linjc16/ctgov huggingface dataset:
Focus Cardiac Ultrasound in Patients With Shock

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to analyze in patients with undifferentiated shock, the concordance of initial treatment before and after Focus cardiac ultrasound (FoCUS) in comparison with the reference one established by an adjudication committee

Detailed Description
-----------------
Focus cardiac ultrasound (FoCUS) has already demonstrated its ability to reduce diagnosis uncertainty in patients with undifferentiated shock. However, adequacy of initial treatment has not been investigated. In patients with undifferentiated shock, after clinical evaluation, the physician states its hypothesis and initial treatment intention in closed list. He realizes a FoCUS, states another time the hypothesis and begins treatment according to FoCUS results. An adjudication committee with all the patient's file will state the reference hypothesis and treatment

Official Title
-----------------
Focus Cardiac Ultrasound in Patients With Undifferentiated Shock: Prospective Observational Study

Conditions
-----------------
Shock

Intervention / Treatment
-----------------
* Other: Focus cardiac ultrasound (FoCUS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Undifferentiated shock defined by systolic arterial pressure < 90 mm Hg Exclusion Criteria: hemorrhagic shock cardiac arrest anaphylactic shock documented end-of-life

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

| Intervention/Treatment |
| --- |
|Other: Focus cardiac ultrasound (FoCUS)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| concordance of initial treatment after FoCUS with Kappa coefficient | concordance between initial treatment after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee with Kappa coefficient | Hospitalization duration, up to one month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| duration of FoCUS | concordance between initial diagnosis after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee | Hospitalization duration, up to one month | 
| difficulty of FoCUS | concordance between initial diagnosis after clinical procedure, after FoCUS in comparison with the reference stated by the adjudication committee | Hospitalization duration, up to one month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Shock, emergency, undifferentiated, ultrasound
Effectiveness of a Massage Instrument Compared to Placebo for Upper Trapezius Muscle Pain

Study Overview
=================
Brief Summary
-----------------
The purpose of this study was to determine if using a specialized massage tool was more effective than a placebo treatment in relieving pain in the upper trapezius muscle along the top of the shoulder.

Detailed Description
-----------------
The purpose of the study was to determine if a statistically significant and clinically meaningful difference exits between the FascialEdge tool and placebo in the treatment of latent upper trapezius trigger points.

Official Title
-----------------
Immediate Effectiveness of Instrument Assisted Soft Tissue Mobilization Compared to Placebo on the Sensitivity of Latent Upper Trapezius Trigger Points: A Randomized Double Blind, Placebo-controlled, Parallel-group Study

Conditions
-----------------
Myofascial Pain Syndrome

Intervention / Treatment
-----------------
* Device: FascialEdge instrument
* Other: Placebo electric point stimulation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: male or female between 18-64 years of age a latent trigger point of the upper trapezius muscle Exclusion Criteria: an active trigger point of the upper trapezius muscle rash or infection of the skin over the trigger point neck pain taking anticoagulant drugs spontaneous bleeding long term corticosteroid use

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 64 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: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: FascialEdge tool<br>A massage tool used to loosen adhesions in the superficial fascia | Device: FascialEdge instrument<br>* Stroking massage to patient tolerance over the muscle<br>* Other names: FascialEdge tool;|
| Placebo Comparator: Placebo<br>Detuned electric point stimulation over the upper trapezius trigger point | Other: Placebo electric point stimulation<br>* Detuned electric point stimulation over the involved muscle<br>* Other names: Pointer Plus stimulator;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure pain threshold over the upper trapezius muscles as determined with a pressure pain algometer |  | Within five minutes after initial and only treatment | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Myofascial pain syndrome, Trigger points, Myofascial, Chiropractic, Massage, Musculoskeletal manipulation
Skype for Youth With Poorly Controlled Diabetes

Study Overview
=================
Brief Summary
-----------------
Compared family-based skills training (aka, Behavioral Family Systems Therapy) to youth with poorly controlled type 1 diabetes and their parents either face-to-face or over SkypeTM. Examined the differential impact on the youth's adherence to the diabetes medical regimen and the youth's blood sugar control.

Official Title
-----------------
Improving Health Through SkypeTM: Family-Based Intervention for Teens With Poorly Controlled Diabetes

Conditions
-----------------
Type 1 Diabetes

Intervention / Treatment
-----------------
* Behavioral: BFST


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Youth between the ages of 12 and 18 with type 1 diabetes characterized by an HbA1c value great than 9% Caregivers willing to participate Family members reading English at 5th grade level Willing to be randomized. Exclusion Criteria: Youth with intellectual disability Parent or youth who doesn't speak English

Ages Eligible for Study
-----------------
Minimum Age: 12 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Clinic<br>BFST delivered to youth with poorly controlled diabetes and their families in the clinic, face-to-face. | Behavioral: BFST<br>* Family-based skills training.<br>|
| Active Comparator: Skype<br>BFST delivered to youth with poorly controlled diabetes and their families using Skype. | Behavioral: BFST<br>* Family-based skills training.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| HbA1c | HbA1c values for both intervention groups improved from baseline to 3 months and from 3 months to 6 months. | Change from Baseline to 3 months and from 3 months to 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adherence to diabetes treatment using the Diabetes Self Management Profile (DSMP) (Harris et al, 2001). | DSMP scores for both intervention groups improved from baseline to 3 months and from 3 months to 6 months. | Change from Baseline to 3 months and from 3 months to 6 months |
Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
Tobacco use is the number one killer of Americans today. Most current smokers have tried and failed to quit at least once. Smokers are addicted to the nicotine in tobacco products, and withdrawal from smoking can lead to physical symptoms such as irritability, anxiety, nervousness, depression and insomnia. This study will examine the effects of tobacco cessation counseling and chiropractic treatments on smokers who desire to quit.

