linjc16/ctgov huggingface dataset:
Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
This is a prospective, non-interventional, open label, multi center, post marketing surveillance study designed to assess the safety, tolerability and efficacy of Linagliptin among Filipino patients with type 2 Diabetes Mellitus (DM) within the study duration of 24 weeks.

Official Title
-----------------
A Post-Marketing Surveillance Study on the Safety, Tolerability and Efficacy of Linagliptin Among Filipino Patients With Type 2 Diabetes Mellitus

Conditions
-----------------
Diabetes Mellitus, Type 2

Intervention / Treatment
-----------------
* Drug: Linagliptin


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria: Filipino of Asian race Patient using Linagliptin within label or locally approved indication. The prescription of Linagliptin to the patient must be in the course of normal clinical practice and independent of the decision to include the patient in the study. Male or female patients more than 18 years old Body mass index less than or equal to 40 Diagnosed with type 2 DM Uncontrolled type 2 DM with fasting blood sugar of more than 126 mg/dl and/or HbA1c more than 7%. Exclusion criteria: Diagnosed with type 1 DM Patients with acute illness requiring hospitalization in the past one month Patients participating in a different study that includes an investigational drug Patients with known hypersensitivity reaction to Linagliptin or any of tis components Pregnant women and those women who have intentions of getting pregnant within the study duration Nursing women Patients with concomitant conditions that contraindicates Linagliptin use as described in its product information

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 |
| --- | --- |
| Linagliptin<br> | Drug: Linagliptin<br>* tablet<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Frequency of Adverse Events and Serious Adverse Events | Frequency of adverse events and serious adverse events in an actual clinical setting, including hypoglycemic events. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline to Week 24 of HbA1c | Change from baseline to week 24 of glycosylated hemoglobin (HbA1c) | Baseline and 24 weeks | 
| Change From Baseline to Week 24 of Fasting Blood Sugar | Change from baseline to week 24 of fasting blood sugar | Baseline and 24 weeks |
Safety and Immunogenicity Study of 3 Vaccinations With TICOVAC in 2 Dosages in Healthy Children Aged Between 6 Months and 3 Years

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to evaluate a) whether the seroconversion rates in children are equivalent after two and/or three partial vaccinations with TICOVAC 0.25 mL and TICOVAC 0.5 mL, and b) whether there is a difference in terms of safety between the two products.

Official Title
-----------------
Multicentre Randomized Double-Blind Phase II/III Study on the Safety and Immunogenicity of Three Vaccinations With TICOVAC in Two Dosages in Healthy Children Aged Between Six Months and Three Years

Conditions
-----------------
Encephalitis, Tick-borne

Intervention / Treatment
-----------------
* Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Male and female children aged between 6 and 47 months No history of any previous TBE vaccination Clinically healthy Informed consent provided by the parents Exclusion Criteria: History of allergic reactions, in particular allergic reactions to one of the components of the vaccine Suffering from a disease that cannot be effectively treated or stabilised Suffering from a disease or undergoing a form of treatment which can be expected to influence immunological functions Suffering from a chronic, degenerative and/or inflammatory disease of the central nervous system HIV-positivity (no special HIV test required for the purpose of the study) Suffering from a febrile disease History of vaccination against yellow fever and/or Japanese encephalitis Participation in another clinical trial

Ages Eligible for Study
-----------------
Minimum Age: 6 Months
Maximum Age: 47 Months

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

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

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

Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: Tick-Borne Encephalitis (TBE) Vaccine (Inactivated)|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
-----------------
Tick-Borne Encephalitis
Early Prediction of Hypocalcaemia Following Thyroid Surgery

Study Overview
=================
Brief Summary
-----------------
150 patients divided into two groups.The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus.

Detailed Description
-----------------
Purpose: The aim of this randomized controlled trial was to validate the results of a previous prospective cohort study conducted in the same surgical unit regarding the use of concomitant intact parathyroid hormone (iPTH) and serum calcium measurement in predicting hypocalcemia after total thyroidectomy. Methods: From January 2014 to January 2015, 150 patients underwent total thyroidectomy in our department and were divided into two groups. The experimental group was submitted at the assay of iPTH six hours after surgery whilst the control group was submitted to a daily assay of serum calcium and phosphorus. Sensitivity and specificity of different serum measurements have been calculated using the Receiver-operator characteristics (ROC) curve.

Official Title
-----------------
Early Prediction of Hypocalcaemia Following Thyroid Surgery: A Prospective Randomized Clinical Trial

Conditions
-----------------
Hypocalcemia

Intervention / Treatment
-----------------
* Other: iPTH
* Other: no dosage of iPTH


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Be submitted to total thyroidectomy during the study period Have signed the informed consent Exclusion Criteria: Lack of inclusion criteria Lobectomy with isthmusectomy or partial or subtotal thyroidectomy Completion thyroidectomy Concomitant hyperparathyroidism was present Concomitant treatment with oral calcium and/or vitamin D prior to surgery
Sexes Eligible for Study
-----------------
All

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental group<br>iPTH at 6 hours after surgery | Other: iPTH<br>* iPTH assay six hours after surgery<br>|
| Other: Control group<br>no dosage of iPTH | Other: no dosage of iPTH<br>* Ca and P on postoperative day 1 and 2<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sensibility and specificity of iPTH and serum calcium measurement | Sensitivity and specificity of serum measurement using the Receiver-operator characteristics (ROC) curve | 1 month |
Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).

