linjc16/ctgov huggingface dataset:
The Effects of Serratus Anterior Plane Block on Postoperative Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative pain still remains a challenging problem in patients undergoing video-assisted thoracoscopic surgery (VATS). However, there is no gold standard for regional analgesia for VATS. Serratus anterior plane block (SPB) under ultrasound guidance has been described recently to achieve complete paresthesia of the hemithorax. Therefore, SPB has the possibility to provide analgesia following thoracic surgery. Pain following surgery is a critical side effect of surgery, which increases the risk of complications and delays a recovery. Therefore, SPB may help not only reduce pain following VATS, but also increase the quality of recovery. This study aims to investigate the effectiveness of ultrasound-guided SPB on the quality of recovery and pain in patients undergoing VATS.

Conditions
-----------------
Postoperative Quality of Recovery and Analgesia After Video-assisted Thoracoscopic Surgery

Intervention / Treatment
-----------------
* Drug: Ropivacaine
* Drug: Normal Saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients (20-65 years of age) scheduled for elective video-assisted thoracoscopic surgery ASA class I and II Exclusion Criteria: Allergy to local anesthetics or contraindication to use of ropivacaine Pregnancy Neurologic and psychologic disease Severe cardiovascular disease Liver failure Renal failure Chronic treatment with analgesics

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ropivacaine group<br>45 patients will be randomly allocated into ropivacaine group with 0.4 ml/kg of 0.375% ropivacaine after induction of anesthesia. | Drug: Ropivacaine<br>* 90 patients are randomly allocated into two groups: ropivacaine group (n=45), saline group (n=40). In the ropivacaine group, ultrasound-guided serratus anterior plane block is performed with 0.4 ml/kg of 0.375% ropivacaine after induction of anesthesia. In the saline group, ultrasound-guided serratus anterior plane block is performed with 0.4 ml/kg saline after induction of anesthesia.<br>|
| Placebo Comparator: saline group<br>40 patients are randomly allocated into saline group with 0.4 ml/kg saline after induction of anesthesia. | Drug: Normal Saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of Recovery 40 score |  | 24 hours after operation day |
Evaluation of qSOFA in Neurosurgical Patients

Study Overview
=================
Brief Summary
-----------------
The aim of the study is to look if Quick Sequential Organ Failure Assessment Score score in detecting a eary Sepsis is afflicted by neurosurgical disorders

Official Title
-----------------
Prospective Evaluation of qSOFA (Quick Sequential Organ Failure Assessment Score) to Detect Systemic Infection in Neurosurgical Patients

Conditions
-----------------
Brain Injuries, Brain Trauma, Subarachnoid Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: one of the following diseases Subarachnoidal Bleeding Traumatic brain injury Spondylodiszitis Exclusion Criteria: intubated before income Age under 16
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 |
| --- | --- | --- |
| Baseline measurement of qSOFA at admission to ICU | assessment of qSOFA (Quick Sequential Organ Failure Assessment Score) | Measurement at the time of admission to the intensive care unit |
Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting

Study Overview
=================
Brief Summary
-----------------
To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the test results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry analyzer.

Detailed Description
-----------------
To establish the correlation between measurand values as obtained from the Samsung LABGEO PT10 Hepatic Panel at the point of care, and the corresponding measurand values as obtained on a commercial clinical chemistry analyzer, with respect to prospectively collected human serum specimens.

Official Title
-----------------
Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting

Conditions
-----------------
Hepatic Disease

Intervention / Treatment
-----------------
* Device: Samsung LABGEO PT10 Hepatic Panel


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female subjects with a history of elevated liver enzymes or symptoms suggestive of elevated liver enzymes Presenting to the site and requiring testing for levels of liver enzymes as part of routine care at the site Subjects able and willing to provide written informed consent Exclusion Criteria: Subjects unable or unwilling to provide written informed consent Subjects with a life-threatening disease or any serious, potentially life-threatening medical illness that may compromise patient safety or study conduct
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 |
| --- | --- |
| symptoms of liver disease<br>Device: Samsung LABGEO PT10 Hepatic Panel | Device: Samsung LABGEO PT10 Hepatic Panel<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay |  | baseline | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences. |  | baseline | 
| Standard deviation and coefficients of variation of between run, between day and total precision. |  | 20 days | 
| Estimates of reference intervals by computing the 2.5th percentile of associated distribution of test measurement (for each analyte) and the 97.5th percentile of associated distribution. |  | baseline | 
| Mean percentage difference between all pairs of serum and whole blood measurements using Bland-Altman plot of differences. |  | baseline | 
| Mean percentage difference between all pairs of plasma and whole blood measurements using Bland-Altman plot of differences. |  | baseline |
A Open Label Study in Previously Studied, SBC-103 Treatment Naïve MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously

Study Overview
=================
Brief Summary
-----------------
This study evaluated the safety and tolerability of intravenous (IV) administration of SBC-103 in previously studied, SBC-103 treatment naïve patients with mucopolysaccharidosis III, type B (MPS IIIB, Sanfilippo B) who participated in the NGLU-CL01 study. The NGLU-CL01 study was a non-interventional study that evaluated structural brain abnormalities and blood brain barrier (BBB) integrity by magnetic resonance imaging (MRI) and cerebrospinal fluid/serum albumin index.

