linjc16/ctgov huggingface dataset:
Comparison of 2 Cefazolin Prophylactic Protocol in Laryngectomy Patients

Study Overview
=================
Brief Summary
-----------------
Patients who need major head & neck surgery are at risk of post operative wound infection. In spite of role of antibiotics in prophylaxis of clean contaminated head and neck surgery has been well documented, controversy exists in the optimal antibiotic regimen

Detailed Description
-----------------
Patients undergoing laryngeal oncologic surgery are at relatively high risk of developing complication. Efficacy of cefazolin as a prophylactic antibiotic in head and neck surgery was reviewed in many researches [6] but considering the costs and morbidities of prolonged antibiotic regimen we have presented a prospective and randomized study in 90 patients comparing the efficacy of 2 day over 5 day protocols.

Official Title
-----------------
Double Blind Randomised Study of 2 Days and 5 Days Cefazolin Prophylactic Method in Laryngeal Oncologic Surgery

Conditions
-----------------
Laryngeal Cancer

Intervention / Treatment
-----------------
* Drug: cefazolin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:e. Patients eligible to be included in this trial were those who histologically confirmed squamous cell carcinoma of larynx and hypopharynx and they were candidate of total or partial laryngectomy with or without neck dissection and with negative history of neck or laryngeal radiation were included in this study. Exclusion Criteria: Patients having recurrences or another primary tumor, and those who underwent reconstruction with a flap were excluded from the study, because they had been submitted to prolonged antibiotic administration. Also cases with Diabet mellitus and Immune suppression or tumor types other than squamous cell carcinoma were excluded from the study. In addition, the following exclusion criteria were taken into account: pregnancy, hypersensitivity to penicillins or cephalosporins, patients who received a systemic antibiotic drug within one week prior to the planned procedure, those who had clinical or laboratory evidence of a preexisting infection or had serious systemic renal disease.
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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| wound infection |  | prospective | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| drug complication |  | 3 week after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
clean contaminated, laryngectomy, wound infection
Metabolomics Fingerprinting and Metabolic Dynamics After HIV Infection

Study Overview
=================
Brief Summary
-----------------
The purpose of this plot study is to find out the relationship between metabolic changes and anti-retroviral therapy (ART), life style and clinical conditions of HIV-infected patients using nuclear magnetic resonance (NMR) based systems biology approach and metabolomics methodology.

Detailed Description
-----------------
Since the clinical application of anti-retroviral therapy (ART) in 1997, the life expectancy of HIV infected patients has been prolonged greatly. However,side effects of ART including metabolic abnormalities have become the main factors influencing patients' quality of life. Among which the abnormal lipid metabolism plays an important role. Meanwhile, metabolic conditions differ from patients applying to different combinations of ART drugs,life style and clinical conditions. Metabolomics can measure the dynamic metabolic responses of the body to stimuli or modifications. Using nuclear magnetic resonance (NMR) as tools can systematically analyse the process of lipid metabolism. Metabolomics fingerprinting can be defined as the complete complement of small molecule (< 1500 Da) metabolites found in a specific cell, body fluid, organ or organism. Therefore, the study of the impact of metabolic changes and anti-retroviral therapy (ART), life style and clinical conditions is of importance in enhancing the adherence and improving the clinical outcomes of HIV infected patients.

Official Title
-----------------
Metabolic Fingerprintings and Metabolic Dynamics After HIV Infection:Impact of Metabolic Changes and Anti-Retroviral Therapy, Life Style and Clinical Conditions

Conditions
-----------------
HIV

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of HIV infection Exclusion Criteria: Pregnancy Individual who is participating in other trial(s)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 60 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 |
| --- | --- |
| HIV infectors<br>100 confirmed HIV-1 infected patients who meet inclusion criteria. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dyslipidemia |  | Dyslipidemia events from admission to discharge(Up to 6 months) ) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipoatrophy |  | Lipoarophy events from admission to discharge (up to 6 months) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV, Metabolomics Fingerprinting
Cardiovascular Assessment Before and After Limb Amputation

Study Overview
=================
Brief Summary
-----------------
Vascular lower limb amputees have an increased morbidity and mortality. The aim of the study is to evaluate the hemodynamic changes after amputation and its relation to outcome.

