linjc16/ctgov huggingface dataset:
Neural Mechanisms in Asthma

Study Overview
=================
Brief Summary
-----------------
Asthma is a chronic disease that affects nearly 13% of adults in the U.S., causing substantial impairment that is reflected in the tens of millions of missed days of work, and doctors' and emergency room visits it leads to annually. Those who have asthma are twice as likely to develop depression and anxiety, which are associated with more frequent and severe asthma symptoms, especially in those under chronic stress. The project proposed here seeks to understand the role of the brain in these associations and to evaluate the neural mechanisms through which a safe, low-cost intervention, that influences the function of body via the mind, may diminish the expression of asthma symptoms.

Official Title
-----------------
Neural Mechanisms by Which Chronic Stress Regulates Inflammation in Asthma

Conditions
-----------------
Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthmatics: Physician diagnosed asthma with previous use of asthma medication Controls: negative skin-prick test to cat dander or house dust mite and have no history of asthma Chronic Stress: score 3 or above on any subscale of the UCLA (University of California Los Angeles) chronic stress interview No chronic stress: score 1.5 or below on all subscales of the UCLA chronic stress interview Exclusion Criteria: Individuals with severe asthma, or those whom currently require the use of corticosteroids Individuals with significant medical problems Individuals who smoke cigarettes Individuals a previous adverse reaction to corticosteroids, a recent (< 1 month) viral illness, a history of severe asthma or anaphylaxis. Breastfeeding women or women who are, suspect they might be or are trying to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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 |
| --- | --- |
| Asthmatic, chronic stress<br> | |
| Asthmatic, non-stress<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neural activity in response to stress | positron emission tomography | duration of stress (30 minutes) | 
| inflammation | infiltration of eosinophils into lung sputum, percentage of blood eosinophils, exhaled nitric oxide, glucocorticoid sensitivity of peripheral blood leukocytes | 24 hours | 
| lung function | peak expiratory volume in 1 sec effort | 24 hours | 
| peripheral acute stress reactivity | salivary cortisol and alpha amylase in response to acute stressor | 60 minutes |
Surgical Plate Osteosynthesis of Distal Radius Fractures

Study Overview
=================
Brief Summary
-----------------
Primary objective of the study is to demonstrate specific indications for the surgical treatment of distal radius fractures using the locking compression plate.

Detailed Description
-----------------
In addition the differences between the surgical treatment compared to conservative treatment with respect to fracture healing, functional outcome and subject satisfaction will be analysed after 6w./6m./1y./2y.

Official Title
-----------------
Surgical Plate Osteosynthesis of Distal Radius Fractures. Prospective Study of the Locking Compression Plate (LCP)

Conditions
-----------------
Distal Radius Fractures

Intervention / Treatment
-----------------
* Device: Locking Compression Plate 2,4mm
* Device: Locking Compression Plate 3,5mm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: skeletally mature female and male Distal radius and ulnar fractures AO 23 10 days after injury Exclusion Criteria: general or local conditions adversely affecting the bone physiology ISS >16 osteosynthesis close to the wrist joint where a different implant has been used history of drug and alcohol abuse

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Locking Compression Plate 2,4mm|nan|
|Device: Locking Compression Plate 3,5mm|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Document specific indications for the surgical treatment of distal radius fractures using the LCP |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| - Primary reduction and maintenance of reduction of the plate fixation |  |  | 
| - Functional outcome scoring using Garetland and Werley, DASH and SF-36 scoring |  |  | 
| - Patient and surgeon satisfaction |  |  | 
| - Analysis of the occured complications |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Locking Compression Plate, Conservative treatment, Surgical treatment, Radius fractures, AO 23
Comparison Between Perineural and Systemic Effect of Dexamethasone for Interscalene Brachial Plexus Block.

Study Overview
=================
Brief Summary
-----------------
The addition of dexamethasone (DxaM) to local anesthetic may significantly prolong the duration of a block. The aim of this study is to determine whether this a systemic or local effect.

Official Title
-----------------
Comparison Between Perineural and Systemic Effect of Dexamethasone as an Adjuvant for Prolongation of the Interscalene Brachial Plexus Block.

