linjc16/ctgov huggingface dataset:
Impact of a Chewable Plant Sterol Supplement on LDL-C in A Real-World Setting

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure the effectiveness of a twice daily plant sterol supplement, which is in a gummy format and packaged with health insights, in reducing LDL-C cholesterol in a real word setting.

Detailed Description
-----------------
While the safety and benefits of plant sterol supplements have been established and are incorporated into many lipid lowering guidelines, there have been few prior studies of plant sterol chewables in gummy format among real world subjects. In this study, we aim to measure the LDL-C reducing impact of regular plant sterol supplementation in a real world setting.

Official Title
-----------------
Impact of a Chewable Plant Sterol Supplement on LDL-C in A Real-World Setting

Conditions
-----------------
Hyperlipidemia

Intervention / Treatment
-----------------
* Dietary Supplement: Chewable plant sterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is an adult ≥18 years of age who continuously used the sponsor's product for at least 10 weeks prior to the Follow-on Lipid Test Baseline Lipid Test conducted within past 2 years If smoker, smoking status or frequency has not changed between two lipid test dates Subject understands the study procedures and signs forms documenting informed consent Exclusion Criteria: Subject was taking a prescription cholesterol-lowering medication or taking dietary supplements for cholesterol-lowering such as red yeast rice, niacin or omega-3 fatty acid supplements at the time of either lipid test Subject does not read English

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 |
| --- | --- |
| Plant sterol chewable<br> | Dietary Supplement: Chewable plant sterol<br>* Chewable plant sterol (gummy)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| % change in LDL-C from baseline |  | >10 weeks |
Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock

Study Overview
=================
Brief Summary
-----------------
This study aims to describe the ratio of the diameter of inferior vena cava to the common femoral vein measured by ultrasonography in critically ill patients with shock, and to evaluate the potential link between this ratio and the existence of intra-abdominal disease.

Detailed Description
-----------------
Among patients presenting with severe abdominal disease and shock, observations shown that the diameter of the common femoral vein was larger than the inferior vena cava. The hypothesis is that this observation could be secondary to a compression of the inferior vena cava related to an increased intra abdominal pressure.

Official Title
-----------------
Study of Ultrasonographic Cava Femoral Ratio in the Critically Ill Patient With Shock

Conditions
-----------------
Hemodynamic Instability

Intervention / Treatment
-----------------
* Procedure: Ultrasonography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult Need for ICU admission Need for vasopressor (epinephrine or norepinephrine) to obtain a mean arterial pressure at least of 65 mmHg Exclusion Criteria: Deep venous thrombosis related to inferior vena cava or common femoral veins Inability to measure inferior vena cava and common femoral vein diameters using ultrasonography

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

| Intervention/Treatment |
| --- |
|Procedure: Ultrasonography|At the time of ICU admission, among critically ill patients with shock, the investigators will measure the diameter of the common femoral vein and that of the inferior vena cava by ultrasonography.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ratio of the diameter of the inferior vena cava related to the common femoral vein |  | Up to 28 days after ICU admission | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
intra abdominal hypertension, shock, critically ill
A Clinical Trial Comparing Short-Term Efficacy and Safety of Exubera and Lantus

Study Overview
=================
Brief Summary
-----------------
To compare short-term efficacy and safety of Exubera vs Lantus in patients with type 2 diabetes mellitus

Official Title
-----------------
A 1 Month, Open-Label Inpatient, Randomized Cross-Over Trial Assessing The Impact Of Dry Powder Inhaled Insulin (Exubera) On 24-Hour Glycemic Control Compared To Insulin Glargine (Lantus) In Patients With Type 2 Diabetes Mellitus Who Are Poorly Controlled On A Combination Of Two Oral Agents

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

Intervention / Treatment
-----------------
* Drug: Inhaled Human Insulin (Exubera)
* Drug: Insulin Glargine (Lantus)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes mellitus Type 2 Exclusion Criteria: Severe Asthma, severe COPD Smoking

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Inhaled Human Insulin (Exubera)|nan|
|Drug: Insulin Glargine (Lantus)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Variability of blood glucose over a period of 72 hours |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insulin pharmacokinetics |  |  |
To Evaluate the Use of Radiomics to Classify Between Idiopathic Pulmonary Fibrosis and Interstitial Lung Disease

Study Overview
=================
Brief Summary
-----------------
To investigate the ability of machine learning models based on radiomic features extracted from thin-section CT images to differentiate IPF patients from non-IPF interstitial lung diseases.

