linjc16/ctgov huggingface dataset:
Comparison of Palonosetron and Ramosetron for Preventing Patient-controlled Analgesia Related Nausea and Vomiting Following Spine Surgery; Association With ABCB1 Polymorphism

Study Overview
=================
Brief Summary
-----------------
Opioid-based intravenous patient-controlled analgesia (IV-PCA) offers excellent pain control, however, its use inevitably increases the incidence of postoperative nausea and vomiting (PONV). Ramosetron and palonosetron are commonly used 5-HT3 antagonists for the prevention and treatment of PONV. It is not clear which one has superior antiemetic efficacy for the prevention of PONV in patients using opioid-based IV-PCA. The antiemetic efficacy of 5HT3 antagonists may be influenced by polymorphism of ABCB1, a drug-transporter gene. This study evaluates relative antiemetic efficacy of ramosetron and palonosetron in patients using IV-PCA after spinal surgery and impact of ABCB1 polymorphism on the antiemetic efficacy of the ramosetron and palonosetron. The incidence and intensity of PONV during postoperative 48 h will be assessed. ABCB1 polymorphisms 3435C>T and 2677G>T/A will be evaluated in all patients.

Conditions
-----------------
Postoperative Nausea and Vomiting

Intervention / Treatment
-----------------
* Drug: Ramosetron
* Drug: Palonosetron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged 20-85 yr undergoing spine surgery Exclusion Criteria: Taking steroids or opioids preoperatively GI motility disorder Uncontrolled diabetes Severe renal or hepatic disease Transfer to ICU postoperatively Obesity (BMI>35 kg/m2) Use of antiemetic agent within 24 h preoperatively Pregnancy Psychiatric disease Drug or alcohol abuser Malignancy

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 85 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ramosetron<br>patients receiving ramosetron for prophylaxis of postoperative nausea and vomiting | Drug: Ramosetron<br>* ramosetron 0.3 mg IV 20 min before the end of surgery and 24 h after the surgery<br>|
| Active Comparator: palonosetron<br>patients receiving palonosetron for prophylaxis of postoperative nausea and vomiting | Drug: Palonosetron<br>* palonosetron 0.075 mg IV 20 min before the end of surgery and 24 h after the surgery.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| number of postoperative nausea and vomiting incidence |  | during postoperative 48h |
Effect of Garlic on Inflammatory Mediators

Study Overview
=================
Brief Summary
-----------------
This research will investigate the effect of garlic oil extract when added to daily diet on inflammatory mediators and blood clotting activation.

Detailed Description
-----------------
To investigate the pharmacokinetics of one of the garlic oil macerate, Ajoene, the anti-inflammatory effect of garlic oil macerate on the pro-inflammatory transcription factor NF-kB, it's activating proteins, including IkB, IkB Kinases a and B (IKKa and IKKB) and the pro-inflammatory NF-kB-regulated proteins, c-reactive protein (CRP), tumor necrosis factor-alpha (TNF-a), soluble intercellular adhesion molecule-1 (sICAM-1), soluble vascular cell adhesion molecule-1 (sVCAM-1), matrix metalloproteinase-9 (MMP-9), plasminogen activated protein-1 (PAI-1)and the effect of garlic oil macerate intake on platelet activation in normal subjects.

Official Title
-----------------
Effect of Garlic Oil Macerate on Inflammatory Mediators in Healthy Normal Weight and Obese Subjects.

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: Garlic Oil Macerate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age and older Normal subjects with BMI <25, obese subjects with BMI >30 Subjects who have consented to adhere to the diet, regular weekly visits, and blood draws. Exclusion Criteria: Subjects on any antioxidant medication. Patient on non-steroidal anti-inflammatory drug. On any agent with antioxidant properties. History of drug or alcohol abuse. Any life threatening disease. On any agent with significant antioxidant properties. Taking garlic extracts in the diet regularly.

