linjc16/ctgov huggingface dataset:
ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients

Study Overview
=================
Brief Summary
-----------------
Sarcoidosis is a multisystem granulomatous disease of unknown cause histologically characterized by noncaseating granulomas. Genetic factors affect disease course, which is highly variable and difficult to predict. This study aims to evaluate the predictive value of ACE and HLA genotypes on disease severity and progression in Danish patients with sarcoidosis.

Official Title
-----------------
ACE and HLA Genotypes Predict Severity and Disease Progression in Danish Sarcoid Patients

Conditions
-----------------
Sarcoidosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of sarcoidosis Signed informed consent Exclusion Criteria: Inability or unwillingness to adhere to the study Inability to give informed consent

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

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to initiation of treatment | Time to initiation of systemic immunosuppression for sarcoidosis | 1 year from diagnosis | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with extrapulmonary organ involvement | Number of participants diagnosed with extrapulmonary organ involvement | 1 year from diagnosis | 
| Change in FEV1 | Increase/ decline/ no change in FEV1 | 1 year | 
| Change in FVC | Increase/ decline/ no change in FVC | 1 year | 
| Change in diffusion capacity | Increase/ decline/ no change in diffusion capacity | 1 year |
Aerosure and Six Minute Walk Distance in Severe COPD

Study Overview
=================
Brief Summary
-----------------
To investigate whether high frequency airflow oscillation (HFAO), delivered using Aerosure, increases six minute walk distance (6MWD) and reduces exertional breathlessness in patients with severe chronic obstructive pulmonary disease (COPD).

Official Title
-----------------
Does High-frequency Airflow Oscillation, Delivered Using Aerosure, Increase Exercise Capacity in Severe Chronic Obstructive Pulmonary Disease?

Conditions
-----------------
COPD

Intervention / Treatment
-----------------
* Device: Aerosure 25 Hz
* Device: Aerosure Sham


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Stable severe COPD (FEV1 < 50% predicted) Modified MRC dyspnoea score 2 or greater At least 10 pack year smoking history Able to mobilise independently Exclusion Criteria: Contraindications to spirometry [1] Contraindications to clinical exercise testing [2] Contraindications to HFAO (see section A.6.3b)) Resting SpO2>88% on air or on patient's usual oxygen prescription Systolic arterial blood pressure (ABP) >200mmHg, diastolic ABP >100 mmHg Cooper, B.G., An update on contraindications for lung function testing. Thorax, 2010. ATS/ACCP Statement on Cardiopulmonary Exercise Testing. Am. J. Respir. Crit. Care Med., 2003. 167(2): p. 211-277.

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Aerosure 25 Hz<br>All subjects receive an active device, sham device (disabled) and no device in a randomised sequence. | Device: Aerosure 25 Hz<br>* Active Aerosure device<br>|
| Sham Comparator: Aerosure sham<br>All subjects receive an active device, sham device (disabled) and no device in a randomised sequence. | Device: Aerosure Sham<br>* Device designed to appear identical to active device but with HFAO mechanism disabled<br>|
| No Intervention: No device<br>All subjects receive an active device, sham device (disabled) and no device in a randomised sequence. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Six minute walk distance (6MWD) |  | up to 6 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| end-6MWD Borg breathlessness |  | after 6 minute walk test | 
| Arterial oxygen saturation (SpO2) |  | At start of 6 minute walk test and after every 1 minute |
ACTIONS - Aortic Counterpulsation to Improve Outcomes in Noncardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The use of the IABP, in addition to standard care, in high-risk cardiac patients undergoing major noncardiac surgery is feasible and may result in improved perioperative outcomes at 30 days compared with standard care alone, while maintaining acceptable safety with respect to vascular accesss-related complications.

