linjc16/ctgov huggingface dataset:
ITA - Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ in Women With Breast Cancer Treated With NOLVADEX for at Least 2 Years

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen.

Official Title
-----------------
An Open Randomised Clinical Study Comparing ARIMIDEX™ With NOLVADEX™ as Adjuvant Therapies in Post-Menopausal Women With Breast Cancer Already Being Treated With NOLVADEX for at Least Two Years

Conditions
-----------------
Breast Cancer

Intervention / Treatment
-----------------
* Drug: Anastrozole
* Drug: Tamoxifen


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Post-menopausal status; age ≤75 years; histologically confirmed invasive breast cancer with metastases in the axillary lymph nodes; oestrogen receptor status positive or unknown; primary treatment (surgery +/- radiotherapy, +/- chemotherapy) completed Exclusion Criteria: Clinical evidence of metastatic disease (including local or remote recurrence, even if the patient appeared to be in complete remission at the time of randomisation).

Ages Eligible for Study
-----------------
Maximum Age: 75 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 |
| --- | --- |
| Experimental: 1<br>Anastrozole | Drug: Anastrozole<br>* oral<br>* Other names: ZD1033;|
| Active Comparator: 2<br>Tamoxifen | Drug: Tamoxifen<br>* oral<br>* Other names: Nolvadex;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary objective of this analysis was to assess the difference in disease-free survival between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued on tamoxifen |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assess the difference in overall survival/disease recurrence/safety and tolerability between post-menopausal women with hormone receptor-positive early breast cancer who switched from tamoxifen to anastrozole and those who continued to receive tamoxifen. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Breast Cancer
Plan for Systematic Identification of Lung Cancers of Occupational Origin: Implementation Study

Study Overview
=================
Brief Summary
-----------------
The main objective is to identify obstacles and elements facilitating the implementation of a tracking device Broncho Pulmonary Cancer during the course of care. The secondary objective is to assess patient knowledge and information received on their previous occupational exposure during their professional activity. This is a prospective multicenter study of qualitative methodology through in-depth interviews conducted with patients treated at ICLN and CHU Saint-Etienne

Conditions
-----------------
Broncho Pulmonary Cancer

Intervention / Treatment
-----------------
* Behavioral: questionnaire


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: primitive CBP Patients; Patients employees or have been employees of the general scheme and / or the agricultural social security system; Patients understand French. Exclusion Criteria: Patients recognized occupational disease for CBP; recognized disability in patients for CBP by the social security system; Patients who have never been employees of the General or the agricultural social security system plan Patients already included in phase 1 of the study; Refusal of participation, signed consent major patients protected under guardianship; Patients unable to understand the course of 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| filling a questionnaire and interview<br>The questionnaire is tracking occupational carcinogens. It consists of 30 questions , fills an average of 3 minutes and includes three response categories: yes, no and do not know. A questionnaire will be added social and professional issues. Interviews will be conducted with the patient to identify obstacles and facilitating elements | Behavioral: questionnaire<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Interview | Obstacles and elements facilitating the establishment of a work-related bronchopulmonary cancer tracking device during the course of care. These are collected in an interview with a sociologist. It will be analyse with NVivo. | 45 minutes |
Radiomics-based Non-invasive Classifier Research for HCC-related Liver Transplantation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population

Detailed Description
-----------------
Hepatocellular carcinoma is one of the most common malignant tumors in the world with high incidence and mortality. Liver transplantation is the most effective treatment for HCC and is in high demand in China. However, recurrence of HCC among liver transplantation recipients is still a great challenge and threat to the survival of recipients. So it is of great significance to establish a non-invasive way to filter high liver transplantation recipient population before transplantation. Based on large scales of pre-treatment MR images, the investigator's study aims to establish a non-invasive radiomics method to filter high recurrent-risk liver transplantation recipient population. This study will contribute to the precise selection of HCC-related liver transplantation recipients.

Official Title
-----------------
Radiomics-based Non-invasive Classifier Research for HCC-related Liver Transplantation

Conditions
-----------------
Hepatocellular Carcinoma, Liver Transplantation, Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Other: Risk model of tumor relapse


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients had postoperative pathological diagnosis of HCC All patients had underwent contrast-enhanced MRI scan within 2 weeks before liver transplantation Exclusion Criteria: patients whose pathological diagnosis is not HCC patients whose CT images were affected by strong imaging artifacts, i.e. artifacts obscuring more than 10% of whole volume of interest patients whose clinical data or CT images were missing

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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 |
| --- | --- |
| Relapse<br>Relapse of tumor within two years after liver transplantation | Other: Risk model of tumor relapse<br>* High risk factor model of tumor relapse after liver transplantation<br>* Other names: Risk model;|
| Non-relapse<br>Non-relapse of tumor within two years after liver transplantation | Other: Risk model of tumor relapse<br>* High risk factor model of tumor relapse after liver transplantation<br>* Other names: Risk model;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| tumor recurrent status |  | two years |
Evaluating a New Iloperidone Titration Scheme in Bipolar I Disorder or Schizophrenia

Study Overview
=================
Brief Summary
-----------------
This is a single-center open-label study to be conducted in the United States in subjects with bipolar I disorder or schizophrenia.

