linjc16/ctgov huggingface dataset:
MiDura-Study (Neuro-Patch in Duraplasty)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to collect systematically and proactively data regarding the performance of Neuro-Patch, like complications and handling, under daily clinical practice when used as intended by the manufacturer

Official Title
-----------------
Multicenter, International, Prospective, Observational, Study Using Neuro-Patch® in Duraplasty in Neurosurgery (MiDura)

Conditions
-----------------
Chiari Malformation, Craniotomy, Meningioma, Tumor, Brain, Vascular Malformation, Hydrocephalus, Tethered Cord, Dural Fistula, Spinal Surgery, Duraplasty

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Written informed consent Age > 18 years Duraplasty using Neuro-Patch® according to the Instructions for Use Exclusion Criteria: Use in infected regions Use in open cerebrocranial traumata Use in open spina bifida Known hypersensitivity to implant materials Pregnancy Representation by a legal guardian or under involuntary commitment

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 |
| --- | --- |
| Neuro-Patch<br>Patients receiving Neuro-Patch® for duraplasty | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of complications | Incidence of complications, with (potential) causal relationship to Neuro-Patch | until follow-up (up to one year after surgery) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Handling measures | Evaluation of handling characteristics using a questionnaire containing 5-level Likert scales (excellent, very good, good, fair, poor) | Intraoperative | 
| Incidence of complications not related to Neuro Patch | Incidence of complications, without causal relationship to Neuro-Patch | until follow-up (up to one year after surgery) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
duraplasty, dural substitute, synthetic graft, Neuro-Patch®
Psychosocial, Environmental, and Chronic Disease Trends in Puerto Rico

Study Overview
=================
Brief Summary
-----------------
The overall goal is to identify trends and longitudinal associations in psychosocial, food-related, and cardiometabolic risk factors that can guide public health priorities and future research needs aimed at reducing cardiovascular-related disparities in Puerto Rico. To this end, investigators will establish 'PROSPECT: Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic disease Trends', an island-wide, longitudinal population cohort of 2,000 adults (30-75 years) in PR recruited with a community-wide sampling strategy, and assessed in a network of several partner clinics across the island. The study will collect comprehensive data on multiple psychosocial, dietary, and food-related factors, CVD biological markers, and medical record data, with follow-up at 2-years, and will assess variations by urban-rural area and by timing before-after Maria.

Official Title
-----------------
Puerto Rico Observational Study of Psychosocial, Environmental, and Chronic Disease Trends

Conditions
-----------------
Depressive Symptoms, Heart Diseases, Type2 Diabetes, Hypertension, Obesity, Dyslipidemias, Metabolic Syndrome, Cardiovascular Diseases, Chronic Disease, Inflammation, Psychological Stress, Physiological Stress, Coping Behavior, Diet Habit, Lifestyle

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 30-75 years old at the time of enrollment Non-institutionalized Living in PR at the time of the first interview and the year before and not planning to move from the island within 3 years Able to answer questions without assistance Living in a stable dwelling Exclusion Criteria:

Ages Eligible for Study
-----------------
Minimum Age: 30 Years
Maximum Age: 75 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with self-reported medically-diagnosed chronic diseases | Estimate the prevalence and incidence of chronic diseases (and their dietary and psychosocial risk factors) | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Difference in the number of participants with self-reported medically-diagnosed chronic diseases living urban vs. rural area | Estimate differences in prevalence and changes in chronic diseases (and their dietary and psychosocial risk factors) in urban vs. rural area | 4 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hispanics/Latinos, Minority health, Puerto Rico, Cardiovascular disease, Cardiometabolic health, Chronic disease risk factors, Disaster research, Caribbean and Latin America, Population health, Prospective study, Allostatic load
Outcome of Patients Treated With RRT

Study Overview
=================
Brief Summary
-----------------
Acute Kidney Injury (AKI) is a common serious complication after cardiac surgery. AKI not only prolongs the hospitalization time of patients undergoing cardiac surgery and increases the cost of treatment, but also is an independent risk factor for postoperative death. The aim of this study is to investigate the outcome of patients treated with renal replacement therapy (RRT), and to evaluate the short-term and long-term outcomes of patients with RRT.

