linjc16/ctgov huggingface dataset:
Prevalance of non_ Alcoholic Fatty Liver Diseases in Patient With Inflammatory Bowel Diseases Attending Assiut University Hospitals

Study Overview
=================
Brief Summary
-----------------
To assess the prevalance of non_alcoholic fatty liver diseases in inflammatory bowel disease patients and its relation to type of treatment given and disease severity

Detailed Description
-----------------
Inflammatory bowel diseases (IBD) including Crohns disease (CD) and ulcerative colitis (UC) are chronic relapsing disorders that often require long-term therapy and follow up . They are recognized for their complex pathophysiology that involves innate immune system deregulation and altered microbiome in genetically predisposed individuals. Non-alcoholic fatty liver disease (NAFLD) includes a wide spectrum of disorders, ranging from hepatic steatosis (NAFL) to non-alcoholic steatohepatitis (NASH). NAFLD patients are at high risk for liver fibrosis, cirrhosis, and hepatocellular carcinoma (HCC). Also NAFLD is typically associated with altered metabolism and metabolic syndrome (MetS).

Official Title
-----------------
Prevalance of non_ Alcoholic Fatty Liver Diseases in Patient With Inflammatory Bowel Diseases Attending Assiut University Hospitals

Conditions
-----------------
Inflammatory Bowel Disease Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Crohn's disease (CD) patients ulcerative colitis (UC) patients Exclusion Criteria: diabetic patients BMI equal and more than 30.0-34.9(class I obesity)
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 |
| --- | --- | --- |
| the prevalance of non-alcoholic fatty liver in inflammatory bowel disease participants | u/s will be done to all participants of inflammatory bowel disease to asses the rate of non-alcoholic fatty liver affection of all patients | one year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the Correlation between immunosuppressive drugs and prevalance of non-alcoholic fatty liver affection in inflammatory bowel disease participants |  | one year |
Post-Marketing Surveillance of Micombi Tablets Survey on the Long-term Use

Study Overview
=================
Brief Summary
-----------------
The survey is conducted to collect safety and effectiveness information in Hypertensive patients treated with Micombi Tablets on the long term use in daily clinical settings in Japan.

Official Title
-----------------
Post Marketing Surveillance on Long Drug Use of Micombi Combination Tablets in Patients With Hypertension

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

Intervention / Treatment
-----------------
* Drug: Telmisartan 80mg
* Drug: Telmisartan 40mg
* Drug: Hydrochlorothiazide 12.5mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Hypertensive patients who have never taken Micombi Tablets. Exclusion criteria: None
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Micombi® Combination Tablet AP<br> | Drug: Telmisartan 40mg<br>* Combination tablet<br>Drug: Hydrochlorothiazide 12.5mg<br>* Combination tablet<br>|
| Micombi® Combination Tablet BP<br> | Drug: Telmisartan 80mg<br>* Combination tablet<br>Drug: Hydrochlorothiazide 12.5mg<br>* Combination tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Adverse Events (AEs) | The number of patient with any AEs, patients with drug-related AEs | Week 52 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Systolic Blood Pressure (SBP) | SBP is observed at Week 0 and Week 52. The change of SBP from Week 0 to Week 52 is calculated. | Week 0 and Week 52 | 
| Diastolic Blood Pressure (DBP) | DBP is observed at Week 0 and Week 52. The change of DBP from Week 0 to Week 52 is calculated. | Week 0 and Week 52 | 
| Target Blood Pressure Achievement Rate | The proportion of the patients with target blood pressure in 52 weeks administrative period. Target blood pressure is defined as 'Guidelines for the management of hypertension (JSH2009)': less than 140/90 (SBP/DBP) mmHg for >= 65 years old or cerebrovascular disorder patient; less than 130/80 in diabetes, chronic kidney disease or myocardial infarction patient; less than 130/85 mmHg for others patient. | Week 52 | 
| Blood Pressure Normalised Rate | The proportion of the patients with normalized blood pressure in 52 weeks on administrative period. Normalized blood pressure is defined less than 140/90 (SBP/DBP) mmHg according to JSH2009 | Week 52 |
A Randomized Trial of Rosuvastatin in Elective Angioplasty to Prevent Contrast-induced Nephropathy (CLEAR-CIN).

