linjc16/ctgov huggingface dataset:
Does the Harmonic Scalpel Reduce Blood Loss and OR Time in Major Head and Neck Cancer Surgery Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma?

Study Overview
=================
Brief Summary
-----------------
The harmonic scalpel is a tool that may reduce operative blood loss. Some studies also indicate it may result in faster surgery. A recently published randomized study from our group shows the harmonic scalpel reduces blood loss in neck dissection but it did not offer any reduction in OR time. The present study investigates the utility of the harmonic scalpel in resections involving removal of oral cavity tissues as well as the neck. Oral cavity resections are especially prone to blood loss and we believe the harmonic scalpel will confer benefits in this type of surgery, potentially reducing the need for blood transfusion.

Official Title
-----------------
Does the Harmonic Scalpel Reduce Operating Time and Blood Loss in Patients Undergoing Major Surgery for Oral Cavity Squamous Cell Carcinoma? A Prospective, Randomized Trial.

Conditions
-----------------
Oral Cavity Squamous Cell Carcinoma, Treated With Surgery

Intervention / Treatment
-----------------
* Procedure: surgical resection


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age > 18 years oral cavity scc primary surgery including either uni or bilateral neck dissection (levels I-IV) Exclusion Criteria: previous treatment for head and neck cancer unable or unwilling to give informed consent history of bleeding disorder other contraindications to surgery

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: harmonic scalpel<br> | Procedure: surgical resection<br>* neck dissection and tumour resection will be performed either with or without the harmonic scalpel as an adjunct.<br>* Other names: Harmonic Focus handpiece;|
| Active Comparator: standard technique<br> | Procedure: surgical resection<br>* neck dissection and tumour resection will be performed either with or without the harmonic scalpel as an adjunct.<br>* Other names: Harmonic Focus handpiece;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| blood loss |  | intraoperative | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| operating time |  | intraoperative | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
oral cavity squamous cell carcinoma, head and neck cancer, oral cancer
3D Phase Sensitive Inversion Recuperation MRI to Detect and Characterize Multiple Sclerosis Spinal Cord Lesions

Study Overview
=================
Brief Summary
-----------------
This study aims to assess the interest of 3D Phase Sensitive Inversion Recuperation (PSIR)sequence in the MRI detection of spinal cord lesion. It will compare the sensitivity of this MRI sequence compared to the T1 and T2 sequences recommended in the assessment of neuraxis inflammatory diseases.

Conditions
-----------------
Multiple Sclerosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: age ≥ 18 years old patients scheduled for spinal cord MRI exploration for the assessment of neuraxis inflammatory diseases Exclusion Criteria: contraindication to MRI allergy to contrast media patient under legal protection no health insurance coverage patient's refusal to participate in the study

Ages Eligible for Study
-----------------
Minimum Age: 18 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 |
| --- | --- | --- |
| number of spinal cord lesions |  | baseline |
Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases.

Study Overview
=================
Brief Summary
-----------------
Retrospective analysis of a prospectively collected database of 170 patients between 2004 and 2020, who underwent liver resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital trying to determine rates and patterns of recurrence following liver resections for CRLM and concurrently, characterise clinical, pathological and treatment-related factors that could function as predictors of recurrence or survival, particularly neoadjuvant chemotherapy and tumour clearance.

Detailed Description
-----------------
This is a descriptive, observational study with retrospective analysis of a prospectively collated database. This database included all patients who underwent curative hepatic resections for CRLM (colorectal liver metastases) at The Queen Elizabeth Hospital (Adelaide, Australia) between December 2004 and October 2020.

Official Title
-----------------
Effect of Chemotherapy and Tumor Clearance in Hepatic Resections for Colorectal Liver Metastases. A Single-centre Cohort Study

Conditions
-----------------
Colorectal Cancer Metastatic, Liver Metastases

Intervention / Treatment
-----------------
* Procedure: Hepatectomy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients who underwent a liver resection for CRLM at The Queen Elizabeth Hospital between December 2004 to September 2020 Exclusion Criteria: Patients whose procedures were abandoned due to unresectable tumour burden

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 |
| --- |
|Procedure: Hepatectomy|Neoadjuvant treatment|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Recurrence | Recurrence rate | From surgery to recurrence, up to 16 years | 
| Survival | up to16 years | From surgery to death or end of the study, up to 16 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resection margins | Resection margins of the liver resection | From surgery to death or end of the study, up to 16 years | 
| Neoadjuvant Chemotherapy | Neoadjuvant Chemotherapy (yes or not) | From surgery to death or end of the study, up to 16 years |
Measuring the Effects of Touch Relaxation Painful Patients in Oncologie Nursing

Study Overview
=================
Brief Summary
-----------------
Measure the impact of touch relaxation on pain communicative patients suffering from chronic pain of cancer origin inpatient Oncology. measure over three days the effects on pain anxiety welfare and consumption of analgesics

