linjc16/ctgov huggingface dataset:
Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer

Study Overview
=================
Brief Summary
-----------------
Zetiq has introduced a histochemical stain that claims to tinctorially identify cancer and neoplastic cells. Because of the potential importance of such a capability, the investigators undertook to investigate Zetiq's CellDetect® staining technology as applied to cultured cell lines as well as an initial sample of clinical cases. This goal was pursued by investigating four types of comparisons: 1) cancer cell lines before and after differentiation; 2) cervical squamous-cell carcinoma (SCC) biopsies to non-neoplastic squamous epithelium; 3) SCCs to neoplastic, nonmalignant squamous epithelium; and 4) neoplastic squamous cells to non-neoplastic squamous cells in cytological preparations. The clinical material was also stained with hematoxylin and eosin (biopsies) or Pap (cytologies) for diagnostic purposes. The investigators found that all CellDetect®-stained cells exhibited one of the two tinctorial outcomes. Cell lines with malignant phenotype uniformly had red/purple cytoplasm, whereas the differentiated phenotype changed the color to blue/green.

Official Title
-----------------
Evaluation of the Zetiq Histological and Cytological Staining Technique for the Detection Cervical Cancer

Conditions
-----------------
Cervical Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: FEMALE SUBJECT BETWEEN 18 AND 75 YEARS OF AGE. ABILITY TO PROVIDE INFORMED CONSENT Exclusion Criteria: SUBJECT WITH KNOWN PREGNANCY AT TIME OF SCREENING. PREVIOUS HISTORY OF HYSTERECTOMY PARTICIPATION IN ANOTHER CLINICAL TRIAL WITHIN LAST 30 DAYS.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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 |
| --- | --- |
| normal samples<br> | |
| premalignant/carcinoma samples<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
-----------------
Zetiq CellDetect ® stain, distinct red/purple color to the cytoplasm of neoplastic, distinguishes green/blue stained non-neoplastic cells and tissues
The Relationship Between Morphology and Virulent Genes of Candida Albicans and Clinical Aspects, Surveillance of Fungemia

Study Overview
=================
Brief Summary
-----------------
Candida albicans is the most common and important clinical fungal pathogen. Our previous surveillance disclosed that fluconazole could induce different morphological changes in clinical strains. Our current study on C. albicans causing candiuria disclosed that renal insufficiency , diabetes mellitus, respiratory failure and uremia were risk factors of treatment failure. However, we also found results of E-test drug susceptible test could not predict outcome. Hence, retrospective analysis of 31 months period, cases that had C. albicans inducing candidemia were reviewed and 60 cases were enrolled for morphological study and potential virulent gene analysis. This study is designed to clarity the clinical meaning of morphological form and virulent genes on candidemia. To do this study is probably helpful for treatment of candidiasis.

Official Title
-----------------
The Relationship Between Morphology and Virulent Genes of Candida Albicans and Clinical Aspects, Surveillance of Fungemia

Conditions
-----------------
Candidemia Prognostic Factor and Mycobiological Analysis.

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 2007 to 2010 medical records Cases with candidemmia of Candida albicans with available clinical information in medical records for analysis. Cases with candidemmia of Candida albicans which clinical isolates were preserved. Exclusion Criteria: Cases were not hospitalized for treatment and data were not available for analysis.

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Candida albicans, fungemia , prognostic factor
A Caspase Inhibitor in Chronic Hepatitis C (HCV) Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if IDN-6556, when given orally, is safe and effective in patients with chronic hepatitis C virus infection.

