linjc16/ctgov huggingface dataset:
Study of NI-071 in Comparison With Remicade in Patients With Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the safety of NI-071 with Remicade® (infliximab) in patients with Rheumatoid Arthritis inadequately treated with Methotrexate.

Official Title
-----------------
A Randomized, Double-Blind, Repeated Dose, Active Control Drug, Parallel-group and Single-center Phase I Study of the Safety of Intravenous Administration of NI-071 in Comparison With Remicade® in Japanese Patients With Rheumatoid Arthritis Inadequately Treated With Methotrexate

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

Intervention / Treatment
-----------------
* Biological: Infliximab
* Biological: Infliximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of Rheumatoid Arthritis (RA) as defined by the 1987 revised American College of Rheumatology (ACR) criteria with ACR Functional Classification class I-III and disease duration of no less than 3 months Patients must receive a minimum of 3 months treatment with methotrexate (MTX) (≥ 6 mg/week) prior to the Screening Visit. Patients must be on a stable dose of MTX (6 mg 16 mg mg/week) for a minimum of 4 weeks prior to the Screening Visit Exclusion Criteria: History of following diseases Other Connective tissue disorders with joint symptom which may interfere the efficacy assessment Chlonic or recurrent infectious disease（bronchial ectasia, sinus inflammation etc.） Severe infectious disease（hepatitis, pneumonia、sepsis） History of demyelinating disease or multiple sclerosis Congestive heart failure lymphoproliferative disorder or myelodysplastic syndrome History of malignancy Interstitial lung disease Patients with active or latent tuberculosis or history of tuberculosis

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NI-071<br> | Biological: Infliximab<br>* 100mg/vial<br>|
| Active Comparator: Remicade<br> | Biological: Infliximab<br>* 100mg/vial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety : Incidence of Adverse Events |  | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| PK : Area under the serum concentration versus time curve(AUC) |  | 14 weeks | 
| Efficacy : ACR core-set |  | 14 weeks |
Vasopressor SAT Study

Study Overview
=================
Brief Summary
-----------------
To assess the impact of daily awakening from sedation on the amount of vasoactive medication required in the ICU. The hypothesis of this proposal is that the amount of vasoactive drug required to maintain an adequate mean arterial blood pressure will be reduced during a daily awakening from sedation.

Detailed Description
-----------------
This observational study will compare mean arterial pressure and vasoactive drug dose recorded at two time points: prior to awakening from sedation during the awakening from sedation trial The vasoactive infusion will be titrated to a mean arterial pressure as determined by the medical team prior to study enrollment. Each enrolled patient will have measurements taken only on the first day of enrollment. Enrolled subjects will also have a delirium assessment using the CAM-ICU tool before the awakening from sedation trial and during the awakening from sedation trial.

Official Title
-----------------
An Assessment of Vasoactive Medication Dose in Mechanically Ventilated Patients Undergoing Daily Sedation Awakening Trial (SAT)

Conditions
-----------------
Low Blood Pressure, Delirium, Critical Illness

Intervention / Treatment
-----------------
* Other: sedation awakening trial


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: requiring Mechanical ventilation through an endotracheal tube with infusion of sedative or analgesic agent for comfort requiring vasoactive drug via central venous catheter for the treatment of shock Exclusion Criteria: patients receiving Dexmedetomidine as sedative

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 |
| --- | --- |
| Mechanical Ventilation (MV) with vasoactive infusions<br>adult ICU patients who are mechanically ventilated with sedative infusion and/or analgesic infusion and also requiring vasoactive drug infusions for the treatment of shock. Patients will be excluded if receiving dexmedetomidine as sedative. | Other: sedation awakening trial<br>* vital signs and delirium assessment (CAM-ICU) at baseline then following routine sedation awakening trial. Patient will thus serve as their own control for these interventions<br>* Other names: SAT;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in vasoactive drug dose | mcg/kg/min baseline dose and nadir dose | baseline thru study completion on average < 4 hrs | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| change in mean arterial blood pressure | mm Hg | baseline thru study completion on average <4 hrs | 
| change in prevalence of ICU delirium | CAM ICU score | baseline thru study completion on average <4hrs |
Endoscopy for Post-operative Fistula

Study Overview
=================
Brief Summary
-----------------
Endoscopic treatment of early post-operative fistula in patients with underlying esophageal or gastric cancer has now become the standard of care. However, data regarding the yield of this type of treatment is lacking. This study aims to evaluate endoscopic management of this post-operative complication. The main outcome of this prospective observational study conducted in tertiary centers in France is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment.

