linjc16/ctgov huggingface dataset:
Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

Study Overview
=================
Brief Summary
-----------------
to assess the near-term (12 months) efficacy of pulmonary vein isolation.

Detailed Description
-----------------
The aim of the study was to assess the near-term (12 months) efficacy of pulmonary vein isolation using a standard approach compared to application of an additional acute procedural endpoint of unexcitability along the ablation line.

Official Title
-----------------
Unexcitability Along the Ablation as an Endpoint for Atrial Fibrillation Ablation

Conditions
-----------------
Paroxysmal Atrial Fibrillation, Catheter Ablation Strategies

Intervention / Treatment
-----------------
* Device: catheter based pulmonary vein isolation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: written informed consent age > 18 years paroxysmal atrial fibrillation Exclusion Criteria: structural heart disease intracardiac thrombus reversible causes of atrial fibrillation inability to take warfarin

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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 |
| --- | --- |
| Active Comparator: Loss of pace capture<br>Pulmonary vein isolation: Ablation along the ablation line is continued until loss of pace capture along the ablation line is achieved catheter based pulmonary vein isolation | Device: catheter based pulmonary vein isolation<br>* catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice<br>|
| Active Comparator: Conventional<br>Pulmonary vein isolation: Ablation is discontinued when electrical isolation of the pulmonary veins is achieved. catheter based pulmonary vein isolation | Device: catheter based pulmonary vein isolation<br>* catheter based ablation using irrigated catheters and radiofrequency energy as in clinical practice<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to AF and AT recurrence | recurrence of AF as assessed by 3 day holter monitoring, assessment of AT recurrence using 3 day holter monitoring | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| procedure duration | time needed to complete the procedure | completed (15 months) | 
| procedure safety | complication such as groin hematoma, stroke and pericardial bleed prolonging the hospital stay will be assessed | up to three days after the procedure |
The Out-patient, Non Antibiotic Management of Patients With Acute Uncomplicated Colonic Diverticulitis

Study Overview
=================
Brief Summary
-----------------
Previous multicentre study NCT 01008488 indicates that a patient with CT-proven uncomplicated diverticulitis has a very low risk (1.4%) of developing severe complications such as perforations or abscesses. The question is whether or not hospitalization is necessary, and if patients in that case could return home without antibiotics. The purpose of this study is to evaluate if out-patients managements in uncomplicated colonic diverticulitis is possible without readmission or complications.

Detailed Description
-----------------
At the emergency room all patients with computed tomography verified acute uncomplicated diverticulitis will be asked about participation in the study. If They accept the participation, They will be send home with pain relief medicine. Every morning a nurse from our colorectal unit call the patient asking about the condition. The patients will have a visit at the surgery unit within 10 days.

Official Title
-----------------
Management of Patients With Uncomplicated Diverticulitis as Out-patient and Without Antibiotics

Conditions
-----------------
Colonic Diverticulitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (age above 18 years, acute abdominal pain (Duration< 3 days), abdominal tenderness, elevated inflammatory parameters, CT- scan sign of uncomplicated diverticulitis(without sign of abscess or free air). Exclusion Criteria: diffuse peritonitis sepsis or abscess, drying Patients who are unable to intake of fluids orally, severe pain with need of repeated parenteral morphine treatment, immunological deficient patients incl. steroid treatment, pregnancy, dementia, patients who need hospitalization of other reasons

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Out-patients in diverticulitis<br>All patient with acute uncomplicated diverticulitis how accept participation in the study will be enrolled in the study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of admission and complications among participant within three months follow-up. |  | Three months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate reason of hospital admission, late complications, need of bowel rest and costs |  | Three months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diverticulitis, Out-patient management, Antibiotics
Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)

Study Overview
=================
Brief Summary
-----------------
The objective of the Latella-2 study is to demonstrate the safety and efficacy of the Latella Knee Implant System for the reduction of medial osteoarthritis knee pain.

Official Title
-----------------
Evaluation of the Latella Knee Implant System for Medial Osteoarthritis Pain Reduction (Latella-2 Study)

Conditions
-----------------
Osteoarthritis

Intervention / Treatment
-----------------
* Device: Latella Knee Implant System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of pain due to medial osteoarthritis Qualifying baseline pain scores Kellgren-Lawrence Grades 2-3 Exclusion Criteria: Osteoporosis Rheumatoid arthritis Joint instability Metal ion allergy Permanent implant in or around the knee joint Prior anterior cruciate ligament reconstruction

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 70 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: Latella Knee Implant System<br> | Device: Latella Knee Implant System<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary Endpoint: Efficacy assessed by KOOS pain score at 6 months after treatment with the Latella Implant |  | 6 Months | 
| Primary Endpoint: Safety assessed by surgical re-intervention rate following implantation of the Latella device |  | 6 Months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in knee outcome measures (KOOS, IKDC, NRS) |  | 6, 12 and 24 months | 
| Device and procedure complication rates |  | 6, 12 and 24 months |
Wide-field Optical Coherence Tomography Imaging of Excised Breast Tissue.

