linjc16/ctgov huggingface dataset:
Helmet Ventilation During Self-Paced Walking Test

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.

Detailed Description
-----------------
Chronic obstructive pulmonary disease (COPD) is characterized by persistent airflow limitation with chronic inflammation of the respiratory system. Symptoms of COPD may contribute to activity restriction, deconditioning and exercise intolerance. Non-invasive positive pressure ventilation (NIPPV) has been shown to improve exercise intolerance and health-related quality of life in patients with severe COPD. Helmet ventilation (HV) is a new option for NIPPV to alternative to nasal or face mask. A study which published on JAMA demonstrated the feasibility and benefits of HV. The aim of this study is to investigate the use helmet ventilation (HV) in walking test and analysis of effect patients with COPD.

Official Title
-----------------
Helmet Ventilation During Self-Paced Walking Test With Chronic Obstructive Pulmonary Disease

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

Intervention / Treatment
-----------------
* Device: Helmet vetilation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patents with COPD who confirm by pulmonary function test Exclusion Criteria: COPD AE within 3 months Diagnosed neuromuscular disease Unable to perform 6-MWT

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HV<br>6MWT with helmet ventilation | Device: Helmet vetilation<br>* We will apply non-invasive positive pressure ventilation via a helmet as interface<br>|
| No Intervention: Control<br>6MWT alone according to ATS guideline | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 6WMD | Walking distance of six minute walking test | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Heart rate | Heart rate of six minute walking test | 2 days | 
| Respiratory rate | Respiratory rate of six minute walking test | 2 days | 
| modified Borg dyspnea scale | A self report level of dyspnea score ranging from 0 to 10, 0 represent no dyspnea and 10 represents the worse | 2 days |
Intermountain Risk Score and Trauma

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that a risk score composed of age, sex, and the components of commonly ordered laboratory panels will be predictive of mortality in trauma patients, and will help improve clinicians' ability to make more accurate mortality predictions at the time of admission.

Official Title
-----------------
The Intermountain Risk Score's Association With Mortality Prediction in Trauma Patients

Conditions
-----------------
Trauma, Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient presents to Intermountain Medical Center as a Level I or Level II trauma activation. Age ≥18 Exclusion Criteria: Patients who are not admitted to the hospital Patients who expire in the Emergency Department Patients who are discharged to home from the Emergency Department Patients who do not have a complete blood count and basic metabolic profile drawn in the Emergency Department as part of routine clinical care. Patients who enter the hospital as trauma consults. These patients have traumatic injuries, and are often admitted to the trauma service, but the severity of their trauma is not thought to warrant trauma team activation.

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 |
| --- | --- |
| Intermountain Risk Score known<br> | |
| Intermountain Risk Score Unknown<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality | To determine whether the Intermountain Risk Score accurately predicts 30 day mortality and one year mortality in trauma patients. | 30 days | 
| all cause mortality | measure the ability of the Intermountain Risk Score to predict all cause mortality at one year after the traumatic event | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| experienced clinicians mortality prediction | compare the IMRS to experienced clinicians' ability to predict mortality at 30 days | 30 days | 
| Experienced Clinicians' mortality prediction | compare the IMRS to experienced clinicians' ability to predict mortality at 1 year | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trauma, Scoring Systems, Intermountain Risk Score
Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that analysis of blood pressure will allow doctors to predict whether or not blood flow from the heart (cardiac output) increases after intravenous fluids are given.

Detailed Description
-----------------
Total to expected enrollment: 70

Official Title
-----------------
Response of Pulse Pressure Variation in PA Catheter Tracing to IV Fluid Bolus in the ICU

Conditions
-----------------
Hypovolemia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: TCV-PO post-operative patients with PA catheters Must be 18 years of age and older Exclusion Criteria: History of Pulmonary Hypertension

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients having cardiac surgery<br>Patients having cardiac surgery who have a pulmonary artery catheter will be eligible for inclusion in this study | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in cardiac output | Change in cardiac output after intravenous fluids are given | First five hours after surgery |
Differences in Pain Processing Between Men and Women

Study Overview
=================
Brief Summary
-----------------
Many chronic pain conditions show clear differences between between men and women, such as reported pain intensities or treatment effects, with chronic pain conditions being generally more frequent in women. Yet, the underlying mechanisms causing these differences are poorly understood. Central sensitization (CS) is considered one important mechanism in pain patients which differs between female and male patients. The central hypothesis is that already in the healthy population CS processes are more pronounced in women than in men.

