linjc16/ctgov huggingface dataset:
Attitudes and Believes About Vaccinations in a Supportive Care Patient Population

Study Overview
=================
Brief Summary
-----------------
To learn about the attitudes and beliefs towards vaccination both before and after the COVID-19 pandemic in patients who have received supportive care.

Detailed Description
-----------------
Primary Objective: Our primary objective is to assess patient perception of efficacy and safety of vaccinations. Secondary Objectives: To assess demographic predictors of those who would be considered as vaccine hesitant. To assess patient preferred source of recommendations for or against vaccination. To assess the role past side effects or allergic reactions play on patient perception of future vaccines. To assess patient perception of vaccination prior to COVID-19. To assess patient willingness to get the COVID-19 vaccine. To assess patient willingness to get the influenza vaccine.

Official Title
-----------------
Attitudes and Believes About Vaccinations in a Supportive Care Patient Population

Conditions
-----------------
Vaccinations

Intervention / Treatment
-----------------
* Other: patient population


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who are seen as part of a clinic visit with the Supportive Care Clinic at M.D. Anderson Cancer Center, also patients who are being seen by the inpatient Supportive Medicine Consultation Service. Patients who are 18 years of age or older Patients who are able to speak English. Exclusion Criteria: Patients who are unable to sign written consent Patients who are considered delirious at the time of the clinic encounter as defined by a Memorial Delirium Assessment Scale score of 7 or greater. The nursing staff, as a part of the patient intake process and routine care, performs the delirium assessment for clinic patients.

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 |
| --- | --- |
| Supportive care patient population<br>Attitudes and Believes About Vaccinations, questionnaires | Other: patient population<br>* questionnaires, standard of care<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Exploratory survey evaluating the solely patient's opinions and perceptions regarding the safety and efficacy of vaccinations for Parent Attitudes about Childhood Vaccines (PACV-4 scale) with a score of 2 or greater. | We will assess the patient's opinion and perception of the safety of vaccinations based upon a questionnaire and a Likert scale of responses. | through study completion, an average of 1 year |
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the safety and efficacy of the iStent trabecular micro-bypass stent in reducing intraocular pressure (IOP) in refractory open-angle glaucoma subjects.

Detailed Description
-----------------
Glaukos Corporation conducted a clinical research study at multiple (approximately 7) investigational sites within Europe.

Official Title
-----------------
A Study of the Glaukos Trabecular Micro-Bypass Stent in Refractory Open Angle Glaucoma Subjects.

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

Intervention / Treatment
-----------------
* Device: Glaucoma Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary open-angle glaucoma (POAG) Subject on maximally tolerated medical therapy or where noncompliance with medication has been document Subject has failed a conventional glaucoma surgical procedure. (trabeculectomy, Trabeculoplasty(ALT), viscocanalostomy, collagen implant) Exclusion Criteria: Angle closure glaucoma Fellow eye already enrolled

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br> | Device: Glaucoma Surgery<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy |  | 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open angle, Glaucoma, Refractory, Surgery
Megachannel Device for Advanced Colonoscopy

Study Overview
=================
Brief Summary
-----------------
Megachannel is a newly developed colonic access system allowing rapid and multiple passes of the colonoscope to the right colon. The investigators want to conduct a multinational study to evaluate the safety and clinical feasibility of placing a 100 cm Megachannel prototype in the right colon.

Detailed Description
-----------------
Patients scheduled for colonoscopy with suspected right colonic polypoid lesions will be included. The prototype will loaded onto a 160 cm lower GI endoscope and introduced via colonoscopic guidance. Time to cecum, total investigation time, clinical feasibility and complications will be recorded.

Official Title
-----------------
A Novel Endoscopic Device (Megachannel™) For Repeated Right Colonic Access During Colonoscopy

Conditions
-----------------
Multiple Polyps Right Colon, Large Polyp Right Colon, Suspected Polyp Right Colon

Intervention / Treatment
-----------------
* Device: Colonoscopy with Megachannel™ device loaded


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients scheduled for colonoscopy with suspected large or multiple polys in the right colon Exclusion Criteria: previous abdominal surgery history or currently diagnosed intra-abdominal cancer patients presenting with unstable angina drug abusers pregnant women patients with known colonic strictures

