linjc16/ctgov huggingface dataset:
3D Breast Ultrasound Elastography in Patients Under Neoadjuvant Chemotherapy

Study Overview
=================
Brief Summary
-----------------
Breast Ultrasound Elastography is a complementary technique permitting a better characterization of breast lesions. 3D breast ultrasound elastography is a novel technique permitting a volumetric calculation of lesion stiffness. This could be particularly useful in patients with large breast tumors under pre-operative chemotherapy

Detailed Description
-----------------
3D breast ultrasound elastography provides volumetric lesion stiffness details in real time. 3D acquisition is compared to breast MRI in order to evaluate volume measurements calculated in ultrasound. Lesion elasticity is calculated in 3 planes with immediate reconstruction. The purpose of this prospective study is to evaluate the feasibility of this technique and compare the results to those of Breast MRI. For women receiving preoperative chemotherapy, this technique will be evaluated with regard to tumour shrinkage and lesion elasticity modifications under treatment.

Official Title
-----------------
Imagerie 3D d'élasticité du Sein Par échographie Ultrarapide au Cours d'un Traitement Par chimiothérapie néoadjuvante.

Conditions
-----------------
Malignant Breast Tumours

Intervention / Treatment
-----------------
* Device: 3D Ultrasound elastography by means of shear wave propagation into breast tissue


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients having already undergone a breast MRI Patients presenting with breast lesions measuring between20-50mm in ultrasound Exclusion Criteria: Multifocal lesions History of breast cancer Breast implants Inflammatory breast disease Pregnancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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: shear wave imaging<br>Single arm study evaluating breast 3D elastography by means of shear wave propagation into breast tissue. | Device: 3D Ultrasound elastography by means of shear wave propagation into breast tissue<br>* Aixplorer Supersonic Imagine Ultrasound System with 3D probe for real-time elastography<br>* Other names: Aixplorer Supersonic Imagine;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3D volumetric elasticity measurements | An utrafast shear wave imaging 3-plane acquisition provides several frames of breast lesion elasticity, that are reconstructed by means of a dedicated software thus permitting the direct volumetric elasticity measurements in kPa | 10min |
The Application of Neck Ultrasound in the Assessment of Peripherally Inserted Central Catheter (PICC) Tip Position

Study Overview
=================
Brief Summary
-----------------
Insertion of peripherally inserted central catheters (PICCs) at the bedside may result in tip malposition. This study was designed to evaluate whether the addition of ultrasound (US) inspection of the ipsilateral neck provides immediate recognition of PICCs in aberrant position facilitating catheter reposition prior to completion of the procedure.

Official Title
-----------------
A Randomized, Controlled Trial Evaluating Post-Insertion Neck Ultrasound in Peripherally Inserted Central Catheter Procedures

Conditions
-----------------
Peripherally Inserted Central Catheter Insertion Technique

Intervention / Treatment
-----------------
* Other: Ultrasound inspection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (> 18 years old) ordered for a peripherally inserted central catheter insertion Exclusion Criteria: patients unable to provide informed consent previous peripheral inserted central catheter placement at the institution

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1 - Neck Ultrasound<br>post-PICC insertion ultrasound inspection of the ipsilateral neck | Other: Ultrasound inspection<br>* post-PICC insertion Ultrasound inspection of the ipsilateral neck for PICC in a malposition (ipsilateral internal jugular vein)<br>|
| No Intervention: 2 - Control<br>No post-PICC insertion ultrasound inspection of the ipsilateral neck | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of PICCs in the ipsilateral internal jugular vein malposition as detected by post-procedure chest x-ray |  | Same day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of PICC procedure. |  | Same day. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Catheter, Peripherally inserted central catheter, ultrasound, malposition
Blood Test Order and Culture Contamination

Study Overview
=================
Brief Summary
-----------------
A randomized partially controlled study to examine the effect of blood diversion into a heparin lithium tube on the incidence of blood culture contamination.

Official Title
-----------------
A Randomized Controlled Study of Blood Test Draw Order to Reduce Blood Culture Contamination

Conditions
-----------------
Blood Culture Contamination

Intervention / Treatment
-----------------
* Other: Blood diversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Presence in Emergency Room during extended office hours (0800-2000 on weekdays( Clinical requirement for Blood culture and biochemistry tests from venepuncture Exclusion Criteria: None

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective partially blinded randomized study
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Group<br>Blood culture obtained as first test after venipuncture and prior to biochemistry test | |
| Experimental: Diversion Group<br>Biochemistry test obtained as first test after venepuncture and prior to blood culture | Other: Blood diversion<br>* Diversion of initial blood obtained at venipuncture to biochemistry tube in order to try and reduce incidence of blood culture contamination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood culture contamination | Growth of bacteria defined as blood culture contaminants (for example coagulase negative staphylococci in one bottle only). | up to 7 days from obtaining blood culture | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient length of stay | Length of stay from arrival at Emergency room until discharge in hours | up to 3 months from arrival |
Yoga Intervention for Substance Use and ART Adherence in Community Reentry