Study Overview
=================
Brief Summary
-----------------
This is a single-arm, multi-center data collection study designed to collect WF-OCT imaging data of excised breast tissue margins with corresponding margin status from histopathology.

Detailed Description
-----------------
Data collected during this study will be used for product development by the study sponsor, Perimeter Medical Imaging.

Official Title
-----------------
A Prospective, Multi-center, Randomized, Double-arm Trial to Determine the Impact of the SELENE System on Positive Margin Rates in Breast Conservation Surgery.

Conditions
-----------------
Breast Cancer Female

Intervention / Treatment
-----------------
* Device: Investigational WF-OCT device


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female Age 18 years or older Invasive ductal breast carcinoma and ductal carcinoma in situ having undergone breast conservation surgery May include neo-adjuvant treated subjects (chemotherapeutic, endocrine therapy, or radiation) Ability to understand and the willingness to sign a written informed consent document Exclusion Criteria: Metastatic cancer (Stage IV) Lobular carcinoma as primary diagnosis

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| WF-OCT imaging of excised breast lumpectomy tissue<br>Excised lumpectomy tissue from all consented patients will be imaged on an investigational OCT-based device. No clinical decisions will be made based on the images acquired. | Device: Investigational WF-OCT device<br>* Excised lumpectomy tissue will be imaged on an investigational WF-OCT device<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WF-OCT image acquisition of excised lumpectomy tissue margins | This is a data collection study. The primary outcome is the collection of WF-OCT images of excised lumpectomy tissue margins. | 1 year |
Retinal Imaging Using NOTAL-OCT

Study Overview
=================
Brief Summary
-----------------
Comparison between retinal measurements, done by the Notal-OCT imaging and a commercial OCT (Optical Coherence Tomography)

Official Title
-----------------
Retinal Imaging Using NOTAL-OCT

Conditions
-----------------
Age-Related Macular Degeneration, Diabetic Retinopathy

Intervention / Treatment
-----------------
* Device: Notal OCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ability and agreement to give informed consent (IC) Diagnosis of AMD or DR in SE by OCT Ability to undergo OCT scans VA of 20/160 or better in SE Exclusion Criteria: AMD and DR in the same SE Evidence of macular disease other than AMD or DME in SE

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 |
| --- | --- |
| Intermediate AMD<br> | Device: Notal OCT<br>* Imaging using Notal OCT<br>|
| Advanced AMD<br> | Device: Notal OCT<br>* Imaging using Notal OCT<br>|
| DR without macular edema<br> | Device: Notal OCT<br>* Imaging using Notal OCT<br>|
| DR with macular edema<br> | Device: Notal OCT<br>* Imaging using Notal OCT<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The level of agreement between NOTAL-OCT and commercial OCT in detecting fluid in the 10 central degrees of the macula. | OCT B-scans from both devices will be graded for fluid by an eye care professional and results per macula will be analyzed. A binary decision there is fluid or there is no fluid will be given to each macula (10 central degrees). Then agreement between decisions, commercial and Notal OCT, will be compared | 1 year |
Nociplastic Pain Symptoms and Sensory Profiles in Low Back Pain

Study Overview
=================
Brief Summary
-----------------
Assessing associations between Sensory profiles and nociplastic pain symptoms, and assessing the prognostic value of sensory profiles in the development of nociplastic pain symptoms in a low back pain population.

Detailed Description
-----------------
Therefore, the investigators aims are: The primary aim of the study is to assess associations between Sensory Profiles (Adolescent/Adult Sensory Profiles) and Nociplastic pain Symptoms, in the acute and chronic low back pain population. The secondary aim is to assess the prognostic value of sensory profiles in the transition to central sensitisation and pain, in the acute and chronic low back pain population at twelve weeks.

