linjc16/ctgov huggingface dataset:
Prevalence of Renal Failure and Risk Factors in an Unreferred Healthy Population

Study Overview
=================
Brief Summary
-----------------
Blood sample is taken for measurement of serum creatinine, cystatin C, clone V haemoglobin, cholesterol, urine acid, glycemia and CRP. The medical file is gathered. There will be searched for an association between renal function and cardiovascular risk factors and risk factors by exposition to toxic substantia during work.

Official Title
-----------------
Prevalence of Renal Failure and Risk Factors in an Unreferred Healthy Population

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Procedure: Taking blood sample


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 20-55 years Male and female subjects

Ages Eligible for Study
-----------------
Minimum Age: 20 Years
Maximum Age: 65 Years

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

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

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

| Intervention/Treatment |
| --- |
|Procedure: Taking blood sample|A blood sample will be taken.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| A possible association between renal clearance and found cardiovascular risk factors and risk factors by exposition to toxic substantia during work. |  | At time T0 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
No specific condition
Realtime-Elastography (RTE) and Thyroid Nodules

Study Overview
=================
Brief Summary
-----------------
The study is an open, prospective multicenter study. According to the statistical sample size calculation 593 patients with thyroid nodules ≥ 5mm in size will be included in the study. Reference methods are cytology obtained by Fine needle aspiration biopsy (FNAB) or histology obtained by surgery. All patients will receive an B-mode and Duplex ultrasound examination of the thyroid gland, as well as Realtime Elastography of thyroid nodules. Results of B-mode and Duplex ultrasound are compared to Realtime Elastography to evaluate the additional value of Realtime Elastography in the diagnostic work up of thyroid nodules.

Official Title
-----------------
Evaluation of Realtime-Elastography for Differentiation of Thyroid Nodules: a Multicenter Study

Conditions
-----------------
Thyroid Nodules

Intervention / Treatment
-----------------
* Device: Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan
* Procedure: Cytology (FNAB) or Surgery


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: patients with thyroid nodules ≥ 5mm in size and TSH ≥ 0,35µU/ml Cytology obtained by FNAB or thyroid surgery planned age ≥ 18 year signed written consent Exclusion Criteria: Diseases which preclude study accomplishment or put the patient at any risk (e.g. psychiatric diseases) Non-contractually capable persons Pregnancy Lactation

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

| Intervention/Treatment |
| --- |
|Device: Realtime-Elastography, linear ultrasound probe, Hitachi EUB-900, Japan|nan|
|Procedure: Cytology (FNAB) or Surgery|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Realtime-Elastography scores I-IV in thyroid nodules | Scores: I-II: benign; III-IV: malignant nodules. The sensitivity and specificity of Realtime-Elastography for the diagnosis of malignant thyroid nodules will be calculated on the basis of above-specified criteria. Cytology is used as reference method for benign nodules and histology for malignant nodules. |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Comparison of Realtime-Elastography with B-mode and Duplex-Ultrasonography concerning the additional diagnostic information obtained by Realtime-Elastography |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
presenting for FNAB or surgery
Immediate Conversion From Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to investigate safety and tolerability of an immediate conversion from Tacrolimus to everolimus in stable renal allograft recipients. Interest in developing CNI-free regimens using other agents such as the proliferation signal inhibitor everolimus.

Official Title
-----------------
A 6-Month Open Pilot Study to Investigate the Safety and Tolerability of Immediate Conversion From Calcineurin Inhibitor Tacrolimus to Everolimus in Stable Maintenance Renal Transplant Recipients

Conditions
-----------------
Kidney Transplantation

Intervention / Treatment
-----------------
* Drug: Everolimus


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion criteria Primary or secondary renal transplantation in the past 12-36 months. Current immunosuppressive therapy consisting of Tacrolimus together with MMF +/-corticosteroids. Moderately impaired renal function Exclusion criteria Multi-organ recipients or previous transplantation with an organ other than a kidney. Acute rejection episodes in the last 6 months. Other protocol-defined inclusion/exclusion criteria may apply.

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

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

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml | Drug: Everolimus<br>* Initial dose 1.5 mg b.i.d. Target blood trough level 4-10 ng/ml<br>* Other names: Certican;|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Routine safety laboratory |  | At baseline | 
| Routine safety laboratory |  | Week 1 | 
| Routine safety laboratory |  | Month 1 | 
| Routine safety laboratory |  | Week 2 | 
| Routine safety laboratory |  | Week 3 | 
| Routine safety laboratory |  | Month 2 | 
| Routine safety laboratory |  | Month 4 | 
| Routine safety laboratory |  | Month 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| renal function |  | At baseline | 
| renal function |  | Weeks 1, 2 and 3 | 
| renal function |  | Months 1, 2, 4 and 6 | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Kidney, renal, transplantation, tacrolimus, everolimus, stable allograft recipients
Functional Limitations Due To The Foot Involvement In Spondyloarthritis

Study Overview
=================
Brief Summary
-----------------
Seronegative spondyloarthritis (SpA) is a group of rheumatic diseases Foot involvement of the SpA is common and enthesitis, erosive changes or ankylosis are the frequent lesions. The functional status of the SpA patients are usually evaluated globally.The aim of this study is to assess specifically the foot -related functional limitations of the SpA patients.

