linjc16/ctgov huggingface dataset:
Red Cell Distribution Width (RDW) as a Prognostic Marker in ICU

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to verify if high values of RDW are useful prognostic marker for ICU mortality and 90-days mortality. Moreover, we will investigate the prognostic value of RDW in specific subgroup population with some clinical characteristic wich may modify RDW baseline values, i.e. transfused patients or patients with high markers of hemolysis

Conditions
-----------------
Blood Transfusion, Biochemical Marker

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Unselected ICU patients Exclusion Criteria: Length of stay in ICU <48 hours Hematological disease Age <18 years

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ICU patients<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 90-days mortality |  | 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU mortality |  | 90 days | 
| Length of mechanical ventilation |  | 90 days |
Comparing Safety and Efficacy of Combigan® and Lumigan® With Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated With Xalatan®

Study Overview
=================
Brief Summary
-----------------
Comparing Safety and Efficacy of Combigan® and Lumigan® with Lumigan® Alone in Glaucoma or Ocular Hypertension Subjects Treated with Xalatan®.

Conditions
-----------------
Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution
* Drug: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with glaucoma or ocular hypertension. Visual Acuity 20/100 or better in both eyes Exclusion Criteria: Any active ocular disease History of any intraocular surgery or glaucoma laser surgery within 3 months Contraindication to pupil dilation Use of topical, periorbital, intravitreal, or systemic steroid within 3 months

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: Combigan® + Lumigan®<br>COMBIGAN® (fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution) adjunctive to LUMIGAN® (bimatoprost 0.03% ophthalmic solution) | Drug: fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution; bimatoprost 0.03% ophthalmic solution<br>* 1 drop of fixed combination of brimonidine tartrate 0.2% timolol maleate 0.5% ophthalmic solution (Combigan®) taken approximately 12 hours apart, up to 2 times a day and 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken once every 24 hours.<br>* Other names: LUMIGAN®;|
| Active Comparator: Lumigan®<br>LUMIGAN® (bimatoprost 0.03% ophthalmic solution) plus Gen Teal® Mild (hypromellose 0.2% eye drops) used for masking purposes | Drug: bimatoprost 0.03% ophthalmic solution; hypromellose 0.2% eyedrops<br>* 1 drop of bimatoprost 0.03% ophthalmic solution (Lumigan®) taken approximately every 24 hours; mild lubricant eyedrops (Gen Teal® Mild) for masking purposes<br>* Other names: Gen Teal® Mild;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Diurnal Intraocular Pressure (IOP) at Week 12 | Mean Diurnal (average of 8 AM, 10 AM, and 4 PM time points) IOP at Week 12 in the study eye. IOP is a measurement of the fluid pressure inside the eye. | Week 12 |
Adhese One F Upgrade in Direct Filling Therapy

Study Overview
=================
Brief Summary
-----------------
Investigation on the clinical performance of a new dental adhesive when used in direct filling therapy after phosphoric acid etching. Hypothesis: The new adhesive shows an acceptable clinical performance and allows a good filling quality.

Official Title
-----------------
Clinical Evaluation of AdheSE One F Upgrade in Direct Filling Therapy

Conditions
-----------------
Dental Adhesive

Intervention / Treatment
-----------------
* Device: Adhese One F Upgrade


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: indication for class I or II filling max. 2 restorations per patient vital teeth sufficient language skills Exclusion Criteria: dry working field cannot be established if the patient is known to be allergic to any of the materials' ingredients severe systemic diseases pregnancy non-vital or pulpitic teeth indication for indirect restoration

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adhese One F Upgrade<br>Adhese One F Upgrade (AOFU) is administered after phosphoric acid etching (etch-and-rinse protocol). | Device: Adhese One F Upgrade<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Clinical Success | Clinical success is defined as no postoperative hypersensitivity and no loss of the restoration. | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Quality | The clinical quality of the restorations will be evaluated according to semi-quantitative clinical evaluation (SQUACE) criteria and compared at all time points and at the end of the study. SQUACE is a published semi-quantitative method to evaluate the clinical success of dental restorations that is based on the commonly used USPHS criteria. The quality of the restoration is rated according to the SQUACE scale and classified as acceptable or not acceptable. | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
total etch protocol, direct filling therapy
Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if the combination of DF289 plus DF277 is safe and effective in treating middle ear infections in children with ear tubes.