Official Title
-----------------
Chiropractic Treatment With Counseling Versus Counseling Alone for Promoting Smoking Cessation: A Randomized Clinical Trial

Conditions
-----------------
Smoking

Intervention / Treatment
-----------------
* Behavioral: Counseling
* Procedure: Chiropractic adjustment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults 18 yrs and above Smokers with desire to quit smoking Exclusion Criteria: Received chiropractic treatment or other manipulative therapies within the last month Have received any therapy for smoking cessation during the last month Visceral, systemic or joint inflammatory disease A history of low back surgery Osteoporosis Prolonged systemic corticosteroid medication Pregnancy Recent spinal fracture

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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Counseling plus chiropractic adjustments<br> | Behavioral: Counseling<br>* Tobacco cessation counseling<br>Procedure: Chiropractic adjustment<br>* Full spine high velocity, low amplitude manipulation of the spine<br>|
| Active Comparator: Counseling alone<br> | Behavioral: Counseling<br>* Tobacco cessation counseling<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tobacco cessation | Has the subject quit smoking? | Smoking diary will be complete for 3 months | 
| Urinary cotinine | An urinary test for nicotine metabolites | Baseline, 14, 30, 60 and 90 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Blood pressure |  | Baseline, 14, 30, 60 days | 
| Weight |  | Baseline, 14, 30, 60 days |
Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to explore how the timing of procedural sedation medications influences patient comfort and satisfaction with sedation. Participation in this study will included be randomly assigned to one of two groups (long and short) within standard of care. Each group will observe a time interval between receiving procedural sedation medications and the start of the procedure. A trained observer will evaluate patient experience during the procedure and at the end of the procedure we will ask the participant 3 brief questions about the experience. All other information collected about the experience during the procedure will occur as part of usual care. No further activities will be asked as part of this study. All study activities will occur during a scheduled visit and participation is complete once questions have been answered.

Official Title
-----------------
Evaluation of Pain and Discomfort in the Cardiac Catheterization Lab

Conditions
-----------------
Patient Comfort

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: English speaking Coming to Duke University for Cardiac Catheterization 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group 1- short interval<br>Less than or equal to six minutes between receiving sedation and the start of the procedure | |
| Group 2- long interval<br>Greater than or equal to seven minutes between receiving sedation and the start of the procedure | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total medication administration dosage as measured by the procedural database |  | During procedure, up to 2.5 hours | 
| Frequency of medication administration as measured by the procedural database |  | During procedure, up to 2.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient satisfaction as measured by Procedural Sedation Assessment Survey (PROSAS) |  | Within 2 hours of procedure | 
| Pain as measured by observation using the Behavioral Pain Assessment Tool (BPAT) |  | During procedure, to 2.5 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Procedural sedation, Cardiac Catheterization
The Jewels in Our Genes Study - an African American Family Study of Breast Cancer

Study Overview
=================
Brief Summary
-----------------
The research team is studying why some African American families have multiple cases of breast cancer. This study will help to better understand if there are undiscovered genes unique to African Americans that may predict early breast cancer risk. Breast cancer survivors AND their relatives who are also breast cancer survivors are being recruited to the study.

Official Title
-----------------
Search for Novel Breast Cancer Susceptibility Genes in Pedigrees of African Ancestry

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Black/African American Ever diagnosed with breast cancer Have at least one living blood relative ever diagnosed with breast cancer, who is also willing to participate Live in the U.S. Exclusion Criteria: Tested positive for BRCA mutations

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 100 Years

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

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 |
| --- | --- | --- |
| breast cancer |  |  |
Optimal Titration Regimen for SBR759 in Lowering Serum Phosphate Levels in Asian Chronic Kidney Disease Patients on Hemodialysis

Study Overview
=================
Brief Summary
-----------------
This study will determine the titration regimen for SBR759 compared to sevelamer HCl in lowering serum phosphate levels in Asian Chronic Kidney Disease patients on hemodialysis

Official Title
-----------------
A 12-week, Open Label, Multicenter, Titration Study, With a 12 Month Extension, to Determine the Optimal Titration Regimen for SBR759, Compared to Sevelamer HCl, in Lowering Serum Phosphate Levels in Asian Patients With Chronic Kidney Disease on Hemodialysis

Conditions
-----------------
Chronic Kidney Disease

Intervention / Treatment
-----------------
* Drug: SBR759
* Drug: Sevelamer HCl
* Drug: Sevelamer HCl
* Drug: Sevelamer HCl