Detailed Description
-----------------
SpA patients who had foot pain at least for 4 weeks and those having bilateral anteroposterior and lateral feet x-rays will be included into the study. Foot x-rays will be evaluated by a radiologist by using the spondyloarthropathy tarsal radiographic index (SpA-TRI). The foot related functional status of the patients will be determined by the Turkish version of the Foot and Ankle Outcome Score (FAOS).

Official Title
-----------------
FUNCTIONAL LIMITATIONS DUE TO the FOOT INVOLVEMENT IN SPONDYLOARTHRITIS

Conditions
-----------------
Ankylosing Spondylitis, Psoriatic Arthritis

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: SpA patients who had foot pain at least for 4 weeks Those having bilateral anteroposterior and lateral feet x-rays will be included into the study Exclusion Criteria: Patients who had flatfoot Previous foot surgery Any other disorder unrelated to the SpA will be excluded

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

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

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

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The foot-related functional status of SpA patients | The foot related functional status of the subjects will be measured with Foot Ankle Outcome Score (FAOS) | 1 month | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ankylosing spondylitis, Psoriatic arthritis, Foot, FAOS, SpA-TRI
Single-Dose Safety Study of APD791 in Healthy Volunteers

Study Overview
=================
Brief Summary
-----------------
The APD791-001 study is designed primarily to evaluate the safety and tolerability of APD791 when administered as a single oral dose to healthy adult subjects.

Official Title
-----------------
A Randomized, Double-Blind, Placebo-Controlled, Single-Dose Escalation Study to Assess the Tolerability, Pharmacokinetics, and Pharmacodynamics of APD791 Administered to Healthy Adult Subjects

Conditions
-----------------
Healthy

Intervention / Treatment
-----------------
* Drug: APD791


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Healthy adult men and women, ages 19-45 Non smokers Exclusion Criteria: History of a bleeding disorder Recently donated blood or had significant blood loss Current use of a prescription medication Pregnant females

Ages Eligible for Study
-----------------
Minimum Age: 19 Years
Maximum Age: 45 Years

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

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

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

Design Details

Allocation: Randomized
Masking: Quadruple


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: APD791|nan|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety measures to include adverse events, vital signs, 12-lead ECGs, physical examinations, and clinical lab parameters |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetic and pharmacodynamic assessments |  |  | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Healthy adult volunteers
Study to Detect Hypotensive Episodes During Spinal Anesthesia for Cesarean Section Using a Noninvasive Continuous Device

Study Overview
=================
Brief Summary
-----------------
Hypotension after spinal anesthesia for Cesarean section occurs in up to 90% usually under five minutes after local anesthetics administration. These changes are poorly depicted by oscillometric measurements. The investigators hypothesized, that a continuous noninvasive device detects more hypotensive periods with lower blood pressures.

Official Title
-----------------
Hypotensive Episodes During Cesarean Section Detected by a Continuous Non-invasive Arterial Pressure Measurement Device Are Missed by the Oscillometric Blood Pressure Measurement

Conditions
-----------------
Hypotension

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: ASA physical status I or II week of pregnancy >36 Exclusion Criteria: emergency cases

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

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cesarean<br>Women scheduled for elective Cesarean section under spinal anesthesia | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
The Association Between Physical Activity and Pregnancy Rate Following Embryo Transfer

Study Overview
=================
Brief Summary
-----------------
The study examines the association between the amount of physical activity of the patient, ie the number of steps daily / weekly, and the pregnancy rate after embryo transfer.

Detailed Description
-----------------
Many studies have investigated the matter until today and still no reliable information about the relationship between physical activity and / or its intensity and the pregnancy rate after embryo transfer. All patients that would take part in the study will be given a pedometer to measure steps for a month. Measuring steps will begin preparation for embryo transfer and two weeks after. Collected information about pregnancy rate (BHCG positive or negative).