Official Title
-----------------
Endoscopic Treatment of Post-operative Fistula of the Upper Digestive Tract

Conditions
-----------------
Post-operative Fistula

Intervention / Treatment
-----------------
* Procedure: Endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient over 18 years Early fistula (< 30 days) Post surgery: Lewis Santy, Akiyama, partial or total gastrectomy Indication of endoscopic management: metal stents and/or plastic stents Exclusion Criteria: Pregnancy Incapable of decision making and informed consent Life expectancy < 1 month General anesthesia contra-indication Late fistula (> 30 days) Prior endoscopic treatment Wall ischemia Duodenum or small bowel fistula Post bariatric surgery

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: Endoscopy|Endoscopic treatment will consist in placement of a metal stent in a patient with early fistula (< 15 days) and/or a large fistula orifice, and no abscess, or double pigtail plastic stents if the fistula is older than 15 days and the orifice is small.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| fistula healing | The main outcome is fistula healing defined as the absence of collection on CT scan (with opacification) in a patient on PO diet, 3 months after the end of the endoscopic treatment. | 3 months after the end of the endoscopic | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fistula, Upper digestive tract, Cancer
D-chiro-inositol and Endometrial Thickness

Study Overview
=================
Brief Summary
-----------------
Investigation of the effects of D-chiro-inositol supplementation in women with altered endometrial thickness.

Official Title
-----------------
The Effects of D-chiro-inositol in Endometrial Thickness

Conditions
-----------------
Endometrial Diseases

Intervention / Treatment
-----------------
* Dietary Supplement: DCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - altered endometrial thickness Exclusion Criteria: patients with cancer patients under hormonal treatments (progestogens and/or estrogens) patients supplemented with inositols

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: DCI<br>Oral supplementation with D-chiro-inositol once a day | Dietary Supplement: DCI<br>* Oral supplementation with D-chiro-inositol once daily<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endometrial thickness | Change in endometrial thickness by ultrasound measurement from baseline to three months | Two time points: baseline and after three months |
An Evaluation of Kinerase Pro+Therapy Regimen Vs. Kinerase Vs. Control for the Treatment of Skin Aging

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of the Kinerase Pro+Therapy regimen versus a single Kinerase product vs. control for the treatment of the signs of skin aging.

Conditions
-----------------
Skin Aging

Intervention / Treatment
-----------------
* Drug: Kinerase Pro+Therapy Line day repair, serum, night repair
* Drug: Kinerase Pro+Therapy Line Ultra rich day repair
* Drug: LubriDerm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female patients 35-55 years of age with at least moderate signs of facial aging Written informed consent Likely to complete all study visits and follow study protocol Exclusion Criteria: Any dermatological or medical condition which would make patient participation unsafe or interfere with study outcomes or measurements Known hypersensitivity to any study product or their components Recent (within 4 weeks of baseline) surgical treatment to face (including IPL and other laser procedures) Prior use of anti-aging treatments for 30 days prior to study entry (physician dispensed or prescribed treatments) Planned facial procedures during the study (microdermabrasion, facials, etc) o Botox and fillers cannot be used during the trial or for 3 months prior to study entry Recent (within 60 days) or concurrent participation in another clinical trial Concomitant topical or systemic therapy that my interfere with study measurements or outcomes Use of any other topical photoaging/antiaging therapies during the study, other than the prescribed study regimens Patients who are habitual tanners (outdoors or with tanning beds) who plan on tanning during the study Wearing of cosmetics during study visits

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 55 Years

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

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

Design Details

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Kinerase Pro+Therapy Line day repair, serum, night repair|nan|
|Drug: Kinerase Pro+Therapy Line Ultra rich day repair|nan|
|Drug: LubriDerm|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Phase 1 Study of Anti-glycation Agent GLY-230 in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
To test the safety of GLY-230 and to evaluate how long drug stays in blood after taking it by mouth.

Official Title
-----------------
Phase 1 Study of Anti-glycation Agent GLY-230

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

Intervention / Treatment
-----------------
* Drug: GLY-230
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men age 18-55 Negative drug screen Normal EKG, clinical chemistries, CBC, urinalysis, and Give written informed consent Exclusion Criteria: Active concomitant serious medical or surgical disease, Hepatic or renal laboratory values above reference range, ise of other experimental drug within previous 30 days

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 50 mg<br> | Drug: GLY-230<br> <br> |
| Experimental: 100 mg<br> | Drug: GLY-230<br> <br> |
| Experimental: 250 mg<br> | Drug: GLY-230<br> <br> |
| Experimental: 500 mg<br> | Drug: GLY-230<br> <br> |
| Experimental: 750 mg<br> | Drug: GLY-230<br> <br> |
| Experimental: 1000 mg<br> | Drug: GLY-230<br> <br> |
| Placebo Comparator: Placebo<br> | Other: Placebo<br>* No drug administered<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A Dose-Ranging Study to Evaluate the Phamacokinetics and Safety of Six Single-Dose Levels of GLY-230 in Healthy Subjects |  | October, 2005 to October, 2006 |
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

Study Overview
=================
Brief Summary
-----------------
Randomisation between postoperative administration of an ACE-inhibitor or not.

