linjc16/ctgov huggingface dataset:
Trial of Endocrine Against Locoregional Therapy First in Postmenopausal Women With Early Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The hypothesis to be addressed in this randomized phase III trial is that 4 months of letrozole may be superior to surgery as primary therapy for early stage hormone receptor positive breast cancer in postmenopausal women, provided that these patients will receive definitive and radical surgery and adjuvant therapies as otherwise indicated at the completion of preoperative letrozole.

Official Title
-----------------
Randomized Trial of Endocrine Therapy Against Locoregional Therapy First. A DBCG Trial in Postmenopausal Patients With Operable Hormone Receptor Positive Tumors Larger Than 2 cm.

Conditions
-----------------
Operable Breast Neoplasms

Intervention / Treatment
-----------------
* Drug: letrozole (Femara)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Informed consent Age 60 years or older Measurable non-metastatic and non-inflammatory breast cancer Tumor of 2 cm or larger ER and/or PgR positive tumor Co-morbidity index 0 - 3, e.g., no other serious medical condition Exclusion Criteria: Prior medical therapy for a malignant disease, including aromatase inhibitors Distant metastasis Need for chemotherapy Past or current history of other neoplasms (except for curative treated basal skin cancer or in situ carcinoma of the cervix uteri) Treatment with a non-approved drug within 30 days

Ages Eligible for Study
-----------------
Minimum Age: 60 Years

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

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: Postoperative letrozole<br>Definitive surgery without preoperative AI treatment | Drug: letrozole (Femara)<br>* tablet 2.5 mg daily<br>* Other names: Femara;|
| Experimental: Preoperative letrozole<br>Treatment with letrozole for 4 months before definitive surgery. | Drug: letrozole (Femara)<br>* tablet 2.5 mg daily<br>* Other names: Femara;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| pCR | Complete response rate | At four months | 
| Clinical tumor response | Ultrasound | At four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | Death of any cause | At ten years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast neoplasms, Randomised trial, Aromatase Inhibitors, Preoperative care, Age 60 or older, Hormone receptor positive tumor, Tumor lager than 2 cm, No distant metastasis
Improving the Diagnosis of Meningitis in Emergency Rooms

Study Overview
=================
Brief Summary
-----------------
A point-of-care laboratory (POC) was set at North Hospital, Marseille, France for the diagnosis in less than two hours of meningitis caused by known pathogens, close to the reception of Emergency service. In this instance 30% of patients have no etiological diagnosis after the POC diarrhoea tests . This lab has discovered over 200 new species of bacteria in humans, including vector bacteria and opened the field of large Deoxyribonucleic Acid (DNA ) viruses. Also, the laboratory of emerging viruses discovered many Ribonucleic Acid (RNA) viruses transmitted by arthropods. Based on this collection of new pathogens described in POC laboratory, this study proposes to expand the etiological diagnosis strategy of meningitis after POC test.

Conditions
-----------------
Meningitis

Intervention / Treatment
-----------------
* Other: Nasopharyngeal swab


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient admitted at hospital for meningitis requiring, for the emergency physician, a microbiological examination with a POC meningitis kit. Patient who has freely signed the informed written consent Patient affiliated to a social security scheme Exclusion Criteria: Pregnant woman, parturient or nursing Adult patient under guardianship Patient deprived of liberty under court order Patient refusing or unable to sign the informed consent form.
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: Patients diagnosed with clinical meningitis<br>Patients admitted in emergency rooms for clinical meningitis, for which a nasopharyngeal swab will be performed in order to confirm the etiological diagnosis of meningitis | Other: Nasopharyngeal swab<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of patients admitted with a meningitis with a confirmed etiological diagnosis |  | 1 day |
Italian National Study on the Critically Ill Liver Transplant Patient With an Infection

Study Overview
=================
Brief Summary
-----------------
Despite major advances, infections remain one of the major causes of morbidity and mortality in patients undergoing orthotopic liver transplantation (OLT). Furthermore, data on the epidemiology, severity, and type of post-OLT infections nowadays available come from dated, monocentric, retrospective series. Finally, there is no available data focused on the critical OLT patient admitted to the Intensive Care Unit (ICU). Therefore this study was conceived (1) to describe incidence, severity, epidemiology and outcomes of infections recorded in OLT patients in the ICU (first or re-admission ); (2) to identify possible risk factors and (3) to report the type of the involved microorganism with their antibiotic sensitivity pattern

Detailed Description
-----------------
The study will record clinical, epidemiological and microbiological data from the clinical files of OLT patients admitted at italian ICUs

Official Title
-----------------
Italian National Multicenter Study on Infections in the Critically Ill Liver Transplant Recipient