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Garlic Oil Macerate|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 1. To examine the pharmacokinetics of the garlic oil macerate. |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 2. To examine the effect of garlic oil macerate on inflammatory mechanisms at the cellular and molecular level. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Effects of Garlic
China Betaferon Adherence, Coping and Nurse Support Study

Study Overview
=================
Brief Summary
-----------------
Non-adherence reduces treatment benefit and can bias the assessment of treatment efficacy thereby involving safety risks for the patient and influencing health cost-effectiveness. This observational study will concentrate upon the role of MS nurses in influencing adherence. This study will examine the influence of initial and subsequent periodic nurse interviews which aim to improve adherence to Betaferon® treatment.

Official Title
-----------------
Prospective Study of Betaferon in Adherence, Coping and Nurse Support in Patients of Chinese Origin With Multiple Sclerosis

Conditions
-----------------
Multiple Sclerosis, Chronic Progressive

Intervention / Treatment
-----------------
* Drug: Interferon beta-1b (Betaseron, BAY86-5046)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Relapsing-remitting multiple scelrosis (RRMS) and secondary progressive multiple sclerosis (SPMS) patients Having Betaferon treatment, including patients who are First time using; or Re-staring; or Switching from other diseases modifying drugs (DMDs) Exclusion Criteria: Known or newly identified contraindication for administration of Betaferon according to Summary of Product Characteristic (SmPC).

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1<br> | Drug: Interferon beta-1b (Betaseron, BAY86-5046)<br>* All patients will be prescribed with Betaseron and be instructed on treatment by their phisicians<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to Betaferon treatment: proportion of patients adhering to Betaferon treatment |  | at 6, 12, 18 and 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ways of Coping Questionnaire (WCQ) |  | at 6, 12, 18 and 24 months | 
| Hospital Anxiety and Depression Scale (HAD) |  | at 6, 12, 18 and 24 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Relapsing-Remitting Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Midline Failures: A Comparison Between a Hydrophilic Biomaterial and Thermoplastic Polyurethane

Study Overview
=================
Brief Summary
-----------------
Retrospective chart review to evaluate and compare the rate of failures between midlines made from different materials

Official Title
-----------------
Midline Failures: A Comparative, Retrospective Chart Review

Conditions
-----------------
Midline Catheter

Intervention / Treatment
-----------------
* Device: HydroMID
* Device: TPU


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects who have been inserted with the HydroMID by the vascular access group Subjects who have been inserted with a competitor 4 Fr single lumen by the vascular access team Exclusion Criteria: Any off-label use (PICC lines cut to be midlines for any manufacturer)
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| TPU<br>Thermoplastic polyurethane | Device: TPU<br>* Thermoplastic polyurethane<br>|
| HBM<br>Hydrophilic BioMaterial | Device: HydroMID<br>* Hydrophilic biomaterial<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this chart review is to evaluate the rates of failure of midlines made from different materials. |  | retrospective review- March 2021 through May 2021 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the proportion of times the midline was used to successfully complete prescribed length. |  | retrospective review- March 2021 through May 2021 |
PCSK9 Inhibitor Treatment for Patients With SPG5

Study Overview
=================
Brief Summary
-----------------
Spastic paraplegia type 5 (SPG5) is a rare subtype of hereditary spastic paraplegia, a highly heterogeneous group of neurodegenerative disorders defined by progressive neurodegeneration of the corticospinal tract motor neurons. SPG5 is caused by recessive mutations in the gene CYP7B1 encoding oxysterol-7a-hydroxylase. This enzyme is involved in the degradation of cholesterol into primary bile acids. CYP7B1 deficiency has been shown to lead to accumulation of neurotoxic oxysterols. Oxysterols were found to impair metabolic activity and viability of human cortical neurons at concentrations found in SPG5 patients, indicating that elevated levels of oxysterols might be key pathogenic factors in SPG5. Monoclonal antibodies that inhibit proprotein convertase subtilisin-kexin type 9 (PCSK9) have emerged as a new class of drugs that effectively lower cholesterol levels. Evolocumab, a member of this class, is a fully human monoclonal antibody that reduces LDL cholesterol levels by approximately 60%. We thus performed this interventional trial with Evolocumab 420 mg for SPG5 patients.