Detailed Description
-----------------
Children that are undergoing elective surgery for the creation of a Fontan circulation will be randomised to postoperative administration of an ACE-inhibitor or not. Determination of aldosteron, renine and ADH in serum preoperatively and 1h, 12h and 5 days postoperatively.

Official Title
-----------------
Pathophysiological Mechanisms of Hepatopulmonary Influence in the Fontan Circulation

Conditions
-----------------
Children With a Univentricular Heart Undergoing Surgery for Creation of a Fontan Circulation

Intervention / Treatment
-----------------
* Drug: Administration of an ACE-inhibitor or not


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All consecutive children with a univentricular heart disease undergoing elective surgery for creation of a Fontan circulation Parents have agreed with the study after informed consent Exclusion Criteria: Urgent / Emergent surgery Preoperative use of an ACE-inhibitor

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Administration of an ACE-inhibitor or not|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Duration of the pleural drainage in the first two postoperative weeks |  |  |
Study Comparing One Versus Two Cortisone Injections for Trigger Finger

Study Overview
=================
Brief Summary
-----------------
Trigger finger, also known as stenosing tenosynovitis, is a painful condition that can cause discomfort and disability. Many physicians choose to locally inject cortisone into the infected finger although there is no current consensus as to how many injections are needed to achieve maximum relief. This study will be a prospective, randomized study to compare one versus two injections for the treatment of trigger finger.

Official Title
-----------------
A Prospective, Randomized Study Comparing One vs. Two Cortisone Injections for Trigger Finger

Conditions
-----------------
Stenosing Tenosynovitis, Trigger Finger

Intervention / Treatment
-----------------
* Drug: One cortisone injection
* Drug: Two cortisone Injections


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is greater than 18 years of age, presenting with stenosing tenosynovitis. Subject is willing and able to provide informed consent. Exclusion Criteria: Patients who have previously undergone surgery for the treatment of trigger finger.

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: Parallel Assignment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: One injection<br> | Drug: One cortisone injection<br>* Patients in this arm will receive one cortisone injection for the treatment of his/her symptoms<br>|
| Active Comparator: Two Injections<br> | Drug: Two cortisone Injections<br>* Subjects randomized to this treatment will receive two cortisone injections, 4-6 weeks apart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if there is a difference in the incidence of pain, stiffness, clicking or locking at 6 months following final injection |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate treatment response among diabetic patients |  |  | 
| To evaluate treatment response between thumbs and fingers |  |  | 
| To evaluate treatment response between nodular versus diffuse tenosynovitis |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Trigger Finger, Trigger Thumb
Respiratory Emissions in Healthy Participants

Study Overview
=================
Brief Summary
-----------------
This is an randomised cross over trial in healthy participants measuring respiratory emissions during different respiratory activities.

Official Title
-----------------
Respiratory Emissions in Healthy Participants

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Exertional respiratory activities


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults, over the age of 18 and able to give informed consent Symptom free from any respiratory illness in the last 48 hours Exclusion Criteria: Pregnant (where the participant feels that their pregnancy will make participation uncomfortable) Inability to give consent Current respiratory disease. Participants with well controlled asthma will be included (defined as asthma that the participant self-rates their asthma as being under control and that does not limit exercise, work)

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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Respiratory Activity 1<br> | Behavioral: Exertional respiratory activities<br>* participants will perform a series of exertional respiratory activities<br>|
| Experimental: Respiratory Activity 2<br> | Behavioral: Exertional respiratory activities<br>* participants will perform a series of exertional respiratory activities<br>|
| Experimental: Respiratory Activity 3<br> | Behavioral: Exertional respiratory activities<br>* participants will perform a series of exertional respiratory activities<br>|
| Experimental: Respiratory Activity 4<br> | Behavioral: Exertional respiratory activities<br>* participants will perform a series of exertional respiratory activities<br>|
| Experimental: Respiratory Activity 5<br> | Behavioral: Exertional respiratory activities<br>* participants will perform a series of exertional respiratory activities<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Count of total number of respiratory particles emitted during respiratory activities in the range of 0.3 to 25 microns | Particles emitted will be counted using two different optical particle counters | Emission of particles will be collected and analysed for 2 minutes during each experimental condition |