linjc16/ctgov huggingface dataset:
In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance

Study Overview
=================
Brief Summary
-----------------
Observational: studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.

Detailed Description
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Study Phase Definition: Phase of investigation, as defined by the US FDA for trials involving investigational new drugs. Select only one. N/A: for trials without phases Observational Study Design Case-control: group of individuals with specific characteristics (e.g., conditions or exposures) compared to group(s) with different Time Perspective Cross-sectional: observations or measurements made at a single point in time, usually at subject enrollment Biospecimen Retention - select one Samples Without DNA - samples retained, with no potential for DNA extraction from any retained samples (e.g., fixed tissue, plasma) Biospecimen Description Sputum, whole blood, urine, tissue Enrollment Single group study Number of Groups/Cohorts Definition: Number of study groups/cohorts. Enter 1 for a single-group study. Many observational studies have one group/cohort; case control studies typically have two. One study group, anticipated samples in the rang of 400-500 samples 8. Arms, Groups and Interventions N/L Group/Cohort Label

Official Title
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In Vitro Activity of Tigecycline Among Key Bacterial Pathogens Exhibiting Multidrug Resistance

Conditions
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Infections, Bacterial

Intervention / Treatment
-----------------
* Drug: In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: All patients with infection with MDRs infections will be included Exclusion Criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Multidrug resistant (MDR)bacterial strains<br> | Drug: In Vitro activity of Tigecycline among key bacterial pathogens exhibiting multidrug resistance<br>* studies in human beings in which biomedical and/or health outcomes are assessed in pre-defined groups of individuals. Subjects in the study may receive diagnostic, therapeutic, or other interventions, but the investigator does not assign specific interventions to the subjects of the study.<br>|

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
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Tigecycline, MDR, Patient infected with multidrug resistance bacteria
ROCC Knee Data Collection

Study Overview
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Brief Summary
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This observational study intends to collect efficacy and safety data on ROCC Knee system.

Detailed Description
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The ROCC® prosthesis is a rotating platform with: Highly congruent surface contact, NON CONSTRAINED kinematics allowing posterior roll back until 110° then anterior in hyperflexion like a normal knee Allowing asymmetric movement

Official Title
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A Prospective, Multicentre Study Evaluating the Clinical Performance of the ROCC Knee Prosthesis

Conditions
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Arthritis of Knee

Intervention / Treatment
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* Device: Knee Replacement (with ROCC Knee prosthesis)


Participation Criteria
=================
Eligibility Criteria
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Patients suitable for Knee Replacement for: osteoarthritis, rheumatoid arthritis bone necrosis affecting two knee compartments, correction of genu varus, genu valgus or post-traumatic deformities, sequelae of prior procedures.

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

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

Accepts Healthy Volunteers
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No

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1 ROCC Knee prosthesis<br>Consecutive series of patients with ROCC Knee prosthesis. | Device: Knee Replacement (with ROCC Knee prosthesis)<br>* Knee Replacement (with ROCC Knee prosthesis)<br>* Other names: ROCC Knee prosthesis;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| American Knee Score |  | 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication |  | Any time | 
| Patient Satisfaction |  | 3 months, 1yr, 2yr, 3yr, 4yr and 5 yr |
Epigenetic Biomarkers for Alzheimer's Disease

Study Overview
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Brief Summary
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Alzheimer's disease (AD) is a neurodegenerative disorder with no know cure. The pathogenesis of late onset AD (LOAD) is complex and multifactorial in nature, with multiple susceptibility genes and environmental factors at interplay. The objective of this study is to improve our understanding of the risk factors of LOAD by conducting an epigenome wide study within patients of LOAD contrasted against their cognitively normal siblings.

Official Title
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Identification of Epigenetic Biomarkers for Alzheimer's Disease in Blood Using Epigenome-wide Analysis

Conditions
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Alzheimer Disease

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Sufficient Cantonese competency for cognitive test Written informed consent given Have at least one gender-matched cognitively normal sibling Exclusion Criteria: Subjects who refuse blood taking procedure Do not have a reliable family/caregiver informant (personal contact at least once a month)

Ages Eligible for Study
-----------------
Minimum Age: 50 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 |
| --- | --- | --- |
| DNA methylation |  | 5 years | 
| RNA-seq microbiome |  | 5 years | 
| Alzheimer's disease Assessment Scale-cognitive subscale (Adas-Cog) |  | 5 years |
Evaluation of the Safety of Intraarticular Aquamid Reconstruction Injection for Knee Osteoarthritis in Humans

Study Overview
=================
Brief Summary
-----------------
As the use of Aquamid Reconstruction as an intraarticular device on humans is a relatively novel treatment, it is relevant to assess the safety profile of the device in a safety study to evaluate the safety of the device. This is a retrospective single center cohort study of patients with osteoarthritis of the knee(s) that have been treated for knee OA referred to a clinical evaluation at our department. The study consists of one clinical visit, at which the patients medical history will be taken and upon informed consent adverse events data is collected from medical records. The study is retrospective.

