linjc16/ctgov huggingface dataset:
Effects of Red Ginseng on Liver Function

Study Overview
=================
Brief Summary
-----------------
Korea Red Ginseng (KRG) has effect on liver function

Detailed Description
-----------------
Korea Red Ginseng (KRG) has been known as a natural product with anti-inflammatory effect in liver disease. Gut microbiota plays an important roles in the pathophysiology of nonalcoholic statohepatitis (NASH). We evaluated the effect of KRG on the pathophysiology of NASH

Official Title
-----------------
Effect of Korea Red Ginseng on Non-alcoholic Fatty Liver Disease

Conditions
-----------------
Liver Dysfunction

Intervention / Treatment
-----------------
* Dietary Supplement: Red ginseng


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: AST or ALT level > 50 IU/L Exclusion Criteria: Viral hepatitis Alcoholic hepatitis Autoimmune hepatitis Pancreatitis Hemochromatosis Wilson's disease Drug induced liver injury Cancer

Ages Eligible for Study
-----------------
Minimum Age: 37 Years
Maximum Age: 63 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: Ginseng trial<br>compare experimental group to controlled group | Dietary Supplement: Red ginseng<br>* Red ginseng tablet 120g<br>* Other names: Red ginseng tablet;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Liver enzyme | Decrease liver enzyme level | 1year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ginseng, Liver
Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the safety of the gynecological formulation in normal and usual usage condition of Dermacyd Delicata Pocket.

Official Title
-----------------
Monocentric Study, Phase III, for Safety Dermatological Evaluation: Acceptability With Gynecological Follow up - Dermacyd Delicata Pocket BR

Conditions
-----------------
Hygiene

Intervention / Treatment
-----------------
* Drug: Lactic acid (Dermacid)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Integral skin test in the region; Exclusion Criteria: Lactation or gestational risk or gestation; Use of Anti-inflammatory or immunosuppression drugs 1 month before the study; Topical medication use at the region to be treated; Cutaneous disease or active gynecological disease which may interfere in study results; Personal history of allergic disease at the area to be treated; Allergic or atopic history; The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: I<br> | Drug: Lactic acid (Dermacid)<br>* Liquid soup to be applied in the external genital area, in a small quantity, with abundantly rinse after use, during 21 days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events and their intensity and their association with the treatment. |  | 21 days |
The Auxiliary Effects of Fucoidan for Locally Advanced Rectal Cancer Patients

Study Overview
=================
Brief Summary
-----------------
This is a double-blind, randomized, placebo-controlled, parallel study. The main goal is to investigate the auxiliary effects of Fucoidan for the patients with locally advanced rectal cancer who receive neoadjuvant CCRT before surgery. The quality of life is our primary endpoint for this study. The study is an observational study.

Official Title
-----------------
A Double-blind, Randomized, Placebo-controlled, Parallel Study to Investigate the Auxiliary Effects of Fucoidan in Patients With Locally Advanced Rectal Cancer Who Receive Combined Radio-chemotherapy Before Surgery

Conditions
-----------------
To Observe Whether the Fucoidan Can Improve the Quality of Life of the Such Patients Receiving the Neoadjuvant CCRT

Intervention / Treatment
-----------------
* Behavioral: quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age was more/equal to 20 year-old and less/equal to 80 year-old Diagnosed as locally advanced rectal cancers by pathological biopsy and image study. ECOG performance status within 0 to 2 points Excepted life remaining at least 4 months Females with fertility are willing to use effective contraception during the period of study Willing to follow the test procedures and tracking procedures sign the inform consent form Exclusion Criteria: 1.Suffering from other primary malignant tumors 2.Females who are pregnant, planning to become pregnant, or breastfeeding 3.Participate in other interventional clinical trial within the first 30 days 4.Suffering from major mental illness such as mental retardation and mental disorders 5.Unable to understand and answer research questions (oral or written) 6.Abnormal laboratory data within 14 days before joining the study 7.Evidence that subject has a severe or uncontrolled disease -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: quality of life|To observe the difference of quality of life|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| auxiliary effects of Fucoidan | To evaluate the quality of life after unblind by 4th edit of FACT-C | 2 years |
Multicenter Randomized Prospective Trial Comparing Methotrexate Alone or in Combination With Adalimumab in Early Arthritis

Study Overview
=================
Brief Summary
-----------------
Evaluation of two treatment modalities in early potentially severe early arthritis ( Methotrexate alone or in combination with adalimumab)

Detailed Description
-----------------
Patients: early ( less than 6 months), active ( DAS>5.2),potentially severe ( Leiden score>6) Study design:12 months, prospective , randomized, open Study treatments: Methotrexate at a weekly dose of 0.3mg/kilo alone or in combination with adalimumab 40 mg every the other week Outcome measures: DAS over the 12 months

Official Title
-----------------
Methotrexate Alone Versus Methotrexate in Combination With Adalimumab in Early Arthritis

Conditions
-----------------
Rheumatoid Arthritis, Arthritis

Intervention / Treatment
-----------------
* Drug: Adalimumab
* Drug: Methotrexate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Early Active Potentially severe arthritis Exclusion Criteria: contra indication of methotrexate or anti TNF

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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Adalimumab|nan|
|Drug: Methotrexate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Activity Score |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| -Radiological score |  |  | 
| -Functional impairment ( HAQ) |  |  | 
| -Pain (VAS) |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
early arthritis, methotrexate, adalimumab
Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective Cesarean delivery using thromboelastography (TEG). We will compare coagulation data to assess potential coagulation changes associated with hemoglobin changes before and after surgery, and related to estimated blood loss.

