linjc16/ctgov huggingface dataset:
Early Administration of Bifidobacterium to Very Low Birth Weight Infants

Study Overview
=================
Brief Summary
-----------------
To evaluate the effects of early administration of probiotics on acceleration of enteral feeding, and on growth of very low birth weight infants, newborn infants with birth weight less than 1500g are administered Bifidobacterium bifidum twice a day.

Official Title
-----------------
Early Administration of Bifidobacterium Bifidum to Very Low Birth Weight Infants: A Pilot Study

Conditions
-----------------
Preterm Infants

Intervention / Treatment
-----------------
* Dietary Supplement: Administration of Bifidobacterium bifidum


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Very low birth weight infant Exclusion Criteria: Presence of major congenital malformations

Ages Eligible for Study
-----------------
Maximum Age: 7 Days

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

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

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

Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Eearly administration<br>Administration of Bifidobacterium within 48h after birth | Dietary Supplement: Administration of Bifidobacterium bifidum<br>* Administration of Bifidobacterium bifidum to very low birth weight infants<br>* Other names: Bifidobacterium bifidum OLB6378;|
| Active Comparator: Late administration<br>Administration of Bifidobacterium more than 48h after birth | Dietary Supplement: Administration of Bifidobacterium bifidum<br>* Administration of Bifidobacterium bifidum to very low birth weight infants<br>* Other names: Bifidobacterium bifidum OLB6378;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the day at total feeding volume reached 100ml/kg/day | the post natal day at total enteral feeding reached 100ml/kg/day | post natal day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| colonizatin of Bifidobacterium | the level of Bifidobacterium in feces from the study infants growth rate of the study infants the positive rate of MRSA colonization among the study infants adverse outcomes | 4 weeks after birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bifidobacterium bifidum, Very low birth weight infant, Enteral feeding, Growth, amount of enteral feeding
Patients Visit Prior to Hospital Admission & Intensive Care Unit

Study Overview
=================
Brief Summary
-----------------
The present study evaluates the effects of the visit prior to hospital admission on anxiety, depression and satisfaction of patients in an intensive care unit.

Official Title
-----------------
Effects of the Visit Prior to Hospital Admission on Anxiety, Depression and Satisfaction of Patients in an Intensive Care Unit

Conditions
-----------------
Anxiety, Depression, Intensive Care Unit Syndrome

Intervention / Treatment
-----------------
* Other: Patient visit prior to hospital admission


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient at hospital admission for surgery Exclusion Criteria: Cognitive impairment

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: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>Patient receiving one visit prior to hospital admission | Other: Patient visit prior to hospital admission<br>* Patient and family receiving one visit prior to hospital admission for surgery<br>|
| No Intervention: Control group<br>Patient without receiving one visit prior to hospital admission | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hospital Anxiety and Depression Scale | Anxiety subscale range from 0 to 21. Depression subscale range from 0 to 21. Higher values represent a worse outcome (higher depression or anxiety). | Change from Baseline anxiety and depression at 90 days |
Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the efficacy and safety of DWJ1506 and DWJ1507 in the patients with dyslipidemia.

Official Title
-----------------
A Randomized, Double-blind, Multi-center, Phase 3 Clinical Trial to Evaluate the Efficacy and Safety of DWJ1506 and DWJ1507

Conditions
-----------------
Dyslipidemias

Intervention / Treatment
-----------------
* Drug: DWJ1506
* Drug: DWJ1507
* Drug: DWC202011
* Drug: DWJ1177


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults aged 19 years or over Patients with LDL-C levels ≤ 250 mg/dL, TG < 500 mg/dL Subjects who voluntarily decided to participate and provided written consent after being told of the objectives, method, and effects of this study Exclusion Criteria: Severe congestive hear failure Current active liver disease The use of prohibiterd concomitant therapies Severe gastrointestinal diseases: active ulcer, gastrointestinal or rectal bleeding, active inflammatory bowel syndrome, biliary duct obstruction, active gastritis that is not controlled by medication, etc. 6.Women who were of childbearing potential without contraception, pregnant, or breastfeeding

