linjc16/ctgov huggingface dataset:
A Phase II Study of Irinotecan in 3 Line or More Therapy in Local Recurrence or Metastatic Breast Cancer

Study Overview
=================
Brief Summary
-----------------
A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or Metastatic breast cancer patients who recieved anthracycline or taxane drugs. The primary endpoint is Disease Control Rate and Progression free survival. The second endpoint is 3 or 4 grade Adverse Events 、overall survival.All the patients will recieve this therapy till disease progress or other occurrence of withdrawal standards.

Detailed Description
-----------------
A phase II study of irinotecan in 3 line or more therapy in local recurrence or metastatic breast cancer. Evaluate the effect and safety of irinotecan in local recurrence or Metastatic breast cancer patients who recieved anthracycline or taxane drugs. The primary endpoint is Disease Control Rate and Progression free survival. The second endpoint is 3 or 4 grade Adverse Events 、overall survival. irinotecan 100mg/m2,iv,day1,day8,every 3cycles.If no AE happens, increase irinotecan dose to125mg/m2 at the second cycle.All the patients will recieve this therapy till disease progress or other occurrence of withdrawal standards.

Official Title
-----------------
To Evaluate the Clinical Effect of Irinotecan Monotherapy in Treatment of Local Recurrence or Metastatic Breast Cancer Patients Who Accepted at Least 2 Kinds of Chemotherapy Regimens Including Antharcycline or Taxanes.

Conditions
-----------------
Stage IIIB, IV, Recurrent, and Metastatic Breast Cancer

Intervention / Treatment
-----------------
* Drug: irinotecan


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mestatic breast cancer patients whose disease recurrent after using anthracycline or taxane drugs Exclusion Criteria: Heart Disease.etc

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: irinotecan Hydrochloride<br>Irinotecan monotherapy (trade name: Aili; batches 180103AG [40 mg] and 171231AG [100 mg]) will be administered intravenously at a dose of 100 mg/m2 on days 1 and 8 of each 3-week cycle. | Drug: irinotecan<br>* Irinotecan monotherapy (trade name: Aili; batches 180103AG [40 mg] and 171231AG [100 mg]) will be administered intravenously at a dose of 100 mg/m2 on days 1 and 8 of each 3-week cycle.<br>* Other names: Kaiputuo;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Disease Control Rate | Disease Control Rate:Completely Response+Partial Response+Stable Disease | 3cycles (21days/cycle) |
Lipopolysaccharide Binding Protein and Development of Infectious Events in Cirrhotic Patients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether plasma levels of lipopolysaccharide binding protein (LBP) are correlated with PBMN pro- and anti-inflammatory cytokine secretion, as well as with the development of severe infectious events in cirrhotic patients with ascites. As a secondary purpose, the study will evaluate the effect of a prophylactic administration of ciprofloxacin on LBP, cytokines and infections in the same patients.

Official Title
-----------------
Association of Serum Levels of Lipopolysaccharide Binding Protein (LBP) With the Evolution of Pro- and Anti-inflammatory Cytokines, and the Development of Severe Infectious Events in Cirrhotic Patients

Conditions
-----------------
Cirrhosis, Ascites, Infections

Intervention / Treatment
-----------------
* Drug: Ciprofloxacin
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Cirrhosis Ascites No history of spontaneous bacterial peritonitis and/or < 1 g of protein in ascites No antibiotic use in previous 6 weeks Absence of infection (documented by clinical history, blood cytology, urinalysis and urine culture, thorax x-ray and paracentesis) Absence of GI bleeding or encephalopathy Signature of informed consent Exclusion Criteria: Ciprofloxacin contraindication Autoimmune hepatitis, sclerosing cholangitis or other autoimmune disease > 13 Child-Pugh points Inability to attend to regular visits Current alcohol intake Terminal disease with < 24 week expected survival