Conditions
-----------------
Liver Transplantation, Infection, Sepsis, Intensive Care Unit

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Age> 18 aa Sex: Both written consent to participate in the study having been undergone to OLT in the 10 years prior to enrollment Infection diagnosis (any type, any localization, any agent) Being admitted in the ICU Exclusion criteria 1. Death within 72 hours of admission 2. Withdrawal of consent -
Sexes Eligible for Study
-----------------
All

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical | number and severity of infectious episodes | 18 months | 
| microbiological | describe the type of infectious agents | 18 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resistance | antibiotic resistance patters of the isolates | 18 months |
Transcutaneous Electrical Stimulation of the Vagus Nerve

Study Overview
=================
Brief Summary
-----------------
This study evaluate the cognitive functions of patient after hip or kneel replacement.Half of the patient will receive transcutaneous vagus nerve electrical stimulation during the surgery while the other half will get placebo therapy

Official Title
-----------------
The Effect of Transcutaneous Electrical Stimulation of the Vagus Nerve on Reduction of Postoperative Cognitive Dysfunction in Elderly Patients After Hip or Knee Arthroplasty

Conditions
-----------------
Cognitive Dysfunction

Intervention / Treatment
-----------------
* Device: transcutaneous vagus nerve electric stimulator


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: over 65 years old ability to communication hip or kneel replacement willing to participate in the study ASA I-II Exclusion Criteria: with cerebral disorders or disease cognitive impairment before surgery with mental disease unable to communication severe eyes or ears impairment surgery performed in the past 30 days Bradycardia，II°AVB，III°AVB，severe heart, liver and kidney dysfunction severe skin disease refuse to enter the study

Ages Eligible for Study
-----------------
Minimum Age: 65 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: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: experiment group<br> | Device: transcutaneous vagus nerve electric stimulator<br>* The stimulator that can be attached to ears of the patient.We suppose that this device can reduce the incidence of perioperative neurocognitive disorders(PND)<br>|
| No Intervention: control group<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of perioperative neurocognitive disorders | make different scale before and after operation to evaluate neurocognitive changes in experiment group and control group. | one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
postoperative Cognitive Dysfunction, hip- and knee arthroplasty, transcutaneous vagus nerve stimulation
To Evaluate Long-Term Safety and Efficacy of Pregabalin in the Treatment of Neuropathic Pain After Spinal Cord Injury.

Study Overview
=================
Brief Summary
-----------------
To evaluate long-term safety and efficacy of pregabalin in the treatment of neuropathic pain after spinal cord injury.

Official Title
-----------------
An Open-Label Extension to Evaluate the Safety and Efficacy of Pregabalin for Treatment of Chronic Central Neuropathic Pain After Spinal Cord Injury.

Conditions
-----------------
Neuropathic Pain

Intervention / Treatment
-----------------
* Drug: Pregabalin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Must have met the inclusion criteria of the preceding double-blind BID study in central pain following spinal cord injury. Must have received study medication under double-blind conditions. Exclusion Criteria: Patients cannot participate if they experienced a serious adverse event during the previous double-blind BID study which was determined to be related to the study medication.

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

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

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

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

Design Details

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


Arms and Interventions

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Efficacy |  |  |
Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer

Study Overview
=================
Brief Summary
-----------------
Patient's anxiety prior to surgery has been linked to more harmful outcome after surgery. The investigators aim to evaluate the effect of video information on preoperative anxiety level in patients with colorectal cancer.

Official Title
-----------------
Effects of Video Information on Preoperative Anxiety in Patients With Colorectal Cancer

Conditions
-----------------
Colorectal Cancer, Video Information

Intervention / Treatment
-----------------
* Other: Short video clip including the circumstance of operation theater, and surgeon's interview


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age: 20-75 Elective surgery Exclusion Criteria: History of previous any surgery emergency surgery dementia psychological disease

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 75 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: watching video<br>Short video clip including the circumstance of operation theater, and surgeon's interview | Other: Short video clip including the circumstance of operation theater, and surgeon's interview<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of APAIS ((Amsterdam preoperative anxiety and information scale) from baseline APAIS to watching video. |  | baseline and 1 minute after watching video. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of HADS (Hospital Anxiety and Depression Scale) from baseline HADS to watching video. |  | baseline and 1 minute after watching video. | 
| Postoperative hospital stay |  | through study completion and an average of 1 year |
No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks

Study Overview
=================
Brief Summary
-----------------
The overall goal of this study is to develop and evaluate a brief, video-based, group-level intervention designed to reduce sexual risk taking among culturally diverse English- and Spanish-speaking Latino men who have sex with men (MSM).