Official Title
-----------------
Multi-center Validation of a Radiomics Based Model for the Diagnosis of Idiopathic Pulmonary Fibrosis

Conditions
-----------------
Interstitial Lung Disease, Idiopathic Pulmonary Fibrosis, Usual Interstitial Pneumonia

Intervention / Treatment
-----------------
* Diagnostic Test: radiomics


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: UIP with final diagnosis in biopsy ILDs with final diagnosis in biopsy Exclusion Criteria: patients with no biopsy confirmation

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 |
| --- | --- |
| Training dataset<br>No interventions | Diagnostic Test: radiomics<br>* The high-throughput extraction of large amounts of quantitative image features from medical images<br>|
| Validation dataset<br>No interventions | Diagnostic Test: radiomics<br>* The high-throughput extraction of large amounts of quantitative image features from medical images<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPF classifier | Model based on Radiomic that can differentiate IPF from ILDs. | Up to 30 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung, CT, UIP, IPF, ILDs
Study To Examine Effect Of CP-866,087 On Consumption And Craving Of Alcohol In Alcohol Dependent Subjects.

Study Overview
=================
Brief Summary
-----------------
Test the hypothesis that increasing doses of CP-866,087 will decrease the total number of drinks consumed during a 2 hour acute alcohol consumption assessment and to determine the safety and tolerability of multiple doses of CP-866,087 in alcohol dependent subjects compared to placebo.

Official Title
-----------------
Randomized, Placebo-Controlled Parallel Group Study Comparing Effect Of Three Doses Of CP-866,087 And Naltrexone On Acute Alcohol Consumption And Craving After Seven Days Of Treatment In Alcohol Dependent (DSM IV) Subjects Who Are Not Currently Seeking Treatment

Conditions
-----------------
Alcoholism

Intervention / Treatment
-----------------
* Drug: CP-866,087


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject meets the DSM-IV criterion for current alcohol dependence. Subject is currently not engaged in, and does not want, treatment for alcohol related problems. Exclusion Criteria: Subject meets criteria for current DSM-IV diagnosis for any other psychoactive substance abuse or dependence disorder, excluding nicotine and caffeine. Specialized inpatient or outpatient alcoholism or other addiction treatment (except nicotine) within the past 12 months.

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: CP-866,087|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The amount of alcohol consumed will be based on the total number of standardized drinks consumed during a two-hour laboratory-based self-administration procedure following 7 days of treatment with study medication. |  |  |
Formation of Health Professionals Through in Situ Simulation to Improve Performances During the Initial Step of Thrombectomy for Ischemic Strokes

Study Overview
=================
Brief Summary
-----------------
The thrombectomy is an emergency care provided as soon as possible to selected patients suffering from ischemic strokes. Many steps are necessary to prepare this specialized procedure of interventional neuroradiology, including installation and preparation of the patient for this act. This first and essential time required the intervention of many health professionals. The approach consists of a series of formation through in situ simulations for these health professionals, in order to improve and optimize this first step of the procedure (from the installation of the patient to the percutaneous punch by the neuroradiologist).

Official Title
-----------------
Optimization of Performances During Thrombectomy Through In Situ Simulation

Conditions
-----------------
Time, Benefit of in Situ Simulation for This Kind of Training, Installation of the Patient Until the Percutaneous

Intervention / Treatment
-----------------
* Other: In situ simulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: voluntary professionals

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Team of health professionals<br>Team of health professionals involved in thrombectomy (including specialized nurses in anesthesiology, anesthesiologists, neuroradiologist and technicians specialized in electro-radiology) will participate to in situ simulation. | Other: In situ simulation<br>* Team involved in thrombectomy procedures will be trained by in situ simulation. Simulation will reproduce the initial step of a thrombectomy procedure, i.e from from the installation of the patient to the percutaneous punch by the neuroradiologist. Simulation will be followed by a debriefing focused on the team performance. Three in situ simulation sessions will be realized by each team.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance of the team | Performance of the team will be scored using a technical and non-technical skill. | 12 months |
The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the general anesthesia immunosuppressive could effect hepatitis B Virus replication

Detailed Description
-----------------
The change of immune state can influence HBV replication or elimination, it has been reported that a certain degree of immunosuppression occured after general anesthesia. In this study we detect the cytotoxic T lymphocyte(CTL) count and activity, interferon-γ(IFN-γ) and HBV-DNA content form the HBV patient who will accept general anesthesia. Our purpose is to evaluate the influence of general anesthesia immunosuppressive on HBV replication. If the results show that HBV-DNA quantity increases, so the patients might be given anti-HBV drugs or immune enhancer; otherwise it is indicated the general anesthesia immunosuppressive don't influence HBV replication.