Official Title
-----------------
A Safety/Tolerance Study to Evaluate a New Titration Scheme in Patients With Bipolar I Disorder or Schizophrenia

Conditions
-----------------
Bipolar I Disorder, Schizophrenia

Intervention / Treatment
-----------------
* Drug: Iloperidone


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female patients 18 to 65 years of age (inclusive) Diagnosed with either schizophrenia or bipolar I disorder, manic or mixed type as per DSM-V criteria Symptomatically stable within the past two months Exclusion Criteria: Exposure to any investigational medication, including placebo, in the past 60 days Non-response to clozapine

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: CYP2D6 non-poor metabolizers<br>titrated up to 24 mg daily (12 mg b.i.d.) | Drug: Iloperidone<br>* Oral Tablet<br>* Other names: VYV-683;|
| Other: CYP2D6 poor metabolizers<br>titrated up to 12 mg daily (6 mg b.i.d.) | Drug: Iloperidone<br>* Oral Tablet<br>* Other names: VYV-683;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The frequency of treatment-emergent adverse events as measured by the number of events |  | 7 days |
Effects of Different Doses of Epinephrine on Biomarkers of Nervous System Ischemia-reperfusion Injury in Patients With Stanford Type A Dissection

Study Overview
=================
Brief Summary
-----------------
Aortic dissection is the most common aortic disease leading to death. Among them, patients with Stanford type A dissection (TAAD) are prone to dissection rupture in the early stage, and their condition deteriorates rapidly. They need immediate surgical treatment after admission.In this study, the detection data of biomarkers of nervous system Ischemia / Reperfusion (I/R)injury in patients with Stanford type A dissection were retrospectively analyzed, and the effects of different doses of adrenaline on biomarkers of nervous system I/R injury were evaluated by statistical methods.The information of 132 patients with Stanford type A aortic dissection who underwent sun's operation in the Department of cardiovascular surgery of the first medical center of the PLA General Hospital from January 2012 to January 2019 was retrospectively analyzed.

Official Title
-----------------
To Explore the Impact of Epinephrine on Biomarkers of Nervous System Ischemia-reperfusion Injury in Patients With Stanford Type A Dissection

Conditions
-----------------
Adrenaline; Aortic Dissection; Drug Dose; Nervous System; Ischemia Reperfusion Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: The patient's age was 18-75 years old; TAAD was diagnosed by aortic CTA before operation; Sun's operation was performed within two weeks of onset; Deep hypothermic circulatory arrest (DHCA) and selective unilateral cerebral perfusion via right axillary artery were used for brain protection; Adrenaline was used after operation Exclusion Criteria: Nervous system disease and mental system disease before operation; Recent acute coronary syndrome; Recent cardiac arrest; Recent poor perfusion of visceral or peripheral organs; Recent hypoxemia; Previous history of cardiac surgery; Intraoperative death and death within 48 hours after operation; Neurological or psychiatric symptoms occurred within 48 hours after operation; Adrenaline was not used after operation

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biomarkers of nervous system ischemia-reperfusion injury | Monoamine oxidase, superoxide dismutase, interleukin-6, tumor necrosis factor- α | 24 hours |
Yoga Chikitsa for Neck Pain Caused by Cervical Spondylosis

Study Overview
=================
Brief Summary
-----------------
Neck Pain caused by Cervical spondylosis (CS) is one of the most common health complaints. Despite its frequency as clinical problem worldwide, there are few evidence-based studies that document efficacy of therapies for neck pain. The aim of this study was to evaluate the effects of Yoga chikitsa (Yoga therapy) on pain and quality of life (QOL) in CS patients compared to usual care.

Official Title
-----------------
Yoga Chikitsa for Neck Pain Caused by Cervical Spondylosis: a Randomized Controlled Pilot Trial

Conditions
-----------------
Cervical Spondylosis

Intervention / Treatment
-----------------
* Other: Yoga Chikitsa
* Drug: Usual care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of CS and confirmed by cervical radiographic examination Neck pain with CS Ready to Consent Exclusion Criteria: Pregnancy Duration of neck pain < 6 months Comorbid systematic condition (Diabetes, Cardiovascular) History of cervical surgery, cervical injury, or disease of bones or joints.

