linjc16/ctgov huggingface dataset:
LTS of Siliq vs. Other Therapies Treating of Adults With Moderate-to-Severe Psoriasis

Study Overview
=================
Brief Summary
-----------------
Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis

Detailed Description
-----------------
Prospective, Observational Study to Assess the Long-Term Safety of Brodalumab Compared with Other Therapies in the Treatment of Adults with Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care

Official Title
-----------------
Prospective, Observational Study Brodalumab Compared With Other Therapies in the Treatment of Adults With Moderate-to-Severe Psoriasis Who Are Candidates for Systemic Therapy or Phototherapy in the Course of Actual Clinical Care

Conditions
-----------------
Psoriasis

Intervention / Treatment
-----------------
* Biological: Brodalumab
* Drug: Comparator Drug (non-biologic IL-17 inhibitors)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis and main criteria for inclusion: a subject must have moderate to severe psoriasis diagnosed by a dermatologist Must be at least 18 years of age or older Started on or switched to a systemic psoriasis treatment within the previous 12 months. FDA-approved biologic treatments and select non-biologic treatments (eg, methotrexate, cyclosporine, or apremilast only) are permitted. Exclusion Criteria: The subject is unable or unwilling to provide informed consent to participate in the registry. The subject is participating or planning to participate in a clinical trial with a non-marketed or marketed investigational drug (i.e. Phase I-IV drug trial). The subject is restarting the eligible medication less than 12 months since receiving the last dose.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 99 Years

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Brodalumad exposed<br>1500 subjects exposes to brodalumab | Biological: Brodalumab<br>* Brodalumab<br>|
| Comparator Subjects<br>2000 comparator subjects | Drug: Comparator Drug (non-biologic IL-17 inhibitors)<br>* Comparator subjects treated with non-biologic IL-17 inhibitors<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the incidence of malignancy | Assess the incidence of malignancy, excluding non-melanoma skin cancer (NMSC), in adult psoriasis subjects exposed to brodalumab in the course of actual clinical care compared to non-IL-17-inhibitor biologic medications used to treat psoriasis. | 8 years |
A Phase II Study to Evaluate the Effects of Oral ONO-5129 in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The objectives of this study are to characterize the pharmacodynamic profile, safety and tolerability of ONO-5129 in patients with Type 2 Diabetes mellitus

Official Title
-----------------
Randomized Double-Blind Placebo-Controlled Pharmacodynamic Evaluation of ONO-5129 in Patients With Treatment Naive Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: ONO-5129


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Type 2 Diabetes Mellitus FBG level > 140 mg/dL and < 270 mg/dL Fasting TG level < 500 mg/dL BMI of 22 to 40 kg/m2, inclusive Other Inclusion criteria as specified in the study protocol Exclusion Criteria: Previous participation in an ONO-5129 protocol Previous treatment with TZD agents or other current antidiabetics History of myocardial infarction, coronary artery surgery, atrial/ventricular tachycardia, or atrial/ventricular fibrillation in the past six months Presence of functional limitations due to cardiovascular disease in accordance with the New York Heart Association Classification System - Class III (moderate) or IV (severe) Other exclusion criteria as specified in the study protocol

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

| Intervention/Treatment |
| --- |
|Drug: ONO-5129|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fasting Blood Glucose at 8 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacodynamic parameters at all time points |  |  |
Pool-based Exercise in Fibromyalgia Management

Study Overview
=================
Brief Summary
-----------------
Pharmacologic treatment remains the primary therapeutic approach in fibromyalgia management, but different non-pharmacologic measures, especially physical therapies and psychologically-based interventions, have also shown to be effective in the treatment of this disease. The objective of the present randomized controlled trial is to compare the efficacy and tolerability of two different modalities of active low-impact exercise in warm water: stretching and Ai Chi. Each group of patients will receive 18 physiotherapy sessions lasting 60 minutes and will be evaluated at baseline, at treatment termination, and after 4 and 12 weeks of follow up. Main outcome measures are the Fibromyalgia Impact Questionnaire (FIQ) and the Pittsburgh Sleep Quality Index (PSQI). Secondary outcome measures include the Beck Depression Inventory (BDI), the State and Trait Anxiety Inventory (STAI), and the SF-12 Health Survey (SF-12. Data analysis will be done using repeated measures ANOVA, unpaired Student's t test, and effect sizes' estimation (ES).

