linjc16/ctgov huggingface dataset:
Prospective Case Collection Study for New Mammography Technologies

Study Overview
=================
Brief Summary
-----------------
To evaluate the safety and efficacy of the proposed investigational device and assess its clinical utility in breast cancer screening and diagnosis to support continuing technology development of the investigational technology.

Official Title
-----------------
Prospective Case Collection Study for New Mammography Technologies

Conditions
-----------------
Mammography

Intervention / Treatment
-----------------
* Device: Mammography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject is female of any race and ethnicity Subject is at least 35 years old Subject is indicated for a screening or diagnostic mammogram or breast biopsy Exclusion Criteria: Subject is pregnant or thinks she may be pregnant Subject is wheelchair bound and cannot stand independently Subject has breast implants, cardiac pacemakers or IV ports in the mammography field of view Subject previously participated in the study

Ages Eligible for Study
-----------------
Minimum Age: 35 Years
Maximum Age: 100 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Screening Subjects<br>Screening Subjects | Device: Mammography<br>* Hologic pre-market Mammography<br>|
| Other: Subjects recommended for biopsy<br>Subjects recommended for biopsy | Device: Mammography<br>* Hologic pre-market Mammography<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinically acceptable image quality of the Investigational Device. | Questionnaire will be used to measure outcomes | 4 years | 
| Mammograms can be safety acquired on the Investigational Device. | Will be determined using the AE assessment. | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The ease of positioning and usability of the Investigational Device. | Questionnaire will be used to measure outcomes | 4 years | 
| Subject assessment of comfort of the Investigational Device. | Questionnaire will be used to measure outcomes | 4 years |
Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement

Study Overview
=================
Brief Summary
-----------------
To assess the effect of consumption of an oral nutrition supplement on Arginine, a blood marker of nutritional intake

Official Title
-----------------
Appearance of Plasma Amino Acids Following Consumption of an Oral Nutrition Supplement

Conditions
-----------------
Healthy Subjects

Intervention / Treatment
-----------------
* Other: Oral Nutrition Supplement


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy subject (absence of metabolic disorder, heart disease, endocrine disease, cancer) Discontinued use of omega 3 fatty acid supplements - 10 days prior to testing Willing to provide signed informed consent Exclusion Criteria: Smoker Patients with potential for non-compliance Patients with allergy to ingredients in test products (i.e. milk protein, fish oil) Subject who in the Investigator's assessment cannot be expected to comply with study protocol Currently participating in another conflicting clinical trial.

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

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

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

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

Design Details

Primary Purpose: Other
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Impact Advanced Recovery<br>Oral nutrition supplement intended for consumption at 3 servings per day | Other: Oral Nutrition Supplement<br>* Oral nutrition supplement intended for consumption at 3 servings per day<br>|
| Experimental: Impact Advanced Recovery-R<br>Oral nutrition supplement intended for consumption at 3 servings per day | Other: Oral Nutrition Supplement<br>* Oral nutrition supplement intended for consumption at 3 servings per day<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma arginine levels in µmol/L |  | Pre-consumption, 30, 60, 120, 180, 240 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in plasma-free phospholipid Eicosapentaenoic acid (EPA) in µg/ml |  | Pre-consumption, 30, 60, 120, 180, 240 minutes | 
| Change in plasma phospholipid Eicosapentaenoic acid (EPA) in µg/ml |  | Pre-consumption, 30, 60, 120, 180, 240 minutes |
Nonsurgical or Surgical Treatment of ACL Injuries

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to evaluate knee function, sports participation and knee reinjuries over 2 years in a group of patients who choose either nonsurgical or surgical treatment for an anterior cruciate ligament (ACL) injury

Detailed Description
-----------------
This study is a part study of an overall study with the title 'Dynamic stability of the ACL-injured knee'. The overall study prospectively follows a cohort of newly injured patients with total rupture of the anterior cruciate ligament in the knee.

Official Title
-----------------
Dynamic Stability of the ACL Deficient Knee

Conditions
-----------------
Anterior Cruciate Ligament Injury

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Anterior cruciate ligament rupture within 3 months of injury Preinjury participation in level I or II sports at least twice a week Exclusion Criteria: Current or previous injury to the contralateral leg Another grade III ligament injury, fracture, full-thickness articular cartilage damage

Ages Eligible for Study
-----------------
Minimum Age: 13 Years
Maximum Age: 60 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 |
| --- | --- |
| Surgical treatment<br>Patients who undergo rehabilitation and anterior cruciate ligament reconstruction, other surgical interventions may be performed | |
| Nonsurgical treatment<br>Patients who undergo rehabilitation without anterior cruciate ligament reconstruction, other surgical interventions may be performed | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient-reported knee function (IKDC 2000) |  | 2 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Isokinetic knee extensor and flexor muscle strength |  | 2 years | 
| Knee reinjury |  | 2 years | 
| Participation in level I, II and III sports |  | 2 years |
Re-operative Surgery in Children:A Technique for Sternal Re-Entry

Study Overview
=================
Brief Summary
-----------------
Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death.

