linjc16/ctgov huggingface dataset:
Does Static Ultrasound-Preview Reduce the Incidence of Difficult Lumbar Puncture?

Study Overview
=================
Brief Summary
-----------------
Does the use of ultrasound facilitate a lumbar puncture by reducing the number of difficult and traumatic lumbar punctures?

Detailed Description
-----------------
This is a controlled trial randomizing lumbar puncture patients to groups utilizing ultrasound to preview the bony structures of the spine versus using standard palpation technique. The goal is to determine the helpfulness of ultrasound in performing lumbar punctures (to reduce difficult and traumatic lumbar punctures) among patients whose spines cannot be easily visualized.

Official Title
-----------------
Does Static Ultrasound-Preview Reduce the Incidence of Traumatic and/or Difficult Lumbar Puncture? A Randomized Control Trial

Conditions
-----------------
Headache, Meningitis, Subarachnoid Hemorrhage

Intervention / Treatment
-----------------
* Device: Ultrasound


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age greater than 18 Clinical need for lumbar puncture Unable to visualize spine in position for the lumbar puncture Exclusion Criteria: Able to visualize the spinous processes

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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No Ultrasound<br>Standard LP without ultrasound use | |
| Experimental: Ultrasound Use<br>Ultrasound used to assess spine and best location for lumbar puncture. | Device: Ultrasound<br>* Ultrasound used to visualize spine to determine best location for lumbar puncture.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 3 or more needle sticks to successfully complete lumbar puncture |  | We collect the data immediately | 
| Greater than 400 red blood cells in the cerebral spinal fluid |  | Data is obtained within 1 hour when the lab reports the results of the CSF analysis | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
lumbar puncture, headache, traumatic tap
Clinical Benefits of a Blood Glucose Monitoring System in Patients With Type 2 Diabetes

Study Overview
=================
Brief Summary
-----------------
Clinical benefits of the OneTouch® Ultra®2 BGMS versus standard BGMS during 52 weeks of use.

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Behavioral: OneTouch® Ultra®2 System
* Behavioral: Standard care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:· Current diagnosis of type 2 diabetes Diagnosed at least 3 months prior to the start of the study but not more than 15 years from the start of the study Stable regimen (i.e., no changes in therapeutic regimen) for the past three months Baseline HbA1c of 7.0 to 8.9%, inclusive Exclusion Criteria: Using insulin Using oral agents that target post-prandial hyperglycemia (Note: These medications may be added during the study) Known history of anemia or disorders associated with anemia Has previously used the devices being tested in 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?
-----------------

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: OneTouch® Ultra®2 system<br>Test care group assigned to OneTouch® Ultra®2 system | Behavioral: OneTouch® Ultra®2 System<br>* Education and self-monitoring of blood glucose performed with OneTouch® Ultra®2 System that includes the Simple Start™ home-based education program<br>|
| Active Comparator: Standard care<br>Control group receiving standard care with a traditional blood glucose monitoring system | Behavioral: Standard care<br>* Standard education and self-monitoring of blood glucose performed with traditional meter systems<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in A1C From Baseline to Week 52 Between the OneTouch® Ultra®2 and Control BGMS. |  | From baseline to 52 wks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Daily Glycemic Excursions Between the OneTouch® Ultra®2 and Control BGMS. |  | 52 wks |
Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma (RCC) Patients

Study Overview
=================
Brief Summary
-----------------
Capecitabine is an orally-administered chemotherapeutic agent used in the treatment of metastatic breast and colorectal cancers. The role of capecitabine in treatment of metastatic renal cell carcinoma is discussed. In this trial, we are evaluating efficacy of capecitabine in metastatic renal cell carcinoma patients.

Official Title
-----------------
Phase II Study of Capecitabine in Metastatic Non-clear Cell Renal Cell Carcinoma Patients

Conditions
-----------------
Metastatic Renal Cell Carcinoma

Intervention / Treatment
-----------------
* Drug: Capecitabine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: histologically confirmed non-clear cell renal cell carcinoma confirmed metastatic sites no chemotherapy in history Exclusion Criteria: metastases in CNS previous targeted therapy other tumor

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Capecitabine<br>All patients will receive capecitabine. | Drug: Capecitabine<br>* 1,250 mg/m2 orally twice a day, days 1-14<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall response rate |  | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival Progression-free survival |  | 24 months |
Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the efficacy of the AQUABEAM System for the treatment of Lower Urinary Tract Symptoms (LUTS) resulting from Benign Prostatic Hyperplasia (BPH).

