linjc16/ctgov huggingface dataset:
The Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin

Study Overview
=================
Brief Summary
-----------------
The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy

Detailed Description
-----------------
children who are suspected to have penicillin allergy due to a suspected allergic reaction during penicillin treatment are sent for allergy investigation to role out allergy. Patients go through penicillin test and if negative are challenged by oral administration under medical observation. The investigators would like to check the incidence among our pediatric pediatric patients.

Official Title
-----------------
The Frequency of Positive Challenge Test to Penicillin in Children Suspected to Have Allergy to Penicillin

Conditions
-----------------
Penicillin Allergy

Intervention / Treatment
-----------------
* Other: penicillin test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Children older then 6 month with suspected penicillin allergy Exclusion Criteria: Children under 6 month old

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 18 Years

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: 1<br>penicillin test and challenge | Other: penicillin test<br>* children are tested for penicillin allergy and then challenged with penicillin P.O.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of reactions during penicillin challenge tests among children with suspected penicillin allergy | To find out how many children are actually true allergic to penicillin | one year |
Patient Preference in Blood Pressure Therapy

Study Overview
=================
Brief Summary
-----------------
Written surveys of patients with high blood pressure are designed to determine how they would likely decide if, in addition to taking medication, they had another option to treat their hypertension. The alternative treatment option is renal sympathetic denervation using catheter ablation. This new treatment method is not yet used in the standard care. Currently, studies are being conducted in specific centers to demonstrate the efficacy of this treatment. Questionnaires are used to determine the preference of patients for one or the other option of hypertension treatment. So far, there are no findings.

Official Title
-----------------
Patient Preference in Blood Pressure Therapy: Questioning of Patients With Hypertension

Conditions
-----------------
Arterial Hypertension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: untreated Hypertension treated Hypertension with one or more medications Exclusion Criteria: illiteracy

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Preference of treatment | Questionnaires | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
renal denervation, preference, shared decision making, Hypertension
To Evaluate the Impact of Oral Flecainide on Quality of Life in Patients With Paroxysmal Atrial Fibrillation

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate the management of paroxysmal atrial fibrillation with controlled release flecainide on patient's quality of life.

Official Title
-----------------
Impact of Oral Controlled Release Flecainide Acetate Capsules on Health-Related QoL in Patients With Paroxysmal Atrial Fibrillation

Conditions
-----------------
Atrial Fibrillation

Intervention / Treatment
-----------------
* Drug: Flecainide controlled release


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: In sinus rhythm at treatment initiation Experienced symptomatic AF episodes Left ventricular ejection fraction of at least 40% Females of child bearing potential must be using reliable method of contraception Exclusion Criteria: Intolerance and/or failure of previous therapy with flecainide immediate release Currently receiving >200mg/day flecainide immediate release Severe symptoms during episodes of arrhythmia History of other cardiac conditions/abnormalities Heart surgery within the last 2 months Renal failure Pregnant or lactating females Significant extra cardiac or systemic disease Abnormal electrolyte levels Receiving defined cardiac and/or other treatments

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


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Flecainide controlled release|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To assess the effect of Flecainide CR on patient-perceived health-related QoL (Quality of Life). |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| assessment of treatment success based on an efficacy/safety composite criterion; |  |  | 
| assessment of the relationship between QoL changes and outcomes related to safety and efficacy; |  |  | 
| assessment of cardiac safety of Flecainide CR through clinical examination, cardiac adverse events,12-lead paper ECG, and cardiac ultrasonography; |  |  | 
| assessment of the non-cardiac safety of Flecainide CR through questioning, non-cardiac adverse events and clinical examination; |  |  | 
| evaluation of the course of the disease by the time to the first recurrence of a PAF episode and the subjective symptomatology (duration and severity of PAF episodes). |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Tambocor, Paroxysmal Atrial Fibrillation, Quality of Life
Acute Exercise and Pancreatic Endocrine Function

Study Overview
=================
Brief Summary
-----------------
Subjects with type 2 diabetes will be stratified into two-quantiles based on ambient hyperglycemia (fasting glucose and HbA1c) and then the effects of a single aerobic exercise bout (1-hour at 50%VO2max) on pancreatic endocrine function will be determined.

Conditions
-----------------
Type 2 Diabetes

Intervention / Treatment
-----------------
* Behavioral: Exercise


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Previous diagnosis with type 2 diabetes, or newly detected in our screening procedures Age 30-70 years BMI 20-40 kg/m2 Exclusion Criteria: Treatment with insulin Contraindication to exercise as determined by ECG Pregnancy Active weight loss in the previous 6 months Actively engaged in exercise training programs Evidence of chronic pulmonary, cardiovascular, hepatic, renal, or hematological disease

