linjc16/ctgov huggingface dataset:
Vitreous Inflammation in Standard and Heavy Silicone Oil

Study Overview
=================
Brief Summary
-----------------
The inflammatory response after prolonged retinal detachment and after vitreoretinal surgery has its apex in the development of PVR that occurs when retinal cells are exposed to the inflammatory milieu in the humor vitreous. This situation is common in complicated retinal detachment, but is amplified after invasive surgery and by the use of intraocular tamponades that float over a subtle film of liquid where the inflammatory cytokines and growth factors reach the critical concentration over the inferior retina. Many authors have noted that the heavy tamponade are more prone to cause intraocular inflammation compared to standard silicone oil, especially if they remain for several months in the eye. The purpose of this study is to measure the vitreous concentration of some of the most important cytokines involved in the inflammatory vitreal response.

Conditions
-----------------
Vitreous Inflammation

Intervention / Treatment
-----------------
* Device: Vitreous Tamponade with Silicone Oil


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient scheduled for vitrectomy Exclusion Criteria: diabetic retinopathy uveitis

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Standard silicone oil<br>after vitreous removal, the vitreous chamber was filled with standard silicone oil (PDMS) | Device: Vitreous Tamponade with Silicone Oil<br> <br> |
| Experimental: Heavy silicone oil<br>after vitreous removal, the vitreous chamber was filled with heavy silicone oil (Densiron 68) | Device: Vitreous Tamponade with Silicone Oil<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vitreous Prostaglandin E2 Levels |  | intraoperarive |
Comparison Amongst Scleral, Corneal and Amniotic Membrane Grafts to Restore Scleral Thinning

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the use of preserved scleral, corneal and amniotic membrane graft for the surgical repair of scleral thinning of different sizes in patients underwent surgery of pterygium with associated beta therapy .

Detailed Description
-----------------
Scleral thinning may occur secondary to different ocular surface conditions, especially in rheumatologic diseases and after surgeries as in pterygium. There are different methods to treat this condition, as to use scleral, corneal and more recently amniotic membrane graft.

Conditions
-----------------
Scleral Thinning

Intervention / Treatment
-----------------
* Procedure: Human Amniotic Membrane Transplantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with corneal scleral defects that have persisted for 1 years or longer, regardless of their cause. These patients will have received corneal-scleral or amniotic membrane transplant in order to correct scleral thinning Patients with history of pterygium surgery associated with beta therapy followed by scleral thinning Exclusion Criteria: Ocular infection Acute ocular inflammatory condition Previous ocular surgery in the eye study Non-controlled systemic disease such as rheumatoid arthritis

Ages Eligible for Study
-----------------
Minimum Age: 40 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Amniotic Membrane Transplantation<br>Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease | Procedure: Human Amniotic Membrane Transplantation<br>* Human Amniotic Membrane Transplantation for The Treatment of Ocular Surface Disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The surgical procedure was randomized in scleral, corneal or amniotic membrane graft. Nine patients underwent surgery with scleral graft that was covered by conjunctival flap; ten with corneal graft and ten with amniotic membrane transplantation. |  | Patients were followed for 180 days. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Amniotic membrane, Cornea, Scleral thinning
Safety and Efficacy of Daily Use of Micamlo® Combination Tablets AP in Patients With Hypertension

Study Overview
=================
Brief Summary
-----------------
Investigation of safety and efficacy of daily use of Micamlo Combination Tablets AP in patients with Hypertension

Official Title
-----------------
Survey on Drug Use of Micamlo Combination Tablets AP in Patients With Hypertension

