linjc16/ctgov huggingface dataset:
Neural Correlates of Acute Pain Dynamics

Study Overview
=================
Brief Summary
-----------------
This work aims to study the neural correlates and determinants of pain dynamics related to changes in a noxious stimulus.

Official Title
-----------------
The Neural Correlates of and Effects of Methylphenidate on Acute Pain Dynamics

Conditions
-----------------
Pain

Intervention / Treatment
-----------------
* Drug: Methylphenidate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Exclusion Criteria: Pregnant History of chronic pain History of neurological diagnosis History of psychiatric diagnosis

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Methylphenidate<br> | Drug: Methylphenidate<br>* 0.35 mg/kg methylphenidate will be administered after baseline testing and 45 min-1 hr before post-intervention testing.<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo for methylphenidate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of methylphenidate on acute pain dynamics | We will compare acute pain dynamics-i.e., the time series of pain visual analog scale ratings (0-100, where 0 = no pain and 100 = worst pain imaginable) obtained while delivering a changing noxious stimulus-during the methylphenidate condition to that of the placebo condition. | 6 months | 
| Nucleus accumbens activation with acute pain dynamics | We will regress the time course of nucleus accumbens BOLD activity onto the latent time series obtained from our valence competition model. This will be supported by regressing the nucleus accumbens time course onto the pain VAS time course, allowing our findings to be compared to standard analyses in the literature. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Mesolimbic system, Dopamine circuits, Psychophysics
Safety and Performance of Optivantage Multi-use When Injecting Contrast Media for Contrast Enhanced CT Examination

Study Overview
=================
Brief Summary
-----------------
The study is a prospective, single-arm observational multicenter clinical investigation. The primary objective is to confirm the safety and performance of the Optivantage® Injection System when injecting contrast media to subjects requiring contrast-enhanced CT imaging, in multi-patient use.

Detailed Description
-----------------
Each subject will undergo CT examination in multi-use context using Optivantage Dual-head Contrast Delivery System. 100 subjects are expected to be enrolled. The safety and performance of the injector will be evaluated.

Official Title
-----------------
Safety and Performance of Optivantage Multi-use Solution When Injecting Contrast Media to Subjects Requiring Contrast Enhanced CT Examination

Conditions
-----------------
Patient Participation

Intervention / Treatment
-----------------
* Device: CT examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject referred for a contrast-enhanced CT examination using a power injector Subject or legal representative for children, having provided written informed consent Exclusion Criteria: Subject weighting less than 10 kg Pregnant or breastfeading woman subject Subject with known allergy or hypersensitivity to contrast media Subject has contra-indication(s) to CT scanner and/or contrast medium as per the Summary of Product Characteristics Subject with peripherally inserted central catheter, central venous line, or port-A-catheter inserted for injection Subject unlikely to comply with the CIP, e.g. uncooperative attitude and unlikelihood of completing the study

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: CT examination|Administration of contrast medium using the power injector|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Optivantage | Rate of extravasation | Per procedure | 
| Performance of Optivantage | Success of injection | Per procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of Optivantage | Rate of patient complications | Per procedure | 
| Device deficiencies | Rate of device deficiencies including malfunction and error use | Per procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Safety, Performance, Power Injector, Optivantage
Sidestream Dark-Field (SDF) Imaging of the Intestinal Microcirculation

Study Overview
=================
Brief Summary
-----------------
Sepsis is the most frequent cause of death in critically ill patients in non-coronary care Intensive Care Units in the developed world. Microcirculatory disturbances are central to the development of the disorder, leading to organ dysfunction, multi-organ failure and fatal outcome. In particular the intestinal microcirculation is impaired early in the course of the disease. This may result in a breakdown of the gut barrier function with translocation of bacteria and their toxins into the systemic circulation, thus sustaining a gut derived septic state. Therefore, the impaired intestinal microcirculation has been suggested to act as the motor of multiple organ failure in sepsis. The aim of the project is to evaluate a new diagnostic tool and the impact of Activated Protein C administration on the intestinal microcirculation in patients with severe sepsis and compare the findings with septic patients who are not candidates for APC therapy and healthy patients post bowel surgery using an innovative diagnostic tool (side stream dark-field imaging, SDF).

Official Title
-----------------
Sidestream Dark-Field Imaging of the Intestinal Microcirculation in Clinical Sepsis: The Impact of Activated Protein C Therapy

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ileostomy, no infection at the site of stoma, informed consent. diagnosed sepsis according to American College of Chest Physicians/Society of Critical Care Medicine criteria13. indication for treatment according to hospital guidelines Exclusion Criteria: infection at the site of stoma, moribund patients

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Controls<br>Patients with ileostomy. | |
| Standard Sepsis Treatment<br>Patients with ileostomy and sepsis | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microvascular Flow Index (MFI) |  | 6 hours after treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leukocyte - endothelial cell interactions, red blood cell velocity |  | 6 hours after treatment |
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

Study Overview
=================
Brief Summary
-----------------
This study investigate the relationship between regional brain volume measured by MRI and donepezil treatment response in patients with Alzheimer's Disease.

