linjc16/ctgov huggingface dataset:
Loco-regional Analgesia for Post-operative Pain Management in Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to evaluate whether loco-regional analgesia reduces post operative pain compared to intravenous analgesia, in patients undergoing cardiac surgery in minithoracotomy. All patients will be randomized to receive locoregional analgesia (treatment group) or intravenous analgesia (control group), at the end of the cardiac intervention.

Official Title
-----------------
Phase 3 Study of Post-operative Pain Management With Loco-regional Analgesia in Minithoracotomy for Cardiac Surgery. A Randomized Controlled Trial

Conditions
-----------------
Pain, Postoperative

Intervention / Treatment
-----------------
* Device: Loco-regional catheter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients undergoing minithoracotomy for cardiac surgery, > 18 years old Exclusion Criteria: psychiatric diseases, which might limit pain evaluation; urgent surgery; patients on ECMO; lack of consent

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: Loco-regional catheter<br>A suprafascial catheter will be positioned at the end of cardiac intervention during the thoracotomy closure. The catheter will be connected to a elastomeric pump, which delivers the analgesic drug (ropivacaine). | Device: Loco-regional catheter<br>* it is an intra-fascial catheter for realing of the drug locally<br>|
| No Intervention: Intravenous analgesia<br>At the end of the cardiac intervention each patient will receive intravenous analgesia with morphine at 0.8 mg/h. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU lenght of stay and hospital stay |  | 28 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mechanical ventilation in the post-operative period |  | 72 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-operative pain, loco-regional analgesia, minimally invasive surgery
Safety and Immunogenicity of a Melan-A VLP Vaccine in Early Stage Melanoma Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to monitor a specific cellular immune response in melanoma patients at an early stage of the disease, that have been vaccinated with a Melan-A VLP vaccine.

Official Title
-----------------
A Phase IIa Study to Evaluate Safety, Tolerability, and Immunogenicity of a Melan-A VLP Vaccine in HLA-A2 Positive Patients With Stage II Malignant Melanoma

Conditions
-----------------
Malignant Melanoma

Intervention / Treatment
-----------------
* Biological: CYT004-MelQbG10


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to provide written informed consent Able and willing to complete all protocol requirements Age: 18 years and older Histological confirmed stage II melanoma HLA-A*0201 haplotype Expected survival of at least 6 months ECOG performance status of 0 or 1 Full recovery from surgery Adequate organ and bone marrow functions Sexually active males should use adequate contraception throughout the study period and 3 months thereafter. Females of child bearing potential should use adequate contraception throughout the study period and 3 months thereafter, that can be oral contraception or a double-barrier local contraception (intra-uterine device plus condom or spermicidal gel plus condom), and have a negative serum pregnancy test within 4 weeks prior to the first dose of the vaccine. Exclusion Criteria: Pregnant or nursing Use of an investigational drug within 30 days before enrolment Active malignancy in the 5 years prior to enrollment other than melanoma, basal cell carcinoma or cervical carcinoma in situ. Major surgery within 4 weeks prior to enrollment. Current use of an immunosuppressive drug or any concomitant medication that could potentially interfere with the study drug (e.g. steroids, antihistamine drugs; topical or inhalational steroids are permitted). Presence of significant cardiovascular, renal, pulmonary, endocrine, infectious, or neurological disorders. Serum tests positive for HIV, HBV, HCV. Active autoimmune diseases or severe allergies. Current diagnosis or history of relevant and severe psychiatric disorder that compromises the patient's ability to understand the patient information, to give informed consent, to comply with the trial protocol or to complete the study. Blood donation or loss of > 500mL within 8 weeks prior to inclusion. Abuse of alcohol or other recreational drugs. Previous vaccination with a Melan-A analog peptide.

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

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

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

Design Details

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: CYT004-MelQbG10|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Study of Tumor Samples in Patients Undergoing Treatment for Gastrointestinal Stromal Tumors on Clinical Trial ACOSOG-Z9001

Study Overview
=================
Brief Summary
-----------------
RATIONALE: Studying the genes expressed in samples of tumor tissue from patients with cancer may help doctors identify biomarkers related to cancer. PURPOSE: This research study is looking at tumor samples in patients undergoing treatment for gastrointestinal stromal tumors on clinical trial ACOSOG-Z9001.

Detailed Description
-----------------
OBJECTIVES: Primary To examine polymorphisms in selected genes involved in the detoxifying/metabolizing and DNA repair pathways in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from patients with gastrointestinal tumors (GIST) undergoing treatment on clinical trial ACOSOG-Z9001. Secondary To examine approximately 758 polymorphisms among candidate genes involved in detoxification/metabolism, cell cycle control, and DNA damage/repair in relation to specific mutations and types of mutation in the c-kit gene in tumor tissue from GIST patients for hypothesis generation. (exploratory) To conduct an exploratory analysis of the polymorphism distribution in these patients. (exploratory) To examine the association between the above polymorphisms and major toxicity (Grade 3/4) of adjuvant imatinib mesylate. (exploratory) OUTLINE: Tumor samples are used for polymorphism and mutation analysis.

