linjc16/ctgov huggingface dataset:
The Use of Real Time Ultrasound Feedback in Teaching Abdominal Hollowing Exercises

Study Overview
=================
Brief Summary
-----------------
Recently, physical therapists have begun treating people who have mechanical low back pain, hypothesized to be caused by segmental instability in the lumbar spine, with a very specific exercise program consisting of trunk stabilization exercises. The theory behind the use of trunk stabilization exercises to treat lower back pain is that active contraction of the trunk local segmental muscles helps to control inter-segmental movement in the spine. The initial trunk stabilization exercise that physical therapists teach patients is an abdominal drawing in maneuver often called an abdominal hollowing exercise (AHE). A challenge for physical therapists is to establish the most effective means of teaching people to contract the relevant muscles needed to perform the AHE. The purpose of this study is to examine if supplementing the typical clinical instruction for teaching the AHE with visual ultrasound feedback to the patient is effective at reducing the length of time it takes an individual to learn to perform an AHE. Three groups of research volunteers will be taught how to do the AHE while receiving different kinds of feedback about their performance in order to determine which type of feedback is most effective in assisting people to learn the AHE. Group 1 will not receive any feedback about performance; Group 2 will receive feedback from palpation and verbal descriptive alone; and Group 3 will receive feedback from palpation, verbal descriptive feedback, and real time ultrasound. For the initial test when subjects are learning the AHE, the number of trials until the subject demonstrates his/her third correct AHE will be the outcome variable. For the retention test, the outcome variable will be the percentage of trials (out of ten) of correctly performed AHEs in the absence of visual, verbal or palpation feedback.

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Device: Visual utrasound feedback
* Procedure: Abdominal Hollowing Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy volunteers

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Visual utrasound feedback|nan|
|Procedure: Abdominal Hollowing Exercise|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
-----------------
Abdominal Hollowing Exercises
Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)

Study Overview
=================
Brief Summary
-----------------
Ankylosing spondylitis (AS) is a rheumatoid disease affecting all segments of the axial skeleton, leading to the complete fusion of all spinal segments - the bamboo-spine. During the last decade biological disease modifying anti-rheumatic drugs (bDMARD) have been successfully introduced to reduce the disease activity. It is unclear whether bDMARD treatment had an effect on spinal fracture risk related to AS. This national registry study will investigate the effect of bDMARD treatment on spinal fracture risk in a national cohort of patients with AS.

Official Title
-----------------
Effect of Biological Disease Modifying Anti Rheumatic Drug (bDMARD) Treatment on Spinal Fracture Incidence in Patients With Ankylosing Spondylitis (AS)

Conditions
-----------------
Ankylosing Spondylitis, Spinal Fractures

Intervention / Treatment
-----------------
* Drug: bDMARD treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age 30-60 years registered diagnosis of ankylosing spondylitis Exclusion Criteria: age <30 or >60 years

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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 |
| --- | --- |
| AS patients<br>Patients registered in the Swedish Patient Registry with active AS treated with or without biological DMARD according to the Swedish Prescribed Drugs Registry, with or without spinal fractures | Drug: bDMARD treatment<br>* Treatment with bDMARD includes registered ATC-codes: L04AA and L04AB.<br>* Other names: Biological Disease Modifying Drug treatment;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Spinal fracture | Censored data with occurrence of spinal fracture within 10 years observation | 10 years |
Supervised Outdoor-Use Test For Sunscreen Products in Adults

Study Overview
=================
Brief Summary
-----------------
To assess the safety of a sunscreen product under supervised outdoor-use conditions

Official Title
-----------------
Supervised Outdoor-Use Test For Sunscreen Products in Adults

Conditions
-----------------
Sunscreening Agents

Intervention / Treatment
-----------------
* Drug: BAY987517
* Drug: Sunscreen Lotion (Y65-110)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be healthy, males or females between 18 to 65 years of age with no medical conditions of the skin. Subjects must have Fitzpatrick Skin Type I, II, III or IV. Subjects must agree to restrict their sun exposure activities for at least five days immediately preceding participation in the study. Exclusion Criteria: Subjects must not have actinic keratoses, skin cancer, psoriasis, eczema, or any other acute or chronic skin conditions. Subjects must not have visible erythema, blistering, or peeling that would indicate recent sunburn as determined by the baseline skin evaluation. Subjects must not have significantly tanned skin.