Official Title
-----------------
Correlation Between Regional Brain Volume and Response to Donepezil Treatment in AD Patients

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Drug: DONEPEZIL HYDROCHLORIDE


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Over 60 years old. Probable or possible Alzheimer's Disease according to the DSM-IV and NINCDS-ADRDA. MMSE score of 10 24, CDR of 1 2. Patients didn't take acetylcholinesterase inhibitors 4 weeks before screening. Permitted drugs: antipsychiatric drug for BPSD, antidepression drug, tranquilizer, treatment drug for physical disease for example hypertension. Exclusion criteria: Uncontrolled by donepezil because of adverse events. No longer continuing treatment of donepezil for refuse, drug-drug interaction etc. If they have taken concomitant medication which were not allowed.

Ages Eligible for Study
-----------------
Minimum Age: 60 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: 1<br> | Drug: DONEPEZIL HYDROCHLORIDE<br>* One 5mg table, once daily. (After 4 weeks treatment, the dose can be increased 10mg once daily.)<br>* Other names: Aricept;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRI, ADAS-cog |  | 0, 12, 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ADL, BPSD, CDR-SB, ZBI, GHQ, CIBIC plus |  | 0, 12, 24 weeks |
Weight Loss on the Web: A Pilot Study Comparing a Commercial Website to a Structured Behavioral Intervention

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study was to compare weight loss achieved through a behavioral online intervention vs. a commercial self-help website. The investigators hypothesized that there would be no difference in weight loss between groups.

Detailed Description
-----------------
Obesity has reached epidemic proportions in the United States. Novel approaches are needed to address this issue on a broad scale. The internet holds promise as a way to disseminate effective weight loss strategies. The primary purpose of this study was to compare weight loss achieved through a behavioral online intervention vs. a commercial self-help website. A second aim was to evaluate the utilization of web components and their relationship to weight loss between groups and within groups in order to determine what aspects of web usage correlate to weight loss.

Conditions
-----------------
Obesity, Diet Therapy, Weight Loss

Intervention / Treatment
-----------------
* Behavioral: behavior modification for weight loss


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI between 25 and 39.9 kg/m2 18 or older Exclusion Criteria: Planned to move within 1 year Planned a pregnancy within 1 year Take medications with weight implications Unable to exercise moderately Participating in another weight loss program Lacked minimum computer requirements

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: behavior modification for weight loss|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| weight change |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| social influence components |  |  | 
| eating behavior |  |  | 
| web usage correlation to weight change |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
internet, weight management, behavior therapy, self-help, commercial program, obesity
Study to Determine if Avonex and Rebif Work Comparably Well in Subjects With Relapsing Multiple Sclerosis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to find out if weekly Avonex works as well as three times a week Rebif in subjects with relapsing multiple sclerosis.

Detailed Description
-----------------
This is a Phase 4, multicenter, prospective and retrospective, long-term observational study of Avonex® and Rebif® to determine the efficacy, tolerability, and safety in subjects with relapsing MS.

Official Title
-----------------
A Multicenter, Prospective and Retrospective, Long-Term Observational Study of AVONEX® and Rebif® to Determine the Efficacy, Tolerability, and Safety in Subjects With Relapsing Multiple Sclerosis (MS)

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

Intervention / Treatment
-----------------
* Drug: Interferon beta-1a
* Drug: Interferon beta-1a


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have been receiving AVONEX® or Rebif®. Must have a confirmed diagnosis of relapsing-remitting MS using the Poser criteria. Must have experienced at least 2 relapses within the 3 year period prior to the initiation of treatment. Must have an EDSS score of 0.0 to 5.5, inclusive. Exclusion Criteria: History of severe allergic or anaphylactic reaction or hypersensitivity to human albumin, to any interferon, or to other components of the drug formulation. History of poorly controlled hypertension and/or other clinically significant major disease. History of uncontrolled seizures within the 3 months prior to enrollment. History of suicidal ideation or an episode of severe depression within the 3 months prior to enrollment. Serious local infection or systemic infection within 8 weeks prior to enrollment. Treatment with certain other agents to treat MS symptoms or underlying disease. Treatment with any investigational product Previous participation in this study. Other Protocol-defined inclusion/exclusion criteria may apply.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>This group was treated with Avonex once a week | Drug: Interferon beta-1a<br>* injection once a week<br>* Other names: Avonex;|
| B<br>This group was treated with Rebif three times a week | Drug: Interferon beta-1a<br>* injection three times a week<br>* Other names: Rebif;|

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
-----------------
Multiple Sclerosis, Interferon beta 1a, Avonex
The Midwest Head and Neck Cancer Consortium Multi-Institutional Parathyroid Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to create a database that collects clinical data to improve knowledge about primary hyperparathyroidism.

