linjc16/ctgov huggingface dataset:
Evaluation of Frequency Lowering Technique

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to examine two frequency lowering techniques in case of audibility, recognition, distinction, discriminability and sound quality.

Detailed Description
-----------------
This is a controlled, single blinded and randomised comparative study which is conducted monocentric at Hoerzentrum Oldenburg, Germany. The focus is to test two frequency lowering techniques with an amount of 30 moderate to severe, symmetrically sensorineural hearing impaired adult subjects. The subjects, all of them native German speakers, individually conduct a number of laboratory standard tests and home trials (questionnaires) during 6 months including seven appointments of 2 hours.

Official Title
-----------------
Evaluation of Frequency Lowering Technique

Conditions
-----------------
Hearing Loss

Intervention / Treatment
-----------------
* Device: hearing aid NaidaUP
* Device: hearing aid NaidaSP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: female and male adults (>18 years old) mild to severe Hearing Loss symmetric Hearing Loss german native speakers Exclusion Criteria: persons who are not able to attend multiple appointments persons who are not able to handle a hearing aid persons with a mental handicap persons with limited access to multiple hearing situations persons with psychological disease no acclimatization to hearing aids

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: hearing aid NaidaUP<br>Within subject design: compare frequency lowering one with frequency lowering two. | Device: hearing aid NaidaUP<br>* Standard Power Hearing instruments including different frequency lowering techniques<br>|
| Other: hearing aid NaidaSP<br>Within subject design: compare frequency lowering one with frequency lowering two. | Device: hearing aid NaidaSP<br>* Standard Power Hearing instruments including different frequency lowering techniques<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Audibility improvement (Delta of dB SPL thresholds) of high frequency sounds measured with a Phoneme Perception Test. |  | 6 months |
Laquinimod Phase IIa Study in Active Crohn's Disease

Study Overview
=================
Brief Summary
-----------------
The study aims to evaluate the safety and clinical effect of daily oral treatment of Laquinimod capsules in active moderate to severe Crohn's disease. This study will assess Laquinimod doses of 0.5mg /day to 2 mg/day in sequential dose groups (cohorts). Laquinimod is a novel immunomodulating drug which is currently in advanced stages of development by Teva Pharmaceuticals Ltd. for Multiple Sclerosis.

Official Title
-----------------
A Phase IIa, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Sequential Cohorts, Dose Range Finding Study to Evaluate the Safety, Tolerability and Clinical Effect of Escalating Doses of Laquinimod in Active Moderate to Severe Crohn's Disease.

Conditions
-----------------
Crohn's Disease

Intervention / Treatment
-----------------
* Drug: Laquinimod
* Other: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects diagnosed with Crohn's disease for at least 3 months prior to screening. Moderate to severe Crohn's disease patients as determined by the CDAI score Exclusion Criteria: Subjects who have had recent bowel surgery Subjects with clinically significant GI obstructive symptoms Subjects with a clinically significant or unstable medical or surgical condition Subjects with unstable doses of standard of care medications (5-ASA, antibiotics, oral corticosteroids, immunosuppressants ) Women who are pregnant or nursing or who intend to be during the study period. Women of child-bearing potential who do not practice an acceptable method of birth control

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Laquinimod<br>Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day (sequential cohorts) | Drug: Laquinimod<br>* Laquinimod 0.5mg/day, 1mg/day, 1.5mg/day, 2mg/day, oral, for 8 weeks of treatment<br>|
| Placebo Comparator: Placebo<br>Matching placebo | Other: placebo<br>* Matching placebo for 8 weeks of treatment<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, Tolerability, Clinical Effect - proportion of subjects in clinical remission, proportion of subjects who respond to treatment. |  | 8 weeks |
A Two-Arm Study Comparing the Analgesic Efficacy and Safety of Acetaminophen and Tramadol Combination BID Versus Placebo for the Treatment of Acute Low Back Pain

Study Overview
=================
Brief Summary
-----------------
A multi-center placebo controlled, double-blind, trial comparing the analgesic efficacy and safety of Acetram Contramid® BID versus placebo for the treatment of acute low back pain in patients between 18 and 80 yrs of age.

Conditions
-----------------
Acute Low Back Pain

Intervention / Treatment
-----------------
* Drug: Combination drug (Acetaminophen + Tramadol)
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males or females in generally good health aged 18-80 years with moderate to severe acute low back pain. Current acute low back pain episode within 48h prior to study entry. Pain must be moderate to severe following incident Exclusion Criteria: Chronic low back pain Ongoing or history of alcohol or drug abuse Body Mass Index greater 39 Treatment within the last 3 weeks with monoamine oxidase inhibitors; tricyclic antidepressants and other tricyclic compounds; neuroleptics; selective serotonin reuptake inhibitors Known history or symptoms suspicious for cancer Significant renal or liver disease Spinal surgery within 1 year of study entry. Subjects who are pregnant or lactating. Subjects with unstable medical disease. Subjects who have received treatment with an investigational product/device with 30 days prior to study entry.

