linjc16/ctgov huggingface dataset:
A Study to Compare Subject Comfort During and After Injections With the Study Products and the Safety of the Non-FDA Approved Product for the Correction of Nasolabial Folds (NLFs)

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to compare subject comfort during and after injection with NADGL and Captique® Injectable Gel, in the nasolabial folds. Captique® is an FDA-approved product without lidocaine and is manufactured by Genzyme Biosurgery (Ridgefield, NJ). NADGL is a new product (not FDA approved) with lidocaine and is also manufactured by Genzyme Biosurgery. We do not know which of these treatments results in less pain during and after injection. The safety of NADGL is also being studied.

Detailed Description
-----------------
45 subjects are planned; a portion of these subjects will have skin of color

Official Title
-----------------
A Single-Blind, Randomized, Single-Center Evaluation of Procedural and Post Procedural Pain Experienced With Injections of NADG With Lidocaine Injectable Gel as Compared to Captique® Injectable Gel in Subjects Undergoing Cutaneous Correction of Nasolabial Folds

Conditions
-----------------
Facial Wrinkles

Intervention / Treatment
-----------------
* Device: NADGL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: bilateral nasolabial folds with severity score of 3 or 4 on the 6 point scale. Exclusion Criteria: pregnant/lactating women subjects who have an allergy to lidocaine or other amide-type anesthetics

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: NADGL|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the pain experienced during and after the injection procedure for NADGL as compared to Captique® Injectable Gel in subjects undergoing cutaneous correction of nasolabial folds (NLFs). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate the safety of NADGL. |  |  |
Correlation Between Pi Max and Diaphragm Maximum Inspiratory Excursion Detected With Ultrasound During Weaning

Study Overview
=================
Brief Summary
-----------------
This study evaluates the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound during the weaning from invasive mechanical ventilation.

Official Title
-----------------
Correlation Between Pi Max and Diaphragm Maximum Inspiratory Excursion Detected With Ultrasound During Weaning

Conditions
-----------------
Weaning, Diaphragm Ultrasound, Maximum Inspiratory Pressure

Intervention / Treatment
-----------------
* Diagnostic Test: diaphragm ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years. Invasive Mechanical Ventilation > 24 hours. Readiness for weaning (following clinician decision made according to recent guidelines). Exclusion Criteria: Impossibility to perform an echography.

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 |
| --- | --- |
| case group<br>diaphragm ultrasounds during weaning and Pimax measures | Diagnostic Test: diaphragm ultrasound<br>* For each patient intubated and ventilated in our ICU we will performed diaphragm ultrasound during the weaning process. We will performed the measurement of diaphragmatic maximum excursion during a maximal inspiration using an abdominal standard preset with M-mode, with the so called anatomical M-mode. We will put the probe in the right subcostal window to use the hepatic window to assess the movement of the diaphragm. We will performed the measure of the diaphragm excursion with patient in semi-recumbent position and through a transhepatic transverse oblique scan while the patient is on mechanical ventilation and undergo a Pimax maneuver, that consists in a temporary occlusion of the airway with an expiratory pause. We will performed the measure three times, and we will take into account the best one made by the patient.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pimax and diaphragm inspiratory excursion | To assess the correlation between maximum inspiratory pressure (Pi max) and the diaphragm maximum inspiratory excursion measured with ultrasound. | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Predicting value of diaphragm excursion | To assess the predicting value of the diaphragm maximum inspiratory excursion measured with ultrasound for the weaning success. | 4 months | 
| Combination index prediction for weaning | To assess if the diaphragm maximum inspiratory excursion measured with ultrasound alone or in combination with other index (RSBI, Δtdi%) can predict the weaning success. | 4 months |
Identification of Risk Factors for the Occurrence of High-grade Rhythm Disorders in Patients With ST-segment Elevation Myocardial Infarction (STEMI)

