linjc16/ctgov huggingface dataset:
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Monovalent Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age

Study Overview
=================
Brief Summary
-----------------
The goals of the proposed study are to evaluate the safety, tolerability and immunogenicity of a GBS vaccine. Previous studies suggest that immune responses against GBS can protect humans from infection.

Official Title
-----------------
A Phase I, Randomized, Single-blind, Controlled, Single Center Study to Evaluate the Safety and Immunogenicity of a Dose Range of a Glycoconjugate Antigen Vaccine of Group B Streptococcus in Healthy Women 18-40 Years of Age

Conditions
-----------------
Invasive Group B Streptococcus (GBS) Disease

Intervention / Treatment
-----------------
* Biological: Monovalent GBS-CRM glycoconjugate vaccine
* Biological: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy females 18 through 40 years of age; have provided written informed consent after the nature of the study has been explained; are available for all visits scheduled for the study (i.e. are not planning to leave the area before the end of the study period); are in good health as determined by: medical history, physical assessment, clinical judgment of the investigator Exclusion Criteria: unwilling or unable to give written informed consent to participate in the study; pregnant (serum pregnancy test) unwilling to use acceptable birth control from screening and until at least 3 months after the final immunization nursing (breastfeeding) mothers

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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Monovalent GBS-CRM glycoconjugate vaccine<br>* 1 dose of GBS conjugate vaccine<br>|
| Placebo Comparator: 2<br> | Biological: Placebo<br>* 1 dose of placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety and tolerability of an intramuscular GBS conjugate vaccine. Safety will be assessed by measuring the incidence of local and systemic reactogenicity, adverse events and serious adverse events. |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To study the magnitude and durability of GBS-specific antibody responses over 12 months. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GBS, GBS prevention
Improving Team Training During Mock Code Blue Simulations

Study Overview
=================
Brief Summary
-----------------
Communication and teamwork failures are the leading causes of errors in healthcare settings. In situ mock code simulations are a potential means to train team-based skills using simulation within real clinical care environments where errors occur; however, debriefing discussions often focus on gaps in learners' clinical skills as opposed to team functioning. This study aims to determine whether learners who are pre-trained using just-in-time simulation regarding CPR quality and medication administration will exhibit improved performance with respect to these skills during in situ mock codes as well as improved team functioning.

Official Title
-----------------
Improving the Quality of Team Training and Performance During Interprofessional in Situ Mock Code Blue Simulations: A Randomized Controlled Mixed-methods Study

Conditions
-----------------
Education, Simulation

Intervention / Treatment
-----------------
* Behavioral: Just-in-time training (JITT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Health professionals, including nurses, pediatric residents, physicians and/or respiratory therapists scheduled to participate in interprofessional, team-based in situ mock codes. 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Just-in-time training (JITT) group<br>Receive a 20min just-in-time simulation-based teaching session targeting: (1) CPR quality and (2) medication administration within 3 hours of the scheduled in situ simulation. | Behavioral: Just-in-time training (JITT)<br>* The JITT training is a 20 minute simulation-based teaching session targeting: (1) CPR quality and (2) medication administration.<br>|
| No Intervention: No additional training (control) group<br>Control group who receives no additional training. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Team-based non-technical skills | Measured using the Team Emergency Assessment Measure (TEAM) scale | Time Frame: All data will be collected during the one hour when participants engage in the in situ mock code simulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPR quality | Measured using the Zoll R series defibrillator (compressions per minute (cpm), depth in millimeters (mm), and compression fraction) | Time Frame: All data will be collected during the one hour when participants engage in the in situ mock code simulation |
Incisions for Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose is to evaluate the investigators' length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs. These data will lead to a new minimally invasive standard of care without a reduction in outcomes.

Detailed Description
-----------------
There is a trend in surgery, in general, toward minimal invasion. This includes the transition to laparoscopy/thoracoscopy from open procedures, as well as the reduction in incision size for open procedures. The goal of minimally invasive techniques is to reduce morbidity and length of hospital stay, with a consequent reduction in hospital cost. There are few cardiac operations that are currently performed with minimally invasive techniques. One of these is the repair of an atrial septal defect, which can be performed though a small skin incision and partial rather than full sternotomy. Another is the ligation of a patent ductus arteriosus, which can be performed through a muscle-sparing thoracotomy rather than a full thoracotomy. Both of these techniques minimize the scarring and the healing time required for post-operative recovery. We need to be confident that it has not affected our outcomes adversely. We need to evaluate our length of incisions based on patient weight, operative times, hospital lengths of stay, pain medicine requirements, complications and costs. Hopefully, these data will lead to a new minimally invasive standard of care without a reduction in outcomes. We will review charts before November 1, 2004 at Children's Healthcare of Atlanta.

