linjc16/ctgov huggingface dataset:
The Incretin Effect in Patients With Chronic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
The phenomenon that oral glucose elicits a higher insulin response than does intravenous (iv) glucose, even at identical plasma glucose (PG) profiles (isoglycemia), is called the incretin effect. In type 2 diabetes mellitus (T2DM) the incretin effect has been shown to be markedly reduced or even abolished. It is not known whether the reduced incretin effect in T2DM is a primary event leading to T2DM or if it is merely a consequence of the diabetic state. To answer this question the investigators plan to estimate the incretin effect in 8 patients with secondary diabetes mellitus (DM) to chronic pancreatitis (CP) and compare it to the incretin effect of 8 patients with CP and normal glucose tolerance (NGT). Eight patients with T2DM and 8 healthy control subjects are studied for comparison. The incretin effect is measured by a 50-g oral glucose tolerance test and an isoglycemic intravenous glucose infusion.

Official Title
-----------------
The Incretin Effect in Patients With Chronic Pancreatitis With and Without Secondary Diabetes Mellitus

Conditions
-----------------
Chronic Pancreatitis, Type 2 Diabetes Mellitus

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of chronic pancreatitis with secondary diabetes mellitus Diagnosis of chronic pancreatitis with normal glucose tolerance Diagnosis of type 2 diabetes Normal level of hemoglobin Normal level of se-creatinine Exclusion Criteria: GAD-65 autoantibodies ICA autoantibodies Albuminuria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Tissue Engineering for Hair Follicle Regeneration

Study Overview
=================
Brief Summary
-----------------
This study is to try to maintain cultured dermal papilla cells in spherical structure in vitro before transplanting into dermis in vivo. Also, this study is aimed in clarifying actual mechanism of inducing hair follicle by dermal papilla cells.

Detailed Description
-----------------
Hair transplantation is an well-documented way of treating hair loss. Hair transplantation is based on redistribution of hair follicles without any new follicle formation. It has been long that a lot of researchers have focused on developing skills in regenerating hair follicles. However, cultured dermal papilla cells lose the ability of inducing hair follicle formation after several generations in vitro culture. Our study is aiming in culturing dermal papilla cells in vitro and maintain their spherical structure before transplanting into dermis in vivo. Meantime, this study may help clarify the actual mechanism of inducing hair follicle by dermal papilla cells.

Official Title
-----------------
Study of Tissue Engineering for Hair Follicle Regeneration

Conditions
-----------------
Tissue Engineering, Hair Follicle Regeneration

Intervention / Treatment
-----------------
* Behavioral: Tissue engineering for hair follicle regeneration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients receiving cosmetic surgeries such as removal of moles Exclusion Criteria: No special exclusion criteria

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Tissue engineering for hair follicle regeneration|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Trama-Code (Two Analgesics-comparative Study)

Study Overview
=================
Brief Summary
-----------------
Double-blind randomized study to compare the efficacy of two analgesic drugs(Ixprim®, Dafalgan-Codeine®) in the emergency unit. The efficacy (relief of pain) would be assessed 2 hours after administration of one of the two drugs in a patient presented to the emergency unit with a moderate pain (4 to 6 on pain assessment score).

Official Title
-----------------
Double Blind-randomized Study Comparing the Efficacy of Two Analgesia (Ixprim® and Dafalgan-Codeine®) , in the Emergency Unit.

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

Intervention / Treatment
-----------------
* Drug: Ixprim®
* Drug: Dafalgan-Codeine®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of 18 - 75 years of age Presented to the emergency unit of FOCH hospital Complaining of moderate pain (4-6 on pain assessment scale) evaluated by the reception nurse Exclusion Criteria: Patient already had received another type 2 analgesia or already received one of the study drugs in the last 4 hours pregnant or lactating females Patient with one or more contraindication to one of the study drugs Patients for whom the pain assessment scale can not be performed (unconscious, confused ...) Patient cannot be included for legal reasons Patient required urgent management Patient for whom it is considered difficult to be reassessed 2 hours later Patient unable to swallow

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Ixprim®<br>2 capsules of Ixprim® given orally (1000 mg Paracetamol + 75 mg Tramadol) | Drug: Ixprim®<br> <br> |
| Active Comparator: Dafalgan Codeine®<br>Two capsules of Dafalgan Codeine® given orally (1000 mg Paracetamol + 46.8 mg Codeine) | Drug: Dafalgan-Codeine®<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain improvement |  | 120 minutes |
Enhancing Early-Phase Care for Primary Care Patients With Unhealthy Substance Use

Study Overview
=================
Brief Summary
-----------------
The clinical trial portion of this study tests the hypothesis that contingency management-based incentives for primary care patients with substance use disorders to attend treatment services will increase treatment initiation and engagement. The investigators are investigating whether this approach that has been found effective in specialty treatment settings will work in the primary care context, in conjunction with screening.

