linjc16/ctgov huggingface dataset:
Vitrectomy With Planned Foveal Detachment for Refractory DME With or Without Vitreo-macular Interface Abnormality

Study Overview
=================
Brief Summary
-----------------
To evaluate the therapeutic efficacy of sub retinal BSS injections in conjunction with conventional vitrectomy for refractory Diabetic macular edema (DME)- resistant to more than one anti-VEGF agent, intravitreal corticosteroids and to previous vitrectomy. Some of enrolled cases had normal vitreo-macular interface (VMI) relationship, while other cases had incomplete vitreoretinal separation with vitreomacular attachment (VMA).

Official Title
-----------------
Evaluation of Vitrectomy With Planned Foveal Detachment as Surgical Treatment for Refractory Diabetic Macular Edema With or Without Vitreo-macular Interface Abnormality

Conditions
-----------------
Chronic Edema of the Macula

Intervention / Treatment
-----------------
* Procedure: vitrectomy with planned foveal detachment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cases with refractory DME with a central macular thickness (CMT) of more than 300 µm despite undergoing anti-VEGF therapy (5-6 monthly injections of ranibizumab (IVR) or bevacizumab (IVB) with shifting to aflibercept (IVA) for additional 3 injections). Exclusion Criteria: The major exclusion criteria were: (1) presence of apparent retinal pigment epithelium (RPE) atrophy at or near the macula; (2) presence of proliferative diabetic fibrovascular membranes threating or at the macula; (3) presence of diabetic optic atrophy; and (4) presence of neovascular glaucoma.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: included cases<br>vitrectomy done with planned foveal separation and followed for the result | Procedure: vitrectomy with planned foveal detachment<br>* 23 gauge vitrectomy, posterior hyaloid detachment, internal limiting membrane peeling , sub-macular BSS injection using 38 gauge canula<br>* Other names: vitrectomy with submacular BSS injection;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| central macular thickness decrease | decrease in central macular thickness by OCT | 10 months postperative |
Stent Versus Conservative Treatment in Patients With Deep Venous Obstruction

Study Overview
=================
Brief Summary
-----------------
Patients will be randomised between deep venous stenting or conservative management

Official Title
-----------------
A Randomized Controlled Trial Comparing Venous Stenting With Conservative Treatment in Patients With Deep Venous Obstruction

Conditions
-----------------
Deep-Venous Thrombosis, Deep Venous Stenting, Randomized Clinical Trial

Intervention / Treatment
-----------------
* Device: deep venous stenting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 years Meet criteria for PTS or Patients with May Thurner syndrome on additional imaging Life expectancy of more than one year Deep venous thrombosis > 1 year Signed informed consent Exclusion Criteria: Previous intervention of central veins (inferior vena cava, iliac veins, common femoral vein) on the affected limb Known pregnancy Inability to answer Dutch QoL questionnaires or limited communication in Dutch (written and spoken) Contra-indication for prolonged anticoagulant treatment Recent, <1 year, deep venous thrombosis or pulmonary Embolism Known contrast allergy Known dialysis or renal insufficiency needing additional preparation for injection of contrast

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: deep venous stent<br>Patients will receive deep venous stenting in the iliaco(femoral) region | Device: deep venous stenting<br>* Deep venous stent<br>|
| No Intervention: conservative managment<br>Conservative management of complaints | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Life score | Quality of Life score | 12 months |
Chronic Non Bacterial Prostatitis: a Trial of TRUS Guided Injection of Betamethason

Study Overview
=================
Brief Summary
-----------------
TRUS guided injection of long acting corticosteroids in chronic non bacterial prostatitis patients who failed to response to medical treamtment

Detailed Description
-----------------
chronic non bacterial prostatitis is usually due to congestion combined with severe inflammatory process of the prostate, it is usually a recurrent bothersome problem, so patients who fail to response to classic medical treatment are expected to benefit from a strong anti inflammatory injection like betamethasone, which has strong anti inflammatory plus anti oedematous properties so limitation of this inflammatory process across the prostate is expected to relieve the patients symptoms