Official Title
-----------------
Small Incisions for Cardiac Surgery

Conditions
-----------------
Cardiac Surgery, Cardiac Diseases

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children who have undergone cardiac surgery at Children's Healthcare of Atlanta Surgery before November 1, 2004 Exclusion Criteria; those who do not fall under the above inclusion criteria
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
-----------------
pediatric health, cardiac, small incisions, operations, minimally invasive
Cross-cultural Adaptation and Validation in Moroccan Arabic Dialect Darija of the QoR-15 Postoperative Recovery Quality Score

Study Overview
=================
Brief Summary
-----------------
The QoR-15 Is a post operative recovery score developed in 2013 from the QoR-40 with an advantage of simplification. The investigators Aim to translate and to validate a such useful score in Arabic adapted for Morocco by a full psychometric evaluation of the Arabic version, by testing its validity, reliability, responsiveness, and clinical acceptability and feasibility, with patients undergoing abdominal, thoracic, gynecological surgery, or digestive endoscopy in the National Institute of Oncology of Rabat, affiliated to Mohammed V University in Rabat, Morocco.

Official Title
-----------------
Cross-cultural Adaptation and Validation in Moroccan Arabic Dialect Darija of the QoR-15 Postoperative Recovery Quality Score

Conditions
-----------------
Recovery of Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years Agreement in writing for the use of the data Exclusion Criteria: Patients who expressed their refusal to participate in the study Patients unable to express their non-opposition to participating in the study Patients operated on for surgery for which it was highly probable that it would not be possible for them to answer the questionnaire postoperatively (first 24 hours) Patients who do not master the Arabic language, neither read nor spoken

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Postoperative Quality of Recovery 15 in Moroccan Arabic scale (QoR-15 MA) functional recovery score at recovery from anesthesia |  | One Hour after recovery from anesthesia | 
| The differential between the QoR-15MA score preoperatively and postoperatively | Change from preoperative baseline of QoR-15MA to postoperative scale at one hour after recovery from anesthesia | Day 1 |
Evaluation of the QuantiFERON-TB Test.

Study Overview
=================
Brief Summary
-----------------
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.

Detailed Description
-----------------
To compare the sensitivity of the CST001 assay to the QuantiFERON-TB Gold assay in patients with bacteriologically confirmed and untreated TB disease.

Official Title
-----------------
Evaluation of the 4th Generation QuantiFERON-TB Test (CST001) for the Detection of Tuberculosis Infection

Conditions
-----------------
Tuberculosis

Intervention / Treatment
-----------------
* Device: CST001


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical symptoms consistent with a high probability of having TB disease Receiving, or are likely to receive, therapy for active TB Confirmed tuberculosis by either AFB smear and culture testing, or Nucleic Acid Amplification methods and culture testing. Between 18 and 70 years of age. Exclusion Criteria: Taken therapy for active TB or latent TB for more than 14 days Culture confirmation of M. tuberculosis not obtained

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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Symptomatic<br>Patients with bacteriologically confirmed and untreated TB disease tested with CST001 assay. | Device: CST001<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Signs/Symptoms Indicating TB With a Positive CST001 Assay Result as an Indication of Clinical Sensitivity | Subjects who have clinical signs/symptoms indicating TB and who are receiving or have to start the treatment for active TB were tested. Subjects who were presenting with symptoms suggestive of TB disease and who have a positive acid-fast bacillus (AFB) smear or have Mycobacterium tuberculosis (MTB) in a specimen detected by nucleic acid amplification (NAA) or MTB complex Polymerase Chain Reaction (PCR), and who have received treatment for no more than 14 days upon enrollment. | At time of enrollment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TB, Tuberculosis
Effect of Two Exercise Programs on Obese Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare the effectiveness of two exercise programs (High Intensity Interval Training/HIIT and Low Intensity (LIT) Long Duration training) on decreasing fat mass and preserving lean body mass in obese patients. What the investigators are proposing is that HIIT is less effective because it will most likely decrease lean body mass in obese patients, whereas LIT decreases fat mass and conserves lean body tissue.

Official Title
-----------------
Effect of HIIT vs Low Intensity Training on Fat Loss in Obese Patients

Conditions
-----------------
Obesity, Hypertension

Intervention / Treatment
-----------------
* Other: Exercise Type


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anyone with a BMI of 25 and above Exclusion Criteria: Those that cannot exercise

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 89 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Interventional Model Description: This is a case/control study comparing overweight/obese patients of three different groups (control, HIIT, LIT). The goal of a case/control is to show whether exposure to HIIT, two times a week for 6 weeks will decrease lean body mass versus control and LIT. If it turns out that lean body mass does decrease, then HIIT is not an effective exercise modality for overweight/obese patients, and in fact LIT or control may be a better option.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: HIIT (High Intensity Interval Training)<br>Subjects are undergoing high intensity interval training | Other: Exercise Type<br>* The implementation of 2 types of exercise programs to reduce body fat<br>|
| Active Comparator: Low intensity training long duration<br>Subjects are undergoing a lower intensity training program for a long duration | Other: Exercise Type<br>* The implementation of 2 types of exercise programs to reduce body fat<br>|
| No Intervention: Control<br>No exercise program intervention (usual care) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body fat | Reduction in body fat | 6 weeks | 
| Lean body mass | Retention of lean body mass | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure | Reduction of blood pressure | 6 weeks |
Effect of Dexmedetomidine on Pacemaker Function Following Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
This is a prospective study looking at the effects of dexmedetomidine on pacemaker function in patients who have surgery for congenital heart disease utilizing cardiopulmonary bypass (CBP). For the purpose of the study, no change in intraoperative care will be dictated. The use of dexmedetomidine will be left up to the discretion of the treating physicians. The study will involve only the collection of data regarding the amplitude required to capture and specific demographics and intraoperative features including cross clamp time, time on CPB, and vasoactive agents that were and are being administered. In addition to these data, it will be noted whether dexmedetomdine was used or not and whether it is being administered on arrival to the CTICU.

