linjc16/ctgov huggingface dataset:
Ferritin Screening And IRon Treatment for Maternal Anemia and FGR Prevention Trial

Study Overview
=================
Brief Summary
-----------------
Prevalence of anemia in Asia is more than 50%. All woman who book for antenatal care with non-anaemic iron deficiency (NAID) can be offered therapeutic doses of parentral iron, as a directly observed complete therapy, to prevent of maternal anaemia and fetal growth restriction. The investigators will compare this intervention with usual care in a multicentre randomised trial.

Detailed Description
-----------------
Prevalence of anemia (haemoglobin less than 11 gm/dl) in Asia is more than 50% and non-anaemic iron deficiency (ferritin less than 30 microgm/l) or NAID is likely to be more prevalent than this figure. It has been hypothesised that NAID in pregnancy can be linked to maternal fatigue and anaemia, and infant birth weight and growth restriction. The investigators will compare, in NAID, active intervention (therapeutic doses of parentral iron, as a directly observed complete therapy, to replenish iron stores) vs usual care (prophylactic oral iron supplementation) to prevent of maternal anaemia and fetal growth restriction in a multicentre randomised trial.

Official Title
-----------------
Ferritin Screening And IRon Treatment for Maternal Anemia and Fetal Growth Restriction (FGR) Prevention - a Multi Centre Randomised Controlled Trial (RCT)

Conditions
-----------------
Iron Deficiency (Without Anemia), Pregnancy Related

Intervention / Treatment
-----------------
* Drug: Parentral Iron


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Non-anaemic iron deficiency Exclusion Criteria: Anaemia or normal iron stores

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 45 Years

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

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

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

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Multi centre randomised trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Treatment<br>Intravenous Iron to correct Iron deficiency without anaemia | Drug: Parentral Iron<br>* Correction of Iron stores without anaemia<br>|
| No Intervention: Prophylaxis<br>Usual antenatal care | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal anaemia | Haemoglobin concentration (g/dl) | 36 weeks' gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fetal growth restriction | Birthweight for gestational age (percentile) | At birth | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
anemia, ferritin
A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3

Study Overview
=================
Brief Summary
-----------------
Our project will assess the feasibility and estimate preliminary efficacy of a multilevel intervention to improve HPV vaccine series initiation among adolescents in Medicaid and CHIP. The investigators will use two intervention components: postcards and an iPad survey system. To estimate efficacy the investigators will select potential participants from Florida Medicaid and CHIP. The investigators will assess their claims for the HPV vaccine before and after the intervention.

Official Title
-----------------
A Multilevel Approach to Increasing HPV Vaccine Initiation Among Adolescents - Part 3

Conditions
-----------------
Human Papilloma Virus

Intervention / Treatment
-----------------
* Other: postcard campaign
* Other: Health Information Technology system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Enrolled in Florida Medicaid Not initiated the HPV vaccine series at the start of the study period. Exclusion Criteria: Anyone who has a severe (life threatening) allergy to any component of HPV vaccine, esp yeast Pregnant Not enrolled in Florida Medicaid

Ages Eligible for Study
-----------------
Minimum Age: 11 Years
Maximum 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: Health Services Research
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Postcard campaign<br> | Other: postcard campaign<br>* Post card sent to parent only<br>|
| Active Comparator: Provider-only intervention<br> | Other: Health Information Technology system<br>* Accessed by adolescent and provider only<br>|
| Active Comparator: Patient and provider intervention<br> | Other: postcard campaign<br>* Post card sent to parent only<br>Other: Health Information Technology system<br>* Accessed by adolescent and provider only<br>|
| No Intervention: Standard care<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of participants receiving HPV vaccine | The percent age eligible participants who initiate HPV vaccination. | Up to 5 months | 
| Number of preventive care visits | The percent age eligible participants received a preventive care visit | Up to 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
preventative, postcard, vaccinate
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study

Study Overview
=================
Brief Summary
-----------------
A randomised open-label pilot study to assess the safety and efficacy of treatment with a drug eluting balloon alone in coronary de novo lesions). Elective patients requiring PCI to coronary de novo lesions in vessels 2.5 mm - 4.0 mm.