Ages Eligible for Study
-----------------
Minimum Age: 19 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 |
| --- | --- |
| Experimental: DWJ1506<br> | Drug: DWJ1506<br>* DWJ1506<br>|
| Experimental: DWJ1507<br> | Drug: DWJ1507<br>* DWJ1507<br>|
| Active Comparator: DWC202011<br> | Drug: DWC202011<br>* DWC202011<br>|
| Active Comparator: DWJ1177<br> | Drug: DWJ1177<br>* DWC202011<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LDL-C levels at week 8 | Change from baseline in LDL-C level at week 8 after administration of the IP | Week 8 |
Hepatocellular Carcinoma in HIV-infected Patients

Study Overview
=================
Brief Summary
-----------------
Observational study. All HIV-infected patients who have been diagnosed of hepatocellular carcinoma (HCC), following the American Association for the Study of Liver Diseases (AASLD) criteria, in the participant centers are included. Epidemiological, clinical and laboratory data are collected. The clinical and epidemiological characteristics of HCC cases will be analyzed. The efficacy and outcomes after modalities of HCC therapy will be assessed. Mortality and its predictors will be also assessed. In those cases infected by hepatitis C virus (HCV), the impact of HCV therapy on outcomes will be analysed.

Official Title
-----------------
Hepatocellular Carcinoma in HIV-infected Patients

Conditions
-----------------
Hepatocellular Carcinoma, HIV, Chronic Hepatitis C, Hepatitis B Virus, Liver Cirrhosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV infection Diagnosis of hepatocellular carcinoma according to American Association for the Study of Liver Diseases (AASLD) criteria Exclusion Criteria: None

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 |
| --- | --- | --- |
| Overall survival | Overall survival after HCC diagnosis at 1 year | At 1 year |
Respiratory Muscle Contribution to Blood Pressure During Exercise

Study Overview
=================
Brief Summary
-----------------
The investigators seek to understand how reflexes from the breathing muscles influence blood pressure during exercise. Furthermore, the investigators are determining if increasing breathing muscle strength (via inspiratory muscle training) influences the respiratory muscle contribution to blood pressure during exercise.

Official Title
-----------------
Respiratory Muscle Contribution to Blood Pressure During Exercise in Healthy Humans

Conditions
-----------------
Blood Pressure, Respiratory Muscle, Exercise Capacity, Sympathetic Nerve Activity

Intervention / Treatment
-----------------
* Other: Inspiratory Muscle Training (IMT)
* Other: No Inspiratory Muscle Training (IMT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Healthy participants with no history of cardiovascular, pulmonary, neurologic, orthopedic or other neuromuscular diseases.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IMT Group<br> | Other: Inspiratory Muscle Training (IMT)<br>* Inspiratory muscle training (IMT) are breathing exercises used to increase strength and endurance of the respiratory muscles.<br>|
| Sham Comparator: No IMT Group<br> | Other: No Inspiratory Muscle Training (IMT)<br>* No inspiratory muscle training.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VO2 max test | Using a MedGraphics metabolic cart, the investigators will measure the maximum amount of oxygen that an individual can utilize during exercise. During this test the subject will be asked to exercise to his/her max capacity on a recumbent bicycle while breathing through a mouth piece that is hooked into the MedGraphics computer software. | Through study completion, an average of one year. | 
| Blood Pressure | Blood pressure will be taken every few minutes during exercise testing using a standard blood pressure cuff to monitor changes in blood pressure. | Through study completion, an average of one year. |
Secondary Endolymphatic Hydrops and Vestibular Schwannomas on 3 Tesla MRI

Study Overview
=================
Brief Summary
-----------------
Endolymphatic hydrops is well known of the lay public in its primary form that is Ménière disease. Nowadays, the best w ay to approach it in vivo, is to use magnetic resonance imaging (MRI). However, endolymphatic hydrops don't limit itself to its primary form but cover a whole range of pathologies. The hypothesis is that patients with vestibular schwannomas are more likely to develop secondary saccular hydrops. The aim is to compare high-resolution T2-weighted images of the saccule in patients followed up for vestibular schwannomas with healthy volunteers and histological sections from cadavers in order to identify its changes. The secondary purpose of The protocol is to determine if vestibular and audiometric abnormalities could be related to this secondary hydrops more specifically than to the tumor size and localisation.

