linjc16/ctgov huggingface dataset:
The Effect Of Preoperative Parameters On Success After DMEK Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate the effect of preoperative parameters on surgical results in Descemet Membrane Endothelial Keratoplasty (DMEK) surgery.

Detailed Description
-----------------
In patients undergoing Descemet Membrane Endothelial Keratoplasty (DMEK) surgery; preoperative anterior chamber depth, angle parameters, axial length and corneal parameters will be evaluated. The effects of these parameters on surgical results will be examined.

Official Title
-----------------
The Effect Of Preoperative Anterior Segment Parameters On Success After Descemet Membrane Endothelial Keratoplasty (Dmek) Surgery

Conditions
-----------------
Fuchs' Endothelial Dystrophy, Pseudophakic Bullous Keratopathy, Descemet's Membrane; Defect, Herpetic Keratitis, Angle's Classification, Endothelial Dysfunction

Intervention / Treatment
-----------------
* Procedure: Descemet membrane endothelial keratoplasty (DMEK)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled to undergo Descemet membrane endothelial keratoplasty(DMEK) aged 18 old older Exclusion Criteria: Patients with corneal pathology other than endothelial insufficiency Glaucoma patients, Patients who have previously had any keratoplasty procedure

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 |
| --- | --- |
| Cohort<br>All patients | Procedure: Descemet membrane endothelial keratoplasty (DMEK)<br>* All participants underwent DMEK surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity | Change from baseline | Baseline and after surgery 1, 3, 6, and 12 months | 
| Change in endothelial cell density | Change from baseline | after surgery 1, 3, 6, and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in maximum (steepest) and minimum (flattest) keratometry values in the central corneal zone | Change from baseline | Baseline and after surgery 1, 3, 6, and 12 months | 
| Change in anterior chamber depth | Change from baseline | Baseline and after surgery 1, 3, 6, and 12 months | 
| Change in axial length | Change from baseline | Baseline and after surgery 1, 3, 6, and 12 months | 
| Change in central pachymetry | Change from baseline | Baseline and after surgery 1, 3, 6, and 12 months | 
| Change in intraocular pressure | Change from baseline | Baseline and after surgery 1, 3, 6, and 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Descemet Membrane, anterior chamber depth, axial length, endothelial count, Descemet membrane endothelial keratoplasty
Influence of Thoracolumbar Proprioceptive Support in the Segmental Stabilization Training

Study Overview
=================
Brief Summary
-----------------
Proprioceptive training has been shown to be effective in increasing the efficiency of motor-sensory tissues that stabilize the trunk. The investigators hypothesis is that proprioceptive support do influence in the activation of the transversus abdominis muscle (TrA) during segmental stabilization training.

Official Title
-----------------
Influence of Thoracolumbar Proprioceptive Support in the Segmental Stabilization Training

Conditions
-----------------
Transversus Abdominis Activation

Intervention / Treatment
-----------------
* Other: Segmental trunk exercise associated with proprioception
* Other: Segmental trunk exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy subjects Exclusion Criteria: subjects with any kind of disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Thoracolumbar proprioception<br> | Other: Segmental trunk exercise associated with proprioception<br>* Proprioceptive exercise<br>|
| Experimental: Segmental Stabilization<br> | Other: Segmental trunk exercise<br>* Segmental trunk exercise<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activation of transversus abdominis | Activation of transverus abdominis will be assessed by the biofeedback pressure unit.Pressure biofeedback units consist of a combined inflation bulb connected to a pressure cell. | Two Weeks |
Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937

Study Overview
=================
Brief Summary
-----------------
This is a single-centre, open-label, non-randomised, single-period, single-dose study in healthy male subjects designed to assess the mass balance recovery, PK, metabolite profile and metabolite identification of [14C]-BLU-5937.

Official Title
-----------------
A Single Dose Study to Assess the Mass Balance Recovery, Absorption, Metabolism and Excretion of [14C]-BLU-5937 in Healthy Male Subjects After Oral Dosing

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

Intervention / Treatment
-----------------
* Drug: [14C]-BLU-5937


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy males Exclusion Criteria: History of clinically significant cardiovascular, renal, hepatic, chronic respiratory or gastrointestinal disease, neurological or psychiatric disorder,as judged by the investigator

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 65 Years

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

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

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>Single oral dose of [14C]-BLU-5937 | Drug: [14C]-BLU-5937<br>* Each subject will receive a single oral administration of [14C]-BLU-5937 capsule, in the fasted state.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mass balance recovery of total radioactivity in all excreta after a single oral dose of [14C]-BLU-5937 | Mass balance recovery of total radioactivity in all excreta by analysing the total radioactivity and metabolic profile in blood, urine and faeces samples. | 168 hour |
A Study to See Whether Two HIV Vaccines Are Safe and Can Prevent HIV Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to see whether an HIV vaccine, ALVAC vCP205, is safe and can prevent HIV infection. The vCP205 vaccine will be tested with another vaccine, gp160MN/LAI-2.

