linjc16/ctgov huggingface dataset:
VIA Disc NP Registry

Study Overview
=================
Brief Summary
-----------------
Registry is to observe and trend patterns of care and outcomes for patients treated with VIA Disc NP.

Detailed Description
-----------------
The Registry is intended to collect data for patients having received treatment with VIA Disc NP.

Official Title
-----------------
VIA Disc NP Registry

Conditions
-----------------
Discogenic Pain, Back Pain, Back Pain, Low

Intervention / Treatment
-----------------
* Biological: VIA Disc NP


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years of age or older Understand and sign the informed consent form (as applicable) VIA Disc NP injection is scheduled for 1 or more levels Exclusion Criteria: VIA Disc NP injection is not performed

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| VIA Disc NP<br>Patients meeting study criteria receiving Vivex VIA Disc NP injection as treatment | Biological: VIA Disc NP<br>* VIA Disc NP - Allograft tissue injection<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reporting of daily function | Change in scores from Oswestry Disability Index (ODI). An index comprising of ten categories of function to quantify disability due to back pain. | 1, 3, 6, 12, 24, & 36 months | 
| Patient self-reported back pain | Change in Numeric Rating Scale (NRS) scores. Eleven point pain scale used for patient self-reporting of back pain, which ranges from 0 (no pain) to 10 (the worst pain imaginable). | 1, 3, 6, 12, 24, & 36 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient self-reported mental health | Change in patient reported anxiety and depression scores. Four question scale used for patient self-reporting of anxiety and depression which ranges from 0-2 (normal), mild (3-5), moderate (6-8), and severe (9-12). | 1, 3, 6, 12, 24, & 36 months | 
| Resource Utilization | Patient reported assessment of healthcare and resources utilized questions to treat ongoing back pain post treatment. | 1, 3, 6, 12, 24, & 36 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
back pain
Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Patients

Study Overview
=================
Brief Summary
-----------------
Participants were classified as normal or malnourished according to anthropometric measures. Serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days.

Detailed Description
-----------------
The investigators enrolled 14 consecutive patients with sepsis. Patients were classified as normal or malnourished according to anthropometric measures. As an additional evaluation of nutritional status, serum albumin and zinc were recovered on the 1st and 7th days of hospitalization. Lymphocyte count was also recorded on the 1st and 7th days. Investigators correlated nutritional status with lymphocyte count and zinc dosage.

Official Title
-----------------
Lymphocyte Count as a Sign of Immunoparalysis and Its Correlation With Nutritional Status in Septic Pediatric Intensive Care Patients: A Pilot Study

Conditions
-----------------
Lymphopenia

Intervention / Treatment
-----------------
* Other: lymphocyte count


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: septic patients Exclusion Criteria: -

Ages Eligible for Study
-----------------
Minimum Age: 1 Month
Maximum Age: 14 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 |
| --- | --- |
| malnourished<br>low zinc, low albumin, anthropometric measures lower than percentile 5 lymphocyte count | Other: lymphocyte count<br>* lymphocyte count<br>|
| well nourished<br>normal zinc, normal albumin, anthropometric measures higher than percentile 5 lymphocyte count | Other: lymphocyte count<br>* lymphocyte count<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| presence of lymphopenia |  | seven days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Nutrition, Lymphocyte Count, Immunoparalysis, nutritional status of septic patients
Computer Intervention for Prevention of Weight Regain

Study Overview
=================
Brief Summary
-----------------
Many overweight patients are able to lose weight successfully, but then regain their weight. The purpose of this study is to develop and test the efficacy of 2 interventions to prevent weight regain in individuals who have recently lost weight. The two interventions being tested are a face-to-face group maintenance program and an Internet intervention. These interventions will be compared to a no-contact control group that receives quarterly newsletters. The primary outcome measure is weight regain from baseline to 18-months.

Conditions
-----------------
Obesity

Intervention / Treatment
-----------------
* Behavioral: Face-to-face maintenance program
* Behavioral: Internet maintenance program


Participation Criteria
=================
Eligibility Criteria
-----------------
10% weight loss in past 2 years

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

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized


Arms and Interventions

| Intervention/Treatment |
| --- |
|Behavioral: Face-to-face maintenance program|nan|
|Behavioral: Internet maintenance program|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
Randomized Study of Growth Hormone on Bone Mineral Density in Patients With Adult Onset Growth Hormone Deficiency

Study Overview
=================
Brief Summary
-----------------
OBJECTIVES: I. Compare whether the bone tissue in the spine and hip improves in patients with adult onset growth hormone deficiency treated with growth hormone (GH) vs placebo. II. Determine whether the blood samples of these patients show evidence of beneficial bone effects after treatment with GH. III. Compare the quality of life of these patients treated with these 2 regimens. IV. Determine the side effects of GH in these patients.