Official Title
-----------------
Global Post-Market Registry Using Waterjet Ablation Therapy for Endoscopic Resection of Prostate Tissue

Conditions
-----------------
BPH

Intervention / Treatment
-----------------
* Procedure: Aquablation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male. Subject has diagnosis of lower urinary tract symptoms due to benign prostatic enlargement causing bladder outlet obstruction or in urinary retention. Prostate size ≥ 20 mL and ≤ 150 mL as measure by TRUS. Patient is mentally capable and willing to sign a study-specific informed consent form. Exclusion Criteria: Patients unable to stop anticoagulants, antiplatelet agents, or non-steroidal anti-inflammatory agents (NSAIDs, including aspirin greater or equal to 100mg) prior to treatment per standard of care. History of gross haematuria. Participants using systemic immune-suppressants including corticosteroids (except inhalants), known coagulopathy, or platelet disorder (except aspirin below 100mg/d). Contraindication to both general and spinal anesthesia. Any severe illness that would prevent complete study participation or confound study results. Subject is unwilling to accept a transfusion should one be required.
Sexes Eligible for Study
-----------------
Male

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: Aquablation|Aquablation is a minimally invasive transurethral surgical procedure using the AQUABEAM system, a personalized image-guided waterject resection system that utilizes a high-velocity saline stream to resect and remove prostate tissue.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| IPSS score change |  | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
BPH, Aquablation, AQUABEAM, LUTS
Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Elderly After UDCA Administration

Study Overview
=================
Brief Summary
-----------------
A clinical study to investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

Detailed Description
-----------------
This study has a randomized, open-label, two-treatment, one-sequence, multiple drug administration design. The purpose of this study is as follows; To investigate pharmacokinetics, metabolomics and biomarker in healthy elderly subject after ursodeoxycholic acid administration

Official Title
-----------------
A Randomized, Open-label Clinical Trial to Investigate Pharmacokinetics, Metabolomics and Biomarker in Healthy Elderly Subjects After Ursodeoxycholic Acid Administration

Conditions
-----------------
Aged

Intervention / Treatment
-----------------
* Drug: Ursodeoxycholic Acid


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Subjects aged 70 - 84 years A body mass index (BMI) in the range of 18.5 kg/m2 - 29.9 kg/m2. Good health based on complete medical history, physical examinations, vital signs, electrocardiography (ECG), and clinical laboratory evaluations. Exclusion Criteria: Subjects who have clinically significant disease of cardiovascular, respiratory, renal, endocrinological, hematological, gastrointestinal, neurological(central nervous system), psychiatric disorders or malignant tumor Subject judged not eligible for study participation by investigator

Ages Eligible for Study
-----------------
Minimum Age: 70 Years
Maximum Age: 84 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Ursodeoxycholic acid 400mg<br>Day 1: Ursodeoxycholic acid 400mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid | Drug: Ursodeoxycholic Acid<br>* Day 1: Ursodeoxycholic acid 400mg or 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid<br>* Other names: Ursa tab.;|
| Experimental: Ursodeoxycholic acid 800mg<br>Day 1: Ursodeoxycholic acid 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid | Drug: Ursodeoxycholic Acid<br>* Day 1: Ursodeoxycholic acid 400mg or 800mg qd Day 2 to 15: Ursodeoxycholic acid 200mg bid<br>* Other names: Ursa tab.;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Area under the plasma concentration-time curve (AUC) of ursodeoxycholic acid |  | predose and 2, 4, 5, 7, 9, 10, 12, 24h postdose | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Ursodeoxycholic acid, Metabolomics/biomarker, Pharmacokinetics
Local Anesthetics New Formulations: From Development to Clinical Tests

Study Overview
=================
Brief Summary
-----------------
This blinded cross-over study aim to evaluate the efficacy and the pharmacokinetics of a previously reported liposome-encapsulated mepivacaine formulations.

Official Title
-----------------
Efficacy and Pharmacokinetics of Liposomal Mepivacaine Formulations in Dentistry

Conditions
-----------------
Local Anesthetic Effectiveness

Intervention / Treatment
-----------------
* Drug: mepivacaine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy Exclusion Criteria: Volunteers were free from cardiac, hepatic, renal, pulmonary, neurological, gastrointestinal and haematological diseases, psychiatric disorders and allergy to local anesthetics

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: mepivacaine|One intra-oral injection at four different sessions, of the following formulations: 2% mepivacaine with 1:100,000 epinephrine, 3% mepivacaine, 2% and 3% liposome-encapsulated mepivacaine.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Latency period and duration of anesthesia were assessed by an electrical pulp tester |  | 10 minutes | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma concentrations of mepivacaine |  | 0 to 360 minutes after the injection |
Quality of Life in Patients With Congenital Afibrinogenemia

Study Overview
=================
Brief Summary
-----------------
The aim of this observational study is to evaluate the quality of life in patients with congenital afibrinogenemia using the Haemo-QoL SF for kids and the Haem-A-QoL for adult patients.

Detailed Description
-----------------
In this observational study, children and adults suffering from congenital afibrinogenemia confirmed by biology will be enrolled. All patients will receive a questionnaire on quality of life in their own language during a routine visit and filled out by the patient at home. A general questionnaire will be filled out by the patient's physician.