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Drug: Combination drug (Acetaminophen + Tramadol)<br> <br> |
| Placebo Comparator: 2<br> | Drug: Placebo<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain Intensity change from Baseline |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall satisfaction with the study medication |  |  | 
| Safety evaluation |  |  |
Open Surgery for Necrotizing Pancreatitis

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of the cases of traditional open surgery for acute necrotizing pancreatitis, with evaluation of indications for surgery, intraoperative findings, mortality rate and risk factors of mortality.

Detailed Description
-----------------
All cases of laparotomy/lumbotomy will be retrospectively analysed, with evaluation of mortality, complications, in-hospital stay, indications for surgery, findings during operation, combination with minimally invasive procedures (radiological drainage, necrosectomy). Assessment of risk factors, like erosive bleeding, intraperitoneal perforation of collection, gut resection, splenectomy, relaparotomy will be done.

Official Title
-----------------
Open Surgery for Necrotizing Pancreatitis in the Era of Minimally Invasive Approach: 10-year Experience in a High-volume Centre

Conditions
-----------------
Pancreatitis,Acute Necrotizing

Intervention / Treatment
-----------------
* Procedure: laparotomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: laparotomy or lumbotomy performed for acute necrotizing pancreatitis from January, 2008 to December, 2017 Exclusion Criteria: N/A

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 |
| --- |
|Procedure: laparotomy|Any open procedure such as laparotomy or lumbotomy for acute necrotizing pancreatitis will be evaluated, with assessment of results, complications and deaths|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival | patient's discharge from the hospital | 01.001.2008 - 31.12.2017 | 
| death | patient's death after the surgery | 01.001.2008 - 31.12.2017 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
necrotizing pancreatitis, laparotomy, debridement
U/S Guided vs. Traditional Palpation for Radial Artery Cannulation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to compare the efficacy of ultrasound- guided with the traditional palpation radial artery cannulation in critically ill children.

Detailed Description
-----------------
Arterial catheterization is often performed in critically ill patients for continuous hemodynamic monitoring and blood sampling. However, insertion of radial artery catheter with traditional palpation may be technically challenging, particularly in pediatric patients. There are few published studies on the use of ultrasound guidance for radial-artery catheter placement and mostly they were elective surgery children which received inhalation or deep sedative medication. Recently no setting published in pediatric intensive care unit.

Official Title
-----------------
Ultrasound-guided Compared With Traditional Palpation Radial Artery Cannulation in Critically Ill Children

Conditions
-----------------
Critical Illness

Intervention / Treatment
-----------------
* Procedure: Ultrasound
* Procedure: traditional method


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pediatric patients who required radial artery cannulation for hemodynamic monitoring or frequent blood samples in intensive care unit Exclusion Criteria: Wound at area of cannulation Can not palpate or weak radial artery pulse

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound guided<br>Radial artery catheters will be placed with the assistance of bedside ultrasound. | Procedure: Ultrasound<br>* ultrasound at radial site and measure the size and depth of radial artery and perform radial artery cannulation<br>|
| Active Comparator: traditional method<br>Radial artery catheters will be placed by the palpation technique only. | Procedure: traditional method<br>* Radial artery catheters will be placed by the palpation technique only.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| first attempt success rate of radial artery catheter insertion |  | 5 minute | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time to success of radial artery catheter insertion |  | 15 minute |
Global Strain and Mechanical Dispersion May Predict Death and Ventricular Arrhythmias Better Than Ejection Fraction

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than ejection fraction(EF) in patients with myocardial infarction and heart failure regardless of cause.

Detailed Description
-----------------
The main aim of this study is to investigate if global strain and mechanical dispersion may predict death and ventricular arrhythmias better than left ventricular ejection fraction in patients with myocardial infarction and heart failure. In patients who receive internal cardioverter defibrillator(ICD) the main aim is to investigate if mechanical dispersion may predict ventricular arrhythmias better than EF. 3) No interventions,only evaluation of the measurements obtained with transthoracic echocardiography. 4) Follow up for 3 years, extended from 3 to 5 years.