Official Title
-----------------
Outcome of Patients Treated With Renal Replacement Therapy

Conditions
-----------------
Acute Kidney Injury, Cardiac Surgery

Intervention / Treatment
-----------------
* Procedure: Renal replacement therapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Critically ill patients undergoing cardiovascular surgery admitted to intensive care units. Patients receiving RRT for renal support Patients over 18 years of age Exclusion Criteria: Patients <18 years Refusal of consent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Renal replacement therapy|Renal replacement therapy (RRT) refers to modalities of treatment that are used to replace the waste filtering functions of a normal kidney.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| All-cause mortality |  | 30 days after Renal replacement therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ICU Length of Stay (LOS) |  | from ICU admission to ICU discharge, within 30 days of admission |
Cefazolin Subcutaneous Microdialysis in Morbidly Obese Patients

Study Overview
=================
Brief Summary
-----------------
The investigators hypothesize that cefazolin perfusion to subcutaneous adipose tissue is reduced in morbidly obese patients. The primary objective of this exploratory pilot study is therefore to investigate target site (subcutaneous adipose tissue) penetration of cefazolin in morbidly obese patients and non-obese patients. The investigators aim to examine whether and how cefazolin plasma concentrations are predictive of subcutaneous (target) cefazolin concentrations. Possible factors of influence on the distribution of cefazolin (tissue perfusion, body weight, distribution of adipose tissue, other) will be identified.

Official Title
-----------------
Peri-and Postoperative Subcutaneous Adipose Tissue Cefazolin Determination Using Microdialysis in Morbidly Obese and Non-obese Patients

Conditions
-----------------
Morbid Obesity

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Body Mass Index > 40 kg/m2 BMI between 20-25 undergoing laparoscopic gastric banding, or bypass surgery or sleeve gastrectomy (See population description for surgery type of the non-obese group) 21-60 years old American Society of Anaesthesiologists (ASA) physical status II to III Exclusion Criteria: pregnancy breastfeeding known allergy for cefazolin/nadroparin known ejection fraction of < 35% renal insufficiency

Ages Eligible for Study
-----------------
Minimum Age: 21 Years
Maximum Age: 60 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 |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cefazolin, microdialysis, morbid obesity, pharmacokinetics
Rituximab in Primary Lymphocyte Predominant Hodgkin´s Disease(RIPL)

Study Overview
=================
Brief Summary
-----------------
First line therapy for patients with Lymphocyte predominant Hodgkin´s Disease (LPHD) in clinical stage IA using the monoclonal anti-CD20 antibody rituximab

Official Title
-----------------
Rituximab in Primary LPHD (RIPL) - First Line Therapy for Patients With Lymphocyte Predominant Hodgkin´s Disease (LPHD) in Clinical Stage IA Using the Monoclonal Anti-CD20 Antibody Rituximab.

Conditions
-----------------
Lymphocyte Predominant Hodgkin´s Lymphoma (LPHD)

Intervention / Treatment
-----------------
* Drug: Rituximab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: lymphocyte predominant Hodgkin´s lymphoma (histologically proven) clinical stage IA (without risk factors: large mediastinal mass, extranodal involvement, ESR > 50mm/h) age 18 - 75 WHO performance status 0-3 normal organ function written informed consent Exclusion Criteria: classical Hodgkin´s lymphoma composite lymphoma leucocytes < 3000/µl thrombocytes < 100.000/µl

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: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Rituximab|nan|

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
-----------------
Lymphoma, LPHD, Rituximab
Validation of Ultra Sound (US) Elastography

Study Overview
=================
Brief Summary
-----------------
This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography of Patients referred to our institution to assess soft tissue and organ lesions. All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.

Detailed Description
-----------------
The investigators propose UltraSound Elastography as an imaging method which allows for a better evaluation of soft tissue and organ lesions compared to the conventional US modalities used nowadays in the dayly clinical routine. This is a prospective, single-center, non-randomised, non-blinded trial with US Elastography of Patients referred to our institution to assess soft tissue and organ lesions. All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed.

Official Title
-----------------
Validation of Ultra Sound (US) Elastography for the Evaluation of Soft Tissue and Organ Lesions

Conditions
-----------------
Soft Tissue Lesions

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient scheduled for clinically indicated conventional Ultrasound examination Exclusion Criteria: Age < 18 years

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 |
| --- | --- |
| UltraSound Patients<br>All patients will undergo next to the clinical indicated conventional US-examination, US Elastography after informed consent. After completion of these three examinations, the participation in the study is completed. | Device: Ultrasound<br>* Ultrasound Elastography of soft tissue and organ lesions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Inferiority to conventional Ultrasound (conv. US) | Value of US Elastography compared to conventional US | when scheduled for conv. US, 30minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Superiority to conventional Ultrasound (conv. US) | Value of US Elastography compared to conventional US | when scheduled for conv. US, 30minutes |
Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability

Study Overview
=================
Brief Summary
-----------------
Aim of this non-interventional study is to investigate the tolerability of Effentora® in cancer pain patients with breakthrough pain under real-life conditions in clinical practice.