Official Title
-----------------
PCSK9 Inhibitor Treatment for Patients With Hereditary Spastic Paraplegia Type 5

Conditions
-----------------
Hereditary Spastic Paraplegia Type 5

Intervention / Treatment
-----------------
* Drug: evolocumab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 14-80 years Probands with clinically manifest hereditary spastic paraplegia Genetically confirmed diagnosis of SPG5 Exclusion Criteria: Comprised treatment with statins 3 months prior to enrolment Contraindications to PCSK9 inhibitor therapy Pregnancy was excluded in women of childbearing age

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 80 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Evolocumab group<br>Eligible patients receive subcutaneous injections of evolocumab 420 mg | Drug: evolocumab<br>* Eligible patients receive subcutaneous injections of evolocumab 420 mg<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change of 27-hydroxycholesterol (27-OHC) | Cholesterol is initially side chain oxidized and the resulting 27-hydroxycholesterol (27-OHC) are 7a-hydroxylated | up to 4 weeks |
Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether ultrasound study of the airway to predict endotracheal tube size in anesthetized pediatric patients better than the tube size formula

Detailed Description
-----------------
This study is to compare the methods of selecting uncuffed endotracheal tube size in pediatric patients between conventional age-based formula and ultrasound measurement of subglottic diameter.

Official Title
-----------------
Ultrasound Study of the Airway to Predict Endotracheal Tube Size in Anesthetized Pediatric Patients

Conditions
-----------------
Pediatric General Anesthesia With Endotracheal Tube

Intervention / Treatment
-----------------
* Diagnostic Test: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1-6 Years ASA class 1-2 Elective Surgery GA with oral uncuff endotracheal tube Exclusion Criteria: Potential difficult air way from history and physical exam Allergy ti ultrasound gel neck mass unstable vital sign

Ages Eligible for Study
-----------------
Minimum Age: 1 Year
Maximum Age: 6 Years

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: randomized controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br>Using ultrasound measurement of the subglottic area to choose endotracheal tube size | Diagnostic Test: Ultrasound<br>* Using ultrasound to determine the size of endotracheal tube<br>|
| No Intervention: Formula<br>Using Cole's formula to choose endotracheal tube size | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proper size of endotracheal tube | Clinically fit of endotracheal tube with leak at 20-25 cmH2O | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation of subglottic diameter and proper size endotracheal tube | Correlation of subglottic diameter measured by ultrasound and proper size endotracheal tube determined by clinically fit. | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ASA class 1,2, age 1-6 years, General anesthesia with ETT
Recombinant Human Thrombopoietin for Mobilization of Peripheral Blood Progenitor Cells for Autologous Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether recombinant human thrombopoietin are effective in peripheral blood progenitor cells mobilization for autologous transplantation.

Conditions
-----------------
Thrombocytopoietin, Hematopoietic Stem Cell Mobilization, Hematopoietic Stem Cell Transplantation

Intervention / Treatment
-----------------
* Drug: Recombinant Human Thrombopoietin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: a histologically confirmed diagnosis of Hodgkin's disease, non-Hodgkin's lymphoma, or selected high-risk solid tumors that are planned to receive autologous peripheral blood progenitor cell transplantation Eastern Cooperative Oncology Group performance status of 0 - 2. Exclusion Criteria: abnormal liver function (aminotransferase or bilirubin levels 2 times upper limit of normal), leukopenia (white blood cell count 3000/L), or a history of platelet or other disorders associated with a bleeding diathesis a history of thromboembolic disease, coronary heart disease,stroke, arrhythmias, central nervous system metastases,or other organ system diseases or abnormalities that might predispose individuals to treatment-related complications