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to identify the risk factors for the occurrence of arrythmia in patient with stemi in prehospital management. We included 652 patients who presenting a STEMI from september 2017 to october 2020 and manage by physician in prehospital and bring to CHU of Dijon. We analyse and compare the caracteristics of a group of STEMI patients who presenting an arrythmia to an other groupe of STEMI patient without arrythmia

Official Title
-----------------
Identification of Risk Factors for the Occurrence of High-grade Rhythm Disorders in Patients With ST-segment Elevation Myocardial Infarction

Conditions
-----------------
Arrythmia -Myocardial Infarction

Intervention / Treatment
-----------------
* Other: collection of medical and socio-demographic data


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 18 years old, with STEMI, in prehospital patient, take by a medecine, bring to the CHU Dijon Exclusion Criteria: < 18 years old, without STEMI, no medical in prehospital

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 |
| --- | --- |
| with an arrythmia<br>patient suffering from STEMI and presenting an arrythmia | Other: collection of medical and socio-demographic data<br>* collection of medical and socio-demographic data<br>|
| without an arrythmia<br>patient suffering from STEMI and not presenting an arrythmia | Other: collection of medical and socio-demographic data<br>* collection of medical and socio-demographic data<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| arrhythmia | arrhythmia during acute STEMI | at baseline |
Arsucam® (Artesunate + Amiodaquine) Efficacy and TOLerance

Study Overview
=================
Brief Summary
-----------------
Primary Objective: To demonstrate the non-inferiority, in terms of clinical and parasitological efficacy on Day 14, of administration of Arsucam® as a single daily intake versus two daily intakes. Secondary Objective: To compare the clinical safety of the two treatment regimens.

Official Title
-----------------
Randomised, Comparative Study of the Efficacy and Safety of Arsucam® Administered as a Single Daily Intake Versus Two Daily Intakes in the Treatment of Plasmodium Falciparum Malaria Attack

Conditions
-----------------
Malaria

Intervention / Treatment
-----------------
* Drug: Artesunate
* Drug: Amodiaquine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: weighing ≥ 10 kg residing in the area covered by the investigating centre throughout the entire follow-up period axillary temperature ≥ 37.5 degrees Celsius or history of fever within the previous 24 hours Plasmodium falciparum density in the blood ranging from 1000 to 100,000 asexual forms per cubic millimetre Exclusion Criteria: presence of at least one sign of severe malaria or clinical danger sign : prostration, consciousness disorders, recent and repeated convulsions , respiratory distress, inability to drink, uncontrollable vomiting, macroscopic haemoglobinuria, jaundice, haemorrhagic shock, systolic Blood Pressure < 70 mmHg in adults or < 50 in children, spontaneous bleeding, inability to sit or stand serious concomitant disease allergy to one of the investigational medicinal products pregnant women or breast-feeding women. documented intake of an antimalarial at a suitable dosage within seven days prior to inclusion.
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: Artesunate|nan|
|Drug: Amodiaquine|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| clinical and parasitological cure on Day 14 |  |  | 
| Secondary: incidence and severity of adverse events |  |  |
PSU Lumbar Support for Prevention of Low Back Pain in Rubber Tapper

Study Overview
=================
Brief Summary
-----------------
This study aims to evaluate the efficacy of lumbar support for low back pain prevention in rubber tapper. The investigators will randomized the participants(rubber tapper) into 2 groups;lumbar support and no support.The participant will be instructed for brace use. The sample size required are 200 subjects with 100 in each group. The subject will be evaluated every 3 month for the incidence of low back pain and quality of life after using the support.

Official Title
-----------------
Lumbar Support for Low Back Pain Prevention in Rubber Tapper

Conditions
-----------------
Low Back Pain

Intervention / Treatment
-----------------
* Device: PSU lumbar back support


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: current rubber tapper Exclusion Criteria: underlying rheumatologic condition previous significant low back pain previous back surgery

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 60 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: back exercise<br>strengthening back exercise | Device: PSU lumbar back support<br>* wear PSU back supprt during doing rubber tapper<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of low back pain |  | 6 month, 1 and 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Roland Moris score |  | 6 month, 1 and 2 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lumbar support, rubber tapper
Anti-adhesion Effect of GUARDIX-SGⓇ in Gastric Cancer Surgery

Study Overview
=================
Brief Summary
-----------------
This study is to evaluate the efficacy of GUARDIX-SGⓇ for patients with gastrectomy in Korea and the investigators hypothesized applying of adhesive preventing agent would reduce incidence of adhesive obstruction after gastrectomy.