Official Title
-----------------
The Association Between Physical Activity and Pregnancy Rate Following Embryo Transfer

Conditions
-----------------
Pregnancy

Intervention / Treatment
-----------------
* Device: pedometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Participant speaks Hebrew or English speakers The participant is eligible to legally provide informed consent Exclusion Criteria: The Subject in the wheelchair-bound or limited walking Participant refuses to give informed consent

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

Sexes Eligible for Study
-----------------
Male

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

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

Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: high risk for PTD with pedometer<br>Patient with high risk for preterm delivery including short cervix or rapture of membranes | Device: pedometer<br>* patient will cary pedometer<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical activity as assessed by number of steps recorded by pedometer |  | 4 weeks |
LAPAS Study: Insulin Glargine in Type 2 Diabetes Mellitus

Study Overview
=================
Brief Summary
-----------------
The objective of this protocol is to confirm the efficacy and safety profile of Lantus in every day medical practice, in type 2 diabetic patients, have been treated with any other insulin but who did not reach the target of A1c = 7%.

Official Title
-----------------
An Open Therapeutic Observational Evaluation of the Efficacy and Safety Profile of Lantus in Everyday Medical Practice in Type 2 Diabetes Mellitus Patients, Who Start Receiving Lantus - Treated With Any Other Insulin, With A1c>7%

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

Intervention / Treatment
-----------------
* Drug: Insulin glargine (LANTUS)


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients with type 2 diabetes mellitus, Having been treated with any other insulin, but who did not reach the target of A1c=7%. Ability and willingness to perform Self Monitoring Blood Glucose measurement Exclusion Criteria: Will follow the prescribing information (Summary of Product Characteristics). The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.

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 |
| --- | --- |
| Patients with Type II diabetes<br> | Drug: Insulin glargine (LANTUS)<br>* The patients will receive Lantus administered by subcutaneous injection, once daily at any time but at the same time each day. Treatment duration: 4 months.<br>|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Glycolysated Haemoglobin (HbA1c) level reduction |  | Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measure of Fasting Blood Glucose (FBG) level reduction |  | Delta between the treatment start and the end of the study (i.e. 4 months +/- 2 weeks) | 
| Investigator assessment |  | At the end of the study (i.e. 4 months +/- 2 weeks) | 
| Insulin dose |  | At the end of the study (i.e. 4 months +/- 2 weeks) | 
| Patient's satisfaction |  | At the end of the study (i.e. 4 months +/- 2 weeks) |
Physiotherapy Treatment Plan in Allergic Bronchopulmonary Aspergillosis: Case Report

Study Overview
=================
Brief Summary
-----------------
A spirometry study is performed in a patient diagnosed with allergic bronchopulmonary aspergillosis. An initial measurement is carried out and the patient is then put on a four-week physiotherapy treatment plan. Four spirometry measurements were taken to assess different variables and an improvement in all the spirometry values was established.

Official Title
-----------------
Effects of a Respiratory Physiotherapy Treatment Plan in Allergic Bronchopulmonary Aspergillosis: Case Report

Conditions
-----------------
Obstructive Pulmonary Disease

Intervention / Treatment
-----------------
* Diagnostic Test: spirometer


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: woman diagnosis of respiratory insufficiency due to allergic bronchopulmonary aspergillosis over 50 years of age under 80 years of age Exclusion Criteria: male not have a diagnosis of respiratory insufficiency due to allergic bronchopulmonary aspergillosis under 50 years of age over 80 years of age

Ages Eligible for Study
-----------------
Minimum Age: 50 Years
Maximum Age: 85 Years

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

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

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

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: spirometer|different values are measured on the spirometer after training in respiratory physiotherapy.|

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total volume | ml | 3 months | 
| Vital capacity | ml | 3 months | 
| Expiratory reserve volume | ml | 3 months | 
| Inspiratory reserve volume | ml | 3 months | 
| Inspiratory capacity | ml | 3 months | 
| Inspiration time | seconds | 3 months | 
| Expiratory time | seconds | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total time | seconds | 3 months | 
| Percentage inspiratory time | seconds | 3 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Obstructive Pulmonary Disease, Physiotherapy
Change in Heart Rate Variability Prior to Tachyarrhythmia in ICD Implanted Patients

Study Overview
=================
Brief Summary
-----------------
To investigate changes in HRV during the time before a spontaneous episode of ventricular tachyarrhythmia.

Official Title
-----------------
HRV Registry to Investigate Changes During the Time Before a Spontaneous Episode of Ventricular Tachyarrhythmia

Conditions
-----------------
Ventricular Tachyarrhythmia

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: S/P lexos VR/-T,DR/-T implantation Signed patient informed consent Exclusion Criteria: CAF Life expectancy<6 months Impending heart transplant Persistent recurring tachycardia Rhythm disturbances that preclude a meaningful HRV analysis Participation in another study.
Sexes Eligible for Study
-----------------
All

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

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

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Observation<br> | |

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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in RR interval recorded by ICD |  | within an hour before ventricular tachyarrythmia | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
ICD, ICD implanted patients