Official Title
-----------------
Managment of Refractory Cases of Chronic Non Bacterial Prostatitis by TRUS Guided Injection of Betamethason

Conditions
-----------------
Chronic Non Bacterial Prostatitis

Intervention / Treatment
-----------------
* Drug: Betamethason Sodium Phosphate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic non bacterial prostatitis who failed medical treatment Exclusion Criteria: chronic bacterial prostatitis patients

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: chronic non bacterial prostatitis
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: trus guided betamethason injection arm<br> | Drug: Betamethason Sodium Phosphate<br>* Injection of betamethasone in chronic non bacterial prostatitis patients using Trans rectal Ultrasound<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing IPSS before and after injection. | Questionnaire comparing IPSS (international prostatic symptom score) before and after injection | evaluation over 3 months after injection |
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia (PART 2)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the Efficacy and Safety of DWJ1252 in treatment of Functional Dyspepsia.

Official Title
-----------------
Efficacy and Safety of DWJ1252 in the Treatment of Functional Dyspepsia: A Multicenter, Randomized, Double-blind, Active-controlled Study (PART 2)

Conditions
-----------------
Functional Dyspepsia

Intervention / Treatment
-----------------
* Drug: DWJ1252
* Drug: Gasmotin
* Drug: Placebo of Gasmotin
* Drug: Placebo of DWJ1252


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female of at least 19 years old Patient with functional dyspepsia met the ROME III criteria Exclusion Criteria: Patients with previous gastrointestinal surgery Patients with history of gastrointestinal bleeding, mechanical obstruction, perforation Patients with history of gastrointestinal cancer

Ages Eligible for Study
-----------------
Minimum Age: 19 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: DWJ1252<br> | Drug: DWJ1252<br>* tablet<br>Drug: Placebo of Gasmotin<br>* tablet<br>|
| Active Comparator: Gasmotin<br> | Drug: Gasmotin<br>* tablet<br>Drug: Placebo of DWJ1252<br>* tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change from baseline in GIS (Gastrointestinal Symptom Score) |  | At 4 weeks |
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

Study Overview
=================
Brief Summary
-----------------
The human immune system produces a protein called hCAP18 (also known as LL-37 or cathelicidin). This protein is believed to help the body to fight infections. Studies suggest that vitamin D may important in the production of hCAP18. This study is designed to test the ability of two different forms of vitamin D to affect levels of hCAP18. Vitamin D and hCAP18 levels will be measured during an initial visit. Individuals who are vitamin D deficient will be randomly assigned to receive one of two forms of vitamin D for two weeks. After this, follow-up levels will be measured.

Official Title
-----------------
hCAP18 Levels and Vitamin D Deficiency in Chronic Kidney Disease

Conditions
-----------------
Chronic Kidney Disease, Vitamin D Deficiency

Intervention / Treatment
-----------------
* Drug: Ergocalciferol
* Drug: Calcitriol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-80 Chronic Kidney Disease stage 3-4 (estimated glomerular filtration rate 15-60 ml/min) Exclusion Criteria: 6 month history of hypercalcemia, hyperphosphatemia, or nephrolithiasis use of active vitamin D analog within 30 days functioning renal transplant Symptoms of active infection Granulomatous disorders

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ergocalciferol<br>Ergocalciferol intervention arm | Drug: Ergocalciferol<br>* Ergocalciferol 50,000 IU capsule, one dose every other day x 5 doses<br>* Other names: Vitamin D;|
| Experimental: calcitriol<br>calcitriol intervention arm | Drug: Calcitriol<br>* 0.25 mcg tablet once daily for 14 days<br>* Other names: vitamin d;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hCAP18 levels |  | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1,25-dihydroxyvitamin D |  | 2 weeks | 
| 25-hydroxyvitamin D |  | 2 weeks | 
| calcium |  | 2 weeks | 
| phosphorus |  | 2 weeks | 
| Parathyroid hormone |  | 2 weeks | 
| T-cell subsets | Measures of different types of T-cells | 2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Vitamin D, Chronic Kidney Disease
Multiple Dose Trial of Anti-glycation Agent GLY-230 in Healthy and Diabetic Subjects

