linjc16/ctgov huggingface dataset:
Safety of the EnvPro HIV Vaccine in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety of a new HIV vaccine. The vaccine in this study is mixed with a chemical called alum to improve the body's response to the vaccine. Healthy adults who are not infected with HIV may participate in the study.

Detailed Description
-----------------
EnvPro is a recombinant, purified envelope protein vaccine with an aluminum hydroxide (alum) adjuvant. Aluminum hydroxide is licensed as an adjuvant in other vaccines, such as the hepatitis B vaccine. This study will examine the safety and tolerability of EnvPro with alum adjuvant in healthy, HIV uninfected adults. All participants in this study will receive vaccine injections in the upper arm muscle. Participants will receive a second vaccine injection eight weeks after the first injection. Blood tests will be performed at study visits before the vaccine is given, during the eight weeks between injections, and at selected times for up to three years after the vaccine is given.

Official Title
-----------------
Evaluation of Tolerability and Safety of a Recombinant Purified HIV Envelope Vaccine

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Biological: EnvPro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV uninfected Normal medical history and physical exam Normal complete blood count Normal liver function Normal renal function Normal serum creatine phosphokinase (CPK) Availability for at least 1 year follow-up Exclusion Criteria: History of immunosuppressive illness, chronic illness, or use of any immunosuppressive medications Medical or psychiatric condition or occupational responsibilities which preclude compliance with the study Live attenuated vaccines within 60 days of study entry Use of experimental agents within 30 days of study entry

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: EnvPro|nan|

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
-----------------
HIV Preventive Vaccine, HIV Seronegativity, Protein
Open-label Multicenter Study to Evaluate the Efficacy of PLX-PAD for the Treatment of COVID-19

Study Overview
=================
Brief Summary
-----------------
This clinical trial will examine if a new treatment of Mesenchymal-like Adherent stromal Cells (called PLX-PAD) can help patients intubated and mechanically ventilated due to COVID-19 to recover more quickly with less complications.

Official Title
-----------------
A Randomized, Controlled, Multicenter, Parallel-Group Phase IIa Study to Evaluate the Efficacy and Safety of Intramuscular Injections of PLX-PAD for the Treatment of Severe COVID-19

Conditions
-----------------
COVID, ARDS

Intervention / Treatment
-----------------
* Biological: PLX-PAD


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Willing and able to provide written informed consent, or with a legal representative who can provide informed consent. Male or non-pregnant female adult 18-85 years of age at time of enrollment. Laboratory-confirmed SARS-CoV-2 infection as determined by PCR, in any specimen up to 21 days prior to randomization. Meets definition of ARDS according to Berlin criteria. Key Exclusion Criteria: Body weight under 55 kg (121 lbs) Serum creatinine level of over 1.5 mg/dL at time of randomization. Total Bilirubin ≥2 mg/dL at time of randomization. Known allergy to any of the following: dimethyl sulfoxide (DMSO), human serum albumin, bovine serum albumin. Stroke or acute myocardial infarction/unstable angina within 3 months prior to randomization. Chronic Obstructive Pulmonary disease GOLD stage above II.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PLX-PAD Treatment<br>PLX-PAD 300 million cells (20 million/mL) administered via 15 IM injections (1 mL each). Single administration in addition to best standard medical care. | Biological: PLX-PAD<br>* PLX-PAD - allogeneic ex-vivo expanded placental mesenchymal-like adherent stromal cells<br>|
| No Intervention: Control Group<br>Best standard medical care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of ventilator-free days |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 28 and 60 days | 
| Duration of mechanical ventilation |  | 28 and 60 days |
Utility of Ultrasonography During Internal Jugular Vein Catheterisation in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Central venous access may be essential in pediatric patients for fluid and a blood product administration, medication, parenteral nutrition, renal replacement therapy and hemodynamic monitoring. Obtaining central venous access in pediatric patients can be challenging, failure rates in pediatric patients range from 5% to 19% with reported complication rates from 2,5% to 22% The landmark technique has been standard approach for many years. In comparison with landmark method in pediatric patients the use of ultrasound is associated with an increased success rate decreased operative time, reduced number of cannulation attempts , and a decreased number of carotid artery punctures. We wanted to evaluate our success rate using ultrasound as a guidance during central vein insertion.

Conditions
-----------------
Number of Trials, Complication Rate

Intervention / Treatment
-----------------
* Procedure: internal jugular vein catheter placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients required internal jugular vein catheter Exclusion Criteria: aged smaller than 1 month

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 16 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 |
| --- | --- |
| internal jugular vein catheter<br>pediatric patients required internal jugular vein catheter | Procedure: internal jugular vein catheter placement<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| success rate |  | during anesthesia | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complication rate |  | during anesthesia |
When do School-aged Patients Return to School After ACL Surgery?

Study Overview
=================
Brief Summary
-----------------
We intend to survey school aged patients following ACL surgery on when they return to school. We will analyze independent variables to determine if any relationship exists that may influence the amount of time missed.