Official Title
-----------------
Enhancing Early-Phase Care for Primary Care Patients With Unhealthy Substance Use

Conditions
-----------------
Substance Use Disorders

Intervention / Treatment
-----------------
* Behavioral: incentives


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Positive self-report alcohol or drug use screen in primary care Diagnosis of substance use disorder age 18 or older Exclusion Criteria: SUD treatment in past 60 days cognitive impairment

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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Incentives<br>Prize-based financial incentives, informed by contingency management principles, are offered to patients who attend treatment visits. | Behavioral: incentives<br>* A structured system of prize-based financial incentives rewards attendance at treatment visits.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Initiation | Had initial outpatient treatment visit following positive screen and confirmatory diagnosis | 90 days | 
| Engagement | Had two additional outpatient treatment visits after initiating treatment | 90 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
substance use disorders, substance abuse, substance abuse treatment, contingency management
Memantine Treatment in Fragile X-Associated Tremor/Ataxia Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if memantine is effective in treating symptoms of Fragile X-associated Tremor Ataxia Syndrome.

Official Title
-----------------
Characterization and Treatment of CNS Abnormalities in Premutation Carriers: A Double-Blind Placebo-Controlled Trial of Memantine

Conditions
-----------------
Fragile X-Associated Tremor/Ataxia Syndrome, Fragile X Premutation Carriers

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Fragile X premutation carrier (CGG repeat 55-200)with neurological symptoms; Clinical FXTAS Stage 1-5 Exclusion Criteria: Previous reaction to memantine

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 80 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Memantine<br> | Drug: Memantine<br>* Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.<br>* Other names: Namenda;|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Week 1: Take 5mg tab every morning. Week 2: Take 5mg tab every morning and evening. Week 3: Take 10mg tab in the morning and 5 mg in the evening. Week 4: Take 10 mg tab in the morning and evening, and remain on this dose through the remainder of the study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Executive Functioning as Measured by the Behavioral Dyscontrol Scale II (BDS-II) | The BDS-II is a 9-item, 27-point instrument that measures executive function as the capacity for behavioral and attentional self-regulation. Total score is a sum of the 9 items, with a range of 0-27, in which a higher score indicates a better performance. | One Year | 
| Change From Baseline in Intention Tremor as Measured by the CATSYS Tremor Scale | The CATSYS is a set of computer assisted diagnostic instruments that can measure intention tremor, postural tremor, postural sway, manual coordination and reaction time. The tremor intensity is defined as the root mean square of accelerations, recorded in the 0.9 Hz to 15.0 Hz band during the test period. Unit is measured in m/s2 | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
FXTAS, Fragile X Premutation
Physician Assessment of the Clinical Utility of a Patient-Specific 3D Electro-Anatomical Heart Model in VT Ablation

Study Overview
=================
Brief Summary
-----------------
ACE-VT is a clinical pilot study designed to evaluate the ability of the CardioSolv Software System to generate an output for the physician to review in a timely fashion, consistent with the standard of care VT ablation workflow. This study will assess the acute effectiveness of using the CardioSolv Software System output as additional supporting information during ablation.

Official Title
-----------------
Physician Assessment of the Clinical Utility of a Patient-Specific 3D Electro-Anatomical Heart Model in VT Ablation

Conditions
-----------------
Ischemic Monomorphic Ventricular Tachycardia

Intervention / Treatment
-----------------
* Other: Supporting information.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant meets standard criteria for VT ablation and is scheduled for VT ablation by their cardiologist or electrophysiologist 18 to 85 years of age VT and ischemic cardiomyopathy A pre-procedure MRI with LGE is available (performed within 1 year of procedure, unless an MI has occurred since MRI) with adequate image for analysis Participant is able and willing to provide written informed consent Exclusion Criteria: Contradiction to MRI (except those with MRI compatible pacemaker/ICD/CRT devices implanted or site has approved procedure for MRI of non-compatible devices). Participant implanted with an LVAD. Enrolled in another non-imaging intervention assignment study that could confound the results of this study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Supporting information.|CardioSolv Software System is a software-based medical device meant which creates a patient-specific 3D heart model that provides physiologic information.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Receipt of 3D Heart Model | Verify that the CardioSolv Software System is able to receive and process input data and generate the expected output available for viewing by the physician in less than 24 hours. | 24 hours |
MS PATHS COVID-19 Questionnaire Data Linkage Sub-Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this sub-study is to supplement the Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) dataset with coronavirus disease 2019 (COVID-19)-related health information obtained from periodic participant questionnaires administered by participating MS PATHS institutions.

