linjc16/ctgov huggingface dataset:
The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.

Study Overview
=================
Brief Summary
-----------------
To examine the relationship between morphological and functional results in eyes after vitrectomy due to the full thickness macular hole (FTMH).

Official Title
-----------------
The Application of M-charts and Microperimetry for the Assessment of Visual Function in Patients After Vitrectomy Due to the Full Thickness Macular Hole.

Conditions
-----------------
Macular Holes, Microperymetry, Vitrectomy, M-charts

Intervention / Treatment
-----------------
* Diagnostic Test: Microperymetry
* Diagnostic Test: M-charts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The diagnosed full thickness macular hole and psuedophakia. Exclusion Criteria: macular pseudohole, non-full thickness macular hole, retinal detachment, other ocular comorbidities.
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group of 22 patients<br>Group of 22 patients who underwent vitrectomy due to macular hole | Diagnostic Test: Microperymetry<br>* Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality.<br>Diagnostic Test: M-charts<br>* The M-chart (Inami Co., Tokyo, Japan) is a diagnostic tool developed by Matsumoto to quantify the degree of metamorphopsia in patients with macular diseases.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The best-corrected visual acuity (BCVA) | Acuity is a measure of visual performance. The eye exam seeks to find the prescription that will provide the best corrected visual performance achievable | 1 to 6 months | 
| Amsler test | The Amsler grid, consisting of evenly spaced horizontal and vertical lines, has been widely used since 1947 to test the metamorphopsia. | 1 to 6 months | 
| Central retinal thickness | Quantitative thickness measurements derived from the fast macular scan algorithm report retinal thickness at several locations including the center point, central subfield, and 4 inner and 4 outer zones of the macula. | 1 to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal sensitivity | Microperimetry is a procedure to assess retinal sensitivity while fundus is directly examined; it enables exact correlation between macular pathology and corresponding functional abnormality. It is a psychophysical method which is rapid, safe and non-invasive. | 1 to 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
macular hole, microperymetry, vitrectomy, m-charts, metamorphopsia
Cost-Effectiveness in Bladder Cancer

Study Overview
=================
Brief Summary
-----------------
This randomized clinical multicentre trial aims to evaluate the efficacy of microsatellite analysis on voided urine to detect tumour recurrences in the follow-up of patients with superficial urothelialcell carcinoma (UCC). Further, this study aims to identify subgroups of patients with a low risk of tumour recurrence using clinico-pathologic tumour characteristics in combination with a genetic marker (FGFR3 gene), such that the frequency of follow-up contact can be reduced. The overall objective is to reduce the frequency of cystoscopy during follow-up in patients with superficial UCC, leading to an improvement in quality of life at equal or lower costs. This study evaluates the cost-effectiveness of follow-up in bladder cancer.

Detailed Description
-----------------
The randomized clinical study consists of two intervention arms. The control arm consists of a conventional follow-up based on regular monitoring for urinary bladder UCC recurrences by cystoscopy. In the test arm a proportion of the cystoscopies is replaced by microsatellite analysis on voided urine. Both arms will be stratified for clinical and pathological tumour parameters as well as for the mutation status of the prognostic FGFR3 gene mutation.

Official Title
-----------------
Cost-Effectiveness of Follow-up of Patients With Superficial Bladder Cancer

Conditions
-----------------
Bladder Cancer

Intervention / Treatment
-----------------
* Procedure: urinary analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with resectable pT1 or pTa, grade G1-G2 transitional cell carcinoma of the bladder which is biopsy proven Exclusion Criteria: Patients who present or presented with a transitional cell carcinoma of the bladder, stage pT2 or more invasive, or carcinoma in situ (CIS) and/or G3 diagnosed in history
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: urinary analysis|nan|

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
-----------------
superficial urothelial cell carcinoma, urinary analysis, Loss of heterozygosity, FGFR3 mutation, follow-up
App Based Study on the Symptoms of Patients With Allergic Rhinitis in the Pollen Season

Study Overview
=================
Brief Summary
-----------------
App-based study of allergy patients under medication in the pollen season to determine the effect of allergic rhinitis on the quality of life.

Detailed Description
-----------------
The project aims to determine the effects of rhinitis on everyday life and thereby identify the affected pathways, irrespective of age, gender or gender socioeconomic status to lead a healthy and active life.

Official Title
-----------------
App-basierte Patientenbefragung Von Allergiepatienten Unter Medikation in Der Pollenflug-Saison Zur Bestimmung Der Auswirkung Einer Allergischen Rhinitis Auf Die Lebensqualität

Conditions
-----------------
Allergic Rhinitis

Intervention / Treatment
-----------------
* Other: no specifications. Depending on the patients


Participation Criteria
=================
Eligibility Criteria
-----------------
inclusion criteria patients with allergic rhinitis exclusion criteria none
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no specifications. Depending on the patients|patients with allergic rhinitis|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| allergic symptoms of patients | allergic symptoms of patients during the pollen season | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Immunotherapy
Association of Vitamin D Binding Protein Polymorphisms With Response to HCV Therapy

Study Overview
=================
Brief Summary
-----------------
Introduction: Vitamin D binding protein (VDBP) is a potential modulator of immune response and is associated with clinical progression of many diseases. Our aim is to assess influence of baseline 25-hydroxyvitamin D levels and VDBP single nucleotide polymorphisms (SNPs), rs4588 (C>A) and rs7041 (G>T), on baseline clinical parameters and response to interferon based therapy in chronic Hepatitis C patients in Egypt. Methodology: Genotyping will be performed by RFLP (Restriction Fragment Length Polymorphism) in treatment naïve Hepatitis C patients and healthy controls. Vitamin D levels will be assessed by ELISA. HCV RNA quantification will be performed by PCR to assess therapy outcome.