Detailed Description
-----------------
All patients undergoing ACL surgery who are enrolled in middle or high school will be recruited for study participation. Patients undergoing concomitant additional ligament surgery will be excluded. The only procedure will be to answer a short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them. This will occur at the patient's 2 week post-operative clinic visit. This clinic visit is a standard of care visit. Independent variables will be collected from the medical record and are all standard of care information routinely collected from this patient populations (age, sex, race, date of surgery, surgeon, sport played, grade, ACL surgery graft type, associated meniscal or chondral surgery, length of post-operative narcotic use, regional nerve block at the time of surgery, SANE score, IKDC score, brace used).

Official Title
-----------------
When do School-aged Patients Return to School After ACL Surgery?

Conditions
-----------------
ACL Reconstruction

Intervention / Treatment
-----------------
* Other: observe when return to school after surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACL reconstruction surgery currently enrolled in middle or high school (grades 6-12) Surgery occurs during the school year No concomitant additional ligament surgery (ie. PCL, MCL, LCL or MPFL) Exclusion Criteria: patient is home schooled or in non-traditional school setting (ie. school for special needs) concomitant additional ligament surgery surgery occurs outside of the school year or on a scheduled break from school

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: observe when return to school after surgery|Short written questionnaire asking when they returned to school and what accommodations, if any, the school made available for them|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| When return to school after surgery | days from surgery to return to school | 1-2 weeks post-operatively |
Preoperative Diet Before Sleeve Gastrectomy

Study Overview
=================
Brief Summary
-----------------
Patients undergoing sleeve gastrectomy aara randomized into 3 groups:preoperative regular diet , preoperative balanced energy high protein formula and Immunonutrition formula.Postoperative pain and acute phase reactants at 24hours after surgery are investigated.

Detailed Description
-----------------
Patients undergoing sleeve gastrectomy as bariatric procedure ara randomized into 3 groups: those patients receiving a preoperative regular diet of 900 Kcal/day (Group 1), those receiving preoperative balanced energy high protein formula (Group 2) and those receiving preoperative Immunonutrition formula (Group 3). Postoperative pain and acute phase reactants at 24hours after surgery are investigated.

Official Title
-----------------
Preoperative Regular Diet of 900 Kcal/Day vs Balanced Energy High Protein Formula vs Immunonutrition Formula: Effect on Postoperative Pain After Laparoscopic Sleeve Gastrectomy

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Dietary Supplement: Regular diet
* Dietary Supplement: High protein formula
* Dietary Supplement: Immunonutrition


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI >40 Kg/m2 BMI > 35 Kg/m2 with the presence of comorbidities associated to obesity Exclusion Criteria: gastroesophageal reflux patients with uncontrolled psychiatric disorders active infections or malignancies other concomitant pathology considered as a contraindication for bariatric surgery
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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: regular diet<br>The patients receive regular diet of 900 Kcal/day during 15 days before surgery | Dietary Supplement: Regular diet<br>* The patients receive regular diet 900 Kcal/day during 15 days before surgery<br>|
| Active Comparator: high protein formula<br>The patients receive high protein formula during 15 days before surgery | Dietary Supplement: High protein formula<br>* The patients receive high protein formula during 15 days before surgery<br>|
| Experimental: Immunonutrition<br>The patients receive Immunonutrition during 15 days before surgery | Dietary Supplement: Immunonutrition<br>* The patients receive Immunonutrition formula during 15 days before surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative pain |  | 24 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| C reactive protein |  | 24 hours after surgery |
Physical Activity Levels of Parents of Children With Cystic Fibrosis- (PHACTS-CF)

Study Overview
=================
Brief Summary
-----------------
This study will investigate if parental physical activity levels, assessed by providing a physical activity questionnaire to parents of children aged 6-16 with Cystic Fibrosis (CF), is associated with their child with CF's physical activity levels. Children's activity levels will be taken from electronic records where a questionnaire is routinely given at annual reviews to analyse this. Parental activity levels will also be compared against adherence to nebulisers as a proxy for adherence to treatment, this data is again in the electronic records of patients and is collected at annual reviews.

Official Title
-----------------
Investigating Physical Activity Levels of Parents of Children With Cystic Fibrosis and Its Influence on Their Children's Physical Activity Levels and Nebuliser Use

Conditions
-----------------
Cystic Fibrosis in Children

Intervention / Treatment
-----------------
* Other: No intervention will be provided


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of Children aged 5-16 years. Under the care of Cambridge University Hospitals CF team Confirmed Cystic Fibrosis diagnosis Uses an ineb as main nebulizer delivery device. Parental/guardian permission (informed consent) and if appropriate, child assent. Exclusion Criteria: Parents of CYP diagnosed with a CF screen positive inconclusive diagnosis (SPID). If not yet doing lung function. If has any other self-identified physical disability which may limit physical activity.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: No intervention will be provided|No intervention will be provided, this is an observational study|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GPAQ | Activity questionnaire for parents | Reviews the past 7 days activities. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CPAQ | Physical activity Questionnaire for children aged 5-11 (From medical notes) | Reviews the past 7 days activities. | 
| YPAQ | Physical activity Questionnaire for children aged 12 and over (From medical notes) | Reviews the past 7 days activities. | 
| Ineb adherence | Adherence to recommended number of nebulised treatment from the i-adhere software downloaded from the ineb device. | 1 year | 
| Lung function | FEV1 (z-score and %), FVC (z-score and %), FEF2575 (z-score and %) (From medical notes) | Best score in the last 1 year. |
The Study of Infrared Imaging on Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Breast cancer can cause focal temperature increase on the breast skin due to vasodilatation mediated by NO secretion from cancer cells. Our study is to evaluate this situation and to assess the diagnostic efficacy of infrared imaging (thermography)on breast cancer.

