linjc16/ctgov huggingface dataset:
A Study of the Safety and Performance of the MINITAC◊ Titanium 2.0 Suture Anchor

Study Overview
=================
Brief Summary
-----------------
This is a retrospective study evaluating the safety and performance of the MINITAC Suture anchors for extremities repair. Data will be used to support Notified Body (BSI) requirements for extremities repair indications.

Detailed Description
-----------------
Up to 3 sites will participate in the study across Australia and the EU, collectively enrolling a minimum of 30 and a maximum of 50 subjects into the study.

Official Title
-----------------
Safety and Performance of MINITAC◊ Ti 2.0 Suture Anchor in Extremities

Conditions
-----------------
Hallux Valgus Repairs, Medial or Lateral Instability Repairs/Reconstructions, Achilles Tendon Repairs/Reconstructions, Midfoot Reconstructions, Metatarsal Ligament/Tendon Repairs/Reconstructions, Scapholunate Ligament Reconstructions, Ulnar or Radial Collateral Ligament Reconstructions, Lateral Epicondylitis Repair, Biceps Tendon Reattachment

Intervention / Treatment
-----------------
* Device: MINITAC Ti 2.0 suture anchor


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subject has undergone extremities repair using the MINITAC◊ Ti 2.0 Suture Anchor. Subject was ≥ 18 years of age at time of surgery. Subject status is > 12 months post-operative. Exclusion Criteria: Subject is entered in another investigational drug, biologic, or device study or has been treated with an investigational product within 12 months post-operative.

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 |
| --- | --- |
| Minitac Ti 2.0 suture anchor<br>Subjects who have undergone extremities repair using the Minitac Ti 2.0 Suture anchor | Device: MINITAC Ti 2.0 suture anchor<br>* The MINITAC◊ Ti 2.0 Suture Anchor is intended to provide secure reattachment of soft tissue to bone in the foot and ankle as well as elbow, wrist and hand.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 6 Months Post-operative | Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon. | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Success Rate (%) of the MINITAC◊ Ti 2.0 Suture Anchor in Extremities at 12 Months Post-operative | Clinical success defined as extremity repairs without signs of device failure and/or reintervention as assessed by the surgeon for all participants that completed the 12-month visit | 12 months |
A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring

Study Overview
=================
Brief Summary
-----------------
The purpose of this research study is to test a new approach for treating patients with obstructive sleep apnea and/or snoring. The new nasal device, nastent (NAS: nasal airway stent), appears to be a useful alternative or additive treatment.

Detailed Description
-----------------
The nasal stent basically helps to splint the soft palate open. Subjects have a baseline (diagnostic) sleep study without wearing the device. Subjects are then fitted with the device and then subjects wear the device for at least 7 nights during their sleep while at home. Subjects then return for a repeat in-laboratory sleep study while wearing the device. The primary outcome is to assess the effectiveness of the device by change in the apnea-hypopnea index (number of sleep-related abnormal breathing events per hour of sleep) while wearing the device compared to baseline.

Official Title
-----------------
A Disposable Device NAS to Treat Obstructive Sleep Apnea and Snoring

Conditions
-----------------
Obstructive Sleep Apnea, Snoring

Intervention / Treatment
-----------------
* Device: Nastent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults that are 18 years of age or older who had a prior sleep-study within the past 6 months that confirmed a diagnosis of obstructive sleep apnea, and with body mass index less than 30 kg/m2. Exclusion Criteria: Children, pregnant women, homeless, economically disadvantaged individuals, and those who are unable to comprehend or understand English, or follow instructions were excluded. Persons with body mass index equal or greater than 30 kg/m2 were excluded.