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| Experimental: TPOqd<br>Recombinant Human Thrombopoietin 300U/kg/d ih quaque die, day-3/-2/-1 before mobilization | Drug: Recombinant Human Thrombopoietin<br>* Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.<br>|
| Active Comparator: TPOqod<br>Recombinant Human Thrombopoietin 300U/kg/d ih qua altera die, day-3/-1/+2 before mobilization | Drug: Recombinant Human Thrombopoietin<br>* Recombinant human Thrombopoietin is a full length glycosylated molecule identical to endogenous Thrombopoietin.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| the average number of cluster of differentiation 34 positive cells/kg | To evaluate the effect of combining various treatment schedules of recombinant human thrombopoietin with granulocyte colony stimulating factor on the mobilization of peripheral blood progenitor cells. | up to 24 months |
Seasonal Allergic Rhinitis and Driving Ability

Study Overview
=================
Brief Summary
-----------------
On-the-road driving performance of untreated seasonal allergic rhinitis patients during the allergic season (exposed) is compared to driving performance outside the allergic season (in winter, not-exposed).

Detailed Description
-----------------
This study was set-up to examine whether untreated seasonal allergic rhinitis has an effect on driving ability. In addition to the driving tests, patients perform a memory test in the laboratory.

Official Title
-----------------
Study to Investigate the Effects of Seasonal Allergic Rhinitis on Over-the-Road Driving Performance and Memory Functioning

Conditions
-----------------
Seasonal Allergic Rhinitis

Intervention / Treatment
-----------------
* Other: 1 week of treatment discontinuation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: outpatients with seasonal allergic rhinitis a valid driver's licence written informed consent a T5SS score >8 during the allergic season and <3 in winter Exclusion Criteria: use of medication or medical conditions that are known to affect driving ability associated ENT disease or asthma

Ages Eligible for Study
-----------------
Minimum Age: 21 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: Prevention
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: A<br>1 week of treatment discontinuation | Other: 1 week of treatment discontinuation<br>* 1 week of treatment discontinuation during allergic rhinitis season<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Driving test: Standard Deviation of Lateral Position (SDLP, cm); i.e. the weaving of the car [after 1 week of treatment discontinuation] |  | allergic season and winter | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Other driving test parameters: standard deviation of speed, mean speed, meal lateral position [after 1 week of treatment discontinuation] |  | allergic season and winter | 
| Memory test: immediate and delayed recall, delayed recognition [after 1 week of treatment discontinuation] |  | allergic season and winter | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
driving, memory
Optimal Flow Rate During Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Regardless of the development of cardiac surgery techniques and technologies, the question of an optimal extracorporeal circulation is still unanswered. There are globally accepted standards of perfusion, however, keep many of these procedures was not evidence-based review. Generally accepted are flow rates during cardiopulmonary bypasses of 2.5 L/min/m2. This target was derived from the physiological conditions, but they are not the result of an adapted adjustment to the fundamentally non-physiological processes during extracorporeal circulation. Among other things, an increased metabolic demand during re-perfusion is not taken into account. An increasing and optimizing of the standard flow rate of 0.5 L/min/m2 should be the aim of this investigation. Under optimal perfusion, the investigators are maintaining the microcirculation and organ protection in receipt of endothelial function and oxygen transport.

Official Title
-----------------
Optimal Flow Rate During Cardiopulmonary Bypass

Conditions
-----------------
Tissue Perfusion

Intervention / Treatment
-----------------
* Procedure: Flow rate


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Extracorporeal circulation Age > 18 Written consent Exclusion Criteria: Emergency cases

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Flow rate<br>Comparison between a flow rate of 2.5/l/min/m2 versus 3.0/l/min/m2 | Procedure: Flow rate<br>* Different flow rate during cardiopulmonary bypass<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Microcirulation | measurement with O2C | intraooperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiopulmonary bypass flow rate outcome tissue perfusion oxygenation l/min/m2