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active<br>Ciprofloxacin | Drug: Ciprofloxacin<br>* Ciprofloxacin oral, 500 mg capsules, one capsule per day during four weeks.<br>* Other names: Ciproflox;|
| Placebo Comparator: Placebo<br>Placebo | Drug: Placebo<br>* Placebo capsules, one capsule per day during four weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lipopolysaccharide binding protein plasma levels |  | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Severe infection |  | 24 weeks | 
| Pro- and anti-inflammatory cytokine secretion by PBMN cells |  | 24 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Cirrhosis, Ascites, Lipopolysaccharide binding protein, Infections, Cytokines, Ciprofloxacin
Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to remotely monitor individuals who have tested positive for COVID-19 to learn more about progression and recovery from the disease. Individuals who test positive for COVID-19 will wear the Current Health wearable device continuously and answer a brief series of questions on Current Health tablet daily for up to 30 days. The health data will be used to develop predictive models of hospitalization risk.

Official Title
-----------------
Risk Stratification and Early Alerting Regarding COVID-19 Hospitalization

Conditions
-----------------
Covid19

Intervention / Treatment
-----------------
* Device: Current Health


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Living in the United States (contiguous states) Aged 21 years or older Able to provide documentation of +PCR or +antigen test for COVID-19 within the past 48 hours Self-reports that comfortable and willing to wear the wearable device and interact with a tablet-based interface daily Able to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow up. Exclusion Criteria: Under the age of 21 Received a positive test result more than 48 hours prior to contacting study staff or has a pending test for COVID-19 Cannot confirm a PCR or antigen positive test for COVID-19 Is unable to read English Is unwilling to wear the device 24 hours/day except for showering/bathing or interact with a tablet-based interface for daily questionnaire Is unwilling or unable to provide baseline data required for entry into the study Is unable to provide a next of kin/designated person who can be contacted in the event of hospitalization for follow-up Heavy tattooing on both upper arms Known atrial fibrillation (permanent or paroxysmal) Has taken/is taking part in a COVID-19 vaccine or treatment trial

Ages Eligible for Study
-----------------
Minimum Age: 21 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 |
| --- | --- |
| COVID19+<br> | Device: Current Health<br>* wearable device and tablet used to collect health measures at home<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Participant Compliance | a percentage of the number of 15 minute windows with vital sign data compared to the number of 15 minute windows with the potential to have vital sign data. The 15 minute windows with the potential to have vital sign data was calculated based on the number of days the participant was enrolled in the study. There were multiple study endpoints; the number of days varied between 14-30 days. | up to 30 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
wearable, at-home
Very Low Density Lipoprotein (VLDL) Triglyceride Metabolism in Exercise

Study Overview
=================
Brief Summary
-----------------
Purpose: To investigate VLDL-TG metabolism in exercise in healthy volunteers to determine the contribution of VLDL-TG in exercise and eventual gender differences

Official Title
-----------------
Very Low Density Lipoprotein (VLDL) Triglyceride Metabolism in Exercise

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

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Age: 20-50 years Premenopausal Exclusion Criteria: Smoking Alcohol abuse Use of medications

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 50 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Healthy male volunteers | Behavioral: Exercise<br>* Moderate Intensity Exercise (50 % af VO2max) for 90 minutes<br>|
| Experimental: 2<br>Healthy female volunteers | Behavioral: Exercise<br>* Moderate Intensity Exercise (50 % af VO2max) for 90 minutes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VLDL-TG turnover |  | Hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lipid metabolism, VLDL, Exercise, Lipid metabolism in exercise
Global Registry: ExAblate Neuro MR Guided Focused Ultrasound (MRgFUS) of Neurological Disorders:

Study Overview
=================
Brief Summary
-----------------
A global post approval study to collect safety and effectiveness data related to ExAblate Neuro for the treatment of certain disorders such as Essential Tremor, Parkinson's Movement Disorders, or Neuropathic Pain within the thalamus and/or pallidum.

