linjc16/ctgov huggingface dataset:
Mechanisms for Covid-19 Disease Complications

Study Overview
=================
Brief Summary
-----------------
Covid-19 is associated with a wide range of symptoms and clinical trajectories, and early identification of patients at risk for developing severe disease is desirable. Several risk markers and comorbidity profiles have been proposed but their relative importance in unselected patients admitted to hospital with Covid-19 remains unclear. This study aims to assess the prognostic value organ specific biomarkers, viral dynamics and immune response markers in patients infected with SARS-CoV2.

Official Title
-----------------
Changes in Organ Specific Biomarkers, Virus Expression and Prognosis of Covid-19

Conditions
-----------------
COVID, Coronavirus Infection

Participation Criteria
=================
Eligibility Criteria
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Inclusion Criteria: All patients >18 years of age with a positive test for SARS-CoV2 are eligble for inclusion. Healty age-matched volunteers will be included as a control group Exclusion Criteria: None

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with ICU admission or death | Combined outcome measure of either ICU admission or death | From hospital admission (baseline) until the date of either admission to the ICU or death during the index hospitalization (up to 52 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with ICU admission | ICU admission | From hospital admission (baseline) until the date of admission to the ICU during the index hospitalization (up to 52 weeks) | 
| Number of participants with death from all causes | Hospital mortality | From hospital admission (baseline) unitl the date of death during the index hospitalization (up to 52 weeks) | 
| Total duration of ICU stay | Total time admitted to the ICU | From admission to the ICU until transfer to another ward, discharge from the hospital or death during the index hospitalization (up to 52 weeks) | 
| Total duration of hospital stay |  | From hospital admission (baseline) until hospital discharge or death during the index hospitalization (up to 52 weeks) | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
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Covid-19, Biomarkers, Cardiovascular disease, Prognosis
Automated Left Ventricular Function Evaluation by LVivoEF

Study Overview
=================
Brief Summary
-----------------
Left ventricular ejection fraction (EF) is evaluated in every echocardiographic examination either by visual estimation (eyeballing) requiring high level of training and expertise and/or by manual tracing of the endocard from which EF is calculated (manual biplane method (MBP)). This procedure is subjective and time consuming. The objective of this study is to compare the performance of LVivoEF software system to the measurements obtained by the routinely used methods.

Detailed Description
-----------------
LVivoEF is a decision support system (software) for automated global left ventricle (LV) systolic function evaluation from echocardiographic examinations. LVivoEF technology is based on a novel image processing algorithm for LV edge detection and ejection fraction (EF) evaluation. LVivoEF provides fully automated measurements of the left ventricle (LV) from two apical views the four chamber (4CH) and the two chamber (2CH).

Official Title
-----------------
Automated Left Ventricular Function Evaluation by LVivoEF

Conditions
-----------------
EF Evaluation From 4 Chamber Plane, EF Evaluation From 2 Chamber Plane, Biplane EF Evaluation, Left Ventricular Function

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age > 18 Patients referred to an echocardiographic examination. The patients will be consecutive until 30% of patients with normal LV function are enrolled. After that only consecutive patients with abnormal LV function will be included. Exclusion Criteria: Examinations in which more than one third of the endocard is not visible in a plane (2CH/4CH) Patients with Left bundle branch block (LBBB)

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?
-----------------
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
-----------------
EF, EDV, ESV, Biplane, Echocardiography
Clinician Managed Interpersonal Psychotherapy

Study Overview
=================
Brief Summary
-----------------
This 12-week study will evaluate the effectiveness of Clinician-Managed Interpersonal Psychotherapy (CM-IPT) in treating postpartum depression and will compare CM-IPT to standard IPT.

Detailed Description
-----------------
CM-IPT is delivered in 12 sessions over the course of a year. Standard IPT is delivered in 12 sessions in the first 12 weeks after treatment assignment.

Official Title
-----------------
Clinician Managed Interpersonal Psychotherapy

Conditions
-----------------
Depression, Depression, Postpartum

Intervention / Treatment
-----------------
* Behavioral: Standard interpersonal psychotherapy (IPT)
* Behavioral: Clinician managed interpersonal psychotherapy (CM-IPT)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Women between 8 and 24 weeks postpartum Meet DSM-IV criteria for Major Depression Hamilton Rating Scale for Depression score of 12 or more Exclusion criteria: Active substance abuse Psychotic disorders

Ages Eligible for Study
-----------------
Minimum Age: 18 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Participants will receive clinician-managed interpersonal psychotherapy | Behavioral: Clinician managed interpersonal psychotherapy (CM-IPT)<br>* Participants will receive 12 sessions of CM-IPT over 1 year.<br>|
| Active Comparator: 2<br>Participants will receive standard interpersonal psychotherapy | Behavioral: Standard interpersonal psychotherapy (IPT)<br>* Participants will receive 12 sessions of IPT over 12 weeks.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hamilton Rating Scale for Depression |  | Measured at Week 12 |
Sources of Bacterial Contamination in Human Milk Samples From the MiLC Trial

Study Overview
=================
Brief Summary
-----------------
This observational study is a sub-study of the MiLC Trial (ClinicalTrials.gov Identifier: NCT03123874). Our objective is to characterize the bacterial communities of women's breasts, hands, their pump and milk collection kit, and their babies' mouths among the participants of the MiLC Trial. As part of the original protocol, we collected swabs of each of these areas from each dyad before women pumped with their own pumps. By characterizing these communities, we can identify from where the bacteria in human milk (HM) originates, and determine whether pumping with mother's own pumps enriches the bacterial communities of HM compared to pumping with a sterile pump.

