linjc16/ctgov huggingface dataset:
Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores

Study Overview
=================
Brief Summary
-----------------
For decades there have been concerns about patellar resurfacing (PR) in total knee arthroplasty (TKA) and the individual preference of the surgeon is still the main determinant of whether or not resurfacing is applied. According to preference, surgeons can be categorized in 3 main groups of those who usually, selectively or rarely resurface. The aim of this prospective, randomized, controlled study to is compare the isokinetic performance and clinical outcome of TKAs with PR and without PR.

Detailed Description
-----------------
Patients undergoing TKA for primary osteoarthritis of the knee are randomly assigned to either the PR or non-PR groups. The differences between groups with respect to age, BMI, gender, and preoperative Knee Society Score (KSS), and isokinetic performance are evaluated. Patients are evaluated at postoperative 3, 6, and 12 months with KSS and at 6 months and 1 year with isokinetic measurements.

Official Title
-----------------
Patellar Resurfacing in Total Knee Arthroplasty Leads to Better Isokinetic Performance and Higher Clinical Scores

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

Intervention / Treatment
-----------------
* Device: patellar component


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 55 to 80 years unilateral primary osteoarthritis Exclusion Criteria: bilateral osteoarthritis inflammatory arthritis post-traumatic osteoarthritis previous knee surgery neuromuscular diseases

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 80 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: patellar resurfacing<br>patellar resurfacing in TKA | Device: patellar component<br>* patellar resurfacing<br>|
| No Intervention: non-resurfacing<br>non-resurfacing TKA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| isokinetic test | isokinetic test during extension and flexion of the knee | Change from preoperative isokinetic test results at 6th months and 12th months isokinetic test results | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee Society Score (KSS): It has two different subscales: Knee and Function 100-80: Excellent 79-70:Good 69-60:Fair below 60:Poor | Knee Society Score (KSS) | Change from preoperative KSS results at 3rd months, 6th months and 12th months KSS results | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
patellar resurfacing, isokinetic testing
A Study of Glaucoma Therapy to Treat Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a glaucoma therapy is safe and effective in treating patients with open-angle glaucoma or ocular hypertension.

Conditions
-----------------
Open-angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: AL-37807 Ophthalmic Suspension, 1.0%
* Drug: Latanoprost, 0.005% (Xalatan)
* Other: AL-37807 Vehicle
* Drug: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with open-angle glaucoma (with ot without pseudoexfoliation or pigment dispersion component) or ocular hypertension Other protocol-defined inclusion criteria may apply. Exclusion Criteria: Under 18 Other protocol-defined exclusion criteria may apply.

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: AL-37807 Suspension<br> | Drug: AL-37807 Ophthalmic Suspension, 1.0%<br>* One drop in the study eye(s) once daily for 28 days<br>|
| Active Comparator: Xalatan<br> | Drug: Latanoprost, 0.005% (Xalatan)<br>* One drop in the study eye(s) once daily for 28 days<br>* Other names: XALATAN;|
| Placebo Comparator: AL-37807 Vehicle<br> | Other: AL-37807 Vehicle<br>* One drop in the study eye(s) once daily for 28 days<br>|
| Experimental: Timolol Maleate<br> | Drug: Timolol Maleate Ophthalmic Gel Forming Solution, 0.5%<br>* One drop in the study eye(s) once daily for 28 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intra-ocular pressure (IOP) change at Day 28 from baseline (Day 0) |  | Day 28 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
open, angle, glaucoma, ocular, hypertension
Subcutaneous Adipose Tissue in Cases With Polycystic Ovarian Syndrome

Study Overview
=================
Brief Summary
-----------------
This study aimed to search whether whole body and subcutaneous adipose tissues increase in PCOS patients and whether these tissues are related to HOMA-IR and plasma adiponectin levels.

Detailed Description
-----------------
Fifty-two patients with PCOS and fifty-tree healthy controls who were matched for body mass index (BMI) and age (p=0.430, p=0.112, respectively) were enrolled in the study. Biceps, triceps, subscapular and suprailiac skinfold thicknesses (SFT) of all cases were measured via caliper device; mid-upper arm circumference (MUAC) via a tape; and body fat distributions via a bioelectrical impedance device. Insulin resistance was calculated via HOMA-IR while ELISA was used to measure plasma adiponectin.