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Nastent<br>A baseline sleep study is obtained from the subject, without wearing the device. The individual wears the device at home for at least 7 nights, and then returns to the sleep lab for an in-laboratory sleep study while wearing the device. | Device: Nastent<br>* Use of the device while at home and in the sleep lab<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Apnea-Hypopnea Index (AHI) | Abnormal breathing events (apneas = complete pauses in oronasal airflow; hypopneas = decreases in oronasal airflow) per hour of sleep. This is measured through polysomnography (sleep study) by a nasal thermistor and oral pressure sensor. | In-lab sleep study obtained at least 7 nights following use of the device at home |
Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT

Study Overview
=================
Brief Summary
-----------------
To evaluate whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation

Detailed Description
-----------------
53 patients who ready to wean from mechanical ventilation were included in this study. The changes of lung tidal distribution during SBT with mechanical ventilation by EIT were recorded. Whether EELI, RVD, GI were good predictor for weaning from mechanical ventilation?

Official Title
-----------------
Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT

Conditions
-----------------
Mechanical Ventilation

Intervention / Treatment
-----------------
* Diagnostic Test: Assessment of Lung Tidal Distribution With EIT


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Intubated patients age between 18 years old and 80 years old Duration of controlled mechanical ventilation≥ 24 h Patients ready to wean from mechanical ventilation Informed consent Exclusion Criteria: Pregnant women Patients with malignant tumor High paraplegia, neuromuscular lesions Thoracic deformity, diaphragmatic hernia Patients with ECMO Patient participated in another interventional trial before enrollment

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Weaning Guide by EIT<br>Weaning From Mechanical Ventilation Guide by Assessment of Lung Tidal Distribution With EIT | Diagnostic Test: Assessment of Lung Tidal Distribution With EIT<br>* Changes of lung tidal distribution during SBT with mechanical ventilation were recorded by EIT can be used to predict weaning success or failure<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weaning duration | Time of weaning duration from SBT to weaning from mechanical ventilation | 48 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Weaning, Mechanical ventilation, Electrical impedance tomography, Tidal distribution
Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines

Study Overview
=================
Brief Summary
-----------------
This trial is designed to evaluate safety, tolerability and immunogenicity of a bedside mixing formulation of adjuvanted influenza vaccines.

Official Title
-----------------
A Phase I, Observer-Blind, Randomized, Single-Center Study to Evaluate Safety, Tolerability and Immunogenicity of a Bedside Mixing Combination of Two Adjuvanted Influenza Vaccines in Healthy Adults Aged 18 to 39 Years.

Conditions
-----------------
Influenza

Intervention / Treatment
-----------------
* Biological: Adjuvanted Influenza Vaccine
* Biological: Influenza Vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy 18 to 39 year old males and females who are in good health and have provided informed consent prior to enrollment Exclusion Criteria: serious medical conditions allergies to vaccine components, including but not limited to egg/chicken products reduced immune function recent use of immunosuppressive therapy recent use of influenza vaccine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 39 Years

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Biological: Adjuvanted Influenza Vaccine<br>* 1 dose of Adjuvanted Influenza Vaccine<br>|
| Active Comparator: 2<br> | Biological: Influenza Vaccine<br>* 1 dose of Influenza Vaccine<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety as measured through local and systemic reactions and efficacy (immunogenicity) as measured by antibody titers. |  | 36 Days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To evaluate immunogenicity of a single IM injection of adjuvanted Influenza vaccine |  | 36 Days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
influenza, vaccine, adjuvants, flu
Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Bleeding at Cesarean

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether the effect of sublingual misoprostol is better than infusion oxytocin in reduction of blood loss at cesarean deliveries.

Detailed Description
-----------------
A total of 180 pregnant women with gestational age 37 weeks and over who underwent cesarean operation in Imam Reza hospital had elective or emergency procedure with incision in lower segment during one year recruitment. The patients were randomly assigned to undergo 200 micrograms misoprostol sublingual or 400 micrograms and infusion 20 unit oxytocin after spinal anesthesia. Main outcome measures: The length of surgery, bleeding volume, the need for transfusion, fever, tachycardia, and hypotension.

