linjc16/ctgov huggingface dataset:
Influence of Different Methods of Measurement in the Accuracy of DES-OSA and P-SAP Scores

Study Overview
=================
Brief Summary
-----------------
DES-OSA and P-SAP scores have been validated to detect OSA (Obstructive Sleep Apnea). One item of P-SAP and DES-OSA is the measurement of neck circumference. The aim of this study is to compare the influence of different methods of neck circumference measurement in the accuracy of DES-OSA and P-SAP scores to detect OSA.

Official Title
-----------------
Influence of Different Methods of Measurement in the Accuracy of DES-OSA and P-SAP Scores

Conditions
-----------------
Sleep Apnea, Obstructive

Intervention / Treatment
-----------------
* Diagnostic Test: Comparison of accuracy of DES-OSA and P-SAP scores


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients scheduled for an anesthetic preoperative consultation Exclusion Criteria: < 18 years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All patients included<br>For all patients scheduled for an anesthetic preoperative consultation, a comparison of accuracy of DES-OSA and P-SAP scores with PSG (polysomnography) will be performed. | Diagnostic Test: Comparison of accuracy of DES-OSA and P-SAP scores<br>* Comparison of accuracy of DES-OSA and P-SAP scores with the result of the PSG (polysomnography)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of DES-OSA | Accuracy of different values of DES-OSA (due to different measurement of neck circumference) with the result of PSG. | one month | 
| Accuracy of P-SAP | Accuracy of different values of P-SAP (due to different measurement of neck circumference) with the result of PSG. | one month |
Validation of Neurokeeper's Algorithm on Patients Undergoing Cardiac Surgery.

Study Overview
=================
Brief Summary
-----------------
The primary objective of the study is to check the ability of Neurokeeper's algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery. The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS ThiS study is a prospective, open label, single arm, self control, single center study. This study will be conducted in 50 subjects according to the inclusions/exclusions criteria.

Conditions
-----------------
Stroke

Intervention / Treatment
-----------------
* Device: Neurokeeper stroke detector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old. Patients undergoing cardiac surgery . Exclusion Criteria: Previous major hemispheric stroke. Any known major hemispheric lesion. Significant movement disorder. Local skull or skin affliction which prevents electrodes application. Any known condition which in the opinion of the investigator may interfere with the protocol implementation.

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 |
| --- | --- |
| Patients undergoing cardiac surgery<br> | Device: Neurokeeper stroke detector<br>* Electrophisoloigcal monitoring<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological detrioration detection | The primary objective of the study is to validate an EEG base algorithm system to detect and monitor changes in cerebral electrophysiological parameters as compared to clinical evaluation in patients undergoing cardiac surgery. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time from deterioration to detection | The secondary objectives is correlations of EEG + ERP measurements with clinical evaluations as assessed by NIHSS |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Stroke
Is Doppler Necessary in Haemorrhoidal Artery Ligation Operation?

Study Overview
=================
Brief Summary
-----------------
Haemorrhoidal artery ligation operation (HALO) is an operation that ties off vessels to piles. This study examines whether the ultrasound (doppler) is necessary to guide this tying off or not.

Detailed Description
-----------------
HALO (haemorrhoidal artery ligation operation) has proved to be a popular and effective treatment for bleeding piles. Currently the HALO is a Doppler guided procedure though when the Doppler mechanism does not function it has been noted that the results are similar. This prompts the question does the Doppler guide the operation to tie off the important vessels to shrink he piles, or can the vessels that underlie the visible piles be treated without Doppler. Professor Phillips from St.Marks has reviewed the protocol and agrees that it is well designed and worthwhile.

Official Title
-----------------
Haemorrhoidal Artery Ligation Operation; is Doppler Necessary?

Conditions
-----------------
Piles, Bleeding

Intervention / Treatment
-----------------
* Procedure: HALO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: For consenting adults (18-90 years) with grade one and two piles listed for HALO at Poole hospital by three consultants trained in the HALO technique, the patients will be offered to be involved in the study. Exclusion Criteria: Other grades of piles, age outside 18-90 or other anal condition

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| Doppler<br>Those patients where the doppler was randomised to be on | Procedure: HALO<br>* Ligation of haemorrhoidal arteries<br>|
| Non doppler patients<br>those with no doppler guidance | Procedure: HALO<br>* Ligation of haemorrhoidal arteries<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement of rectal bleeding |  | 3-6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Satisfaction with the HALO procedure with or without doppler guidance |  | 3-6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HEMORRHOIDS, TREATMENT, PILES, BLEEDING, HALO
An Evaluation of Exercise Tolerance in Asthmatic Patients

Study Overview
=================
Brief Summary
-----------------
To evaluate exercise tolerance.

