linjc16/ctgov huggingface dataset:
Physiological Response to Exercise: Sensor Evaluation at Specified Exertions

Study Overview
=================
Brief Summary
-----------------
Assessment of sensor parameter in patients with heart failure.

Detailed Description
-----------------
Evaluate the correlation of specific sensor parameters with clinical reference measurements in patients with heart failure.

Official Title
-----------------
Physiological Response to Exercise: Sensor Evaluation at Specified Exertions

Conditions
-----------------
Heart Failure

Intervention / Treatment
-----------------
* Device: SRD-1 conversion


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: COGNIS CRT-D model N119 or N120, functional bipolar leads: RA, RV, and LV lead all implanted for a minimum of 30 days Prescribed to optimal pharmacologic therapy for heart failure for at least 30 days prior to enrollment Age 18 or above, or of legal age to give informed consent specific to state and national law Exclusion Criteria: Documented HF decompensation, as defined by a hospitalization or greater than a doubling of baseline diuretic dose due to worsening HF, within the last 3 months Patients who are pacemaker dependent Creatinine ≥ 2.5 mg/dL test within the last 3 months Requires assistance walking, for example a cane or walker Have an atrial tachyarrhythmia that is permanent or persistent Have moderate to severe chronic pulmonary disease as defined by FEV1 < 55% predicted Documented life expectancy of less than 6 months Patients at an unreasonable risk of not being able to reach the investigational center in case of an emergency, per physician discretion Enrolled in any concurrent study

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 |
| --- | --- |
| Right Ventricular Cohort<br>Right Ventricle wtih SRD-1 conversion | Device: SRD-1 conversion<br> <br> |
| Left Ventricular Cohort<br>Left Ventricle with SRD-1 conversion | Device: SRD-1 conversion<br> <br> |
| Right Atrium Cohart<br>Right atrium cohort with SRD-1 conversion | Device: SRD-1 conversion<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Effect of High Dose Glucocorticoid Steroids on Myocardial Function

Study Overview
=================
Brief Summary
-----------------
Long term steroid exposure, as in Cushing's disease, causes myocardial dysfunction, hypertrophy and fibrosis in addition to causing obesity, hypertension and glucose intolerance. The aim of our study was to verify if short-term high-dose exogenous steroid therapy adversely effects the heart.

Detailed Description
-----------------
Patients eligible for high dose steroid therapy due to inflammatory diseases were offered to participate in this study. The minimal total intravenous dose was 375 mg prednisone, and the daily steroids were divided into 2-3 doses. To determine the steroids' effect on myocardial function the echocardiographic studies included estimation of global and segmental longitudinal strain. Each patient had a baseline echocardiographic study performed before high-dose steroid therapy was initiated and again immediately after it. A follow-up echo study was performed after completion of a 3-month low-dose steroid therapy period. The paired 2-tailed t-test was used to compare group means

Official Title
-----------------
The Effect of High Dose Glucocorticoid Steroids on Myocardial Function

Conditions
-----------------
High-dose Steroids, Myocardial Function, Longitudinal Strain

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age above 18 Patient with rheumatic disease that need high dose steroids due to exacerbation Patient whom echocardiographic study can be performed with a good quality Exclusion Criteria: age below 18

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 |
| --- | --- | --- |
| determine the steroids' effect on myocardial function the echocardiographic studies included estimation of global and segmental longitudinal strain | the aim of the study was to verify if the reported adverse effect of long-term endogenous cortisol excess on LV systolic and diastolic function occurs after short-term, high-dose, exogenous steroid therapy as well.Patients with inflammatory diseases in internal medicine department who needed treatment with high dose steroids recruited to the study baseline echocardiographic study performed before high-dose steroid therapy was initiated. A second study was performed after completion of the high-dose protocol and scheduled for a third echocardiographic study after completion of a 3-month low-dose steroid therapy period or immediately after termination of steroid therapy if it was during the 3-month period . global and segmental longitudinal strain measured by echo in addition to standard echo measures .the aim to see if high dose steroids use accompanied by echocardiographic changes as seen in Cushing disease | two years |
Novartis Pandemic Influenza A (H1N1) Vaccine(s) Observational Comparative Safety Study

Study Overview
=================
Brief Summary
-----------------
The primary objective of this observational, comparative safety study is to evaluate the safety of the Novartis Pandemic Influenza A (H1N1) vaccine in pregnant women and their off spring, followed for up to 3 months of age as compared to pregnant women who have not received the Novartis Pandemic Influenza A (H1N1) vaccine. This study will be conducted at investigative sites within the Netherlands, Italy, and Argentina.

