linjc16/ctgov huggingface dataset:
Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail

Study Overview
=================
Brief Summary
-----------------
This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Detailed Description
-----------------
This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Safety and Efficacy of NVXT Solution in Patients With Mild-to-Moderate Fungal Infection of the Toe Nail

Conditions
-----------------
Onychomycosis

Intervention / Treatment
-----------------
* Drug: NVXT Solution
* Drug: Vehicle of test product


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically diagnosed onychomycosis Presence of dermatophyte fungal infection with no current topical or systemic antifungal therapy Clinical diagnosis of mild-to-moderate fungal infection of at least one toe involving 10-50% of the nail area, without involvement of one of the lunular proximal regions Positive potassium hydroxide mount preparation Positive fungal culture for a dermatophyte Exclusion Criteria: Nail or anatomical abnormalities of the toe that may interfere with evaluations or dosing compliance

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| Experimental: NVXT Solution<br>NVXT Solution once daily for 60 days | Drug: NVXT Solution<br>* NVXT Solution, applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.<br>* Other names: NVXT;|
| Placebo Comparator: Vehicle of test product<br>Vehicle of test product, once daily for 60 days | Drug: Vehicle of test product<br>* Vehicle of test product applied to infected toe nails and 0.5 mm of adjacent skin once daily for 60 days.<br>* Other names: Placebo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Negative Fungal Culture | To assess number of participants with negative fungal culture after repeated once-daily topical applications for 28 days | 28 days |
Observational Study to Evaluate Long-term Safety and Biodegradability of YVOIRE Volume s

Study Overview
=================
Brief Summary
-----------------
To evaluate long-term safety of YVOIRE volume s by incidence of adverse events including injection site local reactions and biodegradability.

Official Title
-----------------
A Multi-center, Prospective and Observational Study to Evaluate Long-term Safety and Biodegradability of Modified Sodium Hyaluronate Gel (YVOIRE Volume s) Injected for Correction of Nasolabial Folds

Conditions
-----------------
Correction of Nasolabial Folds

Intervention / Treatment
-----------------
* Device: YVOIRE volume s


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects whose age is over 18 years old and under 65 years old Subjects whose WSRS grade is equal or greater than 2 Subjects must be willing and able to provide written informed consent form Subjects who are scheduled to be treated with YVOIRE volumes for facial tissue augmentation to correct the nasolabial folds Exclusion Criteria: Subjects who are sensitive to hyaluronic acid or any excipients of YVOIRE volume s Subjects who have received permanent implantation (silicone, PAAG, PMMA, CaHA etc) on the nasolabial folds Subjects who have received nonpermanent aesthetic treatments, such as botulinum toxin injection or filler on the nasolabial folds within 9 months before screening Subjects who have received face lifting or plastic surgery on face within 9 months before screening Subjects who have received laser therapy on the nasolabial folds, chemical peeling or peeling on face within 3 months before the screening Subjects who have any skin diseases (including inflammation and skin cancer) or infectious diseases on the injection sites Subjects who tend to have hypertrophic scars Subjects with a history of streptococcal disease, severe allergy or anaphylaxis or bleeding disorders. Women in pregnancy or lactation

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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 |
| --- | --- |
| YVOIRE volume s<br>Treatment with YVOIRE volume s | Device: YVOIRE volume s<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Device-related Adverse Events |  | Until subject reaching total biodegradation criterion (WSRS change) ; an expected average of 2 years |
The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation

Study Overview
=================
Brief Summary
-----------------
The QTc interval is affected by heart rate, medications and changes in the autonomic nervous system. The endotracheal laryngoscopy, the necessary step during general anesthesia, prolongs QTc interval. Changes in the flow of ion currents could result from the genetic variation of myocardial ion channels by gene polymorphism. This study is to investigate the association of cardiac ion channel related gene polymorphism and prolonged QTc interval after endotracheal intubation in adult patients.

Official Title
-----------------
The Association of Cardiac Ion Channel Related Gene Polymorphism and Prolonged QTc Interval After Endotracheal Intubation

Conditions
-----------------
Emergence Delirium

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-65 years old scheduled for general anesthesia requiring direct laryngoscopy Exclusion Criteria: Patients taking antihypertensive medication (beta-blocker, CCB) patients taking other medications known to affect QTc interval Patients with abnormal ECG and prolonged QTc (>500 msec) Diabetes, liver disease, kidney disease, heart failure, congenital heart disease Severe electrolyte imbalance illiterate, foreigners who cannot understand the consent form

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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 |
| --- | --- | --- |
| QTc interval | QTc interval prolongs followed by laryngoscopy due to changes in the autonomic nervous system. The restoration of the prolonged QTc could also be affected by the balance of autonomic nervous system or changes in the related cardiac ion channels. | Before anesthesia, Before laryngoscopy, Right after laryngoscopy, 5 minutes after laryngoscopy |
The Effects of TAP Block on Postsurgical Pain After Minimally Invasive Partial Nephrectomy:

Study Overview
=================
Brief Summary
-----------------
Single-center study in order to assess whether the tap block can make extremely beneficial in terms of reducing the acute and chronic pain as well as for use of opioids and side effects related to it in patients undergoing surgery to minimally invasive partial nephrectomy.

