linjc16/ctgov huggingface dataset:
A Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Study Overview
=================
Brief Summary
-----------------
The purpose of this data collection is to determine long term survival rate of ArComXL® highly cross-linked polyethylene

Detailed Description
-----------------
Approximately 500 patients (cases) will be enrolled in this data collection effort and 10-year follow-up will be attempted. Follow-up will be obtained by sending a questionnaire directly to the patients by mail. The follow-up will be annually and only survivorship data will be collected. This data collection project was developed in order to determine the actual long-term (10-year) survival rate of Biomet's ArCom XL highly cross-linked polyethylene. Data will be collated for uncemented cases only. This will eliminate the possibility of cement or cement debris being a confounding variable. The data gathered will be collated and used to provide feedback to designing engineers, support marketing efforts, and answer potential questions from reimbursement agencies.

Official Title
-----------------
A Prospective, Non-controlled, Clinical Investigation of ArComXL® Polyethylene in Total Hip Replacement

Conditions
-----------------
Osteoarthritis, Avascular Necrosis, Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non inflammatory degenerative joint disease including osteoarthritis and avascular necrosis Rheumatoid Arthritis Correction of Functional Deformity Treatment of non-union, femoral neck fractures, trochanteric fractures of the proximal femur with head involvement, unmanageable by other techniques Revision of previously failed total hip arthroplasty Uncemented applications Exclusion Criteria: Absolute contraindications Infection, sepsis and osteomyelitis Relative contraindications Uncooperative patient or patient with neurologic disorders who are incapable of following directions Osteoporosis Metabolic disorders which may impair bone formation Osteomalacia Distant foci of infections which may be spread to the implant site Rapid joint destruction, marked bone loss, or bone resorption apparent on roentgenogram Vascular insufficiency, muscular atrophy or neuromuscular disease
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ArComXL® polyethylene<br>ArComXL® polyethylene | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of revisions and removals | Patient questionnaire | Annually through 10 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Total Hip Arthroplasty, Total Hip Replacement, Hip Arthritis, Polyethylene
Evaluation of an Oligonucleotide Array for Rapid Identification of Dermatophytes in Clinical Specimens

Study Overview
=================
Brief Summary
-----------------
The nail specimens from patients with suspect onychomycosis were analyzed. Samples were collected as part of standard patient care from the Department of Dermatology, National Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan. Comparing the array results with the regular methods by sensitivity, specificity, NPV and PPV.

Detailed Description
-----------------
The nail specimens from patients with suspect onychomycosis were analyzed. Collection: Samples were collected as part of standard patient care from the Department of Dermatology, National Cheng Kung University Hospital (NCKUH, a tertiary referral hospital), Tainan, Taiwan. Nail samples were collected as subungual scrapings, clippings, or curettings. Samples were immediately transported in sterile Eppendorf tubes at room temperature to the laboratory of Department of Dermatology, NCKUH, for KOH stain and routine fungal cultures. Sample Prepare: Each sample was cut into small pieces with a surgical blade and homogenization by 2-ml glass homogenizer. The suspension treated by lyticase at 37°C for 30 min and extracted DNA with Blood & Tissue genomic DNA kit.PCR program and array hybirdization same with previous study. Analysis: If the results between array and culture method, discrepant analysis with re-sequencing, KOH mount and the patient's outcome of after antifungal treatment. The performance evaluation of the array and culture methods with Sensitivity, specificity, positive (PPV) and negative predictive value (NPV) were calculated after discrepant analysis. Significant difference was estimated by Fisher's exact test.

Official Title
-----------------
Evaluation of an Oligonucleotide Array for Rapid Identification of Dermatophytes in Clinical Specimens

Conditions
-----------------
Tinea Unguium, Onychomycosis

Intervention / Treatment
-----------------
* Device: Array


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Atypically results by culture and microscopy Suspect tinea infection Exclusion Criteria: Lost follow Not tinea unguium
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Regular Diagnosis<br>Difficult in regular diagnosis specimens, assistance with array. | Device: Array<br>* Applications of oligonucleotide array in diagnosis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oligonucleotide Array Detection Resluts | The species of pathogen provide by array method. | 1 weeks |
Acute Changes in Bioimpedance During Cardiac Resynchronization Therapy

Study Overview
=================
Brief Summary
-----------------
This study aims at Optimizing measured parameters to reflect underlying pathology in dyssynchronous hearts. This is an experimental study in patients were bioimpedance measurements are performed during implantation.

Detailed Description
-----------------
Patients who are eligible for implantation af a Cardiac Resynchronization Therapy Device according to European Society of Cardiology guidelines are included. Measurements are performed on implanted leads and stored for post Processing. The study entry ends for each patient With completion of the implantation procedure.