Official Title
-----------------
A Post-Marketing, Observational, Comparative Safety Study of the Novartis Pandemic Influenza A (H1N1) Vaccine(s) in Pregnant Women Versus Non-Vaccinated Pregnant Women

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

Intervention / Treatment
-----------------
* Other: Non-intervention observational study


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Currently pregnant OR was pregnant following the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest and have already experienced a pregnancy outcome Consents to participate in the study Exclusion Criteria: Is not currently pregnant OR was not pregnant at the time of or after the introduction of the Novartis Pandemic Influenza A (H1N1) vaccine in the country of interest Does not consent to participate in the study Has received a non-Novartis pandemic influenza vaccinee
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 |
| --- | --- |
| Pregnancy women<br>Comparison of pregnancy outcomes between (Novartis) H1N1 vaccinated women and (Novartis) H1N1 unvaccinated women. | Other: Non-intervention observational study<br>* Non-intervention observational study<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Normal live-born delivery |  | 3 months follow-up on all live births | 
| Spontaneous and elective abortions |  | 3 months follow-up on all live births | 
| Congenital malformations |  | 3 months follow-up on all live births | 
| Pre-term birth (prematurity) |  | 3 months follow-up on all live births | 
| Low birth weight |  | 3 months follow-up on all live births | 
| Neonatal mortality |  | 3 months follow-up on all live births | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maternal complications of gestational diabetes, preeclampsia, maternal death |  | During pregnancy and post delivery |
Executive Function in Learning in Children With Attention Deficit Hyperactivity Disorder (ADHD) Receiving Medical Treatment Alone Compared to Children Receiving Additional Treatment to Improve Learning Strategies

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine whether there is a difference in executive function in learning in children with ADHD receiving medical treatment alone to the executive function in children receiving, in addition to medical treatment in learning strategies.

Conditions
-----------------
ADHD

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Normal development for age ADHD Exclusion Criteria: Low compliance Developmental delay Chronic disease

Ages Eligible for Study
-----------------
Minimum Age: 6 Years
Maximum Age: 15 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 |
| --- | --- |
| Combined Therapy<br>ADHD Medication and Learning Strategies Treatment | |
| ADHD Medication Treatment<br>Control group | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Level of Executive Functioning | Brief Behavior Rating Inventory of Executive Function will be administered | One year |
Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Study Overview
=================
Brief Summary
-----------------
Pharmacokinetics of cefazolin in children undergoing cardiac surgery.

Official Title
-----------------
Cefazolin Dosing in Children Undergoing Cardiac Surgery With Cardiopulmonary Bypass

Conditions
-----------------
Cardiopulmonary Bypass

Intervention / Treatment
-----------------
* Procedure: blood and tissue sampling


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: pediatric patients undergoing cardiac surgery with cardiopulmonary bypass minimum weight 1.8 kg intra-arterial or intravenous access other than the drug infusion line available for blood sampling (arterial line is preferred) Exclusion Criteria: no catheter in place for blood sampling absence of parental/patient consent known hypersensitivity to cefazolin

Ages Eligible for Study
-----------------
Minimum Age: 0 Days
Maximum Age: 15 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 |
| --- | --- |
| Cefazolin<br>patients receiving cefazolin as part of routine clinical care | Procedure: blood and tissue sampling<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Assessment of the time during which the unbound cefazolin concentration is above the MIC of S. aureus (fT>MIC) with the current dosing regimen |  | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Optimalisation of the cefazolin dosing regimen to aim for a target unbound cefazolin concentration above the MIC of S. aureus during surgery |  | 3 years |
Switching HIV-1 Infected Subjects From a Highly Active Anti-Retroviral Treatment (HAART) Regimen Dosed Twice Daily or More Frequently to a Once-Daily Regimen

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to demonstrate that virologically controlled HIV-infected individuals can successfully switch from a standard-of-care regimen dosed twice-daily or more frequently to a simpler once-daily (QD) regimen while maintaining virologic control, as evaluated by the proportion of subjects who continue to have plasma HIV-1 levels <50 copies/mL after switching to a QD regimen.

Official Title
-----------------
A Phase 3 Study Switching HIV-1 Infected Subjects With an Undetectable Viral Load From a HAART Regimen Dosed Twice Daily or More Frequently to a Once-Daily HAART Regimen

Conditions
-----------------
HIV Infections

Intervention / Treatment
-----------------
* Drug: stavudine extended-release, lamivudine, efavirenz


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Documented HIV infection 18 years of age or older and weigh at least 40 kg Two plasma HIV RNA levels below the limit of quantification (one at least 90 days prior to the screening visit and one within 30 days of the patients baseline visit) Currently receiving a standard-of-care HAART regimen with at least one agent being dosed twice-daily or more frequently Exclusion Criteria: Pregnancy, breastfeeding or plans to become pregnant during the study period Any prior documented virologic failure to one or more HAART regimens Active AIDS-defining opportunistic infection or disease Proven or suspected acute hepatitis within 30 days prior to study entry

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: stavudine extended-release, lamivudine, efavirenz|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Efficacy at week 48 |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety, tolerability and efficacy at weeks (wks) 24 and 48; Effect on lipids at wks 24 and 48; Adherence, quality of life changes, treatment satisfaction and preference at wks 12, 24 and 48 |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
HIV-AIDS
Using Mass Spectrometry (EasyM) Detecting Minimal Residual Disease (MRD) in Multiple Myeloma

Study Overview
=================
Brief Summary
-----------------
The presence of minimal residual disease (MRD) is an important prognostic factor for multiple myeloma, while M-protein is a widely accepted biomarker used for multiple myeloma (MM) diagnose. Detecting MRD by monitoring M-protein using mass spectrometry (MS) is promising due to its high analytical sensitivity. To evaluate the correlation between MS-MRD and overall disease burden, over 60 patients with 500+ samples were identified for this study. The M-protein sequence and the patient-specific M-protein peptides of each patient were obtained by de novo protein sequencing platform using the diagnostic serum (> 30g/L). The follow- up samples were then measured by a parallel reaction monitoring (PRM) assay.