Official Title
-----------------
A Phase I/II Open Label Study in Previously Studied, SBC-103 Treatment Naïve MPS IIIB Subjects to Investigate the Safety, Pharmacokinetics, and Pharmacodynamics/Efficacy of SBC-103 Administered Intravenously

Conditions
-----------------
Mucopolysaccharidosis III, Type B (MPS IIIB), Sanfilippo B

Intervention / Treatment
-----------------
* Drug: SBC-103


Participation Criteria
=================
Eligibility Criteria
-----------------
Participants from NGU-CL01 study were enrolled into the NGLU-CL01-T study. Subjects who met all of the inclusion criteria and none of the exclusion criteria were eligible to participate in this study.

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SBC-103<br>Patients were administered 1 mg/kg by IV infusion once every other week (qow) for at least 12 weeks. After evaluation of 12-week safety, tolerability, and pharmacodynamic data in individual patients, the dose was increased to 3 mg/kg qow. Infusions were to be at least 10 days apart and were administered every 14 days ±5 days. | Drug: SBC-103<br>* SBC-103 is a recombinant human alpha-N-acetylglucosaminidase (rhNAGLU). Patients were started with low dose of SBC-103 for 12 weeks and then will escalate to a higher dose.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of SBC-103 | The planned primary endpoint of this study was safety and tolerability of SBC-103 in patients with MPS IIIB, as measured by Number of participants with treatment-emergent adverse events, including serious adverse events; infusion-associated reactions; incidence of antidrug antibodies, clinical laboratory tests, cerebrospinal fluid findings, vital signs, and prior and concomitant medications | Planned duration was baseline to 164 weeks but due to early termination of the study, actual is 96 weeks. |
Myo-inositol Versus Metformin in Obese Women With Polycystic Ovary Syndrome

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to compare the effects of six months treatment of two insulin-lowering therapies on the clinical and endocrine-metabolic parameters in obese women affected by polycystic ovary syndrome. The study group includes 40 patients, randomly allocated to subgroup A (metformin 1500 mg/day) and subgroup B (myo-inositol 1500 mg/day). The investigations include menstrual pattern and hirsutism score evaluation, hormonal assays, oral glucose tolerance test, euglycemic hyperinsulinaemic clamp and lipid profile at baseline and after six months of treatment.

Official Title
-----------------
Myo-inositol Versus Metformin: Effects of Six Months Treatment on Clinical, Endocrine and Metabolic Features in Obese Women With Polycystic Ovary Syndrome

Conditions
-----------------
Polycystic Ovary Syndrome

Intervention / Treatment
-----------------
* Drug: metformin 1500 mg
* Drug: myoinositol 1500 mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: women with Polycystic Ovary Syndrome, diagnosed in accordance with Rotterdam Consensus Conference Criteria 2003; BMI>25 kg/m2; age 18-35 years. Exclusion Criteria: pregnancy; significant liver or renal impairment; other hormonal dysfunction (hypothalamic, pituitary, thyroidal or adrenal causes for the clinical signs); neoplasms; unstable mental illness; diagnosis of diabetes mellitus or impaired glucose tolerance; use of drugs able to interfere with gluco-insulinaemic metabolism for at least three months prior to entering the study.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
-----------------
Female

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: myo-inositol<br>1500 mg/day myoinositol | Drug: myoinositol 1500 mg<br> <br> |
| Active Comparator: metformin<br>1500 mg/day of metformin | Drug: metformin 1500 mg<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of cycles |  | six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| effects of two therapies on glyco-insulinemic metabolism | Area under the curve insulin post oral glucose tolerance test (μUI/ML/180min), M value of euglycemic hyperinsulinaemic clamp(mg/kg/min). | six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Polycystic ovary syndrome, myoinositol, metformin, glucose-insulinemic metabolism, menstrual pattern, insulin-lowering therapies
Oxidative Stress and Cardiac Arrest

Study Overview
=================
Brief Summary
-----------------
Cardiac arrest is a major health problem reaching 375000 cases in Europe each year. Only 5 to 31 % survive after an out of hospital cardiac arrest (OHCA). The main complication after OHCA is the anoxic encephalopathy. Recently mild hypothermia has shown a beneficial effect on survival. But the mechanisms underlying these therapy are not clear. Cardiac arrest is an example of ischemia reperfusion of the entire body. And it is well demonstrated that reperfusion generates an oxidative stress. But it has never been shown in a clinical setting. The aim of the study is to evaluate oxidative stress after out of hospital cardiac arrest treated with mild hypothermia.

