linjc16/ctgov huggingface dataset:
Bioequivalence Study of Idalopirdine Tablets 60 mg

Study Overview
=================
Brief Summary
-----------------
This study aims to establish bioequivalence between two tablet formulations of idalopirdine

Official Title
-----------------
Interventional, Randomised, Open-label, Two-way Crossover, Single-dose Bioequivalence Study of Idalopirdine in Healthy Subjects Comparing the 60 mg Commercial Tablet (Test) to the 60 mg Clinical Tablet (Reference)

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Idalopirdine 60 mg formulation A (test)
* Drug: Idalopirdine 60 mg formulation B (reference)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy men and women -≥18 and ≤55 years of age body mass index (BMI) of >18.5 and <30 kg/m2 Exclusion Criteria: Pregnant and lactating women Other protocol defined inclusion and exclusion criteria may apply

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 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: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Idalopirdine 60 mg formulation A (test)<br> | Drug: Idalopirdine 60 mg formulation A (test)<br>* Tablet for oral use, single dose<br>* Other names: Lu AE58054;|
| Experimental: Idalopirdine 60 mg formulation B (reference)<br> | Drug: Idalopirdine 60 mg formulation B (reference)<br>* Tablet for oral use, single dose<br>* Other names: Lu AE58054;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the idalopirdine plasma concentration-time curve |  | 0 to 72 hours post-dose | 
| maximum observed concentration (Cmax) of idalopirdine |  | 0 to 72 hours post-dose |
Relationship of SmartPhone Use Addiction With Musculoskeletal System and Cognitive Flexibility

Study Overview
=================
Brief Summary
-----------------
Smartphones have become a part of everyday life, but with some problems. Researches have pointed out that smartphone addiction can cause both physical and mental problems.

Detailed Description
-----------------
Smartphones have become a part of everyday life, but with some problems. Developments in communication technologies have also improved the capacities and limits of smartphones. This has led to the increased availability of smartphones in daily life. Smartphones have become a part of everyday life, but with some problems. Smartphone addiction has been an important topic of research and discussion as a type of addiction that develops depending on the frequency of smartphone use. Researches have pointed out that smartphone addiction can cause both physical and mental problems. As a result of a study conducted in the literature, continuous use of smartphones has been found to cause sleep disturbances, stress, anxiety, decrease in physical activities and many diseases. In this study, the relationship between the concept of smartphone addiction and musculoskeletal problems and cognitive flexibility in young people will be investigated.

Official Title
-----------------
Investigation of the Relationship of Smart Phone Use Addiction With Musculoskeletal System Problems and Cognitive Flexibility

Conditions
-----------------
Smartphone, Musculoskeletal, Cognitive Flexiblity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: University students Without any known physical and/or psychological disorders Using a smartphone Volunteer Exclusion Criteria: Have any physical and/or psychological disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 25 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 |
| --- | --- | --- |
| Smartphone addiction scale score | The Smartphone Addiction Scale (SAS) is a33-item, six-point Likert-type self-rating scale. | at the end of the third month |
The Impact of the SCN9A Gene Polymorphism on Postoperative Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study to determine the association between postoperative pain after cesarean section and several single nucleotide polymorphisms in SCN9A sodium channels gene.

Detailed Description
-----------------
SCN9A gene encodes an alpha subunit of the voltage-gated sodium channel (Nav1.7) and polymorphisms of this gene are associated with severe pain disorders. The impact of the polymorphisms in SCN9A on postoperative pain and opioid consumption after cesarean section is unclear.

Official Title
-----------------
The Impact of the Single Nucleotide Polymorphisms rs6746030,rs7604448, rs10930214, s7595255 in SCN9A Gene on Postoperative Pain and Analgesic Consumption After Cesarean Section

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

Intervention / Treatment
-----------------
* Procedure: cesarean section
* Drug: Opioid Tramadol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The women aged 18 to 45, in 36 to 40 weeks of pregnancy undergoing cesarean section Exclusion Criteria: History of chronic pain or pain disorders Psychiatric diseases Diabetes mellitus Severe cardiovascular, kidney or liver diseases Alcohol or drug abuse Heavy smoker Unable to use the Patient controlled analgesia (PCA) pump

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: cesarean section|Women in 36 to 40 weeks of pregnancy undergoing cesarean section by Pfannenstiel technique|
|Drug: Opioid Tramadol|Tramadol will be administered via patient controlled analgesia (PCA) pump in the postoperative period|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | The pain will be evaluated with the visual analog scale | up to postoperative 24 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Opioid consumption | The total amount of the tramadol administered to the patient will be recorded | Up to postoperative 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
NAV1.7 Voltage-Gated Sodium Channel, pain, postoperative, cesarean section
Sensitivity of Antibiotics for Urinary Tract Infections Patients Attending Family Physicians