Detailed Description
-----------------
Background Re-operative surgery in children is extremely challenging and injury to the underlying cardiac structures can occur during sternal re-entry. When institution of cardiopulmonary bypass is required in an emergency, there are often limited sites for peripheral cannulation. Injury to the heart can easily result in catastrophic complications and death. Methods This will be primarily a technique paper. The only clinical data points I am interested in are how many re-operative sternotomies we performed and on how many patients. I will also need to confirm that we did not have any complications due to cardiac injury while opening the sternum. I estimate about 450 patients. Primary Aim: Present an effective technique for sternal re-entry in children Secondary Aim: Present a zero incidence of complicated sternal re-entry over the past 5 years (February 1, 2001 through February 28, 2006) at Children's Healthcare of Atlanta, Egleston Hospital. Inclusion / Exclusion Criteria Any child undergoing re-operative cardiac surgery through a midline sternotomy incision

Official Title
-----------------
Re-operative Surgery in Children: A Technique for Sternal Re-Entry

Conditions
-----------------
Congenital Disorders

Intervention / Treatment
-----------------
* Other: Observation of sternal reentry


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Any child undergoing re-operative cardiac surgery through a midline sternotomy incision Exclusion Criteria: Those who do not fall under the above inclusion criteria

Ages Eligible for Study
-----------------
Maximum 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 |
| --- | --- |
| Observation of Sternal Re-entry<br>All subjects. | Other: Observation of sternal reentry<br>* Observation of sternal reentry<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Present an effective techniqe for sternal re-entry in children. |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
pediatric, cardiac, re-operative surgery
Tumor Immune Mechanism of Axillary Lymph Node Metastasis in Early Luminal Type A Breast Cancer

Study Overview
=================
Brief Summary
-----------------
Luminal type A breast cancer is a type with good clinical prognosis, and the proportion of lymph node metastasis is low, but a small number of patients have more lymph node metastasis when the primary tumor is very small, and the survival is poor, suggesting that this part of Luminal A breast cancer has the different expression of some genes from that of general Luminal A breast cancer, which affects tumor invasion and participates in the occurrence of tumor metastasis. But the mechanism is not clear, especially in the current tumor microenvironment and immune related mechanisms.We want to investigated the relationship of the transcriptional tumor immune microenvironment with early lymph node metastasis among Luminal A type breast cancer.

Official Title
-----------------
The Different Transcriptional Characterization Of The Tumor Immune Microenvironment of Luminal A Breast Cancer With Different Lymph Node Metastasas Status

Conditions
-----------------
Immune Microenvironment, Luminal A, Lymph Node Metastases

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


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: invasive breast cancer with Luminal A type;T1 with positive lymph node or T2/T3 with negative lymph node Exclusion Criteria: Missing specimen
Sexes Eligible for Study
-----------------
Female

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| T1N+<br>T1 tumor with positive lymph node,N1/N2/N3 | Other: no intervention<br>* no intervention<br>|
| T2/T3N0<br>T2/T3 tumor with negative lymph node | Other: no intervention<br>* no intervention<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Transcriptional Characterization | the relationship of the transcriptional tumor immune microenvironment with lymph node metastases in Luminal A breast tumor;Differences in RNA copy numbers of different genes （using IO Panel） between the two groups of patients | 2020-12 |
What is an Important Change in the Short Physical Performance Battery (SPPB)?

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the important change in the Short Physical Performance Battery (SPPB) when used in patients with lung disease. The SPPB is a simple physical test that measures balance and the functioning of the legs. It has been widely used in healthy elderly populations and predicts hospital admission and the onset of disability. The SPPB has not previously been used in patients with lung disease, and it is not clear what change in this test is considered meaningful and worthwhile by patients or doctors (the minimal clinically important difference: MID). Knowing what the MID for the SPPB will allow researchers and doctors to evaluate the effectiveness of current and new treatments, and to detect improvement or deterioration in the condition of patients.

Official Title
-----------------
Determining the Minimal Important Difference of the Short Physical Performance Battery and 4m Gait Speed in Chronic Respiratory Disease Patients.

