linjc16/ctgov huggingface dataset:
Validation of Progranulin as a Biomarker for Sepsis

Study Overview
=================
Brief Summary
-----------------
Progranulin blood concentrations in patients with sepsis will be analysed in relation to disease status in order to validate progranulin as a biomarker for sepsis. Patients undergoing cardiac surgery will serve as controls.

Detailed Description
-----------------
Single nucleotide polymorphisms with known effects on Progranulin plasma concentrations will be assessed in a separate analysis. Expression levels of microRNAs isolated from plasma, circulating exosomes and blood cells will be determined by next-generation sequencing to characterize epigenetic influences on progranulin plasma levels.

Official Title
-----------------
Sensitivity and Specificity of Progranulin as a Biomarker for Sepsis

Conditions
-----------------
Sepsis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Sepsis or Septic Shock defined according to SEPSIS-3 criteria - Age > 18 years Exclusion Criteria: No informed consent Age < 18 years Pregnancy Immunosuppression (including transplantation) Charlson Comorbidity Index > 0 (healthy volunteers)

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 |
| --- | --- |
| Sepsis<br>Patients with sepsis | |
| Cardiac Surgery<br>Patients undergoing cardiac surgery | |
| Healthy controls<br>Normal individuals | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in progranulin plasma concentrations during ICU - therapy | Blood samples will be taken at the abovementioned time points | ICU admission, day 1, day 4 of ICU therapy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in miRNA expression levels in exosomes, serum and blood cells during ICU - therapy | Blood samples will be taken at the abovementioned time points | ICU admission, day 1, day 4 of ICU therapy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Postoperative, Dysfunction Following Cardiac Surgery
Sphenopalatine Ganglion Block for Nasal Surery

Study Overview
=================
Brief Summary
-----------------
nasal surgery carries many perioperative challenges, intraoperative bleeing and its effect on surgical field i the main intraoperative concern an postoperative agitation and its serious complications is the main postoperative challenge.

Official Title
-----------------
Efficacy of Intranasal Approach of Sphenopalatine Ganglion Block for Nasal Surery

Conditions
-----------------
Intraoperative Bleeding, Postoperative Delirium

Intervention / Treatment
-----------------
* Drug: Bupivacaine 0.5% Preservative-Free Injectable Solution
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patient written consent elective surgery age 18 - 40 year old Exclusion Criteria: patient refusal emergency surgery

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 40 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bupivacaine group<br> | Drug: Bupivacaine 0.5% Preservative-Free Injectable Solution<br>* 1.5 ml of Bupivacaine 0.5% Preservative-Free Injectable Solution used transnasally to block the sphenopalatine ganglion<br>|
| Placebo Comparator: saline group<br> | Drug: normal saline<br>* 1.5 ml of normal saline is delivered transnasally to the sphenopalatine ganglion<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative emergence agitation | i | 2 hour | 
| intraoperative bleeding |  | 2 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| postoperative opioid consumption |  | 2 hour |
Multicenter Study of the Safety and Efficacy of Dermal Filler, Belotero® Soft

Study Overview
=================
Brief Summary
-----------------
This study is to determine the safety and effectiveness of Belotero® Soft compared to active comparator in the correction of mild facial wrinkles, such as nasolabial folds.

Detailed Description
-----------------
The purpose of the study is to see if Belotero® Soft is safe and effective for correction of mild facial wrinkles, such as nasolabial folds. The second objective of the study is to see if Belotero® Soft works better than the active comparator. Subjects will receive Belotero® Soft injection to one side of the face and the active comparator to the other side of the face.

Official Title
-----------------
A Randomized,Blinded,Controlled,Multicenter Study of the Safety and Effectiveness of Dermal Filler, Belotero® Soft, After Superficial to Mid Dermal Implantation for Correction of Mild Facial Wrinkles Over 4 Weeks.

Conditions
-----------------
Facial Wrinkles

Intervention / Treatment
-----------------
* Device: CosmoDerm1
* Device: Belotero Soft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects must have bilateral facial wrinkles, such as nasolabial folds Exclusion Criteria: Other nasolabial fold correction within 6 months prior to study entry.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 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: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Belotero® Soft<br>Comparator will be given into the opposite side of the face that Belotero® Soft was administered for facial wrinkles, such as nasolabial folds. | Device: Belotero Soft<br>* Dermal Filler<br>|
| Active Comparator: CosmoDerm1<br> | Device: CosmoDerm1<br>* CosmoDerm1 is a single use syringe, injected into the mid dermal layer.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The severity of the facial wrinkle |  | 2 weeks and 4 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator and subject assessments |  | 2 weeks and 4 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Facial wrinkles, Nasolabial folds
Molecular and Cellular Characterization of Skull Base Tumors

Study Overview
=================
Brief Summary
-----------------
The purpose of the study is to analyze biological samples and genetic material for basic science research investigating the molecular and cellular characterization of skull base tumors.

