linjc16/ctgov huggingface dataset:
Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis

Study Overview
=================
Brief Summary
-----------------
To provide TEZ/IVA combination therapy to CF patients who are 12 years of age and older who completed Vertex TEZ/IVA combination therapy clinical studies (NCT02565914 or NCT03150719). To provide TEZ/IVA combination therapy to CF patients in critical need who are 12 years of age and older, homozygous for F508del.

Official Title
-----------------
Tezacaftor/Ivacaftor Combination Therapy Expanded Access Program for Patients 12 Years of Age and Older With Cystic Fibrosis

Conditions
-----------------
Cystic Fibrosis

Intervention / Treatment
-----------------
* Drug: tezacaftor/ivacaftor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and females, 12 years of age and older with confirmed diagnosis of CF. - completed Vertex clinical studies NCT02565914 or NCT03150719, or - are homozygous for F508del and have (1) discontinued Orkambi within 12 weeks from start of treatment because of the onset of respiratory AEs considered to be treatment related or (2) cannot initiate Orkambi because of chronic treatment with an essential sensitive CYP3A substrate or a CYP3A substrate with a narrow therapeutic index AND who meet at least 1 of the following criteria: the highest percent predicted forced expiratory volume in 1 second (ppFEV1) is <40 in the 6 months before the date of completion of the request form, or documentation of being active on a lung transplant waiting list or documentation of being evaluated for lung transplantation, but deemed unsuitable because of contraindications, or rapid and persistent loss of lung function, defined as at least a 20% relative decrease in ppFEV1 in the last 6 months and sustained for at least 1 month despite appropriate treatment. Exclusion Criteria: History of any comorbidity that, in the opinion of the treating physician, might pose undue risk in administering TEZ/IVA combination therapy to the patient (e.g., history of advanced liver disease). Ongoing or prior participation in an investigational drug study (with the exception of Vertex clinical studies evaluating TEZ/IVA) within 5 terminal half-lives of the previous investigational study drug or 30 days, whichever is longer, of first administration of TEZ/IVA. Subjects who are pregnant. Patients eligible for participation in ongoing clinical studies evaluating TEZ/IVA or other CFTR modulator therapies. Other protocol defined Inclusion/Exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: tezacaftor/ivacaftor|orally administered TEZ/IVA combination therapy|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy

Study Overview
=================
Brief Summary
-----------------
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.

Detailed Description
-----------------
ultrasound guided quadratus lumborum will be given for patients under going partial or complete urinary bladder removal.

Official Title
-----------------
Bilateral Quadraus LUMBORUM Block in Patients Under Going Cystectomy

Conditions
-----------------
Pain, Acute

Intervention / Treatment
-----------------
* Procedure: epidural catheter
* Procedure: nerve block catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elective surgery patients between 30 and 60 years Exclusion Criteria: coagulopathy infection at insertion site patient refusal

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: epidural group<br>ULTRASOUND GUIDED thoracic epidural at T 12 WILL BE INSERTED before anaesthesia induction | Procedure: epidural catheter<br>* ultrasound low frequency probe will be used to determine the depth of the posterior complex to assists placement of midline thoracic epidural<br>|
| Active Comparator: quadus lumborum group<br>bilateral ultrasound guided quadratus lumborum catheter will be inserted before anaesthesia induction | Procedure: nerve block catheter<br>* ultrasound guided placement of bilateral quadratus lumborum catheters<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain score | Visual analogue score from 0 to 10 will be used to assess pain postoperative. 0 means no pain. 10 is worst pain | 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anaesthetic consumption | calculating the total anaesthetic MAC consumed | 4 hours | 
| diaphragmatic excursion | assessment of diaphragmatic excursion preoperative and postoperative using low frequency ultrasound probe | 24 hours |
A Study to Investigate the Safety and Effectiveness of Aspheric Laser Refractive Surgery Treatments for Myopia

Study Overview
=================
Brief Summary
-----------------
The objective of this study was to compare the safety and effectiveness of two versions of the Bausch & Lomb Zyoptix Tissue Saving Aspheric Algorithm versus the current Zyoptix Tissue Saving Algorithm when used for myopia and myopic astigmatism LASIK treatment.

Official Title
-----------------
Compare the Safety and Effectiveness of Two Versions of the Bausch & Lomb Zyoptix™ Tissue Saving Aspheric Algorithm to the Current Zyoptix™ Tissue Saving Algorithm When Used for Myopia and Myopic Astigmatism Lasik Treatment

Conditions
-----------------
Myopia, Astigmatism

Intervention / Treatment
-----------------
* Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm
* Device: The Bausch & Lomb Zyoptix Tissue Saving algorithm


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Myopia with or without astigmatism. Normal Corneal topography Willing to have both eyes treated with the laser. Exclusion Criteria: Contraindications to LASIK.

