linjc16/ctgov huggingface dataset:
Trial of the PresView Implant for the Improvement of Near Vision in Presbyopic Patients

Study Overview
=================
Brief Summary
-----------------
Study to determine the effectiveness of the PresVIEW Scleral Implant to improve near vision in patients who require reading glasses

Official Title
-----------------
A Prospective, Multicenter, Controlled Clinical Study of the PresVIEW Scleral Implant for the Improvement of Near Visual Acuity in Presbyopic Patients

Conditions
-----------------
Presbyopia

Intervention / Treatment
-----------------
* Device: PresVIEW Device Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 45 or older at commencement of study Best Corrected Distance Visual Acuity of .80 (20/25) or better Patients must be alert, mentally competent, and able to comply with clinical study requirements Exclusion Criteria: Any previous eye surgeries including cataract, LASIK (laser in situ keratomileusis), or eye muscle surgery Any chronic systemic diseases such as diabetes, heart disease, Lupus, etc. Any eye diseases such as eye inflammation, infection, cataract, or retinal diseases

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 60 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Randomized/Control<br>7 patients randomized to deferred treatment/control cohort at the 3 sub-study control sites = 21 | |
| Experimental: Non-Randomized/Treatment<br>Patients are non-randomized and if meet inclusion criteria receive the implantation of the PresVIEW device | Device: PresVIEW Device Implantation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near Visual Acuity | Measurement of the distance Corrected Near Visual Acuity at 40 centimeters compared to baseline measurement. A minimum of 75% of patients with a bilateral post-operative Distance Corrected Near Visual Acuity of .5 (20/40) or better at 12 months | 12 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected Near Visual Acuity | The percent of patients with a bilateral post-operative uncorrected near visual acuity (UCNVA) at 40 centimeters of .5 (20/40) or better at 12 months | 12 Months | 
| Presence of Significant Safety Events | Several indicators of safety are monitored including but not limited to Best Corrected Distance Visual Acuity, Intra-ocular Pressure, and Chronic Inflammation. | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Presbyopia, Reading Glasses, Near Vision
Treatment of Basal Cell Carcinomas With Methyl Aminolevulinate and Daylight

Study Overview
=================
Brief Summary
-----------------
Photodynamic Therapy (PDT) is an effective treatment of basal cell carcinomas (BCC) however the inconvenience of clinic attendance and discomfort during therapy are significant drawbacks. The objective of this study is to evaluate the effect of daylight-mediated PDT of BCC.

Official Title
-----------------
Treatment of Basal Cell Carcinomas With Methyl Aminolevulinate and Daylight

Conditions
-----------------
Photodynamic Therapy, Basal Cell Carcinomas

Intervention / Treatment
-----------------
* Procedure: Daylight mediated photodynamic therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: superficial BCC Exclusion Criteria: Immunosuppression

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Daylight-PDT<br> | Procedure: Daylight mediated photodynamic therapy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complete disappearance of the BCC |  |  |
Study Evaluating Pantoprazole in Peptic Ulcer Hemorrhage

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, randomized, double-blind, parallel-group, dose-ranging, comparator-controlled study of the effect of pantoprazole on intragastric pH after successful endoscopic hemostasis in hospitalized patients. Patients will receive either intravenous pantoprazole (one of two regimens) or ranitidine (the comparator) within 2 hours of successful hemostasis and administration will continue for 72 hours after hemostasis.

Official Title
-----------------
A Randomized Study of the Effect of Intravenous Pantoprazole on Gastric pH After Successful Hemostasis in Patients With Bleeding Peptic Ulcer

Conditions
-----------------
Peptic Ulcer Hemorrhage

Intervention / Treatment
-----------------
* Drug: Pantoprazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must be men or nonpregnant women at least 18 years of age Patients who present with a gastric or duodenal ulcer (major dimension of the ulcer must be ≥ 5 mm and ≤ 20 mm) with endoscopic appearance of spurting, oozing, or nonbleeding visible vessel (NBVV) Patients presenting with adherent protruding clot are eligible if, after removal of the clot by irrigation, the underlying lesion is classified as spurting, oozing or a NBVV. Patients with an actively bleeding ulcer or a NBVV within a hiatal hernia are eligible if the ulcer is located below the Z-line) Exclusion Criteria: Patients with ulcer appearance of clean base (non-oozing, non-spurting) or flat pigmented spot; adherent clots not removed by irrigation Patients presenting with active bleeding and/or NBVV at 2 or more separate sites Patients with any severe concomitant diseases, eg, end-stage liver or renal disease, or unstable cardiovascular, pulmonary, renal, hepatic, or gastrointestinal diseases

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: Prevention
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pantoprazole|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
-----------------
Peptic, Ulcer, Hemorrhage
Outcome After Lumbar Epidural Steroid Injection

Study Overview
=================
Brief Summary
-----------------
prospectively validate a fibronectin-aggrecan complex as a biomarker for response to ESI for radiculopathy with HNP

Detailed Description
-----------------
We will measure levels of the protein complex in the epidural space of patients undergoing lumbar ESI for radiculopathy with HNP. We assess functional outcomes at baseline and after treatment with the Medical Outcomes Study Short Form-36 instrument (SF-36). Our hypothesis was that the complex is present in patients with clinically significant functional improvement after ESI.

