linjc16/ctgov huggingface dataset:
Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
High inspiratory oxygen fractions are known to induce oxidative stress and lipid peroxidation. The degrading products of oxidative stress induced lipid peroxidation are in part volatile and appear in breath where they can be measured non-invasively. However, there is lack of knowledge on the correlation of blood and breath biomarkers of oxidative stress. This study aims to investigate the effects of a high inspiratory oxygen fraction on oxidative stress in healthy volunteers. The primary outcome is the appearance of exhaled breath biomarkers of oxidative stress by electrochemical sensors and ion mobility mass spectrometry. Secondary outcomes are changes in oxidative stress biomarkers in blood and their relationship to breath biomarkers.

Official Title
-----------------
Impact of Inspired Oxygen on Oxidative Stress and Breath Volatile Organic Compound Composition in Healthy Volunteers: A Randomized Controlled Cross-over Trial

Conditions
-----------------
Oxidative Stress

Intervention / Treatment
-----------------
* Other: Oxygen
* Other: Ambient


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: healthy male volunteers who have given an oral and written informed consent Exclusion Criteria: smoker or ex-smoker any pulmonary disease any heart disease any chemotherapy in the past any kind of daily medication

Ages Eligible for Study
-----------------
Minimum Age: 25 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
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxygen<br>Day 1: breathing of 100% oxygen; Day 2: ambient air breathing | Other: Oxygen<br>* breathing oxygen<br>Other: Ambient<br>* breathing ambient air<br>|
| Experimental: Ambient<br>Day 1: breathing of 100% oxygen; Day 2: ambient air breathing | Other: Oxygen<br>* breathing oxygen<br>Other: Ambient<br>* breathing ambient air<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in exhaled breath oxidative stress biomarker | Measurement of oxidative stress biomarkers in breath e.g. acetaldehyde, ethan, malondialdheyde, propionaldehyde, pentane | 1, 4, and 24 hour | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in blood oxidative stress biomarkers | Measurement of oxidative stress biomarkers in blood e.g. ethane, malondialdehyde, pentane, propionaldheyde, total oxidative and antioxidative capacity, glutathione | 1, 4, and 24 hour |
Extensive Mesenteric Excision (EME) Versus Local Mesenteric Excision (LME) for Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
Crohn's patients receiving ileocolonic resection are randomized into extensive mesenteric resection group and local mesenteric resection group.

Detailed Description
-----------------
Randomization was performed intraoperatively once the surgeon had determined that there were no other sites of disease and that either type of anastomosis could be performed safely. Computer generated randomization was carried out within strata using randomized permuted blocks to ensure balance of the groups. All surgery was performed by a single group of surgeons experienced in the surgical treatment of Crohn's disease. Surgery was performed open or laparoscopically depending on patient factors and surgeon preference. The resection was performed grossly normal resection margins, with side-to-side anastomosis. The presence of mesenteric marginal thickening with confirmation by naked eye assessment of the mucosal aspect of the bowel were used to establish the limits of the disease.

Conditions
-----------------
Postoperative Disease Recurrence, Crohns Disease

Intervention / Treatment
-----------------
* Procedure: mesenteric excision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crohn's disease limited to the distal ileum and/or right colon Exclusion Criteria: Concomitant anastomosis/strictureplasty at another site of the gastrointestinal tract, and required a temporary fecal diversion

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: LME<br>the anastomosis was performed as stapled side-to-side with local excision of the mesenteric tissue adjacent to the diseased bowel | Procedure: mesenteric excision<br> <br> |
| Active Comparator: EME<br>the anastomosis was performed as a stapled side-to-side anastomosis with extensive excision of mesenteric tissue. | Procedure: mesenteric excision<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative endoscopic recurrence |  | 12 months |
Effect of Post-operative Brace on Pain and Patient Outcomes Following Hip Arthroscopy for FAIS

Study Overview
=================
Brief Summary
-----------------
The routine application of hip brace following hip arthroscopy for femoroacetabular impingement syndrome (FAIS) has no proven clinical benefits. This study will investigate whether the application of hip brace affects the post-operative course and patient reported outcomes in patients undergoing hip arthroscopy for FAIS.