Official Title
-----------------
A Multicenter, Randomized, Controlled Pilot Study of Intra-Aortic Balloon Counterpulsation to Prevent Perioperative Cardiac Events in High-Risk Cardiac Patients Undergoing Noncardiac Surgery

Conditions
-----------------
Patients With History of Ischemic Heart Disease With LV Dysfunction Undergoing Noncardiac Surgery

Intervention / Treatment
-----------------
* Device: IABP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients > 18 years with planned elective major abdominal, noncardiac thoracic, head and neck, vascular, or orthopedic surgery and guideline-treated iscehmic heart disease with left ventricular dysfunction (systolic ejection fraction < or = 30%) Exclusion Criteria: Unstable coronary syndromes Decompensated or NYHA Class IV heart failure Hemodynamic instability Cardiac biomarker instability Need for surgical procedure interfering with placement of IABP Cardiogenic shock Septic shock Contraindication to IABP use Clinical need for IABP ASA score > or = 5 Pregnancy Inability to provide informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No IABP<br>Standard of care and no IABP | |
| Active Comparator: Intra-Aortic Balloon Pump (IABP)<br>Standard of care, IABP inserted < or = 3 hours before noncardiac surgery, maintained for > or = 12-24 hours after surgery | Device: IABP<br>* Insertion of intra-aortic balloon < or = 3 hours before noncardiac surgery and maintained > or = 12-24 hours after surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety | Amputation, Clinically significant bleeding, Vascular complications | 30 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy | A composite of the following: All-cause mortality, Cardiovascular mortality, Hemorrhagic or ischemic stroke, New nonfatal myocardial infarction, New or worsening congestive heart failure, Hemodynamically significant arrhythmia requiring intervention | 30 days |
Dario™ Blood Glucose Monitoring System - User Performance Evaluation

Study Overview
=================
Brief Summary
-----------------
The study is performed to evaluate the accuracy of blood glucose level results obtained from fingertip using Labstyle Dario Blood Glucose Monitoring System (BGMS) compared to reference equipment (YSI 2300 STATPLUS) and to evaluate the ease of use of the Dario Device by the lay-person. The participants will review the Dario user manual and guide and will be requested to operate the Dario BGMS and perform their own glucose blood test, after which they will be asked to complete a questionnaire. As reference the participants will be tested by professional caregivers both using the Dario BGMS and by YSI 2003.

Detailed Description
-----------------
Device accuracy will be assessed based on the acceptance criteria of ISO 15197:2003 which states: The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of Reference method at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL).

Official Title
-----------------
Dario™ Blood Glucose Monitoring System - User Performance Evaluation

Conditions
-----------------
Diabetes

Intervention / Treatment
-----------------
* Device: Dario™ Blood Glucose Meter
* Device: YSI2003


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female between the age 18 and 80 Type 1 and Type 2 diabetes Exclusion Criteria: Drug and alcohol abuse Investigator discretion

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dario BGMS<br> | Device: Dario™ Blood Glucose Meter<br>* Each subject will undergo a finger prick and also provide a venous blood sample<br>Device: YSI2003<br>* Blood samples will be tested using YSI (gold standard) for comparison to evaluate accuracy.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| BGMS Accuracy Assessment When Used by Layperson | The minimum acceptable accuracy for results produced by a glucose monitoring system shall be as follows: 95% of the individual glucose results shall fall within 15 mg/dL of the results of reference method (YSI) at glucose concentrations ≥ 4,2 mmol/L (≥ 75 mg/dL). (ISO 15197:2003) | Within 6 seconds of applying blood drop to strip | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluation of the Ease of Use of the Dario BGMS by the Lay-person | Each participant receives a survey to fill in describing their usage of the device and their opinions on the ease of use. | Within a couple of hours from the time labelling material was provided to the subject |
Biomarker Testing and DNA Collection in Subjects Participating in Protocol 22001

Study Overview
=================
Brief Summary
-----------------
The subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 will be offered participation in 22001A which will evaluate secreted protein before and after treatment with STX209 and placebo to determine if they correlate with effectiveness of treatment or susceptibility to treatment with STX209. These same subjects will also be asked to contribute a blood sample for DNA (deoxyribonucleic acid) collection. The investigators will study the DNA to determine if STX209 works better in people with specific gene variations, or to find new gene variations that predict how well STX209 works.