Study Overview
=================
Brief Summary
-----------------
The investigators analyzed the HMG-CoA reductase inhibitor, rosuvastatin, for the prevention of contrast-medium-induced nephropathy in patients undergoing primary angioplasty.

Detailed Description
-----------------
Patients with stable coronary artery disease already taking chronic statin undergoing elective angioplasty are at risk for contrast-medium-induced nephropathy because there are specified risk factors as age more than 75 years, chronic renal insufficiency, diabetes, use of contrast and the lack of effective prophylaxis.

Official Title
-----------------
A Randomized Trial of Rosuvastatin in Elective Percutaneous Coronary Intervention to Prevent Contrast-induced (CLEAR-CIN).

Conditions
-----------------
Nephropathy

Intervention / Treatment
-----------------
* Drug: Rosuvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: chronic statin use positive stress test findings (electrocardiography, nuclear imaging, or stress echocardiography elective angioplasty. Exclusion Criteria: non-statin therapy any presentation of ACS within 24 hours before the time of randomization current use of potent CYP3A4 inhibitors, including azole antifungals, protease inhibitors, macrolide antibiotics, and cyclosporine renal replacement therapy, a history of kidney transplant, pregnant and with renal failure (serum creatinine > 3.0 mg/dl).

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rosuvastatin<br>40 mg of Rosuvastatin up to 6 hours before elective percutaneous coronary intervention. | Drug: Rosuvastatin<br>* 40 mg of rosuvastatin before angioplasty<br>* Other names: Group 1;|
| No Intervention: Control<br>Use of standard therapy in elective angioplasty. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Contrast induce nephropathy defined by serum creatinine increase more than 0.3mg/dl or 50% higher than baseline | Serum creatinine increase more than 0.3mg/dl or 50% higher than baseline | 48 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Composite end-point ( all cause of death; acute renal failure and no-fatal mayocardial infarctio. | Death, myocardial infarction or kidney insufficiency | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Contrast,nephropathy, angioplasty, stable coronary
Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy

Study Overview
=================
Brief Summary
-----------------
We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings will affect postoperative visual outcome.

Detailed Description
-----------------
We evaluate the intraoperative optical coherence tomographic (OCT) images of eyes with idiopathic macular hole (MH) or lamellar macular hole whether the intraoperative OCT findings will affect postoperative visual outcome.

Official Title
-----------------
Evaluation of Retinal Microstructure Detected With Intraoperative Optical Coherence Tomography During Vitrectomy

Conditions
-----------------
Macular Disease

Intervention / Treatment
-----------------
* Procedure: Vitrectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eyes with macular hole or lamellar macular hole - Exclusion Criteria: Eyes with retinal detachment, retinal vascular disease, glaucoma -

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- |
| Eyes with residual fragment<br>The eyes with residual fragments detected with intraoperative optical coherence tomography | Procedure: Vitrectomy<br> <br> |
| Eyes without residual fragment<br>The eyes without residual fragments detected with intraoperative optical coherence tomography | Procedure: Vitrectomy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recovery of microstructure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual improvement |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lamellar macular hole, macular hole
Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study

Study Overview
=================
Brief Summary
-----------------
Although serum alpha-fetoprotein level and abdominal sonography are the main methods to screening hepatocellular carcinoma (HCC) in cirrhotic patients, the adequate time and methods used are not completely well-defined. This study aims to assess the better timing and methods for prospectively screening HCC in patients with cirrhosis

Detailed Description
-----------------
Well-diagnosed consecutive patients with cirrhosis were enrolled through a designed questionnaire to obtain basic information about gender, age, etiology of cirrhosis, conventional liver function tests, serum AFP level, education level, substance use including smoking, alcohol drinking, betel quid chewing, history of familial HCC, etc. Then the patients was followed by periodic abdominal sonography examination and determination of AFP and liver function. If AFP elevated or liver nodule appears, effort to diagnose HCC will be performed.If HCC was performed, the survival will be followed-up. As anti-viral therapy was found to decrease risk for HCC, patients with those therapy will be excluded.