Detailed Description
-----------------
The purpose of the study is to assess the coagulation changes that occur in patients undergoing elective Cesarean delivery using thromboelastography (TEG). TEG is a point-of-care device which measures the viscoelastic properties of clot formation. This device can provide rapid and detailed information about coagulation changes in the perioperative period. We will compare coagulation data collected from the study to assess potential coagulation changes associated with Hemoglobin changes before and after surgery, and related to estimated blood loss.

Official Title
-----------------
Thromboelastography to Assess Hemostatic Changes in Patients Undergoing Elective Cesarean Delivery.

Conditions
-----------------
Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All obstetric patients with singleton pregnancies admitted to the labor and delivery unit at Lucile Packard Hospital who undergo elective Cesarean delivery. We will select 100 healthy ASA 1 patients with singleton pregnancies who are scheduled for uncomplicated elective Cesarean delivery, with no anticipated risk of obstetric hemorrhage. Exclusion Criteria: Patients with underlying coagulation disorders. Patients with thrombocytopenia. Patients with pregnancy-induced hypertension, pre-eclampsia. Patients requiring the following medications prior to surgery: NSAIDS, aspirin, anticoagulants. Patients requiring non-elective Cesarean delivery. Patients with significant obstetric or medical disease. No patients <18 years of age will be recruited.
Sexes Eligible for Study
-----------------
Female

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 |
| --- | --- | --- |
| Estimated blood loss; Coagulation data (Thromboelastography, Laboratory) |  | pre and post cesarean delivery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hematologic indices |  |  |
Primary Prevention Habits for the Shoulder: Survey of the Sportsman's Entourage

Study Overview
=================
Brief Summary
-----------------
Purpose: To provide an update on the implementation of prevention among overhead athletes by their entourage. Materiel and method: This study will be conducted by the means of a questionnaire. The target population consisted of doctors, trainers, physical trainer and physiotherapist. The questionnaire will be validated by experts in each categorie and published on an online survey website

Official Title
-----------------
Primary Prevention Habits for the Shoulder: Survey of the Sportsman's Entourage

Conditions
-----------------
Primary Prevention, Shoulder, Questionnaire and Survey

Intervention / Treatment
-----------------
* Other: Primary prevention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Professions: physiotherapist, doctor, trainer or physical trainer Exclusion Criteria: Other professions

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Physiotherapist<br> | Other: Primary prevention<br>* The primary prevention that the 4 groups put in place for the upper limp athletes<br>|
| Doctor<br> | Other: Primary prevention<br>* The primary prevention that the 4 groups put in place for the upper limp athletes<br>|
| Physical trainer<br> | Other: Primary prevention<br>* The primary prevention that the 4 groups put in place for the upper limp athletes<br>|
| Trainer<br> | Other: Primary prevention<br>* The primary prevention that the 4 groups put in place for the upper limp athletes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary prevention of the shoulder |  | The questionnaire will last 15 minutes at most |
Safety of a Ready to Drink Supplement

Study Overview
=================
Brief Summary
-----------------
This study will examine a Ready to Drink (RTD) supplement.

Detailed Description
-----------------
This study will examine the short-term (7 days) characteristics of ingesting a Ready to Drink (RTD) supplement immediately prior to exercise on the blood, heart rate, blood pressure and self-reported side effects.

Official Title
-----------------
Short-Term Safety and Dose Effects of a Ready to Drink Pre-Workout Supplement

Conditions
-----------------
Dietary Supplements

Intervention / Treatment
-----------------
* Dietary Supplement: RTD
* Dietary Supplement: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants are apparently healthy and recreationally active males and females between the ages of 18 and 40 Exclusion Criteria: Participants are under 18 years old and above 40 years old Participants have a history of treatment for metabolic disease (i.e., diabetes), hypertension, hypotension, thyroid disease, arrhythmias and/or cardiovascular disease Participants currently use any prescription medication (birth control is allowed) Participants are pregnant or lactating females or plan to become pregnant within the next month Participants have a history of smoking Participants drink excessively (12 drinks per week or more) Participants have a recent history of creatine supplementation within 8 weeks of the start of supplementation

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: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: RTD<br>2.1 g. beta alanine, 1.3 g arginine nitrate, 200 mg caffeine, 65 mg niacin, 325 mcg folic acid, 45 mcg vitamin B12 | Dietary Supplement: RTD<br>* Ready to Drink Supplement<br>|
| Placebo Comparator: Placebo<br>dextrose and non-caloric flavoring | Dietary Supplement: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of ingesting an RTD immediately prior to exercise on the blood |  | 7 days | 
| The effects of ingesting an RTD immediately prior to exercise on heart rate |  | 7 days | 
| The effects of ingesting an RTD immediately prior to exercise on blood pressure |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The effects of ingesting an RTD immediately prior to exercise on self-reported side effects |  | 7 days |
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study

Study Overview
=================
Brief Summary
-----------------
The objective of this observational registry is to track the clinical progression of chronic limb-threatening ischemia (CLTI) and incidence of death, amputation, and revascularization attempts over a one-year period.

