linjc16/ctgov huggingface dataset:
Calcium Sulfate Spacer in Open Tibia Fractures

Study Overview
=================
Brief Summary
-----------------
Investigators will compare antibiotic impregnated Calcium sulfate versus PMMA versus nothing in these sub-segmental bone defects.

Official Title
-----------------
Calcium Sulfate Spacer in Open Tibia Fractures With Sub-segmental Bone Loss to Decrease the Need for Secondary Surgery

Conditions
-----------------
Open tíbia Fracture With Sub-segmental Bone Loss

Intervention / Treatment
-----------------
* Drug: Calcium Sulfate
* Drug: PMMA
* Other: No treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Open tibia shaft fracture treated with an IMN Exclusion Criteria: None

Ages Eligible for Study
-----------------
Minimum Age: 16 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Calcium Sulphate<br> | Drug: Calcium Sulfate<br>* Calcium Sulfate with abx will be used in the defect<br>|
| Active Comparator: PMMA<br> | Drug: PMMA<br>* PMMA with abx will be used in the defect<br>|
| Active Comparator: Nothing<br> | Other: No treatment<br>* The defect will not be treated<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With a Nonunion | Radiographic healing at one year with no additional surgery | One Year |
Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

Study Overview
=================
Brief Summary
-----------------
A prospective registry of patients admitted for stroke and evidence of Vertebral Artery Origin Stenosis (VAOS).

Detailed Description
-----------------
A prospective registry of stenting plus medical management for the prevention of recurrent stroke in patients with symptomatic Vertebral Artery origin Stenosis (VAOS). Looking at clinical outcomes at 30 days and 1-year post-treatment and angiographic outcomes at 1-year post-treatment.

Official Title
-----------------
Vertebral Artery Origin Treatment Via Endovascular Techniques Registry (VOTER)

Conditions
-----------------
Vertebral Artery Stenosis

Intervention / Treatment
-----------------
* Other: Observational Prospective Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients between 18 and 90 years of age Patient has experienced a posterior circulation ischemic event Patient has angiographically confirmed bilateral vertebral artery origin disease (Hypoplasia, occlusion, or stenosis). Patient has >50% stenosis on the side being targeted for therapy Exclusion Criteria: Pregnant women Contrast Indication to the use of anti-platelet drugs There is tandem vertebral or basilar artery stenosis The serum creatinin is >2.5 Baseline modified Rankin score is >3 < 5 years life expectancy

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational Prospective Registry|This is a prospective registry looking at patients admitted for stroke with evidence of Vertebral Artery Origin Stenosis. Patients clinical outcomes will be collected at 30 days and 1-year post-treatment and angiographic outcomes at 1-year post-treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of recurrent stroke or death | Recurrent stroke of any type or death from any cause | 1 Year post-treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Restenosis | Restenosis in VAOS patients treated with drug-eluting stents. | 1 Year post-treatment |
500mg Fulvestrant Versus Everolimus Plus Exemestane in MBC Patients Refractory to Previous AI

Study Overview
=================
Brief Summary
-----------------
500mg Fulvestrant versus Everolimus plus Exemestane in MBC patients refractory to previous AI

Detailed Description
-----------------
Fulvestrant versus Everolimus plus Exemestane for patients with Metastatic Breast Cancer resistant to Aromatase Inhibitors: the clinical experience from real -world

Official Title
-----------------
Fulvestrant Versus Everolimus Plus Exemestane for Patients With Metastatic Breast Cancer Resistant to Aromatase Inhibitors: the Clinical Experience From Real -World

Conditions
-----------------
Breast Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with ER/PR+，HER2- Metastatic Breast Cancer Patients who were refractory to previous Aromatase Inhibitors Patients treated with Fulvestrant or Everolimus plus Exemestane in any line in metastatic setting in Fudan University Shanghai Cancer Center，starting from 2013.06.01-2016.06.01 Available medical history Exclusion Criteria: 1.Incomplete medical history

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 |
| --- | --- |
| Fulvestrant<br>Fulvestrant 500mg per month (D1, D28, q28d), with a loading dose 500mg of first dose at D15 | |
| Everolimus plus Exemestane<br>Everolimys 10 mg or 5 mg daily; Exemestane 25mg per day | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PFS | Progression free survival | 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with treatment-related adverse events as assessed by CTCAE v4.0 |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Endocrine Therapy, Fulvestrant, Everolimus
Topcon 3D OCT-1000 Optical Coherence Tomography System

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical protocol is to perform a comparison of Retinal and Retinal Nerve Fiber Layer (RNFL) thickness measurements between the Topcon 3D-1000 and the identified predicate device. In addition, this protocol performs a comparison of the thickness measurement results from images collected and analyzed with the Zeiss Stratus OCT to images collected with the Zeiss Stratus OCT and imported into the Topcon 3D OCT-1000 StratusViewer for analysis.