Official Title
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Evaluation of the Safety of Intraarticular Aquamid Reconstruction Injection for Knee Osteoarthritis in Humans

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

Intervention / Treatment
-----------------
* Device: Aquamid reconstruction


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Previously treated with intra-articular Aquamid Reconstruction in the knee for knee osteoarthritis and referred to our clinic for evaluatino of possible adverse device events. Exclusion Criteria: - There are no exclusion criteria
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Aquamid Reconstruction<br>Patients that have been treated with at least one intra-articular injection of aquamid as a treatment of osteoarthritis of the knee | Device: Aquamid reconstruction<br>* Aquamid Reconstruction is a Polyacrylamide hydrogel that contains 2.5% polyacrylamide and 97.5% non-pyrogenic water, with a unique molecular structure that allows the normal water exchange with the surrounding tissue without losing shape. Aquamid Reconstruction is biocompatible, non-absorbable non-biodegradable, stable, and sterile. T Aquamid Reconstruction is injected into the knee joint cavity.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Device Events | The investigator will examine each participant for evidence of adverse device events (ADEs) retrospectively by review of medical records and participant interview, and currently by a clinical examination | Day 1 (at the clinical examination) |
Postoperative CRP Levels and Vaginal Cuff Hematoma

Study Overview
=================
Brief Summary
-----------------
After laparoscopic hysterectomy, authors aimed to determine cuff hematoma and a postoperative CRP value to help predict the other complications. A total of 136 patients who underwent total laparoscopic hysterectomy (TLH) were evaluated. CRP, White blood cell (WBC) and hemoglobin values (Hb) were measured on the 1st, 2nd and 7th days before and after the operation. Complications, pre-postoperative vaginal length and female sexual function were evaluated. Fourteen patients who developed cuff hematoma during postoperative follow-up were analyzed with the receiver operating characteristics (ROC) curve. ROC curves with the largest area under the curve for each inflammatory marker were compared in order to define the marker with higher diagnostic accuracy.

Official Title
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The Value of Postoperative CRP Levels to Predict Postoperative Vaginal Cuff Hematoma

Conditions
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Postoperative Hematoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:women who underwent TLH operation with benign gynecological indications Exclusion Criteria: Decided to switch to laparotomy during operation postoperative complication due to relaparotomy infection (including urinary system and lung infections) Blood transfusion after TLH with rheumatic diseases length of hospital stay due to wound infection
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 |
| --- | --- | --- |
| Relationship between CRP Levels and cuff hematoma; crp levels | The value of Postoperative CRP Levels to predict Postoperative Vaginal Cuff Hematoma ; To evaluate tissue trauma and surgical inflammatory responses, venous peripheral blood samples (C-reactive protein) were taken on the first, second and seventh day postoperatively. CRP values were measured under standardized conditions using turbidometry. CRP levels (mg / dl) were recorded. | 1 week | 
| Relationship between CRP Levels and cuff hematoma; cuff hematoma measurement | The patients were called to the outpatient clinic after the hysterectomy and evaluated by transvaginal ultrasonography (tvusg) for cuff hematoma.hematoma dimensions recorded in centimeters. | 15 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cuff hematoma, CRP levels
3E Extension Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the long-term efficacy and safety of entecavir 0.5 mg/d + adefovir 10 mg/d for treatment experienced chronic hepatitis B patients.

Official Title
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A 3-year, Open-lable, Multi-center Extension Trial of Entecavir Plus Adefovir Combination Treatment for Patients Previously Treated in EXPLORE, EXCEL and EFFORT Ex Study

Conditions
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Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who completed the EXPLORE or EXCEL studies, or subjects with hepatitis flare after treatment withdrawal in EFFORT study. Subjects who are willing to participate the extension study. Exclusion Criteria: Subjects who could not compliance with the protocol judged by investigators

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Treatment group<br> | Drug: oral entecavir 0.5mg daily and adefovir 10mg daily for 144 weeks<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of patients achieving HBV DNA< 300copies/mL at week 144 |  | Week 144 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentages of patients achieving HBV DNA <300copies/mL at week 48/96 |  | Week 48 & 96 | 
| The log10 reduction in HBV DNA from baseline of DRAGON study at week 48/96/144 |  | Week 48 & 96 &144 | 
| Percentage of patients with HBeAg loss or HBeAg seroconversion at week 48/96/144. |  | Week 48 & 96 & 144 | 
| Percentage of patients with ALT normalization at week 48/96/144 |  | Week 48 & 96 & 144 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Experienced Treatment
Early Detection of Neonatal Shock

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the hypothesis that advanced hemodynamic monitoring results in an earlier detection of circulatory failure in newborn infants

Official Title
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Early Detection of Shock in Critically Ill Newborn Infants. The Impact of Advanced Hemodynamic Monitoring

