linjc16/ctgov huggingface dataset:
Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans

Study Overview
=================
Brief Summary
-----------------
Fifty MRI scans of patients with chronic lumbar back pain were graded radiologically using a wide range of classification and measurement systems. The reported effect of facet joint injections at the site was recorded and a comparative analysis performed.

Official Title
-----------------
Predictability of the Effects of Facet Joint Infiltration in the Degenerate Lumbar Spine When Assessing MRI Scans

Conditions
-----------------
Infiltration Facet Joint

Intervention / Treatment
-----------------
* Drug: infiltration with triamcinolone and bupivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients who had received inpatient gradual diagnostics for chronic lumbar back pain monosegmental facet joint infiltration on the first day of inpatient gradual diagnostics clearly stated pain relief in percentage (%) for that specific infiltration in the medical documentation pain level prior to infiltration needed to be clearly documented a high-quality MRI available before infiltration. Exclusion Criteria: ositive history of lumbar surgery or the presence of artificial implants in the area of interest
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: infiltration with triamcinolone and bupivacaine|facet joint infiltration|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of radiologic findings and reported pain relief | Pain relief is assessed as an improvement in % on the NRS. Radiologic findings consist of numerous classification systems and measurement techniques to evaluate and classify spinals and neural foramen stenosis, like for example as suggested by Schizas, or the sagittal diameter of the spinal canal | Improvement in pain level within 24 hours |
Bioequivalence of Two Mixtard® 30 Formulations in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Europe. The aim of this trial is to to test for bioequivalence between two formulations of Mixtard® 30 in healthy subjects.

Official Title
-----------------
A Randomised, Single Centre, Double-blind, Two-period Cross-over, Glucose Clamp Trial to Test for Bioequivalence Between Insulin Mixtard® 30 (600 Nmol/ml) and Insulin Mixtard® 30 (1998 Nmol/ml) in Healthy Subjects

Conditions
-----------------
Diabetes, Healthy

Intervention / Treatment
-----------------
* Drug: biphasic human insulin 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Considered generally healthy upon completion of medical history and physical examination as judged by the Investigator Body Mass Index (BMI) between 18.0 and 27.0 kg/m^2, inclusive Non-smoker, defined as no nicotine consumption for at least one year Fasting plasma glucose below or equal to 100 mg/dL (5.6 mmol/L) Exclusion Criteria: Previous participation in this trial or other clinical trials within the last 3 months Body weight above 87.5 kg Pregnant, breast-feeding or the intention of becoming pregnant or not using adequate contraceptive measures (intrauterine device (IUD) that has been in place for at least 3 History of alcohol or drug abuse

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Formulation A<br> | Drug: biphasic human insulin 30<br>* Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits<br>|
| Active Comparator: Formulation B<br> | Drug: biphasic human insulin 30<br>* Single dose of each formulation, administered subcutaneously (s.c., under the skin) on two separate dosing visits<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin concentration-time curve (AUC 0-24 hours) |  |  | 
| Maximum serum insulin concentration (Cmax) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the serum insulin concentration-time curve (AUC 0-6 hours) |  |  | 
| Area under the serum insulin concentration-time curve (AUC 6-24 hours) |  |  | 
| Area under the serum insulin concentration-time curve (AUC 0-inifinity hours) |  |  | 
| Time to maximum serum insulin concentration (tmax) |  |  | 
| Terminal insulin half life (t½) |  |  | 
| Adverse events |  |  |
WISE ARIC: Retinal Photography in Women With Chest Pain

Study Overview
=================
Brief Summary
-----------------
The purposes of this study are: To correlate the severity of retinal arteriolar narrowing and other microvascular changes, as determined from retinal photographs and video imaging, to measures of coronary microvascular function in women evaluated for chest pain. To evaluate measures of vascular compliance with applanation tonometry and photoplethysmography using a nasal alar probe.

Detailed Description
-----------------
Women who meet study eligibility criteria and provide written informed consent will have a baseline physical exam, including measurements of heart rate, blood pressure, weight. Medical history will be updated, specifically cardiovascular events (hospitalizations, procedures) since last contact and current medications. Patients will be scheduled for retinal photography. Those who are currently being screened and qualify for EWISE or other ancillary studies will have retinal photography scheduled as close to the index CFR as possible and prior to receiving randomized therapy. The retinal photography will follow a standardized written protocol. For the second protocol, 100 patients will be scheduled for an appointment in the Eye clinic where they will meet the Women's Ischemic Syndrome Evaluation (WISE)/Atherosclerosis Risk in Communities (ARIC) staff and complete the baseline information and have a brief physical examination. They will then have provocative testing completed with retinal imaging.

