linjc16/ctgov huggingface dataset:
An Open-Label Follow-on Trial to Assess the Long-Term Safety and Efficacy of Oral SPM 927 in Subjects With Postherpetic Neuralgia (PHN)

Study Overview
=================
Brief Summary
-----------------
This trial was the follow-on trial to a preceeding double-blind, placebo controlled trial which included patients with at least moderate pain due to postherpetic neuralgia. It was conducted at six sites in Germany and has been clinically finalized. The patients had successfully completed the above mentioned trial in postherpetic neuralgia and, in the investigator's opinion, would benefit from long-term administration of Lacosamide. After a 1-week run-in phase the patients were uptitrated to their optimal dose and then continued into the maintenance phase. Dose adjustments were allowed throughout the trial.The change in pain was measured daily as well as interference of pain with sleep and general activity. As per protocol this trial was terminated after two years of treatment.

Official Title
-----------------
An Open-Label Follow-on Trial to Assess the Long-Term Safety and Efficacy of Oral SPM 927 in Subjects With Postherpetic Neuralgia (PHN)

Conditions
-----------------
Postherpetic Neuralgia

Intervention / Treatment
-----------------
* Drug: SPM 927


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Postherpetic Neuralgia Exclusion Criteria: Does not benefit from long term treatment

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

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: SPM 927|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Circulating PRCP in STEMI Patients Undergoing Primary PCI

Study Overview
=================
Brief Summary
-----------------
Purpose: The purpose of this study is to evaluate the impact of acute ST-segment elevation myocardial infarction (STEMI) and primary percutaneous coronary intervention (PCI) on circulating prolylcarboxypeptidase (PRCP) level and activity.

Conditions
-----------------
Myocardial Infarction, Percutaneous Coronary Intervention, PRCP

Intervention / Treatment
-----------------
* Procedure: Primary PCI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Admitted for primary PCI for STEMI involving the LAD within 12 hours of onset of symptoms. STEMI will be defined as typical ECG changes (ST segment elevation ≥2mm in 2 or more precordial leads) associated with acute chest pain or an elevation of cardiac enzymes; Age ≥18 years; Informed consent from subject or next of kin. Exclusion Criteria: Nonischaemic Cardiomyopathy; Cardiac surgery planed in the 6 months; Mechanical complication of STEMI (ventricular septal rupture, free wall rupture, acute severe mitral regurgitation); Renal or hepatic failure; Malignancy, HIV, or central nervous system disorder; Cardiopulmonary resuscitation >15 min and compromised level of consciousness; Cardiogenic shock; Current participation in any research study involving investigational drugs or devices; No written consensus; Previous myocardial infarction.

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 |
| --- | --- |
| STEMI patients<br> | Procedure: Primary PCI<br> <br> |
| Healthy subjects<br> | |
| Unstable angina<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating PRCP level |  | 1 month | 
| Circulating PRCP activity |  | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Circulating Ang II level |  | 1 month | 
| Circulating Ang-(1-7) level |  | 1 month | 
| Circulating BK-(1-9) level |  | 1 month | 
| Circulating KBK-(1-9) level |  | 1 month |
Virtual Reality in Motor Performance and Quality of Life in Patients With Parkinson's Disease

Study Overview
=================
Brief Summary
-----------------
Treatment with Nintendo wii is higher to physical therapy conventional in the quality of life and motor performance in patients with Parkinson's disease.

Detailed Description
-----------------
The aim of this study is to assess if the treatment of rehabilitation with Nintendo wii is higher to the conventional in the quality of life and motor performance in patients with Parkinson's disease.

Official Title
-----------------
Virtual Reality in Motor Performance and Quality of Life in Patients With Parkinson's Disease

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

Intervention / Treatment
-----------------
* Other: treatment with Nintendo wii.
* Other: Physical therapy conventional.


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Parkinson's disease Both the sex with age between 50 and 80 years To be in it I serve as apprentice of 1 the 3,0 in the scale of Hoehn Yahr Exclusion Criteria: Cognitive impairment Poorly controlled arterial hypertension Poorly controlled Cardiopathy

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 80 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: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group - Nintendo wii.<br> | Other: treatment with Nintendo wii.<br>* Participants Will receive treatment with Nintendo Wii over one months. These Patients Will Be subjected to mobilization of stem and stretching. Then Will Be Submitted to Nintendo wii games. Will Be Submitted This group three times a week to a treatment protocol with boxing exercises with wii sports and wii fit<br>|
| Active Comparator: conventional - Physical Therapy<br> | Other: Physical therapy conventional.<br>* Conventional exercises used with the same goals for the group with wii<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Parkinson's disease questionnaire (PDQ-39) | 4 weeks (Baseline and after four weeks) | 
| Motor performance | the Unified Parkinson's Disease Rating Scale (UPDRS.) | 4 weeks (Baseline and after four weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Parkinson's disease, Physical therapy, Virtual Reality, Quality of life, Motor performance
Improving the Diagnosis of Sexually Transmitted Infections in Emergency Rooms

Study Overview
=================
Brief Summary
-----------------
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of sexually transmitted infections caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC sexually infection transmitted tests . Most sexually transmitted infections can be diagnosed from an anal swab which is not routinely performed. In this study, we suggest to test the hypothesis that anal swab in addition to the routine genital swab would increase by at least 5% the diagnosis capacity of sexually transmitted infections after the POC tests.

Conditions
-----------------
Sexually Transmitted Infection

Intervention / Treatment
-----------------
* Other: Anal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted for sexually transmitted infection in emergency room requiring a microbiological examination with a Sexually Transmitted Infection POC kit Patient who freely signed the informed consent form Patient affiliated to a social security regime Exclusion criteria Pregnant or breastfeeding women Adult patient under guardianship Patient deprived with liberty under court order Patient refusing or unable to sign the informed consent form
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: Patients admitted for sexually transmitted infection<br> | Other: Anal swab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients with a confirmed etiological diagnosis of sexually transmitted infection |  | 1 day |
Study of the Association Between Presbycusis With the Incidence of Frailty

Study Overview
=================
Brief Summary
-----------------
The objective of the project is to establish the association between presbycusis and the incidence of frailty in humans in order to establish hearing loss with age as another index for the diagnosis of frailty; As well as studying the effect of exposure to polyphenols in the diet on presbycusis and frailty. Human study: volunteers between 60 and 99 years old, men and women during a period of 6 months, questions and answers, audiometries, study of fragility, analysis of antioxidants in blood, and samples of urine will be measured Total polyphenols and oxidant capacity.

Official Title
-----------------
Study of the Association Between Presbycusis With the Incidence of Frailty. Intake of Polyphenols for the Prevention of Presbycusis: Effects on Frailty

Conditions
-----------------
Presbycusis, Frailty Syndrome, Oxidative Stress

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age Exclusion Criteria: Disease of the hearing system Serious illness (e.g. tumor) Dementia Total dependence

Ages Eligible for Study
-----------------
Minimum Age: 60 Years
Maximum Age: 99 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 |
| --- | --- | --- |
| Auditory function | study by pure tone audiometry, calculating an average of the thresholds of hearing at 0.5, 1, 2 and 4 kilohertz classifying according to their hearing thresholds to the participants in: normal hearing ≤ 25decibel, slight hearing loss = 26-40 decibel; Y moderate-greater hearing loss> 40 decibel (according to the World Health Organization). | 6 months | 
| Frailty | Fragility will be determined at the beginning and at the end of the study period using the 5 Fried indexes: weakness, low speed, low physical activity, exhaustion and weight loss. Participants with 3 or more criteria are classified as fragile, with 1-2 criteria as pre-fragile, and those without any criteria are not considered fragile. Thus, individuals will be classified in the analyzes as non-fragile, pre-fragile and fragile. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Determination of total polyphenols in urine | 24-hour urine samples using the method Folin -Ciocalteu. | measured twice in each volunteer, at the beginning and end of the study period (6 months) | 
| Blood analysis, | routine biochemistry and determination of: carotenoids, vitamins E and D | It will be performed at the beginning and at end of the study period (6 months) | 
| Microbiota | Stool microbiota analysis | It will be performed at the beginning and at end of the study period (6 months) |
Kidney Function in Patients With Bladder Exstrophy

Study Overview
=================
Brief Summary
-----------------
Patients with classical bladder exstrophy undergo many surgical interventions with secondary urinary tract infections complicating their course. lately primary definitive surgical correction of this congenital anomaly has been implemented with satisfactory results. Although bladder exstrophy patients are born with normal kidneys, infectious and mechanical surgical complications can potentially damage their kidneys in the long-term. therefore we decided to evaluate renal function in the long-term in these patients.

Official Title
-----------------
Evaluation of Long-term Renal Function in Patients After Surgical Repair of Classical Bladder Exstrophy

Conditions
-----------------
GFR, Classic Bladder Exstrophy, Renal Function, Proteinuria

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with classic bladder exstrophy treated and followed in Pediatric urology clinic in Dana Children Hospital and Outpatient Clinic Exclusion Criteria: No

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum 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 |
| --- | --- | --- |
| Renal function | Creatinine and GFR estimation , proteinuria, albuminuria will be assessed as measures of renal function as well as renal mass estimation through renal size as by ultrasound and in certain cases through dimercaptosucicnic acid (DMSA)renal scan | 1 day (last visit ) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Classic Bladder Exstrophy, Renal function, GFR, Proteinuria
A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms

Study Overview
=================
Brief Summary
-----------------
This study will included 20 children presenting with epilepsy with spasms. It aims to offer these children, non invasively and without supplementary examinations, a recording of local and cerebral hemodynamic changes concomitant with an electroencephalographic recording during epileptic episodes. This will be carried out by combining optical imaging using near infra-red spectroscopy (NIRS) with electroencephalography (EEG), in a simultaneous high-resolution (HR) recording. This study is among those based on multimodal analyses of epilepsy, combining methods of analysis of electrical activity (electrical imaging) and hemodynamics (optical imaging). Surface electroencephalography (EEG) is a precious tool enabling the study of neuronal dysfunction from a functional point view. It is used in the routine follow-up of children with epilepsy. Optical imaging is a promising medical imaging technique. It uses light in the spectral regions of near infra-red as a source of radiation. It is quantitative, rapid, non invasive, and inoffensive which could easily be used at the child's bedside or in a clinical setting and can provide metabolic information about cerebral function. This study is multidisciplinary, which calls upon the skills of neurophysiologists, biophysicists, and clinicians

Official Title
-----------------
A Study of Hemodynamic Changes Using Near Infra-red Spectrometry (NIRS) in Infantile Epilepsy Spasms

Conditions
-----------------
Epilepsy

Intervention / Treatment
-----------------
* Device: NIRS


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children between 3 and 6 years old presenting infantile spasms according to the Classification of the International League Against Epilepsy Exclusion Criteria: Children younger than 3 months and older than 6 years of age, refusal of one of the parents, and dermatosis of the scalp

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 6 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 |
| --- | --- |
| NIRS<br>Near Infra Red Spectroscopy. | Device: NIRS<br>* Near Infra Red Spectroscopy<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| changes in HbO | hemodynamic changes in [HbO] before spasms, during spasms, and after spasms | Day 0 | 
| changes in Hbr | hemodynamic changes in [Hbr] before spasms, during spasms, and after spasms | Day 0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, spasms
Retrospective Analysis of PET Brain Imaging in Chronic Cancer Pain

Study Overview
=================
Brief Summary
-----------------
Cancer pain deteriorated in quality of life and related with numerous psychosocial problems. Over the one third of cancer patient suffered from moderate to severe cancer pain, even under adequate pain management. The 18F-fluoro-2-deoxyglucose (FDG) positron emission tomography/computed tomography (PET/CT) images can provide quantitative results in clinical oncology. As a functional neuroimaging, the PET evidently provided anatomical activated regions, size, and spatial extent information. In this retrospective study, we use FDG-PET to investigate changes concerning the glucose metabolism in the brain with or without cancer pain.

Official Title
-----------------
FDG PET Imaging Study of Brain Metabolic Change in Chronic Cancer Pain Patient: a Retrospective Analysis

Conditions
-----------------
Cancer Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: cancer patient Exclusion Criteria: no brain metastasis

Ages Eligible for Study
-----------------
Minimum Age: 20 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 |
| --- | --- |
| with cancer pain<br> | |
| without cancer pain<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Find the location of brain metabolic changes, pain scale | This retrospective analysis only compare image and clinical record including pain scale | 12 months |
Escitalopram Combination Comparison Study for Adult Patients With Major Depressive Disorder

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the effectiveness, safety and tolerability of an escitalopram combination treatment compared to single treatments, and to placebo in patients with major depressive disorder.

Detailed Description
-----------------
Both active drugs being tested, alone and in combination, in this study are currently available antidepressants. However, the doses used in this study are lower than the standard approved doses.

Official Title
-----------------
Fixed Dose Comparison of Escitalopram Combination in Adult Patients With Major Depressive Disorder

Conditions
-----------------
Major Depressive Disorder

Intervention / Treatment
-----------------
* Drug: Escitalopram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients must meet Diagnostic and Statistical Manual, Fourth Edition (DSM-IV) diagnostic criteria for Major Depressive Disorder The patient's current depressive episode must be at least 12 weeks in duration. Exclusion Criteria: Women who are pregnant, women who will be breastfeeding during the study, and women of childbearing potential who are not practicing a reliable method of birth control. Patients who currently meet DSM-IV criteria for : a. bipolar disorder; b. schizophrenia or any psychotic disorder; c. obsessive-compulsive disorder; d. mental retardation or any pervasive developmental disorder or cognitive disorder. Patients who are considered a suicide risk. Patients with a history of seizure disorder, or any history of seizure, stroke, significant head injury, or any other condition that predisposes toward risk of seizure.

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

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

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: Escitalopram|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery Asberg Depression Rating Scale (MADRS) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Depression Rating Scale (HAMD) |  |  |
Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence

Study Overview
=================
Brief Summary
-----------------
The goal of this study is to collect post-market data for the Ion Endoluminal System to understand CT to body divergence.

Official Title
-----------------
Prospective Post-market Data Collection for Ion Endoluminal System to Understand CT to Body Divergence

Conditions
-----------------
Lung Cancer, Pulmonary Nodule, Solitary

Intervention / Treatment
-----------------
* Device: Ion Endoluminal System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age of 18 years or older Undergoing a lung biopsy procedure with Ion System Have peripheral pulmonary lesion (5th bronchial generation or higher) Willingness to participate as demonstrated by signing the informed consent Exclusion Criteria: Unable to provide informed consent Presence of bilateral nodules intended to be biopsied during procedure The presence of medical conditions contraindicating general anesthesia or bronchoscopic biopsy Vulnerable population (e.g., prisoners, mentally disabled)

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 |
| --- | --- |
| Subjects with planned Ion Endoluminal Procedure with pulmonary nodule<br> | Device: Ion Endoluminal System<br>* Ion Endoluminal Procedure for pulmonary nodule<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ion Catheter Shape | The collection of data relating to the Ion catheter shape | Intra-operative |