Official Title
-----------------
Genetic Risk Factors for Gastrointestinal Stromal Tumors (GIST)

Conditions
-----------------
Gastrointestinal Stromal Tumor

Intervention / Treatment
-----------------
* Genetic: mutation analysis
* Genetic: polymorphism analysis
* Other: laboratory biomarker analysis


Participation Criteria
=================
Eligibility Criteria
-----------------
DISEASE CHARACTERISTICS: Tumor samples from patients with gastrointestinal stromal tumors enrolled on clinical trial ACOSOG-Z9001

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 |
| --- | --- |
| Group 1<br>Tumor samples are used for polymorphism and mutation analysis. | Genetic: mutation analysis<br> <br> Genetic: polymorphism analysis<br> <br> Other: laboratory biomarker analysis<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| response |  | Up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gastrointestinal stromal tumor
CRTd Responders Optimization

Study Overview
=================
Brief Summary
-----------------
Suboptimal optimization of atrio-ventricular (AV) and inter-ventricular (VV) timings could affect the clinical response of CRTd in T2DM patients. Thus, authors hypothesize that automatic sensor guided CRTd optimization could ameliorate clinical outcomes in patients with T2DM. However, authors will evaluate the effects of cardiac resynchronization therapy (CRTd) in patients with type 2 diabetes mellitus (T2DM) optimized via automatic vs. echocardiographic guided approach.Authors will conduct a prospective, multicenter study to recruit, from October 2016 to June 2019, patients with T2DM and heart failure (HF) candidate to receive a CRTd. After CRTd the patients will be optimized via automatic vs. echocardiographic guided approach.

Official Title
-----------------
Optimization of Cardiac Resynchronization Therapy and Its Effects in Patients With Type 2 Diabetes Mellitus: Automatic Optimization vs. Echocardiographic Guided Optimization.

Conditions
-----------------
Heart Failure, Heart Failure With Reduced Ejection Fraction, Cardiac Death

Intervention / Treatment
-----------------
* Other: echocardiographic optimization of CRTd


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: heart failure with reduced cardiac pump, NYHA class II/III, indication to receive a CRTd. Exclusion Criteria: NYHA class IV, previous CRTD implantation, neoplastic disease, inflammatory chronic disease.

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T2DM patients with CRTd with automatic optimization<br>In this cohort the T2DM patients with CRTd will receive at follow-up an automatic optimization of CRTd. | |
| T2DM patients with CRTd with echocardiographic optimization<br>In this cohort the T2DM patients with CRTd will receive at follow-up an echocardiography guided optimization of CRTd. | Other: echocardiographic optimization of CRTd<br>* the patients after the implant of CRTd and during the follow-up will receive an echocardiography to optimize the atrio-ventricular and inter-ventricular delay, and to improve the effects of CRTd.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CRTd responders rate | The authors will evaluate the CRTd responders rate in terms of patients that will experience the reduction of NYHA class, improvement of HF symptoms, and improvement of left ventricle ejection fraction. | 12 months |
A Multi-Dose Study With a Treatment for Open-Angle Glaucoma

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether Anecortave Acetate is effective for lowering intraocular pressure caused by open-angle glaucoma.

Conditions
-----------------
Open-Angle Glaucoma

Intervention / Treatment
-----------------
* Drug: Anecortave Acetate
* Drug: Anecortave Acetate
* Drug: Anecortave Acetate
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients at least 18 years old with a clinical diagnosis of Open-Angle Glaucoma for at least 6 months and currently treated with a monotherapy hypotensive medication Exclusion Criteria: Prior angle surgery in the study eye, severe visual field loss in either eye, and any other form of glaucoma besides open-angle glaucoma

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 |
| --- | --- |
| Placebo Comparator: 1<br>Placebo treatment with vehicle | Drug: Placebo<br>* Placebo treatment with vehicle<br>|
| Experimental: 2<br>Low dose of study medication | Drug: Anecortave Acetate<br>* Low dose Sustained release depot suspension<br>|
| Experimental: 3<br>Middle dose of study medication | Drug: Anecortave Acetate<br>* Middle dose Sustained release depot suspension<br>|
| Experimental: 4<br>High dose of study medication | Drug: Anecortave Acetate<br>* High dose Sustained release depot suspension<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Intraocular Pressure |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of patients with therapeutic benefit, number and percent of treatment failure and time to treatment failure |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open-Angle Glaucoma, Intraocular Pressure, Anecortave Acetate
Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily for Trial Without Catheter in Acute Urinary Retention With Long Term Follow up

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to compare two alpha blockers, terazosin and doxazosin GITS, in achieving a successful TWOC after AUR due to BPH, among Chinese males in Hong Kong, and in delaying or avoiding a TURP.