Official Title
-----------------
Retinal Photography in Women With Chest Pain: A WISE/ARIC Collaboration

Conditions
-----------------
Chest Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women who participated in or are being screened for the WISE or EWISE or any ancillary studies Willing to provide written informed consent Have recorded measurements of coronary flow reserve, with or without obstructive coronary disease Exclusion Criteria: Unwilling to complete study required procedures Contraindication to adenosine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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 |
| --- | --- | --- |
| Arteriole to venule ratio (AVR) | retinal arteriolar and venule diameters reflected as a ratio | baseline | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
women, chest pain, microvascular dysfunction, retinal photography, Retinal vascular function
Speech and Language Therapy After Stroke

Study Overview
=================
Brief Summary
-----------------
Our overall goal is to advance the state of functional brain imaging in aphasia, and then to apply the method to an intensive, imitation-based treatment for non-fluent aphasia.

Detailed Description
-----------------
Detailed information will follow in the next progress report.

Official Title
-----------------
Neurophysiological Measurement in Aphasia Treatment

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

Intervention / Treatment
-----------------
* Behavioral: Imitate Therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Single ischemic infarction in the MCA territory involving the cerebral cortex (confirmed by CT or MRI) Aphasia Visual attention and language comprehension sufficient to perform imitation fMRI tasks Right handed (prior to stroke) Exclusion Criteria: Exclusions to the study are people with cardiac pacemakers, claustrophobia, neurosurgical clips, or cognitive impairments too severe to permit cooperation with cognitive tasks in an MRI scanner.
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br>Computer-based Aphasia therapy | Behavioral: Imitate Therapy<br>* Imitation-based computer therapy<br>* Other names: Imitate;|
| Active Comparator: Control<br>Control Arm - Healthy subjects. | Behavioral: Imitate Therapy<br>* Imitation-based computer therapy<br>* Other names: Imitate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in scores on Western Aphasia Battery |  | Four months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, aphasia, imitation, mirror neuron
Almond for Physical Performance

Study Overview
=================
Brief Summary
-----------------
Investigators specific aims are to compare the effects of consuming daily snacks of raw, shelled, unsalted almonds (2.0 ounces) versus an isocaloric amount of another commonly consumed snack food (pretzels) on energy (vigor) perception and physical activity, exercise performance (VO2max and measures of strength), strength and power performance as well as muscle soreness recovery after strenuous eccentrically-biased exercise.

Detailed Description
-----------------
To accomplish these aims, investigators will examine whether regular consumption of almonds versus a common snack food over a period of 8 weeks impacts longer term metabolic, physiological and behavioral responses related to energy sensations and exercise capacity/performance.

Official Title
-----------------
Roles of Almonds in Physical Performance

Conditions
-----------------
Energy, Muscle Soreness

Intervention / Treatment
-----------------
* Other: Almond
* Other: Control group


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 30-50 years old BMI of 23-30 Exclusion Criteria: smoking, medications known to impact inflammation, musculoskeletal limitations and use of supplements within 1 month of participation that are known to impact antioxidant use of supplements within 1 month of participation that are known to impact inflammatory status

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 50 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Almond<br>Participants will consume 2.0 oz of raw, shelled, unsalted almonds. | Other: Almond<br>* 2.0 oz of raw, shelled, unsalted almonds<br>|
| Active Comparator: Control group<br>an isocaloric (2.0 oz raw almonds) amount of unsalted pretzels daily. | Other: Control group<br>* an isocaloric amount of unsalted pretzels<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in energy (vigor) perception | Energy (vigor) perception will be assessed using POMS questionnaire | At baseline , at 8 weeks | 
| Changes from baseline in exercise performance | VO2max will be assessed for measuring exercise performance | At baseline , at 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in strength and power performance | strength and power performance by be measure by biodex | At baseline, at 8 weeks | 
| Changes from baseline in muscle soreness | muscle soreness will be measured by DOMES questionnaire | At baseline, at 8 weeks |
Observational Study Describing Conditions for Intensification of Insulin Therapy in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to determine diabetes control improvement, during the third month of follow-up after insulin intensification to at least 3 daily insulin injections, in assessing the proportion of uncontrolled fasting and postprandial glycaemia values recorded on a diary.

Official Title
-----------------
Observational Study on Efficacy of Intensification of Insulin Therapy to at Least 3 Daily Injections in Type 2 Diabetes

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes patients Treatment with two insulin daily injections and needing insulin intensification regimen to at least three daily injections HbA1c greater than or equal to 8.0% Exclusion Criteria: Patients not performing glycaemia self-measurements Secondary diabetes Requirement of or use of an insulin pump Treatment with corticoids

Ages Eligible for Study
-----------------
Minimum Age: 40 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 |
| --- | --- |
| A<br> | Drug: insulin<br>* Start dose and frequency to be prescribed by the physician as a result of the normal clinical evaluation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements |  | After 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate improvement of diabetes control with fasting glycemia and after diner glycemia measurements |  | After first 2 months |
Safety and Efficacy of Insulin Aspart in Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Japan. The aim of this trial is to investigate the safety and efficacy of NovoRapid® (insulin aspart) as meal time insulin in subjects with type 2 diabetes treated on a basal-bolus regimen with Neutral Protamine Hagedorn (NPH) human insulin.