Official Title
-----------------
A Dose Response Study of a Caspase Inhibitor in Hepatitis C Patients

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

Intervention / Treatment
-----------------
* Drug: IDN-6556
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Chronic hepatitis C infection Unsuccessful prior HCV treatment Liver impairment (either AST or ALT 1.5-10.0 x ULN) Alpha-fetoprotein <= 50 ng/mL Adequate hematologic parameters Exclusion Criteria: Decompensated or severe liver disease Hepatocellular carcinoma HIV infection Co-infection with hepatitis B virus (HBV) Renal impairment Pancreatitis Use of illicit or drugs of abuse History of alcohol abuse Presence of clinically significant cardiac arrhythmias If female, pregnant or lactating

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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br> <br> |
| Active Comparator: IDN-6556 5 mg twice a day (BID)<br> | Drug: IDN-6556<br> <br> |
| Active Comparator: IDN-6556 25mg twice a day (BID)<br> | Drug: IDN-6556<br> <br> |
| Active Comparator: IDN-6556 50 mg twice a day (BID)<br> | Drug: IDN-6556<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median absolute change in aspartate transaminase (AST) values measured from baseline to Week 10 |  |  | 
| Median absolute change in alanine aminotransferase (ALT) values measured from baseline to Week 10 |  |  |
Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The aim is to determine the sensitivity and specificity of a screening tool to identify patients who undergo ACL reconstruction (non-copers) after 3 months of standard rehabilitation following an anterior Cruciate ligament (ACL) injury.

Detailed Description
-----------------
All included patients are referred to municipal rehabilitation to resolve effusion and range of motion deficits before the first screening (baseline screening) is completed. Hereafter the patients follow 3 months municipal rehabilitation before the second screening (3 months screening). A physiotherapist performs the screening and at the second screening, this is performed prior to consulting an orthopaedic surgeon.

Official Title
-----------------
Rate of Non-copers to Non-surgical ACL Treatment After 3 Months of Rehabilitation - a Prospective Cohort Study

Conditions
-----------------
Anterior Cruciate Ligament Injuries

Intervention / Treatment
-----------------
* Other: Standard rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral primary ACL injury Index injury no older than 6 months Exclusion Criteria: Multiligament rupture Large cartillage or meniscus injuries Scheduled ACL reconstruction within 3 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Standard rehabilitation|Patients follow standard municipal rehabilitation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients undergoing ACL reconstruction after 3 months of standard rehabilitation | Patients undergoing ACL reconstruction after 3 months of standard rehabilitation are defined as non-copers to the non-surgical treatment, which will define the sensitivity and specificity of the screening examination. | 3 months |
Compare Bioavailability of RO7239361 After Subcutaneous Injection

Study Overview
=================
Brief Summary
-----------------
Randomized study in healthy men and women. Assess the similarity of RO7239361 when injected into the arm, thigh, or the stomach. Collect data on safety of RO7239361.

Official Title
-----------------
An Open-label, Randomized, Parallel-group, Single Dose Study to Compare the Bioavailability of Subcutaneous Injections in the Arm, Thigh, and Abdomen and to Evaluate the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of RO7239361 in Healthy Participants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: RO7239361


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy participant as determined by no significant deviations in normal medical and surgical history and assessments Body Mass Index 18 kg/m2 to 32 kg/m2 females must be of non-childbearing potential Exclusion Criteria: tattoos or other skin findings on any of the potential injection sites history of chronic muscle pain within 30 days prior to study treatment prior history of IgG1 therapy Other protocol defined inclusion and exclusion criteria apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A: RO7239361<br>RO7239361 subcutaneous injections on specified days; abdomen | Drug: RO7239361<br>* Specified dose on specified days<br>|
| Active Comparator: Treatment B: RO7239361<br>RO7239361 subcutaneous injections on specified days; arm | Drug: RO7239361<br>* Specified dose on specified days<br>|
| Active Comparator: Treatment C: RO7239361<br>RO7239361 subcutaneous injections on specified days; thigh | Drug: RO7239361<br>* Specified dose on specified days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maximum observed serum concentration (Cmax) |  | Up to 92 days | 
| AUC from time zero to time of last quantifiable concentration [AUC(0-T)] |  | Up to 92 days | 
| AUC from time zero extrapolated to infinite time [AUC(INF)] |  | Up to 92 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events ( AEs) |  | Up to 92 days | 
| Incidence of Serious Adverse Events (SAEs) |  | Up to 92 days | 
| Change from baseline in electrocardiogram findings |  | Up to 92 days | 
| Change from baseline in physical examination findings |  | Up to 92 days | 
| Change from baseline in clinical laboratory test findings |  | Up to 92 days |
Dark Halo and MNV: a Study Between ICGA and OCTA

