linjc16/ctgov huggingface dataset:
Validation of Kujala German

Study Overview
=================
Brief Summary
-----------------
The field of patellofemoral disorders and accordant therapeutical interventions is a high turnover research field. It is important to verify the clinical outcome with appropriate measuring tools. There is evidence that the Kujala score is a reliable and widely used measuring instrument of patellofemoral disorders. Indeed, the Kujala score was already used in many studies investigating patellofemoral disorders - also in german speaking patient groups. Unfortunately, we are not aware of a validated german version of the Kujala score. Other relevant knee outcome scores were already successfully translated into german language and validated by previous investigators. So, it is the aim of our study to cross-culturally adapt and then to validate the Kujala score for use in German-speaking individuals with patellofemoral instability. It is hypothesized that the german version of the Kujala score shows: High divergent construct validity as determined by significant differences between patients and controls (hypothesis 1) High convergent construct validity as determined by significant correlations with other relevant scoring systems (hypothesis 2) High reliability (hypothesis 3) High responsiveness (hypothesis 4)

Official Title
-----------------
Cross-cultural Adaptation and Validation of the German Version of the Kujala Score in Patients With Patellofemoral Instability - a Prospective Multi-centric Study

Conditions
-----------------
Validation of Kujala Score German Version in Patients With Patellofemoral Instability and Scheduled MPFL-reconstruction

Intervention / Treatment
-----------------
* Procedure: MPFL- Reconstruction


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: german speaking MPFL-reconstruction planed Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 10 Years
Maximum Age: 70 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 |
| --- | --- |
| Patellofemoral Instability<br>Patients with diagnosis of patellofemoral instability receiving MPFL-reconstruction as part of the clinical routine | Procedure: MPFL- Reconstruction<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Kujala Score |  | 1 year | 
| KOOS (Knee Injury and Osteoarthritis Outcome Score) |  | 1 year | 
| Marx Activity Scale |  | 1 year | 
| SF-12 (Short - Form 12) |  | 1 year | 
| VAS pain |  | 1 year | 
| Lysholm Score |  | 1 year |
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association

Study Overview
=================
Brief Summary
-----------------
The goal of this project, is to better understand the fluctuation of the level of uric acid in traumatized patients by making serial measurements during their hospitalization in the intensive care unit. In addition, the determinants (e.g. type of trauma, diseases, interventions) of the blood level of uric acid and its association with the development of organ failure will be sought.

Official Title
-----------------
Pilot Study to Measure Uric Acid in Traumatized Patients: Determinants and Prognostic Association

Conditions
-----------------
Trauma, Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Direct admission to trauma center ≤ 3h after trauma ISS ≥ 16 Received at least 1L of fluid at ER entrance Exclusion Criteria: Isolated head injury Isolated spine injury Chemotherapy within the last month Hematologic disease Chronic hemodialysis Uricase treatment within the last week Expected death within 48h

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Feasibility of serial plasmatic uric acid sampling after trauma | Number of measures collected/number of measures planned | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of resuscitation on uric acid measures | Impact of fluid administration (amount in mL) on the changes of subsequent uric acid blood level | 24 to 48 hours | 
| Clinical predictors of the first blood uric acid (μmol/L) level measured | Impact of patient's characteristics and physiological variables on the first measured blood uric acid. Characteristics will include: age (years), gender, Injury severity score, presence of acute renal impairment. Physiological variables will include: lower systolic blood pressure, base deficit, lactate level | 12 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
uric acid, organ failure
Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

Study Overview
=================
Brief Summary
-----------------
In this project, the investigators aim to study the role of biliverdin reductase A (BLVRA) in HCV infected patients prior and during/after standard antiviral therapy in association with viral clearance, disease progression and treatment response and in comparison with healthy subjects.

Detailed Description
-----------------
To analyze biliverdin reductase (BLVRA) expression in the liver of HVC infected patients undergoing liver biopsy followed by standard antiviral treatment (peg-interferon plus ribavirin combination therapy) and patients with other forms of liver diseases undergoing liver biopsy as controls. To analyze BLVRA expression in peripheral blood leukocytes (PBL) of therapeutically naïve HCV patients, during/after standard antiviral therapy and healthy controls. To analyze BVLRA genetic polymorphisms both in HCV infected patients and healthy controls.

Official Title
-----------------
Biliverdin Reductase A in Chronic Hepatitis C Virus Infection

Conditions
-----------------
Hepatitis C, Chronic

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BLVRA expression study Therapeutically naïve HCV patients undergoing antiviral treatment with peg-interferon plus ribavirin combination therapy BLVRA genetic polymorphisms study HCV infected patients prior, during, after or without antiviral therapy Exclusion Criteria: Co-infection with HAV, HBV and HIV Disorders of heme metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| chronic HCV infection<br>The study was performed on therapeutically naïve patients with chronic HCV infection. Patients with positivity of anti-HCV antibodies, and detectable HCV RNA in serum for at least 6 months, were included in the study. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess differences in BLVRA expression in the liver and PBMC in HCV infected patients in responders and non-responders to standard antiviral therapy. |  | 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To analyze the association of genetic polymorphisms of BLVRA with disease progression and treatment response in HCV infected patients. |  | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
biliverdin reductase, BLVRA, hepatitis C, HCV, peripheral blood mononuclear cells, PBMC, liver, genetic polymorphisms
Minimal Invasive Versus Traditional Transgluteal Approach in Total Hip Arthroplasty: a Comparative Gait Analysis

Study Overview
=================
Brief Summary
-----------------
The hypothesis for the present study was that patients receiving a minimally invasive total hip arthroplasty will show a faster improvement on walking ability and mobilization in the immediate postoperative period compared to patients with the standard Hardinge approach. Therefore, the main goal was to evaluate the differences in early rehabilitation of these two different surgical approaches by gait analysis and electromyographical examination as objective methods.