Official Title
-----------------
Differences in Sensitization Between Men and Women After Cutaneous Thermal Stimuli

Conditions
-----------------
Central Sensitisation

Intervention / Treatment
-----------------
* Other: Cutaneous thermal stimuli


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: good general health able to give informed consent Exclusion Criteria: pain complaints for more than two consecutive days over the past three months any major medical or psychiatric condition (e.g. heart disease, major depressive disorder) any chronic pain condition inability to follow study instructions consumption of stimulants, drugs, or analgesics within the past 24 hours scar tissue or generally reduced sensitivity in the designated testing site areas

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Arm<br> | Other: Cutaneous thermal stimuli<br>* Application of thermal stimuli of different intensities to the skin<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in spatial extent of mechanical hypersensitivity after intervention w.r.t. baseline | Mapping of hypersensitivity in cm2 of sensitized skin area using two quantitative sensory testing tools (256mN von Frey filament and 200-400mN brush) before and after intervention | 10-20 minutes before intervention (baseline) and 20-30 minutes after intervention | 
| Changes to the nociceptive withdrawal reflex (NWR) after intervention w.r.t. baseline | Repetitive suprathreshold elicitation of the NWR to monitor its characteristics (such as magnitude and number of responses) before and after intervention | 5-10 minutes before intervention (baseline) and 30-35 minutes after intervention | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
central sensitisation, central sensitization, nociception, withdrawal reflex, heat pain, secondary hyperalgesia
Evaluation of Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period

Study Overview
=================
Brief Summary
-----------------
This study is conducted in the United States of America (USA). The aim of this study is to assess longitudinal variation of immune biomarkers in subjects with type 1 diabetes (T1D), type 2 diabetes (T2D) and healthy, non-diabetic subjects over a one year period.

Official Title
-----------------
An Observational Study Evaluating Biomarker Expression in Diabetic and Healthy Subjects Over a One Year Period

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

Intervention / Treatment
-----------------
* Other: No treatment given


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: T1D Male or female subjects diagnosed within the last 3 years and with good general health based on medical history Age above or equal to 14 years and below or equal to 40 years Body weight above 45 kg T2D Male or female subjects diagnosed within the last 15 years with good general health based on medical history HbA1c between 6.5% and 10% Body mass index (BMI) below 45 kg/m^2 Age above or equal to 18 and below 65 years On insulin treatment HS Male or female subjects with good general heath based on medical history Age above or equal to 18 years and below or equal to 40 years Exclusion Criteria: Any chronic disorder (besides T1D or T2D) or severe disease which, in the opinion of the investigator, might jeopardize subject's safety or compliance with the protocol Female of child-bearing potential who is pregnant, breast-feeding, or intends to become pregnant

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 40 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 |
| --- | --- |
| All participants<br> | Other: No treatment given<br>* The participants will not receive any treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in CD8 (cluster of differentiation) +T-cell specificity profiling |  | Over a one year period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variation in CD4 +T-cell specificity profiling |  | Over a one year period | 
| Change in stimulated C-peptide |  | Baseline, one year | 
| Fluctuation in islet autoantibodies titers |  | Over a one year period | 
| Variation in HbA1c (glycosylated haemoglobin) |  | Over a one year period |
Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With ALS

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety of oral edaravone at a dose of 105 mg administered once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. This study will be continued until the earlier date when oral edaravone is commercially available at each site in Japan or August 2023.

Official Title
-----------------
Multicenter, Open-label Extension Study Following the Studies MT-1186-A03 or A04 to Evaluate the Safety of Oral Edaravone in Subjects With Amyotrophic Lateral Sclerosis (ALS)

Conditions
-----------------
ALS

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must provide a 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 complete Week 96 of Study MT-1186-A03 or Week 48 of Study MT-1186-A04 and have been compliant with study drug (80-120%). Exclusion Criteria: Subjects of childbearing potential unwilling to use a highly effective method of contraception from the 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 Week 96 of the A03 study or at Week 48 of the A04 study. Subjects who are not eligible to continue in the study, as judged by the Investigator.

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: MT-1186 orally<br>Subjects receive the edaravone oral suspension orally once daily for 10 days out of a 14-day period, followed by a 14-day drug-free period. | Drug: MT-1186<br>* Suspension<br>* Other names: Edaravone;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with AEs and adverse drug reactions |  | up to 10 months or 31/Aug/2023 |
A Study of Repeat-Dose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the single dose pharmacokinetics (PK) of subcutaneous (SC) darbepoetin alfa in subjects with congestive heart failure (CHF) and anemia.