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Arm 1<br>2/3 of subjects testing the test article | Drug: BAY987517<br>* Applied liberally to the skin (Formulation: Y73-161<br>|
| Active Comparator: Arm 2<br>1/3 of subjects testing the marketed control | Drug: Sunscreen Lotion (Y65-110)<br>* Applied liberally to the skin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Skin response to sun exposure according to the Skin Evaluation Response Scale from 0 to 3 |  | From the beginning of the study until 24 hours after study |
Evolution of the Profile of Infectious Endocarditis in France in 2008 (EI2008)

Study Overview
=================
Brief Summary
-----------------
Infective endocarditis (IE) is a rare (30 cases / million / year in France) and serious (20 % of deaths during hospitalization) disease . Its epidemiological profile was considerably modified these last years.New predisposing factors appeared, due to increasing number of patients wearing valvular prosthetics. The purpose of this study is to realize in 2008 a new observational study on populational basis to describe and analyze the evolution of the epidemiology of IE in France, compared to previous studies conducted in 1991 and 1999.

Detailed Description
-----------------
It is a prospective observational study based on a population of 25 million inhabitants. The cases are recruited over a one year period, from January 1st till December 31st, 2008, in six regions of France (Rhône-Alpes, Paris et Petite Couronne, Lorraine, Franche-Comté, Marne, Languedoc-Roussillon) and in the department of Ille-et-Vilaine. The IE cases are declared by clinicians taking care of the patients, microbiologists and cardiac ultrasonographists.

Official Title
-----------------
Evolution of the Profile of Infectious Endocarditis in France in 2008

Conditions
-----------------
Infective Endocarditis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Major Patient Supported in one of the participating centers The application of diagnostic classification criteria of Duke modified by Li is carried out after collection of all the data at the output of the patient. Will be included in the observatory that patients meeting criteria for definite or possible endocarditis. Affiliated with the French social security regime Exclusion Criteria: Patients not living in one of the studied regions

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 |
| --- | --- | --- |
| Mortality | Vital status | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of antibiotic resistance by the germs (streptococci and staphylococci) | antibiotic treatments and outcome | during the hospitalization, 1 year maximum |
Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation

Study Overview
=================
Brief Summary
-----------------
This research project will compare the use of the double wire technique with the placement of a pancreatic duct (PD) stent to achieve deep biliary cannulation without the use of a precut papillotomy. Currently, the data supporting either of these approaches is limited to the referenced case series. More data on the success and complication rates of these techniques are needed. The investigators believe either of these approaches would be preferred by less experienced endoscopists to precut papillotomy. Consequently, it is important to differentiate these techniques and identify which patients may benefit from one or both.

Official Title
-----------------
Comparison of Double Wire Technique With Pancreatic Duct Stent Placement for Difficult Bile Duct Cannulation: a Randomized Clinical Trial

Conditions
-----------------
Endoscopic Retrograde Cholangiopancreatography (ERCP), Bile Duct Cannulation

Intervention / Treatment
-----------------
* Procedure: Pancreatic duct stent
* Procedure: Pancreatic wire placement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: First time ERCP Exclusion Criteria: Successful bile duct cannulation within six minutes Planned pancreatic duct therapy Planned pancreatobiliary manometry Prior successful ERCP

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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Pancreatic duct stent<br>Placement of a pancreatic duct stent to facilitate bile duct cannulation | Procedure: Pancreatic duct stent<br>* Placement of a pancreatic duct stent to facilitate bile duct cannulation<br>|
| Active Comparator: Pancreatic wire<br>Placement of a guidewire into the pancreatic duct to facilitate bile duct cannulation. | Procedure: Pancreatic wire placement<br>* Placement of a pancreatic wire to facilitate bile duct cannulation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cannulation success rate |  | Cannulation is assessed during the index procedure; procedure-related complications are assessed within one week of the procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complication rate |  | One week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients undergoing endoscopic retrograde cholangiopancreatography for the first time, Particular focus on patients who meet predefined criteria for a difficult bile duct cannulation
Pharmacokinetic Study of Fluconazole in Premature Infants

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the pharmacokinetics of fluconazole which is used as prophylaxis of invasive fungal infection in premature infants.

Conditions
-----------------
Very Low Birth Weight Infant

Intervention / Treatment
-----------------
* Drug: Fluconazole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: very low birth weight infant (birth weight < 1,500 g) who were admitted to the NICU before day 3 of life Informed consent from the parents Exclusion Criteria: Major congenital anomaly Expired within 72 hours of life Liver failure (AST or ALT levels with three times the upper limit of the range of normal values or higher) Proven congenital or intrauterine fungal infection

Ages Eligible for Study
-----------------
Maximum Age: 4 Weeks

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Population PK<br> | Drug: Fluconazole<br>* Prophylactic fluconazole administration in VLBW infants<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drug level of fluconazole | four times drug level after 3th dose | 30min later, 10-12hr later, at routine lab with interval of 1week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fluconazole
A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to make a cohort event monitoring to see whether and how Shuxuetong injection in hospital results in adverse events or adverse drug reactions.