Official Title
-----------------
Minimal Invasive Versus Traditional Transgluteal Approach in Total Hip Arthroplasty: a Comparative Gait Analysis

Conditions
-----------------
Total Hip Arthroplasty

Intervention / Treatment
-----------------
* Procedure: minimally invasive total hip arthroplasty
* Procedure: standard approach total hip arthroplasty


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: unilateral osteoarthritis of the hip BMI below 30 Exclusion Criteria: previous surgery on the evaluated hip, previous arthroplasties on other joints, a leg length discrepancy of more than 0.5cm, rheumatoid osteoarthritis decreased mobility due to non joint related factors
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>minimal invasive approach | Procedure: minimally invasive total hip arthroplasty<br>* minimally invasive total hip arthroplasty<br>|
| 2<br>traditional transgluteal approach | Procedure: standard approach total hip arthroplasty<br>* standard Hardinge approach/traditional transgluteal approach<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
gait analysis, minimal invasive approach, transgluteal approach, THA
Posterior Minimally Invasive Plate Osteosynthesis (MIPO) for Humerus Diaphyseal Fractures

Study Overview
=================
Brief Summary
-----------------
The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate.

Detailed Description
-----------------
The primary objective is to evaluate the clinical, functional and radiological results in patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate. Clinical Pain ROM Functional Constant Score MEPS QuickDASH Radiological - Bone union Complications Infection Nerve injury

Official Title
-----------------
Posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate

Conditions
-----------------
Humerus Fracture

Intervention / Treatment
-----------------
* Procedure: MIPO with Extra-articular Distal Humeral Anatomical Plate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Closed diaphyseal humerus fracture at the junction of the middle third with distal Exclusion Criteria: Open fractures, proximal humerus extension, distal articular compromise, polytrauma, more than 2 weeks of trauma

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 |
| --- | --- |
| Posterior MIPO<br>Patients treated with posterior MIPO for Humerus Diaphyseal Fractures With Extra-articular Distal Humeral Anatomical Plate | Procedure: MIPO with Extra-articular Distal Humeral Anatomical Plate<br>* MIPO with Extra-articular Distal Humeral Anatomical Plate<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone union | Radiological Bone union (X-ray or CT) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain (Quantity) | Visual Analog Scale | 1 month, 6 months, 1 year | 
| Range of Motion (Degrees of flexion, extension, pronation and supination) | Physical Exam | 1 month, 6 months, 1 year | 
| Constant Score | Score | 1 month, 6 months, 1 year | 
| Mayo Elbow Score | Score | 1 month, 6 months, 1 year | 
| Quick Disabilities of the Arm, Shoulder and Hand | Score | 1 month, 6 months, 1 year | 
| Radial nerve injury | Physical exam (electromyography when needed) | 1 month, 6 months, 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
humerus, fracture, osteosynthesis
Non-inferiority Clinic of Kollagenase® Compared Iruxol® in Treatment of Cutaneous Ulcers

Study Overview
=================
Brief Summary
-----------------
Skin ulcers can be defined as open injuries, loss of substances with the skin or mucous tissue, caused by disintegration and tissue necrosis. Chronic skin ulcer is any injury that heal in a period not less than 6 weeks. Several etiological causes for the emergence of skin ulcers. Around 73% are venous, arterial are 8%, 3% are diabetic, 2% are traumatic and 14% are from other causes. Clinical studies show that collagenase is an effective drug and presents high tolerabildade in the treatment of ulcerative burns and injuries of various etiologies. Evidence show statistically significant reduction of inflammation, the formation of granulation tissue, decrease in injuries and reepitelization.

Official Title
-----------------
Study of Non Inferiority of Product Kollagenase ®, Manufactured by Laboratory Cristália When Compared With Iruxol ®, Manufactured by Abbott Laboratory, in the Treatment of Cutaneous Ulcers

Conditions
-----------------
Ulcers

Intervention / Treatment
-----------------
* Biological: collagenase (IRUXOL)
* Biological: collagenase (Kollagenase)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both sexes aged over 18 years people with skin ulcers of the lower limbs for at least 3 months Exclusion Criteria: Lesion with a diameter larger than 12 cm ² injury over 2 years of evolution; injury infected neoplastic lesions in activity poorly controlled diabetes mellitus HAS poorly controlled signs of ischemia in the limb not offset any disease allergic to components of formula urticaria pregnancy breastfeeding emotional disturbance