Study Overview
=================
Brief Summary
-----------------
This study is aiming to evaluate the sensitivity of uropathogens isolated in patients with community acquired UTI with Enoxacin in comparison to other antimicrobials. While Secondary objective is to study the spectrum of uropathogens responsible for community acquired UTI in local population

Detailed Description
-----------------
Mid stream , clean catch urine specimens of patients with uncomplicated community acquired UTI sent to microbiology labs by treating consultants from filter clinics for evaluation of pathogens will be utilized for sensitivity analysis. Only the first positive urine culture obtained per sample will be included in the analysis to eliminate any possibility of recurrence and nosocomial infection. The polymicrobial cultures and cultures with multidrug-resistant uropathogens will not be included in the analysis. Cultures with common contaminants, including coagulase-negative staphylococci and hemolytic streptococci, and cultures with Candida growth will be excluded. . Data points to be collected will be date of collection, computer generated Lab #, age, gender,list of cultured organisms, sensitivity of organisms with antibiotics.

Official Title
-----------------
Antibiotic Susceptibility of Bacterial Uro-Pathogens In Patients Attending Family Physicians (In Vitro Study)

Conditions
-----------------
Urinary Tract Infections (UTIs)

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Samples from primary care clinics from patients who reports UTI symptoms and in which uropathogens are isolated will be included. Exclusion Criteria: Samples from specialized, hospitalized or catheterized 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 |
| --- | --- |
| Urinary Tract Infections (UTIs)<br>Uncomplicated UTIs | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensitivity of Uropathogens | Sensitivity of identified organisms shall be noted by the zone size in millimeters of the cultured organisms. Sensitive, Intermediate and Resistant labels shall be used as per Clinical Laboratory Standard Institute (CLSI) guidelines. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Common UTI pathogens | To enlist the number and names of identified uropathogens from urine cultures. | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Uncomplicated UTI, Enoxacin
Contact Lens Optics and Visual Performance

Study Overview
=================
Brief Summary
-----------------
This study will evaluate changes in visual performance at different pupil sizes between a single vision soft contact lens and multifocal soft contact lens, and compare refractive error measured between these two lenses with an autorefractor and an aberrometer

Official Title
-----------------
Contact Lens Optics and Visual Performance

Conditions
-----------------
Myopia

Intervention / Treatment
-----------------
* Device: Single vision contact lens
* Device: Multifocal contact lens


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Able to read and understand the informed consent document 18 to 39 years of age (inclusive) Best corrected visual acuity of 20/25 or better in the right eye Refractive error from -1.00D to -8.00D with astigmatism less than or equal to -1.00D in the right eye (corneal plane) Exclusion Criteria: Any ocular or systemic conditions affecting vision, refraction, or the ability to wear a soft contact lens History of ocular trauma or surgery causing abnormal or distorted vision Current Rigid Gas Permeable (RGP) contact lens wearers Pregnant and/or lactating females, by self-report

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 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: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Single vision contact lens<br>Subjects will wear a single vision soft contact lens during the study visit | Device: Single vision contact lens<br>* Subjects will wear a single vision soft contact lens only during the study visit<br>* Other names: comfilcon A;|
| Other: Multifocal contact lens<br>Subjects will wear a multifocal soft contact lens during the study visit | Device: Multifocal contact lens<br>* Subjects will wear a multifocal soft contact lens only during the study visit<br>* Other names: comfilcon A;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual performance | Low contrast visual performance will be measured at different pupil sizes for each subject while wearing each of the two lenses | Through completion of study visit, an average of 3 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Refractive error | Refractive error will be measured with an autorefractor and an aberrometer with subjects wearing each of the two lenses | Through completion of study visit, an average of 3 hours |
An Observational Study of MabThera/Rituxan (Rituximab) in Combination With CHOP Chemotherapy in First-Line in Patients With Diffuse Large B-Cell Lymphoma

Study Overview
=================
Brief Summary
-----------------
This multicenter, observational study will evaluate the correlation between clinical and biological factors and International Prognostic Index (IPI) as prognostic factors in patients with diffuse large B-cell lymphoma receiving first-line treatment with MabThera/Rituxan (rituximab) in combination with CHOP chemotherapy. Eligible patients receiving treatment according to standard of care and local guidelines will be followed for the duration of treatment (approximately 8 months) and during 1 year of follow-up.