Official Title
-----------------
Randomized Trial Comparing Terazosin 5 mg Daily and Doxazosin GITS 4 mg Daily in the Successful Rate of Trial Without Catheter in Acute Urinary Retention With Long Term Follow up

Conditions
-----------------
Prostatic Hyperplasia, Urinary Retention

Intervention / Treatment
-----------------
* Drug: Doxazosin GITS (Cardura XL)
* Drug: Terazosin (Hytrin)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 50 or above Admitted for AUR due to BPH with PVR of 500 ml or more Exclusion Criteria: Previous history of TURP Use of alpha blockers within recent 8 months Renal impairment (serum creatinine >140 umol/l) Poor premorbid state

Ages Eligible for Study
-----------------
Minimum Age: 50 Years

Sexes Eligible for Study
-----------------
Male

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Doxazosin GITS (Cardura XL)|nan|
|Drug: Terazosin (Hytrin)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Successful rate of Trial Without Catheter (TWOC) at phase 1 |  | At discharge after TWOC (at the end phase one) | 
| Late failure of TWOC of, which is defined as recurrent of AUR or the need of invasive therapy among those who are successful in TWOC in phase 1 |  | From the end of phase one to eight months after successful TWOC (the end of phase 2) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with hypotension or symptoms related to hypotension after administration of treatment drug for TWOC |  | From the time of treatment drug administration to the end of phase 1 | 
| Peak flow rate (Qmax), voided volume (Vcomp) and post-voided residue volume (PVR) |  | At the end of phase I (discharge after TWOC) and at the end of phase 2 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Benign Prostatic Hyperplasia (BPH), Acute Retention of Urine (AUR)
Effects of Different Area of Internal Limiting Membrane Peeling (ILM) Peeling on Anatomical Outcomes in Macular Hole Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effects of two different internal limiting membrane (ILM) peeling area on anatomical closure outcomes after macular hole surgery measured by optical coherence tomography (OCT).

Official Title
-----------------
A Randomized, Comparative, Prospective Study of Anatomical Outcomes With Different Internal Limiting Membrane Peeling Area in Surgery for Idiopathic Macular Hole

Conditions
-----------------
Macular Hole

Intervention / Treatment
-----------------
* Procedure: ILM peeling surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with IMH patients signed the informed consent form (ICF) patients with course of IMH less than 3 years Exclusion Criteria: patients with hyper myopia patients with traumatic macular hole accompanied or secondary of other fundus disease open or reopen after receiving MH surgery patients with retinal detachment received vitrectomy due to other diseases glaucoma cannot be controled by medication patients with other retinal or choroidal disease that may affect VA poor patients compliance poor condition that cannot undertake the surgery dioptric media opacities which make it difficult to exam fundus or measure on OCT

Ages Eligible for Study
-----------------
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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 4PD diameter of ILM peeling in surgery<br>patients in this group was given 4papillary diameter (PD) diameter of internal limiting membrane (ILM) peeling in surgery | Procedure: ILM peeling surgery<br>* 4PD or 2PD diameter of ILM peeling in surgery was given to patients with idiopathic macular hole (IMH)<br>|
| Experimental: 2PD diameter of ILM peeling in surgery<br>patients in this group was given 2PD diameter of ILM peeling in surgery | Procedure: ILM peeling surgery<br>* 4PD or 2PD diameter of ILM peeling in surgery was given to patients with idiopathic macular hole (IMH)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anatomical closure grades in OCT |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of anatomical closure grades in OCT |  | 3 months, 6 months, 1 year | 
| Change from baseline in BCVA (best corrected visual acuity) |  | 3 months, 6 months, 1 year |
Comparison of Videolaryngoscopy and Direct Laryngoscopy in Pediatric Airway Management

Study Overview
=================
Brief Summary
-----------------
The investigators intended to evaluate first success rate and learning curve of trainee anesthetists performing direct and videolaryngoscopy in pediatric airway management.

Detailed Description
-----------------
After obtaining written informed consent of 10 trainee anesthetists with non less than 24 months and not exceeding 60 months residency, use of the King Vision aBlade videolaryngoscope was demonstrated by presenting a 2 min instruction video. First endotracheal intubation by each trainee anesthetist was randomly allocated to either direct (DL) or King Vision aBlade videolaryngoscopy (KingVL). Then order of laryngoscopy type was alternating at least each trainee anesthetists performed 10 DL and 10 KingVL endotracheal intubations.

Official Title
-----------------
A Comparison of Direct Laryngoscopy and King Vision® aBlade™ Videolaryngoscopy in Paediatric Airway Management: Success Rate and Learning Curve of Trainee Anaesthetists

Conditions
-----------------
Airway Management, Videolaryngoscopy

Intervention / Treatment
-----------------
* Device: King Vision aBlade
* Device: direct laryngoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA 1 to 2 written informed consent from both legal guardians children who were scheduled for nonemergency surgery with requirement of endotracheal intubation Exclusion Criteria: known or predicted difficult airway increased risk for pulmonary aspiration

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: videolaryngoscopy<br> | Device: King Vision aBlade<br>* endotracheal intubation performed with King Vision aBlade<br>|
| Experimental: direct laryngoscopy<br> | Device: direct laryngoscopy<br>* endotracheal intubation performed with direct laryngoscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first attempt success rate of endotracheal intubation | yes/no | operation day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| total time for successful intubation | in sec | operation day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric airway management, learning curve