Conditions
-----------------
Congenital Heart Disease

Intervention / Treatment
-----------------
* Drug: Dexmedetomidine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with temporary surface pacemaker leads following surgery for congenital heart disease. Exclusion Criteria: Patients with single ventricle anatomy Patients receiving epinephrine Infants less than 6 months of age

Ages Eligible for Study
-----------------
Minimum Age: 6 Months

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dexmedetomidine<br>Patients that received dexmedetomidine during open heart surgery. | Drug: Dexmedetomidine<br> <br> * Other names: Precedex;|
| No dexmedetomidine<br>Patients that didn't receive dexmedetomidine during open heart surgery. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Amplitude | The impulse required to elicit atrial or ventricle capture (contraction) of the surface electrode of a temporary postoperative pacemaker. | Baseline |
Enterotomy Closure and Minimally Invasive Gastrectomy

Study Overview
=================
Brief Summary
-----------------
All consecutive patients from January 2009 to december 2019 who underwent minimally invasive partial gastrectomy for gastric cancer at thirteen high volume institutions will be retrospective analysed to assess the better way to fashion a handsewn intracorporeal enterotomy closure after a stapled anastomosis.

Detailed Description
-----------------
Different ways to fashion intracorporeal anstomoses will be investigated: robotic vs laparoscopic approach; laparoscopic HD vs 3D vs 4K technologies; single layer vs double layer enterotomy closure. Additionally double layer enterotomies will be analysed layer by layer, comparing running vs interrupted suture, presence vs absence of deep corner suture and type of suture thread (barbed, braided, non braided suture)

Official Title
-----------------
Enterotomy Closure After Minimally Invasive Distal Gastrectomy With Intracorporeal Anastomosis.

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

Intervention / Treatment
-----------------
* Procedure: Totally intracorporeal distal gastrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years laparoscopic or robotic partial gastrectomy for gastric cancer Roux en Y or Billroth II reconstruction Exclusion Criteria: Age < 18 years open gastrectomy total gastrectomy Billroth I reconstruction

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 |
| --- | --- |
| Totally intracorporeal distal gastrectomy<br>All patients who underwent minimally invasive distal gastrectomy with intracorporeal anastomosis for gastric cancer | Procedure: Totally intracorporeal distal gastrectomy<br>* Minimally invasive distal gastrectomy with intracorporeal anastomosis and handsewn enterotomy closure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative complications | The better way to fashion enterotomy closure | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intracorporeal gastrectomy, enterotomy closure
Effect of PEEP on Lung Regional Ventilation and Perfusion

Study Overview
=================
Brief Summary
-----------------
Investigate effects of PEEP on pulmonary regional ventilation and perfusion assessed by EIT

Detailed Description
-----------------
When the research team was available, adult patients within 7days who were sequentially admitted to the Department of Critical Care Medicine and required central venous catheters and mechanically ventilation were eligible for the study. Written informed consent was obtained from all patients or next of kin before data were included in the study. Information collected at enrollment included demographic characteristics, such as age, sex. The blood pressure（BP）,heart rate（HR）, pulse O2（SpO2）,tidal volume and lung regional ventilation and perfusion were collected at PEEP 0 centimeter H2O column and PEEP 12-15 centimeter H2O column. Indicator-based EIT method: rapidly inject 10ml 10% Sodium chloride（NaCL） through central venous catheter during a 8s respiratory hold, and the curve of impedence change was collected by EIT machine

Official Title
-----------------
Effect of Positive End-expiratory Pressure(PEEP) on Regional Ventilation and Perfusion Estimated by Indicator-based Electrical Impedance Tomography(EIT) Method in Critically Ill Patients With Mechanical Ventilation

Conditions
-----------------
Mechanical Ventilation Complication, Respiratory Failure, Hypoxia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: have been placed central venous catheter based on patient's condition Under mechanically ventilation Under sedation and control ventilation mode Year>18 Exclusion Criteria: Pneumothorax pregnancy Severe chest wall wound Severe hypernatremia

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| lung regional ventilation distribution | lung regional ventilation distribution measured by EIT | Hour 1 | 
| lung regional perfusion distribution | lung regional perfusion distribution measured by EIT | Hour 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EIT, pulmonary perfusion, ventilation