Detailed Description
-----------------
This study consists of 2 parts: Part A: Dose-escalation protocol using oligomeric gp160MN/LAI-2. Part B: Placebo-controlled, randomized, double-blind (within arm) study of vCP205 priming with gp160MN/LAI-2 boosting. Volunteers are followed for at least 1 year.

Official Title
-----------------
A Phase I, Dose-Ranging Trial of the Pasteur Merieux Connaught (PMC) Oligomeric HIV-1 gp160MN/LAI-2 Vaccine Alone or Primed With Live Recombinant ALVAC-HIV (vCP205) in HIV Seronegative Adults

Conditions
-----------------
HIV Infections, HIV Seronegativity

Intervention / Treatment
-----------------
* Biological: gp160 MN/LAI-2
* Biological: ALVAC-HIV MN120TMG (vCP205)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria Volunteers may be eligible for this study if they: Are HIV-negative. Are in good health. Are between ages 18 and 55. Are available for at least 1 year. Are a resident of the United States of America. Agree to practice sexual abstinence or use birth control. Exclusion Criteria Volunteers will not be eligible for this study if they: Have ever been given an HIV vaccine or certain other vaccines. (However, rabies vaccines are allowed.) Participate in activities that place them at high-risk for HIV infection, such as injection drug use or unprotected sex with someone who has HIV infection. Have certain psychiatric, medical, or substance abuse problems. Are allergic to eggs or other vaccines. Are an employee at a participating site and have access to study information. Are taking certain medications. Have received blood transfusions within 3 months before entering this study. Are pregnant or breast-feeding.

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: Prevention
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: gp160 MN/LAI-2|nan|
|Biological: ALVAC-HIV MN120TMG (vCP205)|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
-----------------
Vaccines, Synthetic, Viral Vaccines, HIV-1, Dose-Response Relationship, Drug, HIV Envelope Protein gp160, AIDS Vaccines, HIV Seronegativity, Avipoxvirus, Immunization, HIV Envelope Protein gp120, Recombination, Genetic
Study Evaluating Anxiety and Depression in Patients With Psoriatic Arthritis

Study Overview
=================
Brief Summary
-----------------
This is an epidemiological non-interventional study assessing the prevalence of anxiety and/or depression disorders in patients suffering from Psoriatic Arthritis (PsA) in Spain.

Official Title
-----------------
Anxiety and Depression in Patients With Psoriatic Arthritis: Prevalence and Characteristics

Conditions
-----------------
Psoriatic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Patients both genders over 18 years old Patients with PsA diagnosis Exclusion criteria: Patients with PsA that suffer from other rheumatologic diseases or non-concomitant rheumatologic diseases that the investigator considers not to be appropriate for the study. Patients with any medical or physical condition (cognitive damage or difficulties for understanding) that create difficulties for reading and completing the questionnaires described in the protocol. Patients that in the study period are taking part in another clinical trial.

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 |
| --- | --- |
| 1<br>Patients with PsA that fulfill the eligibility criteria of the study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of anxiety and/or depression disorders in patients suffering from PsA in Spain as measured by the Hospital Anxiety and Depression Scale (HAD) |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the relation between the PsA severity and the presence of anxiety and/or depression disorders in patients suffering from PsA in Spain. |  | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Anxiety and depression in patients with psoriatic arthritis
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump.

Study Overview
=================
Brief Summary
-----------------
This study aims at describing the glucose level by automated glucose sensors and correlating it with insulin delivery and meals over 14 days in insulin-requiring T2D patients living in real-life conditions.

Official Title
-----------------
Real-Life Home Glucose Monitoring Over 14 Days in T2D Patients With Intensified Therapy Using Insulin Pump. The CLOSE Study

Conditions
-----------------
Type 2 Diabetes Mellitus

Intervention / Treatment
-----------------
* Device: Continuous Glucose Monitoring (CGM)


Participation Criteria
=================
Eligibility Criteria
-----------------
Selection criteria: Type 2 Diabetes diagnosed for at least 5 years Treated with insulin pump for at least 6 months 7.5% ≤ HBA1c ≤ 10% (last available value dated less than 3 months) Having given his/her free, express and informed consent to participate to the study Inclusion Criteria: 7.5% ≤ HBA1c ≤ 10% (result of the dosage performed at selection visit) Daily insulin requirement ≤ 1.5U/kg/day Having been compliant to take pictures of his/her meals and snacks over the 3 days prior to the inclusion visit Non-selection/Non-inclusion criteria: Pregnant or breastfeeding woman Comorbidity which, in the investigator's opinion, could jeopardize the study completion Patient with difficulties to understand the study procedures or deemed unfit, by the Investigator, to comply with operating instructions of CGM equipment.

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Continuous Glucose Monitoring (CGM)<br>DEXCOMG4 device for 14 days | Device: Continuous Glucose Monitoring (CGM)<br>* DEXCOMG4 device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Relationships between glucose levels and insulin doses | To describe the relationships between glucose levels and insulin doses between meals and at meal-times in T2D patients using pumps over 14 days. | 14 days |
An Evaluation of Root Length Measurements Using Intraoral Scan and Panoramic Radiographs

Study Overview
=================
Brief Summary
-----------------
This study will attempt to validate a method of estimating root length on panoramic radiograph by crown measurement on intraoral digital scans.