Conditions
-----------------
Hypertension

Intervention / Treatment
-----------------
* Drug: Micamlo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: - Male and Female patients with hypertension who did not receive of MICAMLO Combination Tablets AP before the start of the study Exclusion criteria: Patients with a history of hypersensitivity to any ingredient of Micamlo Combination Tablets AP and dihydropyridine derivatives Pregnant woman or possibly pregnant woman Patients with extremely poor bile secretion or patients with serious hepatic disorder
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients with hypertension<br> | Drug: Micamlo<br>* Telmisartan plus Amlodipine T40/A5<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Drug-related Adverse Events | Number of patients with drug-related adverse events | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Systolic Blood Pressure (SBP) | Change from baseline in SBP after 1, 2, 3, 6, 12 months | after 1, 2, 3, 6, 12 months | 
| Change From Baseline in Diastolic Blood Pressure (DBP) | Change from baseline in DBP after 1, 2, 3, 6, 12 months | after 1, 2, 3, 6, 12 months | 
| Proportion of Patients Who Achieved the Target BP | Proportion of patients who achieved the target BP after 1, 2, 3, 6, 12 months | after 1, 2, 3, 6, 12 months | 
| Proportion of Patients Who Normalised Their BP | Proportion of patients who normalised their BP after 1, 2, 3, 6, 12 months | after 1, 2, 3, 6, 12 months |
Leukocyte Dysfunction in Diabetic Patients.

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to study impairment of white blood cell function in patients with type II diabetes.

Detailed Description
-----------------
Leucocytes from poorly controlled diabetes exhibit aberrant chemotaxis, increased susceptibility to bacterial infection, leukotriene production, lysosomal enzyme release, proinflammatory cytokine expression and production of reactive oxygen species. Aberrant glucose concentration in diabetics affects functions of peripheral blood system as well as the immune system leading to impaired host defense. Impaired wound healing is a serious complication associated with diabetes. We hypothesized that impairment in leukocyte function results in dysfunctional inflammatory response in diabetic wounds. The proposed studies focus on characterizing mechanisms that will improve our understanding of the dysfunctional inflammatory response resulting in non-healing chronic wounds in diabetics.

Official Title
-----------------
Leukocyte Dysfunction in Diabetic Patients.

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ages 40-60 yrs old clinically diagnosed with Type II Diabetes Adults ages 40-60 yrs old without Diabetes Exclusion Criteria: Unable to provide informed consent Pregnant Females Therapeutically Immuno-compromised

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum Age: 60 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 |
| --- | --- |
| Normoglycemic<br>Healthy subjects that do not have diabetes | |
| Type II Diabetes (HbA1c <7 or 7%)<br>Subject that have Type II Diabetes with good glucose control with glycated hemoglobin (HbA1c <7 or 7%) | |
| Type II Diabetes (HbA1c between 7.1-9)<br>Subjects with Type II Diabetes with moderate glucose control (HbA1c between 7.1-9) | |
| Type II Diabetes (HbA1c >9%)<br>Subjects with Type II Diabetes with poor glucose control (HbA1c >9%) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ex vivo leukocyte function by measuring ROS production | After blood draw monocytes are separated from whole blood and production of oxidants by these cells | immediately after blood draw | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ex vivo NADPH oxidase gene and protein expression | Gene and protein expressions are measured using Western blot and real time PCR. | After blood draw |
Molecular Genetic Studies of Childhood Brain Tumors and Blood Samples

Study Overview
=================
Brief Summary
-----------------
To look for patterns of polymorphisms in DNA repair in both germline and tumor cells samples.

Official Title
-----------------
Molecular Genetic Studies of Childhood Brain Tumors and Blood Samples

Conditions
-----------------
Brain Cancer

Intervention / Treatment
-----------------
* Procedure: phlebotomy
* Procedure: biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Pediatric cancer patients diagnosed with brain tumors

Ages Eligible for Study
-----------------
Maximum Age: 24 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: phlebotomy|nan|
|Procedure: biopsy|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Follow up of Moderate Aortic Regurge After Mitral Valve Replacement

Study Overview
=================
Brief Summary
-----------------
Aim of the study is to follow of of moderate aortic regurge after mitral valve replacement to figure out if the aortic regurge has been improved or it is getting worse

