linjc16/ctgov huggingface dataset:
Metformin Plus Irinotecan for Refractory Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
MetIri seeks to identify if metformin combined to irinotecan can improve tumor control.

Detailed Description
-----------------
MetIri is a two-stage single arm Phase II assessing the role of combination of metformin to irinotecan for colorectal cancer patients already treat with oxaliplatin, fluoropyrimidine, irinotecan and an anti-EGFr antibody if KRAS wild-type.

Official Title
-----------------
Phase II Trial of Metformin Combined to Irinotecan for Refractory Metastatic or Recurrent Colorectal Cancer

Conditions
-----------------
Colorectal Neoplasms, Adenocarcinoma

Intervention / Treatment
-----------------
* Drug: metformin
* Drug: irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older Biopsy-proven colorectal adenocarcinoma Ineligibility for curative intent therapy, e.g., surgery or radiation Disease progression after oxaliplatin (either adjuvant or palliative), fluoropyrimidine (either adjuvant or palliative), irinotecan, and if Kras wild type a anti-EGFR therapy Assessable disease according to RECIST v1.1 Exclusion Criteria: known hypersensitivity to metformin or irinotecan Uncontrolled Central nervous system metastasis Acute or chronic severe infection

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metfomin + irinotecan<br>Irinotecan 350mg/m² q21d + metformin up to 2500mg/d until disease progression, prohibitive toxicity or consent withdrawal | Drug: metformin<br>* metformin up to 2500mg/d<br>Drug: irinotecan<br>* Irinotecan 350 mg/m² IV q21d<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Progression at week 12th of treatment | Non-Progression at week 12th of treatment | 12th week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | Progression-free survival | 12th week | 
| Overall Survival | Overall Survival | 12th week | 
| Quality of life | Measured by EORTC QLQ C30 | 12th week | 
| Safety | Assessment of toxicity according to CTC 4.0 | 12th week | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metformin, colorectal cancer, chemotherapy
Topcon 3D OCT-1 Maestro Reference Database Study II

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.

Detailed Description
-----------------
The objective of this study is to collect OCT measurement data on normal healthy eyes in order to determine the reference limits for Topcon 3D OCT-1 Maestro based on the percentile points for 1%, 5%, 95%, and 99%.

Official Title
-----------------
Topcon 3D OCT-1 Maestro Reference Database Study II

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

Intervention / Treatment
-----------------
* Device: 3D OCT-1 Maestro


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria for Normal Group Subjects 18 years of age or older on the date of informed consent Subjects able to understand the written informed consent and willing to participate as evidenced by signing the informed consent Subjects presenting at the site with normal eyes (eyes without pathology) lOP <= 21 mmHg bilaterally BCVA 20/40 or better (each eye) Both eyes must be free of eye disease Exclusion Criteria for Normal Group Subjects previously enrolled in either the Maestro AP study or the Maestro2 study Subjects unable to tolerate ophthalmic imaging Subject with ocular media not sufficiently clear to obtain acceptable OCT images HFA visual field (24-2 Sita Standard, white on white) result unreliable (based on manufacturer's recommendation), defined as fixation losses > 20% or false positives> 33%, or false negatives> 33% Visual field defects consistent with glaucomatous optic nerve damage based on with at least one of the following two findings: On pattern deviation (PD), there exists a cluster of 3 or more points in an expected location of the visual field depressed below the 5% level, at least 1 of which is depressed below the 1% level; Glaucoma hemi-field test outside normal limits. Presence of any ocular pathology except for cataract Narrow angle History of leukemia, dementia or multiple sclerosis Concomitant use of hydroxychloroquine and chloroquine

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 |
| --- | --- |
| Normal Eyes<br>Subjects with no known ocular diseases will be scanned with the Maestro device | Device: 3D OCT-1 Maestro<br>* OCT machines used for diagnostic purposes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retinal Thickness |  | 1 minute | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Volunteers with Healthy Eyes
Comparison of Skin Substitutes Used in Burn Care

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if using a DERMAL LAYER under skin grafts: will reduce scar formation of skin grafts will reduce burn wound contractures will improve functional outcome of joints requiring grafts Compare scarring outcome of Dermal products

Detailed Description
-----------------
Various skin substitutes are compared for healing, scar and functional and cosmetic outcomes.

Official Title
-----------------
The Use of Alloderm and Other Skin Substitutes in Acute Burn Treatment and Burn Scar Reconstruction

Conditions
-----------------
Burns

Intervention / Treatment
-----------------
* Procedure: Integra
* Procedure: AlloDerm
* Procedure: Homograft
* Procedure: Autograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Burn injury requiring grafting 0 years-90 years Exclusion Criteria: Partial thickness burns only

