linjc16/ctgov huggingface dataset:
Effect of Liraglutide on Blood Glucose Control in Subjects With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
This trial is conducted in Africa, Asia, Europe and South America. This trial is designed to show the effect of treatment with liraglutide added to existing glimepiride and metformin combination therapy and to compare it with the effects of insulin glargine added to combination therapy of glimepiride and metformin.

Official Title
-----------------
Liraglutide Effect and Action in Diabetes (LEAD-5): Effect on Glycaemic Control After Once Daily Administration of Liraglutide in Combination With Glimepiride and Metformin Versus Glimepiride and Metformin Combination Therapy, and Versus Insulin Glargine Added to Glimepiride and Metformin Combination Therapy in Subjects With Type 2 Diabetes.A Six-month Randomised, Double-blind, Parallel-group, Multi-centre, Multi-national Trial With an Open-label Treat-to-target Insulin Glargine Control Arm.

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

Intervention / Treatment
-----------------
* Drug: liraglutide
* Drug: insulin glargine
* Drug: metformin
* Drug: glimepiride


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 diabetes Treatment with oral anti-diabetic drugs for at least 3 months HbA1c: 7.5-10.0 % (both incl.) in subjects on OAD monotherapy. 7.0-10.0 % (both incl.) in subjects on OAD combination therapy. Body Mass Index (BMI) less than or equal to 45 kg/m2 Exclusion Criteria: Treatment with insulin within the last 3 months Treatment with any drug that could interfere with the glucose level Any serious medical condition Females who are pregnant, have intention of becoming pregnant or are breastfeeding

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: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: liraglutide|nan|
|Drug: insulin glargine|nan|
|Drug: metformin|nan|
|Drug: glimepiride|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c |  | after 26 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| body weight |  |  | 
| Safety and tolerability |  |  | 
| Beta-cell function |  |  | 
| Glycaemic control |  |  |
Intraocular Pressure (IOP) Changes Associated With Muslim Prayer Postural Changes

Study Overview
=================
Brief Summary
-----------------
Elevated intraocular pressure is widely accepted as a risk factor for glaucoma and controlling the pressure remains the cornerstone of effective treatment. There is evidence that posture can have a significant effect on intraocular pressure fluctuations. Salat (or Salah) refers to the five daily prayers performed by Muslims. The time spent praying in a kneeling or prostrate position may be associated with wide fluctuations in intraocular pressure, potentially sight-threatening for Muslim patients with glaucoma. The researchers seek to investigate the link between traditional daily Muslim prayer postural changes and intraocular pressure changes.

Official Title
-----------------
Intraocular Pressure Changes Associated With Muslim Prayer Postural Changes

Conditions
-----------------
Glaucoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed with primary open angle glaucoma Must be age 18 and up Provide written informed consent to participate Able to cooperate with ocular examination for 60-90 minutes Able to assume the standing, bowing, and prostrate positions Exclusion Criteria: Special patient populations (children, pregnant women, prisoners etc.) Patients who have had glaucoma surgery that could effect the change in intraocular pressure (ie trabeculectomy, tube-shunts, etc.) Patients who are unable to assume bowing or kneeling positions

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Glaucoma<br>Patients with Glaucoma | |
| Healthy Patients<br>Patients without glaucoma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraocular Pressure |  | Single Exam | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Positional Intraocular Pressure Changes |  | Single Exam | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
glaucoma, intraocular pressure, postural changes
Impact of Cardiac Complications on Outcomes of Patients After Subarachnoid Hemorrhage

Study Overview
=================
Brief Summary
-----------------
Patients with subarachnoid haemorrhage frequently develop cardiac complications affecting their outcome

Official Title
-----------------
Impact of Cardiac Complications on Outcomes of Patients After Subarachnoid Hemorrhage

Conditions
-----------------
Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients diagnosed as spontaneous subarachnoid hemorrhage. SSAH patients aged (18-70 years) of both sexes Exclusion Criteria: History or current evidence of any CNS disease other than SAH which may cause cardiac complications. History or current evidence of medical illness as endocrinal and metabolic disorders which may cause cardiac complications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 Years

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 |
| --- | --- | --- |
| Electrocadriogram | to measure heart rate (beats/minute) in subarachnoid hemorrhage patients | 1 miute | 
| Echocardiogarphy | to measure ejection fraction (%) in subarachnoid hemorrhage patients | 30 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| serum treponin level | to measure serum treponin(ng/ml)in subarachnoid hemorrhage patients | 30 minute |
REVEAL for Respiration Detection

Study Overview
=================
Brief Summary
-----------------
This study will evaluate the correlation between the respiratory rate derived from the Reveal Insertable Cardiac Monitor (ICM) electrocardiogram (ECG) with the respiratory rate obtained from an external respiratory band in patients previously implanted with a Reveal for unexplained syncope or suspected arrhythmia.