Official Title
-----------------
Functional Outcome After Lumbar Epidural Steroid Injection

Conditions
-----------------
Disc Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute onset of sensory symptoms with the primary complaint as pain as well as varying sensory symptoms (e.g. tingling, numbness) in one or more lumbar nerve root distributions Positive physical exam findings including sensory findings consistent with a spinal nerve root, a positive straight leg raise test, and/or a diminished patellar or Achilles DTR consistent with sensory symptoms; AND MRI of lumbar spine positive for HNP in a distribution correlating with physical examination Exclusion Criteria: Plain radiography demonstrating severe loss of disc height, high grade DDD, spondylolisthesis greater than grade I A history of prior lumbar surgery or trauma, weakness in a consistent distribution (non-progressive with strength at least 4/5) Red flags including progressive weakness, bowel/bladder complaints, radiographic unknown mass, unexpected weight loss; AND Diagnosis of inflammatory arthritides, crystalline arthropathies, or other rheumatologic diseases

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- | --- |
| functional outcome on SF-36 following ESI |  | 2-6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarker, epidural steroid, radiculopathy, hnp
Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project

Study Overview
=================
Brief Summary
-----------------
The primary objective is to create a multicenter registry which captures information relating to the perioperative anesthesia course and management of children undergoing anterior cruciate ligament reconstruction and to examine practice patterns and incidence of complications. Data from any single institution involved in this registry will be used for local safety and quality improvement efforts. In addition data from each institution can be compared to the information from the entire group of institutions participating in the project, thus providing a measure for comparison with national practice. The aggregate multi-institutional data set will be used to develop quality benchmarks for national safety and quality improvement efforts and best practice recommendation. We believe that this registry can also demonstrate how web based data collection can be used to evaluate clinical anesthesia outcomes for surgeries with a low incidence of critical events but with significant variability in medical management.

Detailed Description
-----------------
This multi institutional registry will capture data relating to perioperative practices and complications, some of which may be relatively infrequent. The goal of this group is to create this registry to be used for local safety and quality improvement and multi-center benchmarking in this population. Reports generated from the registry will provide individual institutions with comparative data showing how their site performs compared to composite averages from all participating sites. Queries of the composite data set may allow for identification of factors associated with improved outcomes in this population. Future queries of the data-base for research purposes will require approval of the participating members of SPAIN.

Official Title
-----------------
Society for Pediatric Anesthesia Improvement Network- Anterior Cruciate Ligament Reconstruction Outcomes Project

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females ages 12 years to 17.5 years Patients undergoing scheduled surgical procedures on the anterior cruciate ligament construction surgery in a hospital setting or surgical day center. Exclusion Criteria: Incarcerated subjects Non-English speaking families and subjects

Ages Eligible for Study
-----------------
Minimum Age: 12 Years
Maximum 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 |
| --- | --- | --- |
| Registry Creation | The development of a multi-center registry of all anterior cruciate ligament reconstruction performed in the pediatric population with anterior cruciate ligament tear. | 2 years |
TopQ Cut-Off Determination Study

Study Overview
=================
Brief Summary
-----------------
To determine optimal cut-off value for TopQ cut-off.

Official Title
-----------------
TopQ Cut-off Determination Study

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: No known ocular pathologies Exclusion Criteria: Any known ocular pathologies

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Thickness |  | Day 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Normal Eyes
Psychological Effects of Bone Marrow Transplants in Children

Study Overview
=================
Brief Summary
-----------------
This study is designed to examine the psychological effects of bone marrow transplants on children and their families. The investigators hypothesis is that families who show signs of psychological distress before transplant will continue those signs post transplant. The investigators are examining cognitive placement, emotional placement and other psychological factors in both the child undergoing transplant and his or her parent.

Detailed Description
-----------------
Previous research on bone marrow transplants has conflicting results concerning the effects of maladjustment. The current research is conducted in consortium with DeVos Children's Hospital. Children receiving bone marrow transplants are assessed using the Child Behavior Check List (CBCL) and Cognitive based testing. Parents are assessed using the Parenting Stress Index (PSI). Children and parents are evaluated prior to transplant and then 50 days, 6 months, and one year post transplant. Descriptive statistics are currently being used to determine results.

Official Title
-----------------
Proposal for a Bone Marrow Transplant Pre, Post, and Long Term Psychological Evaluation Study.