Official Title
-----------------
Clinical Study to Assess the Efficacy and Safety of DF289 Plus DF277 Otic Solution in the Treatment of Middle Ear Infections in Pediatric Patients

Conditions
-----------------
Acute Otitis Media

Intervention / Treatment
-----------------
* Drug: DF289
* Drug: DF277
* Drug: DF289 plus DF277


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 6 months to 12 years ear tube in the ear which will be treated otorrhea for 3 weeks or less moderate or severe otorrhea Exclusion Criteria: other ear diseases

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 12 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: DF289<br>Ear drops | Drug: DF289<br>* Ear drops<br>|
| Active Comparator: DF277<br>Ear drops | Drug: DF277<br>* Ear drops<br>|
| Experimental: DF289 plus DF277<br>Ear drops | Drug: DF289 plus DF277<br>* Ear drops<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Cessation of Otorrhea |  | From baseline until the end of the study ( up to 22 days) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
with tubes
Pediatric Hepatic Tumors

Study Overview
=================
Brief Summary
-----------------
Centralized biological collection of multicentric origin, retrospective and prospective of biological samples (tissues and fluids) taken within the framework of the diagnostic and therapeutic management of children and adolescents with liver tumor, and supported in the centers of French Society for Childhood Cancers (SFCE) with associated clinical database.

Official Title
-----------------
Constitution of a Centralized Biological Resources Collection and Associated With a Clinical Database for Childhood Liver Tumors Diagnosed in France (Retrospective Collection From 1990 and Prospective)

Conditions
-----------------
Liver Tumor

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - For inclusion in the clinical database: Children and adolescents (≤18 years at diagnosis) suffering from a primary liver tumor diagnosed after 01/01/1990 and treated in France Informed consent to the computerization of data signed by the patient or by parents or legal representatives if he is a minor. - For inclusion in the biological collection (CRB Paris Sud): Additional criteria: Availability of biological samples (tumor tissue, healthy tissue, plasma and / or serum). Informed consent to the use of biological remains signed by the patient or by parents or legal representatives if he is a minor. - For the inclusion of deceased patients: Obtaining consent or failing this, seeking non-opposition to the computerization of data (for inclusion in the database) and the use of biological remains (for inclusion in the biological collection) of the patient or both parents or the legal guardian if he is a minor. Exclusion Criteria: None

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Children and adolescents with liver tumor<br>Patients treated after 01/01/1990 for a primary liver tumor before the age of 18. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Establish a national bank of rare biological material |  | Up to 10 years |
Cardiovascular Registry of Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
Follow a representative sample of Latin American patients diagnosed with atrial fibrillation to set data on demographic characteristics, documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death

Detailed Description
-----------------
Patients will be followed 6 months and 1 year after the baseline visit and will be collected data of antithrombotic therapy, laboratory data, discontinuation rates of antithrombotic therapy and clinical outcomes.

Official Title
-----------------
Cardiovascular Registry of Atrial Fibrillation in Latin America: The LACROSS Study

Conditions
-----------------
Atrial Fibrillation, Atrial Flutter

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years-old that signed informed consent; Atrial Fibrillation or Atrial Flutter at the time of inclusion documented in source document; If the patient is not in atrial fibrillation or Atrial Flutter rhythm, s/he should have 2 electrographic records, at least 15 days apart between them, with one of them being performed within the last 6 months before enrollment (AF may be documented by 12-lead ECG, Holter monitor-24h); Exclusion Criteria: Patients who did not agree to participate. Patients without possibility of monitoring for one year.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Patient Registry Data|To set data on demographic characteristics,documenting antithrombotic therapy, describe the INR control level of VKA users, discontinuation rates and clinical outcomes, such as stroke, hemorrhage and death.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| INR control rate |  | 12 months | 
| Oral anticoagulation discontinuation rate |  | 12 months | 
| Percentage of death |  | 12 months | 
| Percentage of stroke |  | 12 months | 
| Percentage of systemic embolism |  | 12 months | 
| Percentage of myocardial infarction |  | 12 months | 
| Percentage of major bleeding |  | 12 months | 
| Percentage of electrical cardioversion |  | 12 months | 
| Percentage of percutaneous ablation of AF |  | 12 months | 
| Percentage of atrioventricular junction ablation |  | 12 months | 
| Percentage of patients that need of pacemaker implantation |  | 12 monts | 
| Percentage of other cardiovascular hospitalization |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Atrial Fibrilation, Antithrombotic therapy, Atrial Flutter
Men's Experience of Prostate Biopsy

Study Overview
=================
Brief Summary
-----------------
Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital may be invited to take part in one to one interview within 6 months of having the procedure done to talk about their experience

Detailed Description
-----------------
Men aged over 18 having a first or second diagnostic prostate biopsy at the Royal Marsden NHS Foundation Trust or Epsom General Hospital will be approached by their Urology team or study Researcher with an information sheet about the study pre or post biopsy. The participant information sheet outlines that the study will involve being interviewed by the researcher, Kathryn Myhill as part of her doctoral research and being asked about their perceptions of their biopsy experience and what it was like to go through it. Men who return an expression of interest reply slip by post will be contacted by the researcher or they can contact her directly via the email or phone details given in the PIS. The researcher will answer any queries about the study and explore whether they would like to take part in an interview. A one to one interview will then be offered in a non-clinical, private room at the hospital where their biopsy took place (Royal Marsden Hospital, Epsom General Hospital) or at their workplace or home.