Detailed Description
-----------------
PROTOCOL OUTLINE: This is a randomized, double blind, placebo controlled, multicenter study. Patients are randomized to 1 of 2 treatment arms. Arm I: Patients receive growth hormone subcutaneously (SC) daily for 2 years. Arm II: Patients receive placebo SC daily for 2 years. Quality of life is assessed at the initial eligibility screening, then again within 1 month after the initial screening, and then at 1, 3, and 6 months during study therapy.

Conditions
-----------------
Osteoporosis, Growth Hormone Deficiency

Intervention / Treatment
-----------------
* Drug: growth hormone


Participation Criteria
=================
Eligibility Criteria
-----------------
PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- Diagnosis of adult onset growth hormone deficiency --Patient Characteristics-- Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception

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
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: growth hormone|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
disease-related problem/condition, endocrine disorders, growth hormone deficiency, osteoporosis, quality of life, rare disease
Ziprasidone and Sertraline in PTSD

Study Overview
=================
Brief Summary
-----------------
Serotonin re-uptake inhibitors, such as sertraline, are the medication of choice in post-traumatic stress disorder. However, it takes several weeks before they ameliorate symptoms. Therefore, we will add ziprasidone (vs. placebo) medication during the first four weeks of sertraline in order to find out if this strategy accelerates symptomatic relief.

Detailed Description
-----------------
A current problem in the pharmacotherapy of PTSD is that the medication of choice, serotonin re-uptake inhibitors, take several weeks before they show considerable effects on PTSD symptoms. Addition of typical neuroleptics, such as ziprasidone, offers a potential strategy to bring about a faster symptomatic relief, because they display anxiolytic properties without the risk of dependence. Therefore, in addition to standard sertraline therapy (at least 8 weeks), we will give ziprasidone vs. placebo over the first four weeks in a double-blind randomized design.

Official Title
-----------------
Effects of Ziprasidone vs. Placebo During the First Four Weeks of Eight Weeks Sertraline Treatment in Patients With Post-traumatic Stress Disorder (PTSD)

Conditions
-----------------
Post-traumatic Stress Disorder

Intervention / Treatment
-----------------
* Drug: ziprasidone, sertraline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of Post-Traumatic Stress Disorder Exclusion Criteria: Lifetime psychotic disorders, current substance dependency, gravidity, lactation, tartrazine hypersensitivity, contraindication against sertraline or ziprasidone

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 |
| --- |
|Drug: ziprasidone, sertraline|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Post-Traumatic Diagnostic Scale (PDS) |  | 56 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Beck Depression Inventory (BDI) |  | 56 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ziprasidone, sertraline, PTSD
Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Clinical Study

Study Overview
=================
Brief Summary
-----------------
The Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft Single-Center Study is a clinical trial approved by US FDA to study the safety and effectiveness of the Zenith® p-Branch® and Zenith® Fenestrated AAA Endovascular Graft in the treatment of abdominal aortic aneurysms.

Official Title
-----------------
Study Assessing Safety and Effectiveness of Perivisceral Aortic Aneurysm Treatment With the Zenith® Fenestrated AAA Endovascular Graft and the Zenith® p-Branch® and the Effects on Organ and Extremity Perfusion

Conditions
-----------------
Aortic Aneurysm, Abdominal

Intervention / Treatment
-----------------
* Device: Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Abdominal aortic aneurysm > 5.0 cm or 2 times the normal aortic diameter Abdominal aortic aneurysm with history of growth > 0.5 cm in 6 months Penetrating juxtarenal aortic ulcer > 10 mm in depth and 20 mm in diameter Exclusion Criteria: Age < 18 years Life expectancy < 2 years Pregnant or breast feeding Inability or refusal to give informed consent Unwilling or unable to comply with the follow-up schedule Additional medical restrictions as specified in the Clinical Investigation Plan Additional anatomical restrictions as specified in the Clinical Investigation Plan

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Endovascular<br>Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft | Device: Zenith® p-Branch® or Zenith® Fenestrated AAA Endovascular Graft<br>* Instead of making a large incision in the chest, the physician makes a small incision near each hip to insert, and guides the study device(s) into place in the aorta.<br>* Other names: Stent-graft;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| evaluate perfusion of visceral vessels | evaluate perfusion of visceral vessels (renal, mesenteric, and systemic) | up to 5 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Abdominal aortic aneurysm, Endovascular, Fenestration, Juxtarenal, Off-the-shelf, Pararenal
Nalmefene in Alcohol Dependence and Borderline Personality Disorder

Study Overview
=================
Brief Summary
-----------------
The objective is to study the effectiveness of Nalmefene in decreasing alcohol intake in subjects with alcohol use disorder and comorbid BPD.