Official Title
-----------------
Acute Changes in Bioimpedance During Cardia Resynchronization Therapy

Conditions
-----------------
Heart Failure, Systolic

Intervention / Treatment
-----------------
* Diagnostic Test: Impedance measurements in Cardiac Resynchronization therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
- Indication for Cardiac resynchronization therapy or Upgrade of exciting Device according to the current European Society of Cardiology guidelines.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Determination of impedance signals<br>This single arm study is designed to measure impedance signals from implanted leads in different positions in the heart. Signals obtained at different pre specified position are compared to each other to determine the robustness of the acquired measurements. | Diagnostic Test: Impedance measurements in Cardiac Resynchronization therapy<br>* Bioimpedance measurements<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimization of Bioimpedance measurements | Acquisition of absolute and imaginary bioimpedance signals from electrodes of known location within the heart at different input current frequencies. Pacing is performed from Three different electrodes during acquisition of bioimpedance acquisition forming Three different groups. Wavelets of the signals are analyzed within each Group and compared within the Group and between the Groups. Optimization is achived when a discrimination factor that is calculated is improved. | 3 years |
The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that macrophages play a crucial role in the pathogenesis of atherosclerosis in patients with type 2 diabetes mellitus (T2DM).

Detailed Description
-----------------
Cardiovascular events are the leading cause of death in developed countries worldwide, including Taiwan. Type 2 diabetes mellitus (T2DM), previously considered merely as one of the risk factors, has been recently unanimously accepted to be coronary artery disease-equivalent. How T2DM may lead to accelerated atherosclerosis remains obscure. Hyperglycemia with or without hyperinsulinemia may lead to higher oxidative stress and generalized inflammation. The oxidative stress and inflammation may play a significant role in the pathogenesis in diabetic complications, including micro- and macro-vascular complications. Macrophages together with T-lymphocytes are the earliest cell-types found in fatty-streaks, the earliest atherosclerotic lesions. Macrophages are also well known cellular mediators of oxidative stress and inflammation. Therefore, it is plausible to hypothesize that macrophages play a crucial role in the pathogenesis of atherosclerosis in patients with T2DM. In addition, the other cell types of the peripheral white blood cells (WBC), such as neutrophils, have been shown to be intimately related to acute coronary syndrome. Therefore, the study on the biology of peripheral WBCs may tell us something about the pathophysiology of diabetic macro-vascular complications. Methods: Normal control: fasting plasma glucose (FPG) less than 126 mg/dl. T2DM: FPG >＝126 mg/dl. Group 1 (good glycemic control): hemoglobin A1c (HbA1c) <＝ 7% in the past 6 months Group 2 (poor glycemic control): HbA1c >＝ 8% in the past 6 months Blood sample will be collected at baseline and after aggressive control.

Official Title
-----------------
The Gene Expression Patterns in the Peripheral White Blood Cells of Type 2 Diabetic Patients, Special Relevance to Atherosclerosis

Conditions
-----------------
Diabetes Mellitus, Type 2, Atherosclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal control: fasting plasma glucose (FPG) less than 126 mg/dl. T2DM: FPG >＝126 mg/dl. Group 1 (good glycemic control): HbA1c<＝7% in the past 6 months Group 2 (poor glycemic control): HbA1c>＝8% in the past 6 months Exclusion Criteria: Acute systemic diseases

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 65 Years

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Diabetes mellitus, Monocyte, Gene expression, Monocyte gene expression
A New Supplement for the Immune Response to HPV Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate whether a supplement in which ellagic acid plus annona muricata are combined, may modulate the immune response to high risk HPV infection. Sixty women will be enrolled in a randomized, controlled study, having a histological diagnosis of L-SIL correlated with high rish HPV types infection. Main outcome measure is the activation of onco suppressor protein by the supplement and secondary outcome is the clearance of HPV infection in the treated group.

Official Title
-----------------
Ellagic Acid and Annona Muricata May Modulate the Immune Response to High Risk HPV Infection. A Randomized, Controlled Trial.

Conditions
-----------------
HPV Infection

Intervention / Treatment
-----------------
* Drug: ellagic acid + annona muricata


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with high risk HPV infection histological diagnosis of L-SIL Exclusion Criteria: women with no high risk HPV infection women without histological diagnosis of L-SIL

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: supplement<br> | Drug: ellagic acid + annona muricata<br>* pills<br>|
| Placebo Comparator: not intervention<br> | Drug: ellagic acid + annona muricata<br>* pills<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| variation of onco suppressor protein expression from basal values. The expression variations are represented by the different percentage of positive cells |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clearance of the HPV infection |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HPV, L-SIL
Whole Blood Specimen Collection From Pregnant Subjects

Study Overview
=================
Brief Summary
-----------------
To obtain whole blood specimens from pregnant subjects to be used for research and development and clinical validation studies of prenatal assays.