Ages Eligible for Study
-----------------
Minimum Age: 30 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: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Resting Trial<br>Pancreatic endocrine function will be determined the morning following a day where no exercise is performed | |
| Experimental: Exercise Trial<br>Pancreatic endocrine function will be determined the morning following a day where a 1-hour aerobic exercise is performed at 65% of pre-determined HRmax (maximal heart rate measured during an incremental work-load exercise test to volitional exhaustion) | Behavioral: Exercise<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pancreatic endocrine function | Insulin and glucagon secretory responses to intravenous glucose (hyperglycemic clamp 5.4 mmol/l above basal), glucagon-like peptide-1 (0.5 pmol/kg/min), and arginine (5 g injection) will be determined. | 24-hours following a period of rest/exercise |
Impact of Maternal BMI on Plasma Levels of Oxytocin During Labor Augmentation

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to examine the associations between maternal BMI and levels of oxytocin in maternal plasma during augmentation with oxytocin during first stage of labor in term pregnancy.

Detailed Description
-----------------
A translational prospective experimental study in the delivery ward in Linköping. The study population will include women in two BMI groups (underweight/normal weight and overweight/obese) during first stage of labor with singleton full term pregnancy and cephalic presentation.The BMI is calculated from weight and height registered at the first antenatal visit around week 8-12. At the delivery ward, if the women are in need of labor augmentation with oxytocin infusion, a peripheral venous catheter will be placed in the contralateral arm from the arm where oxytocin will be administrated. The oxytocin infusion will be prepared to a concentration of 10 mU/ml and will be given according to a standardized protocol or to an infusion level giving maximum of 5 uterine contractions per 10 minutes. Blood samples for measuring plasma levels of oxytocin will be taken prior to start and before every increase in the rate of oxytocin infusion. The blood samples will be collected through the first stage of labor.

Official Title
-----------------
Impact of Maternal BMI on Plasma Levels of Oxytocin During Labor Augmentation

Conditions
-----------------
Maternal Obesity During Childbirth, Labor; Arrested Active Phase

Intervention / Treatment
-----------------
* Other: blood samples


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Full-term pregnancy (from gestational week 37+0), singel pregnancy, vertex presentation, knowledge in the Swedish language, 18 years and older, known BMI, need of labor augmentation with oxytocin infusion during opening stage. Exclusion Criteria: Not participating in other studies at the delivery ward

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| BMI, oxytocin<br>Repeteadly blood samples will be taken | Other: blood samples<br>* blood samples will be taken repeatedly<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| maternal BMI, were weight and height will be combined to report BMI in kg/m^2 | mass spectrometry | eight hours | 
| level of oxytocin in plasma during oxytocin infusion | mass spectrometry | eight hours | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
labor, obesity, oxytocin
Plasty or Prosthesis to Treat Functional Mitral Regurgitation

Study Overview
=================
Brief Summary
-----------------
Functional Mitral regurgitation is a now well known entity due to tethering of the valve either mono-lateral, as happens in lateral myocardial infarction, or bilateral as happens in dilated cardiomyopathy. Treatment of this pathology, either conserving the valve and addressing regurgitation by mean of restrictive annuloplasty, or implanting a prosthesis remains controversial in terms of mid and long term benefit for the patient. The investigators propose a randomized controlled study to compare the efficacy of both technique in terms of mortality and freedom from reintervention.

Official Title
-----------------
POP Study: Plasty or Prosthesis to Treat Functional Mitral Regurgitation in Low Ejection Fraction Patients; a Randomized Prospective Controlled Study

Conditions
-----------------
Functional Mitral Regurgitation

Intervention / Treatment
-----------------
* Procedure: Plasty
* Procedure: Prosthesis


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: All patients presenting for surgery due to functional mitral regurgitation Exclusion Criteria: Associated Heart Surgery procedures other than CABG, Tricuspid Regurgitation correction, Atrial Fibrillation Correction
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: Plasty<br>Patients treated with restrictive Annuloplasty | Procedure: Plasty<br>* Restrictive Annuloplasty<br>|
| Active Comparator: Prosthesis<br>Patients treated with valve replacement | Procedure: Prosthesis<br>* Valve replacement<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mortality |  | 1 year of follow up after discharge from hospital | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Freedom from reintervention |  | 1 year of follow-up after discharge from hospital | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Functional MItral regurgitation
Septal Positioning of Ventricular Implanted Cardioverter Defibrillator (ICD) Leads

Study Overview
=================
Brief Summary
-----------------
This clinical trial is a multi center, prospective, randomized, parallel study designed to compare septal to apical ICD lead placement.

Detailed Description
-----------------
The primary objective of this clinical investigation is to demonstrate that septal positioning of the right ventricular defibrillation lead is not inferior to the apical positioning in terms of safety and efficacy in a population of ICD recipients.