Official Title
-----------------
REVEAL for Respiration Detection

Conditions
-----------------
Unexplained Syncope, Suspected Arrhythmia

Intervention / Treatment
-----------------
* Other: Breathing Exercise Cohort


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is implanted with a Reveal ICM or Reveal XT ICM for unexplained syncope or suspected arrhythmia Subject (or the legal representative) is willing to sign informed consent form Subject is 18 years or older or as specified minimal age per local law/regulation Exclusion Criteria: Significant respiratory diseases such as COPD or pulmonary hypertension. Patients with frequent arrhythmias, including PVC's. Patients with known heart failure. Body conditions that would complicate accurate measurement of respiratory rate with the respiration device. Patients which are not able to take the postures as necessary for the study protocol and which cannot walk continuously for a period of 6 minutes. Pregnant or breastfeeding women, or women of child bearing potential and who are not on a reliable form of birth control. Subject is enrolled in one or more concurrent studies that would confound the results of this study

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: Breathing Exercise Cohort<br>All patients enrolled will be asked to wear an external respiration band while performing a series of breathing exercises. | Other: Breathing Exercise Cohort<br>* All patients enrolled will be asked to wear a respiration band and perform a series of breathing exercises.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiration rate derived from the Reveal ICM ECG correlated with the respiration rate from the external respiratory band during a three minute period of normal breathing. |  | Up to 3 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Respiration rate obtained from the REVEAL ICM ECG with the respiratory rate obtained from external respiratory band during three minute periods of periodic, controlled breathing and elevated heart rate. |  | Up to 3 minutes |
Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery

Study Overview
=================
Brief Summary
-----------------
This study involves surveying two matched groups of patients that underwent dermatologic surgery at our department. One group had a documented surgical site infection and the other didn't. All patients will be asked to complete a questionnaire in which they assess the physical appearance of their scars and its psychosocial impact. Results will be compared between the groups.

Detailed Description
-----------------
65 patients with a documented surgical site infection will be compared to 65 patients with normal wound healing in terms of patient reported outcome regarding scar physical appearance and psychosocial impact using SCAR-Q questionnaire.

Official Title
-----------------
Effect of Surgical Site Infections on Patient Reported Cosmetic Outcomes in Dermatologic Surgery

Conditions
-----------------
Surgical Site Infection, Patient Satisfaction

Intervention / Treatment
-----------------
* Other: SCAR-Q survey


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient above 18 years of age that underwent a dermatosurgical procedure at our department between march 2017 and march 2020. Exclusion Criteria: Patients assessed as not suitable for telephone survey due to hearing disabilities or cognitive impairment

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Surgical site infections<br> | Other: SCAR-Q survey<br>* Telephone survey<br>|
| Normal would healing<br> | Other: SCAR-Q survey<br>* Telephone survey<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparing mean values of SCAR-Q scores in both groups | Scar-Q (http://qportfolio.org/scar-q/) is a patient reported outcome instrument in which scars will be assessed in terms of scar appearance and psychosocial impact. Scores will range from 0 (worst) to 100 (best). Scores will be compared between the two groups using either parametric or non-parametric tests depending on the distribution of the results. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Association between patient characteristics and SCAR-Q scores | Score values (0-100) will be correlated to the following patient characteristics (gender, age, type of surgical procedure, anatomic location, and diagnosis of excised lesion) | 3 months |
Clinical Examination of Metal Free Interdental Brushes

Study Overview
=================
Brief Summary
-----------------
The aim of the study was to evaluate the clinical efficacy (Eastman Interdental Bleeding Index, Quigley and Hein) of a novel metal-free interdentalbrush compared to a classig metal-core interdental brush.

Detailed Description
-----------------
Self-performed interdental cleaning is a crucial element in preventing gingival or periodontal diseases. Interdental cleaning is most efficiently performed through usage of interdental brushes. Commonly used metal-core interdental brushes can harbour the risk of hard tissue damage when used inappropriately.The aim of the study was to evaluate the clinical efficacy and patient satisfaction of a novel metal-free interdental brush. This was tested on healthy participants. The control group performed interdental cleaning with a commonly used metal-core interdental brush.

Official Title
-----------------
Clinical Efficacy and Patient Acceptance of Metal and Metal-Free Interdental Brushes: A Controlled Prospective Randomized Study

Conditions
-----------------
Gingivitis, Periodontitis

Intervention / Treatment
-----------------
* Device: metal-free interdental brush
* Device: metal-core interdental brush


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: minimum age: 18 years Exclusion Criteria: allergy against one or more parts of the interdental brushes non-treated periodontitis soft-tissue changes of the mucosa orthodontic treatment removable prosthesis pregnancy anticoagulants drugs causing gingivahyperplasia indications for antibiotics

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: Supportive Care
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: metal-free interdental brushes.<br> | Device: metal-free interdental brush<br>* one time per day<br>* Other names: Fuchs brush&clean;|
| Active Comparator: metal-core interdental brushes<br> | Device: metal-core interdental brush<br>* one time per day<br>* Other names: TePe Interdental brushes;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Analysis of the differences between both groups. Measurements in form of Plaque-Index (Quigley und Hein, Tureskey Mod. 1970) |  | Beginning and after four weeks of use | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Eastman Interdental Bleeding Index, questionnaire of patient acceptance |  | Beginning and after four weeks of use |
Interest of Dynamic Measures of the Pupil in Optic Neuritis

Study Overview
=================
Brief Summary
-----------------
The investigators' hypothesis is that measuring the PCTdynamics would be an easy and reliable symptom to evaluate in pathologies affecting the optic nerve

Detailed Description
-----------------
Physiopathologic study aiming to assess the interest of measuring the lenght of pupil cycle in the dynamic study of the pupillary light reflex.