Official Title
-----------------
Phase 2-3 Study of Comparative of Effects of Sublingual Misoprostol and Infusion Oxytocin in Reduction of Blood Loss at Cesarean Deliveries

Conditions
-----------------
Bleeding Intraoperative

Intervention / Treatment
-----------------
* Drug: Misoprostol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Indication of Cesarean Deliveries Elective or Emergency with Incision in Lower Segment in Women with Gestational Age more than 37 Weeks. Exclusion Criteria: Anemia Multiple Pregnancy Polyhydraminus Prolonged Labor Premature Rupture of Membrane and Patients had Previous History of Diabetes Mellitus Hypertension Cardiovascular Disease Coagulopathy Disease

Ages Eligible for Study
-----------------
Minimum Age: 15 Years
Maximum Age: 44 Years

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

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

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

Design Details

Primary Purpose: Prevention
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Misoprostol<br> | Drug: Misoprostol<br>* Sublingual Misoprostol 200 Micrograms After Spinal Anesthesia<br>* Other names: Brand Name: Cytotec, Cyotec, Serial 022-00 , Code A02BB01;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intraoperative bleeding |  | At the time of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fever |  | During 48 hours after surgery measured every 3 hours | 
| Changing of pulse rate from base |  | Before surgery & intraoperative & 6 hours after surgery | 
| Changing of blood pressure |  | Before surgery & intraoperative & 6 hours after surgery | 
| Diarrhea |  | Before & 6 hours after surgery | 
| Vomiting |  | Before & 6 hours after surgery | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Misoprostol, Oxytocin, Cesarean Delivery, Blood Loss
Controlled Phonation and Vocal Rest Programs After Acute Vocal Exertion in Healthy Adults

Study Overview
=================
Brief Summary
-----------------
The proposed research will investigate the most effective strategy to reduce vocal exertion reported by speakers in noisy environments. Repeated vocal exertion can lead to voice problems and therefore identifying effective strategies can lead to better prevention of acquired voice disorders. This study will compare the effects of vocal rest and controlled phonation both before and after vocal exertion. The investigators hypothesize that vocal rest and controlled phonation will mitigate the negative effects of vocal exertion.

Official Title
-----------------
Vocal Restoration Programs After Acute Vocal Exertion

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Behavioral: Vocal rest and Controlled Phonation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: within age range Exclusion Criteria: Voice Disorders Strong gag reflex Craniofacial disorders Cognitive Impairments Head and Neck Cancer Hearing Difficulties Dentition problems that prevent an oral scope being placed in mouth

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 50 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: Crossover Assignment
Interventional Model Description: Within Subject Design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy Adults<br>Participants will complete vocal rest and controlled phonation | Behavioral: Vocal rest and Controlled Phonation<br>* Voice rest and semi occluded vocal tract voice exercises<br>|
| Experimental: Healthy Adults reporting Vocal Fatigue<br>Participants will complete vocal rest and controlled phonation | Behavioral: Vocal rest and Controlled Phonation<br>* Voice rest and semi occluded vocal tract voice exercises<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Phonation Threshold Pressure | Minimum air pressure required to initiate and sustain vocal fold oscillation | 2.5 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Lung Volume Excursion | The difference between lung volume initiation and termination on connected speech | 2.5 hours |
Ratio of Inferior Vena Cava and Aorta Diameter in Dehydrated Children

Study Overview
=================
Brief Summary
-----------------
There is no definite tool for measurement of dehydration in children Subjective clinical dehydration scale is considered as valuable scoring system, but it cannot be reliable among clinicians sometimes. Some authors found Inferior vena cava/Aorta ratio can be a objective marker for dehydration However, there is no evidence of correlation between clinical dehydration scale and inferior vena cava/aorta ratio We will observe correlation between clinical dehydration scale and inferior vena cava/aorta ratio and change of the ratio according to hydration with intravenous normal saline infusion.