Official Title
-----------------
The Effect of General Anesthesia Immunosuppressive on Hepatitis B Virus Replication

Conditions
-----------------
HBV Infection

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: American Society of Anesthesiologists（ASA） Ⅰ - Ⅱ; ability to compliance the research plan; volunteered and signed for the study ; HBsAg positive, no serious system disease (heart: New York Heart Association（NYHA） class Ⅰ - Ⅱ, lung: vital capacity（VC）% or maximal voluntary ventilation（MVV）%>71, forced expiratory volume at one second（FEV1.0）%>61, arterial oxygen saturation（SaO2）%>94, arterial partial pressure of oxygen（PaO2）>75 mmHg, arterial carbondioxide partial pressure（PaCO2）<45mmHg, liver:child-pugh class A - B and kidney: chronic kidney disease（CKD）stage 1-3); receive under general anesthesia (including gynecology, orthopedics,general surgery and urology department). Exclusion Criteria: ASA>Ⅱ; tumor patients can't collaborate;

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| A<br>intravenous inhalational anesthesia | |
| B<br>intravenous anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HBV-DNA | collect blood samples 4 times with in the first 5 days after surgery: the first time：before initiation of anesthesia; the second time：the first day after surgery; the third time：the third day after surgery; the forth time：the fifth day after surgery. And outcome measure will be assessed with in 3 months when all the samples collected, and will be presented with in 2 months when outcome measure assessed . | with in the first 5 days after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Need general anesthesia
Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men

Study Overview
=================
Brief Summary
-----------------
This study aims to compare the effects of 8 months of diet modification, with or without exercise, on weight loss, sexual, urinary and endothelial function, systemic inflammation and quality of life in obese men.

Official Title
-----------------
Comparing Effects of Diet, With or Without Exercise, on Sexual, Urinary and Endothelial Function, Inflammatory Profile and Quality of Life in Obese Men

Conditions
-----------------
Sexual Dysfunction, Endothelial Dysfunction, Quality of Life, Inflammation

Intervention / Treatment
-----------------
* Behavioral: weight loss counselling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male, aged 30-65 years Body Mass Index (BMI) >/= 27.5 kg/m2 Waist circumference (WC) >/= 90 cm Exclusion Criteria: pituitary disease or cranial radiotherapy previous or current androgen replacement or deprivation therapy current treatment for sexual problems or LUTS glomerular filtration rate < 60 ml/min liver disease alcohol intake exceeding 500 g/week in the previous 12 months use of opiates, glucocorticoids, recreational drugs or phosphodiesterase inhibitors

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: diet modification<br>counselling on caloric restriction and healthy eating | Behavioral: weight loss counselling<br>* Diet counselling with or without sports trainers, over 8 months<br>|
| Experimental: weight management program<br>dietician and sports trainer, physician counselling on weight loss | Behavioral: weight loss counselling<br>* Diet counselling with or without sports trainers, over 8 months<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| erectile function | IIEF-5 score | 8 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| lower urinary tract symptoms | IPSS score | 8 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, men, sexual function, urinary tract symptoms, endothelial function, inflammation, quality of life
Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the effect of Moringa oleifera leaf capsule in increasing breast milk volume

Official Title
-----------------
Effect of Moringa Oleifera Capsule in Increasing Breast Milk Volume in Early Postpartum Patients: A Double Blind Randomized Controlled Trial

Conditions
-----------------
Postpartum Women

Intervention / Treatment
-----------------
* Drug: Moringa oleifera leaf
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postpartum women Exclusion Criteria: Postpartum women with contraindication for breast feeding such as HIV, untreated tuberculosis, on chemotherapeutic drugs, on radioactive drugs, substance abuse. Postpartum women with unstable conditions such as postpartum hemorrhage.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Moringa oleifera leaf<br>Participants received Moringa oleifera leaf 450 mg capsule orally twice daily for 3 days. | Drug: Moringa oleifera leaf<br>* 450 mg capsule<br>|
| Placebo Comparator: Placebo<br>Participants received placebo capsule orally twice daily for 3 days. | Drug: Placebo<br>* placebo capsule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Breast milk volume at postpartum day 3 | Breast milk volume measuring by weighting the infant fully clothed before and after each feeding with an electronic weigh scale for the period of 24 hours (at postpartum day 3). The sum of weight difference in gram was then converted to breast milk volume in milliliter (1 g = 1 mL). | day 3 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| percentage of good satisfaction | satisfaction evaluated by 5 scales | 3 days | 
| quality of life scores | Quality of life measuring by Thai version of WHO-QOL questionaire | 3 days | 
| side effects | percentage of side effects such as headache, nausea/vomiting | 3 days | 
| Compliance | percentage of complete drug use | 3 days |