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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Megachannel Application<br>Colonoscopy with loaded Megachannel is performed | Device: Colonoscopy with Megachannel™ device loaded<br>* Before colonoscopy, megachannel is loaded on the endoscope, during colonoscopy megachannel will be inserted into the patient via the endoscope placed in the colon<br>* Other names: Megachannel(TM), produced by Minos Medical, Irvine, CA;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and clinical feasibility of performing colonoscopy with megachannel |  | during every single colonoscopy in the study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
colonoscopy, polypectomy, NOTES
Observational Study of Sifrol® in Patients With Primary Restless Legs Syndrome (RLS)

Study Overview
=================
Brief Summary
-----------------
Study to evaluate treatment effect of pramipexole on RLS severity as measured by IRLS, CGI-I and RLS-6 and to evaluate the time needed to reach maintenance dose of Pramipexole (PPX)

Official Title
-----------------
Sifrol® (Pramipexole) Impact on RLS: A 12-weeks Observational Study in Patients With Primary RLS

Conditions
-----------------
Restless Legs Syndrome

Intervention / Treatment
-----------------
* Drug: Pramipexole


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients suffering from primary RLS who are planned to be initiated on treatment with pramipexole as part of the routine care could be included into the study Patients not pre-treated with any dopaminergic agent (de novo patients) or patients pretreated with dopaminergic medication Male or female patients of any age Exclusion Criteria: Treating physicians are asked to consider the regulations described in the Summary of Product Characteristics (SPC) for the treatment with pramipexole
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| RLS patients<br> | Drug: Pramipexole<br> <br> * Other names: Sifrol®;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of RLS symptoms (IRLS) on a 4-point rating scale |  | up to 12 weeks | 
| Assessment of RLS severity on a 6-point rating scale |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Clinical Global Impression Improvement (CGI-I) rated on a 7-point scale |  | up to 12 weeks | 
| Global assessment of efficacy by investigator on a 5-point scale |  | after 12 weeks | 
| Number of patients with adverse events |  | up to 12 weeks | 
| Time to reach maintenance dose of pramipexole |  | up to 12 weeks |
Botulinum Toxin Injection Efficiency

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to examine the effect of the botulinum toxin injection into muscle tone, strength and mobility with and without muscle exercise effect.

Detailed Description
-----------------
The purpose is also to find out patients subjective symptoms between injections. Hypothesis: Efficiency of the botulinum toxin is more powerful with the muscle exercise before injection.

Official Title
-----------------
Effectiveness of Botulinum Toxin Injection After Exercising Splenius Capitis Muscle in Patients With Cervical Dystonia

Conditions
-----------------
Torticollis, Muscle Spasticity

Intervention / Treatment
-----------------
* Other: Resistance training


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of cervical dystonia Spasticity in splenius capitis muscle Regular treatment with botulinum toxin injection Exclusion Criteria: Don't want to take part the Trial Very long distance from home to Jyväskylä Central Hospital

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 80 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>resistance training | Other: Resistance training<br>* Neck muscle trainings effect on botulinum toxin efficiency<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Muscle tone in splenius capitis muscle |  | five months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain in the neck |  | five months | 
| Mobility in the neck |  | five months | 
| Neck muscle strength |  | five months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Torticollis, Botulinum Toxins
Efficacy of Oxygen Therapy Delivered by Systems Using Oxygen-Saving Valves in COPD Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of oxygen therapy delivered by systems using oxygen-saving valves or not (continuous oxygen). We aim to determine if systems using oxygen-saving valves are equally effective as continuous oxygen delivery systems in reducing exercise-induced hypoxemia in patients with COPD.

Conditions
-----------------
LUNG DISEASES, OBSTRUCTIVE

Intervention / Treatment
-----------------
* Device: pulse oxygen supplementation devices
* Device: continuous oxygen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COPD on necessity of long term oxygen therapy Able to give their written consent Exclusion Criteria: Unstable patients with COPD Patients with restrictive respiratory disease Patients with cardiac or neurologic disease contre-indicating the different evaluations

Ages Eligible for Study
-----------------
Minimum Age: 45 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: oxygen-saving valves<br> | Device: pulse oxygen supplementation devices<br>* oxygen therapy delivered by systems using oxygen-saving valves<br>* Other names: pulse group;|
| Active Comparator: continuous oxygen supplementation<br> | Device: continuous oxygen<br>* oxygen therapy delivered by continuous liquid oxygen devices<br>* Other names: continuous group;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| oxygen saturation during 6 minutes walking test |  | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Walking distance during the 6 minutes walking test |  | 1 day | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
COPD - long term oxygenotherapy, COPD patients with respiratory failure
Reoperation Rate Versus Clinical Recurrence After Ventral Hernia Repair

Study Overview
=================
Brief Summary
-----------------
The risk for recurrence after ventral hernia repair is often based on reoperation rates with short follow-up rather than recurrences identified by clinical examinations. The purpose of current study is find the real incidence of recurrences 3 years after ventral hernia repair and to compare with the reoperation rate.