Conditions
-----------------
Cancer

Intervention / Treatment
-----------------
* Other: massage


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: hospitalized in the oncology department at least 3 days presenting the cancerous type of pain caused by their disease or treatment numerical scale pain score = 4/10 receiving weak and strong opioids platelet count> 100 can receive anxiolytic adult Patient of both sexes no other relaxation approaches Exclusion Criteria: against indication to touch: wound, bruises, circulatory disorders, diseases psychiatiques risk of hematoma numerical scale pain score < 4/10 understanding of the difficulties of the French language no receiving weak and strong opioids

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

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: massage<br> | Other: massage<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain | pain measurement by the scale numerical pain | 3 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| anxiety | measurement with the scale of COVI | 3 days | 
| consumption of analgesics | daily creel analgesics and anxiolytics | 3 days | 
| wellness | measure with the scale of edmonton | 3 days |
Effect of Prostacyclin on Haemostasis in Abdominal Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate the effect of continuous perioperative infusion of prostacyclin on haemostasis and endothelial functionality in patients undergoing major abdominal surgery.

Official Title
-----------------
The Effect of Prostacyclin on Haemostasis as Evaluated by Thrombelastography and Endothelial Markers in Patients Undergoing Major Abdominal Surgery. A Pilot Study

Conditions
-----------------
Surgery

Intervention / Treatment
-----------------
* Drug: Prostacycline
* Drug: Isotonic saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men and women above 18 years old Undergoing Whipple surgery or liver resection Able and willing to give informed consent Exclusion Criteria: Allergy towards the study medication In treatment with platelet ADP receptor inhibitors or heparin (not including thrombosis prophylaxis), Factor Xa inhibitors, trombininhibitors, Vitamin K antagonists Autoimmune disease Intracranial bleeding within the last 6 months Acute coronary syndrome or myocardial infarction within the last 6 months Congestive heart disease Pregnant or breastfeeding Participating in another clinical study within the last 30 days Liver cirrhosis Need for renal replacement therapy

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prostacyclin<br>Treatment with prostacyclin | Drug: Prostacycline<br>* Continuous infusion peri -and 6 hours postoperatively of prostacycline 1 ng/kg/min<br>|
| Placebo Comparator: Isotonic saline<br>Treatment with isotonic saline | Drug: Isotonic saline<br>* same volume as the group that are allocated to prostacycline<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in endothelial biomarkers |  | Baseline to 6 hours postoperatively | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Functional haemostasis evaluated by thrombelastography |  | Baseline to 6 hours postoperatively | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
prostacycline, endothel integrity and abdominal surgery
Effect of Gemcabene on the Pharmacokinetics of Atorvastatin in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the effect of gemcabene on the pharmacokinetics of atorvastatin 80 mg

Official Title
-----------------
A Study of the Effect of Oral, Multiple-Dose 300 mg and 900 mg Gemcabene (CI-1027) Administration on the Steady-State Pharmacokinetics of Atorvastatin 80 mg

Conditions
-----------------
Hypercholesteremia

Intervention / Treatment
-----------------
* Drug: Gemcabene 300 mg
* Drug: Gemcabene 900 mg
* Drug: Atorvastatin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Males and Females 18-65 years of age Good health as determined by medical history, physical examination, vital signs, ECG, and clinical laboratory measurements; Body weight 45 kg or greater, with a body mass index (BMI) ≤ 35 kg/m² (weight [kg]/height[meters]²) Exclusion Criteria: If female, of childbearing potential or lactation History of significant adverse reaction to any lipid-lowering agent

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Gemcabene 300 mg<br>Gemcabene 300 mg | Drug: Gemcabene 300 mg<br>* 1x300 mg gemcabene tablets orally once daily (QD) for 11 days<br>Drug: Atorvastatin<br>* 2x40 mg Atorvastatin tablets orally once daily (QD)<br>|
| Experimental: Gemcabene 900 mg<br>Gemcabene 900 mg | Drug: Gemcabene 900 mg<br>* 3x300 mg Gemcabene tablets orally once daily (QD) for 11 days<br>Drug: Atorvastatin<br>* 2x40 mg Atorvastatin tablets orally once daily (QD)<br>|
| Active Comparator: Atorvastatin 80 mg<br>Atorvastatin 80 mg | Drug: Atorvastatin<br>* 2x40 mg Atorvastatin tablets orally once daily (QD)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics | Cmax | Days 5, 16 and 27 | 
| Pharmacokinetics | Area Under the Curve (AUC) | Days 5, 16, and 27 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse Events |  | 27 days | 
| Clinical Laboratory - hematology, chemistry, urinalysis | Clinical Laboratory Abnormalities | 27 days | 
| ECG | Clinically Significant Changes | 27 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Pharmacokinetics, Lipid Regulator
Peripheral Vascular Disease and Coronary Artery Disease

Study Overview
=================
Brief Summary
-----------------
This study aims at evaluating the relationship between peripheral artery plaque characteristics evaluated by ultrasound and coronary culprit lesion characteristics evaluated by OCT in ACS patients.