Official Title
-----------------
Interest of Dynamic Measures of the Pupil in Optic Neuritis

Conditions
-----------------
Optic Neuritis

Intervention / Treatment
-----------------
* Other: measure of pupil diameter


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with unilateral optic neuritis or with multiple sclerosis and an optic neuritis in the previous 5 years Exclusion Criteria: previous history of ophthalmic and neurologic pathology anisocoria minor Patient with a measure of legal protection Pregnancy patient opposition to participation in the study no affiliation to social security

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 |
| --- | --- |
| optic neurotis<br>measure of pupil diameter | Other: measure of pupil diameter<br>* The measure will use infra-red cameras<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison between the PCT frequency of the eye affected by optic neuritis and a sane eye |  | after 1h | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
diameter pupil, multiple sclerosis
Psychological Factors That Influence Severity of Allergic Rhinitis

Study Overview
=================
Brief Summary
-----------------
Objective biomarker of allergic rhinitis severity is necessary for monitoring disease severity and response to treatment in clinical setting and for research. We believe that psychological factors are the missing link between patient-perceived severity of allergic rhinitis and objective biomarkers. In our pilot study, several psychological factors were studied in relation to patient reported outcomes for severity of allergic rhinitis.

Detailed Description
-----------------
Monitoring allergic rhinitis (AR) severity with objective biomarkers is important for the clinical management of patients as well as for research purposes. The most commonly used tool for the assessment of AR severity is the Total Nasal Symptom Score (TNSS). Objective biomarkers like skin prick test size or specific IgE levels don't correlate with TNSS. We studied skin prick test size and specific IgE and several patient reported outcomes including symptom score, medication scores, combined score and Juniper mini rhinitis quality of life questionnaire (RQLQ). Psychometric evaluation was performed using 5 different psychological questionnaires that measure 13 different psychological factors.

Official Title
-----------------
Influence of Immunological and Psychological Factors on Perceived Severity of Seasonal Allergic Rhinitis Caused by Grass Pollen

Conditions
-----------------
Seasonal Allergic Rhinitis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: positive grass pollen skin prick test (SPT) with a wheal diameter >3mm and a history of allergic rhinitis during the grass pollen seasons Exclusion Criteria: positive skin prick test for perennial allergens and allergens with potentially overlapping seasons including cypress, ash/olive, plane, and nettle families

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Symptom score | Symptom severity was graded on a visual analogue scale (VAS), ranging from 0 (no symptoms) to 10 (very severe symptoms) | 2 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
skin prick test, specific IgE, patient reported outcome, psychological factor
ClearUP Longitudinal Pilot Study

Study Overview
=================
Brief Summary
-----------------
Single arm, open label pilot study assessing the longitudinal home use of ClearUp Sinus Pain Relief for four weeks.

Official Title
-----------------
ClearUP Longitudinal Pilot Study

Conditions
-----------------
Sinus Pain, Congestion

Intervention / Treatment
-----------------
* Device: ClearUP Sinus Pain Relief


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-71 years of age (inclusive) Present with symptoms of sinus pain or facial pain in the forehead, periorbital, facial, or nasal region Current pain score ≥ 5 (Numeric Rating Scale 0-10) Frequency of sinus/facial pain at least twice weekly for 1 month Able to read and understand English Agree to participate in the study Able and willing to provide Informed Consent Exclusion Criteria: Do not meet Inclusion Criteria Currently taking or recently taken any oral steroid medications in the last 90 days Sinus surgery in previous 90 days History of Chronic Migraine (≥ 15 headache days per month) Pain location in the vertex, occiput, or temporal region of the skull or in mandibular region Purulent rhinorrhea

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 71 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br> | Device: ClearUP Sinus Pain Relief<br>* Microcurrent Device Treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric Rating Scale for Pain | Change in Numeric Rating Scale for Pain from Baseline to Four Weeks. Scale range 0, no pain, to 10 severe pain. | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Congestion Quantifier 7 | Change in Congestion Quantifier 7 from Baseline to Four Weeks. Congestion Quantifier 7 is a 7 item questionnaire that quantifies congestion symptom severity. It is scored from 0 (no congestion symptoms) to 28 (severe congestions symptoms). | 4 Weeks | 
| Numeric Rating Scale for Pain | Acute Change in Numeric Rating Scale for Pain from Baseline to 6 Hours. Scale range 0, no pain, to 10 severe pain. | 6 hours |