Conditions
-----------------
Analgesia

Intervention / Treatment
-----------------
* Drug: Dexamethasone
* Drug: Bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pre-surgical patients for arthroscopic or open shoulder surgery Exclusion Criteria: Skin infection near block site Allergy to local anesthetics Peripheral neuropathy Proven opioid dependency Coagulopathy Dementia

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group I (ISB-P)<br>Interscalene block with perineural injection of dexamethasone 0.1 mg/kg | Drug: Dexamethasone<br> <br> Drug: Bupivacaine<br> <br> |
| Active Comparator: Group II (ISB-S)<br>Interscalene block with systemically injection of dexamethasone 0.1 mg/kg. | Drug: Dexamethasone<br> <br> Drug: Bupivacaine<br> <br> |
| Active Comparator: Group III - ISB-C<br>Interscalene block without adjuvant. | Drug: Bupivacaine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy DxaM Perineural | Duration of motor and sensory block. | One day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy of Systemic DxaM | Duration of motor and sensory block | One day |
Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh

Study Overview
=================
Brief Summary
-----------------
Vaginal prolapse is a common condition that is treated with surgical correction. Recently surgeons have been using mesh to augment the repair of vaginal prolapse. Common complications of this surgery include vaginal pain, pain during sex, infection or erosion of the mesh in the vagina. There are different ways to close the vaginal wall over the mesh used in these procedures. Currently, there is no accepted standard method of closing the vaginal wall. The purpose of this study is to find out the best way to close the surgical wound in the vagina. We will compare interrupted closure (separate stitches) to continuous closure (one long, running stitch). We hope to show in our study that one method of closure is better than the other.

Official Title
-----------------
Randomized Trial of Interrupted Versus Continuous Vaginal Closure of Anterior Repair With Mesh

Conditions
-----------------
Pain, Dyspareunia, Surgical Mesh

Intervention / Treatment
-----------------
* Procedure: Interrupted vaginal closure
* Procedure: Continuous vaginal closure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for surgery to correct anterior vaginal prolapse with mesh kit Exclusion Criteria: Pregnant

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

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

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

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: 1<br>Interrupted vaginal closure | Procedure: Interrupted vaginal closure<br>* Horizontal mattress closure of vaginal mucosa over mesh<br>|
| Active Comparator: 2<br>Continuous vaginal closure | Procedure: Continuous vaginal closure<br>* Running closure of vaginal mucosa over mesh<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mesh exposure |  | One year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain |  | One year | 
| Dyspareunia |  | One year |
Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function

Study Overview
=================
Brief Summary
-----------------
To evaluate the influence of superior versus temporal laser peripheral iridotomy location on post-operative visual acuity and contrast sensitivity.

Official Title
-----------------
Effect of Peripheral Laser Iridotomy Placement on Post-operative Visual Function

Conditions
-----------------
Glaucoma, Angle-Closure

Intervention / Treatment
-----------------
* Procedure: Superior laser peripheral iridotomy
* Procedure: Temporal laser peripheral iridotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Angle-closure glaucoma Angle-closure glaucoma suspect Exclusion Criteria: Monocular status Previous intraocular surgery Visual acuity worse than 20/40 Prior episode of acute angle-closure glaucoma Pregnancy

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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Paired eye
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Bilateral iridotomy: Superior<br>Each subject in this single-arm study undergoes bilateral laser peripheral iridotomy surgery. Each participant will undergo superior laser peripheral iridotomy in one eye and temporal laser peripheral iridotomy in the fellow eye. | Procedure: Superior laser peripheral iridotomy<br>* Iridotomy placement between 11:00 and 1:00 o'clock<br>|
| Experimental: Bilateral iridotomy: Temporal<br>Each subject in this single-arm study undergoes bilateral laser peripheral iridotomy surgery. Each participant will undergo superior laser peripheral iridotomy in one eye and temporal laser peripheral iridotomy in the fellow eye. | Procedure: Temporal laser peripheral iridotomy<br>* Iridotomy placement at 3:00 or 9:00 o'clock<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in visual acuity | Change from baseline best corrected visual acuity evaluated in number of letters correctly read on the ETDRS chart | 30 days post-operative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Peli-Robson contrast sensitivity | Change from baseline in contrast sensitivity evaluated in number of letters correctly read on the Peli-Robson chart | 30 days post-operative | 
| Change in CSV-1000 contrast sensitivity | Change from baseline in contrast sensitivity evaluated using the number of correct responses on the CSV-1000 test | 30 days post-operative |
Myopia Progression and the Effect of 7-Methylxanthine

Study Overview
=================
Brief Summary
-----------------
7-methylxanthine has been shown to increase the concentration and thickness of collagen fibrils in rabbit sclera. Deficient collagen in the sclera may be the cause of progression of childhood myopia. The study hypothesis is that treatment with 7-methylxanthine will stabilize the sclera and prevent further progression of myopia.

Detailed Description
-----------------
Participants are given tablets of 7-methylxanthine 400 mg per day or placebo tablets for 12 months. Axial length, cycloplegic refraction and corneal curvature is measured, as well as weight, height, blood pressure and heart rate. The participants are interviewed about possible CNS, gastrointestinal, or cardiopulmonal side effects.

