linjc16/ctgov huggingface dataset:
Single Cutting Guides System for the Installation of a Total Knee Replacement

Study Overview
=================
Brief Summary
-----------------
The knee prosthesis is a validated treatment for end-stage of knee osteoarthritis, and this intervention usually provides a significant improvement in the quality of life of patients. However, a significant percentage of patients (up to 30%) are disappointed with the outcome of the intervention. One hypothesis that could explain these poor results might be the poor positioning of implants. Individual cutting guides are produced after a CT scan response planning carried out according to the CT scan anatomy of each patient, and subsequently adapted to its real anatomy during surgery, thus theoretically better accuracy of the implementation over conventional techniques. It has been shown in the past that the navigation has been the gold standard in measuring the three-dimensional orientation of the implants during surgery, and this system is systematically used in the service for over 10 years.

Official Title
-----------------
Evaluation of the Accuracy of a Single Cutting Guides System for the Installation of a Total Knee Replacement

Conditions
-----------------
Knee Osteoarthritis

Intervention / Treatment
-----------------
* Other: Retrospective study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis. Exclusion Criteria: Patients under 18 years

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: Retrospective study|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in the quality of life of patients after Knee replacement |  | every 3 months over a period of one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Knee, Knee osteoarthritis, Knee replacement
Short-course Antimicrobial Therapy in Sepsis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the effect of a short course antimicrobial therapy (5-days) versus a 10-days therapy on sepsis-related organ dysfunction.

Official Title
-----------------
Trial of Short-Course Antimicrobial Therapy for Sepsis in Intensive Care

Conditions
-----------------
Infection, Sepsis, Severe Sepsis, Septic Shock

Intervention / Treatment
-----------------
* Drug: Antibiotic


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who received antibiotics for presumed infection Exclusion Criteria: Prolonged therapy (eg, endocarditis) Severe immunosuppression Severe infections (due to viruses, parasites, or Mycobacterium tuberculosis) Patients previously infected or colonized with multidrug resistant pathogens and moribund patients.
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 |
| --- | --- |
| Experimental: Group 5-days<br>5-days targeted antibiotic therapy | Drug: Antibiotic<br>* Targeted antimicrobial therapy<br>|
| Other: Group 10-days<br>10-days targeted antibiotic therapy | Drug: Antibiotic<br>* Targeted antimicrobial therapy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sepsis-related organ dysfunction | Score used to track a person's status during the stay in an intensive care unit (ICU) to determine the extent of a person's organ function or rate of failure. The Sequential Organ Failure Assessment (SOFA) score numerically quantifies the number and severity of failed organs. Higher values represent worse outcome. A score of 0 is given for normal function through to 4 for most abnormal. The systems studied are: respiratory, coagulation, hepatic, cardiovascular, central nervous system, and renal. | 14-days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital mortality | In hospital mortality rate | 30-days |
The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines

Study Overview
=================
Brief Summary
-----------------
Fever can develop after fiberoptic bronchoscopy (FB) in about 2.5 - 16 % of adult patients. We evaluated the impact of oral amoxicillin/clavulanate (AC) on incidence of postbronchoscopic fever and pneumonia.

Detailed Description
-----------------
For the population being undergone with bronchoscopy, the clinical signs and procedural measures for complication of bronchoscopy and cytokines will be checked.

Official Title
-----------------
The Impact of Antibiotic Prophylaxis on Incidence of Post-bronchoscopy Fever and Change of Serum Cytokines

Conditions
-----------------
Fever, Pneumonia

Intervention / Treatment
-----------------
* Drug: oral amoxicillin/clavulanate 1g (875/125mg)
* Drug: control


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: adult patients (aged 18 years or older) who underwent FB Exclusion Criteria: concurrent treatment with antibiotics or systemic corticosteroid

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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: control<br>control without intervention | Drug: control<br>* no intervention with the same procedure of FB<br>|
| Active Comparator: Amoxicillin/clavulanate<br> | Drug: oral amoxicillin/clavulanate 1g (875/125mg)<br>* oral amoxicillin/clavulanate 1g (875/125mg) on the day of the procedure 30 minutes prior to the FB<br>* Other names: prophylaxis group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of fever | time frame for body temperature 24hr before and after bronchoscopy every 4hrs | 24 hr after bronchoscopy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change of serum cytokines level | Time frame for cytokine measurement 24hr before brochoscopy - 1hr after bronchosocpy - 24hr after brochoscopy | before bronchoscopy and 24hr after bronchoscopy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchoscopy, post-bronchoscopy fever, pneumonia, cytokines, amoxicillin/clavulanate, prophylaxis
3-year Follow-up Study to Assess the Viral Activity in Hepatitis C Patients Who Failed Feeder DEB025/Alisporivir Study

Study Overview
=================
Brief Summary
-----------------
Follow-up for viral activity, changes in liver function and safety in patients with no SVR24 in feeder studies

Detailed Description
-----------------
The purpose of this study was to follow patients from the feeder studies who have not achieved SVR24 to assess their viral activity, and to assess the changes in liver function and disease, and post-treatment safety over time.