Detailed Description
-----------------
all patients in a restricted area (all patients in the part of Denmark called Zealand) who had a ventral hernia repair in 2007 (appr. 1200 patients). The patients will be sorted by a questionnaire and if the patients are suspicious for recurrence they will be offered a clinical examination.

Official Title
-----------------
Correlation Between Reoperation and Clinical Palpable Recurrence 3 Years After Ventral Hernia Repair

Conditions
-----------------
Ventral Hernia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Primary ventral hernia repair performed in the region of Zealand in Denmark Exclusion Criteria: Patients who died and patients not resident in region Zealand

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical recurrence after ventral hernia repair |  | up to 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| explanations for not having a recurrence repair |  | up to 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ventral hernia, repair, clinical, reoperation
Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration

Study Overview
=================
Brief Summary
-----------------
There have been some studies to compared trans abdominis plane(TAP) block with wound infiltration of local anesthetics in multiport laparoscopic surgery, but there have been no studies in single incision laparoscopic gastrectomy. The purpose of this study was to compare the effect of ultrasonography-guided transverse nerve block and localized anesthesia infiltration in patients with single incision laparoscopic gastrectomy.

Detailed Description
-----------------
Patients were randomly divided into group N(ultrasonography-guided TAP) block and group W( before surgery local anesthetic infiltration at the incision site). We compared the opioid usage, postoperative 6, 24, and 48 hours pain, presence of vomiting, and duration of hospitalization during the operation.

Official Title
-----------------
Analgesic Efficacy of Ultrasound Guided Transversus Abdominis Plane(TAP) Block Versus Local Anesthetic Infiltration in Adult Patients Undergoing Single Incision Laparoscopic Gastrectomy: A Randomized Controlled Trial

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

Intervention / Treatment
-----------------
* Drug: TAP block
* Drug: wound infiltration


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA class I-II Age: >18 Exclusion Criteria: patients of severe kidney & liver dysfunction allergy of local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 19 Years

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: TAP block<br>USG guided TAP block | Drug: TAP block<br>* TAP block: local anesthetics infiltration at trans abdominis plane<br>* Other names: TAP;|
| Active Comparator: wound infiltration<br>local anesthetics infiltration at surgical incision site | Drug: wound infiltration<br>* wound infiltration: local anesthetics infiltration at surgical incision<br>* Other names: Wound;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative pain score | 100 mm scale of visual analogue scale | 4 hours after end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| post operative opioid consumption | total amount of opioid | 4 hours after end of surgery |
Anti-nucleosome B Lymphocytes in Lupus

Study Overview
=================
Brief Summary
-----------------
Lupus disease is characterized by the production of pathogenic autoantibodies, which participate in end-organ damages. The phenotype of B cells producing the pathogenic autoantibodies in lupus patients is today unknown. Antinucleosome antibodies are characteristic of lupus disease.This project proposes to detect antinucleosome B cells in lupus patients and to analyse their phenotype and their frequency.

Official Title
-----------------
Analysis of Frequency and Phenotype of Anti-nucleosome B Lymphocyte in Systemic Lupus

Conditions
-----------------
Systemic Lupus Erythematosus With or Without Clinical Activity

Intervention / Treatment
-----------------
* Other: Venous blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria for SLE patients: SLE patient : diagnostic based on ACR criteria SLE patient producing seric anti-nucleosome antibodies (ELISA) SLEDAI-2K activity score : inferior to 5 for quiescent patients, superior to 8 since at least 2 months for active patients Exclusion criteria for SLE patients: -- Other autoimmune diseases than SLE- Induced lupus Treatment with corticosteroids >10mg/d (prednisone) for quiescent patients Treatment with corticosteroids >20mg/d (prednisone) for active patients Oral immunosuppressive treatment during the last 6 months (methotrexate, azathioprine, ciclosporine, mycophénolate mofétil) for all patients, treatment during the last year with cyclophosphamide or monoclonal antibodies (rituximab, belimumab) for pour quiescent patients Disease which can modify B and T lymphocyte functions: primary immune deficiencies, evolutive infections, chronic viral infection (VIH in particular), chemotherapy or neoplasm antecedent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patient<br> | Other: Venous blood sampling<br> <br> |
| healthy volunteers<br> | Other: Venous blood sampling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| all cause mortality |  | 1 year |