Detailed Description
-----------------
In addition to the effectiveness of Effentora® therapy, safety, general feasibility and the impact of therapy on the patients' quality of life are of interest.

Official Title
-----------------
ERKENTNIS: Effentora® in Clinical Practice - a Non-interventional Study to Evaluate Satisfaction and Tolerability

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

Intervention / Treatment
-----------------
* Drug: Effentora®


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: decision to start treatment with Effentora prescription in accordance with Summary of Product Characteristics (SmPC) personally signed and dated Informed Consent document Exclusion Criteria: any subject considered unsuitable according to SmPC

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 |
| --- | --- |
| Effentora®<br>Single group prospective treatment cohort | Drug: Effentora®<br>* prescribed as per local Summary of Product Characteristics (SmPC) for 4 weeks duration<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pain relief | to show adequate pain relief within 10 minutes | 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| occurrence of adverse events | document the tolerability of Effentora® | 4 weeks | 
| Change in level of breakthrough pain | pursue the possible changes in the history of breakthrough pain during treatment with Effentora | 4 weeks | 
| presence of specific triggers for breakthrough pain | to investigate the presence of specific triggers (directly or indirectly) with breakthrough pain | 4 weeks | 
| quality of life | to document the impact of breakthrough pain in different areas of patients' lives and their changes during treatment with Effentora® | 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
breakthrough cancer pain
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Many people with type 2 diabetes cannot maintain their target blood glucose levels on a single therapy. This is a 28-week extension to a study to assess the safety and effectiveness of vildagliptin, an unapproved drug, in lowering overall blood glucose levels when added to insulin in people with type 2 diabetes who are not at target blood glucose levels on insulin alone. The purpose of the extension study is to gather data on the long-term safety and effectiveness of vildagliptin in people with type 2 diabetes.

Official Title
-----------------
Extension to a Study on the Efficacy and Safety of Vildagliptin in Combination With Insulin in Patients With Type 2 Diabetes

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

Intervention / Treatment
-----------------
* Drug: vildagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only patients successfully completing study CLAF237A2311 are eligible Written informed consent Ability to comply with all study requirements Exclusion Criteria: Premature discontinuation from CLAF237A2311 Other protocol-defined exclusion criteria may apply

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: vildagliptin|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of vildagliptin in combination with insulin during 52 weeks of treatment |  |  | 
| Change from baseline in HbA1c at 52 weeks |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in HbA1c between 24 weeks and 52 weeks |  |  | 
| Change in fasting plasma glucose between 24 weeks and 52 weeks |  |  | 
| Change from baseline in fasting plasma glucose at 52 weeks |  |  | 
| Change from baseline in mean daily insulin dose at 52 weeks |  |  | 
| Change from baseline in mean daily number of insulin injections at 52 weeks |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Type 2 diabetes, vildagliptin
To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia

Study Overview
=================
Brief Summary
-----------------
The primary objective is to survey the efficacy of various commercially available statins (a class of lipid-lowering agents, for example, rosuvastatin, atorvastatin, simvastatin, lovastatin, pravastatin and fluvastatin) under local clinical practice in treating patients with hyperlipidemia. Surveillance data (Lipid Profile) will be collected during course of usual clinical practice or captured upon its availability.

Official Title
-----------------
To Explore the Treatment Effect of Various Commercially Available Statins on Patients With Hyperlipidemia

Conditions
-----------------
Hyperlipidemias

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients diagnosed with hyperlipidemia Patients who are just starting a statin treatment, who need to switch from current therapy to a statin medication, or who are receiving dosage adjustment of statin as judged by the physicians Patients who are willing to participate in this study and who sign an informed consent form Exclusion Criteria: Pregnancy or breast feeding Patient are illiterate or unable to fill the questionnaire for any reason Patients with contraindications to the use of certain statins as needed prescribed by physicians (as per commercially available statins package insert) including the use of rosuvastatin. Any clinical condition which, in the opinion of the attending physician, would not allow safe administration of the study medications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| 1<br>patients with hyperlipidemia newly initiating a statin; or switched from current therapy to a statin, or require dosage adjustment for statin | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on LDL-C, HDL-C, TG, TC |  | 3 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| ratio for treatment-to-goal |  | 3 6 months | 
| drug compliance |  | 3 6 months | 
| correlation between patient's insight and therapeutic outcome |  | 3 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Statin, LDL-C