Official Title
-----------------
Topcon 3D OCT-1000 Optical Coherence Tomography System for Measurements of Retinal and RNFL Thicknesses: Precision and Agreement Study

Conditions
-----------------
Retinal Disease, Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Retinal Disease Study No Retinal Disease: Inclusion Criteria: Male or female Between 18 and 80 years of age Either eye, but only one eye per subject will be enrolled Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5. Exclusion Criteria: Any known ocular disease Any systemic disease that could result in ocular manifestations such as hypertension, diabetes, heart disease, etc. Topcon image quality factor ≤ 44 or Stratus signal strength < 5. Retinal Disease Inclusion Criteria: Male or female Between 18 and 80 years of age Either eye, but only one eye per subject will be enrolled Symptoms consistent with one of the following retinal diseases: diabetic macular edema, cystoid macular edema, epiretinal membrane, macular hole, wet AMD and dry AMD for which OCT imaging is warranted. At lease one (1) case each of these diseases will be included in the study A range of retinal thickness will be included Topcon image quality factor ≥ 45 or Stratus signal strength ≥ 5. Exclusion Criteria: Presence of glaucoma Topcon image quality factor ≤ 44 or Stratus signal strength < 5.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>Patients with Retinal Disease | |
| 2<br>Patients without Retinal Disease | |
| 3<br>Normal Subjects | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Precision and Agreement Between the Topcon 3D OCT 1000 and the Identified Predicate Device | The precision and agreement measures the thickness of RNFL and Full Retinal Thickness of the study device and is compared to the predicate device to show agreement. Keywords, ILM - Internal Limiting Membrane RPE - Retinal Pigment Epithelium RNFL - Retinal Nerve Fiber Layer | 30 Minutes |
A Study of an Oral Nutritional Supplement in a Malnourished Population With GI Tolerance Impairment

Study Overview
=================
Brief Summary
-----------------
The purpose is to observe the compliance to a high-calorie, high protein peptide-based nutritional supplement after 3 months in a malnourished population with impaired gastrointestinal tolerance living in nursing homes and as outpatients.

Official Title
-----------------
A Prospective, Observational Study, of a High Calorie, Higher Protein Peptide Based Oral Nutrition Supplement (ONS) With Medium Chain Triglycerides (MCTs) in a Malnourished Population With GI Tolerance Impairment

Conditions
-----------------
Malnutrition

Intervention / Treatment
-----------------
* Other: Nutritional Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is considered malnourished, or is at risk for malnutrition based on MUST score ≥2. Subject is ≥18 years old. Subject has a condition that would benefit from a high calorie, higher protein ONS for GI tolerance impairment (e.g., diarrhea, nausea, vomiting, satiety or bloating). Subject conforms to the requirements set forth on the study product label. Subject is under the care of a health care professional for malnutrition and has recently (within the last 7 days prior to participating in this study) been prescribed 2 servings/day of the study ONS. Subject must have been naïve to ONS for GI tolerance impairment prior to being prescribed the study ONS. Exclusion Criteria: The study physician determines the subject is not fit to participate Subject cannot provide informed consent to participate in the study. Subject cannot safely consume the oral nutritional supplement. Renal or liver failure (GFR< 60 ml/min or AST/ALTx3 normal) upper limit. Type 1 or type 2 diabetes.

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

| Intervention/Treatment |
| --- |
|Other: Nutritional Supplement|High calorie, high protein peptide based|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Study Product Compliance | Subject reported diaries | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Body Weight |  | Baseline to Week 12 | 
| Nutrition Status | Healthcare Professional completed screening | Baseline to Week 12 | 
| Quality of Life | Subject reported questionnaire | Baseline to Week 12 | 
| Gastrointestinal Tolerance | Subject reported scale | Baseline to Week 12 | 
| Body Mass Index |  | Baseline to Week 12 |
Alveolar Dead Space as Predictor of Organ Failure in Severe Sepsis

Study Overview
=================
Brief Summary
-----------------
This is an observational study to understand the changes in alveolar dead space in medical critically ill patients with severe infection (severe sepsis) requiring mechanical ventilation and the possibility to predict multi-organ failure. The measurement of alveolar dead space used to require sophisticated equipment and time. New ventilators have microprocessors that allow rapid mathematical calculation with minimal intervention.

Detailed Description
-----------------
The patient will be followed during their ICU stay up to two weeks while on mechanical ventilation. Patient will be followed daily for the initial 48 hours and then once per week for 2 weeks while mechanically ventilated.