Official Title
-----------------
Early Screening of Hepatocellular Carcinoma in Cirrhotic Patients: a Prospective Study

Conditions
-----------------
Cirrhosis, Hepatocellular Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Image diagnosis or biochemical diagnosis or presence of portal hypertension Exclusion Criteria: Presence of hepatocellular carcinoma
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 |
| --- | --- | --- |
| development of hepatocellular carcinoma | nodule (with or without seum AFP greater than 400 ng/ml) confirmed by biopsy | during observation |
Esophageal Stump Washout

Study Overview
=================
Brief Summary
-----------------
Intraluminally shed viable tumor cells might contribute to local recurrence in cancer of the esophagus and the cardia. The aim of the the study was to establish a method of mechanical lavage of the remaining part of the esophagus and, hence, to reduce the intraluminal cancer cells before doing the esophageal anastomosis.

Detailed Description
-----------------
See study protocol!

Official Title
-----------------
Esophageal Stump Washout Reduces Free Intraluminal Tumor Cells During Resection of Carcinomas of the Esophagus and Cardia

Conditions
-----------------
Esophageal Cancer, Gastrooesophageal Cancer

Intervention / Treatment
-----------------
* Procedure: Esophageal Stump Washout


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed cancer of gastro-esophageal junction with indication for surgery Exclusion Criteria: missing informed consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 95 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 |
| --- | --- |
| Other: prospective cohort study<br> | Procedure: Esophageal Stump Washout<br>* a washout of the closed esophageal stump with Ringer-solution (10 times 30ml) is performed by means of a transorally inserted 24F-Foley catheter. The first, fifth and tenth portion of the lavage fluid are collected and sent to cytological examination<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Presence of intraluminal tumor cells in the remaining oesophageal stump |  | during the operation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cancer, esophagus, gastro-esophegeal junction, tumor seeding, free viable tumor cells, surgery, intraluminal tumor cells, stump washout
MISP 60528 Pneumococcal Vaccination

Study Overview
=================
Brief Summary
-----------------
This study aims to use two different blood tests (ELISA and OPA) to study response to pneumococcal vaccination administered as per standard guidelines in patients who are undergoing workup for heart transplant (whether or not they have undergone LVAD implantation or have undergone heart transplant.

Detailed Description
-----------------
The patients will be receiving vaccination consistent with standard of care guidelines, regardless of study participation. The additional risk of study participation would be the risks associated with venipuncture (injury to vessel or nerve, syncope). Patients will not accrue benefits personally. However, participation will help others by identifying whether current vaccination strategies in this population are adequate.

Official Title
-----------------
Response to Guideline-concordant Pneumococcal Vaccination Strategy in Cardiac Transplant Candidates and Recipients

Conditions
-----------------
Heart Transplant Infection Prevention

Intervention / Treatment
-----------------
* Biological: PCV15


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18 or over Either undergoing evaluation for heart transplant (with or without LVAD receipt), or having received a heart transplant Receiving a dose of PCV15 or PPSV23 (or both sequentially) concordant with AST guidelines Exclusion Criteria: Infants and children under age 18 Subjects without the capacity to consent Pregnancy Already up to date on pneumococcal vaccination or declining vaccination

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| PCV15 only<br>Draw blood for ELISA and OPA, then administer PCV15 | Biological: PCV15<br>* Blood draw after the vaccination<br>* Other names: PCV15 and PPS23;|
| PPS23 only<br>Draw blood for ELISA and OPA, then administer PPS23 | |
| PCV15 and PPS23<br>Draw blood for Administer PPS23 then draw blood again ELISA and OPA, then administer PCV15 | Biological: PCV15<br>* Blood draw after the vaccination<br>* Other names: PCV15 and PPS23;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine response | Antibody levels | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serotype ELISA response | Antibody production to specific serotype | 12 weeks |
Ion Therapy Patient Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is the prospective and standardized data collection of patients treated with ion therapy at MedAustron.