Official Title
-----------------
The Effects of Ultrasound-guided Transversus Abdominis Plane Block on Acute and Chronic Postsurgical Pain After Robotic Partial Nephrectomy. A Prospective, Randomized, Clinical Trial

Conditions
-----------------
Acute Pain, Chronic Pain

Intervention / Treatment
-----------------
* Procedure: Tap block
* Procedure: intravenous Patient controlled analgesia
* Drug: Morphine
* Drug: Ropivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: asa score I,II,II patients scheduled for robot assisted partial nephrectomy Exclusion Criteria: previous abdominal surgery inability to provide informed consent allergy to the anesthetic drugs

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Tap Block<br>the intervention will be tap block after induction of anesthesia with ropivacaine 0,5% 15ml and continuous patient-controlled analgesia with morphine | Procedure: Tap block<br>* intravenous patient-controlled analgesia with morphine and tap block with subcostal and posterior approach with ropivacaine 0,5% 15ml+15ml<br>Procedure: intravenous Patient controlled analgesia<br>* intravenous patient-controlled analgesia with morphine<br>Drug: Morphine<br> <br> Drug: Ropivacaine<br> <br> |
| Active Comparator: No Tap Block<br>the patients who not receive tap block but they will be as intervention intravenous Patient controlled analgesia | Procedure: intravenous Patient controlled analgesia<br>* intravenous patient-controlled analgesia with morphine<br>Drug: Morphine<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consuption 24 hr after surgery | Cumulative morphine consuption (mg) 24 hr starting from the time of extubation. | 24 hours | 
| Acute pain after surgery measured with Numerical Rating Scale | patients were assessed for pain, according to Numerical Rating Scale (NRS; 0: no pain to 10: worst pain imaginable) | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Minimally invasive surgery, Partial nephrectomy
Study Of The Long Term Outcome Of Tuberculous Meningitis In Vietnamese Adults Treated With Adjunctive Dexamethasone

Study Overview
=================
Brief Summary
-----------------
All patients who were alive at the end of the dexamethasone treatment trial conducted by Oxford University CLinical Research Unit from 2001-2005 (n=340) will be eligible to participate in this long-term follow-up study. All eligible and consenting patients will undergo an assesment consisting of a simple questionnaire, a clinical examination and a blood test. Data collected will focus on survival, neurological disability and tuberculosis relapse. Data will be collected in individual case record forms and entered into a computer database.

Official Title
-----------------
Study Of The Long Term Outcome Of Tuberculous Meningitis In Vietnamese Adults Treated With Adjunctive Dexamethasone

Conditions
-----------------
Tuberculosis Meningitis

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:Patients were alive at the end of the dexamethasone study (n=340) will be eligible to participate in this long-term follow-up study Informed consent Exclusion Criteria: Patients without informed consent

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
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 |
| --- | --- |
| Survivors of TBM trial 2001-2005<br> | Other: Observation<br>* Collection of mortality data at 5 years post trial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival |  | 5 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neurological disability |  | 5 years | 
| Tuberculosis relapse rate |  | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tuberculosis meningitis
Linear Focused Shockwave Treatment for Erectile Dysfunction

Study Overview
=================
Brief Summary
-----------------
The study is aimed at comparing the performance of protocols employing one and two sessions per week, respectively. The study hypothesis claims that there is no significant difference between the performances of the compared protocols.

Official Title
-----------------
Linear Focused Shockwave Treatment for Erectile Dysfunction

Conditions
-----------------
Vasculogenic Erectile Dysfunction

Intervention / Treatment
-----------------
* Device: Renova


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Good general health Vasculogenic ED- Erectile Dysfunction, according to physician judgment, for at least 6 months and for no longer than 5 years. International Index of Erectile Function 6 (IIEF-EF) between 17 and 25 Satisfactory response to the use of PDE5 (Phosphodiesterase type 5) inhibitors Stable sexual relationship for at least 3 months prior to treatment Minimum of two sexual attempts per month Exclusion Criteria: Hormonal, neurological or psychological pathology Past radical prostatectomy or extensive pelvic surgery Recovering from cancer during last year Any unstable medical, psychiatric, spinal cord injury and penile anatomical abnormalities Clinically significant chronic hematological disease Anti-androgens, oral or injectable androgens Past radiotherapy treatment of the pelvic region International normalized ratio (INR) > 3 for patients using blood thinners (such as Coumadin)

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 80 Years

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

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: long protocol<br>Renova | Device: Renova<br>* Low- Intensity Shockwave<br>|
| Experimental: short protocol<br>Renova | Device: Renova<br>* Low- Intensity Shockwave<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IIEF-EF- International Index of Erectile Function questionnaire score | the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment | 1 month post treatment | 
| IIEF-EF questionnaire score |  | 3 months post treatment | 
| IIEF-EF questionnaire score | the IIEF-EF questionnaire score will be evaluated at baseline, 1,3, and 6 months after end of treatment | 6 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| SEP- Sexual Encounter Profile: Questions 2 and 3 |  | 1, 3 and 6 months post treatment | 
| GAQ- Global Assessment Questions |  | 1, 3 and 6 months post treatment | 
| EHS- Erection Hardness Score |  | 1, 3 and 6 months post treatment |
Non-interventional Observational Study on WHO-5 Questionnaire Application in Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
To assess the predictive value of sequential administration of WHO-5 and MDI (Major Depression Inventory) for the clinical management of Parkinson Disease (PD) patients by determination of the prevalence of depression in PD patients, based on MDI severity categories and the self-rating scale WHO-5, where poor well being was indicated. exploration of influencing factors (PD status, therapeutic status) on the prevalence of MDI depression categories.

Official Title
-----------------
Application of the WHO-5 Well-being Index (WHO-5) as a Screening Instrument for Depression in Parkinson's Disease

Conditions
-----------------
Parkinson Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: PD patients attending one of the participating neurologist practices during 2 fixed weeks in November 2008 Idiopathic PD with or without fluctuations Male or female PD patients aged at least 30 Ability to reliably complete self-rating scales (WHO-5, MDI) ), according to the physician's judgement. Written informed consent by the patient for study participation. Exclusion Criteria: PD Patients who only attend the practice to get a prescription and are not seen by the doctor on that day Patients who are not able to understand the questionnaires (e.g. due to mental impairment or language problems).

Ages Eligible for Study
-----------------
Minimum Age: 30 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 |
| --- | --- | --- |
| Prevalence of patients with depressive symptoms (based on WHO-5 and MDI) in total and in subgroups |  | day 1 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| WHO-5 score and items |  | day 1 | 
| MDI score (for a subgroup of patients with WHO-5 score < 13 or any WHO-5 item rated with 0 or 1) |  | day 1 | 
| Correlation of WHO-5 and MDI (for a subgroup of patients with a WHO-5 score < 13 or any WHO-5 item rated with 0 or 1) in PD patients |  | day 1 | 
| Investigator assessment of the applicability of the WHO-5 for screening for depression in PD patients |  | day 1 |
Indications and Interest of US-guided Synovial Biopsies Performed in Clinical Practice

Study Overview
=================
Brief Summary
-----------------
Synovial biopsies are now routinely performed both in research and in clinical practice. The developments of ultrasound (US) and of US-guided needle biopsies devices have facilitated their use and tolerance by the patients. However, their interest in clinical practice in the context of an undifferentiated arthritis remains debated.

Detailed Description
-----------------
In this study, the investigators will collect all the synovial biopsies performed in clinical practice in 18 Rheumatology Unit throughout France. All the participants received a standardized training on US-guided synovial biopsies. For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form. The investigator will determine the number of cases where the synovial biopsy allows drawing a definite diagnosis.

Official Title
-----------------
Interest of Synovial Biopsy in the Etiological Assessment of Arthritis of Undetermined Origin: Multicenter Prospective Series

Conditions
-----------------
Arthritis

Intervention / Treatment
-----------------
* Other: US-guided synovial biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients undergoing an US-guided synovial biopsy in clinical practice in the context of an arthritis of unknown origin Exclusion Criteria:

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

| Intervention/Treatment |
| --- |
|Other: US-guided synovial biopsy|Needle Synovial biopsy performed using a Tru-cut® device.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of cases where the synovial biopsy allows drawing a definite diagnosis | Final diagnosis will be classified in 5 groups: infectious, crystal induced arthritis, tumoral, inflammatory rheumatisms, others (amyloidosis etc …) | 10 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Indications, tolerance, complications, number and type of analysis for each sample, results of pathology, bacteriology, mycobacteriology | For each biopsy, the indications, clinical presentation, procedure (length, tolerance), biopsy results (Pathology, bacteriology, etc ...) will be collected in a Clinical Research Form. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
synovial biopsy, US guided synovial biopsy
A Comparison of Pain Scales in Patients With Disorder of Consciousness Following Craniotomy

Study Overview
=================
Brief Summary
-----------------
This study aims to test validity, reliability and practicality of translated NCS, CNPI and FLACC in unconscious patients in 48 hour following craniotomy.

Detailed Description
-----------------
This study aims to test predictive validity (sensitivity and specificity), content validity, concurrent validity, construct validity, inter-rater reliability and practicality of translated Nociception Coma Scale (NCS) , Checklist of Non Verbal Pain Indicator (CNPI) and the Faces, Legs, Activity, Cry, Consolability Observation Tool (FLACC) in unconscious patients in 48 hour following craniotomy.

Official Title
-----------------
A Comparison of Pain Scales in Patients With Disorder of Consciousness Following Craniotomy

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 years old Preoperative intracranial lesion which predicts delayed recovery Disorder of consciousness within 48 hours after craniotomy assessed by using Coma Recovery Scale-Revised (CRS-R) 17 Not received postoperative sedation or muscle relaxants Exclusion Criteria: Documented history of prior brain injury History of delayed development Prior psychiatric illness Prior neurological illness Superior limb contusion, fracture, paralysis -cannot move Thalamic hemorrhage -cannot express feeling

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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pain scale, craniotomy