Study Overview
=================
Brief Summary
-----------------
A dose-ranging study evaluating safety, metabolism and therapeutic dosing of three multiple dose levels of GLY-230 in healthy and diabetic subjects

Official Title
-----------------
A Dose-ranging Study to Evaluate the Safety, Metabolism and Therapeutic Dosing of Three Multiple Dose Levels of GLY-230 in Healthy and Diabetic Subjects

Conditions
-----------------
Diabetic Nephropathy

Intervention / Treatment
-----------------
* Drug: GLY-230
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Nondiabetic and diabetic men age 18-55, engative drug screen, normal EKG, clinical chemistries. hematology parameters, HbA1c 7.5% if diabetic, give written informed consent Exclusion Criteria: Sctive concomitant serious medical or surgical disease

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 250 mg<br> | Drug: GLY-230<br>* 125, 250 0r 375 mg bid for 14 days<br>|
| Experimental: 500 mg<br> | Drug: GLY-230<br>* 125, 250 0r 375 mg bid for 14 days<br>|
| Experimental: 750 mg<br> | Drug: GLY-230<br>* 125, 250 0r 375 mg bid for 14 days<br>|
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* No drug administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| glycated albumimin concentration |  | three weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine albumin |  | three weeks |
Extension Study to Evaluate Long Term Safety of Denosumab in Subjects Undergoing ADT for Non-Metastatic Prostate Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to describe the safety and tolerability of up to 5 years (ie, 3 years under the 20040138 Amgen study and 2 years on this study) denosumab administration as measured by adverse events, immunogenicity, and safety laboratory parameters in subjects who previously received denosumab for non-metastatic prostate cancer.

Official Title
-----------------
An Open Label, Single Arm, Extension Study to Evaluate the Long Term Safety of Denosumab (AMG 162) in the Treatment of Bone Loss in Subjects Undergoing Androgen-Deprivation Therapy for Non-Metastatic Prostate Cancer

Conditions
-----------------
Cancer, Carcinoma, Castrate-Resistant Prostate Cancer, Prostate Cancer, Tumors

Intervention / Treatment
-----------------
* Drug: Denosumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must be currently participating in the 20040138 Amgen study Subjects must sign the informed consent before any study specific procedures are performed. Exclusion Criteria Subjects with any prior diagnosis of bone metastasis Known hypocalcemia Developed sensitivity to mammalian cell derived drug products during the 20040138 study Currently receiving any investigational product other than denosumab or having received any investigational product during the 20040138 study Any disorder that, in the opinion of the investigator, may compromise the ability of the subject to give written informed consent and/or comply with study procedures

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

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

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: Arm 1<br> | Drug: Denosumab<br>* 60 mg SC of Denosumab will be administered on study day 1, month 6, month 12, and month 18<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall Survival Through Month 24 |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Androgen deprivation therapy for non-metastatic prostate cancer
Swiss Hemophilia Registry

Study Overview
=================
Brief Summary
-----------------
The Swiss Hemophilia Registry will collect data on the prophylactic and therapeutic use of factor concentrates in patients with hemophilia and other severe bleeding disorders in Switzerland.

Conditions
-----------------
Hemophilia and Other Severe Bleeding Disorders

Intervention / Treatment
-----------------
* Other: Registry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of hemophilia or other severe bleeding disorders. Signed inform consent 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: Registry|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of incidence of disease and inhibitor development | Demographics, Comorbidties, factor consumption for prophylaxis, bleeding and surgery, inhibito develeopment | 1 year |
Detection of COVID-19 Using Breath Analysis - Validation Study

Study Overview
=================
Brief Summary
-----------------
DETECTION OF THE 2019 NOVEL CORONAVIRUS (SARS-CoV-2) USING BREATH ANALYSIS- VALIDATION STUDY

Detailed Description
-----------------
A diagnostic prospective single-site study, with no anticipated risks or constraints. Primary objective- To validate the value of a set of breath VOC biomarkers that enable us to distinguish between Coronavirus (SARS-CoV-2) carriers and SARS-CoV-2-negative in comparison to the gold-standard testing methodology.