Detailed Description
-----------------
A considerable proportion of patients who require mitral valve replacement present with a coexisting pathology of the aortic valve (AV). Rheumatic fever remains the leading cause for combined disease (1) Early series found that one-third of rheumatic hearts exhibited involvement of both mitral and aortic valve. The rate increased to 99% when the follow-up period was extended to 20 years The treatment of choice in cases in which one of the valves is moderately affected is questionable. Because combined aortic and mitral valve replacement is usually associated with higher risk and poorer long-term survival than replacement of either of the two valves alone (2) In patients with moderate aortic regurgitation who undergo mitral valve surgery). according to 2021 ESC/EACTS Guidelines, the decision to treat the aortic valve is controversial, as data show that progression of moderate aortic regurgitation is very slow in patients without aortic dilation (3) in contrast , In 2020 AHA guidelines recommended concomitant aortic valve replacement for moderate aortic regurgitation in patients undergoing surgery for ascending aorta, coronary artery bypass grafting (CABG),or mitral valve surgery (4-10) Because of this is a point of conflict we aim in this study to evaluate the saftey to leave moderate aortic regurge without intertvention as regarding operative time ,postoperative morbidity and mortality and progression of aortic valve regurge.

Official Title
-----------------
Follow up of Moderate Aortic Regurge After Rhumatic Mitral Valve Replacement

Conditions
-----------------
Follow up of Moderate Aortic Regurge After Rheumatic Mitral Valve Replacement

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients underwent mitral valve replacement for rheumatic heart disease and having moderate aortic valve regurge GRADE 2 in assuit university hospitals Exclusion Criteria: non rhumatic heart disease ,severe aortic regurge ,moderately severe aortic regurge ,combined ischmic and valvular heart diseaese
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 |
| --- | --- | --- |
| Comparison between pre operative degree of aortic regurge and Postoperative degree of aortic regurge after rheumatic mitral valve replacement |  | 2 years |
the Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

Study Overview
=================
Brief Summary
-----------------
This study assess the safety, tolerability, and efficacy in reducing viral load and proviral DNA of UB-421 administered as an add-on to the ART in ART-experienced viremic HIV-1 subjects.

Official Title
-----------------
A Phase II, Open-label, Controlled, Proof-of-concept Study to Evaluate the Safety of UB-421 in Combination With Antiretroviral Therapy (ART) and the Efficacy in Reduction of HIV Viral Load and Proviral DNA as Compared to ART Alone in ART-experienced Viremic HIV-1 Patients

Conditions
-----------------
HIV-1 Infection

Intervention / Treatment
-----------------
* Biological: UB-421
* Other: Antiretroviral Therapy (ART)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 seropositive Male with body weight ≥ 50 kg or female with body weight ≥ 45 kg. have been receiving antiretroviral therapy (ART) for more than 2 years Exclusion Criteria: Any previous exposure to a mAb within 12 weeks prior to the first dose of UB-421 treatment. Any significant diseases (other than HIV-1 infection) or clinically significant findings, including psychiatric and behavioral problems, determined during the screening period, medical history, and/or physical examination that, in Investigator's opinion, would preclude the subject from participating in this study. History of anaphylaxis to monoclonal antibodies. Any vaccination within 8 weeks prior to the first dose of UB-421.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 100 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Arm1 (Standard ART)<br>Standard ART | Other: Antiretroviral Therapy (ART)<br>* Standard ART<br>|
| Experimental: Arm 2 (ART plus UB-421)<br>ART plus weekly UB-421 IV infusion at 5 mg/kg dose level for 16 weeks | Biological: UB-421<br>* Monoclonal antibody by IV infusion plus standard ART<br>Other: Antiretroviral Therapy (ART)<br>* Standard ART<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| treatment related TEAEs | the incidence of Grade 3 drug-related treatment-emergent adverse events | 16 Weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, UB-421
Neuronal Effects of Exercise in Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This study plans to learn more about how common drugs prescribed to individuals with schizophrenia contribute to weight gain, as well as how exercise and diet impact appetite and the brain's response to food. In this study, the investigators will be evaluating how participants' brains respond to food images as well as asking questions about their food preferences and intake and clinical symptoms. The investigators may also ask participants to complete an exercise or diet intervention to see how this changes brain responses or food preferences.