Detailed Description
-----------------
Malignant breast neoplasms can secrete NO to induce focal vasodilatation and increased blood flow and angiogenesis to the tumor, thus increase the focal temperature, which can be evaluated by breast thermography (infrared imaging). We will evaluate the efficacy of infrared imaging for detection and diagnosis of breast cancer, and if infrared imaging can effectively differentiate malignant from benign breast dieases and the sensitivity, specificity, false-negative rate will also be estimated.

Conditions
-----------------
Breast Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal group: women who has normal mammograms or ultrasound in 6 months abnormal group: women who has suspicious findings on mammograms or ultrasound in recent 6 months Exclusion Criteria: women who don't fit the above inclusion criteria

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

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

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
-----------------
Breast neoplasms, diagnosis
Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment.

Study Overview
=================
Brief Summary
-----------------
aims to determine the accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to the actual thickness of LUS measured with manual caliper measurement during cesarean delivery. Study hypothesis: In women with previous cesarean delivery, determination of the LUS thickness can be done by trans-abdominal and transvaginal ultrasound at term pregnancy and compared to the actual thickness of LUS measured with a manual caliper at cesarean delivery. Study question: considering transabdominal & transvaginal ultrasound, which of them would be more accurate in the assessment of LUS thickness?

Official Title
-----------------
Transabdominal Versus Transvaginal Ultrasound to Assess the Thickness of the Lower Uterine Segment at Term in Women With Previous One Cesarean Section.

Conditions
-----------------
Trans Abdominal Ultrasound, Transvaginal Ultrasound, Lower Uterine Segment Thickness

Intervention / Treatment
-----------------
* Diagnostic Test: transabdominal ultrasound and transvaginal ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age (20:40 years old). Women at term (37:40 weeks). With singleton pregnancy. Presenting by vertex (cephalic presentation). Having adequate liquor. Previous delivered by cesarean delivery one time. Exclusion Criteria: Fetal malformations, e.g fetal hydrops. Uterine malformations, e.g bicornuate uterus. Placental malformations, e.g placenta praevia, placenta accrete. Uterine surgery is other than a cesarean, e.g myomectomy. Women in labor (painful, regular uterine contractions, cervical dilatation, tender scar, and discomfort is not stopped by sedation). Obese patients (BMI >30 kg/m2)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 40 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: transabdominal ultrasound and transvaginal ultrasound|Within a week before scheduled delivery,antepartum transabdominal and transvaginal ultrasound will be performed with moderately full bladder.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| accuracy test for measuring | The accuracy of measurement of the LUS thickness by trans-abdominal and transvaginal ultrasound at term pregnancy in comparison to actual thickness of LUS measured with manual caliper at cesarean delivery. | 1 week |
Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France

Study Overview
=================
Brief Summary
-----------------
No structured organization for ovarian first line management emerges in France. Management across France seems to depend on regional contexts. Regions display no specific organization or delineate regional network for the ovarian cancer management or report centralized management revolving around referent centers. These different templates present a major problem in identifying differences, costs and benefit. To deal with this issue the Investigators propose a health economic evaluation based on cost-effectiveness analyses, completed with a budget impact analysis. This study will investigate the cost-effective management of patients with initial ovarian cancer using databases representative of different parts of French territories.

Official Title
-----------------
Optimisation of Disease Management in Patients With Epithelial Ovarian Cancer in France

Conditions
-----------------
Ovarian Epithelial Cancer

Intervention / Treatment
-----------------
* Other: Patient with ovarian epithelial cancer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ovarian epithelial cancer initially diagnosed in 2012 Age > 18 years old Residency in France (Rhône-Alpes region, District of Calvados and Cotes d'Or) First-line ovarian epithelial cancer Exclusion Criteria: Relapsed ovarian epithelial cancer Non epithelial ovarian cancer

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patient with ovarian epithelial cancer<br>Ovarian epithelial cancer diagnosed in 2012 | Other: Patient with ovarian epithelial cancer<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental cost-effectiveness ratio expressed in cost per relapse-free year gained | To perform a cost-effectiveness analysis in order to evaluate the most efficient organization for ovarian cancer in 1st line ot treatment | 2 years after diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incremental cost-effectiveness ratio expressed in cost per QALY(Quality-Adjusted Life Year) gained. |  | 2 years after diagnosis | 
| Budget impact analysis | Cost assessment performed retrospectively for each patient: hospital stays, visits and other health-related costs will be identified and measured based on the French national Health Insurance perspective. QALY (Quality-Adjusted Life Year) | 2 years after diagnosis | 
| Relapse-free survival (RFS) |  | RFS will be assessed 2 years after diagnosis |