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients treated with collagenase (IRUXOL) | Biological: collagenase (IRUXOL)<br>* patients will be treated with collagenase one time per day.<br>|
| Experimental: 2<br>patients treated with collagenase (Kollagenase) | Biological: collagenase (Kollagenase)<br>* patients will be treated with collagenase one time per day.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Primary: Non-inferiority based on efficiency that will be evaluated by the general improvement of the injury; Secondary: tolerability assessed by the incidence of adverse events. |  | healing | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Non-inferiority based on efficiency
Effects of OA Decompression on the Autonomic Nervous System

Study Overview
=================
Brief Summary
-----------------
This study was designed to determine whether a simple manipulative technique of relaxing the tissues of the occipito-atlantal junction in the neck had any effect on the activity of the sympathetic or parasympathetic nervous system. Subjects were dark adapted then measures of pupillary activity, reflecting autonomic nervous system activity were taken before and after treatment. The study hypothesis was that thet treatment technique would have no effect on the pupillary measures, hence indicating no effect on autonomic system activity.

Detailed Description
-----------------
This study was a within subjects/crossover design in which each subject received the treatment and served as his/her own control. 100 subjects were recruited from the student/staff population of the university, were 18 y/o or older with no condition affecting pupillary activity. Pupillary activity was measured with a PLR100 pupillometer and included pupillary diameter, pupillary response latency, maximum constriction velocity and maximum redilation velocity. Subjects were adapted to a dim light environment, measures taken, treatment given at either third or fourth time period and measures retaken. The study was approved by the NSU IRB. Subject numbers were sufficient to have statistical power to find an effect. The study found an effect of treatment on maximum size, showing a decrease with treatment.

Official Title
-----------------
Effects of OA Decompression on Activity of the Autonomic Nervous System

Conditions
-----------------
Muscle Tension

Intervention / Treatment
-----------------
* Procedure: OA decompression manipulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 y/o Normal accommodation and pupillary response Willing to undergo osteopathic manipulation Exclusion Criteria: Active ocular or systemic disease Neurologic disease that would alter pupillary response Chronic pain syndromes of head or neck Pregnant Brain injury Taking medications that would alter autonomic tone

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: OA decompression manipulation|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pupillary diameter |  |  | 
| pupillary latency |  |  | 
| pupillary constriction velocity |  |  | 
| pupillary redilation velocity |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
osteopathic manipulation, autonomic nervous system
Pilot Study of Somatostatin Receptor Imaging in Nasopharyngeal Cancer

Study Overview
=================
Brief Summary
-----------------
Hypothesis: To estimate the proportion of locally advanced, recurrent or metastatic nasopharyngeal cancer patients which show high somatostatin receptor density (SUVmax >10) on Ga-68 DOTATATE imaging. Galium-68 DOTATATE: PET imaging will be performed with a PET/CT scanner. Galium-68 DOTATATE will be injected intravenously. Scanning will be performed approximately 60 minutes after the injection. The standardized uptake value (SUV) will be used in the interpretation of the Ga-68 DOTATATE scans. The values gathered will be used as an estimate of the somatostatin receptor density. A patient will be considered to have an overall high somatostatin receptor density if the average SUVmax of all the representative lesions is more than 10.

Official Title
-----------------
Pilot Study of Somatostatin Receptor Imaging in Nasopharyngeal Cancer

Conditions
-----------------
Nasopharyngeal Carcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Locally advanced NPC or Metastatic NPC or locally recurrent NPC >21 years old Histological confirmation of NPC Exclusion Criteria: <21 years old Pregnancy or breast feeding

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- | --- |
| Number of NPC patients with high somatostatin receptor density | High somatostatin receptor density is when average maximum standardized uptake value (SUVmax) of all the representative lesions is more than 10 on Ga-68 DOTATATE imaging | 60 minutes |
Emergency Management of Minor Blunt Thoracic Trauma

Study Overview
=================
Brief Summary
-----------------
Thoracic traumas are frequent causes of emergency department admissions and the third most common cause of death from trauma. Although emergency management of major thoracic traumas that have high mortality and morbidity were discussed and well-understood in detail in the literature, there are limited information regarding diagnosis, emergency management, treatment and follow-up after discharge of patients with minor blunt thoracic traumas. The investigators aimed to investigate demographic data, physical examination findings, and the relationship between lung injury, emergency department final diagnosis, hospitalization, discharge and re-admission rates, effects of prescribed analgesics on pain and re-admissions of patients with a pre-diagnosis of minor blunt thoracic trauma on first admission.

Official Title
-----------------
To Review the Management and Follow-up of Patients With Minor Thoracic Injuries Treated by Emergency Physicians.

Conditions
-----------------
Thoracic Injuries,

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Glasgow Coma Scale (GCS) of 15 stable vital signs admitted within the first 6 hours after injury Exclusion Criteria: urgent and urgent triage category

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 |
| --- | --- |
| minor blunt thoracic trauma patient<br>demographic data, physical examination findings | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of lung injuries caused by minor thoracic traumas will be assessed by using questionnaire. |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
minor blunt thoracic trauma, physical examination