linjc16/ctgov huggingface dataset:
NOVOCART®3D for Treatment of Articular Cartilage of the Knee

Study Overview
=================
Brief Summary
-----------------
This study is to compare NOVOCART 3D relative to Microfracture for the treatment of knee cartilage defects. Efficacy will be evaluated by both pain and function. Safety will also be evaluated.

Detailed Description
-----------------
Subjects with articular knee defects will be randomized to receive either Microfracture or NOVOCART 3D. Subjects will be followed for five years in total and will be evaluated for safety and efficacy.

Official Title
-----------------
A Phase 3, Prospective, Randomized, Partially Blinded Multi-Center Study to Measure the Safety and Efficacy of NOVOCART 3D Compared ot Microfracture in the Treatment of Articular Cartilage Defects

Conditions
-----------------
Articular Cartilage of the Femoral Condyle Between 2-6cm2

Intervention / Treatment
-----------------
* Procedure: Microfracture
* Biological: NOVOCART 3D


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Greater than 18 years old Isolated articular cartilage lesions on the femoral condyle 2-6 cm2 Minimum score on the KOOS questionnaire Exclusion Criteria: Instability of the knee joint Arthritis Autoimmune disease Immune suppression Prior surgical treatment using mosaicplasty, autologous chondrocyte implantation and/or microfracture (debridement and lavage are acceptable beyond three months from baseline) Bone disease Any degenerative muscular, connective tissue or neurological condition or other disease process that would interfere with healing or the evaluation of outcome measures.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NOVOCART 3D<br>Scaffold assisted autologous chondrocyte Implant | Biological: NOVOCART 3D<br>* combination product- biologic (autologous chondrocytes) /device (scaffold) implant<br>|
| Active Comparator: Microfracture<br>considered a typical treatment for articular cartilage repair | Procedure: Microfracture<br>* Surgical procedure which creates a marrow clot in the prepare cartilage defect.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Knee injury and Osteoarthritis Outcome Score (KOOS) - Pain Subdomain | As measured by a change in KOOS (pain subdomain) score at 24 months from baseline | 24 months post treatment | 
| Knee injury and Osteoarthritis Outcome Score (KOOS) - Function Subdomain | As measured by a change in KOOS score (activity of daily living subdomain) at 24 months from baseline | 24 months post treatment |
The South-Norway Atrial Fibrillation Screening Study

Study Overview
=================
Brief Summary
-----------------
Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke.The aim of this study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF

Detailed Description
-----------------
Atrial fibrillation (AF) is the most common sustained cardiac rhythm disorder. The most serious common complication of AF is ischemic stroke. Many AF cases are undiagnosed due to the asymptomatic and intermittent nature of AF (silent AF). Today there is no simple and inexpensive method of detecting silent AF and thus preventing stroke. The ECG247 Sensor is a new Norwegian digital clinical tool for out-of-hospital self-testing of AF. The innovation project has originated from the University of Agder and Sorlandet Hospital. The COVID19 pandemic is realizing more than ever the need for single-use self-testing out-of-hospital diagnostic tools. The general aim of this open non-randomized study is to investigate the yield of AF screening with a continuous ECG monitor (ECG247) and to estimate the prevalence of silent AF in a cohort of 1500 65-year-old individuals with additional risk factors for stroke. If the study results indicate that easy-to-use continuous AF-screening-devices designed for self-testing can identify people with previously unrecognized AF, this study may contribute to change the approach to screening for AF in the community. Consequently, the study may prevent stroke in the future. By preventing stroke, major personal and socio-economic consequences can be avoided.