Official Title
-----------------
Association of Vitamin D Binding Protein Polymorphisms With Response to Therapy in Chronic Hepatitis C Egyptian Patients

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

Intervention / Treatment
-----------------
* Genetic: WT+ Diplotype


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 years and ≤ 60 years, fasting blood sugar less than 115 mg/dl or 20% upper normal limit (140 mg/dl), HBA1C ≤ 7.5% in diabetic patients, normal serum creatinine, normal thyroid stimulating hormone level, negative Hepatitis B surface antigen, hemoglobin ≥ 12g/dl for male or ≥ 11g/dl for female, total leukocytes ≥ 3,500/mm3, ANC ≥ 1500/mm3, platelets ≥ 100,000/mm3, presence of HCV RNA by PCR and elevated liver enzymes within the preceding 6 months for patients with F1 fibrosis stage. Exclusion Criteria: hypersensitivity to interferon or ribavirin, decompensated liver cirrhosis (presence of ascites, esophageal varices or hepatic encephalopathy), hepatocellular carcinoma, body mass index>35 Kg/m2 and vitamin D supplementation.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients<br>WT+ Diplotype | Genetic: WT+ Diplotype<br>* 3 or 4 vitamin D binding protein major alleles<br>|
| Controls<br>WT- Diplotype | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SVR |  | 72 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VDBP, single nucleotide polymorphisms (SNPs), interferon based therapy, Egypt
Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study

Study Overview
=================
Brief Summary
-----------------
This is a biomedical research, prospective, mono centric, tolerance study Of the administration of subcutaneous teicoplanin in the treatment of osteoarticular infections.

Official Title
-----------------
Administration of Subcutaneous Teicoplanin in the Treatment of Osteoarticular Infections: Tolerance Study

Conditions
-----------------
Osteoarticular Infection

Intervention / Treatment
-----------------
* Drug: teicoplanin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years Inpatient orthopedic surgery Achieved a bone and joint infection documented gram + (staphylococci golden coagulase-negative staphylococci, enterococci, streptococci) Bacteria resistant to lincosamides, quinolones and rifampicin Bacteria susceptible to teicoplanin (MIC ≤ 4 mg / L) Balanced patient teicoplanin administered intravenously (2 successive doses between 30 and 40 mg / mL) Exclusion Criteria: Patient not affiliated to the social security Pregnant and lactating women Known hypersensitivity to teicoplanin (rash, ...) Patients with a central catheter or an implantable chamber Patient hemodialysis Patient has another participant biomedical research on a drug to prevent drug interactions Patient minor Patient major protected (protection of the court, wardship, trusteeship) Patient admitted for emergency or incapable of consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- |
| Experimental: teicoplanin<br>this group receive the teicoplanin | Drug: teicoplanin<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| measure of tolerance | The frequencies of adverse reactions at the injection site SC will be measured to assess the local tolerance of teicoplanin by SC. | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
subcutaneous teicoplanin, osteoarticular, infections, tolerance, teicoplanin
DPBRN Longitudinal Study of Dental Restorations Placed on Previously Un-restored Surfaces

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the quality and expected lifespan of fillings recorded in the DPBRN Reasons for placing the first restoration on permanent tooth surfaces study, and the factors affecting how long the fillings last.

Detailed Description
-----------------
This study is an observational follow-up of previously placed dental restorations (fillings) and is conducted during routine dental care visits.

Official Title
-----------------
Longitudinal Study of Dental Restorations Placed on Previously Un-restored Surfaces

Conditions
-----------------
Dental Caries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: participant in the DPBRN Reasons for placing the first restoration on permanent tooth surfaces study

Ages Eligible for Study
-----------------
Minimum Age: 6 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 |
| --- | --- |
| Dental Caries assessment<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
-----------------
Dental Caries, Assessments, dental materials
the National Colorectal Cancer Cohort (NCRCC) Study: National Colorectal Cancer Research Consortium

Study Overview
=================
Brief Summary
-----------------
NCRCC study is a national prospective cohort study including colorectal cancer screening population and stage Ⅰ-Ⅳ colorectal cancer patients.