Official Title
-----------------
Effect of Post-operative Brace on Pain and Patient Outcomes Following Hip Arthroscopy for FAIS: A Randomized Study

Conditions
-----------------
Hip Arthroscopy

Intervention / Treatment
-----------------
* Other: Brace


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient age of 18 years or older Patients with femoroacetabular impingement syndrome (FAIS) and who are candidates for surgical treatment with hip arthroscopy Exclusion Criteria: Patient age < 18 years Patients with FAIS who are not surgical candidates (surgical therapy is not indicated) Patients with previous, ipsilateral hip procedures

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Brace<br> | Other: Brace<br>* Brace following hip arthroscopy<br>|
| No Intervention: No Brace<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hip Outcome Score |  | up to 1 year |
Multiparametric Characterization of Orbital Tumors by MRI

Study Overview
=================
Brief Summary
-----------------
Prospective study on patients with orbital tumors of unknown origin. Aim of the study is to differentiate benign from malignant tumors upon MR imaging. Magnetic resonance imaging of the orbit will be performed including standard morphological sequences and advanced sequence techniques. These advanced sequence techniques may allow to differentiate benign from malignant tumors based on their cellularity and vascularity (diffusion and perfusion imaging). These MRI data will be analysed and the level of diffusion and perfusion will be measured and compared to the histological findings. Cut-off values of diffusion and perfusion will be calculated that allow to separate benign from malignant tumors.

Conditions
-----------------
Orbital Tumors

Intervention / Treatment
-----------------
* Other: MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: non-diagnosed orbital tumors Exclusion Criteria: any metal implants, non-MRI compatible age below 18 pregnancy recent surgery recent severe medical diseases

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 |
| --- | --- |
| orbital tumors<br> | Other: MRI<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| multiparametric characterization of orbital tumors by MRI | The level of diffusion and perfusion (multiparametric characterization) of the orbital tumors will be measured and the outcome measure is the ability of diffusion and perfusion imaging to predict malignancy. These parameters will be compared to histopathology in terms of separating benign vs. malignant tumors. | 24 months |
ImpACT for Developmental Coordination Disorder

Study Overview
=================
Brief Summary
-----------------
This study investigates the impact of Developmental Coordination Disorder on the child and its environment in Belgium within the following domains: diagnosis, activities and participation, school, therapy/support, and socio-emotional impact.

Official Title
-----------------
ImpACT for Developmental Coordination Disorder

Conditions
-----------------
Developmental Coordination Disorder

Intervention / Treatment
-----------------
* Other: Online questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Parents of children living in Belgium Parents of children between 4 and 18 years old Parents of children who experience movement problems and/or there is a suspicion or diagnosis of DCD Exclusion Criteria: • Parents of children who have another other medical condition that would explain the movement difficulties (e.g. cerebral palsy, muscle disease,...)

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Parents of children with DCD or related movement difficulties<br> | Other: Online questionnaire<br>* Online questionnaire impact for DCD - Belgian version<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of Developmental Coordination Disorder (DCD) | This translated and culturally adapted questionnaire will investigate the following domains: diagnosis, activities and participation, school, therapy/support, and socio-emotional impact. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Child, Diagnostics, Early development, Neurodevelopmental disorders
The Study of Relationship of Plasma Concentrations of Folic Acid, Vitamin B and Homocysteine With Carotid Atherosclerosis and Endothelium-Dependent Vasodilatation of Geriatric and Young Patients in the Ambulatory Care Department of NTUH

Study Overview
=================
Brief Summary
-----------------
Elevation of plasma homocysteine has been recognized as one of the risk factors of atherosclerotic disease. The objectives of this study are: (1) to investigate the level of plasma homocysteine and the prevalence of hypehomocysteinemia (2) to find out the role of homocysteine in coronary artery disease and the proper cut-off point of plasma homocysteine to evaluate the presence of coronary artery disease; (3) to understand the control condition of tranditional risk factors of cardiovascular disease, especially hypertension, dyslipidemia, and diabetes mellitus. The study subjects were recruited from the ambulatory setting of cardiology in National Taiwan University Hospital.

Conditions
-----------------
Homocysteine, Coronary Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient > 65 y/o or < 50y/o Scr<=1.5mg/dL Exclusion Criteria: Scr> 1.5mg/dl pregnancy alcohoism

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Safety Extension Study of Oral Edaravone Administered in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Study Overview
=================
Brief Summary
-----------------
This is a Phase 3, international, multicenter, open-label, long-term extension study. The primary objective of this study is to evaluate the long-term safety and tolerability of oral edaravone in subjects with Amyotrophic Lateral Sclerosis (ALS) for up to 96 weeks.