Official Title
-----------------
Biomarker Testing and DNA Collection in Subjects Participating in a Double-Blind, Placebo-Controlled, Crossover, Flexible-Dose Evaluation of the Efficacy, Safety, and Tolerability of STX209 in the Treatment of Irritability in Subjects With Fragile X Syndrome

Conditions
-----------------
Fragile X Syndrome

Intervention / Treatment
-----------------
* Drug: STX209


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001 Exclusion Criteria: Subjects that meet the inclusion and exclusion criteria and consent to participate in protocol 22001

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum 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 |
| --- | --- |
| Arbaclofen followed by Placebo<br> | Drug: STX209<br> <br> |
| Placebo followed by Arbaclofen<br> | Drug: STX209<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in plasma proteins with treatment |  | After 4 weeks of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fragile X syndrome, biomarkers
Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD

Study Overview
=================
Brief Summary
-----------------
To provide ruxolitinib through an expanded access to treat a single patient with cGVHD

Official Title
-----------------
Expanded Access of Ruxolitinib Cream to Treat a Single Patient With cGVHD

Conditions
-----------------
Graft-versus-host Disease (GVHD)

Intervention / Treatment
-----------------
* Drug: Ruxolitinib


Participation Criteria
=================
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Ruxolitinib|Ruxolitinib Cream|

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
-----------------
ruxolitinib, acute or chronic steroid-refractory GVHD, hematopoietic stem cell transplantation (allo-HSCT)
Study of the Pronostic Impact of Immunohistochemical, Histological and Radiological Factors in Patients With Primary Central Nervous System Lymphoma.

Study Overview
=================
Brief Summary
-----------------
Primary Central Nervous System Lymphoma (PCNSL) have a specific mutational profile in comparison to systemic diffuse large cells lymphoma (DLBCLs) that can be related to the expression of immunohistochemical markers as cyclon, NPM1, CD30, and P53 which could be predictive factor for prognosis and/or chemotherapy response. The main objective of this study is to identify new prognostic factors and new potential therapeutic targets. The secondary objectives are to correlate the histological, the radiological and the clinical's informations of these patients.

Official Title
-----------------
Study of the Pronostic Impact of Immunohistochemical, Histological, Radiological and Molecular Factors in Patients With Primary Central Nervous System Lymphoma

Conditions
-----------------
Rare Disease With Poor Outcome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PCNSL diagnosed between January 2011 and December 2019, without regard to the clinical outcome. Age > 18 Exclusion Criteria: Systemic DLBCL

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| correlation between the survival and the expression of Cyclon, NPM1 and CD30. | kaplan meyer | 17/10/2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the correlation between the molecular abnormalities and the expression of Cyclon, NPM1 and CD30 | mutational signature | 17/10/2022 |
The Food Intake, Satiety and Blood Glucose After Ingestion of Potato Chips Produced From Three Potato Cultivars

Study Overview
=================
Brief Summary
-----------------
Potato is one of the world's most popular foods and is widely accepted as a staple food. The objective of this study is to determine the effect of consuming potato chips from different cultivars on blood glucose, subjective appetite and food intake. It is hypothesized that the chips produced from various potato cultivars will differ in their effect on blood glucose, satiety and food intake.

Conditions
-----------------
Obesity, Overweight, Diabetes, Metabolic Syndrome

Intervention / Treatment
-----------------
* Other: dietary treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men with a body mass index (kg/m2) of 20-24.9 Exclusion Criteria: smocking, medication, breakfast skipping, restrained eating