Official Title
-----------------
Multiple Sclerosis Partners Advancing Technology and Health Solutions (MS PATHS) - COVID-19 Questionnaire Linkage Sub-Study

Conditions
-----------------
Multiple Sclerosis (MS)

Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Be enrolled in MS PATHS under Study 888MS001. Completed one or more COVID-19 questionnaire at a participating MS PATHS institution. Permission for data linkage either obtained when completing a local COVID-19 questionnaire or granted by waiver of informed consent from the local institutional review board (IRB) or ethics committee (EC). Key Exclusion Criteria: 1. Other unspecified reasons that, in the opinion of the Investigator or Biogen, make the participant unsuitable for participation in the sub-study. A participant only needs to complete the assessments deemed necessary by the Investigator. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Participants with multiple sclerosis (MS) or clinically isolated syndrome (CIS) who are enrolled in MS PATHS under Study 888MS001 and have completed at least one COVID-19 questionnaire administered by a participating healthcare institution. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Completed COVID-19 Questionnaires Able to be Linked to a MS PATHS Participant Identifier (ID) |  | Up to 17 months |
Stress Management Training for School Staff

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated.

Detailed Description
-----------------
The purpose of this study is to investigate the outcomes of the Stress Management and Resiliency Training (SMART) program among Public School staff in 2 communities in Minnesota. Feasibility of a blended in-person and online teaching approach of the program will also be evaluated. This study builds on previous work in other working populations with high stress levels inherent in the specific work process.

Official Title
-----------------
The Efficacy of Using Blended Learning With the Stress Management and Resilience Training (SMART) Program to Decrease Stress and Enhance Resilience in Public School Staff

Conditions
-----------------
Stress

Intervention / Treatment
-----------------
* Behavioral: SMART


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Public school teacher Able tor read English Exclusion Criteria: Unable to read English

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: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Stress management<br>Participants will receive SMART traiing | Behavioral: SMART<br>* Paced breathing meditation with cognitive training<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Self reported stress level | Linear analogue scale | 1 year |
Obstructive Sleep Apnea in the Absence of Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
Obstructive Sleep Apnea (OSA) is commonly associated with factors that increase cardiovascular risk, including Metabolic Syndrome (MS). There is a lack of well-controlled clinical studies investigating the independent effects of OSA in the development of cardiovascular disease, especially evaluating jointly mechanisms involved in these disorders such as inflammatory response, oxidative stress and vascular changes. The investigators hypothesized that in the absence of MetS, the mechanisms involved on cardiovascular consequences in OSA patients would be less important. The purpose of this study is to analyze the effects of OSA in the absence of MS, on inflammatory, oxidative stress and vascular markers; to verify the influence of excessive daytime sleepiness (EDS) on the same parameters; and additionally verify the effects of nasal continuous positive airway pressure (nCPAP)in theses parameters.

Official Title
-----------------
Obstructive Sleep Apnea in the Absence of Metabolic Syndrome: Pulse Wave Velocity, Inflammatory and Oxidative Stress Markers

Conditions
-----------------
Obstructive Sleep Apnea

Intervention / Treatment
-----------------
* Procedure: continuous positive airway pressure (CPAP)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male subjects apnea-hypopnea index > 15/h (OSA group) apnea-hypopnea index < 5/h (control group) Exclusion Criteria: body mass index (BMI) > 30 kg/m2 age > 60 years chronic obstructive pulmonary disease cardiac diseases diabetes mellitus metabolic syndrome according to modified National Cholesterol Education Program Adult Treatment Panel III criteria previous OSA treatment

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br> | |
| Experimental: Obstructive sleep apnea<br> | Procedure: continuous positive airway pressure (CPAP)<br>* CPAP pressure is individually prescript according to polysomnography for CPAP titration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory marker (high sensitive C-reactive protein) |  | 3 months | 
| Oxidative stress marker (homocysteine, cysteine and paraoxonase-1 activity) |  | 3 months | 
| Arterial stiffness (pulse wave velocity) |  | 3 months | 
| Angiotensin converting enzyme activity |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obstructive sleep apnea, inflammation, oxidative stress, arterial stiffness