Official Title
-----------------
The Treatment of Coronary De-novo Lesions With the Elutax Paclitaxel-eluting Balloon Alone, a Pilot Study

Conditions
-----------------
Stable Angina, Coronary Stenosis

Intervention / Treatment
-----------------
* Device: drug eluting balloon
* Device: drug eluting stent


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient ≥ 18years old Stable angina symptoms Elective treatment to coronary lesion Reference vessel diameters of ≥ 2.5mm and ≤ 4.0 mm on visual inspection Exclusion Criteria: Left main stem lesion Bifurcation lesions Acute coronary syndrome (UAP, NSTEMI, STEMI) Cardiogenic shock Chronic total occlusion Additional lesions requiring PCI Platelet count ≤ 50 x 109/mm3 Left ventricular ejection fraction ≤ 30% Patient life expectancy less than 12 months Known allergies to aspirin, clopidogrel, prasugrel, heparin, stainless steel, intravenous contrast (severe), or paclitaxel Participation in another investigational drug or device study Patient unable to give 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?
-----------------

Design Details

Primary Purpose: Treatment


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Stent<br>drug eluting stent (Resolute) | Device: drug eluting stent<br> <br> |
| Experimental: drug eluting balloon<br>drug eluting balloon (Elutax) | Device: drug eluting balloon<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Major adverse cardiac events |  | 3 months |
FORE-SIGHT Tissue Oximeter During Cardiac Surgery

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to measure cerebral and lower extremity oximetry on patients during cardiac surgery.

Detailed Description
-----------------
The purpose of this research study is to collect data from a tissue oximeter device that measures brain oxygen saturation simultaneous with data from the same device that monitors skeletal muscle during cardiac surgery. This monitoring will allow for continuous, non-invasive, and earlier assessment of perfusion abnormalities/hypoperfusion. Two sensors from the FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows and two additional sensors will be placed on the leg muscles. Data from the FORE-SIGHT Elite monitor will be recorded in addition to clinical and demographic data, which is standard of care during the procedure, for research purposes to look at factors associated with desaturations.

Official Title
-----------------
CAS Medical Systems FORE-SIGHT Elite Tissue Oximeter During Cardiac Surgery

Conditions
-----------------
Cardiac Surgical Patients

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects where cerebral oximetry is monitored during their surgery Exclusion Criteria: Birthmarks, tattoos, or other skin abnormalities that FORE-SIGHT Sensors cannot avoid

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 |
| --- | --- | --- |
| Cerebral Oxygen Saturation | Two sensors from FORE-SIGHT Elite monitor will be placed on the forehead above the eyebrows to continuously monitor cerebral oxygen saturation. | Duration of the surgery ( 5-7 hours) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Non-Cerebral Oxygen Saturation | Two sensors from FORE-SIGHT Elite monitor will be placed on the leg muscles to continuously monitor non-cerebral/skeletal muscle oxygen saturation. | Duration of the surgery ( 5-7 hours) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
cardiac surgery, cerebral oximetry, lower extremity oximetry
Examination of Virtual Supermarket (Vmall) as an Assessment of Executive Functions in Children and Adolescents With Acquired Brain Injury

Study Overview
=================
Brief Summary
-----------------
The purpose of this research is to find whether or not there are differences in the executive functions during shopping in a virtual mall, between children with Acquired Brain Injury (ABI) vs healthy children. The hypothesis is that there will be differences in time (more time to shop) and mistakes (more mistakes during shopping), in the ABI group.

Conditions
-----------------
Brain Injuries

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: children with ABI at least a year after injury who have been discharged from hospital and back home Exclusion Criteria: children with learning disabilities former to injury visual disabilities or developmental disabilities

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 16 Years

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

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

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
year and more after TBI, good vision, at least one functinal hand, cap[able od doing shopping during everyday life
Validation BITSS Brussels Infant Stool Scale

Study Overview
=================
Brief Summary
-----------------
validation of stool scale in toddlers

Detailed Description
-----------------
objective : the Bristol stool form scale (BSFS) is inadequate for non-toilet trained children. The Brussels Infant and Toddler Stool Scale (BITTS) was developed, consisting of 7 photograps of diapers containing stools of infants and toddlers. We aimed to evaluate inter-observer reliability of stool consistency assessment among parents, nurses and medical doctors using the BITTS. Method : In this multicenter cross-sectional study (2016-2017), Bitts photograps were rated according to the BSFS. The reliability of the BITTS was evaluated using the overall proportion of perfect agreement and the linearly weighted K statistic. What is known : reliable assessment of stool consistency is important for evaluating children's defecation pattern and diagnosing gastrointestinal disorders. the reliability of the Bristol Stool Form Scale, developed for adults, has been debated for young children who are non-toilet trained and wear diapers To get validation of the BITTS : a non-toilet trained child makes stool in diaper caregiver scores the aspect of the stool according to the BITTS caregiver takes a picture of the diaper after 1 monts she rescores the picture according to the BITTS

Official Title
-----------------
Validation BITSS Brussels Infant Stool Scale

Conditions
-----------------
Validation of BITTS

Intervention / Treatment
-----------------
* Other: validation of Bitts


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria:pictures of diapers with stool of all childeren who are non-toilet trained - Exclusion Criteria: none