Detailed Description
-----------------
The overall goal of this proposal is to determine new molecular and cellular features that define tumor subtypes that are clinically actionable, may drive important changes in patient management, and/or elucidate novel chemotherapeutic options. Skull base tumors are currently diagnosed based on histopathologic criteria, on which post-operative management is based. However, the investigators hypothesize that each tumor type (eg. chordoma or chondrosarcoma) will have molecular and/or cellular subcategories that will redefine how to categorize and diagnose patients, predict clinical outcome, and optimally design a patient-specific management strategy. In addition, we aim to catalogue changes that occur after treatment after surgical resection, chemotherapy, and/or radiation by comparing primary and recurrent tumors.

Official Title
-----------------
Molecular and Cellular Characterization of Skull Base Tumors

Conditions
-----------------
Skull Base Neoplasm, Cellular Pathology

Intervention / Treatment
-----------------
* Other: Observation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of a skull base tumor Exclusion Criteria: Insufficient tumor sample at time of resection
Sexes Eligible for Study
-----------------
All

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: Observation|Understanding the biology of skull base tumors will teach the investigators about the genesis and/or mechanisms of treatment resistance. The investigators hope to ultimately identify new targets which will add to the armamentarium by which to treat these tumors.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient overall survival will be measured and reported. | There will be one outcome measure: overall survival. | Through study completion, an average of 10 years |
Expanded Access to ABT-414

Study Overview
=================
Brief Summary
-----------------
This is an expanded access program (EAP) for eligible participants. This program is designed to provide access to ABT-414 prior to approval by the local regulatory agency. Availability will depend on territory eligibility. Participating sites will be added as they apply for and are approved for the EAP. A medical doctor must decide whether the potential benefit outweighs the risk of receiving an investigational therapy based on the individual patient's medical history and program eligibility criteria.

Official Title
-----------------
Expanded Access to ABT-414

Conditions
-----------------
Glioblastoma or Solid Tumors, Epidermal Growth Factor Receptor (EGFR) Diagnosis

Intervention / Treatment
-----------------
* Drug: ABT-414


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant must have epidermal growth factor receptor (EGFR) amplification or EGFRvIII mutation. Health Care Provider (HCP) must have prior clinical trial experience with ABT-414. The participant must not be eligible for an ABT-414 clinical trial. Pediatric participants may be evaluated on a case by case basis.

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 |
| --- |
|Drug: ABT-414|ABT-414 will be administered by intravenous infusion|

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
-----------------
Expanded Access, Pre-approval Access, Compassionate Use, Special Access Program, Named Patient Basis, Special Access Scheme
Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).

Study Overview
=================
Brief Summary
-----------------
This protocol describes procedures for the collection of blood samples for the intent of determining genetic contribution to the safety and efficacy of CPT/FU/LV.

Official Title
-----------------
Pharmacogenomics Blood Sampling Protocol For Irinotecan/Fluorouracil/Leucovorin(CPT-11/FU/LV).

Conditions
-----------------
Colorectal Neoplasms

Intervention / Treatment
-----------------
* Procedure: Blood draw


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participation in studies employing treatment with irinotecan and a signed informed consent. Exclusion Criteria: None.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Blood draw|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of genotype with safety and efficacy measures. |  |  |
A Combination of Two Currently Approved Drugs to Enhance the Treatment of Schizophrenia

Study Overview
=================
Brief Summary
-----------------
Study of a medication for the treatment of Schizophrenia in patients who are already taking Abilify, Risperdal, Seroquel, Zyprexa

Conditions
-----------------
Schizophrenia

Intervention / Treatment
-----------------
* Drug: olanzapine
* Drug: atomoxetine
* Drug: placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have a clinical diagnosis of Schizophrenia Must be at least 18 years of age and not older than 55 years of age Must have been stable on a dose of Abilify, Risperdal, Seroquel, or Zyprexa for the past 8 weeks Women of childbearing potential must be using a medically accepted means of contraception Must be able to swallow capsules Exclusion Criteria: Has serious health problems other than Schizophrenia Takes an antidepressant for depression Takes insulin for diabetes Have a history of alcohol or drug dependence (except for nicotine and caffeine) within the past 6 months

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: olanzapine|nan|
|Drug: atomoxetine|nan|
|Drug: placebo|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Effect of Monosaccharides on Intestinal Barrier Function

Study Overview
=================
Brief Summary
-----------------
The aim of the present study is to determine the effect of monosaccharides on intestinal barrier function in healthy subjects.

