linjc16/ctgov huggingface dataset:
Non-Invasive Imaging of the Human Eye

Study Overview
=================
Brief Summary
-----------------
Evaluate the clinical information obtained from the use of the machines.

Detailed Description
-----------------
Evaluate the clinical information provided by these devices and determine their clinical utility and efficacy and safety.

Official Title
-----------------
Non-Invasive Imaging of the Human Eye

Conditions
-----------------
Willing and Able Subjects for Ocular Imaging

Intervention / Treatment
-----------------
* Device: 3D OCT-1
* Device: 3D OCT-2000
* Device: DRI OCT-1
* Device: NW-300
* Device: CT-1P
* Device: TRK-2P
* Device: SP-1P
* Device: SL-D701
* Device: MC-4S


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients from 18 to 80 years old who have full legal capacity to volunteer on the date the informed consent is signed. Subjects who can follow the instructions by the clinical staff at the clinical site and can attend examinations on the scheduled examination date. Exclusion Criteria: History of ocular pathology. History of cataract of ocular surgical procedures that render the cornea opaque or otherwise impact its ability to be imaged using the investigational device. History of systemic disease fixation problems which may prevent obtaining good quality images in the eye.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Normal Healthy Eyes<br>Normal healthy eyes with no known ocular diseases | Device: 3D OCT-1<br>* Spectral Domain OCT Device<br>Device: 3D OCT-2000<br>* Spectral Domain OCT Device<br>Device: DRI OCT-1<br>* Swept Source OCT Device<br>Device: NW-300<br>* Fundus Camera<br>Device: CT-1P<br>* Tonometry<br>Device: TRK-2P<br>* Tonometry, Corneal Topography<br>Device: SP-1P<br>* Specular Microscopy<br>Device: SL-D701<br>* Slit Lamp Imaging<br>Device: MC-4S<br>* Visual Acuity Testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device Evaluation | Determine Clinical Utility, Efficacy, and Safety | 1 Hour |
Caudal Epidural Steroid Injections for Low Back Pain/Sciatic Lumbar Pain

Study Overview
=================
Brief Summary
-----------------
The study hypothesis is that caudal epidural steroid injections provides short term relief to patients with persistent low back pain and sciatica due degenerative disc disease or lumbar spinal stenosis. Patients will be evaluated wiht clinical examination and radiological examinations before injections. They will be followed up with questionnaires on pain and disability up to 6 months postinjection.

Official Title
-----------------
Efficacy Study of Caudal Epidural Steroid Injections in Patients With Low Back Pain/Radiculopathy

Conditions
-----------------
Pain, Disability

Intervention / Treatment
-----------------
* Procedure: caudal epidural steroid injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: low back pain and sciatica due to lumbar disc herniation or lumbar spinals stenosis Exclusion Criteria: infection, cancer, allergy to steroids or anesthetic, non controlled diabetes or hypertension, clotting disorder

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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

| Intervention/Treatment |
| --- |
|Procedure: caudal epidural steroid injection|injecting steroids in the epidural space via caudal route|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change from preinjection of oswestry disability index at 15 days and at 3-6 months postinjection |  | pre injection to 3-6 months postinjection | 
| change from preinjection of Visual Analogue Scale at 15 days and at 3-6 months postinjection |  | preinjection to 3-6 months postinjection |
Study Evaluating PSI-697 in Patients With Scleritis

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety of an orally administered single dose of PSI-697 in subjects with scleritis, as a model of inflammatory disease. To evaluate by in vivo confocal microscopy (IVCM) the effect of a single dose of PSI-697 on leukocyte rolling in the scleral blood vessels of subjects with scleritis.

Official Title
-----------------
An Exploratory, Double Blind, Placebo-controlled, Randomized, Single-dose, Cross-over, Proof of Mechanism Study of Orally Administered PSI-697 in Patients With Scleritis

Conditions
-----------------
Scleritis

Intervention / Treatment
-----------------
* Drug: PSI-697


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion: Age 18 or higher; A negative urine pregnancy test at screening for female subjects; Female subjects must be postmenopausal or surgically sterile. Exclusion: Isolated episcleritis; Isolated posterior scleritis; Infectious scleritis.

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

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: PSI-697|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate by IVCM the effect of a single dose of PSI-697 on leukocyte rolling in scleral blood vessels of subjects with scleritis. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Scleritis
Genotype-related Effects of PUFA

Study Overview
=================
Brief Summary
-----------------
To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism

Detailed Description
-----------------
To assess the bioefficacy of omega-3 fatty acids (provided by intake of fish oil supplements) depending on genotype of relevant factors in lipid metabolism.