Official Title
-----------------
Septal Positioning of Ventricular ICD Leads

Conditions
-----------------
Ventricular Tachycardia, Ventricular Fibrillation

Intervention / Treatment
-----------------
* Device: Device Implantation


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age >=18 years Signed written informed consent Approved indication for implantation of ICD / CRT-D device Exclusion Criteria: Preexisting transvenous RV pacemaker or ICD leads Pacemaker dependency without sufficient intrinsic rhythm (≤ 30min-1) Hypertrophic obstructive cardiomyopathy Presence of intra-aortic balloon pump Inotropic drug (not digitalis) necessary for hemodynamic support Inability to perform VF induction testing due to anticipated high risk Condition likely to limit cooperation Unable to give informed consent Pregnancy or planned pregnancy in the next 6 months Patients with planned cardiac surgery within the next 3 months following randomization Patient is currently participating in a clinical investigation that includes an active treatment arm. Acute myocardial infarction within the previous 4 weeks.

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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Apical ICD lead placement | Device: Device Implantation<br>* ICD lead implantation<br>* Other names: pacemaker- and active fixation ICD-leads;|
| Experimental: 2<br>Mid-Septal ICD lead placement | Device: Device Implantation<br>* ICD lead implantation<br>* Other names: pacemaker- and active fixation ICD-leads;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Event free survival of RV-ICD-lead related complications |  | 3 months after implantation |
Renal Magnetic Resonance Angiography (MRA) Study Comparing Dotarem and Time Of Flight (TOF)

Study Overview
=================
Brief Summary
-----------------
The study will evaluate the efficacy and safety of Dotarem enhanced MRA compared to TOF MRA in patients suffering from renal arterial disease.

Detailed Description
-----------------
Each participant will undergo first a TOF MRA followed by a Dotarem-enhanced MRA.

Official Title
-----------------
Evaluation of Dotarem-enhanced Magnetic Resonance Angiography (MRA) Compared to Time-Of-Flight (TOF) MRA in the Diagnosis of Renal Arterial Disease

Conditions
-----------------
Renal Artery Stenosis

Intervention / Treatment
-----------------
* Drug: Gadoterate meglumine (Dotarem)
* Other: Time of Flight Magnetic Resonance Angiography


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male or female, aged more than 18 years, Strongly suspected of having renal arterial disease, Scheduled (or to be scheduled) to undergo arterial catheter-based X-ray angiography examination, Exclusion Criteria: Known grade IV or V chronic kidney disease (GFR<30 mL/min/1.73m²), Contraindication to MRI, Acute renal dysfunction within the 6 months preceding Dotarem®-enhanced MRA examination,

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: Diagnostic
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Dotarem<br>Each subject will receive one injection of Dotarem 0.2 ml/kg. | Drug: Gadoterate meglumine (Dotarem)<br>* Each subject will receive one injection of Dotarem 0.2 ml/kg<br>|
| Other: Time Of Flight Magnetic Resonance Angiography<br>Each subject undergo a TOF MRA | Other: Time of Flight Magnetic Resonance Angiography<br>* Each subject will undergo a TOF MRA<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Non Assessable Renal Artery Segments | For each examination (TOF and Dotarem MRA) the percent of non-assessable segment will be compared | 1 to 7 days | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Renal artery stenosis, Contrast agent, MRA
Diffusion MRI and Growth Plate Injuries: Pilot Study

Study Overview
=================
Brief Summary
-----------------
Children who suffer fractures to the growth plates (physes) of their bones are at risk for premature growth arrest which can lead to long term complications. There is currently no technique to predict who is at risk of growth arrest following a physeal injury. The investigators aim to determine if diffusion MRI (an imaging method to analyze tissue properties) can effectively pick up differences between a healthy growth plate and an injured one. This would allow orthopaedics surgeons to predict which injuries are at a higher risk of growth arrest, so earlier interventions can be done in the orthopaedic clinic.

Detailed Description
-----------------
The purpose of this study is to determine if diffusion MRI can be used for tissue characterization in childhood and adolescent growth plate injuries, and to get a better understanding of the physiologic disturbance of an injured physis

Official Title
-----------------
Diffusion MRI as a Prognostic Tool in Growth Plate Injuries: A Pilot Study to Assess Feasibility

Conditions
-----------------
Fracture

Intervention / Treatment
-----------------
* Other: Diffusion MRI


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Salter-Harris Type II, III, or IV fracture through the distal radius Growth plates are open Ages 8-12 Able to consent in English Exclusion Criteria: All fractures not sustained to distal radius SH Type I or V fracture Injury to contralateral limb Previous injury to distal radius Diseases known to alter bone healing or growth] Contraindications to undergoing an MRI scan

Ages Eligible for Study
-----------------
Minimum Age: 8 Years
Maximum Age: 12 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 |
| --- | --- |
| Physeal Injury - Distal Radius<br>Patients who suffer a physeal fracture of the distal radius will be scanned and compared to their healthy contralateral limb. | Other: Diffusion MRI<br>* Each subject will undergo one diffusion MRI scan to identify characteristics of their physes<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tissue characterization of growth plate using diffusion MRI | Diffusion MRI scan of injured and contralateral (control) physis. | 4-6 weeks following injury | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Fracture, Physeal injury, Diffusion MRI