Official Title
-----------------
Detection of the 2019 Novel Coronavirus (SARS-CoV-2) Using Breath Analysis - Validation Study

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Diagnostic Test: Breath Biopsy Analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 6 to 75 years at the time of consent Capable of understanding written and/or spoken language Able to provide informed consent Was not treated with Anti-viral drugs Exclusion Criteria: Age under 6 years old Under guardianship or deprived of liberty Pregnant or lactating woman

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: COVID-19 patients<br>subjects who were found as COVID-19 positive patients by swab RT-PCR | Diagnostic Test: Breath Biopsy Analysis<br>* Analysis of a single breath Biopsy<br>|
| Other: Healthy controls<br>subjects who were found as COVID-19 Negative, by swab RT-PCR | Diagnostic Test: Breath Biopsy Analysis<br>* Analysis of a single breath Biopsy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of Volatile Organic Compounds indicating carriers of COVID-19. | Comparison of Volatile Organic Compounds found among COVID-19 carriers and Healthy controls. | Through the study completion, up to 3 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association of exhaled biomarkers with participants' characteristics (age, gender, symptoms-severity, etc.). | Correlation level between exhaled biomarkers and participants' demographic characteristics. | Through the study completion, up to 3 months. | 
| sensitivity level of biomarkers' algorithm. | comparison of algorithm's sensitivity level to the sensitivity of COVID-19 swab TEST. | Through the study completion, up to 3 months. |
Success of Inferior Alveolar Nerve Block in Women Taking Selective Serotonin Reuptake Inhibitors

Study Overview
=================
Brief Summary
-----------------
To evaluate the success of inferior alveolar nerve block (IANB) for mandibular molars with irreversible pulpitis in women under treatment with selective serotonin reuptake inhibitors (SSRIs).

Detailed Description
-----------------
Seventy patients with a diagnosis of symptomatic irreversible pulpitis in one mandibular molar were assigned to either SSRI users or SSRI non-users groups. SSRIs users were 45 women who take SSRIs referred for endodontic treatment from a psychiatric clinic to the clinic of the endodontic department of Isfahan University of Medical Sciences. SSRIs non-users were 45 women who did not take SSRIs referred for endodontic treatment to the same dental clinic. The protocol of the study was approved by the Ethics Committee of the university (no. 394867). Written informed consent was obtained from all the patients. The level of anxiety of the patients was determined by using the Corah Dental Anxiety Scale. The patients registered their baseline pain severity using a Heft-Parker visual analogue scale (HP-VAS). Two standard IANBs (1.8-mL cartridges) of 2% lidocaine with 1:100,000 epinephrine (Darupakhsh, Tehran, Iran) were administered to each patient. Fifteen minutes after injection, the teeth were isolated. Access cavity preparation was started. The patients was instructed by the same operator to mark his or her pain experienced during the access cavity preparation.

Official Title
-----------------
Anesthetic Success of Inferior Alveolar Nerve Block for Mandibular Molars With Symptomatic Irreversible Pulpitis in Women Taking Selective Serotonin Reuptake Inhibitors

Conditions
-----------------
Local Anesthesia

Intervention / Treatment
-----------------
* Drug: selective serotonin reuptake inhibitor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: vital mandibular molar tooth diagnosis of symptomatic irreversible pulpitis Exclusion Criteria: younger than 18 years old history of significant medical conditions allergies to local anesthetics or sulfites pregnancy active sites of pathosis in area of injection inability to give informed consent

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: selective serotonin reuptake inhibitor|Taking any type of SSRI medicaments|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the success rate of the IAN block |  | taking any type of SSRI for at least six weeks prior to the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inferior alveolar nerve block, irreversible pulpitis, selective serotonin reuptake inhibitor antidepressants