Conditions
-----------------
Diagnostic Techniques, Cardiovascular

Intervention / Treatment
-----------------
* Other: cardiac echo examination


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: all vascular or diabetic patients before leg amputation Exclusion Criteria: traumatic amputation sepsis patient urgent 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: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: cardiovascular<br>cardiac echo | Other: cardiac echo examination<br>* cardiac echo examination - before and after the surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| cardiovascular assessment |  | week | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| complications |  | month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
amputation, vascular, below knee, above knee, cardiovascular, echo, cardiovascular assessment
Evaluation of a LAMP Assay for T. Pallidum. Pertenue

Study Overview
=================
Brief Summary
-----------------
This is a diagnostic evaluation comparing the performance of real-time PCR performed at a national reference laboratory and a LAMP assay performed at a regional hospital for the diagnosis of yaws

Official Title
-----------------
Clinical Evaluation of a Loop-mediated Isothermal Amplification Test for Treponema Pallidum Pertenue: A Diagnostic Tool to Support Yaws Eradication

Conditions
-----------------
Yaws

Intervention / Treatment
-----------------
* Diagnostic Test: PCR
* Diagnostic Test: LAMP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Lesion consistent with yaws Positive treponemal and non-treponemal antibodies assessed by the DPP Syphilis Screen and Confirm RDT Exclusion Criteria: Unable to give consent
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Suspected Yaws Cases<br>Individuals with a lesion clinically suspected to be yaws and with evidence of positive treponemal and non-treponemal serology as assessed by point of care lateral flow tests (DPP Syphilis Screen and Confirm, Chembio) | Diagnostic Test: PCR<br>* qPCR for T.pallidum<br>Diagnostic Test: LAMP<br>* LAMP assay for T.pallidum<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of cases of yaws confirmed by molecular testing | A clinically suspected case of yaws where T.pallidum DNA is detected by PCR or LAMP | 15 Months |
A Clinical Utility Study of PrismRA for Rheumatoid Arthritis

Study Overview
=================
Brief Summary
-----------------
A clinical utility study for PrismRA testing therapeutic response in patients with rheumatoid arthritis.

Official Title
-----------------
A Clinical Utility Study of PrismRA Testing Therapeutic Response for Rheumatoid Arthritis (DRIVE)

Conditions
-----------------
Rheumatoid Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age ≥ 18 at time of consent Satisfies the criteria for RA as defined by the 2010 ACR/EULAR classification at Visit 1 Exclusion Criteria: -

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 |
| --- | --- | --- |
| Therapeutic Response | Proportion of moderate to severe disease activity patients that achieve measurable clinical outcomes therapeutic response after initiation of a non-csDMARD therapy | 12-or 24-weeks |
Opioid Consumption After Knee Arthroscopy

Study Overview
=================
Brief Summary
-----------------
This is a prospective, randomized trial of patients undergoing outpatient knee arthroscopy surgery and receiving a peripheral nerve block. Patients will be randomized to either receive standard discharge teaching or specialized teaching regarding pain control following a nerve block. Patients will be asked to complete a journal for 5 days recording their pain scores, opioid medication usage, and overall satisfaction with pain control at home.

Official Title
-----------------
Opioid Consumption After Knee Arthroscopy With and Without the Use of New Standardized Patient/Family Instructions for Postoperative Analgesic Use

Conditions
-----------------
Surgical Procedure, Unspecified, Orthopedic Disorder

Intervention / Treatment
-----------------
* Other: Standardized instructions
* Other: Conventional instructions


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient of age less than 20 years presenting to NCH main campus for knee arthroscopy American Society of Anesthesiology physical status I or II Exclusion Criteria: Anterior cruciate ligament repair or reconstruction Admission to hospital Inability or refusal to receive femoral nerve blockade Body mass index > 99 percentile Hydrocodone allergy or intolerance Acetaminophen allergy or intolerance Non-steroidal anti-inflammatory allergy or intolerance Pregnancy Interpreter requirement Opioid use within 3 months prior to surgery Previous knee surgery at WSC after Jan. 1, 2017 History of opioid abuse or dependence

Ages Eligible for Study
-----------------
Maximum Age: 20 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 |
| --- | --- |
| Active Comparator: Intervention<br>Patients will receive standardized instruction from a study nurse, tailored to understanding pain management after nerve blocks and maximizing utilization of non-opioid analgesics. | Other: Standardized instructions<br>* Specific instructions related to peripheral nerve block.<br>|
| Other: Control<br>Patient will receive conventional instructions on postoperative pain management. | Other: Conventional instructions<br>* Usual post-operative instructions.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of opioid medication doses taken |  | Post-op day 5 |
Economic Evaluation of Heart Failure Management in Colombian Clinics

Study Overview
=================
Brief Summary
-----------------
Cost effectiveness analysis of local management of patients diagnosed with heart failure disease compared with an ideal guideline-based management.

Official Title
-----------------
Economic Evaluation of Heart Failure Management in Colombian Clinics

Conditions
-----------------
Heart Failure, Asthma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Asthma moderate to severe.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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>moderate to severe uncontrolled asthma | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine cost-effectiveness of Heart Failure management in 3 Heart-specialized clinics in Bogotá Colombia |  | 12 months | 
| Incremental cost-effectiveness ratio from using Symbicort as symbicort as Maintenance and Reliever Therapy (SMART) when compared with its competitive alternatives |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cost-effectiveness analysis, Colombia
Confocal Micro-endoscopy in Head and Neck Cancer/Micro Endoscopie Confocale (MEC)Oto-Rhino-Laryngologie (ORL)

Study Overview
=================
Brief Summary
-----------------
The primary objective is to validate the diagnostic correlation between the intraoperative microendoscopic images and the conventional histological analysis on biopsy and/or surgical specimens on patients with epidermoid carcinoma.