Official Title
-----------------
Pool-based Exercise in Fibromyalgia Management: a Prospective Randomized Comparison Between Stretching and Ai Chi

Conditions
-----------------
Fibromyalgia

Intervention / Treatment
-----------------
* Other: physical therapy
* Other: physical therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: diagnosis of fibromyalgia according to the ACR criteria 18 years or older written informed consent to participate Exclusion Criteria: unable to tolerate warm chlorinated water associated medical condition contraindicating exercise in warm water

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br> | Other: physical therapy<br>* physical therapy in warm pool performing stretching<br>|
| Experimental: 2<br> | Other: physical therapy<br>* physical therapy in warm pool performing Ai Chi<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in fibromyalgia symptomatology |  | 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in sleep, depressive and anxiety symptomatology and quality of life |  | 18 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
fibromyalgia, pool-based exercise
Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Study Overview
=================
Brief Summary
-----------------
Parallel group double blind randomised in patients with first episode corticosteroid sensitive nephrotic syndrome comparing time to relapse and adverse effects associated with a longer tapering steroid regimen with standard regime

Official Title
-----------------
Long Term Tapering or Standard Steroids for Nephrotic Syndrome

Conditions
-----------------
Nephrotic Syndrome

Intervention / Treatment
-----------------
* Drug: long term tapering of prednisolone
* Drug: standard prednisolone treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: newly presenting nephrotic syndrome, urine albumin/protein creatinine ratio >200mg/mmol on early morning urine sample, hypoalbuminemia (<25g/L) Exclusion Criteria: prior treatment with steroids or cytotoxic agents underlying systemic disorder or exposure to agents known to be associated with newly presenting steroid sensitive nephrotic syndrome

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 15 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

| Intervention/Treatment |
| --- |
|Drug: long term tapering of prednisolone|60mg/m2/day (0-4 weeks); 60mg/m2 alternate days (5-6 weeks); 50mg/m2 alternate days (week 7-8); 40mg/m2 alternate days (week 9-10); 30mg/m2 alternate days (week 11-12); 20mg/m2 alternate days (week 13-14); 10mg/m2 alternate days (week 15-16)|
|Drug: standard prednisolone treatment|60mg/m2/day week 0-4; 40mg/m2 on alternate days week 5-8|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to first relapse |  | 5 months | 
| Assessment of steroid induced morbidity |  | 5 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| frequent relapsing and steroid dependant disease |  | 5 months | 
| Time to relapse |  | 5 months | 
| serious adverse events |  | 5 months | 
| use of other immunosuppressive agents |  | 5 months | 
| Achenbach child behaviour checklist |  | 5 months |
Multifocal Electroretinography Before and After Silicone Oil Removal

Study Overview
=================
Brief Summary
-----------------
This is a prospective observational study to investigate the changes in multifocal electroretinogram signal before and after silicone oil removal in silicone-filled eyes.

Official Title
-----------------
Multifocal Electroretinography Before and After Silicone Oil Removal

Conditions
-----------------
Silicone Oil Filled Eyes

Intervention / Treatment
-----------------
* Diagnostic Test: Multifocal electroretinogram


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients 18 years of age or older who underwent pars plana vitrectomy for the repair of rhegmatogenous retinal detachment (RRD) and received silicone oil as an intraocular tamponade. Exclusion Criteria: Patients will be excluded if they have a significant corneal opacity, uncontrolled intraocular pressure, a confounding macular pathology or optic nerve pathology or if silicone oil has been in the eye for longer than 6 months.