Official Title
-----------------
A Multi-centre 3-year Follow-up Study to Assess the Viral Activity in Patients Who Failed to Achieve Sustained Virologic Response in Novartis-sponsored Alisporivir-studies for Chronic Hepatitis C Patients

Conditions
-----------------
Hepatitis C, Chronic

Intervention / Treatment
-----------------
* Drug: Previous treatment in DEB025 study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females aged ≥18 Have previously completed a Novartis-sponsored hepatitis C study and received alisporivir or a direct antiviral agent (DAA) Have not achieved SVR24 Exclusion Criteria: Use of any investigational drugs within 5 half-lives of enrollment, or within 30 days of that medication, whichever is longer. Previous use of any course of hepatitis C therapy since the end of the Novartis-sponsored hepatitis C study

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Follow up from feeder studies<br>Follow up arm | Drug: Previous treatment in DEB025 study<br>* Follow-up after DEB025 active study<br>* Other names: Data was not collected;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HCV RNA Sequencing | Persistence of resistance associated variants | 27 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety Parameters as Measured by HCV RNA Sequencing | Phenotypic analysis of HCV isolates to determine the patients susceptibility/resistance to alisporivir in vitro | 27 months | 
| Safety Parameters as Measured by FibroScan/Fibrotest and Lab Parameters | Changes in liver function and disease over time | 27 months | 
| Safety Parameters as Measured by Liver UltraSound and Lab Parameters | Development of hepatocellular carcinoma (HCC) | 27 months | 
| Safety Parameters | Safety over time of previous alisporivir exposure | 27 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis C, chronic
hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
Vitamin D deficiency (low levels of vitamin D in the blood) is a common problem. A recently discovered protein, called hCAP18, likely plays an important role in the immune system and may depend on adequate levels of vitamin D. It is not known what levels of vitamin D are needed to allow the body to make this protein. Nor is it known if giving vitamin D to people who are found to be deficient will help boost levels of hCAP18. This study aims to clarify the relationship between vitamin D levels and hCAP18.

Official Title
-----------------
hCAP18 Levels and Vitamin D Deficiency in Healthy Subjects

Conditions
-----------------
Healthy Subjects, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: ergocalciferol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 Exclusion Criteria: Known active infectious disease or chronic inflammatory disorder Hypercalcemia Chronic kidney disease Pregnancy

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Vitamin D insufficient (treated with ergocalciferol 50,000 IU every other day x 5 doses) | Drug: ergocalciferol<br>* Ergocalciferol 50,000 IU given every other day for 5 total doses<br>* Other names: Vitamin D;|
| No Intervention: Vitamin D sufficient<br>Subjects who did not receive ergocalciferol and had a 25-OH vitamin D level >32 ng/ml | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hCAP18 Levels |  | Baseline | 
| Baseline 25-OH Vitamin D Level |  | Baseline |
Effect of Seminal Plasma Insemination on Pregnancy Rates After IVF-ET

Study Overview
=================
Brief Summary
-----------------
Seminal plasma insemination into the vaginal vault of patients undergoing IVF-ET increases uterine receptivity.

Conditions
-----------------
Effect on Implantation and Pregnancy Rates

Intervention / Treatment
-----------------
* Procedure: seminal plasma insemination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing oocyte pick up for IVF treatment Exclusion Criteria: endometriosis low responders uterine malformations

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 41 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: seminal plasma insemination<br>seminal plasma insemination | Procedure: seminal plasma insemination<br> <br> |
| Placebo Comparator: culture medium insemination<br>culture medium insemination | Procedure: seminal plasma insemination<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| implantation rate |  | 4 weeks after ET | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical pregnancy rate |  | 4 weeks after ET | 
| ongoing pregnancy rate |  | 6 weeks after ET | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
seminal plasma/uterine receptivity
Comparing FARES Method With SPASO Method for Reduction of Anterior Shoulder Dislocation: a Prospective Randomized Trial

Study Overview
=================
Brief Summary
-----------------
Shoulder anterior dislocation is a major disease entity in emergency department. There are more than 10 reduction methods that have been reported. Traditional reduction methods require sedatives, which could cause adverse effects on the patients such as respiratory suppression and allergy. There are some reduction maneuvers reported recently which do not need sedatives prior to performing reduction, including FARES method and SPASO method. So far, there are no well-designed study to compare these two methods. Besides, in clinical experience, we found that combining these two methods could even get higher successful reduction rate. This study is aimed to compare these two methods as a prospective randomized design, and furthermore, to show that combining these two methods could get higher successful reduction rate.