Detailed Description
-----------------
NCRCC study is a large-scale multicenter study which includes 16 hospitals and research centers, establishing a national cohort which consists of two subcohorts (CRC Screening Cohort and Colorectal Cancer Patient Cohort). To assess risk factors for colorectal cancer and evaluate risk prediction model of colorectal cancer to identify the high-risk population. To discover, test and validate new biological markers (e.g. genetic, epigenetic, transcriptomic, metabolomics, proteomic and metagenomics biomarkers) for early diagnosis, prediction of clinical outcomes (e.g. therapeutic response, toxicity, surgical complications) and survivorship endpoints (e.g. recurrence, survival, quality of life, second primary cancer). To estimate associations of epidemiological determinants (e.g. medication and supplement use, diet, lifestyle pattern) with clinical outcomes and survivorship endpoints among CRC patients.

Official Title
-----------------
The National Colorectal Cancer Cohort Study-Precision Medical Research in Colorectal Cancer

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women Mentally/physically able to consent and participate Subjects aged ≥18 years old (Colorectal Cancer Patient Cohort, CRCPC), age 40-74 years (CRC Screening Cohort, CRCSC) Newly-diagnosed colon and rectal cancer for stages Ⅰ-Ⅳ (CRCPC) Exclusion Criteria: A history of colorectal cancer or bowel resection Non-Chinese speaking

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 |
| --- | --- | --- |
| colorectal cancer incidence |  | up to 15 years | 
| Disease-free and overall survival |  | up to 10 years | 
| Recurrence/metastasis |  | up to 5 years | 
| Adenoma or advanced adenoma incidence |  | up to 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of treatment-related toxicities characterized by the Common Toxicity Criteria for Adverse Events (CTCAE) |  | up to 5 years | 
| Second primary cancer incidence |  | up to 15 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer, cohort study, CRC screening
Eosinophilic Cystitis Mimicking Urothelial Neoplasia

Study Overview
=================
Brief Summary
-----------------
We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. T

Detailed Description
-----------------
A pooled 22 patients diagnosed with eosinophilic cystitis on microscopic examination in our hospital during four years were retrospectively studied.We explored the potential etiology, clinical and histopathology presentation of the eosinophilic cystitis cases, clinically mimicking urothelial neoplasia. Surgical procedure and clinical outcome also evaluated. Transurethral resection of the lesions were performed and pathologically examined, we re-examined the studied cases and made a clinical correlation.

Official Title
-----------------
Eosinophilic Cystitis Mimicking Urothelial Neoplasia: A Retrospective Study

Conditions
-----------------
Urinary Bladder Diseases

Intervention / Treatment
-----------------
* Diagnostic Test: Microscopic examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically suspected urothelial neoplasia Exclusion Criteria: Patients who did not complete the follow up period

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 90 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: Microscopic examination|All the studies cases are microscopically examined using the ordinary stains (hematoxylin and eosin) then the eosinophilic infiltration are counted in 10 high power field manually|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eosinophil cell count | Each tissue slide is retrieved and examined to count the eosinphils in the submucosa, positive cases revelaed more than 90% eosinophils of the whole inflammatory cells | 1 day |
Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to prove the bioequivalence of Levetiracetam 1000 mg Tablets under fed conditions

Official Title
-----------------
A Single Dose, 2-Period, 2-Treatment, 2-Way Crossover Bioequivalency Study of Levetiracetam 1g Tablets Under Fed Conditions

Conditions
-----------------
Seizures

Intervention / Treatment
-----------------
* Drug: Levetiracetam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No clinically significant abnormal findings on the physical examination, medical history, or clinical laboratory results during screening Exclusion Criteria: Positive test for HIV, Hepatitis B, or Hepatitis C. Treatment with known enzyme altering drugs. History of allergic or adverse response to Levetiracetam or any comparable or similar product.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Levetiracetam|1000 mg tablet|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| bioequivalence based on Cmax |  | 10 days |
Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study

Study Overview
=================
Brief Summary
-----------------
Cross-linking of the cornea increases the mechanical and biochemical stability of the stromal tissue. The purpose of this study is to assess the effectiveness of riboflavin-ultraviolet light induced cross-linking of corneal collagen in improving visual acuity and reducing progression of keratoconus in the Brazilian population.

Official Title
-----------------
Corneal Collagen Crosslinking With Riboflavin for Keratoconus Treatment: A Brazilian Study

Conditions
-----------------
Keratoconus

Intervention / Treatment
-----------------
* Procedure: Corneal Collagen Crosslinking


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age from 18 to 35 years. Diagnosis of Keratoconus. Progression of Ametropia. Written informed consent. Exclusion Criteria: Corneal Thickness < 395 micra at thinnest point. Other active ocular disease than keratectasia. Cornea Guttata. Previous ocular surgery. Pregnancy. Known sensitivity to riboflavin.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>The eye with the worst visual acuity receives the treatment. (the other eye serve as control). | Procedure: Corneal Collagen Crosslinking<br>* UV light and Riboflavin eyedrops every 5 minutes for 30 minutes.<br>|
| No Intervention: B<br>The eye with the best visual acuity do not receive the treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Keratometry |  | 3 months | 
| BSCVA (Best spectacle corrected visual acuity) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial cell count |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Keratoconus