Conditions
-----------------
Respiratory Tract Diseases, Lung Diseases

Intervention / Treatment
-----------------
* Other: Pulmonary rehabilitation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients entering pulmonary rehabilitation Exclusion Criteria: Any patient in whom mobility and lower limb function have been significantly affected by a neuromuscular cause, severe peripheral vascular disease or amputation. Any patient whom the chief investigator feels it is unsafe to exercise (e.g. unstable cardiac disease).
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Chronic Respiratory Disease<br>Any patient with a chronic respiratory disease referred for pulmonary rehabilitation | Other: Pulmonary rehabilitation<br>* An eight week out-patient based programme consisting of twice weekly supervised exercise and educational sessions<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of Short Physical Performance Battery |  | 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline of MRC Dyspnoea Scale |  | 8 weeks | 
| Change from baseline of St George's Respiratory Questionaire |  | 8 weeks | 
| Anchor question (5-point Likert scale) |  | 8 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Rehabilitation [E02.831], Exercise [G11.427.394.380], Health Education [I02.233.332], [C08], [C08.381]
Study to Determine Pediatric Bladder Volume Prior to Catheterization

Study Overview
=================
Brief Summary
-----------------
This is a randomized controlled trial evaluating the effectiveness of bedside volumetric bladder ultrasound prior to transurethral catheterization of pediatric patients presenting to an emergency department with suspected urinary tract infection. Ultrasound prior to catheterization allows Emergency Physicians to determine if the urine volume of the bladder is sufficient for successful catheterization. Advance knowledge of insufficient urine allows the Emergency Physician to defer the procedure until success is likely.

Official Title
-----------------
Pediatric Volumetric Bladder Ultrasound Study

Conditions
-----------------
Urinary Tract Infection

Intervention / Treatment
-----------------
* Procedure: Ultrasound prior to bladder catheterization


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children 0-36 months of age Require urethral catheterization for urine analysis Exclusion Criteria: Recently voided and unlikely to provide sufficient urine when catheterized Documented or suspected genitourinary abnormalities precluding urethral catheterization Indwelling catheter or urostomy Critical illness No available legal guardian or legal guardian does not understand English well enough to provide informed consent Technical failure of the utlrasound equipment

Ages Eligible for Study
-----------------
Maximum Age: 36 Months

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ultrasound<br>Bladder ultrasound prior to catheterization | Procedure: Ultrasound prior to bladder catheterization<br>* Bedside ultrasound to estimated volume of urine in bladder<br>|
| No Intervention: Standard catheterization<br>No ultrasound prior to bladder catheterization | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of patients in each arm from whom at least 2 ml of urine is obtained on first attempt at catheterization. |  | First feasible attempt at catheterization during ED visit (minutes-hours). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ultrasound, Urethral catheterization, Emergency Department, Urinary tract infection, Pediatric
Multiple Oral Dose Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691

Study Overview
=================
Brief Summary
-----------------
To assess the safety, tolerability, pharmacokinetics and pharmacodynamics of multiple oral doses of PF-04878691.

Official Title
-----------------
A Phase 1, Randomized, Placebo Controlled, Blinded (3rd Party Open), Sequential, Multiple-Dose Escalation Study To Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of PF-04878691 In Healthy Volunteers

Conditions
-----------------
Hepatitis C Virus

Intervention / Treatment
-----------------
* Drug: PF-04878691 3mg
* Drug: PF-04878691 6mg
* Drug: PF-04878691 9mg


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy male and/or female subjects between the ages of 18-55, inclusive. Body Mass Index (BMI) of 18-30 kg/m2; total body weight >50kg (110lbs). Exclusion Criteria: Pregnant or nursing females. Females of child-bearing potential. Evidence of history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, allergic or autoimmune disease or clinical findings at screening. Smoking within the previous 6 months.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 55 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PF-04878691<br> | Drug: PF-04878691 3mg<br>* Oral solution, 3mg, twice weekly, 2 weeks<br>Drug: PF-04878691 6mg<br>* Oral solution, 6mg, twice weekly, 2 weeks<br>Drug: PF-04878691 9mg<br>* Oral solution, 9mg, twice weekly, 2 weeks<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the safety and toleration of multiple ascending oral doses of PF-04878691 |  | 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the pharmacokinetics and pharmacodynamics with regards to specific biomarkers of immune stimulation of PF-04878691 |  | 3 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Toll-like receptor 7, Multiple oral dose escalation study of PF-04878691, HCV