Official Title
-----------------
No Excuses/Sin Buscar Excusas Intervention to Reduce Latino Men's HIV Risks

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

Intervention / Treatment
-----------------
* Behavioral: Video (group-delivered video-based intervention)
* Behavioral: HCT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be between the ages of 18 - 49 Self-identify as Latino or Hispanic Speak English and/or Spanish Reside in NYC and not plan to move in the next 3 months Have had 2 or more sex partners in the last 3 months Have had at least 1 male sex partner in the last 3 months Have engaged in unprotected anal intercourse with at least one male partner in the last 3 months Be HIV negative or not know their status Exclusion Criteria: Participated in a program (research or non-research) during the past 6 months where they have received HIV prevention education (e.g. an in-person or online group session, workshop, support group). Report being HIV-positive

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 49 Years

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

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

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: video<br> | Behavioral: Video (group-delivered video-based intervention)<br>* group-delivered video-based intervention<br>|
| Active Comparator: HCT<br>Offer of HIV counseling and testing | Behavioral: HCT<br>* Offer of HIV counseling and testing<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sexual risk behavior |  | past 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV Seronegativity, HIV risk behavior, Unprotected sex, men who have sex with men, gay, Latino, unsafe sex, high risk sex
Thyroid Dysfunction Induced by Anti-PD-1 Therapy in Patients With Advanced Carcinoma

Study Overview
=================
Brief Summary
-----------------
In this study, we monitored patients with advanced malignant tumors who received anti-PD-1 therapy to observe the characteristic of anti-PD-1 therapy-induced thyroid dysfunction and its correlation with prognosis.

Official Title
-----------------
Study on the Correlation Between Thyroid Dysfunction Induced by Anti PD-1 Therapy and Prognosis in Patients With Advanced Carcinoma

Conditions
-----------------
Carcinoma

Intervention / Treatment
-----------------
* Other: no intervention


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Eighteen years or older Confirmed diagnosis of malignancy Received anti-PD-1 therapy Exclusion Criteria: Thyroid malignancy or history of thyroid malignancy Thyroid dysfunction before anti-PD-1 therapies Previous ICIs treatment Less than 2 cycles of anti-PD-1 treatment No thyroid function monitoring during treatment Known pituitary disease Pregnancy.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Thyroid dysfunction<br>Patients had thyroid dysfunction during anti-PD-1 therapy. | Other: no intervention<br>* This is an observational study so not involved intervention<br>|
| No thyroid dysfunction<br>Patients didn't have thyroid dysfunction during anti-PD-1 therapy. | Other: no intervention<br>* This is an observational study so not involved intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progression-free survival | The time between initiation of anti-PD-1 therapy and disease progression or death, whichever came first. | Through study completion, an average of 17 weeks |
Multimodal Assessment of Knee Conditions in Rehabilitation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to assess ACL injury and other pathological knee conditions from the combination of signals that are known to provide information on the knee joint.

Official Title
-----------------
Multimodal Assessment of Knee Conditions in Rehabilitation

Conditions
-----------------
ACL Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ACL injury Ages 18-40 Female Exclusion Criteria: BMI under 18 BMI over 40 Contraindications to MRI

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| ACL injury subjects<br>Subjects with anterior cruciate ligament injuries. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective evaluation method for knee disorder recovery | ACL injury recovery (confirmed by using MRI) | Six months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Osteoarthritis, ACL injury, Knee trauma, Meniscus tear
Transbronchial Needle Forceps for Endobronchial Ultrasound

Study Overview
=================
Brief Summary
-----------------
Prove the feasibility of a needle forceps in patients with enlarged mediastinal lymph nodes

Detailed Description
-----------------
Patients with enlarged mediastinal lymph nodes must be staged. The EBUS TBNA technique is an established technique. Unfortunately the size of the needle is limited to 21 gauge. With tne new designed needle forceps it should be possible to obtain more material and establish the diagnosis more often

Official Title
-----------------
Transbronchial Needle Forceps for EBUS

Conditions
-----------------
Lung Cancer, Lymph Nodes

Intervention / Treatment
-----------------
* Procedure: EBUS TBNF


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: enlarged mediastinal lymph nodes Exclusion Criteria: comorbidities

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: EBUS TBNF<br>single arm trial, patients with enlarged mediastinal nodes will be examine | Procedure: EBUS TBNF<br>* Transbronchial needle forceps will be use with the EBUS TBNA scope<br>* Other names: Endobronchial ultrasound;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with a positive biopsy result |  | 2 days after intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with Adverse Events as a Measure of Safety and Tolerability |  | 3 weeks after | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
bronchoscopy, endobronchial ultrasound, transbronchial needle aspiration, lung cancer, staging