Study Overview
=================
Brief Summary
-----------------
The asses and evaluate whether trans apical access for TAVR is associated with apical dysfunction.

Official Title
-----------------
Evaluation of Association Between Apical Dysfunction and Trans Apical Access for TAVR, in Patients With Severe Aortic Stenosis, Undergoing Trans Apical Trans Catheter Aortic Valve Replacement (TAP-TAVR).

Conditions
-----------------
Severe Symptomatic Aortic Stenosis

Intervention / Treatment
-----------------
* Device: MRI test


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Severe aortic stenosis defined as aortic valve area of less than 1 cm2 or index area of 0.6 cm2/m2 by echocardiography. Symptomatic patients with aortic stenosis referred for medically indicated AVR Signed informed consent to participate in the study. Exclusion Criteria: Inability to sign written informed consent. Abnormal Apical dysfunction at baseline LVEF < 20% Pregnancy or breast feeding. Need for emergency surgery for any reason. Any case in which the practicing physician asserts that enrollment in the protocol will

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI test<br> | Device: MRI test<br> <br> |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in left ventricle ejection fraction |  | two months after the surgery |
Patient Blood Management - Use and Outcome

Study Overview
=================
Brief Summary
-----------------
Study the influence of transfusion related Patient Blood Management Program actions on transfusion-related outcome measures and cost.

Detailed Description
-----------------
At the University Hospital of Zurich, an in-house designed monitoring and feedback system was introduced which electronically registers each transfusion of any allogeneic blood product, be it red blood cells, plasma or platelets as well as corresponding laboratory data. Results are reported quarterly to Department heads. The investigator analyzes whether the introduction of this monitoring and feedback system as part of a patient blood management Program has a significant influence on use of allogeneic blood product transfusions and transfusion-related costs, without compromising patient outcome.

Official Title
-----------------
Patient Blood Management - Use and Outcome

Conditions
-----------------
Hemorrhage

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Only case records, all discharged patients of the University Hospital of Zürich Exclusion Criteria: Not discharged from our Hospital.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| All Health Conditions.<br>All Health Conditions. Area of Focus: Transfusions of blood products. | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of transfusions per participant | Participant wich had transfusion will be identified and the administrative, financial and clinical data will be compared to participants without transfusions | participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of transfusion of any blood product per participant | Count of any blood products per case, QM Data | participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years | 
| Cost of any blood product per participant | costs per case | participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years | 
| Survey of Patient Blood Management System | clinical, financial,and administrative data of all participants will be reviewed on the focus on transfusions | participants will be followed form date of hospital entry until date of discharge or date of death up to 3 years | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Patient Blood Management, Red Blood Cells, Platelet
Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients in Magnetic Resonance Imaging

Study Overview
=================
Brief Summary
-----------------
Patients will be recruited from those who will undergo contrast enhanced MRI. Safety and tolerability will be assessed.

Official Title
-----------------
Observational Study on the Safety and Tolerability of Gadobutrol (Gadovist) Among Filipino Patients

Conditions
-----------------
Magnetic Resonance Imaging

Intervention / Treatment
-----------------
* Drug: Gadobutrol (Gadovist, BAY86-4875)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 18 years old and above undergoing contrast enhanced cranial or spinal MRI with Gadobutrol (Gadovist) Exclusion Criteria: History of hypersensitivity reaction to gadolinium containing contrast material Hypersensitivity to any of the ingredients of Gadobutrol (Gadovist) History of hypersensitivity to any other contrast agent Patients with uncorrected hypokalemia Pregnant and lactating women Patients with severe cardiovascular diseases Patients in whom MRI cannot be performed.

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 |
| --- | --- |
| Group 1<br> | Drug: Gadobutrol (Gadovist, BAY86-4875)<br>* Patients who will need to undergo contrast enhanced MRI with gadobutrol (Gadovist)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The primary outcome measures would be safety and tolerability of Gadovist which would be measured by change in Vital signs before and after the procedure and the occurrence of serious or non-serious adverse events |  | Up to 1 hour after MRI | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Magnetic Resonance Imaging (MRI), Observational study, Gadobutrol
Post Authorisation Safety Study of Triaxis as a 5th Dose in 4-6 Year Old Spanish Children

Study Overview
=================
Brief Summary
-----------------
Primary objective: This is a descriptive study and the primary objective is to determine the incidence of injection site and systemic adverse events after Triaxis administration as a 5th dose of tetanus, diphtheria and acellular pertussis vaccine in 4-6 year old children