Official Title
-----------------
Relationship of Subcutaneous Adipose Tissue With HOMA-IR and Plasma Adiponectin Levels in Cases With Polycystic Ovarian Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All of the women with PCOS had normal thyroid-stimulating hormone and prolactin (PRL) levels. Exclusion Criteria: Subjects with possible ovarian tumors, congenital adrenal hyperplasia, BMI greater than 35 kg/m2, any chronic renal or liver disease, were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationship of Subcutaneous Adipose Tissue with HOMA-IR and Plasma Adiponectin Levels in Cases with Polycystic Ovarian Syndrome | PCOS patients (the experimental group) had higher mean SFT values in all parts, mid-upper arm circumference values, whole body and trunk fat free mass amounts (FFM) and HOMA-IR values, while a lower adiponectin level. | 2 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCOS, Skinfold thickness, HOMA-IR
The Value of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis

Study Overview
=================
Brief Summary
-----------------
The etiological diagnosis of sepsis is the key to guide clinical treatment. Metagenomic sequencing (mNGS) is very suitable for the diagnosis of sepsis due to its rapid, accurate and not easy to be disturbed by the environment. However, the conventional pathogen mNGS has potential risks such as low detection rate, loss of intracellular bacteria and fungi. At present, the latest fully targeted pathogen capture mNGS technology makes up for the shortcomings of conventional methods by bidirectional enrichment of pathogen nucleic acids. The aim of this study was to explore the value of fully targeted pathogen capture mNGS in improving etiological diagnosis in patients with sepsis compared with conventional methods.

Detailed Description
-----------------
This study planned to continuously collect samples from patients with sepsis who were admitted to the intensive care Unit of our hospital from 2022.08 to 2024.07, and conduct whole-target pathogen capture mNGS detection and follow-up etiological diagnosis based on blind method. The clinical diagnosis with clear etiology was taken as the gold standard.

Official Title
-----------------
Diagnostic Test of Full-targeted Pathogen Capture Metagenomics Next Generation Sequencing in Etiological Diagnosis of Sepsis

Conditions
-----------------
Sepsis, Severe

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critical care patients aged ≥ 18 years old Patients with sepsis Exclusion Criteria: Lack of traditional pathogen detection results Discharge diagnosis without clear etiology

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sensitivity | The chance of testing positive for a pathogen in a sample judged by the gold standard | up to 3 year | 
| specificity | The chance of a negative test in a sample judged pathogen-free by the gold standard | up to 3 year |
An Investigational Study of MK0928 in Adult Outpatients With Insomnia (0928-014)(COMPLETED)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and effectiveness of MK0928 for insomnia (a sleep disorder).

Official Title
-----------------
A Double-Blind, Randomized, Multicenter, Placebo-Controlled, Parallel-Group Efficacy Study of MK0928 15 mg and 10 mg in the Treatment of Adult Outpatients With Primary Insomnia

Conditions
-----------------
Insomnia

Intervention / Treatment
-----------------
* Drug: gaboxadol
* Drug: Comparator: placebo (unspecified)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult outpatients who are between the ages of 18 and 64 Exclusion Criteria: Adults who do not have a diagnosis of insomnia (a sleep disorder)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: gaboxadol|Duration of Treatment: 3 months|
|Drug: Comparator: placebo (unspecified)|Duration of Treatment: 3 months|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported amount of sleep and time to fall asleep at night after 3 months |  | After 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported awakenings at night |  | After 3 months | 
| Sleep quality |  | After 3 months | 
| Functioning after 3 months |  | After 3 months |
The ENTERPRISE Study - Study of the Enterprise Self-Expanding Stent System

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and feasibility of the Cordis Neurovascular Self-Expanding Stent System to facilitate endovascular coil embolization of wide neck saccular intracranial aneurysms. Cordis Self Expanding Stent for use with embolic coils for the treatment of wide-neck, intracranial, saccular aneurysms arising from a parent vessel

Detailed Description
-----------------
This is a multi-center, prospective, non-randomized feasibility study including 30 subjects. Subjects will receive a safety follow-up evaluation at 30 days (+ two weeks) and an efficacy follow-up evaluation at 6 months (+ four weeks).

Official Title
-----------------
Cordis Neurovascular Feasibility Study of the Enterprise Self-Expanding Stent System to Facilitate Endovascular Coil Embolization of Wide- Neck Saccular Intracranial Artery Aneurysms

Conditions
-----------------
Aneurysms

Intervention / Treatment
-----------------
* Device: Cordis Self Expanding Stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with intracranial, wide-neck, saccular aneurysms Exclusion Criteria: Subject with Hunt and Hess Grade IV or V subarachnoid hemorrhage

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Cordis Self Expanding Stent|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful stent placement with satisfactory coil mass position angiographically. |  | immediately after post procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intracranial, Wide-neck, Saccular, Aneurysms
Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of csPCa in Lesions With PI-RADS Score 3

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to explore the effectiveness of 68Ga-PSMA PET/MRI for improving the detection of csPCa in lesions with PI-RADS score 3. This study is a prospective, observational study, single-center research. After recruiting patients who are suspected prostate cancer with a mpMRI PI-RADS version2 score of 3 and willing to perform prostate biopsy to identify the diagnosis, 68Ga-PSMA PET/MRI will be performed. Lesions will be reaccessed based on PET/MRI findings and compared with the pathological results.