Conditions
-----------------
Dehydration

Intervention / Treatment
-----------------
* Device: Ultrasound
* Drug: normal saline


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children with dehydration who visit emergency department Exclusion Criteria: congenital heart disease bronchopulmonary dysplasia renal disease liver disease

Ages Eligible for Study
-----------------
Minimum Age: 3 Months
Maximum Age: 15 Years

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

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

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 |
| --- | --- |
| Other: Ultrasound, inferior vena cava, aorta, normal saline<br> | Device: Ultrasound<br> <br> Drug: normal saline<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| diameter of inferior vena cava and aorta | we will measure the diameter of inferior vena cava and aorta using ultrasound during every 10 ml/kg infusion of intravenous normal saline | up to 2 hours |
Cardiac Stroke Volume at Rest and During Different Exercise Intensities

Study Overview
=================
Brief Summary
-----------------
The main aim of the present investigation is to study cardiac function in different exercise intensities in healthy human subjects. Two techniques will be used: cardiac ultrasound-derived stroke volume measurements and body impedance measurements. 20 healthy men (n=10) and women (n=10) aged 18-45 years will be investigated at rest and during exercise. All study procedures are non-invasive.

Official Title
-----------------
Cardiac Stroke Volume at Rest and During Different Exercise Intensities

Conditions
-----------------
Cardiac Function

Intervention / Treatment
-----------------
* Behavioral: Acute exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 18-45 BMI 18-30 Resting Blood pressure < 140/90 mmHg Participation in regular exercise Exclusion Criteria: Acute illness Pregnancy Pace maker Artificial joint History of a cardiac event Insulin or medically treated diabetes Any chronic disease or condition that could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results Abundant use of alcohol Use of narcotics Smoking of tobacco or consuming snuff tobacco Diagnosed depressive or bipolar disorder Abnormalities in resting ECG (revised by the study physician)

Ages Eligible for Study
-----------------
Minimum Age: 18 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: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Healthy young men and women<br>Single group consisting of 10 men and 10 women | Behavioral: Acute exercise<br>* Acute exercise with different exercise intensities<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac stroke volume |  | 1 min | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| End-diastolic and end-systolic volumes |  | 1 min | 
| Ejection fraction |  | 1 min |
Adipose Distribution and Atherosclerosis

Study Overview
=================
Brief Summary
-----------------
To relate distribution of adipose tissue measured by a then new imaging technique, Magnetic Resonance Imaging (MRI) to extracranial carotid atherosclerosis, cardiovascular disease risk factors, and to more conventional measures of fat distribution such as body mass index (BMI) and waist/hip ratio. The primary hypothesis was that patients with extracranial carotid atherosclerosis (cases) had more intra-abdominal fat and a higher ratio of intra-abdominal fat to total or subcutaneous fat than age-sex-race matched controls.

Detailed Description
-----------------
BACKGROUND: The study was ancillary to an NIH funded population-based project, the Atherosclerosis Risk in Communities Study (ARIC) that is ongoing in Forsyth County, North Carolina. DESIGN NARRATIVE: Using MRI, the investigators sought to demonstrate strong relationships between intra-abdominal fat and a number of cardiovascular disease risk factors, including history of hypertension, diabetes, cigarette smoking, family history of cardiovascular disease, plasma concentrations of triglyceride, high density lipoprotein (HDL) cholesterol, HDL2 cholesterol, apo A1, Apo B, postprandial lipid response to a fat rich meal, glucose, insulin, sex hormone binding globulin, and total and free testosterone. Certain other risk factors were less certain to show a relation to intra-abdominal fat as measured by MRI, including various hemostatic factors, as well as certain dietary factors such as consumption of alcohol, dietary fat, and cholesterol, but this research afforded an opportunity to explore these relationships. Finally, the investigators proposed to relate intra-abdominal fat to more conventional measures of fat distribution (waist/hip ratio, subscapular skinfold thickness, etc.) in an attempt to identify strong correlates of intra-abdominal fat that could be more easily measured. The study completion date listed in this record was obtained from the End Date entered in the Protocol Registration and Results System (PRS) recor

Conditions
-----------------
Cardiovascular Diseases, Heart Diseases, Carotid Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
No eligibility criteria

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

Sexes Eligible for Study
-----------------
Male

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 |
| --- | --- | --- |