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 |
| --- | --- |
| Silicone-filled eyes<br> | Diagnostic Test: Multifocal electroretinogram<br>* A device that records electric potentials generated by the retinal photoreceptors and neural elements in a multifocal fashion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Amplitude | Change in amplitudes of P1 and N1 waves before and after silicone oil removal | Preoperative and 1 month postoperative recordings |
Post-market Clinical Follow-up of Pfmmedical Ports

Study Overview
=================
Brief Summary
-----------------
Prospective, monocentric, non-randomised, observational post-market clinical follow-up study in Germany to obtain post-market information on the pfmmedical ports with a follow-up (FU) of 6 months. The focus is on patient reported satisfaction, clinical application, and complication rates.

Official Title
-----------------
Prospective, Monocentric Observational Study on the Clinical Use and Patient Satisfaction of Pfmmedical Implantable Vascular Access Ports

Conditions
-----------------
Vascular Access Port, Patient Satisfaction

Intervention / Treatment
-----------------
* Device: pfmmedical implantable vascular access ports


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: ≥ 18 years. Medical indication for port catheter implantation. The patient is mentally able to understand the nature, aims and possible consequences of the PMCF study. Patient information has been provided and written consent exists. Exclusion Criteria: Contraindications according to the manufacturer´s instructions for use (IFU). The patient is institutionalised by court or official order (MPDG §27). Patient participates in another operative clinical investigation if it relates to the area of port devices and/or influences the primary endpoint of the PMCF study. Patients who currently already have a port implanted.

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 |
| --- | --- |
| pfmmedical port implantation<br>Port implantation for continous vascular access. | Device: pfmmedical implantable vascular access ports<br>* Implantion of an implantable vascular access port which facilitates repeated vascular access intended for the delivery of medications, intravenous fluids, parenteral nutrition solutions or blood products and blood sampling using a Huber needle.<br>* Other names: T-Port Low Profile Contrast;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patients satisfaction | The study hypothesis is that the patients' satisfaction after the study intervention is not worse than the satisfaction identified in the current literature. Satisfaction is determined using the patient questionnaire (6 months after implantation). The following 4 domains of the validated questionnaire by Nagel et.al., 2012 are considered as relevant for the clinical outcome: Overall, how satisfied are you with the port system? In a similar situation, would you choose the port again? How satisfied are you with the cosmetic result? Does the port cause pain? | 6 months after port implantation |
Validation of a Hypertension Education Program

Study Overview
=================
Brief Summary
-----------------
The primary purpose of this study is to assess the effect of participating in the interactive hypertension education program of the German Hypertension League (DHL©) My blood pressure - OK! on office systolic blood pressure.

Official Title
-----------------
Validation of the Hypertension Education Program of the German Hypertension League (DHL©) My Blood Pressure - OK!

Conditions
-----------------
Arterial Hypertension

Intervention / Treatment
-----------------
* Behavioral: Interactive hypertension education program of the DHL©


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: > 21 years of age Primary arterial hypertension Office blood pressure between 140/90 mmHg and 160/100 mmHg Exclusion Criteria: Participation in another clinical study Unstable clinical condition Secondary arterial hypertension Dementia Major disability (modified Rankin-Scale > 4) Severe chronic kidney disease (serum creatinine > 2.0 mg/dL or estimated glomerular filtration rate < 40 ml/min/1.73m2) Liver disease including history of hepatic encephalopathy, esophageal varices or portacaval shunt History of gastrointestinal operation or disease with a potential influence on drug absorption Allergy or other contraindications against drugs given during the study History of non-compliance

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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Education program<br>Group of patients participating in the interactive hypertension education program of the DHL© My blood pressure - OK! | Behavioral: Interactive hypertension education program of the DHL©<br> <br> |
| No Intervention: Controls<br>Group of patients not participating in the interactive hypertension education program of the DHL© My blood pressure - OK! (usual care) | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office systolic blood pressure (mmHg) |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Office diastolic blood pressure (mmHg) |  | 6 months | 
| Self-measured systolic and diastolic blood pressure (mmHg) |  | 6 months | 
| 24-hour ambulatory blood pressure monitoring (mmHg) |  | 6 months | 
| Body Mass Index (kg per m2) |  | 6 months | 
| Physical activity (hours per week) |  | 6 months | 
| Alcohol consumption (drinks per week) |  | 6 months | 
| Quality of life based on the Quality of Life Questionnaire The Short Form 36 Health Survey |  | 6 months | 
| Knowledge regarding arterial hypertension based on the DHL© Questionnaire |  | 6 months |
Use of Amnion on Partial Thickness Burns