Official Title
-----------------
Neuronal Effects of Exercise in Schizophrenia

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Behavioral: Exercise
* Behavioral: Diet


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of schizophrenia or schizoaffective disorder Between 21 and 70 years of age Currently prescribed either olanzapine, risperidone, clozapine, or haloperidol, OR not currently being treated with any neuroleptic medications Weight stable within 5 percent for the last 6 months Exclusion Criteria: Pregnancy Substance abuse Significant endocrine/metabolic disease (e.g., uncontrolled hypertension, severe hypertriglyceridemia) MRI-specific exclusion criteria (e.g., claustrophobia, metal in the body)

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 70 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Exercise intervention<br>10 weeks of a moderate exercise intervention | Behavioral: Exercise<br> <br> |
| Active Comparator: Diet intervention<br>10 weeks of a diet intervention | Behavioral: Diet<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neuronal response to visual food cues | Neuronal response (insula) while viewing visual food cues | 14 weeks | 
| Resting-state neuronal response | Neuronal response (default mode network) during rest | 14 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appetite Rating on a visual analogue scale (VAS) | Participants will be asked to rate their hunger via Hunger ratings on a VAS | 14 weeks | 
| Fasting leptin | Fasting blood levels of leptin | 14 weeks | 
| Fasting ghrelin | Fasting blood levels of ghrelin | 14 weeks |
The Continuing Care Needs in Colorectal Cancer Patients in Different Stages

Study Overview
=================
Brief Summary
-----------------
The aims of this study are to: explore supportive care needs in colorectal cancer patients with treatment and survivors; compare the supportive care needs in different stage of colorectal cancer; identify the significant factors for the supportive care needs; explore the supportive care needs within one year after newly diagnosis.

Detailed Description
-----------------
Both large scale cross-sectional survey and a prospective 1-year longitudinal panel study design will be used in this study. The cross-sectional survey is to examine the current status of supportive care needs perceived by different stage of colorectal cancer inpatients and outpatients including survivors. The 1-year longitudinal design is to explore the change of supportive care needs perceived by patients within one year after newly diagnosed with colorectal cancer.

Official Title
-----------------
The Continuing Care Needs From Receiving Treatment to Survival in Colorectal Cancer Patients in Different Stages

Conditions
-----------------
Colorectal Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with colorectal cancer in any stage or survivors Those who are willing to participate in the research Aged above 18 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with colorectal cancer<br>patients with colorectal cancer in any stage or survivors | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| supportive cancer care needs |  | For 1-year follow-up study, measurement time-points include 1, 3, 6, 9, and 12 months after diagnosis. | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colorectal cancer, needs, survivors, any stage
A Phase III Study of Entecavir vs Lamivudine in Adults With Chronic Hepatitis B Infection and Positive for Hepatitis B E Antigen

Study Overview
=================
Brief Summary
-----------------
The purpose of this clinical research study is to assess the safety effectiveness of entecavir, as compared to lamivudine, in the treatment of adults with chronic hepatitis B infection who are hepatitis B e antigen positive.

Conditions
-----------------
Chronic Hepatitis B

Intervention / Treatment
-----------------
* Drug: Entecavir


Participation Criteria
=================
Eligibility Criteria
-----------------
Male and female subjects =/> 16 years of age (or minimum age required in a given country) with history of chronic hepatitis B infection; Documentation of positive Hepatitis B e antigen (HBeAg) status.; The absence of coinfection with immunodeficiency virus (HIV), hepatitis C virus (HCV) or hepatitis D virus (HDV); The absence of other forms of liver disease e.g., alcoholic, autoimmune, biliary disease; Less than 12 weeks prior therapy with nucleoside or nucleotide analogue antiviral agents with activity against hepatitis B (e.g., adefovir, famciclovir and lamivudine)

Ages Eligible for Study
-----------------
Minimum Age: 16 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Entecavir|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |