linjc16/ctgov huggingface dataset:
Urinary Sensor for Cystourethrography

Study Overview
=================
Brief Summary
-----------------
Evaluation of urinary sensor that will be activated by the urine during voiding cystourethrography in pediatric patients

Detailed Description
-----------------
It is of immense importance to perform fluoroscopy during voiding phase of VCUG (Voiding Cystourethrogram) procedures in order to rule out vesicourethral reflux. It is difficult to know exactly when a child will start voiding, so the child is intermittently imaged by fluoroscopy. Fluoroscopy involves radiation, and this we try to diminish as much as possible. We suggest application of small urinary sensor in the perineum of the patient, that will signal the beginning of urination, and only then fluoroscopy will begin. This urinary sensor should cut down substantially radiation dose to the patient.

Official Title
-----------------
Urinary Sensor for Cystourethrography

Conditions
-----------------
Radiation Dose During VCUG

Intervention / Treatment
-----------------
* Other: placebo
* Device: Urinary sensor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children referred for VCUG procedure at out department Exclusion Criteria: children with pacemakers decline to participate

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 10 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>with application of urinary sensor | Device: Urinary sensor<br> <br> |
| Placebo Comparator: B<br>without use of urinary sensor | Other: placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Radiation dose during VCUG procedure |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
VCUG, radiation dose, pediatric patients
The Effects of Transcranial Direct Current Stimulation on Central Pain in Patients With Spinal Cord Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the analgesic effect of transcranial direct current stimulation (tDCS) applied on motor cortex in patients with spinal cord injury who have chronic neuropathic pain.

Detailed Description
-----------------
anodal stimulation of the primary motor cortex (M1) anode electrode: C3 (EEG 10/20 system) cathode electrode: contralateral supraorbital area constant current of 2mA intensity for 20 min twice a day with a more than 4 hours interval during of 2 weeks (from Monday to Friday, total 20 treatment session)

Official Title
-----------------
The Analgesic Effect of Transcranial Direct Current Stimulation Over the Primary Motor Cortex on Central Neuropathic Pain Patients With Spinal Cord Injury

Conditions
-----------------
Neuropathic Pain, Spinal Cord Injury

Intervention / Treatment
-----------------
* Device: transcranial direct current stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: elapsed time since spinal cord injury more than 6 months stable chronic pain for at least 3 preceding months pain that was not attributable to cause other that neuropathic pain pain that was resistant to various types of medications or physical or complementary medicine treatment Exclusion Criteria: any kind of metal implant in the head heart disease including having a cardiac maker family or personal history of epilepsy, or neuropsychiatric illness

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 60 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: transcranial direct current stimulation<br>Anodal stimulation on motor cortex | Device: transcranial direct current stimulation<br> <br> * Other names: Iomed Phoresor II Auto;|
| Sham Comparator: Sham transcranial direct current stimulation<br>Turn off after 10 s of stimulation | Device: transcranial direct current stimulation<br> <br> * Other names: Iomed Phoresor II Auto;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Numeric rating scale for average pain over the preceding 24h |  | before the first tDCS session, and 1, 2, 4, 6 and 8 wk after the start of the stimulation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient global impression of change for pain |  | before the first tDCS session, and 1, 2, 4, 6, and 8 wk after the start of the stimulation |
Respiratory Muscle Dysfunction in Critically Ill Patients

Study Overview
=================
Brief Summary
-----------------
Respiratory muscle dysfunction in critically ill patients is associated with elevated morbidity, including prolonged weaning from mechanical ventilation. The causes for respiratory muscle dysfunction in these patients is poorly understood and no effective treatment is available. The general hypothesis of the present study is that in critically ill mechanically ventilated subjects respiratory muscle dysfunctions results from loss of myosin induced by activation of proteolytic cascades.

Conditions
-----------------
Sepsis, Mechanical Ventilation

Intervention / Treatment
-----------------
* Procedure: diaphragm muscle biopsy
* Procedure: Diaphragm muscle biopsy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe sepsis / septic shock Clinical reason for laparotomy > 18 years Exclusion Criteria: No informed consent Medical history of myopathy Unintended weight loss before ICU admission Pregnancy Chronic use of corticosteroids

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diaphragm muscle biopsy<br>Patients admitted to the ICU meeting severe sepsis / septic shock criteria | Procedure: diaphragm muscle biopsy<br>* Biopsy is obtained for biochemical analysis<br>|
| Active Comparator: Elective laparotomy<br> | Procedure: Diaphragm muscle biopsy<br>* Biopsy is obtained for biochemical analysis<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diaphragm muscle myosin content |  | 1 day | 
| Markers for inflammation | Inflammatory mediators are measured in plasma and diaphragm at the moment the diaphragm biopsy is obtained. | 1 day | 
| Markers for activation of proteolytic pathway in the diaphragm | Biochemical analysis is targeted towards activation of several proteolytic pathways (proteasome, lysosmal). | 1 day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| length of ICU stay | Length of ICU stay obtained from medical record | 6 months | 
| Length of mechanical ventilation | Duration of mechanical ventilation is assesssed within 6 months after obtaining diaphragm biopsy. | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory muscle, Myosin, Mechanical ventilation
Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Study Overview
=================
Brief Summary
-----------------
This registry is performed for the long-term assessment of outcome, performance and residual safety aspects of the BIOMONITOR III and possible successors in a real-life clinical set-up. In addition, this registry is set up in a way that it may also be used as a platform for submodules to investigate additional scientific and regulatory aspects while minimizing the additional effort for the investigational sites and patients.

Official Title
-----------------
BIO|STREAM.ICM: Observation of Clinical Routine Care for Patients With BIOTRONIK Implantable Cardiac Monitors (ICMs)

Conditions
-----------------
Tachycardia, Atrial Fibrillation, Syncope, Bradycardia, Cryptogenic Stroke

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient is intended to receive a BIOTRONIK Implantable Cardiac Monitor (ICM) Patient is able to understand the nature of the registry and to provide written informed consent. Patient is willing and able to use the CardioMessenger and accepts the BIOTRONIK Home Monitoring concept. Exclusion Criteria: Patient is pregnant or breast feeding. Patient is less than 18 years old. Patient is participating in another interventional clinical investigation other than the submodules of BIO|STREAM.ICM

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| Time to diagnosis | Device is intended to detect rare arrhythmias. Time to detect this relevant arrhytmia will be recorded. | Data will be collected throughout the entire registry, i.e. until February 2023 (Last patient out). | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Insertion procedure and success | Information on the Insertion procedure (Operation time, handling of the BIOMONITOR incl. incision and inserton tool); Success rate of insertions. | It is considered that all patients are enrolled and subsequently inserted with the investigational device within 2 years after study start, i.e. until October 2021. Exchanges will be also considered for analysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BIOMONITOR III, Implantable Cardiac Monitor
Radiographic and Clinical Outcomes of PureGen in Posterior Lumbar (PLIF) and Transforaminal Interbody Fusion (TLIF)

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess the safety and efficacy of PureGen Osteoprogenitor Cell Allograft in patients undergoing Posterior Lumbar or Transforaminal Interbody Fusion.

Official Title
-----------------
Radiographic and Clinical Outcomes of PureGen Osteoprogenitor Cell Allograft in Posterior Lumbar and Transforaminal Interbody Fusion Procedures

Conditions
-----------------
Lumbar Degenerative Disc Disease

Intervention / Treatment
-----------------
* Biological: PureGen Osteoprogenitor Cell Allograft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with back and/or leg pain electing to receive Transforaminal Lumbar Interbody Fusion (TLIF)/ Posterior Lumbar Interbody Fusion (PLIF) procedure and posterior transpedicular stabilization with or without decompression at any level Unresponsive to conservative treatment for at least 6 months Radiographic confirmation of primary diagnosis Exclusion Criteria: More than 2 levels requiring lumbar interbody fusion Spondylolisthesis greater than Grade I Prior failed fusion surgery at any lumbar level(s) Local or systemic infection past or present Active systemic disease Osteoporosis, osteomalacia, or other metabolic bone disease that would significantly inhibit bone healing BMI greater than 40 Use of other bone graft, Bone Morphogenetic Protein (BMP) or bone graft substitutes in addition to or in place of those products specified Use of post operative Spinal Cord Stimulator (SCS) Any condition requiring postoperative medications that inhibit fusion, such as chronic use of oral or injected steroids or prolonged use of non-steroidal anti-inflammatory drugs Known or suspected history of alcohol and/or drug abuse Involved in pending litigation or worker's compensation related to the spine Pregnant or plans to become pregnant during the course of the study Insulin-dependent diabetes mellitus Known sensitivity to device materials Life expectancy less than duration of study Any significant psychological disturbance that could impair consent process or ability to complete self-assessment questionnaires Undergoing chemotherapy or radiation treatment Known history of hypersensitivity or anaphylactic reaction to dimethyl sulfoxide (DMSO)

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 |
| --- | --- |
| Lumbar Degenerative Disc Disease<br> | Biological: PureGen Osteoprogenitor Cell Allograft<br>* PureGen Osteoprogenitor Cell Allograft.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fusion | Proportion of subjects with fusion at the 24 month visit | 24 months |
Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish the single and multiple-dose pharmacokinetics (PK) of sublingual administration of the Sufentanil Sublingual Microtablet (SSM) 30 mcg and compare the pharmacokinetics of a single dose of SSM 30 mcg to 2 doses of SSM 15 mcg administered 20 minutes apart.

Official Title
-----------------
Pharmacokinetics of Sufentanil Sublingual Microtablet 30 mcg and 15 mcg in Healthy Subjects

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

Intervention / Treatment
-----------------
* Drug: Treatment Arm A: Sufenta®
* Drug: Treatment B: Sufentanil SSM 30 mcg
* Drug: Treatment C: SSM 15 mcg
* Drug: Treatment D: SSM 30 mcg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-smoking male or female subjects Aged between 18 and 45 years inclusive Subjects must have Body Mass Index (BMI) between 18 and 30, inclusively. Exclusion Criteria: Subjects who are taking over-the-counter medication (except for single dose multi-vitamin supplements or acetaminophen of less than 2 g/day) within 14 days prior to start of sufentanil dosing prescription medications or over the counter (OTC) medications Female subjects who are pregnant Subjects with chronic obstructive pulmonary disease, sleep apnea, or other significant respiratory disorders

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

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

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment A<br>Sufenta® IV (50 mcg/mL) 30 mcg infused over 1 minute | Drug: Treatment Arm A: Sufenta®<br>* Sufenta® intravenous (IV) (50 mcg/mL) 30 mcg infused over 1 minute<br>|
| Experimental: Treatment B<br>Single dose of SSM 30 mcg | Drug: Treatment B: Sufentanil SSM 30 mcg<br>* single-dose SSM 30 mcg<br>|
| Experimental: Treatment C<br>2 consecutive doses of SSM 15 mcg administered 20 minute apart | Drug: Treatment C: SSM 15 mcg<br>* 2 consecutive doses of SSM 15 mcg administered 20 minutes apart<br>|
| Experimental: Treatment D<br>12 consecutive doses of SSM 30 mcg administered 1 hour apart | Drug: Treatment D: SSM 30 mcg<br>* 12 consecutive doses of SSM 30 mcg administered 1 hour apart<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area Under the Curve | Area under the plasma concentration time curve | 9 days, not including a 30 day screening window | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Plasma concentrations
Turbinate Cauterization in Pediatric Patients With Nasal Obstruction

Study Overview
=================
Brief Summary
-----------------
patients will be placed in 2 groups, with or without turbinate cautery ( a surgical method to reduce the size of the skin covered bones in the nose), at the time of adenoidectomy and tonsillectomy. It will compare the amount of nasal congestion for each group with the idea that it will be less if treated with turbinate cauterization. Assessments from baseline to 6 months post procedure will be compared between the two groups.

Detailed Description
-----------------
To assess if inferior turbinate cautery improves nasal obstruction in children undergoing adenotonsillectomy.

Official Title
-----------------
Turbinate Cauterization in Pediatric Patients With Nasal Obstruction A Randomized Prospective Trial

Conditions
-----------------
Sleep Apnea, Nasal Obstruction

Intervention / Treatment
-----------------
* Procedure: turbinate cauterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ages 3-16 obstructive sleep apnea warranting adenotonsillectomy history of daytime nasal obstruction and or mouth breathing failed medical treatment with either oral anti-histamine or nasal steroid spray. turbinate hypertrophy on Physical Exam defined by >50% obstruction Exclusion Criteria: <3 or >16 unwillingness to comply with study procedures congenital head and neck malformations, genetic syndromes, craniofacial anomalies no evidence of turbinate hypertrophy or symptoms of nasal obstruction pregnancy or breastfeeding bleeding disorders current therapy with coumadin or Pradaxa

Ages Eligible for Study
-----------------
Minimum Age: 3 Years
Maximum Age: 16 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: Turbinate Cauterization<br>Turbinate Cauterization will be completed. | Procedure: turbinate cauterization<br> <br> |
| No Intervention: control<br>no turbinate cauterization | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| # of participants with improved nasal obstruction score from baseline to 6 months | Baseline assessment compared to 6 mo post surgery. The SN-5 Nasal Obstruction and Sinonasal Quality of Life instrument tools will be used to record nasal obstruction symptom scores. | baseline and 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
nasal obstruction
Impact of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate anti-oxidative and anti-inflammatory effects of pitavastatin in hypercholesterolemic patients with the metabolic syndrome.

Detailed Description
-----------------
The metabolic syndrome is defined as a cluster of cardiovascular risk factors including visceral obesity, dyslipidemia, elevated blood pressure and impaired glucose tolerance. Recently, it has been described that oxidative stress and inflammatory reaction, which are important in progression of atherosclerosis, increases in individuals with the metabolic syndrome. Statins might have beneficial effects such as anti-oxidative and anti-inflammatory actions that are independent from their cholesterol-lowering effects. Pitavastatin, a chemically synthesized statin, has potent LDL-cholesterol lowering and also anti-oxidative and anti-inflammatory effects in animal studies. However, the effects of pitavastatin on oxidative stress and inflammatory action in patients with the metabolic syndrome have not been reported.

Official Title
-----------------
Multicenter Study for Anti-oxidative and Anti-inflammatory Effects of Pitavastatin in Hypercholesterolemic Patients With Metabolic Syndrome

Conditions
-----------------
Metabolic Syndrome, Oxidative Stress, Inflammation

Intervention / Treatment
-----------------
* Drug: pitavastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Hypercholesterolemic patients Exclusion Criteria: Patients receiving lipid-lowering agents Familial hypercholesterolemia Renal disease Diseases of liver, gallbladder and bile ducts Pregnant women

Ages Eligible for Study
-----------------
Minimum Age: 20 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: pitavastatin|Pitavastatin (2mg/day) was administered for 12 weeks|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thiobarbituric acid reactive substance; high sensitive C-reactive protein |  | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total cholesterol; LDL-cholesterol; HDL-cholesterol; triglyceride; |  | 12 weeks | 
| Homeostasis model assessment for insulin resistance; adiponectin; |  | 12 weeks | 
| Soluble intercellular adhesion molecule-1 |  | 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
statin, metabolic syndrome, oxidative stress, inflammation