linjc16/ctgov huggingface dataset:
Visibility - Classification of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks

Study Overview
=================
Brief Summary
-----------------
We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves.

Detailed Description
-----------------
We assessed the visibility of peripheral nerves while ultrasound guided blockades with a novel scoring system to evaluate differences in visibility of different nerves. VIS(visibility) 1 easy identification and instant visualisation of all structures VIS 2 identification and visualisation of all structures after some corrections VIS 3 identification and visualisation of structures only unsure VIS 4 identification and visualisation of all structures impossible VIS 5 no structures seen. We amended a sub-project in which assessed the visibility in protective nerve stimulated nerve blocks in 46 patients.

Official Title
-----------------
Visibility - A Novel Classification Score of Sono-visibility of Anatomical Structures in Peripheral Nerve Blocks

Conditions
-----------------
Anesthesia, Local, Anesthesia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria (study sample N=1200): peripheral nerve block by ultrasound guidance age ≥ 18 years Exclusion Criteria: contraindications for regional anesthesia Inclusion Criteria (study sample as of amendment n=46): peripheral nerve block by ultrasound guidance age ≥ 18 years Exclusion Criteria: contraindications for regional anesthesia (study sample n=46) using not the standard ultrasound machine performing not a standard regional anesthesia

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 |
| --- | --- |
| Patients receiving Regional Anesthesia<br>All patients 18 years or older with a peripheral nerve block at Charité - Universitätsmedizin Berlin Campus Charite Mitte from 2012 to 2016. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visibility | The ultrasound visibility of the nerve scored by a 5-step scale. | During regional block (an average of 1 hour) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Additional analgesia | The need and amount of additional analgetic drugs while the intervention. | During surgery (an average of 4 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nerve block, peripheral nerve stimulation
Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of CeD Symptoms

Study Overview
=================
Brief Summary
-----------------
To assess the efficacy and safety of larazotide acetate versus placebo for the relief of persistent symptoms in adult celiac disease patients.

Detailed Description
-----------------
This is a phase 3, randomized, double-blind, placebo-controlled, multicenter, outpatient study to evaluate the efficacy and safety of larazotide acetate for the relief of persistent symptoms in adult patients with celiac disease on a gluten free diet.

Official Title
-----------------
A Phase 3, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Larazotide Acetate for the Relief of Persistent Symptoms in Patients With Celiac Disease on a GFD

Conditions
-----------------
Celiac Disease

Intervention / Treatment
-----------------
* Drug: Larazotide
* Drug: Matching Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female adults diagnosed with celiac disease (positive celiac serology plus confirmed biopsy) for at least 6 months On a gluten-free diet for at least 6 months Experiencing symptoms (ie, abdominal pain, abdominal cramping, bloating, gas, diarrhea, loose stool, or nausea) Willing to maintain current gluten-free diet throughout participation in the study Exclusion Criteria: Refractory celiac disease or severe complications of celiac disease Chronic active GI disease other than celiac disease

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Larazotide 0.25 mg<br>Larazotide 0.25 mg capsules TID | Drug: Larazotide<br>* Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules<br>* Other names: INN-202;|
| Active Comparator: Larazotide 0.50 mg<br>Larazotide 0.50 mg capsules TID | Drug: Larazotide<br>* Synthetic 8-amino acid peptide formulated as enteric-coated beads in gelatin capsules<br>* Other names: INN-202;|
| Placebo Comparator: Placebo<br>Matching placebo capsules TID | Drug: Matching Placebo<br>* enteric-coated beads in gelatin capsules<br>* Other names: placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects who are binary responders | Reduction in CeD PRO Abdominal Domain scores | 12 weeks |
Molecular and Functional Neurobiology of Physical Exercise

Study Overview
=================
Brief Summary
-----------------
In this study, we use positron emission tomography (PET) and functional magnetic resonance imaging (fMRI) to study brain mechanisms that contribute to physical exercise-induced reward. We examine whether acute physical exercise releases endogenous opioids in the brain, and whether it modulates brain responses to viewing appetizing foods. Unraveling these mechanism are instrumental from a public health perspective, given the undisputed positive health effects of physical exercise.