Official Title
-----------------
Observational Post Authorisation Safety Study to Describe the Safety Profile of the Diphtheria, Tetanus, Acellular Pertussis Combination Vaccine, Reduced Antigen Content (Triaxis) as a 5th Dose in 4-6 Year Old Spanish Children

Conditions
-----------------
Diphtheria, Tetanus and Pertussis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Aged 4 to 6 years on the day of enrolment. Have received, on the day of enrolment, immunisation with Triaxis as a 5th dose for diphtheria, tetanus, pertussis vaccination in routine practice in accordance with the Spanish version of the EU SmPC and the Spanish immunisation recommendations. Have received a complete course of immunisation with diphtheria, tetanus and pertussis (4 doses). Participant and participant´s parent/legal representative are able to comply with all study procedures. Written informed consent obtained from at least one parent/legal representative of the participant before the participant is enrolled in the study Exclusion Criteria: Have been previously vaccinated with a 5th dose of tetanus, diphtheria and pertussis. Presence of a contra-indication or cautions to vaccination in accordance with the Spanish version of the EU SmPC: Hypersensitivity to vaccines of diphtheria, tetanus or pertussis, any component of the vaccine and any residual component of the manufacturing process such as formaldehyde and glutaraldehyde that may be present in trace amounts. Encephalopathy of unknown origin within 7 days after a prior immunisation with a vaccine against pertussis. Progressive neurological disorder, uncontrolled epilepsy, progressive encephalopathy if no treatment has been established and the condition is not stable. Acute severe febrile illness or acute infection.

Ages Eligible for Study
-----------------
Minimum Age: 4 Years
Maximum Age: 6 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 |
| --- | --- | --- |
| All Injection Site and Systemic Adverse Events |  | 30 days following vaccination |
Cerebellar Loops and Attention Deficit Hyperactivity Disorder (ADHD)

Study Overview
=================
Brief Summary
-----------------
The aim of this study is to investigate the integrity of connectivity between the neocortex and the cerebellum in the Attention Deficit Hyperactivity Disorder (ADHD). Fibers integrity will be measured using magnetic Resonance Imaging Techniques.

Detailed Description
-----------------
ADHD is a neurodevelopmental trouble characterized by attentional deficits, impulsivity and motor hyperactivity. Morphological neuroimaging studies in ADHD children have revealed cerebellar abnormalities, however data in adults regarding cerebellum alterations are scarce. In this study we will analyse the conectivity of the cerebellum of adults ADHD patients. We will use diffusion tensor imaging (DTI) technique, and morphological data will be compared with the neuropsychological status.

Official Title
-----------------
Alterations of Fronto-Cerebello-Frontal Loops in Attention Deficit Hyperactivity Disorder (ADHD) : A Study Using Magnetic Resonance Imaging (MRI)

Conditions
-----------------
Attention Deficit Disorder With Hyperactivity

Intervention / Treatment
-----------------
* Other: Imaging


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patient with ADHD : Diagnosis of ADHD 18 - 35 years old Healthy volunteer : 18 - 35 years old no ADHD diagnosed Exclusion Criteria: Associated neurological or psychiatric pathologies Pregnant woman MRI counter indication

Ages Eligible for Study
-----------------
Minimum Age: 18 Years
Maximum Age: 35 Years

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

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

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

Design Details

Primary Purpose: Basic Science
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>patients with Attention Deficit Disorder with or without Hyperactivity | Other: Imaging<br>* neuropsychological evaluation and Imaging with magnetic resonance (MRI)<br>|
| Sham Comparator: 2<br>healthy volunteer without Attention Deficit Hyperactivity Disorder | Other: Imaging<br>* neuropsychological evaluation and Imaging with magnetic resonance (MRI)<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Fractional anisotropy coefficient if fronto-cerebello-frontal loops. |  | visite 1 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Attention, Deficit, Disorder, Hyperactivity, cerebellum, alteration, fronto-cerebello-frontal loops
Determinants of Quality of Life Related to Health in Alzheimer Disease

Study Overview
=================
Brief Summary
-----------------
Study the factors that explain Health-Related Quality of Life (HRQL) in patients with Alzheimer disease including: The influence of the environment (physical and human) on Health-Related Quality of Life (HRQL), The influence of non-drug and drug treatments on Health-Related Quality of Life (HRQL), The influence of formal and informal help mobilized, The influence of interactions patient - caregiver on Health-Related Quality of Life (HRQL), The influence of the ratio necessary cost on available resources on Health-Related Quality of Life (HRQL)

Conditions
-----------------
Alzheimer Disease

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with Alzheimer disease (DSM IV and NINCDS-ADRDA) Patients with MMSE (Mini Mental State Examination) > or = 10 Out patients Exclusion Criteria: Severe sensory disturbances, Non French speaking

Ages Eligible for Study
-----------------
Minimum Age: 75 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 |
| --- | --- | --- |
| Health-Related Quality of Life (HRQOL) Assessment |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Dementia - Alzheimer - Quality of life