Conditions
-----------------
Psychological

Intervention / Treatment
-----------------
* Behavioral: protein and calorie controlled diet and self-hypnotic relaxation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bone marrow transplant eligible patients 18 years and under male and female Exclusion Criteria: over the age of 18

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 18 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: protein and calorie controlled diet and self-hypnotic relaxation|daily|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The specific measure that will be used to determine the effect of the intervention(s). The description should included the time at which the measure will be taken. Examples: all cause mortality at one year; score on a depression rating scale at 6 weeks |  | 1 year post transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other measures that will be used to evaluate the intervention(s), and that are specified in the protocol. The description should include the time at which the measures will be taken. Ex. cardiovascular mortality at 6 mos.; functional status at 4 wks |  | 1 year post transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bone Marrow, Bone Marrow Transplant, Pediatric, Psychological Impact, Psychology
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to collect EEG data with the Masimo SedLine device along with vital signs, patient demographics, anesthetic record and surgical procedure during general anesthesia or sedation.

Official Title
-----------------
SedLine Engineering Data Collection Study in Pediatric Patients Undergoing General Anesthesia or Sedation

Conditions
-----------------
Anesthesia

Intervention / Treatment
-----------------
* Device: Pediatric SedLine forehead EEG sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 17 years old and younger ASA status I, II, or III. Scheduled for surgical and non-surgical procedures scheduled under general anesthesia or sedation (Common procedures include but are not restricted to tonsillectomy, adenoidectomy, urological procedures, dental rehabilitation, orthopedic procedures, biopsies, audiogram, nuclear scans, gastroscopy, colonoscopy, etc. Surgery can be open, laparoscopic, or robotic). Exclusion Criteria: Any deformities or devices that may prevent application of SedLine Array to forehead with a proper fit. Cases in which a rapid sequence induction is indicated (emergency, full stomach precautions). Subjects who are developmentally delayed. Subjects deemed not suitable for study at the discretion of the investigator.

Ages Eligible for Study
-----------------
Minimum Age: 12 Months
Maximum Age: 17 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 |
| --- | --- |
| Experimental: Test Group<br>The subjects will be enrolled in the test group and will receive the Pediatric SedLine forehead EEG sensor. | Device: Pediatric SedLine forehead EEG sensor<br>* Pediatric EEG sensor.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants For Whom the EEG Data Collection Was Completed | EEG signals will be collected using SedLine sensor for product development under different anesthesia and sedation conditions. | Duration of surgery |
Does Exercise and Heat Increase the Lightsensibility in Patients With Erythropoietic Protoporphyria

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to evaluate the effect of exercise and heat on the light sensibility of patients with erythropoietic protoporphyria

Conditions
-----------------
Erythropoietic Protoporphyria

Intervention / Treatment
-----------------
* Behavioral: exercise
* Behavioral: heat
* Procedure: red light illumination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: erythropoietic protoporphyria, age 14 to 70. - Exclusion Criteria: Not able to exercise

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 70 Years

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: exercise|nan|
|Behavioral: heat|nan|
|Procedure: red light illumination|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
SMILE Trial - Imaging Sub-Study

Study Overview
=================
Brief Summary
-----------------
This is a pilot sub-study of an ongoing trial comparing N2O to midazolam in MDD and will examine neuroimaging correlates of treatment response.

Detailed Description
-----------------
Magnetic resonance imaging (MRI) scans of MDD-affected brains have revealed changes in structural and functional connectivity compared to healthy subjects. This pilot sub-study examines structural and functional connectivity associated with MDD-affected patient participants' responsiveness to N2O compared to the midazolam placebo, which induces similar sedative effects. The investigators intend to address the changes in brain functional activity and connectivity between baseline and after a four-week intervention course involving weekly nitrous oxide inhalations measured by MRI.

Official Title
-----------------
Sustained Mood Improvement With Laughing Gas Exposure: A Randomized Controlled Pilot Trial - Sub-Study Protocol to Include Neuroimaging

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Nitrous oxide gas for inhalation
* Drug: Midazolam injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eligible for main nitrous oxide (SMILE) study Exclusion Criteria: Contraindication for undergoing MRI scans (e.g., hip circumference < 180 cm or metal in the body)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental group<br>Participants assigned to this intervention arm in the main study will have been administered nitrous oxide at an inspiratory concentration of 50% with concurrent intravenous saline (100mL) for one hour. | Drug: Nitrous oxide gas for inhalation<br>* This sub-study does not have an intervention and based on the main study the participants who have received N2O will be compared with the midazolam placebo group.<br>* Other names: Nitrous oxide at an inspiratory concentration of 50% with concurrent intravenous saline (100mL);|
| Placebo group<br>Participants assigned to this intervention arm in the main study will have been administered 50% oxygen with intravenous midazolam (0.02mg/kg in 100mL) for one hour. | Drug: Midazolam injection<br>* This sub-study does not have an intervention and based on the main study the participants who have received N2O will be compared with the midazolam placebo group.<br>* Other names: 50% oxygen with intravenous midazolam (0.02mg/kg in 100mL);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain functional activity and connectivity | Changes in brain functional activity and connectivity between baseline and after 4 weeks of receiving the intervention, measured by MR imaging. | 4 weeks from the baseline visit |