linjc16/ctgov huggingface dataset:
PLAC1 in Reproduction

Study Overview
=================
Brief Summary
-----------------
The PLAC1 gene is a recently described X-linked gene that maps to a region of the X chromosome thought to be important for normal fetal and placental development. Elevated levels of PLAC1 mRNA were detected in preeclampsia and appeared to be directly related to disease severity. PLAC1 may serve as a useful marker of placental dysfunction or threatened pregnancy. The objective of this study is to measure the prevalence of circulating anti-PLAC1 antibodies in pregnant maternal serum and correlate it with pregnancy outcome. It is likely that women with these antibodies are at higher risk for adverse pregnancy outcomes. Approximately 5% (50 of 1000) will be expected to have anti-PLAC1 antibodies based on previously reported data. The prevalence of these antibodies and their clinical impact on pregnancy outcomes will be determined. 1000 healthy, multiparous and primigravid women will be screened for anti-PLAC1 antibodies at their routine prenatal clinic visits. Subjects will be enrolled at their first clinic visit at USF Health, South Tampa Center, Department of Obstetrics. Blood (1.0 ml) will be obtained as part of the routine blood draw at the time of enrollment. Blood will only be collected when drawn as part of routine laboratory testing as determined by the primary care provider. Additional blood samples (1.0 ml) will be collected throughout pregnancy at the same time blood is obtained for routine or otherwise clinically indicated laboratory testing. A maximum of 5 samples will be collected through the pregnancy. Maternal demographic data will be collected and patients will be followed longitudinally to the completion of pregnancy to ascertain their clinical status during pregnancy, onset of premature labor, premature rupture of membranes, delivery date, and gestational age at delivery.

Official Title
-----------------
PLAC1 in Reproduction

Conditions
-----------------
Pregnancy

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Pregnant, primigravid and multigravid women between the ages of 14 and 55, receiving prenatal care at USF Health, STC, Dept. of Obstetrics. Exclusion Criteria: presence of significant cardiac disease renal disease chronic hypertension chromosomal abnormalities cancer

Ages Eligible for Study
-----------------
Minimum Age: 14 Years
Maximum Age: 55 Years

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

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

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Anti-PLAC1 autoantibodies |  | During pregnancy | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
PLAC1, pregnant, first prenatal visit, pre-eclampsia
Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System

Study Overview
=================
Brief Summary
-----------------
The aim of this prospective, randomized study is to compare the performance, safety, and ease of use (usability) between two closed suction systems, the AirWay Medix Closed Suction System and Kimberly KimVent while intubated with an endotracheal in hospitals and ICU. 26 adults with an endotracheal tube and mechanical ventilation will be randomized into 2 groups to receive one of the following closed suction systems endotracheal tubes: AirWay Medix Closed Suction System KimVent Turbo-Cleaning Closed Suction System Kimberly clarK The groups will be compared regarding the safety, performance and ease of use (usability).

Official Title
-----------------
Performance Evaluation of AirWay Medix Closed Suction System Compared With a Standard Closed Suction System

Conditions
-----------------
Endotracheal Tube, Mechanical Ventilation

Intervention / Treatment
-----------------
* Device: AirWay Medix Closed Suction System


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged greater than 18 years Mechanically ventilated for more than 6 hours Endotracheal intubation anticipated to be routine (not difficult) based upon preoperative airway assessment Signed informed consent Sexually active female subjects of childbearing potential must be practicing adequate contraception during the treatment period - Exclusion Criteria: Gross / massive hemoptysis Received lung transplantation in the past Admitted from other hospital already mechanically ventilated Previously received mechanical ventilation Active bronchial bleeding Pregnant women, women who plan to become pregnant and breastfeeding women. Substance or alcohol abuse Participation in concurrent trials Any reasons making the patient a poor candidate in the opinion of the investigator -