Official Title
-----------------
Phase 2 Study of the Effect of 7-Methylxanthine on the Progression of Childhood Myopia

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Drug: 7-methylxanthine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children in the age 8-13 years with myopia and an axial growth rate of 0.15 mm or more per year. - Exclusion Criteria: Severe general ailment (for example diabetes, epilepsy, psychiatric disease) Eye diseases (for example cataract, keratoconus, chronic iritis, glaucoma) -

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 13 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: 7-methylxanthine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Axial growth |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Myopia progression |  |  |
TYGRIS - ROW: TYSABRI Global Observational Program in Safety - Rest of World

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine the incidence and pattern of serious infections, malignancies, and other serious adverse events (SAEs) in participants with multiple sclerosis (MS) treated with TYSABRI (natalizumab).

Detailed Description
-----------------
The TYSABRI Global Observational Program in Safety for Rest of World (TYGRIS - ROW)is a safety observational cohort program designed to obtain long-term safety data in multiple sclerosis (MS) participants treated with TYSABRI in a clinical practice setting in countries other than the United States and Canada. The Prescribing Physician will collect participant information at routine clinic visits (using standard data collection tools) at approximately 6-month intervals for 5 years from the first TYSABRI infusion.

Official Title
-----------------
TYGRIS - ROW: TYSABRI® Global Observational Program in Safety - Rest of World

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: All Multiple Sclerosis (MS) participants in Rest of World (ROW) who are prescribed and receiving TYSABRI in normal clinical practice at centers that are taking part in the study are eligible to participate in TYGRIS - ROW. Participants must have received at least 1 and not more than 3 infusions of TYSABRI. NOTE: Other protocol defined Inclusion/Exclusion criteria may apply.
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 |
| --- | --- | --- |
| Number of participants with serious infections, malignancies, and other serious adverse events (SAEs) |  | 5 Years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
TYGRIS - Rest of World (ROW), TYSABRI, natalizumab, Multiple Sclerosis
Hypertensive Treatment Pattern Survey for Type II Diabetes Mellitus Patients With Complication and Hypertension

Study Overview
=================
Brief Summary
-----------------
This study will address the treatment rate and control rate of hypertension, treatment pattern and factors to affect blood pressure control by examining (retrospective) medical records of Type II DM patients with DM related complication and hypertension, among outpatients coming to the Endocrinology Department in 20 general hospital settings nationwide.

Official Title
-----------------
A Retrospective, Multi Centre, Non-interventional, Observational Study to Investigate Treatment Pattern of Blood Pressure in the Type II Diabetes Mellitus Patients With DM Related Complication and Hypertension.

Conditions
-----------------
Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: After diagnosed type II DM, patients received treatment for a least 3 years Type II DM patients with hypertension and its complication. Visited out-patients to care center after 1 Jan. 2008 Exclusion Criteria: Secondary hypertension patients Patients not receiving hypertension medication Patients stopping BP medication, by physician's order Patients currently enrolled in other clinical studies

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>Type II Diabetes Mellitus patients with Complication and Hypertension | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attainment rate to the target blood pressure. |  | After collecting all Patient Record Form. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Attainment to the target blood pressure will be investigated according to DM related complications. |  | After collecting all Patient Record Form. | 
| Change in the DBP/SBP value will be investigated according to the DM Complication |  | After collecting all Patient Record Form. | 
| Treatment pattern and factors that affect BP control |  | After collecting all Patient Record Form. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hypertension, Type II DM, DM related complication, JNC7, 2007 ESH-ESC guidelines, survey
Bone Scintigraphy and Unicompartimental Knee Arthroplasty

Study Overview
=================
Brief Summary
-----------------
Study the potential interest of bone scintigraphy for patients undergoing unicompartmental knee arthroplasty

Detailed Description
-----------------
Knee osteoarthritis is a very common disease with significant functional consequences. Surgical treatment is the ultimate treatment with the possibility of replacing only one compartment or the 3 joint compartments. Consequently, the pre-surgical imaging is essential to ensure that the 3 compartments are not compromised when a uni-compartmental prosthesis (PUC) is considered. The scintigraphy because of its good diagnostic performance seems to be interesting in this indication for the preoperative assessment of knee uni-compartmental prostheses to ensure the absence of degenerative lesion of the unoperated compartment. This study will evaluate the impact of bone scintigraphy on surgery and the potential correlation between scintigraphic and clinical data; study the pronostic impact of bone scintigraphy

Official Title
-----------------
Interest of Bone Scintigraphy in Pre-operative Assessment of Knee Osteoarthritis in Patients Undergoing Unicompartmental Knee Arthroplasty

Conditions
-----------------
Bone Scintigraphy and Knee Arthroplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient over 18 years old / uni or bilateral unicompartmental knee prothesis/ non opposition Exclusion Criteria: Under 18 years old/ contraindications for bone scintigraphy/ refusal to participate

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| modification in surgical strategy according to bone scintigraphy results | pourcentage of therapeutic modification according to bone scintigraphy results | 18 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bone scintigraphy, knee arthroplasty, spect-ct, quantification