Official Title
-----------------
The South-Norway Atrial Fibrillation Screening Study

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Diagnostic Test: AF screening


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >65 years Diabetes, heart failure, hypertension, previous stroke/TIA or other cardiovascular disease (minimum 1 risk factor) Informed written consent for participation Exclusion Criteria: Chronic AF Lack of ability to cooperate

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Examination<br>Continuous ECG monitoring for minimum 3 days | Diagnostic Test: AF screening<br>* Continous ECG monitoring for minimum 3 days<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Prevalence of AF | AF during procedure | During procedure |
Open-Label Study of AXS-07 for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor (EMERGE)

Study Overview
=================
Brief Summary
-----------------
This is a multicenter, open-label trial to evaluate the efficacy and safety of AXS-07 in subjects with migraine attacks and prior inadequate response to oral CGRP inhibitors.

Detailed Description
-----------------
Eligible subjects will receive open-label AXS-07 for up to 8 weeks for at-home treatment of their next 4 migraine attacks.

Official Title
-----------------
An Open-Label, Multiple-Dose Evaluation of the Efficacy and Safety of AXS-07 (Meloxicam and Rizatriptan) for the Acute Treatment of Migraine in Adults With a Prior Inadequate Response to an Oral CGRP Inhibitor

Conditions
-----------------
Migraine

Intervention / Treatment
-----------------
* Drug: AXS-07 (meloxicam-rizatriptan)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Has an established diagnosis of migraine with or without aura Has experienced an inadequate response to oral CGRP inhibitors for the acute treatment of migraine Exclusion Criteria: Pregnant, breastfeeding, or planning to become pregnant during the study Has previously received any investigational drug or device or investigational therapy within 30 days before Screening

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: AXS-07 (meloxicam-rizatriptan)<br>Up to 8 weeks | Drug: AXS-07 (meloxicam-rizatriptan)<br>* AXS-07 tablets, taken orally for the acute treatment of migraine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of subjects with headache pain relief | Absence of headache pain and without the use of rescue medication. | Hour 2 following dose administration | 
| Percentage of subjects with absence of the Most Bothersome Symptom | Absence of the most bothersome symptom, defined at the onset of migraine. | Hour 2 following dose administration | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Migraine, AXS-07, Meloxicam, Rizatriptan, Oral CGRP inhibitor
Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if there are signs of inflammation in one's blood and urine and to find out if one's body size or ethnicity has an effect on these substances.

Official Title
-----------------
Analysis of Microalbuminuria and Markers of Inflammation and Oxidative Stress in Adolescents of Different Ethnic Backgrounds

Conditions
-----------------
Inflammation

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adolescents between 12 to 18 years old Hispanic, African American or Caucasian ethnicity Have a Body Mass Index (BMI) between the 5th and 85th percentile or greater than the 95th percentile Must currently be attending a UC Davis Pediatric clinic Exclusion Criteria: Chronic liver or kidney disease, known Diabetes or other chronic illnesses (such as Sickle Cell Disease or Cystic Fibrosis) Subjects can NOT be acutely febrile, smoke, chronically use prescription medications or oral contraceptive pills.

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare plasma levels of inflammatory markers and urinary biomarkers of oxidative stress in adolescents of Hispanic, African-American and Caucasian ethnicity |  | at the end of study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To determine if there is an independent correlation between these markers and urinary microalbumin excretion |  | at the end of study | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Inflammation, Oxidative Stress, Microalbuminuria
Non-Nicotine Agents for Smoking Cessation

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is to determine which is the better approach to smoking cessation in veterans: bupropion combined with transdermal nicotine or high dose nicotine replacement therapy (NRT) using transdermal nicotine combined with nicotine inhaler.

Detailed Description
-----------------
This study is a two-arm open-label, randomized controlled trial of bupropion combined with transdermal nicotine versus high dose NRT (transdermal nicotine and nicotine inhaler) with all subjects receiving a behavioral counseling program for smoking cessation.