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: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: KimVent Turbo-Cleaning Closed Suction System Kimberly clark<br> | Device: AirWay Medix Closed Suction System<br>* AirWay Medix Closed Suction System<br>|
| Active Comparator: Airway Medix Closed Suction System<br> | Device: AirWay Medix Closed Suction System<br>* AirWay Medix Closed Suction System<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| hemodynamic and respiratory data |  | Patients will be followed until extubation | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
hemodynamics, respiratory
Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care

Study Overview
=================
Brief Summary
-----------------
This is an observational study exploring the levels of mobility and rehabilitation in patients admitted to critical care with a confirmed diagnosis of COVID-19

Detailed Description
-----------------
An admission to an intensive care unit (ICU) often results in significant muscle weakness and physical deconditioning, which can take many months or even years for recovery. Early and progressive programmes of rehabilitation are recommended to limit any muscle loss and support recovery as early as possible. Patients admitted to intensive care with COVID-19 have been found to require prolonged periods of mechanical ventilation, high sedation and neuromuscular blocking use and as a result require prolonged stays in the ICU. As yet no data exists to examine the specific physical impact this may have, or whether it is safe and feasible to commence this earlier rehabilitation within the ICU for patients with a diagnosis of COVID-19. Our study set out to evaluate the levels of rehabilitation which were delivered in a large acute NHS trust.

Official Title
-----------------
Physical Activity Levels in COVID-19 Patients Admitted to Intensive Care Requiring Invasive Ventilation: An Observational Study

Conditions
-----------------
COVID-19, Critical Illness, Ards, ICU Acquired Weakness

Intervention / Treatment
-----------------
* Other: Physiotherapy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: having a confirmed diagnosis of COVID-19 being mechanically ventilated for at least 24 hours surviving to critical care discharge. 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?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| COVID-19<br>Observations taken of standard physiotherapy practice. All patients are assessed daily and receive respiratory care and rehabilitation as deemed appropriate by the treating therapist | Other: Physiotherapy<br>* Daily physiotherapy to include respiratory care and rehabilitation based on the individual therapists clinical reasoning<br>* Other names: Rehabilitation;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mobility level | Highest level of mobility achieved at the point of ICU discharge | At ICU discharge, an average of 3 weeks | 
| Time taken to first mobilise | Time taken to first mobilise, defined as sitting on the edge of the bed or higher | during ICU admission, up to 3 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Discharge location | Discharged to home, home with rehab, or a community rehab facility | Hospital discharge, up to 2 months |
The GentleWave Registry

Study Overview
=================
Brief Summary
-----------------
The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage. The registry population includes up to 500 subjects that have been treated with the Sonendo GentleWave System at up to 25 clinical sites in the United States.

Detailed Description
-----------------
The purpose of this registry is to gain a real world perspective for the use and outcomes associated with the Sonendo® GentleWave System usage. Up to 25 clinical sites in the United States. Up to 500 subjects that have been treated with the Sonendo GentleWave System. To assess outcomes for teeth treated with the GentleWave System in a commercial setting.

Official Title
-----------------
The GentleWave Post-Market Registry

Conditions
-----------------
Root Canal

Intervention / Treatment
-----------------
* Device: GentleWave System Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: One or more teeth treated with the Sonendo GentleWave System Exclusion Criteria: Institutionalized patients or prisoners
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Patients that were treated with the GentleWave System<br> | Device: GentleWave System Treatment<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Healing | Radiographic analysis and clinical signs and symptoms at 24 months | 24 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Retreatment Rates | Rate of retreatment at 24 months | 24 months |
Airtraq Versus Conventional Laryngoscopy in Children

Study Overview
=================
Brief Summary
-----------------
The investigators aim to compare the new paediatric Airtraq indirect optical laryngoscope with conventional direct laryngoscopy for tracheal intubation in a randomised crossover study during routine anaesthesia. The investigators hypothesise that the Airtraq is as good as conventional laryngoscopy for tracheal intubation of infants and children. This will be an equivalence rather than a non-inferiority study.