Detailed Description
-----------------
Adhesive bowel obstruction is relatively often complication in patients after abdominal surgery Gastric cancer is the most frequent cancer in Korea. The incidence of adhesive bowel obstruction would be increased in patients with gastric cancer, especially associated radical lymphadenectomy. The causes of postoperative adhesive obstruction include adhesion of the wound, adhesion of small intestine to small intestine, adhesion of the small intestine to other abdominal organs, and internal hernia. Several studies reported efficacy of adhesive preventing agent after colorectal resection. Gastrectomy is associated with a high risk (incidence, 11.7%-38.5%) of bowel obstruction. To date, however, no randomized study has shown that GUARDIX-SGⓇ reduces the rate of small bowel obstruction after gastrectomy with radical lymphadenectomy for gastric cancer.

Official Title
-----------------
Prospective Multicenter Trial for Anti-adhesion Effect of GUARDIX-SGⓇ Following Radical Gastrectomy in Patients With Gastric Cancer.

Conditions
-----------------
Adhesive Intestinal Obstruction

Intervention / Treatment
-----------------
* Device: GUARDIX-SG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with gastric adenocarcinoma who scheduled to undergo open gastrectomy Informed consents Exclusion Criteria: Pregnant Ascites Liver dysfunction Renal failure Past history of abdominal operation or small bowel obstruction

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: GUARDIX<br>no guadix | |
| Experimental: guadix<br>guadix treatment | Device: GUARDIX-SG<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of adhesive intestinal obstruction | the incidence of adhesive bowel obstruction between using GUARDIX-SG group and control group | up to 1 years after operation (every 3 month) |
Use of Minocicline in Patients With Stroke

Study Overview
=================
Brief Summary
-----------------
The investigators will evaluate the National Institute of Health Stroke Scale/Score (NIHSS)in patients with stroke, and then give Minocycline 100mg po every 12 hours or placebo for five days, then perform periodic evaluations to determine the status and degree of neurological sequelae developed.

Official Title
-----------------
Effect of Minocicline Use in Less Neurologic Sequels in Patients With Stroke

Conditions
-----------------
Stroke, Brain Ischemia, Paralysis

Intervention / Treatment
-----------------
* Drug: Minocicline
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: NIHSS scale greater than 5 Onset of symptoms less than 24 hours normal Cranial Tomography(CT) CT evidence of cerebral ischemia Acceptance of study entry Exclusion Criteria: Hemorrhagic cerebrovascular disease Other neurological diseases Concomitant structural damage History of neurosurgery Known allergy to tetracyclines Concomitant infectious diseases requiring antibiotic treatment. History of Stroke Women pregnant or breast-feeding

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Minocicline<br>minocicline 100mg oral twice a day for 5 days | Drug: Minocicline<br>* Minocicline 100mg oral twice a day for 5 days<br>|
| Placebo Comparator: Placebo<br>Pills filled with vegetal fiber with similar presentation of the drug. Given one pill oral twice a day for five days | Drug: Placebo<br>* Pills with vegetable fibers one pill oral twice a day for five days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine the efficacy of minocycline in reducing neurological sequelae in patients with stroke | The researchers evaluated the neurological condition of paralysis, aphasia,and level of consciousness by NIHSS score for each patient with stroke and proceeded to give minocycline or placebo. Then, the assessment was repeated after five and thirty days post treatment to determine whether their neurological sequelae had diminushed. | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Identify the side effects of the intervention administered during the treatment time and 30 days later. |  | one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
stroke, sequelaes, minocicline
Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy

Study Overview
=================
Brief Summary
-----------------
Minimal hepatic encephalopathy represents a common complication present in well-compensated cirrhotic patients that impairs patients daily functioning and health-related quality of life. Acetyl-L-carnitine has been shown to be useful in improving blood ammonia and cognitive functions in cirrhotic patients with minimal hepatic encephalopathy. This study evaluated the effects of acetyl-L-carnitine treatment on health related quality of life and on depression in patients with minimal hepatic encephalopathy.