Study Overview
=================
Brief Summary
-----------------
To determine if Amnion, used on partial thickness burn injuries would provide an improvement in rate of healing, pain control and scarring as compared to standard medical treatments.

Official Title
-----------------
Project Title The Treatment of Partial Thickness Burns: Treated Amnion Versus Currently in Use Topical Medications

Conditions
-----------------
Burn

Intervention / Treatment
-----------------
* Biological: Amnion
* Biological: Amnion
* Drug: Polysporin/Bacitracin/Mycostatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Partial thickness burn injury. >2% burn injury. Ages 0-100 years. Exclusion Criteria: Patients not expected to survive
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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Amnion with processing procedures involving the use of trypsin-Edetic Acid(EDTA) | Biological: Amnion<br>* Application of Amnion with processing procedures involving the use of trypsin-EDTA<br>|
| Experimental: 2<br>Amnion with processing procedures involving the use of Dispase II | Biological: Amnion<br>* Application of Amnion with processing procedures involving the use of Dispase II<br>|
| Active Comparator: 3<br>Prepared Antibiotic ointment Polysporin, Bacitracin and Mycostatin | Drug: Polysporin/Bacitracin/Mycostatin<br>* Application of Prepared antibiotic ointment: Polysporin, Bacitracin and Mycostatin combined<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of time to 95% healing of treated burn wounds |  | Assessment daily until 95 % healed | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay |  | Measured at hospital discharge | 
| Incidence of infection |  | Measure daily until complete wound healing | 
| Amount of daily pain until wound is healed with different treatments. |  | Daily until wound is completely healed. | 
| Amount of scaring with different treatments |  | From injury to 2 years post burn | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Burn, Partial thickness burn
Intramuscular Benzathine Penicillin Injection Procedure

Study Overview
=================
Brief Summary
-----------------
The aim of this study was the determination of the effect of applying VR and DC distraction methods on patients' pain and satisfaction levels during IM benzathine penicillin injection. The research hypothesis: Are Virtual Reality and Distraction Card effective in reducing pain due to injection of IM benzathine penicillin? Does the use of Virtual Reality and Distraction Card during the injection process of IM benzathine penicillin have an effect on patient satisfaction?

Official Title
-----------------
The Use of Virtual Reality and Distraction Cards to Reduce Pain During Intramuscular Benzathine Penicillin Injection Procedure in Adults: A Randomized Controlled Trial

Conditions
-----------------
Injection Site Discomfort

Intervention / Treatment
-----------------
* Other: Intramuscular Injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: agree to participate in the research, being over the age of 18, being native speaker, not having vision and hearing problems, being prescribed benzathine penicillin with a dose of 1.200.000 IU, being experienced of IM injection, not having IM injection for the last 1 month Exclusion Criteria: volunteers who have scar, incision, lipodystrophy, abscess, necrosis, hematoma, ecchymosis, infection, pain and paralysis at the VG site volunteers are excluded if the injection process cannot be performed at one time

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: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Virtual Reality<br> | Other: Intramuscular Injection<br>* Intramuscular Benzathine Penicillin Injection Procedure<br>|
| Experimental: Distraction Card<br> | Other: Intramuscular Injection<br>* Intramuscular Benzathine Penicillin Injection Procedure<br>|
| No Intervention: Control<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for pain measurement | (Minimum score: 0 ; Maximum score:10) Higher scores mean a worse outcome | 4 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analog Scale for satisfaction measurement (Minimum score: 0 ; Maximum score:10) | (Minimum score: 0 ; Maximum score:10) Higher scores mean a better outcome | 4 months |