Study Overview
=================
Brief Summary
-----------------
People with HIV and a substance use disorder who are reentering the community from prison or jail face the dual risks of relapse and interruptions in adherence to antiretroviral therapy (ART) medication. This mixed-methods randomized controlled trial will compare the stress, substance use and ART adherence outcomes of participants in a 12-session, 90-minute weekly yoga group intervention with participants in a treatment as usual control group. All participants are re-entering the community, have HIV and experience substance use challenges.

Official Title
-----------------
Yoga Intervention for Substance Use and Antiretroviral Therapy Adherence in Community

Conditions
-----------------
Substance Related Disorders, HIV

Intervention / Treatment
-----------------
* Other: Hatha yoga


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have HIV experience substance use challenges, within one year of reentry from prison or jail

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hatha Yoga<br>A 12-session 90-minute weekly hatha yoga intervention, that includes asanas (physical postures), pranayama (breathing exercises) and dhyana (meditation. | Other: Hatha yoga<br> <br> |
| No Intervention: Treatment as Usual<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stress: Perceived Stress Scale (self-report) |  | 3 months | 
| Substance use: Time Line Follow Back (self-report) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiretroviral therapy adherence: prescription refill (pharmacy data) |  | 3 months | 
| Heart rate: sphygmomanometer |  | 3 months | 
| Blood pressure: sphygmomanometer |  | 3 months | 
| Viral load: blood test |  | 3 months |
ALK37-005: A Study of ALKS 37 (RDC-1036) in Adults With Opioid-induced Constipation (OIC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety, tolerability and efficacy of ALKS 37 when administered daily for 4 weeks to adults with Opioid-induced Constipation (OIC).

Official Title
-----------------
A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose Study to Evaluate the Safety, Tolerability, and Efficacy of ALKS 37 in Subjects With Opioid-induced Constipation

Conditions
-----------------
Opioid-induced Constipation

Intervention / Treatment
-----------------
* Drug: ALKS 37
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Are at least 18 years of age at time of consent Have a body mass index (BMI)of 19 to 35 kg/m2 at screening Are receiving prescribed opioid medication for the management of chronic, non-cancer pain Meet the criteria of OIC Agree to use an acceptable method of contraception for the duration of the study Exclusion Criteria: Pregnancy and/or currently breastfeeding Clinically significant medical condition or illness (other than the condition for which the pain medication is being prescribed) Receiving treatment with opioid therapy for cancer-related pain, abdominal pain, scleroderma, and/or for the management of drug addiction Any gastrointestinal (GI) disorder (other than opioid-induced constipation) or GI structural abnormality known to affect bowel transit, produce GI obstruction, or contribute to bowel dysfunction Use of naloxone, Subutex or Suboxone, Revia, Relistor, or Entereg starting 15 days before the first study visit following screening until the end of the study Participation in a clinical trial of a pharmacological agent within 30 days before screening

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>Capsules for oral administration | Drug: Placebo<br>* Capsules for oral administration<br>|
| Experimental: ALKS 37<br>Capsules for oral administration | Drug: ALKS 37<br>* Capsules for oral administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose response relationship among five doses of study drug (4 doses of ALKS 37 and placebo), defined as an increasing proportion of patients exhibiting overall response. | Overall response will be defined using an algorithm that takes into consideration number of complete spontaneous bowel movements, improvement from baseline, and durability of response. | 4 weeks |
Early Prediction of Fluoxetine Response

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to identify what degree of symptom changes during the early weeks could be used to predict eventual nonresponse at week 6 among depressive inpatients taking fluoxetine.

Detailed Description
-----------------
Patients with major depressive disorder will receive 20 mg/day of fluoxetine for six weeks. Symptom severity was assessed by the 17-item Hamilton Depression Rating Scale (HAMD-17) at weeks 0, 1, 2, 3, 4 and 6. Stable response is defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment. Receiver operating characteristic curve will be used to determine the cutoff point of the percentage of HAMD-17 score reduction between stable responders and nonresponders at weeks 1, 2, 3 and 4.