Ages Eligible for Study
-----------------
Minimum Age: 0 Years
Maximum Age: 5 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Other: validation of Bitts|No intervention, observation of photographs of stool|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| to evaluate the inter-observer reliability of stool consistency | stool of a non-toilet trained child wuk be scired by a caregiver according to the BITTS. Then the caregiver takes a picter of this diaper with stool. After 1 month she rescores the picter according to BITTS | 6months |
Effect of Traditional Chinese Medicine on GI Function Recovery and Nutrition Support in SAP

Study Overview
=================
Brief Summary
-----------------
With multicenter randomized control clinical evaluation investigations, the effect of traditional Chinese medicine on gastrointestinal function recovery and nutrition support in early stage of severe acute pancreatitis (SAP) was evaluated, and the therapeutic effects, safety and indications assured. Drawing in latest research fruits at home and abroad, a clinical practical guideline would be formed, to be popularized all over China.

Official Title
-----------------
Effect of Traditional Chinese Medicine on Gastrointestinal Function Recovery and Nutrition Support in Severe Acute Pancreatitis

Conditions
-----------------
Pancreatitis, Acute Necrotizing

Intervention / Treatment
-----------------
* Drug: Qingyi granules


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Adult patients 18 yr-70 yr Complying with the diagnostic standard of acute pancretitis (clinical symptoms and signs, elevated blood and urine amylase, and imaging criteria) Conforming to 3 or more Ranson's criteria and APACHE-II score larger than 8, Balhazar CT score larger than 5 Exclusion Criteria: Pregnancy Nursing mother Critical cases of advanced tumor On the verge of death (estimated to be moral in 12h) Severe visceral function disturbance Patients undergoing other therapeutic research that might interfere with the present study

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 70 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: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Qingyi granules|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | endpoint of the trial | 
| Morbidity |  | endpoint of the trial | 
| Hospitalization days |  | endpoint of the trial | 
| Total expenses |  | endpoint of the trial | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| G-I tract function: nature of abdominal pain, intra-abdominal pressure, number of bowel movements |  | The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge | 
| Parameters of nutrition |  | The above criteria should be tested on admission, and 24h, 48h and 72h later, 5d, 7d, and 2wks after admission, and on the day of discharge |
Respiration Rate Monitoring During Transitions

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the performance of the software that calculates respiration rate for the study pulse oximetry monitoring system during transitions of ventilation type from spontaneous breathing to controlled ventilation.

Official Title
-----------------
Assessment of Respiration Rate Monitoring During Transitions From Spontaneous to Controlled Ventilation

Conditions
-----------------
Focus of the Study is Measuring Respiratory Rate

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be undergoing a procedure with planned general anesthesia involving placement of an endotracheal tube or laryngeal mask airway following induction of anesthesia. American Society of Anesthesiologists physical status classification (ASA) Status 1, 2 or 3. Body mass index (BMI) ≤30 kg/m2. Subject is willing and able to provide written consent. Exclusion Criteria: Female subjects of child-bearing potential with a positive pregnancy test or an absence of documented non-childbearing status in the medical history records. Female subjects who are currently lactating and breastfeeding. Subjects with any evidence of potential difficulty in mask ventilation and/or tracheal intubation. Subject has an abnormality that may prevent proper application of the device/sensors. Subject is in atrial fibrillation. Subject has a documented history of frequent premature ventricular contractions (PVCs), defined as greater than 3 in 30 seconds or greater than 6 in 60 seconds. Subject has an implanted pacemaker. Subjects with non-sinus rhythm, frequent premature ventricular complexes (> 5 min), or abnormal PR, QRS, or QT intervals on screening ECG. Subjects with artificial finger nails.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No treatment<br>No treatment, prospective observational | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to report a Respiration Rate value after initiation of controlled ventilation | Time (in seconds) for the software to report a Respiration Rate value within one breath per minute of the controlled ventilation rate after placement of the airway device (endotracheal tube or laryngeal mask airway) | 1 - 3 minutes after the initiation of controlled ventilation |
TVMR With the Innovalve System Trial - TWIST-BE TWIST-PILOT-BE

Study Overview
=================
Brief Summary
-----------------
Study to evaluate the safety and performance of the Innovalve mitral valve replacement system

Official Title
-----------------
TVMR With the Innovalve System Trial - Pilot Study in Belgium

Conditions
-----------------
Mitral Valve Regurgitation (Degenerative or Functional)

Intervention / Treatment
-----------------
* Device: Innovalve TMVR system


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Clinically significant, symptomatic mitral regurgitation High risk for open-heart surgery Meets anatomical criteria Exclusion Criteria: Unsuitable anatomy Patient is inoperable EF <30%

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: MV replacement with Innovalve TMVR system<br>MV replacement with Innovalve TMVR system | Device: Innovalve TMVR system<br>* Innovalve TMVR system<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients with implant or delivery related serious adverse events at 30 days | Number of patients with implant or delivery related serious adverse events at 30 days | 30 days |