Official Title
-----------------
Clinical Evaluation of Confocal Microscopy in Head and Neck Cancer

Conditions
-----------------
Malignant Pharyngo Laryngeal Tumors, Pre-malignant Pharyngo Laryngeal Tumors

Intervention / Treatment
-----------------
* Procedure: Confocal Micro Endoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with malignant and pre-malignant pharyngo laryngeal tumors in whom direct laryngoscopy was performed under general anesthesia with biopsies for diagnostic or endoscopic removal > 18 years signed ICF Exclusion Criteria: Persons deprived of liberty Patients with history of allergy to patent blue Pregnant women or breastfeeding women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental<br> | Procedure: Confocal Micro Endoscopy<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diagnostic correlation between confocal micro endoscopy and conventional histology |  | at an average of 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Histological diagnostic with confocal micro endoscopy (MEC) VS conventional histological analysis |  | At the time of the biopsy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patients with malignant and pre-malignant pharyngo laryngeal tumors
Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors

Study Overview
=================
Brief Summary
-----------------
PERMED01 is a prospective monocenter clinical trial which aims to evaluate the number patients with locally advanced or metastatic cancer for whom identification of molecular alterations in tumor samples can lead to the delivery of a targeted therapy. PERMED01 will enroll 460 patients in 3 years.

Official Title
-----------------
Identifying Molecular Alterations to Guide Individualized Treatment in Advanced Solid Tumors-PERMED01-IPC 2014-003

Conditions
-----------------
Neoplasm Metastasis

Intervention / Treatment
-----------------
* Procedure: biopsy or surgical sampling
* Other: blood sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age>18 years Histological diagnosis of cancer Locally advanced or metastatic, biopsiable disease ECOG Performans Status ≤2 Affiliation to social security Signed informed consent. Exclusion Criteria: Emergency, Individually deprived of liberty or placed under the authority of a tutor Patients with symptomatic or progressive brain metastasis Patients who have only bone and/or brain metastases Pregnant or breastfeeding women

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Locally advanced /metastatic cancer<br> | Procedure: biopsy or surgical sampling<br> <br> Other: blood sampling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| proportion of screened patients in whom a molecular abnormality for which a targeted therapy exists |  | 4-6 weeks after biopsy | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Molecular Characterization of locally advanced and metastatic malignancies using next generation sequencing |  | 3.5 years | 
| Full exome and transcriptome sequencingof locally advanced and metastatic tumours |  | 6 years | 
| Circulating tumor DNA detection and characterization in locally advanced and metastatic disease |  | 4 years | 
| Circulating Tumor Cells (CTC) detection and characterization in breast cancer | Comparison of three distinct methods for the CTC detection in blood | 3.5 years | 
| Preclinical predictive clinical models validation (limited to breast cancer) | Patient-derived tumour xenograft models (PDX), drug sensitivity tests in vitro | 4 years |
Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation for symptoms and signs of esophageal injury.

Detailed Description
-----------------
The purpose of this study is to prospectively follow the next 200 patients who undergo catheter ablation of atrial fibrillation and endoscopy. If any signs of esophageal injury are seen on endoscopy the patients will be treated with omeprazole and sucralfate and they will have repeat endoscopy in two weeks. Patients who do not have any esophageal injury will be contacted by telephone in two weeks to be assessed for GI symptoms. Specific Aims: The specific aims of the study are to: Assess the incidence of visible transmural esophageal injury following extensive ablation in the posterior left atrium as measured by endoscopy1 Assess whether early detection of esophageal injury by endoscopy and treatment will prevent development of more serious injury such as left atrial-esophageal fistula Identify predictors of esophageal injury. In particular, to assess if esophageal temperature rises during ablation correlate with development of esophageal injury and if the absence of esophageal temperature rise during ablation correlate with the absence of esophageal injury.

Official Title
-----------------
Early Detection and Treatment of Esophageal Injury After Catheter Ablation for Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Procedure: Endoscopy in group I (all patients)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18-80 years Scheduled to have catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. Exclusion Criteria: Contraindication to endoscopy Pregnancy Prisoners Inability or unwillingness to give informed consent

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 |
| --- | --- |
| AF ablation group<br>Patients undergoing catheter ablation of atrial fibrillation or left atrial macroreentrant tachycardia. | Procedure: Endoscopy in group I (all patients)<br>* Post procedure endoscopy, omeprazole 40 mg BID, sucralfate 1 gm BID for 2-4 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of Esophageal Injury as Assessed by Endoscopy | Endoscopy results and clinical status at one month after endoscopy procedure. | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Esophageal injury, Catheter Ablation, Atrial Fibrillation