Official Title
-----------------
Molecular and Functional Neurobiology of Physical Exercise

Conditions
-----------------
Physical Exercise Behavior (Liking/Aversion)

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Native Finnish speaker Age > 18 years Western Caucasian origin Exclusion Criteria: Age < 18 or > 65 History or current mental disorder BMI > 27 kg/m2 Use of drugs that influence the central nervous system, including nicotine Poor compliance Any chronic medical defect or injury which hinder or interfere everyday life Eating disorder Current or past excessive use of alcohol or substance abuse Past dose of radiation from medical research such that the annual effective dose will exceed 10 mSv Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results Presence of any ferromagnetic objects that would make MR imaging contraindicated

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

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

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: Physical exercise<br> | Behavioral: Exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Binding of [11C]carfentanil in brain confirmed by positron emission tomography | Change in binding of [11C]carfentanil in baseline and 20 min after physical exercise completion | Baseline and 20 min after physical exercise completion |
Infections Related Central Venous Catheters

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to clarify the relationship between SIRS (Systemic inflammatory response syndrome) and the infection associated with the use of central venous catheters at Critical Care center in National Defense Medical College, Japan.

Detailed Description
-----------------
The doctor would remove the inserted catheter from the patient, if the patient shows SIRS. At the same time, the tip of used catheter and blood from the patient are checked whether the pathogenic bacteria exists or not by general bacterial protocol and blood culture test on a routine application. Unfortunately, these tests not always clarified their cause of SIRS. Therefore we conduct this investigation to establish the useful protocol for pathogenic bacteria. We check the pathogenic bacteria not only tip but through the whole catheter in Central Venous Catheter using general bacterial protocol and SEM observation. Additionally, we compared that sputum, urine, skin and blood from the patient for bacteria check.

Official Title
-----------------
Infections Associated With the Use of Central Venous Catheters Related in Critical Care Center.

Conditions
-----------------
SIRS

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: A patient has been inserted with central venous line over 24 hours.

Ages Eligible for Study
-----------------
Minimum Age: 14 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 |
| --- | --- |
| 1<br>Department of Traumatology and Critical Care Medicine, National Defense Medical College | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Culture of bacteria with in central venous catheter. Morbidity and mortality of a patient with multiple resistant bacteria associated with use of the catheter. |  | four months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Central venous catheter, nosocomial infection
The Effect of Alfa-Adrenergic Receptor Blockade on Insulin-Stimulated Forearm Glucose Uptake and Metabolism in Chronic Heart Failure

Study Overview
=================
Brief Summary
-----------------
The activity of the sympathetic nervous system seems to influence the uptake (and handling) of glucose by the skeletal muscle of the forearm. Conditions in which sympathetic activity is increased seem to inhibit/reduce forearm glucose uptake. Inversely a decrease in sympathetic activity seems to increase glucose uptake. This study analyzes the effect of alfa-adrenergic receptor blockade (counteracting sympathetic influence) on insulin-stimulated forearm glucose uptake in patients with increased sympathetic activity (patients with chronic heart failure).

Official Title
-----------------
The Effect of a-Adrenergic Receptor Blockade on Insulin-Stimulated Forearm Glucose Uptake and Metabolism in Chronic Heart Failure

Conditions
-----------------
Heart Failure, Congestive

Intervention / Treatment
-----------------
* Drug: phentolamine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Heart failure of at least New York Heart Association (NYHA) class II Left ventricular ejection fraction (LVEF) <= 40% Age 18-75 years Exclusion Criteria: Alfa-blockers, or beta-blockers with alfa-blocking activity (carvedilol) Tricyclic antidepressants Warfarin derivatives (acetylic salicylic acid and clopidogrel are allowed) Hospitalisation in 6 weeks prior to the study Any change in medication in 6 weeks prior to the study Unstable angina Orthopnoea Known chronic disease of the autonomic nervous system Diabetes mellitus Oedema of the lower extremities, complicating the insertion of a venous catheter in a vein on the foot

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: phentolamine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in glucose uptake |  |  |
Physiological Characteristics of High Altitude Climbers

Study Overview
=================
Brief Summary
-----------------
Climbing at high altitude and tolerating hypoxic environment require specific physiological adaptations. Large intersubjects differences exist regarding the ability to adapt to high altitude and hypoxia. The present study aims to characterise the physiological responses to hypoxia in a group of elite climbers by comparison to sea level athletes. We hypothesised that elite climbers would show better physiological responses to hypoxia and more preserved performances compared to sea level.