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Men or women of at least 18 years old or 20 years old in Japan. Stable maintenance of hemodialysis 3 times per week. Controlled serum phosphate if under phosphate-binder therapy. Serum phosphate level > 6.0 mg/dL (> 1.9 mmol/L) prior to study treatment initiation. Exclusion criteria Peritoneal dialysis or a non-conventional hemodialysis technique . Parathyroidectomy or transplant scheduled during the study. Uncontrolled hyperparathyroidism History of hemochromatosis or ferritin > 800 µg/L. Clinically significant GI disorder Unstable medical condition other than Chronic Kidney Disease. Treated with sevelamer HCl monotherapy or SBR759. Treated with oral iron. Other protocol-defined inclusion/exclusion criteria may 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>1g bid | Drug: SBR759<br>* 1g tid<br>|
| Active Comparator: 2<br>0.8 g tid | Drug: Sevelamer HCl<br>* 0.8 g tid<br>|
| Experimental: 3<br>1.5 g tid | Drug: Sevelamer HCl<br>* 1.5 g tid<br>|
| Active Comparator: 4<br>1.6 g tid | Drug: Sevelamer HCl<br>* 1.6 g tid<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rates achieving target serum phosphate levels. |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rates in target patients with serum calcium-phosphate levels. |  | Week 12 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Chronic Kidney Disease, hemodialysis, hyperphosphatemia, Asian, patients
CD19 Targeted Universal Chimeric Antigen Receptor T Cells Injection for CD19+ Refractory/Relapsed B-cell Malignancies

Study Overview
=================
Brief Summary
-----------------
It is a single-arm, open-label clinical study to assess the safety and efficacy of the Anti-CD19 Universal CAR-T Cells injection for patients with CD19+ refractory/relapsed B cell acute lymphoblastic leukemia and B cell non-Hodgkin lymphoma.

Detailed Description
-----------------
The study consists of the following periods: screening, lymphodepletion, CAR-T cell infusion, safety follow up, and long term follow-up.

Official Title
-----------------
A Single-Arm, Open-Label Study to Evaluate the Efficacy and Safety of Anti-CD19 Universal CAR-T Cells in the Treatment of CD19+ Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia and Relapsed/Refractory B-cell Non-Hodgkin Lymphoma

Conditions
-----------------
Relapsed or Refractory B-cell Acute Lymphoblastic Leukemia, Relapsed or Refractory B-cell Non-hodgkin Lymphoma

Intervention / Treatment
-----------------
* Biological: Anti-CD19 Universal CAR-T Cells injection


Participation Criteria
=================
Eligibility Criteria
-----------------
Key Inclusion Criteria: Eastern Cooperative Oncology Group Performance Status of 0 or 1； Expected survival time ≥12 weeks; Adequate hematological, renal and liver function; Subjects understand and voluntarily sign the informed consent form. Key Exclusion Criteria: Positive for any of the following etiological tests: HIV, HBV, HCV, TPPA ; Cyclophosphamide or fludarabine is contraindicated for subjects ; Active central nervous system (CNS) involvement by malignancy； Active infection.

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Anti-CD19 Universal CAR-T Cells injection<br>Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion . | Biological: Anti-CD19 Universal CAR-T Cells injection<br>* Anti-CD19 Universal CAR-T Cells injection will be administered by vein after lymphodepletion.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dose Limiting Toxicities | Incidence of dose-limiting toxicities as protocol-defined | Up to 4 weeks after CAR-T infusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Objective response rate (ORR) | Objective response rate after CAR-T infusion | At 4,12,24 weeks after CAR-T infusion |
Long Term Follow up of Small Non-inflammatory Pancreatic Cysts

Study Overview
=================
Brief Summary
-----------------
This study intends to investigate the long term follow-up of small non-inflammatory pancreatic cysts.

Detailed Description
-----------------
This study intends to investigate the long term follow-up of small non-inflammatory pancreatic cysts in a multicenter setting. Inclusion criteria: Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter referred to the University Hospital Hamburg Eppendorf, Israelitic Hospital Hamburg, Sana Klinikum Lichtenberg, Berlin and Krankenhaus Märkisch-Oderland,Strausberg from 2002 to 2007 identified from EUS database. Study design: At least 5 year-long term follow up by inclusion of clinical data, cross sectional imaging if available or actual US findings. Primary outcome: To determine the proportion of patients with increase is size and/or changed appearance Secondary outcomes: Rate of patients undergo pancreatic surgery (indication, histology of resected specimen). Rate of patients undergo FNA (fluid analysis, cytology).

Official Title
-----------------
Long Term Follow up of Small Non-inflammatory Pancreatic Cysts - a Retrospective Multicenter Study.

Conditions
-----------------
Pancreatic Cysts

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with non-inflammatory pancreatic cystic lesions up to 3 cm in diameter Exclusion Criteria: acute or chronic pancreatitis pancreatic cysts > 3 cm Lesion suspicious for malignancy
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 |
| --- | --- | --- |
| Progress of pancreatic cyst | To determine the proportion of patients with increase is size and/or changed appearance of pancreatic cyst. | 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Incidental pancreatic cysts