linjc16/ctgov huggingface dataset:
Non-Interventional Study on Safety of Liraglutide in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Asia. The aim of this trial is to investigate the safety profile of liraglutide under normal conditions of use.

Official Title
-----------------
Liraglutide Effectiveness and Safety Data From Routine Clinical Practice in Philippines Study. A Multicentre, Open Label, Observational, Non-interventional Study to Evaluate the Safety and Effectiveness of Liraglutide in Subjects With Type 2 Diabetes Mellitus in Philippines

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

Intervention / Treatment
-----------------
* Drug: liraglutide


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with type 2 diabetes mellitus, including newly-diagnosed subjects or those already receiving other anti-diabetic medications including GLP-1 analogues other than Liraglutide, who require treatment with liraglutide according to the clinical judgment of their treating physician Subjects who are capable of giving study-specific signed informed consent before any collection of information Exclusion Criteria: Subjects with type 1 diabetes Subjects who are or have previously been on liraglutide Subjects who are participating in another clinical trial Subjects with a hypersensitivity to liraglutide or to any of the excipients (Disodium phosphate dihydrate, propylene glycol, phenol, water for injections) Subjects who are pregnant, breast feeding or have the intention of becoming pregnant within the following 6 months
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Liraglutide<br> | Drug: liraglutide<br>* Liraglutide will be prescribed and titrated by the treating physician and will be self-administered by the subject s.c. (under the skin) once daily. Study participants being treated with GLP-1 (Glucagon-Like Peptide 1)agonists or DDP-4-inhibitors (Dipeptidyl-peptidase 4 ) should stop treatment when initiating liraglutide treatment.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of serious adverse drug reactions (SADRs) |  | Week 0, week 26 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse drug reactions (ADRs) |  | Week 0, week 26 | 
| Incidence of serious adverse events (SAEs) |  | Week 0, week 26 | 
| Frequency of hypoglycaemic episodes |  | Week 0, week 26 | 
| Change in HbA1c (glycosylated haemoglobin) |  | Week 0, week 26 |
Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine

Study Overview
=================
Brief Summary
-----------------
The main objective is to evaluate the sensitivity of the EPA® for screening for malnutrition in general medicine in adults.

Official Title
-----------------
Analysis of EPA® (a Food Intake Assessment Tool) as a Screening Test for Malnutrition in General Medicine

Conditions
-----------------
Malnutrition

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: To be an adult, Consulting the principal investigator, a general practitioner in his activity of substitute doctor, During the inclusion period, Not opposed to participating in the study. Exclusion Criteria: Patients benefiting from artificial nutrition, Patients with advanced dementia, Pregnant or postpartum women, Patients who do not understand or speak French, Patients treated with diuretics who have had a change in treatment dosage during the last 6 months, Patients for whom weight measurement is not possible in the office (wheelchair, disability ...), Patients who have already been included once, Patients who have had surgery for obesity, Major persons subject to legal protection (legal safeguards, guardianship, tutorship), persons deprived of their liberty, ...

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 |
| --- | --- | --- |
| presence or absence of malnutrition | presence or absence of malnutrition based on BMI and / or percentage of weight loss | The inclusion day | 
| Score EPA | score obtained with the EPA® tool (assessment of food intake) | The inclusion day |
Correlation Between MRS (Magnetic Resonance Spectroscopy) and Tumor Response to Radiation Therapy in Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Correlation between MRS and Tumor Response Therapy in Breast Cancer.

Detailed Description
-----------------
Correlation between MRS (Magnetic Resonance Spectroscopy and Tumor Response to Radiation in Breast Cancer

Official Title
-----------------
Correlation Between MRS (Magnetic Resonance Spectroscopy) and Tumor Response to Radiation Therapy in Breast Cancer

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Device: MRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Histologically confirmed diagnosed Breast cancer Patient is 18 years or older Karnofsky performance score > 70 No previously irradiated or recurrent breast cancer No contraindication to MRS/MRI Signed informed consent.

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

| Intervention/Treatment |
| --- |
|Device: MRS|Procedure|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| MRS Correlation with Treatment Response | measuring choline, water and fat levels by proton magnetic resonance spectroscopy in breast tumors in response to treatment | Up to One Year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation with Tumor Stage |  | Up to One year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
MRS, cancer, Treatment response
The Measurement Of Cerebral Oxygenisation With NIRS Method İn Polycythaemic Infants Might Add A Criterion To Indicate PPET?

Study Overview
=================
Brief Summary
-----------------
Near infrared spectrophotometry (NIRS) offers the possibility of noninvasive and continuous bedside investigation of cerebral , renal, mesenteric and peripheric oxygenation and hemodynamics, and changes in newborn period.The aim of the present study is to investigate cerebral oxygenation with NIRS method in polycythaemic infants who underwent partial exchange transfusion.