Official Title
-----------------
Nociplastic Pain Measurement and Sensory Profiles in Patients With Acute and Chronic Low Back Pain: a Longitudinal Observational Cohort Study

Conditions
-----------------
Central Sensitisation, Low Back Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with non-specific LBP with or without radiating pain aged 18-65 years able to read and understand the Dutch language Exclusion Criteria: previous lumbar spinal surgery radiculopathy or any specific cause of low back pain such as lumbar spinal stenosis, current malignancy, spondyloarthropathy, osteoporosis, spondylolisthesis, major trauma, infection, or systemic disease.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Central sensitiszation QST | Quantitative sensory testing | 12 weeks follow-up | 
| Central senzitization CSI | Central sensitization inventory | 12 weeks follow-up | 
| Central sensitization PSQ | Pain sensitization questionnaire | 12 weeks follow-up |
Addressing Patients' Expectations of Total Knee Arthroplasty in a Randomized Trial

Study Overview
=================
Brief Summary
-----------------
The goals of this study are to develop and test an educational intervention to address patients' expectations of long-term outcomes of total knee arthroplasty.

Detailed Description
-----------------
The first goal of this study is to develop an educational intervention to address patients' expectations of long-term outcomes of total knee arthroplasty. The intervention will be structured according to the expectations listed in the Hospital for Special Surgery Total Knee Replacement Expectations Survey. The second goal is to test the intervention in a randomized trial. An additional goal is to compare patients' self-reported knee symptoms with radiographic findings.

Official Title
-----------------
Addressing Patients' Expectations of Total Knee Arthroplasty: Developing and Testing an Educational Intervention in a Randomized Trial

Conditions
-----------------
Knee Osteoarthritis, Arthroplasty, Replacement, Knee

Intervention / Treatment
-----------------
* Behavioral: Educational program to address patients' expectations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients will be eligible for this study if they are 40 years of age or older and are scheduled for primary total knee arthroplasty at the Hospital for Special Surgery. Exclusion Criteria: Patients will be excluded from this study for the following reasons: if they are not fluent in English; if they are not going to attend the preoperative knee replacement class; if they are unable to complete the surveys; if they refuse to participate.

Ages Eligible for Study
-----------------
Minimum Age: 40 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Educational program to address patients' expectations|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome is the within-patient change between pre and post program scores measured by the Hospital for Special Surgery Total Knee Replacement Expectations Survey. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary outcome is to compare patient-reported symptoms with radiographic ratings of disease activity. |  |  | 
| The secondary outcome is to determine if expectations after the class coincide more closely with orthopedic surgeons expectations |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
knee arthritis, total knee arthroplasty, expectations, education
Evaluation of RTVue XR With SSADA

Study Overview
=================
Brief Summary
-----------------
Optovue has implemented a motion contrast imaging software in RTVue XR, a split spectrum amplitude decorrelation algorithm (SSADA), for non-invasive imaging of ocular vasculature. Consented subjects will undergo a series of images of the back of the eye using an Optical Coherence Tomograpy (OCT) device, RTVue XR, in addition to the conventional images as part of clinical routine. SSADA images will be compared with conventional methods.

Official Title
-----------------
Clinical Evaluation of RTVue XR With SSADA in Retinal Patients

Conditions
-----------------
Retina Vascular Pathology

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >18 Able and willing to complete exams Patients in retina clinic that need angiography Exclusion Criteria: Unable to complete the required examinations and visits Large amount of subretinal hemorrhage Media opacity leading to poor quality images Extreme refractive error leading to poor quality images Pathologies in the anterior segment leading to poor quality images

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Agreement of SSADA to conventional angiography |  | Day 1 |
Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
Patients with newly diagnosed gestational diabetes will be recruited. The control group with get routine diet and exercise counseling. The intervention group will be instructed to get moderate-to-vigorous intensity exercise; they will walk on a treadmill one time with supervision in order to be instructed how hard to work. All participants will keep an exercise log for 3 weeks and will wear an accelerometer for 1 week. The primary outcome is glucose control, specifically the need for medication in treatment of their diabetes. The hypothesis is that moderate or greater intensity exercise will better control glucose and lead to less need for medication management.

Official Title
-----------------
Moderate-to-vigorous Physical Activity for Glycemic Control in Patients With Gestational Diabetes Mellitus: a Pilot Study

Conditions
-----------------
Gestational Diabetes Mellitus, Exercise

Intervention / Treatment
-----------------
* Behavioral: Moderate-to-vigorous intensity exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: gestational diabetes mellitus singelton pregnancy 18 years old or older no medical contraindications to exercise Exclusion Criteria: multiple gestation non-English speaking unable to exercise preexisting diabetes

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

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

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: Moderate-to-vigorous intensity exercise<br>Moderate-to-vigorous intensity exercise three times per day for three weeks | Behavioral: Moderate-to-vigorous intensity exercise<br>* Moderate-to-vigorous intensity exercise three times per day for three weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Need for medication for diabetes |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Birth weight |  | delivery | 
| A1c |  | delivery | 
| Mode of delivery |  | delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
GDM, A1GDM, A2GDM