Official Title
-----------------
Randomised Controlled Trial of the Airtraq Optical Laryngoscope and Conventional Laryngoscopy in Children

Conditions
-----------------
Children, General Anesthesia, Intubation

Intervention / Treatment
-----------------
* Device: Airtraq laryngoscopy


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All children less than 6 years of age, in whom a size 2.5 - 5.5 tracheal tube would be considered suitable. Classified by the American Society of Anesthesiology (ASA) as grade 1-3. Scheduled for surgery under general anaesthesia, and in whom tracheal intubation and neuromuscular blocking drugs are planned to be used. Exclusion Criteria: inability of patient or parents to understand the study or consent process known or suspected difficult airway ASA 4 and above

Ages Eligible for Study
-----------------
Maximum Age: 6 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Conventional<br>conventional laryngoscopy for intubation | |
| Experimental: Airtraq<br>laryngoscopy with Airtraq for intubation | Device: Airtraq laryngoscopy<br>* laryngoscopy and intubation<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| time taken to successful intubation | The primary outcome measure will be time taken to successful intubation. This will be recorded by a second operator using a handheld stopwatch or wall clock with second hand. Time will commence when the intubation device is handed to the anaesthetist, and stopped after the first successful inflation of the lungs (first upstroke of capnography trace). | 30 mins | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grade of laryngoscopy |  | 30 mins | 
| POGO score |  | 30 mins | 
| VAS ease of intubation |  | 30 mins | 
| evidence of traumatic intubation |  | 24 hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
children, intubation, laryngoscope
Hemodynamic Response During Goal Directed Fluid Therapy in the OR

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to retrospectively evaluate the hemodynamic response to goal directed fluid therapy fluid during open abdominal surgery where goal directed fluid therapy is a standard of care after establishing a pre-incision baseline response to fluids.

Detailed Description
-----------------
Electronic and annotated observation data to support an algorithm library

Official Title
-----------------
Correlation of Multiple Invasive and Non-Invasive Hemodynamic Monitored Modalities to Support Goal Directed Fluid Therapy During Open Abdominal Surgery

Conditions
-----------------
Hemodynamic Instability

Intervention / Treatment
-----------------
* Procedure: Initial bolus pre-incision


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adults ≥18 years booked for an open abdominal procedure American Society of Anaesthesiologists (ASA) Physical Status 1 - 3 Expected duration of surgical procedure to be ≥ 2 hours Standard of care monitoring to include cardiac output Exclusion Criteria: Open chest surgical procedure expected Cardiac arrhythmia such as atrial fibrillation. Right Ventricular Failure Aortic regurgitation

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Initial bolus pre-incision<br>Initial pre-incision bolus of 500 cc of fluids with hemodynamic response recorded | Procedure: Initial bolus pre-incision<br>* Measured hemodynamic response to pre-incision bolus<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Dynamic Hemodynamic Response to Fluid Resuscitation | Physiological parameters compared before and after fluid bolus for fluid resuscitation. | Up to 6 hours but not to exceed duration of surgical procedure | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Open Abdominal Surgical Procedure
A Phase I, Single IV Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is determine whether a single IV dose of PF-04360365 is safe and well tolerated in Adults with Mild to Moderate Alzheimer's disease.

Official Title
-----------------
A Phase I, Randomized, Placebo Controlled, Double Blind Dose Escalation Study Of The Safety, Tolerability, Pharmacokinetics,Pharmacodynamics, And Immunogenicity Of A Single Intravenous Dose Of PF-04360365 In Adults With Mild To Moderate Alzheimer's Disease

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

Intervention / Treatment
-----------------
* Biological: PF-04360365
* Drug: Placebo


