
-----------------
Maxillofacial Abnormalities, Blood Pressure, Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients who were scheduled for orthognathic surgeries from January 2014 to March 2017 Exclusion Criteria: surgery was not done there were missing anaesthetic records
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Anaesthesia type<br>Inhalational anaesthesia without Remifentanil use Inhalational anaesthesia with Remifentanil use Total intravenous anaesthesia | |
| Blood pressure monitoring<br>Intraarterial line use Non-invasive blood pressure monitoring | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anaesthesia technique | Most common modality for anaesthesia maintenance | Perioperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure monitoring | If the use of IA line vs NIBP affected patient outcomes in terms of blood loss | Perioperative |
Examining the Effects of Art Therapy in Reducing Burnout in Healthcare Providers

Study Overview
=================
Brief Summary
-----------------
In this study, the investigators aim to examine the effects of art therapy in reducing burnout in healthcare providers. Using the Maslach Burnout Inventory Human Services Survey for Medical Personnel, the investigators will measure burnout in Medical University of South Carolina (MUSC) providers before and after the administration of a 4-week art therapy group.

Official Title
-----------------
Examining the Effects of Art Therapy in Reducing Burnout in Healthcare Using the Maslach Burnout Inventory

Conditions
-----------------
Burnout, Professional

Intervention / Treatment
-----------------
* Behavioral: Art Therapy Group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18 years or older Employed at MUSC as a healthcare provider Able and willing to participate in all 4 art therapy sessions Exclusion Criteria: Individual does not provide direct patient care at MUSC Individual works in the same department as the art therapist Inability or unwillingness of subject to give informed consent
Sexes Eligible for Study
-----------------
All

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

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: Art Therapy Group<br> | Behavioral: Art Therapy Group<br>* The art therapy intervention will be executed by the same Medical University of South Carolina (MUSC) board-certified art therapist for each group. The art therapist is a masters-level, licensed practitioner who has experience working in the healthcare system and treating providers. The same art therapy practices that are utilized in daily practice at MUSC will be employed in this study, with a focus on reducing burnout symptoms. Pilot testing of the intervention has been performed informally at MUSC with positive feedback reported by healthcare providers.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Burnout Symptoms | Measuring burnout symptoms utilizing the Maslach Burnout Inventory | At start of therapy sessions and 4 weeks after therapy sessions | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Art Therapy
The PreNAPS Study: FI, Nutrition, and Psychosocial Health Outcomes at Gulu Regional Referral Hospital

Study Overview
=================
Brief Summary
-----------------
The Prenatal Nutrition and Psychosocial Health Outcomes (PreNAPS) study was a two year collaboration between Gulu, Makarere, Cornell, and Tufts Universities. The PreNAPs study's primary goals were: a) to determine the differential impacts of food insecurity on gestational weight gain and prenatal depression, and b) to elucidate the mechanisms underlying the relationship between food insecurity and weight gain and/depression among HIV infected and HIV uninfected pregnant women in Gulu, Northern Uganda.

Official Title
-----------------
The PreNAPS Study: Food Insecurity, Prenatal Nutrition, and Psychosocial Health Outcomes Among HIV Infected and Uninfected Pregnant Women Attending ANC Services at Gulu Regional Referral Hospital

Conditions
-----------------
HIV, Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant women Known HIV status Receiving antiretroviral therapy (if HIV-infected) Attending antenatal care at Gulu Regional Referral Hospital >18 years of age Exclusion Criteria: Pregnant women <18 years of age Unknown HIV status Not receiving antiretroviral therapy (if HIV-infected) Not attending antenatal care at Gulu Regional Referral Hospital

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

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

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 |
| --- | --- | --- |
| Impacts of food insecurity (IFIAS) on gestational weight gain (kg) among pregnant women of mixed HIV status in Gulu, Uganda | Explore the underlying mechanisms and impacts of food insecurity (using the Individuals Food Insecurity Access Scale (IFIAS)) on gestational weight gain (kg) among pregnant women of mixed HIV status in Gulu, Uganda. | Approximately 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impacts of food insecurity on maternal depression among pregnant women of mixed HIV status in Gulu, Uganda. | Explore the underlying mechanisms and impacts of food insecurity on maternal depressive symptoms among pregnant women of mixed HIV status in Gulu, Uganda. | Approximately 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Food Insecurity, Nutrition
A New Drug for Benign Prostatic Hyperplasia (BPH) Compared With Placebo

Study Overview
=================
Brief Summary
-----------------
A new drug for benign prostatic hyperplasia is compared to placebo for to determine if it is safe and effective. The study lasts approximately 20 weeks.