Official Title
-----------------
Natural Progression of High-Risk Chronic Limb-Threatening Ischemia: The CLariTI Study

Conditions
-----------------
Critical Limb Ischemia, Peripheral Artery Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject must be ≥18 years of age Subject is Rutherford 5 or 6 classification with hemodynamic evidence of severely diminished arterial inflow of a peripheral limb and: a) 2 revascularizations in the last 6 months that failed to resolve symptoms, OR b) An inadequate popliteal, tibial, or pedal revascularization target Subject is willing and able to sign the informed consent form and willing to participate in the phone follow-ups. Exclusion Criteria: Any significant concurrent psychological or social condition (e.g., no support person/network), which may significantly interfere with the subject's optimal participation in the study, in the opinion of the investigator. Subject is participating in the PROMISE II Clinical Trial.

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 |
| --- | --- | --- |
| Amputation Free Survival (AFS) | Defined as freedom from major (above ankle) amputation and death | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Minor Amputation | Number of patients with below-ankle amputation of the index limb | 12 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
CLI
The Experiences of Patients Living With Malignant Pleural Effusions

Study Overview
=================
Brief Summary
-----------------
Up to 20 patients with malignant pleural effusions will be interviewed about their experiences of having this condition and its management.

Official Title
-----------------
The Experiences of Patients Living With Malignant Pleural Effusions

Conditions
-----------------
Malignant Pleural Effusion

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults diagnosed with a malignant pleural effusion Has undergone either talc pleurodesis or IPC Have signed a consent form prior to entering the study Life expectancy > 6 weeks based on LENT guidelines (Low/Moderate risk group) - The LENT score calculation assigns 0 (<1500 IU/L) or 1 (>1500 IU/L) for pleural fluid LDH level; 0 to 3 points for matching ECOG performance scores (3 and 4 are combined); 0 (<9) or 1 (>9) for neutrophil-to-lymphocyte ratio; and 0 (lowest risk), 1 (moderate risk), or 3 (highest risk) for tumor type. Exclusion Criteria: Any patient who is unable to understand sufficient English to take part in the semi-structured interviews Weakness or fatigue sufficient so that the patient is unable to take part in the interviews

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 |
| --- | --- |
| Talc pleurodesis<br>Up to 10 patients who have had talc pleurodesis | |
| IPC<br>Up to 10 patients who have had indwelling pleural catheters (IPC) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Experiences of living with malignant pleural effusion and different pleural procedures | Qualitative interviews - Interviews will be recorded on a digital audio recorder and then downloaded on to a password protected computer. The interviews will then be sent for transcription using secure email and anonymised. We will perform thematic analysis on the interview data. This is a process to help explore the experiences of the subject as they describe it rather than looking at how they talk about the experience. Themes will be drawn from the data following coding. Common codes relating to a theme, for example pain, will be identified and examples of text used to demonstrate the theme extracted. This will ensure a wide variety of quotes across the interviews rather than focusing on one main or a subset of interviews. We will use an inductive approach whereby themes will emerge and not be developed in advance. Emerging codes will be checked by the supervisory team. There will be no numerical, quantitative data for analysis. | 4 weeks after IPC placement or talc pleurodesis |
Evaluation of Sublingual Microcirculation in Burn During Resuscitation

Study Overview
=================
Brief Summary
-----------------
The adequacy of fluid resuscitation will be monitored in burn patients using microcirculation. Microcirculation camera will be placed on the base of the tongue and at different four quadrants. • Microcirculation parameters at baseline and after 8h , 16h and 24h of fluid resuscitation will be recorded. Fluid resuscitation with lactated ringer according to Parkland formula (4 ml/kg/%TBSA) 50% given during the first 8 hours, with the remainder given during the following 16 hours, will be initiated to maintain a urinary output of 0.5ml/kg/hr.Norepinephrine infusion will be started in case of circulatory failure at a rate of 0.02mic/kg/min to maintain MAP of 65-70mmHg.

Official Title
-----------------
The Evaluation of Sublingual Microcirculation To Guide Fluid Resuscitation In Patients With Burn: Prospective Observational Study

Conditions
-----------------
Burn Shock

Intervention / Treatment
-----------------
* Device: Microcirculation cytocam


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age more than 18 years old Burn >20% TBSA Patients with burn admitted within the 1st 6 hours Exclusion Criteria: Age < 18 years old. Pregnant patients. Patients with severe renal insufficiency. Patients shocked due to other causes as sepsis, hypovolaemia or cardiogenic shock Patients with airway edema that preclude the measurement of sublingual microcirculation

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 |
| --- |
|Device: Microcirculation cytocam|Visualization of tongue microcirculation|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • Lactate level | mmol/L | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total vessel density | mm/mm2 | 24 hours |