Official Title
-----------------
Sources of Bacterial Contamination in Human Milk Samples From the Milk in Life Conditions (MiLC) Trial

Conditions
-----------------
Bacterial Communities

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Mother-infant dyads who participated in the MiLC Trial. Exclusion Criteria: Anyone who did not participate in the MiLC Trial.

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

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| MiLC Cohort<br>Participants donated HM from two consecutive pumping sessions at home. Women pumped once with their own pump and milk collection kit, and once with a sterile and sterile collection kit. Both pumping sessions occurred at participants' homes between 0700 and 1100 hours. The second pumping session occurred within 3 hr (+/- 30 min) after the beginning of the first. Randomization was used to determine which pump was used first. Women elected from which breast they donated their HM and were asked not to nurse on that side 2 hr before the first pumping session and not until after the second. Before women pumped with their own pump, swabs were taken of the breast from which HM was donated, the women's dominant hand, their own bottle/flange, their own pumps (port of pump and tubing), and their babies' mouths. There was only one group but stratified enrollment was used to ensure equal numbers of women whose infants consumed HM only and women whose infants consumed HM and complementary foods. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bacterial communities | Bacterial communities of each swab (breast, hand, mother's own bottle/flange, mother's own pump/tubing, and infant mouth) will be determined by next-generation sequencing of the V1-V3 region of the 16S rRNA bacterial gene. | 0 days after pumping | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Microbiota, Microbiome
Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4

Study Overview
=================
Brief Summary
-----------------
This is a multicenter post-marketing clinical follow-up study to collect safety and performance data in a prospective cohort of patients who will have undergone coil embolization using the ED Coil and ED Detach Generator v4.

Official Title
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Post Market Clinical Follow-Up for ED Coil / Electro-detach Generator v4

Conditions
-----------------
Aneurysm, Arteriovenous Malformations, Arterio-venous Fistula

Intervention / Treatment
-----------------
* Device: ED Coil / Electro-detach Generator v4


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients are over 18 years of age. Patients will undergo catheter embolization using the Kaneka ED Coil with the ED Detach Generator v4 for aneurysm, arteriovenous malformation (AVM), or arteriovenous fistula (AFV) The patient, or his/her representative, has agreed to the informed consent. Exclusion Criteria: The patient, or his/her representative, is unwilling or unable to agree to the 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?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: ED Coil / Electro-detach Generator v4|The ED Coil is used for vascular embolization with a platinum coil at the target lesion in a patient's blood vessel. The ED Detach Generator is intended to for use solely to detach the platinum coil from the delivery catheter of the ED Coil.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Performance Measure | The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion | At 6 months | 
| Performance Measure | The recanalization in aneurysms will be classified using the Raymond-Roy Classification. The outcomes following embolization of arteriovenous malformations and arteriovenous fistula will be classified as follows complete occlusion/subtotal occlusion/ partial occlusion | At 12 months | 
| Safety Measure - Assessment of Adverse Events | All adverse events will be recorded, along with their seriousness and relatedness to the device or the procedure. | During 12 months | 
| Technical Measure | The technical properties of the ED Electrodetach Generator v4 will be assessed by successful coil detachment (yes/no) | At embolization procedure, an average of 1 week | 
| Technical Measure | The technical properties of the ED Electrodetach Generator v4 will be assessed by the the number of detachment attempts | At embolization procedure, an average of 1 week |
Does Splinting Prevent Contractures Following Stroke?

Study Overview
=================
Brief Summary
-----------------
After a stroke, many people develop contracture of the muscles in their affected wrist and hand which leads to a permanently clenched, painful hand. A contracture is often treated by therapists who use hand splinting to prevent it occurring or slow down its progression. Despite their wide use, there has not been research completed to investigate whether or not splinting prevents contracture in people following stroke. In fact, this project will be the first of its kind in the world and is therefore vital to stroke rehabilitation. The study is a multi-centre, randomised controlled trial that will measure the effect of hand-splinting in two positions on the prevention of contracture, functional use of the hand, and quality of life.