Ages Eligible for Study
-----------------
Minimum Age: 20 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: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Yoga Chikitsa<br>YC group were given traditional combination of yoga therapy including loosening movements, physical postures, breathing, relaxation and yoga counselling. | Other: Yoga Chikitsa<br>* Intervention consisted of combination of static movements, yoga style exercise, yoga postures, breathing practices, relaxation and yoga counselling.<br>* Other names: Yoga therapy;Drug: Usual care<br>* Intervention included pain medications and exercise movements for neck.<br>|
| Active Comparator: Usual Care<br>Usual care were given exercise moves of necks, pain medications prescribed by physicians. | Drug: Usual care<br>* Intervention included pain medications and exercise movements for neck.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Neck Pain | Pain assessed by Northwick Park Neck Pain Questionnaire (NPQ) | Change from baseline to 6 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quality of life | Quality of life assessed by SF-36 questionnaire | Change from baseline to 6 weeks |
Ketoprofen Gel vs Placebo in Children With Ankle Sprain

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyse the effect of ketoprofen gel in children presented with ankle sprain to the emergency department.

Detailed Description
-----------------
Ankle sprains may be associated with soft tissue injuries and fractures. Although diagnostic modalities are important, alleviation of pain is also a part of emergency department management. The aim of this study is to analyse the effect of ketoprofen gel in children presented with ankle sprain to the emergency department.

Official Title
-----------------
Ketoprofen Gel vs Placebo in Children Presented With Ankle Sprain to the Emergency Department: A Randomised Controlled Trial

Conditions
-----------------
Ankle Sprain

Intervention / Treatment
-----------------
* Drug: Ketoprofen
* Other: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with ankle sprain Patients over 8 and lower than 18 years old Exclusion Criteria: Ankle sprain more than 24 hours visual analogue scale score lower than 40mm Allergy to the study drug

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ketoprofen<br>2.5% ketoprofen gel | Drug: Ketoprofen<br>* 2.5% ketoprofen gel<br>* Other names: Fastjel;|
| Placebo Comparator: Placebo<br>Placebo gel | Other: Placebo<br>* Placebo gel<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Visual Analogue Scale | Measurement of pain reduce at 30 minutes by visual analogue scale | 30 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse effects |  | 30 minutes |
ACL Reconstruction With the TLS Technique

Study Overview
=================
Brief Summary
-----------------
This is a non-interventional study to retrospectively validate the technical use TLS (Tape Locking Screw) in the anterior cruciate ligament. The investigators goal is to test the validity of the technique and its positive influence on the resumption of sporting activities in relation to the existing literature.

Official Title
-----------------
ACL Reconstruction With the TLS Technique (Tape Locking Screw) and Return to Sport: Serial 5-year Independent Designers

Conditions
-----------------
Joint Trauma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients over 18 years Patients operated in the service in 2014 to care for end-stage knee osteoarthritis by implantation of a total knee prosthesis. Exclusion Criteria: Patients under 18 years

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 |
| --- | --- | --- |
| Resumption of sporting activities |  | every 3 months over a period of one year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anterior cruciate ligament, Tape Locking Screw, LCA, joint trauma
Study to Compare Differing Dosing Regimens of ISV-303 (Bromfenac in DuraSite) to Xibrom and Vehicle in Post Cataract Surgery Volunteers

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the ocular safety, tolerability, and efficacy in topical administration of differing dosing regimens of ISV-303 compared to vehicle and Xibrom™ when dosed for 2 weeks in post-cataract-surgery volunteers.

Official Title
-----------------
A Randomized Double-masked 14-day Study to Compare the Ocular Safety, Tolerability, and Efficacy of Differing Dosing Regimens of ISV-303 to Vehicle and Xibrom™ in Post Cataract Surgery Volunteers

Conditions
-----------------
Ocular Inflammation

Intervention / Treatment
-----------------
* Drug: ISV-303
* Drug: ISV-303
* Drug: DuraSite Vehicle
* Drug: Xibrom™


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Scheduled for unilateral cataract surgery (phacoemulsification or extracapsular extraction) with posterior chamber intraocular lens implantation on the day prior to study enrollment Meet the best corrected visual acuity score requirement Meet the IOP requirement Additional inclusion criteria also apply Exclusion Criteria: Known hypersensitivity or poor tolerance to bromfenac sodium or any component of the study medications or any of the procedural medications Use of any ocular topical, or systemic medication that could interfere with normal lacrimation, wound healing, the test agent, or the interpretation of study results, within 1 week prior to Day of Surgery Additional exclusion criteria also apply

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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ISV-303 BID<br> | Drug: ISV-303<br>* 0.075% of bromfenac in DuraSite dosed BID<br>|
| Experimental: ISV-303 QD<br> | Drug: ISV-303<br>* 0.075% of bromfenac in DuraSite dosed QD<br>|
| Active Comparator: Xibrom BID<br> | Drug: Xibrom™<br>* 0.09% bromfenac dosed BID<br>|
| Placebo Comparator: DuraSite Vehicle BID<br> | Drug: DuraSite Vehicle<br>* Vehicle dosed BID<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ocular Inflammation | Anterior Chamber Cell Grade 0 at Day 15 measured on a 0 to 4 scale: 0 is 0 cells; 1 is 1-10 cells; 2 is 11-20 cells; 3 is 21-50 cells; 4 is > 50 cells. | 15 days |