Official Title
-----------------
A Phase 3, Multi-center, Open-label, Safety Extension Study of Oral Edaravone Administered Over 96 Weeks in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Conditions
-----------------
Amyotrophic Lateral Sclerosis (ALS)

Intervention / Treatment
-----------------
* Drug: MT-1186


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must provide signed and dated informed consent form (ICF) to participate in the study. Subjects must be able (in the judgment of the Investigator) to understand the nature of the study and all risks involved with participation in the study. Subjects must be willing to cooperate and comply with all protocol restrictions and requirements. Subjects who successfully completed Study MT-1186-A01 Exclusion Criteria: Subjects of childbearing potential unwilling to use a highly effective method of contraception from Visit 1 until 3 months after the last dose of study medication. Subjects who have a significant risk of suicide. Subjects with any suicidal behavior or suicidal ideation of type 4 (active suicidal ideation with some intent to act, without a specific plan) or type 5 (active suicidal ideation with specific plan and intent) based on the C-SSRS at Visit Subjects who are not eligible to continue in the study, as judged by the Investigator. Subjects who are unable to take their medications orally or through a PEG/RIG tube.

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
Interventional Model Description: Single Arm Open Label
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MT-1186<br>Oral Edaravone administered once daily for 10 days out of 14, followed by a 14-day drug- free period | Drug: MT-1186<br>* Treatment cycles with daily dosing for 10 days out of a 14-day period, followed by a 14 day drug free period up to 96 weeks of treatment or until the drug is commercially available in that country.<br>* Other names: Oral Edaravone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and tolerability as measured by incidence of Adverse events (AEs), adverse drug reactions (ADRs), and treatment-emergent adverse events ([TEAEs]) |  | Baseline to Week 96 |
Evaluation of the Bioavailability of Pramlintide

Study Overview
=================
Brief Summary
-----------------
This is a randomized, open-label, crossover study to examine the bioavailability of pramlintide in normal weight and overweight subjects with type 1 and type 2 diabetes mellitus using insulin.

Conditions
-----------------
Diabetes Mellitus, Type 1, Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Pramlintide acetate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HbA1c value between 6-12% BMI <= 27 kg/m2 or BMI >=30 to <= 45 kg/m2 Consistent insulin regimen for 2 months prior to screening

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Pramlintide acetate (AC137) injection<br>Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection. | Drug: Pramlintide acetate<br>* Pramlintide acetate (AC137) injection is a clear, colorless, sterile solution for injection. It consists of pramlintide in sodium acetate buffer, pH 4.0, containing 43mg/mL mannitol as an iso-osmolality modifier and 2.25 mg/mL metacresol as a preservative. The strength of pramlintide is 1.0 mg/mL for SC injection and 0.6 mg/mL for IV bolus injection.<br>* Other names: Symlin (pramlintide acetate);|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of varying needle length on bioavailability of Pramlintide | To determine the effect of various anatomical injection sites and varying needle lengths upon the absolute bioavailability of pramlintide when injected subcutaneously (SC) in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin. | approximately 6days but not to exceed 14days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Effect of varying needle length on safety and tolerability of Pramlintide | To assess the safety and tolerability of pramlintide when injected SC at various anatomical sites and with various needle lengths in non-obese and obese subjects with type 1 and type 2 diabetes mellitus using insulin | Approximately 6 days not to exceed 14days |
Energy Specific Far Infrared Radiation Treatment for Sciatica

Study Overview
=================
Brief Summary
-----------------
A preliminary study to determine the use of far infrared radiation for the treatment of back pain

Detailed Description
-----------------
Sciatica is created by joint misalignment, muscle spasm and inflammation. Generally, sciatica is a combination of lower back pain, pain radiating into the buttock and possibly down the leg. Far infrared radiation of the sciatic nerve, coupled with the stretching of the spinal cord, is a promising non-invasive method for treating sciatica.

Official Title
-----------------
Phase 1 Study to Evaluate the Efficacy of Using Energy Specific Far Infrared Radiation Treatment for Sciatica.

Conditions
-----------------
Sciatica

Intervention / Treatment
-----------------
* Radiation: Far Infrared Radiation (5μm to 20μm wavelength)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Persons with lower back pain Exclusion Criteria: None
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 |
| --- | --- |
| Other: 1<br> | Radiation: Far Infrared Radiation (5μm to 20μm wavelength)<br>* Far Infrared Radiation (5μm to 20μm wavelength)for 30 to 40 minutes per treatment session.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary end point is to determine the therapeutic effects of far infrared radiation on the Sciatic nerve. |  | 2 years and 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Far infrared treatment for other pain syndromes |  | 2 years and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Neuralgia, Sciatic, Sciatic Neuralgia, Sciatica, Bilateral, Lower back pain