Official Title
-----------------
Response to PUFA Intervention According to PPAR Genotypes

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

Intervention / Treatment
-----------------
* Dietary Supplement: Triple Strength Fish Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult between 18 and 40 years of age BMI between 18.5 and 30 kg/m2 Sedentary to moderate physical activity habits Exclusion Criteria: Concomitant treatment: Consumption of dietary supplements or any medication that can affect the study outcomes Actively smoking Suspected abuse of alcohol or illicit drugs Significant illness within the two weeks prior to study start or any active systemic infection or medical condition that may require treatment during the study Known or suspected medical condition related to coagulation Subject who cannot be expected to comply with the study procedures Currently participating or having participated in another clinical trial during the last 4 weeks prior to beginning of this study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Supplementation<br>Supplementation | Dietary Supplement: Triple Strength Fish Oil<br>* Triple Strength Fish Oil<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in triglyceride levels in plasma |  | Baseline and 6 weeks intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess bioefficacy of EPA and DHA supplementation | The bioefficacy will be evaluated by characterizing and measuring the effects on lipid metabolism, glucose metabolism and insulin resistance, and inflammatory response | Baseline and 6 weeks intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
volunteers
Comparison of NT Vs Body Weight Supported TT Along With CT on Lower Extremity in Chronic Stroke Patients

Study Overview
=================
Brief Summary
-----------------
To determine the effect of Neurodevelopment Treatment vs Body Weight Supported Treadmill Training along with conventional therapy on lower extremity among chronic stroke patients.

Official Title
-----------------
Comparison of Neurodevelopmental Treatment Vs Body Weight Supported Treadmill Training Along With Conventional Therapy on Lower Extremity Among Chronic Stroke Patients

Conditions
-----------------
Chronic Stroke

Intervention / Treatment
-----------------
* Diagnostic Test: Neurodevelopmental Treatment
* Diagnostic Test: Body weight supported treadmill training along with conventional therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Application of M-Cog test for checking patients cognition. Chronic ischemic stroke patients. Both Male and Female Patients. Patients of 35 or above years of age. Exclusion Criteria: Patients with history of recurrent stroke. Patients with lower limb fractures or dislocations. Patients with Peripheral vascular disease Patients with skin discoloration or skin ulcers.

Ages Eligible for Study
-----------------
Minimum Age: 35 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neurodevelopmental Treatment<br>Using Neurodevelopmental Treatment Method | Diagnostic Test: Neurodevelopmental Treatment<br>* Using Neurodevelopmental Treatment Method<br>|
| Experimental: Body weight supported treadmill training along with conventional therapy<br>Using Body weight supported treadmill training along with conventional therapy Method | Diagnostic Test: Body weight supported treadmill training along with conventional therapy<br>* Using Body weight supported treadmill training along with conventional therapy Method<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| For lower extremity among chronic stroke patients | comparison of neurodevelopmental treatment vs body weight supported treadmill training along with conventional therapy on lower extremity among chronic stroke patients | 6 Months |
Safety of Lumiracoxib in Patients With Osteoarthritis

Study Overview
=================
Brief Summary
-----------------
This safety study evaluated the incidence of gastrointestinal adverse events and edema in patients with osteoarthritis treated with lumiracoxib and rofecoxib as comparator

Official Title
-----------------
A 6-Week Multicenter, Randomized, Double-Blind, Double-Dummy, Active-Controlled Parallel Group Clinical Saftey Study to Evaluate Incidence of Predefined Gastrointestinal Adverse Events and Peripheral Edema in Subjects With Primary Osteoarthritis Treated With COX189 400 mg o-do Using Rofecoxib 25 mg o.d. as a Comparator

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

Intervention / Treatment
-----------------
* Device: lumiracoxib
* Drug: rofecoxib


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=50 years old Primary osteoarthritis in hip, hand, knee or spine for at least 3 month Pain in the target joint of moderate intensity Written informed consent Exclusion Criteria: Secondary osteoarthritis Active upper gastro intestinal tract ulceration Inflammatory joint disease Gout Clinically significant hepatic or renal disease Other in and exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Device: lumiracoxib<br>* 400 mg once daily, oral over 6 weeks<br>* Other names: Prexige;|
| Active Comparator: 2<br> | Drug: rofecoxib<br>* 25 mg, oral, daily over 6 weeks<br>* Other names: Vioxx;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of at least one of seven predefined gastrointestinal adverse events |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, lumiracoxib, rofecoxib, Cox-2, Osteoarthritis (primary osteoarthritis hip, hand, knee or spine (cervical or lumbar)
Comparison of Gamma Nail Versus Dynamic Hip Screw for the Treatment of Unstable Intertrochanteric Fractures

Study Overview
=================
Brief Summary
-----------------
The objective of the study is to examine the treatment of unstable Intertrochanteric fractures with the short Gamma nail, compared to the use of the dynamic hip screw (DHS). This is a prospective study. Sixty patients with unstable Intertrochanteric fractures will be randomized to be treated using either Gamma nail or DHS. The patients will be followed for 12 months. The primary endpoint is the clinical outcome as measured by the Merle d'Aubigne and Postelhip score.