Official Title
-----------------
Quality of Life in Patients With Congenital Afibrinogenemia

Conditions
-----------------
Afibrinogenemia, Congenital

Intervention / Treatment
-----------------
* Other: Questionnaire quality of life


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Congenital afibrinogenemia confirmed by biology (absence of circulating fibrinogen) and genotype Exclusion Criteria: Lack of participant's consent Patient unable to understand the questionnaire

Ages Eligible for Study
-----------------
Minimum Age: 8 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 |
| --- | --- |
| Afibrinogenemia<br> | Other: Questionnaire quality of life<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The influence of the afibrinogenemia on the patients' quality of life assessed by the Haemo-QoL SF questionnaire (for children) and the Haem-A-QoL questionnaire (for adult) | The quality of life questionnaire includes item assessing: Physical health Feeling View Family Friends Others Sport and school Treatment Perceived support Dealing Future Relationship | At inclusion | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Impact of the afibrinogenemic patient's clinical phenotype on the patients' quality of life | The clinical phenotype will be assessed by a general questionnaire including data on: Bleeding events Bleeding events treatment Thrombotic events Thrombotic events treatment Fibrinogen replacement (type of product and modality of replacement) | At Inclusion | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Congenital fibrinogen disorders
An Observational Study of Patients With Primary Mitochondrial Disease (SPIMM-300)

Study Overview
=================
Brief Summary
-----------------
This is an observational study of patients with Primary Mitochondrial Disease with either signs or symptoms suggestive of myopathy. The Investigator will identify potential patients through existing medical records and one on-site visit.

Detailed Description
-----------------
An observational study of patients with presumed Primary Mitochondrial Disease designed to better characterize and correlate symptoms and signs of myopathy and genetic test results and the use of commonly prescribed treatments. The study will help define and identify a subject population for a future trial of an investigational product to treat primary mitochondrial disease associated with signs and symptoms of myopathy.

Official Title
-----------------
A Prospective Observational Study of Patients With Primary Mitochondrial Disease (SPIMM-300)

Conditions
-----------------
Primary Mitochondrial Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Willing and able to provide a signed informed consent form (ICF) prior to participation in any-trial related procedures Patient has clinical presentation of PMD with either signs or symptoms suggestive of myopathy Patient is ambulatory and able to attempt 6MWT Exclusion Criteria: Patient has symptoms of PMD due to secondary mitochondrial dysfunction Patient has had prior exposure to elamipretide Patient does not have the cognitive capacity to understand and complete all study assessments Patient has a medical history of severe renal impairment History of active alcoholism or drug addiction during the year before enrollment

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 80 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 |
| --- | --- | --- |
| Assess the relationship of genotype to phenotype in patients with Primary Mitochondrial Disease |  | 1 year | 
| Compare local and regional differences in standard of care and management of patients with Primary Mitochondrial Disease |  | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Compare local and regional differences in genetic testing methodologies for Primary Mitochondrial Disease |  | 1 year | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Primary Mitochondrial Disease, Stealth, Myopathy, exercise intolerance, muscle pain, Mitochondrial Myopathy, Primary Mitochondrial Myopathy
Provider Alerts to Reduce Unnecessary Care

Study Overview
=================
Brief Summary
-----------------
10 Clinics within Stanford Health Care are randomized to receive or not receive provider alerts for 5 commonly overused tests and treatments.

Detailed Description
-----------------
10 Clinics within Stanford Health Care are randomized to receive or not receive provider alerts for 5 commonly overused tests and treatments. Thus there will potentially be 50 clinics enrolled across the 5 tests/treatment categories. However, it is expected that some clinics will meet criteria to be one of the 10 clinics in more than test/treatment category. Thus the total number of clinics involved will be between 10 and 50. These 5 tests / treatments are taken from the Choosing Wisely list. All alerts will be provided using the electronic medical record and will be automated.

Official Title
-----------------
Provider Alerts to Reduce Unnecessary Care

Conditions
-----------------
Physician's Role

Intervention / Treatment
-----------------
* Behavioral: Electronic Record Alert


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: High volume clinics defined as the top 10 clinics in Stanford Health Care based on number of electronic orders. Exclusion Criteria: None

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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Provider Alert<br>This arm is the intervention arm. This arm will receive the Electronic Record Alert. | Behavioral: Electronic Record Alert<br>* Electronic alert within the medical record indicating the ordered test or treatment may be inappropriate. The provider can indicate why the test or treatment is appropriate and complete the order.<br>|
| No Intervention: No Provider Alert<br>This arm is the control arm. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of electronic orders entered per 100 clinic patients. | There are five primary outcomes for the five different alerts. For each alert study the outcome will be orders that would qualify for an alert per 100 patients. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of potential electronic alerts divided by the number of electronic orders | There will be five secondary outcomes which will be the alert candidate to order ratio. For both the control and intervention groups we will determine the fraction of orders that qualify for an alert. | 6 months |