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Zyoptix Tissue Saving Aspheric<br>The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism. | Device: The Bausch & Lomb Zyoptix Tissue Saving Aspheric algorithm<br>* Used with LASIK treatment for the correction of myopia and myopic astigmatism.<br>|
| Active Comparator: Zyoptix Tissue Saving<br>The Bausch & Lomb Zyoptix Tissue Saving algorithm is used for treatment with LASIK for the correction of myopia and myopic astigmatism. | Device: The Bausch & Lomb Zyoptix Tissue Saving algorithm<br>* Used with LASIK treatment for the correction of myopia and myopic astigmatism.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Uncorrected visual acuity |  | At 90 days post surgery | 
| Preservation of best spectacle corrected high contrast logMAR distance visual acuity compared to baseline. |  | At 90 days post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Deviation from target correction |  | At 90 days post surgery | 
| Improvement in uncorrected distance high contrast logMAR visual acuity compared to baseline |  | At 90 days post surgery |
Carrying Angle From Birth to Adolescents

Study Overview
=================
Brief Summary
-----------------
The carrying angle in the elbow in children is very important.Most of the results of treatment in fracture around the elbow have to measure the carrying angle.The common deformity of the elbow from cubitus varus is the change of the carrying of the elbow.There are many researches studied in normal value of the carrying angle but few had study the carrying angle from birth to adolescent.This study want to compare the carrying angle in different age and gain the knowledge of development of the carrying angle in children

Detailed Description
-----------------
The study is to measure the carrying angle of the children from birth to adolescents

Official Title
-----------------
Normal Value of Carrying Angle in the Elbow From Birth to Adolescents

Conditions
-----------------
Birth

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: normal children age 0 day to 16 years old Thai nationality Exclusion Criteria: no history of fracture around the elbow or upper extremity no congenital anomalies or abnormal bone that interfere the upper extremity no genetic diseases and skeletal dysplasia no deformity of the elbow or upper extremity refuse to enrolled in the study

Ages Eligible for Study
-----------------
Minimum Age: 1 Day
Maximum Age: 16 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: no intervention|only measurement of the carrying angle|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| carrying angle | the angle between the arm and forearm in full extension and supination of the elbow | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| age | age count in year | 1 year |
Assiut University Children Hospital Egypt

Study Overview
=================
Brief Summary
-----------------
Frequency and outcomes of mechanical ventilation In intensive care unit at Assiut university children hospital.

Detailed Description
-----------------
Data will be extracted from the files of the patients which will include the following: History Examination Investigations Cause of mechanical ventilation (status epilepticus,respiratory failure and other) First attempt success rate

Official Title
-----------------
Assiut University Children Hospital

Conditions
-----------------
Mechanical Ventilation Outcomes

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are mechanically ventilated age:One month to 18 years. sex:both male and female duration:for one year type of the study:retrospective site :intensive care unit at Assiut university children hospital Exclusion Criteria: patients who are intubated outside Assiut university children hospital.

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum 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 |
| --- | --- | --- |
| Frequency of endotracheal intubation | will be calculated by the following equiation : Number of patient who undergo endotracheal intubation over total number of patient admitted to intensive care unit × 100 . | one year | 
| First attempt success rate | will be calculated by comparing the number of patients on whom ETI was attempted with the times successful tracheal intubation was achieved on a first attempt at laryngoscopy. | one year |
The Influence of Short-term Starvation on Hepatitis B Virus Load

Study Overview
=================
Brief Summary
-----------------
Hepatitis B virus is a small DNA virus that affects 400 million people worldwide. The virus infects the liver and previous studies, done in tissue culture and in animals, have shown that viral replication is affected by metabolic changes occurring in the liver. Specifically, starvation induces HBV gene expression and replication, in parallel to the activation of the gluconeogenesis response, and feeding attenuates viral activity. In this study we are going to recruit HBV patients with detectable viremia and analyze their viral load after an over night starvation versus after a morning meal. Our hypothesis is that following an over-night starvation viral load will be higher than that in the fed state.

Official Title
-----------------
The Influence of Short-term Starvation on Disease Severity and Viral Replication Among Hepatitis B Virus Patients

Conditions
-----------------
Starvation, Infection

Intervention / Treatment
-----------------
* Behavioral: Over night starvation (fasting)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hepatitis B virus patients with detectable viremia >18 years old signed a consent form Exclusion Criteria: patients with malignancy Patients with diabetes mellitus Alcohol consumption of more than 140grams a week Advanced liver disease HCV or HIV infection Pregnancy Mental retardation or unable to understand basic explanation about the study -

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Hepatitis B virus infected patients<br>HBV patients with detectable viremia will be analyzed for their level of viremia following an over-night starvation (fasting) versus fed state | Behavioral: Over night starvation (fasting)<br>* HBV viral load will be analyzed after over-night starvation versus following a morning meal<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A change in the levels of hepatitis B viremia (HBV viral load) between starvation and fed states |  | Following an over-night (8-12hours) starvation versus following a morning meal. 6 visits overall, one visit every 2 weeks (12 weeks over all). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatitis B virus, Metabolovirus
3D CT Guidance for Transjugular Intrahepatic Portosystemic Shunt Creation

Study Overview
=================
Brief Summary
-----------------
To prospectively evaluate the efficacy of real-time 3D CT-image guidance and CO2 portography during transjugular intrahepatic portosystemic shunt (TIPS) creation.

Official Title
-----------------
Guidance for TIPS Creation: CT-image Versus CO2 Portography

Conditions
-----------------
Portal Hypertension

Intervention / Treatment
-----------------
* Device: CT-image guidance
* Drug: CO2 portograms guidance


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis Scheduled for indicated TIPS procedure Exclusion Criteria: Presence of portal vein thrombosis Presence of ascites Presence of hepatic vein occlusion or stenosis Proven malignancy including hepatocellular carcinoma 5. End-stage renal disease under renal replacement therapy; 6. Cardiorespiratory failure 7. Pregnancy or patients not giving informed consent for TIPS procedures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: CT-image guidance<br>Previously acquired portal venous phase of CT datasets and intra-operative CT datasets were registered on a dedicated workstation. The selected volume of interest of the CT-image showing portal vein vasculature was overlaid onto the fluoroscopic display as real-time 3D CT-image guidance during the procedure. | Device: CT-image guidance<br>* TIPS creation is performed under the guidance of 3D CT-image.<br>|
| Active Comparator: CO2 portography<br>two two-dimensional (2D) CO2 portograms | Drug: CO2 portograms guidance<br>* TIPS creation is performed under the guidance of two-dimensional (2D) CO2 portograms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Technical success rate |  | procedure | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Median needle passes for portal vein entry |  | procedure | 
| Median radiographic fluoroscopy time for portal vein entry |  | procedure | 
| The median radiation dose for the whole TIPS procedure |  | procedure | 
| The rate of TIPS complication |  | 6 months |
Circulating Lymphatic Progenitor Cell and Lymph Node Metastasis

Study Overview
=================
Brief Summary
-----------------
Correlation of circulating lymphatic endothelial progenitor cells with lymph node metastasis

Detailed Description
-----------------
Correlation of circulating lymphatic endothelial progenitor cells with lymph node metastasis in ovarian cancer patients

Official Title
-----------------
Correlation of Circulating Lymphatic Progenitor Cells With Lymph Node Metastasis in Ovarian Cancer Patients

Conditions
-----------------
Ovarian Cancer

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ovarian cancer patients diagnosed by pathologic examination Exclusion Criteria: other malignant disease inflammatory disease untreated diabetic and hypertension chronic renal failure rheumatoid arthritis

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 80 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Lymphatic progenitor cell<br>Circulating lymphatic progenitor cell | |
| Control<br>healthy people | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Optical Coherence Tomography Angiography and Pseudophakic Cystoid Edema

Study Overview
=================
Brief Summary
-----------------
This study evaluates the retinal vascular features in macula and papillary regions in patients affected by pseudophakic cystoid edema using optical coherence tomography angiography

Detailed Description
-----------------
Pseudophakic cystoid edema represents one of the most common causes of poor visual outcome following cataratta surgery. It is still source of debate the pathogenesis of Pseudophakic cystoid edema. Optical coherence tomography angiography represents a novel and non-invasive diagnostic technique that allows a detailed analysis of retinal vascular features. The study evaluates retrospectively the changes in optical coherence tomography angiography parameters at baseline and after three monthly after surgery.

Official Title
-----------------
Peripapillary Vascular Density in the Pathogenesis of Pseudophakic Cystoid Edema

Conditions
-----------------
Pseudophakic Cystoid Macular Edema

Intervention / Treatment
-----------------
* Diagnostic Test: OCTA and pseudophakin cystoid edema


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age older than 60 years diagnosis of pseudophakic cystoid macular oedema treatment-naïve for pseudophakic cystoid macular oedema absence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration) Exclusion Criteria: age younger than 60 years No diagnosis of pseudophakic cystoid macular oedema previous treatment for pseudophakic cystoid macular oedema presence of other ocular diseases, responsible for macular edema (retinal vein occlusion, diabetic retinopathy, age-related macular degeneration)

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 80 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 |
| --- | --- |
| Patients group<br>Subjects over 18 years that after cataract surgery, showed pseudophakic cystoid macula edema. | Diagnostic Test: OCTA and pseudophakin cystoid edema<br>* Patients underwent OCT angiografia after cataract surgery<br>|
| Control Group<br>Normal subjects over 18 years that did not show pseudophakic cystoid macula edema. | Diagnostic Test: OCTA and pseudophakin cystoid edema<br>* Patients underwent OCT angiografia after cataract surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| OCTA and pseudophakic cystoid macular oedema | The parameters analyzed by OCTA three months after surgery are: Vessel density (%) of superficial capillary plexus, deep capillary plexus, coriocapillary plexus in macular region Vessel density (%) of radial peripapillary capillary plexus in papilllary region | 3 months |