Official Title
-----------------
Physiological Characteristics of High Altitude Climbers

Conditions
-----------------
Hypoxia, Exercise, Sport Performance

Intervention / Treatment
-----------------
* Other: Stress test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age between 18 and 40 Member of the national high altitude climbing group Exclusion Criteria: Any diseases incompatible with hypoxic exposure, exercise testing Pregnancy

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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Elite climbers<br>Elite climbers selected in a national group for their previous performances at high altitude | Other: Stress test<br> <br> |
| Other: Sea level sportsmen<br>Control group with similar anthropometric, age, gender and maximal normoxic oxygen consumption that the elite climber group | Other: Stress test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance reduction in hypoxia versus normoxia | Difference in maximal cycling power output between the normoxic and the hypoxic exercise test | Day one on the evaluation day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Near infrared signals during exercise | Differences in cerebral and muscle TOI during exercise between the normoxia and the hypoxic exercise | Day one on the evaluation day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
elite climbers, near infrared spectroscopy
Weight Loss as Treatment in Heart Disease

Study Overview
=================
Brief Summary
-----------------
30 obese moderate-to-severe heart failure patients will be randomized to intervention or control in groups of 5-10 subjects. All will receive dietetic advice according to randomization and according to the European Heart Association. Intervention subjects will initiate with 8 weeks low energy diet, 800-1000 kcal/d by formula diet and subsequent four weeks reintroduction to regular foods supplying 1200 kcal/d substituting two daily meals with formula meal replacement. Control subjects are advised to follow the Nordic Nutrition Recommendations. Patients will be monitored by blood sampling and assessed by change in physical performance.

Official Title
-----------------
Intentional Weight Loss as Treatment in Obese Patients With Ischaemic Heart Disease

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Behavioral: Dietetic group sessions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bmi >30 heart failure, moderate to severe, new york heart association II og III stable disease age >18 years out-patients perform a six minutes walk test given consent Exclusion Criteria: unstable disease insulin treated diabetes pregnancy or lactating unstable weight past 6 months (+- 10 kg) planned procedures in the time of intervention

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: low energy diet<br>low energy diet treatment | Behavioral: Dietetic group sessions<br>* Group sessions to improve dietary adherence<br>|
| Active Comparator: Nordic recommendation<br>Nordic recommendation, no restrictions on energy | Behavioral: Dietetic group sessions<br>* Group sessions to improve dietary adherence<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in six minute walk test from baseline to week 16 (end of study) | Performance measure | weeks 0 and 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in lipid status from baseline to week 16 (end of study). | Blood sample and analyses for lipids | weeks 0,1,2,4,6,8,10,12,14,16 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intention weight loss, heart failure, 6-minute walk test
Penetration and Compartimentation of HIV

Study Overview
=================
Brief Summary
-----------------
Genital mucosa is the main way of HIV penetration. Many cells can be involved (epithelial cells, Langerhans cells) and antibodies may also play a critical role. The investigators' study aims to precise the role of each type of cells, the interaction cell-cell and cell-antibodies.

Detailed Description
-----------------
At inclusion, men will have a two blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm and women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions

Official Title
-----------------
Penetration and Compartimentation of HIV in Genital Mucosa

Conditions
-----------------
HIV

Intervention / Treatment
-----------------
* Other: sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults (> 18 year-old) HIV positive, HIV-CV> 1000 cp/ml, Exclusion Criteria: children

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 |
| --- | --- |
| HIV patients<br>Men will have blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm Women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions | Other: sample<br>* Men will have blood sampling tubes of 10 ml each, a saliva sample and a sample of sperm Women will have a two blood sampling tubes of 10 ml each, a saliva sample and a sampling cervicovaginal secretions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral tropism of HIV | number of HIV virus in sperm or cervical secretions. | Inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Genetic polymorphism for HIV strains | With a sequencing method, it is possible to classify the different strains in groups, according to their polymorphism. | Inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV patients, Genital HIV penetration
A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients

Study Overview
=================
Brief Summary
-----------------
A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.

Official Title
-----------------
A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients

Conditions
-----------------
Pharyngitis Bacterial

Intervention / Treatment
-----------------
* Device: ARIES Group A Strep Assay


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient and/or patient's legal guardian is willing and able to give informed consent and/or assent for extra research sample. The subject's specimen is a throat swab in Liquid Amies based transport medium. The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinical or resident of a long term care facility. The specimen is from a patient for whom a requisition has been made for Group A Strep testing The specimen is from a patient exhibiting clinical signs and symptoms of pharyngitis consistent with Group A Strep infection. The specimen was received in good condition (no leakage or drying of the specimen). The specimen volume is ≥ 850 µL. Exclusion Criteria: The specimen is from a patient who did not provide informed consent/assent. The specimen is not a throat swab collected in Liquid Amies based transport medium. The specimen is from a patient who is undergoing antibiotic treatment. The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 9 below. The specimen volume is < 850 µL.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group A Strep Assay<br> | Device: ARIES Group A Strep Assay<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical performance (sensitivity/specificity) for Group A Strep Assay |  | Day 1 |