Detailed Description
-----------------
This will be a multi-center, double-blind, placebo controlled, parallel, 12 week treatment trial in men with signs and symptoms of benign prostatic hyperplasia. the following procedures are utilized: physical exams, electrocardiograms, clinical laboratory tests, vital signs, the Internation Prostate Symptom Score, maximum urine flow rate, pharmacokinetics, adverse events, concomitant medications, quality of life, and compliance.

Official Title
-----------------
A Multi-Center, Randomized, Double-Blind, Placebo Controlled, Parallel Evaluation of the Efficacy and Safety of a New Drug in the Treatment of the Signs and Symptoms of Benign Prostatic Hyperplasia

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

Intervention / Treatment
-----------------
* Drug: Silodosin
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males in good general health and at least 50 years of age, with symptoms of moderate to severe BPH. Exclusion Criteria: Medical conditions that would confound the efficacy evaluation. Medical conditions in which it would be unsafe to use an alpha-blocker. The use of concomitant drugs that would confound the efficacy evaluation. The use of concomitant drugs that would be unsafe with this alpha-blocker.

Ages Eligible for Study
-----------------
Minimum Age: 50 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Silodosin<br>Silodosin 8 mg/Day with food | Drug: Silodosin<br>* 8 mg daily for 12 weeks<br>* Other names: Rapaflo;|
| Placebo Comparator: Placebo<br>Matching placebo capsule once daily with food | Other: Placebo<br>* One capsule daily for 12 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measuring Change From Baseline in International Prostate Symptom Score (IPSS) at 12 Weeks | International prostate symptom score: Measuring prostate signs and symptoms asociated with benign prostatic hyperplasia on a 0 to 35 scale; 0 best, 35 worst symptoms | Baseline and 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Maximum Urine Flow Rate (Qmax) at 12 Weeks |  | Baseline and 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign prostatic hyperplasia, alpha blocker
Optimum Platelet Inhibition After Coronary Bypass Surgery

Study Overview
=================
Brief Summary
-----------------
To investigate the effect of different dosages of aspirin on platelet aggregation and to determine the possible mechanisms of aspirin resistance, we intend to compare the effects of low, medium dose aspirin with clopidogrel (an alternative antiplatelet agent) in patients after coronary artery bypass surgery.

Official Title
-----------------
Optimum Platelet Inhibition After Coronary Artery Bypass Surgery: A Randomised Trial Comparing Platelet Aggregation Using Low, Medium Dose Aspirin and Clopidogrel

Conditions
-----------------
Ischemic Heart Disease

Intervention / Treatment
-----------------
* Drug: Aspirin, Clopidogrel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: We intend to invite patients aged 18 to 80 proceeding to primary elective coronary artery bypass surgery, able to give informed consent. Exclusion Criteria: Preoperative exclusion criteria: patients who are have not stopped aspirin 7 days prior to surgery patients on concomitant NSAIDS patients with a previous history platelet disorders, splenectomy or haematological disorders patients with aspirin induced asthma patients with any contraindications to aspirin (GI bleed) patients who are on any medication that may result in a serious drug interaction with aspirin (warfarin) Women of childbearing potential Patients of less than 18 years If informed consent cannot be obtained If for any reason the consultant surgeon or anaesthetist deems it to be appropriate Operative exclusion criteria: • Concomitant procedures Postoperative exclusion criteria: patients who receive platelet transfusion patients who receive NSAIDS requirement for intra aortic balloon pump support failure of extubation within 24 hours

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Aspirin, Clopidogrel|nan|

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

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