Detailed Description
-----------------
A global, multi-center, open-label, observational registry to capture safety and effectiveness data related to ExAblate Neuro, an MRI guided focused ultrasound device designed to lesion tissue deep within the brain using sound waves without the need for craniotomy. This registry includes certain regional and country specific approved thalamotomy and pallidotomy procedures using ExAblate Neuro for the treatment of various neurologic disorders such as essential tremor, Parkinson's movement disorders, and neuropathic pain. Treatment targets/indications are country/region dependent based on approved labeling within that region.

Official Title
-----------------
Global Registry: ExAblate 4000 Transcranial MR Guided Focused Ultrasound (TcMRgFUS) of Neurological Disorders:

Conditions
-----------------
Essential Tremor, Parkinson's Disease, Movement Disorders, Neuropathic Pain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meets labeling indication for use per information for prescribers Target is accessible by Focused Ultrasound per treatment planning parameters Exclusion Criteria: Do not agree to participate or who are unlikely to participate over an extended period of time
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 |
| --- | --- | --- |
| Clinical Rating Scale for Tremor | CRST | 5 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tremor, Parkinson's, movement, neuropathic, pain
Buccal Mucosal Graft for the Repair of Iatrogenic Pelviureteric Junction Obstruction or Ureteric Stricture.

Study Overview
=================
Brief Summary
-----------------
Prospective study to evaluate the safety and efficacy of using buccal mucosal graft for repairing complex cases of iatrogenic pelvi ureteric junction obstruction and long segment ureteric stricture disease.

Detailed Description
-----------------
A graft of buccal mucosa will be used to augment either the narrow unhealthy pelviureteric junction or a narrow long segment of the ureter. after freeing the narrowed part, a posterior incision will be made in the ureter or renal pelvis then the graft will be implanted on the psoas muscle using interrupted sutures in a position the allows easy anastomosis to the ureter or renal pelvis. Alternatively a lateral incision in the renal pelvis or the ureter may be done for the graft anastomosis and then surrounded with omenal flap to ensure a good blood supply for the graft.

Official Title
-----------------
Using Buccal Mucosal Graft as an Augmention Graft for Complex Cases of Iatrogenic Pelviureteric Junction Obstruction and Long Segment Ureteric Stricture Disease.

Conditions
-----------------
Pelvi Ureteric Junction Obstruction or Ureteral Stricture

Intervention / Treatment
-----------------
* Procedure: buccal mucosal graft to repair iatrogenic PUJO


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: - any patient with iatrogenic pelviureteric junction obstruction or long segment ureteric stricture Exclusion Criteria: elderly patients unfit for general anaesthesia.

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

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

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

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

Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional Model Description: 20 patients with iatrogenic pelviureteric junction obstruction or ureteric stricture disease
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Patients with iatrogenic PUJO<br>patients with iatrogenic PUJO or long segment ureteric stricture disease for safety and efficacy of using buccal graft for repair | Procedure: buccal mucosal graft to repair iatrogenic PUJO<br>* Augmented buccal mucosal graft anastomosis to repair iatrogenic PUJO or long segment ureteric stricture disease<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants with patent renal pelvis and ureter after surgery. | 3 months after surgery Diuretic renography will be done to judge patency of the pelvis and ureter and resolution of hydronephrosis | 3 months |
Clinical Experience With a Tensor Fasciae Latae Perforator Flap Based on Septocutaneous Perforators

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the possible harvest of a tensor fasciae latae flap based on septocutaneous perforators.This study should further confirm our data from an anatomical study concerning location, distribution, diameter and differentiation of the perforators.