Official Title
-----------------
Open-label Trial on Therapeutic Effect and Tolerability of Nalmefene in Subjects With Alcohol Use Disorder and Comorbid Borderline Personality Disorder

Conditions
-----------------
Alcohol Use Disorder, Borderline Personality Disorder

Intervention / Treatment
-----------------
* Drug: Nalmefene


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Alcohol use disorder according to DSM 5 Borderline personality disorder according to DSM 5 CGI-BPD > 3 Female have to use contraception Exclusion Criteria: Other axis I disorders Severe organic disorder Pregnancy or breastfeeding Allergy to Nalmefene Subjects with Opioids use disorder or in treatment with opioid agonists

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 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: Nalmafene<br> | Drug: Nalmefene<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Days of excessive alcohol intake | Excessive alcohol intake: >60 g in males; >40 g in females | 2 months | 
| Daily average intake (grams) | Daily average intake (grams) | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Borderline symptoms on the Borderline Symptom List - 23 (BSL-23) |  | 2 months | 
| Global Impression of the Clinic on the Clinical Impression - BPD (GCI-BPD) |  | 2 months |
Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight Preterm Neonates: A Multi-center Randomized Clinical Trial

Study Overview
=================
Brief Summary
-----------------
The goal of this protocol is to establish a randomized clinical trial comparing the use of cord blood vs. infant blood with the primary outcome of comparing both the absolute hemoglobin concentration and the percent change in hemoglobin concentration from baseline around 24 hours of life.

Official Title
-----------------
Umbilical Cord Blood Use For Admission Blood Tests of Very Low Birth Weight (VLBW) Preterm Neonates: A Multi-center Randomized Clinical Trial

Conditions
-----------------
Anemia

Intervention / Treatment
-----------------
* Procedure: Drawing admission labs from cord blood
* Procedure: Drawing admission labs from infant blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Birth weight less than 1200g or Gestational Age less than 30 weeks born at participating medical centers Exclusion Criteria: No specific exclusion criteria

Ages Eligible for Study
-----------------
Maximum Age: 1 Day

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Infant Blood<br>Control group. Admission labs to be drawn directly from the infant. | Procedure: Drawing admission labs from infant blood<br> <br> |
| Experimental: Cord Blood<br>Admission labs to be drawn from the infant's cord blood | Procedure: Drawing admission labs from cord blood<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Absolute hemoglobin concentration |  | 24 hours of life | 
| Percent change in hemoglobin concentration from baseline |  | 24 hours of life | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number/volume of packed red blood cell (pRBC) transfusions |  | Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks | 
| Number of blood donor exposures |  | Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks. | 
| Use of Vasopressors |  | Participants will be followed from birth until time of hospital discharge, an expected average of 13 weeks. | 
| Hemoglobin concentration at one week of life |  | one week | 
| Hemoglobin concentration at time of hospital discharge |  | Approximately 10 - 16 weeks | 
| Head Ultrasound |  | Read at 7 Days of life and at hospital discharge which is approximately 13 weeks of age |
Registry Measuring Impact of RNA Expression Testing on Treatment Decisions in Early Stage Lung Cancer and Assessing the Disease-free Survival With Long-term Follow-up (ONC006)

Study Overview
=================
Brief Summary
-----------------
This registry is intended to measure the effect of myPlan Lung Cancer™ test has on influencing treatment decisions of Oncologists when added to standard clinical-pathological parameters in patients with early stage NSCLC. The sponsor is conducting two parallel registries, with one directed at Surgeons (ONC003) and the other at Oncologists (ONC006). This registry is specific to Oncologists (ONC006).

Official Title
-----------------
LUNG CAncerREgistry: An Open Registry to Measure the Impact of Adding RNA Expression Testing (myPlan Lung Cancer) on Treatment Decisions and to Assess Disease-free Survival With Long-term Follow-up in Newly Diagnosed Early Stage Lung Adenocarcinoma Patients (LUNG CARE Registry)

Conditions
-----------------
Lung Cancer, NSCLC, NSCLC Adenocarcinoma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Diagnosis of early stage non-small cell lung adenocarcinoma Sub-population staging (IA, IB or IIA) as judged by the standard of practice at the investigational site Resection of tumor within previous 2 months of enrollment ECOG performance of 0-2 A minimum life expectancy of six months Exclusion Criteria Previous myPlan Lung Cancer test performed Pre-operative radiation or chemotherapy for NSCLC Post-operative radiation or chemotherapy for NSCLC Enrollment in a separate clinical trial restricting treatment options Unable to provide informed consent

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage change from Pre-Test treatment recommendation to Post-test treatment initiated | The percentage change from the recorded Pre-Test treatment recommendation by the oncologist versus the Post-Test treatment initiated. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of disease free survival from resection to relapse or death | To estimate disease-free survival with the collection of long-term follow-up information (up to 3 years post-testing). | 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Registry