Detailed Description
-----------------
This sample collection protocol allows for the identification, recruitment, and participation in women who are pregnant and are known to: be at an increased risk for fetal genetic abnormalities be at increased risk for congenital fetal infection by virtue of being positive by initial screening tests, or are known to have an active infection during this pregnancy. possess irregular blood group antigens (the subject or the father of the baby) and are therefore at increased risk for fetal sensitization during this pregnancy.

Official Title
-----------------
Whole Blood Specimen Collection From Pregnant Subjects

Conditions
-----------------
Down Syndrome, Edwards Syndrome, Patau Syndrome, Klinefelter Syndrome, Turner Syndrome, DiGeorge Syndrome, Perinatal Infections

Intervention / Treatment
-----------------
* Other: Observational - no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject willing to provide consent to have up to 50 mL of whole blood collected at one or more monthly (≥25 days) clinic visits Subject is pregnant carrying a singleton fetus of 10 to 26 weeks gestational age inclusive Subject is 18 years of age or older Subject is at an increased risk for one or more of the following: fetal gene and chromosome abnormalities congenital fetal infection known to possess irregular blood group antigens (subject or father of the baby) known to have some other condition amenable to noninvasive prenatal testing Exclusion Criteria: Pregnancy is non-viable

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observational - no intervention|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Whole blood collection |  | One or more monthly clinic visits (≥25 days apart) over 13 weeks |
Life Quality Study for PFAPA Patient

Study Overview
=================
Brief Summary
-----------------
This cohort study aims to assess the quality of life (or welfare) related to the health of children and adolescents with an non genetics auto-inflammatory disease PFAPA or Marshall syndrome to compare it to children or adolescents with recurrent fever genetics of Familial Mediterranean fever (FMF) in order to improve their overall care.

Conditions
-----------------
PFAPA Syndrome

Intervention / Treatment
-----------------
* Other: Quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PFAPA syndrome patients or FMF patients Exclusion Criteria: Participation refusal

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum 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 |
| --- | --- |
| PFAPA group<br>Life quality for PFAPA patient report by themselves or parent | Other: Quality of life<br>* Quality of life<br>|
| FMF group<br>Life quality for FMF patient report by themselves or parent | Other: Quality of life<br>* Quality of life<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare quality of life from patients with PFAPA and FMF, reported by parents and by patients themselves |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the fatigue status of patients through questionnaire PedsQL TM 3.0 multidimensional scale tiredness |  | 1 day |
Rosiglitazone Effect on Mitochondria and Lipoatrophy

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain stavudine (d4T) or zidovudine (AZT).

Detailed Description
-----------------
This is a phase II, randomized, double-blind, placebo-controlled study of rosiglitazone for the treatment of HIV-associated lipoatrophy. Subjects will receive blinded study treatment for 48 weeks. This study will examine the effect of rosiglitazone on limb fat and mitochondrial indices in HIV-1-infected subjects receiving stable antiretroviral therapy that does not contain d4T or AZT. The study also will assess the safety and tolerability of rosiglitazone in this population, and its effect on carotid IMT, prevalence of metabolic syndrome, lipid parameters and glucose metabolism.

Official Title
-----------------
Placebo Controlled Study of Rosiglitazone in HIV Lipoatrophy

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

Intervention / Treatment
-----------------
* Drug: Rosiglitazone
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lipoatrophy Thymidine sparing ARV for at least 24 weeks Prior thymidine NRTIs for at least 12 months Exclusion Criteria: Diabetes Heart failure Liver disease Hormonal therapies

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Rosigitazone arm<br>Rosiglitazone active 4 mg BID | Drug: Rosiglitazone<br>* Rosiglitazone 4mg BID<br>* Other names: Glitazones, avandia;|
| Placebo Comparator: Placebo arm<br>Matching Placebo BID | Drug: Placebo<br>* Placebo for rosiglitazone<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Limb Fat at 48 Weeks | Limb fat was measured at baseline and visit week 48 using dual-energy x-ray absorptiometry (DEXA), and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups. | 48 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Change in the Carotid IMT of the Common Carotid Artery | Carotid IMT of the Common carotid artery (CCA) was measured at baseline and week 48, and change from baseline to week 48 (week 48 - baseline) was estimated for the treatment groups. | 48 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, mitochondria, lipoatrophy