Conditions
-----------------
Cerebral Oxygenation, Peripheric Oxygenation, Polycythaemic Infants

Intervention / Treatment
-----------------
* Device: INVOS 5100


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: term (≥37wk) infants whom determined ≥ 65% haematocrit(Hct) levels Exclusion Criteria: Infants with severe congenital malformation, sepsis, intracranial hemorrhage, birth asphyxia were excluded from the study.

Ages Eligible for Study
-----------------
Minimum Age: 4 Hours
Maximum Age: 48 Hours

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 |
| --- | --- |
| study group, control group<br> | Device: INVOS 5100<br>* Near-infrared range and has been used in newborn infants since 1985. Fibre-optic bundles or optodes are placed either on opposite sides of the tissue being interrogated (usually a limb or the head of a young baby) to measure transmitted light, or close together to measure reflected light. Light enters through one optode and a fraction of the photons is captured by a second optode and conveyed to the measuring device. NIRS uses a frequency band between 650 nm and 1000 nm and relies on three important phenomena: (1) human tissue is relatively transparent to light in the near-infrared region of the spectrum; (2) pigmented compounds known as chromophores absorb light as it passes through biological tissue; and (3) human tissues contain substances whose absorption spectra at near-infrared wavelengths are well defined and depend on their oxygenation status.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cerebral oxygenation measurement |  | 6 months |
Efficacy Study of Intramuscular or Intracoronary Injection of Autologous Bone Marrow Cells to Treat Scarred Myocardium

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the administration of patient's own bone marrow cells into scar areas of the heart, can improve the contractile function of these areas.

Official Title
-----------------
Efficacy of the Mode of Delivery of Autologous Bone Marrow Cells Into Heart Scar Muscle for the Recovery of Contractile Function

Conditions
-----------------
Myocardial Infarct, Bone Marrow Cells

Intervention / Treatment
-----------------
* Procedure: Control
* Procedure: Intramuscular administration of bone marrow cells
* Procedure: Intracoronary administration of bone marrow cells


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients undergoing elective CABG chronic irreversible myocardial scar coronary vessel supplying the scar must be amenable to bypass grafting Exclusion Criteria: significant valvular heart diseases major organ failures, eg. heart, liver, renal etc pre-existing bone marrow conditions

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control<br> | Procedure: Control<br>* Coronary artery bypass grafting without bone marrow cells injection<br>|
| Experimental: Intramuscular<br> | Procedure: Intramuscular administration of bone marrow cells<br>* Coronary artery bypass grafting, and intramuscular administration of bone marrow cells into myocardial scar<br>|
| Experimental: Intracoronary<br> | Procedure: Intracoronary administration of bone marrow cells<br>* Coronary artery bypass grafting, and intracoronary administration of bone marrow cells into myocardial scar<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contractile function of treated scar areas |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Global left ventricular functions |  | 6 months |
Safety and Efficacy Study of Autologous Cultured Adipose -Derived Stem Cells for the Crohn's Fistula

Study Overview
=================
Brief Summary
-----------------
Up to date, a sure cure for Crohn's fistula has not known and the fistula recurrence rate is high. On 15 October 2008, orphan drug designation was granted by Korea FDA to Anterogen Co. Ltd., for human adipose-derived stem cell. In this study, patients are given injection of ADIPOPLUS in fistula site and followed for 8 weeks to test the safety and efficacy.

Official Title
-----------------
A Phase I Dose Escalation Clinical Study of ADIPOPLUS (Autologous Cultured Adipose-derived Stem Cell) for the Treatment of Crohn's Fistula to Evaluate Safety and Efficacy

Conditions
-----------------
Crohn's Fistula

Intervention / Treatment
-----------------
* Drug: ADIPOPLUS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Older than 18 years Prior diagnosis of Crohn's disease patients who have Crohn's fistula negative for urine beta-HCG for woman of childbearing age agreement to participate, with signed informed-consent Exclusion Criteria: patients who have allergy to bovine-derived materials or an anesthetic patients with a diagnosis of auto immune disease except for Crohn's disease Diagnosis of HBV, HCV, HIV and other infectious disease Patients who have a symptom of septicemia Patients with a diagnosis of active Tuberculosis Patients who are pregnant or breast-feeding Patients who are unwilling to use an effective method of contraception during the study Patients with a diagnosis of Inflammatory Bowel Disease except for Crohn's disease Patients who is sensitive to Fibrin glue Patients who have a clinically relevant history of abuse of alcohol or drugs Insufficient adipose tissue for manufacturing of ADIPOPLUS Patients who are considered not suitable for the study by investigator Patients who have history of surgery for malignant cancer in the past 5 years

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: autologous adipose derived stem cell<br> | Drug: ADIPOPLUS<br>* autologous adipose-derived stem cell<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy: closure of fistula at week 8 Safety: - Clinically measured abnormality of laboratory tests and adverse events |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Closure of fistula |  | week 4 | 
| Investigator satisfaction |  | week 4 and week 8 | 
| Patient satisfaction |  | week 4 and week 8 | 
| Digital photography |  | day 1, week 4 and week 8 |
Effects of Acleara Needle Insert on Acne

Study Overview
=================
Brief Summary
-----------------
This prospective, open-label study will be conducted in 15 healthy subjects per clinical site ages 14 or older who meet the inclusion/exclusion criteria. Each subject may have up to 5 lesions treated on the face, chest or back with the Acleara insert. Subjects will receive up to 3 follow up visits and evaluated for improvement in acne lesions and monitored for any adverse events.