Official Title
-----------------
Model for Early Prediction of Clinical Response in Patients With Major Depression Receiving Fluoxetine

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

Intervention / Treatment
-----------------
* Drug: fluoxetine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of major depressive disorder HAM-D-17 ≧17 written informed consent Exclusion Criteria: Comorbid of substance abuse/dependence Comorbid with mental disorders due to general medical conditions Past history of treatment-resistant depression Severe physical problems pregnant women lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: fluoxetine<br> | Drug: fluoxetine<br>* fluoxetine 20 mg/d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Stable response was defined as a reduction of 50% or more of the HAMD-17 score at week 4 and week 6 of treatment |  | 6 weeks after initiation of fluxetine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CGI, GAF, Zung's Depression Scale, Short-Form 36, auditory evoked potential, psychomotor speed |  | 6 weeks after initiation of fluxetine | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
major depressive disorder, fluoxetine, Hamilton Rating Scale for Depression (HAM-D-17)
Feasibility of Microdialysis by Laparoscopy

Study Overview
=================
Brief Summary
-----------------
The aim of this pilot study is to evaluate the feasibility of microdialysis by laparoscopy in order to identify anastomotic leaks after rectal surgery.

Official Title
-----------------
Feasibility of Microdialysis by Laparoscopy

Conditions
-----------------
Rectal Cancer

Intervention / Treatment
-----------------
* Device: cma microdialysis catheter placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: rectal disease requiring proctectomy with anastomosis and stomy proctectomy by laparoscopy written consent Exclusion Criteria: history of colorectal surgery rectal surgery without anastomosis breastfeeding or pregnancy ASA score IV

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: cma microdialysis catheter placement<br>At the end of the surgery the cma microdialysis catheter is placed near the anastomosis | Device: cma microdialysis catheter placement<br>* the microdialysis catheters are sold by CMA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| functional success of microdialysis | the functional success of microdialysis is defined as abnormal values localised at the microdialysis catheter | postoperative day 5 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anastomotic leaks rate | the anastomotic leaks rate is defined as the number of anastomotic leaks validated by a CT scan | postoperative day 30 | 
| superficial surgical site infection rate | the surgical site infection rate is defined as the number of infection near the incision | postoperative day 30 | 
| the mortality rate | the mortality rate is defined as the number of death after the surgery | postoperative day 30 | 
| the quality of life after the surgery | the quality of life will be evaluated with the QLQ C30 CR 29 prior to the surgery, at the hospital discharge and on postoperative day 30 | postoperative day 30 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
rectum, microdialysis, quality of life
Supreme LMA and Proseal LMA in Prone Anesthetized Patient

Study Overview
=================
Brief Summary
-----------------
There is no significant difference about success rate of two devices.

Detailed Description
-----------------
There is no significant difference about success rate of two device: efficacy and safety

Official Title
-----------------
Comparison of the Effectiveness Between the LMA SupremeTM and the LMA ProsealTM for Airway Management in Patient Undergoing Elective Orthopaedic Surgery in Prone Position

Conditions
-----------------
Inadequate or Impaired Breathing Pattern or Ventilation

Intervention / Treatment
-----------------
* Device: Supreme LMA
* Device: Proseal LMA


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society Anesthesiologists physical status I-III Patient undergo elective orthopedics surgery in prone position under general anaesthesia Exclusion Criteria: Age <15year Non-fast Morbid obesity (BMI > 35kg/m2) Pregnancy Known or predicted difficult airway GERD History of laryngeal problem (injury,subglottic stenosis) Local pharyngeal problem (abscess,tumor) Poor dentation Pulmonary disease

Ages Eligible for Study
-----------------
Maximum Age: 15 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Supreme<br>Supreme LMA | Device: Supreme LMA<br>* Use Supreme LMA to compare efficay with Proseal LMA in prone position insertion<br>|
| Active Comparator: Proseal<br>Proseal LMA | Device: Proseal LMA<br>* Use Proseal LMA to compare efficay with Supreme LMA in prone position insertion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success rate of insertion (quality of ventilation) |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ease of insertion, Complication and Glottic seal pressure |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
LMA Supreme,LMA Proseal,airway management,prone position
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016

Study Overview
=================
Brief Summary
-----------------
This is a single ascending dose study of HSD-016 to provide the initial assessment of the safety, tolerability, how the drug is absorbed and eliminated, and its effect on the body.

Official Title
-----------------
Single Ascending Dose Study of the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of HSD-016 Administered Orally to Healthy Subjects

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Drug: HSD-016
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Men or women of nonchildbearing potential aged 18 to 50 years inclusive at screening. Healthy as determined by the investigator on the basis of screening evaluations. Nonsmoker or smoker of fewer than 10 cigarettes per day as determined by history. Exclusion: No presence or history of any disorder that may prevent the successful completion of the study. No history of drug abuse within 1 year.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>Active | Drug: HSD-016<br> <br> |
| Placebo Comparator: Placebo<br>Placebo | Other: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Profiles of Drug Concentrations |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety and tolerability of HSD-016