Official Title
-----------------
Improved Prediction of Clinical Outcome With the Use of Global Strain and Mechanical Dispersion in Patients With Myocardial Infarction and Heart Failure

Conditions
-----------------
Left Ventricular Function Systolic Dysfunction

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients with myocardial infarction heart failure( defined as heart failure symptoms: reduced left ventricular function/ and or heart failure signs on chest x ray. planned for primary prophylactic ICD over 18 years of age Informed consent 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?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ventricular arrhythmia and death after acute myocardial infarction or heart failure. | Arrhythmic events during follow-up are defined as documented sustained ventricular tachycardia, ventricular fibrillation, and SCD. Survival is assessed by medical charts if patients are within the uptake area of the hospital and by the Norwegian death registry Folkeregisteret. | 5 years or more | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ejection fraction, Global Strain, Mechanical dispersion
Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma

Study Overview
=================
Brief Summary
-----------------
Though it is generally accepted that exposure to sunlight is a major causative factor for skin cancer, the risk for developing melanoma is not directly linked to sun exposure such as in non-melanoma skin cancer. Therefore, a dual pathway has been proposed, distinguishing melanoma that develops on skin that is chronically exposed to sunlight from those that occur on skin that is normally protected. The risk for each type of melanoma is believed to be determined in part by genetic factors. To define these markers reproducibly, the investigators plan to establish a large cohort with comprehensive information regarding sun sensitivity (skin type), history of experienced sun exposure, skin pigmentation phenotypes, total number of nevi, and other types of skin tumors in a central European population. The investigators will obtain blood from all participants for DNA as well as serum analyses. Based on the finding that genetic variants of the melanocortin-1 receptor (MC1R) gene, associated with red hair and fair skin, have been shown to be associated with increased risk for melanoma, particularly those harboring BRAF mutations, the investigators will now focus on the study of recently discovered genetic variants associated with pigmentation. Furthermore, the investigators will study the relation of these variants with oncogenic mutations of melanoma in BRAF, RAS and c-Kit. The study of other genetic variants will follow, once a sufficiently large cohort has been established to reveal an independent genetic risk factor in a multivariate analysis including potential covariates as mentioned above. The identification of genetic risk factors for melanoma will not only help identify individuals with increased risk but also improve our understanding of the molecular background of the development of melanoma.

Official Title
-----------------
Genetic Risk Factors and Acquired Oncogenic Mutations of Melanoma

Conditions
-----------------
Melanoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with or without melanoma Exclusion Criteria: HIV and Hepatitis C positive individuals.

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 |
| --- | --- |
| 1<br>melanoma patients | |
| 2<br>controls | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| melanoma |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| survival |  | 10 years |
Extension Study for 43USSA1705

Study Overview
=================
Brief Summary
-----------------
To evaluate the long-term safety of Sculptra Aesthetic as a single regimen for correction of Nasolabial Fold (NLF) contour deficiencies after changes in reconstitution and injection procedures compared to the approved label.

Official Title
-----------------
Open Label Extension Study for 43USSA1705 (A Randomized, Evaluator-blinded, Multi-center Study to Evaluate the Safety and Effectiveness of Sculptra Aesthetic for Correction of Nasolabial Folds)

Conditions
-----------------
Nasolabial Folds

Intervention / Treatment
-----------------
* Device: Sculptra Aesthetic 8 ml and Lidocaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Randomized to Sculptra Aesthetic 8ml reconstitution and successfully completed study 43USSA1705 Exclusion Criteria: Medical condition that in the opinion of the Investigator would make the subject unsuitable for inclusion Other condition preventing the subject from entering the study in the Investigator's opinion Participation in any interventional clinical study throughout the duration of the study

Ages Eligible for Study
-----------------
Minimum Age: 22 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational Arm in pivotal study- 43USSA1705<br>Injection with Sculptra Aesthetic reconstituted with 8ml Sterile Water for Injection | Device: Sculptra Aesthetic 8 ml and Lidocaine<br>* Treatment of nasolabial folds<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of adverse events collected throughout the study period |  | Baseline (initial treatment in pivotal study 43USSA1705) to Week 96 | 
| Intensity of adverse events collected throughout the study period |  | Baseline (initial treatment in pivotal study 43USSA1705) to Week 96 | 
| Time to onset of adverse events collected throughout the study period |  | Baseline (initial treatment in pivotal study 43USSA1705) to Week 96 | 
| Duration of adverse events collected throughout the study period |  | Baseline (initial treatment in pivotal study 43USSA1705) to Week 96 | 
| Change from baseline on both sides of the face as assessed by the Evaluator using the Wrinkle Assessment Scale (WAS) |  | Weeks 72 and 96 after Baseline | 
| Responder rate using the Global Aesthetic Improvement Scale (GAIS) |  | Weeks 72 and 96 after Baseline | 
| FACE-Q Appraisal of Lines: Nasolabial Folds Questionnaire |  | Weeks 72 and 96 after Baseline | 
| Subject satisfaction score using a 5-point subject satisfaction questionnaire |  | Weeks 72 and 96 after Baseline |