Detailed Description
-----------------
Intraoral digital scans will be taken on patients who have completed orthodontic treatment, and measurements will be made on the crown dimensions. These dimensions will then be applied onto the same teeth as seen on panoramic radiographs and a mathematical relationship will be determined for root length. Changes in root length will be measured from initial records to treatment complete panoramic radiographs and these estimates will be compared to actual root length changes as measured in CBCT (Cone Beam Computed Tomography) records.

Official Title
-----------------
An Evaluation of Root Length Measurements Using Intraoral Scan and Panoramic

Conditions
-----------------
Root Resorption

Intervention / Treatment
-----------------
* Other: Intraoral Scan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has initial records including CBCT scan and panoramic radiograph that are clear. Subject must have no restorations or significant loss in tooth structure in target teeth or teeth adjacent to target. Exclusion Criteria: Subjects who have records that are not clear, and who are missing target teeth.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 55 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 |
| --- | --- |
| Experimental group<br>All patients who have initial and final records qualify in the experimental group. | Other: Intraoral Scan<br>* All patients will have an intraoral scan performed for measurements to be taken on.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in root length in mm | Changes in root length will be calculated, starting from the initiation of orthodontic treatment to completion of treatment, at an average of 24 months. | Root length will be measured at the initiation of orthodontic treatment and at an average of 24 months later. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Root Resorption, Panoramic Radiograph
Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis

Study Overview
=================
Brief Summary
-----------------
Enbrel was first approved as new medicine on 06 Oct 2003 in Korea and the indication of Pediatric Psoriasis was approved on 23 Sep 2009. However, as required for any new indication approved by Korea Food and Drug Administration (KFDA), safety and efficacy information of new indication should be provided at minimum 600 subjects administered in the setting of routine practice during the initial 4 years after new indication approved.

Detailed Description
-----------------
All patients enrolled should meet the usual prescribing criteria for Enbrel in psoriasis as per the local product information for usage.

Official Title
-----------------
Post Marketing Surveillance To Observe Safety And Efficacy Of Enbrel In Pediatric Patients With Psoriasis

Conditions
-----------------
Pediatric Psoriasis

Intervention / Treatment
-----------------
* Drug: Enbrel group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children and adolescents aged 8 years to 17 years at time of consent Chronic severe psoriasis patients who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies Exclusion Criteria: Patients with known hypersensitivity to Enbrel or any component of the product Patients with active infections including chronic or localized infections such as tuberculosis (Treatment of Enbrel should not be initiated)

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 17 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 |
| --- | --- |
| Enbrel<br>The patients who are prescribed Enbrel for pediatric psoriasis | Drug: Enbrel group<br>* will be decided by treating physicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measured by discontinuation due to adverse events |  | 6 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects achieving a status on the PGA (Physician's Global Assessment) of psoriasis of clear (0), clear/almost clear (0/1), or clear/almost clear/mild (0/1/2) at 12 weeks and 24 weeks |  | 6 month | 
| Proportion of subjects achieving a 50% and 75% improvement from baseline in PASI (Psoriasis Area-and-Severity Index) over 12 weeks and 24 weeks |  | 6 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric psoriasis, enbrel, safety, efficacy
Using an iPhone ECG to Monitor the QT Interval on Dofetilide and Sotalol Patients

Study Overview
=================
Brief Summary
-----------------
This study will validate the recording accuracy of a specific electrical interval of the heart, the QT interval, between an iPhone rhythm strip recording and a traditional 12-lead electrocardiogram (ECG). These measurements will occur in hospitalized patients that are starting either sotalol or dofetilide, since both of these medications can prolong the QT interval.

Detailed Description
-----------------
Patients that were already selected to begin either dofetilide or sotalol in the hospital, will be included in the study. Patients will receive an ECG before and 2 hours after each dose of the medication, which is done to monitor the QT interval. In addition, patients that consent to participate in the study will have an iPhone ECG recording taken in lead positions that correspond to leads I,II, and III. These recordings will be compared and analyzed to assess the accuracy of the QT interval recordings between the two methods.

Official Title
-----------------
Clinical Validation of an iPhone ECG System, QT Substudy

Conditions
-----------------
Cardiac Arrhythmia, Qt Interval, Variation in

Intervention / Treatment
-----------------
* Device: iPhone ECG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: initiation of sotalol or dofetilide inpatient at University hospital Exclusion Criteria: none

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: iPhone ECG QT recording<br>iPhone ECG | Device: iPhone ECG<br>* Please see detailed description for additional information.<br>* Other names: AliveCor iPhone ECG;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| QT interval measurement (in milliseconds) | The QT interval (measured from the start of the QRS to the end of the T wave) will be measured on the 12-lead ECG and on the iPhone rhythm strip recording. Both measurements will be recorded in milliseconds and will be statistically analyzed for bias and agreement. | Participants will be followed for duration of hospital stay during which dofetilide or sotalol are being started, an expected average of 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ECG, QT interval, Sotalol, Dofetilide, iPhone