Official Title
-----------------
Saccular Dilatation, Endolymphatic Hydrops and Vestibular Schwannoma : is Vertigo Really Correlated to the Tumor ? A Retrospective Study Based on FIESTA-C Sequence Using a 3 Tesla MRI

Conditions
-----------------
Vestibular Schwannoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age> 18, Subject having benefited from an MRI with T2 high-resolution 3D sequence (FIESA) in the context of the diagnosis of vestibular schwannoma between 2008 and 2017 at the University Hospitals of Strasbourg, Subject who has agreed to the use of medical data for the purposes of this research. Exclusion Criteria: Refusal of the patient to participate in the study Insufficient imaging data, Tumors already treated, Atypical tumors with uncertain diagnosis, intra-labrinthic or intra-labyrinthine schwannomas, concomitant infectious or inflammatory pathology in the middle or inner ear. Impossibility of giving the subject informed information (difficulty understanding the subject,) Subject under the protection of justice Subject under guardianship or curatorship

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence or absence of height and width of the saccule on MRI. |  | 1 hour after the realization of the MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Schwannoma, saccular dilatation, endolymphatic hydrops, magnetic resonnance imaging, vertigo
Preoperative Progression of Macular Holes

Study Overview
=================
Brief Summary
-----------------
Knowledge of the natural history and progression of macular holes is mainly limited to the studies from the pre-optical coherence tomography era. By observing macular holes preoperatively we are able to determine the extent of the preoperative macular hole progression. At our institution macular holes are treated in an elective setting. The majority of macular holes undergo a 2-step sequence of phacoemulsification and intraocular lens implantation followed by vitrectomy. We wish to observe the effect of time and cataract surgery on the progression of macular holes prior to vitrectomy.

Official Title
-----------------
Preoperative Progression of Macular Holes Using Optical Coherence Tomography

Conditions
-----------------
Macular Holes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Idiopathic macular hole stage II-IV Informed consent Duration of symptoms ≤ 24 months Exclusion Criteria: Previous vitreomacular surgery Ocular trauma Significant visual function affecting disease (proliferative diabetic retinopathy, diabetic macular edema, exudative macular degeneration)

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 120 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 |
| --- | --- |
| Phakic eyes<br>Phakic eyes will be monitored with 4 preoperative optical coherence tomography scans as these patients will undergo phacoemulsification and intraocular lens implantation prior to their macular hole surgery | |
| Pseudophakic eyes<br>Phakic eyes will be monitored with 2 preoperative optical coherence tomography scans as there is no surgical intervention prior to the macular hole treatment. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Macular hole Progression | Serial optical coherence tomography (OCT) measurements in the preoperative period. The size of macular hole is determined by measuring the macular hole minimal linear diameter (µm). Size and stage of macular hole is determined at primary evaluation at tertiary ophthalmic center. Initial scan is followed by pre-vitrectomy scan if patient is pseudophakic. Initial OCT scan is followed by pre- and postcataract as well as pre-vitrectomy OCT scan if patient is pseudophakic. | 3 months preoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Early Treatment Diabetic Retinopathy Study (ETDRS) Visual Acuity | Visual acuity in ETDRS letters measured 3 month postoperatively | 3 months postoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Macular Holes, Progression
A Bioequivalence Study of Tobramycin and Prednisolone Acetate Compared to PredForte

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate the bioequivalence of the combination test agent, prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension compared to PredForte (prednisolone acetate 1.0%) ophthalmic suspension. Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate.