Official Title
-----------------
Comparing FARES Method With SPASO Method for Reduction of Anterior Shoulder Dislocation: a Prospective Randomized Trial

Conditions
-----------------
Shoulder Anterior Dislocation

Intervention / Treatment
-----------------
* Procedure: SPASO method and FARES method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: shoulder anterior dislocation conscious clear communicable Exclusion Criteria: unconscious non-communicable humeral neck fracture dislocation time > 24 hours neurovascular compromise

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SPASO method, FARES method<br>Reduction method: SPASO method, FARES method | Procedure: SPASO method and FARES method<br>* SPASO method and FARES method as shoulder dislocation reduction methods<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful reduction rate |  | Less than 30 minutes |
Induction of Stable Chimerism for Sickle Cell Anemia

Study Overview
=================
Brief Summary
-----------------
To investigate a modified hematopoeitic cell transplantation (HCT) procedure for sickle cell disease that significantly reduces the toxicity of HCT, yet retains its therapeutic benefit.

Detailed Description
-----------------
BACKGROUND: Hematopoietic cell transplantation (HCT) has curative potential for individuals with sickle cell disease. While the results of conventional HCT have been good, this treatment carries risks of significant short- term and longterm toxicities. For this reason, HCT has been reserved for children who have experienced severe symptoms that predict a poor outcome. Of interest, some patients developed stable donor-host hematopoietic chimerism after conventional HCT. Due to a natural enrichment of donor erythrocytes in the blood, those who developed stable chimerism had a significant clinical benefit, even when there was a minority of donor cells. These observations have paralleled efforts to develop less-toxic, non-myeloablative preparative regiments for transplantation, proved first in a canine model of transplantation, and subsequently translated successfully in a clinical trial for older adults with hematological malignancies. DESIGN NARRATIVE: Multicenter open-label phase I-II study in 30 children with sickle cell disease that combines a non-myeloablative pre-transplant hematopoietic cell transplantation (HCT) therapy with modulated post-grafting immunosuppression to control host-versus-graft and graft-versus-host reactions. The approach relies on the ability to establish and maintain donor-host chimerism. The primary study endpoint is stable donor cell engraftment; secondary endpoints measure the impact of therapy on sickle cell-related symptoms and end-organ damage (disease-free survival, patient survival, graft-versus-host disease, complications etc). The trial will be conducted within the existing network of Comprehensive Sickle Cell Centers, and will be centrally coordinated by the Sickle Cell Coordinating Center.

Conditions
-----------------
Blood Disease, Hematopoietic Stem Cell Transplantation, Anemia, Sickle Cell

Intervention / Treatment
-----------------
* Procedure: Hematopoietic Stem Cell Transplantation
* Drug: Immunosuppression


Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

Ages Eligible for Study
-----------------
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Treatment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Hematopoietic Stem Cell Transplantation|nan|
|Drug: Immunosuppression|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
A Safety and Efficacy of Pomalyst® Capsules Under the Actual Use in All Patients Who Are Treated With Pomalyst at a Dose of 1 mg, 2 mg, 3 mg, or 4 mg

Study Overview
=================
Brief Summary
-----------------
Planned enrollment period One year (The planned number of patients to be enrolled is set to 400 patients.) Since all patients who are prescribed with Pomalyst are registered in RevMate®, enrollment using the Registration Form of the surveillance will be completed at the time when the planned number of patients to be enrolled is reached. During a period until conditions for approval are removed, a system enabling to retrospectively collect appropriate information based on patient data from RevMate® will be, as necessary, maintained. Planned duration of the surveillance Anticipated to be 2 years and 6 months from the start date of release of Pomalyst

Official Title
-----------------
Pomalyst®Capsules Special Use-results Surveillance (All-case Surveillance)

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance. Exclusion Criteria: N/A

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 |
| --- | --- |
| Multiple myeloma patients who received Pomalyst<br>Among relapsed or refractory multiple myeloma patients, all patients who received Pomalyst will be targeted in this surveillance. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse event (AE) | Number of participants with adverse events | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
jaundice, Pomalyst, Teratogenicity, bone marrow suppression, thromboembolism, peripheral neuropathy, infection, tumour lysis syndrome, somnolence, depressed level of consciousness, confusion, fatigue, dizziness, acute renal failure, heart failure, arrhythmia, interstitial pneumonia, hypersensitivity, hepatic function disorder