Official Title
-----------------
Non-Nicotine Agents for Smoking Cessation

Conditions
-----------------
Tobacco Use Disorder

Intervention / Treatment
-----------------
* Drug: bupropion and transdermal patch
* Drug: transdermal patch and nicotine inhaler


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Readiness to set a quit date in the next two weeks, Current smoking of at least 15 cigarettes a day Exclusion Criteria: Current untreated depression or receiving treatment for depression, History of seizures, major head injury, or other predisposition for seizures

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 65 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: None (Open Label)


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: bupropion and transdermal patch|nan|
|Drug: transdermal patch and nicotine inhaler|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
-----------------
smoking, nicotine, drug therapy, smoking cessation
Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the accuracy of Amniotic fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity.

Detailed Description
-----------------
Respiratory distress syndrome (RDS) is one of important cause of mortality in neonates. This study was designed to evaluate the amniotic fluid lamellar body counting for predicting fetal lung maturity.

Official Title
-----------------
Study of Accuracy of Amniotic Fluid Lamellar Body Counting for Evaluating of Fetal Lung Maturity

Conditions
-----------------
Retained Fetal Lung Fluid

Intervention / Treatment
-----------------
* Other: Amniotic fluid Lamellar Body Counting


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Women, with 28-37 weeks of gestational age, who had been decided to terminate their pregnancy, were enrolled in the study Exclusion Criteria: Chorioamnionitis Intra Uterine Fetal Death (IUFD) Blood in amniotic fluid Rupture of placenta and patient dissatisfaction were the exclusion criteria.
Sexes Eligible for Study
-----------------
Female

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

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

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Amniotic fluid Lamellar Body Counting<br> | Other: Amniotic fluid Lamellar Body Counting<br>* fluid samples were obtained by amniocentesis during normal delivery or before rupturing the membrane in cesarean. The samples were sent to the lab as soon as possible and after centrifuging with 500 round per minute for 3 minutes, they were placed in the cell counter machine (STKR coulter).<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The statues of respiratory of neonates | Diagnosing of immaturity is based on the following criteria: 1-Physical examinations such as: nasal flaring, retraction, grunting, and tachypnea. 2-Oxygen needing more than 24 hours with three chest x-ray findings. | at 2 minutes after delivery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Respiratory distress syndrome, Lung maturity, lamellar body
Study on the Mechanism of lcn2 in Obesity

Study Overview
=================
Brief Summary
-----------------
Obesity is now becoming a worldwide serious problem. Obesity is associated with a spectrum of severe diseases, including diabetes, cardiovascular diseases, and cancers. Lipocalin 2 (LCN2), also known as neutrophil gelatinase associated lipocalin (NGAL), is a member of the lipocalin family. Due to its upregulated expression in infection, LCN2 is originally considered to be a key regulator of immune response. Subsequent investigations revealed that LCN2 is expressed in many tissues and is related to a variety of diseases, including obesity. LCN2 was reported to be increased in obesity individuals. Thus, the investigators decide to investigate the relationship between LCN2 and obesity.

Official Title
-----------------
Study on the Mechanism of lcn2 in Obesity

Conditions
-----------------
Obesity; Endocrine

Intervention / Treatment
-----------------
* Procedure: LSG


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 1) age ranged from 16-65 years old, 2) BMI over 37.5kg/m2, or BMI over 32.5kg/m2 with diabetes which meets the recommended cut off bariatric surgery of the Guidelines for surgical treatment of obesity accompanied with or without type 2 diabetes in China. Exclusion Criteria: 1) secondary cause of obesity such as hypothalamic obesity, Cushing syndrome, and hypophysis dysfunction, etc.,2)pregnancy or location, 3) contraindications for laparoscopic surgery, such as gastrointestinal diseases of intra-abdominal infection, adhesion, etc., 4) severe heart, liver and kidney dysfunction, 5) organic and systemic diseases intolerant of surgery.