Detailed Description
-----------------
During and up to 10 years after radiation therapy data regarding tumor control and treatment response as well as acute and late toxicities will be collected at regular time intervals. Additionally quality of life and sociodemographic status will be assessed in all study patients and neurocognitive assessment will be performed in patients undergoing ion radiation of the brain.

Official Title
-----------------
A Prospective Registry Study to Record Clinical Results and Side Effects of Ion Beam Therapy at MedAustron

Conditions
-----------------
Ion Beam Radiation Therapy for Tumor Patients

Intervention / Treatment
-----------------
* Radiation: Protons and Carbon Ions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with tumor disease treated with ion beam therapy at MedAustron Signed informed consent form Exclusion Criteria: Comorbidities endangering treatment delivery or study compliance
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ion beam therapy<br>All patients treated with ion beam therapy at MedAustron who consent to the participation in the registry. | Radiation: Protons and Carbon Ions<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Therapy response | Therapy Response according to RECIST Version 1.1 | 10 years | 
| Overall survival |  | 10 years | 
| Progression-free survival |  | 10 years | 
| Local progression-free survival |  | 10 years | 
| Cause-specific survival |  | 10 years | 
| Toxicity according to NCI CTCAE | Acute/late toxicity according to CTCAEv4.03, June 14,2010 | 10 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| EORTC-QLQ-C30 | Patient-reported quality of life | Through study completion, at 3, 5, and 10 years | 
| EORTC-QLQ-BN20 | Patient-reported quality of life for brain cancer patients | Through study completion, at 3, 5, and 10 years | 
| EORTC-QLQ-PR25 | Patient-reported quality of life for prostate cancer patients | Through study completion, at 3, 5, and 10 years | 
| Neurocognitive test battery | Change in cognition from baseline to endpoint as measured by standardized subtests of test battery | Through study completion, at 3, 5, and 10 years |
Rapid Detection of Group B Strep- 35-37 Week Study

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether a rapid bedside diagnosis of Group B Strep growing in the vagina and rectum can be performed with similar success to the routine culture.

Detailed Description
-----------------
Early Onset Group B Strep (GBS) neonatal infections is one of the leading infections in newborns, nearly all of which are acquired by vertical transmission at the time of childbirth. Most cases can be prevented by identifying women who are colonized with GBS in the vaginal-rectal area and giving these colonized women prophylactic antibiotics in labor. About 15 -20% of women are colonized and nearly all of these women are asymptomatic. Because it takes up to 48 hours to obtain culture results, it is currently recommended to perform cultures in the clinic about 3 - 5 weeks prior to their due date and then prophylaxing those women colonized with GBS with antibiotics when they come in to labor. There are several downsides to this strategy. All women who present with preterm labor are treated until culture results become available (overtreatment), women who go into labor while waiting for culture results are all treated (overtreatment), prior studies have shown 33% of women are positive at 35 weeks, but negative at birth (overtreatment) and 10% are negative at 35 weeks and positive at birth (undertreatment), lost or missing culture results (over- or undertreatment). Using microfluidics and fluorescent PCR, a new test can identify GBS reliably in 30 to 45 minutes in vitro. This study proposes to evaluate the clinical performance (sensitivity, specificity, positive and negative predictive value) of the microfluidic rapid GBS technique in selected women presenting at 35 - 37 weeks to antenatal clinics at the University of Michigan compared to standard culture.

Official Title
-----------------
Rapid Detection of Group B Streptococcus Using a Bedside Microfluidics Device: 35-37 Week Study

Conditions
-----------------
Group B Streptococcus Neonatal Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women 18 years of age or older Mentally capable of giving informed consent Presentation for regularly scheduled 35-37 week cultures Exclusion Criteria: Inability to give informed consent Evidence of ruptured membranes by clinical or laboratory criteria Use of any antibiotic within the previous 7 days

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

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

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Streptococcus Group B, Pregnancy