Official Title
-----------------
Acetyl-L-Carnitine Reduces Depression and Improves Quality of Life in Patients With Minimal Hepatic Encephalopathy

Conditions
-----------------
Minimal Hepatic Encephalopathy

Intervention / Treatment
-----------------
* Drug: Acetyl-L-Carnitine
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients diagnosed as having cirrhosis at the outpatient Internal Medicine of the Department of Senescence of Cannizzaro Hospital (Catania) were candidates for enrolment. The diagnosis of cirrhosis was based on clinical, biochemical and ultrasonographic or liver histological data. Exclusion Criteria: Exclusion criteria were overt hepatic encephalopathy or a history of overt HE; history of recent alcohol intake; infection; recent antibiotic use or gastrointestinal bleeding; history of recent use of drugs affecting psychometric performances like benzodiazepines, antiepileptics or psychotropic drugs; a history of shunt surgery or transjugular intrahepatic portosystemic shunt for portal hypertension; electrolyte imbalance; renal impairment; hepatocellular carcinoma; severe medical problems such as congestive heart failure, pulmonary disease or neurological or psychiatric disorder that could influence quality of life measurement; inability to perform neuropsycological tests.

Ages Eligible for Study
-----------------
Minimum Age: 34 Years
Maximum Age: 67 Years

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

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: Acetyl-L-Carnitine<br> | Drug: Acetyl-L-Carnitine<br>* 2 g acetyl-L carnitine twice a day<br>|
| Placebo Comparator: placebo<br> | Other: placebo<br>* placebo twice per day<br>|

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
-----------------
Acetyl-L-carnitine;, Minimal hepatic encephalopathy;, Quality of life;, Depression.
Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Ovarian Cancer

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effect of OPT-822/OPT-821 on improving Progression-Free Survival (PFS) in subjects who have non-progressive epithelial ovarian, fallopian tube, or primary peritoneal cancer after cytoreductive surgery and platinum-based chemotherapy as initial treatment for primary disease or as salvage treatment for first relapse.

Official Title
-----------------
An Open Labeled Phase II Trial of Active Immunotherapy With Globo H-KLH (OPT-822/821) in Women Who Have Non-Progressive Epithelial Ovarian, Fallopian Tube, or Primary Peritoneal Cancer

Conditions
-----------------
Ovarian Cancer

Intervention / Treatment
-----------------
* Biological: OPT-822/OPT-821


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Female subjects ≥ 21 years of age with histologically confirmed ≥ stage II epithelial ovarian, fallopian tube, and primary peritoneal cancer at diagnosis Who have not progressed after initial treatment with cytoreductive surgery and at least 4 cycles of platinum-based chemotherapy. OR Female subjects ≥ 21 years of age with first relapsed epithelial ovarian, fallopian tube, and primary peritoneal cancer (regardless of stage at diagnosis) Who have not progressed after received at least 4 additional cycles of platinum-based chemotherapy with or without having undergone secondary cytoreductive surgery . Exclusion Criteria: Subjects with evidence of disease progression according to the GCIG CA125 criteria or RECIST 1.1 criteria. Subjects who are currently receiving any other concomitant anticancer therapy. Subjects with evidence of extra-abdominal metastasis.

Ages Eligible for Study
-----------------
Minimum Age: 21 Years

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

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: OPT-822/OPT-821<br> | Biological: OPT-822/OPT-821<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression Free Survival (PFS) |  | Until disease progression or up to 5 years after the enrollment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Recurrence Rate |  | At 2 years after the enrollment |