Ages Eligible for Study
-----------------
Maximum Age: 90 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: Alloderm, Integra, Homograft, Autograft<br>Burn debridement and grafting using interventions of 1) AlloDerm, 2) Integra, 3) Homograft and 4) Autograft on four separate sites on each patient | Procedure: Integra<br>* Grafting using the Commercial product Integra as a skin substitute over full thickness burn following excision.<br>* Other names: Artificial dermis;Procedure: AlloDerm<br>* Grafting using the commercial product AlloDerm as a skin substitute<br>* Other names: Cadaver skin;Procedure: Homograft<br>* Grafting using homograft as a skin substitute<br>* Other names: Cadaver Skin;Procedure: Autograft<br>* grafting using patients own skin from a separate donor site<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Burn Scar Comparison | Burn scar is measured scar using the Vancouver Scar Scale (range 0-12) for each of the various skin substitutes used in grafting. Vancouver Scar Scale measure burn scarring assessing categories of redness/vascularity, hardness, pigmentation and scar height. Each item has a scale of 0-3. Score for each category is summed together for a total score between 0-12. The total score is generally used in the burn community, therefore the total score will be reported. Lower scores are better; higher scores are worse. | 2 years post burn injury | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burns, Skin grafting, AlloDerm, Integra, Homograft, Autograft, Burn Scar
Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE)

Study Overview
=================
Brief Summary
-----------------
The aim of this study of this study is to compare two protocol of maxillary protraction in class III adolescent after using (MSE) Alt-RAMEC vs conventional rapid palatal expansion using cone beam computed tomography (CBCT)

Official Title
-----------------
Evaluation of Two Protocol of Maxillary Protraction in Class III Adolescent After Using (MSE) Alt-RAMEC vs Conventional Rapid Palatal Expansion Randomized Controlled Trial -CBCT Study

Conditions
-----------------
Maxillary Protraction in Class III Adolescent After Using (MSE)

Intervention / Treatment
-----------------
* Device: Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol.
* Device: Maxillary skeletal expander with protraction face mask with conventional protocol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Class3 Patients suffering maxillary collapse with a skeletal background Patients with retrognathic maxilla. Patients with anterior cross-bite or incisor end-to-end relationship Patients with unilateral or bilateral posterior crossbite. Patients with no periodontal disease. Patients with good oral hygiene and general health. No systemic diseases that may affect bone quality or interfere with orthodontic treatment. Patients with no previous orthodontic treatment. Exclusion Criteria: previous orthodontic treatment. Craniofacial syndrome.

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 17 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: (MSE) Alt-RAMEC protocol<br> | Device: Maxillary skeletal expander with protraction face mask with Alt-RAMEC protocol.<br>* The current study was conducted on a total sample of 21 young adult orthodontic patients presented with class 3 retrognathic maxilla with or without transverse maxillary deficiency by Alt-RAMEC protocol.<br>|
| Active Comparator: (MSE) conventional protocol<br> | Device: Maxillary skeletal expander with protraction face mask with conventional protocol<br>* The current study was conducted on a total sample of 21 young adult orthodontic patients presented with class 3 retrognathic maxilla with or without transverse maxillary deficiency by conventional protocol<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| amount of maxillary protraction | protraction of maxilla using CBCT | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Expansion, maxillary protraction, class III
A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System

Study Overview
=================
Brief Summary
-----------------
The overall objective of this study is to determine the safety and usability of OMNI surgical system in performing canaloplasty and trabeculotomy. Outcome measures will include 1) adverse events (intraoperative and perioperative) 2) BCVA 3) Secondary surgical interventions 4) mean IOP and 5) mean number of hypotensive medications

Official Title
-----------------
A Single Center Proof Of Concept Study To Assess Intra And Perioperative Safety Profile Of OMNI Surgical System

Conditions
-----------------
Open Angle Glaucoma

Intervention / Treatment
-----------------
* Device: OMNI Surgical System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects, 22 years or older. Visually significant cataract or pseudophakic with a posterior chamber intraocular lens (PCIOL) Diagnosed with open angle glaucoma (e.g. primary open angle glaucoma, pigmentary glaucoma, pseudoexfoliative glaucoma) Scheduled for canaloplasty and trabeculotomy Exclusion Criteria: Any other intraocular surgery at the time of canaloplasty and trabeculotomy excepting cataract surgery for those subjects with cataract. Prior trabeculectomy, other bleb-forming glaucoma surgery (e.g. tube shunt), or implanted trabecular bypass stents. Any other ocular pathologies that may interfere with the study procedure or be exacerbated by the OMNI procedure.

Ages Eligible for Study
-----------------
Minimum Age: 22 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: Diagnosed with open angle glaucoma<br> | Device: OMNI Surgical System<br>* Scheduled for canaloplasty and trabeculotomy with or without cataract extraction<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events (intraoperative and perioperative) |  | 3 months | 
| Best Corrected Visual Acuity (BCVA) |  | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean intraocular pressure (IOP) |  | 3 months | 
| Mean number of ocular hypotensive medications |  | 3 months |
Phamacokinetics and Safety Profiles of DA-5210 10/1000mg in Healthy Subjects at Fed State

Study Overview
=================
Brief Summary
-----------------
Phamacokinetics and safety profiles of DA-5210 10/1000mg in Healthy subjects at Fed State

Official Title
-----------------
An Open Label, Randomized, Single Dose, Crossover Study to Evaluate the Pharmacokinetics and Safety of DA-5210 10/1000mg in Healthy Subjects at Fed State