Conditions
-----------------
To Evaluate

Intervention / Treatment
-----------------
* Other: EXERCISE TRAINING


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - 40-50 YEARS Exclusion Criteria: NO EXCERBATIONS

Ages Eligible for Study
-----------------
Minimum Age: 40 Years
Maximum 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 |
| --- | --- |
| EXERCISE TOLERANCE<br> | Other: EXERCISE TRAINING<br>* EXERCISE TRAINING<br>|

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
-----------------
ASTHMA
Extension Study of Enteric-coated Mycophenolate Sodium in Combination With Full Dose or Reduced Dose Cyclosporine Microemulsion in Patients With de Novo Kidney Transplants

Study Overview
=================
Brief Summary
-----------------
This extension study is considered to allow patients being treated with EC-MPS to collect further information on the long-term safety of this drug.

Official Title
-----------------
A One-year, Randomized, Open Label, Parallel Group Study to Investigate the Safety and the Effect of Enteric-coated Mycophenolate Sodium (EC-MPS) in Combination With Either Full Dose or Reduced Dose Cyclosporine Microemulsion in de Novo Kidney Transplant Recipients

Conditions
-----------------
Renal Transplantation

Intervention / Treatment
-----------------
* Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion/ Exclusion criteria - All patients who completed study CERL080A2405-DE01 and who are willing to continue treatment with EC-MPS. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Enteric-Coated Mycophenolate Sodium (EC-MPS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy based on level of serum creatinine and calculated creatinine clearance 6 months post transplantation. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy based on the level of serum creatinine and calculated creatinine clearance 12 months post transplantation. |  |  | 
| Safety and tolerability of enteric-coated mycophenolate sodium at 6 and 12 months post transplantation |  |  | 
| Pharmacokinetics enteric coated mycophenolate sodium in a randomized subgroup |  |  | 
| Efficacy based on the incidence of biopsy-proven acute rejection, graft loss or death 6 and 12 months post transplantation. |  |  | 
| Efficacy based on the incidence of biopsy-proven acute rejection at 6 and 12 months post transplantation. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal transplantation, Enteric-Coated Mycophenolate Sodium (EC-MPS)
Clinical Trial to Compare the Pharmacokinetics and Pharmacodynamics After Oral Administration of Glucophage and HL-018

Study Overview
=================
Brief Summary
-----------------
This study is designed to to compare the pharmacokinetic and pharmacodynamic characteristics and safety after oral administration of Glucophage with those after oral administration of HL-018 in healthy male volunteers

Official Title
-----------------
A Clinical Trial to Compare the Pharmacokinetic and Pharmacodynamic Characteristics and Safety After Oral Administration of Glucophage With Those After Oral Administration of HL-018 in Healthy Male Volunteers

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

Intervention / Treatment
-----------------
* Drug: Glucophage 500mg
* Drug: HL-018 500mg
* Other: No administration of Drug


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult males aged 19 to 50 years at screening. No significant congenital/chronic disease. No symptoms in physical examination. Appropriate subjects as determined by past medical history, laboratory tests, serology and urinalysis. Be able to understand the objective, method of the study, the characteristics of investigational drug, and comply with the requirement of the study. Subject must provide written informed consent prior to study participation. Exclusion Criteria: History or presence of liver, kidney, or nervous system disease, respiratory disorders, endocrinological disorders, hemato-oncologic, cardiovascular or psychiatric or cognitive disorders. History of gastrointestinal disorders (bleeding, ulceration, hemorrhoids, piles) or disorders of absorption, distribution, metabolism, excretion. History of known hypersensitivity to drugs including metformin.

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>Reference | Drug: Glucophage 500mg<br>* Single Oral Dose of<br>|
| Experimental: B<br>Test | Drug: HL-018 500mg<br>* Single Oral Dose of<br>|
| Placebo Comparator: C<br>Placebo | Other: No administration of Drug<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics (AUClast and Cmax) |  | 24hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
healthy volunteers
Electrical Stimulation in Traumatic Brain Injury (TBI) Induced Aphasia

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate whether a tDCS-accompanied intensive naming therapy leads to a performance improvement in patients with chronic aphasia induced by a moderate TBI

Official Title
-----------------
The Effect of Transcranial Direct Current Stimulation (tDCS) on Naming Ability in Patients With Traumatic Brain Injury Induced Aphasia

Conditions
-----------------
Aphasia, TBI (Traumatic Brain Injury), tDCS

Intervention / Treatment
-----------------
* Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: aphasia assessed by Aachener Aphasie Test (AAT) > 6 month after moderate TBI Age: 18 - 80 years right handedness Exclusion Criteria: dementia or other neurological diseases History of severe alcoholism or use of drugs Severe psychiatric disorders such as depression, psychosis (if not in remission) Severe untreated medical problems such as cancer

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: stimulation group<br> | Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation<br>* anodal tDCS or sham stimulation will be combined with an intensive naming training and the number of items that could be named will be assessed immediately after the intervention.<br>|
| Sham Comparator: sham stimulation<br> | Other: anodal transcranial direct current stimulation (tDCS)- accompanied naming therapy or sham stimulation<br>* anodal tDCS or sham stimulation will be combined with an intensive naming training and the number of items that could be named will be assessed immediately after the intervention.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Naming ability assessed by | Performance in a standardised naming task (Boston Naming Task, BNT) under anodal tDCS compared to sham assessed immediately after training period | 2 weeks |
A Multicenter Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel When Used to Treat Actinic Keratoses (AKs) on the Non Head Locations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether topical application of PEP005 is effective for the treatment of actinic keratoses.

Official Title
-----------------
A Multi-center, Randomized, Parallel Group, Double-blind, Vehicle-controlled Study to Evaluate the Efficacy and Safety of PEP005 (Ingenol Mebutate) Gel, 0.05%, In Patients With Actinic Keratoses on Non-head Locations (REGION-Ib)

Conditions
-----------------
Actinic Keratoses

Intervention / Treatment
-----------------
* Drug: PEP005 (ingenol mebutate) Gel
* Drug: Vehicle gel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must be male or female and at least 18 years of age. Female patients must be of: Non-childbearing potential; Childbearing potential, provided negative serum and urine pregnancy test and using effective contraception. 4 to 8 AK lesions on non-head locations. Exclusion Criteria: Cosmetic or therapeutic procedures within 2 weeks and within 2 cm of the selected treatment area. Treatment with immunomodulators, or interferon/ interferon inducers or systemic medications that suppress the immune system within 4 weeks. Treatment with 5-FU, imiquimod, diclofenac, or photodynamic therapy within 8 weeks and 2 cm of treatment area

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: PEP005 (ingenol mebutate) Gel<br>PEP005 (ingenol mebutate) Gel 0.05% once daily for 2 consecutive days | Drug: PEP005 (ingenol mebutate) Gel<br>* two day treatment<br>|
| Placebo Comparator: Vehicle gel<br>Vehicle gel once daily for 2 consecutive days | Drug: Vehicle gel<br>* two day treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Complete Clearance of Actinic Keratoses (AK) Lesions | Proportion of Patients with Complete Clearance of the treatment field defined as no clinically visible Actinic Keratoses (AK) lesions in the selected treatment area | 57 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Patients With Partial Clearance of Actinic Keratoses (AK) Lesions | Proportion of patients with Partial Clearance defined as ≥ 75 % reduction in the number of Actinic Keratoses (AK) lesions identified at baseline in the treatment area | 57 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Peplin, Actinic keratosis, PEP005
CD5024 1% [Ivermectin 1%] Cream Versus Metronidazole 0.75% Cream in Papulopustular Rosacea (PPR) Study

Study Overview
=================
Brief Summary
-----------------
Study objectives: To compare efficacy and safety of Ivermectin 1% cream versus metronidazole 0.75% cream in subjects with papulopustular rosacea after 16-week topical treatment. And to compare, for subjects initially successfully treated by 16 weeks treatment, Ivermectin 1 % cream versus metronidazole 0.75% cream during a 36-week extension period by assessing, the time of first relapse, the relapse rate, and the number of days free of treatment

Official Title
-----------------
Efficacy and Safety of CD5024 1% Cream Versus Metronidazole 0.75% Cream in Subjects With Papulopustular Rosacea Over 16 Weeks Treatment, Followed by a 36-week Extension Period.

Conditions
-----------------
Papulopustular Rosacea

Intervention / Treatment
-----------------
* Drug: Ivermectin 1% cream
* Drug: Metronidazole 0.75% cream


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with papulopustular rosacea scored 3 (moderate) or 4 (severe) according to the Investigator Global Assessment (IGA), Subjects with at least 15 but not more than 70 inflammatory lesions (papules and pustules) on the face. Exclusion Criteria: Subjects with particular forms of rosacea (rosacea conglobate, rosacea fulminant, isolated rhinophyma, isolated pustulosis of the chin) or other facial dermatoses that may be confounded with papulopustular rosacea, such as peri oral dermatitis, facial keratosis pilar, or seborrheic dermatitis and acne, Subjects with rosacea with more than two nodules on the face.

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: Ivermectin 1% cream<br> | Drug: Ivermectin 1% cream<br>* Ivermectin 1% cream applied once daily on the face during 16-week plus 36-week extension period.<br>* Other names: Soolantra;|
| Active Comparator: Metronidazole 0.75% cream<br> | Drug: Metronidazole 0.75% cream<br>* Metronidazole 0.75% cream applied twice daily on the face during 16-week plus 36-week extension period.<br>* Other names: Metronidazole;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Inflammatory Lesions From Baseline to Week 16 | Efficacy of Ivermectin versus Metronidazole as determined by the percent change in inflammatory lesions after a 16-week treatment period | Baseline and Week 16 |