Official Title
-----------------
Evaluation of Oxidative Stress After Out of Hospital Cardiac Arrest Treated With Moderate Hypothermia

Conditions
-----------------
Heart Arrest

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Out of hospital cardiac arrest Exclusion Criteria: refractory shock moribund patient resuscitation > 60 minutes hypothermia < 30 degrees

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Out of hospital cardiac arrest<br>Out of hospital cardiac patients successfully resuscitated and admitted to ICU | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Oxidative stress markers and antioxidants after out of hospital cardiac arrest |  | 4 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lactate after out of hospital cardiac arrest |  | 4 days | 
| Outcome after out of hospital cardiac arrest |  | 6 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
heart arrest, oxidative stress, lactic acid, outcome
The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

Study Overview
=================
Brief Summary
-----------------
If you are allergic to ragweed, and not taking certain medications, you will be asked to have blood drawn. We will perform experiments on your blood cells.

Detailed Description
-----------------
Adult ragweed allergic subjects will have blood drawn. Basophils will be enriched and stimulated with allergen and controls. Supernatants from these stimulations will be assayed for cytokines and histamine.

Official Title
-----------------
The Effect of Xolair on Inhibiting Leukotriene and Cytokine (IL-4 and IL-13) Release From Blood Basophils

Conditions
-----------------
Allergy

Intervention / Treatment
-----------------
* Drug: Placebo
* Drug: Xolair


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Ages 19 to 50 At least 2 year history of ragweed allergic rhinitis Positive skin prick tests to ragweed >5 mm wheal diameter IgE <700 iU/m Exclusion Criteria: Use of prohibited medications (e.g. antihistamine in past 7 days and topical or oral corticosteroids in past 1 month, beta-agonist or theophylline for 2 days. History of immunotherapy in the past 2 years Exposure to Omalizumab in the past 2 years Clinically significant non-allergic or perennial rhinitis to avoid mediator release due to environmental allergens Asthma other than mild intermittent Women of childbearing potential who are not on an accepted form of birth control, as well as women who are breastfeeding Known sensitivity to study drug Xolair Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study Patients with a previous history of cancer Use of any other investigational agent in the last 30 days

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 50 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: 1<br>Saline injection to match active | Drug: Placebo<br>* Placebo, Q2 or 4 weeks depending on Ige level and weight as appropriate for active treatment.<br>* Other names: Saline;|
| Experimental: Treatment<br>Active treatment with Xolair 150 to 375 mg is administered SC every 2 or 4 weeks | Drug: Xolair<br>* 150 to 375 mg is administered SC every 2 or 4 weeks<br>* Other names: Omalizumab, rhumab-E25;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Basophil histamine release |  | After 4 weeks treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
IL13, Cytokines, Basophil stimulation
GeneMatch: A Program of the Alzheimer's Prevention Registry to Match Individuals to Studies Based on Apolipoprotein E (APOE) Genotype

Study Overview
=================
Brief Summary
-----------------
The purpose of the Alzheimer's Prevention Registry GeneMatch program is to identify a large group of people interested in participating in research studies or clinical trials based in part on their genetic background. This genetic information will be used to match interested individuals to studies, providing a recruitment resource to the Alzheimer's scientific community. Interested individuals should visit www.endALZnow.org/GeneMatch to join the GeneMatch program.

Detailed Description
-----------------
The primary objectives of the Alzheimer's Prevention Registry GeneMatch program are to (1) identify and characterize a large cohort of people who are interested in, and may be eligible to participate in, current and future preclinical Alzheimer's disease research studies and clinical trials based on their genetic background, and (2) provide information to these individuals about research studies for which they may be eligible, based in part on their genetic background. Cognitively unimpaired individuals age 50 to 90, inclusive, are eligible to enroll in GeneMatch. GeneMatch will provide participants with a genetic sample kit (a cheek swab) to test for a specific gene called apolipoproteins E (APOE). GeneMatch does not disclose the results of the APOE test to participants. GeneMatch may use the APOE test results to match participants to research studies. Participants are under no obligation to pursue these study opportunities.

Official Title
-----------------
Alzheimer's Prevention Registry GeneMatch Program

Conditions
-----------------
Alzheimer Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 50-90, inclusive Provide basic demographic, medical history, and contact information Consent to APOE genotyping without receiving results Live in the United States Exclusion Criteria: Unable to comply with this project's protocol requirements Self-reported diagnosis of dementia or any other objective cognitive impairment syndrome

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 90 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 individuals who enroll in GeneMatch |  | 15 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of individuals referred to research studies |  | 15 years | 
| Number of individuals who enroll in research studies |  | 15 years |