Conditions
-----------------
Intertrochanteric Femoral Fractures

Intervention / Treatment
-----------------
* Device: Gamma-3 Nail
* Device: DHS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Acute Intertrochanteric fracture - A1-32 AO/OTA Abbreviated mental score >6 Community ambulator (pre-fracture state) Exclusion Criteria: Previous arthritis Pathological fracture Chronic corticosteroid use Concomitant lower extremity fractures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Experimental: Gamma-3 Nail<br> | Device: Gamma-3 Nail<br>* Gamma-3 Nail (stryker)<br>|
| Active Comparator: DHS<br> | Device: DHS<br>* DHS (Zimmer)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical outcome as measured by the Merle d'Aubigne and Postel hip score |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Intertrochanteric femoral fractures - unstable
Three-dimensional Assessment of Facial Alterations Induced by Dental Prostheses

Study Overview
=================
Brief Summary
-----------------
Validation of the use of a facial scanner for assessment of modifications caused by the use of dental prostheses and determination of discrepancies related to conventional measurements with digital caliper.

Detailed Description
-----------------
3 dimensional evaluation of lip support by the use of full arch impplant supported rehabilitations with the use of a facial scannner. Determination of discrepacies between the obtained facial scan and conventional measurements made by a digital caliper on the face.

Official Title
-----------------
Analysis of Three-dimensional Modifications Caused by Full Arch Implant Supported Dental Prosthesis With a Facial Scanner

Conditions
-----------------
Soft Tissue

Intervention / Treatment
-----------------
* Device: Facial scanner (Bellus3D) to assess perioral alterations


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients rehabilitated with full implant supported upper dental prostheses. Exclusion Criteria: Patients without beard, facial deformities, earrings or braces.

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: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: Determine the modifications caused by the use of different implant-supported dental prostheses in the soft tissues of the face, mainly upper and lower lips, by the use of a facial scanner.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patient with or without dental prostheses<br>The patient will be submitted to two facial scans, one with and another without the dental prostheses and the obtained datasets will be compared to assess the differences. Marks will be made in the face to allow for measurements (digital and conventional) | Device: Facial scanner (Bellus3D) to assess perioral alterations<br>* Use of a digital caliper for conventional measurements and a facial scanner (Bellus3D) to analyse the modifications induced by the use of implant supported dental prostheses in the lip support<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Soft tissue changes in µm with and without implant supported dental prostheses | Differences in the perioral soft tissues with and without dental prostheses in µm | Both scanning procedures will be made in the same appointment upon 3 months use of delivery of the final implant supported full dental prostheses | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Imaging, Three-Dimensional, Technology, Dental, accuracy, extra-oral scanner
Berlin Magnetic Seizure Therapy Depression Trial 01

Study Overview
=================
Brief Summary
-----------------
This treatment pilot study will investigate clinical efficacy and adverse effects of magnetic seizure therapy (MST) in patients currently experiencing a unipolar or bipolar depressive episode. The investigators will perform add-on tests to assess clinical and cognitive response to treatment. It is hypothesized that MST will have an antidepressant efficacy with a beneficial neurocognitive adverse effect profile.

Official Title
-----------------
Investigation of Efficacy and Tolerability of Magnetic Seizure Therapy in the Treatment of Depression

Conditions
-----------------
Unipolar Depression, Bipolar Depression

Intervention / Treatment
-----------------
* Procedure: magnetic seizure therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is diagnosed with a severe major depressive episode Patient is in a chronic current MDE and/or has had a history of recurrent MDEs Patient has not had an acceptable clinical response due to failure with at least 2 antidepressant treatments during the current episode Patient has a score > 20 on the HAMD24 Patient is stable on current psychotropic medication for at least 4 weeks Patient is > 25 and < 80 years Exclusion Criteria: Atypical Depression or psychotic depression (according to DSM IV) Other relevant psychiatric axis I or axis II diseases Relevant neurological diseases Relevant cardiac or pulmonary diseases with enhances anesthesiological risk (ASA Score > 3) Patient is currently enrolled in another investigational study not associated with the current study Patient has a history of, or evidence of, significant brain malformation or significant head injury

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MST<br> | Procedure: magnetic seizure therapy<br>* antidepressant treatment with MST<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Improvement (HAMD) |  | before, after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurocognitive performance |  | before/after treatment |