Detailed Description
-----------------
This is the first academic registry study about adverse events or adverse drug reaction for Chinese medicine injection in mainland China. It is well known that Chinese medicine injection is just limited in mainland China, which also be accepted by China health care system. However, more and more adverse events or adverse drug reaction have been reported in recent years in the form of case report. In order to improving monitoring adverse events or adverse drug reaction of Chinese medicine injection in hospital, registry study will be introduced in this area. To calculate the incidence of adverse events or adverse drug reaction is one of the main aims for this study. According to the 'rule of three', 30,000 cases need to be registered at least.

Official Title
-----------------
A Registry Study on Shuxuetong (a Chinese Medicine Injection) Used in Twenty Hospitals

Conditions
-----------------
Ischemic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all inpatients use Shuxuetong injection in 20 selected hospitals during their hospital stay
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Shuxuetong injection<br>a cohort using Shuxuetong injection | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with adverse events; incidence of Shuxuetong'ADRs and identify factors that contributed to the occurrence of the adverse reaction | All participants will be followed for the duration of hospital stay, an expected average of 2 weeks.Patients using Shuxuetong will be registered on a registration form including disease background, Shuxuetong's administration, and extraction information from hospital information system. An adverse event or drug adverse reaction form also will be used to describe any doubted symptoms or signs from patients. A judgment will be made by doctors directly and a further analysis will be conducted by researchers to decide those potential side effects of Shuxuetong. | to assess Shuxuetong's adverse event and drug adverse reaction during patients' hospital stay, administration information of Shuxuetong will be registered every day. The registry procedure will last 3 years only for patients using Shuxuetong. |
A Study to Assess the Effect of ASP1585 on Pharmacokinetics of Valsartan in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
This study is to assess the effect of ASP1585 on pharmacokinetics of valsartan in 2x2 crossover method

Official Title
-----------------
ASP1585 Pharmacokinetic Interaction Study - Pharmacokinetic Interaction With Valsartan -

Conditions
-----------------
Healthy, Pharmacokinetics of Valsartan

Intervention / Treatment
-----------------
* Drug: ASP1585
* Drug: valsartan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body weight: =<50.0kg, <80.0kg Body mass index: =<17.6, <26.4 Healthy as judged by investigator or caregiver from subjective and objective symptoms and physical examination data Exclusion Criteria: Attending another clinical trial within 120 days before the study Blood donation within 90 days (400ml) or 30 days (200ml) before the study Receiving any drugs within 7 days before the study History of allergy to drugs Having GI disorders History or complication of liver diseases History or complication of heart disease History or complication of respiratory diseases History or complication of renal diseases History or complication of cerebrovascular diseases

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 44 Years

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

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

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

Design Details

Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: single-add first group<br>single administration first, then concomitant administration | Drug: ASP1585<br>* oral<br>Drug: valsartan<br>* oral<br>* Other names: Diovan;|
| Experimental: combi-add first group<br>concomitant administration first, then single administration | Drug: ASP1585<br>* oral<br>Drug: valsartan<br>* oral<br>* Other names: Diovan;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentration of valsartan |  | for 48 hours after administration | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety assessed by AE, vital signs 12-lead ECG and lab tests |  | for 5 days after administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASP1585, Drug-drug interaction, valsartan, Healthy volunteer
Patellar Tendinopathy - Effect of Training and Enhancement of the Collagen Synthesis by Insulin-like Growth Factor-I

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to test the hypothesis that stimulation of the synthesis of new structural tendon proteins combined with training improve the tendon structure in patients with chronic knee tendon pain.

Detailed Description
-----------------
Randomized controlled intervention study: 12 weeks intervention period with training and injections of saline or Insulin-Like growth factor I. One year follow-up

Official Title
-----------------
Effect of Training and Local Infusion of Insulin-like Growth Factor-I and Training on Tendon Structure in Patients With Patellar Tendinopathy

Conditions
-----------------
Tendinopathy

Intervention / Treatment
-----------------
* Drug: Insulin-like growth factor I
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic patellar tendinopathy (> 3 months) anterior-posterior thickening of the tendon (1 mm compared to mid-tendon) hypo-echoic area with enhanced vascularization Exclusion Criteria: injection corticosteroid injection within the last 12 months Knee operation Knee osteoarthritis Diabetes Smoking Body mass index >30

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Insulin-like growth factor I<br>3 injection (1 mg), once a week the first 3 weeks of the 12 weeks of intervention | Drug: Insulin-like growth factor I<br> <br> |
| Placebo Comparator: Placebo injections<br>3 Injections of saline into the patellar tendon 3 times during the first 3 weeks of the 12 weeks interventions period | Drug: Placebo<br> <br> * Other names: Saline Injections;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon structure |  | After 12 weeks intervention (tendon biopsy) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tendon Pain | questionnaire | 1 year (before and after 12 weeks intervention and 1 year after intervention start) |