Official Title
-----------------
A Study to Assess the Pharmacokinetics and Pharmacodynamics of Repeat-Sose Subcutaneous Darbepoetin Alfa in Subjects With Congestive Heart Failure and Anemia, and a Single Dose in Healthy Age- and Sex-Matched Control Subjects

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

Intervention / Treatment
-----------------
* Drug: darbepoetin alfa


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Symptomatic CHF despite optimized therapy for at least the previous 3 months (treatment included a diuretic, angiotensin converting enzyme [ACE] inhibitor, and/or an A2 antagonist, unless not tolerated) - Hemoglobin greater than or equal to 12.5 g/dL at the time of screening

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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: darbepoetin alfa|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic profiling of Aranesp® in HF pts |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic responses (hgb) following Aranesp® administration in HF patients |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Heart Failure
Clinical and Molecular Characterization of Familial Microsatellite Stable Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Two major genetic pathways leading to colorectal carcinoma can well be distinguished; the 'suppressor pathway', which is characterized by inactivation of tumor-suppressor genes and the 'mutator pathway', which is characterized by microsatellite instability. The purpose of this study is to explore a third putative pathway; microsatellite and chromosome stable colorectal cancer where an alternative cancer-causative mechanism might play a role.

Detailed Description
-----------------
Patients with familial colorectal cancer will be characterized with respect to family history, medical history and demographic characteristics. The histopathology of the tumors will be reviewed. Tumor specimens will be analysed on molecular defects.

Conditions
-----------------
Colorectal Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - Colorectal cancer before the age of 51 years Microsatellite stable tumor Exclusion Criteria: -

Ages Eligible for Study
-----------------
Maximum Age: 51 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
-----------------
Hereditary colorectal cancer, Microsatellite instability, Chromosomal instability
Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer.

Study Overview
=================
Brief Summary
-----------------
This is a prospective, clinical study. This study is to collect and analyze data of radiomics of primary site or metastasis of colorectal cancer aiming to precisizing preoperative diagnosis and long-term prognsis evaluation.

Official Title
-----------------
Application of Radiomics in Precise Preoperative Diagnosis and Prognsis Evaluation of Colorectal Cancer: a Prospective, Clinical Study

Conditions
-----------------
Colorectal Cancer Stage I-IV

Intervention / Treatment
-----------------
* Diagnostic Test: CT or MRI based Radiomics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with pathologically confirmed colorectal cancer Male or female aged 18-75 years old on the day of signing informed consent. Patients who received imageological examination of primary or metastasis Patients who received surgical resection of primary or metastasis Patients must have a performance status of ≤1 on the ECOG Performance Scale. Colorectal cancer is the only malignant tumor Written informed consent must be obtained from patient or patient's legal representative and ability for patient to comply with the requirements of the study Exclusion Criteria: Patients received adjuvant treatment prior to imageological examination Tis stage patients Paitents who diagnosed with malignant disease within 5 years. Patients with a history or current evidence of any condition or abnormality that might confound the results of the study, interfere with the patient's participation for the full duration of the study, or is not in the best interest of the patient to participate, in the opinion of the Investigator.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with pathologically diagnosed colorectal cancer<br>Patients with pathologically diagnosed colorectal cancer | Diagnostic Test: CT or MRI based Radiomics<br>* Radiomic features were extracted from enhanced CT or MRI of colorectal cancer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity | The sensitivity of radiomics in predicting regional or distant synchronous colorectal metastasis | 2 years |
Hysterosalpingography and Hysteroscopy in ICSI

Study Overview
=================
Brief Summary
-----------------
unexplained infertility is a rising problem in clinical practice

Detailed Description
-----------------
Assessment of uterine cavity is very important before ICSI

Official Title
-----------------
Hysterosalpingography and Hysteroscopy in Intracytoplasmic Sperm Injection

Conditions
-----------------
Infertility

Intervention / Treatment
-----------------
* Other: occlusion of tubes
* Other: non occlusion of tubes


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with infertility Exclusion Criteria: women with medical disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 42 Years

Sexes Eligible for Study
-----------------
Female

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: tubal occlusion<br>occlusion of tubes | Other: occlusion of tubes<br>* to occlude the fallopian tubes<br>|
| Sham Comparator: non occlusion of tube<br>non occlusion of tubes | Other: non occlusion of tubes<br>* not to occlude the tubes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the number of women who will become pregnant | number of women who will have positive pregnancy test | 3 months |