Official Title
-----------------
Alveolar Dead Space as Predictor of Multi-organ Failure and Mortality in Medical Intensive Care Patients With Sepsis Requiring Mechanical Ventilation

Conditions
-----------------
Sepsis, Severe Sepsis, Septic Shock, Multi-organ Failure

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults with severe sepsis or septic shock on mechanical ventilation Enrolled in the initial six hours of ICU admission Exclusion Criteria: Patients with withdrawal or hospice order. Patients with terminal, irreversible disease, expect to decease in 48 hours from ICU admission. Patients with COPD. Patients transferred from outside ICU with ongoing sepsis management for more than six 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multi-organ failure<br>Alveolar dead space on mechanically ventilated patients with severe sepsis or septic shock. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Multi-organ failure | Multi-oran failure will be accessed by daily laboratory data, heart function by echocardiogram if available, urinary output, vitals and use of vasopressors. | daily for 48 hours then weekly for 2 weeks. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality | All the patient will be followed up to 28-days to determine survival. | ICU mortality | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sepsis, Severe sepsis, Septic shock, Alveolar dead space, Multi-organ failure
C-reactive Protein Levels Among Individuals With COVID-19

Study Overview
=================
Brief Summary
-----------------
The primary objective of this multi-center study is to clarify the value of a CRP measurement for triage of patients initially presenting with light symptoms of the COVID-19 infection. Current recommendations of management of COVID-19 include large-scale tests for virus. Such tests reveal whether an individual is infected with the virus, however, the demonstration of virus per se has no prognostic value for the ensuing course of the COVID-19 disease. Publications of possible treatments strategies increase exponentially, while evidence of triage of the affected individuals is mainly based on the level of pulmonary affection as measured by the Oxygen saturation. To inform decision making for which patients are to be hospitalized due to risk of developing more severe affection, this study addresses the question, whether triage may be performed with the aid of a simple CRP measurement.

Official Title
-----------------
Triage Strategies Based on C-reactive Protein Levels Among Individuals With COVID-19: A Prospective Cohort Study

Conditions
-----------------
Coronavirus Infection

Intervention / Treatment
-----------------
* Diagnostic Test: C-reactive protein


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A test for COVID-19 taken at the check point Signed, informed consent for blood test to be drawn for the Biobank Exclusion Criteria: Former admission to hospital for COVID-19 Direct admission from check point.

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 |
| --- | --- |
| Suspected COVID-19<br>Individuals with symptoms who are seen at covid19 check points for covid19 diagnosis. | Diagnostic Test: C-reactive protein<br>* Measurement of CRP value from blood sample taken at covid19 check point (baseline).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation | Admission to a hospital. Reason for admission is recorded. | within 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Death |  | within 28 days | 
| Transfer to Intensive Care Unit |  | within 28 days | 
| Oxygen treatment during hospitalisation |  | within 28 days |
Lyske Trial (Danish) Groin Trial

Study Overview
=================
Brief Summary
-----------------
To examine the effect of a specific training programme towards groin injuries in male footbal players. To evaluate the effect on other football related injuries as well. To examine any possible relations between various possible predictors such as experience, age, hypermobility and others, and the risk of sustaining inujries during football.

Official Title
-----------------
Prevention of Groin Injuries in Football Players

Conditions
-----------------
Groin Injuries in Football Players

Intervention / Treatment
-----------------
* Behavioral: Specific training programme (behavior)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male adult football players playing in the participating clubs in the study period - Exclusion Criteria: under 18 years groin injury at the start of the study

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

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

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

| Intervention/Treatment |
| --- |
|Behavioral: Specific training programme (behavior)|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
-----------------
groin injury, football, prevention, traing programme, cluster randomized study
Randomized Study Comparing Two Established Gastrointestinal Suture Techniques - One-layer-continuous Versus Double-layer-continuous Suture

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the frequency of postoperative complications depending on the number of suture layers in colo-colonic and ileo-colonic anastomoses Hypothesis: double-layer suture has less anastomotic leakages compared to single-layer suture.

Official Title
-----------------
Randomized Trial to Compare Two Gastrointestinal Anastomosis Techniques - Single Layer Continuous Versus Double Layer Continuous

Conditions
-----------------
Colo-colonic Anastomoses, Ileo-colonic Anastomoses

Intervention / Treatment
-----------------
* Procedure: double layer-suture
* Procedure: Single-layer suture


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: at least 18 years old, planned for elective surgery at least one hand-sutured ileo-colonic or colo-colonic anastomosis Exclusion Criteria: ASA-Score > 3, missing written consent of the informed patient no existing choice between suture-techniques according to the surgeon patient not able to cooperate/non-compliance rectal anastomoses

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Double-Layer-Suture<br>Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread) | Procedure: double layer-suture<br>* Hand-sutured end-to-end or end-to-side anastomosis performed by double-layer continuous technique (monofil thread)<br>|
| Active Comparator: Single-layer suture<br>Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread). | Procedure: Single-layer suture<br>* Hand-sutured end-to-end or end-to-side anastomosis performed by single-layer continuous technique (monofil thread)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of clinical anastomostic leaks |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| death of any cause within 3 months post-operatively | all causes of death will be recorded independently of a possible causal relationship with the operation | 3 months | 
| postoperative morbidity |  | 30 days | 
| Duration of anastomosis (min) |  | 1-3 hours | 
| Frequency of anastomotic strictures |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hand-sutured colo-colonic and ileo-colonic anastomoses in elective surgery