Conditions
-----------------
Cerebrovascular Accident

Intervention / Treatment
-----------------
* Device: hand splint


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: first ever stroke score of <1 on Motor Assessment Scale item 6 Exclusion Criteria: comorbidity resulting in previous contracture of the wrist/hand

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

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: hand splint|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
-----------------
splints, Occupational Therapy
Treatment of Abdominal Abscesses With or Without Fibrinolysis

Study Overview
=================
Brief Summary
-----------------
The objective of this study is to evaluate the utility of fibrinolysis when draining an abdominal abscess as defined by length of stay after drainage.

Detailed Description
-----------------
The hypothesis is that fibrinolysis of a abscess will shorten hospital stay compared to drainage alone.

Official Title
-----------------
Treatment of Abdominal Abscesses With or Without Fibrinolysis

Conditions
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Abdominal Abscess, Tissue Plasminogen Activator

Intervention / Treatment
-----------------
* Procedure: Tissue plasminogen activator abscess flush
* Procedure: Saline flush of abscess


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients under age 18 found to have an abscess in their abdomen related to perforated appendicitis that requires a drain either prior to or after appendectomy. Exclusion Criteria: Patients with known immune deficiency per medical record review Patients with another condition affecting surgical decision making or recovery Patients with drain unable to be placed

Ages Eligible for Study
-----------------
Maximum Age: 17 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: Saline only flush of abscess<br>Saline alone used to flush abscess | Procedure: Saline flush of abscess<br>* Thirteen ml of saline is used to flush abscess at time of drain placement and twice daily thereafter.<br>* Other names: Standard saline flush of abscess;|
| Experimental: Saline plus tPA flush of abscess<br>Saline plus tPA used for abscess flush | Procedure: Tissue plasminogen activator abscess flush<br>* Thirteen ml of 10% tPA in saline at time of drain and twice daily thereafter.<br>* Other names: fibrinolytic abscess flush;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Length of hospital stay | Length of time required for meeting discharge criteria | 1-2 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
tPA, abscess
Multidisciplinary Approach and Counseling of the Obese Patient Before and After Bariatric Surgery

Study Overview
=================
Brief Summary
-----------------
The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. These interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. This will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.

Detailed Description
-----------------
The project consists of qualitative interviews with all the members of the obesity team (endocrinologist, bariatric surgeon, dietician, psychologist,..) in different Flemish hospitals. These interviews have the aim to gain insight into the current practice about counseling patients with bariatric surgery, with a focus on medication counseling. We will do a benchmarking and also qualitative analyses of the interviews using Nvivo 10. This will make it possible to assess the strengths and weaknesses in the current practice of obese patients who will undergo and have undergone bariatric surgery.

Official Title
-----------------
Multidisciplinary Approach and Counseling of the Obese Patient Before and After Bariatric Surgery: Qualitative Interviews

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

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All the members of the obesity team should be prepared to participate in the study
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 |
| --- | --- | --- |
| Difference between multidisciplinary approach in bariatric surgery population in Flanders and the guidelines | We will do a benchmarking and a qualitative research to give an overview of the counseling of obese patients before and after bariatric surgery and to identify the barriers of to a multidisciplinary approach in the counseling of bariatric surgery. | The interviews will be performed once |
Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

Study Overview
=================
Brief Summary
-----------------
People with epilepsy are at a higher risk for sudden unexpected death than the general population. Sudden unexpected death in epilepsy (SUDEP) is a major cause of death in this population, accounting for 10-50% of deaths for those with epilepsy. The risk for SUDEP is particularly high for those with refractory epilepsy. Several lines of evidence support a cardiac mechanism for SUDEP. This study plans to determine: the frequency and types of cardiac arrhythmias that occur in this population and whether these are increased above the general population in the same age group. Additionally, these data will be correlated to specific clinical data, including seizure history, anticonvulsant medications, and any accompanying clinical symptoms.

Detailed Description
-----------------
By employing long-term electrocardiographic monitoring, this study plans to determine: the frequency and types of cardiac arrhythmias that occur in patients with uncontrolled seizures and whether these are increased above the general population in the same age group. The specific aims: Identify the types, frequency, and duration of cardiac arrhythmias that occur in patients with refractory epilepsy and compare these data to available normative data. Correlate abnormal heart rates and rhythms to specific clinical data: seizure type, seizure frequency, probable location of seizure onset in the brain, when such data are available, duration of seizures, and type(s) and number of anticonvulsant medications being used. Correlate cardiac arrhythmias to clinical symptoms

Official Title
-----------------
Cardiac Rhythm Abnormalities in Patients With Refractory Epilepsy at High Risk for Sudden Death

Conditions
-----------------
Refractory Epilepsy, Arrhythmia, Sudden Death

Intervention / Treatment
-----------------
* Device: Medtronic REVEAL


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Refractory epilepsy Exclusion Criteria: Other pre-existing heart conditions

Ages Eligible for Study
-----------------
Minimum Age: 16 Years
Maximum Age: 49 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Medtronic REVEAL|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
-----------------
Epilepsy