Detailed Description
-----------------
Patients with acute coronary syndrome (ACS) who underwent percutaneous coronary intervention (PCI) and optical coherence tomography (OCT) are included in this study. Two skillful echocardiographers will evaluate peripheral artery plaque characteristics by ultrasound.Ultrasound parameters of peripheral artery will be compared among patients with different coronary culprit lesion characteristics, such as plaque rupture and plaque erosion.

Official Title
-----------------
The Relationship Between Peripheral Artery Plaque Characteristics Evaluated by Ultrasound and Coronary Culprit Lesion Characteristics Evaluated by OCT in ACS Patients

Conditions
-----------------
Acute Coronary Syndrome

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosed as ACS underwent coronary angiography and OCT examination Agreed to accept peripheral artery ultrasound examination Exclusion Criteria: In-stent restenosis, coronary dissection, coronary spam, thrombus left main artery disease Age>85 years old Cardiogenic shock or stroke admission Severe hepatic or renal dysfunction Poor quality of OCT image or massive thrombus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Differences in ultrasound parameters of peripheral artery plaque according to different coronary culprit lesion morphology. | Plaque rupture is characterized by the presence of fibrous cap discontinuity with a cavity formation. plaque erosion is characterized by the presence of the attached thrombus overlying an intact and visual plaque, luminal surface irregularity at the culprit lesion in the absence of thrombus, or attenuation of the underlying plaque by thrombus without superficial lipid or calcification immediately proximal or distal to the site of thrombus.Patients with plaque erosion have less plaques, lower intima-media thickness (IMT), lower plaque score (PS) compared to patients with plaque rupture. | Baseline |
A Study Comparing the Efficacy and Safety of Once-Daily Fuzeon (Enfuvirtide) Dosing Versus the Currently Recommended Twice-Daily Dosing in Human Immunodeficiency Virus-Type 1 (HIV-1) Infected Patients

Study Overview
=================
Brief Summary
-----------------
This study will assess the safety and efficacy of once-daily administration of Fuzeon compared with twice-daily administration in HIV-1 infected patients who have received prior treatment. Patients will also receive an optimized treatment consisting of antiretroviral (ARV) therapy as determined by the treating physician. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals.

Official Title
-----------------
A Phase II Open-label, Randomized, Active-controlled Study Comparing the Efficacy and Safety of Once Daily Enfuvirtide Dosing Versus the Currently Recommended Twice Daily Dosing in HIV-1 Infected Treatment-experienced Patients.

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: Optimized Background ARVs
* Drug: enfuvirtide [Fuzeon]
* Drug: enfuvirtide [Fuzeon]


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: HIV-1 infected adults or adolescents >=16 years of age; HIV-1 RNA >=5000 copies/mL; prior experience or documented resistance to each of the 3 currently available classes of ARV drugs (nucleoside reverse transcriptase inhibitors, non-nucleoside reverse transcriptase inhibitors, and protease inhibitors). Exclusion Criteria: history of prior use of Fuzeon or T-1249; female patients who are pregnant or breastfeeding, or who plan to become pregnant during the study; current severe illness; currently taking drugs affecting the immune system, HIV vaccine, or investigational agents for any conditions other than HIV/AIDS.

Ages Eligible for Study
-----------------
Minimum Age: 16 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 |
| --- | --- |
| Experimental: 1<br> | Drug: Optimized Background ARVs<br>* As prescribed<br>Drug: enfuvirtide [Fuzeon]<br>* 180mg sc once daily for 48 weeks<br>|
| Active Comparator: 2<br> | Drug: Optimized Background ARVs<br>* As prescribed<br>Drug: enfuvirtide [Fuzeon]<br>* 90mg sc bid for 48 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Viral load.\n\n |  | Week 48 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| CD4 lymphocyte count. |  | Week 48 | 
| AEs, laboratory abnormalities, local injection site reactions, AIDS-defining events.\n |  | Throughout study |
Metabolic Syndrome Criteria and the Effect of Testosterone Treatment in Young Men With Hypogonadism

Study Overview
=================
Brief Summary
-----------------
The study is designed to answer the following questions: Is hypogonadism a cause for the metabolic syndrome ? What is the effect of testosterone replacement on the metabolic parameters ?

Detailed Description
-----------------
This is a retrospective design, which is performed by investigating the registrations of patients with hypogonadotrophic hypogonadism between the years 2002-2009.

Official Title
-----------------
Phase 4 Study of About the Effect of Testosterone Treatment on the Components of Metabolic Syndrome

Conditions
-----------------
Hypogonadism

Intervention / Treatment
-----------------
* Drug: Testosteron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Men Congenital hypogonadism Treatment Naive Exclusion Criteria: Previous history of androgen replacement Hypertension Diabetes mellitus

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 26 Years

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Testosteron, secondary hypogonadism<br> | Drug: Testosteron<br>* Testosteron 250mg injection per 3-4 weeks for 6 months<br>* Other names: Sustanon 250mg;|

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
-----------------
Metabolic syndrome, Hypogonadism, Testosterone