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

Intervention / Treatment
-----------------
* Drug: DA-5210 10/1000mg
* Drug: DA-5210-R 10/1000mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Volunteers BMI between 18 and 30 kg/m2 Body weight : Male≥50kg, Female≥45kg Exclusion Criteria: Allergy or Drug hypersensitivity Clinically significant Medical History

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sequence A<br> | Drug: DA-5210 10/1000mg<br>* single dose administration (one tablet once a day)<br>Drug: DA-5210-R 10/1000mg<br>* single dose administration (one tablet once a day)<br>|
| Experimental: Sequence B<br> | Drug: DA-5210 10/1000mg<br>* single dose administration (one tablet once a day)<br>Drug: DA-5210-R 10/1000mg<br>* single dose administration (one tablet once a day)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| AUCt | area under the curve | pre-dose 48 hours post-dose | 
| Cmax | maximum plasma concentration | pre-dose 48 hours post-dose |
Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial

Study Overview
=================
Brief Summary
-----------------
This study is intended to compare the new Carnation patch monitoring system with the Zio patch, which represents the current standard for continuous recording of the ECG over extended periods.

Detailed Description
-----------------
The purpose of this research is to confirm the clinical value of a new P-wave sensitive recording vector combined with an easy-to-use long-term cardiac rhythm monitoring patch system, the CarnationTM Ambulatory Monitoring (CAM) System. The P-wave is a critical aspect of the electrocardiogram and a key finding for proper arrhythmia diagnosis. The CAM system is optimized for both ease of use and for maximum P-wave clarity for arrhythmia diagnosis.

Official Title
-----------------
Comparison of Continuous Sternal ECG Patch Monitors (Carnation and Zio) Trial

Conditions
-----------------
Syncope, Presyncope, Palpitations, Atrial Fibrillation, Supraventricular Tachycardia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Syncope of uncertain etiology or Pre-syncope of uncertain etiology or Palpitations of uncertain etiology or Management of known AF/SVT patients Exclusion Criteria: Any dermatitis or infected skin over the sternum (Carnation patch) or left upper anterior thorax (Zio patch). A sternal or thoracic incision that extends under the patch within 3 months from the date of enrollment

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ECG signal quality | ECG signal quality = scoring the ability of each system to record electrical activity from the atrium (P-waves). The Physician Event Committee will independently score the P-waves from all recordings, using the following scale: Excellent, Good, Fair, Poor, Non-existent. | 14 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Device comfort | Secondary outcome measures will include Human Factors performance of the 2 systems, which will be scored and compared in the following areas and duration of patch adherence: skin irritation, comfort, contact and stability. | 14 days |
Observatory of Food Preferences in Infants and Children

Study Overview
=================
Brief Summary
-----------------
Food habits form early in infancy and are likely to track into childhood until the beginning of adulthood. Understanding the factors driving the acceptance of foods in the early years is therefore of particular importance, since these foods will form the basis of a child's future food repertoire. This is especially important for vegetables, which consumption is recommended at all stages of life but is below the recommended levels and which acceptance is difficult to promote during late childhood. The objective of the present study was to unravel the respective contribution of maternal feeding practices, of children's rate of exposure to vegetables and of children's sensory reactivity factors over the course of the first two years, to explain the development of liking for vegetables at the age of 2 years. This analysis took advantage of data recorded in a prospective cohort of children recruited before birth and followed up longitudinally until the age of 2 years.

Detailed Description
-----------------
This study is a cohort study with the aim to evaluate prospectively food liking in children, at to relate this outcome to children's food experience, acceptance of taste and olfactory stimulation, and to parental feeding style.

Official Title
-----------------
Longitudinal Study of Food Liking in Eatrly Childhood

Conditions
-----------------
Eating Behavior

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant mothers older than 18 years Exclusion Criteria: Food allergies in the infant, as observed after the infant's birth

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Food likes (Evaluation of food likes for a list of 257 foods) | Evaluation of food likes for a list of 257 foods | 1-year prospective data collection |
Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to correlate Endoscopic Ultrasound (EUS) criteria for chronic pancreatitis with surgical pathology.

Official Title
-----------------
Endoscopic Ultrasound (EUS) Features of Chronic Pancreatitis: A Prospective Correlation With Intraoperative Findings and Surgical Pathology

Conditions
-----------------
Chronic Pancreatitis

Intervention / Treatment
-----------------
* Other: chronic pancreatitis


Participation Criteria
=================
Eligibility Criteria
-----------------
Patients who are eligible are individuals who have: normal pancreas suspected chronic pancreatitis established chronic pancreatitis (by ERCP, MRI, previous EUS, CT) pancreatic cancer Patients who are not eligible are individuals who have: • an uncorrectable coagulopathy (platelet <50,000, INR>1.5), or bleeding disorder, or are unable to discontinue anticoagulation 5-7 days prior to EUS (aspirin and bridging therapy with lovenox are allowed, clopidogrel is not allowed)

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 |
| --- | --- |
| Chronic Pancreatitis<br> | Other: chronic pancreatitis<br>* No intervention, subjects followed through surgery<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
-----------------
chronic pancreatitis