Detailed Description
-----------------
This will be a multi-institutional prospective study in which patients that have undergone parathyroidectomy with intra-operative PTH assessment. The success of minimally invasive parathyroidectomy without and with intra-operative PTH will be assessed for each patient. Success for exploration without intra-operative PTH will be defined as directed exploration with detection of an abnormal parathyroid in the location suggested by imaging. Success with intra-operative PTH will be defined as per standard protocols (50% or > decrease in intra-operative PTH following excision).

Official Title
-----------------
The Midwest Head and Neck Cancer Consortium Multi-Institutional Parathyroid Registry

Conditions
-----------------
Primary Hyperparathyroidism

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult individuals (male and female) who have a personal diagnosis/history of primary hyperparathyroidism. Age 19 or greater. Patients who are seen and treated surgically at UNMC's Department of Otolaryngology- Head Neck Surgery . Able to provide informed consent. Exclusion Criteria: -No history of primary hyperparathyroidism

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hyperparathyroidism, Hypercalcemia
Identification of Biomarkers for Severe Pneumonia

Study Overview
=================
Brief Summary
-----------------
To identify the potential serum biomarkers with regard to the severity of pneumonia, and to further evaluate the prognostic value of these markers.

Detailed Description
-----------------
First, we will collect serum samples from patients with pneumonia. Then we will identify biomarkers differentially expressed between non-severe pneumonia and severe pneumonia. We will further evaluate the prognostic value of these markers for pneumonia.

Official Title
-----------------
Shanghai Changhai Hospital,Second Military Medical University

Conditions
-----------------
Biomarkers

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - under 18 years old Exclusion Criteria: over 80 years old

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| microRNA | the all of microRNA of blood plasma | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biomarkers pneumonia severity
Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease (SCD-TGA)

Study Overview
=================
Brief Summary
-----------------
Sickle cell disease (SCD) is an inherited haemoglobinopathy disorder caused by mutations in HBB gene with amino-acid substitution on β globin chain. The consequence is synthesis of altered haemoglobin S (HbS) which polymerises in red blood cell (RBC) at deoxygenated state. SCD is associated with chronic haemolytic anaemia, vaso-occlusive crisis (VOC) leading to frequent hospitalisation. The aim of the study was to to investigate whether a combination of routine laboratory biomarkers of haemolysis could be used to predict VOC development in confirmed SCD patients.

Official Title
-----------------
Study of Erythrocyte Parameters and Hypercoagulability in Sickle Cell Disease

Conditions
-----------------
Sickle Cell Disease, Vaso-occlusive Crisis

Intervention / Treatment
-----------------
* Biological: Erythrocytic parameters and thrombin generation assay measurement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sickle cell disease Exclusion Criteria: <18 years pregnancy Patient under protective guardianship or curatorship

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Sickle cell disease<br>Confirmed sickle cell disease withHaemoglobin profile was determined by high performance liquid chromatography (HPLC) (Variant II Biorad, California, United States), by capillary electrophoresis on Capillarys 3 Octa® (Kit hydragel hémoglobine Sebia, Lisses, France) and iso-electrofocalisation. Patients were included during injury evaluation in our tertiary centre. | Biological: Erythrocytic parameters and thrombin generation assay measurement<br>* Erythrocytic parameters and thrombin generation assay measurement<br>|
| Healthy<br>25 healthy controls matched on age and gender | Biological: Erythrocytic parameters and thrombin generation assay measurement<br>* Erythrocytic parameters and thrombin generation assay measurement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospitalisation for Vaso-occlusive crisis within one years | Following injury consultation, evaluation of biological markers predicting vaso-occlusive crisis requiring hospitalisation in the year | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
sickle cell disease, vaso-occlusive crisis, reticulocyte count, thrombin generation assay, hypercoagulability
Randomised Double Blind Placebo Controlled Cross Over Design of the Efficacy of Topical Morphine for Inflammatory Pain in Children With Epidermolysis Bullosa

Study Overview
=================
Brief Summary
-----------------
Randomised Double blind placebo controlled cross over design study of the efficacy of morphine for inflammatory pain in children with Epidermolysis Bullosa

Conditions
-----------------
Epidermylosis Bullosa

Intervention / Treatment
-----------------
* Drug: topical opiod
* Drug: morphine sulphate in intrasite gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children under 18 years epidermolysis wounds requiring dressing changes

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum 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: Crossover Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: topical opiod|nan|
|Drug: morphine sulphate in intrasite gel|nan|

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

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