Official Title
-----------------
Clinical Experience With a Tensor Fasciae Latae Perforator Flap Based on Septocutaneous Perforators

Conditions
-----------------
Soft Tissue Defect

Intervention / Treatment
-----------------
* Other: septocutaneous perforator flap


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: soft tissue defect no previous operations in the thigh region Exclusion Criteria: obese patients

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 71 Years

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

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

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

Design Details

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: septocutaneous perforator flap|Perforator flaps can be based on septocutaneous or musculocutaneous perforators. If septocutaneous perforators are present, the harvest of these flaps is more straight forward and the dissection of the pedicle is easy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Confirmation of the anatomical data in the clinical trial | Since the purpose of this study was to confirm our anatomical data in a clinical trial, the location, the differentiation and the diameter of the septocutaneous perforators has been measured and recorded during flap elevation. | January 2008 till may 2010 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tensor fasciae latae, septocutaneous perforators
Evaluation of a Rapid Screening Test for Detection of Adenovirus in Tears

Study Overview
=================
Brief Summary
-----------------
To compare the efficacy of a recently FDA approved point of care diagnostic test, the RPS Adeno Detector (Rapid Pathogen Screening, Inc.; South Williamsport, PA), against cell culture for detecting adenoviral conjunctivitis

Official Title
-----------------
A Prospective Blinded Multi-center Clinical Trial to Evaluate the Efficacy of the Recently FDA Approved RPS Adeno Detector for Detecting Adenoviral Conjunctivitis

Conditions
-----------------
Acute Conjunctivitis, Adenoviral Conjunctivitis

Intervention / Treatment
-----------------
* Device: RPS Adeno Detector


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical Study Enrollment Criteria Upon completing the in-vitro studies, a perspective, blinded clinical study was started. Patients who were older than 1 month of age, seen within 7 days of developing a red eye, and who demonstrate at least one criterion from two out of the three categories below were included: I. History: 1) Spread from one eye to the other several days later, 2) recent or concurrent upper respiratory symptoms within the preceding two weeks, 3) or an exposure to someone with pink eye within the preceding three weeks II. Symptoms: 1) Tearing, 2) mucoid or purulent discharge, 3) eye lash matting, 4) burning, 5) itching, or 6) foreign body sensation III. Signs: 1) An inferior palpebral conjunctival reaction with > or = 1+ papillary or follicular reactions, 2) presence of a preauricular node Exclusion Criteria: Patients with associated skin vesicles, corneal dendrites, traumatic corneal abrasion, concurrent corneal ulcers, foreign bodies, ocular pemphigoid, trauma, previous history of chemical/thermal injury to eyes or eyelids (anytime in past), or greater than trace intraocular inflammation were excluded from the study. Additionally, patients with allergy to corn starch, talcum powder, or dacron were also be excluded. Patients using any topical ophthalmic medication (i.e. antibiotics) were required to wait at least 30 minutes from their last dose prior to device application and wait at least 2 hours after their last dose of any ointment application

Ages Eligible for Study
-----------------
Minimum Age: 1 Month

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

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

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

Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: RPS Adeno Detector|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ability to accurately detect presence or absence of adenovirus in conjunctival specimens |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Adenoviral conjunctivitis, Viral conjunctivitis, conjunctivitis
Ileus After Lumbar Spine Surgery

Study Overview
=================
Brief Summary
-----------------
Postoperative ileus (POI) after lumbar spine surgery is not uncommon. However, the incidence, severity and risk factors of ileus after spine surgery remain uncertain because there is not yet a prospective investigation using a subjective grading evaluation tool.

Detailed Description
-----------------
This study aims to prospectively investigate the incidence of POI after spine surgery by using the I-FEED scoring system. The severity of POI after spine surgery thus could be stratified and then an investigation of possible risk factors could be identified.

Official Title
-----------------
Investigation of Postoperative Ileus After Lumbar Spine Surgery: a Prospective Observational Study

Conditions
-----------------
Lumbar Spine Surgery Postoperative Ileus

Participation Criteria
=================
Eligibility Criteria
-----------------
Adult patients who undergoing elective lumbar spine surgery

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 90 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 |
| --- | --- | --- |
| Validation of the I-FEED scoring system | Construct validation of the I-FEED scoring system to ileus-related outcome including the need of gastrointestinal medication, the length of hospital stay and in-hospital cost | 3 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
post-operative ileus,lumbar spine surgery