Official Title
-----------------
Managing the Experience of Prostate Biopsy: What Are Men's Perceptions of Their Lived Experience and Support Needs

Conditions
-----------------
Prostate Biopsy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men aged over 18 having a first or second diagnostic prostate biopsy at either the Royal Marsden NHS Foundation Trust or Epsom General Hospital Within 6 months of their prostate biopsy being done Exclusion Criteria: Men unable to give informed consent/ men needing a translator

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

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

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 |
| --- | --- | --- |
| To review the experience of prostate biopsy | Qualitative evaluation of biopsy experience | two years |
Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy

Study Overview
=================
Brief Summary
-----------------
This is a single center, double-blind, randomized controlled trial evaluating the change in sexual function in women undergoing vaginal repair for pelvic organ prolapse. Participants will be sexually active women who agree to randomization to having perineorrhaphy added to or excluded from their surgical repair. We hypothesize that sexual function will improve more significantly in women undergoing vaginal repair with perineorrhaphy.

Official Title
-----------------
Evaluating Sexual Function After Vaginal Repair With Perineorrhaphy

Conditions
-----------------
Sexual Function

Intervention / Treatment
-----------------
* Procedure: Perineorrhaphy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: sexually active genital hiatus measured between 4 and 6 centimeters desires sexual function undergoing vaginal repair with native tissues agrees to use vaginal estrogen for 12 months after surgery Exclusion Criteria: genital hiatus > 6 cm planned obliterative procedure perineal body length <0.5cm disrupted external anal sphincter

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 105 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No perineorrhaphy<br>Subjects will not have a perineorrhaphy procedure added to the vaginal prolapse repair | |
| Active Comparator: Perineorrhaphy<br>Subjects will have a perineorrhaphy added to the vaginal repair of prolapse | Procedure: Perineorrhaphy<br>* Procedure to build up the vaginal opening<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in sexual function as measured by validated questionnaire | Validated questionnaires will be administered prior to surgery, as well as at intervals after surgery. | 6 months and 12 months after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prolapse recurrence | A composite outcome score to define success of prolapse surgery will be applied to subjects at 6 and 12 months specifically looking for return of prolapse symptoms, anatomic recurrence, and need for retreatment | 6 months, 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
vaginal prolapse, sexual function, sexual dysfunction, prolapse surgery
Study of Dasatinib in Patients With Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of Segment 1 of the study is to determine the effect of ketoconazole on dasatinib. The purpose of Segment 2 is to learn how dasatinib affects tumor growth in patients with advanced solid tumors.

Official Title
-----------------
Phase I Study to Evaluate the Effect of Ketoconazole on the Pharmacokinetics of Dasatinib and the Effect of Dasatinib on Pharmacodynamic Markers in Patients With Advanced Solid Tumors

Conditions
-----------------
Tumors

Intervention / Treatment
-----------------
* Drug: Dasatinib + Ketoconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ECOG status 0-2 Advanced or metastatic disease, unresponsive to standard treatment (or no standard treatment exists) Biopsy pretreatment Adequate bone marrow, liver and kidney function Exclusion Criteria: Serious cardiovascular disease Bleeding disorders Gastrointestinal (GI) tract disease Platelet inhibitors H2 blockers, proton pump inhibitors

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Dasatinib + Ketoconazole<br>* Tablets, Oral, Segment 1: escalating single dose of dasatinib starting at 140 mg q24 hours on Day 1-8; single dose of ketoconazole 200 mg q12 hours on Days 3-8; Segment 2: single daily oral doses of dasatinib, once daily, until disease progression or unacceptable toxicity.<br>* Other names: Sprycel;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Segment 1: Determine whether the steady state pharmacokinetics of 20 mg of dasatinib are affected by co-administration with ketoconazole in patients with advanced solid tumors |  |  | 
| Segment 2: Assess the pharmacodynamic activity of dasatinib |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Segment 1: Evaluate the safety and tolerability of dasatinib alone and when co-administered with ketoconazole |  |  | 
| Segment 2: Explore the association between tumor response and the pre-clinically identified markers and other mRNA gene expression level |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Advanced Solid Tumors
Effects of Male-specific Antibodies on Sex Ratio

Study Overview
=================
Brief Summary
-----------------
Investigation of the ability of antibodies from vasectomized men in binding to Y-spermatozoa as a possible explanation of the lower sex ratio observed after microinsemination using epididymal sperm from vasectomized men.

Conditions
-----------------
Sperm Antibodies, Sex Ratio

Intervention / Treatment
-----------------
* Other: Antibody-sperm binding


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Vasectomized men Exclusion Criteria: Men who do not understand the study information

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Antibody-sperm binding|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Y/X sperm ratio after exposure to sperm-specific antibodies |  | Up to 28 months |