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or Females of non-childbearing potential, age 50-85 Diagnosis of probable Alzheimer's disease, consistent with criteria from both: 1) National Institute of Neurological and Communicable Disease and Stroke and Alzheimer's Disease and Related Disorders Association (NINCDS-ADRDA); and 2)Diagnostic and Statistical Manual of Mental Disorders (DSM IV) Mini-mental status exam score of 16-26 inclusive Rosen-Modified Hachinski Ischemia Score < or = 4 Exclusion Criteria: Diagnosis or history of other dementia or neurodegenerative disorders Diagnosis or history of clinically significant cerebrovascular disease Specific findings on magnetic resonance imaging (MRI): cortical infarct, micro hemorrhage, multiple white matter lacunes, extensive white matter abnormalities History of autoimmune disorders History of allergic or anaphylactic reactions

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active treatment<br>5 possible active doses | Biological: PF-04360365<br>* Monoclonal antibody<br>|
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To examine the safety, tolerability, and pharmacokinetics of a single dose of PF-04360365 in subjects with mild to moderate AD for one year following dosing. |  | 366 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To characterize the pharmacokinetic, pharmacodynamic and immunogenicity profile of PF-04360365 for one year following dosing. |  | 366 days |
Comparison of Two Biological Aortic Valves. Mosaic Ultra and Trifecta.

Study Overview
=================
Brief Summary
-----------------
Comparing two biological valves in a prospective randomized study. Mosaic Ultra and Trifecta. The investigators are looking at EOA and the Pressure Gradients over the valve by patients with the same annulus measured by a hegar dilatator.

Conditions
-----------------
Aortic Valve Stenosis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aortic valve disease Exclusion Criteria: Pregnant Breast feeding Aortic valve bigger than 23 mm Endocarditis EF < 50%

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 |
| --- | --- |
| Trifecta<br>Degenerated aortic valve with indication for aortic valve replacement | |
| mosaic Ultra<br>Need a aortic valve replacement | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pressure gradients | Investigators want too look at the effient opening area and pressure gradients of the two valves we are implanting on patients with the same size of the annulus. | 240 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
EOA
TheEffect of pH on Misoprostol in Induction of Labor

Study Overview
=================
Brief Summary
-----------------
Misoprostol is a synthetic analogue of the naturally occurring prostaglandin E1. It was initially marketed for the treatment of peptic ulcers due to its mucosal protective and anti-secretory properties, but has commonly been used for the induction of abortion and labour .

Detailed Description
-----------------
Although initially having been established for oral use, misoprostol tablets are commonly used as vaginal suppositories for the previously purposes. Water or saline are frequently used in common practice to moisten the tablets prior to their administration, however, according to the pharmacokinetics of the drug, it should liquefy better in an acidic medium

Official Title
-----------------
TheEffect of pH on Misoprostol in Induction of Labor in Full Term Pregnancies

Conditions
-----------------
Labor Pain

Intervention / Treatment
-----------------
* Drug: misoprostol in a neutral media
* Drug: misoprostol in an acidic media
* Drug: misoprostol in an alkaline media


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Singleton pregnancies. Gestational age 38-41 weeks. Cephalic presentation Exclusion Criteria: 1. Multi-fetal pregnancy. 2. Pregnant women less than 38 weeks gestation.

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 42 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 3 paralle groups
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: misoprostol in neutral media<br>Intervention : misoprostol in a neutral media will be given to women to induce labour | Drug: misoprostol in a neutral media<br>* giving misoprostol in a neutral media<br>* Other names: Drug (misoprostol + neutral media );|
| Active Comparator: Misoprostol in acidic media<br>Intervention : misoprostol in acidic media will be given to induce labour | Drug: misoprostol in an acidic media<br>* giving misoprostol in an acidic media<br>* Other names: Drug ( Misoprostol + acidic media );|
| Sham Comparator: Misoprostol in alkaline media<br>Intervention : misoprostol in alkaline media will be given to induce labour | Drug: misoprostol in an alkaline media<br>* giving misoprostol in an alkaline media<br>* Other names: Drug ( misoprostol + alkaline media );|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of women who will start lactive phase of labour after treatment | the number of women in a group who will enter in active labour faster than other groups | within 24 hours |