Official Title
-----------------
An Open-labelled, Single-arm, Multi-centre, 6-month Study to Investigate the Safety and Efficacy of NovoRapid as Meal Time Insulin in Type 2 Diabetes Patients Treated on a Basal-bolus Regimen With NPH Human Insulin

Conditions
-----------------
Diabetes, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: insulin aspart


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Treated with insulin for at least 12 months and currently on a basal-bolus regimen for at least 12 weeks HbA1c below or equal to 11.0% BMI (body mass index) below 30 kg/m^2

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Insulin aspart<br> | Drug: insulin aspart<br>* Administrated subcutaneously (s.c., under the skin) three times a day before each meal for 24 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of hypoglycaemia |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events (AEs) |  |  | 
| Clinical laboratory tests: Haematology and biochemistry |  |  | 
| Insulin antibodies |  |  | 
| Glycaemic control parameters: Glycosylated haemoglobin A1c (HbA1c), fasting plasma glucose (FPG) and post-prandial plasma glucose (PPPG) |  |  |
The Effects of Spinal Mobilizations on Symptoms, Neck 3D Movement, Neck Muscle Electromyography and Sympathetic Nervous System Activity in People With Neck Pain

Study Overview
=================
Brief Summary
-----------------
This study investigates the effects of spinal mobilizations on symptoms, 3D movement of the neck, neck muscle electromyography and sympathetic nervous system activity in people with neck pain.

Conditions
-----------------
Neck Pain

Intervention / Treatment
-----------------
* Other: Neck passive mobilizations
* Other: Manual contact


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intermittent neck pain That worsens or improves with certain neck movements or positions Has not been caused by a blow, fall or accident Exclusion Criteria: Cervicobrachialgia Has been treated with or is awaiting neck surgery Diagnosed with a particular inflammatory disease or spinal condition Where treatment with cervical mobilizations is contraindicated

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Neck passive mobilizations<br>Neck passive mobilizations | Other: Neck passive mobilizations<br>* Passive mobilizations performed to the neck of the participant by a Physiotherapist<br>|
| Placebo Comparator: Manual contact<br>Manual contact | Other: Manual contact<br>* Manual contact applied to the neck of the participant by a Physiotherapist<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in muscle activity assessed by neck muscle electromyography |  | Baseline and 2 minutes after intervention | 
| Change in 3D neck movement assessed with a 10 camera Vicon system |  | Baseline and 2 minutes after intervention | 
| Change in sympathetic nervous system activity assessed by measuring right hand finger temperature | Measurement unit: degrees celsius | Baseline for 2 minutes immediately before intervention, during intervention (15 minutes) and for 2 minutes immediately after intervention | 
| Change in sympathetic nervous system activity assessed by measuring right hand finger galvanic response | Measurement unit: microsiemens | Baseline for 2 minutes immediately before intervention, during intervention (15 minutes) and for 2 minutes immediately after intervention | 
| Global rating of change scale |  | Baseline and 10 minutes after intervention |
Effectiveness of Global Postural Reeducation in Patients With Chronic Symptomatic Lumbar Disc Herniation

Study Overview
=================
Brief Summary
-----------------
Slipped disc is the rupture of the fibrous ring, with subsequent displacement of the nucleus pulposus in intervertebral spaces, which may cause compression of nerve structures. It is estimated that 2-3% of the population have taken with this process, whose prevalence is 4.8% in men and 2.5% in women over 35 years. Thus, the purpose of this study is to verify the effectiveness of global postural reeducation in patients diagnosed with chronic symptomatic lumbar disc herniation with the application of a randomized controlled trial. Will be measured pain, disability and functional flexibility.

Official Title
-----------------
Effectiveness of Global Postural Reeducation in Patients With Chronic Symptomatic Lumbar Disc Herniation

Conditions
-----------------
Lumbar Disc Herniation.

Intervention / Treatment
-----------------
* Other: Global postural reeducation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed with chronic symptomatic lumbar disc herniation Exclusion Criteria: Patients who work with severe overloading of the spine, patients with central neurological pathology, wheelchair users, patients who use bracing and support those who submit two consecutive absences to the treatment

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Lifestyle counseling<br> | Other: Global postural reeducation<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |