linjc16/ctgov huggingface dataset:
Study of Photodynamic Therapy (PDT) in Patients With Central Serous Chorioretinopathy (CSC)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the safety and efficacy of PDT at 30% verteporfin dose in the treatment of CSC.

Official Title
-----------------
A Randomized, Double-masked, Multicenter, Controlled Study of Photodynamic Therapy in Patients With Central Serous Chorioretinopathy

Conditions
-----------------
Central Serous Chorioretinopathy

Intervention / Treatment
-----------------
* Procedure: PDT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with CSC patients signed the ICF patients with course of CSC less than 6 months patients did not undertake any treatment for CSC Exclusion Criteria: patients with porphyria patients allergic to verteporfin pregnant or nursing women poor patients compliance sever liver dysfunction dioptric media opacities which make it difficult to exam fundus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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 |
| --- | --- |
| Active Comparator: 50% dose PDT<br>patients in this group was given 50% verteporfin dose PDT | Procedure: PDT<br>* 30% or 50% verteporfin dose PDT was given to patients with CSC<br>* Other names: photodynamic therapy;|
| Experimental: 30% dose PDT<br>patients in this group was given 30% verteporfin dose PDT | Procedure: PDT<br>* 30% or 50% verteporfin dose PDT was given to patients with CSC<br>* Other names: photodynamic therapy;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in BCVA |  | 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Leakage at RPE level in FA |  | 1 week | 
| Change from baseline in central retinal thickness |  | 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year | 
| The incidence rate of adverse event |  | 1 week,2 weeks,3 weeks,1 month,3months, 6 months, 1 year |
Thermosoftening of Double-lumen Tube to Reduce Sore Throat

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of double-lumen tube thermosoftening before intubation to reduce postoperative hoarseness and sore throat.

Official Title
-----------------
The Effect of Double-lumen Tube Thermosoftening Before Intubation to Reduce Hoarseness and Sore Throat

Conditions
-----------------
Hoarseness, Sore Throat, Vocal Cord Injuries

Intervention / Treatment
-----------------
* Procedure: non-thermosoftening
* Procedure: thermosoftening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing thoracic surgery that require the placement of left-sided double-lumen tubes Exclusion Criteria: Preoperative hoarseness or sore throat History of upper airway diseases Anticipated difficult airway Anesthesia time longer than 6 hours

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: non-thermosoftening<br>Double-lumen tube is put into a bottle of normal saline at room temperature (25°C) before intubation. | Procedure: non-thermosoftening<br>* Intubation is performed with a double-lumen tube put into normal saline at room temperature.<br>|
| Experimental: thermosoftening<br>Double-lumen tube is put into a bottle of warm normal saline (40°C) before intubation. | Procedure: thermosoftening<br>* Intubation is performed with a double lumen tube put into warm normal saline (40°C).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative hoarseness |  | up to 3 days after surgery | 
| postoperative sore throat |  | up to 3 days after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vocal cord injuries |  | up to 1 day after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
double-lumen tube, intubation, thermosoftening
A Study of Simbrinza™ Therapy in Patients With Open-Angle Glaucoma or Ocular Hypertension

Study Overview
=================
Brief Summary
-----------------
This study is a retrospective chart review to assess the tolerability and efficacy of treatment with Simbrinza™ used for patients with Open-Angle Glaucoma or Ocular Hypertension.

Conditions
-----------------
Open-Angle Glaucoma, Ocular Hypertension

Intervention / Treatment
-----------------
* Other: No Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participants treated with Simbrinza™ for Intra-Ocular Pressure (IOP) lowering in at least one eye Participants who had at least one-follow-up visit with tolerablity and efficacy data after Simbrinza™ treatment initiation. Exclusion criteria: Active ocular disease other than glaucoma or ocular hypertension History of any intraocular surgery or glaucoma laser surgery within 3 months.

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 |
| --- | --- |
| Simbrinza™<br>Patients treated with Simbrinza™ (brinzolamide 1%/brimonidine 0.2%) as standard of care in clinical practice. No study drug is administered in this study. | Other: No Intervention<br>* No study drug is administered in this study.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to first glaucoma therapy escalation occurrence or discontinuation of Simbrinza® |  | 2 Years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The time to first glaucoma therapy escalation occurrence |  | 2 Years | 
| The time(s) to additional glaucoma therapy escalation occurrence(s) |  | 2 Years | 
| Specific AEs and SAEs occurring with a frequency of ≥5% |  | 2 Years |
ROsuvastatin LOading and Clinical Outcomes Trial

Study Overview
=================
Brief Summary
-----------------
The aim of the present study was to evaluate the effect of pre-procedural single high loading dose (40 mg) of rosuvastatin on the primary end-points of all cause mortality and composite of death or myocardial infarction from cardiovascular (CV) causes, target vessel revascularization (TVR), or stroke.

Conditions
-----------------
Atherosclerosis

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: statin-naive patients stable ischemic heart disease de novo lesions appropriate for PCI Exclusion Criteria: current statin use statin allergic patients acute coronary syndromes lesions not appropriate for PCI refusal for participation statin quitting during follow- up

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 |
| --- | --- |
| Active Comparator: Rosuvastatin<br>A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI. | Drug: Rosuvastatin<br>* A 40 mg loading dose of rosuvastatin was administrated 24 h before the PCI.<br>|
| Placebo Comparator: Control<br>A loading dose of placebo was administrated 24 h before the PCI. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause death and composite of death or myocardial infarction from CV causes, TVR, or stroke |  | 4 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause death |  | 4 year | 
| composite of death or myocardial infarction from CV causes, TVR, or stroke |  | 4 year |
Plasma Glucagon-like Peptide-1 Levels and In-hospital Complications in ST-segment Elevation Myocardial Infarction

Study Overview
=================
Brief Summary
-----------------
Glucagon-like peptide-1 (GLP-1), produced mainly in enteroendocrine cells, participates in energy homeostasis and glucose metabolism by regulating islet hormone secretion, gastrointestinal motility, and food intake, making GLP-1 agonist a treatment for diabetes and obesity. Pre-clinical and clinical studies have demonstrated that GLP-1 also has cardio-protection effects. GLP-1 agonists is able to improve markers of cardiac function, reduce myocardial infarct size and post-myocardial infarction remodeling in experimental myocardial infarction. And GLP-1 infusion improved left ventricular function and increases myocardial salvage in patients with acute myocardial infarction (AMI). The investigators' previous study found that GLP-1 analogues attenuated ischemia-reperfusion induced apoptosis of stem- and myocardial microvascular endothelial cells, and liraglutide (a GLP-1 analog) usage during hospital stay can prevent no-reflow and improve heart function in AMI. Therefore, the investigators carried out a cohort study to evaluate the association between plasma GLP-1 and in-hospital complications in patients with ST-segment elevation myocardial infarction.

Official Title
-----------------
Plasma Glucagon-like Peptide-1 Levels Predict In-hospital Complications in ST-segment Elevation Myocardial Infarction

Conditions
-----------------
STEMI - ST Elevation Myocardial Infarction, Glucagon-like Peptide-1, Bleeding, Complications

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a diagnosis of STEMI and needed PCI Exclusion Criteria: patients with cancer patients who used DPP4 inhibitor patients who used GLP1 analogue
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 |
| --- | --- | --- |
| in-hospital complications | defined as acute heart failure, atrial fibrillation, chest pain or re-acute myocardial infarction, complete atrioventricular block, cerebrovascular disease, ventricular fibrillation or ventricular tachycardia | Time Frame: up to 2 week after PCI (until discharge) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| in-hospital major adverse cardiac or cerebrovascular events | the composite of death, nonfatal MI, or stroke | Time Frame: up to 2 week after PCI (until discharge)] | 
| in-hospital major bleeding | defined as absolute hemoglobin drop (baseline to nadir)≥4g/dl, intracranial hemorrhage, retroperitoneal hemorrhage, use of red blood cell transfusion in patients with a baseline hemoglobin ≥9.0 g/dl, and use of red blood cell transfusion among patients with a baseline hemoglobin <9.0 g/dl and a witnessed bleeding event | Time Frame: up to 2 week after PCI (until discharge) |
Understanding Immunity to the Flu Vaccine in COVID-19 Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure immunity to the flu vaccine over time in patients who had COVID-19. Adults who have been diagnosed with COVID-19 as well as controls without COVID-19 will be invited to participate in this study.

Official Title
-----------------
Understanding Immunity to the Flu Vaccine in COVID-19 Patients

Conditions
-----------------
Corona Virus Infection, Flu Vaccine, Immunity

Intervention / Treatment
-----------------
* Biological: Flu shot


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults enrolled in study 55689 (NCT04373148) or the general population Adults diagnosed with severe or moderate COVID-19 at least 2 months prior enrollment Adults without COVID-19 diagnosis for controls Exclusion Criteria: Received the influenza vaccine less than 4 months ago Pregnant or lactating Patients with special risks attendant to venipuncture Use of immunomodulatory medications Immunodeficiency or autoimmune disease

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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 |
| --- | --- |
| COVID-19 participants<br> | Biological: Flu shot<br>* All participants will receive a single shot of the flu vaccine<br>|
| Control participants<br> | Biological: Flu shot<br>* All participants will receive a single shot of the flu vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Testing immunity to the flu vaccine over time |  | 2 months | 
| Testing immunity to the flu vaccine over time |  | 1 month |
Second Forward View Examination of Proximal Colon on Adenoma Detection Rate

Study Overview
=================
Brief Summary
-----------------
This clinical trial is being conducted to assess whether second forward view examination of proximal colon could increase adenoma detection rate of right colon.

Official Title
-----------------
Impact of Second Forward View Examination of Proximal Colon on Adenoma Detection Rate: A Randomized Clinical Trial

Conditions
-----------------
Colon Adenoma

Intervention / Treatment
-----------------
* Procedure: Second Examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all patients undergoing colonoscopy for screening in our hospital Exclusion Criteria: previous history of resection of colon; familial polyposis syndrome inflammatory bowel disease active antiplatelet or anticoagulant therapy prevent polypectomy; pregnancy or lactating women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Second Examination<br>Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is inserted to the cecum and withdrawn to the hepatic flexure again for second examination. | Procedure: Second Examination<br>* The colonoscopy is passed to the cecum and then withdrawn to hepatic flexure. Then, the scopy is inserted to the cecum and withdrawn to hepatic flexure again for second foreard view examination.<br>|
| No Intervention: Traditional Examinaiton<br>Eligible patients who consent to participate undergo planned colonoscopy by endoscopists performing procedures that day per normal standard of care. The colonoscope is passed to the cecum and then withdrawn to the hepatic flexure with washing and aspirating of colonic contents as needed to optimize visualization of colonic mucosa. Then, the colonoscope is withdrawn to the anus directly. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| per-patient detection rate of adenoma of proximal colon | the number of patients with at least one adenoma identified divided by total number of patients completing colonoscopy | 1 day |
An Observational Study of Type 2 Diabetes in Patients Starting on NovoMix® 30 Treatment

Study Overview
=================
Brief Summary
-----------------
This study is conducted in Europe. The aim of this observational study is to evaluate the incidence of serious adverse drug reactions when initiating or switching to insulin therapy with NovoMix® 30 in subjects with type 2 diabetes under normal clinical practice conditions

Official Title
-----------------
An Observational, Prospective Safety Study in Subjects With Type 2 Diabetes Mellitus Starting NovoMix® 30 (Biphasic Insulin Aspart) Treatment

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

Intervention / Treatment
-----------------
* Drug: biphasic insulin aspart 30


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Type 2 diabetes Insulin-naive or previously treated by basal only insulin therapy Exclusion Criteria: Patients who are unlikely to comply with the protocol Pregnancy or breastfeeding or intention of becoming pregnant

Ages Eligible for Study
-----------------
Maximum Age: 99 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 |
| --- | --- |
| A<br> | Drug: biphasic insulin aspart 30<br>* Start dose and frequency as well as dose alterations to be determined by the physician according to normal clinical evaluation<br>* Other names: NovoMix® 30;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of serious adverse drug reactions, including major hypoglycaemic events |  | at 26 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of all hypoglycaemic events |  | at 26 weeks | 
| HbA1c |  | at 12 weeks and 26 weeks | 
| Fasting plasma glucose at visits |  | at 12 weeks and 26 weeks |
Use of Focalin for Fatigue in Sarcoidosis

Study Overview
=================
Brief Summary
-----------------
Patients diagnosed with chronic sarcoidosis with fatigue for more than 6 months. Sarcoidosis and its treatment can greatly affect your quality of life. Many patients suffer from fatigue (feeling tired), lack of focus and concentration, in ability to organize their daily activities, and memory loss. These commonly reported symptoms often get in the way of everyday life.

Detailed Description
-----------------
This is to be a double blind, randomized trial with cross over of 12 patients with chronic sarcoidosis on stable systemic therapy. Patients will be screened for fatigue using a modified SNAP and Facit-F scores. Patients will be in the study for 20 weeks. Objective of study: To determine the effect of dexmethylphenidate hydrochloride, (d-MPH)(Focalin) on fatigue in Sarcoidosis. The is a common complaint in sarcoidosis, related to the chronic inflammatory nature of the disease. It may also related to therapy for the disease.

Official Title
-----------------
Randomized, Double-Blind, Placebo-Controlled Study of Dexmethylphenidate Hydrochloride, (d-MPH) in the Treatment of Fatigue in Sarcoidosis Subjects.

Conditions
-----------------
Sarcoidosis

Intervention / Treatment
-----------------
* Drug: d-methylphenidate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of sarcoidosis using standard criteria Disease for more than one year Complain of fatigue which has been present for more than six months. Over 18 years of age Exclusion Criteria: Pregnancy Change in therapy for sarcoidosis in prior three months history of ventricular arrythmias Patients with a history of anxiety disorder, glaucoma, motor ties or a family history of Tourette's syndrome. Patients who are currently receiving or have received monoamine oxidase inhibitors within 14 days prior to study entry.

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: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: d-methylphenidate|oral dosing for 8 weeks then cross over to placebo in random order|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of fatigue. |  | 30 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of pulmonary status |  | 30 weeks | 
| Safety of treatment |  | 30 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sarcoidosis, Sarcoid