Detailed Description
-----------------
In the intervention study normal weight participants will receive defined amounts of monosaccharides for several days. Before and after intervention parameters of intestinal barrier function will be assessed.

Official Title
-----------------
Exploratory Study on the Modulation of Endotoxemia and Metabolic Parameters: Role of Macronutrients

Conditions
-----------------
Dietary Habits, Endotoxemia

Intervention / Treatment
-----------------
* Other: Dietary Intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: BMI <25 kg/m2 no kown history of metabolic disorders or fatty liver Exclusion Criteria: food allergies or intolerances (esp. fructose intolerance and malabsorption) renal insufficiency chronic disease of the gastrointestinal tract taking drugs affecting lipid or glucose metabolism

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 75 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: All participants receive all interventional diets.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Monosaccharide 1<br>Participants receive standardized meals with a defined amount of monosaccharide 1. | Other: Dietary Intervention<br>* Participants receive different monosaccharides for a defined number of days.<br>|
| Experimental: Monosaccharide 2<br>Participants receive standardized meals with a defined amount of monosaccharide 2. | Other: Dietary Intervention<br>* Participants receive different monosaccharides for a defined number of days.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in parameters of intestinal barrier function | Changes in endotoxin plasma levels | 1 week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes in blood pressure | Changes in systolic and diastolic blood pressure | 1 week | 
| Changes in markers for glucose metabolism | Changes in fasting glucose and fasting insulin levels | 1 week | 
| Changes in blood lipid levels | Changes in triglyceride levels | 1 week | 
| Changes in Uric Acid levels | Changes in Uric Acid blood levels | 1 week |
Sulfonylurea Response in Patients With Diabetes Due to Kir6.2 Mutations

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate whether patients with diabetes due to Kir6.2 mutations can be treated with sulfonylurea medication rather than insulin, and if this is the case to investigate the mechanism for sulfonylurea response.

Official Title
-----------------
A Prospective Study of Sulfonylureas in Patients With Diabetes Due to Kir6.2 Mutations

Conditions
-----------------
Diabetes Mellitus

Intervention / Treatment
-----------------
* Drug: Sulfonylurea


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diabetes due to KCNJ11 (Kir6.2) mutation Exclusion Criteria: None
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: Sulfonylurea|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c reduction |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin secretory response to intravenous glucose |  |  | 
| insulin secretory response to oral glucose |  |  | 
| insulin secretory response to mixed meal (sustacal) |  |  | 
| Incidence of Hypoglycemia |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Sulfonylurea, Permanent Neonatal Diabetes, Kir6.2, KCNJ11, Infancy onset diabetes
Safety on Switching Between Different Botulinum Toxin-A

Study Overview
=================
Brief Summary
-----------------
Clinical guidelines recommend the use of Botulinum Toxin-A (BoNT-A) for localized/segmental spasticity in children with cerebral palsy. At the Kocaeli University (KOU) Department of Physical Medicine and Rehabilitation (PMR) more than 800 patients have been injected with the two approved toxinA types; OnabotulinumtoxinA or AbobotulinumtoxinA. With this study investigators would like to evaluate retrospectively if switching from one toxin to another is safe as well as to evaluate if the efficacy when switching from one toxin to another was maintained.

Detailed Description
-----------------
A data base was designed to capture all data that were considered relevant to the treatment evaluation. The data were transcribed directly from participants medical records. For the purpose of the study, data from the two subsequent visits where a different type of toxin was given will be collected and evaluated . In order to collect the pre and post status in terms of safety and efficacy, for each participant, data corresponding to the 6 previous and posterior months after the switch of the toxin will also be collected or data corresponding to the previous and posterior visit after the switch of the toxin will also be collected.

Official Title
-----------------
Switching Between Different Types of Botulinum Toxin-A in Children With Cerebral Palsy Treated for Spasticity: a Safety Retrospective Evaluation

Conditions
-----------------
Cerebral Palsy

Intervention / Treatment
-----------------
* Drug: Botulinum toxin type A


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children diagnosis of cerebral palsy with respect to Rosenbaum criteria, children having received repeated injections with two different types of toxinA treatment into their lower limb(s) Exclusion Criteria: children without repeated Botulinum toxin type A injections children having received repeated injections with same type of toxinA

Ages Eligible for Study
-----------------
Minimum Age: 2 Years
Maximum Age: 18 Years

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Botulinum toxin type A|Botulinum toxin type A|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurence of treatment related adverse events | Overall and per injection cycle | Up to 30 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modified Ashworth Scale | Spasticity Assessment Scale | Up to 30 months | 
| Tardieu Scale | Spasticity Assessment Scale | Up to 30 months | 
| Observational Gait Scale | Gait Assessment Scale | Up to 30 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Botulinum Toxin-A