Study Overview
=================
Brief Summary
-----------------
The aim of study is to compare the evaluation of dark halo area of macular neovascularization (MNV) between indocyanine green angiography (ICGA) and optical coherence tomography angiography (OCTA) in order to identify OCTA as effective and useful biomarker in MNV

Detailed Description
-----------------
Dark halo is defined as a dark perilesional of flow decrease due to an area of reduced choroidal flow adjacent to the macular neovascularization (MNV). The detection of MNV vascular details was only possible through invasive dye injection, such as fluorescein angiography (FA) or indocyanine green angiography (ICGA). Optical coherence tomography angiography (OCTA) is a recent imaging technique that is able to detect the perfusion and non-perfusion areas carefully. The aim of study is to compare the evaluation of dark halo area of MNV between ICGA and OCTA

Official Title
-----------------
Dark Halo a New Biomarker in Macular Neovascularization: a Comparative Study Between ICGA and OCTA

Conditions
-----------------
Macular Neovascularisation

Intervention / Treatment
-----------------
* Diagnostic Test: Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 55 years diagnosis of macular neovascularization absence of previous treatment with anti-Vegf injections absence of other retinal vascular diseases Exclusion Criteria: age younger than 55 years absence diagnosis of macular neovascularization presence of previous treatment with anti-Vegf injections presence of other retinal vascular diseases

Ages Eligible for Study
-----------------
Minimum Age: 55 Years
Maximum Age: 85 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 |
| --- | --- |
| MNV group<br>Eyes affected by MNV. The dark halo of MNV was evaluated by OCTA and ICGA | Diagnostic Test: Optical Coherence Tomography Angiography (OCTA) and indocyanine green angiography (ICGA)<br>* OCTA and ICGA is able to detect the dark halo as a area of reduced perfusion around MVN<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dark halo measurement | The OCTA and ICGA parameters analyzed are: the area of dark halo (mm2) that surrounds the coroidal neovascularization. | three years |
Recycling of Chronic Smokers to Sustained Abstinence

Study Overview
=================
Brief Summary
-----------------
To develop and to test a brief telephone intervention following clinic treatment for smoking cessation.

Detailed Description
-----------------
DESIGN NARRATIVE: A total of 1,083 chronic smokers were randomly assigned either to a traditional state-of-the-art smoking cessation clinic or to the clinic supplemented by telephone support for recycling. Telephone outreach consisted of three separate rounds of intervention three months, nine months, and 21 months after the targeted date for quitting in the smoking cessation clinics. Telephone calls to abstinent subjects reinforced success and offered advice and support in coping with difficult situations. Calls to relapsers and nonabstainers debriefed concerning the relapse episode (as appropriate) and encouraged subjects to initiate concrete action toward quitting including setting a quit date. Subjects were offered self-help materials as well as referrals to more intensive programs. Follow-up data collection was separate from recycling contacts and occured six, 12, 24, and 34 months after the initial smoking cessation clinics. Projected longterm sustained abstinence rates were 35 percent for recycling and 25 percent for the clinic only comparison. If results were as predicted, an effective low-cost telephone outreach protocol was made available that could dramatically assist in smoking cessation and thereby substantially reduce cardiovascular disease.

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Lung Diseases

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

Ages Eligible for Study
-----------------
Maximum Age: 100 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 |
| --- | --- | --- |
Posterior Capsule Opacification (PCO) With AcrySof Single-Piece IOL

Study Overview
=================
Brief Summary
-----------------
The purpose of this study what to evaluate if axial myopia might influence the development of PCO.