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Prevention


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atlantic Western chips<br>deep fried potato chips | Other: dietary treatment<br> <br> |
| Experimental: Dakota Pearl chips<br>deep fried potato chips | Other: dietary treatment<br> <br> |
| Experimental: Andover Ontario chips<br>deep fried potato chips | Other: dietary treatment<br> <br> |
| Experimental: white bread with margarine<br>energy control | Other: dietary treatment<br> <br> |
| Experimental: white bread<br>control | Other: dietary treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood glucose | Glycaemic response will be measured before the treatment (baseline) and at 15, 30, 45, 60, 90 and 120 min after the treatment. The glucose concentration will be measured in capillary blood using portable glucose meter. | 120 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| food intake | Ad libidum food intake will be measure at 120 min using test pizza meal. The amount of consumed test meal (g) will be converted to the energy (kcal). | 120 min |
MRS and 11C-methionine PET/CT in the Diagnosis of Glioma

Study Overview
=================
Brief Summary
-----------------
MET PET and MRS are often performed as imaging tool for the differential diagnosis of gliomas. But both techniques have limitations causing misdiagnosis; thus, the investigators tried to combine these two imaging tools to study whether the combination of MET PET and MRS could raise the diagnosis ability of the radiological diagnosis of gliomas.

Official Title
-----------------
Combination of 11C-MET PET and MRS in the Diagnosis of Glioma.

Conditions
-----------------
Glioma

Intervention / Treatment
-----------------
* Other: tumors are confirmed by surgery and pathology


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with non-enhancing supratentorial lesions shown by contrast-enhanced MRI No surgery, chemotherapy or radiotherapy history All patients gave written informed consent. Exclusion Criteria: Patients with infratentorial Neoplasms Patients with enhancing supratentorial lesions Recurrent gliomas after surgery Primary gliomas with history of radiotherapy or chemotherapy History of malignant tumours at any body site Inability to give informed consent

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MRS imaging and 11C-MET PET/CT<br>Each patient underwent both MRS and MET PET before surgery. | Other: tumors are confirmed by surgery and pathology<br>* Each patient undergoes both MRS and MET PET scan before surgery. The lesion will be considered as a glioma when either MRS or MET PET results indicated the diagnosis. Pathologic diagnosis will be performed to confirm the final diagnosis.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of the combination of MRS and 11C-MET PET/CT |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The relationship between 11C-MET PET/CT results and molecular pathogeneses |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Glioma, Magnetic resonance spectroscopy, Methionine, PET/CT
Efficacy, Safety, and Immunogenicity of Subcutaneous DMB-3115 Versus Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis

Study Overview
=================
Brief Summary
-----------------
This study is designed to evaluate efficacy, safety, pharmacokinetics (PK) and immunogenicity of subcutaneously administered DMB-3115 in comparison with Stelara for treatment of moderate to severe chronic plaque psoriasis.

Official Title
-----------------
A Randomized, Double-Blind, Multicentric, Parallel Group Therapeutic Equivalence Study Comparing Efficacy, Safety and Immunogenicity of Subcutaneous DMB-3115 and Stelara® in Patients With Moderate to Severe Chronic Plaque Psoriasis

Conditions
-----------------
Moderate to Severe Chronic Plaque Psoriasis

Intervention / Treatment
-----------------
* Drug: DMB-3115
* Drug: Stelara


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who have a diagnosis of plaque-type psoriasis for at least 6 months. Exclusion Criteria: Patients with hypersensitivity to ustekinumab or any of the product excipients.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DMB-3115<br>Patients randomized to receive DMB-3115 at the beginning of the study will continue to receive the same treatment | Drug: DMB-3115<br>* 45mg or 90mg dose subcutaneous administration<br>|
| Active Comparator: Stelara<br>Patients randomized to receive Stelara at the beginning of the study will be re-randomized at Week 28 in a 1:1 ratio to either continue on Stelara or will be transitioned to receive DMB-3115 | Drug: DMB-3115<br>* 45mg or 90mg dose subcutaneous administration<br>Drug: Stelara<br>* 45mg or 90mg dose subcutaneous administration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • To evaluate efficacy of DMB-3115 in comparison with Stelara | Percent change in the Psoriasis Area and Severity Index (PASI) score | Week 8 (For EMA) and 12 (For FDA) |