Conditions
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Impact of Advanced Hemodynamic Monitoring

Intervention / Treatment
-----------------
* Device: Advanced hemodynamic monitoring


Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: Birth weight >700 grams Arterial catheter in place Central venous catheter in place Informed consent from parents/legal representatives Exclusion Criteria: Life-threatening congenital defects Congenital heart defects, except patent ductus arteriosus and patent foramen ovale
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Newborns<br>Critically ill newborns admitted to level III neonatal intensive care unit of a university hospital, who will be monitored using transpulmonary ultrasound dilution (advanced hemodynamic monitoring) | Device: Advanced hemodynamic monitoring<br>* Comprehensive advanced hemodynamic monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac output assessed by transpulmonary ultrasound dilution and simultaneously clinically estimated cardiac output |  | 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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newborn, shock, hemodynamics, cardiac output, blood pressure
Protein Expression in Samples From Young Patients With Rhabdomyosarcoma

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying tissue samples from patients with cancer in the laboratory may help doctors learn more about changes that occur in DNA and identify biomarkers related to cancer. It may also help doctors find better ways to treat cancer. PURPOSE: This research trial studies protein expression in samples from young patients with rhabdomyosarcoma.

Detailed Description
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OBJECTIVES: To measure the protein expression of candidate proteins in human rhabdomyosarcoma (RMS) tumor samples. OUTLINE: Archived tumor tissue samples are analyzed for protein expression (i.e., Notch1, Hey1, FGFR4, and Sp1) by IHC techniques and standard commercially available antibodies. Candidate proteins are then correlated with each patient age, gender, rhabdomyosarcoma (RMS) tumor stage, and RMS tumor subtype.

Official Title
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Evaluating Candidate Protein Expression in Human Rhabdomyosarcoma (RMS)

Conditions
-----------------
Sarcoma

Intervention / Treatment
-----------------
* Genetic: protein expression analysis
* Other: immunohistochemistry staining method
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
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DISEASE CHARACTERISTICS: Tumor tissue samples from children with rhabdomyosarcoma (RMS) enrolled in the Children's Oncology Group clinical trials Alveolar rhabdomyosarcoma (ARMS) Embryonal rhabdomyosarcoma (ERMS) PATIENT CHARACTERISTICS: Not specified PRIOR CONCURRENT THERAPY: Not specified
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Genetic: protein expression analysis|nan|
|Other: immunohistochemistry staining method|nan|
|Other: laboratory biomarker analysis|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RMS protein expression profile |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
alveolar childhood rhabdomyosarcoma, previously treated childhood rhabdomyosarcoma, previously untreated childhood rhabdomyosarcoma, recurrent childhood rhabdomyosarcoma, embryonal childhood rhabdomyosarcoma
Reliability of Clinical Limb-length Measurements Methods

Study Overview
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Brief Summary
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There are numerous ways to measure limb length discrepancy in the clinical practice, although their reliability and accuracy are not well known. In our prospective diagnostic study we aimed to test the most popular methods and compare their results to EOS 3D reconstructions data.

Official Title
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Reliability Study of the Clinical Limb-length Measurements Methods Applied in Healthy Volunteers

Conditions
-----------------
Leg Length Inequality

Intervention / Treatment
-----------------
* Diagnostic Test: EOS
* Diagnostic Test: Clinical limb length measurements


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 18-30 years BMI: < 30 Without orthopaedic complaint Exclusion Criteria: Previous surgery on lower limb or spine Developmental disorder in the patients history

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 30 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 |
| --- | --- |
| Study group<br>18-30 year-old, healthy volunteers Age: 18-30 years BMI: <30 No previous surgery on lower limb or spine No known developmental disorder Without any orthopaedic complaint | Diagnostic Test: EOS<br>* EOS Micro Dose imaging will be done. SterEOS lower limb alignment reconstruction will be performed measuring the lim length.<br>* Other names: EOS 2D/3D scanning and SterEOS 3D reconstruction;Diagnostic Test: Clinical limb length measurements<br>* Clinical measurement of both lower limbs' length, 3 times in 3 different days by 3 observers. bony markers position (heel contour, patella and medial malleolus) in resupinate and side position also tape measuring: Spina iliaca anterior superior - medial malleolus umbilicus - medial malleolus greater trochanter - lateral malleolus in standing, sitting, resupinate and side position<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiological limb length | Limb length based on SterEOS 3D measurement | 6 months | 
| Intra- and interobserver reliability of the clinical lower limb measurements methods | Intra- and interobserver reliability of clinical length measuring methods will be calculated using the 3 separated measurement of the 3 observers. | 6 months | 
| Accuracy of the clinical lower limb measurements methods | Comparing the results of the radiological and clinical limb length results using the third measurement of the observers. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EOS 2D/3D, leg length inequality, leg length discrepancy, physical examination, length measurement