Detailed Description
-----------------
We sought to prospectively compare PCO in eyes with myopia in relation to axial length with PCO in eyes with normal axial length, to decipher the role of axial myopia in PCO 4 years after surgery for senile cataract.

Official Title
-----------------
Prospective Evaluation of Posterior Capsule Opacification in Myopic Eyes 4 Years After AcrySof Single-Piece IOL Implantation

Conditions
-----------------
Posterior Capsule Opacification

Intervention / Treatment
-----------------
* Procedure: Phaco


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: local residency and presence of a cataract in an otherwise normal eye. Patients older than 50 years a dilated pupil after mydriasis Patients with retinochoroidal atrophy, retinal laser prophylaxis, hypertension Exclusion Criteria: nondilating pupil after maximal dilation; pseudoexfoliation; mature, traumatic, black, or complicated cataracts; previous intraocular surgery; previous surgery for glaucoma; uveitis diabetes mellitus Patients who did not give consent preoperatively

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 70 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1. MYOPIA<br>axial length > 26.00 mm | Procedure: Phaco<br>* AcrySof Single-Piece IOL<br>* Other names: normal axial length;|
| Active Comparator: 2. Emmetropia<br>emmetropic eyes- eyes with an axial length of 21.00 to 23.99 mm | Procedure: Phaco<br>* AcrySof Single-Piece IOL<br>* Other names: normal axial length;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the percentage area of PCO with posterior capsule opacity (POCO) software |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the presence of PCO within the central 3-mm zone were noted |  | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PCO, POCO
Blood Samples to Evaluate Biomarkers of Donor Chimerism

Study Overview
=================
Brief Summary
-----------------
We are interested in patient-specific factors that may affect the balance of recipient cells and donor cells in patients who receive stem cell transplants. We will look at the way the patient's body breaks down two drugs, fludarabine and mycophenolate mofetil, and how these two drugs affect the patient's body.

Official Title
-----------------
Blood Samples to Evaluate Biomarkers of Donor Chimerism

Conditions
-----------------
Leukemia, Hodgkins Disease, Non-hodgkins Lymphoma, Myelodysplastic Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with a hematologic disease or malignancy Scheduled to receive nonablative conditioning with fludarabine and total body irradiation Donor is well-matched by high resolution DNA techniques. Scheduled to receive postgrafting immunosuppression of oral MMF (CellCept) and an oral calcineurin inhibitor. Age >18 years at the time of enrollment. Exclusion criteria: -Diagnosed with an immunodeficiency disorder

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 |
| --- | --- | --- |
| Donor T-cell chimerism |  | Day 28 post-transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exposure to fludarabine and mycophenolate mofetil and their breakdown products. |  | Before and after transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hematopoietic stem cell transplantation, fludarabine, mycophenolate mofetil, mycophenolic acid, biomarkers
The Association Between Cervical Cancer Screening and Cancer Occurrence

Study Overview
=================
Brief Summary
-----------------
To investigate the protective effect of cervical cancer incidence and mortality by screening attending frequency or screening pattern, and to evaluate the possible risk of developing malignancies among women with cervical lesions, inflammation or infection.

Official Title
-----------------
The Association Between Cervical Cancer Screening Participation and Corresponding Results and Subsequent Cancer Occurrence and Death

Conditions
-----------------
Cervical Cancer, Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
The eligibility criteria in the proposal are specified in different part of analyses respectively, which are briefly listed below: Part I: Include women covered by national screening program and they did not have previous cervical cancer history before the study initiate date. Part II: Include women ever participated cervical cancer screening and exclude women with previous cervical cancer history before screening attending. Part III: Include women without previous cervical cancer history before the follow-up initiation. Part IV: Include women without previous cervical cancer history before the follow-up initiation.
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 |
| --- | --- |
| Entire Taiwan women<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
-----------------
Pap smear screening