Official Title
-----------------
A Clinical Trial Investigating the Effects of Acleara Needle Insert on Acne Vulgaris

Conditions
-----------------
Acne Vulgaris

Intervention / Treatment
-----------------
* Device: Acleara Acne Treatment System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects >14 years of age Subject has mild to moderate acne vulgaris on the face, chest or back. Subject has one or more inflammatory acne lesions on face, chest or back. Willingness to participate in the study Informed consent agreement signed by the subject Willingness to follow the treatment schedule and post treatment care requirements Willingness to remain on current acne therapy as directed by the Investigator. Exclusion Criteria: Subject has an infection or other dermatologic condition (aside from acne) in the area to be treated Subject is immunosuppressed Subject is unable to comply with treatment or follow-up visits Any other condition or laboratory value that would, in the professional opinion of the investigator, potentially affect the subject's response or the integrity of the data or would pose an unacceptable risk to the subject.

Ages Eligible for Study
-----------------
Minimum Age: 14 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Acleara Acne Treatment System|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subject assessment of reduction in acne lesion size | Percentage range of lesion reduction | 24-72 hours, 1-2 weeks, 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
acne, inflammatory acne, intense pulsed light
Changes of Keratometric Value and Ocular Aberration After Treatment of Meibomian Gland Dysfunction

Study Overview
=================
Brief Summary
-----------------
Ocular aberration may play a role in determining optical quality. Recently performed study reported that ocular aberration of preocular tear film would be important factor in not only diagnosing the dry eye but also determining the efficacy of treatment. Therefore, in this study, the investigators will aim to prove the improvement of quality of vision via ocular aberration changes indirectly after the proper treatment for moderate and severe meibomian gland dysfunction. Also, the investigators will evaluate the changes of keratometric values after treatment for moderate and severe meibomian gland dysfunction, which could be demonstrated by autokeratometry, IOLMaster, Pentacam, and iTrace.

Conditions
-----------------
Moderate and Severe Meibomiang Gland Dysfunction (Stage 3 or Stage 4 Meibomiang Gland Dysfunction)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: (1) stage 3 or 4 meibomian gland dysfunction Exclusion Criteria: history of previous ocular or intraocular surgery ocular infection, non dry eye ocular inflammation, ocular allergy, autoimmune disease, history of intolerance or hypersensitivity to any component of the study medications, wearing contact lenses during the study period, presence of current punctal occlusion, pregnancy, lactating women, and children. Additionally, patients were excluded if they were using any topical ocular or systemic medication that could be used for the treatment MGD or dry eye, including topical or oral antibiotics, topical cyclosporine A, topical or oral steroids, topical non-steroidal anti-inflammatory drugs, topical ocular allergy medications or artificial tears

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| stage 3 or stage 4 meibomiang gland dysfunction patients<br>stage 3 or stage 4 meibomiang gland dysfunction patients | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of keratometric value and ocular aberration |  | a minimum of four minutes, once or twice dailybefore treatment, after 1 month, and after 2 months of treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
meibomian gland dysfunction, keratometric value, ocular aberration
Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia

Study Overview
=================
Brief Summary
-----------------
The overall objective of this pilot study is to determine whether multispectral imaging increases the diagnostic accuracy of the current standard of high-definition white-light endoscopy for the detection of Barrett's-associated neoplasia (high grade dysplasia or cancer). The investigators goal is to develop a multispectral endoscopic platform that can be used to survey a large surface area and, potentially, serve as a 'red flag' for microendoscopic imaging of small areas. The goal of this pilot study is to preliminarily determine the accuracy of these modalities during the endoscopic surveillance of Barrett's esophagus.

Official Title
-----------------
Endoscopic Multispectral Imaging for the Early Detection of Barrett's Neoplasia

Conditions
-----------------
Barrett's Esophagus, Intraepithelial Neoplasia

Intervention / Treatment
-----------------
* Drug: proflavine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years or older known or suspected barrett's esophagus with intraepithelial neoplasia(HGD/cancer) Exclusion Criteria: -

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: Screening
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: treatment<br>fluorescent imaging with proflavine | Drug: proflavine<br>* 2-6 ml of 0.01% proflavine<br>* Other names: Proflavine hemisulfate;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to determine whether tissue is neoplastic or non-neoplastic |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
barrett's esophagus, intraepithelial neoplasia, cross polarized reflectance examination, vital-dye enhanced fluorescence examination