Official Title
-----------------
Clinical Utility of Mass Spectrometry (EasyM) for Detecting Minimal Residual Disease (MRD) by Monitoring Serum Monoclonal Immunoglobulins in Multiple Myeloma

Conditions
-----------------
Multiple Myeloma

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Subjects with available baseline and sequential serum samples. Exclusion Criteria: Subjects without baseline and sequential serum samples.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 85 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 |
| --- | --- | --- |
| Quantitative measurement of M protein | Detecting the M protein concentration and its dynamic change curve | From June 6, 2022 to December 31, 2022 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| sequence detection of M protein | Detecting the M protein sequence in each person | From December 31, 2021 to May 31, 2022 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
mass spectrometry, serum immunoglobulin, minimal residual disease, MRD, EasyM, M protein
Oral Care Study of Postoperative Infections

Study Overview
=================
Brief Summary
-----------------
Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care

Detailed Description
-----------------
Reduce the incidence of post-operative infections after ENT surgery and flap reconstruction by performing preoperative oral and dental care

Official Title
-----------------
Analysis of the Impact on the Incidence of Postoperative Infections (at the Surgical Site, Flap and Lung) and on the Length of Stay of Oral Care Before Surgery on the ENT Sphere With Flap Reconstruction

Conditions
-----------------
Cancer, Mouth

Intervention / Treatment
-----------------
* Procedure: Preoperative oral care


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ENT surgery with free flap reconstruction Exclusion Criteria: Allergy to chlorhexidine

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 90 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 |
| --- | --- |
| preoperative oral care<br> | Procedure: Preoperative oral care<br>* tooth brushing and mouthwash with chlorhexidine 0,2% five day before surgery<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| incidence of postoperative infections | incidence of postoperative infections | through study completion, an average of 1 year |
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Liver Cancer

Study Overview
=================
Brief Summary
-----------------
Primary: To compare the efficacy of TACE and TAIE. Secondary: To compare the side effects of TACE and TAIE. The outcome measurements include survival benefit and tumour regression induced by the two therapies.

Official Title
-----------------
A Comparative Study of the Efficacy of Transcatheter Arterial Chemoembolization (TACE) and Transcatheter Arterial Pegylated Interferon Embolization (TAIE) for Hepatocellular Carcinoma

Conditions
-----------------
Carcinoma, Hepatocellular

Intervention / Treatment
-----------------
* Procedure: Transcatheter Arterial Chemoembolization (TACE)
* Procedure: Transcatheter Arterial Pegylated Interferon Embolization (TAIE)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Confirmed hepatocellular carcinoma not suitable for surgery Exclusion Criteria: Portal vein thrombosis Severe arteriovenous shunt Bilirubin level > 50 umol/mL Prothrombin time > 5 seconds

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

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

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

| Intervention/Treatment |
| --- |
|Procedure: Transcatheter Arterial Chemoembolization (TACE)|nan|
|Procedure: Transcatheter Arterial Pegylated Interferon Embolization (TAIE)|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| regression of tumour size |  | assessment every 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| side effects |  | every treatment given every 8 - 12 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Hepatocellular carcinoma
CPAP for Infantile Pompe Disease

Study Overview
=================
Brief Summary
-----------------
Patients with infantile onset Pompe disease will be trained with continuous positive airway pressure to see if hypernasality can be improved.

Official Title
-----------------
Efficacy of Continuous Positive Airway Pressure of Treatment of Hypernasality of Children With Infantile Pompe Disease

Conditions
-----------------
Pompe Disease

Intervention / Treatment
-----------------
* Procedure: continuous positive airway pressure


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: confirm as Pompe disease Age 4 and can speak 2-words sentence by order mild to severe hypernasality have regular speech therapy for 8 weeks or longer Exclusion Criteria: (1）hearing loss （2）congenital pharyngeal or laryngeal structure anomalies including cleft palate （3）cerebral palsy （4）recent otitis media effusion （5）very severe hypernasality （6）use non-invasive ventilator

Ages Eligible for Study
-----------------
Minimum Age: 4 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: CPAP training<br>Patients will be instructed and follow the continuous positive airway pressure (CPAP) training procedure | Procedure: continuous positive airway pressure<br>* CPAP training for muscle strength<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| decrease in hypernasality | score hypernasality degree and compare | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| increase in speech intelligibility | score speech intelligibility degree and compare | 6 months |