Official Title
-----------------
Non-interventional, Post-marketing Study to Evaluate the Correlation Between Clinical and Biological Factors and IPI as Prognostic Factors in Patients With DLBCL in First Line Treatment With R-CHOP

Conditions
-----------------
Diffuse Large B-Cell Lymphoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients, >18 years of age Patients with diagnosed diffuse large B-cell lymphoma in first-line treatment with R-CHOP Exclusion Criteria: Prior chemotherapy treatment for diffuse large B-cell lymphoma Contra-indications or exclusion criteria according to the Summary of Product Characteristics for MabThera/Rituxan

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 |
| --- | --- |
| Cohort<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment patterns in clinical practice: Number of treatment cycles received |  | approximately 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event-free survival |  | approximately 4 years | 
| Response rates |  | approximately 4 years | 
| Safety: Incidence of adverse events |  | approximately 4 years |
Macular Function During Anti-VEGF Treatment

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the changes in macular function during anti-VEGF treatment for neovascular age-related macular degeneration.

Detailed Description
-----------------
Macular function will be investigated using visual acuity, contrast sensitivity, mfERG and microperimetry.

Official Title
-----------------
Study of Macular Function During Anti-VEGF Treatment

Conditions
-----------------
Age Related Macular Degeneration

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Neovascular AMD in first or second eyes angiographic signs of active subfoveal or juxtafoveal choroidal neovascularization (CNV) BCVA ≥35 ETDRS letters Exclusion Criteria: Spherical equivalent ≥ ± 6 D Previous treatments for CNV in the studied eye

Ages Eligible for Study
-----------------
Minimum Age: 50 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 A<br>Patients investigated with mfERG and MP-1 | |
| Group B<br>Patients investigated by Laser Doppler Flowmetry | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| mfERG central ring amplitude density |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean retinal sensitivity (dB) in three concentric rings (4°, 8° & 12°) |  | 12 months | 
| Choroidal blood flow (ChBFlow) at fovea and at optic nerve head |  | 12 months |
Study of Impact of Air vs SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if one of these gaz (air and sulfur hexafluoride) is better than the other in epiretinal membrane peeling surgery. Both are already used for this surgery and this study will tell us if one is better than the other.

Official Title
-----------------
Study of the Impact of Air Versus SF6 20% on Visual Acuity Improvement After Epiretinal Membrane Stripping

Conditions
-----------------
Epiretinal Membrane

Intervention / Treatment
-----------------
* Procedure: Epiretinal membrane peeling with fluid-air exchange
* Procedure: Epiretinal membrane peeling with fluid-SF6 exchange


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of epiretinal membrane with corresponding optical coherence tomography ETDRS visual acuity worse or equal to 20/30 Adult able to give consent Exclusion Criteria: Diagnosis of age-related macular degeneration Opacity blocking the fundus visualisation Presence of active intraocular inflammation Presence of intraocular tumor Presence of retinal detachment

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Air<br>The participant will undergo epiretinal membrane peeling with fluid-air exchange. The remaining of the surgery is the same in all arms. | Procedure: Epiretinal membrane peeling with fluid-air exchange<br>* The intervention starts with a pars plana vitrectomy and then a epiretinal membrane peeling is performed. During the fluid-gaz exchange, the gaz used will be air. The remaining of the intervention is the same between the two arms.<br>|
| Active Comparator: Sulfur hexafluoride (SF6)<br>The participant will undergo epiretinal membrane peeling with fluid-SF6 exchange. The remaining of the surgery will stay the same. | Procedure: Epiretinal membrane peeling with fluid-SF6 exchange<br>* The intervention starts with a pars plana vitrectomy and then a epiretinal membrane peeling is performed. During the fluid-gaz exchange, the gaz used will be SF6 (sulfur hexafluoride). The remaining of the intervention is the same between the two arms.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual acuity |  | 6 months |
Pollutant Altered Allergic Responses

Study Overview
=================
Brief Summary
-----------------
This study is designed to investigate whether exposure to particulate air pollution increases the allergic response to allergens. Research studies suggest that symptoms in individuals with allergies may be aggravated by exposure to particulate air pollution. We sought to experimental determine this by exposing human volunteers to combustion particles, a component of air pollution, and then challenge them with an allergen such as ragweed or oak tree pollen. Using biological tests we can measure whether the allergen response is magnified by prior particulate exposure.

Detailed Description
-----------------
To study whether particulates enhance the allergic response, we chose the upper airway as a model of allergic inflammation and nasal lavage as a non-invasive method for obtaining samples. The nasal cavity is both an excellent model of allergic inflammation and provides an easily accessible site for study. We measured inflammatory cells and cytokines in the nasal lavage fluid. Our specific hypothesis was that particulate exposure prior to allergen challenge would enhance inflammatory cell recruitment and expression of inflammatory cytokines.

Official Title
-----------------
Markers of Pollutant Altered Allergic Responses

Conditions
-----------------
Allergic Rhinitis, Allergy

Participation Criteria
=================
Eligibility Criteria
-----------------
Adult without a history of asthma or respiratory disease.

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?
-----------------
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
-----------------
Allergy, Air pollution, Lung function, Inflammation