Official Title
-----------------
Effectiveness of 68Ga-PSMA PET/MRI for Improving the Detection of Clinical Significant Prostate Cancer in Lesions With Prostate Imaging Reporting and Data System Score 3

Conditions
-----------------
Prostatic Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: males over 18 years old suspected for prostate cancer serum PSA between 4ng/ml and 20ng/ml in recent two months mpMRI PI-RADS version2 scores 3 in recent two months willing to undertake prostate biopsy no evidence of non-cancerous factors interfere PSA level, such as catheter insertion, bladder stones, urinary tract infections or drug (e.g. finasteride) ECOG 0-1 Exclusion Criteria: history of prostate biopsy or other operations history of prostate cancer associated treatment contraindications for MRI or PET examination (e.g. claustrophobia, pacemakers, hip metal implants, hyperglycemia, glomerular filtration rate less than 50 ml/min) not suitable for prostate biopsy (e.g. coagulation dysfunction, skin infection at perineal puncture site)

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

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

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 |
| --- | --- | --- |
| detection rate | detection rate of csPCa | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| detection rate | detection rate of non-csPCa | one year |
Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Prediction

Study Overview
=================
Brief Summary
-----------------
This study is going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis.

Detailed Description
-----------------
The prevalence of GDM is increasing all over the world. It has bad influence for both pregnant women and fetus. Early treatment is useful for GDM prevention. Therefore early screening is important for healthcare doctors to detect the potential patients. Glycated albumin (GA) is an optimal index for blood glucose evaluation compared to HbA1c, however it may be influenced by body weight and composition. The investigators are going to investigate the predictive ability of glycated albumin combined with body composition, including body weight, BMI, fat free mass and fat mass for gestational diabetes mellitus (GDM) diagnosis. This study recruit pregnant women before 12 weeks of their pregnant age and test GA level and body composition via bioelectrical impedance analysis. During 24-28 weeks of pregnant age, all participants will do the glucose tolerant test for GDM diagnosis.

Official Title
-----------------
The Predictive Ability of Glycated Albumin Combined With Body Composition for Gestational Diabetes Mellitus Diagnosis

Conditions
-----------------
Gestational Diabetes Mellitus in Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 20-45 Healthy, without heart disease, liver or kidney dysfunction, immune system or metabolic or infectious disease, Exclusion Criteria: Diabetes that appeared before pregnancy Pregnant with medical disease, such as asthma, hypertension, cardiovascular diseases, kidney diseases or liver disease. Hormone use in the recent 1 year Assisted reproduction pregnancy Multiple births Cannot complete the blood test or body composition examination

Ages Eligible for Study
-----------------
Minimum Age: 22 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| GDM<br> | |
| non-GDM<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the curve of GA combined with body composition for GDM diagnosis | prediction ability of GA and body compostion | May 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| correlative factors for GDM | regression model to detect correlative factors for GDM | May 2021 | 
| GDM prediction model establishment | multiple regression model to establish screening system for GDM | May 2021 |
Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE).

Detailed Description
-----------------
Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes.

Official Title
-----------------
Diagnosis of Pancreatic Cysts: Endoscopic Ultrasound With Fine Needle Aspiration (EUS/FNA), Direct Visualization, and Confocal Laser-induced Endomicroscopy-A Pilot Study

Conditions
-----------------
Pancreatic Cysts

Intervention / Treatment
-----------------
* Device: Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients scheduled for an EUS-FNA procedure of a pancreatic cyst, Aged above 18 years Granted written informed consent for the study can be included in the study. Exclusion Criteria: Contraindication for undergoing EUS/FNA procedure (such as unwilling or medically unstable patients, patients with severe coagulopathy, patients with poor visualization on EUS for various reasons, etc) Pregnant or breastfeeding Allergy to fluorescein Renal insufficiency

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 |
| --- |
|Device: Direct visualization and needle based confocal laser-induced endomicroscopy miniprobe|Patients will undergo the EUS-FNA procedure, as per standard of care, plus an additional direct visualization (fiber optic probe) and nCLE procedure with the prototype probes, which will add 10 minutes maximum to the EUS-FNA procedure. The probes will be positioned against the lining of the pancreatic cyst, and images will be acquired. After imaging, fine needle aspiration of the lesion will be performed, as usual.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the yield of combination modalities in the diagnosis of pancreatic cysts using EUS/FNA, Fiber optics (direct visualization probe), and prototype needle based confocal laser-induced endomicroscopy miniprobe (nCLE) | Data will be analyzed descriptively to include patient characteristics, procedural variables, and outcomes. | From the date of imaging until follow up for 6 months to two years. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pancreatic cysts, EUS/FNA, Needle-based Confocal Laser Endomicroscopy (nCLE), fiber optic imaging, EUS/FNA of pancreatic cysts