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Procedure: LSG|bariatric surgery|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| LCN2 level | Lipocalin 2 level | 2019-2024 | 
| meet the criteria of metabolism in the 2017 Chinese guideline | Abdominal obesity (or central obesity), male abdominal circumference ≥90cm, female abdominal circumference ≥85cm; | 2019-2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| FBG | patients with fasting blood glucose 6.1mmol/l or more | 2019-2024 | 
| PBG | patients with 2 hour blood glucose 7.8mmol/l or more | 2019-2024 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
obesity, lcn2
Oxaloacetate Pharmacokinetics and Safety

Study Overview
=================
Brief Summary
-----------------
By doing this study, researchers hope to learn how much oxaloacetate (OAA) ends up in the blood after OAA capsules are swallowed, and to assess whether persons with Alzheimer's disease who take OAA for one month have any side-effects.

Official Title
-----------------
Oxaloacetate Pharmacokinetics and Safety

Conditions
-----------------
Alzheimer's Disease

Intervention / Treatment
-----------------
* Dietary Supplement: Oxaloacetate (OAA)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Meet criteria for Mild or Moderate AD Have a study partner Speak English as primary language. Exclusion Criteria: Absence of a study partner Report a potentially confounding, serious medical risk such as type 1 diabetes, cancer, or a recent cardiac event (i.e. heart attack, angioplasty, etc.)

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Oxaloacetate (OAA)<br>100 mg OAA to be taken twice daily over the course of a month | Dietary Supplement: Oxaloacetate (OAA)<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Correlation between oral OAA intake and plasma levels | Baseline blood sample will be obtained before 100 mg OAA is administered. Blood samples to be drawn every 15 minutes starting 30 minutes after OAA administration. | Change from dose to 30, 45, 60, 75, 90, 105, 120, 135, 150, and 240 minutes after dosing | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| safety of OAA in study participants | We will evaluate weights, blood counts, electrolytes, liver function tests, insulin levels, and plasma amino acid levels in subjects exposed to OAA for 1 month. These multiple measures will be used to generate a composite safety outcome measure. | Change from Baseline to Month 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Oxaloacetate, OAA, AD, Alzheimer's Disease
Local Gentamicin Application to Reduce Postoperative Infection Rate

Study Overview
=================
Brief Summary
-----------------
The majority of elderly patients with a displaced fracture of the proximal femur are now treated with a hemiarthroplasty. Prosthetic joint infection is a devastating complication, and the infection rate is high in this group of elderly patients. Local application of gentamicin produces high antibiotic concentrations in the wound. The aim of this study is to determine whether locally administered collagen-gentamicin in the joint perioperatively in addition to routine IV prophylaxis with beta-lactam antibiotics can reduce the early postoperative infection rate (< 4 weeks postoperative)after hemiarthroplasty in proximal femoral fractures.

Official Title
-----------------
Local Gentamicin Application to Reduce Postoperative Infection Rate in Hemiarthroplasty After Fracture of the Proximal Femur: a Randomized Controlled Trial

Conditions
-----------------
Surgical Wound Infection

Intervention / Treatment
-----------------
* Device: Collagen-gentamicin sponge


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinical diagnosis of proximal femoral fracture Must be planned operated with a prosthesis of the hip Exclusion Criteria: Known allergy to gentamicin Ongoing treatment with aminoglycosides Reduced renal function Pregnancy
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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Collagen-gentamicin sponges<br>Two sponges of collagen-gentamicin will be inserted into the hip immediately before closure of the wound. Each sponge (10 by 10 cm) contains 280 mg of collagen and 130 mg of gentamicin. | Device: Collagen-gentamicin sponge<br>* A 10 by 10 cm sponge consisting of 280 mg collagen and 130 mg gentamicin.Two sponges are inserted during hemiarthroplasty surgery, one in the joint and one underneath the fascia at the time of surgical closure.<br>* Other names: Infection prophylaxis in orthopaedic surgery;|
| No Intervention: No intervention<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with postoperatively infection after hemiarthroplasty to evaluate locally administered collagen-gentamicin peroperatively | A randomized multicentre trial | Within 4 weeks after prosthetic surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Humans, Prostheses and Implants, Gentamicin administration and dosage, Surgical sponges, Treatment outcomes