Official Title
-----------------
A Multi-Center, Randomized, Double Masked, Bioequivalence Study of Tobramycin and Prednisolone Acetate (0.3/1.0%, ISTA) Ophthalmic Suspension Compared to PredForte (1.0% Prednisolone Acetate, Allergan) Ophthalmic Suspension

Conditions
-----------------
Eye Infections, Postoperative Complications

Intervention / Treatment
-----------------
* Drug: Prednisolone and Tobramycin
* Drug: Prednisolone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Bilateral cataract surgery Avoid disallowed medications throughout study Exclusion Criteria: Contraindications to the use of the test agents Known allergy or sensitivity to the test agents or components History of steroid response following topical administration of corticosteroids in the eye Wore contact lenses 48 hours prior to Visit 1 An intraocular pressure that is greater than 22 mmHg or less than 5 mmHg in either eye Any significant illness that could be expected to interfere with study Used ophthalmic, topical or systemic corticosteroids or an immunomodulator for 7 days prior to 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?
-----------------

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prednisolone and Tobramycin<br>Prednisolone acetate 1.0% and tobramycin 0.3% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction. | Drug: Prednisolone and Tobramycin<br> <br> |
| Active Comparator: Prednisolone<br>Prednisolone acetate 1.0% ophthalmic suspension. One drop of test agent will be instilled in the inferior cul de sac of the operative eye prior to cataract extraction. | Drug: Prednisolone<br> <br> * Other names: Pred Forte;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bioequivalence will be measured by comparing aqueous humor concentrations of prednisolone acetate at various time points | Comparison of aqueous humor concentrations of prednisolone acetate at various time points | 2 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cataract Extraction, Anti-Bacterial Agents, Steroids
EUS-FNA With and Without Suction

Study Overview
=================
Brief Summary
-----------------
To compare the number of passes required for cellblock acquisition with and without suction using the 25g needle.

Official Title
-----------------
Randomized Single Blind Controlled Trial of EUS-FNA With and Without Suction for Adequate Cellblock Sample Procurement of Solid Pancreatic Mass Lesions Using 25G Needle

Conditions
-----------------
Solid Pancreatic Mass Lesions

Intervention / Treatment
-----------------
* Procedure: Suction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients referred to UAB Endoscopy Unit for assessment of pancreatic mass lesions that requires FNA. Exclusion Criteria: Age < 19 years Unable to safely undergo EUS for any reason Coagulopathy (INR>1.6, Prothrombin Time>18 secs, Thrombocytopenia < 80,000 cells/ml) Unable to consent Non-English speaking patients

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Suction<br>Suction will be applied to patients undergoing EUS-FNA | Procedure: Suction<br> <br> |
| No Intervention: Without suction<br>No suction will be applied to patients undergoing EUS-FNA | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of passes |  | once at baseline |
Epigenetic Changes in Head and Neck Cancer

Study Overview
=================
Brief Summary
-----------------
With this study, the investigators will investigate the epigenetic changes, which may contribute to the development of head and neck squamous cell carcinomas.

Official Title
-----------------
Biomarkers in Head and Neck Cancer - Epigenetic Changes and Hypermethylation of Promoter-regions

Conditions
-----------------
Head and Neck Cancer, Squamous Cell Carcinoma, Head and Neck Squamous Cell Carcinoma, Head and Neck Neoplasms

Participation Criteria
=================
Eligibility Criteria
-----------------
Cancer group: Inclusion Criteria : Written informed consent Histologically confirmed oral squamous cell carcinoma Exclusion Criteria: History of cancer Uncontrolled comorbidity Control group: Inclusion Criteria : Written informed consent Normal buccal mucosal surface. Normal ENT-examination Exclusion Criteria: History of cancer Uncontrolled comorbidity

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 |
| --- | --- |
| Oral Cancer group<br>20 consecutive patients with oral squamous cell carcinoma referred to the Department of Otolaryngology - Head and Neck Surgery | |
| Healthy oral mucosa group<br>20 controls with normal buccal mucosa upon examination. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Differences in epigenetic changes | Differences between tumor- and healthy group | 6 months |